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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed-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), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions.

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:

  • Counselor using the StandStrong app during a psychosocial counseling session with a young adolescent mother. Source: Image created by the Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2019/9/e14734/; License: Creative Commons Attribution (CC-BY).
    Non-randomized Protocols and Methods...

    Sep 11, 2019

    Wearable Digital Sensors to Identify Risks of Postpartum Depression and Personalize Psychological Treatment for Adolescent Mothers: Protocol for a Mixed...

    Authors List:

    Abstract:

  • Diabetes blood glucose test sugar insulin meter. Source: Pixabay; Copyright: Peejhunt; URL: https://pixabay.com/photos/diabetes-blood-glucose-test-sugar-2424105/; License: Licensed by the authors.
    Non-Randomized Study Protocols and...

    Sep 6, 2019

    Exploring Severe Mental Illness and Diabetes: Protocol for a Longitudinal, Observational, and Qualitative Mixed Methods Study

    Authors List:

    Abstract:

    Background: The average life expectancy for people with a severe mental illness (SMI) such as schizophrenia or bipolar disorder is 15 to 20 years less than that for the population as a whole. Diabetes contributes significantly to this inequality, being 2 to 3 times more prevalent in people with SMI. Various risk factors have been implicated, including side effects of antipsychotic medication and unhealthy lifestyles, which often occur in the context of socioeconomic disadvantage and health care inequality. However, little is known about how these factors may interact to influence the risk of developing diabetes and poor diabetic outcomes, or how the organization and provision of health care may contribute. Methods: This study will employ a concurrent mixed methods design combining the interrogation of electronic primary care health records from the Clinical Practice Research Datalink (CPRD GOLD) with qualitative interviews with adults with SMI and diabetes, their relatives and friends, and health care staff. The study has been funded for 2 years, from September 2017 to September 2019, and data collection has recently ended. Results: CPRD and linked health data will be used to explore the association of sociodemographics, illness, and health care–related factors with both the development and outcomes of type 2 diabetes in people with SMI. Experiences of managing the comorbidity and accessing health care will be explored through qualitative interviews using topic guides informed by evidence synthesis and expert consultation. Findings from both datasets will be merged to develop a more comprehensive understanding of diabetes risks, interventions, and outcomes for people with SMI. Findings will be translated into recommendations for interventions and services using co-design workshops. Conclusions: Improving diabetes outcomes for people with SMI is a high-priority area nationally and globally. Understanding how risk factors combine to generate high prevalence of diabetes and poor diabetic outcomes for this population is a necessary first step in developing health care interventions to improve outcomes for people with diabetes and SMI.

  • Source: freepik; Copyright: freepik; URL: https://www.freepik.com/free-photo/young-couple-sitting-together-sofa-using-mobile-phone_4503190.htm#page=1&query=woman%20on%20phone&position=15; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (funded,...

    Sep 3, 2019

    The Effectiveness of Educational Mobile Messages for Assisting in the Prevention of Early Childhood Caries: Protocol for a Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: In 2017, approximately 3.7 billion downloads of health apps were made on mobile phones and tablets. In this sense, a massive number of people could benefit by electronic mobile–based health interventions, making information available even with the lack of material and human resources. Hence, the use of electronic apps for dental education might be extremely useful for the prevention of early childhood caries (ECC). Objective: This study aims to evaluate the effectiveness of messages sent via mobile phones as an adjuvant method for the prevention of ECC. Methods: A single-blinded, randomized, and parallel-group clinical trial will be conducted with dyads of parents or caregivers and children aged between 36 and 60 months, recruited from kindergartens and schools of Bauru, São Paulo. The determination of sample size resulted in a total of 104 dyads of parents and children, considering a power of 80%, a significance level of 5%, and an attrition of 30%. This sample will be randomly assigned to test and control groups, being divided in 52 dyads per group according to the health literacy levels of parents and the age, gender, and oral health status of children. Every 2 weeks, only participants in the test group will receive messages via WhatsApp containing preventive and education-related ECC information. The dyads will visit the dentist every 3 months during a year for the assessment of primary outcomes (sugar consumption and the International Caries Detection and Assessment System, visible plaque, and community periodontal indices) and to receive dental care measures. Secondary outcomes (electronic health literacy and general perceived self-efficacy) will be determined only at baseline and after 12-month follow-up. The quality of randomization will be evaluated throughout the study, comparing the test and control groups systematically by Student t tests for continuous variables and chi-square tests for categorical variables. Listwise deletion method will be applied in cases of dropouts, if the missing values satisfy the criteria of missing completely at random; otherwise, multiple imputation data strategy will be conducted. The Kolmogorov-Smirnov and Levene tests will be used to determine the normality and homogeneity of data, respectively, which will indicate further statistical analyses for elucidating significant differences between groups (P<.05). A Student t test or Mann-Whitney U test will be employed for parametric or nonparametric analyses, respectively. Results: The project was funded in 2018, and enrollment was completed in August 2019. Allocation is currently under way and the first results are expected to be submitted for publication in 2020. Conclusions: The results will contribute to understanding the importance of educational mobile messages toward the adoption of healthy behaviors for the prevention of ECC in a given population. Trial Registration: Brazilian Registry of Clinical Trials Universal Trial Number U1111-1216-1393; http://www.ensaiosclinicos.gov.br/rg/RBR-2b6r7q International Registered Report Identifier (IRRID): PRR1-10.2196/13656

