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1.	Alriksson-Schmidt, Ann I., et al. (författare) The natural history of spina bifida in children pilot project : Research protocol 2013 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 2:1 Tidskriftsartikel (refereegranskat)abstract Background: Population-based empirical information to inform health care professionals working with children with spina bifida currently is lacking. Spina bifida is a highly complex condition that not only affects mobility but many additional aspects of life. We have developed a pilot project that focuses on a broad range of domains: Surgeries, development and learning, nutrition and physical growth, mobility and functioning, general health, and family demographics. Specifically, we will: (1) explore the feasibility of identifying and recruiting participants using different recruitment sources, (2) test a multidisciplinary module to collect the data, (3) determine the utility of different methods of retrieving the data, and (4) summarize descriptive information on living with spina bifida. Objective: The overall objective of the project was to provide information for a future multistate prospective study on the natural history of spina bifida. Methods: Families with a child 3 to 6 years of age with a diagnosis of spina bifida were eligible for enrollment. Eligible families were identified through a US population-based tracking system for birth defects and from a local spina bifida clinic. Results: This is an ongoing project with first results expected in 2013. Conclusions: This project, and the planned multistate follow-up project, will provide information both to health care professionals experienced in providing care to patients with spina bifida, and to those who have yet to work with this population. The long-term purpose of this project is to increase the knowledge about growing up with spina bifida and to guide health care practices by prospectively studying a cohort of children born with this condition.
2.	Alriksson-Schmidt, Ann, et al. (författare) Improving the Health of Individuals With Cerebral Palsy: Protocol for the Multidisciplinary Research Program MOVING ON WITH CP 2019 Ingår i: Jmir Research Protocols. - Toronto, Canada : JMIR Publications Inc.. - 1929-0748. ; 8:10 Tidskriftsartikel (refereegranskat)abstract Background: Cerebral palsy (CP) is one of the most common early onset disabilities globally. The causative brain damage in CP is nonprogressive, yet secondary conditions develop and worsen over time. Individuals with CP in Sweden and most of the Nordic countries are systematically followed in the national registry and follow-up program entitled the Cerebral Palsy Follow-Up Program (CPUP). CPUP has improved certain aspects of health care for individuals with CP and strengthened collaboration among professionals. However, there are still issues to resolve regarding health care for this specific population. Objective: The overall objectives of the research program MOVING ON WITH CP are to (1) improve the health care processes and delivery models; (2) develop, implement, and evaluate real-life solutions for Swedish health care provision; and (3) evaluate existing health care and social insurance benefit programs and processes in the context of CP. Methods: MOVING ON WITH CP comprises 9 projects within 3 themes. Evaluation of Existing Health Care (Theme A) consists of registry studies where data from CPUP will be merged with national official health databases, complemented by survey and interview data. In Equality in Health Care and Social Insurance (Theme B), mixed methods studies and registry studies will be complemented with focus group interviews to inform the development of new processes to apply for benefits. In New Solutions and Processes in Health Care Provision (Theme C), an eHealth (electronic health) procedure will be developed and tested to facilitate access to specialized health care, and equipment that improves the assessment of movement activity in individuals with CP will be developed. Results: The individual projects are currently being planned and will begin shortly. Feedback from users has been integrated. Ethics board approvals have been obtained. Conclusions: In this 6-year multidisciplinary program, professionals from the fields of medicine, social sciences, health sciences, and engineering, in collaboration with individuals with CP and their families, will evaluate existing health care, create conditions for a more equal health care, and develop new technologies to improve the health care management of people with CP.
3.	Anderberg, Peter, et al. (författare) Analyzing nursing students’ relation to electronic health and technology as individuals and students and in their future career (the ENURSED study) : Protocol for a longitudinal study 2019 Ingår i: Journal of Medical Internet Research. - : Journal of Medical Internet Research. - 1438-8871. ; 21:10 Tidskriftsartikel (refereegranskat)abstract Background: The nursing profession has undergone several changes in the past decades, and new challenges are to come in the future; patients are now cared for in their home, hospitals are more specialized, and primary care will have a key role. Health informatics is essential in all core competencies in nursing. From an educational perspective, it is of great importance that students are prepared for the new demands and needs of the patients. From a societal point of view, the society, health care included, is facing several challenges related to technological developments and digitization. Preparation for the next decade of nursing education and practice must be done, without the advantage of certainty. A training for not-yet-existing technologies where educators should not be limited by present practice paradigms is desirable. This study presents the design, method, and protocol for a study that investigates undergraduate nursing students’ internet use, knowledge about electronic health (eHealth), and attitudes to technology and how experiences of eHealth are handled during the education in a multicenter study. Objective: The primary aim of this research project is to describe the design of a longitudinal study and a qualitative substudy consisting of the following aspects that explore students’ knowledge about and relation to technology and eHealth: (1) what pre-existing knowledge and interest of this area the nursing students have and (2) how (and if) is it present in their education, (3) how do the students perceive this knowledge in their future career role, and (4) to what extent is the education capable of managing this knowledge? Methods: The study consists of two parts: a longitudinal study and a qualitative substudy. Students from the BSc in Nursing program from the Blekinge Institute of Technology, Karlskrona, Sweden, and from the Swedish Red Cross University College, Stockholm/Huddinge, Sweden, were included in this study. Results: The study is ongoing. Data analysis is currently underway, and the first results are expected to be published in 2019. Conclusions: This study presents the design of a longitudinal study and a qualitative substudy. The eHealth in Nursing Education eNursEd study will answer several important questions about nursing students’ attitudes toward and use of information and communications technology in their private life, their education, and their emerging profession. Knowledge from this study will be used to compare different nursing programs and students’ knowledge about and relation to technology and eHealth. Results will also be communicated back to nursing educators to improve the teaching of eHealth, health informatics, and technology. ©Peter Anderberg, Gunilla Björling, Louise Stjernberg, Doris Bohman.
4.	Anderberg, Peter, et al. (författare) The Effects of the Digital Platform Support Monitoring and Reminder Technology for Mild Dementia (SMART4MD) for People With Mild Cognitive Impairment and Their Informal Carers : Protocol for a Pilot Randomized Controlled Trial 2019 Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 8:6 Tidskriftsartikel (refereegranskat)abstract Background: Many countries are witnessing a trend of growth in the number and proportion of older adults within the total population. In Europe, population aging has had and will continue to have major social and economic consequences. This is a fundamentally positive development where the added life span is of great benefit for both the individual and the society. Yet, the risk for the individual to contract noncommunicable diseases and disability increases with age. This may adversely affect the individual's ability to live his or her life in the way that is desired. Cognitive conditions constitute a group of chronic diseases that predominantly affects older people. Recent technology advancements can help support the day-to-day living activities at home for people with cognitive impairments. Objective: A digital platform (Support Monitoring and Reminder for Mild Dementia; SMART4MD) is created to improve or maintain the quality of life for people with mild cognitive impairment (PwMCI) and their carers. The platform will provide reminders, information, and memory support in everyday life, with the purpose of giving structure and lowering stress. In the trial, we will include participants with a diagnosed neurocognitive disorder as well as persons with an undiagnosed subjective memory problem and cognitive impairment, that is, 20 to 28 points on the Mini-Mental State Examination. Methods: A pragmatic, multicenter RCT is being conducted in Spain, Sweden, and Belgium. The targets for recruitment are 1200 dyads-split into an intervention group and a control group that are in usual care. Intervention group participants will be provided with a data-enabled computer tablet with the SMART4MD app. Its core functionalities, intended to be used daily at home, are based on reminders, cognitive supporting activities, and sharing health information. Results: Inclusion of participants started in December 2017, and recruitment is expected to end in February 2019. Furthermore, there will be 3 follow-up visits at 6, 12, and 18 months after the baseline visit. Conclusions: This RCT is expected to offer benefits at several levels including in-depth knowledge of the possibilities of introducing a holistic multilayered information and communication technology solution for this group. SMART4MD has been developed in a process involving the structured participation of PwMCI, their informal carers, and clinicians. The adoption of SMART4MD faces the challenge of this age group's relative unfamiliarity with digital devices and services. However, this challenge can also be an opportunity for developing a digital device tailored to a group at risk of digital exclusion. This research responds to the wider call for the development of digital devices which are accessible and affordable to older people and this full scale RCT can hopefully serve as a model for further studies in this field.
5.	Bachnick, Stefanie, et al. (författare) TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) Project : Protocol for an International Longitudinal Multicenter Study 2024 Ingår i: JMIR Research Protocols. - 1929-0748. ; 13 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: Nursing-sensitive events (NSEs) are common, accounting for up to 77% of adverse events in hospitalized patients (eg, fall-related harm, pressure ulcers, and health care-associated infections). NSEs lead to adverse patient outcomes and impose an economic burden on hospitals due to increased medical costs through a prolonged hospital stay and additional medical procedures. To reduce NSEs and ensure high-quality nursing care, appropriate nurse staffing levels are needed. Although the link between nurse staffing and NSEs has been described in many studies, appropriate nurse staffing levels are lacking. Existing studies describe constant staffing exposure at the unit or hospital level without assessing patient-level exposure to nurse staffing during the hospital stay. Few studies have assessed nurse staffing and patient outcomes using a single-center longitudinal design, with limited generalizability. There is a need for multicenter longitudinal studies with improved potential for generalizing the association between individual nurse staffing levels and NSEs.OBJECTIVE: This study aimed (1) to determine the prevalence, preventability, type, and severity of NSEs; (2) to describe individual patient-level nurse staffing exposure across hospitals; (3) to assess the effect of nurse staffing on NSEs in patients; and (4) to identify thresholds of safe nurse staffing levels and test them against NSEs in hospitalized patients.METHODS: This international multicenter study uses a longitudinal and observational research design; it involves 4 countries (Switzerland, Sweden, Germany, and Iran), with participation from 14 hospitals and 61 medical, surgery, and mixed units. The 16-week observation period will collect NSEs using systematic retrospective record reviews. A total of 3680 patient admissions will be reviewed, with 60 randomly selected admissions per unit. To be included, patients must have been hospitalized for at least 48 hours. Nurse staffing data (ie, the number of nurses and their education level) will be collected daily for each shift to assess the association between NSEs and individual nurse staffing levels. Additionally, hospital data (ie, type, teaching status, and ownership) and unit data (ie, service line and number of beds) will be collected.RESULTS: As of January 2024, the verification process for the plausibility and comprehensibility of patients' and nurse staffing data is underway across all 4 countries. Data analyses are planned to be completed by spring 2024, with the first results expected to be published in late 2024.CONCLUSIONS: This study will provide comprehensive information on NSEs, including their prevalence, preventability, type, and severity, across countries. Moreover, it seeks to enhance understanding of NSE mechanisms and the potential impact of nurse staffing on these events. We will evaluate within- and between-hospital variability to identify productive strategies to ensure safe nurse staffing levels, thereby reducing NSEs in hospitalized patients. The TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) study will focus on the optimization of scarce staffing resources.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56262.
6.	Baker, K., et al. (författare) Automated respiratory rate counter to assess children for symptoms of pneumonia: Protocol for cross-sectional usability and acceptability studies in Ethiopia and Nepal 2020 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 9:3 Tidskriftsartikel (refereegranskat)abstract Background: Manually counting a child's respiratory rate (RR) for 60 seconds using an acute respiratory infection timer is the World Health Organization (WHO) recommended method for detecting fast breathing as a sign of pneumonia. However, counting the RR is challenging and misclassification of an observed rate is common, often leading to inappropriate treatment. To address this gap, the acute respiratory infection diagnostic aid (ARIDA) project was initiated in response to a call for better pneumonia diagnostic aids and aimed to identify and assess automated RR counters for classifying fast breathing pneumonia when used by front-line health workers in resource-limited community settings and health facilities. The Children's Automated Respiration Monitor (ChARM), an automated RR diagnostic aid using accelerometer technology developed by Koninklijke Philips NV, and the Rad-G, a multimodal RR diagnostic and pulse oximeter developed by Masimo, were the two devices tested in these studies conducted in the Southern Nations, Nationalities, and Peoples' Region in Ethiopia and in the Karnali region in Nepal. Objective: In these studies, we aimed to understand the usability of two new automated RR diagnostic aids for community health workers (CHWs; health extension workers [Ethiopia] and female community health volunteers [Nepal]) and their acceptability to CHWs in Ethiopia and Nepal, first-level health facility workers (FLHFWs) in Ethiopia only, and caregivers in both Ethiopia and Nepal. Methods: This was a prospective, cross-sectional study with a mixed methods design. CHWs and FLHFWs were trained to use both devices and provided with refresher training on all WHO requirements to assess fast breathing. Immediately after training, CHWs were observed using ARIDA on two children. Routine pneumonia case management consultations for children aged 5 years and younger and the device used for these consultations between the first and second consultations were recorded by CHWs in their patient log books. CHWs were observed a second time after 2 months. Semistructured interviews were also conducted with CHWs, FLHFWs, and caregivers. The proportion of consultations with children aged 5 years and younger where CHWs using an ARIDA and adhered to all WHO requirements to assess fast breathing and device manufacturer instructions for use after 2 months will be calculated. Qualitative data from semistructured interviews will be analyzed using a thematic framework approach. Results: The ARIDA project was funded in November 2015, and data collection was conducted between April and December 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in 2020. Conclusions: This is the first time the usability and acceptability of automated RR counters in low-resource settings have been evaluated. Outcomes will be relevant for policy makers and are important for future research of this new class of diagnostic aids for the management of children with suspected pneumonia. © Kevin Nicholas Baker, Alice Maurel, Charlotte Ward, Dawit Getachew, Tedila Habte, Cindy McWhorter, Paul LaBarre, Jonas Karlström, Max Petzold, Karin Källander.
