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The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews. Full English text available from:www.revespcardiol.org/en.

Editor's Note: This article is a reprint of a previously published article. For citation purposes, please use the original publication details: Harris RP, Helfand M, Woolf SH, et al. Current methods of the U.S. Preventive Services Task Force: a review of the process. Am J Prev Med. 2001;20(3S):21-35. The U.S. Preventive Services Task Force (USPSTF/Task Force) represents one of several efforts to take a more evidence-based approach to the development of clinical practice guidelines. As methods have matured for assembling and reviewing evidence and for translating evidence into guidelines, so too have the methods of the USPSTF. This paper summarizes the current methods of the third USPSTF, supported by the Agency for Healthcare Research and Quality (AHRQ) and two of the AHRQ Evidence-based Practice Centers (EPCs). The Task Force limits the topics it reviews to those conditions that cause a large burden of suffering to society and that also have available a potentially effective preventive service. It focuses its reviews on the questions and evidence most critical to making a recommendation. It uses analytic frameworks to specify the linkages and key questions connecting the preventive service with health outcomes. These linkages, together with explicit inclusion criteria, guide the literature searches for admissible evidence. Once assembled, admissible evidence is reviewed at three strata: (1) the individual study, (2) the body of evidence concerning a single linkage in the analytic framework, and (3) the body of evidence concerning the entire preventive service. For each stratum, the Task Force uses explicit criteria as general guidelines to assign one of three grades of evidence: good, fair, or poor. Good or fair quality evidence for the entire preventive service must include studies of sufficient design and quality to provide an unbroken chain of evidence-supported linkages, generalizable to the general primary care population, that connect the preventive service with health outcomes. Poor evidence contains a formidable break in the evidence chain such that the connection between the preventive service and health outcomes is uncertain. For services supported by overall good or fair evidence, the Task Force uses outcomes tables to help categorize the magnitude of benefits, harms, and net benefit from implementation of the preventive service into one of four categories: substantial, moderate, small, or zero/negative. The Task Force uses its assessment of the evidence and magnitude of net benefit to make a recommendation, coded as a letter: from A (strongly recommended) to D (recommend against). It gives an I recommendation in situations in which the evidence is insufficient to determine net benefit. The third Task Force and the EPCs will continue to examine a variety of methodologic issues and document work group progress in future communications.

Objectives The aim of the study was to generate a comprehensive bank of systematic review (SR) reporting items to inform an update of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2009 statement. Methods We searched the Enhancing the QUAlity and Transparency Of health Research Network library in May 2019 to identify all reporting guidelines for SRs that were published after 2009, regardless of the scope of the guideline. We also conducted a selective review of four guidance manuals for SRs, three tools for assessing the risk of bias in SRs, six meta-research studies evaluating the reporting quality of SRs using a tailored checklist, and five reporting guidelines for other study designs. One author screened and selected sources for inclusion, extracted reporting guidance from sources, and mapped guidance against the PRISMA 2009 checklist items. Results We included 60 sources providing guidance on reporting of SRs and meta-analyses. From these, we collated a list of 221 unique reporting items. Items were categorized into title (four items), abstract (10 items), introduction (12 items), methods (111 items), results (61 items), discussion (12 items), funding and conflicts of interest (four items), administrative information (three items), and data availability (four items). This exercise generated 175 reporting items that could be added to the guidance in the PRISMA 2009 statement. Conclusion Generation of a comprehensive item bank through review and mapping of the literature facilitates identification of missing items and those needing modification, which may not otherwise be identified by the guideline development team or from other activities commonly used to develop reporting guidelines.

Uvod: Preporučene smjernice za izvještavanje u sustavnim pregledima i metaanalizama (engl. Preferred Reporting Items for Systematic reviews and Meta-Analyses, PRISMA) prvi su puta objavljene 2009. godine kako bi autorima sustavnih pregleda omogućile transparentno izvještavanje o predmetu istraživanja, korištenim metodama i dobivenim rezultatima. Tijekom posljednjeg desetljeća postignut je značajan napredak u metodologiji i terminologiji sustavnih pregleda, što je rezultiralo potrebom za nadopunjavanjem i prilagođavanjem postojećih smjernica. Svrha rada: Predstaviti ažurirane smjernice PRISMA 2020. za izvještavanje u sustavnim pregledima. Metode: Pregledali smo 60 dokumenata sa smjernicama za izvještavanje u sustavnim pregledima s ciljem obuhvaćanja predloženih izmjena smjernica PRISMA iz 2009. godine. Tražili smo povratne informacije o predloženim izmjenama pomoću internetske ankete provedene među 110 urednika časopisa i metodologa sustavnih pregleda. O rezultatima anketa i pregleda raspravljalo se na sastanku na kojem je sudjelovao 21 član. Nakon sastanka, temeljem povratnih informacija koautora i prigodnog uzorka od 15 recenzenata sustavnih pregleda, generirali smo koncept za kontrolni popis PRISMA 2020., sažetak kontrolnog popisa, razradu i objašnjenje te dijagram toka. Rezultati: U ovom radu predstavljamo kontrolni popis za smjernice PRISMA 2020. sastavljene od 27 stavki, odnosno prošireni kontrolni popis s detaljnim preporukama za izvještavanje pojedine stavke, sažetak kontrolnog popisa PRISMA 2020. te revidirane dijagrame toka za izvorne i ažurirane preglede. Kontrolni popis uključuje nove smjernice za izvještavanje koje sadrže ažurirane metode identifikacije, odabira, procjene i sinteze istraživanja. Struktura i prikaz stavaka su izmijenjeni kako bi se olakšala njihova provedba. Smjernice PRISMA 2020. zamjenjuju smjernice iz 2009. godine. Zaključak: Svrha smjernica PRISMA 2020. je olakšati transparentnost, cjelovitost i točnost izvještavanja u sustavnim pregledima. Poboljšano izvještavanje koristiti će autorima sustavnih pregleda, autorima smjernica, kreatorima politike, zdravstvenim radnicima, pacijentima i drugim korisnicima. U svrhu postizanja navedenih ciljeva potičemo autore, urednike i recenzente da usvoje predstavljene smjernice.

