scholarly journals STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bastiaan C. ter Meulen ◽  
Johanna M. van Dongen ◽  
Marinus van der Vegt ◽  
Henry C. Weinstein ◽  
Raymond W. J. G. Ostelo
Keyword(s):  
Statistical Analysis ◽  
Cost Effectiveness ◽  
Intervention Group ◽  
Statistical Analysis Plan ◽  
Pain Medication ◽  
Oral Pain ◽  
Oral Pain Medication ◽  
Group 2 ◽  
The Cost ◽  
Star Trial

Abstract Background Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a priori statistical analysis plan describes the methodology of the analysis for the STAR trial that assesses the (cost-)effectiveness of TESI during the acute stage of sciatica (< 8 weeks). Methods The STAR trial is a multicentre, randomized controlled, prospective trial (RCT) investigating the (cost-)effectiveness of TESI by making a three-group comparison among patients with acute sciatica due to a herniated lumbar disc (< 8 weeks): (1) TESI combined with levobupivacaine added to oral pain medication (intervention group 1) versus oral pain medication alone (control group), (2) intervention group 1 versus transforaminal epidural injection with levobupivacaine and saline solution added to oral pain medication (intervention group 2), and (3) intervention group 2 versus control group. Co-primary outcomes were physical functioning (Roland Morris Disability Questionnaire), pain intensity (10-point numerical rating scale), and global perceived recovery (7-point Likert scale, dichotomized into ‘recovered’ and ‘not recovered’). For all three comparisons, we defined the following minimal clinically relevant between-group differences: two points for pain intensity (range 0–10), four points for physical functioning (range 0–24) and a 20% difference in recovery rate. Secondary outcomes are health-related quality of life (EQ-5D-5L) and patient satisfaction (7-point Likert scale) and surgery rate. We also collected resource use data to perform an economic evaluation. Analyses will be conducted by intention-to-treat with p < 0.05 (two-tailed) for all three comparisons. Effects will be estimated using mixed models by maximum likelihood. For each comparison, mean differences, or difference in proportions, between groups will be tested per time point and an overall mean difference, or difference in proportions, between groups during the complete duration of follow-up (6 months) will be estimated. In the economic evaluation, Multivariate Imputation by Chained Equations will be used to handle missing data. Cost and effect differences will be estimated using seemingly unrelated regression, and uncertainty will be estimated using bootstrapping techniques. Discussion This statistical analysis plan provides detailed information on the intended analysis of the STAR trial, which aims to deliver evidence about the (cost-)effectiveness of TESI during the acute phase of sciatica (< 8 weeks). Trial registration Dutch National trial register NTR4457 (6 March 2014)

Cost-effectiveness of prophylactic antibiotics to prevent pneumonia in patients treated with chemoradiotherapy (CRT) for locally advanced head and neck carcinoma (LAHNC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6075-6075 ◽  
Author(s):  
Janneke Ham ◽  
Chantal Driessen ◽  
Mathijs P Hendriks ◽  
W. Edward Fiets ◽  
Bas Kreike ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Locally Advanced ◽  
Intervention Group ◽  
Pain Medication ◽  
Cost Effectiveness Analysis ◽  
Prophylactic Antibiotics ◽  
Clinical Effects ◽  
Effectiveness Analysis ◽  
The Cost ◽  
The Impact

