The WOUND-Q Function and Symptoms Scales for Chronic Lower Extremity Wounds: A Validation study.

OBJECTIVE: Determine the validity and reliability of the LIMB-Q scales, Function and Symptoms, in patients with chronic lower extremity wounds. APPROACH: Cognitive debriefing interviews with people with current or previous wounds were conducted to examine content validity. Scales were field-tested in an international sample of people with chronic lower extremity wounds sourced from an online platform (i.e., Prolific). Psychometric properties were examined using Rasch Measurement Theory analysis. A test-retest reproducibility study was performed, and construct validity examined. RESULTS: Content validity was established after 10 cognitive interviews. A total of 233 people with lower extremity wounds (age 19-80 years, mean 39.3) participated in the field-test. All 25 items tested demonstrated good fit to the Rasch model with ordered thresholds. One item had a fit residual outside ± 2.5, but no items had significant χ2 values after Bonferroni adjustment. Reliability was high with Person Separation Index, Cronbach alpha, and intraclass correlation coefficients values >0.8. Strong correlations were found between the Function and Symptoms scales and EQ-5D dimensions measuring similar constructs as well as the EQ-5D global score. All hypothesis for construct validity were confirmed. INNOVATION: PROMs are an important component of patient-centered care, as they capture the patient's perspective in a rigorous and reproducible way. Adding these two scales to the WOUND-Q provides a means to measure function and symptoms associated with lower extremity wounds. CONCLUSION: These new WOUND-Q scales can be used to measure outcomes important to patients with lower extremity wounds in clinical settings and research studies.

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.

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.

Further psychometric evaluation of the WOUND-Q: A responsiveness study.

The WOUND-Q is a modular patient-reported outcome measure (PROM) with 13 scales measuring constructs across 4 domains (i.e., wound characteristics, health related quality of life, experience of care and wound treatment). The psychometrics of the WOUND-Q were previously assessed and the 13 scales evidenced good validity and reliability. However, the responsiveness (i.e., ability to detect clinical change) of the WOUND-Q has yet to be assessed. The objective of this study was to evaluate responsiveness for 9 WOUND-Q scales that assess outcomes, in a sample of people 18 years of age or older with chronic wounds that were present for at least 3 months. This study conducted a 4 month follow-up of 421 participants who completed the WOUND-Q as part of a previous psychometric study. Participants completed an online survey answering questions about their current wound state (e.g., number, type, size, smell, drainage), anchor questions about change, as well as the WOUND-Q scales that they had completed in their initial assessment. Pre-defined hypotheses were tested with a 75% acceptance threshold indicating sufficient evidence of responsiveness. Minimally important differences (MIDs) were also calculated using both anchor-based and distribution-based methods. Of 390 invited participants, 320 provided responses, ranging in age from 19 to 84 years. Acceptance of hypotheses ranged from 60% to 100%, with only the Symptom scale not meeting the 75% threshold. The findings of this study provide evidence that the WOUND-Q can validly measure clinical change in patients with chronic wounds.

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.

"I Want 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 under-studied area. We added scales to FACE-Q Aesthetics to provide a means to measure this concept from the patient's perspective. OBJECTIVES: To develop and validate FACE-Q natural scales. METHODS: Concept elicitation interviews with people having minimally invasive treatments were conducted to explore the natural concept and develop scales. Patient and expert input was used to refine scale content. An online sample (i.e., Prolific) of people who had a facial aesthetic treatment to examine psychometric properties using Rasch Measurement Theory analysis. A test-retest reliability study was performed, and construct validity 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 coefficients 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 wanting a more 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. CONCLUSIONS: Many people seeking facial aesthetic treatments want to look natural. 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.

Factors Associated With Adolescent and Young Adult Females Attending a Fertility Consultation Within 30 Days of a Cancer Diagnosis in Ontario, Canada.

