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1.
Background
In real life, outcomes in wet age related macular degeneration (W-AMD) continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM).Methods
Multi-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, using reminder systems, performing structured follow-up, empowering patients in self-monitoring and giving decision-support). In the control usual care was continued. Main outcome measures were changes in ETDRS visual acuity, optical coherence tomography (OCT) macular retinal thickness and quality of life (NEI VFQ-25 questionnaire).Results
169 consecutive patients in Swiss ophthalmology centers were included. Mean ETDRS baseline visual acuity of eyes with W-AMD was 57.8 (± 18.7). After 12 months, the between-group difference in mean change of ETDRS visual acuity was -4.8 (95%CI: -10.8 to +1.2, p = 0.15); difference in mean change of OCT was +14.0 (95% CI -39.6 to 67.6, p = 0.60); difference in mean change of NEI VFQ-25 composite score mean change was +2.1(95%CI: -1.3 to +5.5, p = 0.19).Conclusions
The intervention aiming at improving chronic care was not associated with favorable outcomes within 12 months. Other approaches need to be tested to close the evidence-performance gap in W-AMD.Trial Registration
Controlled-Trials.com ISRCTN32507927 相似文献2.
Alberto Soriano-Maldonado Louise Klokker Cecilie Bartholdy Elisabeth Bandak Karen Ellegaard Henning Bliddal Marius Henriksen 《PloS one》2016,11(2)
Objective
To assess the effects of one intra-articular corticosteroid injection two weeks prior to an exercise-based intervention program for reducing pain sensitivity in patients with knee osteoarthritis (OA).Design
Randomized, masked, parallel, placebo-controlled trial involving 100 participants with clinical and radiographic knee OA that were randomized to one intra-articular injection on the knee with either 1 ml of 40 mg/ml methylprednisolone (corticosteroid) dissolved in 4 ml lidocaine (10 mg/ml) or 1 ml isotonic saline (placebo) mixed with 4 ml lidocaine (10 mg/ml). Two weeks after the injections all participants undertook a 12-week supervised exercise program. Main outcomes were changes from baseline in pressure-pain sensitivity (pressure-pain threshold [PPT] and temporal summation [TS]) assessed using cuff pressure algometry on the calf. These were exploratory outcomes from a randomized controlled trial.Results
A total of 100 patients were randomized to receive either corticosteroid (n = 50) or placebo (n = 50); 45 and 44, respectively, completed the trial. Four participants had missing values for PPT and one for TS at baseline; thus modified intention-to-treat populations were analyzed. The mean group difference in changes from baseline at week 14 was 0.6 kPa (95% CI: -1.7 to 2.8; P = 0.626) for PPT and 384 mm×sec (95% CI: -2980 to 3750; P = 0.821) for TS.Conclusions
These results suggest that adding intra-articular corticosteroid injection 2 weeks prior to an exercise program does not provide additional benefits compared to placebo in reducing pain sensitivity in patients with knee OA.Trial Registration
EU clinical trials (EudraCT): 2012-002607-18 相似文献3.
Denise M. D. ?zdemir-van Brunschot Giel G. Koning Kees C. J. H. M. van Laarhoven Mehmet Ergün Sharon B. C. E. van Horne Maroeska M. Rovers Michiel C. Warlé 《PloS one》2015,10(3)
Objective
To compare the effectiveness of different technique modifications in laparoscopic donor nephrectomy.Design
Systematic review and meta-analyses.Data Sources
Searches of PubMed, EMBASE, Web of Science and Central from January 1st 1997 until April 1st 2014.Study Design
All cohort studies and randomized clinical trials comparing fully laparoscopic donor nephrectomy with modifications of the standard technique including hand-assisted, retroperitoneoscopic and single port techniques, were included.Data-Extraction and Analysis
The primary outcome measure was the number of complications. Secondary outcome measures included: conversion to open surgery, first warm ischemia time, estimated blood loss, graft function, operation time and length of hospital stay. Each technique modification was compared with standard laparoscopic donor nephrectomy. Data was pooled with a random effects meta-analysis using odds ratios, weighted mean differences and their corresponding 95% confidence intervals. To assess heterogeneity, the I2 statistic was used. First, randomized clinical trials and cohort studies were analyzed separately, when data was comparable, pooled analysis were performed.Results
31 studies comparing laparoscopic donor nephrectomy with other technique modifications were identified, including 5 randomized clinical trials and 26 cohort studies. Since data of randomized clinical trials and cohort studies were comparable, these data were pooled. There were significantly less complications in the retroperitoneoscopic group as compared to transperitoneal group (OR 0.52, 95%CI 0.33–0.83, I2 = 0%). Hand-assisted techniques showed shorter first warm ischemia and operation times.Conclusions
Hand-assistance reduces the operation and first warm ischemia times and may improve safety for surgeons with less experience in laparoscopic donor nephrectomy. The retroperitoneoscopic approach was significantly associated with less complications. However, given the, in general, poor to intermediate quality and considerable heterogeneity in the included studies, further high-quality studies are required.Trial Registration
The review protocol was registered in the PROSPERO database before the start of the review process (CRD number 42013006565). 相似文献4.
