Elena Pizzo

Lung cancer is a leading cause of ill health and death with early diagnosis key to improving outcomes. The LungIMPACT randomised study found that the use of an artificial intelligence (AI) tool to flag and prioritise chest X-rays (CXR) referred from primary care in the human reporter’s worklist, did not reduce time from CXR to lung cancer (LC) diagnosis. This health economic analysis estimated relative cost-effectiveness of using AI for CXR prioritisation, compared firstly to AI support in interpretation only and, secondly, to current practice using no AI support. The primary analysis estimated incremental cost per day reduction in time from CXR to lung cancer (LC) diagnosis or date of discharge from lung cancer pathway, of AI with vs without prioritisation. Secondary analyses addressed (i) AI with prioritisation vs AI without; (ii) AI with prioritisation vs No AI; and (iii) AI with or without prioritisation vs No AI. AI with prioritisation was not cost-effective vs. AI without prioritisation and secondary analysis showed that no AI was always more cost-effective. Budget impact was £2 million per year in England for AI with prioritisation vs AI without, rising to £16–35 million per year for comparisons to No AI. The results of this analysis show that AI prioritisation of GP-referred CXRs costs the NHS money and evidence must be generated for meaningful impact on the clinical pathway if AI is to be deployed in this setting.

Child maltreatment is a major public health problem with significant consequences for individual victims and for society. In this paper, we quantify for the first time the economic costs of fatal and...

Objectives The Circle of Security-Parenting (COS-P) group intervention has demonstrated efficacy in reducing maternal perinatal mental health difficulty (PMHD) symptoms in some contexts. The Circle of Security Intervention (COSI) study, a multisite, individually randomised, single-blind, parallel-arm controlled trial, was conducted in England to assess the clinical effectiveness of COS-P in reducing perinatal psychopathology, parenting and infant development, as well as its acceptability among the National Health Service (NHS) participants and staff. The main aim of this work is to estimate the cost-utility of COS-P plus treatment as usual (TAU) relative to TAU among mothers and birthing parents receiving NHS perinatal mental health services (PMHS) in England. Design A within-trial economic evaluation was performed comparing COS-P plus TAU with TAU alone, using data from the COSI trial, which employed a 2:1 randomisation ratio. Analyses were conducted from both NHS and personal social services (PSS) and societal perspectives. A 12-month time horizon was used, consistent with the final trial follow-up. Setting Secondary care NHS perinatal health services across multiple centres in England. Participants A total of 371 mothers and birthing parents with PMHD were randomised and had complete economic outcome data; 248 received COS-P plus TAU and 123 received TAU alone. Participants were eligible if they were receiving NHS PMHS; exclusion criteria were defined in the trial protocol. Interventions Participants in the intervention arm received the COS-P group programme in addition to TAU. The control group received TAU alone. Primary and secondary outcome measures The primary economic outcome was quality-adjusted life years (QALYs) over 12 months, derived from the 5-level EuroQol five-dimensional (EQ-5D-5L) questionnaire - responses. Costs were estimated from NHS and PSS as well as societal perspectives, including healthcare utilisation and productivity losses due to work absence. Results Compared with TAU, COS-P was associated with higher costs from both NHS and PSS (£180.58; 95% CI −£1075 to £1436) and societal (£72.94; 95% CI −£1473 to £1619) perspectives. COS-P was marginally less effective in terms of QALYs (−0.01; 95% CI −0.06 to 0.05). Probabilistic sensitivity analyses indicated substantial uncertainty around cost and effectiveness estimates. Conclusions On average, COS-P was associated with higher costs and did not demonstrate improvements in health-related quality of life compared with TAU alone. Given the uncertainty surrounding the estimates, further research is warranted to explore potential longer term economic and clinical impacts of COS-P in perinatal mental health settings. Trial registration number SRCTN18308962.

