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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 2017: 4.671).

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.

JRP is compatible with the concept of "Registered Reports" and since May 2018, published protocols receive a Registered Report Identifier (What is a Registered Report Identifier?) and acceptance of the subsequent results paper is "in principle" guaranteed in any JMIR journal and partner journals - see What is a Registered Report?

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).

JMIR Res Protoc is also a unique crowdfunding platform, allowing backers to crowdfund carefully peer-reviewed projects that are not junk-science, and giving researchers additional small funding to conduct and publish their research results. Each article is published with a crowdfunding widget, allowing readers to make nominal donations to the project, which benefit the authors (currently in beta).

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

 
 

Recent Articles:

  • A person with inflammatory bowel disease, experiencing symptom exacerbation (ie, abdominal pain). Source: Pixabay; Copyright: Martin Büdenbender; URL: https://pixabay.com/en/abdominal-pain-attack-medical-2493327/; License: Public Domain (CC0).

    Living With Inflammatory Bowel Disease: Protocol for a Longitudinal Study of Factors Associated With Symptom Exacerbations

    Abstract:

    Background: There has been limited longitudinal research that has comprehensively evaluated possible factors in the exacerbation of inflammatory bowel disease (IBD) symptoms with or without associated inflammation. Evolving Web-based technologies facilitate frequent monitoring of patients’ experiences and allow a fine-grained assessment of disease course. Objective: We aimed to prospectively identify factors associated with symptom exacerbation and inflammation in IBD including psychological functioning, diet, health behaviors, and medication adherence. Methods: Between June 2015 and May 2017, we enrolled adults with IBD, recruited from multiple sources, who had been symptomatically active at least once within the prior 2 years. They completed a Web-based survey every 2 weeks for 1 year and submitted a stool sample at baseline, 26 weeks, and 52 weeks. Any participant reporting a symptom exacerbation was matched to a control within the cohort, based on disease type, sex, age, and time of enrollment; both were sent a supplemental survey and stool collection kit. Biweekly surveys included validated measures of the disease course, psychological functioning, health comorbidities, and medication use. Intestinal inflammation was identified through fecal calprotectin (positive level >250 μg/g stool). Results: There were 155 participants enrolled with confirmed IBD, 66.5% (103/155) with Crohn disease and 33.5% (52/155) with ulcerative colitis, of whom 98.7% (153/155) completed the study. Over the 1-year period, 47.7% (74/155) participants experienced a symptom exacerbation. The results of analyses on risk factors for symptom exacerbations are pending. Conclusions: We recruited and retained a longitudinal IBD cohort that will allow the determination of risk factors for symptom exacerbation with and without inflammation. This will increase understanding of symptom exacerbations among persons with IBD. International Registered Report Identifier (IRRID): RR1-10.2196/11317

  • 3R study logo. Source: Leicester Diabetes Centre; Copyright: Leicester Diabetes Centre; URL: http://www.researchprotocols.org/2018/11/e11289/; License: Creative Commons Attribution (CC-BY).

    The Ready to Reduce Risk (3R) Study for a Group Educational Intervention With Telephone and Text Messaging Support to Improve Medication Adherence for the...

    Abstract:

    Background: Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary prevention of cardiovascular disease is lacking. The Ready to Reduce Risk (3R) study aims to investigate whether a complex intervention, involving group education plus telephone and text messaging follow-up support, can improve medication adherence and reduce cardiovascular risk. Objective: This protocol paper details the design and rationale for the development of the 3R intervention and the study methods used. Methods: This is an open and pragmatic randomized controlled trial with 12 months of follow-up. We recruited participants from primary care and randomly assigned them at a 1:1 frequency, stratified by sex and age, to either a control group (usual care from a general practitioner) or an intervention group involving 2 facilitated group education sessions with telephone and text messaging follow-up support, with a theoretical underpinning and using recognized behavioral change techniques. The primary outcome was medication adherence to statins. The primary measure was an objective, novel, urine-based biochemical measure of medication adherence. We also used the 8-item Morisky Medication Adherence Scale to assess medication adherence. Secondary outcomes were changes in total cholesterol, blood pressure, high-density lipoprotein, total cholesterol to high-density lipoprotein ratio, body mass index, waist to hip ratio, waist circumference, smoking behavior, physical activity, fruit and vegetable intake, patient activation level, quality of life, health status, health and medication beliefs, and overall cardiovascular disease risk score. We also considered process outcomes relating to acceptability and feasibility of the 3R intervention. Results: We recruited 212 participants between May 2015 and March 2017. The 12-month follow-up data collection clinics were completed in April 2018, and data analysis will commence once all study data have been collected and verified. Conclusions: This study will identify a potentially clinically useful and effective educational intervention for the primary prevention of cardiovascular disease. Medication adherence to statins is being assessed using a novel urine assay as an objective measure, in conjunction with other validated measures. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN16863160; http://www.isrctn.com/ISRCTN16863160 (Archived by WebCite at http://www.webcitation.org/734PqfdQw) International Registered Report Identifier (IRRID): DERR1-10.2196/11289

  • Child signing into The Blue App. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/11/e10121/; License: Creative Commons Attribution (CC-BY).