The methods and results of systematic reviews should be reported in sufficient detail to allow users to assess the trustworthiness and applicability of the review findings. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement was developed to facilitate transparent and complete reporting of systematic reviews and has been updated (to PRISMA 2020) to reflect recent advances in systematic review methodology and terminology. Here, we present the explanation and elaboration paper for PRISMA 2020, where we explain why reporting of each item is recommended, present bullet points that detail the reporting recommendations, and present examples from published reviews. We hope that changes to the content and structure of PRISMA 2020 will facilitate uptake of the guideline and lead to more transparent, complete, and accurate reporting of systematic reviews.

Objectives To describe the processes used to update the PRISMA 2009 statement for reporting systematic reviews, present results of a survey conducted to inform the update, summarize decisions made at the PRISMA update meeting, and describe and justify changes made to the guideline. Methods We reviewed 60 documents with reporting guidance for systematic reviews to generate suggested modifications to the PRISMA 2009 statement. We invited 220 systematic review methodologists and journal editors to complete a survey about the suggested modifications. The results of these projects were discussed at a 21-member in-person meeting. Following the meeting, we drafted the PRISMA 2020 statement and refined it based on feedback from co-authors and a convenience sample of 15 systematic reviewers. Results The review of 60 documents revealed that all topics addressed by the PRISMA 2009 statement could be modified. Of the 110 survey respondents, more than 66% recommended keeping six of the original checklist items as they were and modifying 15 of them using wording suggested by us. Attendees at the in-person meeting supported the revised wording for several items but suggested rewording for most to enhance clarity, and further refinements were made over six drafts of the guideline. Conclusions The PRISMA 2020 statement consists of updated reporting guidance for systematic reviews. We hope that providing this detailed description of the development process will enhance the acceptance and uptake of the guideline and assist those developing and updating future reporting guidelines.

In Annals' first rapid, living systematic review, Chou and colleagues examined the burden of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), SARS-CoV-1, and Middle East respiratory syndrome coronavirus on health care workers and risk factors for infection. The editorialists discuss the role of these review types and describe the features they will look for when Annals is considering rapid and living reviews for publication.

Assel and Vickers report the shortcomings of statistical code supporting research reports in high-impact medical journals. In this editorial, Annals' statistical editors argue that clearly presente...

The PRISMA statement is a reporting guideline designed to improve the completeness of reporting of systematic reviews and meta-analyses. Authors have used this guideline worldwide to prepare their reviews for publication. In the past, these reports typically compared 2 treatment alternatives. With the evolution of systematic reviews that compare multiple treatments, some of them only indirectly, authors face novel challenges for conducting and reporting their reviews. This extension of the PRISMA (Preferred Reporting Items for Systematic Reviews and Metaanalyses) statement was developed specifically to improve the reporting of systematic reviews incorporating network meta-analyses.

In meta-analyses, researchers combine data from individual studies into a summary measure to describe the benefits or harms of an intervention. This installment of the “Understanding Clinical Resea...

A primary goal of meta-analysis is to improve the estimation of treatment effects by pooling results of similar studies. This article discusses the problems associated with using the DerSimonian–La...

Heterogeneity of treatment effects (HTE) refers to the non-random variation in the magnitude or direction of a treatment effect across levels of a covariate, as measured on a selected scale, against a clinical outcome. In randomized controlled trials (RCTs), it is typically examined through subgroup analysis contrasting effects in groups of patients defined one-variable-at-a-time (e.g. males versus female; old versus young). Herein, we present guidance on an alternative approach to HTE analysis, predictive HTE analysis. The goal of predictive HTE analysis is to provide patient-centered estimates of outcome risks with versus without the intervention, taking into account all relevant patient attributes simultaneously. The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement was developed using: a multidisciplinary technical expert panel; targeted literature reviews; simulations to characterize potential problems with predictive approaches; and a deliberative process engaging the expert panel. We distinguished two categories of predictive HTE approaches: 1) a “risk modeling” approach wherein a multivariable model predicts the risk of an outcome and is applied to disaggregate patients within RCTs to define risk-based variation in benefit; and 2) an “effect modeling” approach wherein a model is developed on RCT data by incorporating a term for treatment assignment and interactions between treatment and baseline covariates. Both approaches can be used to predict differential absolute treatment effects, the most relevant scale for clinical decision-making. We developed four sets of guidance: 1) criteria to determine when risk modeling approaches are likely to identify clinically important HTE; 2) methodological aspects of risk modeling methods; 3) considerations for translation to clinical practice; and 4) considerations and caveats in the use of effect modeling approaches. The PATH Statement, together with the PATH Statement Explanation and Elaboration document, may guide future analyses and reporting of RCTs.

