Best Practices for Diagnostic Evaluation of Unintentional Weight Loss.

PD47-10 THE RESEARCH IMPLICATIONS OF PSA REGISTRY ERRORS

The safety of weight loss and low weight gain during pregnancy remains unclear. To determine how different patterns of gestational weight gain (GWG), including weight loss, stability, and low GWG relate to perinatal outcomes by prepregnancy obesity class. The study population included 29,408 singleton livebirths among pregnant people with obesity from Kaiser Permanente Northern California (2008-2013). Clinically measured GWG was grouped into meaningful categories (Adequate: reference, met 2009 National Academy of Medicine [NAM] Guidelines [5-9.1 kg], Excessive [>9.1 kg], Low [1-4.9 kg], Stable [±1 kg], Weight Loss [>1 kg]) or GWG Z-score quintiles. Modified Poisson regression was used to estimate risk of adverse outcomes, stratified by obesity class. Electronic health record data were used to define outcomes, including cesarean delivery, preterm birth, admission to the neonatal intensive care unit, small- and large-for-gestational age infants. Prevalence of weight stability and weight loss was 3.8 and 3.4%, respectively. Compared with those who gained within NAM, increased risk of small-for-gestational age was observed among those with weight loss among obesity class I (Risk Ratio (RR): 1.57, 95% confidence interval [CI]: 1.12, 2.19), obesity class II (RR: 2.18, 95% CI: 1.52, 3.13), and obesity class III (RR: 1.72, 95% CI: 1.21, 2.45). Weight loss was associated with a decreased risk of cesarean delivery among obesity class III, compared with NAM. Weight loss during pregnancy is associated with increased risk of small-for-gestational age among all obesity classes, but not other adverse perinatal outcomes and may reduce risk of cesarean delivery. Low weight gain and weight stability are not associated with risk of adverse outcomes among those with class III obesity. GWG guidelines may need to vary by obesity class. · Weight loss during pregnancy is associated with increased risk of small-for-gestational age among all obesity classes; but weight loss was not associated with other adverse perinatal outcomes.. · Among class III, low weight gain and weight stability are not associated with adverse perinatal outcomes.. · GWG guidelines may need to vary by obesity class..

Introduction: The CDC established the National Diabetes Prevention Program (NDPP) initiative in 2010, leading to implementation of numerous group-based lifestyle interventions, such as the 12-month Group Lifestyle Balance (GLB) program, in community and clinical settings. Heterogeneity in weight outcomes is common. While evidence suggests that session attendance is associated with greater weight loss, some participants do not achieve weight loss even with high session attendance. Conversely, some may achieve clinically significant weight loss (≥5%) with lower attendance. In this study, we sought to identify and characterize such paradoxical interventional outcomes. (i.e., high session attendance and <5% weight loss compared with low attendance and ≥5% weight loss). Hypothesis: No a priori hypotheses. Methods: We conducted a longitudinal descriptive analysis of overweight/obese GLB participants using electronic health record data from an integrated healthcare delivery system in Northern California (2010-2017). We focused on the 12-week intensive core phase of the curriculum because prior studies show that weight loss outcomes achieved during this period are highly correlated with long-term weight loss. We categorized patients into 4 mutually exclusive groups by session attendance (<9/≥9 session) and weight change from baseline to 12-weeks follow-up (<5%/≥5% weight loss). The threshold of 9 sessions corresponds to 75% adherence, a quality metric used by Medicare. Results: Among 1,818 evaluable participants, we identified 870 (47.9%) with paradoxical outcomes. Of these, 104 (12.0%) achieved ≥5% weight loss with <9 sessions attended (paradoxical responders) and 766 (88.0%) achieved <5% weight loss despite attending ≥9 sessions (paradoxical non-responders). The remaining 948 participants (52.1%) achieved weight loss consistent with a dose response, based on number of sessions attended. Conclusions: Nearly half of all GLB participants in this integrated health system had paradoxical outcomes, with more than 40% classified as paradoxical non-responders. These results suggest that session attendance may not be as sensitive a predictor of weight outcomes as previously thought, and other approaches are needed to understand the complex factors influencing goal attainment in behavioral lifestyle programs.

