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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:

  • 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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    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...

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    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

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    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

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    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

  • Source: Flickr; Copyright: World Bank Photo Collection; URL: https://www.flickr.com/photos/worldbank/9157184495/in/photolist-eXbXVi-9S4Znk-c6JPFJ-bZ4QJo-5kX4uA-nCQSRG-cimkkW-47pZp7-5Z5ran-8gDbD5-8gzV6g-7pQAZr-ifoAk2-9S7UpN-oPr4Cp-e1m4m2-8gDbLs-5WxfmL-5yAXxw-nannTd-6i5tSv-x12YJg-pVVqzD-pcAwgR-bvXpoG-7iuxt7-oUdtNu-pa; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).
    RCTs - Protocols/Proposals (eHealth)

    Aug 15, 2019

    Mental Health Promotion Among University Students Using Text Messaging: Protocol for a Randomized Controlled Trial of a Mobile Phone–Based Intervention

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    Background: There is a growing understanding that well-being and mental illness are 2 separate dimensions of mental health. High well-being is associated with decreased risk of disease and mental illness and increased longevity. Objective: This study aims to test the efficacy of a mobile phone–based intervention on positive mental health. Methods: We are conducting a 2-armed randomized controlled trial of university students in Sweden. Recruitment will last for 6 months by digital advertising (eg, university websites). Participants will be randomly allocated to either an intervention (fully automated mobile phone–based mental health intervention) or control group (treatment as usual). The primary outcome will be self-assessed positive mental health (Mental Health Continuum Short Form). Secondary outcomes will be self-assessed depression anxiety symptomatology (Hospital Anxiety Depression Scale). Outcomes will be investigated at baseline, at 3, 6, and 12 months after randomization. Mediators (positive emotions and thoughts) will be investigated at baseline, midintervention, and at follow-ups using 2 single face-valid items. Results: Data will be collected between autumn 2018 and spring 2019. Results are expected to be published in 2020. Conclusions: Strengths of the study include the use of a validated comprehensive instrument to measure positive mental health. Mechanisms of change are also investigated. A potential challenge could be recruitment; however, by setting a prolonged recruitment period, we believe that the study will recruit a sufficient sample. Trial Registration: International Standard Randomized Controlled Trial Number: 54748632; http://www.isrctn.com/ ISRCTN54748632 International Registered Report Identifier (IRRID): PRR1-10.2196/12396

  • Father and son. Source: Shutterstock; Copyright: George Rudy; URL: https://www.shutterstock.com/image-photo/father-son-using-digital-tablets-smiling-523948423?studio=1; License: Licensed by the authors.
    RCTs - Protocols/Proposals (funded,...

    Aug 14, 2019

    A Mobile App to Support Parents Making Child Mental Health Decisions: Protocol for a Feasibility Cluster Randomized Controlled Trial

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    Background: Shared decision making (SDM) is recognized as a person-centered approach to improving health care quality and outcomes. Few digital interventions to improve SDM have been tested in child and adolescent mental health (CAMH) settings. One such intervention is Power Up, a mobile phone app for young people (YP), which has shown some evidence of promise that YP who received Power Up reported greater levels of SDM. However, even though parents play a critical role in CAMH care and treatment, they often feel excluded from services. Objective: This protocol is for a pilot trial to determine the feasibility of a large-scale randomized trial to develop and evaluate a Web app called Power Up for Parents (PUfP) to support parents and promote involvement in CAMH decisions. Methods: A 2-stage process, consisting of the development stage and pilot-testing stage of the initial PUfP prototype, will be conducted. At the development stage, a qualitative study with parents and clinicians will be conducted. The interviews will aim to capture the experience of making CAMH decisions, preferences for involvement in SDM, and determine situations within which PUfP can be useful. At the pilot-testing stage, up to 90 parents and their clinicians will be invited to participate in the testing of the prototype. Parents will be randomly allocated to receive the intervention or be part of the control group. This study design will allow us to assess the acceptability and usefulness of PUfP in addition to examining the feasibility of a prospective randomized trial. Clinicians’ perceptions of the prototype and how it has influenced parents’ involvement in SDM will also be examined. Results: Recruitment began in January 2019 and is scheduled to last for 10 months. Interviews and baseline data collection are currently in progress. To date, 11 CAMH sites have been recruited to take part in the study. It is anticipated that data collection will be completed by October 2019. Conclusions: The lack of parents’ involvement in CAMH care and treatment can lead to higher rates of dropout from care and lower adherence to therapeutic interventions. There are significant benefits to be gained globally if digital SDM interventions are adopted by parents and shown to be successful in CAMH settings. Trial Registration: ISRCTN Registry ISRCTN39238984; http://www.isrctn.com/ISRCTN39238984 International Registered Report Identifier (IRRID): DERR1-10.2196/14571

