Pre-surgical factors related to latent trajectories of 5-year weight loss for a diverse bariatric surgery population.

BACKGROUND: Analyzing trajectories of weight loss may address how particular groups of patients respond to metabolic and bariatric surgery. OBJECTIVES: The Bariatric Experience Long Term (BELONG) study was designed to use a theoretical model to examine determinants of weight loss and recurrence. SETTING: Large integrated health system in Southern California with 11 surgical practices and 23 surgeons. METHODS: A total of n = 1338 patients who had metabolic and bariatric surgery were surveyed before surgery to measure factors related to median percent total weight loss (%TWL) over 5 years. Longitudinal weight data were available for n = 1024 (76.5% of the sample). Data were analyzed using latent growth mixture models (GMM) to estimate trajectories of weight change separately for gastric sleeve and bypass operations. These trajectories were then described using relevant variables from the baseline survey. RESULTS: For both gastric sleeve (n = 733) and bypass (n = 291) operations, 3 latent trajectories of median %TWL were found corresponding to most, moderate, and least %TWL. Sleeve trajectories were distinguished by body mass index at surgery and geocoded environmental factors. Bypass trajectories varied by self-reported and geocoded environmental factors, comorbidity burden, race, experiential avoidance, and weight control strategies. CONCLUSIONS: Future research should examine the role of the built and perceived environment in surgical weight loss. Bariatric practices should focus less on the presurgical period for predictors of long-term weight loss and begin efforts to monitor real-time patient-reported outcomes to help tailor intervention strategies for patients who either do not lose an expected amount of weight or who begin to experience weight recurrence.

Baseline Psychosocial, Environmental, Health, and Behavioral Correlates of 1- and 3-Year Weight Loss After Bariatric Surgery.

PURPOSE: Weight loss surgery is an effective, long-term treatment for severe obesity but individual response to surgery varies widely. The purpose of this study was to test a comprehensive theoretical model of factors that may be correlated with the greatest surgical weight loss at 1-3 years following surgery. Such a model would help determine what predictive factors to measure when patients are preparing for surgery that may ensure the best weight outcomes. MATERIALS AND METHODS: The Bariatric Experience Long Term (BELONG) study collected self-reported and medical record-based baseline information as correlates of 1- and 3-year % total weight loss (TWL) in n = 1341 patients. Multiple linear regression was used to determine the associations between 120 baseline variables and %TWL. RESULTS: Participants were 43.4 ± 11.3 years old, Hispanic or Black (52%; n = 699), women (86%; n = 1149), and partnered (72%; n = 965) and had annual incomes of ≥ $51,000 (60%; n = 803). A total of 1006 (75%) had 3-year follow-up weight. Regression models accounted for 10.1% of the variance in %TWL at 1-year and 13.6% at 3 years. Only bariatric operation accounted for a clinically meaningful difference (~ 5%) in %TWL at 1-year. At 3 years after surgery, only bariatric operation, Black race, and BMI ≥ 50 kg/m2 were associated with clinically meaningful differences in %TWL. CONCLUSIONS: Our findings combined with many others support a move away from extensive screening and selection of patients at the time of surgery to a focus on improving access to this treatment.

Neighborhood deprivation and residential property values do not affect weight loss at 1 or 3 years after bariatric surgery.

OBJECTIVE: This study examined the association between individual- and neighborhood-level sociodemographic factors and surgical weight loss at 1 year (short term) and 3 years (long term). METHODS: Data were obtained from the baseline survey of the BELONG (Bariatric Experience Long Term) prospective longitudinal cohort study. Individual-level self-reported data on sex, race and ethnicity, education, and household income were obtained by survey. Data from the 2010 US Census were used to calculate area Neighborhood Deprivation Index score and median value of owner-occupied housing units at the census tract level. RESULTS: Patients (N = 1341) had a mean age of 43.4 (SD 11.3) years, were mostly female (86%), were mostly Black or Hispanic (52%), had some college education (83%), and had annual household incomes ≥$51,000 (55%). Percentage total weight loss was 25.8% (SD 9.0%) at year 1 and 22.2% (SD 10.5%) at year 3. Race and ethnicity and age were significant predictors of weight loss at 1 and 3 years with a small effect of self-reported household income at year 1. There were no significant associations between census tract-level Neighborhood Deprivation Index score or value of owner-occupied housing units and weight loss at either time point. CONCLUSIONS: Health systems could improve the chances of weight-loss maintenance after surgery by addressing factors related to racial and ethnic disparities and to income disparities.

