JMIR Research Protocols

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

Bringing feedback in from the outback via a generic and preference-sensitive instrument for course quality assessment

Background: Much effort and many resources has 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 invariably been disappointingly low and the results accepted to be potentially biased. Objective: An innovative approach to course assessment by students in the health professions is 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 online instrument MyCourseQuality (MCQ-10D) was developed following a purposive review of previous instruments. Shorthand labels for the criteria are: Content, Organisation, Perspective, Presentations, Materials, Relevance, Workload, Support, Interactivity, and Assessment. The assessment is unique in being dually-personalised. 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-personalised 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 enrolment, 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 two medical schools will establish the organisational feasibility and acceptability of the approach (a version of which has been employed in one school previously), as well as its impact on provider behaviour 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. Conclusions: We present a protocol for the piloting of a student-centred, dually-personalised course quality instrument that forms part of the assignment requirements and is therefore an integral part of the course.

2014-11-06

The year 2014 comes to an end - have you published enough in 2014 to keep your career moving ahead?

Add another paper to your 2014 publication list by publishing a grant proposal or protocol of your ongoing or planned research in our PubMed-indexed journal JMIR Res Protoc:

  • submit your protocol/proposal of your ongoing study to JMIR Res Protoc before Nov 15th, 2014, and if it is already reviewed/approved by your granting agency (attach review reports), WE GUARANTEE ACCEPTANCE/PUBLICATION BEFORE DEC 31, 2014, with FAST-TRACK FEES WAIVED (APF for already peer-reviewed proposals/protocols is $950)
  • NO SUBMISSION FEES for articles submitted to JMIR Res Protoc between Nov 6th-15th, 2014
  • for all studies published in JMIR Res Protoc, we offer a 20% discount on the APF if the subsequent full study results are published in a JMIR journal (this is a $490 value)
  • while many JMIR Res Protoc papers are from the field of ehealth, we publish protocols from all areas of medicine and health research, including wet lab science, systematic review protocols, clinical randomized trial protocols, qualitative study protocols, formative research such as usability studies etc.

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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:

  • Developing Community-Based Rehabilitation Programs for Musculoskeletal Diseases in Low-Income Areas of Mexico: The Community-Based Rehabilitation for...

    Abstract:

    Background: The negative impact of musculoskeletal diseases on the physical function and quality of life of people living in developing countries is considerable. This disabling effect is even more marked in low-socioeconomic communities within developing countries. In Mexico, there is a need to create community-based rehabilitation programs for people living with musculoskeletal diseases in low-socioeconomic areas. These programs should be directed to prevent and decrease disability, accommodating the specific local culture of communities. Objective: The objective of this paper is to describe a research protocol designed to develop, implement, and evaluate culturally sensitive community-based rehabilitation programs aiming to decrease disability of people living with musculoskeletal diseases in two low-income Mexican communities. Methods: A community-based participatory research approach is proposed, including multi and transdisciplinary efforts among the community, medical anthropology, and the health sciences. The project is structured in 4 main stages: (1) situation analysis, (2) program development, (3) program implementation, and (4) program evaluation. Each stage includes the use of quantitative and qualitative methods (mixed method program). Results: So far, we obtained resources from a Mexican federal agency and completed stage one of the project at Chankom, Yucatán. We are currently receiving funding from an international agency to complete stage two at this same location. We expect that the project at Chankom will be concluded by December of 2017. On the other hand, we just started the execution of stage one at Nuevo León with funding from a Mexican federal agency. We expect to conclude the project at this site by September of 2018. Conclusions: Using a community-based participatory research approach and a mixed method program could result in the creation of culturally sensitive community-based rehabilitation programs that promote community development and decrease the disabling effects of musculoskeletal diseases within two low-income Mexican communities.
  • Homepage of the SOULAGE-TAVIE website showing functions to determine patient profile and to start the intervention.

    Acceptability of a Web-Based and Tailored Intervention for the Self-Management of Pain After Cardiac Surgery: The Perception of Women and Men

    Abstract:

    Background: Approximately two thirds of adults undergoing cardiac surgery suffer from moderate to severe postoperative pain. Assisting patients with pain management is therefore critical to prevent its negative consequences. Information technologies have become part of our lifestyle and can facilitate the implementation of interventions to manage pain in a busy care setting. A computer-tailored and Web-based intervention—referred to as SOUtien à L’AutoGEstion-Traitement-Assistance Virtuelle Infirmière-Enseignement (SOULAGE-TAVIE)—for the self-management of pain was developed. Findings from a previous pilot randomized controlled trial (RCT) provided some evidence of the feasibility and preliminary effectiveness of this intervention in decreasing pain interference with a few postoperative activities and by modulating pain beliefs and analgesic intake. However, its acceptability from the patient’s perspective remains unclear. Moreover, the proportion of women is much lower in the cardiac surgical population, making it difficult to detect differences in experiences between men and women. Objective: The objectives were (1) to describe SOULAGE-TAVIE’s acceptability from the perspective of adults experiencing pain after cardiac surgery and (2) to compare the perceptions of men and women. Methods: A mixed-method approach was used to capture the various attributes of patients’ perceptions of the intervention’s acceptability and to compare the perceptions of men and women. Quota samples of men (n=10; mean age 62.5 years, SD 7.3) and women (n=10; mean age 64.3 years, SD 10.7) who had cardiac surgery in the past month were invited to view the intervention, complete a brief questionnaire rating its acceptability, and then to discuss each component in a 60-minute, semistructured interview. Mann-Whitney U tests were used to compare groups. The transcripts were content analyzed to generate themes based on patients’ experiences with the intervention and reports of acceptability. The content of each category and subcategory were compared between men and women. Frequency counts were also done to validate the emergence of a difference between the 2 subgroups. Results: Participants perceived the intervention to be very acceptable in terms of content and format, and tended to describe awareness-raising and convenient support experiences. Women scored higher than men in terms of the intervention’s appropriateness (U=13.5, P=.008). They were willing to adhere to the intervention based on the importance and relevance of the advice provided, whereas men were more focused on the delivery mode and its flexibility. Conclusions: This study underlined the acceptability of computer tailoring and persuasive communication to modulate pain beliefs and attitudes in an acute care context. Both men and women appreciated the Web-based interface and general self-guided approach of the intervention. The delivery of SOULAGE-TAVIE across the continuum of care seems to be an interesting avenue to influence the transition from acute to chronic postoperative pain.
  • The Library frontpage translated into English by Google Translate.

    Examining the Use of an Open Digital Health Library for Professionals

    Abstract:

    Background: The Norwegian Electronic Health Library (The Library) is a website for health personnel. Most of the content is also open to the public. Usage statistics have risen sharply in the years 2010-2013. Objective: We wanted to find out whether the rise was caused by health personnel, the general public, or other factors. Methods: Since we lacked direct information, we had to use proxy data to shed light on our questions. We applied mixed methods (database of registered users, user survey, usage statistics, and statistics from suppliers), and triangulated between them. Results: Health personnel were our largest user group, but The Library was also accessed by students, patients, and other groups. Content in Norwegian was preferred to English language content. Concise, practical information was preferred to more comprehensive information. Patient leaflets were the most popular information type. Mobile phone visits differed from personal computer visits both in terms of time of day and what kind of information was viewed. Conclusions: The Library was used mostly by health personnel, as intended, but our data are inconclusive regarding a possible change in user groups. There was a large degree of consistency in results when using different investigation methods. The survey points toward health personnel being the largest user group, and the usage statistics show that patient leaflets are the most popular content, being viewed by both health personnel and patients.
  • Screenshot of MijnSAB.

    An Online Health Community for Aneurysmal Subarachnoid Hemorrhage Patients: A Pilot Study

    Abstract:

    Background: Aneurysmal subarachnoid hemorrhage (aSAH) is a condition affecting relatively young patients and has high rates of morbidity and mortality. Online health communities have emerged to fill the void for patient advocacy and information, allowing individuals with shared experiences and chronic disorders to connect. Objective: We have developed an online health community for aSAH patients, and this pilot study was conducted to evaluate it from a patient’s perspective. Methods: We implemented an online, members-only, health community (MijnSAB, translation: MySAH) in addition to the usual aSAH care at Radboudumc, Nijmegen, the Netherlands. A questionnaire that was sent to consecutive aSAH patients was used to evaluate the usability and utility of MySAH. Answers were provided using a 5-point Likert scale. There was also one open-ended question asking about what was missing from the MySAH tool. Results: In total, 66 consecutive patients with aneurysmal subarachnoid hemorrhage were informed about the online health community. Of 64 potential MySAH users, 26 patients gained access to MySAH, 20 of whom were willing to participate in the evaluation. Those who used the community were younger (P=.03) and in a better condition at discharge (P=.03). The patients were positive about MySAH’s contribution to the quality of their care, but not to their quality of life. Most patients (18/20, 90%) reported that they would recommend the community to others in their position. Open suggestions on how to improve the tool included more frequent blogs, including by a rehabilitation specialist. Conclusions: This pilot study showed that the online health community, MySAH, has a beneficial effect on the aftercare of patients suffering from aSAH because it gives easy access to relevant information provided by peers or caregivers. Due to the variable clinical outcomes after aSAH, the tool will mainly be useful for a select group of patients (with a better clinical outcome).
  • Cropped Figure 2.

