Global representativeness and impact of funding sources in cost-effectiveness research on systemic therapies for advanced breast cancer: A systematic review.

BACKGROUND: Breast cancer (BC) is the most incident tumor and, consequently, any new intervention can potentially promote a considerable budget impact if incorporated. Cost-effectiveness (CE) studies assist in the decision-making process but may be influenced by the country's perspective of analysis and pharmaceutical industry funding. METHODS: A systematic review of Medline, Scopus, and Web of Science from January 1st, 2012 to July 8th, 2022 was conducted to identify CE studies of tumor-targeted systemic-therapies for advanced BC. Articles without incremental cost-effectiveness ratio calculations were excluded. We extracted information on the country and class of drug studied, comparator type, authors' conflicts of interest (COI), pharmaceutical industry funding, and authors' conclusions. RESULTS: 71 studies comprising 204 CE assessments were included. The majority of studies were from the United States and Canada (44%), Asia (32%) and Europe (20%). Only 8% were from Latin America and none from Africa. 31% had pharmaceutical industry funding. The most studied drug classes were cyclin-dependent-kinase inhibitors (29%), anti-HER2 therapy (23%), anti-PD(L)1 (11%) and hormone therapy (11%). Overall, 34% of CE assessments had favorable conclusions. Pharmaceutical industry-funded articles had a higher proportion of at least one favorable conclusion (82% vs. 24%, p-value<0.001), European countries analyzed (45% vs. 9%, p-value = 0.003), and CE assessments with same class drug comparators (56% vs. 33%, p-value = 0.004). CONCLUSIONS: Breast cancer CE literature scarcely represents low-and-middle-income countries' perspectives and is influenced by pharmaceutical industry funding which targets European countries', frequently utilizes comparisons within same-drug class, and is more likely to have favorable conclusions.

Spiritual needs among hospitalized patients at a public hospital in Brazil: a cross-sectional study

ABSTRACT BACKGROUND: The relationship between spirituality and health has been the object of growing discussion. There is a lack of data on spiritual needs assessments in Brazil. OBJECTIVE: This study aimed to assess the spiritual needs of patients admitted to a public tertiary hospital and perform a comparative analysis between patients with and without indications for palliative care. DESIGN AND SETTING: A cross-sectional observational study included patients hospitalized between August and December 2020 in Hospital do Servidor Publico Municipal, Sao Paulo, Brazil. METHODS: The included patients answered a questionnaire consisting of sociodemographic data, the Duke religiosity scale, and the Spiritual Needs Assessment for Patients (SNAP) tool for a spiritual needs assessment. The World Health Organization Palliative Needs tool (NECPAL) was used to evaluate the indications for palliative care. The level of significance adopted was 5%. RESULTS: A total of 66 patients were included in this study. Most participants (97%) declared themselves as belonging to a religion. The group without indication for palliative care by the NECPAL showed greater spiritual (P = 0.043) and psychosocial needs (P = 0.004). No statistically significant difference was observed in the religious needs domain (P = 0.176). There were no statistically significant differences in the Duke scale scores between the two groups. CONCLUSION: Spiritual, psychosocial, and religious needs are prevalent among hospitalized patients, and multidisciplinary teams must consider these needs in their management approach. In addition, this study suggests that psychosocial and spiritual needs can be even higher in patients who do not receive palliative care.

Economic evaluation of plerixafor addition in the mobilization and leukapheresis of hematopoietic stem cells for autologous transplantation: a systematic review.

INTRODUCTION: Although plerixafor in association with granulocyte colony-stimulating factor (G-CSF) can improve mobilization and collection of hematopoietic stem cells (HSC) by leukapheresis, cost may limit its clinical application. The present study systematically reviews economic evaluations of plerixafor plus G-CSF usage compared to G-CSF alone and compares different strategies of plerixafor utilization in multiple myeloma and lymphoma patients eligible for autologous HSC transplantation. AREAS COVERED: Relevant economic evaluations, partial or complete, were searched on PubMed, Embase, LILACS, and Cochrane Central Register of Controlled Trials for a period ending 30 June 2021. This systematic review was reported following the PRISMA Statement. Six economic evaluations were included, considering the use of upfront or just-in-time plerixafor compared to G-CSF alone or other plerixafor strategies. Most comparisons showed both increased cost and health benefits with the addition of plerixafor. Most analyses favored just-in-time plerixafor compared to upfront plerixafor, with a probable preference for broader cutoffs for just-in-time plerixafor initiation. EXPERT OPINION: Plerixafor is a potentially cost-effective technology in the mobilization of HSC in patients with multiple myeloma and lymphomas eligible for autologous HSC transplantation. There is a decreased number of leukapheresis sessions and remobilizations and a higher yield of CD34+ cells.

