German Translation and Linguistic Validation of the LIMB­Q: A Patient-reported Outcome Measure for Lower Extremity Trauma.

Background: Lower extremity trauma can have a significant impact on a patient's quality of life. The LIMB-Q is a recently developed and validated patient-reported outcome measure that assesses patient-specific outcomes and experience of health care. The aim of this study was to translate and linguistically validate the LIMB-Q from English to German. Methods: The translation was performed by combining World Health Organization and Professional Society for Health Economics and Outcomes Research guidelines. The process consisted of forward translations, a backward translation, expert panel meetings, cognitive debriefing interviews with patients, and several rounds of discussion and reconciliation with the creators of LIMB-Q. The goal was to obtain a culturally and conceptually accurate translation of LIMB-Q into German for use in Switzerland. Results: From the two forward translations, there was one primary discrepancy between the two translators that was discussed to determine the most conceptually accurate translation. From the backward translations, there were 63 items that required discussion and re-translation. Nine patients participated in the cognitive debriefing interviews, which led to three items being modified. The translation process led to a linguistically validated and conceptually equivalent German version of the LIMB-Q. Conclusions: The German (Switzerland) version of LIMB-Q is now available. This will offer a valuable tool for lower extremity trauma research and clinical care in German-speaking populations.

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.

Iterative qualitative approach to establishing content validation of a patient-reported outcome measure for arm lymphedema: the LYMPH-Q Upper Extremity Module.

BACKGROUND: Breast cancer-related lymphedema (BRCL) is one of the most common causes of upper extremity (UE) lymphedema in developed nations and substantially impacts health-related quality of life. To advance our understanding of the epidemiology and treatment of BRCL, rigorously developed and validated patient-reported outcome measures (PROMs) are needed. This study aimed to demonstrate the iterative content validity of a modular UE lymphedema-specific PROM called the LYMPH-Q UE module. METHODS: A multi-step iterative qualitative approach was used. Semi-structured interview data from in-depth qualitative interviews with adult women (18 years and older) with BCRL were used to develop the first set of the LYMPH-Q UE scales. The content validity of these scales was demonstrated with patient and clinician feedback. Over the course of cognitive debriefing interviews, additional concepts of lymphedema worry and impact on work were identified as missing from the LYMPH-Q UE module. Subsequently, two new qualitative studies (a focus group and in-depth concept elicitation interviews with patients) were conducted, and two new scales were developed to measure lymphedema worry and impact on work life and their content validity was demonstrated. RESULTS: Qualitative data from in-depth and cognitive interviews with 15 (age 40-74 years) and 16 (age 38-74 years) women with BRCL, respectively, and feedback from 12 clinical experts, were used to develop and demonstrate the content validity of six LYMPH-Q UE scales measuring symptoms, function, appearance, psychological, information, and arm sleeve. Additionally, data from in-depth interviews with 12 (age 35-72 years) women with UE lymphedema and four focus groups (n = 16 women; age 35-74 years) was used to develop and assess the content validity of two new LYMPH-Q UE scales measuring lymphedema worry and impact on work life. The content validity of the previously established six scales was also demonstrated in these subsequent qualitative studies. CONCLUSION: The LYMPH-Q UE is a modular PROM developed using international guidelines for PROM development and can be used in clinical practice, research, and quality improvement to enhance patient-centered shared decision-making. This study's innovative and iterative approach to content validation demonstrates that the LYMPH-Q UE is a comprehensive measure that includes important concepts relevant to patients with UE lymphedema.

Establishing test-retest reliability and the smallest detectable change of FACE-Q Aesthetic Module scales.

