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  Theme Issue (2018): Adolescent...

  May 23, 2019

  Implementation Science Research Examining the Integration of Evidence-Based Practices Into HIV Prevention and Clinical Care: Protocol for a Mixed-Methods...

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  Authors List:

  • April Idalski Carcone  
  • Karin Coyle  
  • Sitaji Gurung  
  • Demetria Cain  
  • Rafael E Dilones  
  • Laura Jadwin-Cakmak  
  • Jeffrey T Parsons  
  • Sylvie Naar  

  Abstract:

  Background: The Exploration, Preparation, Implementation, and Sustainment (EPIS) model is an implementation framework for studying the integration of evidence-based practices (EBPs) into real-world settings. The EPIS model conceptualizes implementation as a process starting with the earliest stages of problem recognition (Exploration) through the continued use of an EBP in a given clinical context (Sustainment). This is the first implementation science (IS) study of the integration of EBPs into adolescent HIV prevention and care settings. Objective: This protocol (ATN 153 EPIS) is part of the Scale It Up program, a research program administered by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN), described in this issue by Naar et al. The EPIS study is a descriptive study of the uptake of 4 EBPs within the Scale It Up program. The goal of EPIS is to understand the barriers and facilitators associated with the Preparation, Implementation, and Sustainment of EBPs into HIV prevention and clinical care settings. Methods: The EPIS study is a convergent parallel mixed-methods IS study. Key implementation stakeholders, that is, clinical care providers and leaders, located within 13 ATN sites across the United States will complete a qualitative interview conducted by telephone and Web-based surveys at 3 key implementation stages. The Preparation assessment occurs before EBP implementation, Implementation occurs immediately after sites finish implementation activities and prepare for sustainment, and Sustainment occurs 1 year postimplementation. Assessments will examine stakeholders’ perceptions of the barriers and facilitators to EBP implementation within their clinical site as outlined by the EPIS framework. Results: The EPIS baseline period began in June 2017 and concluded in May 2018; analysis of the baseline data is underway. To date, 153 stakeholders have completed qualitative interviews, and 91.5% (140/153) completed the quantitative survey. Conclusions: The knowledge gained from the EPIS study will strengthen the implementation and sustainment of EBPs in adolescent prevention and clinical care contexts by offering insights into the barriers and facilitators of successful EBP implementation and sustainment in real-world clinical contexts. International Registered Report Identifier (IRRID): DERR1-10.2196/11202

  • JMIR Res Protoc 2019;8(5):e11202

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  Grant Proposals (eHealth, funded)

  May 23, 2019

  A Patient-Centered Mobile Phone App (iHeartU) With a Virtual Human Assistant for Self-Management of Heart Failure: Protocol for a Usability Assessment Study

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  Authors List:

  • Lingling Zhang  
  • Sabarish V Babu  
  • Meenu Jindal  
  • Joel E Williams  
  • Ronald W Gimbel  

  Abstract:

  Background: Heart failure (HF) causes significant economic and humanistic burden for patients and their families, especially those with a low income, partly due to high hospital readmission rates. Optimal self-care is considered an important nonpharmacological aspect of HF management that can improve health outcomes. Emerging evidence suggests that self-management assisted by smartphone apps may reduce rehospitalization rates and improve the quality of life of patients. We developed a virtual human–assisted, patient-centered mobile health app (iHeartU) for patients with HF to enhance their engagement in self-management and improve their communication with health care providers and family caregivers. iHeartU may help patients with HF in self-management to reduce the technical knowledge and usability barrier while maintaining a low cost and natural, effective social interaction with the user. Objective: With a standardized systematic usability assessment, this study had two objectives: (1) to determine the obstacles to effective and efficient use of iHeartU in patients with HF and (2) to evaluate of HF patients’ adoption, satisfaction, and engagement with regard to the of iHeartU app. Methods: The basic methodology to develop iHeartU systems consists of a user-centric design, development, and mixed methods formative evaluation. The iterative design and evaluation are based on the guidelines of the American College of Cardiology Foundation and American Heart Association for the management of heart failure and the validated “Information, Motivation, and Behavioral skills” behavior change model. Our hypothesis is that this method of a user-centric design will generate a more usable, useful, and easy-to-use mobile health system for patients, caregivers, and practitioners. Results: The prototype of iHeartU has been developed. It is currently undergoing usability testing. As of September 2018, the first round of usability testing data have been collected. The final data collection and analysis are expected to be completed by the end of 2019. Conclusions: The main contribution of this project is the development of a patient-centered self-management system, which may support HF patients’ self-care at home and aid in the communication between patients and their health care providers in a more effective and efficient way. Widely available mobile phones serve as care coordination and “no-cost” continuum of care. For low-income patients with HF, a mobile self-management tool will expand their accessibility to care and reduce the cost incurred due to emergency visits or readmissions. The user-centered design will improve the level of engagement of patients and ultimately lead to better health outcomes. Developing and testing a novel mobile system for patients with HF that incorporates chronic disease management is critical for advancing research and clinical practice of care for them. This research fills in the gap in user-centric design and lays the groundwork for a large-scale population study in the next phase. International Registered Report Identifier (IRRID): DERR1-10.2196/13502

  • JMIR Res Protoc 2019;8(5):e13502

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  RCTs - Protocols/Proposals (funded,...

  May 21, 2019

  Evaluating the Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes in People Living With...

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  Authors List:

  • Adria Quigley  
  • Kelly K O'Brien  
  • Marie-Josée Brouillette  
  • Marilyn MacKay-Lyons  

  Abstract:

  Background: Despite lower mortality rates due to combination antiretroviral therapy, people living with HIV (PLWH) are grappling with increasingly complex health issues, including cognitive impairments in areas such as memory, attention, processing speed, and motor function. Yoga has been shown to be an effective form of exercise and mindfulness-based stress reduction for many clinical populations. However, no randomized trials have evaluated the impact of yoga on cognitive and physical function among PLWH. Objective: The aim of this pilot randomized trial was to determine the feasibility of a yoga intervention to lay the groundwork for a full-scale, multisite, community-based trial for PLWH. Specific objectives are to (1) assess the feasibility of study protocol and procedures, (2) compare cognition in the yoga group with the usual care control group after 12 weeks of the intervention in PLWH, and (3) compare the effects of the 12-week yoga intervention versus control on balance, walking speed, physical activity, mental health, medication adherence, and quality of life among PLWH. Methods: We propose a pilot randomized trial with 2 parallel groups (yoga versus control). We will recruit 25 PLWH (>35 years) from community and health organizations in Halifax, Canada. After baseline assessment with blinded assessors, participants will be randomly assigned to the yoga or control group, using a random computer generator. Participants in the yoga group will engage in supervised 60-min group-based yoga sessions 3 times a week for 12 weeks at a yoga studio. Participants in the control group will maintain their current physical activity levels throughout the study. Results: As per the Consolidated Standards of Reporting Trials extension for pilot studies, means of all outcomes, mean change, and 95% CIs will be calculated for each group separately. Two-tailed independent t tests and Fisher exact tests will be used to compare groups at baseline. We will analyze quantitative postintervention questionnaire responses using Chi-square tests, and open-ended responses will be analyzed thematically. Intention-to-treat and per-protocol analyses will be used to analyze secondary variables. Changes in outcome variables will be examined between groups and within groups. Effect sizes will be reported for each outcome. A priori adherence and satisfaction criteria will be met if participants attend >70% of the yoga sessions and if >70% of the participants are satisfied with the intervention as determined by a postparticipation questionnaire. Study enrollment began in January 2018, with results expected for October 2019. Conclusions: This pilot randomized trial will be the first to investigate the feasibility and effect of a yoga intervention on cognitive and physical outcomes among PLWH. This work will inform the feasibility of further investigations in terms of capacity building, participant recruitment and retention, and assessment and intervention protocols. Trial Registration: ClinicalTrials.gov NCT03071562; https://clinicaltrials.gov/ct2/show/NCT03071562 (Archived by WebCite at http://www.webcitation.org/785sfhWkw) International Registered Report Identifier (IRRID): DERR1-10.2196/13818

  • JMIR Res Protoc 2019;8(5):e13818

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  Theme Issue (2018): Adolescent...

