JMIR Publications

JMIR Research Protocols

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


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: 4.7)
  • 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:

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    Digital Gaming for Improving the Functioning of People With Traumatic Brain Injury: Protocol of a Feasibility Study


    Background: Traumatic brain injury (TBI) is a critical public health problem. The recovery process for people with TBI is typically slow and dependent on complex and intensive assisted rehabilitation programs. Objective: To evaluate the effects and feasibility of digital games for cognitive functioning and general well-being among people with traumatic brain injury. Methods: This is a single-site feasibility study conducted in Finland, which uses a pragmatic, randomized controlled trial with three arms, and will recruit patients from the Turku University Hospital, Division of Clinical Neurosciences in Finland. Participants must meet the following inclusion criteria: (1) a Finnish speaking adult, aged 18-65 years; (2) diagnosed with a traumatic brain injury (diagnostic criteria ICD-10, S06.X, T90.5) in the University Hospital; (3) access to a TV, a computer, and the Internet at home; (4) not an active digital gamer (5 hours or less a week); (5) willing to participate in the study. Participants must have been discharged from the neurologic treatment period for traumatic brain injury for over 12 months before the commencement of the trial, and they may not have actively participated in cognitive rehabilitation during the 3 months prior to the trial. Written informed consent will be mandatory for acceptance into the trial. Exclusion criteria are as follows: (1) sensory, cognitive, or physical impairment (eg, severe cognitive impairment); (2) a deficiency restricting the use of computers or computer game control system unaided (eg, impairment in vision, severe astigmatism, hemiplegia, disorder in visuospatial perception, dysfunction of the central vestibular system); (3) apathy identified in previous neuropsychological evaluations; (4) diagnosed severe mental disorders (eg, schizophrenia or severe depressive disorders to be identified in medical records as the secondary diagnosis). Results: The preparatory phase for the study is fulfilled. Recruitment started in June 2015 and finished November 2015. Results will be reported in 2016. Conclusions: The specific outcomes such as primary outcome measures were selected because they are widely used psychological tests and thought to be sensitive to changes in the cognitive functions related to TBI. Trial Registration: NCT02425527; (Archived by WebCite at

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    Multiple Sclerosis Therapy With Disease-Modifying Treatments in Germany: The PEARL (ProspEctive phArmacoeconomic cohoRt evaluation) Noninterventional Study...


    Background: Patients with multiple sclerosis (MS) require long-term therapy and have a wide variety of needs for health-related support. The efficacy and safety of MS therapy, as assessed by both clinicians and patients, are important parameters that need to be considered. However, few studies combine data on efficacy and safety outcomes with pharmacoeconomic data. Objective: Here, we present the study design of the ProspEctive phArmacoeconomic cohoRt evaluation (PEARL), a prospective, multicenter, noninterventional cohort study on patients with relapsing-remitting MS (RRMS) treated with disease-modifying treatments (DMTs). Methods: During a prospective observational phase of 24 months per patient, PEARL evaluated clinical and patient-perceived efficacy and safety measures, as well as pharmacoeconomic data on RRMS patients treated with DMTs—interferon beta and glatiramer acetate. Measurements of the patients' perceptions included the assessment of patient-reported quality of life, treatment satisfaction, and compliance. The study was planned to include 1800 outpatients from 180 German neurological practices who had continuously been treated with an approved DMT for at least 30 days. The primary statistical analyses of the PEARL study will be descriptive. Particular focus will be on specific subgroups, such as patients who switched DMTs during therapy and patients with disease worsening or disease activity. Subgroups will be compared using stratified analyses. Results: Data collection for PEARL started in September 2010 and ended in July 2013. As of July 2015, the study is completed and is currently being analyzed and written up. Conclusions: PEARL is evaluating both the health status and resource utilization of RRMS patients treated with DMTs in Germany. The combination of pharmacoeconomic data with clinical and patients' self-perceived efficacy and safety outcomes will add useful information to the currently incomplete picture of the overall RRMS burden in Germany.

