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Secondary Outcomes (secondary + outcome)
Terms modified by Secondary Outcomes Selected AbstractsPerformance of a World Health Organization first-line regimen (stavudine/lamivudine/nevirapine) in antiretroviral-naïve individuals in a Western settingHIV MEDICINE, Issue 5 2007LWY Tam Objectives In 2003, the World Health Organization (WHO) and Joint United Nations Programme on HIV/AIDS (UNAIDS) introduced the ,3 by 5 Initiative' to treat 3 million individuals by the end of 2005. This study evaluates the time to treatment termination, viral load suppression, and detection of drug resistance among antiretroviral-naïve individuals initiating stavudine/lamivudine/nevirapine (d4T/3TC/NVP) in British Columbia, Canada, to provide a context for future programme planning. Methods Primary outcome was time to treatment termination. Secondary outcome was time to viral suppression. Accumulation of drug resistance mutations was followed systematically in the first 145 individuals over 30 months. Cox proportional hazard regression identified factors associated with termination and suppression. Results 312 antiretroviral-naïve individuals initiated d4T/3TC/NVP between August 1996 and September 2003. Median follow-up time was 26.5 months (interquartile range [IQR] 6.8,46.5). At a median of 12.4 months (IQR 4.3,33.3), 132 (42.3%) patients switched treatment, 53 (17.0%) stopped therapy and 26 (8.3%) died. Of 308 subjects with baseline viral load >500 copies/mL, 223 (72.4%) suppressed to ,500 copies/mL at a median of 2.0 months. Among 145 (46.5%) individuals followed longitudinally, resistance mutations to NNRTI, 3TC, or other NRTI were detected in 11 (7.6%), six (4.1%) and four (2.8%) individuals after 12 months of therapy; and in 23 (15.9%), 17 (12.0%), and six (4.1%) individuals after 30 months. Conclusions The population requiring second-line treatment was 30% at 12 months and 40% at 24 months; 20% had detectable drug resistance mutations by 30 months. While these results are from a Western setting, they illustrate the need to consider second- and third-line approaches as antiretroviral treatment scale-up continues in the developing world. [source] Patient-directed strategy to reduce prescribing for patients with dyspepsia in general practice: a randomized trialALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 8 2004N. Krol Summary Background :,The percentage of patients receiving long-term treatment with acid suppressive drugs, mainly proton pump inhibitors, is higher than the prevalence of diseases that are commonly accepted as the proper indication for long-term proton pump inhibitor use. Aim :,To evaluate whether a patient-directed intervention (direct mail) reduced the prescription of antisecretory medication for dyspepsia in general practice. Methods :,A cluster-randomized trial was performed. One hundred and thirteen chronic users of proton pump inhibitors were recruited by 20 general practitioners. An unsolicited information leaflet was sent to patients that suggested stopping or reducing the use of proton pump inhibitors. The number of patients who stopped or reduced proton pump inhibitor use was measured at 12 and 20 weeks after the intervention. Secondary outcome measures were dyspepsia symptom severity and perceived quality of life measured at 12 weeks after the intervention. Results :,Fourteen of the 59 (24%) intervention group patients stopped or reduced their use of proton pump inhibitors, compared with three of the 45 (7%) control group patients (relative risk ratio 3.56; CI 95%: 1.088,11.642). Dyspepsia symptom severity and quality of life did not change. Conclusions :,A simple patient-directed intervention reduced the volume of long-term prescriptions of proton pump inhibitors in patients with dyspepsia. [source] Treatment of unipolar psychotic depression: a randomized, double-blind study comparing imipramine, venlafaxine, and venlafaxine plus quetiapineACTA PSYCHIATRICA SCANDINAVICA, Issue 3 2010J. Wijkstra Wijkstra J, Burger H, van den Broek WW, Birkenhäger TK, Janzing JGE, Boks MPM, Bruijn JA, van der Loos MLM, Breteler LMT, Ramaekers GMGI, Verkes RJ, Nolen WA. Treatment of unipolar psychotic depression: a randomized, double-blind study comparing imipramine, venlafaxine, and venlafaxine plus quetiapine. Objective:, It remains unclear whether unipolar psychotic depression should be treated with an antidepressant and an antipsychotic or with an antidepressant alone. Method:, In a multi-center RCT, 122 patients (18,65 years) with DSM-IV-TR psychotic major depression and HAM-D-17 , 18 were randomized to 7 weeks imipramine (plasma-levels 200,300 ,g/l), venlafaxine (375 mg/day) or venlafaxine,quetiapine (375 mg/day, 600 mg/day). Primary outcome was response on HAM-D-17. Secondary outcomes were response on CGI and remission (HAM-D-17). Results:, Venlafaxine,quetiapine was more effective than venlafaxine with no significant differences between venlafaxine,quetiapine and imipramine, or between imipramine and venlafaxine. Secondary outcomes followed the same pattern. Conclusion:, That unipolar psychotic depression should be treated with a combination of an antidepressant and an antipsychotic and not with an antidepressant alone, can be considered evidence based with regard to venlafaxine,quetiapine vs. venlafaxine monotherapy. Whether this is also the case for imipramine monotherapy is likely, but cannot be concluded from the data. [source] Venlafaxine monotherapy in bipolar type II depressed patients unresponsive to prior lithium monotherapyACTA PSYCHIATRICA SCANDINAVICA, Issue 3 2010J. D. Amsterdam Amsterdam JD, Wang G, Shults J. Venlafaxine monotherapy in bipolar type II depressed patients unresponsive to prior lithium monotherapy. Objective:, We examine the safety and efficacy of venlafaxine monotherapy in bipolar type II (BP II) patients with major depressive episode (MDE) who were unresponsive to prior lithium monotherapy. We hypothesized that venlafaxine would be superior to lithium with a low hypomanic conversion rate. Method:, Seventeen patients who were unresponsive to prior lithium monotherapy were crossed to venlafaxine monotherapy for 12 weeks. The primary outcome was within-subject change in total Hamilton Depression Rating (HAM-D) score over time. Secondary outcomes included the change in Young Mania Rating (YMRS) and clinical global impressions severity (CGI/S) and change (CGI/C) scores. Results:, Venlafaxine produced significantly greater reductions in HAM-D (P < 0.0005), CGI/S (P < 0.0005), and CGI/C (P < 0.0005) scores vs. prior lithium. There was no difference in mean YMRS scores between treatment conditions (P = 0.179). Conclusion:, Venlafaxine monotherapy may be a safe and effective monotherapy of BP II MDE with a low hypomanic conversion rate in lithium non-responders. [source] Diabetes Care Protocol: effects on patient-important outcomes.DIABETIC MEDICINE, Issue 4 2010A cluster randomized, non-inferiority trial in primary care Diabet. Med. 27, 442,450 (2010) Abstract Aims, The