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Background: We assessed the prevalence of complications from percutaneous ethanol injection (PEI) for benign and cystic thyroid nodules (CTNs) and their management. Methods: We conducted a systematic review with meta-analysis of data from published observational studies on PEI of CTNs. We also included unpublished retrospectively collected data on complications after PEI from all consecutive patients with cytologically benign CTNs who underwent PEI at the Unit of Endocrinology and Metabolic Diseases, AOU University of Campania Luigi Vanvitelli (Naples, Italy) between June 1, 2021, and March 31, 2024. A random effects meta-analysis was performed on the prevalence rate data. Pooled prevalence data were presented with confidence intervals (CIs). The I2 statistic index was used to quantify the heterogeneity. The details of the complications and the management were qualitatively described. Results: The literature search yielded 1189 studies, of which 48 studies were included in the systematic review and meta-analysis, in addition to our institutional experience (3670 CTNs in total). The overall quality of each included study was judged as fair. The prevalence of "Overall" complications of PEI was 32% ([CI 25-40%], I2 92.7%, 967 of 3195 thyroid nodules [TNs]). The prevalence of "Minor" complications of PEI was 32% ([CI 25-40%], I2 92.7%, 952 of 3195 TNs). The prevalence of "Major" complications of PEI was 2% ([CI 1-2%], I2 0%, 22 of 3670 TNs). Sensitivity analyses did not modify the results. The pooled prevalence rate of local pain was 21% (CI [16-27] I2 90.3). Local pain was typically transient and mild, sometimes moderate, and requiring analgesics for few days. The pooled prevalence rate of dysphonia was 1% (CI [1-2], I2 0). Dysphonia was transient and could last from several hours to 12 months after PEI. Conclusions: Complications of PEI for benign and CTNs are relatively common, but most are minor and usually transient, not requiring treatment. Dysphonia was a major complication, but it was uncommon and transient. PEI for CTNs could be considered a generally safe technique.

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PURPOSE: The aim of this study was to evaluate the diagnostic value of four commonly utilized ultrasound (US) RSSs, namely, the American College of Radiology [ACR], European [EU], Korean [K] TI-RADSs and American Thyroid Association [ATA] US-based RSS criteria, in combination with activating point mutations of the RAS genes (NRAS, HRAS, and KRAS) for detection of thyroid carcinoma in cytologically indeterminate and suspicious for malignancy thyroid nodules. METHODS: We retrospectively analyzed cytologically indeterminate and suspicious for malignancy thyroid nodules which underwent US, molecular testing and surgery between September 1, 2018, and December 31, 2023. Receiver operating characteristic (ROC) curves were generated, and the area under the curve (AUC, 95% confidence interval [CI]) was calculated. RESULTS: A total of 100 cytologically indeterminate and 24 suspicious for malignancy thyroid nodules were analyzed. Compared to the four US-based RSSs alone, the diagnostic value of the four US-based RSSs combined with RAS mutations did not significantly improved (cytologically indeterminate, AUC [95% CI] 0.6 [0.5-0.7] and 0.6 [0.5-0.7], respectively, p = 0.70; cytologically suspicious for malignancy, AUC [95% CI] 0.7 [0.5-0.9] and 0.8 [0.6-0.9], respectively, p = 0.23). CONCLUSIONS: The diagnostic value of the four main US-based RSSs (ACR, EU, K, and ATA) was not improved in conjunction with the evaluation of RAS mutations for preoperative risk stratification of cytologically indeterminate thyroid nodules. CLINICAL RELEVANCE STATEMENT: In cytologically indeterminate nodules categorized according to US-based RSSs, isolated RAS positivity does not reliably distinguish between benignity and malignancy.