7.	Baker, Kevin, et al. (författare) Metadata Correction: Performance, Acceptability, and Usability of Respiratory Rate Timers and Pulse Oximeters When Used by Frontline Health Workers to Detect Symptoms of Pneumonia in Sub-Saharan Africa and Southeast Asia: Protocol for a Two-Phase, Multisite, Mixed-Methods Trial. 2019 Ingår i: JMIR research protocols. - : JMIR Publications Inc.. - 1929-0748. ; 8:3 Tidskriftsartikel (refereegranskat)
8.	Baker, K., et al. (författare) Performance, Acceptability, and Usability of Respiratory Rate Timers and Pulse Oximeters When Used by Frontline Health Workers to Detect Symptoms of Pneumonia in Sub-Saharan Africa and Southeast Asia: Protocol for a Two-Phase, Multisite, Mixed-Methods Trial 2018 Ingår i: JMIR Res Protoc. - : JMIR Publications Inc.. - 1929-0748. ; 7:10 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: Pneumonia is one of the leading causes of death in children aged under 5 years in both sub-Saharan Africa and Southeast Asia. The current diagnostic criterion for pneumonia is based on the increased respiratory rate (RR) in children with cough or difficulty breathing. Low oxygen saturation, measured using pulse oximeters, is indicative of severe pneumonia. Health workers often find it difficult to accurately count the number of breaths, and the current RR counting devices are often difficult to use or unavailable. Nonetheless, improved counting devices and low-cost pulse oximeters are now available on the market. OBJECTIVE: The objective of our study was to identify the most accurate, usable, and acceptable devices for the diagnosis of pneumonia symptoms by community health workers and first-level health facility workers or frontline health workers in resource-poor settings. METHODS: This was a multicenter, prospective, two-stage, observational study to assess the performance and usability or acceptability of 9 potential diagnostic devices when used to detect symptoms of pneumonia in the hands of frontline health workers. Notably, 188 possible devices were ranked and scored, tested for suitability in a laboratory, and 5 pulse oximeters and 4 RR timers were evaluated for usability and performance by frontline health workers in hospital, health facility, and community settings. The performance was evaluated against 2 references over 3 months in Cambodia, Ethiopia, South Sudan, and Uganda. Furthermore, acceptability and usability was subsequently evaluated using both qualitative and quantitative methodologies in routine practice, over 3 months, in the 4 countries. RESULTS: This project was funded in 2014, and data collection has been completed. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. CONCLUSIONS: This is the first large-scale evaluation of tools to detect symptoms of pneumonia at the community level. In addition, selecting an appropriate reference standard against which the devices were measured was challenging given the lack of existing standards and differences of opinions among experts. The findings from this study will help create a standardized and validated protocol for future studies and support further comparative testing of diagnostic devices in these settings. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000348550; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367306&isReview= true (Archived by Website at http://www.webcitation.org/72OcvgBcf). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/10191.
9.	Barbabella, Francesco, et al. (författare) A web-based psychosocial intervention for family caregivers of older people : results from a mixed-methods study in three European countries 2016 Ingår i: JMIR Research Protocols. - : JMIR Publications. - 1929-0748. ; 5:4, s. 1-16 Tidskriftsartikel (refereegranskat)abstract Background: Informal caregiving is the main source of care for older people in Europe. An enormous amount of responsibility and care activity is on the shoulders of family caregivers, who might experience problems in their psychological well-being and in reconciling caregiving and their personal sphere. In order to alleviate such burden, there is increasing interest and growing research in Europe on Web-based support addressing family caregivers and their needs. However, the level of development and penetration of innovative Web-based services for caregivers is still quite low and the access to traditional face-to-face services can be problematic for logistic, availability, and quality reasons.Objective: As part of the European project INNOVAGE, a pilot study was conducted for developing and testing a Web-based psychosocial intervention aimed at empowering family caregivers of older people in Italy, Sweden, and Germany. The program offered information resources and interactive services to enable both professional and peer support.Methods: A mixed-methods, sequential explanatory design was adopted. Caregivers’ psychological well-being, perceived negative and positive aspects of caregiving, and social support received were assessed before and after the 3-month intervention. Poststudy, a subsample of users participated in focus groups to assist in the interpretation of the quantitative results.Results: A total of 94 out of 118 family caregivers (79.7%) from the three countries used the Web platform at least once. The information resources were used to different extents in each country, with Italian users having the lowest median number of visits (5, interquartile range [IQR] 2-8), whereas German users had the highest number (17, IQR 7-66) (P<.001). The interactive services most frequently accessed (more than 12 times) in all countries were the social network (29/73, 40%) and private messages (27/73, 37%). The pretest-posttest analysis revealed some changes, particularly the slight worsening of perceived positive values of caregiving (Carers of Older People in Europe [COPE] positive value subscale: P=.02) and social support received (COPE quality-of-support subscale: P=.02; Multidimensional Scale of Perceived Social Support subscale: P=.04), in all cases with small effect size (r range -.15 to -.18). Focus groups were conducted with 20 family caregivers and the content analysis of discussions identified five main themes: online social support, role awareness, caregiving activities, psychological well-being, and technical concerns. The analysis suggested the intervention was useful and appropriate, also stimulating a better self-efficacy and reappraisal of the caregivers’ role.Conclusions: The intervention seemed to contribute to the improvement of family caregivers’ awareness, efficacy, and empowerment, which in turn may lead to a better self-recognition of their own needs and improved efforts for developing and accessing coping resources. A major implication of the study was the finalization and implementation of the InformCare Web platform in 27 European countries, now publicly accessible (www.eurocarers.org/informcare).
10.	Belfrage, Emma, et al. (författare) Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome (BIO-MUSE) : Protocol for a Translational Study 2024 Ingår i: JMIR Research Protocols. - 1929-0748. ; 13 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: Cutaneous T-cell lymphoma (CTCL) is a rare group of lymphomas that primarily affects the skin. Mycosis fungoides (MF) is the most common form of CTCL and Sézary syndrome (SS) is more infrequent. Early stages (IA-IIA) have a favorable prognosis, while advanced stages (IIB-IVB) have a worse prognosis. Around 25% of patients with early stages of the disease will progress to advanced stages. Malignant skin-infiltrating T-cells in CTCL are accompanied by infiltrates of nonmalignant T-cells and other immune cells that produce cytokines that modulate the inflammation. Skin infection, often with Staphylococcus aureus, is frequent in advanced stages and can lead to sepsis and death. S. aureus has also been reported to contribute to the progression of the disease. Previous reports indicate a shift from Th1 to Th2 cytokine production and dysfunction of the skin barrier in CTCL. Treatment response is highly variable and often unpredictable, and there is a need for new predictive and prognostic biomarkers.OBJECTIVE: This prospective translational study aims to identify prognostic biomarkers in the blood and skin of patients with MF and SS.METHODS: The Predictive and Prognostic Biomarkers in Patients With MF and SS (BIO-MUSE) study aims to recruit 120 adult patients with MF or SS and a control group of 20 healthy volunteers. The treatments will be given according to clinical routine. The sampling of each patient will be performed every 3 months for 3 years. The blood samples will be analyzed for lactate dehydrogenase, immunoglobulin E, interleukins, thymus and activation-regulated chemokine, and lymphocyte subpopulations. The lymphoma microenvironment will be investigated through digital spatial profiling and single-cell RNA sequencing. Microbiological sampling and analysis of skin barrier function will be performed. The life quality parameters will be evaluated. The results will be evaluated by the stage of the disease.RESULTS: Patient inclusion started in 2021 and is still ongoing in 2023, with 18 patients and 20 healthy controls enrolled. The publication of selected translational findings before the publication of the main results of the trial is accepted.CONCLUSIONS: This study aims to investigate blood and skin with a focus on immune cells and the microbiological environment to identify potential new prognostic biomarkers in MF and SS.TRIAL REGISTRATION: ClinicalTrials.gov NCT04904146; https://www.clinicaltrials.gov/study/NCT04904146.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55723.
11.	Bendtsen, Marcus, et al. (författare) Correction: The Effect of Question Order on Outcomes in the Core Outcome Set for Brief Alcohol Interventions Among Online Help-Seekers: Protocol for a Factorial Randomized Trial (vol 10, e26578, 2021) 2021 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc. - 1929-0748. ; 10:2 Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract n/a
12.	Bendtsen, Marcus, et al. (författare) Effects of a Text Messaging Smoking Cessation Intervention Among Online Help Seekers and Primary Health Care Visitors in Sweden: Protocol for a Randomized Controlled Trial Using a Bayesian Group Sequential Design 2020 Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 9:12 Tidskriftsartikel (refereegranskat)abstract Background: A steady decline of the smoking prevalence in Sweden has been recorded over the past decade; however, people still start and continue to smoke. There is a need for effective smoking cessation interventions that can scale to a national level and that are designed to reach individuals requiring smoking cessation support in the general population. Objective: Previous randomized controlled trials of smoking cessation interventions among high school and university students in Sweden have found consistent evidence that text messaging interventions are effective in helping students quit smoking. However, there are no studies that investigate the effects of text messaging interventions in a more general population. The objective of this study is to estimate the effects of a text messaging intervention on individuals seeking help to quit online and individuals visiting primary health care units. Methods: A 2-arm, parallel-group (1:1), randomized controlled trial will be employed to address the study objectives. The trial will follow a Bayesian group sequential design. Recruitment will be conducted using online advertisement (Google, Bing, and Facebook) and through health care professionals at primary health care units. All participants will receive treatment as usual; however, participants who are allocated to the intervention arm will also be given access to a 12-week text message smoking cessation intervention. Primary outcomes are 8-week prolonged abstinence and 4-week point prevalence, measured 3 months and 6 months postrandomization. Mediator variables (self-efficacy, importance, and know-how) will be measured to estimate causal mediation models. Results: Recruitment commenced in September 2020 and will not exceed 24 months. This means that a complete dataset will be available at the latest towards the end of 2022. We expect to publish the findings from this trial by June 2023. Conclusions: This trial will further our understanding of the effects of text messaging interventions among a more general population than has previously been studied. We also aim to learn about differential effects between those who seek support online and those who are given facilitated support at primary health care units. Trial recruitment is limited to the Swedish population; however, a strength of this study is the pragmatic way in which participants are recruited. Through online advertisements, individuals are recruited in reaction to their own interest in seeking help to quit. At primary health care units, individuals who were not necessarily looking for smoking cessation support are given information about the trial. This closely mimics the way the intervention would be disseminated in a real-world setting and may therefore strengthen the argument of generalizability of findings.