    A Formative Evaluation of a Social Media Campaign to Reduce Adolescent Dating Violence

    Abstract:

    Background: The Emory Jane Fonda Center implemented the Start Strong Atlanta social marketing campaign, “Keep It Strong ATL”, in 2007 to promote the development of healthy adolescent relationships and to foster the prevention of adolescent dating abuse among 11-14 year olds. Objective: A formative evaluation was conducted to understand whether messages directed at the target audience were relevant to the program’s relationship promotion and violence prevention goals, and whether the “Web 2.0” social media channels of communication (Facebook, Twitter, YouTube, Flickr, Tumblr, and Pinterest) were reaching the intended audience. Methods: Mixed methodologies included qualitative interviews and a key informant focus group, a cross-sectional survey, and web analytics. Qualitative data were analyzed using constant comparative methodology informed by grounded theory. Descriptive statistics were generated from survey data, and web analytics provided user information and traffic patterns. Results: Results indicated that the Keep It Strong ATL social marketing campaign was a valuable community resource that had potential for broader scope and greater reach. The evaluation team learned the importance of reaching adolescents through Web 2.0 platforms, and the need for message dissemination via peers. Survey results indicated that Facebook (ranked 6.5 out of 8) was the highest rated social media outlet overall, and exhibited greatest appeal and most frequent visits, yet analytics revealed that only 3.5% of “likes” were from the target audience. These results indicate that the social media campaign is reaching predominantly women (76.5% of viewership) who are outside of the target age range of 11-14 years. Conclusions: While the social media campaign was successfully launched, the findings indicate the need for a more focused selection of communication channels, timing of media updates to maximize visibility, balancing message tone and delivery, and incorporating differentiated messaging for the target audiences. Collaboration with parents and community partners is also emphasized in order to expand the campaign’s reach and create more channels to disseminate relationship promotion and dating violence prevention messaging to the intended audience.
  • By Kamnuan, published on 07 August 2014 Stock Photo - image ID: 100279614; http://www.freedigitalphotos.net/images/surreal-fruit-concept-photo-p279614.

    Comparison of Two Theory-Based, Fully Automated Telephone Interventions Designed to Maintain Dietary Change in Healthy Adults: Study Protocol of a Three-Arm...

    Abstract:

    Background: Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation. Objective: The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption. Methods: The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ≥1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance interventions are 6 months. All 405 participants who qualify for the trial will complete surveys administered by blinded interviewers at baseline (randomization), 6, 12, 18, and 24 months. Results: Data analysis is not yet complete, but we hypothesize that (1) TLC-GST > TLC-SCT > control at all follow-up time points for F&V consumption, and (2) intervention effects will be mediated by the theoretical constructs (eg, self-efficacy, goal pursuit, conflict, shielding, and facilitation). Conclusions: This study used a novel study design to initiate and then promote the maintenance of dietary behavior change through the use of an evidence-based fully automated telephony intervention. After the first 6 months (the acquisition phase), we will examine whether two telephony interventions built using different underlying behavioral theories were more successful than an assessment-only control group in helping participants maintain their newly acquired health behavior change. Clinical Trial: Clinicaltrials.gov NCT00148525; http://clinicaltrials.gov/ct2/show/NCT00148525 (Archived by Webcite at http://www.webcitation.org/6TiRriJOs).
  • Screenshot of a patient account from https://patienttime.nivel.nl/.

    Active Patient Participation in the Development of an Online Intervention

    Abstract:

    Background: An important and challenging part of living with cancer relates to the repeated visits to the hospital. Since how patients cope between these post-diagnostic visits depends partly on the information and support received from their physician during the visits, it is important to make the most of them. Recent findings reinforce the importance of training not only the health care professionals in communication skills, but providing patients with support in communication as well. Delivering such supportive interventions online can have potential benefits in terms of accessibility, cost-effectiveness, and ability to tailor information to personal needs. However, problems with attrition (dropout, non-usage) during the test phase and poor uptake after implementation are frequently reported. The marginal level of engagement of the patient as end user seems to play a role in this. Therefore, recent research suggests integrating theory-based development methods with methods that promote involvement of the patient at an early stage. This paper describes a participatory protocol, used to let patients guide a theory-informed development process. Objective: The objective of this project was to apply a bottom-up inspired procedure to develop a patient-centered intervention with corresponding evaluation and implementation plan. Methods: The applied development protocol was based on the intervention mapping framework, combined with patient participatory methods that were inspired by the participation ladder and user-centred design methods. Results: The applied protocol led to a self-directed online communication intervention aimed at helping patients gain control during their communications with health care professionals. It also led to an evaluation plan and an implementation plan. The protocol enabled the continuous involvement of patient research partners and the partial involvement of patient service users, which led to valuable insights and improvements. Conclusions: The applied protocol realized patient participation on different levels throughout the entire project. Early involvement, involvement on different levels, and flexibility in terms of planning and setup seem to be preconditions to creating a bottom-up inspired development procedure with (seriously ill) patients. Further research is necessary to find out if a more patient-centered approach improves the implementation and uptake of eHealth interventions. Clinical Trial: Netherlands National Trial Register ID number: NTR3779; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3779 (Archived by WebCite at http://www.webcitation.org/6TdfALKxV).
  • Thumbnail screenshot.

