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JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results


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.

JMIR Res Protoc is a journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (JMIR Impact Factor 2016: 5.175).

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 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 proposal 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).

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


Recent Articles:

  • Source: Joint Base Langley-Eustis; Copyright: US Air Force (Brian Ybarbo); URL:; License: Public Domain (CC0).

    Symptomatic Treatment of Vascular Cognitive Impairment (STREAM-VCI): Protocol for a Cross-Over Trial


    Background: People with vascular cognitive impairment (VCI) constitute a clinically heterogeneous group, but previous symptomatic drug trials in VCI did not take this clinical heterogeneity into account. Executive dysfunction and memory impairment are the cognitive domains that are most frequently impaired in VCI, and these impairments are likely to reflect vascular damage to specific neurotransmitter systems, which opens the possibility for targeted symptomatic treatment directed at specific neurotransmitters. Objective: Here we describe the design of the “Symptomatic Treatment of Vascular Cognitive Impairment” (STREAM-VCI) trial. In this proof-of-concept study, we investigate whether people with VCI with executive dysfunction due to vascular damage to the monoaminergic neurotransmitter system differentially respond to a monoaminergic challenge, whereas people with VCI with memory dysfunction associated with vascular damage to the cholinergic system will in turn respond to a cholinergic challenge. Methods: The STREAM-VCI is a single center, double blind, three-way cross-over trial among 30 people with VCI, in which subjects received a single dose of galantamine, methylphenidate, or placebo on separate occasions. The most important inclusion criteria were a diagnosis of VCI with a Mini-Mental State Examination score of ≥16 and a Clinical Dementia Rating of 0.5-1.0. For each person, the challenges consisted of a single 16 mg dose of galantamine, 10 mg of methylphenidate, and placebo, in random order on three separate visits. Change in performance in executive functioning and memory was assessed directly after the challenge using standardized neuropsychological tests. We will correlate a positive response to the cholinergic and monoaminergic treatment with differences in structural and functional connectivity at baseline using structural magnetic resonance imaging (MRI), diffusion tension MRI, and resting-state functional MRI. Results: The protocol of this study is approved by the Medical Ethics Committee of VU University Medical Center and the competent authority. The first participant was enrolled in April 2014. In September 2017, enrolment for the study was completed. We expect to publish the results in 2018. Conclusions: STREAM-VCI is the first study to investigate the association of a response to a cholinergic and monoaminergic treatment with structural and functional connectivity of the monoaminergic and/or cholinergic systems on MRI. We aim to predict on an individual basis which individuals show a positive response to a cholinergic and/or monoaminergic challenge in people with VCI. This may be instrumental in moving in the direction of individually-tailored pharmacological interventions based on MRI measures in people with VCI. Trial Registration: NCT02098824; (Archived by WebCite at

  • Source:; Copyright: Javier Sánchez Mingorance; URL:; License: Creative Commons Attribution (CC-BY).

    Assessing the Feasibility of a Social Media to Promote Weight Management Engagement in Adolescents with Severe Obesity: Pilot Study


    Background: Severe obesity in adolescents has deleterious physical and psychological complications necessitating frequent multi-disciplinary clinic visits. Greater treatment engagement has been equated with weight-loss. However, traditional medical weight-loss programs for adolescents have high attrition rates. Social media is widely used by adolescents and may enhance medical weight management engagement and success. Objective: The first objective was to examine the acceptability and feasibility of using a private social media group as an adjunct to medical weight management in youth ages 14 to 20 years with severe obesity [body mass index (BMI) ≥ 35 kg/m2]. The second objective was to pilot test the use of social media to improve treatment engagement and decrease attrition rates. Methods: In this single arm, 12 week pre-post study, participants attended individual clinic visits and participated in a moderated private social media group that received nutrition, exercise, and behavior change social media communications or “posts” 3 to 4 times/week. Youth commented and/or liked posts from the moderator and each other. Social media engagement was measured with the number of likes and comments on social media. Clinic attrition was compared, measuring clinic visit attendance 12 weeks prior, during, and after the intervention with mixed linear regression models. Correlations of social media engagement with changes from baseline for BMI, BMI-z score, and psychosocial measures were fit. Results: All 13 enrolled youth completed the study and reported that the group was enjoyable, helpful, reinforced their weight management program, and would recommend using social media to support other youth. The pilot trial was acceptable and feasible. Youth mean weekly engagement (likes + comments) in social media was greater than once a day (8.6 ±3.6). Compared to 12 weeks prior to the intervention, there was no significant decrease in clinic visit attendance at the end of the intervention (M=.231, P=.69) or 12 weeks at the conclusion of the intervention (M=.589, P=.28). Increased social media comments correlated with weight change (r=–.633, P=.04). Conclusions: This pilot trial demonstrated that the use of social media as an adjunct to medical weight management was feasible and acceptable to adolescents with severe obesity. Based upon these preliminary findings, social media may be an effective way to mitigate attrition from obesity treatment programs, and improve health outcomes in this high-risk population.

