20 research outputs found

    Feasibility of preoperative chemotherapy for locally advanced, operable colon cancer: The pilot phase of a randomised controlled trial

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    Summary: Background Preoperative (neoadjuvant) chemotherapy and radiotherapy are more eff ective than similar postoperative treatment for oesophageal, gastric, and rectal cancers, perhaps because of more eff ective micrometastasis eradication and reduced risk of incomplete excision and tumour cell shedding during surgery. The FOxTROT trial aims to investigate the feasibility, safety, and effi cacy of preoperative chemotherapy for colon cancer. Methods In the pilot stage of this randomised controlled trial, 150 patients with radiologically staged locally advanced (T3 with ≥5 mm invasion beyond the muscularis propria or T4) tumours from 35 UK centres were randomly assigned (2:1) to preoperative (three cycles of OxMdG [oxaliplatin 85 mg/m², l-folinic acid 175 mg, fl uorouracil 400 mg/m² bolus, then 2400 mg/m² by 46 h infusion] repeated at 2-weekly intervals followed by surgery and a further nine cycles of OxMdG) or standard postoperative chemotherapy (12 cycles of OxMdG). Patients with KRAS wild-type tumours were randomly assigned (1:1) to receive panitumumab (6 mg/kg; every 2 weeks with the fi rst 6 weeks of chemotherapy) or not. Treatment allocation was through a central randomisation service using a minimised randomisation procedure including age, radiological T and N stage, site of tumour, and presence of defunctioning colostomy as stratifi cation variables. Primary outcome measures of the pilot phase were feasibility, safety, and tolerance of preoperative therapy, and accuracy of radiological staging. Analysis was by intention to treat. This trial is registered, number ISRCTN 87163246. Findings 96% (95 of 99) of patients started and 89% (85 of 95) completed preoperative chemotherapy with grade 3–4 gastrointestinal toxicity in 7% (seven of 94) of patients. All 99 tumours in the preoperative group were resected, with no signifi cant diff erences in postoperative morbidity between the preoperative and control groups: 14% (14 of 99) versus 12% (six of 51) had complications prolonging hospital stay (p=0·81). 98% (50 of 51) of postoperative chemotherapy patients had T3 or more advanced tumours confi rmed at post-resection pathology compared with 91% (90 of 99) of patients following preoperative chemotherapy (p=0·10). Preoperative therapy resulted in signifi cant downstaging of TNM5 compared with the postoperative group (p=0·04), including two pathological complete responses, apical node involvement (1% [one of 98] vs 20% [ten of 50], p<0·0001), resection margin involvement (4% [ four of 99] vs 20% [ten of 50], p=0·002), and blinded centrally scored tumour regression grading: 31% (29 of 94) vs 2% (one of 46) moderate or greater regression (p=0·0001). Interpretation Preoperative chemotherapy for radiologically staged, locally advanced operable primary colon cancer is feasible with acceptable toxicity and perioperative morbidity. Proceeding to the phase 3 trial, to establish whether the encouraging pathological responses seen with preoperative therapy translates into improved long-term oncological outcome, is appropriate

    Is communication key in stroke rehabilitation and recovery? National linked stroke data study

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    Background: Information on the characteristics or long-term outcomes of people with communication support needs post-stroke is limited. We investigated associations between communication gains in rehabilitation and long-term outcomes (quality-of-life [EuroQOL-ED-3 L], mortality) by post-stroke communication support need status. Methods: Retrospective cohort study using person-level linked data from the Australian Stroke Clinical Registry and the Australasian Rehabilitation Outcomes Centre (2014–2017). Communication support needs were assessed using the Functional Independence Measure™ comprehension and expression items recorded on admission indicated by scores one (total assistance) to five (standby prompting). Multivariable multilevel and Cox regression models were used to determine associations with long-term outcomes. Results: Of 8,394 patients who received in-patient rehabilitation after stroke (42% female, median age 75.6 years), two-thirds had post-stroke communication support needs. Having aphasia (odds ratio [OR] 4.34, 95% CI 3.67–5.14), being aged ≥65 years (OR 1.21, 95% CI 1.08–1.36), greater stroke severity (unable to walk on admission; OR 1.48, 95% CI 1.32–1.68) and previous stroke (OR 1.25, 95% CI 1.11–1.41) were associated with increased likelihoods of having communication support needs. One-point improvement in FIM™ expression was associated with reduced likelihood of self-reporting problems related to mobility (OR 0.85, 95% CI: 0.80–0.90), self-care (OR 0.79, 95% CI: 0.74–0.86) or usual activities (OR 0.84, 95% CI: 0.75–0.94) at 90–180 days. Patients with communication support needs had greater mortality rates within one-year post-stroke (adjusted hazard ratio 1.99, 95% CI: 1.65–2.39). Conclusions: Two-thirds of patients with stroke require communication support to participate in healthcare activities. Establishing communication-accessible stroke care environments is a priority

