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Background: Patient reported outcomes (PROs) have an integral role on how to improve patients' overall experience. The optimal PROs delivery in patients with breast disease is an important issue since PROs are steadily integrated in routine care. Methods: An institutional phase 3 randomised controlled, open-label trial. Eligible candidates were adult women with perceived or confirmed breast disease. Computer generated randomization was used to allocate interventions: collection of PROs in electronic or paper form. Our objective was the effectiveness of electronic versus paper form of PROs. The main outcome measures were: response rate, reported experience, administrative resources, and carbon dioxide emissions. Results: Two hundred thirty-eight patients were randomised. After loss-to-follow-up and consent withdrawals, 218 participants (median age, IQR=55, 21; n=110/n=108) were included in the per-intention-to-treat analysis. Response rate was 61.8% for electronic patient reported outcomes (ePROs) and 63.9% for paper patient reported outcomes (pPROs) (difference=-2.1%, 95% CI: -15.8-11.7%). Only known breast cancer at recruitment was predictive for response in multivariable analysis. ePROs were associated with a 57% reduction in administrative time required, a 95% reduction in incremental costs, and 84% reduction in carbon dioxide emissions, all differences being significant. No difference was detected in perception of PRO significance or ease of completion, but participants experienced that they needed less time to complete ePROs [median, (IQR) 10 (9) respectively 15(10)]. Finally, respondents would prefer ePROs over pPROs (difference 48.1%, 95% CI: 32.8-63.4%). Conclusion: ePROs do not increase the response rate in patients with perceived or confirmed breast disease. However, they can enhance patient experience, reduce incremental costs, facilitate administrative logistics, and are more sustainable. On the basis of these findings, both modalities should continue to, De två första författarna delar förstaförfattarskapet.De två sista författarna delar sistaförfattarskapet.

Aim: We evaluated the effect on body mass index standard deviation score (BMI-SDS) of a combined treatment (Web-COP) for children with obesity, including a web-based component targeting their parents. Methods: This randomised controlled trial recruited children 5–12 years of age with obesity (International Obesity Task Force BMI [IOTF-BMI] ≥30 kg/m2) from school health care and outpatient paediatric clinics in in Northern Sweden from 1 June 2019 to 21 June 2020. The children were randomised to Web-COP, an intervention with group sessions and a 12-week web-based component, or standard care. The primary outcome was the change in IOTF BMI-SDS after 6 months. Results: In total, 75 children (33 girls), mean age 9.5 years, were randomised, and 65/75 (87%) children and their parents completed the study, 35/39 (90%) in the Web-COP intervention and 30/36 (83%) in the standard care group. BMI-SDS at 6 months was changed from 3.08 to 2.81 in the intervention group compared to an increase from 3.07 to 3.16 in the standard care group, representing a significant difference between groups (p < 0.001). In the intervention group, 14/30 (47%) reduced their BMI-SDS ≥0.25, compared to none in the standard care group. Conclusion: The parent-focused intervention significantly improved BMI-SDS in children with obesity as compared to children in standard care.

Background: Patient reported outcomes (PROs) have an integral role on how to improve patients' overall experience. The optimal PROs delivery in patients with breast disease is an important issue since PROs are steadily integrated in routine care. Methods: An institutional phase 3 randomised controlled, open-label trial. Eligible candidates were adult women with perceived or confirmed breast disease. Computer generated randomization was used to allocate interventions: collection of PROs in electronic or paper form. Our objective was the effectiveness of electronic versus paper form of PROs. The main outcome measures were: response rate, reported experience, administrative resources, and carbon dioxide emissions. Results: Two hundred thirty-eight patients were randomised. After loss-to-follow-up and consent withdrawals, 218 participants (median age, IQR=55, 21; n=110/n=108) were included in the per-intention-to-treat analysis. Response rate was 61.8% for electronic patient reported outcomes (ePROs) and 63.9% for paper patient reported outcomes (pPROs) (difference=-2.1%, 95% CI: -15.8-11.7%). Only known breast cancer at recruitment was predictive for response in multivariable analysis. ePROs were associated with a 57% reduction in administrative time required, a 95% reduction in incremental costs, and 84% reduction in carbon dioxide emissions, all differences being significant. No difference was detected in perception of PRO significance or ease of completion, but participants experienced that they needed less time to complete ePROs [median, (IQR) 10 (9) respectively 15(10)]. Finally, respondents would prefer ePROs over pPROs (difference 48.1%, 95% CI: 32.8-63.4%). Conclusion: ePROs do not increase the response rate in patients with perceived or confirmed breast disease. However, they can enhance patient experience, reduce incremental costs, facilitate administrative logistics, and are more sustainable. On the basis of these findings, both modalities should continue to, De två första författarna delar förstaförfattarskapet.De två sista författarna delar sistaförfattarskapet.

Background: Patient reported outcomes (PROs) have an integral role on how to improve patients' overall experience. The optimal PROs delivery in patients with breast disease is an important issue since PROs are steadily integrated in routine care. Methods: An institutional phase 3 randomised controlled, open-label trial. Eligible candidates were adult women with perceived or confirmed breast disease. Computer generated randomization was used to allocate interventions: collection of PROs in electronic or paper form. Our objective was the effectiveness of electronic versus paper form of PROs. The main outcome measures were: response rate, reported experience, administrative resources, and carbon dioxide emissions. Results: Two hundred thirty-eight patients were randomised. After loss-to-follow-up and consent withdrawals, 218 participants (median age, IQR=55, 21; n=110/n=108) were included in the per-intention-to-treat analysis. Response rate was 61.8% for electronic patient reported outcomes (ePROs) and 63.9% for paper patient reported outcomes (pPROs) (difference=-2.1%, 95% CI: -15.8-11.7%). Only known breast cancer at recruitment was predictive for response in multivariable analysis. ePROs were associated with a 57% reduction in administrative time required, a 95% reduction in incremental costs, and 84% reduction in carbon dioxide emissions, all differences being significant. No difference was detected in perception of PRO significance or ease of completion, but participants experienced that they needed less time to complete ePROs [median, (IQR) 10 (9) respectively 15(10)]. Finally, respondents would prefer ePROs over pPROs (difference 48.1%, 95% CI: 32.8-63.4%). Conclusion: ePROs do not increase the response rate in patients with perceived or confirmed breast disease. However, they can enhance patient experience, reduce incremental costs, facilitate administrative logistics, and are more sustainable. On the basis of these findings, both modalities should continue to, De två första författarna delar förstaförfattarskapet.De två sista författarna delar sistaförfattarskapet.

Aim: We evaluated the effect on body mass index standard deviation score (BMI-SDS) of a combined treatment (Web-COP) for children with obesity, including a web-based component targeting their parents. Methods: This randomised controlled trial recruited children 5–12 years of age with obesity (International Obesity Task Force BMI [IOTF-BMI] ≥30 kg/m2) from school health care and outpatient paediatric clinics in in Northern Sweden from 1 June 2019 to 21 June 2020. The children were randomised to Web-COP, an intervention with group sessions and a 12-week web-based component, or standard care. The primary outcome was the change in IOTF BMI-SDS after 6 months. Results: In total, 75 children (33 girls), mean age 9.5 years, were randomised, and 65/75 (87%) children and their parents completed the study, 35/39 (90%) in the Web-COP intervention and 30/36 (83%) in the standard care group. BMI-SDS at 6 months was changed from 3.08 to 2.81 in the intervention group compared to an increase from 3.07 to 3.16 in the standard care group, representing a significant difference between groups (p < 0.001). In the intervention group, 14/30 (47%) reduced their BMI-SDS ≥0.25, compared to none in the standard care group. Conclusion: The parent-focused intervention significantly improved BMI-SDS in children with obesity as compared to children in standard care.

Objective To evaluate the contemporary growth rate of small abdominal aortic aneurysms (AAAs) in view of recent epidemiological changes, such as decreasing smoking rates and establishment of population screening programmes. Data sources MEDLINE, CENTRAL, PsycINFO, Web of Science Core Collection, and OpenGrey databases. Review methods Systematic review following the PRISMA guidelines. In October 2021, databases were queried for studies reporting on AAA growth rates published from 2015 onwards. The primary outcome was contemporary AAA growth rates in mm/year. Data were pooled in a random effects model meta-analysis, and heterogeneity was assessed through the I2 statistic. GRADE assessment of the findings was performed. The protocol was published in PROSPERO (CRD42022297404). Results Of 8 717 titles identified, 43 studies and 28 277 patients were included: 1 241 patients from randomised controlled trials (RCTs), 23 941 from clinical observational studies, and 3 095 from radiological or translational research studies. The mean AAA growth rate was 2.38 mm/year (95% CI 2.16 – 2.60 mm/year; GRADE = low), with meta-regression analysis adjusted for baseline diameter showing an increase of 0.08 mm/year (95% CI 0.024 – 0.137 mm/year; p = .005) for each millimetre of increased baseline diameter. When analysed by study type, the growth rate estimated from RCTs was 1.88 mm/year (95% CI 1.69 – 2.06 mm/year; GRADE = high), while it was 2.31 mm/year (95% CI 1.95 – 2.67 mm/year; GRADE = moderate) from clinical observational studies, and 2.85 mm/year (95% CI 2.44 – 3.26 mm/year; GRADE = low) from translational and radiology based studies (p < .001). Heterogeneity was high, and small study publication bias was present (p = .003), with 27 studies presenting a moderate to high risk of bias. The estimated growth rate from low risk studies was 2.09 mm/year (95% CI 1.87 – 2.32; GRADE = high). Conclusion This study estimated a contemporaneous AAA growth rate of 2.38 mm/year, being unable

Background: Patient reported outcomes (PROs) have an integral role on how to improve patients' overall experience. The optimal PROs delivery in patients with breast disease is an important issue since PROs are steadily integrated in routine care. Methods: An institutional phase 3 randomised controlled, open-label trial. Eligible candidates were adult women with perceived or confirmed breast disease. Computer generated randomization was used to allocate interventions: collection of PROs in electronic or paper form. Our objective was the effectiveness of electronic versus paper form of PROs. The main outcome measures were: response rate, reported experience, administrative resources, and carbon dioxide emissions. Results: Two hundred thirty-eight patients were randomised. After loss-to-follow-up and consent withdrawals, 218 participants (median age, IQR=55, 21; n=110/n=108) were included in the per-intention-to-treat analysis. Response rate was 61.8% for electronic patient reported outcomes (ePROs) and 63.9% for paper patient reported outcomes (pPROs) (difference=-2.1%, 95% CI: -15.8-11.7%). Only known breast cancer at recruitment was predictive for response in multivariable analysis. ePROs were associated with a 57% reduction in administrative time required, a 95% reduction in incremental costs, and 84% reduction in carbon dioxide emissions, all differences being significant. No difference was detected in perception of PRO significance or ease of completion, but participants experienced that they needed less time to complete ePROs [median, (IQR) 10 (9) respectively 15(10)]. Finally, respondents would prefer ePROs over pPROs (difference 48.1%, 95% CI: 32.8-63.4%). Conclusion: ePROs do not increase the response rate in patients with perceived or confirmed breast disease. However, they can enhance patient experience, reduce incremental costs, facilitate administrative logistics, and are more sustainable. On the basis of these findings, both modalities should continue to, De två första författarna delar förstaförfattarskapet.De två sista författarna delar sistaförfattarskapet.

