JMIR Publications


The Karma system is currently undergoing maintenance (Monday, January 29, 2018).
The maintenance period has been extended to 8PM EST.

Karma Credits will not be available for redeeming during maintenance.

JMIR Research Protocols

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

Advertisement

Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed-indexed journal, publishing peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

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

While the original focus was on eHealth studies, JMIR Res Protoc now publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions.

JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central.

Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort.

JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal.

JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols.

JMIR Res Protoc provides a "dry-run" for peer-review of the final results paper, and allows feedback/critique of the methods, often while they still can be fixed.

JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced.

JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods.

Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine.

Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others).

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

 
 

Recent Articles:

  • Source: Exist.io; Copyright: Fitbit; URL: https://exist.io/blog/fitness-tracker-sleep/; License: Fair use/fair dealings.

    Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with...

    Abstract:

    Background: Thyrotoxicosis is a common disease caused by an excess of thyroid hormones. The prevalence of thyrotoxicosis about 2% and 70-90% of thyrotoxicosis cases are caused by Graves' disease, an autoimmune disease, which has a high recurrence rate when treated with antithyroid drugs such as methimazole or propylthiouracil. The clinical symptoms and signs of thyrotoxicosis include palpitation, weight loss, restlessness, and difficulty sleeping. Although these clinical changes in thyrotoxicosis can be detected by currently available wearable activity trackers, there have been few trials of the clinical application of wearable devices in patients with thyrotoxicosis. Objective: The aim of this study is to investigate the clinical applicability of wearable device-generated data to the management of thyrotoxicosis. We are analyzing continuously monitored data for heart rate, physical activity, and sleep in patients with thyrotoxicosis during their clinical course after treatment. Methods: Thirty thyrotoxic patients and 10 control subjects were enrolled in this study at Seoul National University Bundang Hospital. Heart rate, physical activity, and sleep are being monitored using a Fitbit Charge HR or Fitbit Charge 2. Clinical data including anthropometric measures, thyroid function test, and hyperthyroidism symptom scale are recorded. Results: Study enrollment began in December 2016, and the intervention and follow-up phases are ongoing. The results of the data analysis are expected to be available by September 2017. Conclusions: This study will provide a foundational feasibility trial of the clinical applications of biosignal measurements to the differential diagnosis, prediction of clinical course, early detection of recurrence, and treatment in patients with thyrotoxicosis. Clinical Trial: ClinicalTrials.gov NCT03009357; https://clinicaltrials.gov/ct2/show/NCT03009357 (Archived by WebCite at http://www.webcitation.org/6wh4MWPm2)

  • Source: Pexels; Copyright: Carlos R; URL: https://www.pexels.com/photo/woman-with-black-dress-using-a-smartphone-132589/; License: Public Domain (CC0).

    Healthy Body Image Intervention Delivered to Young Women via Facebook Groups: Formative Study of Engagement and Acceptability

    Abstract:

    Background: There is increasing interest in using social media sites such as Facebook to deliver health interventions so as to expose people to content while they are engaging in their usual social media habit. This formative intervention development study is novel in describing a preliminary test of using the secret group feature of Facebook to deliver a behavioral intervention targeting users of indoor tanning beds to reduce their risk of skin cancer. Intervention content was designed to challenge body image-related constructs associated with indoor tanning through the use of dissonance-inducing content. Objective: To evaluate engagement with and acceptability of using a secret Facebook group to deliver a healthy body image intervention to young women engaged in indoor tanning. Methods: Seventeen young women completed a baseline survey and joined a secret Facebook group with intervention content delivered via daily posts for 4 weeks. Engagement data was extracted and acceptability was measured via a follow-up survey. Results: The study had a high retention rate (94%, [16/17]). On average, posts were viewed by 91% of participants, liked by 35%, and commented on by 26%. The average comment rate was highest (65%) for posts that elicited comments by directly posing questions or discussion topics to the group. Average intervention acceptability ratings were highly positive and participants reported feeling connected to the group and its topic. Average rates of past 1-month indoor tanning reported following the intervention were lower than the baseline rate (P=.08, Cohen d=0.47). Conclusions: This study is novel in demonstrating participant engagement with and acceptability of using Facebook secret groups to deliver a dissonance-inducing intervention approach that utilizes group-based discussions related to body image. The study is also unique within the field of skin cancer prevention by demonstrating the potential value of delivering an indoor tanning intervention within an interactive social media format. The findings suggest that Facebook metrics of intervention post engagement (ie, likes and comments) may vary based on post types and that designing specifically labeled discussion posts may be helpful for soliciting engagement as well as challenging beliefs.