    Issues in Child and Adolescent Inpatient Assessment and Evaluation After Discharge: Protocol for App Development and a Randomized Controlled Trial

    Abstract:

    Background: New methods are needed for collecting data of in- and outpatients and for improving outpatient compliance after discharge. Mobile technologies, such as smartphone apps, have shown promising results, (eg, helping unwell people by offering support and resources). Screening for the condition, including comorbidities, is a vital part of psychiatric care. Comorbid conditions, especially in emergency evaluation, are often missed, leading to inaccurate diagnosis and treatment. One way of improving diagnostic accuracy is to use a structured diagnostic process. Digitalized screening and follow-up have the advantage of making administration and scoring easier and less time consuming, thereby increasing response rate. To address these problems, we decided to create a smartphone app called The Blue App. The Blue App was developed through 6 steps, described in the manuscript. Objective: The aim of this paper is to describe (1) the development of The Blue App and (2) 2 planned research studies to evaluate the app. Methods: Two studies will be performed. Study 1 has a descriptive design, mapping comorbidities before and after the introduction of The Blue App. Study 2 has a randomized controlled design, measuring compliance with outpatient treatments as well as depressive symptoms, rated as changes in Montgomery-Åsberg Depression Scale scores during a 1-year follow-up. Results: We have described app development. Data collection for Study 1 started in autumn 2017. Study 2 will start in autumn 2018. We expect to have enrolled the 150 patients in Study 2 by December 2019. Final results will be published in a scientific journal. Conclusions: A technically advanced and easy-to-use Web-based mobile phone app corresponding to the unit’s needs was developed, and 2 studies are planned to evaluate its usefulness. International Registered Report Identifier (IRRID): RR1-10.2196/10121

  • Child accessing Web-based interactive comic (montage). Source: Image created by the Authors; Copyright: May May Leung; URL: http://www.researchprotocols.org/2018/10/e10682/; License: Creative Commons Attribution (CC-BY).

    Testing a Web-Based Interactive Comic Tool to Decrease Obesity Risk Among Minority Preadolescents: Protocol for a Pilot Randomized Control Trial

    Abstract:

    Background: Childhood obesity is a public health crisis, particularly in low-income, minority populations in the United States. Innovative and technology-enhanced interventions may be an engaging approach to reach at-risk youth and their parents to improve dietary behaviors and feeding practices. However, such tools are limited, especially ones that are theory-based; co-developed with user-centered approaches; tailored to low-income, minority preadolescents; and include parent-focused content. Objective: The objectives of this study include assessing the feasibility and acceptability and exploring the potential impact of the Intervention INC (Interactive Nutrition Comics for urban, minority preadolescents) Web-based tool, which is focused on decreasing childhood obesity risk in black/African American and Latino children aged 9 to 12 years. Methods: Intervention INC is underpinned by the narrative transportation theory, social cognitive theory, and health belief model, and it was co-developed by children and parents from the intended population. The child component consists of a 6-chapter interactive nutrition comic optimized for use on tablet devices, a goal-setting and self-assessment feature, and weekly text/email messages and reminders. The parental component consists of 6 Web-based newsletters, access to the child comic, and weekly text/email messages and reminders. The tool was evaluated using a pilot, single-blind, 2-group randomized controlled study design. Child-parent dyads were randomized to either the experimental or comparison group and assigned to a targeted behavior (increase fruit/vegetable or water intake) based on initial screening questions. Data were collected at 4 time points: baseline (T1), intervention midpoint (T2), intervention endpoint (T3), and 3 months postintervention (T4). Primary measures comprise usage, usability, and feasibility of the Web-based tool. Secondary measures comprise dietary knowledge, preferences, and intake and anthropometric measures (for child) and feeding practices and home food environment (for parent). Results: Study enrollment was completed in November 2017. A total of 89 child-parent dyads were randomized to either the experimental (n=44) or comparison (n=45) group. Data analysis is currently being conducted. Conclusions: This study aims to implement and assess an innovative approach to deliver health messages and resources to at-risk minority preadolescents and their parents. If found to be acceptable, engaging, feasible, and a potential approach to improve dietary behaviors, a full-fledged randomized controlled trial will be conducted to assess its efficacy and potential impact. Trial Registration: ClinicalTrials.gov NCT03165474; https://clinicaltrials.gov/ct2/show/NCT03165474 (Archived by WebCite at http://www.webcitation.org/73122IjgP) International Registered Report Identifier (IRRID): RR1-10.2196/10682

  • Supported housing resident using smart home technology via tablet. Source: The Authors / Summer Foundation Ltd; Copyright: The Authors / Summer Foundation Ltd; URL: https://www.researchprotocols.org/2018/11/e10451/; License: Fair use/fair dealings.