Cost-Effectiveness of the CNIC-Polypill Strategy Compared With Separate Monocomponents in Secondary Prevention of Cardiovascular and Cerebrovascular Disease in Portugal: The MERCURY Study.

Background: Cardiovascular (CV) diseases remain a leading and costly cause of death globally. Patients with previous CV events are at high risk of recurrence. Secondary prevention therapies improve CV risk factor control and reduce disease costs. Objectives: To assess the cost-effectiveness of a CV polypill strategy (CNIC-Polypill) compared with the loose combination of monocomponents to improve the control of CV risk factors in patients with previous coronary heart disease or stroke. Methods: A Markov model cost-utility analysis was developed using 4 health states, SMART risk equation, and 3-month cycles for year 1 and annual cycles thereafter, over a lifetime horizon from the perspective of the National Health System in Portugal (base case). The NEPTUNO study, Portuguese registries, mortality tables, official reports, and the literature were consulted to define effectiveness, epidemiological costs, and utility data. Outcomes were costs (estimated in 2020 euros) per life-year (LY) and quality-adjusted LY (QALY) gained. A 4% discount rate was applied. Alternative scenarios and one-way and probabilistic sensitivity analyses tested the consistency and robustness of results. Results: The CNIC-Polypill strategy in secondary prevention provides more LY and QALY, at a higher cost, than monocomponents. The incremental cost-utility ratio is €1557/QALY gained. Assuming a willingness-to-pay threshold of €30 000/QALY gained, there is a 79.7% and a 44.4% probability of the CNIC-Polypill being cost-effective and cost-saving, respectively, compared with the loose combination of monocomponents. Results remain consistent in the alternative scenarios and robust in the sensitivity analyses. Discussion: The model reflects increments in the number of years patients would live and in quality of life with the CNIC-Polypill. The clinical effectiveness of the CNIC-Polypill strategy initially demonstrated in the NEPTUNO study has been recently corroborated in the SECURE trial. The incremental cost of the CNIC-Polypill strategy emerges slightly above the comparator, but willingness-to-pay estimates and sensitivity analyses indicate that the CNIC-Polypill strategy is consistently cost-effective compared with monocomponents and remains within acceptable affordability margins. Conclusion: The CNIC-Polypill is a cost-effective secondary prevention strategy. In patients with histories of coronary heart disease or stroke, the CNIC-Polypill more effectively controls CV risk factors compared with monocomponents.

The association of 1-year weight loss from bariatric surgery and self-reported sleep: a prospective cohort.

OBJECTIVE: This study examined the association of weight loss following bariatric surgery with self-reported sleep quality after accounting for other sleep-related factors. METHODS: Participants were from the Bariatric Experience Long Term (BELONG) study. Participants completed a survey up to 6 months before surgery and approximately 1 year after surgery. The Pittsburgh Sleep Quality Index (PSQI) was used to measure sleep quality. One-year percentage total weight loss (%TWL) was determined from electronic medical records. Covariates included demographics, Charlson Comorbidity Index, geocoded variables to assess neighborhood quality, and physical activity. The authors assessed the association between %TWL at 1 year and PSQI component scores with separate cumulative logit models. RESULTS: There were 997 participants in the analytic cohort. Participants were 86.2% women, 37.0% Hispanic, and 13.7% Black adults. Mean one-year %TWL was 26.3 (SD 8.7). Each 1% increase in %TWL was associated with a 3% better daytime dysfunction score (odds ratio = 1.03; 95% CI: 1.02-1.05) and a 2% better sleep quality score (odds ratio = 1.02; 95% CI: 1.00-1.03). No significant differences were found for the other PSQI components. CONCLUSIONS: Weight loss from bariatric surgery was associated with better self-reported sleep at 1 year. For people undergoing bariatric surgery, there may be an added benefit of better sleep.

