Facilitators and barriers to the transition from outpatient clinic visits to home-based check-ups for children being treated with growth hormone: a mixed-methods study.

Although the coronavirus disease 2019 (COVID-19) pandemic accelerated the adoption and expansion of telemedicine worldwide, little is known about the transition to home-based care for children. This study aims to investigate the facilitators and barriers to the transition from outpatient clinic visits to home-based check-ups (HBCU), for children being treated with growth hormone. A mixed-methods study was performed at Amalia Children's Hospital (Radboud University Medical Centre, Nijmegen), consisting of questionnaires and semi-structured and focus group interviews. For the quantitative part, the Measurement Instrument for Determinants of Innovation (MIDI) was utilised to investigate the facilitators and barriers for the 81 participants regarding the transition to HBCU. The MIDI questionnaire is comprised of four domains: the innovation-, user-, organisation-, and the socio-political scale. Descriptive statistics were performed for analysing the questionnaires. For the qualitative part, interviews with 10 participants derived from the questionnaire and the two focus group interviews were conducted, to gain more in-depth information about the research topic, until data saturation was reached. The interviews were analysed by using the reflective thematic approach, starting with deductive coding and followed by inductive coding. Several facilitators were recognised in our study: procedural clarity, self-efficacy, convenience, patient-centred care, increased accuracy in height measurements, social support, client/patient satisfaction/cooperation, patient-centred care, the flexibility and adaptivity of HBCU, physical start-up period of HBCU, and a potential decrease in healthcare costs. However, several barriers were also noted in our study: poor compatibility with current practice, lack of consultation within the team, feeling of being less controlled by physicians, unsettledness of the organisation, an increased workload for the staff, and insufficient information communication technology (ICT) facilities. CONCLUSION: This study revealed that HBCU have considerable benefits for both patients and healthcare professionals, from the standpoint of innovation, user, and socio-political points of view. The identified facilitators and barriers to HBCU should be taken into account when further steps of implementing HBCU are considered. WHAT IS KNOWN: • The Corona-Virus-Disease 2019 (COVID-19) pandemic has had an immense impact on health care worldwide. A substantial amount of the outpatient clinic visits for children treated with growth hormone was, as a result of the pandemic, transferred to online consultation. Transitioning paediatric growth hormone treatment to the home setting may be favorable for children and their parents/caregivers) as well for healthcare professionals. • Insights regarding facilitators and barriers is vital for the successful implementation and adoption of home-care technologies. WHAT IS NEW: • To our knowledge, we are first to report on and explicit the facilitators and barriers of the transition to home-based check-ups, via online consultation for children being treated with growth hormone. • Both children and healthcare professionals reported major facilitators and some minor barriers to the transition to home-based check-ups, illustrating their potential value. These facilitators and barriers should be considered while working towards implementation of home-based check-ups.

Parental measurement of height in growth hormone-treated children in the hospital setting proves valid: an observational study - potential for replacement of outpatient clinic visits to the home setting.

Reliable height measurement plays a pivotal role in evaluating the efficacy of costly growth hormone (GH) therapy in children. Currently, regularly outpatient clinic visits are needed to accurately measure height. The outpatient clinic visits are time-consuming for parents as well for health care professionals. This observational study aimed to investigate the validity of parentally performed height measurements compared to height measurements in the outpatient setting. An observational study was performed at the outpatient clinic of Amalia's Children's Hospital Nijmegen. A portable stadiometer (PS) was developed for height measurements at home. Measurements with the PS were performed by the researcher (PSR) and parents/caregivers (PSP). Measurements performed with the electronic digital ruler (EDS) were considered as the gold standard. The parents were potentially unblinded for the gold standard measurement (EDS). Descriptive statistics, Wilcoxon signed-rank, and Pearson's correlation tests were performed. The Bland-Altman plots were made to illustrate the correlation of the PSR or PSP with the gold standard. The correlation between the height measurements with PSR or PSP compared to the EDS was substantial (PSR: r = 0.9998, R2 = 0.9996, P < 0.001; PSP: r = 0.9998, R2 = 0.9995, P < 0.001). However, a statistically significant underestimation of the PSR and PSP was observed (P < 0.001). The mean difference of the PSR and PSP was respectively - 0.21 cm ± 0.52 SD and - 0.30 cm ± 0.62 SD in comparison to the EDS. The Bland-Altman plots illustrated that 95% of the PSR measurements were between - 1.03 and 0.60 cm and 95% of the PSP measurements were between - 1.26 and 0.66 cm compared to the EDS. CONCLUSION: We found a strong correlation between the PSR or PSP and the EDS, with only a minor underestimation of approximately 0.2-0.3 cm. In our opinion, this underestimation is clinically irrelevant as it does not result in an adjustment in GH dose. To conclude, parental height measurements could be a promising tool as it partially replaces outpatient clinic visits needed for measurements of height. Further studies are required to confirm this statement. WHAT IS KNOWN: • The immense impact of the coronavirus disease 2019 (COVID-19) pandemic on health care has increased telemedicine worldwide. For adequate integration of telemedicine in paediatric growth hormone treatment, reliable height and weight measurements in the home setting are required. • Earlier studies have shown that parents are capable to reliable perform height measurements in healthy children. WHAT IS NEW: • To our knowledge, this is the first study to show a strong correlation between the height measurements with a portable stadiometer by parents and those made with the electronic digital ruler (gold standard) in children treated with growth hormone. There was only a minor underestimation of approximately 0.2-0.3 cm, which we anticipated to be clinically irrelevant. • Therefore, home height measurements can at least partly replace costly outpatient visits for children being treated with growth hormone as part of an uncomplicated course. Moreover, these results may also be promising for implementation in other paediatric populations besides children treated with growth hormone.

