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At least 73 records · Page 4Linked to original sources

Impact of initial quality control review on study outcome in lung and head/neck cancer studies--review of the Radiation Therapy Oncology Group experience.

The Radiation Therapy Oncology Group (RTOG) initiated cooperative clinical trials in 1971. In 1978, RTOG developed a formalized program of Quality Control (QC) divided into initial and final phases. The initial review process consisted of two steps. The first phase of review is an evaluation performed by a radiation oncologist to verify treatment plan and field borders. The second portion of the initial review process originally consisted of dosimetry calculation verification based on machine data provided by the regional Radiological Physics Center and treatment planning data provided by the accessioning institution. Between 1978 and December 31, 1987, a total of 11,343 cases in 96 RTOG protocols, excluding particle studies, underwent initial review. Of this number, 2227 patients were entered in lung cancer studies and 1341 patients were entered in head/neck cancer studies. Initial review was carried out in 2089 (93.8%) of the lung cancer cases. Missing or delayed data accounted for 138 (6.2%) cases not reviewed initially. In head/neck cancer trials, 1251 (93.2%) received initial review and 90 (6.8%) did not. Our findings suggest that there are sharply defined but long lasting learning experiences involved in clinical trial participation. Consideration may be given to modifying the initial review process to use random sampling of cases accessioned by experienced investigators in ongoing clinical trials and to continuing the total case evaluation on all new studies and cases entered by inexperienced investigators or investigators/institutions with unsatisfactory performance. Recommendations regarding initial review of other sites will await evaluation of the impact of initial review on those sites.

Head and Neck Neoplasms↗

Radiologist review versus group peer review of claimed responses in a phase II study on high-dose ifosfamide in advanced soft tissue sarcomas of the adult: a study of the EORTC Soft Tissue and Bone Sarcoma Group.

The Soft Tissue and Bone Sarcoma Group (STBSG) of the EORTC ran a phase II study to assess the therapeutic activity of high-dose ifosfamide in patients with advanced soft tissue sarcomas by means of response rate (RR). Investigators claiming a response submitted the relevant chest radiographs (CXR) or scans to two other members of the STBSG for peer review. The reviewers completed a questionnaire indicating overall response or reasons for rejecting the claimed responses. An independent radiologist also reviewed the cases and he was blinded to the results of the peer review until the study was concluded. Twenty-two patients were reviewed by the radiologist and peer review, and the completed questionnaires were retrospectively reviewed. Two differences were noted, one partial responder (PR) was regarded as stable disease by the radiologist and one PR by peer review was determined a complete response by the radiologist. The radiologist found subsequent evidence of progressive disease in three patients who initially showed a PR, whilst the review group noted only one. This study suggests peer review in this tumor type is a satisfactory method of achieving an accurate, objective RR.

Adolescent↗

Evaluation of cardiovascular grant-in-aid applications by peer review: influence of internal and external reviewers and committees.

OBJECTIVE: To determine what factors of the peer review process played a significant role in the assignment of scores for scientific merit by a major cardiovascular research finding agency. Specific variables studied included scores of internal and external reviewers, committee assignment and year of application. DESIGN AND SETTING: Retrospective analysis of research proposals submitted to the Heart and Stroke Foundation of Ontario from 1990 to 1994. SUBJECTS: Of a total database of 804 grant-in-aid (operating or project) proposals submitted to the Heart and Stroke Foundation of Ontario from 1990 to 1994, 779 had complete data and were included in the study. Variables analyzed were scores of internal and external reviewers, final committee score, committee assignment and year of application. MAIN RESULTS: There was poor correlation (r = 0.113) between external reviewers of grant proposals and only slightly better correlation between internal reviewers (r = 0.331). When mean internal and external scores were analyzed, correlation improved (r = 0.451) but agreement beyond chance was only moderate (weighed Cohen's kappa = 0.532). Regression analysis established that mean internal score had a greater impact on final committee score (r2 = 0.607, P < 0.001) than mean internal score (r2 = 0.348, P < 0.001). When review committee was entered as a dummy variable into a regression statement, it was statistically significant (P < 0.001) but explained less than 8% of variance in the final committee score. Mean scores showed a small 'upward creep' over the five-year period but explained less than 4% of variance in final committee score (r2 = 0.039, P < 0.001). CONCLUSIONS: In the peer review system studied, the scores of internal reviewers were more closely correlated to final committee score for scientific merit than those of external reviewers. Nevertheless, final committee scores were significantly different from either internal or external scores, suggesting that the process of committee discussion is an important, and highly influential, step in the peer review process.

