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PubMed2002

How to write an evidence-based clinical review article.

Traditional clinical review articles, also known as updates, differ from systematic reviews and meta-analyses. Updates selectively review the medical literature while discussing a topic broadly. Non-quantitative systematic reviews comprehensively examine the medical literature, seeking to identify and synthesize all relevant information to formulate the best approach to diagnosis or treatment. Meta-analyses (quantitative systematic reviews) seek to answer a focused clinical question, using rigorous statistical analysis of pooled research studies. This article presents guidelines for writing an evidence-based clinical review article for American Family Physician. First, the topic should be of common interest and relevance to family practice. Include a table of the continuing medical education objectives of the review. State how the literature search was done and include several sources of evidence-based reviews, such as the Cochrane Collaboration, BMJ's Clinical Evidence, or the InfoRetriever Web site. Where possible, use evidence based on clinical outcomes relating to morbidity, mortality, or quality of life, and studies of primary care populations. In articles submitted to American Family Physician, rate the level of evidence for key recommendations according to the following scale: level A (randomized controlled trial [RCT], meta-analysis); level B (other evidence); level C (consensus/expert opinion). Finally, provide a table of key summary points.

Evidence-Based Medicine↗
PubMed2001

Evidence-based practice: extending the search to find material for the systematic review.

BACKGROUND: Cochrane-style systematic reviews increasingly require the participation of librarians. Guidelines on the appropriate search strategy to use for systematic reviews have been proposed. However, research evidence supporting these recommendations is limited. OBJECTIVE: This study investigates the effectiveness of various systematic search methods used to uncover randomized controlled trials (RCTs) for systematic reviews. Effectiveness is defined as the proportion of relevant material uncovered for the systematic review using extended systematic review search methods. The following extended systematic search methods are evaluated: searching subject-specific or specialized databases (including trial registries), hand searching, scanning reference lists, and communicating personally. METHODS: Two systematic review projects were prospectively monitored regarding the method used to identify items as well as the type of items retrieved. The proportion of RCTs identified by each systematic search method was calculated. RESULTS: The extended systematic search methods uncovered 29.2% of all items retrieved for the systematic reviews. The search of specialized databases was the most effective method, followed by scanning of reference lists, communicating personally, and hand searching. Although the number of items identified through hand searching was small, these unique items would otherwise have been missed. CONCLUSIONS: Extended systematic search methods are effective tools for uncovering material for the systematic review. The quality of the items uncovered has yet to be assessed and will be key in evaluating the value of the systematic search methods.

Humans↗
PubMed2002

Methodology to improve data quality from chart review in the managed care setting.

BACKGROUND: Because inherent variability may exist in data collected by multiple reviewers or from potential difficulties with data abstraction tools, we developed a standardized method of evaluating interrater reliability (IRR) for clinical studies, HEDIS effectiveness of care measures, and onsite/medical record reviews. OBJECTIVE: To demonstrate the ability of our standardized methods of data collection and analysis of results to determine the extent of agreement between multiple reviewers; identify areas for improvement in data collection procedures; and improve data reliability. STUDY DESIGN: A prospective chart review with concurrent IRR. METHODS: A subsample of patient records included in the Highmark Blue Cross Blue Shield/Keystone Health Plan West basic medical review for each HEDIS measure was selected for the IRR study. An experienced nurse ("gold standard") conducted a blinded concurrent review of these records. Using the kappa statistic (kappa) we evaluated interobserver agreement between results of the onsite reviewers and the "gold standard" from 1997 through 2000. Revised data collection methods and enhanced reviewer training were incorporated for measures showing areas for rater improvement. RESULTS: Results across years showed excellent IRR for most measures; however, each year 1 or 2 measures showed areas for rater improvement (1997 Papanicolaou kappa = 0.50; 1998 well-child visits 3 to 6 years kappa = 0.37; 1999 comprehensive diabetes kappa = 0.73; high blood pressure kappa = 0.73). After reevaluating these measures, the results of the kappa showed excellent interrater agreement in subsequent years. CONCLUSIONS: Standardized methods of data collection and evaluation of IRR results provides health plans increased confidence in data collection, statistical analyses, and in reaching conclusions and deriving relevant recommendations.

