A stakeholder analysis to prepare for real-world evaluation of integrating artificial intelligent algorithms into breast screening (PREP-AIR study): a qualitative study using the WHO guide.

BACKGROUND: The national breast screening programme in the United Kingdom is under pressure due to workforce shortages and having been paused during the COVID-19 pandemic. Artificial intelligence has the potential to transform how healthcare is delivered by improving care processes and patient outcomes. Research on the clinical and organisational benefits of artificial intelligence is still at an early stage, and numerous concerns have been raised around its implications, including patient safety, acceptance, and accountability for decisions. Reforming the breast screening programme to include artificial intelligence is a complex endeavour because numerous stakeholders influence it. Therefore, a stakeholder analysis was conducted to identify relevant stakeholders, explore their views on the proposed reform (i.e., integrating artificial intelligence algorithms into the Scottish National Breast Screening Service for breast cancer detection) and develop strategies for managing 'important' stakeholders. METHODS: A qualitative study (i.e., focus groups and interviews, March-November 2021) was conducted using the stakeholder analysis guide provided by the World Health Organisation and involving three Scottish health boards: NHS Greater Glasgow & Clyde, NHS Grampian and NHS Lothian. The objectives included: (A) Identify possible stakeholders (B) Explore stakeholders' perspectives and describe their characteristics (C) Prioritise stakeholders in terms of importance and (D) Develop strategies to manage 'important' stakeholders. Seven stakeholder characteristics were assessed: their knowledge of the targeted reform, position, interest, alliances, resources, power and leadership. RESULTS: Thirty-two participants took part from 14 (out of 17 identified) sub-groups of stakeholders. While they were generally supportive of using artificial intelligence in breast screening programmes, some concerns were raised. Stakeholder knowledge, influence and interests in the reform varied. Key advantages mentioned include service efficiency, quicker results and reduced work pressure. Disadvantages included overdiagnosis or misdiagnosis of cancer, inequalities in detection and the self-learning capacity of the algorithms. Five strategies (with considerations suggested by stakeholders) were developed to maintain and improve the support of 'important' stakeholders. CONCLUSIONS: Health services worldwide face similar challenges of workforce issues to provide patient care. The findings of this study will help others to learn from Scottish experiences and provide guidance to conduct similar studies targeting healthcare reform. STUDY REGISTRATION: researchregistry6579, date of registration: 16/02/2021.

Understanding Stakeholder Views Regarding the Design of an Intervention Trial to Reduce Anticholinergic Burden: A Qualitative Study.

Background: Anticholinergic burden (ACB), is defined as the cumulative effect of anticholinergic medication which are widely prescribed to older adults despite increasing ACB being associated with adverse effects such as: falls, dementia and increased mortality. This research explores the views of health care professionals (HCPs) and patients on a planned trial to reduce ACB by stopping or switching anticholinergic medications. The objectives were to explore the views of key stakeholders (patients, the public, and HCPs) regarding the potential acceptability, design and conduct of an ACB reduction trial. Materials and Methods: We conducted qualitative interviews and focus groups with 25 HCPs involved in prescribing medication with anticholinergic properties and with 22 members of the public and patients who were prescribed with the medication. Topic guides for the interviews and focus groups explored aspects of feasibility including: 1) views of a trial of de-prescribing/medication switching; 2) how to best communicate information about such a trial; 3) views on who would be best placed and preferred to undertake such medication changes, e.g., pharmacists or General Practitioners (GPs)? 4) perceived barriers and facilitators to trial participation and the smooth conduct of such a trial; 5) HCP views on the future implementability of this approach to reducing ACB and 6) patients' willingness to be contacted for participation in a future trial. Qualitative data analysis was underpinned by Normalization Process Theory. Results: The public, patients and HCPs were supportive of an ACB reduction trial. There was consensus among the different groups that key points to consider with such a trial included: 1) ensuring patient engagement throughout to enable concerns/potential pitfalls to be addressed from the beginning; 2) ensuring clear communication to minimise potential misconceptions about the reasons for ACB reduction; and 3) provision of access to a point of contact for patients throughout the life of a trial to address concerns; The HCPs in particular suggested two more key points: 4) minimise the workload implications of any trial; and 5) pharmacists may be best placed to carry out ACB reviews, though overall responsibility for patient medication should remain with GPs. Conclusion: Patients, the public and HCPs are supportive of trials to reduce ACB. Good communication and patient engagement during design and delivery of a trial are essential as well as safety netting and minimising workload.

Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set.

BACKGROUND: Many completed trials of interventions for uncomplicated gallstone disease are not as helpful as they could be due to lack of standardisation across studies, outcome definition, collection and reporting. This heterogeneity of outcomes across studies hampers useful synthesis of primary studies and ultimately negatively impacts on decision making by all stakeholders. Core outcome sets offer a potential solution to this problem of heterogeneity and concerns over whether the 'right' outcomes are being measured. One of the first steps in core outcome set generation is to identify the range of outcomes reported (in the literature or by patients directly) that are considered important. OBJECTIVES: To develop a systematic map that examines the variation in outcome reporting of interventions for uncomplicated symptomatic gallstone disease, and to identify other outcomes of importance to patients with gallstones not previously measured or reported in interventional studies. RESULTS: The literature search identified 794 potentially relevant titles and abstracts of which 137 were deemed eligible for inclusion. A total of 129 randomised controlled trials, 4 gallstone disease specific patient-reported outcome measures (PROMs) and 8 qualitative studies were included. This was supplemented with data from 6 individual interviews, 1 focus group (n=5 participants) and analysis of 20 consultations. A total of 386 individual recorded outcomes were identified across the combined evidence: 330 outcomes (which were reported 1147 times) from trials evaluating interventions, 22 outcomes from PROMs, 17 outcomes from existing qualitative studies and 17 outcomes from primary qualitative research. Areas of overlap between the evidence sources existed but also the primary research contributed new, unreported in this context, outcomes. CONCLUSIONS: This study took a rigorous approach to catalogue and map the outcomes of importance in gallstone disease to enhance the development of the COS 'long' list. A COS for uncomplicated gallstone disease that considers the views of all relevant stakeholders is needed.

Protocol for a randomised controlled trial comparing laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones (C-Gall trial).

BACKGROUND: Gallstone disease (cholelithiasis) is common. In most people it is asymptomatic and does not require treatment, but in about 20% it can become symptomatic, causing pain and other complications requiring medical attention and/or surgery. A proportion of symptomatic people with uncomplicated gallstone disease do not experience further episodes of pain and, therefore, could be treated conservatively. Moreover, surgery carries risks of perioperative and postoperative complications. METHODS AND ANALYSIS: C-Gall is a pragmatic, multicentre, randomised controlled trial and economic evaluation to assess whether cholecystectomy is cost-effective compared with observation/ conservative management (here after referred to as medical management) at 18 months post-randomisation (with internal pilot). PRIMARY OUTCOME MEASURE: Patient-reported quality of life (QoL) (36-Item Short Form Survey (SF-36) bodily pain domain) up to 18 months after randomisation.The primary economic outcome is incremental cost per quality-adjusted life year gained at 18 months. SECONDARY OUTCOME MEASURES: Secondary outcome measures include condition-specific QoL, SF-36 domains, complications, further treatment, persistent symptoms, healthcare resource use, and costs assessed at 18 and 24 months after randomisation. The bodily pain domain of the SF-36 will also be assessed at 24 months after randomisation.A sample size of 430 participants was calculated. Computer-generated 1:1 randomisation was used.The C-Gall Study is currently in follow-up in 20 UK research centres. The first patient was randomised on 1 August 2016, with follow-up to be completed by 30 November 2021. STATISTICAL ANALYSIS: Statistical analysis of the primary outcome will be intention-to-treat and a per-protocol analysis. The primary outcome, area under the curve (AUC) for the SF-36 bodily pain up to 18 months, will be generated using the Trapezium rule and analysed using linear regression with adjustment for the minimisation variables (recruitment site, sex and age). For the secondary outcome, SF-36 bodily pain, AUC up to 24 months will be analysed in a similar way. Other secondary outcomes will be analysed using generalised linear models with adjustment for minimisation and baseline variables, as appropriate. Statistical significance will be at the two-sided 5% level with corresponding CIs. ETHICS AND DISSEMINATION: The North of Scotland Research Ethics Committee approved this study (16/NS/0053). The dissemination plans include Health Technology Assessment monograph, international scientific meetings and publications in high-impact, open-access journals. TRIAL REGISTRATION NUMBER: ISRCTN55215960; pre-results.

Interventions to Reduce Anticholinergic Burden in Adults Aged 65 and Older: A Systematic Review.