Canada↗

Teaching clinical skills through videotape review: a randomized trial of group versus individual reviews.

BACKGROUND: Video review is a valuable educational tool for teaching communication skills. Many studies have demonstrated its efficacy with individual learners, but few studies have addressed its use in a group format. PURPOSE: To assess the educational benefits of group versus individual video review of standardized patient encounters through the evaluations of 4th-year students at the Albert Einstein College of Medicine. METHODS: Students (128) who participated in a 7-station, standardized patient, clinical competency exam were randomly assigned to an individual or small group video review of selected segments of these encounters in 2000-2001. Students filled out an anonymous 13-item questionnaire assessing the experience and provided open-ended responses. RESULTS: With both review formats, most students had a positive learning experience (80%), found it less stressful than they expected (67%), and would not have preferred to do the review the other way (84%). Students randomized to individual reviews had a significantly higher level of satisfaction with the amount of time for the session (91% vs. 78%, p < .05) and the amount of feedback they received (95% vs. 79%, p = .01) and were more likely to view the session as a positive learning experience (88% vs. 73%, p < .05). Students in the individual review format were more likely to choose self-assessed weak segments (63% vs. 49%, p = .01). Students' comments indicated that they appreciated the value of peer review in a group setting. CONCLUSIONS: Although both group reviews and individual reviews of videotaped standardized patient encounters were received well by the students, there were several statistical differences in favor of the individual format.

Adult↗

A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval.

BACKGROUND AND OBJECTIVES: To characterize the impact of multiple Institutional Review Board (IRB) reviews on multicenter observational research studies, and identify strategies for overcoming the identified challenges. MATERIALS AND METHODS: Using PubMed, we identified empirical studies, anecdotal reports, and opinion pieces addressing the process of obtaining initial IRB approval for multicenter clinical trials and observational studies. We also reviewed relevant information from federal and other national sources. RESULTS: A total of 40 peer-reviewed articles were synthesized, plus six reports from commissions or other key sources. These sources identified numerous challenges that researchers may encounter when multicenter studies undergo review by multiple IRBs, such as added time for initial review and approval and different requirements across IRBs. Strategies to alleviate these challenges include planning to accommodate multiple reviews and determining upfront whether certain variations to study protocols are tolerable across sites. Many researchers and commissions have proposed comprehensive reforms, such as centralized review for multicenter projects. CONCLUSION: Policy-makers, researchers, and IRBs should convene to specifically discuss optimal approaches for multicenter review. However, until structural changes are implemented, observational researchers should develop and implement strategic plans for obtaining IRB approval in multicenter studies, including adopting models successfully employed by clinical trials.

Epidemiologic Research Design↗

A systematic review of systematic reviews and meta-analyses of animal experiments with guidelines for reporting.

