Satisfaction and quality of life in women who undergo breast surgery: a qualitative study to develop conceptual model

Background: In cosmetic and reconstructive breast surgery, measurement of patient-reported outcomes has become increasingly important to research efforts and clinical care. We aimed to describe how breast conditions and breast surgery impact on patient satisfaction and quality of life. Methods: We conducted qualitative, in-depth interviews with 48 women who had undergone either breast reduction (n = 15), breast augmentation (n = 12), or breast reconstruction (n = 21) surgery in order to begin to build a theoretical understanding of patient satisfaction and quality of life in breast surgery patients. Interviews were audio-taped, transcribed verbatim and analyzed thematically. Results: The patient interviews revealed that breast conditions and breast surgery impact women in the following six main areas: satisfaction with breasts; satisfaction with overall outcome; psychosocial well-being; sexual well-being; physical well-being; and satisfaction with the process of care. We used these six themes to form the basis of a conceptual framework of patient satisfaction and quality of life in women who undergo breast surgery. Conclusion: Our conceptual framework establishes the main issues of concern for breast surgery patients. This new framework can be used to help develop local guidelines for future clinical assessment, management and measurement, establish the validity of the current management strategies, and develop evidence-based guidance for the development of new patient reported outcome measures for future outcomes research

Patient-reported treatment response in chronic graft-versus-host disease

Chronic graft-versus-host disease (GvHD) treatment response is assessed using National Institutes of Health (NIH) Consensus Criteria in clinical trials, and by clinician assessment in routine practice. Patient-reported treatment response is central to the experience of chronic GvHD manifestations as well as treatment benefit and toxicity, but how they correlate with clinician- or NIH-responses has not been well-studied. We aimed to characterize 6-month patientreported response, determine associated chronic GvHD baseline organ features and changes, and evaluate which patientreported quality of life and chronic GvHD symptom burden measures correlated with patient-reported response. From two nationally representative Chronic GVHD Consortium prospective observational studies, 382 subjects were included in this analysis. Patient and clinician responses were categorized as improved (completely gone, very much better, moderately better, a little better) versus not improved (about the same, a little worse, moderately worse, very much worse). At six months, 270 (71%) patients perceived chronic GvHD improvement, while 112 (29%) perceived no improvement. Patient-reported response had limited correlation with either clinician-reported (kappa 0.37) or NIH chronic GvHD response criteria (kappa 0.18). Notably, patient-reported response at six months was significantly associated with subsequent failure-free survival. In multivariate analysis, NIH responses in eye, mouth, and lung had significant association with 6-month patient-reported response, as well as a change in Short Form 36 general health and role physical domains and Lee Symptom Score skin and eye changes. Based on these findings, patient-reported responses should be considered as an important complementary endpoint in chronic GvHD clinical trials and drug development

Axatilimab for chronic graft-versus-host disease after failure of at least two prior systemic therapies: Results of a phase I/II study

PURPOSE: Chronic graft-versus-host disease (cGVHD) remains the major cause of late morbidity after allogeneic hematopoietic cell transplantation. Colony-stimulating factor 1 receptor (CSF-1R)-dependent macrophages promote cGVHD fibrosis, and their elimination in preclinical studies ameliorated cGVHD. Axatilimab is a humanized monoclonal antibody that inhibits CSF-1R signaling and restrains macrophage development. PATIENTS AND METHODS: This phase I (phI)/phase II (phII) open-label study (ClinicalTrials.gov identifier: NCT03604692) evaluated safety, tolerability, and efficacy of axatilimab in patients age ≥ 6 years with active cGVHD after ≥ 2 prior systemic therapy lines. Primary objectives in phI were to identify the optimal biologic and recommended phII dose and in phII to evaluate the overall (complete and partial) response rate (ORR) at the start of treatment cycle 7. RESULTS: Forty enrolled patients (17 phI; 23 phII) received at least one axatilimab dose. In phI, a dose of 3 mg/kg given once every 4 weeks met the optimal biologic dose definition. Two dose-limiting toxicities occurred at the 3 mg/kg dose given once every 2 weeks. At least one treatment-related adverse event (TRAE) was observed in 30 patients with grade ≥ 3 TRAEs in eight patients, the majority known on-target effects of CSF-1R inhibition. No cytomegalovirus reactivations occurred. With the 50% ORR at cycle 7 day 1, the phII cohort met the primary efficacy end point. Furthermore, the ORR in the first six cycles, an end point supporting regulatory approvals, was 82%. Responses were seen in all affected organs regardless of prior therapy. Fifty-eight percent of patients reported significant improvement in cGVHD-related symptoms using the Lee Symptom Scale. On-target activity of axatilimab was suggested by the decrease in skin CSF-1R-expressing macrophages. CONCLUSION: Targeting profibrotic macrophages with axatilimab is a therapeutically promising novel strategy with a favorable safety profile for refractory cGVHD

Standardizing definitions of hematopoietic recovery, graft rejection, graft failure, poor graft function, and donor chimerism in allogeneic hematopoietic cell transplantation: A report on behalf of the American Society for Transplantation and Cellular Therapy

Allogeneic hematopoietic cell transplantation (allo-HCT) is potentially curative for certain hematologic malignancies and nonmalignant diseases. The field of allo-HCT has witnessed significant advances, including broadening indications for transplantation, availability of alternative donor sources, less toxic preparative regimens, new cell manipulation techniques, and novel GVHD prevention methods, all of which have expanded the applicability of the procedure. These advances have led to clinical practice conundrums when applying traditional definitions of hematopoietic recovery, graft rejection, graft failure, poor graft function, and donor chimerism, because these may vary based on donor type, cell source, cell dose, primary disease, graft-versus-host disease (GVHD) prophylaxis, and conditioning intensity, among other variables. To address these contemporary challenges, we surveyed a panel of allo-HCT experts in an attempt to standardize these definitions. We analyzed survey responses from adult and pediatric transplantation physicians separately. Consensus was achieved for definitions of neutrophil and platelet recovery, graft rejection, graft failure, poor graft function, and donor chimerism, but not for delayed engraftment. Here we highlight the complexities associated with the management of mixed donor chimerism in malignant and nonmalignant hematologic diseases, which remains an area for future research. We recognize that there are multiple other specific, and at times complex, clinical scenarios for which clinical management must be individualized

