Comparison of Patient-reported Outcomes after Implant Versus Autologous Tissue Breast Reconstruction Using the BREAST-Q

Background: The demand for reconstructive breast procedures of various types has accelerated in recent years. Coupled with increased patient expectations, it has fostered the development of oncoplastic and reconstructive techniques in breast surgery. In the setting of postmastectomy reconstruction, patient satisfaction and quality of life are the most significant outcome variables when evaluating surgical success. The aim of this study was to evaluate the quality of life after implant breast reconstruction compared with autologous breast reconstruction. Materials and Methods: A cross-sectional study design was used. A total of 65 women who had completed postmastectomy implant-based or autologous reconstruction in the participating center were asked to complete the BREAST-Q (Reconstruction Module). Results: Data analysis demonstrated that women with autologous breast reconstruction were significantly more satisfied with their breasts (P = 0.0003) and with the overall outcome (P = 0.0001) compared with women with implant breast reconstruction. All other BREAST-Q parameters that were considered and observed were not significantly different between the 2 patient groups. Conclusions: Through statistical analysis, our results showed that patients who underwent autologous tissue reconstruction had better satisfaction with the reconstructed breast and the outcome, while both techniques appear to equally improve psychosocial well-being, sexual well-being, and chest satisfaction

Health-related quality of life in people with severe aphasia

Background: Health-related quality of life (HRQL) measures are increasingly used to help us understand the impact of disease or disability on a person's life and to measure the effectiveness of interventions. A small number of studies have looked at perceived HRQL in people with mild or moderate aphasia. They report that reduced HRQL is associated with low psychological well-being and depression, reduced activity levels and high levels of communication disability. Still, very little is known about the quality of life of people with severe aphasia. Aims: This study aimed to evaluate the HRQL of people with severe aphasia as rated by their proxy respondents. To increase our understanding of these proxy evaluations, the findings were compared with those of two other studies of HRQL in people with moderate or mild aphasia, using proxy and self-report respondents. Methods & Procedures: A questionnaire-based cross-sectional survey was carried out where proxies of people with severe aphasia reported on their HRQL. The people with severe aphasia who took part in this study were part of a larger cohort of people with aphasia who were able to self-report on their HRQL. Aphasia was assessed with the American Speech and Hearing Association Functional Assessment of Communication Skills for Adults (ASHA-FACS) and the Frenchay Aphasia Screening Test (FAST) and HRQL with the Stroke and Aphasia Quality of Life (SAQOL) scale (proxy-reported). SAQOL-39 scores were derived from the SAQOL. Results & Results: People with severe aphasia's quality of life, as measured by their proxies (n = 12), was low and more than one standard deviation below that of the standardization sample of the SAQOL. The overall mean score for the SAQOL-39 and the means for its physical and communication domains were below the 20th centile. They were also significantly lower that those of the comparison studies of self-reports (n = 83) and proxy ratings (n = 50) of people with mild or moderate aphasia (p0.003). In the comparison studies there were no significant differences between the self-report and proxy ratings of people with mild or moderate aphasia. Conclusions & Implications: This small study suggests that the HRQL of people with severe aphasia, as reported by their proxies, is severely compromised. Further research, using a wide range of methodologies, is needed in order to address the challenge of understanding better the quality of life of people with severe aphasia

Social network interventions in mental healthcare: a protocol for an umbrella review

Introduction: Social networks (SNs) can play a crucial role in the process of recovery from mental illness. Yet there is no standard best practice for involving SNs to optimise patient recovery. It is therefore critical to explore the diversity of SN approaches in mental health, highlight gaps in the evidence and suggest future directions for research and practice. This protocol describes the methods for an umbrella review of SN interventions for the care and/or treatment of mental illness. // Methods and analysis: Nine electronic databases will be searched for the relevant journal articles: CINAHL, PubMed, Scopus, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Library, Web of Science, Scopus and Ovid PsycINFO. We will include reviews which extracted information about the quantity, structure and quality of patient’s SNs as well as frequency of contact. The range of publication dates of the included articles will be from 2010 and 2021, as recommended by Joanna Briggs Institute guidelines. The Assessment of Multiple Systematic Reviews 2 tool and ratings of the quality of evidence will be used to assess the quality of the included reviews. The results will be presented in accordance with guidelines in the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 statement. Findings will inform the development of an SN framework to guide the design and evaluation of psychosocial interventions. // Ethics and dissemination: This umbrella review will involve secondary data analysis and ethical approval is not required. The target audience includes clinicians, researchers and service users, who will be reached with tailored materials through journal publications, conference presentations and social media. The presentation of the results will provide a more complete picture of relevant evidence and explicit basis from which to improve psychosocial well-being for people diagnosed with a mental illness

การทดสอบเบื้องต้นแบบประเมินผลลัพธ์ด้านการรักษาด้วยการใช้ยาที่ได้จากการรายงานของผู้ป่วยสำหรับคุณภาพชีวิตด้านยาโดยใช้วิธีเชิงผสมผสาน Preliminary Test of the Patient-Reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life (PROMPT-QoL) Using