    Evaluating the Use of Smart Home Technology by People With Brain Impairment: Protocol for a Single-Case Experimental Design

    Abstract:

    Background: Smart home technologies are emerging as a useful component of support delivery for people with brain impairment. To promote their successful uptake and sustained use, focus on technology support services, including training, is required. Objective: The objective of this paper is to present a systematic smart home technology training approach for people with brain impairment. In addition, the paper outlines a multiple-baseline, single-case experimental design methodology to evaluate training effectiveness. Methods: Adult participants experiencing acquired brain impairment who can provide consent to participate and who live in housing where smart home technology is available will be recruited. Target behaviors will be identified in consultation with each participant based on his or her personal goals for technology use. Target behaviors may include participant knowledge of the number and type of technology functions available, frequency of smart home technology use, and number of function types used. Usage data will be gathered via log-on smart home technology servers. A smart technology digital training package will also be developed and left on a nominated device (smartphone, tablet) with each participant to use during the trial and posttrial, as desired. Measures of the target behavior will be taken throughout the baseline, intervention, and postintervention phases to provide the evidence of impact of the training on the target behaviors and ascertain whether utilization rates are sustained over time. In addition, trial results will be analyzed using structured visual analysis, supplemented with statistical analysis appropriate to single-case methodology. Results: While ascertaining the effectiveness of this training protocol, study results will offer new insights into technology-related training approaches for people with brain impairment. Preliminary data collection has been commenced at one supported housing site, with further scoping work continuing to recruit participants from additional sites. Conclusions: Evaluation evidence will assist in planning for the smart technology set-up as well as training and support services necessary to accompany the provision of new devices and systems. International Registered Report Identifier (IRRID): RR1-10.2196/10451

  • Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/doctor-speaking-on-phone-and-looking-away_2994300.htm; License: Licensed by JMIR.

    Patterns of Patients’ Interactions With a Health Care Organization and Their Impacts on Health Quality Measurements: Protocol for a Retrospective Cohort Study

    Abstract:

    Background: Data collected by health care organizations consist of medical information and documentation of interactions with patients through different communication channels. This enables the health care organization to measure various features of its performance such as activity, efficiency, adherence to a treatment, and different quality indicators. This information can be linked to sociodemographic, clinical, and communication data with the health care providers and administrative teams. Analyzing all these measurements together may provide insights into the different types of patient behaviors or more accurately to the different types of interactions patients have with the health care organizations. Objective: The primary aim of this study is to characterize usage profiles of the available communication channels with the health care organization. The main objective is to suggest new ways to encourage the usage of the most appropriate communication channel based on the patient’s profile. The first hypothesis is that the patient’s follow-up and clinical outcomes are influenced by the patient’s preferred communication channels with the health care organization. The second hypothesis is that the adoption of newly introduced communication channels between the patient and the health care organization is influenced by the patient’s sociodemographic or clinical profile. The third hypothesis is that the introduction of a new communication channel influences the usage of existing communication channels. Methods: All relevant data will be extracted from the Clalit Health Services data warehouse, the largest health care management organization in Israel. Data analysis process will use data mining approach as a process of discovering new knowledge and dealing with processing data extracted with statistical methods, machine learning algorithms, and information visualization tools. More specifically, we will mainly use the k-means clustering algorithm for discretization purposes and patients’ profile building, a hierarchical clustering algorithm, and heat maps for generating a visualization of the different communication profiles. In addition, patients’ interviews will be conducted to complement the information drawn from the data analysis phase with the aim of suggesting ways to optimize existing communication flows. Results: The project was funded in 2016. Data analysis is currently under way and the results are expected to be submitted for publication in 2019. Identification of patient profiles will allow the health care organization to improve its accessibility to patients and their engagement, which in turn will achieve a better treatment adherence, quality of care, and patient experience. Conclusions: Defining solutions to increase patient accessibility to health care organization by matching the communication channels to the patient’s profile and to change the health care organization’s communication with the patient to a highly proactive one will increase the patient’s engagement according to his or her profile. International Registered Report Identifier (IRRID): RR1-10.2196/10734

  • Climate School Combined (CSC) study logo. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/11/e11372/; License: Licensed by JMIR.

    Evaluating the Long-Term Effectiveness of School-Based Depression, Anxiety, and Substance Use Prevention Into Young Adulthood: Protocol for the Climate...

    Abstract:

    Background: Mental health and substance use disorders are the leading causes of global disability in children and youth. Both tend to first onset or escalate in adolescence and young adulthood, calling for effective prevention during this time. The Climate Schools Combined (CSC) study was the first trial of a Web-based combined universal approach, delivered through school classes, to prevent both mental health and substance use problems in adolescence. There is also limited evidence for the cost-effectiveness of school-based prevention programs. Objective: The aim of this protocol paper is to describe the CSC follow-up study, which aims to determine the long-term efficacy and cost-effectiveness of the CSC prevention program for depression, anxiety, and substance use (alcohol and cannabis use) up to 7 years post intervention. Methods: A cluster randomized controlled trial (the CSC study) was conducted with 6411 participants aged approximately 13.5 years at baseline from 2014 to 2016. Participating schools were randomized to 1 of 4 conditions: (1) control (health education as usual), (2) Climate Substance Use (universal substance use prevention), (3) Climate Mental Health (universal mental health prevention), or (4) CSC (universal substance use and mental health prevention). It was hypothesized that the CSC program would be more effective than conditions (1) to (3) in reducing alcohol and cannabis use (and related harms), anxiety, and depression symptoms as well as increasing knowledge related to alcohol, cannabis, anxiety, and depression. This long-term study will invite follow-up participants to complete 3 additional Web-based assessments at approximately 5, 6, and 7 years post baseline using multiple sources of locator information already provided to the research team. The primary outcomes include alcohol and cannabis use (and related harms) and mental health symptoms. An economic evaluation of the program will also be conducted using both data linkage as well as self-report resource use and quality of life measures. Secondary outcomes include self-efficacy, social networks, peer substance use, emotion regulation, and perfectionism. Analyses will be conducted using multilevel mixed-effects models within an intention-to-treat framework. Results: The CSC long-term follow-up study is funded from 2018 to 2022 by the Australian National Health and Medical Research Council (APP1143555). The first follow-up wave commences in August 2018, and the results are expected to be submitted for publication in 2022. Conclusions: This is the first study to provide a long-term evaluation of combined universal substance use and mental health prevention up to 7 years post intervention. Evidence of sustained benefits into early adulthood would provide a scalable, easy-to-implement prevention strategy with the potential for widespread dissemination to reduce the considerable harms, burden of disease, injury, and social costs associated with youth substance use and mental disorders. International Registered Report Identifier (IRRID): PRR1-10.2196/11372

