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:

  • Source, Copyright & License to use image purchased by authors.

    A Registry for Evaluation of Efficiency and Safety of Surgical Treatment of Cartilage Defects: The German Cartilage Registry (KnorpelRegister DGOU)

    Abstract:

    Background: The need for documentation in cartilage defects is as obvious as in other medical specialties. Cartilage defects can cause significant pain, and lead to reduced quality of life and loss of function of the affected joint. The risk of developing osteoarthritis is high. Therefore, the socioeconomic burden of cartilage defects should not be underestimated. Objective: The objective of our study was to implement and maintain a registry of all patients undergoing surgical treatment of cartilage defects. Methods: We designed this multicenter registry for adults whose cartilage defects of a knee, ankle, or hip joint are treated surgically. The registry consists of two parts: one for the physician and one for the patient. Data for both parts will be gathered at baseline and at 6-, 12-, 24-, 36-, 60-, and 120-month follow-ups. Results: To date, a wide range of German, Swiss, and Austrian trial sites are taking part in the German Cartilage Registry, soon to be followed by further sites. More than 2124 (as of January 31, 2016) cases are already documented and the first publications have been released. Conclusions: The German Cartilage Registry addresses fundamental issues regarding the current medical care situation of patients with cartilage defects of knee, ankle, and hip joints. In addition, the registry will help to identify various procedure-specific complications, along with putative advantages and disadvantages of different chondrocyte products. It provides an expanding large-scale, unselected, standardized database for cost and care research for further retrospective studies. Trial Registration: German Clinical Trials Register: DRKS00005617; https://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005617 (Archived by WebCite at http://www.webcitation.org/6hbFqSws0)

  • Central hemodynamics and wave reflections assessment at rest in the VASOTENS Registry prior to starting 24-hour ABPM. Source and copyright: the authors.

    Vascular Health Assessment of The Hypertensive Patients (VASOTENS) Registry: Study Protocol of an International, Web-Based Telemonitoring Registry for...

    Abstract:

    Background: Hypertension guidelines recommend ambulatory blood pressure (ABP), central aortic pressure (CAP), and pulse wave velocity (PWV) as parameters for estimating blood pressure (BP) control and vascular impairment. Recent advances in technology have enabled devices to combine non-invasive estimation of these parameters over the 24-hour ABP monitoring. However, currently there is limited evidence on the usefulness of such an approach for routine hypertension management. Objective: We recently launched an investigator-initiated, international, multicenter, observational, prospective study, the Vascular health Assessment Of The Hypertensive patients (VASOTENS) Registry, aimed at (1) evaluating non-invasive 24-hour ABP and arterial stiffness estimates (through 24-hour pulse wave analysis, PWA) in hypertensive subjects undergoing ambulatory blood pressure monitoring (ABPM) for clinical reasons; (2) assessing the changes in estimates following treatment; (3) weighing the impact of 24-hour PWA on target organ damage and cardiovascular prognosis; (4) assessing the relationship between arterial stiffness, BP absolute mean level and variability, and prognosis; and (5) validating the use of a 24-hour PWA electronic health (e-health) solution for hypertension screening. Methods: Approximately 2000 subjects, referred to 20 hypertension clinics for routine diagnostic evaluation and follow-up of hypertension of any severity or stage, will be recruited. Data collection will include ABPM, performed with a device allowing simultaneous non-invasive assessment of 24-hour CAP and arterial stiffness (BPLab), and clinical data (including cardiovascular outcomes). As recommended by current guidelines, each patient will be followed-up with visits occurring at regular intervals (ideally every 6 months, and not less than once a year depending on disease severity). A Web-based telemedicine platform (THOLOMEUS) will be used for data collection. The use of the telemedicine system will allow standardized and centralized data collection, data validation by experts and counseling to remote centers, setup and maintenance of the Registry, and prompt data analysis. Results: First follow-up results are expected to be available in the next 2 years. Conclusions: The results of the VASOTENS Registry will help define the normalcy thresholds for current and future indices derived from 24-hour PWA, according to outcome data, and will also provide supporting evidence for the inclusion of this type of evaluation in hypertension management. Trial registration: Clinicaltrials.gov NCT02577835; https://clinicaltrials.gov/ct2/show/NCT02577835 (Archived by WebCite at http://www.Webcitation.org/6hzZBKY2Q)

  • http://trekk.ca/
Copyright © 2013 Trekk. All Rights Reserved.