Blue Cross Blue Shield Insurance Plans↗
PubMed2003

[Increased number of systematic reviews in the Netherlands in the period 1991-2000].

OBJECTIVE: To survey systematic reviews (SRs) as publication type in the Netherlands, with emphasis on differences between Cochrane reviews and SRs in printed journals. DESIGN: Bibliometric study. METHOD: A systematic search was carried out in Medline, EMBASE and the Cochrane Library for published systematic reviews of Dutch origin in the period 1991-2000. For each SR, the year of publication, the number of original articles included, the subject matter and the impact factor of the journal were identified. RESULTS: A total of 289 SRs were retrieved, of which 12% were Cochrane reviews. The number of SRs increased exponentially during this decade. The majority (56%) of the SRs concerned a therapeutic intervention. SRs were published in journals with a moderate to good impact factor (median impact factor 2.59). On average, compared to SRs published in the Cochrane Library, the SRs published in the general medical literature included significantly more original articles (28.8 versus 13.7; p < 0.05). This may be caused by the fact that the clinical questions for Cochrane reviews are more focused as compared with non-Cochrane SRs or by the fact that Cochrane review groups may have more stringent quality requirements for inclusion of an article in a review. CONCLUSIONS: The SR as a publication type showed a rapid growth in one decade and was published in important medical journals. Cochrane reviews represented a substantial proportion of the overall number of SRs in the Netherlands.

Bibliometrics↗
PubMed1992

Prospective physician review of orders for colony-stimulating factors.

A program is described in which physicians prospectively review orders for the use of colony-stimulating factors (CSFs) at a tertiary-care private teaching hospital. Hospital officers and administrators and the heads of medical subspecialties were presented with three options for managing the use of CSFs. Prospective review by physicians was selected, and a task force of medical subspecialists was established to develop criteria for use and to review orders. Initially, every order was prospectively reviewed, but criteria were developed under which some orders do not require physician review. CSF use is documented retrospectively by a drug-use evaluation pharmacist and reviewed for appropriateness by the physician task force. Between March and October 1991, 115 patients were given courses of CSFs, and the use of the physician review system resulted in appropriate use of the drugs for 98% of the oncology patients and 61% of the patients infected with the human immunodeficiency virus. The prospective physician reviewer system has been accepted by the medical staff at the facility and has helped to ensure appropriate use of CSFs.

Colony-Stimulating Factors↗
PubMed2005

Scope for improvement in the quality of reporting of systematic reviews. From the Cochrane Musculoskeletal Group.

OBJECTIVE: To assess the quality of reporting in Cochrane musculoskeletal systematic reviews (excluding back and injury reviews). METHODS: This study assessed all the Cochrane Musculoskeletal Group's systematic reviews from Issue 4, 2002, of the Cochrane Library Database of Systematic Reviews. Two reviewers independently extracted data and assessed quality. Two assessment tools were used, including an 18 item checklist and flow chart developed by the Quality of Reporting of Meta-analysis (QUOROM) consensus group, and a 10 item scale, the Oxman-Guyatt Overview Quality Assessment Questionnaire (OQAQ). One question on the latter scale (item 10) scores overall quality on a 7 point scale, with high scores indicating superior quality. Data were analyzed using univariate approaches. RESULTS: The 57 systematic reviews assessed were found to have good overall quality, with scores on individual items revealing only minor flaws. Documenting the flow of included and excluded studies and summarizing the results are 2 areas needing improvement in reporting. According to the Oxman-Guyatt scale the overall scientific quality of the Cochrane musculoskeletal reviews was good [mean 5.02 (95% CI 3.71-6.32)]. CONCLUSION: Our study found that the reporting quality of Cochrane musculoskeletal systematic reviews was generally good, although there was room for improvement. For example, it might be feasible to develop specific guidelines for reporting protocols. Certainly more work is needed in reporting search results, documentation of the flow of studies, identification of the type of studies, and summarization of the key findings.

