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At least 109 records · Page 6Linked to original sources
PubMed1999

[Review process of new oncology drug application in Japan--role of MD reviewer].

On the basis of discussion by the Committee for Drug Safety Ensuring Measures, the Japanese Ministry of Health and Welfare (MHW) has amended the Pharmaceutical Affairs Law and related laws, and is reforming its review system for approving new drugs. One of the most important changes in the review system is the establishment of Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) in July, 1997 under the National Institute of Health Sciences, a research institute under MHW. PMDEC, the Evaluation and Licensing Division at MHW and the Organization for Drug ADR Relief, R&D Promotion and Product Review (the Drug Organization) are in charge of drug approval, and reexamination and reevaluation applications. Before the reform new drug application reviews had been conducted mainly by the Central Pharmaceutical Affairs Council (CPAC). After the reform PMDEC, employing technical officials who have expertise in pharmacology, toxicology, biostatistics, clinical medicine, or other scientific fields, jointly review the applications with CPAC. The Evaluation and Licensing Division takes charge of administrative matters, such as final decisions on approvals, developing guidelines concerning the review process, international affairs, and regulatory instructions. During the early part of review the Drug Organization conducts a compliance review on the documents, which a sponsor submits with the approval application, and GCP inspection.

Antineoplastic Agents↗
PubMedDate not supplied

The facility site review process for MCOs: clinical versus nonclinical reviewers.

Managed care organizations (MCOs) conduct provider facility site reviews to promote quality standards in office practice operations and to comply with such regulating agencies as the Joint Commission, various payers, and the Michigan Department of Community Health and statutes such as the Michigan Occupational Safety and Health Act. The results of the facility site reviews are incorporated into the credentialing and recredentialing decision processes for individual practitioners and provider organizations. This study sought to compare the facility site reviews conducted by nurse reviewers who were experienced in quality management of managed care with site reviews conducted by nonclinical staff. In 9 of the 22 sites, the nurse reviewers' scores more accurately represented the primary care physicians' compliance with existing standards and regulations than did those reported by the nonclinical reviewers. This study supports the recommendation that facility site reviews be conducted by nurses experienced in the quality management of managed care.

Data Collection↗
PubMed2001

Reviewing the reviews. How strong is the evidence? How clear are the conclusions?

OBJECTIVES: The objectives of this paper were: a) to determine what can be learned from conclusions of systematic reviews about the evidence base of medicine; and b) to determine whether two readers draw similar conclusions from the same review, and whether these match the authors' conclusions. METHODS: Three methodologists (two per review) rated 160 Cochrane systematic reviews (issue 1, 1998) using pre-established conclusion categories. Disagreements were resolved by discussion to arrive at a consensual score for each review. Reviews' authors were asked to use the same categories to designate the intended conclusion. Interrater agreements were calculated. RESULTS: Interrater agreement between two readers was 0.68 and 0.72, and between readers and authors, 0.32. The largest categories assigned by methodologists were "positive effect" (22.5%), "insufficient evidence" (21.3%), and "evidence of no effect" (20.0%). The largest categories assigned by authors were "insufficient evidence" (32.4%), "possibly positive" (28.6%), and "positive effect" (26.7%). CONCLUSIONS: The number of reviews indicating that the modern biomedical interventions show either no effect or insufficient evidence is surprisingly high. Interrater disagreements suggest a surprising degree of subjective interpretation involved in systematic reviews. Where patterns of disagreement emerged between authors and readers, authors tended to be more optimistic in their conclusions than the readers. Policy implications are discussed.

Bibliometrics↗
PubMed2000

When reviews attack: ethics, free speech, and the peer review process.

The peer review process, whether formally applied in publication and grant review, or informally, such as exchange of ideas in scientific and professional newsgroups, has sparked controversy. Writers in this area agree that scholarly reviews that are inappropriate in tone are not uncommon. Indeed, commentators have suggested rules and guidelines that can be used to improve the review process and to make reviewers more accountable. In this paper, we examine the relevance and impact of ethical codes on the conduct of peer review. It is our contention that the peer review process can be improved, not by a new set of rules but through closer attention to the ethical principles to which we, as psychologists, already subscribe.

