Photobiomodulation for Oral Mucositis - A Microcosting and Budget Impact Analysis from a Brazilian Perspective

ABSTRACT Objective: To measure the costs of preventive and therapeutic protocols of Photobiomodulation (PBM) for oral mucositis (OM) and their budgetary impact on Brazil's Ministry of Health (BMH). Material and Methods: A partial economic analysis was performed to estimate the costs using a bottom-up approach from a social perspective. Monetary values were assigned in Brazilian reais (BRL). The costs of the preventive protocol were calculated for five, 30, and 33 consecutive PBM sessions, depending on the antineoplastic treatment instituted. The costs of the therapeutic protocol were calculated for 5 or 10 sessions. The annual financial and budgetary impact was calculated considering the groups of oncologic patients with a higher risk of development of OM, such as those with head and neck and hematological cancer and pediatric patients. Results: The cost of a PBM session was estimated at BRL 23.75. The financial impact of providing one preventive protocol per year for all oncologic patients would be BRL 14,282,680.00, 0.030% of the estimated budget for hospital and outpatient care of the BMH in 2022. The financial and budgetary impacts of providing one treatment for OM for all patients in one year would be BRL 2,225,630.31 (0.005%, most optimistic scenario) and BRL 4,451,355.63 (0.009%, most pessimistic scenario). Conclusion: The budgetary impact of implementing PBM protocols in the Brazilian Healthcare System is small, even in a pessimistic scenario.

The incremental cost of non-alcoholic steatohepatitis and type 2 diabetes in the United States using real-world data.

BACKGROUND: Non-alcoholic steatohepatitis (NASH) and type 2 diabetes (T2D) are both linked to substantial healthcare costs and are often co-occurring. We aim to quantify the incremental cost of NASH and T2D using real-world data. METHODS: Adults (≥18 years old) with ≥2 diagnosis codes for NASH and/or ≥2 diagnosis codes for T2D between 1/1/2016 and 12/31/2021 and ≥24 months of continuous claims enrollment (study period) were identified in electronic health records or claims in the Veradigm Integrated Dataset. Patients were stratified into 3 cohorts: NASH-only, T2D-only, and NASH + T2D. We calculated annualized costs for the 24-month study period and fit a generalized linear model (excluding the most expensive 1%) that controlled for disease cohort, age, sex, and modified Charlson comorbidity index to estimate the per year all-cause healthcare costs and incremental cost of adding T2D to a NASH diagnosis (or vice versa). RESULTS: We identified 23,111 patients diagnosed with NASH-only, 3,548,786 patients with T2D-only, and 30,339 patients with NASH + T2D. The model-predicted mean costs per year were $7,668 for patients with NASH-only, $11,226 for patients with T2D-only, and $16,812 for patients with NASH + T2D. The incremental increase in costs per year of adding T2D to NASH was 63% (+$4,846), and the incremental increase in costs per year of adding NASH to T2D was 42% (+$4,692). CONCLUSIONS: Both NASH and T2D contribute to the high healthcare costs among patients with a dual diagnosis. Results from our analysis indicate that NASH comprises a high portion of total healthcare costs among patients with NASH and T2D.

[Budget impact of self-testing in the national cervical cancer screening program]. / Impact budgétaire de l'utilisation de l'autotest dans le cadre du programme national de dépistage du cancer du col de l'utérus.

OBJECTIVES: A nationwide screening program for cervical cancer (CC) was organized in 2018 as part of the 2014-2019 French cancer plan, with the objective of reducing CC incidence and mortality in France by reaching an 80 % coverage rate. As an alternative to pap smear, vaginal self-sampling (VSS) aimed at identifying high-risk HPV carriage could help to achieve this goal. The objective of the present study is to compare the respective budgetary impacts of several self-sampling strategies. METHOD: A budget impact model was developed to compare non-use of self-sampling in CC screening to the 5-year costs of 5 VSS strategies viewed from an all-payer perspective. While the first strategy was based on mailing the VSS kit with a reminder to participate in the screening program, the second was based on accompanying the mailed kit with an invitation to participate. The third and fourth strategies were based on providing health professionals with the kit, and thereby offering self-sampling as an alternative to pap smears for women undergoing CC screening and having previously received the kits. Finally, the fifth strategy was based on self-sampling as the one and only CC screening modality. The parameters of the model were based on past screening participation data and experiments in France on organized screening and VSS use. The costs included those of procedures associated with screening and program organization. RESULTS: All in all, the costs associated with cervical cancer screening would represent approximately 1 billion euros over 5 years. All strategies would be associated with participation ranging from 81% to 84%, which would represent an increase of 4.7% to 5.2% of lesions diagnosed by screening and a cost reduction between €30M and €87M over 5 years, with the exception of the strategy based on sending the kit (with the reminder associated or not) to the health professionals offering this option (+€23M and +€6M). CONCLUSIONS: In conclusion, the use of self-sampling as an alternative to pap smears for non-participating women would increase participation, with only a moderate budgetary impact and could, in some cases, even induce savings.

Health and economic burden due to alcohol-associated liver diseases in the Union Territory of Delhi: A Markov probabilistic model approach.

