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Reanalysis of systematic reviews: the case of invasive strategies for acute coronary syndromes.

OBJECTIVES: The objective of this study was to collect all systematic reviews on invasive strategies for acute coronary syndromes (ACS) and reanalyze the data in these reviews to reach combined estimates, as well as to make predictions on the effectiveness and risk of harm so as to facilitate relevant decision making in health care. METHODS: The data sources used were the following electronic databases, searched from 1994 to September 2004: Cochrane Database of Systematic Reviews; Cochrane Central Register of Controlled Trials; DARE, HTA, EED (NHS CRD); MEDLINE In-Process, Other Non-Indexed Citations, MEDLINE, and PubMed (2000 to 2004). References to the identified systematic reviews were checked. An ancillary search to identify recent randomized controlled trials (RCTs) covering the period from January 2003 to January 2006 was done in MEDLINE(R). We included systematic reviews of RCTs on patients with ACS. In unstable angina and non-ST-elevation myocardial infarction (UA/NSTEMI), eligible reviews had to compare early routine invasive strategy with early selective invasive strategy. In ST-elevation myocardial infarction (STEMI), a comparison between primary percutaneous coronary intervention (PCI) and thrombolytic therapy was required. The methodological quality of the reviews was assessed, and a standardized data extraction form was used. Results for the main outcomes of the RCTs in the reviews were reanalyzed. An additional search of those RCTs not included in the meta-analyses was performed for UA/NSTEMI and short-term morality data on STEMI. Bayesian models were constructed to estimate the uncertainty about a possible treatment effect and to make predictions and probability statements. Main results are based on these analyses. Mortality was considered as the primary outcome measure. RESULTS: One systematic review on invasive strategies was identified for UA/NSTEMI and nine on invasive strategies for STEMI. Five reviews of the latter that were published after the year 2000 were included for the final analysis. The median quality score was 10.5 (range, 7-13; n = 6) on a scale from 0 to 18 points. An updated literature search identified one further RCT on UA/NSTEMI. Regarding NSTEMI and mortality, the average risk difference favoring an early invasive treatment strategy compared with early conservative strategy was .6 percent (95 percent credible interval [CrI], -2.1 to 1.0). Predicted risk (relative risk/risk difference scales) of doing harm was 26.7/26.6 percent. Regarding STEMI and mortality, the absolute risk reduction in favor of primary PCI over thrombolysis was 4.1 percent (95 percent CrI, -7.1 to -1.1) when PCI was compared with streptokinase and 1.2 percent (95 percent CrI, -2.7 to .2) when compared with fibrin-specific thrombolytics. Predicted risk of harm was 8.9/5.3 percent and 8.0/13.3 percent, respectively. CONCLUSIONS: There seems to be at present no solid evidence for survival benefit on early invasive strategy for UA/NSTEMI as a broad diagnostic group, and the risk of doing harm should be considered. Also, the evidence for PCI to decrease early mortality after STEMI is scanty. Estimations of predicted harm may further aid decisions on whether to implement the new treatment over the old one. It may also give an additional dimension for interpreting the results of any meta-analysis.

Angioplasty, Balloon, Coronary↗

Assessing the impact of abstracts from the Thoracic Society of Australia and New Zealand in Cochrane reviews.

OBJECTIVE: The aim of this study was to assess the potential impact of including trials, reported in conference abstracts from the Thoracic Society of Australia and New Zealand, in Cochrane reviews. METHODOLOGY: Abstracts from the Thoracic Society of Australia and New Zealand, published in the Australian and New Zealand Journal of Medicine (1981-1998), were read to identify all reports of randomized trials. A search was carried out of the Cochrane Database of Systematic Reviews (Issue 1, 2002) for each trial reported in a conference abstract to try to identify Cochrane reviews in which the conference abstract might be eligible for inclusion. If it was unclear, the authors of the review were contacted. RESULTS: A total of 187 reports of randomized trials were identified: 101 (54%) had been published as a full report and 86 (46%) remained unpublished. Thirty-four (72%) were reports of randomized controlled trials and 52 (28%) were quasi-randomized or possibly randomized trials. The total number of patients included in the trials was 9691; range 4-1203 (median 20; IQR 11-47). No possible Cochrane review was found for 145 of the 187 trials reported in the conference abstracts. Possible reviews were identified for 42 trials, 24 of which were already mentioned in Cochrane reviews. For the remaining 18 trials, only three were said to be eligible for inclusion. CONCLUSION: A search of conference abstracts identified a number of reports of randomized trials, potentially eligible for inclusion in reviews of health care. However, the majority of trials were not relevant for inclusion in an existing Cochrane review. This is most likely because there are currently too few reviews to deal with the topics covered in the abstracts.

