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1.
Objectives
The aim of this study was to compare conventional versus steerable catheter guided coronary sinus (CS) cannulation in patients with advanced heart failure undergoing cardiac resynchronization therapy (CRT).Background
Steerable catheter guided coronary sinus cannulation could reduce fluoroscopy time and contrast medium use during CRT implantation.Methods
176 consecutive patients with ischemic and non-ischemic heart failure undergoing CRT implantation from January 2008 to December 2012 at the University Hospital of Cologne were identified. During the study period two concurrent CS cannulation techniques were used: standard CS cannulation technique (standard-group, n = 113) and CS cannulation using a steerable electrophysiology (EP) catheter (EPCath-group, n = 63). Propensity-score matched pairs of conventional and EP-catheter guided CS cannulation made up the study population (n = 59 pairs). Primary endpoints were total fluoroscopy time and contrast medium amount used during procedure.Results
The total fluoroscopy time was 30.9 min (interquartile range (IQR), 19.9–44.0 min) in the standard-group and 23.4 min (IQR, 14.2-34-2 min) in the EPCath-group (p = 0.011). More contrast medium was used in the standard-group (60.0 ml, IQR, 30.0–100 ml) compared to 25.0 ml (IQR, 20.0–50.0 ml) in the EPCath-group (P<0.001).Conclusions
Use of steerable EP catheter was associated with significant reduction of fluoroscopy time and contrast medium use in patients undergoing CRT implantation. 相似文献2.
Matthias Rief Sarah Feger Peter Martus Michael Laule Marc Dewey Eva Sch?nenberger 《PloS one》2015,10(9)
Objectives
To evaluate how well patients with coronary stents accept combined coronary computed tomography angiography (CTA) and myocardial CT perfusion (CTP) compared with conventional coronary angiography (CCA).Background
While combined CTA and CTP may improve diagnostic accuracy compared with CTA alone, patient acceptance of CTA/CTP remains to be defined.Methods
A total of 90 patients with coronary stents prospectively underwent CTA/CTP (both with contrast agent, CTP with adenosine) and CCA as part of the CARS-320 study. In this group, an intraindividual comparison of patient acceptance of CTA, CTP, and CCA was performed.Results
CTP was experienced to be significantly more painful than CTA (p<0.001) and was associated with a higher frequency of dyspnea (p<0.001). Comparison of CTA/CTP with CCA revealed no significant differences in terms of pain (p = 0.141) and comfort (p = 0.377). Concern before CTA/CTP and CCA and overall satisfaction were likewise not significantly different (p = 0.097 and p = 0.123, respectively). Nevertheless, about two thirds (n = 60, 68%) preferred CTA/CTP to CCA (p<0.001). Moreover, patients felt less helpless during CTA/CTP than during CCA (p = 0.026). Lack of invasiveness and absence of pain were the most frequently mentioned advantages of CTA/CTP over CCA in our patient population.Conclusions
CCA and combined CTA/CTP are equally well accepted by patients; however, more patients prefer CTA/CTP. CTP was associated with more intense pain than CTA and more frequently caused dyspnea than CTA alone.Trial Registration
ClinicalTrials.gov NCT00967876 相似文献3.
Maxime Patout Bouchra Lamia Elodie Lhuillier Luis-Carlos Molano Catherine Viacroze Daniel Benhamou Jean-Fran?ois Muir Antoine Cuvelier 《PloS one》2015,10(9)
Background
Arterial punctures for assessment of arterial blood-gases can be a painful procedure. Lidocaine can be used to reduce pain prior to needle insertion but it is not a widely accepted practice. The purpose of this study was to determine whether a large size needle induces more pain compared to a smaller size needle for radial arterial puncture and to assess the anxiety associated with radial arterial punctures.Methods
We conducted a prospective, double-blind, randomized, controlled, monocentric study including all outpatients who had a planned assessment of arterial blood gas analysis. Patients were randomized to have the arterial puncture performed with a 23 or a 25 G needle. The main judgement criteria was pain during arterial puncture. Visual analogue scale for pain (VAS-P) and visual analogue scale for anxiety (VAS-A) were used to assess pain and anxiety during radial arterial puncture.Results
Two hundred consecutive patients were randomized. The 25 G needle was as painful as the 23 G needle (6.63 mm [0–19 mm] vs. 5.21 mm [0–18.49 mm], respectively, p = 0.527). Time for arterial puncture was longer with the 25 G needle than with the 23 G needle (42 s [35–55 s] vs. 33 s [24.5–35 s], respectively, p = 0.002). There was a correlation between the level of anxiety prior to the arterial puncture and the pain experienced by the patients (p: 0.369, p<0.0001). There was a correlation between the pain experienced by patients and the anxiety experienced in anticipation of another arterial puncture (p: 0.5124, p<0.0001).Conclusions
The use of 23 G needle allows quicker arterial sampling and is not associated with increased pain and symptoms. Anxiety was correlated with the pain experienced by patients during arterial punctures.Trial Registration
Clinicaltrials.gov: NCT02320916 相似文献4.
