A post-hoc analysis of music therapy services for residents in nursing homes receiving hospice care

This study analyzed the use of music therapy for residents in nursing homes receiving hospice care. An ex-post facto design was utilized to evaluate participants' length of life on the hospice program, time of death in relation to last visit by the social worker and music therapist, the number of sessions and total number of minutes spent in direct care by the social worker and music therapist, and care plan needs treated by the nurse, social worker, and music therapist. A total of 80 participants' medical records were randomly selected for this study. All participants were in nursing homes, 40 of whom had been referred to music therapy. Results showed no significant differences on the time of death in relation to last visit by hospice professional, but there were significant differences in the length of life for those receiving music therapy. Females in this study lived significantly longer than males. Participants received significantly more music therapy sessions than social work sessions, and music therapists spent significantly more time in direct care with participants than did social workers. Care plan needs were analyzed graphically and indicate that music therapists meet important needs of participants.     

Statin effect on thrombin inhibitor effectiveness during percutaneous coronary intervention: a post-hoc analysis from the ISAR-REACT 3 trial

Objective

To determine whether statin therapy influences the efficacy of thrombin inhibitor bivalirudin or unfractionated heparin (UFH) during PCI.

Setting and patients

The post-hoc analysis of the ISAR-REACT 3 Trial included 4,570 patients: 3,106 patients were on statin therapy and 1,464 patients were not on statin therapy at the time of PCI procedure.

Main outcome measures

The primary outcome of this analysis was the 30-day composite of death, myocardial infarction, target vessel revascularization (TVR) or major bleeding.

Results

The primary outcome occurred in 7.9% patients (n?=?246) in the statin group versus 9.8% (n?=?143) in the non-statin group (P?=?0.036). There was an interaction in univariate (P?=?0.028) and multivariable (P?=?0.026) analysis between pre-PCI statin therapy and the type of antithrombotic therapy regarding myocardial infarction. In the statin group, bivalirudin significantly reduced the incidence of major bleeding (2.6 vs. 4.3%, P?=?0.013) with no significant difference in the incidence of myocardial infarction (4.9 vs. 5.2%; P?=?0.73) compared with UFH. In the non-statin group, bivalirudin was inferior to UFH regarding the incidence of myocardial infarction (7.1 vs. 4.1%, P?=?0.013), yet major bleeding remained lower among bivalirudin-treated patients (4.0 vs. 5.2%, P?=?0.25).

Conclusion

This post-hoc analysis suggests the existence of an interaction between statin therapy before PCI and antithrombotic therapy during PCI. Patients receiving bivalirudin therapy at the time of PCI showed less periprocedural myocardial infarction when on pre-PCI statin therapy which has to be investigated in further studies.     

Gender differences in mortality and quality of life after septic shock: A post-hoc analysis of the ARISE study

PurposeTo assess the impact of gender and pre-menopausal state on short- and long-term outcomes in patients with septic shock.Material and methodsCohort study of the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial, an international randomized controlled trial comparing early goal-directed therapy (EGDT) to usual care in patients with early septic shock, conducted between October 2008 and April 2014. The primary exposure in this analysis was legal gender and the secondary exposure was pre-menopausal state defined by chronological age (≤ 50 years).Results641 (40.3%) of all 1591 ARISE trial participants in the intention-to-treat population were females and overall, 337 (21.2%) (146 females) patients were 50 years of age or younger. After risk-adjustment, we could not identify any survival benefit for female patients at day 90 in the younger (≤50 years) (adjusted Odds Ratio (aOR): 0.91 (0.46–1.89), p = .85) nor in the older (>50 years) age-group (aOR: 1.10 (0.81–1.49), p = .56). Similarly, there was no gender-difference in ICU, hospital, 1-year mortality nor quality of life measures.ConclusionsThis post-hoc analysis of a large multi-center trial in early septic shock has shown no short- or long-term survival effect for women overall as well as in the pre-menopausal age-group.     

