The future for diagnostic tests of acute kidney injury in critical care: evidence synthesis, care pathway analysis and research prioritisation

Hall, Peter; Mitchell, Elizabeth; Smith, Alison; Cairns, David A.; Messenger, Michael; Hutchinson, Michelle; Wright, Judy; Vinall‐Collier, Karen; Corps, Claire; Hamilton, Patrick; Meads, David; Lewington, Andrew

doi:10.3310/hta22320

Cited by 32 publications

(80 citation statements)

References 377 publications

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“…The initial search of economic databases identified a total of 2972 records, of which 2157 remained after deduplication. Eight titles 108,110,121,[129][130][131][132][133][134] were identified as potentially relevant based on their titles and/or abstracts. The full-text articles of these records were assessed for eligibility.…”

Section: Resultsmentioning

confidence: 99%

“…The full-text articles of these records were assessed for eligibility. Four studies 108,110,121,129,130 were found to meet the selection criteria and were included in the review. These studies were not subject to a formal assessment, but were used to assist in the overall development of the new analytical model.…”

Section: Resultsmentioning

confidence: 99%

“…Renal replacement therapy was assumed to consist of haemodialysis, based on the study by Kim et al 117 reporting an earlier data cut-off value of Park et al 115 The disutility associated with RRT was sourced from a meta-analysis and a metaregression of utilities in CKD patients 120 that was identified on the reference list of one of the studies (i.e. Hall et al 121 ) examined in the context of the AKI models systematic review. The estimate of -0.11 represents the disutility from dialysis.…”

Section: Acute Kidney Injury Consequences and Overall Mortalitymentioning

confidence: 99%

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Point-of-care creatinine tests to assess kidney function for outpatients requiring contrast-enhanced CT imaging: systematic reviews and economic evaluation

Corbett

Duarte

Llewellyn

et al. 2020

Health Technol Assess

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Background Patients with low estimated glomerular filtration rates may be at higher risk of post-contrast acute kidney injury following contrast-enhanced computed tomography imaging. Point-of-care devices allow rapid measurement of estimated glomerular filtration rates for patients referred without a recent estimated glomerular filtration rate result. Objectives To assess the clinical effectiveness and cost-effectiveness of point-of-care creatinine tests for outpatients without a recent estimated glomerular filtration rate measurement who need contrast-enhanced computed tomography imaging. Methods Three systematic reviews of test accuracy, implementation and clinical outcomes, and economic analyses were carried out. Bibliographic databases were searched from inception to November 2018. Studies comparing the accuracy of point-of-care creatinine tests with laboratory reference tests to assess kidney function in adults in a non-emergency setting and studies reporting implementation and clinical outcomes were included. Risk of bias of diagnostic accuracy studies was assessed using a modified version of the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Probabilities of individuals having their estimated glomerular filtration rates correctly classified were estimated within a Bayesian framework and pooled using a fixed-effects model. A de novo probabilistic decision tree cohort model was developed to characterise the decision problem from an NHS and a Personal Social Services perspective. A range of alternative point-of-care testing approaches were considered. Scenario analyses were conducted. Results Fifty-four studies were included in the clinical reviews. Twelve studies reported diagnostic accuracy for estimated glomerular filtration rates; half were rated as being at low risk of bias, but there were applicability concerns for most. i-STAT (Abbott Point of Care, Inc., Princeton, NJ, USA) and ABL (Radiometer Ltd, Crawley, UK) devices had higher probabilities of correctly classifying individuals in the same estimated glomerular filtration rate categories as the reference laboratory test than StatSensor® devices (Nova Biomedical, Runcorn, UK). There was limited evidence for epoc® (Siemens Healthineers AG, Erlangen, Germany) and Piccolo Xpress® (Abaxis, Inc., Union City, CA, USA) devices and no studies of DRI-CHEM NX 500 (Fujifilm Corporation, Tokyo, Japan). The review of implementation and clinical outcomes included six studies showing practice variation in the management decisions when a point-of-care device indicated an abnormal estimated glomerular filtration rate. The review of cost-effectiveness evidence identified no relevant studies. The de novo decision model that was developed included a total of 14 strategies. Owing to limited data, the model included only i-STAT, ABL800 FLEX and StatSensor. In the base-case analysis, the cost-effective strategy appeared to be a three-step testing sequence involving initially screening all individuals for risk factors, point-of-care testing for those individuals with at least one risk factor, and including a final confirmatory laboratory test for individuals with a point-of-care-positive test result. Within this testing approach, the specific point-of-care device with the highest net benefit was i-STAT, although differences in net benefit with StatSensor were very small. Limitations There was insufficient evidence for patients with estimated glomerular filtration rates < 30 ml/minute/1.73 m2, and on the full potential health impact of delayed or rescheduled computed tomography scans or the use of alternative imaging modalities. Conclusions A three-step testing sequence combining a risk factor questionnaire with a point-of-care test and confirmatory laboratory testing appears to be a cost-effective use of NHS resources compared with current practice. The risk of contrast causing acute kidney injury to patients with an estimated glomerular filtration rate of < 30 ml/minute/1.73 m2 is uncertain. Cost-effectiveness of point-of-care testing appears largely driven by the potential of point-of-care tests to minimise delays within the current computed tomography pathway. Future work Studies evaluating the impact of risk-stratifying questionnaires on workflow outcomes in computed tomography patients without recent estimated glomerular filtration rate results are needed. Study registration This study is registered as PROSPERO CRD42018115818. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 39. See the NIHR Journals Library website for further project information.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Acute Kidney Injury Consequences and Overall Mortalitymentioning

