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BackgroundTo facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth interventions require changes in the behavior of patients and providers, creating considerable complexity and ambiguity related to causal chains. Process evaluations of the implementation are necessary to shed light on the range of unanticipated effects an intervention may have, what the active ingredients in everyday practice are, how they exert their effect, and how these may vary among recipients or between sites. ObjectiveBuilding on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement and participatory evaluation theory, we present a framework for the process evaluations for mHealth interventions in multiple cultural settings. We also describe the application of this evaluation framework to the implementation of DREAM-GLOBAL (Diagnosing hypertension—Engaging Action and Management in Getting Lower BP in Indigenous and LMIC [low- and middle-income countries]), a pragmatic randomized controlled trial (RCT), and mHealth intervention designed to improve hypertension management in low-resource environments. We describe the evaluation questions and the data collection processes developed by us. MethodsOur literature review revealed that there is a significant knowledge gap related to the development of a process evaluation framework for mHealth interventions. We used community-based participatory research (CBPR) methods and formative research data to develop a process evaluation framework nested within a pragmatic RCT. ResultsFour human organizational levels of participants impacted by the mHealth intervention were identified that included patients, providers, community and organizations actors, and health systems and settings. These four levels represent evaluation domains and became the core focus of the evaluation. In addition, primary implementation themes to explore in each of the domains were identified as follows: (1) the major active components of the intervention, (2) technology of the intervention, (3) cultural congruence, (4) task shifting, and (5) unintended consequences. Using the four organizational domains and their interaction with primary implementation themes, we developed detailed evaluation research questions and identified the data or information sources to best answer our questions. ConclusionsUsing DREAM-GLOBAL to illustrate our approach, we succeeded in developing an uncomplicated process evaluation framework for mHealth interventions that provide key information to stakeholders, which can optimize implementation of a pragmatic trial as well as inform scale up. The human organizational level domains used to focus the primary implementation themes in the DREAM-GLOBAL process evaluation framework are sufficiently supported in our research, and the literature and can serve as a valuable tool for other mHealth process evaluations. Trial RegistrationClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege)

BackgroundMobile-cellular subscriptions have increased steadily over the past decade. The accessibility of SMS messages over existing mobile networks is high and has almost universal availability even on older and unsophisticated mobile phones and in geographic settings where wireless coverage is weak. There is intensive exploration of this inexpensive mobile telecommunication technology to improve health services and promote behavior change among vulnerable populations. However, a neglected area of research is the documentation and critical analysis of the formative research process required in the development and refinement of effective SMS messages. ObjectiveThe objective of this qualitative research study was to identify major factors that may impact on the effectiveness of evidence-based SMS messages designed to reduce health inequities in hypertension management in low resource settings, including Aboriginal populations in high-income countries and rural populations in low-income countries. Specifically, we were interested in uncovering the range of mediators that impact on appropriate message content transmission and, ultimately, on health behavior improvements in a range of these sociocultural settings. MethodsCollaborative qualitative research with Canadian Aboriginal and Tanzanian participants was conducted to deconstruct the content and transmission of evidence-based health information contained in SMS messages in the context of an international research project designed to address health inequalities in hypertension, and to develop a grounded theory of the major factors that mediate the effectiveness of this communication. We also examined the interrelationship of these mediators with the three essential conditions of the behavior system of the Behavioral Change Wheel model (capability, opportunity, and motivation) and cultural safety. ResultsFour focus groups with a total of 45 participants were conducted. Our grounded theory research revealed how discrepancies develop between the evidence-based text message created by researchers and the message received by the recipient in mobile health interventions. These discrepancies were primarily generated by six mediators of meaning in SMS messages: (1) negative or non-affirming framing of advocacies, (2) fear- or stress-inducing content, (3) oppressive or authoritarian content, (4) incongruity with cultural and traditional practices, (5) disconnect with the reality of the social determinants of health and the diversity of cultures within a population, and (6) lack of clarity and/or practicality of content. These 6 mediators of meaning provide the basis for sound strategies for message development because they impact directly on the target populations’ capability, opportunity, and motivation for behavior change. ConclusionsThe quality of text messages impacts significantly on the effectiveness of a mobile health intervention. Our research underscores the urgent need for interventions to incorporate and evaluate the quality of SMS messages and to examine the mediators of meaning within each targeted cultural and demographic group. Reporting on this aspect of mobile health intervention research will allow researchers to move away from the current black box of SMS text message development, thus improving the transparency of the process as well as the quality of the outcomes.

