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

Objective
The aim of this study was to estimate the total national direct cost of breast cancer screening from 2019 to 2022 and project the total national cost and average lifetime cost of screening per woman for three current guidelines.

Design
We estimated the national cost of screening from 2019 to 2022, and per cancer detected in 2022, using real-world data on the number of mammograms performed per year. We also projected the national cost of screening using life table modelling for three guidelines: 2021/2023 American College of Radiology (ACR), 2023 American Cancer Society (ACS) and 2024 United States Preventative Services Task Force (USPSTF). The average lifetime cost to screen one woman until age 74 years with each guideline was also estimated. The Optum Labs Data Warehouse was used to estimate commercial and Medicare costs and recall rates. Sensitivity analyses were used to estimate uncertainty and determine which inputs had the largest impact on total national costs.

Setting
This study was conducted for the USA.

Participants
Women eligible for breast cancer screening.

Interventions
Digital mammograms (2D) or digital breast tomosynthesis (3D) and/or MRI.

Primary outcome measure
Total national cost of screening calculated as the sum of screening and recall costs. Average lifetime cost of screening per woman until 74 years.

Results
Nationally, screening cost approximately US$11 billion (B) per year from 2019 to 2022 with approximately 37% of eligible women screened each year. In 2022, screening cost US$55 471 per 3D-detected and US$44 000 per 2D-detected invasive or ductal carcinoma in situ case. Using target yearly participation rates of 54%–78% by age of women, the projected cost of screening was US$30B for ACR, US$18B for ACS and US$8B for USPSTF guidelines. The average lifetime cost to screen an average-risk woman was: US$13 416 for ACR, US$7946 for ACS and US$6931 for USPSTF. Participation rates, the proportion of women with a lifetime risk >20% and commercial MRI and 3D costs had the largest impact on total costs.

Conclusion
The cost of screening varies significantly by guideline (US$8B–US$30B) and was most influenced by participation rates, high-risk population proportions and technology costs. Future work can investigate whether risk-based screening strategies being tested in ongoing clinical trials can reduce national screening costs while improving outcomes.Cite Now

Background
Prostate cancer (PCa) is the most common male malignancy in the western world. Many men (40%) are diagnosed with localised low or intermediate-risk PCa, which is suitable for active surveillance (AS). AS affords careful monitoring to identify changes in otherwise non-life-threatening cancers. While AS reduces overtreatment (and quality of life impact), long-term compliance can be poor, with many men undergoing radical treatment after starting AS.

Methods and analysis
Finasteride in Active Surveillance for men with low and intermediate-risk prostate cancer (FINESSE) is a prospective, open-label, two-arm, phase 3 trial, in which men with low or intermediate PCa are randomised (1:1) to receive AS with or without finasteride (5 mg once a day for 2 years). Randomisation is stratified by age and PCa risk. AS includes regular prostate-specific antigen testing, MRI scans and the offer of repeat biopsy (at 3 years, or if imaging suggests progression). Additional MRI scans and/or biopsies will be performed for biochemical or clinical indications. We aim to recruit 550 men (aged 50 to 75 years) from up to eight sites. Active outpatient follow-up will be for 3–5 years (depending on date recruited), followed by passive registry-based follow-up for up to 10 years. Primary outcome is adherence to AS. Secondary outcomes include rates and type of disease progression, treatments received (for PCa and benign prostatic enlargement), overall and PCa-specific mortality, an understanding of patients/professionals views of this approach and health-related quality of life. An external panel of experts blinded to allocation will review all AS cessation and progression events. Trial pathologist’s and radiologist’s, blinded to allocation, will review representative cases. Analysis is Intention to Treat.

Ethics and dissemination
The study received Health Research Authority and South-Central Oxford Research Ethics Committee (14/12/2021: 21/SC/0349) and CTA/MHRA (29/12/2021: 21304/0274/001–0001) approvals. Results will be made available to providers and researchers via publicly accessible scientific journals.

Trial registration number
ISRCTN16867955

Objectives
Incontrovertible evidence surrounds the need to support healthcare professionals after patient safety incidents (PSIs). However, what characterises effective organisational support is less clearly understood and defined. This review aims to determine what support healthcare professionals want for coping with PSIs, what support interventions/approaches are currently available and which have evidence for effectiveness.

Design
Systematic research review with narrative synthesis.

