JMIR Publications

JMIR Research Protocols

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

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Journal Description

 

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

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

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

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

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

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

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

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

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

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

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

 
 

Recent Articles:

  • Source: Pixabay; Copyright: holiho; URL: https://pixabay.com/en/sport-nordic-walking-park-fitness-2863541/; License: Public Domain (CC0).

    An eHealth Intervention to Promote Physical Activity and Social Network of Single, Chronically Impaired Older Adults: Adaptation of an Existing Intervention...

    Abstract:

    Background: Especially for single older adults with chronic diseases, physical inactivity and a poor social network are regarded as serious threats to their health and independence. The Active Plus intervention is an automated computer-tailored eHealth intervention that has been proven effective to promote physical activity (PA) in the general population of adults older than 50 years. Objective: The aim of this study was to report on the methods and results of the systematic adaptation of Active Plus to the wishes and needs of the subgroup of single people older than 65 years who have one or more chronic diseases, as this specific target population may encounter specific challenges regarding PA and social network. Methods: The Intervention Mapping (IM) protocol was used to systematically adapt the existing intervention to optimally suit this specific target population. A literature study was performed, and quantitative as well as qualitative data were derived from health care professionals (by questionnaires, n=10) and the target population (by focus group interviews, n=14), which were then systematically integrated into the adapted intervention. Results: As the health problems and the targeted behavior are largely the same in the original and adapted intervention, the outcome of the needs assessment was that the performance objectives remained the same. As found in the literature study and in data derived from health professionals and focus groups, the relative importance and operationalization of the relevant psychosocial determinants related to these objectives are different from the original intervention, resulting in a refinement of the change objectives to optimally fit the specific target population. This refinement also resulted in changes in the practical applications, program components, intervention materials, and the evaluation and implementation strategy for the subgroup of single, chronically impaired older adults. Conclusions: This study demonstrates that the adaptation of an existing intervention is an intensive process in which adopting the IM protocol is an invaluable tool. The study provides a broad insight in adapting interventions aimed at single older adults with a chronic disease. It is concluded that even when the new target population is a sizable segment of the original target population, the adapted intervention still needs considerable changes to optimally fit the needs and situational differences of the narrower target population.

  • Source: Universal Medicine; Copyright: Iris Pohl; URL: http://www.researchprotocols.org/2017/11/e234/; License: Creative Commons Attribution + NoDerivatives (CC-BY-ND).

    A Group of 500 Women Whose Health May Depart Notably From the Norm: Protocol for a Cross-Sectional Survey

    Abstract:

    Background: Longitudinal studies of women’s health often seek to identify predictors of good health. Research has shown that following simple guidelines can halve women’s mortality. The ongoing Australian Longitudinal Study of Women’s Health (ALSWH) shows that Australian women are getting better at reducing their smoking and alcohol use, and are generally diligent about attending recommended health screenings, but are becoming less successful at dealing with obesity. There are communities of women who live unusually healthy lives (Rosetans, Seventh-Day Adventists, traditional Japanese women), but their lifestyles are unlikely to be adopted widely. Universal Medicine (UM) is a complementary-to-medicine approach that emphasizes personal empowerment and the importance of menstrual health symptoms. Objective: This survey investigates whether the approximately 500 women associated with UM exhibit health status significantly above the norm. As part of this investigation, questions for a newly developed menstrual attitudes questionnaire will also be evaluated. Methods: A quantitative cross-sectional survey of women in a UM cohort was designed with the help of three focus groups of women at three life stages: in menses, peri-menopausal, and menopausal. The menstrual attitudes portion of the survey incorporates the insights of these women regarding female health issues. The survey also includes 41 questions taken from the ALSWH. Focus groups generated additional questions about symptoms experienced and attitudes toward female health issues. ALSWH questions, including a range of health scales like the Short Form 36 (SF-36), Center for Epidemiologic Studies Depression Scale, Perceived Control Scale, Kessler Psychological Distress Scale, and the Multi-Item Summed Score for Perceived Stress, along with questions about experienced major health events, were investigated and incorporated if considered suitable. Results: The validity of the menstrual attitudes questionnaire will be evaluated with Cohen’s kappa. ALSWH respondents and UM participants will be compared, using unweighted regression or regression weighted or normalized by age, education, and interest in alternative treatments (to increase comparability), as appropriate. Analyses will determine whether UM-related variables (being a UM participant, length of UM participation, number of UM events attended) are associated with: differences in the number of major health events and health symptoms experienced; SF-36 physical and mental health scores; body mass index; and consumption of alcohol, tobacco, sugar, salt, caffeine, and dairy. Conclusions: If women in the UM cohort are truly in substantially better health than the norm, further investigations may be worthwhile to see whether UM plays a causal role, and whether the women’s practices are generalizable.

  • Source: Pexels; Copyright: Yury Kim; URL: https://www.pexels.com/photo/build-builder-construction-equipment-585419/; License: Public Domain (CC0).