Spiritual needs among hospitalized patients at a public hospital in Brazil: a cross-sectional study.

BACKGROUND: The relationship between spirituality and health has been the object of growing discussion. There is a lack of data on spiritual needs assessments in Brazil. OBJECTIVE: This study aimed to assess the spiritual needs of patients admitted to a public tertiary hospital and perform a comparative analysis between patients with and without indications for palliative care. DESIGN AND SETTING: A cross-sectional observational study included patients hospitalized between August and December 2020 in Hospital do Servidor Publico Municipal, Sao Paulo, Brazil. METHODS: The included patients answered a questionnaire consisting of sociodemographic data, the Duke religiosity scale, and the Spiritual Needs Assessment for Patients (SNAP) tool for a spiritual needs assessment. The World Health Organization Palliative Needs tool (NECPAL) was used to evaluate the indications for palliative care. The level of significance adopted was 5%. RESULTS: A total of 66 patients were included in this study. Most participants (97%) declared themselves as belonging to a religion. The group without indication for palliative care by the NECPAL showed greater spiritual (P = 0.043) and psychosocial needs (P = 0.004). No statistically significant difference was observed in the religious needs domain (P = 0.176). There were no statistically significant differences in the Duke scale scores between the two groups. CONCLUSION: Spiritual, psychosocial, and religious needs are prevalent among hospitalized patients, and multidisciplinary teams must consider these needs in their management approach. In addition, this study suggests that psychosocial and spiritual needs can be even higher in patients who do not receive palliative care.

Decision criteria for resource allocation: an analysis of CONITEC oncology reports. / Critérios de decisão para a alocação de recursos: uma análise de relatórios da CONITEC na área de oncologia.

In health technology assessment (HTA), decision criteria are considered relevant to support the complex deliberative process that requires simultaneous consideration of multiple factors. The aim was to identify and analyze the decision criteria that have been used by the National Health Technology Assessment Commission (CONITEC) when recommending the incorporation of technologies for the treatment of cancer. Descriptive study, based on reports from CONITEC, between 2012 and 2018, on oncology technologies. The data were collected in a specific extraction form and analyzed using descriptive statistics. 39 reports were analyzed, 15 of them did not present any explicit decision criteria. Medicines were the most frequently evaluated type of technology. The most frequent types of cancers were: breast cancer, head and neck cancer, colorectal cancer, non-Hodgkin's lymphoma and lung cancer. The most frequently considered criteria were: financial impact and effectiveness. The study identified the decision criteria that have been most used in the area of ​​oncology, however, the lack of transparency in relation to the weight of these criteria makes it difficult to understand their influence on the result of the decisions taken.

Nos processos de avaliação de tecnologias em saúde (ATS), critérios de decisão são considerados relevantes para apoiar o complexo processo deliberativo que requer consideração simultânea de múltiplos fatores. Objetivou-se identificar e analisar os critérios de decisão que têm sido utilizados pela Comissão Nacional de Avaliação de Tecnologias em Saúde (CONITEC) na recomendação de incorporação de tecnologias para o tratamento do câncer. Trata-se de um estudo descritivo, baseado em relatórios da CONITEC, entre 2012 e 2018, sobre tecnologias em oncologia. Os dados foram coletados em formulário de extração específico e analisados por meio de estatísticas descritivas. Foram analisados 39 relatórios, 15 deles não apresentavam nenhum critério de decisão explícito. Os medicamentos constituíram o tipo de tecnologia mais frequentemente avaliado. Os tipos de cânceres mais frequentes foram: de mama, de cabeça e pescoço, colorretal, linfoma não Hodgkin e de pulmão. Os critérios considerados com mais frequência foram: impacto financeiro e efetividade. O estudo identificou os critérios de decisão que têm sido mais utilizados na área de oncologia, entretanto, a falta de transparência em relação ao peso desses critérios torna difícil compreender a influência deles no resultado das decisões tomadas.

