Very early versus delayed mobilisation after stroke.
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ABSTRACT:
SUBMITTER: Langhorne P
PROVIDER: S-EPMC6517132 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesWhile very early mobilisation (VEM) intervention for stroke patients was shown not to be effective at 3 months, 12 month clinical and economical outcomes remain unknown. The aim was to assess cost-effectiveness of a VEM intervention within a phase III randomised controlled trial (RCT).DesignAn economic evaluation alongside a RCT, and detailed resource use and cost analysis over 12 months post-acute stroke.SettingMulti-country RCT involved 58 stroke centres.Participants2104 patients with acute stroke who were admitted to a stroke unit.InterventionA very early rehabilitation intervention within 24 hours of stroke onset METHODS: Cost-utility analyses were undertaken according to pre-specified protocol measuring VEM against usual care (UC) based on 12 month outcomes. The analysis was conducted using both health sector and societal perspectives. Unit costs were sourced from participating countries. Details on resource use (both health and non-health) were sourced from cost case report form. Dichotomised modified Rankin Scale (mRS) scores (0 to 2 vs 3 to 6) and quality adjusted-life years (QALYs) were used to compare the treatment effect of VEM and UC. The base case analysis was performed on an intention-to-treat basis and 95% CI for cost and QALYs were estimated by bootstrapping. Sensitivity analysis were conducted to examine the robustness of base case results.ResultsVEM and UC groups were comparable in the quantity of resource use and cost of each component. There were no differences in the probability of achieving a favourable mRS outcome (0.030, 95% CI -0.022 to 0.082), QALYs (0.013, 95% CI -0.041 to 0.016) and cost (AUD1082, 95% CI -$2520 to $4685 from a health sector perspective or AUD102, 95% CI -$6907 to $7111, from a societal perspective including productivity cost). Sensitivity analysis achieved results with mostly overlapped CIs.ConclusionsVEM and UC were associated with comparable costs, mRS outcome and QALY gains at 12 months. Compared with to UC, VEM is unlikely to be cost-effective. The long-term data collection during the trial also informed resource use and cost of care post-acute stroke across five participating countries.Trial registration numberACTRN12606000185561; Results.
| S-EPMC6537993 | biostudies-literature
Project description:Background Although it is traditionally regarded as a single entity, perioperative stroke comprises 2 separate phenomena (early/intraoperative and delayed/postoperative stroke). We aimed to systematically evaluate incidence, risk factors, and clinical outcome of early and delayed stroke after cardiac surgery. Methods and Results A systematic review ( MEDLINE , EMBASE , Cochrane Library) was performed to identify all articles reporting early (on awakening from anesthesia) and delayed (after normal awakening from anesthesia) stroke after cardiac surgery. End points were pooled event rates of stroke and operative mortality and incident rate of late mortality. Thirty-six articles were included (174 969 patients). The pooled event rate for early stroke was 0.98% (95% CI 0.79% to 1.23%) and was 0.93% for delayed stoke (95% CI 0.77% to 1.11%; P=0.68). The pooled event rate of operative mortality was 28.8% (95% CI 17.6% to 43.4%) for early and 17.9% (95% CI 14.0% to 22.7%) for delayed stroke, compared with 2.4% (95% CI 1.9% to 3.1%) for patients without stroke ( P<0.001 for early versus delayed, and for perioperative stroke, early stroke, and delayed stroke versus no stroke). At a mean follow-up of 8.25 years, the incident rate of late mortality was 11.7% (95% CI 7.5% to 18.3%) for early and 9.4% (95% CI 5.9% to 14.9%) for delayed stroke, compared with 3.4% (95% CI 2.4% to 4.8%) in patients with no stroke. Meta-regression demonstrated that off-pump was inversely associated with early stroke (β=-0.009, P=0.01), whereas previous stroke (β=0.02, P<0.001) was associated with delayed stroke. Conclusions Early and delayed stroke after cardiac surgery have different risk factors and impacts on operative mortality as well as on long-term survival.
