Body Contouring Surgery After Bariatric Surgery Improves Long-Term Health-Related Quality of Life and Satisfaction With Appearance: An International Longitudinal Cohort Study Using the BODY-Q.

OBJECTIVE: To examine health-related quality of life (HRQL) and satisfaction with appearance in patients who have undergone bariatric surgery (BS) with or without subsequent body contouring surgery (BCS) in relation to the general population normative for the BODY-Q. BACKGROUND: The long-term impact of BS with or without BCS has not been established using rigorously developed and validated patient-reported outcome measures. The BODY-Q is a patient-reported outcome measure developed to measure changes in HRQL and satisfaction with appearance in patients with BS and BCS. METHODS: Prospective BODY-Q data were collected from 6 European countries (Denmark, the Netherlands, Finland, Germany, Italy, and Poland) from June 2015 to February 2022 in a cohort of patients who underwent BS. Mixed-effects regression models were used to analyze changes in HRQL and appearance over time between patients who did and did not receive BCS and to examine the impact of patient-level covariates on outcomes. RESULTS: This study included 24,604 assessments from 5620 patients. BS initially led to improved HRQL and appearance scores throughout the first postbariatric year, followed by a gradual decrease. Patients who underwent subsequent BCS after BS experienced a sustained improvement in HRQL and appearance or remained relatively stable for up to 10 years postoperatively. CONCLUSIONS: Patients who underwent BCS maintained an improvement in HRQL and satisfaction with appearance in contrast to patients who only underwent BS, who reported a decline in scores 1 to 2 years postoperatively. Our results emphasize the pivotal role that BCS plays in the completion of the weight loss trajectory.

Improving the Impact of BODY-Q Scores Through Minimal Important Differences in Body Contouring Surgery: An International Prospective Cohort Study.

BACKGROUND: The BODY-Q is a widely used patient-reported outcome measure for comprehensive assessment of treatment outcomes specific to patients undergoing body contouring surgery (BCS). However, for BODY-Q to be meaningfully interpreted and used in clinical practice, minimal important difference (MID) scores are needed. A MID is defined as the smallest change in outcome measure score that patients perceive important. OBJECTIVES: The aim of this study was to determine BODY-Q MID estimates for patients undergoing BCS to enhance the interpretability of the BODY-Q. METHODS: Data from an international, prospective cohort from Denmark, Finland, Germany, Italy, the Netherlands, and Poland were included. Two distribution-based methods were used to estimate MID: 0.2 standard deviations of mean baseline scores and the mean standardized response change of BODY-Q scores from baseline to 3 years postoperatively. RESULTS: A total of 12,554 assessments from 3,237 participants (mean age; 42.5±9.3 years; body mass index; 28.9±4.9 kg/m2) were included. Baseline MID scores ranged from 1 to 5 in the health-related quality of life (HRQL) scales and 3 to 6 in the appearance scales. The estimated MID scores from baseline to 3 years follow-up ranged from 4 to 5 in HRQL and from 4 to 8 in the appearance scales. CONCLUSIONS: The BODY-Q MID estimates from before BCS to 3 years postoperatively ranged from 4 to 8 and are recommended for use to interpret patients' BODY-Q scores, evaluate treatment effects of different BCS procedures, and for calculating sample size for future studies.

Validation of the Dutch Version of the BODY-Q Measuring Appearance, Health-Related Quality of Life, and Experience of Healthcare in Patients Undergoing Bariatric and Body Contouring Surgery.

