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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: Image created by the authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/2/e16448/; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).
    Non-Randomized Studies (funded,...

    Feb 28, 2020

    Improving Exposure Assessment Methodologies for Epidemiological Studies on Pesticides: Study Protocol

    Authors List:

    Abstract:

    Background: Exposure to certain pesticides has been associated with several chronic diseases. However, to determine the role of pesticides in the causation of such diseases, an assessment of historical exposures is required. Exposure measurement data are rarely available; therefore, assessment of historical exposures is frequently based on surrogate self-reported information, which has inherent limitations. Understanding the performance of the applied surrogate measures in the exposure assessment of pesticides is therefore important to allow proper evaluation of the risks. Objective: The Improving Exposure Assessment Methodologies for Epidemiological Studies on Pesticides (IMPRESS) project aims to assess the reliability and external validity of the surrogate measures used to assign exposure within individuals or groups of individuals, which are frequently based on self-reported data on exposure determinants. IMPRESS will also evaluate the size of recall bias on the misclassification of exposure to pesticides; this in turn will affect epidemiological estimates of the effect of pesticides on human health. Methods: The IMPRESS project will recruit existing cohort participants from previous and ongoing research studies primarily of epidemiological origin from Malaysia, Uganda, and the United Kingdom. Consenting participants of each cohort will be reinterviewed using an amended version of the original questionnaire addressing pesticide use characteristics administered to that cohort. The format and relevant questions will be retained but some extraneous questions from the original (eg, relating to health) will be excluded for ethical and practical reasons. The reliability of pesticide exposure recall over different time periods (<2 years, 6-12 years, and >15 years) will then be evaluated. Where the original cohort study is still ongoing, participants will also be asked if they wish to take part in a new exposure biomonitoring survey, which involves them providing urine samples for pesticide metabolite analysis and completing questionnaire information regarding their work activities at the time of sampling. The participant’s level of exposure to pesticides will be determined by analyzing the collected urine samples for selected pesticide metabolites. The biomonitoring measurement results will be used to assess the performance of algorithm-based exposure assessment methods used in epidemiological studies to estimate individual exposures during application and re-entry work. Results: The project was funded in September 2017. Enrollment and sample collection was completed for Malaysia in 2019 and is on-going for Uganda and the United Kingdom. Sample and data analysis will proceed in 2020 and the first results are expected to be submitted for publication in 2021. Conclusions: The study will evaluate the consistency of questionnaire data and accuracy of current algorithms in assessing pesticide exposures. It will indicate where amendments can be made to better capture exposure data for future epidemiology studies and thus improve the reliability of exposure-disease associations.

  • This photo was taken during the educational intervention program for new international postgraduate students. Source: Image created by the authors; Copyright: Musheer Abdulwahid Aljaberi; URL: http://www.researchprotocols.org/2020/2/e12950/; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (funded,...

    Feb 27, 2020

    Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol...

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    Abstract:

    Background: Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. Objective: This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. Methods: A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. Results: The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as P<.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. Conclusions: We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. Trial Registration: Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;EncHid=&amp;userName=Muhamad%20Hanafiah%20Juni

  • Source: The Authors / Placeit; Copyright: JMIR Publications; URL: https://www.researchprotocols.org/2020/2/e16294; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (funded,...

    Feb 24, 2020

    A Web-Based Human Papillomavirus Vaccination Intervention for Young Gay, Bisexual, and Other Men Who Have Sex With Men: Protocol for a Randomized Controlled...

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    Abstract:

    Background: Gay, bisexual, and other men who have sex with men experience several disparities related to human papillomavirus (HPV) infection, including high incidence rates of anal cancer. Although the HPV vaccine is currently recommended for young adults, HPV vaccine coverage is modest among young gay, bisexual, and other men who have sex with men (YGBMSM). Objective: We describe the design and methods for a randomized controlled trial (RCT) to rigorously evaluate Outsmart HPV, a population-targeted, individually tailored, Web-based HPV vaccination intervention for YGBMSM. The RCT is designed to determine the efficacy of the intervention, the mechanism by which the intervention has an effect (ie, mediation), and whether efficacy varies by participant characteristics (ie, moderation). Methods: Outsmart HPV was previously developed and pilot-tested. This study is a 3-arm prospective RCT that will enroll a projected 1995 YGBMSM who are aged 18 to 25 years, live in the United States, and have not received any doses of the HPV vaccine. Participants will be recruited by means of paid advertisements on social media sites and randomized to receive (1) standard information on the Web about HPV vaccine (control group), (2) Outsmart HPV content on the Web with monthly unidirectional vaccination reminders sent via text messages, or (3) Outsmart HPV content on the Web with monthly interactive vaccination reminders sent via text messages. Participants will complete Web-based surveys at 4 time points during the study: baseline, immediately after engaging with Web-based content, 3 months after randomization, and 9 months after randomization. Primary outcomes will include both HPV vaccine initiation (ie, receipt of 1 or more doses of the HPV vaccine) and completion (receipt of all 3 doses recommended for this age range). We will examine constructs from the intervention’s theoretical framework as potential mediators and demographic and health-related characteristics as potential moderators of intervention effects. Results: The institutional review board at The Ohio State University has approved the study. Materials have been developed and finalized for all study groups. Recruitment for the RCT began in fall 2019. Conclusions: If shown to be efficacious, Outsmart HPV has the potential to fill an important gap by promoting HPV vaccination among a population at increased risk of HPV infection and HPV-related disease. Trial Registration: ClinicalTrials.gov NCT04032106; http://clinicaltrials.gov/show/NCT04032106