CANA and GLP-1s have demonstrated weight loss (WL) in patients with type 2 diabetes mellitus (T2DM) in clinical trials. We compared the effects of CANA vs. GLP-1s on BW outcomes in routine practice using claims and electronic health record data from the U.S. Optum integrated database for adults with T2DM and ≥1 prescription claim for CANA or any GLP-1 from 1/1/13-3/31/15. BW outcomes and achievement of clinically significant WL ≥5% were assessed in matched patients with both ≥1 BW measurement during baseline (BL) and >31 days post-index. Inverse probability of treatment weighting (IPTW) accounted for differences in BL covariates. Weighted Cox regression was used to examine the hazard ratio (HR) and 95% confidence interval (CI) of WL ≥5%. After IPTW, covariates were balanced between cohorts except for BL BMI (CANA: n = 213; GLP-1: n = 235). Significant differences in BW were seen in the CANA vs. GLP-1 cohort over 9 months of follow-up (Figure). CANA cohort patients were more likely to achieve WL ≥5% (HR 1.93; 95% CI: 1.40-2.66) with a significantly longer duration at WL ≥5% (133 vs. 103 days; P = 0.01) than GLP-1 cohort patients. In summary, superior WL of >9 kg at 9 months, >17% more patients achieving WL ≥5%, and longer duration of WL ≥5% as seen in the CANA vs. GLP-1 cohort may have important clinical implications due to links between BW reduction and other clinical/economic outcomes. Disclosure C.I. Coleman: Research Support; Self; Janssen Pharmaceuticals, Inc., Boehringer Ingelheim Pharmaceuticals, Inc. W.H. Herman: Other Relationship; Self; Merck Sharp & Dohme Corp., Lexicon Pharmaceuticals, Inc.. Consultant; Self; Janssen Scientific Affairs, LLC.. Research Support; Spouse/Partner; Nestlé. Other Relationship; Self; American Diabetes Association. Advisory Panel; Self; National Committee for Quality Assurance (NCQA). S. Pandya: Other Relationship; Self; Janssen Scientific Affairs, LLC. L. Wang: Other Relationship; Self; Janssen Scientific Affairs, LLC.. O. Baser: None. J. Cai: Employee; Self; Janssen Scientific Affairs, LLC. B. Bookhart: Employee; Self; Janssen Scientific Affairs, LLC..

Association of Clinician Behaviors and Weight Change in School-Aged Children

BackgroundGeriatric syndromes, including frailty, are common in older adults and associated with adverse outcomes. We compared patients described in clinical notes as “frail” to other older adults with respect to geriatric syndrome burden and healthcare utilization.MethodsWe conducted a retrospective cohort study on 18,341 Medicare Advantage enrollees aged 65+ (members of a large nonprofit medical group in Massachusetts), analyzing up to three years of administrative claims and structured and unstructured electronic health record (EHR) data. We determined the presence of ten geriatric syndromes (falls, malnutrition, dementia, severe urinary control issues, absence of fecal control, visual impairment, walking difficulty, pressure ulcers, lack of social support, and weight loss) from claims and EHR data, and the presence of frailty descriptions in clinical notes with a pattern-matching natural language processing (NLP) algorithm.ResultsOf the 18,341 patients, we found that 2202 (12%) were described as “frail” in clinical notes. “Frail” patients were older (82.3 ± 6.8 vs 75.9 ± 5.9, p < .001) and had higher rates of healthcare utilization, including number of inpatient hospitalizations and emergency department visits, than the rest of the population (p < .001). “Frail” patients had on average 4.85 ± 1.72 of the ten geriatric syndromes studied, while non-frail patients had 2.35 ± 1.71 (p = .013). Falls, walking difficulty, malnutrition, weight loss, lack of social support and dementia were more highly correlated with frailty descriptions. The most common geriatric syndrome pattern among “frail” patients was a combination of walking difficulty, lack of social support, falls, and weight loss.ConclusionsPatients identified as “frail” by providers in clinical notes have higher rates of healthcare utilization and more geriatric syndromes than other patients. Certain geriatric syndromes were more highly correlated with descriptions of frailty than others.

16531 Background: Concomitant Chemoradiotherapy (CRT) is a standard treatment modality for locally advanced squamous cell head and neck cancer (HNC). This treament is often associated with significant weight loss which is commonly attributed to nutritional depletion secondary to mucositis, pain and inadequate oral intake. We undertook an evaluation of thyroid function as measured by Thyroid Stimulating Hormone (TSH) levels during CRT to evaluate the possible role of a thyroid hormone flare during treatment that may account for part of this weight loss. Methods: Institutional Review Board approval was obtained to conduct this retrospective analyses. Patients treated at our institution during the past six months who were treated with CRT for HNC and had recorded TSH levels at baseline (when available), mid treatment (week 4 to 6 of CRT), and post CRT (6 to 9 weeks later), at least 5% weight loss during treatment, and feeding tube requirement data available were identified. Age, Gender, Stage and Primary site of disease, Radiation dose and fields, chemotherapy regimen, were recorded. Results: Twelve patients were identified. Mid treatment TSH levels were suppressed below normal reference range (0.49–4.67 mIU/L) in 7of 12 pts (58%). A decline in TSH levels was noted in all 8 of 8 pts (100%) that had recorded pre-CRT TSH levels and mid treatment levels. Improvement of TSH levels was noted in all 9 of 9 patients that had mid treatment and post treatment TSH levels recorded, although in three of these nine patients TSH levels remained below normal range. Four of twelve pts required PEG placements for nutritional support. Conclusions: Transient suppression of TSH levels suggesting a thyroid flare is frequently observed early during CRT for HNC and appears to improve by 6–9 weeks post treatment. This may contribute to weight loss in this nutritionally challanged population. Further studies evaluating more specialised thyroid function testing to exclude sick euthyroid states and other etiologies for suppressed TSH levels are warranted. In addtion, therapeutic methods to abbrogate this flare may reduce weight loss during aggressive CRT treatment protocols. No significant financial relationships to disclose.

