21 results found
Carter AW, Jayawardana S, Costa-Font J, et al., 2024, How to Use Quasi-Experimental Methods in Cardiovascular Research: A Review of Current Practice., Circ Cardiovasc Qual Outcomes, Vol: 17
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.
Carter AW, Mossialos E, Redhead J, et al., 2022, Clinical negligence cases in the English NHS: uncertainty in evidence as a driver of settlement costs and societal outcomes, HEALTH ECONOMICS POLICY AND LAW, Vol: 17, Pages: 266-281, ISSN: 1744-1331
Lim HS, Shaw S, Carter AW, et al., 2022, A clinical and cost-effectiveness analysis of the HeartMate 3 left ventricular assist device for transplant-ineligible patients: A United Kingdom perspective., J Heart Lung Transplant, Vol: 41, Pages: 174-186
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 c
Neves AL, Freise L, Laranjo L, et al., 2020, Impact of providing patients access to electronic health records on quality and safety of care: a systematic review and meta-analysis, BMJ Quality and Safety, Vol: 29, Pages: 1019-1032, ISSN: 2044-5415
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 s
Dilley J, Camara M, Omar I, et al., 2019, Evaluating the impact of image guidance in the surgical setting: A systematic review, Surgical Endoscopy, Vol: 33, Pages: 2785-2793, ISSN: 0930-2794
BACKGROUND: Image guidance has been clinically available for over a period of 20 years. Although research increasingly has a translational emphasis, overall the clinical uptake of image guidance systems in surgery remains low. The objective of this review was to establish the metrics used to report on the impact of surgical image guidance systems used in a clinical setting. METHODS: A systematic review of the literature was carried out on all relevant publications between January 2000 and April 2016. Ovid MEDLINE and Embase databases were searched using a title strategy. Reported outcome metrics were grouped into clinically relevant domains and subsequent sub-categories for analysis. RESULTS: In total, 232 publications were eligible for inclusion. Analysis showed that clinical outcomes and system interaction were consistently reported. However, metrics focusing on surgeon, patient and economic impact were reported less often. No increase in the quality of reporting was observed during the study time period, associated with study design, or when the clinical setting involved a surgical specialty that had been using image guidance for longer. CONCLUSIONS: Publications reporting on the clinical use of image guidance systems are evaluating traditional surgical outcomes and neglecting important human and economic factors, which are pertinent to the uptake, diffusion and sustainability of image-guided surgery. A framework is proposed to assist researchers in providing comprehensive evaluation metrics, which should also be considered in the design phase. Use of these would help demonstrate the impact in the clinical setting leading to increased clinical integration of image guidance systems.
Grant Y, Al-Khudairi R, St John E, et al., 2019, Patient-level costs in margin re-excision for breast-conserving surgery, British Journal of Surgery, Vol: 106, Pages: 384-394, ISSN: 1365-2168
BackgroundHigh rates of reoperation following breast‐conserving surgery (BCS) for positive margins are associated with costs to healthcare providers. The aim was to assess the quality of evidence on reported re‐excision costs and compare the direct patient‐level costs between patients undergoing successful BCS versus reoperations after BCS.MethodsThe study used data from women who had BCS with or without reoperation at a single institution between April 2015 and March 2016. A systematic review of health economic analysis in BCS was conducted and scored using the Quality of Health Economic Studies (QHES) instrument. Financial data were retrieved using the Patient‐Level Information and Costing Systems (PLICS) for patients. Exchange rates used were: US $1 = £0·75, £1 = €1·14 and US $1 = €0·85.ResultsThe median QHES score was 47 (i.q.r. 32·5–79). Only two of nine studies scored in the upper QHES quartile (score at least 75). Costs of initial lumpectomy and reoperation were in the range US $1234–11786 and $655–9136 respectively. Over a 12‐month interval, 153 patients had definitive BCS and 59 patients underwent reoperation. The median cost of reoperations after BCS (59 patients) was £4511 (range 1752–18 019), representing an additional £2136 per patient compared with BCS without reoperation (P < 0·001).ConclusionThe systematic review demonstrated variation in methodological approach to cost estimates and a paucity of high‐quality cost estimate studies for reoperations. Extrapolating local PLICS data to a national level suggests that getting BCS right first time could result in substantial savings.
