Cost-Effectiveness of the ACR TIRADS Compared to the ATA 2015 Risk Stratification Systems in the Evaluation of Incidental Thyroid Nodules.

RATIONALE AND OBJECTIVES: Thyroid nodules are a common incidental imaging finding and prone to overdiagnosis. Several risk stratification systems have been developed to reduce unnecessary work-up, with two of the most utilized including the American Thyroid Association 2015 (ATA2015) and the newer American College of Radiology Thyroid Imaging, Reporting and Data System (TIRADS) guidelines. The purpose of this study is to evaluate the cost-effectiveness of the ATA2015 versus the TIRADS guidelines in the management of incidental thyroid nodules. METHODS: A cost-utility analysis was conducted using decision tree modeling, evaluating adult patients with incidental thyroid nodules < 4 cm. Model inputs were populated using published literature, observational data, and expert opinion. Single-payer perspective, Canadian dollar currency, five-year time horizon, willingness to pay (WTP) threshold of $50,000, and discount rate of 1.5% per annum were utilized. Scenario, deterministic and probabilistic sensitivity analyses were performed. The primary outcome was the incremental cost-effectiveness ratio (ICER) expressed as incremental cost per quality-adjusted life year (QALY) gained. RESULTS: For the base case scenario, TIRADS dominated the ATA2015 strategy by a slim margin, producing 0.005 more QALYs at $25 less cost. Results were sensitive to the malignancy rate of biopsy and the utilities of a patient with a benign nodule/subclinical malignancy or under surveillance. Probabilistic sensitivity analysis showed that TIRADS was the more cost-effective option 79.7% of the time. CONCLUSION: The TIRADS guidelines may be the more cost-effective strategy by a small margin compared to ATA2015 in most scenarios when used to risk stratify incidental thyroid nodules.

How to Use Quasi-Experimental Methods in Cardiovascular Research: A Review of Current Practice.

BACKGROUND: Quasi-experimental methods (QEMs) are a family of techniques used to estimate causal relationships when randomized controlled trials are unfeasible or unethical. They offer a powerful alternative to observational studies by introducing random assignment of individuals or groups into their design, thereby offering stronger means of establishing causation. The use of QEMs in cardiovascular research has not been systematically examined to determine steps toward improving and expanding their use. METHODS: We identified 4 main techniques using a systematic search strategy from 2016 to 2021: instrumental variable analysis, interrupted time series analysis, difference-in-differences analysis, and regression discontinuity designs. QEMs are examined as alternatives to randomized controlled trials and traditional observational studies; as more observational data becomes available to researchers, there are more opportunities to apply these techniques. Eligible articles were selected based on publication in high-ranked journals. The quality of eligible articles was appraised using the Joanna Briggs Institute checklist for quasi-experimental studies. RESULTS: Data from 380 studies were extracted based on our inclusion criteria. Forty-two of these studies were published in the top 10 medical or top 20 cardiovascular disease journals, and 25 studies were included after quality appraisal. The review identifies the main features and limitations associated with each technique, providing readers with practical guidance on how to apply these to their research. A graphical decision aid was developed to facilitate the routine use of QEMs. CONCLUSIONS: The use of QEMs in cardiovascular research published in contemporary, high-impact articles was examined. Findings are biased toward this segment of literature, which represents the latest developments in this growing area of cardiovascular research. The decision aid is a novel schematic that researchers can adopt into practice.

Scenario development for safety assessment in deep geologic disposal of high-level radioactive waste and spent nuclear fuel: A review.

