Search Results for: GPG: Versione 5.7.5 (Novembre 2021)

Background
This study addresses the limited evidence of the impact of product characteristics on demand for and the substitutability of electronic cigarettes (e-cigarettes) or heated tobacco products for combusted cigarettes among people who smoke and have newly begun to use e-cigarettes.

Methods
A sample of 318 adults who smoke and recently initiated/reinitiated e-cigarette use participated in an online volumetric choice experiment in 2020–2021 to assess stated preferences for consumption and own and cross-price elasticities of three e-cigarette options (cig-a-like, vape pen or tank, closed pod system), heated tobacco product (IQOS) and their usual brand of cigarettes. Product attributes manipulated were price, flavour, level of harm, how well the product reduces cravings to smoke, and how discretely the product can be used. Multilevel zero-inflated negative binomial models were used to model the purchased quantities.

Results
Cigarettes were preferred over all alternatives. However, demand for cig-a-likes, but not IQOS, increased when cigarette prices were higher. Higher prices for e-cigarettes and IQOS did not increase demand for cigarettes. The odds of buying e-cigarettes/IQOS were higher when their harm was stated as low or unknown versus being similar to cigarettes (ie, very high). Other attributes (including various flavour options) were not significantly associated with demand for e-cigarettes or IQOS.

Conclusions
People who smoke and recently began using e-cigarettes might substitute cig-a-likes for cigarettes when cigarette prices are higher. Policies to increase the cost of combusted cigarettes as well as communicate lower relative harm and low absolute harm of e-cigarettes may facilitate switching behaviour.

Objectives
This study aims to determine the association between loneliness and depression, anxiety and anger with a representative sample of the general population in Korea, which are the most prevalent mental health problems during the pandemic.

Design
Cross-sectional study.

Setting
National survey across all 17 provinces in South Korea between December 2021 and January 2022.

Participants
We conducted a national survey on 2699 participants aged 19–84 years using proportional stratified sampling. Using the UCLA Loneliness Scale and standardised questionnaires for depression (Patient Health Questionnaire-9), anxiety (Generalised Anxiety Disorder-7) and anger (Patient-Reported Outcomes Measurement Information System-Anger), we explored the prevalence and association of loneliness with these mental health outcomes.

Primary and secondary outcome measures
Primary outcomes included the prevalence and co-occurrence of depression, anxiety and anger across different levels of loneliness.

Results
Of total, 20.7% and 2.1% experienced moderately high and high levels of loneliness, respectively. Among participants with high levels of loneliness, 11.8%, 5.9% and 11.8% had depression, anxiety and anger, respectively, and 28.7% of them had depression, anxiety and anger together. The adjusted prevalence of depression was 0.2 (95% CI 0.0 to 0.5), 8.2 (95% CI 6.7 to 9.7), 31.3 (95% CI 27.4 to 35.3) and 63.5 (95% CI 50.1 to 76.8) for low, moderate, moderately high and high levels of loneliness, respectively. Similarly, increased adjusted prevalence of anxiety and anger was observed ㅈwith higher levels of loneliness.

Conclusions
Lonely people have a higher risk of depression, anxiety and anger. Identifying individuals who may be vulnerable to loneliness is important for early intervention.

Stroke, Ahead of Print. BACKGROUND:While the efficacy of statins, which are cholesterol-lowering agents, in preventing subarachnoid hemorrhage (SAH) has been examined in experimental animal models and some clinical studies, findings remain inconclusive. This study aimed to investigate the association between statin use and the risk of SAH.METHODS:We conducted a large population-based case-control study using data from the Japanese Health Insurance Claims Database from January 2005 to August 2021. This nationwide database includes the data of individuals aged 0 to 74 years. Cases were defined as patients hospitalized with a first diagnosis of SAH (International Classification of Diseases, Tenth Revisioncode I60) during this period. Four controls per case were randomly selected and matched by age, sex, and follow-up period using incidence density sampling. Statin exposure (use, recency, and duration) was evaluated before the incidence of SAH. Conditional logistic regression, adjusted for patient characteristics, was used to assess the association between statin use and SAH risk. We also investigated whether this association varies with a history of hypertension, diabetes, cerebrovascular disease, unruptured intracranial aneurysms, and the use of antihypertensive medications.RESULTS:The study identified 3498 cases and 13 992 matched controls. Statin use was reported in 12.2% of SAH cases and 12.7% of the controls. After adjusting for patient characteristics, statin use was associated with a significantly reduced risk of SAH (adjusted odds ratio, 0.81 [95% CI, 0.69–0.95]). The association was significantly influenced by a history of hypertension or cerebrovascular disease (Pinteraction=0.042 and 0.042, respectively).CONCLUSIONS:Statin use was significantly associated with a reduced risk of SAH. These findings suggest that statins may play a role in the prevention of SAH, particularly in patients with a history of hypertension or cerebrovascular disease.

