This study aimed to examine how older adults form beliefs about their memory and how these beliefs are influenced by their level of concern about dementia. Inaccurate beliefs and excessive worrying, indicative of erroneous metacognition, are associated with negative health outcomes. This research can help identify mitigation for these harmful effects.

Qualitative focus groups; thematic analysis.

Focus group discussion with healthy older adults hosted at a university in central London.

35 healthy older individuals (women=29) without any psychiatric or neurological diagnoses, over the age of 65 years (mean 75.31, SD: 6.15). 13 participants were identified as having a high level of worry about dementia and 22 as having low worry. Groups were matched for cognitive performance on the Telephone Mini Addenbrooke’s cognitive assessment (Tele-MACE).

Participants were assigned to a focus group depending on their level of worry about dementia. During focus groups, a vignette prompted discussion around lifespan changes in memory and how this affected concerns around memory. This allowed investigation of the differences in beliefs about memory.

Thematic analysis revealed two key themes. First, older adults appear to base their definition of ‘normality’ of their own memory on comparisons. These comparisons were between themselves and others and between themselves now and their own past self. Despite similar strategies to define ‘normality’, those with high dementia worry had stricter definitions of what they determined as normal. The second theme described narratives around the ‘self’ and the ‘other’. There was a difference between those with high versus low worry; those with high worry had a strong focus on the ‘self’, while those with low dementia worry focused on ‘others’.

Comparison is a common metacognitive strategy used in forming beliefs about memory. Targeting the use of comparison is potentially valuable in interventions aiming to alleviate older adults’ memory concerns. Addressing self-focused thinking, for example, with cognitive behavioural therapy, could improve harmful levels of high worry.

Type 2 diabetes mellitus (T2DM) and osteoarthritis (OA) are globally prevalent chronic diseases that affect millions of individuals in ageing populations. Hip and knee replacements are well established and effective treatments in patients suffering from end-stage OA. Understanding how T2DM influences the outcomes of these surgeries is important for optimising patient care and improving surgical results. This study aimed to explore the association of T2DM with reoperation (regardless of the reason), adverse events (AEs) and mortality after primary hip and knee replacement surgery.

Observational study based on prospectively collected registry data analysed retrospectively.

Data from several Swedish national quality registers and health data registers were used to create a study database. 109 938 and 80 897 primary hip and knee replacements due to OA, performed between 2008 and 2019 (hip) and 2009 and 2018 (knee), were included in the study.

The risk of complications, such as reoperation, AEs and mortality, was investigated by estimating HRs using Cox regression, and OR using logistic regression, unadjusted and adjusted for confounding factors, such as patient characteristics, socioeconomic status and comorbidities, and mediators, such as surgical factors.

Adjusted multivariable Cox-regression analysis showed no T2DM-associated risk of reoperation after hip or knee replacement, adjusted HR 1.10 (95% CI 0.99 to 1.23) and 1.09 (95% CI 0.96 to 1.24), respectively, while T2DM was associated with increased risk of death after hip and knee replacement, adjusted HR 1.40 (95% CI 1.34 to 1.47) and 1.38 (95% CI 1.31 to 1.45). Adjusted logistic regression analysis showed T2DM-associated increase of reoperation within 90 days (OR 1.23 (95% CI 1.05 to 1.43)) and increased mortality within 90 days (OR 1.42 (95% CI 1.01 to 1.95)) following hip replacement; however, this was not the case after knee replacement, OR 1.08 (95% CI 0.85 to 1.36) for reoperation and OR 1.29 (95% CI 0.84 to 1.94) for mortality. Several factors closely linked with T2DM, such as body-mass index and comorbidities, were identified as important when assessing risk of reoperation and mortality. Regarding AEs within 30 and 90 days, very slight but not statistically significant T2DM-associated increases were seen after either hip replacement, OR 1.01 (95% CI 0.91 to 1.11) and 1.07 (95% CI 0.98 to 1.16) or after knee replacement, OR 1.05 (95% CI 0.93 to 1.17) and 1.08 (95% CI 0.98 to 1.19).

