Statistical testing of baseline differences in sports medicine RCTs: a systematic evaluation

Peterson, Ross L.; Tran, Matthew; Koffel, Jonathan; Stovitz, Steven D.

doi:10.1136/bmjsem-2017-000228

Cited by 15 publications

(9 citation statements)

References 6 publications

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“…It is therefore of no use to statistically test for baseline differences between the treatment and the control group. This testing nonsense has been noticed by other authors as well [ 15 , 16 ].…”

Section: Discussionsupporting

confidence: 79%

Different ways to estimate treatment effects in randomised controlled trials

Twisk

Bosman

Hoekstra

et al. 2018

Contemporary Clinical Trials Communications

359

103

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BackgroundRegarding the analysis of RCT data there is a debate going on whether an adjustment for the baseline value of the outcome variable should be made. When an adjustment is made, there is a lot of misunderstanding regarding the way this should be done. Therefore, the aims of this educational paper are: 1) to explain different methods used to estimate treatment effects in RCTs, 2) to illustrate the different methods with a real life example and 3) to give an advise on how to analyse RCT data.MethodsLongitudinal analysis of covariance, repeated measures analysis in which also the baseline value is used as outcome and the analysis of changes were theoretically explained and applied to an example dataset investigating a systolic blood pressure lowering treatment.ResultsIt was shown that differences at baseline should be taken into account and that regular repeated measures analysis and regular analysis of changes did not adjust for the baseline differences between the groups and therefore lead to biased estimates of the treatment effect. In the real life example, due to the differences at baseline between the treatment and control group, the different methods lead to different estimates of the treatment effect.ConclusionRegarding the analysis of RCT data, it is advised to use longitudinal analysis of covariance or a repeated measures analysis without the treatment variable, but with the interaction between treatment and time in the model.

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Section: Discussionsupporting

confidence: 79%

Different ways to estimate treatment effects in randomised controlled trials

Twisk

Bosman

Hoekstra

et al. 2018

Contemporary Clinical Trials Communications

359

103

View full text Add to dashboard Cite

show abstract

“…Chi-square test and Fisher’s exact test compared the baseline characteristics between the two groups. The assessment of interaction effects among baseline parameters was carried out by mixed factorial design ANOVA ( Peterson et al, 2017 ). For within-group analysis, paired t -test was used to study the difference between pre- to post-intervention for normally distributed data, or Wilcoxon signed-rank tests for continuous variables without normal distribution.…”

Section: Methodsmentioning

confidence: 99%

Effect of an 8-Week Yoga-Based Lifestyle Intervention on Psycho-Neuro-Immune Axis, Disease Activity, and Perceived Quality of Life in Rheumatoid Arthritis Patients: A Randomized Controlled Trial

Kumar

Dada

2020

Front. Psychol.

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Various external stressors and environmental challenges lead to the provocation of the immune system in autoimmune diseases like Rheumatoid arthritis (RA). The inappropriate immune response further triggers the cascade of inflammatory changes resulting in precipitation of symptoms and hampers quality of life (QOL). The underlying psycho-somatic component of the disease requires a holistic approach to its treatment dimension rather than the use of pharmacotherapy. The applicability of mind-body interventions has become essential in today’s fast-paced life. Yoga, a mind-body technique, alters the mind’s capacity to facilitate systemic functioning at multiple organ system levels. Hence, we conducted this study to evaluate the impact of 8 weeks of a yoga-based lifestyle intervention (YBLI) on psycho-neuro-immune markers, gene expression patterns, and QOL in RA patients on routine medical therapy. A total of 66 patients were randomized into two groups: yoga group or non-yoga group and were assessed for a panel of inflammatory cytokines (IL-6, IL-17A, TNF-α, and TGF-β), mind-body communicative markers (BDNF, DHEAS, β-endorphin, and sirtuin) and transcript levels of various genes ( IL-6, TNF-α, NFKB1, TGF -β, and CTLA4 ). We assessed disease activity and QOL using the DAS28-ESR and WHOQOL-BREF questionnaire, respectively. Yoga group observed significant improvements in the levels of markers, which influenced the psycho-neuro-immune axis ( p < 0.001) with an estimated effect size from small to medium range. In the yoga group, there was a significant reduction in DAS28-ESR ( p < 0.001) and improvement seen in the physical health, psychological, social relationships domains ( p < 0.001) of QOL, except environmental ( p > 0.05). The yoga group showed downregulation of IL-6, TNF -α, and CTLA4 and upregulation of TGF -β. These results suggest that a decrease in disease activity after yoga practice is associated with a significant reduction in inflammatory cytokines, the elevation of mind-body communicative markers, and normalization of various transcript levels, which improved QOL. Thus the adoption of YBLI improves clinical outcome in RA, and decreases systemic inflammation by its beneficial effects on psycho-neuro-immune axis and normalization of dysregulated transcripts. Thus YBLI may be used for RA patients as an adjunctive therapy.

