The avoiding late diagnosis of ovarian cancer (ALDO) project; a pilot national surveillance programme for women with pathogenic germline variants in BRCA1 and BRCA2.

BACKGROUND: Our study aimed to establish 'real-world' performance and cost-effectiveness of ovarian cancer (OC) surveillance in women with pathogenic germline BRCA1/2 variants who defer risk-reducing bilateral salpingo-oophorectomy (RRSO). METHODS: Our study recruited 875 female BRCA1/2-heterozygotes at 13 UK centres and via an online media campaign, with 767 undergoing at least one 4-monthly surveillance test with the Risk of Ovarian Cancer Algorithm (ROCA) test. Surveillance performance was calculated with modelling of occult cancers detected at RRSO. The incremental cost-effectiveness ratio (ICER) was calculated using Markov population cohort simulation. RESULTS: Our study identified 8 OCs during 1277 women screen years: 2 occult OCs at RRSO (both stage 1a), and 6 screen-detected; 3 of 6 (50%) were ≤stage 3a and 5 of 6 (83%) were completely surgically cytoreduced. Modelled sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) for OC were 87.5% (95% CI, 47.3 to 99.7), 99.9% (99.9-100), 75% (34.9-96.8) and 99.9% (99.9-100), respectively. The predicted number of quality-adjusted life years (QALY) gained by surveillance was 0.179 with an ICER cost-saving of -£102,496/QALY. CONCLUSION: OC surveillance for women deferring RRSO in a 'real-world' setting is feasible and demonstrates similar performance to research trials; it down-stages OC, leading to a high complete cytoreduction rate and is cost-saving in the UK National Health Service (NHS) setting. While RRSO remains recommended management, ROCA-based surveillance may be considered for female BRCA-heterozygotes who are deferring such surgery.

Uncovering the treatable burden of severe aortic stenosis in the UK.

OBJECTIVE: To estimate the population prevalence and treatable burden of severe aortic stenosis (AS) in the UK. METHODS: We adapted a contemporary model of the population profile of symptomatic and asymptomatic severe AS in Europe and North America to estimate the number of people aged ≥55 years in the UK who might benefit from surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI). RESULTS: With a point prevalence of 1.48%, we estimate that 291 448 men and women aged ≥55 years in the UK had severe AS in 2019. Of these, 68.3% (199 059, 95% CI 1 77 201 to 221 355 people) would have been symptomatic and, therefore, more readily treated according to their surgical risk profile; the remaining 31.7% of cases (92 389, 95% CI 70 093 to 144 247) being asymptomatic. Based on historical patterns of intervention, 58.4% (116 251, 95% CI 106 895 to 1 25 606) of the 199 059 symptomatic cases would qualify for SAVR, with 7208 (95% CI 7091 to 7234) being assessed as being in a high, preoperative surgical risk category. Among the remaining 41.6% (82 809, 95% CI 73 453 to 92 164) of cases potentially unsuitable for SAVR, an estimated 61.7% (51 093, 95% CI 34 780 to 67 655) might be suitable for TAVI. We estimate that 172 859 out of 291 448 prevalent cases of severe AS (59.3%) will subsequently die within 5 years without proactive management. CONCLUSIONS: These data suggest a high burden of severe AS in the UK requiring surgical or transcatheter intervention that challenges the ongoing capacity of the National Health Service to meet the needs of those affected.

A clinical and cost-effectiveness analysis of the HeartMate 3 left ventricular assist device for transplant-ineligible patients: A United Kingdom perspective.

