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

Altman, Douglas G.; Bukutu, Cecilia; Clark, Jocalyn; Cogo, Elise; Gabler, Nicole B.; Guyatt, Gordon; Kravitz, Richard L.; Janosky, Janine E.; Johnston, Bradley C.; Li, Bob T.; Mahon, Jeff; Marles, Robin J.; Moher, David; Nikles, Jane; Sampson, Margaret; Schmid, Christopher H.; Shadish, William R.; Shamseer, Larissa; Tate, Robyn; Vohra, Sunita; Zucker, Deborah

doi:10.1016/j.jclinepi.2015.05.018

Cited by 92 publications

(72 citation statements)

References 98 publications

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“…25 This is why adherence to CONSORT Statement is of ultimate importance so that readers can appraise the available literature and translate this literature into clinical knowledge pertinent to evidence-based practice.…”

Section: Discussionmentioning

confidence: 99%

“…With these calculations, we took into consideration a standard deviation of 3.3 in the DE. The equivalence limit we chose was lower than the DE threshold of 3.0, above which color differences become clinically perceptible (24)(25)(26). "60 Randomisation Sequence generation, allocation concealment and implementation Example 1: "The randomization process was performed by coin toss immediately before the bleaching procedure to provide adequate allocation concealment.…”

Section: Sample Sizementioning

confidence: 99%

“…More attention to these items during the peerreview process may be required. Apart from that, the ambiguous language of what was meant by CONSORT endorsement 25,41,42 in journals may prevent a better CONSORT adherence. In fact, instructions on how CONSORT should be used by authors are inconsistent across journals and publishers.…”

Section: Hypothesis Testingmentioning

confidence: 99%

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Randomized clinical trials of dental bleaching – Compliance with the CONSORT Statement: a systematic review

et al. 2017

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We reviewed the literature to evaluate: a) The compliance of randomized clinical trials (RCTs) on bleaching with the CONSORT; and b) the risk of bias of these studies using the Cochrane Collaboration risk of bias tool (CCRT). We searched the Cochrane Library, PubMed and other electronic databases, to find RCTs focused on bleaching (or whitening). The articles were evaluated in compliance with CONSORT in a scale: 0 = no description, 1 = poor description and 2 = adequate description. Descriptive analyses of the number of studies by journal, follow-up period, country and quality assessments were performed with CCRT for assessing risk of bias in RCTs. 185 RCTs were included for assessment. More than 30% of the studies received score 0 or 1. Protocol, flow chart, allocation concealment and sample size were more critical items, as 80% of the studies scored 0. The overall CONSORT score for the included studies was 16.7 ± 5.4 points, which represents 52.2% of the maximum CONSORT score. A significant difference among journal, country and period of time was observed (p < 0.02). Only 7.6% of the studies were judged at "low" risk; 62.1% were classified as "unclear"; and 30.3% as "high" risk of bias. The adherence of RCTs evaluating bleaching materials and techniques to the CONSORT is still low with unclear/high risk of bias.

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Section: Discussionmentioning

confidence: 99%

Section: Sample Sizementioning

confidence: 99%

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Randomized clinical trials of dental bleaching – Compliance with the CONSORT Statement: a systematic review

et al. 2017

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“…SCEs are also gaining in popularity in medical science (where they are often called N-of-1 designs) to evaluate treatments for patients with for instance chronic pain or attention deficit hyperactivity disorder (Gabler, Duan, Vohra & Kravits, 2011). The recent development of guidelines for reporting the results of SCEs confirm the growing interest towards these types of designs in the educational, behavioral, and health sciences (Shamseer et al, 2015;Tate, Togher, Perdices, McDonald & Rosenkoetter, 2012).…”

Section: Introductionmentioning

confidence: 93%

The conditional power of randomization tests for single-case effect sizes in designs with randomized treatment order: A Monte Carlo simulation study