    The Effect of Aging on Physical Performance Among Elderly Manual Workers: Protocol of a Cross-Sectional Study

    Abstract:

    Background: In 2012, the Danish Parliament decided to increase retirement age. Unfortunately, elderly people working in a physically demanding environment may be rendered unable to retain the ability to adequately perform the physical requirements of their jobs, due to age-related decreases in physical performance. Therefore, increasing the retirement age may not necessarily lead to the goal of keeping everybody in the labor market for a longer time. To date, our knowledge about the variations in physical performance of the elderly workforce is limited. Objective: In this cross-sectional study we seek to investigate the effects of aging on physical performance among elderly manual workers. Methods: Approximately 100 Danish manual workers between 50 and 70 years of age will be recruited. The main measurement outcomes include: (1) inflammatory status from blood samples; (2) body composition; (3) lung function; (4) static and dynamic balance; (5) reaction time, precision, and movement variability during a hammering task; (6) handgrip strength, rate of force development, and force tracking; (7) estimated maximal rate of oxygen consumption; and (8) back mobility. Additionally, information regarding working conditions, physical activity levels, and health status will be assessed with a questionnaire. Results: Data collection is expected to take place between autumn 2017 and spring 2018. Conclusions: This study will increase the knowledge regarding variations in physical performance in the elderly workforce and may identify potential workplace hazards. Moreover, this study might shed light on the potentially problematic decision to increase retirement age for all Danish citizens.

  • Dry needling of the upper trapezius. Source: Image created by the Authors; Copyright: Eric Gattie; URL: http://www.researchprotocols.org/2017/11/e227/; License: Creative Commons Attribution (CC-BY).

    Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial

    Abstract:

    Background: Neck pain is a costly and common problem. Current treatments are not adequately effective for a large proportion of patients who continue to experience recurrent pain. Therefore, new treatment strategies should be investigated in an attempt to reduce the disability and high costs associated with neck pain. Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues, and muscle with the intent to mechanically disrupt tissue without the use of an anesthetic. Dry needling is emerging as a treatment modality that is widely used clinically to address a variety of musculoskeletal conditions. Recent studies of dry needling in mechanical neck pain suggest potential benefits, but do not utilize methods typical to clinical practice and lack long-term follow-up. Therefore, a clinical trial with realistic treatment time frames and methods consistent with clinical practice is needed to examine the effectiveness of dry needling on reducing pain and enhancing function in patients presenting to physical therapy with mechanical neck pain. Objective: The aim of this trial will be to examine the short- and long-term effectiveness of dry needling delivered by a physical therapist on pain, disability, and patient-perceived improvements in patients with mechanical neck pain. Methods: We will conduct a randomized, double-blind, placebo-controlled trial in accordance with the CONSORT guidelines. A total of 76 patients over the age of 18 with acute or chronic mechanical neck pain resulting from postural dysfunction, trauma, or insidious onset who are referred to physical therapy will be enrolled after meeting the eligibility criteria. Subjects will be excluded if they have previous history of surgery, whiplash in the last 6 weeks, nerve root compression, red flags, or contraindications to dry needling or manual therapy. Participants will be randomized to receive (1) dry needling, manual therapy, and exercise or (2) sham dry needling, manual therapy, and exercise. Participants will receive seven physical therapy treatments lasting 45 minutes each over a maximum of 4 weeks. The primary outcome will be disability as measured by the Neck Disability Index. Secondary outcomes include the following: pain, patient-perceived improvement, patient expectations, and successful blinding to the needling intervention. Outcome measures will be assessed at 4 weeks, 6 months, and 12 months by an assessor who is blind to the group allocation of the participants to determine the short- and long-term treatment effects. We will examine the primary aim with a two-way, repeated-measures analysis of variance with treatment group as the between-subjects variable and time as the within-subjects variable. The hypothesis of interest will be the two-way group by time interaction. An a priori alpha level of .05 will be used for all analyses. Results: Recruitment is currently underway and is expected to be completed by the end of 2017. Data collection for long-term outcomes will occur throughout 2017 and 2018. Data analysis, preparation, and publication submission is expected to occur throughout the final three quarters of 2018. Conclusions: The successful completion of this trial will provide evidence to demonstrate whether dry needling is effective for the management of mechanical neck pain when used in a combined treatment approach, as is the common clinical practice. Trial Registration: ClinicalTrials.gov NCT02731014; https://clinicaltrials.gov/ct2/show/NCT02731014 (Archived by WebCite at http://www.webcitation.org/6ujZgbhsq)

  • Medly app. Source: Centre for Global eHealth Innovation; Copyright: The Authors; License: Creative Commons Attribution (CC-BY).

    Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized...

    Abstract:

    Background: The rising prevalence of chronic illnesses hinders the sustainability of the health care system because of the high cost of frequent hospitalizations of patients with complex chronic conditions. Clinical trials have demonstrated that telemonitoring can improve health outcomes, but they have generally been limited to single conditions such as diabetes, hypertension, or heart failure. Few studies have examined the impact of telemonitoring on complex patients with multiple chronic conditions, although these patients may benefit the most from this technology. Objective: The aim of this study is to investigate the impact of a smartphone-based telemonitoring system on the clinical care and health outcomes of complex patients across several chronic conditions. Methods: A mixed-methods, 6-month randomized controlled trial (RCT) of a smartphone-based telemonitoring system is being conducted in specialty clinics. The study will include patients who have been diagnosed with one or more of any of the following conditions: heart failure, chronic obstructive pulmonary disease, chronic kidney disease, uncontrolled hypertension, or insulin-requiring diabetes. The primary outcome will be the health status of patients as measured with SF-36. Patients will be randomly assigned to either the control group receiving usual care (n=73) or the group using the smartphone-based telemonitoring system in addition to usual care (n=73). Results: Participants are currently being recruited for the trial. Data collection is anticipated to be completed by the fall of 2018. Conclusions: This RCT will be among the first trials to provide evidence of the impact of telemonitoring on costs and health outcomes of complex patients who may have multiple chronic conditions. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 41238563; http://www.isrctn.com/ISRCTN41238563 (Archived by WebCite at http://www.webcitation.org/6ug2Sk0af) and Clinicaltrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852 (Archived by WebCite at http://www.webcitation.org/6uvjNosBC)

