Dataset Information

Comparison of the Harms, Advantages, and Costs Associated With Alternative Guidelines for the Evaluation of Hematuria.

ABSTRACT:

Importance

Existing recommendations for the diagnostic testing of hematuria range from uniform evaluation of varying intensity to patient-level risk stratification. Concerns have been raised about not only the costs and advantages of computed tomography (CT) scans but also the potential harms of CT radiation exposure.

Objective

To compare the advantages, harms, and costs associated with 5 guidelines for hematuria evaluation.

Design, setting, and participants

A microsimulation model was developed to assess each of the following guidelines (listed in order of increasing intensity) for initial evaluation of hematuria: Dutch, Canadian Urological Association (CUA), Kaiser Permanente (KP), Hematuria Risk Index (HRI), and American Urological Association (AUA). Participants comprised a hypothetical cohort of patients (n = 100 000) with hematuria aged 35 years or older. This study was conducted from August 2017 through November 2018.

Exposures

Under the Dutch and CUA guidelines, patients received cystoscopy and ultrasonography if they were 50 years or older (Dutch) or 40 years or older (CUA). Under the KP and HRI guidelines, patients received different combinations of cystoscopy, ultrasonography, and CT urography or no evaluation on the basis of risk factors. Under the AUA guidelines, all patients 35 years or older received cystoscopy and CT urography.

Main outcomes and measures

Urinary tract cancer detection rates, radiation-induced secondary cancers (from CT radiation exposure), procedural complications, false-positive rates per 100 000 patients, and incremental cost per additional urinary tract cancer detected.

Results

The simulated cohort included 100 000 patients with hematuria, aged 35 years or older. A total of 3514 patients had urinary tract cancers (estimated prevalence, 3.5%; 95% CI, 3.0%-4.0%). The AUA guidelines missed detection for the fewest number of cancers (82 [2.3%]) compared with the detection rate of the HRI (116 [3.3%]) and KP (130 [3.7%]) guidelines. However, the simulation model projected 108 (95% CI, 34-201) radiation-induced cancers under the KP guidelines, 136 (95% CI, 62-229) under the HRI guidelines, and 575 (95% CI, 184-1069) under the AUA guidelines per 100 000 patients. The CUA and Dutch guidelines missed detection for a larger number of cancers (172 [4.9%] and 251 [7.1%]) but had 0 radiation-induced secondary cancers. The AUA guidelines cost approximately double the other 4 guidelines ($939/person vs $443/person for Dutch guidelines), with an incremental cost of $1 034 374 per urinary tract cancer detected compared with that of the HRI guidelines.

Conclusions and relevance

In this simulation study, uniform CT imaging for patients with hematuria was associated with increased costs and harms of secondary cancers, procedural complications, and false positives, with only a marginal increase in cancer detection. Risk stratification may optimize the balance of advantages, harms, and costs of CT.

SUBMITTER: Georgieva MV

PROVIDER: S-EPMC6664383 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Background and objectivesGlobally, a number of countries have developed guidelines that describe the design and conduct of economic evaluations as part of health technology assessment (HTA) or pharmacoeconomic analysis for decision making. The current scoping review was undertaken with an objective to summarize the recommendations made on methods of economic evaluation by the national healthcare economic evaluation (HEE) guidelines.MethodologyA comprehensive search was undertaken in the website repositories of the International Society for Pharmacoeconomic and Outcomes Research (ISPOR) and Guide to Economic Analysis and Research (GEAR), and websites of national HTA agencies and ministries of health of individual countries. All guidelines in the English language were included in this review. Data were extracted with respect to general and methodological characteristics, and a descriptive analysis of recommendations made across the countries was undertaken.ResultsOverall, our review included 31 national HEE guidelines, published between 1997 and August 2020. Nearly half (45%) of the guidelines targeted the evaluation of pharmaceuticals. The nature of the guidelines was either mandatory (31%), recommendatory (42%), or voluntary (16%). There was a substantial consensus among the guidelines on several key principles, including type of economic evaluation (cost-utility analysis), time horizon of the analysis (long enough), health outcome measure (quality-adjusted life-years) and use of sensitivity analyses. The recommendations on study perspective, comparator, discount rate and type of costs to be included (particularly the inclusion of indirect costs) varied widely.ConclusionDespite similarity in the overall processes, variation in several recommendations given by various national HEE guidelines was observed. This is perhaps unsurprising given the differences in the health systems and financing mechanisms, capacity of local researchers, and data availability. This review offers important lessons and a starting point for countries that are planning to develop their own HEE guidelines.

