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Exercise therapy for low back pain: a systematic review within the framework of the cochrane collaboration back review group.

STUDY DESIGN: A systematic review of randomized controlled trials was performed. SUMMARY OF BACKGROUND DATA: Exercise therapy is a widely used treatment for low back pain. OBJECTIVES: To evaluate the effectiveness of exercise therapy for low back pain with regard to pain intensity, functional status, overall improvement, and return to work. METHODS: The Cochrane Controlled Trials Register, Medline, Embase, PsycLIT, and reference lists of articles were searched. Randomized trials testing all types of exercise therapy for subjects with nonspecific low back pain with or without radiation into the legs were included. Two reviewers independently extracted data and assessed trial quality. Because trials were considered heterogeneous with regard to study populations, interventions, and outcomes, it was decided not to perform a meta-analysis, but to summarize the results using a rating system of four levels of evidence: strong, moderate, limited, or none. RESULTS: In this review, 39 trials were identified. There is strong evidence that exercise therapy is not more effective for acute low back pain than inactive or other active treatments with which it has been compared. There is conflicting evidence on the effectiveness of exercise therapy compared with inactive treatments for chronic low back pain. Exercise therapy was more effective than usual care by the general practitioner and just as effective as conventional physiotherapy for chronic low back pain. CONCLUSIONS: The evidence summarized in this systematic review does not indicate that specific exercises are effective for the treatment of acute low back pain. Exercises may be helpful for patients with chronic low back pain to increase return to normal daily activities and work.

Exercise Therapy↗

Multidisciplinary biopsychosocial rehabilitation for subacute low back pain in working-age adults: a systematic review within the framework of the Cochrane Collaboration Back Review Group.

STUDY DESIGN: A systematic review of randomized controlled trials was performed. OBJECTIVE: To evaluate the effectiveness of multidisciplinary biopsychosocial rehabilitation for subacute low back pain among working-age adults. SUMMARY OF BACKGROUND DATA: Multidisciplinary biopsychosocial rehabilitation programs are widely applied for patients with chronic low back pain. The multidisciplinary biopsychosocial approach for prolonged low back pain could be considered to prevent chronicity. Work site visits and a close relationship with occupational health care might produce results in terms of patients working ability. METHODS: Reviewed randomized controlled trials as well as controlled trials were identified from electronic bibliographic databases, reference checking, and consultation with experts in the rehabilitation field. Four blinded reviewers selected the trials. Two rehabilitation specialists evaluated the clinical relevance. Two other blinded reviewers extracted the data and assessed the main results along with the methodologic quality of the studies. A qualitative analysis was performed to evaluate the level evidence. RESULTS: Of 1808 references, only 2 relevant studies were included. Both were considered to be methodologically low-quality randomized controlled trials. The clinical relevance of the studies was sufficient. The level of scientific evidence was moderate, showing that multidisciplinary rehabilitation involving work site visit or more comprehensive occupational health care intervention helps patients return to work faster, makes sick leaves less, and alleviates subjective disability. CONCLUSIONS: There is moderate evidence showing that multidisciplinary rehabilitation for subacute low back pain is effective, and that work site visit increases the effectiveness, but because the analyzed studies had some methodologic shortcomings, an obvious need still exists for high-quality trials in this field.

Humans↗

A review of evidence-based medicine and meta-analytic reviews in migraine.

The following systematic reviews and meta-analyses are presented and the results discussed: the evidence-based American guidelines, five systematic reviews on naratriptan, rizatriptan, eletriptan, sumatriptan and propranolol; a meta-analysis of sumatriptan, a meta-analysis of acute migraine therapy, a meta-analysis of triptans available in Canada and a large meta-analysis of oral triptans. The systematic reviews of several randomized trials of one drug overcome random effects in estimating treatment effect of the reviewed drug. The results from the large meta-analysis of several drugs are compared with head-to-head comparative trials. Results are generally the same in the meta-analysis and in the comparative trials, with some exceptions. Head-to-head comparisons should remain the 'gold standard' and meta-analyses are a useful supplement in cases when comparative trials are relatively small and when no comparative trials exist.

