To Örebro University

OBJECTIVE: Colon cancer surgery remains associated with substantial postoperative morbidity and mortality despite advances in surgical techniques and care. The trauma of surgery triggers adrenergic hyperactivation which drives adverse stress responses. We hypothesised that outcome benefits are gained by reducing the effects of hyperadrenergic activity with beta-blocker therapy in patients undergoing colon cancer surgery. This study aims to test this hypothesis.

DESIGN: Retrospective cohort study.

SETTING AND PARTICIPANTS: This is a nationwide study which includes all adult patients undergoing elective colon cancer surgery in Sweden over 10 years. Patient data were collected from the Swedish Colorectal Cancer Registry. The national drugs registry was used to obtain information about beta-blocker use. Patients were subdivided into exposed and unexposed groups. The association between beta-blockade, short-term and long-term mortality was evaluated using Poisson regression, Kaplan-Meier curves and Cox regression.

PRIMARY AND SECONDARY OUTCOMES: Primary outcome of interest was 1-year all-cause mortality. Secondary outcomes included 90-day all-cause and 5-year cancer-specific mortality.

RESULTS: The study included 22 337 patients of whom 36.1% were prescribed preoperative beta-blockers. Survival was higher in patients on beta-blockers up to 1 year after surgery despite this group being significantly older and of higher comorbidity. Regression analysis demonstrated significant reductions in 90-day deaths (IRR 0.29, 95% CI 0.24 to 0.35, p<0.001) and a 43% risk reduction in 1-year all-cause mortality (adjusted HR 0.57, 95% CI 0.52 to 0.63, p<0.001) in beta-blocked patients. In addition, cancer-specific mortality up to 5 years after surgery was reduced in beta-blocked patients (adjusted HR 0.80, 95% CI 0.73 to 0.88, p<0.001).

CONCLUSION: Preoperative beta-blockade is associated with significant reductions in postoperative short-term and long-term mortality following elective colon cancer surgery. Its potential prophylactic effect warrants further interventional studies to determine whether beta-blockade can be used as a way of improving outcomes for this patient group.

Purpose: To present the Uppsala Longitudinal Adolescent Depression Study, initiated in Uppsala, Sweden, in the early 1990s. The initial aim of this epidemiological investigation was to study the prevalence, characteristics and correlates of adolescent depression, and has subsequently expanded to include a broad range of social, economic and health-related long-term outcomes and cost-of-illness analyses.

Participants: The source population was first-year students (aged 16-17) in upper-secondary schools in Uppsala during 1991-1992, of which 2300 (93%) were screened for depression. Adolescents with positive screening and sex/age-matched peers were invited to a comprehensive assessment. A total of 631 adolescents (78% females) completed this assessment, and 409 subsequently completed a 15year follow-up assessment. At both occasions, extensive information was collected on mental disorders, personality and psychosocial situation. Detailed social, economic and health-related data from 1993 onwards have recently been obtained from the Swedish national registries for 576 of the original participants and an age-matched reference population (N=200 000).

Findings to date: The adolescent lifetime prevalence of a major depressive episode was estimated to be 11.4%. Recurrence in young adulthood was reported by the majority, with a particularly poor prognosis for those with a persistent depressive disorder or multiple somatic symptoms. Adolescent depression was also associated with an increased risk of other adversities in adulthood, including additional mental health conditions, low educational attainment and problems related to intimate relationships.

Future plans: Longitudinal studies of adolescent depression are rare and must be responsibly managed and utilised. We therefore intend to follow the cohort continuously by means of registries. Currently, the participants are approaching mid-adulthood. At this stage, we are focusing on the overall long-term burden of adolescent depression. For this purpose, the research group has incorporated expertise in health economics. We would also welcome extended collaboration with researchers managing similar datasets.

Introduction: Separation after preterm birth is a major stressor for infants and parents. Skin-to-skin contact (SSC) is a method of care suitable to use in the neonatal intensive care unit (NICU) to minimise separation between parents and infants. Less separation leads to increased possibilities for parent-infant interaction, provided that the parents' sleep quality is satisfactory. We aimed to evaluate the effect of continuous SSC on sleep quality and mood in parents of preterm infants born <33 weeks of gestation as well as the quality of parent-infant interaction and salivary cortisol concentrations at the time of discharge.

Methods and analysis: A randomised intervention study with two arms-intervention versus standard care. Data will be collected from 50 families. Eligible families will be randomly allocated to intervention or standard care when transferred from the intensive care room to the family-room in the NICU. The intervention consists of continuous SSC for four consecutive days and nights in the family-room. Data will be collected every day during the intervention and again at the time of discharge from the hospital. Outcome measures comprise activity tracker (Actigraph); validated self-rated questionnaires concerning sleep, mood and bonding; observed scorings of parental sensitivity and emotional availability and salivary cortisol. Data will be analysed with pairwise, repeated measures, Mann Whitney U-test will be used to compare groups and analysis of variance will be used to adjust for different hospitals and parents' gender.

Ethics and dissemination: The study is approved by the Regional Research Ethics Board at an appropriate university (2016/89-31). The results will be published in scientific journals. We will also use conferences and social media to disseminate our findings.

INTRODUCTION: Chronic pain affects about 20%-40% of the population and is linked to mental health outcomes and impaired daily functioning. Pharmacological interventions are commonly insufficient for producing relief and recovery of functioning. Behavioural health treatment is key to generate lasting benefits across outcome domains. However, most people with chronic pain cannot easily access evidence-based behavioural interventions. The overall aim of the DAHLIA project is to develop, evaluate and implement a widely accessible digital behavioural health treatment to improve well-being in individuals with chronic pain.

METHODS AND ANALYSIS: The project follows the four phases of the mHealth Agile Development and Evaluation Lifecycle: (1) development and pre-implementation surveillance using focus groups, stakeholder interviews and a business model; (2) iterative optimisation studies applying single case experimental design (SCED) method in 4-6 iterations with n=10 patients and their healthcare professionals per iteration; (3) a two-armed clinical randomised controlled trial enhanced with SCED (n=180 patients per arm) and (4) interview-based post-market surveillance. Data analyses include multilevel modelling, cost-utility and indicative analyses.In October 2021, inter-sectorial partners are engaged and funding is secured for four years. The treatment content is compiled and the first treatment prototype is in preparation. Clinical sites in three Swedish regions are informed and recruitment for phase 1 will start in autumn 2021. To facilitate long-term impact and accessibility, the treatment will be integrated into a Swedish health platform (www.1177.se), which is used on a national level as a hub for advice, information, guidance and e-services for health and healthcare.

ETHICS AND DISSEMINATION: The study plan has been reviewed and approved by Swedish ethical review authorities. Findings will be actively disseminated through peer-reviewed journals, conference presentations, social media and outreach activities for the wider public.

TRIAL REGISTRATION NUMBER: NCT05066087.

Objectives Dynamic ambulance relocation means that the operators at a dispatch centre place an ambulance in a temporary location, with the goal of optimising coverage and response times in future medical emergencies. This study aimed to scope the current research on dynamic ambulance relocation.

Design A scoping review was conducted using a structured search in PubMed, Scopus and Web of Science. In total, 21 papers were included.

Results Most papers described research with experimental designs involving the use of mathematical models to calculate the optimal use and temporary relocations of ambulances. The models relied on several variables, including distances, locations of hospitals, demographic-geological data, estimation of new emergencies, emergency medical services (EMSs) working hours and other data. Some studies used historic ambulance dispatching data to develop models. Only one study reported a prospective, real-time evaluation of the models and the development of technical systems. No study reported on either positive or negative patient outcomes or real-life chain effects from the dynamic relocation of ambulances.

Conclusions Current knowledge on dynamic relocation of ambulances is dominated by mathematical and technical support data that have calculated optimal locations of ambulance services based on response times and not patient outcomes. Conversely, knowledge of how patient outcomes and the working environment are affected by dynamic ambulance dispatching is lacking. This review has highlighted several gaps in the scientific coverage of the topic. The primary concern is the lack of studies reporting on patient outcomes, and the limited knowledge regarding several key factors, including the optimal use of ambulances in rural areas, turnaround times, domino effects and aspects of working environment for EMS personnel. Therefore, addressing these knowledge gaps is important in future studies.

OBJECTIVES: To evaluate symptoms presented by the caller during emergency calls regarding stroke, and to assess if symptoms in the Face-Arm-Speech-Time Test (FAST) are related to identification of stroke.

SETTING: Emergency calls to the Emergency Medical Communication Center (EMCC) concerning patients discharged with stroke diagnosis in a large teaching hospital in Stockholm, Sweden, in January-June 2011.

PARTICIPANTS: The emergency calls of 179 patients who arrived at hospital by ambulance, and who were discharged with a stroke diagnosis and consented to participate were included in the study.

OUTCOME MEASURES: Frequencies of stroke symptoms presented and a comparison of symptoms presented in calls with dispatch code stroke or other dispatch code.

RESULTS: Of the 179 emergency calls analysed, 64% were dispatched as 'Stroke'. FAST symptoms, that is, facial or arm weakness or speech disturbances, were presented in 64% of the calls and were spontaneously revealed in 90%. Speech disturbance was the most common problem (54%) in all calls, followed by fall/lying position (38%) and altered mental status (27%). For patients with dispatch codes other than stroke, the dominating problem presented was a fall or being in a lying position (66%), followed by speech disturbance (31%) and altered mental status (25%). Stroke-specific symptoms were more common in patients dispatched as stroke. FAST symptoms were reported in 80% of patients dispatched as stroke compared with 35% in those dispatched as something else.

CONCLUSIONS: This study implicates that fall/lying position and altered mental status could be considered as possible symptoms of stroke during an emergency call. Checking for FAST symptoms in these patients might uncover stroke symptoms. Future studies are needed to evaluate if actively asking for FAST symptoms in emergency calls presenting falls or a lying position can improve the identification of stroke.

