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JMIR Research Protocols

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

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Journal Description

 

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

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

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

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

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

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

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

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

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

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

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

 
 

Recent Articles:

  • A mother with her child with autism spectrum disorder. Source: Aliya Naheed; Copyright: Shehzad Noorani/HMS Center for Global Health Delivery-Dubai; URL: http://www.researchprotocols.org/2017/12/e251/; License: Creative Commons Attribution (CC-BY).

    Implementing a Mental Health Care Program and Home-Based Training for Mothers of Children With Autism Spectrum Disorder in an Urban Population in Bangladesh:...

    Abstract:

    Background: Mothers of children with autism spectrum disorder (ASD) have reported a higher level of depression than mothers of children with other neurodevelopmental disorders in both developed and developing countries. Mothers are the lifetime caregivers of children with ASD, and a high burden of depression can negatively impact their ability to provide care. However, access to mental health services in primary care is limited, given the scarcity of qualified providers in Bangladesh. Objective: We aim to pilot the feasibility of integrating mental health services for the mothers of children with ASD attending schools offering ASD care and improve skills of mothers for child care through a home-based training program. Methods: The study will be conducted in two selected schools in Dhaka in Bangladesh that have been offering services for ASD for more than 10 years. A female psychologist will be deployed at the schools to offer nonpharmacological services for all mothers having a depressive episode. Referral for pharmacological treatment will be made at the discretion of supervising psychiatrists. An ASD special educator will provide training to the mothers for enhancing their child care skills at home on a monthly basis. The proposed intervention package will be implemented over a period of 4-6 months, and the feasibility of the intervention will be assessed through a pre- and postintervention evaluation by obtaining the perspectives of various stakeholders involved in the implementation of mental health services and maternal training. The primary outcome will include assessment of acceptability, adaptability, demand, practicality, implementation, and integration of the package intervention in the school settings. The secondary outcomes will include assessment of: 1) the prevalence of maternal depression; 2) children’s behavioral, social, and communication skills; and 3) the intervention participation costs incurred by institutions and families. Results: Between February and March 2017, 188 mothers of children with ASD were screened for depression following a written informed consent. Based on the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), the Structured Clinical Interview for the DSM-IV (SCID-1) was administered to 66 mothers. In-depth interviews were conducted with 10 mothers and 8 various stakeholders. Between January-June 2017, the team finalized a draft psychosocial counseling module and a maternal training module. Between April-May 2017, mental health services were provided by psychologists to 41 mothers who attended the counseling centers at each school. Three special educators have been trained in June 2017 to initiate training of the participating mothers. Conclusions: This is the first study of a mental health intervention for mothers of children with ASD to reduce their burden of depression and improve the outcomes of their children. The findings will inform the provision of services for children with ASD and their mothers in Bangladesh and similar settings.

  • GIRLS Study Logo. Source: Image created by the Authors; Copyright: Nok Chhun; URL: http://www.researchprotocols.org/2017/11/e179/; License: Creative Commons Attribution (CC-BY).

    High-Yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS Study): Implementation Science Protocol for a Priority...

    Abstract:

    Background: Sub-Saharan Africa is the region with the highest HIV burden. Adolescent girls and young women (AGYW) in the age range of 15 to 24 years are twice as likely as their male peers to be infected, making females in sub-Saharan Africa the most at-risk group for HIV infection. It is therefore critical to prioritize access to HIV testing, prevention, and treatment for this vulnerable population. Objective: Using an implementation science framework, the purpose of this research protocol was to describe the approaches we propose to optimize engagement of AGYW in both the HIV prevention and care continuum and to determine the recruitment and testing strategies that identify the highest proportion of previously undiagnosed HIV infections. Methods: We will compare two seek recruitment strategies, three test strategies, and pilot adaptive linkage to care interventions (sequential multiple assignment randomized trial [SMART] design) among AGYW in the age range of 15 to 24 years in Homa Bay County, western Kenya. AGYW will be recruited in the home or community-based setting and offered three testing options: oral fluid HIV self-testing, staff-aided rapid HIV testing, or referral to a health care facility for standard HIV testing services. Newly diagnosed AGYW with HIV will be enrolled in the SMART trial pilot to determine the most effective way to support initial linkage to care after a positive diagnosis. They will be randomized to standard referral (counseling and a referral note) or standard referral plus SMS text message (short message service, SMS); those not linked to care within 2 weeks will be rerandomized to receive an additional SMS text message or a one-time financial incentive (approximately US $4). We will also evaluate a primary prevention messaging intervention to support identified high-risk HIV-negative AGYW to reduce their HIV risk and adhere to HIV retesting recommendations. We will also conduct analyses to determine the incremental cost-effectiveness of the seek, testing and linkage interventions. Results: We expect to enroll 1200 participants overall, with a random selection of 100 high-risk HIV-negative AGYW for the SMS prevention intervention (HIV-negative cohort) and approximately 108 AGYW who are living with HIV for the SMART design pilot of adaptive linkage to care interventions (HIV-positive cohort). We anticipate that the linkage to care interventions will be feasible and acceptable to implement. Lastly, the use of SMS text messages to engage participants will provide pilot data to the Kenyan government currently exploring a national platform to track and support linkage, adherence to treatment, retention, and prevention interventions for improved outcomes. Conclusions: Lessons learned will inform best approaches to identify new HIV diagnoses to increase AGYW’s uptake of HIV prevention, testing, and linkage to care services in a high HIV-burden African setting. Clinical Trial: ClinicalTrials.gov NCT02735642; https://clinicaltrials.gov/ct2/show/NCT02735642 (Archived by WebCite at http://www.webcitation.org/6vgLLHLC9)