  • Source: Image created by the Authors; Copyright: The Authors; URL:; License: Licensed by JMIR.

    Evaluation of Technology-Based Peer Support Intervention Program for Preventing Postnatal Depression: Protocol for a Randomized Controlled Trial


    Background: Multiple international agencies, including the World Health Organization and the International Monetary Fund, have emphasized the importance of maternal mental health for optimal child health and development. Adequate social support is vital for the most vulnerable to postpartum mood disorders. Hence, an urgent need for sustainable social support programs to aid mothers ease into their new parenting role exists. Objective: This study protocol aims to examine the effectiveness of a technology-based peer support intervention program among mothers at risk for postnatal depression in the early postpartum period. Methods: A randomized controlled 2-group pretest and repeated posttest experimental design will be used. The study will recruit 118 mothers from the postnatal wards of a tertiary public hospital in Singapore. Eligible mothers will be randomly allocated to receive either the peer support intervention program or routine perinatal care from the hospital. Peer volunteers will be mothers who have experienced self-reported depression and will be receiving face-to-face training to support new mothers at risk of depression. Outcome measures include postnatal depression, anxiety, loneliness, and social support. Data will be collected at immediate postnatal period (day of discharge from the hospital), at fourth week and twelfth week post childbirth. Results: The recruitment and training of peer support volunteers (N=20) ended in June 2017, whereas recruitment of study participants commenced in July 2017 and is still ongoing. The current recruitment for new mothers stands at 73, with 36 in the control group and 37 in the intervention group. Data collection is projected to be completed by May 2018. Conclusions: This study will identify a potentially effective and clinically useful method to prevent postnatal depression in new mothers, which is the top cause of maternal morbidity. Receiving social support from others who share similar experiences may enhance the positive parenting experiences of mothers, which in turn can improve the psychosocial well-being of the mothers, tighten mother-child bond, and enhance overall family dynamics for mothers and infants. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN14864807; (Archived by WebCite at

  • Study logo. Source: The Authors; Copyright: Evan O'Neil; URL:; License: Licensed by the authors.

    Strengths-Based Behavioral Intervention for Parents of Adolescents With Type 1 Diabetes Using an mHealth App (Type 1 Doing Well): Protocol for a Pilot...


    Background: Supportive parent involvement for adolescents’ type 1 diabetes (T1D) self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative family teamwork. Few interventions have used explicitly strengths-based approaches to help reinforce desired management behaviors and promote positive family interactions around diabetes care. Objective: The aim of this protocol was to describe the development of a new, strengths-based behavioral intervention for parents of adolescents with T1D delivered via a mobile-friendly Web app called Type 1 Doing Well. Methods: Ten adolescent-parent dyads and 5 diabetes care providers participated in a series of qualitative interviews to inform the design of the app. The 3- to 4-month pilot intervention will involve 82 parents receiving daily prompts to use the app, in which they will mark the diabetes-related strength behaviors (ie, positive attitudes or behaviors related to living with or managing T1D) their teen engaged in that day. Parents will also receive training on how to observe diabetes strengths and how to offer teen-friendly praise via the app. Each week, the app will generate a summary of the teen’s most frequent strengths from the previous week based on parent reports, and parents will be encouraged to praise their teen either in person or from a library of reinforcing text messages (short message service, SMS). Results: The major outcomes of this pilot study will include intervention feasibility and satisfaction data. Clinical and behavioral outcomes will include glycemic control, regimen adherence, family relationships and conflict, diabetes burden, and health-related quality of life. Conclusions: This strengths-based, mobile health (mHealth) intervention aims to help parents increase their awareness of and efforts to support their adolescents’ engagement in positive diabetes-related behaviors. If efficacious, this intervention has the potential to reduce the risk of family conflict, enhance collaborative family teamwork, and ultimately improve diabetes outcomes. Trial Registration: NCT02877680; (Archived by WebCite at

  • Researcher examining a scanning electron micrograph of a Staphylococcus aureus bacteria strain (montage). Source: Wikimedia Commons /; Copyright: JMIR Publications; URL:; License: Creative Commons Attribution (CC-BY).

