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2.
Thyroid ; 2020 Jan 23.
Artigo em Inglês | MEDLINE | ID: mdl-31973681

RESUMO

Background Considerable uncertainty remains about the pattern of use of treatment options for Graves' disease (GD) and their comparative effectiveness and safety. Methods Between 2005 and 2013, we identified patients with GD that received antithyroid drugs (ATD), radioactive iodine (RAI) or surgery; and were represented in a large administrative dataset in the United States (OptumLabs Data Warehouse). Results We identified 4661 patients with GD: mean age 48 (SD 14) years, white (63%) and female (80%). Patients received ATD, n=2817 (60%), RAI, n=1549 (33%) or surgery, n=295 (6%). Success rates were 50% for ATD, 93% for RAI, and 99% for surgery. Median time to treatment failure was 6.8 months for ATD and 3 months for RAI and surgery. When patients were required to be on ATD for at least one year before assessing failure, the failure rate decreased to 25%. Adverse effects occurred in 12% of patients receiving ATD, 6% with RAI and 24% with surgery. Factors associated with treatment success were age > 55 years (for ATD) and female gender (for RAI). About 12% of patients receiving ATD continued this treatment for > 24 months as initial therapy. When patients failed ATD therapy, the most common second line therapy was re-initiation of ATD (65%), RAI (26%) and surgery (9%). Overall, 26% of patients remain on ATD therapy (combined first or second line). Conclusions ATD therapy was the most common GD therapy and demonstrated the lowest efficacy and infrequent significant adverse effect profile. With one fourth of patients remaining on ATD treatment (initial or second modality treatment), it becomes imperative to determine the long-term efficacy, safety, costs, and burdens of this modality of treatment.

3.
Endocrine ; 2019 Dec 04.
Artigo em Inglês | MEDLINE | ID: mdl-31802353

RESUMO

PURPOSE: To examine the proportion of diabetes-focused clinical encounters in primary care and endocrinology practices where the evaluation for hypoglycemia is documented; and when it is, identify clinicians' stated actions in response to patient-reported events. METHODS: A total of 470 diabetes-focused encounters among 283 patients nonpregnant adults (≥18 years) with type 1 or type 2 diabetes mellitus in this retrospective cohort study. Participants were randomly identified in blocks of treatment strategy and care location (95 and 52 primary care encounters among hypoglycemia-prone medications (i.e. insulin, sulfonylurea) and others patients, respectively; 94 and 42 endocrinology encounters among hypo-treated and others, respectively). Documentation of hypoglycemia and subsequent management plan in the electronic health record were evaluated. RESULTS: Overall, 132 (46.6%) patients had documentation of hypoglycemia assessment, significantly more prevalent among hypo-treated patients seen in endocrinology than in primary care (72.3% vs. 47.4%; P = 0.001). Hypoglycemia was identified by patient in 38.2% of encounters. Odds of hypoglycemia assessment documentation was highest among the hypo-treated (OR 13.6; 95% CI 5.5-33.74, vs. others) and patients seen in endocrine clinic (OR 4.48; 95% CI 2.3-8.6, vs. primary care). After documentation of hypoglycemia, treatment was modified in 30% primary care and 46% endocrine clinic encounters; P = 0.31. Few patients were referred to diabetes self-management education and support (DSMES). CONCLUSIONS: Continued efforts to improve hypoglycemia evaluation, documentation, and management are needed, particularly in primary care. This includes not only screening at-risk patients for hypoglycemia, but also modifying their treatment regimens and/or leveraging DSMES.

