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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 (

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.

Background To better quantify the impact that breast cancer-related arm lymphedema (BCRL) has on health-related quality of life (HR-QOL), a disease-specific patient-reported outcome measure (PROM) is needed. The LYMPH-Q Upper Extremity Module was recently developed for patients with BCRL. The aim of this study was to perform an advanced translation and culturally adapt the LYMPH-Q Upper Extremity Module for use in Denmark. Methods The LYMPH-Q Upper Extremity Module was translated into Danish according to the guidelines of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the World Health Organization (WHO). The process included two forward and one back translation, an expert panel meeting, and cognitive debriefing interviews with patients. The focus of the translation was to develop a Danish version that used appropriate patient-friendly language while maintaining the meaning of the items, instructions and response options. Results The two forward translations resulted in minor differences in terminology. These discrepancies were discussed among the translators and a harmonized Danish version 1 was achieved. Comparison of the back translation to the original English version identified 14 items/instructions/response options that required re-translation. Subsequently, experts helped to identify and resolve the language for 10 items/instructions/response options that did not maintain the same meaning as the English version. Participants in the cognitive debriefing interviews did not report any difficulties with understanding the items/instructions/response options. Conclusions The translation and cultural adaption process led to the development of a conceptually equivalent Danish version of the LYMPH-Q Upper Extremity Module. Level of Evidence: Not gradable

Background: Due to lack of validated body contouring-specific patient-reported outcome (PRO) instruments, the outcomes of abdominoplasty after massive weight loss have been evaluated rather rarely and mainly using generic health-related quality of life (HRQoL) instruments. The aim of the current study was to examine, using body contouring-specific (BODY-Q) and generic (15D) HRQoL instruments, the HRQoL, and key factors related to HRQoL among patients having undergone massive weight loss and abdominoplasty. Methods: Altogether 52 patients who underwent abdominoplasty due to massive weight loss completed the BODY-Q and the 15D HRQoL instruments. The 15D scores were compared to those of age-, gender-, and BMI-adjusted control sample of the general population. Results: The mean score of the BODY-Q Abdomen scale was 50.7 out of 100 (SD 24.4). The HRQoL of abdominoplasty patients was lower than that of age-, gender-, and BMI-adjusted general population (p = 0.001). Sleeping, discomfort and symptoms, depression, excretion, and sexual activity were the patients' main concerns. Body image and psychological well-being were strongly associated with the perceived HRQoL. The satisfaction with appearance of the abdominal area was not associated with generic HRQoL. Conclusions: The HRQoL of abdominoplasty patients is lower than that of general population with similar age, gender and BMI. The most important factors associated with the HRQoL of the patients were body image, psychological well-being, and physical function. (C) 2020 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Patient‐reported outcome measures (PROMs) for chronic wounds mainly focus on specific types of wounds. Our team developed the WOUND‐Q for use with all types of wounds in any anatomic location. We conducted 60 concept elicitation interviews with patients in Canada, Denmark, the Netherlands, and the United States. Analysis identified concepts of interest to patients and scales were formed and refined through cognitive interviews with 20 patients and input from 26 wound care experts. Scales were translated into Danish and Dutch. An international field‐test study collected data from 881 patients (1020 assessments) with chronic wounds. Rasch measurement theory (RMT) analysis was used to refine the scales and examine psychometric properties. RMT analysis supported the reliability and validity of 13 WOUND‐Q scales that measure wound characteristics (assessment, discharge, and smell), health‐related quality of life (life impact, psychological, sleep impact, and social), experience of care (information, home care nurses, medical team, and office staff), and wound treatment (dressing and suction device). The WOUND‐Q can be used to measure outcomes in research and clinical practice from the perspective of patients with any type of wound.

