Change In Quality-adjusted Life Years Research Articles

Transforaminal versus posterior lumbar interbody fusion for symptomatic single-level spondylolisthesis (LIFT): a multicentre controlled, patient blinded, randomised non-inferiority trial

The effectiveness of transforaminal lumbar interbody fusion (TLIF) compared to posterior lumbar interbody fusion (PLIF) in patients with single-level spondylolisthesis has not been substantiated. To address the evidence gap, a well-powered randomized controlled non-inferiority trial comparing the effectiveness of TLIF with PLIF, entitled the Lumbar Interbody Fusion Trial (LIFT), was conducted. In a multicenter randomized controlled non-inferiority trial among five Dutch hospitals, 161 patients were randomly allocated to either TLIF or PLIF (1:1), stratified according to study site. Patients and statisticians were blinded for group assignment. All patients were over 18 years old with symptomatic single-level degenerative, isthmic or iatrogenic lumbar spondylolisthesis, and eligible for lumbar interbody fusion surgery through a posterior approach. The primary outcome was change in disability measured with the Oswestry Disability Index (ODI) from preoperative to one year postoperative. The non-inferiority limit was set to 7.0 points based on the MCID of ODI. Secondary outcomes were change in quality-adjusted life years (QALY) assessed with EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) and Short Form Health Survey (SF-36), as well as back and leg pain (Numerical rating scale, NRS), anxiety and depression (Hospital Anxiety Depression Scale; HADS), perioperative blood loss, duration of surgery, duration of hospitalization, and complications. Trial registration: Netherlands Trial Registry, number 5722 (registration date March 30, 2016), Lumbar Interbody Fusion Trial (LIFT): A randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis. Patients were included between August 2017 and November 2020. The total study population was 161 patients. Total loss-to-follow-up after one year was 16 patients. Per-protocol analysis included 66 patients in each group. In the TLIF group (mean age 61.6, 36 females), ODI improved from 46.7 to 20.7, whereas in the PLIF group (mean age 61.9, 41 females), it improved from 46.0 to 24.9. This difference (-4.9, 90% CI-12.2 to+2.4) did not reach the non-inferiority limit of 7.0 points in ODI. A significant difference in the secondary outcome measurement, QALY (SF-36), was observed in favor of TLIF (P<0.05). However, this was not clinically relevant. No difference was found for all other secondary outcome measurements; PROMs (EQ-5D, NRS leg/back, HADS), perioperative blood loss, duration of surgery, duration of hospitalization, and perioperative and postoperative complications. For patients with single-level spondylolisthesis, TLIF is non-inferior to PLIF in terms of clinical effectiveness. Disability (measured with ODI) did not differ over time between groups. No funding was received for this trial.

The Health Impact of Waiting for Elective Procedures in the NHS in England: A Modeling Framework Applied to Coronary Artery Bypass Graft and Total Hip Replacement.

The aim of this study is to demonstrate a practical framework that can be applied to estimate the health impact of changes in waiting times across a range of elective procedures in the National Health Service (NHS) in England. We apply this framework by modeling 2 procedures: coronary artery bypass graft (CABG) and total hip replacement (THR). We built a Markov model capturing health pre- and postprocedure, including the possibility of exiting preprocedure to acute NHS care or self-funded private care. We estimate the change in quality-adjusted life-years (QALYs) over a lifetime horizon for 10 subgroups defined by sex and Index of Multiple Deprivation quintile groups and for 7 alternative scenarios. We include 18 wk as a baseline waiting time consistent with current NHS policy. The model was populated with data from routinely collected data sets where possible (Hospital Episode Statistics, Patient-Reported Outcome Measures, and Office for National Statistics Mortality records), supplemented by the academic literature. Compared with 18 wk, increasing the wait time to 36 wk resulted in a mean discounted QALY loss in the range of 0.034 to 0.043 for CABG and 0.193 to 0.291 for THR. The QALY impact of longer NHS waits was greater for those living in more deprived areas, partly as fewer patients switch to private care. The proposed framework was applied to 2 different procedures and patient populations. If applied to an expanded group of procedures, it could provide decision makers with information to inform prioritization of waiting lists. There are a number of limitations in routine data on waiting for elective procedures, primarily the lack of information on people still waiting. We present a modeling framework that allows for an estimation of the health impact (measured in quality-adjusted life-years) of waiting for elective procedures in the NHS in England.We apply our model to waiting for coronary artery bypass graft (CABG) and total hip replacement (THR). Increasing the wait for THR results in a larger health loss than an equivalent increase in wait for CABG.This model could potentially be used to estimate the impact across an expanded group of procedures to inform prioritization of activities to reduce waiting times.

