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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:

  • Source:; Copyright: Pixabay; URL:; License: Licensed by JMIR.

    Social Media Intervention to Promote Smoking Treatment Utilization and Cessation Among Alaska Native People Who Smoke: Protocol for the Connecting Alaska...


    Background: Despite the high prevalence of tobacco use among Alaska Native (AN) people, tobacco cessation interventions developed specifically for this group are lacking. Social media hold promise as a scalable intervention strategy to promote smoking treatment utilization and cessation, given the barriers to treatment delivery (ie, geographic remoteness, limited funding, climate, and travel costs) in the state of Alaska (AK). Building on a longstanding tobacco control research partnership with the AK Tribal Health System, in this study, we are developing and pilot-testing a culturally relevant, Facebook (FB)-delivered intervention that incorporates a digital storytelling approach adapted from the effective Centers for Disease Control Tips from Former Smokers campaign. Objective: This study aims to promote evidence-based smoking treatment (eg, state quitline and Tribal cessation programs) uptake and cessation among AN people. Methods: This study fulfills the objectives for stage 1 of the National Institute on Drug Abuse behavioral integrative treatment development program. In stage 1a, we will use a mixed method approach to develop the FB intervention. Cultural variance and surface/deep structure frameworks will address the influence of culture in designing health messages. These developmental activities will include qualitative and quantitative assessments, followed by beta testing of proposed intervention content. In stage 1b, we will conduct a randomized pilot trial enrolling 60 AN adults who smoke. We will evaluate the feasibility, uptake, consumer response, and potential efficacy of the FB intervention compared with a control condition (quitline/treatment referral only). Primary outcome measures include feasibility and biochemically verified smoking abstinence at 1-, 3-, and 6-month follow-ups. Secondary outcomes will include self-reported smoking cessation treatment utilization and abstinence from tobacco/nicotine products. We will also explore interdependence (relationship orientation and collaborative efforts in lifestyle change) as a culturally relevant mediator of intervention efficacy. Results: The study enrolled 40 participants for phase 1, with data saturation being achieved at 30 AN people who smoke and 10 stakeholders. For phase 2, we enrolled 40 participants. Qualitative assessment of proposed intervention content was completed with 30 AN smokers and 10 stakeholders. We are currently analyzing data from the quantitative assessment with 40 participants in preparation for the beta testing, followed by the randomized pilot trial. Conclusions: The project is innovative for its use of social media communication tools that are culturally relevant in a behavioral intervention designed to reach AN people statewide to promote smoking treatment utilization and cessation. The study will further advance tobacco cessation research in an underserved disparity group. If the pilot intervention is successful, we will have a blueprint to conduct a large randomized controlled efficacy trial. Our approach could be considered for other remote AN communities to enhance the reach of evidence-based tobacco cessation treatments.

  • Source: Unsplash; Copyright: Benjamin Faust; URL:; License: Licensed by JMIR.

    Action Ethnography of Community Reintegration for Veterans and Military Service Members With Traumatic Brain Injury: Protocol for a Mixed Methods Study


    Background: Numerous studies of community reintegration (CR) in traumatic brain injury (TBI) have been conducted in civilian populations, but research is limited in veteran and military service member populations. Little is known about how knowledge from civilian studies translates into veterans’ experiences and needs. The US Department of Veterans Health Administration (VHA) recognizes the distinctive health care needs of post-9/11 veteran and military service members, particularly with TBI, including the need to bridge health and rehabilitation-related services from acute care and inpatient settings to veteran and military service members’ homes and communities to facilitate CR. Objective: The goal of this study is to better understand the experiences of veterans with complicated mild, moderate, or severe TBI; their families; and CR workers as veterans and servicemembers transition to and sustain living in communities. This paper describes the rationale, design, and methods used to reach this goal. Methods: This five-year longitudinal mixed methods study uses both a community-engaged research (CEnR) approach and an ethnographic approach. The sample includes 30 veterans and service members with TBI, 13 family caregivers, 11 CR specialists, 16 key stakeholders, and 82 community events. Interviews and observations are coded and analyzed using hierarchical coding schemes and thematic analysis. Analyses include data from surveys, interviews, and participant observations. Content analysis is used to highlight the complex social context of reintegration and to triangulate quantitative data. Egocentric (personal) social network analysis is used to examine the support system a veteran or service member has in place to facilitate reintegration. Results: Study enrollment and data collection are completed. Data analyses are underway. Conclusions: The results of this study may provide a heightened understanding of environmental factors affecting CR in complicated mild, moderate, or severe TBI. Veteran, servicemember and family voices and insights provide VHA clinicians and policy makers with an ecological view of CR that is grounded in the life experiences of veterans, military service members, and families. The results of this study provide a roadmap for designing and testing interventions to maximize CR in a variety of domains. The longitudinal ethnographic approach allows for capturing detailed experiences within the naturalistic context. CEnR allows collaborative assessment of the social context of reintegration with community members.

