Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals

Ira Mills; Catherine Sheard; Meredith Hays; Kevin Douglas; Christopher C. Winchester; William T. Gattrell

doi:10.12688/f1000research.12268.1

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Research Note

Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals

[version 1; peer review: 1 approved, 1 approved with reservations]

Ira Mills ¹, Catherine Sheard², Meredith Hays³, Kevin Douglas³, Christopher C. Winchester^4,5, William T. Gattrell^6,7

Ira Mills ¹, Catherine Sheard², [...] Meredith Hays³, Kevin Douglas³, Christopher C. Winchester^4,5, William T. Gattrell^6,7

PUBLISHED 16 Aug 2017

Author details Author details

¹ PAREXEL International, Hackensack, NJ, 07601, USA
² Department of Archaeology and Anthropology, University of Bristol, Bristol, BS8 1TH, UK
³ Department of Medicine, Uniformed Services University, Bethesda, MD, 20814, USA
⁴ School of Medicine, Pharmacy and Health, Durham University, Stockton on Tees, TS17 6BH, UK
⁵ Research Evaluation Unit, Oxford PharmaGenesis Ltd, Oxford, OX13 5QJ, UK
⁶ Oxford Brookes University, Oxford, OX3 0BP, UK
⁷ Ipsen Pharma, Abingdon, OX14 4RL, UK

Ira Mills
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Catherine Sheard
Roles: Data Curation, Formal Analysis, Investigation, Methodology, Software, Visualization, Writing – Review & Editing

Meredith Hays
Roles: Data Curation, Investigation, Writing – Review & Editing

Kevin Douglas
Roles: Data Curation, Investigation, Methodology, Visualization, Writing – Review & Editing

Christopher C. Winchester
Roles: Conceptualization, Investigation, Methodology, Visualization, Writing – Review & Editing

William T. Gattrell
Roles: Conceptualization, Investigation, Methodology, Visualization, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background: In articles reporting randomized controlled trials, professional medical writing support is associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT). We set out to determine whether professional medical writing support was also associated with improved adherence to CONSORT for Abstracts.
Methods: Using data from a previously published cross-sectional study of 463 articles reporting randomized controlled trials published between 2011 and 2014 in five top medical journals, we determined the association between professional medical writing support and CONSORT for Abstracts items using a Wilcoxon rank-sum test.
Results: The mean proportion of adherence to CONSORT for Abstracts items reported was similar with and without professional medical writing support (64.3% vs 66.5%, respectively; p=0.30). Professional medical writing support was associated with lower adherence to reporting study setting (relative risk [RR]; 0.40; 95% confidence interval [CI], 0.23–0.70), and higher adherence to disclosing harms/side effects (RR 2.04; 95% CI, 1.37–3.03) and funding source (RR 1.75; 95% CI, 1.18–2.60).
Conclusions: Although professional medical writing support was not associated with increased overall adherence to CONSORT for Abstracts, important aspects were improved with professional medical writing support, including reporting of adverse events and funding source. This study identifies areas to consider for improvement.

Keywords

randomized controlled trials, medical writing, CONSORT guidelines, abstracts, adherence, adverse events, funding source

Corresponding author: Ira Mills

Competing interests: Mills I is an employee of PAREXEL International. Sheard C, Hays M, and Douglas K have no disclosures to report. Gattrell WT is an employee of Ipsen Biopharma. Winchester CC is an employee and Director of Oxford PharmaGenesis Ltd, and a Director and shareholder of Oxford PharmaGenesis Holdings Ltd.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2017 Mills I et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Data associated with the article are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).

How to cite: Mills I, Sheard C, Hays M et al. Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2017, 6:1489 (https://doi.org/10.12688/f1000research.12268.1) First published: 16 Aug 2017, 6:1489 (https://doi.org/10.12688/f1000research.12268.1) Latest published: 14 Sep 2017, 6:1489 (https://doi.org/10.12688/f1000research.12268.2)

Introduction

Prior studies demonstrate low levels of adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines^1,2, as well as CONSORT for Abstracts^3,4 in reporting randomized controlled trials (RCTs). Professional medical writing support, correctly acknowledged, is endorsed by Good Publication Practice (GPP3)⁵, and its prevalence increased between 2001/2002 and 2009/2010, with a reported doubling to nearly 35% of industry-sponsored studies⁶. Professional medical writing support is associated with increased adherence to CONSORT in articles reporting RCTs; in a sample of open-access journals, the number of articles that completely reported ≥50% of the studied CONSORT items was significantly higher with professional medical writing support (39%) than without professional medical writing support (21%; p<0.05)^7,8.

The purpose of this study was to determine whether professional medical writing support was also associated with improved adherence to CONSORT for Abstracts by analyzing a published dataset from five high-impact general medical journals with overall variable and incomplete adherence⁹.

Methods

We examined data from a published cross-sectional study of 463 articles reporting RCTs⁹. The RCTs were published between 2011 and 2014 in five top medical journals: The New England Journal of Medicine, Annals of Internal Medicine, The Lancet, The BMJ, and JAMA. We determined the association between professional medical writing support and the reporting of CONSORT for Abstracts items¹⁰ (Table 1) using a Wilcoxon rank-sum test. One author (CS), who was blinded to the CONSORT for Abstracts scores using de-identified original dataset outputs, identified articles as being prepared with professional medical writing support using automated searching followed by manual review if they acknowledged the involvement of one of the following: medical writer, medical writing, writing services, writing assistance, editorial assistance, or editorial support. The context of these terms was also examined.

Table 1. CONSORT for Abstracts checklist items¹⁰, with descriptors by Hays et al.⁹ as used for this subanalysis.

CONSORT for Abstracts items
Abstract evaluation checklist	Yes	No
Title
1. Do the authors state explicitly in the title that the participants were randomly assigned to their comparison groups?
Trial design
2. Is the type of randomized controlled trial described (e.g. parallel group, cluster randomized, crossover, factorial, superiority, noninferiority, or some other combination of these)?
Methods
Participants
3. Is there a clear description of the eligibility criteria for trial participants (e.g. inclusion and/or exclusion criteria)? Can the reader reasonably describe the study population and assess the generalizability of the trial?
4. Is there a clear description of the setting of the participants studied (i.e. primary/secondary/tertiary care center, government health clinic, community clinic; level of care provided at study site)? This does not have to mention geographic setting (i.e. country).
Intervention
5. Are essential features of the experimental and comparison interventions described, including details about the interventions (e.g. dose, route of administration, duration of administration, surgical procedure, or manufacturer of inserted device)? The abstract must give details about the intervention to help the reader quickly assess the validity of the study.
Objective
6. Is there a clear statement of the specific objective or hypothesis addressed in the trial? Either a clear statement is made or it is not.
Outcome
7. Do the authors explicitly state the primary or main outcome for the trial and when it was assessed (e.g. the time frame over which it was measured)?
Randomization
8. Do the authors clearly describe the method for random sequence generation in assigning participants to interventions?
9. Do the authors clearly describe the method of allocation concealment?
Blinding
10. Is the study “blinded” or “masked” to group assignment?
11. Does the abstract specify who was “blinded” or “masked” (e.g. participants, caregivers, those assessing outcomes, data analysts)?
Results
12. Is the number of participants randomized to each group stated?
13. Is the number of participants analyzed for each group stated?
14. Is the primary outcome result for each group stated?
15. Is there an estimated effect size and precision (i.e. are confidence intervals given)?
16. Is there an explicit statement of harms or side effects, or an explicit statement of their absence? Harms and side effects do not have to be specifically labeled as such. Abstracts can satisfy this criterion by stating specific outcomes that are not the primary objective of the study and could reasonably be considered a harm or side effect of the intervention or treatment. This is typically stated in the last sentence of the results.
Conclusions
17. Is the interpretation of the trial clearly stated?
Registration
18. Is the trial registration number and trial register stated?
Funding
19. Is the source of funding for the trial stated?

Mean proportions of CONSORT for Abstract adherence with and without professional medical writing support was compared using a Wilcoxon rank-sum test, and then tested with additional effect of variable journal adherence using an analysis of variance (ANOVA). The relative risk (RR) and 95% confidence interval (CI) for each item’s adherence with and without professional medical writing support were calculated using the command “oddsratio” in the R package fmsb 0.5.2¹¹. All statistical analyses were performed in R 3.2.2¹².