BACKGROUND: Nearly one-fifth of all deaths attributable to alcohol are due to liver diseases. METHODS: The study employs a Markov Probabilistic Modeling approach considering various clinical spectrum of alcohol-associated liver diseases (ALD), to gauge the health and economic burden due to ALD for the national capital territory of Delhi, from March 2017 to February 2018. The health impact was estimated through Disability Adjusted Life Years (DALYs), years of life lost (YLL), and total deaths due to ALD. The economic burden of ALD was assessed assuming the current health-seeking preferences and assuming that all the diseased individuals are cared for in the public health systems. Sensitivity analysis was done by Monte Carlo simulations. RESULTS: Total number of estimated deaths due to ALD in the national capital territory of Delhi for one year period from March 2017 was 8367. The DALYs due to ALD were estimated to be 0.247 million life years; this includes 0.178 million YLL and 0.069 million life years lost due to disability. The total cost of treating ALD was estimated to be 92.94 billion Indian rupees, if patients sought care based on current preferences and 55.52 billion Indian rupees if all diseased individuals were cared for in public health systems. The total excise revenue due to alcohol to the Government is being Indian rupees 43.1 billion in the said year. CONCLUSION: The high burden of ALD in terms of lives lost, DALYs lost, and more than two times higher estimated expense for care than the revenue generation due to alcohol clearly indicates that it would be prudent to initiate social engineering and preventive strategies to lessen the growing burden of ALD in India. The Delhi model for health and economic burden of ALD could help the country develop policies for better health outcomes of these patients.

Protocol of a population-based prospective COVID-19 cohort study Munich, Germany (KoCo19).

BACKGROUND: Due to the SARS-CoV-2 pandemic, public health interventions have been introduced globally in order to prevent the spread of the virus and avoid the overload of health care systems, especially for the most severely affected patients. Scientific studies to date have focused primarily on describing the clinical course of patients, identifying treatment options and developing vaccines. In Germany, as in many other regions, current tests for SARS-CoV2 are not conducted on a representative basis and in a longitudinal design. Furthermore, knowledge about the immune status of the population is lacking. Nonetheless, these data are needed to understand the dynamics of the pandemic and hence to appropriately design and evaluate interventions. For this purpose, we recently started a prospective population-based cohort in Munich, Germany, with the aim to develop a better understanding of the state and dynamics of the pandemic. METHODS: In 100 out of 755 randomly selected constituencies, 3000 Munich households are identified via random route and offered enrollment into the study. All household members are asked to complete a baseline questionnaire and subjects ≥14 years of age are asked to provide a venous blood sample of ≤3 ml for the determination of SARS-CoV-2 IgG/IgA status. The residual plasma and the blood pellet are preserved for later genetic and molecular biological investigations. For twelve months, each household member is asked to keep a diary of daily symptoms, whereabouts and contacts via WebApp. If symptoms suggestive for COVID-19 are reported, family members, including children < 14 years, are offered a pharyngeal swab taken at the Division of Infectious Diseases and Tropical Medicine, LMU University Hospital Munich, for molecular testing for SARS-CoV-2. In case of severe symptoms, participants will be transferred to a Munich hospital. For one year, the study teams re-visits the households for blood sampling every six weeks. DISCUSSION: With the planned study we will establish a reliable epidemiological tool to improve the understanding of the spread of SARS-CoV-2 and to better assess the effectiveness of public health measures as well as their socio-economic effects. This will support policy makers in managing the epidemic based on scientific evidence.

Lenvatinib and sorafenib for differentiated thyroid cancer after radioactive iodine: a systematic review and economic evaluation.

