The State of Surgical Research in Sub-Saharan Africa: An Urgent Call for Surgical Research Trainers.

Background: Surgery in low- and middle-income countries (LMICs) is poorly developed because of years of neglect. Sustained research on global surgery led to its recognition as an indivisible and indispensable part of primary healthcare in 2015. However, this has had little visible effect on surgical ecosystems within LMICs, especially in sub-Saharan Africa (SSA). SSA surgical research systems strengthening, which includes skills transfer, with local priority setting driving the research agenda, is needed to propel global surgery into the future. Methods: The authors performed a literature review of the state of surgical research within SSA and also report the initial efforts of two research training nonprofits to empower young African surgeons with research skills. Results: Surgical research in SSA is disadvantaged even before it is birthed, facing monumental challenges at every stage of development, from research agenda determination to funding, study execution, and publication. Compared with a global output of 17.49 publications per 100,000 population, SSA produces 0.9 (P < 0.0001). The Surgeons in Humanitarian Alliance for Reconstructive, Research, and Education and Enabling Africa Clinical Health Research programs are involved in the longitudinal research mentorship of surgical residents within SSA; the improved quality of research and successful publications by participants suggest nascent steps in growing young surgical scientists. Conclusions: In the absence of an existing surgical research infrastructure within LMICs, global surgery research trainers should link up and collaborate to help develop a surgical research community that will provide the local data required to help transform the SSA surgical ecosystem.

Adding Patient-Reported Outcomes to the American College of Surgeons National Surgical Quality Improvement Program: Results of the First 33,842 Patients from 65 Hospitals.

OBJECTIVES: To investigate the initial set of patient-reported outcomes (PROs) in the ACS NSQIP and their associations with 30-day surgical outcomes. BACKGROUND: PROs provide important information that can be used to improve routine care and facilitate quality improvement. The ACS conducted a demonstration project to capture PROs into the NSQIP to complement clinical data. METHODS: From 2/2020-3/2023, 65 hospitals collected PROMIS measures assessing global health, pain interference, fatigue, and physical function from patients accrued into the NSQIP. Using multivariable mixed regression, we compared the scores of patients with and without 30-day complications and further analyzed scores exceeding one standard deviation (1-SD) worse than national benchmarks. RESULTS: Overall, 33842 patients completed the PROMIS measures a median 58 days (IQR 47-72) postoperatively. Among patients without complications (n=31210), 33.9% had PRO scores 1-SD worse than national benchmarks. Patients with complications were 1.7-times more likely to report worse PROs (95% CI 1.6-1.8). Patients with complications had lower scores for global physical health (adjusted mean difference [AMD] 2.6, 95% CI 2.2-3.0), lower for global mental health (AMD 1.8, 95% CI 1.4-2.2), higher for pain interference (AMD 2.4, 95% CI 2.0-2.8), higher fatigue (AMD 2.7, 95% CI 2.3-3.1), and lower physical function (AMD 3.2, 95% CI 2.8-3.5). CONCLUSIONS: Postoperative complications negatively affect multiple key dimensions of patients' health-related quality of life. PROs were well below national benchmarks for many patients, even among those without complications. Identifying solutions to improve PROs after surgery thus remains a tremendous quality opportunity.

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.

Patient-Reported Outcome Measures Within a National Multispecialty Surgical Quality Improvement Program.