Background
Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.

Methods
A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).

Ethics and dissemination
This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.

Trial registration numbers
Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).

Introduction
The National Family Health Survey-5 has reported an under-five mortality rate of 41.9 per 1000 live births in India. Pneumonia, one of the leading causes of under-five mortality, contributes substantially to this figure. The Indian government has made efforts through multiple national programmes, but pneumonia-specific mortality remains high. The Government of India revised their Childhood Pneumonia Management Guidelines in 2019 to improve under-five pneumonia prevention and management. This implementation study aims to achieve a high population-based coverage of pneumonia treatment for under 5 yearold children in the Palwal district of India.

Method and analysis
This implementation study uses a quasi-experimental pre-post design and a mixed-methods approach, conducted in three phases: (i) formative research, (ii) model optimisation through iterative testing in a learning block and (iii) scale-up and concurrent evaluation. The study is set in Palwal district, Haryana, and the primary catchment/study area will be the Health and Wellness Centres, the most accessible public health facilities for the community. Approximately 4167 households will be surveyed to capture ~2400 under-five children, among whom about 120 pneumonia cases (based on an estimated 5% prevalence) will be included in the analysis of treatment coverage and outcomes. Quantitative data will be analysed using descriptive statistics and generalised linear models, while qualitative data from focus group discussions and in-depth interviews will be thematically analysed using NVivo software.

Ethics and dissemination
Ethical approval was granted by the ethical committees of the Society for Applied Studies (ERC/IR Pneumonia/2021), the Regional Ethics Committee of Western Norway (2022/531608) and the WHO(ERC.0003652). Additionally, this study has obtained the Government of Haryana state (Memo no. HSHRC/2022/505) and Health Ministry steering committee (approval date: 19 Dec 2022, proposal id 2022–17596) approvals. Informed consent will be obtained from all participants, including caregivers and healthcare workers, prior to data collection. Dissemination meetings in the study country will share results with stakeholders, including Ministry of Health officials, health managers, families of under-five children, community leaders and academia, to discuss national health programme implications. Results will also be shared regionally and globally, with publications and presentations encouraged in national and international forums.

Study registration
Clinical Trials Registry – India, CTRI/2021/03/031622.

Objectives
Infective endocarditis (IE) is a global public health challenge, and our understanding of its temporal evolution in China compared with the Group of Twenty (G20) countries remains limited. This study aims to analyse the disease burden of IE in China from 1990 to 2021, forecast trends for the next 15 years and compare the findings with those in G20 countries.

Design
Observational study.

Setting
The data of 20 countries and regions in G20 were obtained from the Global Burden of Disease (GBD) Study 2021.

Participants
Data were publicly available and individuals were not involved.

Main outcome measures
Using data from the GBD 2021, we collected incidence, disability-adjusted life-years (DALYs) and age-standardised rates for both China and G20 countries. Temporal trends were assessed using the estimated annual percentage change (EAPC) and a joinpoint regression analysis was conducted to pinpoint periods of significant change. Additionally, a decomposition analysis was performed to identify the factors driving changes. Finally, the Bayesian age-period-cohort model was used to forecast trends for the next 15 years.

Results
In 2021, there were 264 282 (95% UI: 216 083 to 315 405) incident cases of IE in China, resulting in 49 925 (95% UI: 38 779 to 69 119) DALYs. The age-standardised incidence rate (ASIR) and age-standardised DALY rate (ASDR) were 14.38 (95% UI: 12.03 to 16.92) and 3.46 (95% UI: 2.65 to 5.01) per 100 000 population, respectively, with both rates being higher in males than in females. Notably, both ASIR and ASDR showed a pattern of first decreasing and then increasing with age, with the highest values observed in the age group of 95 years and above. From 1990 to 2021, the ASIR of IE in China showed a slow upward trend (EAPC: 0.49, 95% CI: 0.44 to 0.55), which was lower than the average level among G20 countries. In contrast, the ASDR exhibited a significant downward trend (EAPC: –6.26, 95% CI: –6.8 to –5.71), representing the largest decline among the G20 countries. The most notable increase in ASIR occurred from 1995 to 2005 in both China and the G20. The greatest decrease in ASDR was observed in China between 2001 and 2004 and in the G20 between 2018 and 2021. Projections suggest that over the next 15 years, the ASIR for both males and females in China will continue to rise, while the ASDR will show a declining trend.