  • Child with broken elbow. Source: iStock by Getty Images; Copyright: Twin Design; URL: https://www.shutterstock.com/image-photo/little-boy-hospital-broken-arm-back-147937385?irgwc=1&utm_medium=Affiliate&utm_campaign=TinEye&utm_source=77643&utm_term=; License: Licensed by the authors.

    Surgical Interventions for the Treatment of Supracondylar Humerus Fractures in Children: Protocol of a Systematic Review

    Abstract:

    Background: The treatment of supracondylar humerus fracture in children (SHFC) is associated with complications such as functional deficit, residual deformity, and iatrogenic neurological damage. The standard treatment is closed reduction and percutaneous Kirschner wire fixation with different configurations. Despite this fact, there is still no consensus on the most effective technique for the treatment of these fractures. Objective: The aim of this systematic review will be to evaluate the effect of surgical interventions on the treatment of Gartland type II and III SHFC by assessing function, complications, and error as primary outcomes. Clinical outcomes such as range of motion and pain and radiographic outcomes will also be judged. Methods: A systematic review of randomized controlled trials or quasi-randomized controlled trials evaluating the surgical treatment of SHFC will be carried out in the Cochrane Central Register of Controlled Trials, PubMed, Literatura Latino-Americana e do Caribe em Ciências da Saúde, and Excerpta Medica Database. The search will also occur at ongoing and recently completed clinical trials in selected databases. Data management and extraction will be performed using a data withdrawal form and by analyzing the following: study method characteristics, participant characteristics, intervention characteristics, results, methodological domains, and risk of bias. To assess the risk of bias of the included trials, the Cochrane Risk of Bias Tool will be used. Dichotomous outcome data will be analyzed as risk ratios, and continuous outcome data will be expressed as mean differences, both with 95% confidence intervals. Also, whenever possible, subgroup analysis, sensitivity analysis, and assessment of heterogeneity will be performed. Results: Following the publication of this protocol, searches will be run and included studies will be deeply analyzed. We hope to obtain final results in the next few months and have the final paper published by the end of 2018. This study was funded by a government-based noncommercial agency, Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP). Conclusions: This study may provide surgical treatment effects evidence for SHFC. The results will assist clinical practice by demonstrating the effectiveness and potential complications of these interventions and might serve as a reference for future clinical trials on the topic. Trial Registration: PROSPERO CRD42014009304; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=9304 (Archived by WebCite at http://www.webcitation.org/6usiDHzD7)

  • Source: Max Pixel; Copyright: FreeGreatPicture.com; URL: http://maxpixel.freegreatpicture.com/Walker-Lame-Human-Seniorin-Old-Woman-Seniors-874979; License: Public Domain (CC0).

    Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. A growing body of evidence shows that individuals with COPD have important deficits in balance control that may be associated with an increased risk of falls. Pulmonary rehabilitation (PR) is a key therapeutic intervention for individuals with COPD; however, current international guidelines do not include balance training and fall prevention strategies. Objective: The primary aim of this trial is to determine the effects of PR with balance training compared to PR with no balance training on the 12-month rate of falls in individuals with COPD. Secondary aims are to determine the effects of the intervention on balance, balance confidence, and functional lower body strength, and to estimate the cost-effectiveness of the program. Methods: A total of 400 individuals from nine PR centers across Canada, Europe, and Australia will be recruited to participate in a randomized controlled trial. Individuals with COPD who have a self-reported decline in balance, a fall in the last 2 years, or recent near fall will be randomly assigned to an intervention or control group. The intervention group will undergo tailored balance training in addition to PR and will receive a personalized home-based balance program. The control group will receive usual PR and a home program that does not include balance training. All participants will receive monthly phone calls to provide support and collect health care utilization and loss of productivity data. Both groups will receive home visits at 3, 6, and 9 months to ensure proper technique and progression of home exercise programs. The primary outcome will be incidence of falls at 12-month follow-up. Falls will be measured using a standardized definition and recorded using monthly self-report fall diary calendars. Participants will be asked to record falls and time spent performing their home exercise program on the fall diary calendars. Completed calendars will be returned to the research centers in prepaid envelopes each month. Secondary measures collected by a blinded assessor at baseline (pre-PR), post-PR, and 12-month follow-up will include clinical measures of balance, balance confidence, functional lower body strength, and health status. The cost-effectiveness of the intervention group compared with the control group will be evaluated using the incremental cost per number of falls averted and the incremental cost per quality-adjusted life years gained. Results: Recruitment for the study began in January 2017 and is anticipated to be complete by December 2019. Results are expected to be available in 2020. Conclusions: Findings from this study will improve our understanding of the effectiveness and resource uses of tailored balance training for reducing falls in individuals with COPD. If effective, the intervention represents an opportunity to inform international guidelines and health policy for PR in individuals with COPD who are at risk of falling. Trial Registration: ClinicalTrials.gov NCT02995681; https://clinicaltrials.gov/ct2/show/NCT02995681 (Archived by WebCite at http://www.webcitation.org/6ukhxgAsg)

  • Source: Pixabay; Copyright: jarmoluk; URL: https://pixabay.com/en/laboratory-analysis-diagnostics-2815641/; License: Public Domain (CC0).

