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).

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.

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 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.

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.

Evidence-informed vaccine decision making: The introduction of Human Papilloma Virus (HPV) vaccination in the Netherlands.

Little is known about the role of (economic) information or evidence in the different stages of the decision-making process on vaccine introduction. By conducting a document analysis on the public decision-making process of introducing human Papilloma virus (HPV) vaccine into the national vaccination program (NVP) in the Netherlands, we aim to gain insight into which information plays a role during the introduction of a vaccination programme. A document analysis was performed on the public decision-making process regarding the introduction of HPV vaccine into the NVP in the Netherlands. Information used or asked for by various stakeholders during different stages of the policymaking process was identified. In total, 42 documents were found, analyzed and synthesized, for the period between August 2006 and September 2009. Documents were analyzed using directed content analysis based on eight broad categories of criteria used in decision-making frameworks for introducing a vaccine. Our analysis demonstrates that a wide variety of stakeholders is involved in the process. Financial or economic issues were stipulated in 64.3% of the documents and information on vaccine characteristics were discussed in 59.5%. Economic information from economic evaluations was discussed most (47.6%). Based on our analysis, it can be concluded that economic information, in particular information from economic evaluations, played an important role in the decision-making process regarding the introduction of HPV-vaccination.

A discrete choice experiment to investigate patient preferences for HIV testing programs in Bogotá, Colombia.

BACKGROUND: To assess patients' preferences for HIV testing in Colombia. METHODS: A discrete choice experiment was used to assess preferences of patients diagnosed with HIV, for HIV testing in two HIV clinics in Bogotá, Colombia. Patients were asked to choose repeatedly between two hypothetical HIV testing options that varied with respect to five attributes: distance to testing site, confidentiality, testing days, sample collection method, and the services if HIV positive. A random parameter model was used to analyze the data. RESULTS: A total of 249 questionnaires were eligible for data analysis. Respondents showed a preference for testing on weekdays, nobody being aware, a sample taken from the arm, and receiving medications through a referral. The respondents showed a high negative preference for many people being aware, followed by testing during the weekend and home testing. Subgroup analyses by gender and prior testing history did not reveal significant differences. CONCLUSION: This study suggests that patients' preferences for HIV testing focused especially on confidentiality, availability during weekdays, and using a sample from the arm. This information could be useful to improve uptake of HIV testing in Bogotá, Colombia.

An economic evaluation of perioperative enteral nutrition in patients undergoing colorectal surgery (SANICS II study).

AIMS: The objective of this (trial based) economic evaluation was to assess, from a societal perspective, the cost-effectiveness of perioperative enteral nutrition compared with standard care in patients undergoing colorectal surgery. MATERIALS AND METHODS: Alongside the SANICS II randomized controlled trial, global quality-of-life, utilities (measured by EQ-5D-5L), healthcare costs, production losses, and patient and family costs were assessed at baseline, 3 months, and 6 months. Incremental cost-effectiveness ratios (ICERs) (i.e. cost per increased global quality-of-life score or quality-adjusted life year [QALY] gained) and cost effectiveness acceptability curves were visualized. RESULTS: In total, 265 patients were included in the original trial (n = 132 in the perioperative enteral nutrition group and n = 133 in the standard care group). At 6 months, global quality-of-life (83 vs 83, p = .357) did not differ significantly between the groups. The mean total societal costs for the intervention and standard care groups were €14,673 and €11,974, respectively, but did not reach statistical significance (p = .109). The intervention resulted in an ICER of -€6,276 per point increase in the global quality of life score. The gain in QALY was marginal (0.003), with an additional cost of €2,941, and the ICUR (Incremental cost utility ratio) was estimated at €980,333. LIMITATIONS: The cost elements for all the participating centers reflect the reference prices from the Netherlands. Patient-reported questionnaires may have resulted in recall bias. Sample size was limited by exclusion of patients who did not complete questionnaires for at least at two time points. A power analysis based on costs and health-related quality-of-life (HRQoL) was not performed. The economic impact could not be analyzed at 1 month post-operatively where the effects could potentially be higher. CONCLUSIONS: This study suggests that perioperative nutrition is not beneficial for the patients in terms of quality-of-life and is not cost-effective.