Gastric Adenocarcinoma in patients with Roux-en-Y Gastric bypass: A case series

Managed care organizations put great effort into managing the population of patients with type 2 diabetes mellitus (T2DM) because of the health and economic burden of this disease. In patients with T2DM, weight loss and glycemic control are primary treatment aims to help improve patient outcomes, but these goals are not easily achieved. While achieving these aims requires a multifaceted approach of drug therapy management and lifestyle modification, truly understanding the role of medication adherence in achieving these outcomes is important for both patient and population management. This study expands on existing evidence that weight loss is associated with improved glycemic control by examining the role of medication adherence in achieving these goals in a managed care setting. This study is unique in that these associations are evaluated using multiple sources of data, including medical records for treatment outcomes, pharmacy claims, and patient-reported data to assess medication adherence. These data sources represent those typically available to payers or providers. To describe the relationships between medication and adherence, weight change, and glycemic control in patients with T2DM. This historical cohort study included adult patients with T2DM in a large integrated health system and was based on electronic health record and pharmacy claims data from November 1, 2010, through October 31, 2011, as well as data from a self-reported adherence survey conducted in March 2012. Included patients received a diabetes medication from a therapeutic class not previously received, between November 1, 2010, and April 30, 2011 (index date), who had blood glucose (HbA1c) and weight values at index date and 6 months follow-up, participated in an adherence survey, and had ≥ 1 prescription claim for the index-date drug. Associations between the dual outcomes of weight loss (≥ 3%) and HbA1c control ( less than 7.0%), while controlling for medication adherence and other demographic, treatment, and clinical variables, were evaluated using structural equation models (SEM). Separate models adjusted for different measures of medication adherence-self-reported using the 5-item Medication Adherence Rating Scale (MARS-5) and a modified medication possession ratio (mMPR) from pharmacy claims data. The study included 166 patients with a mean age of 61.1 (standard deviation = 12.1) years; 56.0% were female. Medication adherence was high, with 72.2% adherent using MARS-5 and 77.1% using mMPR measures. The SEMs found that only self-reported medication adherence is associated with weight loss (MARS-5: OR = 1.70, 95% CI = 1.11-2.60), while both self-reported and claims-based medication adherence were associated with HbA1c less than 7.0% (MARS-5: OR = 1.59, 95% CI = 1.09-2.34; mMPR: OR 2.71, 95% CI = 1.22-5.98). Further, weight loss is significantly associated with HbA1c less than 7.0% (MARS-5: OR = 3.60, 95% CI = 2.39-5.46; mMPR: OR 2.99, 95% CI = 1.45-6.17). This study has provided additional evidence in a managed, integrated setting that in patients treated for T2DM, weight loss is associated with good glycemic control. Adherence is associated with weight loss according to self-report, but not claims-based adherence measures. Adherence is also associated with glycemic control as measured by the 2 different methods. This study adds to the body of literature highlighting the importance of adherence as well as weight loss in achieving good glycemic control. The fact that the association of weight loss and adherence on glycemic control outcomes was significant regardless of medication adherence method is important in payer-provider collaborations, where access to data sources to evaluate adherence may vary. This study also supports continued investment in weight loss and adherence programs in the management of patients with T2DM.

Prostate-Specific Antigen: A Misused and Maligned Prostate Cancer Biomarker

The utility of electronic health record data for identifying postpartum hemorrhage

