An Obesity-Centric Approach with and Without Anti-Obesity Medications Compared to the Usual-Care Approach to Management of Patients with Obesity and Type 2 Diabetes in an Employer Setting: A Pragmatic Randomized Controlled Trial (EMPOWER-T2D).

INTRODUCTION: This study aimed to compare weight loss and glycated hemoglobin (HbA1c)-reduction effects of two obesity-centric, weight-loss management approaches (with or without anti-obesity medication) versus usual glucose-centric care in patients with obesity and type 2 diabetes. METHODS: Single-center, randomized, open-label, 3-armed, parallel-group, pragmatic, noninferiority trial, July 2020 to August 2022. Adults enrolled in the Cleveland Clinic Employee Health Plan (body mass index [BMI] ≥ 30 kg/m2, type 2 diabetes diagnosis, HbA1c > 7.5%) were randomized to usual glucose-centric management ("Usual-Care" group) or one of two obesity-centric management strategies: participation in a weight management program plus anti-obesity medication ("WMP + AOM" group), or WMP participation without anti-obesity medication ("WMP-Only" group). Primary endpoints were changes in weight and HbA1c, baseline to month 12. RESULTS: Due to enrollment and retention challenges, largely related to COVID-19, only 74/300 planned participants were randomized and the study was terminated early. Participants were predominantly female (59%), median (interquartile range [IQR]) age 53.5 (47, 60) years, 68% white, with baseline median (IQR) BMI and HbA1c of 37.4 (34.2, 42.7) kg/m2 and 8.8% (7.9%, 10.4%), respectively. At month 12, mean (90% confidence interval [CI]) percentage weight change in the Usual-Care, WMP-Only, and WMP + AOM groups was - 4.5% (- 6.5%, - 2.5%), - 6.7% (- 8.7%, - 4.7%), and - 8.7% (- 10.7%, - 6.8%), respectively; mean (90% CI) HbA1c change was - 1.7% (- 2.1%, - 1.2%), - 2.2% (- 2.7%, - 1.8%), and - 2.2% (- 2.6%, - 1.7%), respectively. WMP + AOM was superior to Usual-Care for weight change (P = 0.02); both WMP + AOM and WMP-Only were noninferior (P ≤ 0.01) to Usual-Care for change in HbA1c. CONCLUSIONS: Including anti-obesity medication was associated with superior weight loss with noninferior HbA1c reductions, warranting further evaluation in larger study populations of obesity-focused approaches to type 2 diabetes management. Graphical abstract available for this article. TRIAL REGISTRATION: ClinicalTrials.gov NCT03799198.

The use of virtual visits for obesity pharmacotherapy in patients with overweight or obesity compared with in-person encounters.

OBJECTIVE: This study aimed to demonstrate noninferiority using telehealth in treating obesity with phentermine in patients with BMI ≥ 27 kg/m2 with comorbidities or BMI ≥ 30 compared with the standard in-person approach over a 90-day period. METHODS: A 12-week, randomized, prospective, single-center, open label trial compared the use of virtual visits versus in-person visits for the treatment of obesity using phentermine. The primary end point was percentage mean change in body weight from baseline to 12 weeks. A noninferiority approach assuming a 3% noninferiority region was used to assess effect size differences. RESULTS: The weight loss in the virtual visit arm was noninferior to the in-person arm at all time points. At 12 weeks, the mean change in weight was -6.5% among the virtual group and -7.7% among the in-person group. In addition, 65% of virtual patients and 71% of in-person patients demonstrated a weight reduction of at least 5%. There was no difference in medication tolerance, adherence, and compliance. CONCLUSIONS: These results indicate that the virtual obesity pharmacotherapy visits in adults aged 18 to 65 years prescribed phentermine are effective and noninferior in achieving meaningful weight loss after 12 weeks. Future clinical trials are needed to better assess the effectiveness of televisits for obesity pharmacotherapy.

Perioperative management of diabetes in patients undergoing bariatric and metabolic surgery: a narrative review and the Cleveland Clinic practical recommendations.