  • A-V Impulse Foot Compression System. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/2/e58/; License: Creative Commons Attribution (CC-BY).

    Effect of Impulsive Compression Treatment on Postoperative Complications After Open Peripheral Vascular Revascularization (In Situ): Protocol for a...

    Abstract:

    Background: In patients with critical leg ischemia (CLI), the standard operative choice is an in situ bypass to the lower extremity to improve the patients´ prognosis and quality of life. Postoperative complications after surgery occur in 18 % of the patients, prolonging hospitalization and convalescence. The main operative complication is edema. This can be prevented by early mobilization or stimulation of the natural venous pump in the leg. Objective: To investigate whether compression therapy with foot pump reduces postoperative edema, facilitates wound healing of the operation wounds, promotes healing of ischemic ulcers, and shortens hospitalization, increasing and improving the patient’s subjective quality of life faster. Methods: The protocol is designed as a randomized, unblinded prospective study with 50 patients in each group. Standard postoperative routines after bypass surgery, including short-stretch bandaging of the operated legs, are compared to supportive stimulation of the venous pump by an impulsive compression foot pump. The postoperative edema of the leg is measured 10 cm below the patella and 8 cm proximal to the medial malleolus. Measurements are performed preoperatively, 1 and 4 days postoperatively and at discharge. Results: The primary endpoint is reduction of leg edema by at least 50%. The secondary endpoint includes earlier mobilization in the pump group and decreased length of stay in hospital. Quality of life is evaluated through the European Health Related Quality of Life Questionnaire 5 Dimensions (EQ-5D) and Vascular Quality of Life Questionnaire-6 (VascuQol-6) questionnaires. The start of the study is February 1, 2018, and the end of the study is February 1, 2020. First results will be available April 2020. Conclusions: In orthopedic surgery of the lower extremities, the use of foot pumps has shown a reduction of edema and thrombosis in risk patients. Although important positive effects may be expected after vein bypass surgery, no reports have yet investigated the use of the device in vascular-operated patients and no analysis or meta Cochrane reviews are available in this field. Trial Registration: ClinicalTrials.gov NCT03192982; https://clinicaltrials.gov/ct2/show/NCT03192982 (Archived by WebCite at http://www.webcitation.org/6xMZJ06dw)

  • Pharmacist counseling a patient. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/2/e57/; License: Creative Commons Attribution (CC-BY).

    Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Protocol for a Randomized Controlled Trial Investigating Effects on...

    Abstract:

    Background: Preventive treatment goals for blood pressure and cholesterol levels continue to be unmet for many coronary patients. The effect of drug treatment depends on both its appropriateness and the patients’ adherence to the treatment regimen. There is a need for adherence interventions that have a measurable effect on clinical outcomes. Objective: This study aims to evaluate the effects on treatment goals of an intervention designed to improve patient adherence and treatment quality in secondary prevention of coronary heart disease. A protocol for the prespecified process evaluation of the trial is published separately. Methods: The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a prospective, randomized, outcomes-blinded trial designed to compare individualized follow-up by a clinical pharmacist using motivational interviewing (MI) and medication review with standard follow-up. Patients were randomized to 2 groups after stratification according to their beliefs about medicines. After standard follow-up at the cardiology clinic, patients in the intervention group are seen individually by a clinical pharmacist 2 to 5 times as required over 7 months, at the clinic. The pharmacist reviews each patient’s medication and uses MI to manage any problems with prescribing and adherence. The primary study outcome is the proportion of patients who have reached the treatment goal for low-density lipoprotein cholesterol by 12 months after discharge. Secondary outcomes are the effects on patient adherence, systolic blood pressure, disease-specific quality of life, and health care use. Results: The protocol for this study was approved by the Regional Ethics Committee, Linköping, in 2013. Enrollment started in October 2013 and ended in December 2016 when 417 patients had been included. Follow-up data collection will conclude in March 2018. Publication of the primary and secondary outcome results from the MIMeRiC trial is anticipated in 2019. Conclusions: The MIMeRiC trial will assess the effectiveness of an intervention involving medication reviews and individualized support. The results will inform the continued development of support for this large group of patients who use preventive medicines for lifelong treatment. The design of this adherence intervention is based on a theoretical framework and is the first trial of an intervention that uses beliefs about medicines to individualize the intervention protocol. Trial Registration: ClinicalTrials.gov NCT02102503; https://clinicaltrials.gov/ct2/show/NCT02102503 (Archived by WebCite at http://www.webcitation.org/6x7iUDohy)

  • Source: Pixabay; Copyright: maxlkt; URL: https://pixabay.com/en/hospice-care-elderly-old-1750928/; License: Public Domain (CC0).