The observed risk of reoperation suggests that T2DM alone was not a strong justification to advise against hip or knee replacement in individuals with T2DM deemed eligible for joint replacement. The T2DM-associated increased mortality after hip and knee replacement is challenging to interpret, as T2DM itself without undergoing hip or knee replacement surgery is associated with increased mortality.

The Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART) study is a prospective cohort study aiming to explore health outcomes in mothers and children following assisted reproductive technology (ART), with a particular focus on frozen embryo transfer (FET) versus fresh embryo transfer (fresh-ET). The increasing prevalence of ART and FET emphasises the need to assess potential health risks associated with the procedures, both in pregnancy, such as pre-eclampsia and large for gestational age offspring, and in the children, such as obesity and cardiometabolic dysfunction.

The cohort will include 600 pregnant women, their potential partner and their offspring in a 1:1:1 ratio of pregnancies achieved after ART with FET, ART with fresh-ET and women who conceived naturally. The study will involve extensive data collection from electronic medical records; parental questionnaires; biochemical, genetic and epigenetic analyses in blood, urine and placental tissue; and medical imaging (fetal ultrasound and PEA POD scan) and clinical examinations. Outcomes are grouped into six work packages (WPs) related to fetal growth (WP1), pregnancy (WP2), placenta (WP3), offspring (WP4), genetics (WP5) and epigenetics (WP6).

The COMPART study aims to provide valuable insights into the impact of ART and FET on maternal and offspring health and the underlying mechanisms responsible. The study seeks to advance reproductive medicine, shape clinical practice and guidelines and ultimately ensure maternal-fetal health following ART. The study has been approved by the Danish Ethics Committee (H-23071266; February 2024).

NCT06334003

Fathers of preterm infants wish to be actively involved and attentive in caring for their children. The positive impacts of paternal caregiving on preterm infants’ cognitive and social development have been recognised. Awareness of the need to support fathers during early parenthood is increasing, but fathers may feel excluded when their infants are in the neonatal intensive care unit. Here, we present the protocol for a study involving the development and national implementation of a complex intervention supporting first-time fathers of preterm infants in early parenthood.

The study adheres to the Medical Research Council framework for complex interventions. A multicentre, prospective, non-blinded, quasi-experimental design will be applied to evaluate the effect of a clinical and technology-based intervention targeting both nurses and the fathers. Outcomes from participants enrolled during the control (2023–2024) and intervention (2025–2026) periods, comprising 295 fathers and their partners, will be compared. Effects on parental confidence, stress, depression and mood and family and reflective functioning as well as infants’ emotional and social development will be assessed. A comprehensive process evaluation will be applied using both qualitative and quantitative methods.

The study has been registered at Clinicaltrials.org [no. NCT0 6 116 747 (The SUPPORTED study – First-time Fathers of Preterm Infants), approved on 3 November 2023]. The Danish Data Protection Agency has approved the study (P-2022–792). The findings will be disseminated through peer-reviewed publications.

NCT06116747.

Communication is a professional competence that all paediatric healthcare professionals must learn and maintain to provide age and developmentally appropriate care. Child-centred communication encourages direct communication with children and adolescents, incorporating the use of play as a communicative strategy. Still, many paediatric healthcare professionals receive little or no formal training in communication and play. A critical barrier to communication training is the limited possibilities for healthcare professionals to take time from their clinical duties. Moreover, few randomised controlled trials have evaluated educational programmes on communication and play for paediatric healthcare professionals, and existing programmes vary significantly in design and duration. This study aims to compare the effects of a 45-min and a 3-hour educational intervention for healthcare professionals on age-appropriate communication and the use of play in clinical paediatric practice.

We will describe a single-centre, randomised, controlled, two-arm, non-inferiority trial. We will recruit 150 healthcare professionals with different professional backgrounds who will be randomised to one of two arms: a 45-min or 3-hour educational intervention on communication and play in paediatric clinical practice. The primary outcome will be their self-efficacy in patient-centredness at 12-week post-intervention, while secondary outcomes will be self-efficacy immediately after the intervention, motivation to engage in the educational activity, cognitive load, self-evaluated knowledge, satisfaction and the impact on individual practice and training needs. Data will be collected through questionnaires at baseline, immediately after the intervention, and 12 weeks post-intervention and will be analysed using linear mixed models with random effects to account for clustering and within-subject correlation.

