How does sleeve gastrectomy impact long-term eating-related symptoms, distress, and behavior? A cross-sectional study using the BODY-Q patient-reported outcome measures.

BACKGROUND: Patients undergoing sleeve gastrectomy (SG) experience transformative changes in eating-related experiences that include eating-related symptoms, emotions, and habits. Long-term assessment of these endpoints with rigorous patient-reported outcome measures (PROMs) is limited. We assessed patients undergoing SG with the Body-Q Eating Module PROMs. METHODS: All patients evaluated at the Emory Bariatric Center were given the Body-Q Eating Modules questionnaire at preoperative/postoperative clinic visits. Rasch scores and prevalence of relevant endpoints were assessed across six time-points of interest: preoperatively, post-operative months 0-6, 7-12, 12-24, 24-36, and over 36. Student's t-test and Chi-square test were used for analysis. RESULTS: Overall, 1,352 questionnaires were completed pre-operatively and 493 postoperatively. Survey compliance was 81%. Compared to the pre-operative group, the post-operative group had lower BMI (39.7 vs. 46.4, p < 0.001) and higher age (46.3 vs. 44.9, p = 0.019). Beginning one year after SG, patients experience more frequent eating-related pain, nausea and constipation compared to pre-operative baseline (p < 0.05). They also more frequently experience eating-related regurgitation and dumping syndrome-related symptoms beginning post-operative year two (p < 0.05). In the first year after SG, patients more rarely feel eating-related embarrassment, guilt, and disappointment compared to pre-operative baseline (p < 0.05). These improvements disappear one year after SG, after which patients more frequently experience feeling out of control, unhappy, like a failure, disappointed, and guilty (p < 0.05). In the first year after SG, patients experience an increased frequency in positive eating behaviors (ate healthy foods, showed self-control, stopped before full; (p < 0.05). Only two eating-related behavior improvements persist long-term: feeling in control and eating the right amount (p < 0.05). CONCLUSIONS: Patients undergoing SG may experience more frequent eating-related symptoms, distress, and behavior in the long-term. These findings can enhance the pre-operative informed consent and guide development of a more tailored approach to postoperative clinical management such as more frequent visits with the dietician.

Does the use of a suction calibration system (SCS) reduce stapler load firings and operative time? A randomized controlled trial comparing use of endoscopic calibration vs. SCS in laparoscopic sleeve gastrectomy.

BACKGROUND: It is critical to ensure appropriate and consistent sleeve size and orientation during laparoscopic sleeve gastrectomy (LSG). Various devices are used to achieve this, including weighted rubber bougies, esophagogastroduodenoscopy (EGD), and suction calibration systems (SCS). Prior reports suggest that SCSs may decrease operative time and stapler load firings but are limited by single-surgeon experience and retrospective design. We performed the first randomized controlled trial comparing SCS against EGD in patients undergoing LSG to investigate whether the SCS decreases the number of stapler load firings. METHODS: This was a randomized, non-blinded study from a single MBSAQIP-accredited academic center. Appropriate LSG candidates ≥ 18 years of age were randomized to EGD or SCS calibration. Exclusion criteria included prior gastric or bariatric surgery, detection of hiatal hernia before surgery, and intraoperative hiatal hernia repair. A randomized block design was employed controlling for body mass index, gender, and race. Seven surgeons employed a standardized LSG operative technique. The primary endpoint was the number of stapler load firings. Secondary endpoints were operative duration, reflux symptoms, and change in total body weight (TBW). Endpoints were analyzed via t-test. RESULTS: A total of 125 LSG patients (84% female) underwent study enrollment, with an average age of 44 ± 12 years and average BMI of 49 ± 8 kg/m2. Overall, 117 patients were randomized to receive EGD (n = 59) or SCS (n = 58) calibration. No significant differences in baseline characteristics were identified. The mean number of stapler load firings for EGD and SCS groups were 5.43 ± 0.89 and 5.31 ± 0.81, respectively (p = 0.463). The mean operative times for EGD and SCS groups were 94.4 ± 36.5 and 93.1 ± 27.9 min, respectively (p = 0.83). There were no significant differences in post-operative reflux, TBW loss, or complications. CONCLUSION: Use of EGD and SCS resulted in a similar number of LSG stapler load firings and operative duration. Additional research is needed to compare LSG calibration devices in different patients and settings to optimize surgical technique.