    Evaluating the CARE4Carer Blended Care Intervention for Partners of Patients With Acquired Brain Injury: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Support programs for partners of patients with acquired brain injury are necessary since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psychoeducation, skill building, problem solving, and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. Objective: This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. Methods: A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. Results: The effect of the intervention on the primary and secondary outcome measures will be determined. Additional a process evaluation will be conducted. Conclusions: The findings of this study will be used to improve the care for partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. Trial Registration: Dutch Trial Register NTR6197; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6197 (Archived by WebCite at http://www.webcitation.org/6xHBAxx0y)

  • Email intervention (montage). Source: Cancer Care Ontario / Mockdrop.io; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/1/e11/; License: Creative Commons Attribution (CC-BY).

    Testing Behavior Change Techniques to Encourage Primary Care Physicians to Access Cancer Screening Audit and Feedback Reports: Protocol for a Factorial...

    Abstract:

    Background: Cancer Care Ontario’s Screening Activity Report (SAR) is an online audit and feedback tool designed to help primary care physicians in Ontario, Canada, identify patients who are overdue for cancer screening or have abnormal results requiring follow-up. Use of the SAR is associated with increased screening rates. To encourage SAR use, Cancer Care Ontario sends monthly emails to registered primary care physicians announcing that updated data are available. However, analytics reveal that 50% of email recipients do not open the email and less than 7% click the embedded link to log in to their report. Objective: The goal of the study is to determine whether rewritten emails result in increased log-ins. This manuscript describes how different user- and theory-informed messages intended to improve the impact of the monthly emails will be experimentally tested and how a process evaluation will explore why and how any effects observed were (or were not) achieved. Methods: A user-centered approach was used to rewrite the content of the monthly email, including messages operationalizing 3 behavior change techniques: anticipated regret, material incentive (behavior), and problem solving. A pragmatic, 2x2x2 factorial experiment within a multiphase optimization strategy will test the redesigned emails with an embedded qualitative process evaluation to understand how and why the emails may or may not have worked. Trial outcomes will be ascertained using routinely collected administrative data. Physicians will be recruited for semistructured interviews using convenience and snowball sampling. Results: As of April 2017, 5576 primary care physicians across the province of Ontario, Canada, had voluntarily registered for the SAR, and in so doing, signed up to receive the monthly email updates. From May to August 2017 participants received the redesigned monthly emails with content specific to their allocated experimental condition prompting use of the SAR. We have not yet begun analyses. Conclusions: This study will inform how to communicate effectively with primary care providers by email and identify which behavior change techniques tested are most effective at encouraging engagement with an audit and feedback report. Trial Registration: ClinicalTrials.gov NCT03124316; https://clinicaltrials.gov/ct2/show/NCT03124316 (Archived by WebCite at http://www.webcitation.org/6w2MqDWGu)

  • Source: The Authors / Unsplash; Copyright: The Authors / Simon Hattinga Verschure; URL: https://unsplash.com/photos/WNevBlZWCKA; License: Creative Commons Attribution (CC-BY).

    National Food, Nutrition, and Physical Activity Survey of the Portuguese General Population (2015-2016): Protocol for Design and Development

    Abstract:

    Background: The assessment of food consumption data using harmonized methodologies at the European level is fundamental to support the development of public policies. Portugal is one of the countries with the most outdated information on individual food consumption. Objective: The objective of this study was to describe the design and methodology of the National Food, Nutrition and Physical Activity Survey, 2015-2016, developed to collect national and regional data on dietary habits, physical activity (PA), and nutritional status, in a representative sample of the Portuguese general population (3 months-84 years). Methods: Participants were selected by multistage sampling, using the National Heath Registry as the sampling frame. Data collection, during 12 months, was harmonized according to European guidelines (EU-MENU, European Food Safety Authority [EFSA]). Computer-assisted personal interviewing (CAPI) was performed on a specific electronic platform synchronized with nutritional composition data and considering the FoodEx2 classification system. Dietary assessment was performed using 24-hour recalls (two nonconsecutive, 8-15 days apart) or food diaries in the case of children aged <10 years, complemented with a food propensity questionnaire; PA data (International Physical Activity Questionnaire [IPAQ], the Activity Choice Index [ACI], and 4-days PA diaries); sociodemographic data, and other health-related data were also collected. Results: A sample of 6553 individuals completed the first interview, and 5811 participants completed two dietary assessments. The participation rate among eligible individuals was 33.38% (6553/19,635), considering the first interview, and 29.60% (5811/19,635) for the participants with two completed interviews (about 40% in children and adolescents and 20% in elderly individuals). Results of the survey will be disseminated in national and international scientific journals during 2018-2019. Conclusions: The survey will assist policy planning and management of national and European health programs on the improvement of nutritional status and risk assessment related to food hazards, and the enhancement of PA. The infrastructures and data driven from this Survey are a solid basis to the development of a future national surveillance system on diet, PA, and other health behaviors reproducible over time.