BACKGROUND: The clinical and cost-effectiveness of left ventricular assist device (LVAD) therapy for patients with advanced heart failure (HF) who are ineligible for heart transplantation is debated in the UK. This study develops an indirect comparison between the fully magnetically levitated HeartMate 3 (HM 3) LVAD and medical therapy (MT) to evaluate expected clinical and cost-effectiveness in the UK National Health Service (NHS) context. METHODS: We performed an economic analysis comparing the HM3 pump against the HeartMate II LVAD (MOMENTUM 3), and then another analysis comparing MT with the first- and second-generation HeartMate XVE pump LVAD and HeartMate II LVAD for the same patient population (REMATCH and ROADMAP, respectively). By bridging those 2 analyses, an indirect comparison between HM3 and MT in the form of a network meta-analysis was developed. A literature search was performed to select the most appropriate pair of studies for this purpose. Outcomes were adjusted to produce Kaplan-Meier curves for the cost-effectiveness evaluation by using a decision-analytic model. Data were extrapolated linearly over a 5-year time horizon. Uncertainty and additional scenarios were addressed by one-way and probabilistic sensitivity analysis. Local costs and health utility were used from England, thereby representing the UK context. RESULTS: The incremental cost-effectiveness ratio (ICER) for LVAD vs MT in transplant ineligible patients with advanced HF was estimated to be £47,361 per quality-adjusted life year gained, with a 97.1% probability of being cost-effective at £50,000. In a subgroup of patients who are inotropic therapy dependent (INTERMACS 1-3 severity profile), the ICER was £45,616, while for a population with less-ill ambulatory HF (INTERMACS profile 4-7) the ICER changed to £64,051. CONCLUSIONS: This study provides evidence that HM3 LVAD therapy in advanced HF patients ineligible for heart transplantation may be cost-effective compared to MT in the NHS UK-England context. The ICER is lowest for patients dependent on inotropic support, but exceeds the willingness to pay threshold of £50,000 in ambulatory noninotropic therapy dependent advanced HF patients.

An early cost analysis of magnetic bone growth stimulation in England.

BACKGROUND: Fracture nonunions impact on morbidity and health care costs and are associated with substantial pain, reduced mobility, prolonged morbidity, and a lower quality of life. CMF OrthoLogic 1000 (OL1000) is a bone growth stimulator used to promote fracture healing potentially reducing the need for surgical intervention. A cost analysis comparing CMF OL1000 versus surgical care for patients with nonunion tibial fractures was conducted. METHODS: A Markov model was developed to compare the difference in costs between CMF OL1000 versus surgical care within the English National Health Service over a 2-year time horizon. The effectiveness of CMF OL1000 was based on recently published registry data. Cost data were derived from published sources and national cost databases. Sensitivity and scenario analyses were conducted. RESULTS: The use of CMF OL1000 is estimated to lead to cost-savings of £1,104 per patient, a reduction in average healing time of 2.1 months and a relative risk of infection of 0.19 compared to immediate surgical intervention (standard of care). The results of the model are robust to most changes in input parameters and scenarios considered. CONCLUSIONS: This early analysis shows cost-savings for CMF OL1000 compared with surgical intervention for individuals with nonunion tibial fractures.

Accounting for inflation within NICE cost-effectiveness thresholds.

BACKGROUND: The National Institute for Health and Care Excellence (NICE) makes recommendations on the reimbursement of new drugs utilizing an Incremental Cost-Effectiveness Ratio (ICER) threshold range that has been in use since 2004 and has remained unchanged. RESEARCH DESIGN AND METHODS: To model how the NICE cost-effectiveness thresholds would vary if inflation was accounted for and their potential effects on appraisal outcomes, all single technology appraisal (STA) recommendations published in 2019 were identified. The outcome and most plausible ICERs were then evaluated against thresholds, after taking inflation into account. RESULTS: 41 STAs with base-case ICERs were identified. For general STAs, 46% of ICERs were ≤£20,000/QALY, 27% were £20,000-£30,000/QALY and 27% >£30,000/QALY. Cumulatively, there was a 43% decrease in the purchasing power of the pound from 2004 to 2019 due to inflation. To compensate, the NICE ICER threshold would have to increase to £28,584-£42,876/QALY. Using inflation-adjusted thresholds led to an absolute increase of 18% and 12% of STAs whose ICERs fell below the lower and upper bounds of this threshold range, respectively. CONCLUSION: By not adjusting for inflation, the NICE ICER thresholds have declined in real terms. Whether ICER thresholds should be dynamic to reflect factors like inflation requires further research.