  • Source: Unsplash; Copyright: Matthew Bennett; URL: https://unsplash.com/photos/78hTqvjYMS4; License: Licensed by JMIR.
    Non-Randomized Studies (funded,...

    Aug 14, 2019

    Exploring Existential Loneliness Among Frail Older People as a Basis for an Intervention: Protocol for the Development Phase of the LONE Study

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    Background: International research concerning end-of-life issues emphasizes the importance of health care professionals (HCPs) being prepared to deal with existential aspects, like loneliness, in order to provide adequate care. The last phase of life is often related to losses of different kinds, which might trigger feelings of isolation in general and existential loneliness (EL) in particular. There is a large body of research concerning loneliness among older people in general, but little is known about the phenomenon and concept of EL in old age. Objective: This study aims to describe the framing, design, and first results of the exploratory phase of an intervention study focusing on EL among older people: the LONE study. This stage of the study corresponds to the development phase, according to the Medical Research Council framework for designing complex interventions. Methods: The LONE study contains both theoretical and empirical studies concerning: (1) identifying the evidence base; (2) identifying and developing theory through individual and focus group interviews with frail older people, significant others, and HCPs; and (3) modeling process and outcomes for the intervention. This project involves sensitive issues that must be carefully reviewed. The topic in itself concerns a sensitive matter and the study group is vulnerable, therefore, an ethical consciousness will be applied throughout the project. Results: The results so far show that EL means being disconnected from life and implies a feeling of being fundamentally separated from others and the world, whether or not one has family, friends, or other close acquaintances. Although significant others highlighted things such as lack of activities, not participating in a social environment, and giving up on life as aspects of EL, the older people themselves highlighted a sense of meaningless waiting, a longing for a deeper connectedness, and restricted freedom as their origins of EL. The views of HCPs on the origin of EL, the place of care, and their own role differed between contexts. Conclusions: The studies focusing on identifying the evidence base and developing theory are published. These results will now be used to identify potential intervention components, barriers, and enablers for the implementation of an intervention aimed at supporting HCPs in encountering EL among older people. International Registered Report Identifier (IRRID): RR1-10.2196/13607

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/8/e14636/; License: Creative Commons Attribution (CC-BY).
    Non-Randomized Study Protocols and...

    Aug 12, 2019

    Safety and Efficacy of Bis-Glyceryl Ascorbate (Amitose DGA) to Prevent Hand-Foot Skin Reaction in Patients With Renal Cell Carcinoma Receiving Sunitinib...