Australia↗

Is quality control of Cochrane reviews in controversial areas sufficient?

OBJECTIVES: Some conclusions from the Cochrane Database of Systematic Reviews (CDSR) seem volatile in areas of controversy and have recently changed conclusions. With this perspective in mind we decided to test the validity and sensitivity of negative conclusions in a systematic review of low-level laser therapy (LLLT) for osteoarthritis (OA) from the Cochrane Library was valid and robust. SETTINGS/LOCATION: None as this was a systematic review of literature. DESIGN: Validity was tested against a 9-item checklist for systematic reviews. Review selections were analyzed for possible discrepancies between trial and review reports and omissions of relevant trials and data. Data from discrepancies and omissions were then entered into sensitivity and subgroup analyses. OUTCOME MEASURES: Continuous and dichotomous data for pain SUBJECTS: Patients with osteoarthritis. INTERVENTIONS: LLLT. RESULTS: Only clinicians who had performed LLLT trials, and had negative results were invited into the review group. The review was oblivious to findings published after 1993 about physiologic mechanisms and dose response patterns for LLLT. We found 18 questionable selections that favored a negative review conclusion in 17 of 18 cases. These were largely omissions of relevant positive data and selective inclusion of negative data from trials with small, ineffective doses. When existing and omitted data from relevant trials were combined, results changed from negative to significantly positive for continuous and categorical data. Subgrouping trials by location and recommended doses taken from current guidelines, revealed a highly significant effect of LLLT for treating knee OA. CONCLUSIONS: The results of this CDSR was not robust and seems to be colored by questionable selections or omissions. For alternative pain therapies, it should be considered if lack of expertise on therapy mechanisms, or conflicts of interests with competing pain drug manufacturers, may bias conclusions. Review groups should recruit a balanced mix of current views and expertise and expand the use of sensitivity analyses to improve quality of CDSRs in areas of controversy.

Advisory Committees↗

Reasons reviewers reject and accept manuscripts: the strengths and weaknesses in medical education reports.

PURPOSE: Scientific journals rely on peer review to maintain the high quality and standards of papers accepted for publication. The purpose of this study was to explore the strengths and weaknesses of medical education reports by analyzing the ratings and written comments given by external reviewers. METHOD: The author conducted a content analysis of reviewers' comments on 151 research manuscripts submitted to the 1997 and 1998 Research in Medical Education conference proceedings. The negative comments on 123 manuscripts that received "questionable, probably exclude" or "definitely exclude" overall ratings from at least one reviewer were evaluated. A similar analysis was performed on reviewers' positive comments for 28 manuscripts recommended unanimously for acceptance. RESULTS: On average, four peers (4.1, SD = 0.97, range = 2-6) reviewed each manuscript. Of those recommended for exclusion, a mean of 2.3 reviewers recommended exclusion and each reviewer wrote a mean of 8.1 (SD = 5.7) reasons. The top ten reasons for rejection were: inappropriate or incomplete statistics; overinterpretation of results; inappropriate or suboptimal instrumentation; sample too small or biased; text difficult to follow; insufficient problem statement; inaccurate or inconsistent data reported; incomplete, inaccurate, or outdated review of the literature; insufficient data presented; and defective tables or figures. The main strengths noted in accepted manuscripts were the importance or timeliness of the problem studies, excellence of writing, and soundness of study design. CONCLUSION: While overstating the results and applying the wrong statistics can be fixed, other problems that the reviewers identified (ignoring the literature, designing poor studies, choosing inappropriate instruments, and writing poor manuscripts) are likely to be fatal flaws warranting rejection.

Curriculum↗

Preparticipation evaluation: an evidence-based review.

