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

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

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

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

"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.

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

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

Feasibility of implementing patient-reported outcome measures into routine breast cancer care delivery using a novel collection and reporting platform.

Objectives: imPROVE is a new Health Information Technology platform that enables systematic patient-reported outcome measure (PROM) collection through a mobile phone application. The purpose of this study is to describe our initial experience and approach to implementing imPROVE among breast cancer patients treated in breast and plastic surgery clinics. Materials and Methods: We describe our initial implementation in 4 phases between June 2021 and February 2022: preimplementation, followed by 3 consecutive implementation periods (P1, P2, P3). The Standards for Reporting Implementation Studies statement guided this study. Iterative Plan-Do-Study-Act (PDSA) cycles supported implementation, and success was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Results: Qualitative interviews conducted during the preimplementation phase elicited 4 perceived implementation barriers. Further feedback collected during each phase of implementation resulted in the development of brochures, posters in clinic spaces, and scripts for clinic staff to streamline discussions with patients, and the resolution of technical issues concerning patient login capabilities, such as compatibility with cell phone software and barriers to downloading imPROVE. Feedback also generated ideas for facilitating provider interpretation of PROM results. By the end of P3, 2961 patients were eligible, 1375 (46.4%) downloaded imPROVE, and 1070 (36.1% of those eligible, 78% of those who downloaded) completed at least 1 PROM. Discussion and Conclusion: Implementation efforts across 2 surgical departments at 2 academic teaching hospitals enabled collaboration across clinical specialties and longitudinal PROM reporting for patients receiving breast cancer care; the implementation effort also highlighted patient difficulties with mobile app-based PROM collection, particularly around initial engagement.

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.

Re-examining content validity of the BREAST-Q more than a decade later to determine relevance and comprehensiveness.

PURPOSE: The BREAST-Q is the most used patient-reported outcome measure (PROM) in breast cancer surgery. The purposes of this study were to re-examine the content validity of BREAST-Q cancer modules (mastectomy, lumpectomy and reconstruction) and to determine the need for new scales. METHODS: Interviews were conducted with women with breast cancer (Stage 0-4, any treatment), and were audio-recorded and transcribed verbatim. Deductive (based on original BREAST-Q conceptual framework) and inductive (new codes from the data) content analysis approaches were used to analyze the data. The number of codes that mapped to BREAST-Q were recorded. RESULTS: Dataset included 3948 codes from 58 participants. Most of the breast (n = 659, 96%) and all psychosocial (n = 127, 100%), sexual (n = 179, 100%) and radiation-related (n = 79, 100%) codes mapped to BREAST-Q Satisfaction with Breast, Psychosocial Wellbeing, Sexual Wellbeing and Adverse Effects of Radiation scales, respectively. For the physical wellbeing codes (n = 939) for breast/chest and arm, 34% (n = 321) mapped to the Physical Wellbeing-Chest scale. Most of the abdomen codes (n = 311) mapped to Satisfaction with Abdomen (n = 90, 76%) and Physical Wellbeing-Abdomen (n = 171, 89%) scales. Codes that did not map (n = 697, 30%) covered breast sensation and lymphedema. Concerns related to fatigue, cancer worry, and work impact were most reported and did not map to BREAST-Q. CONCLUSION: The BREAST-Q, which was developed using extensive patient input more than a decade ago, is still relevant. To ensure the BREAST-Q remains comprehensive, new scales for upper extremity lymphedema, breast sensation, fatigue, cancer worry, and work impact were developed.

Validation of the Dutch Version of the BODY-Q Measuring Appearance, Health-Related Quality of Life, and Experience of Healthcare in Patients Undergoing Bariatric and Body Contouring Surgery.

BACKGROUND: The BODY-Q is a patient-reported outcome measure developed for use in bariatric and body contouring surgery. OBJECTIVES: The objective of this study was to examine the validity and reliability of the Dutch version of the BODY-Q. METHODS: The BODY-Q consists of 163 items in 21 independently functioning scales that measure appearance, health-related quality of life, and experience of care. The data used to validate the Dutch BODY-Q were provided by 2 prospective multicenter cohort studies across 3 hospitals in the Netherlands. The BODY-Q was administered before and after surgery at 3 or 4 months and 12 months. Rasch measurement theory (RMT) analysis was used to evaluate the BODY-Q for targeting, category threshold order, Rasch model fit, Person Separation Index, and differential item functioning by language (original English data vs Dutch data). RESULTS: Data were collected between January 2016 and May 2019. The study included 876 participants, who provided 1614 assessments. Validity was supported by 3 RMT findings: most scales showed good targeting, 160 out of 163 items (98.2%) evidenced ordered thresholds, and 142 out of 163 items (87.1%) fitted the RMT model. Reliability was high with Person Separation Index values >0.70 for 19 out of 21 scales. There was negligible influence of differential item functioning by language on person item locations and the scale scoring. CONCLUSIONS: This study provides evidence for the reliability and validity of the Dutch BODY-Q for use in bariatric and body contouring patients in the Netherlands. The Dutch BODY-Q can be used in (inter)national research and clinical practice.