INTRODUCTION: Older age is associated with multimorbidity and polypharmacy with high anticholinergic burden (ACB). High ACB is linked to adverse events such as poor physical functioning, dementia, cardiovascular disease, and falls. Interventions are needed to reduce this burden. AIMS/OBJECTIVES: The aim was to systematically review the literature to identify and describe studies of clinical and cost-effectiveness of interventions designed to reduce ACB in adults (≥65 years) on polypharmacy regimes, compared with usual care. The objective was to answer the following questions: What are the contents of the interventions? Were these interventions clinically effective? Were these interventions cost effective?. DESIGN, SETTING, AND PARTICIPANTS: Systematic review of interventions to reduce anticholinergic burden in adults aged 65 and older in any clinical setting. METHODS: Eligible papers reported primary or secondary research describing any type of intervention including systematic reviews, randomized controlled trials (RCTs), controlled clinical trials, or nonrandomized pre-post intervention studies (PPIs) published in English from January 2010 to February 2019. Databases searched included CINAHL, Ovid MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (CENTRAL). RESULTS: The search yielded 5862 records. Eight studies (4 RCTs, 4 PPIs) conducted in hospital (4), community (2), nursing homes (1), and retirement villages (1) met the inclusion criteria. Pharmacists, either individually or as part of a team, provided the intervention in the majority of studies (6/8). Most (7/8) involved individual patient medication review followed by feedback to the prescriber. Two of the 4 RCTs and all non-RCTs reported a decrease in ACB following the intervention. No study reported cost outcome. CONCLUSIONS/IMPLICATIONS: Pharmacists may be well placed to implement an ACB reduction intervention. This is the first systematic review of interventions to reduce ACB in older adults, and it highlights the need for development and testing of high-quality pragmatic clinical and cost-effectiveness trials in community and specific patient populations at high risk of harm from ACB. [PROSPERO registration: CRD42018089764].

Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial.

BACKGROUND: Being overweight or obese following breast cancer diagnosis can increase cancer recurrence and mortality, so effective interventions for weight loss in this group could enhance survival. A pilot randomised controlled trial was conducted to assess whether a weight loss programme comprising generic Weight Watchers® referral offered to women treated for breast cancer with or without additional breast cancer-tailored dietetic support is feasible and shows promise for improving weight and quality of life (QoL). METHODS: Participants were randomly allocated to 3 groups: Weight Watchers® referral (for 12 sessions of meetings and digital tools) plus 5 breast cancer-tailored dietitian-led group support sessions (WW Plus: n = 14), Weight Watchers® referral only (WW: n = 16) or control (Weight Watchers® referral after 3 months, n = 15). Feasibility was assessed based on retention rate, recruitment and randomisation process, meeting attendance, suitability of the setting and outcome measurement tools, unintended consequences, cost and observations of the dietetic sessions. Outcomes were measured at 0, 3 ('trial exit') and 12 months post intervention. RESULTS: The response rate to the invitation was 43% (140/327) of whom 58 were eligible and 45 (median age 61.0 years; body mass index 30.2 kg/m2) were randomised. Data from 38 (84%) and 30 (67%) participants were available at trial exit and 12 months respectively. Feasibility issues included slow recruitment process, lack of blinding throughout, weighing scales not measuring > 150 kg, lack of clear instructions for completing QoL questionnaire and workload and time pressures in delivering dietetic sessions. Participants had good attendance rate at group meetings and no serious unintended consequences were reported. WW Plus was most expensive to run. Mean (95% CI) weight change at trial exit was - 3.67 kg (- 5.67, - 2.07) in WW Plus, - 6.03 kg (- 7.61, - 4.44) in WW group and + 0.19 kg (- 1.45, + 1.83) in control group. About 40% of the WW Plus, 64% of the WW group and 56% of the control group lost ≥ 5% of their baseline weight by 12 months. All groups showed promise for improving QoL at trial exit but only the WW group maintained significant improvements from baseline at 12 months. CONCLUSIONS: The trial procedures were feasible, with some modifications. This pilot trial indicates the benefits of providing free WW vouchers for weight loss maintenance and improving QoL but provided no evidence that including additional dietetic support would add any extra value. Further research with WW with long-term follow-up should be undertaken to assess weight loss sustainability and benefit on health outcomes in this patient group. TRIAL REGISTRATION: ISRCTN-29623418.