Bariatric and metabolic surgery is an effective treatment for patients with severe obesity and obesity-related diseases. In patients with type 2 diabetes, it provides marked improvement in glycemic control and even remission of diabetes. In patients with type 1 diabetes, bariatric surgery may offer improvement in insulin sensitivity and other cardiometabolic risk factors, as well as amelioration of the mechanical complications of obesity. Because of these positive outcomes, there are increasing numbers of patients with diabetes who undergo bariatric surgical procedures each year. Prior to surgery, efforts should be made to optimize glycemic control. However, there is no need to delay or withhold bariatric surgery until a specific glycosylated hemoglobin target is reached. Instead, treatment should focus on avoidance of early postoperative hyperglycemia. In general, oral glucose-lowering medications and noninsulin injectables are not favored to control hyperglycemia in the inpatient setting. Hyperglycemia in the hospital is managed with insulin, aiming for perioperative blood glucose concentrations between 80 and 180 mg/dL. Following surgery, substantial changes of the antidiabetic medication regimens are common. Patients should have a clear understanding of the modifications made to their treatment and should be followed closely thereafter. In this review article, we describe practical recommendations for the perioperative management of diabetes in patients with type 2 or type 1 diabetes undergoing bariatric surgery. Specific recommendations are delineated based on the different treatments that are currently available for glycemic control, including oral glucose-lowering medications, noninsulin injectables, and a variety of insulin regimens.

Effectiveness of Combining Antiobesity Medication With an Employer-Based Weight Management Program for Treatment of Obesity: A Randomized Clinical Trial.

Importance: The clinical efficacy of antiobesity medications (AOMs) as adjuncts to lifestyle intervention is well characterized, but data regarding their use in conjunction with workplace wellness plans are lacking, and coverage of AOMs by US private employers is limited. Objective: To determine the effect of combining AOMs with a comprehensive, interdisciplinary, employer-based weight management program (WMP) compared with the WMP alone on weight loss, treatment adherence, and work productivity and limitations. Design, Setting, and Participants: This 1-year, single-center, open-label, parallel-group, real-world, randomized clinical trial was conducted at the Cleveland Clinic's Endocrinology and Metabolism Institute in Cleveland, Ohio, from January 7, 2019, to May 22, 2020. Participants were adults with obesity (body mass index [BMI; calculated as weight in kilograms divided by height in meters squared] ≥30) enrolled in the Cleveland Clinic Employee Health Plan. Interventions: In total, 200 participants were randomized 1:1, 100 participants to WMP combined with an AOM (WMP+Rx), and 100 participants to WMP alone. The WMP was the Cleveland Clinic Endocrinology and Metabolism Institute's employer-based integrated medical WMP implemented through monthly multidisciplinary shared medical appointments. Participants in the WMP+Rx group initiated treatment with 1 of 5 US Food and Drug Administration-approved medications for chronic weight management (orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, and liraglutide, 3.0 mg) according to standard clinical practice. Main Outcomes and Measures: The primary end point was the percentage change in body weight from baseline to month 12. Results: The 200 participants were predominately (177 of 200 [88.5%]) women, had a mean (SD) age of 50.0 (10.3) years, and a mean (SD) baseline weight of 105.0 (19.0) kg. For the primary intention-to-treat estimand, the estimated mean (SE) weight loss was -7.7% (0.7%) for the WMP+Rx group vs -4.2% (0.7%) for the WMP group, with an estimated treatment difference of -3.5% (95% CI, -5.5% to -1.5%) (P < .001). The estimated percentage of participants achieving at least 5% weight loss was 62.5% for WMP+Rx vs 44.8% for WMP (P = .02). The rate of attendance at shared medical appointments was higher for the WMP+Rx group than for the WMP group. No meaningful differences in patient-reported work productivity or limitation measures were observed. Conclusions and Relevance: Clinically meaningful superior mean weight loss was achieved when access to AOMs was provided in the real-world setting of an employer-based WMP, compared with the WMP alone. Such results may inform employer decisions regarding AOM coverage and guide best practices for comprehensive, interdisciplinary employer-based WMPs. Trial Registration: ClinicalTrials.gov Identifier: NCT03799198.

