Rasch Measurement Theory Analysis Research Articles

FACE-Q Craniofacial Module: Part 1 validation of CLEFT-Q scales for use in children and young adults with facial conditions

The CLEFT-Q includes 12 independently functioning scales that measure appearance (face, nose, nostrils, teeth, lips, jaws), health-related quality of life (psychological, social, school, speech distress), and speech function, and an eating/drinking checklist. Previous qualitative research revealed that the CLEFT-Q has content validity in noncleft craniofacial conditions. This study aimed to examine the psychometric performance of the CLEFT-Q in an international sample of patients with a broad range of facial conditions. Data were collected between October 2016 and December 2019 from 2132 patients aged 8 to 29 years with noncleft facial conditions. Rasch measurement theory (RMT) analysis was used to examine Differential Item Function (DIF) by comparing the original CLEFT-Q sample and the new FACE-Q craniofacial sample. Reliability and validity of the scales in a combined cleft and craniofacial sample (n=4743) were examined. DIF was found for 23 CLEFT-Q items when the datasets for the two samples were compared. When items with DIF were split by sample, correlations between the original and split person locations showed that DIF had negligible impact on scale scoring (correlations ≥0.995). In the combined sample, RMT analysis led to the retention of original content for ten CLEFT-Q scales, modification of the Teeth scale, and the addition of an Eating/Drinking scale. Data obtained fit with the Rasch model for 11 scales (exception School, p=0.04). Person Separation Index and Cronbach alpha values met the criteria. The scales described in this study can be used to measure outcomes in children and young adults with cleft and noncleft craniofacial conditions.

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

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 scoresand BMI (r= -0.249, P < 0.001). The new BODY-Q scales can be used in research and clinical practice to assess weight loss treatments from the patient perspective.

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

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

Psychometric Validation of the FACE-Q Craniofacial Module for Facial Nerve Paralysis

Background: Systematic reviews have identified the need for a patient-reported outcome measure for facial nerve paralysis (FNP). The aim of this study was to determine the psychometric properties of FACE-Q Craniofacial module scales when used in a combined sample of children and older adults with FNP. Methods: Data were collected between December 2016 and December 2019. We conducted qualitative interviews with children and adults with FNP. FACE-Q data were collected from patients aged 8 years and older with FNP. Rasch measurement theory analysis was used to examine the reliability and validity of the relevant scales in the FNP sample. Results: Twenty-five patients provided 2052 qualitative codes related to appearance, physical, psychological, and social function. Many patient concerns were common across age. The field-test sample included 235 patients aged 8-81 years. Of the 13 scales examined, all 122 items had ordered thresholds and good item fit to the Rasch model. For 12 scales, person separation index values were ≥0.79 and Cronbach's alpha values were ≥0.82. The 13th scale's reliability values were ≥0.71. Conclusion: The FACE-Q Craniofacial module scales described in this study can be used to collect and compare evidence-based outcome data from children and adults with FNP.

FACE-Q craniofacial module: Part 2 Psychometric properties of newly developed scales for children and young adults with facial conditions

The FACE-Q Craniofacial Module is a patient-reported outcome measure designed for patients aged 8 to 29 years with conditions associated with a facial difference. In part 1, we describe the psychometric findings for the original CLEFT-Q scales tested in patients with cleft and noncleft facial conditions. The aim of this study was to examine psychometric performance of new FACE-Q Craniofacial Module scales. Data were collected between December 2016 and December 2019 from patients aged 8 to 29 years with conditions associated with a visible or functional facial difference. Rasch measurement theory (RMT) analysis was used to examine psychometric properties of each scale. Scores were transformed from 0 (worst) to 100 (best) for tests of construct validity. 1495 participants were recruited with a broad range of conditions (e.g., birthmarks, facial paralysis, craniosynostosis, craniofacial microsomia, etc.) RMT analysis resulted in the refinement of 7 appearance scales (Birthmark, Cheeks, Chin, Eyes, Forehead, Head Shape, Smile), two function scales (Breathing, Facial), and an Appearance Distress scale. Person separation index and Cronbach alpha values met criteria. Three checklists were also formed (Eye Function, and Eye and Face Adverse Effects). Significantly lower scores on eight of nine scales were reported by participants whose appearance or functional difference was rated as a major rather than minor or no difference. Higher appearance distress correlated with lower appearance scale scores. The FACE-Q Craniofacial Module scales can be used to collect and compare patient reported outcomes data in children and young adults with a facial condition.

