scholarly journals Pharmacogenetic testing for adverse drug reaction prevention: systematic review of economic evaluations and the appraisal of quality matters for clinical practice and implementation

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Saowalak Turongkaravee ◽  
Jiraphun Jittikoon ◽  
Onwipa Rochanathimoke ◽  
Kathleen Boyd ◽  
Olivia Wu ◽  
...  

Abstract Background Genetic testing has potential roles in identifying whether an individual would have risk of adverse drug reactions (ADRs) from a particular medicine. Robust cost-effectiveness results on genetic testing would be useful for clinical practice and policy decision-making on allocating resources effectively. This study aimed to update a systematic review on economic evaluations of pharmacogenetic testing to prevent ADRs and critically appraise the quality of reporting and sources of evidence for model input parameters. Methods We searched studies through Medline via PubMed, Scopus and CRD’s NHS Economic Evaluation up to October 2019. Studies investigating polymorphism-based pharmacogenetic testing, which guided drug therapies to prevent ADRs, using economic evaluation methods were included. Two reviewers independently performed data extraction and assessed the quality of reporting using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) guidelines and the quality of data sources using the hierarchy of evidence developed by Cooper et al. Results Fifty-nine economic evaluations of pharmacogenetic testing to avoid drug-induced ADRs were found between 2002 and 2018. Cost-utility and cost-effectiveness analyses were the most common methods of economic evaluation of pharmacogenetic testing. Most studies complied with the CHEERS checklist, except for single study-based economic evaluations which did not report uncertainty analysis (78%). There was a lack of high-quality evidence not only for estimating the clinical effectiveness of pharmacogenetic testing, but also baseline clinical data. About 14% of the studies obtained clinical effectiveness data of testing from a meta-analysis of case-control studies with direct comparison, which was not listed in the hierarchy of evidence used. Conclusions Our review suggested that future single study-based economic evaluations of pharmacogenetic testing should report uncertainty analysis, as this could significantly affect the robustness of economic evaluation results. A specific ranking system for the quality of evidence is needed for the economic evaluation of pharmacogenetic testing of ADRs. Differences in parameters, methods and outcomes across studies, as well as population-level and system-level differences, may lead to the difficulty of comparing cost-effectiveness results across countries.

2020 ◽  
Vol 36 (4) ◽  
pp. 380-387
Author(s):  
Sarah Fontenay ◽  
Lionel Catarino ◽  
Soumeya Snoussi ◽  
Hélène van den Brink ◽  
Judith Pineau ◽  
...  

ObjectiveBecause of a lack of suitable heart donors, alternatives to transplantation are required. These alternatives can have high costs. The aim of this study was to perform a systematic review of cost-effectiveness studies of ventricular assist devices (VADs) and to assess the level of evidence of relevant studies. The purpose was not to present economic findings.MethodsA systematic review was performed using four electronic databases to identify health economic evaluation studies dealing with VADs. The methodological quality and reporting quality of the studies was assessed using three different tools, the Drummond, Cooper, and CHEERS (Consolidated Health Economic Evaluation Reporting Standards) checklists.ResultsOf the 1,258 publications identified, thirteen articles were included in this review. Twelve studies were cost–utility analyses and one was a cost-effectiveness analysis. According to the Cooper hierarchy scale, the quality of the data used was heterogeneous. The level of evidence used for clinical effect sizes, safety data, and baseline clinical data was of poor quality. In contrast, cost data were of high quality in most studies. Quality of reporting varied between studies, with an average score of 17.4 (range 15–19) according to the CHEERS checklist.ConclusionThe current study shows that the quality of clinical data used in economic evaluations of VADs is rather poor in general. This is a concern that deserves greater attention in the process of health technology assessment of medical devices.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Olanrewaju Medu ◽  
Adegboyega Lawal ◽  
Doug Coyle ◽  
Kevin Pottie