Results

From the original published dataset of 463 abstracts from RCTs reported in five journals, acknowledged professional medical writing support was observed in 66 articles (14.3%). Two articles identified in the automated search were excluded on manual review, one of which stated¹³, “there was no writing assistance from anyone who is not listed as an author,” and the other¹⁴, “the Writing committee drafted the report… without editorial assistance.” The mean proportion of CONSORT for Abstracts items reported in articles with (n=66) and without (n=397) professional medical writing support was 64.3% versus 66.5%, respectively; p=0.3044 (Wilcoxon rank-sum test). This difference remained nonsignificant when journal variation in CONSORT for Abstracts adherence was considered (ANOVA, p=0.1347). Overall, reporting of the individual CONSORT for Abstracts items was similar with and without professional medical writing support (RR 0.97; 95% CI, 0.88–1.07) (Figure 1). However, a lower rate of reporting the study setting (item 4) was observed in articles with professional medical writing support (RR 0.40; 95% CI, 0.23–0.70). Conversely, professional medical writing support was associated with higher adherence to reporting both harms and side effects (item 16) (RR 2.04; 95% CI, 1.37–3.03) and source of funding (item 19) (RR 1.75; 95% CI, 1.18–2.60).

Figure 1. Reporting of CONSORT for Abstracts items in articles with and without acknowledged professional medical writing support.

CONSORT, Consolidated Standards of Reporting Trials; PMWS, professional medical writing support. Significant associations are shaded.

