Substantial health and economic burden of COVID-19 during the year after acute illness among US adults at high risk of severe COVID-19.

BACKGROUND: Post-COVID conditions encompass a range of long-term symptoms after SARS-CoV-2 infection. The potential clinical and economic burden in the United States is unclear. We evaluated diagnoses, medications, healthcare use, and medical costs before and after acute COVID-19 illness in US patients at high risk of severe COVID-19. METHODS: Eligible adults were diagnosed with COVID-19 from April 1 to May 31, 2020, had ≥ 1 condition placing them at risk of severe COVID-19, and were enrolled in Optum's de-identified Clinformatics® Data Mart Database for ≥ 12 months before and ≥ 13 months after COVID-19 diagnosis. Percentages of diagnoses, medications, resource use, and costs were calculated during baseline (12 months preceding diagnosis) and the post-acute phase (12 months after the 30-day acute phase of COVID-19). Data were stratified by age and COVID-19 severity. RESULTS: The cohort included 19,558 patients (aged 18-64 y, n = 9381; aged ≥ 65 y, n = 10,177). Compared with baseline, patients during the post-acute phase had increased percentages of blood disorders (16.3%), nervous system disorders (11.1%), and mental and behavioral disorders (7.7%), along with increases in related prescriptions. Overall, there were substantial increases in inpatient and outpatient healthcare utilization, along with a 23.0% increase in medical costs. Changes were greatest among older patients and those admitted to the intensive care unit for acute COVID-19 but were also observed in younger patients and those who did not require COVID-19 hospitalization. CONCLUSIONS: There is a significant clinical and economic burden of post-COVID conditions among US individuals at high risk for severe COVID-19.

Substantial health and economic burden of COVID-19 during the year after acute illness among US adults not at high risk of severe COVID-19.

BACKGROUND: Patients recovering from SARS-CoV-2 infection and acute COVID-19 illness can experience a range of long-term post-acute effects. The potential clinical and economic burden of these outcomes in the USA is unclear. We evaluated diagnoses, medications, healthcare utilization, and medical costs before and after acute COVID-19 illness in US patients who were not at high risk of severe COVID-19. METHODS: This study included eligible adults who were diagnosed with COVID-19 from April 1 to May 31, 2020, who were 18 - 64 years of age, and enrolled within Optum's de-identified Clinformatics® Data Mart Database for 12 months before and 13 months after COVID-19 diagnosis. Patients with any condition or risk factor placing them at high risk of progression to severe COVID-19 were excluded. Percentages of diagnoses, medications, healthcare utilization, and costs were calculated during baseline (12 months preceding diagnosis) and the post-acute phase (12 months after the 30-day acute phase of COVID-19). Data were stratified into 3 cohorts according to disposition during acute COVID-19 illness (i.e., not hospitalized, hospitalized without intensive care unit [ICU] admission, or admitted to the ICU). RESULTS: The study included 3792 patients; 56.5% of patients were men, 44% were White, and 94% did not require hospitalization. Compared with baseline, patients during the post-acute phase had percentage increases in the diagnosis of the following disorders: blood (166%), endocrine and metabolic (123%), nervous system (115%), digestive system (76%), and mental and behavioral (75%), along with increases in related prescriptions. Substantial increases in all measures of healthcare utilization were observed among all 3 cohorts. Total medical costs increased by 178% during the post-acute phase. Those who were hospitalized with or without ICU admission during the acute phase had the greatest increases in comorbidities and healthcare resource utilization. However, the burden was apparent across all cohorts. CONCLUSIONS: As evidenced by resource use in the post-acute phase, COVID-19 places a significant long-term clinical and economic burden among US individuals, even among patients whose acute infection did not merit hospitalization.

Health-related quality of life in mild-to-moderate COVID-19 in the UK: a cross-sectional study from pre- to post-infection.