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    Background: Hand-foot skin reaction (HFSR) is a serious side effect induced by multiple-tyrosine kinase inhibitors (TKIs). HFSR can cause treatment interruption or decreased dosing. HFSR also markedly decreases quality of life and is associated with the therapeutic efficacy of multiple-TKIs. Therefore, the management and prevention of HFSR is an important issue; however, an effective method for its prevention has not been established. Specific ascorbic acid derivatives can reverse multiple-TKI-induced keratinocyte growth and pathological changes in vitro. Objective: This study was designed to evaluate the safety of bis-glyceryl ascorbate (Amitose DGA), a novel, hydrosoluble, and moisturizing ascorbic acid derivative, in patients with renal cell carcinoma (RCC) receiving sunitinib therapy. This study was also designed to evaluate Amitose DGA’s preventive efficacy for sunitinib-induced HFSR. Methods: This is a Phase I/II, single-center, uncontrolled, single-arm, open-label trial. We will recruit a total of 30 patients with RCC receiving sunitinib therapy, with a 2-week-on and 1-week-off schedule. The participants will apply Amitose DGA-containing cream over both palmar and plantar surfaces within two treatment cycles (ie, 6 weeks) of sunitinib in combination with a general moisturizing agent, in addition to standard-of-care processes. Safety assessments will include dermatological abnormalities, clinical laboratory tests, and incidence of adverse events. Efficacy assessments will include development of HFSR and therapeutic outcomes associated with sunitinib. Results: Recruitment to the study began in August 2017 and is ongoing in Japan. To date, 21 subjects have been recruited. Study completion is expected in 2021. Conclusions: This is the first clinical study of Amitose DGA-containing cream in patients with RCC who are receiving sunitinib therapy. The single-center, single-arm, open-label design was selected to maximize subject exposure and increase the likelihood of achieving our study endpoints. The results will provide valuable and preliminary evidence of the effects of Amitose DGA-containing cream on HFSR. Trial Registration: UMIN Clinical Trials Registry UMIN000027209; https://upload.umin.ac.jp/cgi-open-bin/ctr /ctr_view.cgi?recptno=R000031174 International Registered Report Identifier (IRRID): DERR1-10.2196/14636

  • The SIRUPP project. Source: Jesus Calle Romero; Copyright: Jesus Calle Romero; URL: http://www.researchprotocols.org/2019/8/e13701/; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).
    Non-Randomized Studies (funded,...

    Aug 12, 2019

    Monitoring Immobilized Elderly Patients Using a Public Provider Online System for Pressure Ulcer Information and Registration (SIRUPP): Protocol for a Health...

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    Background: Pressure ulcers represent a major challenge to patient safety in the health care context, presenting high incidence (from 7% to 14% in Spain) and increased financial costs (€400-600 million/year) in medical treatment. Moreover, they are a significant predictor of mortality. The prevention of pressure ulcers in long-term care centers and patients’ own homes is proposed as a priority indicator of health care quality. Early stage risk assessment and database recording are both crucial aspects of prevention, classification, diagnosis, and treatment. Objective: This project proposes a 3-year study of immobilized patients residing in the Granada-Metropolitan Primary Healthcare District (DSGM) and monitored via the Pressure Ulcer Information and Registration System (SIRUPP, Spanish initials). The project aims to estimate the incidence of PUs among immobilized elderly patients, analyze the health-related quality of life of these patients by using the Pressure Ulcer Quality of Life (PU-QoL) instrument in a sample of 250 patients, determine the average time to complete wound healing, estimate the rate of pressure ulcers–associated mortality, and assess the predictive value of the Braden and Mini Nutritional Assessment risk measurement scales in a sample of 1700 patients. Methods: The DSGM runs SIRUPP, which is linked to patients’ electronic health records. Currently, 17,104 immobilized patients are monitored under this system. Health-related quality of life will be measured by patient self-reports using the Spanish Pressure Ulcer Quality of Life questionnaire, following cross-cultural adaptation and psychometric validation with respect to the English-language version. Results: The project commenced in June 2017 and is expected to conclude in April 2020. Conclusions: This study addresses two main health outcomes—the time needed for wound healing and the mortality associated with pressure ulcers—both of which might be accounted for by variations in clinical practice and the health-related quality of life of patients with pressure ulcers. International Registered Report Identifier (IRRID): DERR1-10.2196/13701

  • Blood test for serum biomarkers of aortic stenosis in patients with diabetes. Source: FreeImages.com; Copyright: Billy W; URL: https://www.freeimages.com/photo/blood-test-1545982; License: Licensed by the authors.
    Non-Randomized Study Protocols and...