The financial impact of the COVID-19 pandemic on sleeve gastrectomy at a major academic institution.

INTRODUCTION: The COVID-19- pandemic significantly impacted metabolic and bariatric surgery (MBS) practices due to large-scale surgery cancellations along with staff and supply shortages. We analyzed sleeve gastrectomy (SG) hospital-level financial metrics before and after the COVID-19 pandemic. METHODS: Hospital cost-accounting software (MicroStrategy, Tysons, VA) was reviewed for revenues, costs, and profits per SG at an academic hospital (2017-2022). Actual figures were obtained, not insurance charge estimates or hospital projections. Fixed costs were obtained through surgery-specific allocation of inpatient hospital and operating-room costs. Direct variable costs were analyzed with sub-components including: (1) labor and benefits, (2) implants, (3) drug costs, and 4) medical/surgical supplies. The pre-COVID-19 period (10/2017-2/2020) and post-COVID-19 period (5/2020-9/2022) financial metrics were compared with student's t-test. Data from 3/2020 to 4/2020 were excluded due to COVID-19-related changes. RESULTS: A total of 739 SG patients were included. Average length of stay (LOS), Center for Medicaid and Medicare Case Mix Index (CMI), and percentage of patients with commercial insurance were similar pre vs. post-COVID-19 (p > 0.05). There were more SG performed per quarter pre-COVID-19 than post-COVID-19 (36 vs. 22; p = 0.0056). Pre-COVID-19 and post-COVID-19 financial metrics per SG differed significantly for, respectively, revenues ($19,134 vs. $20,983) total variable cost ($9457 vs. $11,235), total fixed cost ($2036 vs. $4018), total profit ($7571 vs. $5442), and labor and benefits cost ($2535 vs. $3734; p < 0.05). CONCLUSIONS: The post-COVID-19 period was characterized by significantly increased SG fixed cost (i.e., building maintenance, equipment, overhead) and labor costs (increased contract labor), resulting in precipitous profit decline that crosses the break-even in calendar year quarter (CQ) 3, 2022. Potential solutions include minimizing contract labor cost and decreasing LOS.

How to make PROMs work: qualitative insights from leaders at United States hospitals with successful PROMs programs.

PURPOSE: Elucidate facilitators, barriers, and key lessons learned regarding the implementation of system-wide clinical patient-reported outcome measure (PROM) programs among United States (US) healthcare leaders. METHODS: We conducted semi-structured interviews with 35 US healthcare leaders, including chief-level executives, data directors, PROM directors, and department chairs involved in PROM implementation across seven diverse healthcare systems from February to June 2020. Transcripts were coded, evaluated for qualitative themes, and categorized according to the consolidated framework for implementation research (CFIR). RESULTS: According to US hospital leaders with experience in existing clinical PROM programs, there are facilitators and barriers to implementation success in each CFIR domain. Allowing clinicians to select PROM measures and ensuring a user-friendly data platform (intervention); adapting data collection to patient home environments (outer setting); informing clinicians of the multi-faceted use of PROM data for research, clinical care, and business (inner setting); implementing PROM education earlier into clinician training (characteristics of individuals); and establishing specialty-agnostic PROM implementation teams (process) were among key facilitators to implementation success. CONCLUSION: Leaders of geographically and clinically diverse PROM programs in the US identify common themes that facilitate successful implementation. Drivers of success depend on factors within and outside the clinical environment. These findings may serve to guide both establishing new PROM programs and refining existing PROM programs.

The Surgeon's Perceived Value of Patient-reported Outcome Measures (PROMs): An Exploratory Qualitative Study of 5 Different Surgical Subspecialties.