Multiple Criteria Decision Analysis (MCDA) for evaluating cancer treatments in hospital-based health technology assessment: The Paraconsistent Value Framework.

BACKGROUND: In recent years, the potential of multi-criteria decision analysis (MCDA) in the health field has been discussed widely. However, most MCDA methodologies have given little attention to the aggregation of different stakeholder individual perspectives. OBJECTIVE: To illustrate how a paraconsistent theory-based MCDA reusable framework, designed to aid hospital-based Health Technology Assessment (HTA), could be used to aggregate individual expert perspectives when valuing cancer treatments. METHODS: An MCDA methodological process was adopted based on paraconsistent theory and following ISPOR recommended steps in conducting an MCDA study. A proof-of-concept exercise focusing on identifying and assessing the global value of first-line treatments for metastatic colorectal cancer (mCRC) was conducted to foster the development of the MCDA framework. RESULTS: On consultation with hospital-based HTA committee members, 11 perspectives were considered in an expert panel: medical oncology, oncologic surgery, radiotherapy, palliative care, pharmacist, health economist, epidemiologist, public health expert, health media expert, pharmaceutical industry, and patient advocate. The highest weights were assigned to the criteria "overall survival" (mean 0.22), "burden of disease" (mean 0.21) and "adverse events" (mean 0.20), and the lowest weights were given to "progression-free survival" and "cost of treatment" (mean 0.18 for both). FOLFIRI and mFlox scored the highest global value score of 0.75, followed by mFOLFOX6 with a global value score of 0.71. mIFL was ranked last with a global value score of 0.62. The paraconsistent analysis (para-analysis) of 6 first-line treatments for mCRC indicated that FOLFIRI and mFlox were the appropriate options for reimbursement in the context of this study. CONCLUSION: The Paraconsistent Value Framework is proposed as a step beyond the current MCDA practices, in order to improve means of dealing with individual expert perspectives in hospital-based HTA of cancer treatments.

Multicriteria decision analysis in health care decision in oncology: a systematic review.

INTRODUCTION: Multicriteria decision analysis (MCDA) has been used to inform health decisions in health technology assessments (HTA) processes. This is particularly important to complex treatment decisions in oncology. AREAS COVERED: Five databases (PubMed, EMBASE, LILACS, Web of Science and CRD's NHS Economic Evaluation Database) were searched for studies comparing health technologies in oncology, involving the concept MCDA. The ISPOR MCDA Good Practices Guidelines were used to assess the reporting quality. Study selection, appraisal, and data extraction were performed by two reviewers. Fifteen studies were included. The main decision problem was related to health technology assessment of cancer treatments. Clinicians and public health experts were the most frequent stakeholders. The most frequently included criteria comprised therapeutic benefit, and socio-economic impact. Value measurement approach, direct rating techniques, and additive model for aggregation were used in most studies. Uncertainty analysis revealed the impact of posology and costs on the studies' results. All studies showed some level of overlapping decision criteria. EXPERT OPINION: There is considerable diversity of methods in MCDA for healthcare decision-making in oncology. The evidence presented can serve as a resource when considering which stakeholders, criteria, and techniques to include in future MCDA studies in oncology.

Palliative cancer care: costs in a Brazilian quaternary hospital.