BACKGROUND: The BODY-Q is a patient-reported outcome measure developed for use in bariatric and body contouring surgery. OBJECTIVES: The objective of this study was to examine the validity and reliability of the Dutch version of the BODY-Q. METHODS: The BODY-Q consists of 163 items in 21 independently functioning scales that measure appearance, health-related quality of life, and experience of care. The data used to validate the Dutch BODY-Q were provided by 2 prospective multicenter cohort studies across 3 hospitals in the Netherlands. The BODY-Q was administered before and after surgery at 3 or 4 months and 12 months. Rasch measurement theory (RMT) analysis was used to evaluate the BODY-Q for targeting, category threshold order, Rasch model fit, Person Separation Index, and differential item functioning by language (original English data vs Dutch data). RESULTS: Data were collected between January 2016 and May 2019. The study included 876 participants, who provided 1614 assessments. Validity was supported by 3 RMT findings: most scales showed good targeting, 160 out of 163 items (98.2%) evidenced ordered thresholds, and 142 out of 163 items (87.1%) fitted the RMT model. Reliability was high with Person Separation Index values >0.70 for 19 out of 21 scales. There was negligible influence of differential item functioning by language on person item locations and the scale scoring. CONCLUSIONS: This study provides evidence for the reliability and validity of the Dutch BODY-Q for use in bariatric and body contouring patients in the Netherlands. The Dutch BODY-Q can be used in (inter)national research and clinical practice.

Comparison of upper extremity lymphedema after sentinel lymph node biopsy and axillary lymph node dissection: patient-reported outcomes in 3044 patients.

PURPOSE: A limited number of studies have examined the impact of type of axillary lymph node surgery on breast cancer-related lymphedema (BCRL) from the patient's perspective. The objective of this study was to assess the impact of sentinel lymph node dissection (SLND) and axillary lymph node dissection (ALND) on the health-related quality of life (HRQOL) in women diagnosed with BCRL using a condition specific patient-reported outcome measure (PROM), the LYMPH-Q upper extremity (UE) module. METHODS: Adult women diagnosed with BCRL were identified from the Danish National Health Data Authority database for the period 2008 to 2020 and were sent an online REDCap survey with the LYMPH-Q UE module. Information pertaining to axillary surgery was obtained from an online pathology repository. Multivariable linear regression was used to examine differences in the SLND and ALND groups on the LYMPH-Q UE scale scores. RESULTS: Three thousand and fourty four women with BCRL were included in the analysis. The mean follow-up duration was 8.6 ± 5.15 years (range, 0-36 years). The majority of participants underwent ALND (n = 2805, 92.1%) and only 7.9% (n = 239) received SLND. The mean number of lymph nodes removed in the SLND group was 2.2 ± 1.4. No statistically significant difference was found in the two groups on the LYMPH-Q UE scale scores. CONCLUSION: There is no difference in women with upper extremity lymphedema after SLND or ALND on the LYMPH-Q UE module scales measuring arm symptoms, function, distress, and appearance.

Development and Psychometric Validation of BREAST-Q Scales Measuring Cancer Worry, Fatigue, and Impact on Work.

BACKGROUND: The BREAST-Q is a patient-reported outcome measure for women with breast cancer. The aim of this study was to develop new BREAST-Q scales to measure Cancer Worry, Fatigue and Impact on Work. METHODS: Data were collected between January 2017 and November 2019. Phase 1 (qualitative) included participants from Canada and the USA, pre/post any type of breast cancer treatment (surgery, adjuvant, neoadjuvant). Interviews were audio-recorded, transcribed verbatim and coded line-by-line. New scales were drafted and refined through cognitive interviews and expert input. Phase 2 (field-test study) involved USA members of the Love Research Army (LRA). Rasch measurement theory analysis was used to examine reliability and validity. RESULTS: In phase 1, 57 women were interviewed. Three concepts were identified as important to the breast cancer experience that are not currently covered in the BREAST-Q and developed into scales, i.e., Cancer Worry, Fatigue and Impact on Work. Feedback from nine women and 23 experts was used to establish content validity. The scales were field-tested in the LRA sample (n = 1680), of whom 1006 completed a test-retest. Reliability was > 0.81 for the person separation index, > 0.89 for Cronbach's alpha and > 0.83 for interclass correlation coefficients. Lower scores on all three scales were significantly associated with being closer in time to diagnosis and having a higher cancer stage at diagnosis (p < 0.001 on ANOVA). CONCLUSION: These new scales expand the BREAST-Q measurement system and provide a means to evaluate additional important outcomes for breast cancer patients in clinical care and research.