  • Source: Image created by the Authors; Copyright: FDI World Dental Federation / the Authors; URL: http://www.researchprotocols.org/2020/2/e14156/; License: Licensed by the authors.
    RCTs - Protocols/Proposals (non-eHealth)

    Feb 21, 2020

    A 21-Day School-Based Toothbrushing Intervention in Children Aged 6 to 9 Years in Indonesia and Nigeria: Protocol for a Two-Arm Superiority Randomized...

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    Abstract:

    Background: The World Health Organization reports that dental cavities affect 60% to 90% of children globally. FDI World Dental Federation and Unilever Oral Care have developed public health programs to improve brushing habits over their 12-year partnership. The last of these (phase III) named Brush Day & Night aimed to educate children on brushing twice daily with a fluoride toothpaste and gave useful information for a new project, phase IV. The 21-day Brush Day & Night program is an intense education activity designed to establish the habit of brushing day and night with a fluoride toothpaste. The program involves daily brushing instruction and includes free toothpaste and toothbrushes. Objective: The main objective of the study is to evaluate the impact of a 21-day school program on children’s oral health. As a secondary objective, we aim to evaluate the impact on the knowledge, behavior, toothbrushing habits, and quality of life in school children aged 6 to 9 years after a 21-day school program and compare with baseline and a control group as measured by the self-reported questionnaires issued to children (in particular, the self-reported brushing frequency and positive responses on fluoridated toothpaste use). The enduring nature of the program will be determined by the inclusion of 8- and 24-week time points. Methods: The study is a 2-arm superiority randomized controlled trial. Clusters in this study are infant and junior schools in Indonesia and Nigeria. The study aims to recruit 20 schools with children aged 6 to 9 years in each country. At baseline, children in both intervention and control schools will answer a questionnaire and have their clinical oral health assessed using the Simplified Oral Hygiene Index (OHI) and Decayed Missing and Filled Teeth index. Children in the intervention schools will then take part in a structured 21-day Brush Day & Night intervention. Children in the control schools will be provided with free toothpaste and toothbrushes but will not receive the 21-day intervention. The questionnaires and OHI assessments are repeated after the 21-day program is completed and again 8 weeks later and 24 weeks later for all participating children. Parents/carers/guardians of all children will sign the informed consent and complete questionnaires on their own experience and attitudes toward oral health and toothbrushing routine at each of the four times points (baseline, 21 days, 8 weeks, and 24 weeks). The study will be conducted by the national dental associations of Indonesia and Nigeria and was approved by the ethics committees of both countries. Results: The study is ongoing. Recruitment of schools started in Indonesia in February 2018 and in Nigeria in April 2018 for the first part of the study, which concluded in Indonesia in September 2018 and in Nigeria in November 2018. The second part of the study (the second half of the schools) started in November 2018 in Indonesia and December 2018 in Nigeria. Conclusions: We expect to collect all the data during 2019 and publish findings from the study by March 2020. Trial Registration: ClinicalTrials.gov NCT04001296; https://tinyurl.com/selxraa

  • Source: The Authors / Placeit; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2020/2/e16231/; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (eHealth)

    Feb 21, 2020

    A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial

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    Abstract:

    Background: HealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low. Objective: The aim of this study will be to assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States. Methods: In this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription. Results: Participant recruitment began in January 2020. Conclusions: This trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States. Trial Registration: ClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942

  • Source: Freepik; Copyright: Rawpixel.com; URL: https://www.freepik.com/free-photo/african-man-using-mobile-phone_2975954.htm#page=6&query=african+american+smartphone&position=31; License: Licensed by the authors.
    RCTs - Protocols/Proposals (funded,...

    Feb 20, 2020

    A Mobile Intervention to Improve Uptake of Pre-Exposure Prophylaxis for Southern Black Men Who Have Sex With Men: Protocol for Intervention Development and...

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    Abstract:

    Background: The uptake of pre-exposure prophylaxis (PrEP) has been slow for young black men who have sex with men (BMSM) living in the southern United States. This is a significant issue because 8 of the 10 states with the highest rates of new HIV infections are in the South. Jackson, Mississippi (MS), the site of this project, has the second highest AIDS diagnosis rate in the nation and the highest rate of HIV infection for young, urban BMSM. This study will develop and test an engaging, interactive, and cost-effective mobile messaging intervention to improve engagement in PrEP care for BMSM aged 18 to 35 years living in Jackson, MS. Objective: The goals of this mixed methods study are to (1) conduct qualitative interviews with young BMSM in Jackson, MS, to understand individual, community, and structural barriers affecting engagement in PrEP-related care, (2) assemble a PrEP mobile messaging intervention that includes text messages with publicly available internet content (websites and YouTube videos) that provide factual information, motivational materials, and behavioral skills related to PrEP and HIV prevention, and (3) evaluate the preliminary efficacy of the intervention in a randomized controlled study with PrEP-eligible BMSM receiving care in STI/HIV testing clinics in Jackson, MS. Methods: This research protocol will be conducted in 2 phases. A development phase will involve in-depth interviews (n=30) with PrEP-eligible BMSM who receive care in STI/HIV testing clinics in MS. These interviews will allow researchers to select the texted material that will be sent out during the intervention. The second phase will consist of an unblinded, small, randomized controlled trial among 66 new participants to examine the preliminary efficacy of the intervention compared with enhanced standard of care (ESC) on attendance at a PrEP services appointment (the first step in initiating PrEP care) and receipt of a PrEP prescription, based on self-report and electronic medical records. The free, publicly available material will be sent to PrEP-eligible BMSM in 8 to 16 interactive text messages over 4 weeks. Study assessments will occur at enrollment and at 4- and 16-weeks postenrollment and can be completed online or in person. All participants will be recruited from a local clinic. Results: Institutional review board approval was received on January 16, 2017, and research activities, subsequently, began in February 2018. Recruitment for the study concluded in November 2019. In total, 65 participants were randomized with 33 being assigned to the intervention and 32 to ESC. Collection of follow-up data is ongoing. Conclusions: This PrEP mobile messaging intervention aims to increase uptake of PrEP by BMSM in the southern United States. This intervention uses interactive, tailored text messaging and appealing free Web content (publicly accessible educational websites and YouTube videos) to promote linkage to PrEP care and increase HIV preventative behaviors. A cost-effective PrEP mobile messaging intervention has great potential to improve information about PrEP, improve motivation to use PrEP, and decrease stigma and structural barriers that often prevent engagement in PrEP-related medical care. Trial Registration: ClinicalTrials.gov NCT03308097; https://clinicaltrials.gov/ct2/show/NCT03308097

  • Elderly man using the smartphone app that is part of the intervention (montage). Source: The Authors / Placeit; Copyright: The Authors; URL: https://www.researchprotocols.org/2020/2/e15105; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (eHealth)

    Feb 19, 2020

    A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial

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    Abstract:

    Background: Telemedicine based on self-measurement of disease activity could be one of the key components to create the health care system of the future. Previous publications in various medical fields have shown that it is possible to safely telemonitor patients while reducing the number of outpatient clinic visits. For this purpose, we developed a mobile phone app for patients with rheumatoid arthritis (RA), which allows them to self-monitor their disease. Objective: The objective of this study is to assess the safety and efficacy of self-initiated care assisted by a smartphone app in patients with RA. Methods: This is a randomized controlled trial that will be performed for 1 year. A total of 176 patients with RA will be randomized to either self-initiated care with only one scheduled follow-up consultation assisted by our app or usual care. The coprimary outcome measures are the number of outpatient clinic consultations with a rheumatologist taking place during the trial period and the mean disease activity score as measured by the disease activity score 28 (DAS28) at 12 months. The secondary outcomes are patient satisfaction, adherence, patient empowerment, and cost evaluation of health care assisted by the app. Results: Recruitment started in May 2019, and up to 18 months will be required for completion of recruitment. Thus far, 78 patients have been randomized, and thus far, experiences with the app have been positive. The study results are expected to be published by the end of 2021. Conclusions: The completion of this study will provide important data regarding the following: (1) safety of self-initiated care supported by a smartphone app in terms of DAS28 and (2) efficacy of lowering health care usage with this new strategy of providing health care. Trial Registration: Netherlands Trial Register NL7715; https://www.trialregister.nl/trial/7715

  • Woman standing near man while carrying smartphone. Source: Pexels; Copyright: mentatdgt; URL: https://www.pexels.com/photo/woman-standing-near-man-while-carrying-smartphone-1186886/; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (eHealth)

    Feb 18, 2020

    Text Message Behavioral Intervention for Teens on Eating, Physical Activity and Social Wellbeing (TEXTBITES): Protocol for a Randomized Controlled Trial

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    Abstract:

    Background: Obesity is among the most significant health challenges facing today’s adolescents. Weight gain during adolescence is related to cardiovascular disease, type 2 diabetes, and some cancers in later life. Presently, adolescents living in Australia have limited access to age-appropriate obesity prevention services. Objective: This study aims to investigate whether a two-way text message program, with optional telephone health counseling, improves body mass index (BMI) z score and lifestyle outcomes in adolescents who are overweight. Methods: This study will be a single-blind randomized controlled trial (N=150) comparing a two-way text message intervention, with optional telephone health counseling, to usual care in adolescents (13-18 years old, inclusive) who are overweight (recruited from a pediatric weight management clinic and the broader community in Sydney, Australia). The intervention group will receive a six-month text message program, which consists of two-way, semipersonalized, lifestyle-focused text messages (four messages/week) in addition to usual care. The control group will be assigned to receive usual care. The study also includes a follow-up at 12-months. The primary outcome is a change in BMI z score at six months. Secondary outcomes are changes in waist-to-height ratio, diet, physical and sedentary activity levels, sleep quality, quality of life, self-esteem, self-efficacy, social support, and eating disorder and depression symptoms. Also, we will examine acceptability, utility, and engagement with the program through a study-specific process evaluation questionnaire, semi-structured telephone interviews, and an analysis of health counselor communication logs. The analyses will be performed by the intention-to-treat principle to assess differences between intervention and control groups. Results: The study opened for recruitment in December 2019. Data collection is expected to be completed by December 2021, and the results for the primary outcome are expected to be published in early 2022. Conclusions: This study will test the effectiveness of an interactive two-way text message program compared to usual care in improving BMI z score and lifestyle outcomes in adolescents with overweight. This interactive, innovative, and scalable project also aims to inform future practice and community initiatives to promote obesity prevention behaviors for adolescents. Clinical Trial: Australia New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619000389101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377158&isReview=true

  • Source: Shopify; Copyright: Nicole De Khors; URL: https://burst.shopify.com/photos/nurse-helping-patient?q=nurse; License: Creative Commons Attribution (CC-BY).
    Non-randomized Protocols and Methods...

    Feb 18, 2020

    Nonclinical Sexual Health Support for HIV, Viral Hepatitis, and Other Sexually Transmitted Infections in Gay, Bisexual, and Other Men Who Have Sex With Men:...

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    Abstract:

    Background: The term “community health worker” (CHW) can apply to a wide range of individuals providing health services and support for diverse populations. Very little is known about the role of CHWs in Europe working in nonclinical settings who promote sexual health and prevent HIV and other sexually transmitted infections (STIs) among gay, bisexual, and other men who have sex with men (MSM). Objective: This paper describes the development and piloting of the first European Community Health Worker Online Survey (ECHOES) as part of the broader European Union-funded ESTICOM (European Surveys and Trainings to Improve MSM Community Health) project. The questionnaire aimed to assess the knowledge, attitudes, and practices of CHWs providing sexual health services to gay, bisexual, and other MSM in European settings. Methods: ECHOES comprises three superordinate domains divided into 10 subsections with 175 items (routed) based on a scoping exercise and literature review, online prepiloting, and Europe-wide consultation. Additional piloting and cognitive debriefing interviews with stakeholders were conducted to identify comprehension issues and improve the clarity, intelligibility, accessibility, and acceptability of the survey. Psychometric properties, including internal consistency of the standardized scales used as part of the survey were examined. The final survey was available to 33 countries in 16 languages. Results: Recruitment closed on January 31, 2018. Data from 1035 CHWs were available for analysis after application of the exclusion criteria. The findings of the ECHOES survey and the wider ESTICOM project, are now available from the ESTICOM website and/or by contacting the first author. Conclusions: The findings of this survey will help characterize, for the first time, the diverse role of CHWs who provide sexual health services to gay, bisexual, and other MSM in Europe. Importantly, the data will be used to inform the content and design of a dedicated training program for CHWs as part of the larger ESTICOM project and provide recommendations for MSM-specific strategies to improve sexual health in general and to reduce the incidence and prevalence of HIV, viral hepatitis, and other STIs in particular.

  • Source: FlickR; Copyright: a b; URL: http://www.flickr.com/photos/29411446@N08/44136407264; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).
    Non-randomized Protocols and Methods...

    Feb 14, 2020

    Preferences for Sun Protection With a Self-Monitoring App: Protocol of a Discrete Choice Experiment Study

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    Abstract:

    Background: The incidence of sun-exposure-related skin conditions, such as melanoma, is a gradually increasing and largely preventable public health problem. Simultaneously, the availability of mobile apps that enable the self-monitoring of health behavior and outcomes is ever increasing. Inevitably, recent years have seen an emerging volume of electronic patient-generated health data (PGHD), as well as their targeted application across primary prevention areas, including sun protection and skin health. Despite their preventive potential, the actual impact of these apps relies on the engagement of health care consumers, who are primarily responsible for recording, sharing, and using their PGHD. Exploring preferences is a key step toward facilitating consumer engagement and ultimately realizing their potential. Objective: This paper describes an ongoing research project that aims to elicit the preferences of health care consumers for sun protection via app-based self-monitoring. Methods: A discrete choice experiment (DCE) will be conducted to explore how healthy consumers choose between two alternative preventive self-monitoring apps. DCE development and attribute selection were built on extensive qualitative work, consisting of the secondary use of a previously conducted scoping review, a rapid review of reviews, 13 expert interviews, and 12 health care consumer interviews, the results of which are reported in this paper. Following D-optimality criteria, a fractional factorial survey design was generated. The final DCE will be administered in the waiting room of a travel clinic, targeting a sample of 200 participants. Choice data will be analyzed with conditional logit and multinomial logit models, accounting for individual participant characteristics. Results: An ethics approval was waived by the Ethics Committee Zurich. The study started in September 2019 and estimated data collection and completion is set for January 2020. Five two-level attributes have been selected for inclusion in the DCE, addressing (1) data generation methods, (2) privacy control, (3) data sharing with general practitioner, (4) reminder timing, and (5) costs. Data synthesis, analysis, and reporting are planned for January and February 2020. Results are expected to be submitted for publication by February 2020. Conclusions: Our results will target technology developers, health care providers, and policy makers, potentially offering some guidance on how to design or use sun-protection-focused self-monitoring apps in ways that are responsive to consumer preferences. Preferences are ultimately linked to engagement and motivation, which are key elements for the uptake and success of digital health. Our findings will inform the design of person-centered apps, while also inspiring future preference-eliciting research in the field of emerging and complex eHealth services.