Marni Wesner Terry Defreitas Heather Bredy Louisa Pothier Ziling Qin Ashley B. McKillop Douglas P. Gross 《PloS one》2016,11(2)
Objective
This pilot study aimed to inform future research evaluating the effectiveness of Platelet Rich Plasma (PRP) injection for tendinopathy.Design
Randomized control trial (RCT) and synchronous observational cohort studies. For the RCT, consecutive consenting patients treated at an academic sports medicine clinic were randomly assigned to either a PRP or placebo control group.Setting
The Glen Sather Sport Medicine Clinic, Edmonton, Canada.Patients
The RCT included 9 participants with rotator cuff tendinopathy. The cohort study included 178 participants with a variety of tendinopathies.Interventions
Patients receiving PRP were injected with 4 ml of platelets into the supraspinatus and/or infraspinatus, while patients in the placebo group were injected with 4ml of saline. All participants undertook a 3-month standardized, home-based, daily exercise program.Main Outcome Measures
Participants in the RCT were re-evaluated 3, and 6 months post-injection. Change scores before and after injection on pain, disability and MRI-documented pathology outcomes were compared. In the cohort study, pain and disability were measured at 1, 2 and 3 months post-injection.Results
For the RCT, 7 participants received PRP and 2 received placebo injections. Patients receiving PRP reported clinically important improvements in pain (>1.5/10 on VAS), disability (>15 point DASH change), and tendon pathology while those receiving placebo injections did not. In the observational cohort, statistically and clinically significant improvements in pain and disability were observed.Conclusion
This pilot study provides information for planning future studies of PRP effectiveness. Preliminary results indicate intratendinous, ultrasound-guided PRP injection may lead to improvements in pain, function, and MRI-documented tendon pathology.Trial Registration
Controlled-Trials.com ISRCTN68341698 相似文献5.
Background
To date, contemporary heart failure care remains patient-focused, but awareness of the partners’ and families’ situation is increasing. Randomized studies have mainly evaluated the short-term effects of dyadic interventions. Therefore, the aim of this study was to determine the 24-month effects of an intervention with psych-educational support in dyads of heart failure patients and their partners.Methods
This study used a randomized study design and 155 patient-partner dyads were enrolled. The intervention included a nurse-led program of three sessions addressing psychoeducational support.Results
The intervention did not have any effect on health, depressive symptoms or perceived control among the patient-partner dyads after 24 months. Furthermore, time to first event did not differ significantly between the intervention group and the control patients.Conclusion
This study may be regarded as a first step in trying to understand dyads’ need for supportive care. Individualized and more targeted interventions seem necessary to achieve a higher impact on dyad outcomes.Trial Registration
ClinicalTrials.gov NCT02398799 相似文献6.
