JMIR Publications

JMIR Research Protocols

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

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) publishes 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 new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2015: 4.532)

JMIR Res Protoc 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 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)

 
 

Recent Articles:

  • Medical professional. Source: Alachua County; Copyright: via flickr; URL: https://www.flickr.com/photos/alachuacounty/23982227052/in/photostream/; License: Creative Commons Attribution (CC-BY).: licensed under creative commons attribution 2.0

    Use of the Total Cancer Care System to Enrich Screening for CD30-Positive Solid Tumors for Patient Enrollment Into a Brentuximab Vedotin Clinical Trial: A...

    Abstract:

    Background: One approach to identify patients who meet specific eligibility criteria for target-based clinical trials is to use patient and tumor registries to prescreen patient populations. Objective: Here we demonstrate that the Total Cancer Care (TCC) Protocol, an ongoing, observational study, may provide a solution for rapidly identifying patients with CD30-positive tumors eligible for CD30-targeted therapies such as brentuximab vedotin. Methods: The TCC patient gene expression profiling database was retrospectively screened for CD30 gene expression determined using HuRSTA-2a520709 Affymetrix arrays (GPL15048). Banked tumor tissue samples were used to determine CD30 protein expression by semiquantitative immunohistochemistry. Statistical comparisons of Z- and H-scores were performed using R statistical software (The R Foundation), and the predictive value, accuracy, sensitivity, and specificity of CD30 gene expression versus protein expression was estimated. Results: As of March 2015, 120,887 patients have consented to the institutional review board–approved TCC Protocol. A total of 39,157 fresh frozen tumor specimens have been collected, from which over 14,000 samples have gene expression data available. CD30 RNA was expressed in a number of solid tumors; the highest median CD30 RNA expression was observed in primary tumors from lymph node, soft tissue (many sarcomas), lung, skin, and esophagus (median Z-scores 1.011, 0.399, 0.202, 0.152, and 1.011, respectively). High level CD30 gene expression significantly enriches for CD30-positive protein expression in breast, lung, skin, and ovarian cancer; accuracy ranged from 72% to 79%, sensitivity from 75% to 100%, specificity from 70% to 76%, positive predictive value from 20% to 40%, and negative predictive value from 95% to 100%. Conclusions: The TCC gene expression profiling database guided tissue selection that enriched for CD30 protein expression in a number of solid tumor types. Such an approach may improve screening efficiency for enrolling patients into biomarker-based clinical trials.

  • Happy Patient. Copyright: iStock by Getty Images; URL: http://media.gettyimages.com/photos/loving-father-and-daughter-together-on-sofa-picture-id466144313; License: Licensed by the authors.

    Implementation of a Home Monitoring System for Heart Failure Patients: A Feasibility Study

    Abstract:

    Background: Improving the management of patients with complex chronic disease is a substantial undertaking with the simultaneous goals of improving patient outcomes and controlling costs. Reducing avoidable hospitalization for such patients is a step toward both objectives. Some of the deterioration experienced in chronic disease patients occurs outside the view of their clinicians, and before the patient becomes overtly symptomatic. Home monitoring has been used for more than 20 years to detect deterioration earlier so that the patients could be treated before they became ill enough to require hospitalization. Patient participation is an important requirement for successful home monitoring. There has been some concern that patients would be unwilling or unable to engage in a program that collected multiple measurements. The Cedars-Sinai Cardiology Center provides a high-touch, intense management program for patients with congestive heart failure (CHF). A group of their patients were chosen to join a complex, multidevice home monitoring system to see whether such patients would find value in the additional effort. Objective: The objective of our study was to determine whether patients already actively engaged in a high-touch intensive management program for CHF would take on the additional burden of a complex home monitoring effort. Methods: A total of 20 patients from the Cedars-Sinai group were enrolled in a monitoring program utilizing 5 different devices. Anonymous surveys were collected from the patients to assess their satisfaction with the program. Results: In total, 90% (18/20) completed the program, and 61% (11/20) submitted the survey. Among the 18 patients, overall compliance with the requested measurements was 70%. It was found that 73% (8/11) felt better about their health as a result of the program, whereas another 73% (8/11) believed that the care team now had a better picture of their health. Conclusions: Substantial patient compliance and satisfaction can be achieved in a sophisticated home monitoring program.

  • Police on the day before the 2013 Inauguration. Image source: Copyright Victoria Pickering via Flickr https://flic.kr/p/dYGBiS. Licensed by authors under Creative Commons Attribution 2.0.

    Biometrics and Policing: A Protocol for Multichannel Sensor Data Collection and Exploratory Analysis of Contextualized Psychophysiological Response During...

