Cost-Utility Analysis of Geriatric Assessment and Management in Older Adults With Cancer: Economic Evaluation Within 5C Trial.

PURPOSE: Geriatric assessment (GA) is a guideline-recommended approach to optimize cancer management in older adults. We conducted a cost-utility analysis alongside the 5C randomized controlled trial to compare GA and management (GAM) plus usual care (UC) against UC alone in older adults with cancer. METHODS: The economic evaluation, conducted from societal and health care payer perspectives, used a 12-month time horizon. The Canadian 5C study randomly assigned patients to receive GAM or UC. Quality-adjusted life-years (QALYs) were measured using the EuroQol five dimension-5L questionnaire and health care utilization using cost diaries and chart reviews. We evaluated the incremental net monetary benefit (INMB) for the full sample and preselected subgroups. RESULTS: A total of 350 patients were included, of whom 173 received GAM and 177 UC. At 12 months, the average QALYs per patient were 0.728 and 0.751 for GAM and UC, respectively (ΔQALY, -0.023 [95% CI, -0.076 to 0.028]). Considering a societal perspective, the total average costs (in 2021 Canadian dollars) per patient were $46,739 and $45,177 for GAM and UC, respectively (ΔCost, $1,563 [95% CI, -$6,583 to $10,403]). At a cost-effectiveness threshold of $50,000/QALY, GAM was not cost-effective compared with UC (INMB, -$2,713 [95% CI, -$11,767 to $5,801]). The INMB was positive ($2,984 [95% CI, -$7,050 to $14,179]; probability of being cost-effective, 72%) for patients treated with curative intent, but remained negative for patients treated with palliative intent (INMB, -$9,909 [95% CI, -$24,436 to $4,153]). Findings were similar considering a health care payer perspective. CONCLUSION: To our knowledge, this is the first cost-utility analysis of GAM in cancer. GAM was cost-effective for patients with cancer treated with curative but not with palliative intent. The study provides further considerations for future adoption of GAM in practice.

Effectiveness of geriatric assessment and management in older cancer patients: a systematic review and meta-analysis.

BACKGROUND: Frailty and multimorbidity among older cancer patients affect treatment tolerance and efficacy. Comprehensive geriatric assessment and management is recommended to optimize cancer treatment, but its effect on various outcomes remains uncertain. OBJECTIVE: Our objective was to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) and cost-effectiveness studies comparing comprehensive geriatric assessment (with or without implementation of recommendations) to usual care in older cancer patients. METHODS: We searched MEDLINE, EMBASE, CINAHL, and Cochrane trials from inception to January 27, 2023, for RCTs and cost-effectiveness studies. Pooled estimates for outcomes were calculated using random-effects models. RESULTS: A total of 19 full-text articles representing 17 RCTs were included. Average participant age was 72-80 years, and 31%-62% were female. Comprehensive geriatric assessment type, mode of delivery, and evaluated outcomes varied across studies. Meta-analysis revealed no difference in risk of mortality (risk ratio [RR] = 1.08. 95% confidence interval [CI] = 0.91 to 1.29), hospitalization (RR = 0.92, 95% CI = 0.77 to 1.10), early treatment discontinuation (RR = 0.89, 95% CI = 0.67 to 1.19), initial dose reduction (RR = 0.99, 95% CI = 0.99 to 1.26), and subsequent dose reduction (RR = 0.87, 95% CI = 0.70 to 1.09). However, the risk of treatment toxicity was statistically significantly lower in the comprehensive geriatric assessment group (RR = 0.78, 95% CI = 0.70 to 0.86). No cost-effectiveness studies were identified. CONCLUSION: Compared with usual care, comprehensive geriatric assessment was not associated with a difference in risk of mortality, hospitalization, treatment discontinuation, and dose reduction but was associated with a lower risk of treatment toxicity indicating its potential to optimize cancer treatment in this population. Further research is needed to evaluate cost-effectiveness.

Cost-effectiveness analysis of genetic tools to predict treatment response in patients with cystic fibrosis.

