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How do authors of systematic reviews deal with research malpractice and misconduct in original studies? A cross-sectional analysis of systematic reviews and survey of their authors.

ABSTRACT: To study whether systematic reviewers apply procedures to counter-balance some common forms of research malpractice such as not publishing completed research, duplicate publications, or selective reporting of outcomes, and to see whether they identify and report misconduct.Cross-sectional analysis of systematic reviews and survey of their authors.118 systematic reviews published in four journals (Ann Int Med, BMJ, JAMA, Lancet), and the Cochrane Library, in 2013.Number (%) of reviews that applied procedures to reduce the impact of: (1) publication bias (through searching of unpublished trials), (2) selective outcome reporting (by contacting the authors of the original studies), (3) duplicate publications, (4) sponsors' and (5) authors' conflicts of interest, on the conclusions of the review, and (6) looked for ethical approval of the studies. Number (%) of reviewers who suspected misconduct are reported. The procedures applied were compared across journals.80 (68%) reviewers confirmed their data. 59 (50%) reviews applied three or more procedures; 11 (9%) applied none. Unpublished trials were searched in 79 (66%) reviews. Authors of original studies were contacted in 73 (62%). Duplicate publications were searched in 81 (69%). 27 reviews (23%) reported sponsors of the included studies; 6 (5%) analysed their impact on the conclusions of the review. Five reviews (4%) looked at conflicts of interest of study authors; none of them analysed their impact. Three reviews (2.5%) looked at ethical approval of the studies. Seven reviews (6%) suspected misconduct; only 2 (2%) reported it explicitly. Procedures applied differed across the journals.Only half of the systematic reviews applied three or more of the six procedures examined. Sponsors, conflicts of interest of authors and ethical approval remain overlooked. Research misconduct is sometimes identified, but rarely reported. Guidance on when, and how, to report suspected misconduct is needed.

SUBMITTER: Elia N

PROVIDER: S-EPMC4785311 | biostudies-other | 2016 Mar

REPOSITORIES: biostudies-other

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Project description:BACKGROUND:Despite the growing reputation and subject coverage of the Cochrane Database of Systematic Reviews, many systematic reviews continue to be published solely in paper-based health care journals. This study was designed to determine why authors choose to publish their systematic reviews outside of the Cochrane Collaboration and if they might be interested in converting their reviews to Cochrane format for publication in the Cochrane Database of Systematic Reviews. METHODS:Cross-sectional survey of Australian primary authors of systematic reviews not published on the Cochrane Database of Systematic Reviews identified from the Database of Abstracts of Reviews of Effectiveness. RESULTS:We identified 88 systematic reviews from the Database of Abstracts of Reviews of Effectiveness with an Australian as the primary author. We surveyed 52 authors for whom valid contact information was available. The response rate was 88 per cent (46/52). Ten authors replied without completing the survey, leaving 36 valid surveys for analysis. The most frequently cited reasons for not undertaking a Cochrane review were: lack of time (78%), the need to undergo specific Cochrane training (46%), unwillingness to update reviews (36%), difficulties with the Cochrane process (26%) and the review topic already registered with the Cochrane Collaboration (21%). (Percentages based on completed responses to individual questions.) Nearly half the respondents would consider converting their review to Cochrane format. Dedicated time emerged as the most important factor in facilitating the potential conversion process. Other factors included navigating the Cochrane system, assistance with updating and financial support. Eighty-six per cent were willing to have their review converted to Cochrane format by another author. CONCLUSION:Time required to complete a Cochrane review and the need for specific training are the primary reasons why some authors publish systematic reviews outside of the Cochrane Collaboration. Encouragingly, almost half of the authors would consider converting their review to Cochrane format. Based on the current number of reviews in the Database of Abstracts of Reviews of Effectiveness, this could result in more than 700 additional Cochrane reviews. Ways of supporting these authors and how to provide dedicated time to convert systematic reviews needs further consideration.

