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This study investigated the association between post-stroke fatigue and inability to return to work/drive in young patients aged <60 years with first stroke who were employed prior to infarct while controlling for stroke severity, age, extent of disability, cognitive function, and depression. The Fatigue Severity Scale (FSS) was used to evaluate post-stroke fatigue in this 1-year prospective cohort study. Follow-ups were completed at 3, 6, and 12 months post rehabilitation discharge. A total of 112 patients were recruited, 7 were excluded, due to loss to follow-up (n = 6) and being palliative (n = 1), resulting in 105 participants (71% male, average age 49 ±10.63 years). Stroke patients receiving both inpatient and outpatient rehabilitation were consecutively recruited. Persistent fatigue remained associated with inability to return to work when controlling for other factors at 3 months (adjusted OR = 18, 95% CI: 2.9, 110.3, p = 0.002), 6 months (adjusted OR = 29.81, 95% CI: 1.7, 532.8, p = 0.021), and 12 months (adjusted OR = 31.6, 95% CI: 1.8, 545.0, p = 0.018). No association was found between persistent fatigue and return to driving. Fatigue at admission was associated with inability to return to work at 3 months but not return to drive. Persistent fatigue was found to be associated with inability to resume work but not driving. It may be beneficial to routinely screen post-stroke fatigue in rehabilitation and educate stroke survivors and employers on the impacts of post-stroke fatigue on return to work.

AbstractObjectivesTo determine the rate of a first recurrent venous thromboembolism (VTE) event after discontinuation of anticoagulant treatment in patients with a first episode of unprovoked VTE, and the cumulative incidence for recurrent VTE up to 10 years.DesignSystematic review and meta-analysis.Data sourcesMedline, Embase, and the Cochrane Central Register of Controlled Trials (from inception to 15 March 2019).Study selectionRandomised controlled trials and prospective cohort studies reporting symptomatic recurrent VTE after discontinuation of anticoagulant treatment in patients with a first unprovoked VTE event who had completed at least three months of treatment.Data extraction and synthesisTwo investigators independently screened studies, extracted data, and appraised risk of bias. Data clarifications were sought from authors of eligible studies. Recurrent VTE events and person years of follow-up after discontinuation of anticoagulant treatment were used to calculate rates for individual studies, and data were pooled using random effects meta-analysis. Sex and site of initial VTE were investigated as potential sources of between study heterogeneity.Results18 studies involving 7515 patients were included in the analysis. The pooled rate of recurrent VTE per 100 person years after discontinuation of anticoagulant treatment was 10.3 events (95% confidence interval 8.6 to 12.1) in the first year, 6.3 (5.1 to 7.7) in the second year, 3.8 events/year (95% confidence interval 3.2 to 4.5) in years 3-5, and 3.1 events/year (1.7 to 4.9) in years 6-10. The cumulative incidence for recurrent VTE was 16% (95% confidence interval 13% to 19%) at 2 years, 25% (21% to 29%) at 5 years, and 36% (28% to 45%) at 10 years. The pooled rate of recurrent VTE per 100 person years in the first year was 11.9 events (9.6 to 14.4) for men and 8.9 events (6.8 to 11.3) for women, with a cumulative incidence for recurrent VTE of 41% (28% to 56%) and 29% (20% to 38%), respectively, at 10 years. Compared to patients with isolated pulmonary embolism, the rate of recurrent VTE was higher in patients with proximal deep vein thrombosis (rate ratio 1.4, 95% confidence interval 1.1 to 1.7) and in patients with pulmonary embolism plus deep vein thrombosis (1.5, 1.1 to 1.9). In patients with distal deep vein thrombosis, the pooled rate of recurrent VTE per 100 person years was 1.9 events (95% confidence interval 0.5 to 4.3) in the first year after anticoagulation had stopped. The case fatality rate for recurrent VTE was 4% (95% confidence interval 2% to 6%).ConclusionsIn patients with a first episode of unprovoked VTE who completed at least three months of anticoagulant treatment, the risk of recurrent VTE was 10% in the first year after treatment, 16% at two years, 25% at five years, and 36% at 10 years, with 4% of recurrent VTE events resulting in death. These estimates should inform clinical practice guidelines, enhance confidence in counselling patients of their prognosis, and help guide decision making about long term management of unprovoked VTE.Systematic review registrationPROSPERO CRD42017056309.