TRIAL REGISTRATION NUMBER: Stroke2010/703-31/2.

Introduction: Worldwide, an estimated 40 million people are in need of palliative care each year, but only 14% receive it. The incidence of diabetes mellitus (DM) in patients receiving palliative care is higher than in the general population. This association is intended to grow as a result of the rising burden of DM worldwide, ageing populations and the improved overall survival time of several diseases over the last few decades. Recommendations for DM management in the context of palliative care are mainly based on expert opinion as there is a lack of suitable evidence base and randomised clinical trials in palliative care are scarce. The aim of our systematic review is to identify the best DM management practices in order to reduce important DM-related symptoms and acute complications in patients receiving palliative care.

Methods and analysis: The authors will study the DM treatment and management literature, surveying the different approaches employed to treat adult palliative patients. Core health bibliographic databases will be searched from January 1990 to May 2019. Data sources will include Ovid MEDLINE, Embase, PubMed, Web of Sciences, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Scopus, Cumulative Index to Nursing and Allied Health Literature and grey literature. Details regarding diet, oral and injectable glucose-lowering medicines, insulin regimens and blood glucose monitoring strategies will he evaluated. We defined the primary outcomes to compare between DM management approaches as the presence of symptoms (polyuria, polydipsia and polyphagia) and acute complications of DM (hypoglycaemia, hyperglycaemic hyperosmolar state and diabetic ketoacidosis), and secondary outcomes as hospital admissions and deaths due to DM-related complications, health-related quality of life and glycaemic control.

Ethics and dissemination: The systematic review methodology does not require ethics approval due to the nature of the study design. The results of the systematic review will be published in a peer-reviewed journal and will he publicly available.

PROSPERO registration number: CRD42018115772.

INTRODUCTION: Iron-deficiency anaemia is common in gynaecological oncology patients. Blood transfusions are immunosuppressive and carry immediate and long-term risks. Oral iron replacement remains the standard of care but requires prolonged treatment courses associated with gastrointestinal side effects, poor compliance and variable absorption in cancer patients. Intravenous iron has been shown to decrease the need for allogeneic blood transfusion in gynaecological oncology patients undergoing chemotherapy, but the efficacy of this treatment in the preoperative period is unknown. The goal of this pilot study is to determine the effect of intravenous ferric derisomaltose on preoperative haemoglobin in patients undergoing surgery for gynaecological malignancy.

METHODS AND ANALYSIS: We will conduct a pilot single-centre, parallel-arm randomised controlled trial of intravenous ferric derisomaltose versus placebo among consenting patients with iron-deficiency anaemia having elective major surgery on the gynaecological oncology service. Patients, clinicians and outcome assessors will be blinded. The intervention consists of a single infusion of 500-1000 mg of intravenous ferric derisomaltose administered a minimum of 21 days prior to the planned operation. The primary outcome is mean preoperative haemoglobin concentration measured 0-3 days prior to surgery in patients receiving intravenous ferric derisomaltose compared with those receiving placebo. Secondary outcomes include the following: change in haemoglobin concentration, postoperative haemoglobin concentration, perioperative blood transfusion rates, patient-reported quality of life scores (Quality of Recovery 15, Modified Short Form 36 v1, EuroQol 5-dimension 5-level and Functional Assessment of Cancer Therapy - Anaemia), surgical site infection, complication rates, length of hospital stay and readmission rate. Analyses will follow intention-to-treat principles for all randomised participants. All patients will be followed up to 60 days following surgery.

ETHICS AND DISSEMINATION: Ethical approval has been granted by Health Research Ethics Board of Alberta (Project ID: HREBA.CC-22-0187) and Health Canada (HC6-024-c264013). Results will be disseminated through presentation at scientific conferences, peer-reviewed publication and social and traditional media.

TRIAL REGISTRATION NUMBER: NCT05407987.

Objectives: Social Autopsy (SA) is an innovative strategy where a trained facilitator leads community groups through a structured, standardised analysis of the physical, environmental, cultural and social factors contributing to a serious, non-fatal health event or death. The discussion stimulated by the formal process of SA determines the causes and suggests preventative measures that are appropriate and achievable in the community. Here we explored individual experiences of SA, including acceptance and participant learning, and its effect on rural communities in Bangladesh. The present study had explored the experiences gained while undertaking SA of maternal and neonatal deaths and stillbirths in rural Bangladesh.

Design: Qualitative assessment of documents, observations, focus group discussions, group discussions and in-depth interviews by content and thematic analyses.

Results: Each community's maternal and neonatal death was a unique, sad story. SA undertaken by government field-level health workers were well accepted by rural communities. SA had the capability to explore the social reasons behind the medical cause of the death without apportioning blame to any individual or group. SA was a useful instrument to raise awareness and encourage community responses to errors within the society that contributed to the death. People participating in SA showed commitment to future preventative measures and devised their own solutions for the future prevention of maternal and neonatal deaths.

Conclusions: SA highlights societal errors and promotes discussion around maternal or newborn death. SA is an effective means to deliver important preventative messages and to sensitise the community to death issues. Importantly, the community itself is enabled to devise future strategies to avert future maternal and neonatal deaths in Bangladesh.

Objectives: To use simple measures of laterality and hand control that can identify a greater risk of poorer scholastic ability, potentially signalling suboptimal hemispheric lateralisation.

Design: Analysis of material from a birth cohort study.

Setting: Members of the National Child Development Study, a British birth cohort study following people born in 1958.

Participants: 10 612 children who undertook tests at age 11 years.

Primary outcome measures: Teacher-administered tests of non-verbal general ability, verbal general ability, reading comprehension and mathematics.

Results: Linear regression produced associations (and 95% CIs) with tests of verbal general ability, non-verbal general ability, reading comprehension and mathematics scores for the lowest third (compared with highest) of a left-hand control test involving picking up matches of -1.21 (-1.73 to -0.68; p<0.001), -0.72 (-1.14 to -0.29; p=0.001), -0.70 (-1.06 to -0.35; p<0.001) and -1.32 (-1.90 to -0.73; p<0.001). Among those in the lowest third of the right-hand control test score, mixed-handedness compared with right-handedness was associated with poorer scholastic performance, with regression coefficients (and 95% CIs; p values) of 1.90 (-3.01 to -0.80; p=0.001), -1.25 (-2.15 to -0.35; p=0.007), -1.28 (2.04 to -0.53; p=0.001) and -1.33 (-2.53 to -0.13; p=0.030). The estimates are for a point change in the scholastic test scores, after adjustment for sex, left-hand motor function and social class. Statistically significant associations with mixed-handedness were only observed for the lowest third of right-hand motor function.

Conclusions: Measures involving poorer left-hand motor function may represent useful markers of reduced cognitive function possibly reflecting suboptimal hemispheric lateralisation. Crude measures of laterality such as reported non-right-handedness may be more useful for research when combined with measures of motor function.

OBJECTIVES: To explore health problems and the recovery process after being deployed in a major incident.

DESIGN: Qualitative, explorative design.

SETTING: Ambulance services in Sweden.

PARTICIPANTS AND METHODS: Semistructured, individual two-session interviews with 15 ambulance nurses with the experience of being deployed to major incidents were conducted. Data were analysed with thematic analysis.

RESULTS: Being deployed in major incidents was perceived to be straining and led to both physical health problems and distress. To recover, the ambulance nurses strived to use strategies to distance themselves from the situation and created supportive conditions for their recovery, and if successful, the experiences led to both professional and personal growth and self-awareness. However, being deployed in major incidents without significant preparedness or experience could harm individuals and, in the worst case, end their career.

CONCLUSIONS: A successful recovery from the physical and mental exhaustion experienced after being deployed in a major incident required both individual abilities and self-care strategies as well as a supportive working environment. Supporting individual recovery strategies and following up on physical and mental well-being over time should be part of all ambulance services procedures after major incidents.

OBJECTIVES: Congenital hemiplegia is the most common form of cerebral palsy (CP). Children with unilateral CP show signs of upper limb asymmetry by 8 months corrected age (ca) but are frequently not referred to therapy until after 12 months ca. This study compares the efficacy of infant-friendly modified constraint-induced movement therapy (Baby mCIMT) to infant friendly bimanual therapy (Baby BIM) on upper limb, cognitive and neuroplasticity outcomes in a multisite randomised comparison trial.

METHODS AND ANALYSIS: 150 infants (75 in each group), aged between 3 and 6 months ca, with asymmetric brain injury and clinical signs of upper extremity asymmetry will be recruited. Children will be randomised centrally to receive equal doses of either Baby mCIMT or Baby BIM. Baby mCIMT comprises restraint of the unimpaired hand using a simple restraint (eg, glove, sock), combined with intensive parent implemented practice focusing on active use of the impaired hand in a play-based context. In contrast, Baby BIM promotes active play requiring both hands in a play-based context. Both interventions will be delivered by parents at home with monthly home visits and interim telecommunication support by study therapists. Assessments will be conducted at study entry; at 6, 12 months ca immediately postintervention (primary outcome) and 24 months ca (retention). The primary outcome will be the Mini-Assisting Hand Assessment. Secondary outcomes include the Bayley Scale for Infant and Toddler Development (cognitive and motor domains) and the Hand Assessment of Infants. A subset of children will undertake MRI scans at 24 months ca to evaluate brain lesion severity and brain (re)organisation after intervention.

ETHICS AND DISSEMINATION: Full ethical approvals for this study have been obtained from the relevant sites. The findings will be disseminated in peer-reviewed publications.

TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry: ACTRN12615000180516, Pre results.

OBJECTIVE: To assess the efficacy of inhaled ciclesonide in reducing the duration of oxygen therapy (an indicator of time to clinical improvement) among adults hospitalised with COVID-19.

DESIGN: Multicentre, randomised, controlled, open-label trial.

SETTING: 9 hospitals (3 academic hospitals and 6 non-academic hospitals) in Sweden between 1 June 2020 and 17 May 2021.

