JMIR Research Protocols

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

Design and implementation of a ‘community fit’ CBPR programme for family health, happiness and harmony

Background: As a principal factor in maintaining positive family functioning and well-being, family communication time is decreasing in modern societies such as Hong Kong, where long working hours and indulgent use of information technology are typical. Objective: To promote family health, happiness and harmony (3Hs). Methods: This paper describes an innovative study (‘Happy Family Kitchen’) under the project- “FAMILY: A Jockey Club Initiative for a Harmonious Society” with a combination of the community-based participatory research (CBPR) approach, principles of positive psychology traditional Chinese concepts of cooking and dining as a means to connect family members so as to promote family health, happiness and harmony (3Hs). Results: In-depth collaboration was developed between an academic institution and a large non-governmental community organisation with an umbrella of 400 social service agencies. Both parties were deeply involved together in project design, implementation and evaluation of 24 community-based interventions. This was the first CBPR study on Chinese, and the results should be useful in informing collaborative intervention programmes engaging public health researchers and community social service providers, major stakeholders and community participants in the promotion of family well-being. Conclusions: The study has generated an effective practice model for the improvement of family communication and well-being. Some challenges concerned with project implementation and research rigour need to specify.

2015-02-19

We are pleased to announce our forthcoming new journals, all of which have currently no submission or publication fees, and all of which focus on emerging technologies and patient-centered innovations in specific areas, going beyond Internet/webbased interventions: * JMIR Cancer (http://cancer.jmir.org) * JMIR Medical Education (http://mededu.jmir.org) * JMIR Public Health and Surveillance (http://publichealth.jmir.org) We welcome submissions for the inaugural issues of these journals. The following journals have already published articles and are still free of charge to publish in (no submission or publication fees): * JMIR Human Factors (http://humanfactors.jmir.org) * JMIR Rehabilitation and Assistive Technologies (http://rehab.jmir.org) * JMIR Mental Health (http://mental.jmir.org) To submit to these journals, simply append /author to the URLs above (e.g. http://cancer.jmir.org/author), or submit to the main JMIR journal and use the dropdown-box in step 1 to change the journal name. All journals offer careful copyediting and typesetting of manuscripts, and submission to PubMed and PubMed Central (being new journals it may however take a few month until they appear in PubMed). We are also happy to announce that JMIR Medical Informatics and JMIR Serious Games are now indexed in PubMed.

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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: 4.7)
  • JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions
  • JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central
  • Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort 
  • JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal
  • JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols
  • JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced
  • JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods
  • Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine
  • Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others)
 
 

Recent Articles:

  • Gold Apollo Pager (Image Source: http://en.wikipedia.org/wiki/Pager#mediaviewer/File:Np88_support.jpg, CC BY-SA 3.0, Uploaded by Liangent).

    Optimizing Inter-Professional Communications in Surgery: Protocol for a Mixed-Methods Exploratory Study

    Abstract:

    Background: Effective nurse-physician communication is critical to delivering high quality patient care. Interprofessional communication between surgical nurses and surgeons, often through the use of pagers, is currently characterized by information gaps and interprofessional tensions, both sources of workflow interruption, potential medical error, impaired educational experience, and job satisfaction. Objective: This study aims to define current patterns of, and understand enablers and barriers to interprofessional communication in general surgery, in order to optimize the use of communication technologies, teamwork, provider satisfaction, and quality and safety of patient care. Methods: We will use a mixed-methods multiphasic approach. In phase 1, a quantitative and content analysis of alpha-numeric pages (ANP) received by general surgery residents will be conducted to develop a paging taxonomy. Frequency, timing (on-call vs regular duty hours), and interval between pages will be described using a 4-week sample of pages. Results will be compared between pages sent to junior and senior residents. Finally, using an inductive analysis, two independent assessors will classify ANP thematically. In Phase 2, a qualitative constructivist approach will explore stakeholders’ experiences with interprofessional communication, including paging, through interviews and shadowing of 40 residents and 40 nurses at two institutions. Finally, a survey will be developed, tested, and administered to all general surgery nurses and residents at the same two institutions, to evaluate their attitudes about the effectiveness and quality of interprofessional communication, and assess their satisfaction. Results: Describing the profile of current pages is the first step towards identifying areas and root causes of IPC inefficiency. This study will identify key contextual barriers to surgical nurse-house staff communication, and existing interprofessional knowledge and practice gaps. Conclusions: Our findings will inform the design of a guideline and tailored intervention to improve IPC in order to ensure high quality patient care, optimal educational experience, and provider satisfaction.

