Patient Work and Treatment Burden in Type 2 Diabetes: A Mixed-Methods Study.

OBJECTIVE: To use quantitative and qualitative methods to characterize the work patients with type 2 diabetes mellitus (T2DM) enact and explore the interactions between illness, treatment, and life. PATIENTS AND METHODS: In this mixed-methods, descriptive study, adult patients with T2DM seen at the outpatient diabetes clinic at Mayo Clinic in Rochester, Minnesota, from February 1, 2016, through March 31, 2017, were invited to participate. The study had 3 phases. In phase 1, the Patient Experience with Treatment and Self-management (PETS) scale was used to quantify treatment burden. In phase 2, a convenience sample of patients used a smartphone application to describe, in real time, time spent completing diabetes self-management tasks and to upload descriptive digital photographs. In phase 3, these data were explored in qualitative interviews that were analyed by 2 investigators using deductive analysis. RESULTS: Of 162 participants recruited, 160 returned the survey (phase 1); of the 50 participants who used the smartphone application (phase 2), we interviewed 17 (phase 3). The areas in which patients reported highest treatment burden were difficulty with negotiating health services (eg, coordinating medical appointments), medical expenses, and mental/physical exhaustion with self-care. Participants reported that medical appointments required about 2.5 hours per day, and completing administrative tasks related to health care required about 45 minutes. Time spent on health behaviors varied widely-from 2 to 60 minutes in a given 3-hour period. Patients' experience of a task's burden did not always correlate with the time spent on that task. CONCLUSION: The most burdensome tasks to patients with T2DM included negotiating health care services, affording medications, and completing administrative tasks even though they were not the most time-consuming activities. To be minimally disruptive, diabetes care should minimize the delegation of administrative tasks to patients.

Vólvulo gástrico en una paciente nonagenaria: intervención endoscópica y laparoscópica. Reporte de caso / Gastric volvulus in a nonagenarian patient: endoscopic and laparoscopic intervention. Case report

Resumen El vólvulo gástrico es una entidad rara que puede presentarse de manera aguda o crónica y se acompaña de síntomas inespecíficos. Es fundamental su rápida identificación, ya que tiene alta mortalidad y el tratamiento oportuno de esta patología determina el pronóstico del paciente. A continuación, presentamos el caso de una paciente femenina de 89 años, que consulta por cuadro clínico de dolor torácico atípico, con documentación en radiografía de tórax de vólvulo gástrico organoaxial, en quien se realiza inicialmente devolvulación endoscópica con éxito. Sin embargo, en las imágenes de control se evidencia recurrencia del vólvulo, por lo cual se realizó manejo quirúrgico con hiatoplastia y funduplicatura tipo Toupet, además de gastrostomía percutánea de fijación, procedimiento realizado sin complicaciones, con los que se logró la devolvulación completa sin recurrencia.

Abstract Gastric volvulus is a rare condition that can occur acutely or chronically and is accompanied by nonspecific symptoms. Its rapid identification is critical since it has high mortality rate and timely treatment determines the patient's prognosis. The following is the case of an 89-year-old female patient who presented with atypical chest pain, with organoaxial gastric volvulus on chest X-ray, in whom endoscopic devolvulation was initially performed successfully. However, control imaging scans revealed recurrence. Therefore, surgical management included hiatoplasty and Toupet fundoplication, as well as percutaneous fixation gastrostomy, a procedure that was completed without complications and resulted in complete devolvulation without recurrence.

Rumiación cognitiva y afecto negativo como predictores diferenciales de los síntomas psicopatológicos internalizantes / Cognitive rumination and negative affect as differential predictors of internalizing psychopathological symptoms

Resumen Los modelos transdiagnósticos para los problemas de ansiedad, depresión y somatización han tenido evidencia para variables como la rumiación cognitiva y el afecto negativo; sin embargo, las asociaciones diferenciales entre estas dos variables en la explicación psicopatológica requiere aún ser investigada. El objetivo fue analizar la relación entre la rumiación cognitiva según las dimensiones de la rumiación: reproche y reflexión, con el afecto negativo y los síntomas psicopatológicos internalizantes depresivos, ansiosos y psicosomáticos en adultos colombianos. Se llevó a cabo una investigación cuantitativa con un diseño transversal explicativo, en el que se definió una red estructural de relaciones entre constructos mediante un diagrama de senderos y ecuaciones estructurales. Se contó con una muestra final de 640 personas, con una edad media de 31.07 años (DE = 11.27). Los resultados indicaron correlaciones significativas parciales y de orden cero entre las variables transdiagnósticas y las sintomáticas internalizantes, mediante un modelo ajustado que permitió explicar en un 74 % estas problemáticas a partir de la rumiación cognitiva y la función mediadora parcial del afecto negativo. En los síntomas depresivos y ansiosos se obtuvo que están mediados parcialmente por el afecto negativo, mientras que la medida de somatización obtuvo un coeficiente de regresión significativo con el afecto negativo como predictor independiente. Estos resultados aportan a la comprensión de la interacción de la rumiación y el afecto en la aparición de los síntomas internalizantes de manera diferencial. Se recomendó contar con una muestra clínica que ayudaría a identificar con mayor precisión la varianza explicada del modelo obtenido, lo que favorecerá los actuales tratamientos transdiagnósticos disponibles.

