Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison.

Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice.

Associations between the stringency of COVID-19 containment policies and health service disruptions in 10 countries.

BACKGROUND: Disruptions in essential health services during the COVID-19 pandemic have been reported in several countries. Yet, patterns in health service disruption according to country responses remain unclear. In this paper, we investigate associations between the stringency of COVID-19 containment policies and disruptions in 31 health services in 10 low- middle- and high-income countries in 2020. METHODS: Using routine health information systems and administrative data from 10 countries (Chile, Ethiopia, Ghana, Haiti, Lao People's Democratic Republic, Mexico, Nepal, South Africa, South Korea, and Thailand) we estimated health service disruptions for the period of April to December 2020 by dividing monthly service provision at national levels by the average service provision in the 15 months pre-COVID (January 2019-March 2020). We used the Oxford COVID-19 Government Response Tracker (OxCGRT) index and multi-level linear regression analyses to assess associations between the stringency of restrictions and health service disruptions over nine months. We extended the analysis by examining associations between 11 individual containment or closure policies and health service disruptions. Models were adjusted for COVID caseload, health service category and country GDP and included robust standard errors. FINDINGS: Chronic disease care was among the most affected services. Regression analyses revealed that a 10% increase in the mean stringency index was associated with a 3.3 percentage-point (95% CI -3.9, -2.7) reduction in relative service volumes. Among individual policies, curfews, and the presence of a state of emergency, had the largest coefficients and were associated with 14.1 (95% CI -19.6, 8.7) and 10.7 (95% CI -12.7, -8.7) percentage-point lower relative service volumes, respectively. In contrast, number of COVID-19 cases in 2020 was not associated with health service disruptions in any model. CONCLUSIONS: Although containment policies were crucial in reducing COVID-19 mortality in many contexts, it is important to consider the indirect effects of these restrictions. Strategies to improve the resilience of health systems should be designed to ensure that populations can continue accessing essential health care despite the presence of containment policies during future infectious disease outbreaks.

The Neglected Problem of Obesity during Pregnancy in Mexico: Secondary Data Analysis of the 2018 National Survey of Health and Nutrition.

OBJECTIVES: To compare sociodemographic and clinical characteristics among obese and non-obese women in Mexico and analyze the association between obesity and pregnancy complications. METHODS: We conducted a secondary data analysis of the 2018-2019 Mexican National Survey of Health and Nutrition. We included women aged 20-49 years who had at least one live birth in the five years preceding the survey (n = 1573). We performed a double-weighted (by IP-weights and survey-weights) multilevel multiple logistic regression analysis. RESULTS: Obesity was prevalent in 32% of pregnant women. Obese and non-obese women received similar antenatal care. 42.6% of obese women, compared to 33.6% of non-obese had one or more pregnancy or labor complications. Compared with non-obese women, obese women were older and had more chronic diseases. Obesity was associated with a 48% increase in the probability of complications. CONCLUSION: Due to the high prevalence of obesity among Mexican women of reproductive age and given the independent association between obesity and complications during pregnancy and labor, the development and implementation of specific clinical guidelines on weight management before conception, during pregnancy, and post-partum for women who are obese is an unmet need in Mexico.

Tracking health system performance in times of crisis using routine health data: lessons learned from a multicountry consortium.

COVID-19 has prompted the use of readily available administrative data to track health system performance in times of crisis and to monitor disruptions in essential healthcare services. In this commentary we describe our experience working with these data and lessons learned across countries. Since April 2020, the Quality Evidence for Health System Transformation (QuEST) network has used administrative data and routine health information systems (RHIS) to assess health system performance during COVID-19 in Chile, Ethiopia, Ghana, Haiti, Lao People's Democratic Republic, Mexico, Nepal, South Africa, Republic of Korea and Thailand. We compiled a large set of indicators related to common health conditions for the purpose of multicountry comparisons. The study compiled 73 indicators. A total of 43% of the indicators compiled pertained to reproductive, maternal, newborn and child health (RMNCH). Only 12% of the indicators were related to hypertension, diabetes or cancer care. We also found few indicators related to mental health services and outcomes within these data systems. Moreover, 72% of the indicators compiled were related to volume of services delivered, 18% to health outcomes and only 10% to the quality of processes of care. While several datasets were complete or near-complete censuses of all health facilities in the country, others excluded some facility types or population groups. In some countries, RHIS did not capture services delivered through non-visit or nonconventional care during COVID-19, such as telemedicine. We propose the following recommendations to improve the analysis of administrative and RHIS data to track health system performance in times of crisis: ensure the scope of health conditions covered is aligned with the burden of disease, increase the number of indicators related to quality of care and health outcomes; incorporate data on nonconventional care such as telehealth; continue improving data quality and expand reporting from private sector facilities; move towards collecting patient-level data through electronic health records to facilitate quality-of-care assessment and equity analyses; implement more resilient and standardized health information technologies; reduce delays and loosen restrictions for researchers to access the data; complement routine data with patient-reported data; and employ mixed methods to better understand the underlying causes of service disruptions.