    Treatment of Infantile Hemangioma in Regional Hospitals With eHealth Support: Evaluation of Feasibility and Acceptance by Parents and Doctors

    Abstract:

    Background: Since beta blockers became the preferred treatment for infantile hemangiomas (IH), the number of patients eligible for treatment is increasing. Currently treatment of IH with beta blockers is mainly reserved for expert centers, where wait times are lengthening. This demonstrated the need for development of a more efficient and accessible way of providing care for children needing treatment for IH. An eHealth intervention, Hemangioma Treatment Plan (HTP), was developed to treat IH in regional hospitals with online support from an academic doctor. Objective: Our goal was to evaluate the feasibility of the eHealth intervention by determining its use, acceptance, and usability. By evaluating the feasibility, usage can be predicted and points for improvement can be defined, thereby facilitating implementation of the intervention. Methods: Parents of children with an IH, presenting between October 2012 and November 2013 at the tertiary expert Center for Congenital Vascular Anomalies Utrecht, requiring treatment with a beta blocker, were asked to participate in the digital HTP. Both parents and regional doctors were sent a study questionnaire. Acceptance and usability of the HTP were evaluated by using the modified Technology Acceptance Model. Results: A total of 31 parents and 22 regional doctors participated in the eHealth intervention and received the questionnaire, and 25 parents and 15 doctors responded (response rates respectively 81% and 68%). A majority of the parents (96%, 24/25) and the regional doctors (87%, 13/15) considered the eHealth intervention useful in the care for IH. Most parents (76%, 19/25) and over half of the regional doctors (53%, 8/15) found the HTP easy to use. Technical problems using the HTP were reported by 28% (7/25) of the parents and 73% (11/15) of the doctors. The majority of parents (92%, 23/25) felt positive about usage of the HTP during treatment of their child. All regional doctors (100%, 15/15) felt positive about transition of treatment from the tertiary expert center to them, and 93% (14/15) felt positive about using the HTP. Conclusions: Our eHealth intervention shows good feasibility, especially among parents. Improvement with respect to technical problems, training of regional doctors, and achieving organizational support might be needed for successful implementation in the future.
  • Zoom from Figure 1.

    The Evolution of a Professional Practice Forum: Balancing Peer-to-Peer Learning With Course Objectives

    Abstract:

    Background: The Opioid Treatment Accreditation Course (OTAC) is a mandatory accreditation requirement in New South Wales, Australia, and aims to prepare medical practitioners for the provision of safe and effective Opioid Substitution Treatment to people with opioid dependence. The course has a strong focus on safe prescribing practices and the course design includes a Professional Practice Forum that is engaging for participants and effective at imparting complex ideas and concepts that do not place additional time constraints on already time-poor health professionals. Objective: The study aimed to use participatory action research methods to develop and evaluate an online Professional Practice Forum that is a key component of the OTAC teaching and learning experience. Methods: Three evaluation cycles were implemented with three cohorts of participants (N=40) to inform the design and review of the updated OTAC course. Overall, the study relied on participatory action research methods to enhance a sense of online community and to revise the Professional Practice Forum component of the course. Findings from survey feedback and an examination of Web metrics were used to monitor participant learning and were subsequently subject to thematic analysis in order to identify key themes. Results: The use of participatory action techniques in the redesign of the OTAC course was a successful means of engaging with participants and resulted in four revisions based on feedback from facilitators and participants. The Professional Practice Forum was rated highly and received positive feedback from both moderators and participants. Conclusions: The use of interactive forums in online learning in an educational module for adult learners can prove extremely valuable as a means for participants to share their expertise and improve their learning outcomes. In particular, the use of sticky and welcome threads were significant features that enhanced interactions between participants and facilitators and resulted in increased quantity and quality of postings. These findings can help inform future researchers on how to develop peer engagement modules that are amenable to assessment and that build an online sense of community.
  • TOC image created for trial by TRW.