To maximize the findings of animal experiments to inform likely health effects in humans, a thorough review and evaluation of the animal evidence is required. Systematic reviews and, where appropriate, meta-analyses have great potential in facilitating such an evaluation, making efficient use of the animal evidence while minimizing possible sources of bias. The extent to which systematic review and meta-analysis methods have been applied to evaluate animal experiments to inform human health is unknown. Using systematic review methods, we examine the extent and quality of systematic reviews and meta-analyses of in vivo animal experiments carried out to inform human health. We identified 103 articles meeting the inclusion criteria: 57 reported a systematic review, 29 a systematic review and a meta-analysis, and 17 reported a meta-analysis only. The use of these methods to evaluate animal evidence has increased over time. Although the reporting of systematic reviews is of adequate quality, the reporting of meta-analyses is poor. The inadequate reporting of meta-analyses observed here leads to questions on whether the most appropriate methods were used to maximize the use of the animal evidence to inform policy or decision-making. We recommend that guidelines proposed here be used to help improve the reporting of systematic reviews and meta-analyses of animal experiments. Further consideration of the use and methodological quality and reporting of such studies is needed.

Animal Experimentation↗

Comparison of reports of randomized controlled trials and systematic reviews in surgical journals: literature review.

OBJECTIVES: Randomized controlled trials and systematic reviews of such trials are the gold standard for assessing the effectiveness of interventions. There have been concerns about the anecdotal evidence underpinning many of the interventions used and introduced into surgical care. The American College of Surgeons has prioritized the need for more trials and systematic reviews of trials. To investigate the assertion that the methodological quality of studies conducted in surgery is in general poor and to assess the possible impact of new policy developments in the US, we sought to compare the number and proportion of published randomized controlled trials and systematic reviews in the leading two US and UK general surgical journals. Two reviewers systematically and independently hand searched all issues of these journals over a 12-month period to identify randomised controlled trials and systematic reviews. DESIGN: Systematic searching and independent abstraction of data from all volumes of the top two general surgical journals published in the USA and the UK in 2004. SETTING: 519 original reports in UK journals and 616 original reports in USA journals. MAIN OUTCOME MEASURES: Number and proportion of randomized controlled trials and systematic reviews. RESULTS: Overall, the proportion of randomized controlled trials in all four journals was 5.6% (95% confidence interval [CI] 4.4-7.0) and 5.2% (95% CI 4.1-6.7) for systematic reviews. For journals published in the UK 29/519 (5.6%) of the publications were reports of randomized controlled trials, and for the USA journals this figure was 34/616 (5.5%); odds ratio [OR]=0.99, 95%CI 0.6-1.6; P=0.96. Systematic reviews were significantly more commonly reported in the UK journals: UK 37/519 (7.1%) versus USA 22/616 (3.6%); OR=0.48, 95%CI 0.3-0.8; P<0.01. CONCLUSIONS: The concerns expressed almost a decade ago remain valid: there are still very few reports of randomized controlled trials and systematic reviews published in leading USA and UK surgical journals, with relatively little difference between these countries in the proportion of reported studies employing these designs. The American College of Surgeons initiative has yet to make an impact.

Biomedical Research↗

A comparison of the quality of Cochrane reviews and systematic reviews published in paper-based journals.

This study set out to compare Cochrane reviews and reviews published in paper-based journals. Two assessment tools were used to collect the data, a 23-item checklist developed by Sacks and a nine-item scale developed by Oxman. Cochrane reviews were found to be better at reporting some items and paper-based review at reporting others. The overall quality was found to be low. This represents a serious situation because clinicians, health policy makers, and consumers are often told that systematic reviews represent "the best available evidence." In the period since this study, the Cochrane Collaboration has taken steps to improve the quality of its reviews through, for example, more thorough prepublication refereeing, developments in the training and support offered to reviewers, and improvements in the system for postpublication peer review. In addition, the use of evidence-based criteria (i.e., the QUOROM statement) for reporting systematic reviews may help further to improve their quality.

Evidence-Based Medicine↗

Of mites and men: reference bias in narrative review articles: a systematic review.