Zaid Zoumot Samuel V. Kemp Suveer Singh Stephen R. Bicknell William H. McNulty Nicholas S. Hopkinson Ewen T. Ross Pallav L. Shah 《PloS one》2015,10(4)
Background
There is a clinical need for therapeutic options to reduce hyperinflation associated with severe emphysema. Endobronchial Coils (coils) are nitinol devices implanted bronchoscopically under fluoroscopic guidance to re-tension the lung. We report the medium term effectiveness and safety of coils in a study of patients with emphysema.Methods
Forty five subjects with severe airflow obstruction and hyperinflation received bilateral sequential treatment with coils (30 day interval between treatments) as part of a randomised controlled trial with a primary endpoint 90 days after the final treatment (Clinicaltrials.gov NCT01334307). Further assessments were made at 180 and 360 days and in this study the primary outcome was the effect of coil treatment on the St. George’s Respiratory Questionnaire (SGRQ) 360 days following treatment.Results
At 360 days following treatment, there was an improvement in the SGRQ score of -6.1±14.0 points (p = 0.01) compared to baseline. Improvements in secondary outcomes were seen with increases in forced expiratory volume in the first second of 8.9 ±22.2% (p = 0.002) and 6-minute walking distance of 34.1±52.4m (p = 0.003). The safety profile was acceptable out to 360 days post-treatment.Conclusions
Statistically and clinically meaningful benefits in quality of life, exercise capacity and pulmonary function in patients treated with coils are sustained twelve months after treatment.Trial registration information
Clinicaltrials.gov NCT01334307. 相似文献7.
Objective
To investigate efficacy of a contoured sandal being marketed for plantar heel pain with comparison to a flat flip-flop and contoured in-shoe insert/orthosis.Method
150 volunteers aged 50 (SD: 12) years with plantar heel pain (>4 weeks) were enrolled after responding to advertisements and eligibility determined by telephone and at first visit. Participants were randomly allocated to receive commercially available contoured sandals (n = 49), flat flip-flops (n = 50) or over the counter, pre-fabricated full-length foot orthotics (n = 51). Primary outcomes were a 15-point Global Rating of Change scale (GROC: 1 = a very great deal worse, 15 = a very great deal better), 13 to 15 representing an improvement and the 20-item Lower Extremity Function Scale (LEFS) on which participants rate 20 common weight bearing activities and activities of daily living on a 5-point scale (0 = extreme difficulty, 4 = no difficulty). Secondary outcomes were worst level of heel pain in the preceding week, and the foot and ankle ability measure. Outcomes were collected blind to allocation. Analyses were done on an intention to treat basis with 12 weeks being the primary outcome time of interest.Results
The contoured sandal was 68% more likely to report improvement in terms of GROC compared to flat flip-flop. On the LEFS the contoured sandal was 61% more likely than flat flip-flop to report improvement. The secondary outcomes in the main reflected the primary outcomes, and there were no differences between contoured sandal and shoe insert.Conclusions and Relevance
Physicians can have confidence in supporting a patient''s decision to wear contoured sandals or in-shoe orthoses as one of the first and simple strategies to manage their heel pain.Trial Registration
The Australian New Zealand Clinical Trials Registry ACTRN12612000463875 相似文献8.
Tine K. Grimholt Dag Jacobsen Ole Rikard Haavet Leiv Sandvik Trond Jorgensen Astrid Berge Norheim Oivind Ekeberg 《PloS one》2015,10(12)
Objective
To assess whether systematic follow-up by general practitioners (GPs) of cases of deliberate self-poisoning (DSP) by their patients decreases psychiatric symptoms and suicidal behaviour compared with current practice.Design
Randomised clinical trial with two parallel groups.Setting
General practices in Oslo and the eastern part of Akershus County.Participants
Patients aged 18–75 years admitted to hospital for DSP. We excluded patients diagnosed with psychoses, without a known GP, those not able to complete a questionnaire, and patients admitted to psychiatric in-patient care or other institutions where their GP could not follow them immediately after discharge.Intervention
The GPs received a written guideline, contacted the patients and scheduled a consultation within one week after discharge, and then provided regular consultations for six months. We randomised the patients to either intervention (n = 78) or treatment as usual (n = 98).Main Outcome Measures
Primary outcome measure was the Beck Scale for Suicide Ideation (SSI). Secondary outcomes were Beck Depression Inventory (BDI) and Beck Hopelessness Scale (BHS), self-reported further self-harm and treatment for DSP in a general hospital or an emergency medical agency (EMA). We assessed patients on entry to the trial and at three and six months. We collected data from interviews, self-report questionnaires, and hospital and EMA medical records.Results
There were no significant differences between the groups in SSI, BDI, or BHS mean scores or change from baseline to three or six months. During follow-up, self-reported DSP was 39.5% in the intervention group vs. 15.8% in controls (P = 0.009). Readmissions to general hospitals were similar (13% in both groups (P = 0.963), while DSP episodes treated at EMAs were 17% in the intervention group and 7% in the control group (P = 0.103).Conclusion
Structured follow-up by GPs after an episode of DSP had no significant effect on suicide ideation, depression or hopelessness. There was no significant difference in repeated episodes of DSP in hospitals or EMAs. However, the total number of incidents of deliberate self-harm reported by the patients was significantly higher in the intervention group.Trial registration
Trial registration ClinicalTrials.gov Identifier: NCT01342809 相似文献9.