    Feasibility of an Electronic Survey on iPads with In-Person Data Collectors for Data Collection with Health Care Professionals and Health Care Consumers in...

    Abstract:

    Background: Translating Emergency Knowledge for Kids was established to bridge the research-practice gap in pediatric emergency care by bringing the best evidence to Canadian general emergency departments (EDs). The first step in this process was to conduct a national needs assessment to determine the information needs and preferences of health professionals and parents in this clinical setting. Objective: To describe the development and implementation of two electronic surveys, and determine the feasibility of collecting electronic survey data on iPads with in-person data collectors in a busy clinical environment. Methods: Two descriptive surveys were conducted in 32 general EDs. Specific factors were addressed in four survey development and implementation stages: survey design, survey delivery, survey completion, and survey return. Feasibility of the data collection approach was determined by evaluating participation rates, completion rates, average survey time to completion, and usability of the platform. Usability was assessed with the in-person data collectors on five key variables: interactivity, portability, innovativeness, security, and proficiency. Results: Health professional participation rates (1561/2575, 60.62%) and completion rates (1471/1561, 94.23%) were strong. Parental participation rates (974/1099, 88.63%) and completion rates (897/974, 92.09%) were excellent. Mean time to survey completion was 28.08 minutes for health professionals and 43.23 minutes for parents. Data collectors rated the platform “positively” to “very positively” on all five usability variables. Conclusions: A number of design and implementation considerations were explored and integrated into this mixed-mode survey data collection approach. Feasibility was demonstrated by the robust survey participation and completion rates, reasonable survey completion times, and very positive usability evaluation results.

  • Cellphones. Image created and copyright owned by authors Deepthi Satheesa Varma et al.

    A Research Protocol to Test the Effectiveness of Text Messaging and Reminder Calls to Increase Service Use Referrals in a Community Engagement Program

    Abstract:

    Background: Mobile phoned–based interventions have been increasingly used in clinical populations to improve health and health care delivery. The literature has shown that mobile phone–based text messages (short message service, SMS) are instantaneous, cost effective, and have less chance of being misplaced. Studies using mobile phone based–text messages have reported text messages as effective reminders that have resulted in increased appointment attendance, adherence to treatment, and better self-management. There have been no reports of adverse events when using text messaging in terms of misreading or misinterpreting data, transmitting inaccurate data, losing verbal or nonverbal communication cues, privacy issues, or failure or delay in message delivery. However, the literature has cited a need for personalized messages that are more responsive to individual needs. In addition, there has been a dearth of information on the use of reminders in nonclinical populations. Objective: The goal of this study is to assess the effectiveness of adding reminders in the form of text messaging versus reminder calls versus text messages and reminder calls to increase use of service referrals provided through community outreach. Methods: A total of 300 participants will be recruited for the study. Each participant will be randomized to one of three arms: a group that receives only reminder calls (CALLSONLY); a group that receives only text message reminders (TEXTONLY); and a group that receives both reminder calls and text messages (CALLS+TEXT). All groups will receive their reminder intervention on the 15th and 45th day after baseline when they receive medical and social service referrals from the community health workers (CHWs). A standard script will be used to administer the call and text reminders and a 15-item telephone-based satisfaction survey will be administered to assess the participant satisfaction with the process of receiving periodic reminders. Results: The study is in the recruitment and follow-up phase. The authors anticipate completion of recruitment, interventions, and data entry by July 2016. Preliminary results are expected to be available by September 2016. Conclusions: This study will provide an opportunity to test the effectiveness of mobile-based interventions on nonclinical, community-recruited populations. In particular, such a protocol would increase the effectiveness of a community-based engagement program by instating a formal reminder system for all program members who receive social and/or medical service referrals during outreach in the community. Findings from this study would guide the development and implementation of reminder protocols for community-based engagement programs nationwide.

  • Image Source: Golimumab, copyright AIRE Marina Baixa,
https://www.youtube.com/watch?v=UO8ftTdlP2M, Standard YouTube License.

