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Current status of biomedical book reviewing. II. Time lag in biomedical book reviewing.

This part of the study explores the effectiveness of the review media in terms of speed of reviewing, comprehensiveness of review treatment, and authority. The time lags for the fifty-four journals varied widely, the mean ranging from 5.8 months to forty-two months. The time lags for all 3,347 reviews varied even more widely, ranging from less than a month to 108 months after a book was off the press. The 3,347 reviews had a mean time lag of 10.43 months and a standard deviation of 6.63 months.

Book Reviews as Topic↗

Conceptual framework for drug usage review, medical audit and other patient care review procedures.

The following concepts are discussed: (1) quality assurance programs, (2) drug usage review, (3) utilization review, (4) peer review, (5) medical audit, (6) patient care audit and (7) medical care evaluation studies. A framework within which all types of hospital quality assurance mechanisms can be constructed is proposed and their interrelationships are described. The pharmacist's particpiation in the hospital's overall quality assurance program is stressed in two main areas-drug usage review, performed jointly with the medical staff, and quality assurance of pharmaceutical services, a peer review function of the pharmacy profession. These services are primarily drug distribution and control, drug information, clinical pharmacy, continuing education, and other pharmacy and pharmacist functions. Both functions may be viewed as parts of the pharmacy audit, one of several patient care audits within the facility. Pharmacists in skilled nursing facilities have quality assurance responsibilities similar to those of hospital-based pharmacists.

Drug Utilization↗

Ovid's evidence-based medicine reviews: a review of a clinical information product.

Evidence-Based Medicine Reviews (EBMR) is a new full-text product from Ovid Technologies. EBMR supports the practice of evidence-based medicine (EBM) by providing access to two premiere EBM resources: the Cochrane Database of Systematic Reviews from the international Cochrane Collaboration, and Best Evidence from the American College of Physicians-American Society of Internal Medicine. Both resources alert health care professionals, researchers, and librarians to clinically relevant and methodologically sound studies by providing access to full-text reviews and meta-analyses of clinical literature. Value-added features include links to EBMR from MEDLINE, alerting MEDLINE users to available reviews. An "EBM Reviews" limit within MEDLINE facilitates access to the EBMR database contents.

Databases as Topic↗

Systematic reviewing in laboratory medicine. Position Paper from the IFCC Committee on Systematic Reviewing in Laboratory Medicine.

Each year a vast number of biomedical articles and books are published and based on the articles reviews are written. Such reviews should be performed in a systematic manner. Systematic reviewing is a new discipline with its own methods for locating, appraising, and summarizing primary studies. Such methods have also been developed for studies on diagnostic test evaluations. It is important for the laboratory disciplines to engage in this work. IFCC has established a Committee for Systematic Reviewing in Laboratory Medicine. This committee will work to promote the understanding, the use and the performance of systematic reviewing.

Clinical Chemistry Tests↗

Medical devices; implementation of third party review under the Food and Drug Administration Modernization Act of 1997; emergency processing request under OMB review--FDA. Notice.

The Food and Drug Administration (FDA) is announcing a program under which persons may be accredited to review premarket notifications and recommend initial classification of certain medical devices. At the same time, FDA is announcing the termination of the Third Party Review Pilot Program. This notice announces the criteria to accredit or deny accreditation to persons (Accredited Persons) who request to conduct premarket notification reviews consistent with provisions of the FDA Modernization Act of 1997 (FDAMA). FDA is also announcing that this proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). FDA is requesting OMB approval within 45 days of receipt of this submission. FDA is taking this action to implement section 210 of FDAMA. The availability of guidance detailing the review of submissions, training for third party reviewers, and basic document processing by FDA is announced elsewhere in this tissue of the Federal Register.

Accreditation↗

Dispensing review: BVA's evidence to the Independent Review Group.

The BVA has submitted two sets of evidence to the Independent Review Group on dispensing (IRG), which was established by the Government 'to review the procedures by which prescription only medicines (POMS) for veterinary use are classified and sold in the UK, and the impact current practices may be having on availability and prices'. The first submission consisted of a transcript of the proceedings of the one-day seminar on medicines organised by the BVA at its recent congress in Chester, which heard from all sides in the debate and was attended by all members of the review group (see VR, October 21, pp 463-466). In its second submission, which is reproduced here, the Association discusses the review in the context of overall policy on veterinary medicines and, as requested by the review group, provides data on the costs and margins involved in providing a 24-hour pharmacy within a 'one stop' veterinary service. In submitting its evidence, the BVA noted that some of its divisions had submitted separate papers discussing prescribing in particular sectors of the profession and for particular species. While its own evidence did not go over the same ground again, it nevertheless emphasised its support for the messages those submissions contained.