Patients and nursing-related factors associated with switching from peritoneal dialysis to hemodialysis: A cross-sectional survey.

The study aimed at analyzing patients and nursing-related factors associated with switching from peritoneal dialysis to hemodialysis. A telephone survey with 574 patients receiving care at six peritoneal dialysis centers of the Mexican Institute of Social Security was conducted: 64.3% were on peritoneal dialysis, and 35.7% had transitioned from peritoneal dialysis to hemodialysis. Data were collected on participants' sociodemographic and clinical characteristics, peritoneal dialysis center size, and nursing workload. Descriptive, bivariate, and multiple Poisson regression analyses were performed. Factors associated with an increased probability of switching from peritoneal dialysis to hemodialysis were a history of catheter dysfunction, peritonitis, and being treated in a large peritoneal dialysis center with a low (<50 patients per nurse per month) or high nursing workload (>70 patients per nurse per month) located in the State of Mexico, compared to a medium-size peritoneal dialysis center with a moderate workload (50-70 patients per nurse per month). To decrease the odds of switching from peritoneal dialysis to hemodialysis, improvement programs should aim to limit nurses' workload to 50-70 patients per nurse per month and implement evidence-based nursing interventions to prevent, detect, and manage peritonitis and peritoneal catheter dysfunction.

Validation of the health literacy scale in patients with hypertension in Mexico.

INTRODUCTION: Health literacy integrates skills around health care. The measurement of health literacy is relevant for proposing improvement interventions. The European HLS-EU-Q16 scale allows to comprehensively evaluate health literacy, but its psychometric properties have not been assessed in Mexico. OBJECTIVE: To validate the HLS-EU-Q16 scale in patients with hypertension in Mexico. METHODS: A validation study of a measuring instrument was carried out. The construct was evaluated by means of factor analysis; internal consistency, using Cronbach's alpha; and test-retest reliability, using intraclass correlation coefficient (ICC). The information was collected by interviewing 349 patients with hypertension in a family medicine unit of the Mexican Institute of Social Security, from April to June 2022. RESULTS: In 23.8% of the patients, health literacy was inadequate; in 44.4%, problematic; and in 31.8%, sufficient. The scale was found to retain 12 items and two factors (HLS-EU-Q12M). Cronbach's alpha was 0.83, and ICC was 0.94. CONCLUSION: The HLS-EU-Q12M scale in Mexican Spanish is a valid instrument for assessing health literacy in adults with hypertension.

ANTECEDENTES: La alfabetización en salud integra las habilidades en torno al cuidado de la salud. La medición de la alfabetización en salud es relevante para proponer intervenciones de mejora. La escala europea HLS-EU-Q16 permite evaluar la alfabetización en salud de forma integral, pero sus propiedades psicométricas no se han evaluado en México. OBJETIVO: Validar la escala HLS-EU-Q16 en pacientes con hipertensión en México. MATERIAL Y MÉTODOS: Se realizó estudio de validación de un instrumento de medición. El constructo se evaluó mediante análisis factorial, la consistencia interna mediante alfa de Cronbach y la confiabilidad prueba-reprueba mediante coeficiente de correlación intraclase (CCI). La información fue recolectada mediante entrevistas a 349 pacientes con hipertensión en una unidad de medicina familiar del Instituto Mexicano del Seguro Social, de abril a junio de 2022. RESULTADOS: El 23.8 % de los pacientes tuvo una alfabetización en salud inadecuada; 44.4 %, problemática; y 31.8 %, suficiente. Se encontró que la escala está conformada por 12 reactivos y dos factores (HLS-EU-Q12M). El alfa de Cronbach fue de 0.83 y el CCI, de 0.94. CONCLUSIÓN: La escala HLS-EU-Q12M es un instrumento válido en español de México para evaluar la alfabetización en salud en adultos con hipertensión arterial.

