Rene Rodriguez-Gutierrez

Thyroid hormone treatment among pregnant women with subclinical hypothyroidism: US national assessment

Objective To estimate the effectiveness and safety of thyroid hormone treatment among pregnant women with subclinical hypothyroidism. Design Retrospective cohort study. Setting Large US administrative database between 1 January 2010 and 31 December 2014. Participants 5405 pregnant women with subclinical hypothyroidism, defined as untreated thyroid stimulating hormone (TSH) concentration 2.5-10 mIU/L. Exposure Thyroid hormone therapy. Main outcome measure Pregnancy loss and other pre-specified maternal and fetal pregnancy related adverse outcomes. Results Among 5405 pregnant women with subclinical hypothyroidism, 843 with a mean pre-treatment TSH concentration of 4.8 (SD 1.7) mIU/L were treated with thyroid hormone and 4562 with a mean baseline TSH concentration of 3.3 (SD 0.9) mIU/L were not treated (P<0.01). Pregnancy loss was significantly less common among treated women (n=89; 10.6%) than among untreated women (n=614; 13.5%) (P<0.01). Compared with the untreated group, treated women had lower adjusted odds of pregnancy loss (odds ratio 0.62, 95% confidence interval 0.48 to 0.82) but higher odds of preterm delivery (1.60, 1.14 to 2.24), gestational diabetes (1.37, 1.05 to 1.79), and pre-eclampsia (1.61, 1.10 to 2.37); other pregnancy related adverse outcomes were similar between the two groups. The adjusted odds of pregnancy loss were lower in treated women than in untreated women if their pre-treatment TSH concentration was 4.1-10 mIU/L (odds ratio 0.45, 0.30 to 0.65) but not if it was 2.5-4.0 mIU/L (0.91, 0.65 to 1.23) (P<0.01). Conclusion Thyroid hormone treatment was associated with decreased risk of pregnancy loss among women with subclinical hypothyroidism, especially those with pre-treatment TSH concentrations of 4.1-10 mIU/L. However, the increased risk of other pregnancy related adverse outcomes calls for additional studies evaluating the safety of thyroid hormone treatment in this patient population.

Patient capacity and constraints in the experience of chronic disease: A qualitative systematic review and thematic synthesis

BackgroundLife and healthcare demand work from patients, more so from patients living with multimorbidity. Patients must respond by mobilizing available abilities and resources, their so-called capacity. We sought to summarize accounts of challenges that reduce patient capacity to access or use healthcare or to enact self-care while carrying out their lives.MethodsWe conducted a systematic review and synthesis of the qualitative literature published since 2000 identifying from MEDLINE, EMBASE, Psychinfo, and CINAHL and retrieving selected abstracts for full text assessment for inclusion. After assessing their methodological rigor, we coded their results using a thematic synthesis approach.ResultsThe 110 reports selected, when synthesized, showed that patient capacity is an accomplishment of interaction with (1) the process of rewriting their biographies and making meaningful lives in the face of chronic condition(s); (2) the mobilization of resources; (3) healthcare and self-care tasks, particularly, the cognitive, emotional, and experiential results of accomplishing these tasks despite competing priorities; (4) their social networks; and (5) their environment, particularly when they encountered kindness or empathy about their condition and a feasible treatment plan.ConclusionPatient capacity is a complex and dynamic construct that exceeds “resources” alone. Additional work needs to translate this emerging theory into useful practice for which we propose a clinical mnemonic (BREWS) and the ICAN Discussion Aid.

Hypoglycemia as an indicator of good diabetes care

Rene Rodriguez-Gutierrez and colleagues argue that more attention should be paid to hypoglycemia when assessing management of diabetes

Shared Decision-Making in Diabetes Care.

Shared decision-making (SDM) is a collaborative process by which patients and clinicians work together in a deliberative dialogue. The purpose of this dialogue is to identify reasonable management options that best fit and addresses the unique situation of the patient. SDM supports the patient-centered translation of research into practice. SDM also helps implement a core principle of evidence-based medicine: evidence is necessary but never sufficient to make a clinical decision, as consideration of patient values and context is also required. SDM conversations build on a partnership between the patient and the clinician, draw on the body of evidence with regard to the different treatment options, and consider options in light of the values, preferences, and context of the patient. SDM is appropriate for diabetes care because diabetes care often requires consideration of management options that differ in ways that matter to patients, such as the way in which they place significant demands on patient’s life and living. In the last decade, SDM has proven feasible and useful for sharing evidence with patients and for involving patients in making decisions with their clinicians. Health care and clinical policies advocate SDM, but these policies have yet to impact diabetes care. In this paper, we describe what SDM is, its known impact on diabetes care, and needed work to implement this patient-centered approach in the care of the millions of patients with diabetes.

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.

