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Aims: The aim of this work is to describe opioid initiation and long‐term use after emergency department (ED) visits or hospitalizations in New South Wales, Australia, by patient, admission and clinical characteristics. Methods: This is a population‐based cohort study, including all hospitalizations and ED visits between 2014 and 2020, linked to medicine dispensings, deaths and cancer registrations (Medicines Intelligence Data Platform), among adults with no opioid dispensings in the previous year. Outcome measures were opioid initiations (dispensed within 7 days of discharge) and long‐term use (90 days of continuous exposure, 90–270 days after initiation). Results: The cohort included 16 153 096 admissions by 4.2 million opioid‐naïve adults; 39.0% were ED presentations without hospital admission, 16.8% hospital admissions via ED and 44.2% direct hospital admissions. Opioids were initiated post‐discharge for 6.2% of ED, 8.3% of hospital via ED and 10.0% of direct hospital admissions; of these 1.0%, 2.5% and 0.5% progressed to long‐term opioid use, respectively. Initiation was lowest in obstetric admissions without surgery (1.0%), and highest among trauma admissions (25.4%), obstetric admissions with surgical intervention (19.8%) and non‐trauma surgical admissions (12.0%). Long‐term use was highest among medical admissions via ED (3.5%), trauma admissions (2.3%) and ED alone (1.0%). From 2014 to 2020, overall opioid initiations decreased 16% from 8.7% to 7.2%, and long‐term opioid use decreased 33% from 1.3% to 0.8%. Conclusions: Both opioid initiation and long‐term use decreased over time; however, the higher rates of long‐term use following trauma, and medical admissions via ED, warrant further surveillance. Strategies supporting appropriate prescribing and access to multidisciplinary pain services will facilitate best practice care. [ABSTRACT FROM AUTHOR]

Summary: Background: Prescribed opioid analgesics are frequently used to manage pain in pregnancy. However, the available literature regarding the teratogenic potential of opioid use during pregnancy has not been systematically summarised. This systematic review and meta‐analysis aimed to assess the quality of the evidence on these potential risks and calculate a pooled estimate of risk for any opioid analgesic and individual opioids. Methods: We searched PubMed, Embase and CINAHL for published studies assessing the risk of major congenital malformations in infants following first‐trimester exposure to opioid analgesics compared with a reference group, excluding studies examining opioid agonist therapy or illicit opioid use. We assessed the risk of bias using the Risk of Bias in Non‐Randomised Studies of Intervention tool. We pooled adjusted risk estimates from studies rated at serious risk of bias or better in a random‐effects meta‐analysis. Results: Of 12 identified studies, 11 were at high risk of bias (eight serious; three critical). Relative to unexposed infants, those exposed to any opioid use during the first trimester of pregnancy were not at an increased risk of major congenital malformations overall (relative risk 1.04, 95%CI 0.98–1.11); cardiovascular malformations (relative risk 1.07, 95%CI 0.96–1.20); or central nervous system malformations (relative risk 1.06, 95%CI 0.92–1.21). Raised risk estimates were observed for gastrointestinal malformations (relative risk 1.40, 95%CI 0.38–5.16) and cleft palate (relative risk 1.57, 95%CI 0.48–5.13) following any opioid exposure and atrial septal defects (relative risk 1.20, 95%CI 1.05–1.36) following codeine exposure. Conclusions: Although the meta‐analysis did not indicate substantial increased risk for most malformations examined, this risk remains uncertain due to the methodological limitations of the included studies. Healthcare professionals and pharmaceutical regulators should be aware of the issues related to the quality of research in this field. [ABSTRACT FROM AUTHOR]