Radiation and radioactive substances result in the production of radioactive wastes which require safe management and disposal to avoid risks to human health and the environment. To ensure permanent safe disposal, the performance of a deep geological repository for radioactive waste is assessed against internationally agreed risk-based standards. Assessing postclosure safety of the future system's evolution includes screening of features, events, and processes (FEPs) relevant to the situation, their subsequent development into scenarios, and finally the development and execution of safety assessment (SA) models. Global FEP catalogs describe important natural and man-made repository system features and identify events and processes that may affect these features into the future. By combining FEPs, many of which are uncertain, different possible future system evolution scenarios are derived. Repository licensing should consider both the reference or "base" evolution as well as alternative futures that may lead to radiation release, pollution, or exposures. Scenarios are used to derive and consider both base and alternative evolutions, often through production of scenario-specific SA models and the recombination of their results into an assessment of the risk of harm. While the FEP-based scenario development process outlined here has evolved somewhat since its development in the 1980s, the fundamental ideas remain unchanged. A spectrum of common approaches is given here (e.g., bottom-up vs. top-down scenario development, probabilistic vs. bounding handling of uncertainty), related to how individual numerical models for possible futures are converted into a determination as to whether the system is safe (i.e., how aleatoric uncertainty and scenarios are integrated through bounding or Monte Carlo approaches).

Binding of Pentagalloyl Glucose to Aortic Wall Proteins: Insights from Peptide Mapping and Simulated Docking Studies.

Pentagalloyl glucose (PGG) is currently being investigated as a non-surgical treatment for abdominal aortic aneurysms (AAAs); however, the molecular mechanisms of action of PGG on the AAA matrix components and the intra-luminal thrombus (ILT) still need to be better understood. To assess these interactions, we utilized peptide fingerprinting and molecular docking simulations to predict the binding of PGG to vascular proteins in normal and aneurysmal aorta, including matrix metalloproteinases (MMPs), cytokines, and fibrin. We performed PGG diffusion studies in pure fibrin gels and human ILT samples. PGG was predicted to bind with high affinity to most vascular proteins, the active sites of MMPs, and several cytokines known to be present in AAAs. Finally, despite potential binding to fibrin, PGG was shown to diffuse readily through thrombus at physiologic pressures. In conclusion, PGG can bind to all the normal and aneurysmal aorta protein components with high affinity, potentially protecting the tissue from degradation and exerting anti-inflammatory activities. Diffusion studies showed that thrombus presence in AAAs is not a barrier to endovascular treatment. Together, these results provide a deeper understanding of the clinical potential of PGG as a non-surgical treatment of AAAs.

Process analysis of the patient pathway for automated data collection: an exemplar using pituitary surgery.

Introduction: Automation of routine clinical data shows promise in relieving health systems of the burden associated with manual data collection. Identifying consistent points of documentation in the electronic health record (EHR) provides salient targets to improve data entry quality. Using our pituitary surgery service as an exemplar, we aimed to demonstrate how process mapping can be used to identify reliable areas of documentation in the patient pathway to target structured data entry interventions. Materials and methods: This mixed methods study was conducted in the largest pituitary centre in the UK. Purposive snowball sampling identified frontline stakeholders for process mapping to produce a patient pathway. The final patient pathway was subsequently validated against a real-world dataset of 50 patients who underwent surgery for pituitary adenoma. Events were categorized by frequency and mapped to the patient pathway to determine critical data points. Results: Eighteen stakeholders encompassing all members of the multidisciplinary team (MDT) were consulted for process mapping. The commonest events recorded were neurosurgical ward round entries (N = 212, 14.7%), pituitary clinical nurse specialist (CNS) ward round entries (N = 88, 6.12%) and pituitary MDT treatment decisions (N = 88, 6.12%) representing critical data points. Operation notes and neurosurgical ward round entries were present for every patient. 43/44 (97.7%) had a pre-operative pituitary MDT entry, pre-operative clinic letter, a post-operative clinic letter, an admission clerking entry, a discharge summary, and a post-operative histopathology pituitary multidisciplinary (MDT) team entries. Conclusion: This is the first study to produce a validated patient pathway of patients undergoing pituitary surgery, serving as a comparison to optimise this patient pathway. We have identified salient targets for structured data entry interventions, including mandatory datapoints seen in every admission and have also identified areas to improve documentation adherence, both of which support movement towards automation.

Clinical negligence cases in the English NHS: uncertainty in evidence as a driver of settlement costs and societal outcomes.