OBJECTIVE: To review available evidence establishing the validity of the preparticipation evaluation (PPE) as a method for screening health risk prior to participation in exercise and sport. Specific emphasis was placed on reviewing original research evaluating methods to screen participants for risk of sudden cardiovascular death. Literature on the current state of the PPE as a screening tool for athletic participation was examined. DATA SOURCES: Electronic databases were searched for articles relating to mass screening for sports participation and sudden cardiac death in athletes published up to January 2004. Databases searched included Medline (OVID Web, 1966-2004), PubMed (1966-2004), Sport Discuss (1975-2004), Current Contents, CISTI Source (1993-2004), Cochrane Database of Systematic Reviews, and EBM Reviews. Additional references from the bibliographies of retrieved articles were also reviewed. SELECTION CRITERIA: All study designs were retrieved, but only those studying athletes and/or student-athletes under age 36 years were reviewed. Of the original research retrieved, the majority of the articles sought to establish incidence or prevalence of cardiovascular causes of sudden death in athletes or the validity of various screening tools. Original research articles seeking to establish the current use of the PPE in all its various forms were also reviewed. All of the articles selected for review consisted of type II, population-based data. DATA EXTRACTION AND SYNTHESIS: The initial literature search identified 639 papers. Of these, 310 articles that met the selection criteria were reviewed, and 25 articles were identified as original research directly relating to the PPE. All of these contained type II evidence-population-based clinical studies. The majority of the literature on the PPE consists of type III evidence-case-based opinion papers and position papers from respected authors and sports medicine societies and reports of expert committees. This literature was also reviewed, but only original research relevant to the PPE is reported in this article. The majority of these studies examined cardiovascular diseases and screening procedures. RESULTS: The 5 studies that assessed the format or effectiveness of the PPE concluded that it was inadequate. The format of the PPE is not standardized and does not consistently address the American Heart Association recommendations for cardiovascular screening history and physical exams. A variety of health care professionals, some without proper training, administer the PPE. The 12 original studies that looked at specific cardiovascular screening techniques were divided on the effectiveness of history, physical examination, electrocardiogram, and echocardiography for detecting cardiovascular risks for sudden death in athletes. CONCLUSIONS: A PPE is required by most sport organizations in America, but research as to its effectiveness is very limited. PPEs have been mandatory in Italy for many years, and we can draw on some the data recorded over this time. Otherwise, very few studies in America or elsewhere have been performed on the PPE process. The research available indicates that the PPE is not implemented adequately or uniformly. An opportunity exists to create a standardized, validated PPE that meets medical standards for quality and provides sensitive, specific screening of potential participants in sport and exercise.

Athletic Injuries↗

Quality assessment of reviewers' reports using a simple instrument.

OBJECTIVE: To validate and test a simple instrument for assessing the quality of a review. METHODS: In this prospective observational study, the quality of 247 reviews of 119 original articles submitted to the Dutch Journal of Medicine was assessed using a 5-point scale that has been used for years by Obstetrics & Gynecology. Each review was assessed by three editors of the journal. Intraobserver variability, calculated as an intraclass correlation coefficient, was assessed by having the same editors rate 76 reviews for a second time. Validation of the scale was done in two ways. First, editors of three other medical journals were asked to rate the 247 reviews using the same 5-point scale. Second, all reviews were sent to the authors of the article with a questionnaire consisting of 12 yes-or-no questions and one question asking for an overall score for the review. RESULTS: The interobserver intraclass correlation coefficient for the three editors was 0.62 (95% confidence interval 0.50-0.71) for the first assessment of 247 reviews. For the second assessment of 76 reviews, the interobserver intraclass correlation coefficient was 0.62 (0.45-0.74). The intraobserver intraclass correlation coefficient for each of the internal editors ranged from 0.66 to 0.88. The interobserver intraclass correlation coefficient for the external editors was 0.60 (0.51-0.68). The interobserver intraclass correlation coefficient for all six editors was 0.62 (0.55-0.68). The authors' response rate to the questionnaires was 83%. A significant correlation was found between the mean total editorial quality assessment and the overall score of the authors (intraclass correlation coefficient 0.28, 0.14-0.41). CONCLUSION: This 5-point scale proved to be a simple, reliable, and valid instrument enabling editors to assess the quality of reviews. A significant correlation was found between mean editorial quality assessment and the quality as determined by authors. LEVEL OF EVIDENCE: III.

Humans↗

Development of a case report review instrument.

Case reports are valued components of the medical literature. The assessment of case reports by editors of medical journals and peer reviewers is largely subjective. The purpose of this study was to develop a reliable instrument to evaluate the quality of written case reports. Instrument development involved review of the literature and the materials provided to peer reviewers who review manuscripts, communications with journal editors and discussions of the study team. After multiple amendments, the instrument was pilot tested on both published and unpublished case reports. Further revisions resulted in the final 11-item tool. Four independent reviewers evaluated 28 case reports in their original submission format that had been submitted to five medical journals. The reviewers were blinded to the specific journal that the manuscripts had been submitted and to whether the case reports had been accepted for publication. Inter-rater reliability was assessed using multirater kappa. Inter-rater reliability ranged from 0.03 to 0.90. The four variables with the highest agreement between raters were (i) rationale for writing the case report; (ii) implications of the case report; (iii) adequacy of the literature review; and (iv) overall impression about whether to accept or reject the manuscript (kappas of 0.67, 0.67, 0.90 and 0.67, respectively). Six of the instrument's first 10 variables were highly correlated with the reviewers' decision about whether to accept or reject the case report for publication (item 11) (all p < 0.001). No correlation existed between the reviewers' decision to accept or reject the manuscript and the actual decision that had been made by the various journals. The case report review instrument is the first such tool for objectively evaluating case reports and appears to have reasonable reliability. Medical journals may wish to incorporate the use of this instrument into the decision making about a case report's suitability for publication.