    Epidemiology of Surgical Site Infections With Staphylococcus aureus in Europe: Protocol for a Retrospective, Multicenter Study


    Background: Surgical site infections (SSIs) are among the most common hospital acquired infections. While the incidence of SSI in certain indicator procedures is the subject of ongoing surveillance efforts in hospitals and health care systems around the world, SSI rates vary markedly within surgical categories and are poorly represented by routinely monitored indicator procedures (eg, mastectomy or hernia surgery). Therefore, relying on indicator procedures to estimate the burden of SSI is imprecise and introduces bias as hospitals may take special precautions to achieve lower SSI rates. The most common cause of SSI is Staphylococcus aureus (S. aureus), as recently confirmed by a Europe-wide point-prevalence study conducted by the European Centre for Disease Prevention and Control (ECDC). Objective: The primary objective of this study is to determine the overall and procedure-specific incidence of S. aureus SSI in Europe. Secondary objectives are the overall and procedure-specific outcomes as well as the economic burden of S. aureus SSI in Europe. Explorative objectives are to characterize the composition of the surgical patient population and to estimate the number of patients at risk for S. aureus SSI. Methods: A retrospective, multinational, multicenter cohort study (Staphylococcus aureus Surgical Site Infection Multinational Epidemiology in Europe [SALT] study) with a nested case-control part will be conducted. The study will include all surgical procedures at a participating center in order to prevent selection bias and strengthen the understanding of SSI risk by determining the incidence for all common surgical procedures. Data will be assessed in the cohort population, including 150,000 adult patients who underwent any surgical procedure in 2016, and the case-control population. We will match patients establishing S. aureus SSI 1:1 with controls from the same center. Data on demographics, surgery, and microbiology will be exported from electronic files. More detailed data will be captured from the case-control population. The SALT study will include 13 major or academic surgical centers in Europe, comprising 3 in France, 4 in Germany, 2 in Italy, 3 in Spain, and 1 in the United Kingdom. Sites were selected using a feasibility questionnaire. Results: The SALT study is currently recruiting patients. The aim is to complete recruitment in February 2018 and to close the database in September 2018. The final results are expected by the end of 2018. Conclusions: Results of the SALT study will help to better understand the precise risk of certain procedures. They will also provide insight into the overall and procedure-specific incidence and outcome as well as the economic burden of S. aureus SSI in Europe. Findings of the study may help guide the design of clinical trials for S. aureus vaccines. Trial Registration: NCT03353532; (Archived by WebCite at

  • Source: Ramstein Air Base; Copyright: US Air Force (Leslie Keopka); URL:; License: Public Domain (CC0).

    Impact of Medication Adherence on Mortality and Cardiovascular Morbidity: Protocol for a Population-Based Cohort Study


    Background: Cardiovascular disease (CVD) is a group of disorders of the heart and blood vessels, such as coronary heart disease (CHD), cerebrovascular disease, and peripheral artery disease. CVD is the leading threat to global health, whether measured by mortality, morbidity, or economic cost. Long-term administration of aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers improves survival in patients with stablished coronary heart disease. Nevertheless, adherence to prescribed medication is poor for long-term drug treatment. Objective: We aim to assess the relationship between adherences to the four pharmacological groups recommended for secondary prevention and the clinical outcomes of cardiovascular morbidity and mortality in patients with established CHD according to the level of adherence to these drugs in a population of incident cases of acute coronary syndrome (ACS). Methods: Population-based cohort study of patients with a first episode of ACS during 2006-2015 in the Information System for Research in Primary Care (SIDIAP) database. We will estimate adherence to these drugs. The primary endpoint is a composite of all-cause mortality, ACS, and ischaemic stroke. Bivariate analyses will be performed estimating odds ratios for categorical variables and mean differences for continuous variables. Hazard ratios for adherences will be calculated for outcome events using Cox proportional hazard regression models, and proportionality of hazards assumption will be tested. Results: We expect to estimate adherence to all four study treatments, the incidence of MACE, and to analyze if this incidence is associated with the level of drug adherence. Conclusions: We expect to find that adherent patients have a lower risk of the primary endpoints compared with nonadherent patients. Trial Registration: This study protocol was classified as EPA-OD by the AEMPS (IJG-EST-2017-01-2017-01, 07/04/2017) and registered in the EU PAS register (EUPAS19017, 09/05/2017).