4.
Int J Clin Pract ; : e13453, 2019 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-31769902

RESUMO

BACKGROUND: Insulin resistance (IR) precedes the diagnosis of many metabolic and non-metabolic illnesses, including type 2 diabetes mellitus (T2DM). Acanthosis nigricans (AN) is a clinical sign associated with IR. However, AN prevalence and diagnostic accuracy in middle-age adults before or at the time of prediabetes/diabetes diagnosis remain uncertain. METHODS: With the aim to define AN prevalence and diagnostic accuracy, adults between 40 and 60 years of age were consecutively invited to participate in the study. Participants were categorised into one of two main groups: individuals with normoglycaemia (group 1) and hyperglycaemia (group 2 [ie, prediabetes/diabetes]). Demographic, clinical, anthropometric characteristics, homeostasis model assessment of IR, homeostatic model assessment of ß-cell function, as well as the presence of AN on the neck, axillae, elbows and knuckles were assessed. RESULTS: A total of 320 consecutive participants with a mean age of 49.3 years (59.4% women) were included. Overall, AN prevalence was 46.3%, while AN in group 1 and group 2 was 36.3% and 49.6%, respectively (P = .04). The most common affected sites in group 1 (n = 80) were the knuckles (21.2%) and the neck (17.5%), while in group 2 (n = 240), the neck (29.6%) followed by the knuckles (26.7%). The specificity and positive predictive value of AN for IR were 0.85 and 0.86 in group 1 and 0.90 and 0.96 in group 2, respectively. CONCLUSIONS: In middle-age adults, within the entire spectrum of carbohydrate tolerance, AN is highly prevalent and specific. This finding supports its assessment as a reliable and convenient clinical sign of IR. The understanding of AN behaviour through different carbohydrate tolerance strata, and its different locations, could lead to early detection of individuals at high metabolic risk or help direct a more pathophysiological treatment approach in patients with T2DM.

5.
BMJ ; 367: l5887, 2019 11 05.
Artigo em Inglês | MEDLINE | ID: mdl-31690574

RESUMO

Diabetes is a major and costly health concern worldwide, with high morbidity, disability, mortality, and impaired quality of life. The vast majority of people living with diabetes have type 2 diabetes. Historically, the main strategy to reduce complications of type 2 diabetes has been intensive glycemic control. However, the body of evidence shows no meaningful benefit of intensive (compared with moderate) glycemic control for microvascular and macrovascular outcomes important to patients, with the exception of reduced rates of non-fatal myocardial infarction. Intensive glycemic control does, however, increase the risk of severe hypoglycemia and incurs additional burden by way of polypharmacy, side effects, and cost. Additionally, data from cardiovascular outcomes trials showed that cardiovascular, kidney, and mortality outcomes may be improved with use of specific classes of glucose lowering drugs largely independently of their glycemic effects. Therefore, delivering evidence based, patient centered care to people with type 2 diabetes requires a paradigm shift and departure from the predominantly glucocentric view of diabetes management. Instead of prioritizing intensive glycemic control, the focus needs to be on ensuring access to adequate diabetes care, aligning glycemic targets to patients' goals and situations, minimizing short term and long term complications, reducing the burden of treatment, and improving quality of life.


Assuntos
Complicações do Diabetes/prevenção & controle , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemia/epidemiologia , Hipoglicemiantes/administração & dosagem , Qualidade de Vida , Glicemia/análise , Glicemia/efeitos dos fármacos , Complicações do Diabetes/sangue , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Medicina Baseada em Evidências/métodos , Medicina Baseada em Evidências/normas , Humanos , Hiperglicemia/sangue , Hiperglicemia/tratamento farmacológico , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Incidência , Metanálise como Assunto , Assistência Centrada no Paciente/métodos , Assistência Centrada no Paciente/normas , Guias de Prática Clínica como Assunto , Revisão Sistemática como Assunto , Resultado do Tratamento
6.
Diabetes Ther ; 10(6): 2169-2181, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31599392

RESUMO

INTRODUCTION: Acanthosis nigricans (AN) is an early clinical sign of insulin resistance (IR) primarily in adults. The prevalence and association of AN and IR in infants, however, remains uncertain. We aimed to describe the prevalence of AN and its association with IR in a group of Latin-American infants. METHODS: We studied a random sample of 227 healthy infants between 9 and 24 months of age. After a complete clinical history was obtained and a physical examination was performed, fasting plasma glucose and serum insulin were measured. Three blinded evaluators assessed AN in each patient. Infants with AN were categorized as cases. The HOMA-IR index cutoffs of ≥ 90th and ≥ 95th percentiles were considered IR. RESULTS: There were 49 infants with AN (21.6%) (cases) and 178 without AN (78.4%) (controls). Cases had a significantly higher mean serum insulin, fasting plasma glucose, and HOMA-IR levels of 3.67 ± 2.56 µU/ml vs. 2.42 ± 1.45 µU/ml, P = 0.005; 84.2 ± 12.6 mg/dL vs. 77 ± SD 9.9 mg/dL, P ≤ 0.001; HOMA-IR 0.77 ± 0.54 vs. 0.46 ± 0.28, P ≤ 0.001, respectively. More cases than controls presented HOMA-IR levels ≥ 95th percentile (cases 18.4%; controls 0.5%, P ≤ 0.001) and ≥ 90th percentile (cases 32.7%; controls 1.6%, P ≤ 0.001). AN in the knuckles had a high sensitivity and a negative predictive value (NPV) for detecting patients with HOMA-IR levels above the 95th percentile (sensitivity 90%; NPV 99.4%) and above the 90th percentile (sensitivity 84.2%; NPV 98.3%). CONCLUSION: AN in the knuckles is a prevalent, non-invasive, costless, and reliable screening clinical tool that can be used for early detection of infants with IR and a high metabolic risk.