Humans↗

What's the basis for treating infections your way? Quality assessment of review articles on the treatment of urinary and respiratory tract infections in older people.

OBJECTIVE: To assess the quality of readily available review articles on urinary and respiratory tract infections in older people. METHODS: Data sources were articles identified by MEDLINE search (1988-1998), review of the bibliographies of identified publications, textbooks from the library of a geriatric university hospital, and booklets with general guidelines on antibiotic therapy. Selection was made of review articles or book chapters about urinary and/or respiratory tract infections in older people that were readily available, ie, in Swiss medical libraries. Quality was assessed according to clinical applicability of the recommendations, methodology of the review, type of literature cited in the bibliography, and age of the population included in these reference articles. RESULTS: Only 13 of 29 (45%) review articles about urinary tract infections and seven of 29 (24%) articles about respiratory tract infections satisfied our criteria of applicability. Specifically, dosage, route of administration, and treatment duration were often not described. The overall methodological quality was low (mean score 1.9 +/- 1.0 on a scale of 9). No review specified the methods used to identify, select, and validate included information. Authors of the review articles quoted an important number of other review articles and only a small number of clinical trials. Less than one-quarter of these clinical trials actually comprised primarily an older population. CONCLUSIONS: Review articles on treatment of common infectious diseases in older people are often neither clinically applicable nor of good methodological quality. Therefore, more systematic review articles regarding treatment of older patients, as well as evidence-based practice guidelines, are needed.

Geriatrics↗

Evidence review on older people's views and experiences of falls prevention strategies.

BACKGROUND: A systematic review was undertaken of qualitative and quantitative studies and reviews that focus on older people's views and experiences of falls prevention. The review was undertaken to provide an additional dimension to the clinical effectiveness evidence provided by a Cochrane review on falls prevention (Gillespie et al. 2003) to inform the development of a national guideline on falls prevention in older people. As guideline recommendations or policies relating to preventive strategies have the potential to increase health care costs, it is important that all sources of evidence are reviewed by guideline development groups so that an understanding is achieved of the acceptability and sustainability of interventions in relation to different groups and settings. METHOD: Accordingly, this review examined the literature on the views, preferences, and experiences of older people in relation to falls prevention strategies. Twenty-four studies meeting the inclusion criteria were critically reviewed and were then summarized into evidence tables. The key facilitators and barriers to participation in falls prevention programs were derived from the commonly occurring and consistent themes arising from the reviewed studies. The implications of these findings for the clinical effectiveness review conclusions were then taken into account. FINDINGS: Several important findings emerged. These included preferences for falls prevention strategies not involving behaviour change among some groups, the need to promote the social value of falls prevention programs, and the importance of identifying and addressing factors associated with activity avoidance. CONCLUSIONS AND IMPLICATIONS: In terms of the impact of these findings on the Cochrane review, the most important implication is that although trials of multifactorial falls prevention packages have reported beneficial results, in clinical practice it is important to consult with individual potential participants and find out what characteristics they are willing to modify, and what changes they are prepared to make to reduce their risk of falling. Otherwise, there is the risk that expensive programs are not properly targeted or fail to achieve maximum participation rates. Further work on the most robust and pragmatic methods of synthesizing disparate studies on patients' views and preferences to inform evidence-based guideline recommendations is needed.

Accident Prevention↗

What happened to the valid POEMs? A survey of review articles on the treatment of type 2 diabetes.