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    Benefits of E-Cigarettes Among Heavy Smokers Undergoing a Lung Cancer Screening Program: Randomized Controlled Trial Protocol


    Background: Smoking is a global public health problem. For this reason, experts have called smoking dependence a global epidemic. Over the past 5 years, sales of electronic cigarettes, or e-cigarettes, have been growing strongly in many countries. Yet there is only partial evidence that e-cigarettes are beneficial for smoking cessation. In particular, although it has been proven that nicotine replacement devices may help individuals stop smoking and tolerate withdrawal symptoms, e-cigarettes’ power to increase the quitting success rate is still limited, ranging from 5% to 20% dependent on smokers’ baseline conditions as shown by a recent Cochrane review. Consequently, it is urgent to know if e-cigarettes may have a higher success rate than other nicotine replacement methods and under what conditions. Furthermore, the effects of the therapeutic setting and the relationship between individual characteristics and the success rate have not been tested. This protocol is particularly innovative, because it aims to test the effectiveness of electronic devices in a screening program (the COSMOS II lung cancer prevention program at the European Institute of Oncology), where tobacco reduction is needed to lower individuals’ lung cancer risks. Objective: This protocol was designed with the primary aim of investigating the role of tobacco-free cigarettes in helping smokers improve lung health and either quit smoking or reduce their tobacco consumption. In particular, we aim to investigate the impact of a 3-month e-cigarettes program to reduce smoking-related respiratory symptoms (eg, dry cough, shortness of breath, mouth irritation, and phlegm) through reduced consumption of tobacco cigarettes. Furthermore, we evaluate the behavioral and psychological (eg, well-being, mood, and quality of life) effects of the treatment. Methods: This is a prospective, randomized, placebo-controlled, double-blind, three-parallel group study. The study is organized as a nested randomized controlled study with 3 branches: a nicotine e-cigarettes group, a nicotine-free e-cigarettes group, and a control group. The study is nested in a screening program for early lung cancer detection in heavy smokers. Results: The study is open and is still recruiting. Conclusions: Stopping or reducing tobacco consumption should be a main goal of any health organization. However, traditional antismoking programs are expensive and not always effective. Therefore, favoring a partial or complete shift to e-cigarettes in heavy smokers (eg, persons at high risk for a number of diseases) could be considered a moral imperative. However, before following this path, sound and reliable data on large samples and in a variety of contexts are required. Trial Registration: NCT02422914; (Archived by WebCite at

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    Same-Day Counseling: Study Protocol for the Evaluation of a New Mental Health Service


    Background: Single-session counseling is being implemented across Canada to increase the accessibility and availability of mental health services. Despite increasing use, existing research on single-session counseling is sparse and has methodological limitations. In addition, some stakeholders are skeptical that this model of care can support meaningful change for clients. Objective: The aim of this study is to evaluate a new single-session counseling program (called Same-Day Counseling) offered in an outpatient community mental health clinic in Northwestern Ontario, Canada. Methods: Clients who attend Same-Day Counseling services will be given the opportunity to participate in the program evaluation. Those who consent will complete measures before their session, after their session, and at 1-month follow-up. Data will provide information on who accesses Same-Day Counseling (eg, typical presenting problems, symptom severity), client satisfaction with services, and whether clients benefit from the services (eg, improved functioning and reduced symptom severity). Results: Data collection is underway with 80 participants having completed baseline measures and 55 participants having completed follow-up measures. Data collection is expected to conclude in December 2015. Conclusions: This study is designed to contribute to the literature regarding the integration of single-session counseling into ongoing mental health services, with additional attention to methodological rigour. Our approach will help to address ongoing concerns regarding the implementation of single-session counseling, and inform health care providers and policy makers regarding the utility of this model for addressing the mental health care need of the community.