Resective Epilepsy Surgery, QUality of life and Economic evaluation (RESQUE): the change in quality of life after resective epilepsy surgery-protocol for a multicentre, prospective cohort study.

INTRODUCTION: Resective epilepsy surgery is often seen as a last resort when treating drug-resistant epilepsy. Positive results on quality of life (QoL) and economic benefits after surgery argue for a less restrictive attitude towards epilepsy surgery for drug-resistant epilepsy. QoL and economic benefits are country-dependent. The objective of the Resective Epilepsy Surgery, QUality of life and Economic evaluation (RESQUE) trial is to evaluate the change in QoL before and after epilepsy surgery in Dutch people with drug-resistant epilepsy. The results will form part of an economic evaluation of epilepsy surgery in people with epilepsy (PWE) in The Netherlands. METHODS AND ANALYSIS: A longitudinal prospective multicentre cohort study involving 100 PWE undergoing epilepsy surgery between 2019 and 2025 is being performed in three Dutch academic hospitals. Excluded are PWE who have a lower level of intelligence (TIQ<70) or who do not master the Dutch language. Before surgery and 3, 6, 12 and 24 months after surgery, PWE receive validated online questionnaires (QOLIE-31, EQ-5D, iMCQ and iPCQ) on QoL, cost of care, expectations and satisfaction. Primary outcome is the change in QoL. Secondary outcomes are change in generic QoL, seizure reduction (International League Against Epilepsy Outcome Classification), medical consumption, productivity, the correlation between QoL and seizure reduction and expectation of and satisfaction with the surgery. ETHICS AND DISSEMINATION: The study design has been approved by the Medical Ethics Review Committee (METC) of Maastricht UMC+ (2019-1134) and the Amsterdam UMC (vu). At the time of writing, UMC Utrecht is in the process of considering approval. The study will be conducted according to the Dutch Medical Research Involving Human Subjects Act and the Declaration of Helsinki. The results will be publicly disclosed and submitted for publication in international peer-reviewed scientific journals. There is no veto on publication by the involved parties. TRIAL REGISTRATION: NL8278; Pre-results.

@ease peer-to-peer youth walk-in centres in The Netherlands: A protocol for evaluating longitudinal outcomes, follow-up results and cost-of-illness.

AIM: Innovative youth mental health services around the globe vigorously work on increasing highly needed mental health care accessibility but their service users and care effectiveness have rarely been studied. The Dutch youth walk-in centres of @ease opened in 2018, with currently 11 locations at which free anonymous peer-to-peer counselling is offered to young people aged 12-25. The aim of this protocol is to outline the to-be-conducted research at @ease. METHODS: Three studies are outlined: (1) an outcome evaluation of @ease visits using hierarchical mixed model analyses and change calculations, (2) a cost-of-illness study using calculations for costs of truancy and care usage among these help-seeking young people, with regression analyses for risk group identification, and (3) a follow-up evaluation at three, six and 12 months to assess long-term effects after ending @ease visits. Data provided by young people include demographics, parental mental illness, truancy, past treatment, psychological distress (CORE-10) and health-related quality of life (EQ-5D-5L). Social and occupational functioning (SOFAS), suicidal ideation and need for referral are rated by the counsellors. Questionnaires are filled out at the end of every visit and at follow-up via e-mail or text, provided permission is given. DISCUSSION: Research regarding the visitors and effectiveness of the @ease services is fully original. It offers unique insights into the mental wellbeing and cost-of-illness of young people who may otherwise remain unseen while suffering from a high disease burden. The upcoming studies shed light on this unseen group, inform policy and practice and direct future research.

QUality of life and Economic evaluation after neuroSTimulation for Epilepsy (QUESTE) in adolescents and adults with drug-resistant epilepsy: protocol for a multicentre, prospective observational cohort study in The Netherlands.