  May 21, 2019

  Clinic-Based Delivery of the Young Men’s Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men:...

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  Authors List:

  • Jeffrey T Parsons  
  • Tyrel Starks  
  • Sitaji Gurung  
  • Demetria Cain  
  • Jonathan Marmo  
  • Sylvie Naar  

  Abstract:

  Background: Young men who have sex with men (YMSM) are disproportionately at risk for HIV and sexually transmitted infections. Adapting and testing the effectiveness of the Young Men’s Health Project (YMHP), an efficacious intervention designed to reduce substance use and condomless anal sex (CAS) among YMSM, at clinics in Miami, Detroit, and Philadelphia has the potential to reduce HIV and STI disparities among urban YMSM. Objective: This study (Adolescent Medicine Trials Network for HIV/AIDS Interventions [ATN] 145 YMHP) aims to adapt YMHP for clinic and remote delivery by existing clinic staff and compare their effectiveness in real-world adolescent HIV clinics. This protocol is part of the ATN Scale It Up program described in a recently published article by Naar et al. Methods: This is a comparative effectiveness hybrid type-2 trial of the YMHP intervention with 2 delivery formats—clinic-based versus remote delivery—offered following HIV counseling and testing. Phase 1 includes conducting focus groups with youth to obtain implementation feedback about the delivery of the YMHP intervention and intervention components to ensure culturally competent, feasible, and scalable implementation. Phase 2 includes recruitment and enrollment of 270 YMSM, aged 15 to 24 years, 90 at each of the 3 sites. Enrollment will be limited to HIV-negative YMSM who report recent substance use and either CAS or a positive STI test result. Participants will be randomized to receive the YMHP intervention either in person or by remote delivery. Both conditions involve completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis information and navigation services. A minimum of 2 community health workers (CHWs) will be trained to deliver the intervention sessions at each site. Sessions will be audio-recorded for Motivational Interviewing Treatment Integrity (MITI) fidelity coding, and CHWs and supervisors will be given implementation support throughout the study period. Results: Phase 1 focus groups were completed in July 2017 (n=25). Feedback from these focus groups at the 3 sites informed adaptations to the YMHP intervention manual, implementation of the intervention, and recruitment plans for phase 2. Baseline enrollment for phase 2 began in November 2018, and assessments will be at immediate posttest (IP)-, 3-, 6-, 9-, and 12-months after the intervention. Upon collection of both baseline and follow-up data, we will compare the effectiveness and cost-effectiveness of clinic-based versus remote delivery of YMHP in the context of health care access. Conclusions: We are conducting YMHP in 3 cities with high rates of YMSM at risk for HIV and STIs. When adapted for real-world clinics, this study will help substance-using YMSM at risk for HIV and STIs and allow us to examine differences in effectiveness and cost by the method of delivery. Trial Registration: ClinicalTrials.gov NCT03488914; https://clinicaltrials.gov/ct2/show/NCT03488914 (Archived by WebCite at http://www.webcitation.org/770WaWWfi) International Registered Report Identifier (IRRID): DERR1-10.2196/11184

  • JMIR Res Protoc 2019;8(5):e11184

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  RCTs - Protocols/Proposals (eHealth)

  May 17, 2019

  Evaluating a Web-Based Mental Health Service for Secondary School Students in Australia: Protocol for a Cluster Randomized Controlled Trial

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  Authors List:

  • Bridianne O'Dea  
  • Catherine King  
  • Mirjana Subotic-Kerry  
  • Melissa Anderson  
  • Melinda Rose Achilles  
  • Belinda Parker  
  • Andrew Mackinnon  
  • Josey Anderson  
  • Nicole Cockayne  
  • Helen Christensen  

  Abstract:

  Background: Mental health problems are prevalent among Australian secondary school youth; however, help-seeking is low. Schools offer an ideal setting to address these concerns. The Black Dog Institute has developed a Web-based mental health service for secondary schools that is modeled on the principles of stepped care. The Smooth Sailing service aims to improve help-seeking and reduce anxiety and depressive symptoms in secondary school students. The acceptability of this service has been demonstrated in a pilot study. A full trial is now warranted. Objective: This study protocol for a cluster randomized controlled trial (RCT) aims to evaluate the effectiveness of the Smooth Sailing Web-based service for improving help-seeking intentions and behavior, and reducing depressive and anxiety symptoms, alongside other mental health outcomes, when compared with a school-as-usual control condition in secondary school youth. Methods: This RCT aims to recruit 1600 students from 16 secondary schools in regional and urban locations throughout New South Wales, Australia. Schools are randomly assigned to the intervention or school-as-usual control condition at the school level. Approximately 100 students from 1 or multiple grades are recruited from each participating school. Participants complete measures at 3 timepoints: baseline, 6 weeks post, and 12 weeks post, with the primary outcome assessed at 12 weeks posttest. Participants assigned to the intervention condition register to the Web-based service at baseline and receive care in accordance with the service model. Participants in the control condition receive school-as-usual. Results: The first baseline assessment occurred on February 22, 2018, with the 12-week endpoint assessments completed on Friday, June 29, 2018. Control schools are currently receiving the service, due for completion by June 30, 2019. The trial results are expected to demonstrate improved help-seeking intentions and behavior among students assigned to the intervention condition, alongside improvements in symptoms of depression, anxiety, distress, and other mental health outcomes when compared with students assigned to the control condition. Conclusions: To our knowledge, this is the first time that a Web-based mental health service based on the principles of stepped care will have been integrated into, and evaluated in, the Australian school context. The findings of this trial will have implications for the suitability of this type of service model in Australian schools and for the delivery of school-based mental health services more broadly. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001539224 https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375821&isReview=true (Archived by WebCite at http://www.webcitation.org/77N3MDGS6) International Registered Report Identifier (IRRID): DERR1-10.2196/12892

  • JMIR Res Protoc 2019;8(5):e12892

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  RCTs - Protocols/Proposals (funded,...

  May 16, 2019

  Implementing Systematic Screening and Structured Care for Distressed Callers Using Cancer Council’s Telephone Services: Protocol for a Randomized...

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  Authors List:

  • Elizabeth A Fradgley  
  • Anna Boltong  
  • Lorna O'Brien  
  • Allison W Boyes  
  • Katherine Lane  
  • Annette Beattie  
  • Tara Clinton-McHarg  
  • Paul B Jacobsen  
  • Christopher Doran  
  • Daniel Barker  
  • Della Roach  
  • Jo Taylor  
  • Christine L Paul  

  Abstract:

  Background: Structured distress management, comprised a 2-stage screening and referral model, can direct supportive care resources toward individuals who are most likely to benefit. This structured approach has yet to be trialed in Australian community-based services such as Cancer Council New South Wales (NSW) and Victoria Cancer Information and Support (CIS) 13 11 20 lines who care for a large community of cancer patients and caregivers. Objective: The aim of this study was to evaluate the effectiveness of structured screening and referral in (1) increasing the proportion of distressed CIS callers who accept supportive care referrals and (2) reducing distress levels at 6-month follow-up. Methods: In this stepped-wedge trial, Cancer Council NSW and Victoria CIS consultants are randomized to deliver structured care during inbound 13 11 20 calls in accordance with 3 intervention periods. Eligible callers are patients or caregivers who score 4 or more on the Distress Thermometer; NSW or Victorian residents; aged 18 years or older; and English proficient. Study data are collected via computer-assisted telephone interviews (CATIs) at 3- and 6-month follow-up and CIS record audit. CATIs include demographic and service use items and the General Health Questionnaire (GHQ-28) to assess distress. An economic analysis of the structured care model will be completed. Results: The structured care model was developed by guideline review and identification of service characteristics to guide mapping decisions; place-card methodology; and clinical vignettes with think-aloud methodology to confirm referral appropriateness. The model includes an additional screening tool (Patient Health Questionnaire-4) and a referral model with 16-20 CIS services. Descriptive statistics will be used to assess referral uptake rates. Differences between GHQ-28 scores for structured and usual care callers will be tested using a generalized linear mixed model with fixed effects for intervention and each time period. The trial will recruit 1512 callers. The sample size will provide the study with approximately 80% power to detect a difference of 0.3 SD in the mean score of the GHQ-28 at an alpha level of .05 and assuming an intra-cluster correlation of .04. A random sample of recorded calls will be reviewed to assess intervention fidelity and contamination. To date, 1835 distressed callers have been invited to participate with 60.71% (1114/1835) enrolled in the study. A total of 692 participants have completed 6-month CATIs. Recruitment is anticipated to end in late 2019. Conclusions: This trial is among the first to rigorously test the outcomes of a community-based structured approach to distress management. The model is evidence-informed, practice-ready, and trialed in a real-world setting. The study outcomes will advance the understanding of distress management internationally for both patients and caregivers. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617000352303; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372105&isReview=true (Archived by WebCite on http://www.webcitation.org/78AW0Ba09) International Registered Report Identifier (IRRID): DERR1-10.2196/12473

  • JMIR Res Protoc 2019;8(5):e12473

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  RCTs - Protocols/Proposals (eHealth)

  May 15, 2019

  Web-Based Skin Cancer Prevention Training for Massage Therapists: Protocol for the Massage Therapists Skin Health Awareness, Referral, and Education Study

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  Authors List:

  • Lois J Loescher  
  • Kelly M Heslin  
  • Laura A Szalacha  
  • Graciela E Silva  
  • Myra L Muramoto  

  Abstract:

  Background: Skin cancer, the most common cancer in the United States, is costly and potentially deadly. Its burden can be reduced by early detection and prevention activities. The scope of skin cancer requires going beyond traditional health care providers to promote risk reduction. Partnering with the nonbiomedical workforce, such as massage therapists (MTs), may reach more individuals at risk. MTs see much of their clients’ skin and are amenable to performing skin cancer risk reduction activities during massage appointments. Objective: The objective of this study is to describe the Massage Therapists Skin Health Awareness, Referral, and Education protocol, presenting an overview of our systematic approach to developing rigorous e-training for MTs to enable them to be partners in skin cancer risk reduction. We also describe procedures for usability and feasibility testing of the training. Methods: We developed an integrated electronic learning system that includes electronic training (e-training) technology, simulated client interactions, online data collection instruments, and in-person assessment of MTs’ application of their training. Results: A total of 20 participants nationally scored the e-training as high for usability and satisfaction. We have screened an additional 77 MTs in Arizona for interest and eligibility, and currently have 37 enrolled participants, of whom 32 have completed the Web-based training. Conclusions: The structured and rigorous development approach for this skin cancer risk reduction and brief behavioral intervention e-training for MTs begins to fill a gap in skin cancer risk reduction research. Iterative usability testing of our asynchronous Web-based training resulted in positive participant response. Our e-training approach offers greater learner accessibility, increased convenience, and greater scalability than the few existing programs and has the potential to reach many MTs nationally. International Registered Report Identifier (IRRID): DERR1-10.2196/13480

  • JMIR Res Protoc 2019;8(5):e13480

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  RCTs - Protocols/Proposals (funded,...

  May 13, 2019

  A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a...