PARTICIPANTS: Adults hospitalised with COVID-19 and receiving oxygen therapy.

INTERVENTION: Inhaled ciclesonide 320 µg two times a day for 14 days versus standard care.

MAIN OUTCOME MEASURES: Primary outcome was duration of oxygen therapy, an indicator of time to clinical improvement. Key secondary outcome was a composite of invasive mechanical ventilation/death.

RESULTS: Data from 98 participants were analysed (48 receiving ciclesonide and 50 receiving standard care; median (IQR) age, 59.5 (49-67) years; 67 (68%) men). Median (IQR) duration of oxygen therapy was 5.5 (3-9) days in the ciclesonide group and 4 (2-7) days in the standard care group (HR for termination of oxygen therapy 0.73 (95% CI 0.47 to 1.11), with the upper 95% CI being compatible with a 10% relative reduction in oxygen therapy duration, corresponding to a <1 day absolute reduction in a post-hoc calculation). Three participants in each group died/received invasive mechanical ventilation (HR 0.90 (95% CI 0.15 to 5.32)). The trial was discontinued early due to slow enrolment.

CONCLUSIONS: In patients hospitalised with COVID-19 receiving oxygen therapy, this trial ruled out, with 0.95 confidence, a treatment effect of ciclesonide corresponding to more than a 1 day reduction in duration of oxygen therapy. Ciclesonide is unlikely to improve this outcome meaningfully.

TRIAL REGISTRATION NUMBER: NCT04381364.

OBJECTIVES: The introduction of information and communication technology influences the work environment of large groups of employees in healthcare. In Sweden, a national healthcare service providing patient accessible electronic health records (PAEHR) has been deployed, and this paper investigates nurses' expected effects of this implementation.

SETTING: Nurses associated with the Swedish Association of Health Professionals working in healthcare such as primary care, hospitals and midwives in Sweden. Before a full-scale national implementation of PAEHR, a web survey study was distributed nationally. The respondents represented all 21 Swedish regions. Questions included five-point Likert scale questions and open questions.

PARTICIPANTS: A survey link was distributed via email to 8460 registered nurses, midwives and union representatives in Sweden. The response rate was 35.4% (2867 respondents: registered nurses 84%; midwives 6%; chief position 5%; in projects 2% and other 3%). Three reminders were sent out, all of them increasing the response rate. A majority of the respondents were female (89.9%), 8.4% male, whereas 1.7% did not indicate their gender. 31.4% were under 40 years old, 53.8% 40-59 and 13.7% over 60.

RESULTS: Data were analysed using exploratory factor analysis with principal component analysis as the extraction method. The analysis revealed three distinct factors related to nurses' expectations of PAEHR: (1) PAEHR improves the quality of care, (2) PAEHR improves the quality of the work environment and (3) risk and fears concerning patients' well-being. Some interesting results include that more experienced nurses are more favourable to PAEHR. Our analysis also shows that the view of the nurse-patient relationship is an essential underlying factor related to positive or negative expectations.

CONCLUSIONS: Results show that the expectations and perceptions of PAEHR vary depending on the nurse's view of who the electronic record belongs to. Younger nurses are somewhat more negative towards PAEHR than older nurses.

OBJECTIVE: To investigate the influence of demographic and socioeconomic factors on the COVID-19 case-fatality rate (CFR) globally.

DESIGN: Publicly available register-based ecological study.

SETTING: Two hundred and nine countries/territories in the world.

PARTICIPANTS: Aggregated data including 10 445 656 confirmed COVID-19 cases.

PRIMARY AND SECONDARY OUTCOME MEASURES: COVID-19 CFR and crude cause-specific death rate were calculated using country-level data from the Our World in Data website.

RESULTS: The average of country/territory-specific COVID-19 CFR is about 2%-3% worldwide and higher than previously reported at 0.7%-1.3%. A doubling in size of a population is associated with a 0.48% (95% CI 0.25% to 0.70%) increase in COVID-19 CFR, and a doubling in the proportion of female smokers is associated with a 0.55% (95% CI 0.09% to 1.02%) increase in COVID-19 CFR. The open testing policies are associated with a 2.23% (95% CI 0.21% to 4.25%) decrease in CFR. The strictness of anti-COVID-19 measures was not statistically significantly associated with CFR overall, but the higher Stringency Index was associated with higher CFR in higher-income countries with active testing policies (regression coefficient beta=0.14, 95% CI 0.01 to 0.27). Inverse associations were found between cardiovascular disease death rate and diabetes prevalence and CFR.

CONCLUSION: The association between population size and COVID-19 CFR may imply the healthcare strain and lower treatment efficiency in countries with large populations. The observed association between smoking in women and COVID-19 CFR might be due to the finding that the proportion of female smokers reflected broadly the income level of a country. When testing is warranted and healthcare resources are sufficient, strict quarantine and/or lockdown measures might result in excess deaths in underprivileged populations. Spatial dependence and temporal trends in the data should be taken into account in global joint strategy and/or policy making against the COVID-19 pandemic.

Introduction Preterm infants are at risk of negative consequences from stress and pain at the same time as they often are in need of intensive care that includes painful interventions. One of the frequent painful procedures preterm infants undergo is eye examination screening to detect early signs of ROP (retinopathy of prematurity). These examinations are both stressful and painful, and despite a multitude of research studies, no conclusive pain-relieving treatment has been demonstrated. The main aim of this trial is to investigate the analgesic effect of clonidine during ROP eye examinations.

Methods and analysis The planned study is a multicentre randomised controlled trial with a crossover design. Infants will be recruited from two different neonatal intensive care units (NICUs) in Sweden. Infants born before gestation week 30 (and therefore eligible for ROP screening) and cared for in either of the NICUs will be eligible for inclusion in the study. The primary outcome will be Premature Infant Pain Profile–Revised score within 30 s after starting the examination. Secondary outcomes will be changes in the galvanic skin response parameters (area small peaks, area huge peaks, peaks per second and average rise time) within 30 s after starting the eye examination, together with the number and evaluation of adverse events reported within 72 hours after the examination and the examining physician’s assessment of how easy the infant was to examine.

Ethics and dissemination Approval from the Swedish Ethical Review Authority and the Swedish Medical Products Agency has been obtained for the study. Parents of eligible infants will be getting both verbal and written information about the study including that participation is voluntary. Data will be collected and treated in accordance with the European general data protection regulations. The results will be reported on group level and published in a scientific journal.

INTRODUCTION: There is limited knowledge on how the SARS-CoV-2 affects pregnancy outcomes. Studies investigating the impact of COVID-19 in early pregnancy are scarce and information on long-term follow-up is lacking.The purpose of this project is to study the impact of COVID-19 on pregnancy outcomes and long-term maternal and child health by: (1) establishing a database and biobank from pregnant women with COVID-19 and presumably non-infected women and their infants and (2) examining how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19 pandemic.

METHODS AND ANALYSIS: This is a national, multicentre, prospective cohort study involving 27 Swedish maternity units accounting for over 86 000 deliveries/year. Pregnant women are included when they: (1) test positive for SARS-CoV-2 (COVID-19 group) or (2) are non-infected and seek healthcare at one of their routine antenatal visits (screening group). Blood, as well as other biological samples, are collected at different time points during and after pregnancy. Child health up to 4 years of age and parent experience of pregnancy, delivery, early parenthood, healthcare and society in general will be examined using web-based questionnaires based on validated instruments. Short- and long-term health outcomes will be collected from Swedish health registers and the parents' experiences will be studied by performing qualitative interviews.

ETHICS AND DISSEMINATION: Confidentiality aspects such as data encryption and storage comply with the General Data Protection Regulation and with ethical committee requirements. This study has been granted national ethical approval by the Swedish Ethical Review Authority (dnr 2020-02189 and amendments 2020-02848, 2020-05016, 2020-06696 and 2021-00870) and national biobank approval by the Biobank Väst (dnr B2000526:970). Results from the project will be published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER: NCT04433364.

INTRODUCTION: In 2016, WHO estimated there were roughly 374 million new infections among adults of the following four curable sexually transmitted infections (STIs): chlamydia (caused by Chlamydia trachomatis (CT)), gonorrhoea (Neisseria gonorrhoeae (NG)), syphilis (Treponema pallidum) and trichomoniasis (Trichomonas vaginalis (TV)). Accurate point-of-care tests (POCTs) for screening of genital and extragenital CT, NG and TV infections are of great value and have been developed during recent decade. Several tests are commercially available and have shown encouraging performance compared with 'gold-standard' reference tests in laboratory-based studies. However, there is limited data on their clinical performance, including at the POC. Key populations, such as men who have sex with men (MSM), are at higher risk of these STIs at genital and extragenital sites and these STIs are often asymptomatic, especially in extragenital sites and in women. We will conduct a clinical-based evaluation to assess the performance characteristics and acceptability to end-users of molecular-based diagnostic technology for POC/near patient use of the Xpert CT/NG (Cepheid, Sunnyvale, California, USA) test for screening of genital, anorectal and pharyngeal CT and NG infections in MSM and the Xpert CT/NG and Xpert TV (Cepheid, Sunnyvale, California, USA) for screening of genital CT, NG and TV among women at risk for these STIs compared with gold-standard reference nucleic acid amplification tests. This master protocol outlines the overall research approach that will be used in seven countries.

METHOD AND ANALYSES: Consecutive MSM and women at risk presenting at the clinical sites in high, and low- and middle-income countries will be enrolled. The POCTs to be evaluated are Xpert CT/NG and Xpert TV. All procedures will be carried out by trained healthcare staff and tests performed in strict accordance with the manufacturer's instructions. The sensitivity, specificity, positive and negative predictive values for each POCT will be calculated. The study is ongoing with recruitment expected to be completed in all countries by mid-2022 to late-2022.