  • A wearable device (Withings Steel) to send data to the Way to Health technology platform. Source: Flickr; Copyright: Matt Gibson; URL:; License: Creative Commons Attribution + Noncommercial (CC-BY-NC).

    Remotely Monitored Gamification and Social Incentives to Improve Glycemic Control Among Adults With Uncontrolled Type 2 Diabetes (iDiabetes): Protocol for a...


    Background: Type 2 diabetes is a significant cause of morbidity and mortality in the United States. Lifestyle modifications including increasing physical activity and losing weight have been demonstrated to improve glycemic control. However, most patients struggle to make these changes. Many stakeholders are interested in using gamification and social incentives to increase engagement in healthy behaviors. However, these approaches often do not appropriately leverage insights from behavioral economics that could be used to address predictable barriers to behavior change. Objective: This study aimed to describe the protocol for the Influencing DIabetics to Adapt Behaviors related to Exercise and weighT by Enhancing Social incentives (iDiabetes) trial, which aimed to evaluate the effectiveness of gamification interventions that leverage insights from behavioral economics to enhance supportive, competitive, or collaborative social incentives to improve glycemic control, promote weight loss, and increase physical activity among overweight and obese adults with type 2 diabetes. Methods: We are conducting a one-year four-arm randomized controlled trial of 361 overweight and obese patients with type 2 diabetes and a glycated hemoglobin (HbA1c) level ≥8.0. Wireless weight scales and wearable devices are provided to remotely monitor weight and physical activity and transmit data to the study team. Patients are recruited by email, following which they establish a baseline measure of weight, daily step count, HbA1c level, and low-density lipoprotein cholesterol level and then repeat these measures at 6 and 12 months. The control arm receives no other interventions. Patients randomized to one of the three intervention arms are entered into a game designed using insights from behavioral economics to enhance supportive, competitive, or collaborative social incentives. To examine predictors of strong or poor performance, participants completed validated questionnaires on a range of areas including their personality, risk preferences, and social network. Results: Enrollment of 361 patients was completed in January 2019. Results are expected in 2020. Conclusions: The iDiabetes trial represents a scalable model to remotely monitor the daily health behaviors of adults with type 2 diabetes. Results from this trial will help provide insights into how to improve management of patients with type 2 diabetes. Clinical Trial: NCT02961192;

  • The OPEN project logo. Source: Image created by the Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution + Noncommercial (CC-BY-NC).

    Evidence on User-Led Innovation in Diabetes Technology (The OPEN Project): Protocol for a Mixed Methods Study


    Background: Digital innovations in health care have traditionally followed a top-down pathway, with manufacturers leading the design and production of technology-enabled solutions and those living with chronic conditions involved only as passive recipients of the end product. However, user-driven open-source initiatives in health care are becoming increasingly popular. An example is the growing movement of people with diabetes, who create their own “Do-It-Yourself Artificial Pancreas Systems” (DIYAPS). Objective: The overall aim of this study is to establish the empirical evidence base for the clinical effectiveness and quality-of-life benefits of DIYAPS and identify the challenges and possible solutions to enable their wider diffusion. Methods: A research program comprising 5 work packages will examine the outcomes and potential for scaling up DIYAPS solutions. Quantitative and qualitative methodologies will be used to examine clinical and self-reported outcome measures of DIYAPS users. The majority of members of the research team live with type 1 diabetes and are active DIYAPS users, making Outcomes of Patients’ Evidence With Novel, Do-It-Yourself Artificial Pancreas Technology (OPEN) a unique, user-driven research project. Results: This project has received funding from the European Commission’s Horizon 2020 Research and Innovation Program, under the Marie Skłodowska-Curie Action Research and Innovation Staff Exchange. Researchers with both academic and nonacademic backgrounds have been recruited to formulate research questions, drive the research process, and disseminate ongoing findings back to the DIYAPS community and other stakeholders. Conclusions: The OPEN project is unique in that it is a truly patient- and user-led research project, which brings together an international, interdisciplinary, and intersectoral research group, comprising health care professionals, technical developers, biomedical and social scientists, the majority of whom are also living with diabetes. Thus, it directly addresses the core research and user needs of the DIYAPS movement. As a new model of cooperation, it will highlight how researchers in academia, industry, and the patient community can create patient-centric innovation and reduce disease burden together.

