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.

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.

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 (PROM). The BODY-Q is a PROM developed to measure changes in HRQL and satisfaction with appearance in patients with BS and BCS. METHODS: Prospective BODY-Q data were collected from six European countries (Denmark, 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 5,620 patients. BS initially led to improved HRQL and appearance scores throughout the first post-bariatric 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. CONCLUSION: Patients who underwent BCS maintained the improvement in HRQL and satisfaction with appearance in contrast to patients who only underwent BS, who reported a decline in scores 1-2 years postoperatively. Our results emphasize the pivotal role that BCS plays in the completion of the weight loss trajectory.

Evaluation of DermSat-7 for Assessing Treatment Satisfaction in Patients with Acne.

Importance: Treatment satisfaction is important to achieving therapeutic success in patients with inflammatory dermatological diseases, such as acne. Objective: To evaluate the structural validity, internal consistency, and construct validity of the DermSat-7, a questionnaire-based measure of treatment satisfaction, in patients with acne seen in routine clinical practice. Design, Setting, and Participants: This cross-sectional study included adults with acne who were fluent in English and treated at an outpatient clinic at Brigham and Women's Hospital between July 2022 and May 2023. At each visit, patients completed a self-administered, patient-reported outcome questionnaire, including a patient global assessment (PGA) of their acne severity and the DermSat-7. The DermSat-7 consists of 7 items assessing 3 domains of treatment: effectiveness (3 items), convenience (3 items), and overall satisfaction (1 item). At subsequent visits, patients were asked an anchor item related to change in disease severity ("How has your acne changed compared to your last visit?") that was scored on a 7-point scale (-3 = much worse to 3 = much better). Also at each visit, a dermatologist completed the Comprehensive Acne Severity Scale (CASS). Main Outcomes and Measures: The main outcomes were structural validity (assessed by factor analysis), internal consistency (assessed by Cronbach α), and construct validity (assessed using linear regression models and Pearson correlation coefficients). Results: The analysis included 142 patients with acne (mean [SD] age, 25.1 [5.1] years; 96 females [67.6%]) taking acne medication who completed the DermSat-7. Exploratory factor and confirmatory factor analysis supported the unidimensionality of the 3 DermSat-7 domains. Cronbach α values of 0.89 and 0.80 supported good internal consistency in the effectiveness and convenience domains, respectively. Known-groups validity was supported by increasing DermSat-7 effectiveness and overall satisfaction scores with increasing levels of positive change in disease severity (linear regression coefficient, 7.51; 95% CI, 4.94-10.08; P < .001). Construct validity was further supported by moderate correlations with the anchor, PGA, and CASS scores (effectiveness domain: anchor r = 0.567, PGA r = -0.538, and CASS r = -0.485; overall satisfaction domain: anchor r = 0.467, PGA r = -0.486, and CASS r = -0.489). Conclusion and Relevance: This cross-sectional study found that the DermSat-7 may be an effective tool for measuring treatment satisfaction, particularly effectiveness and overall satisfaction domains, among patients with acne. Further research is needed to examine additional measurement properties of the DermSat-7, such as content validity and interpretability, as well as to validate the DermSat-7 in other populations of patients with acne.

Social Determinants of Health Needs and Health-related Quality of Life Among Surgical Patients: A Retrospective Analysis of 8512 Patients.

OBJECTIVE: To assess associations between social determinants of health (SDOH) needs and health-related quality of life (HRQOL) among surgical patients. BACKGROUND: Despite the profound impact of SDOH on health outcomes, studies examining the effect of SDOH needs on HRQOL among surgical patients are limited. METHODS: A retrospective study was conducted using responses from the SDOH needs assessment and the Patient-Reported Outcomes Measurement Information Systems Global Health instrument of adults seen in surgical clinics at a single institution. Patient characteristics including socioeconomic status (insurance type, education level, and employment status) were extracted. Stepwise multivariable logistic regression analyses were performed to identify independent predictors of global health scores. RESULTS: A total of 8512 surgical patients (mean age: 55.6±15.8 years) were included. 25.2% of patients reported one or more SDOH needs. The likelihood of reporting at least one SDOH need varied by patient characteristics and socioeconomic status variables. In fully adjusted regression models, food insecurity [odds ratio (OR), 1.53; 95% CI, 1.38-1.70 and OR, 1.49; 95% CI, 1.22-1.81, respectively], housing instability (OR, 1.27; 95% CI, 1.12-1.43 and OR, 1.39; 95% CI, 1.13-1.70, respectively) lack of transportation (OR, 1.46; 95% CI, 1.27-1.68 and OR, 1.25; 95% CI, 1.00-1.57, respectively), and unmet medication needs (OR, 1.31; 95% CI, 1.13-1.52 and OR, 1.61; 95% CI, 1.28-2.03, respectively) were independent predictors of poor physical and mental health. CONCLUSIONS: SDOH needs are independent predictors of poor patient-reported physical and mental health among surgical patients. Assessing and addressing SDOH needs should be prioritized in health care settings and by policymakers to improve HRQOL.