OBJECTIVE: To evaluate systematically the review literature on type 2 diabetes to assess transmission of the findings of the United Kingdom prospective diabetes study (UKPDS), an important source of recent valid patient oriented evidence that matters (POEMs). DESIGN: Inception cohort analysis of the recent medical literature. STUDIES REVIEWED: Thirty five reviews on treatment of type 2 diabetes. MAIN OUTCOME MEASURES: Presentation of three types of information from UKPDS in review articles: recommendations based on patient oriented outcomes of study; recommendations contradicted by patient oriented outcomes of study; and recommendations based on disease oriented outcomes for which no patient oriented evidence exists. RESULTS: Only six of the reviews included the POEM that tight blood glucose control had no effect on diabetes related or overall mortality. Just seven mentioned that metformin treatment was associated with decreased mortality. Most (30) of the reviews did not report that diabetic patients with hypertension benefit more from good blood pressure control than good blood glucose control. No review pointed out that treatment of overweight patients with type 2 diabetes with insulin or sulphonylurea drugs had no effect on microvascular or macrovascular outcomes. Thirteen reviews recommended drugs as first line treatment for which we do not have patient oriented outcomes data. The average validity assessment score was 1.3 out of a possible score of 15 (95% confidence interval 0.9 to 1.8). CONCLUSIONS: Review articles on the treatment of type 2 diabetes have not accurately transmitted the valid POEM results of the UKPDS to clinicians. Clinicians relying on review articles written by experts as a source of valid POEMs may be misled.

Blood Glucose↗

Application of meta-analysis in reviewing occupational cohort studies.

Meta-analysis has been used increasingly in reviewing and summarising epidemiological studies. Reviews incorporating meta-analyses have appeared in medical journals in increasing numbers. Although there are several methodology papers on meta-analysis, most of these papers have been written primarily for discussion among epidemiologists. The present paper considers some of the basic methodological issues, the more practical aspects of meta-analysis, and targets an audience of mainly non-epidemiologists. Thus, the main objective of this paper is to provide some basic guidelines for non-epidemiologists to evaluate meta-analysis in occupational cohort studies. In this methodology paper, the limitations and problems of traditional qualitative reviews are pointed out. Some of these problems can be dealt with by quantitative meta-analysis. The potential limitations and benefits of quantitative meta-analysis are discussed. Rather than replacing traditional qualitative review, quantitative meta-analysis should be made part of the overall assessment. The term "meta-review" is proposed to emphasise the importance of both qualitative and quantitative components in a comprehensive review process. The basic steps in a meta-review are outlined, with a discussion on how to recognise and avoid some of the problems which are likely to occur at each step. A meta-review is useful in selecting studies, and in organising, presenting, and summarising results from individual studies. A meta-review can also be used to detect heterogeneity among studies. Major benefits of conducting a meta-analysis (the quantitative component in a meta-review) include the increase in statistical power and the estimate of a properly weighted summary risk estimate.

Brain Neoplasms↗

Developing a cooperative provider-based statewide peer review service: early experience.

The purpose of this study was to demonstrate the feasibility of a model of overcoming local barriers to physician peer review through development of a statewide provider-based physician peer review service. For this purpose, the cooperative demonstration project of the Institute for Quality Healthcare, The University of Iowa and The Robert Wood Johnson Foundation, was used. A consortium of 43 Iowa hospitals developed a physician peer review service utilizing a pool of physician reviewers from member hospitals. Thirty-six peer reviews were conducted in 23 different hospitals by 37 different reviewers throughout the state of Iowa in the first 2 years of operation. Reviews of surgical specialists, psychiatrists, and psychiatric services were requested most frequently. The satisfaction of hospitals with the physician peer review service has thus far been gratifying. The long-term financial viability of the physician peer review service has yet to be demonstrated. This cooperative organizational model of a provider-based physician peer review service may be reproducible and valuable to health care providers in other parts of the United States.

Academies and Institutes↗

Assessing the quality of reports of systematic reviews in pediatric complementary and alternative medicine.

OBJECTIVE: To examine the quality of reports of complementary and alternative medicine (CAM) systematic reviews in the pediatric population. We also examined whether there were differences in the quality of reports of a subset of CAM reviews compared to reviews using conventional interventions. METHODS: We assessed the quality of reports of 47 CAM systematic reviews and 19 reviews evaluating a conventional intervention. The quality of each report was assessed using a validated 10-point scale. RESULTS: Authors were particularly good at reporting: eligibility criteria for including primary studies, combining the primary studies for quantitative analysis appropriately, and basing their conclusions on the data included in the review. Reviewers were weak in reporting: how they avoided bias in the selection of primary studies, and how they evaluated the validity of the primary studies. Overall the reports achieved 43% (median = 3) of their maximum possible total score. The overall quality of reporting was similar for CAM reviews and conventional therapy ones. CONCLUSIONS: Evidence based health care continues to make important contributions to the well being of children. To ensure the pediatric community can maximize the potential use of these interventions, it is important to ensure that systematic reviews are conducted and reported at the highest possible quality. Such reviews will be of benefit to a broad spectrum of interested stakeholders.

