Dataset Information

Protocol for a multicentre, prospective, cohort study to investigate patient satisfaction and quality of life after immediate breast reconstruction in Japan: the SAQLA study.

ABSTRACT:

Introduction

The aim of breast reconstruction (BR) is to improve patients' health-related quality of life (HRQOL). Therefore, measuring patient-reported outcomes (PROs) would clarify the value and impact of BR on a patient's life and thus would provide evidence-based information to help decision-making. The Satisfaction and Quality of Life After Immediate Breast Reconstruction study aimed to investigate satisfaction and HRQOL in Japanese patients with breast cancer who undergo immediate breast reconstruction (IBR).

Methods and analysis

This ongoing prospective, observational multicentre study will assess 406 patients who had unilateral breast cancer and underwent mastectomy and IBR, and were recruited from April 2018 to July 2019. All participants were recruited from seven hospitals: Okayama University Hospital, Iwate Medical University Hospital, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Showa University Hospital, University of Tsukuba Hospital, Osaka University Hospital and Yokohama City University Medical Center. The patients will be followed up for 36 months postoperatively. The primary endpoint of this study will be the time-dependent changes in BREAST-Q satisfaction with breast subscale scores for 12 months after reconstructive surgery, which will be collected via an electronic PRO system.

Ethics and dissemination

This study will be performed in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan's Ministry of Education, Science and Technology and the Ministry of Health, Labour and Welfare, the modified Act on the Protection of Personal Information and the Declaration of Helsinki. This study protocol was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, on 2 February 2018 (1801-039) and all other participating sites. The findings of this trial will be submitted to an international peer-reviewed journal.

Trial registration number

UMIN000032177.

SUBMITTER: Saiga M

PROVIDER: S-EPMC7887355 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Protocol for a multicentre, prospective, cohort study to investigate patient satisfaction and quality of life after immediate breast reconstruction in Japan: the SAQLA study.

Saiga Miho M Hosoya Yuko Y Utsunomiya Hiroki H Kuramoto Yukiko Y Watanabe Satoko S Tomita Koichi K Aihara Yukiko Y Muto Mayu M Hikosaka Makoto M Kawaguchi Takashi T Miyaji Tempei T Yamaguchi Takuhiro T Zenda Sadamoto S Goto Aya A Sakuraba Minoru M Kusano Taro T Miyabe Kenta K Kuroki Tomoaki T Yano Tomoyuki T Taminato Mifue M Sekido Mitsuru M Tsunoda Yui Y Satake Toshihiko T Doihara Hiroyoshi H Kimata Yoshihiro Y

BMJ open 20210215 2

<h4>Introduction</h4>The aim of breast reconstruction (BR) is to improve patients' health-related quality of life (HRQOL). Therefore, measuring patient-reported outcomes (PROs) would clarify the value and impact of BR on a patient's life and thus would provide evidence-based information to help decision-making. The Satisfaction and Quality of Life After Immediate Breast Reconstruction study aimed to investigate satisfaction and HRQOL in Japanese patients with breast cancer who undergo immediate ...[more]

PMID: 33589456

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Project description:BackgroundThe management of early breast cancer (BC) with skin-sparing mastectomy (SSM) and immediate breast reconstruction (IBR) is not based on level-1 evidence. In this study, the oncological outcome, post-operative morbidity and patients' satisfaction with SSM and IBR using the latissimus dorsi (LD) myocutaneous flap and/or breast prosthesis is evaluated.Methods137 SSMs with IBR (10 bilateral) were undertaken in 127 consecutive women, using the LD flap plus implant (n = 85), LD flap alone (n = 1) or implant alone (n = 51), for early BC (n = 130) or prophylaxis (n = 7). Nipple reconstruction was performed in 69 patients, using the trefoil local flap technique (n = 61), nipple sharing (n = 6), skin graft (n = 1) and Monocryl mesh (n = 1). Thirty patients underwent contra-lateral procedures to enhance symmetry, including 19 augmentations and 11 mastopexy/reduction mammoplasties. A linear visual analogue scale was used to assess patient satisfaction with surgical outcome, ranging from 0 (not satisfied) to 10 (most satisfied).ResultsAfter a median follow-up of 36 months (range = 6-101 months) there were no local recurrences. Overall breast cancer specific survival was 99.2%, 8 patients developed distant disease and 1 died of metastatic BC. There were no cases of partial or total LD flap loss. Morbidities included infection, requiring implant removal in 2 patients and 1 patient developed marginal ischaemia of the skin envelope. Chemotherapy was delayed in 1 patient due to infection. Significant capsule formation, requiring capsulotomy, was observed in 85% of patients who had either post-mastectomy radiotherapy (PMR) or prior radiotherapy (RT) compared with 13% for those who had not received RT. The outcome questionnaire was completed by 82 (64.6%) of 127 patients with a median satisfaction score of 9 (range = 5-10).ConclusionSSM with IBR is associated with low morbidity, high levels of patient satisfaction and is oncologically safe for T(is), T1 and T2 tumours without extensive skin involvement.