BODY-Q Normative Scores: Psychometric Validation of the BODY-Q in the General Population in Europe and North America.

Background: BODY-Q is a rigorously developed patient-reported outcome measure designed to measure outcomes of weight loss and body contouring patients. To allow interpretation and comparison of BODY-Q scores across studies, normative BODY-Q values were generated from the general population. The aim of this study was to examine the psychometric properties of BODY-Q in the normative population. Methods: Data were collected using two crowdsourcing platforms (Prolific and Amazon Mechanical Turk) in 12 European and North American countries. Rasch measurement theory (RMT) was used to examine reliability and validity of BODY-Q scales. Results: RMT analysis supported the psychometric properties of BODY-Q in the normative sample with ordered thresholds in all items and nonsignificant chi-square values for 167 of 176 items. Reliability was high with person separation index of greater than or equal to 0.70 in 20 of 22 scales and Cronbach alpha values of greater than or equal to 0.90 in 17 of 22 scales. Mean scale scores measuring appearance, health-related quality of life, and eating-related concerns scales varied as predicted across subgroups with higher scores reported by participants who were more satisfied with their weight. Analysis to explore differential item functioning by sample (normative versus field-test) flagged some potential issues, but subsequent comparison of adjusted and unadjusted person estimates provided evidence that the scoring algorithm worked equivalently for the normative sample as in the field-test samples. Conclusions: The BODY-Q scales showed acceptable reliability and validity in the normative sample. The normative values can be used as reference in research and clinical practice in combination with local estimates for parallel analysis and comparison.

Ensuring patient centeredness in upper extremity lymphedema research: Identifying patient-prioritized agenda and preferences.

PURPOSE: To elicit a patient-prioritized agenda and preferences for upper extremity lymphedema (LE) research. METHODS: Focus group sessions (FGs) were conducted with English-speaking, adult women (18 years and older) with breast cancer-related LE (BCRL) seeking conservative or surgical care at two tertiary cancer centers in Ontario, Canada. An interview guide was used; women were asked to describe health-related quality of life (HRQL) outcomes that mattered the most to them, followed by their preferences for research study design and for providing patient-reported outcomes measure (PROM) data. Inductive content analysis was used to identify themes and subthemes. RESULTS: A total of 16 women participated in 4 FG sessions (55 ± 9.5 years) and described the impact of LE on their appearance, physical, psychosocial, and sexual well-being. Women emphasized that psychosocial well-being was often not discussed in clinical care and that they were poorly informed of LE risk and care options. Most women said that they would not be willing to be randomized to surgical versus conservative management of LE. They also expressed a preference to complete PROM data electronically. All women emphasized the value of having an open text option alongside PROMs to expand on their concerns. CONCLUSION: Patient centeredness is key to generating meaningful data and ensuring ongoing engagement in clinical research. In LE, comprehensive PROMs that measure a range of HRQL concerns, especially psychosocial well-being, should be considered. Women with BCRL are reluctant to be randomized to conservative care when a surgical option is available, resulting in implications for planning trial sample size and recruitment.

Can we do better at measuring patient-reported outcomes after cranioplasty? A systematic review.