  • Origin – Author Creation: Margeaux Chavez, License/Attribution Information – N/A.

    A Participatory Approach to Designing and Enhancing Integrated Health Information Technology Systems for Veterans: Protocol

    Abstract:

    Background: The Department of Veterans Affairs (VA) has developed health information technologies (HIT) and resources to improve veteran access to health care programs and services, and to support a patient-centered approach to health care delivery. To improve VA HIT access and meaningful use by veterans, it is necessary to understand their preferences for interacting with various HIT resources to accomplish health management related tasks and to exchange information. Objective: The objective of this paper was to describe a novel protocol for: (1) developing a HIT Digital Health Matrix Model; (2) conducting an Analytic Hierarchy Process called pairwise comparison to understand how and why veterans want to use electronic health resources to complete tasks related to health management; and (3) developing visual modeling simulations that depict veterans’ preferences for using VA HIT to manage their health conditions and exchange health information. Methods: The study uses participatory research methods to understand how veterans prefer to use VA HIT to accomplish health management tasks within a given context, and how they would like to interact with HIT interfaces (eg, look, feel, and function) in the future. This study includes two rounds of veteran focus groups with self-administered surveys and visual modeling simulation techniques. This study will also convene an expert panel to assist in the development of a VA HIT Digital Health Matrix Model, so that both expert panel members and veteran participants can complete an Analytic Hierarchy Process, pairwise comparisons to evaluate and rank the applicability of electronic health resources for a series of health management tasks. Results: This protocol describes the iterative, participatory, and patient-centered process for: (1) developing a VA HIT Digital Health Matrix Model that outlines current VA patient-facing platforms available to veterans, describing their features and relevant contexts for use; and (2) developing visual model simulations based on direct veteran feedback that depict patient preferences for enhancing the synchronization, integration, and standardization of VA patient-facing platforms. Focus group topics include current uses, preferences, facilitators, and barriers to using electronic health resources; recommendations for synchronizing, integrating, and standardizing VA HIT; and preferences on data sharing and delegation within the VA system. Conclusions: This work highlights the practical, technological, and personal factors that facilitate and inhibit use of current VA HIT, and informs an integrated system redesign. The Digital Health Matrix Model and visual modeling simulations use knowledge of veteran preferences and experiences to directly inform enhancements to VA HIT and provide a more holistic and integrated user experience. These efforts are designed to support the adoption and sustained use of VA HIT to support patient self-management and clinical care coordination in ways that are directly aligned with veteran preferences.

  • Screenshot of a video from the study with full participant consent.

    Competency-Based Assessment for Clinical Supervisors: Design-Based Research on a Web-Delivered Program

    Abstract:

    Background: Clinicians need to be supported by universities to use credible and defensible assessment practices during student placements. Web-based delivery of clinical education in student assessment offers professional development regardless of the geographical location of placement sites. Objective: This paper explores the potential for a video-based constructivist Web-based program to support site supervisors in their assessments of student dietitians during clinical placements. Methods: This project was undertaken as design-based research in two stages. Stage 1 describes the research consultation, development of the prototype, and formative feedback. In Stage 2, the program was pilot-tested and evaluated by a purposeful sample of nine clinical supervisors. Data generated as a result of user participation during the pilot test is reported. Users’ experiences with the program were also explored via interviews (six in a focus group and three individually). The interviews were transcribed verbatim and thematic analysis conducted from a pedagogical perspective using van Manen’s highlighting approach. Results: This research succeeded in developing a Web-based program, “Feed our Future”, that increased supervisors’ confidence with their competency-based assessments of students on clinical placements. Three pedagogical themes emerged: constructivist design supports transformative Web-based learning; videos make abstract concepts tangible; and accessibility, usability, and pedagogy are interdependent. Conclusions: Web-based programs, such as Feed our Future, offer a viable means for universities to support clinical supervisors in their assessment practices during clinical placements. A design-based research approach offers a practical process for such Web-based tool development, highlighting pedagogical barriers for planning purposes.

  • (cc) Baron et al. CC-BY-SA-2.0, please cite as (http://www.researchprotocols.org/article/viewFile/4035/1/53920).

