Cost-effectiveness of endovascular treatment after 6-24 h in ischaemic stroke patients with collateral flow on CT-angiography: A model-based economic evaluation of the MR CLEAN-LATE trial.

BACKGROUND: The MR CLEAN-LATE trial has shown that patient selection for endovascular treatment (EVT) in the late window (6-24 h after onset or last-seen-well) based on the presence of collateral flow on CT-angiography is safe and effective. We aimed to assess the cost-effectiveness of late-window collateral-based EVT-selection compared to best medical management (BMM) over a lifetime horizon (until 95 years of age). MATERIALS AND METHODS: A model-based economic evaluation was performed from a societal perspective in The Netherlands. A decision tree was combined with a state-transition (Markov) model. Health states were defined by the modified Rankin Scale (mRS). Initial probabilities at 3-months post-stroke were based on MR CLEAN-LATE data. Transition probabilities were derived from previous literature. Information on short- and long-term resource use and utilities was obtained from a study using MR CLEAN-LATE and cross-sectional data. All costs are expressed in 2022 euros. Costs and quality-adjusted life years (QALYs) were discounted at a rate of 4% and 1.5%, respectively. The effect of parameter uncertainty was assessed using probabilistic sensitivity analysis (PSA). RESULTS: On average, the EVT strategy cost €159,592 (95% CI: €140,830-€180,154) and generated 3.46 QALYs (95% CI: 3.04-3.90) per patient, whereas the costs and QALYs associated with BMM were €149,935 (95% CI: €130,841-€171,776) and 2.88 (95% CI: 2.48-3.29), respectively. The incremental cost-effectiveness ratio per QALY and the incremental net monetary benefit were €16,442 and €19,710, respectively. At a cost-effectiveness threshold of €50,000/QALY, EVT was cost-effective in 87% of replications. DISCUSSION AND CONCLUSION: Collateral-based selection for late-window EVT is likely cost-effective from a societal perspective in The Netherlands.

Effectiveness of permissive weight bearing in surgically treated trauma patients with peri- and intra-articular fractures of the lower extremities: a prospective comparative multicenter cohort study.

PURPOSE: The aim of the present study was to investigate the effectiveness of a novel approach involving permissive weight bearing (PWB) in surgically treated trauma patients with peri- and intra-articular fractures of the lower extremities. METHODS: Prospective comparative multicenter cohort study in one level 1 trauma center and five level 2 trauma centers. Surgically treated trauma patients with peri- and intra-articular fractures of the lower extremities were included. Permissive weight bearing (PWB) in comparison to restricted weight bearing (RWB) was assessed over a 26-week post-surgery follow-up period. Patients' self-perceived outcome levels regarding activities of daily living (ADL), quality of life (QoL), pain and weight bearing compliance were used. RESULTS: This study included 106 trauma patients (N = 53 in both the PWB and RWB groups). Significantly better ADL and QoL were found in the PWB group compared to the RWB group at 2-, 6-, 12- and 26-weeks post-surgery. There were no significant differences in postoperative complication rates between the PWB and RWB groups. CONCLUSION: PWB is effective and is associated with a significantly reduced time to full weight bearing, and a significantly better outcome regarding ADL and QoL compared to patients who followed RWB regimen. Moreover, no significant differences in complication rates were found between the PWB and RWB groups. LEVEL OF EVIDENCE: Level II. REGISTRATION: This study is registered in the Dutch Trial Register (NTR6077). Date of registration: 01-09-2016.

Economic evaluations of nonpharmacological treatments for drug-resistant epilepsy: A systematic review.

This study was undertaken to systematically identify and critically appraise all published full economic evaluations assessing the cost-effectiveness of nonpharmacological interventions for patients with drug-resistant epilepsy. The Population, Intervention, Comparison, Outcome, Study criteria was used to design search strategies for the identification and selection of relevant studies. Literature search was performed using the MEDLINE (via PubMed), Embase, International Health Technology Assessment, National Institute for Health Research Economic Evaluation Database, and Cost-Effectiveness Analysis Registry databases to identify articles published between January 2000 and May 2023. Web of Science was additionally used to perform forward and backward referencing. Title, abstract, and full-text screening was performed by two independent researchers. The Consensus Health Economic Criteria (CHEC) checklist and Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 were applied for quality assessment. A total of 4470 studies were identified, of which 18 met our inclusion criteria. Twelve of the studies conducted model-based economic evaluation, and others were trial-based. Three studies showed that epilepsy surgery was cost-effective in adults, whereas this remained inconclusive for children (two positive, three negative). Three studies showed negative economic outcome for ketogenic diet in children. One of four studies showed positive results for self-management. For vagus nerve stimulation, one study showed positive results in adults and another one negative results in children. One recent study showed cost-effectiveness of responsive neurostimulation (RNS) in adults. Finally, one study showed promising but inconclusive results for deep brain stimulation (DBS). The mean scores for risk of bias assessment (based on CHEC) and for reporting quality (CHEERS 2022) were 95.8% and 80.5%, respectively. This review identified studies that assessed the cost-effectiveness of nonpharmacological treatments in both adults and children with drug-resistant epilepsy, suggesting that in adults, epilepsy surgery, vagus nerve stimulation, and RNS are cost-effective, and that DBS and self-management appear to be promising. In children, the cost-effectiveness of epilepsy surgery remains inconclusive. Finally, the use of ketogenic diet was shown not to be cost-effective. However, limited long-term data were available for newer interventions (i.e., ketogenic diet, DBS, and RNS).