Palliative care (PC) improves the quality of life of patients with diseases such as cancer, and several studies have shown a reduction in costs among patients who use PC services when compared with those receiving standard oncological treatments. Most studies on PC costs are carried out in high-income countries. There is a lack of these types of studies in middle-income and low-income countries and of better evidence about this intervention. OBJECTIVE: To describe resource utilisation and costs among patients with cancer in a Brazilian quaternary hospital by cancer localisation and per month of treatment before death. METHODS: This study is a description of retrospective costs to estimate the costs of formal healthcare sector associated with PCs, from the perspective of a public quaternary cancer hospital. Unit costs were estimated using microcosting and macrocosting approaches. SETTING/PARTICIPANTS: Patients older than 18 years old who died from 2010 to 2013 and who had at least two visits in PC and/or made use of hospice care. RESULTS: Among the 2985 patients included in the study, the average cost per patient was US$12 335, ranging from US$8269 for patients with pancreatic cancer to US$19 395 for patients with brain cancer. The main costing item was hospital admission (47.6% of the total cost), followed by hospice care (29.5%) and medical and other supplies (11.1%). CONCLUSIONS: The study clarified the direct medical costs and the profile and use of resources of patients with cancer who need PC, and can help in the planning and allocation of resources in cancer care.

Cost-effectiveness analysis of trastuzumab for early breast cancer in Brazil.

BACKGROUND: Adjuvant chemotherapy with trastuzumab for HER2 positive breast cancers has brought considerable benefits to disease-free survival and overall survival. OBJECTIVE: To conduct a cost-effectiveness analysis of the treatment of patients with early and locally advanced HER2 positive breast cancer, within the scope of the Brazilian public health system, comparing adjuvant chemotherapy with and without trastuzumab, for 1 year of treatment. METHODS: A 4-state Markov model was developed to estimate strategy costs and outcomes. RESULTS: Based on the proposed model, we verified an incremental benefit of trastuzumab therapy compared to treatment without trastuzumab with 0.84 quality-adjusted life years (QALY) and 1.16 life years gained (LYG). The use of adjuvant chemotherapy with trastuzumab has an ICER of US$19,599.26 for each quality-adjusted life year and US$14,180.68 for each life year gained in relation to chemotherapy without trastuzumab. CONCLUSION: In Brazil, adjuvant chemotherapy with trastuzumab may be considered cost-effective only if a cost-effectiveness threshold is stipulated with the value starting at three times the Brazilian GDP per capita for QALY or two times the Brazilian GDP per capita for LYG, from health system perspective.

Critérios de decisão para a alocação de recursos: uma análise de relatórios da CONITEC na área de oncologia / Decision criteria for resource allocation: an analysis of CONITEC oncology reports

Resumo Nos processos de avaliação de tecnologias em saúde (ATS), critérios de decisão são considerados relevantes para apoiar o complexo processo deliberativo que requer consideração simultânea de múltiplos fatores. Objetivou-se identificar e analisar os critérios de decisão que têm sido utilizados pela Comissão Nacional de Avaliação de Tecnologias em Saúde (CONITEC) na recomendação de incorporação de tecnologias para o tratamento do câncer. Trata-se de um estudo descritivo, baseado em relatórios da CONITEC, entre 2012 e 2018, sobre tecnologias em oncologia. Os dados foram coletados em formulário de extração específico e analisados por meio de estatísticas descritivas. Foram analisados 39 relatórios, 15 deles não apresentavam nenhum critério de decisão explícito. Os medicamentos constituíram o tipo de tecnologia mais frequentemente avaliado. Os tipos de cânceres mais frequentes foram: de mama, de cabeça e pescoço, colorretal, linfoma não Hodgkin e de pulmão. Os critérios considerados com mais frequência foram: impacto financeiro e efetividade. O estudo identificou os critérios de decisão que têm sido mais utilizados na área de oncologia, entretanto, a falta de transparência em relação ao peso desses critérios torna difícil compreender a influência deles no resultado das decisões tomadas.

Abstract In health technology assessment (HTA), decision criteria are considered relevant to support the complex deliberative process that requires simultaneous consideration of multiple factors. The aim was to identify and analyze the decision criteria that have been used by the National Health Technology Assessment Commission (CONITEC) when recommending the incorporation of technologies for the treatment of cancer. Descriptive study, based on reports from CONITEC, between 2012 and 2018, on oncology technologies. The data were collected in a specific extraction form and analyzed using descriptive statistics. 39 reports were analyzed, 15 of them did not present any explicit decision criteria. Medicines were the most frequently evaluated type of technology. The most frequent types of cancers were: breast cancer, head and neck cancer, colorectal cancer, non-Hodgkin's lymphoma and lung cancer. The most frequently considered criteria were: financial impact and effectiveness. The study identified the decision criteria that have been most used in the area of ​​oncology, however, the lack of transparency in relation to the weight of these criteria makes it difficult to understand their influence on the result of the decisions taken.

