JMIR Publications

Recent Articles:

• 

  Early Reports

  Apr 25, 2018

  Comparing the Effects of Combined Oral Contraceptives Containing Progestins With Low Androgenic and Antiandrogenic Activities on the...

  View Authors View Abstract

  Authors List:

  • Mina Amiri  
  • Fahimeh Ramezani Tehrani  
  • Fatemeh Nahidi  
  • Ali Kabir  
  • Fereidoun Azizi  

  Abstract:

  Background: Different products of combined oral contraceptives (COCs) can improve clinical and biochemical findings in patients with polycystic ovary syndrome (PCOS) through suppression of the hypothalamic-pituitary-gonadal (HPG) axis. Objective: This systematic review and meta-analysis aimed to compare the effects of COCs containing progestins with low androgenic and antiandrogenic activities on the HPG axis in patients with PCOS. Methods: We searched PubMed, Scopus, Google Scholar, ScienceDirect, and Web of Science databases (1980-2017) to identify randomized controlled trials or nonrandomized studies investigating the effect of COCs containing progestins with low androgenic and antiandrogenic activities, including the products containing desogestrel, cyproterone acetate, and drospirenone, on the HPG axis in patients with PCOS. In this meta-analysis, fixed and random effect models were used. Outcomes of interest were weighted mean differences (WMD) of hormonal parameters, including the follicle-stimulating hormone (FSH), luteinizing hormone (LH), LH-to-FSH ratio, estradiol, total testosterone, and sex hormone–binding globulin. Potential sources of heterogeneity were investigated using meta-regression and subgroup analyses. Subgroup analyses were performed based on the used progestin compound and treatment duration. We assessed quality of included studies and their risk of bias using Cochrane guidelines. Publication bias was assessed using Egger test and funnel plot. Results: COC use was significantly associated with a decrease in gonadotropin levels, including FSH and LH. Use of products containing cyproterone acetate was associated with a decrease in FSH levels after 3 months (WMD=−0.48; 95% CI −0.81 to −0.15), 6 months (WMD=−2.33; 95% CI −3.48 to −1.18), and 12 months (WMD=−4.70; 95% CI −4.98 to −4.42) and a decrease in LH levels after 3 months (WMD=−3.57; 95% CI −5.14 to −1.99), 6 months (WMD=−5.68; 95% CI −9.57 to −1.80), and 12 months (WMD=−11.60; 95% CI −17.60 to −5.60). Use of COCs containing drospirenone for 6 months decreased FSH (WMD=−0.93; 95% CI −1.79 to −0.08) and LH (WMD=−4.59; 95% CI −7.53 to −1.66) levels. Data for products containing desogestrel were few, but this compound generally had no statistically significant influence on gonadotropin levels similar to that observed with COCs containing cyproterone acetate and drospirenone. Use of COCs was not associated with any significant change in LH-to-FSH ratio. COCs containing cyproterone acetate showed maximum effect on gonadotropin suppression. COCs containing cyproterone acetate significantly decreased estradiol concentrations, whereas those containing drospirenone exhibited no such effect. All COCs demonstrated improvement in androgenic profile and had the same effects on total testosterone and sex hormone–binding globulin concentrations. Progestin compound and treatment duration had no statistically significant effects on changing total testosterone and sex hormone–binding globulin levels. Conclusions: COCs containing cyproterone acetate can effectively suppress gonadotropins, leading to a decrease in androgenic parameters. Although different products of COCs could significantly suppress the androgenic profile, it seems that products containing cyproterone acetate are more effective in suppressing gonadotropin and estradiol levels in patients with PCOS.

  • JMIR Res Protoc 2018;7(4):e113

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Methods and Feasibility Studies

  Apr 24, 2018

  Addressing Participant Validity in a Small Internet Health Survey (The Restore Study): Protocol and Recommendations for Survey Response Validation

  View Authors View Abstract

  Authors List:

  • James Dewitt  
  • Benjamin Capistrant  
  • Nidhi Kohli  
  • B R Simon Rosser  
  • Darryl Mitteldorf  
  • Enyinnaya Merengwa  
  • William West  

  Abstract:

  Background: While deduplication and cross-validation protocols have been recommended for large Web-based studies, protocols for survey response validation of smaller studies have not been published. Objective: This paper reports the challenges of survey validation inherent in a small Web-based health survey research. Methods: The subject population was North American, gay and bisexual, prostate cancer survivors, who represent an under-researched, hidden, difficult-to-recruit, minority-within-a-minority population. In 2015-2016, advertising on a large Web-based cancer survivor support network, using email and social media, yielded 478 completed surveys. Results: Our manual deduplication and cross-validation protocol identified 289 survey submissions (289/478, 60.4%) as likely spam, most stemming from advertising on social media. The basic components of this deduplication and validation protocol are detailed. An unexpected challenge encountered was invalid survey responses evolving across the study period. This necessitated the static detection protocol be augmented with a dynamic one. Conclusions: Five recommendations for validation of Web-based samples, especially with smaller difficult-to-recruit populations, are detailed.

  • JMIR Res Protoc 2018;7(4):e96

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Articles

  Apr 24, 2018

  An mHealth App for Decision-Making Support in Wound Dressing Selection (WounDS): Protocol for a User-Centered Feasibility Study

  View Authors View Abstract

  Authors List:

  • Scott Jordan  
  • Jane McSwiggan  
  • Joanne Parker  
  • Gayle A. Halas  
  • Marcia Friesen  

  Abstract:

  Background: Primary care health professionals, especially family physicians, see a variety of wounds, and yet—despite the frequency of providing wound care—many family physicians do not feel confident in wound care management. This is partly due to a lack of formal wound education in Family Medicine programs. While there are numerous electronic wound care resources available in the UK and North America, none were identified that address the specific need in supporting clinical decision-making in wound dressing selection. At the same time, healthcare providers are increasingly using technology in personal and professional contexts, and a logical extension is to use technology for knowledge translation strategies. Objective: This work developed a prototype mobile health software application named WounDS, designed to support clinical decision-making in selecting wound dressings. This article presents the development and evaluation plan for the WounDS app. Methods: WounDS has been developed on the iOS platform. The primary specification included ease of use, in that one of the primary influences in user adoption would be the ability to receive a wound dressing recommendation in under 30 seconds and under 5 taps on the screen. The WounDS app guides users through a series of binary decisions for assessing the wound and provides a wound dressing recommendation. The selection algorithm is based in best practices using the Wound Bed Preparation Paradigm. Results: Current work is underway to examine the implementation needs for WounDS to be most effectively utilized and to pilot test its feasibility and use in clinical care. Data will be collected through user trials, focus groups, and user metadata will be collected within the app. Optimizing these preconditions will enable a subsequent phase of study to determine effects on clinical decision-making and clinical outcomes. Conclusions: WounDS is designed for knowledge translation, use of technology in clinical decision-making, and continuity of care. The benefits of WounDS include the potential to improve healthcare providers’ competency in wound management and to improve wound healing through better alignment with evidence-based best practices in wound dressing selection, consistency in care from primary to community care, and subsequent downstream impacts in quality of life for patients.

  • JMIR Res Protoc 2018;7(4):e108

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Formative Studies and eHealth/mHealth...

  Apr 24, 2018

  Perceptions About Disseminating Health Information Among Mommy Bloggers: Quantitative Study

  View Authors View Abstract

  Authors List:

  • Amelia Burke-Garcia  
  • Gary L Kreps  
  • Kevin B Wright  

  Abstract:

  Background: Social media are potentially powerful channels for communicating relevant health information in culturally sensitive and influential ways to key audiences. Moreover, these channels hold promise for promoting awareness and knowledge of health risks, prevention, and treatment by utilizing opinion leaders for message dissemination. Despite limited empirical evidence to-date, early promising results suggest that blogs are a form of social media that should be examined as worthy channels for health communication. Objectives: This formative study explored mommy bloggers’ perceptions about sharing health-related information on their blogs with their readers. It also sought to analyze which topics would be of most interest to mommy bloggers, what motivates them to write about health issues, and how they perceive interest in these topics among their readers. Methods: This study employed survey methodology, including the use of open-ended questions, the responses to which were coded for analysis. Specifically, a 14-item survey was fielded with mommy bloggers between October 1 and October 28, 2016. Bloggers were recruited through The Motherhood network. A total of 461 mommy bloggers responded to the survey; 163 were removed for low quality responses and incomplete data. As a result, 298 eligible participants completed the survey. For open-ended questions in the survey, a sample of responses were coded and analyzed. Results: The majority of the respondents (87.2%, 260/298) reported that they have written about health issues in the past; 97.3% (290/298) of the respondents reported that they would consider writing about health issues sometime in the future, and 96.3% (287/298) of the respondents reported that their readers like to read about health issues on their blogs. In terms of content priorities for this sample of bloggers, Nutrition and Physical Activity dominate the current conversation and similarly, Physical Activity and Nutrition remain top content priorities for these bloggers for the future. Moreover, 21.3% of the respondents reported that their readers would be interested in these topics. Finally, having a personal connection with a health issue was found to be positively associated with likeliness to write about health issues on their blog (P<.001). Conclusions: This study illustrates that there are potentially rich opportunities for working with mommy bloggers to communicate with key health decision makers (moms) on important health issues. There is a great support among mommy bloggers for health information dissemination as well as interest for accessing relevant health information from their readers. This presents an opportunity for public health research and communication campaigns to more broadly promote their messages, thereby contributing to their behavior change objectives. Limitations included overrepresentation of white, higher-educated, and younger women. It suggests a need for more targeted engagement of a diverse sample for future work.

  • JMIR Res Protoc 2018;7(4):e116

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-Randomized Study Protocols and...

  Apr 23, 2018

  Identifying Subgroups of Patients With Chronic Nonspecific Low Back Pain Based on a Multifactorial Approach: Protocol For a Prospective Study

  View Authors View Abstract

  Authors List:

  • Kevin Rose-Dulcina  
  • Nicolas Vuillerme  
  • Anne Tabard-Fougère  
  • Romain Dayer  
  • Dennis E Dominguez  
  • Stephane Armand  
  • Stéphane Genevay  

  Abstract:

  Background: Low back pain, especially nonspecific chronic low back pain (LBP), the leading cause of disability worldwide, represents both social and economic problems. Different therapeutic management techniques can be used, but their effects vary. Clinicians and researchers attribute the variation in the efficacy of therapeutic and management techniques to the heterogeneity of the nonspecific chronic low back pain population, and they agree that nonspecific chronic LBP must be subgrouped. Objective: This study aims to identify nonspecific chronic LBP subgroups based on a multifactorial approach, including biomechanical, physical, and psychosocial data. Methods: A total of 100 nonspecific chronic LBP patients and 30 healthy participants aged between 18 and 60 years will be recruited for this prospective study. A psychosocial profile will be established using questionnaires on anxiety, depression, functional disability, pain, fear of pain, avoidance belief, and physical activity. A physical capacity evaluation will be conducted. It will evaluate flexibility of the hips, lumbar spine, and lateral thoracolumbar segment, as well as trunk (extensor and flexor) muscle endurance. The subjects will perform functional daily life activities, such as walking, object lifting, forward bending, sit-to-stand, stand-to-sit, balance, and usual postures. Full body kinematics, kinetics, and surface electromyography of the trunk and hip muscles will be assessed during these tasks. The clustering classification methods for the statistical analysis will be determined according to the data and will be used to identify the subgroups of nonspecific chronic LBP patients. Results: Data collection started in September 2017 and will be completed with the inclusion of all the participants (100 nonspecific chronic LBP and 30 control). The study results will be published in peer-reviewed journals and presented at relevant international conferences. Conclusions: Numerous studies have showed that the therapeutic management of nonspecific chronic LBP is difficult and has inconstant effects caused by the complexity and heterogeneity of nonspecific chronic LBP. Identifying subgroups with a multifactorial approach is more comprehensive and closer to the pathophysiology of nonspecific chronic LBP. It also represents benefit interests and a challenge both clinically and socially. The perspective of this study is expected to support clinicians for a more adapted therapeutic management for each subgroup.

  • JMIR Res Protoc 2018;7(4):e104

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-randomized Protocols and Methods...

  Apr 23, 2018

  Cultural and Contextual Adaptation of an eHealth Intervention for Youth Receiving Services for First-Episode Psychosis: Adaptation Framework and Protocol for...