Patient-Reported Morbidity Instruments: A Systematic Review

This is the author accepted manuscript. The final version is available from Elsevier via the DOI in this record.Objectives: Although comorbidities play an essential role in risk adjustment and outcomes measurement, there is little consensus regarding the best source of this data. The aim of this study was to identify general patient-reported morbidity instruments and their measurement properties. Methods: A systematic review was conducted using multiple electronic databases (Embase, Medline, Cochrane Central, and Web of Science) from inception to March 2018. Articles focusing primarily on the development or subsequent validation of a patient-reported morbidity instrument were included. After including relevant articles, the measurement properties of each morbidity instrument were extracted by 2 investigators for narrative synthesis. Results: A total of 1005 articles were screened, of which 34 eligible articles were ultimately included. The most widely assessed instruments were the Self-Reported Charlson Comorbidity Index (n = 7), the Self-Administered Comorbidity Questionnaire (n = 3), and the Disease Burden Morbidity Assessment (n = 3). The most commonly included conditions were diabetes, hypertension, and myocardial infarction. Studies demonstrated substantial variability in item-level reliability versus the gold standard medical record review (κ range 0.66-0.86), meaning that the accuracy of the self-reported comorbidity data is dependent on the selected morbidity. Conclusions: The Self-Reported Charlson Comorbidity Index and the Self-Administered Comorbidity Questionnaire were the most frequently cited instruments. Significant variability was observed in reliability per comorbid condition of patient-reported morbidity questionnaires. Further research is needed to determine whether patient-reported morbidity data should be used to bolster medical records data or serve as a stand-alone entity when risk adjusting observational outcomes data.Federation of Dutch University Medical Centers (NFU)Gliklich Healthcare Innovation Scholar Fund/Massachusetts Eye and Ear InfirmaryAmerican Board of Medical Specialtie

Preoperative estimation of cosmetic outcomes after immediate breast reconstruction with extended latissimus dorsi flap: A simple prediction model

Background: The extended latissimus dorsi (ELD) flap can provide adequate volume for breast reconstruction without an implant. The aim of this study was to identify a simple method to estimate preoperatively if the ELD flap would provide enough volume for breast reconstruction and good cosmetic outcome. The proposed model was based on correlating the preoperative body mass index (BMI) and breast cup size. Methods: This retrospective cohort study included 64 patients who underwent immediate breast reconstruction with ELD at the National Cancer Institute, Cairo University, between January 2014 and January 2016. Preoperative breast cup size and patients' BMI were recorded. The primary end point was cosmetic outcome score assessed by three independent breast surgeons and the patients. Correlation analysis was performed between the preoperative factors and final cosmetic outcome. Results: Sixty-four patients underwent immediate reconstruction following skin-sparing mastectomy. BMI range was 23–38 kg/m2 with a median of 28. All patients with cup size A had aesthetically pleasing results. As the breast cup size increased, the favorable cosmetic outcomes were noted with lower BMI. All patients with BMI higher than 33 had unfavorable results. Conclusion: Favorable cosmetic outcomes are expected after ELD reconstruction in patients with cup size A regardless of the BMI. As the breast cup size increases, favorable cosmetic outcomes are expected in patients with lower BMI than in those with higher BMI. At a BMI of 34, no favorable cosmetic outcomes are expected. The prediction model will be validated in a prospective study

“It’s a silver lining”: A template analysis of satisfaction and quality of life following post-mastectomy breast reconstruction

The file attached to this record is the author's final peer reviewed version.Objective: In the United Kingdom, the number of women electing to undergo post-mastectomy breast reconstruction is increasing. As a consequence exploring patient-reported outcomes in breast surgery has become increasingly important. This study aims to explore satisfaction and quality of life following post-mastectomy breast reconstruction. Design: Qualitative research design. Methods: In-depth, semi-structured telephone interviews were conducted with 25 women, (Age, M= 53.08, SD=8.41) following breast reconstruction in the United Kingdom. Data were analysed using template analysis which produced three first-level, 13 second-level and 19 third-level themes. Results: Following reconstruction women reported improved emotional functioning, although this was often accompanied with deterioration in physical, sexual and/or social functioning. Women positively appraised their breast appearance, although some reported a decline in satisfaction over time and attributed this decline to their chosen reconstructive technique. Many women accepted the inevitability of scarring and most perceived their scars as a representation of their journey, signifying survival. Generally women were satisfied with the outcome of their reconstruction, although on reflection some would not have opted for reconstruction. Following breast reconstruction women were increasingly likely to experience the fear of recurrence, attributed to no longer being able to have a mammogram on the affected breast(s). Conclusions: This study provides new insights into post-mastectomy breast reconstruction and is a novel application of the qualitative data analysis method, template analysis. Template analysis demonstrates only slight variation in some categories of experience among women, despite a heterogeneous sample. The findings allow researchers and clinicians to focus on specific dimensions of satisfaction and quality of life to positively support the needs of women following reconstructio

Ageing and recurrent episodes of neuroinflammation promote progressive experimental autoimmune encephalomyelitis in Biozzi ABH mice

We gratefully acknowledge the Progressive Multiple Sclerosis Alliance for financial support