Mandavia R, Knight A, Carter AW, et al., 2018, What are the requirements for developing a successful national registry of auditory implants? A qualitative study, BMJ OPEN, Vol: 8, ISSN: 2044-6055
Neves AL, Carter AW, Freise L, et al., 2018, Impact of sharing electronic health records with patients on the quality and safety of care: a systematic review and narrative synthesis protocol, BMJ Open, Vol: 8, ISSN: 2044-6055
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.
Grant Y, Al-Khudairi R, St John E, et al., 2018, Patient level costs of margin excision and re-excision for breast conserving surgery, Association of Breast Surgery 2018
Grant Y, St John E, Carter A, et al., 2018, Patient-level costs in margin excision for breast conserving surgery, ASBRS
bhatti Y, taylor A, harris M, et al., 2017, Global Lessons In Frugal Innovation To Improve Health Care Delivery In The United States, Health Affairs, Vol: 36, Pages: 1912-1919, ISSN: 0278-2715
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.
Bhatti Y, Prime M, Harris M, et al., 2017, The search for the Holy Grail -- frugal innovation in healthcare from developing countries for reverse innovation to developed countries, BMJ Innovations, Vol: 3, Pages: 212-220, ISSN: 2055-642X
The healthcare sector stands to benefit most from frugal innovation, the idea that more can be done for less for many more people, globally. As a first step for health systems to leverage new approaches to offset escalating health expenditures and to improve health outcomes, the most relevant frugal innovations have to be found. The Institute of Global Health Innovation was commissioned by the US-based Commonwealth Fund to identify frugal innovations from around the world that could, if transferred to the USA, offer approaches for expanding access to care and dramatically lower costs. Our global scan was motivated by the need to extend the list of frugal innovations in healthcare beyond the impressive but oft-repeated examples such as GE’s MAC 400, a US$800 portable ECG machine, Narayana’s US$1500 cardiac surgery and Aravind’s US$30 cataract surgery. Our search involved (1) scanning innovation databases, (2) refining frameworks to identify frugal innovations and evaluate their reverse potential and (3) developing in-depth case studies. From 520 possible innovations, we shortlisted 16 frugal innovations that we considered as frugal and with potential for reverse diffusion into high-income country health systems. Our global search was narrowed down to three care delivery models for case analysis: The Brazilian Family Health Strategy around community health workers; Singapore-based GeriCare@North use of telemedicine and Brazil’s Saude Crianca community involvement and citizenship programme. We share core features of the three frugal innovations and outline lessons for practitioners, scholars and policymakers seeking to lower healthcare costs while increasing access and quality.
