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BACKGROUND & AIMS: Celiac disease (CD) is a common yet underdiagnosed autoimmune disease with substantial long-term consequences. High-accuracy point-of-care tests for CD antibodies conducted at youth primary health care centers may enable earlier identification of CD, but evidence about the cost-effectiveness of such strategies is lacking. We estimated the long-term cost-effectiveness of active case finding and mass screening compared with clinical detection in the Netherlands. METHODS: A decision tree and Markov model were used to simulate a cohort of 3-year-old children with CD according to each strategy, taking into account their impact on long-term costs (from a societal perspective) and quality-adjusted life-years (QALYs). Model parameters incorporated data from the GLUTENSCREEN project, the Dutch Celiac Society, the Dutch Pediatric Surveillance Unit, and published sources. The primary outcome was the incremental cost-effectiveness ratio (ICER) between strategies. RESULTS: Mass-screening produced 7.46 more QALYs and was 28,635 more costly compared with current care (ICER: 3841 per QALY), and case finding produced 4.33 more QALYs and was 15,585 more costly compared with current care (ICER: 3603 per QALY). At a willingness to pay of 20,000 per QALY, both strategies were highly cost-effective compared with current care. Scenario analyses indicated that mass screening is likely the optimal strategy, unless no benefit in detecting asymptomatic cases is assumed. CONCLUSIONS: An earlier identification of CD through screening or case finding in children using a point-of-care tests leads to improved health outcomes and is cost-effective in the long-term compared with current care. If the feasibility and acceptability of the proposed strategies are successful, implementation in Dutch regular care is needed.
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BACKGROUND: Healthcare organizations measure costs for business operations but do not routinely incorporate costs in decision-making on the value of care. AIM: Provide guidance on how to use costs in value-based healthcare (VBHC) delivery at different levels of the healthcare system. SETTING AND PARTICIPANTS: Integrated practice units (IPUs) for diabetes mellitus (DM) and for acute myocardial infarction (AMI) at the Leiden University Medical Center and a collaboration of seven breast cancer IPUs of the Santeon group, all in the Netherlands. PROGRAM DESCRIPTION AND EVALUATION: VBHC aims to optimize care delivery to the patient by understanding how costs relate to outcomes. At the level of shared decision-making between patient and clinician, yearly check-up consultations for DM type I were analyzed for patient-relevant costs. In benchmarking among providers, quantities of cost drivers for breast cancer care were assessed in scorecards. In continuous learning, cost-effectiveness analysis was compared with radar chart analysis to assess the value of telemonitoring in outpatient follow-up. DISCUSSION: Costs vary among providers in healthcare, but also between provider and patient. The joint analysis of outcomes and costs using appropriate methods helps identify and optimize the aspects of care that drive desired outcomes and value.
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Neoplasias da Mama , Cuidados de Saúde Baseados em Valores , Humanos , Feminino , Atenção à Saúde , Benchmarking , Países BaixosRESUMO
INTRODUCTION: Since the number of medical treatment options for Ulcerative Colitis (UC) has expanded over the last decades, patients and physicians face challenges regarding decisions about the medication options. We aimed to identify patients' preferences about their UC treatment options in the Netherlands. Furthermore, we assessed after how many failed treatment options, patients are willing to consider surgical treatment. METHODS: We conducted a web-based, multicenter, discrete choice experiment (DCE) among adult UC patients. Patients were repeatedly asked to choose between two hypothetical medicinal treatment options. The choice tasks were based on administration route, administration location, chance of symptom reduction (on short and long term) and chances on infection and other adverse events. Data were analyzed by using Hierarchical Bayes estimation. RESULTS: A total of 172 UC patients participated in the DCE. More than half were anti-TNF experienced (52.9%). The chance of symptom reduction after one year (relative importance (RI) 27.7 (95% CI 26.0-29.4)) was most important in choosing between medicinal treatments, followed by the chance of infection (RI 22.3 (21.4 - 23.3)) and chance of symptom reduction after eight weeks (RI 19.5 (18.3 - 20.6)). Considering surgical treatment, nineteen patients (14.3%) would not even consider surgery after failing eight treatment options without any new available therapies left. Nine patients would consider surgery before trying any treatment options. CONCLUSION: We found that symptom reduction after one year was the most important attribute in choosing between treatments in UC patients. These outcomes can help understand the trade-offs and preferences of UC patients.