Comparison of two frailty identification tools for critically ill patients: A post-hoc analysis of a multicenter prospective cohort study

PurposeWe aimed to describe the association of two frailty screening tools, the validated Clinical Frailty Scale (CFS) score and the recently described modified Frailty Index (mFI) in critically ill patients.Materials and methodsWe performed a post-hoc analysis of a multicenter cohort of patients admitted to six Canadian Intensive Care Units (ICU) between 2010 and 2011. Frailty was screened using the CFS and the mFI. Concordance between these tools was evaluated, as well as discrimination and predictive ability for clinical outcomes after adjustments.ResultsThe cohort included 421 patients. Prevalence of frailty was 32.8% with the CFS and 39.2% with the mFI. However, concordance between the two tools was low [(intraclass correlation of 0.37; 95% confidence interval [CI] 0.29–0.45) and partial Spearman rank correlation of 0.38 (95% CI 0.29–0.47)]. Hospital and 1-year mortality, as well as dependency after discharge and hospital readmission, were greater for frail compared to non-frail patients screened with the use of both tools.ConclusionWhile the CFS and mFI showed low concordance, both showed good discrimination and predictive validity for hospital mortality. Both tools identify a subgroup of frail patients more likely to have worse clinical outcomes.     

Hepatic dysfunction impairs prognosis in critically ill patients with hematological malignancies: A post-hoc analysis of a prospective multicenter multinational dataset

PurposeHyperbilirubinemia is frequent in patients with hematological malignancies admitted to the intensive care unit (ICU). Literature about hepatic dysfunction (HD) in this context is scarce.MethodsWe investigated the prognostic impact of HD analyzing a prospective multicenter cohort of 893 critically ill hematology patients. Two groups were defined: patients with HD (total bilirubin ≥33 μmol/L at ICU admission) and patients without HD.ResultsTwenty one percent of patients were found to have HD at ICU admission. Cyclosporine, antimicrobials before ICU admission, abdominal symptoms, ascites, history of liver disease, neutropenia, increased serum creatinine and myeloma were independently associated with HD. Etiology remained undetermined in 73% of patients. Hospital mortality was 56.3% and 36.3% respectively in patients with and without HD (p < 0.0001). Prognostic factors independently associated with hospital mortality in HD group were, performance status >1 (OR = 2.07, 95% CI = 1.49–2.87, p < 0.0001), invasive mechanical ventilation (OR = 3.92, 95% CI = 2.69–5.71, p < 0.0001), renal replacement therapy (OR = 1.74, 95% CI = 1.22–2.47, p = 0.002), vasoactive drug (OR = 1.81, 95% CI = 1.21–2.71, p = 0.004) and SOFA score without bilirubin level at ICU admission (OR = 1.09, 95% CI = 1.04–1.14, p < 0.0001).ConclusionsHD is common, underestimated, infrequently investigated, and is associated with impaired outcome in critically ill hematology patients. HD should be considered upon ICU admission and managed as other organ dysfunctions.     

Improvement of gastrointestinal health status in subjects consuming Lactobacillus reuteri NCIMB 30242 capsules: a post-hoc analysis of a randomized controlled trial

Objective: Gastrointestinal (GI) symptoms are conditions that are frequently observed in clinical practice. A post-hoc analysis has been undertaken to evaluate the effect of bile salt hydrolase-active L. reuteri NCIMB 30242 on GI health status based on Rome III questionnaire response in otherwise healthy hypercholesterolemic subjects.

Research design/Methods: A total of 127 subjects received either L. reuteri NCIMB 30242 or placebo capsules over a 9-week intervention in a randomized, double-blind, placebo-controlled, parallel-arm, multicenter study. Subjects were asked to complete the Rome III diagnostic GI questionnaire prior to the baseline and end point visits of the clinical study.

Main outcome measure: GI health status was evaluated, per questionnaire, by assessing all questions with 5- or 7-point response scales for symptoms of the stomach and intestines.

Results: Subjects receiving L. reuteri NCIMB 30242 reported significant improvements in general GI health status (p = 0.029) and in symptoms related to diarrhea (p = 0.018) as compared to placebo over the intervention period. Further, a greater proportion of L. reuteri-treated subjects showed improved general GI health status (p = 0.042) and improved diarrhea symptoms (p = 0.03).