Diabetes Care Protocol (DCP) combines task delegation, intensification of diabetes treatment and feedback. It reduces cardiovascular risk in Type 2 diabetes (T2DM) patients. This study determines the effects of DCP on patient-important outcomes. Methods, A cluster randomized, non-inferiority trial, by self-administered questionnaires in 55 Dutch primary care practices: 26 practices DCP (1699 patients), 26 usual care (1692 patients). T2DM patients treated by their general practitioner were included. Main outcome was the 1-year between-group difference in Diabetes Health Profile (DHP-18) total score. Secondary outcomes: DHP-18 subscales, general perceived health [Medical Outcomes Study 36-Items Short Form Health Survey (SF-36), Euroqol 5 Dimensions (EQ-5D) and Euroqol visual analogue scale (EQ-VAS)], treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire; DTSQ status) and psychosocial self-efficacy (Diabetes Empowerment Scale Short Form; DES-SF). Per protocol (PP) and intention-to-treat (ITT) analyses were performed: non-inferiority margin , = ,2%. At baseline 2333 questionnaires were returned and 1437 1 year thereafter. Results, Comparing DCP with usual care, DHP-18 total score was non-inferior: PP ,0.88 (95% CI ,1.94 to 0.12), ITT ,0.439 (95% CI ,1.01 to 0.08), SF-36 ,health change' improved: PP 3.51 (95% CI 1.23 to 5.82), ITT 1.91 (95% CI 0.62 to 3.23), SF-36 ,social functioning' was inconclusive: PP ,1.57 (95% CI ,4.3 to 0.72), ITT ,1.031 (95% CI ,2.52 to ,0.25). Other DHP and SF-36 scores were inconsistent or non-inferior. DHP-18 ,disinhibited eating' was significantly worse in PP analyses. For EQ-5D/EQ-VAS, DTSQ and DES-SF, no significant between-group differences were found. Conclusion, DCP does not seem to influence health status negatively, therefore diabetes care providers should not shrink from intensified treatment. However, they should take possible detrimental effects on ,social functioning' and ,disinhibited eating' into account. [source] Human Patient Simulation Is Effective for Teaching Paramedic Students Endotracheal IntubationACADEMIC EMERGENCY MEDICINE, Issue 9 2005FRCPC, Robert E. Hall BSc Abstract Objectives: The primary purpose of this study was to determine whether the endotracheal intubation (ETI) success rate is different among paramedic students trained on a human patient simulator versus on human subjects in the operating room (OR). Methods: Paramedic students (n= 36) with no prior ETI training received identical didactic and mannequin teaching. After randomization, students were trained for ten hours on a patient simulator (SIM) or with 15 intubations on human subjects in the OR. All students then underwent a formalized test of 15 intubations in the OR. The primary outcome was the rate of successful intubation. Secondary outcomes were the success rate at first attempt and the complication rate. The study was powered to detect a 10% difference for the overall success rate (,= 0.05, ,= 0.20). Results: The overall intubation success rate was 87.8% in the SIM group and 84.8% in the OR group (difference of 3.0% [95% confidence interval {CI} =,4.2% to 10.1%; p = 0.42]). The success rate on the first attempt was 84.4% in the SIM group and 80.0% in the OR group (difference of 4.4% [95% CI =,3.4% to 12.3%; p = 0.27]). The complication rate was 6.3% in the SIM group and 4.4% in the OR group (difference of 1.9% [95% CI =,2.9% to 6.6%; p = 0.44]). Conclusions: When tested in the OR, paramedic students who were trained in ETI on a simulator are as effective as students who trained on human subjects. The results support using simulators to teach ETI. [source] Obese Patients with Abdominal Pain Presenting to the Emergency Department Do Not Require More Time or Resources for Evaluation Than Nonobese PatientsACADEMIC EMERGENCY MEDICINE, Issue 8 2005Timothy F. Platts-Mills MD Abstract Objectives: The authors describe the evaluation of obese and nonobese adult patients with abdominal pain presenting to an emergency department (ED). The hypothesis was that more ED and hospital resources are used to evaluate and treat obese patients. Methods: A prospective observational study of obese (n= 98; body mass index ,30 kg/m2) and nonobese (n= 176; body mass index < 30 kg/m2) adults presenting to the ED with abdominal pain was performed. ED length of stay (LOS) was the primary outcome. Secondary outcomes included use of laboratory tests, computed tomography, and ultrasonography, and rates of consultations, operations, and admissions. ED diagnoses were compared between the two groups. Results: Obese patients were older (41.9 vs. 38.3 years; p = 0.027) and more often female (69% vs. 51%; p = 0.003) than nonobese patients. There were no significant differences between obese and nonobese patients in either the primary or the secondary outcome measures. Obese patients were similar to nonobese patients in regard to LOS (457 vs. 486 minutes), laboratory studies (3.2 vs. 2.9 tests), abdominopelvic computed tomographic scans (30% vs. 31%), and abdominal ultrasounds (16% vs. 13%). Obese and nonobese patients were also similar in their rates of consultations (27% vs. 31%), operations (14% vs. 12%), and admissions (18% vs. 24%). No difference was found for LOS between obese and nonobese patients as evaluated by the Wilcoxon rank-sum test (p = 0.81). Logistic regression analysis controlling for baseline characteristics revealed no significant differences between obese and nonobese patients for secondary outcome variables. ED diagnoses for obese and nonobese patients were similar except that genitourinary diagnoses were less common in obese patients (8% vs. 21%; p = 0.01). Conclusions: In contradiction to the hypothesis, the results suggest that LOS and ED resource use in obese patients with abdominal pain are not increased when compared with nonobese patients. [source] Pre-cessation nicotine replacement therapy: pragmatic randomized trialADDICTION, Issue 8 2010Chris Bullen ABSTRACT Aims To determine the effectiveness of 2 weeks' pre-cessation nicotine patches and/or gum on smoking abstinence at 6 months. Design Pragmatic randomized controlled trial. Setting New Zealand. Participants Eleven hundred adult, dependent smokers who called the New Zealand Quitline between March 2006 and May 2007 for support to stop smoking were randomized to 2 weeks of nicotine patches and/or gum prior to their target quit day followed by usual care (8 weeks of patches and/or gum plus support calls from a Quitline adviser), or to usual care alone. Measurements The primary outcome was self-reported 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cotinine-verified abstinence, daily cigarette consumption, withdrawal symptoms and adverse events. Findings Six months after quit day 125 (22.7%) participants in the pre-cessation group and 116 (21.0%) in the control group reported 7-day point prevalence abstinence (relative risk 1.08 95% CI: 0.86, 1.35, P = 0.4, risk difference 1.7%, 95% CI: ,3.2%, 6.6%). However, when pooled in a meta-analysis with other pre-cessation trials a