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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 2015: 4.532)

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:

  • Conference smartphone use. Image Source: https://www.pexels.com/photo/iphone-conference-keynote-smartphone-7115/. Copyright: startupstockphotos.com. License: CC0 License.

    Evaluation of the Swedish Web-Version of Quality of Recovery (SwQoR): Secondary Step in the Development of a Mobile Phone App to Measure Postoperative Recovery

    Abstract:

    Background: The majority of all surgeries are performed on an outpatient basis (day surgery). The Recovery Assessment by Phone Points (RAPP) app is an app for the Swedish Web-version of Quality of Recovery (SwQoR), developed to assess and follow-up on postoperative recovery after day surgery. Objectives: The objectives of this study are (1) to estimate the extent to which the paper and app versions of the SwQoR provide equivalent values; (2) to contribute evidence as to the feasibility and acceptability of a mobile phone Web-based app for measuring postoperative recovery after day surgery and enabling contact with a nurse; and (3) to contribute evidence as to the content validity of the SwQoR. Methods: Equivalence between the paper and app versions of the SwQoR was measured using a randomized crossover design, in which participants used both the paper and app version. Feasibility and acceptability was evaluated by a questionnaire containing 16 questions regarding the value of the app for follow-up care after day surgery. Content validity evaluation was based on responses by day surgery patients and the staff of the day surgery department. Results: A total of 69 participants completed the evaluation of equivalence between the paper and app versions of the SwQoR. The intraclass correlation coefficient (ICC) for the SwQoR was .89 (95% CI 0.83-0.93) and .13 to .90 for the items. Of the participants, 63 continued testing the app after discharge and completed the follow-up questionnaire. The median score was 69 (inter-quartile range, IQR 66-73), indicating a positive attitude toward using an app for follow-up after day surgery. A total of 18 patients and 12 staff members participated in the content validity evaluation. The item-level content validity index (I-CVI) for the staff group was in the 0.64 to 1.0 range, with a scale-level content validity index (S-CVI) of 0.88. For the patient group, I-CVI was in the range 0.30 to 0.92 and S-CVI was 0.67. The content validity evaluation of the SwQoR, together with three new items, led to a reduction from 34 to 24 items. Conclusions: Day surgery patients had positive attitudes toward using the app for follow-up after surgery, and stated a preference for using the app again if they were admitted for a future day surgery procedure. Equivalence between the app and paper version of the SwQoR was found, but at the item level, the ICC was less than .7 for 9 items. In the content validity evaluation of the SwQoR, staff found more items relevant than the patients, and no items found relevant by either staff or patients were excluded when revising the SwQoR.

  • CollegeDegrees360. Image source: https://www.flickr.com/photos/83633410@N07/7658298768; Copyright: Confused; License: https://creativecommons.org/licenses/by-sa/2.0/.

    Dementia and Traffic Accidents: A Danish Register-Based Cohort Study

    Abstract:

    Background: As a consequence of a rapid growth of an ageing population, more people with dementia are expected on the roads. Little is known about whether these people are at increased risk of road traffic-related accidents. Objective: Our study aims to investigate the risk of road traffic-related accidents for people aged 65 years or older with a diagnosis of dementia in Denmark. Methods: We will conduct a nationwide population-based cohort study consisting of Danish people aged 65 or older living in Denmark as of January 1, 2008. The cohort is followed for 7 years (2008-2014). Individual’s personal data are available in Danish registers and can be linked using a unique personal identification number. A person is identified with dementia if the person meets at least one of the following criteria: (1) a diagnosis of the disease in the Danish National Patient Register or in the Danish Psychiatric Central Research Register, and/or (2) at least one dementia diagnosis-related drug prescription registration in the Danish National Prescription Registry. Police-, hospital-, and emergency room-reported road traffic-related accidents occurred within the study follow-up are defined as the study outcome. Cox proportional hazard regression models are used for the main analysis. Results: Our study protocol has 3 phases including data collection, data analysis, and reporting. The first phase of register-based data collection of 853,228 individual’s personal information was completed in August, 2016. The next phase is data analysis, which is expected to be finished before December 2016, and thereafter writing publications based on the findings. The study started in January 2016 and will end in December 2018. Discussion: This study covers the entire elderly population of Denmark, and thereby will avoid selection bias due to nonparticipation and loss to follow-up. Furthermore, this ensures that the study results are reliable and generalizable. However, underreporting of traffic-related accidents may occur, which will limit estimation of absolute risks.