Survival in primary hyperparathyroidism over five decades (1965-2010) a population-based retrospective study.

CONTEXT: Survival in patients with primary hyperparathyroidism (PHPT) remains uncertain. OBJECTIVE: To update survival in patients with PHPT in a United States community population. DESIGN: Retrospective cohort study. SETTING: Community population in Rochester, Minnesota. PARTICIPANTS: Residents who met criteria for PHPT from 1965 to 2010. INTERVENTIONS: Survival was estimated using the Kaplan Meier product-limit method. The Cox proportional hazards model was used to determine associations, as relative hazards (RR) with 95% confidence intervals (CI), of various risk factors with time to death. MAIN OUTCOME MEASURE: The overall age and gender-adjusted survival compared to white Minnesota residents. RESULTS: We identified 1139 PHPT individuals, 76% female, with a median age of 58 years. Most were observed without parathyroidectomy (69%). The relative risk of death among the entire cohort was 0.996 (95% CI: 0.91-1.09, P = 0.935) which was not different compared to Minnesota residents. Those with maximum serum calcium level ≥ 10.8 mg/dL (0.7 mg/dL above the reference range) had an increase in mortality (RR 1.32, 95% CI: 1.10-1.58, P = 0.002). Survival among all PHPT individuals after parathyroidectomy was no different from expected (RR = 1.06, 95% CI 0.89-1.28; P = 0.508). Mortality was significantly decreased after parathyroidectomy in those with serum calcium levels ≥10.8 mg/dL (HR 0.47, 95% CI: 0.36-0.61, P < 0.001). CONCLUSIONS: Mortality in the entire cohort was not different from expected. PHPT patients with a maximum serum calcium level ≥ 10.8 mg/dL had increased mortality. Survival was improved after parathyroidectomy in those with this degree of hypercalcemia.

The importance of implementing inpatient virtual coverage in an endocrinology practice: lessons learned thus far from the COVID-19 pandemic.

The COVID-19 pandemic has rapidly changed the landscape of medical care and the healthcare system needs to quickly adapt in order to continue providing optimal medical care to hospitalized patients in an efficient, effective, and safe manner. Endocrinology diseases are commonly present in patients with COVID-19 and often are major risk factors for development of severe disease. The use of electronic consultation and telemedicine have already been well-established in the outpatient setting but yet not commonly implemented in the inpatient arena. This type of remote medical care has the potential to provide a reliable delivery of endocrine care while protecting providers and patients from spreading infection. This short review intends to provide the initial steps for the development of an inpatient telemedicine endocrine service to patients with endocrine diseases. Telehealth will become part of our daily practices and has a potential to provide a safe and efficient method of consultative service.

Association of prior metabolic and bariatric surgery with severity of coronavirus disease 2019 (COVID-19) in patients with obesity.

BACKGROUND: Obesity is a risk factor for poor clinical outcomes in patients with coronavirus disease 2019 (COVID-19). OBJECTIVES: To investigate the relationship between prior metabolic surgery and the severity of COVID-19 in patients with severe obesity. SETTING: Cleveland Clinic Health System in the United States. METHODS: Among 4365 patients who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) between March 8, 2020 and July 22, 2020 in the Cleveland Clinic Health System, 33 patients were identified who had a prior history of metabolic surgery. The surgical patients were propensity matched 1:10 to nonsurgical patients to assemble a cohort of control patients (n = 330) with a body mass index (BMI) ≥ 40 kg/m2 at the time of SARS-CoV-2 testing. The primary endpoint was the rate of hospital admission. The exploratory endpoints included admission to the intensive care unit (ICU), need for mechanical ventilation and dialysis during index hospitalization, and mortality. After propensity score matching, outcomes were compared in univariate and multivariate regression models. RESULTS: The average BMI of the surgical group was 49.1 ± 8.8 kg/m2 before metabolic surgery and was down to 37.2 ± 7.1 at the time of SARS-CoV-2 testing, compared with the control group's BMI of 46.7 ± 6.4 kg/m2. In the univariate analysis, 6 (18.2%) patients in the metabolic surgery group and 139 (42.1%) patients in the control group were admitted to the hospital (P = .013). In the multivariate analysis, a prior history of metabolic surgery was associated with a lower hospital admission rate compared with control patients with obesity (odds ratio, 0.31; 95% confidence interval, 0.11-0.88; P = .028). While none of the 4 exploratory outcomes occurred in the metabolic surgery group, 43 (13.0%) patients in the control group required ICU admission (P = .021), 22 (6.7%) required mechanical ventilation, 5 (1.5%) required dialysis, and 8 (2.4%) patients died. CONCLUSION: Prior metabolic surgery with subsequent weight loss and improvement of metabolic abnormalities was associated with lower rates of hospital and ICU admission in patients with obesity who became infected with SARS-CoV-2. Confirmation of these findings will require larger studies.

