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There is mixed evidence to support current ambitions for mobile health (mHealth) apps to improve chronic health and well-being. One proposed explanation for this variable effect is that users do not engage with apps as intended. The application of analytics, defined as the use of data to generate new insights, is an emerging approach to study and interpret engagement with mHealth interventions. This study aimed to consolidate how analytic indicators of engagement have previously been applied across clinical and technological contexts, to inform how they might be optimally applied in future evaluations. We conducted a scoping review to catalog the range of analytic indicators being used in evaluations of consumer mHealth apps for chronic conditions. We categorized studies according to app structure and application of engagement data and calculated descriptive data for each category. Chi-square and Fisher exact tests of independence were applied to calculate differences between coded variables. A total of 41 studies met our inclusion criteria. The average mHealth evaluation included for review was a two-group pretest-posttest randomized controlled trial of a hybrid-structured app for mental health self-management, had 103 participants, lasted 5 months, did not provide access to health care provider services, measured 3 analytic indicators of engagement, segmented users based on engagement data, applied engagement data for descriptive analyses, and did not report on attrition. Across the reviewed studies, engagement was measured using the following 7 analytic indicators: the number of measures recorded (76%, 31/41), the frequency of interactions logged (73%, 30/41), the number of features accessed (49%, 20/41), the number of log-ins or sessions logged (46%, 19/41), the number of modules or lessons started or completed (29%, 12/41), time spent engaging with the app (27%, 11/41), and the number or content of pages accessed (17%, 7/41). Engagement with unstructured apps was mostly measured by the number of features accessed (8/10, P=.04), and engagement with hybrid apps was mostly measured by the number of measures recorded (21/24, P=.03). A total of 24 studies presented, described, or summarized the data generated from applying analytic indicators to measure engagement. The remaining 17 studies used or planned to use these data to infer a relationship between engagement patterns and intended outcomes. Although researchers measured on average 3 indicators in a single study, the majority reported findings descriptively and did not further investigate how engagement with an app contributed to its impact on health and well-being. Researchers are gaining nuanced insights into engagement but are not yet characterizing effective engagement for improved outcomes. Raising the standard of mHealth app efficacy through measuring analytic indicators of engagement may enable greater confidence in the causal impact of apps on improved chronic health and well-being.

We sought to estimate the prevalence, severity and identify predictors of violence among adolescent girls and young women (AGYW) in informal settlement areas of Nairobi, Kenya, selected for DREAMS (Determined Resilient Empowered AIDS-free, Mentored and Safe) investment. Data were collected from 1687 AGYW aged 10-14 years (n = 606) and 15-22 years (n = 1081), randomly selected from a general population census in Korogocho and Viwandani in 2017, as part of an impact evaluation of the \"DREAMS\" Partnership. For 10-14 year-olds, we measured violence experienced either in the past 6 months or ever using a different set of questions from those used for 15-22 year-olds. Among 15-22 year-olds we measured prevalence of violence, experienced in the past 12 months, using World Health Organization (WHO) definitions for violence typologies. Predictors of violence were identified using multivariable logit models. Among 606 girls aged 10-14 years, about 54% and 7% ever experienced psychological and sexual violence, respectively. About 33%, 16% and 5% experienced psychological, physical and sexual violence in the past 6 months. The 10-14 year old girls who engaged in chores or activities for payment in the past 6 months, or whose family did not have enough food due to lack of money were at a greater risk for violence. Invitation to DREAMS and being a non-Christian were protective. Among 1081 AGYW aged 15-22 years, psychological violence was the most prevalent in the past year (33.1%), followed by physical violence (22.9%), and sexual violence (15.8%). About 7% experienced all three types of violence. Severe physical violence was more prevalent (13.8%) than moderate physical violence (9.2%). Among AGYW aged 15-22 years, being previously married/lived with partner, engaging in employment last month, food insecure were all risk factors for psychological violence. For physical violence, living in Viwandani and being a Muslim were protective; while being previously married or lived with a partner, or sleeping hungry at night during the past 4 weeks were risk factors. The odds of sexual violence were lower among AGYW aged 18-22 years and among Muslims. Engaging in sex and food insecurity increased chances for sexual violence. Prevalence of recent violence among AGYW is high in this population. This calls for increased effort geared towards addressing drivers of violence as an early entry point of HIV prevention effort in this vulnerable group.