BACKGROUND: The test-retest (TRT) reliability of FACE-Q Aesthetic scales is yet to be assessed. The aim of this study was to establish the TRT reliability of 17 FACE-Q Aesthetic scales and determine the smallest detectable change (SDC) that can be identified using these scales. METHODS: Data were collected from an online international sample platform (Prolific). Participants ≥20 years old, who had been to a dermatologist or plastic surgeon for a facial aesthetic treatment within the past 12 months were asked to provide demographic and clinical information and complete an online REDcap survey consisting of 17 FACE-Q Aesthetic scales. Participants were asked if they would be willing to complete the survey again in 7 days. Only the participants who reported no important change in the scale construct and completed the retest within 14 days were included. RESULTS: A total of 342 unique participants completed the TRT survey. The mean age of the sample was 36.6 (±11.5) years, and 82.4% were female. With outlier data removed, all FACE-Q scales demonstrated an intraclass correlation coefficient >0.70 indicating "good" TRT reliability. The standard error of measurement for the included scales ranged from 3.37 to 11.87, corresponding to a range of SDCgroup from 0.95 to 3.23 and SDCind from 9.34 to 32.91. CONCLUSION: All included FACE-Q scales demonstrated sufficient TRT reliability and stability overall after the outlier data were removed. Moreover, the authors calculated the values for the SDC for these scales.

Patient factors associated with cancer worry post-breast reconstruction: A cross-sectional study.

PURPOSE: The BREAST-Q Breast Cancer module is a patient-reported outcome measure for women with breast cancer diagnosis. Our research team developed and validated a novel BREAST-Q scale for this module that measures quality of life outcomes specific to cancer worry. The aim of this study was to investigate patient related breast reconstruction factors that are associated with worse scores on the new BREAST-Q Cancer Worry Scale. METHODS: Women with a history of breast cancer treated with mastectomy and reconstruction, aged ≥18 years, and English-speaking were recruited through the Love Research Army between October and November 2019. Participants completed demographic and clinical questions alongside the BREAST-Q Cancer Worry Scale. Univariable and multivariable regression analyses were used to identify participant characteristics associated with cancer worry scores. RESULTS: Among the 554 potential respondents, 538 (97.1%) completed the Cancer Worry Scale. The average patient age was 58.4 (+9.8) years. Cancer Worry scores were normally distributed with a mean of 46.4 (+17.2). Cancer Worry scores were significantly associated (p < 0.01) with younger age, history of radiation therapy, complications associated with breast surgery since diagnosis, use of textured breast implants, and shorter duration since surgery. CONCLUSIONS: This exploratory analysis provides evidence of patient characteristics that may be associated with cancer worry following postmastectomy breast reconstruction.

Extracting big data from the internet to support the development of a new patient-reported outcome measure for breast implant illness: a proof of concept study.

PURPOSE: Individuals with health conditions often use online patient forums to share their experiences. These patient data are freely available and have rarely been used in patient-reported outcomes (PRO) research. Web scraping, the automated identification and coding of webpage data, can be employed to collect patient experiences for PRO research. The objective of this study was to assess the feasibility of using web scraping to support the development of a new PRO measure for breast implant illness (BII). METHODS: Nine publicly available BII-specific web forums were chosen post-consultation with two prominent BII advocacy leaders. The Python Selenium and Pandas packages were used to automate extraction of de-identified text from the individual posts/comments into a spreadsheet. Data were coded using a line-by-line approach and constant comparison was used to create top-level domains and sub-domains. RESULTS: 6362 unique codes were identified and organized into four top-level domains of information needs, symptom experiences, life impact of BII, and care experiences. Information needs of women included seeking/sharing information pre-breast implant surgery, post-breast implant surgery, while contemplating explant surgery, and post-explant surgery. Symptoms commonly described by women included fatigue, brain fog, and musculoskeletal symptoms. Many comments described BII's impact on daily activities and psychosocial wellbeing. Lastly, some comments described negative care experiences and experiences related to advocating for themselves to providers. CONCLUSION: This proof-of-concept study demonstrated the feasibility of employing web scraping as a cost-effective, efficient method to understand the experiences of women with BII. These data will be used to inform the development of a BII-specific PROM.

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.

Patient factors associated with novel EAR-Q appearance, psychosocial, and social scales: A cross-sectional study and regression analysis.