6075 Background: Recently, we reported about a prospective randomized study (PANTAP-study) investigating the effect of prophylactic antibiotics in LAHNC pts treated with CRT. We did not show a reduction in pneumonias, but did find a significant decrease in the number of hospitalizations. Detailed quality of life (QoL) results have been reported elsewhere. Now we present the results of the cost-effectiveness analysis. Methods: A multicenter study was performed in LAHNC pts treated with CRT, i.e.cisplatin weekly or 3-weekly combined with radiotherapy for 42 or 49 days. The standard treatment group (STG) received no prophylactic antibiotics; the intervention group (IG) received prophylactic antibiotics, i.e. amoxicillin/clavulanic acid, from day 29 until 14 days after completion of CRT. QoL questionnaires, including EQ-5D, QLQ-C30, EORTC Head&Neck35 and PSSHN, were taken before start of CRT, before start of antibiotics, at the end of CRT and at the end of follow up. Costs of hospitalization, prophylactic antibiotics, pain medication and anti-emetics were taken into account for the cost-effectiveness analysis. Results: A total of 94 pts were randomized; 48 pts to the STG and 47 pts to the IG. Between the STG and IG we found a difference per patient in costs of hospitalization of €2076 and €682 (p = 0.03), respectively, but not in the costs for pain medication per patient €78 and €46, respectively, (p = 0.382). The total costs of hospitalization in combination with prophylactic antibiotics, pain medication and anti-emetics were €2462 and €1037 (p = 0.046) in the STG and IG respectively, leading to a difference in total costs per patient of €1425 in favor of the IG. There were no significant differences in QoL between the groups. Conclusions: Prophylactic antibiotics during CRT for LAHNC did not reduce the rate of pneumonias, but reduced the number of hospitalizations in the IG, which led to a significant reduction in costs. Given the lack of adverse clinical effects, the same QoL, the cost savings and the impact of costs of hospitalization on health care globally, we recommend the use of prophylactic antibiotics in LAHNC pts receiving CRT. Clinical trial information: NCT01598402.

scholarly journals Economic Evaluation Protocol and Statistical Analysis Plan for the Cost-Effectiveness of a Novel Australian Stroke Telemedicine Program; the Victorian Stroke Telemedicine (VST) program

2021 ◽  
Vol 11 ◽  
Author(s):  
Dominique A. Cadilhac ◽  
Lauren Sheppard ◽  
Joosup Kim ◽  
Elise Tan ◽  
Lan Gao ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Cost Effectiveness ◽  
Intravenous Thrombolysis ◽  
Statistical Analysis Plan ◽  
Additional Patient ◽  
Patient Level Data ◽  
Patient Level ◽  
Level Data ◽  
Second Year ◽  
The Cost

Introduction: Telemedicine can address limited access to medical specialists in rural hospitals. Stroke provides an important case study because: it is a major cause of disease burden; effective treatments to reduce disability (e.g., thrombolysis) can be provided within the initial hours of stroke onset; careful selection of patients is needed by skilled doctors to minimize adverse events from thrombolysis; and there are major treatment gaps (only about half of regional hospitals in Australia provide thrombolysis for stroke). Few economic analyses have been undertaken on telestroke and the majority have been simulation models. The aim of this protocol and statistical analysis plan is to outline the methods for the cost-effectiveness evaluation of a large, multicentre acute stroke telemedicine program being conducted in Victoria, Australia.Methods: Using a historical- and prospective-controlled design, we will compare patient-level data obtained in the 12 months prior to the Victorian Stroke Telemedicine (VST) program implementation and during the first 12 months of VST to determine the incremental difference in costs and patient outcomes at 3 and 12 months. Secondary aims include assessing the cost per additional patient receiving intravenous thrombolysis and the cost per additional patient receiving intravenous thrombolysis within 60 min. Tertiary aims include assessing the potential longer-term cost-effectiveness in the second year of the program at the hospitals to determine whether any program benefits are sustained once site coordinators are no longer employed; and modeling the potential net life-time costs and benefits from a societal perspective. Multivariable uncertainty and one-way sensitivity analyses will be performed to assess the robustness of results.Results: Sixteen hospitals participated. Patient-level data collection including 12-month outcomes for the cohorts obtained in the first and second year of the program for each hospital was completed in January 2020.Conclusion: The results from this real-world study with patient-level data will provide high quality evidence of the costs, health benefits and policy implications of telestroke programs, including the potential for application in other locations within Australia or other countries with similar health system delivery and financing.