International study to develop the WOUND‐Q patient‐reported outcome measure for all types of chronic wounds

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.

Development and Psychometric Validation of the BREAST-Q Animation Deformity Scale for WomenUndergoing an Implant-Based Breast Reconstruction After Mastectomy.

To assess the impact of animation deformity on health-related quality of life, a content-specific, valid, and reliable patient-reported outcome measure is needed. This report describes the development and validation of the BREAST-Q Animation Deformity scale. Women with breast cancer who had an implant-based reconstruction provided data. In phase 1 (January 2017 and December 2018), qualitive and cognitive patient interviews and expert input were used to develop and refine scale content. In phase 2 (March to June 2019), a fieldtest study with members of the Love Research Army (LRA) was conducted. Rasch Measurement Theory (RMT) analysis was used to examine psychometric properties. In phase 1 of the study, qualitative (n = 11) and cognitive (n = 4) interview data and expert input (n = 9) led to the development of a 12-item scale measuring animation deformity. In phase 2, 651 LRA members provided data and 349 participated in a test-retest study. In the RMT analysis, the data fit the Rasch model (X2(96) = 104.06; p = 0.27). Thescale's reliability was high, with person separation index and Cronbach alpha values with/without extremes of≥ 0.84 and ≥ 0.92 respectively, and anintraclass correlation coefficient of 0.92 (95%confidence interval,0.90-0.94). Mean scores on the Animation Deformity scalevaried as predicted across subgroups of participants who reported differing amounts of change in breast appearance when theirarms were lifted overhead or when they liftedsomething heavy, and for increasing happiness with the overall outcome of theirbreast reconstruction. The 12-item Animation Deformity scale forms a new scale in the BREAST-Q Reconstruction Module that can be used in comparative effectiveness research or to inform clinical care.

An international study to develop the EAR-Q patient-reported outcome measure for children and young adults with ear conditions

There is currently a lack of patient-reported outcome measures for ear reconstruction. We developed the EAR-Q to measure ear appearance and post-operative adverse effects from the patient perspective. Field-test data were collected from children and young adults in eight countries between 13 May 2016 and 12 December 2019. Rasch measurement theory (RMT) analysis was used to refine the scales and to examine their psychometric properties. Participants had microtia (n = 607), prominent ears (n = 145) or another ear condition (n = 111), and provided 960 assessments for the Appearance scale (e.g., size, shape, photos), and 137 assessments for the Adverse Effects scale (e.g., itchy, painful, numb). RMT analysis led to the reduction of each scale to 10-items. Data fit the Rasch model for the Appearance (X2(80) = 90.9, p = 0.19) and Adverse Effects (X2(20) = 24.5, p = 0.22) scales. All items in each scale had ordered thresholds and good item fit. There was no evidence of differential item function for the Appearance scale by age, gender, language, or type of ear condition. Reliability was high for the Appearance scale, with person separation index (PSI) and Cronbach alpha values with and without extremes ≥0.92. Reliability for the Adverse Effects scale was adequate (i.e., PSI and Cronbach alpha values ≥0.71). Higher scores (liked appearance more) correlated with higher scores (better) on Psychological, Social and School scales. The EAR-Q can be used in those 8-29 years of age to understand the patient perspective in clinical practice and research, and in addition, can be used to benchmark outcomes for ear reconstruction internationally.