  • Source: Freepik; Copyright: bearfotos; URL: https://www.freepik.com/free-photo/happy-mature-man-speaks-by-phone_1238559.htm; License: Creative Commons Attribution (CC-BY).

    mHealth Technology and Nurse Health Coaching to Improve Health in Diabetes: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. Objective: The objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. Methods: A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A1c (HbA1c), and quality of life measures. Results: Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. Conclusions: This protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback loop by bringing patient-generated data into the EHR. Trial Registration: ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176 (Archived by WebCite at http://www.webcitation.org/6xEQXe1M5)

  • Source: Pixabay; Copyright: Daniel Reche; URL: https://pixabay.com/de/spaziergang-pfad-f%C3%BC%C3%9Fe-trail-tennis-2635038/; License: Public Domain (CC0).

    Reducing Sedentary Time for Obese Older Adults: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Older adults have high rates of obesity and are prone to chronic health conditions. These conditions are in part due to high rates of sedentary time (ST). As such, reducing ST could be an innovative strategy for improving health outcomes among obese older adults. To test this theory, we developed a novel, technology-enhanced intervention to reduce sitting time (I-STAND) and pilot tested it to assess the feasibility, acceptability, and preliminary effects of the intervention on ST and biometric outcomes. Objective: The current paper aims to describe the rationale, design, and methods of the I-STAND sitting reduction pilot trial. Methods: Older adults with obesity (n=60) were recruited from a large health care system and randomized to receive I-STAND or a healthy living intervention. I-STAND combined personal coaching with a technology-enhanced intervention (Jawbone UP band) to cue breaks from sitting. Participants completed self-report and biometric assessments at baseline and 3 months. Additional qualitative results were collected from a subset of I-STAND participants (n=22) to further inform the feasibility and acceptability of the interventions. The primary outcome was total hours of daily sitting time measured by the activPAL device. Secondary outcomes included sit-to-stand transitions, bouts of sitting longer than 30 minutes, physical function, blood pressure, fasting glucose, cholesterol, and depressive symptoms. Results: Study enrollment has ended and data processing is underway. Conclusions: Data from randomized trials on sitting reduction are needed to inform novel approaches to health promotion among older adults with obesity. Our trial will help fill this gap. The methods used in our study can guide future research on using technology-based devices to assess or prompt sedentary behavior reduction, or those interested in behavioral interventions targeting obese older adults with novel approaches Trial Registration: ClinicalTrials.gov: NCT02692560; https://clinicaltrials.gov/ct2/show/NCT02692560 (Archived by WebCite at http://www.webcitation.org/6wppLTWAl)

  • Digital voice technology with real time updates. Source: Image created by the Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2018/2/e27/; License: Creative Commons Attribution (CC-BY).

    Increasing Physical Activity Amongst Overweight and Obese Cancer Survivors Using an Alexa-Based Intelligent Agent for Patient Coaching: Protocol for the...

    Abstract:

    Background: Physical activity has established health benefits, but motivation and adherence remain challenging. Objective: We designed and launched a three-arm randomized trial to test artificial intelligence technology solutions to increase daily physical activity in cancer survivors. Methods: A single-center, three-arm randomized clinical trial with an allocation ration of 1:1:1: (A) control, in which participants are provided written materials about the benefits of physical activity; (B) text intervention, where participants receive daily motivation from a fully automated, data-driven algorithmic text message via mobile phone (Coachtext); and (C) Voice Assist intervention, where participants are provided with an in-home on demand autonomous Intelligent Agent using data driven Interactive Digital Voice Assist on the Amazon Alexa/Echo (MyCoach). Results: The study runs for 5 weeks: a one-week run-in to establish baseline, followed by 4 weeks of intervention. Data for study outcomes is collected automatically through a wearable sensor, and data are transferred in real-time to the study server. The recruitment goal is 42 participants, 14 in each arm. Electronic health records are used to prescreen candidates, with 39 participants recruited to date. Discussion: This study aims to investigate the effects of different types of intelligent technology solutions on promoting physical activity in cancer survivors. This innovative approach can easily be expanded and customized to other interventions. Early lessons from our initial participants are helping us develop additional advanced solutions to improve health outcomes. Trial Registration: Retrospectively registered on July 10, 2017 at ClinicalTrials.gov: NCT03212079; https://clinicaltrials.gov/ct2/show/NCT03212079 (Archived by WebCite at http://www.webcitation.org/6wgvqjTji)