Abstract The transdiagnostic models of anxiety, depression and somatization problems have had evidence for variables such as cognitive rumination and negative affect, however, the differential associations between these two variables in the psychopathological explanation, still need to be investigated. The aim was to analyze the relationship between cognitive rumination according to the two dimensions: brooding and reflection, with negative affect and depressive, anxious, and psychosomatic internalizing psychopathological symptoms. A quantitative research was carried out with an explanatory cross-sectional design in which a structural network of relationships between constructs was defined by a path diagram and structural equations. There was a final sample of 640 people with a mean age of 31.07 years (SD = 11.27). The results indicated significant partial and zero-order correlations between transdiagnostic and internalizing symptomatic variables, using an adjusted model that allowed explaining these problems in 74% from cognitive rumination, and the partial mediating function of negative affect. In depressive and anxious symptoms, they were partially mediated by the negative affect, while the somatization measure obtained a significant regression coefficient with the negative affect as an independent predictor. These results contribute to the understanding of the interaction of rumination and affect in the appearance of differential internalizing symptoms. It was recommended to have a clinical sample that would help to more accurately identify the explained variance of the obtained model, as well as favor the current and available transdiagnostic treatments.

Identification and functional analysis of missense mutations in the lecithin cholesterol acyltransferase gene in a Chilean patient with hypoalphalipoproteinemia.

BACKGROUND: Lecithin-cholesterol acyltransferase (LCAT) is a plasma enzyme that esterifies cholesterol in high- and low-density lipoproteins (HDL and LDL). Mutations in LCAT gene causes familial LCAT deficiency, which is characterized by very low plasma HDL-cholesterol levels (Hypoalphalipoproteinemia), corneal opacity and anemia, among other lipid-related traits. Our aim is to evaluate clinical/biochemical features of a Chilean family with a proband showing clinical signs of familial LCAT deficiency, as well as to identify and assess the functional effects of LCAT mutations. METHODS: An adult female proband with hypoalphalipoproteinemia, corneal opacity and mild anemia, as well as her first-degree relatives, were recruited for clinical, biochemical, genetic, in-silico and in-vitro LCAT analysis. Sequencing of exons and intron-exon boundaries was performed to identify mutations. Site-directed mutagenesis was carried out to generate plasmids containing cDNA with wild type or mutant sequences. Such expression vectors were transfected to HEK-239 T cells to asses the effect of LCAT variants in expression, synthesis, secretion and enzyme activity. In-silico prediction analysis and molecular modeling was also used to evaluate the effect of LCAT variants. RESULTS: LCAT sequencing identified rare p.V333 M and p.M404 V missense mutations in compound heterozygous state in the proband, as well the common synonymous p.L363 L variant. LCAT protein was detected in proband's plasma, but with undetectable enzyme activity compared to control relatives. HEK-293 T transfected cells with vector expression plasmids containing either p.M404 V or p.V333 M cDNA showed detectable LCAT protein expression both in supernatants and lysates from cultured cells, but with much lower enzyme activity compared to cells transfected with the wild-type sequence. Bioinformatic analyses also supported a causal role of such rare variations in LCAT lack of function. Additionally, the proband carried the minor allele of the synonymous p.L363 L variant. However, this variant is unlikely to affect the clinical phenotype of the proband given its relatively high frequency in the Chilean population (4%) and its small putative effect on plasma HDL-cholesterol levels. CONCLUSION: Genetic, biochemical, in vitro and in silico analyses indicate that the rare mutations p.M404 V and p.V333 M in LCAT gene lead to suppression of LCAT enzyme activity and cause clinical features of familial LCAT deficiency.