Benefit-Harm Analysis of Earlier Initiation of Triple Therapy for Prevention of Acute Exacerbation in Patients with Chronic Obstructive Pulmonary Disease.

Rationale: Reducing the risk of exacerbation is a fundamental goal in managing stable chronic obstructive pulmonary disease (COPD). Guidelines recommend triple therapy (inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting β-agonists) only as a stepup from dual therapy (long-acting muscarinic antagonists and long-acting β-agonists) for patients at continued high risk of exacerbation, because of the trade-off of an increased risk of pneumonia associated with inhaled corticosteroid-containing therapies. However, there is little evidence on the optimum timing of initiating triple therapy. Objectives: To perform a benefit-harm analysis to evaluate the net benefit of earlier initiation of triple therapy for the prevention of acute exacerbations in patients with COPD compared with standard timing recommended in current guidelines. Methods: We used a validated whole-disease microsimulation model of COPD in the Canadian general population aged ⩾40 years to determine the benefit versus harm of earlier initiation of triple therapy over a 20-year time horizon compared with standard care. We assessed net change in quality-adjusted life-years (QALYs) from the reduction in risk of acute exacerbations and the increased risk of treatment-related pneumonia in subgroups of patients with COPD defined by exacerbation history, symptoms, and disease severity. Model parameters were determined from clinical trials and other published literature. Key parameters were varied in one-way sensitivity analysis. Results: In patients at high risk of acute exacerbation (54.7% female; mean age, 74.0 yr; 68% Global Initiative for Chronic Obstructive Lung Disease grades I and II), earlier initiation of triple therapy was associated with a net QALY gain of 4.8 per 100 patients with COPD over 20 years compared with standard care. The net QALY gain increased to 5.9 per 100 patients in the subgroup of patients with a high symptom burden (modified Medical Research Council dyspnea scale score, >1). Earlier initiation remained net beneficial in all subgroup and sensitivity analysis scenarios. Conclusions: Modeling suggests that earlier initiation of triple therapy is likely to be net beneficial for patients at high risk of acute exacerbation, with an even greater benefit to patients with a high symptom burden. Further clinical research is needed to verify these findings in empirical studies.

Economic Evaluation Alongside a Randomized Controlled Trial of Mindfulness-Based Cognitive Therapy in Healthy Adults.

This study aimed to conduct an economic evaluation of mindfulness-based cognitive therapy (MBCT) in healthy participants by performing cost-utility analysis (CUA) and cost-benefit analysis (CBA). CUA was carried out from a healthcare sector perspective and CBA was from the employer's perspective in parallel with a randomized controlled trial. Of the 90 healthy participants, 50 met the inclusion criteria and were randomized to the MBCT group (n = 25) or wait-list control group (n = 25). In the CUA, intervention costs and healthcare costs were included, while the mean difference in the change in quality-adjusted life years (QALYs) between the baseline and 16-week follow-up was used as an indicator of effect. Incremental cost-effectiveness ratio (ICER) was produced, and uncertainty was addressed using non-parametric bootstrapping with 5000 replications. In the CBA, the change in productivity losses was reflected as a benefit, while the costs included intervention and healthcare costs. The net monetary benefit was calculated, and uncertainty was handled with 5000 bootstrapping. Healthcare costs were measured with the self-report Health Service Use Inventory. The purchasing power parity in 2019 was used for currency conversion. In the CUA, incremental costs and QALYs were estimated at JPY 19,700 (USD 189) and 0.011, respectively. The ICER then became JPY 1,799,435 (USD 17,252). The probability of MBCT being cost-effective was 92.2% at the threshold of 30,000 UK pounds per QALY. The CBA revealed that MBCT resulted in increased costs (JPY 24,180) and improved work productivity (JPY 130,640), with a net monetary benefit of JPY 106,460 (USD 1021). The probability of the net monetary benefit being positive was 69.6%. The results suggested that MBCT may be more cost-effective from a healthcare sector perspective and may be cost-beneficial from the employer's perspective.

Impact of cetuximab plus cisplatin alone and cetuximab plus cisplatin and paclitaxel regimen on humanistic outcome in head and neck cancer