Objectives To assess the feasibility of delivering the swallowing prehabilitation intervention known as Swallowing Intervention Package: Self-Monitoring, Assessment and Rehabilitation Training (SIP SMART) within the National Health Service (NHS) head and neck cancer care pathway. Design Two-arm cluster-randomised pilot trial: SIP SMART2 trial. Setting and participants Adults newly diagnosed with stage II–IV head and neck cancer receiving curative treatment within a multidisciplinary team who agree to participate. Interventions Six hospitals were randomised. Trained clinicians at the intervention sites delivered the manualised SIP SMART intervention, while standard care was provided at care as usual (CAU) sites. The intervention included two 45-minute consultations incorporating an X-ray swallow assessment, tailored exercises/advice and specific behaviour change strategies while CAU involved a single consultation of information giving and provision of a generic exercise sheet. Outcomes Study outcomes related to feasibility of the cluster-randomised design, recruitment of both sites and patients and completeness of clinical and health economic data collected at baseline, 4 weeks, 12 weeks and 24 weeks after treatment. Results 12 hospitals expressed interest and six were randomised (50%) and provided data to the point of study completion. Patient recruitment across all sites (n=76) reached the target, although two sites fell short of their individual targets. The proportion of people with HNC recruited versus those eligible for each arm was 39% (95% CI 29 to 49) for SIP SMART group and 55% (95% CI 43 to 66) for CAU. The end point data at 24 weeks were completed for 50% (95% CI 33 to 67) for SIP SMART and 78% (95% CI 62 to 89) for CAU. Adherence to the intervention was above 50% at all time points. No harms related to the intervention were reported. Conclusions It is feasible to deliver the SIP SMART intervention embedded within the NHS cancer care pathway using a cluster-randomised design. A future trial will be optimised for efficiency in set-up and follow-up data collection based on these findings and learnings from the accompanying process evaluation study. Trial registration number ISRCTN12377415.

Introduction Radiological imaging is a central facet of the multidisciplinary evaluation of suspected child physical abuse. Current guidelines for the imaging of suspected child physical abuse are often unclear, incomplete and highly variable regarding recommendations on critical questions, thereby risking clinical heterogeneity, unstructured decision-making and missed diagnoses. We, therefore, aim to develop and report an evidence-based and consensus-derived international guideline for the radiological investigation of index and contact children in the context of suspected physical abuse and to ascertain areas of scientific uncertainty to inform future research priorities. Methods and analysis The international guidelines for the imaging investigation of suspected child physical abuse (IGISPA) consensus group includes formal representation from 127 recognised experts across 14 subspecialties, six continents and 32 national and/or international organisations. Participants will be divided into five longitudinal subgroups (indications for imaging, skeletal imaging, visceral imaging, neuroimaging and postmortem imaging) with three cross-cutting themes (radiography, genetics and adaptations for low- and lower-middle-income countries). Each subgroup will develop preliminary consensus statements via integration of current evidence-based guidelines, systematic literature review and the clinical expertise of a multinational group of experts. Statements will then undergo anonymised voting in a modified e-Delphi process and iterative revision until consensus (≥80% agreement) is achieved. Final statements will undergo both internal and external peer review prior to endorsement. Ethics and dissemination As an anonymous survey of consenting healthcare professionals, this study did not require ethical approval. Experts provided written informed consent to participate prior to commencement of the modified Delphi process. The IGISPA consensus statement and any subsequent guidance will be published open access in peer-reviewed medical journals.

