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

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

doi:10.1016/j.jclinepi.2015.05.004

Cited by 107 publications

(150 citation statements)

References 25 publications

(18 reference statements)

Supporting

Mentioning

149

Contrasting

Unclassified

Order By: Relevance

“…Currently, there are no quality assessment tools for the appraisal of N of 1 trials in clinical medicine. A modified version of the CONSORT extension for reporting N of 1 Trials (CENT) [5] will be used to appraise the quantitative papers. This will be in a yes/ no format to determine if the studies reported items in the checklist.…”

Section: Quality Assessmentmentioning

confidence: 99%

“…In clinical medicine, the term N of 1 trial has been used to describe trials with multiple crossover and a repeat challenge-withdrawal design; for example, the ABAB design sequence in which a single patient receives an intervention during some periods (A) and then receives the control or alternate intervention or no intervention during the other periods (B) [4,5]. In N of 1 trials in clinical medicine, individuals are studied during at least four periods-that is both the A and B phase are repeated at least once.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

N of 1 trials and the optimal individualisation of drug treatments: a systematic review protocol

et al. 2017

View full text Add to dashboard Cite

Background: Guidelines and evidence-based drug treatment recommendations are usually based on the results of clinical trials, which have limited generalisability in routine clinical settings due to their restrictive eligibility criteria. These trials are also conducted in ideal and rigorously controlled settings. N of 1 trials, which are single patient multiple crossover studies, offer a means of increasing the evidence base and individualising care for individuals in clinical practice. This systematic review of the N of 1 drug treatment trial aims to investigate its usefulness for achieving optimal individualised patient care. Methods:The following databases will be searched for relevant articles: MEDLINE, EMBASE, PsycINFO (all via Ovid), AMED, CINAHAL (via EBSCO), The Cochrane Library (including CENTRAL, NHS EED, and DARE), and Web of Science (Thomson Reuters). Supplementary searches will include ongoing trial databases and organisational websites. All N of 1 trials in which patients have been treated with a drug will be considered. Outcomes will include information on the clinical usefulness of N of 1 trials-i.e. achievement of optimal individualised care, health-care utilisation of patients, frequently used practices, experiences of clinical care or participation in N of 1 trials, adherence to treatment plan, and unwanted effects of the treatment. Screening of included papers will be undertaken independently by two reviewers, while data extraction and the quality of reporting will be conducted by one reviewer and checked by another. Both quantitative and qualitative summaries will be reported using appropriate methods. Discussion: This review will provide new insights into the clinical utility of N of 1 drug trials in helping participants find the most acceptable treatment as defined by patients and clinicians based on the selected outcome measures and the perspectives of participants involved in such trials. Findings from this review will inform the development of a stakeholder workshop and guidance to help physicians find the optimum therapy for their patients and will help guide future research on N of 1 trials. Systematic review registration: PROSPERO CRD42016032452

show abstract

Section: Quality Assessmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

N of 1 trials and the optimal individualisation of drug treatments: a systematic review protocol

et al. 2017

View full text Add to dashboard Cite

show abstract

“…Many such guidelines exist and the CONSORT Extension to Nonpharmacological Trials (Boutron et al, 2008) provides suitable guidance for reporting between-groups intervention studies in the behavioral sciences. The CONSORT Extension for N-of-1 Trials (CENT 2015) was developed for multiple crossover trials with single individuals in the medical sciences Vohra et al, 2015), but there is no reporting guideline in the CONSORT tradition for single-case research used in the behavioral sciences. We developed the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016 to meet this need.…”

Section: Scientific Abstractmentioning

confidence: 99%

“…The analogous reporting guide for the medical sciences, CONSORT Extension for N-of-1 Trials (CENT 2015;Shamseer et al, 2015;Vohra et al, 2015), is available for the reporting of medical N-of-1 trials. These trials consist of multiple cross-overs (described as challenge-withdrawal-challenge-withdrawal in Vohra et al) in a single participant who serves as his or her own control, often incorporating randomization and blinding.…”