Advocating uniformity in spine surgery: a practical disease-specific guideline for trial-based economic evaluations.

OBJECTIVES: Despite the availability of general and national guidelines for the conduct and reporting of economic evaluations, there is heterogeneity in economic evolutions concerning spine surgery. This is partly the result of differing levels of adherence to the existing guidelines and the lack of disease-specific recommendations for economic evaluations. The extensive heterogeneity in study design, follow-up duration and outcome measurements limit the comparability of economic evaluations in spine surgery. This study has three objectives: (1) to create disease-specific recommendations for the design and conduct of trial-based economic evaluations in spine surgery, (2) to define recommendations for reporting economic evaluations in spine surgery as a complement to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 checklist and (3) to discuss methodological challenges and defining the need for future research. DESIGN: A modified Delphi method according to the RAND/UCLA Appropriateness Method. SETTING: A four-step process was followed to create and validate disease-specific statements and recommendations for the conduct and reporting of trial-based economic evaluations in spine surgery. Consensus was defined as >75% agreement. PARTICIPANTS: A total of 20 experts were included in the expert group. Validation of the final recommendations was obtained in a Delphi panel, which consisted of 40 researchers in the field who were not included in the expert group. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure is a set of recommendations for the conduct and reporting, as a complement to the CHEERS 2022 checklist, of economic evaluations in spine surgery. RESULTS: A total of 31 recommendations are made. The Delphi panel confirmed consensus on all of the recommendations in the proposed guideline. CONCLUSION: This study provides an accessible and practical guideline for the conduct of trial-based economic evaluations in spine surgery. This disease-specific guideline is a complement to existing guidelines, and should aid in reaching uniformity and comparability.

Methodology of economic evaluations in spine surgery: a systematic review and qualitative assessment.

OBJECTIVES: The present study is a systematic review conducted as part of a methodological approach to develop evidence-based recommendations for economic evaluations in spine surgery. The aim of this systematic review is to evaluate the methodology and quality of currently available clinical cost-effectiveness studies in spine surgery. STUDY DESIGN: Systematic literature review. DATA SOURCES: PubMed, Web of Science, Embase, Cochrane, Cumulative Index to Nursing and Allied Health Literature, EconLit and The National Institute for Health Research Economic Evaluation Database were searched through 8 December 2022. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Studies were included if they met all of the following eligibility criteria: (1) spine surgery, (2) the study cost-effectiveness and (3) clinical study. Model-based studies were excluded. DATA EXTRACTION AND SYNTHESIS: The following data items were extracted and evaluated: pathology, number of participants, intervention(s), year, country, study design, time horizon, comparator(s), utility measurement, effectivity measurement, costs measured, perspective, main result and study quality. RESULTS: 130 economic evaluations were included. Seventy-four of these studies were retrospective studies. The majority of the studies had a time horizon shorter than 2 years. Utility measures varied between the EuroQol 5 dimensions and variations of the Short-Form Health Survey. Effect measures varied widely between Visual Analogue Scale for pain, Neck Disability Index, Oswestry Disability Index, reoperation rates and adverse events. All studies included direct costs from a healthcare perspective. Indirect costs were included in 47 studies. Total Consensus Health Economic Criteria scores ranged from 2 to 18, with a mean score of 12.0 over all 130 studies. CONCLUSIONS: The comparability of economic evaluations in spine surgery is extremely low due to different study designs, follow-up duration and outcome measurements such as utility, effectiveness and costs. This illustrates the need for uniformity in conducting and reporting economic evaluations in spine surgery.

Associations between muscle mass/strength and healthcare costs/use for patients with cancer: A systematic literature review.