    A Mobile Telehealth Intervention for Adults With Insulin-Requiring Diabetes: Early Results of a Mixed-Methods Randomized Controlled Trial

    Abstract:

    Background: The role of technology in health care delivery has grown rapidly in the last decade. The potential of mobile telehealth (MTH) to support patient self-management is a key area of research. Providing patients with technological tools that allow for the recording and transmission of health parameters to health care professionals (HCPs) may promote behavior changes that result in improved health outcomes. Although for some conditions the evidence of the effectiveness of MTH is clear, to date the findings on the effects of MTH on diabetes management remain inconsistent. Objective: This study aims to evaluate an MTH intervention among insulin-requiring adults with diabetes to establish whether supplementing standard care with MTH results in improved health outcomes—glycated hemoglobin (HbA1c), blood pressure (BP), health-related quality of life (HRQoL), diabetes self-management behaviors, diabetes health care utilization, and diabetes self-efficacy and illness beliefs. An additional objective was to explore the acceptability of MTH and patients’ perceptions of, and experience, using it. Methods: A mixed-method design consisting of a 9-month, two-arm, parallel randomized controlled trial (RCT) was used in combination with exit qualitative interviews. Quantitative data was collected at baseline, 3 months, and 9 months. Additional intervention fidelity data, such as participants’ MTH transmissions and contacts with the MTH nurse during the study, were also recorded. Results: Data collection for both the quantitative and qualitative components of this study has ended and data analysis is ongoing. A total of 86 participants were enrolled into the study. Out of 86 participants, 45 (52%) were randomized to the intervention group and 36 (42%) to the control group. Preliminary data on MTH training sessions and MTH usage by intervention participants are presented in this paper. We expect to publish complete study results in 2015. Conclusions: The range of data collected in this study will allow for a comprehensive evaluation of processes and outcomes. The early results presented suggest that MTH usage decreases over time and that MTH participants would benefit from attending more than one training session. Trial Registration: ClinicalTrials.gov NCT00922376; http://clinicaltrials.gov/ct2/show/NCT00922376 (Archived by WebCite at http://www.webcitation.org/6Vu4nhLI6).

  • This image was purchased from ThinkStock.

    The Effect of Online Chronic Disease Personas on Activation: Within-Subjects and Between-Groups Analyses

    Abstract:

    Background: Although self-management of chronic disease is important, engaging patients and increasing activation for self-care using online tools has proven difficult. Designing more tailored interventions through the application of condition-specific personas may be a way to increase engagement and patient activation. Personas are developed from extensive interviews with patients about their shared values and assumptions about their health. The resulting personas tailor the knowledge and skills necessary for self-care and guide selection of the self-management tools for a particular audience. Objective: Pre-post changes in self-reported levels of activation for self-management were analyzed for 11 chronic health personas developed for 4 prevalent chronic diseases. Methods: Personas were created from 20 to 25 hour-long nondirected interviews with consumers with a common, chronic disease (eg, diabetes). The interviews were transcribed and coded for behaviors, feelings, and beliefs using the principles of grounded theory. A second group of 398 adults with self-reported chronic disease were recruited for online testing of the personas and their impact on activation. The activation variables, based on an integrated theory of health behavior, were knowledge of a given health issue, perceived self-management skills, confidence in improving health, and intention to take action in managing health. Pre-post changes in activation were analyzed with a mixed design with 1 within-subjects factor (pre-post) and 1 between-group factor (persona) using a general linear model with repeated measures. Results: Sixteen pre-post changes for 4 measures of activation were analyzed. All but 2 of the within-subjects effects were statistically significant and all changes were in the direction of increased activation scores at posttest. Five significant differences between personas were observed, showing which personas performed better. Of low activation participants, 50% or more shifted to high activation across the 4 measures with minimal changes (≤5%) in the reverse direction. Conclusions: The majority of participants using a persona-tailored learning path reported high levels of satisfaction with their online user experience and increased levels of activation about their own health. In the body of work on patient activation, the current study adds to understanding of both short-term impact and the content of a brief, online intervention for engagement of specific groups in self-management.

  • Cartoon showing multiple stakeholders using and contributing to a wiki (cartoon drawn by Yves Lessard).

    Implementation and Evaluation of a Wiki Involving Multiple Stakeholders Including Patients in the Promotion of Best Practices in Trauma Care: The WikiTrauma...