INTRODUCTION: Epilepsy is one of the most common chronic neurological disorders. Antiseizure medication (ASM) is the first choice of treatment, however, 30% of epilepsy patients are drug-resistant. For these patients, neuromodulation can be an option, especially when epilepsy surgery is not possible or did not lead to seizure freedom. Epilepsy is associated with reduced quality of life (QoL), which heavily depends on seizure control.The most recent Cochrane reviews have shown that vagus nerve stimulation and deep brain stimulation of the anterior nucleus of the thalamus, lead to a responder rate OR of, respectively, 1.93 and 1.20. The question arises if neuromodulation for drug-resistant epilepsy (DRE) will be more cost-effective than sole treatment with ASM. The current study aims to determine the change in QoL after neuromodulation. Secondarily, we will aim to study the cost-effectiveness of these treatments. METHODS AND ANALYSIS: This prospective cohort study aims at including 100 patients aged 16 or above who will be referred for neuromodulation, from January 2021 to January 2026. After informed consent, QoL and other relevant parameters will be assessed at baseline, 6 months, 1, 2 and 5 years after surgery. Data on seizure frequency will be derived from patient charts. We expect that DRE patients will report better QoL after neuromodulation. Even if they would still report seizures, the treatment can be seen as useful. This is especially true when patients can participate in society again to a greater extent than before treatment. ETHICS AND DISSEMINATION: The board of directors of participating centres all gave permission for this study to commence. The medical ethics committees decided that this study does not fall under the Medical Research Involving Human Subjects Act (WMO). The findings of this study will be presented at (inter)national conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NL9033.

Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Protocol for a Cluster Randomized Trial and Trial-Based Economic Evaluation.

BACKGROUND: People with profound intellectual and multiple disabilities (PIMD) cannot communicate the need to change their incontinence products. The smart continence care (SCC) product Abena Nova signals caregivers when change is needed. This provides the opportunity for more person-centered care, increased quality of life, and a decreased number of leakages. However, there is a need for evidence of the effectiveness and cost-effectiveness of such technology compared with regular continence care (RCC) for people with PIMD. OBJECTIVE: This paper presents the research protocol for an effectiveness and cost-effectiveness study with people with PIMD living in long-term care facilities in the Netherlands. METHODS: A cluster randomized trial will be conducted in 3 consecutive waves across 6 long-term care providers for people with disabilities and 160 participants with PIMD. Long-term care providers are randomized at a 1:1 ratio, resulting in an intervention group and a group continuing RCC. The intervention group will receive implementation guidance and use SCC for 3 months; the other group will continue their RCC as usual and then switch to SCC. This study consists of three components: effectiveness study, economic evaluation, and process evaluation. The primary outcome will be a change in the number of leakages. The secondary outcomes are quality of life, the difference in the number of changes, the work perception of caregivers, cost-effectiveness, and cost utility. Data collection will occur at T0 (baseline), T1 (6 weeks), T2 (12 weeks), and T3 (9-month follow-up) for the first 2 intervention groups. An intention-to-treat analysis will be performed. The economic evaluation will be conducted alongside the trial from the societal and long-term care provider perspectives. Qualitative data collection through interviews and field notes will complement these quantitative results and provide input for the process evaluation. RESULTS: This research was funded in December 2019 by ZonMw, the Netherlands Organization for Health Research and Development. As of June 2022, we enrolled 118 of the 160 participants. The enrollment of participants will continue in the third and fourth quarters of 2022. CONCLUSIONS: This study will provide insights into the effectiveness and cost-effectiveness of SCC for people with PIMD, allowing long-term care providers to make informed decisions about implementing such a technology. This is the first time that such a large-scale study is being conducted for people with PIMD. TRIAL REGISTRATION: ClinicalTrials.gov NCT05481840; https://clinicaltrials.gov/ct2/show/NCT05481840. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42555.

Economic evaluation of nurse-led stroke aftercare addressing long-term psychosocial outcome: a comparison to care-as-usual.

OBJECTIVE: To examine the cost-effectiveness of nurse-led stroke aftercare addressing psychosocial outcome at 6 months post stroke, compared with care-as-usual. DESIGN: Economic evaluation within a comparative effectiveness research design. SETTING: Primary care (2016-2017) and community settings (2011-2013) in the Netherlands. PARTICIPANTS: Persons who suffered from ischaemic or haemorrhagic stroke, or a transient ischaemic attack and were discharged home after visiting the emergency department, hospitalisation or inpatient rehabilitation. INTERVENTIONS: Nurse-led stroke aftercare at 6 months post stroke addressing psychosocial functioning by providing screening, psycho-education, emotional support and referral to specialist care when needed. Care-as-usual concerned routine follow-up care including secondary prevention programmes and a consultation with the neurologist at 6 weeks post stroke. PRIMARY AND SECONDARY OUTCOME MEASURES: Main outcome measure of cost-effectiveness was quality-adjusted life years (QALYs) estimated by the quality of life measured by the five-dimensional, three-level EuroQol. Costs were assessed using a cost-questionnaire. Secondary outcomes were mood (Hospital Anxiety and Depression Scale) and social participation (Utrecht Scale for Evaluation of Rehabilitation-Participation) restrictions subscale. RESULTS: Health outcomes were significantly better in stroke aftercare for QALYs (Δ=0.05; 95% CI 0.01 to 0.09) and social participation (Δ=4.91; 95% CI 1.89 to 7.93) compared with care-as-usual. Total societal costs were €1208 higher in stroke aftercare than in care-as-usual (95% CI -€3881 to €6057). Healthcare costs were in total €1208 higher in stroke aftercare than in care-as-usual (95% CI -€3881 to €6057). Average costs of stroke aftercare were €91 (SD=€3.20) per person. Base case cost-effectiveness analyses showed an incremental cost-effectiveness ratio of €24 679 per QALY gained. Probability of stroke aftercare being cost-effective was 64% on a €50 000 willingness-to-pay level. CONCLUSIONS: Nurse-led stroke aftercare addressing psychosocial functioning showed to be a low-cost intervention and is likely to be a cost-effective addition to care-as-usual. It plays an important role by screening and addressing psychosocial problem, not covered by usual care.