PURPOSE: To review published scientific evidence evaluating the potential associations between muscle mass/strength and healthcare use/costs for patients with cancer. METHODS: In accordance with the predefined protocol for a systematic literature review, studies assessing potential associations between muscle mass/strength and healthcare costs/use in cancer patients were searched on MEDLINE (via Ovid) and on the NHS Economic Evaluation Database in September 2021. Study selection, data extraction and quality assessment were performed by two independent reviewers. RESULTS: Of 613 studies identified, five met our inclusion criteria. Various outcomes were investigated: for length of hospital stay, one out of three studies reported an association between lower muscle mass and longer hospital stay; for hospital admission, the two identified studies did not highlight muscle weakness as a predictor of hospital admission; for hospital readmission, one out of two studies reported that patients with lower muscle mass had higher rates of hospital readmission; for costs and cost-effectiveness, results of two randomized controlled trials were mixed, with total costs of the intervention higher in one study and lower in the other, leading to opposite cost-effectiveness results. CONCLUSION: Only five studies evaluating potential associations between mass/strength and healthcare use/costs have been highlighted within this systematic review. The amount of evidence is limited but the studies are also very heterogeneous in regards of study designs, sample size, and type of population included. This important heterogeneity prevents drawing strong conclusions. Because of limited data available, more high quality longitudinal studies are needed to further investigate the relationship between muscle mass/strength and healthcare costs/use.

Research protocol: Cervical Arthroplasty Cost Effectiveness Study (CACES): economic evaluation of anterior cervical discectomy with arthroplasty (ACDA) versus anterior cervical discectomy with fusion (ACDF) in the surgical treatment of cervical degenerative disc disease - a randomized controlled trial.

INTRODUCTION: To 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 remains 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 ANALYSIS: In 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 6 months until 4 years post-surgery. DISCUSSION: High-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 aging of the population and the rising healthcare costs, there is an urgent need for a solid clinical cost-effectiveness trial addressing this question. TRIAL REGISTRATION: ClinicalTrials.gov NCT04623593. Registered on 29 September 2020.

Does the Structure Matter? An External Validation and Health Economic Results Comparison of Event Simulation Approaches in Severe Obesity.

OBJECTIVES: As obesity-associated events impact long-term survival, health economic (HE) modelling is commonly applied, but modelling approaches are diverse. This research aimed to compare the events simulation and the HE outcomes produced by different obesity modelling approaches. METHODS: An external validation, using the Swedish obesity subjects (SOS) study, of three main structural event modelling approaches was performed: (1) continuous body mass index (BMI) approach; (2) risk equation approach; and (3) categorical BMI-related approach. Outcomes evaluated were mortality, cardiovascular events, and type 2 diabetes (T2D) for both the surgery and the control arms. Concordance between modelling results and the SOS study were investigated by different state-of-the-art measurements, and categorized by the grade of deviation observed (grades 1-4 expressing mild, moderate, severe, and very severe deviations). Furthermore, the costs per quality-adjusted life-year (QALY) gained of surgery versus controls were compared. RESULTS: Overall and by study arm, the risk equation approach presented the lowest average grade of deviation (overall grade 2.50; control arm 2.25; surgery arm 2.75), followed by the continuous BMI approach (overall 3.25; control 3.50; surgery 3.00) and by the categorial BMI approach (overall 3.63; control 3.50; surgery 3.75). Considering different confidence interval limits, the costs per QALY gained were fairly comparable between all structural approaches (ranging from £2,055 to £6,206 simulating a lifetime horizon). CONCLUSION: None of the structural approaches provided perfect external event validation, although the risk equation approach showed the lowest overall deviations. The economic outcomes resulting from the three approaches were fairly comparable.

Effectiveness and cost-effectiveness of dynamic bracing versus standard care alone in patients suffering from osteoporotic vertebral compression fractures: protocol for a multicentre, two-armed, parallel-group randomised controlled trial with 12 months of follow-up.