Delayed entry of blood culture bottles is frequent in consolidated laboratories. A retrospective study evaluated time from insertion to detection and total detection time as a function of preincubation time, and we prospectively looked for false negative results. 69,604 blood culture bottles were reviewed for preincubation time, incubation time and total detection time. Positive cultures for specific bacterial subtypes were reviewed to assess the effect of preincubation time on likelihood of detection. 492 negative blood cultures were prospectively tested by 16S RNA PCR and Staphylococcus -specific PCR for the presence of bacterial DNA. Mean preincubation time for samples collected within the city-limits was 3.94 h versus 9.49–18.89 h for other client sites. Higher preincubation times were partially mitigated by a lower incubation time, with an overall increase in total detection time. A lower odds ratio of recovery of Staphylococcus spp was identified, but not confirmed by terminal subcultures and molecular assays. Prolonged preincubation of blood cultures affects total detection time despite a reduction in incubation time. Successful centralization of microbiological services may depend upon optimization of courier routes for inoculated blood culture bottles. Our data supports consideration for an increase in suggested maximum preincubation times.

In a trial involving more than 2400 critically ill patients, 90-day mortality was similar among patients receiving blood donated on average 6 days earlier and those receiving blood donated 22 days earlier. The age of the transfused blood did not influence outcomes. Blood transfusions are administered frequently and may have unintended consequences in critically ill patients. 1 – 4 Current regulations permit the storage of red cells for up to 42 days, but prolonged storage has been associated with changes that may render red cells ineffective as oxygen carriers and that lead to the accumulation of substances that have untoward biologic effects. 5 – 8 A systematic review of 18 observational studies involving a total of 409,840 patients and three randomized, controlled trials involving a total of 126 patients suggested that the transfusion of older red cells, as compared with newer red cells, was associated with . . .

Soy and red clover isoflavones are controversial due to purported estrogenic activity and possible effects on breast cancer. We conducted a systematic review of soy and red clover for efficacy in improving menopausal symptoms in women with breast cancer, and for potential impact on risk of breast cancer incidence or recurrence. We searched MEDLINE, Embase, the Cochrane Library, and AMED from inception to March 2013 for human interventional or observational data pertaining to the safety and efficacy of soy and red clover isoflavones in patients with or at risk of breast cancer. Of 4179 records, we included a total of 131 articles: 40 RCTs, 11 uncontrolled trials, and 80 observational studies. Five RCTs reported on the efficacy of soy for hot flashes, showing no significant reductions in hot flashes compared to placebo. There is lack of evidence showing harm from use of soy with respect to risk of breast cancer or recurrence, based on long term observational data. Soy intake consistent with that of a traditional Japanese diet (2-3 servings daily, containing 25-50mg isoflavones) may be protective against breast cancer and recurrence. Human trials show that soy does not increase circulating estradiol or affect estrogen-responsive target tissues. Prospective data of soy use in women taking tamoxifen does not indicate increased risk of recurrence. Evidence on red clover is limited, however existing studies suggest that it may not possess breast cancer-promoting effects. Soy consumption may be associated with reduced risk of breast cancer incidence, recurrence, and mortality. Soy does not have estrogenic effects in humans. Soy intake consistent with a traditional Japanese diet appears safe for breast cancer survivors. While there is no clear evidence of harm, better evidence confirming safety is required before use of high dose (≥ 100 mg) isoflavones can be recommended for breast cancer patients.