Data sources
Medline, Scopus, PubMed and Web of Science databases (from 2010 to mid-2021; updated December 2022), reference lists of eligible articles and Connected Papers software.

Eligibility criteria for selecting studies
Empirical studies (1) containing information about support frontline healthcare staff want before/after a PSI, OR addressing (2) support currently available, OR (3) the effectiveness of support to help prevent/alleviate consequences of a PSI. Study quality was appraised using the Quality Assessment for Diverse Studies tool.

Results
Ninety-nine studies were identified. Staff most wanted: peer support (n=28), practical support and guidance (n=27) and professional mental health support (n=21). They mostly received: peer support (n=46), managerial support (n=23) and some form of debrief (n=15). Reports of poor PSI support were common. Eleven studies examined intervention effectiveness. Evidence was positive for the effectiveness of preventive/preparatory interventions (n=3), but mixed for peer support programmes designed to alleviate harmful consequences after PSIs (n=8). Study quality varied.

Conclusions
Beyond peer support, organisational support for PSIs appears to be misaligned with staff desires. Gaps exist in providing preparatory/preventive interventions and practical support and guidance. Reliable effectiveness data are lacking. Very few studies incorporated comparison groups or randomisation; most used self-report measures. Despite inconclusive evidence, formal peer support programmes dominate. This review illustrates a critical need to fund robust PSI-related intervention effectiveness studies to provide organisations with the evidence they need to make informed decisions when building PSI support programmes.

PROSPERO registration number
CRD42022325796.

Background
Frail older adults constitute a significant vulnerable group with complex healthcare needs requiring collaboration between various care providers and professions. Despite this requirement, there are considerable knowledge gaps in how to achieve effective collaboration. Preventive measures such as addressing pressure ulcers, falls, malnutrition and poor oral health often receive low priority compared with treating diseases or injuries. This study aims to enhance our understanding of how care collaboration in the preventive care process (PcP) using the Senior alert (SA) register could improve patient safety and equality of care for frail older adults in Sweden.

Methods
This study, conducted over 4 years, employs an explanatory mixed methods design, divided into three phases. The study protocol comprises the two first phases.

Phase 1 (quantitative)
Data from SA (2019–2021) will be analysed to compare municipalities regarding the quality of registration in the PcP. Municipalities with high and low compliance indices will be identified and analysed together with data on demographics, socioeconomics and organisation from Statistics Sweden.

Phase 2 (qualitative)
Focus group interviews will be conducted in residential care units in the municipalities identified in phase 1 with interprofessional teams and older persons/next of kin. Additionally, 30 semi-structured individual interviews with residential care managers and other relevant stakeholders will explore obstacles and opportunities for effective care collaboration.

Discussion
We foresee that the results will contribute to the development of a model for effective PcP and care collaboration that can be used to improve patient safety and quality of care for frail older adults. This model can be tested and upscaled to achieve a more effective and equitable healthcare system.

Ethics and dissemination
The study has been approved by the Swedish ethical review authority. Dissemination plans involve publications, data deposition and engagement with healthcare stakeholders to ensure the practical application of the findings.

Introduction
Despite the known health and educational benefits of physical activity and the risks of prolonged sedentary behaviour, only one in 10 adolescents globally meet physical activity guidelines, and three-quarters of the school day is spent sitting. TransformUs, an effective and cost-effective whole-of-school programme for promoting primary school children’s physical activity and reducing sedentary behaviour, has been adapted for secondary schools (TransformUs Secondary). The aim of this paper is to describe the protocol for TransformUs Secondary in relation to implementation and scale-up across Australia, and the real-world effectiveness of the intervention on adolescents’ physical activity and sedentary time, as well as sitting time, sleep, well-being and class and school engagement.