BACKGROUND: The aim of this study was to estimate the impact of mild-to-moderate COVID-19 on health-related quality of life (HRQoL) over time among individuals in the United Kingdom, adding to the evidence base that had focussed on severe COVID-19. METHODS: A bespoke online survey was administered to individuals who self-reported a positive COVID-19 test. An amended version of a validated generic HRQoL instrument (EQ-5D-5L) was used to measure HRQoL retrospectively at different timepoints over the course of an infection: pre-COVID-19, acute COVID-19, and long COVID. In addition, HRQoL post-COVID-19 was captured by the original EQ-5D-5L questionnaire. A mixed-effects model was used to estimate changes in HRQoL over time, adjusted for a range of variables correlated with HRQoL. RESULTS: The study recruited 406 participants: (i) 300 adults and 53 adolescents with mild-to-moderate COVID-19 who had not been hospitalised for COVID-19 during acute COVID-19, and (ii) 53 adults who had been hospitalised for COVID-19 in the acute phase and who had been recruited for validation purposes. Data were collected between January and April 2022. Among participants included in the base-case analysis, EQ-5D-5L utility scores were lower during both acute COVID-19 (ß=-0.080, p = 0.001) and long COVID (ß=-0.072, p < 0.001) compared to pre COVID-19. In addition, EQ-5D-5L utility scores post-COVID-19 were found to be similar to the EQ-5D-5L utility scores before COVID-19, including for patients who had been hospitalised for COVID-19 during the acute phase or for those who had experienced long COVID. Moreover, being hospitalised in the acute phase was associated with additional utility decrements during both acute COVID-19 (ß=-0.147, p = 0.026) and long (ß=-0.186, p < 0.001) COVID. CONCLUSION: Patients perceived their HRQoL to have varied significantly over the course of a mild-to-moderate COVID-19 infection. However, HRQoL was found to return to pre-COVID-19 levels, even for patients who had been hospitalised for COVID-19 during the acute phase or for those who had experienced long COVID.

Use of the Postacute Sequelae of COVID-19 Diagnosis Code in Routine Clinical Practice in the US.

Importance: A new International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code (U09.9 Post COVID-19 condition, unspecified) was introduced by the Centers for Disease Control and Prevention on October 1, 2021. Objective: To examine the use of the U09.9 code and describe concurrently diagnosed conditions to understand physician use of this code in clinical practice. Design, Setting, and Participants: This cohort study of US patients with an ICD-10-CM code for post-COVID-19 condition used deidentified patient-level claims data aggregated by HealthVerity. Children and adolescents (aged 0-17 years) and adults (aged 18-64 and ≥65 years) with a post-COVID-19 condition code were identified between October 1, 2021, and January 31, 2022. To identify a prior COVID-19 diagnosis, 3 months of continuous enrollment (CE) before the post-COVID-19 diagnosis date was required. Main Outcomes and Measures: Presence of the ICD-10-CM U09.9 code. Results: There were 56 143 patients (7723 female patients [61.2%]; mean [SD] age, 47.6 [19.2] years) with a post-COVID-19 diagnosis code, with cases increasing in mid-December 2021 following the trajectory of the Omicron case wave by 3 to 4 weeks. The analysis cohort included 12 622 patients after the 3-month preindex CE criteria was applied. Among this cohort, the median (IQR) age was 49 (35-61) years; however, 1080 (8.6%) were pediatric patients. The U09.9 code was used most often in the outpatient setting, although 305 older adults (14.0%) were inpatients. Only 698 patients (5.5%) had at least 1 of the 5 codes listed as possible concurrent conditions in the coding guidance. Only 8879 patients (70.4%) had a documented acute COVID-19 diagnosis code (569 [52.7%] among children), and the median (IQR) time between acute COVID-19 and post-COVID-19 diagnosis codes was 56 (21-200) days. The most common concurrently coded conditions varied by age; children experienced COVID-19-like symptoms (eg, 207 [19.2%] had cough and 115 [10.6%] had breathing abnormalities), while 459 older adults aged 65 years or older (21.1%) experienced respiratory failure and 189 (8.7%) experienced viral pneumonia. Conclusions and Relevance: This retrospective cohort study found patients with a post-COVID-19 ICD-10-CM diagnosis code following the acute phase of COVID-19 disease among patients of all ages in clinical practice in the US. The use of the U09.9 code encompassed a wide range of conditions. It will be important to monitor how the use of this code changes as the pandemic continues to evolve.