BACKGROUND: Cystic fibrosis (CF) transmembrane conductance regulator (CFTR) modulator therapies show variable efficacy for patients with CF. Patient-derived predictive tools may identify individuals likely to respond to CFTRs, but are not in routine use. We aimed to determine the cost-utility of predictive tool-guided treatment with CFTRs as add-on to standard of care (SoC) for individuals with CF. METHODS: This economic evaluation compared two strategies using an individual level simulation: (i) Treat All, where all patients received CFTRs plus SoC and (ii) Test→Treat, where patients who tested positive on predictive tools received CFTRs plus SoC and those who tested negative received SoC only. We simulated 50,000 individuals over their lifetime, and estimated costs (2020 CAD) per quality-adjusted life year (QALY) from the healthcare payer's perspective, discounted at 1.5% annually. The model was populated using Canadian CF registry data and published literature. Probabilistic and deterministic sensitivity were conducted. RESULTS: The Treat All and Test→Treat and strategies yielded 22.41 and 21.36 QALYs, and cost $4.21 M and $3.15 M respectively. Results of probabilistic sensitivity analysis showed that Test→Treat was highly cost-effective compared to Treat All in 100% of simulations at cost-effectiveness thresholds as high as $500,000 per QALY. Test→Treat may save between $931 K to $1.1 M per QALY lost, depending on sensitivity and specificity of predictive tools. CONCLUSION: The use of predictive tools could optimize the health benefits of CFTR modulators while reducing costs. Our findings support the use of pre-treatment predictive testing and may help inform coverage and reimbursement policies for individuals with CF.

Pharmacotherapy vs. minimally invasive therapies as initial therapy for moderate-to-severe benign prostatic hyperplasia: a cost-effectiveness study.

BACKGROUND: Recently, minimally invasive therapies (MITs), such as water vapor thermal therapy (WVTT) and prostatic urethral lift (PUL) have become an alternative to surgery or pharmacotherapy to manage benign prostatic hyperplasia (BPH), offering symptom relief with a favorable safety profile. The objective of this study was to evaluate the cost-utility of MITs (WVTT and PUL) compared to pharmacotherapy as initial treatment for patients with moderate-to-severe BPH. METHODS: In this model-based economic evaluation we simulated BPH progression in men (mean age 65 years, average International Prostate Symptom Score 16.6) over their lifetime and estimated healthcare costs (from the US public payer perspective) per quality-adjusted life year (QALY), discounted at 3% annually. Various clinical scenarios were evaluated given that most men undergo several lifelong therapies up to surgical intervention and potentially thereafter. As such, in the study model men could receive up to three lines of therapy: (1) initial pharmacotherapy with MIT as second-line, and transurethral resection of the prostate (TURP) or pharmacotherapy as third-line; (2) initial MIT (WVTT or PUL) with MIT again, TURP or pharmacotherapy as second-line, and TURP as third-line. Model was populated using data from the published literature. Probabilistic analyses were performed. RESULTS: Initial treatment with WVTT led to the highest QALYs (13.05) and the lowest cost ($15,461). The cumulative QALYs and lifetime costs were 12.92 QALYs and $20,280 for pharmacotherapy followed by WVTT, 12.87 QALYs and $22,424 for pharmacotherapy followed by PUL, 12.86 QALYs and $20,930 for initial treatment with PUL. In the cost-utility analysis, WVTT as initial treatment dominated all three strategies, i.e., generated more QALYs at a lower cost. CONCLUSION: WVTT is an effective and cost-saving procedure, and may be an appropriate first-line alternative to pharmacotherapy for moderate-to-severe BPH patients who seek faster improvement and no lifelong commitment to daily medications.

Cost-utility of minimally invasive therapies vs. pharmacotherapy as initial therapy for benign prostatic hyperplasia A Canadian healthcare payer perspective.

INTRODUCTION: Recently, minimally invasive surgical therapies (MIST s) have become an alternative to surgery or pharmacotherapy to manage benign prostatic hyperplasia (BPH ). This study evaluated the cost-utility of water vapor thermal therapy (WVTT ) and prostatic urethral lift (PUL) compared to pharmacotherapy as initial treatment for patients with moderate-to-severe BPH. METHODS: In this model-based economic evaluation, we simulated BPH progression in men (mean age 65 years, average International Prostate Symptom Score 16.6) over their lifetime and estimated healthcare costs (from the Canadian healthcare payer perspective) per quality-adjusted life year (QALY), discounted at 1.5% annually. In the model, men could receive up to three lines of therapy: 1) initial pharmacotherapy with MIST as second-line, and TURP or pharmacotherapy as third-line; 2) initial MIST (WVTT or PUL) with MIST again, TURP, or pharmacotherapy as second-line, and TURP as third-line. The model was populated using data from the published literature. RESULTS: The expected lifetime QALYs and costs were 15.50 QALYs and $14 626 for initial treatment with WVTT, 15.35 QALYs and $11 795 for pharmacotherapy followed by WVTT, 15.29 QALYs and $13 582 for pharmacotherapy followed by PUL, and 15.29 QALYs and $19 151 for initial treatment with PUL. Strategies involving PUL procedures were dominated by strategies involving WVTT. The incremental cost per QALY gained was $18 873 for initial WVTT compared to initial pharmacotherapy followed by WVTT. CONCLUSIONS: WVTT appears to be a cost-effective procedure and may be an appropriate first-line alternative to pharmacotherapy for patients with BPH and prostate volume less than 80 cm3 who seek faster improvement and no lifelong commitment to daily medications.