J. Carlos Flores-González Miguel A. Matamala-Morillo Patricia Rodríguez-Campoy Juan J. Pérez-Guerrero Belén Serrano-Moyano Paloma Comino-Vazquez Encarnación Palma-Zambrano Rocio Bulo-Concellón Vanessa Santos-Sánchez Alfonso M. Lechuga-Sancho Bronchiolitis of Cadiz Study group 《PloS one》2015,10(11)
Background and Aims
There is no evidence that the epinephrine-3% hypertonic saline combination is more effective than 3% hypertonic saline alone for treating infants hospitalized with acute bronchiolitis. We evaluated the efficacy of nebulized epinephrine in 3% hypertonic saline.Patients and Methods
We performed a randomized, double-blind, placebo-controlled clinical trial in 208 infants hospitalized with acute moderate bronchiolitis. Infants were randomly assigned to receive nebulized 3% hypertonic saline with either 3 mL of epinephrine or 3 mL of placebo, administered every four hours. The primary outcome measure was the length of hospital stay.Results
A total of 185 infants were analyzed: 94 in the epinephrine plus 3% hypertonic saline group and 91 in the placebo plus 3% hypertonic saline group. Baseline demographic and clinical characteristics were similar in both groups. Length of hospital stay was significantly reduced in the epinephrine group as compared with the placebo group (3.94 ±1.88 days vs. 4.82 ±2.30 days, P = 0.011). Disease severity also decreased significantly earlier in the epinephrine group (P = 0.029 and P = 0.036 on days 3 and 5, respectively).Conclusions
In our setting, nebulized epinephrine in 3% hypertonic saline significantly shortens hospital stay in hospitalized infants with acute moderate bronchiolitis compared to 3% hypertonic saline alone, and improves the clinical scores of severity from the third day of treatment, but not before.Trial Registration
EudraCT 2009-016042-57 相似文献10.
Background
Recently, using the patient’s genotype to guide warfarin dosing has gained interest; however, whether pharmacogenetics-based dosing (PD) improves clinical outcomes compared to conventional dosing (CD) remains unclear. Thus, we performed a meta-analysis to evaluate these two strategies.Methods
The PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese VIP and Chinese Wan-fang databases were searched. The Cochrane Collaboration’s tool was used to assess the risk of bias in randomized controlled trials (RCTs). The primary outcome was time within the therapeutic range (TTR); the secondary end points were the time to maintenance dose and time to first therapeutic international normalized ratio (INR), an INR greater than 4, adverse events, major bleeding, thromboembolism and death from any cause.Results
A total of 11 trials involving 2,678 patients were included in our meta-analysis. The results showed that PD did not improve the TTR compared to CD, although PD significantly shortened the time to maintenance dose (MD = -8.80; 95% CI: -11.99 to -5.60; P<0.00001) and the time to first therapeutic INR (MD = -2.80; 95% CI: -3.45 to -2.15; P<0.00001). Additionally, PD significantly reduced the risk of adverse events (RR = 0.86; 95% CI: 0.75 to 0.99; P = 0.03) and major bleeding (RR = 0.36; 95% CI: 0.15 to 0.89, P = 0.03), although it did not reduce the percentage of INR greater than 4, the risk of thromboembolic events and death from any cause. Subgroup analysis showed that PD resulted in a better improvement in the endpoints of TTR and over-anticoagulation at a fixed initial dosage rather than a non-fixed initial dosage.Conclusions
The use of genotype testing in the management of warfarin anticoagulation was associated with significant improvements in INR-related and clinical outcomes. Thus, genotype-based regimens can be considered a reliable and accurate method to determine warfarin dosing and may be preferred over fixed-dose regimens.Trial Registration PROSPERO
Database registration: CRD42015024127. 相似文献11.