| S-EPMC6662344 | biostudies-literature
Project description:Rotator cuff tears are a common cause for pain and reduced function. Tears of the tendons of the cuff can be a result of a degenerative process or as a consequence of trauma. Management of cuff tears are surrounded by controversy from indications for surgical management to rehabilitation protocol post-surgical repair. The aim of post surgical rehabilitation is to improve functional outcome, reduce pain and promote tendon healing. In the case of rotator cuff repair, rehabilitation can be broadly divided into early passive range of motion (EPM) and delayed range of motion (DRM). The EPM regime is defined by minimal immobilisation of the shoulder and passive mobilisation of the joint within the first post-operative period. In contrast, DRM immobilises the shoulder joint up to six weeks post-operatively. Proponents of EPM state various advantages of their rehabilitation protocol including improved range of motion and earlier return to normal activities of daily living. However, there has also been concern that this rehabilitation regime may result in an increased rate of re-rupture. Since this is a highly controversial issue, various high quality literature have been published looking to clarify which regime is best following rotator cuff surgery. Reviewing these articles, it appears that there is an increase rate of re-tear of the repaired rotator cuff tendon when the EPM regime is employed. Statistical significance however was limited by small sample sizes. Range of motion post-repair also appears to be associated with post-operative rehabilitation regime. As expected, the EPM regime has been shown to improve range of motion post-repair. Despite this, literature reports patients managed with the DPM showed a statistically better patient reported outcome measure. We conclude that based on the evidence we currently have, early range of motion post rotator cuff repair is related with an increase risk of re-tear. The DPM regime reduces this risk with the possible complication of reduced range of shoulder movement. This problem is thought to be an easier clinical issue to deal with compared to re-rupture of the repaired rotator cuff tendon. There is however lack of data to achieve statistical significance in most of these analysis. There is a definite need for a large, multi-centre single blinded randomised controlled trial to further shed light on this controversial topic.
| S-EPMC6382997 | biostudies-literature
Project description:BackgroundPancreatic ductal adenocarcinoma (PDAC) is a highly aggressive tumor showing a tendency for early recurrence, even after curative resection. Although adjuvant treatment improves survival, it is unclear whether early adjuvant treatment initiation yields better outcomes in patients with PDAC.MethodsWe retrospectively enrolled 113 patients who underwent chemotherapy or chemoradiotherapy after curative resection of PDAC: Fifty-six and 57 patients were in the early and delayed groups, respectively based on the median time of treatment initiation (35 days [range, 20-83 days]).ResultsPatient baseline characteristics were comparable in both groups, except for grade III or IV postoperative complications (5.4% in the early group vs. 22.8% in the delayed group). With a median 20.3-month follow-up, the overall survival (OS) and disease-free survival (DFS) times were 29.5 and 14.7 months, respectively. The early group had significantly prolonged OS (39.1 vs. 21.1 months, p = 0.018) and DFS (18.8 vs. 10.0 months, p = 0.034), compared to the delayed group. Among 71 patients who completed planned adjuvant treatment, patients in the early group tended to have longer, though not statistically significant, OS and DFS times than those in the delayed group. In 67 patients without postoperative complications, patients in the early group had longer OS (42.8 vs. 20.5 months, p = 0.002) and DFS (19.6 vs. 9.1 months, p = 0.005) than those in the delayed group. By multivariate analysis, incompletion of treatment (hazard ratio [HR]: 4.039, 95% confidence interval [CI]: 2.334-6.992), delayed treatment initiation (HR: 1.822, 95% CI: 1.081-3.070), and positive angiolymphatic invasion (HR: 2.116, 95% CI: 1.160-3.862) were significantly associated with shorter OS.ConclusionsAdjuvant treatment should be delivered earlier and completed for better outcomes in resected PDAC patients, especially without postoperative complications.