Evidence-Based Medicine↗
PubMed2006

Perspectives: an international review of the national cost estimates of mental illness, 1990-2003.

BACKGROUND: Mental illness is a major group of disorder that can lead to both physical and emotional disability. Policymakers need to learn not only the epidemiological indicators of mental illness, such as prevalence rate and incidence rate, but also the size of its negative impact on the economy. AIMS OF THE STUDY: This study is to review international publications on cost of major mental illness literature, from 1990 to 2003, focusing on the concepts, methods, and future perspective of cost illness studies. Reviewing the status quo on costs of mental illness can provide further information about gaps, limitations, and future needs on this topic. METHOD: This review searched all major international journals in psychiatry, clinical psychology, health economics, and mental health policy published since 1990. All national or aggregate cost of mental illness studies were included in the review. All were individually reviewed using a conceptual framework of cost of illness methodology. RESULTS: A large majority of published cost of mental illness studies were conducted in the US and UK. Cost of illness studies were lacking from Africa, Asia, Eastern Europe, and Latin America. Empirical results from the reviewed studies indicate that the negative economic consequences of mental illness far exceed the direct costs of treatment, thus making it important to treat mental illness. Direct treatment costs for each mental disorder (i.e. depression, schizophrenia, dementia, etc.) is between 1% and 2% of total national health care costs. DISCUSSION: The studies reviewed indicate great variation in cost estimates even for the same mental disorder during the same time period within a country. These wide variations may be due to differences in disorder classification, definition of cost categories, sample populations, data sources, and discounting rate. Given the limitations of the cost of illness studies reviewed, one should be careful in interpreting and using these estimated results. IMPLICATIONS FOR HEALTH SERVICES: These cost studies can be useful for understanding the magnitude of treating an illness of economic consequences or economic consequences of an illness for purposes of planning or budgeting. Such studies are one way to inform policymakers about economic consequences of mental illness.

Australia↗
PubMed2006

Method guidelines for Cochrane Musculoskeletal Group systematic reviews.

The Cochrane Musculoskeletal Group (CMSG), one of 50 groups of the not-for-profit international Cochrane Collaboration, prepares, maintains, and disseminates systematic reviews of treatments for musculoskeletal diseases. To enhance the quality and usability of systematic reviews, the CMSG has developed tailored methodological guidelines for authors of CMSG systematic reviews. Recommendations specific to musculoskeletal disorders are provided for various aspects of undertaking a systematic review, including literature searching, inclusion criteria, quality assessment, grading of evidence, data collection, and data analysis. These guidelines will help researchers design, conduct, and report results of systematic reviews of trials in the following fields of musculoskeletal health: gout, osteoarthritis, osteoporosis, pediatric rheumatology, rheumatoid arthritis, soft tissue rheumatism, spondyloarthropathy, systemic lupus erythematosus, systemic sclerosis, and vasculitis. Systematic reviews need to be conducted according to high methodological standards. These recommendations on developing and performing a systematic review will help improve consistency among CMSG reviews.

Clinical Trials as Topic↗
PubMed1989

Delegates approve protocol for third-party telephone review.

The Texas Medical Association Physician-Patient Advocacy Committee has conducted an extensive study of the telephone utilization review activities of private third-party payers and self-insured arrangements. Many of these organizations contract with private firms to conduct pre-certification and concurrent review of hospital admissions. These reviews often are accomplished by telephoning the attending physician's office. The procedures and criteria used by these firms and the qualifications of their review staff vary greatly. Physicians and their office staff are spending an increasing amount of time dealing with telephone utilization review. These review firms are not regulated or controlled by any agency. In response to the concerns expressed by physicians in dealing with telephone utilization review, Texas Medical Association's House of Delegates has approved the "Texas Medical Association Recommended Protocol for Physicians Responding to Private Third Party Telephone Review." The guidelines address concerns about confidentiality, physician documentation, patient advocacy, appeals, and cost and billing.

Confidentiality↗
PubMedDate not supplied

Utilization review and the family physician.