Real-world retrospective analysis of patient characteristics, healthcare resource utilization, costs, and treatment patterns among unvaccinated adults with COVID-19 diagnosed in outpatient settings in the United States.

AIMS: This retrospective analysis of the Optum Clinformatics Data Mart database evaluated US patient characteristics, healthcare resource utilization (HCRU), costs, and treatment patterns among unvaccinated adults with outpatient-diagnosed COVID-19 to quantify US economic burden. MATERIALS AND METHODS: The index event was the earliest outpatient diagnosis of confirmed COVID-19 from May 1 to December 10, 2020. Patients had 12 months' continuous enrollment before and were followed for ≥60 days after index date until insurance dis-enrollment or study end. RESULTS: 236,589 patients had outpatient-diagnosed COVID-19 (7,692 with and 228,897 without subsequent COVID-19-related inpatient admission >48 h post-diagnosis). The median age was 51 years (≥65 years, 30.0%); 72.4% had ≥1 risk factor. Patients with versus without subsequent inpatient admission were more often male, older, Black/Hispanic, and had comorbidities/risk factors. With a median follow-up of 162 days, patients had a median of 1 COVID-19-related outpatient visit (with inpatient admission, 5 outpatient visits). Those with inpatient admission had a median of 1 COVID-19-related inpatient visit (median length of stay [LOS], 6 days), 33.3% were admitted to intensive care (median LOS, 8 days), 8.4%, 7.1%, and 13.3% received invasive mechanical ventilation, noninvasive mechanical ventilation, and supplemental oxygen, respectively; 13.5% experienced readmission. Inpatient mortality was 6.0% (0.3% for nonhospitalized patients). Antithrombotic therapy, antibiotics, corticosteroids, and remdesivir use increased among patients with inpatient admission versus without. Median total COVID-19-related non-zero medical costs were $208 for patients without inpatient admission (with inpatient admission, $39,187). LIMITATIONS: Results reflect the circulating SARS-CoV-2 and treatment landscape during the study period. Requirements for continuous enrollment could have biased the population. Cost measurements may have included allowed (typically higher) and charge amounts. CONCLUSIONS: Given the numbers of the US population who are still not fully vaccinated and the evolving epidemiology of the pandemic, this study provides relevant insights on real-world treatment patterns, HCRU, and the cost burden of outpatient-diagnosed COVID-19.

Incidence and prevalence of psoriatic arthritis in patients with psoriasis stratified by psoriasis disease severity: Retrospective analysis of an electronic health records database in the United States.

BACKGROUND: Among patients in the United States with psoriasis (PsO), limited data exist on the incidence and prevalence of psoriatic arthritis (PsA) based on disease severity. OBJECTIVE: To assess the incidence, prevalence, and predictors of PsA among patients with PsO stratified by PsO severity using treatment type. METHODS: Incidence of PsA per 100 PsO patient-years (PY) and prevalence were assessed using the Optum electronic health records database. Incidence was assessed from PsO diagnosis and 1 year after PsO diagnosis overall and stratified by mutually exclusive treatment classes as a severity surrogate. RESULTS: The overall incidence of PsA was 2.9 (95% CI, 2.9-3.0) events per 100 PY. The incidence (95% CI) by severity surrogate was 2.1 (2.1-2.1), 9.9 (9.5-10.4), and 17.6 (16.9-18.3) events per 100 PY for patients with mild, moderate, and severe PsO as determined by receiving nonsystemics, nonbiologic systemic therapy, and biologics, respectively. When excluding patients diagnosed with PsA 1 year after PsO diagnosis, overall incidence was lower (1.7 [95% CI, 1.6-1.7] events per 100 PY), with similar trends for treatment-severity surrogates. LIMITATIONS: Results may not be generalizable to a wider population. CONCLUSION: The risk of developing PsA increased with disease severity and was highest in patients with the most severe PsO.