moderate benefit of about a one-quarter increase in cessation rates was evident. There was no difference in adverse events between groups. Conclusions In this, the largest pre-cessation NRT trial to date, using NRT 2 weeks before the target quit day was safe and well tolerated but offered no benefit over usual care. However, in conjunction with previous pre-cessation trials there appears to be a moderate benefit, but not as large as that seen in most smaller trials. [source] Randomized controlled trial comparing the effectiveness and safety of intranasal and intramuscular naloxone for the treatment of suspected heroin overdoseADDICTION, Issue 12 2009Debra Kerr ABSTRACT Aims Traditionally, the opiate antagonist naloxone has been administered parenterally; however, intranasal (i.n.) administration has the potential to reduce the risk of needlestick injury. This is important when working with populations known to have a high prevalence of blood-borne viruses. Preliminary research suggests that i.n. administration might be effective, but suboptimal naloxone solutions were used. This study compared the effectiveness of concentrated (2 mg/ml) i.n. naloxone to intramuscular (i.m.) naloxone for suspected opiate overdose. Methods This randomized controlled trial included patients treated for suspected opiate overdose in the pre-hospital setting. Patients received 2 mg of either i.n. or i.m. naloxone. The primary outcome was the proportion of patients who responded within 10 minutes of naloxone treatment. Secondary outcomes included time to adequate response and requirement for supplementary naloxone. Data were analysed using multivariate statistical techniques. Results A total of 172 patients were enrolled into the study. Median age was 29 years and 74% were male. Rates of response within 10 minutes were similar: i.n. naloxone (60/83, 72.3%) compared with i.m. naloxone (69/89, 77.5%) [difference: ,5.2%, 95% confidence interval (CI) ,18.2 to 7.7]. No difference was observed in mean response time (i.n.: 8.0, i.m.: 7.9 minutes; difference 0.1, 95% CI ,1.3 to 1.5). Supplementary naloxone was administered to fewer patients who received i.m. naloxone (i.n.: 18.1%; i.m.: 4.5%) (difference: 13.6%, 95% CI 4.2,22.9). Conclusions Concentrated intranasal naloxone reversed heroin overdose successfully in 82% of patients. Time to adequate response was the same for both routes, suggesting that the i.n. route of administration is of similar effectiveness to the i.m. route as a first-line treatment for heroin overdose. [source] The 40-mg dose of eletriptan: comparative efficacy and tolerability versus sumatriptan 100 mgEUROPEAN JOURNAL OF NEUROLOGY, Issue 2 2004Hans-Christoph Diener Meta-analysis provides valuable information regarding relative efficacies of triptans, but head-to-head comparator studies remain the gold standard. Three similar head-to-head trials comparing eletriptan 40 mg (E40) with sumatriptan 100 mg (S100) provide a rare opportunity and sufficient power, for robust comparisons of efficacy. Data were combined from three double-blind, placebo-controlled, first-dose, first-attack acute migraine treatment studies comparing E40 (n = 1132), S100 (n = 1129), and placebo (n = 645). The primary outcome was headache response at 2 h. Secondary outcomes included headache response at 1 h, pain-free and functional responses, and sustained headache and pain-free responses. Odds ratios were calculated for summary estimates of probability of response. There were higher headache response rates with eletriptan versus sumatriptan at 2 h (67% vs. 57%; P < 0.0001) and 1 h (34% vs. 26%; P < 0.0001). Eletriptan also had higher 2 h pain-free (35% vs. 25%; P < 0.0001) and functional responses (67% vs. 58%; P < 0.0001). Sustained headache (42%) and pain-free (22%) response rates were higher for eletriptan versus sumatriptan (34%, P < 0.0001; 15%, P < 0.0001). The probability of response for eletriptan versus sumatriptan ranged from 36% higher (relief of nausea) to 64% higher (sustained pain-free rate). Combined analysis demonstrates that E40 has superior efficacy versus S100 across all clinically relevant outcomes. [source] Migraine Education Improves Quality of Life in a Primary Care SettingHEADACHE, Issue 4 2010Timothy R. Smith MD (Headache 2010;50:600-612) Objective., The objective of this study was to evaluate the effectiveness of the Mercy Migraine Management Program (MMMP), an educational program for physicians and patients. The primary outcome was change in headache days from baseline at 3, 6, and 12 months. Secondary outcomes were changes in migraine-related disability and quality of life, worry about headaches, self-efficacy for managing migraines, emergency room (ER) visits for headache, and satisfaction with headache care. Background., Despite progress in the understanding of the pathophysiology of migraine and development of effective therapeutic agents, many practitioners and patients continue to lack the knowledge and skills to effectively manage migraine. Educational efforts have been helpful in improving the quality of care and quality of life for migraine sufferers. However, little work has been performed to evaluate these changes over a longer period of time. Also, there is a paucity of published research evaluating the influence of education about migraine management on cognitive and emotional factors (for example, self-efficacy for managing headaches, worry about headaches). Methods., In this open-label, prospective study, 284 individuals with migraine (92% female, mean age = 41.6) participated in the MMMP, an educational and skills-based program. Of the 284 who participated in the program, 228 (80%) provided data about their headache frequency, headache-related disability (as measured by the Headache Impact Test-6 (HIT-6), migraine-specific quality of life (MSQ), worry about headaches, self-efficacy for managing headaches, ER visits for headaches, and satisfaction with care at 4 time points over 12 months (baseline, 3 months, 6 months, 12 months). Results., Overall, 46% (106) of subjects reported a 50% or greater reduction in headache frequency. Over 12 months, patients reported fewer headaches and improvement on the HIT-6 and MSQ (all P < .001). The improvement in headache impact and quality of life was greater among those who had more worry about their headaches at baseline. There were also significant improvements in "worry about headaches,""self-efficacy for managing headaches," and "satisfaction with headache care." Conclusion., The findings demonstrate that patients participating in the MMMP reported improvements in their headache frequency as well as the cognitive and emotional aspects of headache management. This program was especially helpful among those with high amounts of worry about their headaches at the beginning of the program. The findings from this study are impetus for further research that will more clearly evaluate the effects of education and skill development on headache characteristics and the emotional and cognitive factors that influence