    Early Monitoring of Response (MORE) to Golimumab Therapy Based on Fecal Calprotectin and Trough Serum Levels in Patients With Ulcerative Colitis: A...

    Abstract:

    Background: The treatment of ulcerative colitis (UC) patients with moderate to severe inflammatory activity with anti-tumor necrosis factor alpha (TNFα) antibodies leads to a clinical remission rate of 10% after 8 weeks of therapy. However, it must be taken into account that patient selection in clinical trials clearly influences both response and remission rates. An unsatisfactory response to anti-TNFα medication after week 12 often leads to a discontinuation of treatment. The early prediction of clinical response could therefore help optimize therapy and potentially avoid ineffective treatments. Objective: The aim of this study is to develop an algorithm for optimizing golimumab administration in patients with moderate to severe UC by calculating the probability of clinical response in Week 26 based on data from Week 6. Methods: The study is designed as a prospective, single-arm, multicenter, non-interventional observational study with no interim analyses and a sample size of 58 evaluable patients. The primary outcome is the prediction of clinical response in Week 26 based on a 50% reduction in fecal calprotectin and a positive golimumab trough level in Week 6. Results: Enrollment started in October 2014 and was still open at the date of submission. The study is expected to finish in December 2016. Conclusions: The early identification of patients who are responding to an anti-TNFα antibody is therapeutically beneficial. At the same time, patients who are not responding can be identified earlier. The development of a therapeutic algorithm for identifying patients as responders or non-responders can thus help prescribing physicians to both avoid ineffective treatments and adjust dosages when necessary. This in turn promotes a higher degree of treatment tolerance and patient safety in the case of anti-TNFα antibody administration. ClinicalTrial: German Clinical Trials Register, Deutsches Register Klinischer Studien DRKS00005940; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005940 (Archived by WebCite at http://www.webcitation.org/6i4Xoo1sH)

  • Photo for #5653 TOC

Source URL information: http://www.shutterstock.com/pic-396467920/stock-photo-guy-holding-the-phone-listening-to-music.html?src=rXks8U8mdtf2YBX7r0WOuA-1-14.

    The SmokefreeTXT (SFTXT) Study: Web and Mobile Data Collection to Evaluate Smoking Cessation for Young Adults

    Abstract:

    Background: Text messaging (short message service, SMS) has been shown to be effective in delivering interventions for various diseases and health conditions, including smoking cessation. While there are many published studies regarding smoking cessation text messaging interventions, most do not provide details about the study’s operational methods. As a result, there is a gap in our understanding of how best to design studies of smoking cessation text messaging programs. Objective: The purpose of this paper is to detail the operational methods used to conduct a randomized trial comparing three different versions of the National Cancer Institute’s SmokefreeText (SFTXT) program, designed for smokers 18 to 29 years of age. We detail our methods for recruiting participants from the Internet, reducing fraud, conducting online data collection, and retaining panel study participants. Methods: Participants were recruited through website advertisements and market research online panels. Screening questions established eligibility for the study (eg, 18 to 29 years of age, current smoker). Antifraud measures screened out participants who could not meet the study requirements. After completing a baseline survey, participants were randomized to one of three study arms, which varied by type and timing of text message delivery. The study offered US $20 gift cards as incentives to complete each of four follow-up surveys. Automated email reminders were sent at designated intervals to increase response rates. Researchers also provided telephone reminders to those who had not completed the survey after multiple email reminders. We calculated participation rates across study arms and compared the final sample characteristics to the Current Population Survey to examine generalizability. Results: Recruitment methods drove 153,936 unique visitors to the SFTXT Study landing page and 27,360 began the screener. Based on the screening questions, 15,462 out of 27,360 responders (56.51%) were eligible to participate. Of the 15,462 who were eligible, 9486 passed the antifraud measures that were implemented; however, 3882 failed to verify their email addresses or cell phone numbers, leaving 5604 who were invited to complete the baseline survey. Of the 5604 who were invited, 4432 completed the baseline survey, but only 4027 were retained for analysis because 405 did not receive the intervention. Conclusions: Although antifraud measures helped to catch participants who failed study requirements and could have biased the data collected, it is possible that the email and cell phone verification check excluded some potentially eligible participants from the study. Future research should explore ways to implement verification methods without risking the loss of so many potential participants. ClinicalTrial: Clinical Trials.gov NCT01885052; https://clinicaltrials.gov/ct2/show/NCT01885052; (Archived by WebCite at http://www.webcitation.org/6iWzcmFdw)

  • Image retrieved from: https://www.pexels.com/photo/notebook-working-macbook-technology-34125/. Licensed under Creative Commons Attribution cc-by 2.0 https://creativecommons.org/licenses/by/2.0/.

    Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol

    Abstract:

    Background: Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Objective: Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. Methods: The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care–related infections were reviewed to develop the infection control protocol to support tablet maintenance. Results: This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. Conclusions: These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

  • picture of monitor and phone. Image sourced, modified and copyright owned by authors.

    Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial

    Abstract:

    Background: Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving “optimal BP control” (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring—the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. Objective: To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with “enhanced usual care” in community-dwelling seniors with diabetes and hypertension. Methods: A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors’ residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Results: Outcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ≥80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers. Conclusion: The potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada. Trial Registration: Clinicaltrials.gov NCT02721667; https://clinicaltrials.gov/ct2/show/NCT02721667 (Archived by Webcite at http://www.webcitation.org/6i8tB20Mc)

  • Soure: http://preview.tinyurl.com/j2aa7wj; CC0 Public Domain.

    Supporting Goal-Oriented Primary Health Care for Seniors with Complex Care Needs Using Mobile Technology: Evaluation and Implementation of the Health System...

    Abstract:

    Background: Older adults experiencing multiple chronic illnesses are at high risk of hospitalization and health decline if they are unable to manage the significant challenges posed by their health conditions. Goal-oriented care approaches can provide better care for these complex patients, but clinicians find the process of ascertaining goals “too complex and too-time consuming,” and goals are often not agreed upon between complex patients and their providers. The electronic patient reported outcomes (ePRO) mobile app and portal offers an innovative approach to creating and monitoring goal-oriented patient-care plans to improve patient self-management and shared decision-making between patients and health care providers. The ePRO tool also supports proactive patient monitoring by the patient, caregiver(s), and health care provider. It was developed with and for older adults with complex care needs as a means to improve their quality of life. Objective: Our proposed project will evaluate the use, effectiveness, and value for money of the ePRO tool in a 12-month multicenter, randomized controlled trial in Ontario; targeting individuals 65 or over with two or more chronic conditions that require frequent health care visits to manage their health conditions. Methods: Intervention groups using the ePRO tool will be compared with control groups on measures of quality of life, patient experience, and cost-effectiveness. We will also evaluate the implementation of the tool. Results: The proposed project presented in this paper will be funded through the Canadian Institute for Health Research (CIHR) eHealth Innovation Partnerships Program (eHIPP) program (CIHR–348362). The expected completion date of the study is November, 2019. Conclusions: We anticipate our program of work will support improved quality of life and patient self-management, improved patient-centered primary care delivery, and will encourage the adoption of goal-oriented care approaches across primary health care systems. We have partnered with family health teams and quality improvement organizations in Ontario to ensure that our research is practical and that findings are shared widely. We will work with our established international network to develop an implementation framework to support continued adaptation and adoption across Canada and internationally.

  • Image Source: Cynthia Text Messaging Something Funny, copyright Kevin Stephenson,
http://tinyurl.com/h3wjqdl,
Licensed under Creative Commons Attribution cc-by 2.0 https://creativecommons.org/licenses/by/2.0/.

    A Cognitive Behavioral Therapy–Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot...

    Abstract:

    Background: Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise. Objective: Mobile phone–based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders. Methods: With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users. Results: The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year. Conclusions: This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users.

  • Screen of the homepage, showing the nine modules of the online Reuma Uitgedaagd! (in Dutch). Source and copyright: the authors.

    Building a Tailored, Patient-Guided, Web-Based Self-Management Intervention ‘ReumaUitgedaagd!’ for Adults With a Rheumatic Disease: Results of a...