Conclusions
In China, the incidence of IE-related diseases has steadily increased across both genders, despite a declining trend in DALYs. Compared with G20 countries, China’s age-standardised burden of IE is relatively low, yet the large increasing number of cases should not be underestimated. Therefore, establishing effective prevention and treatment strategies is crucial to alleviating the future burden of IE.

Objectives
Cancer patients often experience psychological distress, while optimism has been identified as a protective factor. However, the mental health of postradiotherapy cancer survivors and its association with optimism remain largely unexplored. This study assesses the mental health status and optimism levels of postradiotherapy cancer survivors and evaluates their associations.

Design
Cross-sectional survey study.

Participants
114 Hong Kong cancer survivors who (1) were aged 18 years or above and (2) had received radiotherapy for their cancer treatment and finished the radiotherapy within the previous 3 years (2021–2024).

Outcome measures
Mental health was assessed using the Chinese Depression, Anxiety and Stress Scale, and optimism was measured using the Revised Life Orientation Test. Correlation and regression analyses were used to examine the associations between these measures.

Results
Participants reported overall low optimism with mild to moderate depression, anxiety and stress. Strong negative correlations were identified between optimism and depression (r=–0.833, p

Objective
This study aimed to assess high-risk human papillomavirus (HPV) infection (HPV 16/18) and its determinants among women in East Gojjam Zone, Northwest Ethiopia.

Design
An institutional-based cross-sectional study.

Setting and participants
The study was conducted among 337 women screened for cervical cancer in two hospitals in East Gojjam Zone from February to April 2021 gregoriean calander.

Results
The prevalence of HPV infection was 14.2% (95% CI: 10.7% to 18.1%). The mean age of the respondents was 36.7±9.1 years. Women in the age group of 55–65 years (adjusted OR (AOR)=7.91, 95% CI: 1.95 to 32.09), early initiation of sexual intercourse (AOR=5.36, 95% CI: 1.58 to 18.13), history of sexually transmitted infection (STI) (AOR=3.52, 95% CI: 1.27 to 9.72), HIV positive status (AOR=6.8, 95% CI: 1.99 to 23.54) and number of lifetime sexual partners (AOR=4.37, 95% CI: 1.15 to 17.3) were important independent factors associated with the presence of oncogenic HPV infection.

Conclusion and recommendation
We found a relatively low prevalence of high-risk HPV infection. Age, early initiation of sexual intercourse at less than 18 years, history of STI, being HIV seropositive and multiple sexual partners were important factors for high-risk HPV infection. Women aged >46 years, women with early initiation of sex, a history of STI, being HIV positive and a history of multiple sexual partners should be encouraged to be screened and vaccinated for HPV infection. Wider-ranging studies are also needed in HPV-infected women in association with the cervical lesion.

Objective
This study aimed to evaluate the utility of optical sensor-based technology in mitigating the frequency and severity of peripheral intravenous infiltration and/or extravasation (PIVIE) in neonates.

Design
Single-centre, retrospective, observational cohort study.

Setting
Tertiary-level neonatal intensive care unit (NICU) (112 cots) at the Women’s Wellness and Research Centre (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar, January 2019–December 2022.

Participants
All neonates admitted to the NICU requiring intravenous therapy via a neonatal short peripheral intravenous catheter (n-SPC) were included. Participants were excluded if the insertion was unsuccessful, if they had incomplete data, or if they received intravenous therapy exclusively through alternative vascular access devices.

Interventions
The study analysed two cohorts representing different clinical practices over two distinct periods. In the conventional cohort (Phase 1, 2019–2020), PIVIE detection relied solely on periodic ‘Touch Look Compare (TLC)’ assessments. In the ivWatch cohort (Phase 2, 2021–2022), continuous optical sensor-based monitoring using the ivWatch system was implemented alongside TLC assessments. This sequential design allowed for a comparison of outcomes between the two phases.

Outcome measurements
The primary outcomes were the occurrence and severity of PIVIE. Secondary outcomes included the influence of patient demographics, vascular access characteristics, and management details on PIVIE incidence and severity.