  • A newborn with cardiorespiratory monitoring attached. Source: Flickr; Copyright: Mattman4698; URL: https://www.flickr.com/photos/mattman/268593805/in/photolist-pJBzF-bzTrLX-2RYWkN-62fQ4U-9jWd2P-iSsKXC-9iqNF1-FUE2wb-hqRido-6Yrm1Z-dLa7Nv-eGw8rn-9J7Sfm-VqYs6k-53bMM2-7bqFvE-5Y2KaF-7bmNfB-WsSM6e-7aTxdA-pu6cC-7M2ARq-4SGLAr-84Vnak-jt5BAR-cGiqRd-5fVFi7-dfq7oC-; License: Creative Commons Attribution + Noncommercial (CC-BY-NC).
    Methods and Feasibility Studies

    Aug 29, 2019

    Noncontact Heart and Respiratory Rate Monitoring of Preterm Infants Based on a Computer Vision System: Protocol for a Method Comparison Study

    Authors List:

    Abstract:

    Background: Biomedical research in the application of noncontact methods to measure heart rate (HR) and respiratory rate (RR) in the neonatal population has produced mixed results. This paper describes and discusses a protocol for conducting a method comparison study, which aims to determine the accuracy of a proposed noncontact computer vision system to detect HR and RR relative to the HR and RR obtained by 3-lead electrocardiogram (ECG) in preterm infants in the neonatal unit. Methods: A single-center cross-sectional study was planned to be conducted in the neonatal unit at Flinders Medical Centre, South Australia, in May 2018. A total of 10 neonates and their ECG monitors will be filmed concurrently for 10 min using digital cameras. Advanced image processing techniques are to be applied later to determine their physiological data at 3 intervals. These data will then be compared with the ECG readings at the same points in time. Results: Study enrolment began in May 2018. Results of this study were published in July 2019. Conclusions: The study will analyze the data obtained by the noncontact system in comparison to data obtained by ECG, identify factors that may influence data extraction and accuracy when filming infants, and provide recommendations for how this noncontact system may be implemented into clinical applications.

  • Source: Foter; Copyright: Trend Hype; URL: https://foter.com/photo2/woman-touching-tablet-screen/; License: Public Domain (CC0).
    Non-randomized Protocols and Methods...

    Aug 28, 2019

    Development of a Caregivers’ Support Platform (Connected Health Sustaining Home Stay in Dementia): Protocol for a Longitudinal Observational Mixed Methods...

    Authors List:

    Abstract:

    Background: Dementia disease is a chronic condition that leads a person with dementia (PwD) into a state of progressive deterioration and a greater dependence in performing their activities of daily living (ADL). It is believed nowadays that PwDs and their informal caregivers can have a better life when provided with the appropriate services and support. Connected Health (CH) is a new technology-enabled model of chronic care delivery where the stakeholders are connected through a health portal, ensuring continuity and efficient flow of information. CH has demonstrated promising results regarding supporting informal home care and Aging in Place, and it has been increasingly considered by researchers and health care providers as a method for dementia home care management. Objective: This study aims to describe the development and implementation protocol of a CH platform system to support informal caregivers of PwDs at home. Methods: This is a longitudinal observational mixed methods study where quantitative and qualitative data will be combined for determining the utility of the CH platform for dementia home care. Dyads, consisting of a PwD and their informal caregiver living in the community, will be divided into 2 groups: the intervention group, which will receive the CH technology package at home, and the usual care group, which will not have any CH technology at all. Dyads will be followed up for 12 months during which they will continue with their traditional care plan, but in addition, the intervention group will receive the CH package for their use at home during 6 months (months 3 to 9 of the yearly follow-up). Further comprehensive assessments related to the caregiver’s and PwD’s emotional and physical well-being will be performed at the initial assessment and at 3, 6, 9, and 12 months using international and standardized validated questionnaires and semistructured individual interviews. Results: This 3-year funded study (2016-2019) is currently in its implementation phase and is expected to finish by December 2019. We believe that CH can potentially change the PwD current care model, facilitating a proactive and preventive model, utilizing self-management–based strategies, and enhancing caregivers’ involvement in the management of health care at home for PwDs. Conclusions: We foresee that our CH platform will provide knowledge and promote autonomy for the caregivers, which may empower them into greater control of the care for PwDs, and with it, improve the quality of life and well-being for the person they are caring for and for themselves through a physical and cognitive decline predictive model. We also believe that facilitating information sharing between all the PwDs’ care stakeholders may enable a stronger relationship between them, facilitate a more coordinated care plan, and increase the feelings of empowerment in the informal caregivers. International Registered Report Identifier (IRRID): DERR1-10.2196/13280

