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A cost analysis of intensified vs conventional multifactorial therapy in individuals with type 2 diabetes: a post hoc analysis of the Steno-2 study.

ABSTRACT: AIMS/HYPOTHESIS:Long-term follow-up of the Steno-2 study demonstrated that intensified multifactorial intervention increased median lifespan by 7.9 years and delayed incident cardiovascular disease by a median of 8.1 years compared with conventional multifactorial intervention during 21.2 years of follow-up. In this post hoc analysis of data from the Steno-2 study, we aimed to study the difference in direct medical costs associated with conventional vs intensified treatment. METHODS:In 1993, 160 Danish individuals with type 2 diabetes and microalbuminuria were randomised to conventional or intensified multifactorial target-driven intervention for 7.8 years. Information on direct healthcare costs was retrieved from health registries, and the costs in the two groups of participants were compared by bootstrap t test analysis. RESULTS:Over 21.2 years of follow-up, there was no difference in total direct medical costs between the intensified treatment group, €12,126,900, and the conventional treatment group, €11,181,700 (p?=?0.48). The mean cost per person-year during 1996-2014 was significantly lower in the intensified treatment group (€8725 in the intensive group and €10,091 in the conventional group, p?=?0.045). The main driver of this difference was reduced costs associated with inpatient admissions related to cardiovascular disease (p?=?0.0024). CONCLUSIONS/INTERPRETATION:Over a follow-up period of 21.2 years, we found no difference in total costs and reduced cost per person-year associated with intensified multifactorial treatment for 7.8 years compared with conventional multifactorial treatment. Considering the substantial gain in life-years and health benefits achieved with intensified treatment, we conclude that intensified multifaceted intervention in high-risk individuals with type 2 diabetes seems to be highly feasible when balancing healthcare costs and treatment benefits in a Danish healthcare setting.

SUBMITTER: Gæde J

PROVIDER: S-EPMC6290682 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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A cost analysis of intensified vs conventional multifactorial therapy in individuals with type 2 diabetes: a post hoc analysis of the Steno-2 study.

Gæde Joachim J Oellgaard Jens J Ibsen Rikke R Gæde Peter P Nørtoft Emil E Parving Hans-Henrik HH Kjellberg Jakob J Pedersen Oluf O

Diabetologia 20181006 1

<h4>Aims/hypothesis</h4>Long-term follow-up of the Steno-2 study demonstrated that intensified multifactorial intervention increased median lifespan by 7.9 years and delayed incident cardiovascular disease by a median of 8.1 years compared with conventional multifactorial intervention during 21.2 years of follow-up. In this post hoc analysis of data from the Steno-2 study, we aimed to study the difference in direct medical costs associated with conventional vs intensified treatment.<h4>Methods</ ...[more]

PMID: 30293113

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Project description:AIMS/HYPOTHESIS:In type 2 diabetes mellitus, heart failure is a frequent, potentially fatal and often forgotten complication. Glucose-lowering agents and adjuvant therapies modify the risk of heart failure. We recently reported that 7.8 years of intensified compared with conventional multifactorial intervention in individuals with type 2 diabetes and microalbuminuria in the Steno-2 study reduced the risk of cardiovascular disease and prolonged life over 21.2 years of follow-up. In this post hoc analysis, we examine the impact of intensified multifactorial intervention on the risk of hospitalisation for heart failure. METHODS:One hundred and sixty individuals were randomised to conventional or intensified multifactorial intervention, using sealed envelopes. The trial was conducted using the Prospective, Randomised, Open, Blinded Endpoints (PROBE) design. After 7.8 years, all individuals were offered intensified therapy and the study continued as an observational follow-up study for an additional 13.4 years. Heart-failure hospitalisations were adjudicated from patient records by an external expert committee blinded for treatment allocation. Event rates were compared using a Cox regression model adjusted for age and sex. RESULTS:Eighty patients were assigned to each treatment group. Ten patients undergoing intensive therapy vs 24 undergoing conventional therapy were hospitalised for heart failure during follow-up. The HR (95% CI) was 0.30 (0.14, 0.64), p?=?0.002 in the intensive-therapy group compared with the conventional-therapy group. Including death in the endpoint did not lead to an alternate overall outcome; HR 0.51 (0.34, 0.76), p?=?0.001. In a pooled cohort analysis, an increase in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) during the first two years of the trial was associated with incident heart failure. CONCLUSIONS/INTERPRETATION:Intensified, multifactorial intervention for 7.8 years in type 2 diabetic individuals with microalbuminuria reduced the risk of hospitalisation for heart failure by 70% during a total of 21.2 years of observation. TRIAL REGISTRATION:ClinicalTrials.gov NCT00320008.