  • A person with scapular dyskinesis. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/11/e240/; License: Creative Commons Attribution (CC-BY).

    The Effectiveness of Exercise Therapy on Scapular Position and Motion in Individuals With Scapular Dyskinesis: Systematic Review Protocol

    Abstract:

    Background: Scapular dyskinesis is an alteration in normal scapular position and motion. Some researchers believe that altered kinematics of the scapula subsequent to dysfunction or weakness of scapular stabilizing muscles contributes to impingement syndrome. Scapular muscle exercises are included in the rehabilitation of patients with subacromial impingement syndrome and scapular dyskinesis because the muscular system is one of the major contributors of scapular positioning both at rest and during shoulder movement, but there is considerable uncertainty relating to the relative effectiveness of such approaches on changing scapular position and motion. Objective: The aim of this systematic review protocol is to evaluate the effectiveness of exercise therapy on scapular position and motion in individuals with scapular dyskinesis. Methods: A systematic review will be conducted using PubMed, Scopus, Web of Science, Elsevier, Ovid, ProQuest, Physiotherapy Evidence Database, and Cochrane Library. The reference lists of articles, other reviews, gray literature, and key journals will be searched for relevant articles. Clinical trials reporting the effect of therapeutic exercises (scapular strengthening exercise, scapular stabilization exercise, scapular muscle stretching) with the aims of changing scapular position and motion in individuals with scapular dyskinesis will be included. Two independent reviewers will select studies, extract data, and assess the quality of primary studies. Any disagreement during the selection of studies will be discussed and decided by the whole team. Results: This systematic review began in December 2016 and is currently in progress. The findings will be synthesized to determine the effectiveness of recommended therapeutic exercise on scapular position and motion in individuals with scapular dyskinesis. Conclusions: This is the first systematic review protocol aiming to assess the effectiveness of exercise therapy in individuals with scapular dyskinesis. The systematic review doesn’t require ethics approval because all data used will be provided from published documents. The results of this study will be published in a peer-reviewed journal. Trial Registration: PROSPERO CRD42017053923; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=53923 (Archived by WebCite at http://www.webcitation.org/6uzq32T02)

  • mDiab study logo. Source: Image created by Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/12/e242/; License: Creative Commons Attribution (CC-BY).

    Mobile Health Technology (mDiab) for the Prevention of Type 2 Diabetes: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: The prevalence of type 2 diabetes is increasing in epidemic proportions in low- and middle-income countries. There is an urgent need for novel methods to tackle the increasing incidence of diabetes. The ubiquity of mobile phone use and access to Internet makes mobile health (mHealth) technology a viable tool to prevent and manage diabetes. Objective: The objective of this randomized controlled trial is to implement and evaluate the feasibility, cost-effectiveness, and sustainability of a reality television–based lifestyle intervention program. This intervention program is delivered via a mobile phone app (mDiab) to approximately 1500 Android smartphone users who are adults at a high risk for type 2 diabetes from three cities in India, namely, Chennai, Bengaluru, and New Delhi. Methods: The mDiab intervention would be delivered via a mobile phone app along with weekly coach calls for 12 weeks. Each participant will go through a maintenance phase of 6 to 8 months post intervention. Overall, there would be 3 testing time points in the study: baseline, post intervention, and the end of follow-up. The app will enable individuals to track their weight, physical activity, and diet alongside weekly video lessons on type 2 diabetes prevention. Results: The study outcomes are weight loss (primary measure of effectiveness); improvement in cardiometabolic risk factors (ie, waist circumference, blood pressure, glucose, insulin, and lipids); and improvement in physical activity, quality of life, and dietary habits. Sustainability will be assessed through focus group discussions. Conclusions: If successful, mDiab can be used as a model for translational and implementation research in the use of mHealth technology for diabetes prevention and may be further expanded for the prevention of other noncommunicable diseases such as hypertension and cardiovascular diseases. Trial Registration: Clinical Trials Registry of India CTRI/2015/07/006011 http://ctri.nic.in/Clinicaltrials/pdf_generate.php? trialid=11841 (Archived by WebCite at http://www.webcitation.org/6urCS5kMB)

  • Source: Pixabay; Copyright: William Iven; URL: https://pixabay.com/en/office-freelancer-computer-business-625893/; License: Public Domain (CC0).

