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Objective To synthesize the current state of PROM implementation and collection in routine surgical practice through a review of the literature. Summary of background data Patient-reported outcomes (PROs) are increasingly relevant in the delivery of high quality, individualized patient care. For surgeons, patient reported outcome measures (PROMs) can provide valuable insight into changes in patient quality of life before and after surgical interventions. Despite consensus within the surgical community regarding the promise of PROMs, little is known about their real-world implementation. Methods The literature search was conducted in MEDLINE and Embase for studies published after 2012. We conducted a scoping review to synthesize the current state of implementation of PROs across all sizes and types of surgical practices. Studies were included if they met the following inclusion criteria: (1) patients ≥18 years 2) routine surgical practice, (3) use of a validated PRO instrument in the peri-operative period to report on general or disease-specific health-related quality of life, (4) primary or secondary outcome was implementation. Two independent reviewers screened 1524 titles and abstracts. Findings 16 studies were identified that reported on the implementation of PROMs for surgical patients. Sample size ranged from 41 patients in a single-center pilot study to 1324 patients in a study across 17 institutions. PROs were collected pre-operatively in three studies, post-operatively in 10, and at unspecified times in four. The most commonly reported implementation outcomes were fidelity (12) and feasibility (11). Less than half of studies analyzed non-respondents. All studies concluded that collection of PROMs was successful based on outcomes measured. Conclusions The identified studies suggest that implementation metrics including minimum standards of collection pre- and post-intervention, reporting for response rates in the context of patient eligibility and analysis of respondents and non-respondents, in addition to transparency regarding the resources utilized and cost, can facilitate adoption of PROMs in clinical care and accountability for surgical outcomes.

OBJECTIVE We implemented routine daily electronic monitoring of patient-reported outcomes (PROs) for 10 days after discharge after ambulatory cancer surgery, with alerts to clinical staff for worrying symptoms. We sought to determine whether enhancing this monitoring by adding immediate automated normative feedback to patients regarding expected symptoms would further improve the patient experience. SUMMARY OF BACKGROUND DATA PRO monitoring reduces symptom severity in cancer patients. In ambulatory cancer surgery, it reduces potentially avoidable urgent care center (UCC) visits, defined as those UCC visits without readmission. METHODS Patients undergoing ambulatory cancer surgery (n = 2624) were randomized to receive standard PRO monitoring or enhanced feedback. The primary study outcome was UCC visits without readmission within 30 days; secondary outcomes included patient anxiety and nursing utilization. RESULTS There was no significant difference in the risk of a potentially avoidable UCC visit [1.0% higher in enhanced feedback, 95% confidence interval (CI) -0.2-3.1%; P = 0.12]. There were similarly no significant differences in UCC visits with readmission or readmission overall (P = 0.4 for both). Patients randomized to enhanced feedback demonstrated a quicker reduction in anxiety (P < 0.001) and required 14% (95% CI 8-19%; P < 0.001) and 10% (95% CI 5-16%, P < 0.001) fewer nursing calls over 10 and 30 days postoperatively. CONCLUSIONS Providing patients with feedback about symptom severity during recovery from ambulatory cancer surgery reduces anxiety and nursing workload without affecting UCC visits or readmissions. These results support wider incorporation of normative feedback in systems for routine PRO monitoring.