    Abstract:

    Background: The chronic nature of rheumatic diseases imposes daily challenges upon those affected and causes patients to make daily decisions about the way they self-manage their illness. Although there is attention to self-management and evidence for the desirability of tailored interventions to support people with a rheumatic disease, interventions based on individual needs and preferences are scarce. Objective: To provide a systematic and comprehensive description of the theoretical considerations for building a Web-based, expert, patient-guided, and tailored intervention for adult patients with a rheumatic disease. Also, to present the results of a usability study on the feasibility of this intervention, and its study design in order to measure the effectiveness. Methods: To fit the intervention closely to the autonomy, needs, and preferences of the individual patient, a research team comprising patient representatives, health professionals, Web technicians, and communication experts was formed. The research team followed the new guidance by the Medical Research Council (MRC) for developing and evaluating complex interventions as a guide for the design of the intervention. Results: Considerations from self-determination theory and a comprehensive assessment of preferences and needs in patients with a rheumatic disease guided the development of the Web-based intervention. The usability study showed that the intervention was useful, easy to use, and accepted and appreciated by the target group of patients. The planned randomized controlled trial is designed to be conducted among 120 adults with a rheumatic disease, who are assigned to the self-management intervention or a self-help control group. Both groups will be asked to formulate personal goals they want to achieve concerning their self-management. Progress toward the personal goal is the primary outcome measure of this study. Self-reported Web-based measures will be assessed before randomization at baseline, and 3 and 6 months after randomization. Also, feasibility and adherence to the Web-based self-management intervention as process outcomes will be evaluated. Conclusion: By identifying the individual goals at the beginning of the intervention and customizing the intervention to the individual patient, we aim to improve the usefulness and effectiveness of the Web-based self-management intervention. If proven effective, ReumaUitgedaagd! Online will be implemented in the Netherlands.

  • Image Source: Mi Preciosa, copyright Tobias Lindman,
http://tinyurl.com/hedcxcv,
Licensed under Creative Commons Attribution cc-by 2.0 https://creativecommons.org/licenses/by/2.0/.

    A Mixed-Method Study to Determine the Benefits of Periconceptional Folic Acid Supplementation and Effects of Folic Acid Deficiency in Mothers on Birth Outcomes

    Abstract:

    Background: Evidence from high income countries shows mothers who are supplemented with folic acid in their periconceptional period and early pregnancy have significantly reduced adverse outcomes like birth defects. However, in India there is a paucity of data on association of birth defects and folic acid supplementation. We identified a few important questions to be answered using separate scientific methods and then planned to triangulate the information. Objective: In this paper, we describe the protocol of our study that aims to determine the association of folic acid and pregnancy outcomes like neural tube defects (NTDs) and orofacial clefts (OFCs). We decided to fill the gaps in knowledge from India to determine public health consequences of folic acid deficiency and factors influencing dietary and periconceptional consumption of folic acid. Methods: The proposed study will be carried out in five stages and will examine the questions related to folic acid deficiency across selected locations in South and North India. The study will be carried out over a period of 4 years through the hierarchical evidence-based approach. At first a systematic review was conducted to pool the current birth prevalence of NTDs and orofacial clefts OFCs in India. To investigate the population prevalence, we plan to use the key informant method to determine prevalence of NTDs and OFCs. To determine the normal serum estimates of folic acid, iron, and vitamin B12 among Indian women (15-35 years), we will conduct a population-based, cross-sectional study. We will further strengthen the evidence of association between OFCs and folic acid by conducting a hospital-based, case-control study across three locations of India. Lastly, using qualitative methods we will understand community and health workers perspective on factors that decide the intake of folic acid supplements. Results: This study will provide evidence on the community prevalence of birth defects and prevalence folic acid and vitamin B12 deficiency in the community. The case-control study will help understand the association of folic acid deficiency with OFCs. Conclusions: The results from this study are intended to strengthen the evidence base in childhood disability for planning and policy initiatives.

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  • Examining incentives to promote physical activity among hospital employees not achieving 10,000 daily steps: A web-based randomized control trial protocol

    Date Submitted: Jun 28, 2016

    Open Peer Review Period: Jun 29, 2016 - Jul 13, 2016

    Background: The economic burden of physical inactivity in Canada is estimated at $6.8 billion/year. Employers bear a substantial proportion of the economic costs, as they pay more for inactive worker...