    Abstract:

    Background: Trauma is the most common cause of mortality among people between the ages of 1 and 45 years, costing Canadians 19.8 billion dollars a year (2004 data), yet half of all patients with major traumatic injuries do not receive evidence-based care, and significant regional variation in the quality of care across Canada exists. Accordingly, our goal is to lead a research project in which stakeholders themselves will adapt evidence-based trauma care knowledge tools to their own varied institutional contexts and cultures. We will do this by developing and assessing the combined impact of WikiTrauma, a free collaborative database of clinical decision support tools, and Wiki101, a training course teaching participants how to use WikiTrauma. WikiTrauma has the potential to ensure that all stakeholders (eg, patients, clinicians, and decision makers) can all contribute to, and benefit from, evidence-based clinical knowledge about trauma care that is tailored to their own needs and clinical setting. Objective: Our main objective will be to study the combined effect of WikiTrauma and Wiki101 on the quality of care in four trauma centers in Quebec. Methods: First, we will pilot-test the wiki with potential users to create a version ready to test in practice. A rapid, iterative prototyping process with 15 health professionals from nonparticipating centers will allow us to identify and resolve usability issues prior to finalizing the definitive version for the interrupted time series. Second, we will conduct an interrupted time series to measure the impact of our combined intervention on the quality of care in four trauma centers that will be selected—one level I, one level II, and two level III centers. Participants will be health care professionals working in the selected trauma centers. Also, five patient representatives will be recruited to participate in the creation of knowledge tools destined for their use (eg, handouts). All participants will be invited to complete the Wiki101 training and then use, and contribute to, WikiTrauma for 12 months. The primary outcome will be the change over time of a validated, composite, performance indicator score based on 15 process performance indicators found in the Quebec Trauma Registry. Results: This project was funded in November 2014 by the Canadian Medical Protective Association. We expect to start this trial in early 2015 and preliminary results should be available in June 2016. Two trauma centers have already agreed to participate and two more will be recruited in the next months. Conclusions: We expect that this study will add important and unique evidence about the effectiveness, safety, and cost savings of using collaborative platforms to adapt knowledge implementation tools across jurisdictions.

  • Short Inflammatory Bowel Disease Questionnaire.

    Impact of the Mobile HealthPROMISE Platform on the Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease: Study Protocol of a...

    Abstract:

    Background: Inflammatory bowel disease (IBD) is a chronic condition of the bowel that affects over 1 million people in the United States. The recurring nature of disease makes IBD patients ideal candidates for patient-engaged care that is centered on enhanced self-management and improved doctor-patient communication. In IBD, optimal approaches to management vary for patients with different phenotypes and extent of disease and past surgical history. Hence, a single quality metric cannot define a heterogeneous disease such as IBD, unlike hypertension and diabetes. A more comprehensive assessment may be provided by complementing traditional quality metrics with measures of the patient’s quality of life (QOL) through an application like HealthPROMISE. Objective: The objective of this pragmatic randomized controlled trial is to determine the impact of the HealthPROMISE app in improving outcomes (quality of care [QOC], QOL, patient adherence, disease control, and resource utilization) as compared to a patient education app. Our hypothesis is that a patient-centric self-monitoring and collaborative decision support platform will lead to sustainable improvement in overall QOL for IBD patients. Methods: Participants will be recruited during face-to-face visits and randomized to either an interventional (ie, HealthPROMISE) or control (ie, education app). Patients in the HealthPROMISE arm will be able to update their information and receive disease summary, quality metrics, and a graph showing the trend of QOL (SIBDQ) scores and resource utilization over time. Providers will use the data for collaborative decision making and quality improvement interventions at the point of care. Patients in the control arm will enter data at baseline, during office visits, and at the end of the study but will not receive any decision support (trend of QOL, alert, or dashboard views). Results: Enrollment in the trial will be starting in first quarter of 2015. It is intended that up to 300 patients with IBD will be recruited into the study (with 1:1 allocation ratio). The primary endpoint is number of quality indicators met in HealthPROMISE versus control arm. Secondary endpoints include decrease in number of emergency visits due to IBD, decrease in number of hospitalization due to IBD, change in generic QOL score from baseline, proportion of patients in each group who meet all eligible outpatient quality metrics, and proportion of patients in disease control in each group. In addition, we plan to conduct protocol analysis of intervention patients with adequate HealthPROMISE utilization (more than 6 log-ins with data entry from week 0 through week 52) achieving above mentioned primary and secondary endpoints. Conclusions: HealthPROMISE is a unique cloud-based patient-reported outcome (PRO) and decision support tool that empowers both patients and providers. Patients track their QOL and symptoms, and providers can use the visual data in real time (integrated with electronic health records [EHRs]) to provide better care to their entire patient population. Using pragmatic trial design, we hope to show that IBD patients who participate in their own care and share in decision making have appreciably improved outcomes when compared to patients who do not. Trial Registration: ClinicalTrials.gov NCT02322307; https://clinicaltrials.gov/ct2/show/NCT02322307 (Archived by WebCite at http://www.webcitation.org/6W8PoYThr).