study_id	journal_id	title	abstract_nh	title1	type2	eligbility3	setting4	intervention5	objective6	primary7	sequence8	blinded10	who11	blind-both	nrandomized12	nanalyzed13	outcomestated14	effectsize15	harms16	interpretation17	registration18	funding19	total	out of	adhere	outcome20
1	3	Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial.	The clinical benefit of preventive eradication of unruptured brain arteriovenous malformations remains uncertain. A Randomised trial of Unruptured Brain Arteriovenous malformations (ARUBA) aims to compare the risk of death and symptomatic stroke in patients with an unruptured brain arteriovenous malformation who are allocated to either medical management alone or medical management with interventional therapy. Adult patients (>18 years) with an unruptured brain arteriovenous malformation were enrolled into this trial at 39 clinical sites in nine countries. Patients were randomised (by web-based system, in a 1:1 ratio, with random permuted block design [block size 2, 4, or 6], stratified by clinical site) to medical management with interventional therapy (ie, neurosurgery, embolisation, or stereotactic radiotherapy, alone or in combination) or medical management alone (ie, pharmacological therapy for neurological symptoms as needed). Patients, clinicians, and investigators are aware of treatment assignment. The primary outcome is time to the composite endpoint of death or symptomatic stroke; the primary analysis is by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00389181. Randomisation was started on April 4, 2007, and was stopped on April 15, 2013, when a data and safety monitoring board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health recommended halting randomisation because of superiority of the medical management group (log-rank Z statistic of 410, exceeding the prespecified stopping boundary value of 287). At this point, outcome data were available for 223 patients (mean follow-up 333 months [SD 197]), 114 assigned to interventional therapy and 109 to medical management. The primary endpoint had been reached by 11 (101%) patients in the medical management group compared with 35 (307%) in the interventional therapy group. The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group (hazard ratio 027, 95% CI 014-054). No harms were identified, other than a higher number of strokes (45 vs 12, p<00001) and neurological deficits unrelated to stroke (14 vs 1, p=00008) in patients allocated to interventional therapy compared with medical management. The ARUBA trial showed that medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations followed up for 33 months. The trial is continuing its observational phase to establish whether the disparities will persist over an additional 5 years of follow-up. National Institutes of Health, National Institute of Neurological Disorders and Stroke. Copyright 2014 Elsevier Ltd. All rights reserved.	1	0	1	0	0	1	1	1	1	1	1	0	1	1	1	1	1	1	1	13	18	1	1
2	1	Enzalutamide in metastatic prostate cancer before chemotherapy.	Enzalutamide is an oral androgen-receptor inhibitor that prolongs survival in men with metastatic castration-resistant prostate cancer in whom the disease has progressed after chemotherapy. New treatment options are needed for patients with metastatic prostate cancer who have not received chemotherapy, in whom the disease has progressed despite androgen-deprivation therapy. In this double-blind, phase 3 study, we randomly assigned 1717 patients to receive either enzalutamide (at a dose of 160 mg) or placebo once daily. The coprimary end points were radiographic progression-free survival and overall survival. The study was stopped after a planned interim analysis, conducted when 540 deaths had been reported, showed a benefit of the active treatment. The rate of radiographic progression-free survival at 12 months was 65% among patients treated with enzalutamide, as compared with 14% among patients receiving placebo (81% risk reduction; hazard ratio in the enzalutamide group, 0.19; 95% confidence interval [CI], 0.15 to 0.23; P<0.001). A total of 626 patients (72%) in the enzalutamide group, as compared with 532 patients (63%) in the placebo group, were alive at the data-cutoff date (29% reduction in the risk of death; hazard ratio, 0.71; 95% CI, 0.60 to 0.84; P<0.001). The benefit of enzalutamide was shown with respect to all secondary end points, including the time until the initiation of cytotoxic chemotherapy (hazard ratio, 0.35), the time until the first skeletal-related event (hazard ratio, 0.72), a complete or partial soft-tissue response (59% vs. 5%), the time until prostate-specific antigen (PSA) progression (hazard ratio, 0.17), and a rate of decline of at least 50% in PSA (78% vs. 3%) (P<0.001 for all comparisons). Fatigue and hypertension were the most common clinically relevant adverse events associated with enzalutamide treatment. Enzalutamide significantly decreased the risk of radiographic progression and death and delayed the initiation of chemotherapy in men with metastatic prostate cancer. (Funded by Medivation and Astellas Pharma; PREVAIL ClinicalTrials.gov number, NCT01212991.).	0	0	0	0	1	0	1	0	1	0	0	1	0	1	1	1	1	1	1	9	18	0	1
3	5	The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial.	Chronic periodontitis, a destructive inflammatory disorder of the supporting structures of the teeth, is prevalent in patients with diabetes. Limited evidence suggests that periodontal therapy may improve glycemic control. To determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin (HbA1c) in persons with type 2 diabetes and moderate to advanced chronic periodontitis. The Diabetes and Periodontal Therapy Trial (DPTT), a 6-month, single-masked, multicenter, randomized clinical trial. Participants had type 2 diabetes, were taking stable doses of medications, had HbA1c levels between 7% and less than 9%, and untreated chronic periodontitis. Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers. The treatment group (n=257) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months. The control group (n=257) received no treatment for 6 months. Difference in change in HbA1c level from baseline between groups at 6 months. Secondary outcomes included changes in probing pocket depths, clinical attachment loss, bleeding on probing, gingival index, fasting glucose level, and Homeostasis Model Assessment (HOMA2) score. Enrollment was stopped early because of futility. At 6 months, mean HbA1c levels in the periodontal therapy group increased 0.17% (SD, 1.0), compared with 0.11% (SD, 1.0) in the control group, with no significant difference between groups based on a linear regression model adjusting for clinical site (mean difference, -0.05% [95% CI, -0.23% to 0.12%]; P=.55). Periodontal measures improved in the treatment group compared with the control group at 6 months, with adjusted between-group differences of 0.28 mm (95% CI, 0.18 to 0.37) for probing depth, 0.25 mm (95% CI, 0.14 to 0.36) for clinical attachment loss, 13.1% (95% CI, 8.1% to 18.1%) for bleeding on probing, and 0.27 (95% CI, 0.17 to 0.37) for gingival index (P<.001 for all). Nonsurgical periodontal therapy did not improve glycemic control in patients with type 2 diabetes and moderate to advanced chronic periodontitis. These findings do not support the use of nonsurgical periodontal treatment in patients with diabetes for the purpose of lowering levels of HbA1c. clinicaltrials.gov Identifier: NCT00997178.	1	0	1	1	1	1	1	0	1	0	0	1	0	1	1	0	1	1	0	11	18	1	0
4	2	Effect of supplementation with high-selenium yeast on plasma lipids: a randomized trial.	High selenium status has been linked to elevated blood cholesterol levels in cross-sectional studies. To investigate the effect of selenium supplementation on plasma lipids. Randomized, placebo-controlled, parallel-group study stratified by age and sex. Participants, research nurses, and persons assessing outcomes were blinded to treatment assignment. (International Standard Randomised Controlled Trial Number Register registration number: ISRCTN25193534) 4 general practices in the United Kingdom. 501 volunteers aged 60 to 74 years. Participants received selenium, 100 mcg/d (n = 127), 200 mcg/d (n = 127), or 300 mcg/d (n = 126), as high-selenium yeast or a yeast-based placebo (n = 121) for 6 months. Total and high-density lipoprotein (HDL) cholesterol concentrations were measured in nonfasting plasma samples stored from participants in the UK PRECISE (United Kingdom PREvention of Cancer by Intervention with SElenium) Pilot Study at baseline (n = 454) and at 6 months (n = 394). Non-HDL cholesterol levels were calculated. Mean plasma selenium concentration was 88.8 ng/g (SD, 19.2) at baseline and increased statistically significantly in the treatment groups. The adjusted difference in change in total cholesterol levels for selenium compared with placebo was -0.22 mmol/L (-8.5 mg/dL) (95% CI, -0.42 to -0.03 mmol/L [-16.2 to -1.2 mg/dL]; P = 0.02) for 100 mcg of selenium per day, -0.25 mmol/L (-9.7 mg/dL) (CI, -0.44 to -0.07 mmol/L [-17.0 to -2.7 mg/dL]; P = 0.008) for 200 mcg of selenium per day, and -0.07 mmol/L (-2.7 mg/dL) (CI, -0.26 to 0.12 mmol/L [-10.1 to 4.6 mg/dL]; P = 0.46) for 300 mcg of selenium per day. Similar reductions were observed for non-HDL cholesterol levels. There was no apparent difference in change in HDL cholesterol levels with 100 and 200 mcg of selenium per day, but the difference was an adjusted 0.06 mmol/L (2.3 mg/dL) (CI, 0.00 to 0.11 mmol/L [0.0 to 4.3 mg/dL]; P = 0.045) with 300 mcg of selenium per day. The total-HDL cholesterol ratio decreased progressively with increasing selenium dose (overall P = 0.01). The duration of supplementation was limited, as was the age range of the participants. Selenium supplementation seemed to have modestly beneficial effects on plasma lipid levels in this sample of persons with relatively low selenium status. The clinical significance of the findings is unclear and should not be used to justify the use of selenium supplementation as additional or alternative therapy for dyslipidemia. This is particularly true for persons with higher selenium status, given the limitations of the trial and the potential additional risk in other metabolic dimensions. The Cancer Research Campaign (now Cancer Research UK) and the University of Surrey.	1	1	0	1	1	1	1	0	1	1	1	1	0	0	1	0	1	0	1	11	18	1	1
5	4	Effect of intervention aimed at increasing physical activity, reducing sedentary behaviour, and increasing fruit and vegetable consumption in children: active for Life Year 5 (AFLY5) school based cluster randomised controlled trial.	To investigate the effectiveness of a school based intervention to increase physical activity, reduce sedentary behaviour, and increase fruit and vegetable consumption in children. Cluster randomised controlled trial. 60 primary schools in the south west of England. Primary school children who were in school year 4 (age 8-9 years) at recruitment and baseline assessment, in year 5 during the intervention, and at the end of year 5 (age 9-10) at follow-up assessment. The Active for Life Year 5 (AFLY5) intervention consisted of teacher training, provision of lesson and child-parent interactive homework plans, all materials required for lessons and homework, and written materials for school newsletters and parents. The intervention was delivered when children were in school year 5 (age 9-10 years). Schools allocated to control received standard teaching. The pre-specified primary outcomes were accelerometer assessed minutes of moderate to vigorous physical activity per day, accelerometer assessed minutes of sedentary behaviour per day, and reported daily consumption of servings of fruit and vegetables. 60 schools with more than 2221 children were recruited; valid data were available for fruit and vegetable consumption for 2121 children, for accelerometer assessed physical activity and sedentary behaviour for 1252 children, and for secondary outcomes for between 1825 and 2212 children for the main analyses. None of the three primary outcomes differed between children in schools allocated to the AFLY5 intervention and those allocated to the control group. The difference in means comparing the intervention group with the control group was -1.35 (95% confidence interval -5.29 to 2.59) minutes per day for moderate to vigorous physical activity, -0.11 (-9.71 to 9.49) minutes per day for sedentary behaviour, and 0.08 (-0.12 to 0.28) servings per day for fruit and vegetable consumption. The intervention was effective for three out of nine of the secondary outcomes after multiple testing was taken into account: self reported time spent in screen viewing at the weekend (-21 (-37 to -4) minutes per day), self reported servings of snacks per day (-0.22 (-0.38 to -0.05)), and servings of high energy drinks per day (-0.26 (-0.43 to -0.10)) were all reduced. Results from a series of sensitivity analyses testing different assumptions about missing data and from per protocol analyses produced similar results. The findings suggest that the AFLY5 school based intervention is not effective at increasing levels of physical activity, decreasing sedentary behaviour, and increasing fruit and vegetable consumption in primary school children. Change in these activities may require more intensive behavioural interventions with children or upstream interventions at the family and societal level, as well as at the school environment level. These findings have relevance for researchers, policy makers, public health practitioners, and doctors who are involved in health promotion, policy making, and commissioning services. Trial registration Current Controlled Trials ISRCTN50133740. Kipping et al 2014.	1	1	1	1	0	1	1	0	0	0	NA	1	1	0	1	0	1	1	0	11	17	1	0
6	1	Randomized trial of posaconazole and benznidazole for chronic Chagas' disease.	Current therapeutic options for Chagas' disease are limited to benznidazole and nifurtimox, which have been associated with low cure rates in the chronic stage of the disease and which have considerable toxicity. Posaconazole has shown trypanocidal activity in murine models. We performed a prospective, randomized clinical trial to assess the efficacy and safety of posaconazole as compared with the efficacy and safety of benznidazole in adults with chronic Trypanosoma cruzi infection. We randomly assigned patients to receive posaconazole at a dose of 400 mg twice daily (high-dose posaconazole), posaconazole at a dose of 100 mg twice daily (low-dose posaconazole), or benznidazole at a dose of 150 mg twice daily; all the study drugs were administered for 60 days. We assessed antiparasitic activity by testing for the presence of T. cruzi DNA, using real-time polymerase-chain-reaction (rt-PCR) assays, during the treatment period and 10 months after the end of treatment. Posaconazole absorption was assessed on day 14. The intention-to-treat population included 78 patients. During the treatment period, all the patients tested negative for T. cruzi DNA on rt-PCR assay beyond day 14, except for 2 patients in the low-dose posaconazole group who tested positive on day 60. During the follow-up period, in the intention-to-treat analysis, 92% of the patients receiving low-dose posaconazole and 81% receiving high-dose posaconazole, as compared with 38% receiving benznidazole, tested positive for T. cruzi DNA on rt-PCR assay (P<0.01 for the comparison of the benznidazole group with either posaconazole group); in the per-protocol analysis, 90% of the patients receiving low-dose posaconazole and 80% of those receiving high-dose posaconazole, as compared with 6% receiving benznidazole, tested positive on rt-PCR assay (P<0.001 for the comparison of the benznidazole group with either posaconazole group). In the benznidazole group, treatment was discontinued in 5 patients because of severe cutaneous reactions; in the posaconazole groups, 4 patients had aminotransferase levels that were more than 3 times the upper limit of the normal range, but there were no discontinuations of treatment. Posaconazole showed antitrypanosomal activity in patients with chronic Chagas' disease. However, significantly more patients in the posaconazole groups than in the benznidazole group had treatment failure during follow-up. (Funded by the Ministry of Health, Spain; CHAGASAZOL ClinicalTrials.gov number, NCT01162967.).	1	0	0	0	1	1	0	0	0	0	NA	0	0	0	0	1	1	1	1	7	17	0	0