BACKGROUND: Thyroid cancer is a rare cancer, accounting for only 1% of all malignancies in England and Wales. Differentiated thyroid cancer (DTC) accounts for ≈94% of all thyroid cancers. Patients with DTC often require treatment with radioactive iodine. Treatment for DTC that is refractory to radioactive iodine [radioactive iodine-refractory DTC (RR-DTC)] is often limited to best supportive care (BSC). OBJECTIVES: We aimed to assess the clinical effectiveness and cost-effectiveness of lenvatinib (Lenvima®; Eisai Ltd, Hertfordshire, UK) and sorafenib (Nexar®; Bayer HealthCare, Leverkusen, Germany) for the treatment of patients with RR-DTC. DATA SOURCES: EMBASE, MEDLINE, PubMed, The Cochrane Library and EconLit were searched (date range 1999 to 10 January 2017; searched on 10 January 2017). The bibliographies of retrieved citations were also examined. REVIEW METHODS: We searched for randomised controlled trials (RCTs), systematic reviews, prospective observational studies and economic evaluations of lenvatinib or sorafenib. In the absence of relevant economic evaluations, we constructed a de novo economic model to compare the cost-effectiveness of lenvatinib and sorafenib with that of BSC. RESULTS: Two RCTs were identified: SELECT (Study of [E7080] LEnvatinib in 131I-refractory differentiated Cancer of the Thyroid) and DECISION (StuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine-refractory thyrOid caNcer). Lenvatinib and sorafenib were both reported to improve median progression-free survival (PFS) compared with placebo: 18.3 months (lenvatinib) vs. 3.6 months (placebo) and 10.8 months (sorafenib) vs. 5.8 months (placebo). Patient crossover was high (≥ 75%) in both trials, confounding estimates of overall survival (OS). Using OS data adjusted for crossover, trial authors reported a statistically significant improvement in OS for patients treated with lenvatinib compared with those given placebo (SELECT) but not for patients treated with sorafenib compared with those given placebo (DECISION). Both lenvatinib and sorafenib increased the incidence of adverse events (AEs), and dose reductions were required (for > 60% of patients). The results from nine prospective observational studies and 13 systematic reviews of lenvatinib or sorafenib were broadly comparable to those from the RCTs. Health-related quality-of-life (HRQoL) data were collected only in DECISION. We considered the feasibility of comparing lenvatinib with sorafenib via an indirect comparison but concluded that this would not be appropriate because of differences in trial and participant characteristics, risk profiles of the participants in the placebo arms and because the proportional hazard assumption was violated for five of the six survival outcomes available from the trials. In the base-case economic analysis, using list prices only, the cost-effectiveness comparison of lenvatinib versus BSC yields an incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) gained of £65,872, and the comparison of sorafenib versus BSC yields an ICER of £85,644 per QALY gained. The deterministic sensitivity analyses show that none of the variations lowered the base-case ICERs to < £50,000 per QALY gained. LIMITATIONS: We consider that it is not possible to compare the clinical effectiveness or cost-effectiveness of lenvatinib and sorafenib. CONCLUSIONS: Compared with placebo/BSC, treatment with lenvatinib or sorafenib results in an improvement in PFS, objective tumour response rate and possibly OS, but dose modifications were required to treat AEs. Both treatments exhibit estimated ICERs of > £50,000 per QALY gained. Further research should include examination of the effects of lenvatinib, sorafenib and BSC (including HRQoL) for both symptomatic and asymptomatic patients, and the positioning of treatments in the treatment pathway. STUDY REGISTRATION: This study is registered as PROSPERO CRD42017055516. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

WHAT WAS THE PROBLEM?: Differentiated thyroid cancer is a common type of thyroid cancer. For many patients, radioactive iodine is an effective treatment; however, for some patients, the treatment stops working or becomes unsafe. Two new drugs, lenvatinib (Lenvima®; Eisai Ltd, Hertfordshire, UK) and sorafenib (Nexar®; Bayer HealthCare, Leverkusen, Germany), may be new treatment options. WHAT DID WE DO?: We reviewed the clinical evidence of lenvatinib and sorafenib. We also estimated the costs and benefits of treatment. WHAT DID WE FIND?: Compared with no treatment, treatment with lenvatinib or sorafenib may increase the time that people live with thyroid cancer before their disease gets worse; however, both drugs are expensive and may have unpleasant side effects. WHAT DOES THIS MEAN?: At their published (undiscounted) prices, lenvatinib or sorafenib may not be considered to provide good value for money to the NHS.

Teaching work routine: challenges to nursing professors in contemporary times / Cotidiano laboral docente: enfrentamientos de los profesores de enfermería en la contemporaneidade / Cotidiano laboral docente: enfrentamentos dos professores de enfermagem na contemporaneidade

Abstract Objective: To describe the organization of nursing professors' work and analyze its limiting and facilitating aspects. Method: A qualitative and descriptive study composed of professors from the federal public universities of Rio de Janeiro. Data collection took place through semi-structured interviews. The content analysis technique was used for data processing. Results: Twenty-seven (27) professors participated. Facilitating elements of the teaching work were: work environment; autonomy and flexibility; liking what they do; use of technologies; and solidarity of the professional group; while hindering elements included: high work demand; intense work rhythm; scarcity of material and human resources; and academic competitiveness. Conclusion: The configuration of the teaching work organization is complex and multifaceted, presenting high psycho-affective, cognitive and physical demands which enhance illness in these workers.

Resumen Objetivo: Describir la organización del trabajo del docente de enfermería y analizar sus aspectos limitadores y facilitadores. Método: Investigación cualitativa y descriptiva, compuesta de docentes de universidades públicas federales de Río de Janeiro. La recolección de datos ocurrió mediante entrevista semiestructurada. La técnica para el tratamiento de los datos fue el análisis de contenido. Resultados: Participaron 27 docentes. Los elementos facilitadores del trabajo docente fueron: ambiente laboral; autonomía y flexibilidad; aprecio por lo que hace; empleo de las tecnologías; y solidaridad del colectivo profesional. Los elementos dificultadores fueron: alta demanda de trabajo; ritmo laboral intenso; escasez de recurso material y humano; y competitividad académica. Conclusión: La configuración de la organización laboral docente es compleja y multifacética, presentando alta exigencia psicoafectiva, cognitiva y física, lo que potencia que se enfermen dichos trabajadores.

Resumo Objetivo: Descrever a organização do trabalho do docente de enfermagem e analisar seus aspectos limitadores e facilitadores. Método: Pesquisa qualitativa e descritiva, composta por docentes de universidades públicas federais do Rio de Janeiro. A coleta de dados ocorreu em por meio de entrevista semiestruturada. A técnica para o tratamento dos dados foi a análise de conteúdo. Resultados: Participaram 27 docentes. Os elementos facilitadores do trabalho docente foram: ambiente de trabalho; autonomia e flexibilidade; gosto pelo que faz; uso das tecnologias; e solidariedade do coletivo profissional. Os elementos dificultadores foram: alta demanda de trabalho; ritmo laboral intenso; escassez de recursos material e humano; e competitividade acadêmica. Conclusão: A configuração da organização laboral docente é complexa e multifacetada, apresentando alta exigência psicoafetiva, cognitiva e física, o que potencializa o adoecimento desses trabalhadores.