  • Source: Unsplash; Copyright: Sai De Silva; URL: https://unsplash.com/photos/4-gFGb12hFA; License: Licensed by the authors.

    Parental Activation and Obesity-Related Health Behaviors Among a Racially and Ethnically Diverse Population of Low-Income Pediatric Patients: Protocol for a...

    Abstract:

    Background: Despite a recent decline in the obesity prevalence among preschool-aged children, obesity remains disproportionately high among children from low-income racial or ethnic minority families. Promoting healthy lifestyles (eg, obesity-preventative behaviors) in primary care settings is particularly important for young children, given the frequency of preventative health visits and parent-provider interactions. Higher adoption of specific health behaviors is correlated with increased patient activation (ie, skill, confidence, and knowledge to manage their health care) among adults. However, no published study, to date, has examined the relationship between parental activation and obesity-related health behaviors among young children. Objective: The goal of this study is to measure parental activation in low-income parents of preschoolers in 2 large health systems and to examine the association with diet, screen-time, and physical activity behaviors. Methods: We will conduct a cross-sectional study of parents of preschool-aged patients (2-5 years) receiving primary care at multiple clinic sites within 2 large health care systems. Study participants, low-income black, Hispanic, and white parents of preschool-aged patients, are being recruited across both health systems to complete orally administered surveys. Results: Recruitment began in December 2017 and is expected to end in May 2018. A total of 267 low-income parents of preschool-aged children have been enrolled across both clinic sites. We are enrolling an additional 33 parents to reach our goal sample size of 300 across both health systems. The data analysis will be completed in June 2018. Conclusions: This protocol outlines the first study to fully examine parental activation and its relationship with parent-reported diet, physical activity, and screen-time behaviors among low-income preschool-aged patients. It involves recruitment across 2 geographically distinct areas and resulting from a partnership between researchers at 2 different health systems with multiple clinical sites. This study will provide new knowledge about how parental activation can potentially be incorporated as a strategy to address childhood obesity disparities in primary care settings. International Registered Report Identifier (IRRID): RR1-10.2196/9688

  • Source: FreeDigitalPhotos.net; Copyright: Theeradech Sanin; URL: http://www.freedigitalphotos.net/images/Smoking_g375-Film_Xray_And_Cigarette_p78202.html; License: Licensed by the authors.

    Lung Function in Users of a Smoke-Free Electronic Device With HeatSticks (iQOS) Versus Smokers of Conventional Cigarettes: Protocol for a Longitudinal Cohort...

    Abstract:

    Background: Chronic obstructive pulmonary disease (COPD) is a global public health problem. It is the third-leading cause of death in the world, the fourth leading cause of death in Kazakhstan, and is strongly associated with smoking. Smoking cessation reduces the severity of respiratory symptoms and COPD exacerbations. Heated tobacco products, such as HeatSticks heated by the iQOS device, a smoke-free electronic device, may serve as less risky alternatives to conventional combustible cigarettes. Objective: The purpose of this study is to evaluate frequency of exacerbations, respiratory symptoms, physical exercise intolerance, and abnormal lung functions, as well as other parameters and comorbidities among men and women aged 40-59 residing in Almaty, Kazakhstan, who use iQOS with HeatSticks compared to smokers of conventional cigarettes. Methods: This is a 5-year single-center cohort observational study. It includes two cohorts of participants consisting of men and women aged 40-59 residing in the city of Almaty, Kazakhstan: (1) smokers of combustible cigarettes (control group) and (2) users of iQOS with HeatSticks (exposure group). The study has baseline and periodic (ie, annual) comprehensive clinical assessments, as well as continuous COPD case-finding activities and registration of acute respiratory exacerbations over the course of the 5-year observation period. Study measures include spirometry, chest computed tomography, electrocardiography, physical exams, laboratory testing of serum for biomarkers of inflammation and metabolic syndrome, anthropometry, and the 6-minute walk test. Information about COPD symptoms will be collected using the COPD Assessment Test. Results: Participant recruitment began December 2017, and enrollment is expected to last until late summer 2018. Conclusions: This is the first cohort observational study in Kazakhstan to assess differences in lung function between users of the heated tobacco product, iQOS with HeatSticks, and smokers of conventional combustible cigarettes. The study results will add to knowledge on whether switching from combustible cigarettes to iQOS with HeatSticks affects respiratory symptoms and diseases, including the development and progression of COPD. Trial Registration: ClinicalTrials.gov NCT03383601; https://clinicaltrials.gov/ct2/show/NCT03383601 (Archived by WebCite at http://www.webcitation.org/72BYoAKxa) International Registered Report Identifier (IRRID): PRR1-10.2196/10006

  • Source: pxhere; Copyright: pxhere; URL: https://pxhere.com/en/photo/860219; License: Public Domain (CC0).