Background A multiphased mixed-methods study was performed to develop and validate a comprehensive patient-reported outcome measure (PROM) for arm lymphedema in women with breast cancer (i.e., the LYMPH-Q Upper Extremity Module). Methods Qualitative interviews (January 2017 and June 2018) were performed with 15 women to elicit concepts specific to arm lymphedema after breast cancer treatment. Data were audio-recorded, transcribed, and coded. Scales were refined through cognitive interviews (October and Decemeber 2018) with 16 patients and input from 12 clinical experts. The scales were field-tested (October 2019 and January 2020) with an international sample of 3222 women in the United States and Denmark. Rasch measurement theory (RMT) analysis was used to examine reliability and validity. Results The qualitative phase resulted in six independently functioning scales that measure arm symptoms, function, appearance, psychological function, and satisfaction with information and with arm sleeves. In the RMT analysis, all items in each scale had ordered thresholds and nonsignificant chi-square p values. For all the scales, the reliability statistics with and without extremes for the Person Separation Index were 0.80 or higher, Cronbach’s alpha was 0.89 or higher, and the Intraclass Correlation Coefficients were 0.92 or higher. Lower (worse) scores on the LYMPH-Q Upper Extremity scales were associated with reporting of more severe arm swelling, an arm problem caused by cancer and/or its treatment, and wearing of an arm sleeve in the past 12 months. Conclusions The LYMPH-Q Upper Extremity Module can be used to measure outcomes that matter to women with upper extremity lymphedema. This new PROM was designed using a modern psychometric approach and, as such, can be used in research and in clinical care.

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.

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.

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.

The aim of this study was to translate and achieve a linguistical and cultural adaption of the newly developed BODY-Q Obesity Module for use in Danish patients. The BODY-Q Eating Module consists of five new modules aiming to measure expectations of weight-loss, eating behavior, eating-related distress, eating-related symptoms and work life. Translation and linguistic validation were performed using a combination of the recommendations developed by the World Health Organization and the International Society for Pharmacoeconomics and Outcomes Research. The translation was performed in five steps consisting of a forward translation, backward translation, expert panel meeting, cognitive debriefing and final proofreading. Each step aimed for a conceptual and cultural equal translation that was easily understood by patients. The discrepancies encountered in the forward translation included the use of layperson versus medical terminology, different tense and sentence structure. The harmonized version was then backwards translated which led to no conceptual differences. The expert panel reviewed the instrument in full and found two items needing correction in the instrument. Cognitive debriefing did not lead to any revisions and the instrument was well received by the participant group. Proofreading of the instrument led to few corrections in grammar and punctuation but no conceptual corrections. The translation of the BODY-Q Eating Module led to a conceptual and cultural equal version of the instrument for use in Danish patients. The instrument can be used in clinical care and research to inform advancements in the field of bariatric and body contouring surgery.

We present a rare case of microsurgical replantation of a total scalp avulsion. A woman in her mid-60s was renovating a tractor when her hair was caught in a column drill resulting in traumatic scalp avulsion. The avulsed scalp involved the eyebrows and the entire hair-covered part of the scalp. The prehospital management and the conservation packing of the scalp was very effective. Microsurgical replantation was achieved with anastomoses of the left superficial temporal artery and one temporal vein on each side. The combination of the prehospital treatment and our university hospital setup made it possible to reattach the scalp with an ischaemia time of approximately 5 hours. A functional and aesthetically pleasing outcome was achieved, and the patient was discharged 6 days postoperatively with a vital scalp and no complaints. Five months postoperatively, she has no sign of alopecia and is regaining sensation and function of the scalp.A woman in her mid-60s was renovating a tractor when her hair was caught in a column drill resulting in traumatic scalp avulsion. The avulsed scalp involved the eyebrows and the entire hair-covered part of the scalp. The prehospital management and the conservation packing of the scalp was very effective.

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.

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. Graphical abstract: [Figure not available: see fulltext.].

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.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.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, P0.001).The new BODY-Q scales can be used in research and clinical practice to assess weight loss treatments from the patient perspective.

Patient-reported outcome measures (PROMs) are questionnaires designed to measure outcomes of importance to patients from their perspective. The BODY-Q is a PROM designed to measure outcomes in weight loss and/or body contouring surgery. To develop the BODY-Q, a literature review, 63 patient interviews, 22 cognitive interviews, and input from 9 clinical experts were used to develop a conceptual framework that covers 3 broad domains: appearance concerns, health-related quality of life, and experience of care. For each aspect of the framework, multiple independently functioning scales were developed.

