Lotte Poulsen

Danish translation and linguistic validation of the BODY-Q: a description of the process

BackgroundPatient-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.MethodsThe 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.ResultsThe 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.ConclusionsThe 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.

Patient Expectations of Bariatric and Body Contouring Surgery.

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.

Patient-reported Outcomes in Weight Loss and Body Contouring Surgery: A Cross-sectional Analysis Using the Body-q

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.

Psychometric Validation of the BODY-Q in Danish Patients Undergoing Weight Loss and Body Contouring Surgery

Background: A well-developed patient-reported outcome instrument is needed for use in Danish bariatric and body contouring patients. The BODY-Q is designed to measure changes in important patient outcomes over the entire patient journey, from obesity to post-body contouring surgery. The current study aims to psychometrically validate the BODY-Q for use in Danish patients. Methods: The process consisted of 3 stages: translation and linguistic validation, field-test, and data analysis. The translation was performed in accordance with the International Society for Pharmacoeconomics and Outcomes Research and World Health Organization guidelines, and field-test data were collected in 4 departments in 2 different hospitals. Field-test data were analyzed using Rasch Measurement Theory. Results: A total of 495 patients completed the Danish BODY-Q field-test 1–4 times, leading to a total of 681 assessments with an overall response rate at 76%. Cronbach &agr; values were ≥ 0.90, and person separation index values were in general high. The Rasch Measurement Theory analysis provided broad support for the reliability and validity of the Danish version of the BODY-Q scales. Item fit was outside the criteria for 34 of 138 items, and of these, 21 had a significant chi-square P value after Bonferroni adjustment. Most items (128 of 138) had ordered thresholds, indicating that response options worked as intended. Conclusion: The Danish version of the BODY-Q is a reliable and valid patient-reported outcome instrument for use in Danish bariatric and body contouring patients.

The BODY-Q Stretch Marks Scale: A Development and Validation 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, Cronbachs 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

International phase I study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q)

Introduction A 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 analysis This 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 dissemination This 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.