The purpose of this study was to determine the prevalence of psychiatric diagnoses among a sample of breast reconstruction patients and measure the association between these diagnoses and reconstruction-related, patient-reported outcomes.The impact of psychiatric disorders in conjunction with breast cancer diagnosis, treatment, and reconstruction have the potential to cause significant patient distress but remains not well understood.A retrospective review of postmastectomy breast reconstruction patients from 2007 to 2018 at Memorial Sloan Kettering Cancer Center was conducted. Patient demographics, comorbidities, cancer characteristics, psychiatric diagnoses, and BREAST-Q Reconstruction Module scores (measuring satisfaction with breast, well-being of the chest, psychosocial, and sexual well-being) at postoperative years 1 to 3 were examined. Mixed-effects models and cross-sectional linear regressions were conducted to measure the effect of psychiatric diagnostic class type and number on scores.Of 7414 total patients, 50.1% had at least 1 psychiatric diagnosis. Patients with any psychiatric diagnoses before reconstruction had significantly lower BREAST-Q scores for all domains at all time points. Anxiety (50%) and depression (27.6%) disorders were the most prevalent and had the greatest impact on BREAST-Q scores. Patients with a greater number of psychiatric diagnostic classes had significantly worse patient-reported outcomes compared with patients with no psychiatric diagnosis. Psychosocial (β: -7.29; 95% confidence interval: -8.67, -5.91), and sexual well-being (β: -7.99; 95% confidence interval: -9.57, -6.40) were most sensitive to the impact of psychiatric diagnoses.Mental health status is associated with psychosocial and sexual well-being after breast reconstruction surgery as measured with the BREAST-Q. Future research will need to determine what interventions (eg, screening, early referral) can help improve outcomes for breast cancer patients with psychiatric disorders undergoing breast reconstruction.

This study explored surgical oncologists' perspectives on factors influencing adoption of quality standards in patients with advanced cancer.The American College of Surgeons Geriatric Surgery Verification Program includes communication standards designed to facilitate goal-concordant care, yet little is known about how surgeons believe these standards align with clinical practice.Semi-structured video-based interviews were conducted from November 2020-January 2021 with academic surgical oncologists purposively sampled based on demographics, region, palliative care certification and years in practice. Interviews addressed: (1) adherence to standards documenting care preferences for life-sustaining treatment, surrogate decision-maker, and goals of surgery, and (2) factors influencing their adoption into practice. Interviews were audio-recorded, transcribed, qualitatively analyzed, and conducted until thematic saturation was reached.Twenty-six surgeons participated (57.7% male, 8.5 mean years in practice, 19.2% palliative care board-certified). Surgeons reported low adherence to documenting care preferences and surrogate decision-maker and high adherence to discussing, but not documenting, goals of surgery. Participants held conflicting views about the relevance of care preferences to preoperative conversations and surrogate decision-maker documentation by the surgeon and questioned the direct connection between documentation of quality standards and higher value patient care. Key themes regarding factors influencing adoption of quality standards included organizational culture, workflow, and multidisciplinary collaboration.Although surgeons routinely discuss goals of surgery, documentation is inconsistent; care preferences and surrogate decision-makers are rarely discussed or documented. Adherence to these standards would be facilitated by multidisciplinary collaboration, institutional standardization, and evidence linking standards to higher value care.

To synthesize the current state of PROM implementation and collection in routine surgical practice through a review of the literature.Patient-reported outcomes (PROs) are increasingly relevant in the delivery of high quality, individualized patient care. For surgeons, PROMs can provide valuable insight into changes in patient quality of life before and after surgical interventions. Despite consensus within the surgical community regarding the promise of PROMs, little is known about their real-world implementation.The literature search was conducted in MEDLINE and Embase for studies published after 2012. We conducted a scoping review to synthesize the current state of implementation of PROs across all sizes and types of surgical practices. Studies were included if they met the following inclusion criteria: (1) patients ≥18 years 2) routine surgical practice, (3) use of a validated PRO instrument in the peri-operative period to report on general or disease-specific health-related quality of life, (4) primary or secondary outcome was implementation. Two independent reviewers screened 1524 titles and abstracts.16 studies were identified that reported on the implementation of PROMs for surgical patients. Sample size ranged from 41 patients in a single-center pilot study to 1324 patients in a study across 17 institutions. PROs were collected pre-operatively in 3 studies, post-operatively in 10, and at unspecified times in 4. The most commonly reported implementation outcomes were fidelity (12) and feasibility (11). Less than half of studies analyzed nonrespondents. All studies concluded that collection of PROMs was successful based on outcomes measured.The identified studies suggest that implementation metrics including minimum standards of collection pre- and postintervention, reporting for response rates in the context of patient eligibility and analysis of respondents and nonrespondents, in addition to transparency regarding the resources utilized and cost, can facilitate adoption of PROMs in clinical care and accountability for surgical outcomes.