  • Electronic blood sugar monitor. Copyright: Biswarup Ganguly. Image source: https://simple.wikipedia.org/wiki/Diabetes_mellitus#/media/File:Blood_Glucose_Testing_-_Kolkata_2011-07-25_3982.JPG License: CC BY 3.0.

    Design and Usability Evaluation of Social Mobile Diabetes Management System in the Gulf Region

    Abstract:

    Background: The prevalence of diabetes in the Gulf States is one of the highest globally. It is estimated that 20% of the population in the region has been diagnosed with diabetes and according to the International Diabetes Federation (IDF), five of the IDF’s “top 10” countries for diabetes prevalence in 2011 and projected for 2030 are in this region. In recent years, there have been an increasing number of clinical studies advocating the use of mobile phone technology for diabetes self-management with improved clinical outcomes. However, there are few studies to date addressing the application of mobile diabetes management in the Gulf region, particularly in the Kingdom of Saudi Arabia (KSA), where there is exponential increase in mobile phone usage and access to social networking. Objective: The objective of this paper is to present the design and development of a new mobile health system for social behavioral change and management tailored for Saudi patients with diabetes called Saudi Arabia Networking for Aiding Diabetes (SANAD). A usability study for the SANAD system is presented to validate the acceptability of using mobile technologies among patients with diabetes in the KSA and the Gulf region. Methods: The SANAD system was developed using mobile phone technology with diabetes management and social networking modules. For the usability study the Questionnaire for User Interaction Satisfaction was used to evaluate the usability aspect of the SANAD system. A total of 33 users with type 2 diabetes participated in the study. Results: The key modules of the SANAD system consist of (1) a mobile diabetes management module; (2) a social networking module; and (3) a cognitive behavioral therapy module for behavioral change issues. The preliminary results of the usability study indicated general acceptance of the patients in using the system with higher usability rating in patients with type 2 diabetes. Conclusions: We found that the acceptability of the system was high among Saudi patients with diabetes, and ongoing work in this research area is underway to conduct a clinical pilot study in the KSA for patients with type 2 diabetes. The wide deployment of such a system is timely and required in the Gulf region due to the wide use of mobile phones and social networking mediums.

  • World map. Image source: https://commons.wikimedia.org/wiki/File:World_map_-_low_resolution.svg. License: Creative Commons Attribution-Share Alike 3.0 Unported.

    Reliable Quantification of the Potential for Equations Based on Spot Urine Samples to Estimate Population Salt Intake: Protocol for a Systematic Review and...

    Abstract:

    Background: Methods based on spot urine samples (a single sample at one time-point) have been identified as a possible alternative approach to 24-hour urine samples for determining mean population salt intake. Objective: The aim of this study is to identify a reliable method for estimating mean population salt intake from spot urine samples. This will be done by comparing the performance of existing equations against one other and against estimates derived from 24-hour urine samples. The effects of factors such as ethnicity, sex, age, body mass index, antihypertensive drug use, health status, and timing of spot urine collection will be explored. The capacity of spot urine samples to measure change in salt intake over time will also be determined. Finally, we aim to develop a novel equation (or equations) that performs better than existing equations to estimate mean population salt intake. Methods: A systematic review and meta-analysis of individual participant data will be conducted. A search has been conducted to identify human studies that report salt (or sodium) excretion based upon 24-hour urine samples and spot urine samples. There were no restrictions on language, study sample size, or characteristics of the study population. MEDLINE via OvidSP (1946-present), Premedline via OvidSP, EMBASE, Global Health via OvidSP (1910-present), and the Cochrane Library were searched, and two reviewers identified eligible studies. The authors of these studies will be invited to contribute data according to a standard format. Individual participant records will be compiled and a series of analyses will be completed to: (1) compare existing equations for estimating 24-hour salt intake from spot urine samples with 24-hour urine samples, and assess the degree of bias according to key demographic and clinical characteristics; (2) assess the reliability of using spot urine samples to measure population changes in salt intake overtime; and (3) develop a novel equation that performs better than existing equations to estimate mean population salt intake. Results: The search strategy identified 538 records; 100 records were obtained for review in full text and 73 have been confirmed as eligible. In addition, 68 abstracts were identified, some of which may contain data eligible for inclusion. Individual participant data will be requested from the authors of eligible studies. Conclusions: Many equations for estimating salt intake from spot urine samples have been developed and validated, although most have been studied in very specific settings. This meta-analysis of individual participant data will enable a much broader understanding of the capacity for spot urine samples to estimate population salt intake.

  • Image from GCO promotional campaign. Source and copyright: the authors.

    Get Checked… Where? The Development of a Comprehensive, Integrated Internet-Based Testing Program for Sexually Transmitted and Blood-Borne Infections in...