  • A Multicenter Prospective Study to Investigate the Diagnostic Accuracy of the SeHCAT Test in Measuring Bile Acid Malabsorption: Research Protocol


    Background: Bile acid malabsorption (BAM) is one possible explanation for chronic diarrhea. BAM may be idiopathic, or result from ileal resection or inflammation including Crohn’s disease, or may be secondary to other conditions, including cholecystectomy, peptic ulcer surgery, and chronic pancreatitis. No “gold standard” exists for clinical diagnosis of BAM, but response to treatment with a bile acid sequestrant (BAS) is often accepted as confirmation. The SeHCAT (tauroselcholic [selenium-75] acid) test uses a radiolabeled synthetic bile acid and provides a diagnostic test for BAM, but its performance against “trial of treatment” is unknown. Fibroblast growth factor 19 (FGF-19) and 7-alpha-hydroxy-4-cholesten-3-one (C4) also offer potential new biomarkers of BAM. Objective: This protocol describes a multicenter prospective study to evaluate the diagnostic accuracy of SeHCAT and 2 biomarkers in predicting BAM as assessed by trial of treatment. Methods: Participating gastroenterology centers should have a minimum workload of 30 SeHCAT patients per annum. Patients should not be pregnant, on medication that could confound follow-up, or have any severe comorbidity. All eligible patients attending a gastrointestinal appointment will be invited to participate. On attending the SeHCAT test, blood and fecal samples will be collected for analysis of FGF-19 by enzyme-linked immunosorbent assay and for C4 and fractionated bile acids by liquid chromatography–mass spectrometry. A capsule containing radiolabeled SeHCAT will be administered orally and a scan performed to measure SeHCAT activity. Patients will return on day 7 to undergo a second scan to measure percentage SeHCAT retention. The test result will be concealed from clinicians and patients. BAS will be dispensed to all patients, with a follow-up gastroenterologist appointment at 2 weeks for clinical assessment of treatment response and adherence. Patients responding positively will continue treatment for a further 2 weeks and all patients will have a final follow-up at 8 weeks. The diagnostic accuracy of the SeHCAT test and biomarkers will be analyzed at different thresholds using sensitivity, specificity, positive and negative predictive value, likelihood ratios, and area under the curve in a sample of 600 patients. Multivariable logistic regression models will be used to assess the association between presence of BAM and continuous SeHCAT retention levels after adjustment for confounders. Results: Funding is being sought to conduct this research. Conclusions: The SeHCAT test for diagnosis of BAM has been in common use in the United Kingdom for more than 30 years and an evidence-based assessment of its accuracy is overdue. The proposed study has some challenges. Some forms of BAS treatment are unpleasant due to the texture and taste of the resin powder, which may negatively affect recruitment and treatment adherence. Trial of treatment is not as “golden” a standard as would be ideal, and itself warrants further study.

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    Assessing the Usability of Web-Based Alcohol Education for Older Adults: A Feasibility Study


    Background: Older adults can experience unfavorable health effects from drinking at relatively low consumption levels because of age-related physiological changes and alcohol’s potentially adverse interactions with declining health, increased medication-use and diminishing functional status. At the same time, alcohol use in older adults may be protective against heart disease, stroke, and other disorders associated with aging. We developed “A Toast to Health in Later Life! Wise Drinking as We Age,” a web-based educational intervention to teach older adults to balance drinking risks and benefits. Objective: To examine the intervention’s feasibility in a sample of community-dwelling current drinkers ≥55 years of age and examine its effects on their quantity and frequency of alcohol use, adherence to standard drinking guidelines, and alcohol-related risks. Methods: Participants were recruited in person, by mail and by telephone between September and October 2014 from a community-based social services organization serving Los Angeles County. Once enrolled, participants were randomly assigned to the intervention or to a control group. The conceptual frameworks for the intervention were the Health Belief Model, models of adult learning, and the US Department of Health and Human Services guidelines for designing easy-to-use websites. The intervention’s content focuses on the relationship between drinking and its effects on older adults’ medical conditions, use of medications, and ability to perform daily activities. It also addresses quantity and frequency of alcohol use, drinking and driving and binge drinking. The control group did not receive any special intervention. Data on alcohol use and risks for both groups came from the online version of the Alcohol-Related Problems Survey and were collected at baseline and four weeks later. Data on usability were collected online from the intervention group immediately after it completed its review of the website. Results: The 49 intervention and 47 control participants did not differ at baseline in age, ethnicity, medication use, medical conditions, or alcohol use and both groups were mostly female, college-educated, and in good health. Of the intervention participants, 94% (46/49) had little or no difficulty using the website, with 67% (33/49) reporting that they will change the way they think about drinking because of their exposure to the education. At the 4-week follow-up, the intervention group reported drinking less (P=.02). No changes between groups were found in quantity and frequency, adherence to recommended guidelines, or risk status. Conclusions: Community-dwelling older adults are receptive to online alcohol education. To be most effective, the education should be included as a component of a larger effort consisting of screening and counseling preferably in a health care setting.