Effects of 3D image-guided brachytherapy compared to 2D conventional brachytherapy on clinical outcomes in patients with cervical cancer: A systematic review and meta-analyses.

PURPOSE: To assess the effects of three-dimensional image-guided brachytherapy (3D BT) compared to bi-dimensional BT (2D BT) on clinical outcomes in patients with cervical cancer. METHODS AND MATERIALS: We searched PubMed/MEDLINE, EMBASE, Scopus, CENTRAL, Web of Science, and LILACS for studies assessing the effects of 3D BT versus 2D BT on clinical outcomes. Two reviewers independently screened retrieved citations, extracted data and assessed risk of bias from eligible studies. Hazard ratios (HR) were calculated from Kaplan-Meier curves considering the number of events, their timing and the followup of censored patients. We conducted meta-analyses of HR using the inverse-variance random-effects method. Risk Difference (RD) for toxicities were pooled using the Mantel-Haenszel random-effects method. We used the GRADE system to rate the certainty of evidence. RESULTS: Twenty observational studies involving 4287 patients were included. The meta-analyses assessing the effect of 3D BT versus 2D BT on overall survival resulted in a HR of 0.78 (95%CI 0.62-0.98), HR of 0.75 (95%CI 0.62-0.90) for pelvic disease-free survival, HR of 0.93 (95%CI 0.81-1.06) for metastatic disease-free survival, and HR of 0.77 (95%CI 0.59-0.99) for local control. Grade 3-4 global and gastrointestinal toxicities were, respectively, 9% lower (95%CI 6% to 11%) and 5% lower (95%CI 2% to 8%) in patients receiving 3D BT versus 2D BT. Certainty of evidence was very low for all assessed outcomes. CONCLUSIONS: Our study may suggest a benefit of 3D BT over conventional 2D BT on important clinical outcomes.

Factors associated with the costs of palliative care: a retrospective cost analysis at a university Cancer hospital in Brazil

Background: There have been few studies evaluating the costs of palliative care (PC) in low- and middle-income countries (LMICs), especially for patients with cancer. Objectives: The objective of this study was to identify the sociodemographic and clinical variables that could explain the cost per day of PC for cancer in Brazil. Methods: This was a retrospective cost analysis of PC at a quaternary cancer center in São Paulo, Brazil, between January 2010 and December 2013. Factors influencing the cost per day were assessed with generalized linear models and generalized linear-mixed models in which the random effect was the site of the cancer. Results: The study included 2985 patients. The mean total cost per patient was $12,335 (standard deviation [SD] = 14,602; 95% confidence interval [CI] = 11,803 to 12,851). The mean cost per day per patient was $325.50 (SD = 246.30, 95% CI = 316.60 to 334.30). There were statistically significant differences among cancer sites in terms of the mean cost per day. Multivariate analysis revealed that the drivers of cost per day were Karnofsky performance status, the number of hospital admissions, referral to PC, and place of death. Place of death had the greatest impact on the cost per day; death in a hospital and in hospice care increased the mean cost per day by $1.56 and $1.83, respectively. Conclusion: To allocate resources effectively, PC centers in LMICs should emphasize early enrollment of patients at PC outpatient clinics, to avoid hospital readmission, as well as advance planning of the place of death.

A Comparison of UK and Brazilian SF-6D Preference Weights When Applied to a Brazilian Urban Population.

