Patient-Reported Outcomes in Free-Flap Breast Reconstructive Surgery over Time (PRO-BREST)

INTRODUCTION Patient-reported outcomes (PROMs) are increasingly relevant to assess surgical quality and guide decisions in breast reconstruction (BR). Satisfaction with outcomes may change as time progresses. We assessed satisfaction in patients who underwent free-flap BR in the last 12 years. METHODS All patients who underwent free-flap BR from 2006 to 2018 were invited to complete the validated BREAST-Q for reconstruction. The BREAST-Q comprises 6 domains covering various aspects of satisfaction. Unadjusted linear regression assessed the relationship between different domains of the BREAST-Q and time since BR. Two-sample t tests assessed differences in satisfaction between patients who underwent BR ≥5 years versus <5 years prior. RESULTS Forty-three women with primary or secondary free-flap BR between 2006 and 2018 were included in the study. Most patients (n = 33, 76.7%) underwent DIEP flap BR. Overall satisfaction with breasts and with outcomes improved as time since BR increased (p = 0.031 and p = 0.017, respectively). Overall satisfaction with outcomes scored higher in patients with BR ≥5 years prior (≥5 years vs. <5 years: breast score 88.6 (SD 12.5) versus 66.9 (SD 21.8); p = 0.005). Satisfaction with breasts and psychosocial well-being also scored higher in these patients. There was no difference in results between primary and secondary BR. Patients who underwent additional surgery (refinements) reported higher satisfaction with outcomes and abdominal well-being. CONCLUSIONS PROMs concerning satisfaction with breast and with outcomes following BR improve as time since treatment progresses. This study demonstrates that time since diagnosis may be an important factor in satisfaction. It underlines the importance of long-term PROMs related to BR, to help provide patients and health care professionals in decision-making and in managing expectations related to BR

Managing suicidal ideation in a breast cancer cohort seeking reconstructive surgery

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/135255/1/pon4017_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/135255/2/pon4017.pd

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

Dutch translation and cultural adaptation of new LYMPH-Q- scales measuring impact on work and lymphedema worry

Background: Breast cancer-related lymphedema (BCRL) is a significant complication of breast cancer treatment that can impact patients’ quality of life. This study focuses on the translation and cultural adaptation of two new LYMPH-Q scales ‘Impact on Work’ and ‘Lymphedema worry’ into Dutch to assess the work-related challenges and worries experienced by patients with BCRL in the Netherlands. Methods: The translation process followed established guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the World Health Organization (WHO). Forward and back translations, expert panel reviews, cognitive debriefing interviews with patients with BCRL, and proofreading were conducted to refine the Dutch translation of the scales. The translation aimed to ensure conceptual equivalence and cultural relevance. Results: The translation process resulted in the Dutch versions of the LYMPH-Q ‘Impact on Work’ and ‘Lymphedema worry’ scales. The forward translation revealed discrepancies in meaning, word order and synonyms. The back translation and review resulted in changes in item formulation. The expert panel meeting and cognitive debriefing interviews provided valuable input for further refinement. Conclusion: The translated LYMPH-Q ‘Impact on Work’ and ‘Lymphedema worry’ scales provide healthcare professionals with an instrument to assess and monitor the impact of BCRL on work-related challenges and on worries. This comprehensive translation process, involving patients with BCRL and experts, ensured the linguistic accuracy, cultural relevance, and clarity of the Dutch versions. The translated scales will contribute to a better understanding of the multifaceted impact of BCRL and facilitate the development of tailored interventions to improve patients’ well-being and functional outcomes.</p

Up regulation in gene expression of chromatin remodelling factors in cervical intraepithelial neoplasia

<p>Abstract</p> <p>Background</p> <p>The highest rates of cervical cancer are found in developing countries. Frontline monitoring has reduced these rates in developed countries and present day screening programs primarily identify precancerous lesions termed cervical intraepithelial neoplasias (CIN). CIN lesions described as mild dysplasia (CIN I) are likely to spontaneously regress while CIN III lesions (severe dysplasia) are likely to progress if untreated. Thoughtful consideration of gene expression changes paralleling the progressive pre invasive neoplastic development will yield insight into the key casual events involved in cervical cancer development.</p> <p>Results</p> <p>In this study, we have identified gene expression changes across 16 cervical cases (CIN I, CIN II, CIN III and normal cervical epithelium) using the unbiased long serial analysis of gene expression (L-SAGE) method. The 16 L-SAGE libraries were sequenced to the level of 2,481,387 tags, creating the largest SAGE data collection for cervical tissue worldwide. We have identified 222 genes differentially expressed between normal cervical tissue and CIN III. Many of these genes influence biological functions characteristic of cancer, such as cell death, cell growth/proliferation and cellular movement. Evaluation of these genes through network interactions identified multiple candidates that influence regulation of cellular transcription through chromatin remodelling (<it>SMARCC1</it>, <it>NCOR1</it>, <it>MRFAP1 </it>and <it>MORF4L2</it>). Further, these expression events are focused at the critical junction in disease development of moderate dysplasia (CIN II) indicating a role for chromatin remodelling as part of cervical cancer development.</p> <p>Conclusion</p> <p>We have created a valuable publically available resource for the study of gene expression in precancerous cervical lesions. Our results indicate deregulation of the chromatin remodelling complex components and its influencing factors occur in the development of CIN lesions. The increase in SWI/SNF stabilizing molecule <it>SMARCC1 </it>and other novel genes has not been previously illustrated as events in the early stages of dysplasia development and thus not only provides novel candidate markers for screening but a biological function for targeting treatment.</p