  • Source: freepik; Copyright: freepik; URL: https://www.freepik.com/free-photo/positive-businessman-using-laptop_2192610.htm#page=4&query=using+computer&position=3; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (eHealth)

    Aug 26, 2019

    A Systematic Framework for Analyzing Patient-Generated Narrative Data: Protocol for a Content Analysis

    Authors List:

    Abstract:

    Background: Patient narrative data in online health care forums (communities) are receiving increasing attention from the scientific community for implementing patient-centered care. Natural language processing (NLP) methods are gaining more and more attention because of the enormous data volume. However, state-of-the-art NLP still cannot meet the need of high-resolution analysis of patients’ narratives. Manual qualitative analysis still plays a pivotal role in answering complicated research questions from analyzing patient narratives. Methods: Our systematic framework consists of 4 phases: (1) data collection, (2) data preparation, (3) content analysis, and (4) interpretation of the results. Data collection and data preparation phases are constructed based on text mining methods for identifying appropriate online health forums for data collection, differentiating posts of patients from other stakeholders, protecting patients’ privacy, sampling, and choosing the unit of analysis. Content analysis phase is built on the framework method, which facilitates and accelerates the identification of patterns and themes by an interdisciplinary research team. In the end, the focus of interpretation of the results phase is to measure the data quality and interpret the findings regarding the dimensions and aspects of patients’ experiences and concerns in their original contexts. Results: We demonstrated the usability of the proposed systematic framework using 2 case studies: one on determining factors affecting patients’ attitudes toward antidepressants and another on identifying the disease management strategies in patient with diabetes facing financial difficulties. The framework provides a clear step-by-step process for systematic content analysis of patient narratives and produces high-quality structured results that can be used for describing patterns or regularities in patients’ experiences, generating and testing hypotheses, and identifying areas of improvement in the health care systems. Conclusions: The systematic framework is a rigorous and standardized method for qualitative analysis of patient narratives. Findings obtained through such a process indicate authentic dimensions and aspects of patient experiences and shed light on patients’ concerns, needs, preferences, and values, which are the core of patient-centered care.

  • Source: World Obesity Federation; Copyright: World Obesity Federation; URL: https://www.worldobesity.org/resources/image-bank/business-women-working-in-the-office; License: Licensed by the authors.
    Proposals (non-eHealth)

    Aug 26, 2019

    Predictors Linking Obesity and the Gut Microbiome (the PROMISE Study): Protocol and Recruitment Strategy for a Cross-Sectional Study on Pathways That Affect...

    Authors List:

    Abstract:

    Background: The prevalence of obesity has increased substantially over recent decades and is associated with considerable health inequalities. Although the causes of obesity are complex, key drivers include overconsumption of highly palatable, energy-dense, and nutrient-poor foods, which have a profound impact on the composition and function of the gut microbiome. Alterations to the microbiome may play a critical role in obesity by affecting energy extraction from food and subsequent energy metabolism and fat storage. Methods: Healthy Pacific and New Zealand (NZ) European women aged between 18 and 45 years from the Auckland region were recruited for this cross-sectional study. Participants were recruited such that half in each group had either a normal weight (body mass index [BMI] 18.5-24.9 kg/m2) or were obese (BMI ≥30.0 kg/m2). In addition to anthropometric measurements and assessment of the body fat content using dual-energy x-ray absorptiometry, participants completed sweet, fat, and bitter taste perception tests; food records; and sleep diaries; and they wore accelerometers to assess physical activity and sleep. Fasting blood samples were analyzed for metabolic and endocrine biomarkers and DNA extracted from fecal samples was analyzed by shotgun sequencing. Participants completed questionnaires on dietary intake, eating behavior, sleep, and physical activity. Data were analyzed using descriptive and multivariate regression methods to assess the associations between dietary intake, taste perception, sleep, physical activity, gut microbiome complexity and functionality, and host metabolic and body fat profiles. Results: Of the initial 351 women enrolled, 142 Pacific women and 162 NZ European women completed the study protocol. A partnership with a Pacific primary health and social services provider facilitated the recruitment of Pacific women, involving direct contact methods and networking within the Pacific communities. NZ European women were primarily recruited through Web-based methods and special interest Facebook pages. Conclusions: This cross-sectional study will provide a wealth of data enabling the identification of distinct roles for diet, taste perception, sleep, and physical activity in women with different body fat profiles in modifying the gut microbiome and its impact on obesity and metabolic health. It will advance our understanding of the etiology of obesity and guide future intervention studies involving specific dietary approaches and microbiota-based therapies.

  • Source: Stocksnap; Copyright: Mathew Henry; URL: https://stocksnap.io/photo/Z86OD8RAAI; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (funded,...

    Aug 23, 2019

    Examining the Impact of a Personalized Self-Management Lifestyle Program Using Mobile Technology on the Health and Well-Being of Cancer Survivors: Protocol...