    Background: The economic burden of physical inactivity in Canada is estimated at $6.8 billion/year. Employers bear a substantial proportion of the economic costs, as they pay more for inactive workers in health care, disability, and absenteeism expenses. In response, many Canadian employers offer wellness programs to help address this issue. Wellness programs, however, are chronically underutilized. Financial health incentives have been proposed as one strategy to increase participation. Objective: To outline the methodology for a randomized control trial (RCT) examining the impact of minimal “uncertain chance” incentives (standard care) versus an enhanced incentive program (standard care plus “assured” incentives; intervention) on physical activity in a “lower active” (< 10,000 daily steps at baseline) hospital employee population. Methods: A 12-week, parallel arm, RCT will be employed. Employees using Change4Life (a fully automated, web- and incentive-based wellness program) and accumulating fewer than 10,000 steps per day at baseline (Weeks 1 to 2) will be randomly allocated (1:1) to standard care (wellness program, StepsCount Piezo®Rx accelerometer, “uncertain chance” incentives) or an intervention group (standard care plus “assured” incentives). All study participants will be asked to wear the accelerometer and synchronize it to Change4Life daily, though only intervention group participants will receive “assured” incentives for reaching tailored daily step count goals ($1 per day; Weeks 3 to 12). The primary study outcome will be mean proportion of participants achieving daily step goals during Study Week 12. Volume of steps per day will be a secondary outcome, as well as the mean proportion of participant days step goals are reached during the post-intervention follow-up (Study Week 24). Results: Recruitment for this study will begin September 2016. Conclusions: This protocol was designed to examine the impact of adding “assured” rewards to a minimal “uncertain chance” incentive program on physical activity and sustained behaviour change in lower active hospital employees. Clinical Trial: ClinicalTrials.gov NCT02638675; https://clinicaltrials.gov/ct2/show/NCT0 2638675 (Archived by WebCite at http://www.webcitation.org/6g4pvZvhW)

  • Protocol for a systematic review and meta-analysis to reliability quantify the potential for equations based upon spot urine samples to estimate population salt intake

    Date Submitted: Jun 28, 2016

    Open Peer Review Period: Jun 29, 2016 - Jul 13, 2016

    Background: Methods based on spot urine samples have been identified as a possible alternative approach to 24-hour urine collections for determining mean population salt intake. Objective: To identify...

    Background: Methods based on spot urine samples have been identified as a possible alternative approach to 24-hour urine collections for determining mean population salt intake. Objective: To identify the best method for estimating mean population salt intake from spot urine samples. This will be done by comparing the performance of existing equations against each other and against estimates derived from 24-hour urine collections. The effects of factors such as ethnicity, sex, age, antihypertensive drug use, health status and timing of spot urine collection will be explored. The capacity of spot urine samples to measure change in salt intake over time will also be determined. Methods: A systematic review and meta-analysis of individual participant data will be conducted. A search has been conducted to identify human studies that report salt (or sodium) excretion based upon 24-hour urine samples and spot urine samples. There were no restrictions on language, study sample size or characteristics of the study population. MEDLINE via OvidSP (1946 - present), Premedline via OvidSP, EMBASE, Global Health via OvidSP (1910 - present) and the Cochrane Library were searched and two reviewers identified eligible studies. The authors of these studies will be invited to contribute data according to a standard format. The individual participant records will be compiled and a series of analyses will be completed to: 1) compare existing equations for estimating 24-hour salt intake from spot urine samples with 24- hour urine samples, and assess the degree of bias according to key demographic and clinical characteristics; 2) assess the reliability of using spot urine samples to measure population changes in salt intake overtime; 3) develop a novel equation that performs better than existing equations to estimate mean population salt intake. Results: The search strategy identified 538 records and of these records 100 were obtained for review in full text and 73 have been confirmed eligible. In addition, 68 abstracts were identified which may contain data eligible for inclusion. Individual participant data will be requested from authors of eligible studies. Conclusions: Many equations for estimating salt intake from spot urine samples have been developed and validated although mostly in very specific settings. This meta-analysis of individual participant data will enable a much broader understanding of the capacity for spot urine samples to estimate population salt intake.