Project description:BackgroundUse of biological or synthetic mesh might improve outcomes of immediate implant-based breast reconstruction-breast reconstruction with implants or expanders at the time of mastectomy-but there is a lack of high-quality evidence to support the safety or effectiveness of the technique. We aimed to establish the short-term safety of immediate implant-based breast reconstruction performed with and without mesh, to inform the feasibility of undertaking a future randomised clinical trial comparing different breast reconstruction techniques.MethodsIn this prospective, multicentre cohort study, we consecutively recruited women aged 16 years or older who had any type of immediate implant-based breast reconstruction for malignancy or risk reduction, with any technique, at 81 participating breast and plastic surgical units in the UK. Data about patient demographics and operative, oncological, and complication details were collected before and after surgery. Outcomes of interest were implant loss (defined as unplanned removal of the expander or implant), infection requiring treatment with antibiotics or surgery, unplanned return to theatre, and unplanned re-admission to hospital for complications of reconstructive surgery, up to 3 months after reconstruction and assessed by clinical review or patient self-report. Follow-up is complete. The study is registered with the ISRCTN Registry, number ISRCTN37664281.FindingsBetween Feb 1, 2014, and June 30, 2016, 2108 patients had 2655 mastectomies with immediate implant-based breast reconstruction at 81 units across the UK. 1650 (78%) patients had planned single-stage reconstructions (including 12 patients who had a different technique per breast). 1376 (65%) patients had reconstruction with biological (1133 [54%]) or synthetic (243 [12%]) mesh, 181 (9%) had non-mesh submuscular or subfascial implants, 440 (21%) had dermal sling implants, 42 (2%) had pre-pectoral implants, and 79 (4%) had other or a combination of implants. 3-month outcome data were available for 2081 (99%) patients. Of these patients, 182 (9%, 95% CI 8-10) experienced implant loss, 372 (18%, 16-20) required re-admission to hospital, and 370 (18%, 16-20) required return to theatre for complications within 3 months of their initial surgery. 522 (25%, 95% CI 23-27) patients required treatment for an infection. The rates of all of these complications are higher than those in the National Quality Standards (<5% for re-operation, re-admission, and implant loss, and <10% for infection).InterpretationComplications after immediate implant-based breast reconstruction are higher than recommended by national standards. A randomised clinical trial is needed to establish the optimal approach to immediate implant-based breast reconstruction.FundingNational Institute for Health Research, Association of Breast Surgery, and British Association of Plastic, Reconstructive and Aesthetic Surgeons.

Project description:IntroductionMortality amongst COPD patients treated on the ICU is high. Health-related quality of life (HRQL) after intensive care is a relevant concern for COPD patients, their families and providers of health care. Still, there are few HRQL studies after intensive care of this patient group. Our hypothesis was that HRQL of COPD patients treated on the ICU declines rapidly with time.MethodsFifty-one COPD patients (COPD-ICU group) with an ICU stay longer than 24 hours received a questionnaire at 6, 12 and 24 months after discharge from ICU. HRQL was measured using two generic instruments: the EuroQoL instrument (EQ-5D and EQ-VAS) and the Short Form 36 Health Survey (SF-36). The results were compared to HRQL of two reference groups from the general population; an age- and sex-adjusted reference population (Non-COPD reference) and a reference group with COPD (COPD reference).ResultsHRQL of the COPD-ICU group at 6 months after discharge from ICU was lower compared to the COPD reference group: Median EQ-5D was 0.66 vs. 0.73, P = 0.08 and median EQ-VAS was 50 vs.55, P < 0.05. There were no significant differences in the SF-36 dimensions between the COPD-ICU and COPD-reference groups, although the difference in physical functioning (PF) approached statistical significance (P = 0.059). Patients in the COPD-ICU group who were lost to follow-up after 6 months had low HRQL scores at 6 months. Scores for patients who died were generally lower compared to patients who failed to respond to the questionnaire. The PF and social functioning (SF) scores in those who died were significantly lower compared to patients with a complete follow up. HRQL of patients in the COPD-ICU group that survived a complete 24 months follow up was low but stable with no statistically significant decline from 6 to 24 months after ICU discharge. Their HRQL at 24 months was not significantly different from HRQL in the COPD reference group.ConclusionsHRQL in COPD survivors after intensive care was low but did not decline from 6 to 24 months after discharge from ICU. Furthermore, HRQL at 24 months was similar to patients with COPD who had not received ICU treatment.