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Colite Ulcerativa , Médicos , Adulto , Humanos , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/cirurgia , Preferência do Paciente , Teorema de Bayes , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Comportamento de EscolhaRESUMO
OBJECTIVE: Economic evaluations of treatments help to inform decisions on allocating health care resources. These evaluations involve comparing costs and effectiveness in terms of quality of life. To calculate quality-adjusted life years, generic health related quality of life is often used, but is criticized for not being sensitive to change in mental health populations. Another approach, using experienced well-being measured through capabilities with the ICECAP-A, has been proposed as an alternative. The aim of this study was to investigate whether changes in individuals with eating disorder (ED) symptoms can be better captured using health related quality of life (EQ-5D-5L) or well-being (ICECAP-A). METHOD: Measurements at two time points with an interval of 1 year were used from a sample of 233 participants with self-reported ED symptoms. An analysis of variance was used to test whether the EQ-5D-5L and ICECAP-A differed in sensitivity to change over time. In order to compare the two questionnaires in terms of clinically significant outcome, the reliable change index and clinical cut-off score were calculated. RESULTS: The two questionnaires did not differ in sensitivity to change. More individuals had recovered but also more had deteriorated according to the EQ-5D-5L compared to the ICECAP. DISCUSSION: The present study revealed no differences in sensitivity to change in health-related quality of life or well-being in individuals with ED symptoms in the context of mild clinical change. Results corroborated the pervasiveness of low quality of life in this population, even after alleviation of ED symptoms. PUBLIC SIGNIFICANCE STATEMENT: Measuring treatment benefits in terms of improvements in quality of life is an integral part of economic evaluations in health care. It was expected that these treatment benefits would be better captured as changes in well-being (measured with the ICECAP-A) than as changes in health-related quality of life (measured with the EQ-5D-5L) for individuals with ED symptoms. Based on the results of this study, no preference for one of the two approaches was found.
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Saúde Mental , Qualidade de Vida , Adulto , Humanos , Inquéritos e Questionários , Autorrelato , Análise Custo-Benefício , Psicometria/métodos , Nível de SaúdeRESUMO
PURPOSE: Financial resources for health care are limited, so assessment of intervention effectiveness in terms of health in relation to its costs is important. Measuring health outcomes in cost-effectiveness analyses is usually done by health-related quality of life measures, like the EQ-5D. However, over the past decade, innovations on the conceptual level of health have evolved and novel approaches are rising such as the capability approach, subjective wellbeing, and Positive Health. This study assesses the psychometric properties of the subjective wellbeing-5 dimension (SWB-5D) outcome measure. METHODS: A quantitative, cross-sectional study design was used to determine the concurrent and construct (convergent and known group) validity for the SWB-5D. Concurrent and convergent validity were estimated as correlations between the SWB-5D and the Dutch version of the EQ-5D, ICECAP-A, and PH-17. Assessment of known-groups validity was based on the variables illness, education, and the overall happiness (Cantril Ladder) and overall health scale (EQ-5D VAS). RESULTS: A representative sample of 1016 respondents of the Dutch population completed an online questionnaire. The SWB-5D showed reasonable concurrent validity and showed good convergent and known-group validity. The SWB-5D had a lower ceiling effect compared to the EQ-5D and ICECAP-A. CONCLUSION: Compared to traditional health measurement approaches, novel approaches are more focused on the mental and social pillars of health. The SWB-5D shows psychometric feasibility of comprehensive measurement of health, as indicated by a range of validity measures in a large representative sample of the Dutch population.