BACKGROUND: Citations in scientific articles may tend to favor the views presented. We studied whether there is such reference bias in narrative review articles that discuss interventions against house dust mites for people with asthma. DESIGN: Systematic review of reviews identified in a Medline search that expressed an opinion about the clinical effects of physical or chemical intervention methods. MAIN OUTCOME MEASURE: Positive bias was judged to have occurred if the reference list contained a higher proportion of trial references with significant results than among all trials available to the authors (published 2 years or more prior to the review). RESULTS: Seventy reviews were included, of which 63 (90%) recommended physical interventions. Forty-six reviews had trial references, 4 of these only to chemical interventions. In the remaining 42 reviews, reference bias was detected (P=2 x 10-8). The most quoted trial had only 7 patients per group, its claimed significant result was probably erroneous, and it did not report a clinical outcome. Intervention recommendations were often based on nonrandomized evidence, and the most quoted nonrandomized controlled study had included only 10 patients per group but claimed very positive results. CONCLUSION: The narrative review articles were severely biased, and their positive intervention recommendations are at variance with the systematic Cochrane Review on this topic and a recent very large trial of physical intervention, both of which failed to find an effect.

Asthma↗

A peer review of a peer review organization.

Under Medicare, one of the federally required objectives of peer review organizations is to reduce inappropriate and unnecessary admissions. We reevaluated 32 admissions approved and 32 denied by the Arizona peer review organization, Health Services Advisory Group (HSAG), in a "blind" manner to determine whether practicing physicians in the community agree with the local peer review organization. Overall, physicians at the Scottsdale Memorial Hospital (SMH) approved 72% of HSAG-approved and denied 61% of HSAG-denied admissions. Of the 64 admissions, 3 or 4 of 4 reviewers (2 physicians and 2 nurses) agreed with the HSAG decision in 38 (59%), but 2 or more reviewers disagreed in the other 26 (41%). Disagreement between the 2 physicians occurred in 48% of the cases and disagreement between the 2 nurses in 33%. Even among admissions denied by SMH physician reviewers, the physicians would have admitted 23% of those patients under similar circumstances. In 28% of the HSAG-denied admissions, the reviewing physicians thought that the patients' health care would have been compromised if the admissions had not taken place. Despite well-defined criteria for the appropriateness of hospital admissions, the review process remains subjective, with much disagreement between peer review organizations and practicing physicians.

Aged↗

The application of artificial intelligence in healthcare practice: A mapping review of systematic reviews.

Artificial intelligence (AI) is rapidly transforming healthcare practice, with growing evidence supporting its use in diagnosis, prognosis, treatment planning, and operational decision-making. The proliferation of systematic reviews in recent years underscores the need for an updated synthesis of the literature to inform research, policy, and practice. We searched PubMed, Web of Science, Scopus, IEEE Xplore, and CINAHL for systematic reviews and meta-analyses published between 2019 and February 2026. Eligible reviews focused on AI applications in healthcare practice, were peer-reviewed, and written in English. A total of 368 reviews met the inclusion criteria. Publication volume increased steadily, peaking in 2025. AI research was concentrated in high-density domains, such as radiology, oncology, and critical care. Across reviews, diagnostic imaging, electronic health record (EHR) data, and biomarkers/laboratory results accounted for 68% of training data sources, though newer data types, such as wearable device and sensor data, emerged from 2022 onward. Diagnosis, prognosis, and treatment comprised over 80% of AI applications, with novel uses emerging in recent years, such as AI-assisted clinical documentation (e.g., ambient documentation tools) and patient education. Ethical concerns were reported in 78.5% of reviews, with privacy, model accuracy, data and algorithmic bias, and explainability as recurrent themes. The proportion of reviews reporting ethical concerns increased from 2021 to 2025. AI applications in healthcare are expanding in scope, diversifying in data sources, and evolving toward novel clinical and operational uses. The human-centered AI or augmented intelligence paradigm, integrating computational precision with clinical expertise, holds significant promise but will require parallel advances in governance, regulatory frameworks, and ethical oversight to ensure safe adoption.

Artificial Intelligence↗

Scientific composition and review of manuscripts for publication in peer-reviewed dental journals.