Lipid-Lowering Agents in Older Individuals: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

BACKGROUND: The efficacy of lipid-lowering agents on patient-important outcomes in older individuals is unclear. METHODS: We included randomized trials that enrolled individuals aged 65 years or older and that included at least 1 year of follow-up.Pairs of reviewers selected and appraised the trials. RESULTS: We included 23 trials that enrolled 60,194 elderly patients. For primary prevention, statins reduced the risk of coronary artery disease [CAD; relative risk (RR): 0.79, 95% CI: 0.68 to 0.91] and myocardial infarction (MI; RR: 0.45, 95% CI: 0.31 to 0.66) but not all-cause or cardiovascular mortality or stroke. These effects were imprecise in patients with diabetes, but there was no significant interaction between diabetes status and the intervention effect. For secondary prevention, statins reduced all-cause mortality (RR: 0.80, 95% CI: 0.73 to 0.89), cardiovascular mortality (RR: 0.68, 95% CI: 0.58 to 0.79), CAD (RR: 0.68, 95% CI: 0.61 to 0.77), MI (RR: 0.68, 95% CI: 0.59 to 0.79), and revascularization (RR: 0.68, 95% CI: 0.61 to 0.77). Intensive (vs less-intensive) statin therapy reduced the risk of CAD and heart failure. Niacin did not reduce the risk of revascularization, and fibrates did not reduce the risk of stroke, cardiovascular mortality, or CAD. CONCLUSION: High-certainty evidence supports statin use for secondary prevention in older individuals. Evidence for primary prevention is less certain. Data in older individuals with diabetes are limited; however, no empirical evidence has shown a significant difference based on diabetes status.

Antihypertensive Agents in Older Adults: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

BACKGROUND: This systematic review summarizes the benefits of treating blood pressure (BP) in individuals 65 years and older. METHODS: We included randomized trials that evaluated BP-lowering medications or BP targets in individuals 65 years and older. Trials were selected and appraised by pairs of independent reviewers. RESULTS: We included 19 trials (42,134 patients). In individuals 65 years or older, antihypertensive therapy was associated with a reduction in all-cause mortality [relative risk: 0.88 (95% CI: 0.81 to 0.94); high certainty evidence; mean follow-up 31 months], cardiovascular mortality, myocardial infarction, heart failure, stroke, and chronic kidney disease. Individuals 75 years or older had a significant reduction in the risk of all-cause and cardiovascular mortality, stroke, and heart failure. Strict systolic BP targets (<120 mm Hg and <130 mm Hg) were associated with a significant reduction in the risk of all-cause and cardiovascular mortality and heart failure, whereas more liberal systolic targets (<150 mm Hg and <160 mm Hg) were associated with lower risk of heart failure and stroke. Older adults with type 2 diabetes mellitus (DM) had lower risk of chronic kidney disease without a significant reduction in other outcomes. However, there was no significant difference in estimates (i.e., interaction) between those with and without DM. CONCLUSIONS: Individuals aged 65 years and older or 75 years and older who receive antihypertensive therapy have statistically significant reduction in the risk of all-cause and cardiovascular mortality, heart failure, and stroke. There was no statistically significant difference in estimates between those with and without DM.

Experiencia con los stents metálicos autoexpandibles para el manejo de cáncer gástrico distal / Auto-expandable metal stent in the management of distal stomach cancer

Objetivos: Establecer la eficacia y seguridad de los stents metálicos antroduodenales para el tratamiento del síndrome pilórico en pacientes con cáncer gástrico distal. Materiales y métodos: Se obtuvo datos de 31 pacientes mayores de 18 años que tenían diagnóstico de cáncer gástrico distal entre el año 2009 y el año 2017, quienes presentaban síndrome pilórico asociado a estenosis antroduodenal documentada por endoscopia o radiografía de vías digestivas altas, siendo manejados con stent metálico autoexpandible antroduodenal en la unidad de gastroenterología del Hospital Universitario San Ignacio (HUSI) de Bogotá D.C, Colombia. Resultados: El principal síntoma documentado que motivó a consultar fue la presencia de vómito en el 45,1%, seguido por pérdida de peso 16,13% y hemorragia de vías digestivas altas 19,35%, realizándose el diagnóstico en el 74,19% de los casos con endoscopia de vías digestivas altas. El 96,7% de los pacientes presentaban metástasis al momento del diagnóstico de síndrome pilórico. El 100% de los pacientes tuvo éxito técnico en relación al implante del stent con posterior resolución de síntomas en el 96,77%, siendo la complicación más frecuente el desplazamiento en un 16,13%. Conclusiones: Los stents metálicos autoexpandibles para el manejo de la obstrucción al tracto de salida gástrico secundario a cáncer gástrico distal es un método seguro y eficaz como tratamiento paliativo, mejorando la morbilidad y mortalidad en comparación con el manejo quirúrgico.

Objectives: To establish the efficacy and safety of antroduodenal metal stents for the treatment of pyloric syndrome in patients with distal gastric cancer. Materials and methods: Data were obtained from 31 patients older than 18 years who had a diagnosis of distal gastric cancer between 2009 and 2017, who presented pyloric syndrome associated with antroduodenal stenosis documented by endoscopy or X-ray of upper digestive tract, being managed with an antroduodenal auto-expandable metal stent in the gastroenterology unit of the San Ignacio University Hospital (HUSI) in Bogotá DC, Colombia. Results: The main documented symptom that led to consultation was the presence of vomiting in 45.1%, followed by weight loss 16.13% and upper digestive tract bleeding 19.35%, the diagnosis being made in 74.19 % of cases with endoscopy of upper digestive tract. 96.7% of the patients presented metastases at the time of diagnosis of pyloric syndrome. 100% of patients had technical success in relation to stenting with subsequent resolution of symptoms in 96.77%, the most frequent complication being displacement in 16.13%. Conclusions: Auto-expandable metal stents for the management of gastric outlet tract obstruction secondary to distal gastric cancer is a safe and effective method as a palliative treatment, improving morbidity and mortality compared to surgical management.