BAKGRUND: Healthy sleep practices for children should be promoted as an essential part of a healthy lifestyle, with important implications for the entire family. Unhealthy sleep patterns and sleep-related problems disrupt everyday life and functioning. Sleep problems are common among children, especially those with attention deficit hyperactivity disorder (ADHD). Weighted blankets are one type of non-pharmacological intervention that has been used in health-care settings, such as occupational therapy practice. However, evidence is scarce and knowledge is lacking concerning the effects of weighted blankets on sleep and their potential benefits. Given the challenges children with ADHD face in sleep problems and emotional and behavioural regulation, weighted blankets could be a particular relevant intervention. The SLEEP project was thus designed to increase current evidence and knowledge about the use of weighted blankets as a sleep intervention for children with ADHD. AIM: The overall aim of this thesis was to investigate the impact of weighted blankets on the sleep health of children with ADHD and sleep problems. METHODS: A crossover randomised controlled trial (Study I) was conducted that included 94 children with ADHD, 6-14 years old. Children were randomly assigned to four weeks of a weighted blanket or four weeks of a lighter control blanket, followed by the other intervention. Data was collected with actigraphy (primary outcome), child- and parent-questionnaires and a daily sleep diary. The efficacy of weighted blankets was analysed with a paired t-test. An experimental longitudinal study (Study II) was carried out that involved the same 94 children, who were followed for 16 weeks. Weighted blanket-adherent vs non-adherent children were compared based on sample characteristics and changed sleep outcomes. The data collected at baseline, at 4 weeks, 8 weeks and at 16-week follow-up were analysed with mixed effect models. Weighted blanket-adherent children were f

BAKGRUND: Healthy sleep practices for children should be promoted as an essential part of a healthy lifestyle, with important implications for the entire family. Unhealthy sleep patterns and sleep-related problems disrupt everyday life and functioning. Sleep problems are common among children, especially those with attention deficit hyperactivity disorder (ADHD). Weighted blankets are one type of non-pharmacological intervention that has been used in health-care settings, such as occupational therapy practice. However, evidence is scarce and knowledge is lacking concerning the effects of weighted blankets on sleep and their potential benefits. Given the challenges children with ADHD face in sleep problems and emotional and behavioural regulation, weighted blankets could be a particular relevant intervention. The SLEEP project was thus designed to increase current evidence and knowledge about the use of weighted blankets as a sleep intervention for children with ADHD. AIM: The overall aim of this thesis was to investigate the impact of weighted blankets on the sleep health of children with ADHD and sleep problems. METHODS: A crossover randomised controlled trial (Study I) was conducted that included 94 children with ADHD, 6-14 years old. Children were randomly assigned to four weeks of a weighted blanket or four weeks of a lighter control blanket, followed by the other intervention. Data was collected with actigraphy (primary outcome), child- and parent-questionnaires and a daily sleep diary. The efficacy of weighted blankets was analysed with a paired t-test. An experimental longitudinal study (Study II) was carried out that involved the same 94 children, who were followed for 16 weeks. Weighted blanket-adherent vs non-adherent children were compared based on sample characteristics and changed sleep outcomes. The data collected at baseline, at 4 weeks, 8 weeks and at 16-week follow-up were analysed with mixed effect models. Weighted blanket-adherent children were f

INTRODUCTION: The absence of reliable prognostic markers poses a challenge to the management of inflammatory bowel disease (IBD). Patients with aggressive disease may not receive sufficient treatment with conventional 'step-up' therapy, whereas a top-down approach may expose patients with indolent disease to unnecessary treatment-related toxicity. The objective of the Nordic IBD treatment strategy trial (NORDTREAT) is to assess the feasibility of personalised therapy by stratifying patients according to a prognostic serum protein signature at diagnosis. METHODS AND ANALYSIS: NORDTREAT is a multicentre, biomarker-strategy design, open-label controlled trial. After screening consent, eligible patients are randomised (1:1) into one of two groups: a group with access to the protein signature and a group without access. In the access to protein signature group, patients displaying a protein signature suggestive of an increased risk of an aggressive disease course will be treated in line with a top-down treatment algorithm (anti-tumour necrosis factor agent with/without an immunomodulator). In contrast, those with a protein signature indicative of indolent disease will be excluded from the trial. Patients not in the access group receive treatment based on clinical management. This traditional management involves a stepwise escalation of treatment as determined by the investigator after failure of first-line treatment. After 52 weeks, outcomes are assessed in the subgroup of patients with a protein profile indicating a potentially severe disease trajectory. The primary endpoint is a composite of the proportion of patients with corticosteroid-free clinical and endoscopic remission at week 52. Surgical intervention due to IBD during follow-up will be defined as treatment failure. ETHICS AND DISSEMINATION: Ethical approval has been obtained, and recruitment is underway at sites in four participating Nordic countries (Denmark, Iceland, Norway and Sweden). Following trial compl, This work was supported by Nordforsk (grant number 90569 NORDTREAT to JH) and financially supported by Vinnova (grant number 2019-01185 NORDTREAT to JH), Innovation Fund Denmark (rant number 8114-00026B to JK and VA), Rannis (grant number 90569 - Project no. 199782-0611 to LD) and by The Research Council of Norway (grant number 2988039 to MLH). Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital are supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL).

BAKGRUND: Healthy sleep practices for children should be promoted as an essential part of a healthy lifestyle, with important implications for the entire family. Unhealthy sleep patterns and sleep-related problems disrupt everyday life and functioning. Sleep problems are common among children, especially those with attention deficit hyperactivity disorder (ADHD). Weighted blankets are one type of non-pharmacological intervention that has been used in health-care settings, such as occupational therapy practice. However, evidence is scarce and knowledge is lacking concerning the effects of weighted blankets on sleep and their potential benefits. Given the challenges children with ADHD face in sleep problems and emotional and behavioural regulation, weighted blankets could be a particular relevant intervention. The SLEEP project was thus designed to increase current evidence and knowledge about the use of weighted blankets as a sleep intervention for children with ADHD. AIM: The overall aim of this thesis was to investigate the impact of weighted blankets on the sleep health of children with ADHD and sleep problems. METHODS: A crossover randomised controlled trial (Study I) was conducted that included 94 children with ADHD, 6-14 years old. Children were randomly assigned to four weeks of a weighted blanket or four weeks of a lighter control blanket, followed by the other intervention. Data was collected with actigraphy (primary outcome), child- and parent-questionnaires and a daily sleep diary. The efficacy of weighted blankets was analysed with a paired t-test. An experimental longitudinal study (Study II) was carried out that involved the same 94 children, who were followed for 16 weeks. Weighted blanket-adherent vs non-adherent children were compared based on sample characteristics and changed sleep outcomes. The data collected at baseline, at 4 weeks, 8 weeks and at 16-week follow-up were analysed with mixed effect models. Weighted blanket-adherent children were f

Background: Opportunistic salpingectomy to reduce ovarian cancer incidence has become increasingly common despite the lack of randomised trials investigating its safety. In SALSTER, we tested whether salpingectomy for laparoscopic sterilisation is non-inferior to tubal occlusion regarding complications up to eight weeks postoperatively. Methods: SALSTER is a register-based randomised non-inferiority trial in which 41 gynaecological departments in Sweden participated. After being reported to The Swedish National Quality Register of Gynaecological Surgery (GynOp) for laparoscopic sterilisation, women aged <50 years received study information and could consent to participation online. If eligible, randomisation was performed by the examining/operating gynaecologist before surgery, with stratification for centre, and allocation 1:1 to salpingectomy or tubal occlusion. Blinding was attempted for patients but was impossible for surgeons. The first primary outcome, any complication up to eight weeks postoperatively, was routinely reported in GynOp through physician assessment of patient questionnaires, medical records and personal contact. Complications up to eight weeks postoperatively, a primary safety outcome, were analysed in the per-protocol population. The non-inferiority margin for the difference in the absolute risk of complications was defined as ten percentage points. Missing data were handled using multiple imputation. SALSTER was registered at ClinicalTrials.gov (NCT03860805). Findings: Between April 4, 2019, and March 31, 2023, 539 women were randomised to salpingectomy and 527 to tubal occlusion. In the salpingectomy and tubal occlusion arms, 40 and 18 women discontinued their participation in the trial and another 26 and 10 did not receive the allocated surgery, respectively. Calculated on imputed data, any complication up to eight weeks postoperatively occurred in 8.1% (38.5/473) of patients after salpingectomy and in 6.2% (31.0/499) of patients after tu

INTRODUCTION: The absence of reliable prognostic markers poses a challenge to the management of inflammatory bowel disease (IBD). Patients with aggressive disease may not receive sufficient treatment with conventional 'step-up' therapy, whereas a top-down approach may expose patients with indolent disease to unnecessary treatment-related toxicity. The objective of the Nordic IBD treatment strategy trial (NORDTREAT) is to assess the feasibility of personalised therapy by stratifying patients according to a prognostic serum protein signature at diagnosis. METHODS AND ANALYSIS: NORDTREAT is a multicentre, biomarker-strategy design, open-label controlled trial. After screening consent, eligible patients are randomised (1:1) into one of two groups: a group with access to the protein signature and a group without access. In the access to protein signature group, patients displaying a protein signature suggestive of an increased risk of an aggressive disease course will be treated in line with a top-down treatment algorithm (anti-tumour necrosis factor agent with/without an immunomodulator). In contrast, those with a protein signature indicative of indolent disease will be excluded from the trial. Patients not in the access group receive treatment based on clinical management. This traditional management involves a stepwise escalation of treatment as determined by the investigator after failure of first-line treatment. After 52 weeks, outcomes are assessed in the subgroup of patients with a protein profile indicating a potentially severe disease trajectory. The primary endpoint is a composite of the proportion of patients with corticosteroid-free clinical and endoscopic remission at week 52. Surgical intervention due to IBD during follow-up will be defined as treatment failure. ETHICS AND DISSEMINATION: Ethical approval has been obtained, and recruitment is underway at sites in four participating Nordic countries (Denmark, Iceland, Norway and Sweden). Following trial compl