We report on an effectiveness evaluation of the Youth Empowerment Solutions (YES) program. YES applies empowerment theory to an after-school program for middle school students. YES is an active learning curriculum designed to help youth gain confidence in themselves, think critically about their community, and work with adults to create positive community change. We employed a modified randomized control group design to test the hypothesis that the curriculum would enhance youth empowerment, increase positive developmental outcomes, and decrease problem behaviors. Our sample included 367 youth from 13 urban and suburban middle schools. Controlling for demographic characteristics and pretest outcome measures, we found that youth who received more components of the curriculum reported more psychological empowerment and prosocial outcomes and less antisocial outcomes than youth who received fewer of the intervention components. The results support both empowerment theory and program effectiveness.

Background Evaluation of complex interventions should include a process evaluation to give evaluators, researchers, and policy makers greater confidence in the outcomes reported from RCTs. Implementation fidelity can be part of a process evaluation and refers to the degree to which an intervention is delivered according to protocol. The aim of this implementation fidelity study was to evaluate to what extent a dialogue-based psychosocial intervention was delivered according to protocol. A modified conceptual framework for implementation fidelity was used to guide the analysis. Methods This study has an explanatory, sequential two-phase mixed methods design. Quantitative process data were collected longitudinally along with data collection in the RCT. Qualitative process data were collected after the last data collection point of the RCT. Descriptive statistical analyses were conducted to describe the sample, the intervention trajectories, and the adherence measures. A scoring system to clarify quantitative measurement of the levels of implementation was constructed. The qualitative data sources were analyzed separately with a theory-driven content analysis using categories of adherence and potential moderating factors identified in the conceptual framework of implementation fidelity. The quantitative adherence results were extended with the results from the qualitative analysis to assess which potential moderators may have influenced implementation fidelity and in what way. Results The results show that the core components of the intervention were delivered although the intervention trajectories were individualized. Based on the composite score of adherence, results show that 80.1% of the interventions in the RCT were implemented with high fidelity. Although it is challenging to assess the importance of each of the moderating factors in relation to the other factors and to their influence on the adherence measures, participant responsiveness, comprehensiveness of policy description, context, and recruitment appeared to be the most prominent moderating factors of implementation fidelity in this study. Conclusions This evaluation of implementation fidelity and the discussion of what constitutes high fidelity implementation of this intervention are crucial in understanding the factors influencing the trial outcome. The study also highlights important methodological considerations for researchers planning process evaluations and studies of implementation fidelity. Trial registration ClinicalTrials.gov , NCT02338869; registered 10/04/2014.

The value of the individual placement and support (IPS) programme in helping people with severe mental illness gain open employment is unknown in Europe. Our aim was to assess the effectiveness of IPS, and to examine whether its effect is modified by local labour markets and welfare systems. 312 patients with severe mental illness were randomly assigned in six European centres to receive IPS (n=156) or vocational services (n=156). Patients were followed up for 18 months. The primary outcome was the difference between the proportions of people entering competitive employment in the two groups. The heterogeneity of IPS effectiveness was explored with prospective meta-analyses to establish the effect of local welfare systems and labour markets. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, with the number NCT00461318. IPS was more effective than vocational services for every vocational outcome, with 85 (55%) patients assigned to IPS working for at least 1 day compared with 43 (28%) patients assigned to vocational services (difference 26·9%, 95% CI 16·4–37·4). Patients assigned to vocational services were significantly more likely to drop out of the service and to be readmitted to hospital than were those assigned to IPS (drop-out 70 [45%] vs 20 [13%]; difference −32·1% [95% CI −41·5 to −22·7]; readmission 42 [31%] vs 28 [20%]; difference −11·2% [−21·5 to −0·90]). Local unemployment rates accounted for a substantial amount of the heterogeneity in IPS effectiveness. Our demonstration of the effectiveness of IPS in widely differing labour market and welfare contexts confirms this service to be an effective approach for vocational rehabilitation in mental health that deserves investment and further investigation.