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    Open Peer Review Period: Jun 28, 2016 - Jul 12, 2016

    Background: MLC601 (NeuroAiD), a combination of natural products, has been shown to be safe and to aid neurological recovery after brain injuries. Spinal cord injury (SCI) is a devastating condition w...

    Background: MLC601 (NeuroAiD), a combination of natural products, has been shown to be safe and to aid neurological recovery after brain injuries. Spinal cord injury (SCI) is a devastating condition with limited therapeutic options. Objective: The primary objective of this study is to evaluate the safety and the potential efficacy of NeuroAiD in SCI. Methods: SATURN is a prospective cohort study of patients with moderately-severe to severe SCI, defined as American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B. These patients will be treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 and will include information on demographics, main diagnostics, neurological and functional state assessed by the Spinal Cord Independence Measure (SCIM), ASIA -International Standard for Neurological Classification Spinal Cord Injury (ISNCSCI) and Short Form (SF)-8 Health Survey. In addition, NeuroAiD treatment, compliance, concomitant therapies, and side effects, if any will be collected. Investigators will use a secured online system for data entry. The study is approved by the ethic committee of Hospital University Kebangsaan Malaysia. Results: The co-primary endpoints are safety, AIS grade, and improvement in ASIA motor score at 6 months. Secondary endpoints are AIS grade, ASIA motor scores and sensory scores, SCIM, SF-8 Health Survey, and compliance at other time points. Conclusions: SATURN investigated the promising role of NeuroAiD in SCI especially given its excellent safety profile. We described here the protocol and online data collection tool we will use for a prospective cohort of patients with moderately severe to severe SCI treated with NeuroAiD. The results will provide important information on the feasibility of conducting larger controlled trials. Clinical Trial: www.clinicaltrials.gov NCT02537899

  • Partner Steps: a dyadic behavioral intervention to optimize same sex male couples’ engagement across the HIV care continuum

    Date Submitted: Jun 27, 2016

    Open Peer Review Period: Jun 27, 2016 - Jul 11, 2016

    Background: An estimated one- to two-thirds of new HIV infections among U.S. MSM occur within the context of primary partnerships. Thus, HIV interventions that recognize and harness the power of relat...

    Background: An estimated one- to two-thirds of new HIV infections among U.S. MSM occur within the context of primary partnerships. Thus, HIV interventions that recognize and harness the power of relationships are needed. Increasingly, HIV prevention efforts are being directed towards improving engagement across the HIV care continuum from testing to linkage to care, antiretroviral therapy (ART) adherence, engagement in care, and viral suppression. However, no behavioral interventions to our knowledge have attempted to address the HIV care continuum using a dyadic approach. Objective: The objective of this paper is to describe the development of and protocol for an innovative couples-based approach to improving treatment adherence and engagement in care among HIV serodiscordant and concordant HIV-positive same sex male couples in the United States. Methods: We developed the Partner Steps intervention by drawing from relationship-oriented theory, existing efficacious individual-level ART adherence interventions, couple-focused HIV prevention interventions, and expert consultation. We incorporated new content to address all aspects of the HIV care continuum (e.g., linkage to and retention in care) and to draw on relationship strengths through interactive activities. Results: The resulting theory-based Partner Steps intervention is delivered by a trained bachelors-level counselor (interventionist) over two in-person sessions with male-male dyads in which at least one partner has recent suboptimal engagement in HIV care. Each session is designed to utilize relationship strengths to increase motivation for HIV care and treatment, and cover sequential intervention “steps” relating to specific challenges in HIV care engagement and barriers to ART adherence. For each step, couples work with a trained interventionist to identify their unique challenges, actively problem-solve with the interventionist, and articulate and commit to working together to implement a plan in which each partner agrees to complete specific tasks. Conclusions: We drew on theory and evidence to develop novel intervention strategies that leverage strengths of relationships to address engagement across the entire HIV care continuum. We provide details on intervention development and content that may be of use to researchers as well as medical and mental health professionals for whom a dyadic approach to HIV prevention and care may best suit their patient population.