  • The Medical Monitoring Project logo. Source: Image created by the Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

    A National Behavioral and Clinical Surveillance System of Adults With Diagnosed HIV (The Medical Monitoring Project): Protocol for an Annual Cross-Sectional...


    Background: The Medical Monitoring Project (MMP) is a national population-based behavioral and clinical surveillance system of adults with diagnosed HIV in the United States, and it is sponsored by the Centers for Disease Control and Prevention (CDC). Its purpose is to provide locally and nationally representative estimates of factors affecting HIV transmission risk and clinical outcomes. Objective: This study aimed to describe the rationale for and methodology of the MMP, in addition to its contribution to evaluating and monitoring HIV prevention, care, and treatment efforts in the United States. Methods: MMP employs a stratified 2-stage sample design to select annual samples of persons living with diagnosed HIV from the National HIV Surveillance System and conducts interviews and medical record abstractions with participating persons. Results: MMP data are published routinely via annual reports, conference presentations, and scientific publications. Data may be accessed upon request from the CDC, contingent on the guidelines established for the security and confidentiality of HIV surveillance data. Conclusions: MMP is the only source of annual population-based data on the behaviors and clinical care of persons with diagnosed HIV in the United States. It provides essential information for monitoring progress toward national treatment and prevention goals and guiding efforts to improve the health of persons with diagnosed HIV and prevent HIV transmission.

  • Source: Unsplash; Copyright: Providence Doucet; URL:; License: Licensed by JMIR.

    Nutritional Assessment of Childhood Cancer Survivors (the Swiss Childhood Cancer Survivor Study-Nutrition): Protocol for a Multicenter Observational Study


    Background: Childhood cancer survivors are at high risk of developing adverse late health effects. Poor nutritional intake may contribute to this risk, but information about dietary intake is limited. Objective: This study will assess childhood cancer survivors’ dietary intake and compare two dietary assessment tools: a self-reported food frequency questionnaire, and dietary measurements from urine spot samples. Methods: In a substudy of the Swiss Childhood Cancer Survivor Study (SCCSS), SCCSS-Nutrition, we assessed childhood cancer survivors’ dietary intake via a validated food frequency questionnaire. We sent a urine spot collection kit to a subset of 212 childhood cancer survivors from the French-speaking region of Switzerland to analyze urinary sodium, potassium, urea, urate, creatinine, and phosphate content. We will compare the food frequency questionnaire results with the urine spot analyses to quantify childhood cancer survivors’ intake of various nutrients. We collected data between March 2016 and March 2018. Results: We contacted 1599 childhood cancer survivors, of whom 919 (57.47%) returned a food frequency questionnaire. We excluded 11 childhood cancer survivors who were pregnant or were breastfeeding, 35 with missing dietary data, and 71 who had unreliable food frequency questionnaire data, resulting in 802 childhood cancer survivors available for food frequency questionnaire analyses. To a subset of 212 childhood cancer survivors in French-speaking Switzerland we sent a urine spot collection kit, and 111 (52.4%) returned a urine sample. We expect to have the results from analyses of these samples in mid-2019. Conclusions: The SCCSS-Nutrition study has collected in-depth dietary data that will allow us to assess dietary intake and quality and compare two dietary assessment tools. This study will contribute to the knowledge of nutrition among childhood cancer survivors and is a step toward surveillance guidelines and targeted nutritional recommendations for childhood cancer survivors in Switzerland. Clinical Trial: NCT03297034;

  • Source: Pixabay; Copyright: Mircea Iancu; URL:; License: Licensed by JMIR.