Cohort profile: The Bariatric Experience Long Term (BELONG): a long-term prospective study to understand the psychosocial, environmental, health and behavioural predictors of weight loss and regain in patients who have bariatric surgery.

PURPOSE: The Bariatric Experience Long Term (BELONG) prospective study cohort was created to address limitations in the literature regarding the relationship between surgical weight loss and psychosocial, health, behaviour and environmental factors. The BELONG cohort is unique because it contains 70% gastric sleeve and 64% patients with non-white race/ethnicity and was developed with strong stakeholder engagement including patients and providers. PARTICIPANTS: The BELONG cohort study included 1975 patients preparing to have bariatric surgery who completed a baseline survey in a large integrated health system in Southern California. Patients were primarily women (84%), either black or Hispanic (59%), with a body mass index (BMI) of 45.1±7.4 kg/m2, age 43.3±11.5 years old, and 32% had at least one comorbidity. FINDINGS TO DATE: A total of 5552 patients were approached before surgery between February 2016 and May 2017, and 1975 (42%) completed a baseline survey. A total of 1203 (73%) patients completed the year 1 and 1033 (74%) patients completed the year 3 postoperative survey. Of these survey respondents, 1341 at baseline, 999 at year 1, and 951 at year 3 were included in the analyses of all survey and weight outcome data. A total of 803 (60% of eligible patients) had survey data for all time points. Data collected were self-reported constructs to support the proposed theoretical model. Height, weight and BMI were abstracted from the electronic medical record to obtain the main outcomes of the study: weight loss and regain. FUTURE PLANS: We will collect self-reported constructs and obtain height, weight and BMI from the electronic medical record 5 years after bariatric surgery between April 2022 and January 2023. We will also collect patient experiences using focus groups of 8-12 patients each throughout 2022.

Bariatric Surgical Alterations in Tolerability, Enjoyment and Cravings in the Diet (BSATED) instrument: A new scale to measure food preferences following bariatric surgery.

Bariatric surgery is associated with changing food preferences, but it is not known whether these changes differ by type of operation or are associated with weight loss. The current study presents validation results for a new 27-item scale, Bariatric Surgical Alterations in Tolerability, Enjoyment and Cravings in the Diet (BSATED). This scale measured enjoyment, craving, and intolerance changes for nine food and beverage categories common to dietary habits in the Southern California region of the U.S. one year following bariatric surgery in the Bariatric Experience Long Term (BELONG) study. Validation of BSATED was done using exploratory factor analyses, construct validity with other conceptually related survey instruments, and criterion validity using hypothesized differences for operation type and percent total weight loss (%TWL) at 12-18 months after surgery. Participants (n = 999) were 86% female, 41% non-Hispanic White, with a mean age of 43.1 ± 11.3 years and a body mass index (BMI) of 43.4 ± 6.8 kg/m2 at the time of surgery. Participants reported less enjoyment and craving for high-fat meats (62%), grains (54%), candy and other desserts (e.g. candy bars, chocolate, ice cream) (52%), and sweet baked goods (48%) 12 months after surgery. These changes were more common among participants undergoing Roux-en-Y gastric bypass (RYGB) compared to those receiving sleeve gastrectomy (SG). Participants who reported decreased enjoyment and craving for foods and beverages that post-bariatric patients are counseled to reduce or avoid had greater %TWL at 12-18 months following surgery (p < .001 and p = .003 respectively). The foods and beverages in BSATED that post-bariatric patients are counseled to reduce or avoid could be used to understand how changes in enjoyment, craving and tolerability of these foods/beverages contribute to weight loss following surgery.

The Bariatric Experience Long Term (BELONG): Factors Related to Having Bariatric Surgery in a Large Integrated Healthcare System.