7	4	Long term effect of depression care management on mortality in older adults: follow-up of cluster randomized clinical trial in primary care.	To investigate whether an intervention to improve treatment of depression in older adults in primary care modified the increased risk of death associated with depression. Long term follow-up of multi-site practice randomized controlled trial (PROSPECT-Prevention of Suicide in Primary Care Elderly: Collaborative Trial). 20 primary care practices in New York City, Philadelphia, and Pittsburgh, USA, randomized to intervention or usual care. 1226 participants identified between May 1999 and August 2001 through a two stage, age stratified (60-74; > 75 years) depression screening of randomly sampled patients; enrollment included patients who screened positive and a random sample of patients who screened negative. For two years, a depression care manager worked with primary care physicians in intervention practices to provide algorithm based care for depression, offering psychotherapy, increasing antidepressant dose if indicated, and monitoring symptoms, adverse effects of drugs, and adherence to treatment. This paper reports the long term follow-up. Mortality risk based on a median follow-up of 98 (range 0.8-116.4) months through 2008. In baseline clinical interviews, 396 people were classified as having major depression, 203 had clinically significant minor depression, and 627 did not meet criteria for depression. At follow-up, 405 patients had died. Patients with major depression in usual care were more likely to die than were those without depression (hazard ratio 1.90, 95% confidence interval 1.57 to 2.31). In contrast, patients with major depression in intervention practices were at no greater risk than were people without depression (hazard ratio 1.09, 0.83 to 1.44). Patients with major depression in intervention practices, relative to usual care, were 24% less likely to have died (hazard ratio 0.76, 0.57 to 1.00; P=0.05). Preliminary data on cause of death are provided. No significant effect on mortality was found for minor depression. Older adults with major depression in practices provided with additional resources to intensively manage depression had a mortality risk lower than that observed in usual care and similar to older adults without depression. Clinical trials NCT00000367.	1	1	1	1	1	1	1	0	0	0	NA	0	0	0	1	0	1	1	0	10	17	1	1
8	4	Effectiveness of dementia follow-up care by memory clinics or general practitioners: randomised controlled trial.	To examine the effectiveness of post-diagnosis dementia treatment and coordination of care by memory clinics compared with general practitioners. Multicentre randomised controlled trial. Nine memory clinics and 159 general practitioners in the Netherlands. 175 patients with a new diagnosis of mild to moderate dementia living in the community and their informal caregivers. Usual care provided by memory clinic or general practitioner. Caregiver rated quality of life of the patient measured with the quality of life in Alzheimer's disease instrument and self perceived burden of the informal caregiver measured with the sense of competence questionnaire (intention to treat analysis). The quality of life of the patients in the memory clinic group was 0.5 (95% confidence interval -0.7 to 1.6) points higher than in the general practitioner group. Caregivers' burden was 2.4 (-5.8 to 1.0) points lower in the memory clinic group than in the general practitioner group. No evidence was found that memory clinics were more effective than general practitioners with regard to post-diagnosis treatment and coordination care for patients with dementia. Without further evidence on the effectiveness of these modalities, other arguments, such as cost minimisation, patients' preferences, or regional health service planning, can determine which type of dementia care is offered. Clinical trials NCT00554047.	1	0	1	1	0	1	1	0	0	0	NA	0	0	0	1	0	0	1	0	7	17	0	0
9	1	Introduction of gluten, HLA status, and the risk of celiac disease in children.	The relationship between the risk of celiac disease and both the age at which gluten is introduced to a child's diet and a child's early dietary pattern is unclear. We randomly assigned 832 newborns who had a first-degree relative with celiac disease to the introduction of dietary gluten at 6 months (group A) or 12 months (group B). The HLA genotype was determined at 15 months of age, and serologic screening for celiac disease was evaluated at 15, 24, and 36 months and at 5, 8, and 10 years. Patients with positive serologic findings underwent intestinal biopsies. The primary outcome was the prevalence of celiac disease autoimmunity and of overt celiac disease among the children at 5 years of age. Of the 707 participants who remained in the trial at 36 months, 553 had a standard-risk or high-risk HLA genotype and completed the study. At 2 years of age, significantly higher proportions of children in group A than in group B had celiac disease autoimmunity (16% vs. 7%, P=0.002) and overt celiac disease (12% vs. 5%, P=0.01). At 5 years of age, the between-group differences were no longer significant for autoimmunity (21% in group A and 20% in group B, P=0.59) or overt disease (16% and 16%, P=0.78 by the log-rank test). At 10 years, the risk of celiac disease autoimmunity was far higher among children with high-risk HLA than among those with standard-risk HLA (38% vs. 19%, P=0.001), as was the risk of overt celiac disease (26% vs. 16%, P=0.05). Other variables, including breast-feeding, were not associated with the development of celiac disease. Neither the delayed introduction of gluten nor breast-feeding modified the risk of celiac disease among at-risk infants, although the later introduction of gluten was associated with a delayed onset of disease. A high-risk HLA genotype was an important predictor of disease. (Funded by the Fondazione Celiachia of the Italian Society for Celiac Disease; CELIPREV ClinicalTrials.gov number, NCT00639444.).	0	0	1	0	1	0	1	0	0	0	NA	0	0	1	0	0	1	1	1	7	17	0	0
10	5	Effect of weight reduction and cardiometabolic risk factor management on symptom burden and severity in patients with atrial fibrillation: a randomized clinical trial.	Obesity is a risk factor for atrial fibrillation. Whether weight reduction and cardiometabolic risk factor management can reduce the burden of atrial fibrillation is not known. To determine the effect of weight reduction and management of cardiometabolic risk factors on atrial fibrillation burden and cardiac structure. Single-center, partially blinded, randomized controlled study conducted between June 2010 and December 2011 in Adelaide, Australia, among overweight and obese ambulatory patients (N=150) with symptomatic atrial fibrillation. Patients underwent a median of 15 months of follow-up. Patients were randomized to weight management (intervention) or general lifestyle advice (control). Both groups underwent intensive management of cardiometabolic risk factors. The primary outcomes were Atrial Fibrillation Severity Scale scores: symptom burden and symptom severity. Scores were measured every 3 months from baseline to 15 months. Secondary outcomes performed at baseline and 12 months were total atrial fibrillation episodes and cumulative duration measured by 7-day Holter, echocardiographic left atrial area, and interventricular septal thickness. Of 248 patients screened, 150 were randomized (75 per group) and underwent follow-up. The intervention group showed a significantly greater reduction, compared with the control group, in weight (14.3 and 3.6 kg, respectively; P<.001) and in atrial fibrillation symptom burden scores (11.8 and 2.6 points, P<.001), symptom severity scores (8.4 and 1.7 points, P<.001), number of episodes (2.5 and no change, P=.01), and cumulative duration (692-minute decline and 419-minute increase, P=.002). Additionally, there was a reduction in interventricular septal thickness in the intervention and control groups (1.1 and 0.6 mm, P=.02) and left atrial area (3.5 and 1.9 cm2, P=.02). In this study, weight reduction with intensive risk factor management resulted in a reduction in atrial fibrillation symptom burden and severity and in beneficial cardiac remodeling. These findings support therapy directed at weight and risk factors in the management of atrial fibrillation. anzctr.org.au Identifier: ACTRN12610000497000.	1	0	1	0	0	1	1	0	0	0	NA	1	0	1	0	0	1	1	0	8	17	0	1
11	2	Effect of adding systematic family history enquiry to cardiovascular disease risk assessment in primary care: a matched-pair, cluster randomized trial.	Evidence of the value of systematically collecting family history in primary care is limited. To evaluate the feasibility of systematically collecting family history of coronary heart disease in primary care and the effect of incorporating these data into cardiovascular risk assessment. Pragmatic, matched-pair, cluster randomized, controlled trial. (International Standardized Randomized Controlled Trial Number Register: ISRCTN 17943542). 24 family practices in the United Kingdom. 748 persons aged 30 to 65 years with no previously diagnosed cardiovascular risk, seen between July 2007 and March 2009. Participants in control practices had the usual Framingham-based cardiovascular risk assessment with and without use of existing family history information in their medical records. Participants in intervention practices also completed a questionnaire to systematically collect their family history. All participants were informed of their risk status. Participants with high cardiovascular risk were invited for a consultation. The primary outcome was the proportion of participants with high cardiovascular risk (10-year risk > 20%). Other measures included questionnaire completion rate and anxiety score. 98% of participants completed the family history questionnaire. The mean increase in proportion of participants classified as having high cardiovascular risk was 4.8 percentage points in the intervention practices, compared with 0.3 percentage point in control practices when family history from patient records was incorporated. The 4.5-percentage point difference between groups (95% CI, 1.7 to 7.2 percentage points) remained significant after adjustment for participant and practice characteristics (P = 0.007). Anxiety scores were similar between groups. Relatively few participants were from ethnic minority or less-educated groups. The potential to explore behavioral change and clinical outcomes was limited. Many data were missing for anxiety scores. Systematically collecting family history increases the proportion of persons identified as having high cardiovascular risk for further targeted prevention and seems to have little or no effect on anxiety. Genetics Health Services Research program of the United Kingdom Department of Health.	1	1	1	1	1	1	0	0	0	0	NA	0	0	1	1	1	1	1	1	12	17	1	1
12	1	Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China.	Enterovirus 71 (EV71) is one of the major causative agents of outbreaks of hand, foot, and mouth disease or herpangina worldwide. This phase 3 trial was designed to evaluate the efficacy, safety, and immunogenicity of an EV71 vaccine. We conducted a randomized, double-blind, placebo-controlled, multicenter trial in which 10,007 healthy infants and young children (6 to 35 months of age) were randomly assigned in a 1:1 ratio to receive two intramuscular doses of either EV71 vaccine or placebo, 28 days apart. The surveillance period was 12 months. The primary end point was the occurrence of EV71-associated hand, foot, and mouth disease or herpangina. During the 12-month surveillance period, EV71-associated disease was identified in 0.3% of vaccine recipients (13 of 5041 children) and 2.1% of placebo recipients (106 of 5028 children) in the intention-to-treat cohort. The vaccine efficacy against EV71-associated hand, foot, and mouth disease or herpangina was 94.8% (95% confidence interval [CI], 87.2 to 97.9; P<0.001) in this cohort. Vaccine efficacies against EV71-associated hospitalization (0 cases vs. 24 cases) and hand, foot, and mouth disease with neurologic complications (0 cases vs. 8 cases) were both 100% (95% CI, 83.7 to 100 and 42.6 to 100, respectively). Serious adverse events occurred in 111 of 5044 children in the vaccine group (2.2%) and 131 of 5033 children in the placebo group (2.6%). In the immunogenicity subgroup (1291 children), an anti-EV71 immune response was elicited by the two-dose vaccine series in 98.8% of participants at day 56. An anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71-associated hand, foot, and mouth disease or herpangina. The EV71 vaccine provided protection against EV71-associated hand, foot, and mouth disease or herpangina in infants and young children. (Funded by Sinovac Biotech; ClinicalTrials.gov number, NCT01507857.).	0	0	1	0	1	1	1	0	1	0	0	0	1	1	1	1	1	1	1	11	18	1	1
13	5	Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia: a randomized clinical trial.	Long-acting injectable antipsychotics are used to reduce medication nonadherence and relapse in schizophrenia-spectrum disorders. The relative effectiveness of long-acting injectable versions of second-generation and older antipsychotics has not been assessed. To compare the effectiveness of the second-generation long-acting injectable antipsychotic paliperidone palmitate with the older long-acting injectable antipsychotic haloperidol decanoate. Multisite, double-blind, randomized clinical trial conducted from March 2011 to July 2013 at 22 US clinical research sites. Randomized patients (n=311) were adults diagnosed with schizophrenia or schizoaffective disorder who were clinically assessed to be at risk of relapse and likely to benefit from a long-acting injectable antipsychotic. Intramuscular injections of haloperidol decanoate 25 to 200 mg or paliperidone palmitate 39 to 234 mg every month for as long as 24 months. Efficacy failure, defined as a psychiatric hospitalization, a need for crisis stabilization, a substantial increase in frequency of outpatient visits, a clinician's decision that oral antipsychotic could not be discontinued within 8 weeks after starting the long-acting injectable antipsychotics, or a clinician's decision to discontinue the assigned long-acting injectable due to inadequate therapeutic benefit. Key secondary outcomes were common adverse effects of antipsychotic medications. There was no statistically significant difference in the rate of efficacy failure for paliperidone palmitate compared with haloperidol decanoate (adjusted hazard ratio, 0.98; 95% CI, 0.65-1.47). The number of participants who experienced efficacy failure was 49 (33.8%) in the paliperidone palmitate group and 47 (32.4%) in the haloperidol decanoate group. On average, participants in the paliperidone palmitate group gained weight and those in the haloperidol decanoate group lost weight; after 6 months, the least-squares mean weight change for those taking paliperidone palmitate was increased by 2.17 kg (95% CI, 1.25-3.09) and was decreased for those taking haloperidol decanoate (-0.96 kg; 95% CI, -1.88 to -0.04). Patients taking paliperidone palmitate had significantly higher maximum mean levels of serum prolactin (men, 34.56 g/L [95% CI, 29.75-39.37] vs 15.41 g/L [95% CI, 10.73-20.08]; P <.001, and for women, 75.19 [95% CI, 63.03-87.36] vs 26.84 [95% CI, 13.29-40.40]; P<.001). Patients taking haloperidol decanoate had significantly larger increases in global ratings of akathisia (0.73 [95% CI, 0.59-0.87] vs 0.45 [95% CI, 0.31-0.59]; P=.006). In adults with schizophrenia or schizoaffective disorder, use of paliperidone palmitate vs haloperidol decanoate did not result in a statistically significant difference in efficacy failure, but was associated with more weight gain and greater increases in serum prolactin, whereas haloperidol decanoate was associated with more akathisia. However, the CIs do not rule out the possibility of a clinically meaningful advantage with paliperidone palmitate. clinicaltrials.gov Identifier: NCT01136772.	1	0	1	0	1	1	1	0	1	0	0	0	0	1	1	1	1	1	0	10	18	1	0
14	4	One year outcomes in patients with acute lung injury randomised to initial trophic or full enteral feeding: prospective follow-up of EDEN randomised trial.	To evaluate the effect of initial low energy permissive underfeeding ("trophic feeding") versus full energy enteral feeding ("full feeding") on physical function and secondary outcomes in patients with acute lung injury. Prospective longitudinal follow-up evaluation of the NHLBI ARDS Clinical Trials Network's EDEN trial 41hospitals in the United States. 525 patients with acute lung injury. Randomised assignment to trophic or full feeding for up to six days; thereafter, all patients still receiving mechanical ventilation received full feeding. Blinded assessment of the age and sex adjusted physical function domain of the SF-36 instrument at 12 months after acute lung injury. Secondary outcome measures included survival; physical, psychological, and cognitive functioning; quality of life; and employment status at six and 12 months. After acute lung injury, patients had substantial physical, psychological, and cognitive impairments, reduced quality of life, and impaired return to work. Initial trophic versus full feeding did not affect mean SF-36 physical function at 12 months (55 (SD 33) v 55 (31), P=0.54), survival to 12 months (65% v 63%, P=0.63), or nearly all of the secondary outcomes. In survivors of acute lung injury, there was no difference in physical function, survival, or multiple secondary outcomes at 6 and 12 month follow-up after initial trophic or full enteral feeding. NCT No 00719446.	1	0	0	0	1	1	1	0	1	1	1	0	0	1	0	0	1	1	0	8	18	0	0