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Background: Acute kidney injury (AKI) is associated with increased complications after total hip arthroplasty (THA) and total knee arthroplasty (TKA). The purpose of this study was to determine the risk factors for AKI after THA and TKA and evaluate if preoperative use of antihypertensive drugs is a risk factor for AKI. Methods: A retrospective review of 7406 primary TKAs and THAs (4532 hips and 2874 knees) from 2013 to 2019 was performed. The following preoperative variables were obtained from medical records: medications, chemistry 7 panel, Elixhauser comorbidities, and demographic factors. AKI was defined as an increase in serum creatinine by 26.4 µmol·L-1. Multivariate analysis was performed to identify the risk factors. Results: The overall incidence of postoperative AKI was 6.2% (n = 459). Risk factors for postoperative AKI were found to be: chronic kidney disease (odds ratio [OR] = 7.09; 95% confidence interval [CI]: 4.8-9.4), diabetes (OR: 5.03; 95% CI: 2.8-6.06), ≥3 antihypertensive drugs (OR: 4.2; 95% CI: 2.1-6.2), preoperative use of an angiotensin receptor blockers or angiotensin-converting enzyme inhibitors (OR: 3.8; 95% CI: 2.2-5.9), perioperative vancomycin (OR: 2.7; 95% CI: 1.8-4.6), and body mass index >40 kg/m2 (OR: 1.9; 95% CI: 1.3-3.06). Conclusions: We have identified several modifiable risk factors for AKI that can be optimized prior to an elective THA or TKA. The use of certain antihypertensive agents namely angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and multidrug antihypertensive regimens were found to significantly increase the risk of AKI. Therefore, perioperative management of patients undergoing joint replacement should include medical comanagement with a focus on careful management of antihypertensives.

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STATEMENT OF PROBLEM: The clinical survival of different types of post-and-core systems requires assessment. PURPOSE: The purpose of this retrospective clinical study was to evaluate the clinical survival rate (CSR) of custom-fabricated cast metal and prefabricated (both metal- and fiber-reinforced composite resin post) post-and-cores as a function of patient- and restoration-related variables. MATERIAL AND METHODS: A retrospective analysis was conducted on electronic charts indicating that these patients had received some type of post-and-core between January 2003 and January 2018. A total of 754 records were included in the analysis based on the inclusion criteria. Data were analyzed by using the Kaplan-Meier and Cox proportional hazards analysis. RESULTS: Kaplan-Meier analysis demonstrated the mean survival time for each group to be 12.0 years for fiber-reinforced composite resin posts, 11.8 years for cast metal post-and-cores, and 10.2 years for prefabricated metal posts. Although the mean survival time differed by 1.8 years among groups, with prefabricated metal posts having a slightly higher risk of failure, this effect was not statistically significant (P=.067). The effect of post type also failed to reach significance when controlling for patient demographics and post position in a Cox proportional hazards analysis (P=.106). However, the Cox model did show that survival was associated with tooth position (P=.003), cement (P=.021), and type of restoration (P<.001). CONCLUSIONS: Analysis showed no evidence that post-and-core survival was significantly associated with 3 types of post-and-cores (custom-fabricated metal, prefabricated metal, and prefabricated fiber-reinforced composite resin). The percentage of root in the bone, tooth position, cement, and type of restoration, however, were significantly associated with survival.

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Diabetes mellitus is a well-established risk factor for postoperative complications of total joint arthroplasty (TJA). We conducted a study to identify a specific hemoglobin A1c (HbA1c) level at which immediate postoperative complication rates increased after TJA. HbA1c levels were measured within 90 days preoperatively. Complications were documented during the acute postoperative period. Charts were reviewed, and each patient was given a score based on how many of these postoperative complications occurred. Overall, 1118 patients were retrospectively analyzed between 2009 and 2011. Patients were grouped into 5 HbA1c level ranges, and a mean postoperative complication point score was obtained for each group. We found that mean postoperative complication rates increased along with HbA1c levels; HbA1c levels higher than 7.5% correlate strongly with a higher rate of postoperative complications. These findings provide a good foundation for prospective studies and further evidence of the effects of HbA1c levels. If an adequate treatment plan for these patients emerges, these findings may help lower readmission rates as well.