Background: The Medicines Intelligence (MedIntel) Data Platform is an anonymised linked data resource designed to generate real‐world evidence on prescribed medicine use, effectiveness, safety, costs and cost‐effectiveness in Australia. Results: The platform comprises Medicare‐eligible people who are ≥18 years and residing in New South Wales (NSW), Australia, any time during 2005–2020, with linked administrative data on dispensed prescription medicines (Pharmaceutical Benefits Scheme), health service use (Medicare Benefits Schedule), emergency department visits (NSW Emergency Department Data Collection), hospitalisations (NSW Admitted Patient Data Collection) plus death (National Death Index) and cancer registrations (NSW Cancer Registry). Data are currently available to 2022, with approval to update the cohort and data collections annually. The platform includes 7.4 million unique people across all years, covering 36.9% of the Australian adult population; the overall population increased from 4.8 M in 2005 to 6.0 M in 2020. As of 1 January 2019 (the last pre‐pandemic year), the cohort had a mean age of 48.7 years (51.1% female), with most people (4.4 M, 74.7%) residing in a major city. In 2019, 4.4 M people (73.3%) were dispensed a medicine, 1.2 M (20.5%) were hospitalised, 5.3 M (89.4%) had a GP or specialist appointment, and 54 003 people died. Anti‐infectives were the most prevalent medicines dispensed to the cohort in 2019 (43.1%), followed by nervous system (32.2%) and cardiovascular system medicines (30.2%). Conclusion: The MedIntel Data Platform creates opportunities for national and international research collaborations and enables us to address contemporary clinically‐ and policy‐relevant research questions about quality use of medicines and health outcomes in Australia and globally. [ABSTRACT FROM AUTHOR]

Background Epithelial ovarian cancer (EOC) is the eighth most common cancer in women, with poor survival outcomes. Observational evidence suggests that nitrogen-based bisphosphonate (NBB) use may be associated with reduced risk of EOC, particularly the endometrioid and serous histotypes; however, confounding by indication is a concern. An alternative approach to investigate the chemo-preventive potential of NBBs is to emulate a target trial by identifying all women who initiate use of NBBs and investigate the risk of EOC for continued users compared with discontinued users. Methods Using population-based linked data, we identified all Australian women aged over 50 years who first used NBBs over 2004–12. We used the year after first use to define treatment for each woman as either continued or discontinued use. We emulated randomization using stabilized inverse probability weights to balance the treatment groups using covariates including age, comorbidities and socioeconomic status. We followed women from treatment assignment until EOC diagnosis, death or 31 December 2013. We assessed the risk of EOC (overall and by histotype) using flexible parametric time-to-event models allowing for time-varying effects, and produced time-varying coefficients. Results Of the 313 383 women in the study, 472 were diagnosed with EOC during follow-up (261 serous EOC), with an average age at diagnosis of 72 years. Continued use of NBBs was associated with reduced risk of EOC overall (HR = 0.87, 95% CI: 0.69, 1.10), and serous EOC (HR = 0.71, 95% CI: 0.53, 0.96), compared with discontinued treatment, with estimates remaining constant over the 9-year follow-up. Conclusions Results from our emulated trial suggest that in women who initiated NBB treatment, those who continued use had 13% and 29% lower hazards of being diagnosed with EOC overall and serous EOC, respectively, compared with women who discontinued use. [ABSTRACT FROM AUTHOR]

Background/Obectives: Oral retinoids are teratogenic, and pregnancy avoidance is an important part of retinoid prescribing. Australia does not have a standardised pregnancy prevention programme for women using oral retinoids, and the contraception strategies for women who use oral retinoids are not well understood. The objectives were to determine trends in the use of prescription retinoids among Australian reproductive‐aged women and whether women dispensed oral retinoids used contraception concomitantly. Methods: This was a population‐based study using Australian Pharmaceutical Benefits (PBS) dispensing claims for a random 10% sample of 15‐44‐year‐old Australian women, 2013 ‐ 2021. We described rates and annual trends in dispensing claims for PBS‐listed retinoids and contraceptives. We also estimated concomitant oral retinoid and contraceptive use on the day of each retinoid dispensing and determined if there was a period of contraceptive treatment that overlapped. Estimates were then extrapolated to the national level. Results: There were 1,545,800 retinoid dispensings to reproductive‐aged women; 57.1% were oral retinoids. The rate of retinoid dispensing to reproductive‐aged women increased annually, from 28 dispensings per 1000 population in 2013 to 41 per 1000 in 2021. The rate of oral retinoid dispensing doubled over the study period, from 14 dispensings per 1000 population in 2013 to 28 per 1000 in 2021, while topical retinoid dispensing did not change. Only 25% of oral retinoid dispensings had evidence of concomitant contraceptive use in 2021. Conclusions: Rates of oral retinoid dispensing have doubled among reproductive‐aged women over the past decade. A large percentage of oral retinoid use does not appear to have concomitant contraception use, posing a risk of teratogenic effects in pregnancies. [ABSTRACT FROM AUTHOR]

