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Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review.

ABSTRACT: Background:Many authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials. Methods:Using terms related to 'medical writer' and 'observational study', we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings of the International Society for Medical Publication Professionals (ISMPP; 2014-2018). We also hand-searched the journals Medical Writing and The Write Stuff (2014-2018) and the bibliographies of studies identified in the electronic searches. We screened the results to identify studies that compared the quality, ethics and timeliness of clinical trial publications written with and without declared PMWS. Results:Our searches identified 97 potentially relevant studies, of which 89 were excluded during screening and full paper review. The remaining eight studies compared 849 publications with PMWS with 2073 articles developed without such support. In these eight studies, PMWS was shown to be associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines (in 3/3 studies in which this was assessed), publication in journals with an impact factor (one study), a higher quality of written English (one study), and a lower likelihood of reporting non-pre-specified outcomes (one study). PMWS was not associated with increased adherence to CONSORT for Abstracts guidelines (one study) or with the impact of published articles (mean number of citations per year, mean number of article views per year and Altmetric score; one study). In studies that assessed timeliness of publication, PMWS was associated with a reduced time from last patient visit in clinical trials to primary publication (one study), whereas time from submission to acceptance showed inconsistent results (two studies). Conclusions:This systematic review of eight observational studies suggests that PMWS is positively associated with measures of overall quality of reporting of clinical trials and may improve the timeliness of publication.

SUBMITTER: Evuarherhe O

PROVIDER: S-EPMC6621980 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review.

Evuarherhe Obaro O Gattrell William W White Richard R Winchester Christopher C CC

Research integrity and peer review 20190710

<h4>Background</h4>Many authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials.<h4>Methods</h4>Using terms related to 'medical writer' and 'observational study', we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings ...[more]

PMID: 31338209

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Project description:AimsWe conducted a systematic review assessing the reporting quality of studies validating models based on machine learning (ML) for clinical diagnosis, with a specific focus on the reporting of information concerning the participants on which the diagnostic task was evaluated on.MethodMedline Core Clinical Journals were searched for studies published between July 2015 and July 2018. Two reviewers independently screened the retrieved articles, a third reviewer resolved any discrepancies. An extraction list was developed from the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis guideline. Two reviewers independently extracted the data from the eligible articles. Third and fourth reviewers checked, verified the extracted data as well as resolved any discrepancies between the reviewers.ResultsThe search results yielded 161 papers, of which 28 conformed to the eligibility criteria. Detail of data source was reported in 24 of the 28 papers. For all of the papers, the set of patients on which the ML-based diagnostic system was evaluated was partitioned from a larger dataset, and the method for deriving such set was always reported. Information on the diagnostic/non-diagnostic classification was reported well (23/28). The least reported items were the use of reporting guideline (0/28), distribution of disease severity (8/28 patient flow diagram (10/28) and distribution of alternative diagnosis (10/28). A large proportion of studies (23/28) had a delay between the conduct of the reference standard and ML tests, while one study did not and four studies were unclear. For 15 studies, it was unclear whether the evaluation group corresponded to the setting in which the ML test will be applied to.ConclusionAll studies in this review failed to use reporting guidelines, and a large proportion of them lacked adequate detail on participants, making it difficult to replicate, assess and interpret study findings.Prospero registration numberCRD42018099167.

Project description:BackgroundPrevious reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials.Objective/designWe conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials.Data sources(1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. ELIGIBILITY: (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes.Results(1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in "Instructions to Authors."ConclusionExisting reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely missing from trial publications; most leading journals in social and behavioural sciences do not ask authors to follow reporting standards. Findings demonstrate a need to develop a CONSORT extension with updated standards for social and psychological intervention trials.

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Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review.

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Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review.

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