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Etnicidade , Qualidade de Vida , Humanos , Qualidade de Vida/psicologia , Psicometria/métodos , Estudos Transversais , Inquéritos e Questionários , Reprodutibilidade dos TestesRESUMO
BACKGROUND: The economic costs of mental disorders for society are huge. Internet-based interventions are often coined as cost-effective alternatives to usual care, but the evidence is mixed. OBJECTIVE: The aim was to review the literature on the cost-effectiveness of internet interventions for mental disorders compared with usual care and to provide an estimate of the monetary benefits of such interventions compared with usual care. METHODS: A systematic review and meta-analysis of randomized controlled trials was conducted, which included participants with symptoms of mental disorders; investigated a telephone- or internet-based intervention; included a control condition in the form of treatment as usual, psychological placebo, waiting list control, or bibliotherapy; reported outcomes on both quality of life and costs; and included articles published in English. Electronic databases such as PubMed (including MEDLINE), Embase, Emcare, PsycINFO, Web of Science, and the Cochrane Library were used. Data on risk of bias, quality of the economic evaluation, quality-adjusted life years, and costs were extracted from the included studies, and the incremental net benefit was calculated and pooled. RESULTS: The search yielded 6226 abstracts, and 37 studies with 14,946 participants were included. The quality of economic evaluations of the included studies was rated as moderate, and the risk of bias was high. A random-effects approach was maintained. Analyses suggested internet interventions were slightly more effective than usual care in terms of quality-adjusted life years gain (Hedges g=0.052, 95% CI 0.010-0.094; P=.02) and equally expensive (Hedges g=0.002, 95% CI -0.080 to 0.84; P=.96). The pooled incremental net benefit was US $255 (95% CI US $91 to US $419; P=.002), favoring internet interventions over usual care. The perspective of the economic evaluation and targeted mental disorder moderated the results. CONCLUSIONS: The findings indicate that the cost-effectiveness of internet interventions for mental disorders compared with a care-as-usual approach is likely, but generalizability to new studies is poor given the substantial heterogeneity. This is the first study in the field of mental health to pool cost-effectiveness outcomes in an aggregate data meta-analysis. TRIAL REGISTRATION: PROSPERO CRD42019141659; https://tinyurl.com/3cu99b34.
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Intervenção Baseada em Internet , Transtornos Mentais , Humanos , Análise Custo-Benefício , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Transtornos Mentais/terapiaRESUMO
BACKGROUND: An important element of value-based health care (VBHC) is interprofessional collaboration in integrated practice units (IPUs) for the delivery of the complete cycle of care. High levels of interprofessional collaboration between clinical and nonclinical staff in IPUs are assumed rather than proven. Factors that may stimulate interprofessional collaboration in the context of VBHC are underresearched. PURPOSE: The aim of this study was to examine relational coordination (RC) in VBHC and its antecedents. APPROACH: A questionnaire was used to examine the association of both team practices and organizational conditions with interprofessional collaboration in IPUs. Gittell's Relational Coordination Survey was drawn upon to measure interprofessional collaboration by capturing the relational dynamics in coordinated working. The questionnaire also included measures of team practices (team meetings and boundary spanning behavior) and organizational conditions (task interdependence and time constraints). RESULTS: The number of different professional groups participating in team meetings is positively associated with RC in IPUs. Boundary spanning behavior, task interdependence, and time constraints are not associated with RC. CONCLUSIONS: In IPUs, the diversity within interprofessional team meetings is important for establishing high-quality communication and relationships. PRACTICE IMPLICATIONS: Hospital managers should prioritize facilitating and encouraging shared meetings to enhance RC levels among professional groups in IPUs.
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Comportamento Cooperativo , Cuidados de Saúde Baseados em Valores , Humanos , Atenção à Saúde , Pessoal de Saúde , Instalações de Saúde , Equipe de Assistência ao Paciente , Relações InterprofissionaisRESUMO
OBJECTIVES: The ICEpop Capability Measure for Adults (ICECAP-A) assesses 5 capabilities (stability, attachment, autonomy, achievement, and enjoyment) that are important to one's quality of life and might be an important addition to generic health questionnaires currently used in economic evaluations. This study aimed to develop a Dutch tariff of the Dutch translation of the ICECAP-A. METHODS: The methods used are similar to those used in the development of the UK tariff. A profile case best-worst scaling task was presented to 1002 participants from the general Dutch population. A scale-adjusted latent class analysis was performed to test for preferences of ICECAP-A capabilities and scale heterogeneity. RESULTS: A 3-preference class 2-scale class model with worst choice as scale predictor was considered optimal and was used to calculate the resulting tariff. Results indicated that the capabilities stability, attachment, and enjoyment were considered more important aspects of quality of life than autonomy and achievement. Additionally, improving capabilities from low to moderate levels had a larger effect on quality of life than improving capabilities that were already at a higher level. CONCLUSIONS: The ICECAP-A tariffs found in this study could be used in economic evaluations of healthcare interventions in The Netherlands.