ETHICS AND DISSEMINATION: Prior to enrolment, this core protocol was independently peer-reviewed and approved by the research project review panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). The core protocol has been slightly adapted accordingly to individual countries and adaptations approved by both RP2 and ERC, as well as all relevant institutional review boards at each participating site. Results will be disseminated through peer-reviewed journals and presented at relevant national/international conferences.

Background: Cardiac rehabilitation (CR) decreases the morbidity and mortality risk among patients with cardiac diseases; however, the impact of CR on patients with diabetes remains underexplored. This is a protocol for a systematic review and meta-analysis methodology to explore if the effect of CR on mortality and morbidity is the same in patients with type 2 diabetes compared with patients without diabetes.

Methods and analysis: Interventional and non-interventional studies comparing the effect of CR, for at least 1 month, on all-cause mortality and cardiovascular outcomes including fatal and non-fatal myocardial infarction, revascularisation and rehospitalisation in adults with cardiac diseases will be deemed eligible for inclusion. Studies published between 1990 and 2020 will be searched in PubMed, Embase, Cochrane, CINAHL, Scopus and in registries for randomised controlled trials. Eligible studies will be selected using the Covidence software, and their salient details regarding the design, population, tested interventions and outcomes of interest will be gathered. The quality of studies to be deemed eligible and reviewed will be assessed using the Cochrane Collaboration and National Heart, Lung, and Blood Institute's tools. The appraisal process will be based on the study design (interventional and non-interventional). In the meta-analysis step, the pooled effect of CR on the outcomes will be estimated. All meta-analyses will be done using the random-effects model approach (inverse-variance method). I-2 and p value of chi(2) statistics will guide the heterogeneity assessment. Subgroup analyses will also be performed. The small study effect will be investigated by generating the funnel plots. The symmetry of the latter will be tested by performing Egger's test.

Ethics and dissemination: The systematic review will use data from published literature; hence, no ethical approval will be required. Findings of the systematic review and meta-analysis will be published in peer-reviewed international journals and will be disseminated in local and international scientific meetings.

PROSPERO registration number: CRD42020148832.

OBJECTIVES: This study psychometrically evaluated General Self-Efficacy (GSE) Scale in patients planned for bariatric surgery in Sweden.

DESIGN: A cross-sectional psychometric study. The psychometric evaluation was guided by the COnsensus-based Standards for the selection of health status Measurement Instruments checklist for health-related reported-patient outcomes.

SETTING: Three bariatric centres in Sweden.

PARTICIPANTS: Adult patients≥18 years old scheduled for primary bariatric surgery (with sleeve gastrectomy or Roux-en-Y gastric bypass).

PRIMARY AND SECONDARY MEASURES: Psychometric properties of the GSE.

RESULTS: In total, 704 patients were included in the analysis. Mean values for GSE items were 2.9-3.4 and the mean GSE sum score was 31.4 (SD 4.7). There were no floor or ceiling effects. Cronbach's alpha was 0.89. Men reported a higher mean GSE than did women, that is, 31.2 (SD 4.8) for women versus 32.1 (SD 4.3) for men, p=0.03. Correlation coefficients were weak or negligible: GSE and mental component summary score of 36-Item Short Form Health Survey (SF-36)/RAND 36, r=0.18 (p<0.00); GSE and physical component summary score of SF-36/RAND 36, r=0.07 (p=0.138); GSE and obesity-related problem scale r=-0.15 (p=0.001) and GSE and level of education, r=0.04 (p=0.35). Confirmatory factor analysis indicated a one-factor construct with a satisfactory goodness of fit, that is, Comparative Fit Index=0.927, root mean square error of approximation=0.092 and standardised root mean square residual=0.045. The factor GSE explained almost half or over half of the variance of each item (0.45-0.75, p-values<0.001).

CONCLUSIONS: The GSE scale is a valid and reliable scale that can be used to assess general self-efficacy in patients undergoing bariatric surgery.

OBJECTIVES: The aim of this study was to explore whether recording in primary care of a previously recorded hospital diagnosis was associated with increased patient utilisation of recommended medications.

DESIGN: Registry-based prospective cohort study.

SETTING AND PARTICIPANTS: 19 072 patients with a hospital discharge diagnosis of transient ischaemic attack (TIA), stroke or acute coronary syndrome from hospitals in Stockholm County 2010-2013 were included in the study.

MAIN OUTCOME MEASURE: The outcome of the study was medication dispensation as a marker of adherence to recommended medications. Adherence was defined as having had at least two filled prescriptions in the third year following hospital discharge.

RESULTS: Recording a diagnosis was associated with higher utilisation of all recommended medications with the exception of antihypertensives in patients with TIA. The differences between the groups with and without a recorded diagnosis remained after adjusting for age, sex, index year and visits to private practitioners. Dispensation of antithrombotics was high overall, 80%-90% in patients without a recorded diagnosis and 90%-94% for those with a diagnosis. Women with recorded ischaemic stroke/TIA/acute coronary syndrome were dispensed more statins (56%-71%) than those with no recorded diagnosis (46%-59%). Similarly, 68%-83% of men with a recorded diagnosis were dispensed statins (57%-77% in men with no recorded diagnosis). The rate of diagnosis recording spanned from 15% to 47% and was especially low in TIA (men 15%, women 16%).

CONCLUSION: Recording a diagnosis of TIA/stroke or acute coronary syndrome in primary care was found to be associated with higher dispensation of recommended secondary preventive medications. Further study is necessary in order to determine the mechanisms underlying our results and to establish the utility of our findings.

Objective: This study aims to examine the associations between microfinance programme membership and intimate partner violence (IPV) in different socioeconomic strata of a nationally representative sample of women in Bangladesh. Methods: The cross-sectional study was based on a nationally representative interview survey of 11 178 ever-married women of reproductive age (15-49 years). A total of 4465 women who answered the IPV-related questions were analysed separately using chi(2) tests and Cramer's V as a measure of effect size to identify the differences in proportions of exposure to IPV with regard to microfinance programme membership, and demographic variables and interactions between microfinance programme membership and factors related to non-economic empowerment were considered. Results: Only 39% of women were members of microfinance programmes. The prevalence of a history of IPV was 48% for moderate physical violence, 16% for severe physical violence and 16% for sexual violence. For women with secondary or higher education, and women at the two wealthiest levels of the wealth index, microfinance programme membership increased the exposure to IPV two and three times, respectively. The least educated and poorest groups showed no change in exposure to IPV associated with microfinance programmes. The educated women who were more equal with their spouses in their family relationships by participating in decision-making increased their exposure to IPV by membership in microfinance programmes. Conclusions: Microfinance plans are associated with an increased exposure to IPV among educated and empowered women in Bangladesh. Microfinance firms should consider providing information about the associations between microfinance and IPV to the women belonging to the risk groups.

INTRODUCTION: Incontinence-associated dermatitis (IAD) is irritant contact dermatitis and skin damage associated with prolonged skin contact with urine and/or faeces. Identifying prognostic factors for the development of IAD may improve management, facilitate prevention and inform future research.

METHODS AND ANALYSIS: This protocol follows the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Prospective and retrospective observational studies or clinical trials in which prognostic factors associated with the development of IAD are described are eligible. There are no restrictions on study setting, time, language, participant characteristics or geographical regions. Reviews, editorials, commentaries, methodological articles, letters to the editor, cross-sectional and case-control studies, and case reports are excluded. MEDLINE, CINAHL, EMBASE and The Cochrane Library will be searched from inception until May 2023. Two independent reviewers will independently evaluate studies. The Quality in Prognostic Studies tool will be used to assess the risk of bias, and the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies-Prognostic Factors checklist will be used for data extraction of the included studies. Separate analyses will be conducted for each identified prognostic factor, with adjusted and unadjusted estimated measures analysed separately. Evidence will be summarised with a meta-analysis when possible, and narratively otherwise. The Q and I2 statistics will be calculated in order to quantify heterogeneity. The quality of the evidence obtained will be evaluated according to the Grades of Recommendation Assessment, Development and Evaluation guidance.

ETHICS AND DISSEMINATION: No ethical approval is needed since all data is already publicly accessible. The results of this work will be published in a peer-reviewed scientific journal.

OBJECTIVES: The aim of this study was to determine the prevalence of infection, genotypes and risk factors for human papillomavirus (HPV) among men who have sex with men (MSM) and transgender women living with and without HIV in Pakistan. Anal infection with HPV is very common worldwide among MSM, particularly among MSM living with HIV. The high prevalence of HIV among MSM and male-to-female transgendered individuals in Pakistan is a significant health concern since access to screening and health-seeking is often delayed in this stigmatised key population.

DESIGN: This cross-sectional study was conducted between March 2016 and November 2017.

PARTICIPANTS, SETTING AND DATA COLLECTION: This study recruited MSM and transgender-women who self-reported to have had anal sex in the last 6 months, and were at least 18 years of age, from the sexual health and antiretroviral therapy centres. Structured questionnaires were administered, and blood samples were obtained to confirm HIV status. Anal swabs were collected for HPV-DNA detection and typing.

MAIN OUTCOME MEASURES: The primary outcome was the prevalence of 'HPV-DNA infection'. The prevalence ratios (PR) were calculated using Cox proportional hazard model algorithms to analyse the association between exposure variables and HPV-infection.

RESULTS: Complete data were available for 298 MSM and transgender women (HIV +n=131; HIV-n=167). The overall HPV-DNA prevalence was 65.1% and was higher in participants living with HIV as compared with HIV-negative (87% vs 48%; χ²p≤0.001). Likewise, 28.9% of participants living with HIV were infected with two or more than two types of HPV as compared with 18.8% participants without HIV(χ² p≤0.001). The most frequent HPV type was HPV6/11 (46.9%), followed by HPV16 (35.1%), HPV18 (23.2%) and HPV35 (21.1%). HIV status (PR 2.81, 95% CI 2.16 to 3.82) and never condom use (PR 3.08, 95% CI 1.69 to 5.60)) were independently associated with prevalence of 'anal-HPV16 infection' when adjusting for confounding for age, other sexual and behavioural factors, for example, smoking and alcohol consumption.