  • Screenshot of tablet app.
(Image copyright: Study Authors).

    Developing a Tablet-Based Self-Persuasion Intervention Promoting Adolescent HPV Vaccination: Protocol for a Three-Stage Mixed-Methods Study


    Background: Human papillomavirus (HPV)-related cancers are a significant burden on the US health care system that can be prevented through adolescent HPV vaccination. Despite guidelines recommending vaccination, coverage among US adolescents is suboptimal particularly among underserved patients (uninsured, low income, racial, and ethnic minorities) seen in safety-net health care settings. Many parents are ambivalent about the vaccine and delay making a decision or talking with a provider about it. Self-persuasion—generating one’s own arguments for a health behavior—may be particularly effective for parents who are undecided or not motivated to make a vaccine decision. Objective: Through a 3-stage mixed-methods protocol, we will identify an optimal and feasible self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics. Methods: In Stage 1, we will define content for a tablet-based self-persuasion app by characterizing (1) parents’ self-generated arguments through cognitive interviews conducted with parents (n=50) of patients and (2) parent-provider HPV vaccine discussions through audio recordings of clinic visits (n=50). In Stage 2, we will compare the effects of the four self-persuasion intervention conditions that vary by cognitive processing level (parents verbalize vs listen to arguments) and choice of argument topics (parents choose vs are assigned topics) on parental vaccine intentions in a 2 × 2 factorial design randomized controlled trial (n=160). This proof-of-concept trial design will identify which intervention condition is optimal by quantitatively examining basic self-persuasion mechanisms (cognitive processing and choice) and qualitatively exploring parent experiences with intervention tasks. In Stage 3, we will conduct a pilot trial (n=90) in the safety-net clinics to assess feasibility of the optimal intervention condition identified in Stage 2. We will also assess its impact on parent-provider discussions. Results: This paper describes the study protocol and activities to date. Currently, we have developed the initial prototype of the tablet app for English- and Spanish-speaking populations, and completed Stage 1 data collection. Conclusions: Our systematic collaboration between basic and applied behavioral scientists accelerates translation of promising basic psychological research into innovative interventions suitable for underserved, safety-net populations. At project’s end, we plan to have a feasible and acceptable self-persuasion intervention that can affect key cancer disparities in the United States through prevention of HPV-related cancers. Trial Registration: and (Archived by WebCite at and, respectively).

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    Increasing Access to Mental Health Care With Breathe, an Internet-Based Program for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial


    Background: There is a demand to make first-line treatments, including cognitive behavioural therapy (CBT) for adolescent anxiety disorders, more widely available. Internet-based CBT is proposed to circumvent access and availability barriers and reduce health care system costs. Recent reviews suggest more evidence is needed to establish the treatment effects of Internet-based CBT in children and adolescents and to determine related economic impacts. Objective: This pilot trial aims to collect the necessary data to inform the planning of a full-scale RCT to test the effectiveness of the Internet-based CBT program Breathe (Being Real, Easing Anxiety: Tools Helping Electronically). Methods: We are conducting a 27-month, 2-arm parallel-group, pilot randomized controlled trial (RCT). Outcomes will inform the planning of a full-scale RCT aimed to test the effectiveness of Internet-based CBT with a population of adolescents with moderate to mild anxiety problems. In the pilot RCT we will: (1) define a minimal clinically important difference (MCID) for the primary outcome measure (total anxiety score using the Multidimensional Anxiety Scale for Children); (2) determine a sample size for the full-scale RCT; (3) estimate recruitment and retention rates; (4) measure intervention acceptability to inform critical intervention changes; (5) determine the use of co-interventions; and (6) conduct a cost-consequence analysis to inform a cost-effectiveness analysis in the full-scale RCT. Adolescents aged 13-17 years seeking care for an anxiety complaint from a participating emergency department, mobile or school-based crisis team, or primary care clinic are being screened for interest and eligibility. Enrolled adolescents are being randomly allocated to either 8 weeks of Internet-based CBT with limited telephone and e-mail support, or a control group with access to a static webpage listing anxiety resources. Adolescents are randomly assigned using a computer generated allocation sequence. Data are being collected at baseline, treatment completion, and at a 3-month follow-up. Results: Currently, adolescents are being enrolled in the study. Enrolment is taking place between March 2014 and February 2016; data collection will conclude May 2016. We expect that analysis and results will be available by August 2016. Conclusions: In many communities, the resources available for front-line anxiety treatment are outweighed by the need for care. This pilot RCT is an essential step to designing a robust RCT to evaluate the effectiveness of an Internet-based CBT program for adolescents with moderate to mild anxiety problems. Trial Registration: NCT02059226; (Archived by WebCite at