13.	Bendtsen, Marcus, 1982-, et al. (författare) Mobile Phone-Based Smoking-Cessation Intervention for Patients Undergoing Elective Surgery : Protocol for a Randomized Controlled Trial 2019 Ingår i: JMIR Research Protocols. - Toronto, Canada : J M I R Publications, Inc.. - 1929-0748. ; 8:3 Tidskriftsartikel (refereegranskat)abstract Background: Several large studies have shown that the risk of cardiovascular, respiratory, and wound-healing complications (including death) within 30 days of surgery is greater for smokers than for nonsmokers. However, there is evidence that even short-term perioperative smoking cessation may reduce postoperative morbidity. Over the past few years, it has become more evident that short message service (SMS)–based interventions can help individuals quit smoking.Objective: The overall aim of this project is to fill the knowledge gap on whether an SMS-based smoking-cessation intervention can be effective in helping patients stop smoking perioperatively. The aim of this trial is to evaluate the effectiveness of an SMS-based intervention on smoking behavior of patients undergoing elective surgery.Methods: A two-arm parallel-group randomized controlled trial will be conducted at 20 surgical departments in southeast Sweden. Smokers undergoing elective surgery who own a mobile phone will be included. Power calculations indicate that it will be necessary to randomize 434 participants. One group will be given access to a novel 12-week SMS program, which includes daily SMS messages with behavior change–enforcing text content and hyperlinks to interactive modules, while the other group will not be given access to the intervention. Both groups will have access to the surgical departments’ current routine for smoking cessation prior to surgery. Primary outcome measures, prolonged abstinence, and point prevalence of smoking cessation will be measured through questionnaires at 3, 6, and 12 months after randomization. Logistic regression models adjusted using baseline characteristics will be explored to identify potential effects of the intervention.Results: Recruitment started in late October 2018 and is expected to last for a maximum of 30 months. The first results are expected to be available approximately 3 months after the final date of recruitment.Conclusions: Owing to the structural problems and scarcity of time and resources, patients at most Swedish surgical departments are simply instructed to quit smoking, and perhaps, referred to a primary health care clinic. An SMS-based smoking-cessation aid can be effective in helping individuals quit smoking and is a very simple and time-efficient tool for surgical departments to use.
14.	Bendtsen, Marcus, 1982-, et al. (författare) Reducing Alcohol Consumption Among Risky Drinkers in the General Population of Sweden Using an Interactive Mobile Health Intervention : Protocol for a Randomized Controlled Trial 2019 Ingår i: JMIR Research Protocols. - Toronto, Canada : J M I R Publications, Inc.. - 1929-0748. ; 8:4 Tidskriftsartikel (refereegranskat)abstract Background: Harmful use of alcohol continues to be a leading contributor to premature deaths globally. Not only does harmful drinking have consequences for the individuals consuming at increased levels, but it may also result in a range of negative consequences for their family members and friends. Interventions delivered via mobile phones (mobile health [mHealth] interventions) could potentially support risky drinkers seeking help to reduce their alcohol consumption.Objective: This protocol describes a randomized controlled trial that aims to validly estimate the effect of a novel mHealth intervention targeting risky drinkers in the general population of Sweden. Nested within the trial are 3 substudies that focus on methodological and user satisfaction research questions.Methods: A 2-arm parallel group randomized controlled trial will be employed to estimate the effect of the novel intervention. Participants will be recruited through Web advertisements and social media. The inclusion criteria are as follows: 18 years or older, ownership of a mobile phone, and being classified as a risky drinker according to Swedish guidelines. Participants allocated to the intervention group will receive a novel mHealth intervention. The intervention consists of weekly screening, personalized feedback on current consumption, functions allowing for planning of future consumption, as well as a series of messages delivered throughout the week. Participants allocated to the control group will receive a short message regarding negative consequences of alcohol consumption and a hyperlink that offers more information. Following 2 and 4 months after randomization, both groups will be asked to complete follow-up questionnaires (2-month interval being primary). Primary outcomes are weekly alcohol consumption and heavy episodic drinking. Participants in the control group will be given access to the novel intervention after completing the 4-month follow-up. The trial includes 3 substudies: We will explore whether the mode of presenting information before participants giving informed consent affects participation rates and recall of trial parameters, investigate if the content of the short message received by the control group affects study outcomes and requests for more information, and explore user satisfaction with the intervention and reactions of the control group.Results: Participant recruitment is planned to begin in April 2019 and to last for a maximum of 24 months. The first dataset will be available approximately 2 months after the final participant has been recruited, and the final dataset will be available approximately 2 months later. No participants had been recruited at the time of submitting this protocol.Conclusions: If found effective, the intervention has the potential to reduce negative consequences of alcohol consumption for individuals. The technology has been designed to have potential for extensive reach among those who may benefit.
15.	Bendtsen, Marcus, 1982- (författare) Text Messaging Interventions for Reducing Alcohol Consumption Among Harmful and Hazardous Drinkers : Protocol for a Systematic Review and Meta-Analysis 2019 Ingår i: JMIR Research Protocols. - Toronto, Canada : J M I R Publications, Inc.. - 1929-0748. ; 8:4 Tidskriftsartikel (refereegranskat)abstract Background: Mobile phone-based interventions have become popular for lifestyle behavior change, particularly the use of text messaging as it is a technology ubiquitous in mobile phones. Reviews and meta-analyses of digital interventions for reducing harmful and hazardous use of alcohol have mainly focused on Web-based interventions; thus, there is a need for a body of evidence to guide health practitioners, policy makers, and researchers with respect to the efficacy of available text messaging interventions.Objective: The aim of this systematic review and meta-analysis is to assess the effectiveness of text messaging interventions for reducing the amount of alcohol consumed among harmful and hazardous drinkers; this is compared to receiving no, minimal, or unrelated health information. Specifically, we ask the following questions: (1) Can interventions consisting of only text messages be effective in reducing alcohol consumption compared to no intervention or a minimal or unrelated intervention? (2) Can interventions consisting of only text messages be effective in reducing the prevalence of risky drinking compared to no intervention or a minimal or unrelated intervention?Methods: Several databases will be searched, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PsycINFO, the Conference Proceedings Citation Index, ClinicalTrials.gov, OpenGrey, among others. Reports of studies that evaluate text messaging interventions for reducing the amount of alcohol consumed will be included. Primary outcomes of interest will be weekly alcohol consumption and frequency of heavy episodic drinking. The Cochrane Collaboration Risk of Bias tool will be used to assess bias in reports, and the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach will be used to assess the quality of the body of evidence. A narrative review will be presented, and a meta-analysis will be conducted in case of homogeneity among included studies.Results: The systematic review has not yet begun but is expected to start in May of 2019; publication of the final review and meta-analysis is expected at the end of 2019.Conclusions: The technology for text messaging is ubiquitous in mobile phones; thus, the potential reach of interventions utilizing this technique is great. However, there are no meta-analyses to date that limit the scope to the use of text messaging interventions for alcohol consumption reduction. Therefore, the proposed systematic review and meta-analysis will help health practitioners, policy decision makers, researchers, and others to better understand the effects of these interventions.
16.	Bendtsen, Marcus, et al. (författare) The Effect of Question Order on Outcomes in the Core Outcome Set for Brief Alcohol Interventions Among Online Help-Seekers: Protocol for a Factorial Randomized Trial 2020 Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 9:11 Tidskriftsartikel (refereegranskat)abstract Background: A core outcome set (COS) for trials and evaluations of the effectiveness and efficacy of alcohol brief interventions (ABIs) has recently been established through international consensus to address the variability of outcomes evaluated. Objective: This is a protocol for studies to assess if there are order effects among the questions included in the COS. Methods: The 10 items of the COS are organized into 4 clusters. A factorial design will be used with 24 arms, where each arm represents 1 order of the 4 clusters. Individuals searching online for help will be asked to complete a questionnaire, and consenting participants will be randomized to 1 of the 24 arms (double-blind with equal allocation). Participants will be included if they are 18 years or older. The primary analyses will (1) estimate how the order of the clusters of outcomes affects how participants respond and (2) investigate patterns of abandonment of the questionnaire. Results: Data collection is expected to commence in November 2020. A Bayesian group sequential design will be used with interim analyses planned for every 50 participants completing the questionnaire Data collection will end no more than 24 months after commencement, and the results are expected to be published no later than December 2023. Conclusions: Homogenizing the outcomes evaluated in studies of ABIs is important to support synthesis, and the COS is an important step toward this goal. Determining whether there may be issues with the COS question order may improve confidence in using it and speed up its dissemination in the research community We encourage others to adopt the protocol as a study within their trial as they adopt the ORBITAL (Outcome Reporting in Brief Intervention Trials: Alcohol) COS to build a worldwide repository and provide materials to support such analysis.
17.	Bendtsen, Marcus, 1982-, et al. (författare) The Mobile Health Multiple Lifestyle Behavior Interventions Across the Lifespan (MoBILE) Research Program : Protocol for Development, Evaluation, and Implementation 2020 Ingår i: JMIR Research Protocols. - Toronto, Canada : JMIR Publications Inc. - 1929-0748. ; 9:4 Tidskriftsartikel (refereegranskat)abstract Background: Clustering of multiple lifestyle risk behaviors has been associated with a greater risk of noncommunicable diseases and mortality than one lifestyle risk behavior or no lifestyle risk behaviors. The National Board of Health and Welfare in Sweden reported in 2018 that it is important to provide additional support to individuals with multiple lifestyle risk behaviors, as risks from these behaviors are multiplicative rather than additive. However, the same report emphasized that there is a lack of knowledge regarding interventions that support changes to unhealthy lifestyle behaviors.Objective: The MoBILE (Mobile health Multiple lifestyle Behavior Interventions across the LifEspan) research program has brought together two Swedish research groups supported by international collaborators. Through this collaboration, we aim to design and evaluate a number of novel and tailored mobile health (mHealth) multiple lifestyle behavior interventions across the life span of different health care populations. In addition, the MoBILE research program will extend ongoing research to include mHealth interventions for migrant pregnant women and children.Methods: Each project within the MoBILE program will focus on a specific group: pregnant women, preschool children, high school and university students, and adults in primary and clinical care. All the projects will follow the same 4 phases: requirements, development, evaluation, and implementation. During the requirements phase, implementers and end users will aid the design of content and functionality of the interventions. In the development phase, findings from the first phase will be synthesized with expert domain knowledge and theoretical constructs to create interventions tailored to the target groups. The third phase, evaluation, will comprise randomized controlled trials conducted to estimate the effects of the interventions on multiple lifestyle risk behaviors (eg, alcohol, nutrition, physical activity, and smoking). The final phase will investigate how the interventions, if found effective, can be disseminated into different health care contexts.Results: The research program commenced in 2019, and the first results will be available in 2020. Projects involving pregnant women, preschool children, and high school and university students will be completed in the first 3 years, with the remaining projects being planned for the program’s final 3 years.Conclusions:The development of evidence-based digital tools is complex, as they should be guided by theoretical frameworks, and requires large interdisciplinary teams with competence in technology, behavioral science, and lifestyle-specific areas. Individual researchers or smaller research groups developing their own tools is not the way forward, as it means reinventing the wheel over and over again. The MoBILE research program therefore aims to join forces and learn from the past 10 years of mHealth research to maximize scientific outcomes, as well as the use of financial resources to expand the growing body of evidence for mHealth lifestyle behavior interventions.
18.	Berbyuk Lindström, Nataliya, 1978, et al. (författare) Person- and Family-Centeredness in Ethiopian Cancer Care: Improving Communication, Ethics, Decision Making and Health 2020 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 9:5 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: Cancer is a major burden in Ethiopia. The Oncology Department of Tikur Anbessa (Black Lion) Specialized Hospital (TASH) in Addis Ababa is the country's sole specialist unit for cancer care. With only a handful of oncologists, a lack of resources, and a huge patient load, the work is challenging, especially in terms of achieving effective and ethical patient consultations. Patients, usually accompanied by family members, often wait for a long time to receive medical attention and frequently depart without treatment. Handling consultations effectively is essential in order to help patients as much as possible within such limitations. OBJECTIVE: The project addresses three main aims: (1) to enhance and expand the understanding of communicative and associated ethical challenges in Ethiopian cancer care; (2) to enhance and expand the understanding of the implications and use of person- and family-centered solutions to address such communicative challenges in practice, and (3) to plan and evaluate interventions in this area. METHODS: This project develops and consolidates a research collaboration to better understand and mitigate the communicative challenges in Ethiopian cancer care, with a focus on the handling and sharing of decision making, and ethical tensions between patients, staff, and family. Using theoretical models from linguistics, health communication, and health care ethics, multiple sources of data will be analyzed. Data sources currently include semi-structured interviews with the Ethiopian staff, patients, and family caregivers (91), survey data on cancer awareness (150) and attitudes to breaking bad news (450), and video-recordings of medical consultations (45). In addition, we will also develop clinical and methodological solutions to formulate educational interventions. RESULTS: The project was awarded funding by the Swedish Research Council in December 2017 for the period 2018-2021. The research ethics board in Sweden and in Ethiopia approved the conduct of the project in May 2018. The results from the studies will be published in 2020 and 2021. CONCLUSIONS: The project is a first step towards producing unique and seminal knowledge for the specific context of Ethiopia in the area of physician-patient communication research and ethics. It contributes to an understanding of the complexity around the role of family and ethical challenges in relation to patient involvement and decision making in Ethiopia. Improved knowledge in this area can provide a fundamental model for ways to improve cancer care in many other low resource settings in Africa and the Middle East, which share central cultural prerequisites (such as a strong patriarchal family structure, combined with strong and devout religiosity). The project will also serve to develop greater understanding about current challenges in Western health systems associated with greater family and patient participation in decision making. In addition, the project will also contribute to improving the education of Ethiopian health professionals working in cancer care by developing a training program to help them better understand and respond to identified challenges associated with communication.