    Participant-Centric Initiatives and Medical Research: Scoping Review Protocol

    Abstract:

    Background: Significant advances in digital technologies have meant that health care data can be collected, stored, transferred, and analyzed for research purposes more easily than ever before. Participant-centric initiatives (PCI) are defined as “tools, programs, and projects that empower participants to engage in the research process” using digital technologies and have the potential to provide a number of benefits to both participants and researchers, including the promotion of public trust in medical research, improved quality of research, increased recruitment and retention, and improved health care delivery. Objective: The main objective of this scoping review is to describe the extent and range of PCIs across the United Kingdom, United States, and Japan that are designed to facilitate medical research. Methods: The methodological framework described by Levac et al will be applied to this scoping review. We will search electronic databases (MEDLINE, EMBASE, PsychINFO, Cumulative Index to Nursing, and Allied Health Literature and CiNii), grey literature sources, Internet search engines (Google and Bing), and hand search key journals and reference lists of relevant articles. All digital tools and programs will be eligible for inclusion if there is a description of key features and functions that fall within the parameters of a PCI. Only those that play a role in medical research will be included. Results: Preliminary searches conducted in MEDLINE and EMBASE retrieved 1820 and 2322 results, respectively. The scoping review will be completed by January 2018. Conclusions: The scoping review will be the first to map the extent and range of PCIs currently available across the United Kingdom, United States, and Japan, and will be the first review to contribute to a better understanding of what PCIs patients may benefit from. Researchers and practitioners will be able to use information in this review as a guide for patients and also as a guide for the development of future tools and programs. The results will be disseminated through a peer-reviewed publication and conference presentations.

  • Men in group therapy. Source: Image created by the Authors; Copyright: Etheldreda Nakimuli-Mpungu; URL: http://www.researchprotocols.org/2017/12/e250/; License: Creative Commons Attribution (CC-BY).

    The Effect of Group Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment Among People with HIV in Uganda: Protocol of a...

    Abstract:

    Background: There is limited information on the effectiveness of task shifting of mental health services in populations with HIV. Objective: This trial aims to evaluate the effectiveness of group support psychotherapy delivered by trained lay health workers to persons living with HIV (PLWH) with depression in primary care. Methods: Thirty eligible primary care health centers across three districts were randomly allocated to have their lay health workers trained to deliver group support psychotherapy (intervention arm) or group HIV education and treatment as usual (control arm) to PLWH with depression. Treated PLWH will be evaluated at baseline, after the end of treatment, and at 6-month intervals thereafter for 2 years. Primary outcomes will be the difference in follow-up proportions of participants with Mini International Neuropsychiatric Interview criteria for major depression and difference in follow-up function scores of participants in the intervention and control arms 6 months after the end of treatment. Secondary outcomes will include measures of self-esteem, posttraumatic stress symptoms, social support, stigma, adherence to antiretroviral therapy, viral load, and number of disability days, asset possession indices, and cost-effectiveness data. Primary and secondary outcomes as well as subgroup analyses will be conducted at the individual level using multilevel random effects regression analyses adjusting for clustering in health centers. A process evaluation using mixed methods to assess acceptability, feasibility, fidelity, causal mediating processes, and contextual influences in the trial will be conducted. Results: The trial has been approved by the Makerere College of Health Sciences School of Health Sciences Research Ethics Committee, the AIDS Support Organization, and the Uganda National Council of Science and Technology. A data and safety monitoring board has been put in place to monitor trial progress. A total of 1140 persons living with HIV have been recruited to the trial. An analysis of baseline and 6-month data is in progress. The results of this trial will not only be presented at national and international conferences but also submitted for publication in peer-reviewed journals and as a report to the funding agencies. Conclusions: This cluster randomized trial will provide critical evidence to support culturally sensitive group-based psychotherapy for depression treatment in sub-Saharan Africa. Process evaluation outcomes will provide contextual information that health care and public health stakeholders can use to guide implementation decisions for their particular setting. Trial Registration: Pan African Clinical Trials Registry (PACTR): 201608001738234; http://www.pactr.org/ATMWeb/ appmanager/atm/atmregistry?dar=true&tNo=PACTR201608001738234 (Archived by WebCite at http://www.webcitation.org/ 6vUAgAQlj)

  • Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/12/e247/; License: Creative Commons Attribution (CC-BY).

