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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed- and (new!) Scopus-indexed journal, publishing peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

While the original focus was on eHealth studies, JMIR Res Protoc now publishes protocols and grant proposals in all areas of medicine, and their peer-review reports, if available (preliminary results from pilot studies, early results, and formative research should now be published in JMIR Formative Research).

While the original focus was on the design of medical and health-related research and technology innovations, JRP publishes research protocols, proposals, feasibility studies, methods and early results in all areas of medical and health research.

JMIR Res Protoc is fully open access, with full-text articles deposited in PubMed Central.

Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort.

JMIR Res Protoc is compatible with the concept of "Registered Reports" and since May 2018, published protocols receive a Registered Report Identifier (What is a Registered Report Identifier?) and acceptance of the subsequent results paper is "in principle" guaranteed in any JMIR journal and partner journals - see What is a Registered Report?. 

JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal.

JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols.

JMIR Res Protoc provides a "dry-run" for peer-review of the final results paper, and allows feedback/critique of the methods, often while they still can be fixed.

JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced.

JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods.

Studies whose protocols or grant proposals have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine.

Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others).

JMIR Res Protoc is also a unique crowdfunding platform, allowing backers to crowdfund carefully peer-reviewed projects that are not junk-science, and giving researchers additional small funding to conduct and publish their research results. Each article is published with a crowdfunding widget, allowing readers to make nominal donations to the project, which benefit the authors (currently in beta).

Need more reasons? Read the Knowledge Base article on "Why should I publish my protocol/grant proposal"!

 
 

Recent Articles:

  • The M3 (M-Cubed) app logo. Source: Image created by Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2019/11/e16439/; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (eHealth)

    Nov 15, 2019

    HIV Prevention Via Mobile Messaging for Men Who Have Sex With Men (M-Cubed): Protocol for a Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Men who have sex with men (MSM) continue to be the predominately impacted risk group in the United States HIV epidemic and are a priority group for risk reduction in national strategic goals for HIV prevention. Modeling studies have demonstrated that a comprehensive package of status-tailored HIV prevention and care interventions have the potential to substantially reduce new infections among MSM. However, uptake of basic prevention services, including HIV testing, sexually transmitted infection (STI) testing, condom distribution, condom-compatible lubricant distribution, and preexposure prophylaxis (PrEP), is suboptimal. Further, stronger public health strategies are needed to promote engagement in HIV care and viral load suppression among MSM living with HIV. Mobile health (mHealth) tools can help inform and encourage MSM regarding HIV prevention, care, and treatment, especially among men who lack access to conventional medical services. This protocol details the design and procedures of a randomized controlled trial (RCT) of a novel mHealth intervention that comprises a comprehensive HIV prevention app and brief, tailored text- and video-based messages that are systematically presented to participants based on the participants’ HIV status and level of HIV acquisition risk. Objective: The objective of the RCT was to test the efficacy of the Mobile Messaging for Men (M-Cubed, or M3) app among at least 1200 MSM in Atlanta, Detroit, and New York. The goal was to determine its ability to increase HIV testing (HIV-negative men), STI testing (all men), condom use for anal sex (all men), evaluation for PrEP eligibility, uptake of PrEP (higher risk HIV-negative men), engagement in HIV care (men living with HIV), and uptake of and adherence to antiretroviral medications (men living with HIV). A unique benefit of this approach is the HIV serostatus-inclusiveness of the intervention, which includes both HIV-negative and HIV-positive MSM. Methods: MSM were recruited through online and venue-based approaches in Atlanta, Detroit, and New York City. Men who were eligible and consented were randomized to the intervention (immediate access to the M3 app for a period of three months) or to the waitlist-control (delayed access) group. Outcomes were evaluated immediately postintervention or control period, and again three and six months after the intervention period. Main outcomes will be reported as period prevalence ratios or hazards, depending on the outcome. Where appropriate, serostatus/risk-specific outcomes will be evaluated in relevant subgroups. Men randomized to the control condition were offered the opportunity to use (and evaluate) the M3 app for a three-month period after the final RCT outcome assessment. Results: M3 enrollment began in January 2018 and concluded in November 2018. A total of 1229 MSM were enrolled. Data collection was completed in September 2019. Conclusions: This RCT of the M3 mobile app seeks to determine the effects of an HIV serostatus–inclusive intervention on the use of multiple HIV prevention and care-related outcomes among MSM. A strength of the design is that it incorporates a large sample and broad range of MSM with differing prevention needs in three cities with high prevalence of HIV among MSM. Clinical Trial: ClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247

  • Source: Flickr; Copyright: Daniel Foster; URL: http://www.flickr.com/photos/17423713@N03/23569486620; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).
    RCTs - Pilots/Feasibility Studies...

