Prospective risk of Type 2 diabetes in 99 892 Nordic women with polycystic ovary syndrome and 446 055 controls: national cohort study from Denmark, Finland, and Sweden.

STUDY QUESTION: What is the prospective risk of Type 2 diabetes (T2D) in Nordic women with polycystic ovary syndrome (PCOS) compared to controls? SUMMARY ANSWER: A diagnosis of PCOS and BMI ≥30 kg/m2 is a high-risk phenotype for a prospective risk of T2D diagnosis across Nordic countries. WHAT IS KNOWN ALREADY: The risk of T2D in women with PCOS is increased. The risk of T2D is related to BMI and the magnitude of risk in normal weight women with PCOS has been discussed. However, prospective data regarding risk of T2D in population-based cohorts of women with PCOS are limited. STUDY DESIGN, SIZE, DURATION: This national register-based study included women with PCOS and age-matched controls. The main study outcome was T2D diagnosis occurring after PCOS diagnosis. T2D was defined according to ICD-10 diagnosis codes and/or filled medicine prescriptions of anti-diabetic medication excluding metformin. PARTICIPANTS/MATERIALS, SETTING, METHODS: The study cohort included women originating from Denmark (PCOS Denmark, N = 27 016; controls, N = 133 994), Finland (PCOS Finland, N = 20 467; controls, N = 58 051), and Sweden (PCOS Sweden, N = 52 409; controls, N = 254 010). The median age at cohort entry was 28 years in PCOS Denmark, Finland, and Sweden with a median follow-up time (interquartile range) in women with PCOS of 8.5 (4.0-14.8), 9.8 (5.1-15.1), and 6.0 (2.0-10.0) years, respectively. Cox regression analyses were adjusted for BMI and length of education. MAIN RESULTS AND THE ROLE OF CHANCE: The crude hazard ratio (HR, 95% CI) for T2D diagnosis in women with PCOS was 4.28 (3.98-4.60) in Denmark, 3.40 (3.11-3.74) in Finland, and 5.68 (5.20-6.21) in Sweden. In adjusted regression analyses, BMI ≥30 vs <25 kg/m2 was associated with a 7.6- to 11.3-fold risk of T2D. In a combined meta-analysis (PCOS, N = 99 892; controls, N = 446 055), the crude HR for T2D in PCOS was 4.64 (3.40-5.87) and, after adjustment for BMI and education level, the HR was 2.92 (2.32-3.51). LIMITATIONS, REASONS FOR CAUTION: Inclusion of more severe cases of PCOS in the present study design could have lead to an overestimation of risk estimates in our exposed population. However, some women in the control group would have undiagnosed PCOS, which would lead to an underestimation of T2D risk in women with PCOS. BMI data were not available for all participants. The present study should be repeated in study cohorts with higher background risks of T2D, particularly in populations of other ethnicities. WIDER IMPLICATIONS OF THE FINDINGS: The prospective risk for diagnosis of T2D is increased in women with PCOS, and the risk is aggravated in women with BMI ≥30 kg/m2. STUDY FUNDING/COMPETING INTEREST(S): Funding in Denmark was from the Region of Southern Denmark, Overlægerådet, Odense University Hospital. Funding in Finland was from Novo Nordisk Foundation, Finnish Research Council and Sigrid Juselius Foundation, the National Regional Fund, Sakari Alhopuro Foundation and Finnish Diabetes Research Foundation. E.E. has received a research grant from Ferring Pharmaceuticals (payment to institution) and serves as medical advisor for Tilly AB, not related to this manuscript. The remaining authors declare no conflict of interest. TRIAL REGISTRATION NUMBER: N/A.

Statistical Analysis Plan for the AIRCARD Study: Individual Long-term Air and Noise Pollution Exposure and Cardiovascular Disease Incidence and Mortality (AIRCARD): A Prospective Cohort Study Utilizing DANCAVAS and VIVA Screening Trials.