Incidence of Psoriatic Arthritis in Patients with Skin Psoriasis and Associated Risk Factors: A Retrospective Population-based Cohort Study in Swedish Routine Clinical Care.

The incidence of psoriatic arthritis in patients with psoriasis is unclear; existing estimates differ by a factor of ten. Complete population-level data is needed to provide accurate estimates with high confidence. A total of 123,814 adults with psoriasis, free from pre-existing psoriatic arthritis, were identified in population-based data from secondary care in Sweden during 2007 to 2017. Incidence was calculated as the number of psoriatic arthritis diagnosis events per 100 patient-years. Time to diagnosis was assessed using cumulative incidence and Cox proportional hazards models to identify risk factors. Incidence of psoriatic arthritis in patients with psoriasis was 1.69 per 100 patient-years (95% confidence interval 1.65-1.72) overall, and 1.48, 3.00, and 5.49 per 100 patient-years in patients with mild, moderate and severe psoriasis, respectively. Risk of psoriatic arthritis was 3.2 times higher amongst patients with severe psoriasis compared with mild disease. Dermatologists should regularly assess risk factors for psoriatic arthritis in clinical practice in order to improve the detection of psoriatic arthritis.

Defining Patient Engagement in Research: Results of a Systematic Review and Analysis: Report of the ISPOR Patient-Centered Special Interest Group.

OBJECTIVES: Lack of clarity on the definition of "patient engagement" has been highlighted as a barrier to fully implementing patient engagement in research. This study identified themes within existing definitions related to patient engagement and proposes a consensus definition of "patient engagement in research." METHODS: A systematic review was conducted to identify definitions of patient engagement and related terms in published literature (2006-2018). Definitions were extracted and qualitatively analyzed to identify themes and characteristics. A multistakeholder approach, including academia, industry, and patient representation, was taken at all stages. A proposed definition is offered based on a synthesis of the findings. RESULTS: Of 1821 abstracts identified and screened for eligibility, 317 were selected for full-text review. Of these, 169 articles met inclusion criteria, from which 244 distinct definitions were extracted for analysis. The most frequently defined terms were: "patient-centered" (30.5%), "patient engagement" (15.5%), and "patient participation" (13.4%). The majority of definitions were specific to the healthcare delivery setting (70.5%); 11.9% were specific to research. Among the definitions of "patient engagement," the most common themes were "active process," "patient involvement," and "patient as participant." In the research setting, the top themes were "patient as partner," "patient involvement," and "active process"; these did not appear in the top 3 themes of nonresearch definitions. CONCLUSION: Distinct themes are associated with the term "patient engagement" and with engagement in the "research" setting. Based on an analysis of existing literature and review by patient, industry, and academic stakeholders, we propose a scalable consensus definition of "patient engagement in research."

Psychosocial and Sexual Well-Being Following Nipple-Sparing Mastectomy and Reconstruction.