Measuring quality of life (QOL) after cranioplasty is increasingly evident as a necessary component of patient-centered care. For data to be useful in clinical decision-making and approval of new therapies, studies must utilize valid and reliable instruments. Our objective was to critically appraise studies evaluating QOL in adult cranioplasty patients and determine validity and relevance of the patient-reported outcome measures (PROMs) used. Electronic databases of PubMed, Embase, CINAHL, and PsychINFO were used to identify PROMs measuring QOL in adult patients with cranioplasty. The methodological approach, cranioplasty outcomes, and domains measured by the PROMs were extracted and summarized descriptively. A content analysis of the identified PROMs was completed to identify the concepts measured. From 2236 articles identified, 17 articles containing eight QOL PROMs met the inclusion criteria. None of the PROMs was specifically validated or developed for adults undergoing cranioplasty. The QOL domains included physical health, psychological health, social health, and general QOL. These four domains encompassed 216 total items among the PROMs. Appearance was only assessed in two PROMs. To our knowledge, there are currently no validated PROMs that comprehensively measure appearance, facial function, and adverse effects in adults undergoing cranioplasty. There is an urgent need to develop PROMs to measure QOL outcomes rigorously and comprehensively in this patient population to inform clinical care, research, and quality improvement initiatives. Findings from this systematic review will be used to derive an outcome instrument containing important concepts related to QOL in patients who undergo cranioplasty.

Development and Content Validity of a Novel Patient-Reported Outcome Measure for Total Laryngectomy: The LARY-Q.

OBJECTIVES: To develop a patient-reported outcomes measure (PROM) for total laryngectomy. STUDY DESIGN: Qualitative interviews with a purposive sample of patients with total laryngectomy, followed by cognitive debriefing interviews with patients and expert feedback. METHODS: Concept elicitation was performed using in-depth qualitative interviews with a purposive sample of patients who had undergone total laryngectomy. Patients were recruited from head and neck surgery and speech-language pathology clinics as well as via laryngectomy support groups. Interviews were conducted, recorded, transcribed, and coded, resulting in a conceptual framework and item pool. Using the item pool, preliminary scales were drafted. The scales were revised iteratively over 5 rounds using feedback from cognitive interviews with patients and multi-institutional and multi-disciplinary expert feedback. RESULTS: A total of 15 patients with total laryngectomy (mean age 68 years, range 57-79) were interviewed resulting in 1555 codes. The codes were used to form a conceptual framework grouped into top-level domains of stoma, function, health-related quality of life, devices, and experience of care. Items were used to form 15 preliminary scales that were revised over five rounds of cognitive debriefing interviews (n = 9 patients) and expert feedback (n = 17 experts). The field-test version of the LARY-Q has 18 scales and 277 items in total. CONCLUSIONS: The LARY-Q is a novel PROM designed to assess outcomes associated with total laryngectomy. The next step involves a field test study with a heterogenous sample of patients to assess the psychometric properties of the LARY-Q and perform item reduction.

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.

Health state utility values in patients undergoing chest masculinization surgery.

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

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.

General population normative scores for interpreting the BODY-Q.

The BODY-Q is a patient-reported outcome measure used to assess outcomes in patients undergoing weight loss and/or body contouring surgery (BC) following massive weight loss. Normative values for the BODY-Q are needed to improve data interpretation and enable comparison. Thus, the aim of this study was to determine normative values for the BODY-Q. Participants were recruited internationally through two crowdsourcing platforms. The participants were invited to complete the BODY-Q scales through an URL link provided within the crowdsourcing platforms. General linear analyses were performed to compare normative means between countries and continents adjusted for relevant covariates. Normative reference values were stratified by age, body mass index (BMI), and gender. The BODY-Q was completed by 4051 (2052 North American and 1999 European) participants. The mean age was 36 years (±14.7 SD) and ranged from 17 to 76 years, the mean BMI was 26.4 (±6.7 SD) kg/m2 , and the sample consisted of 1996 (49.3%) females and 2023 (49.9%) males. Younger age and higher BMI were negatively associated with all BODY-Q scales (p < .001). This study provides normative values for the BODY-Q scales to aid in the interpretation of BODY-Q scores in research and clinical practise. These values enable us to understand the impact of weight loss and BC on patients' lives.

Qualitative study informing the development and content validity of the HAND-Q: a modular patient-reported outcome measure for hand conditions.