Family physicians are often in close contact with utilization review programs. Traditional hospital based review programs have included prehospital certification, outpatient and same-day surgery, second opinions, concurrent hospital review, and early discharge planning. The role of utilization review in ambulatory care is expected to increase in the future and will focus on the cost-effective allocation of resources. Family physicians need to be aware of several issues as they interact with utilization review programs, including the preservation of confidentiality, financial obligation in the face of negative review decisions, and the effect of utilization review on liability for adverse outcomes. Family medicine education should encourage familiarity with the structure and function of review programs and should enable practitioners to participate intelligently in such programs.

Adult↗
PubMed1994

How well does a journal's peer review process function? A survey of authors' opinions.

OBJECTIVE: To evaluate the authors' satisfaction or dissatisfaction with the peer review process of the Journal of Clinical Anesthesia. DESIGN: Anonymous questionnaires were sent to authors to survey their opinions about specific aspects of the peer review process. Authors were grouped by status of their manuscripts: AR (accept with revision), RR (reject but may resubmit), and RO (reject outright). PARTICIPANTS: Authors of unsolicited manuscripts submitted in 1991 to 1992. MAIN OUTCOME MEASURES: Factors that determine authors' satisfaction with the relevancy and benefit of peer review of their manuscript. RESULTS: Significantly more authors of AR manuscripts responded to our survey than did authors of rejected manuscripts and viewed the review process more favorably. Authors of AR manuscripts were more satisfied with specific aspects of the review process, which led to improvement in their manuscripts. More authors of RR manuscripts believed that our review process improved subsequent manuscript preparation than did authors of accepted manuscripts. CONCLUSIONS: The surveying of authors, important clients of the peer review process, should guide change necessary to better serve our authors and improve peer review.

Attitude↗
PubMed1979

The relationship between diagnostic information available at admission and discharge for patients in one PSRO setting: implications for concurrent review.

Professional Standards Review Organization (PSRO) operating guidelines recommend the use of Professional Activity Study (PAS) length of stay norms for conducting concurrent review. These norms, determined by aggregating discharge abstracts from PAS hospitals in the same United States census region, are assigned to patients based only on information known at admission. This study investigated the relationship between patient information available at admission and the information available at discharge in light of its effects on the concurrent review process. Analyzing 52,210 patient records from 68 hospitals in one PSRO setting, it was found that changes in patients' primary diagnosis resulted in changes in their PAS diagnostic category for 41.3 per cent of the patients. A change in PAS diagnostic caetgory after the assignment of the review norm resulted in missed and unnecessary reviews as well as early and late reviews. These findings indicate that there are serious operational problems with the current method of performing concurrent review.

Commission on Professional and Hospital Activities↗
PubMed2006

Female incontinence: a review of biomaterials and minimally invasive techniques.

PURPOSE OF REVIEW: This article discusses the various grafts or biomaterials, minimally invasive techniques, and recent advances for the treatment of female stress urinary incontinence and pelvic organ prolapse. RECENT FINDINGS: The studies reviewed in this paper compared certain biologic grafts to synthetic grafts in clinical trials and histopathological studies. Data from long-term outcome studies for tension-free vaginal tape are evaluated. As tension-free vaginal tape is the foremost technique for stress urinary incontinence correction, many of the newer modalities such as transobturator tape and laparoscopy are compared with it. Immediate and long-term complications from mesh use in stress urinary incontinence and pelvic organ prolapse repair are examined. Correction of prolapse may eventually entail the use of specially designed 'kits' that allow total pelvic floor reconstruction with a single piece of mesh. SUMMARY: Although biological grafts are initially efficacious, the trend is to use synthetic grafts in repair of stress urinary incontinence and pelvic organ prolapse. Midurethral slings continue to be the front-line therapeutic modality for stress urinary incontinence. After analysis of long-term data, other surgical techniques may gain popularity. With increasing use of synthetic grafts, however, long-term complications such as de-novo urgency, erosion, and dyspareunia need to be assessed.