    Abstract:

    Background: Testing for sexually transmitted and blood-borne infections (STBBI) is an effective public health strategy that can promote personal control of one’s health and prevent the spread of these infections. Multiple barriers deter access to testing including fear of stigmatization, inaccurate health care provider perceptions of risk, and reduced availability of clinic services and infrastructure. Concurrent increases in sexually transmitted infection (STI) rates and demands on existing clinical services make this an even more pressing concern. Web-based testing offers several advantages that may alleviate existing clinical pressures and facilitate appropriate testing access. Objective: This paper describes the planning, development, and usability testing of a novel Web-based testing service, GetCheckedOnline (GCO), as a complementary testing option integrated within existing sexual health services within British Columbia (BC). Methods: From 2009 to 2014, we engaged a multidisciplinary team in the design and development of GCO. We conducted 3 initial research studies to ascertain the opinions of youth, men who have sex with men (MSM), and STI clinic clients regarding Web-based testing and elicited perspectives of sexual health care providers through focus groups. We developed an informed consent process, risk assessment questions, and test recommendations based on provincial and national guidelines and evaluated these through consultations with clinical and community stakeholders. We also conducted a preliminary health equity impact assessment whose findings also informed the GCO program mode. Finally, from April 2011 to December 2012 we gathered qualitative data from 25 participants on the functionality and usability of a GCO prototype and incorporated their recommendations into a final model. Results: GCO launched in the fall of 2014 across 6 pilot sites in Vancouver, BC. The service involves 3 main steps: (1) create an account, complete an assessment, and print a laboratory requisition, (2) provide blood and urine specimens at participating laboratory locations, and (3) receive test results on the Internet or by phone. During this pilot phase, we promoted GCO to existing STI clinic clients and MSM in the Greater Vancouver region. A rigorous mixed-method evaluation of GCO’s uptake, acceptability, and health system impacts is currently underway. Conclusions: GCO is the first comprehensive Web-based STBBI testing program in Canada that is integrated with existing sexual health services, with the potential to reduce pressures on existing clinical services and reach populations facing the greatest barriers to testing. Our experience highlights the facilitators and challenges of developing and implementing novel complex eHealth interventions within the health care system, and underscores the importance of considering broader implementation contexts.

  • Image source: Patient's hand explaining for doctor, used under license from takasu/Shutterstock.com,  http://www.shutterstock.com/pic-250522258.

    A Cluster-Randomized Controlled Trial Evaluating the Effectiveness and Cost-Effectiveness of Tobacco Cessation on Prescription in Swedish Primary Health...

    Abstract:

    Background: In Sweden, the prevalence of tobacco use is disproportionately high among socioeconomically disadvantaged groups. Previous research and clinical experience suggest that prescribed lifestyle interventions in the primary health care (PHC) setting such as Physical Activity on Prescription are effective in changing behavior. However, there is a lack of evidence for if and how such a prescription approach could be effectively transferred into the tobacco cessation context. Objective: The aim of this trial is to evaluate the effectiveness and cost-effectiveness of Tobacco Cessation on Prescription (TCP) compared to current practice for tobacco cessation targeting socioeconomically disadvantaged groups in the PHC setting in Sweden. Methods: The design is a pragmatic cluster-randomized controlled trial. The sample will consist of 928 daily tobacco users with Swedish social security numbers and permanent resident permits, recruited from 14-20 PHC centers located in socioeconomically disadvantaged areas in Stockholm County. The primary outcome will be measured in self-reported 7-day abstinence at 6 and 12 months after the intervention. The secondary outcomes will be measured in daily tobacco consumption, number of quit attempts, and health-related quality of life at 6 and 12 months after the intervention. Data will be collected through questionnaires and review of electronic medical records. Cost-effectiveness will be estimated through decision analytic modeling and measured by the incremental cost per quality-adjusted life year. Results: In the first set of PHC centers participating in the study, eight centers have been included. Recruitment of individual study participants is currently ongoing. Inclusion of a second set of PHC centers is ongoing with expected study start in September 2016. Conclusions: If TCP is found effective and cost-effective compared to standard treatment, the method could be implemented to facilitate tobacco cessation for socioeconomically disadvantaged groups in the PHC setting in Sweden. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 11498135; http://www.isrctn.com/ISRCTN11498135 (Archived by WebCite at http://www.webcitation.org/6kTu6giYQ)

  • A registered Nutritionist measures the height of an older adult, for the Nutrition UP 65 study. Image sourced and copyright held by authors.