Background: Opportunistic salpingectomy to reduce ovarian cancer incidence has become increasingly common despite the lack of randomised trials investigating its safety. In SALSTER, we tested whether salpingectomy for laparoscopic sterilisation is non-inferior to tubal occlusion regarding complications up to eight weeks postoperatively. Methods: SALSTER is a register-based randomised non-inferiority trial in which 41 gynaecological departments in Sweden participated. After being reported to The Swedish National Quality Register of Gynaecological Surgery (GynOp) for laparoscopic sterilisation, women aged <50 years received study information and could consent to participation online. If eligible, randomisation was performed by the examining/operating gynaecologist before surgery, with stratification for centre, and allocation 1:1 to salpingectomy or tubal occlusion. Blinding was attempted for patients but was impossible for surgeons. The first primary outcome, any complication up to eight weeks postoperatively, was routinely reported in GynOp through physician assessment of patient questionnaires, medical records and personal contact. Complications up to eight weeks postoperatively, a primary safety outcome, were analysed in the per-protocol population. The non-inferiority margin for the difference in the absolute risk of complications was defined as ten percentage points. Missing data were handled using multiple imputation. SALSTER was registered at ClinicalTrials.gov (NCT03860805). Findings: Between April 4, 2019, and March 31, 2023, 539 women were randomised to salpingectomy and 527 to tubal occlusion. In the salpingectomy and tubal occlusion arms, 40 and 18 women discontinued their participation in the trial and another 26 and 10 did not receive the allocated surgery, respectively. Calculated on imputed data, any complication up to eight weeks postoperatively occurred in 8.1% (38.5/473) of patients after salpingectomy and in 6.2% (31.0/499) of patients after tu

Background Non-cardiac chest pain (NCCP) is a common issue, accounting for roughly half of all emergency department visits related to chest pain. Patients afflicted with NCCP often endure cardiac anxiety, misinterpreting the pain as heart-related and fearing it, despite the absence of any life-threatening cardiac issues. This anxiety often leads to the avoidance of physical activities, negatively impacting their quality of life. Cognitive behavioural therapy (CBT) has been shown to be effective in managing psychological distress such as anxiety and depression. CBT is a structured process that helps patients identify and restructure their negative thoughts, get a corrected and more realistic perception of their symptoms, and learn to manage their thoughts about chest pain. Despite its effectiveness, CBT is resource-intensive, and therefore internet-delivered cognitive behavioural therapy (iCBT) may be an alternative as it increases accessibility and is more cost-effective compared to traditional therapy methods. However, there is a lack of re-search on the effectiveness of this treatment approach for patients with NCCP and cardiac anxiety. Moreover, digital care technologies are still relatively unfamiliar in clinical practice, particularly in emergency departments, and the successful implementation of iCBT relies on healthcare professionals' acceptance and integration of digital care into clinical practice. Aim The overall aim of this dissertation was to evaluate the short- and long-term effects of a nurse-led iCBT program on psychological distress in patients with NCCP, and to explore their experiences participating in the iCBT program. In addition, the study aimed to describe healthcare professionals' perceptions of digital care in the emergency and cardiac care for patients with NCCP. Methods This dissertation comprises two quantitative and two qualitative studies. A randomised clinical trial (RCT) (studies I, II, and III) was conducted to evaluate cardia, Bakgrund Icke-kardiell bröstsmärta (Non-cardiac chest pain - NCCP) är ett vanligt problem och utgör ungefär hälften av alla besök på akutmottagningen relaterade till bröstsmärta. Patienter som besväras av NCCP upplever ofta hjärtrelaterad ångest då de tolkar smärtan som hjärtspecifik, trots att ingen livshotande hjärtsjukdom konstaterats. Hjärtrelaterad ångest leder ofta till att de undviker fysisk aktivitet eller sociala situationer på grund av rädsla för att förvärra symtom eller uppleva komplikationer, vilket påverkar livs-kvaliteten negativt. Kognitiv beteendeterapi (KBT) har visat sig vara effektiv för att hantera psykisk ohälsa såsom ångest och depression. KBT är en strukturerad process som hjälper patienter att identifiera och omstrukturera sina negativa tankar, få en korrigerad och mer realistisk uppfattning om sina symtom och lära sig att hantera sina tankar om bröstsmärtan. Trots sin effektivitet är KBT resurskrävande och därför kan internetbaserad kognitiv beteendeterapi (iKBT) vara ett alternativ eftersom den ökar tillgängligheten och är mer kostnadseffektiv jämfört med traditionell KBT. Dock saknas det forskning kring effekten av denna behandlingsform för patienter med NCCP och hjärtrelaterad ångest. Dessutom är digitala vård-teknologier fortfarande relativt okända inom kliniska miljöer, särskilt på akutmottagningar, och en framgångsrik implementering av digitala behandlingsformer, såsom iKBT beror till stor del vårdpersonalens acceptans och integration av digital vård i klinisk praxis. Syfte Det övergripande syftet med denna avhandling var att utvärdera kort- och långsiktiga effekter av ett sjuksköterskelett iKBT-program på psykisk ohälsa hos patienter med NCCP, samt att utforska deras erfarenheter av att delta i iKBT-programmet. Dessutom syftade studien till att beskriva sjukvårdpersonals uppfattningar om digital vård inom akut- och hjärtsjukvården för patienter med NCCP. Metod Denna avhandling består av två kvantitativa och två kvalitativa stud, Funding: The Kamprad Family Foundation and Region Östergötland

Background: Patient reported outcomes (PROs) have an integral role on how to improve patients' overall experience. The optimal PROs delivery in patients with breast disease is an important issue since PROs are steadily integrated in routine care. Methods: An institutional phase 3 randomised controlled, open-label trial. Eligible candidates were adult women with perceived or confirmed breast disease. Computer generated randomization was used to allocate interventions: collection of PROs in electronic or paper form. Our objective was the effectiveness of electronic versus paper form of PROs. The main outcome measures were: response rate, reported experience, administrative resources, and carbon dioxide emissions. Results: Two hundred thirty-eight patients were randomised. After loss-to-follow-up and consent withdrawals, 218 participants (median age, IQR=55, 21; n=110/n=108) were included in the per-intention-to-treat analysis. Response rate was 61.8% for electronic patient reported outcomes (ePROs) and 63.9% for paper patient reported outcomes (pPROs) (difference=-2.1%, 95% CI: -15.8-11.7%). Only known breast cancer at recruitment was predictive for response in multivariable analysis. ePROs were associated with a 57% reduction in administrative time required, a 95% reduction in incremental costs, and 84% reduction in carbon dioxide emissions, all differences being significant. No difference was detected in perception of PRO significance or ease of completion, but participants experienced that they needed less time to complete ePROs [median, (IQR) 10 (9) respectively 15(10)]. Finally, respondents would prefer ePROs over pPROs (difference 48.1%, 95% CI: 32.8-63.4%). Conclusion: ePROs do not increase the response rate in patients with perceived or confirmed breast disease. However, they can enhance patient experience, reduce incremental costs, facilitate administrative logistics, and are more sustainable. On the basis of these findings, both modalities should continue to, De två första författarna delar förstaförfattarskapet.De två sista författarna delar sistaförfattarskapet.

Background and Purpose To investigate the effect of topical non-invasive physical plasma (NIPP), a volatile mix generated out of ambient air, on prevention of acute radiation dermatitis (RD) during and after whole-breast irradiation (WBI). Materials and Methods Lateral and medial breast halves were randomised within each patient to receive either 120 s of NIPP or sham treatment daily during WBI. Standard skin care with urea lotion was applied to the whole breast. Blinded acute skin toxicity was assessed weekly for each breast half separately and included clinician-(CTCAE) and patient-reported (modified RISRAS), and objective (spectrophotometry) assessments. As an additional external control, a comparable standard of care (SoC) patient collective from a previous prospective trial was used. Results Sixty-four patients were included. There were no significant differences between breast halves. Post-hoc comparison with a similar SoC control collective revealed OR = 0.28 (95% CI 0.11–0.76; p = 0.014) for grade ≥ 2 RD upon WBI completion, along with less hyperpigmentation (p < 0.001), oedema (p = 0.020), dry (p < 0.001) and moist desquamation (p = 0.017), pain, itching, and burning (p < 0.001 for each). Tolerability of NIPP was excellent and side effects were not observed. Conclusion Even though there were no differences between intrapatient-randomised breast halves, the overall incidence and severity of acute radiation-induced skin toxicity were considerably lower when compared to a prospectively collected SoC cohort. Our data suggest the potential benefit of NIPP in RD prevention. A randomised trial with a physical control group is warranted to confirm these promising results (DRKS00026225).

Aim: We evaluated the effect on body mass index standard deviation score (BMI-SDS) of a combined treatment (Web-COP) for children with obesity, including a web-based component targeting their parents. Methods: This randomised controlled trial recruited children 5–12 years of age with obesity (International Obesity Task Force BMI [IOTF-BMI] ≥30 kg/m2) from school health care and outpatient paediatric clinics in in Northern Sweden from 1 June 2019 to 21 June 2020. The children were randomised to Web-COP, an intervention with group sessions and a 12-week web-based component, or standard care. The primary outcome was the change in IOTF BMI-SDS after 6 months. Results: In total, 75 children (33 girls), mean age 9.5 years, were randomised, and 65/75 (87%) children and their parents completed the study, 35/39 (90%) in the Web-COP intervention and 30/36 (83%) in the standard care group. BMI-SDS at 6 months was changed from 3.08 to 2.81 in the intervention group compared to an increase from 3.07 to 3.16 in the standard care group, representing a significant difference between groups (p < 0.001). In the intervention group, 14/30 (47%) reduced their BMI-SDS ≥0.25, compared to none in the standard care group. Conclusion: The parent-focused intervention significantly improved BMI-SDS in children with obesity as compared to children in standard care.

Aim: We evaluated the effect on body mass index standard deviation score (BMI-SDS) of a combined treatment (Web-COP) for children with obesity, including a web-based component targeting their parents. Methods: This randomised controlled trial recruited children 5–12 years of age with obesity (International Obesity Task Force BMI [IOTF-BMI] ≥30 kg/m2) from school health care and outpatient paediatric clinics in in Northern Sweden from 1 June 2019 to 21 June 2020. The children were randomised to Web-COP, an intervention with group sessions and a 12-week web-based component, or standard care. The primary outcome was the change in IOTF BMI-SDS after 6 months. Results: In total, 75 children (33 girls), mean age 9.5 years, were randomised, and 65/75 (87%) children and their parents completed the study, 35/39 (90%) in the Web-COP intervention and 30/36 (83%) in the standard care group. BMI-SDS at 6 months was changed from 3.08 to 2.81 in the intervention group compared to an increase from 3.07 to 3.16 in the standard care group, representing a significant difference between groups (p < 0.001). In the intervention group, 14/30 (47%) reduced their BMI-SDS ≥0.25, compared to none in the standard care group. Conclusion: The parent-focused intervention significantly improved BMI-SDS in children with obesity as compared to children in standard care.