7.
JAMA Netw Open ; 2(10): e1913249, 2019 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-31603490

RESUMO

Importance: Differences in readmission rates among racial and ethnic minorities have been reported, but data among people with diabetes are lacking despite the high burden of diabetes and its complications in these populations. Objectives: To examine racial/ethnic differences in all-cause readmission among US adults with diabetes and categorize patient- and system-level factors associated with these differences. Design, Setting, and Participants: This retrospective cohort study includes 272 758 adult patients with diabetes, discharged alive from the hospital between January 1, 2009, and December 31, 2014, and stratified by race/ethnicity. An administrative claims data set of commercially insured and Medicare Advantage beneficiaries across the United States was used. Data analysis took place between October 2016 and February 2019. Main Outcomes and Measures: Unplanned all-cause readmission within 30 days of discharge and individual-, clinical-, economic-, index hospitalization-, and hospital-level risk factors for readmission. Results: A total of 467 324 index hospitalizations among 272 758 adults with diabetes (mean [SD] age, 67.7 [12.7]; 143 498 [52.6%] women) were examined. The rates of 30-day all-cause readmission were 10.2% (33 683 of 329 264) among white individuals, 12.2% (11 014 of 89 989) among black individuals, 10.9% (4151 of 38 137) among Hispanic individuals, and 9.9% (980 of 9934) among Asian individuals (P < .001). After adjustment for all factors, only black patients had a higher risk of readmission compared with white patients (odds ratio, 1.05; 95% CI, 1.02-1.08). This increased readmission risk among black patients was sequentially attenuated, but not entirely explained, by other demographic factors, comorbidities, income, reason for index hospitalization, or place of hospitalization. Compared with white patients, both black and Hispanic patients had the highest observed-to-expected (OE) readmission rate ratio when their income was low (annual household income <$40 000 among black patients: OE ratio, 1.11; 95% CI, 1.09-1.14; among Hispanic patients: OE ratio, 1.11; 95% CI, 1.07-1.16) and when they were hospitalized in nonprofit hospitals (black patients: OE ratio, 1.10; 95% CI, 1.08-1.12; among Hispanic patients: OE ratio, 1.08; 95% CI, 1.05-1.12), academic hospitals (black patients: OE ratio, 1.16; 95% CI, 1.13-1.20; Hispanic patients: OE ratio, 1.12; 95% CI, 1.06-1.19), or large hospitals (ie, with ≥400 beds; black patients: OE ratio, 1.11; 95% CI, 1.09-1.14; Hispanic patients: OE ratio, 1.09; 95% CI, 1.04-1.14). Conclusions and Relevance: In this study, black patients with diabetes had a significantly higher risk of readmission than members of other racial/ethnic groups. This increased risk was most pronounced among lower-income patients hospitalized in nonprofit, academic, or large hospitals. These findings reinforce the importance of identifying and addressing the many reasons for persistent racial/ethnic differences in health care quality and outcomes.

8.
J Endocr Soc ; 3(10): 1892-1906, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31598570

RESUMO

Evidence regarding the effects of subclinical hypothyroidism (SCH) on adverse pregnancy outcomes and the ability of levothyroxine (LT4) treatment to prevent them is unclear. Available recommendations for the management of SCH during pregnancy are inconsistent. We conducted a nationwide survey among physicians assessing their knowledge of and current practices in the care of SCH in pregnancy and compared these with the most recent American Thyroid Association (ATA) recommendations. In this cross-sectional study, an online survey was sent to active US members of the Endocrine Society. This survey included questions about current practices and clinical scenarios aimed at assessing diagnostic evaluation, initiation of therapy, and follow-up in pregnant women with SCH. In total, 162 physicians completed the survey. ATA guidelines were reviewed by 76%, of whom 53% indicated that these guidelines actually changed their practice. Universal screening was the preferred screening approach (54%), followed by targeted screening (30%). For SCH diagnosis, most respondents (52%) endorsed a TSH level >2.5 mIU/L as a cutoff, whereas 5% endorsed a population-based cutoff as recommended by the ATA. The decision to initiate treatment varied depending on the specific clinical scenario; however, when LT4 was initiated, respondents expected a small/very small reduction in maternofetal complications. In conclusion, despite recently updated guidelines, there is still wide variation in clinical practices regarding the care of women with SCH in pregnancy. Highly reliable randomized trials are required to evaluate the effectiveness of the most uncertain treatment practices on the care of pregnant women with SCH.