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  Authors List:

  • Jolie N Haun  
  • Lisa M Ballistrea  
  • Christine Melillo  
  • Maisha Standifer  
  • Kevin Kip  
  • Jacquelyn Paykel  
  • Jennifer L Murphy  
  • Carol E Fletcher  
  • Allison Mitchinson  
  • Leila Kozak  
  • Stephanie L Taylor  
  • Shirley M Glynn  
  • Matthew Bair  

  Abstract:

  Background: Complementary and integrative health (CIH) is a viable solution to PTSD and chronic pain. Many veterans believe CIH can be performed only by licensed professionals in a health care setting. Health information technology can bring effective CIH to veterans and their partners. Objective: This paper describes the rationale, design, and methods of the Mission Reconnect protocol to deliver mobile and Web-based complementary and integrative health programs to veterans and their partners (eg, spouse, significant other, caregiver, or family member). Methods: This three-site, 4-year mixed-methods randomized controlled trial uses a wait-list control to determine the effects of mobile and Web-based CIH programs for veterans and their partners, or dyads. The study will use two arms (ie, treatment intervention arm and wait-list control arm) in a clinical sample of veterans with comorbid pain and posttraumatic stress disorder, and their partners. The study will evaluate the effectiveness and perceived value of the Mission Reconnect program in relation to physical and psychological symptoms, global health, and social outcomes. Results: Funding for the study began in November 2018, and we are currently in the process of recruitment screening and data randomization for the study. Primary data collection will begin in May 2019 and continue through May 2021. Projected participants per site will be 76 partners/dyads, for a total of 456 study participants. Anticipated study results will be published in November 2022. Conclusions: This work highlights innovative delivery of CIH to veterans and their partners for treatment of posttraumatic stress disorder and chronic pain. Trial Registration: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 (Archived by WebCite at http://www.webcitation.org/77Q2giwtw) International Registered Report Identifier (IRRID): PRR1-10.2196/13666

  • JMIR Res Protoc 2019;8(5):e13666

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  RCTs - Protocols/Proposals (non-eHealth)

  May 13, 2019

  Communicating Uncertainty From Limitations in Quality of Evidence to the Public in Written Health Information: Protocol for a Web-Based Randomized Controlled...

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  Authors List:

  • Roland Brian Büchter  
  • Cornelia Betsch  
  • Martina Ehrlich  
  • Dennis Fechtelpeter  
  • Ulrich Grouven  
  • Sabine Keller  
  • Regina Meuer  
  • Constanze Rossmann  
  • Andreas Waltering  

  Abstract:

  Background: Uncertainty is integral to evidence-informed decision making and is of particular importance for preference-sensitive decisions. Communicating uncertainty to patients and the public has long been identified as a goal in the informed and shared decision-making movement. Despite this, there is little quantitative research on how uncertainty in health information is perceived by readers. Objective: The objective of this study is to design an experiment to examine how different degrees of uncertainty (Q1) and different types of uncertainty (Q2) impact patients’ perception of treatment effectiveness, the body of evidence, text quality, and hypothetical treatment intention. The experiment also examines whether there is an additive effect when multiple sources of uncertainty are communicated (Q3). Methods: We developed 8 variations of a research summary set in a hypothetical scenario for a treatment decision in the context of tinnitus. These were modified only in the degree of uncertainty relating to the evidence of the presented treatment. We recruited members of the German public from a Web-based research panel and randomized them to one of 8 variations of the research summary to examine the 3 research questions. The trial was only open to the members of the research panel. The outcomes are perception of the effectiveness of the treatment (primary), certainty in the judgement of treatment effectiveness, perception of the body of evidence relating to the treatment, text quality, and decisional intention (secondary). Outcomes were self-assessed. We aimed to recruit 1500 participants to the trial. The recruitment and data collection was fully automated. Ethical approval was waivered by an ethics committee because of the negligible risk to participants. Results: This protocol is retrospectively published in its original format. In the meantime, the trial was set up and the data collection was completed. Data collection was conducted in May 2018. A total of 1727 eligible panel members were enrolled. Conclusions: We aim to publish the results in a peer-reviewed journal by the end of 2019. In addition, results will be presented at conferences and disseminated among developers of guidance for the development of evidence-based health information and decision aids. Trial Registration: German Clinical Trials Register DRKS00015911; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00015911 (Archived by WebCite at http://www.webcitation.org/77zyZTGzk) International Registered Report Identifier (IRRID): RR1-10.2196/13425

  • JMIR Res Protoc 2019;8(5):e13425

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  Non-Randomized Study Protocols and...