BACKGROUND: The 6-dimensional health state short form (SF-6D) is a health preference measure used in economic evaluations of many treatments. OBJECTIVES: To compare the results provided by the SF-6D index, when applied to a representative sample of the Brazilian population, using Brazilian and UK preference weights. METHODS: Five thousand individuals were assessed in the 5 regions of Brazil. Preference measures in healthcare were assessed using the SF-6D Brazil, version 2002. To calculate the single utility score, 2 preference weights were used: one established for the Brazilian population (SF-6D Brazil) and the other for the UK population (SF-6D UK). Agreement between the SF-6D Brazil and the SF-6D UK was assessed using the intraclass correlation coefficient, the Wilcoxon signed rank test, confidence intervals (CIs), and the Bland-Altman method. RESULTS: The mean values of the SF-6D Brazil and the SF-6D UK were 0.83 ± 0.15 and 0.84 ± 0.15, respectively. The intraclass correlation coefficient was 0.952 (CI 0.942-0.960; P<.010). The Wilcoxon signed rank test and CI showed a statistically significant difference between the 2 measures; this difference was, however, very small and considered clinically irrelevant (CI 0.011-0.013; P<.010). Using the Bland-Altman method resulted in a mean difference of 0.012 and the limits of agreement were between -0.077 and 0.101. CONCLUSIONS: The present study identified very small quantitative differences between UK- and Brazilian-derived SF-6D scores. Tests of agreement, however, showed that the impact of using different sets of preference weights in the construction of quality-adjusted life-year might be considered irrelevant.

Integrated care pathway for rectal cancer treatment: cross-sectional post-implementation study using a logic model framework.

BACKGROUND: Management of rectal cancer has become more complex with multimodality therapy (neoadjuvant chemoradiotherapy and surgery) and this has led to the need to organize multidisciplinary teams. The aim of this study was to report on the planning, implementation and evaluation of an integrated care pathway for neoadjuvant treatment of middle and lower rectal cancer. DESIGN AND SETTING: This was a cross-sectional post-implementation study that was carried out at a public university cancer center. METHODS: The Framework for Program Evaluation in Public Health of the Centers for Disease Control and Prevention (CDC) was used to identify resources and activities; link results from activities and outcomes with expected goals; and originate indicators and outcome measurements. RESULTS: The logic model identified four activities: stakeholders' engagement, clinical pathway development, information technology improvements and training programs; and three categories of outcomes: access to care, effectiveness and organizational outcomes. The measurements involved 218 patients, among whom 66.3% had their first consultation within 15 days after admission; 75.2% underwent surgery < 14 weeks after the end of neoadjuvant treatment and 72.7% completed the treatment in < 189 days. There was 100% adherence to the protocol for the regimen of 5-fluorouracil and leucovorin. CONCLUSIONS: The logic model was useful for evaluating the implementation of the integrated care pathways and for identifying measurements to be made in future outcome studies.

Cost effectiveness of the cancer prevention program for carriers of the BRCA1/2 mutation.

OBJECTIVE: To analyze the cost effectiveness of the diagnostic program for the germline mutation in BRCA1/2 genes and of preventative strategies for the relatives of patients diagnosed with ovarian cancer associated with this mutation. METHODS: The study analyzed the cost effectiveness by developing an analysis of the Markov decision process from the perspective of the National Health System. The strategies compared reflect upon the adoption of genetic testing and preventative strategies for relatives or the usual care currently proposed. The incremental cost-effectiveness ratio was expressed in terms of cost per case avoided. The sensitivity analysis was performed in a univariate and deterministic manner. RESULTS: The study showed increments for effectiveness and for costs when performing genetic testing and adopting prophylactic measures for family members. The incremental cost-effectiveness ratio was estimated at R$908.58 per case of cancer avoided, a figure considered lower than the study's cost-effectiveness threshold (R$7,543.50). CONCLUSIONS: The program analyzed should be considered a cost-effective strategy for the national situation. Studies in various other countries have reached similar conclusions. One possible ramification of this research might the need to perform a budgetary-impact analysis of making the program one of the country's health policies.

Value-based medicine in oncology: the importance of perspective in the emerging value frameworks.

