CONSORT extension for reporting N-of-1 trials (CENT) 2015: Explanation and elaboration

Shamseer, Larissa; Sampson, Margaret; Bukutu, Cecilia; Schmid, Christopher H.; Nikles, Jane; Tate, Robyn; Johnston, Bradley C.; Zucker, Deborah; Shadish, William R.; Kravitz, Richard L.; Guyatt, Gordon; Altman, Douglas G.; Moher, David; Vohra, Sunita

doi:10.1136/bmj.h1793

Cited by 144 publications

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“…These can be found in the CENT 2015 Explanation and Elaboration (E&E) document. 24 The principles addressed in this document were largely derived from existing literature, the CON-SORT 2010 E&E document 8 where applicable, and from discussions at the CENT meeting, which was recorded and summarised.…”

Section: Cent 2015 Explanation and Elaboration (Eande) Documentmentioning

confidence: 99%

CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement

Vohra

Shamseer

Sampson

et al. 2015

BMJ

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Section: Cent 2015 Explanation and Elaboration (Eande) Documentmentioning

confidence: 99%

CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement

Vohra

Shamseer

Sampson

et al. 2015

BMJ

Self Cite

182

144

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“…These can be found in the CENT 2015 E&E document [24]. The principles addressed in this document were largely derived from existing literature, the CONSORT 2010 E&E document [8] where applicable, and from discussions at the CENT meeting, which was recorded and summarized.…”

Section: Cent 2015 Eande Documentmentioning

confidence: 99%

“…Authors are urged to read and use the CENT 2015 E&E document together with the checklist, as it provides examples of good reporting and evidence and consensusbased rationale and guidance on how to report each item [24].…”

Section: Cent 2015 Eande Documentmentioning

confidence: 99%

“…Authors are encouraged in include the relevant diagram(s) in their N-of-1 reports. Specific guidance on the information that should be included in each diagram is provided in the CENT Explanation and Elaboration (E&E) document [24].…”

Section: Cent Diagramsmentioning

confidence: 99%

“…CONSORT 2010 checklist items with modifications or additions for individual or series of N-of-1 trials; empty items in the CENT 2015 column indicate no modification from the CONSORT 2010 item.a It is strongly recommended that this checklist be read in conjunction with the CENT 2015 Explanation and Elaboration[24] for important clarification on the items. The copyright for CENT (including checklist) is held by the CENT Group and is distributed under a Creative Commons Attribution (CC-BY 4.0) license.…”

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confidence: 99%

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CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement

Vohra

Shamseer

Sampson

et al. 2016

Journal of Clinical Epidemiology

108

149

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N-of-1 trials provide a mechanism for making evidence-based treatment decisions for an individual patient. They use key methodological elements of group clinical trials to evaluate treatment effectiveness in a single patient, for situations that cannot always accommodate large-scale trials: rare diseases, comorbid conditions, or in patients using concurrent therapies. Improvement in the reporting and clarity of methods and findings in N-of-1 trials is essential for reader to gauge the validity of trials and to replicate successful findings. A Consolidated Standards of Reporting Trials (CONSORT) extension for N-of-1 trials (CENT 2015) provides guidance on the reporting of individual and series of N-of-1 trials. CENT provides additional guidance for 14 of the 25 items of the CONSORT 2010 checklist, recommends a diagram for depicting an individual N-of-1 trial, and modifies the CONSORT flow diagram to address the flow of a series of N-of-1 trials. The rationale, development process, and CENT 2015 checklist and diagrams are reported in this document.

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Magnitude of the Placebo Response Across Treatment Modalities Used for Treatment-Resistant Depression in Adults

et al. 2021

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IMPORTANCEThe placebo effect in depression clinical trials is a substantial factor associated with failure to establish efficacy of novel and repurposed treatments. However, the magnitude of the placebo effect and whether it differs across treatment modalities in treatment-resistant depression (TRD) is unclear.OBJECTIVE To examine the magnitude of the placebo effect in patients with TRD across different treatment modalities and its possible moderators. DATA SOURCESSearches were conducted on MEDLINE, Web of Science, and PsychInfo from inception to June 21, 2021. STUDY SELECTION Randomized clinical trials (RCTs) were included if they recruited patients with TRD and randomized them to a placebo or sham arm and a pharmacotherapy, brain stimulation, or psychotherapy arm. DATA EXTRACTION AND SYNTHESIS Independent reviewers used standard forms for data extraction and quality assessment. Random-effects analyses and standard pairwise meta-analyses were performed. MAIN OUTCOMES AND MEASURES The primary outcome was the Hedges g value for the reported depression scales. Secondary outcomes included moderators assessed via meta-regression and response and remission rates. Heterogeneity was assessed with the I 2 test, and publication bias was evaluated using the Egger test and a funnel plot. Cochrane Risk of Bias Tool was used to estimate risks. RESULTS Fifty RCTs were included involving various types of placebo or sham interventions with a total of 3228 participants (mean [SD] age, 45.8 [6.0] years; 1769 [54.8%] female). The pooledplacebo effect size for all modalities was large (g = 1.05; 95% CI, 0.91-1.1); the placebo effect size in RCTs of specific treatment modalities did not significantly differ. Similarly, response and remission rates associated with placebo were comparable across modalities. Heterogeneity was large. Three variables were associated with a larger placebo effect size: open-label prospective treatment before double-blind placebo randomization (β = 0.35; 95% CI, 0.11 to 0.59; P = .004), later year of publication (β = 0.03; 95% CI, 0.003 to 0.05; P = .03), and industry-sponsored trials (β = 0.34; 95% CI, 0.09 to 0.58; P = .007). The number of failed interventions was associated with the probability a smaller placebo effect size (β = −0.12; 95% CI, −0.23 to −0.01, P = .03). The Egger test result was not significant for small studies' effects. (continued) Key Points Question What is the placebo effect magnitude in different treatment modalities used for management of patients with treatment-resistant depression? Findings In this systematic review and meta-analysis of 3228 patients with treatment-resistant depression in 50 randomized clinical trials, the placebo effect size was large and consistent across treatment modalities. Response and remission rates associated with placebo effect were comparable across modalities.Meaning The findings of this study suggest a placebo effect size benchmark may be used to interpret the findings of past and future clinical trials.

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CONSORT extension for reporting N-of-1 trials (CENT) 2015: Explanation and elaboration

Cited by 144 publications

References 46 publications

CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement

CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement

CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement

Magnitude of the Placebo Response Across Treatment Modalities Used for Treatment-Resistant Depression in Adults

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