Clinical GuidelinesIndexed for Doctors.

Clinical practice guidelines for telesurgery, 2nd Edition : Committee for the Pr

This document outlines the clinical practice guidelines for telesurgery in Japan (2nd Edition). It details requirements for surgical teams, facilities, and communication networks for three types of telesurgery: telementoring, telesurgical support, and full telesurgery. It provides specific safety, information security, and legal accountability standards.

Stage IV Non-Small Cell Lung Cancer without Driver Alterations

In 2022, ASCO launched living clinical practice guidelines for systemic therapy for patients with stage IV NSCLC with and without driver alterations. This version (2026.3.1) reviews evidence from a routine literature search up to January 21, 2026, and provides updated recommendations on new therapeutics, such as the inclusion of retifanlimab plus platinum-based chemotherapy as a first-line option.

Global Strategy for Asthma Management and Prevention

Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. It imposes a massive global health burden. The GINA Strategy Report provides an evidence-based approach to the diagnosis, assessment, and personalized management of asthma to achieve long-term symptom control, minimize exacerbation risks, and reduce asthma mortality.

Gene Therapy for Sickle Cell Disease: Practice Recommendations from the American

Gene therapy has emerged as a transformative treatment option for individuals with sickle cell disease (SCD). However, the complexity of patient selection, stem cell mobilization, manufacturing, conditioning, and long-term follow-up underscores the need for standardized, evidence-informed clinical guidance to support shared decision-making and promote safe care delivery.

ESR Essentials: Trauma Team and the Role of Interventional Radiology

These practice recommendations outline three key strategies for integrating Interventional Radiology (IR) into trauma management: embedding IR into multidisciplinary trauma teams with 24/7 availability in Level I centers; performing whole-body contrast-enhanced CT in stable or stabilizable patients to guide immediate embolization of active bleeding; and standardizing embolization protocols and material kits across trauma systems.

European Society of Child and Adolescent Psychiatry (ESCAP) practical guidance f

The guidance outlines practices, procedures, and service environments to promote appropriate, safe, and timely transitions of young people from child and adolescent mental health services to adult mental health services or alternative care settings across Europe.

Patient-Clinician Communication

Effective health care communication is associated with improvements in patient health outcomes. This guideline updates the 2017 ASCO communication guideline by providing oncology clinicians with evidence-based practices for effective communication across the continuum of care, while addressing new challenges such as telehealth, interprofessional communication, and boundary setting.

2025 Korean Guidelines for Cardiopulmonary Resuscitation: Part 10. Education and

The 2025 Korean Guidelines for Cardiopulmonary Resuscitation (Part 10) provide updated recommendations for CPR education and system implementation. Key changes include emphasizing in situ simulation-based training, rapid cycle deliberate practice (RCDP), structured hot and cold debriefings, and the integration of feedback devices. The guidelines also focus on improving public AED utilization, expanding pediatric CPR training, and tailoring education for special populations (women, older adults, and individuals with disabilities) while removing prehospital termination of resuscitation criteria due to domestic legal constraints.

Guidelines for Essential Trauma Care: Second Edition (2026).

Injury is a major cause of death and disability globally, with the highest burden in low- and middle-income countries (LMICs). In 2004, the International Association for Trauma Surgery and Intensive Care (IATSIC) and the World Health Organization (WHO) co-published the Guidelines for Essential Trauma Care (EsTC) to define achievable standards for trauma care resources anywhere in the world. The 2026 publication represents the first update and revision of these Guidelines.

Non-pneumatic compression and its clinical utility in management of lymphedema.

This position statement, endorsed by the American Venous Forum (AVF) and the American Venous and Lymphatic Society (AVLS), assesses the clinical utility of non-pneumatic compression devices (NPCDs) in managing lymphedema and phlebolymphedema. NPCDs use shape-memory alloys (nitinol) to deliver programmable sequential gradient compression while enabling patient mobility. The statement reviews clinical evidence, including two randomized controlled trials (NILE and TEAYS) which show NPCD's superiority over advanced pneumatic compression devices (PCDs) regarding volume reduction, quality of life, and treatment adherence.

Guidance for Canadian Breast Cancer Practice: National Consensus Recommendations

This clinical consensus guideline, developed by the REAL Alliance, outlines national recommendations for the systemic treatment of HR+/HER2- metastatic breast cancer in Canada [2, 15]. Grounded in clinical trial data, the guideline categorizes patients by endocrine sensitivity and genomic markers (such as PIK3CA, ESR1, and BRCA1/2) to define optimal treatment selection and sequencing, including CDK4/6 inhibitors, PI3K/AKT/mTOR inhibitors, oral SERDs, PARP inhibitors, and antibody-drug conjugates, while ensuring patient preferences and quality of life are prioritized [2, 16-18].

Use of Transcutaneous and Percutaneous Ablation for the Treatment of Benign and

Traditional open excisional biopsy for benign breast tumors is effective but can cause scarring and contour changes. Percutaneous therapies like cryoablation and ultrasound-guided excision are comparable in efficacy with better cosmetic outcomes. Minimally invasive ablation is also being investigated and utilized for malignant tumors, offering an alternative to surgical excision for biologically low-risk early-stage breast cancer, particularly in older patients.

Non-Small Cell Lung Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In

In the US, an estimated 229,410 individuals will be diagnosed with lung cancer in 2026, with NSCLC accounting for approximately 87%. The 5-year overall survival rate is around 32%, influenced by factors like histology, disease stage, and the presence of actionable biomarkers.

Evidence-based AGIHO guideline update on prophylaxis of infectious complications

Febrile neutropenia (FN) is an important complication of cancer treatment. This updated evidence-based guideline provides recommendations for the prophylactic use of G-CSF to reduce the risk of FN in adult cancer patients, addressing changes in antineoplastic treatments such as immunotherapy over the past decade.

Intraoral radiographs for the diagnosis, treatment, and follow-up of periodontal

Periodontal diseases affect over 1 billion people worldwide, compromising the tissues that support teeth, with severe disease affecting 24% of Canadians aged 15 and older. Timely and accurate screening and diagnostic tools like intraoral radiographs are crucial for early diagnosis and effective management.

ASCIA Guideline: Infant Feeding for Food Allergy Prevention.

This clinical practice guideline from the Australasian Society of Clinical Immunology and Allergy (ASCIA) provides 16 updated recommendations on infant feeding for the prevention of IgE-mediated food allergies. Key recommendations include introducing solid foods around 6 months of age (and not before 4 months) when developmentally ready, followed shortly by introducing well-cooked egg and age-appropriate peanut. Other common food allergens in the family diet should be introduced in the first year of life and offered weekly once introduced. Standard cow's milk-based formulas are preferred if breastfeeding is not possible, while hydrolyzed, soy-based, or alternative protein formulas are not recommended for allergy prevention. Additionally, mild perioral rashes should not be misidentified as allergic reactions, and testing food on the skin is discouraged.

Management of Acute Compartment Syndrome

This guideline provides evidence-based recommendations for the diagnosis and treatment of acute compartment syndrome in adult patients with extremity trauma, addressing diagnostic criteria, pressure monitoring methods, fasciotomy techniques, and subsequent wound and fracture management.

Joint position statement from the National Psoriasis Foundation Medical Board an

Although testing for latent tuberculosis (TB) infection has been standard practice for psoriasis patients being treated with interleukin (IL) 17 or IL-23 inhibitors, evidence for this practice is weak.

Management of Rotator Cuff Injuries

Shoulder disease is a major cause of musculoskeletal disability in the United States, affecting approximately 8% of all American adults. Rotator cuff pathology is the leading cause of shoulder-related disability seen by orthopaedic surgeons, with surgical volume and associated costs on the rise.

Diagnosis and Management of Adults with Community-Acquired Pneumonia

Understanding of the diagnosis and treatment of adults with community-acquired pneumonia (CAP) has evolved. This document updates evidence-based clinical practice guidelines on four key questions: LUS versus chest radiography, empiric antibacterial therapy with positive respiratory virus testing, antibiotic duration, and systemic corticosteroids.

Accelerated Partial Breast Irradiation

Partial breast irradiation (PBI) delivers radiation locally to the lumpectomy cavity. Accelerated PBI (APBI) condenses treatment from 5-6 weeks to a week or less. This guide helps breast surgeons interpret multiple guidelines on APBI and apply them in clinical practice, noting comparable recurrence rates, reduced toxicity, and improved convenience compared to whole breast irradiation (WBI).

Fertility Preservation in Patients With Cancer

Many cancer-directed therapies, including chemotherapy, radiation, and surgery, pose a risk to reproductive health, making it critical to address fertility concerns as early as possible. This guideline provides a comprehensive approach to assessing, discussing, and offering evidence-based fertility preservation options to adult, adolescent, and pediatric cancer patients to ensure reproductive potential is preserved whenever possible.

Neoadjuvant Chemotherapy for Newly Diagnosed, Advanced Ovarian Cancer

The identification and treatment of patients with ovarian cancer remains a critical challenge. For advanced stages, primary cytoreductive surgery (PCS) has historically been the cornerstone. The emergence of neoadjuvant chemotherapy (NACT) offers an alternative approach to potentially optimize surgical outcomes and reduce perioperative morbidity.

Outpatient Management of Asymptomatic Elevated Blood Pressure

Approximately half of adults in the US are affected by hypertension, and there is wide variation in practice patterns among emergency physicians for managing asymptomatic elevated blood pressure. This clinical policy updates the 2013 ACEP policy by incorporating new evidence to guide emergency physicians on whether initiating antihypertensive medications at ED discharge is safe and effective.

Rehabilitation of Lower Limb Amputation

This clinical practice guideline provides an evidence-based framework for evaluating and managing care for adult patients who have experienced lower limb amputation. It emphasizes a patient-centered, multidisciplinary approach to optimize functional independence, health outcomes, and quality of life.

Perioperative Cardiovascular Evaluation and Management of Patients Undergoing No

Cardiovascular risk factors and disease are prevalent among adults undergoing noncardiac surgery, and perioperative cardiovascular complications are an important cause of morbidity and mortality. Each year, approximately 14.4 million inpatient and 19.2 million ambulatory surgeries are performed in the United States.

Management of Stroke Rehabilitation

This clinical practice guideline provides an evidence-based framework for the rehabilitation of adult stroke survivors, addressing transitions to community, motor therapy, dysphagia, aphasia, spatial neglect, and mental health complications.

Assessment and Management of Patients at Risk for Suicide

The annual rate of death by suicide among adults in the United States increased over the first two decades of the 21st century. This guideline provides updated evidence-based guidance for the assessment and management of patients at risk for suicide within VA and DoD populations.

Management of Patients With Atrial Fibrillation

This guideline provides comprehensive, evidence-based recommendations for the diagnosis and management of atrial fibrillation. It emphasizes a new staging classification, lifestyle and risk factor modifications, stroke risk assessment, and strategies for both rate and rhythm control.

Management of Osteoarthritis of the Hip

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Practical Assessment and Management of Vulnerabilities in Older Patients Receivi

This update builds upon the 2018 ASCO guideline by recommending the mandatory integration of geriatric assessment (GA) and GA-guided management (GAM) for patients 65 and older receiving systemic cancer therapy. Revisions were driven by large randomized clinical trials demonstrating significant benefits in reducing serious chemotherapy-related toxicity.

Systemic Therapy for Melanoma

Systemic treatment for melanoma has changed rapidly since the introduction of ipilimumab in 2011, substantially improving overall and long-term survival. Due to the increasing availability of new therapies, rising melanoma incidence, and treatment costs, rational evidence-based selection of appropriate therapy is essential.

Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer

HER2 testing guidelines focus on identifying protein overexpression or gene amplification to identify patients for HER2-targeted therapies. This update addresses a new indication for trastuzumab deruxtecan for tumors with HER2 IHC 1+ or 2+ without amplification, highlighting the clinical relevance of distinguishing IHC 0 from 1+.

Standards and Guidelines for Perfusion Practice

The 2023 AmSECT Standards and Guidelines for Perfusion Practice outlines 19 mandatory standards and associated guidelines for adult cardiopulmonary bypass (CPB). Key topics include institutionally-based protocols, staffing, safety devices, patient monitoring, anticoagulation, blood flow and management, and crisis management.

Probiotics and Prebiotics

This guideline reviews the history, definitions, mechanisms of action, product safety, and commercial marketplace of probiotics and prebiotics, and outlines the clinical evidence for their applications in specific gastrointestinal diseases.

Surgical Management of Knee Osteoarthritis

Osteoarthritis is a progressive disease causing joint pain, stiffness, and difficulty with movement. This guideline systematically reviews evidence to provide recommendations for its surgical management, prioritizing pain relief and improved function while balancing potential operative benefits and harms.

Perioperative Management Of Antithrombotic Therapy

This guideline updates the 2012 iteration and addresses the perioperative management of patients receiving long-term oral anticoagulant (VKAs, DOACs) or antiplatelet therapy who require elective surgery, focusing on optimal interruption, resumption, and bridging strategies.

Management of Anterior Cruciate Ligament Injuries

This clinical practice guideline evaluates the management of anterior cruciate ligament injuries based on a systematic review of published studies in skeletally mature and immature patients, offering practice recommendations while highlighting gaps in the literature.

Management of Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast

Brain metastases are common in patients with advanced HER2-positive breast cancer, with up to half of patients experiencing brain relapse over time. Improved systemic therapies for extracranial disease have extended survival, creating a need to optimize initial brain metastasis treatments and strategies for subsequent intracranial progression.

Management of Heart Failure

Heart failure remains a leading cause of morbidity and mortality globally. This 2022 guideline replaces the 2013 ACCF/AHA Guideline and the 2017 focused update to provide contemporary, evidence-based approaches to manage patients with heart failure, with the intent to improve quality of care and align with patients' interests.

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With

Since the 2016 guidelines, new data allow for further guidance on the use of genomic tests (e.g., Oncotype Dx, MammaPrint, Prosigna, EndoPredict, Breast Cancer Index) according to the age of patients and the number of involved lymph nodes. This guideline update provides evidence-based recommendations to optimally use currently available biomarkers to guide endocrine and chemotherapy decisions in individuals with early-stage breast cancer.

Diagnosis and Treatment of Low Back Pain (LBP)

This clinical practice guideline updates the 2017 VA/DoD framework for the diagnosis and treatment of acute, subacute, and chronic low back pain in adults. Emphasizing a biopsychosocial model and shared decision-making, the guideline strongly recommends against routine imaging for acute LBP without red flags. It promotes non-pharmacologic treatments like structured exercise, cognitive behavioral therapy, and spinal manipulation over invasive therapies, and expressly advises against the use of opioids and benzodiazepines for LBP management.

Management of Hip Fractures in Older Adults

This guideline offers evidence-based recommendations for the surgical and perioperative management of hip fractures in older adults. It focuses on aspects such as optimal surgical timing, venous thromboembolism prophylaxis, multimodal analgesia, surgical approaches, and the efficacy of interdisciplinary care programs in improving patient outcomes.

Non-Arthroplasty Treatment of Osteoarthritis of the Knee

Osteoarthritis results from an imbalance between breakdown and repair of the tissues in the synovial joint organ. This guideline systematically reviews evidence to make clinical recommendations for non-arthroplasty management.

Management of Hereditary Breast Cancer

This ASCO Rapid Recommendation Update advises that one year of adjuvant olaparib should be offered to patients with high-risk, early-stage, HER2-negative breast cancer and germline BRCA1 or BRCA2 mutations after completing local treatment and chemotherapy, based on the efficacy results from the OlympiA phase III trial.

Treatment of Rheumatoid Arthritis

This guideline updates recommendations for the pharmacologic management of rheumatoid arthritis, addressing treatment with conventional, biologic, and targeted synthetic DMARDs, the use of glucocorticoids, and DMARD use in specific high-risk patient populations.

Metastatic Pancreatic Cancer

This ASCO guideline update provides evidence-based recommendations for second-line and maintenance therapies in metastatic pancreatic cancer. It highlights the use of targeted treatments such as PARP inhibitors (olaparib) for patients with germline BRCA mutations and TRK inhibitors (larotrectinib/entrectinib) for patients with NTRK fusions.

Prevention And Management Of Chemotherapy-Induced Peripheral Neuropathy In Survi

Chemotherapy-induced neuropathy is a serious clinical problem caused by cytotoxic drugs like taxanes and platinums. Symptoms can acute or chronic, causing marked effects on the quality of life and potentially limiting cancer treatments.

Management of Gout

Gout is the most common form of inflammatory arthritis, affecting approximately 9.2 million adults in the US. Despite the availability of effective and inexpensive medications, gaps in quality of care persist. The 2020 guideline was developed using GRADE methodology to update the 2012 recommendations, incorporating new clinical trial evidence regarding treat-to-target strategies, urate-lowering therapies (ULT), and patient preferences to improve gout management.

Use of Transesophageal Echocardiography to Assist with Surgical Decision-Making

Intraoperative transesophageal echocardiography is a standard diagnostic and monitoring tool employed in the management of patients undergoing an entire spectrum of cardiac surgical procedures. Utilizing a protocol as a starting point enables standardization of image acquisition and better patient care.

Use of Multimodality Cardiovascular Imaging in Young Adult Competitive Athletes

This guideline provides a comprehensive framework for using multimodality cardiovascular imaging (TTE, CMR, CTA) to evaluate competitive athletes. It outlines how to differentiate physiological exercise-induced cardiac remodeling from pathologic cardiomyopathies and details the appropriate clinical scenarios for incorporating diagnostic imaging following pre-participation screening or symptom presentation.

Management of Glenohumeral Joint Osteoarthritis

This document addresses the management of patients with primary glenohumeral joint osteoarthritis, evaluating the effectiveness of both non-surgical and surgical approaches to minimize dysfunction and pain.

Opioids in Total Joint Arthroplasty

This clinical practice guideline provides evidence-based recommendations regarding the use of opioids before, during, and after primary total joint arthroplasty (TJA). It highlights the risks of preoperative opioid use, advocates for prescribing the lowest effective quantity at discharge, and details the effects of perioperative opioids.

Multimodality Assessment of Congenital Coronary Anomalies

Congenital coronary artery anomalies are recognized as important lesions with significant potential morbidity and mortality, including sudden cardiac death. Multimodality imaging techniques have replaced cardiac catheterization as the primary tool for characterization of most congenital CA anomalies in children.

Nonsteroidal Anti-Inflammatory Drugs in Total Joint Arthroplasty

This clinical practice guideline provides evidence-based recommendations on utilizing NSAIDs for postoperative pain management and reducing opioid consumption in primary total joint arthroplasty patients.

Gabapentinoids in Total Joint Arthroplasty

This clinical practice guideline evaluates the efficacy and safety of gabapentinoids in primary total joint arthroplasty (TJA). It concludes that while gabapentinoids do not significantly reduce postoperative pain in the perioperative period, pregabalin does reduce opioid consumption. Post-discharge, pregabalin effectively reduces pain and opioid use, whereas gabapentin does not. The guideline advises caution, particularly regarding respiratory depression when used concurrently with opioids and increased risks of confusion and sedation in elderly patients.

Acetaminophen in Total Joint Arthroplasty

This clinical practice guideline evaluates the efficacy and safety of perioperative intravenous and oral acetaminophen for pain management and opioid consumption reduction in patients undergoing primary total joint arthroplasty.

Evidence-based Treatments for Couples with Unexplained Infertility

Up to 30% of couples experiencing infertility are diagnosed with unexplained infertility after a standard evaluation. Since no treatable cause is identified, treatment is by necessity empiric. Commonly used treatments include ovarian stimulation with oral medications or injectable gonadotropins with intrauterine insemination, and in vitro fertilization.

Alcohol Withdrawal Management

This guideline updates previous ASAM guidelines to address current practice concerns and provide clear guidance for consistent treatment practices in the field. It emphasizes risk assessment and proper level of care determination, detailing comprehensive management protocols for both ambulatory and inpatient settings.

Treatment of Opioid Use Disorder

This guideline provides comprehensive, evidence-based recommendations for assessing, diagnosing, and treating Opioid Use Disorder (OUD). It details the appropriate use of FDA-approved pharmacotherapies including methadone, buprenorphine, and naltrexone, managing opioid withdrawal, administering psychosocial interventions, preventing overdoses with naloxone, and tailoring treatments for special populations such as pregnant women, adolescents, and justice-involved individuals.