OBJECTIVE: To understand the surgeon's perceived value of PROMs in 5 different surgical subspecialties. SUMMARY OF BACKGROUND DATA: PROMs are validated questionnaires that assess the symptoms, function, and quality of life from the patient's perspective. Despite the increasing support for use of PROMs in the literature, there is limited uptake amongst surgeons. Furthermore, there is insufficient understanding of the surgeons' perceived value of PROMs. The aim of this study is to understand how surgeons perceive value in PROMs. METHODS: We conducted an exploratory qualitative study to understand the perceived value of PROMs from the perspective of surgeons in various subspecialties. Per convenience sampling, we conducted semi-structured interviews with 30 surgeons from 5 subspecialties across 3 academic medical centers. The surgical subspecialties included bariatric surgery, breast oncologic surgery, orthopedic surgery, plastic and reconstructive surgery, and rhinology. Interviews were transcribed, coded, and evaluated with thematic analysis. RESULTS: Surgeons endorsed that PROMs can be used to enhance clinical management, counsel patients in the preoperative and postoperative settings, and elicit sensitive information from patients that otherwise may go undetected. Obstacles to PROMs use include failure to generate actionable data, implementation obstacles, and inappropriate use of PROMs as a performance metric, with concerns regarding inadequate risk adjustment. CONCLUSIONS: Establishing an effective PROMs program requires an understanding of the surgeon's perspective of PROMs. Despite obstacles, different subspecialty surgeons find PROMs to be valuable in different settings, depending on the specialty and clinical context.

BODY-Q patient-reported outcomes measure (PROM) to assess sleeve gastrectomy vs. Roux-en-Y gastric bypass: eating behavior, eating-related distress, and eating-related symptoms.

BACKGROUND: Post-operative changes in eating behavior, eating-related distress and eating-related symptoms play an important role in the lives of bariatric surgery patients. However, there are no studies that assess these outcomes using a specifically designed patient-reported outcome measure (PROM) for patients undergoing bariatric surgery. We use our newly developed and validated scales as part of the well-established BODY-Q PROMs to compare laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass patients (LRYGB). METHODS: We analyzed data from an international multi-center prospective cohort study of patients over 18 who underwent bariatric surgery. We used multivariable linear regression models to assess the difference between LRYGB and LSG for the new BODY-Q scales, which include eating behavior, eating-related distress and eating-related symptoms. All analyses were corrected for significant confounding variables. RESULTS: Out of 1420 patients, 920 underwent LRYGB and 500 underwent LSG. The LRYGB group had a higher percentage total weight loss (p < 0.001). There was no significant difference in eating behavior (e.g., stop eating before feeling full, avoiding unhealthy snacks, etc.) or eating-related distress (e.g., feeling ashamed or out of control after eating). Patients who underwent LSG scored significantly better on the post-prandial eating-related symptoms scale (e.g., vomiting, reflux; p < 0.001). Symptoms more prevalent in the LRYGB patients were related to dumping syndrome whereas symptoms more prevalent in LSG patients were related to reflux. CONCLUSION: Patients who underwent LRYGB had a significantly better weight loss after surgery, but they scored worse on post-prandial symptoms in comparison to LSG patients. This information may be relevant for patients in the pre-operative counseling setting, as it may influence their decision for surgical procedure selection.

Viral-induced CD28 loss evokes costimulation independent alloimmunity.

BACKGROUND: Belatacept, a B7-specific fusion protein, blocks CD28-B7 costimulation and prevents kidney allograft rejection. However, it is ineffective in a sizable minority of patients. Although T-cell receptor and CD28 engagement are known to initiate T-cell activation, many human antigen-experienced T-cells lose CD28, and can be activated independent of CD28 signals. We posit that these cells are central drivers of costimulation blockade resistant rejection (CoBRR) and propose that CoBRR might relate to an accumulation of CD28(-) T-cells resulting from viral antigen exposure. MATERIALS AND METHODS: We infected C57BL/6 mice with polyomavirus (a BK virus analog), murine cytomegalovirus (a human cytomegalovirus analog), and gammaherpesvirus (HV68; an Epstein-Barr virus analog) and assessed for CD28 expression relative to mock infection controls. We then used mixed lymphocyte reaction (MLR) assays to assess the alloreactive response of these mice against major histocompatibility complex-mismatched cells. RESULTS: We demonstrated that infection with polyomavirus, murine CMV, and HV68 can induce CD28 downregulation in mice. We showed that these analogs of clinically relevant human viruses enable lymphocytes from infected mice to launch an anamnestic, costimulation blockade resistant, alloreactive response against major histocompatibility complex-mismatched cells without prior alloantigen exposure. Further analysis revealed that gammherpesvirus-induced oligoclonal T-cell expansion is required for the increased alloreactivity. CONCLUSIONS: Virus exposure results in reduced T-cell expression of CD28, the target of costimulation blockade therapy. These viruses also contribute to increased alloreactivity. Thus, CD28 downregulation after viral infection may play a seminal role in driving CoBRR.

Achieving durable compliance with venous thromboembolism prophylaxis in bariatric surgery: 3-year data from a major academic medical center.

