Chilean consensus by expert panel using the Delphi technique for primary and secondary prevention of gastric cancer. / Estrategias para la prevención primaria y secundaria del cáncer gástrico: consenso chileno de panel de expertos con técnica Delfi.

INTRODUCTION: Gastric cancer (GC) is the first cause of cancer-related death in Chile and 6th in Latin America and the Caribbean (LAC). Helicobacter pylori (H. pylori) is the main gastric carcinogen, and its treatment reduces GC incidence and mortality. Esophageal-gastro-duodenoscopy (EGD) allows for the detection of premalignant conditions and early-stage GC. Mass screening programs for H. pylori infection and screening for premalignant conditions and early-stage GC are not currently implemented in LAC. The aim of this study is to establish recommendations for primary and secondary prevention of GC in asymptomatic standard-risk populations in Chile. METHODS: Two on-line synchronous workshops and a seminar were conducted with Chilean experts. A Delphi panel consensus was conducted over 2 rounds to achieve>80% agreement on proposed primary and secondary prevention strategies for the population stratified by age groups. RESULTS: 10, 12, and 12 experts participated in two workshops and a seminar, respectively. In the Delphi panel, 25 out of 37 experts (77.14%) and 28 out of 52 experts (53.85%) responded. For the population aged 16-34, there was no consensus on non-invasive testing and treatment for H. pylori, and the use of EGD was excluded. For the 35-44 age group, non-invasive testing and treatment for H. pylori is recommended, followed by subsequent test-of-cure using non-invasive tests (stool antigen test or urea breath test). In the ≥45 age group, a combined strategy is recommended, involving H. pylori testing and treatment plus non-invasive biomarkers (H. pylori IgG serology and serum pepsinogens I and II); subsequently, a selected group of subjects will undergo EGD with gastric biopsies (Sydney Protocol), which will be used to stratify surveillance according to the classification Operative Link for Gastritis Assessment (OLGA); every 3 years for OLGA III-IV and every 5 years for OLGA I-II. CONCLUSION: A "test-and-treat" strategy for H. pylori infection based on non-invasive studies (primary prevention) is proposed in the 35-44 age group, and a combined strategy (serology and EGD) is recommended for the ≥45 age group (primary and secondary prevention). These strategies are potentially applicable to other countries in LAC.

[Reduction in Helicobacter pylori infection among patients referred for upper gastrointestinal endoscopy in Santiago, Chile, between 2010-2020]. / Reducción de la infección por Helicobacter pylori en pacientes derivados a endoscopia digestiva alta en Santiago de Chile entre 2010-2020.

Latin America presents a high prevalence of Helicobacter pylori(Hp) infection. Between1996-2003, the prevalence in Santiago, Chile, was 70%; recent studies indicate a decreasein this infection. Updating the frequency of Hp is crucial due to its associated health impact. OBJECTIVE: Our objective was to describe the trend in Hp infection in patients undergoingambulatory esophagogastroduodenoscopy (EGD) in a Chilean population. MATERIALS AND METHODS: A retrospective observational study was conducted on patients over 18 years old who attended a first EGD with a rapid urease test between 2010-2020. Time trendswere described through time series analysis. A Poisson model was constructed to estimatethe risk of infection, adjusted for age and gender. RESULTS: 11,355 patients were included[66.9% females; mean age 52 years; Hp 41.6%]. Male gender presented a higher frequencyof Hp infection [RR 1.13; (95% CI: 1.08-1.18)].Hp frequency infection decreased significantlyfrom 45.1% in 2010 to 29% in 2020, with a 36% lower probability of Hp infection in 2020 compared to 2010 [RR 0.64;(95% CI: 0.55-0.74)]. A progressive decline in Hp infectiontrend was projected, reaching values close to 25% by year 2025. CONCLUSION: A significantreduction in Hpinfection was observed between 2010-2020. This decrease could be explained by the implementation of public health policies in the last decade associated with socio-sanitary changes.

The socioeconomic distribution of life expectancy and healthy life expectancy in Chile.