Analgesics↗

Spontaneous bleeding associated with ginkgo biloba: a case report and systematic review of the literature: a case report and systematic review of the literature.

BACKGROUND: Ginkgo biloba (ginkgo) is a herbal remedy used by over 2% of the adult population in the United States. Several review articles have suggested that ginkgo may increase the risk of bleeding. OBJECTIVE: To report a case of bleeding associated with using ginkgo, to systematically review the literature for similar case reports, and to evaluate whether using ginkgo is causally related to bleeding. DATA SOURCES: We searched MEDLINE, EMBASE, IBIDS, and the Cochrane Collaboration Database from 1966 to October 2004 with no language restrictions. REVIEW METHODS: Published case reports of bleeding events in persons using ginkgo were selected. Two reviewers independently abstracted a standard set of information to assess whether ginkgo caused the bleeding event. RESULTS: Fifteen published case reports described a temporal association between using ginkgo and a bleeding event. Most cases involved serious medical conditions, including 8 episodes of intracranial bleeding. However, 13 of the case reports identified other risk factors for bleeding. Only 6 reports clearly described that ginkgo was stopped and that bleeding did not recur. Bleeding times, measured in 3 reports, were elevated when patients were taking ginkgo. CONCLUSION: A structured assessment of published case reports suggests a possible causal association between using ginkgo and bleeding events. Given the widespread use of this herb and the serious nature of the reported events, further studies are needed. Patients using ginkgo, particularly those with known bleeding risks, should be counseled about a possible increase in bleeding risk.

Aged↗

Effectiveness of different databases in identifying studies for systematic reviews: experience from the WHO systematic review of maternal morbidity and mortality.

BACKGROUND: Failure to be comprehensive can distort the results of a systematic review. Conversely, extensive searches may yield unmanageable number of citations of which only few may be relevant. Knowledge of usefulness of each source of information may help to tailor search strategies in systematic reviews. METHODS: We conducted a systematic review of prevalence/incidence of maternal mortality and morbidities from 1997 to 2002. The search strategy included electronic databases, hand searching, screening of reference lists, congress abstract books, contacting experts active in the field and web sites from less developed countries. We evaluated the effectiveness of each source of data and discuss limitations and implications for future research on this topic. RESULTS: Electronic databases identified 64098 different citations of which 2093 were included. Additionally 487 citations were included from other sources. MEDLINE had the highest yield identifying about 62% of the included citations. BIOSIS was the most precise with 13.2% of screened citations included. Considering electronic citations alone (2093), almost 20% were identified uniquely by MEDLINE (400), 7.4% uniquely by EMBASE (154), and 5.6% uniquely by LILACS (117). About 60% of the electronic citations included were identified by two or more databases. CONCLUSIONS: This analysis confirms the need for extending the search to other sources beyond well-known electronic databases in systematic reviews of maternal mortality and morbidity prevalence/incidence. These include regional databases such as LILACS and other topic specific sources such as hand searching of relevant journals not indexed in electronic databases. Guidelines for search strategies for prevalence/incidence studies need to be developed.

Female↗

Cochrane reviews and systematic reviews of economic evaluations. Amantadine and rimantadine in the prevention and treatment of influenza.

Cochrane reviews provide standardised and regularly updated syntheses of evidence on the effects of healthcare interventions. We present the rationale for, and some of the results of, a Cochrane review of the effects of amantadine and rimantadine in the prevention and treatment of influenza. The estimates of effect will be incorporated into a decision-making model for tackling influenza in healthy adults (i.e. soldiers in the British Army). Our systematic review of the economics of influenza also provides the international context within which economic data can be interpreted and assessed as a preliminary to an economic evaluation comparing alternative prevention and treatment strategies. Systematic reviews provide powerful and relatively inexpensive evidence of effects and tolerability, which is more likely to convince decision-makers than evidence from single studies. Additionally, they can be used to focus clinical trial questions and provide strategic insight regarding the state-of-the-art knowledge of effects and economics of compounds in a specific field.