Data sources for drug utilization research in Latin American countries-A cross-national study: DASDUR-LATAM study.

PURPOSE: Drug utilization research (DUR) contributes to inform policymaking and to strengthen health systems. The availability of data sources is the first step for conducting DUR. However, documents that systematize these data sources in Latin American (LatAm) countries are not known. We compiled the potential data sources for DUR in the LatAm region. METHODS: A network of DUR experts from nine LatAm countries was assembled and experts conducted: (i) a website search of the government, academic, and private health institutions; (ii) screening of eligible data sources, and (iii) liaising with national experts in pharmacoepidemiology (via an online survey). The data sources were characterized by accessibility, geographic granularity, setting, sector of the data, sources and type of the data. Descriptive analyses were performed. RESULTS: We identified 125 data sources for DUR in nine LatAm countries. Thirty-eight (30%) of them were publicly and conveniently available; 89 (71%) were accessible with limitations, and 18 (14%) were not accessible or lacked clear rules for data access. From the 125 data sources, 76 (61%) were from the public sector only; 46 (37%) were from pharmacy records; 43 (34%) came from ambulatory settings and; 85 (68%) gave access to individual patient-level data. CONCLUSIONS: Although multiple sources for DUR are available in LatAm countries, the accessibility is a major challenge. The procedures for accessing DUR data should be transparent, feasible, affordable, and protocol-driven. This inventory could permit a comparison of drug utilization between countries identifying potential medication-related problems that need further exploration.

Association of supportive care needs and quality of patient-centered cancer care with depression in women with breast and cervical cancer in Mexico.

OBJECTIVE: To compare the prevalence of depression, supportive care needs (SC-needs), and quality of patient-centered cancer care (PCC-quality) between women with breast cancer and women with cervical cancer and to assess the association of SC-needs and PCC-quality with depression. METHODS: We conducted a cross-sectional survey in a public oncology hospital in Mexico City with 247 breast cancer and 165 cervical cancer ambulatory patients aged ≥18 years with at least one hospitalization and ≤5 years since diagnosis. Participants completed the short-form Supportive Care Needs Survey, the Patient-Centered Quality of Cancer Care Questionnaire, and the Hospital Anxiety and Depression Scale. We performed multiple logistic regression analyses to evaluate the association between SC-needs, PCC-quality, and probable presence of depression. RESULTS: Nearly all women reported SC-needs-mainly health system and information needs, followed by physical and psychological needs. PCC-quality was substandard in both groups. PCC-quality was lowest when addressing biopsychosocial needs, followed by information for treatment decision-making needs. Cervical cancer patients had probable depression more often (41.2%) than those with breast cancer (29.5%). Having unmet psychological and care needs was associated with increased odds of probable depression, while high-quality timely care was associated with reduced odds of probable depression. CONCLUSION: In Mexico, women with cervical and breast cancer face unmet SC-needs, probable depression, and substandard PCC-quality, pointing to priority areas for improvements in cancer care.

The effects of professional continuous glucose monitoring as an adjuvant educational tool for improving glycemic control in patients with type 2 diabetes.