BACKGROUND: Life expectancy (LE) has usually been used as a metric to monitor population health. In the last few years, metrics such as Quality-Adjusted-Life-Expectancy (QALE) and Health-Adjusted-Life- Expectancy (HALE) have gained popularity in health research, given their capacity to capture health related quality of life, providing a more comprehensive approach to the health concept. We aimed to estimate the distribution of the LE, QALEs and HALEs across Socioeconomic Status in the Chilean population. METHODS: Based on life tables constructed using Chiang II´s method, we estimated the LE of the population in Chile by age strata. Probabilities of dying were estimated from mortality data obtained from national registries. Then, life tables were stratified into five socioeconomic quintiles, based on age-adjusted years of education (pre-school, early years to year 1, primary level, secondary level, technical or university). Quality weights (utilities) were estimated for age strata and SES, using the National Health Survey (ENS 2017). Utilities were calculated using the EQ-5D data of the ENS 2017 and the validated value set for Chile. We applied Sullivan´s method to adjust years lived and convert them into QALEs and HALEs. RESULTS: LE at birth for Chile was estimated in 80.4 years, which is consistent with demographic national data. QALE and HALE at birth were 69.8 and 62.4 respectively. Men are expected to live 6.1% less than women. However, this trend is reversed when looking at QALEs and HALEs, indicating the concentration of higher morbidity in women compared to men. The distribution of all these metrics across SES showed a clear gradient in favour of a better-off population-based on education quintiles. The absolute and relative gaps between the lowest and highest quintile were 15.24 years and 1.21 for LE; 18.57 HALYs and 1.38 for HALEs; and 21.92 QALYs and 1.41 for QALEs. More pronounced gradients and higher gaps were observed at younger age intervals. CONCLUSION: The distribution of LE, QALE and HALEs in Chile shows a clear gradient favouring better-off populations that decreases over people´s lives. Differences in LE favouring women contrast with differences in HALEs and QALEs which favour men, suggesting the need of implementing gender-focused policies to address the case-mix complexity. The magnitude of inequalities is greater than in other high-income countries and can be explained by structural social inequalities and inequalities in access to healthcare.

The social and health protection of migrants in Chile: qualitative analysis of civil society proposals for constitutional change.

BACKGROUND: A sustained period of social, economic, and political unrest took place during October of 2019 in Chile. As an institutional solution, the "Agreement for Social Peace and the New Constitution" was signed. In this document, most political parties committed to reestablishing peace and public order in Chile, agreeing on the initiation of a constitutional process. To promote participation of civil society actors, the "Popular Initiative for Norms" was enabled. This was a platform where civilians could submit proposals for constitutional norms to be discussed by the Constitutional Convention. We aimed to analyze proposals related to migrants and migrant health. METHODS: We conducted a qualitative thematic analysis of the proposals. Sixteen of them were related to migrants, and we analyzed their association to health. We also evaluated their link to the Health Goals 2030 set out by the Chilean Ministry of Health and the Global Action Plan 2019-2023 for Promoting the Health of Refugees and Migrants by the World Health Organization. RESULTS: Four main thematic categories were identified: 1) Humans rights of migrants, refugees, and asylum seekers; 2) Nationality and regularization of migrants and refugees; 3) Political participation and cultural integration of migrants and refugees; and 4) Specific regulations on slavery and human trafficking. These resonated with broader frameworks established in the Health Goals 2030 (Chile) and the Global Action Plan 2019-2023 for Promoting the Health of Refugees and Migrants by the World Health Organization. CONCLUSIONS: The 'Popular Initiative for Norms' was a non-binding participatory mechanism. Although the proposals sent through were not guaranteed to be included in the constitutional draft-and despite the final draft being rejected last September 2022-the platform allowed to gain insights into civilian opinions. Our findings showed that there is an incipient yet weak recognition of the rights and situation of migrants in Chile. There was no direct mention of health nor an explicit contemplation of social determinants of health. Despite there being an urgent need to define strategies for migrants' health in Chile, this study demonstrated that civil awareness and interest are still insufficient.

Economic evaluation of a multimorbidity patient centered care model implemented in the Chilean public health system.