In this issue, Navarese and colleagues' meta-analysis provides important preliminary information on clinical outcomes of PCSK9 inhibitors as the U.S. Food and Drug Administration considers approval...

Elders undergo approximately 40% of more than 1 million major abdominal operations annually. Yet evidence about recovery to preoperative levels of functional independence is limited. This study details course and predictors of functional recovery after elective major abdominal operations in the elderly.This was a prospective cohort of 372 consecutive patients, 60 years old or more, enrolled from surgeons in private practice and two university-affiliated hospitals, assessed preoperatively and postoperatively at 1, 3, and 6 weeks, 3 and 6 months, using self-report and performance-based measures (Activities of Daily Living [ADL], Instrumental Activities of Daily Living [IADL], Medical Outcomes Study Short Form-36 Physical Component and Mental Component Scales [PCS, MCS], Geriatric Depression Scale [GDS], Folstein Mini-Mental State Exam [MMSE], timed walk, functional reach, hand grip strength).Mean age was 69 +/- 6 years with 56% men, 47% nonHispanic Caucasian, and 42% Mexican American; hospital distribution was 49% private, 51% university-affiliated. Maximum functional declines (95% CI) occurred 1 week postoperatively: ADL, 2.8 points (2.4 to 3.2); IADL, 7.6 points (7 to 8.3); SF-36 PCS, 6.5 points (5.4 to 7.6); Mini-Mental State Exam, 0.5 points (0.2 to 0.7); timed walk, 6.8 seconds (5.2 to 8.4); functional reach, 1.7 inches (1.2 to 2.2); grip strength, 2 kilograms (1.3 to 2.7) (p0.001 for all). SF-36 mental component scale and Geriatric Depression Scale scores did not worsen. Mean recovery times were: Mini-Mental State Exam, 3 weeks; timed walk, 6 weeks; ADL, SF-36 PCS, and functional reach, 3 months; and IADL, 6 months. Mean grip strength did not return to preoperative status by 6 months. The incidence of persistent disability at 6 months, compared with preoperative status, was: ADL, 9%; IADL, 19%; PCS, 16%; mental component scale, 17%; timed walk, 39%; functional reach, 58%; and grip strength, 52%. Potentially modifiable independent predictors of ADL and IADL recovery were preoperative physical conditioning and depression plus serious postoperative complications.The clinical course of functional recovery varied across different measures. Protracted disability at 6 months after operation was substantial. Several potentially modifiable factors consistently predicted recovery.

Heart to Heart is a computer-based decision aid for patients and providers that provides personalized, evidence-based information about coronary heart disease (CHD) risk and potential risk-reducing interventions. To develop Heart to Heart, the authors used Framing-ham risk equations and systematic reviews of risk-reducing interventions. The Web version was programmed using PHP: Hypertext Processor, a Web-based programming language, and has separate interfaces for providers and patients. The authors subsequently developed a modified version for personal digital assistants. Heart to Heart uses information about a patient's CHD risk factors (age, gender, total and high-density lipoprotein cholesterol levels, diabetes, smoking, systolic blood pressure, and left ventricular hypertrophy) to calculate risk of total CHD events over 5 or 10 years. Patients and providers can then examine the effect of introducing one or more risk-reducing interventions (aspirin, lipid-lowering drug therapy, antihypertensive medication, or smoking cessation) on the patient's CHD risk. Future research will be directed to determining whether Heart to Heart can improve utilization of effective CHD risk-reducing interventions.

PURPOSE: To examine the features of available Framingham-based risk calculation tools and review their accuracy and feasibility in clinical practice. DATA SOURCES: medline, 1966–April 2003, and the google search engine on the Internet. TOOL AND STUDY SELECTION: We included risk calculation tools that used the Framingham risk equations to generate a global coronary heart disease (CHD) risk. To determine tool accuracy, we reviewed all articles that compared the performance of various Framingham-based risk tools to that of the continuous Framingham risk equations. To determine the feasibility of tool use in clinical practice, we reviewed articles on the availability of the risk factor information required for risk calculation, subjective preference for 1 risk calculator over another, or subjective ease of use. DATA EXTRACTION: Two reviewers independently reviewed the results of the literature search, all websites, and abstracted all articles for relevant information. DATA SYNTHESIS: Multiple CHD risk calculation tools are available, including risk charts and computerized calculators for personal digital assistants, personal computers, and web-based use. Most are easy to use and available without cost. They require information on age, smoking status, blood pressure, total and HDL cholesterol, and the presence or absence of diabetes. Compared to the full Framingham equations, accuracy for identifying patients at increased risk was generally quite high. Data on the feasibility of tool use was limited. CONCLUSIONS: Several easy-to-use tools are available for estimating patients’ CHD risk. Use of such tools could facilitate better decision making about interventions for primary prevention of CHD, but further research about their actual effect on clinical practice and patient outcomes is required. DISCLOSURE: Drs. Sheridan and Pignone have participated in the development of Heart-to-Heart, one of the risk tools evaluated within. They have also received speaking and consulting fees from Bayer, Inc. Bayer, Inc. has licensed the Heart-to-Heart tool.