Animals↗

Extending systematic reviews to include evidence on implementation: methodological work on a review of community-based initiatives to prevent injuries.

Unintentional injury is a leading cause of mortality and disability among young and old. While evidence about the effectiveness of interventions in reducing injuries is accumulating, reviews of this evidence frequently fail to include details of implementation processes. Our research, of which the work reported here formed a part, had two main objectives: (1) to identify evidence about the implementation of interventions aimed at reducing unintentional injuries amongst children and young people; and (2) to explore methods for systematically reviewing evidence on implementation. Existing systematic reviews of the effectiveness of interventions aiming to reduce unintentional injuries in children and young people formed the starting point for the work reported here. In summary, many of the published papers we identified contained little information on implementation processes and, even when these were discussed, the extent to which authors' claims were based on research evidence was unclear. On the basis of the studies we reviewed implementation data were insufficiently strong to provide a sound evidence base for practitioners and policymakers. Notwithstanding this, we identified valuable data about the context in which such initiatives are implemented and the type of factors that might impinge on implementation. This work has implications in three areas: (1) researchers with an interest in evidence-based public health could be encouraged to consider implementation issues in the design of intervention studies; (2) funding bodies could be encouraged to prioritise intervention studies using mixed methods that will enable researchers to consider effectiveness and implementation; (3) journal editors could work towards increasing the quality of reporting on implementation issues through the development of guidelines.

Accident Prevention↗

Use of information-seeking strategies for developing systematic reviews and engaging in evidence-based practice: the application of traditional and comprehensive Pearl Growing. A review.

BACKGROUND: Efficient library searches for research evidence are critical to practitioners who wish to engage in evidence-based practice (EBP) as well as researchers who seek to develop systematic reviews. AIMS: This review will propose the benefits of the search technique 'Pearl Growing' ('Traditional Pearl Growing') as well as an adaptation of this technique ('Comprehensive Pearl Growing'), until now ignored by the literature on EBP and systematic reviews, to aid in the retrieval of research evidence. These search techniques are illustrated with examples from the field of augmentative and alternative communication. MAIN CONTRIBUTIONS: Traditional Pearl Growing is proposed as an important addition to the arsenal of EBP search strategies for practitioners. The literature on Traditional Pearl Growing is extended in that EBP presents a newly identified purpose for this technique and the benefits in identifying appropriate quality filter goes beyond its previously exclusive focus on keywords. Comprehensive Pearl Growing is projected as a new strategy for researchers searching for studies to be included in systematic reviews. Not only does it provide data-based guidance in selecting effective keywords and quality filters, but also it provides appropriate databases. CONCLUSIONS: Although the techniques Traditional Pearl Growing and Comprehensive Pearl Growing are believed to be useful for locating research evidence in any field, it may be particularly important for interdisciplinary topics where the use of effective controlled vocabulary plays a greater role in bringing together evidence that may be scattered across databases.

Communication Disorders↗

External peer review in Europe: an overview from the ExPeRT Project. External Peer Review Techniques.

OBJECTIVE: This paper aims to evaluate the use and development of external peer review models and to identify where the main models are used in European Union member states and countries with reciprocal research agreements with the European Union. DESIGN: The ExPeRT (external peer review techniques) project research team conducted a series of fact-finding missions to all participating European nations. Study participants. I. Blomberg, Sweden; L. Bohigas, Spain; S. Cucic, The Netherlands; P. Morosini, Italy. The Project is led by C. Shaw, UK and is managed by C. Heaton, CASPE Research. RESULTS: We identified four main external peer review models aimed at measuring the quality of service management and delivery: health care accreditation, the International Organization for Standardization ISO 9000 standards, the European Foundation for Quality Management Excellence Model and visitatie, which is Dutch for 'visitation' or peer review-based schemes. DISCUSSION: ExPeRT has demonstrated that in principle, convergence of the four main models in order to gain from each model's key strengths is feasible. Whether convergence is practical, depends upon the willingness of governments, health service providers, health care quality professionals and organizations to come together and adopt the recommendations of the ExPeRT project.

Accreditation↗

Integrated care programmes for chronically ill patients: a review of systematic reviews.