  • Rebecca Dewey undertaking data collection on a Philips Ingenia 3.0 T MR scanner. Source: Image created by the Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

    The Physiological Bases of Hidden Noise-Induced Hearing Loss: Protocol for a Functional Neuroimaging Study


    Background: Rodent studies indicate that noise exposure can cause permanent damage to synapses between inner hair cells and high-threshold auditory nerve fibers, without permanently altering threshold sensitivity. These demonstrations of what is commonly known as hidden hearing loss have been confirmed in several rodent species, but the implications for human hearing are unclear. Objective: Our Medical Research Council–funded program aims to address this unanswered question, by investigating functional consequences of the damage to the human peripheral and central auditory nervous system that results from cumulative lifetime noise exposure. Behavioral and neuroimaging techniques are being used in a series of parallel studies aimed at detecting hidden hearing loss in humans. The planned neuroimaging study aims to (1) identify central auditory biomarkers associated with hidden hearing loss; (2) investigate whether there are any additive contributions from tinnitus or diminished sound tolerance, which are often comorbid with hearing problems; and (3) explore the relation between subcortical functional magnetic resonance imaging (fMRI) measures and the auditory brainstem response (ABR). Methods: Individuals aged 25 to 40 years with pure tone hearing thresholds ≤20 dB hearing level over the range 500 Hz to 8 kHz and no contraindications for MRI or signs of ear disease will be recruited into the study. Lifetime noise exposure will be estimated using an in-depth structured interview. Auditory responses throughout the central auditory system will be recorded using ABR and fMRI. Analyses will focus predominantly on correlations between lifetime noise exposure and auditory response characteristics. Results: This paper reports the study protocol. The funding was awarded in July 2013. Enrollment for the study described in this protocol commenced in February 2017 and was completed in December 2017. Results are expected in 2018. Conclusions: This challenging and comprehensive study will have the potential to impact diagnostic procedures for hidden hearing loss, enabling early identification of noise-induced auditory damage via the detection of changes in central auditory processing. Consequently, this will generate the opportunity to give personalized advice regarding provision of ear defense and monitoring of further damage, thus reducing the incidence of noise-induced hearing loss.

  • Source: Wikipedia Commons; Copyright: Intuitive Surgical, Inc; URL:; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).

    Robotic Versus Open Renal Transplantation in Obese Patients: Protocol for a Cost-Benefit Markov Model Analysis


    Background: Recent studies have reported a significant decrease in wound problems and hospital stay in obese patients undergoing renal transplantation by robotic-assisted minimally invasive techniques with no difference in graft function. Objective: Due to the lack of cost-benefit studies on the use of robotic-assisted renal transplantation versus open surgical procedure, the primary aim of our study is to develop a Markov model to analyze the cost-benefit of robotic surgery versus open traditional surgery in obese patients in need of a renal transplant. Methods: Electronic searches will be conducted to identify studies comparing open renal transplantation versus robotic-assisted renal transplantation. Costs associated with the two surgical techniques will incorporate the expenses of the resources used for the operations. A decision analysis model will be developed to simulate a randomized controlled trial comparing three interventional arms: (1) continuation of renal replacement therapy for patients who are considered non-suitable candidates for renal transplantation due to obesity, (2) transplant recipients undergoing open transplant surgery, and (3) transplant patients undergoing robotic-assisted renal transplantation. TreeAge Pro 2017 R1 TreeAge Software, Williamstown, MA, USA) will be used to create a Markov model and microsimulation will be used to compare costs and benefits for the two competing surgical interventions. Results: The model will simulate a randomized controlled trial of adult obese patients affected by end-stage renal disease undergoing renal transplantation. The absorbing state of the model will be patients' death from any cause. By choosing death as the absorbing state, we will be able simulate the population of renal transplant recipients from the day of their randomization to transplant surgery or continuation on renal replacement therapy to their death and perform sensitivity analysis around patients' age at the time of randomization to determine if age is a critical variable for cost-benefit analysis or cost-effectiveness analysis comparing renal replacement therapy, robotic-assisted surgery or open renal transplant surgery. After running the model, one of the three competing strategies will result as the most cost-beneficial or cost-effective under common circumstances. To assess the robustness of the results of the model, a multivariable probabilistic sensitivity analysis will be performed by modifying the mean values and confidence intervals of key parameters with the main intent of assessing if the winning strategy is sensitive to rigorous and plausible variations of those values. Conclusions: After running the model, one of the three competing strategies will result as the most cost-beneficial or cost-effective under common circumstances. To assess the robustness of the results of the model, a multivariable probabilistic sensitivity analysis will be performed by modifying the mean values and confidence intervals of key parameters with the main intent of assessing if the winning strategy is sensitive to rigorous and plausible variations of those values.

  • Infusion pumps. Source: iStock by Getty Images; Copyright: sudok1; URL:; License: Licensed by the authors.

    Outcome of Critically ill Patients Undergoing Mandatory Insulin Therapy Compared to Usual Care Insulin Therapy: Protocol for a Pilot Randomized Controlled...