In May The BMJ corrected an error relating to adverse effects of statins in two articles but was asked to retract the articles. The editor referred the decision to an expert panel. Here, we publish its findings

In this issue, 3 articles address vitamin and mineral supplements for prevention of chronic diseases. The editorialists discuss the articles' findings and their implications for public health and r...

The U.S. Preventive Services Task Force (USPSTF/Task Force) represents one of several efforts to take a more evidence-based approach to the development of clinical practice guidelines. As methods have matured for assembling and reviewing evidence and for translating evidence into guidelines, so too have the methods of the USPSTF. This paper summarizes the current methods of the third USPSTF, supported by the Agency for Healthcare Research and Quality (AHRQ) and two of the AHRQ Evidence-based Practice Centers (EPCs). The Task Force limits the topics it reviews to those conditions that cause a large burden of suffering to society and that also have available a potentially effective preventive service. It focuses its reviews on the questions and evidence most critical to making a recommendation. It uses analytic frameworks to specify the linkages and key questions connecting the preventive service with health outcomes. These linkages, together with explicit inclusion criteria, guide the literature searches for admissible evidence. Once assembled, admissible evidence is reviewed at three strata: (1) the individual study, (2) the body of evidence concerning a single linkage in the analytic framework, and (3) the body of evidence concerning the entire preventive service. For each stratum, the Task Force uses explicit criteria as general guidelines to assign one of three grades of evidence: good, fair, or poor. Good or fair quality evidence for the entire preventive service must include studies of sufficient design and quality to provide an unbroken chain of evidence-supported linkages, generalizable to the general primary care population, that connect the preventive service with health outcomes. Poor evidence contains a formidable break in the evidence chain such that the connection between the preventive service and health outcomes is uncertain. For services supported by overall good or fair evidence, the Task Force uses outcomes tables to help categorize the magnitude of benefits, harms, and net benefit from implementation of the preventive service into one of four categories: substantial, moderate, small, or zero/negative. The Task Force uses its assessment of the evidence and magnitude of net benefit to make a recommendation, coded as a letter: from A (strongly recommended) to D (recommend against). It gives an I recommendation in situations in which the evidence is insufficient to determine net benefit. The third Task Force and the EPCs will continue to examine a variety of methodologic issues and document work group progress in future communications.

Abstract: As medical technology continues to expand and the cost of using all effective clinical services exceeds available resources, decisions about health care delivery may increasingly rely on assessing the cost-effectiveness of medical services. Cost-effectiveness is particularly relevant for decisions about how to implement preventive services, because these decisions typically represent major investments in the future health of large populations. As such, decisions regarding the implementation of preventive services frequently involve, implicitly if not explicitly, consideration of costs. Cost-effectiveness analysis summarizes the expected benefits, harms, and costs of alternative strategies to improve health and has become an important tool for explicitly incorporating economic considerations into clinical decision making. Acknowledging the usefulness of this tool, the third U.S. Preventive Services Task Force (USPSTF) has initiated a process for systematically reviewing cost-effectiveness analyses as an aid in making recommendations about clinical preventive services. In this paper, we provide an overview and examples of roles for using cost-effectiveness analyses to inform preventive services recommendations, discuss limitations of cost-effectiveness data in shaping evidence-based preventive health care policies, outline the USPSTF approach to using cost-effectiveness analyses, and discuss the methods the USPSTF is developing to assess the quality and results of cost-effectiveness studies. While this paper focuses on clinical preventive services (i.e., screening, counseling, immunizations, and chemoprevention), the framework we have developed should be broadly portable to other health care services.

Context: Screening and treatment of lipid disorders in people at high risk for future coronary heart disease (CHD) events has gained wide acceptance, especially for patients with known CHD, but the proper role in people with low to medium risk is controversial. Objective: To examine the evidence about the benefits and harms of screening and treatment of lipid disorders in adults without known cardiovascular disease for the U.S. Preventive Services Task Force. Data Sources: We identified English-language articles on drug therapy, diet and exercise therapy, and screening for lipid disorders from comprehensive searches of the MEDLINE database from 1994 through July 1999. We used published systematic reviews, hand searching of relevant articles, the second Guide to Clinical Preventive Services , and extensive peer review to identify important older articles and to ensure completeness. Data Synthesis: There is strong, direct evidence that drug therapy reduces CHD events, CHD mortality, and possibly total mortality in middle-aged men (35 to 65 years) with abnormal lipids and a potential risk of CHD events greater than 1% to 2% per year. Indirect evidence suggests that drug therapy is also effective in other adults with similar levels of risk. The evidence is insufficient about benefits and harms of treating men younger than 35 years and women younger than 45 years who have abnormal lipids but no other risk factors for heart disease and low risk for CHD events (less than 1% per year). Trials of diet therapy for primary prevention have led to long-term reductions in cholesterol of 3% to 6% but have not demonstrated a reduction in CHD events overall. Exercise programs that maintain or reduce body weight can produce short-term reductions in total cholesterol of 3% to 6%, but longer-term results in unselected populations have found smaller or no effect. To identify accurately people with abnormal lipids, at least two measurements of total cholesterol and high-density lipoprotein cholesterol are required. The role of measuring triglycerides and the optimal screening interval are unclear from the available evidence. Conclusions: On the basis of the effectiveness of treatment, the availability of accurate and reliable tests, and the likelihood of identifying people with abnormal lipids and increased CHD risk, screening appears to be effective in middle-aged and older adults and in young adults with additional cardiovascular risk factors.