Alfred Chor San Chan Qiu Qiu Siu Wai Choi Stanley Sau Ching Wong Albert Chi Yan Chan Michael G Irwin Chi Wai Cheung 《PloS one》2016,11(2)
Background
Patients receiving total intravenous anesthesia (TIVA) with propofol have been shown to experience less postoperative pain. We evaluated the post-operative analgesic effects of propofol compared with sevoflurane maintenance of anesthesia in liver surgery. This study was registered at ClinicalTrials.gov (NCT02179437).Methods
In this retrospective study, records of patients who underwent liver surgery between 2010 and 2013 were reviewed. Ninety-five patients anesthetized with propofol TIVA were matched with 95 patients anesthetized with sevoflurane. Numeric pain rating scale (NRS) pain scores, postoperative morphine consumption, side effects and patients’ satisfaction with pain relief were evaluated.Results
The TIVA group reported lower NRS pain scores during coughing on postoperative days 1 and 2 but not 3 (p = 0.0127, p = 0.0472, p = 0.4556 respectively). They also consumed significantly less daily (p = 0.001 on day 1, p = 0.0231 on day 2, p = 0.0004 on day 3), accumulative (p = 0.001 on day 1, p<0.0001 on day 2 and p = 0.0064 on day 3) and total morphine (p = 0.03) when compared with the sevoflurane group. There were no differences in total duration of intravenous patient controlled analgesia (PCA) morphine use and patient satisfaction. No difference was found in reported side effects.Conclusion
Patients anesthetized with propofol TIVA reported less pain during coughing and consumed less daily, accumulative and total morphine after liver surgery. 相似文献5.
Akira Kogure Kazuhiko Kotani Shigehiko Katada Hiroshi Takagi Masahiro Kamikozuru Takashi Isaji Setsuo Hakata 《PloS one》2015,10(12)
Study design
cized, single-blind, controlled trial.Objective
To investigate the efficacy of the Arthrokinematic approach (AKA)-Hakata (H) method for chronic low back pain.Summary of Background Data
The AKA-H method is used to manually treat abnormalities of intra-articular movement.Methods
One hundred eighty-six patients with chronic nonspecific low back pain randomly received either the AKA-H method (AKA-H group) or the sham technique (S group) monthly for 6 months. Data were collected at baseline and once a month. Outcome measures were pain intensity (visual analogue scale [VAS]) and quality of life (the Roland-Morris Disability Questionnaire [RDQ] and Short Form SF-36 questionnaire [SF-36]).Results
At baseline, the VAS, RDQ, and SF-36 scores showed similar levels between the groups. After 6 months, the AKA-H group had more improvement in the VAS (42.8% improvement) and RDQ score (31.1% improvement) than the sham group (VAS: 10.4% improvement; RDQ: 9.8% improvement; both, P < 0.001). The respective scores for the SF-36 subscales (physical functioning, role physical, bodily pain, social functioning, general health perception, role emotional, and mental health) were also significantly more improved in the AKA-H group than in the sham group (all, P < 0.001). The scores for the physical, psychological, and social aspects of the SF-36 subscales showed similar improvement in the AKA-H group.Conclusion
The AKA-H method can be effective in managing chronic low back pain.Trial Registration
UMIN Clinical Trials Registry (UMIN-CTR) UMIN000006250. 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.
