Background Postmastectomy radiotherapy in patients with four or more positive axillary nodes reduces breast cancer mortality, but its role in patients with one to three involved nodes is controversial. We assessed the effects of postmastectomy radiotherapy on quality of life (QOL) in women with intermediate-risk breast cancer. MethodsSUPREMO is an open-label, international, parallel-group, randomised, controlled trial. Women aged 18 years or older with intermediate-risk breast cancer (defined as pT1-2N1; pT3N0; or pT2N0 if also grade III or with lymphovascular invasion) who had undergone mastectomy and, if node positive, axillary surgery, were randomly assigned (1:1) to receive chest wall radiotherapy (50 Gy in 25 fractions or a radiobiologically equivalent dose of 45 Gy in 20 fractions or 40 Gy in 15 fractions) or no radiotherapy. Randomisation was done with permuted blocks of varying block length, and stratified by centre, without masking of patients or investigators. The primary endpoint is 10-year overall survival. Here, we present 2-year results of QOL (a prespecified secondary endpoint). The QOL substudy, open to all UK patients, consists of questionnaires (European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23, Body Image Scale, Hospital Anxiety and Depression Scale [HADS], and EQ-5D-3L) completed before randomisation, and at 1, 2, 5, and 10 years. The prespecified primary outcomes within this QOL substudy were global QOL, fatigue, physical function, chest wall symptoms, shoulder and arm symptoms, body image, and anxiety and depression. Data were analysed by intention to treat, using repeated mixed-effects methods. This trial is registered with the ISRCTN registry, number ISRCTN61145589.Findings Between Aug 4, 2006, and April 29, 2013, 1688 patients were enrolled internationally and randomly assigned to receive chest wall radiotherapy (n=853) or not (n=835). 989 (79%) of 1258 patients from 111 UK centres consented to participate in the QOL substudy (487 in the radiotherapy group and 502 in the no radiotherapy group), of whom 947 (96%) returned the baseline questionnaires and were included in the analysis (radiotherapy, n=471; no radiotherapy, n=476). At up to 2 years, chest wall symptoms were worse in the radiotherapy group than in the no radiotherapy group (mean score 14·1 [SD 15·8] in the radiotherapy group vs 11·6 [14·6] in the no radiotherapy group; effect estimate 2·17, 95% CI 0·40-3·94; p=0·016); however, there was an improvement in both groups between years 1 and 2 (visit effect -1·34, 95% CI -2·36 to -0·31; p=0·010). No differences were seen between treatment groups in arm and shoulder symptoms, body image, fatigue, overall QOL, physical function, or anxiety or depression scores.Interpretation Postmastectomy radiotherapy led to more local (chest wall) symptoms up to 2 years postrandomisation compared with no radiotherapy, but the difference between groups was small. These data will inform shared decision making while we await survival (trial primary endpoint) results.
BackgroundDysvascular partial foot amputation (PFA) is a common sequel to advanced peripheral vascular disease. Helping inform difficult discussions between patients and practitioners about the level of PFA, or the decision to have a transtibial amputation (TTA) as an alternative, requires an understanding of the current research evidence on a wide range of topics including wound healing, reamputation, quality of life, mobility, functional ability, participation, pain and psychosocial outcomes, and mortality. The aim of this review was to describe a comprehensive range of outcomes of dysvascular PFA and compare these between levels of PFA and TTA.MethodsThe review protocol was registered in PROSPERO (CRD42015029186). A systematic search of the literature was conducted using MEDLINE, EMBASE, psychINFO, AMED, CINAHL, ProQuest Nursing and Allied Health, and Web of Science. These databases were searched using MeSH terms and keywords relating to different amputation levels and outcomes of interest. Peer reviewed studies of original research—irrespective of the study design—were included if published in English between 1 January 2000, and 31 December 2015, and included discrete cohort(s) with dysvascular PFA or PFA and TTA. Outcomes of interest were rate of wound healing and complications, rate of ipsilateral reamputation, quality of life, functional ability, mobility, pain (i.e., residual limb or phantom pain), psychosocial outcomes (i.e., depression, anxiety, body image and self-esteem), participation, and mortality rate. Included studies were independently appraised by two reviewers. The McMaster Critical Review Forms were used to assess methodological quality and identify sources of bias. Data were extracted based on the Cochrane Consumers and Communication Review Group’s data extraction template by a primary reviewer and checked for accuracy and clarity by a second reviewer. Findings are reported as narrative summaries given the heterogeneity of the literature, except for mortality and ipsilateral reamputation where data allowed for proportional meta-analyses.ResultsTwenty-nine unique articles were included in the review, acknowledging that some studies reported multiple outcomes. Eighteen studies reported all-cause proportionate mortality. A smaller number of studies reported outcomes related to functional ability (two), mobility (four), quality of life (three), ipsilateral reamputation (six) as well as wound healing and complications (four). No studies related to pain, participation or psychosocial outcomes met the inclusion criteria. Subjects were typically older and male and had diabetes among other comorbidities. More detailed information about the cohorts such as race or sociodemographic factors were reported in an ad hoc manner. Common sources of bias included contamination, co-intervention, or lack of operational definition for some outcomes (e.g., wound healing) as illustrative examples.ConclusionsAside from mortality, there was limited evidence regarding outcomes of dysvascular PFA, particularly how outc...
The similarity in quality of life between people with partial foot and transtibial amputation helps inform difficult decisions about amputation surgery by focusing on surgery that will reduce the risk of complications and secondary amputation without fear of compromising quality of life.
Seven individuals participated in each focus group. Prosthetists came from a mix of practice settings, while prosthesis users were diverse in level of amputation, aetiology, and years of experience using lower-limb prostheses. Residual limb problems reported by participants were consistent with those in the literature. Participants suggested better managing residual limb problems through improved education, better detection of residual limb problems, and using sensor-based information to improve prosthetic technology. Participants favoured short-term use of a possible residual limb monitoring systems to troubleshoot residual limb problems, with temperature and pressure the most frequently mentioned measurements. Participants described that an ideal residual limb monitoring system would be lightweight, not interfere with prosthesis function, and result in benefits with regard to prosthetic care and socket function that outweighed inconveniences or concerns regarding system use. A potential positive of system use included having objective data for reimbursement justification, although it was pointed out that the residual limb monitoring system itself also needed to be reimbursable. Implications for Rehabilitation Stakeholders suggested better managing residual limb problems through improved education, better detection of residual limb problems, and using sensor-based information to improve prosthetic technology. Stakeholders favored short-term use of a possible system to troubleshoot residual limb problems, with temperature and pressure the most frequently mentioned measurements. Stakeholders described that an ideal residual limb monitoring system would be lightweight, not interfere with prosthesis function, and result in benefits with regard to prosthetic care and socket function that outweighs any inconveniences or concerns regarding system use. Stakeholders indicated that a potential positive of system use included having objective data for reimbursement justification, although it was pointed out that the residual limb monitoring system itself also needed to be reimbursable.
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