9.
BMJ Open ; 9(9): e031259, 2019 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-31558457

RESUMO

OBJECTIVES: To improve the trustworthiness of evidence, studies should be prospectively registered and research reports should adhere to existing standards. We aimed to systematically assess the degree to which endocrinology and internal medicine journals endorse study registration and reporting standards for randomised controlled trials (RCTs), systematic reviews (SRs) and observational studies (ObS). Additionally, we evaluated characteristics that predict endorsement of reporting or registration mechanism by these journals. DESIGN: Meta-epidemiological study. SETTING: Journals included in the 'Endocrinology and Metabolism' and 'General and Internal Medicine' 2017 Journal Citation Reports. PARTICIPANTS: Journals with an impact factor of ≥1.0, focused on clinical medicine, and those who publish RCTs, SRs and ObS were included. PRIMARY OUTCOMES: Requirement of adherence to reporting guideline and study registration as determined from the journals' author instructions. RESULTS: Of the 170 (82 endocrinology and 88 internal medicine) eligible journals, endorsing of reporting standards was the highest for RCTs, with 35 (43%) of endocrine journals and 55 (63%) of internal medicine journals followed by SRs, with 21 (26%) and 48 (55%), respectively, and lastly, by ObS with 41 (50%) of endocrine journals and 21 (24%) of internal medicine journals. In 78 (46%) journals RCTs were required to be registered and published in adherence to the Consolidated Standards of Reporting Trials statement. Only 11 (6%) journals required registration of SRs. Internal medicine journals were more likely to endorse reporting guidelines than endocrine journals except for Strengthening the Reporting of Observational Studies in Epidemiology. No other journal characteristic proved to be an independent predictor of reporting standard endorsement for RCTs besides trial registration. CONCLUSION: Our results highlight that study registration requirement and reporting guideline endorsement are suboptimal in internal medicine and endocrine journals. This malpractice may be further enhanced since endorsement does not imply enforcement, impairing the practice of evidence-based medicine.

10.
11.
Endocr Pract ; 2019 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-31461355

RESUMO

ABSTRACT Objective: To evaluate the performance of morning serum cortisol (MSC) compared to a 10 µg ACTH stimulation test in the diagnosis of adrenal insufficiency (AI). Methods: A retrospective, cross-sectional analysis of ACTH stimulation tests were conducted. From a total of 312 potentially eligible ACTH stimulation tests, 306 met the inclusion criteria. The population was randomised into two groups, test (n: 159) and validation (n: 147). In the test group, the ROC-curve test evaluated the diagnostic performance of MSC. Results: A subnormal cortisol response to ACTH was found in 25.8% of the test group. The AUC values of MSC to predict AI at +30, +60 or maximal cortisol response were 0.874, 0.897, and 0.925 (95% CI 0.81-0.92, 0.83-0.93 and 0.87-0.96). Youden index was 234.2 mmol/L with sensitivity of 83.3% (95% CI 65.2 to 94.3%), and specificity of 89.1% (95% CI 82.4 to 93.9%). Positive and negative predictive values were 64.1% (95% CI 47.1 to 78.8%) and 95.8% (95% CI 90.5 to 98.6%). There was no difference in age, gender, AI prevalence or mean serum cortisol at +30, +60 in the validation group, however, a lower mean MSC value was found. Lower sensitivity and specificity values (88.3%, 60%) were found for the 234.2 mmol/L cutoff value. Conclusion: This study supports the role of MSC as a first-step diagnostic test in patients with clinically suspected AI. The short stimulation test could be omitted in almost half of the cases. Prospective and longitudinal studies to reproduce and confirm the cutoff values proposed are warranted.

