Evidence-based recommendations for economic evaluations in spine surgery: study protocol for a Delphi consensus

IntroductionConsidering the rising global healthcare expenses, economic evaluations are more important than ever. Even though the number of studies regarding costs and cost-effectiveness is increasing, the quality of these studies remains relatively low. This is mainly caused by abundant heterogeneity in methods used for determining, calculating and reporting cost data, despite current general guidelines for the conduct of economic evaluations. Disease-specific recommendations for the conduct of economic evaluations in the field of spine surgery, as complement to existing general guidelines, will ameliorate overall research quality, comparability and interpretability and thus, the overall quality. We aim to provide expert-based recommendations for the design, conduct, and reporting of economic evaluations in spine surgery.Methods and analysisA modified Delphi study will be conducted to formulate expert-based recommendations. The following steps will be taken:(1) The conduct of a systematic review to identify relevant publications and identify relevant authors. Formation of an expert group and a Delphi-panel. (2) Drafting of statements based on articles included in the systematic literature review. Validation of drafted statements by the expert group. Step 2 can be repeated up to three times, statements can be discarded and adjusted in these rounds. Statements with more than 75% agreement will be accepted as consensus statements. (3) Validation of statements by the Delphi-panel. (4) Final recommendations.Ethics and disseminationThe underlying work is based on existing literature and published data and does not include participation of patients, and thus does not require ethical review approval. The final recommendations are intended for (clinical) researchers in the field of cost-effectiveness in spine surgery. The Delphi method ensures that the final output reflects the opinions of international participants and gives insight in the adherence level to the recommendations. The aim is to reach uniformity in design, conduct and reporting of these studies, as is currently lacking. This will provide a solid basis to determine cost-effectiveness of spine surgeries and consequently aid to limit the rising healthcare costs. The findings of this study and the final recommendations will be disseminated in conferences and seminars and will be published in an international peer-reviewed journal.

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1209. Expanding an Economic Evaluation of the Veterans Affairs Initiative to Prevent Methicillin-Resistant Staphylococcus aureus Infections to Include Prevention of Gram-Negative Bacteria

Open Forum Infectious Diseases ◽

10.1093/ofid/ofy210.1042 ◽

2018 ◽

Vol 5 (suppl_1) ◽

pp. S366-S367

Author(s):

Richard E Nelson ◽

Michihiko Goto ◽

Matthew Samore ◽

Makoto Jones ◽

Vanessa Stevens ◽

...

Keyword(s):

Cost Effectiveness ◽

Cost Savings ◽

Veterans Affairs ◽

Economic Evaluations ◽

Published Data ◽

Department Of Veterans Affairs ◽

Gram Negative ◽

Trade Offs ◽

Life Years ◽

The Cost

Abstract Background In October 2007, the Department of Veterans Affairs (VA) launched the National MRSA Prevention Initiative, a nationwide effort to reduce MRSA transmission through (1) universal screening, (2) contact isolation for MRSA+ patients, (3) institutional culture change that “infection prevention is everyone’s business,” (4) emphasis on hand hygiene, and (5) increased infection control resources. While the initiative focused on MRSA, recent evidence suggests that it also led to a significant decrease in hospital-onset (HO) Gram-negative rod (GNR) bacteremia. The objective of this analysis was to evaluate the cost-effectiveness and the budget impact of the initiative taking into account both MRSA and GNR infections. Methods We developed an economic model using published data on the rate of MRSA HAIs and HO-GNR bacteremia in the VA from October 2007 to September 2015, estimates of the attributable cost and mortality of these infections, and the costs associated with the intervention obtained through a microcosting approach. We explored several different assumptions for the rate of infections that would have occurred if the initiative had not been implemented. Effectiveness was measured in life-years (LYs) gained. Results We found that during fiscal years 2008–2015, the initiative resulted in an estimated 4,761–9,236 fewer MRSA HAIs and 1,447–2,159 fewer HO-GNR bacteremia. The initiative itself was estimated to cost $206 million over this 8-year period while the cost savings from prevented MRSA HAIs ranged from $75–165 million and from prevented HO-GNR bacteremia ranged from $42–62 million. The incremental cost-effectiveness of the initiative ranged from $12,146–$46,500/LY when just including MRSA HAIs and from $7,945–$24,387/LY when including HO-GNR bacteremia. The overall impact on the VA’s budget ranged from $200–$334 million. Conclusion An MRSA surveillance and prevention strategy in VA may have prevented a substantial number of MRSA and GNR infections. The savings associated with the prevented infections helped to offset some but not all of the cost of the initiative. Economic evaluations of these interventions can help decision makers understand the trade offs between increased cost and improved health that can come from such interventions. Disclosures All authors: No reported disclosures.