Thiazide-Associated Hypercalcemia: Incidence and Association With Primary Hyperparathyroidism Over Two Decades.

CONTEXT: Thiazide diuretics, the antihypertensive agent prescribed most frequently worldwide, are commonly associated with hypercalcemia. However, the epidemiology and clinical features are poorly understood. OBJECTIVE: To update the incidence of thiazide-associated hypercalcemia and clarify its clinical features. PATIENTS AND METHODS: In a population-based descriptive study, Olmsted County, Minnesota, residents with thiazide-associated hypercalcemia were identified through the Rochester Epidemiology Project and the Mayo Clinic Laboratory Information System from 2002-2010 and were added to the historical cohort beginning in 1992. MAIN OUTCOME: Incidence rates were adjusted to the 2010 United States white population. RESULTS: Overall, 221 Olmsted County residents were identified with thiazide-associated hypercalcemia an average of 5.2 years after initiation of treatment. Subjects were older (mean age, 67 years) and primarily women (86.4%). The incidence of thiazide-associated hypercalcemia increased after 1997 and peaked in 2006 with an annual incidence of 20 per 100,000, compared to an overall rate of 12 per 100,000 in 1992-2010. Severe hypercalcemia was not observed in the cohort despite continuation of thiazide treatment in 62.4%. Of patients discontinuing thiazides, 71% continued to have hypercalcemia. Primary hyperparathyroidism was diagnosed in 53 patients (24%), including five patients who underwent parathyroidectomy without thiazide discontinuation. CONCLUSIONS: Many patients with thiazide-associated hypercalcemia have underlying primary hyperparathyroidism. Additionally, a sharp rise in thiazide-associated hypercalcemia incidence began in 1998, paralleling the increase observed in primary hyperparathyroidism in this community. Case ascertainment bias from targeted osteoporosis screening is the most likely explanation.

Systematic reviews with language restrictions and no author contact have lower overall credibility: a methodology study.

BACKGROUND: High-quality systematic reviews (SRs) require rigorous approaches to identify, appraise, select, and synthesize research evidence relevant to a specific question. In this study, we evaluated the association between two steps in the conduct of an SR - restricting the search to English, and author contact for missing data - and the overall credibility of a SR. METHODS: All SRs cited by the Endocrine Society's Clinical Practice Guidelines published from October 2006 through January 2012 were included. The main outcome was the overall A Measurement Tool to Assess Systematic Reviews (AMSTAR) score, as a surrogate of SR credibility. Nonparametric Kruskal-Wallis tests and multivariable linear regression models were used to investigate the association between language restriction, author contact for missing data, and the overall AMSTAR score. RESULTS: In all, 69 SRs were included in the analysis. Only 31 SRs (45%) reported searching non-English literature, with an average AMSTAR score of 7.90 (standard deviation [SD] =1.64). SRs that reported language restriction received significantly lower AMSTAR scores (mean =5.25, SD =2.32) (P<0.001). Only 30 SRs (43%) reported contacting authors for missing data, and these received, on average, 2.59 more AMSTAR points (SD =1.95) than those who did not (P<0.001). In multivariable analyses, AMSTAR score was significantly correlated with language restriction (beta =-1.31, 95% confidence interval [CI]: -2.62, -0.01, P=0.05) and author contact for missing data (beta =2.16, 95% CI: 0.91, 3.41, P=0.001). However, after adjusting for compliance with reporting guidelines, language restriction was no longer significantly associated with the AMSTAR score. CONCLUSION: Fewer than half of the SRs conducted to support the clinical practice guidelines we examined reported contacting study authors or searched non-English literature. SRs that did not conduct these two steps had lower quality scores, suggesting the importance of these two steps for overall SR credibility.