  • Visual Probe Task for attention bias assessment and modification (montage). Source: The Authors / Mockdrop.io; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/2/e41/; License: Creative Commons Attribution (CC-BY).

    Attention Bias in Individuals with Addictive Disorders: Systematic Review Protocol

    Abstract:

    Background: Globally, substance disorders, particularly that of opiate use, cannabis use, and stimulant use disorders, are highly prevalent. Psychological treatments are an integral aspect of intervention, but a proportion of individuals still relapse despite having received such an intervention. Recently, the dual-process theory proposed that the unconscious processes of attention biases are responsible for these relapses. Prior meta-analyses have reported the presence of attention bias in alcohol and tobacco use disorders. More recent research has examined attention bias and its effectiveness in opiate use, cannabis use, and stimulant use disorder. The evidence syntheses to date have not examined whether attention bias is present in these disorders and could be subjected to manipulation. This is important information and would support the introduction of psychological interventions for attention bias for such patients. Such psychological interventions would help individuals maintain their abstinence and minimize the risk of relapse. Objective: This paper aims to undertake a systematic review to synthesize the existing evidence for the presence of attention bias in all the disorders mentioned above, and to determine the clinical efficacy of attention bias modification. Methods: A systematic review will be conducted. A search will be conducted on the respective databases up till 2017. Selection of the studies will be determined by the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. Quality assessment of the included studies will be assessed using the Cochrane Risk of Bias tool. A narrative synthesis will be conducted, with a meta-analysis considered only if there are sufficient studies for statistical analysis. Results: The results of the systematic review will be available 12 months after the publication of this protocol. Conclusions: This review is important as it will support the introduction of psychological interventions for attention bias for such patients. Such psychological interventions would help individuals maintain their abstinence and minimize the risk of relapse.

  • Source: Flickr; Copyright: Raelene Gutierrez; URL: https://www.flickr.com/photos/raes_antics/5447101634; License: Creative Commons Attribution (CC-BY).

    Influence of Radiofrequency Electromagnetic Fields on the Fertility System: Protocol for a Systematic Review and Meta-Analysis

    Abstract:

    Background: Due to the increased number of users of mobile phones, tablets, and other devices over the past few years, concerns about the potential impact of mobile phones on health are growing. The influence of mobile phone exposure on male fertility has been studied in recent years. Other research has shown that electromagnetic fields (EMFs) increase macrophages in the corpus luteum and growing follicles. Due to conflicting results among studies and since no systematic review has been performed to analyze the effects of radiofrequency EMF exposure from electronic devices on the fertility system in recent years, this evidence-based study is necessary. Objective: The main objectives of this study are to determine the best evidence associated with the influence of radiofrequency EMFs on the fertility system and to provide insight into a potential mechanism using our observations. Methods: In this systematic review, the databases and gray literature will be searched with no language and date limitation. The following databases will be searched: Cochrane Library, MEDLINE, PubMed, EMBASE, CINAHL, ProQuest, Scopus, Science Direct, Google Scholar, and other Persian databases. The combination of the Medical Subject Heading terms “radiofrequency electromagnetic” and “male reproductive system” or “female reproductive system” will be searched. Observational study designs will be included but case reports, case series, reviews, and letters to the editor will be excluded. Papers selected for retrieval will be evaluated by two independent referees for methodological validation before entering a review using the Newcastle-Ottawa Scale for nonrandomized studies and cohort studies. Results: The results of this study will be submitted to a peer-reviewed journal for publication and also presented at PROSPERO. Conclusions: This systematic review will provide evidence-based data on the effect of radiofrequency EMFs on the fertility system. This article will also classify the harmful effect of radiofrequency waves on primary and secondary infertility. This study could be useful for decreasing infertility. This is important because the rate of infertility is growing, leading to negative outcomes for couples and the health care system. Trial Registration: PROSPERO CRD42017072462; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=72462 (Archived by WebCite at http://www.webcitation.org/6wjiE9R2q)

Citing this Article

Right click to copy or hit: ctrl+c (cmd+c on mac)

Latest Submissions Open for Peer-Review:

View All Open Peer Review Articles
  • Thrive With Me: Protocol to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence among Men who have Sex with Men

    Date Submitted: Feb 20, 2018

    Open Peer Review Period: Feb 20, 2018 - Mar 6, 2018

    Background: The rate of viral suppression among persons 13 years of age and older residing in 37 states and the District of Columbia in 2014 was 58%, leaving considerable opportunity for onward transm...