Dataset 1.Dataset for reporting of CONSORT for Abstracts items in articles with and without acknowledged professional medical writing support.

Dataset used per Hays et al.⁹ with the addition of column C for this subanalysis by professional medical writing support (yes: 1; no: 0).

Discussion

Although professional medical writing support was not associated with increased overall adherence to CONSORT for Abstracts, important aspects were improved with professional medical writing support, including reporting of adverse events and funding source. These data confirm prior evidence showing that professional medical writing support is associated with improved safety reporting¹⁵, and serve to support the important role of professional medical writers in promoting adherence to Medical Publishing Insights & Practices recommendations to improve adverse event reporting in clinical trial publications¹⁶. Reporting of funding source was also improved with professional medical writing support, most likely reflecting the emphasis placed on transparency about funding by GPP3 guidelines^5,17. In articles with professional medical writing support, we observed 100% adherence for other important CONSORT for Abstract items, including reporting of the clinical trials registration number (item 18), vital for transparency and study tracking, which has recently been automated using technology such as the TrialsTracker¹⁸.

However, we were disappointed to see that professional medical writing support was not associated with improvements in reporting of other CONSORT for Abstract items, including specification in the title of the design of the study (item 2) and that it was randomized (item 1), and reporting of the numbers randomized and analyzed (items 12 and 13). Indeed, professional medical writing support was actually associated with worse reporting of one item, study setting (item 4). These areas represent clear areas in which professional medical writers can help further improve the reporting of clinical trials in the abstracts of journal articles.