BACKGROUND: The study objective was to evaluate the effects of professional continuous glucose monitoring (CGM) as an adjuvant educational tool for improving glycemic control in patients with type 2 diabetes (T2D). METHODS: We conducted a three-month quasi-experimental study with an intervention (IGr) and control group (CGr) and ex-ante and ex-post evaluations in one family medicine clinic in Mexico City. Participants were T2D patients with HbA1c > 8% attending a comprehensive diabetes care program. In addition to the program, the IGr wore a professional CGM sensor (iPro™2) during the first 7 days of the study. Following this period, IGr participants had a medical consultation for the CGM results and treatment adjustments. Additionally, they received an educational session and personalized diet plan from a dietitian. After 3 months, the IGr again wore the CGM sensor for 1 week. The primary outcome variable was HbA1c level measured at baseline and 3 months after the CGM intervention. We analyzed the effect of the intervention on HbA1c levels by estimating the differences-in-differences treatment effect (Diff-in-Diff). Additionally, baseline and three-month CGM and dietary information were recorded for the IGr and analyzed using the Student's paired t-test and mixed-effects generalized linear models to control for patients' baseline characteristics. RESULTS: Overall, 302 T2D patients participated in the study (IGr, n = 150; control, n = 152). At the end of the three-month follow-up, we observed 0.439 mean HbA1C difference between groups (p = 0.004), with an additional decrease in HbA1c levels in the IGr compared with the CGr (Diff-in-Diff HbA1c mean of - 0.481% points, p = 0.023). Moreover, compared with the baseline, the three-month CGM patterns showed a significant increase in the percentage of time in glucose range (+ 7.25; p = 0.011); a reduction in the percentage of time above 180 mg/dl (- 6.01; p = 0.045), a decrease in glycemic variability (- 3.94, p = 0.034); and improvements in dietary patterns, shown by a reduction in total caloric intake (- 197.66 Kcal/day; p = 0.0001). CONCLUSION: Professional CGM contributes to reducing HbA1c levels and is an adjuvant educational tool that can improve glycemic control in patients with T2D. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04667728 . Registered 16/12/2020.

Social inequalities in supportive care needs and quality of patient-centered care of cancer patients in Mexico.

PURPOSE: To evaluate educational and health insurance-related inequalities in supportive care (SC) needs and quality of patient-centered care (PCC) for cancer patients in Mexico. METHODS: We conducted a cross-sectional survey in one Mexican Institute of Social Security (IMSS) and one Ministry of Health (MoH) oncology hospital in Mexico City. Formal labor market workers and their families have access to social health insurance that IMSS provides, while unemployed and informal workers receive care at the MoH. The study population comprised breast, colorectal, prostate, and hematologic cancer patients, aged ≥ 18 years, who attended outpatient consultations. Patients responded a short-form SC-needs questionnaire and a quality of PCC questionnaire. We used multiple logistic regression models to determine the independent association between educational attainment and high SC-needs and quality of PCC after controlling for sociodemographic and clinical covariates. RESULTS: We included 1058 IMSS and 606 MoH cancer patients. MoH patients perceived higher SC-needs and lower quality of PCC than IMSS patients. MoH patients with low education had a greater probability of high psychological and health system SC needs and lower likelihood of being informed for treatment decision-making and care for their biopsychosocial needs. IMSS patients with low educational levels had lower probability of receiving timely care and clarity of information than those with high education. Receiving high-quality PCC was associated with decreased SC needs. CONCLUSION: Uninsured cancer patients with low educational attainment have higher SC-needs and receive lower quality of PCC than their counterparts. Health services should face these challenges to reduce inequalities in Mexico.

Self-identity, lived experiences, and challenges of breast, cervical, and prostate cancer survivorship in Mexico: a qualitative study.

BACKGROUND: Qualitative research on cancer patients' survivor-identity and lived experiences in low- and middle-income countries is scarce. Our study aimed at exploring the concept and experience of survivorship for Mexicans living with breast, cervical, and prostate cancer. METHODS: We conducted a qualitative study in Mexico City, Morelos, Nuevo León, and Puebla. The participants were breast, cervical, and prostate cancer patients ≥18 years of age with completed primary cancer treatment. Data were collected via in-depth interviews and analyzed using an inductive thematic approach. RESULTS: The study included 22 participants with a history of breast, 20 cervical, and 18 prostate cancer. Participants accepted the term "cancer survivor" as a literal interpretation of being alive, medical confirmation of treatment completion, or achievement of a clinical result possibly indicative of cure. The majority of respondents perceived that the future is out of their control and under God's will. They linked cure to divine intervention and did not demonstrate the sense of empowerment that is often associated with the survivorship term. The principal themes of their narratives encompass: 1) adverse physical and sexual experiences; 2) emotional problems; 3) cancer-related stigma; 4) challenges to obtaining health-related information; 5) financial hardship; and 6) experience of strengthening family ties in order to provide them with support. In addition, women with breast cancer reported distress caused by changes in body image and positive experience with support groups. CONCLUSION: In Mexico, cancer patients report complex survivorship experiences that demand post-treatment follow-up and support. There is the need to implement comprehensive, culturally-relevant survivorship programs focused on emotional, informational, and in-kind support and empowerment of cancer patients.

Patient and health service factors associated with delays in cancer treatment for children without social security in Mexico.