  • Source: Image created by the authors; Copyright: The authors; URL: http://www.researchprotocols.org/2020/2/e14358; License: Creative Commons Attribution (CC-BY).
    Non-randomized Protocols and Methods...

    Feb 14, 2020

    Evaluation of a Rural Emergency Medical Service Project in Germany: Protocol for a Multimethod and Multiperspective Longitudinal Analysis

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    Abstract:

    Background: German emergency medical services are a 2-tiered system with paramedic-staffed ambulances as the primary response, supported by prehospital emergency doctors for life-threatening conditions. As in all European health care systems, German medical practitioners are in short supply, whereas the demand for timely emergency medical care is constantly growing. In rural areas, this has led to critical delays in the provision of emergency medical care. In particular, in cases of cardiac arrest, time is of the essence because, with each passing minute, the chance of survival with good neurological outcome decreases. Objective: The project has 4 main objectives: (1) reduce the therapy-free interval through widespread reinforcement of resuscitation skills and motivating the public to provide help (ie, bystander cardiopulmonary resuscitation), (2) provide faster professional first aid in addition to rescue services through alerting trained first aiders by mobile phone, (3) make more emergency physicians available more quickly through introducing the tele-emergency physician system, and (4) enhance emergency care through improving the cooperation between statutory health insurance on-call medical services (German: Kassenärztlicher Bereitschaftsdienst) and emergency medical services. Methods: We will evaluate project implementation in a tripartite prospective and intervention study. First, in medical evaluation, we will assess the influences of various project measures on quality of care using multiple methods. Second, the economic evaluation will mainly focus on the valuation of inputs and outcomes of the different measures while considering various relevant indicators. Third, as part of the work and organizational analysis, we will assess important work- and occupational-related parameters, as well as network and regional indexes. Results: We started the project in 2017 and will complete enrollment in 2020. We finished the preanalysis phase in September 2018. Conclusions: Overall, implementation of the project will entail realigning emergency medicine in rural areas and enhancing the quality of medical emergency care in the long term. We expect the project to lead to a measurable increase in medical laypersons’ individual motivation to provide resuscitation, to strengthen resuscitation skills, and to result in medical laypersons providing first aid much more frequently. Furthermore, we intend the project to decrease the therapy-free interval in cases of cardiac arrest by dispatching first aiders via mobile phones. Previous projects in urban regions have shown that the tele-emergency physician system can provide a higher availability and quality of emergency call-outs in regular health care. We expect a closer interrelation of emergency practices of statutory health insurance physicians with the rescue service to lead to better coordination of rescue and on-call services.

  • Source: Tired of Cancer BV; Copyright: Tired of Cancer BV; URL: http://www.researchprotocols.org/2020/2/e15969/; License: Licensed by the authors.
    RCTs - Protocols/Proposals (eHealth)

    Feb 14, 2020

    Beating Cancer-Related Fatigue With the Untire Mobile App: Protocol for a Waiting List Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Many cancer patients and survivors worldwide experience disabling fatigue as the main side effect of their illness and the treatments involved. Face-to-face therapy is effective in treating cancer-related fatigue (CRF), but it is also resource-intensive. Offering a self-management program via a mobile phone app (ie, the Untire app), based on elements of effective face-to-face treatments, might increase the number of patients receiving adequate support for fatigue and decrease care costs. Objective: The aim of this protocol is to describe a randomized controlled trial (RCT) to assess the effectiveness of the Untire app in reducing fatigue in cancer patients and survivors after 12 weeks of app use as compared with a waiting list control group. Substudies nested within this trial include questions concerning the reach and costs of online recruitment and uptake and usage of the Untire app. Methods: The Untire app study is a waiting list RCT targeting cancer patients and survivors who experience moderate to severe fatigue via social media (Facebook and Instagram) across 4 English-speaking countries (Australia, Canada, the United Kingdom, and the United States). The Untire app includes psychoeducation and exercises concerning energy conservation, activity management, optimizing restful sleep, mindfulness-based stress reduction, psychosocial support, cognitive behavioral therapy, and physical activity. After randomization, participants in the intervention group could access the Untire app immediately, whereas control participants had no access to the Untire app until the primary follow-up assessment at 12 weeks. Participants completed questionnaires at baseline before randomization and after 4, 8, 12, and 24 weeks. The study outcomes are fatigue (primary) and quality of life (QoL; secondary). Potential moderators and mediators of the hypothesized treatment effect on levels of fatigue and QoL were also assessed. Link clicks and app activation are used to assess reach and uptake, respectively. Log data are used to explore the characteristics of app use. Sample size calculations for the primary outcome showed that we needed to include 164 participants with complete 12-week measures both in the intervention and the control groups. The intention-to-treat approach is used in the primary analyses, which refers to analyzing all participants regardless of their app use. Results: Participants were recruited from March to October 2018. The last participant completed the 24-week assessment in March 2019. Conclusions: This mobile health (mHealth) RCT recruited participants online in multiple countries to examine the uptake and effectiveness of the Untire self-management app to reduce CRF. Many advantages of mHealth apps are assumed, such as the immediate access to the app, the low thresholds to seek support, and the absence of contact with care professionals that will reduce costs. If found effective, this app can easily be offered worldwide to patients experiencing CRF. Trial Registration: Netherlands Trial Register NL6642; https://www.trialregister.nl/trial/6642.