    Authors List:

    Abstract:

    Background: Cancer survivorship in Ireland is increasing in both frequency and longevity. However, a significant proportion of cancer survivors are overweight. This has negative implications for long-term health outcomes, including increased risk of subsequent and secondary cancers. There is a need to identify interventions, which can improve physical and psychological outcomes that are practical in modern oncology care. Mobile health (mHealth) interventions demonstrate potential for positive health behavior change, but there is little evidence for the efficacy of mobile technology to improve health outcomes in cancer survivors. Objective: This study aims to investigate whether a personalized mHealth self-management lifestyle program is acceptable to participants and can improve physical and psychological outcomes of a subgroup of cancer survivors with increased health risks related to lifestyle behaviors. Methods: A sample of 123 cancer survivors (body mass index >25 kg/m2) was randomly assigned to the control (n=61) or intervention (n=62) group. The intervention group attended a 4-hour tailored lifestyle information session with a physiotherapist, dietician, and clinical psychologist to support self-management of health behavior. Over the following 12 weeks, participants engaged in personalized goal setting to incrementally increase physical activity (with feedback and review of goals through short message service text messaging contact). Objective measures of health behavior (ie, physical activity) were collected using Fitbit (Fitbit, Inc). Data on anthropometric, physiological, dietary behavior, and psychological measures were collected at baseline (T0), 12 weeks (T1; intervention end), and 24 weeks (T2; follow-up). Semistructured interviews were conducted to explore the retrospective acceptability of the Moving On program from the perspective of the recipients. Results: This paper details the protocol for the Moving On study. The project was funded in August 2017. Enrolment started in December 2017. Data collection completed in September 2018. Data analysis is underway, and results are expected in winter 2019. Conclusions: The results of this study will determine the efficacy and acceptability of an mHealth intervention using behavior change techniques to promote health behaviors that support physical health and well-being in cancer survivors and will therefore have implications for health care providers, patients, health psychologists, and technologists. International Registered Report Identifier (IRRID): DERR1-10.2196/13214

  • Source: freepik; Copyright: peoplecreations; URL: https://www.freepik.com/free-photo/surgeons-performing-operation-operation-room_1008432.htm; License: Licensed by JMIR.
    Systematic Review Protocols

    Aug 20, 2019

    Radiofrequency-Assisted Liver Resection Versus Clamp-Crush Liver Resection: Protocol for an Updated Meta-Analysis and Systematic Review

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    Abstract:

    Background: Malignancy of the liver has historically meant a poor prognosis and remains the second most common cause of cancer-related deaths globally. Traditionally, hepatectomy has utilized the clamp-crush technique; however, this is associated with high incidence of postoperative complications. Many novel techniques have been developed—radiofrequency ablation and transarterial chemoembolization; however, these are not applicable to numerous cases. Clamp-crush liver resection (CCLR) remains the gold standard. Radiofrequency-assisted liver resection (RFLR) is a technique that aims to reduce mortality through bloodless liver resection. A systematic review was previously performed on RFLR but the results neither recommended nor refuted the use of RFLR owing to the lack of sufficient evidence from well-designed randomized controlled trials (RCTs) at the time. Methods: Articles comparing RFLR and CCLR that were published from 2014 until 2019 will be reviewed and relevant data will be extracted and statistically analyzed through Review Manager 5 (by the Cochrane Collaboration) together with the results of the previous meta-analysis. Results: Data collection is currently underway, with papers being screened. We hope to publish the results by the end of 2019. Conclusions: Given the high mortality rates currently associated with liver resection, it is imperative that novel surgical techniques are undertaken and investigated so we can improve best practice guidance and outcomes.

  • Source: Markham Stouffville Hospital; Copyright: Markham Stouffville Hospital; URL: https://www.researchprotocols.org/2019/8/e13920; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (eHealth)

    Aug 19, 2019

    Technology-Enabled Self-Monitoring of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Protocol for a Randomized...

    Authors List:

    Abstract:

    Background: Chronic obstructive pulmonary disease (COPD) is the third leading cause of mortality worldwide. Reducing the number of COPD exacerbations is an important patient outcome and a major cost-saving approach. Both technology-enabled self-monitoring (SM) and remote monitoring (RM) programs have the potential to reduce exacerbations, but they have not been directly compared with each other. As RM is a more resource-intensive strategy, it is important to understand whether it is more effective than SM. Objective: The objective of this study is to evaluate the impact of SM and RM on self-management behaviors, COPD disease knowledge, and respiratory status relative to standard care (SC). Methods: This was a 3-arm open-label randomized controlled trial comparing SM, RM, and SC completed in an outpatient COPD clinic in a community hospital. Patients in the SM and RM groups recorded their vital signs (oxygen, blood pressure, temperature, and weight) and symptoms with the Cloud DX platform every day and were provided with a COPD action plan. Patients in the RM group also received access to a respiratory therapist (RT). The RT monitored their vital signs intermittently and contacted them when their vitals varied outside of predetermined thresholds. The RT also contacted patients once a week irrespective of their vital signs or symptoms. All patients were randomized to 1 of the 3 groups and assessed at baseline and 3 and 6 months after program initiation. The primary outcome was the Partners in Health scale, which measures self-management skills. Secondary outcomes included the St. George's Respiratory Questionnaire, Bristol COPD Knowledge Questionnaire, COPD Assessment Test, and modified-Medical Research Council Breathlessness Scale. Patients were also asked to self-report on health system usage. Results: A total of 122 patients participated in the study, 40 in the SC, 41 in the SM, and 41 in the RM groups. Out of those patients, 7 in the SC, 5 in the SM, and 6 in the RM groups did not complete the study. There were no significant differences in the rates of study completion among the groups (P=.80). Conclusions: Both SM and RM have shown promise in reducing acute care utilization and exacerbation frequencies. As far as we are aware, no studies to date have directly compared technology-enabled self-management with RM programs in COPD patients. We believe that this study will be an important contribution to the literature. Trial Registration: ClinicalTrials.gov NCT03741855; https://clinicaltrials.gov/ct2/show/NCT03741855 International Registered Report Identifier (IRRID): DERR1-10.2196/13920

  • Source: freepik; Copyright: yanalya; URL: https://www.freepik.com/free-photo/female-hands-holding-pill-glass-water-closeup-view_3954458.htm#page=1&query=Antidepressants&position=1; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (non-eHealth)

    Aug 19, 2019

    Using Pharmacogenomic Testing in Primary Care: Protocol for a Pilot Randomized Controlled Study

    Authors List:

    Abstract:

    Background: Antidepressants are used by primary care providers to treat a variety of conditions, including (but not limited to) depression and anxiety. A trial-and-error approach is typically used to identify effective therapy, as treatment efficacy and safety can vary based on the response, which is affected by certain gene types. Pharmacokinetic pharmacogenomic (PGx) testing provides phenotypic classification of individuals as poor, intermediate, extensive, and ultrarapid CYP450 metabolizers, providing information for optimal drug selection. Objective: The objective of this pilot study is to examine the feasibility, acceptability, and preliminary effectiveness of PGx testing when used after starting a new antidepressant medication. Methods: We are conducting a pilot study with physicians from 6 Department of Family Medicine clinics at the University of Michigan who are willing to use PGx test results to manage antidepressant medication use. From enrolled physicians, patients were recruited to participate in a 6-month randomized, wait-list controlled trial in which patient participants newly prescribed an antidepressant had PGx testing and were randomized equally to have the results released to their primary care physician as soon as results were available or after 3 months. Patients were excluded if they had been taking the antidepressant for more than 4 weeks or if they had undergone PGx testing in the past. Physician participants completed a baseline survey to assess demographics, as well as knowledge, feasibility, and acceptability of PGx testing for this population. At the conclusion of the study, physician participants will complete a survey to assess knowledge, satisfaction, feasibility, acceptability, perceived effectiveness, and barriers to widespread adoption of PGx testing. Patient participants will complete a baseline, 3-month, and 6-month assessment, and control patient participants will have an additional 9-month assessment. Data collected will include the reason for antidepressant use, self-reported medication adherence, side effects, patient health questionnaire 8-item depression scale, generalized anxiety disorder 7-item scale, 12-Item Short-Form Health Survey, work status or changes, and physician and emergency department visits. PGx knowledge and perceptions (including acceptability and feasibility) as well as demographic information will also be obtained. Results: We recruited 23 physician participants between November 2017 and January 2019, and 52 patient participants between January 2018 and April 2019. Currently, all physician and patient participants have been recruited, and we expect data collection to conclude in January 2020. Conclusions: This study will examine the preliminary effectiveness of PGx testing after treatment initiation and determine the feasibility and acceptability of PGx testing for use in primary care. Through this study, we expect to demonstrate the benefit of PGx testing and lay the foundation for translating this approach into use within primary care. Trial Registration: ClinicalTrials.gov NCT03270891; https://clinicaltrials.gov/ct2/show/NCT03270891 International Registered Report Identifier (IRRID): RR1-10.2196/13848

  • Researcher in antenatal clinic during screening program recruitment. Source: Rebecca Blackmore; Copyright: The Authors; URL: https://www.researchprotocols.org/2019/8/e13271/; License: Creative Commons Attribution (CC-BY).
    Non-Randomized Study Protocols and...