Multimorbidity and patient-centered care approaches are growing challenges for health systems and patients. The cost of multimorbidity patients and the transition to a new care strategy is still sightly explored. In Chile, more than 70% of the adult population suffer from multimorbidity, opening an opportunity to implement a Multimorbidity patient-centered care model. The objective of this study was to perform an economic evaluation of the model from the public health system perspective.The methodology used a cost-consequence evaluation comparing seven exposed with seven unexposed primary care centers, and their reference hospitals. It followed three steps. First, we performed a Time-Driven Activity-Based Costing with routinely collected data routinely collected. Second, we run a comparative analysis through a propensity score matching and an estimation of the attributable costs to health services utilization at primary, secondary and tertiary care and health outcomes. Third, we estimated implementation and transaction costs.Results showed savings in aggregate costs of the total population (-0.12 (0.03) p < 0.01) during the period under evaluation. Costs in primary care showed a significant increase, whereas tertiary care showed significant savings. Health outcomes were associated with higher survival in patients under the new care model (HR 0.70 (0.05) p < 0.01). Implementation and transaction costs increased as the number of pilot intervention centers increased, and they represented 0,07% of the total annual budget of the Servicio de Salud Metropolitano Sur Oriente. After three years of piloting, the implementation and transaction cost for the total period was USD 1,838,767 and 393,775, respectively.The study's findings confirm the purpose of the new model to place primary health care at the center of care for people with non-communicable chronic diseases. Thus, it is necessary to consider implementation and transaction costs to introduce a broad health system multimorbidity approach. The health system should assume some of them permanently to guarantee sustainability and facilitate scale-up.

Real-world evidence: experiences and challenges for decision making in Latin America.

OBJECTIVE: The Health Technology Assessment (HTA) process aims to optimize health system funding of technologies. In recent years there has been an increase in what is known as Real-World Evidence (RWE) as a complement to clinical trials. The objective of Health Technology Assessment International's Latin American Policy Forum 2022 was to explore the utility of incorporating RWE into HTA and decision-making processes in the region. METHODS: This article is based on a background document, survey, and the deliberative work of the country representatives who participated in the Forum. RESULTS: There is a growing interest in the use of Real-World Data / Real-World Evidence in HTA processes in Latin America, although currently there are no specific local guidelines for RWE use by HTA agencies. At present, its use is limited to certain areas such as adding context to HTA reports, the evaluation of adverse events, or cost estimation.Potential future uses of RWE were identified, including the creation of risk-sharing agreements, the assessment of technology performance in routine practice, providing information on outcomes that are not so easily evaluated in clinical trials (e.g., the identification of specific subpopulations or quality of life), and the estimation of input parameters for economic evaluations. CONCLUSIONS: The participants agreed that there are several areas presenting significant potential to expand the application of RWD/RWE and that the development of normative frameworks for its use could be helpful.

Estimation of the demand for palliative care in non-oncologic patients in Chile.

BACKGROUND: Access to palliative care is an emerging global public health challenge. In Chile, a palliative care law was recently enacted to extend palliative care coverage to the non-oncologic population. Thus, a reliable and legitimate estimate of the demand for palliative care is needed for proper health policy planning. OBJECTIVE: To estimate the demand for Palliative Care in Chile. METHODOLOGY: Diseases likely to require palliative care were identified according to literature and expert judgement. Annual deaths of diseases identified were estimated for the periods 2018-2020. Demand estimation corresponds to the identification of the proportion of deceased patients requiring palliative care based on the burden of severe health-related suffering. Finally, patient-years were estimated based on the expected survival adjustment. RESULTS: The estimated demand for palliative care varies between 25,650 and 21,679 patients depending on the approximation used. In terms of annual demand, this varies between 1,442 and 10,964 patient-years. The estimated need has a minor variation between 2018 and 2019 of 0.85% on average, while 2020 shows a slightly higher decrease (7.26%). CONCLUSION: This is a replicable method for estimating the demand of palliative care in other jurisdictions. Future studies could approach the demand based on the decedent population and living one for a more precise estimation and better-informed health planning. It is hoped that our methodological approach will serve as an input for implementing the palliative care law in Chile, and as an example of estimating the demand for palliative care in other jurisdictions.

Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective.

In a multiday conference, a panel of Latin American experts in biological cancer therapies and health economics were provided with questions to address the barriers restricting access to biosimilars in Latin America, specifically for patients with breast cancer and colorectal cancer, for whom biosimilars can be a path forward to increasing access to care. During the conference, responses were discussed and edited until a consensus was achieved. The regulatory challenges identified in the conference included heterogenous regulations, non-adherence to regulatory pathways, scarcity of market opportunity, inadequate naming of biosimilars by only using international non-proprietary names, imprecise use of interchangeability and substitution, and insufficient traceability and pharmacovigilance. Recommendations were developed to improve the implementation of regulatory pathways and reliable procurement strategies that increase access to these therapies with adequate traceability and outcome measures; efforts from all involved stakeholders will be crucial. These recommendations can serve as a strategy for biosimilar adoption in other countries in a similar situation.

Reduced Immune Response to Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in a Cohort of Immunocompromised Patients in Chile.

BACKGROUND: Inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines have been widely implemented in low- and middle-income countries. However, immunogenicity in immunocompromised patients has not been established. Herein, we aimed to evaluate immune response to CoronaVac vaccine in these patients. METHODS: This prospective cohort study included 193 participants with 5 different immunocompromising conditions and 67 controls, receiving 2 doses of CoronaVac 8-12 weeks before enrollment. The study was conducted between May and August 2021, at Red de Salud UC-CHRISTUS, Santiago, Chile. Neutralizing antibody (NAb) positivity, total anti-SARS-CoV-2 immunoglobulin G antibody (TAb) concentrations, and T-cell responses were determined. RESULTS: NAb positivity and median neutralizing activity were 83.1% and 51.2% for the control group versus 20.6% and 5.7% (both P < .001) in the solid organ transplant group, 41.5% and 19.2% (both P < .0001) in the autoimmune rheumatic diseases group, 43.3% (P < .001) and 21.4% (P<.01 or P = .001) in the cancer with solid tumors group, 45.5% and 28.7% (both P < .001) in the human immunodeficiency virus (HIV) infection group, 64.3% and 56.6% (both differences not significant) in the hematopoietic stem cell transplant group, respectively. TAb seropositivity was also lower for the solid organ transplant (20.6%; P < .0001), rheumatic diseases (61%; P < .001), and HIV groups (70.9%; P = .003), compared with the control group (92.3%). On the other hand, the number of interferon γ spot-forming T cells specific for SARS-CoV-2 tended to be lower in all immunocompromising conditions but did not differ significantly between groups. CONCLUSIONS: Diverse immunocompromising conditions markedly reduce the humoral response to CoronaVac vaccine. These findings suggest that a boosting vaccination strategy should be considered in these vulnerable patients. CLINICAL TRIALS REGISTRATION: NCT04888793.

Health-related quality of life by household income in Chile: a concentration index decomposition analysis.

BACKGROUND: Health inequities have a profound impact on all dimensions of people's lives, with invariably worse results among the most disadvantaged, transforming them into a more fragile and vulnerable population. These unfair inequalities also affect dimensions focused on subjectivity, such as health-related quality of life (HRQoL), which has been positioned, in recent decades, as an important outcome in health decision-making. The main objective of this study is to estimate socioeconomic inequality in HRQoL of Chilean by household income.  METHODS: Secondary analysis of the National Health Survey (ENS 2016-2017, Chile). This survey includes a nationally representative, stratified, and multistage household sample of people aged 15 and above. Socioeconomic inequality in HRQoL (EQ5D) is estimated by the concentration index (CI) ranked by household income. Decomposition analysis is conducted to examine potential explanatory sociodemographic factors.  RESULTS: The CI for household income inequality in HRQoL was -0.063. The lower the household income, the worse the HRQoL reported by in Chile. The decomposition analysis revealed that socioeconomic position contributes 75,7% to inequality in the quality of life, followed by educational level (21.8%), female gender (17.3%), and type of Health Insurance (15%), age (-19.7%) and residence (-10.8%). Less than 1% corresponds to the unexplained residual component. CONCLUSIONS: Our findings suggest the existence of a disproportionate concentration of worse HRQoL in the most disadvantaged socioeconomic groups in Chile. This inequality is largely, yet not completely, associated with household income. Other significant factors associated with this inequality are education, gender, and healthcare insurance. These results suggest the need of strengthening efforts to reducing socioeconomic gaps in health outcomes in Chile, as a means to achieve social justice and equity in health and healthcare.