The efficacy and adverse events of testosterone replacement therapy in hypogonadal men: A systematic review and meta-analysis of randomized, placebo-controlled trials.

CONTEXT: The efficacy and safety of testosterone replacement therapy (TRT) in hypogonadal men remain incompletely understood. OBJECTIVE: To conduct a systematic review and meta-analysis of randomized clinical trials (RCT) to determine the effects of TRT on patient-important outcomes and adverse events in hypogonadal men. DATA SOURCES: We searched Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Database of Systematic Reviews, Ovid Cochrane Central Register of Controlled Trials, and Scopus from inception to March 2th, 2017. STUDY SELECTION: RCTs that assessed the efficacy and adverse events of TRT of at least 12 weeks compared with placebo in adult men with hypogonadism, defined by morning testosterone ≤300 ng/dL and at least one symptom or sign of hypogonadism. DATA EXTRACTION: Reviewers working independently and in duplicate assessed the quality of the trials and collected data on patient characteristics, interventions, and outcomes. DATA SYNTHESIS: We found 11 publications, reporting on 4 eligible trials (including 1,779 patients) at low risk of bias. Compared to placebo, TRT was associated with a small but significant increase in sexual desire or libido [standardized mean difference (SMD): 0.17, 95% CI 0.01, 0.34] (n=1383), erectile function [SMD: 0.16, 95% CI 0.06, 0.27] (n=1344), and sexual satisfaction [SMD: 0.16, 95% CI 0.01, 0.31] (n=676), but had no effect on energy or mood. TRT was associated with an increased risk of developing erythrocytosis [relative risk: 8.14, 95% CI: 1.87, 35.40] (n=1579) compared to placebo, but had no significant effect on lower urinary tract symptoms (LUTS). CONCLUSION: In hypogonadal men TRT improves sexual desire, erectile function, and sexual satisfaction, however it increases the risk of erythrocytosis.

Correction to: Estrogen-based hormone therapy in women with primary ovarian insufficiency: a systematic review.

In the original publication, the given and family name of the author Mohammad Hassan Murad was incorrect. This has been corrected with this erratum.

Does Health Coaching Grow Capacity in Cancer Survivors? A Systematic Review.

Interventions that grow patient capacity to do the work of health care and life are needed to support the health of cancer survivors. Health coaching may grow capacity. This systematic review of health coaching interventions explored coaching's ability to grow capacity of cancer survivors. The authors included randomized trials or quasi-experimental studies comparing coaching to alternative interventions, and adhered to PRISMA reporting guidelines. Data were analyzed using the Theory of Patient Capacity (BREWS: Capacity is affected by factors that influence ability to reframe Biography ["B"], mobilize or recruit Resources ["R"], interact with the Environment of care ["E"], accomplish Work ["W"]), and function Socially ["S"]). The authors reviewed 2210 references and selected 12 studies (6 randomized trials and 6 pre-post). These studies included 1038 cancer survivors, mean age 57.2 years, with various type of cancers: breast, colorectal, prostate, and lung. Health coaching was associated with improved quality of life, mood, and physical activity but not self-efficacy. Classified by potential to support growth in patient capacity, 67% of included studies reported statistically significant outcomes that support "B" (quality of life, acceptance, spirituality), 75% "R" (decreased fatigue, pain), 67% "W" (increased physical activity), and 33% "S" (social deprivation index). None addressed changing the patient's environment of care. In cancer survivors, health coaching improved quality of life and supported patient capacity by several mechanisms, suggesting an important role for "Capacity Coaching." Future interventions that improve self-efficacy and patients' environments of care are needed. Capacity Coaching may improve health and quality of life of cancer survivors.

Trends in P Value, Confidence Interval, and Power Analysis Reporting in Health Professions Education Research Reports: A Systematic Appraisal.