Traditional quality measures for chronic wounds have focused on objective outcomes that are challenging to risk adjust, lack patient input, and have limited ability to inform quality improvement interventions. Patient-reported experience measures (PREMs) provide information from the patient perspective regarding health care quality and have potential to improve patient-centredness, increase care efficiency, and generate actionable data for quality improvement. The purpose of this study was to understand patient experiences and health care processes that impact quality of care among patients with chronic wounds. Sixty patients at least 18 years of age with various wound aetiologies were recruited from Canada, Denmark, The Netherlands, and the United States as part of a larger phase 1 qualitative study to develop a patient-reported outcome measure for chronic wounds (WOUND-Q). All patients had a chronic wound for at least 3 months, were fluent in their native speaking language, and able to participate in a one-on-one semi-structured interview. Interviews were digitally recorded and transcribed verbatim. Interpretive description was used to identify recurrent themes relating to patient experience and quality of care. We identified five domains (care coordination, establishing/obtaining care, information delivery, patient-provider interaction, and treatment delivery) and 21 sub-domains (access to patient information, interdisciplinary communication, encounter efficiency, provider availability, specialist referral, staff professionalism, travel/convenience, modality, reciprocity, understandability/consistency, accountability, continuity, credentials, rapport, appropriateness, complication management, continuity, environment/setting, equipment and supply needs, expectation, and patient-centred) as potential opportunities to measure and improve quality of care in the chronic wound population. PREMs for chronic wounds represent an important opportunity to engage patients and longitudinally assess quality across clinical settings and providers. Future research should focus on developing PREMs to complement traditional objective and patient-reported outcome measures for chronic wounds.

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).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.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.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.

BACKGROUND: Health-related quality of life and satisfaction with appearance are important outcomes in bariatric and body contouring surgery. To investigate these outcomes, scientifically sound and clinically meaningful patient-reported outcome instruments are needed. The authors measured health-related quality of life and appearance in a cohort of Danish patients at different phases in the weight loss journey: before bariatric surgery, after bariatric surgery, before body contouring surgery, and after body contouring surgery.METHODS: From June of 2015 to June of 2016, a cross-sectional sample of 493 bariatric and body contouring patients were recruited from four different hospital departments. Patients were asked to fill out the BODY-Q, a new patient-reported outcomes instrument designed specifically to measure health-related quality of life and appearance over the entire patient journey, from obesity to the post-body contouring surgery period. Data were collected using REDCap, and analyzed using SPSS software.RESULTS: For all appearance and health-related quality-of-life scales, the mean score was significantly lower in the pre-bariatric surgery group compared with the post-body contouring group. Furthermore, the correlation between body mass index and mean scores was significant for all appearance and health-related quality-of-life scales, with higher scores associated with lower body mass index. The mean score for the group reporting no excess skin compared with the group reporting a lot of excess skin was significantly higher for five of seven appearance scales and four of five health-related quality-of-life scales.CONCLUSION: This study provides evidence to suggest that body contouring plays an important role in the weight loss patient's journey and that patients need access to treatments.