[The expected cost of cancer in Chile]. / El costo esperado de cáncer en Chile.

BACKGROUND: Cancer is a public health priority in Chile. AIM: To estimate the expected annual cost of cancer in Chile, due to direct costs of health services, working allowances and indirect costs for productivity losses. MATERIAL AND METHODS: We undertook an ascendent costing methodology to calculate direct costs. We built diagnostic, treatment and follow-up cost baskets for each cancer type. Further, we estimated the expenditure due to sick leave subsidies. Both estimates were performed either for the public or private sector. Costs related to productivity loss were estimated using the human capital approach, incorporating disease related absenteeism premature deaths. The time frame for all estimates was one year. RESULTS: The annual expected costs attributed to cancer was $1,557 billion of Chilean pesos. The health services expected annual costs were $1,436 billion, 67% of which are spent on five cancer groups (digestive, hematologic, respiratory, breast and urinary tract). The expected costs of sick leave subsidies and productivity loss were $48 and $71 billion, respectively. CONCLUSIONS: Cancer generates costs to the health system, which obliges health planners to allocate a significant proportion of the health budget to this disease. The expected costs estimated in this study are equivalent to 8.9% of all health expenditures and 0.69% of the Gross Domestic Product. This study provides an updated reference for future research, such as those aimed at evaluating the current health policies in cancer.

Early versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial.

BACKGROUND: Convalescent plasma (CP), despite limited evidence on its efficacy, is being widely used as a compassionate therapy for hospitalized patients with COVID-19. We aimed to evaluate the efficacy and safety of early CP therapy in COVID-19 progression. METHODS AND FINDINGS: The study was an open-label, single-center randomized clinical trial performed in an academic medical center in Santiago, Chile, from May 10, 2020, to July 18, 2020, with final follow-up until August 17, 2020. The trial included patients hospitalized within the first 7 days of COVID-19 symptom onset, presenting risk factors for illness progression and not on mechanical ventilation. The intervention consisted of immediate CP (early plasma group) versus no CP unless developing prespecified criteria of deterioration (deferred plasma group). Additional standard treatment was allowed in both arms. The primary outcome was a composite of mechanical ventilation, hospitalization for >14 days, or death. The key secondary outcomes included time to respiratory failure, days of mechanical ventilation, hospital length of stay, mortality at 30 days, and SARS-CoV-2 real-time PCR clearance rate. Of 58 randomized patients (mean age, 65.8 years; 50% male), 57 (98.3%) completed the trial. A total of 13 (43.3%) participants from the deferred group received plasma based on clinical aggravation. We failed to find benefit in the primary outcome (32.1% versus 33.3%, odds ratio [OR] 0.95, 95% CI 0.32-2.84, p > 0.999) in the early versus deferred CP group. The in-hospital mortality rate was 17.9% versus 6.7% (OR 3.04, 95% CI 0.54-17.17 p = 0.246), mechanical ventilation 17.9% versus 6.7% (OR 3.04, 95% CI 0.54-17.17, p = 0.246), and prolonged hospitalization 21.4% versus 30.0% (OR 0.64, 95% CI, 0.19-2.10, p = 0.554) in the early versus deferred CP group, respectively. The viral clearance rate on day 3 (26% versus 8%, p = 0.204) and day 7 (38% versus 19%, p = 0.374) did not differ between groups. Two patients experienced serious adverse events within 6 hours after plasma transfusion. The main limitation of this study is the lack of statistical power to detect a smaller but clinically relevant therapeutic effect of CP, as well as not having confirmed neutralizing antibodies in donor before plasma infusion. CONCLUSIONS: In the present study, we failed to find evidence of benefit in mortality, length of hospitalization, or mechanical ventilation requirement by immediate addition of CP therapy in the early stages of COVID-19 compared to its use only in case of patient deterioration. TRIAL REGISTRATION: NCT04375098.