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Análise Custo-Benefício/métodos , Nível de Saúde , Inquéritos e Questionários/normas , Humanos , Países Baixos , Qualidade de VidaRESUMO
OBJECTIVE: To study the preferences of women with deep endometriosis (DE) with bowel involvement when they have to choose between conservative (medication) or surgical treatment. DESIGN: Labelled discrete choice experiment (DCE). SETTING: Dutch academic and non-academic hospitals and online recruitment. POPULATION OR SAMPLE: A total of 169 women diagnosed with DE of the bowel. METHODS: Baseline characteristics and the fear of surgery were collected. Women were asked to rank attributes and choose between hypothetical conservative or surgical treatment in different choice sets (scenarios). Each choice set offered different levels of all treatment attributes. Data were analysed by using multinomial logistic regression. MAIN OUTCOME MEASURES: The following attributes - effect on/risk of pain, fatigue, pregnancy, endometriosis lesions, mood swings, osteoporosis, temporary stoma and permanent intestinal symptoms - were used in this DCE. RESULTS: In the ranking, osteoporosis was ranked with low importance, whereas in the DCE, a lower chance of osteoporosis was one of the most important drivers when choosing a conservative treatment. Women with previous surgery showed less fear of surgery compared with women without surgery. Low anterior resection syndrome was almost equally important for patients as the chance of pain reduction. Pain reduction had higher importance than improving fertility chances, even in women with desire for a future child. CONCLUSIONS: The risk of developing low anterior resection syndrome as a result of treatment is almost equally important as the reduction of pain symptoms. Women with previous surgery experience less fear of surgery compared with women without a surgical history. TWEETABLE ABSTRACT: First discrete choice experiment in patients with deep endometriosis.
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Endometriose , Osteoporose , Doenças Retais , Neoplasias Retais , Endometriose/patologia , Endometriose/cirurgia , Feminino , Humanos , Dor , Complicações Pós-Operatórias , Gravidez , Doenças Retais/cirurgia , SíndromeRESUMO
OBJECTIVE: The primary aim was assessing the cost-effectiveness of an internet-based self-help program, expert-patient support, and the combination of both compared to a care-as-usual condition. METHOD: An economic evaluation from a societal perspective was conducted alongside a randomized controlled trial. Participants aged 16 or older with at least mild eating disorder symptoms were randomly assigned to four conditions: (1) Featback, an online unguided self-help program, (2) chat or e-mail support from a recovered expert patient, (3) Featback with expert-patient support, and (4) care-as-usual. After a baseline assessment and intervention period of 8 weeks, five online assessments were conducted over 12 months of follow-up. The main result constituted cost-utility acceptability curves with quality-of-life adjusted life years (QALYs) and societal costs over the entire study duration. RESULTS: No significant differences between the conditions were found regarding QALYs, health care costs and societal costs. Nonsignificant differences in QALYs were in favor of the Featback conditions and the lowest societal costs per participant were observed in the Featback only condition (16,741) while the highest costs were seen in the care-as-usual condition (28,479). The Featback only condition had the highest probability of being efficient compared to the alternatives for all acceptable willingness-to-pay values. DISCUSSION: Featback, an internet-based unguided self-help intervention, was likely to be efficient compared to Featback with guidance from an expert patient, guidance alone and a care-as-usual condition. Results suggest that scalable interventions such as Featback may reduce health care costs and help individuals with eating disorders that are currently not reached by other forms of treatment. PUBLIC SIGNIFICANCE STATEMENT: Internet-based interventions for eating disorders might reach individuals in society who currently do not receive appropriate treatment at low costs. Featback, an online automated self-help program for eating disorders, was found to improve quality of life slightly while reducing costs for society, compared to a do-nothing approach. Consequently, implementing internet-based interventions such as Featback likely benefits both individuals suffering from an eating disorder and society as a whole.