Recently, professional and healthcare-related entities have launched frameworks designed to assess the value of cancer innovations in multistakeholder decision processes. Among the most visible entities that propose and implement value frameworks in oncology are the European Society of Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO), the Memorial Sloan Kettering Cancer Center (MSKCC) and the National Comprehensive Cancer Network (NCCN). However, these value frameworks have been criticized for conceptual inconsistencies, inability to include a greater variety of value criteria, and inadequate explanation of the uncertainty approach used in the modeling process. On the other hand, Multi-Criteria Decision Analysis (MCDA) is a set of methods and processes that allow the multiple criteria involved in a decision to be explicitly addressed. This approach allows the identification of relevant decision criteria, gathering of evidence based on scientific literature, attribution of weights to the criteria and scores to the evidence raised, and aggregation of the weighted scores to constitute a global metric of value. The purpose of this article is to review the main features of these value frameworks in oncology and the importance of perspective for framework readiness to support healthcare decision-making based on MCDA methodology.

Cost-effectiveness of on-pump and off-pump coronary artery bypass grafting for patients with coronary artery disease: Results from the MASS III trial.

BACKGROUND: Recent trials have reported similar clinical outcomes between on-pump and off-pump coronary artery bypass graft (CABG). However, long-term cost-effectiveness of these strategies is unknown. METHODS: A prespecified economic study was performed based on the MASS III trial. Costs were estimated for all patients based on observed healthcare resource usage over a 5-year follow-up. Health state utilities were evaluated with the SF-6D questionnaire. Cost-effectiveness was assessed as cost per quality-adjusted life-year (QALY) gained using a Markov model. Probabilistic sensitivity analysis with the Monte-Carlo simulation and cost-effectiveness acceptability curve were used to address uncertainty. RESULTS: Quality of life improved significantly in both groups during follow-up compared with baseline. At 5 years, when comparing on-pump and off-pump CABG groups, no differences were found in cumulative life-years (4.851 and 4.766 years, P = .319) and QALY gained (4.150 and 4.105 QALYs, P = .332). Mean cost in US dollars per patient during the trial did not differ significantly between the on-pump and off-pump groups ($5890.29 and $5674.75, respectively, P = .409). Over a lifetime horizon, the incremental cost-effectiveness ratio of on-pump versus off-pump CABG was $12,576 per QALY gained, which is above the suggested cost-effectiveness threshold range (from $3210 to 10,122). In the sensitivity analysis, the probability that on-pump CABG is cost-effective compared to off-pump surgery for a willingness-to-pay threshold of $3212 per QALY gained was <1%. For the $10,122 per QALY threshold, the same probability was 35%. CONCLUSION: This decision-analytic model suggests that on-pump CABG is not cost-effective when compared to off-pump CABG from a public health system perspective.

Simple but not simpler: a systematic review of Markov models for economic evaluation of cervical cancer screening.

The aim of this study was to critically evaluate the quality of the models used in economic evaluations of screening strategies for cervical cancer prevention. We systematically searched multiple databases, selecting model-based full economic evaluations (cost-effectiveness analyses, cost-utility analyses, and cost-benefit analyses) of cervical cancer screening strategies. Two independent reviewers screened articles for relevance and performed data extraction. Methodological assessment of the quality of the models utilized formal checklists, and a qualitative narrative synthesis was performed. Thirty-eight articles were reviewed. The majority of the studies were conducted in high-income countries (82%, n=31). The Pap test was the most used screening strategy investigated, which was present in 86% (n=33) of the studies. Half of the studies (n=19) used a previously published Markov model. The deterministic sensitivity analysis was performed in 92% (n=35) of the studies. The mean number of properly reported checklist items was 9 out of the maximum possible 18. Items that were better reported included the statement of decision problem, the description of the strategies/comparators, the statement of time horizon, and information regarding the disease states. Compliance with some items of the checklist was poor. The Markov models for economic evaluation of screening strategies for cervical cancer varied in quality. The following points require improvement: 1) assessment of methodological, structural, heterogeneity, and parameter uncertainties; 2) model type and cycle length justification; 3) methods to account for heterogeneity; and 4) report of consistency evaluation (through calibration and validation methods).

Quality of life in a sample of Brazilian adults using the generic SF-12 questionnaire.