PURPOSE: To characterize reporting of P values, confidence intervals (CIs), and statistical power in health professions education research (HPER) through manual and computerized analysis of published research reports. METHOD: The authors searched PubMed, Embase, and CINAHL in May 2016, for comparative research studies. For manual analysis of abstracts and main texts, they randomly sampled 250 HPER reports published in 1985, 1995, 2005, and 2015, and 100 biomedical research reports published in 1985 and 2015. Automated computerized analysis of abstracts included all HPER reports published 1970-2015. RESULTS: In the 2015 HPER sample, P values were reported in 69/100 abstracts and 94 main texts. CIs were reported in 6 abstracts and 22 main texts. Most P values (≥77%) were ≤.05. Across all years, 60/164 two-group HPER studies had ≥80% power to detect a between-group difference of 0.5 standard deviations. From 1985 to 2015, the proportion of HPER abstracts reporting a CI did not change significantly (odds ratio [OR] 2.87; 95% CI 1.04, 7.88) whereas that of main texts reporting a CI increased (OR 1.96; 95% CI 1.39, 2.78). Comparison with biomedical studies revealed similar reporting of P values, but more frequent use of CIs in biomedicine. Automated analysis of 56,440 HPER abstracts found 14,867 (26.3%) reporting a P value, 3,024 (5.4%) reporting a CI, and increased reporting of P values and CIs from 1970 to 2015. CONCLUSIONS: P values are ubiquitous in HPER, CIs are rarely reported, and most studies are underpowered. Most reported P values would be considered statistically significant.

[Auto-expandable metal stent in the management of distal stomach cancer]. / Experiencia con los stents metálicos autoexpandibles para el manejo de cáncer gástrico distal.

OBJECTIVES: To establish the efficacy and safety of antroduodenal metal stents for the treatment of pyloric syndrome in patients with distal gastric cancer. MATERIALS AND METHODS: Data were obtained from 31 patients older than 18 years who had a diagnosis of distal gastric cancer between 2009 and 2017, who presented pyloric syndrome associated with antroduodenal stenosis documented by endoscopy or X-ray of upper digestive tract, being managed with an antroduodenal auto-expandable metal stent in the gastroenterology unit of the San Ignacio University Hospital (HUSI) in Bogotá DC, Colombia. RESULTS: The main documented symptom that led to consultation was the presence of vomiting in 45.1%, followed by weight loss 16.13% and upper digestive tract bleeding 19.35%, the diagnosis being made in 74.19 % of cases with endoscopy of upper digestive tract. 96.7% of the patients presented metastases at the time of diagnosis of pyloric syndrome. 100% of patients had technical success in relation to stenting with subsequent resolution of symptoms in 96.77%, the most frequent complication being displacement in 16.13%. CONCLUSIONS: Auto-expandable metal stents for the management of gastric outlet tract obstruction secondary to distal gastric cancer is a safe and effective method as a palliative treatment, improving morbidity and mortality compared to surgical management.

Estrogen-based hormone therapy in women with primary ovarian insufficiency: a systematic review.

PURPOSE: Sex hormones play a role in bone density, cardiovascular health, and wellbeing throughout reproductive lifespan. Women with primary ovarian insufficiency (POI) have lower estrogen levels requiring hormone therapy (HT) to manage symptoms and to protect against adverse long-term health outcomes. Yet, the effectiveness of HT in preventing adverse outcomes has not been systematically assessed. We summarize the evidence regarding effects of HT on bone and cardiovascular health in women with POI. METHODS: A comprehensive search of the electronic databases MEDLINE, EMBASE, and Scopus was conducted by a medical reference librarian from database inception to January 2016. Randomized trials and observational cohort studies with an estrogen-based HT intervention in women with POI under the age of 40 were included. Reviewers worked independently and in duplicate to assess eligibility and risk of bias, and extract data of interest from each study. RESULTS: The search identified 1670 articles; 12 met inclusion criteria. Four randomized clinical trials and eight cohort studies at high risk of bias enrolled 806 women with POI. The most common HT formulations were transdermal estradiol and oral conjugated equine estrogen combined with medroxyprogesterone acetate. Bone mineral density was the most frequent outcome, with three out of eight studies showing HT associated increase benefits. Only one study reported effects on fractures or vasomotor symptoms and none on cardiovascular mortality. Results regarding lipid profiles were inconsistent. CONCLUSIONS: Evidence supporting bone and cardiovascular benefits of HT in women with POI is limited by high risk of bias, reliance on surrogate outcomes, and heterogeneity of trials regarding the formulation, dose, route of administration, and regimen of HT. Further research addressing patient important outcomes such as fractures, stroke, and cardiovascular mortality are crucial to optimize benefits of this therapy.

Minimally Disruptive Medicine for Patients with Diabetes.

PURPOSE OF REVIEW: Patients with diabetes must deal with the burden of symptoms and complications (burden of illness). Simultaneously, diabetes care demands practical and emotional work from patients and their families, work to access and use healthcare and to enact self-care (burden of treatment). Patient work must compete with the demands of family, job, and community life. Overwhelmed patients may not have the capacity to access care or enact self-care and will thus experience suboptimal diabetes outcomes. RECENT FINDINGS: Minimally disruptive medicine (MDM) is a patient-centered approach to healthcare that prioritizes patients' goals for life and health while minimizing the healthcare disruption on patients' lives. In patients with diabetes, particularly in those with complex lives and multimorbidity, MDM coordinates healthcare and community responses to improve outcomes, reduce treatment burden, and enable patients to pursue their life's hopes and dreams.