19.	Bergman Nordgren, Lise, 1983-, et al. (författare) Role of the Working Alliance on Treatment Outcome in Tailored Internet-Based Cognitive Behavioural Therapy for Anxiety Disorders : Randomized Controlled Pilot Trial 2013 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 2:1 Tidskriftsartikel (refereegranskat)abstract Background: Internet-based cognitive behavioral therapy (ICBT) is a form of guided self-help that has been found to be effective for addressing several problems. The target for this type of therapy is usually restricted to one specific disorder. Tailoring the treatment widens the scope of ICBT in that it can address comorbid conditions directly. Objectives: The working, or therapeutic, alliance has been found to predict outcome in studies of face-to-face therapy. The extent to which these findings apply to ICBT is largely unknown. We therefore decided to find out whether the working alliance could predict outcome in tailored ICBT for anxiety disorders. Methods: Data were obtained from the treatment group (n=27) in a randomized controlled trial aiming to test the effects of tailored ICBT for anxiety disorders. The forthcoming study was designed to test the hypothesis that the working alliance measured both pre-treatment and early in treatment (week 3) can predict treatment outcome as measured by the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) in a heterogeneous group of patients with anxiety disorders (n=27). Results: Working alliance measured at week 3 into the treatment correlated significantly with the residual gain scores on the primary outcome measure (r=-.47, P=.019, n=25), while expected working alliance pre-treatment did not (r=-.17, P=.42, n=27). Conclusions: These results raise questions about the importance of working alliance in ICBT treatments, and suggest that the working alliance could be important in ICBT.
20.	Berman, Anne H., et al. (författare) Mobile phone apps for university students with hazardous alcohol use : study protocol for two consecutive randomized controlled trials 2015 Ingår i: JMIR Research Protocols. - : JMIR Publications. - 1929-0748. ; 4:4 Tidskriftsartikel (refereegranskat)abstract Background: About 50% of university students overconsume alcohol, and drinking habits in later adulthood are to some extent established during higher educational studies. Several studies have demonstrated that Internet-based interventions have positive effects on drinking habits among university students. Our recent study evaluated two mobile phone apps targeting drinking choices at party occasions via personalized feedback on estimated blood alcohol concentration (eBAC) for students with hazardous drinking. No changes in drinking parameters were found over a seven-week period apart from an increase in number of drinking occasions among men for one of the apps tested. Up to 30% of the study participants drank at potentially harmful levels: higher than the national recommended number of standard drinks per week (a maximum of 9 for women and 14 for men) in Sweden. Objective: (1) To evaluate improved versions of the two mobile phone apps tested in our prior trial, in a new, 3-armed randomized controlled trial among university students with at least hazardous drinking habits according to the Alcohol Use Disorders Identifications Test (AUDIT; Study 1). (2) After 6 weeks, to target study participants showing alcohol consumption higher than the national recommended levels for standard drinks per week by offering them participation in a second, 2-armed randomized trial evaluating an additional mobile phone app with skill enhancement tasks (Study 2). (3) To follow participants at 6, 12 and 18 weeks after recruitment to Study 1 and at 6 and 12 weeks after recruitment to Study 2. Methods: Two randomized controlled trials are conducted. Study 1: Students are recruited at four Swedish universities, via direct e-mail and advertisements on Facebook and student union web sites. Those who provide informed consent, have a mobile phone, and show at least hazardous alcohol consumption according to the AUDIT (≥6 for women; ≥8 points for men) are randomized into three groups. Group 1 has access to the Swedish government alcohol monopoly’s app, Promillekoll, offering real-time estimated eBAC calculation; Group 2 has access to a Web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants are controls. Follow-up is conducted at 6, 12 and 18 weeks. Study 2. Participants who at the first 6-week follow-up show drinking levels higher than 9 (W) or 14 (M) standard drinks (12 g alcohol) per week, are offered participation in Study 2. Those who consent are randomized to either access to a skills training app, TeleCoach or to a wait-list control group. Results: Latent Markov models for Study 1 and mixed models analyses for Study 2 will be performed. Study 2 data will be analyzed for publication during the spring of 2016; Study 1 data will be analyzed for publication during the fall of 2016. Conclusions: If mobile phone interventions for reducing hazardous alcohol use are found to be effective, the prospects for positively influencing substance use-related health among university students can considerably improve.
21.	Bjerkan, Jorunn, et al. (författare) Citizen-Patient Involvement in the Development of mHealth Technology : Protocol for a Systematic Scoping Review 2020 Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS. - 1929-0748. ; 9:8 Forskningsöversikt (refereegranskat)abstract Background: The development of mobile technology for information retrieval and communication, both at individual and health organizational levels, has been extensive over the last decade. Mobile health (mHealth) technology is rapidly adapting to the health care service contexts to improve treatment, care, and effectiveness in health care services. Objective: The overall aim of this scoping review is to explore the role of citizen-patient involvement in the development of mHealth technology in order to inform future interventions. By identifying key characteristics of citizen-patient involvement in system development, we aim to improve digital communication and collaboration between health care providers and citizen-patients, including sharing of health care data. Methods: The systematic scoping review will follow the Joanna Briggs Institute methodology for scoping reviews by searching literature in 3 steps. We will include literature reporting on the public, citizens, and patients participating in the development of mobile technology for health care purposes in MEDLINE, CINAHL, Scopus, EMBASE, and ProQuest Dissertations and Theses. A preliminary search was completed in MEDLINE and Scopus. The screening process will be conducted by 2 of the authors. Data will be extracted using a data extraction tool prepared for the study. Results: The study is expected to identify research gaps that will inform and motivate the development of mHealth technology. The final report is planned for submission to an indexed journal in November 2020. Conclusions: To our knowledge, this review will be the first review to provide knowledge about how citizen-patients participate in system developments for mHealth tools and the value that such involvement adds to the system development process.
22.	Bonn, Stephanie Erika, et al. (författare) A Validation Study of the Web-Based Physical Activity Questionnaire Active-Q Against the GENEA Accelerometer 2015 Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 4:3 Tidskriftsartikel (refereegranskat)abstract Background: Valid physical activity assessment in epidemiological studies is essential to study associations with various health outcomes. Objective: To validate the Web-based physical activity questionnaire Active-Q by comparing results of time spent at different physical activity levels with results from the GENEA accelerometer and to assess the reproducibility of Active-Q by comparing two admissions of the questionnaire Methods: A total of 148 men (aged 33 to 86 years) responded to Active-Q twice and wore the accelerometer during seven consecutive days on two occasions. Time spent on six different physical activity levels including sedentary, light (LPA), moderate (MPA), and vigorous (WA) as well as additional combined categories of sedentary-to-light and moderate-to-vigorous (MVPA) physical activity was assessed. Validity of Active-Q was determined using Spearman correlation coefficients with 95% confidence intervals (CI) and the Bland-Altman method. Reproducibility was assessed using intraclass correlation coefficients (ICCs) comparing two admissions of the questionnaire Results: The validity correlation coefficients were statistically significant for time spent at all activity levels; sedentary (r=0.19, 95% CI: 0.04-0.34), LPA (r=0.15, 95% CI: 0.00-0.31), sedentary-to-light (r=0.35, 95% CI: 0.19-0.51), MPA (r=0.27, 95% CI: 0.12-0.42), WA (r=0.54, 95% CI: 0.42-0.67), and MVPA (r=0.35, 95% CI: 0.21-0.48). The Bland-Altman plots showed a negative mean difference for time in LPA and positive mean differences for time spent in MPA, WA and MVPA. The ICCs of test-retest reliability ranged between r=0.51-0.80 for the different activity levels in Active-Q. Conclusions: More moderate and vigorous activities and less light activities were reported in Active-Q compared to accelerometer measurements. Active-Q shows comparable validity and reproducibility to other physical activity questionnaires used today.
23.	Bonn, Stephanie Erika, et al. (författare) App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial 2020 Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 9:8 Tidskriftsartikel (refereegranskat)abstract Background: To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. Objective: The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. Methods: The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. Results: A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. Conclusions: Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients.
24.	Brennan, M. T., et al. (författare) Impact of Oral Side Effects from Conditioning Therapy Before Hematopoietic Stem Cell Transplantation: Protocol for a Multicenter Study 2018 Ingår i: Jmir Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 7:4 Tidskriftsartikel (refereegranskat)abstract Background: The oral cavity is a common site of complications related to the cytotoxic effect of high-dose chemotherapy and radiation therapy. Considering our limited understanding of the burden of illness in the oral cavity from various cytotoxic therapies, it is difficult to produce evidence-based, preventive and management protocols. A prospective multicenter study is necessary to collect data on the burden of illness from various cytotoxic regimens. Objective: The objectives of this prospective international observational multicenter study in hematopoietic stem cell transplant (HSCT) patients are to establish the nature, incidence and temporal relationship of oral complications related to conditioning regimens (chemotherapy with or without total body irradiation), stem cell transplantation and the immunologic reactions (mainly graft-vs-host-disease) that may follow, and to determine what subjective and objective oral complications related to treatment can predict negative clinical and economic outcomes and reduced quality of life. Methods: Adult patients at six study sites receiving full intensity conditioning, reduced intensity conditioning or nonmyeloablative conditioning, followed by autologous or allogeneic hematopoietic stem cell infusion, are included. A pre-treatment assessment includes medical conditions, planned chemo- and radiation therapy regimen, medications, allergies, social history, patient report of oral problems, dental history, subjective oral complaints, objective measures of oral conditions, current laboratory values, dental treatment recommended and untreated dental disease. Starting 1-3 days after hematopoietic stem cell infusion, a bedside assessment is completed 3 days per week until resolution of neutropenia. A patient questionnaire is also completed during hospitalization. Beyond this time, patients with continued oral mucositis or other oral problems are followed 1 day per week in an inpatient or outpatient setting. Additional visits for urgent care for acute oral problems after hospitalization are documented. Autologous transplant patients are being followed up at 100 days (SD 30 days) and at 1 year (SD 30 days) post-transplantation to identify any long-term side effects. Patients treated with allogeneic transplantation are being followed at 100 days (SD 30 days), 6 months (SD 30 days), and 12 months (SD 30 days). The follow-up assessments include cancer response to therapy, current medical conditions, medications, subjective and objective oral findings, quality of life measures and laboratory values. The targeted enrollment is 254 patients who have received HSCT. Results: A total of 260 participants have been enrolled, with 233 (91%) who have received HSCT. We anticipate enrollment of 20-30 additional participants to obtain the sample size of 254 enrolled participants who have received HSCT. Conclusions: The results of the ongoing prospective study will provide a unique dataset to understand the impact of oral complications on patients undergoing HSCT and provide needed evidence for guidelines regarding the management of this patient cohort.
25.	Calaminus, Gabriele, et al. (författare) Quality of life of patients with osteosarcoma in the european american osteosarcoma study-1 (EURAMOS-1) : Development and implementation of a questionnaire substudy 2019 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 8:9 Tidskriftsartikel (refereegranskat)abstract Background: The quality of life (QoL) of patients with osteosarcoma (OS) may be adversely affected by the disease or its treatment. Therefore, it is important to understand the QoL of patients undergoing treatment for OS to improve the QoL. We report on the first prospective international QoL study that was embedded within a large randomized clinical trial from 4 national study groups. Objective: This paper aimed to describe the QoL study development, methodology, accrual details, and characteristics of the QoL cohort. Methods: A total of 2260 patients registered in the EURopean AMerican Osteosarcoma Study-1 (EURAMOS-1), of whom 97.92% (2213/2260) were eligible for the optional QoL assessment and could participate in terms of questionnaire availability. Overall, 61.86% (1369/2213) of patients and/or proxies completed the QoL evaluation at the first assessment time point (E1) after the start of preoperative treatment. The QoL measures used (self- and/or proxy reports) depending on the patient’s age and national study group. Participants and nonparticipants in the ancillary QoL study were compared regarding relevant demographic and disease-related characteristics at registration in the trial. Results: The participation rate at time point E1 did not differ with regard to age, gender, the occurrence of pathological fracture, or the presence of any metastases at diagnosis. No differences were found regarding the primary tumor site. Only the national study group affiliation had an influence on participation. Participation decreased linearly with trial progress up to 20% at the final time point of QoL assessment. Conclusions: This study demonstrates the feasibility of international cooperation for the purpose of assessing and understanding the QoL of pediatric and adolescent/young adult patients with cancer. Future outcomes of this QoL substudy will help to adapt interventions to improve QoL.