    Promoting Physical Activity in Low-Active Adolescents via Facebook: A Pilot Randomized Controlled Trial to Test Feasibility

    Abstract:

    Background: The World Wide Web is an effective method for delivering health behavior programs, yet major limitations remain (eg, cost of development, time and resource requirements, limited interactivity). Social media, however, has the potential to deliver highly customizable and socially interactive behavioral interventions with fewer constraints. Thus, the evaluation of social media as a means to influence health behaviors is warranted. Objective: The objective of this trial was to examine and demonstrate the feasibility of using an established social networking platform (ie, Facebook) to deliver an 8 week physical activity intervention to a sample of low-active adolescents (N=21; estimated marginal mean age 13.48 years). Methods: Participants were randomized to either an experimental (ie, Behavioral) or attentional control (ie, Informational) condition. Both conditions received access to a restricted-access, study-specific Facebook group where the group’s administrator made two daily wall posts containing youth-based physical activity information and resources. Primary outcomes included physical activity as assessed by accelerometry and self-report. Interactions and main effects were examined, as well as mean differences in effect sizes. Results: Analyses revealed significant improvements over time on subjectively reported weekly leisure-time physical activity (F1,18=8.426, P=.009, η2 = .319). However, there was no interaction between time and condition (F1,18=0.002, P=.968, η2 = .000). There were no significant time or interaction effects among the objectively measured physical activity variables. Examination of effect sizes revealed moderate-to-large changes in physical activity outcomes. Conclusions: Results provide initial support for the feasibility of delivery of a physical activity intervention to low-active adolescents via social media. Whether by employing behavioral interventions via social media can result in statistically meaningful changes in health-related behaviors and outcomes remains to be determined. Clinical Trial: ClinicalTrials.gov NCT01870323; http://clinicaltrials.gov/show/NCT01870323 (Archived by WebCite at http://www.webcitation.org/6SUTmSeZZ).
  • (cc) Patrick-Miller et al. CC-BY-SA 2.0, please cite as (http://www.researchprotocols.org/article/viewFile/3337/1/47432).

    Development of a Communication Protocol for Telephone Disclosure of Genetic Test Results for Cancer Predisposition

    Abstract:

    Background: Dissemination of genetic testing for disease susceptibility, one application of “personalized medicine”, holds the potential to empower patients and providers through informed risk reduction and prevention recommendations. Genetic testing has become a standard practice in cancer prevention for high-risk populations. Heightened consumer awareness of “cancer genes” and genes for other diseases (eg, cardiovascular and Alzheimer’s disease), as well as the burgeoning availability of increasingly complex genomic tests (ie, multi-gene, whole-exome and -genome sequencing), has escalated interest in and demand for genetic risk assessment and the specialists who provide it. Increasing demand is expected to surpass access to genetic specialists. Thus, there is urgent need to develop effective and efficient models of delivery of genetic information that comparably balance the risks and benefits to the current standard of in-person communication. Objective: The aim of this pilot study was to develop and evaluate a theoretically grounded and rigorously developed protocol for telephone communication of BRCA1/2 (breast cancer) test results that might be generalizable to genetic testing for other hereditary cancer and noncancer syndromes. Methods: Stakeholder data, health communication literature, and our theoretical model grounded in Self-Regulation Theory of Health Behavior were used to develop a telephone communication protocol for the communication of BRCA1/2 genetic test results. Framework analysis of selected audiotapes of disclosure sessions and stakeholders’ feedback were utilized to evaluate the efficacy and inform refinements to this protocol. Results: Stakeholder feedback (n=86) and audiotapes (38%, 33/86) of telephone disclosures revealed perceived disadvantages and challenges including environmental factors (eg, non-private environment), patient-related factors (eg, low health literacy), testing-related factors (eg, additional testing needed), and communication factors (eg, no visual cues). Resulting modifications to the communication protocol for BRCA1/2 test results included clarified patient instructions, scheduled appointments, refined visual aids, expanded disclosure checklist items, and enhanced provider training. Conclusions: Analyses of stakeholders’ experiences and audiotapes of telephone disclosure of BRCA1/2 test results informed revisions to communication strategies and a protocol to enhance patient outcomes when utilizing telephone to disclose genetic test results.
  • Intervention screenshot.