    MyVoice National Text Message Survey of Youth Aged 14 to 24 Years: Study Protocol

    Abstract:

    Background: There has been little progress in adolescent health outcomes in recent decades. Researchers and youth-serving organizations struggle to accurately elicit youth voice and translate youth perspectives into health care policy. Objective: Our aim is to describe the protocol of the MyVoice Project, a longitudinal mixed methods study designed to engage youth, particularly those not typically included in research. Text messaging surveys are collected, analyzed, and disseminated in real time to leverage youth perspectives to impact policy. Methods: Youth aged 14 to 24 years are recruited to receive weekly text message surveys on a variety of policy and health topics. The research team, including academic researchers, methodologists, and youth, develop questions through an iterative writing and piloting process. Question topics are elicited from community organizations, researchers, and policy makers to inform salient policies. A youth-centered interactive platform has been developed that automatically sends confidential weekly surveys and incentives to participants. Parental consent is not required because the survey is of minimal risk to participants. Recruitment occurs online (eg, Facebook, Instagram, university health research website) and in person at community events. Weekly surveys collect both quantitative and qualitative data. Quantitative data are analyzed using descriptive statistics. Qualitative data are quickly analyzed using natural language processing and traditional qualitative methods. Mixed methods integration and analysis supports a more in-depth understanding of the research questions. Results: We are currently recruiting and enrolling participants through in-person and online strategies. Question development, weekly data collection, data analysis, and dissemination are in progress. Conclusions: MyVoice quickly ascertains the thoughts and opinions of youth in real time using a widespread, readily available technology—text messaging. Results are disseminated to researchers, policy makers, and youth-serving organizations through a variety of methods. Policy makers and organizations also share their priority areas with the research team to develop additional question sets to inform important policy decisions. Youth-serving organizations can use results to make decisions to promote youth well-being.

  • Source: Flickr; Copyright: ThoroughlyReviewed; URL: https://www.flickr.com/photos/143842337@N03/34133641563; License: Creative Commons Attribution (CC-BY).

    Clinic Versus Online Social Network–Delivered Lifestyle Interventions: Protocol for the Get Social Noninferiority Randomized Controlled Trial

    Abstract:

    Background: Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Although online social networks have been integrated as one component of multimodality lifestyle interventions, no randomized trials to date have compared a lifestyle intervention delivered entirely via online social network with a traditional clinic-delivered intervention. Objective: This paper describes the design and methods of a noninferiority randomized controlled trial, testing (1) whether a lifestyle intervention delivered entirely through an online social network would produce weight loss that would not be appreciably worse than that induced by a traditional clinic-based lifestyle intervention among overweight and obese adults and (2) whether the former would do so at a lower cost. Methods: Adults with body mass index (BMI) between 27 and 45 kg/m2 (N=328) will be recruited from the communities in central Massachusetts. These overweight or obese adults will be randomized to two conditions: a lifestyle intervention delivered entirely via the online social network Twitter (Get Social condition) and an in-person group-based lifestyle intervention (Traditional condition) among overweight and obese adults. Measures will be obtained at baseline, 6 months, and 12 months after randomization. The primary noninferiority outcome is percentage weight loss at 12 months. Secondary noninferiority outcomes include dietary intake and moderate intensity physical activity at 12 months. Our secondary aim is to compare the conditions on cost. Exploratory outcomes include treatment retention, acceptability, and burden. Finally, we will explore predictors of weight loss in the online social network condition. Results: The final wave of data collection is expected to conclude in June 2019. Data analysis will take place in the months following and is expected to be complete in September 2019. Conclusions: Findings will extend the literature by revealing whether delivering a lifestyle intervention via an online social network is an effective alternative to the traditional modality of clinic visits, given the former might be more scalable and feasible to implement in settings that cannot support clinic-based models. Trial Registration: ClinicalTrials.gov NCT02646618; https://clinicaltrials.gov/ct2/show/NCT02646618 (Archived by WebCite at http://www.webcitation.org/6v20waTFW)

  • iPad showing the Stay Strong app. Source: Image created by the Authors; Copyright: Amelia Gulliver; URL: http://www.researchprotocols.org/2017/12/e248/; License: Creative Commons Attribution (CC-BY).