Purpose
To investigate whether carrying out various interventions part way through the day influences comfort in symptomatic daily disposable (DD) contact lens wearers.Methods
A subject-masked, randomized, controlled clinical trial was conducted in thirty symptomatic soft lens wearers who wore their habitual DD contact lenses bilaterally for 12 h on two separate days. Five hours after lens application, one of the following three interventions or a control was performed on each eye: replacing the existing lens with a new lens; removing and reapplying the same lens; performing a ‘scleral swish’; and no action (control). Comfort scores were recorded using SMS text messages every hour following lens application using a 0 (causes pain) to 100 (excellent comfort) scale. Comfort scores before lens application, at 6 mins post-application, and at 6 mins post-intervention were also recorded.Results
There was a significant reduction in comfort from pre-lens application to 6 mins post-application for all groups (all p<0.05). Comfort gradually decreased from 6 mins to 5 h after lens application for each group (p<0.0001) with no significant difference between groups over the 5-h period (p = 0.09). There was no significant difference in comfort 6 mins post-intervention for any group (all p>0.05). After the intervention, comfort continued to decline (p<0.0001) with slightly lower mean scores for the control group compared to the new lens group (p = 0.003). Change in comfort relative to pre-intervention (5 h) was similar for all groups (p = 0.81). There was no difference in comfort at 12 h between groups (p = 0.83).Conclusion
This work has confirmed that comfort shows a continual and significant decline over a 12-h wearing period in symptomatic DD contact lens wearers. None of the interventions investigated had any significant impact on end-of-day comfort. These data suggest discomfort in lens wearers is more heavily influenced by changes to the ocular environment rather than to the lens itself.Trial Registration
Controlled-Trials.com ISRCTN10419752 http://www.controlled-trials.com/ISRCTN10419752 相似文献8.
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9.
Christa Kasang Samuel Kalluvya Charles Majinge Gilbert Kongola Mathias Mlewa Irene Massawe Rogatus Kabyemera Kinanga Magambo Albrecht Ulmer Hartwig Klinker Eva Gschmack Anne Horn Eleni Koutsilieri Wolfgang Preiser Daniela Hofmann Johannes Hain Andreas Müller Lars D?lken Benedikt Weissbrich Axel Rethwilm August Stich Carsten Scheller 《PloS one》2016,11(1)
Background
HIV-disease progression correlates with immune activation. Here we investigated whether corticosteroid treatment can attenuate HIV disease progression in antiretroviral-untreated patients.Methods
Double-blind, placebo-controlled randomized clinical trial including 326 HIV-patients in a resource-limited setting in Tanzania (clinicaltrials.gov NCT01299948). Inclusion criteria were a CD4 count above 300 cells/μl, the absence of AIDS-defining symptoms and an ART-naïve therapy status. Study participants received 5 mg prednisolone per day or placebo for 2 years. Primary endpoint was time to progression to an AIDS-defining condition or to a CD4-count below 200 cells/μl.Results
No significant change in progression towards the primary endpoint was observed in the intent-to-treat (ITT) analysis (19 cases with prednisolone versus 28 cases with placebo, p = 0.1407). In a per-protocol (PP)-analysis, 13 versus 24 study participants progressed to the primary study endpoint (p = 0.0741). Secondary endpoints: Prednisolone-treatment decreased immune activation (sCD14, suPAR, CD38/HLA-DR/CD8+) and increased CD4-counts (+77.42 ± 5.70 cells/μl compared to -37.42 ± 10.77 cells/μl under placebo, p < 0.0001). Treatment with prednisolone was associated with a 3.2-fold increase in HIV viral load (p < 0.0001). In a post-hoc analysis stratifying for sex, females treated with prednisolone progressed significantly slower to the primary study endpoint than females treated with placebo (ITT-analysis: 11 versus 21 cases, p = 0.0567; PP-analysis: 5 versus 18 cases, p = 0.0051): No changes in disease progression were observed in men.Conclusions
This study could not detect any significant effects of prednisolone on disease progression in antiretroviral-untreated HIV infection within the intent-to-treat population. However, significant effects were observed on CD4 counts, immune activation and HIV viral load. This study contributes to a better understanding of the role of immune activation in the pathogenesis of HIV infection.Trial Registration
ClinicalTrials.gov NCT01299948 相似文献10.
Background
To determine whether the complementary approach of visceral manipulative osteopathic treatment accelerates complete meconium excretion and improves feeding tolerance in very low birth weight infants.Methods
This study was a prospective, randomized, controlled trial in premature infants with a birth weight <1500 g and a gestational age <32 weeks who received a visceral osteopathic treatment 3 times during their first week of life or no treatment.Results
Passage of the last meconium occurred after a median of 7.5 days (95% confidence interval: 6–9 days, n = 21) in the intervention group and after 6 days (95% confidence interval: 5-9 days, n = 20,) in the control group (p = 0.11). However, osteopathic treatment was associated with a 8 day longer time to full enteral feedings (p = 0.02), and a 34 day longer hospital stay (Median = 66 vs. 100 days i.e.; p=0.14). Osteopathic treatment was tolerated well and no adverse events were observed.Conclusions
Visceral osteopathic treatment of the abdomen did not accelerate meconium excretion in VLBW (very low birth weight)-infants. However infants in the osteopathic group had a longer time to full enteral feedings and a longer hospital stay, which could represent adverse effects. Based on our trial results, we cannot recommend visceral osteopathic techniques in VLBW-infants.Trial registration
Clinical trials.gov: NCT02140710 相似文献11.