Objective The purpose of this study was to determine the impact of a 1-day evidence-based medicine (EBM) workshop on physician attitudes and behaviours around teaching and practicing EBM. Design A mixed methods study using a before/after cohort. Setting A medical school delivering continuing professional development to 1250 clinical faculty over a large geographic area in Canada. Participants 105 physician clinical faculty members. Intervention A 1-day workshop presented at 11 different sites over an 18-month period focusing on EBM skills for teaching and clinical practice. Outcome measures (1) A quantitative survey administered immediately before and after the workshop, and 3-6 months later, to assess the hypothesis that comfort with teaching and practising EBM can be improved. (2) A qualitative survey of the expectations for, and impact of the workshop on, participant behaviours and attitudes using a combination of pre, post and 3 to 6-month follow-up questionnaires, and telephone interviews completed 10-14 months after the workshop. Results Physician comfort with their EBM clinical skills improved on average by 0.93 points on a 5-point Likert scale, and comfort with EBM teaching skills by 0.97 points (p values 0.001). Most of this improvement was sustained 3-6 months later. Three to fourteen months after the workshop, half of responding participants reported that they were using the Population Intervention Comparator Outcome (PICO) methodology of question framing for teaching, clinical practice or both. Conclusions Comfort in teaching and practicing EBM can be improved by a 1-day workshop, with most of this improvement sustained 3-6 months later. PICO question framing can be learnt at a 1-day workshop, and is associated with a self-reported change in clinical and teaching practice 3-14 months later. This represents both level 2 (attitudes) and level 3 (behaviours) change using the Kirkpatrick model of evaluation. [ABSTRACT FROM AUTHOR]

Background:  Participating in surveys can shape the perception of participants related to the study topic. Administering a vaccine hesitancy questionnaire can have negative impacts on participants' vaccine confidence. This is particularly true for online and cross-cultural data collection because culturally safe health education to correct misinformation is typically not provided after the administration of an electronic survey., Objective:  To create a culturally safe, online, COVID-19 vaccine confidence survey for Indigenous youth designed to collect authentic, culturally relevant data of their vaccine experiences, with a low risk of contributing to further vaccine confusion among participants., Methods:  Using the Aboriginal Telehealth Knowledge Circle consensus method, a team of academics, health care providers, policy makers, and community partners reviewed COVID-19 vaccine hesitancy surveys used in public health research, analyzed potential risks, and created a framework for electronic Indigenous vaccine confidence surveys as well as survey items., Results:  The framework for safer online survey items is based on 2 principles, a first do-no-harm approach and applying a strengths-based lens. Relevant survey domains identified in the process include sociodemographic information, participants' connection to their community, preferred sources for health information, vaccination uptake among family members and peers, as well as personal attitudes toward vaccines. A total of 44 survey items were developed, including 5 open-ended items to improve the authenticity of the data and the analysis of the experiences of Indigenous youth., Conclusions:  Using an Indigenous consensus method, we have developed an online COVID-19 vaccine confidence survey with culturally relevant domains and reduced the risk of amplifying misinformation and negative impacts on vaccine confidence among Indigenous participants. Our approach can be adapted to other online survey development in collaboration with Indigenous communities., (©Marion Maar, Caleigh Bourdon, Joahnna Berti, Emma Bisaillon, Lisa Boesch, Alicia Boston, Justin Chapdelaine, Alison Humphrey, Sandeep Kumar, Benjamin Maar-Jackson, Robert Martell, Bruce Naokwegijig, Davinder Preet Kaur, Sarah Rice, Barbara Rickaby, Mariette Sutherland, Maurianne Reade. Originally published in JMIR Formative Research (https://formative.jmir.org), 12.08.2024.)