    A Virtual World Versus Face-to-Face Intervention Format to Promote Diabetes Self-Management Among African American Women: A Pilot Randomized Clinical Trial

    Abstract:

    Background: Virtual world environments have the potential to increase access to diabetes self-management interventions and may lower cost. Objective: We tested the feasibility and comparative effectiveness of a virtual world versus a face-to-face diabetes self-management group intervention. Methods: We recruited African American women with type 2 diabetes to participate in an 8-week diabetes self-management program adapted from Power to Prevent, a behavior-change in-person group program for African Americans with diabetes or pre-diabetes. The program is social cognitive theory–guided, evidence-based, and culturally tailored. Participants were randomized to participate in the program via virtual world (Second Life) or face-to-face, both delivered by a single intervention team. Blinded assessors conducted in-person clinical (HbA1c), behavioral, and psychosocial measurements at baseline and 4-month follow-up. Pre-post differences within and between intervention groups were assessed using t tests and chi-square tests (two-sided and intention-to-treat analyses for all comparisons). Results: Participants (N=89) were an average of 52 years old (SD 10), 60% had ≤high school, 82% had household incomes P=.90). Compared to face-to-face, virtual world was slightly superior for total activity, light activity, and inactivity (P=.05, P=.07, and P=.025, respectively). HbA1c reduction was significant within face-to-face (−0.46, P=02) but not within virtual world (−0.31, P=.19), although there were no significant between group differences in HbA1c (P=.52). In both groups, 14% fewer patients had post-intervention HbA1c ≥9% (virtual world P=.014; face-to-face P=.002), with no significant between group difference (P=.493). Compared to virtual world, face-to-face was marginally superior for reducing depression symptoms (P=.051). The virtual world intervention costs were US $1117 versus US $931 for face-to-face. Conclusions: It is feasible to deliver diabetes self-management interventions to inner city African American women via virtual worlds, and outcomes may be comparable to those of face-to-face interventions. Further effectiveness research is warranted. Clinical Trial: ClinicalTrials.gov NCT01340079; http://clinicaltrials.gov/show/NCT01340079 (Archived by WebCite at http://www.webcitation.org/6T2aSvmka).

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  • Bringing feedback in from the outback via a generic and preference-sensitive instrument for course quality assessment

    Date Submitted: Nov 18, 2014

    Open Peer Review Period: Nov 18, 2014 - Dec 2, 2014

    Background: Much effort and many resources has been put into developing ways of eliciting valid and informative student feedback on courses in medical, nursing, and other health professional schools....

    Background: Much effort and many resources has 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 invariably been disappointingly low and the results accepted to be potentially biased. Objective: An innovative approach to course assessment by students in the health professions is 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 online instrument MyCourseQuality (MCQ-10D) was developed following a purposive review of previous instruments. Shorthand labels for the criteria are: Content, Organisation, Perspective, Presentations, Materials, Relevance, Workload, Support, Interactivity, and Assessment. The assessment is unique in being dually-personalised. 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-personalised 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 enrolment, 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 two medical schools will establish the organisational feasibility and acceptability of the approach (a version of which has been employed in one school previously), as well as its impact on provider behaviour 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. Conclusions: We present a protocol for the piloting of a student-centred, dually-personalised course quality instrument that forms part of the assignment requirements and is therefore an integral part of the course.

  • A framework to assess the role of adoption and usage of mHealth technology on quality and experience of care provided by frontline workers: observations from rural Bihar

    Date Submitted: Nov 15, 2014

    Open Peer Review Period: Nov 18, 2014 - Dec 2, 2014

    Background: mHealth applications are deployed with the aim of improveing access, quality and experience of health care. It is possible that any mHealth intervention can yield differential impacts for...

    Background: mHealth applications are deployed with the aim of improveing access, quality and experience of health care. It is possible that any mHealth intervention can yield differential impacts for different types of users. Mediating and determining factors, including personal and socio-economic factors affect technology adoption, the way the health workers leverage and use the technology, and subsequently the quality and experience of care they provide. Objective: To develop a framework to assess whether mHealth platforms affect the quality and experience care provided by frontline workers, and whether these effects on quality and experience are different depending on the level of technology adoption and individual characteristics of the health worker. Literacy, education, age, and previous mobile experience are identified as individual factors that affect technology adoption and use, as well as factors that affect the quality and experience of care directly and via the technology. Methods: Formative research with 14 community health workers (CHW) using CommCare, a mHealth application for maternal and new born care, in Bihar, India. CHWs are first classified on level of CommCare adoption using data from CommCareHQ and then shadowed on home visits to evaluate their levels of technology proficiency, and the quality and experience of care provided. Regression techniques are employed to test the relationships. Results: Level of technology adoption is important for both quality and experience of care. The quality score for high users of CommCare is higher by 33.4% (P=.036) on average compared to low users of CommCare. Those who score higher on CommCare proficiency, also provide significantly higher quality and experience of care, where an additional point in CommCare proficiency score, increases quality score by around half a point (.541, P=.069), and experience score by around a third of a point (.308, P=.032). Compared to low-literate CHWs, illiterate CHWs have lower CommCare proficiency and usage scores, with illiteracy decreasing the CommCare proficiency score by 41% compared to lower literacy (P=0.087). Compared to literate ASHAS, illiterate ASHAs have a CommCare proficiency score that is lower by 51% (P=0.072). Age affects CommCare user-type negatively, with increasing in age increasing the likelihood of belonging to a lower category of CommCare adoption (-.105, P=.076). Predicted values estimating the relationship between CommCare proficiency and quality of care are negatively affected for those that are illiterate compared to those that are lower literate (-4.95, P=.087). Similarly, predicted values estimating the relationship between CommCare proficiency and experience of care are negatively affected, for those that are illiterate compared to those that are lower literate (-2.815, P=.087). Conclusions: mHealth technology adoption by frontline workers can positively impact the quality and experience of care they provide. Individual characteristics, especially literacy and age can be an important element affecting technology adoption, and the way users leverage the technology for their work. Our formative study provides informed hypothesis and methods for further research. Clinical Trial: None