    Background: Observational and interventional studies in patients with both acute medical conditions and long-standing diabetes have shown that improved blood glucose control confers a survival advantage or reduces complication rates. Policies of “tight” glycaemic control were rapidly adopted by many general intensive care units (ICUs) worldwide in the mid 00’s, even though the results of the studies were not generalizable to mixed medical/surgical ICUs with different intravenous feeding policies. Objective: The primary objective of the study is to assess the safety of mandatory insulin infusion in critically ill patients in a general ICU setting. Methods: This protocol summarizes the rationale and design of a randomized, controlled, single-center trial investigating the effect of mandatory insulin therapy versus usual care insulin therapy for those patients admitted for a stay of longer than 48 hours. In total, 109 critically ill adults predicted to stay in intensive care for longer than 48 hours consented. The primary outcome is to determine the safety of mandatory insulin therapy in critically ill patients using the number of episodes of hypoglycaemia and hypokalaemia per unit length of stay in intensive care. Secondary outcomes include the duration of mechanical ventilation, duration of ICU and hospital stay, hospital mortality, and measures of renal, hepatic, and haematological dysfunction. Results: The project was funded in 2005 and enrolment was completed 2007. Data analysis is currently underway and the first results are expected to be submitted for publication in 2018. Conclusions: This protocol for a randomized controlled trial investigating the effect of mandatory insulin therapy should provide an answer to a key question for the management of patients in the ICU and ultimately improving outcome. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN00550641; (Archived at WebCite:

  • Growing up children in two worlds. Source: Created by authors; Copyright: The authors; URL:; License: Public Domain (CC0).

    Building Yolŋu Skills, Knowledge, and Priorities into Early Childhood Assessment and Support: Protocol for a Qualitative Study


    Background: Yolngu or Yolŋu are a group of indigenous Australian people inhabiting north-eastern Arnhem Land in the Northern Territory of Australia. Recent government policy addressing disparities in outcomes between Indigenous and other children in Australia has resulted in the rapid introduction of early childhood interventions in remote Aboriginal communities. This is despite minimal research into their appropriateness or effectiveness for these contexts. Objective: This research aims to privilege Aboriginal early childhood knowledge, priorities and practices and to strengthen the evidence base for culturally responsive and relevant assessment processes and support that distinguishes “difference” from “deficit” to facilitate optimal child development. Methods: This collaborative qualitative research employs video ethnography, participant observation and in-depth interviews, involving Aboriginal families and researchers in design, implementation, interpretation and dissemination using a locally developed, culturally responsive research approach. Longitudinal case studies are being conducted with 6 families over 5 years and emerging findings are being explored with a further 50 families and key community informants. Data from all sources are analyzed inductively using a collaborative and iterative process. The study findings, grounded in an in-depth understanding of the cultural context of the study but with relevance to policy and practice more widely, are informing the development of a Web-based educational resource and targeted knowledge exchange activities. Results: This paper focuses only on the research approach used in this project. The findings will be reported in detail in future publications. In response to community concerns about lack of recognition of Aboriginal early childhood strengths, priorities and knowledge, this collaborative community-driven project strengthens the evidence base for developing culturally responsive and relevant early childhood services and assessment processes to support optimal child development. The study findings are guiding the development of a Web-based educational resource for staff working with Aboriginal communities and families in the field of early child development. This website will also function as a community-developed tool for strengthening and maintaining Aboriginal knowledge and practice related to child development and child rearing. It will be widely accessible to community members through a range of platforms (eg, mobile phones and tablets) and will provide a model for other cultural contexts. Conclusions: This project will facilitate wider recognition and reflection of cultural knowledge and practice in early childhood programs and policies and will support strengthening and maintenance of cultural knowledge. The culturally responsive and highly collaborative approach to community-based research on which this project is based will also inform future research through sharing knowledge about the research process as well as research findings.

  • Mobile app for supportive care during radiotherapy (montage). Source: The Authors /; Copyright: JMIR Publications; URL:; License: Creative Commons Attribution (CC-BY).

    Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial


    Background: The increasing role of consumer electronics and Web-enabled mobile devices in the medical sector opens up promising possibilities for integrating novel technical solutions into therapy and patient support for oncologic illnesses. A recent survey carried out at Heidelberg University Hospital suggested a high acceptance among patients for an additional approach to patient care during radiotherapy based on patient-reported outcomes by a dedicated mobile app. Objective: The aim of this trial (OPTIMISE-1: Oncologic Therapy Support Via Means of a Dedicated Mobile App – A Prospective Feasibility Evaluation) is to prospectively evaluate the feasibility of employing a mobile app for the systematic support of radiooncological patients throughout the course of their radiotherapy by monitoring symptoms and patient performance, and facilitating the background-exchange of relevant information between patient and physician. Methods: The present single-center, prospective, exploratory trial, conducted at Heidelberg University Hospital, assesses the feasibility of integrating an app-based approach into patient-care during radiotherapy. Patients undergoing curative radiotherapy for thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related quality of life (QoL) and symptoms, and their need to personally consult a physician by means of a mobile app during treatment. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and health-related QoL is assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires at the beginning (baseline) and end of radiotherapy, and at the first follow-up. Results: This trial will recruit 50 patients over a period of 12 months. Follow-up will be completed after 18 months, and publication of results is planned at 24 months after trial initiation. Conclusions: This study will serve as a basis for future studies aiming to exploit the constant innovation in mobile medical appliances and integrate novel patient-centered concepts into patient care in the context of radiotherapy. Trial Registration: NCT03168048; (Archived at WebCite

  • Source: Pixabay; Copyright: Steve Buissinne; URL:; License: Public Domain (CC0).

    Treatment with Creatine Monohydrate in Spinal and Bulbar Muscular Atrophy: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial


    Background: Although spinal and bulbar muscular atrophy (SBMA) has been classified as a motor neuron disease, several reports have indicated the primary involvement of skeletal muscle in the pathogenesis of this devastating disease. Recent studies reported decreased intramuscular creatine levels in skeletal muscles in both patients with SBMA and transgenic mouse models of SBMA, which appears to contribute to muscle weakness. Objective: The present study aimed to examine the efficacy and safety of oral creatine supplementation to improve motor function in patients with SBMA. Methods: A randomized, double-blind, placebo-controlled, three-armed clinical trial was conducted to assess the safety and efficacy of creatine therapy in patients with SBMA. Patients with SBMA eligible for this study were assigned randomly in a 1:1:1 ratio to each group of placebo, 10 g, or 15 g daily dose of creatine monohydrate in a double-blind fashion. Participants took creatine or placebo orally 3 times a day for 8 weeks. Outcome measurements were results of neurological assessments, examinations, and questionnaires collected at baseline and at weeks 4, 8, and 16 after a washout period. The primary endpoint was the change in handgrip strength values from baseline to week 8. The secondary endpoints included the following: results of maximum voluntary isometric contraction tests of extremities; tongue pressure; results of the 15-foot timed walk test and the rise from bed test; modified quantitative myasthenia gravis score; respiratory function test results; activities of daily living assessed with the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale and the Spinal and Bulbar Muscular Atrophy Functional Rating Scale; skeletal muscle mass measured with dual-energy X-ray absorptiometry; urinary 8-hydroxydeoxyguanosine levels; and questionnaires examining the quality of life, swallowing function, and fatigue. Results: Participant enrollment in the trial started from June 2014 and follow-up was completed in July 2015. The study is currently being analyzed. Conclusions: This is the first clinical trial evaluating creatine therapy in SBMA. Given that creatine serves as an energy source in skeletal muscles, recovery of intramuscular creatine concentration is expected to improve muscle strength. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000012503; (Archived by WebCite at

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  • Evaluating use of smart home technology by people with brain impairment: A Single Case Experimental Design Protocol

    Date Submitted: Mar 19, 2018

    Open Peer Review Period: Mar 21, 2018 - Apr 4, 2018

    Smart home technologies, integrated into housing for people with brain impairment, are emerging as a useful component of support delivery to this group. To promote successful uptake and sustained use...

    Smart home technologies, integrated into housing for people with brain impairment, are emerging as a useful component of support delivery to this group. To promote successful uptake and sustained use of such technologies, recent research recommends that renewed focus be placed on technology support services, including training. This paper presents a systematic training approach for use with people with brain impairment, and outlines a multiple baseline, single-case experimental design methodology that will be used to evaluate its effectiveness. Participants will be recruited from new models of support housing with integrated smart home technology. The future evaluation of this training approach will offer new insights into the technology-related training needs of people with brain impairment, and assist therapists in planning for the technology support services that will need to accompany provision of new devices or systems to clients.

  • Types and Frequency of Infusion Pump Alarms: A Retrospective Data Analysis Study Protocol

    Date Submitted: Mar 19, 2018

    Open Peer Review Period: Mar 19, 2018 - Apr 2, 2018

    The variety of alarms from all types of medical devices has increased from six to 40 in the last three decades, with today’s most critically ill patients experiencing as many as 45 alarms per hour....