26.	Chiwanga, Faraja S., et al. (författare) An mHealth Intervention to Improve Guardians' Adherence to Children's Follow-Up Care for Acute Lymphoblastic Leukemia in Tanzania (GuardiansCan Project) : Protocol for a Development and Feasibility Study 2023 Ingår i: JMIR Research Protocols. - : JMIR Publications. - 1929-0748. ; 12 Tidskriftsartikel (refereegranskat)abstract Background: Cancer is a leading cause of death during childhood and in low- and middle-income countries survival rates can be as low as 20%. A leading reason for low childhood cancer survival rates in low- and middle-income countries such as Tanzania is treatment abandonment. Contributing factors include poor communication between health care providers and children's guardians, insufficient cancer knowledge, and psychological distress.Objective: Our aim is to respond to Tanzanian guardians' poor adherence to children's follow-up care after treatment for acute lymphoblastic leukemia with the help of mobile health (mHealth) technology. Our goal is to increase guardians' adherence to children's medications and follow-up visits and to decrease their psychological distress.Methods: Following the Medical Research Council framework for developing and evaluating complex interventions, we will undertake the GuardiansCan project in an iterative phased approach to develop an mHealth intervention for subsequent testing. Public contribution activities will be implemented throughout via the establishment of a Guardians Advisory Board consisting of guardians of children with acute lymphoblastic leukemia. We will examine the acceptability, feasibility, and perceived impact of Guardians Advisory Board activities via an impact log and semistructured interviews (study I). In phase 1 (intervention development) we will explore guardians' needs and preferences for the provision of follow-up care reminders, information, and emotional support using focus group discussions and photovoice (study II). We will then co-design the mHealth intervention with guardians, health care professionals, and technology experts using participatory action research (study III). In phase 2 (feasibility), we will examine clinical, methodological, and procedural uncertainties associated with the intervention and study procedures to prepare for the design and conduct of a future definitive randomized controlled trial using a single-arm pre-post mixed methods feasibility study (study IV).Results: Data collection for the GuardiansCan project is anticipated to take 3 years. We plan to commence study I by recruiting Guardians Advisory Board members in the autumn of 2023.Conclusions: By systematically following the intervention development and feasibility phases of the Medical Research Council Framework, and working alongside an advisory board of guardians, we intend to develop an acceptable, culturally appropriate, feasible, and relevant mHealth intervention with the potential to increase guardians' adherence to children's follow-up care after treatment of acute lymphoblastic leukemia, leading to a positive impact on children's health and chances to survive, and reducing distress for guardians.
27.	Chomutare, Taridzo, et al. (författare) Improving Quality of ICD-10 (International Statistical Classification of Diseases, Tenth Revision) Coding Using AI : Protocol for a Crossover Randomized Controlled Trial 2024 Ingår i: JMIR Research Protocols. - 1929-0748. ; 13 Tidskriftsartikel (refereegranskat)abstract Background: Computer-assisted clinical coding (CAC) tools are designed to help clinical coders assign standardized codes, such as the ICD-10 (International Statistical Classification of Diseases, Tenth Revision), to clinical texts, such as discharge summaries. Maintaining the integrity of these standardized codes is important both for the functioning of health systems and for ensuring data used for secondary purposes are of high quality. Clinical coding is an error-prone cumbersome task, and the complexity of modern classification systems such as the ICD-11 (International Classification of Diseases, Eleventh Revision) presents significant barriers to implementation. To date, there have only been a few user studies; therefore, our understanding is still limited regarding the role CAC systems can play in reducing the burden of coding and improving the overall quality of coding. Objective: The objective of the user study is to generate both qualitative and quantitative data for measuring the usefulness of a CAC system, Easy-ICD, that was developed for recommending ICD-10 codes. Specifically, our goal is to assess whether our tool can reduce the burden on clinical coders and also improve coding quality. Methods: The user study is based on a crossover randomized controlled trial study design, where we measure the performance of clinical coders when they use our CAC tool versus when they do not. Performance is measured by the time it takes them to assign codes to both simple and complex clinical texts as well as the coding quality, that is, the accuracy of code assignment. Results: We expect the study to provide us with a measurement of the effectiveness of the CAC system compared to manual coding processes, both in terms of time use and coding quality. Positive outcomes from this study will imply that CAC tools hold the potential to reduce the burden on health care staff and will have major implications for the adoption of artificial intelligence-based CAC innovations to improve coding practice. Expected results to be published summer 2024. Conclusions: The planned user study promises a greater understanding of the impact CAC systems might have on clinical coding in real-life settings, especially with regard to coding time and quality. Further, the study may add new insights on how to meaningfully exploit current clinical text mining capabilities, with a view to reducing the burden on clinical coders, thus lowering the barriers and paving a more sustainable path to the adoption of modern coding systems, such as the new ICD-11.
28.	Crockett, Katie, et al. (författare) Experiences of Health Care Access Challenges for Back Pain Care Across the Rural-Urban Continuum in Canada: Protocol for Cross-sectional Research 2022 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 11:12 Tidskriftsartikel (refereegranskat)abstract Background: Back pain is common and costly, with negative impacts on both individuals and the health care system. Rural, remote, and Indigenous populations are at greater risk of experiencing back pain compared to urban and non-Indigenous populations. Potential barriers to health care access among Canadians with chronic back pain (CBP) have been identified; however, no study has used lived experiences of people with CBP to drive the selection, analysis, and interpretation of variables most meaningful to patients. Objective: The aims of this study are to (1) engage with rural, remote, and urban Indigenous and non-Indigenous patients, health care providers, and health system decision makers to explore lived experiences among people with CBP in Saskatchewan, Canada; (2) cocreate meaningful indicators of CBP care access and effectiveness; and (3) identify program and policy recommendations to overcome access barriers to CBP care. Methods: In phase 1, one-on-one interviews with 30 people with current or past CBP and 10 health care providers residing or practicing in rural, remote, or urban Saskatchewan communities will be conducted. We will recruit Indigenous (n=10) and non-Indigenous (n=20) rural, remote, and urban people. In phase 2, findings from the interviews will inform development of a population-based telephone survey focused on access to health care barriers and facilitators among rural, remote, and urban people; this survey will be administered to 383 residents with CBP across Saskatchewan. In phase 3, phase 1 and 2 findings will be presented to provincial and national policy makers; health system decision makers; health care providers; rural, remote, and urban people with CBP and their communities; and other knowledge users at an interactive end-of-project knowledge translation event. A World Café method will facilitate interactive dialogue designed to catalyze future patient-oriented research and pathways to improve access to CBP care. Patient engagement will be conducted, wherein people with lived experience of CBP, including Indigenous and non-Indigenous people from rural, remote, and urban communities (ie, patient partners), are equal members of the research team. Patient partners are engaged throughout the research process, providing unique knowledge to ensure more comprehensive collection of data while shaping culturally appropriate messages and methods of sharing findings to knowledge users. Results: Participant recruitment began in January 2021. Phase 1 interviews occurred between January 2021 and September 2022. Phase 2 phone survey was administered in May 2022. Final results are anticipated in late 2022. Conclusions: This study will privilege patient experiences to better understand current health care use and potential access challenges and facilitators among rural, remote, and urban people with CBP in Saskatchewan. We aim to inform the development of comprehensive measures that will be sensitive to geographical location and relevant to culturally diverse people with CBP, ultimately leading to enhanced access to more patient-centered care for CBP. International Registered Report Identifier (IRRID): DERR1-10.2196/42484
29.	Crowley, Patrick, et al. (författare) The Surveillance of Physical Activity, Sedentary Behavior, and Sleep : Protocol for the Development and Feasibility Evaluation of a Novel Measurement System 2022 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 11:6 Tidskriftsartikel (refereegranskat)abstract Background: There is increasing recognition of the need for more comprehensive surveillance data, including information on physical activity of all intensities, sedentary behavior, and sleep. However, meeting this need poses significant challenges for current surveillance systems, which are mainly reliant on self-report.Objective: The primary objective of this project is to develop and evaluate the feasibility of a sensor-based system for use in the surveillance of physical activity, sedentary behavior, and sleep (SurPASS) at a national level in Denmark.Methods: The SurPASS project involves an international, multidisciplinary team of researchers collaborating with an industrial partner. The SurPASS system consists of (1) a thigh-worn accelerometer with Bluetooth connectivity, (2) a smartphone app, (3) an integrated back end, facilitating the automated upload, analysis, storage, and provision of individualized feedback in a manner compliant with European Union regulations on data privacy, and (4) an administrator web interface (web application) to monitor progress. The system development and evaluation will be performed in 3 phases. These phases will include gathering user input and specifications (phase 1), the iterative development, evaluation, and refinement of the system (phase 2), and the feasibility evaluation (phase 3).Results: The project started in September 2020 and completed phase 2 in February 2022. Phase 3 began in March 2022 and results will be made available in 2023.Conclusions: If feasible, the SurPASS system could be a catalyst toward large-scale, sensor-based surveillance of physical activity, sedentary behavior, and sleep. It could also be adapted for cohort and interventional research, thus contributing to the generation of evidence for both interventions and public health policies and recommendations.International Registered Report Identifier (IRRID): DERR1-10.2196/35697
30.	Dahlberg, Karuna, 1979-, et al. (författare) 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 2016 Ingår i: JMIR Research Protocols. - Toronto, Canada : JMIR Publications, Inc. - 1929-0748. ; 5:3 Tidskriftsartikel (refereegranskat)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.
31.	Dahlberg, Leif, et al. (författare) A Web-Based Platform for Patients With Osteoarthritis of the Hip and Knee: A Pilot Study 2016 Ingår i: Jmir Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 5:2 Tidskriftsartikel (refereegranskat)abstract Background: Chronic conditions are the leading cause of disability throughout the world and the most expensive problem facing the health care systems. One such chronic condition is osteoarthritis (OA), a frequent cause of major disability. Objective: To describe the effect on joint pain for the first users of a newly developed Web-based osteoarthritis self-managing program, Joint Academy, and to examine whether these patients would recommend other OA patients to use the program. Methods: Patients with clinically established knee or hip OA according to national and international guidelines were recruited from an online advertisement. A trained physiotherapist screened the eligible patients by scrutinizing their answers to a standardized questionnaire. The 6-week program consisted of eight 2- to 5-minute videos with lectures about OA, effects of physical activity, self-management, and coping strategies. In addition, exercises to improve lower extremity physical function were introduced in daily video activities. During the course of the program, communication between physiotherapist and patients was based on an asynchronous chat. After 6 weeks, patients were able to continue without support from the physiotherapist. Patients reported their current pain weekly by using a numeric rating scale (range 0-10; 0=no pain, 10=worst possible pain) as long as they were in the program. In addition, after 6 weeks patients answered the question "What is the probability that you would recommend Joint Academy to a friend?" Results: The eligible cohort consisted of 53 individuals (39 women; body mass index: mean 27, SD 5; age: mean 57, SD 14 years). With the continued use of the program, patients reported a constant change in pain score from mean 5.1 (SD 2.1) at baseline to mean 3.6 (SD 2.0) at week 12. Six patients participated for 30 weeks (mean 3.2, SD 2.1). Overall, the patients would highly recommend Joint Academy to other OA patients, suggesting that the platform may be useful for at least some in the vast OA population. Conclusions: Joint Academy, a Web-based platform for OA therapy, has the potential to successfully deliver individualized online treatment to many patients with OA that presently lack access to treatment.