Rethinking Data Sharing at the Dawn of a Health Data Economy: A Viewpoint.

A health data economy has begun to form, but its rise has been tempered by the profound lack of sharing of both data and data products such as models, intermediate results, and annotated training corpora, and this severely limits the potential for triggering economic cluster effects. Economic cluster effects represent a means to elicit benefit from economies of scale from internal data innovations and are beneficial because they may mitigate challenges from external sources. Within institutions, data product sharing is needed to spark data entrepreneurship and data innovation, and cross-institutional sharing is also critical, especially for rare conditions.

Integrating economics into the rationale for multisectoral action on obesity.

Obesity is a compelling example of the challenges of championing and mobilizing a response that involves the whole of government and all of society. This paper discusses the need for economic rationales to strengthen the case for government intervention on obesity, with a view to better engaging the expertise and resources of nonhealth sectors. The paper also briefly reviews economic theory and evidence that could support an integrated multisectoral rationale for action, noting opportunities to expand the integration of economic evidence in the Americas.

La obesidad es un ejemplo contundente de los retos que implica el defender y movilizar una respuesta que abarque a todo el gobierno y toda la sociedad. En este artículo se aborda la necesidad de contar con fundamentos económicos para respaldar la pertinencia de la intervención gubernamental en materia de obesidad, a fin de incorporar la pericia y los recursos de sectores ajenos al sector de la salud. En el artículo también se examina brevemente la teoría económica y la evidencia que podrían sustentar un fundamento multisectorial integrado para la acción, a la vez que se destacan las oportunidades para ampliar la integración de la evidencia económica en la Región de las Américas.

A obesidade é um bom exemplo do desafio de defender e mobilizar uma resposta que envolva o governo e a sociedade como um todo. Este artigo aborda a necessidade de fundamentação econômica para fortalecer o argumento para a intervenção do governo na obesidade visando atrair mais conhecimento especializado e recursos dos setores externos à saúde. O artigo analisa resumidamente a teoria econômica e as evidências que poderiam embasar uma fundamentação multissetorial integrada para ação e destaca as oportunidades para ampliar a integração das evidências econômicas nas Américas.

Integrating economics into the rationale for multisectoral action on obesity / Integrar la economía en los fundamentos de la acción multisectorial en materia de obesidad / Integrar aspectos econômicos à fundamentação para ação multissetorial em obesidade

ABSTRACT Obesity is a compelling example of the challenges of championing and mobilizing a response that involves the whole of government and all of society. This paper discusses the need for economic rationales to strengthen the case for government intervention on obesity, with a view to better engaging the expertise and resources of nonhealth sectors. The paper also briefly reviews economic theory and evidence that could support an integrated multisectoral rationale for action, noting opportunities to expand the integration of economic evidence in the Americas.

RESUMEN La obesidad es un ejemplo contundente de los retos que implica el defender y movilizar una respuesta que abarque a todo el gobierno y toda la sociedad. En este artículo se aborda la necesidad de contar con fundamentos económicos para respaldar la pertinencia de la intervención gubernamental en materia de obesidad, a fin de incorporar la pericia y los recursos de sectores ajenos al sector de la salud. En el artículo también se examina brevemente la teoría económica y la evidencia que podrían sustentar un fundamento multisectorial integrado para la acción, a la vez que se destacan las oportunidades para ampliar la integración de la evidencia económica en la Región de las Américas.

RESUMO A obesidade é um bom exemplo do desafio de defender e mobilizar uma resposta que envolva o governo e a sociedade como um todo. Este artigo aborda a necessidade de fundamentação econômica para fortalecer o argumento para a intervenção do governo na obesidade visando atrair mais conhecimento especializado e recursos dos setores externos à saúde. O artigo analisa resumidamente a teoria econômica e as evidências que poderiam embasar uma fundamentação multissetorial integrada para ação e destaca as oportunidades para ampliar a integração das evidências econômicas nas Américas.

[Costs of allergic diseases and saving potential by allergen-specific immunotherapy : A personal assessment]. / Kosten allergischer Erkrankungen und Einsparpotenziale durch die allergenspezifische Immuntherapie : Eine persönliche Bewertung.

BACKGROUND: The burden of allergic diseases is of particular relevance for the economy and the social welfare and health insurance framework. Allergic rhinitis (AR) has a life-time prevalence of approximately 30% and is one of the most common chronic diseases with considerable socioeconomic impact thus leading to substantial direct, indirect and intangible costs. This article explores the common hypothesis that allergen-specific immunotherapy (ASIT) saves national economic expenses in the long term in comparison to other standard symptomatic treatment or no therapy. METHODS: We conducted a selective search and analysis of the literature in PubMed and Medline including otherwise listed publications in German. Using a predefined model and data extrapolation over 9 years for data from different sources and short-term clinical studies we further discuss the problems and difficulties in analyzing heterogeneous datasets. RESULTS: Using a health-economic model with currently available and accepted variables ASIT proves to be cost-effective in comparison to symptomatic treatment in allergic rhinitis; however, numerous parameters from other models have to be controlled, such as adherence to therapy and therapy discontinuation, heterogeneous costs for different treatment modalities, effect sizes with respect to symptoms including cross-influences with symptomatic rescue medication, duration of efficacy after treatment discontinuation and asthma protection. DISCUSSION: The personal appraisal of the authors demonstrates not only the current knowledge but also the problems in health economical evaluation of ASIT in allergic diseases.