Abstract Introduction This study reviewed the economic evidence of rapid HIV testing versus conventional HIV testing in low-prevalence high-income countries; evaluated the methodological quality of existing economic evaluations of HIV testing studies; and made recommendations on future economic evaluation directions of HIV testing approaches. Methods A systematic search of selected databases for relevant English language studies published between Jan 1, 2001, and Jan 30, 2019, was conducted. The methodological design quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) and the Drummond tool. We reported the systematic review according to the PRISMA guidelines. Results Five economic evaluations met the eligibility criteria but varied in comparators, evaluation type, perspective, and design. The methodologic quality of the included studies ranged from medium to high. We found evidence to support the cost-effectiveness of rapid HIV testing approaches in low-prevalence high-income countries. Rapid HIV testing was associated with cost per adjusted life year (QALY), ranging from $42,768 to $90,498. Additionally, regardless of HIV prevalence, rapid HIV testing approaches were the most cost-effective option. Conclusions There is evidence for the cost-effectiveness of rapid HIV testing, including the use of saliva-based testing compared to usual care or hospital-based serum testing. Further studies are needed to draw evidence on the relative cost-effectiveness of the distinct options and contexts of rapid HIV testing.


2005 ◽  
Vol 21 (4) ◽  
pp. 423-432 ◽  
Author(s):  
Gerry Richardson ◽  
Hugh Gravelle ◽  
Helen Weatherly ◽  
Gill Ritchie

Objectives: Interventions to support patient self-care of their condition aim to improve patient health and reduce health service costs. Consequently, they have attracted considerable policy interest. There is some evidence of clinical effectiveness but less attention has been paid to whether these interventions are cost-effective. This study examines the quality and quantity of existing evidence of the cost-effectiveness.Methods: A systematic review was carried out to assess the extent and quality of economic evaluations of self-care support interventions. Thirty-nine economic evaluations were assessed against a quality checklist developed to reflect the special features of these interventions.Results: The majority of the studies claimed that self-care support interventions were cost-effective or cost saving. The overall quality of economic evaluations was poor because of flaws in study designs, especially a narrow definition of relevant costs and short follow-up periods.Conclusions: The current evidence base does not support any general conclusion that self-care support interventions are cost-effective, but ongoing trials may provide clearer evidence.


2017 ◽  
Vol 33 (4) ◽  
pp. 454-462 ◽  
Author(s):  
Lidia García-Pérez ◽  
Renata Linertová ◽  
Alejandro Arvelo-Martín ◽  
Carolina Guerra-Marrero ◽  
Carlos Enrique Martínez-Alberto ◽  
...  

Objectives:The methodological quality of an economic evaluation performed alongside a clinical trial can be underestimated if the paper does not report key methodological features. This study discusses methodological assessment issues on the example of a systematic review on cost-effectiveness of physiotherapy for knee osteoarthritis.Methods:Six economic evaluation studies included in the systematic review and related clinical trials were assessed using the 10-question check-list by Drummond and the Physiotherapy Evidence Database (PEDro) scale.Results:All economic evaluations were performed alongside a clinical trial but the studied interventions were too heterogeneous to be synthesized. Methodological quality of the economic evaluations reported in the papers was not free of drawbacks, and in some cases, it improved when information from the related clinical trial was taken into account.Conclusions:Economic evaluation papers dedicate little space to methodological features of related clinical trials; therefore, the methodological quality can be underestimated if evaluated separately from the trials. Future economic evaluations should follow more strictly the recommendations about methodology and the authors should pay special attention to the quality of reporting.


BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e027490 ◽  
Author(s):  
Giulia Rinaldi ◽  
Alexa Hijazi ◽  
Hassan Haghparast-Bidgoli

IntroductionType 2 diabetes mellitus (T2DM) remains one of the most common chronic diseases of adulthood which creates high degrees of morbidity and mortality worldwide. The incidence of T2DM continues to rise and recently, mHealth interventions have been increasingly used in the prevention, monitoring and management of T2DM. The aim of this study is to systematically review the published evidence on cost and cost-effectiveness of mHealth interventions for T2DM, as well as assess the quality of reporting of the evidence.Methods and analysisA comprehensive review of PubMed, EMBASE, Science Direct and Web of Science of articles published until January 2019 will be conducted. Included studies will be partial or full economic evaluations which provide cost or cost-effectiveness results for mHealth interventions targeting individuals diagnosed with, or at risk of, T2DM. The quality of reporting evidence will be assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Results will be presented using a flowchart following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. Graphical and tabulated representations of the results will be created for both descriptive and numerical results. The cost and cost-effectiveness values will be presented as reported by the original studies as well as converted into international dollars to allow comparability. As we are predicting heterogenous results, we will conduct a narrative and interpretive analysis of the data.Ethics and disseminationNo formal approval or review of ethics is required for this systematic review as it will involve the collection and analysis of secondary data. This protocol follows the current PRISMA-P guidelines. The review will provide information on the cost and cost-effectiveness of mHealth interventions targeting T2DM. These results will be disseminated through publication and submission to conferences for presentations and posters.PROSPERO registration numberCRD42019123476


BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e057171
Author(s):  
Nikki McCaffrey ◽  
Julie Higgins ◽  
Anita Lal

IntroductionThe short-term economic benefit of embedding best practice tobacco dependence treatment (TDT) into healthcare services prior to surgery across different populations and jurisdictions is largely unknown. The aim of this systematic review is to summarise the cost-effectiveness of preoperative smoking cessation interventions for preventing surgical complications compared with usual care. The results will provide hospital managers, clinicians, healthcare professionals and policymakers with a critical summary of the economic evidence on providing TDT routinely before surgery, aiding the development and dissemination of unified, best practice guidelines, that is, implementation of article 14 of the WHO Framework Convention on Tobacco Control.Methods and analysisA comprehensive search of peer-reviewed literature will be conducted from database inception until 23 June 2021 (Cochrane, Econlit, Embase, Health Technology Assessment, Medline Complete, Scopus). Published, English-language articles describing economic evaluations of preoperative smoking cessation interventions for preventing surgical complications will be included. One researcher will complete the searches and two researchers will independently screen results for eligible studies. Any disagreement will be resolved by the third researcher. A narrative summary of included studies will be provided. Study characteristics, economic evaluation methods and cost-effectiveness results will be extracted by one reviewer and descriptive analyses will be undertaken. A second reviewer will review data extracted for accuracy from 10% of the included studies. Reporting and methodological quality of the included studies will be evaluated independently by two reviewers using the Consolidated Health Economic Evaluation Reporting Standards statement and the Quality of Health Economic Studies Instrument checklist, respectively.Ethics and disseminationThis research does not require ethics approval because the study is a planned systematic review of published literature. Findings will be presented at health economic, public health and tobacco control conferences, published in a peer-reviewed journal and disseminated via social media.Trial registration numberCRD42021257740.


BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e048141
Author(s):  
Sara Mucherino ◽  
Valentina Lorenzoni ◽  
Valentina Orlando ◽  
Isotta Triulzi ◽  
Marzia Del Re ◽  
...  

IntroductionThe combination of biomarkers and drugs is the subject of growing interest both from regulators, physicians and companies. This study protocol of a systematic review is aimed to describe available literature evidences about the cost-effectiveness, cost-utility or net-monetary benefit of the use of biomarkers in solid tumour as tools for customising immunotherapy to identify what further research needs.Methods and analysisA systematic review of the literature will be carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. PubMed and Embase will be queried from June 2010 to June 2021. The PICOS model will be applied: target population (P) will be patients with solid tumours treated with immune checkpoint inhibitors (ICIs); the interventions (I) will be test of the immune checkpoint predictive biomarkers; the comparator (C) will be any other targeted or non-targeted therapy; outcomes (O) evaluated will be health economic and clinical implications assessed in terms of incremental cost-effectiveness ratio, net health benefit, net monetary benefit, life years gained, quality of life, etc; study (S) considered will be economic evaluations reporting cost-effectiveness analysis, cost-utility analysis, net-monetary benefit. The quality of the evidence will be graded according to Grading of Recommendations Assessment, Development and Evaluation.Ethics and disseminationThis systematic review will assess the cost-effectiveness implications of using biomarkers in the immunotherapy with ICIs, which may help to understand whether this approach is widespread in real clinical practice. This research is exempt from ethics approval because the work is carried out on published documents. We will disseminate this protocol in a related peer-reviewed journal.PROSPERO registration numberCRD42020201549.


PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0245963
Author(s):  
Inge J. M. H. Caelers ◽  
Suzanne L. de Kunder ◽  
Kim Rijkers ◽  
Wouter L. W. van Hemert ◽  
Rob A. de Bie ◽  
...  