Methods and analysis
A type II hybrid implementation-effectiveness trial will be conducted using a mixed-methods design. For the implementation trial, TransformUs Secondary will be disseminated via key organisations nationally (eg, state departments of education) and available to all Australian secondary schools (n=1453). Implementation outcomes will be evaluated using the RE-AIM framework (reach, adoption, implementation and maintenance). Data will be collected at the school and teacher levels via the TransformUs website (website analytics), descriptive quantitative surveys, text messages to teachers and qualitative interviews with teachers, students and representatives from key organisations. Descriptive statistics will summarise quantitative data, with regression analyses examining the associations between implementation strategies and outcomes. Implementation levels will be classified as low, moderate or high based on the extent of intervention delivery. Qualitative data will be thematically analysed.
We will assess effectiveness outcomes in 10 Victorian secondary schools using a pragmatic 1:1 waitlist control design. The target sample is 600 Year 7–10 students (12–16 years). Primary outcomes include adolescents’ physical activity and sedentary time (assessed with accelerometry), and secondary outcomes include health (sleep and well-being), class and school engagement (on-task behaviour assessed via classroom observation and school attendance) and sitting time (assessed with posture monitors). Descriptive analyses will summarise students’ demographics, physical activity, sedentary behaviour and engagement, while mixed models will evaluate intervention effects on these outcomes, adjusted for confounders. Additionally, qualitative data will be thematically analysed using deductive and inductive coding in NVivo.

Ethics and dissemination
These trials were approved by the Deakin University Human Research Ethics Committee (2021–269) and by the following education authorities: Australian Capital Territory Education Directorate (RES 2317), New South Wales Department of Education (2022253), Northern Territory Department of Education (20865), Victoria Department of Education (2023_004712), Queensland Department of Education (550/27/2585), South Australian Department of Education (2022–0019), Tasmanian Department of Education (2022–25), Western Australian Department of Education (D23/1152724), and Melbourne Archdiocese Catholic Schools (1232). Results from this study will be disseminated through peer-reviewed journal articles, scientific conferences, summary reports to students and schools and stakeholder meetings.

Trial registration number
Australian Clinical Trials Registration Registry (ACTRN12622000600741).

Objectives
This study examines the relationship between adolescent mothers’ mental health problems (postnatal depression and generalised anxiety) and adherence to COVID-19 public health prevention strategies in rural Malawi. It is part of a larger previously published study investigating the impact of social and cultural factors on the mental health in adolescent mothers.

Design
A cross-sectional study was conducted from September 2021 to March 2022. The Edinburgh Postnatal Depression Scale (EPDS) and the Generalised Anxiety Disorder-7 (GAD-7) were used to identify the risk of postnatal depression (PND) and generalised anxiety disorder (GAD), respectively. Participants also responded to questions about their perception of COVID-19 and how they practiced the recommended COVID-19 prevention strategies.

Setting
The study was conducted at a rural hospital in Lilongwe, Malawi.

Participants
Adolescent postnatal mothers aged 19 years and below, with children aged less than 1 year, who understood the study and could consent.

Results
Adolescent mothers (n=395) completed the researcher-administered survey. The mean age was±17 (SD 1.157). Most participants had recently given birth to their first child (91%, n=358). Almost half (45%, n=113) of participants agreed with the COVID-19 prevention strategies recommended by the Malawian government. However, overall adherence to public health COVID-19 prevention strategies, including hand hygiene practices, was low among adolescent mothers. Participants with probable GAD and probable PND were more likely to practice COVID-19 prevention strategies than participants with low GAD-7 or EPDS scores, except for restrictions on religious gatherings.

Conclusions
Adolescent perception of the potential threats or risks of COVID-19 was low. However, adolescents with probable PND and probable GAD reported higher adherence to some COVID-19 prevention strategies than adolescents without PND and GAD. The findings support the need for policies that integrate mental health within the public health response due to the potential direct and indirect effects the pandemic might have on perinatal mothers’ mental health. Additionally, recommended pandemic responses should be appropriate and relevant to the social environment.

Objectives
Alzheimer’s disease (AD) poses a significant challenge for individuals aged 65 and older, being the most prevalent form of dementia. Although existing AD risk prediction tools demonstrate high accuracy, their complexity and limited accessibility restrict practical application. This study aimed to develop a convenience, efficient prediction model for AD risk using machine learning techniques.

Design and setting
We conducted a cross-sectional study with participants aged 60 and older from the National Alzheimer’s Coordinating Center. We selected personal characteristics, clinical data and psychosocial factors as baseline predictors for AD (March 2015 to December 2021). The study utilised Random Forest and Extreme Gradient Boosting (XGBoost) algorithms alongside traditional logistic regression for modelling. An oversampling method was applied to balance the data set.

Interventions
This study has no interventions.

Participants
The study included 2379 participants, of whom 507 were diagnosed with AD.

Primary and secondary outcome measures
Including accuracy, precision, recall, F1 score, etc.