32.	Dragioti, Elena, Ph.D., et al. (författare) Reported outcomes in published systematic reviews of interdisciplinary pain treatment: Protocol for a systematic overview 2020 Ingår i: JMIR Research Protocols. - : JMIR Publications. - 1929-0748. ; 9:5 Forskningsöversikt (refereegranskat)abstract Background: Interdisciplinary pain treatment (IPT) is a complex intervention; its outcomes are very diverse, as are the methodologies for handling those outcomes. This diversity may hamper evidence-based decision making. Presently, there is no gold standard recommendation of how to select reported outcomes in published systematic reviews and meta-analyses to explicitly demonstrate the effectiveness of IPT. Objective: In this systematic overview, we aim to evaluate the reported outcome domains and measurements across published systematic reviews and meta-analyses and to identify any methods, considerations, and discussion regarding the handling of the chosen outcome domains and measurements. Methods: This article describes the protocol for a systematic overview of the outcomes reported in published systematic reviews and meta-analyses of randomized control trials for the effectiveness of IPT versus any control. To this end, we searched the PubMed, Cochrane Library, and Epistemonikos databases from inception to December 2019. Two independent investigators screened the titles, the abstracts of the identified records, and the full texts of the potentially eligible systematic reviews and meta-analyses, performed data extraction according to predefined forms, and rated the quality of the included systematic reviews and meta-analyses. The quality of the included systematic reviews and meta-analyses will be rated with AMSTAR (A MeaSurement Tool to Assess systematic Reviews) 2. Data will be analyzed descriptively and stratified by AMSTAR 2. Results: We introduced the rationale and design of a systematic overview to summarize and map the chosen IPT outcome domains and the methods of handling these outcomes reported in published systematic reviews and meta-analyses. As of December 2019, we collected 5229 systematic reviews, of which 147 (2.81%) were examined in-depth for eligibility. Topline results are anticipated by September 2020. Conclusions: The results of this study will be published as soon as they are available. Our results will fill a gap in the related literature and will be used to inform the development of a set of recommendations that can be applied in systematic reviews and hopefully serve as a gold standard. © 2020 JMIR Publications. All rights reserved.
33.	Edberg, Anna-Karin, et al. (författare) Exploring existential loneliness among frail older people as a basis for an intervention : protocol for the development phase of the LONE study 2019 Ingår i: JMIR Research Protocols. - : JMIR Publications. - 1929-0748 .- 1929-0748. ; 8:8 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: International research concerning end-of-life issues emphasizes the importance of health care professionals (HCPs) being prepared to deal with existential aspects, like loneliness, in order to provide adequate care. The last phase of life is often related to losses of different kinds, which might trigger feelings of isolation in general and existential loneliness (EL) in particular. There is a large body of research concerning loneliness among older people in general, but little is known about the phenomenon and concept of EL in old age.OBJECTIVE: This study aims to describe the framing, design, and first results of the exploratory phase of an intervention study focusing on EL among older people: the LONE study. This stage of the study corresponds to the development phase, according to the Medical Research Council framework for designing complex interventions.METHODS: The LONE study contains both theoretical and empirical studies concerning: (1) identifying the evidence base; (2) identifying and developing theory through individual and focus group interviews with frail older people, significant others, and HCPs; and (3) modeling process and outcomes for the intervention. This project involves sensitive issues that must be carefully reviewed. The topic in itself concerns a sensitive matter and the study group is vulnerable, therefore, an ethical consciousness will be applied throughout the project.RESULTS: The results so far show that EL means being disconnected from life and implies a feeling of being fundamentally separated from others and the world, whether or not one has family, friends, or other close acquaintances. Although significant others highlighted things such as lack of activities, not participating in a social environment, and giving up on life as aspects of EL, the older people themselves highlighted a sense of meaningless waiting, a longing for a deeper connectedness, and restricted freedom as their origins of EL. The views of HCPs on the origin of EL, the place of care, and their own role differed between contexts.CONCLUSIONS: The studies focusing on identifying the evidence base and developing theory are published. These results will now be used to identify potential intervention components, barriers, and enablers for the implementation of an intervention aimed at supporting HCPs in encountering EL among older people.
34.	Edberg, Anna-Karin, et al. (författare) Exploring existential loneliness among frail older people as a basis for an intervention : protocol for the development phase of the LONE study 2019 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 8:8 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: International research concerning end-of-life issues emphasizes the importance of health care professionals (HCPs) being prepared to deal with existential aspects, like loneliness, in order to provide adequate care. The last phase of life is often related to losses of different kinds, which might trigger feelings of isolation in general and existential loneliness (EL) in particular. There is a large body of research concerning loneliness among older people in general, but little is known about the phenomenon and concept of EL in old age. OBJECTIVE: This study aims to describe the framing, design, and first results of the exploratory phase of an intervention study focusing on EL among older people: the LONE study. This stage of the study corresponds to the development phase, according to the Medical Research Council framework for designing complex interventions. METHODS: The LONE study contains both theoretical and empirical studies concerning: (1) identifying the evidence base; (2) identifying and developing theory through individual and focus group interviews with frail older people, significant others, and HCPs; and (3) modeling process and outcomes for the intervention. This project involves sensitive issues that must be carefully reviewed. The topic in itself concerns a sensitive matter and the study group is vulnerable, therefore, an ethical consciousness will be applied throughout the project. RESULTS: The results so far show that EL means being disconnected from life and implies a feeling of being fundamentally separated from others and the world, whether or not one has family, friends, or other close acquaintances. Although significant others highlighted things such as lack of activities, not participating in a social environment, and giving up on life as aspects of EL, the older people themselves highlighted a sense of meaningless waiting, a longing for a deeper connectedness, and restricted freedom as their origins of EL. The views of HCPs on the origin of EL, the place of care, and theirown role differed between contexts. CONCLUSIONS: The studies focusing on identifying the evidence base and developing theory are published. These results will now be used to identify potential intervention components, barriers, and enablers for the implementation of an intervention aimed at supporting HCPs in encountering EL among older people.
35.	Ekstedt, Mirjam, et al. (författare) Enhanced patient activation in cancer care transitions : protocol for a randomized controlled trial of a tailored eectronic health intervention for men with prostate cancer 2019 Ingår i: JMIR Research Protocols. - : JMIR Publications. - 1929-0748. ; 8:3, s. 1-13 Tidskriftsartikel (refereegranskat)abstract Background: Prostate cancer has increased in incidence worldwide and is the leading cause of cancer death in 24 countries. The most common treatment is radical prostatectomy. However, surgery is associated with postoperative complications such as urinary incontinence and sexual dysfunction, causing decreased quality of life. If survivors are encouraged to be more active in self-care management, the symptom burden may decrease and quality of life may improve. An electronic health (eHealth) intervention based on motivational behavioral theory has been developed for this purpose.Objective: This study aimed to compare the effectiveness of standard care in combination with a tailored eHealth and mobile health self-management support system, electronic Patient Activation in Treatment at Home (ePATH), with standard care of adverse effects of prostate cancer treatment (urinary incontinence and sexual functioning) in men undergoing radical prostatectomy. The secondary aim was to test the effect on patient activation, motivation, overall well-being, and health literacy over time in and between groups.Methods: A pragmatic multicenter, block-randomized controlled trial with 2 study arms, standard care (control) and eHealth-assisted standard care (intervention), for patients undergoing radical prostatectomy. For 80% power, a sample of 242 men will need to be recruited.Results: Recruitment started in January 2018 and is expected to be completed by August 2019. Data collection will be completed in August 2020. The first cross-sectional results from this trial are anticipated to be published in January 2020.Conclusions: With the increasing number of prostate cancer survivors, attention should be paid to rehabilitation, psychosocial care, and support for endurance of self-care to reduce suffering from adverse treatment effects, poor quality of life, and depression because of postoperative complications. This project may increase knowledge of how patients can be supported to feel involved in their care and returning to as normal a life as possible. The anticipated effects of ePATH could improve health outcomes for individuals and facilitate follow-up for health care professionals.
36.	Elf, Marie, 1962-, et al. (författare) Tailoring and Evaluating an Intervention to Support Self-management After Stroke : Protocol for a Multi-case, Mixed Methods Comparison Study 2022 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 11:5 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: Self-management programs are recognized as a valuable approach to supporting people with long-term conditions, such as stroke, in managing their daily lives. Bridges Self-Management (Bridges) focuses on how practitioners interact and support patients' confidence, skills, and knowledge, and it is an example of a complex intervention. Bridges has been developed and used across multiple health care pathways in the United Kingdom and is theoretically informed by social cognition theory and self-efficacy principles. Evidence shows that self-management programs based on the construct of self-efficacy can be effective. There is still much to learn about how health care services or pathways should implement support for self-management in a sustainable way and whether this implementation process is different depending on the context or culture of the team or service provided.OBJECTIVE: The aim of this study is to tailor and evaluate an intervention (Bridges) to support self-management after stroke in a Swedish context.METHODS: We will use a pretest-posttest design with a case study approach to evaluate the feasibility and implementation of self-management support in two stroke settings. This project includes a complex intervention and depends on the actions of individuals, different contexts, and the adaptation of behavior over time. A mixed methods approach was chosen to understand both outcomes and mechanisms of impact. Data collection will comprise outcome measurements and assessment tools as well as qualitative interviews. Data will be collected concurrently and integrated into a mixed methods design.RESULTS: Recruitment and data collection for the first site of the project ran from September 1, 2021, to January 17, 2022. The intervention at the first site was conducted from November 1, 2021, to March 5, 2022. The evaluation will start after the implementation phase. The second site has been recruited, and the baseline data collection will start in spring 2022. The intervention will start in early autumn 2022. Data collection will be completed by the end of 2022.CONCLUSIONS: This study represents a unique, highly relevant, and innovative opportunity to maximize knowledge and minimize practice gaps in rehabilitation stroke care. The study will produce robust data on the intervention and in-depth data on the contextual factors and mechanisms related to the feasibility of the intervention and for whom it is feasible. Bridges has been used in the United Kingdom for more than 10 years, and this study will explore its contextualization and implementation within a Swedish stroke environment. The evaluation will study results at the patient, staff, and organizational levels and provide recommendations for the adoption and refinement of future efforts to support self-management.
37.	Elling, Devy Lysandra, et al. (författare) Effectiveness of Combining Organizational Alcohol Policy and Skills Training for Managers to Reduce Hazardous Alcohol Consumption in Swedish Workplaces : Study Protocol for a Cluster Randomized Study 2020 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 9:8 Tidskriftsartikel (refereegranskat)abstract Background: High alcohol consumption poses risks to individual health and society. Previous alcohol interventions have mainly focused on high-risk consumers or young adults in school-based settings. Since the majority of the adult population is in the workforce, the workplace can be considered a favorable arena for implementing interventions.Objective: This protocol describes a project aimed at increasing knowledge of the effectiveness of combining the implementation of an organizational alcohol policy with skills training for managers as a workplace alcohol prevention program, by evaluating the intervention and exploring managers’ perceptions of the intervention.Methods: Organizations with at least 100 employees were invited to take part in the project. A total of 11 organizations (744 managers and 11,761 employees) were included in the project. Data are collected through self-administered online surveys at baseline, 12 months, and 24 months. The primary outcome is managers’ inclination to initiate an early alcohol intervention (eg, by initiating a dialogue) when concern regarding employees’ hazardous alcohol consumption arises. The secondary outcomes of interest are managers’ and employees’ organizational alcohol policy knowledge and changes in alcohol consumption, as measured using the Alcohol Use Disorder Identification Test (AUDIT) score. A linear mixed-model framework will be used to model variability on different levels. Primary analysis will follow an intention-to-treat approach. Additionally, managers’ responses from semistructured interviews will be analyzed using thematic analysis to explore managers’ experiences regarding the prevention program.Results: This study is ongoing. The overall study start was on January 2018, and the study is planned to end in December 2020. Baseline and 12-month follow-up measurements have been collected.Conclusions: This project is designed to evaluate the effectiveness of an alcohol prevention program regarding higher inclination to initiate early alcohol interventions after policy implementation and skills training among managers, compared to the usual practices in the workplace. The results from this study can contribute to increased knowledge about alcohol interventions and future prevention programs in the workplace.Trial Registration: ISRCTN17250048; http://www.isrctn.com/ISRCTN17250048International Registered Report Identifier (IRRID): DERR1-10.2196/17145
38.	Ellingsen, MM, et al. (författare) Effects of Acute Exercise on Drug Craving, Self-Esteem, Mood, and Affect in Adults with Polysubstance Use Disorder: Protocol for a Multicenter Randomized Controlled Trial 2020 Ingår i: JMIR research protocols. - 1929-0748. ; 229:10, s. e18553- Tidskriftsartikel (refereegranskat)
39.	English, Andrew, et al. (författare) Genomic, Proteomic, and Phenotypic Biomarkers of COVID-19 Severity: Protocol for a Retrospective Observational Study 2024 Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 13 Tidskriftsartikel (refereegranskat)abstract Background: Health organizations and countries around the world have found it difficult to control the spread of COVID-19. To minimize the future impact on the UK National Health Service and improve patient care, there is a pressing need to identify individuals who are at a higher risk of being hospitalized because of severe COVID-19. Early targeted work was successful in identifying angiotensin-converting enzyme -2 receptors and type II transmembrane serine protease dependency as drivers of severe infection. Although a targeted approach highlights key pathways, a multiomics approach will provide a clearer and more comprehensive picture of severe COVID-19 etiology and progression. Objective: The COVID-19 Response Study aims to carry out an integrated multiomics analysis to identify biomarkers in blood and saliva that could contribute to host susceptibility to SARS-CoV-2 and the development of severe COVID-19. Methods: The COVID-19 Response Study aims to recruit 1000 people who recovered from SARS-CoV-2 infection in both community and hospital settings on the island of Ireland. This protocol describes the retrospective observational study component carried out in Northern Ireland (NI; Cohort A); the Republic of Ireland cohort will be described separately. For all NI participants (n=519), SARS-CoV-2 infection has been confirmed by reverse transcription -quantitative polymerase chain reaction. A prospective Cohort B of 40 patients is also being followed up at 1, 3, 6, and 12 months postinfection to assess longitudinal symptom frequency and immune response. Data will be sourced from whole blood, saliva samples, and clinical data from the electronic care records, the general health questionnaire, and a 12 -item general health questionnaire mental health survey. Saliva and blood samples were processed to extract DNA and RNA before whole-genome sequencing, RNA sequencing, DNA methylation analysis, microbiome analysis, 16S ribosomal RNA gene sequencing, and proteomic analysis were performed on the plasma. Multiomics data will be combined with clinical data to produce sensitive and specific prognostic models for severity risk. Results: An initial demographic and clinical profile of the NI Cohort A has been completed. A total of 249 hospitalized patients and 270 nonhospitalized patients were recruited, of whom 184 (64.3%) were female, and the mean age was 45.4 (SD 13) years. High levels of comorbidity were evident in the hospitalized cohort, with cardiovascular disease and metabolic and respiratory disorders being the most significant (P<.001), grouped according to the International Classification of Diseases 10 codes. Conclusions: This study will provide a comprehensive opportunity to study the mechanisms of COVID-19 severity in recontactable participants.