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    Patient Recruitment 2.0: Become a Partner in the Patient Journey Using Digital Media


    We describe a digital platform, Pioneering Healthcare, designed to inform and empower people who are impacted by lung cancer. The platform enables Roche to support an online conversation with patients and caregivers about lung cancer, and about the role of lung cancer clinical studies in the development of future treatment options. This conversation is live and ongoing on the platform. It provides insights about the views and motivations of patients, and about how to better support patients pursuing treatment for life-threatening illness. We discuss the strategies used to deploy Pioneering Healthcare, and the advantages of using digital platforms for raising disease awareness, increasing patient engagement and, ultimately, for boosting patient enrollment into clinical trials.

  • StepWise home page graphic.

    A Web-Based Intervention to Encourage Walking (StepWise): Pilot Randomized Controlled Trial


    Background: Despite Internet-based interventions that incorporate pedometers with appropriate goal-setting processes and other theoretically-based behavior change strategies being proposed as a means of increasing walking behavior, few have incorporated all of these key features or assessed maintenance of behavior change. Objective: The objective of our study was to investigate the effect of a 12-week pedometer step goal walking program individually tailored to baseline step counts, combined with an interactive support website for step counts, health parameters and motivation over 12 and 24 weeks. Methods: Low active participants (mean [SD] 46.2 [11.2] years) were randomly assigned to the Stepwise (SW) intervention group (n=49) or a comparison (CP) group (n=48). SW received a pedometer, step goal walking program and access to the SW website (containing interactive self-monitoring and goal feedback tools, motivational messages and action and coping planning strategies). CP received a pedometer and locally available physical activity information. Step counts, BMI, resting heart rate, blood pressure and glucose, cholesterol and triglyceride levels, psychological well-being, perceived health, self-efficacy and self-determined motivation were measured at baseline, 12 and 24 weeks. Results: Linear mixed model analysis found that both groups’ step counts increased from baseline to week 12 (β = 11,002, CI 5739-16,266, P<.001) and 24 (β = 6810, CI 1190-12,431; P=.02). Group step counts were significantly different at week 24 with SW taking 8939 (CI 274-17604, P=.04) more steps compared to CP. Compared to baseline, both groups had improved triglyceride levels (0.14 mmol/L, CI -0.25 to -0.02, P=.02) at week 12, decreased diastolic blood pressure (4.22 mmHg, CI -6.73 to -1.72) at weeks 12 and 24 (3.17 mmHg, CI -5.55 to -0.78), improved positive (β = .21, CI 0.03-0.38, P=.02) and negative affect (β = -.15, CI -0.28 to -0.03, P=.02) at week 12, and perceived health at week 12 (β = 6.37, CI 2.10-10.65, P=.004) and 24 (β = 8.52, CI 3.98-13.06, P<.001). Total cholesterol increased at week 12 (0.26 mmol/L, CI 0.099-0.423, P=.006) and week 24 (0.38 mmol/L, CI 0.20-0.56, P<.001). Repeated measures ANOVA found motivation for walking improved from baseline with higher task self-efficacy (P<.001, η2 = .13) and autonomous motivation (P<.001, η2=.14) at weeks 12 and 24 and decreased controlled motivation (P=.004, η2=.08) at week 24. Conclusions: Both groups had similar improvements in step counts and physical and psychological health after 12 weeks but only the SW group successfully maintained the increased step-counts 24 weeks post-intervention. This suggests the step-goal based walking program combined with Internet-based behavior change tools were important for sustained behavior change.