When judging the benefits and harms of health care and predicting patient prognosis, clinicians, researchers, and others must consider many types of evidence. Medical research evidence is part of the required knowledge base,and practitioners of evidence-based medicine must attempt to integrate the best available clinical evidence from systematic research with health professionals' expertise and patients' rights to be informed about diagnostic and therapeutic options available to them. Judging what constitutes sound evidence can be difficult because of, among other things, the sheer quantity,diversity, and complexity of medical evidence available today; the various scientific methods that have been advanced for assembling, evaluating, and interpreting such information; and the guides for applying medical research evidence to individual patients' situations. Recommendations based on sound research can then be brought forward as either guidelines or standards, and criteria exist by which valid guidelines and standards can be developed and promulgated. Nonetheless, gaps and deficiencies exist in current guidelines and in the methods for finding and synthesizing evidence. Interpreting and judging medical research involves subjective, not solely explicit, processes. Thus, developments in evidence-based medicine are an aid, but not a panacea,for definitively establishing benefits and harms of medical care, and the contributions that medical research evidence can make in any clinical or legal situation must be understood in a context in which judgment and values,understanding of probability, and tolerance for uncertainty all play a role.

Garlic is a popular herbal alternative therapy. Adverse effects of garlic that have been reported with oral ingestion, inhalation, and topical exposure include smelly breath, body odor, flatulence, esopha-geal and abdominal pain, small intestinal obstruction, contact dermatitis, rhinitis, asthma, bleeding, myocardial infarction, urticaria, angioedema, anaphylaxis, skin blisters, and ulcero-necrotic lesions. Causality of garlic for specific adverse effects is best established for smelly breath, body odor, and allergic reactions; data regarding other adverse effects are primarily based on case reports. The frequency of adverse effects of garlic and whether they vary by particular preparations are not established.

Objective: To conduct a systematic review of evidence relating to management of mild chronic hypertension during pregnancy, including associated risks, benefits, and harms of treatment with antihypertensive agents, nonpharmacologic measures, and aspirin and benefits of various monitoring strategies. Data Sources: Using four broad search strategies, we searched English and non–English-language citations in 16 electronic databases from their inception to February 1999 and consulted relevant textbooks, references, and experts. Study Selection: Reviewers screened 6228 abstracts and found 215 articles that met multiple prespecified patient selection, study population, and design criteria. Tabulation, Integration, and Results: Forty-six studies consistently showed that chronic hypertension triples the risk for perinatal mortality (odds ratio [OR] 3.4; 95% confidence interval [CI] 3.0, 3.7) and doubles the risk for placental abruption (OR 2.1; 95% CI 1.1, 3.9). Thirteen small, randomized controlled trials had inadequate power to rule in or rule out moderate-to-large (20%–50%) benefits of antihypertensive treatment. Possible adverse effects were fetal renal failure when angiotensin-converting enzyme inhibitors are used in the second or third trimester and growth restriction when atenolol is used early in pregnancy. Trials showed that aspirin neither reduces nor increases perinatal and maternal morbidity, but they did not rule out possible small-to moderate beneficial or adverse effects. No studies provide guidance on benefits or consequences of various nonpharmacologic therapies or monitoring strategies. Conclusion: Mild chronic hypertension is associated with increased maternal and fetal risks. Beneficial treatment and monitoring regimens are not clear, but some treatments, such as angiotensin-converting enzyme inhibitors, are best avoided.

PURPOSE: Depression is a highly prevalent, morbid, and costly illness that is often unrecognized and inadequately treated. Because depression questionnaires have the potential to improve recognition, we evaluated the accuracy and effects on primary care of two case-finding instruments compared to usual care. SUBJECTS AND METHODS: The study was conducted at three university-affiliated and one community-based medical clinics. Consecutive patients were randomly assigned to be asked a single question about mood, to fill out the 20-item Center for Epidemiologic Studies Depression Screen, or to usual care. Within 72 hours, patients were assessed for Diagnostic and Statistical Manual of Mental Disorders Third Revised Edition (DSM-III-R) disorders by an assessor blinded to the screening results. Process of care was assessed using chart audit and administrative databases; patient and physician satisfaction was assessed using Likert scales. At 3 months, depressed patients and a random sample of nondepressed patients were re-assessed for DSM-III-R disorders and symptom counts. RESULTS: We approached 1,083 patients, of whom 969 consented to screening and were assigned to the single question (n = 330), 20-item questionnaire (n = 323), or usual care (n = 316). The interview for DSM-III-R diagnosis was completed in 863 (89%) patients; major depression, dysthymia, or minor depression was present in 13%. Both instruments were sensitive, but the 20-item questionnaire was more specific than the single question (75% vs 66%, P = 0.03). The 20-item questionnaire was less likely to be self-administered (54% vs 90%) and took significantly more time to complete (15 vs 248 seconds). Case-finding with the 20-item questionnaire or single question modestly increased depression recognition, 30/77 (39%) compared with 11/38 (29%) in usual care ( P = 0.31) but did not affect treatment (45% vs 43%, P = 0.88). Effects on DSM-III-R symptoms were mixed. Recovery from depression was more likely in the case-finding than usual care groups, 32/67 (48%) versus 8/30 (27%, P = 0.03), but the mean improvement in depression symptoms did not differ significantly (1.6 vs 1.5 symptoms, P = 0.21). CONCLUSIONS: A simple question about depression has similar performance characteristics as a longer 20-item questionnaire and is more feasible because of its brevity. Case-finding leads to a modest increase in recognition rates, but does not have consistently positive effects on patient outcomes.