Importance: Patient-reported outcome measures (PROMs) are increasingly recognized for their ability to promote patient-centered care, but concerted health information technology (HIT)-enabled PROM implementations have yet to be achieved for national surgical quality improvement. Objective: To evaluate the feasibility of collecting PROMs within a national surgical quality improvement program. Design, Setting, and Participants: This was a pragmatic implementation cohort study conducted from February 2020 to March 2023. Hospitals in the US participating in the American College of Surgeons National Surgical Quality Improvement Program and their patients were included in this analysis. Exposures: Strategies to increase PROM collection rates were identified using the Institute for Healthcare Improvement (IHI) Framework for Spread and the Consolidated Framework for Implementation Research and operationalized with the IHI Model for Improvement's Plan-Do-Study-Act (PDSA) cycles. Main Outcomes and Measures: The primary goal was to accrue more than 30 hospitals and achieve collection rates of 30% or greater in the first 3 years. Logistic regression was used to identify hospital-level factors associated with achieving collection rates of 30% or greater and to identify patient-level factors associated with response to PROMs. Results: At project close, 65 hospitals administered PROMs to 130 365 patients (median [IQR] age, 60.1 [46.2-70.0] years; 77 369 female [59.4%]). Fifteen PDSA cycles were conducted to facilitate implementation, primarily targeting the Consolidated Framework for Implementation Research domains of Inner Setting (ie, HIT platform) and Individuals (ie, patients). The target collection rate was exceeded in quarter 3 (2022). Fifty-eight hospitals (89.2%) achieved collection rates of 30% or greater, and 9 (13.8%) achieved collection rates of 50% or greater. The median (IQR) maximum hospital-level collection rate was 40.7% (34.6%-46.7%). The greatest increases in collection rates occurred when both email and short-message service text messaging were used, communications to patients were personalized with their surgeon's and hospital's information, and the number of reminders increased from 2 to 5. No identifiable hospital characteristic was associated with achieving the target collection rate. Patient age and insurance status contributed to nonresponse. Conclusions and Relevance: Results of this cohort study suggest that the large-scale electronic collection of PROMs into a national multispecialty surgical registry was feasible. Findings suggest that HIT platform functionality and earning patient trust were the keys to success; although, iterative opportunities to increase collection rates and address nonresponse remain. Future work to drive continuous surgical quality improvement with PROMs are ongoing.

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.

A Content and Readability Analysis of Genitourinary and Sexual Health-Related Patient-Reported Outcome Measures in Gender-Affirming Care.

OBJECTIVES: To the evaluate the readability and comprehensiveness of genitourinary and sexual health-related patient-reported outcomes (PROMs) used in gender-affirming care. METHODS: Common PROMs that measure genitourinary and sexual health-related outcomes in gender-affirming care literature were identified from six recent systematic reviews. Readability analysis was completed at the level of individual items and full scale using established readability assessment tool, including Flesch Kincaid Grade Level (FKGL), Gunning Fog Score (GF), Coleman Liau Index (CLI), and Simple Measure of Gobbledygook (SMOG) Index. The concepts measured by the PROMs were evaluated for comprehensiveness. RESULTS: 25 PROMs were included, of which 12 assessed genitourinary outcomes and 13 assessed sexual health outcomes. A total of seven genitourinary domains and eight sexual health domains were identified during concept mapping. Readability analysis showed a median PROM grade level of 9.0 and 9.5 in genitourinary and sexual PROMs, respectively. The Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction v2.0 had the lowest median reading grade level of 5.7, and the Female Sexual Function Index has the highest median reading grade level of 13.9. No single PROM was found to be comprehensive. Multiple PROMs contained double-barreled items or used outdated terminology. CONCLUSIONS: Most PROMs used in the genital gender-affirming literature failed to meet the readability recommendations for patient-facing material and were culturally unfit for use in transgender and gender-diverse individuals. None of the PROMs were found to be comprehensive for evaluating outcomes of gender-affirming care. Validated gender-affirming care-specific PROMs that are comprehensible, comprehensive, and relevant are urgently needed.

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.

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.

Patterns of Social Needs Predict Quality-of-Life and Healthcare Utilization Outcomes in Patients from a Large Hospital System.