    Immune-Enhancing Formulas for Patients With Cancer Undergoing Esophagectomy: Systematic Review Protocol

    Abstract:

    Background: Adult patients with an esophageal cancer can potentially be compromised with postoperative leaks or fistulae if patients’ nutritional status is in a vulnerable stage. Currently in Australia, there is a growing need for clinicians to know whether use of immune-enhancing formulas (IEFs) containing Arg, omega-3, and RNA are a cost-effective approach compared with isonitrogenous-isocaloric formulas to reduce postoperative infectious complications in esophagectomy patients. Since IEFs may carry higher costs, this has led to inconsistencies in practice among clinicians and hospitals. Objective: Our aim is to compile and present the most up-to-date nutrition evidence available regarding the provision of IEFs containing Arg, omega-3, and RNA to help clinicians develop an evidence-based nutrition care plan; identify available evidence of whether an esophagectomy patient should receive IEF; determine the cost-effectiveness and safety of such nutrition; and determine appropriate administration quantity and timing (pre-, peri-, or postesophagectomy). Methods: This review will include RCTs involving the use of IEFs enriched with Arg, omega-3 polyunsaturated fatty acids, and RNA in the pre-, peri-, or postoperative period (for at least 5-7 days) given orally or via enteral feeding tube, in adult cancer patients undergoing esophageal resection. Lower gastrointestinal, gastric, or head cancer surgery with parenteral nutrition or non-IEF or use of isolated immunonutrient (Arg vs omega-3 vs RNA) will be excluded. Primary outcome comprises postoperative infectious complications. Secondary outcomes (pre/postoperatively) consist of cost-effectiveness, length of stay, survival/mortality, quality of life, nutritional status, percentage of weight loss, and biochemical changes. The risk of bias will be independently assessed by the reviewers, using a domain-based evaluation tool. Blinding will be assessed for subjective and objective outcome measures. Publication bias will be visually assessed by funnel plots. A meta-analysis will be generated by the Review Manager 5.3 software and represented in forest plots. Results: The first results are expected in 2018. Outlining the protocol will ensure transparency for the completed review. Conclusions: This protocol for a systematic review and meta-analysis will enable a comprehensive appraisal of the literature to help determine whether overall institutional savings are associated with this approach. Findings will form a knowledge base relevant to stakeholders across the health system and researchers who are involved in decision making on evidence-based nutrition care plan pathways for patients undergoing esophagectomy, as well as the use of IEF, timing, and administration quantity. Trial Registration: PROSPERO Registration Number: CRD42017056908; http://www.crd.york.ac.uk/PROSPERO/ display_record.asp? ID=CRD42017056908 (Archived by WebCite at http://www.webcitation.org/6rLyeqaD6)

  • Source: Shutterstock; Copyright: takasu; URL: https://www.shutterstock.com/image-photo/doctor-explaining-patient-406647739; License: Licensed by the authors.

    Development and Usability Testing of a Computer-Tailored Decision Support Tool for Lung Cancer Screening: Study Protocol

    Abstract:

    Background: Awareness of lung cancer screening remains low in the screening-eligible population, and when patients visit their clinician never having heard of lung cancer screening, engaging in shared decision making to arrive at an informed decision can be a challenge. Therefore, methods to effectively support both patients and clinicians to engage in these important discussions are essential. To facilitate shared decision making about lung cancer screening, effective methods to prepare patients to have these important discussions with their clinician are needed. Objective: Our objective is to develop a computer-tailored decision support tool that meets the certification criteria of the International Patient Decision Aid Standards instrument version 4.0 that will support shared decision making in lung cancer screening decisions. Methods: Using a 3-phase process, we will develop and test a prototype of a computer-tailored decision support tool in a sample of lung cancer screening-eligible individuals. In phase I, we assembled a community advisory board comprising 10 screening-eligible individuals to develop the prototype. In phase II, we recruited a sample of 13 screening-eligible individuals to test the prototype for usability, acceptability, and satisfaction. In phase III, we are conducting a pilot randomized controlled trial (RCT) with 60 screening-eligible participants who have never been screened for lung cancer. Outcomes tested include lung cancer and screening knowledge, lung cancer screening health beliefs (perceived risk, perceived benefits, perceived barriers, and self-efficacy), perception of being prepared to engage in a patient-clinician discussion about lung cancer screening, occurrence of a patient-clinician discussion about lung cancer screening, and stage of adoption for lung cancer screening. Results: Phases I and II are complete. Phase III is underway. As of July 15, 2017, 60 participants have been enrolled into the study, and have completed the baseline survey, intervention, and first follow-up survey. We expect to have results by December 31, 2017 and to have data analysis completed by March 1, 2018. Conclusions: Results from usability testing indicate that the computer-tailored decision support tool is easy to use, is helpful, and provides a satisfactory experience for the user. At the conclusion of phase III (pilot RCT), we will have preliminary effect sizes to inform a future fully powered RCT on changes in (1) knowledge about lung cancer and screening, (2) perceived risk of lung cancer, (3) perceived benefits of lung cancer screening, (4) perceived barriers to lung cancer screening, (5) self-efficacy for lung cancer screening, and (6) perceptions of being adequately prepared to engage in a discussion with their clinician about lung cancer screening.