The cost of clinical negligence claims continues to rise, despite efforts to reduce this now ageing burden to the National Health Service (NHS) in England. From a welfarist perspective, reforms are needed to reduce avoidable harm to patients and to settle claims fairly for both claimants and society. Uncertainty in the estimation of quanta of damages, better known as financial settlements, is an important yet poorly characterised driver of societal outcomes. This reflects wider limitations to evidence informing clinical negligence policy, which has been discussed in recent literature. There is an acute need for practicable, evidence-based solutions that address clinical negligence issues, and these should complement long-standing efforts to improve patient safety. Using 15 claim cases from one NHS Trust between 2004 and 2016, the quality of evidence informing claims was appraised using methods from evidence-based medicine. Most of the evidence informing clinical negligence claims was found to be the lowest quality possible (expert opinion). The extent to which the quality of evidence represents a normative deviance from scientific standards is discussed. To address concerns about the level of uncertainty involved in deriving quanta, we provide five recommendations for medico-legal stakeholders that are designed to reduce avoidable bias and correct potential market failures.

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.

Impact of providing patients access to electronic health records on quality and safety of care: a systematic review and meta-analysis.

OBJECTIVE: To evaluate the impact of sharing electronic health records (EHRs) with patients and map it across six domains of quality of care (ie, patient-centredness, effectiveness, efficiency, timeliness, equity and safety). DESIGN: Systematic review and meta-analysis. DATA SOURCES: CINAHL, Cochrane, Embase, HMIC, Medline/PubMed and PsycINFO, from 1997 to 2017. ELIGIBILITY CRITERIA: Randomised trials focusing on adult subjects, testing an intervention consisting of sharing EHRs with patients, and with an outcome in one of the six domains of quality of care. DATA ANALYSIS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Title and abstract screening were performed by two pairs of investigators and assessed using the Cochrane Risk of Bias Tool. For each domain, a narrative synthesis of the results was performed, and significant differences in results between low risk and high/unclear risk of bias studies were tested (t-test, p<0.05). Continuous outcomes evaluated in four studies or more (glycated haemoglobin (HbA1c), systolic blood pressure (SBP) and diastolic blood pressure (DBP)) were pooled as weighted mean difference (WMD) using random effects meta-analysis. Sensitivity analyses were performed for low risk of bias studies, and long-term interventions only (lasting more than 12 months). RESULTS: Twenty studies were included (17 387 participants). The domain most frequently assessed was effectiveness (n=14), and the least were timeliness and equity (n=0). Inconsistent results were found for patient-centredness outcomes (ie, satisfaction, activation, self-efficacy, empowerment or health literacy), with 54.5% of the studies (n=6) demonstrating a beneficial effect. Meta-analyses showed a beneficial effect in effectiveness by reducing absolute values of HbA1c (unit: %; WMD=-0.316; 95% CI -0.540 to -0.093, p=0.005, I2=0%), which remained significant in the sensitivity analyses for low risk of bias studies (WMD= -0.405; 95% CI -0.711 to -0.099), and long-term interventions only (WMD=-0.272; 95% CI -0.482 to -0.062). A significant reduction of absolute values of SBP (unit: mm Hg) was found but lost in sensitivity analysis for studies with low risk of bias (WMD= -1.375; 95% CI -2.791 to 0.041). No significant effect was found for DBP (unit: mm Hg; WMD=-0.918; 95% CI -2.078 to 0.242, p=0.121, I2=0%). Concerning efficiency, most studies (80%, n=4) found either a reduction of healthcare usage or no change. A beneficial effect was observed in a range of safety outcomes (ie, general adherence, medication safety), but not in medication adherence. The proportion of studies reporting a beneficial effect did not differ between low risk and high/unclear risk studies, for the domains evaluated. DISCUSSION: Our analysis supports that sharing EHRs with patients is effective in reducing HbA1c levels, a major predictor of mortality in type 2 diabetes (mean decrease of -0.405, unit: %) and could improve patient safety. More studies are necessary to enhance meta-analytical power and assess the impact in other domains of care. PROTOCOL REGISTRATION: http://www.crd.york.ac.uk/PROSPERO (CRD42017070092).

What are the requirements for developing a successful national registry of auditory implants? A qualitative study.