INTRODUCTION: Patients with osteoporosis may suffer from a fracture after minimal trauma. Osteoporotic vertebral compression fractures (OVCFs) are among the most common fractures, often leading to substantial pain. There is a need for evidence-based conservative treatment to aid in the management of OVCFs. The objective of this randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of dynamic bracing in addition to standard care for improving quality of life (QoL) in patients suffering from an OVCF. METHODS AND ANALYSIS: Ninety-eight postmenopausal women from two academic and four community hospitals with a recent symptomatic thoracolumbar OVCF will be randomised into either the standard care or dynamic bracing group. In the dynamic bracing group, the Spinova Osteo orthosis will be used in addition to standard care. Standard care comprises pain control with analgesics, physical therapy and osteoporosis medication. The primary outcome parameter is QoL 1 year after inclusion, as measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41). Secondary outcome parameters are pain, pain medication used, functional disability, sagittal spinal alignment, recurrence rate of OVCFs and physical activity in daily life. A trial-based economic evaluation consisting of both cost-effectiveness analysis and cost-utility analysis will be performed based on empirical data obtained in the RCT. A process evaluation will assess the feasibility of dynamic bracing. All outcomes will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Medical Ethics Committee, University Hospital Maastricht and Maastricht University (METC azM/UM) (NL74552.068.20/METC 20-055). Patients will be included only after verification of eligibility and obtaining written informed consent. Results will be disseminated via the Dutch National Osteoporosis Patient Society and via publications and conferences. TRIAL REGISTRATION NUMBER: NL8746.

Control in the Hospital by Extensive Clinical rules for Unplanned hospitalizations in older Patients (CHECkUP); study design of a multicentre randomized study.

BACKGROUND: Due to ageing of the population the incidence of multimorbidity and polypharmacy is rising. Polypharmacy is a risk factor for medication-related (re)admission and therefore places a significant burden on the healthcare system. The reported incidence of medication-related (re)admissions varies widely due to the lack of a clear definition. Some medications are known to increase the risk for medication-related admission and are therefore published in the triggerlist of the Dutch guideline for Polypharmacy in older patients. Different interventions to support medication optimization have been studied to reduce medication-related (re)admissions. However, the optimal template of medication optimization is still unknown, which contributes to the large heterogeneity of their effect on hospital readmissions. Therefore, we implemented a clinical decision support system (CDSS) to optimize medication lists and investigate whether continuous use of a CDSS reduces the number of hospital readmissions in older patients, who previously have had an unplanned probably medication-related hospitalization. METHODS: The CHECkUP study is a multicentre randomized study in older (≥60 years) patients with an unplanned hospitalization, polypharmacy (≥5 medications) and using at least two medications from the triggerlist, from Zuyderland Medical Centre and Maastricht University Medical Centre+ in the Netherlands. Patients will be randomized. The intervention consists of continuous (weekly) use of a CDSS, which generates a Medication Optimization Profile, which will be sent to the patient's general practitioner and pharmacist. The control group will receive standard care. The primary outcome is hospital readmission within 1 year after study inclusion. Secondary outcomes are one-year mortality, number of emergency department visits, nursing home admissions, time to hospital readmissions and we will evaluate the quality of life and socio-economic status. DISCUSSION: This study is expected to add evidence on the knowledge of medication optimization and whether use of a continuous CDSS ameliorates the risk of adverse outcomes in older patients, already at an increased risk of medication-related (re)admission. To our knowledge, this is the first large study, providing one-year follow-up data and reporting not only on quality of care indicators, but also on quality-of-life. TRIAL REGISTRATION: The trial was registered in the Netherlands Trial Register on October 14, 2018, identifier: NL7449 (NTR7691). https://www.trialregister.nl/trial/7449 .

The impact of donor type on resource utilisation and costs in allogeneic haematopoietic stem cell transplantation in the Netherlands.

BACKGROUND: Allogeneic haematopoietic stem cell transplantation (HSCT) is increasingly used, but this treatment is complex and costly. As clinical outcomes of HSCT with matched unrelated donor (MUD) and haploidentical donors are similar, costs could influence donor choice. METHOD: We retrospectively compared resource utilisation and costs of HSCT using the three different donor types (matched related donor (MRD) (n = 32), haploidentical related (n = 30) and MUD (n = 60)) within the first year after transplantation. Costs were analysed through a bottom-up method. Non-parametric bootstrapping was applied to test for statistical differences in costs. Subgroup analyses were performed to identify predictors for costs. RESULTS: Cost pre-transplant for search and acquisition of the graft were significantly higher in MUD HSCT (€35 222) versus MRD and haploidentical HSCT (€15 356 and €16 097 respectively). The costs of haploidentical HSCT were the highest in the transplant phase. Main cost factors were inpatient days and medication. Overall, the costs for haploidentical and MUD HSCT were similar (€115 724 for MUD, €113 312 for haploidentical). CONCLUSION: Our study suggests no difference in total transplantation costs between allogeneic HSCT using a MUD or a haploidentical donor. Since clinical outcomes seem similar as well, the choice of donor type might be based on availability, speed and logistics.