OBJECTIVE: To investigate effectiveness, definitions, and components of integrated care programmes for chronically ill patients on the basis of systematic reviews. DESIGN: Literature review from January 1996 to May 2004. MAIN MEASURES: Definitions and components of integrated care programmes and all effects reported on the quality of care. RESULTS: Searches in the Medline and Cochrane databases identified 13 systematic reviews of integrated care programmes for chronically ill patients. Despite considerable heterogeneity in interventions, patient populations, and processes and outcomes of care, integrated care programmes seemed to have positive effects on the quality of patient care. No consistent definitions were present for the management of patients with chronic illnesses. In all the reviews the aims of integrated care programmes were very similar, namely reducing fragmentation and improving continuity and coordination of care, but the focus and content of the programmes differed widely. The most common components of integrated care programmes were self-management support and patient education, often combined with structured clinical follow-up and case management; a multidisciplinary patient care team; multidisciplinary clinical pathways and feedback, reminders, and education for professionals. CONCLUSION: Integrated care programmes seemed to have positive effects on the quality of care. However, integrated care programmes have widely varying definitions and components and failure to recognize these variations leads to inappropriate conclusions about the effectiveness of these programmes and to inappropriate application of research results. To compare programmes and better understand the (cost) effectiveness of the programmes, consistent definitions must be used and component interventions must be well described.

Chronic Disease↗

A systematic review of how homeopathy is represented in conventional and CAM peer reviewed journals.

BACKGROUND: Growing popularity of complementary and alternative medicine (CAM) in the public sector is reflected in the scientific community by an increased number of research articles assessing its therapeutic effects. Some suggest that publication biases occur in mainstream medicine, and may also occur in CAM. Homeopathy is one of the most widespread and most controversial forms of CAM. The purpose of this study was to compare the representation of homeopathic clinical trials published in traditional science and CAM journals. METHODS: Literature searches were performed using Medline (PubMed), AMED and Embase computer databases. Search terms included "homeo-pathy, -path, and -pathic" and "clinical" and "trial". All articles published in English over the past 10 years were included. Our search yielded 251 articles overall, of which 46 systematically examined the efficacy of homeopathic treatment. We categorized the overall results of each paper as having either "positive" or "negative" outcomes depending upon the reported effects of homeopathy. We also examined and compared 15 meta-analyses and review articles on homeopathy to ensure our collection of clinical trials was reasonably comprehensive. These articles were found by inserting the term "review" instead of "clinical" and "trial". RESULTS: Forty-six peer-reviewed articles published in a total of 23 different journals were compared (26 in CAM journals and 20 in conventional journals). Of those in conventional journals, 69% reported negative findings compared to only 30% in CAM journals. Very few articles were found to be presented in a "negative" tone, and most were presented using "neutral" or unbiased language. CONCLUSION: A considerable difference exists between the number of clinical trials showing positive results published in CAM journals compared with traditional journals. We found only 30% of those articles published in CAM journals presented negative findings, whereas over twice that amount were published in traditional journals. These results suggest a publication bias against homeopathy exists in mainstream journals. Conversely, the same type of publication bias does not appear to exist between review and meta-analysis articles published in the two types of journals.

Bias↗

Legal issues raised by private review activities of medical peer-review organizations.

Increasingly, medical peer-review organizations are entering into contracts with insurance companies and self-insured employers to conduct utilization reviews and quality-of-care assessments. Such private review activities raise new legal issues, requiring analysis of state law as well as federal law. This paper analyzes several of the most important of these legal issues, and suggests some directions for peer-review organizations to take in order to avoid unnecessary legal problems.

Confidentiality↗

The four basic types of evaluation: clinical reviews, clinical trials, program reviews, and program trials.

Four basic types of evaluation, each appropriate in a distinctive situation, are the clinical review and the clinical trial, which are concerned with the care of the individual patient, and the program review and program trial, which deal with programs or services directed at groups or populations. Evaluative reviews are primarily motivated by concern with the welfare of the specific population served, and they appraise specific activities in specific settings as a basis for decisions concerning these activities. Clinical and program trials aim to generate knowledge of more general applicability, especially concerning causal relationships between care and outcomes. The types of evaluation differ in the questions they pose and in the methods used to answer them. Failure to draw a distinction between program reviews and program trials is a frequent cause of wasteful or unhelpful evaluative studies.

Consumer Behavior↗

The art and science of reviewing manuscripts for orthopaedic journals: Part II. Optimizing the manuscript: practical hints for improving the quality of reviews.

Manuscripts submitted to musculoskeletal journals have several key components that need to be critically evaluated. There are specific methods to assess the abstract, illustrations, references, and other major elements of a manuscript under review. If each of these elements is assessed methodically, not only does the quality of the review improve, but it becomes more useful for the journal editor. Additionally, the method in which the review is conveyed has a marked impact on its usefulness. There should be a concise evaluation of the entire work, stating whether a publication should or should not be pursued. For poor manuscripts, several bulleted points that indicate the fatal flaw(s) are sufficient, but for good manuscripts, a systematic itemization of weaknesses will improve the quality of the manuscript. Reviews should not be derogatory and should be prompt and to the point.