Health care providers are a trusted and accurate source of sexual health information for most adolescents, and clinical guidelines recommend that all youth receive comprehensive, confidential sexual health information and services. However, these guidelines are followed inconsistently. Providers often lack the time, comfort, and skills to provide patient-centered comprehensive contraceptive counseling and services. There are significant disparities in the provision of sexual health services for Latino adolescents, which contribute to disproportionately higher rates of teenage pregnancy. To address this, we developed Health-E You or Salud iTu in Spanish, an evidence-informed mobile health (mHealth) app, to provide interactive, individually tailored sexual health information and contraception decision support for English and Spanish speakers. It is designed to be used in conjunction with a clinical encounter to increase access to patient-centered contraceptive information and services for adolescents at risk of pregnancy. Based on user input, the app provides tailored contraceptive recommendations and asks the youth to indicate what methods they are most interested in. This information is shared with the provider before the in-person visit. The app is designed to prepare youth for the visit and acts as a clinician extender to support the delivery of health education and enhance the quality of patient-centered sexual health care. Despite the promise of this app, there is limited research on the integration of such interventions into clinical practice. This study described efforts used to support the successful adoption and implementation of the Health-E You app in clinical settings and described facilitators and barriers encountered to inform future efforts aimed at integrating mHealth interventions into clinical settings. This study was part of a larger, cluster randomized control trial to evaluate the effectiveness of Health-E You on its ability to reduce health disparities in contraceptive knowledge, access to contraceptive services, and unintended pregnancies among sexually active Latina adolescents at 18 school-based health centers (SBHCs) across Los Angeles County, California. App development and implementation were informed by the theory of diffusion of innovation, the Patient-Centered Outcomes Research Institute's principles of engagement, and iterative pilot testing with adolescents and clinicians. Implementation facilitators and barriers were identified through monthly conference calls, site visits, and quarterly in-person collaborative meetings. Implementation approaches enhanced the development, adoption, and integration of Health-E You into SBHCs. Implementation challenges were also identified to improve the integration of mHealth interventions into clinical settings. This study provides important insights that can inform and improve the implementation efforts for future mHealth interventions. In particular, an implementation approach founded in a strong theoretical framework and active engagement with patient and community partners can enhance the development, adoption, and integration of mHealth technologies into clinical practice. ClinicalTrials.gov NCT02847858; https://clinicaltrials.gov/ct2/show/NCT02847858 (Archived by WebCite at http://www.webcitation.org/761yVIRTp).

BACKGROUND: Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. METHODS: Families (n = 160 8-12-year-old children and their parents/guardians) were randomized to intervention (n = 81) or control (n = 79) groups. Data were collected at baseline (2011–2012), post-intervention (12-months post-baseline) and follow-up (21-months post-baseline). The intervention included ten monthly group sessions (nutrition education; hands-on meal and snack planning, preparation, and skill development; screen time reductions) and five motivational, goal-setting phone calls. The main outcome was child body mass index (BMI) z-score. RESULTS: General linear models, adjusted for baseline values and demographics, showed no significant treatment group differences in BMI z-scores at post-intervention or follow-up; however, a promising reduction in excess weight gain was observed. Post-hoc stratification by pubertal onset indicated prepubescent children in the intervention group had significantly lower BMI z-scores than their control group counterparts. CONCLUSIONS: The study used a strong theoretical framework, rigorous design, quality measurement and a program with high fidelity to test a family meals-focused obesity prevention intervention. It showed a modest decrease in excess weight gain. The significant intervention effect among prepubescent children suggests the intervention may be more efficacious among relatively young children, although more research with appropriately powered samples are needed to replicate this finding. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01538615. Registered 01/17/2012.

Researchers often analyze cancer registry data to assess for differences in survival among cancer treatments. However, the retrospective, nonrandomized design of these analyses raises questions about study validity. To examine the extent to which comparative effectiveness analyses using observational cancer registry data produce results concordant with those of randomized clinical trials. In this comparative effectiveness study, a total of 141 randomized clinical trials referenced in the National Comprehensive Cancer Network Clinical Practice Guidelines for 8 common solid tumor types were identified. Data on participants within the National Cancer Database (NCDB) diagnosed between 2004 and 2014, matching the eligibility criteria of the randomized clinical trial, were obtained. The present study was conducted from August 1, 2017, to September 10, 2019. The trials included 85 118 patients, and the corresponding NCDB analyses included 1 344 536 patients. Three Cox proportional hazards regression models were used to determine hazard ratios (HRs) for overall survival, including univariable, multivariable, and propensity score-adjusted models. Multivariable and propensity score analyses controlled for potential confounders, including demographic, comorbidity, clinical, treatment, and tumor-related variables. The main outcome was concordance between the results of randomized clinical trials and observational cancer registry data. Hazard ratios with an NCDB analysis were considered concordant if the NDCB HR fell within the 95% CI of the randomized clinical trial HR. An NCDB analysis was considered concordant if both the NCDB and clinical trial P values for survival were nonsignificant (P ≥ .05) or if they were both significant (P < .05) with survival favoring the same treatment arm in the NCDB and in the randomized clinical trial. Analyses using the NCDB-produced HRs for survival were concordant with those of 141 randomized clinical trials in 79 univariable analyses (56%), 98 multivariable analyses (70%), and 90 propensity score models (64%). The NCDB analyses produced P values concordant with randomized clinical trials in 58 univariable analyses (41%), 65 multivariable analyses (46%), and 63 propensity score models (45%). No clinical trial characteristics were associated with concordance between NCDB analyses and randomized clinical trials, including disease site, type of clinical intervention, or severity of cancer. The findings of this study suggest that comparative effectiveness research using cancer registry data often produces survival outcomes discordant with those of randomized clinical trial data. These findings may help provide context for clinicians and policy makers interpreting observational comparative effectiveness research in oncology.