    Nutritional Strategies Facing an Older Demographic: The Nutrition UP 65 Study Protocol

    Abstract:

    Background: The population of Portugal is aging. The lack of data on older adults’ nutritional status and the lack of nutrition knowledge amongst health professionals, caregivers, and older adults themselves, remains a challenge. Objective: The Nutrition UP 65 study aims to reduce nutritional inequalities in the older Portuguese adult population and improve knowledge regarding older Portuguese adults’ nutritional status, specifically relating to undernutrition, obesity, sarcopenia, frailty, hydration, sodium, and vitamin D statuses. Methods: A representative sample of older Portuguese adults was selected. Sociodemographic, lifestyle, anthropometric, functional, and clinical data were collected. Sodium excretion, hydration, and vitamin D statuses were assessed. Results: Data collection (n=1500) took place between December, 2015 and June, 2016. Results will be disseminated in national and international scientific journals, and via Portuguese media. Conclusions: Nutrition UP 65 results will provide evidence for the design and implementation of effective preventive public health strategies regarding the elderly. These insights may represent relevant health gains and costs savings.

  • Highlighted male colon. Copyright: Sebastian Kaulitzki, Dreamstime. Image purchased by Authors Louise Rasmussen et al. 
ULR: http://www.dreamstime.com/stock-images-highlighted-male-colon-image28961904.

    Protocol Outlines for Parts 1 and 2 of the Prospective Endoscopy III Study for the Early Detection of Colorectal Cancer: Validation of a Concept Based on...

    Abstract:

    Background: Programs for population screening of colorectal cancer (CRC) have been implemented in several countries with fecal immunochemical testing (FIT) as the preferred platform. However, the major obstacle for a feces-based testing method is the limited compliance that reduces the clinical sensitivity for detection of participants with non-symptomatic CRC. Therefore, research approaches have been initiated to develop screening concepts based on biomarkers in blood. Preliminary results show that protein, genetic, epigenetic, and metabolomic components may be valuable in blood-based screening concepts, particularly when combinations of the various components appear to lead to significant improvements. Objectives: The protocol described in this paper focuses on the validation of concepts based on biomarkers in blood in a major population screened by FIT. Methods: In Part 1, participants will be identified and included through the Danish CRC Screening Program comprising initial FIT and subsequent colonoscopy to those with a positive result. Blood samples will be collected from 8000 FIT-positive participants, who are offered subsequent colonoscopy. Findings and interventions at colonoscopy together with personal data including co-morbidity will be recorded. Blood samples and data will also be collected from 6000 arbitrarily chosen participants with negative FIT. In Part 2, blood samples and data will be collected from 30,000 FIT-negative participants three times within 4 years. The blood samples will be analyzed using various in-house and commercially available manual and automated analysis platforms. Results: We anticipate Part 1 to terminate late August 2016 and Part 2 to terminate late September 2022. The results from Parts 1 and 2 will be presented within 12 to 18 months from termination. Conclusions: The purpose of this study is to improve the efficacy of identifying participants with neoplastic bowel lesions, to identify false negative participants, to identify participants at risk of interval neoplastic lesions, to improve the compliance in screening sessions, and to establish guidelines for out-patient follow-up of at-risk participants based on combinations of blood-based biomarkers.

  • Running. Image sourced and copyright owned by authors Tobias Kowatsch et al.

    Effects of Charitable Versus Monetary Incentives on the Acceptance of and Adherence to a Pedometer-Based Health Intervention: Study Protocol and Baseline...

    Abstract:

    Background: Research has so far benefited from the use of pedometers in physical activity interventions. However, when public health institutions (eg, insurance companies) implement pedometer-based interventions in practice, people may refrain from participating due to privacy concerns. This might greatly limit the applicability of such interventions. Financial incentives have been successfully used to influence both health behavior and privacy concerns, and may thus have a beneficial effect on the acceptance of pedometer-based interventions. Objective: This paper presents the design and baseline characteristics of a cluster-randomized controlled trial that seeks to examine the effect of financial incentives on the acceptance of and adherence to a pedometer-based physical activity intervention offered by a health insurance company. Methods: More than 18,000 customers of a large Swiss health insurance company were allocated to a financial incentive, a charitable incentive, or a control group and invited to participate in a health prevention program. Participants used a pedometer to track their daily physical activity over the course of 6 months. A Web-based questionnaire was administered at the beginning and at the end of the intervention and additional data was provided by the insurance company. The primary outcome of the study will be the participation rate, secondary outcomes will be adherence to the prevention program, physical activity, and health status of the participants among others. Results: Baseline characteristics indicate that residence of participants, baseline physical activity, and subjective health should be used as covariates in the statistical analysis of the secondary outcomes of the study. Conclusions: This is the first study in western cultures testing the effectiveness of financial incentives with regard to a pedometer-based health intervention offered by a large health insurer to their customers. Given that the incentives prove to be effective, this study provides the basis for powerful health prevention programs of public health institutions that are easy to implement and can reach large numbers of people in need.