Structural validity of the Boston Carpal Tunnel Questionnaire and its short version, the 6-Item CTS symptoms scale: a Rasch analysis one year after surgery

BackgroundThe Boston Carpal Tunnel Questionnaire (BCTQ) and its shorter version, the Six-Item Carpal Tunnel Symptoms Scale (CTS-6), are widely used for assessing function and/or symptoms in patients with carpal tunnel syndrome. This study examined the structural validity of the BCTQ and CTS-6 among patients who had undergone surgery for treatment of carpal tunnel syndrome.MethodsThe data for this cross-sectional analysis were obtained from 217 adult patients who had undergone carpal tunnel release surgery 1 year earlier. All patients completed the CTS-6, Symptom Severity Scale (SSS) and Functional Status Scale (FSS) of the BCTQ at 12 months after surgery. The Rasch Measurement Theory (RMT) was applied to investigate the unidimensionality, residual correlation, differential item functioning, scale coverage/targeting, and person separation of the CTS-6, SSS and FSS of the BCTQ.ResultsThe FSS showed unidimensionality and good scale and item fit. All items showed ordered response category thresholds. Eight of the FSS items displayed differential item functioning favoring age or gender. The multidimensional structure of the CTS-6 was absorbed by creating a testlet for frequency of symptoms or testlets for pain and numbness. The testlets supported unidimensionality in the BCTQ SSS. One item in the CTS-6 and two items in the BCTQ SSS showed differential item functioning favoring age or gender. Four items in the BCTQ SSS and two items in the CTS-6 exhibited disordered response category thresholds. Merging of the relevant response categories led to ordered response category thresholds. The person separation indices were 0.73, 0.86 and 0.77 for the CTS-6, BCTQ SSS and FSS, respectively.ConclusionsBased on the RMT analysis, the CTS-6 has superior psychometric properties compared to the BCTQ SSS in surgically treated patients. The CTS-6 might be more accurate when separated into item sets measuring pain or numbness. The FSS of the BCTQ has acceptable construct validity, although gender differences at some ages were observed in responses.

The BODY-Q Chest Module: Further Validation in a Canadian Chest Masculinization Surgery Sample.

The BODY-Q Chest module is a patient-reported outcome (PRO) instrument that measures satisfaction with how the chest (10 items) and nipples (5 items) look. This PRO instrument was previously field tested in an international sample of people seeking treatment for gynecomastia (n = 174), weight loss (n = 224), and chest masculinization (n = 341). The aim of this study was to examine the psychometric performance of the BODY-Q Chest module in a new chest masculinization surgery sample. Data were collected from patients attending a private plastic surgery outpatient clinic in Canada between January 2018 and June 2019. Rasch measurement theory analysis was used to examine how the scales performed psychometrically. The sample provided 266 assessments (115 preoperative, 151 postoperative). All items had ordered thresholds, providing evidence that the 4 response options for each scale worked as expected. Item fit was within ±2.5 for all items, with all Bonferroni adjusted chi-square values nonsignificant. The data for the chest (χ2(20) = 18.72, P = 0.54) and nipples (χ 2(10) = 12.28, P = 0.27) scales fit the requirements of the Rasch model. Reliability was high with person separation index and Cronbach's α values of ≥0.95 for the chest and ≥0.87 for the nipple scales, respectively. More depressive symptoms on the Patient Health Questionnaire-9 and lower health-related quality of life scales were weakly correlated with worse scores on the chest and nipple scales (P < 0.001). The BODY-Q Chest module was shown to be scientifically sound in an independent sample of patients seeking chest masculinization surgery.

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

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. The authors sought to develop and field test a new BODY-Q cellulite scale to measure the appearance of cellulite. 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. 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. 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.

International mixed methods study protocol to develop a patient-reported outcome measure for all types of chronic wounds (the WOUND-Q)

IntroductionMost patient-reported outcome measures (PROM) for chronic wounds are specific to a single wound type (eg, pressure ulcer) or part of the body. A barrier to outcome assessment in wound...

Development and Validation of the BREAST-Q Breast-Conserving Therapy Module.