  • Diabète en Forme.

    Development of a Fully Automated, Web-Based, Tailored Intervention Promoting Regular Physical Activity Among Insufficiently Active Adults With Type 2...

    Abstract:

    Background: Type 2 diabetes is a major challenge for Canadian public health authorities, and regular physical activity is a key factor in the management of this disease. Given that fewer than half of people with type 2 diabetes in Canada are sufficiently active to meet the recommendations, effective programs targeting the adoption of regular physical activity (PA) are in demand for this population. Many researchers argue that Web-based, tailored interventions targeting PA are a promising and effective avenue for sedentary populations like Canadians with type 2 diabetes, but few have described the detailed development of this kind of intervention. Objective: This paper aims to describe the systematic development of the Web-based, tailored intervention, Diabète en Forme, promoting regular aerobic PA among adult Canadian francophones with type 2 diabetes. This paper can be used as a reference for health professionals interested in developing similar interventions. We also explored the integration of theoretical components derived from the I-Change Model, Self-Determination Theory, and Motivational Interviewing, which is a potential path for enhancing the effectiveness of tailored interventions on PA adoption and maintenance. Methods: The intervention development was based on the program-planning model for tailored interventions of Kreuter et al. An additional step was added to the model to evaluate the intervention’s usability prior to the implementation phase. An 8-week intervention was developed. The key components of the intervention include a self-monitoring tool for PA behavior, a weekly action planning tool, and eight tailored motivational sessions based on attitude, self-efficacy, intention, type of motivation, PA behavior, and other constructs and techniques. Usability evaluation, a step added to the program-planning model, helped to make several improvements to the intervention prior to the implementation phase. Results: The intervention development cost was about CDN $59,700 and took approximately 54 full-time weeks. The intervention officially started on September 29, 2014. Out of 2300 potential participants targeted for the tailored intervention, approximately 530 people visited the website, 170 people completed the registration process, and 83 corresponded to the selection criteria and were enrolled in the intervention. Conclusions: Usability evaluation is an essential step in the development of a Web-based tailored intervention in order to make pre-implementation improvements. The effectiveness and relevance of the theoretical framework used for the intervention will be analyzed following the process and impact evaluation. Implications for future research are discussed.

  • This is a royalty free image by Sura Nualpradid (http://www.freedigitalphotos.net/images/patient-in-hospital-photo-p228320).

    Secondary Care Clinic for Chronic Disease: Protocol

    Abstract:

    Background: The complexity of chronic disease management activities and the associated financial burden have prompted the development of organizational models, based on the integration of care and services, which rely on primary care services. However, since the institutions providing these services are continually undergoing reorganization, the Centre hospitalier affilié universitaire de Québec wanted to innovate by adapting the Chronic Care Model to create a clinic for the integrated follow-up of chronic disease that relies on hospital-based specialty care. Objective: The aim of the study is to follow the project in order to contribute to knowledge about the way in which professional and management practices are organized to ensure better care coordination and the successful integration of the various follow-ups implemented. Methods: The research strategy adopted is based on the longitudinal comparative case study with embedded units of analysis. The case study uses a mixed research method. Results: We are currently in the analysis phase of the project. The results will be available in 2015. Conclusions: The project’s originality lies in its consideration of the macro, meso, and micro contexts structuring the creation of the clinic in order to ensure the integration process is successful and to allow a theoretical generalization of the reorganization of practices to be developed.

  • Screenshot from video on hypothetical student completing MCQ-10D.

    Bringing Feedback in From the Outback via a Generic and Preference-Sensitive Instrument for Course Quality Assessment

    Abstract:

    Background: Much effort and many resources have been put into developing ways of eliciting valid and informative student feedback on courses in medical, nursing, and other health professional schools. Whatever their motivation, items, and setting, the response rates have usually been disappointingly low, and there seems to be an acceptance that the results are potentially biased. Objective: The objective of the study was to look at an innovative approach to course assessment by students in the health professions. This approach was designed to make it an integral part of their educational experience, rather than a marginal, terminal, and optional add-on as “feedback”. It becomes a weighted, but ungraded, part of the course assignment requirements. Methods: A ten-item, two-part Internet instrument, MyCourseQuality (MCQ-10D), was developed following a purposive review of previous instruments. Shorthand labels for the criteria are: Content, Organization, Perspective, Presentations, Materials, Relevance, Workload, Support, Interactivity, and Assessment. The assessment is unique in being dually personalized. In part 1, at the beginning of the course, the student enters their importance weights for the ten criteria. In part 2, at its completion, they rate the course on the same criteria. Their ratings and weightings are combined in a simple expected-value calculation to produce their dually personalized and decomposable MCQ score. Satisfactory (technical) completion of both parts contributes 10% of the marks available in the course. Providers are required to make the relevant characteristics of the course fully transparent at enrollment, and the course is to be rated as offered. A separate item appended to the survey allows students to suggest changes to what is offered. Students also complete (anonymously) the standard feedback form in the setting concerned. Results: Piloting in a medical school and health professional school will establish the organizational feasibility and acceptability of the approach (a version of which has been employed in one medical school previously), as well as its impact on provider behavior and intentions, and on student engagement and responsiveness. The priorities for future improvements in terms of the specified criteria are identified at both individual and group level. The group results from MCQ will be compared with those from the standard feedback questionnaire, which will also be completed anonymously by the same students (or some percentage of them). Conclusions: We present a protocol for the piloting of a student-centered, dually personalized course quality instrument that forms part of the assignment requirements and is therefore an integral part of the course. If, and how, such an essentially formative Student-Reported Outcome or Experience Measure can be used summatively, at unit or program level, remains to be determined, and is not our concern here.

  • Demonstration of brainstem audiometry measurement equipment (first author pictured).

    Auditory Brainstem Response as a Diagnostic Tool for Patients Suffering From Schizophrenia, Attention Deficit Hyperactivity Disorder, and Bipolar Disorder:...

    Abstract:

    Background: Psychiatric disorders, such as schizophrenia, attention deficit hyperactivity disorder (ADHD), and bipolar disorder, may sometimes be difficult to diagnose. There is a great need for a valid and reliable diagnostic tool to aid clinicians in arriving at the diagnoses in a timely and accurate manner. Prior studies have suggested that patients suffering from schizophrenia and ADHD may process certain sound stimuli in the brainstem in an unusual manner. When these patient groups have been examined with the electrophysiological method of brainstem audiometry, some studies have found illness-specific aberrations. Such aberrations may also exist for patients suffering from bipolar disorder. Objective: In this study, we will examine whether the method of brainstem audiometry can be used as a diagnostic tool for patients suffering from schizophrenia, ADHD, and bipolar disorder. Methods: The method includes three steps: (1) auditory stimulation with specific sound stimuli, (2) simultaneous measurement of brainstem activity, and (3) automated interpretation of the resulting brain stem audiograms with data-based signal analysis. We will compare three groups of 12 individuals with confirmed diagnoses of schizophrenia, ADHD, or bipolar disorder with 12 healthy subjects under blinded conditions for a total of 48 participants. The extent to which the method can be used to reach the correct diagnosis will be investigated. Results: The project is now in a recruiting phase. When all patients and controls have been recruited and the measurements have been performed, the data will be analyzed according to a previously arranged algorithm. We expect the recruiting phase and measurements to be completed in early 2015, the analyses to be performed in mid-2015, and the results of the study to be published in early 2016. Conclusions: If the results support previous findings, this will lend strength to the idea that brainstem audiometry can offer objective diagnostic support for patients suffering from schizophrenia, ADHD, and bipolar disorder. A positive result from the study could imply that brainstem audiometry could become an important supportive tool for clinicians in their efforts to diagnose patients with these disorders in a timely and accurate manner. Trial Registration: ClinicalTrials.gov NCT01629355; https://clinicaltrials.gov/ct2/show/NCT01629355 (Archived by WebCite at http://www.webcitation.org/6VBfTwx5H).

  • (cc) by Revenäs et al. CC-BY-SA-2.0, please cite as http://www.researchprotocols.org/article/viewFile/3795/1/53171.

    Development of a Web-Based and Mobile App to Support Physical Activity in Individuals With Rheumatoid Arthritis: Results From the Second Step of a Co-Design...