Canada↗
PubMed2005

Systematic reviews involving complementary and alternative medicine interventions had higher quality of reporting than conventional medicine reviews.

OBJECTIVE: To compare the quality of systematic reviews reported in English and in languages other than English, and to determine whether there are differences between conventional medicine (CM) and complementary and alternative medicine (CAM) reports. STUDY DESIGN AND SETTING: We used the Oxman and Guyatt (OG) scale to assess the quality of reporting in 130 systematic reviews: 50 were language-restricted, 32 were language-inclusive but only English-language (EL) trials contained (inclusive-EL), and 48 were language-inclusive and included trials published in languages other than English (inclusive-LOE). Of the 130 reviews, 105 addressed CM interventions and 25 addressed CAM interventions. RESULTS: Comparison of the systematic reviews showed that the quality of reporting and reporting characteristics are not affected by inclusion or exclusion of LOE; however, the quality of reporting of systematic reviews involving CAM interventions is higher than that of reviews focusing on CM interventions. CONCLUSION: Informal comparison of the OG scale with the data collected on quality assessments showed that the OG scale performs well overall but may not identify important differences in comprehensiveness of the search strategy and avoidance of bias in study selection. Further research is required to determine the best methods for assessing quality of systematic reviews and whether the effect of language restrictions is dependent on the type of intervention (CM or CAM).

Bias↗
PubMed1999

Development of the review quality instrument (RQI) for assessing peer reviews of manuscripts.

Research on the value of peer review is limited by the lack of a validated instrument to measure the quality of reviews. The aim of this study was to develop a simple, reliable, and valid scale that could be used in studies of peer review. A Review Quality Instrument (RQI) that assesses the extent to which a reviewer has commented on five aspects of a manuscript (importance of the research question, originality of the paper, strengths and weaknesses of the method, presentation, interpretation of results) and on two aspects of the review (constructiveness and substantiation of comments) was devised and tested. Its internal consistency was high (Cronbach's alpha 0.84). The mean total score (based on the seven items each scored on a 5-point Likert scale from 1 to 5) had good test-retest (Kw = 1.00) and inter-rater (Kw = 0.83) reliability. There was no evidence of floor or ceiling effects, construct validity was evident, and the respondent burden was acceptable (2-10 minutes). Although improvements to the RQI should be pursued, the instrument can be recommended for use in the study of peer review.

Humans↗
PubMed1995

Review of the reviewer.

Reviewers can disagree substantially when evaluating the same materials. For papers submitted to an editorial board, the Editor-in-Chief can suggest compromises. However, this is not the case in the normal abstract grading procedures for large meetings. If important discrepancies arise between reviewers, a review committee may propose corrective measures. However, this is only feasible for smaller meetings with a limited number of abstract submissions. In this study, when reviewing the same abstracts, a statistically significant correlation between reviewers was present in 15 instances and absent in 13 others. It would appear that some review of the reviewer is highly desirable and may prevent publication bias.

Abstracting and Indexing↗
PubMed2003

How objective are systematic reviews? Differences between reviews on complementary medicine.

Systematic reviews are considered the most reliable tool to summarize existing evidence. To determine whether reviews that address the same questions can produce different answers we examined systematic reviews of herbal medicine, homeopathy, and acupuncture taken from a previously established database. Information on literature searching, inclusion criteria, selection process, quality assessment, data extraction, methods to summarize primary studies, number of included studies, results and conclusions was compared qualitatively. Seventeen topics (eight on acupuncture, six on herbal medicines, three on homeopathy) had been addressed by 2-5 systematic reviews each. The number of primary studies in the reviews varied greatly within most topics. The most obvious reason for discrepancies between the samples was different inclusion criteria (in thirteen topics). Methods of literature searching may have contributed with some topics but the equivalence of the searches was difficult to assess. Differences were frequently observed in other methodological aspects, in results and in conclusions. This analysis shows that, at least in the three areas examined, systematic reviews often differ considerably. Readers should be aware that apparently minor decisions in the review process can have major impact.

Clinical Trials as Topic↗
PubMed1992

Hospital-reviewer relations and effective utilization review.

