Completeness and Changes in Registered Data and Reporting Bias of Randomized Controlled Trials in ICMJE Journals after Trial Registration Policy

Abstract Background Few clinical trials have investigated the prevention of radiographic progression in children with juvenile idiopathic arthritis treated with antirheumatic drugs. This study aimed to investigate radiographic progression in patients with systemic juvenile idiopathic arthritis (sJIA) and patients with polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with the anti–interleukin-6 receptor antibody tocilizumab for 2 years in the TENDER and CHERISH randomized controlled trials, respectively. Methods Standard radiographs of both wrists and both hands in the posteroanterior view were obtained within 4 weeks of baseline and were repeated at weeks 52 ± 4 and 104 ± 4 in both trials. All films were scored by two independent readers using the adapted Sharp–van der Heijde (aSH) and Poznanski scoring methods. Although the Poznanski score indicates bone growth limitation or cartilage growth decrease, which are not the same as joint space narrowing in rheumatoid arthritis, its change reflects damage to cartilage. Therefore, impairment in the Poznanski score as well as the aSH score was considered as a measure of structural joint damage. Radiographic progression was defined as worsening of radiographic scores beyond the smallest detectable difference. Results Poznanski and aSH scores were available at baseline and at one or more postbaseline time points for 33 and 47 of 112 sJIA patients and 61 and 87 of 188 pcJIA patients, respectively, providing a representative subset of the study populations. The inter-reader and intra-reader agreement intra-class correlation coefficient was > 0.8. Median baseline Poznanski and aSH scores, respectively, were − 2.4 and 24.6 for sJIA patients and − 1.5 and 8.0 for pcJIA patients. Compared with baseline, aSH scores remained stable for all sJIA patients at week 52, whereas 9.4% of sJIA patients had radiographic progression according to Poznanski scores at week 52; at 104 weeks, radiographic progression according to aSH and Poznanski scores was observed in 5.4% and 11.5%, respectively. In pcJIA patients, radiographic progression from baseline at 52 weeks and at 104 weeks was 12.5% and 2.9%, respectively, using aSH scoring and 6.5% and 4%, respectively, using Poznanski scoring. Conclusion Tocilizumab may delay radiographic progression in children with sJIA and children with pcJIA. Trial registration Trial registration numbers and dates: TENDER, NCT00642460 (March 19, 2008); CHERISH, NCT00988221 (October 1, 2009)

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Outcome reporting bias in randomized-controlled trials investigating antipsychotic drugs

Translational Psychiatry ◽

10.1038/tp.2017.203 ◽

2017 ◽

Vol 7 (9) ◽

pp. e1232-e1232 ◽

Cited By ~ 17

Author(s):

M Lancee ◽

C M C Lemmens ◽

R S Kahn ◽

C H Vinkers ◽

J J Luykx

Keyword(s):

Randomized Controlled Trials ◽

Antipsychotic Drugs ◽

Reporting Bias ◽

Controlled Trials ◽

Outcome Reporting Bias ◽

Outcome Reporting ◽

Randomized Controlled

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Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis

BMC Medical Research Methodology ◽

10.1186/s12874-020-01140-6 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Jane M. Fletcher ◽

Terry Saunders-Smith ◽

Braden J. Manns ◽

Ross Tsuyuki ◽

Brenda R. Hemmelgarn ◽

...

Keyword(s):

Focus Groups ◽

Randomized Controlled Trials ◽

Low Income ◽

Intrinsic Value ◽

Trial Registration ◽

Controlled Trials ◽

Patient Recruitment ◽

Large Trial ◽

Recruitment Strategies ◽

Randomized Controlled

Abstract Background Although recruitment is a major challenge for most randomized controlled trials, few report on the difficulties of recruitment, or how it might be enhanced. The objective of our study was to qualitatively explore the experiences of both patients and pharmacists related to recruitment for ACCESS, a large trial involving low-income seniors, given that two of our most successful recruitment strategies were direct patient recruitment materials and use of community pharmacists. Methods Using qualitative descriptive methods, we collected data from pharmacists and study participants. Pharmacists were asked about their impressions of the study, as well as challenges they faced and methods they used to recruit potential participants. Focus groups with trial participants centered on the patient recruitment materials. Interviews and focus groups were recorded, transcribed and analyzed using thematic analysis. Results Pharmacists noted that their first impressions of the study were positive as they described being enticed to help the study team by the potential benefit of copayment elimination for their patients and the low time commitment. Pharmacists noted they were more likely to recruit if they were well informed on the study, as they could answer their patients’ questions. Participants noted that their primary motivations for participating were the tangible benefits of free medications and the intrinsic value of participating in research. Conclusions We noted that recruitment through pharmacies was an effective method as most patients have trusting relationships with their pharmacist. To optimize recruitment through pharmacies, study procedures should be straightforward, and pharmacists need to be equipped with good knowledge of the study. When promoting a study to potential participants, messaging should ensure the individuals are aware of the tangible benefits of participation while still presenting a full overview of the trial. Trial registration Trial Registration Number: NCT02579655 – initially registered Oct 19, 2015.

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