Secular trends in the incidence of primary hyperparathyroidism over five decades (1965-2010).

Introduction of automated serum calcium measurements in the 1970s resulted in a sharp rise in primary hyperparathyroidism (PHPT) incidence. However, recent investigations suggest a significant rise in PHPT incidence for unclear reasons. Our objective was to update our population-based secular trends in PHPT incidence, to determine if there has been a significant rise in PHPT incidence as suggested by others, and, if possible, to identify changes in clinical practice that might be responsible. Rochester, Minnesota, residents who met the criteria for PHPT from 2002 through 2010 were identified through the medical records-linkage system of the Rochester Epidemiology Project and added to the historical cohort beginning in 1965. Incidence rates were adjusted to the 2010 US white population. Altogether, 1142 Rochester residents have been diagnosed with PHPT since 1965, including 341 in 2002-2010. Over time, two periods of increased PHPT incidence occurred, one beginning in 1974 (121.7 per 100,000 person-years) and a second peak (86.2 per 100,000 person-years) starting in 1998. The median age of PHPT subjects has increased significantly from 55 years in 1985-1997 to 60 years of age in 1998-2010 and more patients (36%) had a parathyroidectomy in 1998-2010. Although serum calcium measurement has declined since 1996, there was a progressive increase in parathyroid hormone testing between 1994 and 2008. There was also a rise in orders for bone mineral density measurements in women since 1998, which peaked in 2003-2004. A second sharp rise in PHPT incidence occurred in our community in 1998, simultaneously with the introduction of national osteoporosis screening guidelines, Medicare coverage for bone density measurement, and new medications for the treatment of osteoporosis. Case ascertainment bias from targeted PHPT screening in patients being evaluated for osteoporosis is the most likely explanation.

Metastasis to the thyroid gland: report of a large series from the Mayo Clinic.

OBJECTIVES: Metastases to the thyroid gland are not as unusual as previously believed. This study reports the largest number of patients with metastatic disease of the thyroid to date, confirms the accuracy of fine-needle aspiration (FNA) in diagnosing metastasis, and reviews the incidence and management through our institutional experience. METHODS: This study entailed review of all thyroid FNAs performed at Mayo Clinic, Rochester during the period 1980 to 2010 and identified 97 patients with a metastatic solid neoplasm of the thyroid gland. RESULTS: Frequent primary tumor sites included kidney (22%), lung (22%), and head and neck (12%). The median age at discovery of thyroid metastasis was 63 years. The time from diagnosis of primary tumor to metastasis to the thyroid gland was most considerable for renal cell carcinoma (mean 113 mo). Forty-one patients underwent thyroid resection with an average tumor size of 3 cm. Median survival in all patients with metastases was 20 months (range, 1 to 228 mo). Patients who underwent thyroid resection had a median survival of 30 months (range, 3 to 171 mo), whereas survival in patients without thyroid surgery was 12 months (range, 1 to 228 mo, log-rank test P=0.09). CONCLUSIONS: Our experience over the last 30 years confirms that FNA remains a sensitive and specific method to detect metastases to the thyroid. In any patient with a history of a malignancy, a new thyroid mass should be promptly evaluated for recurrent malignancy as early diagnosis and surgical resection resulted in a nonstatistically significant increased median survival.

Pharmacologic interventions for painful diabetic neuropathy: An umbrella systematic review and comparative effectiveness network meta-analysis.