A survey of utilization review nurses revealed substantial variation in the relationships between these nurses and the hospitals at which they review cases. Hospitals providing reviewers with complete responses to questions were associated with high levels of utilization review compliance, which was a significant factor in explaining the savings associated with utilization review. Improving relations between hospitals and utilization reviewers may yield higher levels of utilization review compliance and significant cost savings.

Communication Barriers↗
PubMed1998

[Agreement and differences between reviewers in a peer review procedure].

In Germany the statutory pension insurance institutions have started a quality assurance programme. Our institute developed a peer review procedure for screening the process quality of rehabilitation care. The peer review was tested in a pilot study. Our article refers to the examination of interrater reliability, intrarater reliability and reviewer bias. First of all, experienced doctors were trained in reviewing reports routinely written by rehabilitation doctors at discharge of their patients. The peers had to judge on 56 process criteria belonging to six categories (e.g. case history). The reliability coefficients were calculated for the overall judgement of each category and the overall judgement of the process quality of rehabilitation care. The coefficients of interrater reliability and the coefficients of average intrarater reliability range from sufficient to good. Only few reviewers showed a general tendency to harsh or lenient rating. The objectivity of the tested peer review procedure seems definitely higher than in American studies of peer review of hospital charts.

Bias↗
PubMed2004

The art and science of reviewing manuscripts for orthopaedic journals: Part I. Defining the review.

The peer review process is integral to the functioning of all scientific journals and plays a pivotal role in the publication of new scientific material. Timeliness, freedom from bias, and proper review etiquette are essential for an effective review. Each type of scientific article demands a slightly different reviewing technique. Clinical research articles require that a proper question be asked and that the study methodology allows the question to be answered effectively. All studies dealing with human subjects need to be approved by the Institutional Review Board. Clinical review articles have specific criteria to determine how they should be constructed and when they should be published, whereas basic science research articles should be evaluated for their experimental method as well as the relevance of the conclusions to the data. Finally, case reports have an important place in the scientific literature, but the rationale for publishing any individual case needs to be clearly established.

Clinical Trials as Topic↗
PubMed2002

The role of the institutional review board in quality improvement: a survey of quality officers, institutional review board chairs, and journal editors.

PURPOSE: There has been growing concern about whether and when quality improvement activities require Institutional Review Board (IRB) review and informed consent. We sought to determine whether quality officers, IRB chairs, and journal editors share similar views about the role of IRB review and informed consent in quality improvement. METHODS: A survey consisting of six quality improvement scenarios detailing the development, implementation, and evaluation of a clinical practice guideline for the management of patients with acute myocardial infarction was mailed to all medical directors of quality and IRB chairpersons at hospitals with at least 400 beds that are members of the Council of Teaching Hospitals of the Association of American Medical Colleges. The same survey was mailed to the editors of all U.S. medical journals that appear in Abridged Index Medicus. RESULTS: Quality officers were less likely than IRB chairs to believe that IRB review was required for all but one of the scenarios. When a clinical practice guideline developed by a national specialty society was implemented locally and its effects evaluated by chart review and telephone calls to patients, 47% (44/94) of IRB chairs, 66% (25/38) of journal editors, but only 20% (20/100) of quality officers believed the activity should be subjected to IRB review. Among those who thought that IRB review was required, there were similar but less striking differences in the perceived need for informed consent. Agreement between quality officers and IRB chairs within the same institution was poor, ranging from 44% to 52% for three of the six scenarios. CONCLUSION: In light of the pressing need to improve quality while protecting the rights of patients, efforts should be supported to clarify the role of the IRB in quality improvement activities.

Attitude of Health Personnel↗
PubMed2000

A blind review and an informed review of interval breast cancer cases in the Limburg screening programme, the Netherlands.