  • Computerized Tailored Interventions to Enhance Prevention and Screening for Hepatitis C Virus Among People Who Inject Drugs: Protocol for a Randomized Pilot...


    Background: Hepatitis C virus (HCV) infection is a growing problem among people who inject drugs. Strategies to reduce disease transmission (eg, syringe exchange programs) and facilitate HCV screening and linkage are available but are under-utilized in many communities affected by injection drug use. Novel approaches to increasing the use of these strategies are needed. Objective: The goals of this project are to (1) develop and pilot test a computerized tailored intervention for increasing HCV screening and decreasing risky drug use behavior among people who inject drugs and (2) determine the feasibility of disseminating such an intervention using peer-based referrals in the setting of a community-based syringe exchange program. Methods: This 2-arm, randomized pilot study is being conducted in a large-volume, multisite syringe exchange program in southern Wisconsin. A social network–based strategy was used to recruit a total of 235 adults who reported past-month injection of opioids, cocaine, or methamphetamine. Network recruiters were identified among clients requesting services from the syringe exchange program and were enlisted to refer eligible peers to the study. All participants completed a computer-adapted questionnaire eliciting information about risk behaviors and their knowledge, attitudes, and prior experiences related to HCV screening. Subjects were then randomly assigned to receive usual care, consisting of standard counseling by syringe exchange staff, or the Hep-Net intervention, which provides algorithm-based, real-time tailored feedback and recommendations for behavior change in the style of motivational interviewing. Changes in drug use behaviors and attitudes will be assessed during a second session between 90 and 180 days after the baseline visit. Frequency of repeat HCV testing and HCV incidence will be assessed through a database search 1 year after study completion. Results: Recruitment for this study was completed in April 2015. Follow-up of enrolled participants is expected to continue until March 2016. Network recruiters were enrolled who referred a total of 195 eligible peers (overall N=235). At baseline, the median age was 34 years; 41.3% (97/235) were non-white; and 86.4% (203/235) reported predominantly injecting heroin. Most participants (161/234, 68.8%) reported sharing injection equipment in the past and of these, 30.4% (49/161) had never been tested for HCV. Conclusions: This study will provide preliminary evidence to determine whether incorporating computerized behavioral interventions into existing prevention services at syringe exchange programs can lead to adoption of healthier behaviors. Trial Registration: NCT02474043; (Archived by WebCite at

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    HEART Pathway Accelerated Diagnostic Protocol Implementation: Prospective Pre-Post Interrupted Time Series Design and Methods


    Background: Most patients presenting to US Emergency Departments (ED) with chest pain are hospitalized for comprehensive testing. These evaluations cost the US health system >$10 billion annually, but have a diagnostic yield for acute coronary syndrome (ACS) of <10%. The history/ECG/age/risk factors/troponin (HEART) Pathway is an accelerated diagnostic protocol (ADP), designed to improve care for patients with acute chest pain by identifying patients for early ED discharge. Prior efficacy studies demonstrate that the HEART Pathway safely reduces cardiac testing, while maintaining an acceptably low adverse event rate. Objective: The purpose of this study is to determine the effectiveness of HEART Pathway ADP implementation within a health system. Methods: This controlled before-after study will accrue adult patients with acute chest pain, but without ST-segment elevation myocardial infarction on electrocardiogram for two years and is expected to include approximately 10,000 patients. Outcomes measures include hospitalization rate, objective cardiac testing rates (stress testing and angiography), length of stay, and rates of recurrent cardiac care for participants. Results: In pilot data, the HEART Pathway decreased hospitalizations by 21%, decreased hospital length (median of 12 hour reduction), without increasing adverse events or recurrent care. At the writing of this paper, data has been collected on >5000 patient encounters. The HEART Pathway has been fully integrated into health system electronic medical records, providing real-time decision support to our providers. Conclusions: We hypothesize that the HEART Pathway will safely reduce healthcare utilization. This study could provide a model for delivering high-value care to the 8-10 million US ED patients with acute chest pain each year. ClinicalTrial: NCT02056964; (Archived by WebCite at