    Aug 12, 2019

    Aortic Stenosis Prognostication in Patients With Type 2 Diabetes: Protocol for Testing and Validation of a Biomarker-Derived Scoring System

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    Background: Type 2 diabetes mellitus (T2DM) has been established as an important independent risk factor for aortic stenosis. T2DM patients present with a higher degree of valve calcification and left ventricular dysfunction compared to patients without diabetes. This may be due to an increase in incidence and severity of myocardial fibrosis. Currently, there is no reliable method of determining the optimal timing of intervention for a patient with asymptomatic aortic stenosis or predicting when a patient will become symptomatic. Research into serum biomarkers to predict subclinical onset and track progression of aortic stenosis is hampered by the multimodal nature of the pathological processes ultimately responsible for aortic stenosis. Objective: The aim of this study is to prove that an approach using a combination of serum biomarkers and the echocardiographic parameter global longitudinal strain (GLS) can be used to establish baseline status of fibrocalcific aortic valve disease, predict rate of progression, and quantitatively assess any regression of these processes following aortic valve replacement in patients with T2DM. Methods: Validated serum biomarkers for the separate processes of calcification, inflammation, oxidative stress and fibrosis can be used to quantify onset and rate of progression of aortic stenosis. This, in combination with the echocardiographic parameter GLS, can be compared with other objective investigations of calcification and fibrosis with the aim of developing a quick, noninvasive one-stop assessment of aortic stenosis in patients with T2DM. The serum biomarkers BNP (B-type natriuretic peptide), Gal-3 (Galectin-3), GDF-15 (growth differentiation factor-15), sST2 (soluble suppression of tumorigenicity 2), OPG (osteoprotegerin), and microRNA 19b and 21 will be sampled from patients undergoing aortic valve replacement (with and without T2DM), patients with T2DM but without aortic valve disease and healthy volunteers. These patients will also undergo computed tomography (CT) scans for calcium scoring, magnetic resonance imaging (MRI) to quantify myocardial fibrosis, and myocardial strain imaging with speckle-tracking echocardiography. Samples of calcified native aortic valve and a biopsy of ventricular myocardium will be examined histologically to determine the quantity and distribution of calcification and fibrosis, and the secretome of these tissue samples will also be analyzed for levels of the same biomarkers as in the serum samples. All patients will be followed up with in 3 months and 12 months for repeat blood sampling, echocardiography, and CT and MRI imaging to assess disease progression or regression. The results of tissue analysis and CT and MRI scanning will be used to validate the findings of the serum biomarkers and echocardiographic assessment. Results: Using all of the information gathered throughout the study will yield a ranking scale for use in the clinic, which will provide each patient with a fibrocalcific profile. This can then be used to recommend an optimal time for intervention. Conclusion: A reliable, validated set of serum biomarkers combined with an inexpensive bedside echocardiographic examination can now form the basis of a one-stop outpatient-based assessment service, which will provide an accurate risk assessment in patients with aortic stenosis at first contact. International Registered Report Identifier (IRRID): PRR1-10.2196/13186

  • Integration. Source: iStock by Getty Images; Copyright: pixelfit; URL: https://www.istockphoto.com/gb/photo/sea-of-hands-gm857146092-141264513; License: Licensed by the authors.
    RCTs - Protocols/Proposals (non-eHealth)

    Aug 9, 2019

    Evaluation of a Collaborative Protocolized Approach by Community Pharmacists and General Medical Practitioners for an Australian Minor Ailments Scheme:...

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    Background: Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MASs) promote efficiencies within the health care system. The cost savings and health outcomes demonstrated in the United Kingdom and Canada open up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. Objective: This trial aims to evaluate the clinical, economic, and humanistic impact of an Australian Minor Ailments Service (AMAS) compared with usual pharmacy care in a cluster randomized controlled trial (cRCT) in Western Sydney, Australia. Methods: The cRCT design has an intervention group and a control group, comparing individuals receiving a structured intervention (AMAS) with those receiving usual care for specific health ailments. Participants will be community pharmacies, general practices, and patients located in Western Sydney Primary Health Network (WSPHN) region. A total of 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments: reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhea, or low back pain. Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The coprimary outcomes are rates of appropriate recommendation of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, health services resource utilization, and EuroQoL Visual Analogue Scale. Differences in primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost-utility and cost-effectiveness analysis compared with usual care. Results: The study began in July 2018. Thirty community pharmacies were recruited. Pharmacists from the 15 intervention pharmacies were trained. A total of 27 general practices consented. Pharmacy patient recruitment began in August 2018 and was completed on March 31, 2019. Conclusions: This study may demonstrate the efficacy of a protocolized intervention to manage minor ailments in the community and will assess the clinical, economic, and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and appropriate self-medication may contribute to greater efficiency of health care resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a national MAS service in Australia, using a robust framework for management and referral for common ailments. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000286246; http://www.anzctr.org.au/ACTRN12618000286246.aspx International Registered Report Identifier (IRRID): DERR1-10.2196/13973