Results
11 variables were critical in the training phase, including educational level, depression, insomnia, age, Body Mass Index (BMI), medication count, gender, stenting, systolic blood pressure (sbp), neurosis and rapid eye movement. The XGBoost model exhibited superior performance compared with other models, achieving area under the curve of 0.915, sensitivity of 76.2% and specificity of 92.9%. The most influential predictors were educational level, total medication count, age, sbp and BMI.

Conclusions
The proposed classifier can help guide preclinical screening of AD in the elderly population.

Objectives
This study aims to assess self-reported health complaints and healthcare-seeking behaviours in a rural population of Bangladesh. These factors are crucial for understanding health challenges and designing effective healthcare services in rural areas.

Design
A cross-sectional survey was conducted from May to October 2021.

Setting
Four randomly selected administrative districts/regions of Bangladesh.

Participants
A total of 1645 rural participants aged 18 years and older.

Outcome measures
The study assessed the prevalence of self-reported health complaints and healthcare-seeking behaviours.

Results
Among the participants, 66% (1084 out of 1645) reported experiencing health complaints, with 80% seeking care and 20% either not seeking care or opting for self-care. Multivariable analysis revealed that participants with formal occupations (adjusted OR (aOR) = 0.609; 95% CI 0.396 to 0.938; p=0.025), those from the second (aOR=1.742; 95% CI 1.014 to 2.991; p=0.044) and fifth quintiles (aOR=1.210; 95% CI 0.726 to 2.019; p=0.465), with non-communicable disease (NCD) related complaints (aOR=5.299; 95% CI 3.673 to 7.643; p

Objectives
To evaluate the trend of prescription of the four foundational therapies, and their impact on 30-day urgent re-admissions and all-cause death in patients with heart failure and reduced ejection fraction (HFrEF) following an acute decompensation event.

Design
Retrospective.

Setting
One tertiary referral centre.

Participants
999 consecutively patients admitted with a primary diagnosis of HFrEF between January 2020 and June 2023 were identified through a validated, high-performance technology infrastructure based on artificial intelligence. The entire cohort was divided into three time periods based on two time points: September 2021 (ie, the release of the latest European guidelines) and January 2022 (ie, reimbursement for sodium-glucose cotransporter 2 (SGLT2) inhibitors).

Primary and secondary outcome measures
Trends and predictors of the prescription of each of the four foundational therapies and of the composite of all-cause death and rehospitalisation for urgent causes at 30 days.

Results
Among the 999 included patients, β-blockers were prescribed in 93% of patients, ACE inhibitor (ACEi)/angiotensin receptor blocker (ARB)/angiotensin–neprilysin receptor inhibitor (ARNi) in 73%, mineralocorticoid receptor antagonist in 30% and SGLT2 inhibitors in 18%. Over time, an increase in the prescription rate occurred only for SGLT2 inhibitors (3% vs 10% vs 32%, p

Objectives
Currently, there is no generally accepted consensus on how to translate strength of evidence into language. Against this background, we here investigated how widely used verbal descriptors of evidence grades and clinical practice recommendations, respectively, are understood, interpreted and transferred into intentions to treat. We explored differences between medical specialists and undergraduate medical students.

Design
Cross-sectional, anonymous online survey. Assessment was based on publicly available proposals for wording to characterise strength of evidence from randomised versus non-randomised trials and of clinical practice recommendations, respectively.

Setting
The online survey was conducted between September 2021 and March 2022 and promoted by several professional organisations in German-speaking European countries (Germany, Austria and Switzerland).

Participants
Medical students, trainees and medical specialist (open to all medical specialties).

Outcome
The survey was composed of two sections: (1) Aim of the first survey section was to assess if the linguistic differentiation between results from randomised versus non-randomised studies is correctly understood as put forward by the proponents. To this end, participants were asked to grade the relative weight of the expression for the results of a randomised trial versus two proposals for how to express the results of non-randomised studies. (2) Next, strong positive, weak positive, weak negative and strong negative clinical recommendations were presented, and participants were asked to answer in a forced-choice format if they would treat all/no patients, selected patients or only consider treatment. Additionally, the number of eligible patients who would be treated was assessed.