Aims: Oxycodone is the most commonly prescribed strong opioid in Australia. This study describes health service antecedents and sociodemographic factors associated with oxycodone initiation. Methods: Population‐based new user cohort study linking medicine dispensings, hospitalizations, emergency department visits, medical services and cancer notifications from New South Wales (NSW) for 2014–2018. New users had no dispensings of any opioid in the preceding year. We analysed health service use in the 5 days preceding initiation and proportion of people on treatment over 1 year and fitted an area‐based, multivariable initiation model with sociodemographic covariates. Results: Oxycodone accounted for 30% of opioid initiations. Annually, 3% of the NSW population initiated oxycodone, and 5–6% were prevalent users; the new user cohort comprised 830 963 people. Discharge from hospital (39.3%), therapeutic procedures (21.4%) and emergency department visits (19.7%) were common; a hospital admission for injury (6.0%) or a past‐year history of cancer (7.2%) were less common. At 1 year after initiation, 4.6% of people were using oxycodone. In the multivariable model, new use of oxycodone increased with age and was higher for people outside major cities, for example, an incidence rate ratio of 1.43 (95% confidence interval 1.36–1.51) for inner regional areas relative to major cities; there was no evidence of variation in rates of new use by social disadvantage. Conclusion: About half of new oxycodone use in NSW was preceded by a recent episode of hospital care or a therapeutic procedure. Higher rates of oxycodone initiation in rural and regional areas were not explained by sociodemographic factors. [ABSTRACT FROM AUTHOR]

Background and Aim: People with new‐onset diabetes mellitus (diabetes) could be a possible target population for pancreatic cancer surveillance. However, distinguishing diabetes caused by pancreatic cancer from type 2 diabetes remains challenging. We aimed to develop and validate a model to predict pancreatic cancer among women with new‐onset diabetes. Methods: We conducted a retrospective cohort study among Australian women newly diagnosed with diabetes, using first prescription of anti‐diabetic medications, sourced from administrative data, as a surrogate for the diagnosis of diabetes. The outcome was a diagnosis of pancreatic cancer within 3 years of diabetes diagnosis. We used prescription medications, severity of diabetes (i.e., change/addition of medication within 2 months after first medication), and age at diabetes diagnosis as potential predictors of pancreatic cancer. Results: Among 99 687 women aged ≥ 50 years with new‐onset diabetes, 602 (0.6%) were diagnosed with pancreatic cancer within 3 years. The area under the receiver operating curve for the risk prediction model was 0.73. Age and diabetes severity were the two most influential predictors followed by beta‐blockers, acid disorder drugs, and lipid‐modifying agents. Using a risk threshold of 50%, sensitivity and specificity were 69% and the positive predictive value (PPV) was 1.3%. Conclusions: Our model doubled the PPV of pancreatic cancer in women with new‐onset diabetes from 0.6% to 1.3%. Age and rapid progression of diabetes were important risk factors, and pancreatic cancer occurred more commonly in women without typical risk factors for type 2 diabetes. This model could prove valuable as an initial screening tool, especially as new biomarkers emerge. [ABSTRACT FROM AUTHOR]