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Streptococcus gordonii is an early colonizer of the human oral cavity and an abundant constituent of oral biofilms. Two tandemly arranged gene clusters, designated lac and gal, were identified in the S. gordonii DL1 genome, which encode genes of the tagatose pathway (lacABCD) and sugar phosphotransferase system (PTS) enzyme II permeases. Genes encoding a predicted phospho-ß-galactosidase (LacG), a DeoR family transcriptional regulator (LacR), and a transcriptional antiterminator (LacT) were also present in the clusters. Growth and PTS assays supported that the permease designated EII(Lac) transports lactose and galactose, whereas EII(Gal) transports galactose. The expression of the gene for EII(Gal) was markedly upregulated in cells growing on galactose. Using promoter-cat fusions, a role for LacR in the regulation of the expressions of both gene clusters was demonstrated, and the gal cluster was also shown to be sensitive to repression by CcpA. The deletion of lacT caused an inability to grow on lactose, apparently because of its role in the regulation of the expression of the genes for EII(Lac), but had little effect on galactose utilization. S. gordonii maintained a selective advantage over Streptococcus mutans in a mixed-species competition assay, associated with its possession of a high-affinity galactose PTS, although S. mutans could persist better at low pHs. Collectively, these results support the concept that the galactose and lactose systems of S. gordonii are subject to complex regulation and that a high-affinity galactose PTS may be advantageous when S. gordonii is competing against the caries pathogen S. mutans in oral biofilms.

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Slow or insufficient enrollment in clinical research and a high demand for research participants raises questions about the need for and use of incentives to participate, including payment. Much of the available literature on payment to research participants focuses on ethical concerns, and rarely addresses guidelines, benchmarks, or formulas to assist investigators to assign or evaluate appropriate payment for individuals who take part in clinical research trials and procedures. Using four years of data collected about the inconvenience units assigned by intramural investigators to selected clinical research procedures conducted at the National Institutes of Health (NIH) Clinical Center, this study provides payment benchmarks for commonly performed procedures. Results were obtained from data collected on 36,273 incidents of payment made for procedures to research participants from August 2004 to August 2008. Analysis of the inconvenience units value assigned to specific procedures suggests that despite a wide distribution and frequent outliers, a convergence in practice around the center of distribution for most procedures does exist. As one of the first published studies reporting data reflecting payment amount for specific clinical research procedures, these data can guide investigators and institutional review boards as they establish and review an appropriate amount of payment to offer research participants. Our data may be useful in promoting payment standards for procedures, thereby complementing proposals or guidelines that advise payment calculations according to time and procedures.

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The purpose of this study was to evaluate the Night Eating Questionnaire (NEQ) as a measure of severity of the Night Eating Syndrome (NES). The 14-item NEQ assesses the behavioral and psychological symptoms of NES. The NEQ was evaluated in three samples: 1980 persons who completed the NEQ on the Internet; 81 persons diagnosed with NES; and 194 bariatric surgery candidates. Study 1, using principal components analysis, generated four factors (nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep) and an acceptable alpha (.70). Confirmatory factor analysis suggested that 99% of covariation among factors is accounted for by a higher-order construct. Study 2 found convergent validity of the NEQ with additional measures of night eating, disordered eating, sleep, mood, and stress. Study 3 compared scores from obese bariatric surgery candidates with and without NES and found appropriate discriminant validity of the NEQ. The NEQ appears to be an efficient, valid measure of severity for NES.