The Danish Data Protection Agency approved the study (P-2020–1144), which will be conducted in accordance with the Declaration of Helsinki. Findings will be published in a peer-reviewed open-access scientific journal and presented at international conferences.

NCT06859632 (ClinicalTrials.gov).

Physicians frame medical information for patients in different ways, impacting patient outcomes. What underlies their framing choices has not been investigated. 

To explore the use and function of information framing practices in medical interactions.

Explorative, quantitative observational study with a mixed-methods design.

28 videorecorded hospital interactions, ranging from short-term/acute (orthopaedic surgery, gynaecology) to long-term/chronic care (oncology, gastroenterology) and involving 14 physicians and 28 patients.

Using a previously developed coding system, we analysed physicians’ framing practices. We extracted information sharing functions qualitatively, checking 10% of the analysis with an independent assessment from the physicians. To explore whether variation in physicians’ use of information frames stemmed from individual or clinical specialty differences, we estimated intraclass correlations. To assess how their use of information frames varied at the macro level (across clinical specialties) and micro (the immediate function in the interaction), we estimated linear mixed models adjusted for the number of words.

Variation in framing practices was mainly observed at the level of physicians nested within the same clinical unit (9.5% of the overall variance explained vs 1.3% for the unit level and 0.7% for the individual level). Physicians from different clinical units differed significantly in how they framed information, with the main differences between the gastroenterology and oncology units (mean difference=1.88; 95% CI 0.97; 2.79; p2 tests). Physicians from more short-term care units were oriented towards shared understanding, from gastroenterology towards inviting and convincing efforts and from oncology towards personal communication.

Results revealed signature marks of clinical units in terms of information sharing practices. Physicians’ information framing choices were driven both by the macro level (the clinical unit) and micro (the specific function for sharing information at that moment), thus highlighting potential areas for future interventions.

To map, summarise and analyse the methodologies of corneal nerve fibre imaging in studies using in vivo confocal microscopy (IVCM) in diabetes and assess the potential for standardising methods and reporting.

A scoping review was conducted using five databases, MEDLINE, Embase, Cochrane, Web of Science and Scopus, with search terms related to IVCM, diabetes and corneal nerves. Two researchers independently screened the studies for eligibility. Relevant data were extracted and systematically analysed.

Out of 1533 screened articles, 195 met the inclusion criteria. Spanning from 2000 to 2024, the studies showed high variability in image acquisition, image processing, image analysis and reporting detail. Most studies used laser scanning confocal microscopy, examining the central cornea in both eyes in patients with type 2 diabetes, manually selecting 3–6 images from each eye, and using ACCMetrics and CCMetrics for quantifying corneal nerve fibre length in mm/mm². Many studies lacked sufficient methodological details for reproducibility.

IVCM studies of corneal nerve fibres in diabetes show substantial methodological heterogeneity and inconsistent reporting, limiting reproducibility. We propose a guideline to support standardisation and improve the reliability of future research.

Treatment of the two billion people with tuberculosis (TB) infection worldwide is crucial to prevent progression to TB disease and thereby prevent further transmission. However, TB is associated with fear and stigma, and knowledge gaps about TB disease are widespread, complicating adherence to treatment. As increasing knowledge about TB can reduce stigma and increase adherence to treatment, we developed an educational film about TB infection and disease. After showing the film to people with TB, our qualitative study aimed to evaluate the film and to explore perceptions, fears and possible knowledge gaps.

We conducted a qualitative study, with in-depth interviews (n=13), at two Infectious Disease Outpatient Departments in Sweden. Included research participants were adults with TB infection or TB disease. After informed consent, the participants watched the film, available in Swedish, English, Somali and Tigrinya. Subsequently, in-depth interviews, using a topic guide, were conducted, transcribed, and a reflexive thematic analysis was performed.