    Aug 19, 2019

    Improving Mental Health in Pregnancy for Refugee Women: Protocol for the Implementation and Evaluation of a Screening Program in Melbourne, Australia

    Authors List:

    Abstract:

    Background: Identifying mental health disorders in migrant and refugee women during pregnancy provides an opportunity for interventions that may benefit women and their families. Evidence suggests that perinatal mental health disorders impact mother-infant attachment at critical times, which can affect child development. Postnatal depression resulting in suicide is one of the leading causes of maternal mortality postpartum. Routine screening of perinatal mental health is recommended to improve the identification of depression and anxiety and to facilitate early management. However, screening is poorly implemented into routine practice. This study is the first to investigate routine screening for perinatal mental health in a maternity setting designed for refugee women. This study will determine whether symptoms of depression and anxiety are more likely to be detected by the screening program compared with routine care and will evaluate the screening program’s feasibility and acceptability to women and health care providers (HCPs). Objective: The objectives of this study are (1) to assess if refugee women are more likely to screen risk-positive for depression and anxiety than nonrefugee women, using the Edinburgh Postnatal Depression Scale (EPDS); (2) to assess if screening in pregnancy using the EPDS enables better detection of symptoms of depression and anxiety in refugee women than current routine care; (3) to determine if a screening program for perinatal mental health in a maternity setting designed for refugee women is acceptable to women; and (4) to evaluate the feasibility and acceptability of the perinatal mental health screening program from the perspective of HCPs (including the barriers and enablers to implementation). Methods: This study uses an internationally recommended screening measure, the EPDS, and a locally developed psychosocial questionnaire, both administered in early pregnancy and again in the third trimester. These measures have been translated into the most common languages used by the women attending the clinic and are administered via an electronic platform (iCOPE). This platform automatically calculates the EPDS score and generates reports for the HCP and woman. A total of 119 refugee women and 155 nonrefugee women have been recruited to evaluate the screening program’s ability to detect depression and anxiety symptoms and will be compared with 34 refugee women receiving routine care. A subsample of women will participate in a qualitative assessment of the screening program’s acceptability and feasibility. Health service staff have been recruited to evaluate the integration of screening into maternity care. Results: The recruitment is complete, and data collection and analysis are underway. Conclusions: It is anticipated that screening will increase the identification and management of depression and anxiety symptoms in pregnancy. New information will be generated on how to implement such a program in feasible and acceptable ways that will improve health outcomes for refugee women. International Registered Report Identifier (IRRID): DERR1-10.2196/13271

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    Date Submitted: Aug 22, 2019

    Open Peer Review Period: Aug 22, 2019 - Oct 17, 2019

    Background: Many patients and survivors of cancer worldwide experience disabling fatigue as the number one side effect of their illness and the treatments involved. Face-to-face therapy is effective i...

    Background: Many patients and survivors of cancer worldwide experience disabling fatigue as the number one 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 application (i.e., 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: This protocol describes a randomized controlled trial to assess the effectiveness of the Untire app in reducing fatigue in patients and survivors of cancer after 12 weeks of app use as compared to 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 randomized controlled trial targeting (former) patients with cancer who experience moderate to severe fatigue via social media (Facebook and Instagram) across four English-speaking countries (Australia, Canada, the United Kingdom, and the United States of America). The Untire app includes psycho-education and exercises concerning energy conservation, activity management, optimizing restful sleep, mindfulness-based stress reduction (MBSR), psychosocial support, cognitive behavioral therapy (CBT), 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-weeks measures both in the intervention and the control group. Results: The recruitment started in March 2018, and the last participants completed their 24-weeks assessment in March 2019. Conclusions: This mHealth intervention trial recruited participants online in multiple countries worldwide to examine the uptake and effectiveness of the Untire self-management app to reduce CRF. Many advantages of mobile health apps are assumed, such as the immediate access to the app, the low thresholds to seek support, and the absence of contact with care professional that will reduce costs. If effective, this app can easily be offered worldwide to patients and survivors of cancer experiencing CRF. Clinical Trial: The trial has been registered on 29/11/2019 on Trial Registry (www.trialregister.nl; NL6642).

  • The SEAMLESS Study: Protocol for a clinical trial evaluating a SmartphonE App-based MindfuLnEss intervention for cancer SurvivorS

    Date Submitted: Aug 19, 2019

    Open Peer Review Period: Aug 21, 2019 - Oct 16, 2019

    Background: Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurre...

    Background: Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts and geography. Smartphone app-based MBIs are an innovative way to deliver psychosocial cancer-care, and can overcome several such difficulties, since patients can participate at their own convenience. However, while hundreds of mindfulness training apps are commercially available, none have been developed specifically for and rigorously evaluated in cancer survivors. Objective: The SEAMLESS study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship –MBCS– Journey) for treating: 1) symptoms of stress (primary outcome), as well as; 2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). Additionally, the study aims to assess associations between psycho-biometric data collected by the smartphone app with self-reported outcome data from validated psychometric scales. This is the first efficacy trial of a tailored mindfulness app intervention in cancer survivors. Methods: The study design is a randomized wait-list controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all treatments for a minimum of 2 weeks. Outcomes will be assessed online using validated psychometric instruments delivered through the Research Electronic Data Capture (REDCap) survey software at: 1) baseline; 2) mid-intervention (2 weeks later); 3) immediately post-intervention (4 weeks); 4, 5 & 6) at 3, 6 and12 months’ post-baseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. Additionally, data will be obtained by the smartphone app itself, which includes users’ engagement with the app-based intervention, their emotional state (e.g. angry, elated) from a user-inputted digital emotion-mapping board, and heart-rate data through algorithms that analyze facial bio-signals using photoplethysmography technology. Results: The study received ethics approval in September, 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome will be complete by September, 2019, and follow-up data will be complete by May, 2020. Data will be analyzed to determine group differences using Linear Mixed Modelling statistical techniques. Conclusions: Cancer-care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today’s digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made easily available for psychosocial care at cancer centers worldwide.