Seasonal price variability for cereals is two to three times higher in Africa than on the international reference market. Seasonality is even more pronounced when access to appropriate storage and opportunities for price arbitrage are limited. As smallholder farmers typically sell their production after harvest, when prices are low, this leads to lower incomes as well as higher food insecurity during the lean season, when prices are high. One solution to reduce seasonal stress is the use of improved storage technologies. Using data from a randomised controlled trial, in a major maize-growing region of Western Ethiopia, we study the impact of hermetic bags, a technology that protects stored grain against insect pests, so that the grain can be stored longer. Despite considerable price seasonality—maize prices in the lean season are 36% higher than after harvesting—we find no evidence that hermetic bags improve welfare, except that access to these bags allowed for a marginally longer storage period of maize intended for sale by 2 weeks. But this did not translate into measurable welfare gains as we found no changes in any of our welfare outcome indicators. This ‘near-null’ effect is due to the fact that maize storage losses in our study region are relatively lower than previous studies suggested—around 10% of the quantity stored—likely because of the widespread use of an alternative to protect maize during storage, for example a cheap but highly toxic fumigant. These findings are important for policies that seek to promote improved storage technologies in these settings.

A systematic review and meta-analysis were utilised to explore the methodological quality, program fidelity, and efficacy of social skills group programs (SSGPs) aiming to support autistic adolescents in navigating their everyday social worlds. The study evaluated the methodological quality and theoretical fidelity of studies, with a random effect meta-analysis conducted to summarise the overall efficacy of SSGP and its effect on social communication and interaction, behavioural/emotional challenges, adaptive functioning, and autism characteristics. Although findings from the 18 identified studies indicated an adjusted medium overall effect with these programs successfully supporting autistic adolescents’ socialisation needs (g = 0. 60, p < 0.001), most studies demonstrated medium to low program fidelity despite their good methodological quality. Given the significant heterogeneity of SSGPs and variations in the design and measurement frameworks of efficacy studies, understanding the generalisability of the findings of this research is unclear.

Background Non-cardiac chest pain (NCCP) is a common issue, accounting for roughly half of all emergency department visits related to chest pain. Patients afflicted with NCCP often endure cardiac anxiety, misinterpreting the pain as heart-related and fearing it, despite the absence of any life-threatening cardiac issues. This anxiety often leads to the avoidance of physical activities, negatively impacting their quality of life. Cognitive behavioural therapy (CBT) has been shown to be effective in managing psychological distress such as anxiety and depression. CBT is a structured process that helps patients identify and restructure their negative thoughts, get a corrected and more realistic perception of their symptoms, and learn to manage their thoughts about chest pain. Despite its effectiveness, CBT is resource-intensive, and therefore internet-delivered cognitive behavioural therapy (iCBT) may be an alternative as it increases accessibility and is more cost-effective compared to traditional therapy methods. However, there is a lack of re-search on the effectiveness of this treatment approach for patients with NCCP and cardiac anxiety. Moreover, digital care technologies are still relatively unfamiliar in clinical practice, particularly in emergency departments, and the successful implementation of iCBT relies on healthcare professionals' acceptance and integration of digital care into clinical practice. Aim The overall aim of this dissertation was to evaluate the short- and long-term effects of a nurse-led iCBT program on psychological distress in patients with NCCP, and to explore their experiences participating in the iCBT program. In addition, the study aimed to describe healthcare professionals' perceptions of digital care in the emergency and cardiac care for patients with NCCP. Methods This dissertation comprises two quantitative and two qualitative studies. A randomised clinical trial (RCT) (studies I, II, and III) was conducted to evaluate cardia, Bakgrund Icke-kardiell bröstsmärta (Non-cardiac chest pain - NCCP) är ett vanligt problem och utgör ungefär hälften av alla besök på akutmottagningen relaterade till bröstsmärta. Patienter som besväras av NCCP upplever ofta hjärtrelaterad ångest då de tolkar smärtan som hjärtspecifik, trots att ingen livshotande hjärtsjukdom konstaterats. Hjärtrelaterad ångest leder ofta till att de undviker fysisk aktivitet eller sociala situationer på grund av rädsla för att förvärra symtom eller uppleva komplikationer, vilket påverkar livs-kvaliteten negativt. Kognitiv beteendeterapi (KBT) har visat sig vara effektiv för att hantera psykisk ohälsa såsom ångest och depression. KBT är en strukturerad process som hjälper patienter att identifiera och omstrukturera sina negativa tankar, få en korrigerad och mer realistisk uppfattning om sina symtom och lära sig att hantera sina tankar om bröstsmärtan. Trots sin effektivitet är KBT resurskrävande och därför kan internetbaserad kognitiv beteendeterapi (iKBT) vara ett alternativ eftersom den ökar tillgängligheten och är mer kostnadseffektiv jämfört med traditionell KBT. Dock saknas det forskning kring effekten av denna behandlingsform för patienter med NCCP och hjärtrelaterad ångest. Dessutom är digitala vård-teknologier fortfarande relativt okända inom kliniska miljöer, särskilt på akutmottagningar, och en framgångsrik implementering av digitala behandlingsformer, såsom iKBT beror till stor del vårdpersonalens acceptans och integration av digital vård i klinisk praxis. Syfte Det övergripande syftet med denna avhandling var att utvärdera kort- och långsiktiga effekter av ett sjuksköterskelett iKBT-program på psykisk ohälsa hos patienter med NCCP, samt att utforska deras erfarenheter av att delta i iKBT-programmet. Dessutom syftade studien till att beskriva sjukvårdpersonals uppfattningar om digital vård inom akut- och hjärtsjukvården för patienter med NCCP. Metod Denna avhandling består av två kvantitativa och två kvalitativa stud, Funding: The Kamprad Family Foundation and Region Östergötland

Background Non-cardiac chest pain (NCCP) is a common issue, accounting for roughly half of all emergency department visits related to chest pain. Patients afflicted with NCCP often endure cardiac anxiety, misinterpreting the pain as heart-related and fearing it, despite the absence of any life-threatening cardiac issues. This anxiety often leads to the avoidance of physical activities, negatively impacting their quality of life. Cognitive behavioural therapy (CBT) has been shown to be effective in managing psychological distress such as anxiety and depression. CBT is a structured process that helps patients identify and restructure their negative thoughts, get a corrected and more realistic perception of their symptoms, and learn to manage their thoughts about chest pain. Despite its effectiveness, CBT is resource-intensive, and therefore internet-delivered cognitive behavioural therapy (iCBT) may be an alternative as it increases accessibility and is more cost-effective compared to traditional therapy methods. However, there is a lack of re-search on the effectiveness of this treatment approach for patients with NCCP and cardiac anxiety. Moreover, digital care technologies are still relatively unfamiliar in clinical practice, particularly in emergency departments, and the successful implementation of iCBT relies on healthcare professionals' acceptance and integration of digital care into clinical practice. Aim The overall aim of this dissertation was to evaluate the short- and long-term effects of a nurse-led iCBT program on psychological distress in patients with NCCP, and to explore their experiences participating in the iCBT program. In addition, the study aimed to describe healthcare professionals' perceptions of digital care in the emergency and cardiac care for patients with NCCP. Methods This dissertation comprises two quantitative and two qualitative studies. A randomised clinical trial (RCT) (studies I, II, and III) was conducted to evaluate cardia, Bakgrund Icke-kardiell bröstsmärta (Non-cardiac chest pain - NCCP) är ett vanligt problem och utgör ungefär hälften av alla besök på akutmottagningen relaterade till bröstsmärta. Patienter som besväras av NCCP upplever ofta hjärtrelaterad ångest då de tolkar smärtan som hjärtspecifik, trots att ingen livshotande hjärtsjukdom konstaterats. Hjärtrelaterad ångest leder ofta till att de undviker fysisk aktivitet eller sociala situationer på grund av rädsla för att förvärra symtom eller uppleva komplikationer, vilket påverkar livs-kvaliteten negativt. Kognitiv beteendeterapi (KBT) har visat sig vara effektiv för att hantera psykisk ohälsa såsom ångest och depression. KBT är en strukturerad process som hjälper patienter att identifiera och omstrukturera sina negativa tankar, få en korrigerad och mer realistisk uppfattning om sina symtom och lära sig att hantera sina tankar om bröstsmärtan. Trots sin effektivitet är KBT resurskrävande och därför kan internetbaserad kognitiv beteendeterapi (iKBT) vara ett alternativ eftersom den ökar tillgängligheten och är mer kostnadseffektiv jämfört med traditionell KBT. Dock saknas det forskning kring effekten av denna behandlingsform för patienter med NCCP och hjärtrelaterad ångest. Dessutom är digitala vård-teknologier fortfarande relativt okända inom kliniska miljöer, särskilt på akutmottagningar, och en framgångsrik implementering av digitala behandlingsformer, såsom iKBT beror till stor del vårdpersonalens acceptans och integration av digital vård i klinisk praxis. Syfte Det övergripande syftet med denna avhandling var att utvärdera kort- och långsiktiga effekter av ett sjuksköterskelett iKBT-program på psykisk ohälsa hos patienter med NCCP, samt att utforska deras erfarenheter av att delta i iKBT-programmet. Dessutom syftade studien till att beskriva sjukvårdpersonals uppfattningar om digital vård inom akut- och hjärtsjukvården för patienter med NCCP. Metod Denna avhandling består av två kvantitativa och två kvalitativa stud, Funding: The Kamprad Family Foundation and Region Östergötland

Over the last three decades, the ‘Housing First’ methodology has spread from North America to other countries. In 2014, the Hábitat program was launched in Spain — a country that was still suffering a profound economic crisis — following this model. This study is part of the socio-economic evaluation carried out between 2015 and 2020 through a randomised controlled trial. The treatment group was compared with a control group by monitoring their evolution over 18 months. We verified that it achieved significant improvements in most of the areas analysed, beyond specific housing services. As regards costs, it is clear that the programme involves a large investment in terms of housing but manages to offset some expenses in other areas and, above all, generates very valuable improvements in the lives of the participants. To end our article, we discuss the scope of these results and reflect on the limitations to be overcome in future evaluations of similar actions., En las últimas tres décadas la metodología Housing First se ha extendido desde Norteamérica a otros países. En 2014 se puso en marcha en España —cuando el país todavía estaba sumido en una profunda crisis económica— el programa Hábitat siguiendo ese modelo. Este estudio forma parte de la evaluación socioeconómica llevada a cabo entre 2015 y 2020 mediante un ensayo controlado aleatorizado. El grupo de tratamiento se comparó con un grupo de control haciendo un seguimiento de su evolución a lo largo de 18 meses. Comprobamos que logró mejoras significativas en la mayoría de áreas analizadas, más allá de los servicios específicos de vivienda. Respecto a los costes, resulta evidente que el programa supone una gran inversión en términos de vivienda, pero consigue compensar algunos gastos en otros apartados y, sobre todo, genera mejoras muy valiosas en las personas participantes. Para finalizar nuestro artículo, discutimos el alcance de estos resultados y reflexionamos sobre las limitaciones a superar en próximas evaluaciones de intervenciones similares.