BACKGROUND: Metabolic and bariatric surgery (MBS) venous thromboembolism (VTE) prescribing practices vary widely. Our institutional VTE prophylaxis protocol has historically been unstandardized. OBJECTIVES: To create a standardized MBS VTE prophylaxis protocol, track protocol compliance, and identify barriers to protocol compliance and address them with Plan-Do-Study-Act (PDSA) cycles. SETTING: Single Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program-accredited academic hospital. METHODS: We conducted a retrospective study for all patients undergoing MBS (January 2019 to September 2022). A multidisciplinary group of bariatric clinicians reviewed literature and developed the following standardized VTE prophylaxis protocol: 5000 units preoperative subcutaneous (SC) heparin within 60 minutes of anesthesia induction and postoperative 40 mg SC low molecular weight heparin (LMWH) within 24 hours of surgery. This protocol was distributed to relevant clinical stakeholders. We assessed monthly compliance rates through chart review. Goal compliance was ≥90%. We identified sources of noncompliance and addressed them with PDSA methodology. RESULTS: A total of 796 patients were included. Preoperative heparin administration increased from a mean of 47% (107/228) preintervention to 96% (545/568) postintervention (P < .0001), and postoperative LMWH administration increased from 71% (47/66) to 96% (573/597, P = .0002). These compliance rates were sustained for 3 years. Barriers to protocol noncompliance included order set timing errors (n = 45), surgeon error (n = 44), surgeon discretion (n = 40), and nursing error (n = 20). No change in bleeding or VTE rates was observed. CONCLUSIONS: Developing a standardized VTE prophylaxis protocol, monitoring process measures, and engaging relevant stakeholders in PDSA cycles resulted in drastic and durable improvement in VTE prophylaxis compliance rates.

Quantifying patients' expectations prior to bariatric surgery with the BODY-Q in an international multicentre cohort.

Many people living with obesity may have unrealistic expectations prior to undergoing bariatric surgery. These expectations can lead to frustration, regret and even worse psychological outcomes after surgery. Prior to undergoing bariatric surgery, patients completed the BODY-Q Expectations scale. This 15-item scale asks patients to imagine what their life will be like when 2 years have passed since bariatric surgery. Scores for expectations range from 0 (low) to 100 (high). Linear regression models were used to assess which of the patient characteristics could predict patients' expectations. From 2019 to 2020, a total of 333 patients were recruited from three different countries. The mean score on the BODY-Q Expectations scale was 73.1, ±20. Out of the 15 items on the Expectation scale, people living with obesity found it most likely that bariatric surgery would make them feel better and improve their energy, while it was reported least likely that they would look good without clothes on. Younger age (p = <.01) and race (non-white) (p = .046) were found to be significant predictors for higher scores on the Expectations scale. Participants who identified as non-white from the Netherlands and United States, and those aged under 40 years reported higher expectations compared with participants who identified as white race and were 40 years of age or older. Prior to bariatric surgery, patients aged under 40 years and those who identified as non-white for race had higher expectations that their life would change after bariatric surgery. These relevant findings should be considered when giving pre-operative counselling.

BODY-Q Normative Scores: Psychometric Validation of the BODY-Q in the General Population in Europe and North America.

Background: BODY-Q is a rigorously developed patient-reported outcome measure designed to measure outcomes of weight loss and body contouring patients. To allow interpretation and comparison of BODY-Q scores across studies, normative BODY-Q values were generated from the general population. The aim of this study was to examine the psychometric properties of BODY-Q in the normative population. Methods: Data were collected using two crowdsourcing platforms (Prolific and Amazon Mechanical Turk) in 12 European and North American countries. Rasch measurement theory (RMT) was used to examine reliability and validity of BODY-Q scales. Results: RMT analysis supported the psychometric properties of BODY-Q in the normative sample with ordered thresholds in all items and nonsignificant chi-square values for 167 of 176 items. Reliability was high with person separation index of greater than or equal to 0.70 in 20 of 22 scales and Cronbach alpha values of greater than or equal to 0.90 in 17 of 22 scales. Mean scale scores measuring appearance, health-related quality of life, and eating-related concerns scales varied as predicted across subgroups with higher scores reported by participants who were more satisfied with their weight. Analysis to explore differential item functioning by sample (normative versus field-test) flagged some potential issues, but subsequent comparison of adjusted and unadjusted person estimates provided evidence that the scoring algorithm worked equivalently for the normative sample as in the field-test samples. Conclusions: The BODY-Q scales showed acceptable reliability and validity in the normative sample. The normative values can be used as reference in research and clinical practice in combination with local estimates for parallel analysis and comparison.