OBJECTIVES: The purpose of this study was to identify and understand the issues that are relevant to patients with hand conditions. The data were used to develop a patient-reported outcome measure (PROM) for adults with hand conditions (HAND-Q) and refine it with input from patients and clinician experts. DESIGN: Semistructured qualitative interviews were used to understand what matters to patients. Cognitive debriefing was used to refine preliminary HAND-Q scales. SETTING: Hand clinics in tertiary healthcare centres in Canada, Australia and USA. PARTICIPANTS: Eligible participants were English-speaking adults who had experienced hand surgery in the preceding 12 months and were at least 4 weeks post-hand surgery A total of 62 in-depth interviews (females, n=34; mean age=65 years) were conducted to develop an item pool and draft the HAND-Q scales. The preliminary scales were refined through cognitive debriefing interviews with 20 participants and feedback from 25 clinician experts. All interviews were audiorecorded, transcribed verbatim and coded using a line-by-line approach. RESULTS: Qualitative data were organised into two top-level domains of health-related quality of life and satisfaction with treatment outcomes. The scales were refined iteratively, and the field-test version included 319 unique items and 20 independently functioning scales. CONCLUSIONS: The HAND-Q is a comprehensive PROM developed using extensive patient and clinician expert input, following established guidelines for PROM development and validation. In the next phase, the psychometric properties of the HAND-Q will be established in an international field test, following which the HAND-Q will be available for use in clinical research and practice .

Understanding Breast Implant-Associated Illness: A Delphi Survey Defining Most Frequently Associated Symptoms.

BACKGROUND: Increased understanding of the constellation of symptoms referred to as breast implant illness is necessary to better address patient concerns, provide evidence-based care, and inform prospective patients about potential risks. The aim of this study was to reach consensus on the symptoms most frequently associated with breast implant illness, which will subsequently inform the development of a symptom severity scale. METHODS: A literature search of peer-reviewed and gray literature was performed to identify a comprehensive list of symptoms associated with breast implant illness. This was followed by an online, three-round, modified Delphi survey where the list of symptoms was reviewed by an international panel to determine the top 20, 10, and five symptoms associated with breast implant illness. A virtual meeting of panelists was held to reach consensus on the symptoms to be included in a symptom severity scale. RESULTS: A total of 44 symptoms were identified through the literature search. The modified Delphi survey panel consisted of patient research partners [n = 9 (34.6 percent)], plastic surgeons [n = 10 (38.5 percent)], researchers [n = 6 (23.1 percent)], and a member of the U.S. Food and Drug Administration [n = 1 (3.8 percent)]. The response rates of round 1, 2, and 3 were 85, 96, and 100 percent, respectively. Consensus was reached on the top 19 and top six symptoms to be included in long and short forms of a symptom severity scale. CONCLUSIONS: There was a high level of agreement on the symptoms to be included in a symptom severity scale. The next steps include conducting in-depth qualitative interviews with women with these symptoms and breast implants to understand the experience and impact of these symptoms and develop the preliminary scale.

Implementing patient-reported outcomes in routine clinical care for diverse and underrepresented patients in the United States.

BACKGROUND: Patient-reported outcomes (PROs) are used increasingly in routine clinical care and inform policies, reimbursements, and quality improvement. Less is known regarding PRO implementation in routine clinical care for diverse and underrepresented patient populations. OBJECTIVE: This review aims to identify studies of PRO implementation in diverse and underrepresented patient populations, elucidate representation of clinical specialties, assess implementation outcomes, and synthesize patient needs, concerns, and preferences. METHODS: MEDLINE, Embase, Web of Science, CINAHL, and PsycINFO were searched September 2021 for studies aiming to study PRO implementation in diverse and underrepresented patient populations within the United States. Studies were screened and data extracted by three independent reviewers. Implementation outcomes were assessed according to Proctor et al. taxonomy. A descriptive analysis of data was conducted. RESULTS: The search yielded 8,687 records, and 28 studies met inclusion criteria. The majority were observational cohort studies (n = 21, 75%) and conducted in primary care (n = 10, 36%). Most studies included majority female (n = 19, 68%) and non-White populations (n = 15, 54%), while fewer reported socioeconomic (n = 11, 39%) or insurance status (n = 9, 32.1%). Most studies assessed implementation outcomes of feasibility (n = 27, 96%) and acceptability (n = 19, 68%); costs (n = 3, 11%), penetration (n = 1, 4%), and sustainability (n = 1, 4%) were infrequently assessed. CONCLUSION: PRO implementation in routine clinical care for diverse and underrepresented patient populations is generally feasible and acceptable. Research is lacking in key clinical specialties. Further work is needed to understand how health disparities drive PRO implementation outcomes.