  View Authors View Abstract

  Authors List:

  • Shalini Lal  
  • John Gleeson  
  • Ashok Malla  
  • Lysanne Rivard  
  • Ridha Joober  
  • Ranjith Chandrasena  
  • Mario Alvarez-Jimenez  

  Abstract:

  Background: eHealth interventions have the potential to address challenges related to access, service engagement, and continuity of care in the delivery of mental health services. However, the initial development and evaluation of such interventions can require substantive amounts of financial and human resource investments to bring them to scale. Therefore, it may be warranted to pay greater attention to policy, services, and research with respect to eHealth platforms that have the potential to be adapted for use across settings. Yet, limited attention has been placed on the methods and processes for adapting eHealth interventions to improve their applicability across cultural, geographical, and contextual boundaries. Objective: In this paper, we describe an adaptation framework and protocol to adapt an eHealth intervention designed to promote recovery and prevent relapses in youth receiving specialized services for first-episode psychosis. The Web-based platform, called Horyzons, was initially developed and tested in Australia and is now being prepared for evaluation in Canada. Methods: Service users and service providers from 2 specialized early intervention programs for first-episode psychosis located in different provinces will explore a beta-version of the eHealth intervention through focus group discussions and extended personal explorations to identify the need for, and content of contextual and cultural adaptations. An iterative consultation process will then take place with service providers and users to develop and assess platform adaptations in preparation for a pilot study with a live version of the platform. Results: Data collection was completed in August 2017, and analysis and adaptation are in process. The first results of the study will be submitted for publication in 2018 and will provide preliminary insights into the acceptability of the Web-based platform (eg, perceived use and perceived usefulness) from service provider and service user perspectives. The project will also provide knowledge about the adaptations and process needed to prepare the platform for evaluation in Canada. Conclusions: This study contributes to an important gap in the literature pertaining to the specific principles, methods, and steps involved in adapting eHealth interventions for implementation and evaluation across a diverse range of cultural, geographical, and health care settings.

  • JMIR Res Protoc 2018;7(4):e100

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-Randomized Study Protocols and...

  Apr 23, 2018

  Impact of Oral Side Effects from Conditioning Therapy Before Hematopoietic Stem Cell Transplantation: Protocol for a Multicenter Study

  View Authors View Abstract

  Authors List:

  • Michael T Brennan  
  • Bengt Hasséus  
  • Allan J Hovan  
  • Judith E Raber-Durlacher  
  • Nicole MA Blijlevens  
  • Marie-Charlotte Huysmans  
  • Karin Garming Legert  
  • Jan-Erik Johansson  
  • Charity G Moore  
  • Inger von Bültzingslöwen  

  Abstract:

  Background: The oral cavity is a common site of complications related to the cytotoxic effect of high-dose chemotherapy and radiation therapy. Considering our limited understanding of the burden of illness in the oral cavity from various cytotoxic therapies, it is difficult to produce evidence-based, preventive and management protocols. A prospective multicenter study is necessary to collect data on the burden of illness from various cytotoxic regimens. Objective: The objectives of this prospective international observational multicenter study in hematopoietic stem cell transplant (HSCT) patients are to establish the nature, incidence and temporal relationship of oral complications related to conditioning regimens (chemotherapy with or without total body irradiation), stem cell transplantation and the immunologic reactions (mainly graft-vs-host-disease) that may follow, and to determine what subjective and objective oral complications related to treatment can predict negative clinical and economic outcomes and reduced quality of life. Methods: Adult patients at six study sites receiving full intensity conditioning, reduced intensity conditioning or nonmyeloablative conditioning, followed by autologous or allogeneic hematopoietic stem cell infusion, are included. A pre-treatment assessment includes medical conditions, planned chemo- and radiation therapy regimen, medications, allergies, social history, patient report of oral problems, dental history, subjective oral complaints, objective measures of oral conditions, current laboratory values, dental treatment recommended and untreated dental disease. Starting 1-3 days after hematopoietic stem cell infusion, a bedside assessment is completed 3 days per week until resolution of neutropenia. A patient questionnaire is also completed during hospitalization. Beyond this time, patients with continued oral mucositis or other oral problems are followed 1 day per week in an inpatient or outpatient setting. Additional visits for urgent care for acute oral problems after hospitalization are documented. Autologous transplant patients are being followed up at 100 days (SD 30 days) and at 1 year (SD 30 days) post-transplantation to identify any long-term side effects. Patients treated with allogeneic transplantation are being followed at 100 days (SD 30 days), 6 months (SD 30 days), and 12 months (SD 30 days). The follow-up assessments include cancer response to therapy, current medical conditions, medications, subjective and objective oral findings, quality of life measures and laboratory values. The targeted enrollment is 254 patients who have received HSCT. Results: A total of 260 participants have been enrolled, with 233 (91%) who have received HSCT. We anticipate enrollment of 20-30 additional participants to obtain the sample size of 254 enrolled participants who have received HSCT. Conclusions: The results of the ongoing prospective study will provide a unique dataset to understand the impact of oral complications on patients undergoing HSCT and provide needed evidence for guidelines regarding the management of this patient cohort.