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  • Novel use of hydroxyurea in an African region with malaria: protocol for a randomized controlled clinical trial

    Date Submitted: Feb 3, 2016

    Open Peer Review Period: Feb 6, 2016 - Feb 20, 2016

    substitution on the beta globin protein of hemoglobin, which leads to hemolytic anemia.) Early mortality is likely to be significantly reduced with the development and implementation of interventions...

    substitution on the beta globin protein of hemoglobin, which leads to hemolytic anemia.) Early mortality is likely to be significantly reduced with the development and implementation of interventions such as comprehensive newborn screening programs, however, these interventions will not treat or cure the underlying disease. Hydroxyurea is the only disease-modifying therapy approved by the Food and Drug Administration for SCA, and its use as a once daily oral medication for SCA patients in sub-Saharan Africa is an ideal option. New NHLBI evidence-based guidelines include strong recommendations for more widespread use of hydroxyurea in both children and adults with SCA. However, the risk of malaria and hematologic toxicities from hydroxyurea in children with SCA living in malaria endemic areas is unknown, and there is currently equipoise about the safety of hydroxyurea in a malaria endemic region. Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM, NCT01976416) is a prospective, randomized, placebo-controlled, double-blinded phase III trial to compare risk of malaria with oral hydroxyurea vs. placebo among 200 Ugandan children between 1.00 and 3.99 years of age with confirmed sickle cell anemia. Children will be recruited from the Mulago Hospital Sickle Cell Clinic in Kampala, Uganda and randomized into treatment groups by order of entry in the study, based on a pre-determined blinded randomization list. Study objectives include determining the incidence of malaria in sickle cell anemia patients taking hydroxyurea versus placebo; establishing the frequency of hematologic toxicities and adverse events in children with sickle cell anemia treated with hydroxyurea versus placebo, and defining the relationships between hydroxyurea treatment and fetal hemoglobin, soluble ICAM-1, and nitric oxide levels, and between levels of these factors and risk of subsequent malaria. The primary outcome of the trial is malaria incidence in the two study groups, defined as episodes of clinical malaria occurring over the one-year randomized study treatment period. NOHARM will be the first prospective randomized, placebo-controlled clinical trial investigating the use of hydroxyurea for children with SCA in a malaria endemic region within Africa. The results of this trial have the potential to significantly advance understanding of how to safely and effectively use hydroxyurea in children with SCA in malaria endemic areas.

  • Attitudes to and Understanding of Risk of Acquisition of HIV over Time: The AURAH2 Study. Design and Methods for an internet-based prospective cohort study among UK men who have sex with men.

    Date Submitted: Jan 29, 2016

    Open Peer Review Period: Jan 30, 2016 - Feb 13, 2016

    Background: The annual number of new HIV infections among men who have sex with men (MSM) has risen in the UK and, of those HIV positive, the proportion undiagnosed is high. The prospective AURAH2 stu...

    Background: The annual number of new HIV infections among men who have sex with men (MSM) has risen in the UK and, of those HIV positive, the proportion undiagnosed is high. The prospective AURAH2 study aims to assess factors associated with HIV acquisition among MSM in the UK, and to investigate changes over time within individuals in sexual behaviour and HIV-testing practices. Methods/Design: AURAH2 is a prospective study among MSM without diagnosed HIV, aiming to recruit up to 1000 sexually active MSM attending sexual health clinics in London and Brighton. Participants complete an initial paper-based questionnaire, followed by four monthly online follow-up questionnaires collecting socio-demographic, health and behavioural data, including sexual behaviour, recreational and other drug use, HIV testing practices and Pre-Exposure Prophylaxis use, over a planned three year period. Discussion: The results from AURAH2 study will provide an important insight into established and emerging risk behaviours that may be associated with acquisition of HIV in MSM, in the UK, changes over time within individuals in sexual behaviour, and inform on HIV testing practices. This data will be crucial to inform future HIV prevention strategies.

  • Risk Factors for Low Back Disorders in Saskatchewan Farmers: Building a Foundation for Epidemiological Studies

    Date Submitted: Jan 27, 2016

    Open Peer Review Period: Jan 28, 2016 - Feb 11, 2016

    Studies of many geographical settings and agricultural commodities show that low back disorders are an important public health issue among farmers, who represent a special rural population. However,...