  • Patient checking through website provided feedback of clinical outcome of cholesterol. Image sourced and copyright owned by authors Angelien Sieben et al.

    A Multifaceted Nurse- and Web-Based Intervention for Improving Adherence to Treatment in Patients With Cardiovascular Disease: Rationale and Design of the...

    Abstract:

    Background: Poor adherence to medication is one of the limitations in the treatment of cardiovascular diseases, thereby increasing the risk of premature death, hospital admissions, and related costs. There is a need for simple and easy-to-implement interventions that are based on patients’ perspectives, beliefs, and perceptions of their illness and medication. Objective: The objective is to test the effectivity of this intervention to improve medication adherence in patients with established cardiovascular disease, that is, in secondary prevention. Methods: In this study the effect of a personalized visualization of cardiovascular risk levels through a website aiming at supporting self management in combination with a group consultation and communication intervention by a nurse on adherence to treatment in 600 patients with manifest cardiovascular diseases will be assessed. The health belief model was chosen as main theoretical model for the intervention. Results: Primary outcome is adherence to treatment calculated by refill data. Secondary outcomes include the Beliefs about Medication Questionnaire and the Modified Morisky Scale. Patients are followed for one year. Results are expected by 2015. Conclusions: This study assesses adherence to treatment in a high-risk cardiovascular population by applying an intervention that addresses patients’ capacity and practical barriers as well as patients’ beliefs and perceptions of their illness and medication. ClinicalTrial: ClinicalTrials.gov NCT01449695; https://clinicaltrials.gov/ct2/show/NCT01449695 (Archived by WebCite at http://www.webcitation.org/6kCzkIKH3)

  • Holding hands. Image source: www.awrj.nl. Copyright owned and permission to use granted by ©AWFZJ.

    Family-Centered Care in Juvenile Justice Institutions: A Mixed Methods Study Protocol

    Abstract:

    Background: Treatment and rehabilitation interventions in juvenile justice institutions aim to prevent criminal reoffending by adolescents and to enhance their prospects of successful social reintegration. There is evidence that these goals are best achieved when the institution adopts a family-centered approach, involving the parents of the adolescents. The Academic Workplace Forensic Care for Youth has developed two programs for family-centered care for youth detained in groups for short-term and long-term stay, respectively. Objective: The overall aim of our study is to evaluate the family-centered care program in the first two years after the first steps of its implementation in short-term stay groups of two juvenile justice institutions in the Netherlands. The current paper discusses our study design. Methods: Based on a quantitative pilot study, we opted for a study with an explanatory sequential mixed methods design. This pilot is considered the first stage of our study. The second stage of our study includes concurrent quantitative and qualitative approaches. The quantitative part of our study is a pre-post quasi-experimental comparison of family-centered care with usual care in short-term stay groups. The qualitative part of our study involves in-depth interviews with adolescents, parents, and group workers to elaborate on the preceding quantitative pilot study and to help interpret the outcomes of the quasi-experimental quantitative part of the study. Results: We believe that our study will result in the following findings. In the quantitative comparison of usual care with family-centered care, we assume that in the latter group, parents will be more involved with their child and with the institution, and that parents and adolescents will be more motivated to take part in therapy. In addition, we expect family-centered care to improve family interactions, to decrease parenting stress, and to reduce problem behavior among the adolescents. Finally, we assume that adolescents, parents, and the staff of the institutions will be more satisfied with family-centered care than with usual care. In the qualitative part of our study, we will identify the needs and expectations in family-centered care as well as factors influencing parental participation. Insight in these factors will help to further improve our program of family-centered care and its implementation in practice. Our study results will be published over the coming years. Conclusions: A juvenile justice institution is a difficult setting to evaluate care programs. A combination of practice-based research methods is needed to address all major implementation issues. The study described here takes on the challenge by means of practice-based research. We expect the results of our study to contribute to the improvement of care for adolescents detained in juvenile justice institutions, and for their families.

  • Doppler. Image sourced and copyright owned by Authors Angela E Rankine-Mullings et al.