| S-EPMC5354454 | biostudies-literature
Project description: Not available
| S-EPMC6984627 | biostudies-literature
Project description:BackgroundStroke is the disease with the highest costs for hospital care and also after discharge. Early supported discharge (ESD) has shown to be efficient and safe and the best results with well-organised discharge teams and patients with less severe strokes. The aim is to investigate if very early supported discharge (VESD) for stroke patients in need for on-going individualised rehabilitation at home is useful for the patient and cost effective.Methods/designA randomized controlled trial comparing VESD with ordinary discharge.Inclusion criteriaconfirmed stroke, >18 years of age, living within 30 min from the stroke unit, on day 2 0-16 points on the National institute of health stroke scale (NIHSS) and 50-100 points on the Barthel Index (BI), with BI 100 then the patient can be included if the Montreal Cognitive Assessment is < 26. Exclusion criteria are: NIHSS >16, BI < 50, life expectancy < 1 year, inability to speak or to communicate in Swedish. The inclusion occurs on day 4 and in block randomization of 20 and with blinded assessor.Primary outcomelevels of anxiety and depression.Secondary outcomesindependence, security, level of function, quality of health, needs of support in activities of daily living and caregiver burden. Power calculation is based on the level of anxiety and with a power of 80%, p-value 0.05 (2 sided test) 44 persons per group are needed. Data is gathered on co-morbidity, re-entry to hospital, mortality and a health economic analysis. Interviews will be accomplished with a strategic sample of 15 patients in the intervention group before discharge, within two weeks after homecoming and 3 months later. Interviews are also planned with 15 relatives in the intervention group 3 months after discharge.DiscussionThe ESD studies in the Cochrane review present hospital stays of a length that no longer exist in Sweden. There is not yet, to our knowledge, any study of early supported discharge with present length of hospital stay. Thus it is not clear if home rehabilitation nowadays without risks, is cost effective, or with the same patient usefulness as earlier studies.Trial registrationClinicalTrials.gov NCT01622205.
| S-EPMC3694454 | biostudies-literature
Project description:BackgroundLittle is known regarding the effect of early active elbow range of motion (ROM) protocols on failure rates and outcomes after open subpectoral biceps tenodesis.HypothesisWe hypothesized that patients managed using an early active ROM protocol after open subpectoral biceps tenodesis would demonstrate similar failure rates and functional outcomes compared to patients managed using a traditional delayed active ROM protocol.Study designCohort study; Level of evidence, 3.MethodsWe evaluated 63 patients who underwent open subpectoral biceps tenodesis with unicortical suture button fixation. Based on surgeon preference, 22 patients were managed using an early active motion protocol consisting of no restrictions on elbow flexion or forearm supination, while 41 patients were managed using a delayed motion protocol postoperatively. Primary outcome measures included failure of biceps tenodesis and American Shoulder and Elbow Surgeons (ASES) and Single Assessment Numeric Evaluation (SANE) scores. Secondary outcomes included shoulder and elbow ROM at 6 months postoperatively.ResultsThe mean follow-up for the 63 patients was 24.2 months postoperatively. One patient (2.4%) in the delayed active motion cohort and no patients in the early active motion cohort experienced failure. Final outcome scores as well as 6-month shoulder and elbow ROM indicated excellent functional outcomes, with no significant difference between motion cohorts. The median postoperative ASES scores were 97.99 in the early active motion cohort (mean ± standard deviation [SD], 95.49 ± 7.68) and 95.42 in the delayed motion cohort (mean ± SD, 90.93 ± 16.08), while median postoperative SANE scores were 96 in the early motion cohort (mean ± SD, 94.23 ± 6.68) and 95 in the delayed motion cohort (mean ± SD, 88.39 ± 17.98). Subgroup analysis demonstrated no significant difference in outcome scores based on the performance of concomitant rotator cuff repair or hand dominance.ConclusionEarly active ROM after open subpectoral biceps tenodesis with unicortical suture button fixation resulted in low failure rates and excellent clinical outcomes, comparable to the results of patients managed using delayed active ROM protocols. This suggests that patients undergoing open subpectoral biceps tenodesis may be managed using either early or delayed active motion protocols without compromising functional outcome.
| S-EPMC8392820 | biostudies-literature
Project description:The pathophysiology underlying very late drug-eluting stent (DES) thrombosis is not sufficiently understood. Using optical coherence tomography, we investigated characteristics of very late stent thrombosis (VLST) according to different onset times. A total of 98 patients from 10 South Korean hospitals who underwent optical coherence tomography for evaluation of very late DES thrombosis were retrospectively included in analyses. VLST occurred at a median of 55.1 months after DES implantation. All patients were divided into 2 equal groups of earlier versus delayed presentation of VLST, according to median onset time. In total, 27 patients were treated with next-generation DES and 71 with first-generation DES. Based on optical coherence tomography findings at thrombotic sites, main VLST mechanisms were as follows, in descending order: neoatherosclerosis (34.7%), stent malapposition (33.7%), and uncovered struts without stent malapposition or evagination (24.5%). Compared with patients with earlier VLST, patients with delayed VLST had lower frequency of uncovered struts without stent malapposition or evagination (34.7% versus 14.3%, respectively; P=0.019). Conversely, the frequency of neoatherosclerosis was higher in patients with delayed versus earlier VLST (44.9% versus 24.5%, respectively; P=0.034). The frequency of stent malapposition was not different between patients with earlier and delayed VLST (34.7% versus 32.7%, respectively; P=0.831). The frequency of stent malapposition, evagination, and uncovered struts was still half of delayed VLST. The pathological mechanisms of very late DES thrombosis changed over time. Delayed neointimal healing remained a substantial substrate for VLST, even long after DES implantation.
