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.
Project description:BackgroundTiming of surgery remains controversial in patients with infective endocarditis and stroke. Guidelines on infective endocarditis suggest delaying surgery for up to 4 weeks. However, with early heart failure due to progression of the infection or recurrent septic embolism, urgent surgery becomes imperative.MethodsOut of 688 patients who were surgically treated for left-sided infective endocarditis, 187 presented with preoperative neurological events. The date of cerebral stroke onset was documented in 147 patients. The patients were stratified according to timing of surgery: 61 in the early group (0-7 days) vs. 86 in the delayed group (>7 days). Postoperative neurological outcome was assessed by the modified Rankin Scale.ResultsPreoperative sepsis was more prevalent in patients with preoperative neurological complications (46.0% vs. 29.5%, p < 0.001). Patients with haemorrhagic stroke were operated on later (19.8% vs. 3.3%, p = 0.003). Postoperative cerebrovascular accidents were comparable between both groups (p = 0.13). Overall, we observed good neurological outcomes (p = 0.80) and a high recovery rate, with only 5% of cases showing neurological deterioration after surgery (p = 0.29). In-hospital mortality and long-term survival were not significantly different in the early and delayed surgery groups (log-rank, p = 0.22).ConclusionsEarly valve surgery in high-risk patients with infective endocarditis and stroke can be performed safely and is not associated with worse outcomes.
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.
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.
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.
Project description:ObjectiveTo examine the ability to perform basic and instrumental activities of daily life after very early supported discharge vs usual discharge and referral routine during the first year after mild stroke.DesignA secondary analysis of data from the Gothenburg Very Early Supported Discharge randomized controlled trial. Patients: A total of 104 patients (56% men; mean (standard deviation) age 75 (11) years) who had experienced a first stroke classified as mild.MethodsThe primary outcome was the Activities of Daily Living Taxonomy score. Stroke Impact Scale (activities of daily living, and mobility) scores was a secondary measure. Patients were randomized to either very early supported discharge with 4 weeks of home rehabilitation provided by a multidisciplinary stroke team, or a control group discharged according to usual routine (referral to primary care when needed). Assessments were performed at discharge, 4 weeks post-discharge, and 3 and 12 months post-stroke.ResultsInstrumental activities of the Activities of Daily Living Taxonomy scores (the lower the better) in the very early supported discharge and control groups were median 4 and 6 (p = 0.039) at 4 weeks post-discharge and 3 and 4.5 (p = 0.013 at 3 months post-stroke, respectively. Stroke Impact Scale (Mobility) median scores (the higher the better) in the very early supported discharge and control groups at 3 months were 97 and 86 (p = 0.040), respectively. There were no group differences in the 2 outcomes at 12 months post-stroke.ConclusionCompared with usual discharge routine, team-based rehabilitation during the first month at home is beneficial for instrumental activity in the subacute phase, in patients with mild stroke. One year post-stroke both groups show equal results.
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.
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.