Nipple-sparing mastectomy (NSM) is considered an oncologically safe option for select patients. As many patients are candidates for nipple-sparing or skin-sparing mastectomy (SSM), reliable patient-reported outcome data are crucial for decision-making. The objective of this study was to determine whether patient satisfaction and/or health-related quality of life (HRQOL) were improved by preservation of the nipple with NSM compared to SSM and nipple reconstruction. Subjects were identified from a prospectively maintained database of patients who completed the BREAST-Q following mastectomy and breast reconstruction between March and October 2011 at Memorial Sloan Kettering Cancer Center. Fifty-two patients underwent NSM followed by immediate expander-implant reconstruction. A comparison group consisted of 202 patients who underwent SSM followed by immediate expander-implant reconstruction and later nipple reconstruction. HRQOL and satisfaction domains as measured by BREAST-Q scores were compared in multivariate linear regression analyzes that controlled for potential confounding factors. NSM patients reported significantly higher scores in the psychosocial (p = 0.01) and sexual well-being (p = 0.02) domains compared to SSM patients. There was no significant difference in the BREAST-Q physical well-being, satisfaction with breast, or satisfaction with outcome domains between the NSM and SSM groups. NSM is associated with higher psychosocial and sexual well-being compared to SSM and nipple reconstruction. Preoperative discussion of such HRQOL outcomes with patients may facilitate informed decision-making and realistic postoperative expectations.

Patient experiences and outcomes following facial skin cancer surgery: A qualitative study.

Early melanoma and non-melanoma skin cancer of the facial area are primarily treated with surgery. Little is known about the outcomes of treatment for facial skin cancer patients. The objective of the study was to identify concerns about aesthetics, procedures and health from the patients' perspective after facial skin surgery. Semi-structured in-depth interviews were conducted with 15 participants. Line-by-line coding was used to establish categories and develop themes. We identified five major themes on the impact of skin cancer surgery: appearance-related concerns; psychological (e.g., fear of new cancers or recurrence); social (e.g. impact on social activities and interaction); physical (e.g. pain and swelling) concerns and satisfaction with the experience of care (e.g., satisfaction with surgeon). The priority of participants was the removal of the facial skin cancer, as this reduced their overall worry. The aesthetic outcome was secondary but important, as it had important implications on the participants' social and psychological functioning. The participants' experience with the care provided by the surgeon and staff also contributed to their satisfaction with their treatment. This conceptual framework provides the basis for the development of a new patient-reported outcome instrument.

Assessing Patient-Reported Outcomes Following Orthognathic Surgery and Osseous Genioplasty.

Primary outcomes for orthognathic surgery and genioplasty patients include satisfaction with appearance, improved motor function, and enhanced quality of life. The goal of this study was to assess outcomes among patients undergoing these procedures, and to highlight the potential use of FACE-Q instrument for use in patients with dentofacial deformities. A total of 56 patients presenting for orthognathic surgery and/or osseous genioplasty completed the FACE-Q during preoperative and/or at postoperative visits. FACE-Q scores increased following surgery in satisfaction with facial appearance overall (+24.5, P < 0.01), satisfaction with lower face and jawline (+40.7, P < 0.01), and in all satisfaction with chin items (profile, prominence, shape, and overall). Patients also demonstrated increased social confidence (+8.9, P = 0.29). There was no improvement in psychologic well-being (-0.8, P = 0.92). All 3 surgical groups of patients experienced gains in satisfaction with appearance following surgery. Patients who underwent orthognathic surgery either alone or in combination with genioplasty demonstrated statistically significant improvements in satisfaction with facial appearance overall (P < 0.01 for both groups), whereas patients who underwent genioplasty alone did not (P = 0.13). In addition, patients who underwent orthognathic surgery combined with genioplasty demonstrated greater improvement in satisfaction with chin than patients who underwent genioplasty alone. In conclusion, patients who underwent orthognathic surgery and/or genioplasty demonstrated improvement in appearance and social confidence. The use of this model supports the successful outcomes possible for patients undergoing these procedures.

Assessing Demographic Differences in Patient-Perceived Improvement in Facial Appearance and Quality of Life Following Rhinoplasty.