Liang-Cheng Chen Cheng-Wen Ho Chia-Hung Sun Jiunn-Tay Lee Tsung-Ying Li Feng-Mei Shih Yung-Tsan Wu 《PloS one》2015,10(6)
Objective
We assessed the therapeutic efficiency of ultrasound-guided pulsed radiofrequency (PRF) treatment of the median nerve in patients with carpal tunnel syndrome (CTS).Methods
We conducted a prospective, randomized, controlled, single-blinded study. Forty-four patients with CTS were randomized into intervention or control groups. Patients in the intervention group were treated with PRF and night splint, and the control group was prescribed night splint alone. Primary outcome was the onset time of significant pain relief assessed using the visual analog scale (VAS), and secondary outcomes included evaluation of the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) results, cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity (SNCV) of the median nerve, and finger pinch strength. All outcome measurements were performed at 1, 4, 8, and 12 weeks after treatment.Results
Thirty-six patients completed the study. The onset time of pain relief in the intervention group was significantly shorter (median onset time of 2 days vs. 14 days; hazard ratio = 7.37; 95% CI, 3.04–17.87) compared to the control group (p < 0.001). Significant improvement in VAS and BCTQ scores (p < 0.05) was detected in the intervention group at all follow-up periods compared to the controls (except for the severity subscale of BCTQ at week 1). Ultrasound-guided PRF treatment resulted in a lower VAS score and stronger finger pinch compared to the control group over the entire study.Conclusions
Our study shows that ultrasound-guided PRF serves as a better approach for pain relief in patients with CTS.Trial Registration
ClinicalTrials.gov NCT02217293 相似文献12.
Jacqueline Kerr Michelle Takemoto Khalisa Bolling Andrew Atkin Jordan Carlson Dori Rosenberg Katie Crist Suneeta Godbole Brittany Lewars Claudia Pena Gina Merchant 《PloS one》2016,11(1)
Background
Excessive sitting has been linked to poor health. It is unknown whether reducing total sitting time or increasing brief sit-to-stand transitions is more beneficial. We conducted a randomized pilot study to assess whether it is feasible for working and non-working older adults to reduce these two different behavioral targets.Methods
Thirty adults (15 workers and 15 non-workers) age 50–70 years were randomized to one of two conditions (a 2-hour reduction in daily sitting or accumulating 30 additional brief sit-to-stand transitions per day). Sitting time, standing time, sit-to-stand transitions and stepping were assessed by a thigh worn inclinometer (activPAL). Participants were assessed for 7 days at baseline and followed while the intervention was delivered (2 weeks). Mixed effects regression analyses adjusted for days within participants, device wear time, and employment status. Time by condition interactions were investigated.Results
Recruitment, assessments, and intervention delivery were feasible. The ‘reduce sitting’ group reduced their sitting by two hours, the ‘increase sit-to-stand’ group had no change in sitting time (p < .001). The sit-to-stand transition group increased their sit-to-stand transitions, the sitting group did not (p < .001).Conclusions
This study was the first to demonstrate the feasibility and preliminary efficacy of specific sedentary behavioral goals.Trial Registration
clinicaltrials.gov NCT02544867 相似文献13.