    Nov 13, 2019

    A Mobile Health App to Improve HIV Medication Adherence: Protocol for a Pilot Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Adherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence. Objective: The primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes. Methods: This study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations. Results: Phase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020. Conclusions: This study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus.

  • Source: Flickr; Copyright: Cordelia Persen; URL: https://www.flickr.com/photos/25061723@N00/2094578010; License: Creative Commons Attribution + NoDerivatives (CC-BY-ND).
    Systematic Review Protocols

    Nov 12, 2019

    Prevalence of Malnutrition Among Elderly People in Iran: Protocol for a Systematic Review and Meta-Analysis

    Authors List:

    Abstract:

    Background: Malnutrition occurs following a decrease or an imbalance in the absorption of energy, protein, vitamins, and minerals because of numerous factors. Thus, it has serious and life-threatening consequences. To plan for this issue, we need information on the burden of this problem. Objective: The aim of this study is to determine the prevalence of malnutrition among elderly people in Iran. Methods: For the purpose of this study, papers, including original articles, theses, and conference proceedings on the prevalence of malnutrition among people aged 60 years and above, and have been published in national and international journals until September 2018 will be included without any language limitation. The following keywords along with their synonyms in Persian will be used in the literature search: malnutrition, elderly, and Iran. At first, the screening process will be conducted based on our inclusion and exclusion criteria. Then, the full text of the remaining articles will be read carefully, and eligible articles will be selected according to the objectives of the study. Next, the methodological quality of the selected papers will be reviewed, and the required information will be extracted from those with acceptable quality. Finally, a meta-analysis will be performed using the Stata software (version 14) when optimum criteria are met. It should be noted that all stages of screening, selection, quality assessment of primary studies, and data extraction will be performed by two reviewers independently. Results: This review is ongoing and will be completed at the end of 2019. Conclusions: This review aims to provide comprehensive evidence about the prevalence of malnutrition among elderly people in Iran. This can help Iranian health managers and policy makers make informed decisions for preventing malnutrition and promoting the health status of elderly people. Clinical Trial: PROSPERO CRD42018115358; https://tinyurl.com/y28su47m

  • Puerperal woman with her newborn. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/11/e12970/; License: Creative Commons Attribution (CC-BY).
    Early Reports

    Nov 12, 2019

    Impact of Perinatal Different Intrauterine Environments on Child Growth and Development: Planning and Baseline Data for a Cohort Study

    Authors List:

    Abstract:

    Background: Several studies have shown that exposure of the fetus and newborn to prenatal and perinatal events, respectively, may influence the health outcomes of the child throughout their life cycle. Objective: This study aimed to increase the knowledge on the impact of different intrauterine environments on child growth and development, as we know that pregnancy and early years are a window of opportunity for health promotion and prevention interventions of diseases. Methods: The recruitment occurred 24 to 48 hours after delivery and involved mothers and their newborns in 2 public hospitals in Porto Alegre, Brazil, from December 2011 to January 2016. The mothers-newborns dyads were allocated to 5 groups: diabetes mellitus, mothers with a clinical diagnosis of diabetes; systemic arterial hypertension (SAH), mothers with a clinical diagnosis of systematic arterial hypertensive disease during pregnancy; maternal smoking, mothers who smoked at any moment of gestation; small for gestational age (SGA), mothers with SGA newborns because of intrauterine growth restriction; and control, mothers without the clinical characteristics previously mentioned. Several protocols and anthropometric measurements were applied in the interviews at immediate postpartum and 7 and 15 days and 1, 3, and 6 months after birth. For this study, we analyzed only data collected during postpartum interviews. The statistical analyses were performed using Pearson chi-square test, Mann-Whitney test, or Kruskal-Wallis test with Dunn post hoc. The significance level was set at 5%. The Hospital Ethics and Research Committees approved the study. Results: Of the 485 eligible mothers-newborns dyads, 400 agreed to participate (82.5%, 400/485). As expected, newborns from the SGA group had significantly lower birth weight, smaller stature, and lower cephalic perimeter (P<.001). This group also had the highest percentage of primiparous women in comparison with other groups (P=.005) except for control. Mothers from the SAH group had the highest mean age, the highest percentage of cesarean sections, and presented greater gestational weight gain. Conclusions: In this study, we describe the planning and structure for the systematic follow-up of mother-newborn dyads in the first 6 months after birth, considering the important demographic and epidemiological transition scenario in Brazil. The results of this prospective longitudinal study may provide a better understanding of the causal mechanisms involved in health and life course disease related to different adverse intrauterine environments.