Purpose: To examine the factors associated with females attending a fertility consultation within 30 days of cancer diagnosis. Methods: This is a retrospective cohort study, including females, 15 to 39 years of age, diagnosed with cancer in Ontario, Canada. Administrative data were used from the Institute of Clinical and Evaluative Sciences for the period 2006 to 2019. A backward selection multivariate logistic regression was performed, with a primary outcome of fertility consultation within 30 days of diagnosis. Results: A total of 20,556 females were included in the study, with 7% having attended a fertility visit within 30 days of diagnosis. Factors associated with being more likely to attend included: not currently having children (odds ratio [OR] = 4.3; confidence interval [95% CI 3.6-5.1]), later years of diagnosis (OR = 3.2; 95% CI [2.8-3.8]), having undergone chemotherapy (OR = 3.6; 95% CI [3.0-4.3]) or radiation therapy (OR = 1.9; 95% CI [1.6-2.2]), and less marginalization within dependency quintiles (OR 1.4; 95% CI [1.1-1.7]). Having a cancer with lower risk to fertility (OR = 0.3; 95% CI [0.2-0.3]), death within a year of diagnosis (OR = 0.4; 95% CI [0.3-0.6]), and residing in a northern region of Ontario (OR = 0.3; 95% CI [0.2-0.4]) were associated with being less likely to attend. For sociodemographic factors, lower levels of income (OR = 0.5; 95% CI [0.4-0.6]) and marginalization with residential instability (OR = 0.6; 95% CI [0.5-0.8]) were associated with being less likely to attend a fertility consultation. Conclusions: Rates for attendance of female fertility consultations after a cancer diagnosis remain low, with disparities by both clinical and demographic factors.

Further psychometric validation and test-retest reproducibility of the WOUND-Q.

WOUND-Q is a condition-specific patient-reported outcome measure developed for all types of chronic wounds, located anywhere on the body. To establish reliability and validity of a patient-reported outcome measure, multiple pieces of evidence are required. The purpose of this study was to examine the measurement properties of 9 of the 13 WOUND-Q scales and perform a test-retest reproducibility study in an international sample. In August 2022, we invited members of an international online community (Prolific.com) with any type of chronic wound to complete a survey containing the WOUND-Q scales, the Wound-QoL and EQ-5D. A test-retest survey was performed 7 days after the first survey. It was possible to examine the reliability and validity of eight of the nine WOUND-Q scales by Rasch Measurement Theory (RMT). To examine test-retest reproducibility intraclass correlation coefficients (ICCs), the standard error of the measurement and the smallest detectable change were calculated. In total, 421 patients from 22 different countries with 11 different types of chronic wounds took part in this study. Our analyses provided further evidence of the reliability and validity of the scales measuring wound characteristics (assessment, drainage, smell), health-related quality of life (life impact, psychological, sleep, social) and wound treatment (dressing).

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.

Development and Validation of a Patient-Reported Outcome Measure for Fingernail and Toenail Conditions: The NAIL-Q.

Background: Patient-reported outcome measures (PROMs) are needed to measure outcomes that matter to people with nail conditions, from their perspective. Objective: To design a comprehensive new PROM (NAIL-Q) to measure outcomes important in toenail and fingernail conditions. Methods: A mixed methods iterative approach was used. Phase 1 involved concept elicitation interviews that were audio-recorded, transcribed, and coded line-by-line. Concepts were developed into scales and refined through cognitive debriefing interviews with patients and expert input. Data was then collected from an international sample using a crowdsource platform. Eligible participants were aged ≥18 years with a nail condition for at least 3 months. Rasch Measurement Theory (RMT) analysis was used to examine item and scale performance. Other psychometric tests included test-retest reliability, and convergent and construct validity. Results: Phase 1 interviews involved 23 patients with 10 nail conditions and input from 11 dermatologists. The analysis led to the development of 84 items for field-testing. In Phase 2, 555 participants completed the survey. Toenail conditions (n = 441) were more common than fingernail conditions (n = 186). The RMT analysis reduced the number of items tested to 45 in 7 scales measuring nail appearance, health-related quality of life concerns, and treatment outcomes. All items had ordered thresholds and nonsignificant chi-square p values. Reliability statistics with and without extremes for the Person Separation Index were ≥0.79 and Cronbach's alpha were ≥0.83, and for intraclass correlation coefficients were ≥0.81. Construct validity was further supported in that most participants agreed that the NAIL-Q was easy to understand, asked relevant and important questions in a respectful way, and that it should be used to inform clinical care. Conclusion: The NAIL-Q is a rigorously designed and tested PROM that measures nail appearance, health-related quality of life and treatment outcomes. This PROM can be used in clinical practice to inform patient care and to include the patient perspective in research.