2017

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The conditional power (CP) of the randomization test (RT) was investigated in a simulation study in which three different single-case effect size (ES) measures were used as the test statistic: the mean difference (MD), the Percentage of Nonoverlapping Data (PND), and the Nonoverlap of All Pairs (NAP). Furthermore, we studied the effect of the experimental design on the RT's CP for three different single-case designs with rapid treatment alternation: the completely randomized design (CRD), the randomized block design (RBD), and the restricted randomized alternation design (RRAD). As a third goal, we evaluated the CP of the RT for three types of simulated data: data generated from a standard normal distribution, data generated from a uniform distribution, and data generated from a first-order autoregressive Gaussian process. The results showed that the MD and NAP perform very similar in terms of CP whereas the PND performs substantially worse. Furthermore, the RRAD yielded marginally higher power in the RT, followed by the CRD and then the RBD. Finally, the power of the RT was almost unaffected by the type of simulated data. Based on the results of the simulation study, we recommend at least 20 measurement occasions for single-case designs with randomized treatment order that are to be evaluated with an RT using a 5% significance level. Furthermore, we do not recommend the use of the PND because of its low power in the RT.

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“…Time series analysis produces vast amounts of data and there is no established consensus on how to best analyse n-of-1 studies (Shamseer et al, 2015). Researchers reporting n-of-1 outcomes often treat each of the participants as a separate study.…”

Section: Unanswered Questions and Future Researchmentioning

confidence: 99%

N-of-1 study of weight loss maintenance assessing predictors of physical activity, adherence to weight loss plan and weight change

Kwaśnicka

Dombrowski

White

et al. 2017

Psychology & Health

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Objective: Behaviour change interventions are effective in supporting individuals to achieve clinically significant weight loss, but weight loss maintenance (WLM) is less often attained. This study examined predictive variables associated with WLM. Design: N-of-1 study with daily ecological momentary assessment combined with objective measurement of weight and physical activity, collected with wireless devices (Fitbit™) for six months. Eight previously obese adults who had lost over 5% of their body weight in the past year took part. Data were analysed using time series methods. Main outcomes measures: Predictor variables were based on five theoretical themes: maintenance motives, self-regulation, personal resources, habits, and environmental influences. Dependent variables were: objectively estimated step count and weight, and self-reported WLM plan adherence. Results: For all participants, daily fluctuations in self-reported adherence to their WLM plan were significantly associated with most of the explanatory variables, including maintenance motivation and satisfaction with outcomes, self-regulation, habit, and stable environment. Personal resources were not a consistent predictor of plan adherence. Conclusion: This is the first study to assess theoretical predictions of WLM within individuals. WLM is a dynamic process including the interplay of motivation, self-regulation, habit, resources, and perceptions of environmental context. Individuals maintaining their weight have unique psychological profiles which could be accounted for in interventions.Keywords: behaviour change maintenance; n-of-1 study; theory; weight loss maintenance *Corresponding author. Email: dominika.kwasnicka@curtin.edu.au © 2017 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecom mons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Psychology & Health, 2017 Vol. 32, No. 6, 686-708, http://dx.doi.org/10.1080/08870446.2017 Introduction Weight loss maintenance (WLM) has been defined as a process of sustaining a significant intentional weight loss accomplished by one's own efforts and/or as a result of treatment (Elfhag & Rossner, 2005). The specific criteria used to define WLM vary between research studies. Discrepancies include the percentage of weight loss required and the length of time for maintained weight loss. For instance in terms of percentage weight loss, WLM researchers suggest that a minimum of 3% (Stevens, Truesdale, McClain, & Cai, 2005), 5% (Crawford, Jeffery, & French, 2000) or 10% (Wing & Hill, 2001) is necessary to be classified as successful WLM. The time period requirements for substantial WLM also differ; for example, a minimum of 6 months (Elfhag & Rossner, 2005), 12 months (Wing & Hill, 2001) or 24 months (Stevens et al., 2005) of maintained weight loss have been sugg...

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

Cited by 92 publications

References 98 publications

Randomized clinical trials of dental bleaching – Compliance with the CONSORT Statement: a systematic review

Randomized clinical trials of dental bleaching – Compliance with the CONSORT Statement: a systematic review

The conditional power of randomization tests for single-case effect sizes in designs with randomized treatment order: A Monte Carlo simulation study

N-of-1 study of weight loss maintenance assessing predictors of physical activity, adherence to weight loss plan and weight change

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