    Quality of life is poorer for patients with stroke who require an interpreter : An observational Australian Registry study

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    Background and Purpose— In multicultural Australia, some patients with stroke cannot fully understand, or speak, English. Language barriers may reduce quality of care and consequent outcomes after stroke, yet little has been reported empirically. Methods— An observational study of patients with stroke or transient ischemic attack (2010–2015) captured from 45 hospitals participating in the Australian Stroke Clinical Registry. The use of interpreters in hospitals, which is routinely documented, was used as a proxy for severe language barriers. Health-Related Quality of Life was assessed using the EuroQoL-5 dimension-3 level measured 90 to 180 days after stroke. Logistic regression was undertaken to assess the association between domains of EuroQoL-5 dimension and interpreter status. Results— Among 34 562 registrants, 1461 (4.2%) required an interpreter. Compared with patients without interpreters, patients requiring an interpreter were more often women (53% versus 46%; P<0.001), aged ≥75 years (68% versus 51%; P<0.001), and had greater access to stroke unit care (85% versus 78%; P<0.001). After accounting for patient characteristics and stroke severity, patients requiring interpreters had comparable discharge outcomes (eg, mortality, discharged to rehabilitation) to patients not needing interpreters. However, these patients reported poorer Health-Related Quality of Life (visual analogue scale coefficient, −9; 95% CI, −12.38, −5.62), including more problems with self-care (odds ratio: 2.22; 95% CI, 1.82, 2.72), pain (odds ratio: 1.84; 95% CI, 1.52, 2.34), anxiety or depression (odds ratio: 1.60; 95% CI, 1.33, 1.93), and usual activities (odds ratio: 1.62; 95% CI, 1.32, 2.00). Conclusions— Patients requiring interpreters reported poorer Health Related Quality of Life after stroke/transient ischemic attack despite greater access to stroke units. These findings should be interpreted with caution because we are unable to account for prestroke Health Related Quality of Life. Further research is needed

    Better outcomes for hospitalized patients with TIA when in stroke units: an observational study

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    Objectives:To investigate differences in management and outcomes for patients admitted to the hospital with TIA according to care on a stroke unit (SU) or alternate ward setting up to 180 days post event.Methods:TIA admissions from 40 hospitals participating in the Australian Stroke Clinical Registry during 2010-2013 were assessed. Propensity score matching was used to assess outcomes by treatment group including Cox proportional hazards regression to compare survival differences and other appropriate multivariable regression models for outcomes including health-related quality of life and readmissions.Results:Among 3,007 patients with TIA (mean age 73 years, 54% male), 1,110 pairs could be matched. Compared to management elsewhere in hospitals, management in an SU was associated with improved cumulative survival at 180 days post event (hazard ratio 0.57, 95% confidence interval 0.35-0.94; p = 0.029), despite not being statistically significant at 90 days (hazard ratio 0.66, 95% confidence interval 0.33-1.31; p = 0.237). Overall, there were no differences for being discharged on antihypertensive medication or with a care plan, and the 90- to 180-day self-reported outcomes between these groups were similar. In subgroup analyses of 461 matched pairs treated in hospitals in one Australian state (Queensland), patients treated in an SU were more often prescribed aspirin within 48 hours (73% vs 62%, p < 0.001) and discharged on antithrombotic medications (84% vs 71%, p < 0.001) than those not treated in an SU.Conclusions:Hospitalized patients with TIA managed in SUs had better survival at 180 days than those treated in alternate wards, potentially through better management, but further research is needed

    Prescription of antihypertensive medication at discharge influences survival following stroke

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    To investigate the risk of death from cardiovascular disease between patients who were and were not prescribed antihypertensive medication following stroke or TIA.This was a large cohort study using routinely collected prospective data from the Australian Stroke Clinical Registry. Patients registered between 2009 and 2013 who were discharged to the community or rehabilitation were included. Cases were linked to the National Death Index to determine the date and cause of death. Propensity score matching with stratification was utilized to compare between similar subgroups of patients. Multivariable competing risks regression, with noncardiovascular death as a competing risk, was conducted to investigate the association between the prescription of antihypertensive medications and cardiovascular death at 180 days after admission.Among 12,198 patients from 40 hospitals, 70% were prescribed antihypertensive medications. Patients who were older, were treated in a stroke unit, and had better socioeconomic position were more often discharged from hospital with an antihypertensive medication. Including only patients within propensity score quintiles with acceptable levels of balance in covariates between groups (n = 8,786), prescription of antihypertensive medications was associated with a 23% greater reduction in the subhazard of cardiovascular death compared to those who were not prescribed these agents (subhazard ratio 0.77; 95% confidence interval 0.61 to 0.97).People who are prescribed antihypertensive medications at discharge from hospital after a stroke or TIA demonstrate better cardiovascular and all-cause survival outcomes than those not prescribed these agents
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