  • Source: Adobe Stock; Copyright: Djile; URL: https://stock.adobe.com/uk/images/young-woman-doctor-takes-a-swab-from-the-throat/228914771; License: Licensed by the authors.
    Proposals (non-eHealth)

    Nov 11, 2019

    Feasibility of Point-of-Care Testing for Influenza Within a National Primary Care Sentinel Surveillance Network in England: Protocol for a Mixed Methods Study

    Authors List:

    Abstract:

    Background: Point-of-care testing (POCT) for influenza promises to provide real-time information to influence clinical decision making and improve patient outcomes. Public Health England has published a toolkit to assist implementation of these tests in the UK National Health Service. Objective: A feasibility study will be undertaken to assess the implementation of influenza POCT in primary care as part of a sentinel surveillance network. Methods: We will conduct a mixed methods study to compare the sampling rates in practices using POCT and current virology swabbing practices not using POCT, and to understand the issues and barriers to implementation of influenza POCT in primary care workflows. The study will take place between March and May 2019. It will be nested in general practices that are part of the English national sentinel surveillance network run by the Royal College of General Practitioners Research and Surveillance Centre. The primary outcome is the number of valid influenza swabs taken and tested by the practices involved in the study using the new POCT. Results: A total of 6 practices were recruited, and data collection commenced on March 11, 2019. Moreover, 312 swab samples had been collected at the time of submission of the protocol, which was 32.5% (312/960) of the expected sample size. In addition, 68 samples were positive for influenza, which was 20.1% (68/338) of the expected sample size. Conclusions: To the best of our knowledge, this is the first time an evaluation study has been undertaken on POCT for influenza in general practice in the United Kingdom. This proposed study promises to shed light on the feasibility of implementation of POCT in primary care and on the views of practitioners about the use of influenza POCT in primary care, including its impact on primary care workflows.

  • Health eNav, a digital HIV care navigation intervention. Source: Freepik; Copyright: nensuria; URL: https://www.freepik.com/free-photo/two-young-entrepreneurs-working-coffee-shop_1623538.htm#page=1&query=hispanic%20man%20with%20phone&position=49; License: Licensed by JMIR.
    Non-Randomized Studies (funded, eHealth)

    Nov 8, 2019

    Implementing a Digital HIV Care Navigation Intervention (Health eNav): Protocol for a Feasibility Study

    Authors List:

    Abstract:

    Background: Young racial and ethnic minority men who have sex with men (MSM) and trans women are disproportionately affected by HIV and AIDS in the United States. Unrecognized infection, due to a low uptake of HIV testing, and poor linkage to care are driving forces of ongoing HIV transmission among young racial and ethnic minority MSM and trans women. Internet and mobile technologies, in combination with social network-based approaches, offer great potential to overcome and address barriers to care and effectively disseminate interventions. Objective: We describe Health eNavigation (Health eNav), a digital HIV care navigation intervention that extends supportive care structures beyond clinic walls to serve youth and young adults living with HIV who are newly diagnosed, not linked to care, out of care, and not virally suppressed, at times when they need support the most. Methods: This study leverages ecological momentary assessments for a period of 90 days and uses person-delivered short message service text messages to provide participants with digital HIV care navigation over a 6-month period. We aim to improve engagement, linkage, and retention in HIV care and improve viral suppression. Digital HIV care navigation includes the following components: (1) HIV care navigation, (2) health promotion, (3) motivational interviewing, and (4) digital social support. Results: Recruitment began on November 18, 2016; enrollment closed on May 31, 2018. Intervention delivery ended on November 30, 2018, and follow-up evaluations concluded on October 31, 2019. In this paper, we present baseline sample characteristics. Conclusions: We discuss real-world strategies and challenges in delivering the digital HIV care navigation intervention in a city-level, public health setting.

  • Patient with ulcerative colitis receives vedolizumab therapy through intravenous infusion. Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/close-up-doctor-s-hand-wearing-blue-gloves-giving-syringe-patient-s-arm_3894255.htm#query=doctor%20and%20patient%20needle&position=2#position=2&query=doctor%20and%20patient%20needle; License: Licensed by JMIR.
    Non-Randomized Study Protocols and...