This study compared the measurement properties of the Moorehead-Ardelt quality of life questionnaire-II (MAQOL-II) and the BODY-Q, to determine which was more suitable for measuring patient-reported outcome (PRO) in Danish bariatric surgery (BS) and body contouring surgery (BC) patients. We examined content validity against the COSMIN guidelines and compared psychometric performance using Rasch measurement theory methods and criteria. MAQOL-II data were obtained from the Danish Bariatric Surgery Database from September 2010 to November 2017, and BODY-Q data were collected from June 2015 to March 2018. The MAQOL-II failed to meet recommended standards for content validity, while all criteria were met for the BODY-Q. A total of 16 965 MAQOL-II and 2259 BODY-Q assessments were obtained. A random sample was selected from the MAQOL-II dataset to match the BODY-Q sample. Psychometrically, the BODY-Q performed better than the MAQOL-II. For example, Cronbach's α was 0.82 for the MAQOL-II vs ≥0.90 for all BODY-Q scales. Fifty percent (3/6) of MAQOL-II items had disordered thresholds, while all BODY-Q items had ordered thresholds (123/123). Poor item fit was revealed for 17% (1/6) of MAQOL-II and 8% (10/123) of BODY-Q items. For scale reliability, person separation index was 0.79 for the MAQOL-II and 0.88 (0.81-0.93) for the BODY-Q. In conclusion, the MAQOL-II does not meet today's standards for a rigorously developed PRO measure. The BODY-Q, on the other hand, gives substantial, accurate and interpretable measurement and should be recommended for use in PRO in BS and BC patients.

Chronic wounds represent a significant problem to patients, healthcare professionals, and healthcare systems alike. The inclusion of patient-reported outcome measures (PROMs) into wound care outcome assessment will provide important information. The WOUND-Q is a new PROM developed to measure outcomes for people with chronic wounds. This study aimed to perform a linguistic validation/cultural adaption of the WOUND-Q from English into Danish and Dutch. The field-test version of the WOUND-Q is a comprehensive PROM composed of 222 items in 16 independently functioning scales. We followed the rigorous guidelines set forth by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the World Health Organization (WHO). These guidelines involved two forward translations, one back translation, an expert panel meeting, and cognitive debriefing interviews with patients. In the forward translation, the psychological function scale showed the greatest number of discrepancies from the English version. Comparison of the back translation of the Danish and Dutch versions with the English version identified 19 and 24 items respectively where the meaning had changed and required re-translation. A total of 38 cognitive debriefing interviews resulted in minor adjustments and demonstrated that the questionnaire had sufficient comprehensibility. The linguistic validation and cultural adaptation process is an essential step to adapting PROMs for use in other languages and cultures. The described method of translation and linguistic validation can be recommended for future translations of any PROM into any target language. The translation process led to conceptually equivalent Danish and Dutch versions of the WOUND-Q. Level of Evidence: Not ratable.

BACKGROUND: Plastic surgery to improve chest appearance is becoming increasingly popular. The BODY-Q is a patient-reported outcome instrument designed for weight loss and/or body contouring. In this article, the authors describe the development of a new module for masculinizing chest contouring surgery. METHODS: Qualitative methods were used to develop the BODY-Q Chest Module, which was subsequently field-tested in Canada, the United States, The Netherlands, and Denmark between June of 2016 and June of 2017. Participants were aged 16 years or older and seen for gynecomastia, weight loss, or transman chest surgery. Data were collected using either a Web-based application or paper questionnaire. Rasch measurement theory analysis was performed. RESULTS: The sample included 739 participants (i.e., 174 gynecomastia, 224 weight loss, and 341 gender-affirming). Rasch measurement theory analysis refined a 10-item chest scale and a five-item nipple scale. All items had ordered thresholds and good item fit, and scales evidenced reliability [i.e., person separation index and Cronbach alpha values were 0.95 and 0.98 (chest scale) and 0.87 and 0.94 (nipple scale), respectively]. Scores for both scales correlated more strongly with similar (satisfaction with the body) versus dissimilar (psychological and social function) BODY-Q scales. The mean scores for the chest and nipple scales were significantly higher (p < 0.001 on independent samples t tests) in participants who were postoperative compared with preoperative. CONCLUSION: This new BODY-Q Chest Module is a clinically meaningful and scientifically sound patient-reported outcome instrument that can be used to measure outcomes for masculinizing chest contouring surgery.

Patient-reported outcome measures (PROMs) are questionnaires designed to measure outcomes of importance to patients from their perspective. The BODY-Q is a PROM designed to measure outcomes in weight loss and/or body contouring surgery. To develop the BODY-Q, a literature review, 63 patient interviews, 22 cognitive interviews, and input from 9 clinical experts were used to develop a conceptual framework that covers 3 broad domains: appearance concerns, health-related quality of life, and experience of care. For each aspect of the framework, multiple independently functioning scales were developed.