Development and Validation of an Indicator for Oncofertility Care in Ontario, Canada, for Adolescents and Young Adults with Cancer.

Introduction: There is a lack of metrics to monitor and evaluate fertility care in adolescents and young adults with cancer. This study evaluated the indicator "proportion of cases attending a fertility consult visit ≤30 days from diagnosis of cancer" using the National Quality Forum (NQF) criteria. Methods: This was a retrospective cohort study using administrative data available through the Institute of Clinical Evaluative Sciences in Ontario, Canada. Cases were included if they were diagnosed with a cancer between January 2005 and December 2019, and aged 15-39 years. Fertility consultations were identified by Ontario Health Insurance Plan Claims Database (OHIP) diagnostic codes 628 and 606.Validity was assessed by examining expected differences in the proportion of fertility consults within clinical and demographic factors using chi-square tests. Reliability was assessed by comparing fertility consult visits identified using OHIP diagnostic codes with consults identified using visits to physicians in a registered specialty, using Pearson's correlation coefficient. Results: The population was composed of 39,977 cases, with 6524 (16.3%) having attended a fertility consult. For diagnostic years 2016-2019, differences in the proportion of cases receiving their first fertility consult within 30 days of diagnosis were observed for sex, age, cancer type, hospital type, Local Health Integration Unit, and region (p < 0.001). There was no correlation between the time from diagnosis to fertility consult and time from diagnosis to the first visit to a fertility-related specialty (r = 0.11; p = 0.002). Conclusion: The indicator examined in this article adhered to the criteria described by the NQF, providing a possible metric for reporting on oncofertility care.

Health state utility values in patients undergoing chest masculinization surgery.

BACKGROUND: Chest masculinization surgery is the most common gender-affirming procedure performed in transgender and gender-diverse individuals. While evidence on the health-related quality of life (HRQL) impact of chest masculinization is starting to emerge, data on health state utility values (HSUVs) associated with the surgery is largely missing. The objectives of this study were to estimate the HSUVs using EQ-5D for patients seeking chest masculinization surgery and assess the determinants of EQ-5D score at 6 months postoperatively. METHODS: Patients seeking chest masculinization at a single community plastic surgery clinic by 2 surgeons completed 3 patient-reported outcome measures - EQ-5D-3L, Patient Health Questionnaire (PHQ)-9, and BODY-Q Chest module - preoperatively and postoperatively at 6 weeks and 6-months. Friedman test was used to assess the differences in PROM scores at the 3 timepoints. Simple and backward stepwise regression analyses of 6-month postoperative EQ-5D scores were performed. RESULTS: A total of 113 patients (mean [SD] age, 25.7 [6.9] years) were included. The mean [SD] EQ-5D scores at preoperative, postoperative 6 weeks and 6 months were 0.81 [0.15], 0.84 [0.15] and 0.87 [0.12], respectively. Postoperatively, problems were most frequently reported in the dimensions "pain/discomfort" and "anxiety/depression". Preoperative PHQ-9 score was a predictor of 6-month postoperative EQ-5D scores following simple (p < 0.01) and backward stepwise linear regression analysis (p < 0.01). CONCLUSION: Chest masculinization was associated with an improvement in overall HRL at 6 months postoperatively; however, this did not achieve statistical significance. Preoperative depression severity was a significant determinant of postoperative HRL. Consequently, additional support must be offered to patients who have a higher level of preoperative depression.