Management of Growth Hormone Deficiency in Adults and Patients Transitioning fro

Adult growth hormone deficiency is associated with multiple adverse metabolic abnormalities and increased cardiovascular morbidity. This guideline update summarizes current knowledge regarding the accuracy of available GH-stimulation tests, rhGH dosing regimens targeting IGF-1 normalization, and the long-term safety profile of rhGH replacement.

Psychological Practice for People with Low-Income and Economic Marginalization

This APA guideline provides recommendations for psychologists to deliver culturally competent care to individuals experiencing low-income and economic marginalization (LIEM). It covers four main domains: training and education, health disparities, treatment considerations, and the intersection of LIEM with career concerns and unemployment. The document emphasizes the need for practitioners to address social class biases, understand systemic barriers to healthcare access, and utilize flexible, evidence-based treatments tailored to this population.

Evaluation and Management of Obesity Hypoventilation Syndrome

This official American Thoracic Society clinical practice guideline aims to optimize the evaluation and management of adults with obesity hypoventilation syndrome (OHS). Using the GRADE methodology, the multidisciplinary panel formulated five conditional recommendations regarding diagnostic screening with serum bicarbonate, the application of positive airway pressure (PAP) therapy (CPAP or NIV) for both stable outpatient and hospitalized individuals, and the necessity of targeted, sustained weight loss interventions.

Medication-Related Osteonecrosis of the Jaw

Medication-related osteonecrosis of the jaw (MRONJ) is a complication that occurs in 1% to 9% of advanced cancer patients receiving bone-modifying agents (BMAs). It is characterized by exposed, unhealed bone in the maxillofacial region. The guideline seeks to establish standardized definitions, preventive strategies, and management algorithms to optimize oral care and patient outcomes.

Caring for Women and Men Of Reproductive Age with Possible Zika Virus Exposure

This ASRM guideline provides updated preconception counseling and clinical protocols for reproductive healthcare providers treating non-pregnant patients with possible Zika virus exposure. It details testing paradigms, required wait times before attempting conception (e.g., 3 months for men, 8 weeks for women), and specific handling procedures for ART, gametes, and embryos to mitigate the risk of congenital Zika virus infection.

Responsible, Safe, and Effective Use of Antithrombotics and Anticoagulants in Pa

These guidelines provide evidence-based recommendations on the perioperative management of antithrombotic and anticoagulant therapy for patients undergoing interventional pain procedures, stratifying interventions into low, intermediate, and high bleeding risks to minimize adverse events like epidural hematomas and thromboembolisms.

Summary of the International Society for Heart and Lung Transplantation (ISHLT)

This news release from Elsevier, published on December 4, 2017, commemorates the 50th anniversary of the first human heart transplant performed by Dr. Christiaan Barnard on December 3, 1967 [3, 11]. It highlights a special issue of The Journal of Heart and Lung Transplantation (Volume 36, Issue 12) featuring ten editorials and a special feature article on donation after circulatory death (DCD) heart transplants [6, 9, 18]. It outlines the historical evolution of transplant medicine, the introduction of cyclosporine, mechanical cardiac support, and future directions such as xenotransplantation [13, 19-21].

Role of Elastography in the Evaluation of Liver Fibrosis

This guideline provides evidence-based recommendations on utilizing noninvasive imaging tools, specifically vibration-controlled transient elastography (VCTE) and magnetic resonance elastography (MRE), for evaluating liver fibrosis, diagnosing cirrhosis, and ruling out varices across various chronic liver diseases.

Guidelines for local research ethics committees.

This document outlines the Department of Health's 1991 guidelines for Local Research Ethics Committees (LRECs) in the United Kingdom. It establishes the committees' advisory role, expands their review scope to include epidemiological and questionnaire-based research, and details requirements for membership (including lay representation), informed consent, and compensation disclosure.

First Report of National Consensus Guidelines for the Diagnosis and Treatment of

This first national Iranian consensus guideline provides 35 evidence-graded statements for the diagnosis and management of H. pylori infection. Utilizing the GRADE framework, it highlights non-invasive testing for young patients without alarm features, establishes 10-14 days of bismuth quadruple therapy as the first-line treatment due to high clarithromycin resistance, and provides post-treatment monitoring protocols and special considerations for renal/hepatic impairment.

[Preexisting diabetes: Expert consensus from the College of French Gynecologists

This expert consensus provides guidelines for the management of pre-existing type 1 and type 2 diabetes before, during, and after pregnancy. It outlines glycemic targets, monitoring strategies, timing of delivery, and postpartum/neonatal care.

Transforming chronic kidney disease care with telemedicine: expert consensus rec

Chronic kidney disease (CKD) affects 10-13% of adults worldwide and imposes a substantial burden on healthcare systems. Telemedicine has emerged as a key tool to support nephrology care by improving access, continuity, and patient engagement across CKD, dialysis, and transplant pathways. To guide its integration into routine practice, the Italian Society of Nephrology (SIN) convened a multidisciplinary working group to develop expert consensus recommendations on the use of telemedicine in nephrology. The consensus process included moderated meetings, topic-specific task forces, iterative drafting, and review of randomized trials, policy frameworks, and national guidelines. The resulting recommendations address technological and regulatory requirements, organizational models, and clinical applications across CKD management, peritoneal dialysis, hemodialysis, home hemodialysis, kidney transplantation, rare kidney diseases, and telepathology for kidney biopsy interpretation. Key barriers-including infrastructure, digital literacy, and reimbursement-were also examined. Telemedicine was found to be most effective when implemented within hybrid care models supported by certified platforms, trained staff, and integrated workflows. While telemedicine can reduce hospital visits, enable early detection of complications, and enhance patient satisfaction, further research is needed to assess long-term outcomes and cost-effectiveness. These recommendations aim to support equitable, safe, and sustainable implementation of telenephrology within modern healthcare systems.

Society of Critical Care Medicine Guidelines on Caring for Older Adults in the I

Older adults incur over half of ICU days, and this demographic is expected to increase significantly by 2050. They face unique vulnerabilities such as frailty, cognitive impairment, and a higher risk of harm from ICU practices like polypharmacy and immobility. These guidelines offer targeted, evidence-based recommendations for addressing the complex needs of this growing population.

[ESC guidelines on dyslipidemia update 2025 : New recommendations for the practi

The 2025 update of the European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines on dyslipidemia introduce important innovations based on new evidence. The risk assessment is now conducted using the systematic coronary risk evaluation 2 (SCORE2) and SCORE2-OP (older persons), which enable improved stratification, particularly in older individuals. In addition, risk modifiers, such as family history, ethnicity, comorbidities and the biomarkers elevated highly sensitive C‑reactive protein (hs-CRP) or lipoprotein(a) (Lpa), have been introduced. Risk categories have been refined while low-density lipoprotein cholesterol (LDL-C) target values and the principle of stepwise treatment remain unchanged. A major focus is on the acute coronary syndrome: the immediate initiation of high-intensity statin treatment, mostly in combination with ezetimibe is recommended. Increasingly more important are elevated Lp(a) levels and special subgroups: in people with human immunodeficiency virus (HIV), statin treatment is recommended over the age of 40 years regardless of the LDL‑C as well as in high-risk patients undergoing anthracycline treatment. The use of dietary supplements and vitamins for prevention, however, are discouraged. The update reinforces the principle of risk-adapted LDL‑C target values, expands the treatment options and emphasizes the need for early, consistent lipid-lowering with practical recommendations. Das 2025er Update der Leitlinien der European Society of Cardiology (ESC) und der European Atherosclerosis Society (EAS) zur Dyslipidämie bringt auf Basis neuer Evidenz wichtige Neuerungen. Die Risikoabschätzung erfolgt nun über SCORE2 (Systematic Coronary Risk Evaluation 2) und SCORE2-OP (Older Persons), die eine bessere Einstufung insbesondere bei älteren Personen erlauben. Ergänzend werden Risikomodifikatoren – wie familiäre Belastung, Herkunft und Komorbiditäten sowie Biomarker wie erhöhtes hoch sensitives C‑reaktives Protein (hs-CRP) oder Lipoprotein(a) (Lp[a]) – eingeführt. Die Risikokategorien wurden präzisiert, LDL(„low-density lipoprotein“)-C-Zielwerte und das Prinzip stufenweiser Therapie bleiben unverändert. Ein Schwerpunkt liegt auf dem akuten Koronarsyndrom: Hier wird eine sofortige hoch intensive Statintherapie, meist kombiniert mit Ezetimib, empfohlen. Zunehmend wichtig sind erhöhte Lp(a)-Spiegel und spezielle Subgruppen: Bei Personen mit HIV (humanes Immundefizienzvirus) wird ab dem 40. Lebensjahr eine Statintherapie empfohlen, unabhängig vom LDL‑C, ebenso bei Hochrisikopatientinnen und -patienten unter Anthrazyklintherapie. Von Nahrungsergänzungsmitteln und Vitaminen zur Prävention wird dagegen abgeraten. Das Update stärkt das Prinzip risikoadaptierter LDL-C-Zielwerte, erweitert die Therapieoptionen und betont die Bedeutung einer frühen, konsequenten Lipidsenkung mit praxisnahen Empfehlungen.

[SEMERGEN Position Statement on the management of the Oncologic Patient: Compreh

The sustained improvement in cancer survival has highlighted the growing impact of cardiovascular toxicity related to anticancer therapies, which has become a leading cause of non-cancer morbidity and mortality. This position statement aims to provide a practical and standardized framework for the comprehensive management of cardiotoxicity in oncology patients from the perspective of Primary Care (PC) in Spain, acknowledging its pivotal role in prevention, early detection, risk stratification, and long-term follow-up. The document reviews the main forms of cardiovascular toxicity associated with systemic anticancer therapies, as well as local treatments such as thoracic radiotherapy, incorporating current definitions and recommendations from European and international guidelines. A structured model based on the oncology care continuum is proposed, encompassing the initial phase, active treatment, and survivorship, allowing cardiovascular surveillance to be tailored according to baseline risk, type of treatment, and clinical evolution. Special emphasis is placed on early cardiovascular risk assessment, proactive optimization of cardiovascular risk factors and comorbidities, and the establishment of clear referral and coordination pathways between PC, Oncology, Hematology and Cardiology. The central role of PC in the follow-up of long-term cancer survivors is also highlighted, as this growing population remains at risk of late cardiovascular complications that may persist or increase over time. This position statement seeks to promote coordinated, equitable, and patient-centered care, reducing clinical variability and improving cardiovascular outcomes and quality of life for oncology patients within the National Health System.

HRS position statement: Changing the tide in CPR and AED education for students

Out-of-hospital cardiac arrest remains a leading cause of mortality in the United States, but bystander-initiated CPR remains suboptimal due to disparities and inconsistent training. The Institute of Medicine identifies US high school students as a prime target for CPR and AED education.

[Comprehensive rehabilitation guideline for lung transplantation].

To address the lack of standardized rehabilitation protocols in Chinese lung transplantation practice-where significant variations in assessments, interventions, and management modalities compromise patient outcomes-this guideline was jointly developed by the Chinese Thoracic Society, Respiratory Rehabilitation Committee of Chinese Association of Rehabilitation Medicine, Chinese Society of Organ Transplantation, Organ Transplantation Committee of Chinese Association of Rehabilitation Medicine, and the National Center for Respiratory Medicine. A multidisciplinary task force followed the World Health Organization Handbook for Guideline Development and relevant Chinese standards, employing the Delphi method to formulate 16 recommendations addressing 14 clinical questions. These clinical questions encompassed the preoperative pre-rehabilitation, intensive care, sub-intensive care, and long-term rehabilitation phases. Specific topics include preoperative prehabilitation (Q1), postoperative pain management (Q2), early mobilization (Q3), lung-protective ventilation (Q4), noninvasive support after extubation (Q5), prone positioning for graft dysfunction (Q6), and airway clearance (Q7); diaphragm assessment (Q8), inspiratory muscle training (Q9), and dysphagia intervention (Q10); venous thromboembolism prophylaxis (Q11); nutritional (Q12) and psychological (Q13) management; and post-discharge maintenance rehabilitation (Q14). These recommendations advocate an integrated approach encompassing health communication, medication, health devices and technologies, diet and nutrition, lifestyle modifications, and environmental management to optimize recovery and quality of life for lung transplant recipients. 《肺移植全程康复指南》基于循证医学原则和多学科专家共识，围绕术前预康复、围术期重症、术后亚重症及出院后维持性康复四大阶段，整合呼吸治疗、物理康复、营养支持、吞咽功能管理等核心干预措施，最终形成连续性的康复评估与干预路径。指南共纳入14个关键临床问题，形成16条推荐意见，主要涵盖康复评估、个体化康复策略及多学科协作模式等，以促进肺移植受者的功能快速恢复、生活质量改善及长期预后提升，为我国肺移植康复临床实践提供标准化参考。.

The Diagnosis of Primary Ciliary Dyskinesia: Putting The European Respiratory/Am

Primary ciliary dyskinesia (PCD) is a rare inherited disease characterized by progressive lung disease, chronic rhinosinusitis, repeated middle ear infections, laterality defects, and reduced fertility. Diagnosis is often delayed due to symptom heterogeneity, necessitating the use of multiple diagnostic tests. The joint ERS/ATS guidelines provide a unified, evidence-based approach to standardize PCD diagnostics.

American Society for Metabolic and Bariatric Surgery review of endobariatric pro

The provided text does not contain the clinical guideline itself, but rather an author disclosure form for the American Society for Metabolic and Bariatric Surgery, intended for submissions to the journal SURGERY FOR OBESITY AND RELATED DISEASES (SOARD). It outlines the requirements for disclosing relevant financial relationships and conflicts of interest.

[Use of Omalizumab-biosimilars for CRSwNP in the German Health Care System - a P

The GINA 2019 update provides global evidence-based recommendations for the diagnosis, assessment, and management of asthma. A major update is the recommendation against short-acting beta2-agonist (SABA)-only treatment for adults and adolescents, instead recommending inhaled corticosteroid (ICS)-containing controllers to reduce the risk of severe exacerbations. The guideline also details stepwise management, management of severe asthma, pediatric asthma, and asthma-COPD overlap.

2025 Korean Guidelines for Cardiopulmonary Resuscitation: Part 7. Pediatric basi

The 2025 Korean Guidelines for Pediatric Basic Life Support detail updated, evidence-based practices for resuscitating infants and children. Key updates include the strong recommendation for all rescuers to use the two-thumb encircling hands technique for infant chest compressions, the implementation of pediatric early warning systems (PEWS) in hospitals, the approved use of AEDs by lay rescuers for children over 1 year of age, and alternating 5 back blows with 5 chest thrusts for choking infants.

Consensus Document SEPAR-AAMR-ALAT-ASONEUMOCITO-SMNCT on Assessment and Treatmen

The use of new tobacco and nicotine products (electronic nicotine delivery system, heated tobacco, and smoking water pipes) has increased in recent years worldwide. This has led to the emergence of a new smoker profile whose diagnostic and therapeutic approach is different from that of conventional tobacco smokers. The demand for help in quitting these new forms of smoking necessitates the development of guidelines or recommendations that are not currently available. Therefore, the Tobacco Control Group of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and in collaboration with Ibero American societies (AAMR, ALAT, ASONEUMOCITO, SNMCT) have produced a consensus document using the nominal focus group methodology, supported by a narrative review on the approach to smoking in users of electronic nicotine delivery systems (ENDS) and new forms of tobacco. The approach to diagnosing these types of users will be based on variables such as intensity, degree of nicotine dependence, self-efficacy, and motivation, using new scales or questionnaires. Psychological counseling will be based on psychoeducation, motivational interviewing, and cognitive-behavioral therapy. Nicotine replacement therapy, varenicline, cytisinicline, and burpropion are medications to consider for users of these devices.

2025 update on MRD in acute myeloid leukemia: a consensus document from the ELN-

Measurable residual disease (MRD) monitoring has become a critical component in the management of acute myeloid leukemia (AML), to inform prognosis, guide therapy, and serve as a key end point in clinical trials. The 2025 update of the MRD guideline provides a comprehensive and refined framework for MRD assessment, aligned with the European LeukemiaNet (ELN) 2022 genetic risk classification. Developed by members of the ELN AML MRD Working Party, the guidelines incorporate expert consensus determined through a 2-stage Delphi round. They address the clinical implementation of MRD methodologies, technical considerations, integration into clinical trials, and future directions. Importantly, MRD recommendations are tailored to individual prognostic and genetic subgroups. A new qualitative MRD response category, designated as optimal, warning, or high risk of treatment failure, has been introduced to facilitate contextual interpretation of the MRD burden and its clinical relevance. Notably, ultrahigh-sensitivity next-generation sequencing-based MRD assessment is now recommended for FLT3 internal tandem duplication-mutated AML after intensive chemotherapy and before allogeneic hematopoietic cell transplantation. A total of 56 recommendations were formulated, with 53 achieving a high level of consensus (≥90%). These updated guidelines represent a major step forward toward harmonizing MRD assessments in AML and enhancing its clinical utility across diverse treatment settings.

[Diabetic kidney disease (Update 2026) : Guidelines in a collaboration of t

The 2026 update of the Austrian guideline on Diabetic Kidney Disease outlines comprehensive recommendations for screening, diagnosing, and managing renal complications in patients with Type 1 and Type 2 diabetes. It highlights utilizing the Kidney Failure Risk Equation (KFRE) for risk stratification and strongly supports a multifactorial therapeutic approach. Notably, the guideline advocates for integrating novel renoprotective classes, such as SGLT2 inhibitors, GLP-1 receptor agonists, and the non-steroidal mineralocorticoid receptor antagonist Finerenone, emphasizing their ability to delay disease progression and significantly lower cardiovascular and renal risk.

[Animal-assisted interventions (AAI) in intensive care : Position of the German

Animal-assisted interventions (AAI) are increasingly recognized as nonpharmacological adjuncts to intensive care medicine. The aim of this paper by the German Society of Internal Intensive Care and Emergency Medicine (DGIIN) is to summarize the scientific rationale, safety considerations, and implementation recommendations for the use of AAI in intensive care units. Therapeutic effects are attributed to neuroendocrine mechanisms, particularly activation of the oxytocin system and reduction of cortisol levels, which can alleviate anxiety, pain perception, and psychological stress in critically ill patients. Early studies have reported significant reductions in anxiety without an associated increase in nosocomial infections. However, clinical implementation requires well-defined structural, hygienic, and ethical frameworks, including standardized risk analyses, binding hygiene and animal welfare standards, and multiprofessional collaboration integrating intensive care, nursing, infection control, and animal therapy. This paper presents the first systematic recommendations in Germany for the safe and quality-assured integration of animal-assisted interventions into intensive care practice and calls for scientifically accompanied implementation focusing on patient safety, animal welfare, and team well-being. Tiergestützte Interventionen (TGI) stellen zunehmend anerkannte, nichtpharmakologische Ergänzungen der intensivmedizinischen Versorgung dar. Ziel dieser Stellungnahme der Deutschen Gesellschaft für Internistische Intensivmedizin und Notfallmedizin (DGIIN) ist die Darstellung wissenschaftlicher Grundlagen, Sicherheitsaspekte und Implementierungsempfehlungen für den Einsatz von TGI auf Intensivstationen. Therapeutische Effekte beruhen auf neuroendokrinen Mechanismen, insbesondere der Aktivierung des Oxytocinsystems und Reduktion des Kortisolspiegels, wodurch Angst, Schmerzempfinden und psychischer Stress bei kritisch Kranken reduziert werden können. Erste Studien zeigen signifikante Angstreduktionen ohne nachweisbare Zunahme nosokomialer Infektionen. Für den klinischen Einsatz sind jedoch klare strukturelle, hygienische und ethische Rahmenbedingungen erforderlich. Dazu gehören standardisierte Risikoanalysen, verbindliche Hygiene- und Tierwohlstandards sowie eine multiprofessionelle Zusammenarbeit unter Einbindung von Intensivmedizin, Pflege, Hygiene und Tiertherapie. Die Stellungnahme formuliert erstmals in Deutschland systematische Empfehlungen zur sicheren und qualitätsgesicherten Integration tiergestützter Interventionen in die Intensivmedizin und fordert eine wissenschaftlich begleitete Implementierung mit Fokus auf Patient*innensicherheit, Tierwohl und Teamgesundheit.

Electronic Health Records.