  • Tackling Research Inefficiency in Degenerative Cervical Myelopathy: illustrating the current challenges for research synthesis

    Date Submitted: Aug 19, 2019

    Open Peer Review Period: Aug 19, 2019 - Oct 14, 2019

    Background: Degenerative cervical myelopathy (DCM) is widely accepted as the most common cause of adult myelopathy worldwide. Despite this, there remains no specific term or diagnostic criteria in the...

    Background: Degenerative cervical myelopathy (DCM) is widely accepted as the most common cause of adult myelopathy worldwide. Despite this, there remains no specific term or diagnostic criteria in the ICD-11 and no medical subject headings (MeSH) or equivalent in common literature databases. This makes searching the literature and thus, conducting systematic reviews and/or meta-analyses (SR/MA) imprecise and inefficient. Efficient research synthesis is integral to delivering evidence-based medicine and improving research efficiency. Objective: This study sought to illustrate the difficulties encountered when attempting to carry out comprehensive and accurate evidence search in the field of DCM, by identifying the key sources of imprecision and quantifying their impact. Methods: In order to identify the key sources of imprecision and quantify their impact, an illustrative search strategy was formed using a validated DCM HEDGE combined together with contemporary strategies used by authors in previous SR/MA. This strategy was applied to MEDLINE and EMBASE databases, looking for relevant DCM SR/MA published within the last 5 years. Results: The MEDLINE via PubMed search strategy (Figure 1) returned 24,166 results, refined to 534 after application of inclusion and exclusion criteria. 176 (32.96%) results were about DCM, 97 (18.16%) of these were DCM SR/MA (Table 1). Non-DCM results were organized into imprecision categories (spinal 50.2%, non-spinal 15.5%, non-human 1.5%). The largest categories were spinal cord injury (13.67%), spinal neoplasms (8.24%), infectious diseases of the spine and CNS (3.37%) and other spinal levels (thoracic, lumbar, sacral) (3.37%). Counterintuitively, the use of “human” and “adult” PubMed filters was found to exclude a large number of relevant articles. Searching a second database (EMBASE), added an extra 12 DCM SR/MA articles. Conclusions: DCM search strategies face significant imprecision, principally due to overlapping and heterogenous search terms, and inaccurate article indexing. Notably common employed MEDLINE filters, ‘Human’ and ‘Adult’ reduced search sensitivity, whereas the related articles function and use of a second database (EMBASE) improved it. Development of a MeSH labelling and a standardized DCM definition would allow comprehensive and specific indexing of DCM literature. This is required to support a more efficient research synthesis.

  • Geriatric Trauma – a rising tide. Assessing Patient Safety challenges in a vulnerable population. The GTAPS project protocol

    Date Submitted: Aug 13, 2019

    Open Peer Review Period: Aug 13, 2019 - Oct 8, 2019

    Background: Many high- and-middle-income countries around the world are experiencing historic demographical changes: People are living longer, birth rates are decreasing, and older people constitute a...

    Background: Many high- and-middle-income countries around the world are experiencing historic demographical changes: People are living longer, birth rates are decreasing, and older people constitute a growing proportion of the population. This contributes to increasing numbers of geriatric trauma patients. Geriatric patients have higher mortality rates after injury than younger patients, and many characteristics of geriatric patients are risk factors for a poor outcome after trauma, such as high age, pre-existing medical conditions, anticoagulant use, frailty and altered physiological response to trauma. While younger patients are more often injured in high-energy trauma, older patients are more often injured in low-energy trauma, e.g. same-level falls, from which they can sustain severe injury. Despite these differences most trauma systems use the same triage tools for all adults, and the elderly are found to have a high risk of undertriage. Due to the inherent risk-factors of a poor outcome and the fact that trauma systems are not sensitive enough to address these challenges, the geriatric trauma patients are vulnerable. These factors suggest that there might be a patient safety risk for geriatric trauma patients built-in to the Norwegian national trauma system. The way health personnel and trauma systems handle geriatric trauma is only partially explored. Our aim is to assess if patient safety challenges exist for Norwegian geriatric trauma patients, to identify risk areas, and to explore differences in trauma care given to young and elderly trauma patients. This knowledge will contribute to the improvement of trauma care given to the most rapidly increasing population segment in developed countries. Inherent trauma system challenges and patient risk factors might not be the only factors contributing to geriatric trauma outcomes. Questions have been raised about whether negative attitudes towards the elderly – ageism – might contribute to their disproportionately negative outcomes. There is a possibility that expectations of poorer outcomes lead to passive, observational roles and low treatment ambitions, which can create a self-fulfilling prophecy of bad outcomes. This dilemma will be addressed in this project. Objective: The aim of this project is to investigate whether patient safety challenges exist for older trauma patients in Norway. An important objective of the study is to identify risk areas that will facilitate further work to safeguard and promote quality and safety in the Norwegian trauma system. Methods: This is planned as a PhD-project divided into four parts: Three registry-based studies and one qualitative focus group study. By supplementing registry data from the Norwegian Trauma Registry (NTR) with focus group interviews with personnel in the emergency chain we will provide new knowledge about the treatment of geriatric trauma patients, knowledge that due to international trauma system similarities might be transferrable to international trauma systems. Results: The project has received funding from January 2019 through December 2021, and it is approved by the Data Protection Officer responsible for the Norwegian Trauma Registry. An application for access to registry data has been submitted and is pending. Results will be ready for publication from spring 2020. Conclusions: This project is the first step toward increased knowledge about trauma in Norwegian geriatric patients on a national level and will form the basis for further research aiming at interventions that eventually will make the trauma system better equipped to meet the rising tide of geriatric trauma.

