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.

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.

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.

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.

Long-term patient-reported satisfaction after contralateral prophylactic mastectomy and implant reconstruction.

PURPOSE: To determine whether satisfaction and health-related quality of life (HR-QoL) differ between women who do and do not undergo contralateral prophylactic mastectomy (CPM) in the setting of implant reconstruction using the BREAST-Q, a validated patient-reported outcome instrument. METHODS: From 2000 to 2007, a total of 3,874 patients with stage 0 to III unilateral breast cancer (BC) had mastectomy; 688 (18 %) pursued CPM within 1 year. Patients who completed the BREAST-Q reconstruction module as part of BREAST-Q validation studies or routine clinical care formed our study cohort. Comparisons were made between CPM and no-CPM patients using univariate analysis and multivariate models (MVA). RESULTS: Of 294 patients with BREAST-Q data, 112 (38 %) had CPM. Median time from mastectomy to BREAST-Q was 52 months. CPM patients were younger (mean 47 vs. 50 years), more likely to be White (98 vs. 86 %), married (84 vs. 71 %), have a family history of BC (60 vs. 44 %), and to choose silicone implants (67 vs. 48 %). There were no differences in tumor or treatment characteristics between groups at the time of BREAST-Q. Patients with CPM had a higher mean score for Satisfaction with Breasts (64.4 vs. 54.9; p < 0.001) and Satisfaction with Outcome (74.8 vs. 67.7; p = 0.007); other HR-QoL domains did not differ. On MVA, CPM and the absence of lymphedema were significant predictors of Satisfaction with Breasts (CPM p = 0.005, lymphedema p = 0.039). CPM was not associated with improved Satisfaction with Outcome. CONCLUSIONS: This study suggests that in the setting of implant reconstruction, CPM has a positive correlation with patient satisfaction with their breasts, but not with improvements in other HR-QoL domains.

Development and psychometric evaluation of the FACE-Q satisfaction with appearance scale: a new patient-reported outcome instrument for facial aesthetics patients.

Satisfaction with appearance and improved quality of life are key outcomes for patients undergoing facial aesthetic procedures. The FACE-Q is a new patient-reported outcome (PRO) instrument encompassing a suite of independently functioning scales designed to measure a range of important outcomes for facial aesthetics patients. FACE-Q scales were developed with strict adherence to international guidelines for PRO instrument development. This article describes the development and psychometric evaluation of the core FACE-Q scale, the Satisfaction with Facial Appearance scale. Both modern and traditional psychometric methods were used to confirm that this new 10-item scale is a reliable, valid, and responsive measure.

A closer look at the BREAST-Q(©).

The BREAST-Q(©) is a multiscale, multimodule, patient-reported outcome instrument (PRO) measuring health-related quality of life and patient satisfaction in women who undergo breast surgery. This PRO instrument is the flagship of our team's research, which has spanned almost a decade. This article provides detail about the BREAST-Q(©). The BREAST-Q(©) represents a significant advance in measuring the impact and effectiveness of breast surgery from the patients' perspective. In addition, our overall approach may provide a useful template for the development of future PRO instruments.

Measuring health-related quality of life outcomes in head and neck reconstruction.

A qualitative study was undertaken to understand the impact of omitted health concepts in existing patient-reported outcome (PRO) instruments for health-related quality of life (HR-QOL) evaluation following head and neck (H&N) cancer reconstruction. Twenty-six patients were interviewed. Patients described a broad range of symptoms. Oral competence, rhinorrhea, facial sensation, smile, vision and eye discharge are missing from existing PRO instruments. Altered appearance was a major stressor; both function and appearance changes had a negative psychosocial impact leading to social isolation and embarrassment. This framework is the foundation for development of a more complete PRO instrument, the FACE-Q Oncology.

Measuring quality of life and patient satisfaction in facial paralysis patients: a systematic review of patient-reported outcome measures.

