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During the last decade Sweden has invested in a national infrastructure for collection of structured clinical data in the form of healthcare registries (in Sweden known as Kvalitetsregister). These data can be combined with other public data using the national personal identifiers that are issued to Swedish citizens. The healthcare registries have an almost complete coverage of Swedish healthcare, and a large network of clinicians is involved in the quality assurance and continuous improvement of healthcare using these registries. Uppsala Clinical Research Center (UCR) has been a technology provider of large-scale national registries and has a strong background in clinical trial management. This effort combines the areas of healthcare registries and clinical trials into a novel way of performing clinical trials to be able to: 1) run clinical trials as an integrated part of normal clinic workflow; and 2) leverage the nationwide network of outcome reporting. This strategy was shown to be successful in the TASTE (Thrombus Aspiration in Myocardial Infarction) study. When TASTE had been published, the New England Journal of Medicine wrote a perspective on the study calling it 'The randomized registry trial—the next disruptive technology in clinical research?' Since then several studies have been conducted in this way with great success. UCR has been appointed, by Clinical Studies Sweden and the Swedish Research Council, to develop the Swedish national guidelines for registry-based randomized clinical trials in order to ensure the possibility for more organizations to run this kind of study. This paper describes key concepts of register-based randomized clinical trials and the development of Swedish national guidelines. [ABSTRACT FROM AUTHOR]

Background: The context is highly relevant to the implementation of new health-related programs and is an implicit or explicit part of the major implementation models in the literature. The Resilience Curriculum (RESCUR) program was developed to foster the psychosocial development of children in early and primary education. RESCUR seeks specifically to decrease children's vulnerability. It aims to promote the emotional and social learning of children who may be at risk of leaving school pre-maturely, social exclusion and mental-health problems. The program is taught using a teachers' manual to support consistency of delivery, a parents' guide, and a resource package. This study aimed to examine the scaling-out of RESCUR to social services, and specifically to test if implementation differs between the school and social services sectors. Methods: RESCUR was implemented in schools and social services in Sweden 2017–2019. Data were collected via group leaders' self-reports and observation protocols for 3 months after implementation started. There were 34 self-reports from schools, and 12 from the social services sector; 30 observation protocols were collected from schools, and 10 from social services. We examined whether there were differences in implementation outcomes (in, for example, dosage, duration, fidelity, adaptation, quality of delivery) between the two delivery systems. Descriptive statistics were prepared and non-parametric tests of significance conducted to compare implementation-related factors across the two settings. Results: Analyses of both the observation protocols and group leaders' self-reports revealed that RESCUR was well-implemented in both schools and social services. The results showed a few significant differences in the outcomes of implementation between the sectors. First, regarding observations, school staff more often adapted the pace of RESCUR lessons to ensure that the children could understand than did social services staff (p < 0.01). Second, social services staff demonstrated greater interest in students and sensitivity to the needs of individual students than did school staff (p = 0.02). Regarding self-reports, social services staff reported having delivered more (p = 0.4) and longer (p < 0.01) lessons than did school staff. Second, school staff reported greater fidelity to (p = 0.02) and less adaptation of (p < 0.01) the intervention than did social services staff. Both observations and self-reports, however, indicated a high fidelity of implementation. Conclusions: Overall, the findings suggest that the resilience program, designed for delivery in schools, can be scaled-out to social services with its implementation outcomes retained. Further research is needed to test the effectiveness of the program regarding child health-related outcomes. Clinical Trial Registration: National Institute of Health, ClinicalTrials.gov, identifier: NCT03655418. Registered August 31, 2018. [ABSTRACT FROM AUTHOR]

Background: There is a lack of firm knowledge regarding sexual problems and fertility-related distress in young adults following a diagnosis with cancer. Establishing such understanding is essential to identify patients in need of specific support and to develop cancer care accordingly. This study protocol describes the Fex-Can Cohort study, a population-based prospective cohort study investigating sexual dysfunction and fertility-related distress in young adults diagnosed with cancer in Sweden. The primary objective of the study is to determine the prevalence and predictors of sexual dysfunction and fertility-related distress following a cancer diagnosis in young adulthood compared to prevalence rates for the general population. Further aims are to investigate the trajectories of these issues over time, the co-existence between sexual dysfunction and fertility-related distress, and the relation between these issues and body image, anxiety and depression, health-related quality of life, self-efficacy related to sexuality and fertility, and fertility-related knowledge.Methods: Participants in the Fex-Can Cohort will be identified via the Swedish National Quality Registries for Brain Tumors, Breast Cancer, Gynecological Oncology, Lymphoma, and Testicular Cancer. All patients diagnosed at the ages of 18-39, during a period of 18 months, will be invited to participate. Established instruments will be used to measure sexual function (PROMIS SexFS), fertility-related distress (RCAC), body image (BIS), anxiety and depression (HADS), and health-related quality of life (QLQ-C30); Self-efficacy and fertility-related knowledge will be assessed by study-specific measures. The survey will be administered to participants at baseline (approximately 1.5 year after diagnosis) and at 3 and 5 years post-diagnosis. Registry data will be used to collect clinical variables. A comparison group of 2000 young adults will be drawn from the Swedish population register (SPAR) and subsequently approached with the same measures as the cancer group.Discussion: The study will determine the prevalence and predictors of sexual dysfunction and fertility-related distress in young men and women with cancer. The findings will form a basis for developing interventions to alleviate sexual problems and fertility-related distress in young adults with cancer in the short and long term.Trial Registration: This is an observational cohort study and clinical trial registration was therefore not obtained. [ABSTRACT FROM AUTHOR]