BACKGROUND: Multiple treatments for painful diabetic peripheral neuropathy are available. PURPOSE: To evaluate the comparative effectiveness of oral and topical analgesics for diabetic neuropathy. DATA SOURCES: Multiple electronic databases between January 2007 and April 2014, without language restriction. STUDY SELECTION: Parallel or crossover randomized, controlled trials that evaluated pharmacologic treatments for adults with painful diabetic peripheral neuropathy. DATA EXTRACTION: Duplicate extraction of study data and assessment of risk of bias. DATA SYNTHESIS: 65 randomized, controlled trials involving 12 632 patients evaluated 27 pharmacologic interventions. Approximately one half of these studies had high or unclear risk of bias. Nine head-to-head trials showed greater pain reduction associated with serotonin-norepinephrine reuptake inhibitors (SNRIs) than anticonvulsants (standardized mean difference [SMD], -0.34 [95% credible interval {CrI}, -0.63 to -0.05]) and with tricyclic antidepressants (TCAs) than topical capsaicin 0.075%. Network meta-analysis showed that SNRIs (SMD, -1.36 [CrI, -1.77 to -0.95]), topical capsaicin (SMD, -0.91 [CrI, -1.18 to -0.08]), TCAs (SMD, -0.78 [CrI, -1.24 to -0.33]), and anticonvulsants (SMD, -0.67 [CrI, -0.97 to -0.37]) were better than placebo for short-term pain control. Specifically, carbamazepine (SMD, -1.57 [CrI, -2.83 to -0.31]), venlafaxine (SMD, -1.53 [CrI, -2.41 to -0.65]), duloxetine (SMD, -1.33 [CrI, -1.82 to -0.86]), and amitriptyline (SMD, -0.72 [CrI, -1.35 to -0.08]) were more effective than placebo. Adverse effects included somnolence and dizziness with TCAs, SNRIs, and anticonvulsants; xerostomia with TCAs; and peripheral edema and burning sensation with pregabalin and capsaicin. LIMITATION: Confidence in findings was limited because most evidence came from indirect comparisons of trials with short (≤3 months) follow-up and unclear or high risk of bias. CONCLUSION: Several medications may be effective for short-term management of painful diabetic neuropathy, although their comparative effectiveness is unclear. PRIMARY FUNDING SOURCE: Mayo Foundation for Medical Education and Research.

Systematic reviews supporting practice guideline recommendations lack protection against bias.

OBJECTIVE: To evaluate the quality of systematic reviews (SRs) affecting clinical practice in endocrinology. STUDY DESIGN AND SETTING: We identified all SRs cited in The Endocrine Society's Clinical Practice Guidelines published between 2006 and January 2012. We evaluated the methodological and reporting quality of the SRs in duplicate using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. We also noted if the guidelines recommendations that are clearly supported by SRs acknowledged their quality. RESULTS: During the 5-year period of study, endocrine guidelines cited 69 SRs. These SRs had a mean AMSTAR score of 6.4 (standard deviation, 2.5) of a maximum score of 11, with scores improving over time. SRs of randomized trials had higher AMSTAR scores than those of observational studies. Low-quality SRs (methodological AMSTAR score 1 or 2 of 5, n = 24, 35%) were cited in 24 different recommendations and were the main evidentiary support for five recommendations, of which only one acknowledged the quality of SRs. CONCLUSION: Few recommendations in endocrinology are supported by SRs. The quality of SRs is suboptimal and is not acknowledged by guideline developers.

Medullary thyroid carcinoma.