OBJECTIVES: Hearing loss is an area of unmet need, and industry is targeting this field with a growing range of surgically implanted hearing devices. Currently, there is no comprehensive UK registry capturing data on these devices; in its absence, it is difficult to monitor clinical and cost-effectiveness and develop national policy. Recognising that developing such a registry faces considerable challenges, it is important to gather opinions from stakeholders and patients. This paper builds on our systematic review on surgical registry development and aims to identify the specific requirements for developing a successful national registry of auditory implants. DESIGN: Qualitative study. PARTICIPANTS: Data were collected in two ways: (1) semistructured interviews with UK professional stakeholders; and (2) focus groups with patients with hearing loss. The interview and focus group schedules were informed by our systematic review on registry development. Data were analysed using directed content analysis. Judges mapped the themes obtained against a conceptual framework developed from our systematic review on registry development. The conceptual framework consisted of five categories for successful registry development: (1) planning, (2) registry governance, (3) registry dataset, (4) anticipating challenges, (5) implementing solutions. RESULTS: Twenty-seven themes emerged from 40 semistructured interviews with professional stakeholders and 18 themes emerged from three patient focus groups. The most important factor for registry success was high rates of data completion. Benefits of developing a successful registry of auditory implants include: strengthening the evidence base and regulation of auditory implants, driving quality and safety improvements, increased transparency, facilitating patient decision-making and informing policy and guidelines development. CONCLUSIONS: This study identifies the requirements for developing a successful national registry of auditory implants, benefiting from the involvement of numerous professional stakeholder groups and patients with hearing loss. Our approach may be used internationally to inform successful registry development.

Impact of sharing electronic health records with patients on the quality and safety of care: a systematic review and narrative synthesis protocol.

INTRODUCTION: Providing patients with access to electronic health records (EHRs) has emerged as a promising solution to improve quality of care and safety. As the efforts to develop and implement EHR-based data sharing platforms mature and scale up worldwide, there is a need to evaluate the impact of these interventions and to weigh their relative risks and benefits, in order to inform evidence-based health policies. The aim of this work is to systematically characterise and appraise the demonstrated benefits and risks of sharing EHR with patients, by mapping them across the six domains of quality of care of the Institute of Medicine (IOM) analytical framework (ie, patient-centredness, effectiveness, efficiency, timeliness, equity and safety). METHODS AND ANALYSIS: CINAHL, Cochrane, Embase, HMIC, Medline/PubMed and PsycINFO databases will be searched from January 1997 to August 2017. Primary outcomes will include measures related with the six domains of quality of care of the IOM analytical framework. The quality of the studies will be assessed using the Cochrane Risk of Bias Tool, the ROBINS-I Tool and the Drummond's checklist. A narrative synthesis will be conducted for all included studies. Subgroup analysis will be performed by domain of quality of care domain and by time scale (ie, short-term, medium-term or long-term impact). The body of evidence will be summarised in a Summary of Findings table and its strength assessed according to the GRADE criteria. ETHICS AND DISSEMINATION: This review does not require ethical approval as it will summarise published studies with non-identifiable data. This protocol complies with the Preferred Reporting Items for Systematic Review and Meta-Analyses Protocols guidelines. Findings will be disseminated widely through peer-reviewed publication and conference presentations, and patient partners will be included in summarising the research findings into lay summaries and reports. PROSPERO REGISTRATION NUMBER: CRD42017070092.

Global Lessons In Frugal Innovation To Improve Health Care Delivery In The United States.

In a 2015 global study of low-cost or frugal innovations, we identified five leading innovations that scaled successfully in their original contexts and that may provide insights for scaling such innovations in the United States. We describe common themes among these diverse innovations, critical factors for their translation to the United States to improve the efficiency and quality of health care, and lessons for the implementation and scaling of other innovations. We highlight promising trends in the United States that support adapting these innovations, including growing interest in moving care out of health care facilities and into community and home settings; the growth of alternative payment models and incentives to experiment with new approaches to population health and care delivery; and the increasing use of diverse health professionals, such as community health workers and advanced practice providers. Our findings should inspire policy makers and health care professionals and inform them about the potential for globally sourced frugal innovations to benefit US health care.

Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence.