Objective: To preliminarily test PROMPT-QoL (Patient-Reported OutcomesMeasure of Pharmaceutical Therapy for Quality of Life) using mixedmethods based on qualitative (cognitive interviews) and quantitative (aRasch model) approaches. Method: The test of PROMPT-QoL wasconducted with 60 outpatients at King Chulalongkorn Memorial hospitalwho had been using medications for at least 3 months. Cognitive interviewswere used to explore comprehension problems of items, response choices,instructions/formats and other problems. A Rasch model was used toquantitatively identify problems of items and scale layout. Results:According to cognitive interviews, indecision about the cause of impacts ofmedicines and side-effects was the most found problem of PROMPT-QoL.Domain about getting drug information from health care providers wasfound the most found problem, followed by question comprehensionproblem. Eight of 42 questions had infit mean-squares and/or outfit meansquaresbelow 0.7 or above 1.3. Of nine domains, 5 domains had personreliability coefficients below 0.80. Conclusion: Most items of PROMPT-QoLhad favorable fit to the Rasch model. Further studies in large patientgroups are required to test its complete psychometric properties.Keywords: patient-reported outcomes, pretesting, cognitive interviews,Rasch mode

Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: Patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial

BACKGROUND: In the phase III CheckMate 227 study, first-line nivolumab + ipilimumab significantly prolonged progression-free survival (co-primary end-point) versus chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) and high tumour mutational burden (TMB; ≥10 mutations/megabase). AIM: To evaluate patient-reported outcomes (PROs) in this population. METHODS: Disease-related symptoms and general health status were assessed using the validated PRO questionnaires Lung Cancer Symptom Scale (LCSS) and EQ-5D, respectively. LCSS average symptom burden index (ASBI) and three-item global index (3-IGI) and EQ-5D visual analogue scale (VAS) and utility index (UI) scores and changes from baseline were analysed descriptively. Longitudinal changes were assessed by mixed-effect model repeated measures (MMRMs) and time to first deterioration/improvement analyses. RESULTS: In the high TMB population, PRO questionnaire completion rates were ∼90% at baseline and \u3e80% for most on-treatment assessments. During treatment, mean changes from baseline with nivolumab + ipilimumab showed early, clinically meaningful improvements in LCSS ASBI/3-IGI and EQ-5D VAS/UI; with chemotherapy, symptoms and health-related quality of life remained stable (LCSS ASBI/3-IGI, EQ-5D UI) or improved following induction (EQ-5D VAS). MMRM-assessed changes in symptom burden were improved with nivolumab + ipilimumab versus chemotherapy. Symptom deterioration by week 12 was lower with nivolumab + ipilimumab versus chemotherapy (22.3% versus 35.0%; absolute risk reduction: 12.7% [95% confidence interval 2.4-22.5]), irrespective of discontinuation. Time to first deterioration was delayed with nivolumab + ipilimumab versus chemotherapy across LCSS and EQ-5D summary measures. CONCLUSION: First-line nivolumab + ipilimumab demonstrated early, sustained improvements in PROs versus chemotherapy in patients with advanced NSCLC and high TMB. CLINICAL TRIAL REGISTRATION: NCT02477826

Quality of life in patients with CRB1-associated retinal dystrophies:A longitudinal study

Purpose: To assess the longitudinal vision-related quality of life among patients with CRB1-associated inherited retinal dystrophies. Methods: A longitudinal questionnaire study included 22 patients with pathogenic CRB1 variants. The National Eye Institute Visual Function Questionnaire (39 items, NEI VFQ-39) was applied at baseline, two-year follow-up, and 4-year follow-up. Classical test theory was performed to obtain subdomain scores and in particular ‘near activities’ and ‘total composite’ scores. The Rasch analysis based on previous calibrations of the NEI VFQ-25 was applied to create visual functioning and socio-emotional subscales. Results:In total, 22 patients with pathogenic CRB1 variants were included, with a median age of 25.0 years (IQR: 13–31 years) at baseline and mean follow-up of 4.0 ± 0.3 years. A significant decline at 4 years was observed for ‘near activities’ (51.0 ± 23.8 vs 35.4 ± 14.7, p = 0.004) and ‘total composite’ (63.0 ± 13.1 vs 52.0 ± 12.1, p = 0.001) subdomain scores. For the Rasch-scaled scores, the ‘visual functioning’ scale significantly decreased after 4 years (−0.89 logits; p = 0.012), but not at 4-year follow-up (+0.01 logits; p = 0.975). The ‘socio-emotional’ scale also showed a significant decline after 2 years (−0.78 logits, p = 0.033) and 4 years (−0.83 logits, p = 0.021). Conclusion: In the absence of an intervention, a decline in vision-related quality of life is present in patients with pathogenic CRB1 variants at 4-year follow-up. Patient-reported outcome measures should be included in future clinical trials, as they can be a potential indicator of disease progression and treatment efficacy.</p

Dimensionality and Measurement Invariance of the Italian Version of the EORTC QLQ-C30 in Postoperative Lung Cancer Patients

Background: This study aims to validate and evaluate the psychometric properties and measurement invariance of the Italian version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30), which is a measure of quality of life (QoL) for lung cancer patients after surgery. Methods: A total of 167 lung cancer patients completed the Italian version of the EORTC QLQ-C30 questionnaire at 30 days after they received a lobectomy. The factor structure of this scale was assessed by performing confirmatory factor analysis (CFA). Measurement invariance was evaluated by considering differential item functioning (DIF) due to age, gender, and type of surgery (i.e., robot- or not robot-assisted). Results: The CFA demonstrated the validity of the factor structure of the EORTC QLQ-C30 in assessing overall health and eight distinct subscales of adverse events and functioning. Moreover, the results highlighted a minimal DIF with only trivial consequences on measurement invariance. Specifically, the DIF did not affect the mean differences of latent scores of QoL between patients undergoing robot-assisted surgery or traditional surgery. Conclusion: These findings supported the validity and suitability of the EORTC QLQ-C30 for the assessment of QoL in lung cancer patients of diverse ages and genders undergoing lobectomy with or without robot-assisted surgery