BACKGROUND: The objective was to investigate factors associated with patient-related timing (PRT) to seek healthcare and health service-related timing (HSRT) to diagnose cancer and provide treatment to children without social security in Mexico. PROCEDURE: A cross-sectional survey was conducted in 13 Ministry of Health hospitals in the states of Chihuahua, Jalisco, Mexico City, Morelos, Oaxaca, Puebla, Queretaro, State of Mexico, and Tlaxcala. Study participants were parents of recently diagnosed pediatric cancer patients (≤ 17 years of age). Three groups of factors were investigated: (1) patients (child and parent characteristics); (2) healthcare providers (HCPs) (first-contact HCP, institution, perceptions of barriers to healthcare, etc.); and (3) disease factors (cancer type/site, stage/risk at diagnosis). PRT and HSRT-associated factors were identified using multiple negative binomial regressions. RESULTS: The study included 265 children; 49% sought care when symptoms first appeared. The median PRT was seven days, and the median HSRT was 40 days. Parents' perceptions of long wait times for appointments were associated with longer PRT and HSRT. Residing in the lowest or highest socioeconomic regions and persistent or worsening symptoms increased the probability of longer PRT. Older patient age, HCP requests for imaging tests or prescription for steroids, a higher number of doctors consulted, having a urinary tract cancer, and having an advanced stage or high-risk cancer increased the probability of longer HSRT. CONCLUSION: Strategies to shorten lag time from symptom onset to diagnosis and treatment are urgently needed for childhood cancers in Mexico.

Experiences with health care and health-related quality of life of patients with hematologic malignancies in Mexico.

BACKGROUND: In Mexico, patients with hematologic malignancies (HMs) are characterized by being at high risk and advanced stages at diagnosis and by having a low cure rate; yet information on their experiences with health care and health-related quality of life (HRQL) is scarce. We aimed to evaluate experiences with health care and HRQL of patients with HMs and the association between these patient-reported measures. METHODS: We conducted a cross-sectional survey in two public oncology hospitals in Mexico City. The study included outpatient cancer patients aged ≥18 years with a diagnosis of leukemia, lymphoma, or multiple myeloma. We used a patient-centered quality of cancer care questionnaire to assess patient experiences with receiving 1) timely care; 2) clear information; 3) information for treatment decision-making; 4) care to address biopsychosocial needs; and 5) respectful and coordinated care. We applied the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) to measure HRQL. We performed a multiple linear regression to evaluate the association between patient-reported experiences (independent variables) and the QLQ-C30 summary score (dependent variable). RESULTS: Of the 515 participating HM patients, 46.6% had lymphoma, 34% leukemia, and 19.4% multiple myeloma; 70.9% were at advanced stages or at high risk. Additionally, 15.1% had anxiety and 12.8% had depression. Over one third (35.9%) reported receiving clear information, 28.5% timely care, 20.6% information for treatment decision-making, 23.7% care that addressed their biopsychosocial needs, and 31% respectful and coordinated care. The mean QLQ-C30 summary score was 71.9 points. Timely care, clear information, and care that addresses biopsychosocial needs were associated with higher HRQL. CONCLUSIONS: Health care services for HM patients at public oncology hospitals in Mexico need improvement. Notably, providing timely care, clear information, and care that addresses patients' biopsychosocial needs can increase the likelihood of better HRQL. Health care providers should measure and improve the experiences of HM patients with health care.

Gaps between supply and demand of acute myocardial infarction treatment in Mexico.

OBJECTIVE: To analyze acute myocardial infarction (AMI) admissions and in-hospital mortality rates and evaluate the competence of the Ministry of Health (MOH) hospitals to provide AMI treatment. MATERIALS AND METHODS: We used a mixed-methods approach: 1) Joinpoint analysis of hos-pitalizations and in-hospital mortality trends between 2005 and 2017; 2) a nation-wide cross-sectional MOH hospital survey. RESULTS: AMI hospitalizations are increasing among men and patients aged >60 years; women have higher mortal-ity rates. The survey included 527 hospitals (2nd level =471; 3rdlevel =56). We identified insufficient competence to diagnose AMI (2nd level 37%, 3rd level 51%), perform pharmacological perfusion (2nd level 8.7%, 3rd level 26.8%), and mechanical reperfusion (2nd level 2.8%, 3rd level 17.9%). CONCLUSIONS: There are wide disparities in demand, supply, and health outcomes of AMI in Mexico. It is advisable to build up the competence with gender and age perspectives in order to di-agnose and manage AMI and reduce AMI mortality effectively.