INTRODUCTION: The AIRCARD study is designed to investigate the relationship between long-term exposure to air and noise pollution and cardiovascular disease incidence and mortality. We aim to conduct a robust prospective cohort analysis assessing the cumulative and differential impacts of air and noise pollution exposure on cardiovascular disease and mortality. This study will adjust for relevant confounders, including traditional cardiovascular risk factors, socioeconomic indicators, and lipid-lowering agents. METHODS: This prospective cohort study will include 27,022 male participants aged 65-74, recruited from the two large Danish DANCAVAS and VIVA trials, both population-based randomized, multicentered, clinically controlled studies. We will assess long-term exposure to air pollutants using the state-of-the-art DEHM/UBM/AirGIS modelling system and noise pollution through the Nord2000 and SoundPLAN models, covering data from 1979 to 2019. This statistical analysis plan is strictly formulated to predefine the analytical approach for all outcomes and key study variables before data access. The primary analysis will utilize Cox proportional hazards models, adjusted for confounders identified in our cohort (age, body mass index, hypertension, diabetes, smoking status, family history of heart disease, socioeconomic factors, and lipid-lowering agents). This statistical analysis plan further includes Spearman rank correlation to explore inter-pollutant associations. CONCLUSION: The AIRCARD study addresses global concerns about the impact of air and noise pollution on cardiovascular disease. This research is important for understanding how the pollutants contribute to cardiovascular disease. We aim to provide insights into this area, emphasizing the need for public health measures to mitigate pollution exposure. Our goal is to provide policymakers and healthcare professionals with information on the role of environmental factors in cardiovascular health that could influence global strategies to reduce the cardiovascular disease burden associated with pollution. The design of this SAP ensures transparency and.

Rehabilitation interventions for young adult cancer survivors: A scoping review.

OBJECTIVE: To map existing research concerning rehabilitation interventions for young adult cancer survivors (YACS) that address at least one factor from the biopsychosocial health model. DESIGN: Scoping review. DATA SOURCES: Searches were performed in EMBASE, MEDLINE, PsycINFO, CINAHL and Cochrane in January 2022 and updated in March 2023, and grey literature between February and April 2022. METHODS: The review followed Joanna Briggs Institute's methodology for scoping reviews. Quantitative, qualitative and mixed methods studies evaluating interventions for YACS of any cancer who had completed primary treatment and were between 18 and 39 years old at diagnosis were included. Two authors independently screened studies for eligibility, and standardised forms were used for data extraction. Descriptive statistics, narrative summaries and thematic analysis were used to analyse the data. RESULTS: The search revealed 5706 records, of which 70 were full-text screened. The 20 included studies represented a heterogeneous group of 444 young adults with different cancer types, mean age above 25, and an overrepresentation of females. Most studies were feasibility and pilot studies. The 20 studies consisted of 14 unique interventions focusing primarily on one dimension of the biopsychosocial health model like biological or psychological factors. In the 14 interventions, the most frequent intervention element was peer-to-peer support (n = 12). The interventions were often delivered online (n = 9), lasting 3-12 months (n = 8). A wide variety of theories, providers and outcome measures were used. CONCLUSION: The results show that current research on multicomponent, biopsychosocial and age-specific rehabilitation for YACS remains at an early stage.

Identification of socially vulnerable cancer patients - development of a register-based index (rSVI).

BACKGROUND: Social vulnerability is a complex construct which is beyond relying on single measures. If socially vulnerable patients should be identified, we need a composite measure capturing the patient's overall circumstances. This study presents the development of a social vulnerability index (rSVI) for cancer patients based on administrative data from population-based registers. METHODS: All patients, who died from cancer within 5 years after the cancer diagnosis during 2013-2018 (n = 44,187), were identified and divided in four subcohorts according to survival; index cohort surviving 3-5 years (n = 3044 surviving 3-5 years), cohort 1 (n = 27,170 surviving < 1 year), cohort 2 (n = 9450 surviving 1-2 years), and cohort 3 (n = 4523 surviving 2-3 years). Variables from ten registries on health and social issues were linked to each individual patient. Variables of interest were weighted to construct the rSVI using the index-cohort. rSVI was subsequently tested on the three other cohorts for validation. RESULTS: The rSVI included weighted values for marital status, ethnicity, education, income, unemployment, psychiatric comorbidity, and somatic comorbidity. The validity of the rSVI was supported by the expected trend in proportions of vulnerable patients when applied on the other cohorts. Single social measures appeared insufficient in identification of vulnerable patients when compared with the rSVI. CONCLUSION: The rSVI provides a tool for identification of socially vulnerable cancer patients using administrative data. The index requires further validation in other patient groups and is tested against other measures of vulnerability. Future perspectives are to use the rSVI as predictor of advanced cancer patients' use of healthcare services.