This article provides an extensive tutorial for writers and reviewers involved with the preparation and evaluation of manuscripts submitted for publication in dental journals. The contents were compiled from the Instructions for Authors printed in various peer-reviewed dental journals and from feedback from 10 workshops conducted for the Editorial Review Board of the Journal of Prosthetic Dentistry. The 10 major sections of a scientific manuscript are reviewed in detail in terms of content, format, and common errors; examples of good content are provided. The review process is described, and instructions on conducting fair and expeditious manuscript evaluations are provided for reviewers. In addition, a number of special topics are addressed, including potential conflicts of interest for an author, institutional review of experiments that involve human subjects or animals, and the reproduction of photographs and other images in color versus black and white. In summary, this article presents key guidelines to ensure compliance with the principles of sound scientific writing and the expeditious review of manuscripts prepared for publication in peer-reviewed dental journals.

Dental Research↗

Reproducibility of peer review in clinical neuroscience. Is agreement between reviewers any greater than would be expected by chance alone?

We aimed to determine the reproducibility of assessments made by independent reviewers of papers submitted for publication to clinical neuroscience journals and abstracts submitted for presentation at clinical neuroscience conferences. We studied two journals in which manuscripts were routinely assessed by two reviewers, and two conferences in which abstracts were routinely scored by multiple reviewers. Agreement between the reviewers as to whether manuscripts should be accepted, revised or rejected was not significantly greater than that expected by chance [kappa = 0.08, 95% confidence interval (CI) -0.04 to -0.20] for 179 consecutive papers submitted to Journal A, and was poor (kappa = 0.28, 0.12 to 0. 40) for 116 papers submitted to Journal B. However, editors were very much more likely to publish papers when both reviewers recommended acceptance than when they disagreed or recommended rejection (Journal A, odds ratio = 73, 95% CI = 27 to 200; Journal B, 51, 17 to 155). There was little or no agreement between the reviewers as to the priority (low, medium, or high) for publication (Journal A, kappa = -0.12, 95% CI -0.30 to -0.11; Journal B, kappa = 0.27, 0.01 to 0.53). Abstracts submitted for presentation at the conferences were given a score of 1 (poor) to 6 (excellent) by multiple independent reviewers. For each conference, analysis of variance of the scores given to abstracts revealed that differences between individual abstracts accounted for only 10-20% of the total variance of the scores. Thus, although recommendations made by reviewers have considerable influence on the fate of both papers submitted to journals and abstracts submitted to conferences, agreement between reviewers in clinical neuroscience was little greater than would be expected by chance alone.

Abstracting and Indexing↗

A statistical model validating triage for the peer review process: keeping the competitive applications in the review pipeline.

Triage of grant application at the National Institutes of Health (NIH) is a process whereby an initial screening of applications by a scientific peer review group eliminates applications that are not competitive for awards. The process of application triage has been limited to those applications submitted to the NIH in response to an RFA (Request for Applications). A hypergeometric model was developed to determine the extent to which five, six, seven, or eight member triage teams or subsets of 12-to-20 member full committees could provide a statistically defensible triage decision. Although the intent of triage is to remove from review those applications that are noncompetitive, the model was weighted in favor of the applicant to minimize the likelihood that highly competitive applications would be eliminated. Within the assumptions and rules developed, it was determined that there was little likelihood that the latter would occur. For example, in the worst case scenario, the greatest probability that a highly competitive application would be knocked out of competition is P < or = 0.014 in the case of a five-member triage subset of a 20-member committee. Using the latter case, the model was tested on a set of 73 applications that were submitted to the National Cancer Institute for action at the February 1993 National Cancer Advisory Board. The model selected for triage required that each application be assigned to five reviewers, that each reviewer be blinded to the review assignments of the other reviewers, and that four noncompetitive votes be registered to triage out an application. Each of 19 applications received four to five noncompetitive votes, and were triaged out of the review process. The remaining 54 applications were then reviewed according to the usual NIH review process. Four of the applications received three noncompetitive triage votes each and were either rated as not recommended for further consideration (NRF, n = 2)) or received priority scores > or = 250 (n = 2) (The smaller the priority score the better the technical merit). Thirteen of the 53 applications received two noncompetitive votes. Of the latter, two were not recommended for further consideration and the remaining 11 received priority scores between in excess of 200. The distribution of competitive applications was such that funding was limited to those applications with priority scores of less than 190. Thus, the data suggest that the conservative model is valid such that the likelihood of eliminating a highly competitive application from consideration for funding is remotely small.(ABSTRACT TRUNCATED AT 400 WORDS)