Body Contouring Surgery Improves Long-Term Satisfaction with Appearance and Health-Related Quality of Life after Bariatric Surgery.

BACKGROUND: Patient-reported outcomes are crucial in bariatric surgery (BaS) and body contouring surgery (BC) because patients' goals include improvement in appearance and health-related quality of life (HR-QOL). The BODY-Q is a patient-reported outcome measure developed to measure change in satisfaction with appearance and HR-QOL in BaS and BC patients. The aim of this study was to examine BODY-Q scores over the entire weight loss journey, and to investigate the impact of BC after BaS. METHODS: Patients completed the BODY-Q before and after BaS and BC at four hospital departments in Denmark between 2015 and 2019. Cross-sectional scores were analyzed by phase of weight loss journey using one-way analysis of variance. Scores for patients who provided longitudinal assessments were analyzed using repeated measures analysis of variance and paired t test. The impact of BC was examined over time after BaS, using an independent t test from before BaS through more than 7 years after BaS. RESULTS: The study included 1527 patients who provided 2285 BODY-Q assessments. The cross-sectional analysis by phase of weight loss journey showed higher scores after BaS, lower scores before BC, and highest-level scores after BC. The longitudinal analysis showed higher postoperative mean scores compared with preoperative scores for both BaS and BC. The analysis over time after BaS revealed lower mean scores in patients who did not receive BC. CONCLUSION: The authors' results provide evidence of the positive impact of BaS and BC on patients' lives and emphasize the importance of considering BC to finalize the weight loss journey, as it helps to maintain improvements in appearance and HR-QOL. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Impact of Completing FACE-Q Craniofacial Module Scales on Children and Young Adults with Facial Differences: An International Study.

BACKGROUND: The FACE-Q Craniofacial Module measures outcomes that matter to patients with diverse craniofacial conditions. However, it is not known whether completing a patient-reported outcome measure (PROM) has a negative impact on patients, particularly children. This study aims to investigate the impact of completing the FACE-Q Craniofacial Module and identify factors associated with a negative impact. METHODS: Participants were between 8 and 29 years of age, had a facial difference, and completed at least one module of the FACE-Q Craniofacial Module as part of the international field-test study between December of 2016 and 2019. Participants were asked three questions: "Did you like or dislike answering this questionnaire?" "Did answering these questions change how you feel about how you look?" and "Did answering this questionnaire make you feel unhappy or happy?" Univariate and multivariable logistic regression analyses were used to evaluate variables associated with a negative response. RESULTS: The sample included 927 participants. Most patients responded neutrally to all impact questions: 42.7% neither disliked nor liked the questionnaire; 76.6% felt the same about how they looked; and 72.7% felt neither unhappy nor happy after completion. Negative responses represented a small proportion of patients across all three impact questions (<13.2%). Increased craniofacial severity, more scales completed, and lower scores on all FACE-Q scales were associated with negative responses for all three impact questions ( P <0.01). CONCLUSIONS: This study provides evidence that the FACE-Q Craniofacial Module is acceptable for most participants. Clinicians and study investigators should follow up with patients after completing this PROM to address areas of concern in scale scores. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Psychometric Validation of the CLEFT-Q Patient Reported Outcome Measure: A Prospective Study to Examine Cross-Sectional Construct Validity.