To better understand the long-term patient-reported outcomes (PROs) in satisfaction and health-related quality of life (QOL) following post-mastectomy reconstruction (PMR) using the BREAST-Q, comparing PROs from patients undergoing implant-based breast reconstruction (IBR) or autologous breast reconstruction (ABR).Multiple studies have demonstrated growth in mastectomy rates and concurrent increase in PMR utilization. However, most studies examining PMR PROs focus on short postoperative time periods-mainly within 2 years.BREAST-Q scores from IBR or ABR patients at a tertiary center were prospectively collected from 2009 to 2017. Mean scores and standard deviations (SDs) were calculated for satisfaction with breast, satisfaction with outcome, psychosocial well-being, physical well-being of the chest, and sexual well-being. Satisfaction with breasts and physical well-being of the chest were compared using regression models at postoperative years 1, 3, 5, and 7.Overall, 3268 patients were included, with 336 undergoing ABR and 2932 undergoing IBR. Regression analysis demonstrated that ABR patients had greater postoperative satisfaction with breast scores at all timepoints compared with IBR patients. Postoperative radiation and mental illness adversely impacted satisfaction with breast scores. Furthermore, mental illness impacted physical wellbeing of the chest at all timepoints. IBR patients had satisfaction scores that remained stable over the study period.This study presents the largest prospective examination of PROs in PMR to date. Patients who opted for ABR had significantly higher satisfaction with their breast and QOL at each assessed time point, but IBR patients had stable long-term satisfaction and QOL postoperatively.

Objective The primary aim of this study was to compare patient-reported outcomes (PROs) of women who underwent immediate implant-based breast reconstruction (IBBR) after receiving either: (1) nipple-sparing mastectomy (NSM) or (2) simple mastectomy with subsequent nipple reconstruction (SNR). Background The goal of post-mastectomy breast reconstruction is to restore body image and quality-of-life after mastectomy, but removal of the nipple-areolar complex may have its own negative psychosocial consequences. NSM may have increased in popularity due to its perceived oncologic safety in many women and to reports of superior aesthetic results with this technique. Despite the increased utilization of NSM, few studies have evaluated the impact of NSM on PROs and complications in women undergoing immediate IBBR. Methods We performed a secondary analysis of the Mastectomy Reconstruction Outcomes Consortium study, a multicenter, prospective cohort study that recruited patients between February 2012 and July 2015. The primary aim of this study was to compare PROs as measured by BREAST-Q scores between women who underwent IBBR after NSM versus SNR. The secondary aim was to compare complication rates. Mixed-effects regression models controlled for demographic and clinical covariates. Results Of the 600 women in the study, 286 (47.7%) underwent NSM. After controlling for baseline patient characteristics, we found no significant differences in satisfaction with breast, psychosocial well-being, physical well-being or sexual well-being between women undergoing NSM versus SNR. Mastectomy type was not a significant predictor of complications or reconstructive failure. Conclusions Despite reports of superior aesthetics for NSM over simple mastectomy with nipple reconstruction in immediate IBBR, we found no significant differences at 2 years after reconstruction in patient satisfaction, quality-of-life, or complication rates.