Prevalence, burden of disease, and lost in health state utilities attributable to chronic musculoskeletal disorders and pain in Chile.

BACKGROUND: Musculoskeletal disorders are a leading cause of disability adjusted life years (DALY) in the world. We aim to describe the prevalence and to compare the DALYs and loss of health state utilities (LHSU) attributable to common musculoskeletal disorders in Chile. METHODS: We used data from the Chilean National Health Survey carried out in 2016-2017. Six musculoskeletal disorders were detected through the COPCOPRD questionnaire: chronic musculoskeletal pain, chronic low back pain, chronic shoulder pain, osteoarthritis of hip and knee, and fibromyalgia. We calculated the DALY for each disorder for 18 sex and age strata, and LHSU following an individual and population level approaches. We also calculated the fraction of LHSU attributable to pain. RESULTS: Chronic musculoskeletal pain disorder affects a fifth of the adult population, with a significant difference between sexes. Among specific musculoskeletal disorders highlights chronic low back pain with the highest prevalence. Musculoskeletal disorders are a significant cause of LHSU at the individual level, especially in the case of fibromyalgia. Chronic musculoskeletal pain caused 503,919 [283,940 - 815,132] DALYs in 2017, and roughly two hundred thousand LSHU at population level, which represents 9.7% [8.8-10.6] of the total LSHU occurred in that year. Discrepancy in the burden of musculoskeletal disorders was observed according to DALY or LSHU estimation. The pain and discomfort domain of LHSU accounted for around half of total LHSU in people with musculoskeletal disorders. CONCLUSION: Chronic musculoskeletal pain is a major source of burden and LHSU. Fibromyalgia should deserve more attention in future studies. Using the attributable fraction offers a straightforward and flexible way to explore the burden of musculoskeletal disorders.

Development of a checklist to guide equity considerations in health technology assessment.

OBJECTIVES: Health technology assessment (HTA) can impact health inequities by informing healthcare priority-setting decisions. This paper presents a novel checklist to guide HTA practitioners looking to include equity considerations in their work: the equity checklist for HTA (ECHTA). The list is pragmatically organized according to the generic HTA phases and can be consulted at each step. METHODS: A first set of items was based on the framework for equity in HTA developed by Culyer and Bombard. After rewording and reorganizing according to five HTA phases, they were complemented by elements emerging from a literature search. Consultations with method experts, decision makers, and stakeholders further refined the items. Further feedback was sought during a presentation of the tool at an international HTA conference. Lastly, the checklist was piloted through all five stages of an HTA. RESULTS: ECHTA proposes elements to be considered at each one of the five HTA phases: Scoping, Evaluation, Recommendations and Conclusions, Knowledge Translation and Implementation, and Reassessment. More than a simple checklist, the tool provides details and examples that guide the evaluators through an analysis in each phase. A pilot test is also presented, which demonstrates the ECHTA's usability and added value. CONCLUSIONS: ECHTA provides guidance for HTA evaluators wishing to ensure that their conclusions do not contribute to inequalities in health. Several points to build upon the current checklist will be addressed by a working group of experts, and further feedback is welcome from evaluators who have used the tool.

Acute Appendicitis in Children During the COVID-19 Pandemic: Neither Delayed Diagnosis Nor Worse Outcomes.