Results
Over the 4-year data collection period, 32 713 peripheral intravenous catheters were analysed across two cohorts. PIVIE was the most common reason for unplanned device removal. In the conventional cohort (Phase 1, 2019–2020), 4941 infiltration events were reported (29.9%), compared with 4872 events (30.1%) in the ivWatch cohort (Phase 2, 2021–2022). However, severity measures using the Intravenous Extravasation Grading Scale (IEGS) revealed a marked reduction in severe PIVIE cases, with severe events decreasing from 243 (4.9%) in the conventional cohort to 54 (1.1%) in the ivWatch cohort (p

Objectives
For several decades, mortality has decreased more rapidly among individuals with a higher socioeconomic position than among those with a lower position. This widening social inequality gap has increasingly been recognised as an important aspect of public health research and policies. The objective of this study was to examine trends in educational inequality in healthy life expectancy (HLE) in Denmark between 2010 and 2021 at the age of 30 years.

Design
The study is a population-based study based on register data on longest attained education, standard life tables and self-reported health information from nationwide health surveys.

Setting
The study is conducted among the general adult population in Denmark.

Participants
Participants include respondents from the Danish National Health Survey and the Danish Health and Morbidity Survey in 2010, 2013, 2017 and 2021 aged ≥30 years.

Primary and secondary outcome measures
Expected lifetime in good self-rated health, with no long-standing illness and with no activity limitations was estimated by Sullivan’s method, and educational inequality was expressed by the Slope Index of Inequality.

Results
Between 2010 and 2021, educational inequality in HLE increased among both men and women for long-standing illness (5-year trend: +1.1 and +1.2 years) and activity limitations (+2.4 and +2.6 years) but remained stable among men (+0.1 year) and decreased among women (–0.3 year) for self-rated health. For the latter two indicators, the inequality gap narrowed after 2017.

Conclusion
Trends in educational inequality in HLE in Denmark 2010–2021 vary by health indicator. Steadily widening gaps were demonstrated for long-standing illness, while narrowing gaps were seen after 2017 for activity limitations and self-rated health. Future studies are encouraged to explore potential health risk behaviours that may explain or modify these inequality trends.

This study describes trends in private equity ownership of psychiatric hospitals from 2013 through 2021 and the cross-sectional association between private equity ownership and hospital staffing and quality.

Introduction
Breast cancer survival rates in low-income and middle-income countries significantly differ from those in high-income countries, indicating limited access to first-line systemic therapy for advanced and metastatic tumours. Recent studies have demonstrated the benefits of combining cyclin-dependent kinase 4 and 6 inhibitors (CDK 4/6) with endocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. However, in Brazil, the population faces limited access to these drugs, particularly in the public healthcare system.

Methods and analysis
This prospective observational study will enrol 300 female patients from 20 cancer centres across Brazil, divided into two groups based on healthcare coverage: those treated in the public healthcare system (group 1) and those treated in the private healthcare system (group 2). The use or non-use of CDK 4/6 inhibitors is not dictated by the study protocol but rather reflects real-world treatment decisions made by attending physicians. Patients will be followed for 24 months, stratified according to CDK 4/6 inhibitor usage. The project aims to assess health inequities by evaluating the prognosis of patients treated in the public versus private healthcare systems. Outcomes include progression-free survival (PFS), overall survival (OS), quality of life and cost-effectiveness. Kaplan-Meier curves will be used to analyse PFS and OS, while the Cox proportional hazards frailty model will be employed to compare outcomes between healthcare systems, adjusting for prognostic variables.

Ethics and dissemination
The study protocol was approved by the Ethics Committee of the HCor Research Institute (Hospital do Coracão/Associacão Beneficente Síria), which served as the central ethics board for the trial (study number: CAAE 42538621.5.1001.0060; approval letter number: 4.571.507; date: 3 March 2021). All participating centres also obtained approval from their respective local ethics committees prior to patient enrolment: Ethics Committee of Hospital de Câncer de Barretos—Fundacão Pio XII; Ethics Committee of Universidade Estadual de Campinas—UNICAMP; Ethics Committee of Faculdade de Minas Muriaé—FAMINAS; Ethics Committee of Hospital Santa Paula—SP; Ethics Committee of Hospital Alemão Oswaldo Cruz—SP; Ethics Committee of Hospital Regional do Câncer de Presidente Prudente—HRCPP; Ethics Committee of Instituto Brasileiro de Controle do Câncer—IBCC/Oncologia Clínica—SP; Ethics Committee of Instituto de Medicina Integral Prof. Fernando Figueira—IMIP/PE; Ethics Committee of Hospital São Rafael; Ethics Committee of Universidade Federal de São Paulo—UNIFESP; Ethics Committee of Hospital Geral de Fortaleza—HGF; Ethics Committee of Casa de Saúde Santa Marcelina; Ethics Committee of Centro Universitário FMABC; Ethics Committee of Liga Norte Riograndense Contra o Câncer; Ethics Committee of Hospital Mãe de Deus/Associacão Educadora São Carlos—AESC; and Ethics Committee of Instituto do Câncer Brasil—ICB. All patients will provide written informed consent. Study findings will be disseminated through scientific publications and presented to a broad range of stakeholders, including patients, physicians, the general public and policymakers.