Adult↗

Legal review: a case study from California--the sharing of peer review information between hospitals and nonhospital providers.

You are the chief executive officer of Friendly Neighbor Medical Center, an acute care hospital. On your desk is a letter from your counterpart at The Behemoth Clinic, a large local medical group that not only is very active in managed care contracting in your service area, but also has an important relationship with your hospital. Behemoth has requested extensive access to Friendly Neighbor's peer review files and patient records in order to investigate the care provided by one of Behemoth's physicians. You happen to be aware that the physician has been the subject lately of peer review scrutiny at your hospital, and you would like to cooperate with Behemoth. Can you do so without jeopardizing the legal confidentiality protections available to your hospital's peer review records, not to mention the peer review process generally?

California↗

A peer review review.

Although peer reviewer has faced many legal challenges, some protection is available to peer reviewers through state and federal law. Peer reviewers must follow specific guidelines provided by these laws to maintain this protection. This article outlined the most prominent protection currently available as well as the corollary duties and requirements by which the peer reviewers must abide.

Peer Review↗

Peer review--the West Australian experience. The West Australian Peer Review Sub-Committee.

In view of the Department of Health's recommendations that Peer Review be accepted as an integral part of the medical system, local members of the college volunteered to take part in a pilot study. Those involved were divided into three groups and were left to devise their own system. Following subsequent discussion and assessment, a workable scheme evolved as described. This system employs a 'rolling' or an ongoing technique in which a group of four psychiatrists form the peer review group. Following each assessment a new member joins the team and the longest serving person is assessed before leaving. The problems and difficulties of peer review are discussed and the importance of the link between peer review and continuing education is stressed.

Australia↗

Searching for an efficient institutional review board review model: Interrelationship of trainee-investigators, funding, and initial approval.

In this study we sought to identify variables associated with institutional review board (IRB) decisions to develop an efficient "pre-IRB" review model. We explored several variables, including relationships among the identification of trainees as investigators, external sources of funding, and initial approval. The sample consisted of all new submissions reviewed by the 2 medical IRBs at the University of Miami (UM) during a 1-year period. Trainees included students, residents, and fellows. At least 1 trainee had to be identified for a proposal to be considered a trainee submission. The medical-science committees (MSCs) were similar with regard to the numbers of new submissions they reviewed during convened meetings (MSC-A 242, MSC-B 241) and the percentages of proposals that were initially approved (MSC-A 52.9%, MSC-B 53.1%). Approved submissions were defined as those initially approved or conditionally approved pending minor modifications. We noted a robust statistical difference between the percentages of trainee submissions initially approved (39.9%) and submissions that did not identify a trainee (59.4%) ( P <.0001). Of the proposals that were initially not approved (tabled [deferred] or rejected [not approved]), 28.9% of those including a trainee were rejected, compared with 11.0% without a trainee ( P <.001). Proposals in which the source of funding was identified were more likely to be approved (64.2%) than were those in which it was not (30.8%) ( P <.0001). Funding also seemed to influence the trainee and initial-approval interaction. Our results show that new submissions that identified trainee investigators were more likely to be deferred or not approved than those that did not. Nonapproved proposals that identified a trainee were 3.8 times more likely to be initially rejected than those that did not. A prereview model could target those submissions that list a trainee, lack funding, or both.

Efficiency, Organizational↗

Scientific review of EORTC trials: the functioning of the New Treatment Committee and Protocol Review Committee.

New anticancer treatments (new therapeutic strategies or new compounds) require careful development in which cancer clinical trials are an essential element. Two scientific committees, namely the New Treatment Committee and the Protocol Review Committee, ensure the review of all EORTC protocols with respect to the interest and originality, methodology, feasibility and relevance within the EORTC framework. Both Committees are involved early in the evaluation of the new concept proposal and follow all aspects (methodology, administrative, regulatory) of the protocol development process. Throughout its 25 years of existence, the Protocol Review Committee has streamlined drug and protocol evaluations and has developed standard operating procedures to handle those reviews in a very efficient and fast manner. Since 1997, the New Treatment Committee has contributed to strengthening the EORTC during the development process with the aim of ensuring an optimal flow of information on new drugs between laboratory and clinical research divisions.