PURPOSE: Bariatric surgery is the most effective treatment for severe obesity, but currently, only 1-2% of all eligible patients undergo surgery each year. This study examined which factors were associated with a patient receiving bariatric surgery after referral in a real-world healthcare setting. MATERIALS AND METHODS: The current study used the baseline survey and electronic medical record (EMR) data from the Bariatric Experience Long Term (BELONG) study (n = 1975). Predictors of who did (n = 1680) and who did not (n = 295) have surgery were analyzed using multivariate logistic regression. RESULTS: Participants (n = 1975; 42.4% response rate) were primarily women (84%) and either non-Hispanic Black or Hispanic (60%). In the fully adjusted multivariate model, the strongest predictors of having surgery were being a woman (OR = 3.17; 95% CI = 2.15, 4.68; p < .001) and losing at least 5% of their body weight in the year before surgery (OR = 3.16; 95% CI = 2.28, 4.38; p < .001). The strongest predictors of not having surgery were a ≥ BMI 50 kg/m2 (OR = .39; 95% CI = .27, .56; p < .001) and having a higher physical comorbidity burden (OR = .84; 95% CI = .75, .94; p = .004). CONCLUSIONS: Practices such as 5-10% total weight loss before surgery and selection of patients with safer operative risk profiles (younger with lower comorbidity burden) may inadvertently contribute to under-utilization of bariatric surgery among some demographic subpopulations who could most benefit from this intervention.

Do new cancer drugs offer good value for money? The perspectives of oncologists, health care policy makers, patients, and the general population.

BACKGROUND: In oncology, establishing the value of new cancer treatments is challenging. A clear definition of the different perspectives regarding the drivers of innovation in oncology is required to enable new cancer treatments to be properly rewarded for the value they create. The aim of this study was to analyze the views of oncologists, health care policy makers, patients, and the general population regarding the value of new cancer treatments. METHODS: An exploratory and qualitative study was conducted through structured interviews to assess participants' attitudes toward cost and outcomes of cancer drugs. First, the participants were asked to indicate the minimum survival benefit that a new treatment should have to be funded by the Spanish National Health System (NHS). Second, the participants were requested to state the highest cost that the NHS could afford for a medication that increases a patient's quality of life (QoL) by twofold with no changes in survival. The responses were used to calculate incremental cost-effectiveness ratios (ICERs). RESULTS: The minimum improvement in patient survival means that justified inclusions into the NHS were 5.7, 8.2, 9.1, and 10.4 months, which implied different ICERs for oncologists (€106,000/quality-adjusted life year [QALY]), patients (€73,520/QALY), the general population (€66,074/QALY), and health care policy makers (€57,471/QALY), respectively. The costs stated in the QoL-enhancing scenario were €33,167, €30,200, €26,000, and €17,040, which resulted in ICERs of €82,917/QALY for patients, €75,500/QALY for the general population, €65,000/QALY for oncologists, and €42,600/QALY for health care policy makers, respectively. CONCLUSION: All estimated ICER values were higher than the thresholds previously described in the literature. Oncologists most valued gains in survival, whereas patients assigned a higher monetary value to treatments that enhanced QoL. Health care policy makers were less likely to pay more for therapeutic improvements compared to the remaining participants.

Incidence of hepatocellular carcinoma in hepatitis C cirrhotic patients with and without HIV infection: a cohort study, 1999-2011.

INTRODUCTION. High activity antiretroviral therapy (HAART) has allowed people infected with human immunodeficiency virus (HIV) to live longer. In the course of time, hepatocellular carcinoma (HCC) began to be found in these patients. Investigations have suggested that, as it has been described for other tumors, HIV infection raises the risk of developing HCC. However, convincing evidence is still required. Our aim was to quantify the incidence of HCC in hepatitis C cirrhotic patients with and without human immunodeficiency virus infection in the HAART era. MATERIAL AND METHOds. This prospective cohort study was conducted in hepatitis C cirrhotic patients with and without HIV co-infection, between june 1, 1999 and May 21, 2010. Ultrasound screening for HCC was performed every 6 to 12 months to all the patients until January 15, 2011. Incidence rate and cumulative incidence (Kaplan-Meier) were calculated. RESULTS. One hundred and forty eight patients (69 hepatitis C virus mono-infected and 79 HIV/hepatitis C virus co-infected) were followed for a median time of 43 months, with a total follow-up of 555 person-years (324 for co-infected and 231 for mono-infected patients). Twelve patients developed HCC (5 co-infected and 7 mono-infected). The incidence of HCC in co-infected patients and mono-infected patients was 1.54 (95% confidence interval = 0.5 to 3.6) and 3.03 (95% confidence interval = 1.22 to 6.23) cases per 100 person-year respectively (log-rank p = 0.3225). CONCLUSION. In the HAART era, HIV co-infection is not associated with a higher incidence of HCC in hepatitis C cirrhotic patients.