Trial registration number
ClinicalTrials.gov identifier: NCT05559528—BRaziLian outcomE for metAStatic breasT cancer (BREAST).

Importance
Access to healthy and affordable foods may play a role in reducing inflammation and in healthy pulmonary immune system development.

Objective
To investigate the association between residing in a low-income and low-food-access (LILA) neighbourhood and risk of childhood asthma. A positive association was hypothesised.

Design, setting and participants
This prospective cohort study consists of 16 012 children from 35 longitudinal studies in the Environmental influences on Child Health Outcomes programme (children born 1998–2021) from across the contiguous USA. We conducted survival analyses adjusted for child sex, race/ethnicity, maternal education, gestational smoking, and parental history of asthma.

Exposure(s)
Several commonly used geospatial food access metrics were linked to residential locations including: LILA census tracts where the nearest supermarket is >1 mile in urban and >10 miles in rural areas (LILA1 and 10), >1 mile in urban and >20 miles in rural areas (LILA1 and 20), >0.5 mile in urban and >10 miles in rural areas (LILA0.5 and 10), and >0.5 mile without a vehicle or >20 miles (LILAvehicle). Each metric was linked to lifetime residential history timelines then dichotomised according to whether the child had spent at least 75% of their life living in a LILA area separately for birth through age 5 years (cumulative early childhood) and birth through age 11 years (cumulative middle childhood).

Main outcomes(s) and measure(s)
Asthma incidence in cumulative early and middle childhood.

Results
Residing in a LILA0.5 and 10 and LILAvehicleneighbourhood was associated with a higher asthma incidence in cumulative early and middle childhood. The LILA0.5 and 10 and LILAvehicle associations were stronger for asthma during cumulative early childhood, where we observed hazard ratios of 1.13 (95% CI 1.02 to 1.24) and 1.13 (95% CI 1.01 to 1.27), respectively. The associations were higher among children who were Hispanic, were female and had lower maternal education.

Conclusion and relevance
Limited residential food access was associated with higher childhood asthma incidence, especially among female and Hispanic children and those with lower maternal education. Our findings support multipronged efforts to increase access to healthy and affordable food options and lower food insecurity in LILA neighbourhoods.

Circulation, Ahead of Print. BACKGROUND:Equal access to care for patients with congenital heart disease (CHD) remains unrealized globally. The ASSIST project (Academic Medical Hospitals–Local Institutions collaboration) is an ongoing national quality initiative implemented in low-resource settings in China attempting to reduce gaps in access to CHD care. This study sought to evaluate its feasibility and effectiveness.METHODS:Shanghai Children’s Medical Center, an academic medical center, has partnered with 4 local hospitals in low-resource regions to enhance local CHD programs since 2021. Comparison was made between patients receiving treatments in these 4 local hospitals before (2013–2020) versus after the ASSIST project (2021–2024). In addition, contemporaneous patients receiving treatments in Shanghai Children’s Medical Center (2021–2024) were compared with the post-ASSIST cohort of patients. The primary outcome was a composite of postoperative mortality and multiorgan dysfunction. A key secondary outcome was delayed treatment, defined as an interval of more than 6 months between the time of surgery and the time when the clinicians recommended surgery at the initial presentation.RESULTS:The analysis cohort included 11 895 pediatric patients (median age, 2.0 years [25th–75th percentile 0.7–5.0]; 5933 female [49.9%]), with 3333 cases in the pre-ASSIST group, 1566 in the post-ASSIST group, and 6996 in the Shanghai Children’s Medical Center group. Lower family educational attainment (odds ratio, 1.50 [95% CI 1.21–1.85];P

Objective
To explore patient and healthcare professional perceptions about the acceptability and impact of a large-scale system for automated, real-time monitoring and feedback of shared decision-making (SDM) that has been integrated into surgical care pathways.

