The MIPAM trial: a 12-week intervention with motivational interviewing and physical activity monitoring to enhance the daily amount of physical activity in community-dwelling older adults - a study protocol for a randomized controlled trial.

BACKGROUND: Physical Activity Monitors (PAMs) have been shown to effectively enhance level of physical activity (PA) in older adults. Motivational interviewing is a person-centred model where participants are guided using self-reflection and counselling, and addresses the behavioural and psychological aspects of why people initiate health behaviour change by prompting increases in motivation and self-efficacy. The addition of motivational interviewing to PA interventions may increase the effectiveness of PAMs for older adults. METHODS: This motivational interviewing and PA monitoring trial is designed as an investigator-blinded, two arm parallel group, randomized controlled superiority trial with primary endpoint after 12 weeks of intervention. The intervention group will receive a PAM-based intervention and motivational interviewing and the control group will only receive the PAM-based intervention. The primary outcome is PA, objectively measured as the average daily number of steps throughout the intervention period. Secondary outcome measures include self-reported PA health-related quality of life, loneliness, self-efficacy for exercise, outcome expectancy for exercise, and social relations. The outcomes will be analysed with a linear regression model investigating between-group differences, adjusted for baseline scores. Following the intention to treat principle, multiple imputation will be performed to handle missing values. DISCUSSION: A moderate effect of daily PA measured using PAMs is expected in this superiority RCT investigating the effect of adding motivational interviewing to a PAM intervention. According to the World Health Organization, walking and cycling are key activities in regular PA and should be promoted. To increase the general public health and lower the burden of inactivity in older adults, cost-beneficial solutions should be investigated further. If this RCT shows that motivational interviewing can enhance the effect of PAM-based interventions, it might be included as an add-on intervention when appropriate. No matter what the results of this study will be, the conclusions will be relevant for clinicians as the dependence on technology is increasing, especially in relation to public health promotion. TRIAL REGISTRATION: NCT03906162 , April 1, 2019.

Usefulness of Cochrane Reviews in Clinical Guideline Development-A Survey of 585 Recommendations.

The Danish Health Authority develops clinical practice guidelines to support clinical decision-making based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system and prioritizes using Cochrane reviews. The objective of this study was to explore the usefulness of Cochrane reviews as a source of evidence in the development of clinical recommendations. Evidence-based recommendations in guidelines published by the Danish Health Authority between 2014 and 2021 were reviewed. For each recommendation, it was noted if and how Cochrane reviews were utilized. In total, 374 evidence-based recommendations and 211 expert consensus recommendations were published between 2014 and 2021. Of the 374 evidence-based recommendations, 106 included evidence from Cochrane reviews. In 28 recommendations, all critical and important outcomes included evidence from Cochrane reviews. In 36 recommendations, a minimum of all critical outcomes included evidence from Cochrane reviews, but not all important outcomes. In 33 recommendations, some but not all critical outcomes included evidence from Cochrane reviews. Finally, in nine recommendations, some of the important outcomes included evidence from Cochrane reviews. In almost one-third of the evidence-based recommendations, Cochrane reviews were used to inform clinical recommendations. This evaluation should inform future evaluations of Cochrane review uptake in clinical practice guidelines concerning outcomes important for clinical decision-making.

Effectiveness of physical activity monitors in adults: systematic review and meta-analysis.

OBJECTIVE: To estimate the effectiveness of physical activity monitor (PAM) based interventions among adults and explore reasons for the heterogeneity. DESIGN: Systematic review and meta-analysis. STUDY SELECTION: The electronic databases MEDLINE, Embase, SPORTDiscus, CINAHL, and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched on 4 June 2021. Eligible randomised controlled trials compared interventions in which adults received feedback from PAMs with control interventions in which no feedback was provided. No restrictions on type of outcome measurement, publication date, or language were applied. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data and assessed risk of bias. Random effects meta-analyses were used to synthesise the results. The certainty of evidence was rated by the Grading of Recommendations Assessment and Evaluation (GRADE) approach. MAIN OUTCOME MEASURES: The three primary outcomes of interest were physical activity, moderate to vigorous physical activity, and sedentary time. RESULTS: 121 randomised controlled trials with 141 study comparisons, including 16 743 participants, were included. The PAM based interventions showed a moderate effect (standardised mean difference 0.42, 95% confidence interval 0.28 to 0.55) on physical activity, equivalent to 1235 daily steps; a small effect (0.23, 0.16 to 0.30) on moderate to vigorous physical activity, equivalent to 48.5 weekly minutes; and a small insignificant effect (-0.12, -0.25 to 0.01) on sedentary time, equal to 9.9 daily minutes. All outcomes favoured the PAM interventions. CONCLUSIONS: The certainty of evidence was low for the effect of PAM based interventions on physical activity and moderate for moderate to vigorous physical activity and sedentary time. PAM based interventions are safe and effectively increase physical activity and moderate to vigorous physical activity. The effect on physical activity and moderate to vigorous physical activity is well established but might be overestimated owing to publication bias. STUDY REGISTRATION: PROSPERO CRD42018102719.