    Efficacy of an Online Self-Help Treatment for Comorbid Alcohol Misuse and Emotional Problems in Young Adults: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Alcohol misuse and emotional problems (ie, depression and anxiety) are highly comorbid among Canadian young adults. However, there is a lack of integrated, accessible, and evidence-based treatment options for these young adults. Objective: The main goal of this study is to develop and test the efficacy of an integrated, online self-help program designed to target both alcohol misuse and emotional problems. Methods: A two-arm randomized controlled trial design will be used to compare the efficacy of the online integrated treatment to a psychoeducational control group. A target sample of 214 participants will be recruited and randomly assigned to either condition. The integrated treatment will last 8 weeks, and participants will work through 12 modules. Modules will incorporate content based on principles of cognitive behavioral therapy and motivational interviewing. Participants in the control group will receive links to psychoeducational resources and will have access to the full treatment after follow-up. The primary outcome will be the number of Canadian standard drinks consumed in the week leading up the assessment. Secondary outcomes of interest include symptoms of depression, anxiety, alcohol-related problems, quality of life, and use of other drugs. Assessments will be completed at 3 time-points: at baseline, at the end of treatment (ie, 8 weeks), and at follow-up (ie, 24 weeks). Upon completion, data will be analyzed using generalized linear mixed models. Results: Data collection began in June 2018 and will continue until January 2020. Final study results will be submitted for publication by July 2020. Conclusions: Currently, there are no integrated treatments designed to target alcohol misuse and the range of emotional problems experienced by young adults. This research stands to provide an effective, accessible (ie, Web-based), and feasible option to treat the many struggling young adults in this country. Trial Registration: ClinicalTrials.gov ID NCT03406039; https://clinicaltrials.gov/ct2/show/NCT03406039 (Archived by WebCite at http://www.webcitation.org/72fDefnrh) Registered Report Identifier: PRR1-10.2196/11298

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/10/e10491/; License: Public Domain (CC0).

    Perioperative Optimization With Nutritional Supplements in Patients Undergoing Gastrointestinal Surgery for Cancer (PROGRESS): Protocol for a Feasibility...

    Abstract:

    Background: Postoperative morbidity following gastrointestinal tract major surgery ranges between 40% and 60%. Malnutrition, poor protein intake, and surgery-related impairment of the immune system and its function have been associated with postoperative infections. Supplemental perioperative nutrition may improve nutrition by increasing protein intake to influence cell-mediated immunity, thereby reducing the rate of postoperative infectious complications. Objective: The primary objective of our trial is to determine the proportion of eligible patients randomized in an 18-month period. The primary feasibility outcome will be to (1) stop, main study not feasible: estimated proportion of randomized patients <40.0% (40/100); (2) continue with protocol modifications: estimated proportion of randomized patients 40.0% (40/100) to 59.0% (50/100); or (3) continue without modification: estimated proportion of randomized patients ≥60.0% (60/100). The secondary objectives are to evaluate compliance with the nutritional supplements and to estimate differences in postoperative complications, global health-related quality of life (QoL), and median length of hospital stay between the groups. Methods: This is a double-blind randomized placebo-controlled feasibility trial. The intervention comprises three nutritional supplements: a protein isolate powder (ISOlution); immunomodulation (INergy-FLD), formulated liquid diet; and carbohydrate loading (PreCovery). Patients will consume 1 serving of the protein supplement per day from the randomization time up to 6 days before surgery (30 days in total). The immunomodulation, a solution that contains arginine, protein isolate, omega-6 fatty acids, and RNA, aims to attenuate excessive inflammatory responses and to replenish nutrients. This solution will be consumed as 3 doses per day for 5 days before and after surgery. Carbohydrate loading helps to reduce the stress from surgery by decreasing insulin resistance. Patients will have 2 servings the evening before surgery and 1 serving 2-3 hours before surgery. To be eligible, patients must have a resectable gastrointestinal cancer for which an elective operation is planned. Patients will be stratified according to nutritional status. The operation should occur within 4 weeks from enrollment. Results: We expect to screen 165 eligible patients; 60.6% (100/165) of them will be randomized to either intervention or placebo. Assuming a two-sided alpha of .05, this will give us a 95% CI around the estimate of 53%-68%. A sample size of 50 per group will enable us to estimate the treatment effect and corresponding variance of the complication rate and QoL measures with adequate precision. The success is defined as the proportion of eligible patients randomized as ≥60.0% (60/100). Patients’ compliance is defined as an intake of at least 70% (41/58) sachets of the intervention volume. Conclusions: The results will help to determine the feasibility of a larger randomized controlled trial to implement a perioperative nutritional supplement program for patients undergoing gastrointestinal surgery for cancer. Trial Registration: ClinicalTrials.gov NCT03445260; https://clinicaltrials.gov/ct2/show/NCT03445260 (Archived by WebCite at http://www.webcitation.org/72CAmMzgP) International Registered Report Identifier (IRRID): PRR1-10.2196/10491

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/10/e11278/; License: Creative Commons Attribution (CC-BY).