Biocompatible Materials↗
PubMed1978

Use, costs, and quality of medical services: impact of the New Mexico peer review system. A 1971-1975 study.

To assess the effect of areawide peer review (such as that conducted by Professional Standards Review Organizations [PSROs]) on use, cost and quality of medical services, we evaluated 4 years of data on the efforts of the New Mexico Experimental Medical Care Review Organization in reviewing medical services for the Medicaid population. Utilization review had no demonstrable impact on hospital use; hospital days per 100 eligible persons rose 5.0% and 43.4% for persons enrolled all 4 years in Aid to Families with Dependent Children (AFDC) and Aid to the Permanently and Totally Disabled, respectively. Peer review produced no net dollar savings; over 4 years, the amount paid for all services per AFDC-eligible person rose 85%. Peer review improved the quality of ambulatory care through large reductions (75%) in medically unnecessary injections. If these findings are replicated elsewhere, they suggest that the goal of the PSRO program to control costs by curtailing utilization may be difficult to achieve, the quality of care goal may be pursued successfully, and the PSRO mission should be focused more on the latter.

Ambulatory Care↗
PubMed2000

[The systematic review is the foundation of evidence based medicine. One of the most important contributions to clinical medicine of the past decade].

The traditional narrative review has been shown repeatedly to be biased, mostly towards exaggerated treatment size effects. In contrast, the systematic review follows a strict protocol regarding focused questions, explicit criteria for literature searches, inclusion and exclusion criteria, critical appraisal and a synthesis which is quantitative when appropriate. There is empirical evidence that bias is reduced and that the conclusions reached have greater validity for the construction of treatment guidelines. In this paper three sources of systematic reviews are identified: the Cochrane Library, reviews published in peer-reviewed journals, and assessments of health technology (HTA-reports). Editors are encouraged to publish systematic reviews after proper critical appraisal, and readers are advised to search for such reviews when in need of guidance on important clinical questions.

Bias↗
PubMed2003

Problematic variation in local institutional review of a multicenter genetic epidemiology study.

CONTEXT: Sequencing of the human genome provides an immense resource for studies correlating DNA variation and epidemiology. However, appropriately powered genetic epidemiology studies often require recruitment from multiple sites. OBJECTIVES: To document the burden imposed by review of multicenter studies and to determine the variability among local institutional review boards (IRBs) in the approval of a multicenter genetic epidemiology study. DESIGN: A PubMed search was performed to determine the frequency of citations of multicenter studies by 5-year intervals from 1974 through 2002. A 7-question survey was sent to all participating study centers to obtain information on frequency of IRB meetings, dates for submission and approval, use/nonuse of a specific consent form, type of review performed, types of consent forms required, preparation time, and number of changes requested by the IRB at each center. Centers also provided a copy of all consent forms they generated and IRB correspondence regarding the study. SETTING AND PARTICIPANTS: Thirty-one of 42 cystic fibrosis care centers in this single US multicenter genetic epidemiology study of cystic fibrosis replied, yielding a 74% response rate. MAIN OUTCOME MEASURES: Frequency of published research studies and consistency among IRBs. RESULTS: The number of all published single-center studies has increased 1.3-fold since 1985, while the number of published epidemiology and genetic epidemiology multicenter studies increased by 8- and 9-fold, respectively, during this same period. Evaluation of the risk of the same genetic epidemiology study by 31 IRBs ranged from minimal to high, resulting in 7 expedited reviews (23%) and 24 full reviews (77%). The number of consents required by the IRBs ranged from 1 to 4; 15 IRBs (48%) required 2 or more consents, while 10 (32%) did not require assent for children. The most common concern (52%) of IRBs pertained to the genetic aspects of the study. CONCLUSIONS: Review of a protocol for a multicenter genetic epidemiology study by local IRBs was highly variable. Lack of uniformity in the review process creates uneven human subjects protection and incurs considerable inefficiency. The need for reform, such as the proposed centralized review, is underscored by the ever increasing rate of genetic discoveries facilitated by the Human Genome Project and the unprecedented opportunity to assess the relevance of genetic variation to public health.