Objective Our objectives were to investigate case-mix adjusted hospital variations in 2-year clinical and patient-reported outcomes following immediate breast reconstruction. Background Over the past few decades, variations in medical practice have been viewed as opportunities to promote best practices and high-value care. Methods The Mastectomy Reconstruction Outcomes Consortium Study is an National Cancer Institute-funded longitudinal, prospective cohort study assessing clinical and patient-reported outcomes of immediate breast reconstruction after mastectomy at 11 leading medical centers. Case-mix adjusted comparisons were performed using generalized linear mixed-effects models to assess variation across the centers in any complication, major complications, satisfaction with outcome, and satisfaction with breast. Results Among 2252 women in the analytic cohort, 1605 (71.3%) underwent implant-based and 647 (28.7%) underwent autologous breast reconstruction. There were significant differences in the sociodemographic and clinical characteristics, and distribution of procedure types at the different Mastectomy Reconstruction Outcomes Consortium Study centers. After case-mix adjustments, hospital variations in the rates of any and major postoperative complications were observed. Medical center odds ratios for major complication ranged from 0.58 to 2.13, compared with the average major complication rate across centers. There were also meaningful differences in satisfaction with outcome (from the lowest to highest of -2.79-2.62) and in satisfaction with breast (-2.82-2.07) compared with the average values. Conclusions Two-year postoperative complications varied widely between hospitals following post-mastectomy breast reconstruction. These variations represent an important opportunity to improve care through dissemination of best practices and highlight the limitations of extrapolating single-institution level data and the ongoing challenges of studying hospital-based outcomes for this patient population.

Objective We developed, tested, and validated machine learning algorithms to predict individual patient-reported outcomes at 1-year follow-up to facilitate individualized, patient-centered decision-making for women with breast cancer. Summary background data Satisfaction with breasts is a key outcome for women undergoing cancer-related mastectomy and reconstruction. Current decision-making relies on group-level evidence which may lead to sub-optimal treatment recommendations for individuals. Methods We trained, tested, and validated three machine learning algorithms using data from 1921 women undergoing cancer-related mastectomy and reconstruction conducted at eleven study sites in North America from 2011 to 2016. Data from 1921 women undergoing cancer-related mastectomy and reconstruction were collected prior to surgery and at 1-year follow-up. Data from 10 of the 11 sites was randomly split into training and test samples (2:1 ratio) to develop and test three algorithms (logistic regression with elastic net penalty, Extreme Gradient Boosting tree, and neural network) which were further validated using the additional site's data.Accuracy and area-under-the-receiver-operating-characteristics-curve (AUC) to predict clinically-significant changes in satisfaction with breasts at 1-year follow-up using the validated BREAST-Q were the outcome measures. Results The three algorithms performed equally well when predicting both improved or decreased satisfaction with breasts in both testing and validation datasets: For the testing dataset median accuracy= 0.81 (range 0.73-0.83), median AUC= 0.84 (range 0.78-0.85). For the validation dataset median accuracy= 0.83 (range 0.81-0.84), median AUC= 0.86 (range 0.83-0.89). Conclusion Individual patient-reported outcomes can be accurately predicted using machine learning algorithms, which may facilitate individualized, patient-centered decision-making for women undergoing breast cancer treatment.

Objective This study sought to estimate the incidence and incidence rate of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) at a high-volume single institution, which enables vigorous long-term follow-up and implant tracking for more accurate estimates. Summary background data The reported incidence of BIA-ALCL is highly variable, ranging from 1 in 355 to 1 in 30,000 patients, demonstrating a need for more accurate estimates. Methods All patients who underwent implant-based breast reconstruction from 1991 to 2017 were retrospectively identified. The incidence and incidence rate of BIA-ALCL were estimated per patient and per implant. A time-to-event analysis was performed using the Kaplan-Meier estimator and life table. Results During the 26-year study period, 9373 patients underwent reconstruction with 16,065 implants, of which 9589 (59.7%) were textured. Eleven patients were diagnosed with BIA-ALCL, all of whom had a history of textured implants. The overall incidence of BIA-ALCL was 1.79 per 1000 patients (1 in 559) with textured implants and 1.15 per 1000 textured implants (1 in 871), with a median time to diagnosis of 10.3 years (range, 6.4-15.5 yrs). Time-to-event analysis demonstrated a BIA-ALCL cumulative incidence of 0 at up to 6 years, increasing to 4.4 per 1000 patients at 10 to 12 years and 9.4 per 1000 patients at 14 to 16 years, although a sensitivity analysis showed loss to follow-up may have skewed these estimates. Conclusions BIA-ALCL incidence and incidence rates may be higher than previous epidemiological estimates, with incidence increasing over time, particularly in patients exposed to textured implants for longer than 10 years.