Age Distribution↗

The use of systematic reviews when designing studies.

BACKGROUND: The importance of systematic reviews in identifying gaps in the evidence base and providing a quantitative basis for informing new research initiatives is widely acknowledged, but little is known about what actually happens in practice. Our objective was to assess the use made of results of reviews in the designing of new studies. METHODS: Of all Cochrane reviews published in 1996, those updated in 2002 or 2003 were identified. Authors of trials added in the updates were contacted and asked if use had been made of the 1996 Cochrane or other reviews in designing their study. RESULTS: Of 32 authors of studies newly included in 33 Cochrane reviews which met our inclusion criteria, 24 (75%) responded. Eleven (46%) respondents were aware of the relevant Cochrane review at the time they designed their study. In eight (33%) cases the design of the new study had been influenced by a review; in two (8%) this was the relevant Cochrane review. CONCLUSIONS: Cautious interpretation of these results is necessary, but it is apparent that the proportion of study investigators using Cochrane or other systematic reviews in designing their new studies was very limited. Inclusion of encouragement in publication or application guidelines to consider and cite review results is desirable.

Clinical Trials as Topic↗

Developing and evaluating criteria to help reviewers of biomedical informatics manuscripts.

Peer-reviewed publication of scientific research results represents the most important means of their communication. The authors have annually reviewed a large heterogeneous set of papers to produce the International Medical Informatics Association (IMIA) Yearbook of Medical Informatics. To support an objective and high-quality review process, the authors attempted to provide reviewers with a set of refined quality criteria, comprised of 80 general criteria and an additional 60 criteria for specific types of manuscripts. Authors conducted a randomized controlled trial, with 18 reviewers, to evaluate application of the refined criteria on review outcomes. Whereas the trial found that reviewers applying the criteria graded papers more strictly (lower overall scores), and that junior reviewers appreciated the availability of the criteria, there was no overall change in the interrater variability in reviewing the manuscripts. The authors describe their experience as a "case report" and provide a reference to the refined quality review criteria without claiming that the criteria represent a validated instrument for quantitative quality measurement.

Humans↗

Peer review checklist: reproducibility and validity of a method for evaluating the quality of ambulatory care.

This report describes the construction and evaluation fo a 35-item checklist used in performing peer review of ambulatory medical records. Scores obtained by using the checklist were evaluated for reproducibility. Ten reviewers, reviewing ten records on each of two occasions judged the records consistently item by item, 74 per cent of the time; 53 per cent greater than expected by chance (p less than 0.01). Pairs of reviewers, reviewing the same ten records, were consistent with one another, item by item, 72 per cent of the time; 35 per cent greater than expected by chance (p less than 0.05). Ten sick call patients were reexamined by an especially trained Reevaluation Physician who evaluated the quality with which they had been managed at the time of sick call. The medical records of the same ten patients were then reviewed with the Peer Review Checklist. The correlation between the quality scores obtained by the two methods were 0.72 and 0.74 on two trials. A correlation coefficient of 0.44 was found between the two evaluation methods when 89 cases were reviewed by a Peer Review panel composed of 10 different physicians. Peer Review Checklist scores correlated positively with scores obtained by using a series of disease specific protocols with explicit criteria. The correlations varied from 0.28 to 0.63 with six different disease specific protocols.

Ambulatory Care↗

Outcomes of National Institutes of Health peer review of clinical grant applications.

PURPOSE: We previously reported that National Institutes of Health (NIH) peer review outcomes in 2002 were slightly but significantly less favorable for grant applications for clinical research than for laboratory research. The present analysis was undertaken to determine if factors related to the review process might contribute to this difference. METHODS: The impact of each of the following factors on median priority scores and funding rates for clinical and nonclinical R01 grant applications was evaluated: (1) the percentage of clinical applications assigned for review to a study section, (2) the requested direct costs, and (3) the clinical research experience of the reviewers. RESULTS: Confirming our previous observation, in both 1994 and 2004, median priority scores and funding rates for R01 applications were less favorable for clinical research. In 1994, clinical applications did not fare as well in study sections reviewing relatively low percentages of clinical applications. This was not the case in 2004. Although requested direct costs were greater for clinical than for nonclinical R01 applications, median priority scores within each category were actually more favorable for applications requesting greater funding. Assignment of priority scores was not different for reviewers with or without experience conducting clinical research. CONCLUSION: These data do not support the hypothesis that the less favorable review outcomes for clinical applications are related to these review factors. We suggest that peer review outcomes for clinical research will benefit from the recent refinement of NIH review criteria, emphasizing the unique contributions of clinical investigation, and from increased training opportunities for clinical investigators.