Last Friday, I had a particularly busy clinic day. One of my first appointments was with a 23-year-old African-American man who described frequent episodes of feelings of doom, thundering and racing in his chest, and difficulty breathing. I diagnosed panic attacks. Knowing that depression is common among persons with panic attacks, I asked about his mood and discovered that he was suffering from major depression, a condition that had occurred once 4 years earlier when he entered college. After exploring issues concerning the etiology and appropriate treatment of his current problems, the patient and I elected medical therapy for his depression and referral to a behaviorist for his panic attacks. I felt good about the encounter, but it had taken 30 minutes, and I was 15 minutes late for my next appointment. She was a middle-aged, obese, Hispanic woman with reasonably well-controlled diabetes. She had no specific complaints. While I was examining her feet and diagnosing osmidrosis, the previous patient popped into my mind, and I reminded myself that depression also was common among middle-aged women. Buoyed by the apparent success of my previous exploration of depression symptoms, I questioned her about her mood and her recent enjoyment and satisfaction with life. At first she didn't know what I was talking about, but as I made my questions clearer (and the interview longer), she clearly denied having any problems. My next four patients were men over 60 years of age. Prodded by the lateness of my schedule, the lack of obvious psychiatric problems in these patients, and the rationalization that major depression is less common in men than women and in elderly than middle-aged persons, I queried none of them about depression. Rather, I adjusted antihypertensive regimens, pondered whether the laboratory had confused a glycosylated hemoglobin level with a serum hemoglobin value, and doled out an alpha agent for the patient with “chronic plumbing problems.” I finished clinic late and missed lunch, but for the most part, I thought I had done a pretty good job.

To review the diagnostic utility of the chest radiograph for left ventricular dysfunction.Structured MEDLINE searches, citation reviews of relevant primary research, review articles, and textbooks, personal files, and data from experts.Studies of patients without valvular disease that allowed calculation of the sensitivity and specificity of selected radiographic signs compared with a criterion standard of increased left ventricular preload or reduced ejection fraction.Two independent readers reviewed 29 studies. Studies were pooled after stratification by radiographic finding, criterion standard, and clinical setting.Redistribution best diagnosed increased preload with a sensitivity of 65% (95% confidence interval [CI] 55%, 75%) and specificity 67% (95% CI 53%, 79%). Cardiomegaly best diagnosed decreased ejection fraction with a sensitivity of of 51% (95% CI 43%, 60%) and specificity of 79% (95% CI 71%, 85%). Interrater reliability was fair to moderate for redistribution and moderate for cardiomegaly. The clinical setting affected results by decreasing the specificity of cardiomegaly to 8% in detecting increased preload in patients with severe systolic dysfunction. The absence of redistribution could only exclude increased preload in situations in which the suspicion (pretest probability) of disease was less than 9%, whereas redistribution could confirm increased preload when the pretest probability was greater than 91%. The absence of cardiomegaly could only exclude a reduced ejection fraction if the pretest probability was less than 8%, whereas cardiomegaly could confirm a reduced ejection fraction if the pretest probability was greater than 87%.Redistribution and cardiomegaly are the best chest radiographic findings for diagnosing increased preload and reduced ejection fraction, respectively. Unfortunately, neither finding alone can adequately exclude or confirm left ventricular dysfunction in usual clinical settings. Redistribution is not always reliably interpreted.

Objective: To investigate if extracts of Hypericum perforatum (St John9s wort) are more effective than placebo in the treatment of depression, are as effective as standard antidepressive treatment, and have fewer side effects than standard antidepressant drugs. Design: Systematic review and meta-analysis of trials revealed by searches. Trials: 23 randomised trials including a total of 1757 outpatients with mainly mild or moderately severe depressive disorders: 15 (14 testing single preparations and one a combination with other plant extracts) were placebo controlled, and eight (six testing single preparations and two combinations) compared hypericum with another drug treatment. Main outcome measures: A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group), and numbers of patients reporting and dropping out for side effects. Results: Hypericum extracts were significantly superior to placebo (ratio = 2.67; 95% confidence interval 1.78 to 4.01) and similarly effective as standard antidepressants (single preparations 1.10; 0.93 to 1.31, combinations 1.52; 0.78 to 2.94). There were two (0.8%) drop outs for side effects with hypericum and seven (3.0%) with standard antidepressant drugs. Side effects occurred in 50 (19.8%) patients on hypericum and 84 (52.8%) patients on standard antidepressants. Conclusion: There is evidence that extracts of hypericum are more effective than placebo for the treatment of mild to moderately severe depressive disorders. Further studies comparing extracts with standard antidepressants in well defined groups of patients and comparing different extracts and doses are needed. Key messages There is evidence from randomised trials that such extracts are more effective than placebo for the treatment of depressive disorders, but it is not known whether they are more effective for certain disorders than others Current evidence is inadequate to establish whether hypericum is as effective as other antidepressants and if it has fewer side effects Additional trials should be conducted to compare hypericum with other antidepressants in well defined groups of patients; to investigate long term side effects; and to evaluate the relative efficacy of different preparations and doses