In postmastectomy reconstruction, procedure choice is heavily influenced by the relative risks of the various options. This study sought to evaluate complications in a large, multicenter patient population.Previous studies have reported widely varying complication rates, but have been limited by their single center designs and inadequate controlling for confounders in their analyses.Eleven sites enrolled women undergoing first time, immediate, or delayed reconstruction following mastectomy for cancer treatment or prophylaxis. Procedures included expander/implant, latissimus dorsi (LD), pedicle transverse rectus abdominis musculocutaneous (PTRAM), free TRAM (FTRAM), and deep inferior epigastric perforator (DIEP) techniques. Data were gathered pre- and postoperatively from medical records. Separate logistic regressions were conducted for all complications and major complications (those requiring rehospitalization and/or reoperation) within 1 year. Odds ratios (ORs) were calculated for procedure type, controlling for site, demographic, and clinical variables.Complication rates for 2234 patients were analyzed. Compared with expander/implant reconstructions, LD (OR) 1.95, P = 0.026), PTRAM (OR 1.89, P = 0.025), FTRAM (OR 1.94, P = 0.011), and DIEP (OR 2.22, P0.001) procedures were associated with higher risks of complications. Significantly higher risks were also associated with older age, higher body mass index (BMI), immediate reconstruction, bilateral procedures, and radiation. For major complications, regression showed significantly greater risks for PTRAM (OR 1.86, P = 0.044) and DIEP (OR 1.75, P = 0.004), than expander/implant reconstructions. Failure rates were relatively low, ranging from 0% for PTRAM to 5.9% for expander/implant reconstructions.In this multicenter analysis, procedure choice and other patient variables were significant predictors of 1-year complications in breast reconstruction. These findings should be considered in counseling patients on reconstructive options.

Assess postoperative morbidity and patient-reported outcomes after unilateral and bilateral breast reconstruction in patients with unilateral breast cancer.Relatively little is known about the morbidity associated with and changes in quality of life experienced by patients who undergo contralateral prophylactic mastectomy (CPM) and breast reconstruction. This information would be valuable for decision making in patients with unilateral breast cancer.Women undergoing mastectomy and breast reconstruction for unilateral breast cancer were recruited for this prospective observational study. Postoperative complications after implant and autologous breast reconstruction in patients undergoing unilateral or bilateral mastectomy were recorded. Preoperative and 1 year patient-reported outcomes were measured. Univariate tests and logistic regression analyses were performed, studying the effects of reconstructive method, laterality, and risk factors on surgical complication rates, patient satisfaction, and anxiety.We identified 1144 women who underwent either unilateral (47.2%) or bilateral (52.8%) mastectomies with reconstruction. Bilateral autologous (odds ratio 1.73, 95% confidence interval 1.07-2.81) and implant reconstructions (odds ratio 1.73, 95% confidence interval 1.22-2.47) were associated with a higher risk of complications compared with unilateral reconstructions. Baseline anxiety was greater in women who chose bilateral compared with unilateral implant reconstructions (P = 0.001). There was no difference in anxiety levels between groups postoperatively. Postoperatively, women who chose CPM with implant reconstructions were more satisfied with their breasts than women with unilateral reconstructions (P = 0.034).Although higher postoperative complications were observed after CPM and reconstruction, these procedures were associated with decreased anxiety levels and improved satisfaction with breasts for women who underwent implant reconstructions.

