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Table 2 Summary of results

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

First author, year

Outcome measured

Effect of PMWS

Positive

Non-significant

Negative

Gattrell, 2016 [15]

Adherence to CONSORT guidelines

The proportion of articles that completely reported at least 50% of the assessed CONSORT items

• With PMWS: 43/110 articles (39.1%; 95% CI 29.9–48.9)

• Without PMWS: 26/123 articles (21.1%; 95% CI 14.3–29.4)

  

Jacobs, 2010 [16]

Logistic regression analysis showed that CONSORT items were significantly more likely to be completed in papers with a clear acknowledgement of PMWS than in those without (OR 1.44; 95% CI 1.04–2.00; p = 0.03)

  

Shah, 2015 [20]

23/97 articles with PMWS (24%) had 80–100% CONSORT adherence, whereas 5/105 articles developed without PMWS (5%) had 80–100% CONSORT adherence (p < 0.0001)

  

Mills, 2017 [14]

Adherence to CONSORT-A guidelines

 

The mean proportion of CONSORT-A items reported was similar with and without PMWS (64.3% vs 66.5%, respectively; p = 0.30); PMWS was associated with a lower level of compliance with reporting of study setting (RR 0.40; 95% CI 0.23–0.70) and a higher level of adherence to disclosure of harms/side effects (RR 2.04; 95% CI 1.37–3.03) and funding source (RR 1.75; 95% CI 1.18–2.60)

 

Gattrell, 2016 [15]

Quality of written English

Proportion of articles rated by all reviewers during peer review as having an acceptable standard of written English

• With PMWS: 81.1% (43/53 articles; 95% CI 67.6–90.1)

• Without PMWS: 47.9% (23/48 articles; 95% CI 33.5–62.7)

  

Gattrell, 2016 [18]

Publication in journal with an impact factor

Likelihood of publication in journal with an impact factor was significantly improved with PMWS (p = 0.001)

  

Mean impact factor of publication

Mean impact factor of publication was significantly improved with PMWS (p < 0.001)

  

Gattrell, 2017 [17]

Reporting of non-pre-specified outcomes

Articles developed with PMWS reported fewer non-pre-specified outcomes than both industry-funded (p = 0.028) and non-industry-funded articles (p < 0.01) developed without PMWS

  

Gattrell, 2016 [18]

Mean number of citations per year

 

Mean number of citations per year was not significantly improved with PMWS (p = 0.11)

 

Mean number of article views per year

 

Mean number of article views per year was not significantly improved with PMWS (p = 0.84)

 

Altmetric score

 

Altmetric score was not significantly improved with PMWS (p = 0.55)

 

Gattrell, 2016 [15]

Manuscript acceptance time

  

Time from manuscript submission to acceptance was increased with PMWS (167 days [IQR 114.5–231 days] vs 136 days [IQR 77–193 days], p < 0.01); mean number of versions submitted was unchanged

Shah, 2016 [19]

Time to publication

Time to publication from last patient visit in clinical trials was reduced with PMWS (18.6 [SD 13.2] months vs 30.8 [SD 11.7] months)

  

Woolley, 2006 [8]

Manuscript acceptance time

 

Time from manuscript submission to acceptance was reduced with PMWS (83.6 days vs 132.2 days), although this difference was not statistically significant (p = 0.053)

 
  1. CI confidence interval, CONSORT Consolidated Standards of Reporting Trials, CONSORT-A CONSORT for Abstracts, IQR interquartile range, OR odds ratio, PMWS professional medical writing support, RR relative risk, SD standard deviation