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.

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.

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

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

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

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

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.

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.

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.

The Use of Unlisted Billing Codes for Microsurgical Breast Reconstruction and Implications for Code Consolidation.

BACKGROUND: Private insurers have considered consolidating the billing codes presently available for microvascular breast reconstruction. There is a need to understand how these different codes are currently distributed and used to help inform how coding consolidation may impact patients and providers. METHODS: Using the Massachusetts All-Payer Claims Database between 2016 and 2020, patients who underwent microsurgical breast reconstruction following mastectomy for cancer-related indications were identified. Multivariable logistic regression was used to test whether an S2068 claim was associated with insurance type and median household income by patient ZIP code. The ratio of S2068 to CPT19364 claims for privately insured patients was calculated for providers practicing in each county. Total payments for professional fees were compared between billing codes. RESULTS: There were 272 claims for S2068 and 209 claims for CPT19364. An S2068 claim was associated with age < 45 years (OR: 1.89, 95% CI: 1.11-3.20, p = 0.019), more affluent ZIP codes (OR: 1.11, 95% CI: 1.03-1.19, p = 0.004), and private insurance (OR: 16.13, 95% CI: 7.81-33.33, p < 0.001). Median total payments from private insurers were 101% higher for S2068 than for CPT19364. In all but two counties (Worcester and Hampshire), the S-code was used more frequently than CPT19364 for their privately insured patients. CONCLUSION: Coding practices for microsurgical breast reconstruction lacked uniformity in Massachusetts, and payments differed greatly between S2068 and CPT19364. Patients from more affluent towns were more likely to have S-code claims. Coding consolidation could impact access, as the majority of providers in Massachusetts might need to adapt their practices if the S-code were discontinued.

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.

Use of patient-reported outcome measures after breast reconstruction in low- and middle-income countries: a scoping review.

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly administered in high-income countries to monitor health-related quality of life of breast cancer patients undergoing breast reconstruction. Although low- and middle-income countries (LMICs) face a disproportionate burden of breast cancer, little is known about the use of PROMs in LMICs. This scoping review aims to examine the use of PROMs after post-mastectomy breast reconstruction among patients with breast cancer in LMICs. METHODS: MEDLINE, Embase, Web of Science, CINAHL, and PsycINFO were searched in August 2022 for English-language studies using PROMs after breast reconstruction among patients with breast cancer in LMICs. Study screening and data extraction were completed. Data were analyzed descriptively. RESULTS: The search produced 1024 unique studies, 33 of which met inclusion criteria. Most were observational (48.5%) or retrospective (33.3%) studies. Studies were conducted in only 10 LMICs, with 60.5% in China and Brazil and none in low-income countries. Most were conducted in urban settings (84.8%) and outpatient clinics (57.6%), with 63.6% incorporating breast-specific PROMs and 33.3% including breast reconstruction-specific PROMs. Less than half (45.5%) used PROMs explicitly validated for their populations of interest. Only 21.2% reported PROM response rates, ranging from 43.1 to 96.9%. Barriers and facilitators of PROM use were infrequently noted. CONCLUSIONS: Despite the importance of PROM collection and use in providing patient-centered care, it continues to be limited in middle-income countries and is not evident in low-income countries after breast reconstruction. Further research is necessary to determine effective methods to address the challenges of PROM use in LMICs.

Results of a Pilot Virtual Microsurgery Course for Plastic Surgeons in LMICs.

Background: The Plastic Surgery Foundation's Surgeons in Humanitarian Alliance for Reconstruction, Research and Education (SHARE) program seeks to expand surgical capacity worldwide through mentorship and training for local plastic surgeons. This study aims to define the need for microsurgery training among SHARE global fellows and describe results of a pilot course. Methods: Ten participants of the SHARE Virtual Microsurgical Skills Course were asked to complete an anonymous survey. Pre- and post-course response rates were 100% and 50.0%, respectively. Results: There was a high incidence of microsurgical problems encountered in the clinical setting. Resource availability was varied, with high access to loupes (100%), yet limited access to microsurgery instruments (50%), medications (40%), operating microscope (20%), skilled nursing (0%) and appropriate peri-operative care settings (0%). Participants identified vessel preparation, instrument selection, and suture handling as priority learning objectives for a microsurgery skills course. Post-course satisfaction with learning objectives was high (60% "very good," 40% "excellent"). Participants reported high levels of improvement in suture handling (Likert 4.60±0.55), end-to-end anastomosis (4.40±0.55), instrument selection (4.20±0.45), vessel preparation (4.20±0.45), and economy of motion (4.20±0.45). Conclusions: This study demonstrates a high frequency of reconstructive problems encountered by global fellows yet low access to appropriate resources to perform microsurgical procedures. Initial results from a pilot virtual microsurgery course demonstrate very high satisfaction and high self-rated improvement in key microsurgical skills. The virtual course is an effective and accessible format for training surgeons in basic microsurgery skills and can be augmented by providing longitudinal opportunities for remote feedback.