    The variety of alarms from all types of medical devices has increased from six to 40 in the last three decades, with today’s most critically ill patients experiencing as many as 45 alarms per hour. The high proportion of non-actionable alarms emanating from medical devices has been associated with increased clinical staff desensitization to all types of alarms. Alarm fatigue has been identified as a critical safety issue that can lead to potentially dangerous delays or non-response to actionable alarms resulting in serious patient injury and death. To date, most research on medical device alarms has focused on the non actionable alarms of physiological monitoring devices, with few published reports related to the types and frequencies of actionable infusion pump alarms. The objectives of this study protocol are to establish baseline data related to the types and frequency of infusion pump alarms associated with approximately 550,000 infusions over a 60 day period at 32 US hospitals. In addition, infusion pump alarm types and frequencies will be analyzed to assess consistencies and inconsistencies between hospitals and hospital units, and establish what factors may contribute to these differences. Understanding the incidences and characteristics of infusion pump alarms will result in more informed quality improvement recommendations to decrease and/or modify infusion pump alarms and potentially reduce clinical staff alarm fatigue and improve patient safety.

  • Health Disparities in Jail Populations Protocol

    Date Submitted: Mar 19, 2018

    Open Peer Review Period: Mar 19, 2018 - Apr 2, 2018

    Background: Incarcerated populations have increased in the last 20 years and over 12 million individuals cycle in and out of jails each year. Previous research has predominately focused on the prison...

    Background: Incarcerated populations have increased in the last 20 years and over 12 million individuals cycle in and out of jails each year. Previous research has predominately focused on the prison population. However, a substantial gap exists in understanding the health, wellbeing, and health care utilization patterns in jail populations. Objective: The Health Disparities in Jail Populations pilot study has five main objectives: (1) define “super users” of the jail system, individuals characterized by high incarceration rates; (2) describe and compare characteristics of incarcerated individuals; (3) identify jail associated health disparities; (4) estimate associations between incarceration and health; and (5) model patterns in healthcare and jail utilization. Methods: The project is functionally separated into two processes: a comprehensive secondary data analysis and primary data collection that includes a cross-sectional health survey and collection of biological samples. The secondary data analysis includes the analysis of eight distinct databases: (1) the Superior Court of Arizona, (2) North Country Health Care; (3) Health Choice Integrated Care (behavioral health); (4) Criminal Justice Information Services; (5) Correctional Electronic Medical Records; (6) iLEADS (the jail’s inmate records system); (7) Arizona Department of Health Services; and (8) Coconino County Health Department. We will perform data integration employing an honest broker design to provide a longitudinal view of an individual across multiple community-based health providers, criminal justice databases, and jail-based health services. We will also administer a cross-sectional health survey among 200 Coconino County Detention Facility inmates. The survey includes in-depth questions about health status indicators, health history, health care system utilization, substance use practices, behavioral health, and psychiatric diagnoses. Concurrent with the survey administration we will collect MRSA/MSSA (S. aureus samples from the nose) and dental microbiome (S. sobrinus and S. mutans samples from the mouth) from consenting participants. Results: To date, we have permission to link data across acquired databases. We also have access to the Coconino County Detention Facility inmates. To date, of the 58 inmates interviewed, we have permission from 97% to access and link electronic medical and incarceration records to their survey responses and 95% of interviewed inmates have given nasal and buccal swabs for analysis of S. aureus and the dental microbiome. Conclusions: The Health Disparities in Jail Populations study is designed to increase the understanding of health needs and healthcare utilization patterns among jail populations. Our findings will allow for identification of points of intervention throughout the criminal justice and health care systems to improve health and reduce health disparities among jail inmates.

  • Patient Preferences and Willingness to Pay for Cervical Cancer Prevention in Zambia: Protocol for a Multi-Cohort Discrete Choice Experiment

    Date Submitted: Mar 16, 2018

    Open Peer Review Period: Mar 18, 2018 - Apr 1, 2018

    Background Most of the global burden of cervical cancer is experienced in countries with limited resources, and mortality from cervical cancer is the most common cause of cancer-related deaths among...