CONCLUSION: High prevalence of HPV indicates a substantial future risk of anal cancer in Pakistani MSM and transgender women, and particularly in those living with HIV. Current findings support anal Pap-smear HPV screening for this particular group and vaccination efforts for future generations.

INTRODUCTION: Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.

METHODS AND ANALYSIS: AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24-72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023-2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.

ETHICS AND DISSEMINATION: Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021-02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice.

TRIAL REGISTRATION NUMBER: NCT05134454.

Objective: There are indications that the prevalence of exclusively breastfed preterm infants is decreasing in Sweden. The objective was to investigate trends in exclusive breast feeding at discharge from Swedish neonatal units and associated factors in preterm infants.

Design, setting and participants: This is a register study with data from the Swedish Neonatal Quality Register. Data from 29 445 preterm infants (gestational age (GA) <37 weeks) who were born during the period 2004–2013 were retrieved. Data included maternal, perinatal and neonatal characteristics. Data were analysed for the whole population as well as for 3 GA groups.

Results: From 2004 to 2013, the prevalence of exclusive breast feeding decreased, in extremely preterm (GA 22–27 weeks) from 55% to 16%, in very preterm (GA 28–31 weeks) from 41% to 34% and in moderately preterm infants (GA 32–36 weeks) from 64% to 49%. The decline was statistically significant (p<0.001) in all 3 GA groups. This decline remained significant when adjustments were made for factors negatively associated with exclusive breast feeding andwhich became more prevalent during the study period, that is, small for GA (all groups) and maternal mental illness (very preterm and moderately preterm infants).

Conclusions: In the past 10 years, Sweden has experienced a lower rate of exclusive breast feeding in preterm infants, especially in extremely preterm infants. The factors analysed in this study explain only a small proportion of this decline. The decline in exclusive breast feeding at discharge from neonatal units raises concern and present challenges to the units to support and promote breast feeding.

OBJECTIVES: To present the 'Wise List' (a formulary of essential medicines for primary and specialised care in Stockholm Healthcare Region) and assess adherence to the recommendations over a 15-year period.

DESIGN: Retrospective analysis of all prescription data in the Stockholm Healthcare Region between 2000 and 2015 in relation to the Wise List recommendations during the same time period.

SETTING: All outpatient care in the Stockholm Healthcare Region.

PARTICIPANTS: All prescribers in the Stockholm Healthcare Region.

MAIN OUTCOME MEASURES: The number of core and complementary substances included in the Wise List, the adherence to recommendations by Anatomic Therapeutic Chemical (ATC) 1st level using defined daily doses (DDDs) adjusted to the DDD for 2015, adherence to recommendations over time measured by dispensed prescriptions yearly between 2002 and 2015.

RESULTS: The number of recommended core substances was stable (175-212). Overall adherence to the recommendations for core medicines for all prescribers increased from 75% to 84% (2000 to 2015). The adherence to recommendations in primary care for core medicines increased from 80% to 90% (2005 to 2015) with decreasing range in practice variation (32% to 13%). Hospital prescriber adherence to core medicine recommendations was stable but increased for the combination core and complementary medicines from 77% to 88% (2007 to 2015). Adherence varied between the 4 therapeutic areas studied.

CONCLUSIONS: High and increasing adherence to the Wise List recommendations was seen for all prescriber categories. The transparent process for developing recommendations involving respected experts and clinicians using strict criteria for handling potential conflicts of interests, feedback to prescribers, continuous medical education and financial incentives are possible contributing factors. High-quality evidence-based recommendations to prescribers, such as the Wise List, disseminated through a multifaceted approach, will become increasingly important and should be developed further to include recommendations and introduction protocols for new expensive medicines.

OBJECTIVES: Knowledge of clinical practice regarding mobilisation after surgery is lacking. This study therefore aimed to reveal current mobilisation routines after abdominal and cardiothoracic surgery and to identify factors associated with mobilisation within 6 hours postoperatively. DESIGN: A prospective observational national multicentre study.

SETTING: 18 different hospitals in Sweden.

PARTICIPANTS: 1492 adult patients undergoing abdominal and cardiothoracic surgery with duration of anaesthesia>2 hours.

PRIMARY AND SECONDARY OUTCOMES: Primary outcome was time to first postoperative mobilisation. Secondary outcomes were the type and duration of the first mobilisation. Data were analysed using multivariate logistic regression and general structural equation modelling, and data are presented as ORs with 95% CIs.

RESULTS: Among the included patients, 52% were mobilised to at least sitting on the edge of the bed within 6 hours, 70% within 12 hours and 96% within 24 hours. Besides sitting on the edge of the bed, 76% stood up by the bed and 22% were walking away from the bedside the first time they were mobilised. Patients undergoing major upper abdominal surgery required the longest time before mobilisation with an average time of 11 hours post surgery. Factors associated with increased likelihood of mobilisation within 6 hours of surgery were daytime arrival at the postoperative recovery unit (OR: 5.13, 95% CI: 2.16 to 12.18), anaesthesia <4 hours (OR: 1.68, 95% CI: 1.17 to 2.40) and American Society of Anaesthesiologists (ASA) classification 1-2, (OR: 1.63, 95% CI: 1.13 to 2.36).

CONCLUSIONS: In total, 96% if the patients were mobilised within 24 hours after surgery and 52% within 6 hours. Daytime arrival at the postoperative recovery unit, low ASA classification and shorter duration of anaesthesia were associated with a shorter time to mobilisation. TRIAL

REGISTRATION NUMBER: FoU, Forskning och Utveckling in VGR, Vastra Gotaland Region (Id:275357) and Clinical Trials (NCT04729634).

Objective: To demonstrate an application of Bayesian model averaging (BMA) with generalised additive mixed models (GAMM) and provide a novel modelling technique to assess the association between inhalable coarse particles (PM10) and respiratory mortality in time-series studies.

Design: A time-series study using regional death registry between 2009 and 2010.

Setting: 8 districts in a large metropolitan area in Northern China.

Participants: 9559 permanent residents of the 8 districts who died of respiratory diseases between 2009 and 2010.

Main outcome measures: Per cent increase in daily respiratory mortality rate (MR) per interquartile range (IQR) increase of PM10 concentration and corresponding 95% confidence interval (CI) in single-pollutant and multipollutant (including NOx, CO) models.

Results: The Bayesian model averaged GAMM (GAMM+ BMA) and the optimal GAMM of PM10, multipollutants and principal components (PCs) of multipollutants showed comparable results for the effect of PM10 on daily respiratory MR, that is, one IQR increase in PM10 concentration corresponded to 1.38% vs 1.39%, 1.81% vs 1.83% and 0.87% vs 0.88% increase, respectively, in daily respiratory MR. However, GAMM+ BMA gave slightly but noticeable wider CIs for the single-pollutant model (-1.09 to 4.28 vs -1.08 to 3.93) and the PCs-based model (-2.23 to 4.07 vs -2.03 vs 3.88). The CIs of the multiple-pollutant model from two methods are similar, that is, -1.12 to 4.85 versus -1.11 versus 4.83.

Conclusions: The BMA method may represent a useful tool for modelling uncertainty in time-series studies when evaluating the effect of air pollution on fatal health outcomes.

INTRODUCTION: Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, can be challenging to diagnose, and treatment outcomes are difficult to predict. In the NORDTREAT cohort study, a Nordic prospective multicentre study, we aim to identify novel molecular biomarkers of diagnostic value by assessing the diagnostic test accuracy (cross-sectionally), as well as the prognostic utility when used as prognostic markers in the long-term (cohort study). In the diagnostic test accuracy study, the primary outcome is a successful diagnosis using one or more novel index tests at baseline compared with the ECCO criteria as the reference standard. The composite outcome of the prognostic utility study is 'severe IBD' within 52 weeks from inclusion, defined as one or more of the following three events: IBD-related surgery, IBD-related hospitalisation or IBD-related death.

METHODS AND ANALYSIS: We aim to recruit 800 patients referred on suspicion of IBD to this longitudinal observational study, a collaboration between 11 inclusion sites in Denmark, Iceland, Norway and Sweden. Inclusion will occur from February 2022 until December 2023 with screening and baseline visits for all participants and three outcome visits at weeks 12, 26 and 52 after baseline for IBD-diagnosed patients. Biological material (blood, faeces, biopsies, urine and hair), clinical data and lifestyle information will be collected during these scheduled visits.

ETHICS AND DISSEMINATION: This study will explore novel biomarkers to improve diagnostic accuracy and prediction of disease progression, thereby improving medical therapy and the quality of life for patients with IBD.The study is approved by the Ethics Committee (DK: S-20200051, v1.4, 16.10.2021; IS: VSNb2021070006/03.01, NO: 193064; SE: DNR 2021-05090) and the Danish Data Protecting Agency (20/54594). Results will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.

CLINICAL TRIAL REGISTRATION NUMBER: NCT05414578; Pre-results.

Objective: The aim of this study was to explore how the COVID-19 pandemic changed the working conditions of physicians in Swedish primary healthcare.

Design: This is a descriptive, qualitative study with individual semistructured interviews. Data were analysed using inductive content analysis. Setting Swedish primary healthcare units in both rural and urban areas.

Participants: A total of 11 primary care physicians fulfilled participation.

Results: Two main categories emerged: 'work organisation and routines' and 'psychosocial work environment', containing three and five subcategories, respectively. The pandemic enforced changes in work organisation and routines. Increased flexibility, including more patient-oriented delivery of care, and novel means of interorganisational and intraorganisational interactions were perceived as positive by physicians. The pandemic also caused several changes in physicians' psychosocial work environment. Increased workload, information overload, as well as ethical considerations and feelings of uncertainty made the work environment stressful for physicians.