A trial-based economic evaluation of the Restore4Stroke self-management intervention compared to an education-based intervention for stroke patients and their partners.

BACKGROUND: Since stroke survivors are increasingly responsible for managing stroke-related changes in their own health and lifestyle, self-management skills are required. In a recent randomised controlled trial a self-management intervention based on proactive coping action planning (SMI) in comparison with an education-based intervention (EDU) in stroke patients was investigated. However, no relevant treatment effects on the Utrecht Proactive Coping Competence scale (UPCC) and the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-Participation) were found. The current study is a trial-based economic evaluation from a societal perspective comparing the same interventions (SMI versus EDU). METHODS: UPCC, USER-Participation and EuroQol (EQ-5D-3 L) and costs were measured at baseline, three, six and twelve months after treatment. For the cost-effectiveness analyses, incremental cost effectiveness ratios (ICERs) were calculated for UPCC and USER-Participation. For the cost-utility analyses the incremental cost utility ratio (ICUR) was expressed in cost per Quality Adjusted Life Years (QALYs). Outcomes were tested by means of AN(C)OVA analyses and costs differences by means of bootstrapping. Bootstrapping, sensitivity analyses and a subgroup analysis were performed to test the robustness of the findings. RESULTS: One hundred thirteen stroke patients were included in this study. The mean differences in USER-Participation scores (95%CI:-13.08,-1.61, p-value = .013) were significant different between the two groups, this does not account for UPCC scores (95%CI:-.267, .113, p-value = not significant) and QALYs (p-value = not significant) at 12 months. The average total societal costs were not significantly different (95%CI:€-3380,€7099) for SMI (€17,333) in comparison with EDU (€15,520). Cost-effectiveness analyses showed a mean ICER of 26,514 for the UPCC and 346 for the USER-Participation. Cost-utility analysis resulted in an ICUR of €44,688 per QALY. Assuming a willingness to pay (WTP) threshold of €50,000 per QALY, the probability that SMI will be cost-effective is 52%. Sensitivity analyses and subgroup analysis showed the robustness of the results. CONCLUSIONS: SMI is probably not a cost-effective alternative in comparison with EDU. Based on the current results, the value of implementing SMI for a stroke population is debatable. We recommend further exploration of the potential cost-effectiveness of stroke-specific self-management interventions focusing on different underlying mechanisms and using different control treatments.

Economic evaluation of an experience sampling method intervention in depression compared with treatment as usual using data from a randomized controlled trial.

BACKGROUND: Experience sampling, a method for real-time self-monitoring of affective experiences, holds opportunities for person-tailored treatment. By focussing on dynamic patterns of positive affect, experience sampling method interventions (ESM-I) accommodate strategies to enhance personalized treatment of depression-at potentially low-costs. This study aimed to investigate the cost-effectiveness of an experience sampling method intervention in patients with depression, from a societal perspective. METHODS: Participants were recruited between January 2010 and February 2012 from out-patient mental health care facilities in or near the Dutch cities of Eindhoven and Maastricht, and through local advertisements. Out-patients diagnosed with major depression (n = 101) receiving pharmacotherapy were randomized into: (i) ESM-I consisting of six weeks of ESM combined with weekly feedback regarding the individual's positive affective experiences, (ii) six weeks of ESM without feedback, or (iii) treatment as usual only. Alongside this randomised controlled trial, an economic evaluation was conducted consisting of a cost-effectiveness and a cost-utility analysis, using Hamilton Depression Rating Scale (HDRS) and quality adjusted life years (QALYs) as outcome, with willingness-to-pay threshold for a QALY set at €50,000 (based on Dutch guidelines for moderate severe to severe illnesses). RESULTS: The economic evaluation showed that ESM-I is an optimal strategy only when willingness to pay is around €3000 per unit HDRS and around €40,500 per QALY. ESM-I was the least favourable treatment when willingness to pay was lower than €30,000 per QALY. However, at the €50,000 willingness-to-pay threshold, ESM-I was, with a 46% probability, the most favourable treatment (base-case analysis). Sensitivity analyses confirmed the robustness of these results. CONCLUSIONS: We may tentatively conclude that ESM-I is a cost-effective add-on intervention to pharmacotherapy in outpatients with major depression. TRIAL REGISTRATION: Netherlands Trial register, NTR1974 .