    Nov 8, 2019

    Monitoring of Vedolizumab Infusion Therapy (MOVE-IT) Response With Fecal Inflammation Markers, Ultrasound, and Trough Serum Level in Patients With Ulcerative...

    Authors List:

    Abstract:

    Background: Vedolizumab has been shown to induce clinical remission in patients with active ulcerative colitis. Treatment with anti-integrin vedolizumab leads to clinical remission in 16.9% and clinical response in 47.1% of cases after 6 weeks. However, in clinical practice, no decision to discontinue or continue vedolizumab therapy is made until 14 weeks at the earliest. Objective: The aim of this study is to develop an algorithm for optimizing vedolizumab administration in patients with moderate-to-severe ulcerative colitis by calculating the probability of clinical response at week 14, on the basis of the data from week 6. Methods: This is a prospective, single-arm, multicentric, noninterventional, observational study with no interim analyses and a sample size of 35 evaluable patients. Results: The enrollment started in August 2018 and was still open at the date of submission. The study is expected to complete in September 2020. Conclusions: The early identification of patients who are responding to an integrin antibody is therapeutically beneficial. At the same time, patients who are not responding can be identified earlier. The development of a therapeutic algorithm for identifying patients as responders or nonresponders can thus help prescribing physicians avoid ineffective treatments and stop these very early.

  • Source: FreeDigitalPhotos; Copyright: franky242; URL: http://www.freedigitalphotos.net/images/woman-checking-her-pulse-using-the-apple-watch-photo-p351891; License: Licensed by the authors.
    RCTs - Protocols/Proposals (eHealth)

    Nov 7, 2019

    Home-Based Cardiac Rehabilitation in Brazil’s Public Health Care: Protocol for a Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Coronary artery disease (CAD) is among the main causes of hospitalization and death worldwide, therefore, the implementation of programs to reduce its impact is necessary. Supervised cardiac rehabilitation has been shown to have positive effects on CAD control. However, there are barriers to patient participation in the traditional, face-to-face cardiac rehabilitation programs, mainly in low-resource environments. Objective: This study aimed to verify patient compliance to a home-based cardiac rehabilitation program, which includes unsupervised health education and physical exercises, guided by telephone. Moreover, we compare this new method to the traditional supervised cardiac rehabilitation offered in most hospital centers. Methods: We present here a two-arm, single-blinded, and randomized controlled design protocol, which compares the traditional cardiac rehabilitation (CenterRehab) with the home-based cardiac rehabilitation (Home-Based) in 72 patients affected by CAD. The primary outcome is the compliance to the cardiac rehabilitation sessions. The secondary outcomes (to evaluate effectiveness) include measurable variables such as functional capacity, CAD risk factors (blood pressure, waist circumference, glycemic, cholesterol levels, depressive symptoms, and the level of physical activity), the patient’s quality of life, the disease knowledge, and the morbidity rate. Parameters such as the program cost and the usability will also be evaluated. The programs will last 12 weeks, with a total of 60 rehabilitation and 6 educational sessions. Patients of the CenterRehab program will participate in 24 supervised sessions and 36 home sessions, while the patients of the Home-Based program will participate in 2 supervised sessions and 58 home sessions, guided by telephone. After the 12-week period all participants will be recommended to continue practicing physical exercises at home or at a community center, and they will be invited for re-evaluation after 3 months. The outcomes will be evaluated at baseline, and after 3 and 6 months. Results: Participants are currently being recruited for the trial. Data collection is anticipated to be completed by October 2019. Conclusions: This is the first study in Brazil comparing the traditional cardiac rehabilitation approach with a novel, home-based protocol that uses an accessible and low-cost technology. If positive results are obtained, the study will contribute to establish a new and viable model of cardiac rehabilitation. Clinical Trial: ClinicalTrials.gov NCT03605992; https://clinicaltrials.gov/ct2/show/NCT03605992

  • The Implicit Learning in Stroke trial logo. Source: Image created by Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2019/11/e14222; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (funded,...

    Nov 5, 2019

    Comparing the Impact of an Implicit Learning Approach With Standard Care on Recovery of Mobility Following Stroke: Protocol for a Pilot Cluster Randomized...