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  • Association between early cannabis and illicit drug use and neurodevelopment, including structural, functional and cognitive outcomes: A systematic review protocol

    Date Submitted: Feb 20, 2020

    Open Peer Review Period: Feb 20, 2020 - Apr 16, 2020

    Background: Illicit drug use and associated harms are highest among young people aged 15-24 years, coinciding with the final stages of neurodevelopment and a period of high neuroplasticity. It is like...

    Background: Illicit drug use and associated harms are highest among young people aged 15-24 years, coinciding with the final stages of neurodevelopment and a period of high neuroplasticity. It is likely that frequent drug use during this time can interfere with fundamental neurophysiological and neuropsychological development pathways and could lead to ongoing unfavourable neuroadaptations. To date, the dose-response relationship between types of illicit drug use, degree of exposure and individual variation is unknown. This is particularly salient due to the shifting legal landscape around drugs such as cannabis and the corresponding liberalisation of attitudes towards the perception of harm. Objective: This systematic review aims to synthesise longitudinal studies that investigate the effects of illicit drug use on structural, functional and cognitive brain domains in individuals under the neural age of adulthood, being 25years. This protocol outlines prospective methods that will facilitate an exhaustive review of the literature exploring pre- and post- drug use brain abnormalities arising during neurodevelopment. Methods: Five electronic databases (Medline, Embase, PsycINFO, ProQuest Central and Web of Science) will be systematically searched between 1990 and 2020. The search terms will be a combinations of MeSH keywords adapted to each database. Study reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and study quality will be assessed using The Grades of Recommendation, Assessment, Development and Evaluation approach. The included studies will be screened against eligibility criteria designed to synthesise studies that considered a sample if youth with exposure to illicit drugs and employed neurobiological, neuropsychological or neuroimaging assessment techniques. Studies will be excluded if participants had been clinically diagnosed with any psychiatric, neurological or pharmacological condition. Results: This is an ongoing review. As of February 2020, papers are in full text screening with results predicted to be complete by July 2020. Conclusions: Integrating the three sources of data will enable an assessment of the links between structural, functional and cognitive brain health across individuals and may support the early detection and prevention of neurodevelopmental harm.

  • A protocol for a pilot randomized controlled trial of guided self-help Behavioral Activation intervention for geriatric depression

    Date Submitted: Feb 15, 2020

    Open Peer Review Period: Feb 14, 2020 - Apr 10, 2020

    Introduction Despite increased incidence of depression in Chinese older populations, they are often misdiagnosed and undertreated, which pose a challenge to our health care system. Evidence-based guid...

    Introduction Despite increased incidence of depression in Chinese older populations, they are often misdiagnosed and undertreated, which pose a challenge to our health care system. Evidence-based guided self-help behavioral activation treatment is effective in reducing anhedonia and amotivation symptoms, however the efficacy in in elderly depressed patients are unknown yet. So the current study aim to pilot the self-help guided intervention for the treatment of depression in elderly patients. Methods and Analysis A two-arm randomized controlled trial will be conducted. Depressed inpatients will be randomized to 6 sessions of guided self-help BA intervention or to a 6-week waiting list control. Guided self-help BA intervention will be delivered over the telephone. Our hypothesis is that guided self-help BA is effective when compared with the waiting-list intervention. Effects of the treatment were observed on three outcomes domains: (1) clinical outcomes (symptom severity, recovery rates); (2) process variables (patient satisfaction, attendance, dropout); and (3) economic outcomes (cost and resource use). We also examine mediators of outcomes in terms of patient variables (behavioral activation/inhibition motivation). This is the first study to investigate guided self-help interventions for Chinese geriatric depressed patients, a group which is currently under-represented in mental health research. The intervention is modular and adapted from an empirically supported behavioral activation treatment for depression (BATD). Ethics and Dissemination The study has ethical approval from the Research Ethics Committee of Mental Health Center of Chongqing (No.2019-055-1). The trial registration number of the current controlled trials is ChiCTR1900026066 which was registered on 20 September 2019. Strengths and limitations of this study: The strengths include random allocation and blinding of study assessors, which enhance internal validity of the results. In addition, the moderators of health outcome measures in BA focused on behavioral activation/inhibition motivation, which is underrepresented in previous study on BA intervention. We also focused on the clinical efficacy as well as effectiveness of guided self-help intervention in the context of the inpatient service of a psychiatric hospital. The limitations of the study are generalizability which is limited in the inpatients of Geriatric Depression, which is commonly comorbid with physical illnesses. In addition, this initial study will be based in Chongqing, the western city of China, which experiences the most rapid aging speed.