headache. [source] Revealing and Resolving Patient Safety Defects: The Impact of Leadership WalkRounds on Frontline Caregiver Assessments of Patient SafetyHEALTH SERVICES RESEARCH, Issue 6 2008Allan Frankel Objective. To evaluate the impact of rigorous WalkRounds on frontline caregiver assessments of safety climate, and to clarify the steps and implementation of rigorous WalkRounds. Data Sources/Study Setting. Primary outcome variables were baseline and post WalkRounds safety climate scores from the Safety Attitudes Questionnaire (SAQ). Secondary outcomes were safety issues elicited through WalkRounds. Study period was August 2002 to April 2005; seven hospitals in Massachusetts agreed to participate; and the project was implemented in all patient care areas. Study Design. Prospective study of the impact of rigorously applied WalkRounds on frontline caregivers assessments of safety climate in their patient care area. WalkRounds were conducted weekly and according to the seven-step WalkRounds Guide. The SAQ was administered at baseline and approximately 18 months post-WalkRounds implementation to all caregivers in patient care areas. Results. Two of seven hospitals complied with the rigorous WalkRounds approach; hospital A was an academic teaching center and hospital B a community teaching hospital. Of 21 patient care areas, SAQ surveys were received from 62 percent of respondents at baseline and 60 percent post WalkRounds. At baseline, 10 of 21 care areas (48 percent) had safety climate scores below 60 percent, whereas post-WalkRounds three care areas (14 percent) had safety climate scores below 60 percent without improving by 10 points or more. Safety climate scale scores in hospital A were 62 percent at baseline and 77 percent post-WalkRounds (t=2.67, p=.03), and in hospital B were 46 percent at baseline and 56 percent post WalkRounds (t=2.06, p=.06). Main safety issues by category were equipment/facility (A [26 percent] and B [33 percent]) and communication (A [24 percent] and B [18 percent]). Conclusions. WalkRounds implementation requires significant organizational will; sustainability requires outstanding project management and leadership engagement. In the patient care areas that rigorously implemented WalkRounds, frontline caregiver assessments of patient safety increased. SAQ results such as safety climate scores facilitate the triage of quality improvement efforts, and provide consensus assessments of frontline caregivers that identify themes for improvement. [source] The STRokE DOC trial technique: ,video clip, drip, and/or ship'INTERNATIONAL JOURNAL OF STROKE, Issue 4 2007B. C. Meyer Rationale To describe the clinical trial methods of a site-independent telemedicine system used in stroke. Aims A lack of readily available stroke expertise may partly explain the low rate of rt-PA use in acute stroke. Although telemedicine systems can reliably augment expertise available to rural settings, and may increase rt-PA use, point-to-point systems do require fixed base stations. Site-independent systems may minimize delay. The STRokE DOC trial assesses whether site-independent telemedicine effectively and efficiently brings rt-PA to a remote population. Design STRokE DOC is a 5-year, 400-participant, noninvasive trial, comparing two consultative techniques at four remote sites. Participants are randomized to acute ,STRokE DOC telemedicine' or ,telephone' consultations. Treatment decision accuracy is adjudicated at two time points, using three levels of data availability and an independent auditor. Study outcomes The primary outcome measure is whether there was a ,correct decision to treat or not to treat using rt-PA' at each of three adjudication levels (primarily at Level #2). Secondary outcomes include the number of thrombolytic recommendations, intracerebral hemorrhage, and 90-day outcomes. Using the STRokE DOC system (or telephone evaluation), medical history, neurologic scales, CT interpretations, and recommendations have been completed on over 200 participants to date. Of the initial 11, nonrandomized, ,run-in' patients, six (65%) were evaluated wirelessly, and five (45%) were evaluated with a site-independent LAN or cable modem. Three (27%) received rt-PA. The adjudication methodology was able to show both agreements and disagreements in these 11 cases. It is feasible to perform site-independent stroke consultations, and adjudicate those cases, using the STRokE DOC system and trial design. Telemedicine efficacy remains to be proven. [source] Promoting acute thrombolysis for ischaemic stroke (PRACTISE)INTERNATIONAL JOURNAL OF STROKE, Issue 2 2007Protocol for a cluster randomised controlled trial to assess the effect of implementation strategies on the rate, effects of thrombolysis for acute ischaemic stroke (ISRCTN 20405426) Rationale Thrombolysis with intravenous rtPA is an effective treatment for patients with ischaemic stroke if given within 3 h from onset. Generally, more than 20% of stroke patients arrive in time to be treated with thrombolysis. Nevertheless, in most hospitals, only 1,8% of all stroke patients are actually treated. Interorganisational, intraorganisational, medical and psychological barriers are hampering broad implementation of thrombolysis for acute ischaemic stroke. Aims To evaluate the effect of a high-intensity implementation strategy for intravenous thrombolysis in acute ischaemic stroke, compared with regular implementation; to identify success factors and obstacles for implementation and to assess its cost-effectiveness, taking into account the costs of implementation. Design The PRACTISE study is a national cluster-randomised-controlled trial. Twelve hospitals have been assigned to the regular or high-intensity intervention by random allocation after pair-wise matching. The high-intensity implementation consists of training sessions in conformity with the Breakthrough model, and a tool kit. All patients who are admitted with acute stroke and onset of symptoms not longer than 24 h are registered. Study outcomes The primary outcome measure is treatment with thrombolysis. Secondary outcomes are admission within 4 h after onset of symptoms, death or disability at 3 months, the rate of haemorrhagic complications in patients treated with thrombolysis, and costs of implementation and stroke care in the acute setting. Tertiary outcomes are derived from detailed criteria for the organisational characteristics, such as door-to-needle time and protocol violations. These can be used to monitor the implementation process and study the effectiveness of specific interventions. Discussion This study will provide important information on the effectiveness and cost-effectiveness of actively implementing an established treatment for acute ischaemic stroke. The multifaceted aspect of the intervention will make it difficult to attribute a difference in the primary outcome measure to a specific aspect of the intervention. However, careful monitoring of intermediate parameters as well as monitoring of accomplished SMART tasks can