    A Peer-Led Electronic Mental Health Recovery App in an Adult Mental Health Service: Study Protocol for a Pilot Trial

    Abstract:

    Background: There is growing demand for peer workers (people who use their own lived experience to support others in their recovery) to work alongside consumers to improve outcomes and recovery. Augmenting the workforce with peer workers has strong capacity to enhance mental health and recovery outcomes and make a positive contribution to the workforce within mental health systems and to the peer workers themselves. Technology-based applications are highly engaging and desirable methods of service delivery. Objective: This project is an exploratory proof-of-concept study, which aims to determine if a peer worker-led electronic mental (e-mental) health recovery program is a feasible, acceptable, and effective adjunct to usual treatment for people with moderate to severe mental illness. Methods: The study design comprises a recovery app intervention delivered by a peer worker to individual consumers at an adult mental health service. Evaluation measures will be conducted at post-intervention. To further inform the acceptability and feasibility of the model, consumers will be invited to participate in a focus group to discuss the program. The peer worker, peer supervisor, and key staff at the mental health service will also be individually interviewed to further evaluate the feasibility of the program within the health service and further inform its future development. Results: The program will be delivered over a period of approximately 4 months, commencing June 2017. Conclusions: If the peer worker-led recovery app is found to be feasible, acceptable, and effective, it could be used to improve recovery in mental health service consumers.

  • Source: Obesity Action Coalition; Copyright: Obesity Action Coalition; URL: http://www.obesityaction.org/wp-content/uploads/ObesityAction_Lifestyle_-88.jpg; License: Fair use/fair dealings.

    The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, Methods, and Baseline Characteristics

    Abstract:

    Background: Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients). Objective: The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures—adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)—to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents. Methods: We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients’ electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure. Results: A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg/m2. RYGB was the most common bariatric procedure among adults (49.48%, 32,208/65,093), followed by SG (45.62%, 29,693/65,093) and AGB (4.90%, 3192/65,093). The mean age of the adolescent subcohort was 17 years and 77.5% (602/777) were female. Among adolescent patients with known race or ethnicity information, 67.3% (473/703) were White, 22.6% (159/703) were Black, and 18.0% (124/689) were Hispanic. The average highest recorded BMI in the year preceding surgery was 53 kg/m2. The majority of the adolescent patients received SG (60.4%, 469/777), followed by RYGB (30.8%, 239/777) and AGB (8.9%, 69/777). A BMI measurement (proxy for follow-up) was available in 84.31% (44,978/53,351), 68.09% (20,783/30,521), and 68.56% (7159/10,442) of the eligible adult patients at 1, 3, and 5 years of follow-up, respectively. The corresponding proportion was 82.0% (524/639), 49.9% (174/349), and 38.8% (47/121) in the adolescent subcohort. Conclusions: Our study cohort is one of the largest cohorts of patients with bariatric procedures in the United States. Patients are geographically and demographically diverse, which improves the generalizability of the research findings and allows examination of treatment effect heterogeneity. Ongoing and planned investigations will provide real-world evidence on the long-term benefits and risks of these most commonly used bariatric procedures in current clinical practice.

  • Source: Wikimedia Commons; Copyright: Erica Mater (US Navy); URL: https://commons.wikimedia.org/wiki/File:US_Navy_040203-N-4182M-001_National_Naval_Medical_Center_physician,_Capt._David_Thompson_performs_an_ear_tube_surgery_on_a_young_hospital_patient.jpg; License: Public Domain (CC0).

    The Second-Look Procedure for Transoral Videolaryngoscopic Surgery for T1 and T2 Laryngeal, Oropharyngeal, and Hypopharyngeal Cancer Patients: Protocol for a...

    Abstract:

    Background: Transoral videolaryngoscopic surgery (TOVS) has been widely applied for early T stage head and neck cancer. The resection is performed with a minimum safety margin for function preservation under a limited surgical field of view, making it difficult to be certain of complete resection. Objective: Our aim is the evaluation of the completeness of resection by initial TOVS resection, and the possibility of primary control by TOVS alone, allowing for repeat procedures for function preserving treatment in early T stage laryngeal, oropharyngeal, and hypopharyngeal cancer patients. Methods: Patients are treated by TOVS for the primary site with or without neck dissection. Patients are divided in two groups based on the results of the pathological evaluation of the surgical specimen; the control group in which the resection is considered to be complete, and the intervention (second-look procedure) group in which incomplete tumor resection is suspected. The predictive factors for the possibility of complete resection by TOVS will then be analyzed. Results: Patient enrollment started on January 1, 2014, and closed on March 31, 2016, with 54 patients. The control group consists of 27 patients, the intervention group is 21 patients, and 6 patients were excluded. There were no clinical differences between the control and intervention groups. The observation period will end on December 31, 2018. Conclusions: TOVS has potential for both definitive resection and function preservation with minimal invasiveness. Identifying the limitations of TOVS is beneficial to ensure accurate treatment selection in early T stage head and neck cancer patients. Trial Registration: UMIN Clinical Trials Registry: UMIN000012485; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000014472 (Archived by WebCite at http://www.webcitation.org/6v1b741Iw)