In breast cancer surgery, patient-reported outcome measures are needed to measure outcomes best reported by patients (e.g., psychosocial well-being). This study aimed to develop and validate a new BREAST-Q module to address the unique concerns of patients undergoing breast-conserving therapy (BCT). Phase 1 involved qualitative and cognitive interviews with women who had BCT and clinical expert input to establish content for the BCT module. A field-test (phase 2) was performed, and Rasch measurement theory (RMT) analysis was used for item reduction and examination of reliability and validity. Validation of the item-reduced scales in a clinical sample (phase 3) was conducted for further assessment of their psychometric properties. Qualitative interviews with 24 women resulted in the addition of 15 new items across multiple existing BREAST-Q scales and the development of two new scales (Adverse Effects of Radiation and Satisfaction With Information-Radiation Therapy). Feedback from 15 patients and 5 clinical experts were used to refine the instructions, response options, and item wording. An RMT analysis of data from 3497 women resulted in item reduction. The final set of scales showed evidence of ordered response option thresholds, good item fit, and good reliability, except for the Adverse Effects of the Radiation Scale. Validity and reliability were further supported by the phase 3 data from 3125 women. The BREAST-Q BCT module can be used in research and clinical care to evaluate quality metrics and to compare surgical outcomes across all breast cancer surgery patients.

Development of a new patient-reported outcome measure to evaluate treatments for acne and acne scarring: the ACNE-Q.

Psychosocial concerns represent important outcomes in studies of treatments for acne and acne scarring. Also important, but largely overlooked, is the concept of appearance. To design an acne-specific patient-reported outcome measure for acne and acne scarring. We used a mixed-methods approach. Phase I involved 21 patient interviews that were audio-recorded, transcribed and coded. Concepts were identified and developed into scales that were refined through 10 cognitive interviews and input from 16 clinical experts. Phase II involved data collection at hospital and community-based dermatology clinics in Canada and the U.S.A. Eligible participants were aged 12 years and older with acne and/or acne scars on the face, chest and/or back. Rasch Measurement Theory (RMT) analyses were performed to examine psychometric properties. Phase I led to the development of seven scales that measure appearance of facial skin, acne (face, chest and back) and acne scars, acne-specific symptoms and appearance-related distress. In phase II, 256 patients completed the ACNE-Q. RMT analysis provided evidence that the items of each scale worked together conceptually and statistically. Most participants scored within the range of measurement for each scale (81·9-93·1%). Reliability was high, with person separation index values and Cronbach alpha values > 0·90 for the appearance scales, ≥ 0·87 for appearance-related distress and ≥ 0·75 for symptoms. Worse scores on appearance scales correlated with worse symptom scores and more appearance-related distress. The ACNE-Q is a rigorously developed instrument that can be used to measure appearance and other patient-centred concerns. What's already known about this topic? Acne is a common dermatological condition that can have an important impact on psychosocial function. Current patient-reported outcome measures specific to acne focus mostly on measuring psychological and social impact. What does this study add? The ACNE-Q provides a set of independently functioning scales that measure appearance of facial, back and chest acne, acne scarring and facial skin. Additional scales measure appearance-related distress and acne symptoms. What are the clinical implications of this work? ACNE-Q provides the dermatology community with a rigorously developed patient-reported measure for acne that can be applied in clinical trials, research and patient care. The measurement of appearance by ACNE-Q scales is more comprehensive than in other instruments providing important information on appearance of their acne and/or acne scars from the patient perspective.

Development and Psychometric Evaluation of the Cancer Distress Scales for Adolescent and Young Adults.

Purpose: The use of valid and reliable screening tools to measure distress may help to identify adolescent and young adults (AYA) with cancer who need additional support. Our study describes a two-phase approach to adapt the Australian AYA oncology and survivorship distress screening tools for use in Canada. Methods: Phase 1 involved refining the Australian AYA oncology and survivorship screening tools using cognitive interviews with AYA with cancer and feedback from experts. In phase 2, a field-test study was performed, and Rasch Measurement Theory (RMT) analysis was used for item reduction and to examine reliability and validity. Results: Cognitive interviews with 45 AYA with cancer and feedback from 25 experts resulted in a field-test version of the Cancer Distress Scales for AYA (CDS-AYA) consisting of 91 items that measure 9 constructs. The field-test sample included 515 participants. RMT analysis identified five scales (impact of cancer, physical, emotional, cancer worry, and cognitive) with ordered thresholds, good item fit (-3.70 to 2.82), and acceptable reliability (0.85-0.94). Reliability for the remaining four scales (employment, education, practical, and social) was low, and the scales were retained as checklists, with the exception of the social scale that was dropped. Conclusion: The final item-reduced CDS-AYA consist of 48 items in 5 scales, with 2 stand-alone items in the physical and emotional scales and 23 items in 3 checklists. The CDS-AYA can be used in research and in clinical practice to measure distress in AYA with cancer.