    Background: The rate of viral suppression among persons 13 years of age and older residing in 37 states and the District of Columbia in 2014 was 58%, leaving considerable opportunity for onward transmission and contributing to poor health outcomes. Men who have sex with men (MSM) represent one of the most at-risk groups in the US. There is a clear and continued need for innovative adherence support programs to optimize viral suppression. To address this gap, we designed and are implementing a randomized controlled trial (RCT) to test the efficacy of the "Thrive with Me" (TWM) intervention for men who have sex with men (MSM) living with HIV. Critical components of the protocol are presented. Objective: To rigorously test the efficacy of the TWM to improve antiretroviral therapy (ART) adherence among HIV-positive MSM residing in New York City. Methods: A community advisory board and beta testing were used to obtain feedback from HIV-positive MSM on the overall look and feel of TWM and problems with navigation to finalize intervention components and content. We will enroll 400 HIV-positive MSM residing in the New York City area into a two-arm prospective randomized controlled trial (RCT) and follow them for 17 months. Men in the TWM experimental intervention arm will have access to TWM for 5 months. TWM has three primary components: 1) a private social networking feature; 2) tailored HIV and ART adherence information; and 3) medication reminders, self-monitoring, and reflection. Gamification components include badges and levelling up to increase intrinsic motivation to engage with the intervention. Men randomized to the control condition will view a weekly newsletter for 5 months. The newsletter will be delivered via e-mail and contains information on topics related to HIV with the exception of ART adherence. Study assessments will occur at enrollment and five, eleven, and seventeen months post-enrollment. The primary study outcome is HIV viral load, which is considered an objective indicator of ART adherence. Results: Participant recruitment for the RCT began in October 2016 and the data collection period is anticipated to end in the Fall of 2019. Conclusions: The efficacy trial of TWM will help to fill gaps in understanding about the utility of multi-component technology-based interventions to improve ART adherence among HIV-positive MSM. Of importance is the ability for the results of the TWM trial to inform best practices for conducting technology-based interventions that incorporate social media features. Clinical Trial: ClinicalTrials.gov (NCT02704208); University of Minnesota Institutional Review Board (1504S69721)

  • Effectiveness of a combined Web Based and Ecological Momentary Intervention for incoming first-year university students: Protocol for a three-arm randomised controlled trial.

    Date Submitted: Feb 16, 2018

    Open Peer Review Period: Feb 17, 2018 - Mar 3, 2018

    Background: Alcohol use among university students is common and those who drink often choose to drink heavily (i.e., 4 or more drinks per session for women or 5 or more for men). Web-Based Interventio...

    Background: Alcohol use among university students is common and those who drink often choose to drink heavily (i.e., 4 or more drinks per session for women or 5 or more for men). Web-Based Interventions (WBIs), in which students complete assessments and receive personalized feedback about their alcohol use, and Ecological Momentary Interventions (EMIs), which use mobile devices as a method of delivering intervention information, are two methods that have had some success in reducing alcohol use among university students. Objective: The aim of the current study is to investigate the efficacy of a combined WBI and EMI intervention to reduce alcohol use among university students. Methods: The study is a three-arm RCT. Participants will be randomised into either a WBI + EMI condition, a WBI-only condition, or an assessment only control. Our sample will consist of first-year university students, recruited through five residential colleges at the University of Otago, New Zealand. All participants will complete an online questionnaire at baseline (i.e., before Orientation Week); those in the WBI and WBI + EMI conditions will immediately receive feedback (i.e., the WBI) based on their answers, whereas participants in the control group will receive no feedback. In addition, participants randomised in the WBI + EMI, but not those in the WBI-only or control groups, will receive eight Orientation Week (two per-day on nights with orientation events) and six academic year EMIs (fortnightly). Participants in all conditions will complete brief surveys at the send of the first and second semester and report their weekend alcohol use fortnightly throughout each semester via Ecological Momentary Assessments (EMAs). Results: The primary hypothesis is that participants in the WBI + EMI condition will consume significantly fewer drinks during weekends in their first year at university compared to a WBI only and control group. Secondary hypotheses are that, when compared with the WBI alone and control group, the WBI + EMI condition will report consuming fewer drinks during Orientation Week, report experiencing fewer negative alcohol-related consequences after first semester, and report lower AUDIT-C scores following their first semester. Conclusions: N/A Clinical Trial: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000015246.