Rationale and design of a randomised controlled trial investigating the effect of multidisciplinary nutritional rehabilitation for patients treated for head and neck cancer (the NUTRI-HAB trial).

BACKGROUND: Eating problems frequently affect quality of life and physical, psychological and social function in patients treated for head and neck cancer (HNC). Residential rehabilitation programmes may ameliorate these adverse effects but are not indicated for all individuals. Systematic assessment of rehabilitation needs may optimise the use of resources while ensuring referral to rehabilitation for those in need. Yet, evidence lacks on which nutrition screening and assessment tools to use. The trial objectives are: 1) To test the effect of a multidisciplinary residential nutritional rehabilitation programme compared to standard care on the primary outcome body weight and secondary outcomes health-related quality of life, physical function and symptoms of anxiety and depression in patients curatively treated for HNC and 2) To test for correlations between participants' development in outcome scores during their participation in the programme and their baseline scores in Nutritional Risk Screening 2002 (NRS 2002), the Scored Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF), and M. D. Anderson Dysphagia Inventory (MDADI) and to assess sensitivity, specificity and predictive values of the three tools in relation to a clinically relevant improvement in outcome scores. METHODS: In a randomised controlled trial, 72 patients treated for HNC recruited through a nationwide survey will be randomised to a multidisciplinary residential nutritional rehabilitation programme or to a wait-list control group. Data are collected at baseline, three and six months. Primary outcome is change in body weight, and secondary outcomes include changes in quality of life, physical function and symptoms of anxiety and depression. Potential correlations between intervention effect and baseline scores in NRS 2002, PG-SGA-SF and MDADI will be tested, and sensitivity, specificity and predictive values of the three tools in relation to a clinically relevant improvement in outcome scores will be assessed. DISCUSSION: This is the first randomised controlled trial to test the effect of a multidisciplinary residential nutritional rehabilitation programme in patients treated for HNC. Recruitment through a nationwide survey gives a unique possibility to describe the trial population and to identify potential selection bias. As the trial will explore the potential of different nutrition screening and assessment tools in the assessment of rehabilitation needs in patients treated for HNC, the trial will create knowledge about how selection and prioritisation of nutritional rehabilitation aimed at patients treated for HNC should be offered. The results may contribute to a better organisation and use of existing resources in benefit of patients treated for HNC. TRIAL REGISTRATION: The trial is registered by The Danish Data Protection Agency (registration 2012-58-0018, approval number 18/14847) and the Regional Committees on Health Research Ethics for Southern Denmark (journal number 20182000-165). ClinicalTrials.gov Identifier: NCT03909256. Registered April 9, 2019.

Associations between perceived information needs and anxiety/depressive symptoms among cancer caregivers: A cross-sectional study.

Purpose: Caregivers to cancer patients often experience information needs. This study investigates the associations between perceived information needs and anxiety/depressive symptoms among caregivers to cancer patients.Design: Cross-sectional study using self-completed questionnaires.Sample: A total of 128 caregivers to cancer patients who participated in a rehabilitation stay at REHPA, The Danish Knowledge Center for Rehabilitation and Palliative Care, from April 2016 to March 2017.Methods: The caregivers completed a questionnaire assessing both information needs and anxiety/depressive symptoms. We used ordinal logistic regressions to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the associations between seven information needs and anxiety/depressive symptoms. The reference group was caregivers with no perceived information needs.Findings: The combined score of perceived information needs was associated with higher odds of anxiety (OR = 3.86 per unit increase, 95% CI 1.85-8.03) and depressive symptoms (OR = 3.83 per unit increase, 95% CI 1.15-12.75). For the individual items, our results showed higher odds of anxiety symptoms for caregivers with perceived information needs regarding (1) the disease and its course, for both little need for information (OR = 3.62, 95% CI 1.39-9.43) and substantial need for information (OR = 4.57, 95% CI 1.40-14.93); however, for substantial information needs, an interaction with gender was found showing higher odds for men (OR = 28.90, 95% CI 4.46-187.41), but no significant association for women. Also, substantial need for information regarding the disease and its course were associated with higher odds of depressive symptoms (OR = 11.43, 95% CI 1.18-111.21). Furthermore, we found higher odds of anxiety symptoms for caregivers who perceived information needs regarding (2) which symptoms and adverse effects to be aware of; (3) how to help and support a cancer patient; (4) expected mental responses in a person with cancer; (5) how to find information on the internet, and (6) where to direct caregiver questions and/or concerns after patient discharge.Conclusions: Among caregivers to cancer patients, perceived needs regarding the disease and its course were associated with higher odds of anxiety and depressive symptoms. Furthermore, several other information needs were associated with anxiety symptoms.Implications for Psychosocial Providers or Policy: To prevent unnecessary anxiety and depressive symptoms among cancer caregivers, health care professionals should be aware of the importance of informing caregivers regarding the disease and its course. Other issues to address concerning anxiety symptoms are information regarding which symptoms and adverse effects to be aware of; how to help and support a cancer patient; expected mental responses in a person with cancer; how to find information on the internet; and where to direct caregiver questions and/or concerns after patient discharge.