  • JMIR Res Protoc 2018;7(4):e103

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (eHealth)

  Apr 19, 2018

  DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial

  View Authors View Abstract

  Authors List:

  • Nathalie Jeandidier  
  • Lucy Chaillous  
  • Sylvia Franc  
  • Pierre-Yves Benhamou  
  • Pauline Schaepelynck  
  • Hélène Hanaire  
  • Bogdan Catargi  
  • Anne Farret  
  • Pierre Fontaine  
  • Bruno Guerci  
  • Yves Reznik  
  • Alfred Penfornis  
  • Sophie Borot  
  • Pierre Serusclat  
  • Yacine Kherbachi  
  • Geneviève D'Orsay  
  • Bruno Detournay  
  • Pierre Simon  
  • Guillaume Charpentier  

  Abstract:

  Background: Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Objective: Here, we present the protocol for a new study (Suivi A Grande Echelle d’une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. Methods: TELESAGE is a multicenter, double-randomized, open-label, three parallel–arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist’s task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. Results: The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. Conclusions: The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. Trial Registration: ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd)

  • JMIR Res Protoc 2018;7(4):e66

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (funded,...

  Apr 18, 2018

  A Web-Based Decision Tool to Improve Contraceptive Counseling for Women With Chronic Medical Conditions: Protocol For a Mixed Methods Implementation Study

  View Authors View Abstract

  Authors List:

  • Justine P Wu  
  • Laura J Damschroder  
  • Michael D Fetters  
  • Brian J Zikmund-Fisher  
  • Benjamin F Crabtree  
  • Shawna V Hudson  
  • Mack T Ruffin IV  
  • Juliana Fucinari  
  • Minji Kang  
  • L Susan Taichman  
  • John W Creswell  

  Abstract:

  Background: Women with chronic medical conditions, such as diabetes and hypertension, have a higher risk of pregnancy-related complications compared with women without medical conditions and should be offered contraception if desired. Although evidence based guidelines for contraceptive selection in the presence of medical conditions are available via the United States Medical Eligibility Criteria (US MEC), these guidelines are underutilized. Research also supports the use of decision tools to promote shared decision making between patients and providers during contraceptive counseling. Objective: The overall goal of the MiHealth, MiChoice project is to design and implement a theory-driven, Web-based tool that incorporates the US MEC (provider-level intervention) within the vehicle of a contraceptive decision tool for women with chronic medical conditions (patient-level intervention) in community-based primary care settings (practice-level intervention). This will be a 3-phase study that includes a predesign phase, a design phase, and a testing phase in a randomized controlled trial. This study protocol describes phase 1 and aim 1, which is to determine patient-, provider-, and practice-level factors that are relevant to the design and implementation of the contraceptive decision tool. Methods: This is a mixed methods implementation study. To customize the delivery of the US MEC in the decision tool, we selected high-priority constructs from the Consolidated Framework for Implementation Research and the Theoretical Domains Framework to drive data collection and analysis at the practice and provider level, respectively. A conceptual model that incorporates constructs from the transtheoretical model and the health beliefs model undergirds patient-level data collection and analysis and will inform customization of the decision tool for this population. We will recruit 6 community-based primary care practices and conduct quantitative surveys and semistructured qualitative interviews with women who have chronic medical conditions, their primary care providers (PCPs), and clinic staff, as well as field observations of practice activities. Quantitative survey data will be summarized with simple descriptive statistics and relationships between participant characteristics and contraceptive recommendations (for PCPs), and current contraceptive use (for patients) will be examined using Fisher exact test. We will conduct thematic analysis of qualitative data from interviews and field observations. The integration of data will occur by comparing, contrasting, and synthesizing qualitative and quantitative findings to inform the future development and implementation of the intervention. Results: We are currently enrolling practices and anticipate study completion in 15 months. Conclusions: This protocol describes the first phase of a multiphase mixed methods study to develop and implement a Web-based decision tool that is customized to meet the needs of women with chronic medical conditions in primary care settings. Study findings will promote contraceptive counseling via shared decision making and reflect evidence-based guidelines for contraceptive selection. Trial Registration: ClinicalTrials.gov NCT03153644; https://clinicaltrials.gov/ct2/show/NCT03153644 (Archived by WebCite at http://www.webcitation.org/6yUkA5lK8)