Competitive Bidding↗

Ethics review for sale? Conflict of interest and commercial research review boards.

Research review boards, established to protect the rights and welfare of human research subjects, have to ensure that conflicts of interest do not interfere with the ethical conduct of medical research. Private, commercial review boards, which increasingly review research protocols, are themselves affected by a structural conflict of interest. Within the regulatory setting, procedural conflict-of-interest rules are essential because of the absence of clear substantive rules in research review and the reliance on the fairness and good judgment of institutional review board members. Current guidelines and regulations lack adequate conflict-of-interest rules and provide insufficient details on the substantive rules. Because commercial review boards are similar to administrative courts and tribunals, rules of administrative law on bias are applied to determine when a conflict of interest jeopardizes the purposes of research review; administrative law has always judged financial conflicts of interest severely. The structure of private review tends to breach a core principle of administrative law and procedural justice. Reform of the research review system will reinforce public trust in the process.

Canada↗

Current status of biomedical book reviewing: Part III. Duplication patterns in biomedical book reviewing.

This is the third part of a comprehensive, quantitative study of biomedical book reviewing. The data base of the total project was built from statistics of 3,347 reviews of 2,067 biomedical books appearing in all 1970 issues of fifty-four reviewing journals. This part of the study explores the duplication patterns in book reviewing among these media. It is found that 35.17% (727 books) of the 2,067 titles were reviewed more than once in 1970, these titles accounting for 2,007 of the total of 3,347 reviews. For the most part, reviews of the most frequently reviewed titles appeared in such journals as British Medical Journal, Annals of Internal Medicine, Lancet, Journal of the American Medical Association, and New England Journal of Medicine. These five journals covered 93.53% of the 727 books reviewed more than once in 1970.

Biology↗

The Cochrane Collaboration Stroke Review Group. Meeting the need for systematic reviews in stroke care.

BACKGROUND: There is a pressing need to identify which interventions are definitely effective in the prevention of stroke and in the treatment and rehabilitation of stroke patients, which interventions are definitely ineffective, and which interventions require further research. This information is most reliably obtained from reviewing all the available evidence from randomized controlled trials in a systematic way. SUMMARY OF COMMENT: There have been many (at least 8000) randomized controlled trials relevant to stroke. It would be difficult for any one individual to keep track of all these trials, and therefore most clinicians, therapists, and researchers are dependent, to some degree, on reviews of this literature. However, most current reviews are unsystematic and tend to be either incomplete or biased, so that their recommendations can be seriously flawed. Until now there has been no attempt to systematically identify all randomized controlled trials relevant to stroke (including subarachnoid hemorrhage), to review the data they contain, and to keep these reviews up-to-date in the light of new evidence. The Stroke Review Group has now been established within the Cochrane Collaboration to try to perform these tasks. There are presently 40 collaborators from 13 countries working on approximately 25 reviews. CONCLUSIONS: Identifying and reviewing all randomized controlled trials relevant to stroke should bring important benefits to patients and all those involved in purchasing or providing care for patients with stroke. The Cochrane Collaboration Stroke Review Group has started this process and would welcome help from anyone interested in collaborating in this enormous task.

Bias↗