Project description:OBJECTIVE:The objective of this study was to estimate the population distribution of 10-year cardiovascular disease (CVD) risk among Bangladeshi adults aged 40 years and above, using the 2019 WHO CVD risk prediction charts. Additionally, we compared the cost of CVD pharmacological treatment based on the total CVD risk (thresholds ?30%/?20%) and the single risk factor (hypertension) cut-off levels in the Bangladeshi context. STUDY DESIGN:Cross-sectional, population-based study. SETTING AND PARTICIPANTS:From 2013 to 2014, we collected data from a nationally representative cross-sectional survey of adults aged ?40 years from urban and rural areas of Bangladesh (n=6189). We estimated CVD risk using the 2019 WHO CVD risk prediction charts and categorised as very low (<5%), low (5% to <10%), moderate (10% to <20%), high (20% to <30%) and very high risk (?30%). We estimated drug therapy costs using the lowest price of each drug class available (aspirin, thiazide diuretics, statins and ACE inhibitors). We compared the total cost of drug therapy using the total CVD risk versus single risk factor approach. PRIMARY OUTCOME MEASURES:Our primary outcome was 10-year CVD risk categorised as very low (<5%), low (5% to <10%), moderate (10% to <20%), high (20% to <30%) and very high risk (?30%). RESULTS:The majority of adults (85.2%, 95%?CI 84.3 to 86.1) have a 10-year CVD risk of less than 10%. The proportion of adults with a 10-year CVD risk of ?20% was 0.51%. Only one adult was categorised with a 10-year CVD risk of ?30%. Among adults with CVD risk groups of very low, low and moderate, 17.4%, 27.9% and 41.4% had hypertension (blood pressure (BP) ?140/90) and 0.1%, 1.7% and 2.9% had severe hypertension (BP ?160/100), respectively. Using the total CVD risk approach would reduce drug costs per million populations to US$144?540 (risk of ?20%). CONCLUSION:To reduce healthcare expenditure for the prevention and treatment of CVD, a total risk approach using the 2019 WHO CVD risk prediction charts may lead to cost savings.

Project description:ImportanceAsymptomatic microscopic hematuria (AMH) is highly prevalent and may signal occult genitourinary (GU) malignant abnormality. Common diagnostic approaches differ in their costs and effectiveness in detecting cancer. Given the low prevalence of GU malignant abnormality among patients with AMH, it is important to quantify the cost implications of detecting cancer for each approach.ObjectiveTo estimate the effectiveness, costs, and incremental cost per cancer detected (ICCD) for 4 common diagnostic approaches evaluating AMH.Design, setting, and participantsA decision-analytic model-based cost-effectiveness analysis using inputs from the medical literature. PubMed searches were performed to identify relevant literature for all key model inputs, each of which was derived from the clinical study with the most robust data and greatest applicability. Analysis included adult patients with AMH on routine urinalysis with subgroups of high-risk patients (males, smokers, age ≥50 years) seen in the primary care or urologic referral setting.InterventionsFour diagnostic approaches were evaluated relative to the reference case of no evaluation: (1) computed tomography (CT) alone; (2) cystoscopy alone; (3) CT and cystoscopy combined; and (4) renal ultrasound and cystoscopy combined.Main outcomes and measuresAt termination of the diagnostic period, cancers detected, costs (payer perspective), and ICCD per 10 000 patients evaluated for AMH.ResultsOf the 4 diagnostic approaches analyzed, CT alone was dominated by all other strategies, detecting 221 cancers at a cost of $9 300 000. Ultrasound and cystoscopy detected 245 cancers and was most cost-effective with an ICCD of $53 810. Replacing ultrasound with CT detected just 1 additional cancer at an ICCD of $6 480 484. Ultrasound and cystoscopy remained the most cost-effective approach in subgroup analysis. The model was not sensitive to any inputs within the proposed ranges. Using probabilistic sensitivity analysis, ultrasound and cystoscopy was the dominant strategy in 100% of simulations.Conclusions and relevanceThe combination of renal ultrasound and cystoscopy is the most cost-effective among 4 diagnostic approaches for the initial evaluation of AMH. The use of ultrasound in lieu of CT as the first-line diagnostic strategy will optimize cancer detection and reduce costs associated with evaluation of AMH. Given our findings, we need to critically evaluate the appropriateness of our current clinical practices, and potentially alter our guidelines to reflect the most effective screening strategies for patients with AMH.