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OBJECTIVE: To test a novel method of facilitating pharmacotherapy at a distance and assess the effectiveness of sertraline for the treatment of night eating syndrome (NES). METHOD: The effectiveness of the selective serotonin reuptake inhibitor sertraline in the treatment of NES was assessed at a distance. NES is characterized by a delay in the circadian rhythm of food intake, with evening hyperphagia and/or nighttime awakenings and ingestions. Persons who contacted us through our Web site, e-mail, or telephone for help with their NES completed a Night Eating Questionnaire and received a semistructured interview (Night Eating Syndrome History and Inventory) to determine the presence of NES. Fifty such persons received treatment with sertraline from their own physicians, to whom we offered consultation. Participants completed questionnaires every 2 weeks for 8 weeks and received a final telephone interview to assess their progress. Outcomes were compared with those from an earlier face-to-face open-label trial of sertraline. The study was conducted from September 2003 to May 2005. RESULTS: Both the questionnaires and interviews showed improvements in 5 key aspects of NES: the general Night Eating Symptom Scale, evening hyperphagia, nighttime awakenings, nocturnal ingestions, and the Beck Depression Inventory (all p < .001), and the mean body weight of the 41 overweight and obese subjects, reported by survey, fell 3.0 kg (p = .01). These results are similar to those obtained in an earlier face-to-face trial of sertraline with NES. CONCLUSION: The study confirmed the effectiveness of sertraline in the treatment of NES and introduced a paradigm for facilitating pharmaco-therapy at a distance.

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STUDY OBJECTIVES: Evaluation of sleep in subjects with night eating syndrome (NES). DESIGN: Polysomnographic and questionnaire comparisons between subjects with NES and controls. SETTING AND PARTICIPANTS: Fifteen women with NES (mean +/- SD = 41 +/- 8 years) and 14 women (comparable age and weight) without NES (39 +/- 10 years) were studied in the laboratory for 3 days. INTERVENTIONS: N/A. MEASUREMENTS AND RESULTS: Subjects with NES did not differ from controls in timing of sleep onset or offset. They had less stage 2 sleep than controls (minutes, p = .012; percentage, p = .016) and less stage 3 sleep (p = .023), which contributed to their having a lower total sleep time (p = .05) and reduced sleep efficiency (p = .03). Subjects with NES did not have more awakenings than controls, but 93.3% of them ate on awakening during all 3 nights, while 92.9% of controls did not eat on any night. Logistic discriminant analyses identified a multiple sleep parameter model associated with increased likelihood of NES that had sensitivity of 84.6% and specificity of 76.9%. Patients with NES were more depressed than controls (p < .001) and reported greater sleep disturbance that included lower sleep quality (p < or = .001), reduced sleep duration (p < or = .001), and increased number of awakenings (p < or = .001). CONCLUSIONS: Patients with NES appear to have sleep maintenance insomnia rather than sleep-related eating disorder or a parasomnia. The maintenance of normal timing for sleep-wake behavior in the presence of a phase delay in the timing of caloric intake suggests this disorder reflects a state of internal circadian desynchrony associated with significant sleep complaints. It remains unknown whether the sleep disturbance precedes the abnormally timed eating.

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OBJECTIVE: The authors assessed the efficacy of sertraline in the treatment of night eating syndrome. METHOD: Thirty-four outpatients diagnosed with night eating syndrome were randomly assigned to receive either sertraline (N=17) or placebo (N=17) in an 8-week, double-blind, flexible-dose (50-200 mg/day) study. A mixed effects linear regression model was used to analyze change in the primary outcome measure, Clinical Global Impression (CGI) improvement rating. Secondary outcomes included changes in night eating symptoms, the number of nocturnal awakenings and ingestions, total daily caloric intake after the evening meal, CGI severity ratings, quality of life ratings, and weight. RESULTS: Sertraline was associated with significantly greater improvement than placebo. Twelve subjects in the sertraline group (71%) were classified as having responded (CGI improvement rating < or = 2, indicating much or very much improved) versus only three (18%) in the placebo group. There were also significant improvements in night eating symptoms, CGI severity ratings, quality of life ratings, frequency of nocturnal ingestions and awakenings, and caloric intake after the evening meal. Overweight and obese subjects in the sertraline group (N=14) lost a significant amount of weight by week 8 (mean=-2.9 kg, SD=3.8) compared with overweight and obese subjects receiving placebo (N=14) (mean=-0.3 kg, SD=2.7). CONCLUSIONS: In this 8-week trial, sertraline was effective in the treatment of night eating syndrome and was well tolerated.