Background: Digital interventions can be effective for reducing alcohol consumption. However, most digital interventions that have been evaluated are websites and there is little evidence on the effectiveness of smartphone apps, especially in a United Kingdom context. We developed an evidence- and theory-informed app, Drink Less, to help increasing-and-higher-risk drinkers (Alcohol Use Disorders Identification Test score ≥ 8) reduce their alcohol consumption. Objective: To evaluate the effectiveness of Drink Less for reducing alcohol consumption compared with usual digital care in the United Kingdom. Design: Two-arm, double-blind, parallel-group, randomised controlled trial with 1 : 1 group allocation and an embedded process evaluation, with 6-month follow-up. Setting: Remotely conducted among participants living in the United Kingdom, recruited from July 2020 to March 2022. Participants: Five thousand six hundred and two increasing-and-higher-risk drinkers aged 18+ who had access to an iPhone operating system device and wanted to drink less alcohol. Interventions: Participants were recommended to use the intervention (Drink Less) or recommended the comparator (National Health Service alcohol advice web page). Drink Less is an app-based intervention to help increasing-and-higher-risk drinkers reduce their alcohol consumption. It consists of evidence-based modules (e.g. goal setting, self-monitoring) and was systematically and transparently developed and refined. The National Health Service alcohol advice web page was considered usual digital care and provides tips on cutting down. Main outcome measures: The primary outcome was self-reported weekly alcohol consumption at 6-month follow-up (derived from the extended Alcohol Use Disorders Identification Test – Consumption), adjusted for baseline alcohol consumption. Results: The retention rate at 6-month follow-up was 80%. The data were not missing completely at random with differences detected in educational qualifications, occupation and income, indicating that multiple imputation was the most appropriate analytic approach. This found that Drink Less resulted in a 2.00 United Kingdom unit greater weekly reduction (95% confidence interval −3.76 to −0.24) at 6-month follow-up compared with the National Health Service alcohol advice web page. Compared with the National Health Service alcohol advice web page, Drink Less cost an additional £1.28 per user, when including the sunk costs (already incurred and cannot be recovered), but saved £0.04 per user when considering only the annual maintenance costs. Drink Less costs only an extra £0.64 per additional weekly unit of alcohol reduction, and may be cost saving if sufficient people use the app to cover the sunk costs. There was no statistically significant difference in quality-adjusted life-years between the two groups. Limitations: This trial relied on retrospective self-reported alcohol consumption. Results from the pre-registered sensitivity analysis of multiple imputation were inconsistent with those from the pre-registered primary analysis (a conservative approach to missing data where non-responders were assumed to be drinking at baseline levels), which found a non-significant weekly reduction of 0.98 units (95% confidence interval −2.67 to 0.70) in the intervention compared with comparator group. Multiple imputation was recommended by the independent Data Monitoring Committee based on the pattern of missing data. Conclusions: Drink Less appears effective for reducing alcohol consumption among increasing-and-higher-risk drinkers compared with the National Health Service alcohol advice web page in the United Kingdom, and may be cost saving if widely used in the population. Future work: Drink Less is in a strong position to be promoted widely and provide inexpensive support to increasing-and-higher-risk drinkers in the United Kingdom. Future work should investigate different promotion strategies and ways of implementing the app within healthcare settings and adapting it for other countries. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR127651.