Project description:BackgroundConventional CTCS images the mid/lower chest for coronary artery disease (CAD). Because many CAD patients are also at risk for lung malignancy, CTCS often discovers incidental pulmonary nodules (IPN). CTCS excludes the upper chest, where malignancy is common. Full-chest CTCS (FCT) may be a cost-effective screening tool for IPN.MethodsA decision tree was created to compare a FCT to CTCS in a hypothetical patient cohort with suspected CAD. (Figure) The design compares the effects of missed cancers on CTCS with the cost of working up non-malignant nodules on FCT. The model was informed by results of the National Lung Screening Trial and literature review, including the rate of malignancy among patients receiving CTCS and the rate of malignancy in upper vs lower portions of the lung. The analysis outcomes are Quality-Adjusted Life Year (QALY) and incremental cost-effectiveness ratio (ICER), which is generally considered beneficial when <$50,000/QALY.ResultsLiterature review suggests that rate of IPNs in the upper portion of the lung varied from 47 to 76%. Our model assumed that IPNs occur in upper and lower portions of the lung with equal frequency. The model also assumes an equal malignancy potential in upper lung IPNs despite data that malignancy occurs 61–66% in upper lung fields.In the base case analysis, a FCT will lead to an increase of 0.03 QALYs comparing to conventional CTCS (14.54 vs 14.51 QALY, respectively), which translates into an QALY increase of 16?days. The associated incremental cost for FCT is $278 ($1027 vs $748, FCT vs CTCS respectively. The incremental cost-effectiveness ratio (ICER) is $10,289/QALY, suggesting significant benefit. Sensitivity analysis shows this benefit increases proportional to the rate of malignancy in upper lung fields.ConclusionConventional CTCS may be a missed opportunity to screen for upper lung field cancers in high risk patients. The ICER of FCT is better than screening for breast cancer screening (mammograms $80?k/QALY) and colon cancer (colonoscopy $6?k/QALY). Prospective studies are appropriate to define protocols for FCT.

Project description:ImportancePlatform trial design allows the introduction of new interventions after the trial is initiated and offers efficiencies to clinical research. However, limited guidance exists on the economic resources required to establish and maintain platform trials.ObjectiveTo compare cost (US dollars) and time requirements of conducting a platform trial vs a series of conventional (nonplatform) trials using a real-life example.Design, setting, and participantsFor this economic evaluation, an online survey was administered to a group of international experts (146 participants) with publication records of platform trials to elicit their opinions on cost and time to set up and conduct platform, multigroup, and 2-group trials. Using the reported entry dates of 10 interventions into Systemic Therapy in Advancing Metastatic Prostate Cancer: Evaluation of Drug Efficacy, the longest ongoing platform trial, 3 scenarios were designed involving a single platform trial (scenario 1), 1 multigroup followed by 5 2-group trials (scenario 2), and a series of 10 2-group trials (scenario 3). All scenarios started with 5 interventions, then 5 more interventions were either added to the platform or evaluated independently. Simulations with the survey results as inputs were used to compare the platform vs conventional trial designs. Data were analyzed from July to September 2021.ExposurePlatform trial design.Main outcomes and measuresTotal trial setup and conduct cost and cumulative duration.ResultsAlthough setup time and cost requirements of a single trial were highest for the platform trial, cumulative requirements of setting up a series of multiple trials in scenarios 2 and 3 were larger. Compared with the platform trial, there was a median (IQR) increase of 216.7% (202.2%-242.5%) in cumulative setup costs for scenario 2 and 391.1% (365.3%-437.9%) for scenario 3. In terms of total cost, there was a median (IQR) increase of 17.4% (12.1%-22.5%) for scenario 2 and 57.5% (43.1%-69.9%) for scenario 3. There was a median (IQR) increase in cumulative trial duration of 171.1% (158.3%-184.3%) for scenario 2 and 311.9% (282.0%-349.1%) for scenario 3. Cost and time reductions in the platform trial were observed in both the initial and subsequently evaluated interventions.Conclusions and relevanceAlthough setting up platform trials can take longer and be costly, the findings of this study suggest that having a single infrastructure can improve efficiencies with respect to costs and efforts.

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A cost analysis of intensified vs conventional multifactorial therapy in individuals with type 2 diabetes: a post hoc analysis of the Steno-2 study.

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A cost analysis of intensified vs conventional multifactorial therapy in individuals with type 2 diabetes: a post hoc analysis of the Steno-2 study.

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