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:

  • Example of description of a service displayed in the servi-Share Web-app.

    Co-creating and Evaluating a Web-app Mapping Real-World Health Care Services for Students: The servi-Share Protocol

    Abstract:

    Background: University students aged 18-30 years are a population group reporting low access to health care services, with high rates of avoidance and delay of medical care. This group also reports not having appropriate information about available health care services. However, university students are at risk for several health problems, and regular medical consultations are recommended in this period of life. New digital devices are popular among the young, and Web-apps can be used to facilitate easy access to information regarding health care services. A small number of electronic health (eHealth) tools have been developed with the purpose of displaying real-world health care services, and little is known about how such eHealth tools can improve access to care. Objective: This paper describes the processes of co-creating and evaluating the beta version of a Web-app aimed at mapping and describing free or low-cost real-world health care services available in the Bordeaux area of France, which is specifically targeted to university students. Methods: The co-creation process involves: (1) exploring the needs of students to know and access real-world health care services; (2) identifying the real-world health care services of interest for students; and (3) deciding on a user interface, and developing the beta version of the Web-app. Finally, the evaluation process involves: (1) testing the beta version of the Web-app with the target audience (university students aged 18-30 years); (2) collecting their feedback via a satisfaction survey; and (3) planning a long-term evaluation. Results: The co-creation process of the beta version of the Web-app was completed in August 2016 and is described in this paper. The evaluation process started on September 7, 2016. The project was completed in December 2016 and implementation of the Web-app is ongoing. Conclusions: Web-apps are an innovative way to increase the health literacy of young people in terms of delivery of and access to health care. The creation of Web-apps benefits from the involvement of stakeholders (eg, students and health care providers) to correctly identify the real-world health care services to be displayed.

  • A. The NanoKnife IRE console. B. The console operates with 19G monopolar needle electrodes, which are bundled together using the external spacers.

    Irreversible Electroporation for the Ablation of Renal Cell Carcinoma: A Prospective, Human, In Vivo Study Protocol (IDEAL Phase 2b)

    Abstract:

    Background: Irreversible electroporation (IRE) is an emerging technique delivering electrical pulses to ablate tissue, with the theoretical advantage to overcome the main shortcomings of conventional thermal ablation. Recent short-term research showed that IRE for the ablation of renal masses is a safe and feasible treatment option. In an ablate and resect design, histopathological analysis 4 weeks after radical nephrectomy demonstrated that IRE-targeted renal tumors were completely covered by ablation zone. In order to develop a validated long-term IRE follow-up study, it is essential to obtain clinical confirmation of the efficacy of this novel technology. Additionally, follow-up after IRE ablation obliges verification of a suitable imaging modality. Objective: The objectives of this study are the clinical efficacy and safety of IRE ablation of renal masses and to evaluate the use of cross-sectional imaging modalities in the follow-up after IRE in renal tumors. This study conforms to the recommendations of the IDEAL Collaboration and can be categorized as a phase 2B exploration trial. Methods: In this prospective clinical trial, IRE will be performed in 20 patients aged 18 years and older presenting with a solid enhancing small renal mass (SRM) (≤4 cm) who are candidates for ablation. Magnetic resonance imaging (MRI) and contrast-enhanced ultrasound (CEUS) will be performed at 1 day pre-IRE, and 1 week post-IRE. Computed tomography (CT), CEUS, and MRI will be performed at 3 months, 6 months, and 12 months post-IRE. Results: Presently, recruitment of patients has started and the first inclusions are completed. Preliminary results and outcomes are expected in 2018. Conclusions: To establish the position of IRE ablation for treating renal tumors, a structured stepwise assessment in clinical practice is required. This study will offer fundamental knowledge on the clinical efficacy of IRE ablation for SRMs, potentially positioning IRE as ablative modality for renal tumors and accrediting future research with long-term follow-up. Trial Registration: Clinicaltrials.gov registration number NCT02828709; https://clinicaltrials.gov/ct2/show/NCT02828709 (archived by WebCite at http://www.webcitation.org/6nmWK7Uu9). Dutch Central Committee on Research Involving Human Subjects NL56935.018.16

  • IPD Prospective Meta-analysis VESPRO Collaboration.

    VESPRO: An Individual Patient Data Prospective Meta-Analysis of Selective Internal Radiation Therapy Versus Sorafenib for Advanced, Locally Advanced, or...