BACKGROUND: As rhinoplasty patient demographics evolve, surgeons must consider the impact of demographics on patient satisfaction. OBJECTIVES: The objective of this study was to identify independent demographic predictors of differences in satisfaction with appearance and quality of life following rhinoplasty utilizing the FACE-Q patient-reported outcome instrument. METHODS: Patients presenting for rhinoplasty completed the following FACE-Q scales: Satisfaction with Facial Appearance, Satisfaction with Nose, Social Function, and Psychological Well-being. Higher FACE-Q scores indicate greater satisfaction with appearance or superior quality of life. Pre- and post-treatment scores were compared in the context of patient demographics. RESULTS: The scales were completed by 59 patients. Women demonstrated statistically significant improvements in Satisfaction with Facial Appearance and quality of life while men only experienced significant improvement in Satisfaction with Facial appearance. Caucasians demonstrated statistically significant improvement in Satisfaction with Facial Appearance and quality of life while non-Caucasians did not. Patients younger than 35 years old were more likely to experience enhanced Satisfaction with Facial Appearance and quality of life compared with patients older than 35 years old. Patients with income ≥$100,000 were more likely to experience significant increases in Satisfaction with Facial Appearance and quality of life than patients with incomes <$100,000. CONCLUSIONS: In an objective study using a validated patient-reported outcome instrument, the authors were able to quantify differences in the clinically meaningful change in perception of appearance and quality of life that rhinoplasty patients gain based on demographic variables. The authors also demonstrated that these variables are potential predictors of differences in satisfaction.

Assessing Patient-Reported Satisfaction with Appearance and Quality of Life following Rhinoplasty Using the FACE-Q Appraisal Scales.

BACKGROUND: Patient satisfaction with appearance and improved quality of life are primary outcomes in cosmetic surgery. The purpose of this study was to assess changes in patient satisfaction with facial and nose appearance, and quality of life following rhinoplasty. METHODS: Patients presenting for rhinoplasty completed the FACE-Q, a new patient-reported outcome instrument composed of scales that measure outcomes in patients undergoing facial cosmetic procedures. The following FACE-Q scales were used: satisfaction with facial appearance overall, satisfaction with nose, psychological well-being, and social function. RESULTS: Fifty-six patients completed the FACE-Q at the time of their preoperative consultation and/or at postoperative follow-up visits. Among all patients presenting for rhinoplasty, FACE-Q scores (range, 0 to 100) increased following the procedure in satisfaction with facial appearance (+26.5; p < 0.01), psychological well-being (+15.7; p < 0.01), and social function (+13.7; p = 0.03). Satisfaction with nose item scores (range, 1 to 4) all increased significantly from before to after rhinoplasty, including in satisfaction with nose appearance in the mirror (+1.4; p < 0.01), size (+1.1; p < 0.01), shape (+1.5; p < 0.01), profile (+1.6; p < 0.01), and in photographs (+1.6; p < 0.01). Similar results were seen among a subgroup of patients who completed the FACE-Q scales both before and after rhinoplasty. CONCLUSIONS: In an objective study using a validated patient-reported outcome instrument, improvements in satisfaction with facial and nose appearance and quality of life were demonstrated among rhinoplasty patients. This model supports the successful outcomes possible in rhinoplasty. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

FACE-Q scales for health-related quality of life, early life impact, satisfaction with outcomes, and decision to have treatment: development and validation.

