| 1. |
- Alriksson-Schmidt, Ann I., et al.
(författare)
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The natural history of spina bifida in children pilot project : Research protocol
- 2013
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Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 2:1
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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.
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| 2. |
- Alriksson-Schmidt, Ann, et al.
(författare)
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Improving the Health of Individuals With Cerebral Palsy: Protocol for the Multidisciplinary Research Program MOVING ON WITH CP
- 2019
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Ingår i: Jmir Research Protocols. - Toronto, Canada : JMIR Publications Inc.. - 1929-0748. ; 8:10
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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.
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| 3. |
- Anderberg, Peter, et al.
(författare)
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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
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Ingår i: Journal of Medical Internet Research. - : Journal of Medical Internet Research. - 1438-8871. ; 21:10
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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.
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| 4. |
- Anderberg, Peter, et al.
(författare)
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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
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Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 8:6
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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.
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| 5. |
- Bachnick, Stefanie, et al.
(författare)
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TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) Project : Protocol for an International Longitudinal Multicenter Study
- 2024
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Ingår i: JMIR Research Protocols. - 1929-0748. ; 13
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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.
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| 6. |
- Baker, K., et al.
(författare)
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Automated respiratory rate counter to assess children for symptoms of pneumonia: Protocol for cross-sectional usability and acceptability studies in Ethiopia and Nepal
- 2020
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Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 9:3
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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.
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| 7. |
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| 8. |
- Baker, K., et al.
(författare)
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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
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Ingår i: JMIR Res Protoc. - : JMIR Publications Inc.. - 1929-0748. ; 7:10
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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.
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| 9. |
- Barbabella, Francesco, et al.
(författare)
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A web-based psychosocial intervention for family caregivers of older people : results from a mixed-methods study in three European countries
- 2016
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Ingår i: JMIR Research Protocols. - : JMIR Publications. - 1929-0748. ; 5:4, s. 1-16
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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).
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| 10. |
- Belfrage, Emma, et al.
(författare)
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Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome (BIO-MUSE) : Protocol for a Translational Study
- 2024
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Ingår i: JMIR Research Protocols. - 1929-0748. ; 13
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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.
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| 11. |
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| 12. |
- Bendtsen, Marcus, et al.
(författare)
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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
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Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 9:12
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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.
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| 13. |
- Bendtsen, Marcus, 1982-, et al.
(författare)
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Mobile Phone-Based Smoking-Cessation Intervention for Patients Undergoing Elective Surgery : Protocol for a Randomized Controlled Trial
- 2019
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Ingår i: JMIR Research Protocols. - Toronto, Canada : J M I R Publications, Inc.. - 1929-0748. ; 8:3
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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.
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| 14. |
- Bendtsen, Marcus, 1982-, et al.
(författare)
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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
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Ingår i: JMIR Research Protocols. - Toronto, Canada : J M I R Publications, Inc.. - 1929-0748. ; 8:4
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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.
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| 15. |
- Bendtsen, Marcus, 1982-
(författare)
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Text Messaging Interventions for Reducing Alcohol Consumption Among Harmful and Hazardous Drinkers : Protocol for a Systematic Review and Meta-Analysis
- 2019
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Ingår i: JMIR Research Protocols. - Toronto, Canada : J M I R Publications, Inc.. - 1929-0748. ; 8:4
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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.
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| 16. |
- Bendtsen, Marcus, et al.
(författare)
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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
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Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 9:11
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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.
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| 17. |
- Bendtsen, Marcus, 1982-, et al.
(författare)
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The Mobile Health Multiple Lifestyle Behavior Interventions Across the Lifespan (MoBILE) Research Program : Protocol for Development, Evaluation, and Implementation
- 2020
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Ingår i: JMIR Research Protocols. - Toronto, Canada : JMIR Publications Inc. - 1929-0748. ; 9:4
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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.
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| 18. |
- Berbyuk Lindström, Nataliya, 1978, et al.
(författare)
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Person- and Family-Centeredness in Ethiopian Cancer Care: Improving Communication, Ethics, Decision Making and Health
- 2020
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Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 9:5
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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.
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| 19. |
- Bergman Nordgren, Lise, 1983-, et al.
(författare)
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Role of the Working Alliance on Treatment Outcome in Tailored Internet-Based Cognitive Behavioural Therapy for Anxiety Disorders : Randomized Controlled Pilot Trial
- 2013
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Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 2:1
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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.
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| 20. |
- Berman, Anne H., et al.
(författare)
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Mobile phone apps for university students with hazardous alcohol use : study protocol for two consecutive randomized controlled trials
- 2015
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Ingår i: JMIR Research Protocols. - : JMIR Publications. - 1929-0748. ; 4:4
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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.
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| 21. |
- Bjerkan, Jorunn, et al.
(författare)
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Citizen-Patient Involvement in the Development of mHealth Technology : Protocol for a Systematic Scoping Review
- 2020
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Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS. - 1929-0748. ; 9:8
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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.
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| 22. |
- Bonn, Stephanie Erika, et al.
(författare)
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A Validation Study of the Web-Based Physical Activity Questionnaire Active-Q Against the GENEA Accelerometer
- 2015
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Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 4:3
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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.
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| 23. |
- Bonn, Stephanie Erika, et al.
(författare)
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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
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Ingår i: JMIR Research Protocols. - : JMIR PUBLICATIONS, INC. - 1929-0748. ; 9:8
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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.
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| 24. |
- Brennan, M. T., et al.
(författare)
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Impact of Oral Side Effects from Conditioning Therapy Before Hematopoietic Stem Cell Transplantation: Protocol for a Multicenter Study
- 2018
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Ingår i: Jmir Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 7:4
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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.
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| 25. |
- Calaminus, Gabriele, et al.
(författare)
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Quality of life of patients with osteosarcoma in the european american osteosarcoma study-1 (EURAMOS-1) : Development and implementation of a questionnaire substudy
- 2019
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Ingår i: JMIR Research Protocols. - : JMIR Publications Inc.. - 1929-0748. ; 8:9
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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.
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