    Abstract:

    Background: Untreated advanced hepatocellular carcinoma (HCC) has an overall poor prognosis. Currently there are 2 ongoing prospective randomized controlled trials that are evaluating the efficacy and safety of sorafenib and selective internal radiation therapy (SIRT) with yttrium-90 resin microspheres in patients with advanced HCC. The SorAfenib versus Radioembolisation in Advanced Hepatocellular carcinoma (SARAH; 459 patients) trial is being performed in Europe and the SIRt VErsus SorafeNIB (SIRveNIB; 360 patients) trial in the Asia Pacific region. Prospectively combining the results, these trials will not only allow for increased precision to estimate efficacy (in terms of survival), but will also provide increased statistical power for subgroup analyses. Objective: To ensure the prospectivity and transparency of the meta-analysis. Methods: The sirVEnib and SARAH merge PROject (VESPRO) is an individual, patient-data prospective meta-analysis of the SIRveNIB and SARAH randomized trials. The VESPRO protocol includes prespecified hypotheses, inclusion criteria, and outcome measures. The primary outcome measure is overall survival and secondary outcomes include tumor response rate, progression-free survival, progression in the liver as first event, and disease control in the liver. Pooling of toxicity results will allow for robust safety profiles to be established for both therapies, and provides increased statistical power to investigate treatment effects in key subgroups. Analyses will be performed in the intent-to-treat population stratified by trial. Results: Both studies are expected to demonstrate a survival benefit for SIRT together with a better toxicity profile compared with sorafenib. It is also anticipated that liver progression as the first event would be longer in the intervention compared with the control. Conclusions: As the results of the 2 trials are not yet known, the methodological strength is enhanced, as biases inherent in conventional meta-analyses are avoided. This has the effect of providing this meta-analysis with the advantages of a single, large,randomized study of 819 patients. It is anticipated that the SARAH and SIRveNIB trial results will be published separately and together with the combined meta-analysis results from VESPRO. The combined dataset will allow the effect of the interventions to be explored with improved reliability/precision with respect to prespecified patient and intervention-level characteristics. Trial Registration: Australian New Zealand Trials Registry: ACTRN12617000030370.

  • Vascular View. Image sourced and copyright owned by authors.

    Self-Management Support Program for Patients With Cardiovascular Diseases: User-Centered Development of the Tailored, Web-Based Program Vascular View

    Abstract:

    Background: In addition to medical intervention and counseling, patients with cardiovascular disease (CVD) need to manage their disease and its consequences by themselves in daily life. Objective: The aim of this paper is to describe the development of “Vascular View,” a comprehensive, multi-component, tailored, Web-based, self-management support program for patients with CVD, and how this program will be tested in an early randomized controlled trial (RCT). Methods: The Vascular View program was systematically developed in collaboration with an expert group of 6 patients, and separately with a group of 6 health professionals (medical, nursing, and allied health care professionals), according to the following steps of the intervention mapping (IM) framework: (1) conducting a needs assessment; (2) creating matrices of change objectives; (3) selecting theory-based intervention methods and practical applications; (4) organizing methods and applications into an intervention program; (5) planning the adaption, implementation, and sustainability of the program, and (6) generating an evaluation plan. Results: The needs assessment (Step 1) identified 9 general health problems and 8 determinants (knowledge, awareness, attitude, self-efficacy, subjective norm, intention, risk perception, and habits) of self-managing CVD. By defining performance and change objectives (Step 2), 6 topics were distinguished and incorporated into the courses included in Vascular View (Steps 3 and 4): (1) Coping With CVD and its Consequences; (2) Setting Boundaries in Daily Life; (3) Lifestyle (general and tobacco and harmful alcohol use); (4) Healthy Nutrition; (5) Being Physically Active in a Healthy Way; and (6) Interaction With Health Professionals. These courses were based on behavioral change techniques (BCTs) (eg, self-monitoring of behavior, modeling, re-evaluation of outcomes), which were incorporated in the courses through general written information: quotes from and videos of patients with CVD as role models and personalized feedback, diaries, and exercises. The adoption and implementation plan (Step 5) was set up in collaboration with the members of the two expert groups and consisted of a written and digital instruction manual, a flyer, bimonthly newsletters, and reminders by email and telephone to (re-)visit the program. The potential effectiveness of Vascular View will be evaluated (Step 6) in an early RCT to gain insight into relevant outcome variables and related effect sizes, and a process evaluation to identify intervention fidelity, potential working mechanisms, user statistics, and/or satisfaction. Conclusion: A comprehensive, multi-component, tailored, Web-based, self-management support program and an early RCT were developed in order to empower patients to self-manage their CVD. Trial Registration: Nederlands Trial Register NTR5412; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5412 (Archived by WebCite at http://www.webcitation.org/6jeUFVj40)

  • Woman working in hospital. Photo credit: Stanford EdTech. Image source: Flickr http://www.flickr.com/photos/21507031@N04/5276108440 licensed under Creative Commons BY-NC-ND 2.0.

    Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial

    Abstract:

    Background: Conscious sedation is regularly used in ambulatory surgery to improve patient outcomes, in particular patient satisfaction. Reports suggest that the addition of conscious sedation to local anesthesia for inguinal hernioplasty is safe and effective in improving patient satisfaction. No previous randomized controlled trial has assessed the benefit of conscious sedation in this regard. Objective: To determine whether the addition of conscious sedation to local anesthesia improves patient satisfaction with inguinal hernioplasty. Methods: This trial is designed as a single-center, randomized, placebo-controlled, blinded trial of 148 patients. Adult patients diagnosed with a reducible, unilateral inguinal hernia eligible for hernioplasty using local anesthesia will be recruited. The intervention will be the use of intravenous midazolam for conscious sedation. Normal saline will be used as placebo in the control group. The primary outcome will be patient satisfaction, measured using the validated Iowa Satisfaction with Anesthesia Scale. Secondary outcomes will include intra- and postoperative pain, operative time, volumes of sedative agent and local anesthetic used, time to discharge, early and late complications, and postoperative functional status. Results: To date, 171 patients have been recruited. Surgery has been performed on 149 patients, meeting the sample size requirements. Follow-up assessments are still ongoing. Trial completion is expected in August 2017. Conclusions: This randomized controlled trial is the first to assess the effectiveness of conscious sedation in improving patient satisfaction with inguinal hernioplasty using local anesthesia. If the results demonstrate improved patient satisfaction with conscious sedation, this would support routine incorporation of conscious sedation in local inguinal hernioplasty and potentially influence national and international hernia surgery guidelines. Trial registration: Clinicaltrials.gov NCT02444260; https://clinicaltrials.gov/ct2/show/NCT02444260 (Archived by WebCite at http://www.webcitation.org/6no8Dprp4)

  • Involving Children With Cancer in Health Promotive Research. Image Source: the authors. Image is owned by the authors.

    Involving Children With Cancer in Health Promotive Research: A Case Study Describing Why, What, and How

    Abstract:

    Background: Participatory research approaches have been introduced to meet end-users’ needs in the development of health promotion interventions among children. However, whereas children are increasingly involved as passive informants in particular parts of research, they are rarely involved as partners, equal to adult researchers, throughout the research process. This is especially prominent in the context of child health where the child is commonly considered to be vulnerable or when the research concerns sensitive situations. In these cases, researchers and gatekeepers to children’s involvement base their resistance to active involvement of children on potential adverse effects on the accuracy or quality of the research or on ethical or moral principles that participation might harm the child. Thus most research aimed at developing health promotion interventions for children in health care is primarily based on the involvement of parents, caregivers, and other stakeholders. Objective: The objective of this paper is to discuss reasons for involving children in health promotive research and to explore models for children’s participation in research as a basis for describing how researchers can use design methodology and participatory approaches to support the participation and contribution of children in a vulnerable context. Methods: We developed and applied a model for children's participation in research to the development of a digital peer support service for children cancer survivors. This guided the selection of appropriate research and design methodologies (such as interviews, focus groups, design sessions, and usability evaluation) for involving the children cancer survivors (8-12 years) in the design of a digital peer support service. Results: We present a model for what children’s participation in research means and describe how we practically implemented this model in a research project on children with cancer. This paper can inform researchers in their planning of strategies for children’s participation and ensure future development of health promotion interventions for children is based on their perspectives. Conclusions: Challenges in reaching a suitable degree of participation during a research project involve both creating opportunities for children to have genuine influence on the research process and organizing this involvement so that they feel they understand what they are involved in and why. To achieve this, it is essential to enable children to be involved in research over time to gain confidence in the researchers and to develop children’s abilities to make decisions throughout the research processes.

  • Healthy older adult. Image source: https://www.pexels.com/photo/man-hands-waiting-senior-33786/. Copyright: CC0 License.

    Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults

    Abstract:

    Background: Increased oxidative stress and inflammation are associated with aging, and contribute to an increased risk of chronic disease in older adults. Flaxseed lignans demonstrate antioxidant and anti-inflammatory activity, but their ability to reduce oxidative stress and inflammation markers in older adult populations has received limited investigation. Objective: This is a chronic intervention trial of community-dwelling healthy older adults to examine the effects of a flaxseed lignan (secoisolariciresinol diglucoside; SDG) enriched supplement (BeneFlax) compared to a placebo. The primary aim was to demonstrate the safety of BeneFlax and confirm its anti-inflammatory efficacy on markers of oxidative stress and inflammation, and subsequent functional outcomes, including those associated with its anti-inflammatory efficacy. A secondary aim was to determine flaxseed lignan metabolite concentrations in blood. Methods: A double-blind randomized clinical trial was conducted. Subjects were healthy community-dwelling adults aged 60-80 years. Testing was performed at baseline, 8, 16, and 24 weeks. The 24-week intervention consisted of 600 milligrams (mg) of SDG daily or an equivalent amount (volume) of placebo. All participants received 1000 international units of vitamin D to ensure adequate vitamin D status. Measurements consisted of blood pressure, hematology, and tolerability for safety assessments; blood oxidative stress and inflammatory biomarkers for efficacy; and cognition, muscle strength, and pain as functional outcomes. Secondary endpoints of plasma levels of lignan metabolites were analyzed by mass spectrometry. Other tests, such as bone turnover markers and fecal levels of flax cyclolinopeptides, will be performed at a later date. Results: Thirty-two participants were recruited (19 intervention and 13 control) and all completed the trial. Numerous Health Canada-imposed exclusion criteria limited recruitment success. Analyses are ongoing, but the baseline data available for a number of parameters indicate no differences between treatment groups. Safety measures (vital signs) did not change from baseline and were not significantly different between treatment and placebo groups at 24 weeks. Conclusions: Preliminary results indicate that no safety concerns are associated with administering 600 mg SDG for 24 weeks to adults between the ages of 60 and 80 years. Trial Registration: Clinicaltrials.gov NCT01846117; https://clinicaltrials.gov/ct2/show/NCT01846117 (Archived by WebCite at http://www.webcitation.org/6nlDZNjmA)

  • SNAP II device. Image sourced and copyright owned by authors.