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Transtornos da Alimentação e da Ingestão de Alimentos , Intervenção Baseada em Internet , Análise Custo-Benefício , Transtornos da Alimentação e da Ingestão de Alimentos/terapia , Humanos , Internet , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de VidaRESUMO
PURPOSE: The ICEpop CAPability measure for Adults (ICECAP-A) assesses five capabilities that are important to one's well-being. The instrument might be an important addition to generic health questionnaires when evaluating quality of life extending beyond health. This study aimed to conduct a psychometric assessment of the Dutch translation of the ICECAP-A. METHODS: Construct validity of the instrument was assessed in two ways. First, by measuring correlations with the EQ-5D-5L questionnaire and a measure of self-efficacy and, second, by investigating the ability to distinguish between groups known to differ on the construct the ICECAP-A means to capture. Additionally, test-retest reliability was evaluated. RESULTS: In total, 1002 participants representative of the general Dutch population completed an online survey. For test-retest reliability, 252 participants completed the same questionnaire 2 weeks later. The ICECAP-A indicated moderate to strong correlations with the EQ-5D-5L and a strong correlation with self-efficacy. Furthermore, it was capable of differentiating known groups. Moreover, results indicated adequate test-retest reliability with an intraclass correlation coefficient of 0.79. CONCLUSION: In summary, results suggest adequate test-retest reliability and construct validity and indicate that the ICECAP-A might be of added value, especially when considering areas outside of the traditional health intervention model.
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Etnicidade , Qualidade de Vida , Adulto , Humanos , Psicometria/métodos , Qualidade de Vida/psicologia , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
BACKGROUND: The aim of this study was to identify and summarize how value-based healthcare (VBHC) is conceptualized in the literature and implemented in hospitals. Furthermore, an overview was created of the effects of both the implementation of VBHC and the implementation strategies used. METHODS: A scoping review was conducted by searching online databases for articles published between January 2006 and February 2021. Empirical as well as non-empirical articles were included. RESULTS: 1729 publications were screened and 62 were used for data extraction. The majority of the articles did not specify a conceptualization of VBHC, but only conceptualized the goals of VBHC or the concept of value. Most hospitals implemented only one or two components of VBHC, mainly the measurement of outcomes and costs or Integrated Practice Units (IPUs). Few studies examined effects. Implementation strategies were described rarely, and were evaluated even less. CONCLUSIONS: VBHC has a high level of interpretative variability and a common conceptualization of VBHC is therefore urgently needed. VBHC was proposed as a shift in healthcare management entailing six reinforcing steps, but hospitals have not implemented VBHC as an integrative strategy. VBHC implementation and effectiveness could benefit from the interdisciplinary collaboration between healthcare and management science. TRIAL REGISTRATION: This scoping review was registered on Open Science Framework https://osf.io/jt4u7/ (OSF | The implementation of Value-Based Healthcare: a Scoping Review).
