Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review

Milette, Katherine; Roseman, Michelle; Thombs, Brett D.

doi:10.1016/j.jpsychores.2010.09.015

Cited by 58 publications

(70 citation statements)

References 107 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Milette et al [16] reviewed articles published between January 2008 and October 2009 in 4 journals that had been identified previously as "leading psychosomatic and behavioral medicine journals" (p. 206) (Annals of Behavioural Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine) [24]. In the present study, we sought RCTs published in the same 4 journals 5 years later, from January 2013 through October 2014.…”

Section: Article Selectionmentioning

confidence: 99%

“…Based on the ICMJE definition of clinical trials [13], which has been used in previous studies of RCT registrations [16,25], articles were included if they reported data from any RCT that randomly assigned participants to intervention and comparison groups to study the cause-and-effect relationship between an intervention and a health outcome. Articles that reported analyses of secondary trial outcomes, including subgroup analyses, were included.…”

Section: Article Selectionmentioning

confidence: 99%

“…We followed a procedure outlined by Mathieu et al [25], which was also used by Milette et al [16]. First, we attempted to retrieve trial registration data, including registration number, from each published article.…”

Section: Objective 2 -Trial Registrationmentioning

confidence: 99%

“…First, using the same method as Milette et al [16], registered studies were classified as having adequately or inadequately registered outcomes. Adequately registered studies had to meet 2 criteria, based on ICMJE policy: (1) Studies ongoing as of July 1st, 2005 had to be registered prior to September 13th, 2005 and prior to trial completion.…”

Section: Objective 2 -Trial Registrationmentioning

confidence: 99%

“…The existence of selective reporting biases in published trial reports is well-documented. One review evaluated 16 studies that compared trial protocols or trial Journal of Psychosomatic Research 79 (2015) [1][2][3][4][5][6][7][8][9][10][11][12] RCTs according to the methods used in Milette et al [16] and the SPIRIT 2013 guidelines; (3) evaluate whether published primary outcomes were consistent with registered primary outcomes; and (4) compare the proportion of published RCTs with clearly defined outcomes and adequate pre-trial registration to results obtained by Milette et al [16] 5 years ago.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A 5-year follow-up

Riehm

Azar

Thombs

2015

Journal of Psychosomatic Research

View full text Add to dashboard Cite

show abstract

Section: Article Selectionmentioning

confidence: 99%

Section: Article Selectionmentioning

confidence: 99%

Section: Objective 2 -Trial Registrationmentioning

confidence: 99%

Section: Objective 2 -Trial Registrationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A 5-year follow-up

Riehm

Azar

Thombs

2015

Journal of Psychosomatic Research

View full text Add to dashboard Cite

show abstract

Evaluation of Journal Registration Policies and Prospective Registration of Randomized Clinical Trials of Nonregulated Health Care Interventions

et al. 2019

Self Cite

View full text Add to dashboard Cite

IMPORTANCE Many interventions that are important to the health care of patients are not subject to regulation by the US Food and Drug Administration (FDA) or comparable regulatory bodies in other nations. OBJECTIVE To determine whether specialty journals that publish trials of primarily nonregulated health care interventions require prospective registration and whether the prospective registration policies are associated with the publication of prospectively registered trials, trials with adequately registered outcomes, and trials with primary outcomes consistent with the registered primary outcomes. DESIGN AND METHODS PubMed was searched daily, from March 18, 2016, to September 17, 2016, for nonregulated intervention randomized clinical trials. The search included all journals in the Clarivate Analytics Science Citation Index Expanded categories of behavioral sciences, nursing, nutrition and dietetics, psychology, rehabilitation, and surgery. Trials of interventions not subject to FDA regulation were included. One investigator extracted journal registration policy and trial registration status. Two investigators independently extracted trial registration and publication characteristics. MAIN OUTCOMES AND MEASURES For journals, the main outcome was the trial registration policy. For trials, the main outcomes were prospective registration, adequacy of outcome registration, and concordance of registered with published primary outcomes. RESULTS In total, 953 nonregulated intervention trials published in 254 journals were identified. Prospective registration was required for publication by 29 (11.4%) of 254 journals, and an additional 12 journals (4.7%) had conditional date-based requirements. Only 189 (19.8%) of the 953 trials were registered prospectively, including 33 of 98 published in journals with prospective registration policies as compared with 156 of 855 in journals without policies (33.7% vs 18.2%; P = .004). Among the 17 journals that required prospective registration and had at least 2 included trials, none had a prospective registration of more than 50%. In journals with policies, only 3 of 98 trials included primary outcomes consistent with prospectively, adequately registered outcomes, as compared with 34 of 852 trials in journals without policies (3.1% vs 4.0%; P = .62). CONCLUSIONS AND RELEVANCE Few journals in behavioral sciences or psychology, nursing, nutrition and dietetics, rehabilitation, and surgery require prospective trial registration, and those with existing registration policies rarely enforce them; this finding suggests that strategies for encouraging prospective registration of clinical trials not subject to FDA regulation should be developed and tested.

show abstract

Comparison of Clinical Trial Changes in Primary Outcome and Reported Intervention Effect Size Between Trial Registration and Publication

Chen

Qin

et al. 2019

JAMA Netw Open

View full text Add to dashboard Cite

Key Points Question Does primary outcome change between trial registration and publication alter a randomized clinical trial’s reported intervention effect size? Findings In this cross-sectional study that included 389 trials, 130 of them had at least 1 primary outcome change between registration and publication. This significantly overestimated the reported intervention effect size by 16% compared with those without primary outcome change. Meaning Inconsistencies between registered and published primary outcomes in clinical trials are common, with a larger reported intervention effect size among those with primary outcome change than those without.

show abstract

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review

Cited by 58 publications

References 107 publications

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A 5-year follow-up

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A 5-year follow-up

Evaluation of Journal Registration Policies and Prospective Registration of Randomized Clinical Trials of Nonregulated Health Care Interventions

Comparison of Clinical Trial Changes in Primary Outcome and Reported Intervention Effect Size Between Trial Registration and Publication

Contact Info

Product

Resources

About