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.

The BODY-Q Cellulite Scale: A Development and Validation Study.

BACKGROUND: Cellulite is a localized metabolic disorder of the subcutaneous tissue. To measure the impact of cellulite and its treatment(s) on patients' health-related quality of life, a psychometrically sound patient-reported outcome measure is needed. OBJECTIVES: The authors sought to develop and field test a new BODY-Q cellulite scale to measure the appearance of cellulite. METHODS: Appearance-related codes from the original BODY-Q qualitative interviews were reexamined, and a set of cellulite-specific items was developed and refined through cognitive patient interviews (n = 10) and expert input (n = 17). This scale was field-tested in adults with cellulite through 2 crowdworking platforms. Rasch Measurement Theory analysis was employed to refine the scale and examine its psychometric properties. RESULTS: The field-test sample included 2129 participants. The 15-item scale was reduced in length to 11 items. Data from the sample fit the Rasch model (X2 [99] = 21.32, P = 0.06). All items had ordered thresholds and mapped out a targeted clinical hierarchy. The reliability statistics for the person separation index was 0.94 and for Cronbach's alpha was 0.97. In terms of validity, worse scores on the cellulite scale were associated with being more bothered by how the cellulite looked overall, having more severe cellulite on the Patient-Reported Photo-numeric Cellulite Severity Scale, and having more self-reported cellulite and more areas of the body with cellulite. CONCLUSIONS: The BODY-Q cellulite scale can be utilized to measure appearance of cellulite and provides a solid basis for future studies evaluating the impact of cellulite and its treatment.

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: study protocol for a randomized controlled trial (UPGRADE trial).

BACKGROUND: The number of bariatric interventions for morbid obesity is increasing worldwide. Rapid weight loss is a major risk factor for gallstone development. Approximately 11 % of patients who underwent Roux-en-Y gastric bypass develop symptomatic gallstone disease. Gallstone disease can lead to severe complications and often requires hospitalization and surgery. Ursodeoxycholic acid (UDCA) prevents the formation of gallstones after bariatric surgery. However, randomized controlled trials with symptomatic gallstone disease as primary endpoint have not been conducted. Currently, major guidelines make no definite statement about postoperative UDCA prophylaxis and most bariatric centers do not prescribe UDCA. METHODS: A randomized, placebo-controlled, double-blind multicenter trial will be performed for which 980 patients will be included. The study population consists of consecutive patients scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy in three bariatric centers in the Netherlands. Patients will undergo a preoperative ultrasound and randomization will be stratified for pre-existing gallstones and for type of surgery. The intervention group will receive UDCA 900 mg once daily for six months. The placebo group will receive similar-looking placebo tablets. The primary endpoint is symptomatic gallstone disease after 24 months, defined as admission or hospital visit for symptomatic gallstone disease. Secondary endpoints consist of the development of gallstones on ultrasound at 24 months, number of cholecystectomies, side-effects of UDCA and quality of life. Furthermore, cost-effectiveness, cost-utility and budget impact analyses will be performed. DISCUSSION: The UPGRADE trial will answer the question whether UDCA reduces the incidence of symptomatic gallstone disease after Roux-en-Y gastric bypass or sleeve gastrectomy. Furthermore it will determine if treatment with UDCA is cost-effective. TRIAL REGISTRATION: Netherlands Trial Register (trialregister.nl) 6135 . Date registered: 21-Nov-2016.

Minimal important difference in weight loss following bariatric surgery: Enhancing BODY-Q interpretability.

