Statistical Significance and Clinical Relevance

Bhardwaj, Sachin S.; Camacho, Fabian; Derrow, Amy; Fleischer, Alan B.; Feldman, Steven R.

doi:10.1001/archderm.140.12.1520

Cited by 68 publications

(21 citation statements)

References 15 publications

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“…However, the purpose of preclinical exploratory trials is to provide preliminary evidence on the clinical efficacy of an intervention [16,36]. When evaluating the validity of a study, it is important to consider both the clinical and statistical significance of the findings [53]. Studies that claim clinical relevance may lack sufficient statistical significance to make meaningful statements or, conversely, may lack practicality despite showing a statistically significant difference in treatment options.…”

Section: Discussionmentioning

confidence: 99%

“…Studies that claim clinical relevance may lack sufficient statistical significance to make meaningful statements or, conversely, may lack practicality despite showing a statistically significant difference in treatment options. Researchers and clinicians should not focus on small P values alone to decide whether a treatment is clinically useful; it is necessary to also consider the magnitude(s) of treatment differences and the power of the study [53]. Encouraging in this context is the observation that most of the between-groups comparisons for adherence show medium or medium-to-high magnitude(s) of treatment differences in favor of the tablet groups.…”

Section: Discussionmentioning

confidence: 99%

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Tablet-Based Strength-Balance Training to Motivate and Improve Adherence to Exercise in Independently Living Older People: A Phase II Preclinical Exploratory Trial

Silveira¹,

Langenberg²,

Reve³

et al. 2013

J Med Internet Res

134

155

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BackgroundReaction time, coordination, and cognition performance typically diminish in older adults, which may lead to gait impairments, falls, and injuries. Regular strength–balance exercises are highly recommended to reduce this problem and to improve health, well-being, and independence in old age. However, many older people face a lack of motivation in addition to other strong barriers to exercise. We developed ActiveLifestyle, an information technology (IT)-based system for active and healthy aging aiming at improving balance and strength. ActiveLifestyle is a training app that runs on a tablet and assists, monitors, and motivates older people to follow personalized training plans autonomously at home.ObjectiveThe objectives were to (1) investigate which IT-mediated motivation strategies increase adherence to physical exercise training plans in older people, (2) assess the impact of ActiveLifestyle on physical activity behavior change, and (3) demonstrate the effectiveness of the ActiveLifestyle training to improve gait speed.MethodsA total of 44 older adults followed personalized, 12-week strength and balance training plans. All participants performed the exercises autonomously at home. Questionnaires were used to assess the technological familiarity and stage of behavior change, as well as the effectiveness of the motivation instruments adopted by ActiveLifestyle. Adherence to the exercise plan was evaluated using performance data collected by the app and through information given by the participants during the study. Pretests and posttests were performed to evaluate gait speed of the participants before and after the study.ResultsParticipants were 75 years (SD 6), predominantly female (64%), held a trade or professional diploma (54%), and their past profession was in a sitting position (43%). Of the 44 participants who enrolled, 33 (75%) completed the study. The app proved to assist and motivate independently living and healthy older adults to autonomously perform strength–balance exercises (median 6 on a 7-point Likert scale). Social motivation strategies proved more effective than individual strategies to stimulate the participants to comply with the training plan, as well as to change their behavior permanently toward a more physically active lifestyle. The exercises were effective to improve preferred and fast gait speed.ConclusionsActiveLifestyle assisted and motivated independently living and healthy older people to autonomously perform strength–balance exercises over 12 weeks and had low dropout rates. The social motivation strategies were more effective to stimulate the participants to comply with the training plan and remain on the intervention. The adoption of assistive technology devices for physical intervention tends to motivate and retain older people exercising for longer periods of time.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Tablet-Based Strength-Balance Training to Motivate and Improve Adherence to Exercise in Independently Living Older People: A Phase II Preclinical Exploratory Trial

Silveira¹,

Langenberg²,

Reve³

et al. 2013

J Med Internet Res

134

155

View full text Add to dashboard Cite

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“…Clinical significance—a meaningful change in the symptomatic state or functioning of an individual patient—requires independent replication of results [19]. Different fields have different criteria for clinical significance.…”

Section: Statistical Significance Versus Clinical Significancementioning

confidence: 99%

Perspectives on the Efficacy of Antidepressants for Child and Adolescent Depression

Raz

2005

PLoS Med

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“…Berk and Freedman (2003) have made a strong case that the assumptions of random and independent sampling from a population are rarely true. The problems are particularly salient in the clinical sciences, where the falsity of the assumptions, as well as the divergences between statistical and clinical significance, are particularly obvious and dramatic (Bhardwaj et al, 2004;Ferrill et al, 2010;Fethney, 2010;Page, 2014). However, statistical tests not only test hypotheses but countless assumptions and the entire environment in which research takes place (Amrhein et al, 2018;Greenland, 2017Greenland, , 2018.…”

Section: Questioning the Assumptionsmentioning

confidence: 99%

Manipulating the alpha level cannot cure significance testing

Trafimow

Amrhein

Areshenkoff

et al. 2018

Preprint

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We argue that making accept/reject decisions on scientific hypotheses, including a recent call for changing the canonical alpha level from p= .05 to .005, is deleterious for the finding of new discoveries and the progress of science. Given that blanket and variable alpha levels both are problematic, it is sensible to dispense with significance testing altogether. There are alternatives that address study design and sample size much more directly than significance testing does; but none of the statistical tools should be taken as the new magic method giving clear-cut mechanical answers. Inference should not be based on single studies at all, but on cumulative evidence from multiple independent studies. When evaluating the strength of the evidence, we should consider, for example, auxiliary assumptions, the strength of the experimental design, and implications for applications. To boil all this down to a binary decision based on a p-value threshold of .05, .01, .005, or anything else, is not acceptable.

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Statistical Significance and Clinical Relevance

Cited by 68 publications

References 15 publications

Tablet-Based Strength-Balance Training to Motivate and Improve Adherence to Exercise in Independently Living Older People: A Phase II Preclinical Exploratory Trial

Tablet-Based Strength-Balance Training to Motivate and Improve Adherence to Exercise in Independently Living Older People: A Phase II Preclinical Exploratory Trial

Perspectives on the Efficacy of Antidepressants for Child and Adolescent Depression

Manipulating the alpha level cannot cure significance testing

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