Sex differences in baseline profiles and short-term outcomes in patients undergoing closure of patent foramen ovale.

Objectives: Although sex differences have been emphasized in stroke and congenital heart disease, there has been limited investigation into their role in patent foramen ovale (PFO) closure for secondary prevention of stroke. We aimed to explore differences by sex in baseline profiles, procedural characteristics, and short-term outcomes of patients undergoing transcatheter PFO closure. Methods: Data of adult patients undergoing transcatheter PFO closure at the Toronto General Hospital from 1997 to 2017 was retrospectively analyzed. Baseline information included demographic characteristics, medical history, diagnostic, and procedural information, and periprocedural complications. Post-closure outcomes were captured at index hospitalization and during the first follow-up. Results: From 1031 patients in the cohort sample, 80.7 % underwent closure for cryptogenic stroke and 44.7 % (n = 461) were females. We observed significant sex-related differences in baseline characteristics; females were younger, less likely to have a history of smoking, and less likely to have several cardiovascular risk factors at baseline (p < 0.05). The median time to first follow-up was 89 days for both groups. Recurrent stroke was observed in 0.1 % and TIA observed in 0.4 % of in the 'cryptogenic stroke/TIA' group; in the 'other indications' group, 1.4 % stroke and no TIA were reported. No significant differences were present between sexes. Conclusions: There were no differences in procedural and short-term outcomes between males and females undergoing transcatheter PFO closure, but significant baseline differences in risk factors were identified. There is a critical need for long-term, systematic studies to understand sex and gender differences in the PFO population.

Impact of direct-acting antiviral regimens on mortality and morbidity outcomes in patients with chronic hepatitis c: Systematic review and meta-analysis.

The long-term effects of direct-acting antiviral therapies (DAAs) for chronic hepatitis C (CHC) remain uncertain. The objective of this systematic review and meta-analysis was to assess the impact of DAAs on CHC progression and mortality. We searched Ovid MEDLINE, Ovid EMBASE and PubMed databases (January 2011 to March 2020) for studies that compared the efficacy of DAAs to a non-DAA control in patients with CHC. Main outcomes were the adjusted hazard ratios (HRs) for mortality, liver decompensation, HCC occurrence and recurrence. Pooled estimates of HRs were determined using random-effects meta-analyses with inverse variance weighting, with sensitivity analyses and meta-regression to explore the effects of clinical factors. We identified 39 articles for the primary analysis. Compared with unexposed individuals, patients treated with DAA had a reduced risk of death (HR; CI = 0.44; 0.38-0.52), decompensation (HR; CI = 0.54; 0.38- 0.76) and HCC occurrence (HR; CI = 0.72; 0.61- 0.86). The protective effect of DAA on HCC recurrence was less clear (HR; CI = 0.72; 0.44-1.16). Sustained virologic response (SVR) attainment was a significant predictor of reduced mortality (HR; CI = 0.33; 0.23-0.46), decompensation (HR; CI = 0.11; 0.05-0.24), HCC occurrence (HR; CI = 0.31; 0.27-0.37) and HCC recurrence (HR; CI = 0.32; 0.20-0.51). Meta-regression showed no evidence of effect modification by patient age, sex, presence of cirrhosis or length of follow-up. In conclusion, our findings show protective effects of DAA treatment and DAA-related SVR on CHC progression and mortality.

External validation of Leipzig-Halifax scores for aortic dissection in Armenia.

BACKGROUND: Few prognostic tools are currently available to predict hospital mortality in patients with acute type A aortic dissection. The aim of this study was to validate the performance of two existing risk-assessment tools, the original and the adjusted Leipzig-Halifax scorecards, to predict hospital mortality among Armenian patients with acute type A aortic dissection. METHODS: This retrospective cohort study included all consecutive patients with acute type A aortic dissection who were admitted to two tertiary cardiac centers in Armenia and underwent surgery from January 2008 to April 2018. We evaluated the predictive power of the original and adjusted Leipzig-Halifax scorecards using logistic regression analysis. RESULTS: Overall, 211 patients (76% males, mean age 57 ± 9 years) were included in the study, of whom 37 (17.5%) died during hospitalization. The adjusted Leipzig-Halifax score, but not the original Leipzig-Halifax score, was a significant predictor of hospital mortality. Patients with medium and high adjusted Leipzig-Halifax scores had a significantly higher odds of death compared to patients with low scores (odds ratio = 3.0 vs. 3.9, 95% confidence interval: 1.3-6.9 vs. 1.0-14.9, respectively). The areas under the receiver operating characteristic curves were 0.58 and 0.63, respectively, p > 0.05. CONCLUSION: The adjusted Leipzig-Halifax score performed slightly better than the original Leipzig-Halifax score in the Armenian acute type A aortic dissection population. The adjusted Leipzig-Halifax score should now be applied prospectively to generate more data for further validation and potential improvement.