Neves AL, Roy R, Wadge H, et al., 2017, A framework for evaluating the economic impact of EHR-based interventions
Mandavia R, Carter AW, Haram N, et al., 2017, An evaluation of the quality of evidence available to inform current bone conducting hearing device national policy, CLINICAL OTOLARYNGOLOGY, Vol: 42, Pages: 1000-1024, ISSN: 1749-4478
Carter AW, Mandavia R, Mayer E, et al., 2017, Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence., BMJ Open, Vol: 7, ISSN: 2044-6055
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. T
Orlovic M, Carter AW, Marti J, et al., 2017, 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, BMJ Open, Vol: 7, ISSN: 2044-6055
Objective Obstetric care is a high-risk area in healthcaredelivery, so it is essential to have up-to-date quantitativeevidence in this area to inform policy decisions regardingthese services. In light of this, the objective of this studyis to investigate the incidence and economic burden ofthird and fourth-degree lacerations in the English NationalHealth Service (NHS) using recent national data.Methods We used coded inpatient data from HospitalEpisode Statistics (HES) for the financial years from2010/2011 to 2013/2014 for all females that gave birthduring that period in the English NHS. Using HES, we usedpre-existing safety indicator algorithms to calculate theincidence of third and fourth-degree obstetric tears andemployed a propensity score matching method to estimatethe excess length of stay and economic burden associatedwith these events.Results Observed rates per 1000 inpatient episodes in2010/2011 and 2013/2014, respectively: Patient SafetyIndicator—trauma during vaginal delivery with instrument(PSI 18)=84.16 and 91.24; trauma during vaginaldelivery without instrument (PSI 19)=29.78 and 33.43;trauma during caesarean delivery (PSI 20)=3.61 and4.56. Estimated overall (all PSIs) economic burden for2010/2011=£10.7 million and for 2013/2014=£14.5million, expressed in 2013/2014 prices.Conclusions Despite many initiatives targeting thequality of maternity care in the NHS, the incidence of thirdand fourth-degree lacerations has increased during theobserved period which signals that quality improvementefforts in obstetric care may not be reducing incidencerates. Our conservative estimates of the financial burden ofthese events appear low relative to total NHS expenditurefor these years.
Grant Y, St John E, Carter A, et al., 2017, Patient level re-operative costs for oncological margin control following breast conserving surgery, Association of Breast Surgery 2017
Sabharwal S, Carter AW, Rashid A, et al., 2016, Cost analysis of the surgical treatment of fractures of the proximal humerus: an evaluation of the determinants of cost and comparison of the institutional cost of treatment with the national tariff, Bone & Joint Journal, Vol: 98B, Pages: 249-259, ISSN: 2049-4394
Aims The aims of this study were to estimate the cost of surgical treatment of fractures of the proximal humerus using a micro-costing methodology, contrast this cost with the national reimbursement tariff and establish the major determinants of cost.Methods A detailed inpatient treatment pathway was constructed using semi-structured interviews with 32 members of hospital staff. Its content validity was established through a Delphi panel evaluation. Costs were calculated using time-driven activity-based costing (TDABC) and sensitivity analysis was performed to evaluate the determinants of costResults The mean cost of the different surgical treatments was estimated to be £3282. Although this represented a profit of £1138 against the national tariff, hemiarthroplasty as a treatment choice resulted in a net loss of £952. Choice of implant and theatre staffing were the largest cost drivers. Operating theatre delays of more than one hour resulted in a loss of incomeDiscussion Our findings indicate that the national tariff does not accurately represent the cost of treatment for this condition. Effective use of the operating theatre and implant discounting are likely to be more effective cost containment approaches than control of bed-day costs.Take home message: This cost analysis of fractures of the proximal humerus reinforces the limitations of the national tariff within the English National Health Service, and underlines the importance of effective use of the operating theatre, as well as appropriate implant procurement where controlling costs of treatment is concerned.
Naci H, Carter AW, Mossialos E, 2015, Why the drug development pipeline is not delivering better medicines, BMJ-BRITISH MEDICAL JOURNAL, Vol: 351, ISSN: 1756-1833
Despite the large number of new medicines entering the market every year, few offer importantclinical advantages for patients. Huseyin Naci, Alexander Carter, and Elias Mossialos explainthe reasons for this innovation deficit and offer some solutions
Sabharwal S, Carter A, Darzi LA, et al., 2015, The methodological quality of health economic evaluations for the management of hip fractures: A systematic review of the literature, SURGEON-JOURNAL OF THE ROYAL COLLEGES OF SURGEONS OF EDINBURGH AND IRELAND, Vol: 13, Pages: 170-176, ISSN: 1479-666X
Background and objectivesApproximately 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.MethodsA 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).ResultsTwenty-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%).ConclusionsHEEs 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.
Carter AW, Mossialos E, Darzi A, 2015, A national incident reporting and learning system in England and Wales, but at what cost?, EXPERT REVIEW OF PHARMACOECONOMICS & OUTCOMES RESEARCH, Vol: 15, Pages: 365-368, ISSN: 1473-7167
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