Clinical Protocols↗

Review of negative Papanicolaou tests. Is the retrospective 5-year review necessary?

New federal regulations require review of all available negative gynecologic smears within the previous 5 years for each patient with a current high grade squamous intraepithelial lesion (HGSIL) or above. Two university hospitals retrospectively reviewed all patients who had HGSIL or above and who had prior negative smears. During 18 months, 35,807 Papanicolaou tests were reported, from which we identified 44 patients with 80 negative smears before presenting with HGSIL or above. These 80 negative smears were rescreened and, on review, there was agreement with the original diagnosis in 66 cases (82.5%). Fourteen (17.5%) smears were reclassified: 2 unsatisfactory, 6 atypical squamous/glandular cells of undetermined significance, 3 low grade SIL, and 3 HGSIL or above. Of the 12 cases satisfactory for reclassification, 9 (75%) occurred within 2 years before the HGSIL or above. Two cases of atypical squamous/glandular cells occurred within 4 years. One case of HGSIL occurred more than 4 years before, but a negative Pap smear had been reclassified within the year before the diagnosis of HGSIL. The authors conclude that a 2-year retrospective review, which identified 75% of our false-negative cases, is an effective and efficient quality control and assurance practice.

False Negative Reactions↗

Structured review of enamel erosion literature (1980-1998): a critical appraisal of experimental, clinical and review publications.

OBJECTIVE: To attain an objective account of the methods to measure enamel erosion used in 1980-1998 publications, a structured review of the literature was undertaken. METHODS: Inclusion and exclusion criteria were applied to 731 clinical/experimental research and review reports. Eighty-five included papers were subsequently rated according to 'hierarchy of evidence' guidelines to assess the strength of the report's design and the relevance of the evidence to replicating enamel erosion in vivo in humans. Scores were assigned to rate each aspect in the guidelines. RESULTS: A total of 16 clinical, 13 review and 56 experimental papers were assessed; 36.4% were published during 1996-1998. Excluding reviews, 16 papers were qualitative and 56 quantitative; 51 used human enamel. Our classification yielded nine groups of methods (five scoring systems and 26 measurement techniques). CTFPHE (Can Med Assoc J 1992; 147: 443) grading of research reports indicated that 2.8% provided evidence grade I; 20.8%, grade IIa; 63.9%, grade III; and 12.5%, grade IV. CONCLUSIONS: There has been a consistent increase in the body of knowledge. The overall quality of publications has not substantially changed over time. Experimental studies were more often quantitative, and quantitative studies had better research designs. No single group of research methods had obviously superior research designs.

Analysis of Variance↗

Supplementing the traditional institutional review board with an environmental health and community review board.

BACKGROUND: Community-based research often involves additional ethical, legal, and social considerations beyond those of the specific individuals involved in the study. The traditional institutional review board (IRB) typically focuses on protecting the rights and ensuring the safety of the individuals involved. For projects involving community members, IRBs should be more sensitive to issues related to the broader community concerns. OBJECTIVES: The objective of this article is to discuss the concept of community-based participatory research and the shortcomings of the traditional IRBs in dealing with ethical issues associated with broader community concerns such as implications for family members, neighborhood groups, and local businesses. I examine the rationale and benefits for expanding the roles and responsibilities of review boards related to community-based issues. DISCUSSION: I propose the development of environmental health and community review boards (EHCRBs) that combine the fundamental responsibilities and ethical concept of the traditional review boards with an expanded ethical construct of dignity, veracity, sustainability, and justice, with an added emphasis on community. CONCLUSIONS: Only by acknowledging the needs of and working with the community can we ensure ethically based and socially responsible research. An EHCRB will allow researchers and community members to more fully address their mutual interest in conducting scientific, ethical, and socially responsible research.