BACKGROUND: Unmet social needs (SNs) often coexist in distinct patterns within specific population subgroups, yet these patterns are understudied. OBJECTIVE: To identify patterns of social needs (PSNs) and characterize their associations with health-related quality-of-life (HRQoL) and healthcare utilization (HCU). DESIGN: Observational study using data on SNs screening, HRQoL (i.e., low mental and physical health), and 90-day HCU (i.e., emergency visits and hospital admission). Among patients with any SNs, latent class analysis was conducted to identify unique PSNs. For all patients and by race and age subgroups, compared with no SNs, we calculated the risks of poor HRQoL and time to first HCU following SNs screening for each PSN. PATIENTS: Adult patients undergoing SNs screening at the Mass General Brigham healthcare system in Massachusetts, United States, between March 2018 and January 2023. MAIN MEASURES: SNs included: education, employment, family care, food, housing, medication, transportation, and ability to pay for household utilities. HRQoL was assessed using the Patient-Reported Outcomes Measurement Information System Global-10. KEY RESULTS: Six unique PSNs were identified: "high number of social needs," "food and utility access," "employment needs," "interested in education," "housing instability," and "transportation barriers." In 14,230 patients with HRQoL data, PSNs increased the risks of poor mental health, with risk ratios ranging from 1.07(95%CI:1.01-1.13) to 1.80(95%CI:1.74-1.86). Analysis of poor physical health yielded similar findings, except that the "interested in education" showed a mild protective effect (0.97[95%CI:0.94-1.00]). In 105,110 patients, PSNs increased the risk of 90-day HCU, with hazard ratios ranging from 1.09(95%CI:0.99-1.21) to 1.70(95%CI:1.52-1.90). Findings were generally consistent in subgroup analyses by race and age. CONCLUSIONS: Certain SNs coexist in distinct patterns and result in poorer HRQoL and more HCU. Understanding PSNs allows policymakers, public health practitioners, and social workers to identify at-risk patients and implement integrated, system-wide, and community-based interventions.

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.

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.

FACE-Q for Measuring Patient-reported Outcomes after Facial Skin Cancer Surgery: Cross-cultural Validation.

Background: Facial skin cancer and its surgical treatment can affect health-related quality of life. The FACE-Q Skin Cancer Module is a patient-reported outcome measure that measures different aspects of health-related quality of life and has recently been translated into Dutch. This study aimed to evaluate the performance of the translated version in a Dutch cohort using modern psychometric measurement theory (Rasch). Methods: Dutch participants with facial skin cancer were prospectively recruited and asked to complete the translated FACE-Q Skin Cancer Module. The following assumptions of the Rasch model were tested: unidimensionality, local independence, and monotonicity. Response thresholds, fit statistics, internal consistency, floor and ceiling effects, and targeting were assessed for all scales and items within the scales. Responsiveness was tested for the "cancer worry" scale. Results: In total, 259 patients completed the preoperative questionnaire and were included in the analysis. All five scales assessed showed a good or sufficient fit to the Rasch model. Unidimensionality and monotonicity were present for all scales. Some items showed a local dependency. Most of the scales demonstrate ordered item thresholds and appropriate fit statistics. Conclusions: The FACE-Q Skin Cancer Module is a well-designed patient-reported outcome measure that shows psychometric validity for the translated version in a Dutch cohort, using classical and modern test theory.

Patient-reported outcome measures for primary hyperparathyroidism: a systematic review of measurement properties.

BACKGROUND: The quality of patient-reported outcome measures (PROMs) used to assess the outcomes of primary hyperparathyroidism (PHPT), a common endocrine disorder that can negatively affect patients' health-related quality of life due to chronic symptoms, has not been rigorously examined. This systematic review aimed to summarize and evaluate evidence on the measurement properties of PROMs used in adult patients with PHPT, and to provide recommendations for appropriate measure selection. METHODS: After PROSPERO registration (CRD42023438287), Medline, EMBASE, CINAHL Complete, Web of Science, PsycINFO, and Cochrane Trials were searched for full-text articles in English investigating PROM development, pilot studies, or evaluation of at least one PROM measurement property in adult patients with any clinical form of PHPT. Two reviewers independently identified studies for inclusion and conducted the review following the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) Methodology to assess risk of bias, evaluate the quality of measurement properties, and grade the certainty of evidence. RESULTS: From 4989 records, nine PROM development or validation studies were identified for three PROMs: the SF-36, PAS, and PHPQoL. Though the PAS demonstrated sufficient test-retest reliability and convergent validity, and the PHPQoL sufficient test-retest reliability, convergent validity, and responsiveness, the certainty of evidence was low-to-very low due to risk of bias. All three PROMs lacked sufficient evidence for content validity in patients with PHPT. CONCLUSIONS: Based upon the available evidence, the SF-36, PAS, and PHPQoL cannot currently be recommended for use in research or clinical care, raising important questions about the conclusions of studies using these PROMs. Further validation studies or the development of more relevant PROMs with strong measurement properties for this patient population are needed.

BREAST-Q REACT: Qualitative Assessment of the Design, Functionality, and Clinical Utility of a New Score Interpretation Tool.