Humans↗

Supporting dyslexic adults--a need for clarity (and more research): a critical review of the Rice report 'Developmental Dyslexia in Adults: A Research Review'.

Evidence based teaching methods are desirable not only for economic efficiency but also important for ensuring the learner is engaged in meaningful activity. Therefore, a review of the research that could inform both teaching practice and future research is to be welcomed. However, the NRDC review 'Developmental Dyslexia in Adults: A Research Review' contains so many methodological flaws, including the highly selective way in which the research has been used, that the overall value of the report is questionable. In this paper the authors have attempted to highlight the main issues of why this report appears to fall short of being a full 'Research Review'.

Achievement↗

Evaluation of Institutional Review Board review and informed consent in publications of human research in critical care medicine.

OBJECTIVE: To examine the frequency of obtaining Institutional Review Board (IRB) approval and informed consent in critical care research. DATA SOURCES AND DATA EXTRACTION: One-year retrospective review of original critical care research in humans published in seven journals, including American Journal of Respiratory and Critical Care Medicine, Chest, Critical Care Medicine, Intensive Care Medicine, The Journal of the American Medical Association, Lancet, and The New England Journal of Medicine. Studies were examined for general information (country/state where the research was performed, affiliation of the hospital to a medical school, and whether the work was supported by a grant and specifically by a pharmaceutical company), approval by IRB, method of consent, design of research, and interventions involved in the study. DATA SYNTHESIS: Two hundred seventy-nine studies were reviewed, 124 (44%) of which were conducted in the United States. Two hundred forty-three (87%) studies were performed in a university institution, 96 (34%) studies were supported by a grant, and 23 (24%) studies were supported by a pharmaceutical company. In 66 (24%) studies, there was no evidence of IRB review and informed consent approval. IRB approval was obtained but the method of consent was not specified in 36 (13%) studies. No significant differences were found in obtaining IRB approval and informed consent between research conducted in the United States (n=71, 57%) or outside the United States (n=92, 59%). Grant support was obtained in ten (9%) of the 116 studies not fully approved, compared with 70 (50%) of the 140 studies that obtained full approval (p < .05). All studies (23) supported by the pharmaceutical industry were fully approved. CONCLUSIONS: Many published studies in critical care lack IRB approval and/or informed consent. All research supported by the pharmaceutical industry was fully approved. The findings raise ethical concerns about critical care research.

Bibliometrics↗

Nonsteroidal anti-inflammatory drugs for low back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group.

STUDY DESIGN: A systematic review of randomized and double-blind controlled trials was performed. SUMMARY OF BACKGROUND DATA: Nonsteroidal anti-inflammatory drugs are the most frequently prescribed medications worldwide and are widely used for patients with low back pain. OBJECTIVES: To assess the effects of nonsteroidal anti-inflammatory drugs in the treatment of nonspecific low back pain with or without radiation, and to assess which type of nonsteroidal anti-inflammatory drug is most effective. METHODS: For this study, the Cochrane Controlled Trials Register, Medline and Embase, and reference lists of articles were searched. Two reviewers blinded with respect to authors, institution, and journal independently extracted data and assessed the methodologic quality of the studies. If data were considered clinically homogeneous, a meta-analysis was performed. If data were considered clinically heterogeneous, a qualitative analysis was performed using a rating system with four levels of evidence: strong, moderate, limited, and no evidence. RESULTS: This review involved 51 trials and 6057 patients. Of these trials, 16 (31%) were of high quality. The pooled relative risk for global improvement after 1 week was 1.24 (95% confidence interval [CI] = 1.10-1.41), and for additional analgesic use was 1.29 (95% CI = 1.05-1.57), indicating a statistically significant but small effect in favor of nonsteroidal anti-inflammatory drugs as compared with a placebo. The results of the qualitative analysis showed that there is conflicting evidence (Level 3) that nonsteroidal anti-inflammatory drugs are more effective than paracetamol for acute low back pain, and that there is moderate evidence (Level 2) that nonsteroidal anti-inflammatory drugs are not more effective than other drugs for acute low back pain. There is strong evidence (Level 1) that various types of nonsteroidal anti-inflammatory drugs are equally effective for acute low back pain. CONCLUSIONS: The evidence from the 51 trials included in this review suggests that nonsteroidal anti-inflammatory drugs are effective for short-term symptomatic relief in patients with acute low back pain. Furthermore, there does not seem to be a specific type of nonsteroidal anti-inflammatory drug that is clearly more effective than others. Sufficient evidence on chronic low back pain still is lacking.

Adolescent↗