  • Source: Flickr; Copyright: Simon Fraser University; URL: https://www.flickr.com/photos/sfupamr/8981968330/in/photostream/; License: Creative Commons Attribution (CC-BY).

    Improving Transition to Employment for Youth With Physical Disabilities: Protocol for a Peer Electronic Mentoring Intervention

    Abstract:

    Background: Although youth with disabilities have much to gain from employment readiness programs, they are often excluded from or have limited access to vocational programs. One encouraging approach to address gaps in vocational programming is through peer electronic mentoring (e-mentoring), which may facilitate a smoother transition to adulthood by offering support to enhance coping skills. Despite the increase in online communities, little is known about their impact on vocational mentoring for youth with physical disabilities and their parents. Objective: The aim of this paper is to develop, implement, and assess the feasibility of an online peer mentor employment readiness intervention for youth with physical disabilities and their parents to improve their self-determination, career maturity, and social support compared to controls. Methods: A mixed-methods feasibility randomized controlled trial (RCT) design will be conducted to develop and assess the feasibility, acceptability, and initial efficacy of the “Empowering Youth Towards Employment” intervention. Youth (aged 15 to 25) with physical disabilities and their parents will be randomly assigned to a control or experimental group (4-week, interactive intervention, moderated by peer mentors). Results: Data collection is in progress. Planned analyses include pre-post measures to determine the impact of the intervention on self-determination, career maturity, and social support. A qualitative thematic analysis of the discussion forums will complement the surveys to better understand why certain outcomes may have occurred. Conclusions: Our intervention includes evidence-informed content and was co-created by a multi-disciplinary group of researchers and knowledge users. It has the potential for widespread implications as a cost-effective resource to supplement educational and vocational programming for youth with disabilities. Trial Registration: Clinicaltrials.gov NCT02522507; https://clinicaltrials.gov/ct2/show/NCT02522507 (Archived by WebCite at http://www.webcitation.org/6uD58Pvjc)

  • Source: Flickr; Copyright: Lee Haywood; URL: https://www.flickr.com/photos/leehaywood/5266525534; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).

    Should Medical Assistance in Dying Be Extended to Incompetent Patients With Dementia? Research Protocol of a Survey Among Four Groups of Stakeholders From...

    Abstract:

    Background: Alzheimer’s disease and related disorders affect a growing number of people worldwide. Quality of life is generally good in the early stages of these diseases. However, many individuals fear living through the advanced stages. Such fears are triggering requests for medical assistance in dying (MAiD) by patients with dementia. Legislation was recently passed in Canada and the province of Quebec allowing MAiD at the explicit request of a patient who meets a set of eligibility criteria, including competence. Some commentators have argued that MAiD should be accessible to incompetent patients as well, provided appropriate safeguards are in place. Governments of both Quebec and Canada are currently considering whether MAiD should be accessible through written requests made in advance of loss of capacity. Objective: Aimed at informing the societal debate on this sensitive issue, this study will compare stakeholders’ attitudes towards expanding MAiD to incompetent patients with dementia, the beliefs underlying stakeholders’ attitudes on this issue, and the value they attach to proposed safeguards. This paper describes the study protocol. Methods: Data will be collected via a questionnaire mailed to random samples of community-dwelling seniors, relatives of persons with dementia, physicians, and nurses, all residing in Quebec (targeted sample size of 385 per group). Participants will be recruited through the provincial health insurance database, Alzheimer Societies, and professional associations. Attitudes towards MAiD for incompetent patients with dementia will be elicited through clinical vignettes featuring a patient with Alzheimer’s disease for whom MAiD is considered towards the end of the disease trajectory. Vignettes specify the source of the request (from the patient through an advance request or from the patient’s substitute decision-maker), manifestations of suffering, and how close the patient is to death. Arguments for or against MAiD are used to elicit the beliefs underlying respondents’ attitudes. Results: The survey was launched in September 2016 and is still ongoing. At the time of submission, over 850 respondents have returned the questionnaire, mostly via mail. Conclusions: This study will be the first in Canada to directly compare views on MAiD for incompetent patients with dementia across key stakeholder groups. Our findings will contribute valuable data upon which to base further debate about whether MAiD should be accessible to incompetent patients with dementia, and if so, under what conditions.

  • Source: Pixabay; Copyright: Gerd Altmann; URL: https://pixabay.com/en/school-questions-who-what-how-why-2253459/; License: Public Domain (CC0).

