Background The clinical significance of circulating tumour cells (CTCs) in limited-stage small-cell lung cancer (LS-SCLC) is not well defined. We report a planned exploratory analysis of the prevalence and prognostic value of CTCs in LS-SCLC patients enrolled within the phase III randomised CONVERT (concurrent once-daily versus twice-daily chemoradiotherapy) trial. Patients and methods Baseline blood samples were enumerated for CTCs using CellSearch in 75 patients with LS-SCLC who were enrolled in the CONVERT trial and randomised between twice- and once-daily concurrent chemoradiation. Standard statistical methods were used for correlations of CTCs with clinical factors. Log-rank test and Cox regression analyses were applied to establish the associations of 2, 15 and 50 CTC thresholds with progression-free survival (PFS) and overall survival (OS). An optimal CTC count threshold for LS-SCLC was established. Results CTCs were detected in 60% (45/75) of patients (range 0–3750). CTC count thresholds of 2, 15 and 50 CTCs all significantly correlate with PFS and OS. An optimal CTC count threshold in LS-SCLC was established at 15 CTCs, defining ‘favourable’ and ‘unfavourable’ prognostic risk groups. The median OS in <15 versus ≥15 CTCs was 26.7 versus 5.9 m ( P = 0.001). The presence of ≥15 CTCs at baseline independently predicted ≤1 year survival in 70% and ≤2 years survival in 100% of patients. Conclusion We report the prognostic value of baseline CTC count in an exclusive LS-SCLC population at thresholds of 2, 15 and 50 CTCs. Specific to LS-SCLC, ≥15 CTCs was associated with worse PFS and OS independent of all other factors and predicted ≤2 years survival. These results may improve disease stratification in future clinical trial designs and aid clinical decision making. Trial registration ClinicalTrials.gov identifier: NCT00433563.
Background As many as 30% of patients who start pulmonary rehabilitation (PR) fail to complete it, and depressed mood has been associated with PR non-completion. Depression is more common in women than men with COPD and historically women with COPD have been under studied. However, no studies to date have investigated gender-specific predictors of PR completion. Methods The study included 111 patients with COPD who enrolled in a community based outpatient PR program in Providence, RI. Patients who attended 20 or more sessions were designated “completers.” Depression was measured using the CES-D. Logistic regression models were evaluated to test depressed mood as a predictor of PR completion. Analyses controlled for demographic and health variables found to differ between completers and non-completers. Results Patients were 95% white and 49.5% women, and 74% had a GOLD stage ≥ 3. Sixty-eight percent of patients were PR completers. A logistic regression model, showed that lower depressed mood independently predicted PR completion across all patients (adjusted OR = 0.92, p = .002). In gender-stratified analyses, lower depressed mood was an independent predictor of PR completion for women (adjusted OR = 0.91, p = .024) but not men (adjusted OR = 0.97, p = .45). Greater six-minute walk test distance was also an independent predictor of PR completion among women. Conclusion Depressed mood is an important predictor of completion of community based PR among women. Screening and brief treatment of depression should be considered in practice.
IntroductionThis protocol is describing a multicentre, single-blind randomised controlled trial. The objective is to compare the efficacy of MyndMove therapy versus conventional therapy (CT) in improving upper extremity function in individuals with C4–C7 traumatic, incomplete spinal cord injury (SCI). It is being conducted in two US and two Canadian SCI rehabilitation centres.Methods and analysisSixty people aged 18 years or older with a C4–C7 incomplete (AIS B-D) SCI between 4 months and 8 years postinjury are randomised to receive 40 sessions of MyndMove neuromodulation therapy or CT within a 14-week period of time. Therapy sessions are 1 hour in duration with a dose of 3–5 sessions per week. Assessments occur prior to randomisation, after 20 sessions, after 40 sessions and 10 weeks after the last session. The primary outcome measure is the efficacy of MyndMove therapy versus CT in improving upper extremity function as measured by Spinal Cord Independence Measure III: Self-Care subscore after 40 sessions. Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation.Ethics and disseminationAll ethical approvals were obtained prior to enrolling any participants. Dissemination of the results of the study will be made at peer-reviewed academic meetings and through peer-reviewed medical journalsTrial registration numberNCT03439319
Introduction Exercise modalities offered as part of traditional pulmonary rehabilitation (PR) do not always translate to successful performance of Activities of Daily Living (ADL) and may hinder gains in patient's sense of well-being. Data is lacking on the efficacy of incorporation of ADLfocused training in PR. The aim of this study was to determine the impact of incorporation of ADL simulation and energy-conservation training in PR as part of a quality-initiative on health-related-quality-of-life (HRQOL), dyspnea, fatigue, and six-minute-walk-test among PR patients. Methods Retrospective study where medical records of consecutive patients with chronic respiratory diseases who completed PR from 2016 to 2018 were reviewed. ADL-focused energy-conservation training was added to traditional PR in September 2017 by replacing three monthly sessions of traditional PR with energy-conservation training as a quality-improvement-initiative. The change from baseline on HRQOL measured by COPD assessment test (CAT), six-minute-walk-test, MMRC dyspnea score and CRQ-dyspnea and CRQ-fatigue questionnaires, were compared between patients who received traditional PR versus energy-conservation PR. Within and between group differences were calculated via repeated-measures ANOVA. Results The baseline characteristics of 91 patients who participated in traditional PR versus energyconservation PR (n = 85) were similar (mean age = 68.6±10.4 years, 49% men). While improvement from baseline was similar and significant for both groups for MMRC, CRQdyspnea and CRQ-fatigue scores, and six-minute walk test, patients who participated in
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