Background: Living with and managing atrial fibrillation (AF) can be complex. Some people have no symptoms, while others have a significant symptom burden. Health-related quality of life (HRQoL) is often low and partly associated with symptom burden. However, the impact of the condition on daily life differs between those affected and is not fully understood. Therefore, more knowledge is needed about patients’ experiences of AF and factors influencing HRQoL. Research indicates that the care of patients with AF needs to change and be more based on personal preferences and values. Aim: The overall aim of this thesis was to explore patients’ experiences of AF and to evaluate the effects of a nurse-led, person-centred clinic. Methods: The thesis contains four studies. Study I was based on interviews with 15 patients about their experiences of living with symptomatic AF. Studies II and III were based on data from questionnaires completed before and 6 months after scheduled electrical cardioversion. Study II was a cross-sectional study with 52 women and 115 men describing illness perceptions and HRQoL and exploring their relationship. Study III was a longitudinal study comparing 53 newly diagnosed (<6 months) and 76 previously diagnosed patients with AF (≥6 months) regarding HRQoL, illness perceptions, symptoms, symptom burden, anxiety and depression. Study IV was a randomised controlled trial evaluating the effects of a nurse-led, person-centred clinic on patient-reported outcomes measures in patients with AF. Patients were randomly assigned to a nurse-led intervention group (n=50) or a control group with a physician visit (n=53) and completed questionnaires on the same subjects as in Study III at baseline before the visit to the clinic and 6 months after. Study I were analysed with qualitative content analysis. The other studies are quantitative and were analysed with descriptive statistics (Studies II–IV), comparative statistics (Studies II–IV), and correlation anal

Background Non-cardiac chest pain (NCCP) is a common issue, accounting for roughly half of all emergency department visits related to chest pain. Patients afflicted with NCCP often endure cardiac anxiety, misinterpreting the pain as heart-related and fearing it, despite the absence of any life-threatening cardiac issues. This anxiety often leads to the avoidance of physical activities, negatively impacting their quality of life. Cognitive behavioural therapy (CBT) has been shown to be effective in managing psychological distress such as anxiety and depression. CBT is a structured process that helps patients identify and restructure their negative thoughts, get a corrected and more realistic perception of their symptoms, and learn to manage their thoughts about chest pain. Despite its effectiveness, CBT is resource-intensive, and therefore internet-delivered cognitive behavioural therapy (iCBT) may be an alternative as it increases accessibility and is more cost-effective compared to traditional therapy methods. However, there is a lack of re-search on the effectiveness of this treatment approach for patients with NCCP and cardiac anxiety. Moreover, digital care technologies are still relatively unfamiliar in clinical practice, particularly in emergency departments, and the successful implementation of iCBT relies on healthcare professionals' acceptance and integration of digital care into clinical practice. Aim The overall aim of this dissertation was to evaluate the short- and long-term effects of a nurse-led iCBT program on psychological distress in patients with NCCP, and to explore their experiences participating in the iCBT program. In addition, the study aimed to describe healthcare professionals' perceptions of digital care in the emergency and cardiac care for patients with NCCP. Methods This dissertation comprises two quantitative and two qualitative studies. A randomised clinical trial (RCT) (studies I, II, and III) was conducted to evaluate cardia, Bakgrund Icke-kardiell bröstsmärta (Non-cardiac chest pain - NCCP) är ett vanligt problem och utgör ungefär hälften av alla besök på akutmottagningen relaterade till bröstsmärta. Patienter som besväras av NCCP upplever ofta hjärtrelaterad ångest då de tolkar smärtan som hjärtspecifik, trots att ingen livshotande hjärtsjukdom konstaterats. Hjärtrelaterad ångest leder ofta till att de undviker fysisk aktivitet eller sociala situationer på grund av rädsla för att förvärra symtom eller uppleva komplikationer, vilket påverkar livs-kvaliteten negativt. Kognitiv beteendeterapi (KBT) har visat sig vara effektiv för att hantera psykisk ohälsa såsom ångest och depression. KBT är en strukturerad process som hjälper patienter att identifiera och omstrukturera sina negativa tankar, få en korrigerad och mer realistisk uppfattning om sina symtom och lära sig att hantera sina tankar om bröstsmärtan. Trots sin effektivitet är KBT resurskrävande och därför kan internetbaserad kognitiv beteendeterapi (iKBT) vara ett alternativ eftersom den ökar tillgängligheten och är mer kostnadseffektiv jämfört med traditionell KBT. Dock saknas det forskning kring effekten av denna behandlingsform för patienter med NCCP och hjärtrelaterad ångest. Dessutom är digitala vård-teknologier fortfarande relativt okända inom kliniska miljöer, särskilt på akutmottagningar, och en framgångsrik implementering av digitala behandlingsformer, såsom iKBT beror till stor del vårdpersonalens acceptans och integration av digital vård i klinisk praxis. Syfte Det övergripande syftet med denna avhandling var att utvärdera kort- och långsiktiga effekter av ett sjuksköterskelett iKBT-program på psykisk ohälsa hos patienter med NCCP, samt att utforska deras erfarenheter av att delta i iKBT-programmet. Dessutom syftade studien till att beskriva sjukvårdpersonals uppfattningar om digital vård inom akut- och hjärtsjukvården för patienter med NCCP. Metod Denna avhandling består av två kvantitativa och två kvalitativa stud, Funding: The Kamprad Family Foundation and Region Östergötland

Background: Living with and managing atrial fibrillation (AF) can be complex. Some people have no symptoms, while others have a significant symptom burden. Health-related quality of life (HRQoL) is often low and partly associated with symptom burden. However, the impact of the condition on daily life differs between those affected and is not fully understood. Therefore, more knowledge is needed about patients’ experiences of AF and factors influencing HRQoL. Research indicates that the care of patients with AF needs to change and be more based on personal preferences and values. Aim: The overall aim of this thesis was to explore patients’ experiences of AF and to evaluate the effects of a nurse-led, person-centred clinic. Methods: The thesis contains four studies. Study I was based on interviews with 15 patients about their experiences of living with symptomatic AF. Studies II and III were based on data from questionnaires completed before and 6 months after scheduled electrical cardioversion. Study II was a cross-sectional study with 52 women and 115 men describing illness perceptions and HRQoL and exploring their relationship. Study III was a longitudinal study comparing 53 newly diagnosed (<6 months) and 76 previously diagnosed patients with AF (≥6 months) regarding HRQoL, illness perceptions, symptoms, symptom burden, anxiety and depression. Study IV was a randomised controlled trial evaluating the effects of a nurse-led, person-centred clinic on patient-reported outcomes measures in patients with AF. Patients were randomly assigned to a nurse-led intervention group (n=50) or a control group with a physician visit (n=53) and completed questionnaires on the same subjects as in Study III at baseline before the visit to the clinic and 6 months after. Study I were analysed with qualitative content analysis. The other studies are quantitative and were analysed with descriptive statistics (Studies II–IV), comparative statistics (Studies II–IV), and correlation anal

Background The war in South Sudan has displaced more than four million people, with Uganda hosting the largest number of South Sudanese refugees. Research in Uganda has shown elevated levels of alcohol misuse and psychological distress among these refugees. The World Health Organization (WHO) has developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM +) to reduce psychological distress among populations exposed to adversities. Our study aims to evaluate the effectiveness and cost-effectiveness of the CHANGE intervention, which builds on PM + , to also address alcohol misuse through problem-solving therapy and selected behavioural strategies for dealing with alcohol use disorders. We hypothesise that the CHANGE intervention together with enhanced usual care (EUC) will be superior to EUC alone in increasing the percentage of days abstinent. Methods A parallel-arm individually randomised controlled trial will be conducted in the Rhino Camp and Imvepi settlements in Uganda. Five hundred adult male South Sudanese refugees with (i) elevated levels of alcohol use (between 8 and 20 on the Alcohol Use Disorder Identification Test [AUDIT]); and (ii) psychological distress (> 16 on the Kessler Psychological Distress Scale) will be randomly assigned 1:1 to EUC or CHANGE and EUC. CHANGE will be delivered by lay healthcare providers over 6 weeks. Outcomes will be assessed at 3 and 12 months post-randomisation. The primary outcome is the percentage of days abstinent, measured by the timeline follow-back measure at 3 months. Secondary outcomes include percentage of days abstinent at 12 months and alcohol misuse (measured by the AUDIT), psychological distress (i.e. depression, anxiety, posttraumatic stress disorder), functional disability, perpetration of intimate partner violence, and health economic indicators at 3 and 12 months. A mixed-methods process evaluation will investigate competency, dose, fidelity, feasibil, Background: The war in South Sudan has displaced more than four million people, with Uganda hosting the largest number of South Sudanese refugees. Research in Uganda has shown elevated levels of alcohol misuse and psychological distress among these refugees. The World Health Organization (WHO) has developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM +) to reduce psychological distress among populations exposed to adversities. Our study aims to evaluate the effectiveness and cost-effectiveness of the CHANGE intervention, which builds on PM +, to also address alcohol misuse through problem-solving therapy and selected behavioural strategies for dealing with alcohol use disorders. We hypothesise that the CHANGE intervention together with enhanced usual care (EUC) will be superior to EUC alone in increasing the percentage of days abstinent. Methods: A parallel-arm individually randomised controlled trial will be conducted in the Rhino Camp and Imvepi settlements in Uganda. Five hundred adult male South Sudanese refugees with (i) elevated levels of alcohol use (between 8 and 20 on the Alcohol Use Disorder Identification Test [AUDIT]); and (ii) psychological distress (> 16 on the Kessler Psychological Distress Scale) will be randomly assigned 1:1 to EUC or CHANGE and EUC. CHANGE will be delivered by lay healthcare providers over 6 weeks. Outcomes will be assessed at 3 and 12 months post-randomisation. The primary outcome is the percentage of days abstinent, measured by the timeline follow-back measure at 3 months. Secondary outcomes include percentage of days abstinent at 12 months and alcohol misuse (measured by the AUDIT), psychological distress (i.e. depression, anxiety, posttraumatic stress disorder), functional disability, perpetration of intimate partner violence, and health economic indicators at 3 and 12 months. A mixed-methods process evaluation will investigate competency, dose, fidelity, feasibility, and acce