  • Exploring drivers of work-related psychological stress in general practice teams as an example for small and medium-sized enterprises – a study protocol for an integrated ethnographic approach of social research methods

    Date Submitted: Aug 9, 2019

    Open Peer Review Period: Aug 8, 2019 - Oct 3, 2019

    Background: An increasing shortage of skilled (medical) personnel has been reported in many post-industrial economies. Concerning are persisting and growing trends in absenteeism and an incapacity to...

    Background: An increasing shortage of skilled (medical) personnel has been reported in many post-industrial economies. Concerning are persisting and growing trends in absenteeism and an incapacity to work which has initiated a political, economic and scientific interest in a better understanding and management of determinants related to work environment and health. Objective: This study protocol describes an integrated approach of social research methods to explore work-related determinants of psychological stress in primary care teams as an example for micro-, small and medium-sized enterprises (SMEs). Methods: The methods applied will allow an in-depth exploration of work practices and experiences in relation to psychological well-being in general practice teams. To develop an in-depth understanding of drivers of work-related psychological stress in general practice teams, an ethnographic approach will be pursued. We will combine participating observation and individual interviews with five to seven general practitioners (GP), and five to seven focus group discussions with the non-physician staff (3 - 4 participants per group) in four GP group practices and one single practice in Germany. Data collection as well as analysis follows a grounded theory approach. Results: The Ethics Committee of the Medical Faculty and University Hospital of Tuebingen has approved of this study (reference number: 640/2017BO2). Recruitment has commenced with study completion anticipated in mid-2020. Conclusions: The data from this project will be used in follow-up projects to develop and test an intervention to reduce and prevent psychological stress in GP practices and other SMEs.

  • Gamified mobile computerized cognitive behavioral therapy for Japanese university students with depressive symptom: A study protocol of a randomized controlled trial

    Date Submitted: Aug 5, 2019

    Open Peer Review Period: Aug 6, 2019 - Oct 1, 2019

    Background: Evidence shows that computerized self-help interventions are effective for reducing symptoms for depression. One such intervention, a gamified computerized cognitive behavioral therapy (cC...

    Background: Evidence shows that computerized self-help interventions are effective for reducing symptoms for depression. One such intervention, a gamified computerized cognitive behavioral therapy (cCBT), called SPARX, was developed for adolescents in New Zealand and shown to be no less effective than usual care for young people with mild to moderate symptoms of depression. However, this approach has not been previously tested in Japan. Objective: This trial is designed to investigate whether a Japanese-adapted version of SPARX improves depressive symptoms in Japanese university students with mild to moderate depressive symptoms. Methods: In this 7-week, multicenter, stratified, parallel-group superiority randomized trial, participants are allocated to either a treatment condition (SPARX) or a wait-list control condition. SPARX is delivered on their mobile phone or tablet device. Participants in a treatment condition use the SPARX program weekly. The primary outcome is the reduction of depressive symptoms (using the Patient Health Questionnaires-9) and is measured at baseline, weekly throughout the intervention, after the seven-week intervention, and at one month follow-up. Secondary outcomes include satisfaction with the program and satisfaction with life as measured by the Satisfaction With Life Scale, positive and negative moods as measured by the Profile of Mood States Second Edition, social functioning as measured by the EuroQol Instrument, rumination as measured by the Ruminative Responses Scale, and coping as measured by the Brief Coping Orientation to Problem Experienced Inventory. Results: This study recdeived funding from The Research Institute of Personalized Health Sciences, Health Sciences University of Hokkaido and obtained institutional review board approval in September 2019, and began data collection in April 2019. Conclusions: Results of this trial may provide further evidence for the efficacy of gamified cCBT for the treatment of depression and, specifically, provide support for using SPARX for Japanese university students. Clinical Trial: UMIN000034354 (registered on 3 October, 2018, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000039164)

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