Iterative qualitative approach to establishing content validation of a patient-reported outcome measure for arm lymphedema:the LYMPH-Q Upper Extremity Module

Background: Breast cancer-related lymphedema (BRCL) is one of the most common causes of upper extremity (UE) lymphedema in developed nations and substantially impacts health-related quality of life. To advance our understanding of the epidemiology and treatment of BRCL, rigorously developed and validated patient-reported outcome measures (PROMs) are needed. This study aimed to demonstrate the iterative content validity of a modular UE lymphedema-specific PROM called the LYMPH-Q UE module. Methods:A multi-step iterative qualitative approach was used. Semi-structured interview data from in-depth qualitative interviews with adult women (18 years and older) with BCRL were used to develop the first set of the LYMPH-Q UE scales. The content validity of these scales was demonstrated with patient and clinician feedback. Over the course of cognitive debriefing interviews, additional concepts of lymphedema worry and impact on work were identified as missing from the LYMPH-Q UE module. Subsequently, two new qualitative studies (a focus group and in-depth concept elicitation interviews with patients) were conducted, and two new scales were developed to measure lymphedema worry and impact on work life and their content validity was dResults: emonstrated. Qualitative data from in-depth and cognitive interviews with 15 (age 40–74 years) and 16 (age 38–74 years) women with BRCL, respectively, and feedback from 12 clinical experts, were used to develop and demonstrate the content validity of six LYMPH-Q UE scales measuring symptoms, function, appearance, psychological, information, and arm sleeve. Additionally, data from in-depth interviews with 12 (age 35–72 years) women with UE lymphedema and four focus groups (n = 16 women; age 35–74 years) was used to develop and assess the content validity of two new LYMPH-Q UE scales measuring lymphedema worry and impact on work life. The content validity of the previously established six scales was also demonstrated in these subsequent qualitative studies. Conclusion: The LYMPH-Q UE is a modular PROM developed using international guidelines for PROM development and can be used in clinical practice, research, and quality improvement to enhance patient-centered shared decision-making. This study’s innovative and iterative approach to content validation demonstrates that the LYMPH-Q UE is a comprehensive measure that includes important concepts relevant to patients with UE lymphedema.</p

The Use of Acellular Dermal Matrices in Two-Stage Expander/Implant Reconstruction: A Multicenter, Blinded, Randomized Controlled Trial

Current efficacy data supporting the routine use of acellular dermal matrices (ADM) in postmastectomy tissue expander/implant reconstruction is limited. A multi-center, blinded, randomized controlled study was designed to evaluate the effectiveness of ADM in the setting of TE/I reconstruction. The primary objective of the study was to determine whether the use of ADM would decrease patient-reported, post-operative pain. The secondary objective was to determine whether the use of ADM accelerated the rate of post-operative expansion. Tertiary objectives included an evaluation of long-term aesthetic results, capsular contracture rates and patient satisfaction

Measuring the patient perspective on latissimus dorsi donor site outcomes following breast reconstruction.

BACKGROUND: There is little evidence about the long-term donor site outcome of latissimus dorsi breast reconstruction and no patient-reported outcome measures designed specifically for the procedure. METHODS: A prospective cohort of breast cancer patients having latissimus dorsi reconstruction after a mastectomy was recruited from 270 hospitals in the United Kingdom. An 18-month follow up questionnaire containing two novel scales was sent to consenting patients. The prevalence of aesthetic and functional morbidity at the donor site was described. The two new scales were refined using the Rasch measurement model and subsequently validated. RESULTS: 1,096 women completed the new scales. 78% of patients reported that no back appearance issues had bothered them "most of the time" or "all of the time" in the past two weeks. The equivalent figure for functional morbidity was 60%. Four items were eliminated following initial psychometric testing. This produced an 8-item Back Appearance scale and an 11-item Back and Shoulder Function scale. Both scales showed adequate fit to the Rasch measurement model. Higher levels of aesthetic and functional bother were observed for completely autologous procedures versus those where latissimus dorsi reconstruction was used to cover an implant (p <0.05). Higher levels of aesthetic bother were observed in women who had suffered a perioperative complication at the donor site (p = 0.003). CONCLUSION: These results can inform patients of the morbidity associated with latissimus dorsi reconstruction. The new scales can be used to compare groups undergoing different variations of the procedure and to monitor individual patients

The HAND-Q : Psychometrics of a New Patient-reported Outcome Measure for Clinical and Research Applications

Background: The perspective of the patient in measuring the outcome of their hand treatment is of key importance. We developed a hand-specific patient-reported outcome measure to provide a means to measure outcomes and experiences of care from the patient perspective, that is, HAND-Q. Methods: Data were collected from people with a broad range of hand conditions in hand clinics in six countries between April 2018 and January 2021. Rasch measurement theory analysis was used to perform item reduction and to examine reliability and validity of each HAND-Q scale. Results: A sample of 1277 patients was recruited. Participants ranged in age from 16 to 89 years, 54% were women, and a broad range of congenital and acquired hand conditions were represented. Rasch measurement theory analysis led to the refinement of 14 independently functioning scales that measure hand appearance, health-related quality of life, experience of care, and treatment outcome. Each scale evidenced reliability and validity. Examination of differential item functioning by age, gender, language, and type of hand condition (ie, nontraumatic versus traumatic) confirmed that a common scoring algorithm for each scale could be implemented. Conclusions: The HAND-Q was developed following robust psychometric methods to provide a comprehensive modular independently functioning set of scales. HAND-Q scales can be used to assess and compare evidence-based outcomes in patients with any type of hand condition.Peer reviewe