A systematic review of economic evaluations of treatments for patients with epilepsy.

The increasing number of treatment options and the high costs associated with epilepsy have fostered the development of economic evaluations in epilepsy. It is important to examine the availability and quality of these economic evaluations and to identify potential research gaps. As well as looking at both pharmacologic (antiepileptic drugs [AEDs]) and nonpharmacologic (e.g., epilepsy surgery, ketogenic diet, vagus nerve stimulation) therapies, this review examines the methodologic quality of the full economic evaluations included. Literature search was performed in MEDLINE, EMBASE, NHS Economic Evaluation Database (NHS EED), Econlit, Web of Science, and CEA Registry. In addition, Cochrane Reviews, Cochrane DARE and Cochrane Health Technology Assessment Databases were used. To identify relevant studies, predefined clinical search strategies were combined with a search filter designed to identify health economic studies. Specific search strategies were devised for the following topics: (1) AEDs, (2) patients with cognitive deficits, (3) elderly patients, (4) epilepsy surgery, (5) ketogenic diet, (6) vagus nerve stimulation, and (7) treatment of (non)convulsive status epilepticus. A total of 40 publications were included in this review, 29 (73%) of which were articles about pharmacologic interventions. Mean quality score of all articles on the Consensus Health Economic Criteria (CHEC)-extended was 81.8%, the lowest quality score being 21.05%, whereas five studies had a score of 100%. Looking at the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), the average quality score was 77.0%, the lowest being 22.7%, and four studies rated as 100%. There was a substantial difference in methodology in all included articles, which hampered the attempt to combine information meaningfully. Overall, the methodologic quality was acceptable; however, some studies performed significantly worse than others. The heterogeneity between the studies stresses the need to define a reference case (e.g., how should an economic evaluation within epilepsy be performed) and to derive consensus on what constitutes "standard optimal care."

How to prepare a systematic review of economic evaluations for informing evidence-based healthcare decisions: a five-step approach (part 1/3).

INTRODUCTION: Systematic reviews of economic evaluations are useful for synthesizing economic evidence about health interventions and for informing evidence-based decisions. Areas covered: As there is no detailed description of the methods for performing a systematic review of economic evidence, this paper aims to provide an overview of state-of-the-art methodology. This is laid out in a 5-step approach, as follows: step 1) initiating a systematic review; step 2) identifying (full) economic evaluations; step 3) data extraction, risk of bias and transferability assessment; step 4) reporting results; step 5) discussion and interpretation of findings. Expert commentary: The paper aims to help inexperienced reviewers and clinical practice guideline developers, but also to be a resource for experts in the field who want to check on current methodological developments.

Does sinus rhythm conversion after cardiac surgery affect postoperative health- related quality of life?

BACKGROUND: We investigated the impact and the predictive value of sinus rhythm at 12 months (SR12) on subscales of three different HrQoL questionnaires: SF-36., EuroQoL and MFI 20. METHODS: Data of 125 cardiac surgery patients with pre-operative AF from our previous randomized trial were used. Based on their rhythm outcome patients were divided in two groups: SR12 or AF at 12 months follow up (non-SR12). All questionnaires were self-administered pre-operatively and at 3 months, 6 months and 12 months after surgery. RESULTS: Synus rhytm at 12 months was predictive of improvement of SF36- mental score (MS, p = 0.021), Euro-QoL-MS (p = 0.009), VAS (p = 0.006), and MFI 20-MS (p = 0.009). We failed to find any significant interactions between SR12 and any of the other significant risk factors: age <65 years, paroxysmal type of AF and preoperative AF duration <12 months. In contrast, SR12 was not significant in predicting physical score (PS) subscales of any of the questionnaires (all, p > 0.05) which were predicted by age <65 years (SF36-PS, p = 0.029) by paroxysmal type of AF and age <65 years (Euro-QoL-PS, p = 0.017 and p = 0.04, respectively) and by AF duration <12 months, paroxysmal type of AF and age < 65 years (MFI 20-PS, p = 0.019, p = 0.020 and p = 0.015, respectively). CONCLUSIONS: Specific mental-related HrQoL scales are much more sensitive to sinus rhythm conversion. Sinus rithm mantainance shows significant effects on mental scores independently of other cofactors. Successful conversion to sinus rhythm after surgical ablation during cardiac surgery does not significantly affect phisical health related quality of life during 1 year follow up.

ECONOMIC EVALUATION STUDIES OF SELF-MANAGEMENT INTERVENTIONS IN CHRONIC DISEASES: A SYSTEMATIC REVIEW.