    A Prospective, Multicenter, Single-Blind Study Assessing Indices of SNAP II Versus BIS VISTA on Surgical Patients Undergoing General Anesthesia

    Abstract:

    Background: Traditionally, anesthesiologists have relied on nonspecific subjective and objective physical signs to assess patients’ comfort level and depth of anesthesia. Commercial development of electrical monitors, which use low- and high-frequency electroencephalogram (EEG) signals, have been developed to enhance the assessment of patients’ level of consciousness. Multiple studies have shown that monitoring patients’ consciousness levels can help in reducing drug consumption, anesthesia-related adverse events, and recovery time. This clinical study will provide information by simultaneously comparing the performance of the SNAP II (a single-channel EEG device) and the bispectral index (BIS) VISTA (a dual-channel EEG device) by assessing their efficacy in monitoring different anesthetic states in patients undergoing general anesthesia. Objective: The primary objective of this study is to establish the range of index values for the SNAP II corresponding to each anesthetic state (preinduction, loss of response, maintenance, first purposeful response, and extubation). The secondary objectives will assess the range of index values for BIS VISTA corresponding to each anesthetic state compared to published BIS VISTA range information, and estimate the area under the curve, sensitivity, and specificity for both devices. Methods: This is a multicenter, prospective, double-arm, parallel assignment, single-blind study involving patients undergoing elective surgery that requires general anesthesia. The study will include 40 patients and will be conducted at the following sites: The Ohio State University Medical Center (Columbus, OH); Northwestern University Prentice Women's Hospital (Chicago, IL); and University of Miami Jackson Memorial Hospital (Miami, FL). The study will assess the predictive value of SNAP II versus BIS VISTA indices at various anesthetic states in patients undergoing general anesthesia (preinduction, loss of response, maintenance, first purposeful response, and extubation). The SNAP II and BIS VISTA electrode arrays will be placed on the patient’s forehead on opposite sides. The hemisphere location for both devices’ electrodes will be equally alternated among the patient population. The index values for both devices will be recorded and correlated with the scorings received by performing the Modified Observer’s Assessment of Alertness and Sedation and the American Society of Anesthesiologists Continuum of Depth of Sedation, at different stages of anesthesia. Results: Enrollment for this study has been completed and statistical data analyses are currently underway. Conclusions: The results of this trial will provide information that will simultaneously compare the performance of SNAP II and BIS VISTA devices, with regards to monitoring different anesthesia states among patients. ClinicalTrial: Clinicaltrials.gov NCT00829803; https://clinicaltrials.gov/ct2/show/NCT00829803 (Archived by WebCite at http://www.webcitation.org/6nmyi8YKO)

  • Text communication and substance use among young adult African American gay and bisexual men. Image source: http://www.istockphoto.com/photo/african-american-man-hand-holding-mobile-phone-gm484716762-71425531. Copyright: m-imagephotography. Image purchased by authors.

    Feasibility of Ecological Momentary Assessment of Daily Sexting and Substance Use Among Young Adult African American Gay and Bisexual Men: A Pilot Study

    Abstract:

    Background: Recent evidence suggests that sexualized text communication (“sexting”) is associated with substance use and sexual risk behaviors among young adults, yet little is known about this relationship among young adult African American gay and bisexual men, a population disproportionately impacted by HIV in the United States. Rapid advances in mobile phone technology indicate a clear need for research using mobile health (mHealth) methods such as ecological momentary assessment (EMA) to serve as a viable counterpart to retrospective evaluation methods by using real-time data collection to assess sexting and substance use among this population. Objective: The objective of this pilot study was to (1) describe the EMA study design and protocol, (2) characterize the study population, and (3) assess the feasibility of a random prompt text message-based thrice-daily EMA over 14 days, as a means of prospectively studying sexting, marijuana, and alcohol use among a sample of young adult African American gay and bisexual men ages 21 to 25. Methods: Participants were recruited through flyers and snowball sampling during spring and summer 2015 at a community-based HIV/AIDS prevention, care, and support organization in Washington, DC. Eligible participants were enrolled in a one-time in-person study visit that consisted of informed written consent to participate in the study, a self-administered survey, a semi-structured interview, and enrollment and training in EMA data collection. Commencing the day after the study visit, a random prompt survey was texted to participants on their personal mobile phones 3 times a day over a 14-day data collection period assessing mood, texts sent, texts received, sexts sent, sexts received, marijuana want, marijuana use, and alcohol use. Results: EMA feasibility was tested with 25 self-identified African American gay (n=16) and bisexual (n=9) men (mean age of 23.48 years, SD 1.5). Each random prompt survey had 8 questions with responses including yes/no and Likert scale options. There were 104 total days of EMA observation, and the retention rate was 72% (18 out of 25 participants). Participants responded to the random prompt surveys with a 57.3% compliance rate providing a total of 544 completed surveys out of 949 surveys. The overall mean response time to complete a survey was 6.1 minutes. There were significant positive associations between EMA texts sent and received questions (ρ 0.84, P<.001) as well as sexts sent and received queries (ρ 0.72, P<.001). Conclusions: The use of an EMA protocol has the potential to be a very useful research tool for understanding episodic behaviors such as sexting and substance use in this relatively understudied and underserved population, and has implications for practice. Additional research is needed on how to maximize survey compliance.