Context
Research-oriented cancer hospitals in the United States treat and study patients with a range of diseases. Measures of disease specific research productivity, and comparison to overall productivity, are currently lacking.Hypothesis
Different institutions are specialized in research of particular diseases.Objective
To report disease specific productivity of American cancer hospitals, and propose a summary measure.Method
We conducted a retrospective observational survey of the 50 highest ranked cancer hospitals in the 2013 US News and World Report rankings. We performed an automated search of PubMed and Clinicaltrials.gov for published reports and registrations of clinical trials (respectively) addressing specific cancers between 2008 and 2013. We calculated the summed impact factor for the publications. We generated a summary measure of productivity based on the number of Phase II clinical trials registered and the impact factor of Phase II clinical trials published for each institution and disease pair. We generated rankings based on this summary measure.Results
We identified 6076 registered trials and 6516 published trials with a combined impact factor of 44280.4, involving 32 different diseases over the 50 institutions. Using a summary measure based on registered and published clinical trails, we ranked institutions in specific diseases. As expected, different institutions were highly ranked in disease-specific productivity for different diseases. 43 institutions appeared in the top 10 ranks for at least 1 disease (vs 10 in the overall list), while 6 different institutions were ranked number 1 in at least 1 disease (vs 1 in the overall list).Conclusion
Research productivity varies considerably among the sample. Overall cancer productivity conceals great variation between diseases. Disease specific rankings identify sites of high academic productivity, which may be of interest to physicians, patients and researchers. 相似文献12.
Karlijn J. Barnhoorn J. Bart Staal Robert T. M. van Dongen Jan Paul M. Fr?lke Frank P. Klomp Henk van de Meent Han Samwel Maria W. G. Nijhuis-van der Sanden 《PloS one》2015,10(4)
Objective
To investigate whether pain-related fears are mediators for reducing disability and pain in patients with Complex Regional Pain Syndrome type 1 when treating with Pain Exposure Physical Therapy.Design
An explorative secondary analysis of a randomised controlled trial.Participants
Fifty-six patients with Complex Regional Pain Syndrome type 1.Interventions
The experimental group received Pain Exposure Physical Therapy in a maximum of five treatment sessions; the control group received conventional treatment following the Dutch multidisciplinary guideline.Outcome measures
Levels of disability, pain, and pain-related fears (fear-avoidance beliefs, pain catastrophizing, and kinesiophobia) were measured at baseline and after 3, 6, and 9 months follow-up.Results
The experimental group had a significantly larger decrease in disability of 7.77 points (95% CI 1.09 to 14.45) and in pain of 1.83 points (95% CI 0.44 to 3.23) over nine months than the control group. The potential mediators pain-related fears decreased significantly in both groups, but there were no significant differences between groups, which indicated that there was no mediation.Conclusion
The reduction of pain-related fears was comparable in both groups. We found no indication that pain-related fears mediate the larger reduction of disability and pain in patients with Complex Regional Pain Syndrome type 1 treated with Pain Exposure Physical Therapy compared to conventional treatment.Trial registration
International Clinical Trials Registry NCT00817128 相似文献13.
Susan Jordan Marie Ellenor Gabe-Walters Alan Watkins Ioan Humphreys Louise Newson Sherrill Snelgrove Michael S Dennis 《PloS one》2015,10(10)
Background
People with dementia are susceptible to adverse drug reactions (ADRs). However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines’ monitoring.Design
Pragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines’ monitoring versus usual care.Setting
Five UK private sector care homesParticipants
41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine.Intervention
Nurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step.Outcomes
Problems addressed and changes in medicines prescribed.Data Collection and Analysis
Information was collected from participants’ notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site.Results
Five of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57–4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78–8.30), and more patients attended dentists and opticians (aOR 52.76 [11.80–235.90] and 5.12 [1.45–18.03] respectively). Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15–17.22).Conclusion
The WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse effects of prescribed medicines.Trial Registration
ISRCTN 48133332 相似文献14.