AIM: The aim of this study was to describe the incidence of complicated appendicitis during the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pandemic lockdown. METHODS: This was a retrospective study of pediatric patients diagnosed with acute appendicitis in a single pediatric institution that assumed care responsibility for most of the pediatric emergencies during the lockdown period in Madrid (Spain). A control group was made up of the same number of patients diagnosed the previous year. RESULTS: One hundred fifty-one patients diagnosed with acute appendicitis were included (77 during self-quarantine and 74 during the previous year). The incidence of complicated appendicitis was 38.9% versus 28.3%, showing no significant differences. The 2 groups were homogeneous, with no differences in time elapsed between symptom onset and first emergency department visit, laboratory test results, median length of stay, intensive care admissions, or patients correctly diagnosed on their first visit. CONCLUSIONS: COVID-19 (coronavirus disease 2019) self-quarantine has not increased the incidence of complicated appendicitis, and children who developed complicated appendicitis did not have worse clinical outcomes. Parents did not delay presenting for medical attention, and emergency department pediatricians did not fail to diagnose this condition. Reorganization of hospital resources, fast-track treatment protocols for noncomplicated appendicitis, and extended use of home-stay hospitalization for complicated appendicitis could have contributed to these favorable outcomes.

Real-World Evidence in Healthcare Decision Making: Global Trends and Case Studies From Latin America.

BACKGROUND: Real-world evidence (RWE) is increasingly used to inform health technology assessments for resource allocation, which are valuable tools for emerging economies such as in America. Nevertheless, the characteristics and uses in South America are unknown. OBJECTIVES: To identify sources, characteristics, and uses of RWE in Argentina, Brazil, Colombia, and Chile, and evaluate the context-specific challenges. The implications for future regulation and responsible management of RWE in the region are also considered. METHODS: A systematic literature review, database mapping, and targeted gray literature search were conducted to identify the sources and characteristics of RWE. Findings were validated by key opinion leaders attending workshops in 4 South American countries. RESULTS: A database mapping exercise revealed 407 unique databases. Geographic scope, database type, population, and outcomes captured were reported. Characteristics of national health information systems show efforts to collect interoperable data from service providers, insurers, and government agencies, but that initiatives are hampered by fragmentation, lack of stewardship, and resources. In South America, RWE is mainly used for pharmacovigilance and as pure academic research, but less so for health technology assessment decision making or pricing negotiations and not at all to inform early access schemes. CONCLUSIONS: The quality of real-world data in the case study countries vary and RWE is not consistently used in healthcare decision making. Authors recommend that future studies monitor the impact of digitalization and the potential effects of access to RWE on the quality of patient care.

Improving natural ventilation in hospital waiting and consulting rooms to reduce nosocomial tuberculosis transmission risk in a low resource setting.

BACKGROUND: TB transmission in healthcare facilities is an important public health problem, especially in the often-overcrowded settings of HIV treatment scale-up. The problem is compounded by the emergence of drug resistant TB. Natural ventilation is a low-cost environmental control measure for TB infection control where climate permits that is suited to many different areas in healthcare facilities. There are no published data on the effect of simple structural modifications to existing hospital infrastructure to improve natural ventilation and reduce the risk of nosocomial TB transmission. The purpose of this study was to measure the effect of simple architectural modifications to existing hospital waiting and consulting rooms in a low resource setting on (a) improving natural ventilation and (b) reducing modelled TB transmission risk. METHODS: Room ventilation was measured pre- and post-modification using a carbon dioxide tracer-gas technique in four waiting rooms and two consulting rooms in two hospitals in Lima, Peru. Modifications included additional windows for cross-ventilation (n = 2 rooms); removing glass from unopenable windows (n = 2); creation of an open skylight (n = 1); re-building a waiting-room in the open air (n = 1). Changes in TB transmission risk for waiting patients, or healthcare workers in consulting rooms, were estimated using mathematical modelling. RESULTS: As a result of the infrastructure modifications, room ventilation in the four waiting rooms increased from mean 5.5 to 15; 11 to 16; 10 to 17; and 9 to 66 air-changes/hour respectively; and in the two consulting rooms from mean 3.6 to 17; and 2.7 to 12 air-changes/hour respectively. There was a median 72% reduction (inter-quartile range 51-82%) in calculated TB transmission risk for healthcare workers or waiting patients. The modifications cost

Evaluation of the Health Assessment Questionnaire Disability Index in Chilean patients with rheumatoid arthritis.