INTRODUCTION: The EAR-Q is a rigorously validated patient-reported outcome measure, which evaluates ear appearance and health-related quality of life (HRQL) in patients with congenital or acquired ear conditions. The aim of this study was to conduct an exploratory analysis to examine the factors associated with EAR-Q appearance and HRQL scale scores. METHODS: In this study, 862 participants, aged 8-29 years, with congenital or acquired ear conditions, completed the EAR-Q as part of an international field-test study. Patients responded to demographic and clinical questions as well as the EAR-Q. Univariable and multivariable linear regression analyses were used to determine factors that were significant predictors for the scores on the EAR-Q Appearance, Psychological, and Social scales. RESULTS: Most participants were men (57.4%), awaiting treatment (55.0%), and had a microtia diagnosis (70.4%), with a mean age of 13 (±4) years. Worse ear appearance scores (p < 0.02) were associated with male gender, microtia, no history of treatment, ear surgery within 6 months, unilateral involvement, and greater self-reported ear asymmetry. Decreased psychological scores (p < 0.01) were associated with increasing participant age, no treatment history, recent ear surgery, and dissatisfaction with ears matching or overall dissatisfaction. Lower social scores (p ≤ 0.04) were associated with no treatment history, those awaiting surgery, ear surgery within the last 6 months, bilateral involvement, and self-reported ears matching or overall appearance. CONCLUSION: This analysis identified patient factors that may influence ear appearance and HRQL scale scores. These findings provide evidence of patient factors that should be adjusted for when undertaking future observational research designs using the EAR-Q in this patient population.

Extending the Range of Measurement for Minimally Invasive Treatments by Adding New Concepts to FACE-Q Aesthetics Scales.

Background: The Satisfaction with Face Overall and Psychological Function scales are the most frequently used FACE-Q Aesthetics module scales. This study aimed to extend their range of measurement by adding and testing new concepts. We aimed to create FACE-Q Aesthetics item libraries. Methods: In-depth concept elicitation interviews were conducted. Concepts were formed into items and refined through multiple rounds of patient and expert input. The items were tested with people living in the United States, Canada, and the United Kingdom who had minimally invasive facial aesthetic treatments. Participants were recruited through an online platform (ie, Prolific). Psychometric properties were examined using Rasch measurement theory analysis, test-retest reliability, and construct validity. Results: We conducted 26 interviews. New concepts were developed into items and refined with input from 12 experts, 11 clinic patients, and 184 Prolific participants. A sample of 1369 Prolific participants completed 52 appearance and 22 psychological items. After removing 10 and 2 items respectively, the psychometric tests provided evidence of reliability with the person separation index, Cronbach alpha, and test-retest reliability values without extremes of 0.88 or more. For validity, lower scores were associated with looking older than one's age, being more bothered by facial skin laxity, treatment wearing off, and having deeper lines on Merz Assessment scales. Short-form scales formed from the 42 appearance items provide examples of item library application. Conclusions: This study provides an innovative means to customize scales to measure appearance and psychological function that maximizes content validity and minimizes respondent burden in the context of minimally invasive treatments.

The SKIN-Q: An Innovative Patient-Reported Outcome Measure for Evaluating Minimally Invasive Skin Treatments for the Face and Body.

Background: As the aesthetics field continues to innovate, it is important that outcomes are carefully evaluated. Objectives: To develop item libraries to measure how skin looks and feels from the patient perspective, that is, SKIN-Q. Methods: Concept elicitation interviews were conducted and data were used to draft the SKIN-Q, which was refined with patient and expert feedback. An online sample (i.e., Prolific) provided field-test data. Results: We conducted 26 qualitative interviews (88% women; 65% ≥ 40 years of age). A draft of the SKIN-Q item libraries were formed and revised with input from 12 experts, 11 patients, and 174 online participants who provided 180 survey responses. The psychometric sample of 657 participants (82% women; 36% aged ≥40 years) provided 713 completed surveys (facial, n = 595; body, n = 118). After removing 14 items, the psychometric analysis provided evidence of reliability (≥0.85) and validity for a 20-item set that measures how skin feels and a 46-item set that measures how skin looks. Short-form scales were tested to provide examples for how to utilize the item sets. Conclusion: The SKIN-Q represents an innovative way to measure satisfaction with skin (face and body) in the context of minimally invasive treatments.