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OBJECTIVE: This study assessed the prevalence of night eating syndrome and its comorbid psychopathology in a psychiatric population. METHOD: The Night Eating Questionnaire was administered to 399 patients in two psychiatric outpatient clinics. Those scoring above 20 on the questionnaire (N=205) were assessed for night eating syndrome with a semistructured telephone interview. Chart reviews of all participants were performed to determine their psychiatric diagnoses and medications. RESULTS: Forty-nine participants (12.3%) met criteria for night eating syndrome. Greater rates of substance use disorders were found among patients diagnosed with night eating syndrome than among those without the syndrome. Obese patients were more likely than nonobese patients to manifest night eating syndrome. CONCLUSIONS: Night eating syndrome is prevalent among psychiatric clinic outpatients and is likely to co-occur with substance use disorders and obesity.

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CONTEXT: Night eating syndrome (NES) is characterized by evening hyperphagia and frequent awakenings with ingestion of food. It is associated with obesity and depressed mood. Greater understanding of hormonal influences on NES is desirable. OBJECTIVE: Our objective was to evaluate 25-h profiles of hormones involved in energy balance, sleep, and stress in NES. DESIGN: Blood assays for glucose, insulin, ghrelin, leptin, melatonin, cortisol, TSH, and prolactin were sampled repeatedly among NES and control subjects. Food intake and depressive symptoms were assessed. SETTING AND PARTICIPANTS: Fifteen NES and 14 matched control participants stayed three nights in a General Clinical Research Center. MAIN OUTCOME MEASURES: We assessed differences between NES and control participants in the 25-h profiles of eight hormones. RESULTS: Nocturnal food intake was higher among NES participants, although their daily calorie intake was similar to that of controls. Reflecting their increased nocturnal intake, insulin (P < 0.001) and glucose levels (P = 0.07) among NES participants were higher than those of controls. Ghrelin levels were significantly lower in NES participants than in controls from 0100-0900 h (P = 0.003). Levels of plasma cortisol, melatonin, leptin, and prolactin did not differ between groups, but there was a trend for TSH levels (P = 0.07) to be higher during the 25 h in NES. NES participants had greater depressive symptoms than controls (P < 0.001). The differences in the levels of glucose, insulin, and ghrelin between NES and controls are closely associated with nocturnal food intake.

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OBJECTIVE: To compare the eating and sleep-wake patterns of persons with the night eating syndrome (NES) with those of matched control subjects. RESEARCH METHODS AND PROCEDURES: Forty-six overweight/obese NES subjects (mean age 43.3 +/- 9.8 years; 32 women) and 43 similar controls (mean age 39.0 +/- 11.0 years; 28 women) wore wrist actigraphs for 7 days and completed sleep and food diaries at home. RESULTS: There was no difference between the total energy intake of the NES and the control subjects, but the pattern of energy intake differed greatly. Relative to control subjects, the temporal pattern of food intake of night eaters was delayed. Food intake after the evening meal, as a proportion of the 24-hour intake, was more than 3-fold greater in NES subjects than in controls (34.6 +/- 10.1% vs. 10.0 +/- 6.9%, p = 0.001). NES subjects had sleep onset, offset, and total sleep duration times comparable with those of controls. NES subjects reported more nocturnal awakenings than did controls (1.5 +/- 1.0 per night vs. 0.5 +/- 0.5; p < 0.001), and their actigraphically monitored arousals occurred earlier during sleep (at 128 minutes after sleep onset vs. 193 minutes, p = 0.01). NES subjects consumed food on 74% of the awakenings vs. 0% for the controls. DISCUSSION: The pattern of cumulative energy intake of the night eaters suggests a phase delay in energy consumption relative to sleep-wake times. NES may involve a dissociation of the circadian control of eating relative to sleep.

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