  • Photoaged image showing the consequences of smoking 1 pack a day for 1 year. Image sourced and copyright owned by authors.

    A Medical Student–Delivered Smoking Prevention Program, Education Against Tobacco, for Secondary Schools in Brazil: Study Protocol for a Randomized Trial

    Abstract:

    Background: Smoking is the largest preventable cause of morbidity and mortality in Brazil. Education Against Tobacco (EAT) is a large network of medical students in 13 countries who volunteer for school-based prevention in the classroom setting. A recent quasi-experimental EAT study conducted in Germany showed significant short-term smoking cessation effects on 11- to 15-year-old adolescents. Objective: The aim of this study is both to describe and to provide the first randomized long-term evaluation of the EAT intervention involving a photoaging app for its effectiveness to reduce the smoking prevalence among 12- to 17-year-old pupils in Brazilian public schools. Methods: A randomized controlled trial will be conducted among approximately 1500 adolescents aged 12 to 17 years in grades 7-11 of public secondary schools in Brazil. The prospective experimental study design includes measurements at baseline and at 6 and 12 months postintervention. The study groups will consist of randomized classes receiving the standardized EAT intervention (90 minutes of mentoring in a classroom setting) and control classes within the same schools (no intervention). The questionnaire measures smoking status, gender, social, and cultural aspects as well as predictors of smoking. Biochemical validation of smoking status is conducted via random carbon monoxide measurements. The primary end point is the difference of the change in smoking prevalence in the intervention group versus the difference in the control group at 12 months of follow-up. The differences in smoking behavior (smoking onset, quitting) between the 2 groups as well as effects on the different genders will be studied as secondary outcomes. Results: The recruitment of schools, participating adolescents, and medical students was conducted from August 2016 until January 2017. The planned period of data collection is February 2017 until June 2018. Data analysis will follow in July 2018 and data presentation/publication will follow shortly thereafter. Conclusions: This is the first evaluative study of a medical student–delivered tobacco prevention program in Brazil and the first randomized trial on the long-term effectiveness of a school-based medical student–delivered tobacco prevention program in general. ClinicalTrial: ClinicalTrials.gov NCT02725021; https://clinicaltrials.gov/ct2/show/NCT02725021 (archived by WebCite at http://www.webcitation.org/6njy3nNml)

  • Be-PrEP-ared logo. Image sourced and copyright owned by authors.

    Pre-Exposure Prophylaxis (PrEP) as an Additional Tool for HIV Prevention Among Men Who Have Sex With Men in Belgium: The Be-PrEP-ared Study Protocol

    Abstract:

    Background: Pre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent HIV. With the approval of Truvada as daily PrEP by the European Commission in August 2016, individual European Member states prepare themselves for PrEP implementation following the examples of France and Norway. However, context-specific data to guide optimal implementation is currently lacking. Objective: With this demonstration project we evaluate whether daily and event-driven PrEP, provided within a comprehensive prevention package, is a feasible and acceptable additional prevention tool for men who have sex with men (MSM) at high risk of acquiring HIV in Belgium. The study’s primary objective is to document the uptake, acceptability, and adherence to both daily and event-driven PrEP, while several secondary objectives have been formulated including impact of PrEP use on sexual behavior. Methods: The Be-PrEP-ared study is a phase 3, single-site, open-label prospective cohort study with a large social science component embedded in the trial. A total of 200 participants choose between daily or event-driven PrEP use and may switch, discontinue, or restart their regimen at the 3-monthly visits for a duration of 18 months. Data are collected on several platforms: an electronic case report form, a Web-based tool where participants register their sexual behavior and pill use, a more detailed electronic self-administered questionnaire completed during study visits on a tablet computer, and in-depth interviews among a selected sample of participants. To answer the primary objective, the recruitment rate, (un)safe sex behavior during the last 6 months, percentage of reported intention to use PrEP in the future, retention rates in different regimens, and attitudes towards PrEP use will be analyzed. Adherence will be monitored using self-reported adherence, pill count, tenofovir drug levels in blood samples, and the perceived skills to adhere. Results: All participants are currently enrolled, and the last study visit is planned to take place around Q3 2018. Conclusions: As PrEP is not yet available in Belgium for use, this study will provide insights into how to optimally implement PrEP within the current health care provision and will shape national and European guidelines with regard to the place of PrEP in HIV prevention strategies. ClinicalTrial: EU Clinical Trial 2015-000054-37; https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000054-37/BE (Archived by WebCite at http://www.webcitation.org/6nacjSdmM).