    Real-Time Detection of Behavioral Anomalies of Older People Using Artificial Intelligence (The 3-PEGASE Study): Protocol for a Real-Life Prospective Trial


    Background: Most frail older persons are living at home, and we face difficulties in achieving seamless monitoring to detect adverse health changes. Even more important, this lack of follow-up could have a negative impact on the living choices made by older individuals and their care partners. People could give up their homes for the more reassuring environment of a medicalized living facility. We have developed a low-cost unobtrusive sensor-based solution to trigger automatic alerts in case of an acute event or subtle changes over time. It could facilitate older adults’ follow-up in their own homes, and thus support independent living. Objective: The primary objective of this prospective open-label study is to evaluate the relevance of the automatic alerts generated by our artificial intelligence–driven monitoring solution as judged by the recipients: older adults, caregivers, and professional support workers. The secondary objective is to evaluate its ability to detect subtle functional and cognitive decline and major medical events. Methods: The primary outcome will be evaluated for each successive 2-month follow-up period to estimate the progression of our learning algorithm performance over time. In total, 25 frail or disabled participants, aged 75 years and above and living alone in their own homes, will be enrolled for a 6-month follow-up period. Results: The first phase with 5 participants for a 4-month feasibility period has been completed and the expected completion date for the second phase of the study (20 participants for 6 months) is July 2020. Conclusions: The originality of our real-life project lies in the choice of the primary outcome and in our user-centered evaluation. We will evaluate the relevance of the alerts and the algorithm performance over time according to the end users. The first-line recipients of the information are the older adults and their care partners rather than health care professionals. Despite the fast pace of electronic health devices development, few studies have addressed the specific everyday needs of older adults and their families. Clinical Trial: NCT03484156;

  • The M3 (M-Cubed) app logo. Source: Image created by Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

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


    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: NCT03666247;

  • Source: Flickr; Copyright: Daniel Foster; URL:; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).

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


    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:; License: Creative Commons Attribution + NoDerivatives (CC-BY-ND).

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


    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;

  • Puerperal woman with her newborn. Source: Image created by the Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

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


    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:; License: Licensed by the authors.

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


    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.

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    Date Submitted: Nov 15, 2019

    Open Peer Review Period: Nov 15, 2019 - Jan 10, 2020

    Background: Hepatocellular carcinoma (HCC) is a worldwide health concern because its incidence continues to increase globally; moreover, the prognosis for patients with HCC remains poor. Transarterial...

    Background: Hepatocellular carcinoma (HCC) is a worldwide health concern because its incidence continues to increase globally; moreover, the prognosis for patients with HCC remains poor. Transarterial chemoembolization (TACE) has been established as the standard of care for intermediate stage of HCC; however, recurrence occurs at a high rate and no agents are available to suppress this. Objective: To evaluate the safety of AFP-derived peptides for patients with HCC after TACE. Methods: This will be an open-label, single arm, multicenter study to evaluate the safety of α-fetoprotein (AFP)-derived peptides (AFP 357 and AFP 403), which contain HLA-A24-restricted CTL epitopes from tumor antigens expressed in HCC and recognized by lymphocytes in HCC patients at a high rate. Protocol treatment will consist of six courses of the subcutaneous administration of 3 mg each of AFP 357 and AFP 403. A total of 14 patients will be included in this study, the first six as a main analysis target group and eight as an extended cohort from three institutions in Japan. The primary endpoint will be the occurrence of serious adverse events (safety profile). The secondary endpoints will include time to progression, overall survival, completion rate, and adverse events. Results: We will recruit 14 HCC patients until December, 2019. We will complete the final follow-up by March, 2020. Conclusions: In this study, we will evaluate the safety profile of AFP-derived peptides for patients with HCC after TACE. We believe that this study will provide useful information and will lead to the design of a subsequent phase II trial based on the results. Clinical Trial: Japan Registry of Clinical Trials (jRCTs041180155).

  • The NASSS-CAT tools for supporting technology projects in health and social care: co-design of tools and protocol for further testing

    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

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    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.