  • Guided Internet-Based Cognitive Behavioral Therapy for Japanese Patients with Obsessive-Compulsive Disorder: A Protocol of the Randomized Controlled Trial

    Date Submitted: Feb 12, 2020

    Open Peer Review Period: Feb 12, 2020 - Apr 8, 2020

    Background: Cognitive behavioral therapy (CBT) for obsessive-compulsive disease (OCD) has been established, but access to CBT in Japan is limited. Internet-based cognitive behavioral therapy (ICBT) ma...

    Background: Cognitive behavioral therapy (CBT) for obsessive-compulsive disease (OCD) has been established, but access to CBT in Japan is limited. Internet-based cognitive behavioral therapy (ICBT) may improve treatment accessibility and sufficiently improve obsessive-compulsive symptoms. Because there are few randomized controlled trials, it is necessary to examine the effectiveness of ICBT in patients with OCD. We designed a randomized controlled trial (RCT) protocol between guided ICBT and the control group in Japanese patients with OCD. Objective: We reported a protocol for a randomized controlled trial of ICBT in Japanese patients with OCD. Methods: RCT comprised two parallel groups (ICBT and UC) consisting of 15 participants each (n=30) diagnosed with OCD. We will evaluate the effectiveness of twelve intervention weeks. The primary outcome of symptoms’ severity will be the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Secondary outcomes include the Obsessive-Compulsive Inventory (OCI), Beck Anxiety Inventory (BAI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Working Alliance Inventory-Short Form (WAI-SF), and quality of life in Euro Qol-5D. All measures will be assessed at weeks 0 (baseline) and 12 (follow-up). In the statistical analysis comparing treatment effects, the least-squares means and their 95% CIs will be estimated by analysis of covariance (ANCOVA) with the change in total outcomes' scores at week 12. All comparisons are planned, and all P values will be two-sided. P values < 0.05 will be considered statistically significant. Results: The study will be implemented from January 2020 to March 2021, and results are expected to be available in mid-2021. Conclusions: The protocol suggested that the way to reduce nonbeneficial invasive treatments for OCD patients, and a systematic approach to improve access to CBT in Japan. Clinical Trial: UMIN: 000044422

  • The THRIVE Study: Protocol for a longitudinal case-control study on the role of stress and genital immunity in sexual trauma and HIV susceptibility among adolescent girls and adult women

    Date Submitted: Feb 12, 2020

    Open Peer Review Period: Feb 10, 2020 - Apr 6, 2020

    Background: The relationship between sexual violence and HIV risk has been extensively documented through social and behavioral research; by contrast, the explanatory underlying biological mechanisms...

    Background: The relationship between sexual violence and HIV risk has been extensively documented through social and behavioral research; by contrast, the explanatory underlying biological mechanisms are poorly understood. Objective: The purpose of the THRIVE Study is to examine the impact of sexual trauma on HIV susceptibility through dysregulation of: (a) soluble inflammatory and anti-inflammatory/anti-HIV biomarkers in the female genital tract and (b) the hypothalamic-pituitary-adrenal axis, among adolescent girls and adult women. Methods: The THRIVE study is a longitudinal case-control study conducted in San Diego, California, USA among a racially diverse sample. Cases are adolescent girls (aged 14-19) or adult women (aged 20-45) who have experienced vaginal sexual trauma perpetrated by a male within the past 15 days. Controls are adolescent girls or adult women who have engaged in consensual vaginal sex with a male within the past 15 days. At baseline, 1- and 3-month follow-up study visits, participants undergo: (1) a urine-based pregnancy test, (2) venipuncture blood draw for HIV, C-reactive protein, adrenocorticotropic hormone and progesterone testing, (3) a 45-minute interviewer-administered computer survey, and (4) cervicovaginal lavage to measure pro-inflammatory and anti-inflammatory/anti-HIV soluble immune biomarkers. After each study visit, participants self-collect saliva specimens (upon waking, 30-minutes post-waking, and 45-minutes post-waking) at home for three consecutive days, which is later assayed for cortisol and dehydroepiandrosterone sulfate. Participants receive compensation at each study visit and for the return of saliva specimens, plus a list of local medical and support services. Study procedures utilize trauma-informed care methods, given the sensitive nature of the study and enrollment of women in the acute phase post-sexual trauma. All research staff and investigators adhere to ethical principles and guidelines in the conduct of research activities. Data will be analyzed for descriptive and inferential analysis. Results: Presently, recruitment of participants is ongoing. Publication of first results is expected by late 2021. Conclusions: The THRIVE Study will deliver foundational knowledge on how sexual trauma increases susceptibility to HIV acquisition via alterations in cervicovaginal immune regulation and the psychobiology of the stress responses. Findings will inform future research on mechanistic models of in-vitro and in-vivo injury and cervicovaginal wound healing processes, which may lead to non-vaccine biomedical HIV prevention products for girls and women. Clinical Trial: Not applicable.