OBJECTIVE: To investigate the proportion of interval breast cancers that could have been detected at the previous screening examination, and to gain more insight into the characteristics of these tumours. SETTING: Breast cancer screening programme in mid- and southern Limburg, the Netherlands. METHOD: Firstly, previous screening mammograms of 92 interval cancer cases were blindly reread by the radiologists from two different units as part of their daily screening workload. Secondly, a separate informed review was conducted, in which all of the cases (except for two) were subclassified into four categories: screening error; minimal signs; radiologically occult both at previous screening and at diagnosis; or radiologically occult at previous screening. Trends in recall rates and false and true positive rates were calculated to study potential changes during and after the blind review. RESULTS: In the blind review, 15% of the interval cancers were detected in both rereadings and 21% in one rereading. In the informed review, 25% were classified as a screening error and 24% as minimal signs present; 74% of the cases classified as a screening error had been recalled at least once in the blind review. Recall rates and false positive rates in daily screening practice increased significantly during and after the study period. CONCLUSIONS: About one third of the interval cancers could have been detected in the previous screening round. In order to diminish the number of avoidable interval cancers, review and classification of interval cancers is an important tool for continuing the education of screening radiologists. Therefore, further development of review training procedures is necessary.

Aged↗
PubMedDate not supplied

Quality control of the autopap screening system employed as a primary screening device: rapid review of smears coded as no further review.

AIMS AND BACKGROUND: Automated reading of smears is increasingly used in cervical screening, and quality control procedures to check its performance are required. The aim of the present study was to evaluate the usefulness of rapid review of all smears coded as "no further review" (NFR) by the AutoPap system as a quality control procedure. METHODS: From 2002-2005, 153,269 smears were processed by AutoPap at the Centro per lo Studio e la Prevenzione Oncologica of Florence, Italy, and 24,503 (15.9%) were coded as NFR. All NFR smears underwent immediate rapid review by expert readers. RESULTS: Sixty-five of 118 NFR cases reviewed as ASCUS-R complied to recommended 6 months cytology, and 25 of 30 NFR cases reviewed as ASCUS-SIL or more severe accepted immediate colposcopy. As a result of such assessment, one single case of microinvasive carcinoma was detected in a woman aged 34 years: NFR smear had been reviewed as AGCUS, was followed by repeat AGCUS cytology and repeat negative colposcopy, and finally underwent conization. CONCLUSIONS: NFR report at AutoPap was associated with an extremely high negative predictive value, which might suggest using AutoPap as a primary screening tool, with NFR report prompting a "return to screening" recommendation. Rapid review of NFR smears is not recommended as a quality control measure for the negligible yield of high-grade lesions detected.

Adult↗
PubMed1983

Medicare program; administrator's review of Provider Reimbursement Review Board decisions-HCFA. Final rule.

These regulations set forth several changes in the procedures relating to the Administrator's review of Provider Reimbursement Review Board (the Board) decisions. These regulations: (1) Specify procedures and criteria for the Administrator's review of Board decisions: (2) authorize the Administrator to remand cases to the Board: (3) specify that the Administrator may review a Board's decision concerning jurisdiction to hear a case; and (4) clarify the time period available to a provider seeking judicial review if the Administrator declines to review a Board decision. The purpose of this final rule is to inform providers of criteria used by the Administrator in reviewing decisions and to clarify procedures and policies that have been identified through experience as subject to differing interpretations.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed1999

Drug utilization reviews of oral quinolone, cephalosporin, and macrolide use in nonacute care: a systematic review.

Drug utilization review (DUR) is a tool for monitoring the appropriateness of physicians' prescribing patterns. The present systematic overview was undertaken to determine the extent of appropriate use of oral quinolones, cephalosporins, and macrolides in nonacute-care settings in North America reported in published DUR studies. Potentially relevant DURs conducted since 1987 were retrieved from an electronic search of 6 databases (augmented by manual searches of bibliographies of appropriate articles) and from personal communications with local experts. Independent reviewers applied objective criteria to select the DURs for inclusion. Quality assessments were performed by 4 independent reviewers using the Edmonton Quality Assessment Tool for Drug Utilization Reviews, an instrument developed to assess the potential for systematic bias in a DUR. Data from the studies included were abstracted independently by 2 reviewers using a standard data-collection form. Twelve of 587 (2.0%) articles met the inclusion criteria. Eight studies targeted the appropriateness of prescriptions for ciprofloxacin (appropriateness range, 5% to 95%), 3 included cephalosporins (range, 0% to 100%), and 2 examined erythromycin (40%). There were 2 primary reasons for a rating of inappropriate: (1) the prescription was not first-line therapy, or (2) there was insufficient documentation in the patient record. The designation inappropriate did not mean that the drug did not benefit the patient. Of the 4 intervention-based DURs, 1 study showed a significant improvement in appropriate use. Because of heterogeneity in study design, delivery of interventions, and outcome assessment, a pooled estimate of effect was not derived. Four studies estimated the cost of inappropriate prescribing to the institutional study site, which ranged from $20,500 to $173,359 annually; however, these estimates cannot be generalized because of various limitations. When the 12 studies were assessed for methodologic quality, 1 study was rated as high, 7 as moderate, and 4 as low. Levels of prescribing appropriateness reported in the DUR literature should be interpreted cautiously. The DUR studies included in this review varied greatly in the methodologic rigor applied to sample selection, standardized data collection, application of standardized screening criteria, and validated data analysis.