447 Cost-Effectiveness of a 3-Year Tele-OSA Intervention

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A177-A177
Author(s):  
Jaejin An ◽  
Dennis Hwang ◽  
Jiaxiao Shi ◽  
Amy Sawyer ◽  
Aiyu Chen ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Willingness To Pay ◽  
Incremental Cost ◽  
Economic Benefits ◽  
Small Sample ◽  
Apnea Hypopnea Index ◽  
Obstructive Sleep ◽  
Group 2 ◽  
The Cost

Abstract Introduction Trial-based tele-obstructive sleep apnea (OSA) cost-effectiveness analyses have often been inconclusive due to small sample sizes and short follow-up. In this study, we report the cost-effectiveness of Tele-OSA using a larger sample from a 3-month trial that was augmented with 2.75 additional years of epidemiologic follow-up. Methods The Tele-OSA study was a 3-month randomized trial conducted in Kaiser Permanente Southern California that demonstrated improved adherence in patients receiving automated feedback messaging regarding their positive airway pressure (PAP) use when compared to usual care. At the end of the 3 months, participants in the intervention group pseudo-randomly either stopped or continued receiving messaging. This analysis included those participants who had moderate-severe OSA (Apnea Hypopnea Index &gt;=15) and compared the cost-effectiveness of 3 groups: 1) no messaging, 2) messaging for 3 months only, and 3) messaging for 3 years. Costs were derived by multiplying medical service use from electronic medical records times costs from Federal fee schedules. Effects were average nightly hours of PAP use. We report the incremental cost per incremental hour of PAP use as well as the fraction acceptable. Results We included 256 patients with moderate-severe OSA (Group 1, n=132; Group 2, n=79; Group 3, n=45). Group 2, which received the intervention for 3 months only, had the highest costs and fewest hours of use and was dominated by the other two groups. Average 1-year costs for groups 1 and 3 were $6035 (SE, $477) and $6154 (SE, $575), respectively; average nightly hours of PAP use were 3.07 (SE, 0.23) and 4.09 (SE, 0.42). Compared to no messaging, messaging for 3 years had an incremental cost ($119, p=0.86) per incremental hour of use (1.02, p=0.03) of $117. For a willingness-to-pay (WTP) of $500 per year ($1.37/night), 3-year messaging has a 70% chance of being acceptable. Conclusion Long-term Tele-OSA messaging was more effective than no messaging for PAP use outcomes but also highly likely cost-effective with an acceptable willingness-to-pay threshold. Epidemiologic evidence suggests that this greater use will yield both clinical and additional economic benefits. Support (if any) Tele-OSA study was supported by the AASM Foundation SRA Grant #: 104-SR-13

scholarly journals Cost-Effectiveness of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People: The REducing Falls with Orthoses and a Multifaceted Podiatry Intervention Trial Findings

Gerontology ◽  
2018 ◽  
Vol 64 (5) ◽  
pp. 503-512 ◽  
Author(s):  
Belen Corbacho ◽  
Sarah Cockayne ◽  
Caroline Fairhurst ◽  
Catherine E. Hewitt ◽  
Kate Hicks ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Older People ◽  
Usual Care ◽  
Incidence Rate ◽  
Intervention Group ◽  
Cost Effective ◽  
Falls Prevention ◽  
Data Set ◽  
Life Years ◽  
The Cost