BackgroundThe prevalence of head and neck cancer (HNC) is increasing rapidly, and the prognosis is poor in the advance stage. For the patient suffering from advance stage HNC, the improvement in quality of life and decrease mortality remain as the mainstay of treatment. The aim was to assess the change in quality-adjusted life-years (QALYs) in recurrent or metastatic HNC patients receiving cetuximab plus cisplatin and cetuximab plus cisplatin-paclitaxel.MethodsIt was a single-centric prospective-observational study. Patients were divided into two cohorts based on the chemotherapy regimens they were prescribed. Patients in cohort 1 were prescribed with cetuximab and cisplatin and in cohort 2 were prescribed with cetuximab, cisplatin, and paclitaxel. The QALYs were the primary outcome of the study, and it was calculated using EQ-5D-5L instrument. Patients were followed until the completion of the therapy, i.e., six chemotherapy cycles. The statistical analysis was carried out using SPSS for descriptive and inferential analysis.ResultsAmongst 175 patients screened, 100 patients were enrolled which further distributed in cohorts 1 and 2 equally. The mean QALYs were 0.016 and 0.017 at the time of diagnosis, i.e., before initiation of chemotherapy for patients in cohorts 1 and 2, respectively. At every chemotherapy cycle, the QALYs were calculated. After the completion of six chemotherapy cycles, the mean QALYs were 0.029 and 0.032 for patients in cohorts 1 and 2, respectively.ConclusionThe three-drug therapy consisting of cetuximab, cisplatin, and paclitaxel has shown significant improvement in patients’ QALYs compared to two-drug regimens of cetuximab and cisplatin. Thus, if the therapy consisted of three-drug regimen is used instead of two-drug regimen, it will have a positive impact on humanistic outcome in recurrent or metastatic HNC patients.

Factors influencing short-term effectiveness and efficiency of the care provided by Dutch general practice mental health professionals.

This study examined whether factors related to general practice mental health professionals (GP-MHPs), that is, characteristics of the professional, the function, and the care provided, were associated with short-term effectiveness and efficiency of the care provided by GP-MHPs to adults in Dutch general practice. A prospective cohort study was conducted among 320 adults with anxiety or depressive symptoms who had an intake consultation with GP-MHPs (n = 64). Effectiveness was measured in terms of change in quality-adjusted life years (QALYs) 3 months after intake; and efficiency in terms of net monetary benefit (NMB) at 3-month follow-up. A range of GP-MHP-related predictors and patient-related confounders was considered. Patients gained on average 0.022 QALYs at 3-month follow-up. The mean total costs per patient during the 3-month follow-up period (€3,864; 95% confidence interval [CI]: €3,196-€4,731) decreased compared to that during the 3 months before intake (€5,220; 95% CI: €4,639-€5,925), resulting largely from an increase in productivity. Providing mindfulness and/or relaxation exercises was associated with QALY decrement. Having longer work experience as a GP-MHP (≥2 years) and having 10-20 years of work experience as a mental health care professional were negatively associated with NMB. Furthermore, a higher number of homework exercises tended to be related to less efficient care. Finally, being self-employed and being seconded from an organization in which primary care and mental health care organizations collaborate were related to a positive NMB, while being seconded from a mental health organization tended towards such a relationship. Findings seem to imply that the care provided by GP-MHPs contributes to improving patients' functioning. Some GP-MHP-related characteristics appear to influence short-term effectiveness and efficiency of the care provided. Further research is needed to confirm and better explain these findings and to examine longer-term effects.

Cost-Effectiveness of Virtual Reality Cognitive Behavioral Therapy for Psychosis: Health-Economic Evaluation Within a Randomized Controlled Trial.

BackgroundEvidence was found for the effectiveness of virtual reality-based cognitive behavioral therapy (VR-CBT) for treating paranoia in psychosis, but health-economic evaluations are lacking.ObjectiveThis study aimed to determine the short-term cost-effectiveness of VR-CBT.MethodsThe health-economic evaluation was embedded in a randomized controlled trial evaluating VR-CBT in 116 patients with a psychotic disorder suffering from paranoid ideation. The control group (n=58) received treatment as usual (TAU) for psychotic disorders in accordance with the clinical guidelines. The experimental group (n=58) received TAU complemented with add-on VR-CBT to reduce paranoid ideation and social avoidance. Data were collected at baseline and at 3 and 6 months postbaseline. Treatment response was defined as a pre-post improvement of symptoms of at least 20% in social participation measures. Change in quality-adjusted life years (QALYs) was estimated by using Sanderson et al’s conversion factor to map a change in the standardized mean difference of Green’s Paranoid Thoughts Scale score on a corresponding change in utility. The incremental cost-effectiveness ratios were calculated using 5000 bootstraps of seemingly unrelated regression equations of costs and effects. The cost-effectiveness acceptability curves were graphed for the costs per treatment responder gained and per QALY gained.ResultsThe average mean incremental costs for a treatment responder on social participation ranged between €8079 and €19,525, with 90.74%-99.74% showing improvement. The average incremental cost per QALY was €48,868 over the 6 months of follow-up, with 99.98% showing improved QALYs. Sensitivity analyses show costs to be lower when relevant baseline differences were included in the analysis. Average costs per treatment responder now ranged between €6800 and €16,597, while the average cost per QALY gained was €42,030.ConclusionsThis study demonstrates that offering VR-CBT to patients with paranoid delusions is an economically viable approach toward improving patients’ health in a cost-effective manner. Long-term effects need further research.Trial RegistrationInternational Standard Randomised Controlled Trial Number (ISRCTN) 12929657; http://www.isrctn.com/ISRCTN12929657