Background The war in South Sudan has displaced more than four million people, with Uganda hosting the largest number of South Sudanese refugees. Research in Uganda has shown elevated levels of alcohol misuse and psychological distress among these refugees. The World Health Organization (WHO) has developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM +) to reduce psychological distress among populations exposed to adversities. Our study aims to evaluate the effectiveness and cost-effectiveness of the CHANGE intervention, which builds on PM + , to also address alcohol misuse through problem-solving therapy and selected behavioural strategies for dealing with alcohol use disorders. We hypothesise that the CHANGE intervention together with enhanced usual care (EUC) will be superior to EUC alone in increasing the percentage of days abstinent. Methods A parallel-arm individually randomised controlled trial will be conducted in the Rhino Camp and Imvepi settlements in Uganda. Five hundred adult male South Sudanese refugees with (i) elevated levels of alcohol use (between 8 and 20 on the Alcohol Use Disorder Identification Test [AUDIT]); and (ii) psychological distress (> 16 on the Kessler Psychological Distress Scale) will be randomly assigned 1:1 to EUC or CHANGE and EUC. CHANGE will be delivered by lay healthcare providers over 6 weeks. Outcomes will be assessed at 3 and 12 months post-randomisation. The primary outcome is the percentage of days abstinent, measured by the timeline follow-back measure at 3 months. Secondary outcomes include percentage of days abstinent at 12 months and alcohol misuse (measured by the AUDIT), psychological distress (i.e. depression, anxiety, posttraumatic stress disorder), functional disability, perpetration of intimate partner violence, and health economic indicators at 3 and 12 months. A mixed-methods process evaluation will investigate competency, dose, fidelity, feasibil, Background: The war in South Sudan has displaced more than four million people, with Uganda hosting the largest number of South Sudanese refugees. Research in Uganda has shown elevated levels of alcohol misuse and psychological distress among these refugees. The World Health Organization (WHO) has developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM +) to reduce psychological distress among populations exposed to adversities. Our study aims to evaluate the effectiveness and cost-effectiveness of the CHANGE intervention, which builds on PM +, to also address alcohol misuse through problem-solving therapy and selected behavioural strategies for dealing with alcohol use disorders. We hypothesise that the CHANGE intervention together with enhanced usual care (EUC) will be superior to EUC alone in increasing the percentage of days abstinent. Methods: A parallel-arm individually randomised controlled trial will be conducted in the Rhino Camp and Imvepi settlements in Uganda. Five hundred adult male South Sudanese refugees with (i) elevated levels of alcohol use (between 8 and 20 on the Alcohol Use Disorder Identification Test [AUDIT]); and (ii) psychological distress (> 16 on the Kessler Psychological Distress Scale) will be randomly assigned 1:1 to EUC or CHANGE and EUC. CHANGE will be delivered by lay healthcare providers over 6 weeks. Outcomes will be assessed at 3 and 12 months post-randomisation. The primary outcome is the percentage of days abstinent, measured by the timeline follow-back measure at 3 months. Secondary outcomes include percentage of days abstinent at 12 months and alcohol misuse (measured by the AUDIT), psychological distress (i.e. depression, anxiety, posttraumatic stress disorder), functional disability, perpetration of intimate partner violence, and health economic indicators at 3 and 12 months. A mixed-methods process evaluation will investigate competency, dose, fidelity, feasibility, and acce

Background: Living with and managing atrial fibrillation (AF) can be complex. Some people have no symptoms, while others have a significant symptom burden. Health-related quality of life (HRQoL) is often low and partly associated with symptom burden. However, the impact of the condition on daily life differs between those affected and is not fully understood. Therefore, more knowledge is needed about patients’ experiences of AF and factors influencing HRQoL. Research indicates that the care of patients with AF needs to change and be more based on personal preferences and values. Aim: The overall aim of this thesis was to explore patients’ experiences of AF and to evaluate the effects of a nurse-led, person-centred clinic. Methods: The thesis contains four studies. Study I was based on interviews with 15 patients about their experiences of living with symptomatic AF. Studies II and III were based on data from questionnaires completed before and 6 months after scheduled electrical cardioversion. Study II was a cross-sectional study with 52 women and 115 men describing illness perceptions and HRQoL and exploring their relationship. Study III was a longitudinal study comparing 53 newly diagnosed (<6 months) and 76 previously diagnosed patients with AF (≥6 months) regarding HRQoL, illness perceptions, symptoms, symptom burden, anxiety and depression. Study IV was a randomised controlled trial evaluating the effects of a nurse-led, person-centred clinic on patient-reported outcomes measures in patients with AF. Patients were randomly assigned to a nurse-led intervention group (n=50) or a control group with a physician visit (n=53) and completed questionnaires on the same subjects as in Study III at baseline before the visit to the clinic and 6 months after. Study I were analysed with qualitative content analysis. The other studies are quantitative and were analysed with descriptive statistics (Studies II–IV), comparative statistics (Studies II–IV), and correlation anal

In the last decades, Housing First model has become a feasible alternative to the traditional “staircase” systems in caring for the most vulnerable homeless people. The analysis that we present in this work is referred to Hábitat, a pioneering HF programme in Spain, which has been evaluated attending to both costs and outcomes. A randomised controlled trial was carried out and the collected data was explored through a Cost‐Effectiveness Analysis (CEA), including the estimation of Incremental Cost‐Effectiveness Ratios (ICER) and acceptability thresholds of the programme's spending. The results highlight the capacity of the programme to significantly improve the participants' life satisfaction levels, reduce the number of homeless nights, and increase the rate of institutional coverage. Even though the programme involves significant short‐term expenditure on accommodation, positive effects in net terms are demonstrated supporting the usefulness and viability of HF model., Depto. de Economía Aplicada, Pública y Política, Fac. de Ciencias Políticas y Sociología, TRUE, pub

Background and purpose This study explored the feasibility and acceptability of conducting a larger trial of a self-guided, online self-compassion and acceptance and commitment therapy (ACT) focused treatment among people with type 2 diabetes (T2D) to decrease psychological distress. Materials and methods This study was a two-arm, parallel, feasibility randomised controlled trial with nested qualitative methods. UK adults with T2D were randomly (1:1) allocated to a five-week online self-compassion and ACT treatment or waitlist control. Information regarding recruitment, trial retention, and treatment completion was collected, and post-treatment semi-structured interviews were conducted to assess feasibility and acceptability. Self-report measures of psychological distress (depression, anxiety, diabetes distress) and potential treatment processes (self-compassion and psychological flexibility) were completed as secondary feasibility outcomes. Results Fifty-five (60.44 %) out of 91 people who accessed the study link were eligible to participate. Of these, 33 eligible participants (60 %) were randomly assigned to treatment (n = 19) or control arms (waitlist; n = 14). While treatment completion was 47.37 %, trial retention rates were 39.39 % (5-week follow-up) and 21.2 % (9-week follow-up). Secondary feasibility outcomes of treatment effect estimates are difficult to interpret in light of low treatment completion and trial retention rates. Conclusion A larger trial of the self-guided, online self-compassion treatment to decrease psychological distress in people with T2D may be beneficial, but it has limited feasibility in its current form. Further efforts are needed to improve treatment acceptability of online self-compassion and ACT focused treatment and trial procedures.

Background and purpose This study explored the feasibility and acceptability of conducting a larger trial of a self-guided, online self-compassion and acceptance and commitment therapy (ACT) focused treatment among people with type 2 diabetes (T2D) to decrease psychological distress. Materials and methods This study was a two-arm, parallel, feasibility randomised controlled trial with nested qualitative methods. UK adults with T2D were randomly (1:1) allocated to a five-week online self-compassion and ACT treatment or waitlist control. Information regarding recruitment, trial retention, and treatment completion was collected, and post-treatment semi-structured interviews were conducted to assess feasibility and acceptability. Self-report measures of psychological distress (depression, anxiety, diabetes distress) and potential treatment processes (self-compassion and psychological flexibility) were completed as secondary feasibility outcomes. Results Fifty-five (60.44 %) out of 91 people who accessed the study link were eligible to participate. Of these, 33 eligible participants (60 %) were randomly assigned to treatment (n = 19) or control arms (waitlist; n = 14). While treatment completion was 47.37 %, trial retention rates were 39.39 % (5-week follow-up) and 21.2 % (9-week follow-up). Secondary feasibility outcomes of treatment effect estimates are difficult to interpret in light of low treatment completion and trial retention rates. Conclusion A larger trial of the self-guided, online self-compassion treatment to decrease psychological distress in people with T2D may be beneficial, but it has limited feasibility in its current form. Further efforts are needed to improve treatment acceptability of online self-compassion and ACT focused treatment and trial procedures.

Background and purpose This study explored the feasibility and acceptability of conducting a larger trial of a self-guided, online self-compassion and acceptance and commitment therapy (ACT) focused treatment among people with type 2 diabetes (T2D) to decrease psychological distress. Materials and methods This study was a two-arm, parallel, feasibility randomised controlled trial with nested qualitative methods. UK adults with T2D were randomly (1:1) allocated to a five-week online self-compassion and ACT treatment or waitlist control. Information regarding recruitment, trial retention, and treatment completion was collected, and post-treatment semi-structured interviews were conducted to assess feasibility and acceptability. Self-report measures of psychological distress (depression, anxiety, diabetes distress) and potential treatment processes (self-compassion and psychological flexibility) were completed as secondary feasibility outcomes. Results Fifty-five (60.44 %) out of 91 people who accessed the study link were eligible to participate. Of these, 33 eligible participants (60 %) were randomly assigned to treatment (n = 19) or control arms (waitlist; n = 14). While treatment completion was 47.37 %, trial retention rates were 39.39 % (5-week follow-up) and 21.2 % (9-week follow-up). Secondary feasibility outcomes of treatment effect estimates are difficult to interpret in light of low treatment completion and trial retention rates. Conclusion A larger trial of the self-guided, online self-compassion treatment to decrease psychological distress in people with T2D may be beneficial, but it has limited feasibility in its current form. Further efforts are needed to improve treatment acceptability of online self-compassion and ACT focused treatment and trial procedures.

Background and purpose This study explored the feasibility and acceptability of conducting a larger trial of a self-guided, online self-compassion and acceptance and commitment therapy (ACT) focused treatment among people with type 2 diabetes (T2D) to decrease psychological distress. Materials and methods This study was a two-arm, parallel, feasibility randomised controlled trial with nested qualitative methods. UK adults with T2D were randomly (1:1) allocated to a five-week online self-compassion and ACT treatment or waitlist control. Information regarding recruitment, trial retention, and treatment completion was collected, and post-treatment semi-structured interviews were conducted to assess feasibility and acceptability. Self-report measures of psychological distress (depression, anxiety, diabetes distress) and potential treatment processes (self-compassion and psychological flexibility) were completed as secondary feasibility outcomes. Results Fifty-five (60.44 %) out of 91 people who accessed the study link were eligible to participate. Of these, 33 eligible participants (60 %) were randomly assigned to treatment (n = 19) or control arms (waitlist; n = 14). While treatment completion was 47.37 %, trial retention rates were 39.39 % (5-week follow-up) and 21.2 % (9-week follow-up). Secondary feasibility outcomes of treatment effect estimates are difficult to interpret in light of low treatment completion and trial retention rates. Conclusion A larger trial of the self-guided, online self-compassion treatment to decrease psychological distress in people with T2D may be beneficial, but it has limited feasibility in its current form. Further efforts are needed to improve treatment acceptability of online self-compassion and ACT focused treatment and trial procedures.