40.	Escalé-Besa, A., et al. (författare) Using Artificial Intelligence as a Diagnostic Decision Support Tool in Skin Disease: Protocol for an Observational Prospective Cohort Study 2022 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 11:8 Tidskriftsartikel (refereegranskat)abstract Background: Dermatological conditions are a relevant health problem. Each person has an average of 1.6 skin diseases per year, and consultations for skin pathology represent 20% of the total annual visits to primary care and around 35% are referred to a dermatology specialist. Machine learning (ML) models can be a good tool to help primary care professionals, as it can analyze and optimize complex sets of data. In addition, ML models are increasingly being applied to dermatology as a diagnostic decision support tool using image analysis, especially for skin cancer detection and classification. Objective: This study aims to perform a prospective validation of an image analysis ML model as a diagnostic decision support tool for the diagnosis of dermatological conditions. Methods: In this prospective study, 100 consecutive patients who visit a participant general practitioner (GP) with a skin problem in central Catalonia were recruited. Data collection was planned to last 7 months. Anonymized pictures of skin diseases were taken and introduced to the ML model interface (capable of screening for 44 different skin diseases), which returned the top 5 diagnoses by probability. The same image was also sent as a teledermatology consultation following the current stablished workflow. The GP, ML model, and dermatologist’s assessments will be compared to calculate the precision, sensitivity, specificity, and accuracy of the ML model. The results will be represented globally and individually for each skin disease class using a confusion matrix and one-versus-all methodology. The time taken to make the diagnosis will also be taken into consideration. Results: Patient recruitment began in June 2021 and lasted for 5 months. Currently, all patients have been recruited and the images have been shown to the GPs and dermatologists. The analysis of the results has already started. Conclusions: This study will provide information about ML models’ effectiveness and limitations. External testing is essential for regulating these diagnostic systems to deploy ML models in a primary care practice setting. © Anna Escalé-Besa, Aïna Fuster-Casanovas, Alexander Börve, Oriol Yélamos, Xavier Fustà-Novell, Mireia Esquius Rafat, Francesc X Marin-Gomez, Josep Vidal-Alaball.
41.	Etminani, Kobra, 1984-, et al. (författare) Improving Medication Adherence Through Adaptive Digital Interventions (iMedA) in Patients With Hypertension : Protocol for an Interrupted Time Series Study 2021 Ingår i: JMIR Research Protocols. - Toronto : JMIR. - 1929-0748. ; 10:5 Tidskriftsartikel (refereegranskat)abstract Background: There is a strong need to improve medication adherence (MA) for individuals with hypertension in order to reduce long-term hospitalization costs. We believe this can be achieved through an artificial intelligence agent that helps the patient in understanding key individual adherence risk factors and designing an appropriate intervention plan. The incidence of hypertension in Sweden is estimated at approximately 27%. Although blood pressure control has increased in Sweden, barely half of the treated patients achieved adequate blood pressure levels. It is a major risk factor for coronary heart disease and stroke as well as heart failure. MA is a key factor for good clinical outcomes in persons with hypertension.Objective: The overall aim of this study is to design, develop, test, and evaluate an adaptive digital intervention called iMedA, delivered via a mobile app to improve MA, self-care management, and blood pressure control for persons with hypertension.Methods: The study design is an interrupted time series. We will collect data on a daily basis, 14 days before, during 6 months of delivering digital interventions through the mobile app, and 14 days after. The effect will be analyzed using segmented regression analysis. The participants will be recruited in Region Halland, Sweden. The design of the digital interventions follows the just-in-time adaptive intervention framework. The primary (distal) outcome is MA, and the secondary outcome is blood pressure. The design of the digital intervention is developed based on a needs assessment process including a systematic review, focus group interviews, and a pilot study, before conducting the longitudinal interrupted time series study.Results: The focus groups of persons with hypertension have been conducted to perform the needs assessment in a Swedish context. The design and development of digital interventions are in progress, and the interventions are planned to be ready in November 2020. Then, the 2-week pilot study for usability evaluation will start, and the interrupted time series study, which we plan to start in February 2021, will follow it.Conclusions: We hypothesize that iMedA will improve medication adherence and self-care management. This study could illustrate how self-care management tools can be an additional (digital) treatment support to a clinical one without increasing burden on health care staff. © Kobra Etminani, Carina Göransson, Alexander Galozy, Margaretha Norell Pejner, Sławomir Nowaczyk.
42.	Foley, K, et al. (författare) Massive Open Online Courses (MOOC) Evaluation Methods: Protocol for a Systematic Review 2019 Ingår i: JMIR research protocols. - : JMIR Publications Inc.. - 1929-0748. ; 8:3, s. e12087- Tidskriftsartikel (refereegranskat)
43.	Forsström, David, et al. (författare) Internet-Delivered Cognitive Behavioral Therapy for Problematic Alcohol Use in a Workplace Setting : Protocol for Quantitative and Qualitative Evaluation of Feasibility and Outcomes 2020 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 9:7 Tidskriftsartikel (refereegranskat)abstract Background: Internet-based cognitive behavioral therapy (ICBT) for mental health issues has been successfully implemented in routine health care settings, and research indicates that ICBT can also be applied to decrease problematic alcohol use in workplace settings. However, studies investigating the feasibility of implementing ICBT in a workplace setting have been lacking.Objective: The current study aims to investigate the feasibility of delivering ICBT for problematic alcohol use within an employee assistance program (EAP).Methods: The study has a quantitative naturalistic design, quantitively comparing ICBT and face-to-face treatment, and allowing for qualitative interviews with employees and employers. Recruitment of participants follows a five-session in-person psychological assessment at an EAP regarding an employee's presumed problematic alcohol consumption. All assessed employees referred to ICBT or face-to-face treatment will be offered participation in the study. Interviews will be held with employees and their employer representatives following ICBT to elucidate both stakeholders' experience and perception of ICBT and its context. Outcome comparisons between ICBT and face-to-face treatment will be assessed quantitatively using a Reliable Change Index and analysis of variance. Thematic analysis and Grounded Theory will be used to analyze the interview material.Results: The study is set to begin in April 2020 and to end in September 2021. The aim is to recruit up to 150 participants to the quantitative part of the study and 45 participants (15 employees and 30 employer representatives) to the qualitative part of the study.Conclusions: The current study will provide knowledge that is lacking and urgently needed on how to implement ICBT for problematic alcohol use in a workplace setting.
44.	Fuhrimann, Samuel, et al. (författare) Exposure to pesticides and health effects on farm owners and workers from conventional and organic agricultural farms in Costa Rica : Protocol for a cross-sectional study 2019 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 8:1 Tidskriftsartikel (refereegranskat)abstract Background: Pesticide use is increasing in low- and middle-income countries (LMICs) including Costa Rica. This increase poses health risks to farm owners, farm workers, and communities living near agricultural farms. Objective: We aimed to examine the health effects associated with occupational pesticide exposure in farm owners and workers from conventional and organic smallholder farms in Costa Rica. Methods: We conducted a cross-sectional study involving 300 owners and workers from organic and conventional horticultural smallholder farms in Zarcero County, Costa Rica. During the baseline study visit, we administered a structured, tablet-based questionnaire to collect data on sociodemographic characteristics, pesticide exposure, and health conditions (eg, respiratory and allergic outcomes and acute pesticide intoxication symptoms) and administered a neurobehavioral test battery (eg, Finger Tapping Test and Purdue Pegboard); we measured blood pressure, anthropometry (height, weight, and waist circumference), and erythrocytic acetylcholinesterase activity and also collected urine samples. In addition, a functional neuroimaging assessment using near-infrared spectroscopy was conducted with a subset of 50 study participants. During the follow-up study visit (~2-4 weeks after the baseline), we administered participants a short questionnaire on recent pesticide exposure and farming practices and collected hair, toenail, and urine samples. Urine samples will be analyzed for various pesticide metabolites, whereas toenails and hair will be analyzed for manganese (Mn), a biomarker of exposure to Mn-containing fungicides. Self-reported pesticide exposure data will be used to develop exposure intensity scores using an exposure algorithm. Furthermore, exposure-outcome associations will be examined using linear and logistic mixed-effects regression models. Results: Fieldwork for our study was conducted between May 2016 and August 2016. In total, 113 farm owners and 187 workers from 9 organic and 83 conventional horticultural smallholder farms were enrolled. Data analyses are ongoing and expected to be published between 2019 and 2020. Conclusions: This study is one of the first to examine differences in health effects due to pesticide exposure between farm owners and workers from organic and conventional smallholder farms in an LMIC. We expect that this study will provide critical data on farming practices, exposure pathways, and how occupational exposure to pesticides may affect farm owners and workers’ health. Finally, we hope that this study will allow us to identify strategies to reduce pesticide exposure in farm owners and workers and will potentially lay the groundwork for a future longitudinal study of health outcomes in farm owners and workers exposed to pesticides.
45.	Galanti, Maria Rosaria, et al. (författare) Tobacco-Free Duo Adult-Child Contract for Prevention of Tobacco Use Among Adolescents and Parents : Protocol for a Mixed-Design Evaluation 2020 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 9:10 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: Universal tobacco-prevention programs targeting youths usually involve significant adults, who are assumed to be important social influences. Commitment not to use tobacco, or to quit use, as a formal contract between an adolescent and a significant adult is a preventive model that has not been widely practiced or explored and has been formally evaluated even less. In this paper, we present the rationale and protocol for the evaluation of the Swedish Tobacco-free Duo program, a multicomponent school-based program the core of which rests on a formal agreement between an adolescent and an adult. The adolescent's commitment mainly concerns avoiding the onset of any tobacco use while the adult commits to support the adolescent in staying tobacco free, being a role model by not using tobacco themselves.OBJECTIVE: To assess (1) whether Tobacco-free Duo is superior to an education-only program in preventing smoking onset among adolescents and promoting cessation among their parents, (2) whether exposure to core components (adult-child agreement) entails more positive effects than exposure to other components, (3) the impact of the program on whole school tobacco use, (4) potential negative side effects, and (5) school-level factors related to fidelity of the program's implementation.METHODS: A mixed-design approach was developed. First, a cluster randomized controlled trial was designed with schools randomly assigned to either the comprehensive multicomponent program or its educational component only. Primary outcome at the adolescent level was identified as not having tried tobacco during the 3-year junior high school compulsory grades (12-15 years of age). An intention-to-treat cohort-wise approach and an as-treated approach complemented with a whole school repeated cross-sectional approach was devised as analytical methods of the trial data. Second, an observational study was added in order to compare smoking incidence in the schools participating in the experiment with that of a convenience sample of schools that were not part of the experimental study. Diverse secondary outcomes at both adolescent and adult levels were also included.RESULTS: The study was approved by the Umeå Regional Ethics Review Board (registration number 2017/255-31) in 2017. Recruitment of schools started in fall 2017 and continued until June 2018. In total, 43 schools were recruited to the experimental study, and 16 schools were recruited to the observational study. Data collection started in the fall 2018, is ongoing, and is planned to be finished in spring 2021.CONCLUSIONS: Methodological, ethical, and practical implications of the evaluation protocol were discussed, especially the advantage of combining several sources of data, to triangulate the study questions. The results of these studies will help revise the agenda of this program as well as those of similar programs.TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 52858080; https://doi.org/10.1186/ISRCTN52858080.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21100.