    Abstract:

    Background: Long-term adherence to physical activity recommendations remains challenging for most individuals with rheumatoid arthritis (RA) despite evidence for its health benefits. Objective: The aim of this study was to provide basic data on system requirement specifications for a Web-based and mobile app to self-manage physical activity. More specifically, we explored the target user group, features of the future app, and correlations between the system requirements and the established behavior change techniques (BCTs). Methods: We used a participatory action research design. Qualitative data were collected using multiple methods in four workshops. Participants were 5 individuals with RA, a clinical physiotherapist, an officer from the Swedish Rheumatism Association, a Web designer, and 2 physiotherapy researchers. A taxonomy was used to determine the degree of correlation between the system requirements and established BCTs. Results: Participants agreed that the future Web-based and mobile app should be based on two major components important for maintaining physical activity: (1) a calendar feature for goal setting, planning, and recording of physical activity performance and progress, and (2) a small community feature for positive feedback and support from peers. All system requirements correlated with established BCTs, which were coded as 24 different BCTs. Conclusions: To our knowledge, this study is the first to involve individuals with RA as co-designers, in collaboration with clinicians, researchers, and Web designers, to produce basic data to generate system requirement specifications for an eHealth service. The system requirements correlated to the BCTs, making specifications of content and future evaluation of effectiveness possible.

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  • Design and implementation of a ‘community fit’ CBPR programme for family health, happiness and harmony

    Date Submitted: Feb 26, 2015

    Open Peer Review Period: Feb 26, 2015 - Mar 12, 2015

    Background: As a principal factor in maintaining positive family functioning and well-being, family communication time is decreasing in modern societies such as Hong Kong, where long working hours and...

    Background: As a principal factor in maintaining positive family functioning and well-being, family communication time is decreasing in modern societies such as Hong Kong, where long working hours and indulgent use of information technology are typical. Objective: To promote family health, happiness and harmony (3Hs). Methods: This paper describes an innovative study (‘Happy Family Kitchen’) under the project- “FAMILY: A Jockey Club Initiative for a Harmonious Society” with a combination of the community-based participatory research (CBPR) approach, principles of positive psychology traditional Chinese concepts of cooking and dining as a means to connect family members so as to promote family health, happiness and harmony (3Hs). Results: In-depth collaboration was developed between an academic institution and a large non-governmental community organisation with an umbrella of 400 social service agencies. Both parties were deeply involved together in project design, implementation and evaluation of 24 community-based interventions. This was the first CBPR study on Chinese, and the results should be useful in informing collaborative intervention programmes engaging public health researchers and community social service providers, major stakeholders and community participants in the promotion of family well-being. Conclusions: The study has generated an effective practice model for the improvement of family communication and well-being. Some challenges concerned with project implementation and research rigour need to specify.

  • Rural versus urban health service utilisation and outcomes for renal patients in New South Wales: methods of a data linkage study.

    Date Submitted: Feb 25, 2015

    Open Peer Review Period: Feb 26, 2015 - Mar 12, 2015

    BACKGROUND Kidney disease is a significant burden on health systems globally, with the rising prevalence of End Stage Kidney Disease in Australia mirrored in many other countries. Approximately 25%...

    BACKGROUND Kidney disease is a significant burden on health systems globally, with the rising prevalence of End Stage Kidney Disease in Australia mirrored in many other countries. Approximately 25% of the Australian population lives in regional and rural areas and accessing complex tertiary services is challenging. We aim to compare the burden and outcomes of chronic kidney disease and end stage kidney disease in rural and urban regions of New South Wales (Australia’s most populous state) using linked health data. METHODS This is a retrospective cohort study and we have defined two cohorts: one with end stage kidney disease and one with chronic kidney disease. The end stage kidney disease cohort was defined using the Australia and New Zealand Dialysis and Transplant Registry, identifying all patients living in NSW receiving renal replacement therapy at any time between 01/07/2000 and 31/07/2010. The chronic kidney disease cohort used the NSW Admitted Patient Data Collection (APDC) to identify patients with a diagnostic code relating to chronic renal failure during any admission between 01/07/2000 and 31/07/2010. Both cohorts were linked to the NSW APDC, the Registry of Births, Deaths and Marriages, and the Central Cancer Registry allowing derivation of outcomes by categories of geographical remoteness. RESULTS To date, we have identified 10,505 patients with 2,384218 records in the end stage kidney disease cohort and 159,033 patients with 1,599,770 records in the chronic kidney disease cohort. DISCUSSION This study will define the geographical distribution of end stage and chronic kidney disease and compare the health service utilisation between rural and urban renal populations.

  • Supportive text messages to reduce mood symptoms and problem drinking in patients with primary Depression or Alcohol Use Disorder - protocol for an implementation research study

    Date Submitted: Feb 23, 2015

    Open Peer Review Period: Feb 24, 2015 - Mar 10, 2015

    Background: Depression and Alcohol Use Disorders (AUDs) are two leading causes of disability worldwide and are associated with significant treatment challenges requiring new, innovative, cost effectiv...