Cystic Fibrosis↗
PubMed1995

Central pathology review in clinical trials for patients with malignant glioma. A Report of Radiation Therapy Oncology Group 83-02.

BACKGROUND: Confounding biologic factors, including histologic grade, may influence the outcome of adult patients with malignant gliomas more than may modifications in therapeutic approach. Any clinical trial design for malignant gliomas in adults must account for such biologic factors, including the accurate identification of the two histologic subgroups astrocytoma with anaplastic foci (AAF) or glioblastoma multiforme (GBM), which are associated with distinctly different survival outcomes. This paper examines the need for a central pathology review before entry of patients in cooperative group clinical trials stratified by histologic grade. METHODS: Pathology slides from Radiation Therapy Oncology Group (RTOG) trial 83-02, a randomized Phase II study of hyperfractionated and accelerated hyperfractionated radiation therapy and carmustine for malignant gliomas, provided 747 analyzable cases, with 680 (91%) available for central pathology review. This review was performed by a single pathologist according to RTOG/Eastern Cooperative Oncology Group histopathologic criteria. The kappa statistic was used to measure agreement between the institutional and central classification of AAF and GBM. The influence of misclassification was examined using computer simulation of varying clinical trial sizes (n = 25, 50, or 200). The effect on the statistical power of trials (n = 200) with varying mixtures of AAF and GBM tumors was investigated using computer simulations. RESULTS: Of 159 tumors classified as AAF by institutional pathology review, only 66% (105) were classified as AAF (AAF/AAF) by central review, and 54 of these cases (34%) were classified as GBM (GBM/AAF), whereas 96% (501) of 521 institutionally classified as GBM (GBM/GBM) were similarly classified by central review. Computer simulations demonstrated a 59% underestimation in the median survival (1.82 vs. 4.49 years) for trials of patients with institutionally defined AAF compared to patients with centrally defined AAF in studies of 200 patients, resulting from the addition of poor prognosis of GBM in the trial. Misclassification can also substantially reduce the statistical power of a clinical trial. In one of the simulation studies, statistical power was reduced from 65% to 14% if 50% of the patients were to receive an inaccurate histologic classification. Even greater losses in power are possible in many plausible clinical settings. CONCLUSIONS: This examination of a central versus an institutional pathology review demonstrates a low level of agreement on AAF classification and a high level of concordance on GBM classification. The results indicate the need to adjust sample size for trials of both AAF and GBM tumors to have adequate statistical power. A central pathology review remains essential for trial entry for patients with AAF and could be omitted for trials enrolling patients with GBM only.

Adult↗
PubMed2004

Blinded review of Papanicolaou smears in the context of litigation.

BACKGROUND: Blinded review has been endorsed by several cytology and pathology organizations as the most appropriate method for the review of cervicovaginal specimens in the context of litigation. Methods for determining the statistical validity of this method were evaluated. METHODS: First, the authors calculated the sample size needed to detect various differences in case difficulty or ease of interpretation, in which ease of interpretation is defined as the percentage of the time a case could be identified as abnormal by routine screening. Very easy cases could be identified most reliably, whereas more difficult cases were detected less regularly and less reliably. Using construct sample sizes, the authors calculated the number of abnormal reviews that may be helpful to conclude that the case's difficulty or ease of interpretation was statistically significantly different from another case of a specified difficulty. Finally, they examined the effect of using two separate cutoff parameters to make these distinctions. RESULTS: Depending on the threshold chosen, it was determined that improvements in the statistically meaningful distinctions may be made using 15 or 20 reviews. To distinguish between routine false-negative cases (ease of detection, 40%) and routine cases (ease of detection, 80%), the thresholds may be set at 5 of 10 reviews (a case that would not be detected regularly and reliably in any given laboratory) and 7 of 10 reviews (defining a case that would be identified regularly and reliably), respectively. CONCLUSIONS: The authors provide data that can be used to interpret the results of a blinded review in a statistically appropriate manner. To improve the utility of blinded reviews, the standards are defined explicitly.

Data Interpretation, Statistical↗