Conclusions: L. reuteri NCIMB 30242 capsules appear to be well tolerated and potentially beneficial for GI health status. Further clinical investigation is warranted for the treatment of functional GI disorders.     

1例Bx亚型的分子机制研究

目的探讨＆亚型的分子机制。方法采用标准方法分析＆亚型的血清学特性,并使用PCR产物直接测序或克隆后测序ABO基因7个外显子和外显子与内含子交界区。结果确认1例Bx表型,DNA分析显示该＆个体的ABO基因为杂合001／g基因：905A〉G导致B糖基转移酶中氨基酸D302G改变。结论在中国汉族人群中检测到Bx02等位基因。     

Effects of curcumin on serum cytokine concentrations in subjects with metabolic syndrome: A post-hoc analysis of a randomized controlled trial

BackgroundCytokines are involved in the development of metabolic abnormalities that may result in metabolic syndrome (MetS). Since curcumin has shown anti-inflammatory properties, the aim of this study was to evaluate the effect of curcumin supplementation on serum cytokines concentrations in subjects with MetS.MethodsThis study was a post-hoc analysis of a randomized controlled trial in which males and females with diagnosis of MetS, according to the criteria defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines, were studied. Subjects who met the inclusion criteria were randomly assigned to either curcumin (daily dose of 1 g/day) or a matched placebo for a period of 8 weeks.ResultsOne hundred and seventeen subjects were assigned to either curcumin (n = 59) or placebo (n = 58) groups. Within-group analysis revealed significant reductions in serum concentrations of TNF-α, IL-6, TGF-β and MCP-1 following curcumin supplementation (p < 0.001). In the placebo group, serum levels of TGF-β were decreased (p = 0.003) but those of IL-6 (p = 0.735), TNF-α (p = 0.138) and MCP-1 (p = 0.832) remained unaltered by the end of study. Between-group comparison suggested significantly greater reductions in serum concentrations of TNF-α, IL-6, TGF-β and MCP-1 in the curcumin versus placebo group (p < 0.001). Apart from IL-6, changes in other parameters remained statistically significant after adjustment for potential confounders including changes in serum lipids and glucose levels, and baseline serum concentration of the cytokines.ConclusionResults of the present study suggest that curcumin supplementation significantly decreases serum concentrations of pro-inflammatory cytokines in subjects with MetS.     

正常兔与骨性关节炎兔关节液的分析

背景:研究表明,在骨关节炎关节液中,关节液的成分发生了改变,与软骨损伤密切相关.目的:测定骨性关节炎兔和正常兔关节液离子、细胞数及透明质酸水平,观察早期骨性关节炎关节液理化环境的变化并与关节软骨病理改变之间的关系;观察骨性关节炎中自细胞介素1、肿瘤坏死因子a在早期骨性关节炎中的变化及其意义.方法:新西兰大白兔采用Hulth方法制备右膝关节骨性关节炎模型,左膝关节正常对照.分别在第4,6,8周双膝取材.进行病理切片观察和关节液常规生化定量,并采用ELISA方法对关节液中的透明质酸、白细胞介素1、肿瘤坏死因子α进行定量检测.结果与结论:在早期骨性关节炎兔关节液中,离子浓度变化不大;透明质酸、白细胞介素1、肿瘤坏死因子a水平在第4周即发生变化:透明质酸水平在造模后4周明显升高,随软骨病变程度增加而下降趋势明显,至造模后8周时浓度已下降至正常水平;白细胞介素1水平在造模后4周明显升高,4,6,8周水平有波动,总体水平高表达;肿瘤坏死因子a水平在造模后4周明显升高,4,6,8周水平逐渐上升.     