OBJECTIVE: To evaluate differences in functional status and burdens of medical conditions in Mexican American and non-Hispanic white nursing home residents. DESIGN AND SETTING: Cross-sectional survey of 17 nursing homes in south Texas. PARTICIPANTS: A total of 617 older nursing home residents, of whom 366 were Mexican American and 251 were non-Hispanic white. MEASURES: Activities of Daily Living (ADL) status abstracted from standard nurses notes and Burden of Disease abstracted from medical records. RESULTS: Mexican American residents had greater numbers of ADL dependencies and poorer overall ADL scores than non-Hispanic white residents. This poor functioning was not explained by age, gender, or marital or educational status. The average number of medical conditions was greater, and specific conditions, such as cerebrovascular disease, recent acute infections, diabetes, hypertension, and anemia, were more common in Mexican American residents compared with non-Hispanic white residents. In models relating function with medical conditions and ethnic group, ADL scores and dependencies were significantly related to bowel and bladder incontinence, cerebrovascular disease, dementia, recent infections, and skin decubiti, but not to ethnic group. CONCLUSION: Mexican American nursing home residents are more functionally dependent than non-Hispanic white residents. The difference in function is explained by a greater burden of medical conditions in the Mexican American residents. J Am Geriatr Soc 44:279–284, 1996.

Following proposals in 1987 and 1988, several medical journals have provided more informative abstracts (“structured abstracts”) for articles of clinical interest. Structured abstracts for original studies require authors to systematically disclose the objective, basic research design, clinical setting, participants, interventions (if any), main outcome measurements, results, and conclusions; and for literature reviews the objective, data sources, methods of study selection, data extraction and synthesis, and conclusions. More informative abstracts of this kind can facilitate peer review before publication, assist clinical readers to find articles that are both scientifically sound and applicable to their practices, and allow more precise computerized literature searches. We review the feasibility, acceptability, and dissemination of structured abstracts, reassess the underlying strategy, and describe modifications of the approach. This innovation can aid communication from scientists to clinicians, and other clinical journals are invited to join this effort.

Internists frequently evaluate preoperative cardiopulmonary risk and co-manage cardiac and pulmonary complications, but the comparative incidence and clinical importance of these complications are not clearly delineated. This study evaluated incidence and length of stay for both cardiac and pulmonary complications after elective laparotomy.Nested case-control.University-affiliated Department of Veterans Affairs Hospital.Computerized registry of all 2,291 patients undergoing elective abdominal operations from 1982 to 1991.Strategy for ascertainment and verification of complications was systematic and explicit. The charts of all 116 patients identified by the registry as having complications and 412 (19%) randomly selected from 2,175 remaining patients were reviewed to verify presence or absence of cardiac or pulmonary complications, using explicit criteria and independent abstraction of pre- and postoperative components of charts. From these 528 validated cases and controls (23% of the cohort), 96 cases and 96 controls were matched by operation type and age within ten years. Hospital and intensive care unit stays were significantly longer (p0.0001) for the cases than for the controls (24.1 vs 10.3 and 5.6 vs 1.5 days, respectively). All 19 deaths occurred among the cases. Among the cases, pulmonary complications occurred significantly more often than cardiac complications (p0.00001) and were associated with significantly longer hospital stays (22.7 vs 10.4 days, p = 0.001). Combined cardiopulmonary complications occurred among 28% of the cases. Misclassification-corrected incidence rates for the entire cohort were 9.6% (95% CI 7.2-12.0) for pulmonary and 5.7% (95% CI 3.6-7.7) for cardiac complications.For noncardiac surgery, previous research has focused on cardiac risk. In this study, pulmonary complications were more frequent, were associated with longer hospital stay, and occurred in combination with cardiac complications in a substantial proportion of cases. These results suggest that further research is needed to fully characterize the clinical epidemiology of postoperative cardiac and pulmonary complications and better guide preoperative risk assessment.