    Background: Depression and Alcohol Use Disorders (AUDs) are two leading causes of disability worldwide and are associated with significant treatment challenges requiring new, innovative, cost effective and technologically based therapies including the use of supportive text messages. Objective: To determine the feasibility and effectiveness of using supportive text messages in long-term follow-up to reduce mood symptoms and problem drinking in patients with Depression or AUD respectively and to explore the usefulness of self-reports of health services utilization as an outcomes measure. Methods: This will be a longitudinal, prospective, parallel design, two arm, placebo-controlled single-rater-blinded randomized clinical trial with a recruitment period of 6 months and an observation period of 12 months for each participant with two strata based on primary diagnosis of Major Depressive Disorder or AUD. The sample size will be 120, with about 60 patients randomised from each primary diagnostic grouping. Patients in all intervention groups will receive twice-daily supportive SMS text messages for 3 months and then daily supportive text messages for the next three months. Patients will also receive a phone call every two weeks from the research assistant assigning treatment allocation to confirm that they are still receiving the text messages and to thank them for taking part in the study. Patients in the control group will receive no text messages but will also receive a phone call from the same research assistant every two weeks to thank them for taking part in the study. Results: The study starts in April 2015 and ends in September 2016. It is envisaged that both qualitative and quantitative primary and secondary outcomes, including patient perceptions of the intervention will shed light on the feasibility of using automated supportive text message interventions in long term for patients with Depression and AUD. This will inform a full-scale clinical trial. Conclusions: The paradigm for behaviour change using text messages as a patient-direct intervention is consistent with a cognitive behaviour therapy approach and addictions counselling principles. Given the automaticity of the messages, we anticipate that if the intervention proves successful, it will represent a low cost strategy that will be readily available and can bring relief to patients in hard to reach areas with limited access to psychological therapies. Clinical Trial: ClinicalTrials.gov Identifier: NCT02327858

  • Depression awareness and self-management through the internet: An internationally standardised approach

    Date Submitted: Feb 19, 2015

    Open Peer Review Period: Feb 19, 2015 - Mar 5, 2015

    Background: Depression incurs significant morbidity and confers increased risk of suicide. Many individuals experiencing depression remain untreated due to systemic and personal barriers to care. Guid...

    Background: Depression incurs significant morbidity and confers increased risk of suicide. Many individuals experiencing depression remain untreated due to systemic and personal barriers to care. Guided internet-based psychotherapeutic programmes represent a promising means of overcoming such barriers and increasing the capacity for self-management of depression. However, existing programmes tend to be available only in English and can be expensive to access. Furthermore, despite evidence of the effectiveness of a number of internet-based programmes, there is limited evidence regarding both the acceptability of such programmes and feasibility of their use, for users and healthcare professionals. Objective: This paper will present the protocol for the development, implementation and evaluation of the iFightDepression internet-based self-management tool: a cost-free, multilingual, guided self-management programme for mild to moderate depression. Methods: The PREDI-NU (Preventing Depression and Improving Awareness through Networking in the EU) consortium undertook a comprehensive systematic review of the available evidence regarding computerised Cognitive Behaviour Therapy in addition to a consensus process involving mental health experts and service users to inform development of the iFightDepression tool. The tool was implemented in a pilot phase in five European regions, with recruitment of users occurring through general practitioners and healthcare professionals who participated in a standardised training programme. Evaluation included qualitative and quantitative data from both patients and professionals to assess the acceptability of the tool and feasibility of its use. This informed enhancement of the tool for a second phase of implementation. Results: Targeting mild to moderate depression, the iFightDepression tool is based on cognitive-behavioural therapy and addresses behavioural activation (monitoring and planning daily activities), cognitive restructuring (identifying and challenging unhelpful thoughts), sleep regulation, mood monitoring, and healthy lifestyle habits. There is also a tailored version of the tool for young people, incorporating less formal language and additional age-appropriate modules on relationships and social anxiety. The tool is accompanied by a 3-hour training intervention for healthcare professionals. Conclusions: It is intended that the iFightDepression tool and associated training for healthcare professionals will represent a valuable resource for the management of depression that will complement existing resources for healthcare professionals. It is also intended that the iFightDepression tool and training will represent an additional resource within a multifaceted approach to improving the care of depression and preventing suicide in Europe.