A systematic review on economic evaluations of school-based lifestyle interventions targeting weight-related behaviours among 4-12 year olds: Issues and ways forward.

Current guidelines for economic evaluations do not provide specific recommendations for the evaluation of school-based lifestyle interventions. This study examined and discussed the key aspects in the design of economic evaluations on school-based interventions targeting weight-related behaviours among 4-12 year olds. The PubMed and CRD databases (NHS EED) were searched. Grey literature was identified from reference lists and websites of relevant organizations. Full economic evaluations on school-based interventions targeting physical activity, sedentariness, or diet were selected. Key aspects included the objective, audience, intervention, comparator, population, type of analysis, perspective, costs, outcomes, and time horizon. Information was also extracted on measuring and valuing costs and outcomes, linking and extrapolating outcomes, and the maintenance of intervention effects. The 23 included studies reported on cost-effectiveness (CEAs) (N = 12), cost-utility (CUAs) (N = 9), social cost benefit (SCBA) (N = 2), and social return on investment (SROI) (N = 1) analysis. The usual practice comparator was generally not clearly defined. The SROI analysis was the single study that included outcomes in other persons than the child. Healthcare costs (N = 14), productivity costs (N = 4), and costs to the household (N = 3), or education (N = 2) sector were examined. The outcome in trial-based CEAs consisted of a variety of weight-related measures. Seven distinctive models were used to extrapolate health and/or productivity costs. To enhance the usefulness of economic evaluations on school-based lifestyle interventions in allocating public health budgets, transparent reporting on key aspects, broadening the scope of economic evaluations, and standardizing the measurement, valuation, and extrapolation of costs and outcomes should be improved. This study was conducted in Maastricht, the Netherlands.

Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multicenter comparative cohort study.

BACKGROUND: The standard aftercare treatment in surgically treated trauma patients with fractures around or in a joint, known as (peri)- or intra-articular fractures of the lower extremities, is either non-weight bearing or partial weight bearing. We have developed an early permissive weight bearing post-surgery rehabilitation protocol in surgically treated patients with fractures of the lower extremities. In this proposal we want to compare our early permissive weight bearing protocol to the existing current non-weight bearing guidelines in a prospective comparative cohort study. METHODS/DESIGN: The study is a prospective multicenter comparative cohort study in which two rehabilitation aftercare treatments will be contrasted, i.e. permissive weight bearing and non-weight bearing according to the AO-guideline. The study population consists of patients with a surgically treated fracture of the pelvis/acetabulum or a surgically treated (peri)- or intra-articular fracture of the lower extremities. The inclusion period is 12 months. The duration of follow up is 6 months, with measurements taken at baseline, 2,6,12 and 26 weeks post-surgery. PRIMARY OUTCOME MEASURE: ADL with Lower Extremity Functional Scale. Outcome variables for compliance, as measured with an insole pressure measurement system, encompass peak load and step duration. DISCUSSION: This study will investigate the (cost-) effectiveness of a permissive weight bearing aftercare protocol. The results will provide evidence whether a permissive weight bearing protocol is more effective than the current non-weight bearing protocol. TRIAL REGISTRATION: The study is registered in the Dutch Trial Register ( NTR6077 ). Date of registration: 01-09-2016.

OPTIMIZING USABILITY OF AN ECONOMIC DECISION SUPPORT TOOL: PROTOTYPE OF THE EQUIPT TOOL.