The aim of this study was to translate and linguistically validate the patient-reported outcome (PRO) instrument body-q chest module, designed to measure outcomes following chest contouring surgery. The BODY-Q Chest Module includes two scales that measure appearance of chest and nipples. The translation and validation were performed according to the guidelines from the world health organization (who) and the international society for pharmacoeconomics and outcomes research (ISPOR). This approach involved two independent forward translations, a backwards translation, an expert panel meeting and cognitive debriefing interviews with patients. Each step was undertaken with the aim of achieving a conceptual and culturally equal instrument. This process led to a linguistically validated and conceptually equivalent danish version of the body-q chest module. The forward translation resulted in several discrepant translations of items that were harmonized to form the backward translation. This translation included three items with conceptual differences that required further revision. The revised version presented at the expert panel meeting had six items that needed to be revised due to conceptual discrepancies. The cognitive debriefing interviews led to revision of one item. The practices from the who and ispor guidelines were essential to developing a translation that preserved the meaning of the content of the body-q chest module from the original development study. The translation and linguistic validation methods used in our study could be used for further translations and validation of pro instruments. These new scales have since been field-tested as part of an international psychometric study.

Background Stretch marks are common permanent dermal lesions that can cause psychosocial distress. A number of treatment modalities are available, with the majority targeted towards collagen production. Objectives To develop and field test a new BODY-Q scale to measure appearance of stretch marks in order to provide a means to incorporate the patient perspective into future treatment studies. Methods We previously described the development of the BODY-Q conceptual framework, which involved a literature review, 63 patient interviews, 22 cognitive interviews and input from 9 experts, and the international field-test study that involved 403 weight loss and 331 body contouring patients. To develop the Stretch Marks scale, we reexamined appearance codes from the original interviews. The scale was field tested in an international study. Rasch measurement theory (RMT) analysis was used to refine the scale and examine measurement properties. Results The Stretch Marks scale was completed by 630 participants, who provided 774 assessments. After dropping 3 items, the data fit the Rasch model (P = 0.56). Items (eg, length, width, amount, location, up close) mapped out a well-targeted clinical hierarchy. All items had ordered thresholds and good item fit. There was no evidence of differential item functioning (bias) by gender, age group or language (English vs Danish). The scale evidenced high reliability (ie, person separation index = 0.94, Cronbach's alpha = 0.97). For construct validity, the mean score correlated with the total number of body areas with stretch marks, higher BMI before bariatric surgery, and other BODY-Q scales. Conclusions This scale could be used to measure the impact of innovative treatments for stretch marks. Level of Evidence 4

IntroductionA critical barrier to outcome assessment in gender-affirming healthcare is the lack of a specific patient-reported outcome measure (PROM). This phase I protocol describes an international collaboration between investigators in Canada, Denmark, the Netherlands and the USA who have coalesced to develop a new PROM (ie, the GENDER-Q) to evaluate outcomes of psychological, hormonal and surgical gender-affirming treatments.Methods and analysisThis phase I study uses an interpretive description approach. Participants aged 16 years and older seeking any form of gender-affirming treatments in centres located in Canada, Denmark, the Netherlands and the USA will be invited to take part in qualitative interviews. Participants will review BREAST-Q and FACE-Q scales hypothesised to contain content relevant to specific gender-affirming treatments. Interviews will elicit new concepts for additional scale development. Each interview will be digitally recorded, transcribed and coded. The main outcome of this phase I study will be the development of a conceptual framework and set of scales to measure outcomes important to evaluating gender-affirming treatments. To this end, analysis will be used to add/drop/revise items of existing scales to achieve content validity. For new concepts, coding will assign top-level domains and themes/subthemes to participant quotes. Codes will be used to develop an item pool to inform scale development. Draft scales will be shown to transgender and gender diverse persons and experts to obtain feedback that will be used to refine and finalise the scales. The field-test version of the GENDER-Q will be translated by following rigorous methods to prepare for the international field-test study.Ethics and disseminationThis study is coordinated at McMaster University (Canada). Ethics board approval was received from the Hamilton Integrated Ethics Board (Canada), the Medical Ethical Committee at VUmc (The Netherlands) and Advarra (USA). Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.