Impetus of US hospital leaders to invest in patient-reported outcome measures (PROMs): a qualitative study.

OBJECTIVES: Though hospital leaders across the USA have invested significant resources in collection of patient-reported outcome measures (PROMs), there are very limited data on the impetus for hospital leadership to establish PROM programmes. In this qualitative study, we identify the drivers and motivators of PROM collection among hospital leaders in the USA. DESIGN: Exploratory qualitative study. SETTING: Thirty-seven hospital leaders representing seven different institutions with successful PROMs programs across twenty US states. METHODS: Semistructured interviews conducted with hospital leaders. Transcripts were analysed using thematic analysis. RESULTS: Leaders strongly believe that collecting PROMs is the 'right thing to do' and that the culture of the institution plays an important role in enabling PROMs. The study participants often believe that their institutions deliver superior care and that PROMs can be used to demonstrate the value of their services to payors and patients. Direct financial incentives are relatively weak motivators for collection of PROMs. Most hospital leaders have reservations about using PROMs in their current state as a meaningful performance metric. CONCLUSION: These findings suggest that hospital leaders feel a strong moral imperative to collect PROMs, which is also supported by the culture of their institution. Although PROMs are used in negotiations with payors, direct financial return on investment is not a strong driver for the collection of PROMs. Understanding why leaders of major healthcare institutions invest in PROMs is critical to understanding the role that PROMs play in the US healthcare system.

General population normative scores for interpreting the BODY-Q.

The BODY-Q is a patient-reported outcome measure used to assess outcomes in patients undergoing weight loss and/or body contouring surgery (BC) following massive weight loss. Normative values for the BODY-Q are needed to improve data interpretation and enable comparison. Thus, the aim of this study was to determine normative values for the BODY-Q. Participants were recruited internationally through two crowdsourcing platforms. The participants were invited to complete the BODY-Q scales through an URL link provided within the crowdsourcing platforms. General linear analyses were performed to compare normative means between countries and continents adjusted for relevant covariates. Normative reference values were stratified by age, body mass index (BMI), and gender. The BODY-Q was completed by 4051 (2052 North American and 1999 European) participants. The mean age was 36 years (±14.7 SD) and ranged from 17 to 76 years, the mean BMI was 26.4 (±6.7 SD) kg/m2 , and the sample consisted of 1996 (49.3%) females and 2023 (49.9%) males. Younger age and higher BMI were negatively associated with all BODY-Q scales (p < .001). This study provides normative values for the BODY-Q scales to aid in the interpretation of BODY-Q scores in research and clinical practise. These values enable us to understand the impact of weight loss and BC on patients' lives.

The impact of body mass index (BMI) on satisfaction with work life: An international BODY-Q study.

Obesity is a global health issue known to have a major influence on health-related quality of life (HR-QOL). HR-QOL is a concept evaluating physical and psychological health. Work life can impact HR-QOL in people with obesity. The aim of this study was to measure the association between body mass index (BMI) and satisfaction with work life. This study included participants from an international multicenter field-test study of BODY-Q scales. Recruitment took place at hospitals in Denmark, The Netherlands and USA between June 2019 and January 2020. The BODY-Q Work Life scale was used to measure work life satisfaction. The difference between BMI groups and work life satisfaction was examined using one-way analysis of variance. Multivariable linear regression analysis was used to examine the association between BMI and work life satisfaction, adjusted for significant confounders. Of 4123 participants, 2515 completed the BODY-Q Work Life scale. BMI groups showed significant difference in work life satisfaction (p < .0001). The Work Life scale mean score was 77.6 for the normal BMI group, 78.5 for the overweight group and 75.0, 68.9 and 63.8 for Class 1, 2 and 3 obesity, respectively. Furthermore, BMI was significantly associated with satisfaction with work life (adjusted regression coefficient -.962, p < .0001). Higher BMI was associated with lower work life satisfaction. This finding suggests that a reduction in BMI may have a positive influence on work life satisfaction in people with obesity.