    The Association of Health Literacy and Electronic Health Literacy With Self-Efficacy, Coping, and Caregiving Perceptions Among Carers of People With...

    Abstract:

    Background: In the last decade, electronic health (eHealth) literacy has attracted the attention of the scientific community, as it is associated with the self-management of patients with chronic diseases and the quality and cost of care. It is estimated that 80% of people with chronic diseases are cared for at home by a family member, friend, or relative. Informal carers are susceptible to physical and mental health problems, as well as social and financial hardships. Nevertheless, there seems to be a research gap in terms of carers’ needs, skills, and available resources in the age of new technologies, with the vital role of eHealth literacy of the carers remaining unexplored. Objective: The aim of this study was to investigate the level of eHealth literacy and health literacy of primary and secondary carers of people with dementia, to explore the association between health and eHealth literacy, as well as their association with the caregiving variables: self-efficacy, coping, and caring perceptions. Methods: A sample of 200 primary carers (the carer who supports the people with dementia in everyday living) and 200 secondary carers (family member, friend, or other person in the social network assisting the primary carer in their role) will be recruited from dementia day care centers and Alzheimer’s associations in Greece and Cyprus. The study will be a cross-sectional correlational descriptive study. Tools to be used include the eHealth Literacy Scale adapted for carers to measure eHealth literacy, European Health Literacy Survey Questionnaire 16 (HLS-EU-Q16), Single Item Literacy Screener, Revised Scale for Caregiving Self-Efficacy, Carers of Older People in Europe (COPE) index for caregiving perceptions, and COPE brief to measure selected coping strategies. Descriptive statistics will be reported, and correlations between different variables will be explored with parametric and nonparametric measures. Results: As a preliminary study, the HLS-EU-Q16 has been validated in 107 older people. The internal consistency of the scale as estimated using Cronbach alpha coefficient was .77, somewhat lower than other validation studies. Recruitment of pilot study participants started in May 2017. Conclusions: Carers’ eHealth literacy is a new field. Whereas previous studies have focused on the role and impact of low eHealth literacy and health literacy among older adults, the eHealth literacy of carers, and in fact carers of people with dementia, has not been explored. We hypothesize an association between eHealth literacy and health literacy level with carers’ perceptions about caregiving role, self-efficacy, and coping strategies. A possible moderator in these associations is the secondary carers’ eHealth and health literacy level, which will also be explored. By confirming the above hypotheses, tailored eHealth literacy interventions for carers of people with dementia and their families will be developed as a direct outcome of this research.

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    Open Peer Review Period: Nov 24, 2017 - Dec 8, 2017

    Background: Accurate safety monitoring in HIV vaccine trials is vital to eventual licensure and consequent uptake of products. Current practice is to capture related side effects in a hardcopy tool, r...

    Background: Accurate safety monitoring in HIV vaccine trials is vital to eventual licensure and consequent uptake of products. Current practice is to capture related side effects in a hardcopy tool, reconciled post vaccination, which is time-consuming, laborious and fraught with error. Unstructured Supplementary Service Data (USSD), commonly used to purchase airtime, has been suggested for collection of safety data in vaccine trials. With saturated access to mobile phones in South Africa, this cheap, accessible tool, may improve accuracy and completeness of collected data, and prove feasible and acceptable over the hardcopy tool. Objective: To develop and implement an USSD tool for real time safety data collection, that is feasible and acceptable to participants and staff, allowing for a completeness and accuracy comparison with the hardcopy tool. Methods: This pilot study of Mobile Technology to Assess Reactogenicity (pMOTAR) is being conducted at a single study site in South Africa enrolling participants in a phase 1/2a preventive HIV vaccine trial, as an open-label, randomised controlled trial, to all consenting HVTN 108 participants who continue to receive vaccinations. Participants are randomised 1: 1 to the hardcopy or USSD tool, with data collection targeted to the 3rd and 4th injections in the parent trial. Online feasibility and acceptability surveys will be completed by staff and participants at the post-vaccination visit. Error rates between the hardcopy tool and the USSD print-out and associated documentation will be itemised and compared. We hypothesize that the USSD tool will be shown to be feasible and acceptable to staff and participants and to have superior quality and completion rates to the hardcopy tool. Results: The study has received regulatory approval. The USSD tool has been designed and developed to include all the data fields required for reactogenicity reporting. Online feasibility and accessibility surveys in both languages have been successfully installed on a tablet. The study has been initiated. Conclusions: Several HIV preventive vaccine trials are currently active in Southern Africa, making tools to improve efficiencies and minimise error necessary. Our results will help to determine if the USSD tool can be used in future vaccine studies and eventual roll out.

  • Economic Evaluation Protocol of Thought Spot: A Web- and Mobile-Based Map of Mental Health Resources for Transition-Aged Youth

    Date Submitted: Nov 22, 2017

    Open Peer Review Period: Nov 23, 2017 - Dec 7, 2017

    Background: Youth demonstrate a low propensity to seek help for mental health issues and exhibit low use of health services despite the high prevalence of mental health challenges in this population....