Patient-reported outcomes (PROs) allow doctors and researchers to understand the patient perspective, such as how they are doing physically, mentally, or socially. When used, PROs can improve health and increase satisfaction of patients. Many clinics and hospitals are interested in using PROs in everyday care. Doctors, hospitals, and insurance companies are also using information from PROs to decide if the care they give is good quality. Unfortunately, certain groups of patients, such as racial and ethnic minorities and patients with low income, report worse PROs. Because of these differences, it will be important to make sure that PROs are being collected from all people, but not much is known regarding how this has been done. This study demonstrates what is known so far with regard to using PROs in everyday clinical care for these diverse patient groups. Findings from this study show that PROs can be successfully collected, but more work is needed in certain medical fields, and some types of patients have specific needs, concerns, or preferences with regard to PRO collection.

A Systematic Literature Review of Health Utility Values in Breast Cancer.

BACKGROUND: Health utility values (HUVs) are important inputs to the cost-utility analysis of breast cancer interventions. PURPOSE: Provide a catalog of breast cancer-related published HUVs across different stages of breast cancer and treatment interventions. DATA SOURCES: Systematic searches of MEDLINE, MEDLINE In-Process, EMBASE, Web of Science, CINAHL, PsycINFO, EconLit, and Cochrane databases (2005-2017). STUDY SELECTION: Studies published in English that reported mean or median HUVs using direct or indirect methods of utility elicitation for breast cancer. DATA EXTRACTION: Independent reviewers extracted data on a preestablished and piloted form; disagreements were resolved through discussion. DATA ANALYSIS: Mixed-effects meta-regression using restricted maximum likelihood modeling was conducted for intervention type, stage of breast cancer, and typical clinical and treatment trajectory of breast cancer patients to assess the effect of study characteristics (i.e., sample size, utility elicitation method, and respondent type) on HUVs. DATA SYNTHESIS: Seventy-nine studies were included in the review. Most articles (n = 52, 66%) derived HUVs using the EQ-5D. Patients with advanced-stage breast cancer (range, 0.08 to 0.82) reported lower HUVs as compared with patients with early-stage breast cancer (range, 0.58 to 0.99). The meta-regression analysis found that undergoing chemotherapy and surgery and radiation, being diagnosed with an advanced stage of breast cancer, and recurrent cancer were associated with lower HUVs. The members of the general public reported lower HUVs as compared with patients. LIMITATIONS: There was considerable heterogeneity in the study population, health states assessed, and utility elicitation methods. CONCLUSION: This review provides a catalog of published HUVs related to breast cancer. The substantial heterogeneity in the health utility studies makes it challenging for researchers to choose which HUVs to use in cost-utility analyses for breast cancer interventions.

Cost-effectiveness of eltrombopag vs intravenous immunoglobulin for the perioperative management of immune thrombocytopenia.

Eltrombopag has been shown to be noninferior to intravenous immunoglobulin (IVIG) for improving perioperative platelet counts in patients with immune thrombocytopenia (ITP) in a randomized trial; thus, cost is an important factor for treatment and policy decisions. We used patient-level data from the trial to conduct a cost-effectiveness analysis comparing perioperative eltrombopag 50 mg daily starting dose, with IVIG 1 or 2 g/kg (according to local practice) from a Canadian public health care payer's perspective over the observation period, from preoperative day 21 to postoperative day 28. Resource utilization data were obtained from the trial data (eltrombopag, n = 38; IVIG, n = 36), and unit costs were collected from the Ontario Schedule of Benefits, Ontario Drug Formulary, and secondary sources. All costs were adjusted to 2020 Canadian dollars. We calculated the incremental cost per patient for all patients randomized. Uncertainty was addressed using nonparametric bootstrapping. The use of perioperative eltrombopag for patients with ITP resulted in a cost-saving of $413 Canadian per patient. Compared with IVIG, the probability of eltrombopag being cost effective was 70% even with no willingness to pay. In a sensitivity analysis based on IVIG dose, we found that with the higher dose of IVIG (2 g/kg), eltrombopag saved $2,714 per patient, whereas with the lower dose of IVIG (1 g/kg), eltrombopag had a higher mean cost of $562 per patient. In summary, based on data from the randomized trial that demonstrated noninferiority, the use of eltrombopag for the management of ITP in the perioperative setting was less costly than IVIG.