Conclusions: The COVID-19 pandemic affected the working conditions of physicians in Swedish primary healthcare in numerous ways. The pandemic enforced changes in work organisation and routines for physicians in primary healthcare. Further research is needed to investigate how the pandemic will affect primary healthcare in the longer term. Learning from the pandemic is important because this will not be the last crisis that primary care and its healthcare professionals will face.

OBJECTIVE: This study aims to investigate the association of ulcerative colitis (UC) with all-cause dementia and assess differences in those with and without a total colectomy.

DESIGN, SETTING AND PARTICIPANTS: This Swedish prospective register-based study comprised 4.8 million individuals aged at least 59 years between 1964 and 2018 with the linkage of several Swedish national registers.

PRIMARY AND SECONDARY OUTCOME MEASURES: Individuals with dementia were defined according to International Classification of Diseases diagnostic codes and Anatomical Therapeutic Classification codes for medication prescriptions. Fitting Cox hazards models, the risk of developing all-cause dementia in individuals with and without UC was estimated. Further, we compared the risk of all-cause dementia among those with and without a colectomy.

RESULTS: Among 4 821 488 individuals (52.6% females) followed for 84.1 million person-years between 1964 and 2018, the incidence rate of all-cause dementia was 63.90 (63.73-64.07) events per 10 000 person-years in individuals without UC, 94.80 (92.04-97.64) among those with UC, 95.01 (92.25-97.86) in those with UC but without colectomy and 63.42 (40.92-98.31) in those with UC and a colectomy. Adjusted Cox models showed an increased all-cause dementia risk in individuals with UC (HR 1.07, 95% CI 1.04 to 1.10). We found no differences between unexposed individuals and those with UC and a colectomy (HR 0.89, 95% CI 0.57 to 1.38).

CONCLUSION: The findings are consistent with previous evidence suggesting a slightly increased dementia risk among individuals with UC. This study provided no evidence of further risk increase of dementia among those who had a colectomy.

Objectives: Systematic review and meta-analysis on the diagnostic accuracy of temporal artery thermometers (TAT).

Design: Systematic review and meta-analysis. The index test consisted of temperature measurement with TAT. The reference test consisted of an estimation of core temperature.

Participants: Clinical patients as well as healthy participants, with or without fever.

Interventions: Literature search in PubMed, Embase, Cinahl and Web of Science. Three reviewers selected articles for full-text reading after which a further selection was made. Risk of bias was assessed with QUADAS-2. Pooled difference and limits of agreement (LoA) were estimated with an inverse variance weighted approach. Subgroup and sensitivity analyses were performed. Sensitivity and specificity were estimated using hierarchical models. Quality of evidence was assessed according to the GRADE system.

Primary and secondary outcome measures: The primary outcome was measurement accuracy expressed as mean difference ±95% LoA. A secondary outcome was sensitivity and specificity to detect fever. If tympanic thermometers were assessed in the same population as TAT, these results were recorded as well.

Results: 37 articles comprising 5026 participants were selected. Pooled difference was -0.19°C (95% LoA -1.16 to 0.77°C), with moderate quality of evidence. Pooled sensitivity was 0.72 (95% CI 0.61 to 0.81) with a specificity of 0.94 (95% CI 0.87 to 0.97). The subgroup analysis revealed a trend towards underestimation of the temperature for febrile patients. There was a large heterogeneity among included studies with wide LoA which reduced the quality of evidence.

Conclusions: TAT is not sufficiently accurate to replace one of the reference methods such as rectal, bladder or more invasive temperature measurement methods. The results are, however, similar to those with tympanic thermometers, both in our meta-analysis and when compared with others. Thus, it seems that TAT could replace tympanic thermometers with the caveat that both methods are inaccurate.

Trial registration number: CRD42014008832.

INTRODUCTION: About 20% of the adult population have chronic pain, often associated with psychological distress, sick leave and poor health. There are large variations in the clinical picture. A biopsychosocial approach is used in investigation and treatment. The concept of personalised medicine, that is, optimising medication types and dosages for individual patients based on biomarkers and other patient-related factors, has received increasing attention in different diseases but used less in chronic pain. This cooperative project from all Swedish University Hospitals will investigate whether there are changes in inflammation and metabolism patterns in saliva and blood in chronic pain patients and whether the changes correlate with clinical characteristics and rehabilitation outcomes.

METHODS AND ANALYSIS: Patients at multidisciplinary pain centres at University Hospitals in Sweden who have chosen to participate in the Swedish Quality Registry for Pain Rehabilitation and healthy sex-matched and age-matched individuals will be included in the study. Saliva and blood samples will be collected in addition to questionnaire data obtained from the register. From the samples, proteins, lipids, metabolites and micro-RNA will be analysed in relation to, for example, diagnosis, pain characteristics, psychological distress, body weight, pharmacological treatment and clinical rehabilitation results using advanced multivariate data analysis and bioinformatics.

ETHICS AND DISSEMINATION: The study is approved by the Swedish Ethical Review Authority (Dnr 2021-04929) and will be conducted in accordance with the declaration of Helsinki.The results will be published in open access scientific journals and in popular scientific relevant journals such as those from patient organisations. Data will be also presented in scientific meetings, meeting with healthcare organisations and disseminated in different lecturers at the clinics and universities.

OBJECTIVE: To determine whether occupational exposure to silica dust is associated with an increased risk of developing sarcoidosis.

DESIGN: Case-control study of all individuals between 20 and 65 years of age diagnosed with sarcoidosis (D86) in Sweden between 2007 and 2016. Controls were matched to cases (2:1) based on age, sex and county at the time of diagnosis. A Job Exposure Matrix was used to estimate the occupational silica exposure of all cases and controls.

SETTING: Medical and occupational data from the National Outpatient Register were used to implement a case-control analysis, while the two controls used for each case were selected from the National Register of the Total Population. Information about occupation and time of employment were collected from the Swedish Occupational Register.

PARTICIPANTS: All men and women aged 20-65 years old who were diagnosed sarcoidosis (D86) from 2007 to 2016 were included and assigned two controls.

MAIN OUTCOMES: Silica dust exposure correlates with an increased risk of developing sarcoidosis in men.

RESULTS: The prevalence of silica exposure at work was statistically significantly higher among male cases than controls (OR 1.27, 95% CI 1.13 to 1.43). For men of an age of 35 years or younger the correlation seems to be stronger (OR 1.48, 95% CI 1.1 to 1.87) than in older men (OR 1.21, 95% CI 1.05 to 1.39). For men older than 35 with exposure to silica the prevalence of sarcoidosis increased with the exposure time, with an OR of 1.44 (95% CI 1.04 to 2.00) for exposure of more than 10 years.

CONCLUSIONS: Occupational exposure to silica dust seems to increase the risk of sarcoidosis among men between 20 and 65 years of age. The risk is higher among exposed men 35 years or younger and older men with longer exposure (>6 years).

Background: A positive patient safety climate within teams has been associated with higher safety performance. The aim of this study was to describe and compare attitudes to patient safety among the various professionals in surgical teams in Swedish operating room (OR) departments. A further aim was to study nurse managers in the OR and medical directors’ estimations of their staffs’ attitudes to patient safety.

Methods: A cross-sectional survey with the Safety Attitudes Questionnaire (SAQ) was used to elicit estimations from surgical teams. To evoke estimations from nurse managers and medical directors about staff attitudes to patient safety, a short questionnaire, based on SAQ, was used. Three OR departments at three different hospitals in Sweden participated. All licensed practical nurses (n=124), perioperative nurses (n=233), physicians (n=184) and their respective manager (n=22) were invited to participate.

Results: Mean percentage positive scores for the six SAQ factors and the three professional groups varied, and most factors (safety climate, teamwork climate, stress recognition, working conditions and perceptions of management), except job satisfaction, were below 60%. Significantly lower mean values were found for perioperative nurses compared with physicians for perceptions of management (56.4 vs 61.4, p=0.013) and working conditions (63.7 vs 69.8, p=0.007). Nurse managers and medical directors’ estimations of their staffs’ ratings of the safety climate cohered fairly well.

Conclusions: This study shows variations and some weak areas for patient safety climate in the studied ORs as reported by front-line staff and acknowledged by nurse managers and medical directors. This finding is a concern because a weak patient safety climate has been associated with poor patient outcomes. To raise awareness, managers need to support patient safety work in the OR.

OBJECTIVES: The work context of the operating room (OR) is considered complex and dynamic with high cognitive demands. A multidimensional view of the complete preoperative and intraoperative work process of the surgical team in the OR has been sparsely described. The aim of this study was to describe the type and frequency of tasks, multitasking, interruptions and their causes during surgical procedures from a multidimensional perspective on the surgical team in the OR.

DESIGN: Prospective observational study using the Work Observation Method By Activity Timing tool.

SETTING: An OR department at a county hospital in Sweden.

PARTICIPANTS: OR nurses (ORNs) (n=10), registered nurse anaesthetists (RNAs) (n=8) and surgeons (n=9).

RESULTS: The type, frequency and time spent on specific tasks, multitasking and interruptions were measured. From a multidimensional view, the surgical team performed 64 tasks per hour. Communication represented almost half (45.7%) of all observed tasks. Concerning task time, direct care dominated the surgeons' and ORNs' intraoperative time, while in RNAs' work, it was intra-indirect care. In total, 48.2% of time was spent in multitasking and was most often observed in ORNs' and surgeons' work during communication. Interruptions occurred 3.0 per hour, and the largest proportion, 26.7%, was related to equipment. Interruptions were most commonly followed by professional communication.

CONCLUSIONS: The surgical team constantly dealt with multitasking and interruptions, both with potential impact on workflow and patient safety. Interruptions were commonly followed by professional communication, which may reflect the interactions and constant adaptations in a complex adaptive system. Future research should focus on understanding the complexity within the system, on the design of different work processes and on how teams meet the challenges of a complex adaptive system.

TRIAL REGISTRATION NUMBER: 2016/264.