BACKGROUND: Patient-reported outcome (PRO) instruments are increasingly being included in research and clinical practice to assess the patient point of view. Bariatric and body contouring surgery has the potential to improve or restore a patient's body image and health-related quality of life (HR-QOL). A new PRO instrument, called the BODY-Q, has recently been developed specifically for this patient group. The aim of the current study was to translate and perform a linguistic validation of the BODY-Q for use in Danish bariatric and body contouring patients.METHODS: The translation was performed in accordance with the International Society For Pharmacoeconomics and Outcomes Research (ISPOR) and the World Health Organization (WHO) recommendations. Main steps taken included forward and backward translations, an expert panel meeting, and cognitive patient interviews. All translators aimed to conduct a conceptual translation rather than a literal translation and used a simple and clear formulation to create a translation understandable for all patients.RESULTS: The linguistic translation process led to a conceptually equivalent Danish version of the BODY-Q. The comparison between the back translation of the first Danish version and the original English version of the BODY-Q identified 18 items or instructions requiring re-translation. The expert panel helped to identify and resolve inadequate expressions and concepts of the translation. The panel identified 31 items or instructions that needed to be changed, while the cognitive interviews led to seven major revisions.CONCLUSIONS: The impact of weight loss methods such as bariatric surgery and body contouring surgery on patients' HR-QOL would benefit from input from the patient perspective. A thorough translation and linguistic validation must be considered an essential step when implementing a PRO instrument to another language and/or culture. A combination of the ISPOR and WHO guidelines contributed to a straightforward and thorough translation methodology well suited for a Danish translation of the BODY-Q. The described method of translation and linguistic validation can be recommended for future translations of PRO instruments in the field of plastic surgery. Level of Evidence: Not ratable.

Surgical treatment of obesity has led to a large group of patients with massive weight loss. The massive weight loss results in excessive skin, which leads to pain, skin problems, cosmetic discomfort and psychosocial issues. The impact on quality of life of bariatric and body contouring surgery can be measured by patient-specific, well-constructed psychometrically validated patient-reported outcome measures. A new patient-reported outcome measure, the Body-Q, has been translated for use in Danish patients.

Surgical treatment of obesity has led to a large group of patients with massive weight loss. The massive weight loss results in excessive skin, which leads to pain, skin problems, cosmetic discomfort and psychosocial issues. The impact on quality of life of bariatric and body contouring surgery can be measured by patient-specific, well-constructed psychometrically validated patient-reported outcome measures. A new patient-reported outcome measure, the Body-Q, has been translated for use in Danish patients

Summary Background Allergen-specific immunotherapy (SIT) is associated with increased levels of allergen-specific IgG in serum. However, it is not clear to what extent qualitative changes in the allergen binding capacity of IgG may be induced as well. Objective The purpose of this study was to investigate the influences of SIT on antibody affinity. Methods The binding affinity of purified serum IgG1, IgG4 and IgE to the major allergen in birch (Betula verrucosa) pollen, Bet v 1, was analysed by surface plasmon resonance. The antibodies were obtained from 10 birch pollen-allergic patients receiving SIT and from 10 patients with no SIT. Results The patients having received SIT have a significant higher titre of anti-Bet v 1 antibodies in their blood, but the affinity to Bet v 1 of allergen-specific IgE, IgG1 and IgG4 does not differ between the two groups. For IgG1 and IgG4, correlations between less allergic symptoms and affinity of the antibodies were observed both in the SIT group and to a smaller extent in the non-SIT group. Conclusion SIT has no effect on antibody affinity of allergen-specific IgE, IgG1 or IgG4. Allergic patients with high-affinity IgG1 and IgG4 antibodies report less symptoms than patients with low-affinity antibodies.

