Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study

Gattrell, William; Hopewell, Sally; Young, Kate; Farrow, Paul; White, Richard M.; Wager, Elizabeth; Winchester, Christopher C

doi:10.1136/bmjopen-2015-010329

Cited by 33 publications

(41 citation statements)

References 33 publications

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“…Our searches identified 75 potentially relevant publications after exclusion of 22 duplicate 98 publications; 70 were excluded during screening and full paper review, and three were identified in 99 bibliographies of identified studies (Figure 1). Of the eight included studies, three were full 100 publications (two in peer-reviewed journals [13,14], one in a non-peer reviewed journal [15]), and 101 five were congress abstracts (four poster presentations [16][17][18][19], one oral presentation [20]). Although 102 no date limit was included in the search strategy, only two of the identified studies were published 103 before 2015: one in 2006 [7] and the other in 2010 [15] ( Table 1).…”

Section: Search Results 97mentioning

confidence: 99%

“…Of the identified studies comparing articles developed with and without PMWS, three assessed 107 adherence to CONSORT guidelines [14,15,19]. Each of these studies, using a different statistical 108 approach to assess adherence, showed that PMWS was associated with increased adherence to 109 CONSORT guidelines ( Table 2).…”

Section: Quality Of Reporting 106mentioning

confidence: 99%

“…Each of these studies, using a different statistical 108 approach to assess adherence, showed that PMWS was associated with increased adherence to 109 CONSORT guidelines ( Table 2). Articles developed with PMWS were significantly more likely to 110 report completely at least 50% of the assessed CONSORT items (p < 0.05) [14,21] and to comply 111 with more CONSORT items than articles without PMWS (p < 0.05) [15]. Similarly, articles with 80-112 100% compliance with CONSORT items were significantly more likely to have been developed with 113 PMWS than those with less than 80% compliance (p < 0.0001) [19].…”

Section: Quality Of Reporting 106mentioning

confidence: 99%

“…Similarly, articles with 80-112 100% compliance with CONSORT items were significantly more likely to have been developed with 113 PMWS than those with less than 80% compliance (p < 0.0001) [19]. Looking at individual 114 CONSORT items, one identified study showed that articles with PMWS were significantly more 115 likely to report all important adverse events or side effects than those without PMWS [15], and 116 another showed that PMWS increased adherence to six of 12 CONSORT items assessed: specification 117 of primary outcome; sample size calculation; type of randomization; publication of a participant flow 118 diagram; provision of dates defining recruitment and follow-up; and details of trial registration [14]. 119…”

Section: Quality Of Reporting 106mentioning

confidence: 99%

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

Evuarherhe¹,

Gattrell

White

et al. 2018

Preprint

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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; 2014-2017). We also hand-searched the journals Medical Writing and The Write Stuff (2014-2017), 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 increases the overall quality of reporting of clinical trials and may improve the timeliness of publication.

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Section: Search Results 97mentioning

confidence: 99%

Section: Quality Of Reporting 106mentioning

confidence: 99%

Section: Quality Of Reporting 106mentioning

confidence: 99%

Section: Quality Of Reporting 106mentioning

confidence: 99%

See 2 more Smart Citations

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

Evuarherhe¹,

Gattrell

White

et al. 2018

Preprint

Self Cite

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show abstract

“…3,4 -A full-text search identified those with acknowledged medical writer support (MW). -The control group without acknowledged medical writer support (non-MW) comprised the remainder of articles, reduced in an unbiased manner to a manageable size by selecting those beginning with page numbers 1-7 inclusive.…”

Section: Methodsmentioning

confidence: 99%

Professional medical writing support and the quality of randomized controlled trial reporting: a cross-sectional study

Gattrell¹,

Hopewell²,

Farrow³

et al. 2016

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Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals

et al. 2023

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ImportanceThe practice of using medical writers to communicate scientific information has gained popularity, but it may affect how and what information is communicated.ObjectiveTo assess characteristics of oncology trials that use medical writers and whether there is an association between the use of medical writers and trial success or the primary outcome evaluated.Design, Setting, and ParticipantsThis cross-sectional study included oncology trials testing a tumor-targeting intervention that were published in The Lancet, The Lancet Oncology, JAMA, JAMA Oncology, Journal of Clinical Oncology, and The New England Journal of Medicine between May 1, 2021, and May 1, 2022.ExposuresAssistance of medical writers or no assistance.Main Outcomes and MeasuresThe main outcomes were the percentage of studies with medical writers, the percentage of trial successes reported with medical writers, the association between trial success and medical writer use, and the association between a primary end point and medical writer use.ResultsAmong 270 studies, 141 (52.2%) included a medical writer and 129 (47.8%) did not include a medical writer. Of the studies that included a medical writer, 83 (58.9%) were successful. Of the studies that did not include a medical writer, 64 (49.6%) were successful (P = .16 for difference). Studies with medical writers were less likely than studies without medical writers to have the end point of overall survival (15 [10.6%] vs 17 [13.2%]) and disease-free or event-free survival (16 [11.3%] vs 29 [22.5%]), whereas studies with a medical writer were more likely to have the end point of progression-free survival (32 [22.7%] vs 17 [13.2%]). Use of medical writer was associated with the conclusions being presented favorably in all studies (113 [80.1%] vs 89 [69.0%]; odds ratio [OR], 1.81 [95% CI, 1.04-3.19]), but when adjusted for other variables, there was no association (OR, 1.84 [95% CI, 0.92-3.72]).Conclusions and RelevanceIn this cross-sectional study, trials using medical writers were more likely to report surrogate end points, such as progression-free survival, and favorable conclusions, but when adjusted for trial phase, randomization, and study funding, there was no association with favorable conclusions. These findings suggest that journals need heightened scrutiny for studies with medical writers and that authorship should be properly acknowledged.

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Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study

Cited by 33 publications

References 33 publications

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

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

Professional medical writing support and the quality of randomized controlled trial reporting: a cross-sectional study

Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals

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