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Cost-effectiveness of the long-acting regimen cabotegravir plus rilpivirine for the treatment of HIV-1 and its potential impact on adherence and viral transmission: A modelling study

PLoS ONE ◽

10.1371/journal.pone.0245955 ◽

2021 ◽

Vol 16 (2) ◽

pp. e0245955 ◽

Cited By ~ 1

Author(s):

Ben Parker ◽

Tom Ward ◽

Olivia Hayward ◽

Ian Jacob ◽

Erin Arthurs ◽

...

Keyword(s):

Cost Effectiveness ◽

Lifetime Cost ◽

Phase Iii ◽

Economic Evaluations ◽

Published Data ◽

People Living With Hiv ◽

Directly Observed Therapy ◽

Potential Impact ◽

Long Acting ◽

The Impact

Introduction Combination antiretroviral therapy (cART) improves outcomes for people living with HIV (PLWH) but requires adherence to daily dosing. Suboptimal adherence results in reduced treatment effectiveness, increased costs, and greater risk of resistance and onwards transmission. Treatment with long-acting (LA), injection-based ART administered by healthcare professionals (directly observed therapy (DOT)) eliminates the need for adherence to daily dosing and may improve clinical outcomes. This study reports the cost-effectiveness of the cabotegravir plus rilpivirine LA regimen (CAB+RPV LA) and models the potential impact of LA DOT therapies. Methods Parameterisation was performed using pooled data from recent CAB+RPV LA Phase III trials. The analysis was conducted using a cohort-level hybrid decision-tree and state-transition model, with states defined by viral load and CD4 cell count. The efficacy of oral cART was adjusted to reflect adherence to daily regimens from published data. A Canadian health service perspective was adopted. Results CAB+RPV LA is predicted to be the dominant intervention when compared to oral cART, generating, per 1,000 patients treated, lifetime cost-savings of $1.5 million, QALY and life-year gains of 107 and 138 respectively with three new HIV cases averted. Conclusions Economic evaluations of LA DOTs need to account for the impact of adherence and HIV transmission. This study adds to the existing literature by incorporating transmission and using clinical data from the first LA DOT regimen. Providing PLWH and healthcare providers with novel modes of ART administration, enhancing individualisation of treatment, may facilitate the achievement of UNAIDS 95-95-95 objectives.

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Choice between implants in knee replacement: protocol for a Bayesian network meta-analysis, analysis of joint registries and economic decision model to determine the effectiveness and cost-effectiveness of knee implants for NHS patients—The KNee Implant Prostheses Study (KNIPS)

BMJ Open ◽

10.1136/bmjopen-2020-040205 ◽

2021 ◽

Vol 11 (1) ◽

pp. e040205

Author(s):

Elsa M R Marques ◽

Jane Dennis ◽

Andrew D Beswick ◽

Julian Higgins ◽

Howard Thom ◽

...

Keyword(s):