Supplemental Digital Content is available in the text., Background: Patient expectations are important in bariatric and body contouring surgery because the goals include improvements in health-related quality of life, appearance, and body image. The aim of this study was to identify patient expectations along the weight loss journey and/or body contouring surgery. Methods: This qualitative study took an interpretive description approach. Between September 2009 and February 2012, 49 patients were interviewed postbody contouring surgery. Data were analyzed using a line-by-line approach whereby expectations were identified and labeled as expected, unexpected, or neutral. Constant comparison was used to ensure coding was done consistently. Interviews continued until no new themes emerged. Results: Participants described expectations according to appearance, health-related quality of life, and patient experience of care. Two areas stood out in terms of unmet expectations and included appearance and physical health, ie, recovery from body contouring surgery. Most participants, who underwent bariatric surgery, expected neither the extent of excess skin after weight loss nor how the excess skin would make them look and feel. For recovery, participants did not expect that it would be as long or as hard as it was in reality. Conclusions: A full understanding of outcomes and expectations for this patient population is needed to enhance patient education and improve shared medical decision making. Education materials should be informed by the collection of evidence-based patient-reported outcome information using measures such as the BODY-Q. A patient-reported outcome scale measuring patient expectations is needed for obese and bariatric patients.

Patients with lung cancer are often burdened by dyspnoea, fatigue, decreased physical ability and loss of weight. Earlier studies of physical exercise of patients with COPD have shown promising results. The aim of this study was to investigate, if a well-documented COPD rehabilitation protocol can improve physical fitness and quality of life (QoL) in patients with lung cancer.Forty-five patients, with a minimum walking distance of 50 meters, absence of cognitive deficits or severe heart disease and motivated for physical training were invited to an exercise intervention. The intervention consisted of seven weeks of twice weekly training, focusing on walking training, circuit training, handling of dyspnoea and instructions in daily diary-based training at home. Prior to, and after the intervention, Incremental- and Endurance Shuttle Walk Test (ISWT and ESWT) were performed, and pulmonary function as well as self-reported QoL (EORTC-QLQ-C30 and LC13) were measured.Fourteen subjects dropped out before commencement of the intervention. Seven were excluded after physiotherapeutic evaluation. Of the remaining 24, three were excluded because of insufficient attendance (65% of scheduled exercise sessions) thus 21 patients completed the intervention. For 17 patients with complete pre- and post intervention data, ISWT increased 9% (-77 to 39%) (median and range) (p = 0.021), while ESWT increased 109% (-70 to 432%) (p = 0.002). Twelve of 17 improved in ISWT, while 15 improved in ESWT. No changes in pulmonary function and improvements in QoL were observed.Patients with pulmonary cancer can achieve significant improvements in physical fitness measured with ISWT and ESWT after completion of the intervention program. No changes in pulmonary function and QoL were observed. In addition, we found that a large number of patients dropped out before intervention and that the patients, who succeeded, often discontinued training at home.

Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, hyperactivity and impulsivity. The diagnostic classification is based on developmental anamnesis, objective examination, neuropsychological tests, observation of the child, and evaluation of the symptoms from rating scales.The internationally known ADHD rating scale (ADHD-RS) has been translated into Danish and representative norm data from teachers and parents were collected. A total of 1,718 ADHR-RS questionnaires were distributed to 859 anonymous school children, aged 6-17 years, and a total of 1,477 ADHD-RS questionnaires were returned. Analyses were made on 781 children, 420 boys and 361 girls.The average participation rate was 99.5% for teachers and 72.4% for parents. The factor structure was supported and internal consistency was high. The normative scores were calculated for both girls and boys in three age-groups, for parent answers and teacher answers separately.There were significant variations in ratings of ADHD and behavioural symptoms as a function of gender and age. It is crucial, during an evaluation of a child, to compare his or her scores to gender- and age-stratified normative data. Standardized normative ADHD-RS data from school children is now available and can be implemented in a national quality database within child and adolescent mental health services. The questionnaire can support the diagnostic classification, measure symptom-load and evaluate outcome of treatment of ADHD.