BACKGROUND: Cost-effective treatments are needed to reduce the burden of depression. One way to improve the cost-effectiveness of psychotherapy might be to increase session frequency, but keep the total number of sessions constant.AIM: To evaluate the cost-effectiveness of twice-weekly compared with once-weekly psychotherapy sessions after 12 months, from a societal perspective.METHOD: An economic evaluation was conducted alongside a randomised controlled trial comparing twice-weekly versus once-weekly sessions of psychotherapy (cognitive-behavioural therapy or interpersonal psychotherapy) for depression. Missing data were handled by multiple imputation. Statistical uncertainty was estimated with bootstrapping and presented with cost-effectiveness acceptability curves.RESULTS: Differences between the two groups in depressive symptoms, physical and social functioning, and quality-adjusted life-years (QALY) at 12-month follow-up were small and not statistically significant. Total societal costs in the twice-weekly session group were higher, albeit not statistically significantly so, than in the once-weekly session group (mean difference €2065, 95% CI -686 to 5146). The probability that twice-weekly sessions are cost-effective compared with once-weekly sessions was 0.40 at a ceiling ratio of €1000 per point improvement in Beck Depression Inventory-II score, 0.32 at a ceiling ratio of €50 000 per QALY gained, 0.23 at a ceiling ratio of €1000 per point improvement in physical functioning score and 0.62 at a ceiling ratio of €1000 per point improvement in social functioning score.CONCLUSIONS: Based on the current results, twice-weekly sessions of psychotherapy for depression are not cost-effective over the long term compared with once-weekly sessions.

Aim The LeoDOR trial explored the efficacy and safety of intermittent levosimendan therapy in the vulnerable phase following a hospitalization for acute heart failure (HF) Methods and results In this prospective multicentre, double-blind, two-armed trial, patients with advanced HF were randomized 2:1 at the end of an index hospitalization for acute HF to intermittent levosimendan therapy or matching placebo for 12weeks. All patients had left ventricular ejection fraction (LVEF) =30% during index hospitalization. Levosimendan was administered according to centre preference either as 6 h infusion at a rate of 0.2 mu g/kg/min every 2weeks, or as 24 h infusion at a rate of 0.1 mu g/kg/min every 3weeks. The primary efficacy assessment after 14weeks was based on a global rank score consisting of three hierarchical groups. Secondary clinical endpoints included the composite risk of tiers 1 and 2 at 14 and 26weeks, respectively. Due to the COVID-19 pandemic, the planned number of patients could not be recruited. The final modified intention-to-treat analysis included 145 patients (93 in the combined levosimendan arm, 52 in the placebo arm), which reduced the statistical power to detect a 20% risk reduction in the primary endpoint to 60%. Compared with placebo, intermittent levosimendan had no significant effect on the primary endpoint: the mean rank score was 72.55 for the levosimendan group versus 73.81 for the placebo group (p= 0.863). However, there was a signal towards a higher incidence of the individual clinical components of the primary endpoint in the levosimendan group versus the placebo group both after 14weeks (hazard ratio [HR] 2.94, 95% confidence interval [CI] 1.12- 7.68; p= 0.021) and 26weeks (HR 1.64, 95% CI 0.87- 3.11; p= 0.122). Among patients recently hospitalized with HF and reduced LVEF, intermittent levosimendan therapy did not improve post-hospitalization clinical stability. [GRAPHICS.]

Childbirth can be associated with both positive and negative psychological reactions. The experience of labour and birth is subjective, multidimensional and complex including physiological and psychological factors. Distress from a negative birth experience can lead to various psychiatric disorders, such as postpartum depression and post-traumatic stress disorder following childbirth (PTSD FC) which both can have extensive consequences for the woman and her family members. The overall aim of this thesis was to develop and evaluate internet-based cognitive behaviour therapy (iCBT) compared to Treatment as usual (TAU) for women with negative birth experiences at risk for PTSD FC. The work is summarized in four papers originating from one randomised controlled trial (RCT). Paper I presents the study protocol of the RCT. Paper II investigated predictors for non-participation, pre-treatment dropout, treatment dropout and loss to follow-up in the RCT. Paper III and IV evaluated the effect of iCBT on mental health and quality of life (paper III) and partner relationship and mother-infant bonding (paper IV). Results from paper II showed that a majority of the eligible women never participated and those with no obstetric complications were more likely to not participate and/or dropout at different time points. Nonparticipation was predicted by several variables, both demographic, antepartum and obstetrical. Results from paper III showed that ICBT did not reduce PTSD FC or depressive symptoms and in paper IV we found that iCBT had no effect on different aspects of partner relationship or mother-infant bonding. However, both groups (ICBT and TAU) reported reductions of re-experiences of traumatic memories and depressive symptoms over time. Both groups also reported fewer positive feelings and attitudes toward their partner over time and mother-infant bonding showed initial improvement, but this later changed into decline over time. In summary, we could not demonstrate any

Use of surrogate end-points such as progression-free survival (PFS) and other time-to-event (TTE) end-points is common in multiple myeloma (MM) clinical trials. This systematic review characterises all published randomised controlled trials (RCTs) in MM using PFS or other TTE end-points between 2005 and 2019 and assesses strength of surrogacy of PFS for overall survival (OS). The association between OS hazard ratios (HRs) and PFS HRs was evaluated with linear regression, and the coefficient of determination with Pearson's correlation. We identified 88 RCTs of which 67 (76%) used PFS as the primary/co-primary end-point. One trial indicated whether progression was biochemical or clinical. Of the variance in OS, 39% was due to variance in PFS. Correlation between PFS and OS was weak (0.62, 95% confidence interval [CI] 0.38–0.78). In newly diagnosed MM, 43% of the variance in OS was due to changes in PFS. The correlation between PFS and OS was weak (0.65, 95% CI 0.30–0.84). In relapsed/refractory MM, 58% of the variance in OS was due to changes in PFS. Correlation between PFS and OS was medium (0.76, 95% CI 0.42–0.91). We demonstrate that PFS and progression characteristics are characterised poorly in MM trials and that PFS is a poor surrogate for OS in MM., First published online: 10 December 2022

Objectives: Reduced progression of atherosclerosis can decrease the risk of cardiovascular disease (CVD). This study aimed at evaluating the effect of a pictorial intervention showing atherosclerotic severity on the progression of carotid atherosclerosis. Methods: A prospective randomised open-label blinded end-point trial with participants aged 40–60 years enroled from a routine CVD prevention programme. The intervention group (n: 1575) and their treating physicians received an image based presentation of subclinical atherosclerotic severity measured by carotid ultrasound. The control group (n: 1579) did not receive any information about ultrasound results. Carotid ultrasound at baseline and at 3-year follow-up contained plaque detection and measurements of carotid intima media thickness (cIMT). The left, right and bilateral-mean-cIMT, plaque prevalence and total plaque area (TPA) at 3-year follow-up were compared between groups. Significance level was set to p = 0.01 to adjust for multiple comparisons. Results: The intervention group revealed reduced cIMT progression in the left-mean-cIMT of −0.011 mm (p = 0.001) compared with the control group. The intervention effect on cIMT progression was most prominent in individuals with increased cIMT and plaque prevalence at baseline (−0.021 mm, p = 0.005). There were no differences in progression between groups for the right-and bilateral-mean-cIMT (−0.005 mm, p = 0.223 and −0.005 mm, p = 0.036, respectively), nor any differences between groups for plaque prevalence or TPA (odds ratio 0.88, p = 0.09 and 0.89, p = 0.21, respectively). Conclusion: Pictorial presentation of subclinical atherosclerotic severity sent to both the individual and their treating physician resulted in significantly reduced left cIMT progression. Pictorial presentation has the potential to increase adherence in CVD prevention.

Use of surrogate end-points such as progression-free survival (PFS) and other time-to-event (TTE) end-points is common in multiple myeloma (MM) clinical trials. This systematic review characterises all published randomised controlled trials (RCTs) in MM using PFS or other TTE end-points between 2005 and 2019 and assesses strength of surrogacy of PFS for overall survival (OS). The association between OS hazard ratios (HRs) and PFS HRs was evaluated with linear regression, and the coefficient of determination with Pearson's correlation. We identified 88 RCTs of which 67 (76%) used PFS as the primary/co-primary end-point. One trial indicated whether progression was biochemical or clinical. Of the variance in OS, 39% was due to variance in PFS. Correlation between PFS and OS was weak (0.62, 95% confidence interval [CI] 0.38–0.78). In newly diagnosed MM, 43% of the variance in OS was due to changes in PFS. The correlation between PFS and OS was weak (0.65, 95% CI 0.30–0.84). In relapsed/refractory MM, 58% of the variance in OS was due to changes in PFS. Correlation between PFS and OS was medium (0.76, 95% CI 0.42–0.91). We demonstrate that PFS and progression characteristics are characterised poorly in MM trials and that PFS is a poor surrogate for OS in MM., First published online: 10 December 2022

Objectives: Reduced progression of atherosclerosis can decrease the risk of cardiovascular disease (CVD). This study aimed at evaluating the effect of a pictorial intervention showing atherosclerotic severity on the progression of carotid atherosclerosis. Methods: A prospective randomised open-label blinded end-point trial with participants aged 40–60 years enroled from a routine CVD prevention programme. The intervention group (n: 1575) and their treating physicians received an image based presentation of subclinical atherosclerotic severity measured by carotid ultrasound. The control group (n: 1579) did not receive any information about ultrasound results. Carotid ultrasound at baseline and at 3-year follow-up contained plaque detection and measurements of carotid intima media thickness (cIMT). The left, right and bilateral-mean-cIMT, plaque prevalence and total plaque area (TPA) at 3-year follow-up were compared between groups. Significance level was set to p = 0.01 to adjust for multiple comparisons. Results: The intervention group revealed reduced cIMT progression in the left-mean-cIMT of −0.011 mm (p = 0.001) compared with the control group. The intervention effect on cIMT progression was most prominent in individuals with increased cIMT and plaque prevalence at baseline (−0.021 mm, p = 0.005). There were no differences in progression between groups for the right-and bilateral-mean-cIMT (−0.005 mm, p = 0.223 and −0.005 mm, p = 0.036, respectively), nor any differences between groups for plaque prevalence or TPA (odds ratio 0.88, p = 0.09 and 0.89, p = 0.21, respectively). Conclusion: Pictorial presentation of subclinical atherosclerotic severity sent to both the individual and their treating physician resulted in significantly reduced left cIMT progression. Pictorial presentation has the potential to increase adherence in CVD prevention.