Does the MDS-UPDRS provide the precision to assess progression in early Parkinson\u2019s disease? Learnings from the Parkinson\u2019s progression marker initiative cohort

ObjectivesDeveloping disease modifying therapies for Parkinson’s disease (PD) calls for outcome measurement strategies focused on characterizing early stage disease progression. We explored the psychometric evidence for using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part II (patient motor experience of daily living) and part III (clinician motor examination) in this context.MethodsMDS-UPDRS-II and -III data were collected at screening, month 12, and month 24 from 384 early stage PD patients (diagnosis ≤ 2 years; Hoehn and Yahr stage 1/2) in the Parkinson’s Progression Markers Initiative (PPMI) study. Psychometric analysis, based on Rasch measurement theory (RMT), was performed on both the original MDS UPDRS-II and -III scales and exploratory content-driven scale structures.ResultsRMT analyses showed neither scale was well targeted to early PD. A marked floor effect appeared for most items and a clear item gap was consistently observed in very mild severity of motor signs and levels of motor impact. The original MDS-UPDRS-II and -III scales also displayed disordered thresholds (9/13 and 20/33 items, respectively), indicating response scales not functioning as expected, and misfit (5/13 and 12/33 items, respectively), flagging areas for potential improvement.ConclusionsThe MDS-UPDRS-II and -III have psychometric limitations which limits the precision of measurement of motor symptoms and impact in early PD. This can lead to insensitivity in detecting differences and clinical change. Importantly, the diagnostic psychometric evidence provided by the RMT analysis provides a clear starting point for how to improve the quantification of clinically relevant concepts to characterize the course of early PD.

Abstract 94: SCAR-Q: International Results and Why Individuals Report the Need for Scar Revision Surgery

PURPOSE: Millions of scars are formed annually with wide-ranging effects on the quality of life of the individual. Currently, there is no internationally validated, rigorously tested PRO measure (‘PROM’) that can be used to assess scar outcomes of all major etiologies in both children and adults. Nor, do we currently understand why patients may seek scar revision surgery. The purpose of this study is to describe the international field-test of seven clinics in four countries, the psychometric properties of the PROM, and the independent risk factors of patients requiring scar revision surgery. METHODS: Between March, 2017 and April, 2018 data were collected from 7 outpatient clinics in New Zealand, Chile, Canada, and the USA. Participants completed a questionnaire booklet with demographic and clinical questions as well as the preliminary SCAR-Q (Appearance, Symptom, and Psychosocial Impact). Rasch Measurement Theory (RMT) analysis was conducted examining item response options, item fit statistics, dependency, targeting, stability, and person separation index. In addition, Cronbach’s alpha and intraclass correlation coefficient were completed to examine reliability. In addition, a multivariable regression analysis was completed to examine independent risk factors for patients self-reporting the need for scar revision surgery. RESULTS: 773 patients were consented and 731 patients completed the survey results in full. Participants were aged 8–88 years with predominantly surgical scars (n=354, 48.4%), traumatic (n=199, 27.2%), and burn scars (n=184, 25.1%). Analysis led to the refinement of the SCAR-Q scales: Appearance, Symptoms, and Psychosocial Impact from 48 items to the final 29 items. RMT analysis showed ordered thresholds for response options, 25 items had fit residuals within the required range, and residual correlations were found only with one pair of items. Reliability was high, with Person Separation Index values of 0.90, 0.82, 0.84, Cronbach alpha values 0.96, 0.91, 0.95 and Intraclass Correlation Coefficient values of 0.92, 0.94. 0.88 respectively. Finally, having a health condition (OR 2.032; 0.944, 4.370), perceiving that one scars badly (OR 2.631, 1.195–5.792), a prior scar revision surgery (0.253; 0.127–0.672), and scoring poorly on the SCAR-Q Psychosocial Impact scale (OR 0.339; 0.171–0.672) were independent risk factors for reporting the need for future scar revision surgery. CONCLUSION: This RMT analysis showed that the 3 SCAR-Q scales performed well in this international, field-test sample, with good to excellent reliability. The SCAR-Q represents a rigorously developed PROM that can be used to evaluate scars in research, clinical care, and quality improvement initiatives. In addition, this study suggests that patients with the listed independent risk factors may require heightened attention and clinical care. These individuals may require more scar symptom management, psychosocial support in the case of social work or in severe cases a psychiatry referral, and/or scar treatment to help alleviate their appearance related concerns.