Although this was a post-hoc analysis, it has the advantage that CONSORT for Abstracts adherence was assessed before our study question was posed. Additionally, the presence of professional medical writing support was assigned by an assessor who was blinded to the CONSORT for Abstracts score. However, in the original study, inter-rater agreement for scoring was 84%, which is suboptimal⁹. Furthermore, the original dataset was limited to a sample of high-impact journals, and so may not be generalizable to the biomedical literature as a whole. Indeed, in this dataset of high-impact journals, adherence to CONSORT for Abstracts is likely to have been influenced by the journal’s in-house scientific editing; consequently, the impact of professional medical writing support on adherence to CONSORT for Abstracts may be greater in journals without professional in-house editing. These data were potentially confounded by funding source; because professional medical writing support is typically restricted to industry-funded studies, it is possible that the review processes followed by industry¹⁹, rather than professional medical writing support per se, caused the improvements in reporting that we observed. However, in industry-funded articles, professional medical writing support was associated with a greater than two-fold increase in ≥50% adherence to CONSORT items studied compared with industry-funded articles prepared without this support (38% vs 18%, p<0.05)^7,8. In addition, industry funding alone had no impact on the quality of CONSORT reporting in the absence of professional medical writing support^7,8. Nevertheless, it can be difficult to correctly ascribe the role of the funder from the details provided in manuscripts as, for example, investigator-led studies typically undergo a different review process to those conducted with full industry support²⁰.

In summary, although professional medical writing support was not associated with increased overall adherence to CONSORT for Abstracts, important aspects were improved with professional medical writing support, including reporting of adverse events and funding source. Ensuring adherence to reporting guidelines is a complex task, so we believe that there is a role for reporting professionals such as professional medical writers to work with authors and journals, to provide training, writing and reviewing, and thereby improve the quality of reporting of clinical trials.

Data availability

Dataset 1: Dataset for reporting of CONSORT for Abstracts items in articles with and without acknowledged professional medical writing support. Dataset used per Hays et al.⁹ with the addition of column C for this subanalysis by professional medical writing support (yes: 1; no: 0). doi, 10.5256/f1000research.12268.d172437²¹

Competing interests

Mills I is an employee of PAREXEL International. Sheard C, Hays M, and Douglas K have no disclosures to report. Gattrell WT is an employee of Ipsen Biopharma. Winchester CC is an employee and Director of Oxford PharmaGenesis Ltd, and a Director and shareholder of Oxford PharmaGenesis Holdings Ltd.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Acknowledgments

The authors wish to acknowledge Ronald Gruber, M.S, M.L.S, of QWKINSIGHTS, New York, NY, for early support in the design and conception of this study, and Lindy Dunlop and Megan Misukonis of PAREXEL for editorial assistance.

This study was presented at the 13^th Annual Meeting of ISMPP, May 1–3, 2017, National Harbor, MD, USA.

Faculty Opinions recommended

References

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3. Ghimire S, Kyung E, Kang W, et al.: Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals. Trials. 2012; 13: 77. PubMed Abstract | Publisher Full Text | Free Full Text
4. Hopewell S, Ravaud P, Baron G, et al.: Effect of editors' implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis. BMJ. 2012; 344: e4178. PubMed Abstract | Publisher Full Text | Free Full Text
5. Battisti WP, Wager E, Baltzer L, et al.: Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med. 2015; 163(6): 461–464. PubMed Abstract | Publisher Full Text
6. Kim MR, Nilsen J, Smith G, et al.: Trends in medical writing acknowledgment in medical journals over the last decade. Curr Med Res Opin. 2011; 27(S1): S13. Reference Source
7. Gattrell W, Hopewell S, Young K, et al.: Professional medical writing support improves the quality of reporting of randomized controlled trials. Curr Med Res Opin. 2015; 31(S1): S20. Reference Source
8. Gattrell WT, Hopewell S, Young K, et al.: Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study. BMJ Open. 2016; 6(2): e010329. PubMed Abstract | Publisher Full Text | Free Full Text
9. Hays M, Andrews M, Wilson R, et al.: Reporting quality of randomised controlled trial abstracts among high-impact general medical journals: a review and analysis. BMJ Open. 2016; 6(7): e011082. PubMed Abstract | Publisher Full Text | Free Full Text
10. Hopewell S, Clarke M, Moher D, et al.: CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008; 5(1): e20. PubMed Abstract | Publisher Full Text | Free Full Text
11. Nakazawa M: fmsb:Functions for medical statistics book with some demographic data. R package version 0.5.2. Accessed January 6, 2017. Reference Source
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14. PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology, Hemmes SN, Gama de Abreu M, et al.: High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014; 384(9942): 495–503. PubMed Abstract | Publisher Full Text
15. Jacobs A: Adherence to the CONSORT guideline in papers written by professional medical writers. The Write Stuff. 2010; 19: 196–200. Reference Source
16. Lineberry N, Berlin JA, Mansi B, et al.: Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective. BMJ. 2016; 355: i5078. PubMed Abstract | Publisher Full Text
17. Graf C, Battisti WP, Bridges D, et al.: Research Methods & Reporting. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ. 2009; 339: b4330. PubMed Abstract | Publisher Full Text
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Version 2

VERSION 2 PUBLISHED 16 Aug 2017

Author details Author details

Catherine Sheard
Roles: Data Curation, Formal Analysis, Investigation, Methodology, Software, Visualization, Writing – Review & Editing

Meredith Hays
Roles: Data Curation, Investigation, Writing – Review & Editing

Kevin Douglas
Roles: Data Curation, Investigation, Methodology, Visualization, Writing – Review & Editing

Christopher C. Winchester
Roles: Conceptualization, Investigation, Methodology, Visualization, Writing – Review & Editing

William T. Gattrell
Roles: Conceptualization, Investigation, Methodology, Visualization, Writing – Review & Editing

Competing interests

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (2)

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Published: 14 Sep 2017, 6:1489

https://doi.org/10.12688/f1000research.12268.2

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https://doi.org/10.12688/f1000research.12268.1

© 2017 Mills I et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Data associated with the article are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).

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Mills I, Sheard C, Hays M et al. Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2017, 6:1489 (https://doi.org/10.12688/f1000research.12268.1)

NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.

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Reviewer Report 23 Aug 2017

Jackie M. Marchington, Caudex, Oxford, UK

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https://doi.org/10.5256/f1000research.13282.r25067

This is a subanalysis of a previous study detailing the completeness of clinical study reporting in abstracts according to the CONSORT for abstracts checklist. The original publication was restricted to a sample of clinical trial publications in 5 high-ranking general medical journals. This subanalysis investigated differences in adherence to CONSORT for abstracts between papers with or without acknowledged professional medical writing support.

With respect to the co-authors' previous study, citation of the full paper (ref 8) is sufficient. Citing the poster of the same study is not necessary (ref 7).

Regarding the methods, it is not clear how automated searching would have identified the presence of professional medical writing support. In this reviewer's experience, that has always required retrieval of the full text article. If the automated search was performed on each full text article, I think it would be clearer to state this.

In the discussion, the authors point out funding source as a potential confounder of their results. It would perhaps be of interest to examine industry-funded studies written up without acknowledged professional medical writing support as an additional comparator group to determine whether industry funding was driving differences in CONSORT adherence.

I also have a niggling concern that although GPP3 encourages transparency around the involvement of non-author contributors such as professional medical writers in industry-funded publications, there may be papers in this cohort that used unacknowledged medical writers, papers where a professional writer was included as an author, so not acknowledged as such, or non-industry funded papers where the authors used institutional editorial/writing resource that is not acknowledged. Perhaps the authors could comment on this potential limitation in the discussion.

Although this is a fairly straightforward subanalysis of a previous study, I think it makes an important contribution to the evidence base about the role of professional medical writers, even though the findings are neutral in terms of adherence to CONSORT for abstracts.

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Partly
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Yes

Competing Interests: I work for a company that provides professional medical writing services to pharmaceutical and biotechnology clients. I am active in national and international not-for-profit associations that encourage ethical medical writing practices.