    Background: Youth demonstrate a low propensity to seek help for mental health issues and exhibit low use of health services despite the high prevalence of mental health challenges in this population. Research has found that delivering interventions via the Internet and mobile devices is an effective way to reach youth. Thought Spot, a Web- and mobile-based map, was developed to help students overcome barriers to help-seeking, thereby reducing the economic burden associated with untreated mental health issues. Objective: This paper presents the protocol of an economic evaluation that will be conducted in conjunction with a randomized controlled trial (RCT) to evaluate the effectiveness and cost of Thought Spot compared with usual care in terms of self-efficacy around mental health help-seeking among post-secondary students. The evaluation will focus on the perspective of post-secondary institutions over a 6-month period. Methods: A partially blinded RCT will be conducted to assess the impact of Thought Spot on the self-efficacy of students around mental health help-seeking. Students from three post-secondary institutions in Ontario will be randomly allocated to either the control arm or the intervention arm. Participants in the control arm will receive usual care and those in the intervention arm will receive usual care in addition to access to the Thought Spot platform. The economic evaluation will focus on the perspective of post-secondary institutions or other organizations interested in using Thought Spot. Costs and resources for operating and maintaining the platform will be reported and compared with the costs and resource needs associated with usual care. The primary outcome will be change in help-seeking intentions, which will be measured using the General Help-Seeking Questionnaire. Secondary outcomes will include help-seeking behaviours and help-seeking attitudes, which will be measured using the Actual Help-Seeking Questionnaire and the Attitudes towards Seeking Professional Psychological Help Scale – Short Form. The study will take place over 6 months, and questionnaires will be administered at baseline, 3 months and 6 months. The cost-effectiveness of the intervention will be determined by calculating the incremental cost-effectiveness ratio, which will then be compared with willingness to pay. The findings will form the basis for making recommendations about the future use of Thought Spot. Results: The first phase of the project was completed in September 2017 and informed the redevelopment of the new version of Thought Spot, which was completed in December 2017. The RCT is scheduled to begin in early 2018 and will run for 6 months, after which the economic evaluation will be completed. Conclusions: We expect to demonstrate that Thought Spot is a cost-effective way to improve help-seeking intentions and encourage help-seeking behaviour among transition-aged youth. The findings of this study will help to inform post-secondary institutions when they are allocating resources for mental health initiatives.

  • CANreduce 2.0 – the effects of social presence on adherence-focused guidance in problematic cannabis users: study protocol for a three-arm randomized controlled trial

    Date Submitted: Nov 23, 2017

    Open Peer Review Period: Nov 23, 2017 - Dec 1, 2017

    Background: In European countries, including Switzerland, cannabis is the most commonly used illicit drug. Offering a web-based self-help tool could potentially reach users who otherwise would not see...

    Background: In European countries, including Switzerland, cannabis is the most commonly used illicit drug. Offering a web-based self-help tool could potentially reach users who otherwise would not seek traditional help. However, such web-based self-help tools often suffer from low adherence. Objective: Through adherence-focused guidance enhancements, we aim to increase adherence in cannabis users entering a web-based self-help tool to reduce their cannabis use and, in this way, augment its effectiveness. Methods: This paper presents the protocol for a three-arm randomized controlled trial (RCT) to compare the effectiveness of (1) an adherence-focused, guidance-enhanced web-based self-help intervention, (2) an adherence-focused, unenhanced web-based self-help intervention, and (3) treatment as usual at reducing cannabis use in problematic users. The two active interventions, each spanning six weeks, consist of modules designed to reduce cannabis use and attenuate common mental disorder (CMD) symptoms, including depression, anxiety and stress-related disorder symptoms, based on the approaches of motivational interviewing and cognitive behavioural therapy. Data will be collected at baseline, 6 weeks and 3 months after baseline. The primary outcome measurement will be the number of days per week of cannabis use. Secondary outcomes will include the quantity of cannabis used in standardized cannabis joints, the severity of cannabis dependence, changes in CMD symptoms, and adherence to the program. Data analysis will follow the intention-to-treat principle and employ (generalised) linear mixed models. Results: Results will provide detailed insight if and how effectiveness of a web-based self-help intervention aiming to reduce cannabis use in frequent cannabis users can be improved by theory-driven adherence-focused guidance-enhancement. Conclusions: - Clinical Trial: Trial registration number ISRCTN11086185

  • Validation of a Machine Learning Algorithm to Predict 30-Day Readmissions in Patients with Heart Failure: Protocol for a Prospective Cohort Study

    Date Submitted: Nov 20, 2017

    Open Peer Review Period: Nov 20, 2017 - Dec 4, 2017

    Background: Big data solutions, particularly machine learning predictive algorithms, have demonstrated the ability to unlock value from data in real-time in many settings outside of healthcare. Rapid...