An Economic Model of Professional Doula Support in Labor in British Columbia, Canada.

INTRODUCTION: Spending on care in childbirth represents a sizable portion of health care budgets. This has engendered a growing interest in potential clinical tools that could be used to improve patient experience and population health at a lower cost. A possible such tool is continuous support in labor from a trained doula, as doula care can decrease the likelihood of cesarean birth, epidural analgesia, and assisted vaginal birth. In addition, there is some emerging evidence suggesting that involving doulas in prenatal care can reduce rates of preterm birth. METHODS: We used data on the associations between doula care and these outcomes derived from a Cochrane review of continuous labor support to create an economic model of universal doula support in the Canadian province of British Columbia. These relative risks were used to estimate procedure reductions and the resulting cost savings using data on the number of relevant procedures performed from Perinatal Services BC coupled with cost information from the Canadian Institutes for Health Information. RESULTS: For the calendar year 2013, we estimated savings in Canadian dollars (CaD) of CaD $10,428,171 (95% confidence interval [CI], $5,430,650-$14,434,740) if every low-risk birth were attended by a professional doula, not including the cost of the doula's services. Including reduction in preterm birth increases total savings to CaD $17,847,370 (95% CI, $6,772,341-$27,054,610). A professional doula providing labor support would yield an estimated savings of CaD $269.55 (95% CI, $141.70-$374.14) per low-risk birth or CaD $418.67 (95% CI, $158.87-$634.65) if including reductions in preterm birth. Any cost savings disappear at a doula reimbursement rate above CaD $418.67 per birth. DISCUSSION: There is potential to reduce health care costs while improving patient experience and population health by providing universal doula coverage. However, our results suggest that reimbursement rates for doulas would have to be lower than the current range (CaD $300-$1500).

Impact of Medicare Part D on out-of-pocket drug costs and medical use for patients with cancer.

BACKGROUND: Medicare Part D was designed to reduce out-of-pocket (OOP) costs for Medicare beneficiaries, but to the authors' knowledge the extent to which this occurred for patients with cancer has not been measured to date. The objective of the current study was to examine the impact of Medicare Part D eligibility on OOP cost for prescription drugs and use of medical services among patients with cancer. METHODS: Using the Medical Expenditure Panel Survey (MEPS) for the years 2002 through 2010, a differences-in-differences analysis estimated the effects of Medicare Part D eligibility on OOP pharmaceutical costs and medical use. The authors compared per capita OOP cost and use between Medicare beneficiaries (aged ≥65 years) with cancer to near-elderly patients aged 55 years to 64 years with cancer. Statistical weights were used to generate nationally representative estimates. RESULTS: A total of 1878 near-elderly and 4729 individuals with Medicare were included (total of 6607 individuals). The mean OOP pharmaceutical cost for Medicare beneficiaries before the enactment of Part D was $1158 (standard error, ±$52) and decreased to $501 (standard error, ±$30), a decline of 43%. Compared with changes in OOP pharmaceutical costs for nonelderly patients with cancer over the same period, the implementation of Medicare Part D was associated with a further reduction of $356 per person. Medicare Part D appeared to have no significant impact on the use of medications, hospitalizations, or emergency department visits, but was associated with a reduction of 1.55 in outpatient visits. CONCLUSIONS: Medicare D has reduced OOP prescription drug costs and outpatient visits for seniors with cancer beyond trends observed for younger patients, with no major impact on the use of other medical services noted.

Determinantes de la participación en actividades físicas en el Perú / Determinants of participation in physical activity in Peru

En el presente documento se trata de establecer los determinantes de la participación en actividades físicas en el Perú a partir de la estructura económica presentada en Cawley y un modelo de elección de participación propuesto por Humprheys y Ruseski. A través de la Encuesta Nacional de Indicadores Nutricionales, Bioquímicos, Socioeconómicos y Culturales Relacionados con las Enfermedades Crónico - Degenerativas (ENIN) de 2006, se estimó un modelo logístico mediante el cual se observó que individuos más educados tienen una mayor probabilidad de participar en actividades físicas. Se describe, además, que las características como el estatus socioeconómico y trabajar disminuyen la probabilidad de participar en actividades físicas debido a un mayor costo de oportunidad. Del mismo modo, se observa que las personas adultas presentan una menor probabilidad de participar en actividades físicas debido a características biológicas.

This document attempts to establish the determinants of participation in physical activity in Peru using the economic structure presented by Cawley and a participation choice model proposed by Humphreys and Ruseski. Through the National Survey of Nutritional, Biochemical, Socioeconomic and Cultural Indicators related to Chronic-Degenerative Diseases in 2006, a logistic model was estimated through which an observation was made: more educated individuals are more likely to participate in physical activities. Also, characteristics like socioeconomic status and employment decrease the likelihood of participating in physical activities due to a higher opportunity cost. In the same way, it was observed that adults are less likely to participate in physical activities due to biological characteristics related to age.