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Atenção à Saúde , Instalações de Saúde , Custos e Análise de Custo , HumanosRESUMO
BACKGROUND: Smartphone compatible wearables have been released on the consumers market, enabling remote monitoring. Remote monitoring is often named as a tool to reduce the cost of care. OBJECTIVE: The primary purpose of this paper is to describe a cost-utility analysis of an eHealth intervention compared to regular follow-up in patients with acute myocardial infarction (AMI). METHODS: In this trial, of which clinical results have been published previously, patients with an AMI were randomized in a 1:1 fashion between an eHealth intervention and regular follow-up. The remote monitoring intervention consisted of a blood pressure monitor, weight scale, electrocardiogram device, and step counter. Furthermore, two in-office outpatient clinic visits were replaced by e-visits. The control group received regular care. The differences in mean costs and quality of life per patient between both groups during one-year follow-up were calculated. RESULTS: Mean costs per patient were 2417±2043 (US $2657±2246) for the intervention and 2888±2961 (US $3175±3255) for the control group. This yielded a cost reduction of 471 (US $518) per patient. This difference was not statistically significant (95% CI -275 to 1217; P=.22, US $-302 to $1338). The average quality-adjusted life years in the first year of follow-up was 0.74 for the intervention group and 0.69 for the control (difference -0.05, 95% CI -0.09 to -0.01; P=.01). CONCLUSIONS: eHealth in the outpatient clinic setting for patients who suffered from AMI is likely to be cost-effective compared to regular follow-up. Further research should be done to corroborate these findings in other patient populations and different care settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT02976376; https://clinicaltrials.gov/ct2/show/NCT02976376. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.8038.
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Infarto do Miocárdio , Telemedicina , Instituições de Assistência Ambulatorial , Análise Custo-Benefício , Seguimentos , Humanos , Infarto do Miocárdio/terapia , Qualidade de VidaRESUMO
BACKGROUND: Little is known about costs and effects of vision screening strategies to detect amblyopia. Aim of this study was to compare costs and effects of conventional (optotype) vision screening, photoscreening or a combination in children aged 3-6 years. METHODS: Population-based, cross-sectional study in preventive child health care in The Hague. Children aged 3 years (3y), 3 years and 9 months (3y9m) or 5-6 years (5/6y) received the conventional chart vision screening and a test with a photoscreener (Plusoptix S12C). Costs were based on test duration and additional costs for devices and diagnostic work-up. RESULTS: Two thousand, one hundred and forty-four children were included. The estimated costs per child screened were 17.44, 20.37 and 6.90 for conventional vision screening at 3y, 3y9m and 5/6y, respectively. For photoscreening, these estimates were 6.61, 7.52 and 9.40 and for photoscreening followed by vision screening if the result was unclear (combination) 9.32 (3y) and 9.33 (3y9m). The number of children detected with amblyopia by age were 9, 14 and 5 (conventional screening), 6, 13 and 3 (photoscreening) and 10 (3y) and 15 (3y9m) (combination), respectively. The estimated costs per child diagnosed with amblyopia were 1500, 1050 and 860 for conventional vision screening, 860, 420 and 1940 for photoscreening and 730 (3y) and 450 (3y9m) for the combination. CONCLUSIONS: Combining photoscreening with vision screening seems promising to detect amblyopia in children aged 3y/3y9m, whereas conventional screening seems preferable at 5/6y. As the number of study children with amblyopia is small, further research on the effects of these screening alternatives in detecting children with amblyopia is recommended.
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Ambliopia , Seleção Visual , Ambliopia/diagnóstico , Criança , Saúde da Criança , Estudos Transversais , Atenção à Saúde , Humanos , Lactente , Reprodutibilidade dos Testes , Sensibilidade e EspecificidadeRESUMO
The clinical effectiveness and scar quality of the randomized controlled trial comparing enzyme alginogel with silver sulfadiazine (SSD) for treatment of partial thickness burns were previously reported. Enzyme alginogel did not lead to faster wound healing (primary outcome) or less scar formation. In the current study, the health-related quality of life (HRQoL), costs, and cost-effectiveness of enzyme alginogel compared with SSD in the treatment of partial thickness burns were studied. HRQoL was evaluated using the Burn Specific Health Scale-Brief (BSHS-B) and the EQ-5D-5L questionnaire 1 week before discharge and at 3, 6, and 12 months postburn. Costs were studied from a societal perspective (health care and nonhealth-care costs) for a follow-up period of 1 year. A cost-effectiveness analysis was performed using cost-effectiveness acceptability curves and comparing differences in societal costs and Quality Adjusted Life Years (QALYs) at 1 year postburn. Forty-one patients were analyzed in the enzyme alginogel group and 48 patients in the SSD group. None of the domains of BSHS-B showed a statistically significant difference between the treatment groups. Also, no statistically significant difference in QALYs was found between enzyme alginogel and SSD (difference -0.03; 95% confidence interval [CI], -0.09 to 0.03; P = .30). From both the health care and the societal perspective, the difference in costs between enzyme alginogel and SSD was not statistically significant: the difference in health-care costs was 3210 (95% CI, -1247 to 7667; P = .47) and in societal costs was 3377 (95% CI -6229 to 12 982; P = .49). The nonsignificant differences in costs and quality-adjusted life-years in favor of SSD resulted in a low probability (<25%) that enzyme alginogel is cost-effective compared to SSD. In conclusion, there were no significant differences in quality of life between both treatment groups. Enzyme alginogel is unlikely to be cost-effective compared with SSD in the treatment of partial thickness burns.