Using patient-reported outcome measures to assess psychological well-being in a non-representative US general population during the COVID-19 pandemic.

PURPOSE: The impact of the COVID-19 pandemic on psychological well-being will likely be long-lasting. Efforts directed towards monitoring the onset and progression of distress and mental health disorders are needed to identify and prioritize at-risk populations. This study assesses the psychological well-being of the United States (US) general population during the early phase of the COVID-19 COVID-19 pandemic using validated patient-reported outcome measures (PROMs). METHODS: A cross-sectional study design was used. Adults (18 years or older) who could read and write in English were recruited through Prolific in May 2020. Participants completed a REDCap survey including demographic and health-related questions and three PROMs measuring global health (PROMIS-10 Global Health), anxiety [Generalized Anxiety Disorder Scale-7 (GAD-7)], and depression [Patient Health Questionnaire-9 (PHQ-9)]. A multivariable linear regression was used to identify key factors associated with worse psychological well-being. RESULTS: Mean age of the 2023 participants was 31.92 ± 11.57 years (range, 18-82). Participants were mainly White (64.7%, n = 1309), female (52.2%, n = 1057), working full-time before the pandemic (43.5%, n = 879), and completed a college, trade, or university degree (40.7%, n = 823). Most participants reported mild to severe anxiety (57.3%, n = 1158) and depression (60%, n = 1276) on the GAD-7 and PHQ-9, respectively. Patient characteristics associated with worse psychological well-being included: age ≤ 39 years, non-White, female or gender diverse, BMI ≥ 30, uninsured, annual income ≤ $49,999 (USD), lower educational attainment, and belief that COVID-19 is deadlier than flu. CONCLUSION: PROMs can be used to assess and monitor psychological well-being during the COVID-19 pandemic and to inform the planning and delivery of targeted public health interventions to support at-risk populations.

Comparing Breast Sensation between Alloplastic and Autologous Breast Reconstruction Patients Using the BREAST-Q Sensation Module.

BACKGROUND: Sensory recovery of the breast is a compelling frontier in comprehensive postmastectomy breast reconstruction. This study uses the BREAST-Q Sensation Module to evaluate the differences in women who underwent an alloplastic versus autologous breast reconstruction. METHODS: Women with a history of breast cancer and postmastectomy breast reconstruction were recruited through the Love Research Army, United States. Participants completed the BREAST-Q Sensation Module, which consists of three scales: Breast Symptoms, Breast Sensation, and Quality of Life Impact. Descriptive statistics and multiple linear regression analyses were used to compare outcomes between women undergoing alloplastic or autologous breast reconstruction. RESULTS: Of 1204 respondents, 933 were included for analysis: 620 (66.5 percent) underwent alloplastic reconstruction and 313 (33.5 percent) underwent autologous reconstruction. The average age and body mass index were 59.2 ± 10.1 years and 26 ± 5 kg/m 2 , respectively. Autologous reconstruction patients scored an average of 6.1 points (95 percent CI, 3.9 to 8.4; p < 0.001) and 5.3 points (95 percent CI, 2.5 to 8.1; p = 0.001) higher on the Breast Symptoms and Quality of Life Impact scales, respectively. No difference (0.0 points, 95 percent CI, -2.9 to 3.0; p = 0.75) was observed for the Breast Sensation scale. Increased time since reconstruction had a positive impact on Breast Symptoms scale scores. Radiotherapy negatively affected scores on both Breast Symptoms and Quality of Life Impact scales. CONCLUSIONS: Autologous breast reconstruction may be associated with fewer abnormal breast sensations and better sensation-related quality of life in comparison to alloplastic reconstruction. This information can be incorporated during preoperative patient counseling when discussing reconstructive options.

User-centered design and agile development of a novel mobile health application and clinician dashboard to support the collection and reporting of patient-reported outcomes for breast cancer care.