The burden of colorectal cancer survivors in the Netherlands: costs, utilities, and associated patient characteristics.

PURPOSE: The aim of this study is to assess the societal burden of colorectal cancer (CRC) survivorship 2-10 years post-diagnosis in terms of (1) societal costs, and (2) quality of life/utilities, and to analyze associated patient characteristics. METHODS: This is a cross-sectional, bottom-up prevalence-based burden of disease study, conducted from a societal perspective in the Netherlands. In total, 155 CRC survivors were included. Utilities were measured by the EQ-5D-5L, using the Dutch tariffs. A cost questionnaire was developed to obtain cost information. Subgroup analyses were performed, based on patient characteristics and sensitivity analyses. RESULTS: Of all CRC survivors, 81(54%) reported no problems for mobility, 133(88%) for self-care, 98(65%) for daily activities, 59(39%) for pain/discomfort, and 112(74%) for anxiety/depression on the EQ-5D-5L. The average EQ-5D-5L utility score was 0.82 (SD = 0.2) on a scale from 0 (death) to 1 (perfect health). Significant differences in utility score were found for gender, tumor stage, number of comorbidities, and lifestyle score. The average societal costs per CRC survivor per 6 months were estimated at €971 (min = €0, max = €32,425). Significant differences in costs were found for the number of comorbidities. CONCLUSIONS: This study shows a considerable burden of CRC survivors 2-10 years after diagnosis, in comparison with survivors sooner after diagnosis and with healthy individuals in the Netherlands. IMPLICATIONS FOR CANCER SURVIVORS: Long-term care of CRC survivors should focus on improving the societal burden by identifying modifiable factors, as summarized in the WCRF/AICR lifestyle score, including body composition, physical activity, and diet.

Evidence-based recommendations for economic evaluations in spine surgery: study protocol for a Delphi consensus.

INTRODUCTION: Considering the rising global healthcare expenses, economic evaluations are more important than ever. Even though the number of studies regarding costs and cost-effectiveness is increasing, the quality of these studies remains relatively low. This is mainly caused by abundant heterogeneity in methods used for determining, calculating and reporting cost data, despite current general guidelines for the conduct of economic evaluations. Disease-specific recommendations for the conduct of economic evaluations in the field of spine surgery, as complement to existing general guidelines, will ameliorate overall research quality, comparability and interpretability and thus, the overall quality. We aim to provide expert-based recommendations for the design, conduct, and reporting of economic evaluations in spine surgery. METHODS AND ANALYSIS: A modified Delphi study will be conducted to formulate expert-based recommendations. The following steps will be taken:(1) The conduct of a systematic review to identify relevant publications and identify relevant authors. Formation of an expert group and a Delphi-panel. (2) Drafting of statements based on articles included in the systematic literature review. Validation of drafted statements by the expert group. Step 2 can be repeated up to three times, statements can be discarded and adjusted in these rounds. Statements with more than 75% agreement will be accepted as consensus statements. (3) Validation of statements by the Delphi-panel. (4) Final recommendations. ETHICS AND DISSEMINATION: The underlying work is based on existing literature and published data and does not include participation of patients, and thus does not require ethical review approval. The final recommendations are intended for (clinical) researchers in the field of cost-effectiveness in spine surgery. The Delphi method ensures that the final output reflects the opinions of international participants and gives insight in the adherence level to the recommendations. The aim is to reach uniformity in design, conduct and reporting of these studies, as is currently lacking. This will provide a solid basis to determine cost-effectiveness of spine surgeries and consequently aid to limit the rising healthcare costs. The findings of this study and the final recommendations will be disseminated in conferences and seminars and will be published in an international peer-reviewed journal.

Lisfranc injuries: fix or fuse? : a systematic review and meta-analysis of current literature presenting outcome after surgical treatment for Lisfranc injuries.