BACKGROUND: An ever-growing range of facial cosmetic products and treatments are available, but little clinical research is being performed to determine treatment outcomes from the patient's perspective. The FACE-Q is a patient-reported outcome instrument composed of more than 40 independently functioning scales and checklists. The aim of this article is to describe the development and psychometric evaluation of five new FACE-Q scales. METHODS: FACE-Q scales were developed according to international guidelines for patient-reported outcome instrument development. The following FACE-Q scales and a single symptom checklist (Recovery Early Symptoms) were evaluated in this study: Psychological Wellbeing, Social Function, Satisfaction with Decision to Have Treatment, Satisfaction with Outcome of Treatment, and Early Life Impact of Treatment. Modern and traditional psychometric methods were used to examine reliability, validity, and responsiveness. RESULTS: The sample included 702 participants from three studies. The FACE-Q scales were found to be reliable, valid, and responsive to clinical change. These findings were supported by Rasch measurement theory (e.g., overall chi-square values, p ≥ 0.06; Person Separation Index ≥0.81), traditional psychometric (e.g., Cronbach alpha values ≥0.90) and responsiveness (i.e., significant improvement following face lift and lip treatment) analysis. CONCLUSIONS: The FACE-Q measures concepts and symptoms important to facial aesthetic patients. The five scales and single symptom checklist described here can be used to measure what patients think about cosmetic treatments in a scientifically sound manner. As the cosmetics industry continues to expand, the patient perspective of treatment outcomes should be measured and reported. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, III.

Assessing outcomes in body contouring.

Patient-reported outcome (PRO) instruments are questionnaires designed to measure outcomes of importance to patients from their perspective. This article describes the methods used to develop a new PRO instrument for obese patients and patients having bariatric and cosmetic body contouring surgery. The BODY-Q is composed of 19 newly designed scales that measure: (1) appearance; (2) health-related quality of life; and (3) process of care. Recommended guidelines for PRO instrument development were followed to ensure that the BODY-Q meets requirements of regulatory bodies. The BODY-Q is currently being field-tested in an international study.

Measuring outcomes that matter to face-lift patients: development and validation of FACE-Q appearance appraisal scales and adverse effects checklist for the lower face and neck.

BACKGROUND: The FACE-Q is a new patient-reported outcome instrument to evaluate a range of outcomes for patients undergoing any type of facial cosmetic operation, minimally invasive cosmetic procedure, or facial injectable. This article describes the development and validation of FACE-Q scales relevant to face-lift patients. METHODS: The FACE-Q was developed by following international guidelines for patient-reported outcome instrument development. For outcomes following a face lift, the authors developed five appearance appraisal scales (i.e., Satisfaction with Cheeks, Satisfaction with Lower Face and Jawline, Appraisal of Nasolabial Folds, Appraisal of Area Under the Chin, and Appraisal of the Neck) and an adverse effects checklist. A field test of these scales was performed in a sample of 225 face-lift patients, and were evaluated using both modern and traditional psychometric methods. RESULTS: The five FACE-Q appearance appraisal scales were found to be clinically meaningful, reliable, valid, and responsive to clinical change. These findings were supported by Rasch measurement theory analysis (e.g., overall chi-square values of p ≥ 0.18; Person Separation Index ≥ 0.88). Responsiveness analyses showed that patient scores for facial appearance improved significantly after treatment (p < 0.001); changes in scores were associated with moderate effect sizes (range effect size, 0.40 to 0.79; range standardized response mean, 0.37 to 0.69). Traditional psychometric statistics provided further support (e.g., Cronbach's alpha values ≥ 0.94) CONCLUSIONS:: The FACE-Q appearance appraisal scales are scientifically sound and clinically meaningful and can be used with the adverse effects checklist to measure patient-reported outcomes following a face lift.

Chest and upper body morbidity following immediate postmastectomy breast reconstruction.