    Authors List:

    Abstract:

    Background: Although implicit and explicit learning approaches have been well investigated in healthy populations, there is less evidence regarding the relative benefits of each approach in clinical practice. Studies in stroke typically investigate single elements of an implicit learning approach (ILA; eg, reduced quantity feedback or an external focus of attention) within controlled environments. These studies predominantly evaluate performance, with few measuring this over time (ie, learning). The relevance and transferability of current research evidence into stroke rehabilitation is therefore limited. Objective: The objective of this study was to compare the ILA with standard care in the acute phase following stroke, to generate data and insights to inform the design of a definitive trial, and to understand patient and therapist perceptions of the ILA. Methods: This is a multicenter, assessor-blind, cluster randomized controlled pilot trial with nested qualitative evaluation. Stroke units (clusters) will be randomized to either ILA (intervention) or standard care (control) arms. Therapy teams at the intervention sites will be trained in the ILA and provided with an intervention manual. Those at the control sites will have minimal input from the research team, other than for data collection. Consent will be provided at the individual participant level. Once enrolled, participants will receive rehabilitation that focuses on lower limb recovery, using the designated approach. Measures will be taken at baseline, every 2 weeks until the point of discharge from hospital, and at 3 months post stroke onset. Measures include the Fugl Meyer Assessment (motor leg subsection), modified Rivermead Mobility Index, Swedish Postural Adjustment in Stroke Scale, and achievement of mobility milestones. Fidelity of the treatment approach will be monitored using observational video analysis. Focus groups and interviews will be used to gain insight into the perceptions of trial participants and clinical teams. Results: The first site opened to recruitment in February 2019. The opening of a further 5 sites will be staggered throughout 2019. Results are expected in early 2021. Conclusions: The findings from this mixed methods pilot study will be used to inform the design of a definitive study, comparing the ILA with standard care in acute stroke rehabilitation. Clinical Trial: ClinicalTrials.gov NCT03792126; https://clinicaltrials.gov/ct2/show/NCT03792126

  • Source: Image created by the Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2019/11/e14691/; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (eHealth)

    Nov 1, 2019

    The Effects of Resistance Exercise With Blood Flow Restriction on Flow-Mediated Dilation and Arterial Stiffness in Elderly People With Low Gait Speed:...

    Authors List:

    Abstract:

    Background: During aging, a significant loss of muscle mass, strength, and power is associated with a decline in daily functional capacities. Traditionally, resistance training is prescribed to prevent or reverse the skeletal muscle weakness, but the required training intensity may be too demanding for older people with poor physical performance. Resistance exercise with blood flow moderation (KAATSU training) originally developed in Japan, combines physical training with blood flow restriction. It has been reported that KAATSU training enhances muscle hypertrophy in many populations. However, few studies have evaluated the effects of resistance exercises with blood flow restriction in elderly people and how this affects vascular structure and function. Objective: This study aims to evaluate (1) the acute and chronic effects of resistance exercises with blood flow restriction on vascular health in elderly people with low gait speed and (2) whether low-load resistance training with blood flow restriction elicits similar strength and gait speed gains to those elicited by conventional resistance training without blood flow restriction. Methods: This is an ongoing randomized controlled trial in elders with low gait speed. Overall, 2 study arms of 13 participants each perform resistance exercises with and without blood flow restriction. The 2 groups are as follows: the control group will perform conventional resistance exercises (60% of 1 repetition maximum) and the KAATSU group will perform the low-load resistance exercise with blood flow restriction (20% of 1 repetition maximum) for 12 weeks. Pulse wave velocity, venous occlusion plethysmography, and flow-mediated dilation by ultrasound are used to assess arterial stiffness, muscle blood flow, and endothelial function, respectively. The secondary outcomes are gait speed, strength, and quality of life. All measures will be performed before and after the training program. Results: This research study is in progress. Recruitment has started, and data collection is expected to finish in August 2020. Conclusions: The findings of this study will have important implications on the rehabilitation treatments in the elderly population. Clinical Trial: ClinicalTrials.gov NCT03272737; https://clinicaltrials.gov/ct2/show/NCT03272737

  • Source: Pxhere; Copyright: Pxhere; URL: https://pxhere.com/en/photo/591815; License: Public Domain (CC0).
    Non-Randomized Studies (funded,...

    Oct 30, 2019

    A Salutogenic Approach to Understanding the Potential of Green Programs for the Rehabilitation of Young Employees With Burnout: Protocol for a Mixed Method...