Environmental Health↗

Medicare program; Provider Reimbursement Review Board: expedited administrative review--Health Care Financing Administration. Final rule with comment period.

Current Medicare regulations permit providers of services to appeal reimbursement decisions of Medicare fiscal intermediaries to the Provider Reimbursement Review Board. Following the Board's decision, the provider may also request judicial review of that decision (and of any action by the Secretary with respect to that decision). These amendments to our regulations permit the provider to obtain expedited administrative review when the Board determines that it lacks authority to decide a question of law, regulation, or HCFA ruling relevant to the case. The question of whether authority is lacking may be raised by the provider or on the Board's own motion. The regulations eliminate the current requirement for a Board hearing before judicial review when the Board lacks authority to decide an issue, and they establish time limits within which the Board must act. These rules implement section 955 of the Omnibus Reconciliation Act of 1980, Pub. L. 96-499.

Centers for Medicare and Medicaid Services, U.S.↗

Reviewing histologic diagnosis of lymphoma: comparison of original and review diagnoses in 269 cases.

By analyzing the pathology records of patients at Emory University Hospital, Atlanta, who had a diagnosis of suspected or proved malignant lymphoma (ML) based on examination of a biopsy specimen obtained elsewhere, the rates of agreement between original and review diagnoses were determined. Ninety-six percent of the cases submitted as ML were accepted as ML on review. In 96% of those referred to us as non-Hodgkin's lymphoma (NHL), this diagnosis was confirmed. All cases submitted as Hodgkin's disease (HD) were accepted as ML, but 13% were reclassified as NHL. Based on the review diagnoses, expressed according to the Lukes-Butler (HD) or Rappaport (NHL) classifications, 69% of the HD cases and 29% of the NHL cases bore original diagnoses that agreed. Nonuse and incorrect use of standard classifications contributed greatly to these discrepancies. Pathology review is strongly recommended for all cases of ML, to reduce diagnostic error where possible and to promote the use of histopathologic terminology that bears on clinical decisions.

Biopsy↗

Hospital rate review. A theory and an empirical review.

This paper presents a theory of the effects of rate review on hospital operations and organization. Its purpose is to explain the way in which hospitals have responded to regulation. In the development of this theory, the hospital product was viewed as a bundle of services, rate review was looked upon as a ceiling on the value of the bundle. The ceiling creates an incentive to remove elements from the bundle, i.e., to reduce 'quality'. When quality is variable, the effect on utilization becomes indeterminate. The model argues, among other things, that the hospital will change its service complement and its contractural arrangements with physicians and other hospitals. An extension of the organizational theory literature leads to implications concerning the ordering of hospital responses to regulation. The growing body of empirical literature on the effects of hospital rate review is used as an initial test of the major thrusts of the theory. A suggested agenda for further empirical work also is presented.

Cost Control↗

Agreement among reviewers of review articles.

OBJECTIVE: To assess the consistency of an index of the scientific quality of research overviews. DESIGN: Agreement was measured among nine judges, each of whom assessed the scientific quality of 36 published review articles. ITEM SELECTION: An iterative process was used to select ten criteria relative to five key tasks entailed in conducting a research overview. SAMPLE: The review articles were drawn from three sampling frames: articles highly rated by criteria external to the study; meta-analyses; and a broad spectrum of medical journals. JUDGES: Three categories of judges were used: research assistants; clinicians with research training; and experts in research methodology; with three judges in each category. RESULTS: The level of agreement within the three groups of judges was similar for their overall assessment of scientific quality and for six of the nine other items. With four exceptions, agreement among judges within each group and across groups, as measured by the intraclass correlation coefficient (ICC), was greater than 0.5, and 60% (24/40) of the ICCs were greater than 0.7. CONCLUSIONS: It was possible to achieve reasonable to excellent agreement for all of the items in the index, including the overall assessment of scientific quality. The implications of these results for practising clinicians and the peer review system are discussed.

Information Services↗