Crenobalneotherapy (spa therapy) in patients with knee and generalized osteoarthritis: A post-hoc subgroup analysis of a large multicentre randomized trial

ObjectiveTo determine whether the addition of spa therapy to home exercises provides any benefit over exercises and the usual treatment alone in the management of generalised osteoarthritis associated with knee osteoarthritis.MethodsThis study was a post-hoc subgroup analysis of our randomised multicentre trial (www.clinicaltrial.gov: NCT00348777). Participants who met the inclusion criteria of generalized osteoarthritis (Kellgren, American College of Rheumatology, or Dougados criteria) were extracted from the original randomised controlled trial. They had been randomised using Zelen randomisation. The treatment group received 18 days of spa treatment in addition to a home exercise programme. Main outcome was number of patients achieving minimal clinically important improvement at six months (MCII) (≥ −19.9 mm on the VAS pain scale and/or ≥ −9.1 points in a WOMAC function subscale), and no knee surgery. Secondary outcomes included the “patient acceptable symptom state” (PASS) defined as VAS pain ≤ 32.3 mm and/or WOMAC function subscale ≤ 31 points.ResultsFrom the original 462 participants, 214 patients could be categorized as having generalised osteoarthritis. At sixth month, 182 (88 in control and 94 in SA group) patients, were analysed for the main criteria. MCII was observed more often in the spa group (n = 52/94 vs. 38/88, P = 0.010). There was no difference for the PASS (n = 19/88 vs. 26/94, P = 0.343).ConclusionsThis study indicates that spa therapy with home exercises may be superior to home exercise alone in the management of patients with GOA associated with knee OA.     

The effect of fluid resuscitation on the effective circulating volume in patients undergoing liver surgery: a post-hoc analysis of a randomized controlled trial

To assess the significance of an analogue of the mean systemic filling pressure (Pmsa) and its derived variables, in providing a physiology based discrimination between responders and non-responders to fluid resuscitation during liver surgery. A post-hoc analysis of data from 30 patients undergoing major hepatic surgery was performed. Patients received 15 ml kg^?1 fluid in 30 min. Fluid responsiveness (FR) was defined as an increase of 20% or greater in cardiac index, measured by FloTrac-Vigileo^®. Dynamic preload variables (pulse pressure variation and stroke volume variation: PPV, SVV) were recorded additionally. Pvr, the driving pressure for venous return (=Pmsa–central venous pressure) and heart performance (E_H; Pvr/Pmsa) were calculated according to standard formula. Pmsa increased following fluid administration in responders (n?=?18; from 13?±?3 to 17?±?4 mmHg, p?<?0.01) and in non-responders (n?=?12; from 14?±?4 to 17?±?4 mmHg, p?<?0.01). Pvr, which was lower in responders before fluid administration (6?±?1 vs. 7?±?1 mmHg; p?=?0.02), increased after fluid administration only in responders (from 6?±?1 to 8?±?1 mmHg; p?<?0.01). E_H only decreased in non-responders (from 0.56?±?0.17 to 0.45?±?0.12; p?<?0.05). The area under the receiver operating characteristics curve of Pvr, PPV and SVV for predicting FR was 0.75, 0.73 and 0.72, respectively. Changes in Pmsa, Pvr and E_H reflect changes in effective circulating volume and heart performance following fluid resuscitation, providing a physiologic discrimination between responders and non-responders. Also, Pvr predicts FR equivalently compared to PPV and SVV, and might therefore aid in predicting FR in case dynamic preload variables cannot be used.     

A low pulse pressure predicts mortality in subjects with heart failure after an acute myocardial infarction: a post-hoc analysis of the CAPRICORN study

Background  

In patients with cardiovascular disease, a high pulse pressure is related to an increased risk of cardiovascular events but in patients with advanced heart failure, a low pulse pressure is predictive of adverse (cardiovascular) events.     

B弱亚型表达调控的分子机制研究

目的 研究B抗原减弱血液标本的血清学特性和抗原表达减弱的分子机制.方法 选择2007年1月至2010年12月于本中心行常规ABO血型检测样本中,B抗原表达减弱的血液样本10份作为研究对象,纳入研究组;计算机随机选择5份正常B表现型的血液样本作为对照组.采用经典血清学技术检测红细胞ABO血型,聚合酶链反应(PCR)技术扩增ABO基因全部外显子序列和5’端调控(CBF/NF-Y增强子)序列,并进行测序分析,应用逆转录-PCR(RT-PCR)技术分析ABO cDNA转录剪接情况,采用重亚硫酸盐转化和克隆测序法分析ABO基因启动子区CpG岛甲基化水平.结果 研究组标本的血清学表现为B抗原明显减弱,全部外显子编码序列和拼接位点碱基无任何突变.ABO基因增强子未发现异常,存在着ABO基因全长cDNA转录本,未发现新的转录剪接体.与对照组比较,研究组10份标本在启动子区CpG岛均呈现不同程度的甲基化,其中6个标本在nt-26序列位点表现半甲基化状态.结论 ABO基因启动子区CpG岛中的甲基化位点可能是引起B抗原弱表达的原因.     