All participants considered the film to be a valuable addition to the written and oral information they had previously received. Identified themes included the perception of TB infection being a deadly, non-curable disease, and many feared being contagious. However, the film challenged these fears and increased the understanding of TB infection being treatable and non-infectious. Another theme revealed that TB-related stigma was experienced in encounters with healthcare professionals in Sweden.

Our educational film was perceived to increase understanding about TB symptoms, transmission and treatment. Implementing the film in Infectious Disease Departments across Sweden may contribute to decreasing stigma and enhancing awareness of the importance of treatment adherence, an outcome that warrants further investigation post-implementation.

Time-lapse imaging (TLI) systems for embryo incubation and assessment are hypothesised to improve the success rates of in vitro fertilisation (IVF) treatment by providing undisturbed culture conditions for embryos and/or providing more information on embryo development (morphokinetic parameters) to improve predictive accuracy for embryo selection. Despite numerous aggregate meta-analyses showing uncertainty of benefit, IVF clinics globally continue to invest significant resources into this technology with little translation of evidence into guidelines or policy frameworks. This may be attributed to heterogeneity in participant populations and/or variations in the use of TLI, as highlighted in the aggregate meta-analyses.

Our research proposal for evidence synthesis using individual participant data meta-analysis will provide greater power than aggregate meta-analysis to detect differential treatment effects for effectiveness (live birth, clinical pregnancy) and safety (pregnancy loss, multiple births, congenital malformations) outcomes across three comparisons (overall effect, undisturbed culture and morphokinetic parameters). We will also analyse if there are specific subgroups of women who may benefit from the intervention and if variations in use of the intervention show any benefits. We have incorporated the results of the literature search used for the latest Cochrane review (7 January 2019) into this review and will include all the trials included therein. We will further update the literature search to include new evidence by searching the electronic databases MEDLINE, EMBASE, CINAHL and CENTRAL from 07/01/2019 to date, outcomes for all ongoing trials reported in the 2019 Cochrane review, trial registers for newer ongoing/completed trials and the citation lists of all the newly identified trials for any relevant references. The search strategy will include a combination of subject headings and text words relating to or describing the participants and the intervention, with no language restrictions. Two authors will independently screen the titles and abstracts, and full text of articles retrieved from the search, to finalise a list of trials suitable for inclusion in the review. We will include randomised controlled trials that assess TLI systems for either undisturbed culture and/or use of morphokinetic parameters for embryo selection in women having IVF/ICSI treatment using their own oocytes.

Ethical approval is not required for this study. We plan to disseminate the findings of the research to all stakeholders, including the National Institute for Health and Care Excellence and other international guideline development groups, through publication in peer-reviewed journals, presentation at conferences, newsletters, meetings and websites of the funders, fertility charities and patient support groups.

CRD42024564332.

The use of direct oral anticoagulants (DOACs) as stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF) has increased steadily since the introduction in 2011. In Sweden today, more patients are treated with DOACs than with warfarin. However, it is not shown that an increased proportion of DOAC prescriptions correlates to lower event rates of stroke and systemic embolism.

This study aims to investigate whether the increased prescription of DOACs in Sweden correlates with lower event rates for all-cause stroke, systemic embolism and bleeding complications, using real-life data for the whole NVAF population.

Nationwide retrospective register study.

Data were obtained from the Swedish National Patient Registry, covering patients aged 18 years or older with NVAF, between 1 January 2014, and 31 December 2017. Exposure to oral anticoagulants was determined based on pharmaceutical data, calculating treatment duration by the number of pills dispensed and the prescribed daily usage rate. Baseline characteristics and endpoints were collected from hospital administrative registers using International Classification of Diseases, 10th edition (ICD-10) codes.

All patients with NVAF were identified using ICD-10 codes during the study period. Entry criteria included having a first recorded atrial fibrillation diagnosis after 1 January 2014 or being previously diagnosed with atrial fibrillation before 2014 but still receiving care after this date.

The outcomes were event rates (per 100 person-years) of ischaemic stroke, systemic embolism, all-cause stroke, major bleeding and intracranial bleeding (including haemorrhagic stroke). Event rates were calculated and compared across the study period using Cox proportional hazard models.