OBJECTIVE: The decision whether to initiate intensive care for the critically ill patient involves ethical questions regarding what is good and right for the patient. It is not clear how referring doctors negotiate these issues in practice. The aim of this study was to describe and understand consultants' experiences of the decision-making process around referral to intensive care.

DESIGN: Qualitative interviews were analysed according to a phenomenological hermeneutical method.

SETTING AND PARTICIPANTS: Consultant doctors (n=27) from departments regularly referring patients to intensive care in six UK hospitals.

RESULTS: In the precarious and uncertain situation of critical illness, trust in the decision-making process is needed and can be enhanced through the way in which the process unfolds. When there are no obvious right or wrong answers as to what ought to be done, how the decision is made and how the process unfolds is morally important. Through acknowledging the burdensome doubts in the process, contributing to an emerging, joint understanding of the patient's situation, and responding to mutual moral duties of the doctors involved, trust in the decision-making process can be enhanced and a shared moral responsibility between the stake holding doctors can be assumed.

CONCLUSION: The findings highlight the importance of trust in the decision-making process and how the relationships between the stakeholding doctors are crucial to support their moral responsibility for the patient. Poor interpersonal relationships can damage trust and negatively impact decisions made on behalf of a critically ill patient. For this reason, active attempts must be made to foster good relationships between doctors. This is not only important to create a positive working environment, but a mechanism to improve patient outcomes.

OBJECTIVES: The thrombin inhibitor dabigatran is mainly excreted by the kidneys. We investigated whether the recommended method for estimation of renal function used in the clinical trials, the Cockcroft-Gault (CGold) equation and the estimated glomerular filtration rate (eGFR) modification of diet in renal disease equation 4 (MDRD4), differ in elderly participants, resulting in erroneously higher dose recommendations of dabigatran, which might explain the serious, even fatal, bleeding reported. The renally excreted drugs gabapentin and valaciclovir were also included for comparison.

DESIGN: A retrospective data simulation study.

PARTICIPANTS: Participants 65 years and older included in six different studies.

MAIN OUTCOME MEASURE: Estimated renal function by CG based on uncompensated ('old Jaffe' method) creatinine (CGold) or by MDRD4 based on standardised compensated P-creatinine traceable to isotope-dilution mass spectrometry, and the resulting doses.

RESULTS: 790 participants (432 females), mean age (±SD) 77.6±5.7 years. Mean estimated creatinine clearance (eCrCl) by the CGold equation was 44.2±14.8 ml/min, versus eGFR 59.6±20.7 ml/min/1.73 m(2) with MDRD4 (p<0.001), absolute median difference 13.5, 95% CI 12.9 to 14.2. MDRD4 gave a significantly higher mean dose (valaciclovir +21%, dabigatran +25% and gabapentin +37%) of all drugs (p<0.001). With MDRD4 58% of the women would be recommended a full dose of dabigatran compared with 18% if CGold is used.

CONCLUSIONS: MDRD4 would result in higher recommended doses of the three studied drugs to elderly participants compared with CG, particularly in women, and thus increased the risk of dose and concentration-dependent adverse reactions. It is important to know which method of estimation of renal function the Summary of Products Characteristics was based on, and use only that one when prescribing renally excreted drugs with narrow safety window. Doses based on recently developed methods for estimation of renal function may be associated with considerable risk of overtreatment in the elderly.

INTRODUCTION: The ketogenic diet is a very low carbohydrate diet known for its ability to reduce weight and counteract hyperglycaemia. However, ketogenic diets recommend an increased intake of fats, raising concerns about cardiometabolic risk in adults. Due to the higher intake of fats in the ketogenic diet, there is significant variability in outcomes of lipid metabolism in the population. Interventions have reported improvements in lipid profile while other studies did not find changes, and there are reports of increased low density lipoprotein (LDL) and triglyceride values. Hence, this is a protocol for a systematic review of the published literature and a summary of the effect of ketogenic diets on lipid metabolism in adults.

METHODS AND ANALYSIS: Five databases (PubMed, Embase, Scopus, Cochrane Library and Web of Science) will be searched for studies on ketogenic diets in adult populations. Studies will be included if they report results from ketogenic diet interventions among adults. Exclusion is populations with diagnosed neurological disorders. Two reviewers will independently screen retrieved citations, extract data and appraise the risk of bias. Quantitative estimates (eg, standardised mean difference) measuring the change in the total cholesterol, LDL and triglyceride concentration will be pooled using random effects meta-analysis to produce one summarised weighted estimate. Sources of heterogeneity will be explored using subgroup analysis. This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis for Protocols (PRISMA), and the final review will be reported following the PRISMA 2020 guidelines.

ETHICS AND DISSEMINATION: The present protocol and the systematic review to be carried out do not require ethics clearance. The data source will be published studies. This review will provide estimates to inform the public about the effect of ketogenic diets on lipid metabolism and the possible peril of increasing cardiometabolic risk. The results will be published in a peer-reviewed journal.

PROSPERO REGISTRATION NUMBER: CRD42022309665.

Introduction: Medical adhesives are adhesives used in medical devices to establish and maintain contact with the body over a period of time (usually by application to the skin) and are widely used in most care settings. Application of medical adhesives to the skin can lead to skin stripping, mild or severe allergic reactions and skin irritation that may manifest as redness, itching or rash. Adhesive-related skin injury can lead to infection, delayed wound healing and an increased risk of scarring. These injuries can cause severe discomfort and pain, and can affect the patient’s quality of life. A systematic review summarising patient’s experiences on this topic will contribute to informing adhesive producers and policy makers, and guiding further development and improvement of available technologies.

Methods and analysis: This systematic review protocol is based on the principles of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guideline. A systematic search will be conducted in CINAHL, EMBASE, MEDLINE and PsycINFO. In addition, manual searches will be performed, reviewing the reference lists of relevant reviews and articles included for quality assessment. Qualitative studies using various methods will be considered for inclusion. Screening of title, abstract and full text will be done by two reviewers. The methodological quality of studies under consideration will be critically assessed by two reviewers using the Joanna Briggs Institute Critical Appraisal Tool for Qualitative Research. Data extraction will be performed independently by two reviewers using a predefined data extraction form. Meta-aggregation will be used to summarise the evidence.

Ethics and dissemination No ethical approval or consentis required because no participants will be recruited.This systematic review protocol is published in an openaccess journal to increase transparency of the researchmethods used. Results will be disseminated at nationaland international conferences.

Objective: To perform a cost-effectiveness analysis of a randomised controlled trial of internet-mediated cognitive behavioural therapy (ICBT) compared with treatment as usual (TaU) for patients with mild to moderate depression in the Swedish primary care setting. In particular, the objective was to assess from a healthcare and societal perspective the incremental cost-effectiveness ratio (ICER) of ICBT versus TaU at 12 months follow-up.

Design: A cost-effectiveness analysis alongside a pragmatic effectiveness trial.

Setting: Sixteen primary care centres (PCCs) in south-west Sweden.

Participants: Ninety patients diagnosed with mild to moderate depression at the PCCs.

Main outcome measure: ICERs calculated as (CostICBT-CostTaU)/(Health outcomeICBT-Health outcomeTaU)=ΔCost/ΔHealth outcomes, the health outcomes being changes in the Beck Depression Inventory-II (BDI-II) score and quality-adjusted life-years (QALYs).

Results: The total cost per patient for ICBT was 4044 Swedish kronor (SEK) (€426) (healthcare perspective) and SEK47 679 (€5028) (societal perspective). The total cost per patient for TaU was SEK4434 (€468) and SEK50 343 (€5308). In both groups, the largest cost was associated with productivity loss. The differences in cost per patient were not statistically significant. The mean reduction in BDI-II score was 13.4 and 13.8 units in the ICBT and TaU groups, respectively. The mean QALYs per patient was 0.74 and 0.79 in the ICBT and TaU groups, respectively. The differences in BDI-II score reduction and mean QALYs were not statistically significant. The uncertainty of the study estimates when assessed by bootstrapping indicated that no firm conclusion could be drawn as to whether ICBT treatment compared with TaU was the most cost-effective use of resources.

Conclusions: ICBT was regarded to be as cost-effective as TaU as costs, health outcomes and cost-effectiveness were similar for ICBT and TaU, both from a healthcare and societal perspective.

Trial registration number: ID NR 30511.

Objective: To explore the relationship between preparations and real-life experiences among prehospital major incident commanders.

Design: An explorative, qualitative design was used.

Setting: Prehospital major incidents in Sweden. Data were collected between December 2019 and August 2020.

Participants: Prehospital major incident commanders (n=15) with real-life experiences from major events, such as fires, bus accidents, a bridge collapse and terrorist attacks, were included. All but one had participated in 2-day training focusing on the prehospital management of major incidents. In addition, about half of the participants had participated in simulation exercises, academic courses and other training in the management of major incidents.

Methods: Data from two-session individual interviews were analysed using inductive thematic analysis.

Results: The conformity between real-life major incidents and preparations was good regarding prehospital major incident commanders' knowledge of the operational procedures applied in major incidents. However, the preparations did not allow for the complexities and endurance strategies required in real-life incidents. Personal preparations, such as mental preparedness or stress management, were not sufficiently covered in the preparations. To some extent, professional experience (such as training) could compensate for the lack of formal preparations.

Conclusions: This study identified perceived gaps between preparations and real-life experiences of being a prehospital major incident commander. To minimise the gaps between demands and expectations on perceived control and to better prepare individuals for being prehospital major incident commanders, the training and other preparations should reflect complexities of real-life incidents. Preparations should develop both technical skills required, such as principles and methodology used, and personal preparedness. Personal preparations should include improving one's mental preparedness, self-knowledge and professional self-confidence required to successfully act as a prehospital incident commander. Since little is known about what pedagogical methods that should be used to enhance this, further research is needed.