be expected to provide useful insights into the nature and role of factors associated with implementation of thrombolysis for acute ischaemic stroke, and of effective acute interventions in general. [source] Lack of Effect of Tai Chi Chuan in Preventing Falls in Elderly People Living at Home: A Randomized Clinical TrialJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 1 2009Inge H. J. Logghe MSc OBJECTIVES: To evaluate the effectiveness of Tai Chi Chuan in fall prevention in elderly people living at home with a high risk of falling. DESIGN: Randomized controlled trial. SETTING: Two industrial towns in the western part of the Netherlands. PARTICIPANTS: Two hundred sixty-nine elderly people (average age 77) living at home with a high risk of falling. INTERVENTIONS: The intervention group received Tai Chi Chuan training for 1 hour twice a week for 13 weeks; the control group received usual care. Both groups received a brochure containing general information on how to prevent fall incidents. MEASUREMENTS: Primary outcome was the number of falls over 12 months. Secondary outcomes were balance, fear of falling, blood pressure, heart rate at rest, forced expiratory volume during the first second, peak expiratory flow, physical activity, and functional status. RESULTS: After 12 months, no lower fall risk in the Tai Chi Chuan group was observed than in the control group (adjusted hazard ratio=1.16; 95% confidence interval=0.84,1.60), and there were no significant intervention effects on the secondary outcome measures. CONCLUSION: These results suggest that Tai Chi Chuan may not be effective in elderly people at a high risk of falling who live at home. [source] Effectiveness of a Falls-and-Fracture Nurse Coordinator to Reduce Falls: A Randomized, Controlled Trial of At-Risk Older AdultsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 8 2008(See editorial comments by Dr. Mary Tinetti on pp 156, 1565) OBJECTIVES: To assess the effectiveness of a community-based falls-and-fracture nurse coordinator and multifactorial intervention in reducing falls in older people. DESIGN: Randomized, controlled trial. SETTING: Screening for previous falls in family practice followed by community-based intervention. PARTICIPANTS: Three hundred twelve community-living people aged 75 and older who had fallen in the previous year. INTERVENTION: Home-based nurse assessment of falls-and-fracture risk factors and home hazards, referral to appropriate community interventions, and strength and balance exercise program. Control group received usual care and social visits. MEASUREMENTS: Primary outcome was rate of falls over 12 months. Secondary outcomes were muscle strength and balance, falls efficacy, activities of daily living, self-reported physical activity level, and quality of life (Medical Outcomes Study 36-item Short Form Questionnaire). RESULTS: Of the 3,434 older adults screened for falls, 312 (9%) from 19 family practices were enrolled and randomized. The average age was 81±5, and 69% (215/312) were women. The incidence rate ratio for falls for the intervention group compared with the control group was 0.96 (95% confidence interval=0.70,1.34). There were no significant differences in secondary outcomes between the two groups. CONCLUSION: This nurse-led intervention was not effective in reducing falls in older people who had fallen previously. Implementation and adherence to the fall-prevention measures was dependent on referral to other health professionals working in their usual clinical practice. This may have limited the effectiveness of the interventions. [source] Comparison of Effect of Aerobic Cycle Training and Progressive Resistance Training on Walking Ability After Stroke: A Randomized Sham Exercise,Controlled StudyJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 2008Mi-Joung Lee PhD OBJECTIVES: To determine whether changes in strength or cardiorespiratory fitness after exercise training improve walking ability in individuals who have had a stroke. DESIGN: A sham exercise-controlled, randomized two-by-two factorial design, in which the two factors investigated were cycle training (AEROBIC) and resistance training (STRENGTH). SETTING: University exercise laboratory. PARTICIPANTS: Fifty-two individuals with a history of stroke (aged 63±9; time since stroke, 57±54 months). INTERVENTION: Participants undertook 30 exercise sessions over 10 to 12 weeks. Depending on group allocation, individuals underwent aerobic cycling plus sham progressive resistance training (PRT) (n=13), sham cycling plus PRT (n=13), aerobic cycling plus PRT (n=14), or sham cycling plus sham PRT (n=12). MEASUREMENTS: Primary outcomes were 6-minute walk distance, habitual and fast gait velocities, and stair climbing power. Secondary outcomes included measures of cardiorespiratory fitness; muscle strength, power, and endurance; and psychosocial attributes. RESULTS: Neither AEROBIC nor STRENGTH improved walking distance or gait velocity significantly more than sham exercise, although STRENGTH significantly improved participants' stair climbing power by 17% (P=.009), as well as their muscle strength, power, and endurance; cycling peak power output; and self-efficacy. Conversely, AEROBIC improved indicators of cardiorespiratory fitness only. Cycling plus PRT produced larger effects than either single modality for mobility and impairment outcomes. CONCLUSION: Single-modality exercises targeted at existing impairments do not optimally address the functional deficits of walking but do ameliorate the underlying impairments. The underlying cardiovascular and musculoskeletal impairments are significantly modifiable years after stroke with targeted robust exercise. [source] Kenosha County Falls Prevention Study: A Randomized, Controlled Trial of an Intermediate-Intensity, Community-Based Multifactorial Falls InterventionJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 4 2007Jane E. Mahoney MD OBJECTIVES: To decrease the rate of falls in high-risk community-dwelling older adults. DESIGN: Randomized, controlled trial. SETTING: Community-based. PARTICIPANTS: Three hundred forty-nine adults aged 65 and older with two falls in the previous year or one fall in the previous 2 years with injury or balance problems. INTERVENTION: Subjects received two in-home visits from a trained nurse or physical therapist who assessed falls risk factors using an algorithm. The intervention consisted of recommendations to the subject and their primary physician, referrals to physical therapy and other providers, 11 monthly telephone calls, and a balance exercise plan. Control subjects received a home safety assessment. MEASUREMENTS: The primary outcome was rate of falls per year in the community. Secondary outcomes included all-cause hospitalizations and nursing home admissions per year. RESULTS: There was no difference in rate of falls between the intervention and control groups (rate ratio (RR)=0.81, P=.27). Nursing home days were fewer in the intervention group (10.3 vs 20.5 days, P=.04). Intervention subjects