  • Protocol for a Systematic Review of Gamified Attention Bias Interventions for Psychiatric Disorders

    Date Submitted: Feb 16, 2018

    Open Peer Review Period: Feb 17, 2018 - Mar 3, 2018

    Background Attention biases are subconscious processes that tend to result in individuals having increased attention for threatening or stimuli with high salience. These biases have been posited to b...

    Background Attention biases are subconscious processes that tend to result in individuals having increased attention for threatening or stimuli with high salience. These biases have been posited to be involved in the psychopathologies of several psychiatric disorders. Technological advances have transformed how such interventions are being delivered. Gamification technologies are increasingly being used for bias modification, as it could help increase motivation to train and make these tasks more engaging. While there are published research on gamification and attention bias, there remains several gaps in knowledge. Objectives The primary objective of the review is thus to identify attention bias modification games that have been published in the literature and to synthesise the current evidence for such interventions and to identify, if possible, the rationale for gamification. The secondary objective is to determine if gamified attention or cognitive bias modification influences secondary outcomes measures, as such anxiety levels or severity of depressive symptoms. Methods To achieve the objective of this review, a systematic review will be undertaken. For the studies that are identified, they will be reviewed by independent assessors and screened against our predefined inclusion and exclusion criteria. The Cochrane risk of bias tool will be used for assessment of the risk of biases in randomised trials that have been identified. The evidence will be synthesized by means of a qualitative synthesis. Results We expect that the review will be completed 12 months from the publication of this protocol. Conclusions This review is pertinent as it helps to provide an overview of the evidence base for gamified attention bias interventions. The findings from the current review will help in the future conceptualisation of gamified attention bias interventions.

  • Protocol for qualitative and quantitative evaluation of ‘Kræftværket’ - a smartphone application designed via co-creation to improve quality of life in adolescents and young adults with cancer.

    Date Submitted: Feb 12, 2018

    Open Peer Review Period: Feb 16, 2018 - Mar 2, 2018

    Background: Adolescents and young adults (AYA) with cancer face significant challenges during the course of medical treatment and recovery from illness. Many struggle with long-term complications in p...

    Background: Adolescents and young adults (AYA) with cancer face significant challenges during the course of medical treatment and recovery from illness. Many struggle with long-term complications in physical, psychosocial, economic and academic domains. Mobile health (mHealth) interventions provide an innovative platform for delivering supportive care, particularly through the utilization of applications (apps) on smartphones and tablets. In order to create a successful mHealth intervention for AYAs, youth input and feedback is essential. The process of co-creation, in which the target app user has a direct role in dictating design and function, was utilized to create the prototype smartphone app for AYA with cancer, TeleKræftværket. Objective: The objective of this article is to describe the protocol for the qualitative and quantitative testing and analysis of the Kræftværket app, a prototype app designed via co-creation for AYAs with cancer to support and improve health-related quality of life (HRQoL). Methods: The app will be evaluated in two phases, a pilot test and an implementation test. In the pilot test, the app will be launched to a test group of 20 AYAs age 15-29 selected for equal representation amongst age group, and treatment status. Patients will be allowed to utilize the app over the course of six weeks, and will complete a baseline and follow-up EORTC QLQ-C30 HRQoL inventory. In addition, participant focus group interviews will be conducted according to a semi-structured interview guide. Resulting data will be analyzed using thematic analysis. Results and appropriate analysis from both the qualitative and quantitative branches of the pilot test will be discussed amongst the research group, and appropriate changes based on user feedback will be made to the app before the final project phase. In the implementation test, the app will be provided and utilized by a sample size of 50 AYAs age 15-29 selected for equal representation amongst gender, age group, diagnosis, and treatment status over the course of 3 months. Participants will be asked to complete a baseline and follow-up EORTC QLQ-C30 HRQoL inventory. Results: Pilot testing is expected to take place in February 2018, and implementation testing is expected to begin May 2018. Conclusions: It is the hope that Kræftværket app will serve as a beneficial and easily utilized product. The process of evaluating the app and its effect on quality of life will address the absence of evidence-based mHealth interventions, and attempt to validate new approaches to benefitting AYA oncology patients in the digital world.