  May 9, 2019

  Household Surveys in the General Population and Web-Based Surveys in IQOS Users Registered at the Philip Morris International IQOS User Database: Protocols...

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  Authors List:

  • Zheng Sponsiello-Wang  
  • Peter Langer  
  • Luis Prieto  
  • Mariia Dobrynina  
  • Dimitra Skiada  
  • Nathalie Camille  
  • Rolf Weitkunat  
  • Frank Lüdicke  

  Abstract:

  Background: Philip Morris International (PMI) has developed a novel heat-not-burn tobacco product, Tobacco Heating System (THS), which is marketed under the brand name of IQOS with HEETS (IQOS). The aerosol generated by THS has substantially fewer toxicants than combustible cigarette smoke, although the extent of the reduction of harmful and potentially harmful constituents reported varies between studies. To evaluate the potential harm reduction associated with IQOS use, the assessment of the uptake and continued use of IQOS in the context of all other tobacco- and nicotine-containing products is crucial. In March 2018, PMI launched cross-sectional surveys in Germany, Italy, and the United Kingdom (Greater London) to estimate the prevalence and use patterns of IQOS and other tobacco- and nicotine-containing products use in these 3 markets following the commercialization of IQOS. This study describes the protocol of the surveys. Objective: The objectives of these surveys are to estimate the prevalence of tobacco- and nicotine-containing products use; describe past and current patterns of use; and explore their associations with self-reported health, motivation to use, risk perceptions, and perceived aesthetic changes. Methods: The overall design of the surveys is similar in all 3 countries. Repeated cross-sectional surveys are being conducted annually over 3 consecutive years (2018 to 2020) and in 2 samples: a representative sample of the general population and a sample of IQOS users. A total of 6085 adults per year will be selected from the general population for each survey through multistage stratified sampling, and participants will respond to face-to-face computer-assisted personal interviews. In addition, 1404, 1384, and 1246 IQOS users per year in Germany, Italy, and Greater London, respectively, will be randomly selected from the PMI IQOS user database and will be invited to complete the Web-based survey using computer-assisted self-interviews. The Smoking Questionnaire is used to assess the tobacco use patterns of the participants. Results: The recruitment of the general population sample began in March 2018 and that of the IQOS user sample began in April 2018. The data collection is ongoing, and the results of the first year data analysis are expected to be available by June 2019. Conclusions: As the design of the 3 surveys is similar, the results will allow for cross-countries comparison of the prevalence of IQOS and other tobacco- and nicotine-containing products use as well as patterns of use and associated factors. International Registered Report Identifier (IRRID): DERR1-10.2196/12061

  • JMIR Res Protoc 2019;8(5):e12061

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  Non-Randomized Study Protocols and...

  May 8, 2019

  Testing a Communication Assessment Tool for Ethically Sensitive Scenarios: Protocol of a Validation Study

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  Authors List:

  • Thierry Daboval  
  • Natalie Ward  
  • Jordan R Schoenherr  
  • Gregory P Moore  
  • Caitlin Carew  
  • Alicia Lambrinakos-Raymond  
  • Emanuela Ferretti  

  Abstract:

  Background: Although well-designed instruments to assess communication during medical interviews and complex encounters exist, assessment tools that differentiate between communication, empathy, decision-making, and moral judgment are needed to assess different aspects of communication during situations defined by ethical conflict. To address this need, we developed an assessment tool that differentiates competencies associated with practice in ethically challenging situations. The competencies are grouped into three distinct categories: communication skills, civility and respectful behavior, clinical and ethical judgment and decision-making. Objective: The overall objective of this project is to develop an assessment tool for ethically sensitive scenarios that measures the degree of respect for the attitudes and beliefs of patients and family members, the demands of clinical decision-making, and the success in dealing with ethical conflicts in the clinical context. In this article, we describe the research method we will use during the pilot-test study using the neonatal context to provide validity evidence to support the features of the Assessment Communication Tool for Ethics (ACT4Ethics) instrument. Methods: This study is part of a multiphase project designed according to modern validity principles including content, response process, internal structure, relation to other variables, and social consequences. The design considers threats to validity such as construct underrepresentation and factors exerting nonrandom influence on scores. This study consists of two primary steps: (1) train the raters in the use of the new tool and (2) pilot-test a simulation using an Objective Structured Clinical Examination. We aim to obtain a total of 90 independent assessments based on the performance of 30 trainees rated by 15 trained raters for analysis. A comparison of raters’ responses will allow us to compute a measure of interrater reliability. We will additionally compare the results of ACT4Ethics with another existing instrument. Results: This study will take approximately 18 months to complete and the results should be available by September 2019. Conclusions: ACT4Ethics should allow clinician-teachers to assess and monitor the development of competency of trainees’ judgments and communication skills when facing ethically sensitive clinical situations. The instrument will also guide the provision of meaningful feedback to ensure that trainees develop specific communication, empathy, decision-making, and ethical competencies. International Registered Report Identifier (IRRID): PRR1-10.2196/12039

  • JMIR Res Protoc 2019;8(5):e12039

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  Non-Randomized Study Protocols and...

  May 7, 2019

  The Adverse Drug Reactions From Patient Reports in Social Media Project: Protocol for an Evaluation Against a Gold Standard

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  Authors List:

  • Armelle Arnoux-Guenegou  
  • Yannick Girardeau  
  • Xiaoyi Chen  
  • Myrtille Deldossi  
  • Rim Aboukhamis  
  • Carole Faviez  
  • Badisse Dahamna  
  • Pierre Karapetiantz  
  • Sylvie Guillemin-Lanne  
  • Agnès Lillo-Le Louët  
  • Nathalie Texier  
  • Anita Burgun  
  • Sandrine Katsahian  

  Abstract:

  Background: Social media is a potential source of information on postmarketing drug safety surveillance that still remains unexploited nowadays. Information technology solutions aiming at extracting adverse reactions (ADRs) from posts on health forums require a rigorous evaluation methodology if their results are to be used to make decisions. First, a gold standard, consisting of manual annotations of the ADR by human experts from the corpus extracted from social media, must be implemented and its quality must be assessed. Second, as for clinical research protocols, the sample size must rely on statistical arguments. Finally, the extraction methods must target the relation between the drug and the disease (which might be either treated or caused by the drug) rather than simple co-occurrences in the posts. Objective: We propose a standardized protocol for the evaluation of a software extracting ADRs from the messages on health forums. The study is conducted as part of the Adverse Drug Reactions from Patient Reports in Social Media project. Methods: Messages from French health forums were extracted. Entity recognition was based on Racine Pharma lexicon for drugs and Medical Dictionary for Regulatory Activities terminology for potential adverse events (AEs). Natural language processing–based techniques automated the ADR information extraction (relation between the drug and AE entities). The corpus of evaluation was a random sample of the messages containing drugs and/or AE concepts corresponding to recent pharmacovigilance alerts. A total of 2 persons experienced in medical terminology manually annotated the corpus, thus creating the gold standard, according to an annotator guideline. We will evaluate our tool against the gold standard with recall, precision, and f-measure. Interannotator agreement, reflecting gold standard quality, will be evaluated with hierarchical kappa. Granularities in the terminologies will be further explored. Results: Necessary and sufficient sample size was calculated to ensure statistical confidence in the assessed results. As we expected a global recall of 0.5, we needed at least 384 identified ADR concepts to obtain a 95% CI with a total width of 0.10 around 0.5. The automated ADR information extraction in the corpus for evaluation is already finished. The 2 annotators already completed the annotation process. The analysis of the performance of the ADR information extraction module as compared with gold standard is ongoing. Conclusions: This protocol is based on the standardized statistical methods from clinical research to create the corpus, thus ensuring the necessary statistical power of the assessed results. Such evaluation methodology is required to make the ADR information extraction software useful for postmarketing drug safety surveillance. International Registered Report Identifier (IRRID): RR1-10.2196/11448

  • JMIR Res Protoc 2019;8(5):e11448

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