Usha Ramakrishnan Amanda Stinger Ann M. DiGirolamo Reynaldo Martorell Lynnette M. Neufeld Juan A. Rivera Lourdes Schnaas Aryeh D. Stein Meng Wang 《PloS one》2015,10(8)
Objective
We evaluated the effects of prenatal docosahexaenoic acid (DHA) supplementation on offspring development at 18 months of age.Design
Randomized placebo double-blind controlled trial.Settings
Cuernavaca, Mexico.Participants and Methods
We followed up offspring (n = 730; 75% of the birth cohort) of women in Mexico who participated in a trial of DHA supplementation during the latter half of pregnancy. We assessed the effect of the intervention on child development and the potential modifying effects of gravidity, gender, SES, and quality of the home environment.Interventions or Main Exposures
400 mg/day of algal DHA.Outcome Measures
Child development at 18 months of age measured using the Spanish version of the Bayley Scales of Infant Development-II. We calculated standardized psychomotor and mental development indices, and behavior rating scale scores.Results
Intent-to-treat differences (DHA-control) were: Psychomotor Developmental Index -0.90 (95% CI: -2.35, 0.56), Mental Developmental Index -0.26 (95% CI: -1.63, 1.10) and Behavior Rating Scale -0.01 (95% CI: -0.95, 0.94). Prenatal DHA intake attenuated the positive association between home environment and psychomotor development index observed in the control group (p for interaction = 0.03) suggesting potential benefits for children living in home environments characterized by reduced caregiver interactions and opportunities for early childhood stimulation.Conclusions
Prenatal DHA supplementation in a population with low intakes of DHA had no effects on offspring development at 18 months of age although there may be some benefit for infants from poor quality home environments.Trial Registration
Clinicaltrials.gov NCT00646360 相似文献15.
Liesbeth Hempenius Joris P. J. Slaets Dieneke van Asselt Truuske H. de Bock Theo Wiggers Barbara L. van Leeuwen 《PloS one》2016,11(2)
Background
The aim of this study was to evaluate the long term effects after discharge of a hospital-based geriatric liaison intervention to prevent postoperative delirium in frail elderly cancer patients treated with an elective surgical procedure for a solid tumour. In addition, the effect of a postoperative delirium on long term outcomes was examined.Methods
A three month follow-up was performed in participants of the Liaison Intervention in Frail Elderly study, a multicentre, prospective, randomized, controlled trial. Patients were randomized to standard treatment or a geriatric liaison intervention. The intervention consisted of a preoperative geriatric consultation, an individual treatment plan targeted at risk factors for delirium and daily visits by a geriatric nurse during the hospital stay. The long term outcomes included: mortality, rehospitalisation, Activities of Daily Living (ADL) functioning, return to the independent pre-operative living situation, use of supportive care, cognitive functioning and health related quality of life.Results
Data of 260 patients (intervention n = 127, Control n = 133) were analysed. There were no differences between the intervention group and usual-care group for any of the outcomes three months after discharge. The presence of postoperative delirium was associated with: an increased risk of decline in ADL functioning (OR: 2.65, 95% CI: 1.02–6.88), an increased use of supportive assistance (OR: 2.45, 95% CI: 1.02–5.87) and a decreased chance to return to the independent preoperative living situation (OR: 0.18, 95% CI: 0.07–0.49).Conclusions
A hospital-based geriatric liaison intervention for the prevention of postoperative delirium in frail elderly cancer patients undergoing elective surgery for a solid tumour did not improve outcomes 3 months after discharge from hospital. The negative effect of a postoperative delirium on late outcome was confirmed.Trial Registration
Nederlands Trial Register, Trial ID NTR 823. 相似文献16.
J?rg Wiltink Jürgen Hoyer Manfred E. Beutel Christian Ruckes Stephan Herpertz Peter Joraschky Susan Koranyi Matthias Michal Bj?rn Nolting Karin P?hlmann Simone Salzer Bernhard Strauss Eric Leibing Falk Leichsenring 《PloS one》2016,11(1)
Objectives
Little is known about patient characteristics as predictors for outcome in manualized short term psychodynamic psychotherapy (PDT). No study has addressed which patient variables predict outcome of PDT for social anxiety disorder.Research Design and Methods
In the largest multicenter trial on psychotherapy of social anxiety (SA) to date comparing cognitive therapy, PDT and wait list condition N = 230 patients were assigned to receive PDT, of which N = 166 completed treatment. Treatment outcome was assessed based on diverse parameters such as endstate functioning, remission, response, and drop-out. The relationship between patient characteristics (demographic variables, mental co-morbidity, personality, interpersonal problems) and outcome was analysed using logistic and linear regressions.Results
Pre-treatment SA predicted up to 39 percent of variance of outcome. Only few additional baseline characteristics predicted better treatment outcome (namely, lower comorbidity and interpersonal problems) with a limited proportion of incremental variance (5.5 to 10 percent), while, e.g., shame, self-esteem or harm avoidance did not.Conclusions
We argue that the central importance of pre-treatment symptom severity for predicting outcomes should advocate alternative treatment strategies (e.g. longer treatments, combination of psychotherapy and medication) in those who are most disturbed. Given the relatively small amount of variance explained by the other patient characteristics, process variables and patient-therapist interaction should additionally be taken into account in future research.Trial Registration
Controlled-trials.com/ISRCTN53517394 相似文献17.