BODY-Q is a patient-reported outcome measure for comprehensive assessment of outcomes specific to patients undergoing bariatric surgery. The clinical utility of BODY-Q is hampered by the lack of guidance on score interpretation. This study aimed to determine minimal important difference (MID) for assessment of BODY-Q. Prospective BODY-Q data from Denmark and the Netherlands pre- and post-bariatric surgery were collected. Two distribution-based methods were used to estimate MID by 0.2 standard deviations of baseline scores and the mean standardized response change of scores from baseline to 3-years postoperatively. In total, 5476 assessments from 2253 participants were included of which 1628 (72.3%) underwent Roux-en-Y gastric bypass, 586 (26.0%) sleeve gastrectomy, 33 (1.5%) gastric banding, and 6 (0.03%) other surgeries. The mean age was 45.1 ± 10.9 with a mean BMI of 46.6 ± 9.6. Baseline MID ranged from 1 to 4 in health-related quality of life (HRQL) and from 2 to 8 in appearance scales. The mean change of scores ranged from 4 to 5 in HRQL and from 4 to 7 in the appearance scales. The estimated MID for the change in BODY-Q HRQL and appearance scales ranged from 3 to 8 and is recommended for use to interpret BODY-Q scores and assess treatment effects in bariatric surgery.

Core Set of Patient-Reported Outcome Measures for Measuring Quality of Life in Clinical Obesity Care.

PURPOSE: The focus of measuring success in obesity treatment is shifting from weight loss to patients' health and quality of life. The objective of this study was to select a core set of patient-reported outcomes and patient-reported outcome measures to be used in clinical obesity care. MATERIALS AND METHODS: The Standardizing Quality of Life in Obesity Treatment III, face-to-face hybrid consensus meeting, including people living with obesity as well as healthcare providers, was held in Maastricht, the Netherlands, in 2022. It was preceded by two prior multinational consensus meetings and a systematic review. RESULTS: The meeting was attended by 27 participants, representing twelve countries from five continents. The participants included healthcare providers, such as surgeons, endocrinologists, dietitians, psychologists, researchers, and people living with obesity, most of whom were involved in patient representative networks. Three patient-reported outcome measures (patient-reported outcomes) were selected: the Impact of Weight on Quality of Life-Lite (self-esteem) measure, the BODY-Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), and the Quality of Life for Obesity Surgery questionnaire (excess skin). No patient-reported outcome measure was selected for stigma. CONCLUSION: A core set of patient-reported outcomes and patient-reported outcome measures for measuring quality of life in clinical obesity care is established incorporating patients' and experts' opinions. This set should be used as a minimum for measuring quality of life in routine clinical practice. It is essential that individual patient-reported outcome measure scores are shared with people living with obesity in order to enhance patient engagement and shared decision-making.

Health-Related Quality of Life effects of rectus repair during body contouring surgery in post-bariatric patients: A prospective study.

BACKGROUND: Massive weight loss after bariatric surgery often leads to psychological and physical dissatisfaction, resulting in an increased demand for body contouring surgery (BCS). As a result of these surgeries, Health-Related Quality of Life (HRQL) is improved. However, little is known about the impact of rectus plication during BCS on HRQL. METHODS: This multicenter prospective cohort study included post-bariatric primary BCS patients with a minimum follow-up period of 12 months between January 2016 and December 2019. Patients were divided into two groups based on plication status. Using the BODY-Q, a patient-reported outcome measure, HRQL was measured preoperatively and at least 12 months postoperatively. Six HRQL domains were investigated: Body image, physical function, psychological function, sexual function, social function, and physical symptoms. RESULTS: A total of 305 patients were included in this study: 201 of these patients (66%) did not undergo plication, while 104 patients (34%) did. HRQL improved significantly 12 months after BCS in all measured domains, regardless of plication status. Delta scores were significantly higher in the plication group in all HRQL domains. After adjusting for baseline score and other significant variables through multivariate linear regression, three scales remained significant: Body image (P = 0.001), psychological function (P = 0.035), and sexual function (P = 0.035). CONCLUSIONS: Three out of six domains showed significant improvement in HRQL after BCS with rectus plication, predominantly body image. Preoperative counseling and surgical planning could benefit from this information. The long-term effects of rectus plication on HRQL should be explored in future research.