BACKGROUND: Incomplete recovery from facial nerve damage has functional deficits and significant social and psychological consequences. To evaluate the success of surgical and nonsurgical interventions in facial paralysis patients, patient satisfaction and impact on quality of life should be considered. The objective of this study is to identify existing patient-reported outcome instruments that measure quality-of-life outcomes in the facial paralysis population. METHODS: A systematic review of the English-language literature was performed to identify patient-reported outcome instruments that have been developed and validated for use in facial paralysis patients. Each qualifying measure was evaluated for content and psychometric properties, as outlined by international recommended guidelines for item generation, item reduction, and psychometric evaluation. RESULTS: From 598 articles, 28 questionnaires assessing facial paralysis were identified. Only three questionnaires satisfied the inclusion and exclusion criteria: the Facial Clinimetric Evaluation Scale, the Facial Disability Index, and a questionnaire developed to study aberrant facial nerve regeneration. Although these patient-reported outcome instruments show evidence of development and validation, no measures satisfy all instrument development and validation guidelines. All instruments were limited in domains that address self-perception of facial appearance and procedure-related symptoms or satisfaction. CONCLUSIONS: Although instruments are available for measuring outcomes with respect to facial function, there are few instruments developed to specifically evaluate the impact of facial paralysis on quality of life. To quantify treatment outcomes of facial paralysis patients, future research to develop and validate a new patient-reported outcome instrument is needed.

The BREAST-Q: further validation in independent clinical samples.

BACKGROUND: The BREAST-Q is a new patient-reported outcome instrument for cosmetic and reconstructive breast surgery. For it to be used appropriately in clinical research, it is important that its validity is demonstrated. The aim of this study was to test this property. METHODS: The authors evaluated the BREAST-Q subscales by using Rasch measurement methods and traditional psychometric methods with a focus on construct validity (including comparisons with existing breast-related, patient-reported outcome measures) and clinical validity (including hypothesis-driven questions with clinical subsamples). RESULTS: A total of 817 women returned completed questionnaires (corrected response rate, 66 percent). Validity was supported by three Rasch analysis findings: the number of item response options was found to be appropriate (thresholds were ordered correctly); item locations in each subscale were spread out (range of logit span, 0.7 to 6.6), indicating that each subscale captures a wide range of issues; and fit to the Rasch model was good. Overall, scale reliability was supported by high Person separation indices (≥0.73). Traditional psychometric scale validity was supported by interscale correlations, comparisons of scores generated from clinically defined subgroups, and correlations with sociodemographic variables. Scale reliability was supported by high Cronbach's alpha coefficients (>0.80), item-total correlations (range of means, 0.58 to 0.87), and intraclass correlation coefficients (>0.80). CONCLUSIONS: This study further supports the BREAST-Q as a useful tool to study the impact and effectiveness of breast surgery from the patients' perspective. It can be used as the initial building blocks toward establishing the clinical meaning of BREAST-Q scale scores, further supporting an evidence-based approach to surgical practice.

Patient-reported outcome measures in plastic surgery: use and interpretation in evidence-based medicine.

Understanding patients' perceptions of surgical results and their impacts on quality of life is of primary importance in plastic surgery, as procedures are largely performed to improve either appearance or function. Patient-reported outcome measures are questionnaires specifically designed to quantify aspects of health-related quality of life from the patient's perspective. This article presents an overview of patient-reported outcome measures. It also aims to provide plastic surgeons with the necessary critical appraisal skills to interpret and apply evidence from patient-reported outcomes research in their own clinical practice.

The efficacy of Artecoll injections for the augmentation of nipple projection in breast reconstruction.

INTRODUCTION: Various techniques have been used in an attempt to achieve long-term nipple projection following nipple-areolar reconstruction. A common setback, however, is the diminution of projection overtime; this phenomenon is particularly evident following implant-based breast reconstruction. Artecoll may be suitable for injection into the nipple complex to maintain permanent, 3-dimensional projection. Artecoll is an injectable substance that is biocompatible and immunologically inert and resists degradation in vivo. The purpose of this study was thus to prospectively evaluate the efficacy of Artecoll (polymethylmethacrylate microspheres suspended in 3.5% denatured bovine collagen with 0.3% lidocaine) in obtaining and maintaining nipple projection following postmastectomy, nipple-areolar reconstruction. METHODS: A prospective, clinical trial was performed. Consecutive patients deemed to have inadequate nipple projection at least 6 months following "C-V flap" or "modified-skate flap" reconstruction were identified. Only women who had postmastectomy reconstruction with tissue expanders and implants were considered eligible for participation. Artecoll was injected under the nipple at 2 time points: baseline and 3 months. Calipers were used to measure nipple projection preinjection and postinjection at baseline, 3, 6, and 9 months. RESULTS: Thirty-three nipples were injected in 23 patients. There were no adverse events. Prior to injection, mean nipple projection was 1.33 +/- 1.0 mm. The mean increase in projection over the 9-month study period was both clinically and statistically significant (1.60 +/- 1.24 mm; P <.001). A history of prior irradiation was a significant negative predictor of final nipple projection (P = .012). CONCLUSION: Artecoll injection is both feasible and effective in increasing and maintaining nipple projection in the setting of implant-based breast reconstruction.