12.
Am J Clin Pathol ; 152(4): 502-511, 2019 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-31305880

RESUMO

OBJECTIVES: Long-term follow-up is important for determining performance characteristics of thyroid fine-needle aspiration (FNA). METHODS: Histologic or 3 or more years of clinical follow-up was used to calculate performance characteristics of thyroid FNA before and after implementation of The Bethesda System for Reporting Thyroid Cytopathology (TBSRTC). The impact of noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) classification was also investigated. RESULTS: Follow-up was obtained for 1,277/1,134 and 1,616/1,393 aspirates/patients (median clinical follow-up, 9.9 and 4.4 years, pre- and post-TBSRTC, respectively). Nondiagnostic, suspicious for follicular neoplasm, and suspicious for malignancy (SFM) diagnoses decreased and benign diagnoses increased post-TBSRTC, while atypical rate remained less than 1%. Negative predictive value for benign nodules and positive predictive value (PPV) for SFM increased significantly. Eleven nodules were reclassified as NIFTP, slightly decreasing PPV/risk of malignancy (ROM). CONCLUSIONS: Appropriate ROM for thyroid FNA can be achieved through application of TBSRTC terminology with minimal use of atypical category.

13.
Artigo em Inglês | MEDLINE | ID: mdl-31127823

RESUMO

CONTEXT: Although thyroid hormone replacement may improve outcomes in pregnant women with subclinical hypothyroidism (SCH), the extent to which they receive treatment is unknown. OBJECTIVE: To describe levothyroxine (LT4) treatment practices for pregnant women with SCH. DESIGN: Retrospective cohort study. SETTING: Large U.S. administrative claims database. PARTICIPANTS: Pregnant women with SCH defined by untreated TSH 2.5-10 mIU/L. MAIN OUTCOME MEASURE: Initiation of LT4 as a function of treating clinician specialty (endocrinology, obstetrics/gynecology, primary care, or other), baseline TSH, patient clinical and demographic factors, and U.S. region. RESULTS: We identified 7,990 pregnant women with SCH; only 1,214 (15.2%) received LT4. Treatment was significantly more likely in patients with higher TSH, obesity, recurrent pregnancy loss, thyroid disease, and cared by endocrinologists. Proportion of treated women increased over time; LT4 treatment was twice as likely in 2014 as in 2010. Women in Northeast and West U.S. were significantly more likely to receive LT4 compared to other regions. Asian women were more likely, while Hispanic women were less likely, to receive LT4 compared to White women. Endocrinologists started LT4 at lower TSH thresholds than other specialties, and treated women who were more likely to have had recurrent pregnancy loss and thyroid disease than women treated by other clinicians. CONCLUSIONS: We found large variation in the prescription of LT4 to pregnant women with SCH, though most treatment-eligible women remained untreated. Therapy initiation is associated with geographic, clinician, and patient characteristics. This evidence can inform quality improvement efforts to optimize care for pregnant women with SCH.

14.
Syst Rev ; 8(1): 121, 2019 05 20.
Artigo em Inglês | MEDLINE | ID: mdl-31109357

RESUMO

BACKGROUND: Shared decision making (SDM) is a patient-centered approach in which clinicians and patients work together to find and choose the best course of action for each patient's particular situation. Six SDM key elements can be identified: situation diagnosis, choice awareness, option clarification, discussion of harms and benefits, deliberation of patient preferences, and making the decision. The International Patient Decision Aid Standards (IPDAS) require that a decision aid (DA) support these key elements. Yet, the extent to which DAs support these six key SDM elements and how this relates to their impact remain unknown. METHODS: We searched bibliographic databases (from inception until November 2017), reference lists of included studies, trial registries, and experts for randomized controlled trials of DAs in patients with cardiovascular, or chronic respiratory conditions or diabetes. Reviewers worked in duplicate and independently selected studies for inclusion, extracted trial, and DA characteristics, and evaluated the quality of each trial. RESULTS: DAs most commonly clarified options (20 of 20; 100%) and discussed their harms and benefits (18 of 20; 90%; unclear in two DAs); all six elements were clearly supported in 4 DAs (20%). We found no association between the presence of these elements and SDM outcomes. CONCLUSIONS: DAs for selected chronic conditions are mostly designed to transfer information about options and their harms and benefits. The extent to which their support of SDM key elements relates to their impact on SDM outcomes could not be ascertained. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number: CRD42016050320 .