Identifying Core Outcome Domains in Chronic Skin Disease Using the Best-Worst Scaling Method.

Importance: The use of patient-reported outcome measures (PROMs) potentially holds promise as an opportunity to improve outcomes and quality of care for patients with skin disease, but the routine use of PROMs remains limited. While the Patient-Reported Outcomes Measurement Information System (PROMIS) has several strengths and domains relevant to those with chronic skin disease, it is not clear which are most useful. Objective: To determine which PROMIS domains are most meaningful to those with chronic skin disease to develop a PROMIS profile that effectively captures the experience of living with these skin diseases. Design, Setting, and Participants: This cross-sectional study was based on data gathered from an internet survey that was administered to a sample of adult respondents in the US on the Prolific Platform and ResearchMatch and through the National Psoriasis Foundation. A list of PROMIS domains relevant to chronic skin disease was developed through literature review. These domains were included in a best-worst scaling exercise, in which participants were shown 12 sets of 4 domains and asked to choose which domain in each set was the most important and least important to their experience. Participants completed the survey between December 2022 and June 2023. Data were analyzed in June 2023. Main Outcomes and Measures: Ratio-scaled preference score for each of the domains. Results: Of 939 total participants, 559 (59.5%) were female, 20 (2.1%) gender nonconforming, 7 (0.7%) transgender men, and 1 (0.1%) transgender women; there were 4 American Indian/Alaska Native (0.4%), 50 Asian (5.3%), 63 Black (6.7%), 66 Hispanic or Latino/a/x (7.0%), 2 Native Hawaiian/Pacific Islander (0.2%), 749 White (79.8%), and 42 multiracial individuals (4.5%). The survey was completed by 200 participants with acne, 316 with psoriasis, 199 with atopic dermatitis, and 224 with various chronic skin diseases. For those with acne, the highest-scored domains were body image (15.66), appearance (14.96), life satisfaction (11.29), depression (9.25), and anxiety (9.18). For those with psoriasis, the highest-scored domains were life satisfaction (11.31), appearance (11.05), itch (10.98), pain (9.97), and body image (8.75). For those with atopic dermatitis, the highest-scored domains were itch (12.60), life satisfaction (11.65), appearance (11.40), body image (11.25), and pain (10.03). Conclusion and Relevance: The results of this study suggest that body image, appearance, life satisfaction, itch, pain, anxiety, and depression were highly rated across the surveys. By identifying the PROMIS domains most important to individuals with chronic skin disease, clinicians can choose the domains that are most relevant to patients. In addition, this may guide the construction of a PROMIS profile that effectively captures the experience of living with these skin diseases and can serve as a patient-reported measure of disease severity and treatment effectiveness.

Translation and psychometric assessment of the mastectomy module of the BREAST-Q questionnaire for use in Nigeria.

BACKGROUND: The majority of non-metastatic breast cancer patients in sub-Saharan Africa are recommended to have mastectomy. The impact of mastectomy on a predominantly young African patient population requires evaluation. The BREAST-Q is a validated patient-reported outcome measure of quality-of-life following breast surgery that has been translated into 30 languages-none in Africa. This study aimed to translate and assess the psychometric properties of the mastectomy module of the BREAST-Q for use in Nigeria. METHODS: The BREAST-Q mastectomy module was translated from English to Yoruba and its psychometric properties assessed using best practice guidelines. Translation was performed in 4 steps: forward translation (x2), back translation, back translation review, and cognitive interviews with post-mastectomy patients. The translated BREAST-Q instrument was administered to post-mastectomy patients (n = 21) alongside the EORTC-QLQ BR23 to evaluate construct validity. Test-retest reliability was evaluated using intraclass correlation coefficients (ICC); surveys were re-administered 4 weeks apart. RESULTS: The translation process identified English phrases not amenable to direct translation, including "emotionally healthy" and descriptions of pain ("nagging," "throbbing," "sharp"). Translations were amended to reflect local context and question intent. During cognitive interviews, patients provided suggestions to simplify complex phrases, e.g. "discomfort in your breast area.". Internal consistency within scales was over 0.70 for psychosocial wellbeing (α = 0.84-0.87), sexual wellbeing (α = 0.98-0.99), physical wellbeing in chest (α = 0.84-0.86), and satisfaction with care (α = 0.89-0.93). ICC for test-retest reliability was moderate (0.46-0.63). CONCLUSIONS: The Yoruba version of the BREAST-Q mastectomy module presents a unique opportunity to adequately capture the experiences of Nigerian women post mastectomy. This instrument is being used in a pilot study of Nigerian patients to identify targets for intervention to improve the patient experience and compliance with breast cancer surgery.