Gender affirming treatment and employment rate in 3,812 Danish transgender persons and 38,120 controls.

OBJECTIVE: Gender affirming care could be associated with higher employment rate. We assessed employment rates in transgender persons compared to controls and demographic, health and treatment-related factors associated with employment in transgender persons. METHODS: National register-based cohort study in Danish persons with diagnosis code of gender dysphoria during year 2000-2021. Five age-matched controls of the same sex at birth and five age-matched controls of the other sex at birth were included. The date of study inclusion was the first date of transgender diagnosis. Employment was the primary study outcome. RESULTS: The cohort included 3,812 transgender persons and 38,120 cisgender controls. The median age (interquartile range) was 19 (15; 24) years for transgender men, n = 1,993 and 23 (19; 33) years for transgender women, n = 1,819. In transgender men compared to control cisgender women, the odds ratio (95% confidence interval) for employment was 0.33 (0.29; 0.38) before study inclusion and 0.24 (0.20; 0.29) in the fifth calendar year after index; in transgender women compared to control cisgender men, corresponding ORs were 0.30 (0.70; 0.34) and 0.21 (0.18; 0.25). Similar findings were found between transgender persons and cisgender controls of other sex. Use of gender affirming hormone in transgender men increased probability of employment at all time points with odds ratio after 5 years: 1.61 (1.08; 2.42), p = 0.02 (95% confidence interval). In transgender women, use of hormone treatment was not associated with changed employment rates, 5 years odds ratio 1.31 (0.94; 1.82), p = 0.11. CONCLUSION: Masculinizing hormone treatment was associated with higher probability of employment.

Gender-affirming treatment and mental health diagnoses in Danish transgender persons: a nationwide register-based cohort study.

IMPORTANCE: Gender affirming treatment aims to improve mental health. OBJECTIVE: To investigate longitudinal mental health outcomes in Danish transgender persons. DESIGN: National register-based cohort study in Danish transgender persons with diagnosis code of "gender identity disorder" during the period 2000-2021. PARTICIPANTS: Five age-matched controls of the same sex at birth and five age-matched controls of the other sex at birth were included for each transgender person. MAIN OUTCOMES: Diagnosis codes of mental and behavioral disorders and/or prescription of psychopharmacological agents until June 2022. RESULTS: The cohort included 3812 transgender persons with median age (interquartile range) 19 (15; 24) years for persons assigned female at birth (AFAB, N = 1993) and 23 (19; 33) years for persons assigned male at birth (AMAB, N = 1819) and 38 120 controls. Follow up duration was up to 10 years with mean (standard deviation) 4.5 (4.3) years. In transgender persons AFAB compared to control women, the odds ratio (OR) (95% confidence interval) for mental and behavioral disorders was 6.7 (5.5; 8.1) before the index date, 9.9 (8.4; 11.7) at 1 year, 5.8 (4.4; 7.7) at 5 years, and 3.4 (2.1; 7.5) at 8 years follow up. In transgender persons AMAB compared to control men, corresponding ORs were 5.0 (4.0; 6.4), 11.3 (9.3; 13.7), 4.8 (3.5; 6.5), and 6.6 (4.2; 10.3) at 8 years follow up (all P < .001). CONCLUSION: The OR for mental health disorders was higher in transgender persons compared to controls and remained elevated throughout follow up, especially in transgender persons AMAB.

Social vulnerability among cancer patients and changes in vulnerability during their trajectories - A longitudinal population-based study.