  • Source: Shutterstock; Copyright: Photographee.eu; URL: https://www.shutterstock.com/image-photo/high-angle-group-teenagers-sitting-circle-1130133704?src=ctOh1sIwUp1cwJn4CqYahg-4-40; License: Licensed by the authors.
    Non-Randomized Study Protocols and...

    Aug 9, 2019

    Family Members’ Perspectives of Health Care System Interactions With Suicidal Patients and Responses to Suicides: Protocol for a Qualitative Research Study

    Authors List:

    Abstract:

    Background: Suicide is a major cause of preventable death globally and a leading cause of death by injury in Canada. To support people who experience suicidal thoughts and behaviors and ultimately prevent people from dying by suicide, it is important to understand the individual and familial experiences with the health care system. Objective: This study aims to explore how suicide victims, and their family members, interacted with the health care system. Methods: We will invite family members of 6 to 8 suicide victims to participate in the study by sharing their perspectives on both their relative’s as well as their own interactions with the health care system. Interviews will take place in-person and will be audio recorded, transcribed, and analyzed thematically. Results: The results of the study are expected to be available in 12 months. We expect the results to shed light on the experiences of suicide victims and their family members with the health care system. Conclusions: Our study results may inform practice, policy, and further research. They may shape how members of the health care system respond to people who are at risk of suicide and their families. International Registered Report Identifier (IRRID): PRR1-10.2196/13797

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  • 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.

  • An e-Delphi study protocol to develop an evidence-based nursing handover standard for a multi-site public hospital in Switzerland

    Date Submitted: Aug 17, 2019

    Open Peer Review Period: Aug 17, 2019 - Aug 26, 2019

    Background: Inadequate or non-existent clinical handovers, or failures to transfer information, responsibility, and accountability can have extremely serious consequences for hospitalized patients. Ob...

    Background: Inadequate or non-existent clinical handovers, or failures to transfer information, responsibility, and accountability can have extremely serious consequences for hospitalized patients. Objective: To build a consensus, evidence-based, nursing handover standard for inpatients during shift changes or internal transfers between hospital wards and based on the papers by Slade et al. (2014, 2016). Methods: This protocol describes a mixed-methods design using a modified Delphi data-collection survey and involving a targeted panel sample of about 300 nurse experts. A multi-round survey will select this quasi-anonymized panel from a multi-site public hospital in Switzerland. Each survey stage will be described and will build on the previous one. The study will end with a cognitive debriefing involving a focus group discussion with a randomly selected panel deciding on which items should and should not be accepted for the evidence-based clinical nursing handover standard. An item must achieve a consensus of ≥ 70% for inclusion. Results: The present study’s expected outcome is a consensus-built, evidence-based nursing handover standard for inpatients during shift changes or internal transfers between the wards of a multi-site public hospital in Switzerland. The first round’s expected outcomes will be the selection of numerous items about which the panel was in agreement and a list of items about which it could not find a consensus. The second round’s expected outcomes will be a final selection of the items about which the panel was in agreement and a list of items about which no agreement could be found (i.e., topics rejected for inclusion in the handover standard). The third round of the e-Delphi process will be a cognitive debriefing involving a focus group discussing the consensus/non-consensus items in the nursing shift handover and patient transfer standard. Conclusions: This survey will enable us to develop an evidence-based nursing handover standard for use during shift changes and internal inpatient transfers in a multi-site public hospital in Switzerland. Clinical Trial: not applicable

  • 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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