  • JMIR Res Protoc 2018;7(4):e107

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (non-eHealth)

  Apr 18, 2018

  An Exercise Intervention to Unravel the Mechanisms Underlying Insulin Resistance in a Cohort of Black South African Women: Protocol for a Randomized...

  View Authors View Abstract

  Authors List:

  • Julia H Goedecke  
  • Amy E Mendham  
  • Louise Clamp  
  • Pamela A Nono Nankam  
  • Melony C Fortuin-de Smidt  
  • Lindokuhle Phiri  
  • Lisa K Micklesfield  
  • Dheshnie Keswell  
  • Nicholas J Woudberg  
  • Sandrine Lecour  
  • Ali Alhamud  
  • Mamadou Kaba  
  • Faith M Lutomia  
  • Paul J van Jaarsveld  
  • Anniza de Villiers  
  • Steven E Kahn  
  • Elin Chorell  
  • Jon Hauksson  
  • Tommy Olsson  

  Abstract:

  Background: The pathogenesis of type 2 diabetes (T2D) in black African women is complex and differs from that in their white counterparts. However, earlier studies have been cross-sectional and provide little insight into the causal pathways. Exercise training is consistently used as a model to examine the mechanisms underlying insulin resistance and risk for T2D. Objective: The objective of the study was to examine the mechanisms underlying the changes in insulin sensitivity and secretion in response to a 12-week exercise intervention in obese black South African (SA) women. Methods: A total of 45 obese (body mass index, BMI: 30-40 kg/m2) black SA women were randomized into a control (n=22) or experimental (exercise; n=23) group. The exercise group completed 12 weeks of supervised combined aerobic and resistance training (40-60 min, 4 days/week), while the control group maintained their typical physical activity patterns, and both groups were requested not to change their dietary patterns. Before and following the 12-week intervention period, insulin sensitivity and secretion (frequently sampled intravenous glucose tolerance test) and its primary and secondary determinants were measured. Dietary intake, sleep quality and quantity, physical activity, and sedentary behaviors were measured every 4 weeks. Results: The final sample included 20 exercise and 15 control participants. Baseline sociodemographics, cardiorespiratory fitness, anthropometry, cardiometabolic risk factors, physical activity, and diet did not differ between the groups (P>.05). Conclusions: The study describes a research protocol for an exercise intervention to understand the mechanisms underlying insulin sensitivity and secretion in obese black SA women and aims to identify causal pathways underlying the high prevalence of insulin resistance and risk for T2D in black SA women, targeting specific areas for therapeutic intervention. Trial Registration: Pan African Clinical Trial Registry PACTR201711002789113; http://www.pactr.org/ATMWeb/ appmanager/atm/atmregistry?_nfpb=true&_pageLabel=portals_app_atmregistry_portal_page_13 (Archived by WebCite at http://www.webcitation.org/6xLEFqKr0)

  • JMIR Res Protoc 2018;7(4):e75

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Methods and Feasibility Studies

  Apr 17, 2018

  Capturing Ultraviolet Radiation Exposure and Physical Activity: Feasibility Study and Comparison Between Self-Reports, Mobile Apps, Dosimeters, and...