Background: Sustained‐release (SR) tapentadol was listed on Australia's Pharmaceutical Benefits Scheme (PBS) in 2014 for chronic severe pain requiring long‐term opioid treatment. Dispensings have increased since listing despite declining trends in other PBS‐listed opioids. Preferential prescribing of SR opioids may increase the risk of dependence and accidental overdose, particularly when used to treat acute pain. Aims: To explore the quality use of publicly subsidised tapentadol in Australia. Methods: We examined annual initiation rates and patterns of use of tapentadol (SR) in the dispensing records of a 10% random sample of PBS‐eligible Australians (2014–2021). We used national tapentadol sales data to assess the proportion of sales attributable to the PBS. Results: Tapentadol initiation increased from 2014, peaking at 7.5/1000 adult population in 2019 before declining to 5.3/1000 in 2021. We identified 63 766 new users between 2014 and 2020, of whom 92.8% discontinued in the first year following initiation, 58.0% had only a single dispensing and 34.3% had no other opioids dispensed in the 3 months before or after initiation. 27.8% of new users were dispensed tapentadol on the same day as potentially interacting medicines. There was a sustained drop in the proportion of sales attributable to the PBS from June 2020 onwards, from an average of 69.1%, to 63.9% of pack sales. Conclusions: Patterns of use suggest tapentadol (SR) is generally used for short duration. Although most tapentadol sold in Australia is subsidised, there is evidence of a shift towards private sales. [ABSTRACT FROM AUTHOR]

BACKGROUND: The SSaSS (Salt Substitute and Stroke Study) has shown that use of a potassium-enriched salt lowers the risk of stroke, total cardiovascular events, and premature death. The effects on cause-specific cardiac outcomes are reported here. METHODS: SSaSS was an unblinded, cluster-randomised trial assessing the effects of potassium-enriched salt compared with regular salt among 20 995 Chinese adults with established stroke and older age and uncontrolled hypertension. Post hoc efficacy analyses were performed using an intention-to-treat method and a hierarchical Poisson regression model adjusting for clustering to obtain rate ratios and 95% CIs. We assessed acute coronary syndrome, heart failure, arrhythmia, and sudden death. RESULTS: Over a mean 4.74 years follow-up, there were 695 acute coronary syndrome events, 454 heart failure events, 230 arrhythmia events, and 1133 sudden deaths recorded. The rates of events were lower in potassium-enriched salt group for all outcomes but CIs were wide for most: acute coronary syndrome (6.32 versus 7.65 events per 1000 person-years; rate ratio, 0.80 [95% CI, 0.65–0.99]); heart failure (9.14 versus 11.32 events per 1000 person-years; rate ratio, 0.88 [95% CI, 0.60–1.28]); arrhythmia (4.43 versus 6.20 events per 1000 person-years; rate ratio, 0.59 [95% CI, 0.35–0.98]); and sudden death (11.01 versus 11.76 events per 1000 person-years; rate ratio, 0.94 [95% CI, 0.82–1.07]; all P >0.05 with adjustment for multiple comparisons). CONCLUSIONS: These results suggest that use of potassium-enriched salt is more likely to prevent than cause cardiac disease but the post hoc nature of these analyses precludes definitive conclusions. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02092090. [ABSTRACT FROM AUTHOR]