An FDI World Dental Federation policy statement outlining the objectives, potential benefits, and key principles (trust, equity, wider research value, interoperability, and multidisciplinary development) for implementing and integrating Electronic Health Records (EHRs) in oral healthcare.

AGA Clinical Practice Update on Diagnosis and Treatment of Hemorrhoids: Expert R

Hemorrhoids only cause significant pain when acutely thrombosed. Internal hemorrhoids are graded according to Goligher's classification based on the degree of prolapse, while external hemorrhoid description remains subjective.

Histological approach and differentiation of Crohn's disease and gastrointestina

The most common causes for ulcero-stricturing diseases of the ileo-cecal region and colon in Southeast Asia are Crohn's disease (CD) and gastrointestinal tuberculosis (GI TB). Diagnosing these conditions is challenging because they share several clinical, endoscopic, radiological and histological features on mucosal biopsies. Therefore, there is a need to standardize the sampling, processing and interpretation of mucosal biopsies to aid clinical decision-making. Recognizing this challenge, core subject experts nominated by the Indian Association of Pathologists and Microbiologists (IAPM), the Indian Society of Gastroenterology (ISG) and the Colitis and Crohn's Foundation, India (CCFI), collaborated to formulate comprehensive recommendations for pathologists regarding optimal biopsy protocols, histological interpretation and reporting for differentiating CD from GI TB. A structured Delphi process was followed. The recommendations from the core domain expert groups were based on discussions, brainstorming sessions and extensive literature reviews conducted over three virtual group meetings, multiple online voting sessions and one physical meeting involving all experts. This document is expected to standardize the practice of luminal gastroenterology by providing a ready reference for budding specialists and pathologists, thereby promoting uniformity in practice. These multi-society, evidence-based and practically applicable recommendations developed by core subject experts aim to promote uniformity and confidence in pathology reports, facilitate timely patient management and prevent complications arising from erroneous treatment.

Generalized Pustular Psoriasis: Review and Consensus of the Psoriasis Group of t

Generalized pustular psoriasis (GPP) is an autoinflammatory disease characterized by primarily sterile pustules, with a widespread distribution, and flares that can be associated with life-threatening complications. Spesolimab (Spevigo®) is the only drug approved for treatment and prevention of GPP flares, and there are uncertainties that justify the development by the Psoriasis Group (GPs) of the Spanish Academy of Dermatology and Venereology (AEDV) of a Delphi consensus on the diagnosis and treatment of this rare disease. A panel of experts, starting from a literature search in PubMed (since 2014), designed a structured questionnaire with assertions that were evaluated (Likert scale from 1 to 7) by 38 members of the PWG with experience in GPP. Following two rounds, between October 2024 and January 2025, agreement (≥80% of participants) was reached on 50 out of 70 statements, including the definition of GPP outbreak, infection screening, medium- and long-term treatment goals, and criteria for initiation of maintenance treatment. This Delphi consensus is intended to support clinicians in the diagnosis and treatment of patients with PPG in our setting.

Canadian Cardiovascular Society/Canadian Pediatric Cardiology Association Focuse

The 2026 Canadian Cardiovascular Society/Canadian Pediatric Cardiology Association focused guidelines outline 10 key recommendations for pediatric acute heart failure. Key domains address diagnostics (recommending CMR for myocarditis, using natriuretic peptides for prognosis, and prioritizing whole exome sequencing over targeted panels) and therapeutic care (encouraging early diuretics, alternating GDMT, choosing milrinone as the preferred inotrope, avoiding routine pulmonary artery catheters, promoting timely VAD implantation, prioritizing temporary MCS over VA-ECMO, and advocating for early left heart decompression under VA-ECMO support).

Quality measures in the design, conduct, and reporting of endoscopic research.

This guideline from the ASGE proposes 9 quality measures designed to improve the design, conduct, and reporting of endoscopic research [1]. Developed by a joint task force via group consensus and systematic literature searches [2], it establishes a framework covering sample size calculation, patient selection, outcome definitions, data integrity, blinding, trial oversight, equity, and conflict disclosures [1, 2, 6, 8].

[A strategy for the diagnosis of thyroid function].

The characteristics of thyroid function tests are analysed. The author stress the importance of the right strategy for investigating thyroid function in the view of expenses, labor and time consuming tests. The guidelines of American Thyroid Association for use of laboratory tests are presented. Finally there is published another investigating protocol, which can be applied for our domestic situations.

The genesis of the ACNM 1971 Statement on Abortion.

In 1971, the Board of Directors of the American College of Nurse-Midwives approved a statement that prohibited certified nurse-midwives (CNMs) from performing abortions. In 1990, the statement was superseded by a second "Statement on Abortion," which essentially reworded the 1971 statement with no substantive change. In 1991, 20 years after the first statement was adopted, a resolution was approved at the Annual Meeting recommending that the Board of Directors rescind the statement, thereby allowing individual CNMs to utilize the guidelines for the incorporation of new procedures into nurse-midwifery practice if she/he decides to provide abortions. This article describes the historical basis for the initial 1971 statement in the hope that an understanding of that history will assist nurse-midwives as they reconsider the statement. In 1970 the New State Abortion Reform Bill was passed. At the time it was the most liberal abortion law in the US. Its passage would result in a massive increase in the number of abortions performed every year in the state of New York. The number increased from around 1000 to 97,881. Since there was much discussion about who was going to perform these extra abortions, the Board of Directors of the American College of Nurse-Midwives (ACNM) passed a statement that prohibited certified nurse-midwives (CNMs) from performing abortions. This justification for this decision was not based on religious or moral arguments. Instead, it was argued that abortion was a surgical procedure outside the expertise of CNMs and should only be performed by licensed physicians. It has been speculated that part of the motivation for the decision was a fear that CNMs would be drafted in large numbers to perform abortions. It has also been speculated that the decision was influenced by controversy created by a CNM who was already performing abortions. A study was conducted that involved asking CNMs who were active at the time, what their remembrances were of the events leading up to the statement. 21 people were interviewed and anonymity was assured. The ACNM has changed very much in the last 20 years. Back then the members were a homogeneous group trying to establish themselves as legitimate health care providers. Today, the membership is much more diverse with CNMs having very different opinions about what CNMs should and should not do and what their goals should be. In 1990 a 2nd statement on abortion was issued which was essentially the same as the 1st. Then in 1991 a resolution was approved at the Annual Meeting recommending that the Board of Directors rescind the statement. Thus, CNMs can now decide for themselves what procedures they can perform.

[Status of preventive examinations against uterine cervix cancer in Denmark].

In 1986, The Danish National Board of Health published guidelines for cervical cancer screening. These guidelines recommend organized screening with personal invitations every three years to women in the age group 23-59 years, and in the years to come also invitations to women aged 60-74 years. Five years have now elapsed since publication of these guidelines, and we have therefore studied the present organization of cervical cancer screening in Danish counties. Organized screening programmes are now, medio 1991, running in 11 out of the 16 "counties" (this includes the municipalities of Copenhagen and Frederiksberg). One county follows the national guidelines entirely. Six counties follow these guidelines in general, but they do not invite women over the age of 60 years. In all, 45% of women aged 25-74 years are at present invited for cervical cancer screening in Denmark. Two counties have decided to start organized screening programmes in 1992.

Guidelines for health physics program content: baccalaureate level.

Guidelines are suggested for baccalaureate health physics program content based on the schema used in a prior publication. The Guidelines assume a program with a primary emphasis on generalized health physics and presuppose an institutional breadth coursework requirement. Methods of strengthening areas of current general weakness are proposed, and one version of a coursework model is presented. Comments to the author and the Manpower and Professional Education Committee of the Health Physics Society are welcomed.

Recommendations for the conduct of acute inhalation limit tests. Prepared by The

This paper reviews the scientific issues related to exposure concentrations and particle sizes used in acute inhalation limit tests. The current United States Environmental Protection Agency (USEPA) recommended exposure concentration for such tests is 5 mg/liter; while this level is very high, it is often achievable. On the other hand, its toxicological relevance is questionable. The USEPA recommendation that 25% of the particle distribution be less than 1 micron is a more difficult issue to address. Physical laws for aerosol particle generation and behavior limit the minimum size of particles in an exposure atmosphere at a concentration of 5 mg/liter. Particle size also influences deposition site in the respiratory tract. Since damage to any region of the respiratory tract can produce lethality, and it is not possible to predict, a priori, the most responsive region of the tract or the most harmful particle size of an untested agent, acute limit testing should employ particles in a size range that deposits throughout the entire rodent respiratory tract. Particles between 1 and 4 microns mass median aerodynamic diameter (MMAD) are well suited for such studies. It is, therefore, recommended that the limit test concentration should be the highest concentration (up to 5 mg/liter) that can be achieved while still maintaining a particle size distribution having an MMAD between 1 and 4 microns.

American College of Chest Physicians/Society of Critical Care Medicine Consensus

To define the terms "sepsis" and "organ failure" in a precise manner. Review of the medical literature and the use of expert testimony at a consensus conference. American College of Chest Physicians (ACCP) headquarters in Northbrook, IL. Leadership members of ACCP/Society of Critical Care Medicine (SCCM). An ACCP/SCCM Consensus Conference was held in August of 1991 with the goal of agreeing on a set of definitions that could be applied to patients with sepsis and its sequelae. New definitions were offered for some terms, while others were discarded. Broad definitions of sepsis and the systemic inflammatory response syndrome were proposed, along with detailed physiologic variables by which a patient could be categorized. Definitions for severe sepsis, septic shock, hypotension, and multiple organ dysfunction syndrome were also offered. The use of severity scoring methods were recommended when dealing with septic patients as an adjunctive tool to assess mortality. Appropriate methods and applications for the use and testing of new therapies were recommended. The use of these terms and techniques should assist clinicians and researchers who deal with sepsis and its sequelae.

Revised guidelines on ethical and legal considerations in anonymous unlinked HIV

A guide to direct measures of patient satisfaction in clinical practice. Health

Guidelines on undergraduate curriculum in the UK. Education Committees of Arthri

Symptomatic locomotor abnormalities are common in medical in-patients, form a significant part of a general practitioner's workload, and are the single most important factor influencing disability in later life. That any qualifying doctor should have basic competencies with respect to the locomotor system thus seems appropriate. A survey of medical schools undertaken jointly by the Arthritis and Rheumatism Council (ARC) and British Society for Rheumatology (BSR) in 1990, however, suggests that the locomotor system still has a relatively low priority in undergraduate medical training. In 1990 therefore, the Education Committees of ARC and BSR established a joint working party to define guidelines on an undergraduate curriculum for rheumatology. These guidelines were discussed and developed at a Workshop in Oxford, and circulated to the Deans and Chairmen of Curriculum Committees at all UK Medical Schools in October 1991. It is hoped these guidelines will encourage inclusion of basic rheumatological competencies within the 'core' curriculum for all medical undergraduates.

Practical guidelines for preparing and administering amphotericin B.

Current practices used in the preparation and administration of amphotericin B are evaluated, and updated guidelines are presented. Intravenous admixtures of amphotericin B 0.25 and 1.4 mg/mL in 5% dextrose injection have an expiration date of 35 days and 36 hours, respectively. Since commercial formulations of amphotericin B lack a bacteriostatic agent, admixtures should be stored at 4-8 degrees C. Protection from fluorescent light is unnecessary. Admixtures may be prepared in polyolefin, glass, or polyvinyl chloride intravenous containers; certain evacuated intravenous containers contain buffers that can cause precipitation of amphotericin B. The addition of a buffering agent to the intravenous admixture is unnecessary when the initial pH of the 5% dextrose injection exceeds 4.2. The usual daily maintenance dose of amphotericin B is 0.5-1 mg/kg i.v. The manufacturer recommends beginning intravenous therapy with a 1-mg test dose. The initiation of therapy with incrementally increased doses may be detrimental if it delays the delivery of a therapeutic dose. Amphotericin B can be infused over one to two hours (less than or equal to 50 mg/hr) in patients with adequate renal function. Bladder instillation of amphotericin B 50 mg in 1 L of sterile water has been used to treat fungal cystitis. Ancillary medications administered to treat infusion-related adverse events should be used as prophylaxis in patients with a history of hypersensitivity or unacceptable reactions and as needed for relief of symptoms. Sodium supplementation should be implemented cautiously, on a patient-specific basis.(ABSTRACT TRUNCATED AT 250 WORDS)

Hospital pharmacy compliance with JCAHO standards and ASHP guidelines for report

The extent to which institutional pharmacies comply with the accreditation standards of the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and the ASHP guidelines for reporting adverse drug reactions (ADRs) was evaluated. A survey was mailed to directors of pharmacy at 444 randomly selected hospitals to collect information on their institutions' ADR programs; the survey addressed each point in the JCAHO accreditation standards and the ASHP guidelines. The 176 usable responses indicated that 89.8% of the institutions met all three of the JCAHO standards and 98.9% met at least two of them; 28.4% of the institutions complied with all 11 of the ASHP guidelines, and 89.2% complied with at least eight of them. Approximately 97% of the institutions had policies for ADR reporting. Respondents reported an average of 70.5 ADRs per hospital during 1989, of which 6.8 per hospital were reported to the FDA. More than 95% of all respondents indicated that they most frequently identified ADRs through voluntary reporting by health-care professionals. Respondents indicated methods and individuals responsible for reporting ADRs, notifying the physician and the FDA, and assessing severity and causality. Sixty-seven percent of the respondents indicated that they did not have a formal ADR committee for monitoring and evaluating ADRs. Almost 90% of the surveyed hospitals complied with all of the JCAHO standards for ADR reporting programs and at least 8 of the 11 ASHP guidelines for ADR monitoring and reporting.

Evaluation and treatment of later manifestations of HIV infection.

An increasing number of primary care physicians will be called on to care for patients with AIDS as the epidemic of HIV infection progresses in the United States. In this article, the more common conditions responsible for significant morbidity and mortality in patients with AIDS have been discussed. It should be apparent that many of these conditions are treatable, either palliatively or with curative intent. Primary care physicians who are familiar with the diagnostic evaluation and therapy of these diseases will therefore be well equipped to provide vital medical care to severely immunocompromised patients with HIV infection.

Initial clinical assessment and management of HIV infection.

Management of HIV infection by the primary care physician can be easily integrated into the usual practice setting. The physician who understands the epidemiology of HIV disease, stays current with basic therapeutic concepts, and knows the patient and his or her living environment is in the best position to help the HIV-infected individual have a constructive and fulfilling life. When the primary care physician has a network of appropriate specialists for consultation and has appropriately integrated office and community-based nonmedical professionals into patient care, the health care team is complete.

Violence against women. Relevance for medical practitioners. Council on Scientif

Evidence collected over the last 20 years indicates that physical and sexual violence against women is an enormous problem. Much of this violence is perpetrated by women's intimate partners or in relationships that would presumably carry some protective aura (eg, father-daughter, boyfriend-girlfriend). This violence carries with it both short- and long-term sequelae for women and affects both their physical and psychological well-being. The high prevalence of violence against women brings them into regular contact with physicians; at least one in five women seen in emergency departments has symptoms relating to abuse. However, physicians frequently treat the injuries only symptomatically or fail to recognize the injuries as abuse. Even when recognized, physicians are often without resources to address the needs of abused women. This report documents the extent of violence against women and suggests path that the physician community might take to address the needs of victims.

Interpersonal communication: a review of eye contact.

Because healthcare takes place in the context of an interpersonal relationship, it is important for the healthcare worker to be cognizant of eye contact and the implications eye contact may have on the delivery of patient care. The healthcare worker should consider a variety of factors in evaluating the patient's eye contact including cultural background, emotional state, personality characteristics, and gender. Each patient should be personally assessed and appropriate healthcare strategies planned that meet individual needs. Interpersonal approaches need to be modified on an ongoing basis as the patient provides feedback during the healthcare worker-patient interaction.

A nursing guide for patient care after percutaneous cardiopulmonary support.

Information is presented about a relatively new procedure being used in the critical care area. The percutaneous insertion technique for the initiation of cardiopulmonary bypass support (PCPS) has given new hope for patients who are considered high risk for elective coronary angioplasty and to those who suffer cardiopulmonary arrest in the cardiac catheterization laboratory or critical care unit. The initiation process of cardiopulmonary bypass support and the criteria for elective cases are reviewed and two case studies follow. Specific attention is given to the immediate postprocedural phase, where nursing responsibilities and prioritization of patient care are addressed. A nursing care guide is included.

Measurement of final container residual moisture in freeze-dried biological prod

The Center for Biologics Evaluation and Research has changed its regulations pertaining to residual moisture in freeze-dried biological products as published in Title 21 of the Code of Federal Regulations for Food and Drugs. The new regulation requires that each lot of dried product be tested for residual moisture and meet and not exceed established limits as specified by an approved method on file in the product license application. The gravimetric or loss-on-drying method is no longer listed as the required method; the 1.0% moisture limit is no longer specifically stated in the regulation. These revisions were made to bring the regulation into line with changes in residual moisture testing methods and the results obtained when new testing methods were applied to the determination of residual moisture. This is illustrated with data for Measles Virus Vaccine Live and Haemophilus b Polysaccharide Vaccine using final container residual moisture test results obtained by the gravimetric, coulometric Karl Fischer, thermogravimetric and thermogravimetric/mass spectrometric methods. Guidelines for the determination of residual moisture in dried biological products have been issued to describe residual moisture test methods and procedures used to set product residual moisture limits. For most products levels of residual moisture should be low, usually from less than 1.0% to 3.0%, so that the viability, immunologic potency and therefore the stability of the product is not compromised over time.

Guidelines for continuous infusion medications in the neonatal intensive care un

To present practical guidelines in tabular form for dosage, calculation, preparation, and monitoring of common medications administered by continuous infusion to neonatal intensive care patients. Review articles and clinical trials were identified through a computer literature search with subsequent bibliography scanning. Articles selected for review were considered important contributions. Data from human studies and review articles published in the English language were evaluated. In emergency situations, physicians and other healthcare providers caring for critically ill newborns often perform rapid calculations to determine the dosage and rate of continuous intravenous medication infusions. Because of the crisis situation, there is the potential for calculation errors. We compiled a concise table designed to provide a standardized method for the administration of emergency medications to neonatal intensive care patients. This table must be used in conjunction with clinical judgment and each medication infusion rate must be adjusted to the patient's clinical response and individual parameters. These guidelines help to minimize the volume of fluid needed for medication administration and facilitate the calculation, preparation, and timely administration of these medications, thus preventing errors that might occur in an emergency situation.

The development of standards and guidelines for cardiopulmonary resuscitation an

There have been four major conferences since 1966 which have produced standards and guidelines for cardiopulmonary resuscitation and emergency cardiac care. These events and publications have served as the principal source and direction for the American Heart Association to develop training programmes for the treatment of sudden cardiac death. The process of standard setting and programme implementation has been very successful in stimulating lay public, health care professional and paraprofessional interest in cardiopulmonary resuscitation techniques. The results of the national campaign may result in as many as 100,000 to 200,000 lives saved per year and successful resuscitation rates from out of hospital sudden death via the chain of survival concept reaching 30% in the United States.

Trauma care systems quality improvement guidelines. American College of Emergenc

While facility QI has been an important tool in the improvement of the care of the trauma patient, it is essential that system QI also be pursued within each trauma care system. These suggested system QI indicators will provide system medical directors and managers with a valuable tool to facilitate the implementation or improvement of the system QI program. Such a program will allow systems to review their overall function, including management, prehospital, and rehabilitative phases. Through this methodology, both individual providers and the overall trauma system can identify deficiencies and institute appropriate modifications to optimize care of the trauma patient.

Anesthesia for severe liver dysfunction.

By using these guidelines, we have safely anesthetized high-risk liver patients with minimal complications. By understanding the consequences of the underlying disease, prudent selection of agents that use alternate methods of excretion, careful perioperative support and management, and close observation during the postoperative period, the liver disease patient may be safely anesthetized with minimal complications.

Advantages and guidelines for using epidural drugs for analgesia.

The administration of drugs by the epidural route is a safe and effective method for providing analgesia before, during, and after a surgical procedure. Local anesthetics administered by this route block nociceptive input as well as providing excellent muscle relaxation for surgery. The use of local anesthetics may be associated with short-term motor dysfunction and hypotension as a result of sympathetic blockade. Morphine given by the epidural route also provides effective analgesia and has the advantages of giving more prolonged analgesia with no effect on either motor or sympathetic pathways.