OBJETIVO: Analizar las tendencias de admisiones y mortali-dad hospitalaria por infarto agudo al miocardio (IAM) y eva-luar la competencia hospitalaria de la Secretaría de Salud (SS) para tratarlo. MATERIAL Y MÉTODOS: Enfoque de métodos mixtos: Jointpoint análisis de tendencias de hospitalizaciones y mortalidad hospitalaria entre 2005 y 2017, y encuesta en hospitales de la SS. RESULTADOS: Las hospitalizaciones por IAM están aumentando entre hombres y pacientes >60 años. Las mujeres tienen mayor mortalidad. La encuesta incluyó 527 hospitales (2º nivel =471, 3er nivel =56). Los hospitales tienen competencias insuficientes para diagnosticar IAM (2º nivel 37%, 3er nivel 51%), realizar perfusión farmacológica (2º nivel 8.7%, 3er nivel 26.8%) y reperfusión mecánica (2º nivel 2.8%, 3er nivel 17.9%). CONCLUSIONES: Existen disparidades en demanda, oferta y resultados en salud del IAM. Es aconsejable fortalecer las competencias, con perspectivas de género y edad, para diagnosticar y tratar IAM, y reducir su mortalidad efectivamente.

Cost-effectiveness of the use of the continuous subcutaneous insulin infusion pump versus daily multiple injections in type 1 diabetes adult patients at the Mexican Institute of Social Security.

BACKGROUND: To estimate the incremental cost-effectiveness ratio (ICER) of the use of continuous subcutaneous insulin infusion (CSII) therapy versus multiple daily injections (MDI) therapy in adult patients with type 1 diabetes (T1D) at the Mexican Institute of Social Security (IMSS). METHODS: An analysis was developed using the internationally validated Core Diabetes Model (CDM) with which the incidence and progression of acute and chronic complications and the mortality of T1D was simulated throughout life. The baseline characteristics of the simulated cohorts were obtained from Mexican T1D adult patients aged ≥ 18 years that received care at two national IMSS medical centres in 2016. In the base case, the costs of the complications and treatment of the disease with both therapies were estimated in Mexican currency from the perspective of the institution, using Diagnosis Related Groups for outpatient and inpatient care. Utilities were taken from the international bibliography. In a secondary analysis, indirect costs were included using a human capital approach. The model used a lifetime time horizon, and a discount rate of 5% was applied for health outcomes and costs. A one-way sensitivity analysis was conducted on key variables and patient sub-groups; uncertainty was evaluated using a Cost-Effectiveness Acceptability Curve. RESULTS: The average age of the cohort was 32 years, with diabetes duration of 19 years, an average HbA1c of 9.2%; 29% were men. A gain of 0.614 Quality Adjusted Life Years (QALYs) was estimated with the use of CSII therapy. The estimated ICER was MXN$478,020 per QALY in the base case, and MXN$369,593 when indirect costs were considered. The sensitivity analysis showed that, in adult patients with HbA1c > 9.0%, the ICER was MXN$262,237. CONCLUSIONS: This is the first economic evaluation study that compares CSII therapy versus MDI therapy for T1D adult patients in Mexico. The insulin pump therapy can be considered cost-effective in the context of the IMSS when considering a threshold of three GDPs per capita with 43.9% probability. Results improve substantially when patients have an HbA1c above 9%.

User experience and satisfaction with specialty consultations and surgical care in secondary and tertiary level hospitals in Mexico.

BACKGROUND: To evaluate the association between user experience and satisfaction with specialty consultations and surgical care at the Mexican Institute of Social Security (IMSS) secondary and tertiary level hospitals. METHODS: We conducted secondary data analysis of the cross-sectional 2017 IMSS National Satisfaction Survey. The dependent variables were user satisfaction with outpatient consultation and with surgery. The study's independent variables were user experience with these services. The Lancet Global Health Commission on High Quality Health Systems in the Sustainable Development Era framework was used to guide the analysis. For each dependent variable a double-weighted Poisson regression model with robust variance was performed and considered clustering of the observations within 111 secondary level and 25 tertiary level hospitals. RESULTS: The study included 6713 outpatient consultation users and 528 surgery users. 83% of users attending outpatient consultations and 86.6% of users who underwent inpatient surgery at IMSS hospitals were satisfied with the service received. The common patient negative experiences with specialty consultations and surgical care were long waiting time (40%) and lack of hospital cleanliness (20%). An additional concern was the lack of clinical examination during the consultation (25%). Shorter waiting times, health provider courtesy, good communication, clinical examination, and hospital cleanliness were associated with patient satisfaction with specialty consultations. Having the surgery without prior postponement(s) and without complications increased the probability of patient satisfaction. CONCLUSION: Patient satisfaction with hospital outpatient consultations and surgical care may be raised by focusing on improvement strategies to enhance positive patient experiences with care.