OBJECTIVE: This study describes the summary scores of the Short Form-12 (SF-12) questionnaire, according to socio-demographic factors obtained in a probabilistic and representative sample of the Brazilian urban population. METHOD: Five thousand (5,000) individuals, over the age of 15, were assessed in 16 capital cities, in the five regions of the country. The selection of households was random. Face-to-face approach was applied in the household interviews. The SF-12 questionnaire was used to assess quality of life. Demographic and socioeconomic characteristics were also evaluated: gender, age, marital status, skin color, region of the country and use of the public health service. RESULTS: The mean value (SD) of the SF-12 for the entire population was 49.3 (8.7) for the physical component (PCS-12) and 52.7 (9.7) for the mental component (MCS-12). Statistical differences were found for gender (PCS-12 and MCS-12), age (PCS-12) and working status (PCS-12 and MCS-12). Women, elderly, widowed and unemployed individuals, those with lower income and with complaints in the last seven days showed lower mean values (PCS-12 and MCS-12). CONCLUSION: From this point forward, we can provide the basis for comparisons with future research that use the SF-12 for quality of life assessment in Brazil. The Brazilian population has a lower degree of quality of life related do the physical component, and the SF-12 is a useful and discriminative instrument for assessing quality of life in different socio-demographic groups.

Quality of life in a sample of Brazilian adults using the generic SF-12 questionnaire / Qualidade de vida em uma amostra de adultos brasileiros utilizando o questionário genérico SF-12

Summary Objective: This study describes the summary scores of the Short Form-12 (SF-12) questionnaire, according to socio-demographic factors obtained in a probabilistic and representative sample of the Brazilian urban population. Method: Five thousand (5,000) individuals, over the age of 15, were assessed in 16 capital cities, in the five regions of the country. The selection of households was random. Face-to-face approach was applied in the household interviews. The SF-12 questionnaire was used to assess quality of life. Demographic and socioeconomic characteristics were also evaluated: gender, age, marital status, skin color, region of the country and use of the public health service. Results: The mean value (SD) of the SF-12 for the entire population was 49.3 (8.7) for the physical component (PCS-12) and 52.7 (9.7) for the mental component (MCS-12). Statistical differences were found for gender (PCS-12 and MCS-12), age (PCS-12) and working status (PCS-12 and MCS-12). Women, elderly, widowed and unemployed individuals, those with lower income and with complaints in the last seven days showed lower mean values (PCS-12 and MCS-12). Conclusion: From this point forward, we can provide the basis for comparisons with future research that use the SF-12 for quality of life assessment in Brazil. The Brazilian population has a lower degree of quality of life related do the physical component, and the SF-12 is a useful and discriminative instrument for assessing quality of life in different socio-demographic groups.

Resumo Objetivo: Este estudo descreve os escores sumários do questionário Short Form-12 (SF-12), de acordo com os fatores sociodemográficos obtidos em uma amostra probabilística e representativa da população urbana brasileira. Método: Cinco mil (5.000) indivíduos, com idade superior a 15 anos, foram avaliados nas cinco regiões do país, em 16 capitais. A seleção dos domicílios foi aleatória. A coleta de dados foi realizada através de entrevistas domiciliares. O questionário SF-12 foi utilizado para a avaliação de qualidade de vida. Características demográficas e socioeconômicas também foram avaliadas: sexo, idade, estado civil, cor da pele, região do país e uso do serviço público de saúde. Resultados: O valor médio (DP) do SF-12 para a população total foi de 49,3 (8,7) para o componente físico (PCS-12) e 52,7 (9,7) para o componente mental (MCS-12). Foram encontradas diferenças estatísticas para sexo (PCS-12 e MCS-12), idade (PCS-12) e estado laboral (PCS-12 e MCS-12). Mulheres, idosos, viúvos, indivíduos que não estavam trabalhando, pessoas com menor renda e queixas nos últimos sete dias apresentaram valores médios mais baixos (PCS-12 e MCS-12). Conclusão: Os resultados apresentados fornecem bases populacionais para comparações com pesquisas futuras que utilizem o SF-12 para a avaliação da qualidade de vida no Brasil. A população brasileira tem um menor grau de qualidade de vida relacionada ao componente físico, e o SF-12 é um instrumento útil e discriminativo para a avaliação de qualidade de vida em diferentes grupos sociodemográficos.