OBJECTIVE The aim of the study was to determine the association of patient-reported experiences (PREs) and risk-adjusted surgical outcomes among group practices. BACKGROUND The Centers for Medicare and Medicaid Services required large group practices to submit PREs data for successful participation in the Physician Quality Reporting System (PQRS) using the Consumer Assessment of Healthcare Providers and Systems for PQRS survey. Whether these PREs data correlate with perioperative outcomes remains ill defined. METHODS Operations between January 1, 2014 and December 31, 2016 in the American College of Surgeons' National Surgical Quality Improvement Program registry were merged with 2015 Consumer Assessment of Healthcare Providers and Systems for PQRS survey data. Hierarchical logistic models were constructed to estimate associations between 7 subscales and 1 composite score of PREs and 30-day morbidity, unplanned readmission, and unplanned reoperation, separately, while adjusting for patient- and procedure mix. RESULTS Among 328 group practices identified, patients reported their experiences with clinician communication the highest (mean ± standard deviation, 82.66 ± 3.10), and with attention to medication cost the lowest (25.96 ± 5.14). The mean composite score was 61.08 (±6.66). On multivariable analyses, better PREs scores regarding medication cost, between-visit communication, and the composite score of experience were each associated with 4% decreased odds of morbidity [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.92-0.99], readmission (OR 0.96, 95% CI 0.93-0.99), and reoperation (OR 0.96, 95% CI 0.93-0.99), respectively. In sensitivity analyses, better between-visit communication remained significantly associated with fewer readmissions. CONCLUSIONS In these data, patients' report of better between-visit communication was associated with fewer readmissions. More sensitive, surgery-specific PRE assessments may reveal additional unique insights for improving the quality of surgical care.

Background Advances in breast cancer diagnosis and management have produced significant improvements in disease-free and breast cancer related survival. Consequently, there is increasing focus on the quality of long-term cancer survivorship. Of the 44,000 women diagnosed annually in the United Kingdom, 30% to 40% are required to undergo mastectomy. During the past 30 years, significant technical advances in breast reconstruction have increased performance of this surgical practice as a means to potentially improve health-related quality of life (HRQoL) for breast cancer survivors. Breast reconstruction studies increasingly aim to assess more discriminating outcomes based on the patients' own perception of the surgical result and its effect on HRQoL. This incremental output in HRQoL evaluation is being fuelled by both healthcare providers and official bodies such as the Food and Drug Administration, together with demands for more comprehensive comparative effectiveness data to permit fully informed consent by patients. Methods In this systematic review, the authors apply inclusion and exclusion criteria to effectively screen 1012 abstracts identified in the field of HRQoL in breast reconstruction between 1978 and 2009. Each study was evaluated with respect to its design and statistical methodology. Each was reviewed with a recommended standard checklist of methodological requirements as described by Efficace et al (J Clin Oncol. 2003;21:3502-3511). Results A total of 34 papers that included HRQL outcomes in breast reconstruction were identified and reviewed in detail. The majority of studies were retrospective in nature with significant inherent limitations. Specifically, they were compromised by potentially biased patient recall. Most of these studies lacked both an a priori outcome of interest and statistical rigor jeopardizing estimations of potential effect size. In addition, more than 90% of the studies failed to report or describe missing data. Thirteen studies provided level I (n = 2) and II (n = 11) evidence. While these studies benefited from more robust design, the majority used generic instruments such as 36-item short form (SF-36), which may not be sufficiently sensitive to measure changes consequent to breast reconstruction (ie, effect on body image or psychosocial well-being). Furthermore, these studies were generally underpowered to detect meaningful clinical difference or to permit subgroup analyses. Further limitations included reliance on single center design that may negatively impact generalizability and deficiencies in reporting the number and types of surgical complications, which potentially has an effect on HRQoL outcomes. Conclusions This systematic review reveals tendency for sound scientific methodology in HRQoL to be undermined by poorly designed and underpowered studies. In the current healthcare environment, patients and providers increasingly seek meaningful data to guide clinical decisions; policy makers are similarly in need of a rigorous patient-centered, comparative effectiveness data to inform national level decision-making. In light of this and the limitations of the existing published data, there is a pressing need for further Level I and II evidence in the form of randomized controlled trials as well as well-designed, multicenter prospective longitudinal studies in breast reconstruction. Such studies should incorporate sensitive and condition-specific patient-report outcome measures, provide adequate sample sizes, and respect established guidelines for rigorous HRQoL methodology.