Bone graft substitutes for the treatment of traumatic fractures of the extremities.

UNLABELLED: HEALTH POLITICAL AND SCIENTIFIC BACKGROUND: Bone graft substitutes are increasingly being used as supplements to standard care or as alternative to bone grafts in the treatment of traumatic fractures. RESEARCH QUESTIONS: The efficacy and cost-effectiveness of bone graft substitutes for the treatment of traumatic fractures as well as the ethical, social and legal implications of their use are the main research questions addressed. METHODS: A systematic literature search was conducted in electronic medical databases (MEDLINE, EMBASE etc.) in December 2009. Randomised controlled trials (RCT), where applicable also containing relevant health economic evaluations and publications addressing the ethical, social and legal aspects of using bone graft substitutes for fracture treatment were included in the analysis. After assessment of study quality the information synthesis of the medical data was performed using metaanalysis, the synthesis of the health economic data was performed descriptively. RESULTS: 14 RCT were included in the medical analysis, and two in the heath economic evaluation. No relevant publications on the ethical, social and legal implications of the bone graft substitute use were found. In the RCT on fracture treatment with bone morphogenetic protein-2 (BMP-2) versus standard care without bone grafting (RCT with an elevated high risk of bias) there was a significant difference in favour of BMP-2 for several outcome measures. The RCT of calcium phosphate (CaP) cement and bone marrow-based composite materials versus autogenous bone grafts (RCT with a high risk of bias) revealed significant differences in favour of bone graft substitutes for some outcome measures. Regarding the other bone graft substitutes, almost all comparisons demonstrated no significant difference. The use of BMP-2 in addition to standard care without bone grafting led in the study to increased treatment costs considering all patients with traumatic open fractures. However, cost savings through the additional use of BMP-2 were calculated in a patient subgroup with high-grade open fractures (Gustilo-Anderson grade IIIB). Cost-effectiveness for BMP-2 versus standard care with autologous bone grafts as well as for other bone graft substitutes in fracture treatment has not been determined yet. DISCUSSION: Although there were some significant differences in favour of BMP-2, due to the overall poor quality of the studies the evidence can only be interpreted as suggestive for efficacy. In the case of CaP cements and bone marrow-based bone substitute materials, the evidence is only weakly suggestive for efficacy. From an overall economic perspective, the transferability of the results of the health economic evaluations to the current situation in Germany is limited. CONCLUSIONS: The current evidence is insufficient to evaluate entirely the use of different bone graft substitutes for fracture treatment. From a medical point of view, BMP-2 is a viable alternative for treatment of open fractures of the tibia, especially in cases where bone grafting is not possible. Autologous bone grafting is preferable comparing to the use of OP-1. Possible advantages of CaP cements and composites containing bone marrow over autogenous bone grafting should be taken into account in clinical decision making. The use of the hydroxyapatite material and allograft bone chips compared to autologous bone grafts cannot be recommended. From a health economic perspective, the use of BMP-2 in addition to standard care without bone grafting is recommended as cost-saving in patients with high-grade open fractures (Gustilo-Anderson grade IIIB). Based on the current evidence no further recommendations can be made regarding the use of bone graft substitutes for the treatment of fractures. To avoid legal implications, use of bone graft substitutes outside their approved indications should be avoided.

The effectiveness of interventions in workplace health promotion as to maintain the working capacity of health care personal.

BACKGROUND: The increasing proportion of elderly people with respective care requirements and within the total population stands against aging personnel and staff reduction in the field of health care where employees are exposed to high load factors. Health promotion interventions may be a possibility to improve work situations and behavior. METHODS: A systematic literature search is conducted in 32 databases limited to English and German publications since 1990. Moreover, internet-searches are performed and the reference lists of identified articles are scanned. The selection of literature was done by two reviewers independently according to inclusion and exclusion criteria. Data extraction and tables of evidence are verified by a second expert just like the assessment of risk of bias by means of the Cochrane Collaboration's tool. RESULTS: We identified eleven intervention studies and two systematic reviews. There were three randomized controlled trials (RCT) and one controlled trial without randomization (CCT) on the improvement of physical health, four RCT and two CCT on the improvement of psychological health and one RCT on both. Study duration ranged from four weeks to two years and the number of participants included from 20 to 345, with a median of 56. Interventions and populations were predominantly heterogeneous. In three studies intervention for the improvement of physical health resulted in less complaints and increased strength and flexibility with statistically significant differences between groups. Regarding psychological health interventions lead to significantly decreased intake of analgesics, better stress management, coping with workload, communication skills and advanced training. DISCUSSION: Taking into consideration the small to very small sample sizes, other methodological flaws like a high potential of bias and poor quality of reporting the validity of the results has to be considered as limited. Due to the heterogeneity of health interventions, study populations with differing job specializations and different lengths of study durations and follow-up periods, the comparison of results would not make sense. CONCLUSIONS: Further research is necessary with larger sample sizes, with a sufficient study duration and follow-up, with a lower risk of bias, by considering of relevant quality criteria and with better reporting in publications.