Project description:ObjectiveWomen have reported higher mortality and major adverse cardiovascular events (MACE) following acute coronary syndromes (ACSs) compared with men. With this in mind, we aimed to identify predictors of poor quality of life (QoL) post-ACS as our primary outcome. We examined predictors of MACE, major cerebrovascular events and major bleeding as our secondary outcome.DesignProspective cohort study.Setting30 metropolitan centres across the Victorian Cardiac Outcomes Registry network.Participants16?517 patients treated with percutaneous coronary intervention (PCI) for ACS (22.9% females). Selection/inclusion criteria: consecutive patients with successful or attempted PCI for ACS from 2013 to 2016, alive at 30?days post-PCI.Exclusion criteriapatients not fulfilling ACS criteria. At 30?days, 2497 (64.7% females) completed the QoL EQ-5D-3L instrument.Primary and secondary outcome measuresQoL, assessed using the EuroQo-5Dimensions (EQ-5D-3L) instrument by telephone at 30 days. Independent predictors of QoL were identified by univariate and multivariate logistic regression analyses.ResultsWomen were significantly older with more diabetes, cerebrovascular disease and renal failure. Regarding the primary outcome, female sex was independently associated with moderate/severe impairment in all EQ-5D-3L domains including mobility (OR 2.38, 95%?CI 2.06 to 2.75, p<0.001), personal care (OR 2.14, 95%?CI 1.73 to 2.66, p<0.001), activities of daily living (OR 1.84, 95%?CI 1.63 to 2.08, p<0.001), pain/discomfort (OR 1.44, 95%?CI 1.24 to 1.67, p<0.001) and anxiety/depression (OR 1.49, 95%?CI 1.30 to 1.70, p<0.001). Women had significantly lower self-rated Visual Analogue Scale scores (80.0 for both groups, IQR 60-85 vs 70-90, p<0.001). There was no significant difference between the sexes in secondary outcomes.ConclusionsFemale sex was a predictor of poorer QoL following PCI for ACS including significantly higher pain, anxiety and depression. This was independent of age, comorbidities and ACS presentation. There is a clinical need for a tailored approach in female ACS management, for example, emphasis on management of depressive and anxiety symptoms.

Project description:ObjectiveTo evaluate health-related quality of life (HRQOL), mood, and patient satisfaction in epilepsy surgery candidates before and 2 years after epilepsy surgery or presurgical investigation.MethodsIn this prospective study of 141 patients, 96 underwent surgery and 45 did not. Questionnaires at baseline and at 2-year follow-up included the generic 36-item Short Form Health Survey (SF-36), the Hospital Anxiety and Depression scale (HAD), and operated patients answered patient satisfaction questions. SF-36 scores were compared with scores from a matched sample from the Swedish norm population. Numbers were calculated of patients achieving a minimum important change (MIC) in the SF-36 Physical Composite Summary (PCS) and Mental Composite Summary (MCS).ResultsAt baseline, patients had significantly lower values than the norm on all SF-36 domains. At follow-up, operated patients were divided into seizure-free (International League Against Epilepsy [ILAE] class 1 and 2, n = 53) or with continued seizures (n = 43). No differences in baseline HAD or SF-36 values were found between these groups. Seizure-free patients reached the same levels as the norm in all SF-36 domains except Social Function. Operated patients with continued seizures and nonoperated patients had unchanged scores. Fifty-one percent of seizure-free patients had an improvement reaching MIC for PCS and 45% for MCS. Corresponding results for patients with continued seizures were 28% in PCS and 28% in MCS, for nonoperated 33% in PCS and 29% in MCS. HAD anxiety scores improved significantly in only the seizure-free patients. Of all operated patients, 80% were satisfied with having had surgery and 86% considered that they had benefited, whereas 20% thought that surgery caused some harm.SignificanceIn patients who were seizure-free after epilepsy surgery HRQOL normalized and anxiety decreased. Operated patients overwhelmingly considered epilepsy surgery to be beneficial. Nonetheless, only about half of the seizure-free patients achieved important HRQOL improvements, suggesting that seizure freedom does not in and of itself guarantee improved patient well-being. A PowerPoint slide summarizing this article is available for download in the Supporting Information section here.

Dataset Information

Protocol for a multicentre, prospective, cohort study to investigate patient satisfaction and quality of life after immediate breast reconstruction in Japan: the SAQLA study.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Protocol for a multicentre, prospective, cohort study to investigate patient satisfaction and quality of life after immediate breast reconstruction in Japan: the SAQLA study.

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