Claudia Spies Alawi Luetz Gunnar Lachmann Markus Renius Clarissa von Haefen Klaus-Dieter Wernecke Marcus Bahra Alexander Schiemann Marco Paupers Christian Meisel 《PloS one》2015,10(12)
Purpose
Surgical patients are at high risk for developing infectious complications and postoperative delirium. Prolonged infections and delirium result in worse outcome. Granulocyte-macrophage colony-stimulating factor (GM-CSF) and influenza vaccination are known to increase HLA-DR on monocytes and improve immune reactivity. This study aimed to investigate whether GM-CSF or vaccination reverses monocyte deactivation. Secondary aims were whether it decreases infection and delirium days after esophageal or pancreatic resection over time.Methods
In this prospective, randomized, placebo-controlled, double-blind, double dummy trial setting on an interdisciplinary ICU of a university hospital 61 patients with immunosuppression (monocytic HLA-DR [mHLA-DR] <10,000 monoclonal antibodies [mAb] per cell) on the first day after esophageal or pancreatic resection were treated with either GM-CSF (250 μg/m2/d), influenza vaccination (Mutagrip 0.5 ml/d) or placebo for a maximum of 3 consecutive days if mHLA-DR remained below 10,000 mAb per cell. HLA-DR on monocytes was measured daily until day 5 after surgery. Infections and delirium were followed up for 9 days after surgery. Primary outcome was HLA-DR on monocytes, and secondary outcomes were duration of infection and delirium.Results
mHLA-DR was significantly increased compared to placebo (p < 0.001) and influenza vaccination (p < 0.001) on the second postoperative day. Compared with placebo, GM-CSF-treated patients revealed shorter duration of infection (p < 0.001); the duration of delirium was increased after vaccination (p = 0.003).Conclusion
Treatment with GM-CSF in patients with postoperative immune suppression was safe and effective in restoring monocytic immune competence. Furthermore, therapy with GM-CSF reduced duration of infection in immune compromised patients. However, influenza vaccination increased duration of delirium after major surgery.Trial Registration
www.controlled-trials.com ISRCTN27114642 相似文献14.
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15.
Hirofumi Nagayama Kounosuke Tomori Kanta Ohno Kayoko Takahashi Kakuya Ogahara Tatsunori Sawada Sei Uezu Ryutaro Nagatani Keita Yamauchi 《PloS one》2016,11(3)
Background
Care-home residents are mostly inactive, have little interaction with staff, and are dependent on staff to engage in daily occupations. We recently developed an iPad application called the Aid for Decision-making in Occupation Choice (ADOC) to promote shared decision-making in activities and occupation-based goal setting by choosing from illustrations describing daily activities. This study aimed to evaluate if interventions based on occupation-based goal setting using the ADOC could focus on meaningful activities to improve quality of life and independent activities of daily living, with greater cost-effectiveness than an impairment-based approach as well as to evaluate the feasibility of conducting a large cluster, randomized controlled trial.Method
In this single (assessor)-blind pilot cluster randomized controlled trial, the intervention group (ADOC group) received occupational therapy based on occupation-based goal setting using the ADOC, and the interventions were focused on meaningful occupations. The control group underwent an impairment-based approach focused on restoring capacities, without goal setting tools. In both groups, the 20-minute individualized intervention sessions were conducted twice a week for 4 months.Main Outcome Measures
Short Form-36 (SF-36) score, SF-6D utility score, quality adjusted life years (QALY), Barthel Index, and total care cost.Results
We randomized and analyzed 12 facilities (44 participants, 18.5% drop-out rate), with 6 facilities each allocated to the ADOC (n = 23) and control (n = 21) groups. After the 4-month intervention, the ADOC group had a significantly greater change in the BI score, with improved scores (P = 0.027, 95% CI 0.41 to 6.87, intracluster correlation coefficient = 0.14). No other outcome was significantly different. The incremental cost-effectiveness ratio, calculated using the change in BI score, was $63.1.Conclusion
The results suggest that occupational therapy using the ADOC for older residents might be effective and cost-effective. We also found that conducting an RCT in the occupational therapy setting is feasible.Trial Registration
UMIN Clinical Trials Registry UMIN000012994 相似文献16.
Maren Schmidt Rahel Eckardt Kathrin Scholtz Bruno Neuner Vera von Dossow-Hanfstingl Jalid Sehouli Christian G. Stief Klaus-Dieter Wernecke Claudia D. Spies PERATECS Group 《PloS one》2015,10(9)
Purpose
This randomized controlled, clinical prospective interventional trial was aimed at exploring the effect of patient empowerment on short- and long-term outcomes after major oncologic surgery in elderly cancer patients.Methods
This trial was performed from February 2011 to January 2014 at two tertiary medical centers in Germany. The study included patients aged 65 years and older undergoing elective surgery for gastro-intestinal, genitourinary, and thoracic cancer. The patients were randomly assigned to the intervention group, i.e. patient empowerment through information booklet and diary keeping, or to the control group, which received standard care. Randomization was done by block randomization in blocks of four in order of enrollment. The primary outcome were 1,postoperative length of hospital stay (LOS) and 2. long-term global health-related quality of life (HRQoL) one year postoperatively. HRQoL was assessed using the EORTC QLQ C30 questionnaire. Secondary outcomes encompassed postoperative stress and complications. Further objectives were the identification of predictors of LOS, and HRQoL at 12 months.Results
Overall 652 patients were included. The mean age was 72 ± 4.9 years, and the majority of patients were male (68.6%, n = 447). The ^median of postoperative length of stay was 9 days (IQR 7–14 day). There were no significant differences between the intervention and the control groups in postoperative LOS (p = 0.99) or global HRQoL after one year (women: p = 0.54, men: p = 0.94). While overall complications and major complications occurred in 74% and 24% of the cases, respectively, frequency and severity of complications did not differ significantly between the groups. Patients in the intervention group reported significantly less postoperative pain (p = 0.03) than the control group. Independent predictors for LOS were identified as severity of surgery, length of anesthesia, major postoperative complications, nutritional state, and pre-operative physical functional capacity measured by the Timed Up and Go-test by multiple robust regressions.Conclusion
Patient empowerment through information booklet and diary keeping did not shorten the postoperative LOS in elderly onco-surgical patients, but improved quality of care regarding postoperative pain. Postoperative length of stay is influenced by pre-operative nutritional state, pre-operative functional impairment, severity of surgery, and length of anesthesia.Trial Registration
Clinicaltrials.gov. Identifier NCT01278537 相似文献17.
