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

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

Optimizing Axillary Management in Clinical T1-2N0 Mastectomy Patients with Positive Sentinel Lymph Nodes.

BACKGROUND: Following publication of the AMAROS trial, we sought to optimize axillary lymph node dissection (ALND) or postmastectomy radiation therapy (PMRT) + axillary radiation (AxRT) utilization in cT1-2N0 patients with 1-2 positive sentinel lymph nodes (SLNs) after mastectomy. METHODS: In November 2015, our multidisciplinary group implemented a protocol to omit intraoperative SLN evaluation for mastectomy patients with cT1-2N0 breast cancer likely to be recommended PMRT if found to have 1-2 positive SLNs (age ≤ 60 years and/or high-risk features defined as estrogen receptor-negative and/or positive for lymphovascular invasion). We prospectively evaluated axillary management, short-term complications, and oncologic outcomes in patients with 1-2 positive SLNs. RESULTS: From November 2015 to December 2018, 479 of 560 (85%) cT1-2N0 breast cancers treated with mastectomy were potential candidates for PMRT. Intraoperative SLN evaluation was omitted in 344 (72%), thus following the protocol. Overall, 121 cases had 1-2 positive SLNs: 17 (14%) were managed with observation, 5 (4%) PMRT alone, 59 (49%) PMRT + AxRT, 16 (13%) ALND alone, and 24 (20%) ALND + PMRT. Protocol compliance resulted in less ALND (8% vs. 24%) and less ALND + PMRT (9% vs. 41%, p < 0.01). At median follow-up of 24 months, there was one regional and four distant recurrences, with no regional recurrences or differences in disease-free survival in patients treated with ALND versus PMRT + AxRT (100% vs. 98%, p = 0.67). Similarly, there were no differences in complication rates (p = 0.18). CONCLUSIONS: Omitting intraoperative SLN evaluation in cT1-2N0 mastectomy patients who would be candidates for PMRT if found to have positive nodes decreased rates of ALND and minimized use of ALND + PMRT without compromising outcomes.

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

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

The Effect of the Breast Cancer Provider Discussion Law on Breast Reconstruction Rates in New York State.

BACKGROUND: New York State passed the Breast Cancer Provider Discussion Law in 2010, mandating discussion of insurance coverage for reconstruction and expedient plastic surgical referral, two significant factors found to affect reconstruction rates. This study examines the impact of this law. METHODS: A retrospective cohort study of the New York State Planning and Research Cooperative System database to examine breast reconstruction rates 3 years before and 3 years after law enactment was performed. Difference-interrupted time series models were used to compare trends in the reconstruction rates by sociodemographic factors and provider types. RESULTS: The study included 32,452 patients. The number of mastectomies decreased from 6479 in 2008 to 5235 in 2013; the rate of reconstruction increased from 49 percent in 2008 to 62 percent in 2013. This rise was seen across all median income brackets, races, and age groups. When comparing before to after law enactment, the increase in risk-adjusted reconstruction rates was significantly higher for African Americans and elderly patients, but the disparity in reconstruction rates did not change for other races, different income levels, or insurance types. Reconstruction rates were also not significantly different between those treated in various hospital settings. CONCLUSIONS: The aim of the Breast Cancer Provider Discussion Law is to improve reconstruction rates through provider-driven patient education. The authors' data show significant change following law passage in African American and elderly populations, suggesting effectiveness of the law. The New York State Provider Discussion Law may provide a template for other states to model legislation geared toward patient-centered improvement of health outcomes.

In Search of an Ideal Closure Method: A Randomized, Controlled Trial of Octyl-2-Cyanoacrylate and Adhesive Mesh versus Subcuticular Suture in Reduction Mammaplasty.