Reviewer Expertise: Professional medical writing, publication ethics

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Author Response 14 Sep 2017

Ira Mills, PAREXEL International, Hackensack, 07601, USA

14 Sep 2017

Author Response

We thank Jackie Marchington for her insight and providing suggestions to improve our paper.

Although Good Publication Practice guidelines (GPP3) encourage transparency of professional medical writing support, it remains ... Continue reading We thank Jackie Marchington for her insight and providing suggestions to improve our paper.

Although Good Publication Practice guidelines (GPP3) encourage transparency of professional medical writing support, it remains possible that professional medical writing support was not consistently acknowledged in the studied dataset, and cited evidence in the literature of its prevalence. Any unacknowledged professional medical writing support would tend towards the null hypothesis enhancing the confidence in the observed statistical differences.

As noted by the referee, we have pointed out funding source as a potential confounder of the results and provided discussion as to some of these considerations. The relatively low number of articles with acknowledged professional medical writing support did not allow us to conduct an analysis of professional medical writing support with and without industry support with any statistical validity.

In our paper to support cited information, we have listed both reference 7 (full publication) and reference 8 (corresponding abstract for a prior congress presentation) as the abstract reported p values not found in the full publication. We have swapped the order of the references to have the full publication cited first.
We thank Jackie Marchington for her insight and providing suggestions to improve our paper.

Although Good Publication Practice guidelines (GPP3) encourage transparency of professional medical writing support, it remains possible that professional medical writing support was not consistently acknowledged in the studied dataset, and cited evidence in the literature of its prevalence. Any unacknowledged professional medical writing support would tend towards the null hypothesis enhancing the confidence in the observed statistical differences.

As noted by the referee, we have pointed out funding source as a potential confounder of the results and provided discussion as to some of these considerations. The relatively low number of articles with acknowledged professional medical writing support did not allow us to conduct an analysis of professional medical writing support with and without industry support with any statistical validity.

In our paper to support cited information, we have listed both reference 7 (full publication) and reference 8 (corresponding abstract for a prior congress presentation) as the abstract reported p values not found in the full publication. We have swapped the order of the references to have the full publication cited first.
Competing Interests: No competing interests were disclosed. Close
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Author Response 14 Sep 2017

Ira Mills, PAREXEL International, Hackensack, 07601, USA

14 Sep 2017

Author Response

We thank Jackie Marchington for her insight and providing suggestions to improve our paper.

Although Good Publication Practice guidelines (GPP3) encourage transparency of professional medical writing support, it remains ... Continue reading We thank Jackie Marchington for her insight and providing suggestions to improve our paper.

Although Good Publication Practice guidelines (GPP3) encourage transparency of professional medical writing support, it remains possible that professional medical writing support was not consistently acknowledged in the studied dataset, and cited evidence in the literature of its prevalence. Any unacknowledged professional medical writing support would tend towards the null hypothesis enhancing the confidence in the observed statistical differences.

As noted by the referee, we have pointed out funding source as a potential confounder of the results and provided discussion as to some of these considerations. The relatively low number of articles with acknowledged professional medical writing support did not allow us to conduct an analysis of professional medical writing support with and without industry support with any statistical validity.

In our paper to support cited information, we have listed both reference 7 (full publication) and reference 8 (corresponding abstract for a prior congress presentation) as the abstract reported p values not found in the full publication. We have swapped the order of the references to have the full publication cited first.
We thank Jackie Marchington for her insight and providing suggestions to improve our paper.

Although Good Publication Practice guidelines (GPP3) encourage transparency of professional medical writing support, it remains possible that professional medical writing support was not consistently acknowledged in the studied dataset, and cited evidence in the literature of its prevalence. Any unacknowledged professional medical writing support would tend towards the null hypothesis enhancing the confidence in the observed statistical differences.

As noted by the referee, we have pointed out funding source as a potential confounder of the results and provided discussion as to some of these considerations. The relatively low number of articles with acknowledged professional medical writing support did not allow us to conduct an analysis of professional medical writing support with and without industry support with any statistical validity.

In our paper to support cited information, we have listed both reference 7 (full publication) and reference 8 (corresponding abstract for a prior congress presentation) as the abstract reported p values not found in the full publication. We have swapped the order of the references to have the full publication cited first.
Competing Interests: No competing interests were disclosed. Close
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Reviewer Report 17 Aug 2017

Ana Marusic, Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia

Approved with Reservations

https://doi.org/10.5256/f1000research.13282.r25066

This study presents secondary analysis of a study of adherence to CONSORT reporting guidelines for Abstracts. While the original study (Hays et al, 2016) looked at this adherence in a sample of abstracts from several high-profile medical journals, this study performed a subgroup analysis, looking at whether the mention of professional writing assistance was associated with the score for different items on the reporting checklist. The study is thus quite methodologically biased, and it is not clear whether the observed differences are real, or random. For example, the finding that the acknowledgment of professional writing assistance decreases the frequency of adequately reporting the setting of the study is difficult to explain. The potential randomness of the significant findings should be addressed in the Discussion section.

Making a publication out of the original publication by looking at a single characteristic does not really warrant the publication of the submitted manuscript. It would be preferable if other characteristics were explored in relation to reporting completeness in abstracts, such as the type of funding, phase of the trial, institutions where trials were performed.

The manuscript is well written and structured, and there are no major comments or suggestions for improvement except the conceptual one described above. In the Methods section, the extraction of data for this study is not fully explained - how many experts extracted the data, how were different terms in the statements on writing assistance interpreted and categorized, etc.

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

No
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Dissemination bias, publication integrity

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Author Response 14 Sep 2017

Ira Mills, PAREXEL International, Hackensack, 07601, USA

14 Sep 2017

Author Response

We thank Ana Marušić for her insight and providing suggestions to improve our paper.

We feel that the data described herein fulfill the criteria for publication as a “Research ... Continue reading We thank Ana Marušić for her insight and providing suggestions to improve our paper.

We feel that the data described herein fulfill the criteria for publication as a “Research Note” in F1000 Research, designed to report “single-finding papers that can be reported with one or two illustrations.” Our intention was to conduct a post hoc analysis to specifically examine the role of professional medical writing support on CONSORT adherence as previously described by two of the authors.

In the discussion, we acknowledge that there was substantial risk of false positives given that separate confidence intervals were computed for 19 different CONSORT items. However, the p value for setting (item 4) was 0.0010, for harms or side effects (item 16) was 0.0004, and for source of funding (item 19) was 0.0055; the first two survive a Bonferroni correction, which would conservatively demand that p<0.0026, and all three pass the less stringent Benjamini-Hochberg procedure.

We now include a note in the discussion that the limited number of articles with acknowledged professional medical writing support did not allow further exploration of the results (e.g. type of funding, trial phase, institutions where performed) and also mention that it would be of interest to examine whether similar trends are observed in separate studies of CONSORT for Abstracts.

As described in the original submission, one author performed the data extraction conducting a blinded automated search per the defined terms followed by reexamining for context. We note two articles that were excluded from the analysis by manual review and provide rationale. In one case there was no writing assistance from anyone not listed as an author and in the second case the “Writing committee drafted the report…without editorial assistance.” We have made it clear that this was performed using the full text articles.
We thank Ana Marušić for her insight and providing suggestions to improve our paper.

We feel that the data described herein fulfill the criteria for publication as a “Research Note” in F1000 Research, designed to report “single-finding papers that can be reported with one or two illustrations.” Our intention was to conduct a post hoc analysis to specifically examine the role of professional medical writing support on CONSORT adherence as previously described by two of the authors.

In the discussion, we acknowledge that there was substantial risk of false positives given that separate confidence intervals were computed for 19 different CONSORT items. However, the p value for setting (item 4) was 0.0010, for harms or side effects (item 16) was 0.0004, and for source of funding (item 19) was 0.0055; the first two survive a Bonferroni correction, which would conservatively demand that p<0.0026, and all three pass the less stringent Benjamini-Hochberg procedure.

We now include a note in the discussion that the limited number of articles with acknowledged professional medical writing support did not allow further exploration of the results (e.g. type of funding, trial phase, institutions where performed) and also mention that it would be of interest to examine whether similar trends are observed in separate studies of CONSORT for Abstracts.