Cost-effectiveness Analysis of the Elder-Friendly Approaches to the Surgical Environment (EASE) Intervention for Emergency Abdominal Surgical Care of Adults Aged 65 Years and Older

The Elder-Friendly Approaches to the Surgical Environment (EASE) initiative is a novel approach to acute surgical care for elderly patients. To determine the cost-effectiveness of EASE. An economic evaluation from the perspective of the health care system was conducted as part of the controlled before-and-after EASE study at 2 tertiary care centers, the University of Alberta Hospital and Foothills Medical Centre. Participants included elderly adults (aged ≥65 years) admitted for emergency abdominal surgery between 2014 and 2017. Data were analyzed from April 2018 to February 2019. Data were captured at both control and intervention sites before and after implementation of the EASE intervention. Resource use was captured over 6 months of follow-up and was converted to costs. Utility was measured with the EuroQol Five-Dimensions Three-Levels instrument at 6 weeks and 6 months of follow-up. The differences-in-differences method was used to estimate the association of the intervention with cost and quality-adjusted life-years. For a subset of participants, self-reported out-of-pocket health care costs were collected using the Resource Use Inventory at 6 months. A total of 675 participants were included (mean [SD] age, 75.3 [7.9] years; 333 women [49.3%]), 289 in the intervention group and 386 in the control group. The mean (SD) cost per control participant was $36 995 ($44 169) before EASE and $35 032 ($43 611) after EASE (all costs are shown in 2018 Canadian dollars). The mean (SD) cost per intervention participant was $56 143 ($74 039) before EASE and $39 001 ($59 854) after EASE. Controlling for age, sex, and Clinical Frailty Score, the EASE intervention was associated with a mean (SE) cost reduction of 23.5% (12.5%) (P = .02). The change in quality-adjusted life-years observed associated with the intervention was not statistically significant (mean [SE], 0.00001 [0.0001] quality-adjusted life-year; P = .72). The Resource Use Inventory was collected for 331 participants. The mean (SE) odds ratio for having 0 out-of-pocket expenses because of the intervention, compared with having expenses greater than 0, was 15.77 (3.37) (P = .02). Among participants with Resource Use Inventory costs greater than 0, EASE was not associated with a change in spending (mean [SE] reduction associated with EASE, 19.1% [45.2%]; P = .57). This study suggests that the EASE intervention was associated with a reduction in costs and no change in quality-adjusted life-years. In locations that lack capacity to implement this intervention, costs to increase capacity should be weighed against the estimated costs avoided.

Cost-effectiveness of 12 weeks of supervised treatment compared to written advice in patients with knee osteoarthritis: a secondary analysis of the 2-year outcome from a randomized trial

To assess the 24-month cost-effectiveness of supervised treatment compared to written advice in knee osteoarthritis (OA). 100 adults with moderate-severe OA not eligible for total knee replacement (TKR) randomized to a 12-week individualized, supervised treatment (exercise, education, diet, insoles and pain medication) or written advice. Effectiveness was measured as change in quality-adjusted life years (QALYs) from baseline to 24 months, including data from baseline, 3, 6, 12 and 24 months, while healthcare costs and transfer payments were derived from national registries after final follow-up. Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated. A sensitivity analysis resampling existing data was conducted and the probability of cost-effectiveness was estimated using a 22,665 Euros/QALY threshold. In a sensitivity analysis, cost-effectiveness was calculated for different costs of the supervised treatment (actual cost in study; cost in private practice; and in-between cost). Average costs were similar between groups (6,758 Euros vs 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156). In the primary analysis excluding deaths, this led the supervised treatment to be cost-effective, compared to written advice. The sensitivity analysis demonstrated that the results were sensitive to changes in the cost of treatment, but in all scenarios the supervised treatment was cost-effective (ICERs of 6,229 to 20,688 Euros/QALY). From a 24-month perspective, a 12-week individualized, supervised treatment program is cost-effective compared to written advice in patients with moderate-severe knee OA not eligible for TKR. ClinicalTrials.gov number: NCT01535001.