Cost Effectiveness ◽

Knee Replacement ◽

Systematic Reviews ◽

Ethical Review ◽

Published Data ◽

Economic Modelling ◽

Term Survival ◽

International Orthopaedic ◽

Joint Registry

IntroductionKnee replacements are highly successful for many people, but if a knee replacement fails, revision surgery is generally required. Surgeons and patients may choose from a range of implant components and combinations that make up knee replacement constructs, all with potential implications for how long a knee replacement will last. To inform surgeon and patient decisions, a comprehensive synthesis of data from randomised controlled trials is needed to evaluate the effects of different knee replacement implants on overall construct survival. Due to limited follow-up in trials, joint registry analyses are also needed to assess the long-term survival of constructs. Finally, economic modelling can identify cost-effective knee replacement constructs for different patient groups.Methods and analysisIn this protocol, we describe systematic reviews and network meta-analyses to synthesise evidence on the effectiveness of knee replacement constructs used in total and unicompartmental knee replacement and analyses of two national joint registries to assess long-term outcomes. Knee replacement constructs are defined by bearing materials and mobility, constraint, fixation and patella resurfacing. For men and women in different age groups, we will compare the lifetime cost-effectiveness of knee replacement constructs.Ethics and disseminationSystematic reviews are secondary analyses of published data with no ethical approval required. We will design a common joint registry analysis plan and provide registry representatives with information for submission to research or ethics committees. The project has been assessed by the National Health Service (NHS) REC committee and does not require ethical review.Study findings will be disseminated to clinicians, researchers and administrators through open access articles, presentations and websites. Specific UK-based groups will be informed of results including National Institute for Health Research and National Institute for Health and Care Excellence, as well as international orthopaedic associations and charities. Effective dissemination to patients will be guided by our patient–public involvement group and include written lay summaries and infographics.PROSPERO registration numberCRD42019134059 and CRD42019138015.

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An Expert Delphi study to derive a tool for mental health triage in emergency departments

Emergency Medicine Journal ◽

10.1136/emermed-2018-208388 ◽

2019 ◽

pp. emermed-2018-208388 ◽

Cited By ~ 1

Author(s):

Anna J Mackway-Jones ◽

Kevin C Mackway-Jones

Keyword(s):

Mental Health ◽

Delphi Study ◽

Mental Health Problems ◽

Delphi Panel ◽

Mental Health Crisis ◽

Physical And Mental Health ◽

Health Crisis ◽

Consensus Statements ◽

Self Harm ◽

Harm To Others

ObjectiveThis study aimed to investigate and collate the opinions of experts regarding the triage of patients in mental health crisis presenting to EDs.DesignA three-round e-Delphi study was conducted between November 2017 and April 2018. The panel of 28 representative experts were drawn from six stakeholder groups. 23 of the panel were clinicians working in England, while 5 were international triage experts.ResultsExperts generated 173 statements in six topic areas in the first round. 32 of these statements reached consensus in round 2. A further 20 statements reached consensus in round 3, leaving 121 statements that did not reach consensus. The consensus statements were used to develop a structured five-level triage tool where the highest level of priority was assigned to patients exhibiting extreme aggression or agitation, those requiring restraint, those at immediate risk of leaving before assessment and those who presented a high risk of self-harm or harm to others. At lower triage priorities, other factors, such as items of psychiatric history, collateral history, observations and judgements, have been identified.ConclusionsA broadly based, multispecialty, multiprofessional expert Delphi panel has reached consensus on 52 statements concerning the triage of patients presenting in mental health crisis to EDs. The triage tool derived from this work can be used to inform the design of triage instruments employed to prioritise patients with physical and mental health problems equitably.

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Designing for Dissemination in Chronic Disease Prevention and Management

10.1093/oso/9780190683214.003.0007 ◽

2017 ◽

Cited By ~ 1

Author(s):

Neville Owen ◽

Ana Goode ◽

Takemi Sugiyama ◽

Mohammad Javad Koohsari ◽

Genevieve Healy ◽

...

Keyword(s):

Physical Activity ◽

Chronic Disease ◽

Cost Effectiveness ◽

Health Behavior Change ◽

The Other ◽

Research Quality ◽

Policy Initiatives ◽

Rigorous Study ◽

Behavior Change Program

This chapter emphasizes the need for research that is designed and implemented explicitly with dissemination in mind. This is illustrated in relation to environmental and policy initiatives to influence physical activity through active transport, and through the example of initiatives to reduce workplace sitting. The other element of this chapter, the broad-reach intervention-dissemination case study of a health behavior-change program, highlights the need to maintain key elements of research quality in designing for dissemination, to the extent that is practically possible: a rigorous study design; the systematic tracking of implementation and related costs; and, the conduct of dose-response, maintenance and cost-effectiveness analyses. These examples of designing for dissemination illustrate not only the exciting opportunities for real-world dissemination research, but also the resourcefulness and commitment required for success.