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“…Regression estimates will be adjusted for participant differences in the number of observations contributing to the mixed models and for variances within subjects [46]. Although gender and age were balanced at baseline, the interaction effects of these variables and treatment should not be omitted [47]. Therefore, fixed effects of the linear mixed models will include testing for time (T1-T4) and treatment (IG-1, IG-2, IG-3 and PCG) effects, adjusted for baseline values, age, gender, and PE class type.…”

Section: Methodsmentioning

confidence: 99%

A web-based lifestyle intervention program for Chinese college students: study protocol and baseline characteristics of a randomized placebo-controlled trial

et al. 2019

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Background This study aimed to describe the design and present the baseline characteristics of a web-based lifestyle intervention program, which comprises of sequentially and simultaneously delivered intervention modules targeting physical activity (PA) and fruit and vegetable consumption (FVC) in Chinese college students. Methods The study adopted a randomized placebo-controlled trial, using the Health Action Process Approach (HAPA) and the Compensatory Carry-Over Action Model (CCAM) as the theoretical backdrops. 556 Chinese college students participated in the 8-week web-based lifestyle intervention program. All eligible participants were randomly assigned to one of four groups: 1) the PA-first arm which received a 4-week intervention addressing PA followed by a 4-week intervention addressing FVC; 2) the FVC-first arm which received a 4-week intervention addressing FVC followed by a 4-week intervention addressing PA; 3) the PA + FVC simultaneous arm that received an 8-week intervention addressing both PA and FVC at the same time; and 4) the placebo-control arm that received 8 weeks of general health information, which is not relevant for changing actual PA and FVC behaviors. Data collection includes four time-points: at the beginning and end of the intervention, and a 3-month and 12-month follow-up after the intervention. Results At baseline, 41.7% of participants were male and 58.3% were female. 41.0% of the participants did not meet the standard PA-recommendations, while 69.6% did not adhere to the standard FVC-recommendations. In total, only 19.6% of participants met both PA and FVC recommendations. Baseline characteristics across the four groups had no significant differences (all P = .17–.99), indicating successful randomization. Conclusions The preliminary results indicate a high prevalence of unhealthy lifestyles in college students in China, which further supports the need for web-based health intervention programs. This is also the first study that examines the comparative effectiveness of simultaneously and sequentially delivered lifestyle interventions in the Chinese population. These findings may contribute to the creation of future web-based health behavior change interventions. Trial registration ClinicalTrails.gov: NCT03627949 , 14 August, 2018. Electronic supplementary material The online version of this article (10.1186/s12889-019-7438-1) contains supplementary material, which is available to authorized users.

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Statistical testing of baseline differences in sports medicine RCTs: a systematic evaluation

Cited by 15 publications

References 6 publications

Different ways to estimate treatment effects in randomised controlled trials

Different ways to estimate treatment effects in randomised controlled trials

Effect of an 8-Week Yoga-Based Lifestyle Intervention on Psycho-Neuro-Immune Axis, Disease Activity, and Perceived Quality of Life in Rheumatoid Arthritis Patients: A Randomized Controlled Trial

A web-based lifestyle intervention program for Chinese college students: study protocol and baseline characteristics of a randomized placebo-controlled trial

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