AIMS: This systematic review and meta-analysis was conducted to compare open reduction and internal fixation (ORIF) with primary arthrodesis (PA) in the treatment of Lisfranc injuries, regarding patient-reported outcome measures (PROMs), and risk of secondary surgery. The aim was to conclusively determine the best available treatment based on the most complete and recent evidence available. METHODS: A systematic search was conducted in PubMed, Cochrane Controlled Register of Trials (CENTRAL), EMBASE, CINAHL, PEDro, and SPORTDiscus. Additionally, ongoing trial registers and reference lists of included articles were screened. Risk of bias (RoB) and level of evidence were assessed using the Cochrane risk of bias tools and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool. The random and fixed-effect models were used for the statistical analysis. RESULTS: A total of 20 studies were selected for this review, of which 12 were comparative studies fit for meta-analysis, including three randomized controlled trials (RCTs). This resulted in a total analyzed population of 392 patients treated with ORIF and 249 patients treated with PA. The mean differences between the two groups in American Orthopedic Foot and Ankle Society (AOFAS), VAS, and SF-36 scores were -7.41 (95% confidence interval (CI) -13.31 to -1.51), 0.77 (95% CI -0.85 to 2.39), and -1.20 (95% CI -3.86 to 1.46), respectively. CONCLUSION: This is the first study to find a statistically significant difference in PROMs, as measured by the AOFAS score, in favour of PA for the treatment of Lisfranc injuries. However, this difference may not be clinically relevant, and therefore drawing a definitive conclusion requires confirmation by a large prospective high-quality RCT. Such a study should also assess cost-effectiveness, as cost considerations might be decisive in decision-making. Level of Evidence: I Cite this article: Bone Jt Open 2021;2(10):842-849.

Comparison of (Partial) economic evaluations of transforaminal lumbar interbody fusion (TLIF) versus Posterior lumbar interbody fusion (PLIF) in adults with lumbar spondylolisthesis: A systematic review.

INTRODUCTION: The demand for spinal fusion surgery has increased over the last decades. Health care providers should take costs and cost-effectiveness of these surgeries into account. Open transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) are two widely used techniques for spinal fusion. Earlier research revealed that TLIF is associated with less blood loss, shorter surgical time and sometimes shorter length of hospital stay, while effectiveness of both techniques on back and/or leg pain are equal. Therefore, TLIF could result in lower costs and be more cost-effective than PLIF. This is the first systematic review comparing direct and indirect (partial) economic evaluations of TLIF with PLIF in adults with lumbar spondylolisthesis. Furthermore, methodological quality of included studies was assessed. METHODS: Searches were conducted in eight databases for reporting on eligibility criteria; TLIF or PLIF, lumbar spondylolisthesis or lumbar instability, and cost. Costs were converted to United States Dollars with reference year 2020. Study quality was assessed using the bias assessment tool of the Cochrane Handbook for Systematic Reviews of Interventions, the Level of Evidence guidelines of the Oxford Centre for Evidence-based Medicine and the Consensus Health Economic Criteria (CHEC) list. RESULTS: Of a total of 693 studies, 16 studies were included. Comparison of TLIF and PLIF could only be made indirectly, since no study compared TLIF and PLIF directly. There was a large heterogeneity in health care and societal perspective costs due to different in-, and exclusion criteria, baseline characteristics and the use of costs or charges in calculations. Health care perspective costs, calculated with hospital costs, ranged from $15,867-$43,217 in TLIF-studies and $32,662 in one PLIF-study. Calculated with hospital charges, it ranged from $8,964-$51,469 in TLIF-studies and $21,838-$93,609 in two PLIF-studies. Societal perspective costs and cost-effectiveness, only mentioned in TLIF-studies, ranged from $5,702/QALY-$48,538/QALY and $50,092/QALY-$90,977/QALY, respectively. Overall quality of studies was low. CONCLUSIONS: This systematic review shows that TLIF and PLIF are expensive techniques. Moreover, firm conclusions about the preferable technique, based on (partial) economic evaluations, cannot be drawn due to limited studies and heterogeneity. Randomized prospective trials and full economical evaluations with direct TLIF and PLIF comparison are needed to obtain high levels of evidence. Furthermore, development of guidelines to perform adequate economic evaluations, specified for the field of interest, will be useful to minimize heterogeneity and maximize transferability of results. TRIAL REGISTRATION: Prospero-database registration number: CRD42020196869.

Cost-effectiveness of open transforaminal lumbar interbody fusion (OTLIF) versus minimally invasive transforaminal lumbar interbody fusion (MITLIF): a systematic review and meta-analysis.