Introduction The demand for spinal fusion surgery has increased over the last decades. Health care providers should take costs and cost-effectiveness of these surgeries into account. Open transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) are two widely used techniques for spinal fusion. Earlier research revealed that TLIF is associated with less blood loss, shorter surgical time and sometimes shorter length of hospital stay, while effectiveness of both techniques on back and/or leg pain are equal. Therefore, TLIF could result in lower costs and be more cost-effective than PLIF. This is the first systematic review comparing direct and indirect (partial) economic evaluations of TLIF with PLIF in adults with lumbar spondylolisthesis. Furthermore, methodological quality of included studies was assessed. Methods Searches were conducted in eight databases for reporting on eligibility criteria; TLIF or PLIF, lumbar spondylolisthesis or lumbar instability, and cost. Costs were converted to United States Dollars with reference year 2020. Study quality was assessed using the bias assessment tool of the Cochrane Handbook for Systematic Reviews of Interventions, the Level of Evidence guidelines of the Oxford Centre for Evidence-based Medicine and the Consensus Health Economic Criteria (CHEC) list. Results Of a total of 693 studies, 16 studies were included. Comparison of TLIF and PLIF could only be made indirectly, since no study compared TLIF and PLIF directly. There was a large heterogeneity in health care and societal perspective costs due to different in-, and exclusion criteria, baseline characteristics and the use of costs or charges in calculations. Health care perspective costs, calculated with hospital costs, ranged from $15,867-$43,217 in TLIF-studies and $32,662 in one PLIF-study. Calculated with hospital charges, it ranged from $8,964-$51,469 in TLIF-studies and $21,838-$93,609 in two PLIF-studies. Societal perspective costs and cost-effectiveness, only mentioned in TLIF-studies, ranged from $5,702/QALY-$48,538/QALY and $50,092/QALY-$90,977/QALY, respectively. Overall quality of studies was low. Conclusions This systematic review shows that TLIF and PLIF are expensive techniques. Moreover, firm conclusions about the preferable technique, based on (partial) economic evaluations, cannot be drawn due to limited studies and heterogeneity. Randomized prospective trials and full economical evaluations with direct TLIF and PLIF comparison are needed to obtain high levels of evidence. Furthermore, development of guidelines to perform adequate economic evaluations, specified for the field of interest, will be useful to minimize heterogeneity and maximize transferability of results. Trial registration Prospero-database registration number: CRD42020196869.


2021 ◽  
Author(s):  
Sergio Marin ◽  
Mateu Serra-Prat ◽  
Omar Ortega ◽  
Pere Clavé

Abstract Background and purpose: Oropharyngeal Dysphagia (OD) affects 40-81% of patients after stroke. A recent systematic review on the costs of OD and it’s main complications showed higher acute and long-term costs for those patients who developed OD, malnutrition and pneumonia after stroke. These results suggest that appropriate management of post-stroke OD could lead to reduction of clinical complications and significant cost savings. The purpose of this systematic review is to assess the available literature exploring the efficiency or cost-effectiveness of available healthcare interventions on the appropriate management of OD. Methods: A systematic review on economic evaluations of health care interventions on post-stroke patients with OD following PRISMA recommendations will be performed. MEDLINE, Embase, the National Health Service Economic Evaluation Database and the Cost-Effectiveness Analysis Registry Database will be searched and a subsequent reference check will be done. English and Spanish literature will be included without date restrictions. Studies will be included if they refer to economic evaluations or studies in which cost savings were reported in post-stroke patients suffering OD. Studies will be excluded if they are partial economic evaluation studies, if they refer to esophageal dysphagia, or if OD is caused by causes different from stroke. Evidence will be presented and synthetized with a narrative method and using tables. Quality evaluation will be done using Consolidated Health Economic Evaluation Reporting Standards (CHEERS) Statement. Discussion: The protocol for this systematic review is the first step to assess the cost-effectiveness of the healthcare interventions that have been described as potential treatments for post-stroke OD. This systematic review will summarize the current evidence on the relation between cost and benefits associated with the appropriate management of OD in post-stroke patients. Systematic review registration: PROSPERO CRD42020136245


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