[Shared decision making in patients with diabetes mellitus]. / Toma de decisiones compartidas en la atención de pacientes con diabetes mellitus: un desafío para Latinoamérica.

Patients with diabetes mellitus often have several medical problems and carry a burden imposed by their illness and treatment. Health care often ignores the values, preferences and context of patients, leading to treatments that do not fit into patients’ overwhelmed lives. Shared Decision Making (SDM) emerges as a way to answer the question: “What’s best for the patient?”. SDM promotes an empathic conversation between patients and clinicians that integrates the best evidence available with their values, preferences and context. We discuss three SDM approaches for patients with diabetes: one focused on sharing information, another on making choices, and a third one on helping patients and clinicians to talk about how to address the problems of living with diabetes and its comorbidities. Despite the benefits demonstrated in studies conducted in the U.S. and Europe, the implementation of SDM continues to be a challenge. In Latin America, healthcare and socio-economic conditions render the implementation of SDM more challenging. Research aimed to respond to this challenge is necessary. Meanwhile, clinicians can practice SDM by sharing evidence-based information, giving voice to patients’ values and preferences in making choices, and creating empathic conversations aimed at decisions aligned with patients’ context, dreams, goals, and life expectations.

Toma de decisiones compartidas en la atención de pacientes con diabetes mellitus: un desafío para Latinoamérica / Shared decision making in patients with diabetes mellitus

Patients with diabetes mellitus often have several medical problems and carry a burden imposed by their illness and treatment. Health care often ignores the values, preferences and context of patients, leading to treatments that do not fit into patients’ overwhelmed lives. Shared Decision Making (SDM) emerges as a way to answer the question: “What’s best for the patient?”. SDM promotes an empathic conversation between patients and clinicians that integrates the best evidence available with their values, preferences and context. We discuss three SDM approaches for patients with diabetes: one focused on sharing information, another on making choices, and a third one on helping patients and clinicians to talk about how to address the problems of living with diabetes and its comorbidities. Despite the benefits demonstrated in studies conducted in the U.S. and Europe, the implementation of SDM continues to be a challenge. In Latin America, healthcare and socio-economic conditions render the implementation of SDM more challenging. Research aimed to respond to this challenge is necessary. Meanwhile, clinicians can practice SDM by sharing evidence-based information, giving voice to patients’ values and preferences in making choices, and creating empathic conversations aimed at decisions aligned with patients’ context, dreams, goals, and life expectations.

Effect of estrogen replacement therapy on bone and cardiovascular outcomes in women with turner syndrome: a systematic review and meta-analysis.

Patients with Turner syndrome have adverse bone and cardiovascular outcomes from chronic estrogen deficiency. Hence, long-term estrogen replacement therapy is the cornerstone treatment. The estimates of its effect and optimal use, however, remain uncertain. We aimed to summarize the benefits and harms of estrogen replacement therapy on bone, cardiovascular, vasomotor and quality of life outcomes in patients with Turner syndrome. A comprehensive search of four databases was performed from inception through January 2016. Randomized clinical trials and observational cohort studies studying the effect of estrogen replacement therapy in patients with Turner syndrome under the age of 40 were included. Independently and in duplicate reviewers selected studies, extracted data and assessed risk of bias. Subgroup analyses were based on route of administration and type of estrogen formulation. Twenty-five studies at moderate to high risk of bias (12 randomized trials, 13 cohort studies) with 771 patients were included. Using random-effects models, estrogen replacement therapy showed an increase in bone mineral density [weighted mean change from baseline 0.09 g/cm2 (0.04-0.14)] that differed by type of estrogen but not route of administration. Oral estrogen replacement therapy showed a higher increase in high density lipoprotein cholesterol levels when compared to transdermal [weighted mean difference 9.33 mg/dl (4.82-13.85)] with no significant effect on other lipid fractions. The current evidence suggests possible benefit of estrogen replacement therapy on bone mineral density and high density lipoprotein cholesterol. Whether this improvement translates into changes in patient important outcomes (cardiovascular events or fractures) remains uncertain. Larger randomized clinical trials with direct comparisons on patient important outcomes are necessary.

Oxytocin for preventing postpartum haemorrhage (PPH) in non-facility birth settings.