BACKGROUND CONTEXT: The number of performed instrumented lumbar spine surgeries and associated health-care-related costs has increased over the last decades, and will increase further in the future. With the consistent growth of health-care-related costs, cost-effectiveness of surgical techniques is of major relevance. Common indications for instrumented lumbar spine surgery are spondylolisthesis and degenerative disease. A commonly used technique is the open transforaminal lumbar interbody fusion (OTLIF). Nowadays, there is an increasing interest in the minimally invasive variation of this technique (minimally invasive transforaminal lumbar interbody fusion [MITLIF]). Currently available literature describes that MITLIF has comparable or even better clinical results compared to OTLIF. Cost-effectiveness of MITLIF and OTLIF is important considering the growing health-care related costs, although no consensus has been reached regarding the most cost-effective technique. In this systematic review, previous literature concerning costs and cost-effectiveness of OTLIF was compared with MITLIF in patients with lumbar spondylolisthesis or degenerative disease. Furthermore, methodological quality of included studies was assessed. PURPOSE: This study aims to evaluate the current literature on cost-effectiveness of OTLIF compared MITLIF to in patients with lumbar spondylolisthesis or degenerative disease. STUDY DESIGN: This study is a systematic literature review and meta-analysis. STUDY SAMPLE: Clinical studies reporting costs or cost-effectiveness for either OTLIF or MITLIF in patients with spondylolisthesis, lumbar instability, or degenerative disease were included. OUTCOME MEASURES: The following data items were evaluated: study design, study population, utility measurement tool, gained quality adjusted life years (QALYs), cost sources, health care and societal perspective costs, total costs, costs per QALY (cost-effectiveness) and incremental cost-effectiveness ratio (ICER). METHODS: A systematic search was conducted using databases PubMed, CINAHL, EMBASE, Cochrane, Clinical Trials, Current Controlled Trials, ClinicalTrials.gov, NHS Centre for Review and Dissemination, Econlit and Web of Science on studies reporting OTLIF or MITLIF, spondylolisthesis or lumbar instability or degenerative disease, and costs. Relevant studies were selected and reviewed independently by two authors. For comparison, all costs were converted to American dollars with the reference year 2018. RESULTS: After duplicate removal, a total of 892 studies were identified. Eventually, 32 studies were included. Nine studies compared OTLIF and MITLIF directly. All studies mentioned health care perspective costs. Seven studies mentioned societal perspective costs. Cost-effectiveness of OTLIF was mentioned in five studies, ranging from $47,303/QALY to $218,766/QALY. Cost-effectiveness of MITLIF was mentioned in one study, $121,105/QALY. Meta-analysis of hospital perspective costs showed a significant overall effect in favor of MITLIF, with a mean difference of $2,650. There was great heterogeneity in health care and societal perspective costs due to different in-, and exclusion factors, baseline characteristics, and calculation methods. Overall quality of studies was low. CONCLUSIONS: OTLIF and MITLIF appear to be expensive interventions when using a threshold of $50,000/QALY. Results of this study and previous literature suggest that MITLIF is more cost-effective compared to OTLIF. Considering the increase in health care costs of instrumented spine surgery, cost-effectiveness could be one of the factors in surgical decision-making. Prospective randomized studies directly comparing cost-effectiveness of OTLIF and MITLIF from both hospital and societal perspectives are needed to obtain higher level of evidence.

Effect of direct oral feeding following minimally invasive esophagectomy on costs and quality of life.

AIMS: Following (minimally invasive) esophagectomy, patients often rely on tube feeding, since oral intake is often delayed. Consequently, additional support by a dietician and home care is needed until oral intake is commenced. In this study, the effects of direct start of oral feeding compared with tube feeding following an esophagectomy was evaluated on treatment costs and health-related quality of life (QoL). METHODS: Patients undergoing a minimally invasive esophagectomy were randomized in the NUTRIENT II study between controls (nil-per-mouth during 5 days and subsequent tube feeding) and a group in whom oral feeding was started directly postoperatively. Total hospital costs (including readmission and outpatient costs) and home care data for a period of 6 months after surgery were analyzed. QoL (measured using EORTC-QLQ-C30 and EORTC OG-25) was assessed preoperatively and 6 weeks, 12 weeks, and 6 months postoperatively. RESULTS: A total 132 patients were included (n = 65 direct oral feeding group and n = 67 control group). Mean patient hospital costs were €26,014 in the intervention group over a 6-month period compared to €26,989 in the control group (p = .825). Furthermore, people with direct oral feeding required significantly less home care assistance; i.e. 23 (48.9%) intervention patients versus 37 (77.1%) control patients (p = .004). Also, QoL in patients with direct oral feeding progressed more quickly when compared to the control group. LIMITATIONS: Hospital costs were derived from a single hospital unit whereas costs from all the participating units may be a better reflection of the cost deviation. Availability of homecare data was limited, leading to difficulty in detecting differences in costs. CONCLUSION: This study suggests that direct oral feeding leads to similar total costs and a significantly reduced need for home care assistance. Furthermore, QoL in intervention group increased more quickly when compared to the control group.

The clinical and economical impact of postoperative ileus in patients undergoing colorectal surgery.