    EXpanding Treatment for Existing Neurological Disease (EXTEND): An Open-Label Phase II Clinical Trial of Hydroxyurea Treatment in Sickle Cell Anemia

    Abstract:

    Background: Cerebral vasculopathy in sickle cell anemia (SCA) begins in childhood and features intracranial arterial stenosis with high risk of ischemic stroke. Stroke risk can be reduced by transcranial doppler (TCD) screening and chronic transfusion therapy; however, this approach is impractical in many developing countries. Accumulating evidence supports the use of hydroxyurea for the prevention and treatment of cerebrovascular disease in children with SCA. Recently we reported that hydroxyurea significantly reduced the conversion from conditional TCD velocities to abnormal velocities; whether hydroxyurea can be used for children with newly diagnosed severe cerebrovascular disease in place of starting transfusion therapy remains unknown. Objective: The primary objective of the EXpanding Treatment for Existing Neurological Disease (EXTEND) trial is to investigate the effect of open label hydroxyurea on the maximum time-averaged mean velocity (TAMV) after 18 months of treatment compared to the pre-treatment value. Secondary objectives include the effects of hydroxyurea on serial TCD velocities, the incidence of neurological and non-neurological events, quality of life (QOL), body composition and metabolism, toxicity and treatment response, changes to brain magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA), genetic and serologic markers of disease severity, and cognitive and pulmonary function. Methods: This prospective Phase II trial will enroll children with SCA in Jamaica, between the ages of 2 and 17 years, with either conditional (170-199 cm/sec) or abnormal (≥ 200 cm/sec) TCD velocities. Oral hydroxyurea will be administered daily and escalated to the maximum tolerated dose (MTD). Participants will be seen in the Sickle Cell Unit (SCU) in Kingston, Jamaica monthly until achieving MTD, and then every 3 months. TCD will be performed every 6 months. Results: Currently, 43 participants have been enrolled out of a projected 50. There was one withdrawal due to immigration, with no permanent screen failures. Of the 43 enrolled, 37 participants have initiated study treatment. Conclusions: This trial investigates the effects of hydroxyurea treatment at MTD in children with conditional or abnormal TCD velocities before transfusion therapy and may represent an important advance towards establishing a suitable non-transfusion protocol for stroke prevention in children with SCA. The trial outcomes will have profound significance in developing countries where the disease burden is highest. Clinical Trial: ClinicalTrials.gov NCT02556099; https://clinicaltrials.gov/ct2/show/NCT02556099 (Archived by WebCite at http://www.webcitation.org/6k1yMAa9G)

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  • A Mobile and Web-Based Clinical Decision Support and Monitoring System for Diabetes Mellitus Patients in Primary Care: A Study Protocol for a Randomized Controlled Trial

    Date Submitted: Sep 29, 2016

    Open Peer Review Period: Sep 30, 2016 - Oct 14, 2016

    Background: Physicians’ utilization rates of diagnosis, treatment and monitoring guidelines for diabetes mellitus (DM) is very low. Because of time constraints, overpopulation of patients and comple...

    Background: Physicians’ utilization rates of diagnosis, treatment and monitoring guidelines for diabetes mellitus (DM) is very low. Because of time constraints, overpopulation of patients and complexity of guidelines, alternative solutions are required. Rapidly evolving e-health technology will be a solution to such problems in terms of clinical decision support and monitoring systems (CDSMS). Objective: The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based CDSMS for DM diseases screening, diagnosis, treatment and monitoring for the use of physicians and patients in primary care and to determine the effectiveness of the system. Methods: Methods: CDSMS will be based on evidence-based guidelines for DM diseases. Web and mobile-based application will be developed. The remote monitoring of patient data collected through mobile applications will be provided. The system will be physician –assisted. A database containing patient data will be created. The developed CDSMS will be tested in two stages. In the first stage, the usability, understandability and adequacy of the application will be determined. 5 family physicians will use the developed application for at least their 16 DM patients. Then, necessary adjustments in the application will be made in accordance with the feedback of the interviews with physicians and patients. In the second phase, the system will be validated. A parallel single blind randomized controlled trial will be implemented. 10 physicians and their 439 patients are involved in the study. According to the results of screening which is done using developed CDSMS, DM diagnosed patients will be recruited for trial from the primary care centers by the physicians. The recruited patients will register to the CDSMS with their accounts given by their physicians. Eligible participants will be assigned to intervention and control groups with simple randomization. The significance level will be accepted as p<0,05. In the intervention group, the system recommendations on diagnosis, treatment and monitoring will be carried out as the final decision given by the physician. In the control group, physicians will treat DM patients as the general routine. Patients in both groups will be monitored for 6 months. Patient data on 0th and 6th month will be compared. Clinical and laboratory outcomes will be face-to-face assessed, others will be online self-assessed. Results: Primary outcomes include HbA1c, Fasting Blood Glucose and Postprandial Blood Glucose levels. Secondary outcomes include body mass index, diabetes-related emotional burden and interpersonal distress sub-scales, self-efficacy for diabetes self-care: blood glucose monitoring, physical activity, nutrition, medication-taking, diabetes self-care: blood glucose self-monitoring, medication-taking, smoking and alcohol using and physical activity, depression, anxiety, stress levels. This study is a part of a project which currently underway with funding support from The Scientific and Technological Research Council of Turkey. Study results are expected to be published in the middle of 2018. Conclusions: Among the fields of medical expertise providing health services to DM patients, the developed system using evidence-based guidelines will be the first example.