Advantages and guidelines for using opioid agonist-antagonist analgesics.

The opioid agonist-antagonists are not controlled substances requiring strict record keeping and security because of their low abuse potential. They are effective analgesics in their own right and can be used to antagonize opioid agonist-induced depression while retaining a degree of analgesia. Respiratory depression is less than that induced by opioid agonists, but degree of analgesia is somewhat limited also owing to the ceiling effect.

Advantages and guidelines for using halothane.

Halothane is a frequently used agent. Its cost is inexpensive. Halothane is a safe and effective anesthetic agent if used properly. Proper usage includes adjusting the concentration administered to produce adequate anesthesia for the procedure without excess depression of cardiac, respiratory, and neurologic function. Proper monitoring of the patient indicates the adjustments needed in concentration or needed medications or procedures to increase safe usage. Potent tranquilizers, sedatives, and analgesics used as preanesthetics during halothane anesthesia or the early postanesthetic period may produce profound changes in anesthetic concentrations required or physiologic responses to the combined medications.

Advantages and guidelines for using opioid agonists for induction of anesthesia.

Opioids have a central role in the anesthetic management of small animals, as premedicants, as part of a balanced anesthetic technique, or for the provision of postoperative analgesia. These drugs are safe to use, provide excellent analgesia, and are easily reversible. They cause minimal cardiovascular depression and induce no deleterious renal or hepatic changes. These agents, combined with a sedative, generally provide an ideal anesthetic state.

Advantages and guidelines for using ketamine for induction of anesthesia.

Ketamine in combination with a sedative or tranquilizer is a relatively safe and effective drug for intravenous induction of anesthesia in dogs and cats. If properly dosed, the combination can be used to induce anesthesia with minimal adverse cardiovascular effects, and it is a reasonable method for induction of anesthesia in patients with cardiac disease. If dosage is kept low, the rate of recovery is acceptable, and some of the drugs commonly used in the regimen with ketamine are reversible with appropriate antagonists.

Advantages and guidelines for using ultrashort barbiturates for induction of ane

Despite the introduction of a number of new injectable agents, ultrashort barbiturates continue to be popular. Some of the reasons include rapid, smooth onset of action; predictable hypnotic effects; relatively rapid, smooth recovery; and inexpensiveness. Ultrashort barbiturates also possess some pharmacodynamic properties that make them ideal agents for use in patients with certain diseases or undergoing certain procedures. These include patients with raised intracranial pressure, patients with a history of seizures, patients with corneal lacerations or glaucoma, patients for examination of vocal cord and arytenoid cartilage function, patients with hyperthyroidism, and patients thought to be susceptible to malignant hyperthermia.

Palliative care 2000--home care.

In summary, although I have reservations about the feasibility and cost-effectiveness of regional palliative care centres as described in the report, my recommendations strongly concur with those of the Expert Panel on Palliative Care. With reference to home care, I would like to reiterate the following major points: There must be a major shift of resources into home care and the establishment of "in-the-home projects" within palliative care units. The control of suffering--palliative care--must be a full and equal partner in cancer care. The specialized aspect of home care will benefit from the direct network of a regional medical advisory committee, a quick-response and consultant team, and the integrated coordination system that a regional model offers.

Primary health care in an unsettled area of northern Thailand.

The implementation of primary health care by nurses in poor and geographically isolated areas of the world is a complex and difficult task. When the area is also unsettled and insecure the task becomes increasingly formidable. Under these conditions primary health care is bound by not only the allocation of resources and restricted mobility but also the instability of changing government policies that influence all parameters of life. Mounting evidence has demonstrated that self-determination--derived from community-based socio-economic development--is a prerequisite to the initiation of a successful health care system. In turn, socioeconomic development is possible only when people are secure from expulsion from their land and the country. In addition, they must also be protected against outside coercion and violence that undermines community stability. The following is a report on health care problems related to the socioeconomic instability of an unsettled area that has global implications for nurses in similar areas worldwide.

Acute pain management: operative or medical procedures and trauma, Part 2. Agenc

Summary recommendations 1-5 and 7 should be implemented in every hospital where operations are performed on inpatients. The Acute Pain Management Guideline Panel recommends that any hospital in which abdominal or thoracic operations are routinely performed offer patients postoperative regional anesthetic, epidural or intrathecal opioids, PCA infusions, and other interventions requiring a similar level of expertise, under the supervision of an acute pain service as described in summary recommendation 6. For pain management to be effective, each hospital must designate who or which department will be responsible for all of the required activities. There are a number of alternative approaches to preventing or relieving postoperative pain, many of which can give good results if attentively applied. The following elements, however, apply to most cases and might serve as a focus for assessing the results of these guidelines: 1. Promise patients attentive analgesic care. Patients should be informed before surgery, orally and in printed format, that effective pain relief is an important part of their treatment, that talking about unrelieved pain is essential, and that health professionals will respond quickly to their reports of pain. It should be made clear to patients and families, however, that the total absence of any postoperative discomfort is normally not a realistic or even a desirable goal. 2. Chart and display assessment of pain and relief. A simple assessment of pain intensity and pain relief should be recorded on the bedside vital sign chart or a similar record that encourages easy, regular review by members of the health care team and is incorporated in the patient's permanent record. The intensity of pain should be assessed and documented at regular intervals (depending on the severity of pain) and with each new report of pain. The degree of pain relief should be determined after each pain management intervention, once a sufficient time has elapsed for the treatment to reach peak effect. A simple, valid measure of intensity and relief should be selected by each clinical unit. For children, age-appropriate measures should be used. 3. Define pain and relief levels to trigger a review. Each institution should identify pain intensity and pain relief levels that will elicit a review of the current pain therapy, documentation of the proposed modifications in treatment, and subsequent review of its efficacy. This process of treatment review and follow-up should include participation by physicians and nurses involved in the patient's care.(ABSTRACT TRUNCATED AT 400 WORDS)

[Unstable spinal injuries. Guidelines for treatment].

An injury of the spine may include an injury of the neural structures in the spinal canal. This factor must always be kept in mind during care of a trauma patient until a neurologic injury has been excluded, or the spine stabilized. The classification of spine injuries and evaluation of stability are based on clinical and radiological examinations of the patient. In grade 1 unstable injuries, deformity of the spine may increase if the injury is not stabilized. In grade 2 unstable injuries, a neural involvement may occur if the injury is not stabilized. All injuries with neural involvement are by definition unstable injuries grade 3. Stabilization is indicated for all unstable injuries. In unstable injuries grade 2 and 3, a well-developed method is transpedicular osteofixation with an internal fixator which allows reduction and neutralization of the deforming forces, combined with a transpedicular bone graft to the fractured vertebra. This provides stability and allows early mobilization without immobilizing more segments than involved in the unstable area.

Guidelines for cardiac monitoring of children during and after anthracycline the

The anthracycline antibiotics, daunorubicin, doxorubicin, and the newer derivatives, are important components of many antineoplastic chemotherapeutic regimens. Their usefulness is limited by their cardiotoxicity. Sequential monitoring of cardiac function of patients undergoing chemotherapy allows identification of subclinical cardiotoxicity. In many patients monitoring can thus guide the modification of the chemotherapy to minimize cumulative cardiotoxicity, reducing acute and long-term clinical and subclinical sequelae. Such monitoring also aids in the comparison of cardiotoxicity produced by different drugs and different methods and schedules of drug administration. The considerable variability of monitoring regimens between institutions and in the literature has detracted from its usefulness. The Cardiology Committee of the Childrens Cancer Study Group has, therefore, reviewed the field and has formulated recommendations for standardized noninvasive monitoring of children during and immediately after chemotherapy and for the modification of the chemotherapy where indicated.

A new look at measles.

Since the measles vaccine was licensed in the United States in 1963, the number of measles cases has declined by 98%. Nevertheless, measles has not been eliminated as had been hoped, and, in fact, has started to increase in incidence. The increase in the number of cases has been accompanied by a change in measles epidemiology; the highest attack rate now occurs in preschool-age children and in older school-age and college students. The latter is the basis for the adoption of a two-dose measles immunization schedule by the ACIP and AAP. In preschool-age children, however, the problem is more disturbing and reflects low rates of immunization, particularly among inner-city populations. A major public health effort must be directed to achieve and maintain high vaccination rates if measles elimination is to be accomplished. Otherwise, measles outbreaks, with their accompanying morbidity and mortality, will continue to occur.

Effectiveness of a gentamicin dosing protocol based on postconceptional age: com

To evaluate the effectiveness of a gentamicin dosing protocol based on postconceptional age in producing therapeutic serum concentrations and to compare the protocol with commonly used gentamicin dosing guidelines. During the initial three months of this study infants were dosed according to physician discretion (group I). In the subsequent three-month period patients were dosed according to a postconceptional age dosing schedule (group II). Infants were enrolled after being admitted to the Newborn Intensive Care Unit at the University of Miami/Jackson Memorial Medical Center. Infants less than 37 weeks gestational age with normal renal function, not receiving indomethacin, and requiring gentamicin treatment were enrolled. Fifty-nine infants were enrolled into group I (median weight 1300 g [range 720-3300]), postconceptional age 29 weeks [26-37]); and 68 infants were enrolled into group II (weight 970 g [530-3000], postconceptional age 29 weeks [24-36]). Patients in group II were dosed according to the following protocol: postconceptional age less than 30 weeks, 3.0 mg/kg q24h, and postconceptional age 30-37 weeks, 2.5 mg/kg q18h. Peak and trough serum gentamicin concentrations were obtained in all study patients. Pharmacokinetic parameters were calculated from measured serum concentrations. Using the calculated pharmacokinetic data, peak and trough serum concentrations were simulated for five published neonatal dosing guidelines and the proposed postconceptional age protocol. The number of therapeutic serum gentamicin concentrations resulting from the dosing guidelines studied were compared. Measured trough concentrations differed significantly between the two groups with 35 percent of patients in group I and 90 percent of patients in group II having trough values less than 2 mg/L (p less than 0.001). There was no significant difference in measured peak concentrations between groups. Simulated trough concentrations were significantly different when postconceptional age dosing was compared with commonly used protocols (p less than 0.0001) with the highest percentage of concentrations less than 2 mg/L (89 percent) resulting from the proposed postconceptional age guidelines. These data suggest that the proposed postconceptional age protocol is reproducible and reliable in achieving therapeutic gentamicin serum concentrations in neonates.

Consensus guidelines: preconception counseling, management, and care of the preg

All women with epilepsy who are of childbearing age should be advised (preferably before conception) that the incidence of malformations in infants of mothers with epilepsy who are treated with antiepileptic drugs (AEDs) is two or three times that of infants of mothers without epilepsy. In addition, children of mothers with epilepsy, treated or untreated with AEDs, tend to have slightly more minor anomalies than do children of fathers with epilepsy or control subjects. We do not know which of the four major AEDs (phenytoin, carbamazepine, valproate, and phenobarbital) is the most teratogenic. If AED treatment cannot be avoided, the first-choice drug for the seizure type and epilepsy syndrome should be used as monotherapy at the lowest effective dose. Diet prior to conception and during organogenesis should contain adequate amounts of folate. Prenatal diagnosis of possible birth defects should be offered, and patients should be followed closely during pregnancy, labor, and puerperium. Despite the small but significant risks, more than 90% of women with epilepsy who receive AEDs during pregnancy will deliver normal children free of birth defects.

Towards an ethic of service provision. Royal College of Physicians.

Guidelines and a proposed audit protocol for the initial management of an acute

Guidelines and audit measures for the specialist supervision of patients with rh

Guidelines on palliative care.

Infection prevention guidelines for cardiac catheterization laboratories. Societ

The following guidelines for prevention of catheterization laboratory infections are based on standard precautions for infection prevention in surgical wounds. Specific recommendations for patient preparation include proper methods for hair removal, skin cleaning and draping, antibiotic prophylaxis, wound irrigation and dressing, and sheath removal. Sterile precautions should be more vigorous for cutdown procedures compared to percutaneous. Caps, masks, gowns, and gloves help to protect both the patient and operator. Handwashing is the most important procedure for preventing infections. Maintenance of the catheterization laboratory environment includes appropriate cleaning, limitation of traffic, and maintenance of adequate ventilation. Proper catheterization technique and appropriate use of sterile equipment will decrease the wound infection rate. Protection of personnel may be accomplished by proper gowning and gloving, disposal of contaminated equipment, and care of puncture wounds and lacerations. All personnel should receive vaccination for hepatitis B.

Interim guidelines for the treatment of uncomplicated gonococcal infection.

Toward the rational management of herpes infection in pregnant women and their n

[Patients with functional symptoms--what should be done?].

Unspecific complaints are one of the major reasons why doctors are consulted. The management of these patients is difficult and has been little explored. Most doctors confine their efforts to ruling out organic causes for the patient's symptoms, a policy which often results in frustration for both doctor and patient. The following guidelines for better management have proven useful in clinical practice: (1) Psychosocial history: Psychosocial data should be obtained from the start, not only when no organic reason is found to explain the symptoms. (2) Specific questions: What alleviates symptoms, what makes them worse? In the case of vague answers ("stress") it is preferable to check before giving hasty advice. (3) Disclosing the diagnosis: It is necessary to convey the idea that the symptoms are real. Phrases such as "It's nothing" or "It's all in your head" should be avoided. (4) Lay theory: The patient's view of the reasons for his symptoms should be explored. (5) Agreement on working hypotheses: Knowing the patient's lay theory, the doctor can shape his suggestions to match the patient's convictions. (6) Therapeutic goals: Establishment of a climate of trust between patient and doctor can avoid "doctor shopping" and protect the patient from unnecessary diagnostic procedures. (7) Psychotherapeutic techniques: A supportive approach and relaxation techniques of limited duration (5-10 consultations) afford long-term benefit.

Prenatal weight gain advice: an examination of the recent prenatal weight gain r

The Institute of Medicine (IOM) recently published new guidelines for maternal weight gain during pregnancy. Using data collected at Moffitt Hospital, University of California at San Francisco, we examined the associations between maternal weight gain outside the recommendations of the IOM and three pregnancy outcomes (small for gestational age [SGA] infants, large for gestational age [LGA] infants, and cesarean delivery). These analyses were repeated using population-specific weight gain ranges derived from a subgroup of women in this cohort with healthy pregnancy outcomes. The purpose of the study was to compare the national guidelines of the IOM with hospital standards. Both the recommendations of the IOM and the hospital ranges were associated with fewer SGA infants, LGA infants, and cesarean deliveries. The overall associations were similar for the population-derived and national ranges. Although the IOM ranges should be examined in other populations and with other birth outcomes, our results validated their recommendations. Maternal weight gain within the IOM recommendations reduced the risk of the outcomes studied; furthermore, these ranges performed as well as those derived from the target population.

Conflicts of interest. Physician ownership of medical facilities. Council on Eth

In this report, the Council on Ethical and Judicial Affairs revisits the question of referral of patients to medical facilities in which physicians have financial interests ("self-referral"). The Council issued safeguards in 1986 to prevent abuses of self-referral and most recently updated the guidelines in 1989. Recent studies, however, have suggested that problems with self-referral persist; these problems undermine the commitment of physicians to professionalism. The Council has concluded that, in general, physicians should not refer patients to a health care facility outside their office practice at which they do not directly provide care or services when they have an investment interest in the facility. Physicians may invest in and refer to an outside facility if there is a demonstrated need in the community for the facility and alternative financing is not available.

Dietary recommendations for people with diabetes: an update for the 1990s. Nutri

The broad principles of the 1982 British Diabetic Association dietary recommendations remain valid. For the overweight, reduction in energy intake remains the most important aim. Carbohydrate should make up about 50-55% of the dietary energy intake, the majority of this coming from complex sources, preferably foods naturally high in dietary fibre or hydrolysis resistant starch. Up to 25 g of added sucrose may be allowed, provided it is part of a diet low in fat and high in fibre, and that it substitutes for an isocaloric amount of fat or high glycaemic index food or other nutritive sweeteners. Some high-carbohydrate diets have been shown to worsen blood glucose control and serum lipid abnormalities. Some previous recommendations for fibre intake have proved unrealistically high and of limited value. A modest increase to 30 g day-1, concentrating on soluble fibre, is recommended. Reduction of fat intake to 30-35% of energy intake remains an important goal which should help to reduce the incidence of cardiovascular disease in people with diabetes and aid weight loss. Of this only 10% of total energy should be saturated fat, 10% polyunsaturated fat, and 10-15% may be mono-unsaturated fat. The latter has been shown to provide a useful alternative energy source which may have beneficial effects on blood glucose control and serum lipids. Cholesterol intake should not exceed 300 mg day-1. Protein should comprise about 10-15% of energy intake. Reduction in intake of protein and associated nutrients may help to slow down progression of nephropathy. Limitation of salt intake to 6 g day-1 is recommended. Reduction in fat intake may be relatively more important in Type 2 diabetic patients, whereas limitation in protein intake may be more important in Type 1 diabetes.

Policies, guidelines, and recommendations for MR imaging safety and patient mana

The following are policies, guidelines, and recommendations from the Safety Committee of the Society for Magnetic Resonance Imaging (SMRI) concerning various issues related to magnetic resonance (MR) imaging safety and patient management. These policies, guidelines, and recommendations were developed to provide standardized and consistent information for use by health practitioners involved in clinical MR imaging.

[Standards in quality assurance in nursing].

The purpose of this article is to describe what kind of nursing standards have been written in Finland. The quality assurance process of nursing includes setting of nursing standards. They express the desired quality level of nursing. They would also guide the practice of nursing. The analysed nursing standards were collected from five university hospitals, 15 central hospitals and nine health centers. The standards were collected with the questionnaire studying the present situation of quality assurance of nursing in Finland. The total number of analysed nursing standards was 190. According to the results the standards were mostly set to evaluate and characterize the quality of nursing of the certain patient group (e.g. new born child, dying patient, cancer patient in chemotherapy) and to evaluate the realization of nursing principles. Safety and individuality of nursing and independence and autonomy of patient were the most often appeared nursing principles in the analysed standards. The standards were written in passive and the level of quality was the ideal optimum. The nursing standards were expressed often abstractively and in such a form that the measurement and evaluation of reached level of the standard is a very difficult task.

Standards of perioperative nursing. Clinical practice/professional performance.

The standards of perioperative nursing provide a mechanism to delineate the responsibilities of registered nurses engaged in practice in the perioperative setting. The standards of perioperative nursing and recommended practices serve as the basis for quality monitoring and evaluation systems; data bases; regulatory systems; the development and evaluation of nursing service delivery systems and organizational structures; certification activities; job descriptions and performance appraisals; agency policies, procedures, and protocols; and educational offerings.

Long-term fluctuation of the visual field in glaucoma.

We examined 756 automated threshold visual fields of 167 eyes of patients with glaucoma to determine the magnitude of the long-term fluctuation at individual test locations. Eyes were grouped into clinically stable or nonstable groups according to predefined clinical criteria. At individual test locations with initial sensitivities of 25 to 30 dB in clinically stable eyes, the 5th to 95th percentile value for subsequent measurements was +/- 4 dB. For initial sensitivities of 20 dB, this 90% range was +/- 6 dB, and for sensitivities 15 dB or less, the 90% range of subsequent values spanned sensitivities from almost zero to normal values. Long-term fluctuation correlated with short-term fluctuation (r = .363, P less than .0005), but not with age or intraocular pressure. There was no correlation of long-term fluctuation with eccentricity after correcting for the decreased sensitivity associated with greater eccentricity. Long-term fluctuation was greater in the nonstable group than in the stable group (P less than .0005). These data provide limits for fluctuation in stable patients with glaucoma, which will help guide clinical decisions about visual field progression.

[Treatment of non-insulin dependent diabetes (type 2 diabetes mellitus)].

Type 2 diabetes mellitus is characterized by impaired insulin release and sensitivity, elevated blood sugar and unfavourable changes in blood lipids. Insulin resistance and adverse blood lipids are also seen in the state of essential hypertension (the metabolic syndrome). Patients should learn to measure their own blood sugar. Treatment usually begins with regulation of the diet for 3-6 months. If this treatment fails, the next step is to give oral antidiabetic agents. Insulin treatment is required 1) when blood sugar is excessively high; 2) when oral agents fail; and 3) in case of increased need of insulin due to intercurrent disease. Antihypertensive treatment should not have adverse metabolic effects in patients with type 2 diabetes.