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.

Identifying health-related quality of life concepts to inform the development of the WOUND-Q.

OBJECTIVE: The impact of hard-to-heal wounds extends beyond traditional clinical metrics, negatively affecting a patient's health-related quality of life (HRQoL). Yet treatment outcomes are seldom measured from the patient's perspective. The purpose of the present study was to perform in-depth qualitative interviews with patients diagnosed with varying types of hard-to-heal wounds to identify outcomes important to them. METHOD: Participants were recruited from wound care clinics in Canada, Denmark, the Netherlands and the US, and were included if they had a hard-to-heal wound (i.e., lasting ≥3 months), were aged ≥18 years, and fluent in English, Dutch or Danish. Qualitative interviews took place between January 2016 and March 2017. An interpretive description qualitative approach guided the data analysis. Interviews were audio-recorded, transcribed and coded line-by-line. Codes were categorised into top-level domains and themes that formed the final conceptual framework. RESULTS: We performed 60 in-depth interviews with patients with a range of wound types in different anatomic locations that had lasted from three months to 25 years. Participants described outcomes that related to three top-level domains and 13 major themes: wound (characteristics, healing); HRQoL (physical, psychological, social); and treatment (cleaning, compression stocking, debridement, dressing, hyperbaric oxygen, medication, suction device, surgery). CONCLUSION: The conceptual framework developed as part of this study represents the outcome domains that mattered the most to the patients with hard-to-heal wounds. Interview quotes were used to generate items that formed the WOUND-Q scales, a patient-reported outcome measure for patients with hard-to-heal wounds.

The LIMB-Q: Reliability and Validity of a Novel Patient-Reported Outcome Measure for Lower Extremity Trauma Patients.

BACKGROUND: The LIMB-Q is a novel patient-reported outcome measure for lower extremity trauma patients. The aim of this study was to perform a psychometric validation of the LIMB-Q based on the Rasch Measurement Theory. METHODS: An international, multi-site convenience sample of patients with lower extremity traumatic injuries distal to the mid-femur were recruited via clinical sites (United States, Netherlands) and online platforms (English; Trauma Survivors Network, Prolific). A cross-sectional survey of the LIMB-Q was conducted with test-rest (TRT) measured 1-2 weeks after initial completion in a sub-group of patients. RESULTS: The LIMB-Q was field-tested in 713 patients. The mean age was 41 years (standard deviation (SD) 17, range 18-85), mean time from injury was 7 years (SD 9, range 0-58), and there were variable injury and treatment characteristics (39% fracture surgery only, 38% flap or graft, 13% amputation, 10% amputation and flap/graft). Out of 382 items tested, 164 were retained across 16 scales. Reliability was demonstrated with person separation index values 0.80 and greater in 14 scales (0.78-0.79 in remaining 2 scales), Cronbach alpha values 0.83 and greater, and intraclass correlation coefficient values 0.70 and greater. Each scale was unidimensional, measurement invariance was confirmed across clinical and demographic factors, TRT showed adequate reliability, and construct validity was demonstrated. CONCLUSIONS: The LIMB-Q is a patient reported outcome measure with 16 independently functioning scales (6-15 items per scale) developed and validated specifically for lower extremity trauma patients with fractures, reconstruction, and/or amputation.

"I Want It to Look Natural": Development and Validation of the FACE-Q Aesthetics Natural Module.