  • Epidemiology of patient harms in New Zealand general practices: Records review study

    Date Submitted: Sep 25, 2016

    Open Peer Review Period: Sep 26, 2016 - Oct 10, 2016

    Knowing where and why harm occurs in general practice will assist patients, doctors and others make informed decisions about the risks and benefits of treatment options. Research to date has been un...

    Knowing where and why harm occurs in general practice will assist patients, doctors and others make informed decisions about the risks and benefits of treatment options. Research to date has been unable to verify the safety of primary health care and epidemiological research about patient harms in general practice is now a top priority for advancing health systems safety. We therefore aim to study the incidence, distribution, severity, and preventability of the harms patients experience due to their healthcare, from the whole-of-health-system lens afforded by electronic general practice patient records. ‘Harm’ is defined as disease, injury, disability, suffering and death, arising from the health system. The study design is a stratified, two-level cluster, retrospective records review study. Both general practices and patients will be randomly selected so that the study’s results will apply nationally, after weighting. Stratification by practice size and rurality will allow comparisons between six study groups (large, medium-sized, small; urban, and rural practices). Records of equal numbers of patients from each study group will be included in the study because there may be systematic differences in patient harms in different types of practices. Eight general practitioner investigators will review three years of electronic general practice health records (consultation notes, prescriptions, investigations, referrals, and summaries of hospital care) from 9000 patients registered in 60 general practices. Double reviews will check the concordance of reviewers’ assessments. Study data will comprise demographic data of all 9000 patients and reviewers’ assessments of whether patients experienced harm arising from healthcare. Where patient harm is identified, their types, preventability, severity, and outcomes will be coded using MedDRA 18.0 and measured. The design of this complex study is presented with discussion on data collection methods, sampling weightings, power analysis and statistical approach. Lessons from a feasibility study are reported.

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    Date Submitted: Sep 23, 2016

    Open Peer Review Period: Sep 24, 2016 - Oct 8, 2016

    There are an estimated three million people in the UK with COPD and the incidence of Bronchiectasis is estimated at around 0.1% but is more common in COPD and severe asthma. Both COPD and Bronchiectas...

    There are an estimated three million people in the UK with COPD and the incidence of Bronchiectasis is estimated at around 0.1% but is more common in COPD and severe asthma. Both COPD and Bronchiectasis are characterised by exacerbations in which bacteria play a central role. Pseudomonas aeruginosa (PA) is isolated from sputum samples from 4–15% of adults with COPD and is more likely to be isolated from patients with severe disease. Earlier detection of exacerbations may improve morbidity and mortality by expediting treatment. Aseptika Ltd (Cambridgeshire, UK) has developed a system for patients to self-monitor important physiological measurements including levels of physical activity, peak flow, FEV1 and biomarkers for PA in sputum. We aim to test this system in twenty participants with PA colonisation, and ten controls with Haemophilus influenzae(HI). We plan to recruit 30 adult participants with COPD or non-CF Bronchiectasis who have previously cultured PA or HI during an exacerbation in the last six months. They must produce sputum on most days and should have been stable for four weeks prior to entry. Daily data collected will include symptoms, healthcare usage, medication, weight, FEV1, physical activity level, blood pressure, oxygen saturation and temperature. Sputum and urine samples will be provided daily. These data will be analysed to assess predictive value in detecting upcoming exacerbations. Qualitative data will be gathered through self-administered questionnaires and semi-structured interviews to gather information on participants coping and their use of the technology involved.

  • Automated Adherence Reminders for High Risk Children with Asthma: Research Protocol

    Date Submitted: Sep 23, 2016

    Open Peer Review Period: Sep 23, 2016 - Oct 7, 2016

    Background: The use of inhaled corticosteroid (ICS) medications has been shown to improve asthma control and reduce asthma-related morbidity and mortality. Two recent randomized trials demonstrated d...