Use of surrogate end-points such as progression-free survival (PFS) and other time-to-event (TTE) end-points is common in multiple myeloma (MM) clinical trials. This systematic review characterises all published randomised controlled trials (RCTs) in MM using PFS or other TTE end-points between 2005 and 2019 and assesses strength of surrogacy of PFS for overall survival (OS). The association between OS hazard ratios (HRs) and PFS HRs was evaluated with linear regression, and the coefficient of determination with Pearson's correlation. We identified 88 RCTs of which 67 (76%) used PFS as the primary/co-primary end-point. One trial indicated whether progression was biochemical or clinical. Of the variance in OS, 39% was due to variance in PFS. Correlation between PFS and OS was weak (0.62, 95% confidence interval [CI] 0.38–0.78). In newly diagnosed MM, 43% of the variance in OS was due to changes in PFS. The correlation between PFS and OS was weak (0.65, 95% CI 0.30–0.84). In relapsed/refractory MM, 58% of the variance in OS was due to changes in PFS. Correlation between PFS and OS was medium (0.76, 95% CI 0.42–0.91). We demonstrate that PFS and progression characteristics are characterised poorly in MM trials and that PFS is a poor surrogate for OS in MM., First published online: 10 December 2022

Objectives: Reduced progression of atherosclerosis can decrease the risk of cardiovascular disease (CVD). This study aimed at evaluating the effect of a pictorial intervention showing atherosclerotic severity on the progression of carotid atherosclerosis. Methods: A prospective randomised open-label blinded end-point trial with participants aged 40–60 years enroled from a routine CVD prevention programme. The intervention group (n: 1575) and their treating physicians received an image based presentation of subclinical atherosclerotic severity measured by carotid ultrasound. The control group (n: 1579) did not receive any information about ultrasound results. Carotid ultrasound at baseline and at 3-year follow-up contained plaque detection and measurements of carotid intima media thickness (cIMT). The left, right and bilateral-mean-cIMT, plaque prevalence and total plaque area (TPA) at 3-year follow-up were compared between groups. Significance level was set to p = 0.01 to adjust for multiple comparisons. Results: The intervention group revealed reduced cIMT progression in the left-mean-cIMT of −0.011 mm (p = 0.001) compared with the control group. The intervention effect on cIMT progression was most prominent in individuals with increased cIMT and plaque prevalence at baseline (−0.021 mm, p = 0.005). There were no differences in progression between groups for the right-and bilateral-mean-cIMT (−0.005 mm, p = 0.223 and −0.005 mm, p = 0.036, respectively), nor any differences between groups for plaque prevalence or TPA (odds ratio 0.88, p = 0.09 and 0.89, p = 0.21, respectively). Conclusion: Pictorial presentation of subclinical atherosclerotic severity sent to both the individual and their treating physician resulted in significantly reduced left cIMT progression. Pictorial presentation has the potential to increase adherence in CVD prevention.

Childbirth can be associated with both positive and negative psychological reactions. The experience of labour and birth is subjective, multidimensional and complex including physiological and psychological factors. Distress from a negative birth experience can lead to various psychiatric disorders, such as postpartum depression and post-traumatic stress disorder following childbirth (PTSD FC) which both can have extensive consequences for the woman and her family members. The overall aim of this thesis was to develop and evaluate internet-based cognitive behaviour therapy (iCBT) compared to Treatment as usual (TAU) for women with negative birth experiences at risk for PTSD FC. The work is summarized in four papers originating from one randomised controlled trial (RCT). Paper I presents the study protocol of the RCT. Paper II investigated predictors for non-participation, pre-treatment dropout, treatment dropout and loss to follow-up in the RCT. Paper III and IV evaluated the effect of iCBT on mental health and quality of life (paper III) and partner relationship and mother-infant bonding (paper IV). Results from paper II showed that a majority of the eligible women never participated and those with no obstetric complications were more likely to not participate and/or dropout at different time points. Nonparticipation was predicted by several variables, both demographic, antepartum and obstetrical. Results from paper III showed that ICBT did not reduce PTSD FC or depressive symptoms and in paper IV we found that iCBT had no effect on different aspects of partner relationship or mother-infant bonding. However, both groups (ICBT and TAU) reported reductions of re-experiences of traumatic memories and depressive symptoms over time. Both groups also reported fewer positive feelings and attitudes toward their partner over time and mother-infant bonding showed initial improvement, but this later changed into decline over time. In summary, we could not demonstrate any

IntroductionThe COVID-19 pandemic has required a shift of many routine primary care visits to telemedicine, potentially widening disparities in care access among vulnerable populations. In a publicly-funded HIV clinic, we aimed to evaluate a pre-visit phone-based planning intervention to address anticipated barriers to telemedicine.MethodsWe conducted a pragmatic randomized controlled trial of patients scheduled for a phone-based HIV primary care visit at the Ward 86 HIV clinic in San Francisco from 15 April to 15 May 2020. Once reached by phone, patients were randomized to either have a structured pre-visit planning intervention to address barriers to an upcoming telemedicine visit versus a standard reminder call. The primary outcome was telemedicine visit attendance.ResultsOf 476 scheduled telemedicine visits, 280 patients were reached by a pre-visit call to offer enrollment. Patients were less likely to be reached if virally unsuppressed (odds ratio (OR) 0.11, 95% confidence intervals (CI) 0.03-0.48), CD4 < 200 (OR 0.24, 95% CI 0.07-0.85), or were homeless (OR 0.24, 95% CI 0.07-0.87). There was no difference between intervention and control in scheduled visit attendance (83% v. 78%, OR 1.38, 95% CI 0.67-2.81).ConclusionsA structured phone-based planning call to address barriers to telemedicine in a public HIV clinic was less likely to reach patients with poorly-controlled HIV and patients experiencing homelessness, suggesting additional interventions may be needed in this population to ensure access to telemedicine-based care. Among patients reachable by phone, telemedicine visit attendance was high and not improved with a structured pre-visit intervention, suggesting that standard reminders may be adequate in this population.

Background Migraine is a common and distressing neurological condition characterised by recurrent throbbing headaches, nausea and heightened sensitivity to light and sound. Accumulating evidence suggests that cerebral arteries dilate during migraine, causing distal microvessels to constrict, which could activate nociceptors and cause onset of headache pain. If so, preventing or attenuating chronic microvascular constriction, and promoting a dilatory phenotype, may reduce frequency and/or severity of migraines. The primary aim of the L-Arginine and Aged Garlic Extract (LARGE) trial is to investigate whether oral treatment with dietary nutraceuticals, L-arginine and aged garlic extract (AGE), both systemic vasodilatory agents, will alleviate migraine frequency, duration and severity in adults with chronic frequent episodic migraines. Methods The study is a randomised double-blind placebo-controlled phase-II single-site clinical trial conducted in Perth, Australia. The target sample is to recruit 240 participants diagnosed with chronic frequent episodic migraines between 18 and 80 years of age. Participants will be randomised to one of four treatment groups for 14 weeks (placebo induction for 2 weeks, followed by 12 weeks on one of the respective treatment arms): placebo, L-arginine, AGE, or a combination of L-arginine and AGE. The doses of L-arginine and AGE are 1.5 g and 1 g daily, respectively. The primary outcome is to assess migraine response using change in migraine frequency and intensity between baseline and 12 weeks. Secondary outcomes include the impact of L-arginine and/or AGE on photosensitivity, retinal vessel changes, and blood biomarker concentrations of vascular tone, following a 12-week intervention. Discussion The protocol describes the oral administration of 2 nutraceutical-based interventions as possible prophylactic treatments for chronic frequent episodic migraines, with potential for direct clinical translation of outcomes. Potential limitations

Retention of participants, therefore reducing missing data, in randomised controlled trials (RCTs) is one of the most important issues currently concerning clinical trialists. There are several research projects which are investigating retention in clinical trials, however none of these projects are specifically exploring retention in paediatric trials. Analyses of RCTs are often carried assuming that the probability of being missing only depends on the observed data (Missing At Random, MAR), but sensitivity analyses using statistical methods that allow the assumption that the missingness is related to the actual value of the missing observation (Missing Not At Random, MNAR) are rarely carried out, although advised. In this thesis, I begin by conducting a systematic review of retention of participants to reporting the primary outcome in paediatric RCTs published between January 2015 to December 2019 within six high impact-factor journals. I conduct meta-regressions of trial and participant factors which may be associated with retention to the primary outcome. I conduct a systematic review and narrative synthesis of qualitative studies exploring participant retention in paediatric trials, and a qualitative study exploring clinical trialists experience of conducting paediatric RCTS. I review methods which are suitable for sensitivity analyses to the MAR assumption for normally-distributed missing outcome data in RCTs. In a simulation study, I compare the Mean Score, Delta-shift after multiple imputation, Selection Model with inverse probability weighting and Stacked multiple imputation methods. I apply these to a trial data example, the Bristol Girls Dance Project. I conclude with a discussion and suggestions for future research.

Background and purpose This study explored the feasibility and acceptability of conducting a larger trial of a self-guided, online self-compassion and acceptance and commitment therapy (ACT) focused treatment among people with type 2 diabetes (T2D) to decrease psychological distress. Materials and methods This study was a two-arm, parallel, feasibility randomised controlled trial with nested qualitative methods. UK adults with T2D were randomly (1:1) allocated to a five-week online self-compassion and ACT treatment or waitlist control. Information regarding recruitment, trial retention, and treatment completion was collected, and post-treatment semi-structured interviews were conducted to assess feasibility and acceptability. Self-report measures of psychological distress (depression, anxiety, diabetes distress) and potential treatment processes (self-compassion and psychological flexibility) were completed as secondary feasibility outcomes. Results Fifty-five (60.44 %) out of 91 people who accessed the study link were eligible to participate. Of these, 33 eligible participants (60 %) were randomly assigned to treatment (n = 19) or control arms (waitlist; n = 14). While treatment completion was 47.37 %, trial retention rates were 39.39 % (5-week follow-up) and 21.2 % (9-week follow-up). Secondary feasibility outcomes of treatment effect estimates are difficult to interpret in light of low treatment completion and trial retention rates. Conclusion A larger trial of the self-guided, online self-compassion treatment to decrease psychological distress in people with T2D may be beneficial, but it has limited feasibility in its current form. Further efforts are needed to improve treatment acceptability of online self-compassion and ACT focused treatment and trial procedures.