Management of depression in patients with advanced cancer.

To formulate guidelines on the assessment, diagnosis and treatment of depressive symptoms in patients with advanced cancer, based on a review of the literature and clinical experience. Articles from a range of international, peer-reviewed journals, texts by acknowledged experts and diagnostic manuals. The works cited focused either on the prevalence and diagnosis of depression in patients with cancer or related conditions or on the management or treatment of depressive symptoms arising in these patients. Information was summarised and integrated into the management strategy. There is an increased frequency of depressive-type symptoms in patients with cancer. In assessing the mood of these patients the physician needs to consider a wide range of factors. Diagnostic issues regarding depression in the medically ill are still being clarified. A good rapport with the patient and an understanding of the emotional conflicts engendered in the individual are important for good management. Active psychotherapeutic strategies include cognitive therapy techniques, management of self-defeating patterns of thought and low morale, and psychosocial group treatments. The side effects of antidepressants in the medically ill may preclude their use, although cyclic antidepressants in a lower dose range have been found to be useful. There is a need for more research into the diagnosis of depression in the medically ill and the use of antidepressants and counselling techniques in patients with cancer. The adequate management of depressed mood which occurs commonly in the patient with advanced cancer requires an integration of biological, psychological and social perspectives. Orchestrating the use of supportive measures, counselling and antidepressants requires both clinical skill and humanity.

Toward integrated medical resource policies for Canada: 3. Analytic framework fo

Current status of topical tretinoin in the treatment of photoaged skin.

In 1986, an open study was published which showed that tretinoin 0.05% applied topically to actinically damaged skin could partially reverse the clinical and histological signs of photoaging. These results stimulated other investigators to examine the effects of tretinoin on photodamaged, prematurely aged skin. Double-blind controlled studies in the United States and Europe have confirmed the original claims. Side effects have been limited to a variable irritant reaction (dryness, tightness, erythema) that subsides as the treated skin accommodates. Physicians must counsel patients to have realistic expectations; tretinoin is not a substitute for plastic surgery. Tretinoin is the centrepiece of a treatment programme which includes regular use of sunscreens and moisturisers along with avoidance of harmful behaviours, such as smoking, use of abrasives, and excessive washing.

[Emergency blood supplies and their use in elective surgery. Background and dire

It cannot be anticipated that the increasing requirements for blood and blood components will be covered by proportionate expansion in gross supply. Blood component therapy, i.e. specific substitution of clinically important deficiencies, is recommended. In addition to being clinically rational, this principle of treatment provides enhanced utilization of resources, product quality and transfusion safety. By reviewing the literature, an unjustified excess of blood ordering and crossmatching was demonstrated in elective surgery. Practical application of Type and Screen (T&S) and thorough revision of preoperative blood ordering policies are safe and resource-saving measures, and guidelines such as these are proposed.

[Antibiotic prevention of bacterial endocarditis].

Bacterial endocarditis is a serious condition with high lethality. The authors review the etiology of the disease and conditions and procedures associated with increased risk, and give recommendations on choice and dosage of effective antibiotics. Most cases of endocarditis are caused by gram-positive cocci of the genera Streptococcus, Enterococcus or Staphylococcus. The number of cases caused by staphylococci has increased in recent decades. Risk of acquiring endocarditis is higher, for example, in patients with prosthetic cardiac valves and in patients with a previous history of endocarditis. Interventions associated with increased risk include various procedures in the mouth, throat and upper airways, since this is where the bacteria most often causing endocarditis are to be found. A single oral dose of amoxycillin is recommended for standard prophylaxis, and ampicillin in combination with an aminoglycoside for parenteral use. In cases of penicillin allergy, a single oral dose of clindamycin is recommended in patients at risk of bacteriemia from the respiratory tract, with trimetoprim as an alternative for genito-urinary and gastrointestinal procedures. Vancomycin or vancomycin plus aminoglycoside is recommended as a parenteral regimen in cases of penicillin allergy.

Guidelines for the diagnosis of occupational asthma. Subcommittee on 'Occupation

The 'Guidelines for the diagnosis of Occupational Asthma' have been written by the Subcommittee on Occupational Allergy of the European Academy of Allergology and Clinical Immunology to give common diagnostic criteria in the evaluation of individual patients with suspected occupational asthma. The suggested diagnostic procedure includes five steps. 1. History suggestive of occupational asthma. 2. Confirmation of bronchial asthma, with demonstration of reversibility of bronchial obstruction, of non-specific bronchial hyperreactivity and of increased diurnal variability of peak expiratory flow rates (PEFR). 3. Confirmation of work-related bronchoconstriction with serial measurements of PEFR and of non-specific bronchial reactivity. 4. Confirmation of sensitization to occupational agents with skin tests and/or in vitro tests to detect specific immunoglobulins. 5. Confirmation of causal role of occupational agent with specific bronchial challenges. Requirements, advantages and limitations are discussed for each of the suggested techniques.

Criteria for the diagnosis of ischemic vascular dementia proposed by the State o

Accurate diagnosis of vascular dementia is important for the recognition of underlying pathophysiology and the institution of appropriate therapy. It is also important for the determination of the incidence and prevalence of not only vascular dementia but also Alzheimer's disease (AD), since differentiating between these two entities is often problematic. The State of California Alzheimer's Disease Diagnostic and Treatment Centers (ADDTC) herein propose criteria for the diagnosis of ischemic vascular dementia (IVD). These criteria broaden the conceptualization of vascular dementia, include the results of neuroimaging studies, emphasize the importance of neuropathologic confirmation, refine nosology, and identify areas that require further research. Parallel use of the proposed definitions of "possible" and "mixed" categories in the diagnosis of both AD and IVD would ensure compatibility between the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for AD and the ADDTC criteria for IVD. Uniform classification of subtypes of IVD will improve the generalizability of individual studies and aid in multicenter collaborations.

Guidelines in electrodiagnostic medicine. American Association of Electrodiagnos

The American Association of Electrodiagnostic Medicine (AAEM) is committed to the development of sound and clinically relevant guidelines through review of literature, expert opinion and consensus. In 1979, with the assistance of its Professional Practice Committee and association leaders, the association published its initial guidelines, Guidelines in Electrodiagnostic Medicine, covering the practice of electrodiagnostic medicine. The committee is charged with ongoing revision of the document, as needed, and the current version includes standards of practice in clinical electromyography, risks in electrodiagnostic medicine, basic equipment requirements, and the role of paramedical support. In 1988, Educational Guidelines for Electrodiagnostic Training Programs (Appendix A) was prepared by the AAEM Training Program Committee and added to aid training program directors in establishing new training programs or in reviewing the current status of the educational aspects of existing programs. In 1986, the AAEM charged its Quality Assurance Committee with the responsibility for the development of guidelines pertinent to electrodiagnostic medical consultations. The impetus for the charge was the requests received from members of the AAEM and other interested parties for educational material on indications for and conduct of electrodiagnostic medical consultations. As a result of the committee's efforts, Suggested Guidelines for Electrodiagnostic Medical Consultations (Appendix D), was published in 1989 and additional sections added subsequently. The current document includes (1) general indications for an electrodiagnostic medical consultation for patients with suspected myopathies, neuromuscular junction disorders, polyneuropathies, mononeuropathies, plexopathies, radiculopathies, neuronopathies and central nervous system disorders, (2) specific indications for patients with suspected lumbosacral or cervical radiculopathies, (3) general principles of electrodiagnostic studies, including techniques and diagnostic categories, and (4) an overview of electrodiagnostic studies for patients with suspected carpal tunnel syndrome, idiopathic polyneuritis, amyotrophic lateral sclerosis and myasthenia gravis.

Impact of voluntary vs enforced compliance of third-generation cephalosporin use

The purpose of this study was to assess and compare the impact of voluntary compliance and enforced compliance with institutional guidelines for initiating third-generation cephalosporin therapy. An audit of third-generation cephalosporin use during a 6-month period shortly after ceftriaxone and ceftazidime were added to the hospital formulary already containing cefotaxime was performed. During this period, compliance to institutional guidelines for initiating therapy was voluntary. A follow-up audit during a similar 6-month period was performed to assess compliance with institutional guidelines shortly after an enforcement policy was placed in effect. The results of these two audits were compared to assess usage patterns of these cephalosporins, compliance rates with institutional guidelines for initiating therapy, use of susceptibility testing to guide therapy, effect of use of these drugs on susceptibility patterns within the hospital, and third-generation cephalosporin costs during periods when institutional policy was unenforced and enforced. Only 24.2% of 66 courses of third-generation cephalosporins were initiated in compliance with institutional guidelines during the initial audit period. Susceptibility testing revealed an organism susceptible to a first-generation cephalosporin in 13 courses but in only six instances was a switch to the more narrow-spectrum antibiotic performed. At the time routine susceptibility testing to ceftazidime and ceftriaxone was instituted, 92% of Enterobacter cloacae were sensitive to ceftriaxone and 89% of Pseudomonas aeruginosa were sensitive to ceftazidime. Fifteen months later, when voluntary compliance to institutional policy was terminated, 70% of E cloacae were sensitive to ceftriaxone and 73% of P aeruginosa were sensitive to ceftazidime. During the last 6 months of this period, pharmacy expenditures totaled $50,000. The second audit revealed 85.4% of 48 courses of treatment complied with guidelines for initiating therapy. Since enforcement was instituted, sensitivity of E cloacae to ceftriaxone has risen to 88% and sensitivity of P aeruginosa to ceftazidime has increased to 80%. Pharmacy expenditures decreased to $23,000.

United States Preventive Services Task Force recommendations on breast cancer sc

The US Preventive Services Task Force (USPSTF) was established in 1984 by the US Department of Health and Human Services to develop recommendations on clinical preventive services based on evidence from published clinical research. Guidelines issued in 1989 addressed 169 preventive services in 60 topic areas. This article reviews the USPSTF recommendations on breast cancer screening, which call for annual clinical breast examinations after 40 years of age, mammography every 1 to 2 years beginning at 50 years of age, and early screening of women at increased risk for breast cancer. The USPSTF methodology for evaluating the quality of evidence and the scientific rationale for its recommendations are reviewed.

Guidelines for controlling meningococcal disease.

Standards, guidelines and clinical policies. Health Services Research Group.

Coronary angioplasty for unstable angina.

Coronary angioplasty is an effective treatment for subgroups of patients with unstable angina. The procedure has a high initial success rate but there is an increased risk of major complications resulting from a higher incidence of acute closure presumably related to additional injury of the underlying plaque with augmented platelet and clotting activity, and ensuing spasm. Newer agents that inhibit platelet aggregation or thrombin may provide a safer use of coronary angioplasty in patients with unstable angina. Coronary angioplasty is indicated if a stenosis, technically suitable for dilation, is found to be responsible for the unstable state. The decision in favor of coronary angioplasty in patients with single-vessel disease is easy to make. Patients with left main stem disease or severe multivessel disease should primarily be scheduled for bypass surgery. In the presence of other multivessel disease, uncertainty remains. However, in selected patients with multivessel disease, one might prefer dilation of the ischemia-related vessel "the culprit vessel" only, rather than total revascularization by multiple dilatations or bypass surgery, since this can be performed faster and thus shorten the hospital stay. Thrombolytic treatment in the management of patients with unstable angina may be indicated in patients with pre-existing intracoronary thrombi or when procedural acute closure occurs associated with intracoronary thrombus formation.

A guide to temporary pacing.

Guidelines for disclosing HIV-antibody test results to clients.

Because of new preventive therapies, HIV-antibody testing of asymptomatic individuals now has clear clinical benefits. Consequently, greater numbers of individuals are expected to seek testing. This article, based on the authors' experiences with disclosing HIV-antibody test results to a high-risk group of men, makes recommendations for how best to present HIV-antibody results. Disclosing HIV-antibody results provides an educational opportunity as well as a psychological challenge for clinicians. Some unusual client reactions are detailed in the case studies.

[Intervention for suicide attempters in general hospitals].

The quality of care delivered to persons who attempt suicide and are transfered to a general hospital is a topic of debate in many Dutch hospitals. A working committee of the Medical Scientific Council of the National Organization for Quality Assurance in Hospitals (CBO) issued a report with practical guidelines on the skills and organizational context needed for proper diagnosis and treatment of this group of patients. In this article the main elements of the report are described: a definition of attempted suicide, judging of persons attempting suicide, minimal requirements for first-aid, organizational issues, development of protocols (covering somatic as well as psychiatric care) and the role of mental-health care professionals.

Human immunodeficiency virus testing experience and hepatitis B vaccination and

To assess the previous human immunodeficiency virus (HIV) testing experience and the hepatitis B (HB) vaccination and testing status of healthcare workers potentially involved in invasive surgical procedures. Anonymous questionnaire survey. Tertiary care and community-teaching medical center and affiliated healthcare facilities in Greenville County, South Carolina. Physicians (including residents in training), dentists, nurses and surgical technicians working in the operating room and labor/delivery areas. Of 506 responding physicians and dentists (65% of the sample), 60% previously had had a test for HIV, and 72% had received HB vaccine. Testing had occurred most often because of a requirement by an insurance company or because of blood donation. Eighty percent of tested respondents had their most recent test within 2 years of the time of the survey (August 1991). Of 145 responding nurses and surgical technicians (73% of the sample), 26% had had a test for HIV and 77% had received HB vaccine. The majority of surgeons and dentists in Greenville County, South Carolina, already have been tested for HIV for a variety of reasons and thus are aware of their HIV infection status, at least as of the time of the most recent test. The majority of local healthcare workers who are potentially involved with invasive surgical procedures have received HB vaccine. Programs developed in response to recent US Public Health Service guidelines should take HIV testing of healthcare workers for any reason into consideration and should emphasize HB vaccination and testing for vaccine-induced HB immunity.

Building quality of life assessment into cancer treatment studies.

Quality of life is increasingly recognized as an important outcome of cancer treatment. However, quality of life research poses considerable problems in design and implementation. This article provides guidelines for the preparation of phase III therapeutic protocols that include quality of life assessment. The guidelines emphasize the distinct requirements of quality of life research and provide specific recommendations for the questions that need to be addressed in protocol development.

Guide to interpreting and evaluating the pharmacoepidemiologic literature.

The purpose of this guide is to provide review criteria for the pharmacoepidemiologic literature. Case-control and cohort studies are the major methodologies used in pharmacoepidemiologic analysis. Evaluation criteria for case-control and cohort studies address proper sample-frame definition, compatibility of cases and controls, drug-exposure validations, unintended-effect ascertainment procedures, and considerations for confounding. Moreover, interpretation of the statistics used in reporting cohort and case-control studies is provided. Further review criteria are given for meta-analysis, an approach to integrating the pharmacoepidemiologic literature.

Dental care for the pediatric cardiac patient.

The treatment plan for the pediatric cardiac patient must include the following: 1. A complete medical history that will elicit adequate information with respect to the patient's possible heart condition. 2. Consultation with the family physician, pediatrician and/or cardiologist to learn the specific nature of the defect, specific past history, the child's ability to tolerate stress and anxiety, current medication and any specific recommendations for patient management. 3. Antibiotic prophylaxis, in an effort to prevent endocarditis, for all dental procedures that are likely to result in gingival bleeding, including routine professional cleaning. Application of chlorhexidine may be used as an adjunct to antibiotic prophylaxis, particularly in patients who are at high risk and/or with poor dental hygiene. 4. Prompt and vigorous treatment of all infections, with extraction to be considered as the preferred treatment for endodontically involved primary teeth. 5. A frank and open discussion with the parents and patient, detailing the importance of strict oral hygiene and regular dental care for both the oral and general health of the patient. As important as appropriate antibiotic prophylaxis is to the patient's continued health, it must be stated in summation that the dentist's efforts to foster optimal oral health are perhaps even more significant. Dental manipulation is in no way essential to the genesis of bacteremia, and it must be assumed that frequent showers of organisms are the rule in individuals who neglect their mouths. Perhaps the dentist performs the greatest service for this group when he or she succeeds in significantly modifying their oral hygiene behavior, thus preventing inadvertent septic "suicide".

Ergonomic standards, guidelines, and strategies for prevention of back injury.

Now is the time for ergonomics to be taken seriously. OSHA and other regulatory agencies are concentrating on ergonomic issues, directing greater efforts in developing ergonomic guidelines and standards. Employers are being required to develop multifaceted programs to include prevention, education, and treatment. Ergonomics will become one of the direct responsibilities of ergonomists, safety professionals, and health care providers. Progress in preventing musculoskeletal injuries and illness will depend on the cooperation and availability of trained safety and health professionals who are knowledgeable about ergonomics and the extent of musculoskeletal problems in the workplace. These trained personnel must be able to educate workers and employers about risk factors and to assist them in implementing effective control procedures for prevention. Those responsible for the program will need to keep up-to-date with current engineering and medical trends in the field and be required to keep abreast of the latest legislation and regulations. The challenge is great but the rewards are even greater. Employers implementing ergonomic programs have not only reduced recordable injuries, saved hundreds of thousands of dollars in labor and materials, and reduced turnover, but have experienced increases in production and quality. The reduction in human suffering alone is reason enough to develop an effective proactive ergonomic management program.

Periodic health examination, 1992 update: 3. HIV antibody screening. Canadian Ta

Guidelines for surgical residents' working hours. Intent vs reality.

To comply with voluntary California medical school guidelines, our general surgery residency program reduced in-house call to 1 in 4 nights, and scheduled a 72-hour work-week. We assessed the effectiveness of these changes by prospectively surveying the actual working hours of surgical house staff through completion of a daily schedule for 1 month. Actual in-hospital hours averaged 98 per week, significantly exceeding the scheduled hours, and were greater for interns (100 hours) and junior residents (97 hours) than for chief residents (95 hours). Twenty hours (22%) of nonconference waking hours were spent on so-called scut work. Significant reduction of intern work hours could be accomplished by expansion of ancillary care, allowing more time for direct patient care. The effect on senior house staff hours would be less dramatic but might be sufficient to bring hours into compliance with proposed limits.

Recommendations for the use of folic acid to reduce the number of cases of spina

Spina bifida and anencephaly are common and serious birth defects. Available evidence indicates that 0.4 mg (400 micrograms) per day of folic acid, one of the B vitamins, will reduce the number of cases of neural tube defects (NTDs). In order to reduce the frequency of NTDs and their resulting disability, the United States Public Health Service recommends that: All women of childbearing age in the United States who are capable of becoming pregnant should consume 0.4 mg of folic acid per day for the purpose of reducing their risk of having a pregnancy affected with spina bifida or other NTDs. Because the effects of higher intakes are not well known but include complicating the diagnosis of vitamin B12 deficiency, care should be taken to keep total folate consumption at less than 1 mg per day, except under the supervision of a physician. Women who have had a prior NTD-affected pregnancy are at high risk of having a subsequent affected pregnancy. When these women are planning to become pregnant, they should consult their physicians for advice.

Euthanasia by decapitation: evidence that this technique produces prompt, painle

Rapid euthanasia of laboratory rodents without the use of anesthesia is a necessary research technique whenever there is the likelihood of anesthesia or stress interfering with the chemistry of the tissues under investigation. Decapitation has long been the procedure of choice under such circumstances. Recently, however, the American Veterinary Medical Association (AVMA) panel on euthanasia recommended that decapitation be avoided on the grounds that the decapitated head may be conscious and suffering for as much as 15 seconds. The panel further recommended that if decapitation was scientifically necessary, the decapitated head be immediately immersed in liquid nitrogen. These AVMA guidelines now enjoy regulatory status; the recommendation that decapitation be avoided has thus caused considerable difficulty for all research requiring rapid, anesthesia-free collection of tissues. The scientific validity of these recommendations is consequently a matter of great practical as well as theoretical importance. The decision to discourage decapitation appears to have been based on a single literature report claiming that the EEG of the decapitated head revealed conscious suffering for more than 10 seconds (Mikeska and Klemm 1976). This review carefully examines the scientific literature on this subject. It is concluded that the report by Mikeska and Klemm of EEG activation in the decapitated head is correct, but that this phenomenon is also seen when the decapitated head is under deep anesthesia, and in normal brains under ether anesthesia or during REM sleep. Hence these findings do not demonstrate either consciousness or the perception of pain.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical practice guidelines for treatment of diabetes mellitus. Expert Committe

Statement on influenza vaccination for the 1992-93 season.