Results
N=1081 physicians and N=539 medical students completed the survey. (1) Less than half of the participants (48.5%) interpreted use of ‘associated with’ as linguistic differentiation between results from randomised versus non-randomised trials in a sense as put forward by the proponents. However, use of the subjunctive mood (‘could’) resulted in 87.3% correct differentiations. (2) Even with only four types of clinical practice recommendations (positive/negative and strong/weak), interpretation and translation into intention to treat, respectively, showed a heterogeneous picture: while the presentation of a strong clinical recommendation led to largely congruent responses, the interpretation of weak recommendations showed a high variability, with no clear response pattern for intentions to treat. Responses from physicians and medical students were largely comparable.

Conclusion
This study demonstrates limitations in the currently used linguistic expressions of strength of evidence and clinical practice recommendations and supports the need to prospectively test effects of language on intentions to treat prior to implementation of a certain wording. Study results cast doubt on that linguistic means alone will lead to optimally targeted intentions to treat.

Objectives
The type of electronic nicotine delivery system (ENDS) used by different age groups may be associated with ENDS and cigarette use behaviours. This study sought to identify differences in the use of ENDS device type based on age and cigarette use status to inform policy about regulating ENDS.

Design
This was a cross-sectional study.

Setting
Data was derived from a national survey conducted in 2021 in the USA.

Participants
Participants include 2369 US youth and adults (13 years or older) who reported past 30-day ENDS use.

Outcome measures
Past 30-day fairly regular use (i.e., several times a week or more) of ENDS device types, namely cigalikes, disposables, refillable tank/box mods, closed pods, refillable pods and drippers. Cigarette smoking status was also measured.

Results
We used weighted regression models to determine the association between ENDS device type current regular use and age group and the association between each ENDS type current regular use and smoking status separately for each age group. Youth ENDS users 13–17 years old were more likely to regularly use cigalikes (OR=2.71), disposables (OR=3.44), closed pods (OR=2.57) and drippers (OR=2.86) and 18–29 years old were more likely to regularly use disposables (OR=3.67), closed pods (OR=1.58) and drippers (OR=1.94), compared with 30+ years old ENDS users (all p

Objectives
To estimate the levels and trends of maternal and child healthcare (MCH) service utilisation in India across subsidised and unsubsidised health sectors and to explore total market approach to identify geographies where the private sector has potential to improve MCH services in India.

Design and setting
This study used three recent rounds of the National Family Health Survey (NFHS), a cross-sectional survey in India, conducted in 2005–2006, 2015–2016 and 2019–2021. Bivariate analysis and multinomial logistic regression were used to estimate the utilisation of key MCH indicators from subsidised and unsubsidised health sectors. Market sustainability of key MCH indicators was assessed by level of MCH services and subsidisation.

Participants
36 850, 190 898 and 176 843 ever-married women aged 15–49 years, 4440, 22 500 and 15 334 children under 5 years of age with diarrhoea before the survey, and 2552, 6960 and 6117 children with symptoms of acute respiratory infections (ARI) in NFHS 2005–2006, 2015–2016 and 2019–2021, respectively.

Outcome measures
The study used three maternal healthcare indicators: women had four or more antenatal care (ANC) visits, had institutional delivery, and received postnatal care (PNC); and two child healthcare indicators: care seeking for ARI and diarrhoea.

Results
In India, utilisation of maternal healthcare services increased over the last 15 years: four or more ANC visits increased from 37% to 58% and PNC of mothers increased from 33% to 78% between 2005–2006 and 2019–2021. The results of the multivariate analysis showed that utilisation of ANC (67% from public vs 18% from private health facilities), institutional delivery (64% from public vs 25% from private health facilities) and PNC (73% from public vs 27% from private health facilities) was significantly higher (p

Objectives
This study aims to systematically assess the global, regional, and national burden of asthma attributable to nitrogen dioxide (NO2) pollution.

Design and setting
Analysis of population-level data from 1990 to 2021 obtained from the Global Burden of Disease Study 2021, covering 204 countries and territories.

Participants
Participants included patients with asthma attributable to NO2 pollution.

Main outcomes and measures
Asthma-related disability-adjusted life-years (DALYs) and age-standardised DALY rates (ASDR) attributable to NO2 pollution across 204 countries and territories. The estimated annual percentage change (EAPC) was used to assess temporal trends to identify regions with increasing or decreasing asthma burdens.