BACKGROUND: To our knowledge, there has been no overall systematic review focusing on the methodological quality of full economic evaluation studies of self-management interventions. Our objective was to systematically review the literature of full economic evaluation studies of self-management interventions in adult chronic patients and to investigate their methodological quality and cost-effectiveness. METHODS: A data extraction form was developed to assess general and randomized controlled trial (RCT) -related characteristics, quality, of the RCTs, economic information and quality of the economic evaluation studies by means of a quality assessment (CHEC-list for trial-based studies, adjusted CHEC-list for model-based studies). RESULTS: Twenty-three reports were found. Sixteen studies (73 percent) lack information on the control intervention(s). Only one study fulfilled all three criteria for quality of RCTs and five studies (23 percent) did not meet any of these criteria. This review included one model-based study; the other studies were trial-based economic evaluation studies based on a RCT. Eight studies (35 percent) used a societal perspective and 12 (60 percent) synthesized costs and effects. Seven studies were categorized into the highest category (<15 score), nine studies into the "moderate" group (9-14 score), six studies received a "low" score (<8) on the CHEC-list. Eighteen studies found the self-management intervention(s) to be cost-effective compared with other interventions Conclusions: Self-management interventions for adult chronic patients were heterogeneous and there was no clear, well-considered definition of self-management. Overall, the methodological quality of the full economic evaluation studies was moderate and, therefore, cost-effectiveness results must be interpreted with caution. Future research will benefit from further improvements in methodological quality of both economic study design and analysis, as well as a taxonomy for describing self-management interventions and their contents.

Health-related quality of life after fast-track treatment results from a randomized controlled clinical equivalence trial.

PURPOSE: This randomized clinical equivalence trial was designed to evaluate health-related quality of life (HRQoL) after fast-track treatment for low-risk coronary artery bypass (CABG) patients. METHODS: Four hundred and ten CABG patients were randomly assigned to undergo either short-stay intensive care treatment (SSIC, 8 h of intensive care stay) or control treatment (care as usual, overnight intensive care stay). HRQoL was measured at baseline and 1 month, and one year after surgery using the multidimensional index of life quality (MILQ), the EQ-5D, the Beck Depression Inventory and the State-Trait Anxiety Inventory. RESULTS: At one month after surgery, no statistically significant difference in overall HRQoL was found (MILQ-score P-value=.508, overall MILQ-index P-value=.543, EQ-5D VAS P-value=.593). The scores on the MILQ-domains, physical, and social functioning were significantly higher at one month postoperatively in the SSIC group compared to the control group (P-value=.049; 95%CI: 0.01-2.50 and P-value=.014, 95% CI: 0.24-2.06, respectively). However, these differences were no longer observed at long-term follow-up. CONCLUSIONS: According to our definition of clinical equivalence, the HRQoL of SSIC patients is similar to patients receiving care as usual. Since safety and the financial benefits of this intervention were demonstrated in a previously reported analysis, SSIC can be considered as an adequate fast-track intensive care treatment option for low-risk CABG patients.

How to deal with cost differences at baseline.

BACKGROUND: To our knowledge, adjustment for baseline imbalances in costs has never been performed in trial-based cost-effectiveness analyses. METHODS: We used data from a clinical trial performed in the Netherlands comparing two outpatient psychotherapies: schema-focused therapy (SFT) versus transference-focused psychotherapy (TFP). Costs were assessed with a cost interview. Outcome was the proportion of recovered patients measured with the Borderline Personality Disorder Severity Index (BPDSI-IV). We used three methods to adjust the costs for baseline differences: (i) mean difference adjustment, calculating total costs after baseline by adjusting the difference between groups with the difference of the mean baseline costs; (ii) delta adjustment, calculating the individual differences between patient baseline and the subsequent measurements (concerning incremental costs, this is the same as mean difference adjustment); and (iii) regression-based adjustment, adjusting total costs with a regression model, with total costs as the dependent variable and baseline costs as the independent variable. RESULTS: Mean baseline costs were 3339 euros for SFT and 4238 euros for TFP, a mean difference of 899 euros. Total unadjusted follow-up costs were 30822 euros for SFT and 36812 euros for TFP. The fraction of recovered patients was 45% for SFT and 24% for TFP. Cost-effectiveness acceptability curves show that mean difference and delta adjustments are different from the regression-based methods. CONCLUSIONS: Although the routine starting point of an analysis should always be an unadjusted analysis of the cost effectiveness, a baseline difference between treatment groups should be adjusted for. This should be done by reported patient characteristics or, when these are not sufficiently present, by baseline costs as a substitute. This adjustment should be carried out most preferably with a regression-based method.

Erythropoietin as an adjuvant treatment with (chemo) radiation therapy for head and neck cancer.