Background: We compared the relative benefits, harms and cost-effectiveness of hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery ± systemic chemotherapy versus cytoreductive surgery ± systemic chemotherapy or systemic chemotherapy alone in people with peritoneal metastases from colorectal, gastric or ovarian cancers by a systematic review, meta-analysis and model-based cost–utility analysis. Methods: We searched MEDLINE, EMBASE, Cochrane Library and the Science Citation Index, ClinicalTrials.gov and WHO ICTRP trial registers until 14 April 2022. We included only randomised controlled trials addressing the research objectives. We used the Cochrane risk of bias tool version 2 to assess the risk of bias in randomised controlled trials. We used the random-effects model for data synthesis when applicable. For the cost-effectiveness analysis, we performed a model-based cost–utility analysis using methods recommended by The National Institute for Health and Care Excellence. Results: The systematic review included a total of eight randomised controlled trials (seven randomised controlled trials, 955 participants included in the quantitative analysis). All comparisons other than those for stage III or greater epithelial ovarian cancer contained only one trial, indicating the paucity of randomised controlled trials that provided data. For colorectal cancer, hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy probably results in little to no difference in all-cause mortality (60.6% vs. 60.6%; hazard ratio 1.00, 95% confidence interval 0.63 to 1.58) and may increase the serious adverse event proportions compared to cytoreductive surgery ± systemic chemotherapy (25.6% vs. 15.2%; risk ratio 1.69, 95% confidence interval 1.03 to 2.77). Hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy probably decreases all-cause mortality compared to fluorouracil-based systemic chemotherapy alone (40.8% vs. 60.8%; hazard ratio 0.55, 95% confidence interval 0.32 to 0.95). For gastric cancer, there is high uncertainty about the effects of hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy versus cytoreductive surgery + systemic chemotherapy or systemic chemotherapy alone on all-cause mortality. For stage III or greater epithelial ovarian cancer undergoing interval cytoreductive surgery, hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy probably decreases all-cause mortality compared to cytoreductive surgery + systemic chemotherapy (46.3% vs. 57.4%; hazard ratio 0.73, 95% confidence interval 0.57 to 0.93). Hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy may not be cost-effective versus cytoreductive surgery + systemic chemotherapy for colorectal cancer but may be cost-effective for the remaining comparisons. Limitations: We were unable to obtain individual participant data as planned. The limited number of randomised controlled trials for each comparison and the paucity of data on health-related quality of life mean that the recommendations may change as new evidence (from trials with a low risk of bias) emerges. Conclusions: In people with peritoneal metastases from colorectal cancer with limited peritoneal metastases and who are likely to withstand major surgery, hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy should not be used in routine clinical practice (strong recommendation). There is considerable uncertainty as to whether hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy or cytoreductive surgery + systemic chemotherapy should be offered to patients with gastric cancer and peritoneal metastases (no recommendation). Hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy should be offered routinely to women with stage III or greater epithelial ovarian cancer and metastases confined to the abdomen requiring and likely to withstand interval cytoreductive surgery after chemotherapy (strong recommendation). Future work: More randomised controlled trials are necessary. Study registration: This study is registered as PROSPERO CRD42019130504. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/135/02) and is published in full in Health Technology Assessment; Vol. 28, No. 51. See the NIHR Funding and Awards website for further award information.

Background: The extent to which interventions are perceived as acceptable to users impacts engagement and efficacy. Objective: In this study, we evaluated the acceptability of (1) the smartphone app Drink Less (intervention) and (2) the National Health Service (NHS) alcohol advice web page (usual digital care and comparator) among adult drinkers in the United Kingdom participating in a randomized controlled trial evaluating the effectiveness of the Drink Less app. Methods: A subsample of 26 increasing- and higher-risk drinkers (Alcohol Use Disorders Identification Test score≥8) assigned to the intervention group (Drink Less; n=14, 54%; female: n=10, 71%; age: 22-72 years; White: n=9, 64%) or usual digital care group (NHS alcohol advice web page; n=12, 46%; female: n=5, 42%; age: 23-68 years: White: n=9, 75%) took part in semistructured interviews. The interview questions were mapped on to the 7 facets of acceptability according to the Theoretical Framework of Acceptability: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. Alongside these constructs, we also included a question on perceived personal relevance, which previous research has linked to acceptability and engagement. Framework and thematic analysis of data was undertaken. Results: The Drink Less app was perceived as being ethical, easy, user-friendly, and effective for the period the app was used. Participants reported particularly liking the tracking and feedback sections of the app, which they reported increased personal relevance and which resulted in positive affect when achieving their goals. They reported no opportunity cost. Factors such as negative affect when not meeting goals and boredom led to disengagement in the longer term for some participants. The NHS alcohol advice web page was rated as being easy and user-friendly with no opportunity costs. However, the information presented was not perceived as being personally relevant or effective in changing drinking behavior. Most participants reported neutral or negative affect, most participants thought the alcohol advice web page was accessible, and some participants reported ethical concerns around the availability of suggested resources. Some participants reported that it had acted as a starting point or a signpost to other resources. Participants in both groups discussed motivation to change and contextual factors such as COVID-19 lockdowns, which influenced their perceived self-efficacy regardless of their assigned intervention. Conclusions: Drink Less appears to be an acceptable digital intervention among the recruited sample. The NHS alcohol advice web page was generally considered unacceptable as a stand-alone intervention among the recruited sample, although it may signpost and help people access other resources and interventions.