Rectal foreign body removal: increasing incidence and cost to the NHS.

INTRODUCTION: Insertion of foreign objects into the rectum is a well-described phenomenon and not an uncommon referral to the general surgeon on call. Although usually not life-threatening, there can be consequences following migration of the object or perforation of the large bowel. This study looks at the incidence of removal of foreign objects from the rectum over the last decade and the financial burden it presents to the NHS. METHODS: Hospital Episode Statistics for 2010-2019 were used to calculate the number of rectal foreign bodies that required removal in hospital. Data for age groups and genders have been compared. RESULTS: A total of 3,500 rectal foreign bodies were removed over the course of 9 years. Males accounted for 85.1% of rectal foreign bodies whilst 14.9% were females. This equates to 348 bed-days per annum. Admission peaks were observed in the second and fifth decades of life. CONCLUSION: This study shows that the incidence of rectal foreign bodies is higher in men and has been increasing over the period studied. Most foreign bodies can be removed trans-anally with the use of anaesthesia, with only a small proportion of patients requiring hospital stay over 24 hours (mean length of stay = 24 hours). Nearly 400 rectal foreign body removals are performed each year with an annual cost of £338,819, illustrating the effect this has on NHS resources.

Special Low Protein Foods Prescribed in England for PKU Patients: An Analysis of Prescribing Patterns and Cost.

Patients with phenylketonuria (PKU) are reliant on special low protein foods (SLPFs) as part of their dietary treatment. In England, several issues regarding the accessibility of SLPFs through the national prescribing system have been highlighted. Therefore, prescribing patterns and expenditure on all SLPFs available on prescription in England (n = 142) were examined. Their costs in comparison to regular protein-containing (n = 182) and 'free-from' products (n = 135) were also analysed. Similar foods were grouped into subgroups (n = 40). The number of units and costs of SLPFs prescribed in total and per subgroup from January to December 2020 were calculated using National Health Service (NHS) Business Service Authority (NHSBSA) ePACT2 (electronic Prescribing Analysis and Cost Tool) for England. Monthly patient SLPF units prescribed were calculated using patient numbers with PKU and non-PKU inherited metabolic disorders (IMD) consuming SLPFs. This was compared to the National Society for PKU (NSPKU) prescribing guidance. Ninety-eight percent of SLPF subgroups (n = 39/40) were more expensive than regular and 'free-from' food subgroups. However, costs to prescribe SLPFs are significantly less than theoretical calculations. From January to December 2020, 208,932 units of SLPFs were prescribed (excluding milk replacers), costing the NHS £2,151,973 (including milk replacers). This equates to £962 per patient annually, and prescribed amounts are well below the upper limits suggested by the NSPKU, indicating under prescribing of SLPFs. It is recommended that a simpler and improved system should be implemented. Ideally, specialist metabolic dietitians should have responsibility for prescribing SLPFs. This would ensure that patients with PKU have the necessary access to their essential dietary treatment, which, in turn, should help promote dietary adherence and improve metabolic control.

The Effect of National Health Service Corps Clinician Staffing on Medical and Behavioral Health Care Costs in Community Health Centers.