BACKGROUND: The concept of "natural" after a facial aesthetic treatment represents an understudied area. We added scales to FACE-Q Aesthetics to provide a means to measure this concept from the patient's perspective. OBJECTIVES: The objective of this study was to develop and validate the FACE-Q Aesthetic Natural module. METHODS: Concept elicitation interviews with people having minimally invasive treatments were conducted to explore the natural concept and develop scales. Patient and expert input refined scale content. An online sample (ie, Prolific) of people who had a facial aesthetic treatment was analyzed with Rasch measurement theory to examine psychometric properties. A test-retest reliability study was performed, and construct validity was examined. RESULTS: Interviews with 26 people were conducted. Three scales were developed and refined with input from 12 experts, 11 patients, and 184 online survey participants. Data from 1358 online participants provided evidence of scale reliability and validity. Reliability was high with person separation index, Cronbach alpha, and intraclass correlation coefficient values without extremes ≥0.82. Tests of construct validity confirmed that the scales functioned as hypothesized. Higher scores on the Expectations scale were associated with how important it was to have a natural look and movement after treatment. In addition, higher scores on the Natural Appearance and Natural Outcome scales correlated with better scores on other FACE-Q Aesthetics scales, and were associated with the face looking and feeling natural and with overall satisfaction with facial appearance. CONCLUSIONS: Many people seeking facial aesthetic treatments want to look natural after treatment. These new FACE-Q Aesthetics scales provide a means to measure the concept of natural from the patient's perspective.

Establishing Reliability and Validity of the FACE-Q Craniofacial Module for Pediatric Head and Neck Cancer.

Purpose: We aimed to establish content validity and assess the psychometric properties of the FACE-Q Craniofacial Module, a patient-reported outcome measure, for use in pediatric and adolescent patients with head and neck cancer (HNC). Methods: To establish content validity (Part 1), between June 2017 and August 2019, cognitive interviews were conducted with survivors of pediatric HNC (n = 15), and input was obtained from clinical experts (n = 21). To examine item and scale performance (Part 2), Rasch Measurement Theory (RMT) analysis was performed using data from two international studies (n = 121). Results: Part 1: Qualitative data from 15 survivors and input from 21 experts provided evidence to support the use of the FACE-Q Craniofacial Module in pediatric HNC. Part 2: The field-test study sample included 121 survivors of pediatric HNC. RMT analysis provided evidence of reliability and validity for 10 FACE-Q scales. Data for each scale fit the RMT model. Scale reliability was high, with Person Separation Index and Cronbach's alpha values ≥0.82 for 9 scales. Mean scores on the Appearance, Psychological, and Social scales were higher for those who liked aspects of their face more. For participants with (vs. without) a facial difference, mean scores were lower for the Face, Jaws, Psychological, and Social scales. Conclusion: The FACE-Q Craniofacial Module evidenced reliability and validity for HNC survivors aged 8-29 years and can be used in research and clinical care to measure quality of life of pediatric survivors with HNC.

Most Efficient and Meaningful Patient-Reported Appearance Assessment in Different Cleft Types and Age Groups with CLEFT-Q.

BACKGROUND: The CLEFT-Q, a questionnaire developed and validated specifically for cleft patients, contains seven appearance scales. The International Consortium of Health Outcomes Measurement (ICHOM) has incorporated only some CLEFT-Q appearance scales in the Standard Set to minimize burden. This study evaluates which appearance scales provide the most meaningful information in the different cleft types at specific ages, for the most efficient cleft appearance outcome assessment. METHODS: Within this international multicenter study, outcomes of the seven appearance scales were collected, either as part of the ICHOM Standard Set, or as part of the field test study performed to validate the CLEFT-Q. Analyses were performed in separate age groups and cleft types, and involved univariate regression analyses, trend analyses, t tests, correlations, and floor and ceiling effects. RESULTS: A total of 3116 patients were included. Scores for most appearance scales showed a downward trend by age group, with the exception of the Teeth and Jaw scales. In all cleft types, several scales correlated strongly with each other. No floor effects were observed, but ceiling effects were found in several scales in different age groups, most often in the CLEFT-Q Jaw scale. CONCLUSIONS: A proposition for the most meaningful and efficient appearance outcome assessment in cleft patients is made. It was composed so that recommendations are of value for different cleft protocols and initiatives. Suggestions for the use of scales in the ICHOM Standard Set at different ages are given, and also from a clinical perspective. Use of the CLEFT-Q Scar, Lips, and Nose scales will provide additional relevant information.