Shared decision-making in the care of individuals with diabetes

People with diabetes often live with other chronic conditions and lead complicated lives. Determining what is the best management decision for a patient requires consideration of each individuals personal, social and biomedical context, what he or she values, the reasons he or she has to value the available options, and the relative contribution of each option in terms of benefits, harms, costs and inconveniences. Empathic conversations between patients and clinicians to diagnose the patient situation that necessitates action and the range of evidence‐based actions that best address the situation, so‐called shared decision‐making, are essential to the personalized care of people with diabetes. The aim of the present review was to present key elements of shared decision‐making and propose three different approaches for its application. The first approach focuses on transferring information to patients so that they can make decisions. The second approach, choice, focuses on cultivating the individuals ability to give voice to which choice is best for them. The third approach, conversation, establishes an empathic conversational environment through which the individual with diabetes and their clinician think and talk through how to address the problems of living with diabetes and related illnesses. These approaches are manifest in the design of evidence‐based decision aids created to support shared decision‐making. In randomized trials, decision aids can efficiently improve patients knowledge, satisfaction, risk awareness, decisional conflict and involvement. Further research, however, is needed to better understand when and how to promote the empathic conversations, patient, clinician and service and policy contexts necessary to routinely implement shared decision‐making in different at scale healthcare systems. In the interim, sufficient evidence and tools exist for persons with diabetes and their clinicians to gain expertise in making decisions together.

What we don't talk about when we talk about preventing type 2 diabetes - Addressing socioeconomic disadvantage

About half of the adults in the United States have either diabetes (mostly type 2), or prediabetes.1 Societies across the globe have been generating people living with diabetes at a fast pace, a pace that shows signs of stabilizing in the United States.1 Yet, there is a sustained increase in the incidence of diabetes in people with lower socioeconomic status.1 That a rampant diabetes epidemic is preferentially impacting the disadvantaged shines light on the problematic way in which we have chosen to respond. This approach—to prevent diabetes 1 person at a time—has hampered our response as a society to the diabetes epidemic. The substantial investment of resources in a unidimensional strategy, despite limited evidence of benefit, threatens the viability of health care systems (ie, their ability to meet expanded needs of the population with constrained resources), and sets an ineffective precedent for the way that we address epidemics. The Centers for Disease Control (CDC) and the American Medical Association (AMA), as well as Congress, UnitedHealthcare and other insurers, employers and other community agencies, have invested in implementing programs that require clinicians to identify people who are at risk for diabetes and to refer each of them to community partners, such as local YMCAs, to take part in a year-long intensive intervention to modify diet and activity. For these interventions to succeed, long-term and constant effort is necessary from clinicians and the individuals at risk.2,3 Importantly, these efforts do not have an effect on the underlying conditions—poverty, income inequality, loneliness, and socioeconomic stress—that are conducive to more obesity and more cases of diabetes. A more considerate and broad approach to diabetes prevention is needed, an approach that does not place the responsibility for prevention solely on the willpower of individuals and which addresses the diabetogenicity of our societies.

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.

Inclusion of Hypoglycemia in Clinical Practice Guidelines and Performance Measures in the Care of Patients With Diabetes

HEALTH CARE POLICY AND LAW Inclusion of Hypoglycemia in Clinical Practice Guidelines and Performance Measures in the Care of Patients With Diabetes Health care organizations use publicly reported performance measures for quality measurement and improvement and payfor-performance initiatives.1 These measures should ideally promote high-quality care that is evidence based and congruent with clinical practice guidelines. However, they should also reward patient-centered care that yields optimal outcomes with the lowest risk of harm.2 For patients with both type 1 and type 2 diabetes, high-quality care should therefore minimize the risk of hypoglycemia.2 The degree to which existing performance measures are aligned with guidelines, particularly in regard to hypoglycemia avoidance, is uncertain. We therefore conducted an environmental scan to assess the inclusion and prioritization of hypoglycemia in contemporary clinical guidelines and performance measures for patients with diabetes.

Is the endocrine research pipeline broken? A systematic evaluation of the Endocrine Society clinical practice guidelines and trial registration

BackgroundVery low quality (VLQ) evidence translates into very low confidence in the balance of risk and benefits based on the estimates drawn from the body of evidence. Consequently, this assessment highlights gaps in the research evidence, i.e. knowledge gaps, for important clinical questions. In this way, expert guideline panels identify priority knowledge gaps that, arguably, should inform the research agenda and prioritize scarce research economical resources. The extent to which the research agenda reflects the knowledge gaps identified in clinical practice guidelines is unknown.MethodsA systematic evaluation of the Endocrine Society (ES) clinical practice guidelines portfolio from 2008 to 2014 was conducted with the objectives to identify (1) recommendations in the ES clinical practice guidelines based on VLQ evidence reflecting knowledge gaps in endocrinology, and (2) active research designed to address these gaps by searching the clinical trial registry, clinicaltrials.gov, using terms describing patients (diseases), interventions, comparison, and outcomes.ResultsIn 25 ES guidelines, we found 660 recommendations, of which 131 (20 %) were supported by VLQ evidence. Clinical trialists are attempting to answer 28 (21 %) of these knowledge gaps by performing 69 clinical trials.ConclusionThe research enterprise is addressing one in five knowledge gaps identified in clinical practice recommendations in endocrinology. These findings suggest an inefficiency in the allocation of very scarce research economical resources. Linking the research agenda to evidence gaps in clinical practice guidelines may improve both the efficiency of the research enterprise and the translation of evidence into more confident clinical practice.