  • Source: Flickr; Copyright: Direct Relief; URL: https://www.flickr.com/photos/directrelief/4369043288/in/photostream/; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Development of an Index of Engagement in HIV Care: An Adapted Internet-Based Delphi Process

    Abstract:

    Background: Improving engagement in medical care among persons living with human immunodeficiency virus (HIV) is critical to optimizing clinical outcomes and reducing onward transmission of HIV. However, a clear conceptualization of what it means to be engaged in HIV care is lacking, and thus efforts to measure and enhance engagement in care are limited. Objective: This paper describes the use of a modified online Delphi process of consensus building to solicit input from a range of HIV and non-HIV researchers and providers, and to integrate that input with focus group data conducted with HIV-infected patients. The overarching goal was to generate items for a patient-centered measure of engagement in HIV care for use in future research and clinical practice. Methods: We recruited 66 expert panelists from around the United States. Starting with six open-ended questions, we used four rounds of online Delphi data collection in tandem with 12 in-person focus groups with patients and cognitive interviews with 25 patients. Results: We recruited 66 expert panelists from around the United States and 64 (97%) were retained for four rounds of data collection. Starting with six open-ended questions, we used four rounds of online Delphi data collection in tandem with 12 in-person focus groups with patients and cognitive interviews with 25 patients. The process resulted in an expansion to 120 topics that were subsequently reduced to 13 candidate items for the planned assessment measure. Conclusions: The process was an efficient method of soliciting input from geographically separated and busy experts across a range of disciplines and professional roles with the aim of arriving at a coherent definition of engagement in HIV care and a manageable set of survey items to assess it. Next steps are to validate the utility of the new measure in predicting retention in care, adherence to treatment, and clinical outcomes among patients living with HIV.

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  • The Effect of Manual Therapy and Stabilizing Exercises on Forward Head and Rounded Shoulder Postures: a six-week intervention with a one-month follow-up study

    Date Submitted: Dec 14, 2017

    Open Peer Review Period: Dec 16, 2017 - Dec 30, 2017

    Background: forward head and round shoulder posture is believed to alter scapular kinematics and muscle activity placing increased stress on the shoulder, leading to shoulder pain and dysfunction. Obj...

    Background: forward head and round shoulder posture is believed to alter scapular kinematics and muscle activity placing increased stress on the shoulder, leading to shoulder pain and dysfunction. Objective: The purpose of this study was to evaluate the effect of a six-week combined treatment consisting of manual therapy and stabilizing exercises, with a one-month follow-up, on neck pain with forward head and rounded shoulder postures. Methods: A total of 60 women aged 32-42 years of age with neck pain, and forward head and rounded shoulder postures were randomized into three groups: group 1 performed stabilizing exercises and received manual therapy (n=20), group 2 performed stabilizing exercises (n=20), and group 3 (control group) performed home exercises (n=20) over six weeks.The follow-up time was one month after the post test. The craniocervical and rounded shoulder angles, pain, and function were measured before and after six-week interventions, and a one-month follow- up. Results: The results showed significant positive changes within the experimental groupsin all variables, but there were minor changes in the control group in all variables before and after the intervention. Also, there were significant function and pain improvement in the experimental group 1 comparing to group 2. There were no differences between post intervention and one-month follow-up on posture and function in the experimental groups. Conclusions: These findings suggest that both interventions were significantly effective for reducing neck pain, and improving function and posture in patients with chronic neck pain, and forward head and rounded shoulder postures. However, the improvement in function and pain was more effective in group 1 than those of group 2 suggesting that manual therapy can be used as a supplement method to the stabilizing intervention in the treatment of neck pain. More research is needed to confirm the result of this study.

  • An eHealth program for patients undergoing a total hip replacement: A randomised controlled trial protocol

    Date Submitted: Dec 14, 2017

    Open Peer Review Period: Dec 15, 2017 - Dec 29, 2017

    Background: Traditionally pre and post-operative information for patients undergoing a hip replacement has been provided by paper based patient information. eHealth programs to support individualised...