    Authors List:

    Abstract:

    Background: Burnout is the leading cause of absenteeism in the Netherlands, with associated sick leave costs amounting to around €1.8 billion. Studies have indicated that burnout complaints increased from almost 14.4% in 2014 to 17.3% in 2018, especially among employees between the ages of 18 and 35 years, and further increases are expected. Although there are many published articles on burnout, not much is known about what constitutes effective rehabilitation (ie, the reduction of burnout complaints and the facilitation of returning to work). At the same time, multiple pilot studies have indicated that green programs are effective in both reducing burnout complaints and facilitating return to work. Green programs have been developed by professionals experienced in using the natural environment to facilitate rehabilitation (eg, through green exercise and healing gardens). The literature nevertheless lacks comprehensive and contextual insight into what works and why. Objective: The overarching aim of this study is to explore the potential of green programs for young employees with burnout. We present the study protocol from an ongoing research project consisting of 2 phases, each composed of 2 research objectives that sequentially build upon each other. Methods: The study is based on a sequential design with 4 research objectives, using both qualitative and quantitative research methods. In the first phase, a systematic literature review (research objective 1) and in-depth interviews (research objective 2) will be used to explore mechanisms underlying the rehabilitation of young employees with burnout. In the second phase, a multicase study will be conducted to examine the extent to which green programs are built on mechanisms identified in the first phase (research objective 3). By employing a pretest and posttest design, a specific green program that captures most of those mechanisms will then be evaluated on its effect and process with regard to the rehabilitation of young employees with burnout (research objective 4). The project started in June 2018 and will continue through June 2022. Results: The first phase (research objectives 1 and 2) is intended to generate information on the mechanisms underlying the rehabilitation of young employees with burnout. The second phase (research objectives 3 and 4) is designed to demonstrate the extent to which and how the selected green program facilitates the rehabilitation of young employees with burnout. Conclusions: Understanding how green programs can facilitate the rehabilitation of young employees with burnout complaints can help to address this societal issue.

  • Source: Unsplash; Copyright: Campaign Creators; URL: https://unsplash.com/photos/pypeCEaJeZY; License: Licensed by JMIR.
    Systematic Review Protocols

    Oct 28, 2019

    Visual Analytic Tools and Techniques in Population Health and Health Services Research: Protocol for a Scoping Review

    Authors List:

    Abstract:

    Background: Visual analytics (VA) promotes the understanding of data using visual, interactive techniques and using analytic and visual engines. The analytic engine includes machine learning and other automated techniques, whereas common visual outputs include flow maps and spatiotemporal hotspots for studying service gaps and disease distribution. The principal objective of this scoping review is to examine the state of science on VA and the various tools, strategies, and frameworks used in population health and health services research (HSR). Objective: The purpose of this scoping review is to develop an overarching global view of established techniques, frameworks, and methods of VA in population health and HSR. The main objectives are to explore, map, and synthesize the literature related to VA in its application to the 2 main focus areas of health care. Methods: We will use established scoping review methods to meet the study objective. As the use of the term visual analytics is inconsistent, one of the major challenges was operationalizing the concepts for developing the search strategy, based on the 3 main concepts of population health, HSR, and VA. We included peer reviewed and grey literature sources from 2005 till March 2019 in the search. Independent teams of researchers will screen the titles, abstracts and full text articles, whereas an independent researcher will arbiter conflicts. Data will be abstracted and presented using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist and explanation by 2 independent researchers. Results: As of late August 2019, the scoping review is in the full-text screening stage. Data synthesis will follow and the first results are expected to be submitted for publication in December 2019. In this protocol, the methods for undertaking this scoping review are detailed. We present how we operationalized the varied concepts of population health, health services, and VA. The main results of the scoping review will synthesize peer reviewed and grey literature sources on the main methods of VA in the interrelated fields of population health and health services research from January 2005 till March 2019. Conclusions: VA is being increasingly used and integrated with emerging technologies to support decision making using large data sets. This scoping review of the VA tools, strategies, and frameworks applied to population health and health services aims to increase awareness of this approach for uptake by decision makers working within and toward developing learning health systems globally. Clinical Trial: Not applicable.

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    Date Submitted: Oct 31, 2019

    Open Peer Review Period: Oct 31, 2019 - Dec 26, 2019

    Background: Health technology projects are typically ambitious and complex. Many fail. Greenhalgh et al’s NASSS (non-adoption, abandonment, scale-up, spread, sustainability) framework was developed...