Guidelines for management of idiopathic thrombocytopenic purpura. The British Pa

Report of working group of the British Association of Perinatal Medicine and Neo

Screening for retinopathy of prematurity.

To die with dignity.

This paper examines the conundrum facing an individual with a terminal disease who wishes to end his or her life in a manner that maintains a minimum of dignity. The State's interest versus the individual's right to live or die is examined in its various aspects. The interference by the State supplanting the Church as the authority that interprets the boundaries between life and death, with the individual losing his voice as well as his body to the impersonality of maintaining a life not worth living, is studied, as well as the implicit dangers when the freedom to decide when and who should die is measured against the present international economic situation. The need to listen to the language of the dying as well as to their need for a 'closure' is approached with a view to future study.

Basics and recommendations for brain SPECT. Task Group "Neurology" of the Europe

In this article guidelines for single-photon emission computerized tomography (SPECT) of the brain are presented by the Task Group "Neurology" of the European Association of Nuclear Medicine (EANM). Under separate headings are discussed: the pathophysiologic principles of various brain diseases, pharmacokinetics and pharmacodynamics of various radiopharmaceuticals, physical principles of SPECT imaging, computerized data processing, clinical protocols and the evaluation of SPECT results.

Clinicians' quick reference guide to acute pain management in infants, children,

The management of pain is an important part of a health professional's role. The challenge for clinicians is to balance pain control with concern for patient safety and side effects of pain treatments. This is the second of two articles presenting the clinical highlights of the Agency for Health Care Policy and Research's Panel to develop clinical practice guidelines for pain management. This article presents the clinical highlights related to the assessment and management of pain in infants and children.

Clinicians' quick reference guide to postoperative pain management in adults. Pa

The management of pain is an important part of a health professional's role. The challenge for clinicians is to balance pain control with concern for patient safety and side effects of pain treatments. This is the first of two articles that summarize the highlights of the Agency for Health Care Policy and Research's Panel to develop clinical practice guidelines for the management of pain. This first article includes a summary of the methods used to develop the guidelines and the clinical highlights of pain assessment and management in adults.

Principles of ethics and code of professional conduct with official advisory opi

The ethical statements which have historically been subscribed to by the dental profession have had the benefit of the patient as their primary goal. Recognition of this goal, and of the education and training of a dentist, has resulted in society affording to the profession the privilege and obligation of self-government. The Association calls upon members of the profession to be caring and fair in their contact with patients. Although the structure of society may change, the overriding obligation of the dentist will always remain the duty to provide quality care in a competent and timely manner. All members must protect and preserve the high standards of oral health care provided to the public by the profession. They must strive to improve the care delivered--through education, training, research and, most of all, adherence to a stringent code of ethics, structured to meet the needs of the patient.

Guidelines on the management of tuberculosis and HIV infection in the United Kin

Cigarette smoking and small irregular opacities.

Annotated guidelines on gifts to physicians from industry. American Medical Asso

We have responded on an individual basis to many requests for interpretations of grey areas in the opinion on gifts from industry since its release in December 1990, and many physicians and companies asked for a detailed list of these interpretations. While the council agrees with the concerns several individuals have expressed about additional rules, it authorized this revised list of questions and answers which replaces the earlier draft. It also established three main principles for future implementation: 1. The key principles of the guidelines should be carefully observed by physicians, and the AMA will remain active in attempting to secure compliance by its members. The overriding rule is that individual physicians should not accept substantial gifts from industry, even if the gift has an educational or patient benefit. It is important that the profession set clear and enforceable standards in this regard. 2. Professional associations should make their own interpretations of the appropriateness of gifts to them from industry. Under appropriate conditions, associations of physicians may, of course, receive gifts from industry. 3. Neither the council nor its staff will attempt to regulate minor issues or minute details of compliance. For many situations there are no yes or no answers. Some black letter rules are necessary so that conduct that should be changed is changed. In addition, they aid companies which want to comply with the spirit as well as the letter of the guidelines without putting themselves at a competitive disadvantage. The six points of the Opinion cover most situations and compliance to date has been good.(ABSTRACT TRUNCATED AT 250 WORDS)

Practice guidelines for nutrition care by dietetics practitioners for outpatient

Practice guidelines for nutrition care by dietetics practitioners for outpatient

In summary, nutrition practice guidelines for dietitians who provide outpatient care for persons with NIDDM provide a roadmap for nutrition care that allows for consistency in individualized care. A field test that compares care according to practice guidelines with usual or basic care can provide evidence, based on medical, education/behavior, and cost outcomes, that practice guidelines are not only reasonable and realistic but also effective.

Liver biopsy versus ultrasound in methotrexate-treated psoriasis: a decision ana

Before starting methotrexate therapy for cases of recalcitrant psoriasis, a liver biopsy has been usual in order to exclude cirrhosis and moderate or severe fibrosis, which are contraindications for methotrexate treatment. As mortality and morbidity of liver biopsy are not negligible, and as this invasive procedure is unpleasant for the patient and urges clinical admission, we evaluated the possibility of ruling out severe liver pathology by means of ultrasonography, which we compared to liver biopsy. We made this comparison by means of a decision tree. The advantages of this analysis are the clear definition of the decision problem and its alternatives, and the possibility of calculating the risk of each alternative, thus being able to choose the best diagnostic method. In this study, the results of various research groups are discussed, in which liver biopsy and liver ultrasound were compared. In our decision tree we used some of these results and other assumptions, based on comparable studies. We varied the biopsy mortality and the sensitivity of ultrasound to show the change in the risk of each alternative. Our analysis shows that the differences of expected values between the liver biopsy branch and the ultrasonography branch are relatively small. Therefore, we advise each center, which has at its disposal a specialist in liver ultrasonography, to re-evaluate its guidelines with regard to the detection of severe liver pathology before starting methotrexate for the treatment of psoriasis.

Guidelines for thermometry in clinical hyperthermia.

High quality thermometry is needed in hyperthermia to (1) ensure safe delivery of adequate therapy and (2) provide the quantitative information needed to develop prognostic parameters which will aid research into planning and dosimetry. Currently, only invasive thermometry which is subject to several sources of artifact is available to address these requirements. This paper summarizes techniques which have been developed to reduce these artifacts to acceptable levels, outlines quality assurance requirements ensuring good practice in the use of invasive thermometry during clinical treatments and ends with a brief discussion of thermometry requirements for control of various hyperthermia systems.

Convulsions in children.

Classification, management and prevention of seizures in children are summarized for clinicians in Papua New Guinea. Seizures are classified as febrile with or without underlying brain pathology, and afebrile, including neonatal fits, infantile spasms, myoclonic jerks, akinetic seizures, tonic clonic fits, petit mal, benign focal, and psychomotor seizures. In all cases the first step is to secure the airway, then do a fingerstick and treat hypoglycemia, and finally stop the fit if it is prolonged with paraldehyde, diazepam, phenobarbitone or phenytoin. A cause for the seizure should be sought: physical exam, especially tympanic membranes and throat, blood slide for malaria, lumbar puncture for signs of meningitis, blood culture, serum calcium, and other chemistries. Some empirical treatments to use for negative findings include: dextrose, calcium gluconate, magnesium SO4, pyridoxine, quinine and Fansidar. Hyperthermia in a febrile child can be reversed with cool sponging. The author recommends prescribing phenobarbitone to prevent subsequent simple febrile seizures if the child has 3 or more, then slowly withdrawing the drug if the child is seizure free for a year. Drug therapy for the various other types of seizures available in Papua New Guinea include sodium valproate by special order, and phenobarbitone, phenytoin, carbamazepine, nitrazepam, ethosuximide, and prednisolone. A table is provided to help select the drug for each seizure type, e.g. ethosuximide for petit mal, prednisolone for infantile spasms, and carbamazepine for various types of focal and psychomotor seizures.

[Expert witness in cases of rape].

The decision to try a rape case in court may depend on the medico-legal evidence documented by a doctor. Generally, doctors have little knowledge of expectations and requirements in court regarding testimony and expert opinion. In 1990, the Norwegian Directorate of Health recommended that victims of rape and violence all over the country--independent of police notification--be offered a medical and a medico-legal examination and follow-up. The Oslo Emergency Hospital has practised this health service for six years. The article describes the Oslo routine as a basis for doctors with little or no knowledge of the subject. Rape trauma, a variant of post-traumatic stress disturbance, manifests over time as physical, psychological and social reactions which influence the patient's health. The doctor must therefore follow the patient over time in order to apply this diagnosis. Rape trauma may be unknown to the court; a reason why the doctor should inform the prosecutor if it is decided that the case is to be tried in court. In order to document rape trauma as evidence the doctor must be called as an expert medical witness and not as an ordinary witness.

[Contact tracing in genital chlamydia infections].

Only one in five general practitioners in Norway initiates notification of partner(s) after diagnosing a case of genital chlamydial infection. In order to increase the use of this efficient case-finding method we review the aims of notifying partners and the judicial, ethical and economical aspects of the method. We describe both provider-referral and patient-referral methods. The first approach is chosen when the index patient wants to remain anonymous. General practitioners are advised not to give the index patient medication for the contacts. Instead, the contacts should be examined and informed by qualified personnel. Notification of partner will be a cornerstone in the struggle to control the current epidemic of genital chlamydial infection in Norway.

[Use of the R-concept in a medical department].

Do-not-resuscitate orders issued in a medical department were studied by retrospective evaluation of 195 consecutive deaths in the department in 1991. No attempt at resuscitation was recorded in 171 patients. In these cases, do-not-resuscitate orders were documented in 67 only. For more than half of the orders, no reason was given in the medical record, and partial orders not to resuscitate were found in five patients only, none of whom were resuscitated. No difference was found in use of do-not-resuscitate orders between intensive-care units and regular wards, between patients above and patients below 80 years of age, or between patients with and patients without cancer. We suggest extended use of do-not-resuscitate orders in our department, and better documentation of the orders. Written guidelines have been established for this purpose.

Proposed guidelines for diagnosis of chromosome mosaicism in amniocytes based on

Currently, accepted protocol which has been developed at the Prenatal Diagnosis Laboratory of New York City (PDL) requires that when a chromosome abnormality is found in one or more cells in one flask, another 20-40 cells must be examined from one or two additional flasks. Chromosome mosaicism is diagnosed only when an identical abnormality is detected in cells from two or more flasks. In a recent PDL series of 12,000 cases studied according to this protocol, we diagnosed 801 cases (6.68 per cent) of single-cell pseudomosaicism (SCPM), 126 cases (1.05 per cent) of multiple-cell pseudomosaicism (MCPM), and 24 cases (0.2 per cent) of true mosaicism. Pseudomosaicism (PM) involving a structural abnormality was a frequent finding (2/3 of SCPM and 3/5 of MCPM), with an unbalanced structural abnormality in 55 per cent of SCPM and 24 per cent of MCPM. We also reviewed all true mosaic cases (a total of 50) diagnosed in the first 22,000 PDL cases. Of these 50 cases, 23 were sex chromosome mosaics and 27 had autosomal mosaicism; 48 cases had numerical abnormalities and two had structural abnormalities. Twenty-five cases of mosaicism were diagnosed in the first 20 cells from two flasks, i.e., without additional work-up, whereas the other 25 cases required extensive work-up to establish a diagnosis (12 needed additional cell counts from the initial two culture flasks; 13 required harvesting a third flask for cell analysis). Our data plus review of other available data led us to conclude that rigorous efforts to diagnose true mosaicism have little impact in many instances, and therefore are not cost-effective. On the basis of all available data, a work-up for potential mosaicism involving a sex chromosome aneuploidy or structural abnormality should have less priority than a work-up for a common viable autosomal trisomy. We recommend revised guidelines for dealing with (1) a numerical versus a structural abnormality and (2) an autosomal versus a sex chromosome numerical aneuploidy. Emphasis should be placed on autosomes known to be associated with phenotypic abnormalities. These new guidelines, which cover both flask and in situ methods, should result in more effective prenatal cytogenetic diagnosis and reduced patient anxiety.

[A guide to prevent infectious disease due to MRSA].

Now in Japan, infectious diseases due to MRSA is an important problem to solve and it has a growing social interest. It is clearly associated with hospital infections. So most important thing for us is to prevent and treat properly hospital infections. As a result of thorough investigations in a hospital for aged persons and a general hospital, we developed some guidelines to prevent MRSA infections. It is necessary to have a prevention committee in the hospital which will do the followings: Reveal the present condition of hospital infections by thorough investigations, make appropriate choice of antibiotics, good care of patients having infectious diseases due to MRSA, good care of carriers, better use of disinfectants, and education of medical staffs.

The epidemiology and treatment of depression when it coexists with somatoform di

This article reviews the relationship between depressive disorders and somatoform disorders, somatization, and pain. These disorders and symptoms are clinically interrelated, yet the nature of the interrelation is not well understood. This review of the literature from 1975 through mid-year 1990 addresses the epidemiology and treatment of these conditions and/or symptoms when they occur together. When robust criteria are used to determine which publications are included, only 14 are available that address depressive disorders, somatoform disorders, and somatization. Similarly, there are only 13 that address depressive disorders and pain. Taken together, these studies indicate that 1) in somatization disorder patients, there is a high prevalence of depression; 2) in patients with major depression, there are substantial levels of hypochondriacal and somatizing symptoms; 3) that depression in the face of coexisting somatization disorder can be successfully treated; 4) in chronic pain patients, there is a high prevalence of depressive disorders; 5) in patients with major depression, pain is a frequent complaint; 6) and finally, that pain improves with the treatment of depression. What is most striking from this review, however, is the very limited number of studies that address these important problems. This lack of research-based data calls for new aggressive research efforts in this area.

The depressed alcoholic. Clinical features and medical management.

A relationship between depression and alcoholism has long been postulated. A review of prior research studies reveals that though patients with depression do not appear to develop alcoholism to any great extent, recently detoxified alcoholics have a depressive syndrome about 20% of the time. This cannot be accounted for readily from data on family studies or genetic studies, which generally suggest that alcoholism and depression are two independent illnesses, albeit both quite common. Clinically, depressed alcoholics resemble alcoholics more than they resemble depressives. The clinical course of depression when it coexists with alcoholism is generally benign and self-limited, with most patients becoming euthymic over the course of 2-4 weeks without specific antidepressant treatment. In some depressed alcoholics, however, a more chronic depression persists, and may predict a worse outcome for the alcoholism. Treatment of depression in alcoholics should be initially conservative. Tricyclic and other antidepressants should be used with extreme care as they may potentiate toxic effects of alcohol.

Screening laboratory evaluation in psychiatric patients: a review.

Routine laboratory screening of psychiatric patients is a common clinical practice. Several studies have demonstrated the limited utility and higher cost of ambulatory and preadmission screening in the evaluation of general medical patients. The data concerning the use of such screening profiles in psychiatric patients are reviewed. Widespread use of extensive screening batteries, consisting of complete blood cell count (CBC), complete blood chemistry analysis, erythrocyte sedimentation rate (ESR), urinalysis, B12, folate, electroencephalogram (EEG), electrocardiogram (EKG), and chest x-ray film, is not indicated in the majority of psychiatric patients. Such investigations result in many abnormal findings, most of which are clinically insignificant and do not affect patient management and outcome. Most abnormal results can be predicted by information obtained from a careful history, review of systems, and physical examination. Certain populations appear to benefit from more extensive evaluation, including those older than 65 years of age or of low socioeconomic status, state hospital patients, patients with drug and alcohol histories, and patients with evidence of disorientation, self neglect, or organic mental disorders. The few tests that have merit as broader screening tests in asymptomatic patients include serum glucose, blood urea nitrogen (BUN), creatinine, and urinalysis. Patients on psychotropic medications should be monitored for side effects of that particular therapy. Further prospective data are needed to develop cost-efficient, population-specific diagnostic strategies.

Epidemiology of depression in primary care.

Major depressive disorder has been recently found to be associated with high medical utilization and more functional impairment than most chronic medical illnesses. Major depression is a common illness among persons in the community, in ambulatory medical clinics, and in inpatient medical care. Studies have estimated that major depression occurs in 2%-4% of persons in the community, in 5%-10% of primary care patients, and 10%-14% of medical inpatients. In each setting there are two to three times as many persons with depressive symptoms that fall short of major depression criteria. Recent studies have found that in one-third to one-half of patients with major depression, the symptoms persist over a 6-month to one-year period. The majority of longitudinal studies have determined that severity of initial depressive symptoms and the presence of a comorbid medical illness were predictors of persistence of depression.

[Civil aviation and cardiology. Admission rules and follow-up of the technical f

The authors, based in European and American rules, consensus positions of Clinical Aerospace Congresses and their own experience, marked admission and follow-up rules of conduct for TAP Air Portugal aircrew. They stressed the importance of modern technology in arterial pressure ambulatory diagnosis and pointed the necessity of arterial pressure treatment in the other cardiovascular risk factors context. They relief ischemic myocardial disease because it is incompatible with flying safety, even in those submitted to coronary angioplasty or bypass graft surgery. For those with arrhythmias, valvular heart disease, myocarditis, cardiomyopathy and adult life congenital heart disease, we emphasize admission and follow-up rules.

Orthopedic nursing practice guidelines. The NAON Standards Task Force.

The NAON Standards Task Force has revised Orthopaedic Nursing: Process and Outcome Criteria for Selected Nursing Diagnoses published jointly by the American Nurses' Association (ANA) and NAON in 1986. The new document is entitled Orthopaedic Nursing Practice Guidelines. It contains guidelines for the care of orthopaedic patients with 11 selected nursing diagnoses and is an important decision-making tool for orthopaedic nurses. This article contains excerpts from the new guidelines with suggestions for its use.

Guidelines for the assessment and management of chronic obstructive pulmonary di

National Asthma Education Program Expert Panel report: guidelines for the diagno

1. Asthma, a chronic lung disease that affects 10 million Americans, is receiving increased attention as a public health problem due to increased occurrence and number of reported deaths. 2. This article presents an overview of the National Asthma Education Program Expert Panel guidelines, specifically addressing the definition and pathophysiology of asthma, effective management and control of asthma, and special considerations in asthma management. 3. Implications of the Expert Panel guidelines for occupational health nurses are addressed.

FDA requirements for nonclinical testing of contraceptive steroids.

Written guidelines for the preclinical testing of contraceptive steroids have not been revised since 1968 despite the fact that many important changes have been implemented by the FDA's Division of Metabolism and Endocrine Drug Products. This paper describes the new preclinical testing requirements and the rationale for their implementation. The Division of Metabolism and Endocrine Drug Products of the US Food and Drug Administration (FDA) has effected many significant changes since it last revised its written guidelines for preclinical testing of contraceptive steroids in 1968. Yet it did not update the guidelines, which pertain to both male and female contraceptives, until 1992. Type and duration of preclinical studies for Clinical Phase I are single-dose studies in rats and mice using an amount that produces overt toxicity and which is administered through the same route as intended for humans and repeat dose studies in rats and monkeys (up to 200 times the human dose for rats and 50 times the human dose for monkeys) for at least 1 month. The FDA is flexible about the duration of preclinical studies for Phase II as long as the duration is at least as long as the duration of the proposed clinical trial (6-month maximum for rats and 1-year maximum for monkeys). Preclinical trials for Phase II are the same studies as for Phase II as well as genotoxicity tests. For genotoxicity tests, the FDA recommends in vitro mammalian cell gene mutation assay with and without metabolic activation, in vitro chromosome aberration test in mammalian cells with and without metabolic activation, and the mouse micronucleus test for chromosome damage. Preclinical studies for FDA are a 6-month toxicology study in rats, a 12-month toxicology study in monkeys, and a 2-year carcinogenicity study in rats or mice. The FDA can consider other species for toxicology testing. Pharmacology tests, generally done in rodents, determine drug effects on neurological, cardiovascular, and immunological parameters. Researchers should use steady state conditions to study pharmacokinetic parameters including, Tmax, Cmax, T1/2, and area under the curve. Toxicologic tests on contraceptives with estrogen/progestogen combinations should use the ratio to be marketed or, if they have more than 1 ratio, the lowest ratio. FDA remains flexible to any deviations for which there is a sound scientific rationale.

EPA priorities for biologic markers research in environmental health.

The infant home monitoring dilemma. Fetus and Newborn Committee, Canadian Paedia

Ethics in aboriginal research. A model for minorities or for all?

