Dataset Information

What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420).

ABSTRACT: BACKGROUND:In principle, risk-stratification as a routine part of the NHS Breast Screening Programme (NHSBSP) should produce a better balance of benefits and harms. The main benefit is the offer of NICE-approved more frequent screening and/ or chemoprevention for women who are at increased risk, but are unaware of this. We have developed BC-Predict, to be offered to women when invited to NHSBSP which collects information on risk factors (self-reported information on family history and hormone-related factors via questionnaire; mammographic density; and in a sub-sample, Single Nucleotide Polymorphisms). BC-Predict produces risk feedback letters, inviting women at high risk (?8% 10-year) or moderate risk (?5 to

SUBMITTER: French DP

PROVIDER: S-EPMC7302349 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420).

French David P DP Astley Susan S Brentnall Adam R AR Cuzick Jack J Dobrashian Richard R Duffy Stephen W SW Gorman Louise S LS Harkness Elaine F EF Harrison Fiona F Harvie Michelle M Howell Anthony A Jerrison Andrew A Machin Matthew M Maxwell Anthony J AJ McWilliams Lorna L Payne Katherine K Qureshi Nadeem N Ruane Helen H Sampson Sarah S Stavrinos Paula P Thorpe Emma E Ulph Fiona F van Staa Tjeerd T Woof Victoria V Evans D Gareth DG

BMC cancer 20200618 1

<h4>Background</h4>In principle, risk-stratification as a routine part of the NHS Breast Screening Programme (NHSBSP) should produce a better balance of benefits and harms. The main benefit is the offer of NICE-approved more frequent screening and/ or chemoprevention for women who are at increased risk, but are unaware of this. We have developed BC-Predict, to be offered to women when invited to NHSBSP which collects information on risk factors (self-reported information on family history and ho ...[more]

PMID: 32552763

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Project description:ObjectivesProposals to stratify breast screening by breast cancer risk aim to produce a better balance of benefits to harms. Notably, risk estimation calculated from common risk factors and a polygenic risk score would enable high-risk women to benefit from more frequent screening or preventive medication. This service would also identify low-risk women who experience fewer benefits from attending, as lower grade and in situ cancers may be treated unnecessarily. It may therefore be appropriate for low-risk women to attend screening less. This study aimed to elicit views regarding implementing less frequent screening for low-risk women from healthcare professionals who implement risk-stratified screening.MethodsHealthcare professionals involved in the delivery of risk-stratified breast screening were invited to participate in a focus group within the screening setting in which they work or have a telephone interview. Primary care staff were also invited to provide their perspective. Three focus groups and two telephone interviews were conducted with 28 healthcare professionals. To identify patterns across the sample, data were analysed as a single dataset using reflexive thematic analysis.ResultsAnalysis yielded three themes: Reservations concerning the introduction of less frequent screening, highlighting healthcare professionals' unease and concerns towards implementing less frequent screening; Considerations for the management of public knowledge, providing views on media impact on public opinion and the potential for a low-risk pathway to cause confusion and raise suspicion regarding implementation motives; and Deliberating service implications and reconfiguration management, where the practicalities of implementation are discussed.ConclusionsHealthcare professionals broadly supported less frequent screening but had concerns about implementation. It will be essential to address concerns regarding risk estimate accuracy, healthcare professional confidence, service infrastructure and public communication prior to introducing less frequent screening for low-risk women.

Project description:ObjectiveTo assess the overall cost effectiveness of the NHS breast screening programme, based on findings of the Independent UK Panel on Breast Cancer Screening and taking into account the uncertainty of associated estimates of benefits, harms, and costs.DesignA life table model comparing data from two cohorts.SettingUnited Kingdom's health service.Participants and interventions364,500 women aged 50 years-the population of 50 year old women in England and Wales who would be eligible for screening-were followed up for 35 years without screening, compared with a similar cohort who had regular mammographic screening between ages 50 and 70 years and were then followed for another 15 years.Main outcome measuresBetween the cohorts, we compared the number of breast cancer diagnoses, number of deaths from breast cancer, number of deaths from other causes, person years of survival adjusted for health quality, and person years of survival with breast cancer. We also calculated the costs of treating primary and end stage breast cancer, and the costs of screening. Probabilistic sensitivity analysis explored the effect of uncertainty in key input parameters on the model outputs.ResultsUnder the base case scenario (using input parameters derived from the Independent Panel Review), there were 1521 fewer deaths from breast cancer and 2722 overdiagnosed breast cancers. Discounting future costs and benefits at a rate of 3.5% resulted in an additional 6907 person years of survival in the screened cohort, at a cost of 40,946 additional years of survival after a diagnosis of breast cancer. Screening was associated with 2040 additional quality adjusted life years (QALYs) at an additional cost of £42.5m (€49.8m; $64.7m) in total or £20,800 per QALY gained. The gain in person time survival over 35 years was 9.2 days per person and 2.7 quality adjusted days per person screened. Probabilistic sensitivity analysis showed that this incremental cost effectiveness ratio varied widely across a range of plausible scenarios. Screening was cost effective at a threshold of £20,000 per QALY gained in 2260 (45%) scenarios, but in 588 (12%) scenarios, screening was associated with a reduction in QALYs.ConclusionThe NHS breast screening programme is only moderately likely to be cost effective at a standard threshold. However, there is substantial uncertainty in the model parameter estimates, and further primary research will be needed for cost effectiveness studies to provide definitive data to inform policy.

Project description:Context and objectiveStandards for clinical practice guidelines require explicit statements regarding how values and preferences influence recommendations. However, no cancer screening guideline has addressed the key question of what magnitude of benefit people require to undergo screening, given its harms and burdens. This article describes the development of a new method for guideline developers to address this key question in the absence of high-quality evidence from published literature.Summary of methodThe new method was developed and applied in the context of a recent BMJ Rapid Recommendation clinical practice guideline for colorectal cancer (CRC) screening. First, we presented the guideline panel with harms and burdens (derived from a systematic review) associated with the CRC screening tests under consideration. Second, each panel member completed surveys documenting their views of expected benefits on CRC incidence and mortality that people would require to accept the harms and burdens of screening. Third, the panel discussed results of the surveys and agreed on thresholds for benefits at which the majority of people would choose screening. During these three steps, the panel had no access to the actual benefits of the screening tests. In step four, the panel was presented with screening test benefits derived from a systematic review of clinical trials and microsimulation modelling. The thresholds derived through steps one to three were applied to these benefits, and directly informed the panel's recommendations.ConclusionWe present the development and application of a new, four-step method enabling incorporation of explicit and transparent judgements of values and preferences in a screening guideline. Guideline panels should establish their view regarding the magnitude of required benefit, given burdens and harms, before they review screening benefits and make their recommendations accordingly. Making informed screening decisions requires transparency in values and preferences judgements that our new method greatly facilitates.

Dataset Information

What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420).

Publications

What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420).

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