OBJECTIVE: The performance of a mastectomy for the treatment or prophylaxis of breast cancer may have long-term implications for both physical and mental well-being in women. The development of breast numbness and phantom breast sensations following mastectomy is well-known; however, relatively little is known about physical morbidity following postmastectomy breast reconstruction. The primary objective of this study was to evaluate the level of physical morbidity experienced following three surgical approaches: mastectomy alone, postmastectomy tissue expander/implant reconstruction, and postmastectomy autogenous tissue reconstruction. METHODS: We conducted a cross-sectional survey of a sample of women who had undergone mastectomy with or without reconstruction. Chest and upper body morbidity were evaluated using the BREAST-Q. Physical well-being was compared across three types of breast surgery. RESULTS: In total, 308 of 452 women who received a questionnaire booklet returned completed questionnaires. There was an overall difference in physical morbidity attributable to surgical treatment (P < 0.001). Patients who underwent autogenous tissue reconstruction had the highest (i.e., best) mean physical well-being score. Women who underwent expander/implant reconstruction also had less chronic physical morbidity than women who underwent mastectomy alone (P < 0.05). CONCLUSIONS: Our findings suggest that women who undergo immediate autogenous tissue reconstruction experience significantly less chest and upper body morbidity than those who undergo either mastectomy with implant-based reconstruction or mastectomy alone. This information can be used to facilitate clinical decision-making, to validate individual experiences of breast cancer survivors, and to inform future innovations to decrease the long-term physical morbidity associated with breast cancer surgery.

Development and psychometric evaluation of the FACE-Q Aging Appraisal Scale and Patient-Perceived Age Visual Analog Scale.

BACKGROUND: The primary outcome measures for patients who undergo aesthetic facial procedures are quality of life and satisfaction with appearance. The FACE-Q, a new patient-reported outcome (PRO) instrument composed of independently functioning scales, is designed to measure a broad range of important outcomes in patients who undergo cosmetic surgical and/or nonsurgical facial procedures. OBJECTIVES: The authors describe the development and psychometric evaluation of the FACE-Q Aging Appraisal Scale and the FACE-Q Patient-Perceived Age Visual Analog Scale (VAS). METHODS: International guidelines for creating PRO instruments were strictly observed throughout development of the FACE-Q scales. Qualitative methods were used to identify the concepts most important to patients who received aesthetic facial procedures. These were turned into "items"-and the resultant FACE-Q Aging Appraisal Scale was field tested, along with the Patient-Perceived Age VAS, in 288 patients who underwent cosmetic surgical and/or nonsurgical facial procedures. RESULTS: Rasch measurement theory and traditional psychometric methods confirmed the reliability and validity of the scales. CONCLUSIONS: The FACE-Q Aging Appraisal Scale and Patient-Perceived Age VAS are psychometrically sound, condition-specific PRO instruments with excellent reliability and validity. They enable accurate outcome assessments in patients who undergo aesthetic facial procedures.

Optimizing patient-centered care in breast reconstruction: the importance of preoperative information and patient-physician communication.

BACKGROUND: In breast reconstruction, achieving patient satisfaction is a central goal. While much is known about clinical variables that may influence satisfaction, little is known about how the process of care may affect patient perceptions of outcome. The aim of this study was to examine how preoperative information and interactions with the surgical and medical teams might influence patient satisfaction with the outcome. METHODS: A multicenter, cross-sectional study design was used. The BREAST-Q (breast reconstruction module) was administered in a postal survey to a cohort of breast reconstruction patients in North America. The association between patient satisfaction with the process of care and satisfaction with the outcome of breast reconstruction was evaluated using linear regression. Multivariate regression models were constructed to control for confounders and to identify predictors of outcome. RESULTS: The study sample (n=510; response rate, 66 percent) was characterized by a mean age of 54.3±9.3 years (range, 21.0 to 81.0 years) and a mean body mass index of 25.2±4.3 (range, 16.3 to 48.9). On multivariate analysis, satisfaction with information and satisfaction with the plastic surgeon predicted higher satisfaction with breasts (information, p<0.001; plastic surgeon, p=0.003; R(2)=0.29) and higher satisfaction with overall outcome (satisfaction with information, p<0.001; satisfaction with plastic surgeon, p<0.001; R(2)=0.31). CONCLUSIONS: Patient-centered care is an important aspect of quality of care. Patients' levels of satisfaction with preoperative information and their interaction with their plastic surgeon significantly influence satisfaction with their breasts and overall outcome. Future research to develop methods to enhance information delivery and the surgeon-patient relationship may optimize outcomes in breast reconstruction patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.