  View Authors View Abstract

  Authors List:

  • Elke Hacker  
  • Caitlin Horsham  
  • Martin Allen  
  • Andrea Nathan  
  • John Lowe  
  • Monika Janda  

  Abstract:

  Background: Skin cancer is the most prevalent cancer in Australia. Skin cancer prevention programs aim to reduce sun exposure and increase sun protection behaviors. Effectiveness is usually assessed through self-report. Objective: It was the aim of this study to test the acceptance and validity of a newly developed ultraviolet radiation (UVR) exposure app, designed to reduce the data collection burden to research participants. Physical activity data was collected because a strong focus on sun avoidance may result in unhealthy reductions in physical activity. This paper provides lessons learned from collecting data from participants using paper diaries, a mobile app, dosimeters, and accelerometers for measuring end-points of UVR exposure and physical activity. Methods: Two participant groups were recruited through social and traditional media campaigns 1) Group A—UVR Diaries and 2) Group B—Physical Activity. In Group A, nineteen participants wore an UVR dosimeter wristwatch (University of Canterbury, New Zealand) when outside for 7 days. They also recorded their sun exposure and physical activity levels using both 1) the UVR diary app and 2) a paper UVR diary. In Group B, 55 participants wore an accelerometer (Actigraph, Pensacola, FL, USA) for 14 days and completed the UVR diary app. Data from the UVR diary app were compared with UVR dosimeter wristwatch, accelerometer, and paper UVR diary data. Cohen kappa coefficient score was used to determine if there was agreement between categorical variables for different UVR data collection methods and Spearman rank correlation coefficient was used to determine agreement between continuous accelerometer data and app-collected self-report physical activity. Results: The mean age of participants in Groups A (n=19) and B (n=55) was 29.3 and 25.4 years, and 63% (12/19) and 75% (41/55) were females, respectively. Self-reported sun exposure data in the UVR app correlated highly with UVR dosimetry (κ=0.83, 95% CI 0.64-1.00, P<.001). Correlation between self-reported UVR app and accelerometer-collected moderate to vigorous physical activity data was low (ρ=0.23, P=.10), while agreement for low-intensity physical activity was significantly different (ρ=-0.49, P<.001). Seventy-nine percent of participants preferred the app over the paper diary for daily self-report of UVR exposure and physical activity. Conclusions: This feasibility study highlights self-report using an UVR app can reliably collect personal UVR exposure, but further improvements are required before the app can also be used to collect physical activity data.

  • JMIR Res Protoc 2018;7(4):e102

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Research Participants Recruitment and...

  Apr 16, 2018

  Comparison of Online Survey Recruitment Platforms for Hard-to-Reach Pregnant Smoking Populations: Feasibility Study

  View Authors View Abstract

  Authors List:

  • Jose Luis Ibarra  
  • Jessica Marie Agas  
  • Melissa Lee  
  • Julia Lily Pan  
  • Alison Meredith Buttenheim  

  Abstract:

  Background: Recruiting hard-to-reach populations for health research is challenging. Web-based platforms offer one way to recruit specific samples for research purposes, but little is known about the feasibility of online recruitment and the representativeness and comparability of samples recruited through different Web-based platforms. Objective: The objectives of this study were to determine the feasibility of recruiting a hard-to-reach population (pregnant smokers) using 4 different Web-based platforms and to compare participants recruited through each platform. Methods: A screener and survey were distributed online through Qualtrics Panel, Soapbox Sample, Reddit, and Amazon Mechanical Turk (mTurk). Descriptive statistics were used to summarize results of each recruitment platform, including eligibility yield, quality yield, income, race, age, and gestational age. Results: Of the 3847 participants screened for eligibility across all 4 Web-based platforms, 535 were eligible and 308 completed the survey. Amazon mTurk yielded the fewest completed responses (n=9), 100% (9/9) of which passed several quality metrics verifying pregnancy and smoking status. Qualtrics Panel yielded 14 completed responses, 86% (12/14) of which passed the quality screening. Soapbox Sample produced 107 completed surveys, 67% (72/107) of which were found to be quality responses. Advertising through Reddit produced the highest completion rate (n=178), but only 29.2% (52/178) of those surveys passed the quality metrics. We found significant differences in eligibility yield, quality yield, age, number of previous pregnancies, age of smoking initiation, current smokers, race, education, and income (P<.001). Conclusions: Although each platform successfully recruited pregnant smokers, results varied in quality, cost, and percentage of complete responses. Moving forward, investigators should pay careful attention to the percentage yield and cost of online recruitment platforms to maximize internal and external validity.

  • JMIR Res Protoc 2018;7(4):e101

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.