Effect of Depression Screening After Acute Coronary Syndromes on Quality of Life

Patients with acute coronary syndrome (ACS) and elevated depressive symptoms are at increased risk for recurrent cardiovascular events and mortality, worse quality of life, and higher health care costs. These observational findings prompted multiple scientific panels to advise universal depression screening in survivors of ACS prior to evidence from randomized screening trials. To determine whether systematically screening for depression in survivors of ACS improves quality of life and depression compared with usual care. A 3-group multisite randomized trial enrolled 1500 patients with ACS from 4 health care systems between November 1, 2013, and March 31, 2017, with follow-up ending July 31, 2018. Patients were eligible if they had been hospitalized for ACS in the previous 2 to 12 months and had no prior history of depression. All analyses were performed on an intention-to-treat basis. Patients with ACS were randomly assigned 1:1:1 to receive (1) systematic depression screening using the 8-item Patient Health Questionnaire, with notification of primary care clinicians and provision of centralized, patient-preference, stepped depression care for those with positive screening results (8-item Patient Health Questionnaire score ≥10; screen, notify, and treat, n = 499); (2) systematic depression screening, with notification of primary care clinicians for those with positive screening results (screen and notify, n = 501); and (3) usual care (no screening, n = 500). The primary outcome was change in quality-adjusted life-years. The secondary outcome was depression-free days. Adverse effects and mortality were assessed by patient interview and hospital records. A total of 1500 patients (424 women and 1076 men; mean [SD] age, 65.9 [11.5] years) were randomized in the 18-month trial. Only 71 of 1000 eligible survivors of ACS (7.1%) had elevated 8-item Patient Health Questionnaire scores indicating depressive symptoms at screening. There were no differences in mean (SD) change in quality-adjusted life-years (screen, notify and treat, -0.06 [0.20]; screen and notify, -0.06 [0.20]; no screen, -0.06 [0.18]; P = .98) or cumulative mean (SD) depression-free days (screen, notify and treat, 343.1 [179.0] days; screen and notify, 351.3 [175.0] days; no screen, 339.0 [176.6] days; P = .63). Harms including death, bleeding, or sleep difficulties did not differ among groups. In patients with ACS without a history of depression, systematic depression screening with or without providing depression treatment did not alter quality-adjusted life-years, depression-free days, or harms. ClinicalTrials.gov identifier: NCT01993017.

Cost utility analysis of pharmacist counseling care for breast cancer chemotherapy outpatients.

Chemotherapy for cancer is increasingly implemented in the outpatient setting. Pharmacists contribute to cancer treatment by conducting counseling during outpatient chemotherapy visits. They provide guidance on drug treatment, side effects, and side effect countermeasures on every visit. However, there have been few economic evaluations of pharmacist involvement in outpatient chemotherapy. Therefore, we performed a cost utility analysis. We assigned usual care (control) and pharmacist counseling to two groups of 19 patients receiving outpatient chemotherapy for breast cancer at Gifu Municipal hospital. Quality of life was measured at three timepoints before and during chemotherapy treatment using the EuroQol 5 dimension instrument (EQ-5D). EQ-5D values across the timepoints were 0.831, 0.757, and 0.791 for the control group, and 0.882, 0.883, and 0.921 for the pharmacist counseling group. The additional cost in the pharmacist counseling group was 2,227 yen per counseling session. The change in quality-adjusted life years (QALY) was a maximum of -0.021±0.186 in the control group and 0.007±0.199 in the pharmacist counseling group. The maximum cost for one QALY was 1,360,558 yen (≈12,460 US dollars). Pharmacists' counseling in outpatient cancer chemotherapy for breast cancer patients had an acceptable incremental cost-effect ratio, contributing to improved patient quality of life without significant additional expenditure to healthcare.

Cost-Effectiveness of Sentinel Lymph Node Biopsy for Head and Neck Cutaneous Squamous Cell Carcinoma

BackgroundSentinel lymph node biopsy (SLNB) has shown promise in identifying subclinical nodal metastasis in patients with high-risk cutaneous squamous cell carcinoma. However, low metastasis rates may indicate that performing such a procedure in all patients may be unnecessary and costly. Materials and methodsA decision model was developed to analyze costs and survival in patients with head and neck cutaneous squamous cell carcinoma based on their tumor and nodal metastasis staging and whether or not they received an SLNB. Incremental cost-effectiveness ratios were calculated based on the change in quality-adjusted life years (QALYs) and costs (US$) between the different options, with a threshold of $100,000 to determine the most cost-effective strategy. One-way, two-way, and probabilistic sensitivity analyses were performed to validate the results. ResultsNot performing an SLNB results in 12.26 QALYs and a cost of $3712.98. Performing an SLNB resulted in a 0.59 decrease in QALYs and an increase in cost of $1379.58 for an incremental cost-effectiveness ratio of -2338.27. This trend remained the same across all tumor stages and remained consistent within most sensitivity analyses. ConclusionsIn patients with head and neck cutaneous squamous cell carcinoma, the most cost-effective strategy is to not perform SLNBs, regardless of the patient’s stage. Low rates of nodal metastasis in addition to low disease-specific death rates were the significant factors in this outcome. Increasing the sensitivity of SLNB would not impact this recommendation unless the rate of nodal metastasis was significantly higher.