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Value assessment of antimicrobials and the implications for development, access, and funding of effective treatments: Australian stakeholder perspective

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462320000823 ◽

2020 ◽

pp. 1-7

Author(s):

Nadine T. Hillock ◽

Tracy L. Merlin ◽

Jonathan Karnon ◽

John Turnidge ◽

Jaklin Eliott

Keyword(s):

Cost Effectiveness ◽

Healthcare Resource ◽

Economic Evaluations ◽

Value Assessment ◽

Antimicrobial Drugs ◽

Policy Makers ◽

Stakeholder Perspective ◽

Definition Of ◽

The Impact ◽

Potential Use

Abstract Background The frameworks used by Health Technology Assessment (HTA) agencies for value assessment of medicines aim to optimize healthcare resource allocation. However, they may not be effective at capturing the value of antimicrobial drugs. Objectives To analyze stakeholder perceptions regarding how antimicrobials are assessed for value for reimbursement purposes and how the Australian HTA framework accommodates the unique attributes of antimicrobials in cost-effectiveness evaluation. Methods Eighteen individuals representing the pharmaceutical industry or policy-makers were interviewed. Interviews were transcribed verbatim, coded, and thematically analyzed. Results Key emergent themes were that reimbursement decision-making should consider the antibiotic spectrum when assessing value, risk of shortages, the impact of procurement processes on low-priced comparators, and the need for methodological transparency when antimicrobials are incorporated into the economic evaluation of other treatments. Conclusions Participants agreed that the current HTA framework for antimicrobial value assessment is inadequate to properly inform funding decisions, as the contemporary definition of cost-effectiveness fails to explicitly incorporate the risk of future resistance. Policy-makers were uncertain about how to incorporate future resistance into economic evaluations without a systematic method to capture costs avoided due to good stewardship. Lacking financial reward for the benefits of narrower-spectrum antimicrobials, companies will likely focus on developing broad-spectrum agents with wider potential use. The perceived risks of shortages have influenced the funding of generic antimicrobials in Australia, with policy-makers suggesting a willingness to pay more for assured supply. Although antibiotics often underpin the effectiveness of other medicines, it is unclear how this is incorporated into economic models.

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European List of Essential Medicines for Medical Education: a protocol for a modified Delphi study

BMJ Open ◽

10.1136/bmjopen-2020-045635 ◽

2021 ◽

Vol 11 (5) ◽

pp. e045635

Author(s):

Erik Donker ◽

David Brinkman ◽

Milan Richir ◽

Paraskevi Papaioannidou ◽

Robert Likic ◽

...

Keyword(s):

Medical Education ◽

Delphi Study ◽

Medical Training ◽

Medical Center ◽

European Countries ◽

Essential Medicines ◽

Ethical Review ◽

Junior Doctors ◽

Direct Supervision ◽

Modified Delphi

IntroductionJunior doctors are responsible for a substantial number of prescribing errors, and final-year medical students lack sufficient prescribing knowledge and skills just before they graduate. Various national and international projects have been initiated to reform the teaching of clinical pharmacology and therapeutics (CP&T) during undergraduate medical training. However, there is as yet no list of commonly prescribed and available medicines that European doctors should be able to independently prescribe safely and effectively without direct supervision. Such a list could form the basis for a European Prescribing Exam and would harmonise European CP&T education. Therefore, the aim of this study is to reach consensus on a list of widely prescribed medicines, available in most European countries, that European junior doctors should be able to independently prescribe safely and effectively without direct supervision: the European List of Essential Medicines for Medical Education.Methods and analysisThis modified Delphi study will recruit European CP&T teachers (expert group). Two Delphi rounds will be carried out to enable a list to be drawn up of medicines that are available in ≥80% of European countries, which are considered standard prescribing practice, and which junior doctors should be able to prescribe safely and effectively without supervision.Ethics and disseminationThe study has been approved by the Medical Ethics Review Committee of VU University Medical Center (no. 2020.335) and by the Ethical Review Board of the Netherlands Association for Medical Education (approved project no. NVMO‐ERB 2020.4.8). The European List of Essential Medicines for Medical Education will be presented at national and international conferences and will be submitted to international peer-reviewed journals. It will also be used to develop and implement the European Prescribing Exam.