  • Development of a smartphone application for inpatient assessment and post discharge follow-up in child and adolescent psychiatry: a research protocol

    Date Submitted: Feb 15, 2018

    Open Peer Review Period: Feb 15, 2018 - Mar 1, 2018

    Background: New methods for in- and outpatient data collection and for improvning outpatient compliance after discharge are called for. Interactive and mobile technologies i.e. smartphone applications...

    Background: New methods for in- and outpatient data collection and for improvning outpatient compliance after discharge are called for. Interactive and mobile technologies i.e. smartphone applications (apps) have shown promising results, e.g. helping unwell people by offering support and resources. Screening the current condition, including comorbidity, is a vital part of psychiatric care. Comorbid conditions, especially in emergency evaluation, are often missed leading to inaccurate diagnosis and treatment. Also in child and adolescent psychiatric emergency settings, little is known regarding treatment satisfaction. One way of improving diagnostic accuracy and to increase knowledge regarding treatment satisfaction is to use a structured diagnostic process as well as adding a tool to assess consumer satisfaction. Digitalized screening and follow-up has the advantage of making the administration and scoring easier and less time consuming leading to higher response rate. To address the described problems we decided to create a smartphone application: Blå Appen. Objective: The aim of this paper is to describe the development of Blå Appen and to describe the two planned research studies to evaluate the application. Methods: : Blå Appen was developed through 7 different steps: (1) Identifying the need for quick and easy information gathering; (2) identifying desired information and choosing adequate screening questionnaires (3) examining the feasibility in acute psychiatric environment – pilot study; (4) getting organizational acceptance – feasibility study; (5) App construction; (6) Workshop with adolescents - what do the patients think; (7) evaluation - research study 1 & 2. Results: (1) We decided to create a smartphone application based on our previous work on interactive voice response. (2) Eleven validated screening questionnaires were chosen with regard to frequent comorbid states in child & adolescent psychiatry. (3) A pilot study was performed (n=16) indicating good acceptability. In the next step (4) we performed a feasibility study concluding that the method we planned adds value for our patients and no existing solutions were found on the market. The IT department gave their final approval for funding in May 2015. (5) The work resulted in a public procurement. (6) We performed a workshop indicating good feasibility. (7) Two studies will be performed, one in inpatients identifying comorbid conditions and the other to assess outpatient compliance and treatment outcome. Conclusions: A technically advanced and easy-to-use web based mobile phone application corresponding to the unit’s needs was developed and two studies to evaluate its usefulness were planned.

  • Study Protocol of Cost Effectiveness Analysis on Randomised Control Trial of Dental Home Visits (DHVs) in Caries Prevention among Preschool Children

    Date Submitted: Feb 6, 2018

    Open Peer Review Period: Feb 15, 2018 - Mar 1, 2018

    Background: In 2012, nearly 4,000 children in Malaysia were referred for hospital paediatric dental services because of dental caries. Recent research has reported on the effectiveness of dental home...

    Background: In 2012, nearly 4,000 children in Malaysia were referred for hospital paediatric dental services because of dental caries. Recent research has reported on the effectiveness of dental home visits (DHVs) in preventing caries development of caries in young children. DHVs is described as an ongoing relationship between the dentist and his/her patients, providing all aspects of preventive oral health care programme in the presence of the parents at home. The aim of this study is to evaluate the cost effectiveness of DHVs and oral health information in the form of educational leaflets (ELs) in preventing new caries development in young children compared to those receiving only ELs over a period of two years. The cost-effectiveness analysis (CEA) is widely used to inform decision makers about the value of new health programme and interventions. Study methods: This is a collaborative project with the Oral Health Division (OHD) of the Ministry of Health Malaysia. The OHD will provide access to a sub-sample from the National Oral Health of Preschoolers Survey (NOHPS) which was carried out in year 2015. The population of interest is children aged 5 and 6 year-olds from kindergartens in the Selangor state in Malaysia. The study adopted a societal perspective for CEA, all types of resources that are of value to society will be included in analyzing the costs; such as cost to the patient, cost to the provider/institution and indirect costs because of the loss of productivity. Discussion: The amount of young children in Malaysia who have been referred to the hospital children’s dentistry service for severe caries is disturbing. The cost of dental treatment in young children is high due to the severity of the caries which require an aggressive treatment, and the need for general anaesthesia or sedation. This study will provide information on the cost and effectiveness of DHVs in caries prevention of young children in Malaysia.

Advertisement