Biomedical Research↗

Systematic reviews of the effectiveness of day care for people with severe mental disorders: (1) acute day hospital versus admission; (2) vocational rehabilitation; (3) day hospital versus outpatient care.

UNLABELLED: ***ACUTE DAY HOSPITAL VERSUS ADMISSION FOR ACUTE PSYCHIATRIC DISORDERS*** BACKGROUND: Inpatient treatment is an expensive way of caring for people with acute psychiatric disorders. It has been proposed that many of those currently treated as inpatients could be cared for in acute psychiatric day hospitals. OBJECTIVE: The aim of this review was to assess the effectiveness and feasibility of day hospital versus inpatient care for people with acute psychiatric disorders. METHODS - STUDY SELECTION: Eligible studies were randomised controlled trials of day hospital versus inpatient care for people with acute psychiatric disorders. Studies were excluded if they were primarily concerned with elderly people, children, or patients with a diagnosis of organic brain disease or substance abuse. METHODS - DATA SOURCES: We searched the Cochrane Controlled Trials Register, MEDLINE, EMBASE, CINAHL, PsycLIT, and the reference lists of articles. Researchers were approached to identify unpublished studies. Trialists were asked to provide individual patient data. METHODS - DATA EXTRACTION: Data were extracted independently by two reviewers and cross-checked. METHODS - DATA SYNTHESIS: Relative risk (RR) and 95% confidence intervals (CIs) were calculated for dichotomous data. Weighted or standardised means were calculated for continuous data. Day hospital trials tend to present similar outcomes in slightly different formats, making it difficult to synthesise the data. Individual patient data were therefore sought so that outcomes could be re-analysed using a common format. RESULTS: Nine trials met the inclusion criteria (involving 1568 randomised patients and 2268 assessed for suitability of day hospital treatment). Individual patient data were obtained for four trials (involving 594 people). A sensitivity analysis of combined data suggested that day hospital treatment was feasible for at worst 23.2% (n = 2268; 95% CI, 21.2 to 25.2) and at best 37.5% (n = 1768; 95% CI, 35.2 to 39.8) of those currently admitted to inpatient care. Individual patient data from three trials showed no difference in the number of days in hospital (combining day hospital days and inpatient days) between day hospital patients and controls (n = 465; weighted mean difference (WMD) = -0.38 days/ month; 95% CI, -1.32 to 0.55). However, compared with controls, patients randomised to day hospital care spent significantly more days in day hospital care (n = 265; WMD = 2.34 days/month; 95% CI, 1.97 to 2.70) and significantly fewer days in inpatient care (n = 265; WMD = -2.75 days/month; 95% CI, -3.63 to -1.87). There was no difference between readmission rates for day hospital and control patients (n = 667; RR = 0.91; 95% CI, 0.72 to 1.15). Individual patient data from three trials showed a significant time-treatment interaction, indicating a more rapid improvement in mental state (n = 407; c2 = 9.66; p = 0.002), but not social functioning (n = 295; c2 = 0.006; p = 0.941) amongst day hospital patients. Four of five trials demonstrated that day hospital care was cheaper than inpatient care (with overall cost reductions ranging from 20.9% to 36.9%). CONCLUSIONS: Acute day hospitals are an attractive option in situations where demand for inpatient care is high and facilities exist that are suitable for conversion. They are a less attractive option when demand for inpatient care is low and where effective alternatives already exist. The interpretation of day hospital research would be enhanced if future trials made use of the common set of outcome measures used in this review. It is important to examine how acute day hospital care can be most effectively integrated into a modern community-based psychiatric service. ***VOCATIONAL REHABILITATION FOR PEOPLE WITH SEVERE MENTAL DISORDERS*** BACKGROUND: People who are disabled by severe mental disorders experience high rates of unemployment, but most want to work. Prevocational training (PVT) is the traditional approach to helping such people to return to work. PVT assumes that a period of preparation is required before those with a severe mental disorder can enter into competitive employment. Supported Employment (SEm) is a new approach that places clients in competitive employment without extended preparation. Both PVT and SEm are widely practised, but it is unclear which is the most effective. OBJECTIVES: The overall objective of this review was to assess the effectiveness of PVT and SEm relative to each other and to standard care (in hospital or the community) for people with severe mental disorders. In addition, the review examined the effectiveness of: (1) special types of PVT ("clubhouse" model) and SEm (individual placement and support model); and (2) modifications for enhancing PVT (e.g. payment or psychological interventions). METHODS - STUDY SELECTION: Eligible studies were