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The TRIAL-STIM randomised controlled trial found no evidence that a spinal cord stimulation screening trial strategy provides superior patient outcomes compared to a no trial screening approach.
BackgroundIn England and Wales the two most likely places of death are hospitals (52%) and nursing homes (22%). The Department of Health published its National End of Life Care Strategy in July 2008 (Department of Health.End of Life Care Strategy: Promoting High Quality Care For All Adults at the End of Life. London: Department of Health; 2008) to improve the provision of care, recommending the use of the Liverpool Care Pathway for the Dying Patient (LCP).AimThe original aim was to assess the impact of the LCP on care in two settings: nursing homes and intensive care units (ICUs).DesignQualitative, matched case study.MethodsData were collected from 12 ICUs and 11 nursing homes in England: (1) documentary analysis of provider end-of-life care policy documents; (2) retrospective analysis of 10 deaths in each location using written case notes; (3) interviews with staff about end-of-life care; (4) observation of the care of dying patients; (5) analysis of the case notes pertaining to the observed patient’s death; (6) interview with a member of staff providing care during the observed period; (7) interview with a bereaved relative present during the observation; (8) economic analysis focused on the observed patients; and (9) strict inclusion and selection criteria for nursing homes and ICUs applied to match sites on LCP use/non-LCP use.ResultsIt was not possible to meet the stated aims of the study. Although 23 sites were recruited, observations were conducted in only 12 sites (eight using the LCP). A robust comparison on the basis of LCP use could not, therefore, take place. Although nurses in both settings reported that the LCP supported good care, the LCP was interpreted and used differently across sites, with the greatest variation in ICUs. Although not able to address the original research question, this study provides an unprecedented insight into care at the end of life in two different settings. The majority of nursing homes had implemented some kind of ‘pathway’ for dying patients and most homes participating in the observational stage were using the LCP. However, training in care of the dying was variable and specific issues were identified relating to general practitioner involvement, the use of anticipatory drugs and the assessment of consciousness and the swallowing reflex. In ICUs, end-of-life care was inextricably linked with the withdrawal of active treatment and controlling the pace of death. The data highlight how the decision to withdraw was made and, importantly, how relatives were involved in this process. The fact that most patients died soon after the withdrawal of interventions was reported to limit the appropriateness of the LCP in this setting.LimitationsAlthough the recruitment of matched sites was achieved, variable site participation resulted in a skewed sample. Issues with the sample size and a blurring of LCP use and non-use limit the extent to which the ambitious aims of the study were achieved.ConclusionsThis study makes a unique contribution to understanding the complexity of care at the end of life in two very different settings. More research is needed into the ways in which an organisational culture can be created within which the principles of good end-of-life care become translated into practice.FundingThe National Institute for Health Research Health Services and Delivery Research programme.
BackgroundTreatment with radioactive iodine is effective for many patients with progressive, locally advanced or metastatic, differentiated thyroid cancer. However, some patients become refractory to treatment. These types of patients are considered to have radioactive iodine refractory differentiated thyroid cancer (RR-DTC).MethodsWe searched Embase, MEDLINE, PubMed and the Cochrane Library from January 1999 through January 2017. Reference lists of included studies and ongoing trial registries were also searched. Reports of randomized controlled trials (RCTs), prospective observational studies, and systematic reviews/indirect comparisons were eligible for inclusion. In the absence of direct clinical trial evidence comparing lenvatinib versus sorafenib, we assessed the feasibility of conducting an indirect comparison to obtain estimates of the relative efficacy and safety of these two treatments.ResultsOf 2364 citations, in total, 93 papers reporting on 2 RCTs (primary evidence), 9 observational studies and 13 evidence reviews (supporting evidence) were identified. Compared to placebo, RCT evidence demonstrated improvements with lenvatinib or sorafenib in median progression-free survival (PFS) and objective tumour response rate (ORR). Overall survival (OS) was confounded by high treatment crossover (≥75%) in both trials. Adverse events (AEs) were more common with lenvatinib or sorafenib than with placebo but the most common AEs associated with each drug differed. Primarily due to differences in the survival risk profiles of patients in the placebo arms of the RCTs, we considered it inappropriate to indirectly compare the effectiveness of lenvatinib versus sorafenib. ORR and AE findings for lenvatinib and sorafenib from the supporting evidence were broadly in line with RCT evidence. Health-related quality of life (HRQoL) data were limited.ConclusionsLenvatinib and sorafenib are more efficacious than placebo (a proxy for best supportive care) for treating RR-DTC. Uncertainty surrounds the extent of the impact on OS and HRQoL. Lenvatinib could not reliably be compared with sorafenib. Choice of treatment is therefore likely to depend on an individual patient’s circumstances.
Second intravenous immunoglobulin dose in patients with Guillain-Barre syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial. Lancet Neurology, 20(4), 275-283.
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