INTRODUCTION: Real-time continuous glucose monitoring (rt-CGM) informs users about current interstitial glucose levels and allows early detection of glycaemic excursions and timely adaptation by behavioural change or pharmacological intervention. Randomised controlled studies adequately powered to evaluate the impact of long-term application of rt-CGM systems on the reduction of adverse obstetric outcomes in women with gestational diabetes (GDM) are missing. We aim to assess differences in the proportion of large for gestational age newborns in women using rt-CGM as compared with women with self-monitored blood glucose (primary outcome). Rates of neonatal hypoglycaemia, caesarean section and shoulder dystocia are secondary outcomes. A comparison of glucose metabolism and quality of life during and after pregnancy completes the scope of this study.

METHODS AND ANALYSIS: Open-label multicentre randomised controlled trial with two parallel groups including 372 female patients with a recent diagnosis of GDM (between 24+0 until 31+6 weeks of gestation): 186 with rt-CGM (Dexcom G6) and 186 with self-monitored blood glucose (SMBG). Women with GDM will be consecutively recruited and randomised to rt-CGM or control (SMBG) group after a run-in period of 6-8 days. The third visit will be scheduled 8-10 days later and then every 2 weeks. At every visit, glucose measurements will be evaluated and all patients will be treated according to the standard care. The control group will receive a blinded CGM for 10 days between the second and third visit and between week 36+0 and 38+6. Cord blood will be sampled immediately after delivery. 48 hours after delivery neonatal biometry and maternal glycosylated haemoglobin A1c (HbA1c) will be assessed, and between weeks 8 and 16 after delivery all patients receive a re-examination of glucose metabolism including blinded CGM for 8-10 days.

ETHICS AND DISSEMINATION: This study received ethical approval from the main ethic committee in Vienna. Data will be presented at international conferences and published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER: NCT03981328; Pre-results.

PURPOSE: We constructed Bladder Cancer Data Base Sweden (BladderBaSe) 2.0 to expand studies in BladderBaSe on incidence, treatment outcomes, side effects, survival and health economic aspects of men and women with cancer in the urinary bladder, upper tract urothelial carcinoma (UTUC) (renal pelvis and ureter) and urethral carcinoma.

PARTICIPANTS: BladderBaSe 2.0 includes 53 298 patients with cancer in the urinary bladder, diagnosed from 1 January 1997 to 31 December 2019, and 961 patients with UTUC in the renal pelvis and 792 in the ureter, and 146 patients with urethral urothelial carcinoma, diagnosed from 1 January 2015 to 31 December 2019, and in total 275 816 participants in reference groups, free of cancer in the urinary tract, matched 1:5 on sex, age and county.

FINDINGS TO DATE: To date, 18 published studies based on data from the BladderBaSe have investigated calendar time trends in survival; impact of gender, socioeconomic factors, tumour aggressiveness and hospital volume for radical cystectomy on prognosis; survival after radical cystectomy compared with radical radiotherapy; risk factors for complications and side effects after radical cystectomy such as thromboembolism, strictures of ureteroenterostomies and incisional hernia.

FUTURE PLANS: The BladderBaSe initiators are currently investigating gender-dependent detection delays due to urinary tract infections; survival after non-muscle invasive bladder cancer with respect to the number of transurethral resections; short-term outcomes comparing open and robot-assisted radical cystectomy; studies on risk for intravesical recurrence after different diagnostic measures in UTUC, and suicide risk after bladder cancer diagnosis. The BladderBaSe project group is open for collaborations with national and international colleagues.

Objectives: To define and validate types of pain in critically ill neonates and infants by researchers and clinicians working in the neonatal intensive care unit (NICU) and high dependency unit (HDU).

Design: A qualitative descriptive mixed-methods design.

Procedure/s: Each stage of the study was built on and confirmed the previous stages. Stage 1 was an expert panel to develop definitions; stage 2 was a different expert panel made up of neonatal clinicians to propose clinical characteristics associated with the definitions from stage 1; stage 3 was a focus group of neonatal clinicians to provide clinical case scenarios associated with each definition and clinical characteristics; and stage 4 was a survey administered to neonatal clinicians internationally to test the validity of the definitions using the clinical case scenarios.

Results: In stage 1, the panel (n=10) developed consensus definitions for acute episodic pain and chronic pain in neonates and infants. In stage 2, a panel (n=8) established clinical characteristics that may be associated with each definition. In stage 3, a focus group (n=11) created clinical case scenarios of neonates and infants with acute episodic pain, chronic pain and no pain using the definitions and clinical characteristics. In stage 4, the survey (n=182) revealed that the definitions allowed an excellent level of discrimination between case scenarios that described neonates and infants with acute episodic pain and chronic pain (area under the receiver operating characteristic=0.87 and 0.89, respectively).

Conclusions: This four-stage study enabled the development of consensus-based and clinically valid definitions of acute episodic pain and chronic pain. There is a need to define and validate other pain types to inform a taxonomy of pain experienced by neonates and infants in the NICU and HDU.

OBJECTIVES: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.

METHODS: The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.

RESULTS: 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.

CONCLUSION: Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.

INTRODUCTION: A person-centred approach, to know about a person's individual weaknesses and strengths, is warranted in today's healthcare in Sweden. When a person suffers from obesity, there are not only risks for comorbidities but also increased risk for decreased health-related quality of life (HRQoL). After bariatric surgery, there are also risks for complications; however, healthcare service expects the person to have sufficient ability to handle recovery after surgery. The need is to investigate how a person's self-efficacy and health literacy(HL) skills are important to determine their effect on recovery as well as HRQoL after bariatric surgery. It can, involve the person in the care, improve shared decision-making, and perhaps decrease complications and readmissions.

METHOD AND ANALYSIS: This is a prospective, longitudinal mixed-methods study with the intent of including 700 patients from three bariatric centres in Sweden (phase 1); 20 patients will be included in a qualitative study (phase 2). Inclusion criteria will be age >17 years, scheduled primary bariatric surgery and ability to read and understand the Swedish language in speech and in writing. Inclusion criteria for the qualitative study will be patients who reported a low self-efficacy, with a selection to ensure maximum variation regarding age and gender. Before bariatric surgery patients will answer a questionnaire including 20 items. Valid and reliable instruments will be used to investigate general self-efficacy (10 items) and functional and communicative and critical HL (10 items). This data collection will then be merged with data from the Scandinavian Obesity Surgery Registry. Analysis will be performed 30 days, 1 year and 2 years after bariatric surgery. One year after bariatric surgery the qualitative study will be performed. The main outcomes are the impact of a person's self-efficacy and HL on recovery after bariatric surgery.

ETHICS AND DISSEMINATION: The study has received approval from the ethical review board in Uppsala, Sweden (number 2018/256). The study results will be disseminated through peer-reviewed publications and conference presentations to the scientific community and social media.

OBJECTIVES: The aim was to psychometrically test and evaluate the Swedish functional health literacy scale and the Swedish communicative and critical health literacy scale in patients undergoing bariatric surgery.

DESIGN: A prospective cross-sectional psychometric study.

SETTING: Patients from three bariatric centres in Sweden were consecutively included in this study.

PARTICIPANTS: A total of 704 patients undergoing bariatric surgery filled in the questionnaires preoperatively. Inclusion criteria were scheduled for primary bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) and greater than 17 years, proficiency in Swedish.

PRIMARY AND SECONDARY MEASURES: Psychometric outcomes of the Swedish Functional Health Literacy scale and the Swedish Communicative and Critical Health Literacy scale.

RESULTS: There was a higher proportion of females (74.4%, n=523) to males (25.6%, n=180). The mean age was 42 years (SD 11.5). Limited functional health literacy and limited communicative and critical health literacy (including both inadequate and problematic health literacy) was reported in 55% (n=390) and 40% (n=285), respectively. Cronbach alpha for the Swedish Functional Health Literacy scale was α=0.86 and for the Swedish Communicative and Critical Health Literacy scale, α=0.87. Construct validity showed weak to negative correlations between the Swedish Functional Health Literacy scale and income, education and SF-36/RAND36 summary scores. Confirmatory factor analysis showed a one-factor solution for the Swedish Functional Health Literacy scale and a two-factor solution for the Swedish Communicative and Critical Health Literacy scale.

CONCLUSIONS: The Swedish Functional Health Literacy scale and the Swedish Communicative and Critical Health Literacy scale are valid and reliable to use for patients undergoing bariatric surgery in a Swedish context. Measuring dimensions of health literacy can be used as a guide for the development of health literacy friendly patient information in patients undergoing bariatric surgery.

Objectives: To identify rates of additional operation after the index operation for degenerative lumbar spine diseases.Design Retrospective register study.Setting National outcome data from Swespine, the National Swedish spine register.

Participants: A total of 4705 patients who underwent one-level surgery for degenerative disk disease (DDD) or lumbar spinal stenosis (LSS) with or without degenerative spondylolisthesis (DS) between 1 January 2007 and 31 December 2010 were followed from 1 January 2007 to 31 December 2020 to record all cases of additional lumbar spine operations.Interventions One-level spinal decompression and/or posterolateral fusion for degenerative spine diseases.

Primary outcome measures: Number of additional operations.

Results: Additional operations were more common at adjacent levels for patients with LSS with DS treated with decompression and fusion whereas additional operations were more evenly distributed between the index level and the adjacent levels for DDD treated with fusion and LSS with and without DS treated with decompression only. For patients younger than 60 years, treated with decompression and fusion for LSS with DS, the additional operations were evenly distributed between the index level and the adjacent levels.

Conclusions: There are different patterns of additional operations following the index procedure after surgery for degenerative spine diseases. Rigidity across previously mobile segments is not the only important factor in the development of adjacent segment disease (ASD) after spinal fusion, also the underlying disease and age may play parts in ASD development. The findings of this study can be used in the shared decision-making process when surgery is a treatment option for patients with degenerative lumbar spine diseases as the first operation may be the start of a series of additional spinal operations for other degenerative spinal conditions, either at the index level or at other spinal levels.