scholarly journals RESEARCH PROTOCOL: Cervical Arthroplasty Cost Effectiveness Study (CACES) Economic Evaluation of Anterior Cervical Discectomy With Arthroplasty Versus Anterior Cervical Discectomy With Fusion in the Surgical Treatment of Cervical Degenerative Disc Disease, a Randomized Controlled Trial.

2022 ◽  
Author(s):  
Valérie N.E. Schuermans ◽  
Anouk Y.J.M. Smeets ◽  
Toon F.M. Boselie ◽  
Math M.J.J. Candel ◽  
Inez Curfs ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Surgical Treatment ◽  
Controlled Trial ◽  
Cost Effective ◽  
Anterior Cervical Discectomy ◽  
Disc Disease ◽  
Cervical Discectomy ◽  
Randomized Controlled ◽  
Multi Level

Abstract IntroductionTo date, there is no consensus on which anterior surgical technique is more cost-effective in treating cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multi-level symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). The extent to which kinematics, surgery-induced fusion, natural history and progression of disease play a role in the development of CASP remain unclear. Anterior cervical discectomy with arthroplasty (ACDA) is another treatment option that is thought to reduce the incidence of CASP by preserving motion in the operated segment. While ACDA is often discouraged, as the implant costs are higher while the clinical outcomes are similar to ACDF, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long-term.Methods and analysisIn this randomized controlled trial, patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a healthcare and societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline, and every six months until four years post-surgery.DiscussionHigh-quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking; to date, there are no prospective trials from a societal perspective. Considering the ageing of the population and the rising healthcare costs, there is an urgent need for a solid clinical cost-effectiveness trial addressing this question.

scholarly journals Cost-effectiveness of postoperative rehabilitation after surgery for lumbar disc herniation: an analysis based on a randomized controlled trial

2020 ◽  
Vol 32 (5) ◽  
pp. 733-740
Author(s):  
Rune T. Paulsen ◽  
Jan Sørensen ◽  
Leah Y. Carreon ◽  
Mikkel Ø. Andersen
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Controlled Trial ◽  
Lumbar Disc ◽  
Cost Effective ◽  
Postoperative Rehabilitation ◽  
Randomized Controlled ◽  
Home Group ◽  
Effectiveness Analysis

OBJECTIVEThe aim of this study was to examine whether routine referral to municipal postoperative rehabilitation is cost-effective in comparison to no referral after surgery for lumbar disc herniation (LDH).METHODSOne hundred forty-six patients scheduled for primary discectomy due to LDH were included. This secondary analysis, based on data from a previous randomized controlled trial, compared costs and quality-adjusted life years (QALYs) between two groups of patients recovering from LDH surgery: one group of patients received a referral for municipal physical rehabilitation (REHAB) and the other group was sent home without a referral to any postoperative rehabilitation (HOME). Primary outcomes were QALYs calculated from the EQ-5D utility score, societal costs, and incremental cost-effectiveness ratios (ICERs). The main cost-effectiveness analysis used intention-to-treat data, whereas sensitivity analyses included as-treated data. Questionnaires were collected after 1, 3, 6, 12, and 24 months postoperatively.RESULTSThe main cost-effectiveness analysis showed a small, insignificant incremental QALY of 0.021 and an incremental cost of €211.8 for the REHAB group compared to the HOME group, resulting in an ICER of €10,085. In the as-treated sensitivity analysis, the REHAB group had poorer outcomes and higher costs compared to the HOME group.CONCLUSIONSRoutine referral to municipal physical rehabilitation in patients recovering from LDH surgery was not cost-effective compared to no referral.Clinical trial registration no.: NCT03505918 (clinicaltrials.gov)

Randomized controlled trial of pregabalin for analgesia after surgical treatment of intervertebral disc disease in dogs

2020 ◽  
Vol 49 (5) ◽  
pp. 905-913
Author(s):  
Philipp A. Schmierer ◽  
Julia Tünsmeyer ◽  
Andrea Tipold ◽  
Sonja Hartnack‐Wilhelm ◽  
Piotr Lesczuk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Surgical Treatment ◽  
Intervertebral Disc ◽  
Controlled Trial ◽  
Intervertebral Disc Disease ◽  
Disc Disease ◽  
Randomized Controlled

scholarly journals Economic Evaluation of an Internet-Based Preventive Cognitive Therapy With Minimal Therapist Support for Recurrent Depression: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Nicola S Klein ◽  
Claudi LH Bockting ◽  
Ben Wijnen ◽  
Gemma D Kok ◽  
Evelien van Valen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Cost Effective ◽  
Recurrent Depression ◽  
Randomized Controlled ◽  
Dsm Iv ◽  
The Cost ◽  
Therapist Support