Guidelines for research among Aborigines and Torres Strait Islanders were approved by the National Health and Medical Research Council (NHMRC) in 1991. The recommendations seem more stringent than those previously published by the NHMRC for medical research in general. Several States independently have proposed or promulgated similar guidelines for Aboriginal research. This paper indicates the themes common to such guidelines and how they seek both to redress past faults and to encourage a greater participation and authority by Aboriginal communities when research is conducted among them. It is suggested that the guidelines raise questions about the control of research and the role of consumer groups that are of far-reaching importance to medicine.

Predictive testing for Huntington's disease: protocol of the UK Huntington's Pre

Canadian Society of Clinical Chemists position paper: standardization of selecte

This Canadian Society of Clinical Chemists (CSCC) sponsored position statement addresses the problem of nonuniformity of standardization of polypeptide hormone analyses. First we review the structural diversity of selected polypeptide hormones including growth hormone (GH), prolactin, follitropin (FSH), lutropin (LH), human chorionic gonadotropin (hCG), and thyrotropin (TSH) and the problem that this heterogeneity creates. The history and availability of reference materials for the analyses of these hormones are then summarized. Finally we make a list of recommendations regarding standardization, methods of measurement, and reporting of polypeptide hormone results. Implementation of the recommendations will lead to improvement in inter-laboratory comparability and more useful hormone assays.

Ambulatory ophthalmic surgery and the Health Care Financing Administration's Out

The quality of care rendered in ambulatory ophthalmic surgical centers is subject to the standards outlined in the Health Care Financing Administration's "Outpatient Surgery Generic Quality Screen Guidelines." Ophthalmic Surgery accounts for 28.2% of all ambulatory surgery performed in the United States. Diabetes, respiratory disorders, renal failure, and hypertension are a few of the clinical problems that are handled in a nontraditional fashion in ophthalmic surgery facilities throughout the United States with excellent results and low incidence of complications. Trends in the clinical management of patients in ophthalmic surgical centers are described by data obtained in a survey conducted by the anesthesia and surgical staff of the Parris-Castoro Cataract and Laser Center in Bel Air, MD. The survey addressed the current trends in obtaining history and physicals, electrocardiograms, chest radiographs, and laboratory studies before outpatient ophthalmic surgery.

Evaluation of new anti-infective drugs for the treatment of genital infections d

This guideline addresses clinical trials of new therapies for genital infections due to herpes simplex virus (HSV). Of the two types of virus, HSV-2 is the more common pathogen. Both HSV-1 and HSV-2 become latent in sacral nerve root ganglia and intermittently reactivate. Patients who have frequent recurrences (more than four per year) may be candidates for long-term suppressive therapy. In both first-episode and recurrent genital HSV infections, lesions should be cultured for HSV. Testing for human immunodeficiency virus is encouraged but not required. Serum antibodies to HSV-1 and HSV-2 should be quantitated at enrollment and 3-5 weeks thereafter. Randomized, double-blind, active-control comparative studies are generally recommended. Placebo-controlled trials may be appropriate for recurrent genital herpes or for suppression of recurrences. Final evaluation should generally take place 10-15 days after the completion of therapy.

Special issues in clinical trials of new anti-infective drugs for the treatment

Several special issues arise in relation to clinical trials of therapy for sexually transmitted diseases. These issues include the desirability of including adolescents and both pregnant and nonpregnant women in the trial, the use of unapproved control regimens, problems with antimicrobial susceptibility testing due to inadequate methodology and the need for prompt treatment, the need to assess agents for treatment of syndromes of unknown microbial etiology, toxicity considerations related to the use of single-dose regimens, management of the sexual partners of the participants in the trial, analysis of data despite the high frequency of minor protocol violations, sexual reexposure to infection during the trial, and the potential for loss, alteration, or falsification of data because of the relative simplicity of the usual protocol design and the diagnostic reliance on specimens that are routinely discarded.

Evaluation of new anti-infective drugs for the treatment of infective endocardit

These guidelines describe the design and implementation of clinical trials to assess the safety and efficacy of anti-infective drugs for the treatment of infective endocarditis. Identification and enrollment of patients in clinical trials is based on a modification of traditional criteria. To accrue a sufficient number of patients, only those with streptococcal or staphylococcal endocarditis should be included in studies. Results of treatment with approved drugs allow for projection of expected bacteriologic cure rates and survival rates. Prospective randomized, double-blind studies are recommended. These guidelines are based on the premise that future protocols may include shorter courses of therapy, combinations of drugs, or progression from parenteral to oral therapy. Clinical response is judged as cure, failure, or indeterminate; there is no "improved" category. Microbiologic response is categorized as eradication, persistence, or relapse. When a patient has shown no clinical evidence of active disease for a protracted period, there may be no need to perform a posttreatment blood culture; for such patients, the microbiologic response is termed presumptive eradication. Several months of follow-up may be necessary to detect late relapses.

Evaluation of new anti-infective drugs for the treatment of respiratory tract in

Evaluation of new anti-infective drugs for the treatment of acute pelvic inflamm

Pelvic inflammatory disease (PID) is a syndrome unrelated to pregnancy or surgery and characterized by lower abdominal pain and tenderness, cervical motion tenderness, and adnexal tenderness. Fever, leukocytosis, and the results of laboratory tests are used to support the diagnosis. Participants in clinical trials should be stratified into two groups: those with and those without tubo-ovarian abscess--i.e., those with complicated and those with uncomplicated PID. Diagnostic studies and treatment should be directed at four major groups of pathogens: Neisseria gonorrhoeae, Chlamydia trachomatis, anaerobic bacteria, and facultative bacteria such as Escherichia coli. Women requiring hospitalization should generally be treated as inpatients for at least 4-7 days; outpatient therapy should then be instituted to complete a 14- to 21-day course. Clinical and laboratory evaluations should be conducted daily during hospitalization and both 2-4 days and 2-4 weeks after the completion of therapy.

General guidelines for the clinical evaluation of anti-infective drug products.

This document provides new general guidelines for the design and execution of studies evaluating anti-infective drugs for the prevention or treatment of infectious diseases. The first step in evaluation is the determination of in vitro microbial susceptibility. Next, studies are conducted in animals. Several animal models provide information useful in the prediction of appropriate dosing and activity in humans. If the results of these studies are favorable, staged clinical trials are then conducted. These guidelines reflect changes in the practice of medicine, dealing with topics such as the switch from parenteral to oral drug administration during a course of therapy, treatment in settings other than acute-care hospitals, and the use of alternative comparison drugs for the study of indications or dosing schedules not covered by the product label. Because further changes in practice are anticipated, the present guidelines will need to be updated and revised periodically.

Evaluation of new anti-infective drugs for the treatment of acute pelvic infecti

This set of guidelines deals with evaluation of anti-infective drugs for treatment of acute pelvic infections in hospitalized women. The clinical entities include infectious complications of cesarean section; elective hysterectomy; and septic, incomplete abortion. Conditions including endomyometritis, cuff cellulitis, pelvic cellulitis, parametritis, phlegmon, and pelvic abscesses may arise due to a variety of bacterial species, both aerobic and anaerobic, that comprise the endogenous flora of the lower reproductive tract. Anaerobic bacteria have assumed particular importance, and therapy should be directed against such organisms. The roles of enterococci, chlamydiae, and mycoplasmas remain uncertain. Culture samples must be obtained under conditions assuring minimal vaginal contamination. Before a new drug may be used for treatment of human pelvic infections, considerable information is necessary about its antimicrobial spectrum as well as its safety and efficacy. Placebo-controlled trials are considered unethical. Historical controls may be used, but concurrent active control comparative trials are preferred. Parenteral administration is recommended for at least the initial 4 days of therapy, but orally administered drugs may be evaluated for completion of longer courses. The expected cure rate is approximately 90%. Uncomplicated infections should be treated for at least 4 days; more complicated infections may require prolonged therapy. Although clinical cure is paramount, microbiologic response must also be taken into account. In the final assessment, outcome will be classified as cure, failure, or indeterminate.

General guidelines for clinical bacteriology. Infectious Diseases Society of Ame

This guideline summarizes recommendations for (1) developing cogent procedures for diagnosis and antimicrobial susceptibility testing; (2) developing quality-control parameters for the microbiological components of clinical trials; (3) continually updating U.S. Food and Drug Administration (FDA) guidelines; (4) reviewing microbiological recommendations from other groups, such as Microbiology Subcommittees of the National Committee for Clinical Laboratory Standards; and (5) improving the microbiological aspects of FDA package inserts for antimicrobial drugs. Sensitive and specific methods for isolation and identification of pathogens are essential to the proper conduct of clinical trials. Susceptibility tests should be performed in an accurate and reproducible fashion. Verification of results in a reference laboratory is encouraged to monitor quality control.

Evaluation of new anti-infective drugs for the treatment of intraabdominal infec

These guidelines deal with the evaluation of anti-infective drugs for the treatment of intraabdominal infections. The clinical entities consist of infections arising from any part of the gastrointestinal tract, from the distal esophagus to the colon. These include surgical infections of the bowel, biliary tree, liver, spleen, and pancreas. Virtually all intraabdominal infections are due to multiple microorganisms resident in the gastrointestinal tract; these include aerobes and facultative and obligate anaerobes. Infections are classified as complicated (requiring an operative procedure), uncomplicated (managed medically), and postoperative wound (the operative procedure should be curative, but anti-infective drugs are used to prevent further infection at the site). Clinical criteria are paramount for entry into a study and for evaluation of efficacy. For complicated infections an adequate operation is an important determinant of outcome and needs assessment. Cultures of purulent intraabdominal fluid or abscess material are the only valid microbiologic indicators of infection. The acute physiology and chronic health evaluation score is useful in defining the severity of acute illness. The control regimen should consist of effective, established drugs and surgical procedures for the condition. Duration of therapy for complicated infections is usually 5-14 days; for uncomplicated infections, 3-7 days; and for postoperative wound infection, 2-5 days. Periodic assessment of safety and efficacy must be conducted during therapy. The outcome at final assessment is cure, failure, or indeterminate.

Evaluation of new anti-infective drugs for surgical prophylaxis. Infectious Dise

It has been established by substantial research that antimicrobial prophylaxis for various surgical procedures can reduce the risk of postoperative morbidity and mortality. When the incidence of infectious complications is high, the reduction with prophylaxis is most dramatic. However, even for many "clean" procedures (vascular procedures, total joint replacement), the small reduction in potentially calamitous complications justifies the use of prophylaxis. Many issues of detail remain unanswered: timing and duration of administration of antimicrobial drug; type of drug; use of topical anti-infective agents as ancillary measures; and choices for high-risk individuals and others ordinarily excluded from clinical trials. An approach to the conduct of clinical trials of anti-infective drugs for surgical prophylaxis is provided. Both general guidelines and specific recommendations for total hip replacement, colorectal operations, appendectomy, and transurethral resection of the prostate are included.

Evaluation of new anti-infective drugs for the treatment of disease caused by My

Mycobacterium kansasii is a photochromogenic nontuberculous mycobacterium that usually causes infections of the respiratory tract in humans. Although spontaneous resolution of infection has been reported, most patients require antimycobacterial therapy. A three- or four-drug combination--isoniazid, rifampin, and ethambutol and/or streptomycin--usually is prescribed. For evaluation of a new drug, a randomized, double-blind or evaluator-blinded, active-control comparative study design is recommended. Treatment should continue for 18-24 months, and follow-up evaluations should be conducted every 6 months for 3 years. Microbiological outcome is paramount.

Evaluation of new anti-infective drugs for the treatment and prevention of infec

The bacteria of the Mycobacterium avium complex are ubiquitous; thus it is often difficult to distinguish environmental contamination from colonization or infection. Patients with either pulmonary or disseminated infection may be enrolled in clinical trials. Disseminated disease occurs mostly in patients infected with the human immunodeficiency virus. In general, a randomized, active-control, double-blinded clinical trial is preferred; there should at least be a blinded evaluator. With regard to immunosuppressed populations, new antimycobacterial drugs need to be evaluated not only for the treatment but also for the prevention of disease. For trials of prophylaxis a placebo-controlled design is ethical until a drug is proven effective; then the use of an active-control regimen is appropriate. Since no regimen has been approved by the U.S. Food and Drug Administration for treatment or prevention of disease caused by the M. avium complex, demonstration of the superiority of the study regimen to the control regimen should be the objective of the clinical trial.

Evaluation of new anti-infective drugs for the treatment and prevention of tuber

This guideline addresses the evaluation of new antimycobacterial drugs in the treatment and prevention (secondary prophylaxis) of infection by M. tuberculosis. Patients may be enrolled in clinical trials on the basis of clinical and/or microbiological criteria. A therapeutic regimen will likely include a combination of drugs; a randomized, active-control, comparative clinical trial is recommended. If appropriate samples can be obtained for culture during follow-up without placing the patient at unwarranted risk, the assessment of microbiological outcome is paramount. Prophylaxis will probably require a single drug, and a similar study design is preferred.

Evaluation of new antifungal drugs for the treatment of systemic fungal infectio

These guidelines are applicable to all fungal pathogens that produce systemic infections in humans. Specific examples are provided whenever they might clarify special issues. Systemic fungal infections usually are divided into two broad categories: endemic systemic fungal diseases, which occur classically in healthy hosts, and opportunistic fungal diseases, which occur almost exclusively in patients with impaired host defenses. Both the increasing frequency of disseminated histoplasmosis and coccidioidomycosis in patients with AIDS and the occurrence of candidemia due to vascular-line infections have begun to blur this distinction. The fungi included in these guidelines are Histoplasma capsulatum, Coccidioides immitis, Blastomyces dermatitidis, Candida species, Cryptococcus neoformans, Aspergillus species, and Sporothrix schenckii. Diagnosis of infections caused by these fungi should be based on culture of infected body fluids or tissues whenever possible. Cryptococcal and coccidioidal meningitis are exceptions. Amphotericin B remains the standard comparative agent for most new agents. Further studies of the efficacy of new oral agents used alone or after a hospital course of amphotericin B are needed. The agents currently available are usually inadequate for eradication of fungal infections in patients with AIDS, who may need prolonged treatment. Final assessment for these patients may need to be classified as clinical cure with presumed microbiologic persistence.

Evaluation of new anti-infective drugs for the treatment of gastritis and peptic

Helicobacter pylori is a gram-negative, microaerophilic, spiral bacillus. Infection by this organism is currently believed to be the major cause of type B gastritis. Inflammation and infection may persist for years in the absence of therapeutic intervention. There is currently no approved antimicrobial therapy for gastritis. Clinical investigations have shown that combination regimens including bismuth salts and antimicrobial drugs result in the relief of symptoms, the resolution of histologic evidence of gastritis, the eradication of H. pylori, high rates of ulcer healing, and lower rates of ulcer relapse than have been found with other therapies (antacids and H2 antagonists). A randomized, double-blind, placebo-controlled study design is recommended for evaluation of new therapies. Study participants should have their progress monitored by endoscopy performed at enrollment, at completion of therapy, and 3 months thereafter. Assessment of microbiological outcome is paramount for final evaluation of the patient.

Evaluation of new anti-infective drugs for the treatment of antibiotic-associate

Colitis due to Clostridium difficile is diagnosed in 10%-15% of hospitalized patients who develop diarrhea after treatment with antimicrobial drugs. Diagnosis is based on the concurrence of diarrhea, one or more signs or symptoms of enteric intoxication, and stool from which toxigenic C. difficile is isolated or from which its toxins are identified. Clinical trials evaluating therapy may be placebo controlled (for mild disease) or concurrently controlled with an active drug. A randomized, double-blind study design is preferred. Outcome should be assessed by monitoring of the degree of inflammation of the bowel mucosa, the intensity and severity of diarrhea, the duration of illness, changes in stool form, and the eradication of C. difficile or its toxins from stool. Because C. difficile can be a component of the normal gastrointestinal flora, assessment of clinical outcome is paramount.

Evaluation of new anti-infective drugs for the treatment of chronic carriage of

The chronic carriage of salmonellae is defined as the shedding of a Salmonella species for > or = 1 year, as documented by an initial positive culture of a stool sample obtained at least 1 month after resolution of the acute illness and repeated positive cultures for at least 1 year. Clinical trials of investigational anti-infective drugs for the treatment of the salmonella carrier state may be conducted with a placebo control or an active concurrent control. A crossover design also may be employed for establishing efficacy. Patients should generally receive therapy for at least 6 weeks. Outcome will be assessed only by microbiological criteria. Determination of the interval required for the suppression of salmonellae and follow-up for 6 months after completion of therapy are recommended.

Evaluation of new anti-infective drugs for the treatment of diarrhea caused by E

Entamoeba histolytica causes colonic infection that ranges from asymptomatic carriage to invasive disease with infection of extraintestinal organs, particularly the liver. The disease occurs in both sporadic and epidemic forms. Diagnosis requires visualization of trophozoites or cysts by microscopic examination of stool, colonic scrapings, or biopsy specimens. Patients with either asymptomatic or symptomatic disease may be eligible for clinical trials. A prospective, randomized, double-blind, placebo-controlled study design is recommended for asymptomatic carriers and an active-concurrent-control study design for symptomatic patients. Final outcome should be assessed 48 hours to 7 days after completion of therapy. Assessment of microbiological outcome is paramount.

Evaluation of new anti-infective drugs for the treatment of diarrhea caused by C

Cryptosporidium is a coccidian protozoan that produces symptoms by infesting the small bowel. The illness is characterized by watery stools, anorexia, weight loss, and abdominal pain. Diagnosis is made by visualization of the organisms on microscopic examination of stool. There currently is no approved therapy for this infection. A randomized, double-blind, placebo-controlled study design is recommended. Stratification of patients by age and immune status should be considered. Two stool samples obtained 48 hours to 7 days after completion of therapy should be negative for Cryptosporidium oocysts. Assessment of microbiological outcome is paramount.

Evaluation of new anti-infective drugs for the treatment of diarrhea caused by G

Giardia lamblia is a flagellate protozoan that produces symptoms by infecting the small bowel and biliary tract in the trophozoite form. Diagnosis is currently established by microscopic visualization of the organism in appropriate intestinal contents (stool, small-bowel contents, or biopsy specimen). Adult patients with diarrhea and one or more enteric symptoms may be enrolled in clinical trials of new drugs for the treatment of giardial disease. A randomized, double-blind, active-concurrent-control design is recommended. Post hoc stratification by age, immune status, chronicity of disease, and ease of establishing diagnosis (organism load) may be performed. Microbiological assessment 48 hours to 7 days after the completion of therapy is paramount for determining final outcome.

Evaluation of new anti-infective drugs for the treatment of cholera. Infectious

Cholera is an acute gastrointestinal infection caused by Vibrio cholerae. It is characterized by watery diarrhea that may lead to massive fluid loss, which in turn may result in hypotension, shock, and death within hours. Key to the treatment of cholera is fluid replacement. Anti-infective therapy decreases the severity and duration of diarrhea and the duration of shedding of V. cholerae. Enrolled patients should have diarrhea that is moderate to severe and a culture that ultimately yields V. cholerae. A prospective, randomized, active-controlled clinical trial is preferred. Studies should be double-blinded or evaluator-blinded. The rapidity with which the organism is eliminated from stool may be assessed. Both clinical and microbiological outcome should be determined. Assessment of microbiological eradication is paramount, since fluid replacement may suffice for treatment of signs and symptoms.

Evaluation of new anti-infective drugs for the treatment of typhoid fever. Infec

Typhoid fever is an acute febrile illness caused by Salmonella typhi. The evidence of blood-borne infection required for study entry includes clinical signs and symptoms plus confirmation of the presence of S. typhi in blood or other tissues or body fluids. The preferred study design is prospective and randomized with an active concurrent control. It is preferred that the investigator or an evaluator be blinded to therapy. In general, treatment should be administered for 2 weeks until it is demonstrated that a shorter course is as efficacious and as safe. Follow-up cultures of specimens from sites originally shown to be infected with S. typhi should be performed unless the diagnostic procedure places the patient at unnecessary risk.

Evaluation of new anti-infective drugs for the treatment of acute infectious dia

This guideline includes diarrhea causing infantile mortality in which a bacterial pathogen is recovered and for which oral rehydration therapy is an important component of care as well as traveler's diarrhea (with or without recovery of a pathogen). Diarrhea is defined as the passage of three or more unformed stools per day plus--in all patients except infants--one or more signs or symptoms of enteric infection. The preferred study design is prospective and randomized, with an active concurrent control and (when possible) blinding. Placebo-controlled trials may be performed if the severity of disease is judged by the investigator to be mild or moderate. It is desirable that both clinical and microbiological outcome be determined. Microbiological eradication is paramount.