OBJECTIVE: Prior studies of community health centers (CHCs) have found that clinicians supported by the National Health Service Corps (NHSC) provide a comparable number of primary care visits per full-time clinician as non-NHSC clinicians and provide more behavioral health care visits per clinician than non-NHSC clinicians. This present study extends prior research by examining the contribution of NHSC and non-NHSC clinicians to medical and behavioral health costs per visit. METHODS: Using 2013-2017 data from 1022 federally qualified health centers merged with the NHSC participant data, we constructed multivariate linear regression models with health center and year fixed effects to examine the marginal effect of each additional NHSC and non-NHSC staff full-time equivalent (FTE) on medical and behavioral health care costs per visit in CHCs. RESULTS: On average, each additional NHSC behavioral health staff FTE was associated with a significant reduction of 3.55 dollars of behavioral health care costs per visit in CHCs and was associated with a larger reduction of 7.95 dollars in rural CHCs specifically. In contrast, each additional non-NHSC behavioral health staff FTE did not significantly affect changes in behavioral health care costs per visit. Each additional NHSC primary care staff FTE was not significantly associated with higher medical care costs per visit, while each additional non-NHSC clinician contributed to a slight increase of $0.66 in medical care costs per visit. CONCLUSIONS: Combined with previous findings on productivity, the present findings suggest that the use of NHSC clinicians is an effective approach to improving the capacity of CHCs by increasing medical and behavioral health care visits without increasing costs of services in CHCs, including rural health centers.

Malpractice litigation and spinal surgery in the National Health Service: a single tertiary-level centre perspective over 12 years.

INTRODUCTION: Medical malpractice litigation is a major concern for all spine surgeons. Our aim was to evaluate the incidence and burden of successful litigation relating to the management of spinal disorders over 12 years within a UK NHS tertiary-level spinal unit and compare these litigation costs with those of other specialties. METHODS: We obtained all data held by our claims department from its inception in January 2008 to December 2019. We also obtained costs for the total financial burden incurred by our Trust during this period. RESULTS: In total, there were 83 closed claims involving spinal pathologies. Over 80% of these comprised negligent surgery (n = 28, 34%), delay to diagnose/treat (n = 25, 30%) and negligent care (n = 18, 22%). The vast majority of claims were withdrawn without incurring any cost to the hospital (n = 59, 71%) and only 24 (29%) resulted in successful litigation for the claimant. The total cost of damages for these 24 successful claims was just over £8 million, including legal costs of £2.5 million, out of total litigation costs of £381 million over this period. DISCUSSION: Fewer than 30% of initial claims against a tertiary spinal surgical referral unit resulted in a successful financial outcome for the claimant. The total costs incurred were just over £8 million, with one-third apportioned to high legal costs, reflecting the complexity of resolving spinal litigation. Our entire legal expenses accounted for only 2% of the total legal bill paid by our hospital over a 12-year period.

The CAPACITI Decision-Support Tool for National Immunization Programs.

OBJECTIVES: Immunization programs in low-income and middle-income countries (LMICs) are faced with an ever-growing number of vaccines of public health importance recommended by the World Health Organization, while also financing a greater proportion of the program through domestic resources. More than ever, national immunization programs must be equipped to contextualize global guidance and make choices that are best suited to their setting. The CAPACITI decision-support tool has been developed in collaboration with national immunization program decision makers in LMICs to structure and document an evidence-based, context-specific process for prioritizing or selecting among multiple vaccination products, services, or strategies. METHODS: The CAPACITI decision-support tool is based on multi-criteria decision analysis, as a structured way to incorporate multiple sources of evidence and stakeholder perspectives. The tool has been developed iteratively in consultation with 12 countries across Africa, Asia, and the Americas. RESULTS: The tool is flexible to existing country processes and can follow any type of multi-criteria decision analysis or a hybrid approach. It is structured into 5 sections: decision question, criteria for decision making, evidence assessment, appraisal, and recommendation. The Excel-based tool guides the user through the steps and document discussions in a transparent manner, with an emphasis on stakeholder engagement and country ownership. CONCLUSIONS: Pilot countries valued the CAPACITI decision-support tool as a means to consider multiple criteria and stakeholder perspectives and to evaluate trade-offs and the impact of data quality. With use, it is expected that LMICs will tailor steps to their context and streamline the tool for decision making.

The importance of investing in early years health and social care.

Emeritus Professor Alan Glasper, from the University of Southampton, discusses the focus of a new initiative to improve early years health and social care, launched by the Duchess of Cambridge.