As described in the original submission, one author performed the data extraction conducting a blinded automated search per the defined terms followed by reexamining for context. We note two articles that were excluded from the analysis by manual review and provide rationale. In one case there was no writing assistance from anyone not listed as an author and in the second case the “Writing committee drafted the report…without editorial assistance.” We have made it clear that this was performed using the full text articles.
Competing Interests: No competing interests were disclosed. Close
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COMMENTS ON THIS REPORT

Author Response 14 Sep 2017

Ira Mills, PAREXEL International, Hackensack, 07601, USA

14 Sep 2017

Author Response

We thank Ana Marušić for her insight and providing suggestions to improve our paper.

We feel that the data described herein fulfill the criteria for publication as a “Research ... Continue reading We thank Ana Marušić for her insight and providing suggestions to improve our paper.

We feel that the data described herein fulfill the criteria for publication as a “Research Note” in F1000 Research, designed to report “single-finding papers that can be reported with one or two illustrations.” Our intention was to conduct a post hoc analysis to specifically examine the role of professional medical writing support on CONSORT adherence as previously described by two of the authors.

In the discussion, we acknowledge that there was substantial risk of false positives given that separate confidence intervals were computed for 19 different CONSORT items. However, the p value for setting (item 4) was 0.0010, for harms or side effects (item 16) was 0.0004, and for source of funding (item 19) was 0.0055; the first two survive a Bonferroni correction, which would conservatively demand that p<0.0026, and all three pass the less stringent Benjamini-Hochberg procedure.

We now include a note in the discussion that the limited number of articles with acknowledged professional medical writing support did not allow further exploration of the results (e.g. type of funding, trial phase, institutions where performed) and also mention that it would be of interest to examine whether similar trends are observed in separate studies of CONSORT for Abstracts.

As described in the original submission, one author performed the data extraction conducting a blinded automated search per the defined terms followed by reexamining for context. We note two articles that were excluded from the analysis by manual review and provide rationale. In one case there was no writing assistance from anyone not listed as an author and in the second case the “Writing committee drafted the report…without editorial assistance.” We have made it clear that this was performed using the full text articles.
We thank Ana Marušić for her insight and providing suggestions to improve our paper.

We feel that the data described herein fulfill the criteria for publication as a “Research Note” in F1000 Research, designed to report “single-finding papers that can be reported with one or two illustrations.” Our intention was to conduct a post hoc analysis to specifically examine the role of professional medical writing support on CONSORT adherence as previously described by two of the authors.

In the discussion, we acknowledge that there was substantial risk of false positives given that separate confidence intervals were computed for 19 different CONSORT items. However, the p value for setting (item 4) was 0.0010, for harms or side effects (item 16) was 0.0004, and for source of funding (item 19) was 0.0055; the first two survive a Bonferroni correction, which would conservatively demand that p<0.0026, and all three pass the less stringent Benjamini-Hochberg procedure.

We now include a note in the discussion that the limited number of articles with acknowledged professional medical writing support did not allow further exploration of the results (e.g. type of funding, trial phase, institutions where performed) and also mention that it would be of interest to examine whether similar trends are observed in separate studies of CONSORT for Abstracts.

As described in the original submission, one author performed the data extraction conducting a blinded automated search per the defined terms followed by reexamining for context. We note two articles that were excluded from the analysis by manual review and provide rationale. In one case there was no writing assistance from anyone not listed as an author and in the second case the “Writing committee drafted the report…without editorial assistance.” We have made it clear that this was performed using the full text articles.
Competing Interests: No competing interests were disclosed. Close
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VERSION 2 PUBLISHED 16 Aug 2017

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Ana Marusic, University of Split School of Medicine, Split, Croatia
Jackie M. Marchington, Caudex, Oxford, UK

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22 Sep 2017 | for Version 2

Ana Marusic, Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia

17 Views Cite this report Responses(0)

Approved

The authors have addressed my concerns and comments. Although the information presented is rather obvious and based on a previous study, it is important evidence in the field and is suitable for indexing as a research note.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Dissemination bias, publication integrity

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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18 Sep 2017 | for Version 2

Jackie M. Marchington, Caudex, Oxford, UK

16 Views Cite this report Responses(0)

Approved

I have no further comments. Thank you.

Competing Interests

As previously stated.

Reviewer Expertise

Professional medical writing, publication ethics

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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27 Views

23 Aug 2017 | for Version 1

Jackie M. Marchington, Caudex, Oxford, UK

27 Views Cite this report Responses(1)

Approved

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Partly
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Yes

Competing Interests

I work for a company that provides professional medical writing services to pharmaceutical and biotechnology clients. I am active in national and international not-for-profit associations that encourage ethical medical writing practices.

Reviewer Expertise

Professional medical writing, publication ethics

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Respond to this report

Responses (1)

Author Response

14 Sep 2017

Ira Mills, PAREXEL International, Hackensack, 07601, USA

We thank Jackie Marchington for her insight and providing suggestions to improve our paper.

Although Good Publication Practice guidelines (GPP3) encourage transparency of professional medical writing support, it remains possible that professional medical writing support was not consistently acknowledged in the studied dataset, and cited evidence in the literature of its prevalence. Any unacknowledged professional medical writing support would tend towards the null hypothesis enhancing the confidence in the observed statistical differences.

As noted by the referee, we have pointed out funding source as a potential confounder of the results and provided discussion as to some of these considerations. The relatively low number of articles with acknowledged professional medical writing support did not allow us to conduct an analysis of professional medical writing support with and without industry support with any statistical validity.

In our paper to support cited information, we have listed both reference 7 (full publication) and reference 8 (corresponding abstract for a prior congress presentation) as the abstract reported p values not found in the full publication. We have swapped the order of the references to have the full publication cited first.

View more View less

Competing Interests

No competing interests were disclosed.

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Reviewer Report

26 Views

17 Aug 2017 | for Version 1

Ana Marusic, Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia

26 Views Cite this report Responses(1)

Approved With Reservations

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

No
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Dissemination bias, publication integrity

Respond to this report

Responses (1)

Author Response

14 Sep 2017

Ira Mills, PAREXEL International, Hackensack, 07601, USA

We thank Ana Marušić for her insight and providing suggestions to improve our paper.

We feel that the data described herein fulfill the criteria for publication as a “Research Note” in F1000 Research, designed to report “single-finding papers that can be reported with one or two illustrations.” Our intention was to conduct a post hoc analysis to specifically examine the role of professional medical writing support on CONSORT adherence as previously described by two of the authors.

In the discussion, we acknowledge that there was substantial risk of false positives given that separate confidence intervals were computed for 19 different CONSORT items. However, the p value for setting (item 4) was 0.0010, for harms or side effects (item 16) was 0.0004, and for source of funding (item 19) was 0.0055; the first two survive a Bonferroni correction, which would conservatively demand that p<0.0026, and all three pass the less stringent Benjamini-Hochberg procedure.

We now include a note in the discussion that the limited number of articles with acknowledged professional medical writing support did not allow further exploration of the results (e.g. type of funding, trial phase, institutions where performed) and also mention that it would be of interest to examine whether similar trends are observed in separate studies of CONSORT for Abstracts.

As described in the original submission, one author performed the data extraction conducting a blinded automated search per the defined terms followed by reexamining for context. We note two articles that were excluded from the analysis by manual review and provide rationale. In one case there was no writing assistance from anyone not listed as an author and in the second case the “Writing committee drafted the report…without editorial assistance.” We have made it clear that this was performed using the full text articles.

View more View less

Competing Interests

No competing interests were disclosed.

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Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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[1] 1. Hopewell S, Dutton S, Yu LM, et al.: The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ. 2010; 340: c723. PubMed Abstract | Publisher Full Text | Free Full Text

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[14] 14. PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology, Hemmes SN, Gama de Abreu M, et al.: High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014; 384(9942): 495–503. PubMed Abstract | Publisher Full Text

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[17] 17. Graf C, Battisti WP, Bridges D, et al.: Research Methods & Reporting. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ. 2009; 339: b4330. PubMed Abstract | Publisher Full Text

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Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals

Abstract

Keywords

Introduction

Methods

Table 1. CONSORT for Abstracts checklist items10, with descriptors by Hays et al.9 as used for this subanalysis.

Results

Figure 1. Reporting of CONSORT for Abstracts items in articles with and without acknowledged professional medical writing support.

Discussion

Data availability

Competing interests

Grant information

Acknowledgments

References

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Table 1. CONSORT for Abstracts checklist items¹⁰, with descriptors by Hays et al.⁹ as used for this subanalysis.