Evaluation of new anti-infective drugs for the treatment of urinary tract infect

The term urinary tract infection (UTI) encompasses a broad range of clinical entities that share one characteristic: a positive urine culture. Clinical manifestations and responses to therapy are diverse even when comparable numbers of a particular bacterial species are identified on urine culture. These guidelines include discussion of acute uncomplicated cystitis, acute uncomplicated pyelonephritis, and complicated infections of the urinary tract. It is proposed that the finding of > or = 10(3) cfu/mL of urine defines significant bacteriuria in acute uncomplicated cystitis, > or = 10(4) cfu/mL in acute uncomplicated pyelonephritis and UTI in men, and > or = 10(5) cfu/mL in complicated UTI. The preferred clinical study design is prospective, randomized, and controlled with an active agent. Ideally, treatment with antimicrobial agents should eradicate the infecting organism, bring about the resolution of clinical signs and symptoms, have few adverse effects, and prevent reinfection.

Evaluation of new anti-infective drugs for the treatment of febrile episodes in

The use of empirical antimicrobial therapy has significantly reduced the morbidity and mortality associated with untreated infections in febrile neutropenic patients. This guideline describes clinical trials of the safety and efficacy of new antimicrobial drugs in this population of patients. Fever and neutropenia should be precisely defined in each protocol. Patients should be randomized to treatment with a new or active-control drug regimen, stratified on the basis of type of cancer and age, and treated until resolution--as defined in the protocol--is attained. Outcome should be assessed both for cases with a defined microbial etiology and for those without. Final microbiological outcome is important for cases with identified pathogens, but clinical outcome is paramount.

Evaluation of new anti-infective drugs for the treatment of toxoplasma encephali

Toxoplasma gondii is a protozoan that exists in three forms, all of which are potentially infectious for humans. After acute infection, cysts persist in the central nervous system and extraneural tissue. Human hosts with compromised immunity, particularly those with the acquired immunodeficiency syndrome, are vulnerable to reactivation and dissemination. The most common clinical expression of toxoplasma infection is encephalitis. The diagnosis is established by clinical presentation, computed tomography and/or magnetic resonance imaging, and detection of antibodies to T. gondii in serum of patients positive for human immunodeficiency virus. Brain biopsy may be performed. Protocols may be developed for the evaluation of new regimens for the treatment of acute encephalitis, the suppression of disease after treatment, or the prevention of reactivation before the onset of clinical disease. Assessment of clinical outcome is paramount.

Evaluation of new anti-infective drugs for the treatment of viral encephalitis.

Viral encephalitis may develop subsequent to viremia, via neuronal spread, or by arthropod vector. Diagnosis often requires invasive studies such as lumbar puncture and brain biopsy. This guideline addresses herpes simplex, rabies, and arbovirus infections of the central nervous system. Clinical trials should be designed according to the availability of approved therapeutic agents. Study designs with an active control (herpesvirus), a placebo control (arbovirus), or no control (rabies virus) are recommended. Outcome should be assessed 4-6 weeks, 4-6 months, and 11-13 months after the completion of therapy. For newborns with encephalitis, outcome should be assessed yearly through the age of 5 years. Assessment of clinical outcome is paramount.

Evaluation of new anti-infective drugs for the treatment of cryptococcal meningi

Cryptococcus neoformans may infect persons with intact or compromised host defenses. Clinical manifestations generally correlate directly with the degree of immunosuppression. Treatment is prescribed on the basis of the severity of disease and the degree of immunosuppression. Cryptococcal meningitis is the most common clinical form of cryptococcal infection and the most amenable to study in clinical trials. The current standard of care for cryptococcal meningitis is therapy with amphotericin B. Despite clinical improvement and microbiological suppression of the organism at the completion of therapy, the microbiological outcome will be identified as presumptive persistence if treatment is continued. Patients should be observed for 1 year after completion of therapy before a final assessment is made.

Evaluation of new anti-infective drugs for the treatment of acute bacterial meni

Predisposing conditions for acute bacterial meningitis include prematurity, young age, management in an intensive care setting, low socioeconomic background, and crowded living conditions. Clinical findings vary with age and may be nonspecific (altered feeding behavior) or specific (Kernig and Brudzinski signs). Examination and culture of cerebrospinal fluid (CSF) are essential for diagnosis. Antigen identification in CSF, serum, or urine by latex agglutination or other techniques can be useful in the identification of the pathogen. Randomized, controlled studies with a single-, double-, or evaluator-blinded design are encouraged. Among neonates, infants, and children, CSF should be examined again 24-36 hours after initiation of therapy. Outcomes should be judged by both clinical and microbiological criteria. Assessment of microbiological outcome is paramount.

Evaluation of new anti-infective drugs for the treatment of infections of prosth

Infections of a prosthetic hip are of three types: acute contiguous, chronic contiguous, and hematogenous. Acute contiguous infections result from contamination of the operative field at the time of surgery; clinical manifestations of infection become apparent within 6 months. Chronic contiguous infections are diagnosed 6-24 months postoperatively and are believed to be caused by intraoperative contamination. Hematogenous seeding of prosthetic joints accounts for infections that develop > or = 2 years after surgery. Fever and pain or dysfunction of the joint may be the only signs or symptoms of prosthetic hip joint infection. Definitive diagnosis is established by culture of a needle aspirate from the joint space or by intraoperative culture. Prospective, randomized, double-blind or evaluator-blinded, active-control comparative studies are preferable to open trials. Success rates 10-14 weeks after completion of a 4- to 6-week course of antimicrobial therapy should be > or = 90%.

Evaluation of new anti-infective drugs for the treatment of acute suppurative ar

Diagnostic criteria for bacterial suppurative arthritis include the demonstration of an inflammatory exudate by aspiration of synovial fluid and the isolation of bacteria from cultures of synovial fluid and/or blood. Clinical manifestations include joint effusion, swelling, tenderness, and pain, with or without redness of the overlying skin. Management consists of antimicrobial therapy, measures designed to relieve symptoms, surgical drainage of infected fluid, and physical therapy. Studies of new anti-infective therapy should be limited to cases of bacterial origin. Prospective, randomized, double-blind, or evaluator-blinded, active-control comparative clinical trials should be performed. Clinical response is characterized as success (cure), failure, or indeterminate outcome. The most common successful microbiological outcome is presumptive eradication. Follow-up should continue for 1 year before the final assessment.

Evaluation of new anti-infective drugs for the treatment of infectious arthritis

This guideline describes clinical trials of new anti-infective drugs for the treatment of septic arthritis due to bacteria other than Neisseria gonorrhoeae in adults. Septic arthritis is associated with fever and with physical findings at the affected joint. Diagnosis is established by culture of synovial fluid. Treatment includes the administration of antimicrobial drugs and drainage of the joint by needle aspiration or surgery. Multicenter, randomized comparative clinical trials that are single-, double-, or evaluator-blinded should be performed. However, an open trial of a new antimicrobial agent with historical controls is acceptable. Patients should receive treatment for at least 2-3 weeks. After 5 days of antimicrobial therapy, synovial fluid should be sterile and clinical signs and symptoms should have diminished. Patients should be followed for 2-4 weeks after completion of therapy.

Evaluation of new anti-infective drugs for the treatment of acute hematogenous o

Most children with acute hematogenous osteomyelitis have no preceding illness. Their early symptoms are pain and fever. A bacterial etiology is established in approximately 75% of cases by needle aspiration of the affected site or blood culture. Clinical trials should be limited to cases of bacterial origin. The antimicrobial agents studied should be active against Staphylococcus aureus and streptococci. If children < 5 years of age are included, the drug should also be active against beta-lactamase-negative and -positive strains of Haemophilus influenzae. Randomized, prospective, double-blind comparative studies are preferable to open, evaluator-blinded trials. Clinical outcome is appraised by physical signs and symptoms. A successful microbiological outcome consists of presumptive eradication. The final assessment should be made 1 year after completion of therapy.

Evaluation of new anti-infective drugs for the treatment of osteomyelitis in adu

Cases of osteomyelitis can be divided into four categories: acute hematogenous, vertebral, secondary to a contiguous focus of infection without vascular disease, and secondary to a contiguous focus of infection with vascular disease. Each category may be further divided into acute and chronic forms. Clinical symptoms persisting for > or = 10 days correlate roughly with the development of necrotic bone and chronic osteomyelitis. Patients enrolled in clinical trials should generally be > or = 12 years of age. Prior antimicrobial treatment does not exclude patients if the culture of a bone sample obtained at the time of enrollment yields pathogenic bacteria. Randomized, double-blind, active-control comparative studies are encouraged. Clinical outcome should be assessed during therapy and within 5-9 days, 4-6 weeks, and 11-13 months after completion of therapy. In the final assessment, clinical appraisal is paramount.

Evaluation of new anti-infective drugs for the treatment of selected infections

No method for classifying infections of the skin and skin structure is uniformly accepted. Therefore, each protocol for the evaluation of new anti-infective drugs must include definitions of the skin and skin-structure infections to be treated. Clinical findings may suggest the etiology. Cultures should be performed by the best available technique. Because the yield of pathogens from sites of skin and skin-structure infection is often low, monitoring of the clinical response to therapy is paramount. Randomized, double-blind, active-control comparative studies are needed, and maintenance of blinding is recommended, even with a change in the route of administration of the study and/or control drugs. The period of follow-up should be defined for each type of infection.

Evaluation of new anti-infective drugs for the treatment of syphilis. Infectious

Syphilis is caused by Treponema pallidum, a spirochetal bacterium pathogenic only for humans. The clinical course of disease is divided into three stages interspersed by periods of latency. Penicillin remains the treatment of choice for all stages of infection; tetracycline or erythromycin may be used as therapeutic alternatives in defined circumstances. Patients enrolled in clinical trials should be evaluated clinically, microscopically, and serologically for the presence of the spirochete. All participants, after undergoing counseling and giving informed consent, should be tested for infection with human immunodeficiency virus. Specific criteria exist for diagnosis of syphilis and response to therapy. It may be desirable to perform a small, uncontrolled, open trial of a new anti-infective drug for the collection of preliminary evidence of efficacy. A larger-scale, randomized, active-control comparative clinical trial is necessary to prove efficacy.

Evaluation of new anti-infective drugs for the treatment of sexually transmitted

This guideline addresses clinical trials of new antimicrobial agents in the treatment of uncomplicated genital infections caused by Chlamydia trachomatis and of syndromes resembling chlamydial infections. The most common clinical manifestations of chlamydial infection are urethritis in men and mucopurulent cervicitis in women. However, many chlamydial infections are not associated with inflammatory symptoms or signs. Culture is the diagnostic standard for defining the presence of C. trachomatis, although nonculture tests may be used in screening patients for enrollment in clinical trials. Susceptibility testing for C. trachomatis is laborious and difficult to standardize; only a few clinical isolates need to be tested in vitro. Prospective, randomized, double-blind, active-control comparative studies are recommended. Eradication of C. trachomatis defines both microbiological success and overall cure for chlamydial infection, but clinical and nonmicrobiological laboratory criteria are paramount in assessing the therapeutic response in nonchlamydial urethritis or cervicitis.

Evaluation of new anti-infective drugs for the treatment of uncomplicated gonorr

Gonorrhea is among the most common sexually transmitted diseases. Treatment for uncomplicated gonorrhea should be efficacious in > or = 95% of cases. Because patients with gonococcal infections often have other sexually transmitted diseases concurrently, individuals enrolled in clinical trials of therapy for gonorrhea should also be evaluated for infection with Chlamydia trachomatis and for syphilis. Testing for other pathogens should be considered in light of the clinical presentation. The presence of gonococcal infection is defined by a positive culture of a specimen obtained from an appropriate mucosal site. Patients enrolled in clinical trials should be otherwise-healthy adults who agree to return for follow-up assessment. These patients should be stratified by gender and anatomic site of infection. The preferred study design is a prospective, randomized, double-blind, active-control comparison. In some circumstances, however, historical controls may suffice. The study drug must have an efficacy rate of > or = 95% in genital and rectal infections. Microbiological eradication, demonstrated by negative cultures of samples from all potentially infected mucosal sites at follow-up, is the sole determinant of efficacy.

Evaluation of new anti-infective drugs for the treatment of vaginal infections.

The three major vaginal infections are yeast vulvovaginitis, Trichomonas vaginalis vaginitis, and bacterial vaginosis. In terms of signs and symptoms, these disorders overlap substantially with one another and with other infections. Therefore, the diagnosis of candidiasis and trichomoniasis requires isolation of the responsible pathogen. For the diagnosis of bacterial vaginosis, all other potential causes of vaginal infection must be excluded and specified laboratory criteria must be met. Clinical trials must be carefully designed to control for coexisting pathogens, for potential efficacy of treatment against more than one microbe, and for variable end points used to define clinical response. Prospective, randomized, double-blind, active-control comparative studies are preferred. Follow-up evaluations 5-7 days and 4-6 weeks after the completion of therapy are required for the assessment of outcome. Laboratory studies of vaginal fluid (culture and/or microscopic examination) are paramount in the final appraisal of outcome.

Evaluation of new anti-infective drugs for the treatment of chancroid. Infectiou

Chancroid is a mucocutaneous infection caused by Haemophilus ducreyi that produces ulcerative lesions and enhances the efficiency of transmission of human immunodeficiency virus (HIV). Confirmation of infection by culture of H. ducreyi is essential in therapeutic trials. Minimal inhibitory concentrations of antibiotics for the isolate should be determined by agar dilution. Patients should be evaluated by appropriate laboratory tests for syphilis, infection with herpes simplex virus, gonorrhea, and (in North America) infection with Chlamydia trachomatis. The clinical history of the disease should be recorded and ulcers, buboes, and lymphadenitis mass described. Whenever possible, study participants also should be tested for HIV infection. Randomized, prospective, double-blind, active-control comparative clinical trials are preferred for evaluation of the safety and efficacy of new anti-infective drugs. Otherwise-healthy men and women should be enrolled in these studies. Patients with active syphilis or genital herpes should be excluded. Microbiological and clinical outcomes are paramount.

Obtaining drugs from foreign markets.

Guidelines are presented for pharmacist coordination of the importation for use by institutionalized patients of drugs not currently approved by the FDA. A prerequisite for importation of foreign drugs is that traditional therapies have failed or are not an option. Steps that are required for drug importation and administration include completing an investigational new-drug application, obtaining institutional review board approval, obtaining informed consent, contacting a customs broker or the local FDA district import program manager, arranging for drug shipment, and documenting receipt and administration of the drug. Conditions are described under which portions of this process may be waived. By helping to ensure compliance with FDA requirements, pharmacists can expedite drug importation for institutionalized patients.

[Closed anesthetic systems].

Anaesthesia with closed anaesthetic systems demands knowledge of the physiology of the patients and of how the various anaesthetic gases behave in the organism as only the gases which the patients produces and absorbs are eliminated and replaced. The system is educational as it provides knowledge of the genuine absorption of oxygen and anaesthetic gases. The method is favourable to the environment as only the gases which are used are supplied and it is thus economical in use although investment in monitoring equipment is necessary. In practice, induction and waking of the patient are complicated with this system and it requires an anaesthetist who constantly adjusts the gases in the circuit.

Tuberculosis contact tracing: are the British Thoracic Society guidelines still

The joint response of the British Orthodontic Societies to the Nuffield Inquiry

1. Improving standards of dental health and greater awareness amongst the general public of the potential of dental treatment, including orthodontics have led to an increase in the number of patients seeking orthodontic advice. Yet there are insufficient orthodontists in Britain to meet the population's present need for orthodontic treatment. Moreover, the improved results expected from patients and professionals has led to an increase in the use of fixed appliances, which are more demanding of orthodontists' time. Despite attempts to rationalise treatment provision, the present number of British orthodontists remain unable to meet the need for treatment. This is indicated by the length of waiting lists in all branches of the service. Since there are no plans to expand the orthodontic profession, the present discrepancy between need for treatment and provision of treatment will not be resolved in the foreseeable future. 2. The orthodontic societies support the development of existing training programmes, career pathways and salary structures for dental surgery assistants, dental therapists, hygienists and technicians. Suitable courses need to be developed for people who have had a career break and wish to return to work. New courses also need to be designed for people entering training programmes in later life from a variety of backgrounds. Funds need to be identified in order to provide continuing education for all grades of ancillaries. 3. The development of a 'post basic' Training Course in Orthodontics for qualified dental surgery assistants is commended. A nationally approved certificate of training should be given to those who successfully complete a recognised course.(ABSTRACT TRUNCATED AT 250 WORDS)

Measurement standards for interdisciplinary medical rehabilitation.

Rehabilitation must address problems inherent in the measurement of human function and health-related quality of life, as well as problems in diagnosis and measurement of impairment. This educational document presents an initial set of standards to be used as guidelines for development and use of measurement and evaluation procedures and instruments for interdisciplinary, health-related rehabilitation. Part I covers general measurement principles and technical standards, beginning with validity, the central consideration for use of measures. Subsequent sections focus on reliability and errors of measurement, norms and scaling, development of measures, and technical manuals and guides. Part II covers principles and standards for use of measures. General principles of application of measures in practice are discussed first, followed by standards to protect persons being measured and then by standards for administrative applications. Many explanations, examples, and references are provided to help professionals understand measurement principles. Improved measurement will ensure the basis of rehabilitation as a science and nourish its success as a clinical service.

[Violent behavior of patients--is it predictable?].

In previous research on prediction of violent behaviour in patients some of the most important limitations have been lack of precision in defining violent behaviour, unsystematic registration of violence, and the fact that the prediction has been made valid for contexts other than that in which the original assessment was made. Of the neurobiological factors associated with violence, scientists have recently focused upon the serotonergic system in the central nervous system as being important. The authors review the literature on individual predictors of violent behaviour. Strong predictors seem to be previous violent behaviour, a high degree of hostility, suspiciousness and grandiosity, and current alcohol or drug abuse. The article includes suggestions for future research, and concludes with a presentation of guidelines for clinical assessment of risk of violence, with emphasis on recent events and observed behaviour.

[Organ donation from recently deceased patients. Experiences from a donor hospit

Homologous organ transplantation using organs from patients suffering complete destruction of the brain and brain stem is a major achievement in modern medicine. The care of potential organ donors and their relatives is complex and very demanding for the medical team and nursing staff. In Norway the law sets very clear criteria (documentation of total irreversible brain and brain stem injury) for performing donation. As a rule consent from the family is asked for, although not legally required. This article deals with the problems related to the treatment of potential organ donors. We give practical guidelines for medical staff on how to prepare the patient and his/her family, with emphasis on the human and psychosocial aspects. Preservation of the donor and the organs is not discussed.

HIV infection and AIDS: the ethics of medical confidentiality.

When do we treat hypercholesterolemia?

Although the relationships between elevated total and low-density lipoprotein (LDL) cholesterol and coronary heart disease (CHD) are relatively well established and published treatment guidelines are available, clinicians face a number of complex issues when deciding whom to treat. Specific patient characteristics and potential risk factors, of which less is known, may influence treatment decisions. In this presentation, the current guidelines for treating patients with hypercholesterolemia are reviewed and therapeutic issues that must be considered when selecting patients for treatment are identified.

Guidelines for transfusion of erythrocytes to neonates and premature infants. Fe

Confidentiality in the cancer registry.

Control of tuberculosis in the United States. American Thoracic Society.

TB continues to be a major public health problem in many areas of the United States. Elimination of this disease will require coordinated efforts of public health agencies, voluntary health associations, health-care providers, and community groups. TB controls is comprised of a variety of activities. Identification and treatment of patients with clinically active disease should be the highest priority for all TB control programs. Identification and preventive treatment of infected contacts and persons with tuberculous infection at greatest risk for developing disease (eg, HIV-infected, young children) should also receive high priority. Attention should then be given to identifying other high-risk groups and administering preventive therapy to those infected. While TB control occurs in many different settings, the health department TB control program plays a pivotal role in providing clinical services, and performing contact investigations, tuberculin-testing and prevention activities, surveillance, and evaluation of the community's overall progress in TB elimination. Health departments should receive strong and continuing support from medical care providers, voluntary health organizations, and community groups if TB elimination is to be achieved.