  • A Pilates exercise program for improving core strength, balance and functional autonomy in aged women: study protocol for a randomised controlled trial

    Date Submitted: Jun 22, 2016

    Open Peer Review Period: Jun 26, 2016 - Jul 10, 2016

    Background: Spain is one of the oldest countries of the European Union with a major proportion of women in the older age group. Consequently, there is a need to identify and implement effective strate...

    Background: Spain is one of the oldest countries of the European Union with a major proportion of women in the older age group. Consequently, there is a need to identify and implement effective strategies to ensure their independence to achieve typical activities of daily living. Core training is becoming a novel approach for enhancing strength, balance, functional autonomy, and preventing falls among elderly. However, real life conditions require concurrent attention-demanding tasks, increasing the risk of falling and contributing to disability. Objective: Pilates-based exercise is proposed as a combined core and mental training program grounded on learning functionally effective postural sets and motor patterns, that will provide better results than a muscular exercise program in older women trunk strength and other complementary physical and mental functions such as balance or functional autonomy. Methods: This is a 34-week randomised controlled trial in which 80 independent older women will be allocated to a Pilates-based exercise program, a muscular exercise program, or a no-exercise control group. The intervention will be divided into 22 weeks of supervised exercise and a 12 weeks follow-up. The primary outcome will be isokinetic and isometric trunk and hip flexion-extension strength. The secondary outcome will include static and dynamic balance, the number of falls, functional autonomy, body composition, habitual physical activity and a standardized gerontological evaluation. Every item will be measured at baseline and after 22 and 34 weeks. Results: Recruitment process is currently accomplished. Pilates and Muscular exercise programs logistics are ready to begin their implementation. Results are expected in 2017. Conclusions: We expect that our results will guide other exercise-based strategies to implement combined core and mental training programs as a better way to enhance trunk strength, balance and functional autonomy, to diminish the risk of falling and preserve functionality in aged women. In addition, the follow-up period will provide new relevant information about the efficacy of the learning process included in Pilates-based exercise. Clinical Trial: NCT02506491

  • Rationale and design of Genetic study in Cardio-Metabolic risk factors: Tehran Cardio-Metabolic Genetic Study (TCGS)

    Date Submitted: Jun 4, 2016

    Open Peer Review Period: Jun 26, 2016 - Jul 10, 2016

    Background: Nowadays cardio-metabolic risk factors comprise cardiovascular diseases and/or diabetes and need to be evaluated in different fields. The primary aim of the Tehran Cardiometabolic Genetic...

    Background: Nowadays cardio-metabolic risk factors comprise cardiovascular diseases and/or diabetes and need to be evaluated in different fields. The primary aim of the Tehran Cardiometabolic Genetic Study (TCGS) is to create a comprehensive genome-wide database of at least 16 000 Tehranians, participants of the ongoing Tehran lipid and glucose study (TLGS) cohort. Objective: We aimed to undertake a genome wide association study evaluating and comparing genetic patterns in a Tehranian population to other reference genetic databases. This is one of the very first studies of its kind in the Middle East, and addresses the knowledge gap on the allele frequency, genetic association and the role of consanguineous marriage among Iranian families. Methods: TCGS was designed in collaboration with the Research Institute for Endocrine Sciences (RIES) and DeCode genetic company. Participants selected had already been followed for over a 16-years period for major incident cardio-metabolic related health events including; myocardial infarction, stroke, diabetes mellitus, hypertension, obesity, hyperlipidemia and familial hypercholesterolemia. Results: The TCGS cohort described here comprises 16,247 (76.58%) of the 21,216 TLGS participants who provided a baseline blood sample adequate for plasma and DNA analysis. 3937 families were collected and the mean pedigree size in population of study was 6.76 range 3 to 52. Finally 5201 males and 6296 females with the total genotyping rate of 0.9836 were genotyped with HumanOmniExpress-24-v1-0 bead chips (containing 715,871 SNP loci with an average mean distance of 4 kb). Conclusions: Investigations conducting within the TCGS will seek to identify relevant patterns of genetic polymorphism that could be related to cardio-metabolic risk factors in Tehran’s participants. By linking genome-wide data to the existing databank of TLGS participant, which includes comprehensive behavioral, biochemical and clinical data on each participant since cohort inception in 1999, the TCGS will also allow exploration of gene-gene and gene-environment interactions as they relate to disease status.

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