The aim of this cohort study was to evaluate the concordance of the Sickness Impact Profile for Nursing Homes (SIP- NH) and Sickness Impact Profile (SIP) in classifying change. Subjects consisted of 194 consecutive long- stay nursing home residents at one academic department of the V.A. and in 8 community proprietary nursing homes in San Antonio, Texas. They were to have more than 3 months residency; to be ⩾61 years; and to be dependent in at least 2 ADLs with an MMSE score of ⩾15. Subjects were administered a 128- item SIP and a reduced 66- item SIP- NH at baseline and 4, 8, and 12- month follow- up. At each follow- up, subjects were classified into 3 mutually exclusive change categories using a change score of ⩾5 points. Concordance of the classification of subjects by the SIP- NH and SIP was evaluated. The misclassification rate as well as its direction was also assessed. Both instruments classified a little over one- quarter of the subjects as better, over a third as being unchanged, and another third as being worse at the four- month follow- up. More subjects were classified as worse by both instruments at 8 and 12 months. All kappas ranged from 0.52 to 0.78, indicating good to excellent agreement. Overall, the SIP- NH characterized persons as changed more often than the SIP with no systematic directional bias. In conclusion, the SIP- NH was concordant with the SIP in classifying change in subjects. However, we cannot say which of the two is better for detecting change. Future research must focus on defining a change score which has clinical meaning, and evaluate responsiveness to change. (Aging Clin. Exp. Res. 7: 228–233, 1995)

OBJECTIVE: The objective of this study was to compare two methods of measuring physical function in subjects with a broad range of abilities and to evaluate the effects of cognitive, social, educational, and age factors on the relationship between the two methods. DESIGN: Multiple regression analysis was used to compare self-perceived (dependent variables) with performance measures (independent variables). Covariates included age, gender, Mini-Mental State Exam score, education, living status, and depression score. SETTING: Five community-dwelling and two nursing home sites. PARTICIPANTS: 417 community-dwelling subjects and 200 nursing home residents aged 62–98 years. MEASUREMENTS: Self-perceived physical function was assessed with the physical dimension summary score of the Sickness Impact Profile, which comprises three subscales: ambulation, mobility, and body care and movement. Physical performance was evaluated by self-selected gait speed, chairstand time, maximal grip strength, and a balance score. RESULTS: Nursing home residents and community-dwellers were significantly different (P < .0001) in all variables except age and gender. Self-perceived and performance-based measures were moderately correlated, with a range from r = −.194 to r = −.625 (P < .05). Gait speed was the strongest independent predictor of self-perceived physical function in both groups. Symptoms of depression were also an independent predictor of self-perceived function in nursing home residents; subjects who had such symptoms report more self-perceived dysfunction than would be predicted based on performance tests. CONCLUSIONS: Self-selected gait speed is a global indicator of self-perceived physical function over a broad range of abilities. External determinants (depressive symptoms, cognitive function, marital status, etc.) affect self-perceived function in both groups, but gait speed is the greatest single predictor of self-perceived function. In nursing home residents depressive symptomatology is related to self-perceived function, but gait speed is not.

In association with the publication of the summary of the NICE guidelines on dementia, the Editors discuss steps being taken at Annals of Internal Medicine to promote dissemination of high-quality ...

This is the third in a series of five articles This paper summarises the drugs available for treating patients with hypertension. It is based on a book chapter for which more than 1500 trials and systematic reviews were screened. The book chapter covers dyslipidaemia, diabetes, tobacco misuse, physical inactivity, antiplatelet treatment, alcohol consumption, and vitamin supplementation in patients with hypertension.1 #### Summary points For the initial treatment for hypertension a single agent may be appropriate or, depending on the patient's risk factors, a combination of two or more may be needed Treatment decreases risks of fatal and non-fatal stroke, cardiac events, and death and may improve quality of life Thiazide diuretics seem the best first line agents for reducing rates of stroke and death Angiotensin converting enzyme inhibitors, some β blockers, and some long acting calcium channel blockers are efficacious alternatives Short acting α antagonists should be avoided as first line agents Short acting calcium channel blockers should be avoided ### General benefits Many large randomised placebo controlled trials consistently show that antihypertensive drug treatment decreases the risk of fatal and non-fatal stroke, cardiac events, and death in men and women with systolic or diastolic hypertension,1–3 without adverse effect on quality of life, which may even be improved.4 People at greater cardiovascular risk when they start treatment, such as elderly patients with other relevant risk factors, derive the most absolute benefit from drug treatment. ### Specific antihypertensive drugs as first line agents It is not clear whether the benefits of specific antihypertensive drugs come from their direct effects on raised blood pressure or whether they act by various other multiple indirect actions. It is difficult to assess effects of particular agents, because most large trials have used a stepped care approach in which a second or third drug is added when the first choice does not reduce blood pressure …

Decision makers often rely on large, multisite observational studies to evaluate benefits and harms of therapies. Using data from Ray and colleagues' study in this issue, the editorialists discuss ...

This study was designed to evaluate long-term benefits of hearing aids in elderly individuals with hearing loss. A primary care cohort of 192 elderly, hearing-impaired veterans (mean age 72 ± 6, 97% White, 94% retired) were assessed at baseline and at 4, 8, and 12 months after hearing aid fitting. Drop-out rates at 4, 8, and 12 months were 5%, 13%, and 16%, respectively. Outcome assessments included several quality-of-life scales: Hearing Handicap Inventory in the Elderly (HHIE), Quantified Denver Scale of Communication Function (QDS), Geriatric Depression Scale (GDS), and the Short Portable Mental Status Questionnaire (SPMSQ). All quality-of-life areas improved significantly from baseline to 4-month post-hearing aid fittings ( p < 0.05). Social and emotional (HHIE), communication (QDS), and depression (GDS) benefits were sustained at 8 and 12 months, whereas cognitive changes (SPMSQ) reverted to baseline at 12 months. We conclude that hearing aids provide sustained benefits for at least a year in these elderly individuals with hearing impairment.