    Studies of many geographical settings and agricultural commodities show that low back disorders are an important public health issue among farmers, who represent a special rural population. However, few studies have examined the impact of low back disorders among farmers’ work or the strategies that they develop to avoid associated pain and disability. This study protocol is will investigate 3 issues related to low back disorders in Saskatchewan farmers: 1) the vibration, heavy lifting, and awkward postures farmers encounter during their work that might contribute to low back disorders; 2) the impact low back disorders have on farmers in terms of pain and disability; 3) the types of preventative measures and solutions that farmers implement to reduce the occurrence low back pain. To answer these questions, researchers will travel to 30 farms to make measurements of vibration, lifting and posture during the farmers’ regular work tasks. Farmers will be interviewed about any pain and/or disability using standardized interview questions. Farmers will also be asked about safety measures they have implemented at their farm, such as modified tools or equipment, to reduce the occurrence low back disorders or pain. Occupational determinants of health such as vibration, heavy lifting, and awkward postures are important in the development and progression of low-back disorders, and the results of this study will allow for cost-effective epidemiological studies of these determinants in the future. In identifying prevention strategies, this study will also facilitate future research evaluating the effectiveness of safety measures.

  • A study protocol to examine working time arrangements as potential risk factors for ischaemic heart disease among workers in Denmark

    Date Submitted: Jan 25, 2016

    Open Peer Review Period: Jan 28, 2016 - Feb 11, 2016

    Background: It has long been suspected that a worker’s risk of developing an ischaemic heart disease (IHD) may be influenced by his working time arrangements. A multitude of studies have been perfor...

    Background: It has long been suspected that a worker’s risk of developing an ischaemic heart disease (IHD) may be influenced by his working time arrangements. A multitude of studies have been performed and a special attention has been given to long working hours and night time work, respectively. The statistical powers of the individual studies have, however, generally been too low to either dismiss or confirm an actual relationship and Meta-analyses of underpowered studies are generally associated with publication bias. Hence, uncertainty remains and it has yet to be settled whether or not these factors indeed are related to IHD. Objective: The presented project will test if the incidence of IHD among employees in Denmark is independent of weekly working hours and night time work, respectively. We will here present the intended analysis. Methods: Individual participant data from the Danish labour force survey, 1999 – 2013, will be linked to data on socio-economic status, industry, emigrations, redeemed prescriptions, hospitalisations and deaths, from registers which cover the entire population of Denmark. The study will include approximately 160 000 participants who will be followed through the registers, from the time of the interview until the end of 2014, for first occurrence of IHD and antihypertensive drug treatment, respectively. Poisson regression will be used to analyse incidence rates as a function of night time work and weekly working hours, respectively. Results: Results are expected to be ready in mid-2017. Conclusions: This will be the largest study ever of its kind. It will, moreover, be free from hindsight bias since the hypotheses, inclusion criteria, significance levels and statistical models will be completely defined and published before we are allowed to link the exposure data to the outcome data.

  • A prospective multicenter observational quality study of single-incision multiport / single port laparoscopic abdominal surgery (SILAP study)

    Date Submitted: Jan 24, 2016

    Open Peer Review Period: Jan 28, 2016 - Feb 11, 2016

    Background: Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency towards reducing the number of abdominal skin incisions. Retrospecti...

    Background: Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency towards reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However large prospective multicenter observational datasets do not currently exist. Objective: This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance and the patients’ perspective. Accordingly, the SILAP study will supplement the existing evidence, which is currently too sparse to allow evidence-based surgical decision-making. Methods: The single-incision multiport / single port laparoscopic abdominal surgery study (SILAP study) is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patients characteristics and technical aspects will be monitored. We expect more than 100 surgical centers to participate and 5000 patients with abdominal single-incision surgery during the study period. Results: Funding was obtained on 2012; enrollment began on January 01, 2013 and will be completed on December 31, 2018. At the moment (January 2016) are 2119 patients included. 106 German Centers are registered and 27 centers are very active (>5 patients per year). Conclusions: This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful. Clinical Trial: German Clinical Trials Register: DRKS00004594