Objectives: There is a need for advancements in health information technology that will transform how patient-reported outcomes (PRO) data are collected, reported, and used in breast cancer care. The objective of this study was to develop an innovative and customizable platform, called imPROVE to support PRO uptake in breast cancer care. Design: User-centered design and agile development were employed. Recurrent stakeholder meetings with experts in the field of breast cancer care, in-depth one-on-one qualitative interviews with a clinical sample of patients with breast cancer, and focus groups with Dana-Farber/Harvard Cancer Center (DF/HCC) Breast Cancer Advisory Group members, were used to elicit feedback for the design features and functions of a patient mobile application and clinician dashboard. Setting: This study was conducted at two academic hospitals in the USA. Participants: Participants included experts in the field of breast cancer care, value-based healthcare, and health information technology, a clinical sample of patients with breast cancer, and members of the DF/HCC Breast Cancer Advisory Group. Main outcome measures: imPROVE incorporates the International Consortium for Health Outcomes Measurement (ICHOM) breast cancer standard outcome set as well as the complete BREAST-Q Breast Cancer Module. Results: Feedback was elicited from eight stakeholder meetings (n=28 members), interviews with a clinical sample of patients (n=28), and two focus groups with members of the DF/HCC Breast Cancer Advisory Group (n=17 members in each focus group). Participant feedback led to the development of a patient mobile application consisting of five components (myCare, myStory, myResources, myCommunity, and myNotes) and a clinician dashboard that includes an overview table and individual patient profiles with data displays. Conclusions: imPROVE has the potential to transform the way we deliver care to patients. Developed from best practices in user-centered design, agile development, and qualitative methods; imPROVE addresses the needs of multiple stakeholders, including patients, clinicians, healthcare administrators, and researchers.

Danish translation and linguistic validation of new body-Q scales measuring expectations, eating behavior, distress, symptoms and work life.

The aim of this study was to translate and achieve a linguistical and cultural adaption of the newly developed BODY-Q Obesity Module for use in Danish patients. The BODY-Q Eating Module consists of five new modules aiming to measure expectations of weight-loss, eating behavior, eating-related distress, eating-related symptoms and work life. Translation and linguistic validation were performed using a combination of the recommendations developed by the World Health Organization and the International Society for Pharmacoeconomics and Outcomes Research. The translation was performed in five steps consisting of a forward translation, backward translation, expert panel meeting, cognitive debriefing and final proofreading. Each step aimed for a conceptual and cultural equal translation that was easily understood by patients. The discrepancies encountered in the forward translation included the use of layperson versus medical terminology, different tense and sentence structure. The harmonized version was then backwards translated which led to no conceptual differences. The expert panel reviewed the instrument in full and found two items needing correction in the instrument. Cognitive debriefing did not lead to any revisions and the instrument was well received by the participant group. Proofreading of the instrument led to few corrections in grammar and punctuation but no conceptual corrections. The translation of the BODY-Q Eating Module led to a conceptual and cultural equal version of the instrument for use in Danish patients. The instrument can be used in clinical care and research to inform advancements in the field of bariatric and body contouring surgery.

Enhancing Patient-Centered Surgical Care With Mobile Health Technology.

From smartphones or wearables to portable physiologic sensors and apps, healthcare is witnessing an exponential growth in mHealth-digital health tools used to support medical and surgical care, as well as public health. In surgery, there is interest in harnessing the capabilities of mHealth to improve the quality of patient-centered care delivery. Digitally delivered surveys have enhanced patient-reported outcome measurement and patient engagement throughout care. Wearable devices and sensors have allowed for the assessment of physical fitness before surgery and during recovery. Smartphone-based digital phenotyping has introduced novel methods of integrating multiple data streams (accelerometer, global positioning system, call and text logs) to create multidimensional digital health footprints for patients following surgery. Yet, with all the technological sophistication and 'big data' mHealth provides, widespread implementation has been elusive. Do clinicians and patients find these data valuable or clinically actionable? How can mHealth become integrated into the day-to-day workflows of surgical systems? Do these data represent opportunities to address disparities of care or worsen them? In this review, we discuss experiences and future opportunities to use mHealth to enhance patient-centered surgical care.

Patient-reported outcomes measures used in facial vascularized composite allotransplantation: A systematic literature review.