16.
Int J Endocrinol ; 2019: 4784313, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30891069

RESUMO

Background: Hypertriglyceridemia and hyperglycemia coexist in 30-60% of patients with diabetes. The impact of hypertriglyceridemia regarding HbA1c assay reliability remains uncertain. Therefore, we conducted a prospective in vivo controlled study with the aim of defining the association between triglyceride levels and HbA1c. Methods: A total of 44 patients with an index-hospital admission diagnosis of diabetic ketoacidosis or hypertriglyceridemia-induced pancreatitis, as a model for acute elevation of triglycerides, were recruited. Blood samples were drawn for the measurement of HbA1c, triglycerides, glucose, and hemoglobin at baseline and subsequently 24 and 48 hours after admission. HbA1c analysis was performed with high-performance liquid chromatography Bio-Rad D10 (NGSP approved). Results: All patients completed the study protocol. A difference between mean triglycerides from day 0 (baseline) to day 2 of 1567.2 mg/dL was observed. We found a difference between mean serum HbA1c from days 0 to 2 of 0.09% [1 mmol/mol] (p = 0.004). Moreover, a weak correlation between the mean difference of HbA1c and triglycerides from baseline to day 2 was found to be statistically significant (r = 0.256, p = 0.015). None of these findings, however, are clinically significant. Conclusion: Triglycerides do not impair the interpretation of HbA1c assay. Patients and clinicians can now be confident that hypertriglyceridemia is not an important factor when interpreting HbA1c results.

17.
J Clin Endocrinol Metab ; 104(5): 1585-1594, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-30903687

RESUMO

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.

18.
J Clin Endocrinol Metab ; 104(5): 1575-1584, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-30903690

RESUMO

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.

19.
PLoS One ; 14(2): e0212360, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30779814

RESUMO

BACKGROUND: Trustworthy (i.e. low risk of bias) randomized clinical trials (RCTs) play an important role in evidence-based decision making. We aimed to systematically assess the risk of bias of trials published in high-impact endocrinology journals. METHODS: We searched the MEDLINE/PubMed database between 2014 and 2016 for phase 2-4 RCTs evaluating endocrine-related therapies. Reviewers working independently and in duplicate used the Cochrane Risk of Bias Tool (CCRBT) to determine the extent to which the methods reported protected the results of each RCT from bias. RESULTS: We assessed 292 eligible RCTs, of which 40% (116) were judged to be at low risk, 43% (126) at moderate, and 17% (50) at high risk of bias. Blinding of outcome assessment was the least common domain reported 43% (125), while selective reporting of outcomes was the most common 97% (282). In multivariable analysis, RCTs with a parallel design (OR 2.4; 95% CI; 1.2-4.6) and funded by for-profit sources (OR 2.2; 95% CI; 1.3-3.6) were more likely to be at low risk of bias. CONCLUSIONS: Trustworthy evidence should ultimately shape care to improve the likelihood of desirable patient outcomes. Six out-of 10 RCTs published in top endocrine journals are at moderate/high-risk of bias. Improving this should be a priority in endocrine research.


Assuntos
Doenças do Sistema Endócrino/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Doenças Ósseas/metabolismo , Doenças Ósseas/patologia , Doenças Ósseas/terapia , Doenças Cardiovasculares/metabolismo , Doenças Cardiovasculares/patologia , Doenças Cardiovasculares/terapia , Bases de Dados Factuais , Diabetes Mellitus/metabolismo , Diabetes Mellitus/patologia , Diabetes Mellitus/terapia , Doenças do Sistema Endócrino/metabolismo , Doenças do Sistema Endócrino/patologia , Humanos , Risco
20.
BMC Med Ethics ; 20(1): 2, 2019 01 08.
Artigo em Inglês | MEDLINE | ID: mdl-30621692

RESUMO

BACKGROUND: The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics. METHODS: A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. RESULTS: A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%, P = ≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%, P = < 0.001). The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%, P = 0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively). CONCLUSION: Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants.


Assuntos
Conscientização , Indústria Farmacêutica , Comitês de Ética em Pesquisa , Experimentação Humana/ética , Consentimento Livre e Esclarecido/ética , Sujeitos da Pesquisa/educação , Adulto , Idoso , Estudos de Casos e Controles , Conflito de Interesses/legislação & jurisprudência , Indústria Farmacêutica/ética , Indústria Farmacêutica/legislação & jurisprudência , Revisão Ética , Feminino , Guias como Assunto , Experimentação Humana/legislação & jurisprudência , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Masculino , México , Pessoa de Meia-Idade , Sujeitos da Pesquisa/psicologia , Adulto Jovem
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