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Time-to-event analysis in economic evaluations: a comparison of modelling methods to assess the cost-effectiveness of transplanting a marginal quality kidney

Health Economics Review ◽

10.1186/s13561-021-00312-4 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Sameera Senanayake ◽

Nicholas Graves ◽

Helen Healy ◽

Keshwar Baboolal ◽

Adrian Barnett ◽

...

Keyword(s):

Cost Effectiveness ◽

Time Horizon ◽

Transition Probabilities ◽

Discrete Event ◽

Economic Evaluations ◽

Event Analysis ◽

Time To Event ◽

Modelling Method ◽

Cycle Lengths ◽

Modelling Methods

Abstract Background Economic-evaluations using decision analytic models such as Markov-models (MM), and discrete-event-simulations (DES) are high value adds in allocating resources. The choice of modelling method is critical because an inappropriate model yields results that could lead to flawed decision making. The aim of this study was to compare cost-effectiveness when MM and DES were used to model results of transplanting a lower-quality kidney versus remaining waitlisted for a kidney. Methods Cost-effectiveness was assessed using MM and DES. We used parametric survival models to estimate the time-dependent transition probabilities of MM and distribution of time-to-event in DES. MMs were simulated in 12 and 6 monthly cycles, out to five and 20-year time horizon. Results DES model output had a close fit to the actual data. Irrespective of the modelling method, the cycle length of MM or the time horizon, transplanting a low-quality kidney as compared to remaining waitlisted was the dominant strategy. However, there were discrepancies in costs, effectiveness and net monetary benefit (NMB) among different modelling methods. The incremental NMB of the MM in the 6-months cycle lengths was a closer fit to the incremental NMB of the DES. The gap in the fit of the two cycle lengths to DES output reduced as the time horizon increased. Conclusion Different modelling methods were unlikely to influence the decision to accept a lower quality kidney transplant or remain waitlisted on dialysis. Both models produced similar results when time-dependant transition probabilities are used, most notable with shorter cycle lengths and longer time-horizons.

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Costs and Cost-Effectiveness of User-Testing of Health Professionals’ Guidelines to Reduce the Frequency of Intravenous Medicines Administration Errors by Nurses in the United Kingdom: A Probabilistic Model Based on Voriconazole Administration

Applied Health Economics and Health Policy ◽

10.1007/s40258-021-00675-z ◽

2021 ◽

Author(s):

Matthew D. Jones ◽

Bryony Dean Franklin ◽

D. K. Raynor ◽

Howard Thom ◽

Margaret C. Watson ◽

...

Keyword(s):

Cost Effectiveness ◽

Medication Error ◽

Low Cost ◽

Cost Savings ◽

Credible Interval ◽

Probability Of Detection ◽

Sensitivity Analyses ◽

Decision Analytic Model ◽

Published Data ◽

User Testing

Abstract Aim In the UK, injectable medicines are often prepared and administered by nurses following the Injectable Medicines Guide (IMG). Our earlier study confirmed a higher frequency of correct administration with user-tested versus standard IMG guidelines. This current study aimed to model the cost-effectiveness of user-testing. Methods The costs and cost-effectiveness of user-testing were explored by modifying an existing probabilistic decision-analytic model. The adapted model considered administration of intravenous voriconazole to hospital inpatients by nurses. It included 11 error types, their probability of detection and level of harm. Model inputs (including costs) were derived from our previous study and other published data. Monte Carlo simulation using 20,000 samples (sufficient for convergence) was performed with a 5-year time horizon from the perspective of the 121 NHS trusts and health boards that use the IMG. Sensitivity analyses were undertaken for the risk of a medication error and other sources of uncertainty. Results The net monetary benefit at £20,000/quality-adjusted life year was £3,190,064 (95% credible interval (CrI): −346,709 to 8,480,665), favouring user-testing with a 96% chance of cost-effectiveness. Incremental cost-savings were £240,943 (95% CrI 43,527–491,576), also favouring user-tested guidelines with a 99% chance of cost-saving. The total user testing cost was £6317 (95% CrI 6012–6627). These findings were robust to assumptions about a range of input parameters, but greater uncertainty was seen with a lower medication error risk. Conclusions User-testing of injectable medicines guidelines is a low-cost intervention that is highly likely to be cost-effective, especially for high-risk medicines.

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