Public health surveillance systems for acute hepatitis are limited: clinician reporting is insensitive and electronic laboratory reporting is nonspecific. Insurance claims and electronic health records are potential alternative sources. To compare the utility of laboratory data, diagnosis codes, and electronic health record combination data (current and prior viral hepatitis studies, liver function tests, and diagnosis codes) for acute hepatitis A and B surveillance. Retrospective chart review. Massachusetts ambulatory practice serving 350 000 patients per year. All patients seen between 1990 and 2008. Sensitivity and positive predictive value of immunoglobulin M (IgM), International Classification of Disease-Ninth Revision (ICD-9) diagnosis codes, and combination electronic health record data for acute hepatitis A and B. During the study period, there were 111 patients with positive hepatitis A IgMs, 154 with acute hepatitis A ICD-9 codes, and 77 with positive IgM and elevated liver function tests. On review, 79 cases were confirmed. Sensitivity and positive predictive value were 100% and 71% (95% confidence interval, 62%-79%) for IgM, 94% (92%-100%) and 48% (40%-56%) for ICD-9 codes and 97% (92%-100%) and 100% (96%-100%) for combination electronic health record data. There were 14 patients with positive hepatitis B core IgMs, 2564 with acute hepatitis B ICD-9 codes, and 125 with suggestive combinations of electronic health record data. Acute hepatitis B was confirmed in 122 patients. Sensitivity and positive predictive value were 9.4% (5.2%-16%) and 86% (60%-98%) for hepatitis B core IgM, 73% (65%-80%) and 3.6% (2.9%-4.4%) for ICD-9 codes, and 96% (91%-99%) and 98% (94%-99%) for electronic health record data. Laboratory surveillance using IgM tests overestimates the burden of acute hepatitis A and underestimates the burden of acute hepatitis B. Claims data are subject to many false positives. Electronic health record data are both sensitive and predictive. Electronic health record-based surveillance systems merit development.

The BARI-hoods Project: neighborhood social determinants of health and postoperative weight loss using integrated electronic health record, census, and county data.

Assessing generalizability of clinical trials is important to ensure appropriate application of interventions, but most assessments provide minimal granularity on comparisons of clinical characteristics. To assess the extent of underlying clinical differences between clinical trial participants and nonparticipants by using a combination of electronic health record and trial enrollment data. This cross-sectional study used data obtained from a single academic medical center between September 1996 and January 2019 to identify 1645 clinical trial participants from a diverse set of 202 available trials conducted at the center. Using an aggregated resampling procedure, nonparticipants were matched to participants 1:1 based on trial conditions, number of recent visits to a health care professional, and calendar time. Clinical trial enrollment vs no enrollment. The primary outcome was standardized differences in clinical characteristics between participants and nonparticipants in clinical trials stratified into the 4 most common disease domains. This cross-sectional study included 1645 participants from 202 trials (929 [56.5%] male; mean [SD] age, 54.65 [21.38] years) and an aggregated set of 1645 nonparticipants (855 [52.0%] male; mean [SD] age, 57.24 [21.91] years). The most common disease domains for the selected trials were neoplastic disease (86 trials; 737 participants), disorders of the digestive system (31 trials; 321 participants), inflammatory disorders (28 trials; 276 participants), and disorders of the cardiovascular system (27 trials; 319 participants); trials could qualify for multiple disease domains. Among 31 conditions, the percentage of conditions for which the prevalence was lower among participants than among nonparticipants per standardized differences was 64.5% (20 conditions) for neoplastic disease trials, 61.3% (19) for digestive system trials, 58.1% (18) for inflammatory disorder trials, and 38.7% (12) for cardiovascular system trials. Among 17 medications, the percentage of medications for which use was less among participants than among nonparticipants per standardized differences was 64.7% (11) for neoplastic disease trials, 58.8% (10) for digestive system trials, 88.2% (15) for inflammatory disorder trials, and 52.9% (9) for cardiovascular system trials. Using a combination of electronic health record and trial enrollment data, this study found that clinical trial participants had fewer comorbidities and less use of medication than nonparticipants across a variety of disease domains. Combining trial enrollment data with electronic health record data may be useful for better understanding of the generalizability of trial results.

Introduction: Recent experiments and clinical studies indicate the contribution of thyroid hormones to prostate pathology. Aim: In our retrospective analyzis of university patient population, we evaluated the association between thyroid stimulatory hormone (TSH) and prostate specific antigen (PSA). Method: From the Laboratory Information System we retrieved the data of male patients between 40 and 75 years of age who had been subjected to simultaneous TSH and PSA measurements during the last 12 years (n = 7279). The association between logTSH and logPSA levels was tested with multiple regression analysis and adjusted for age. Results: Significant associations between logPSA and logTSH and age (r = 0.297 and 0.472, respectively) were detected. PSA levels were higher in patients with TSH below (n = 405) than in those with TSH within reference range (TSH 0,35-4,95 mU/ml) (n = 6698) (PSA level: 1.118 [0.639-2.338] vs. 0.920 [0.508-1.826] ng/ml, p<0.016). Based on estimates, a 10% decrease in TSH is associated with a 0.42% increase in PSA levels in our population. This corresponds to a 42% increase in PSA levels in the same patient if he would present with 0.2 mU/ml instead of 2.0 mU/ml TSH. Conclusion: The finding that hyperthyreosis might be associated with higher PSA levels indicates that PSA reference ranges would differ in hyperthyreotic and in euthyreotic patients. Probably the PSA clinical decision limits is also recommended to be modified according to the patient's thyroid status. Orv Hetil. 2019; 160(35): 1376-1379.