Seguridad de abatacept en pacientes con artritis reumatoidea / Safety of abatacept in patients with rheumatoid arthritis

Abatacept (ABA) es una proteína de fusión que inhibe la señal coestimulatoria del linfocito T y está indicado en pacientes con artritis reumatoidea (AR) y artritis crónica juvenil moderada a severa sin respuesta a metotrexato (MTX). ABA ha demostrado su eficacia y seguridad en numerosos estudios controlados, doble ciego, randomizados en poblaciones seleccionadas. La incidencia de eventos adversos en estos estudios oscila entre 80 y 400 por 100 pacientes año. El objetivo del presente estudio fue evaluar la seguridad de ABA en pacientes con AR no seleccionados de la vida real. Material y métodos: Se incluyeron en forma consecutiva todos los pacientes con AR (criterios ACR'87) de 4 centros de reumatología que hubieran recibido al menos 1 dosis de ABA. Se consignaron datos socio-demográficos, características clínicas de la enfermedad, número de infusiones, dosis, y medicación concomitante. Se evaluaron todos los eventos adversos y se determinó la severidad y causalidad. Se consideraron las causas de suspensión del tratamiento. Análisis estadístico: Se evaluó la incidencia de eventos adversos/100 pacientes año de tratamiento, las variables categóricas fueron comparadas por Chi cuadrado y las continuas por test de Student o ANOVA...

Abatacept (ABA) is a fusion protein that inhibits the T cell costimulatorysignal and is indicated in patients with moderate to severe RheumatoidArthritis (RA) and Juvenil Idiopathic Arthritis, not responding to methotrexate. ABA has demonstrated eficacy and security in severalcontrolled, double-blind, randomized studies in selected populations.The objective of the present study was to evaluate security of ABA in patients with RA in the real life. Material and Methods: Consecutive patients with RA (ACR´87 classification) from 4 rheumatology centers that received at least one infusion of ABA were included. Socio-demographic data, disease characteristics, number of infusions, dosis, and concomitant medicationswere registered. All Adverse Events (AE) were evaluated and severityand causality were determined. Causes of treatment discontinuationwas also considered.Statistical analysis: Incidence of AE per 100 patient-years was evaluated, categorical variables were compared by Chi2 and continuous variables by Student T-test or ANOVA. Results: 184 patients were included, 155 (84.2%) were female, median age was 56 years (IQR 48-64) and median duration of disease was 13 years (IQR 8-18). 94.7% of the patients were rheumatoidfactor-positive and 82% had erosive disease. 90% were treatedwith concomitant DMARDs, methotrexate being the most frequent(76.5%). In 67% of the patients ABA was the first biologic agent used, and 23% had previously received at least one anti-TNF. Median duration of treatment with ABA was 24 months (IQR 11-34) and median number of infusions was 23 (IQR 10-34). Incidence of all AE was 46.18 per 100 patient-years, being the more frequents: Infections (27.3 per 100 patient-years), and infusion reactions (8.6 per100 patient-years)...

The use of quality-adjusted life-years in the economic evaluation of health technologies in Spain: a review of the 1990-2009 literature.

OBJECTIVE: To appraise economic evaluations of health technologies that included quality-adjusted life-years (QALYs) as an outcome measure conducted over the past 20 years in Spain. METHODS: A systematic review of the literature was conducted. Economic evaluations that included QALYs as an outcome measure, conducted in Spain and published between January 1990 and December 2009 were identified. Primary and gray literature sources were reviewed. RESULTS: A total of 60 articles and 4 health technology assessment reports were included. Key findings were 1) the vast majority of articles (77.1%) referred to therapeutic interventions; 2) 63.2% dealt with pharmaceutical products and much fewer with preventive strategies, medical devices, or diagnostic interventions; 3) most evaluations referred to cardiovascular- (19.8%), respiratory- (16.3%), and cancer- (13.0%) related processes; 4) 80.3% were based on a theoretical model, most commonly Markov models (71.4%); 5) 67.3% adopted the National Health System perspective; 6) information on the methods used to describe the health states was given in 45.1% of studies; 7) 40.3% used the EuroQoL-5D to elicit preferences, whereas 66.1% gave no details on the methods applied to determine patients' choices; 8) it was possible to state who completed the questionnaires in only 17.7% of studies; 9) 77.1% of the interventions assessed were below the €30,000/QALY suggested affordable threshold in Spain. CONCLUSIONS: An increasing number of economic evaluations using QALYs had been conducted. Most of them relied on theoretical models. Several methodological issues remain unsolved. Great disparity exists regarding the reporting of the methods used to determine health states and utility values.