    Background: Traditionally pre and post-operative information for patients undergoing a hip replacement has been provided by paper based patient information. eHealth programs to support individualised patient preoperative preparation, in-patient and home rehabilitation have potential to increase patient engagement, enhance patient recovery and reduce potential post-operative complications. Objective: The aim of this study is to compare an eHealth program versus standard care on patient outcomes for primary total hip replacement. Methods: One hundred patients undergoing a primary elective total hip replacement will be recruited from a metropolitan hospital in Western Australia to participate in a six-month parallel, non-inferiority randomized control trial. Participants randomized to the standard care group (n=50) will be given the education booklet and enrolled to attended a one-hour education session. The intervention group (n=50) will receive the same as the standard care plus access to an eHealth program titled ‘My Hip Journey’. The eHealth program encourages the patient to log in daily, from two weeks prior to surgery to thirty days’ post-surgery. The information on the platform aligns with the patient's journey including the exercises to be completed each day. The primary outcome measure is the Hip Dysfunction and Osteoarthritis Outcome Score version LK 2.0. Secondary outcome measures include the EuroQoL EQ-5D-5L, a 5-level 5-dimension quality of life measure, and the Self-Efficacy for Managing Chronic Disease Scale. Data will be collected pre-admission, and at six weeks, three months and six months’ post-surgery. A patient satisfaction survey will be completed six weeks’ post-surgery and web-based analytics will be collected at six months’ post-surgery. A cost-effectiveness analysis, using intention-to-treat, will be conducted from the hospital’s perspective. Results: N/A Conclusions: This study will compare the outcomes and cost of using an eHealth program to support a patient’s recovery from a hip replacement, with standard care. If the eHealth program is found to be effective, further implementation across clinical practice could lead to improvement in patient outcomes and other surgical areas could be incorporated. Clinical Trial: Australian New Zealand Clinical Trial Registry ACTRN12617001433392, registered on 10th October, 2017.

  • Evaluating a serious gaming electronic medication administration record (eMAR) system among nursing students: Study protocol for a pragmatic randomized controlled trial

    Date Submitted: Dec 13, 2017

    Open Peer Review Period: Dec 14, 2017 - Dec 28, 2017

    Background: While electronic medication administration record (eMAR) systems have been implemented in settings where nurses work, nursing students commonly lack robust learning opportunities to practi...

    Background: While electronic medication administration record (eMAR) systems have been implemented in settings where nurses work, nursing students commonly lack robust learning opportunities to practice the skills and workflow of digitalized medication administration during their formative education. As a result, nursing student performance administering medication facilitated by technology is often poor. Serious gaming has been recommended as a possible intervention to improve nursing students’ performance with electronic medication administration in nursing education. Objective: The objectives of this study are to examine whether the use of a gamified electronic medication administration simulator: (1) improves nursing students’ attention to medication administration safety within simulated practice; (2) increases student self-efficacy and knowledge of the medication administration process; and, (3) improves motivational and cognitive processing attributes related to student learning in a technology-enabled environment. Methods: This study is comprised of the development of a gamified electronic medication administration record simulator, and its evaluation in two phases. Phase one consists of a prospective, pragmatic randomized controlled trial with second year baccalaureate nursing students at a Canadian university. Phase two consists of qualitative focus group interviews with a cross-section of nursing student participants. Results: The gamified medication administration simulator has been developed, and data collection is currently underway. Conclusions: If the gamified electronic medication administration simulator is found to be effective, it could be used to support other health professional simulated education and scaled more widely in nursing education programs. Clinical Trial: https://clinicaltrials.gov/show/NCT03219151

  • The effects of implicit and explicit motor learning in gait rehabilitation of people after stroke: design of a randomised controlled trial

    Date Submitted: Dec 7, 2017

    Open Peer Review Period: Dec 14, 2017 - Dec 28, 2017

    Background: A significant part of neurological rehabilitation focuses on facilitating the learning of motor skills. Training can adopt either (more) explicit or (more) implicit forms of motor learning...

    Background: A significant part of neurological rehabilitation focuses on facilitating the learning of motor skills. Training can adopt either (more) explicit or (more) implicit forms of motor learning. Gait is one of the most practiced motor skills within rehabilitation in people after stroke, since it is an important criterion for discharge and requirement for functioning at home. Objective: To describe the design of a randomised controlled study assessing the effects of implicit compared to explicit motor learning in gait rehabilitation of people suffering from stroke. Methods: The study adopts a randomised, controlled, single blinded study design. People after stroke will be eligible for participation when they are in the chronic stage of recovery (>6 months after stroke), would like to improve walking performance, have a slow walking speed (<10 m/s), can communicate in Dutch, and complete a 3-stage command. People will be excluded if they cannot walk a minimum of 10 meters, or have other additional impairments that (severely) influence gait. Participants will receive nine gait training sessions over a three-week period and will be randomly allocated to an implicit or explicit group. Therapists are aware of the intervention they provide, the assessors are blind to the intervention participants receive. Outcome will be assessed, at baseline (T0), directly after the intervention (T1) and after one month (T2). The primary outcome parameter is walking velocity. Walking performance will be assessed with the 10 Meter Walking Test, Dynamic Gait Index and while performing a secondary task (dual task). Self-reported measures are the Movement Specific Reinvestment Scale, Verbal Protocol, Stroke and Aphasia Quality of Life Scale, and the Global Perceived Effect scale. A process evaluation will take place to identify how the therapy was perceived and identify factors that may have influenced the effectiveness of the intervention. Statistical analysis will be conducted to determine significant and clinical relevant differences between groups and over time. Results: Data collection is currently ongoing and results are expected in 2019. Conclusions: The relevance of the study as well as the advantages and disadvantages of several aspects of the chosen design are discussed e.g. personalised approach and choice of measurements. Clinical Trial: NTR6272