Application of machine learning methodology to assess the performance of DIABETIMSS program for patients with type 2 diabetes in family medicine clinics in Mexico.

BACKGROUND: The study aimed to assess the performance of a multidisciplinary-team diabetes care program called DIABETIMSS on glycemic control of type 2 diabetes (T2D) patients, by using available observational patient data and machine-learning-based targeted learning methods. METHODS: We analyzed electronic health records and laboratory databases from the year 2012 to 2016 of T2D patients from six family medicine clinics (FMCs) delivering the DIABETIMSS program, and five FMCs providing routine care. All FMCs belong to the Mexican Institute of Social Security and are in Mexico City and the State of Mexico. The primary outcome was glycemic control. The study covariates included: patient sex, age, anthropometric data, history of glycemic control, diabetic complications and comorbidity. We measured the effects of DIABETIMSS program through 1) simple unadjusted mean differences; 2) adjusted via standard logistic regression and 3) adjusted via targeted machine learning. We treated the data as a serial cross-sectional study, conducted a standard principal components analysis to explore the distribution of covariates among clinics, and performed regression tree on data transformed to use the prediction model to identify patient sub-groups in whom the program was most successful. To explore the robustness of the machine learning approaches, we conducted a set of simulations and the sensitivity analysis with process-of-care indicators as possible confounders. RESULTS: The study included 78,894 T2D patients, from which 37,767patients received care through DIABETIMSS. The impact of DIABETIMSS ranged, among clinics, from 2 to 8% improvement in glycemic control, with an overall (pooled) estimate of 5% improvement. T2D patients with fewer complications have more significant benefit from DIABETIMSS than those with more complications. At the FMC's delivering the conventional model the predicted impacts were like what was observed empirically in the DIABETIMSS clinics. The sensitivity analysis did not change the overall estimate average across clinics. CONCLUSIONS: DIABETIMSS program had a small, but significant increase in glycemic control. The use of machine learning methods yields both population-level effects and pinpoints the sub-groups of patients the program benefits the most. These methods exploit the potential of routine observational patient data within complex healthcare systems to inform decision-makers.

Adequate health literacy is associated with better health outcomes in people with type 2 diabetes in Mexico.

This study evaluates the health literacy of people with type 2 diabetes and its association with health outcomes. We conducted a cross-sectional survey in two family medicine clinics of the Mexican Institute of Social Security that included 778 diabetic patients >19 years of age. The Spanish version of the European Health Literacy questionnaire served to measure health literacy. Multiple logistic regressions were performed to determine the association between the independent variable (health literacy) and dependent variables (good self-rated health, glycemic control, and diabetes-related hospitalizations) after controlling for conceptually relevant patient's characteristics. Only 17.6% of patients had adequate health literacy; while, the remaining percentage showed inadequate (23%), or problematic (59.4%) health literacy. After adjusting for the patients' characteristics, those with adequate health literacy had 4.66 (95%CI: 2.26-9.61) times the odds of good self-rated health compared to those with inadequate literacy. Patients with adequate health literacy had 0.65 (95%CI: 0.49-0.86) times the odds of hospitalization due to diabetes compared to those with inadequate literacy. Compared to inadequate health literacy, problematic literacy was associated with increased odds of glycemic control. In conclusion, healthcare providers should actively address the health literacy needs of patients to increase good self-rated health, glucose control and reduce hospitalizations.

QUALITY OF HEALTH CARE AND VIRAL SUPPRESSION AMONG HUMAN IMMUNODEFICIENCY VIRUS PATIENTS.