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18.
Objective
To compare the effects of stress dose hydrocortisone therapy with placebo on survival without neurodevelopmental impairments in high-risk preterm infants.Study Design
We recruited 64 extremely low birth weight (birth weight ≤1000g) infants between the ages of 10 and 21 postnatal days who were ventilator-dependent and at high-risk for bronchopulmonary dysplasia. Infants were randomized to a tapering 7-day course of stress dose hydrocortisone or saline placebo. The primary outcome at follow-up was a composite of death, cognitive or language delay, cerebral palsy, severe hearing loss, or bilateral blindness at a corrected age of 18–22 months. Secondary outcomes included continued use of respiratory therapies and somatic growth.Results
Fifty-seven infants had adequate data for the primary outcome. Of the 28 infants randomized to hydrocortisone, 19 (68%) died or survived with impairment compared with 22 of the 29 infants (76%) assigned to placebo (relative risk: 0.83; 95% CI, 0.61 to 1.14). The rates of death for those in the hydrocortisone and placebo groups were 31% and 41%, respectively (P = 0.42). Randomization to hydrocortisone also did not significantly affect the frequency of supplemental oxygen use, positive airway pressure support, or need for respiratory medications.Conclusions
In high-risk extremely low birth weight infants, stress dose hydrocortisone therapy after 10 days of age had no statistically significant effect on the incidence of death or neurodevelopmental impairment at 18–22 months. These results may inform the design and conduct of future clinical trials.Trial Registration
ClinicalTrials.gov NCT00167544 相似文献19.
Marine Garguilo Michèle Lejaille Isabelle Vaugier David Orlikowski Nicolas Terzi Frédéric Lofaso Hélène Prigent 《PloS one》2016,11(3)
Background
Respiratory involvement in neuromuscular disorders may contribute to impaired breathing-swallowing interactions, swallowing disorders and malnutrition. We investigated whether the use of non-invasive ventilation (NIV) controlled by the patient could improve swallowing performances in a population of neuromuscular patients requiring daytime NIV.Methods
Ten neuromuscular patients with severe respiratory failure requiring extensive NIV use were studied while swallowing without and with NIV (while ventilated with a modified ventilator allowing the patient to withhold ventilation as desired). Breathing-swallowing interactions were investigated by chin electromyography, cervical piezoelectric sensor, nasal flow recording and inductive plethysmography. Two water-bolus sizes (5 and 10ml) and a textured yogurt bolus were tested in a random order.Results
NIV use significantly improved swallowing fragmentation (defined as the number of respiratory interruption of the swallowing of a single bolus) (p = 0.003) and breathing-swallowing synchronization (with a significant increase of swallows followed by an expiration) (p <0.0001). Patient exhibited piecemeal swallowing which was not influenced by NIV use (p = 0.07). NIV use also significantly reduced dyspnea during swallowing (p = 0.04) while preserving swallowing comfort, regardless of bolus type.Conclusion
The use of patient controlled NIV improves swallowing parameters in patients with severe neuromuscular respiratory failure requiring daytime NIV, without impairing swallowing comfort.Trial Registration
ClinicalTrials.gov NCT01519388 相似文献20.
Rüdiger Rupp Daniel Schlie?mann Harry Plewa Christian Schuld Hans Jürgen Gerner Norbert Weidner Eberhard P. Hofer Markus Knestel 《PloS one》2015,10(3)