  • Comprehensive Implementation Science Study to Identify Barriers and Facilitators of 13 mHealth Projects in North America and Africa: Study Protocol for 5-year Implementation Science Study

    Date Submitted: Dec 11, 2017

    Open Peer Review Period: Dec 11, 2017 - Dec 25, 2017

    Background: Although many mHealth interventions have shown efficacy in research, few have been effectively implemented and sustained in real-world health system settings. Despite this programmatic gap...

    Background: Although many mHealth interventions have shown efficacy in research, few have been effectively implemented and sustained in real-world health system settings. Despite this programmatic gap, there is limited conclusive evidence identifying the factors that affect the implementation and successful integration of mHealth into a health system. Objective: The purpose of this study is to examine the individual, organizational and external level factors associated with the successful implementation of WelTel, mHealth intervention designed to support outpatient medication adherence and engagement in care in Africa and North America. Methods: We will adapt the Consolidated Framework for Implementation Research (CFIR) constructs for evaluation of digital healthcare implementation including a scoring and monitoring system. We will apply the adapted tool to identify facilitators and barriers to implementation of the WelTel mHealth intervention in order to determine how the technology platform is perceived, diffused, adapted and used by different mHealth project teams and health system actors in Africa and North America. We will utilize a mixed-methods approach to quantitatively test whether the factors identified in the CFIR framework are associated with the successful uptake of the mHealth intervention toward implementation goals. We will triangulate these data through interviews with project stakeholders, exploring factors associated with successful implementation and sustainment of these interventions. Results: The results of this study will provide an in-depth understanding of individual- and organizational-level factors that influence the successful implementation of mHealth in different health systems and geographic contexts over time. Via the tool’s unique scoring system connected to qualitative descriptors, these data will inform the most critical implementation targets and contribute to the tailoring of strategies that will assist the health system in overcoming barriers to implementation, and ultimately, improve treatment adherence and engagement in care. Conclusions: The results of this study will provide an in-depth understanding of individual- and organizational-level factors that influence the successful implementation of mHealth in different health systems and geographic contexts over time. Via the tool’s unique scoring system connected to qualitative descriptors, these data will inform the most critical implementation targets and contribute to the tailoring of strategies that will assist the health system in overcoming barriers to implementation, and ultimately, improve treatment adherence and engagement in care.

  • MISSION Severe Asthma: Modern Innovative Solutions to Improve Outcomes in Severe Asthma. A mixed methods observational comparison of clinical outcomes in MISSION versus current care delivery.

    Date Submitted: Dec 11, 2017

    Open Peer Review Period: Dec 11, 2017 - Dec 25, 2017

    The Specialised Services Pathway for Severe Asthma (NHS Commissioning Board, 2012/2013) recognises the burden of uncontrolled disease, ordinarily amenable to anti-inflammatory medications and the prog...

    The Specialised Services Pathway for Severe Asthma (NHS Commissioning Board, 2012/2013) recognises the burden of uncontrolled disease, ordinarily amenable to anti-inflammatory medications and the progression to longer term ‘severe’ disease necessitating high-cost therapies (e.g. Bronchial Thermoplasty). The identification and appropriate referral to a specialist asthma service is often delayed by several months or years due to poor recognition and understanding of symptom severity. Current severe asthma services may take several months to provide a comprehensive multi-disciplinary assessment often necessitating multiple hospital visits and costing up to £5000 per patient. MISSION – Modern Innovative Solutions to Improve Outcomes in Severe Asthma is a novel service model pilot developed by asthma specialists from Portsmouth and Southampton asthma services. MISSION Severe Asthma identified patients with poorly controlled disease from General Practice (GP) databases who had not been under secondary outpatient care in the last 12 months or who were not known to secondary care. In one-or two-stop assessments, a thorough review of diagnosis, disease phenotype and control is undertaken. This Protocol outlines a mixed methods study to assess the impact on disease control, unscheduled healthcare usage and quality of life in patients seen in the MISSION clinic compared to a closely matched cohort who declined to attend.

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