  • The Effects of Radiotherapy and Comorbidity on Health-Related Quality Of Life and Mortality among Older Women with Low-Risk Breast Cancer: Proposal For a Retrospective Longitudinal Study

    Date Submitted: Feb 7, 2020

    Open Peer Review Period: Feb 7, 2020 - Apr 3, 2020

    Background: The National Comprehensive Cancer Network Breast Cancer Guidelines Committee has suggested that the omission of adjuvant radiation therapy (RT) after breast-conserving surgery can be a rea...

    Background: The National Comprehensive Cancer Network Breast Cancer Guidelines Committee has suggested that the omission of adjuvant radiation therapy (RT) after breast-conserving surgery can be a reasonable option among older women with low-risk breast cancer (early-stage, ER-positive, and node-negative) if they are treated with endocrine therapy. However, RT usage in this group of women still exceeds 50%. On the other hand, older women tend to forego RT (even when necessary) due to cost, inconvenience, and potential adverse responses associated with RT. Understanding health-related quality of life (HRQOL) change with receipt of RT among older women in the modern era is limited due to the underrepresentation of this population in clinical trials. Objective: The proposed study aims to examine the associations of RT with HRQOL trajectories as well as survival outcomes among older women over 5-10 year follow-up. We will also assess whether pre-diagnosis comorbidity burden influences receipt of RT and whether the associations between RT and HRQOL trajectory and survival outcomes are modified by comorbidity burden. Methods: We will use a retrospective cohort study design with the population-based database of Surveillance, Epidemiology, and End-Results linked to the Medicare Health Outcomes Survey (SEER-MHOS). Older women (65+) diagnosed with low-risk breast cancer in 1998-2014, received BCS, and participated in MHOS 1998-2016 are eligible for the current analysis. The clustering method, latent class analysis, will be used to identify each patient’s pre-diagnosis comorbidity burden, and HRQOL will be evaluated using SF-36/VR-12 scales. The inverse-weighted estimates of the probability of treatment will be included as a covariate to control for treatment selection bias and confounding effects in subsequent analysis. The association of RT with HRQOL trajectory will be evaluated using inverse-weighted semiparametric B-splines models. The inverse-weighted Cox regression model will be used to obtain hazard ratios with 95% confidence intervals for the association of RT with survival outcomes. Differential effects of RT on both outcomes according to comorbidity burden class will also be evaluated. Results: As of January 2020, the study was approved by the institutional review board, and the SEER-MHOS data was obtained from the National Cancer Institute and SEER. Women with low-risk breast cancer who met inclusion and exclusion criteria have been identified, and pre-diagnosis comorbidity burden has been characterized using latent class analysis. Further data analysis will begin in February 2020, and the first manuscript will be submitted in a peer-reviewed journal in June 2020. Conclusions: This research has the potential to improve clinical outcomes of older women with low-risk breast cancer by providing them additional information on the HRQOL trajectories when they make RT treatment-decision. It will facilitate informed, shared treatment decision and cancer care planning and ultimately will improve the HRQOL of older women with breast cancer. Clinical Trial: NA

  • My Understanding of Drug Use Experiences (MiUSE): a protocol for the development of a digitally delivered harm reduction intervention for students in higher education.

    Date Submitted: Jan 15, 2020

    Open Peer Review Period: Jan 15, 2020 - Mar 11, 2020

    Background: Digital interventions have been identified as a possible tool in the reduction of harm from illicit drug use among students attending higher education (i.e. college students). However inte...

    Background: Digital interventions have been identified as a possible tool in the reduction of harm from illicit drug use among students attending higher education (i.e. college students). However intervention success in this area to date has been hampered by a lack of user involvement and behavior change theory in their design. The MiUSE project will combine a rigorous user-centered design methodology, with robust behavioral change theories to develop a digital harm-reduction intervention for illicit drug use among students in higher education. Objective: The objective of this project is to design and develop a digital intervention that targets drug use related harm in higher education students. Methods: The MiUSE project will take place over three phases. The first phase, was exploratory in nature; involving the conduct of three systematic reviews, the administration of a large survey, and the conduct of student workshops to gather a comprehensive evidence base to guide the project. The second phase is the development stage of the project, involving the use of the Behavior Change Wheel theoretical model to determine the behavioral change components of the intervention, and the use of the User Centered Design methodology to guide the development of the digital intervention. The third phase is the evaluation stage, whereby the intervention will undergo a five-stage evaluation process to comprehensively evaluate its impacts. Results: The exploratory phase 1 of the MiUSE project was completed in December 2018. Phase 2 is currently underway, and Phase 3 is due to begin in June 2020. Conclusions: Higher education institutions are ideally placed to intervene and support students in the area of illicit drug use, but are constrained by limited resources. Current digital interventions in this area are sparse, and have several weaknesses. The MiUSE project draws on learnings from previous work, utilizing robust methodologies in an attempt to develop a digital intervention that is economically viable, effective in changing behavior, usable and acceptable to students, and able to sustain long-term implementation in higher education institutions.

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