BACKGROUND: In Mexico, the quality of health care for human immunodeficiency virus (HIV) patients is unknown. The study objectives were to develop quality of care (QoC) indicators for outpatient care of HIV patients, evaluate the quality of the processes of care (QPC) and outcomes, and analyze the association between the QPC and viral suppression among HIV patients. METHODS: The study used a mixed-methods approach: (1) Development of QoC indicators through RAND/UCLA method; (2) cross-sectional study of QoC evaluation; and (3) multiple Poisson regressions to measure the association between the QPC and viral suppression. The study included 439 HIV patients, ≥ 19 years of age, with at least one outpatient consultation during 2017 at a public hospital in the State of Mexico. RESULTS: We developed 21 QoC indicators to evaluate HIV care. Based on these indicators, the QoC gaps that emerged were related to clinical history (24% of patient records included sexual history information), routine adherence assessment (no records demonstrated regular recording of antiretroviral treatment adherence), and screening and referral (50% were screened for depression, and 42% for tuberculosis; 1.2% of patients with abnormal body mass index were referred to a dietitian). On average, HIV patients received 63% of recommended QPC; 77.7% achieved viral suppression. Receiving over 75% of recommended QPC was associated with a higher probability of viral suppression (adjusted prevalence ratio 1.13, 95% confidence interval 1.03-1.24). CONCLUSIONS: Evaluation of the QoC for HIV patients is essential to identify and address gaps in health-care quality to increase the probability of viral suppression.

[Prevalencia de complicaciones de la diabetes y comorbilidades asociadas en medicina familiar del Instituto Mexicano del Seguro Social].

Introduction: The prevalence of chronic complications and comorbidities in patients with type 2 diabetes (T2D) has increased worldwide. Objective: To compare the prevalence of complications and chronic comorbidities in patients with T2D at 36 family medicine units of five chapters of the Mexican Institute of Social Security (IMSS). Method: Complications (hypoglycemia, diabetic foot, kidney disease, retinopathy, ischemic heart disease, cerebrovascular disease and heart failure) and comorbidities (liver disease, cancer and anemia) were identified according to codes of the International Classification of Diseases, 10th Revision. Comparisons were made by chapter, age, gender and evolution time. Results: Complications and comorbidities were more common in subjects aged ≥ 62 years. Out of 297 100 patients, 34.9 % had any complication; microvascular complications (32 %) prevailed in the industrial North, whereas macrovascular complications (12.3 %) did in the rural East, and comorbidities (5 %) in southern Mexico City. Complications predominated in men (any complication, 30.2 %). Heart failure and comorbidities were more common in women (5.6 % and 4.9 %, respectively). Conclusions: T2D complications and comorbidities showed geographic and gender differences, and were greater with older age and longer evolution time. It is urgent for strategies for the prevention of complications and comorbidities to be reinforced in patients with T2D.

Introducción: La prevalencia de complicaciones crónicas y comorbilidades en pacientes con diabetes tipo 2 (DT2) se han incrementado en el mundo. Objetivo: Comparar la prevalencia de complicaciones y comorbilidades crónicas en pacientes con DT2 en 36 unidades de medicina familiar de cinco delegaciones del Instituto Mexicano del Seguro Social (IMSS). Métodos: Conforme los códigos de la Décima Revisión de la Clasificación Internacional de Enfermedades se identificaron las complicaciones (hipoglucemia, pie diabético, enfermedad renal, retinopatía, enfermedad cardiaca isquémica, enfermedad cerebrovascular y falla cardiaca) y comorbilidades (enfermedad hepática, cáncer, anemia) de DT2. Se compararon por delegación, edad, sexo y tiempo de evolución. Resultados: Las complicaciones y comorbilidades fueron más comunes en personas ≥ 62 años. De 297 100 pacientes, 34.9 % presentó cualquier complicación; microvasculares en el norte industrial (32 %), macrovasculares en el este rural (12.3 %) y comorbilidades (5 %) en el sur de la Ciudad de México; estas complicaciones predominaron en los hombres (cualquier complicación 30.2 %). La falla cardiaca y las comorbilidades fueron más comunes en mujeres (5.6 y 4.9 %). Conclusiones: Las complicaciones y comorbilidades de DT2 mostraron diferencias geográficas y de sexo y fueron mayores con la edad y el tiempo de evolución. Urge reforzar estrategias para la prevención de las complicaciones y comorbilidades en los pacientes con DT2.