  • Online tobacco cessation training. Image sourced and copyright owned by authors.

    Adaptation, Implementation Plan, and Evaluation of an Online Tobacco Cessation Training Program for Health Care Professionals in Three Spanish-Speaking Latin...

    Abstract:

    Background: Tobacco cessation training programs to treat tobacco dependence have measureable effects on patients’ smoking. Tobacco consumption in low- and middle-income countries (LMICs) is high and slowly decreasing, but these countries usually lack measures to face the epidemic, including tobacco cessation training programs for health professionals and organizations. Based on a previous online smoking cessation training program for hospital workers in Spain, the Fruitful Study aims to increase smoking cessation knowledge, attitudes, self-confidence, and performance interventions among health care professionals of three Spanish-speaking low- and middle-income Latin American and Caribbean (LAC) countries. Objective: The purpose of this paper is to describe the methodology and evaluation strategy of the Fruitful Study intended to adapt, implement, and test the effectiveness of an online, evidence-based tobacco cessation training program addressed to health professionals from Bolivia, Guatemala, and Paraguay. Methods: This study will use a mixed-methods design with a pre-post evaluation (quantitative approach) and in-depth interviews and focus groups (qualitative approach). The main outcomes will be (1) participants’ attitudes, knowledge, and behaviors before and after the training; and (2) the level of implementation of tobacco control policies within the hospitals before and after the training. Results: To date, adaptation of the materials, study enrollment, and training activities have been completed. During the adaptation, the main mismatches were language background and content adaptation. Several aids were developed to enable students’ training enrollment, including access to computers, support from technicians, and reminders to correctly complete the course. Follow-up data collection is in progress. We have enrolled 281 hospital workers. Results are expected at the beginning of 2017 and will be reported in two follow-up papers: one about the formative evaluation and the other about the summative evaluation. Conclusions: There is a need to learn more about the cultural and content elements that should be modified when an online tobacco cessation training program is adapted to new contexts. Special attention should be given to the personal and material resources that could make the implementation possible. Results from the Fruitful Study may offer a new approach to adapting programs to LMICs in order to offer education solutions with the use of emerging and growing communication technologies. ClinicalTrial: Clinicaltrials.gov NCT02718872; https://clinicaltrials.gov/ct2/show/NCT02718872 (Archived by WebCite at http://www.webcitation.org/6mjihsgE2)

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  • Does a novel wearable device improve health related quality of life of patients with an ostomy? A prospective, observational, crossover study protocol.

    Date Submitted: Feb 12, 2017

    Open Peer Review Period: Feb 20, 2017 - Mar 6, 2017

    Background: Ostomy surgeries involving the placement of an ostomy bag (colostomy, ileostomy, urostomy, etc.) have been shown to have a negative impact on health-related quality of life. To date, no s...

    Background: Ostomy surgeries involving the placement of an ostomy bag (colostomy, ileostomy, urostomy, etc.) have been shown to have a negative impact on health-related quality of life. To date, no studies have been conducted examining what impact, if any, wearable biosensors have on health-related quality of life of ostomy patients. Objective: In the present study, we plan to assess quality of life of ostomy patients using the Ostom-i alert sensor, a portable, wearable, Bluetooth linked biosensor that facilitates easier ostomy bag output measurements. We hypothesize that using the Ostom-i alert sensor will result in an improved, ostomy specific health related quality of life as compared to baseline measurement before the use of the sensor. Methods: A total of 20 ostomy patients will be screened and recruited to participate in this prospective, observational, crossover trial using Ostom-i alert sensor for one month. The primary outcome of this study will compare ostomy specific health related quality of life at baseline (prior to Ostom-i alert sensor use) to ostomy specific health-related quality of life after 2 and 4 weeks of Ostom-i use by utilizing the City of Hope Quality of Life Questionnaire for patients with an Ostomy (CoH-QOL-Ostomy). Secondary outcomes of general health related quality of life and adjustment to ostomy will be evaluated using the Medical Outcomes Study 36-item short form health survey (SF-36) and the Olbrisch Ostomy Adjustment Scale Short Form 2 (OAS-SF2). Results: Proposed benefits of mobile, internet linked personal health monitors such as the Ostom-i include a reduction in the cost of care by reducing resource utilization and infection rates, improving patient-provider communication, reducing time spent as an in-patient as well as improved quality of life. Prior studies have demonstrated decreased health related quality of life in patients with an ostomy bag. We aim to examine the extent to which the Ostom-i™ alert sensor affects health related quality of life of its users. Conclusions: The Ostom-i alert sensor has the potential to improve quality of life of users by giving them freedom and confidence to partake in daily activities with the knowledge that they can check how full their ostomy bag is in a private, discrete manner. Clinical Trial: clinicalTrials.gov: NCT02319434, first registered 15 December 2014.