    Co-Designing an eHealth Service for the Co-Care of Parkinson Disease: Explorative Study of Values and Challenges

    Abstract:

    Background: The need for services to support patient self-care and patient education has been emphasized for patients with chronic conditions. People with chronic conditions may spend many hours per year in health and social care services, but the majority of time is spent in self-care. This has implications in how health care is best organized. The term co-care specifically stresses the combination of health care professionals’ and patients’ resources, supported by appropriate (digital) tools for information exchange, to achieve the best possible health outcomes for patients. Developers of electronic health (eHealth) services need to consider both parties’ specific needs for the service to be successful. Research on participants’ experiences of participating in co-design sessions is scarce. Objective: The aim of this study was to describe different stakeholders’ (people with chronic conditions, health care professionals, and facilitators) overall experiences of participating in co-design workshops aimed at designing an eHealth service for co-care for Parkinson disease, with a particular focus on the perceptions of values and challenges of co-design as well as improvement suggestions. Methods: We conducted 4 half-day co-design workshops with 7 people with Parkinson disease and 9 health care professionals. Data were collected during the workshop series using formative evaluations with participants and facilitators after each workshop, researchers’ diary notes throughout the co-design process, and a Web-based questionnaire after the final workshop. Quantitative data from the questionnaire were analyzed using descriptive statistics. Qualitative data were triangulated and analyzed inductively using qualitative content analysis. Results: Quantitative ratings showed that most participants had a positive general experience of the co-design workshops. Qualitative analysis resulted in 6 categories and 30 subcategories describing respondents’ perceptions of the values and challenges of co-design and their improvement suggestions. The categories concerned (1) desire for more stakeholder variation; (2) imbalance in the collaboration between stakeholders; (3) time investment and commitment paradox; (4) desire for both flexibility and guidance; (5) relevant workshop content, but concerns about goal achievement; and (6) hopes and doubts about future care. Conclusions: Based on the identified values and challenges, some paradoxical experiences were revealed, including (1) a desire to involve more stakeholders in co-design, while preferring to work in separate groups; (2) a desire for more preparation and discussions, while the required time investment was a concern; and (3) the experience that co-design is valuable for improving care, while there are doubts about the realization of co-care in practice. The value of co-design is not mainly about creating new services; it is about improving current practices to shape better care. The choice of methods needs to be adjusted to the stakeholder group and context, which will influence how they experience the process and outcomes of co-design.

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    Open Peer Review Period: Nov 12, 2018 - Nov 26, 2018

    Background: Childhood obesity is a pervasive and challenging public health issue, with 30% of children aged 2-4 years classified as being overweight or obese in New Zealand. This is concerning, given...

    Background: Childhood obesity is a pervasive and challenging public health issue, with 30% of children aged 2-4 years classified as being overweight or obese in New Zealand. This is concerning, given that up to 90% of obese 3-year-old children are overweight or obese by the time they reach adolescence. Interventions that specifically target this age range often fail to demonstrate long-term effectiveness, and primarily focus on traditional weight-related behaviours, including diet, physical activity, and sedentary behaviour. However, recent research suggests that targeting non-traditional weight-related behaviours, such as sleep, screen time, and family meals, may be appropriate and more effective approach in this age group, given the immense challenges in changing traditional weight-related behaviours long-term. Objective: The aim of the proposed study was to develop and pilot the 3 Pillars Study (3PS), a 6-week program for parents of New Zealand toddlers and preschoolers aged 2-4 years to promote positive parent-child interactions during three family routines, specifically, adequate sleep, regular family meals, and restricted screen time. Methods: The effects of the program on screen time (primary endpoint), frequency of family meals, parent feeding practices, diet quality, and sleep duration will be piloted using a randomized controlled trial, with outcomes compared between the active intervention group and a wait-list control group at 6 weeks (at the end of the programme) and 12 weeks (at final follow-up). We aim to recruit 50 participants (25 per arm). Eligibility criteria include parents of children aged 2-4 years of age who are currently exceeding screen use recommendations (that is, greater than 1 hour of screen time per day). The 3PS program involves a half-day workshop, run by a community worker trained to deliver the program content, and 6-week access to a study website that contains in-depth information about the program. All participants will also receive a study pack, which includes resources to encourage engagement in the three family routines promoted by the program. Study data will be collected in REDCap. All statistical analyses will be performed using SAS version 9.4, and have been specified a priori in a statistical analysis plan prepared by the study statistician. Results: Trial recruitment opened in July 2018. Final follow-up is expected in December 2018, with trial findings expected to be available in early 2019. Conclusions: Findings from this pilot study will provide relevant data to inform the design of a larger effectiveness study of the 3PS program. Clinical Trial: Australia New Zealand Clinical Trials Register ACTRN12618000823279

  • Policies and programs for the prevention and control of breast cancer in Mexican and Central American women: protocol for a scoping review

    Date Submitted: Nov 10, 2018

    Open Peer Review Period: Nov 10, 2018 - Nov 24, 2018

    Background: Breast cancer has become one of the main public health problems all around the world, especially in Central America and Mexico. Self-exploration and early diagnosis are the best ways to lo...