Results
In 2021, NO2 pollution contributed to approximately 176.73 thousand DALYs globally, with an ASDR of 2.48 per 100 000 population (95% uncertainty interval (UI) –2.26 to 10.30). The global ASDR declined significantly from 1990 to 2021, with an EAPC of –1.93% (95% CI –2.14% to –1.72%). High-income North America had the highest ASDR (10.74 per 100 000; 95% UI 10.12 to 46.56), while Australasia experienced the most significant reduction in ASDR over the study period (EAPC –3.92%; 95% CI –4.46% to –3.37%). In contrast, Oceania and Southeast Asia showed increasing trends in asthma burden, with EAPCs of 2.33% (95% CI 1.57% to 3.10%) and 1.14% (95% CI 0.81% to 1.47%), respectively. The 5–9 age group carried the highest asthma burden, reflecting the vulnerability of younger children to NO2 exposure. A positive correlation between ASDR and sociodemographic index (SDI) was observed (R=0.637, p

Objective
The attrition of medical students is an incredibly important problem feeding into healthcare workforce issues. This study seeks to explore the relationships between various mental health issues and dropout.

Design
This is a longitudinal study where medical students completed an online questionnaire between November 2020 and February 2021 and those who took part were invited (February–May 2021) to complete the questionnaire again 3 months later.

Settings
Students from nine geographically spread medical schools in the UK took part in this study.

Participants
792 (71.16%) participants filled in the baseline questionnaire and 407 (51.39%) of these students completed the follow-up survey (385 participants were lost to follow-up).

Outcome measures
Dropout intentions.

Exposures
Various mental ill-health symptoms using validated scales: emotional exhaustion, insomnia, somatisation, hazardous drinking, anxiety/depression, anorexia tendencies, obsessive-compulsive disorder (OCD), paranoia and bipolar.

Results
A large number of students met the criteria for mental health disorders (eg, 54.1% insomnia, 37.9% anxiety/depression, 19.4% paranoia) and 19.4% (79) said that they considered dropping out from medical school. Those students who were more emotionally exhausted (Badjusted=0.94, p

Introduction
The prognosis for epithelial ovarian cancer (EOC) is exceedingly poor, with patients diagnosed with stage III/IV tumours typically offered cytoreductive surgery in conjunction with chemotherapy as a standard treatment option. This approach is intended to reduce the risk of surgery and address ovarian cancers that are not amenable to surgical intervention. A promising alternative and important treatment option is neoadjuvant chemotherapy (NACT) in conjunction with interstitial tumour cytoreductive surgery. The combination of neoadjuvant immunotherapy with chemotherapy has recently demonstrated remarkable efficacy, particularly in melanoma and lung cancer, with notable pathological responses and therapeutic benefits in tumour tissue. The NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr(NAIVE) study aims to assess the clinical efficacy and safety of NACT in combination with tislelizumab (a monoclonal antibody for programmed cell death protein 1) for advanced EOC.

Methods and analysis
The NAIVE study is an investigator-initiated, prospective, single-centre, open-label, randomised controlled trial for advanced EOC with the International Federation of Gynaecology and Obstetrics (FIGO) stage IIIc with a Suidan CT score of 3 or greater or a Fagotti laparoscopic score of 8 or greater; or FIGO stage IV. The primary endpoint of the study is the 1-year progression-free survival (PFS) rate, measured as the percentage of patients who are free of tumour progression or death for 1 year after receiving the first dose of study drug. The secondary endpoints encompassed the R0 resection rate, the clinical response rate and other relevant metrics. Enrolled patients will be randomly assigned in a 1:1 ratio to either the experimental arm, which will receive neoadjuvant platinum-based chemotherapy in combination with tislelizumab, or the control arm, which will receive neoadjuvant platinum-based chemotherapy. The study will enrol 40 patients, with enrolment scheduled to start in April 2021 and complete in April 2025, given a 1-year PFS rate of 60%. The study will provide new evidence regarding the clinical efficacy and safety of NACT in combination with tislelizumab for advanced ovarian cancer. The results will contribute to a deeper understanding of the clinical effects, safety profile and fundamental immunological processes. The findings will contribute to the growing body of evidence in support of the incorporation of immunotherapy into the treatment paradigm for ovarian cancer, thus facilitating the development of more personalised and efficacious therapeutic modalities.

Ethics and dissemination
This trial has received ethical approval from the Institutional Ethics Committee of the Second Affiliated Hospital of the Medical College of Zhejiang University. Presentations at scientific and professional meetings and publication in peer-reviewed journals will disseminate the results of the study.

Trial registration number
NCT04815408.