  • A shared mealtime approach to improving social and nutritional functioning among older adults living alone (RelAte): study protocol for a randomised controlled trial

    Date Submitted: Nov 17, 2014

    Open Peer Review Period: Nov 18, 2014 - Dec 2, 2014

    Background: Background: Older adults living alone are at increased risk of malnutrition as well as social isolation. Previous research has evaluated psychosocial interventions aimed at improving socia...

    Background: Background: Older adults living alone are at increased risk of malnutrition as well as social isolation. Previous research has evaluated psychosocial interventions aimed at improving social support for older adults living alone. One meta-analysis in particular has suggested that multimodal psychosocial interventions are more effective than unimodal interventions. As such it may be more effective to deliver an intervention which combines nutritional and social support together. Consequently, we designed the RelAte intervention, which focuses on shared mealtimes as a source of combined social and nutritional support for older adults living alone who are at risk of social isolation. Objective: Objective: The RelAte Trial was designed to evaluate the impact of such an intervention on energy intake, anthropometric measurements, and nutritional social cognitive variables among older adults living alone in the community. Methods: Methods/Design: 100 participants will be recruited and randomised to either the treatment (n = 50) or the control group. The treatment group will receive a visit from a trained peer volunteer once weekly for a period of 8 weeks. Outcomes of interest include: energy intake, social cognitive factors related to diet, abdominal circumference, body mass index, psychosocial wellbeing, frailty, nutritional status, and health utilities. Outcomes will be obtained at baseline, immediately post-intervention (8 weeks after baseline), 12-week follow-up, and 26-week follow-up, by assessors blinded to participants’ randomised assignment. Conclusions: Discussion: Results from this study will primarily describe the effectiveness of a shared mealtime intervention for older adults living alone in terms of their dietary wellbeing, physical health, and psychosocial wellbeing. Clinical Trial: Trial Registration: Clinical Trials (clinicaltrials.gov) NCT02007551

  • Alive-PD fully automated web- and internet-based diabetes prevention program: Program design and randomized controlled trial protocol

    Date Submitted: Nov 17, 2014

    Open Peer Review Period: Nov 18, 2014 - Dec 2, 2014

    Background: Eighty-six million U.S. adults have pre-diabetes. Evidence-based interventions which are cost effective and widely scalable are needed to prevent diabetes. Objective: To develop a fully au...

    Background: Eighty-six million U.S. adults have pre-diabetes. Evidence-based interventions which are cost effective and widely scalable are needed to prevent diabetes. Objective: To develop a fully automated diabetes prevention program, and determine its effectiveness in a randomized controlled trial. Methods: Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly-developed one-year fully-automated behavior change program delivered by email and web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying smartphone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, BMI, weight, waist circumference and blood pressure at 3, 6, 9 and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results: A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or Delayed-entry Control Group (n=176). Baseline characteristics were as follows (mean (SD)): age 55 (8.9)y; BMI 31.1 (4.3); male 68.5%; fasting glucose 109.9 ± 8.4 mg/dL; HbA1c 5.6 ± 0.3 %. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post-baseline. Conclusions: The randomized trial will provide rigorous evidence regarding the efficacy of this web- and internet-based program in reducing or preventing progression of glycemic markers, and indirectly in preventing progression to diabetes. Clinical Trial: ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062. Accessed: 2014-11-16. (Archived by WebCite® at http://www.webcitation.org/6U8ODy1vo)

  • Simulation Of Direct Exchange Of Monitoring Information Between A Personalized Mobile App And The Ehr For Patients With Congestive Heart Failure: A Research Project Proposal

    Date Submitted: Nov 15, 2014

    Open Peer Review Period: Nov 18, 2014 - Dec 2, 2014

    Background: Mobile health applications (mHealth apps) for consumer health informatics are opening the way to patients’ responsible and active contribution to their healthcare management. However, ap...