confidence: 99%

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Point-of-care creatinine tests to assess kidney function for outpatients requiring contrast-enhanced CT imaging: systematic reviews and economic evaluation

Corbett

Duarte

Llewellyn

et al. 2020

Health Technol Assess

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“…To evaluate the potential of AKI in-vitro diagnostic tests to improve the management of patients with critical illness, Hall et al performed a systematic review associated with meta-analysis of sensitivity and specificity, cost-effectiveness evaluation, appraisal of analytical validity, care pathway analysis and value of information analysis. They searched various databases (including ClinicalTrials.gov, the Cochrane Library, Embase, Medline, PubMed and Web of Science) to identify relevant sources of information published after 2004 up to July 2015 3. Three tests (TIMP-2●IGFBP7, NGAL (neutrophil gelatinase-associated lipocalin) and cystatin C were subject to detail review.…”

Section: Methodsmentioning

confidence: 99%

Biomarkers of acute kidney injury: mixed results and huge heterogeneity of reporting

Gayat

2019

BMJ EBM

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“…VOI is an increasingly popular tool that can be used to generate information regarding the value of further investment into research, providing information that complements sensitivity analysis (15). Within the early modelling context, VOI can be used to identify key parameters in the model that are driving uncertainty around the expected cost-effectiveness outcomes, and thereby direct the focus and design of future research and development activities (16,17). VOI formed the basis of the recommendations of two projects outlined here (OPTIMA and AKI).…”

Section: Strengthsmentioning

confidence: 99%

Early Economic Evaluation of Diagnostic Technologies: Experiences of the NIHR Diagnostic Evidence Co-operatives

et al. 2019

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Diagnostic tests are expensive and time-consuming to develop. Early economic evaluation using decision modeling can reduce commercial risk by providing early evidence on cost-effectiveness. The National Institute for Health Research Diagnostic Evidence Co-operatives (DECs) was established to catalyze evidence generation for diagnostic tests by collaborating with commercial developers; DEC researchers have consequently made extensive use of early modeling. The aim of this article is to summarize the experiences of the DECs using early modeling for diagnostics. We draw on 8 case studies to illustrate the methods, highlight methodological strengths and weaknesses particular to diagnostics, and provide advice. The case studies covered diagnosis, screening, and treatment stratification. Treatment effectiveness was a crucial determinant of cost-effectiveness in all cases, but robust evidence to inform this parameter was sparse. This risked limiting the usability of the results, although characterization of this uncertainty in turn highlighted the value of further evidence generation. Researchers evaluating early models must be aware of the importance of treatment effect evidence when reviewing the cost-effectiveness of diagnostics. Researchers planning to develop an early model of a test should also 1) consult widely with clinicians to ensure the model reflects real-world patient care; 2) develop comprehensive models that can be updated as the technology develops, rather than taking a “quick and dirty” approach that may risk producing misleading results; and 3) use flexible methods of reviewing evidence and evaluating model results, to fit the needs of multiple decision makers. Decision models can provide vital information for developers at an early stage, although limited evidence mean researchers should proceed with caution.

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The future for diagnostic tests of acute kidney injury in critical care: evidence synthesis, care pathway analysis and research prioritisation

Abstract: The National Institute for Health Research Health Technology Assessment programme.

Cited by 32 publications

References 377 publications

Point-of-care creatinine tests to assess kidney function for outpatients requiring contrast-enhanced CT imaging: systematic reviews and economic evaluation

Point-of-care creatinine tests to assess kidney function for outpatients requiring contrast-enhanced CT imaging: systematic reviews and economic evaluation

Biomarkers of acute kidney injury: mixed results and huge heterogeneity of reporting

Early Economic Evaluation of Diagnostic Technologies: Experiences of the NIHR Diagnostic Evidence Co-operatives

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