In the total NVAF population, the proportional decrease in event rates (per 100 treatment years) in 2017 compared with 2014 was ischaemic stroke 24% (1.70–1.30), all-cause mortality 4% (9.40–9.00), all-cause stroke 24% (2.10–1.60) and all-cause stroke and systemic embolism 23% (2.20–1.70). During the same time, the proportion of major bleeding and intracranial bleeding rates, including haemorrhagic stroke, also decreased: 5% (2.00–1.90), 6% (0.68–0.64) and 17% (0.30–0.25), respectively. DOACs use increased from 4.1% to 28.3% in the total population and from 22.7% to 60.9% in newly diagnosed patients.

In the initial years following the introduction when DOAC uptake in the population was high, an increasing proportion of Swedish NVAF patients receiving DOACs was accompanied by lower event rates of all-cause stroke and systemic embolism, ischaemic stroke and all-cause mortality, intracranial bleeding and major bleeding, highlighting the improved risk-benefit balance of DOACs in stroke prophylaxis.

Alcohol consumption that damages health remains highly prevalent in Sweden despite macrolevel intervention measures such as availability, restrictions and taxation. As understanding of behaviour change develops, there may be an opportunity to enhance individual level interventions by targeting personal dimensions of behaviour, such as underlying motives for drinking alcohol and readiness to change behaviour. This protocol describes a randomised controlled trial aimed at estimating the effectiveness of an intervention tailored to motives and readiness to change.

A three-arm, parallel groups, randomised controlled trial will be used to estimate the effects of a motives and readiness to change tailored intervention. We will use a Bayesian sequential design to decide when to stop recruitment, with target criteria for benefit, harm and futility. Recruitment will be completed via web adverts and social media. Inclusion criteria are being aged 18 or older, having access to a mobile phone and being classified as a risky drinker. Participants allocated to the two intervention groups will receive either a personalised digital intervention or an intervention with enhanced tailoring for motives and readiness to change. The personalised intervention consists of weekly screening, personalised feedback and tools for planning behaviour. The enhanced tailored version will follow the same logic but will contain materials tailored for individuals’ drinking motives and readiness to change. The control group will be redirected to two national websites with information about alcohol and health. Outcome measures are weekly alcohol consumption and monthly heavy drinking episodes, which will be contrasted with regression models and estimated using Bayesian inference.

Ethical approval was obtained from the Swedish Ethical Review Authority on 16 April 2024, (Dnr 2024-01630-01). The results of the study will be disseminated in academic journals and research conferences.

The trial was preregistered in the ISRCTN Registry on 12 June 2024 (ISRCTN87600318).

Despite an increasing amount of research related to gender-affirming treatment (GAT) outcomes among transgender and gender-diverse (TGD) people (ie, people who experience discomfort or distress in the misalignment between their gender and sex assigned at birth) in recent years, the evidence base for current recommendations is suboptimal. One contributing factor is the heterogeneity in the outcomes and outcome measures used. This study seeks to address this challenge by developing a foundational core outcome set (COS) to be used for TGD adults receiving GAT in Sweden.

Recommendations from the Core Outcome Measures in Effectiveness Trials initiative will be used to address this aim in four phases. Phase 1, an umbrella review of peer-reviewed literature and international guidelines in GAT will be conducted to identify relevant outcomes. In phase 2, we will solicit input from TGD individuals through the review of patient and interest organisations’ reports and an anonymous survey to identify outcomes of personal significance. In phase 3, using the Delphi method, 2–3 rounds of assessment will be conducted where researchers, healthcare professionals, policy-makers and TGD adults rate the identified outcomes by perceived importance. In phase 4, a consensus meeting will convene representatives from all stakeholder groups to finalise the COS.

The results of this study will consist of a COS for GAT regarding TGD adults in Sweden. Participant survey responses will be evaluated using interpretive analysis to identify core outcomes. During each of the Delphi rounds, Likert-type scale ratings will be aggregated for outcomes to advance or be eliminated in each round.

The study has received ethical approval by the Swedish Ethical Review Authority (Umeå medicine department, Registration number: 2024-04672-01). The results of this study will be published open-access and disseminated through TGD interest organisations and a Swedish research network for gender dysphoria.

COMET registration number 3223.