Patient-Level Factors Associated with Health-Related Quality of Life and Satisfaction with Body After Bariatric Surgery: a Multicenter, Cross-Sectional Study.

BACKGROUND: Health-Related Quality of Life (HRQL) is a key outcome of success after bariatric surgery. Not all patients report improved HRQL scores postoperatively, which may be due to patient-level factors. It is unknown which factors influence HRQL after surgery. Our objective was to assess patient-level factors associated with HRQL after surgery. METHODS: This international cross-sectional study included 730 patients who had bariatric surgery. Participants completed BODY-Q scales pertaining to HRQL and satisfaction with body, and demographic characteristics were obtained. The sample was divided into three groups based on time since surgery: 0 - 1 year, 1 - 3 years and more than 3 years. Uni- and multivariable linear regression analyses were conducted to identify variables associated with the BODY-Q scales per group. RESULTS: The 0 - 1 year postoperative group included 377 patients (50.9%), the 1 - 3 years postoperative group 218 (29.4%) and the more than 3 years postoperative group 135 patients (18.2%). Lower current body-mass index (BMI), more weight loss (%TWL), being employed, having no comorbidities, higher age and shorter time since surgery were significantly associated with improved HRQL outcomes postoperatively. None of these factors influenced all BODY-Q scales. The effect of current BMI increased with longer time since surgery. CONCLUSION: Factors including current BMI, %TWL, employment status, presence of comorbidities, age and time since surgery were associated with HRQL postoperatively. This information may be used to optimize patient-tailored care, improve patient education and underline the importance of long-term follow-up with special attention to weight regain to ensure lasting improvement in HRQL.

Lost in translation: A qualitative analysis of facilitators and barriers to collecting patient reported outcome measures for surgical patients with limited English proficiency.

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly being used throughout surgical disciplines, but their use is limited in multilingual patient populations. We aimed to investigate facilitators and barriers to PROMs collection for patients with limited English proficiency (LEP). METHODS: Semi-structured interviews were performed with providers from multiple surgical disciplines across six academic medical centers until thematic saturation was achieved. RESULTS: Among 24 interviews, respondents noted either systematic exclusion of patients with LEP or significant barriers to implementation. Barriers included lack of valid and translated PROMs, lack of multi-lingual electronic medical record integration, and insufficient time and resources to accommodate patients with LEP. Facilitators to collection included institutional leadership and funding support for validating translations. CONCLUSION: These barriers may result in inadvertent but systematic exclusion of patients with LEP from outcomes datasets as well as clinical decision making. Future implementation projects should consider these themes when developing initiatives for more equitable PROMs collection and utilization.

Primary care physician's (PCP) perceived value of patient-reported outcomes (PROs) in clinical practice: a mixed methods study.

BACKGROUND: Patient-reported outcomes (PROs) can promote patient engagement, shared-decision making and improve the overall experience of care. However, PRO integration in the primary care clinical setting is limited. Exploring the perspectives of primary care physicians (PCPs) on PROs is key to understanding how they are being used in the clinical setting. We sought to elucidate this clinical perspective at one of the largest US health systems that has integrated a wide range of PROs into routine primary care. METHODS: Mixed methods study with both anonymous online surveys and in-person qualitative semistructured interviews conducted with PCPs to understand their clinical perspectives on the applications of the existing PROs. PCPs from the 19 affiliated clinics were prompted to complete the survey. Interviewed PCPs were selected via a combination of random and purposive selection from the PCP directory. RESULTS: Of 172 PCPs, 117 (68%) completed the online survey and 28 completed semistructured interviews. Most PCPs (77%) reviewed PRO responses with their patients. PCPs endorsed that PROs improve clinic efficiency and clinical management. However, PCPs have heterogeneous perspectives on the relevance of PROs in clinical practice, likely due to variations in clinic practice. For specific PRO instruments, PCPs reported anxiety and depression screening PROs to be most helpful. PCPs felt that PROs assisted with completing screening questions that are required by regulatory bodies. Barriers to using PROs include poor user-interface for both clinicians and patients and inadequate training. CONCLUSIONS: Most PCPs regularly use PRO data though there are mixed opinions about their clinical relevance. An adaptable, user-friendly PRO system has the potential to have meaningful clinical applications in primary care.

Patterns of Weight Loss Medication Utilization and Outcomes Following Bariatric Surgery.