52 SCAR-Q, A Patient-Reported Outcome Measure for Scars, Field-Test of Individuals with Burn Scars

As mortality rates of burn survivors continues to decrease, burn surgeons are facing more complex reconstructive challenges and need a systematic way to elicit patient input about their scars. Burn scars are especially difficult to treat as the vast majority will develop hypertrophic scars, which are more symptomatic and lead to increased functional and cosmetic disabilities. A comprehensive scar-specific PROM for the burn, surgical, and traumatic scar populations was field-tested worldwide. Our aim is to describe the field-test findings specific for the burn population and the overall Rasch Measurement Theory (RMT) analysis. A preliminary PROM, the SCAR-Q, was developed from a secondary analysis of 244 qualitative interviews, 45 cognitive interviews, and feedback from 27 clinical experts worldwide to encompass three scales: Appearance, Symptoms, and Psychosocial Impact. SCAR-Q was field-tested in 4 burn-specific clinics worldwide. RMT was used to analyze its psychometric properties and to further refine it of the overall sample. Of the 731 participants who filled out the SCAR-Q booklet, a total of 184 burn survivors completed the SCAR-Q study booklet. The majority were adults(87,47%), individuals with flame burns(97,53%), immature scars(92,50%), normal scar type(96,52%), spanning multiple anatomic locations(average 3.1+/12.9). The RMT findings are on the overall sample. RMT analysis decreased the number of items from 48 to 29 due to poor item fit, disordered thresholds, and/or redundancy. No DIF was found based on scar etiology suggesting items worked the same across all scar etiologies. Person separation indexes were above 0.80 (with extremes) and 0.79 (without extremes). Cronbach’s alpha values were 0.91 and higher, and the intraclass correlation coefficients were 0.88 and above. Lower mean scores were associated with burn scars on all three SCAR-Q scales. With surgical evaluations becoming more person-centered, a PROM specific to scars is essential to adequately capture patient concerns and the impact of interventions on their lives. The SCAR-Q can be used in the burn scar population. We anticipate that SCAR-Q will be used to determine the crucial timing for scar modulation, evaluate outcomes in scar therapies, aid in clinical trials, and be part of quality improvement initiatives.

Development of the BODY-Q Chest Module Evaluating Outcomes following Chest Contouring Surgery.

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. 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. 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. 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.

Leveraging patient-reported outcomes data to inform oncology clinical decision making: Introducing the FACE-Q Head and Neck Cancer Module.

Existing patient-reported outcome measures (PROMs) used to assess patients with head and neck cancer have methodologic and content deficiencies. Herein, the development of a PROM that meets a range of clinical and research needs across head and neck oncology is described. After development of the conceptual framework, which involved a literature review, semistructured patient interviews, and expert input, patients with head and neck cancer who were treated at Memorial Sloan Kettering Cancer Center were recruited by their surgeon. The FACE-Q Head and Neck Cancer Module was completed by patients in the clinic or was sent by mail. Rasch measurement theory analysis was used for item selection for final scale development and to examine reliability and validity. Scale scores for surgical defect and adjuvant therapy were compared with the cohort average to assess clinical applicability. The sample consisted of 219 patients who completed the draft scales. Fourteen independently functioning scales were analyzed. Item fit was good for all 102 items, and all items had ordered thresholds. Scale reliability was acceptable (person separation index was >0.75 for all scales; Cronbach α values were >.87 for all scales; test-retest ranged from 0.86 to 0.96). The scales performed well in a clinically predictable way, demonstrating functional and psychosocial differences across disease sites and with adjuvant therapy. The scales forming the FACE-Q Head and Neck Cancer Module were found to be clinically relevant and scientifically sound. This new PROM now is validated and ready for use in research and clinical care.