  • Impact of a pharmaceutical intervention to improve adherence of inhaled medication in asthma and COPD patients

    Date Submitted: Feb 17, 2017

    Open Peer Review Period: Feb 20, 2017 - Mar 6, 2017

    Background: Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitali...

    Background: Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitalized due to exacerbations. Reasons for uncontrolled disease are manifold, but are frequently associated with poor inhalation technique and non-adherence to the prescribed treatment plan which may cause substantial mortality, morbidity, and cost to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase respectively maintain treatment adherence, particularly in chronic diseases, is of major clinical importance. Objective: The primary objective of this study is to measure medication adherence in patients with chronic obstructive lung diseases such as asthma and COPD, and to investigate the impact of a reminder on disease outcomes and quality of life. Methods: In this ongoing prospective single-blind randomized controlled study, the adherence to inhaled medication is analyzed over a six-months period in at least 154 in- and outpatients with asthma or COPD, who have experienced at least one exacerbation during the last year. Adherence is measured using electronic data capture devices which save date and time of each inhalative device actuation and transfer these data daily via wireless-connection to a web-based database. Patients are randomly assigned to an intervention, respectively control group. Patients assigned to the intervention group will receive audio reminder and support calls in case medication is not been taken as prescribed or if rescue medication is used more frequently than prespecified in the study protocol. During the study, participants are assessed every two months. Results: Recruitment started in January 2014 and to date, a total of 169 patients have been recruited. Follow-up assessments are still ongoing. The study will be concluded in the first quarter of 2017. Data analysis will take place during 2017. Conclusions: To date, only few studies have investigated medication adherence in patients with chronic obstructive lung diseases. With the prospective study design and the use of state-of-the-art devices for measuring adherence, we expect scientifically relevant and clinically meaningful results that will have a substantial and positive impact on the provision of health care in chronically ill patients with asthma or COPD. Clinical Trial: ClinicalTrials.gov: NCT02386722; https://clinicaltrials.gov/ct2/show/NCT02386722 (archives by WebCite at http://www.webcitation.org/6oJq1fel0)

  • Testing the effectiveness of a primary care intervention to improve uptake of colorectal cancer screening: A randomised controlled trial protocol.

    Date Submitted: Feb 6, 2017

    Open Peer Review Period: Feb 19, 2017 - Mar 5, 2017

    Background: Screening for colorectal cancer (CRC) significantly reduces mortality associated with this disease. In Australia, the National Bowel Cancer Screening Program provides regular faecal occult...

    Background: Screening for colorectal cancer (CRC) significantly reduces mortality associated with this disease. In Australia, the National Bowel Cancer Screening Program provides regular faecal occult blood tests (FOBT) for those aged 50-74, however, participation rates in the program have plateaued at 36%. Considering low uptake in the National Bowel Cancer Screening Program it is necessary to explore alternate methods to increase CRC screening rates. Primary care is a promising adjunct setting to test methods to increase CRC screening participation. Primary care guidelines support the recommendation and provision of CRC screening in primary care patients. Those in the National Bowel Cancer Screening Program target age range frequently present to their primary care provider. Objective: This study tests the effect that printed advice on screening, provision of a free point-of-care FOBT and face-to-face primary care provider endorsement of screening delivered in an Australian primary care has on CRC screening uptake. Methods: Primary care patients presenting for an appointment with their primary care provider complete a touchscreen survey to determine eligibility for the trial. Those aged 50-74, at average risk of CRC, who have not have had a FOBT in the past two years or a colonoscopy in the past five years are eligible to participate in the trial. Trial participants are randomised to the intervention or usual care group by day of attendance at the practice. The intervention consists of provision of a FOBT, a printed information sheet and primary care provider endorsement to complete the FOBT. The usual care group receives no additional care. Results: The primary outcome is completion of CRC screening six weeks after recruitment. The proportion of patients completing CRC screening will be compared between trial groups using a logistic regression model. Conclusions: Protocol paper only Clinical Trial: This study was registered with the Australian New Zealand Clinical Trials Registry on 15th September 2016 (ACTRN12616001299493). The Universal Trial Number (UTN) for this trial is U1111-1185-6120.

  • Foot Reflexology Therapy for Non-Specific Low Back Pain Condition: A Protocol for A Randomized Controlled Trial

    Date Submitted: Feb 7, 2017

    Open Peer Review Period: Feb 19, 2017 - Mar 5, 2017

    Background: Non-specific low back pain (NSLBP) is one of the most common physical ailments affecting millions of people worldwide. This condition constitutes a significant public health problem and wa...