BACKGROUND: Facial vascularized composite allotransplantation (fVCA) is a life-enhancing procedure performed to improve quality of life (QOL). Patient-reported outcome measures (PROMs) are tools used to assess QOL from the patients' perspective, and are increasingly recognized as an important clinical metric to assess outcomes of treatment. A systematic literature review was performed to identify and appraise the content of PROMs used in fVCA. METHODS: We searched PUBMED/Medline, CINAHL, Embase, PsychInfo, and Web of Science from their inception through to June 2020. Included studies used a PROM in candidates and recipients of fVCA of any gender or age. We excluded abstracts, reviews, editorials, and dissertations. Items from each PROM were extracted and coded, using top-level codes and subcodes, to develop a preliminary conceptual framework of QOL concerns in fVCA, and to guide future PROM selection. RESULTS: Title and abstract screening of 6089 publications resulted in 16 studies that met inclusion criteria. Review of the 16 studies identified 38 PROMs, none of which were developed for fVCA. Review of the coded content for each PROM identified six top-level codes (appearance, facial function, physical, psychological and social health, and experience of care) and 16 subcodes, making up the preliminary conceptual framework. CONCLUSION: There are currently no PROMs designed to measure QOL concerns of fVCA candidates and recipients. Findings from this systematic review will be used to inform an interview guide for use in qualitative interviews to elicit and refine important concepts related to QOL in fVCA.

Time-Driven Activity-Based Costing in Breast Cancer Care Delivery.

BACKGROUND: Accurate measurement of healthcare costs is required to assess and improve the value of oncology care. OBJECTIVES: We aimed to determine the cost of breast cancer care provision across collaborating health care organizations. METHODS: We used time-driven activity-based costing (TDABC) to calculate the complete cost of breast cancer care-initial treatment planning, chemotherapy, radiation therapy, surgical resection and reconstruction, and ancillary services (e.g., psychosocial oncology, physical therapy)-across multiple hospital sites. Data were collected between December 2019 and February 2020. TDABC steps involved (1) developing process maps for care delivery pathways; (2) determine capacity cost rates for staff, medical equipment, and hospital space; (3) measure the time required for each process step, both manually through clinic observation and using data from the Real-Time Location System (RTLS); and (4) calculate the total cost of care delivery. RESULTS: Surgical care costs ranged from $1431 for a lumpectomy to $12,129 for a mastectomy with prepectoral implant reconstruction. Radiation therapy was costed at $1224 for initial simulation and patient education, and $200 for each additional treatment. Base costs for chemotherapy delivery were $382 per visit, with additional costs driven by chemotherapy agent(s) administered. Personnel expenses were the greatest contributor to the cost of surgical care, except in mastectomy with implant reconstruction, where device costs equated to up to 60% of the cost of surgery. CONCLUSION: The cost of complete breast cancer care depended on (1) treatment protocols; (2) patient choice of reconstruction; and (3) the need for ancillary services (e.g., physical therapy). Understanding the actual costs and cost drivers of breast cancer care delivery may better inform resource utilization to lower the cost and improve the quality of care.

Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice.

BACKGROUND: Patient-reported outcomes measures (PROMs) assess a patient's subjective appraisal of health outcomes from their own perspective. Despite hypothesised benefits that feedback  on PROMs can support decision-making in clinical practice and improve outcomes, there is uncertainty surrounding the effectiveness of PROMs feedback. OBJECTIVES: To assess the effects of PROMs feedback to patients, or healthcare workers, or both on patient-reported health outcomes and processes of care. SEARCH METHODS: We searched MEDLINE, Embase, CENTRAL, two other databases and two clinical trial registries on 5 October 2020. We searched grey literature and consulted experts in the field. SELECTION CRITERIA: Two review authors independently screened and selected studies for inclusion. We included randomised trials directly comparing the effects on outcomes and processes of care of PROMs feedback to healthcare professionals and patients, or both with the impact of not providing such information. DATA COLLECTION AND ANALYSIS: Two groups of two authors independently extracted data from the included studies and evaluated study quality. We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. We conducted meta-analyses of the results where possible. MAIN RESULTS: We identified 116 randomised trials which assessed the effectiveness of PROMs feedback in improving processes or outcomes of care, or both in a broad range of disciplines including psychiatry, primary care, and oncology. Studies were conducted across diverse ambulatory primary and secondary care settings in North America, Europe and Australasia. A total of 49,785 patients were included across all the studies. The certainty of the evidence varied between very low and moderate. Many of the studies included in the review were at risk of performance and detection bias. The evidence suggests moderate certainty that PROMs feedback probably improves quality of life (standardised mean difference (SMD) 0.15, 95% confidence interval (CI) 0.05 to 0.26; 11 studies; 2687 participants), and leads to an increase in patient-physician communication (SMD 0.36, 95% CI 0.21 to 0.52; 5 studies; 658 participants), diagnosis and notation (risk ratio (RR) 1.73, 95% CI 1.44 to 2.08; 21 studies; 7223 participants), and disease control (RR 1.25, 95% CI 1.10 to 1.41; 14 studies; 2806 participants). The intervention probably makes little or no difference for general health perceptions (SMD 0.04, 95% CI -0.17 to 0.24; 2 studies, 552 participants; low-certainty evidence), social functioning (SMD 0.02, 95% CI -0.06 to 0.09; 15 studies; 2632 participants; moderate-certainty evidence), and pain (SMD 0.00, 95% CI -0.09 to 0.08; 9 studies; 2386 participants; moderate-certainty evidence). We are uncertain about the effect of PROMs feedback on physical functioning (14 studies; 2788 participants) and mental functioning (34 studies; 7782 participants), as well as fatigue (4 studies; 741 participants), as the certainty of the evidence was very low. We did not find studies reporting on adverse effects defined as distress following or related to PROM completion. AUTHORS' CONCLUSIONS: PROM feedback probably produces moderate improvements in communication between healthcare professionals and patients as well as in diagnosis and notation, and disease control, and small improvements to quality of life. Our confidence in the effects is limited by the risk of bias, heterogeneity and small number of trials conducted to assess outcomes of interest. It is unclear whether   many of these improvements are clinically meaningful or sustainable in the long term. There is a need for more high-quality studies in this area, particularly studies which employ cluster designs and utilise techniques to maintain allocation concealment.

