scholarly journals 1379Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement?

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Aidan Tan ◽  
Zet Tan ◽  
Tom Li ◽  
Ian Harris ◽  
Justine Naylor ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
English Language ◽  
Controlled Trial ◽  
Reporting Quality ◽  
Recent Period ◽  
Before And After ◽  
Trial Protocols ◽  
Randomised Controlled ◽  
The Impact

Abstract Background The impact of the SPIRIT statement on the reporting quality of RCT protocols in health research is unknown. This methodological study aimed to determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the SPIRIT statement, and any association with author, trial or journal factors. Methods RCT protocols were identified by searching MEDLINE, Embase and CENTRAL, included if published in full-text, English language and a peer-reviewed journal, and assessed with the SPIRIT statement checklist items. Results 300 RCT protocols were retrieved; 150 from the period immediately before the SPIRIT statement and 150 from a recent period after the SPIRIT statement. 47.9% (95% CI, 46.5% to 49.3%) of checklist items were adequately reported in RCT protocols before the SPIRIT statement and 56.7% (95% CI, 54.9% to 58.5%) after the SPIRIT statement. This represents an 8.8% (95% CI, 6.6% to 11.1%; p < 0.0001) mean improvement in the overall proportion of checklist items adequately reported since the SPIRIT statement. The factors associated with higher reporting quality of RCT protocols in multiple regression analysis were author expertise or experience in epidemiology or statistics, multicentre trials, longer protocol word length and publicly reported journal policy of compliance with the SPIRIT statement. Conclusions The overall reporting quality of RCT protocols has significantly improved since the SPIRIT statement, although a substantial proportion of individual checklist items remain poorly reported. Key messages Continued, concerted and coordinated efforts are required by journals, editors, reviewers and investigators to improve the completeness and transparency of RCT protocols.

scholarly journals Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e038283
Author(s):  
Zet Wei Tan ◽  
Aidan Christopher Tan ◽  
Tom Li ◽  
Ian Harris ◽  
Justine M Naylor ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
English Language ◽  
Controlled Trial ◽  
Reporting Quality ◽  
Methodological Study ◽  
Eligibility Criteria ◽  
Significant Deterioration ◽  
Before And After ◽  
Randomised Controlled

ObjectivesTo determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (2013), and any association with author, trial or journal factors.DesignMethodological study.Data sourcesMEDLINE, Embase and CENTRAL were electronically searched using optimised search strategies.Eligibility criteriaProtocols written for an RCT of living humans, published in full text in a peer-reviewed journal and published in the English language.Main outcomePrimary outcome was the overall proportion of checklist items which were adequately reported in RCT protocols published before and after the SPIRIT statement.Results300 RCT protocols were retrieved; 150 from the period immediately before the SPIRIT statement (9 July 2012 to 28 December 2012) and 150 from a recent period after the SPIRIT statement (25 January 2019 to 20 March 2019). 47.9% (95% CI, 46.5% to 49.3%) of checklist items were adequately reported in RCT protocols before the SPIRIT statement and 56.7% (95% CI, 54.9% to 58.5%) after the SPIRIT statement. This represents an 8.8% (95% CI, 6.6% to 11.1%; p<0.0001) mean improvement in the overall proportion of checklist items adequately reported since the SPIRIT statement. While 40% of individual checklist items had a significant improvement in adequate reporting after the SPIRIT statement, 11.3% had a significant deterioration and there were no RCT protocols in which all individual checklist items were complete. The factors associated with higher reporting quality of RCT protocols in multiple regression analysis were author expertise or experience in epidemiology or statistics, multicentre trials, longer protocol word length and publicly reported journal policy of compliance with the SPIRIT statement.ConclusionThe overall reporting quality of RCT protocols has significantly improved since the SPIRIT statement, although a substantial proportion of individual checklist items remain poorly reported. Continued and concerted efforts are required by journals, editors, reviewers and investigators to improve the completeness and transparency of RCT protocols.

scholarly journals Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial

2020 ◽  
Vol 7 (1) ◽  
pp. e000376
Author(s):  
Sivakami Janahiraman ◽  
Chan Yen Tay ◽  
Jie Min Lee ◽  
Wen Ling Lim ◽  
Chun Hoe Khiew ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Educational Programme ◽  
Control Group ◽  
Randomised Controlled ◽  
The Impact ◽  
Experimental Group

ObjectivePreprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.DesignAn accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).ResultsA total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).ConclusionAn intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.

The impact of physical activity on fatigue and quality of life in lung cancer patients: A randomised controlled trial (RCT).

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 9507-9507 ◽  
Author(s):  
Janette L. Vardy ◽  
Melanie Bell ◽  
Hidde van der Ploeg ◽  
Jane Turner ◽  
Michael Kabourakis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Lung Cancer ◽  
Randomised Controlled Trial ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Lung Cancer Patients ◽  
Randomised Controlled ◽  
The Impact

scholarly journals Evaluation of teaching an integrated case formulation approach on the quality of case formulations: randomised controlled trial

2012 ◽  
Vol 36 (4) ◽  
pp. 140-145 ◽  
Author(s):  
Mohammed Abbas ◽  
Ruth Walton ◽  
Allan Johnston ◽  
Millicent Chikoore
Keyword(s):  
Randomised Controlled Trial ◽  
Rating Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Case Formulation ◽  
New Approach ◽  
Before And After ◽  
Randomised Controlled

Aims and methodThis paper introduces a new approach to producing case formulations, the integrated case formulation (ICF) approach, and a rating scale, the Case Formulation Scale (CFS). Twenty-four psychiatrists participated in a single-blind randomised controlled trial to evaluate the effectiveness of teaching using this new approach. The intervention group (n = 12) received teaching about using ICF, whereas the control group (n = 12) received teaching as usual. The scores on the CFS were compared before and after teaching.ResultsPrior to teaching, psychiatric trainees had poor scores on the CFS. The CFS score for the group taught the ICF approach improved five times more than the control group.Clinical implicationsThis study demonstrates that case formulation skills can be taught. With further improvements, the ICF approach might be useful in the teaching of case formulation.

Stroke rehabilitation at home before and after discharge reduced disability and improved quality of life: a randomised controlled trial

2015 ◽  
Vol 30 (3) ◽  
pp. 225-236 ◽  
Author(s):  
Rune Skovgaard Rasmussen ◽  
Ann Østergaard ◽  
Pia Kjær ◽  
Anja Skerris ◽  
Christina Skou ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Stroke Rehabilitation ◽  
Controlled Trial ◽  
Before And After ◽  
Randomised Controlled ◽  
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