OBJECTIVE: This review outlines advances in the diagnosis, genetic testing, and progress in medullary thyroid cancer (MTC) treatment in light of the most recent evidence. METHODS: English-language articles pertaining to MTC published up to 2012 were reviewed. The pertinent articles and their references were obtained and those considered relevant were reviewed for inclusion. RESULTS: MTC is an uncommon neuroendocrine malignancy that accounts for 5% of thyroid cancers. MTC presents in sporadic and familial forms (multiple endocrine neoplasia [MEN] 2A, MEN 2B, or familial MTC syndromes). The familial forms are secondary to germline mutations in the REarranged during Transfection (RET) proto-oncogene. Early diagnosis and treatment is paramount. Genetic testing has made possible early detection in asymptomatic carriers and high-risk patients, with early or prophylactic surgery being curative in many. All carriers of an RET mutation should be evaluated and treated surgically for MTC. The primary treatment in all patients diagnosed with MTC is total thyroidectomy with central lymph node dissection. Calcitonin and carcinoembryonic antigen levels can be used as prognostic factors and as tumor markers. If elevated, further investigation, including use of imaging modalities, may be necessary for evaluation of metastatic disease. Surgery remains the main treatment for local and locally advanced disease. CONCLUSION: MTC is rare, but morbidity and mortality remain high if untreated. Genetic testing should be offered to all patients. Treatment of choice remains total thyroidectomy and central lymph node dissection. Palliative treatment for advanced disease includes surgery, radiation, standard chemotherapy, chemoembolization and more recently, targeted therapies (tyrosine kinase inhibitors).

Pharmacologic interventions for painful diabetic neuropathy: an umbrella systematic review and comparative effectiveness network meta-analysis (Protocol).

BACKGROUND: Neuropathic pain can reduce the quality of life and independence of 30% to 50% of patients with diabetes. The comparative effectiveness of analgesics for patients with diabetic neuropathy remains unclear. The aim of the current work, therefore, was to summarize the evidence about the analgesic effectiveness of the most common oral and topical agents used for the treatment of peripheral diabetic neuropathy. METHODS: We will use an umbrella approach (systematic review of systematic reviews) to identify eligible randomized controlled trials (RCTs) for the most common oral or topical analgesics for painful diabetic neuropathy. Two reviewers will independently determine RCT eligibility. Disagreement will be solved by consensus and arbitrated by a third reviewer. We will extract descriptive, methodological and efficacy data in duplicate. Results will be pooled and analyzed using classic random-effects meta-analyses and network meta-analyses to compute the absolute and relative efficacy of therapeutic options. We will use the I2 statistic and Cochran's Q test to assess heterogeneity. Risk of bias and publication bias, if appropriate, will be evaluated, as well as overall strength of the evidence. DISCUSSION: This network meta-analysis aims to synthesize available direct and indirect evidence of effectiveness of analgesics in the treatment of painful diabetic neuropathy. The network approach will offer the opportunity to generate a ranking based on efficacy and along with known side effects, costs, and administration burdens will enable patients and clinicians to make choices that best reflect their preferences for treatment of painful diabetic neuropathy.

Self-reported versus measured height and weight in Hispanic and non-Hispanic menopausal women.

BACKGROUND: Height and weight information is commonly used in clinical trials and in making therapeutic decisions in medical practice. In both settings, the data are often obtained by self-report. If erroneous, this practice could lead to inaccuracies in estimating renal function and medication doses or to inaccurate outcomes of research studies. Previous publications have reported lack of reliability of self-reported weight and height in the general population but have not addressed age-specific and ethnicity-specific subgroups in the U.S. population. The inaccuracy of self-reported weight and height could be particularly significant in times of considerable changes in body weight, such as at menopause, which is often associated with weight gain. METHODS: We assessed the validity of self-reported height and weight in 428 women within the first 5 years of menopause, 70.6% of whom were Hispanic. RESULTS: Participants overestimated their height by 2.2±3.5 cm (mean±standard deviation [SD]) and underestimated their weight by 1.5±2.9 kg. As a group, based on self-reported measures, 33.3% were misclassified with respect to body mass index (BMI) category, and the difference between measured BMI and self-reported BMI was similar between Hispanic white and non-Hispanic white women, positively related to measured weight, and inversely related to measured height, years from menopause, and multiple parity. CONCLUSIONS: From the public health perspective, inaccurate self-report could lead to a considerable underestimation of the current obesity prevalence rates. In our study population, the prevalence of obesity (BMI ≥30 kg/m(2)) was 6.3% based on self-reported values and 18% based on measured height and weight, representing a 3-fold underestimation.