Cost-Utility Study of the Economics of Bunion Correction Surgery.

Bunion correction surgery is a very common procedure to improve patients' pain and physical function attributable to a misaligned first metatarsophalangeal joint. The objective of this study was to apply a health utility framework to estimate the cost utility of bunion correction surgery. Patients were prospectively recruited from the population of patients seen in a lower-extremity orthopedic clinic and scheduled for isolated bunion surgery. Participants completed EuroQoL's EQ-5D(3L) to measure patients' current general health preoperatively and 6 months postoperatively. Participants' change in quality-adjusted life years (QALYs) were calculated by comparing the difference between postoperative utility values and preoperative utility values. The study had 95 patients representing 53% of eligible patients. The mean preoperative utility value was 0.6816 and the mean postoperative value was 0.7451, a statistically significant difference denoting an improvement in self-reported health. The cost per QALY, assuming gains in health accrued for 15 years, was $4911 (the 95% confidence interval ranged from $4736 to $5088). The cost per QALY was highest among the oldest patients. Assuming gains in health accrued for 20 years, the cost per QALY was $3922. This study demonstrated that bunion correction surgery was inexpensive relative to its gains in health compared with commonly applied thresholds for women and men in all age groups, though the gains were not uniformly distributed across age categories. Future research should examine the impact of recurrence on the robustness of these findings. Level III, comparative study.

Cost-effectiveness of adult spinal deformity surgery in a military healthcare system.

OBJECTIVEAdult spinal deformity surgery is an effective way of treating pain and disability, but little research has been done to evaluate the costs associated with changes in health outcome measures. This study determined the change in quality-adjusted life years (QALYs) and the cost per QALY in patients undergoing spinal deformity surgery in the unique environment of a military healthcare system (MHS).METHODSPatients were enrolled between 2011 and 2017. Patients were eligible to participate if they were undergoing a thoracolumbar spinal fusion spanning more than 6 levels to treat an underlying deformity. Patients completed the 36-Item Short Form Health Survey (SF-36) prior to surgery and 6 and 12 months after surgery. The authors used paired t-tests to compare SF-36 Physical Component Summary (PCS) scores between baseline and postsurgery. To estimate the cost per QALY of complex spine surgery in this population, the authors extended the change in health-related quality of life (HRQOL) between baseline and follow-up over 5 years. Data on the cost of surgery were obtained from the MHS and include all facility and physician costs.RESULTSHRQOL and surgical data were available for 49 of 91 eligible patients. Thirty-one patients met additional criteria allowing for cost-effectiveness analysis. Over 12 months, patients demonstrated significant improvement (p < 0.01) in SF-36 PCS scores. A majority of patients met the minimum clinically important difference (MCID; 83.7%) and substantive clinical benefit threshold (SCBT; 83.7%). The average change in QALY was an increase of 0.08. Extended across 5 years, including the 3.5% discounting per year, study participants increased their QALYs by 0.39, resulting in an average cost per QALY of $181,649.20. Nineteen percent of patients met the < $100,000/QALY threshold with half of the patients meeting the < $100,000/QALY mark by 10 years. A sensitivity analysis showed that patients who scored below 60 on their preoperative SF-36 PCS had an average increase in QALYs of 0.10 per year or 0.47 over 5 years.CONCLUSIONSWith a 5-year extended analysis, patients who receive spinal deformity surgery in the MHS increased their QALYs by 0.39, with 19% of patients meeting the $100,000/QALY threshold. The majority of patients met the threshold for MCID and SCBT at 1 year postoperatively. Consideration of preoperative functional status (SF-36 PCS score < 60) may be an important factor in determining which patients benefit the most from spinal deformity surgery.

Cost-effectiveness of Mindfulness-based Stress Reduction Versus Cognitive Behavioral Therapy or Usual Care Among Adults With Chronic Low Back Pain