BACKGROUND: Bariatric surgery is the most effective treatment for obesity; however, some patients experience significant weight regain. Weight loss medications (WLM) are being increasingly used in surgery patients with limited evidence. We examine weight loss outcomes in patients using WLM after bariatric surgery. METHODS: In a retrospective study, 197 bariatric surgery patients who started WLM between 2016 and 2019 at a single center were analyzed. Patients were categorized into 3 groups based on outcomes of the initial surgery: (1) Weight regainers (WR) = achieved goal weight loss after surgery (15% total body weight loss (TBWL) for sleeve gastrectomy (SG) and 25% TBWL for Roux-en-Y gastric bypass (RYGB)) with subsequent regain of > 20% of weight lost; (2) Adequate weight loss (AWL) = achieved goal weight loss without > 20% weight regain; (3) Non-responders (NR) = never achieved goal weight loss. Weight loss and medication use patterns were analyzed. RESULTS: Among the three categories, there was no significant difference in duration of medical therapy or %TBWL with medications. RYGB patients lost more weight than SG patients using WLM (p = 0.03). Of the medications used, patients treated with phentermine + topiramate had the highest likelihood of achieving 5%, 10%, and 15% weight loss. Compared to other 2 groups, AWL group initiated WLM earlier and experienced more weight loss when compared to their pre-operative weight or post-operative nadir. CONCLUSIONS: RYGB patients respond better to WLM than SG patients. Those who had started WLM before regaining weight (AWL) experienced greater overall weight loss, suggesting that proactive medical therapy at the time of weight plateau can help with greater total weight loss. Phentermine + topiramate is the most effective WLM in post-bariatric surgery patients.

Development and Validation of New BODY-Q Scales Measuring Expectations, Eating Behavior, Distress, Symptoms, and Work Life in 4004 Adults From 4 Countries.

PURPOSE: The BODY-Q is a rigorously developed patient-reported outcome measure (PROM) for patients seeking treatment for obesity and body contouring surgery. A limitation of the uptake of the BODY-Q in weight management treatments is the absence of scales designed to measure eating-specific concerns. We aimed to develop and validate 5 new BODY-Q scales measuring weight loss expectations, eating behaviors, distress, symptoms, and work life. MATERIAL AND METHODS: In phase 1 (qualitative), patient and expert input was used to develop and refine the new BODY-Q scales. In phase 2 (quantitative), the scales were field-tested in bariatric and weight management clinics in the United States (US), The Netherlands, and Denmark between June 2019 and January 2020. Data were also collected in the US and Canada in September 2019 through a crowdworking platform. Rasch measurement theory (RMT) analysis was used for item reduction and to examine reliability and validity. RESULTS: The new BODY-Q scales were refined through qualitative input from 17 patients and 20 experts (phase 1) and field-tested in 4004 participants (phase 2). All items showed ordered thresholds and good fit to the Rasch model. The RMT analysis provided evidence of reliability, with PSI values ≥0.72, Cronbach alpha values ≥0.83, and test-retest values ≥0.79. Better scores on 4 scales (exception expectations scale) correlated with lower BMI, with the strongest correlation between the eating-related distress scale scores and BMI (r= -0.249, P < 0.001). CONCLUSION: The new BODY-Q scales can be used in research and clinical practice to assess weight loss treatments from the patient perspective.

Edgetic perturbation models of human inherited disorders.

Cellular functions are mediated through complex systems of macromolecules and metabolites linked through biochemical and physical interactions, represented in interactome models as 'nodes' and 'edges', respectively. Better understanding of genotype-to-phenotype relationships in human disease will require modeling of how disease-causing mutations affect systems or interactome properties. Here we investigate how perturbations of interactome networks may differ between complete loss of gene products ('node removal') and interaction-specific or edge-specific ('edgetic') alterations. Global computational analyses of approximately 50,000 known causative mutations in human Mendelian disorders revealed clear separations of mutations probably corresponding to those of node removal versus edgetic perturbations. Experimental characterization of mutant alleles in various disorders identified diverse edgetic interaction profiles of mutant proteins, which correlated with distinct structural properties of disease proteins and disease mechanisms. Edgetic perturbations seem to confer distinct functional consequences from node removal because a large fraction of cases in which a single gene is linked to multiple disorders can be modeled by distinguishing edgetic network perturbations. Edgetic network perturbation models might improve both the understanding of dissemination of disease alleles in human populations and the development of molecular therapeutic strategies.