Section: Scientific Abstractmentioning

confidence: 99%

The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement

Tate

Perdices

Rosenkoetter

et al. 2016

Remedial and Special Education

Self Cite

View full text Add to dashboard Cite

We developed a reporting guideline to provide authors with guidance about what should be reported when writing a paper for publication in a scientific journal using a particular type of research design: the single-case experimental design. This report describes the methods used to develop the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016. As a result of 2 online surveys and a 2-day meeting of experts, the SCRIBE 2016 checklist was developed, which is a set of 26 items that authors need to address when writing about single-case research. This article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated. We recommend that the SCRIBE 2016 is used by authors preparing manuscripts describing single-case research for publication, as well as journal reviewers and editors who are evaluating such manuscripts.

show abstract

“…For this reason, CONSORT statement was first developed to improve RCT reporting in 1996 (Begg et al 1996) and then updated in 2001 (Altman et al 2001(Moher et al 2010. Recently, the CONSORT extension for reporting N-of-1 trials (CENT) 2015 statement was also developed (Vohra et al 2015). Full reporting of an RCT contains many sections.…”

Section: Introductionmentioning

confidence: 99%

Reporting quality of randomized and non-randomized controlled trial abstracts from chicken research

Sukon

Kongpechr

Bubpahou

et al. 2016

Preprint

View full text Add to dashboard Cite

In publication of a controlled trial article from health science research, the abstract is an important part that readers usually read first and then decide whether to read the whole article; therefore, information provided in the abstract should be adequate. The CONSORT (consolidated standards of reporting trials) for Abstracts checklist has been developed and used as a guideline for authors to prepare their manuscripts. This checklist has also been used as a tool to evaluate published abstracts. The objectives of this study were to evaluate reporting quality of randomized controlled trial (RCT) and non-RCT abstracts from chicken research and to determine factors associated with the reporting quality. We searched PubMed for RCT and non-RCT abstracts involving chicken research published between 2006 and 2015. The included abstracts were evaluated using the modified CONSORT for Abstracts checklist. The primary outcome was a mean overall quality score (OQS), which, for each abstract, was a sum of items reported in the modified CONSORT for Abstracts checklist. In addition, some pre-specified factors were evaluated for their association with the reporting quality using simple and multiple linear regression analyses.A total of 949 abstracts (n=262 for RCT and n=687 for non-RCT abstracts) were included and evaluated. Although OQS was significantly greater in RCT than in non-RCT abstracts (mean ± SD, 6.7 ± 0.9 vs 3.3 ± 1.1; P-value<0.001), both mean scores were still less than half of the full score of 15. Only 2 items-objective and conclusions-were adequately reported (>80%) in both types of the abstracts. Items concerning trial design, participants, interventions, randomization, and number randomized were adequately reported only in the RCT abstracts. In contrast, items concerning the study as randomized in the title, clearly defined primary outcome, blinding, numbers analyzed, estimated effect size and its precision for the primary outcome, trial registration, and funding were not reported or reported less than 5% in both RCT and non-RCT abstracts. In this study, 4 factors-year of publication, number of trials reported, number of experimental groups reported, and sample size reported-were associated with OQS. That is, abstracts with higher OQS were published more recently, reported a single trial rather than multiple trials, reported number of experimental groups rather than not reported, and reported sample size rather than not reported. These factors explained about 37.5% of the variance of OQS. In AbstractIn publication of a controlled trial article from health science research, the abstract is an important part that readers usually read first and then decide whether to read the whole article; therefore, information provided in the abstract should be adequate. The CONSORT (consolidated standards of reporting trials) for Abstracts checklist has been developed and used as a guideline for authors to prepare their manuscripts. This checklist has also been used as a tool to evaluate published abstracts. The objective...

show abstract

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

Cited by 107 publications

References 25 publications

N of 1 trials and the optimal individualisation of drug treatments: a systematic review protocol

N of 1 trials and the optimal individualisation of drug treatments: a systematic review protocol

The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement

Reporting quality of randomized and non-randomized controlled trial abstracts from chicken research

Contact Info

Product

Resources

About