    Background Most of the global burden of cervical cancer is experienced in countries with limited resources, and mortality from cervical cancer is the most common cause of cancer-related deaths among women in Sub-Saharan Africa. The purpose of this study is to learn about preferences for cervical cancer screening in Zambia, to identify barriers and facilitators for screening uptake, and to evaluate willingness to pay for screening services. Methods/Design We will conduct a discrete choice experiment by interviewing women and men and asking them to choose among constructed scenarios with varying combinations of attributes relevant to cervical cancer screening. To inform the discrete choice experiment, we will conduct focus groups and interviews about general knowledge and attitudes about cervical screening, perception about the availability of screening, stigma associated with cancer and HIV, and payment for health care services. For the discrete choice experiment, we will have a maximum design of 120 choice sets divided into 15 sets of 8 tasks each with a sample size of 320 to 400 respondents. We will use a hierarchical Bayesian estimation procedure to assess attributes at two levels: group and individual levels. The model will generate preferences for attributes to assess the most important features and allow for assessment of differences among cohorts. We will conduct policy simulations reflecting potential changes in the attributes of the screening facilities and calculate the projected changes in preference for selecting to undergo cervical cancer screening. The findings from the discrete choice experiment will be supplemented with interviews, focus groups, and patient surveys to ensure a comprehensive and context-based interpretation of the results. Discussion Because willingness to pay for cervical cancer screening has not been previously assessed, this will be a unique and important contribution to the literature. This study will take into account the high HIV prevalence in Sub-Saharan Africa and prevailing gender attitudes to identify an optimal package of interventions to reduce cervical cancer incidence. This simulation of women’s decisions (and men’s support) to undergo screening will lay the foundation for understanding stated preferences and willingness to pay to help design future screening programs.

  • Effectiveness of Web-based Cognitive Bias Intervention for Psychiatric Disorders: A Systematic Review Protocol

    Date Submitted: Mar 15, 2018

    Open Peer Review Period: Mar 16, 2018 - Mar 30, 2018

    Background: Traditional psychological therapies focus mainly on modification of individuals’ conscious decision-making process. Unconscious processes such as cognitive biases have been found to be...

    Background: Traditional psychological therapies focus mainly on modification of individuals’ conscious decision-making process. Unconscious processes such as cognitive biases have been found to be accountable for various psychiatric psychopathologies. The advances in technologies have transformed how bias modification programs are being delivered. Objective: We seek to synthesize the current evidence of web-based cognitive bias modification for psychiatric disorders, by identifying the range of conditions targeted and their current efficacy. We wish to determine if web-based attention bias modification is as efficacious as compared to conventional methods. Methods and analysis: A systematic review will be conducted, and all studies types will be included. There will not be any restrictions on the participants included in the study. A search will be conducted on the respective databases up till 2017. Selection of studies will be by the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA-P) guidelines. Quality assessment of the included studies will be assessed using the Cochrane Risk of Bias tool (for randomized trials) and the Newcastle-Ottawa scale for other study designs. A narrative synthesises of the identified articles will be conducted. A meta-analysis will be considered, only if there are sufficient articles in a domain for statistical analysis. Ethical approval for the current protocol and the planned systematic review was not required. Results: Results synthesized would be disseminated using conference presentation or published works in peer-reviewed journals. Conclusions: This review is of importance given how technology transformed the delivery of conventional therapies. The findings from this review will provide guidance for future research involving technology and cognitive bias modification interventions. Registration details: International Prospective Register for Systematic Reviews (PROSPERO) number 2017 CRD42017074754

  • e-Prehabilitation System of Care for Teenagers and Young Adults diagnosed with Cancer: Study Protocol

    Date Submitted: Mar 3, 2018

    Open Peer Review Period: Mar 16, 2018 - Mar 30, 2018

    Background: A diagnosis of cancer in young adulthood can pose many different and unique challenges for individuals. Provision of adequate and appropriate information, care and support for teenagers an...

    Background: A diagnosis of cancer in young adulthood can pose many different and unique challenges for individuals. Provision of adequate and appropriate information, care and support for teenagers and young adults around the time of diagnosis is central to their healthcare experience going forward. Appropriate and accessible information provision is critical to ensure young people with cancer feel equipped and empowered to make decisions about, and be involved in, their treatment and recovery throughout their experience; a concept known as prehabilitation. As digital interventions and resources to support TYA with cancer are an increasingly desirable part of healthcare provision, this study will focus on the development of an age and population appropriate (e)lectronic-prehabilitation system of care. Objective: An exploratory, co-design research project will inform the development of an e-Prehabilitation system of care to support Teenagers and Young Adults diagnosed with cancer. A collaborative approach to data collection and prototype design will ensure a patient-centred approach is embedded throughout. Methods: Qualitative, co-design utilising surveys, interviews and focus groups with Teenagers and Young Adults and Health Care Professionals. Results: This research study is in progress; data collection activities have commenced and findings are expected in Summer 2018. Conclusions: The findings from this study will have important implications for informing the future development and evaluation of an e-Prehabilitation system of care to support TYA diagnosed with cancer. Clinical Trial: N/A