INTRODUCTION: Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. METHODS AND ANALYSIS: A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in 'patient safety' and 'economic analyses' has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. ETHICS AND DISSEMINATION: Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, presentations and social media. TRIAL REGISTRATION NUMBER: CRD42017057853.

Estimating the incidence and the economic burden of third and fourth-degree obstetric tears in the English NHS: an observational study using propensity score matching.

OBJECTIVE: Obstetric care is a high-risk area in healthcare delivery, so it is essential to have up-to-date quantitative evidence in this area to inform policy decisions regarding these services. In light of this, the objective of this study is to investigate the incidence and economic burden of third and fourth-degree lacerations in the English National Health Service (NHS) using recent national data. METHODS: We used coded inpatient data from Hospital Episode Statistics (HES) for the financial years from 2010/2011 to 2013/2014 for all females that gave birth during that period in the English NHS. Using HES, we used pre-existing safety indicator algorithms to calculate the incidence of third and fourth-degree obstetric tears and employed a propensity score matching method to estimate the excess length of stay and economic burden associated with these events. RESULTS: Observed rates per 1000 inpatient episodes in 2010/2011 and 2013/2014, respectively: Patient Safety Indicator-trauma during vaginal delivery with instrument (PSI 18)=84.16 and 91.24; trauma during vaginal delivery without instrument (PSI 19)=29.78 and 33.43; trauma during caesarean delivery (PSI 20)=3.61 and 4.56. Estimated overall (all PSIs) economic burden for 2010/2011=£10.7 million and for 2013/2014=£14.5 million, expressed in 2013/2014 prices. CONCLUSIONS: Despite many initiatives targeting the quality of maternity care in the NHS, the incidence of third and fourth-degree lacerations has increased during the observed period which signals that quality improvement efforts in obstetric care may not be reducing incidence rates. Our conservative estimates of the financial burden of these events appear low relative to total NHS expenditure for these years.

A national incident reporting and learning system in England and Wales, but at what cost?

Recent high-profile failures in healthcare highlight the ongoing need for improvements in patient safety. Moreover, the fiscal challenge facing many health systems has brought the costs and economic efficiencies associated with improving quality (and safety) to bear. Currently, there is a lack of economic evidence underpinning resource allocation decisions in patient safety. Incident reporting systems are considered an important means of addressing these challenges by monitoring incident rates over time, identifying new threats to patient care and ultimately preventing repetition of costly adverse events. Uniquely, for more than a decade, the UK has been developing a National Reporting and Learning System to provide these functions for the English and Welsh health system(s), in addition to pre-existing local systems. The need to evaluate the impact of national incident reporting, and learning systems in terms of effectiveness and efficiency is argued and the methodological challenges that must be considered in an economic analysis are outlined.

The methodological quality of health economic evaluations for the management of hip fractures: A systematic review of the literature.

BACKGROUND AND OBJECTIVES: Approximately 76,000 people a year sustain a hip fracture in the UK and the estimated cost to the NHS is £1.4 billion a year. Health economic evaluations (HEEs) are one of the methods employed by decision makers to deliver healthcare policy supported by clinical and economic evidence. The objective of this study was to (1) identify and characterize HEEs for the management of patients with hip fractures, and (2) examine their methodological quality. METHODS: A literature search was performed in MEDLINE, EMBASE and the NHS Economic Evaluation Database. Studies that met the specified definition for a HEE and evaluated hip fracture management were included. Methodological quality was assessed using the Consensus on Health Economic Criteria (CHEC). RESULTS: Twenty-seven publications met the inclusion criteria of this study and were included in our descriptive and methodological analysis. Domains of methodology that performed poorly included use of an appropriate time horizon (66.7% of studies), incremental analysis of costs and outcomes (63%), future discounting (44.4%), sensitivity analysis (40.7%), declaration of conflicts of interest (37%) and discussion of ethical considerations (29.6%). CONCLUSIONS: HEEs for patients with hip fractures are increasing in publication in recent years. Most of these studies fail to adopt a societal perspective and key aspects of their methodology are poor. The development of future HEEs in this field must adhere to established principles of methodology, so that better quality research can be used to inform health policy on the management of patients with a hip fracture.