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Alginatos/uso terapêutico , Anti-Infecciosos Locais/uso terapêutico , Queimaduras/economia , Queimaduras/terapia , Glucose Oxidase/uso terapêutico , Lactoperoxidase/uso terapêutico , Polietilenoglicóis/uso terapêutico , Qualidade de Vida , Sulfadiazina de Prata/uso terapêutico , Adulto , Idoso , Alginatos/economia , Anti-Infecciosos Locais/economia , Queimaduras/patologia , Análise Custo-Benefício , Combinação de Medicamentos , Feminino , Glucose Oxidase/economia , Humanos , Lactoperoxidase/economia , Masculino , Pessoa de Meia-Idade , Polietilenoglicóis/economia , Sulfadiazina de Prata/economia , Fatores de Tempo , Resultado do Tratamento , CicatrizaçãoRESUMO
An amendment to this paper has been published and can be accessed via the original article.
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BACKGROUND: Caloric restriction is an effective way to treat Type 2 diabetes (T2D). However, chronic and severe restriction of food intake is difficult to sustain and is known to promote slower metabolism. Intermittent and frequent fasting can exert similar metabolic effects, but may be even more challenging for most patients. A fasting-mimicking diet (FMD) is low in calories, sugars and proteins, but includes relatively high levels of plant based complex carbohydrates and healthy fats. The metabolic effects of such a diet mimic the benefits of water-only fasting. The effects of a FMD applied periodically in T2D patients are still unknown. The Fasting In diabetes Treatment (FIT) trial was designed to determine the effect of intermittent use (5 consecutive days a month during a year) of a FMD in T2D patients on metabolic parameters and T2D medication use compared to usual care. METHODS: One hundred T2D patients from general practices in the Netherlands with a BMI ≥ 27 kg/m2, treated with lifestyle advice only or lifestyle advice plus metformin, will be randomised to receive the FMD plus usual care or usual care only. Primary outcomes are HbA1c and T2D medication dosage. Secondary outcomes are anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome composition, MRI data including cardiac function, fat distribution and ectopic fat storage, cost-effectiveness, and feasibility in clinical practice. DISCUSSION: This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D. Furthermore, additional health benefits and the feasibility in clinical practice will be measured and a cost-effectiveness evaluation will be performed. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov. Identifier: NCT03811587. Registered 21th of January, 2019; retrospectively registered.
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Biomarcadores/análise , Diabetes Mellitus Tipo 2/dietoterapia , Dieta , Jejum , Qualidade de Vida , Projetos de Pesquisa , Adolescente , Adulto , Idoso , Glicemia/análise , Intervenção Médica Precoce , Feminino , Seguimentos , Hemoglobinas Glicadas/análise , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Método Simples-Cego , Adulto JovemRESUMO
PURPOSE: Inflammatory bowel disease (IBD) patients experience diverse symptoms and the impact of these different symptoms varies substantially. Current disease activity measures do not account for the relative importance of the different symptoms and severity levels. In this study, we aimed to quantify the relative importance of different symptoms for IBD patients and to develop a patient preference-weighted symptom (PWS) score to assess symptom burden in IBD. METHODS: We performed a choice-based conjoint analysis (CBCA) survey with 129 IBD patients to estimate the relative importance of four common IBD symptoms: stool frequency, abdominal pain, blood in stools, and urgency. We then developed the PWS score using the preferences obtained from the CBCA, which we validated against existing measures. RESULTS: CBCA revealed that urgency was the most important symptom to patients, followed by abdominal pain and blood in stools. Urgency associated with incontinence received particularly high scores and was perceived to be more than 3 times as important as urgency without incontinence. Our results confirmed that different symptoms are not equally bothersome, and we showed that the relation between symptom-level and importance is not linear. The PWS score, which we developed using these estimates was highly correlated with existing disease activity measures. CONCLUSIONS: We quantified the relative importance of four common IBD symptoms and developed the PWS score for IBD, which takes the relative importance of different symptoms and symptom-levels into account. The PWS score can be used to obtain a patient-centered assessment of symptom burden.