BACKGROUND: Colorectal surgery is associated with postoperative ileus (POI). Despite its widespread manifestation, the influence of POI on recovery, quality of life (QoL), and costs is largely unknown. The aim of this study was to assess whether the inflammatory processes found in experimental studies are also evident in patients undergoing colorectal surgery. In addition, the impact of POI on short and long-term QoL and costs was investigated. METHODS: We analyzed the outcomes of the SANICS-II trial, including prospective evaluation of inflammatory parameters in blood samples, costs from a societal perspective and QoL, using validated questionnaires. Outcomes were compared between patients with and without POI, and in particular patients with POI as unique complication. KEY RESULTS: A total of 265 patients (POI, n = 66 vs non-POI, n = 199) were included and 38/66 had POI as only complication. CRP levels were significantly increased on postoperative day (POD) 1, 2, 3, and 4 in patients with POI. Furthermore, plasma levels of cytokines IL-6, Il-8 and IL-10 were significantly increased the first 2 days after resection. Patients with POI had a higher overall complication rate and a reduced QoL 3 months postoperatively, even in the only POI group. Moreover, mean societal cost per patient with POI was 38%-47% higher at 3 months postoperatively. CONCLUSIONS & INFERENCES: Supporting findings from experimental studies, inflammatory parameters were increased in patients with only POI and comparable with all patients with POI. These results demonstrate the impact and large contribution of POI in postoperative inflammation, costs and QoL in patients undergoing colorectal surgery.

Cost-effectiveness and cost-utility analysis of a work-place smoking cessation intervention with and without financial incentives.

AIMS: To perform an economic evaluation of a work-place smoking cessation group training programme with incentives compared with a training programme without incentives. DESIGN: A trial-based cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) from a societal perspective and an employer's perspective. SETTING: Sixty-one companies in the Netherlands. PARTICIPANTS: A total of 604 tobacco-smoking employees. INTERVENTION AND COMPARATOR: A 7-week work-place smoking cessation group training programme. The intervention group earned gift vouchers of €350 for 12 months' continuous abstinence. The comparator group received no incentives. MEASUREMENTS: Online questionnaires were administered to assess quality of life (EQ-5D-5 L) and resource use during the 14-month follow-up period (2-month training period plus 12-month abstinence period). For the CEA the primary outcome measure was carbon monoxide (CO)-validated continuous abstinence; for the CUA the primary outcome was quality-adjusted life years (QALY). Bootstrapping and sensitivity analyses were performed to account for uncertainty. Incremental cost-effectiveness ratio (ICER) tables were used to determine cost-effectiveness from a life-time perspective. FINDINGS: Of the participants in the intervention group, 41.1% had quit smoking compared with 26.4% in the control group. From a societal perspective with a 14-month follow-up period, the ICER per quitter for an intervention with financial incentives compared with no incentives was €11 546. From an employer's perspective, the ICER was €5686. There was no significant difference in QALYs between the intervention and control group within the 14-month follow-up period. The intervention was dominated by the comparator in the primary analysis at a threshold of €20 000 per QALY. In the sensitivity analysis, these results were uncertain. A life-time perspective showed an ICER of €1249 (95% confidence interval = €850-2387) per QALY. CONCLUSIONS: Financial incentives may be cost-effective in increasing quitting smoking, particularly from a life-time perspective.

An economic evaluation of a computer-tailored e-learning program to promote smoking cessation counseling guideline adherence among practice nurses.

OBJECTIVE: To conduct an economic evaluation of a tailored e-learning program, which successfully improved practice nurses' smoking cessation guideline adherence. METHODS: The economic evaluation was embedded in a randomized controlled trial, in which 269 practice nurses recruited 388 smoking patients. Cost-effectiveness was assessed using guideline adherence as effect measure on practice nurse level, and continued smoking abstinence on patient level. Cost-utility was assessed on patient level, using patients' Quality Adjusted Life Years (QALYs) as effect measure. RESULTS: The e-learning program was likely to be cost-effective on practice nurse level, as adherence to an additional guideline step cost €1,586. On patient level, cost-effectiveness was slightly likely after six months (cost per additional quitter: €7,126), but not after twelve months. The cost-utility analysis revealed slight cost-effectiveness (cost per QALY gained: €18,431) on patient level. CONCLUSION: Providing practice nurses with a tailored e-learning program is cost-effective to improve their smoking cessation counseling. Though, cost-effectiveness on patient level was not found after twelve months, potentially resulting from smoking relapse. PRACTICE IMPLICATIONS: Widespread implementation of the e-learning program can improve the quality of smoking cessation care in general practice. Strategies to prevent patients' smoking relapse should be further explored to improve patients' long-term abstinence.