    Abstract:

    Background: Stress experienced by law enforcement officers is often extreme and is in many ways unique among professions. Although past research on officer stress is informative, it is limited, and most studies measure stress using self-report questionnaires or observational studies that have limited generalizability. We know of no research studies that have attempted to track direct physiological stress responses in high fidelity, especially within an operational police setting. The outcome of this project will have an impact on both practitioners and policing researchers. To do so, we will establish a capacity to obtain complex, multisensor data; process complex datasets; and establish the methods needed to conduct idiopathic clinical trials on behavioral interventions in similar contexts. Objective: The objective of this pilot study is to demonstrate the practicality and utility of wrist-worn biometric sensor-based research in a law enforcement agency. Methods: We will use nonprobability convenience-based sampling to recruit 2-3 participants from the police department in Durham, North Carolina, USA. Results: Data collection was conducted in 2016. We will analyze data in early 2017 and disseminate our results via peer reviewed publications in late 2017. Conclusions: We developed the Biometrics & Policing Demonstration project to provide a proof of concept on collecting biometric data in a law enforcement setting. This effort will enable us to (1) address the regulatory approvals needed to collect data, including human participant considerations, (2) demonstrate the ability to use biometric tracking technology in a policing setting, (3) link biometric data to law enforcement data, and (4) explore project results for law enforcement policy and training.

  • Person typing on computer. Image source: https://pixabay.com/en/hands-laptop-computer-typing-2069206. Copyright: CCO Public Domain.

    Writing for Health: Rationale and Protocol for a Randomized Controlled Trial of Internet-Based Benefit-Finding Writing for Adults With Type 1 or Type 2 Diabetes

    Abstract:

    Background: Diabetes mellitus is Australia’s fastest growing chronic disease, and has high comorbidity with depression. Both subthreshold depression and diabetes distress are common amongst people with type 1 or type 2 diabetes, and are associated with poorer diabetes self-care. A need exists for low-intensity self-help interventions for large numbers of people with diabetes and diabetes distress or subthreshold depression, as part of a stepped-care approach to meeting the psychological needs of people with diabetes. Benefit-finding writing is a very brief intervention that involves writing about any positive thoughts and feelings about a stressful experience, such as an illness. Benefit-finding writing has been associated with increases in positive affect and positive growth, and has demonstrated promising results in trials amongst other clinical populations. However, benefit-finding writing has not yet been examined in people with diabetes. Objective: The aim of this randomized controlled trial (RCT) is to evaluate the efficacy of an Internet-based benefit-finding writing (iBFW) intervention for adults with type 1 or type 2 diabetes (compared to a control writing condition) for reducing diabetes distress and increasing benefit-finding in diabetes, and also improving a range of secondary outcomes. Methods: A two-arm RCT will be conducted, using the online program Writing for Health. Adults with type 1 or type 2 diabetes living in Australia will be recruited using diabetes-related publications and websites, and through advertisements in diabetes services and general practitioners’ offices. Potential participants will be referred to the study-specific website for participant information and screening. All data will be collected online. Participants will be randomized to either iBFW about diabetes, or a control writing condition of writing about use-of-time. Both conditions involve three daily sessions (once per day for three consecutive days) of 15-minute online writing exercises. Outcome measures will be administered online at baseline, one-month, and three-month follow-ups. Results: This trial is currently underway. The primary outcomes will be diabetes distress and benefit-finding in diabetes. Secondary outcomes will be depression, anxiety, diabetes self-care, perceived health, and health care utilization. We aim to recruit 104 participants. All stages of the study will be conducted online using the Writing for Health program. Group differences will be analyzed on an intention-to-treat basis using mixed models repeated measures. Linguistic analyses of the writing exercise scripts, and examinations of the immediate emotional responses to the writing exercises, will also be undertaken. Conclusions: This RCT will be the first study to examine iBFW for adults with type 1 or type 2 diabetes. If iBFW is found to be efficacious in reducing diabetes distress and improving diabetes self-care and other outcomes, iBFW may offer the potential to be a low-cost, easily accessible self-help intervention to improve the wellbeing of adults with diabetes. Trial Registration: Australia and New Zealand Clinical Trials Registry (ACTRN12615000241538)

  • Image source: Created by the authors via Unsplash http://bit.ly/2nkinQk. Licensed under Creative Commons Zero.

    Home-Based Intervention Program to Reduce Food Insecurity in Elderly Populations Using a TV App: Study Protocol of the Randomized Controlled Trial...