with a Mini-Mental State Examination (MMSE) score of 27 or less had a lower rate of falls (RR=0.55; P=.05) and, if they lived with someone, had fewer hospitalizations (RR=0.44, P=.05), nursing home admissions (RR=0.15, P=.003), and nursing home days (7.5 vs 58.2, P=.008). CONCLUSION: This multifactorial intervention did not decrease falls in at-risk community-living adults but did decrease nursing home utilization. There was evidence of efficacy in the subgroup who had an MMSE score of 27 or less and lived with a caregiver, but validation is required. [source] Treatment of Uncorrected Refractive Error Improves Vision-Specific Quality of LifeJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 2006Anne L. Coleman MD OBJECTIVES: To evaluate the benefit of eyeglasses and magnifiers in elderly patients with uncorrected refractive errors. DESIGN: A single-center, randomized, prospective, controlled trial (September 2001 to August 2003). SETTING: Los Angeles County, California. PARTICIPANTS: One hundred thirty-one community-dwelling persons aged 65 and older who had habitual distance visual acuity of 20/32 or worse and whose distant visual acuity, near visual acuity, or both could be improved with eyeglasses, a magnifier, or both by two lines of acuity or more. INTERVENTION: Sixty-six were randomized to receive a prescription and voucher for free eyeglasses, a magnifier, or both immediately, and 65 were randomized to receive a prescription and voucher after the 3-month follow-up visit (the control group). MEASUREMENTS: Primary outcome was vision-specific functioning as measured using the 25-item National Eye Institute,Visual Functioning Questionnaire (NEI-VFQ). Secondary outcomes were distance and near visual acuity and overall functioning as measured using the Rosow-Breslau function questionnaire. RESULTS: In the intention-to-treat analysis of 3-month follow-up data, participants who received the eyeglasses prescription and voucher immediately had greater improvement in NEI-VFQ composite scores than the control group (P<.01). They also had greater improvement in perceptions of their general vision (P<.01), distance visual acuity (P=.03), near visual acuity (P=.04), and mental health (P=.02). CONCLUSION: Correction of uncorrected refractive error, one of the leading causes of visual impairment in older people, improved the vision-specific quality of life of community-dwelling older persons. [source] Haloperidol Prophylaxis for Elderly Hip-Surgery Patients at Risk for Delirium: A Randomized Placebo-Controlled StudyJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 10 2005Kees J. Kalisvaart MD Objectives: To study the effectiveness of haloperidol prophylaxis on incidence, severity, and duration of postoperative delirium in elderly hip-surgery patients at risk for delirium. Design: Randomized, double-blind, placebo-controlled trial. Setting: Large medical school,affiliated general hospital in Alkmaar, the Netherlands. Participants: A total of 430 hip-surgery patients aged 70 and older at risk for postoperative delirium. Intervention: Haloperidol 1.5 mg/d or placebo was started preoperatively and continued for up to 3 days postoperatively. Proactive geriatric consultation was provided for all randomized patients. Measurements: The primary outcome was the incidence of postoperative delirium (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and Confusion Assessment Method criteria). Secondary outcomes were the severity of delirium (Delirium Rating Scale, revised version-98 (DRS-R-98)), the duration of delirium, and the length of hospital stay. Results: The overall incidence of postoperative delirium was 15.8%. The percentage of patients with postoperative delirium in the haloperidol and placebo treatment condition was 15.1% and 16.5%, respectively (relative risk=0.91, 95% confidence interval (CI)=0.6,1.3); the mean highest DRS-R-98 score±standard deviation was 14.4±3.4 and 18.4±4.3, respectively (mean difference 4.0, 95% CI=2.0,5.8; P<.001); delirium duration was 5.4 versus 11.8 days, respectively (mean difference 6.4 days, 95% CI=4.0,8.0; P<.001); and the mean number of days in the hospital was 17.1±11.1 and 22.6±16.7, respectively (mean difference 5.5 days, 95% CI=1.4,2.3; P<.001). No haloperidol-related side effects were noted. Conclusion: Low-dose haloperidol prophylactic treatment demonstrated no efficacy in reducing the incidence of postoperative delirium. It did have a positive effect on the severity and duration of delirium. Moreover, haloperidol reduced the number of days patients stayed in the hospital, and the therapy was well tolerated. [source] The Effect of Changing Practice on Fall Prevention in a Rehabilitative Hospital: The Hospital Injury Prevention StudyJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 3 2004Michael Vassallo FRCP Objectives: To determine whether a change in practice to introduce a multidisciplinary fall-prevention program can reduce falls and injury in nonacute patients in a rehabilitation hospital. Design: A quasi-experimental study. Setting: Three geriatric wards with a similar design, equipment, staffing levels, and skill mix. Participants: Eight hundred twenty-five consecutive patients. Intervention: The patients' fall-risk status was assessed using the Downton Score. Current practice was maintained on the two control wards (n=550). On the experimental ward (n=275), a fall-prevention program was introduced. A multidisciplinary team met weekly specifically to discuss patients' fall risk and formulate a targeted plan. Patients at risk were identified using wristbands; risk factors were corrected or environmental changes made to enhance safety. Measurements: Primary outcomes were number of fallers, recurrent fallers, total falls, patients sustaining injury, and falls per occupied bed days. Secondary outcomes were place of discharge and mortality. Results: Patients were matched for age and risk status. Control wards had proportionally more fallers (20.2% vs 14.2%: P=.033), patients sustaining injury (8.2% vs 4%: P=.025), and total number of falls (170 vs 72: P=.045). These results did not remain significant after controlling for differing length of stay. There was no reduction in recurrent fallers (6.4% vs 4.7%: P=.43) and no effect on place of discharge (home discharges; 57.5% vs 60.7%: P=.41) or mortality (15.3% vs 13.8%: P=.60). Conclusion: This study shows that falls might be reduced in a multidisciplinary fall-prevention program, but the results are not definitive because of the borderline significance achieved and the variable length of stay. More research on fall prevention in hospital is required, particularly as to what interventions, if any, are effective at reducing falls in this group of patients. [source] Effect of an interactive computerized psycho-education system on patients suffering from depressionJOURNAL OF CLINICAL NURSING, Issue 5 2008MPsychN, Mei-Feng Lin PhD Aims., The aim of this study was to examine the effect of an Interactive Computerized Psycho-Education System on patients suffering