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

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

Machine learning with PROs in breast cancer surgery; caution: Collecting PROs at baseline is crucial

As high breast cancer survival rates are achieved nowadays, irrespective of type of surgery performed, prediction of long-term physical, sexual, and psychosocial outcomes is very important in treatment decision-making. Patient-reported outcomes (PROs) can help facilitate this shared decision-making. Given the significance of more personalized medicine and the growing trend on the application of machine learning techniques, we are striving to develop an algorithm using machine learning techniques to predict PROs in breast cancer patients treated with breast surgery. This short communication describes the bottlenecks in our attempt to predict PROs

Quality of life and symptom assessment in randomized clinical trials of bladder cancer: A systematic review

OBJECTIVES: Patient-reported outcomes (PRO) help patients, caretakers, clinicians, and policy makers make informed decisions regarding treatment effectiveness. Our objective was to assess the quality of PRO reporting and methodological strengths and weaknesses in randomized controlled trials (RCT) in bladder cancer.; METHODS: A systematic literature search of bladder cancer RCT published between January 2004 and March 2014 was performed. Relevant studies were evaluated using a predetermined extraction form that included trial demographics, clinical and PRO characteristics, and standards of PRO reporting based on recommendations of the International Society for Quality of Life Research.; RESULTS: In total, 9 RCTs enrolling 1,237 patients were evaluated. All studies were in patients with nonmetastatic disease. In 5 RCTs, a PRO was the primary end point. Most RCTs did not report the mode of administration of the PRO instrument or the methods of collecting data. No RCT addressed the statistical approaches for missing data.; CONCLUSIONS: We found that few RCTs in bladder cancer report PRO as an outcome. Efforts to expand PRO reporting to more RCTs and improve the quality of PRO reporting according to recognized standards are necessary for facilitating clinical decision making. Copyright 2015 Elsevier Inc. All rights reserved

Patient-Reported Morbidity Instruments: A Systematic Review

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

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

Translation and psychometric assessment of the mastectomy module of the BREAST-Q questionnaire for use in Nigeria

Background: The majority of non-metastatic breast cancer patients in sub-Saharan Africa are recommended to have mastectomy. The impact of mastectomy on a predominantly young African patient population requires evaluation. The BREAST-Q is a validated patient-reported outcome measure of quality-of-life following breast surgery that has been translated into 30 languages-none in Africa. This study aimed to translate and assess the psychometric properties of the mastectomy module of the BREAST-Q for use in Nigeria. Methods: The BREAST-Q mastectomy module was translated from English to Yoruba and its psychometric properties assessed using best practice guidelines. Translation was performed in 4 steps: forward translation (x2), back translation, back translation review, and cognitive interviews with post-mastectomy patients. The translated BREAST-Q instrument was administered to post-mastectomy patients (n = 21) alongside the EORTC-QLQ BR23 to evaluate construct validity. Test-retest reliability was evaluated using intraclass correlation coefficients (ICC); surveys were re-administered 4 weeks apart. Results: The translation process identified English phrases not amenable to direct translation, including “emotionally healthy” and descriptions of pain (“nagging,” “throbbing,” “sharp”). Translations were amended to reflect local context and question intent. During cognitive interviews, patients provided suggestions to simplify complex phrases, e.g. “discomfort in your breast area.”. Internal consistency within scales was over 0.70 for psychosocial wellbeing (α = 0.84–0.87), sexual wellbeing (α = 0.98–0.99), physical wellbeing in chest (α = 0.84–0.86), and satisfaction with care (α = 0.89–0.93). ICC for test-retest reliability was moderate (0.46–0.63). Conclusions: The Yoruba version of the BREAST-Q mastectomy module presents a unique opportunity to adequately capture the experiences of Nigerian women post mastectomy. This instrument is being used in a pilot study of Nigerian patients to identify targets for intervention to improve the patient experience and compliance with breast cancer surgery