    Background: Big data solutions, particularly machine learning predictive algorithms, have demonstrated the ability to unlock value from data in real-time in many settings outside of healthcare. Rapid growth in electronic medical record adoption, and the shift from a volume-based to a value-based reimbursement structure in the United States healthcare system has spurred investments into machine learning solutions. Machine learning methods can be used to build flexible, customized and automated predictive models to optimize resource allocation and improve the efficiency and quality of healthcare. However, these models are prone to the problems of overfitting, confounding and decay in predictive performance over time. It is therefore necessary to evaluate machine-learning based predictive models in an independent dataset before they can be adopted in clinical practice. In this paper, we describe the protocol for an independent, prospective validation of a machine-learning based model trained to predict the risk of 30-day readmission in patients with heart failure. Objective: To prospectively validate a machine learning-based predictive model for inpatient admissions in heart failure patients by comparing its predictions of risk for 30-day readmissions against outcomes observed prospectively in an independent patient cohort. Methods: All adult patients with heart failure who are discharged alive from an inpatient admission will be prospectively monitored for 30-day readmissions through reports generated by the electronic medical record system. Of these, patients who were part of the training dataset will be excluded to avoid information leakage to the algorithm. An expected sample size of 1228 index admissions will be required to observe a minimum of 100 30-day readmission events. De-identified structured and unstructured data will be fed to the algorithm and its prediction recorded. Overall model performance will be assessed using the concordance statistic. Multiple discrimination thresholds for screening high risk patients will also be evaluated based on sensitivity, specificity, predictive values and estimated cost savings to our healthcare system. Results: Results are expected by mid-2018. Conclusions: To our knowledge, this is one of the first studies to prospectively evaluate a predictive machine learning algorithm in a real-world setting. Findings from this study will help to measure the robustness of predictions made by machine learning algorithms, and to set a realistic benchmark for expectations of gains that can be made through its application to healthcare.

  • Effectiveness of a blended and integrated mental health and physical therapy intervention program (PARASOL) for patients with moderate medically unexplained physical symptoms to prevent chronicity: study protocol of a cluster randomized clinical trial

    Date Submitted: Nov 17, 2017

    Open Peer Review Period: Nov 20, 2017 - Dec 4, 2017

    Background: Medically unexplained physical symptoms (MUPS) are an important health problem in primary care, with a spectrum from mild to chronic. The burden of chronic MUPS is substantial for patients...

    Background: Medically unexplained physical symptoms (MUPS) are an important health problem in primary care, with a spectrum from mild to chronic. The burden of chronic MUPS is substantial for patients, health care professionals and society. Therefore, early identification of patients with moderate MUPS is needed, enabling prevention of chronicity. We developed the PRESUME screenings method using data from the electronic medical record of the general practitioner and demonstrated its prognostic accuracy to identify patients with moderate MUPS. In the next step we developed a proactive blended and integrated mental health and physical therapy intervention program (PARASOL), to reduce complaints of moderate MUPS, stimulate self-management and prevent chronicity. Objective: The primary objective of this study is to investigate the effectiveness of the blended PARASOL intervention on the impact of symptoms and quality of life in patients with moderate MUPS compared with usual care. Methods: This paper presents the study protocol of a multicenter cluster randomized clinical trial. Adult patients with moderate MUPS will be identified in electronic medical record data using the PRESUME screening and proactively recruited for participation in the study. Cluster randomization will be performed at the level of the participating health care centers. In total 248 patients with moderate MUPS (per arm 124 patients) are needed. The PARASOL intervention is a 12-week blended primary care program consisting of four face to face consultations with the mental health nurse and five physical therapy sessions, supplemented with a web-based program. The web-based program contains of (1) information modules and video’s on self-management and educative themes, (2) video’s and instructions on prescribed home exercises and (3) assignments to gradually increasing physical activity program. The program is directed at patients’ perception of symptoms, and modifiable prognostic risk factors for chronicity using therapeutic neuroscience education and encouraging self-management as well as an active lifestyle using a cognitive behavioural approach and graded activity. Primary outcomes are impact of symptoms and quality of life. Secondary outcomes are severity of (psychosocial) symptoms, general health, physical behaviour, illness perceptions, self-efficacy and cost-effectiveness. All measurements will be performed at baseline, three and twelve months after baseline. Retrospective cost questionnaires will also be sent at six and nine months after baseline, used for the cost-effectiveness analysis. Results: The inclusion of patients started in March 2017. Follow-up assessments will last until March 2019. Conclusions: This study is the first randomized clinical trial in the (cost-)effectiveness of a proactive, blended and integrated mental health and physical therapy care program for patients with moderate MUPS. The findings will help to improve the treatment for patients with moderate MUPS and prevent chronicity. Clinical Trial: NTR: 6755 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6755

  • Oncosurgical management of liver limited stage four colorectal cancer – preliminary data and a trial protocol

    Date Submitted: Nov 19, 2017

    Open Peer Review Period: Nov 19, 2017 - Dec 3, 2017

    Colorectal cancer is the fourth commonest cancer and second commonest cause of cancer related death in the UK. Almost 15% of patients have metastases on presentation. An increasing number of surgical...

    Colorectal cancer is the fourth commonest cancer and second commonest cause of cancer related death in the UK. Almost 15% of patients have metastases on presentation. An increasing number of surgical strategies and better neoadjuvant treatment are bringing more patients to resection of liver metastases with prolonged survival in a select group of patients who present with synchronous disease.It is clear that the optimal strategy for the management of these patients remains unclear, and there is certainly a complete absence of Level 1 evidence in the literature. We have undertaken some preliminary work and begun the process of designing a randomized controlled trial, and present a draft trial protocol here. We do not believe however that the trial we have designed will answer the most significant clinical questions, nor that it is feasible to be delivered within the United Kingdom’s National Health Service at this current time.

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