    Background: Health technology projects are typically ambitious and complex. Many fail. Greenhalgh et al’s NASSS (non-adoption, abandonment, scale-up, spread, sustainability) framework was developed to analyse their varied fortunes. Objective: We sought to extend the NASSS framework to produce practical tools for policymakers, project planners, implementation teams and evaluators. Methods: Building on NASSS and a complexity assessment tool (CAT), the NASSS-CAT was developed (in different formats) in seven co-design workshops involving 50 stakeholders (industry executives, technical designers, policymakers, managers, clinicians, patients). Results: The co-design process resulted in four tools, available as free downloads. NASSS-CAT SHORT is a ‘taster’ to introduce the instrument and gauge interest. NASSS-CAT LONG is intended to support reflection, due diligence and preliminary planning. It invites stakeholder discussion across six domains, using free-text open questions (designed to generate a rich narrative and surface uncertainties and interdependencies) and a closed-question checklist for identifying different kinds of complexity; it also includes an action planning section. NASSS-CAT PROJECT is a 35-item instrument for monitoring how complexity in a technology implementation project changes over time. NASSS-CAT INTERVIEW is a set of prompts for conducting semi-structured research or evaluation interviews. Preliminary data from empirical case studies suggest that the NASSS-CAT tools can potentially identify, but cannot always overcome, contradictions and conflicts that block projects’ progress. Conclusions: The NASSS-CAT tools, designed to help teams understand, reduce and respond to complexity in their technology implementation projects, are a useful addition to existing tools and frameworks. They are currently being tested prospectively on a sample of case studies selected for variety in conditions, technologies, settings, scope and scale, policy context and project goals. Further support of those projects is ongoing. We plan to establish an online community of practice for people interested in using and improving the NASSS-CAT tools, and hold workshops for building cross-project collaborations. Clinical Trial: Not applicable

  • Study protocol for the development of a taxonomy of communication techniques, strategies and aids used by healthcare professionals in healthcare consultations with patients

    Date Submitted: Oct 25, 2019

    Open Peer Review Period: Oct 25, 2019 - Dec 20, 2019

    Background: Currently, there is no available standardised taxonomy of defined communication techniques and strategies used by health professionals in patient consultations. It is problematic to identi...

    Background: Currently, there is no available standardised taxonomy of defined communication techniques and strategies used by health professionals in patient consultations. It is problematic to identify communication techniques contributing to effective healthcare professional and patient consultations and to replicate communication interventions in research. Objective: The first aim of this paper is to outline a protocol for systematic review of communication techniques, strategies and aids used by healthcare professionals in patient consultations as described in the literature. The secondary aim is to describe a protocol for the development and pilot of a taxonomy of communication techniques and strategies used by health professionals in patient consultations. Methods: A systematic review will be completed to identify eligible studies. Extracted strategies and techniques will be organised into a preliminary taxonomy by a multidisciplinary team. The preliminary taxonomy will be piloted by two groups: research assistants trained in taxonomy application and health professions and health professional students not trained in taxonomy use. The pilot will use custom developed video footage of health professional and patient interactions. Results of inter-rater validity and debriefing interview feedback will be used to inform the finalisation of the preliminary taxonomy by a multidisciplinary Delphi panel. Results: N/A Conclusions: This is the first known attempt to develop a defined and standardized taxonomy of communication techniques and strategies used by health professionals in patient consultations.

  • Understanding the Uptake of Big Data in Healthcare: A Multinational Mixed-Methods Study Protocol

    Date Submitted: Oct 24, 2019

    Open Peer Review Period: Oct 24, 2019 - Dec 19, 2019

    Background: Despite the high potential of big data, its applications in healthcare face manifold organizational, social, financial, and regulatory challenges. Big data embedment in the societal dimens...

    Background: Despite the high potential of big data, its applications in healthcare face manifold organizational, social, financial, and regulatory challenges. Big data embedment in the societal dimensions of healthcare systems is underrepresented in medical research. Little is known about integrating big data applications in the corporate routines of hospitals and other care providers. Equally little is understood about embedding big data applications in daily work practices and how they lead to actual improvements for healthcare actors, such as patients, care professionals, care providers, IT companies, payers and society. Objective: This planned study aims to provide an integrated analysis of big data applications, focusing on the interrelations between concrete big data experiments, organizational routines and relevant systemic and societal dimensions. To understand the similarities and differences between interactions in various contexts, the study covers 12 big data pilot projects in eight European countries, each with its own healthcare system. Workshops will be held with stakeholders to discuss the findings, our recommendations, and their implementation. Dissemination is supported by visual representations developed to share the knowledge gained Methods: This study will utilize a mixed-methods approach that combines performance measurements, interviews, document analysis and co-creation workshops. Analysis will be structured around four key dimensions: ‘performance’, ‘embedding’, ‘legitimation’ and ‘value creation’. Data and their interrelations across the dimensions will be synthesized per application and per country. Results: The multidisciplinary focus of this study enables us to combine insights from several social sciences (health policy analysis, business administration, innovation studies, organization studies, ethics and health services research) to advance a holistic understanding of big data value realization. The multinational character enables comparative analysis across eight European countries: Austria, France, Germany, Ireland, the Netherlands, Spain, Sweden, and the United Kingdom. Given that national and organizational contexts change over time, note that it will not be possible to isolate the factors and actors that explain the implementation of the big data applications. The visual representations developed for dissemination purposes will help to reduce complexity and clarify the relations between the various dimensions. Conclusions: This study will develop an integrated approach to big data applications that considers the interrelations between concrete big data experiments, organizational routines and relevant systemic and societal dimensions. . Clinical Trial: This study is not a trial.