BackgroundComplex perianal fistulas occurring in the absence of luminal inflammation (isolated perianal disease, IPD) may represent a specific phenotype of Crohn’s disease (CD).AimWe assessed the effectiveness of tumor necrosis factor (TNF)-antagonists in patients with IPD compared to those with perianal CD (PCD) with luminal inflammation.MethodsPatients were identified through our institutional radiology database and were classified as PCD or IPD based on the presence or absence of luminal inflammation by ileocolonoscopy and abdominal enterography. Consecutive adults (> 17 years) with recurrent IPD who were treated with TNF antagonists were matched by age and gender to patients with complex PCD (1:2 ratio). Fistula remission was defined as an absence of fistula drainage. Surgery-free survival was assessed by Cox proportional hazard models.ResultsTwenty-two patients with IPD treated with a TNF antagonist were compared with 44 matched patients with PCD. A similar proportion of patients with IPD and PCD were treated with concomitant immunomodulators (55% vs. 66%) and underwent examinations under anesthesia prior to therapy (36% vs. 46%). Fistula remission at 3, 6, and 12 months was lower for the IPD cohort: 9.5% versus 34%; 19% versus 39%; and 19% versus 43%. Surgical intervention after initiating anti-TNF therapy was more common for patients with IPD (HR 3.99: 95% CI, 1.62–9.83; p = 0.0026).ConclusionsFewer patients with IPD achieved fistula remission, and more required surgical intervention after anti-TNF therapy, suggesting that TNF antagonists may not be as effective in these patients.

Background: Biomechanical studies have shown that the transosseous equivalent suture bridge (TOE-SB) rotator cuff repair technique improves contact areas and pressure between the tendon and footprint, which may facilitate healing. However, few studies have directly compared its outcomes with traditional double-row (DR) repair. Purpose/Hypothesis: The primary objectives of this study were to (1) compare the functional outcomes of DR with TOE-SB fixation in patients undergoing arthroscopic rotator cuff repairs and (2) compare healing rates between the 2 groups and investigate whether any factors were associated with healing. It was hypothesized that arthroscopic rotator cuff repair using DR repair would demonstrate no difference in disease-specific quality of life, patient-reported outcomes, or healing rates compared with TOE-SB repair. Study Design: Cohort study; Level of evidence, 3. Methods: This was a cohort study conducted as a subanalysis of 2 larger randomized controlled trials. Patients ≥18 years old with degenerative rotator cuff tears confirmed by magnetic resonance imaging who had persistent symptoms of pain and functional impairment after 6 months of nonoperative management were enrolled in prospective randomized controlled trials and underwent either a traditional DR repair or a TOE-SB rotator cuff repair. Functional outcomes were assessed using the Western Ontario Rotator Cuff index, the American Shoulder and Elbow Surgeons score, and the Constant score at baseline and 3, 6, 12, and 24 months postoperatively. Healing rates were determined using ultrasound at 24 months postoperatively. Results: A total of 184 patients were included in this study; 34 patients underwent conventional DR repair and 150 underwent TOE-SB repair. Postoperative changes in the outcome measures from baseline were statistically significant for all outcomes in both groups (P < .0001). No statistically significant differences were found between outcomes at any of the follow-up times, except a significant difference in the Constant score at 24 months in favor of the DR group (mean ± SE, 80.5 ± 1.1 [95% CI, 78.4-82.7]) and TOE-SB and DR, respectively (mean ± SE, 85.7 ± 2.2 [95% CI, 81.2-90.1]) (P = .041). Healing rates were 77.8% for DR and 83% for TOE-SB (odds ratio, 1.34 [95% CI, 0.53-3.38]; P = .53). Multivariable regression analysis showed a positive correlation between nonhealing rates and the rotator cuff tear size in the sagittal plane (odds ratio, 1.97 (95% CI, 1.02-3.78); P = .042). Conclusion: No difference was found between DR and TOE-SB rotator cuff repair in the Western Ontario Rotator Cuff index, the American Shoulder and Elbow Surgeons score, Constant strength subscore, or the healing rate. The Constant score at the 24-month follow-up favored DR repair but did not reach the minimal clinically important difference. An association was found between higher healing rates and smaller sagittal plane tear sizes.