Development and Psychometric Validation of a Patient-Reported Outcome Measure for Arm Lymphedema: The LYMPH-Q Upper Extremity Module.

BACKGROUND: A multiphased mixed-methods study was performed to develop and validate a comprehensive patient-reported outcome measure (PROM) for arm lymphedema in women with breast cancer (i.e., the LYMPH-Q Upper Extremity Module). METHODS: Qualitative interviews (January 2017 and June 2018) were performed with 15 women to elicit concepts specific to arm lymphedema after breast cancer treatment. Data were audio-recorded, transcribed, and coded. Scales were refined through cognitive interviews (October and Decemeber 2018) with 16 patients and input from 12 clinical experts. The scales were field-tested (October 2019 and January 2020) with an international sample of 3222 women in the United States and Denmark. Rasch measurement theory (RMT) analysis was used to examine reliability and validity. RESULTS: The qualitative phase resulted in six independently functioning scales that measure arm symptoms, function, appearance, psychological function, and satisfaction with information and with arm sleeves. In the RMT analysis, all items in each scale had ordered thresholds and nonsignificant chi-square p values. For all the scales, the reliability statistics with and without extremes for the Person Separation Index were 0.80 or higher, Cronbach's alpha was 0.89 or higher, and the Intraclass Correlation Coefficients were 0.92 or higher. Lower (worse) scores on the LYMPH-Q Upper Extremity scales were associated with reporting of more severe arm swelling, an arm problem caused by cancer and/or its treatment, and wearing of an arm sleeve in the past 12 months. CONCLUSIONS: The LYMPH-Q Upper Extremity Module can be used to measure outcomes that matter to women with upper extremity lymphedema. This new PROM was designed using a modern psychometric approach and, as such, can be used in research and in clinical care.

Development and Psychometric Validation of the BREAST-Q Sensation Module for Women Undergoing Post-Mastectomy Breast Reconstruction.

BACKGROUND: Reconstructive techniques for restoring sensation to the breast after mastectomy continue to evolve. The BREAST-Q is a patient-reported outcome measure that can be used to evaluate outcomes of breast cancer treatments; however, it previously lacked scales to measure breast sensation. This paper outlines the development and validation of the BREAST-Q Sensation Module. METHODS: Phase 1 (January 2017 through December 2018) involved qualitative and cognitive interviews with women who had undergone breast reconstruction, as well as expert input, to develop and refine the scales. In phase 2 (March through June 2019), Love Research Army (LRA) members completed the scales, and Rasch Measurement Theory (RMT) analysis was performed to examine the reliability and validity of the scales. RESULTS: In this study, 36 qualitative and 7 cognitive interviews were conducted, and input from 18 experts was obtained. Three scales were developed to measure breast Symptoms (e.g., throbbing, burning, tingling), Sensation (e.g., feeling with light touch, through clothing, sexually), and Quality of Life impact of sensation loss. In phase 2, 1204 LRA members completed the scales. Data for each scale fit the RMT model. Reliability was high, with Person Separation Index, Cronbach alpha, and intraclass correlation coefficient values of 0.81 or higher (with and without extremes) for all three scales. Mean scores were higher (better) on the Symptoms and Quality of Life impact scales for the participants with unilateral (vs. bilateral) and autologous (vs. alloplastic) reconstruction, and for the participants who were farther out from their reconstruction. CONCLUSION: The BREAST-Q Sensation Module can be used alone or in conjunction with other BREAST-Q scales to inform clinical care and to evaluate outcomes of new surgical approaches to restoration of breast sensation.

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

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