Prevention of alcohol misuse among children, youths and young adults.

BACKGROUND: Despite many activities to prevent risky alcohol consumption among adolescents and young adults there is an increase of alcohol intoxications in the group of ten to twenty year old juveniles. OBJECTIVES: This report gives an overview about the recent literature as well as the German federal prevention system regarding activities concerning behavioral and policy prevention of risky alcohol consumption among children, adolescents and young adults. Furthermore, effective components of prevention activities are identified and the efficiency and efficacy of ongoing prevention programs is evaluated. METHODS: A systematic literature review is done in 34 databases using Bool'sche combinations of the key words alcohol, prevention, treatment, children, adolescents and young adults. RESULTS: 401 studies were found and 59 studies were selected for the health technology assessment (HTA). Most of the studies are done in USA, nine in Germany. A family strengthening program, personalized computer based intervention at schools, colleges and universities, brief motivational interventions and policy elements like increase of prices and taxes proved effective. DISCUSSION: Among the 59 studies there are three meta-analyses, 15 reviews, 17 randomized controlled trials (RCT) and 18 cohort studies. Despite the overall high quality of the study design, many of them have methodological weaknesses (missing randomization, missing or too short follow-ups, not clearly defined measurement parameters). The transferability of US-results to the German context is problematic. Only a few prevention activities reach a sustainable reduction of frequency and/or amount of alcohol consumption. CONCLUSION: The HTA-report shows the need to develop specific and target group focused prevention activities for the German situation. Essential for that is the definition of target goals (reduction of consumption, change of behaviour) as well as the definition and empirical validation of risky alcohol consumption. The efficacy of prevention activities should be proven before they are launched. At present activities for the reduction or prevention of risky alcohol consumption are not sufficiently evaluated in Germany concerning their sustainable efficacy.

Informative value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA).

BACKGROUND: "Patient-Reported Outcome" (PRO) is used as an umbrella term for different concepts for measuring subjectively perceived health status e. g. as treatment effects. Their common characteristic is, that the appraisal of the health status is reported by the patient himself. In order to describe the informative value of PRO in Health Technology Assessment (HTA) first an overview of concepts, classifications and methods of measurement is given. The overview is complemented by an empirical analysis of clinical trials and HTA-reports on rheumatoid arthritis and breast cancer in order to report on type, frequency and consequences of PRO used in these documents. METHODS: For both issues systematic reviews of the literature have been performed. The search for methodological literature covers the publication period from 1990 to 2009, the search for clinical trials of rheumatoid arthritis and breast cancer covers the period 2005 to 2009. Both searches were performed in the medical databases of the German Institute of Medical Documentation and Information (DIMDI). The search for HTA-reports and methodological papers of HTA-agencies was performed in the CRD-Databases (CRD = Centre for Reviews and Dissemination) and by handsearching the websites of INAHTA member agencies (INAHTA = International Network of Agencies for Health Technology Assessment). For all issues specific inclusion and exclusion criteria were defined. The methodological quality of randomized controlled trials (RCT) was assessed by a modified version of the Cochrane Risk of Bias Tool. For the methodological part information extraction from the literature is structured by the report's chapters, for the empirical part data extraction sheets were constructed. All information is summarized in a qualitative manner. RESULTS: Concerning the methodological issues the literature search retrieved 158 documents (87 documents related to definition or classification, 125 documents related to operationalisation of PRO). For the empirical analyses 225 RCT (rheumatoid arthritis: 77; breast cancer: 148) and 40 HTA-reports and method papers were found. The analysis of the methodological literature confirms the role of PRO as an umbrella term for a variety of different concepts. The newest classification system facilitates the description of PRO measures by construct, target population and the method of measurement. Steps of operationalisation involve defining a conceptual framework, instrument development, exploration of measurement properties or, possibly, the modification of existing instruments. Seven out of 59 RCT analysing the effects of antibody therapy for rheumatoid arthritis define PRO as the primary endpoint, 38 trials utilize composite measures (ACR, DAS) and ten trials report clinical or radiological parameters as the primary endpoint. Six out of 123 chemotherapy trials for breast cancer define PRO as the primary endpoint, while 98 trials report clinical endpoints (survival, tumour response, progression) in their primary analyses. Discrepancies in the number of trials result from inaccurate specifications of endpoints in the publications. This distribution is reflected in the HTA-reports: while almost all reports on rheumatoid arthritis refer to PRO, this is only the case in about half of the reports on breast cancer. CONCLUSIONS: As definition and classification of PRO are concerned, coherent concepts are found in the literature. Their operationalisation and implementation must be guided by scientific principles. The type and frequency of PRO used in clinical trials largely depend on the disease analysed. The HTA-community seems to pursue the utilization of PRO proactively - in case of missing data the need for further research is stated.

Effectiveness of programmes as part of primary prevention demonstrated on the example of cardiovascular diseases and the metabolic syndrome.