    Background: Breast cancer has become one of the main public health problems all around the world, especially in Central America and Mexico. Self-exploration and early diagnosis are the best ways to look after this type of cancer. In Mexico and Central America, as in many other countries, breast cancer prevention and control activities are performed permanently; but, there are no comprehensive public reports that could provide information on the policies that originated the programs, the number, type, and scope of these activities as well as the impact of the performed programs and actions. Objective: Therefore, this document’s goal is to present the design of a Scoping Review protocol about the policies and action programs for breast cancer care in Mexico and Central America, as well as its objectives and implementation plan. Methods: This Scoping Review protocol was developed on the basis of the methodological reference framework of Arksey and O’Malley (2005). A systematic search of the following electronic databases will be performed: MEDLINE (PubMed), MEDLINE (EbscoHost), CINAHL (EbscoHost), Academic Search Complete (EbscoHost), ERIC, ISI Web of Science (Science Citation Index) in English, Cochrane, and MEDES-MEDicina in Spanish. The time scope of the search will be from 2000 trough 2018. Results: Since the data will not be obtained from primary sources, the approval of an ethics and research committee is not necessary. Data will be analyzed and presented in descriptive statistics and qualitative content analyses with analysis matrixes and semantic networks. The intention is to present the results to health authorities, conferences and publish them in an indexed journal. Conclusions: According to this proposal, we present a protocol for a Scoping Review-type literature revision based on the Arksey and O’Malley (2005) methodology during the first semester of 2019. According to this five-stage methodology, we will identify the scientific publications that present or analyze first-level action policies and programs for Breast Cancer care in Mexican women, as well as their results, if any. The outcome of this review will be used to define the bases of a research project intended to design an educational intervention strategy for the general public in Mexico, in order to deal with this important public health problem.

  • Integrating PrEP into Family Planning Services at Title X Clinics in the Southeastern US – Phase 1 (ATN 155)

    Date Submitted: Nov 8, 2018

    Open Peer Review Period: Nov 9, 2018 - Nov 23, 2018

    Background: Black adolescent and young adult women (AYAW) in the Southern United States (US) are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individu...

    Background: Black adolescent and young adult women (AYAW) in the Southern United States (US) are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to health services that AYAW already trust, access routinely, and deem useful for their sexual health offers an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. These services include those of family planning (FP) providers in high HIV incidence settings. However, PrEP has not been widely integrated into FP services, including Title X-funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern US are uniquely positioned to be focal sites for conceptually-informed and thoroughly-evaluated PrEP implementation science studies. Objective: Assess inner and outer context factors (barriers and facilitators) that may influence the adoption of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern US. Methods: Phase 1 of Planning4PrEP is an explanatory sequential, mixed methods study consisting of a geographically-targeted online survey of Title X clinic administrators and providers in the Southern US, followed by key informant interviews (KIIs) among a purposively-selected subset of responders to more comprehensively access inner and outer context factors that may influence adoption and implementation of PrEP in Title X FP clinics in the South. Results: Phase 1 of Planning4PrEP research activities began in October 2017and are ongoing. To date, survey and KII administration is near completion with quantitative and qualitative data analysis scheduled to begin soon after data collection completion Conclusions: This study seeks to assess inner and outer contextual factors (barriers and facilitators) that may influence the adoption and integration of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern US.

  • Utilizing Biomarker Feedback Documenting Child Exposure to Tobacco Toxins to Promote Smoke-Free Homes: Study Protocol for a Randomized Clinical Trial

    Date Submitted: Oct 30, 2018

    Open Peer Review Period: Nov 3, 2018 - Dec 29, 2018

    Background: Background: Exposure to second-hand smoke (SHS) early in life increases the risk of SIDS, asthma and respiratory illnesses. Since children’s primary exposure to SHS occurs in the home,...