    Abstract:

    Background: The limited or uncertain access to adequate food in elderly people includes not only economic restrictions but also inability of food utilization due to functional or cognitive impairment, health problems, and illiteracy. Objective: The aim of this work is to present the protocol of the randomized controlled trial Saúde.Come Senior, an educational and motivational television (TV)-based intervention to promote healthy lifestyles and decrease food insecurity in elderly people. Methods: A randomized controlled study will be conducted in subjects aged 60 years and older with food insecurity, identified at 17 primary care centers in the Lisboa e Vale do Tejo health region in Lisbon, Portugal. The primary outcome will be the changes in participants’ food insecurity score (evaluated by the Household Food Insecurity Scale) at 3 months. Change in other outcomes will be assessed (dietary habits, nutritional status, physical activity, health status, and clinical outcomes). Subjects will be followed over 6 months; the intervention will last 3 months. Data collection will be performed at 3 different time points (baseline, end of intervention at 3 months, and follow-up at 6 months). The intervention is based on an interactive TV app with an educational and motivational program specifically developed for the elderly that has weekly themes and includes daily content in video format: (1) nutrition and diet tips for healthy eating, (2) healthy, easy to cook and low-cost recipes, and (3) physical exercise programs. Furthermore, brief reminders on health behaviors will also be broadcasted through the TV app. The total duration of the study will be 6 months. The intervention is considered to be effective and meaningful if 50% of the individuals in the experimental group have a decrease of 1 point in the food insecurity score, all the remaining being unchanged. We expect to include and randomize 282 (141 experimental and 141 control) elderly with food insecurity. We will recruit a total of 1,128 subjects considering that 50% of the target individuals are food insecure (based on INFOFAMÍLIA Survey) (567) and about 50% of those will adhere to the study (282). Results: The randomized controlled trial with the 12-week home-based intervention with a comprehensive program on healthy eating and physical activity delivery is planned to start recruiting participants at the end of 2017. Conclusions: This study will assess the efficacy of this innovative tool (Saúde.Come Senior) for disseminating relevant health information, modifying behaviors, and decreasing food insecurity in an easy, low-cost, and massive way.

  • MP3 Youth study logo. Image created by the authors. Licensed under Creative Commons Attribution 2.0.

    Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol

    Abstract:

    Background: Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. Objective: The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. Methods: The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. Results: The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. Conclusions: The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. Trial Registration: ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54)

  • Image Source: https://static.pexels.com/photos/161641/pills-medicine-tablets-depending-161641.jpeg 
licensed under Creative Commons 2.0.

    Patterns and Predictors of Adherence to Statin Therapy Among Older Patients: Protocol for a Systematic Review

    Abstract:

    Background: The benefits of statin therapy are significantly compromised by noncompliance. Although elderly patients may have particular challenges with medication adherence and persistence, previous reviews on statin adherence have not focused on this population. Additionally, comparisons of adherence and persistence specific to statin indication (primary or secondary prevention) have not been thoroughly explored. Objective: We aim to assess the extent of, and factors associated with, adherence and persistence to statin therapy among older populations (aged ≥65 years). Methods: A systematic review will be undertaken according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses recommendations. Searches will be performed using multiple electronic databases (Ovid MEDLINE, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and the National Health Service Economic Evaluation Database) to identify relevant randomized trials and observational studies that evaluated statin adherence and/or persistence as an outcome. Eligible studies will include those involving community-living or outpatient elderly individuals. The methodological quality of randomized controlled trials (RCTs) will be assessed via the Joanna Briggs Institute’s critical appraisal checklist for RCTs, and the quality assessment of observational studies will be undertaken using a set of questions formulated with resort to the National Institute of Health Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. When possible, meta-analyses will be conducted using random-effect modeling and generic inverse variance analyses for adjusted-effect estimates. Heterogeneity across studies will be quantified using the I2 statistic. The presence of publication bias will be assessed using funnel plots and Egger’s regression tests. A leave-one-out sensitivity analysis will also be conducted to assess the impact of individual study results on pooled estimates. To explore possible sources of heterogeneity across studies, subgroup analyses will be performed based on covariates such as study design, statin indication, country of study, and length of patient follow-up. Results: The electronic database searches were completed in December 2016. Retrieved articles are currently being screened and the entire study is expected to be completed by June 2017. Conclusions: This systematic review will provide further understanding of the patterns of, and barriers to, statin adherence and persistence among older patients. The findings will inform clinical practice and the design of appropriate interventions. Trial Registration: PROSPERO CRD42016053191

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    Enhancing mHealth Technology in the Patient-Centered Medical Home Environment to Activate Patients With Type 2 Diabetes: A Multisite Feasibility Study Protocol

    Abstract:

    Background: The potential of mHealth technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts to date have incorporated a variety of tools and techniques, including Web-based portals, short message service (SMS) text messaging, remote collection of biometric data, electronic coaching, electronic-based health education, secure email communication between visits, and electronic collection of lifestyle and quality-of-life surveys. Each of these tools, used alone or in combination, have demonstrated varying degrees of effectiveness. Some of the more promising results have been demonstrated using regular collection of biometric devices, SMS text messaging, secure email communication with clinical teams, and regular reporting of quality-of-life variables. In this study, we seek to incorporate several of the most promising mHealth capabilities in a patient-centered medical home (PCMH) workflow. Objective: We aim to address underlying technology needs and gaps related to the use of mHealth technology and the activation of patients living with type 2 diabetes. Stated differently, we enable supporting technologies while seeking to influence patient activation and self-care activities. Methods: This is a multisite phased study, conducted within the US Military Health System, that includes a user-centered design phase and a PCMH-based feasibility trial. In phase 1, we will assess both patient and provider preferences regarding the enhancement of the enabling technology capabilities for type 2 diabetes chronic care management. Phase 2 research will be a single-blinded 12-month feasibility study that incorporates randomization principles. Phase 2 research will seek to improve patient activation and self-care activities through the use of the Mobile Health Care Environment with tailored behavioral messaging. The primary outcome measure is the Patient Activation Measure scores. Secondary outcome measures are Summary of Diabetes Self-care Activities Measure scores, clinical measures, comorbid conditions, health services resource consumption, and technology system usage statistics. Results: We have completed phase 1 data collection. Formal analysis of phase 1 data has not been completed. We have obtained institutional review board approval and began phase 1 research in late fall 2016. Conclusions: The study hypotheses suggest that patients can, and will, improve their activation in chronic care management. Improved activation should translate into improved diabetes self-care. Expected benefits of this research to the scientific community and health care services include improved understanding of how to leverage mHealth technology to activate patients living with type 2 diabetes in self-management behaviors. The research will shed light on implementation strategies in integrating mHealth into the clinical workflow of the PCMH setting. Clinical Trial: ClinicalTrials.gov NCT02949037. https://clinicaltrials.gov/ct2/show/NCT02949037. (Archived by WebCite at http://www.webcitation.org/6oRyDzqei)

  • Image Source: Penn State, via FlickR https://drks-neu.uniklinik-freiburg.de/drks_web/PdfDownstreamServlet?ID=DRKS00010538&LOCALE=en. Licensed under cc-by-nc 2.0.

    Effectiveness of a 16-Week Multimodal Exercise Program on Individuals With Dementia: Study Protocol for a Multicenter Randomized Controlled Trial

    Abstract:

    Background: The increasing prevalence of dementia in the next decades is accompanied by various societal and economic problems. Previous studies have suggested that physical activity positively affects motor and cognitive skills in individuals with dementia (IWD). However, there is insufficient evidence probably related to several methodological limitations. Moreover, to date adequate physical activity interventions specifically developed for IWD are lacking. Objective: This study aims to investigate the effectiveness of a multimodal exercise program (MEP) on motor and cognitive skills in IWD in a high-quality multicenter trial. Methods: A multicenter randomized controlled trial with baseline and postassessments will be performed. It is planned to enroll 405 participants with dementia of mild to moderate stage, aged 65 years and older. The intervention group will participate in a 16-week ritualized MEP especially developed for IWD. The effectiveness of the MEP on the primary outcomes balance, mobility, and gait will be examined using a comprehensive test battery. Secondary outcomes are strength and function of lower limbs, activities of daily living, and cognition (overall cognition, language, processing speed, learning and memory, and visual spatial cognition). Results: Enrollment for the study started in May 2015. It is planned to complete postassessments by the beginning of 2017. Results are expected to be available in the first half of 2017. Conclusions: This study will contribute to enhancing evidence for the effects of physical activity on motor and cognitive skills in IWD. Compared to previous studies, this study is characterized by a dementia-specific intervention based on scientific knowledge, a combination of motor and cognitive tasks in the intervention, and high standards regarding methodology. Findings are highly relevant to influence the multiple motor and cognitive impairments of IWD who are often participating in limited physical activity. Trial Registration: German Clinical Trials Register DRKS00010538; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010538 (Archived by WebCite at http://www.webcitation.org/6oVGMbbMD)

  • Image Source: The authors.

    Workability and Muscle Strength in Patients With Seropositive Rheumatoid Arthritis: Survey Study Protocol

    Abstract:

    Background: Rheumatoid arthritis (RA) and other rheumatic conditions not only fundamentally affect patients’ quality of life and physiological needs but are also negatively associated with work ability. The costs of poor work ability, which, in sum, are more than treatment costs, pose an economic burden to society and patients. Work ability in RA appears to be multifactorial; symptoms such as pain, swelling, and stiffness play a major role, as these directly affect functional disability. Also, RA patients typically suffer from reduced muscle strength. Lower extremity function and grip strengths especially impair their quality of life. However, the role of muscle strength and disease activity as determinants of work ability have not yet been studied. Objective: The primary objective of this study is to compare work ability in working-age participants with seropositive RA and with high and low disease activity; the secondary objective is to evaluate the association of muscle strength, functional ability, and frailty with work ability. Methods: This monocentric cross-sectional study will be conducted at a rheumatologic outpatient clinic and day hospital with approximately 100 seropositive RA patients aged <65 years. A clinical disease activity index as a measure for rheumatoid disease activity will be assessed during the patients’ routine visits at the clinic. Work ability, frailty, and functional disability will be evaluated with (self-reported) questionnaires as well as with physical tests (Work Ability Index/Score; Health Assessment Questionnaire Disability Index; Survey of Health, Ageing, and Retirement in Europe Frailty Instrument; Short Physical Performance Battery). Muscle strength will be determined with dynamometer measurements of isometric hand grip strength and quadriceps femoris muscle contraction strength. Sleep quality (Medical Outcomes Study Sleep Scale) and sexual functioning as physiological needs will additionally be determined with self-reported questionnaires. Results: For this study funding has already been awarded and enrollment has been completed. Data are currently being evaluated. Conclusions: This study will evaluate the association of work ability with modifiable parameters such as muscle strength and functional ability. It will provide further insights into work ability in RA and its associated risk factors. Any evidence of association will motivate further research, and the findings might encourage interventions focused specifically on improving muscle strength and lower extremity function to positively affect work ability. Clinical Trial: ClinicalTrials.gov (NCT02581852); https://clinicaltrials.gov/ct2/show/NCT02581852 (Archived by WebCite at http://www.webcitation.org/6oNcelHtQ)

  • TEMPOJIMS main facilities. Source: Figure 4 from https://www.researchprotocols.org/2017/3/e37; Copyright: the authors; License: Creative Commons Attribution (CC-BY).

    Bioengineered Temporomandibular Joint Disk Implants: Study Protocol for a Two-Phase Exploratory Randomized Preclinical Pilot Trial in 18 Black Merino Sheep...

    Abstract:

    Background: Preclinical trials are essential to test efficacious options to substitute the temporomandibular joint (TMJ) disk. The contemporary absence of an ideal treatment for patients with severe TMJ disorders can be related to difficulties concerning the appropriate study design to conduct preclinical trials in the TMJ field. These difficulties can be associated with the use of heterogeneous animal models, the use of the contralateral TMJ as control, the absence of rigorous randomized controlled preclinical trials with blinded outcomes assessors, and difficulties involving multidisciplinary teams. Objective: This study aims to develop a new, reproducible, and effective study design for preclinical research in the TMJ domain, obtaining rigorous data related to (1) identify the impact of bilateral discectomy in black Merino sheep, (2) identify the impact of bilateral discopexy in black Merino sheep, and (3) identify the impact of three different bioengineering TMJ discs in black Merino sheep. Methods: A two-phase exploratory randomized controlled preclinical trial with blinded outcomes is proposed. In the first phase, nine sheep are randomized into three different surgical bilateral procedures: bilateral discectomy, bilateral discopexy, and sham surgery. In the second phase, nine sheep are randomized to bilaterally test three different TMJ bioengineering disk implants. The primary outcome is the histological gradation of TMJ. Secondary outcomes are imaging changes, absolute masticatory time, ruminant time per cycle, ruminant kinetics, ruminant area, and sheep weight. Results: Previous preclinical studies in this field have used the contralateral unoperated side as a control, different animal models ranging from mice to a canine model, with nonrandomized, nonblinded and uncontrolled study designs and limited outcomes measures. The main goal of this exploratory preclinical protocol is to set a new standard for future preclinical trials in oromaxillofacial surgery, particularly in the TMJ field, by proposing a rigorous design in black Merino sheep. The authors also intend to test the feasibility of pilot outcomes. The authors expect to increase the quality of further studies in this field and to progress in future treatment options for patients undergoing surgery for TMJ disk replacement. Conclusions: The study has commenced, but it is too early to provide results or conclusions.

  • Telerehabilitation session using eHAB app. Image created by author.

    Telerehabilitation Versus Traditional Care Following Total Hip Replacement: A Randomized Controlled Trial Protocol

    Abstract:

    Background: Total hip replacement (THR) is the gold standard treatment for severe hip osteoarthritis. Effectiveness of physical rehabilitation for THR patients following discharge from hospital is supported by evidence; however, barriers such as geographical location and transport can limit access to appropriate health care. One solution to this issue is using an alternative model of care using telerehabilitation technology to deliver rehabilitation programs directly into patients’ homes. A telerehabilitation model may also have potential health care cost savings for health care providers. Objective: This study aims to determine if a telerehabilitation model of care delivered remotely is as effective as face-to-face rehabilitation in the THR population and cost effective for health care providers and patients. Methods: A total of 70 people undergoing THR will be recruited to participate in a randomized, single-blind, controlled noninferiority clinical trial. The trial will compare a technology-based THR rehabilitation program to in-person care. On discharge from hospital, participants randomized to the in-person group will receive usual care, defined as a paper home exercise program (HEP) targeting strengthening exercises for quadriceps, hip abductors, extensors, and flexors; they will be advised to perform their HEP 3 times per day. At 2, 4, and 6 weeks postoperatively, they will receive a 30-minute in-person physiotherapy session with a focus on gait retraining and reviewing and progressing their HEP. The telerehabilitation protocol will involve a program similar in content to the in-person rehabilitation program, except delivery will be directly into the homes of the participants via telerehabilitation technology on an iPad. Outcomes will be evaluated preoperatively, day of discharge from in-patient physiotherapy, 6 weeks and 6 months postoperatively. The primary outcome will be the quality of life subscale of the hip disability and osteoarthritis outcome score, measured at 6 weeks. Both intention-to-treat and per-protocol analyses as recommended in the extension of the Consolidated Standards for Reporting Trials (CONSORT) guideline for noninferiority trials will be performed. Results: Recruitment commenced in September 2015 and is expected to be completed by June 2017. Data collection will be completed by December 2017. It is anticipated the results from this trial will be published by July 2018. Conclusions: Previous research investigating telerehabilitation in postoperative orthopedic conditions has yielded promising results. If shown to be as effective as in-person care, telerehabilitation after THR could be helpful in addressing access issues in this population. Furthermore, it may help reduce the cost of health care provision by enabling patients to take a more independent approach to their rehabilitation. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12615000824561; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364010 (Archived by WebCite at http://www.webcitation.org/6oWXweVfI)

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  • Beliefs, knowledge, implementation and integration of evidence-based practice among primary healthcare providers: protocol for a scoping review

    Date Submitted: Mar 21, 2017

    Open Peer Review Period: Mar 22, 2017 - Apr 5, 2017

    Background: The adoption of evidence-based practice (EBP) is promoted because it is widely recognised for improving the quality and safety of healthcare for patients as well reducing avoidable costs....

    Background: The adoption of evidence-based practice (EBP) is promoted because it is widely recognised for improving the quality and safety of healthcare for patients as well reducing avoidable costs. Providers of primary care face numerous challenges to ensuring effectiveness in their daily practice. Primary healthcare is defined as the entry level into a healthcare services system, providing a first point of contact for all new needs and problems, patient-focused (not disease-oriented) care over time, care for all but the most uncommon or unusual conditions, and coordination or integration of care, regardless of where or by whom that care is delivered. It is the primary means by which to approach the main goal of any healthcare services system: optimisation of health status. Objective: This review aims to scope publications examining beliefs, knowledge, implementation and integration of EBP among primary healthcare providers. Methods: We will conduct a systematic scoping review of published articles in the following electronic databases, from their start dates until 31 March 2017: in Medline via Pubmed (from 1946), Embase (from 1947), CINAHL (from 1937), the Cochrane Central Register of Controlled Trials (from 1992), PsycINFO (from 1806), Web of Science (from 1900), JBI database (from 1998), Dare (from 1996), Tripdatabase (from 1997) and relevant professional scientific journals (from their start dates). We will use the predefined search terms of “evidence-based practice” and “primary healthcare” combined with other terms, such as “beliefs”, “knowledge”, “implementation” and “integration”. We will also conduct a hand search of the bibliographies of all the relevant articles and a search for unpublished studies using Google Scholar, Proquest, Mednar and Worldcat. We will consider publications in English, French, Spanish and Portuguese. Results: The electronic database searches will be completed in April 2017. Retrieved articles are currently being screened, and the entire study is expected to be completed by November 2017. Conclusions: This systematic scoping review will provide a further understanding of the beliefs, knowledge, implementation and integration of EBP among primary healthcare providers. The findings will inform clinical practice and help to draw a global picture of the EBP research topics relevant to primary care providers.

  • A smartphone app using psychological approaches for women with chronic pelvic pain (MEMPHIS): study protocol for a randomised feasibility trial

    Date Submitted: Mar 19, 2017

    Open Peer Review Period: Mar 20, 2017 - Apr 3, 2017

    Background: Chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be aff...