Bacterial Infections↗
PubMed2005

Effects of continuing medical education on improving physician clinical care and patient health: a review of systematic reviews.

OBJECTIVES: The objective of physician continuing medical education (CME) is to help them keep abreast of advances in patient care, to accept new more-beneficial care, and discontinue use of existing lower-benefit diagnostic and therapeutic interventions. The goal of this review was to examine effectiveness of current CME tools and techniques in changing physician clinical practices and improving patient health outcomes. METHODS: Results of published systematic reviews were examined to determine the spectrum from most- to least-effective CME techniques. We searched multiple databases, from 1 January 1984 to 30 October 2004, for English-language, peer-reviewed meta-analyses and other systematic reviews of CME programs that alter physician behavior and/or patient outcomes. RESULTS: Twenty-six reviews met inclusion criteria, that is, were either formal meta-analyses or other systematic reviews. Interactive techniques (audit/feedback, academic detailing/outreach, and reminders) are the most effective at simultaneously changing physician care and patient outcomes. Clinical practice guidelines and opinion leaders are less effective. Didactic presentations and distributing printed information only have little or no beneficial effect in changing physician practice. CONCLUSIONS: Even though the most-effective CME techniques have been proven, use of least-effective ones predominates. Such use of ineffective CME likely reduces patient care quality and raises costs for all, the worst of both worlds.

Clinical Competence↗
PubMed2005

Which resources should be used to identify RCT/CCTs for systematic reviews: a systematic review.

BACKGROUND: Systematic reviewers seek to comprehensively search for relevant studies and summarize these to present the most valid estimate of intervention effectiveness. The more resources searched, the higher the yield, and thus time and costs required to conduct a systematic review. While there is an abundance of evidence to suggest how extensive a search for randomized controlled trials (RCTs) should be, it is neither conclusive nor consistent. This systematic review was conducted in order to assess the value of different resources to identify trials for inclusion in systematic reviews. METHODS: Seven electronic databases, four journals and Cochrane Colloquia were searched. Key authors were contacted and references of relevant articles screened. Included studies compared two or more sources to find RCTs or controlled clinical trials (CCTs). A checklist was developed and applied to assess quality of reporting. Data were extracted by one reviewer and checked by a second. Medians and ranges for precision and recall were calculated; results were grouped by comparison. Meta-analysis was not performed due to large heterogeneity. Subgroup analyses were conducted for: search strategy (Cochrane, Simple, Complex, Index), expertise of the searcher (Cochrane, librarian, non-librarian), and study design (RCT and CCT). RESULTS: Sixty-four studies representing 13 electronic databases met inclusion criteria. The most common comparisons were MEDLINE vs. handsearching (n = 23), MEDLINE vs. MEDLINE+handsearching (n = 13), and MEDLINE vs. reference standard (n = 13). Quality was low, particularly for the reporting of study selection methodology. Overall, recall and precision varied substantially by comparison and ranged from 0 to 100% and 0 to 99%, respectively. The trial registries performed the best with median recall of 89% (range 84, 95) and median precision of 96.5% (96, 97), although these results are based on a small number of studies. Inadequate or inappropriate indexing was the reason most cited for missing studies. Complex and Cochrane search strategies (SS) performed better than Simple SS. CONCLUSION: Multiple-source comprehensive searches are necessary to identify all RCTs for a systematic review, although indexing needs to be improved. Although trial registries demonstrated the highest recall and precision, the Cochrane SS or a Complex SS in consultation with a librarian are recommended. Continued efforts to develop CENTRAL should be supported.

Databases, Bibliographic↗