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Doenças Inflamatórias Intestinais/diagnóstico , Qualidade de Vida/psicologia , Feminino , Humanos , Doenças Inflamatórias Intestinais/fisiopatologia , Masculino , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Mental health problems often arise in childhood and adolescence and can have detrimental effects on people's quality of life (QoL). Therefore, it is of great importance for clinicians, policymakers and researchers to adequately measure QoL in children. With this review, we aim to provide an overview of existing generic measures of QoL suitable for economic evaluations in children with mental health problems. METHODS: First, we undertook a meta-review of QoL instruments in which we identified all relevant instruments. Next, we performed a systematic review of the psychometric properties of the identified instruments. Lastly, the results were summarized in a decision tree. RESULTS: This review provides an overview of these 22 generic instruments available to measure QoL in children with psychosocial and or mental health problems and their psychometric properties. A systematic search into the psychometric quality of these instruments found 195 suitable papers, of which 30 assessed psychometric quality in child and adolescent mental health. CONCLUSIONS: We found that none of the instruments was perfect for use in economic evaluation of child and adolescent mental health care as all instruments had disadvantages, ranging from lack of psychometric research, no proxy version, not being suitable for young children, no age-specific value set for children under 18, to insufficient focus on relevant domains (e.g. social and emotional domains).
Assuntos
Transtornos Mentais , Qualidade de Vida , Adolescente , Criança , Pré-Escolar , Humanos , Transtornos Mentais/diagnóstico , Saúde Mental , Procurador , Psicometria , Inquéritos e QuestionáriosRESUMO
BACKGROUND AND AIMS: To optimize therapeutic decision-making in early invasive colorectal cancer (T1 CRC) patients, it is important to elicit the patient's perspective next to considering medical outcome. Because empirical data on patient-reported impact of different treatment options are lacking, we evaluated patients' quality of life, perceived time to recovery, and fear of cancer recurrence after endoscopic or surgical treatment for T1 CRC. METHODS: In this cross-sectional study, we selected patients with histologically confirmed T1 CRC who participated in the Dutch Bowel Cancer Screening Programme and received endoscopic or surgical treatment between January 2014 and July 2017. Quality of life was measured using the European Organization for Research and Treatment 30-item Core Quality of Life Questionnaire and the 5-level EuroQoL 5-dimension questionnaire. We used the Cancer Worry Scale (CWS) to evaluate patients' fear of cancer recurrence. A question on perceived time to recovery after treatment was also included in the set of questionnaires sent to patients. RESULTS: Of all 119 eligible patients, 92.4% responded to the questionnaire (endoscopy group, 55/62; surgery group, 55/57). Compared with the surgery group, perceived time to recovery was on average 3 months shorter in endoscopically treated patients after adjustment for confounders (19.9 days vs 111.3 days; P = .001). The 2 treatment groups were comparable with regard to global quality of life, functioning domains, and symptom severity scores. Moreover, patients in the endoscopy group did not report more fear of cancer recurrence than those in the surgery group (CWS score, 0-40; endoscopy 7.6 vs surgery 9.7; P = .140). CONCLUSIONS: From the patient's perspective, endoscopic treatment provides a quicker recovery than surgery, without provoking more fear of cancer recurrence or any deterioration in quality of life. These results contribute to the shared therapeutic decision-making process of clinicians and T1 CRC patients.