Eptinezumab improved patient-reported outcomes in patients with migraine and medication-overuse headache: Subgroup analysis of the randomized PROMISE-2 trial

Objective

To evaluate the effect of eptinezumab on patient-reported outcomes in patients with chronic migraine (CM) and medication-overuse headache (MOH).

Background

MOH is a secondary headache disorder commonly occurring in patients with CM and associated with functional and psychological impairments. Medication overuse and monthly headache and migraine days were reduced with eptinezumab compared with placebo as published previously; however, these outcomes do not fully capture the burden of migraine and treatment effect.

Methods

PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled trial in adults with CM. Patients were randomized (1:1:1) to receive eptinezumab 100 mg, eptinezumab 300 mg, or placebo (up to 2 doses, 12 weeks apart). Patients completed the following patient-reported outcomes: 6-item Headache Impact Test (HIT-6), Patient Global Impression of Change (PGIC), patient-identified most bothersome symptom (PI-MBS), and 36-item Short-Form Health Survey (SF-36).

Results

A total of 431 CM patients (139, 147, and 145 patients in the eptinezumab 100 mg, eptinezumab 300 mg, and placebo groups, respectively) had MOH diagnosed at screening (40.2% of the total PROMISE-2 population [n = 1072]). In CM with MOH patients, both doses of eptinezumab were associated with clinically meaningful improvements in mean HIT-6 total scores by week 4 and remained improved throughout the 24-week study. Responder rates for individual HIT-6 items were greater with eptinezumab than with placebo at all time points. At week 12, almost twice as many eptinezumab-treated patients indicated the PGIC was “much” or “very much” improved (58.5% [79/135, 100 mg] and 67.4% [95/147, 300 mg] vs. 35.8% [48/134, placebo]). Patients in the eptinezumab groups showed numerically greater improvements over placebo in the PI-MBS and SF-36 scores.

Conclusions

This subgroup analysis in patients with CM/MOH at baseline suggests that eptinezumab treatment is associated with early, sustained, and clinically meaningful improvements in patient-reported outcomes.     

Cervical facet force analysis after disc replacement versus fusion

BackgroundCervical total disc replacement was developed to preserve motion and reduce adjacent-level degeneration relative to fusion, yet concerns remain that total disc replacement will lead to altered facet joint loading and long-term facet joint arthrosis. This study is intended to evaluate changes in facet contact force, pressure and surface area at the treated and superior adjacent levels before and after discectomy, disc replacement, and fusion.MethodsTen fresh-frozen human cadaveric cervical spines were potted from C2 to C7 with pressure sensors placed into the facet joints of C3–C4 and C4–C5 via slits in the facet capsules. Moments were applied to the specimens to produce axial rotation, lateral bending and extension. Facet contact force and pressure were measured at both levels for intact, discectomy at C4–C5, disc replacement with ProDisc-C (Synthes Spine, West Chester, Pennsylvania, USA) at C4–C5, and anterior discectomy and fusion with Cervical Spine Locking Plate (Synthes Spine, West Chester, Pennsylvania, USA) at C4–C5. Facet contact area was calculated from the force and pressure measurements. An analysis of variance was used to determine significant differences with P-values < 0.05 indicating significance.FindingsFacet contact force was elevated at the treated level under extension following both discectomy and disc replacement, while facet contact pressure and area were relatively unchanged. Facet contact force and area were decreased at the treated level following fusion for all three loading conditions.InterpretationTotal disc replacement preserved facet contact force for all scenarios except extension at the treated level, highlighting the importance of the anterior disco-ligamentous complex. This could promote treated-level facet joint disease.