BACKGROUND: Postpartum haemorrhage (PPH) is the single leading cause of maternal mortality worldwide. Most of the deaths associated with PPH occur in resource-poor settings where effective methods of prevention and treatment - such as oxytocin - are not accessible because many births still occur at home, or in community settings, far from a health facility. Likewise, most of the evidence supporting oxytocin effectiveness comes from hospital settings in high-income countries, mainly because of the need of well-organised care for its administration and monitoring. Easier methods for oxytocin administration have been developed for use in resource-poor settings, but as far as we know, its effectiveness has not been assessed in a systematic review. OBJECTIVES: To assess the effectiveness and safety of oxytocin provided in non-facility birth settings by any way in the third stage of labour to prevent PPH. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, the WHO International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov (12 November 2015), and reference lists of retrieved reports. SELECTION CRITERIA: All published, unpublished or ongoing randomised or quasi-randomised controlled trials comparing the administration of oxytocin with no intervention, or usual/standard care for the management of the third stage of labour in non-facility birth settings were considered for inclusion.Quasi-randomised controlled trials and randomised controlled trials published in abstract form only were eligible for inclusion but none were identified. Cross-over trials were not eligible for inclusion in this review. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for eligibility, assessed risk of bias and extracted the data using an agreed data extraction form. Data were checked for accuracy. MAIN RESULTS: We included one cluster-randomised trial conducted in four rural districts in Ghana that randomised 28 community health officers (CHOs) (serving 2404 potentially eligible pregnant women) to the intervention group and 26 CHOs (serving 3515 potentially eligible pregnant women) to the control group. Overall, the trial had a high risk of bias. CHOs delivered the intervention in the experimental group (injection of 10 IU (international units) of oxytocin in the thigh one minute following birth using a prefilled, auto-disposable syringe). In the control group, CHOs did not provide this prophylactic injection to the women they observed. CHOs had no midwifery skills and did not in any way manage the birth. All other CHO activities (outcome measurement, data collection, and early treatment and referral when necessary) were identical across the control and oxytocin CHOs.Although only one of the nine cases of severe PPH (blood loss greater or equal to 1000 mL) occurred in the oxytocin group, the effect estimate for this outcome was very imprecise and it is uncertain whether the intervention prevents severe PPH (risk ratio (RR) 0.16, 95% confidence interval (CI) 0.02 to 1.30; 1570 women (very low-quality evidence)). Similarly, because of the lack of cases of severe maternal morbidity (e.g. uterine rupture) and maternal deaths, it was not possible to obtain effect estimates for those outcomes (both very low-quality evidence).Oxytocin compared with the control group decreased the incidence of PPH (> 500 mL) in both our unadjusted (RR 0.48, 95% CI 0.28 to 0.81; 1569 women) and adjusted (RR 0.49, 95% CI 0.27 to 0.90; 1174 women (both low-quality evidence)) analyses. There was little or no difference between the oxytocin and control groups on the rates of transfer or referral of the mother to a healthcare facility (RR 0.72, 95% CI 0.34 to 1.56; 1586 women (low-quality evidence)), stillbirths (RR 1.27, 95% CI 0.67 to 2.40; 2006 infants (low-quality evidence)); andearly infant deaths (0 to three days) (RR 1.03, 95% CI 0.35 to 3.07; 1969 infants (low-quality evidence)). There were no cases of needle-stick injury or any other maternal major or minor adverse event or unanticipated harmful event. There were no cases of oxytocin use during labour.There were no data reported for some of this review's secondary outcomes: manual removal of placenta, maternal anaemia, neonatal death within 28 days, neonatal transfer to health facility for advanced care, breastfeeding rates. Similarly, the women's or the provider's satisfaction with the intervention was not reported. AUTHORS' CONCLUSIONS: It is uncertain if oxytocin administered by CHO in non-facility settings compared with a control group reduces the incidence of severe PPH (>1000 mL), severe maternal morbidity or maternal deaths. However, the intervention probably decreases the incidence of PPH (> 500 mL).The quality of the one trial included in this review was limited because of the risk of attrition and recruitment biases related to limitations in the follow-up of pregnant women in both arms of the trials and some baseline imbalance on the size of babies at birth. Additionally, there was serious imprecision of the effect estimates for most of the primary outcomes mainly because of the size of the trial, very few or no events and CIs around both relative and absolute estimates of effect that include both appreciable benefit and appreciable harm.Although the trial presented data both for primary and secondary outcomes, it seemed to be underpowered to detect differences in the primary outcomes that are the ones more relevant for making judgments about the potential applicability of the intervention in other settings (especially severe PPH).Therefore, taking into account the extreme setting where the intervention was implemented, the limited role of the CHO in the trial and the lack of power for detecting effects on primary (relevant) outcomes, the applicability of the evidence found seems to be rather limited.Further well-executed and adequately-powered randomised controlled trials assessing the effects of using oxytocin in pre-filled injection devices or other new delivery systems (spray-dried ultrafine formulation of oxytocin) on severe PPH are urgently needed. Likewise, other important outcomes like possible adverse events and acceptability of the intervention by mothers and other community stakeholders should also be assessed.