BACKGROUND Major depressive disorder (MDD) is highly recurrent and has a significant disease burden. Although the effectiveness of internet-based interventions has been established for the treatment of acute MDD, little is known about their cost effectiveness, especially in recurrent MDD. OBJECTIVES Our aim was to evaluate the cost effectiveness and cost utility of an internet-based relapse prevention program (mobile cognitive therapy, M-CT). METHODS The economic evaluation was performed alongside a single-blind parallel group randomized controlled trial. Participants were recruited via media, general practitioners, and mental health care institutions. In total, 288 remitted individuals with a history of recurrent depression were eligible, of whom 264 were randomly allocated to M-CT with minimal therapist support added to treatment as usual (TAU) or TAU alone. M-CT comprised 8 online lessons, and participants were advised to complete 1 lesson per week. The economic evaluation was performed from a societal perspective with a 24-month time horizon. The health outcomes were number of depression-free days according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (DSM-IV) criteria assessed with the Structured Clinical Interview for DSM-IV axis I disorders by blinded interviewers after 3, 12, and 24 months. Quality-adjusted life years (QALYs) were self-assessed with the three level version of the EuroQol Five Dimensional Questionnaire (EQ-5D-3L). Costs were assessed with the Trimbos and Institute for Medical Technology Assessment Questionnaire on Costs Associated with Psychiatric Illness (TiC-P). Incremental cost-effectiveness ratios were calculated and cost-effectiveness planes and cost-effectiveness acceptability curves were displayed to assess the probability that M-CT is cost effective compared to TAU. RESULTS Mean total costs over 24 months were €8298 (US $9415) for M-CT and €7296 (US $8278) for TAU. No statistically significant differences were found between M-CT and TAU regarding depression-free days and QALYs (P=.37 and P=.92, respectively). The incremental costs were €179 (US $203) per depression-free day and €230,816 (US $261,875) per QALY. The cost-effectiveness acceptability curves suggested that for depression-free days, high investments have to be made to reach an acceptable probability that M-CT is cost effective compared to TAU. Regarding QALYs, considerable investments have to be made but the probability that M-CT is cost effective compared to TAU does not rise above 40%. CONCLUSIONS The results suggest that adding M-CT to TAU is not effective and cost effective compared to TAU alone. Adherence rates were similar to other studies and therefore do not explain this finding. The participants scarcely booked additional therapist support, resulting in 17.3 minutes of mean total therapist support. More studies are needed to examine the cost effectiveness of internet-based interventions with respect to long-term outcomes and the role and optimal dosage of therapist support. Overall, more research is needed on scalable and cost-effective interventions that can reduce the burden of recurrent MDD. TRIAL REGISTRATION Netherlands Trial Register NTR2503; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2503 (Archived by WebCite at http://www.webcitation.org/73aBn41r3)

scholarly journals Can digitally collected PROMs as intervention for post-treatment adaption improve cost effectiveness: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
David Kuklinski ◽  
Laura Oschmann ◽  
Christoph Pross ◽  
Reinhard Busse ◽  
Alexander Geissler
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Data Privacy ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Cost Effective ◽  
Post Treatment ◽  
Study Patient ◽  
Randomized Controlled ◽  
Patient Reported

Abstract Background: The number of total knee and hip replacements (TKR/THR) has been increasing noticeably in high-income countries, such as Germany. Especially the number of revisions is expected to rise due to higher life expectancy and procedures performed on younger patients, impacting budgets of the health care systems. Quality transparency is the basis of holistic patient pathway optimization. Nevertheless, a nation-wide cross-sectoral assessment of quality from patient perspective does not yet exist. Several studies have shown that the use of patient-reported outcome measures (PROMs) is effective in measuring quality and for monitoring post-treatment recovery. For the first time in Germany, we test whether early detection of critical recovery paths using PROMs after TKR/THR improves the quality of care in a cost-effective way and can be recommended for implementation into standard care.Methods/design: The study is a two-arm multi-center patient-level randomized controlled trial. Patients from nine hospitals are included in the study. Patient-centered questionnaires are employed to regularly measure digitized PROMs of TKR/THR patients from the time of hospital admission until 12 months post-discharge. An expert consortium has defined PROM alert thresholds at 1, 3, and 6 months to signal critical recovery paths after TKR/THR. An algorithm alerts study assistants if patients are not recovering in line with expected recovery paths. The study assistants then contact patients and their physicians to investigate and, if needed, adjust the post-treatment protocol. By adding sickness funds’ claims data, the cost-effectiveness of the intervention can be analyzed.Discussion: The study is expected to deliver an important contribution to test PROMs as an intervention tool and examine the determinants of high-quality endoprosthetic care. Depending on a positive and cost-effective impact, the goal is to transfer the study design into standard care. During the trial design phase, several insights have been discovered, with opportunities for efficient digital monitoring limited by existing legacy care models. Digitalization in hospital processes and the implementation of digital tools still represents challenges for hospital personnel and patients. Furthermore, data privacy regulations and the separation between the in- and outpatient sector are additional roadblocks to effectively monitor and assess quality along the full patient pathway.Trial registration: German Clinical Trials Register: DRKS00019916. Registered 26 November 2019 – retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML& TRIAL_ID=DRKS00019916.

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