Background: We investigated differences in cumulative incidence of first distant recurrence (DR) following non-metastatic breast cancer over a time period when new adjuvant therapies became available in Australia. Methods: We conducted a health record linkage study of females with localized (T1-3N0) or regional (T4 or N+) breast cancer in the New South Wales Cancer Registry in 2001 to 2002 and 2006 to 2007. We linked cancer registry records with administrative records from hospitals, dispensed medicines, radiotherapy services, and death registrations to estimate the 9-year cumulative incidence of DR and describe use of adjuvant treatment. Results: The study included 13,170 women (2001-2002 n = 6,338, 2006-2007 n = 6,832). The 9-year cumulative incidence of DR was 3.6% [95% confidence interval (CI), 2.3%-4.9%] lower for 2006-2007 diagnoses (15.0%) than 2001-2002 (18.6%). Differences in the annual hazard of DR between cohorts were largest in year two. DR incidence declined for localized and regional disease. Decline was largest for ages <40 years (absolute difference, 14.4%; 95% CI, 8.3%-20.6%), whereas their use of adjuvant chemotherapy (2001-2002 49%, 2006-2007 75%) and HER2-targeted therapy (2001-2002 0%, 2006-2007 16%) increased. DR did not decline for ages =70 years (absolute difference, 0.9%; 95% CI, -3.6%-1.8%) who had low use of adjuvant chemotherapy and HER2-targeted therapy. Conclusions: This whole-of-population study suggests that DR incidence declined over time. Decline was largest for younger ages, coinciding with changes to adjuvant breast cancer therapy. [ABSTRACT FROM AUTHOR]

Aims Methods Results Conclusions The aim of this study was to examine contemporary trends in the use of, time to, and type of first add‐on anti‐hyperglycaemic therapy to metformin in Australia.We used the dispensing records of a 10% random sample of Pharmaceutical Benefits Scheme (PBS) eligible people. We included people aged 40 years and older initiating metformin from 1 January 2018 to 31 December 2020. Our primary outcome was first add‐on anti‐hyperglycaemic medicine within 2 years of metformin initiation. We analysed time to dispensing of first add‐on therapy. All analyses were stratified by metformin initiation year.Overall, 38 747 people aged 40 years and older initiated metformin between 2018 and 2020. Approximately one‐third (n = 12 946) of people received add‐on therapy with the proportion increasing slightly by year of metformin initiation (32.3% in 2018 to 34.8% in 2020). Amongst people with add‐on therapy following metformin initiation, sodium‐glucose cotransporter 2 inhibitor (SGLT2i) use increased from 28.8% (2018) to 35.0% (2020), and glucagon‐like peptide‐1 receptor agonists (GLP‐1 RA) increased from 3.0% to 9.6%, respectively. Dipeptidyl peptidase‐4 inhibitors and sulfonylureas as first add‐on therapy decreased and insulin remained stable. One‐third of people with add‐on therapy initiated the therapy on the same day metformin was initiated, i.e. initial combination therapy.Amongst people initiating metformin from 2018 to 2020, there was an increasing proportion of SGLT2i and GLP‐1 RA being used as first add‐on therapy. However, the overall prevalence of add‐on therapy was low. Advocacy to promote add‐on therapy with cardiorenal beneficial medicines is critical to reduce type 2 diabetes morbidity and mortality. [ABSTRACT FROM AUTHOR]

Summary: Background: Prescribed opioid analgesics are frequently used to manage pain in pregnancy. However, the available literature regarding the teratogenic potential of opioid use during pregnancy has not been systematically summarised. This systematic review and meta‐analysis aimed to assess the quality of the evidence on these potential risks and calculate a pooled estimate of risk for any opioid analgesic and individual opioids. Methods: We searched PubMed, Embase and CINAHL for published studies assessing the risk of major congenital malformations in infants following first‐trimester exposure to opioid analgesics compared with a reference group, excluding studies examining opioid agonist therapy or illicit opioid use. We assessed the risk of bias using the Risk of Bias in Non‐Randomised Studies of Intervention tool. We pooled adjusted risk estimates from studies rated at serious risk of bias or better in a random‐effects meta‐analysis. Results: Of 12 identified studies, 11 were at high risk of bias (eight serious; three critical). Relative to unexposed infants, those exposed to any opioid use during the first trimester of pregnancy were not at an increased risk of major congenital malformations overall (relative risk 1.04, 95%CI 0.98–1.11); cardiovascular malformations (relative risk 1.07, 95%CI 0.96–1.20); or central nervous system malformations (relative risk 1.06, 95%CI 0.92–1.21). Raised risk estimates were observed for gastrointestinal malformations (relative risk 1.40, 95%CI 0.38–5.16) and cleft palate (relative risk 1.57, 95%CI 0.48–5.13) following any opioid exposure and atrial septal defects (relative risk 1.20, 95%CI 1.05–1.36) following codeine exposure. Conclusions: Although the meta‐analysis did not indicate substantial increased risk for most malformations examined, this risk remains uncertain due to the methodological limitations of the included studies. Healthcare professionals and pharmaceutical regulators should be aware of the issues related to the quality of research in this field. [ABSTRACT FROM AUTHOR]

