scholarly journals Use of real-world data to study health services utilisation and comorbidities in long-term breast cancer survivors (the SURBCAN study): study protocol for a longitudinal population-based cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e040253
Author(s):  
Anna Jansana ◽  
Isabel Del Cura ◽  
Alexandra Prados-Torres ◽  
Teresa Sanz Cuesta ◽  
Beatriz Poblador-Plou ◽  
...  

IntroductionBreast cancer has become a chronic disease due to survival improvement and the need to monitor the side effects of treatment and the disease itself. The aim of the SURBCAN study is to describe comorbidity, healthcare services use and adherence to preventive recommendations in long-term breast cancer survivors and to compare them with those in women without this diagnosis in order to improve and adapt the care response to this group of survivors.Methods and analysisPopulation-based retrospective cohort study using real-world data from cancer registries and linked electronic medical records in five Spanish regions. Long-term breast cancer survivors diagnosed between 2000 and 2006 will be identified and matched by age and administrative health area with women without this diagnosis. Sociodemographic and clinical variables including comorbidities and variables on the use of health services between 2012 and 2016 will be obtained from databases in primary and hospital care. Health services use will be assessed through the annual number of visits to primary care professionals and to specialists and through annual imaging and laboratory tests. Factors associated with healthcare utilisation and comorbidities will be analysed using multilevel logistic regression models. Recruitment started in December 2018.Ethics and disseminationThis study was approved by the Ethics Committee of Parc de Salut Mar. The results of the study will be published in a peer-reviewed journal and will be presented at national and international scientific conferences and at patient associations.Trial registration numberThis protocol is registered in Clinical Trials.gov (identifier: NCT03846999).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1048-1048
Author(s):  
Wei Fang Dai ◽  
Jaclyn Marie Beca ◽  
Chenthila Nagamuthu ◽  
Ning Liu ◽  
Maureen E. Trudeau ◽  
...  

1048 Background: Addition of P to T+chemo for MBC pts has been shown to improve overall survival (OS) in a pivotal randomized trial (hazard ratio [HR] = 0.66, 95% CI: 0.52, 0.84) (Baselga et al., NEJM 2012). In Canada, the manufacturer submission to the health technology assessment agency estimated that P produced 0.64 life years gained (LYG) with an incremental cost-effectiveness ratio (ICER) of $187,376/LYG over 10 years (CADTH-pCODR, 2013). This retrospective cohort analysis aims to determine the comparative real-world population-based effectiveness and cost-effectiveness of P among MBC pts in Ontario, Canada. Methods: MBC pts were identified from the Ontario Cancer Registry and linked to the New Drug Funding Program database to identify receipt of treatment between 1/1/2008 and 3/31/2018. Cases received P-T-chemo after universal public funding of P (Nov 2013) and controls received T-chemo before. Demographic (age, socioeconomic, rurality) and clinical (comorbidities, prior adjuvant treatments, prior breast cancer surgery, prior radiation, stage at diagnosis, ER/PR status) characteristics were identified from linked admin databases balanced between cases and controls using propensity score matching. Kaplan-Meier methods and Cox regressions accounting for matched pairs were used to estimate median OS and HR. 5-year mean total costs from the public health system perspective were estimated from admin claims databases using established direct statistical methods and adjusted for censoring of both cost and effectiveness using inverse probability weighting. ICERs and 95% bootstrapped CIs were calculated, along with incremental net benefit (INB) at various willingness-to-pay values using net benefit regression. Results: We identified 1,823 MBC pts with 912 cases and 911 controls (mean age = 55 years), of which 579 pairs were matched. Cases had improved OS (HR = 0.66; 95% CI: 0.57, 0.78), with median 3.4 years, compared to controls median OS of 2.1. P provided an additional 0.63 (95% CI: 0.48 – 0.84) LYG at an incremental cost of $196,622 (95% CI: $180,774, $219,172), with a mean ICER = $312,147/LYG (95% CI: $260,752, $375,492). At threshold of $100,000/LYG, the INB was -$133,632 (95% CI: -$151,525, -$115,739) with < 1% probability of being cost-effective. Key drivers of incremental cost increase between groups included drug and cancer clinic costs. Conclusions: The addition of P to T-chemo for MBC increased survival but at significant costs. The ICER based on direct real-world data was higher than the initial economic model due to higher total costs for pts receiving P. This study demonstrated feasibility to derive ICER from person-level real-world data to inform cancer drug life-cycle health technology reassessment.


Cancer ◽  
2020 ◽  
Author(s):  
Annika Möhl ◽  
Ester Orban ◽  
Audrey Y. Jung ◽  
Sabine Behrens ◽  
Nadia Obi ◽  
...  

2013 ◽  
Vol 52 (2) ◽  
pp. 423-429 ◽  
Author(s):  
Kathrine Carlsen ◽  
Anette Jung Jensen ◽  
Reiner Rugulies ◽  
Jane Christensen ◽  
Pernille Envold Bidstrup ◽  
...  

2014 ◽  
Vol 24 (1) ◽  
pp. 40-46 ◽  
Author(s):  
Martina E. Schmidt ◽  
Jenny Chang-Claude ◽  
Petra Seibold ◽  
Alina Vrieling ◽  
Judith Heinz ◽  
...  

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 1564-1564
Author(s):  
Helena Carreira ◽  
Rachael Williams ◽  
Garth Funston ◽  
Susannah Jane Stanway ◽  
Krishnan Bhaskaran

1564 Background: Breast cancer survivors are the largest group of cancer survivors in the United Kingdom (UK). Having had a breast cancer diagnosis may adversely affect the patient’s mental health. We aimed to estimate the long-term risk of anxiety and depression in women with history of breast cancer compared to those who have never had cancer. Methods: We conducted a matched population-based cohort study, using data from the Clinical Practice Research Datalink (CPRD) GOLD primary care database. The exposed cohort included all adult women diagnosed with breast cancer between 1987 and 2018; the unexposed group included women with no cancer history, matched to exposed women in a 4:1 ratio on primary care practice and age. Cox regression models stratified on matched set were used to estimate hazard ratios of the association between breast cancer survivorship and anxiety and depression. Results: 59,972 women (mean 62 years; standard deviation (SD) 14.0) had history of breast cancer. The median follow-up time was 3.0 years (SD 4.4), which amounted to 256,186 person-years under observation. The comparison group included 240,387 women followed up over 3.5 years (SD 4.5) (1,163,819 person-years). The incidence of anxiety in breast cancer survivors was 0.08 (95% confidence interval (95%) 0.07-0.08) per 1000 person-years, and the incidence of depression was 70 (95%CI 68-71) per 1000 person-years. The risks of both depression and anxiety were raised in breast cancer survivors compared with controls, and this appeared to be driven by the first 3 years following diagnosis (Table). Conclusions: Breast cancer survivors in the UK had significantly higher risk anxiety and depression diagnosed in primary care for three years following diagnosis than women who never had cancer. Risk of anxiety and depression in breast cancer survivors compared to women who did not have cancer by time since diagnosis. [Table: see text]


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