    Background: The use of inhaled corticosteroid (ICS) medications has been shown to improve asthma control and reduce asthma-related morbidity and mortality. Two recent randomized trials demonstrated dramatic improvements in ICS adherence by monitoring adherence with electronic sensors and providing automated reminders to participants to take their ICS medications. Given their lower levels of adherence and higher levels of asthma-related emergency department (ED) visits, hospitalizations, and death, urban minority populations could potentially benefit greatly from these types of interventions. Objective: The principle objective of this study will be to evaluate the feasibility, acceptability, and limited efficacy of a text message reminder intervention to enhance ICS adherence in an urban minority population of children with asthma. We will also assess trajectories of ICS adherence in the two months following asthma hospitalization. Methods: Participants will include children ages 2-13 who are currently admitted to the Children’s Hospital of Philadelphia (CHOP) for asthma and their parent or legal guardian. Participants will be assigned to intervention and control arms using a 1:1 randomization scheme. The intervention arm will receive daily text message reminders for a 30-day intervention phase following hospitalization. This will be followed by a 30-day follow-up phase, in which all participants may choose whether or not to receive the text messages. Feasibility will be assessed by measuring (1) retention of the participants through the study phases and (2) perceived usefulness, acceptability, and preferences regarding the intervention components. Limited efficacy outcomes will include percent adherence to prescribed ICS regimen and change in parent-reported asthma control. We will perform an exploratory analysis to assess for discrete trajectories of adherence using group-based trajectory modeling (GBTM). Results: Study enrollment began in December 2015 and the intervention and follow-up phases are ongoing. Results of the data analysis are expected to be available by December 2016. Conclusions: This study will add to the literature by providing foundational feasibility data on which elements of a mobile health text-message reminder intervention may need to be modified to suit the needs and constraints of high-risk urban minority populations. Clinical Trial: Clinicaltrials.gov: NCT02615743; https://www.clinicaltrials.gov/ct2/show/study/NCT02615743?view=results; archived with WebCite® at http://www.webcitation.org/6ji59rAXN

  • Cognitive and Psychosocial Assessment After Mechanical Ventilation in Intensive Care - Does an Experience of Delirium Make a Difference: The CAPA Study Protocol

    Date Submitted: Sep 17, 2016

    Open Peer Review Period: Sep 19, 2016 - Oct 3, 2016

    Background: In the Intensive Care Unit (ICU) critical illness delirium occurs in the context of multiple co-morbidities, multi-organ failure, and invasive management techniques, such as mechanical ven...

    Background: In the Intensive Care Unit (ICU) critical illness delirium occurs in the context of multiple co-morbidities, multi-organ failure, and invasive management techniques, such as mechanical ventilation, sedation and lack of sleep. Delirium is characterized by an acute confusional state defined by fluctuating mental status, inattention and, either disorganised thinking or an altered level of consciousness. The impact of delirium in ICU on the long-term cognitive and psychosocial function of patients who experience it is of crucial interest. Preliminary data suggest strong association between ICU delirium and long-term cognitive impairment. Objective: We aim to explore the relationship of delirium in ICU to adverse outcomes. We are doing so by following mechanically ventilated patients for a yearafter their ICU discharge. We aim to collect data on their long-term cognition andpsychosocial function. Methods: We are conducting this study by enrolling patients in two tertiary Intensive Care Units in Australia. We aim to recruit 200 patients who have been mechanically ventilated for more than 24 hours. Data is collected at three time points following discharge from ICU: at discharge patients are administered the Mini Mental State Examination (MMSE); at 6 months after ICU discharge they are administered the Impact of Events Scale Revised (IES-R) and the Telephone Inventory for Cognitive Status (TICS); and again at 12 months after ICU discharge patients are administered the TICS and IES-R, as well as the Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE), which is administered Results: We aim to assess long-term cognition and psychosocial function as our primary outcomes. We will investigate mortality as a secondary outcome. The study is enrolling until end of September 2016 and data collection will conclude at the end of September 2017. The analysis and results are expected to be available by March 2018 Conclusions: We aim to assess long-term cognition and psychosocial function as our primary outcomes. We will investigate mortality as a secondary outcome. The study is enrolling until end of September 2016 and data collection will conclude at the end of September 2017. The analysis and results are expected to be available by March 2018. Conclusion: Delirium during mechanical ventilation has been linked with longer ICU and hospital stay and associated financial burden; a higher risk of long-term cognitive impairment, including dementia; poor functional outcomes and quality of life; and decreased survival. Delirium during mechanical ventilation in ICU is not well understood, and this study will advance knowledge of the comprehensive long-term effects on cognitive and psychosocial function. Clinical Trial: Trial Registration: ACTRN12616001116415

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