BACKGROUND: Tumour hypoxia increases tumour invasiveness and has a negative impact on response to therapy. Hypoxic tumours are also associated with severely anaemic individuals. It has therefore been hypothesised that correcting anaemia, by increasing haemoglobin levels using erythropoietin, improves tumour oxygenation and consequently the patient's prognosis. OBJECTIVES: To assess whether combined treatment with radiotherapy and erythropoietin (RT plus EPO) is better than standard radiotherapy (RT alone) for the treatment of head and neck cancer patients. SEARCH STRATEGY: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; mRCT and additional sources for published and unpublished trials. The date of the most recent search was 24 February 2009. SELECTION CRITERIA: Two independent authors assessed identified studies according to the eligibility criteria: RCTs which delivered radiotherapy combined with or without erythropoietin, in patients of any age with head and neck cancer of any stage or type. In addition, trials administering concomitant iron therapy among one or both arms were also eligible. DATA COLLECTION AND ANALYSIS: For statistical analysis of survival data, we computed a weighted estimate of the typical treatment effect across studies. We used Chi(2) heterogeneity tests to test for statistical heterogeneity among trials and performed the statistical analyses using Review Manager 5.0. MAIN RESULTS: Five RCTs with a total of 1397 patients were included. Pooled data yielded a significantly worse overall survival (OS) for RT plus EPO as compared to RT alone (Peto odds ratio 0.73; 95% confidence interval (CI) 0.58 to 0.91; P = 0.005, five trials). For local regional tumour control (LRTC) analyses resulted in a small but non-significant difference between the RT alone group and the RT plus EPO group (RR 0.92; 95% CI 0.81 to 1.03; P = 0.15, four trials). In addition, the local regional progression free survival (LRPFS) measured in four studies was significantly different between groups (Peto odds ratio 0.63; 95% CI 0.49 to 0.80; P = 0.0002, four trials), in favour of the RT alone group. Two studies used supplemental iron in the RT plus EPO group and not in the RT alone group. When excluding these studies from the analyses, the statistically (non-) significant differences in OS, LRTC and LRPFS are maintained. AUTHORS' CONCLUSIONS: There are strong suggestions that RT plus EPO has a negative influence on outcome as opposed to RT alone. However, the target haemoglobin concentration, which was higher than recommended in four of the five included RCTs, may have had a significant role. Nevertheless, based on these findings EPO should not be administered as an addition to RT outside the experimental setting for patients with head and neck cancer.

Concomitant hyperthermia and radiation therapy for treating locally advanced rectal cancer.

BACKGROUND: Surgery has been the treatment of choice for patients with rectal cancer. For locally advanced cancer results were poor, with high rates of locoregional recurrences and poor overall survival data. Adding (chemo)radiotherapy upfront improved results mainly in locoregional control. Adding hyperthermia to radiotherapy preoperatively might have an equivalent beneficial effect. OBJECTIVES: To quantify the potential beneficial effect of thermo radiation compared to chemo-radiation with respect to pathological complete responses, overall survival and toxicity in rectal cancer therapy. SEARCH STRATEGY: We identified the relevant phase II and III randomised controlled trials in any language trough electronic searches May 2007 of the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2007), the Cochrane Colorectal Cancer Groups Specialised Register, MEDLINE (from 1966), EMBASE (from 1974), CINAHL (from 1982). Furthermore, various trial databases were searched for the identification of recent completed and ongoing trials (metaRegister of Controlled Trials, Cancer Research UK, Cancer.gov, The Eastern Cooperative Oncology Group Trials Database). All studies identified until May 2007 were considered for inclusion in the present study. SELECTION CRITERIA: Only phase II and III randomised controlled clinical trials were included in the analysis. DATA COLLECTION AND ANALYSIS: All identified studies were assessed by two independent reviewers. A weighted estimate of the treatment effect was computed for 2, 3, 4 and 5-year survival, for local tumour recurrence, severe acute and late toxicity and complete tumour response (CR). CR was defined either clinically by disappearance of all pretreatment signs of local tumour or pathologically by microscopically free margins. The risk ratio (RR) and hazard ratio (HR) were used. Analyses were performed with the Reference Manager (RevMan). MAIN RESULTS: Six RCTs published between 1990 and 2007 were identified. A total number of 520 patients was treated, 258 in the radiotherapy only arm (RT) and 262 in the radiotherapy-hyperthermia arm (RHT). Four studies (424 patients) reported overall survival (OS) rates. After 2 years, OS was significantly better in the RHT group (HR 2.06; 95% CI 1.33-3.17; p=.001), but this difference disappeared after a longer period (3, 4 and 5 year OS). All but one studies reported CR rates. A significant higher CR rate was observed in the RHT group (RR 2.81; 95% CI 1.22-6.45; p=.01). Only 2 studies reported on acute toxicity. In these 2 studies no significant differences were observed between the RT and the RHT group. Late toxicity data were not reported. AUTHORS' CONCLUSIONS: Further studies are needed to compare chemoradiation versus thermoradiation versus chemoradiation plus hyperthermia in well selected/conducted and quality controlled randomised trials.

Does fast-track treatment lead to a decrease of intensive care unit and hospital length of stay in coronary artery bypass patients? A meta-regression of randomized clinical trials.