OBJECTIVE: CLEFT-Q is a condition-specific patient-reported outcome measure (PROM) for patients with cleft lip and/or palate (CL/P). The aim of this study was to examine the cross-sectional construct validity of the CLEFT-Q scales. DESIGN: Construct validity was assessed through a prospective study that tested hypotheses regarding correlations of scores with other PROMs that measure related constructs. SETTING: Seven cleft centres in Canada, the USA, and UK were involved. PATIENTS/PARTICIPANTS: Patients were aged eight to 29 years with CL/P. INTERVENTIONS: Before undergoing rhinoplasty, orthognathic, cleft lip scar revision, and alveolar bone graft, participants were asked to complete the following PROMs: CLEFT-Q (9 scales), Child Oral Health Impact Profile (socio-emotional subscale) and Cleft Hearing Appearance and Speech Questionnaire (features 1 subscale). MAIN OUTCOME MEASURE(S): The correlation coefficients examining the relationship between the scales were the main outcome measures. Correlations (Spearman) were calculated and interpreted as follows: <0.3 weak, 0.30 to 0.50 moderate, ≥0.50 strong. RESULTS: Participants (n = 177) were mostly male (61%) and aged between eight and 11 years (42%). Overall, 38 of 52 (73%) hypotheses tested were supported. More specifically, 20 of 26 (77%) hypotheses about correlations between the appearance scales were supported, two of three (67%) hypotheses about correlations between the health-related quality of life scales were supported, and 16 of 23 (70%) hypotheses about correlations between the appearance and health-related quality of life scales were supported. CONCLUSIONS: Cross-sectional construct validity of the CLEFT-Q scales adds further evidence of the psychometric properties of this instrument.

Factors Associated with Adolescent and Young Adult Males with Cancer Attending Fertility Consultation: A Population-Based Cohort Study in Ontario, Canada.

Purpose: Cancer and its treatment can impair fertility in men. It is recommended that they be referred for fertility consultation before the start of treatment. This study examined factors associated with men attending a fertility consultation within 30 days of diagnosis. Methods: Males 15 to 39 years of age, diagnosed with cancer in Ontario, Canada, between 2006 and 2019, were identified from the Ontario Cancer Registry. Linked administrative data were used to obtain other clinical and sociodemographic variables. The main outcome was a fertility consultation within 30 days of diagnosis, defined using Ontario Health Insurance Plan billing codes (606 or 628). A backward selection multivariate logistic regression was performed. Results: Of 13,720 cases identified, 8.5% attended a fertility consultation within 30 days of diagnosis. A more recent year of diagnosis (odds ratio [OR] = 5.5; 95% confidence interval [CI] 4.6-6.6), living in an urban area (OR = 1.3; 95% CI 1.0-1.8), receiving radiation therapy (OR = 1.4; 95% CI 1.2-1.6), chemotherapy (OR = 1.9; 95% CI 1.6-2.2), and reproductive organ-related cancer surgery (OR = 1.5; 95% CI 1.2-1.7) were associated with a greater likelihood of attending a consultation. Older age (OR = 0.2; 95% CI 0.1-0.2), living in a northern region (OR = 0.3; 95% CI 0.2-0.5), having a cancer with low (OR = 0.3; 95% CI 0.2-0.4) or moderate risk to fertility (OR = 0.6; 95% CI 0.5-0.7), and residing in a neighborhood with lower income (OR = 0.4; 95% CI 0.3-0.5) or residential instability quintile (OR = 0.8; 95% CI 0.6-1.0) were associated with being less likely to attend a consultation. Conclusion: Although rates of fertility consultation have increased over time, these remain low in various clinical and demographic groups. Funding for fertility preservation appears to have had an important impact on fertility consultation in young men with cancer.

Generic Health-Related Quality of Life Utility Measure for Preschool Children (Health Utilities Preschool): Design, Development, and Properties.