OBJECTIVES: Economic decision-support tools can provide valuable information for tobacco control stakeholders, but their usability may impact the adoption of such tools. This study aims to illustrate a mixed-method usability evaluation of an economic decision-support tool for tobacco control, using the EQUIPT ROI tool prototype as a case study. METHODS: A cross-sectional mixed methods design was used, including a heuristic evaluation, a thinking aloud approach, and a questionnaire testing and exploring the usability of the Return of Investment tool. RESULTS: A total of sixty-six users evaluated the tool (thinking aloud) and completed the questionnaire. For the heuristic evaluation, four experts evaluated the interface. In total twenty-one percent of the respondents perceived good usability. A total of 118 usability problems were identified, from which twenty-six problems were categorized as most severe, indicating high priority to fix them before implementation. CONCLUSIONS: Combining user-based and expert-based evaluation methods is recommended as these were shown to identify unique usability problems. The evaluation provides input to optimize usability of a decision-support tool, and may serve as a vantage point for other developers to conduct usability evaluations to refine similar tools before wide-scale implementation. Such studies could reduce implementation gaps by optimizing usability, enhancing in turn the research impact of such interventions.

Health-related quality of life and cost-effectiveness analysis of gum chewing in patients undergoing colorectal surgery: results of a randomized controlled trial.

BACKGROUND: Postoperative ileus (POI) and anastomotic leakage (AL) following colorectal surgery severely increase healthcare costs and decrease quality of life. This study evaluates the effects of reducing POI and AL via perioperative gum chewing compared to placebo (control) on in-hospital costs, health-related quality of life (HRQoL), and assesses cost-effectiveness. METHODS: In patients undergoing elective, open colorectal surgery, changes in HRQoL were assessed using EORTC-QLQ-C30 questionnaires and costs were estimated from a hospital perspective. Incremental cost-effectiveness ratios were estimated. RESULTS: In 112 patients, mean costs for ward stay were significantly lower in the gum chewing group when compared to control (€3522 (95% CI €3034-€4010) versus €4893 (95% CI €3843-€5942), respectively, p = .020). No differences were observed in mean overall in-hospital costs, or in mean change in any of the HRQoL scores or utilities. Gum chewing was dominant (less costly and more effective) compared to the control in more than 50% of the simulations for both POI and AL. CONCLUSION: Reducing POI and AL via gum chewing reduced costs for ward stay, but did not affect overall in-hospital costs, HRQoL, or mapped utilities. More studies with adequate sample sizes using validated questionnaires at standardized time points are needed.

Is it cost-effective to provide internet-based interventions to complement the current provision of smoking cessation services in the Netherlands? An analysis based on the EQUIPTMOD.

BACKGROUND AND AIM: The cost-effectiveness of internet-based smoking cessation interventions is difficult to determine when they are provided as a complement to current smoking cessation services. The aim of this study was to evaluate the cost-effectiveness of such an alternate package compared with existing smoking cessation services alone (current package). METHODS: A literature search was conducted to identify internet-based smoking cessation interventions in the Netherlands. A meta-analysis was then performed to determine the pooled effectiveness of a (web-based) computer-tailored intervention. The mean cost of implementing internet based interventions was calculated using available information, while intervention reach was sourced from an English study. We used EQUIPTMOD, a Markov-based state-transition model, to calculate the incremental cost-effectiveness ratios [expressed as cost per quality-adjusted life years (QALYs) gained] for different time horizons to assess the value of providing internet-based interventions to complement the current package.). Deterministic sensitivity analyses tested the uncertainty around intervention costs per smoker, relative risks, and the intervention reach. RESULTS: Internet-based interventions had an estimated pooled relative risk of 1.40; average costs per smoker of €2.71; and a reach of 0.41% of all smokers. The alternate package (i.e. provision of internet-based intervention to the current package) was dominant (cost-saving) compared with the current package alone (0.14 QALY gained per 1000 smokers; reduced health-care costs of €602.91 per 1000 smokers for the life-time horizon). The alternate package remained dominant in all sensitivity analyses. CONCLUSION: Providing internet-based smoking cessation interventions to complement the current provision of smoking cessation services could be a cost-saving policy option in the Netherlands.