    Background: Chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynaecological referrals in the UK. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative. Mindfulness meditation is a potentially valuable SSM tool, and in the era of mobile technology, this can be delivered to the individual user via a smartphone app. Objective: To assess the feasibility of conducting a trial of a mindfulness meditation intervention delivered by a mobile phone app for patients with CPP. Methods: MEMPHIS is a randomised feasibility trial taking place in two UK hospitals. Eligible participants are randomised in a 1:1:1 ratio to one of three treatment arms: (1) the intervention arm, consisting of a guided, spoken mindfulness meditation app; (2) an active control arm, consisting of a progressive muscle relaxation app; and (3) usual care (no app). Participants are followed up for 6 months. Key feasibility outcomes include time taken to recruit all patients for the study, adherence, and estimates to be used in the sample size calculation for a subsequent full-scale trial. On completion of the feasibility trial we will conduct focus groups to explore app usability and reasons for non-compliance. Results: The trial is currently in follow up phase. Conclusions: This feasibility trial will inform the design of a large multi-centred trial to assess the clinical effectiveness of mindfulness meditation delivered via a smartphone app for the treatment of CPP. Clinical Trial: Clinical trials.gov: NCT02721108 Biomed central ISRCTN10925965 DOI 10.1186/ISRCTN10925965

  • Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants

    Date Submitted: Mar 20, 2017

    Open Peer Review Period: Mar 20, 2017 - Mar 28, 2017

    Background: Despite numerous medical advances in the care of at-risk preterm neonates, oral feeding still represents one of the first and most advanced neurological challenges facing this delicate pop...

    Background: Despite numerous medical advances in the care of at-risk preterm neonates, oral feeding still represents one of the first and most advanced neurological challenges facing this delicate population. Objective, quantitative, and non-invasive assessment tools as well as neurotherapeutic strategies, are greatly needed in order to improve feeding and developmental outcomes. Pulsed pneumatic orocutaneous stimulation has been shown to improve non-nutritive sucking (NNS) skills in preterm infants who exhibit delayed/disordered nipple feeding behaviors. Separately, the study of the salivary transcriptome in neonates has helped identify biomarkers directly linked to successful neonatal oral feeding behavior. The combination of non-invasive treatment strategies and transcriptomic analysis represents an integrative approach to oral feeding where rapid technological advances and personalized transcriptomics can safely and non-invasively be brought to the bedside to inform medical care decisions and improve care and outcomes. Objective: To conduct a multicenter randomized control trial (RCT) to combine molecular and behavioral methods in an experimental conceptualization approach to map the effects of PULSED somatosensory stimulation on salivary gene expression in the context of the acquisition of oral feeding in high-risk human neonates. The aims of this study represent the first attempt to combine non-invasive treatment strategies and transcriptomic assessments of high-risk EPIs to (1) improve oral feeding behavior and skills, (2) further our understanding of the gene ontology of biologically diverse pathways related to oral feeding, (3) use gene expression data to personalize neonatal care and individualize treatment strategies and timing interventions, and (4) improve long-term developmental outcomes. Methods: A total of 180 extremely preterm infants from three neonatal intensive care units (NICUs) will be randomized to receive either PULSED or SHAM (non-pulsing) orocutaneous intervention simultaneous with tube feedings 3 times per day for 4 weeks, beginning at 30 weeks post-conceptional age. Infants will also be assessed 3 times per week for NNS performance, and multiple saliva samples will be obtained each week for transcriptomic analysis, until infants have achieved full oral feeding status. At 18 months corrected age, infants will undergo neurodevelopmental follow-up testing, the results of which will be correlated with feeding outcomes in the neo-and post-natal period, gene expression data, and intervention status. Results: The ongoing NIH-funded RCT R01HD086088 is actively recruiting participants. The expected completion date of the study is 2021. Conclusions: N/A Clinical Trial: ClinicalTrials.gov NCT02696343; https://clinicaltrials.gov/ct2/show/NCT02696343

  • Mobile health technologies for palliative care patients at the interface of in-patient to outpatient care: A feasibility study aiming to early predict deterioration of patient’s health status

    Date Submitted: Mar 10, 2017

    Open Peer Review Period: Mar 20, 2017 - Apr 3, 2017

    Background: Palliative care patients are a particularly vulnerable population and one of the critical phases in patients’ trajectories is discharge from specialized in-patient palliative care into o...

    Background: Palliative care patients are a particularly vulnerable population and one of the critical phases in patients’ trajectories is discharge from specialized in-patient palliative care into outpatient care, where availability of a palliative care infrastructure is highly variable. A relevant number of potentially avoidable re-admissions and emergency visits of palliative patients is observed due to rapid exacerbation of symptoms indicating the need for a closer patient monitoring. In the last years, different mobile health technology applications have been evaluated in many different patient groups. Objective: The aim of our study is to test feasibility of a remote physical and social tracking system in palliative care patients. Methods: Feasibility study with explorative, descriptive study design, comprising three work packages. Thirty patients will be recruited on the wards of the Clinic of Radiation-Oncology at the University Hospital Zurich, including the specialized palliative care ward and will receive a smartphone and a tracking bracelet before discharge. Aim of work package A is to evaluate if severely ill patients accept to be equipped with a tracking bracelet and a smartphone (by semiquantitative questionnaires and guideline interviews). Work package B evaluates the technical feasibility and quality of the acquired electronic health data. Work package C will demonstrate whether physical activity parameters such as step count, sleep duration, social activity patterns like making calls, and vital signs, e.g. heart rate, do correlate with subjective health data and can serve as indicator to early detect and predict changes in patients’ health status. Activity parameters will be extracted from the smartphone’s and wristband’s sensor data using signal processing methods. Subjective health data is captured via electronic version of VAS and Distress Thermometer as well as the EORTC – QLQ C30 in paper version. Results: Not applicable Conclusions: Our project will deliver relevant data on patients’ acceptance of activity and social tracking and test the correlation between subjective symptom assessment and objective activity in the vulnerable population of palliative care patients. The proposed study is meant to be preparatory work for an intervention study to test the effect of wireless monitoring of palliative care patients on symptom control and quality of life. Clinical Trial: NCT03038841