    Background: Non-specific low back pain (NSLBP) is one of the most common physical ailments affecting millions of people worldwide. This condition constitutes a significant public health problem and was listed as a prevalent health complaint in most societies. Even though there are many anecdotal claims for reflexology in the treatment of various conditions such as a migraine, arthritis and multiple sclerosis, but very little clinical evidence exist for reflexology on the management of low back pain per se. Objective: This study aim to evaluate the effects of foot reflexology therapy as an adjunctive treatment to the Malaysian low back pain standard care in relieving pain and promoting health related quality of life in people (HRQoL) with NSLBP. Methods: This is parallel randomized controlled trial in the reflexology therapy clinic, Kuala Terengganu, Malaysia; 100 people with non-specific low back pain will be allocated into one of two groups, using web-based application based on block randomisation. Outcome assessor and subjects will be blinded for group allocation. The control group will receive standard care, while the intervention group will receive standard care plus eight sessions, twice a week of foot reflexology therapy. The primary and secondary outcome variables are pain intensity and HRQoL respectively. Results: Outcome measures will be undertaken at pre-intervention (week 0), interim (week 1, week 2, week 3, week 4), post-intervention (week 6) and follow-up (week 10). Conclusions: This will be the first trail to compare the foot reflexology therapy with control group among people who medically diagnosed with NSPLB in Malaysia. The result of this study will contribute to better management of this population. Clinical Trial: This trail is registered in ClinicalTrials.gov, with the ID number of NCT02887430

  • Biometrics & Policing: A protocol for multichannel sensor data collection and exploratory analysis of contextualized psychophysiological response during law enforcement operations

    Date Submitted: Feb 13, 2017

    Open Peer Review Period: Feb 13, 2017 - Feb 22, 2017

    Background: Stress experienced by law enforcement officers is often extreme and is in many ways unique from other professions. Although past research on officer stress is informative, it is limited, a...

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

  • A systematic review on the effectiveness of school-based sex education program for youth in Asia

    Date Submitted: Feb 11, 2017

    Open Peer Review Period: Feb 11, 2017 - Feb 25, 2017

    Background: This is a systematic review to assess the effectiveness of school-based sex education program among youngsters aged 12 or more who are going to school.All school going students with a prog...

    Background: This is a systematic review to assess the effectiveness of school-based sex education program among youngsters aged 12 or more who are going to school.All school going students with a program of sex education as a part of their school are eligible.This review presents the finding from controlled school-based sex education intervention in promoting change in behavior toward sex, risk factors, self-hygiene.All the articles of Randomized control trial, cluster randomized trial, non-randomized trial and quasi-experiment done in any country of Asia are eligible for the study. All the article will be screened as per the inclusion and exclusion criteria and take care of duplicate article by Rev man software. This will be done anonymously by two researchers.After the screening and solving the conflict if any arise will be solved by discussing with the primary author.All the article will be screened by consort guideline and will be provided narrative analysis. Objective: The objective of the review is to find whether the school based- sex education program are effective in changing the behavior of young in controlling HIV, and STI. Methods: We will search the following electronic bibliographic database: MEDLINE, Embase, PUBMED, OVID, and the Cochrane Central Register of Controlled Trials (CENTRAL) for published peer-reviewed journal articles; and ClinicalTrials.gov and the World Health Organization's (WHO) International Clinical Trials Registry Platform for prospective trials; AIDS Education and Global Information System (AEGIS) and the Centers for Disease Control and Prevention (CDC), UNAIDS, the WHO and the National Health Service (NHS). Studies published between January 2000 and the date the search are run will be sought.The searches will be run just before the final analyses and further studies retrieved for inclusion. We will hand searched the reference lists of all relevant papers from manipal university.The search strategy will include only terms relating to or describing the intervention. The terms will be Combined with the Cochrane MEDLINE filter for controlled trials of interventions.The search terms will be adapted for use with other bibliographic databases in combination with database-specific filters for controlled trials, where these are available. Pubmed search strategy:- 1 sexual health education OR sex education OR Adolescent sex education OR reproductive health education 2 High school OR middle school OR secondary school 3 1 AND 2 4 race OR ethnicity OR black OR african american OR asian OR causation 5 3 AND (sexual orientation OR sexual behaviour) The search will be restricted to: Studies published in english at the time of search Studies conducted in asia Studies conducted in school setting Search string is as follow- effect[All Fields] AND ("schools"[MeSH Terms] OR "schools"[All Fields] OR "school"[All Fields]) AND based[All Fields] AND ("sex education"[MeSH Terms] OR ("sex"[All Fields] AND "education"[All Fields]) OR "sex education"[All Fields]) AND ("Intervention (Amstelveen)"[Journal] OR "intervention"[All Fields] OR "Interv Sch Clin"[Journal] OR "intervention"[All Fields]) AND ("behaviour"[All Fields] OR"behavior"[MeSH Terms] OR "behavior"[All Fields]) AND ("adolescent"[MeSH Terms] OR "adolescent"[All Fields]) Results: The result will be analysis on outcome variables that measure the effectiveness of school-based sex education program.information processing skills (reproductive health, boys, and girls), HIV, STI, students perceptions, risk behavior. change in the percentage of HIV, STI from baseline to last available article.All the article will be given importance on the intervention like the change of behavior.At last, the result will be shared with all the national health authority, WHO, UNICEF. Conclusions: The conclusion will be provided after the analysis of the systematic review. Clinical Trial: Method and content were approved by the Cochrane systematic review and published the protocol in their database.

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