Background: There is a growing understanding that well-being and mental illness are 2 separate dimensions of mental health. High well-being is associated with decreased risk of disease and mental illness and increased longevity. Objective: This study aims to test the efficacy of a mobile phone–based intervention on positive mental health. Methods: We are conducting a 2-armed randomized controlled trial of university students in Sweden. Recruitment will last for 6 months by digital advertising (eg, university websites). Participants will be randomly allocated to either an intervention (fully automated mobile phone–based mental health intervention) or control group (treatment as usual). The primary outcome will be self-assessed positive mental health (Mental Health Continuum Short Form). Secondary outcomes will be self-assessed depression anxiety symptomatology (Hospital Anxiety Depression Scale). Outcomes will be investigated at baseline, at 3, 6, and 12 months after randomization. Mediators (positive emotions and thoughts) will be investigated at baseline, midintervention, and at follow-ups using 2 single face-valid items. Results: Data will be collected between autumn 2018 and spring 2019. Results are expected to be published in 2020. Conclusions: Strengths of the study include the use of a validated comprehensive instrument to measure positive mental health. Mechanisms of change are also investigated. A potential challenge could be recruitment; however, by setting a prolonged recruitment period, we believe that the study will recruit a sufficient sample. Trial Registration: International Standard Randomized Controlled Trial Number: 54748632; http://www.isrctn.com/ ISRCTN54748632 International Registered Report Identifier (IRRID): PRR1-10.2196/12396 We help JMIR researchers to raise funds to pursue their research and development aimed at tackling important health and technology challenges. If you would like to show your support for this author, please donate using the button below. The funds raised will directly benefit the corresponding author of this article (minus 8% admin fees). Your donations will help this author to continue publishing open access papers in JMIR journals. Donations of over $100 may also be acknowledged in future publications. Suggested contribution levels: $20/$50/$100 [ABSTRACT FROM AUTHOR]

Background: Patients who have undergone radical cystectomy for urinary bladder cancer are not sufficiently physically active and therefore may suffer complications leading to readmissions. A physical rehabilitation programme early postoperatively might prevent or at least alleviate these potential complications and improve physical function. The main aim of the CanMoRe trial is to evaluate the impact of a standardised and individually adapted exercise intervention in primary health care to improve physical function (primary outcome) and habitual physical activity, health-related quality of life, fatigue, psychological wellbeing and readmissions due to complications in patients undergoing robotic-assisted radical cystectomy for urinary bladder cancer.Methods: In total, 120 patients will be included and assigned to either intervention or control arm of the study. All patients will receive preoperative information on the importance of early mobilisation and during the hospital stay they will follow a standard protocol for enhanced mobilisation. The intervention group will be given a referral to a physiotherapist in primary health care close to their home. Within the third week after discharge, the intervention group will begin 12 weeks of biweekly exercise. The exercise programme includes aerobic and strengthening exercises. The control group will receive oral and written information about a home-based exercise programme. Physical function will serve as the primary outcome and will be measured using the Six-minute walk test. Secondary outcomes are gait speed, handgrip strength, leg strength, habitual physical activity, health-related quality of life, fatigue, psychological wellbeing and readmissions due to complications. The measurements will be conducted at discharge (i.e. baseline), post-intervention and 1 year after surgery. To evaluate the effects of the intervention mixed or linear regression models according to the intention to treat procedure will be used.Discussion: This proposed randomised controlled trial has the potential to provide new knowledge within rehabilitation after radical cystectomy for urinary bladder cancer. The programme should be easy to apply to other patient groups undergoing abdominal surgery for cancer and has the potential to change the health care chain for these patients.Trial Registration: ClinicalTrials.gov. Clinical trial registration number NCT03998579 . First posted June 26, 2019. [ABSTRACT FROM AUTHOR]