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Journal of Neuro-Oncology - Cognitive impairment is frequent in patients with high-grade glioma and requires cognitive follow-up. Cognitive screening tools such as the Montreal Cognitive Assessment...  相似文献   
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ObjectivesWe investigated psycho-physiological responses to perceptually regulated interval walks in hypoxia versus normoxia in obese individuals.DesignWithin-participants repeated measures.MethodsTen obese adults (BMI = 32 ± 3 kg/m?2) completed a 60-min interval session (15 × 2 min walking at a rating of perceived exertion of 14 on the 6–20 Borg scale with 2 min of rest) either in hypoxia (FiO2 = 13.0%, HYP) or normoxia (NOR). A third trial replicating the HYP speed pattern was carried out in normoxia as a control (CON). Exercise responses were analysed comparing the average of 1st to 3rd exercise bouts to those of the 4th–6th, 7th–9th, 10th–12th and 13th–15th exercise bouts (block 1 versus 2, 3, 4 and 5).ResultsTreadmill speed was slower during block 4 (6.14 ± 0.67 versus 6.24 ± 0.73 km/h?1) and block 5 (6.12 ± 0.64 versus 6.25 ± 0.75 km/h?1) in HYP compared to NOR or CON (p = 0.009). Compared to NOR and CON, heart rate was +6–10% higher (p = 0.001), whilst arterial oxygen saturation (?12–13%) was lower (p < 0.001) in HYP. Perceived limb discomfort was lower in HYP and CON versus NOR (?21 ± 4% and ?34 ± 6%; p = 0.004).ConclusionsIn overweight-to-obese adults, perceptually regulated interval walks in hypoxia versus normoxia leads to progressively slower speeds along with lower limb discomfort and larger physiological stress than normoxia. Walking at the speed adopted in hypoxia produces similar psycho-physiological responses at the same absolute intensity in normoxia.  相似文献   
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Background Context

Postoperative morbidity may offset the potential benefits of surgical treatment for spine metastatic disease; hence, risk factors for postoperative complications and reoperations should be taken into considerations during surgical decision-making. In addition, it remains unknown whether complications and reoperations shorten these patients' survival.

Purpose

We aimed to describe and identify factors associated with having a complication within 30 days of index surgery as well as factors associated with having a subsequent reoperation. Furthermore, we assessed the effect of 30-day complications and reoperations on the patients' postoperative survival, as well as described neurologic changes after surgery.

Study Design

Retrospective cohort study.

Patient Sample

We included 647 patients 18 years and older who had surgery for metastatic disease in the spine between January 2002 and January 2014 in one of two affiliated tertiary care centers.

Outcome Measures

Our primary outcomes were complications within 30 days after surgery and reoperations until final follow-up or death.

Methods

We used multivariate logistic regression to identify risk factors for 30-day complications and reoperations. We used the Cox regression analysis to assess the effect of postoperative complications and reoperations on survival.

Results

From 647 included patients, 205 (32%) had a complication within 30 days. The following variables were independently associated with 30-day complications: lower albumin levels (odds ratio [OR]: 0.69, 95% confidence interval [CI]=0.49–0.96, p=.021), additional comorbidities (OR=1.42, 95% CI=1.00–2.01, p=.048), pathologic fracture (OR=1.41, 95% CI=0.97–2.05, p=.031), three or more spine levels operated upon (OR=1.64, 95% CI=1.02–2.64, p=.027), and combined surgical approach (OR=2.44, 95% CI=1.06–5.60, p=.036). One hundred and fifteen patients (18%) had at least one reoperation after the initial surgery; prior radiotherapy (OR=1.56, 95% CI=1.07–2.29, p=.021) to the spinal tumor was independently associated with reoperation. 30-day complications were associated with worse survival (hazard ratio [HR]=1.40, 95% CI=1.17–1.68, p<.001), and reoperation was not significantly associated with worse survival (HR=0.80, 95% CI=0.09–1.00, p=.054). Neurologic status worsened in 42 (6.7%), remained stable in 445 (71%), and improved in 140 (22%) patients after surgery.

Conclusions

Three or more spine levels operated upon and prior radiotherapy should prompt consideration of a preoperative plastic surgery consultation regarding soft tissue coverage. Furthermore, if time allows, aggressive nutritional supplementation should be considered for patient with low preoperative serum albumin levels. Surgeons should be aware of the increase in complications in patients presenting with pathologic fracture, undergoing a combined approach, and with any additional preoperative comorbidities. Importantly, 30-day complications were associated with worsened survival.  相似文献   
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After 4 years of early benefit assessment (EBA) in Germany, it is becoming evident that the Federal Joint Committee (FJC) frequently considers well-established clinical endpoints as not being relevant to patients. Focusing on assessments of oncology medicines, we analysed the FJC’s view on primary endpoints and compared it with the approach used by regulatory authorities. Mortality data were accepted by both stakeholders. Whereas regulatory authorities accepted primary morbidity endpoints such as progression-free survival and response rates, the FJC mostly excluded these from its assessments. Health-related quality of life (HRQoL) data have been poorly reflected in the approval process; for EBAs, those data have rarely impacted on benefit ratings. We argue that agreement between regulatory authorities and the FJC is required regarding primary study endpoints that are relevant to patients, and that clarification of acceptable endpoints by the FJC, especially in the morbidity domain, has to be provided. Moreover, in order to fully acknowledge the benefit of a new medicinal product, mortality, morbidity and HRQoL should be weighted differentially, according to the condition.  相似文献   
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