randomised controlled trials (RCTs) examining the effectiveness of vocational rehabilitation approaches (PVT and SEm or modifications) for people of working age and suffering from a severe mental disorder. METHODS - DATA SOURCES: Relevant trials were identified from searches of the Cochrane Schizophrenia Group's specialised register, MEDLINE, EMBASE, CINAHL and PsycLIT, and the reference lists of all identified studies and review articles. Researchers who were active in the field were approached in order to identify unpublished studies. METHODS - DATA EXTRACTION: All data were extracted independently by two reviewers and cross-checked. Continuous data were excluded if they were collected by using an unpublished scale or were based on a subset of items from a scale. METHODS - DATA SYNTHESIS: For all comparisons, the primary outcome was the number of clients who were in competitive employment at various time points. Secondary outcomes were: other employment outcomes, clinical outcome and costs. The relative risk (RR) and number-needed-to-treat (NNT) were calculated for the relevant categorical outcomes. Continuous data were either presented as in the original trial reports or, where possible, combined across trials as a standardised mean difference score. RESULTS: Eighteen RCTs of reasonable quality were identified: PVT versus hospital controls, three RCTs, n = 172; PVT versus community controls, five RCTs, n = 1204; modified PVT, four RCTs, n = 423; SEm versus community controls, one RCT, n = 256; and SEm versus PVT, five RCTs, n = 491). The main finding was that, on the primary outcome (number in competitive employment), SEm was significantly more effective than PVT at all time points (e.g. at 12 months, SEm 34% employed, PVT 12% employed; RR of not being in competitive employment = 0.76, 95% confidence interval 0.69 to 0.84, NNT = 4.5). Clients in SEm also earned more and worked more hours per month than those in PVT. CONCLUSIONS: The main finding was that SEm was more effective than PVT for patients suffering from a severe mental disorder who wanted to work. There was no evidence that PVT was more effective than standard community care or hospital care. The implication of these findings is that people suffering from mental disorders who want to work should be offered the option of SEm. Commissioning agencies would be justified in encouraging vocational rehabilitation (VR) providers to develop more SEm schemes. From a research perspective, the cost-effectiveness of SEm should be examined in larger multicentre trials, both within and outside the USA. There is a case for countries outside the USA to survey their existing VR services to determine the extent to which the most effective interventions are being offered. ***DAY HOSPITAL VERSUS OUTPATIENT CARE FOR PATIENTS WITH PSYCHIATRIC DISORDERS*** BACKGROUND: This review considers the use of day hospitals as an alternative to outpatient care. Two typesof day hospital provision are covered: "day treatment programmes" and "day care centres". Day treatment programmes are day hospitals that are used to enhance the treatment of patients with anxiety or depressive disorders who have failed to respond to outpatient care. Day care centres are day hospitals that offer structured support to patients with long-term severe mental disorders who would otherwise be treated in an outpatient clinic. OBJECTIVES: There were two objectives: first, to assess the effectiveness of day treatment programmes versus outpatient care for people with non-psychotic disorders; and, secondly, to assess the effectiveness of day care centres versus outpatient care for people with severe long-term disorders. METHODS - STUDY SELECTION: Eligible studies were randomised controlled trials comparing day hospital care (either a day treatment programme or a day care centre) with outpatient care. Studies were ineligible if they were largely restricted to patients who were aged under 18 or over 65 years or who had a primary diagnosis of substance abuse or organic brain disorder. METHODS - DATA SOURCES: Relevant trials were identified from searches of the Cochrane Controlled Trials Register, MEDLINE, EMBASE, CINAHL, PsycLIT, and the reference lists of all identified studies and review articles. Researchers were approached to identify unpublished studies. Trialists were asked to provide individual patient data. METHODS - DATA EXTRACTION: All data were extracted independently by two reviewers and cross-checked. METHODS - DATA SYNTHESIS: Relative risks and 95% confidence intervals were calculated for dichotomous data. Standardised mean differences were calculated for continuous data. RESULTS: There was evidence from two of the five trials identified suggesting that day treatment programmes were superior to continuing outpatient care in terms of improving psychiatric symptoms. There was no evidence to suggest that day treatment programmes were better or worse than outpatient care on any other clinical or social outcome variable or on costs. (ABSTRACT TRUNCATED)

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