BACKGROUND: Identification of socially vulnerable cancer patients in the health care system is difficult. Only little is known concerning changes in the patients' social circumstances during the trajectory. Such knowledge is valuable regarding the identification of socially vulnerable patients in the health care system. The objective of this study was to use administrative data to identify population-based characteristics of socially vulnerable cancer patients and investigate how social vulnerability changed during the cancer trajectory. METHODOLOGY: A registry-based social vulnerability index (rSVI) was applied to each cancer patient prior to their diagnosis, and used to assess changes in social vulnerability after the diagnosis. RESULTS: A total of 32,497 cancer patients were included. Short-term survivors (n = 13,994) died from cancer from one to three years after the diagnosis, and long-term survivors (n = 18,555) survived at least three years after the diagnosis. 2452 (18 %) short-term survivors and 2563 (14 %) long-term survivors were categorized as socially vulnerable at diagnosis, of these 22 % and 33 % changed category to not socially vulnerable during the first two years after the diagnosis, respectively. For patients changing status of social vulnerability, several social and health-related indicators changed, which is in line with the complexity of the multifactorial social vulnerability. Less than 6 % of the patients categorized as not vulnerable at diagnosis, changed to become vulnerable during the following two years. CONCLUSION: During the cancer trajectory, social vulnerability may change in both directions. Surprisingly, more patients, who were categorized as socially vulnerable when their cancer was diagnosed, changed status to not socially vulnerable during follow-up. Future research should attempt to increase knowledge on identifying cancer patients, who experience deterioration after the diagnosis.

The use and timing of rehabilitation and palliative care to cancer patients, and the influence of social vulnerability - a population-based study.

OBJECTIVES: To identify and investigate different cohorts of cancer patients' use of physical rehabilitation and specialised palliative care (SPC) services, focusing on patients with incurable cancer and the impact of social vulnerability. METHODS: The sample originated from patients diagnosed during 2013-2018 and alive 1 January 2015. Use of physical rehabilitation and/or SPC units were identified from contacts registered in population-based administrative databases. Competing-risks regression models were applied to investigate disparities with regard to social vulnerability, disease duration, gender and age. RESULTS: A total of 101 268 patients with cancer were included and 60 125 survived longer than 3 years after their diagnosis. Among the 41 143 patients, who died from cancer, 66%, survived less than 1 year, 23% survived from 1 to 2 years and 11% survived from 2 to 3 years. Contacts regarding physical rehabilitation services appeared in the entire cancer trajectory, whereas contacts regarding SPC showed a steep increase as time drew closer to death. The largest disparity was related to disease duration. Socially vulnerable patients had less contact with SPC, while a larger proportion of the socially vulnerable cancer survivors used rehabilitation, compared with the non-vulnerable patients. CONCLUSIONS: This study provides a previously unseen detailed overview of the use of physical rehabilitation and/or SPC among patients with incurable cancer. The services appeared to overlap at a group level in the cancer trajectory, emphasising the importance of awareness with regard to coordination and combination of the services. Disparities between socially vulnerable or non-vulnerable patients were identified.

Effects of a Multidisciplinary Residential Nutritional Rehabilitation Program in Head and Neck Cancer Survivors-Results from the NUTRI-HAB Randomized Controlled Trial.

Head and neck cancer survivors frequently experience nutritional challenges, and proper rehabilitation should be offered. The trial objective was to test the effect of a multidisciplinary residential nutritional rehabilitation programme addressing physical, psychological, and social aspects of eating problems after treatment. In a randomized controlled trial, 71 head and neck cancer survivors recruited through a nationwide survey were randomized to the program or a wait-list control group. Inclusion was based on self-reported interest in participation. The primary outcome was change in body weight. Secondary outcomes included physical function, quality of life, and symptoms of anxiety and depression. Differences between groups at the 3-month follow-up were tested. No significant differences were seen in body weight change, but there were overall trends towards greater improvements in physical function (hand grip strength: p = 0.042; maximal mouth opening: p = 0.072) and quality of life ("Role functioning": p = 0.041; "Speech problems": p = 0.040; "Pain": p = 0.048) in the intervention group. To conclude, a multidisciplinary residential nutritional rehabilitation program had no effect on body weight in head and neck cancer survivors with self-reported interest in participation, but it may have effect on physical function and quality of life. Further research on relevant outcomes, inclusion criteria, and the program's effect in different subgroups is needed.