OBJECTIVES: Health Utilities Preschool (HuPS) was developed to fill the need for a generic preference-based measure (GPM) applicable in early childhood. A GPM has all the properties for higher-order summary measures, such as quality-adjusted life-years, required to inform important policy decisions regarding health and healthcare services. METHODS: Development was in accordance with published standards for a GPM, statistical procedures, and modeling. HuPS incorporates key components of 2 existing measurement systems: Health Status Classification System for Preschool Children and Health Utilities Index Mark 3 (HUI3). The study included a series of 4 measurement surveys: definitional, adaptational, quantificational, and evaluational health-related quality of life (HRQL). HuPS measurements were evaluated for reliability, validity, interpretability, and acceptability. RESULTS: Definitional measurements identified 8 Health Status Classification System for Preschool Children attributes in common with HUI3 (vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain and discomfort), making the HUI3 scoring equation commensurate with HuPS health states. Adaptational measurements informed the content of attribute-level descriptions (n = 35). Quantificational measurements determined level scoring coefficients. HRQL scoring inter-rater reliability (intraclass correlation coefficient = 0.79) was excellent. Continuity of HRQL scoring with HUI3 was reliable (intraclass correlation coefficient = 0.80, P < .001) and valid (mean absolute difference = 0.016, P = .396). CONCLUSIONS: HuPS is an acceptable, reliable, and valid GPM. HRQL scoring is continuous with HUI3. Continuity expands the applicability of GPM (HUI3) scoring to include subjects as young as 2 years of age. Widespread applications of HuPS would inform important health policy and management decisions as HUI3 does for older subjects.

Patient-reported outcomes in childhood head and neck rhabdomyosarcoma survivors and their relation to physician-graded adverse events-A multicenter study using the FACE-Q Craniofacial module.

INTRODUCTION: Adverse events (AE) of treatment are prevalent and diverse in head and neck rhabdomyosarcoma (HNRMS) survivors. These AEs are often reported by physicians; however, patients' perceptions of specific AE are not well known. In this study, we explored patient-reported outcomes measuring appearance, health-related quality of life (HRQOL), and facial function in HNRMS survivors. Second, we assess the relationship between physician grading of AE and patient reporting. MATERIALS AND METHODS: Survivors of pediatric HNRMS, diagnosed between 1993 and 2017, who were at least 2 years after completing treatment were invited to an outpatient clinic as part of a multicenter cross-sectional cohort study. At the outpatient clinics, survivors aged ≥8 years filled out the FACE-Q Craniofacial module; a patient-reported outcome instrument measuring issues specific to patients with facial differences. AE were systematically assessed by a multidisciplinary team based on the Common Terminology Criteria of Adverse Events system. RESULTS: Seventy-seven survivors with a median age of 16 years (range 8-43) and median follow-up of 10 years (range 2-42) completed the questionnaire and were screened for AEs. Patient-reported outcomes varied widely between survivors. Many survivors reported negative consequences: 82% on appearance items, 81% on HRQOL items, and 38% on facial function items. There was a weak correlation between physician-scored AEs and the majority of patient-reported outcomes specific for those AEs. CONCLUSIONS: Physician-graded AEs are not sufficient to provide tailored care for HNMRS survivors. Findings from this study highlight the importance of incorporating patient-reported outcome measures in survivorship follow-up.

Patient-reported outcome measures for patients with nail conditions: a systematic review of the psychometric evidence.

Nail conditions have an impact on appearance, function, and quality of life of patients. Patient reported outcome measures (PROMs) are important tools for evaluating treatment success from the patient perspective. It is important to understand the quality of PROMs to help guide selection of appropriate tools. The aim of this study was to critically appraise the psychometric properties of nail-specific PROMs using COSMIN guidelines. A systematic review was conducted in May 2019 to identify development and validation articles for nail-specific PROMs. Abstracts and subsequent full-texts were screened by two reviewers for eligibility. Data were extracted for study characteristics and psychometric properties. The risk of bias checklist was completed, and ratings applied to psychometric properties as per COSMIN guidelines. Modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria were applied based on the risk of bias checklist to assess methodological quality. The review identified 3289 articles of which 430 full-text articles were screened, nine of which met eligibility criteria. Included papers were for seven PROMs and in total reported on 31of 49 possible measurement properties. Of the 31 measurement properties reported, nine (29%) were rated as insufficient or indeterminate. The modified GRADE methodological quality rating was low or very low for 16 (32.7%) measurement properties, and 18 (36.7%) measurement properties were not described by any PROM. Currently there are no nail-specific PROMS available that demonstrate adequate validity, reliability, or responsiveness, according to COSMIN guidelines. Further research is required to assess missing or insufficiently tested measurement properties in all the PROMs identified.