Background: Prescribed medicines are commonly used to treat mental health conditions but are also often implicated in suicide death by poisoning. This was a descriptive study quantifying changes in dispensing and initiation of antidepressants, benzodiazepines, and antipsychotics in the year prior to death by suicide., Methods: In this Australian population-based case series, we used national coronial data linked with dispensing claims for all people ≥10 years who died by suicide (2013-2019). Our primary outcome was change in aggregate weekly medicine dispensing the year before death, quantified using piecewise linear regression stratified by cause of death (medicine poisoning vs other causes). Our secondary outcome was change in medicine initiation rates. This study was performed between June 2021 and July 2023., Findings: Our study included 14,207 people (24% female, median age 44  years). In the year prior to death, we observed higher rates of nervous system medicine use in people who died by medicine poisoning compared with those that did not: antidepressants (62.4% vs 42.9%), benzodiazepines (51.4% vs 29.0%), antipsychotics (25.6% vs 17.1%), opioids (43.8% vs 23.4%). For benzodiazepines, among people who died by medicine poisoning the slope (rate of increase) changed from 0.18 (95% CI -0.01, 0.37) to 4.12 (95% CI 0.98, 7.26) dispensings per 1000 people per week at 8 weeks prior to death. Among people who died of other causes, the slope changed from 0.18 (95% CI 0.14, 0.22) to 2.41 (95% CI 1.90, 2.91) also at 8 weeks prior to death. For antidepressants, among people who died of medicine poisoning we observed no change in the slope. Among people who died of other causes, the slope increased from 0.18 (95% CI 0.09, 0.28) to 1.68 (95% CI 1.20, 2.15) at 14 weeks prior to death., Interpretation: Dispensing of antidepressants and benzodiazepines increased more rapidly closer to date of death, regardless of medicine involvement in death. This suggests these changes may reflect worsening symptoms or increased help seeking and that the method of death by suicide may be due to greater means access. However, findings need to be interpreted with caution as our analyses were performed on aggregate data and may not reflect person-level changes., Funding: This study is funded by a grant from the Australian National Health and Medical Research Council (NHMRC) and the Translational Australian Clinical Toxicology Research (TACT) Group., Competing Interests: RC is named on an untied educational grant from Reckitt to study over-the-counter medicines poisoning. RC also received an honorarium and travel costs from Reckitt to present educational information on poisoning prevention at a conference, and an honorarium from the Pharmacy Guild of Australia to present at a conference. These are unrelated to the present work. JSL received support from the Australian Government Research Training Program scholarship., (© 2024 The Authors.)