BACKGROUND: The HTA-report (HTA = Health Technology Assessment) deals with the primary prevention of cardiovascular diseases and diabetes mellitus type 2. In 2009 approximately 356,000 people died in Germany due to cardiovascular diseases. According to estimations about 6.3 million people are suffering from diabetes mellitus type 2. The interventions that are subsidized by the public health insurance are mainly focused on sufficient physical activities, healthy nutrition, stress management and the reduction of the consumption of addictive drugs and luxury food. OBJECTIVES: Which lifestyle-related measures and/or programmes for primary prevention of cardiovascular diseases and of the metabolic syndrome are effective? To what extent will the health status be improved by these offers? To what extent will existing health resources and skills be strengthened by these offers? Are there any differences regarding the effectiveness among the interventions with respect to different settings or subgroups? Which lifestyle-related interventions and/or programmes for primary prevention of cardiovascular diseases and of the metabolic syndrome are sustainable and cost-effective? Which outcome parameters are in the view of the contributors decisive for the evaluation of the effectiveness? In the view of the contributor are there different values between the outcome parameters? In the view of the payers and other actors are there different values between the outcome parameters? Which ethical and juridical factors have to be considered? Which social and/or socio-economic parameters influence the use of the services and effectiveness? METHODS: A systematic literature research is done in 35 databases. For the period 2005 to 2010, reviews, epidemiological and clinical studies as well as economical evaluations which deal with primary prevention programmes regarding cardiovascular diseases or the metabolic syndrome are included. RESULTS: 44 publications meet the inclusion criteria. These studies confirm the effectiveness of the primary prevention programmes. Physical activity programs seem to have a stronger effect than nutrition programmes. Psychological programmes prove as well effectiveness, if they include cognitive behaviour therapy. The identified economical studies indicate that programmes for cardiovascular prevention can be conducted cost-effectively. Interventions that focus on the general population turn out to be particularly cost-effective and sustainable. DISCUSSION: There is a wide range of primary preventive effective lifestyle-related interventions with high evidence. The outcomes and results are consistent with the recommendations of the two identified evidence-based guidelines regarding the recommendations on lifestyle and healthy nutrition. Furthermore, the cost-effectiveness of primary prevention services is proven. With regard to the economical studies it is however worth noting that this result is based on very few publications. The transferability has to be critically assessed as the studies mainly originate from the American health system. CONCLUSION: On the whole a comprehensive setting approach with educative, somatic, psychosocial and activity therapeutic components is recommended. The sustainability of a prevention intervention must be ensured from programme to programme. Long-term studies are necessary to make valid statements regarding the sustainable effectiveness: There is an essential deficit in the current practiced evaluation of the use of primary prevention services provided by the health insurance - mainly regarding the comprehensive setting approach - regarding the evidence-based evaluation of the prescribed preventive interventions. With regard to the ethical, social and economical evaluation the research situation is deficient. The situation has to be particularly analyzed for the socially deprived and one has to respond to their specific needs for prevention.

Over-, under- and misuse of pain treatment in Germany.

BACKGROUND: The HTA-report (Health Technology Assessment) deals with over- and undertreatment of pain therapy. Especially in Germany chronic pain is a common reason for the loss of working hours and early retirement. In addition to a reduction in quality of life for the affected persons, chronic pain is therefore also an enormous economic burden for society. OBJECTIVES: Which diseases are in particular relevant regarding pain therapy?What is the social-medical care situation regarding pain facilities in Germany?What is the social-medical care situation in pain therapy when comparing on international level?Which effects, costs or cost-effects can be seen on the micro-, meso- and macro level with regard to pain therapy?Among which social-medical services in pain therapy is there is an over- or undertreatment with regard to the micro-, meso- and macro level?Which medical and organisational aspects that have an effect on the costs and/or cost-effectiveness have to be particularly taken into account with regard to pain treatment/chronic pain?What is the influence of the individual patient's needs (micro level) in different situations of pain (e. g. palliative situation) on the meso- and macro level?Which social-medical and ethical aspects for an adequate treatment of chronic pain on each level have to be specially taken into account?Is the consideration of these aspects appropriate to avoid over- or undertreatment?Are juridical questions included in every day care of chronic pain patients, mainly in palliative care?On which level can appropriate interventions prevent over- or undertreatment? METHODS: A systematic literature research is done in 35 databases. In the HTA, reviews, epidemiological and clinical studies and economic evaluations are included which report about pain therapy and in particular palliative care in the years 2005 till 2010. RESULTS: 47 studies meet the inclusion criteria. An undertreatment of acupuncture, over- and misuse with regard to opiate prescription and an overuse regarding unspecific chest pain and chronic low back pain (LBP) can be observed. The results show the benefit and the cost-effectiveness of interdisciplinary as well as multi-professional approaches, multimodal pain therapy and cross-sectoral integrated medical care. Only rough values can be determined about the care situation regarding the supply of pain therapeutic and palliative medical facilities as the data are completely insufficient. DISCUSSION: Due to the broad research question the HTA-report contains inevitably different outcomes and study designs which partially differ qualitatively very strong from each other. In the field of palliative care hospices for in-patients and palliative wards as well as hospices for out-patients are becoming more and more important. Palliative care is a basic right of all terminally ill persons. CONCLUSION: Despite the relatively high number of studies in Germany the HTA-report shows a massive lack in health care research. Based on the studies a further expansion of out-patient pain and palliative care is recommended. Further training for all involved professional groups must be improved. An independent empirical analysis is necessary to determine over or undertreatment in pain care.