Gender Differences in Utilization of Specialized Heart Failure Clinics.

BACKGROUND: Although heart failure (HF) prevalence is equally high among men and women, observed differences in the provision of care are still not fully understood. We sought to evaluate gender differences in patient profiles, diagnostic testing, medication prescription, and referrals in specialized multidisciplinary ambulatory HF clinics in Ontario. MATERIALS AND METHODS: Medical chart abstraction was conducted first by randomly selecting 9 (out of 34) HF clinics in Ontario, and then by randomly selecting 100 patient records in each clinic. Data on patient demographics, comorbidities, diagnostic tests, medication use, and referrals were abstracted, covering a period from the first clinic visit up to 1 year. Descriptive statistics and regression analysis were used to assess gender differences. RESULTS: Of the 884 patients, only 314 were women (35.5%). At the first clinic visit, women were older, had better systolic function but worse functional status, and had a lower prevalence of hyperlipidemia, diabetes, and smoking than men. There were more women with non-ischemic HF etiology than men (63.9% vs. 43.3%, p < 0.001). Adjusted analysis did not reveal gender differences in the average number of echocardiographic assessments and in the prescription rates of evidence-based medications. Men were twice more likely to be referred to electrophysiology studies than women (18.6% vs. 7.8%, p < 0.001). The rates of dietary counseling and cardiac rehabilitation referrals were similarly low in both groups. CONCLUSIONS: More men than women are treated in specialized ambulatory HF clinics. Although women differ from men in selected clinical characteristics, no major differences were observed in patient management. The reasons for low enrollment rates of women into the HF ambulatory clinics need further investigation.

Risk factors of postoperative complications after radical cystectomy with continent or conduit urinary diversion in Armenia.

To estimate the surgical volume and the incidence of in-hospital complications of RC in Armenia from 2005 to 2012, and to investigate potential risk factors of complications. The study utilized a retrospective chart review in a cohort of patients who had RC followed by either continent or conduit urinary diversion in all hospitals of Armenia from 2005 to 2012. A detailed chart review was conducted abstracting information on baseline demographic and clinical characteristics, surgical procedural details, postoperative management and in-hospital complications. Multivariable logistic regression analysis was applied to estimate the independent risk factors for developing 'any postoperative complication'. The total study sample included 273 patients (mean age = 58.5 years, 93.4 % men). Overall, 28.9 % (n = 79) of patients had at least one in-hospital complication. The hospital mortality rate was 4.8 % (n = 13). The most frequent types of complications were wound-related (10.3 %), gastrointestinal (9.2 %) and infectious (7.0 %). The ischemic heart disease (OR = 3.3, 95 % CI 1.5-7.4), perioperative transfusion (OR = 2.0, 1.1-3.6), glucose level [OR = 0.71 (0.63-0.95)], and hospital type (OR = 2.3, 95 % CI 1.1-4.7) were independent predictors of postoperative complications. The rate of RC complications in Armenia was similar to those observed in other countries. Future prospective studies should evaluate the effect of RC complications on long-term outcomes and costs in Armenia. Policy recommendations should address the issues regarding surgeon training and hospital volume to decrease the risk of RC complications.

Calcium-regulating peptide hormones and blood electrolytic balance in chronic heart failure.

Calcium-regulating system is important for the functional activity of myocardium. However, little is known about the role of this system in the pathogenesis of cardiovascular diseases. Blood samples from the patients with chronic heart failure (CHF) caused by ischaemic disease (coronary artery disease) (NYHA class I-IV) were used to analyze the levels of calcium, inorganic phosphate, sodium, potassium, parathyroid hormone (PTH) and parathyroid hormone-related protein (PTHrP). The heart beat rate and arterial blood pressure were chosen as additional tests for the functional status of cardiovascular system. The alteration of electrolytes homeostasis was found dependent on the severity of the pathology being maximally expressed in the NYHA class IV patients. Similar tendency was demonstrated for circulating PTH and PTHrP with the highest blood concentrations observed in patients of the NYHA class III and IV. The extent of these changes was found more pronounced in the female patients. It is suggested that the calcium-regulating hormonal system is involved in the pathogenesis of the ischaemic heart disease; however the sharp increase of PTH and PTHrP at the severe stages of pathology may play a compensatory role in maintaining the heart function.