from depression and to compare the use of an Interactive Computerized Psycho-Education System vs. traditional pamphlet education approach. Background., Depression management depends on pharmacological treatment and psychotherapy and on appropriate and timely patient education. Whilst multimedia learning concepts have been applied in areas such as education, this approach has not been widely used in psychiatric outpatient departments. Design and method., A preliminary pre and post quasi-experimental design with patients with depression was employed at an hospital. Participants in the experimental group (n = 19) received an Interactive Computerized Psycho-Education System intervention programme (Interactive Computerized Psycho-Education System and the educational manual). Participants in the control group (n = 13) were exposed only to the traditional pamphlet education approach (consultation from psychiatrists and information sheets). Primary outcome was depression knowledge scores. Secondary outcomes were scores on the Compliance Behaviour Assessment Scale. Results., In the experimental group (n = 19), the time spent working on the Interactive Computerized Psycho-Education System was about 30,180 minutes per session, with an average of 67 minutes. Participants in the experimental group had a considerably decreased incidence of medication non-compliance compared with participants in the control group. Knowledge scores of the experimental group ranged from 30,100, with an average score of 74.7. Conclusion., The Interactive Computerized Psycho-Education System is acceptable and may be as more effective than a traditional education approach to achieve adherence to medications for depression. Relevance to clinical practice., Compared with a traditional approach, the combination of the Interactive Computerized Psycho-Education System and a nursing-consulting clinic may assist patients with depression to achieve and maintain better medication compliance in addition to improving their knowledge of depression. [source] A randomized controlled trial of a community nurse-supported hospital discharge programme in older patients with chronic heart failureJOURNAL OF CLINICAL NURSING, Issue 1 2008Timothy Kwok MD Aims and objectives., To evaluate the effectiveness and cost-effectiveness of a community nurse-supported hospital discharge programme in preventing hospital re-admissions, improving functional status and handicap of older patients with chronic heart failure. Design., Randomized controlled trial; 105 hospitalized patients aged 60 years or over with chronic heart failure and history of hospital admission(s) in previous year were randomly assigned into intervention group (n = 49) and control group (n = 56) for six months. Intervention group subjects received community nurse visits before discharge, within seven days of discharge, weekly for four weeks, then monthly. Community nurse liaised closely with a designated specialist in hospital and were accessible to subjects during normal working hours. Control and intervention group subjects were followed up in the same specialist medical clinics. Primary outcome was the rate of unplanned re-admission at six months. Secondary outcomes were number of unplanned re-admissions, six-minute walking distance, London Handicap Scale and public health care and personal care costs. Results., At sixth months, the re-admission rates were not significantly different (46 vs. 57% in control subjects, p = 0·233, Chi-square test). But the median number of re-admissions tended to lower in the intervention group (0 vs. 1 in control group, p = 0·057, Mann Whitney test). Intervention group subjects had less handicap in independence (median change 0 vs. 0·5 in control subjects, p = 0·002, Mann Whitney test), but there was no difference in six-minute walking distance. There was no significant group difference in median total public health care and personal care costs. Conclusion., Community nurse-supported post-discharge programme was effective in preserving independence and was probably effective in reducing the number of unplanned re-admissions. The cost benefits to public health care were not significant. Relevance to clinical practice., Older chronic heart failure patients are likely to benefit from post-discharge community nurse intervention programmes. More comprehensive health economic evaluation needs to be undertaken. [source] N -Acetylcysteine Added to Volume Expansion with Sodium Bicarbonate Does Not Further Prevent Contrast-Induced Nephropathy: Results from the Cardiac Angiography in Renally Impaired Patients StudyJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 3 2009CEZAR S. STANILOAE M.D. We reviewed data from the multicenter CARE (Cardiac Angiography in Renally Impaired Patients) study to see if benefit could be shown for N-acetylcysteine (NAC) in patients undergoing cardiac angiography who all received intravenous bicarbonate fluid expansion. Four hundred fourteen patients with moderate-to-severe chronic kidney disease were randomized to receive intra-arterial administration of iopamidol-370 or iodixanol-320. All patients were prehydrated with isotonic sodium bicarbonate solution. Each site chose whether or not to administer NAC 1,200 mg twice daily to all patients. Serum creatinine (SCr) levels and estimated glomerular filtration rate were assessed at baseline and 2,5 days after receiving contrast. The primary outcome was a postdose SCr increase 0.5 mg/dL (44.2 ,mol/L) over baseline. Secondary outcomes were a postdose SCr increase 25% and the mean peak change in SCr. The NAC group received significantly less hydration (892 ± 236 mL vs. 1016 ± 328 mL; P < 0.001) and more contrast volume (146 ± 74 mL vs. 127 ± 71 mL; P = 0.009) compared with no-NAC group. SCr increases 0.5 mg/dL occurred in 4.2% (7 of 168 patients) in NAC group and 6.5% (16 of 246 patients) in no-NAC group (P = 0.38); rates of SCr increases 25% were 11.9% and 10.6%, respectively (P = 0.75); mean post-SCr increases were 0.07 mg/dL in NAC group versus 0.11 mg/dL in no-NAC group (P = 0.14). In conclusion, addition of NAC to fluid expansion with sodium bicarbonate failed to reduce the rate of contrast-induced nephropathy (CIN) after the intra-arterial administration of iopamidol or iodixanol to high-risk patients with chronic kidney disease. [source] The performance of a novel ball-tipped Flush knife for endoscopic submucosal dissection: a case,control studyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2010T. Toyonaga Aliment Pharmacol Ther 2010; 32: 908,915 Summary Background, Endoscopic submucosal dissection (ESD) using short needle knives is safe and effective, but bleeding is a problem due to low haemostatic capability. Aim, To assess the performance of a novel ball-tipped needle knife (Flush knife-BT) for ESD with particular emphasis on haemostasis. Methods, A case,control study to compare the performance for ESD of 30 pairs of consecutive early gastrointestinal lesions (oesophagus: 12, stomach: 32, colorectum: 16) with standard Flush