Economic evaluation alongside a randomized trial of cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) versus usual care alone (UC) for chronic low back pain (CLBP). To determine 1-year cost-effectiveness of CBT and MBSR compared to 33 UC. CLBP is expensive in terms of healthcare costs and lost productivity. Mind-body interventions have been found effective for back pain, but their cost-effectiveness is unexplored. A total of 342 adults in an integrated healthcare system with CLBP were randomized to receive MBSR (n = 116), CBT (n = 113), or UC (n = 113). CBT and MBSR were offered in 8-weekly 2-hour group sessions. Cost-effectiveness from the societal perspective was calculated as the incremental sum of healthcare costs and productivity losses over change in quality-adjusted life-years (QALYs). The payer perspective only included healthcare costs. This economic evaluation was limited to the 301 health plan members enrolled ≥180 days in the years pre-and postrandomization. Compared with UC, the mean incremental cost per participant to society of CBT was $125 (95% confidence interval, CI: -4103, 4307) and of MBSR was -$724 (CI: -4386, 2778)-that is, a net saving of $724. Incremental costs per participant to the health plan were $495 for CBT over UC and -$982 for MBSR, and incremental back-related costs per participant were $984 for CBT over UC and -$127 for MBSR. These costs (and cost savings) were associated with statistically significant gains in QALYs over UC: 0.041 (0.015, 0.067) for CBT and 0.034 (0.008, 0.060) for MBSR. In this setting CBT and MBSR have high probabilities of being cost-effective, and MBSR may be cost saving, as compared with UC for adults with CLBP. These findings suggest that MBSR, and to a lesser extent CBT, may provide cost-effective treatment for CLBP for payers and society. 2.

Gastroenterologist and nurse management of symptoms after pelvic radiotherapy for cancer: an economic evaluation of a clinical randomized controlled trial (the ORBIT study).

BackgroundOver 20 distressing gastrointestinal symptoms affect many patients after pelvic radiotherapy, but in the United Kingdom few are referred for assessment. Algorithmic-based treatment delivered by either a consultant gastroenterologist or a clinical nurse specialist has been shown in a randomized trial to be statistically and clinically more effective than provision of a self-help booklet. In this study, we assessed cost-effectiveness.MethodsOutcomes were measured at baseline (pre-randomization) and 6 months. Change in quality-adjusted life years (QALYs) was the primary outcome for the economic evaluation; a secondary analysis used change in the bowel subset score of the modified Inflammatory Bowel Disease Questionnaire (IBDQ-B). Intervention costs, British pounds 2013, covered visits with the gastroenterologist or nurse, investigations, medications and treatments. Incremental outcomes and incremental costs were estimated simultaneously using multivariate linear regression. Uncertainty was handled non-parametrically using bootstrap with replacement.ResultsThe mean (SD) cost of treatment was £895 (499) for the nurse and £1101 (567) for the consultant. The nurse was dominated by usual care, which was cheaper and achieved better outcomes. The mean cost per QALY gained from the consultant, compared to usual care, was £250,455; comparing the consultant to the nurse, it was £25,875. Algorithmic care produced better outcomes compared to the booklet only, as reflected in the IBDQ-B results, at a cost of ~£1,000.ConclusionAlgorithmic treatment of radiation bowel injury by a consultant or a nurse results in significant symptom relief for patients but was not found to be cost-effective according to the National Institute for Health and Care Excellence (NICE) criteria.

Interdisciplinary pharmacometrics linking oseltamivir pharmacology, influenza epidemiology and health economics to inform antiviral use in pandemics.

A modular interdisciplinary platform was developed to investigate the economic impact of oseltamivir treatment by dosage regimen under simulated influenza pandemic scenarios. The pharmacology module consisted of a pharmacokinetic distribution of oseltamivir carboxylate daily area under the concentration-time curve at steady state (simulated for 75mg and 150mg twice daily regimens for 5days) and a pharmacodynamic distribution of viral shedding duration obtained from phase II influenza inoculation data. The epidemiological module comprised a susceptible, exposed, infected, recovered (SEIR) model to which drug effect on the basic reproductive number (R0 ), a measure of transmissibility, was linked by reduction of viral shedding duration. The number of infected patients per population of 100000 susceptible individuals was simulated for a series of pandemic scenarios, varying oseltamivir dose, R0 (1.9 vs. 2.7), and drug uptake (25%, 50%, and 80%). The number of infected patients for each scenario was entered into the health economics module, a decision analytic model populated with branch probabilities, disease utility, costs of hospitalized patients developing complications, and case-fatality rates. Change in quality-adjusted life years was determined relative to base case. Oseltamivir 75mg relative to no treatment reduced the median number of infected patients, increased change in quality-adjusted life years by deaths averted, and was cost-saving under all scenarios; 150mg relative to 75mg was not cost effective in low transmissibility scenarios but was cost saving in high transmissibility scenarios. This methodological study demonstrates proof of concept that the disciplines of pharmacology, disease epidemiology and health economics can be linked in a single quantitative framework.