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 Image and Weight Loss Outcome After Bariatric Metabolic Surgery: a Mixed Model Analysis.

PURPOSE: As in nonsurgical weight loss populations, body image may partly explain differences in weight loss outcomes after surgery. The aim of this study was to determine the prospective association between body image and weight loss in a longitudinal cohort of patients up to 3 years after bariatric metabolic surgery. MATERIALS AND METHODS: The BODY-Q self-report questionnaire was used to assess body image. Linear mixed models evaluated associations of baseline body image with weight loss in the first year as well as associations of body image at 12 months and first-year change in body image with weight loss 12 to 36 months after surgery. RESULTS: Available body image data included 400 (100%), 371 (93%), 306 (77%), 289 (72%), and 218 (55%) patients at baseline and 4, 12, 24, and 36 months, respectively. Body image scores improved significantly until 12 months, followed by a gradual decline. Scores remained improved in comparison to baseline (ß = 31.49, 95% CI [27.8, 35.2], p < .001). Higher baseline body image was associated with less weight loss during the first year, and the effect size was trivial (ß = -0.05, 95% CI [-0.09, -0.01], p = .009). Body image and change in body image were not associated with weight loss 12 to 36 months after surgery. CONCLUSION: Body image improved after bariatric metabolic surgery. Although no clinically relevant associations of body image with weight loss were demonstrated, the gradual decline in body image scores underlines the importance of long-term follow-up with regular assessment of this aspect of quality of life.

Using the BODY-Q to develop a prospective cohort of patients undergoing bariatric and body contouring surgery: A study protocol.

The BODY-Q is a patient-reported outcome measure designed to measure health-related quality of life, satisfaction with appearance and experience with healthcare in patients with obesity who undergo bariatric surgery and/or body contouring surgery after massive weight loss. The aim of this study is to collect long term PRO-data from patients living with obesity undergoing bariatric surgery, comparing patient undergoing or not undergoing body contouring surgery. This study will be a multicentre, prospective longitudinal cohort study with participation of three bariatric medical centres in the Netherlands. The BODY-Q will be used to measure the satisfaction with appearance and HRQL. Patients undergoing bariatric surgery, age >18 years and <65 years and who are able to read and understand Dutch can be included. All bariatric procedures are eligible for inclusion. Administration of the questionnaires will be done preoperatively for bariatric and body contouring surgery as well as at 3, 12, 24, 36, 48 and 60 months post-operatively. Patient-reported outcomes measurements are becoming more important with the shift to patient-centred healthcare. The collected longitudinal data can be helpful in determining the effectiveness and value of bariatric and body contouring surgery from the patient's perspective, and can contribute to patient tailored postoperative care.

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.

Predictors of improved psychological function after bariatric surgery.

BACKGROUND: Negative psychological sequelae have been reported after bariatric surgery. It is unclear which factors affect psychological function in the first postoperative years. OBJECTIVE: Evaluation of significant predictors of improved psychological function following bariatric surgery by analyzing data from the BODY-Q questionnaire. SETTING: Multicenter prospective cohort in 3 centers located in The Netherlands and Denmark. METHODS: The BODY-Q questionnaire was used to assess 6 domains of health-related quality of life. The domain of interest, psychological function, consists of 10 questions from which a converted score of 0 (low) to 100 (high) can be calculated. Linear mixed models were used to analyze which patient characteristics were most predictive of the psychological function score. Secondary outcomes of interest were cross-sectional scores of psychological function and the impact of weight loss, and the effect of major short-term complications on psychological function. RESULTS: Data were analyzed from 836 patients who underwent bariatric surgery from 2015 to 2020. Patients with lower expectations concerning weight loss (<40% desired total weight loss), higher educational level, no history of psychiatric illness, and employment before bariatric surgery demonstrated the highest psychological function scores after bariatric surgery. At 1 and 2 years after bariatric surgery, more weight loss was associated with significantly higher psychological function scores. Experiencing a major short-term complication did not significantly impact psychological function. CONCLUSIONS: Several relevant predictors of improved postoperative psychological function have been identified. This knowledge can be used to enhance patient education preoperatively and identify patients at risk for poor psychological functioning postoperatively.