Remote Symptom Monitoring with Clinical Alerts Following Mastectomy: Do Early Symptoms Predict 30-Day Surgical Complications.

BACKGROUND: Electronic patient-reported outcome measures (ePROMs) for real-time remote symptom monitoring facilitate early recognition of postoperative complications. We sought to determine whether remote, electronic, patient-reported symptom-monitoring with Recovery Tracker predicts 30-day readmission or reoperation in outpatient mastectomy patients. METHODS: We conducted a retrospective review of breast cancer patients who underwent outpatient (< 24-h stay) mastectomy with or without reconstruction from April 2017 to January 2022 and who received the Recovery Tracker on Days 1-10 postoperatively. Of 5,130 patients, 3,888 met the inclusion criteria (2,880 mastectomy with immediate reconstruction and 1,008 mastectomy only). We focused on symptoms concerning for surgical complications and assessed if symptoms reaching prespecified alert levels-prompting a nursing call-predicted risk of 30-day readmission or reoperation. RESULTS: Daily Recovery Tracker response rates ranged from 45% to 70%. Overall, 1,461 of 3,888 patients (38%) triggered at least one alert. Most red (urgent) alerts were triggered by pain and fever; most yellow (less urgent) alerts were triggered by wound redness and pain severity. The 30-day readmission and reoperation rates were low at 3.8% and 2.4%, respectively. There was no statistically significant association between symptom alerts and 30-day reoperation or readmission, and a clinically relevant increase in risk can be excluded (odds ratio 1.08; 95% confidence interval 0.8-1.46; p = 0.6). CONCLUSIONS: Breast cancer patients undergoing mastectomy with or without reconstruction in the ambulatory setting have a low burden of concerning symptoms, even in the first few days after surgery. Patients can be reassured that symptoms that do present resolve quickly thereafter.

Body Contouring Surgery After Bariatric Surgery Improves Long-Term Health-Related Quality of Life and Satisfaction With Appearance: An International Longitudinal Cohort Study Using the BODY-Q.

OBJECTIVE: To examine health-related quality of life (HRQL) and satisfaction with appearance in patients who have undergone bariatric surgery (BS) with or without subsequent body contouring surgery (BCS) in relation to the general population normative for the BODY-Q. BACKGROUND: The long-term impact of BS with or without BCS has not been established using rigorously developed and validated patient-reported outcome measures. The BODY-Q is a patient-reported outcome measure developed to measure changes in HRQL and satisfaction with appearance in patients with BS and BCS. METHODS: Prospective BODY-Q data were collected from 6 European countries (Denmark, the Netherlands, Finland, Germany, Italy, and Poland) from June 2015 to February 2022 in a cohort of patients who underwent BS. Mixed-effects regression models were used to analyze changes in HRQL and appearance over time between patients who did and did not receive BCS and to examine the impact of patient-level covariates on outcomes. RESULTS: This study included 24,604 assessments from 5620 patients. BS initially led to improved HRQL and appearance scores throughout the first postbariatric year, followed by a gradual decrease. Patients who underwent subsequent BCS after BS experienced a sustained improvement in HRQL and appearance or remained relatively stable for up to 10 years postoperatively. CONCLUSIONS: Patients who underwent BCS maintained an improvement in HRQL and satisfaction with appearance in contrast to patients who only underwent BS, who reported a decline in scores 1 to 2 years postoperatively. Our results emphasize the pivotal role that BCS plays in the completion of the weight loss trajectory.