  • Influence of cognitive functioning on powered mobility device use: a systematic review protocol

    Date Submitted: Oct 7, 2019

    Open Peer Review Period: Oct 7, 2019 - Dec 2, 2019

    Background: Power mobility devices (PMD) are critical to achieving independent mobility and social participation for many individuals who have trouble walking. Provision of PMD is complex, with cognit...

    Background: Power mobility devices (PMD) are critical to achieving independent mobility and social participation for many individuals who have trouble walking. Provision of PMD is complex, with cognitive functioning expressed by clinicians as a major concern. Indeed, even if PMD use can be predicted by the level of cognitive functioning, outcome tools used to assess readiness do not consider how cognitive functioning may affect PMDs use. Objective: The specific aims of this review are to: (1) identify existing assessments used to assess cognitive functioning and PMD use; (2) classify, according to the International Classification of Functioning Disability and Health, cognitive functions that are identified within existing assessments related to PMD use; (3) explore the relationships between cognitive functioning (i.e., executive function, attention) and PMD use. Methods: A systematic review will be conducted using electronic databases (MEDLINE/Ovid, CINAHL, EMBASE, PsycINFO/Ovid, Web of Science) based on the concepts of PMD performance and capacity, and cognitive functioning. Inclusion criteria: 1) sample of PMD users (inclusive of age and diagnoses); 2) assessment of cognitive functioning, and 3) assessment of PMD capacity or performance. The International Classification of Functioning, Disability and Health will be used to classify cognitive functions. Study quality will be assessed using the Mixed Methods Appraisal Tool. Descriptive syntheses will be done to describe relationships between cognitive functioning and PMD use. Pearson correlation coefficients will be calculated when possible. (Funded by the Quebec Rehabilitation Research Network, approved February 2019). Results: This proposed systematic review protocol has been registered in PROSPERO (CRD42019118957). Conclusions: Results will inform the development of a PMD driving program that aims to enhance cognition. The results of this study will enhance understanding of the influence of cognitive functioning on PMD use and will support clinical practice for choosing appropriate evaluative tools. Clinical Trial: PROSPERO registration: CRD42019118957

  • Developing effective methods for eHealth personalization: protocol for the Health Telescope, a prospective interventional study

    Date Submitted: Oct 2, 2019

    Open Peer Review Period: Oct 2, 2019 - Nov 27, 2019

    Background: This protocol describes the setup of the Health Telescope: a longitudinal panel study that tracks participant activity and recommends eHealth apps to increase this activity. By setting up...

    Background: This protocol describes the setup of the Health Telescope: a longitudinal panel study that tracks participant activity and recommends eHealth apps to increase this activity. By setting up the Health Telescope, we aim to (1) understand more about the long-term use of eHealth applications, (2) measure relationships between short term and long term outcomes to investigate their relation, and (3) test different ways of personalizing eHealth application offerings. Objective: The objectives of this paper are to (1) demonstrate and motivate the validity of the choices we made while setting up the Health Telescope, (2) provide a resource for researchers interested in using Health Telescope data; and (3) act as a guideline for researchers interested in setting up their own longitudinal data collection using wearable devices. Methods: We will set up a panel consisting of 1.000 Dutch adults. Participant's physical activity, phone usage, and their mood will be assessed. A machine learning model will be used to generate personalized eHealth recommendations: our setup uniquely enables us to estimate the long term effects of these personalized eHealth offerings. Results: The data collection software has been developed and all the legal and ethical checks are in place. Recruitment is scheduled to start in Q4 of 2019. Initial results will be published Q1 of 2020. Conclusions: The aim of the Health Telescope is to investigate how different individuals respond to different ways of being encouraged to increase their physical activity. In this paper we detail the setup, methods, and analysis plan that enable us to reach this aim.

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