Background A healthy diet is an important component of secondary prevention of coronary heart disease (CHD). The TEXT ME study was a randomised clinical trial of people with CHD that were randomised into standard care or a text-message programme in addition to standard care. This analysis aimed to: 1) assess the effects of the intervention onadherence to the dietary guideline recommendations; 2) assess the consistency of effect across sub-groups; and 3) assess whether adherence to the dietary guideline recommendations mediated the improvements in objective clinical outcomes. Methods Dietary data were collected using a self-report questionnaire to evaluate adherence to eight dietary guideline recommendations in Australia, including consumption of vegetables, fruits, fish, type of fat used for cooking and in spreads, takeaway food, salt and standard alcohol drinks. The primary outcome of this analysis was the proportion of patients adhering to ≥ 4 dietary guideline recommendations concomitantly and each recommendation was assessed individually as secondary outcomes. Data were analysed using log-binomial regression for categorical variables and analysis of covariance for continuous variables. Results Among 710 patients, 54% were adhering to ≥ 4 dietary guideline recommendations (intervention 53% vs control 56%, p  = 0.376) at baseline. At six months, the intervention group had a significantly higher proportion of patients adhering to ≥ 4 recommendations (314, 93%) compared to the control group (264, 75%, RR 1.23, 95% CI 1.15–1.31, p  < 0.001). In addition, the intervention patients reported consuming higher amounts of vegetables, fruits, and fish per week; less takeaway foods per week; and greater salt intake control. The intervention had a similar effect in all sub-groups tested. There were significant mediational effects of the increase in adherence to the recommendations for the association between the intervention and LDL-cholesterol ( p  < 0.001) and body mass index (BMI) at six months follow-up ( p  = 0.005). Conclusion A lifestyle-focused text-message programme improved adherence to the dietary guideline recommendations, and specifically improved self-reported consumption of vegetables, fruits, fish, takeaway foods and salt intake. Importantly, these improvements partially mediated improvements in LDL-cholesterol and BMI. This simple and scalable text-messaging intervention could be used as a strategy to improve diet in people with CHD. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12611000161921 . Registered on 10 February 2011.

Background The prevalence of type 2 diabetes mellitus is increasing substantially worldwide, leading to serious economic effects, complications and deaths. This study evaluated the effectiveness of an empowerment program providing support for psychosocial, behavioral, and clinical aspects of diabetes to help Brazilian users of public health services obtain metabolic control of this condition. Methods In this cluster randomized trial, participants aged 30–80 diagnosed with type 2 diabetes were recruited from ten Brazilian public health units in 2014 and 2015. Five units were randomly assigned to receive the empowerment program based on a behavior change protocol, and five continued to receive only conventional treatment. The primary outcome was the biochemical and anthropometric parameters, and the secondary outcomes were self-care, attitude, knowledge and empowerment related to diabetes. The effect of the experiment was defined as the percentage variation between the values at the initial and final periods. To evaluate this effect and to compare it in the two groups, tests were used for paired and independent samples, respectively. Results There were 238 participants: 127 and 111 in the intervention and control group, respectively. For glycated hemoglobin, the mean effect in the control and intervention groups was 3.93 and −5.13, respectively ( p  < 0.001). Levels of glycated hemoglobin and other metabolic indicators, as well as the most part of the secondary outcomes showed a significant difference in the experimental group compared to the control group. Conclusions The empowerment program improved metabolic control of type 2 diabetes in Brazilian users. Trial registration NCT02132338 - April 22, 2014.