[Nicotinic acid increases cellular transport of high density lipoprotein cholesterol in patients with hypoalphalipoproteinemia]. / El ácido nicotínico aumenta el transporte celular de colesterol de las lipoproteínas de alta densidad en pacientes con hipoalfalipoproteinemia.

BACKGROUND: Plasma high density lipoproteins (HDL) are involved in reverse cholesterol transport mediated by the scavenger receptor class B type I (SR-BI). Nicotinic acid increases HDL cholesterol levels, even though its specific impact on SR-BI dependent-cellular cholesterol transport remains unknown. AIM: To determine the effect of nicotinic acid on HDL particle functionality in cholesterol efflux and uptake mediated by SR-BI in cultured cells in hypoalphalipoproteinemic patients. MATERIAL AND METHODS: In a pilot study, eight patients with low HDL (≤ 40 mg/dL) were treated with extended release nicotinic acid. HDL cholesterol and phospholipid levels, HDL2 and HDL3 fractions and HDL particle sizes were measured at baseline and post-therapy. Before and after nicotinic acid treatment, HDL particles were used for cholesterol transport studies in cells transfected with SR-BI. RESULTS: Nicotinic acid treatment raised total HDL cholesterol and phospholipids, HDL2 levels as well as HDL particle size. Nicotinic acid significantly increased HDL cholesterol efflux and uptake capacity mediated by SR-BI in cultured cells. CONCLUSIONS: Nicotinic acid therapy increases SR-BI-dependent HDL cholesterol transport in cultured cells, establishing a new cellular mechanism by which this lipid-lowering drug appears to modulate HDL metabolism in patients with hypoalphalipoproteinemia.

Disfuncionalidad antioxidante de las lipoproteínas de alta densidad (HDL) en pacientes diabéticos descompensados / Antioxidant dysfunctionality of high-density lipoproteins (hdl) in decompensated diabetic patients

Introducción: las lipoproteínas de alta densidad (HDL) tienen un importante efecto protector cardiovascular mediado por su función durante el transporte reverso del colesterol, así como por otras actividades, incluyendo una significativa acción antiinflamatoria y antioxidante. La funcionalidad antiinflamatoria y antioxidante de las HDL está alterada en los pacientes diabéticos crónicos estables, aunque no existe mayor información en caso de una crisis hiperglicémica. Objetivo: determinar si durante un estado de descompensación diabética aguda las partículas de HDL exhiben un deterioro de su función antioxidante y si esta logra recuperarse una vez resuelto el cuadro agudo. Métodos: la actividad antioxidante de las HDL se midió mediante un ensayo de fluorescencia in vitro en muestras plasmáticas de pacientes diabéticos con descompensación aguda obtenidas tanto al ingreso, alcanzada la resolución intrahospitalaria del evento agudo, así como en un control ambulatorio post-hospitalización. Como comparación, se analizaron partículas de HDL de algunos sujetos sanos como condición control. Resultados: la actividad antioxidante de las HDL en pacientes con descompensación diabética aguda fue significativamente menor a la observada en el grupo control sano, y esta se fue recuperando progresivamente hasta normalizarse en el momento del control ambulatorio. La crisis hiperglicémica también demostró una baja actividad plasmática de la enzima antioxidante paraoxonasa-1, la cual aumentó significativamente en el control ambulatorio. Conclusión: las partículas de HDL presentes en pacientes con una descompensación diabética aguda presentan reducción significativa y reversible de su capacidad antioxidante, probablemente como consecuencia de una alteración en la actividad de la paraoxonasa-1 (AU)

Introduction: high density lipoproteins (HDL) have important cardiovascular protective effects mediated by their role in reverse cholesterol transport as well as other functional activities, including significant anti-inflammatory and antioxidant properties. It has been shown that HDL anti-inflammatory and antioxidant functions are defective in metabolically stable diabetic patients; however they have not been evaluated during a hyperglycemic crisis. Aim: to determine the antioxidant activity of HDL during a severe diabetic decompensation and to analyze whether this function is restored after resolution of the acute event. Methods: the antioxidant activity of HDL was measured in vitro by a fluorescent assay in plasma samples obtained from diabetic patients with acute metabolic decompensation at admission, recovery within the hospital and follow-up in ambulatory care. As a comparison, HDL particles from some healthy subjects were used as controls. Results: the HDL antioxidant function was significantly reduced in patients during an acute diabetic decompensation compared with the control group, and was gradually restored reaching normal values during the ambulatory follow-up. Hyperglycemic crisis also showed low plasma paraoxonase-1 activity, which increased significantly during at follow-up. Conclusion: HDL particles isolated from acute diabetic descompensated patients exhibit a significantly and reversibly low antioxidant capacity, which is probably due to a reduced paraoxonase-1 activity (AU)