What is the optimal assessment of speech? A multicentre, international evaluation of speech assessment in 2500 patients with a cleft.

OBJECTIVES: Speech problems in patients with a cleft palate are often complex and multifactorial. Finding the optimal way of monitoring these problems is challenging. The International Consortium of Health Outcomes Measurement (ICHOM) has developed a set of standardised outcome measures at specific ages for patients with a cleft lip and/or palate, including measures of speech assessment. This study evaluates the type and timing of speech outcome measures currently included in this ICHOM Standard Set. Additionally, speech assessments in other cleft protocols and initiatives are discussed. DESIGN, SETTING AND PARTICIPANTS: An international, multicentre study was set up including centres from the USA and the Netherlands. Outcomes of clinical measures and Patient Reported Outcome Measures (PROMs) were collected retrospectively according to the ICHOM set. PROM data from a field test of the CLEFT-Q, a questionnaire developed and validated for patients with a cleft, were collected, including participants from countries with all sorts of income statuses, to examine the value of additional moments of measurement that are used in other cleft initiatives.Data from 2500 patients were included. Measured outcomes contained univariate regression analyses, trend analyses, t-tests, correlations and floor and ceiling effects. RESULTS: PROMs correlated low to moderate with clinical outcome measures. Clinical outcome measures correlated low to moderate with each other too. In contrast, two CLEFT-Q Scales correlated strongly with each other. All PROMs and the Percent Consonants Correct (PCC) showed an effect of age. In patients with an isolated cleft palate, a ceiling effect was found in the Intelligibility in Context Scale. CONCLUSION: Recommendations for an optimal speech outcome assessment in cleft patients are made. Measurement moments of different cleft protocols and initiatives are considered in this proposition. Concerning the type of measures, adjustment of the current PCC score outcome seems appropriate. For centres with adequate resources and specific interest in research, translation and validation of an upcoming tool, the Cleft Audit Protocol for Speech Augmented, is recommended.

Determining Construct Validity of a Patient-Reported Outcome Measure for Birthmarks on the Face and Body.

Background: The FACE-Q Craniofacial module includes a scale that measures how bothered an individual is by the appearance of a birthmark on the face or body. Objective: To determine if the Birthmark scale measuring appearance of the birthmark has evidence of construct validity among children and young adults, aged 8-29 years old, with a birthmark on the face or body. Methods: Participants were recruited as part of the field test of the FACE-Q Craniofacial module. Construct validity of the Birthmark scale was examined using a priori hypotheses testing. Results: Two hundred seventy participants were included, who were predominantly female (60.4%) and had a facial birthmark (71.5%). The Birthmark scale correlated (p ≤ 0.01) with scale scores for Face, Appearance Distress, Psychological, School, and Social. Scores for participants with more "noticeable" birthmarks were (p ≤ 0.01) associated with worse Birthmark scale scores. Conclusion: The findings support that the Birthmark scale can be used to measure the patient's perspective of the appearance of their birthmark, providing a means for clinicians to incorporate the patient's view in shared decision-making and research.

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.

Patient-Reported Outcome Measures in Gender-Affirming Surgery.

Patient-reported outcome measures (PROMs) are questionnaires that assess how patients feel and function. PROMs should be developed and validated using a mixed methods, multistep approach with extensive patient input to ensure that they are easy to understand, comprehensive, and relevant. PROMs that are specific to gender-affirming care (including surgery), such as the GENDER-Q, can be used to educate patients, align patients' goals and preferences with realistic expectations about the surgical procedures' purposes and outcomes, and conduct comparative effectiveness research. PROM data can contribute to evidence-based, shared decision making and just access to gender-affirming surgical care.