The Continuing Story of the Cost-Effectiveness of Photoselective Vaporization of the Prostate versus Transuretheral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Obstruction

BackgroundIn 2008, a UK assessment of technologies for benign prostatic obstruction concluded negatively about photoselective vaporization of the prostate (PVP), and the 2010 National Institute for Health and Care Excellence guidance caused several UK institutions to abandon PVP. ObjectiveTo reassess the costs and effects of PVP versus transurethral resection of the prostate (TURP) on the basis of most recent data. MethodsThe same model was used as in 2008. Transition probabilities were estimated using a Bayesian approach updating the 2008 estimates with data from two meta-analyses and data from GOLIATH, the latest and largest trial comparing PVP with TURP. Utility estimates were from the 2008 assessment, and estimates of resource utilization and costs were updated. Effectiveness was measured in quality-adjusted life-years gained, and costs are in UK pounds. The balance between costs and effects was addressed by multivariate sensitivity analysis. ResultsIf the 2010 National Institute for Health and Care Excellence analysis would have updated the cost-effectiveness analysis with figures from its own meta-analysis, it would have estimated the change in quality-adjusted life-years at −0.01 (95% confidence interval [CI] −0.05 to 0.01) instead of at −0.11 (95% CI −0.31 to −0.01) as in the 2008 analysis. The GOLIATH estimate of −0.01 (95% CI −0.07 to 0.02) strengthens the conclusion of near equivalence. Estimates of additional costs vary from £491 (£21−£1286) in 2008 to £111 (−£315 to £595) for 2010 and to £109 (−£204 to £504) for GOLIATH. PVP becomes cost saving if more than 32% can be carried out as a day case in the United Kingdom. ConclusionsThe available evidence indicates that PVP can be a cost-effective alternative for TURP in a potentially broad group of patients.

Factors Predicting Cost-effectiveness of Adult Spinal Deformity Surgery at 2 Years

ObjectiveTo identify preoperative factors that lead to cost-effectiveness at 2 years' follow-up in the setting of surgical treatment for adult spinal deformity. MethodsRetrospective analysis of a prospective, consecutive, multicenter database including 514 patients who underwent surgery for adult spinal deformity. The change in quality-adjusted life-years (QALY) was calculated from the 2-year change in Oswestry Disability Index (ODI). Medicare coding was used to determine the direct costs based on diagnosis-related group and Relative Value Unit reimbursement. Analysis was performed to determine which factors were associated with a cost/QALY less than $100,000, making the procedure cost-effective. ResultsThe average QALY change for all patients in this study was 0.15 and the average cost/QALY was $243,761.97. A total of 56 patients (10.4%) had a cost/QALY of less than $100,000 at 2-year follow-up. Those patients were mostly female (89%), with a mean age of 60 years and the following diagnoses: 18 (32.1%) adult idiopathic scoliosis, 12 (35.7%) adult de novo scoliosis, 87 (14.3%) sagittal imbalance, and 10 (17.9%) other scoliosis. The Health-Related Quality of Life ODI and Scoliosis Research Society (SRS) instruments were all associated with cost-effectiveness except SRS–Mental. Factors associated with cost-effectiveness were age greater than 55 years, adult de novo scoliosis, prior surgery, higher preoperative sagittal vertical axis, lower maximum Cobb angles, 8 or fewer fusion levels, lower blood loss, worse global alignment classification, and global sagittal malalignment. Combined anterior-posterior surgeries were negatively associated with cost-effectiveness. Preoperative ODI scores between 60 and 70 and SRS Pain and Activity subscores more than 4 minimally clinically important difference points below the normative values had the highest percentage of cost-effective patients. ConclusionsThe QALY change is 0.15 and the cost/QALY of adult deformity surgery is $243,761.97 at 2 years. Patients with higher preoperative morbidity are more likely to be cost-effective with a cost/QALY less than $100,000.

A Naturopathic Approach to the Prevention of Cardiovascular Disease

Objective:To determine the cost-effectiveness of a worksite-based naturopathic (individualized lifestyle counseling and nutritional medicine) approach to primary prevention of cardiovascular disease (CVD).Methods:Economic evaluation alongside a pragmatic, multi-worksite, randomized controlled trial comparing enhanced usual care (EUC; usual care plus biometric screening) to the addition of a naturopathic approach to CVD prevention (NC+EUC).Results:After 1 year, NC+EUC resulted in a net decrease of 3.3 (confidence interval: 1.7 to 4.8) percentage points in 10-year CVD event risk (number needed to treat = 30). These risk reductions came with average net study-year savings of $1138 in societal costs and $1187 in employer costs. There was no change in quality-adjusted life years across the study year.Conclusions:A naturopathic approach to CVD primary prevention significantly reduced CVD risk over usual care plus biometric screening and reduced costs to society and employers in this multi-worksite—based study. Trial Registration clinicaltrials.gov Identifier: NCT00718796.