Background: Falls are a major cause of morbidity among older people. Multifaceted interventions may be effective in preventing falls and related fractures. Objective: To evaluate the cost-effectiveness alongside the REducing Falls with Orthoses and a Multifaceted podiatry intervention (REFORM) trial. Methods: REFORM was a pragmatic multicentre cohort randomised controlled trial in England and Ireland; 1,010 participants (> 65 years) were randomised to receive either a podiatry intervention (n = 493), including foot and ankle strengthening exercises, foot orthoses, new footwear if required, and a falls prevention leaflet, or usual podiatry treatment plus a falls prevention leaflet (n = 517). Primary outcome: incidence of falls per participant in the 12 months following randomisation. Secondary outcomes: proportion of fallers and quality of life (EQ-5D-3L) which was converted into quality-adjusted life years (QALYs) for each participant. Differences in mean costs and QALYs at 12 months were used to assess the cost-effectiveness of the intervention relative to usual care. Cost-effectiveness analyses were conducted in accordance with National Institute for Health and Clinical Excellence reference case standards, using a regression-based approach with costs expressed in GBP (2015 price). The base case analysis used an intention-to-treat approach on the imputed data set using multiple imputation. Results: There was a small, non-statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73–1.05, p = 0.16). Participants allocated to the intervention group accumulated on average marginally higher QALYs than the usual care participants (mean difference 0.0129, 95% CI –0.0050 to 0.0314). The intervention costs were on average GBP 252 more per participant compared to the usual care participants (95% CI GBP –69 to GBP 589). Incremental cost-effectiveness ratios ranged between GBP 19,494 and GBP 20,593 per QALY gained, below the conventional National Health Service cost-effectiveness thresholds of GBP 20,000 to GBP 30,000 per additional QALY. The probability that the podiatry intervention is cost-effective at a threshold of GBP 30,000 per QALY gained was 0.65. The results were robust to sensitivity analyses. Conclusion: The benefits of the intervention justified the moderate cost. The intervention could be a cost-effective option for falls prevention when compared with usual care in the UK.

scholarly journals COST-EFFECTIVENESS ANALYSIS OF THE COLLABORATIVE STEPPED CARE INTERVENTION FOR LATE-LIFE DEPRESSION

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S876-S877
Author(s):  
Shiyu Lu ◽  
Gloria H Y Wong ◽  
Terry Lum ◽  
Tianyin Liu
Keyword(s):  
Cost Effectiveness ◽  
Intervention Group ◽  
Late Life ◽  
Community Dwelling ◽  
Stepped Care ◽  
Care Group ◽  
Care Utilization ◽  
Late Life Depression ◽  
Care Intervention ◽  
The Cost

Abstract Late-life depression is a burden on society because it is costly and have a significant adverse effect on the quality of life. The aim of this study is to evaluate the cost-effectiveness of the collaborative stepped care intervention for depression among community-dwelling older adults compared to care as usual from a societal perspective. The intervention was piloted from 2016-2019 in Hong Kong. The study used a two-armed quasi-experimental design. Eventually, 412 older people were included (314 collaborative stepped care, 98 care as usual). Baseline measures and 12-month follow-up measures were assessed using questionnaires. We applied the 5-level EQ-5D version (EQ-5D-5L) and the Client Service Receipt Inventory (CSRI) respectively measuring quality-adjusted life-year (QALY) and health care utilization. The average annual direct medical cost in the intervention group was USD 6,589 (95% C.I., 4,979 to 8,199) compared to US$ 6,167 (95% C.I., 3,702 to 8,631) in the care as usual group. The average QALYs gained was 0.036 higher in the collaborative stepped care group, leading to an incremental cost-effectiveness ratio (ICER) of US$ 11,722 per QALY, lower than the cost-effectiveness threshold suggested by The National Institute for Health and Clinical Excellence. The study showed that collaborative stepped care was a cost-effective intervention for late-life depression over service as usual.

scholarly journals Decreased costs and retained QoL due to the ‘PACE Steps to Success’ intervention in LTCFs: cost-effectiveness analysis of a randomized controlled trial

BMC Medicine ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Anne B. Wichmann ◽  
◽  
Eddy M. M. Adang ◽  
Kris C. P. Vissers ◽  
Katarzyna Szczerbińska ◽  
...  
Keyword(s):  
Palliative Care ◽  
Cost Effectiveness ◽  
Intervention Group ◽  
Cost Savings ◽  
Daily Routine ◽  
Significant Cost ◽  
Term Care ◽  
Care Programme ◽  
The Cost