BACKGROUND: An ideal wound closure system is one that is effective, consistent, and efficient. Recent studies have demonstrated the efficacy of octyl-2-cyanoacrylate and mesh (Dermabond Prineo) in the closure of surgical wounds. This study compared the use of Prineo to use of subcuticular suture closure in reduction mammaplasty. METHODS: A prospective, randomized, controlled, single-blind study of patients undergoing bilateral reduction mammaplasty was performed. Each breast per patient was randomized to layered closure with Prineo or subcuticular sutures. Incisions were assessed at 2 weeks, 6 weeks, 6 months, and 1 year. Subjects completed the Patient and Observer Scar Assessment Scale for each breast, and two blinded plastic surgeons evaluated scar quality using the Vancouver Scar Scale at each time point. RESULTS: Twenty-one patients participated in the study. On average, Prineo closure took 58.38 seconds (2.50 seconds/cm) and subcuticular closure took 444.76 seconds (18.94 seconds/cm). Prineo closure was approximately 6.8 times faster (p < 0.001) than subcuticular closure, saving an average of 6.4 minutes per incision. Vancouver Scar Scale scores were significantly better in patients with Prineo closure at 2 weeks (p = 0.026), although there was no difference in Patient and Observer Scar Assessment Scale and Vancouver Scar Scale scores at all other time points. CONCLUSIONS: In reduction mammaplasty, Prineo closure results in similar scar quality and lower operative cost without increased complications when compared to subcuticular closure. Prineo is faster than subcuticular closure and represents an effective, consistent, and efficient alternative to subcuticular suture techniques. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Is Article Methodological Quality Associated With Conflicts of Interest?: An Analysis of the Plastic Surgery Literature.

PURPOSE: Conflicts of interest (COI) are an emerging area of discussion within the field of plastic surgery. Recently, several reports have found that research studies that disclose COI are associated with publication of positive outcomes. We hypothesize that this association is driven by higher-quality studies receiving industry funding. This study aimed to investigate the association between industry support and study methodological quality. METHODS: We reviewed all entries in Plastic and Reconstructive Surgery, Annals of Plastic Surgery, and Journal of Plastic, Reconstructive, and Aesthetic Surgery within a 1-year period encompassing 2013. All clinical research articles were analyzed. Studies were evaluated blindly for methodology quality based on a validated scoring system. An ordinal logistic regression model was used to examine the association between methodology score and COI. RESULTS: A total of 1474 articles were reviewed, of which 483 met our inclusion criteria. These articles underwent methodological quality scoring. Conflicts of interest were reported in 28 (5.8%) of these articles. After adjusting for article characteristics in the ordinal logistic regression analysis, there was no significant association between articles with COI and higher methodological scores (P = 0.7636). CONCLUSIONS: Plastic surgery studies that disclose COI are not associated with higher methodological quality when compared with studies that do not disclose COI. These findings suggest that although the presence of COI is associated with positive findings, the association is not shown to be driven by higher-quality studies.

Financial Conflicts of Interest: An Association between Funding and Findings in Plastic Surgery.

BACKGROUND: Despite a growing interest in examining the effects of industry funding on research in plastic surgery, no study to date has comprehensively examined the effects of financial conflicts of interest on publication outcomes. The authors investigated the association between financial conflicts of interest and reported study findings in plastic surgery research. METHODS: The authors reviewed all entries in Plastic and Reconstructive Surgery, Annals of Plastic Surgery, and Journal of Plastic, Reconstructive & Aesthetic Surgery from January 1, 2012, to December 31, 2012. All clinical and basic science articles were analyzed. The following article characteristics were extracted: self-reported financial conflicts of interest, sample size, level of evidence, study design, and prospectiveness. The findings reported in each abstract were blindly graded as not applicable, negative, or positive. RESULTS: Of the 1650 abstracts that resulted from the authors' initial search, 568 fulfilled the inclusion criteria. The majority of the included articles covered breast (20.8 percent), experimental (19.7 percent), and general reconstruction (31.69 percent). Financial conflicts of interest were disclosed in only 17.6 percent of the articles. Of the total studies that met inclusion criteria, 66.2 percent were reviewed as having positive outcomes, and 33.8 percent were reviewed as having negative or not applicable results. Studies that disclosed a financial conflict of interest were 7.12 times more likely (p < 0.0001) to present a positive outcome over a negative outcome compared with studies with no financial conflict of interest. CONCLUSION: Investigators with a financial conflict of interest are significantly more likely to publish plastic surgery studies with a positive conclusion compared with investigators with no conflicts of interest.