PurposeThere is controversy whether teratospermia is associated with poorer IVF outcomes and if ICSI may overcome this deficit. The debate likely lies in study heterogeneity, poor adjustment for confounders, and inter-observer variation in sperm morphology assessment. Given the current literature, a shift in practice was implemented at our center in February 2017, whereby teratospermia was no longer a criterion for ICSI. We hypothesized that, despite decreasing ICSI rates, we would see no change in ART outcomes.MethodsA retrospective study was performed including 1821 couples undergoing IVF/ICSI at a single center from January 2016 to December 2018, divided into cohorts before and after the practice change. The primary outcome of clinical pregnancy and secondary outcomes of fertilization, fertilization failure, good quality blastocyst formation, embryo utilization, positive hCG, and miscarriage rates was compared, adjusting for potential confounders. Subgroup analysis was performed evaluating teratospermia as the only reason for a male factor infertility diagnosis.ResultsDespite a decrease in ICSI rate of 30.3%, we found no significant difference in clinical intrauterine pregnancy rate, with an adjusted relative risk of 0.93 (0.81, 1.07, P = 0.3008). There were no significant differences in other secondary outcomes after multivariate adjustment. Subgroup analysis for those with male factor infertility due to teratospermia showed no difference in outcomes.ConclusionThis study concurs with the recent data suggesting that employing ICSI solely for teratospermia is unnecessary. This may allow clinics to decrease ICSI rates without sacrificing success rates, leading to lower cost and risk associated with treatment.

BACKGROUND: Uncontrolled cancer pain (CP) may impair quality of life. Given the multidimensional nature of CP, its poor control is often attributed to poor assessment and classification. OBJECTIVES: To determine the characteristics and associations of pain intensity in a specialist CP clinic. METHODS: Consecutive patients referred to the CP clinic of the Portuguese Cancer Institute (Lisbon, Portugal) had standardized initial assessments and status documentation of the following: Brief Pain Inventory ratings for ‘pain now’ as the outcome variable; initial pain intensity (iPI) on a 0 to 10 scale; pain mechanism (using the Douleur Neuropathique 4 tool to assess neuropathic pain); episodic pain; Eastern Cooperative Oncology Group rating; oral morphine equivalent daily dose (MEDD); Hospital Anxiety Depression Scale and Emotional Thermometer scores; and cancer diagnosis, metastases, treatment and pain duration. Univariable analyses were conducted to test the association of independent variables with iPI. Variables with P<0.1 were entered into a multivariable regression model, using backward elimination and a cut‐point of P=0.2 for final model selection. RESULTS: Of 371 participants, 285 (77%) had moderate (4 to 6) or severe (7 to 10) iPI. The initial median MEDD was relatively low (30 mg [range 20 mg to 60 mg]). In the multivariable model, higher income, Eastern Cooperative Oncology Group rating 3 to 4, cancer diagnosis (head and neck, genitourinary and gastrointestinal), adjuvant use and initial MEDD were associated with iPI (P<0.05). The model’s R 2 was 18.6, which explained only 19% of iPI variance. CONCLUSIONS: The diversity of factors associated with pain intensity and their limited explanation of its variance underscore the biopsychosocial complexity of CP. Adequacy of CP management warrants further exploration.

IntroductionFor patients with a first unprovoked venous thromboembolism (VTE), the optimal duration of anticoagulation is a crucial clinical dilemma which has yet to be resolved. The decision to stop anticoagulant therapy (AT) after the initial 3–6 months or to continue AT indefinitely, is primarily governed by the long-term risk of recurrence when treatment is discontinued. This risk however, is not well established, hindering decision making.Methods and analysisWe will conduct a systematic review and a meta-analysis of studies involving patients diagnosed with a first, symptomatic unprovoked VTE or VTE provoked by minor transient risk factors, who have completed at least 3 months of initial AT; and who were followed-up for standardised time intervals of 1, 2, 5, 10 and 20 years (±3 months) after stopping AT. We will search (from inception to January 2017) MEDLINE, Embase and the Cochrane library for randomised controlled trials and prospective observational studies. Two reviewers will conduct all screening and data collection independently. The primary outcome of the rate of recurrent VTE at the standardised time intervals will be calculated for each study from the total number of recurrent events and the corresponding number of patient-years of follow-up. We will use a random-effects model to pool study results and report a weighted estimate of the absolute rate of recurrent VTE (events per 100 patient-years) over standardised time intervals of 1, 2, 5, 10 and 20 years after discontinuing anticoagulants.Ethics and disseminationEthical approval is not applicable for this study. Findings from this study will be disseminated through peer-reviewed journal publication as well as relevant national and international conference presentations.PROSPERO registration numberCRD42017056309.