Understanding Breast Implant-Associated Illness: A Delphi Survey Defining Most Frequently Associated Symptoms.

BACKGROUND: Increased understanding of the constellation of symptoms referred to as breast implant illness is necessary to better address patient concerns, provide evidence-based care, and inform prospective patients about potential risks. The aim of this study was to reach consensus on the symptoms most frequently associated with breast implant illness, which will subsequently inform the development of a symptom severity scale. METHODS: A literature search of peer-reviewed and gray literature was performed to identify a comprehensive list of symptoms associated with breast implant illness. This was followed by an online, three-round, modified Delphi survey where the list of symptoms was reviewed by an international panel to determine the top 20, 10, and five symptoms associated with breast implant illness. A virtual meeting of panelists was held to reach consensus on the symptoms to be included in a symptom severity scale. RESULTS: A total of 44 symptoms were identified through the literature search. The modified Delphi survey panel consisted of patient research partners [n = 9 (34.6 percent)], plastic surgeons [n = 10 (38.5 percent)], researchers [n = 6 (23.1 percent)], and a member of the U.S. Food and Drug Administration [n = 1 (3.8 percent)]. The response rates of round 1, 2, and 3 were 85, 96, and 100 percent, respectively. Consensus was reached on the top 19 and top six symptoms to be included in long and short forms of a symptom severity scale. CONCLUSIONS: There was a high level of agreement on the symptoms to be included in a symptom severity scale. The next steps include conducting in-depth qualitative interviews with women with these symptoms and breast implants to understand the experience and impact of these symptoms and develop the preliminary scale.

Is the RAND-36 an Adequate Patient-reported Outcome Measure to Assess Health-related Quality of Life in Patients Undergoing Bariatric Surgery?

PURPOSE: The RAND-36 is the most frequently used patient-reported outcome measure (PROM) to evaluate health-related quality of life (HRQoL) in bariatric surgery. However, the RAND-36 has never been adequately validated in bariatric surgery. The purpose of this study was to validate the RAND-36 in Dutch patients undergoing bariatric surgery. MATERIAL AND METHODS: To validate the RAND-36, the following measurement properties were assessed in bariatric surgery patients: validity (the degree to which the RAND-36 measures what it purports to measure (HRQoL)), reliability (the extent to which the scores of the RAND-36 are the same for repeated measurement for patients who have not changed in HRQoL), responsiveness (the ability of the RAND-36 to detect changes in HRQoL over time). RESULTS: Two thousand one hundred thirty-seven patients were included. Validity was not adequate due to the irrelevance of some items and response options, the lack of items relevant to patients undergoing bariatric surgery, and the RAND-36 did not actually measure what it was intended to measure in this study (HRQoL in bariatric surgery patients). Reliability was insufficient for the majority of the scales (the scores of patients who had not changed in HRQoL were different when the RAND was completed a second time (intraclass correlation coefficient (ICC) values 0.10-0.69)). Responsiveness was insufficient. CONCLUSION: The RAND-36 was not supported by sufficient validation evidence in patients undergoing bariatric surgery, which means that the RAND-36 does not adequately measure HRQoL in this patient population. Future research studies should use PROMs that are specifically designed for assessing HRQoL in patients undergoing bariatric surgery.

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.