| S-EPMC5533030 | biostudies-literature
Project description:Background and Purpose- Stenting for symptomatic carotid stenosis (carotid artery stenting [CAS]) carries a higher risk of procedural stroke or death than carotid endarterectomy (CEA). It is unclear whether this extra risk is present both on the day of procedure and within 1 to 30 days thereafter and whether clinical risk factors differ between these periods. Methods- We analyzed the risk of stroke or death occurring on the day of procedure (immediate procedural events) and within 1 to 30 days thereafter (delayed procedural events) in 4597 individual patients with symptomatic carotid stenosis who underwent CAS (n=2326) or CEA (n=2271) in 4 randomized trials. Results- Compared with CEA, patients treated with CAS were at greater risk for immediate procedural events (110 versus 42; 4.7% versus 1.9%; odds ratio, 2.6; 95% CI, 1.9-3.8) but not for delayed procedural events (59 versus 46; 2.5% versus 2.0%; odds ratio, 1.3; 95% CI, 0.9-1.9; interaction P=0.006). In patients treated with CAS, age increased the risk for both immediate and delayed events while qualifying event severity only increased the risk of delayed events. In patients treated with CEA, we found no risk factors for immediate events while a higher level of disability at baseline and known history of hypertension were associated with delayed procedural events. Conclusions- The increased procedural stroke or death risk associated with CAS compared with CEA was caused by an excess of events occurring on the day of procedure. This finding demonstrates the need to enhance the procedural safety of CAS by technical improvements of the procedure and increased operator skill. Higher age increased the risk for both immediate and delayed procedural events in CAS, mechanisms of which remain to be elucidated. Clinical Trial Registration- URL: https://clinicaltrials.gov . Unique identifier: NCT00190398. URL: http://www.isrctn.com . Unique identifier: ISRCTN57874028. URL: http://www.isrctn.com . Unique identifier: ISRCTN25337470. URL: https://clinicaltrials.gov . Unique identifier: NCT00004732.
| S-EPMC6209445 | biostudies-literature
Project description:BACKGROUND:Rheumatoid arthritis (RA) is a chronic inflammatory arthritis, with significant impact on quality of life and functional status. Whilst biologic disease modifying anti-rheumatic drugs (bDMARD) such as tumour necrosis factor-inhibitor (TNFi) agents have revolutionised outcomes in RA, early diagnosis with immediate conventional therapy, titrated in a treat to target approach is also associated with high remission rates. The main aim of the VEDERA study (Very Early versus Delayed Etanercept in Rheumatoid Arthritis) is to assess the depth of remission, sustainability of remission and immunological normalisation induced by very early TNFi with etanercept (ETN) or standard of care +/- delayed ETN. METHODS/DESIGN:VEDERA is a pragmatic, phase IV single-centre open-label randomised superiority trial of 120 patients with early, treatment-naive RA. Patients will be randomised 1:1 to first-line ETN and methotrexate (MTX) or MTX with additional synthetic disease modifying anti-rheumatic drugs (sDMARDs) according to a treat to target (TT) protocol with further step up to ETN and MTX after 24 weeks if remission is not achieved. Participants will have regular disease activity assessments and imaging evaluation including musculoskeletal ultrasound and MRI. The main objective of this study is to assess the proportion of patients with early RA that achieve clinical remission at 48 weeks, following either treatment strategy. In addition, the participants are invited to take part in a cardio-vascular sub-study (Coronary Artery Disease in RA, CADERA), which aims to identify the incidence of cardiovascular abnormalities in early RA. DISCUSSION:The hypothesis underlining this study is that very early treatment with first-line ETN increases the proportion of patients with rheumatoid arthritis achieving clinical remission, in comparison to conventional therapy. TRIAL REGISTRATION:NCT02433184 , 23/04/2015.
| S-EPMC4743173 | biostudies-literature