Project description:Synthesizing outcomes of underreported primary studies can pose a serious threat to the validity of outcomes and conclusions of systematic reviews. To address this problem, the Cochrane Collaboration recommends reviewers to contact authors of eligible primary studies to obtain additional information on poorly reported items. In this protocol, we present a cross-sectional study and a survey to assess (1) how reviewers of new Cochrane intervention reviews report on procedures and outcomes of contacting of authors of primary studies to obtain additional data, (2) how authors reply, and (3) the consequences of these additional data on the outcomes and quality scores in the review. All research questions and methods were pilot tested on 2 months of Cochrane reviews and were subsequently fine-tuned.Eligibility criteria are (1) all new (not-updates) Cochrane intervention reviews published in 2016, (2) reviews that included one or more primary studies, and (3) eligible interventions refer to contacting of authors of the eligible primary studies included in the review to obtain additional research data (e.g., information on unreported or missing data, individual patient data, research methods, and bias issues). Searching for eligible reviews and data extraction will be conducted by two authors independently. The cross-sectional study will primarily focus on how contacting of authors is conducted and reported, how contacted authors reply, and how reviewers report on obtained additional data and their consequences for the review.The same eligible reviews for the cross-sectional study will also be eligible for the survey. Surveys will be sent to the contact addresses of these reviews according to a pre-defined protocol. We will use Google Forms as our survey platform. Surveyees are asked to answer eight questions. The survey will primarily focus on the consequences of contacting authors of eligible primary studies for the risk of bias and Grading of Recommendations, Assessment, Development and Evaluation scores and the primary and secondary outcomes of the review.The findings of this study could help improve methods of contacting authors and reporting of these procedures and their outcomes. Patients, clinicians, researchers, guideline developers, research sponsors, and the general public will all be beneficiaries.

Project description:BackgroundSystematic reviews (SRs) can help decision makers interpret the deluge of published biomedical literature. However, a SR may be of limited use if the methods used to conduct the SR are flawed, and reporting of the SR is incomplete. To our knowledge, since 2004 there has been no cross-sectional study of the prevalence, focus, and completeness of reporting of SRs across different specialties. Therefore, the aim of our study was to investigate the epidemiological and reporting characteristics of a more recent cross-section of SRs.Methods and findingsWe searched MEDLINE to identify potentially eligible SRs indexed during the month of February 2014. Citations were screened using prespecified eligibility criteria. Epidemiological and reporting characteristics of a random sample of 300 SRs were extracted by one reviewer, with a 10% sample extracted in duplicate. We compared characteristics of Cochrane versus non-Cochrane reviews, and the 2014 sample of SRs versus a 2004 sample of SRs. We identified 682 SRs, suggesting that more than 8,000 SRs are being indexed in MEDLINE annually, corresponding to a 3-fold increase over the last decade. The majority of SRs addressed a therapeutic question and were conducted by authors based in China, the UK, or the US; they included a median of 15 studies involving 2,072 participants. Meta-analysis was performed in 63% of SRs, mostly using standard pairwise methods. Study risk of bias/quality assessment was performed in 70% of SRs but was rarely incorporated into the analysis (16%). Few SRs (7%) searched sources of unpublished data, and the risk of publication bias was considered in less than half of SRs. Reporting quality was highly variable; at least a third of SRs did not report use of a SR protocol, eligibility criteria relating to publication status, years of coverage of the search, a full Boolean search logic for at least one database, methods for data extraction, methods for study risk of bias assessment, a primary outcome, an abstract conclusion that incorporated study limitations, or the funding source of the SR. Cochrane SRs, which accounted for 15% of the sample, had more complete reporting than all other types of SRs. Reporting has generally improved since 2004, but remains suboptimal for many characteristics.ConclusionsAn increasing number of SRs are being published, and many are poorly conducted and reported. Strategies are needed to help reduce this avoidable waste in research.

Project description:BackgroundSystematic reviews are increasingly used to inform health policy-making. The conflicts of interest (COI) of the authors of systematic reviews may bias their results and influence their conclusions. This may in turn lead to misguided public policies and systems level decisions. In order to mitigate the adverse impact of COI, scientific journals require authors to disclose their COIs. The objective of this study was to assess the frequency and different types of COI that authors of systematic reviews on health policy and systems research (HSPR) report.MethodsWe conducted a cross sectional survey. We searched the Health Systems Evidence (HSE) database of McMaster Health Forum for systematic reviews published in 2015. We extracted information regarding the characteristics of the systematic reviews and the associated COI disclosures. We conducted descriptive analyses.ResultsEighty percent of systematic reviews included authors' COI disclosures. Of the 160 systematic reviews that included COI disclosures, 15% had at least one author reporting at least one type of COI. The two most frequently reported types of COI were individual financial COI and individual scholarly COI (11% and 4% respectively). Institutional COIs were less commonly reported than individual COIs (3% and 15% respectively) and non-financial COIs were less commonly reported than financial COIs (6% and 14% respectively). Only one systematic review reported the COI disclosure by editors, and none reported disclosure by peer reviewers. All COI disclosures were in the form of a narrative statement in the main document and none in an online document.ConclusionA fifth of systematic reviews in HPSR do not include a COI disclosure statement, highlighting the need for journals to strengthen and/or better implement their COI disclosure policies. While only 15% of identified disclosure statements report any COI, it is not clear whether this indicates a low frequency of COI versus an underreporting of COI, or both.