    Background: Mobile health applications (mHealth apps) for consumer health informatics are opening the way to patients’ responsible and active contribution to their healthcare management. However, apart from Apps allowing patient’s access to their electronic health records (EHRs), mHealth apps are currently developed as dedicated “island systems” relying on ad-hoc repositories, specific access policies that require information duplicated in the patient’s EHR. Conversely, the clinician’s daily practice is based on EHR systems with minimal or no patient interaction from home. Objective: This project aims to test the feasibility of the integration between an mHealth App for congestive heart failure patient’s monitoring and the patient’s EHR by simulating the integration environment using an open-access EHR system. Methods: As a first step, we will review the current literature and standards to define the conceptual framework for the integration of requirements of the mHealth app/EHR exchange. From these, we will design the preliminary architecture of the EHR/mHealth app integrated system. To do so, we will first model through the Unified Modeling Language (UML) the process of home monitoring for patients with congestive heart failure, and then we will identify the building blocks for the system architecture responding to the requirements. The development of the EHR side prototype will be based on OpenMRS, an open source initiative that implements a longitudinal EHR. OpenMRS allows the development of customized forms and modules to support the simulated integration environment. The mHealth app for the patients and their caregiver will be developed for the iOS platform, with the contribution of domain experts in the interface design phase. The testing phase will be devoted to assess the feasibility of the approach. Results: We defined the main requirements for mHealth Apps/EHR exchange process as: (1) accurate information representation - ensuring the proper concept mapping from the patient/family domain to the healthcare domain; (2) data protection - considering the patient’s mobile device as an “unsafe” environment; (3) patient education - increasing the degree of trust of information generated by Apps; (4) information tracking - prompt evidence-based research on mHealth Apps adoption. From these, we designed an integration architecture based on the exchange of standard clinical documents, to ensure data accuracy, and implementing only the exchange of de-identified data. The interface of the system prototype was also developed. Conclusions: This project, if successful, will represent a step forward in the integration of personal mHealth apps into the larger health-IT ecosystem envisaged by HIE thus supporting the patient’s engagement in self-management and self-care and, ultimately, allowing better care and preventing frequent re-admissions.

  • Promoting effective homecare and telemonitoring for patients with implanted deep brain stimulation systems through integrated solutions for family caregivers

    Date Submitted: Nov 15, 2014

    Open Peer Review Period: Nov 17, 2014 - Dec 1, 2014

    Background: The increasing number of patient, the high costs of management, and the chronic progress of the disease that prevents patients to perform even simple daily activities, make Parkinson's Dis...

    Background: The increasing number of patient, the high costs of management, and the chronic progress of the disease that prevents patients to perform even simple daily activities, make Parkinson's Disease (PD) a complex pathology with high impact on society. In particular, patients implanted with Deep Brain Stimulation (DBS) electrodes face a highly fragile stabilization period, requiring specific support at home. However, DBS patients are followed usually by untrained personnel (caregivers or family), without specific care pathways and supporting systems. Objective: This projects aims to (1) Create a reference consensus guideline and a shared requirement set for the homecare and monitoring of DBS patients; (2) Define a set of biomarkers that provide alarms to caregivers for continuous home monitoring; (3) Implement an information system architecture allowing the communication between healthcare professionals and caregivers, and supporting the improvement of the quality of care for DBS patients. Methods: The definition of the consensus care pathway and of caregivers' needs will be carried out by analyzing the current practices for patient’s follow up through focus groups and structured interviews involving healthcare professionals, patients, and caregivers. The results of this analysis will be represented in a formal graphical model of the process of DBS patients' care at home. To define the neurophysiological biomarkers to be used to raise alarms during the monitoring process, neurosignals will be acquired from DBS electrodes through a new experimental system that records while DBS is turned ON and transmits signals by radiofrequency. Motor, cognitive, and behavioural protocols will be used to study possible feedback/alarm to be provided by the system. Finally, a set of mobile applications to support the caregiver at home in managing and monitoring the patient will be developed and tested in the community of caregivers that participated to the focus groups. The set of developed applications will be connected to the already-existing WebBioBank system allowing the healthcare professionals to manage patients’ electronic health records and neurophysiological signals. New modules in the WebBioBank system will be implemented to allow the integration and data exchange with the mobile health applications. Results: The results of this project will provide a novel approach to long term evaluation of patients with chronic, highly severe condition, in the homecare environment based on caregiver empowerment and tailored applications developed according to consensus care pathways established by clinicians. Conclusions: The creation of a direct communication channel between healthcare professionals and caregivers can benefit large communities of patients, and would represent a scalable experience in integrating data and information coming from a clinical setting to those from home monitoring.