BACKGROUND: The BREAST-Q real-time engagement and communication tool (REACT) was developed to aid with BREAST-Q score interpretation and guide patient-centered care. OBJECTIVE: The purpose of this qualitative study was to examine the perspectives of patients and providers on the design, functionality, and clinical utility of REACT and refine the REACT based on their recommendations. METHODS: We conducted three patient focus groups with women who were at least 6 postoperative months from their postmastectomy breast reconstruction, and two provider focus groups with plastic surgeons, breast surgeons, and advanced practice providers. Focus groups were audio-taped, transcribed verbatim, and analyzed thematically. RESULTS: A total of 18 breast reconstruction patients and 14 providers participated in the focus groups. Themes identified by thematic analysis were organized into two categories: (1) design and functionality, and (2) clinical utility. On the design and functionality of REACT, four major themes were identified: visual appeal and usefulness; contextualizing results; ability to normalize patients' experiences, noting participants' concerns; and suggested modifications. On the clinical utility of REACT, three major themes were identified: potential to empower patients to communicate with their providers; increase patient and provider motivation to engage with the BREAST-Q; and effective integration into clinical workflow. CONCLUSION: Patients and providers in this qualitative study indicated that with some modifications, REACT has a great potential to elevate the clinical utility of the BREAST-Q by enhancing patient-provider communication that can lead to patient-centered, clinically relevant action recommendations based on longitudinal BREAST-Q scores.

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.

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.

Readability analysis and concept mapping of PROMs used for headache disorders.

OBJECTIVE: To assess the readability and the comprehensiveness of patient-reported outcome measures (PROMs) utilized in primary headache disorders literature. BACKGROUND: As the health-care landscape has evolved toward a patient-centric model, numerous PROMs have been developed to capture treatment outcomes in patients with headache disorders. For these PROMs to advance our understanding of headache disorders and their treatment impact, they must be easy to understand (i.e., reading grade level 6 or less) and comprehensively capture what matters to patients with headache. The aim of this study was to (a) assess the readability of PROMs utilized in headache disorders literature, and (b) assess the comprehensiveness of PROMs by mapping their content to a health-related quality of life framework. METHODS: In this scoping review, recently published systematic reviews were used to identify PROMs used in primary headache disorders literature. Readability analysis was performed at the level of individual items and full PROM using established readability metrics. The content of the PROMs was mapped against a health-related quality-of-life framework by two independent reviewers. RESULTS: In total, 22 PROMs (15 headache disorders related, 7 generic) were included. The median reading grade level varied between 7.1 (interquartile range [IQR] 6.3-7.8) and 12.7 (IQR 11.8-13.2). None of the PROMs were below the recommended reading grade level for patient-facing material (grade 6). Three PROMs, the Migraine-Treatment Assessment Questionnaire, the Eurolight, and the European Quality of Life 5 Dimensions 3 Level Version, were between reading grade levels 7 and 8; the remaining 19 PROMs were above reading grade level 8. In total, the PROMs included 425 items. Most items (n = 134, 32%) assessed physical function (e.g., work, activities of daily living). The remaining items assessed physical symptoms (n = 127, 30%; e.g., pain, nausea), treatment effects on symptoms (n = 65, 15%; e.g., accompanying symptoms relief, headache relief), treatment impact (n = 56, 13%; e.g., function, side effects), psychological well-being (n = 41, 10%; e.g., anger, frustration), social well-being (n = 29, 7%; e.g., missing out on social activities, relationships), psychological impact (n = 14, 3%; e.g., feeling [not] in control, feeling like a burden), and sexual well-being (n = 3, 1%; e.g., sexual activity, sexual interest). Some of the items pertained to treatment (n = 27, 6%), of which most were about treatment type and use (n = 12, 3%; e.g., medication, botulinum toxin), treatment access (n = 10, 2%; e.g., health-care utilization, cost of medication), and treatment experience (n = 9, 2%; e.g., treatment satisfaction, confidence in treatment). CONCLUSION: The PROMs used in studies of headache disorders may be challenging for some patients to understand, leading to inaccurate or missing data. Furthermore, no available PROM comprehensively measures the health-related quality-of-life impact of headache disorders or their treatment, resulting in a limited understanding of patient-reported outcomes. The development of an easy-to-understand, comprehensive, and validated headache disorders-specific PROM is warranted.