BACKGROUND: The Health Assessment Questionnaire Disability Index (HAQDI) is one of the main instruments used to evaluate functional status in rheumatoid arthritis (RA). AIM: To assess the reliability and validity of the Spanish version of HAQDI in Chilean RA population. MATERIALS AND METHODS: The questionnaire was applied to 98 patients with RA aged 44 ± 12 years (90% women). Reliability was assessed using Cronbach's alpha statistic for internal consistency. Construct validity was assessed by comparing total HAQDI value and eight HAQDI domains with multiple parameters of disease activity. Discriminant validity was evaluated by classifying disease activity in low, medium or high and evaluating HAQDI value in each category. Floor and ceiling effects were evaluated. To assess construct validity, principal components analysis was performed using varimax rotation. RESULTS: There were no issues in the comprehensibility of the questionnaire. Mean HAQDI score was 1.57 ± 0.66. Standardized Cronbach's Alpha was 0.883. Correlations between Chilean HAQ domains had a p value less than 0.001, and values ranged from 0.317 to 0.597. Activity parameters, DAS 28 and CDAI were significantly correlated with HAQDI domains. Mean HAQDI values were 0.98 ± 0.59,1.45 ± 0.57, and 1.90 ± 0.56 for mild, moderate and severe disease activity. A principal components analysis identified two factors that accounted for 70.0% of total variability. CONCLUSIONS: This study shows that the Spanish version of HAQDI is reliable and valid and can be used in Chilean patients with RA.

Critical Analysis of Markov Models Used for the Economic Evaluation of Colorectal Cancer Screening: A Systematic Review.

BACKGROUND: The economic evaluation of colorectal cancer screening is challenging because of the need to model the underlying unobservable natural history of the disease. OBJECTIVES: To describe the available Markov models and to critically analyze their main structural assumptions. METHODS: A systematic search was performed in eight relevant databases (MEDLINE, Embase, Econlit, National Health Service Economic Evaluation Database, Health Economic Evaluations Database, Health Technology Assessment database, Cost-Effective Analysis Registry, and European Network of Health Economics Evaluation Databases), identifying 34 models that met the inclusion criteria. A comparative analysis of model structure and parameterization was conducted using two checklists and guidelines for cost-effectiveness screening models. RESULTS: Two modeling techniques were identified. One strategy used a Markov model to reproduce the natural history of the disease and an overlaying model that reproduced the screening process, whereas the other used a single model to represent a screening program. Most of the studies included only adenoma-carcinoma sequences, a few included de novo cancer, and none included the serrated pathway. Parameterization of adenoma dwell time, sojourn time, and surveillance differed between studies, and there was a lack of validation and statistical calibration against local epidemiological data. Most of the studies analyzed failed to perform an adequate literature review and synthesis of diagnostic accuracy properties of the screening tests modeled. CONCLUSIONS: Several strategies to model colorectal cancer screening have been developed, but many challenges remain to adequately represent the natural history of the disease and the screening process. Structural uncertainty analysis could be a useful strategy for understanding the impact of the assumptions of different models on cost-effectiveness results.

Social value and individual choice: The value of a choice-based decision-making process in a collectively funded health system.

Evidence about cost-effectiveness is increasingly being used to inform decisions about the funding of new technologies that are usually implemented as guidelines from centralized decision-making bodies. However, there is also an increasing recognition for the role of patients in determining their preferred treatment option. This paper presents a method to estimate the value of implementing a choice-based decision process using the cost-effectiveness analysis toolbox. This value is estimated for 3 alternative scenarios. First, it compares centralized decisions, based on population average cost-effectiveness, against a decision process based on patient choice. Second, it compares centralized decision based on patients' subgroups versus an individual choice-based decision process. Third, it compares a centralized process based on average cost-effectiveness against a choice-based process where patients choose according to a different measure of outcome to that used by the centralized decision maker. The methods are applied to a case study for the management of acute coronary syndrome. It is concluded that implementing a choice-based process of treatment allocation may be an option in collectively funded health systems. However, its value will depend on the specific health problem and the social values considered relevant to the health system.