Background: Dual antiplatelet therapy with P2Y12 inhibitors (P2Y12i) and aspirin following acute myocardial infarction (AMI) prevents future ischaemic events. People with atrial fibrillation (AF) also require oral anticoagulants (OAC), increasing bleeding risk. Guidelines recommend post-discharge prescribing of direct OAC with clopidogrel and discontinuation of P2Y12i after 12 months, but little is known about use in clinical practice., Aim: To describe post-discharge use of OACs and P2Y12i in people with AF and a history of OAC use hospitalised for AMI., Methods and Results: We identified 1,330 people hospitalised for AMI with a diagnosis of AF and history of OAC use in New South Wales, Australia, July 2018-June 2020. We identified three aspects of post-discharge antithrombotic medicine use with possible safety implications: (1) not being dispensed OACs; (2) dispensing OAC and P2Y12i combinations associated with increased bleeding (involving warfarin, ticagrelor or prasugrel); and (3) P2Y12i use longer than 12 months.After discharge, 74.3% of people were dispensed an OAC, 45.4% were dispensed a P2Y12i, and 35.8% were dispensed both. People with comorbid heart failure or cancer were less likely to receive OACs. Only 11.2% of people dispensed both an OAC and P2Y12i received combinations associated with increased bleeding; this was more common among people with chronic kidney disease or prior warfarin or statin use. 44.6% of people dispensed both medicines continued P2Y12i for over 12 months; this was more common in people who received a revascularisation or lived in areas of social disadvantage., Conclusion: We identified potential gaps in pharmacotherapy, including underuse of recommended therapies at discharge, use of combinations associated with increased bleeding, and P2Y12i use beyond 12 months. Prescribing vigilance across both hospital and community care is required., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Early evidence on COVID-19 vaccine efficacy came from randomised trials. Many important questions subsequently about vaccine effectiveness (VE) have been addressed using real-world studies (RWS) and have informed most vaccination policies globally. As the questions about VE have evolved during the pandemic so have data, study design, and analytical choices. This scoping review aims to characterise this evolution and provide insights for future pandemic planning-specifically, what kinds of questions are asked at different stages of a pandemic, and what data infrastructure and methods are used?, Methods and Analysis: We will identify relevant studies in the Johns Hopkins Bloomberg School of Public Health VIEW-hub database, which curates both published and preprint VE RWS identified from PubMed, Embase, Scopus, Web of Science, the WHO COVID Database, MMWR, Eurosurveillance, medRxiv, bioRxiv, SSRN, Europe PMC, Research Square, Knowledge Hub, and Google. We will include RWS of COVID-19 VE that reported COVID-19-specific or all-cause mortality (coded as 'death' in the 'effectiveness studies' data set).Information on study characteristics; study context; data sources; design and analytic methods that address confounding will be extracted by single reviewer and checked for accuracy and discussed in a small group setting by methodological and analytic experts. A timeline mapping approach will be used to capture the evolution of this body of literature.By describing the evolution of RWS of VE through the COVID-19 pandemic, we will help identify options for VE studies and inform policy makers on the minimal data and analytic infrastructure needed to support rapid RWS of VE in future pandemics and of healthcare strategies more broadly., Ethics and Dissemination: As data is in the public domain, ethical approval is not required. Findings of this study will be disseminated through peer-reviewed publications, conference presentations, and working-papers to policy makers., Registration: https://doi.org/10.17605/OSF.IO/ZHDKR., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

This cohort profile describes one of the largest linked datasets in the world concerning the health of people with intellectual disability. The cohort comprises a retrospective group of 100,089 individuals with intellectual disability who received disability and/or health services in New South Wales, Australia. Of these participants, 34% were female, with a median age at cohort entry of 3 years (interquartile range, 0-19). A separate comparator cohort included 455,677 individuals, matched by 5-year age group, sex, and residential postcode at a 5:1 ratio. Initial results indicate that between 2001 and 2018, people with intellectual disability experienced more than double the rate of hospitalisations (538 vs. 235 per 1,000 person-years), as well as markedly higher rates of emergency department presentations (707 vs. 379 per 1,000 person-years) and use of ambulatory mental health services (1,012 vs. 157 per 1,000 person-years), relative to the comparator cohort. The largest disparities in hospital admissions were for mental disorders, dialysis, and diseases of the nervous system and sense organs. Furthermore, individuals with intellectual disability had more than double the rate of dispensed medications found in the comparator cohort. Of these medications, 46.6% were for the treatment of nervous system conditions, as opposed to 24.7% for the comparator cohort. The mean±standard deviation age at death was 52±19 years for people with intellectual disability and 64±22 years for the comparator participants.