The MIPAM trial - motivational interviewing and physical activity monitoring to enhance the daily level of physical activity among older adults - a randomized controlled trial.

BACKGROUND: One in four older adults in Denmark and almost half of the very old above 75 do not meet the World Health Organization's recommendations for a minimum of physical activity (PA). A cost-efficient and effective way to increase focus on and motivation for daily walking might be to use Physical Activity Monitors (PAMs) in combination with behavioural change intervention. Thus, the objective of this randomized controlled study was to investigate the effect of Motivational Interviewing (MI) as an add-on intervention to a PAM-based intervention measured in community-dwelling older adults. METHODS: This two-arm parallel group randomized controlled effectiveness trial compared a 12-weeks PAM-based intervention with additional MI (PAM+MI group) with a PAM-based intervention alone (PAM group). The primary outcome, average daily step count, was analysed with a linear regression model, adjusted for sex and baseline daily step count. Following the intention-to-treat principle, multiple imputation based on baseline step count, sex and age was performed. RESULTS: In total, 38 participants were randomized to the PAM intervention and 32 to the PAM+MI intervention arm. During the intervention period, PAM+MI participants walked on average 909 more steps per day than PAM participants, however insignificant (95%CI: - 71; 1889) and reported 2.3 points less on the UCLA Loneliness Scale (95%CI: - 4.5; - 1.24). CONCLUSION: The use of MI, in addition to a PAM-based intervention among older adults in PA promoting interventions hold a potential clinically relevant effect on physical activity and should thus be investigated further with adequately powered RCTs. TRIAL REGISTRATION: This study was pre-registered in the clinicaltrials.gov database with identifier: NCT03906162 .

Parent-Mediated Interventions for Children and Adolescents With Autism Spectrum Disorders: A Systematic Review and Meta-Analysis.

There has been increasing interest in parent-mediated interventions (PMIs) for children with autism spectrum disorders (ASDs). The objective of this systematic review and meta-analysis was to examine the effect of PMIs compared to no PMI for children with ASD aged 2-17 years. The primary outcome was adaptive functioning rated by a parent or clinician. The secondary outcomes were long-term adaptive functioning rated by the parents, adverse events, core symptoms of ASD, disruptive behavior, parental well-being, quality of life of the child rated by the parents and anxiety. The MEDLINE, PsycInfo, Embase, and CINAHL databases were searched in March 2020. The Cochrane Risk of Bias Tool was used to rate the individual studies, and the certainty in the evidence was evaluated using GRADE. We identified 30 relevant randomized controlled trials (RCTs), including 1,934 participants. A clinically relevant effect of PMIs on parent-rated adaptive functioning was found with a low certainty of evidence [Standard mean difference (SMD): 0.28 (95% CI: -0.01, 0.57)] on Vineland Adaptive Behavior Scales (VABS), whereas no clinically relevant effect was seen for clinician-rated functional level, with a very low certainty of evidence [SMD on Clinical Global Impressions (CGI)-severity scale: SMD -0.45 [95% CI: -0.87, -0.03)]. PMIs may slightly improve clinician-rated autism core symptoms [SMD: -0.35 (95% CI: -0.71, 0.02)]. Additionally, no effect of PMIs on parent-rated core symptoms of ASD, parental well-being or adverse effects was identified, all with a low certainty of evidence. There was a moderate certainty of evidence for a clinically relevant effect on disruptive behavior [SMD: 0.55 (95% Cl: 0.36, 0.74)]. The certainty in the evidence was downgraded due to serious risk of bias, lack of blinding, and serious risk of imprecision due to few participants included in meta-analyses. The present findings suggest that clinicians may consider introducing PMIs to children with ASD, but more high-quality RCTs are needed because the effects are not well-established, and the results are likely to change with future studies. The protocol for the systematic review is registered at the Danish Health Authority website (www.sst.dk).