CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions

BackgroundCochrane recently published a systematic review on motivational interviewing (MI) for alcohol misuse in young adults. The review authors concluded that ‘there are no substantive, meaningful benefits of MI interventions for the prevention of alcohol misuse’ (p. 2), as effect sizes were ‘small and unlikely to be of any meaningful benefit in practice’ (p. 27). As most of these interventions were quite brief, we wish to open a dialogue about interpreting effect sizes in this review and of (brief) alcohol interventions more generally.AnalysisWe analyze four methodological aspects of the review that likely influenced the author's conclusions about intervention effects: (1) risk of bias assessments, (2) search strategies, (3) assessing the quality of the body of evidence and (4) definitions of sustainability and clinical significance.ConclusionsWe interpret the effect sizes found in this review to indicate modest yet beneficial and potentially meaningful effects of these interventions, given their brevity and low cost. This interpretation is consistent with other reviews on brief, MI‐based interventions and brief interventions more generally. We therefore encourage the field to re‐open dialogue about the clinical importance of the effects of MI on alcohol misuse by young adults. Rather than dismissing interventions with small effects, we believe a more fruitful way forward for the field would be to catalogue effect sizes for various alcohol interventions. Such a catalogue would help stakeholders themselves to choose which interventions meet their minimum desired impact, and thus may be suitable given their targeted populations, setting and resources.

There has been a recent surge of eHealth programs in cancer and other content areas, but few reviews have focused on the methodologies and designs employed in these studies. We conducted a systematic review of studies on eHealth interventions on cancer prevention and control published between 2001 and 2010 applying the Pragmatic Explanatory Continuum Indicator Summary (PRECIS) criteria and external validity components from the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. We identified 113 studies that focused on cancer prevention and control of eHealth interventions. Most studies fell midway along the explanatory/ pragmatic trial continuum, but few reported on various practical feasibility criteria for translation. Despite vast interest in cancer eHealth and the applied nature of this field, few studies considered key external validity issues. There is a need for use of alternative pragmatic study designs and transparent reporting of external validity components to produce more rapid and generalizable results.Keywords eHealth, Pragmatic trials, Systematic review, Design, PRECIS, External validity, RE-AIM framework BACKGROUND Reductions in cancer morbidity and mortality are partly attributable to interventions addressing modifiable risk factors and screening behaviors [1]. However, such advancements in cancer outcomes are not observed among all populations, specifically those with limited access to cancer care and efficacious behavior interventions [2,3]. The recent surge of eHealth interventions (EHIs) presents unique opportunities to enhance cancer prevention and control by increasing intervention reach, adapting to various contextual conditions, being readily available where users live, work, and play, and tailoring information to patients' needs [4][5][6].eHealth research is a relatively young field that is rapidly growing. EHIs have been found to be effective in promoting change in behaviors, knowledge, self-

IMPORTANCEExercise therapies are advocated in osteoarthritis (OA) clinical guidelines. However, challenges to accessing exercise may be limiting widespread uptake.OBJECTIVE To evaluate the effects of a self-directed web-based strengthening exercise and physical activity program supported by automated behavior-change text messages on knee pain and function for people with knee OA. DESIGN, SETTING, AND PARTICIPANTSThe participant-blinded and assessor-blinded randomized clinical trial enrolled 206 people who met clinical criteria for knee OA in communities across Australia from July 2018 to August 2019, with follow-up taking place at 24 weeks. INTERVENTIONSThe control group was given access to a custom-built website with information on OA and the importance of exercise and physical activity. The intervention group was given access to the same information plus a prescription for a 24-week self-directed strengthening regimen and guidance to increase physical activity, supported by automated behavior-change text messages encouraging exercise adherence.MAIN OUTCOMES AND MEASURES Primary outcomes were change in overall knee pain (numeric rating scale, 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68) over 24 weeks. Secondary outcomes were another knee pain measure, sport and recreation function, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction. RESULTSOf 206 participants, 180 (87%; mean [SD] age, 60 [8.4] years; 109 [61%] women) completed both 24-week primary outcomes. The intervention group showed greater improvements in overall knee pain (mean difference, 1.6 units; 95% CI, 0.9-2.2 units; P < .001) and physical function (mean difference, 5.2 units; 95% CI, 1.9-8.5 units; P = .002) compared with the control. There was evidence of differences in the proportion of participants exceeding the minimal clinically important improvement in pain (intervention group, 72.1%, vs control, 42.0%; risk difference, 0.30 [95% CI, 0.16-0.44]; P <. 001) and function (intervention group, 68%, vs control, 40.8%; risk difference, 0.27 [95% CI, 0.13-0.41]; P < .001) favoring the intervention. Between-group differences for all secondary outcomes favored the intervention except for physical activity, self-efficacy for function, and self-efficacy for exercise, for which there was no evidence of differences.CONCLUSIONS AND RELEVANCE This randomized clinical trial found that a self-directed web-based strengthening exercise regimen and physical activity guidance supported by automated behavior-change text messages to encourage exercise adherence improved knee pain and function at 24 weeks. This unsupervised, free-to-access digital intervention is an effective option to improve patient access to recommended OA exercise and/or to support clinicians in providing exercise management for people with knee OA at scale across the population.