    Background: Background: Exposure to second-hand smoke (SHS) early in life increases the risk of SIDS, asthma and respiratory illnesses. Since children’s primary exposure to SHS occurs in the home, these most vulnerable members of our society are not fully protected by recent increases in the adoption of smoking bans in public spaces. Although exposure to SHS is a readily addressed cause of excess morbidity, few low-income homes strictly enforce smoking restrictions. Objective: Objective: To test a novel approach to motivate the adoption of home smoking restrictions (HSR) and to eliminate child SHS exposure by providing parents with objective, biomarker documentation of child exposure to tobacco toxins. Methods: Methods: From 2011 to 2013, 195 low-income, female smokers with children ≤ 10 years old, residing in their homes were recruited into a two-arm randomized clinical trial. Participants were assigned to one of two groups: Biomarker Feedback (n = 98) vs. Health Education, (n = 97). In-home assessments were administered at baseline, week 16 and week 26. Child urine nicotine, cotinine and NNAL (a metabolite of the known tobacco carcinogen, NNK), an objective measure of home SHS exposure (i.e., passive nicotine dosimeter) and a surface sample of residual (ie, third-hand) tobacco smoke were collected at all three time points. Primary outcome was dosimeter-verified, complete home smoking restrictions at 6-months post-randomization. Secondary outcomes included parental self report of smoking behavior change and child urine biomarker change. Results: Results : Data collection and analyses are complete and results are being interpreted. Conclusions: Discussion: The study protocol describes the development of a novel community-based controlled trial designed to examine the efficacy of biomarker feedback documenting a child’s exposure to enviornmental tobacco smoke on parental smoking behavior change. Clinical Trial: Trial Registration: ClinicalTrials.gov Identifier: NCT01574560

  • Family in Rehabilitation, EmpowERing carers for improved malnutrition outcomes: Study protocol for the FREER Pilot Study

    Date Submitted: Oct 30, 2018

    Open Peer Review Period: Nov 3, 2018 - Nov 17, 2018

    Background: Interventions to improve the nutritional status of older adults and the integration of formal and family care systems are critical research areas to improve the independence and health of...

    Background: Interventions to improve the nutritional status of older adults and the integration of formal and family care systems are critical research areas to improve the independence and health of ageing communities; and are particularly relevant in the rehabilitation setting. Objective: In malnourished older adults, does the FREER intervention during and post-rehabilitation improve nutritional status, physical function, quality of life, service satisfaction, and hospital and aged care admission rates up to 3-months post-discharge, compared with usual care? Secondary outcomes evaluated include family carer burden, carer services satisfaction, and patient and carer experiences. This pilot study will also evaluate feasibility and intervention fidelity to inform a larger randomised controlled trial. Methods: This is the protocol for a mixed-methods two-arm historically-controlled prospective pilot intervention study. The historical control group has 30 participants, and the pilot intervention group aims to recruit 30 patient-carer pairs. The FREER intervention delivers nutrition counselling during rehabilitation, 3-months of post-discharge telehealth follow-up, and provides supportive resources using a novel model of patient-centred and carer-centred nutrition care. The primary outcome is nutritional status measured by the Scored Patient-Generated Subjective Global Assessment score. Qualitative outcomes such as experiences and perceptions of value will be measured using semi-structured interviews followed by thematic analysis. The process evaluation addresses intervention fidelity and feasibility. Results: Recruitment commenced on the 4th July 2018 and is ongoing, with eight patient-carer pairs recruited at the time of manuscript submission. Conclusions: This research will inform a larger randomised controlled trial, with potential for translation to health service policies and new models of dietetic care to support the optimisation of nutritional status across a continuum of nutrition care from rehabilitation to home. Clinical Trial: Australian New Zealand Clinical Trials Registry (Trial ID: ACTRN12618000338268).

  • Healthy Stores 2020: Reducing retail merchandising of discretionary food and beverages in remote Indigenous community stores: Study protocol

    Date Submitted: Oct 31, 2018

    Open Peer Review Period: Nov 3, 2018 - Nov 17, 2018

    Background: Discretionary food and beverages (products high in high in saturated fat, added sugars and salt) are detrimental to a healthy diet. Nevertheless, they provide 42% of total energy and accou...

    Background: Discretionary food and beverages (products high in high in saturated fat, added sugars and salt) are detrimental to a healthy diet. Nevertheless, they provide 42% of total energy and account for 53% of food and beverage expenditure for remote living Aboriginal and Torres Strait Islander Australians, contributing to the excessive burden of chronic disease experienced by this population group. Objective: In collaboration with the Arnhem Land Progress Aboriginal Corporation (ALPA; which operates 25 stores in very remote Australia) we will test an intervention to reduce sales of discretionary products, by reducing their merchandising and substituting core products, in remote Australian communities. Methods: We will use a community-level randomised controlled pragmatic trial design. Stores randomised to the intervention group will be supported by ALPA to reduce merchandising of four food categories (sugar, sugar sweetened beverages, sweet biscuits and confectionery) that in total provide 64% of total energy from discretionary foods and 87% of total free sugars in very remote community stores. The remaining stores (50% of total) will serve as controls and conduct business as usual. Electronic store sales data will be collected at baseline, 12-weeks intervention and 24-weeks post intervention to objectively assess the primary outcome of percent change in purchases of free sugars (g/MJ) and secondary business- and diet-related outcomes. Critical to ensuring translation to improved store policies and healthier diets in remote Indigenous Australia we will conduct i) an in-depth implementation evaluation to assess fidelity; ii) a customer intercept survey to investigate the relationship between customer characteristics and discretionary food purchasing; and iii) a qualitative study to identify policy supports for scale-up of health enabling policy action in stores. Results: No results given as it is a protocol paper Conclusions: Novel pragmatic research approaches are needed to inform policy for healthy retail food environments. This research will greatly advance our understanding of how the retail food environment can be used to improve population level diet in the remote Australian Aboriginal and Torres Strait Islander context and retail settings globally. Clinical Trial: ACTRN 12618001588280

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