Abstract Background The number of residents in long-term care facilities (LTCFs) in need of palliative care is growing in the Western world. Therefore, it is foreseen that significantly higher percentages of budgets will be spent on palliative care. However, cost-effectiveness analyses of palliative care interventions in these settings are lacking. Therefore, the objective of this paper was to assess the cost-effectiveness of the ‘PACE Steps to Success’ intervention. PACE (Palliative Care for Older People) is a 1-year palliative care programme aiming at integrating general palliative care into day-to-day routines in LTCFs, throughout seven EU countries. Methods A cluster RCT was conducted. LTCFs were randomly assigned to intervention or usual care. LTCFs reported deaths of residents, about whom questionnaires were filled in retrospectively about resource use and quality of the last month of life. A health care perspective was adopted. Direct medical costs, QALYs based on the EQ-5D-5L and costs per quality increase measured with the QOD-LTC were outcome measures. Results Although outcomes on the EQ-5D-5L remained the same, a significant increase on the QOD-LTC (3.19 points, p value 0.00) and significant cost-savings were achieved in the intervention group (€983.28, p value 0.020). The cost reduction mainly resulted from decreased hospitalization-related costs (€919.51, p value 0.018). Conclusions Costs decreased and QoL was retained due to the PACE Steps to Success intervention. Significant cost savings and improvement in quality of end of life (care) as measured with the QOD-LTC were achieved. A clinically relevant difference of almost 3 nights shorter hospitalizations in favour of the intervention group was found. This indicates that timely palliative care in the LTCF setting can prevent lengthy hospitalizations while retaining QoL. In line with earlier findings, we conclude that integrating general palliative care into daily routine in LTCFs can be cost-effective. Trial registration ISRCTN14741671.

scholarly journals Comparison of the ‘11+ Kids’ injury prevention programme and a regular warmup in children’s football (soccer): a cost effectiveness analysis

2018 ◽  
Vol 53 (5) ◽  
pp. 309-314 ◽  
Author(s):  
Roland Rössler ◽  
Evert Verhagen ◽  
Nikki Rommers ◽  
Jiri Dvorak ◽  
Astrid Junge ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Injury Prevention ◽  
Healthcare Costs ◽  
Intervention Group ◽  
Cost Effectiveness Analysis ◽  
Prevention Programme ◽  
Control Group ◽  
Effectiveness Analysis ◽  
The Cost ◽  
Injury Prevention Programme

ObjectiveTo evaluate a potential reduction in injury related healthcare costs when using the ‘11+ Kids’ injury prevention programme compared with a usual warmup in children’s football.MethodsThis cost effectiveness analysis was based on data collected in a cluster randomised controlled trial over one season from football teams (under-9 to under-13 age groups) in Switzerland. The intervention group (INT) replaced their usual warmup with ‘11+ Kids’, while the control group (CON) warmed up as usual. Injuries, healthcare resource use and football exposure (in hours) were collected prospectively. We calculated the mean injury related costs in Swiss Francs (CHF) per 1000 hours of football. We calculated the cost effectiveness (the direct net healthcare costs divided by the net health effects of the ‘11+ Kids’ intervention) based on the actual data in our study (trial based) and for a countrywide implementation scenario (model based).ResultsCosts per 1000 hours of exposure were CHF228.34 (95% CI 137.45, 335.77) in the INT group and CHF469.00 (95% CI 273.30, 691.11) in the CON group. The cost difference per 1000 hours of exposure was CHF−240.66 (95%CI −406.89, −74.32). A countrywide implementation would reduce healthcare costs in Switzerland by CHF1.48 million per year. 1002 players with a mean age of 10.9 (SD 1.2) years participated. During 76 373 hours of football, 99 injuries occurred.ConclusionThe ‘11+ Kids’ programme reduced the healthcare costs by 51% and was dominant (ie, the INT group had lower costs and a lower injury risk) compared with a usual warmup. This provides a compelling case for widespread implementation.

Sign in / Sign up

Export Citation Format

Share Document