Design
Qualitative, semistructured interviews were conducted with patients and healthcare professionals between June and November 2021. Data were analysed using deductive and inductive approaches.

Setting
Large-scale monitoring of SDM has been integrated in NHS surgical care across two large UK National Health Service Trusts.

Participants
Adult surgical patients (N=18, 56% female), following use of an SDM real-time monitoring and feedback system, and healthcare professionals (N=14, 36% female) involved in their surgical care. Patient recruitment was conducted through hospital research nurses and professionals by direct approach from the study team to sample individuals purposively from seven surgical specialties (general, vascular, urology, orthopaedics, breast, gynaecology and urgent cardiac).

Results
10 themes were identified within three areas of exploration that described factors underpinning: (1) the acceptability of large-scale automated, real-time monitoring of SDM experiences, (2) the acceptability of real-time feedback and addressing SDM deficiencies and (3) the impact of real-time monitoring and feedback. There was general support for real-time monitoring and feedback because of its perceived ability to efficiently address deficiencies in surgical patients’ SDM experience at scale, and its perceived benefits to patients, surgeons and the wider organisation. Factors potentially influencing acceptability of large-scale automated, real-time monitoring and feedback were identified for both stakeholder groups, for example, influence of survey timing on patient-reported SDM scores, disease-specific risks, patients’ dissatisfaction with hospital processes. Factors particularly important for patients included concerns over digital exclusion exacerbated by electronic real-time monitoring. Factors unique to professionals included the need for detailed, qualitative feedback of SDM to contextualise patient-reported SDM scores.

Conclusions
This study explored factors influencing the acceptability of automated, real-time monitoring and feedback of patients’ experiences of SDM integrated into surgical practice, at scale among key stakeholders. Findings will be used to guide refinement and implementation of SDM monitoring and feedback prior to formal development, evaluation and implementation of an SDM intervention in the NHS.

Trial registration number
ISRCTN17951423.

The original protocol
doi: 10.1136/bmjopen-2023-079155.

Importance
Background rates are critical for contextualising safety signals arising from COVID-19-related interventions in investigational or real-world settings.

Objective
To estimate background rates of medical events of interest (MEI) for which COVID-19 infection and/or COVID-19 interventions may be risk factors in two US claims databases.

Design, setting and participants
This retrospective cohort study spans the pre-COVID-19 (2018–2019) and COVID-19 (2020–2021) periods. We constructed three cohorts, in each of Inovalon/HealthVerity (Inovalon/HV) and Optum databases: a COVID-19-positive adult cohort (2020–2021), a paediatric cohort (2018–2021) and a high-risk cohort (2018–2021) comprising patients at increased risk for severe COVID-19. Participants were indexed on the day they first qualified to enter each cohort during the study period. Background rates of 17 MEI were estimated per 1000 person-years (PY) with 95% CIs.

Main outcomes and measures
Annual incidence rates (IRs) of 17 MEI.

Results
Overall, 758 414 (COVID-19-positive adults; 57.8% women), 12 513 664 (high-risk adults; 56.8% women) and 8 510 627 (paediatric patients; 49.1% women) patients were identified in the HV database. IRs of MEI varied substantially by year, data source, study cohort and duration of follow-up. The IRs of MEI were highest among COVID-19-positive adults and lowest among paediatric patients. For example, IR of myocarditis/pericarditis per 1000 PY was 3.0 (95% CI: 2.6 to 3.4) in the COVID-19-positive adult cohort vs 0.36 (95% CI: 0.34 to 0.37) among high-risk adults and 0.05 (95% CI: 0.05 to 0.06) among paediatric patients. In the COVID-19-positive adult cohort, we observed higher IRs during 90-day follow-up (eg, IR of acute myocardial infarction (AMI) 26.5 (95% CI: 25.3 to 27.7)) vs 365-day follow-up (eg, IR of AMI 20.0 (95% CI: 9.2 to 20.8)) and during 2020 compared with 2021. IRs were higher in the high-risk adult and paediatric populations during the pre-COVID-19 period than during the COVID-19 pandemic.

Conclusions
Substantial variability was observed in IRs of MEI by study cohort, year, data source and follow-up duration. When generating background rates for contextualising safety signals from COVID-19 interventions, careful consideration must be given to the indicated subpopulation of interest, COVID-19-related temporal variations and data sources.