OBJECTIVE: Evaluation of randomized, controlled clinical trials studying fast-track treatment in low-risk coronary artery bypass grafting patients. DESIGN: Meta-regression. PATIENTS: Low-risk coronary artery bypass grafting patients. INTERVENTIONS: Fast-track treatments including (high or low) anesthetic dose, normothermia vs. hypothermia, and extubation protocol (within or after 8 hrs). MEASUREMENTS: Number of hours of intensive care unit stay, number of days of hospital stay, prevalence of myocardial infarction, and death. Furthermore, quality of life and cost evaluations were evaluated. The epidemiologic and economic qualities of the different trials were also assessed. MAIN RESULTS: A total of 27 studies evaluating fast-track treatment were identified, of which 12 studies were with major and 15 were without major differences in extubation protocol or anesthetic treatment or both. The use of an early extubation protocol (p=.000) but not the use of a low anesthetic dose (p=.394) or normothermic temperature management (p=.552) resulted in a decrease of the total intensive care unit stay of low-risk coronary artery bypass grafting patients. Early extubation was found to be an important determinant of the total hospital stay for these patients. An influence of the type of fast-track treatment on mortality or the prevalence of postoperative myocardial infarction was not observed. In general, the epidemiologic and economic qualities of included studies were moderate. CONCLUSIONS: Although fast-track anesthetics and normothermic temperature management facilitate early extubation, the introduction of an early extubation protocol seems essential to decrease intensive care unit and hospital stay in low-risk coronary artery bypass grafting patients.

One-year cost-effectiveness of surgical treatment of morbid obesity: vertical banded gastroplasty versus Lap-Band.

BACKGROUND: This study was designed as an economic evaluation alongside a randomized clinical trial. The object of this study was to evaluate the 1-year cost-effectiveness of surgical treatment of morbid obesity comparing two operations. METHODS: 100 patients were assigned randomly to vertical banded gastroplasty (VBG) or Lap-Band surgery. Both medical and non-medical costs were identified and measured. Costs data were combined with percentage Excess Weight Loss (%EWL) and with Quality Adjusted Life Years (QALYs) to obtain cost per %EWL and cost per QALY ratios. RESULTS: At 1 year, the total costs were not significantly different between both groups (95% confidence interval E5,999-E1,765). Also, the QALY gain after surgery was not significantly different between the two groups. However, %EWL was significantly higher in the VBG group compared to the Lap-Band group, P-value .0001. The estimated incremental cost per %EWL was E105.83 (E1,885.91/-17.82). For the costs per QALY, the estimated ratio was dominant. The overall mortality in this study was 2%. 2 patients in the VBG group died within 30 days after surgery; 1 of these deaths was possibly related to the VBG procedure. CONCLUSION: At 1 year after surgery, the costs and QoL of the two treatment modalities were found to be equal. Therefore, the selection of the procedure can be based on the clinical aspects, effectivity and safety at 1 year. In addition, the results of a long-term cost-effectiveness analysis (e.g. with a follow-up of 36 months) planned in the future can also be helpful in the selection of the preferred treatment.

Short-stay intensive care after coronary artery bypass surgery: randomized clinical trial on safety and cost-effectiveness.

OBJECTIVE: To evaluate the safety and cost-effectiveness of short-stay intensive care (SSIC) treatment for low-risk coronary artery bypass patients. DESIGN: Randomized clinical equivalence trial. SETTING: University Hospital Maastricht, the Netherlands. PATIENTS: Low-risk coronary artery bypass patients. INTERVENTIONS: A total of 600 patients were randomly assigned to undergo either SSIC treatment (8 hrs of intensive care treatment) or control treatment (care as usual, overnight intensive care treatment). MEASUREMENTS: The primary outcome measures were intensive care readmissions and total hospital stay. The secondary outcome measures were total hospital costs, quality of life, postoperative morbidity, and mortality. Hospital costs consisted of the cost of hospital admission or admissions and outpatient costs. MAIN RESULTS: The difference in intensive care readmission between the two groups of 1.13% was very small and not significantly different (p = .241; 95% confidence interval, -0.9% to 2.9%). The total hospital stay (p = .807; 95% confidence interval, 1.2 to -0.4) and postoperative morbidity were comparable between the groups. The SSIC group's quality of life improved more compared with the control group's quality of life (p = .0238; 95% confidence interval, 0.0012 to 0.0464). The total hospital costs for SSIC were significantly lower (95% confidence interval, -1,581 to -174) compared with those for the control group (4,625 and 5,441, respectively). The estimated incremental cost-effectiveness ratio (cost/delta quality-adjusted life months) thus showed the dominance of SSIC. Bootstrap and sensitivity analyses confirm the robustness of the study findings. CONCLUSIONS: Compared with usual care, SSIC is a safe and cost-effective approach. SSIC can be considered as an alternative for conventional postoperative intensive care treatment for low-risk coronary artery bypass graft patients.