  • Is there a necessity for routine radiograph on the first day postoperatively following open reduction and internal fixation for distal radius- and ankle fractures: study protocol for a prospective, open label, randomized controlled trial

    Date Submitted: Mar 15, 2017

    Open Peer Review Period: Mar 17, 2017 - Mar 31, 2017

    Distal radius and ankle fractures are one of the most common operatively treated fractures. To date there is no consensus concerning the need of a standard postoperative radiograph. This leads to unde...

    Distal radius and ankle fractures are one of the most common operatively treated fractures. To date there is no consensus concerning the need of a standard postoperative radiograph. This leads to undesirable practice variation. A standardised radiograph in the department of radiology would theoretically be more reproducible and operator independent than an intra-operatively obtained fluoroscopic image. It is questionable however, if adequate intra-operative radiographs have been obtained, if these postoperative radiographs are necessarily and will lead to changes in the treatment strategy. If standard postoperative radiographs are no longer required, this would lead to a reduction in radiation exposure and health care costs. The hypothesis is that routine standardised postoperative radiographs do not influence the quality of care for patients operated for distal radius- and ankle fracture if adequate intra-operative standardised radiographs have been obtained. The primary aim of this study is therefore to evaluate if there is a need for routine postoperative radiographs after an osteosynthesis for distal radius and ankle fractures. In a prospective, randomized controlled, open label trial based on a non-inferiority design we will enroll 332 patients. Patients will be randomized either in the control- or the intervention group. The control group will be treated according to our current, standard protocol in which all patients receive a standard radiograph in two directions on the first postoperative day. Patients randomized to the intervention group will be treated without a standard postoperative radiograph. All (332) patients will have a routine clinical and radiographic control after 6 weeks in the outpatient clinic. Primary outcome is a change in treatment plan, defined as either additional imaging or a reoperation based on the postoperative imaging. Secondary outcome measure includes a SF-36, PRWE, FOAS, VAS and the range of motion. Those questionnaires will be filled out at the 6 weeks outpatient control. Our findings will be reported in peer-reviewed publications and may lead to a strong reduction in radiation exposure and health care costs. A preliminary, conservative estimation including employed patients suggest a yearly cost saving of 1.3 Million Swiss Franc in Switzerland. Human Research Ethics approval has been obtained from the „Ethikkomission Nordwest- und Zentralschweiz (EKNZ). The commission accepted this trial on the 4th of April 2016 (EKNZ BASEC 2016-00114).

  • Study protocol for Power Up: A smartphone app to support young people to make shared decisions in therapy

    Date Submitted: Mar 14, 2017

    Open Peer Review Period: Mar 17, 2017 - Mar 31, 2017

    Background: Evidence suggests that young people want to be active participants in their care and involved in decisions about their treatment. However, there is a lack of digital shared decision-making...

    Background: Evidence suggests that young people want to be active participants in their care and involved in decisions about their treatment. However, there is a lack of digital shared decision-making tools available to support young people in Child and Adolescent Mental Health Services (CAMHS). Objective: The primary aim of this paper is to present the protocol of a feasibility trial of Power Up: a smartphone app to empower young people in CAMHS to make their voices heard and to participate in decisions around their care. Methods: In the development phase, 30 young people, parents and clinicians will take part in interviews and focus groups to elicit opinions on an early version of the app. In the feasibility testing phase, 120 young people from across seven London CAMHS services will take part in a trial, looking at the feasibility and acceptability of measuring the impact of Power Up on shared decision making. Results: Data collection for the development phase will take place between September 2016 and November 2016. Data collection for the feasibility testing phase will take place between January 2017 and August 2017. Conclusions: Findings will inform the planning of a cluster controlled trial and contribute to the development and implementation of a shared decision- making app to be integrated into CAMHS. Clinical Trial: The trial has been registered with the ISTCRN registry (ISRCTN77194423) and ClinicalTrials.gov (NCT02987608).

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