Project description:ObjectiveTo estimate the degree of scatter of reports of randomised trials and systematic reviews, and how the scatter differs among medical specialties and subspecialties.DesignCross sectional analysis.Data sourcePubMed for all disease relevant randomised trials and systematic reviews published in 2009.Study selectionRandomised trials and systematic reviews of the nine diseases or disorders with the highest burden of disease, and the broader category of disease to which each belonged.ResultsThe scatter across journals varied considerably among specialties and subspecialties: otolaryngology had the least scatter (363 trials across 167 journals) and neurology the most (2770 trials across 896 journals). In only three subspecialties (lung cancer, chronic obstructive pulmonary disease, hearing loss) were 10 or fewer journals needed to locate 50% of trials. The scatter was less for systematic reviews: hearing loss had the least scatter (10 reviews across nine journals) and cancer the most (670 reviews across 279 journals). For some specialties and subspecialties the papers were concentrated in specialty journals; whereas for others, few of the top 10 journals were a specialty journal for that area. Generally, little overlap occurred between the top 10 journals publishing trials and those publishing systematic reviews. The number of journals required to find all trials or reviews was highly correlated (r = 0.97) with the number of papers for each specialty/subspecialty.ConclusionsPublication rates of speciality relevant trials vary widely, from one to seven trials per day, and are scattered across hundreds of general and specialty journals. Although systematic reviews reduce the extent of scatter, they are still widely scattered and mostly in different journals to those of randomised trials. Personal subscriptions to journals, which are insufficient for keeping up to date with knowledge, need to be supplemented by other methods such as journal scanning services or systems that cover sufficient journals and filter articles for quality and relevance. Few current systems seem adequate.

Project description:BackgroundAn increasing number of systematic reviews assessed the safety of surgical interventions over time. How well these systematic reviews were designed and conducted determines the reliability of evidence. In this study, we aimed to assess the methodological quality of systematic reviews on the safety of surgical interventions.MethodsWe searched PubMed for systematic reviews of surgical interventions with safety as the exclusive outcome from 1st-Jan, 2015 to 1st-Jan, 2020. The methodological quality of eligible systematic reviews was evaluated according to the AMSTAR 2.0 instrument. The primary outcomes were the number of methodological weaknesses and the global methodological quality. The proportion of each methodological weakness among eligible systematic reviews was compared by three pre-defined stratification variables. The absolute difference of the proportion (PD) was used as the effect estimator, with the two-tailed z-test for the significance.ResultsWe identified 127 systematic reviews from 18,636 records. None (n = 0, 0.00%) of them could be rated as "high" in terms of the global methodological quality; in contrast, they were either rated as "low" (n = 18, 14.17%) or as "critically low" (n = 109, 85.83%). The median number of methodological weaknesses of these systematic reviews was 8 (interquartile range, IQR: 6 to 9), in which 4 (IQR: 2 to 4) were critical weaknesses. Systematic reviews that used any reporting guideline (e.g., domain 13, PD = -0.22, 95% CI: - 0.39, - 0.06; p = 0.01) and developed a protocol in advance (e.g., domain 6, PD = -0.20, 95% CI: - 0.39, - 0.01; p = 0.04) were less likely to have methodological weakness in some domains but not for the rest (e.g., domain 8, PD = 0.04, 95% CI: - 0.14, 0.21; p = 0.68; with protocol vs. without).ConclusionsThe methodological quality of current systematic reviews of adverse events with surgical interventions was poor. Further efforts, for example, encouraging researchers to develop a protocol in advance, are needed to enhance the methodological quality of these systematic reviews.

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How do authors of systematic reviews deal with research malpractice and misconduct in original studies? A cross-sectional analysis of systematic reviews and survey of their authors.

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