Evelim L. F. D. Gomes Celso R. F. Carvalho Fabiana Sobral Peixoto-Souza Etiene Farah Teixeira-Carvalho Juliana Fernandes Barreto Mendon?a Roberto Stirbulov Luciana Maria Malosá Sampaio Dirceu Costa 《PloS one》2015,10(8)
Objective
The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma.Design
A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function.Results
No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG.Conclusion
The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation.Trial Registration
Clinicaltrials.gov NCT01438294 相似文献18.
Cristina Lopes Jose Soares Freni Tavaria Ana Duarte Osvaldo Correia Oksana Sokhatska Milton Severo Diana Silva Manuela Pintado Luis Delgado Andre Moreira 《PloS one》2015,10(11)
Background
Atopic dermatitis (AD) patients may benefit from using textiles coated with skin microbiome–modulating compounds. Chitosan, a natural biopolymer with immunomodulatory and antimicrobial properties, has been considered potentially useful.Objective
This randomized controlled trial assessed the clinical utility of chitosan-coated garment use in AD.Methods
Of the 102 patients screened, 78 adult and adolescents were randomly allocated to overnight use of chitosan-coated or uncoated cotton long-sleeved pyjama tops and pants for 8 weeks. The primary outcome was change in disease severity assessed by Scoring Atopic dermatitis index (SCORAD). Other outcomes were changes in quality of life, pruritus and sleep loss, days with need for rescue medication, number of flares and controlled weeks, and adverse events. Changes in total staphylococci and Staphylococcus aureus skin counts were also assessed. Comparisons were made using analysis of variance supplemented by repeated measures analysis for the primary outcome. Interaction term between time and intervention was used to compare time trends between groups.Results
Chitosan group improved SCORAD from baseline in 43.8%, (95%CI: 30.9 to 55.9), P = 0.01, placebo group in 16.5% (-21.6 to 54.6); P = 0.02 with no significant differences between groups; Dermatology Quality of life Index Score significantly improved in chitosan group (P = 0.02) and a significant increase of skin Coagulase negative Staphylococci (P = 0.02) was seen.Conclusions
Chitosan coated textiles may impact on disease severity by modulating skin staphylococcal profile. Moreover, a potential effect in quality of life may be considered.Trial Registration
ClinicalTrials.gov NCT01597817 相似文献19.
Yulian Zhang Cuiru Lin Linlin Zhang Yuanwu Cui Yun Gu Jiakui Guo Di Wu Qiang Li Wanshan Song 《PloS one》2015,10(6)
Objectives
To explore the efficacy of Chinese herbal formula compared with donepezil 5mg/day in patients with mild Alzheimer’s disease (AD).Methods
Patients with mild AD meeting the criteria were randomized into Chinese herbal formula Yishen Huazhuo decoction (YHD) group and donepezil hydrochloride (DH) group during the 24-week trial. The outcomes were measured by ADAS-cog, MMSE, ADL, and NPI with linear mixed-effect models.Results
144 patients were randomized. The mean scores of ADAS-cog and MMSE in both YHD group and DH group both improved at the end of the 24-week treatment period. The results also revealed that YHD was better at improving the mean scores of ADAS-cog and MMSE than DH. Linear mixed-effect models with repeated measures showed statistical significance in time × group interaction effect of ADAS-cog and also in time × group interaction effect of MMSE. The data showed YHD was superior to DH in improving the scores and long term efficacy.Conclusions
Our study suggests that Chinese herbal formula YHD is beneficial and effective for cognitive improvement in patients with mild AD and the mechanism might be through reducing amyloid-β (Aβ) plaque deposition in the hippocampus.Trial Registration
Chinese Clinical Trial Registry ChiCTR-TRC-12002846 相似文献20.