46.	Gaudenzi, Giulia, et al. (författare) Point-of-Care Approaches for Meningitis Diagnosis in a Low-Resource Setting (Southwestern Uganda) : Observational Cohort Study Protocol of the "PI-POC" Trial 2020 Ingår i: Journal of Medical Internet Research. - : JMIR Publications Inc.. - 1438-8871. ; 22:11 Tidskriftsartikel (refereegranskat)abstract Background: A timely differential diagnostic is essential to identify the etiology of central nervous system (CNS) infections in children, in order to facilitate targeted treatment, manage patients, and improve clinical outcome. Objective: The Pediatric Infection-Point-of-Care (PI-POC) trial is investigating novel methods to improve and strengthen the differential diagnostics of suspected childhood CNS infections in low-income health systems such as those in Southwestern Uganda. This will be achieved by evaluating (1) a novel DNA-based diagnostic assay for CNS infections, (2) a commercially available multiplex PCR-based meningitis/encephalitis (ME) panel for clinical use in a facility-limited laboratory setting, (3) proteomics profiling of blood from children with severe CNS infection as compared to outpatient controls with fever yet not severely ill, and (4) Myxovirus resistance protein A (MxA) as a biomarker in blood for viral CNS infection. Further changes in the etiology of childhood CNS infections after the introduction of the pneumococcal conjugate vaccine against Streptococcus pneumoniae will be investigated. In addition, the carriage and invasive rate of Neisseria meningitidis will be recorded and serotyped, and the expression of its major virulence factor (polysaccharide capsule) will be investigated. Methods: The PI-POC trial is a prospective observational study of children including newborns up to 12 years of age with clinical features of CNS infection, and age-/sex-matched outpatient controls with fever yet not severely ill. Participants are recruited at 2 Pediatric clinics in Mbarara, Uganda. Cerebrospinal fluid (for cases only), blood, and nasopharyngeal (NP) swabs (for both cases and controls) sampled at both clinics are analyzed at the Epicentre Research Laboratory through gold-standard methods for CNS infection diagnosis (microscopy, biochemistry, and culture) and a commercially available ME panel for multiplex PCR analyses of the cerebrospinal fluid. An additional blood sample from cases is collected on day 3 after admission. After initial clinical analyses in Mbarara, samples will be transported to Stockholm, Sweden for (1) validation analyses of a novel nucleic acid-based POC test, (2) biomarker research, and (3) serotyping and molecular characterization of S. pneumoniae and N. meningitidis. Results: A pilot study was performed from January to April 2019. The PI-POC trial enrollment of patients begun in April 2019 and will continue until September 2020, to include up to 300 cases and controls. Preliminary results from the PI-POC study are expected by the end of 2020. Conclusions: The findings from the PI-POC study can potentially facilitate rapid etiological diagnosis of CNS infections in low-resource settings and allow for novel methods for determination of the severity of CNS infection in such environment.
47.	Goedecke, Julia H., et al. (författare) An Exercise Intervention to Unravel the Mechanisms Underlying Insulin Resistance in a Cohort of Black South African Women : Protocol for a Randomized Controlled Trial and Baseline Characteristics of Participants 2018 Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 7:4 Tidskriftsartikel (refereegranskat)abstract Background: The pathogenesis of type 2 diabetes (T2D) in black African women is complex and differs from that in their white counterparts. However, earlier studies have been cross-sectional and provide little insight into the causal pathways. Exercise training is consistently used as a model to examine the mechanisms underlying insulin resistance and risk for T2D.Objective: The objective of the study was to examine the mechanisms underlying the changes in insulin sensitivity and secretion in response to a 12-week exercise intervention in obese black South African (SA) women.Methods: A total of 45 obese (body mass index, BMI: 30-40 kg/m2) black SA women were randomized into a control (n=22) or experimental (exercise; n=23) group. The exercise group completed 12 weeks of supervised combined aerobic and resistance training (40-60 min, 4 days/week), while the control group maintained their typical physical activity patterns, and both groups were requested not to change their dietary patterns. Before and following the 12-week intervention period, insulin sensitivity and secretion (frequently sampled intravenous glucose tolerance test) and its primary and secondary determinants were measured. Dietary intake, sleep quality and quantity, physical activity, and sedentary behaviors were measured every 4 weeks.Results: The final sample included 20 exercise and 15 control participants. Baseline sociodemographics, cardiorespiratory fitness, anthropometry, cardiometabolic risk factors, physical activity, and diet did not differ between the groups (P>.05).Conclusions: The study describes a research protocol for an exercise intervention to understand the mechanisms underlying insulin sensitivity and secretion in obese black SA women and aims to identify causal pathways underlying the high prevalence of insulin resistance and risk for T2D in black SA women, targeting specific areas for therapeutic intervention.
48.	Gomez, A, et al. (författare) Near-Infrared Cerebrovascular Reactivity for Monitoring Cerebral Autoregulation and Predicting Outcomes in Moderate to Severe Traumatic Brain Injury: Proposal for a Pilot Observational Study 2020 Ingår i: JMIR research protocols. - : JMIR Publications Inc.. - 1929-0748. ; 9:8, s. e18740- Tidskriftsartikel (refereegranskat)abstract Impaired cerebrovascular reactivity after traumatic brain injury (TBI) in adults is emerging as an important prognostic factor, with strong independent association with 6-month outcomes. To date, it is unknown if impaired cerebrovascular reactivity during the acute phase is associated with ongoing impaired continuously measured cerebrovascular reactivity in the long-term, and if such measures are associated with clinical phenotype at those points in time.ObjectiveWe describe a prospective pilot study to assess the use of near-infrared spectroscopy (NIRS) to derive continuous measures of cerebrovascular reactivity during the acute and long-term phases of TBI in adults.MethodsOver 2 years, we will recruit up to 80 adults with moderate/severe TBI admitted to the intensive care unit (ICU) with invasive intracranial pressure (ICP) monitoring. These patients will undergo high-frequency data capture of ICP, arterial blood pressure (ABP), and NIRS for the first 5 days of care. Patients will then have 30 minutes of noninvasive NIRS and ABP monitoring in the clinic at 3, 6, and 12 months post-injury. Outcomes will be assessed via the Glasgow Outcome Scale and Short Form-12 questionnaires. Various relationships between NIRS and ICP-derived cerebrovascular reactivity metrics and associated outcomes will be assessed using biomedical signal processing techniques and both multivariate and time-series statistical methodologies.ResultsStudy recruitment began at the end of February 2020, with data collection ongoing and three patients enrolled at the time of writing. The expected duration of data collection will be from February 2020 to January 2022, as per our local research ethics board approval (B2018:103). Support for this work has been obtained through the National Institutes of Health (NIH) through the National Institute of Neurological Disorders and Stroke (NINDS) (R03NS114335), funded in January 2020.ConclusionsWith the application of NIRS technology for monitoring of patients with TBI, we expect to be able to outline core relationships between noninvasively measured aspects of cerebral physiology and invasive measures, as well as patient outcomes. Documenting these relationships carries the potential to revolutionize the way we monitor patients with TBI, moving to more noninvasive techniques.International Registered Report Identifier (IRRID)DERR1-10.2196/18740
49.	Granbom, Marianne, et al. (författare) Older Adults Living in Disadvantaged Areas : Protocol for a Mixed Methods Baseline Study on Homes, Quality of Life, and Participation in Transitioning Neighborhoods 2022 Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 11:10, s. 1-10 Tidskriftsartikel (refereegranskat)abstract BACKGROUND: Swedish policy states that older adults should be able to age safely with continued independence and lead active lives. However, this plays out differently in different Swedish municipalities depending upon degree of demographic change, globalization, and urbanization. Internationally, older adults living in disadvantaged areas have worse physical and mental health, activity restrictions, and reduced life expectancy. In Sweden, research on how disadvantaged areas impact older adults' quality of life is virtually nonexistent. We argue that disadvantaged areas exist in both urban and rural contexts.OBJECTIVE: We aimed to investigate how older adults' homes and neighborhoods influence their community participation, quality of life, identity, and belonging in urban and rural disadvantaged areas in Sweden, and how these person-context dynamics are experienced by older adults in transitioning neighborhoods.METHODS: The study has a mixed methods design and includes 3 phases. Adults 65 years and older living in certain urban and rural disadvantaged areas in the south of Sweden will be included. Phase 1 is an interview study in which qualitative data are collected on neighborhood attachment, identity, and belonging through semistructured interviews and photo-elicitation interviews with 40 subjects. A variety of qualitative data analysis procedures are used. In phase 2, a survey study will be conducted to explore associations between observable and self-rated aspects of housing and neighborhood (physical, social, and emotional), participation, and quality of life; 400 subjects will be recruited and added to the 40 phase-1 subjects for a total of 440. The survey will include standardized measures and study-specific questions. Survey data will be analyzed with mainstream statistical analyses and structural equation modeling to understand the interactions between quality of life, home and neighborhood factors, and sociodemographic factors. In phase 3, the integration study, survey data from the 40 participants who participated in both data collections will be analyzed together with qualitative data with a mixed methods analysis approach.RESULTS: As of the submission of this protocol (August 2022), recruitment for the interview study is complete (N=39), and 267 participants have been recruited and have completed data collection in the survey study. We expect recruitment and data collection to be finalized by December 2022.CONCLUSIONS: With an increasing proportion of older adults, an increasing number of disadvantaged areas, and an increasing dependency ratio in more than 50% of Swedish municipalities, these municipalities are transforming and becoming increasingly segregated. This study will add unique knowledge on what it is like to be older in a disadvantaged area and deepen knowledge on housing and health dynamics in later life. Further, the design of the current study will allow future follow-up studies to facilitate longitudinal analysis (if funding is granted) on aging in a transforming societal context.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41255.
50.	Greenhalgh, Trisha, et al. (författare) The NASSS-CAT Tools for Understanding, Guiding, Monitoring, and Researching Technology Implementation Projects in Health and Social Care : Protocol for an Evaluation Study in Real-World Settings 2020 Ingår i: JMIR Research Protocols. - : JMIR Publications. - 1929-0748. ; 9:5 Tidskriftsartikel (refereegranskat)abstract Background: Projects to implement health care and social care innovations involving technologies are typically ambitious and complex. Many projects fail. Greenhalgh et al’s nonadoption, abandonment, scale-up, spread, and sustainability (NASSS) framework was developed to analyze the varied outcomes of such projects.Objective: We sought to extend the NASSS framework to produce practical tools for understanding, guiding, monitoring, and researching technology projects in health care or social care settings.Methods: Building on NASSS and a complexity assessment tool (CAT), the NASSS-CAT tools were developed (in various formats) in seven co-design workshops involving 50 stakeholders (industry executives, technical designers, policymakers, managers, clinicians, and patients). Using action research, they were and are being tested prospectively on a sample of case studies selected for variety in conditions, technologies, settings, scope and scale, policy context, and project goals.Results: The co-design process resulted in four tools, available as free downloads. NASSS-CAT SHORT is a taster to introduce the instrument and gauge interest. NASSS-CAT LONG is intended to support reflection, due diligence, and preliminary planning. It maps complexity through stakeholder discussion across six domains, using free-text open questions (designed to generate a rich narrative and surface uncertainties and interdependencies) and a closed-question checklist; this version includes an action planning section. NASSS-CAT PROJECT is a 35-item instrument for monitoring how subjective complexity in a technology implementation project changes over time. NASSS-CAT INTERVIEW is a set of prompts for conducting semistructured research or evaluation interviews. Preliminary data from empirical case studies suggest that the NASSS-CAT tools can potentially identify, but cannot always help reconcile, contradictions and conflicts that block projects’ progress.Conclusions: The NASSS-CAT tools are a useful addition to existing implementation tools and frameworks. Further support of the implementation projects is ongoing. We are currently producing digital versions of the tools, and plan (subject to further funding) to establish an online community of practice for people interested in using and improving the tools, and hold workshops for building cross-project collaborations. International Registered Report Identifier (IRRID): DERR1-10.2196/16861

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