Catalonia WHO palliative care demonstration project at 15 Years (2005).

Since 1990, a wide range of palliative care services has been implemented throughout the Catalan Health Care System. In 2005, 21,400 patients received palliative care; 59% had cancer (79.4% of all cancer patients) and 41% had other noncancer diagnoses (25.0%-56.5% of all noncancer patients). Today, more than 95% of Catalonia is covered by palliative care services. Fourteen districts have comprehensive palliative care networks. A total of 140 full-time physicians work in 183 specialty programs, including 63 palliative care units (with a total of 552 beds), 34 hospital consult teams, 70 home care teams, 16 outpatient clinics, and specialized pediatric and HIV/AIDS consult teams. Opioid consumption increased from 3.5mg per capita in 1989 to 21 mg per capita population in 2004. The cost of the specialist palliative care network is more than 40 million Euros annually. However, the cost efficiency is striking. Due to the radical change in the use of acute and emergency beds, the project saves the Catalan Health Care System an estimated 48 million Euros annually, a net savings of 8 million Euros annually. Additional preliminary data suggest that symptom control and patient/family satisfaction are both improved by these services.

El autocuidado de la salud en el personal de enfermería / The self medication of the health in the personnel of infirmary

La presente investigación tiene como objetivo principal determinar el nivel de autocuidado de la salud de las enfermeras de áreas cerradas en el Hospital José M. Penna, durante el mes de julio de 2005. El tipo de estudio realizado fue comparativo representativo, con corte transversal.

Public palliative care: review of key developments and implementation issues.

PURPOSE OF REVIEW: This review identifies and briefly describes palliative care programmes that are integrated into the national or regional health care plans of various countries. RECENT FINDINGS: The uneven development of palliative care in clear favour of developed countries, together with the menace that the growing epidemics of cancer and HIV/AIDS represent to the developing world, have heightened interest in promoting integration of palliative care into public health care strategies. Several successful examples exist in Asia, Africa, Europe, Australia and North America, which may serve as sources of expertise for new initiatives. SUMMARY: Success in making palliative care a public discipline that is fully integrated into a country's health care system requires considerable effort in terms of advocacy and lobbying. International support from and networking with experienced individuals who are involved in more mature programmes is crucial to changing attitudes and transforming ideas into action, and strategic and sustainable plans.

Palliative care research protocols: a special case for ethical review?

Between October 2001 and May 2002 the Chairperson and Vice-Chairperson of each Multicentre Research Ethics Committee (MREC) in England, Wales and Scotland took part in a semi-structured interview to ascertain the attitudes of MRECs to palliative care research. Interviews were transcribed and analysed using a grounded theory approach. Most respondents said each protocol was reviewed on its own merits, according to broad ethical principles, but were equivocal as to whether palliative care protocols posed particular or different challenges compared to those from other specialties. Respondents said they reviewed only a small number of palliative care protocols, and that they were less experienced with some of the study methods utilized, particularly qualitative designs. Four main themes emerged from the analysis. Respondents expressed concerns about the protocol itself--in regard to safeguarding the principles of autonomy and justice. There were concerns about how the research would be carried out, especially the protection of patients and the influence and input of the researcher in the process. The third theme concerned the impact of the research on the participant, particularly intrusion, potential distress and the existence of support mechanisms. Fourthly, respondents identified patient groups receiving palliative care (children, the elderly, bereaved families, patients in intensive therapy units, and those from ethnic groupings), who they considered might be particularly vulnerable.