knife (F) vs. Flush knife-BT (BT). Primary outcome was efficacy of intraprocedure haemostasis. Secondary outcomes included procedure time, procedure speed (dividing procedure time into the area of resected specimen), en bloc resection rate and recurrence rate. Results, Median intraoperative bleeding points and bleeding points requiring haemostatic forceps were smaller in the BT group than in the F group (4 vs. 8, P < 0.0001, 0 vs. 3, P < 0.0001). There was no difference between groups for procedure time; however, procedure speed was shorter in the BT group (P = 0.0078). En bloc and en bloc R0 resection rates were 100%, with no perforation or post-operative bleeding. No recurrence was observed in either group at follow-up 1 year postprocedure. Conclusions, Ball-tipped Flush knife (Flush knife-BT) appears to improve haemostatic efficacy and dissection speed compared with standard Flush knife. [source] Clinical trial: the impact of cyclooxygenase inhibitors on gastrointestinal recovery after major surgery , a randomized double blind controlled trial of celecoxib or diclofenac vs. placeboALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2009D. A. WATTCHOW Summary Background, Ileus occurs after abdominal surgery and may be severe. Inhibition of prostaglandin release reduces post-operative ileus in a rat model. Aim, To determine whether prostaglandin inhibition by cyclooxygenase inhibitors, celecoxib or diclofenac, could enhance gastrointestinal recovery and reduce post-operative ileus in humans. Methods, Two hundred and ten patients undergoing elective major abdominal surgery were randomized to receive twice daily placebo (n = 67), celecoxib (100 mg, n = 74) or diclofenac (50 mg, n = 69), preoperatively and continuing for up to 7 days. Primary outcomes were hallmarks of gut recovery. Secondary outcomes were paralytic ileus, pain and complications. Results, There was no clinically significant difference between the groups for restoration of bowel function. There was a significant reduction in paralytic ileus in the celecoxib-treated group (n = 1, 1%) compared with diclofenac (n = 7, 10%) and placebo (n = 9, 13%); P = 0.025, RR 0.20, CI 0.01,0.77. Pain scores, analgesia, transfusion requirements and adverse event rates were similar between study groups. Conclusions, Perioperative low dose celecoxib, but not diclofenac, markedly reduced the development of paralytic ileus following major abdominal surgery, but did not accelerate early recovery of bowel function. This was independent of narcotic use and had no increase in post-operative complications. [source] Lamivudine prevents reactivation of hepatitis B and reduces mortality in immunosuppressed patients: systematic review and meta-analysisJOURNAL OF VIRAL HEPATITIS, Issue 2 2008L. H. Katz Summary., To assess the effects of prophylactic lamivudine on reactivation and mortality following immunosuppressive therapy in hepatitis B surface antigen (HBsAg)-positive patients, we performed a meta-analysis. Systematic review and meta-analysis of randomized and nonrandomized prospective controlled trials and retrospective comparative case series were identified through The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and LILACS. The primary outcomes were virological reactivation, clinical reactivation and mortality. Secondary outcomes included hepatitis B virus (HBV)-related mortality, liver histology, discontinuation or disruption of immunosuppressive therapy, lamivudine-resistant HBV strains and adverse events. A total of 21 studies were included, two of which were randomized controlled trials. Clinical and virological reactivation were significantly reduced in the lamivudine group [odds ratio (OR) 0.09; 95% confidence interval (CI) 0.05,0.15 and OR 0.04; 95% CI 0.01,0.14 respectively]. All-cause mortality was significantly reduced in the lamivudine group (OR 0.36; 95% CI 0.23,0.56) which translates to only 11 patients who need to be treated to prevent one death. Lamivudine significantly reduced HBV-related mortality, and discontinuations or disruptions of the immunosuppressive treatment. No adverse effects of lamivudine were recorded, and resistance to lamivudine occurred in low rates. We demonstrated a clear benefit of lamivudine in terms of clinical and virological HBV reactivation, overall mortality, HBV-related mortality and interruptions or discontinuations in the immunosuppressive treatment. Lamivudine should be administered prophylactically to HBsAg-positive patients who are about to receive immunosuppressive therapy. [source] Desloratadine relieves nasal congestion and improves quality-of-life in persistent allergic rhinitisALLERGY, Issue 11 2009K. Holmberg Background:, Symptoms of allergic rhinitis (AR), particularly nasal congestion, can impair quality-of-life (QoL). However, only a modest correlation exists between these symptoms and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores, suggesting that both be evaluated for a complete assessment of health. Methods:, Subjects with a ,2-year history of moderate-to-severe AR to dust mite or cat dander were randomized to desloratadine 5 mg/day (n = 293) or placebo/day (n = 291) for 28 days. Primary endpoint was change from baseline in a.m./p.m. nasal congestion score. Secondary outcomes included change from baseline in total nasal symptom score, individual symptom scores and RQLQ scores (completed on days 1, 7, and 28). Results:, The Allergic Rhinitis and its Impact on Asthma criteria for persistent allergic rhinitis (PER) were fulfilled by 99% of subjects in the placebo arm. Between-treatment difference in a.m./p.m. nasal congestion score, observed from day 8 onward, significantly favored desloratadine (P = 0.0003). Desloratadine significantly improved a.m./p.m. nasal congestion and RQLQ scores after 1 week and at treatment end (P < 0.05). Improvements in 5 of 7 RQLQ domain scores exceeded the minimal important difference. On days 7 and 28, desloratadine was also significantly superior to placebo in mean change from baseline in a.m./p.m. total nasal symptom score and rhinorrhea score (both P , 0.01). Symptomatic benefit was primarily driven by improvement in nasal congestion and rhinorrhea. Conclusions:, Desloratadine 5 mg/day significantly improved symptoms associated with PER, including nasal congestion, and provided significant improvement in QoL after 1 week of treatment. [source] Regular vs prn nebulized treatment in wheeze preschool childrenALLERGY, Issue 10 2009A. Papi Background:, International guidelines recommend regular treatment with inhaled glucocorticoids for children with frequent wheezing; however, prn inhaled bronchodilator alone or in combination with glucocorticoid is also often used in practice. We aimed to evaluate whether regular nebulized glucocorticoid plus a prn bronchodilator or a prn nebulized bronchodilator/glucocorticoid combination is more effective than prn bronchodilator alone in preschool children with frequent wheeze. Methods:, Double-blind, double-dummy, randomized, parallel-group trial. After a 2-week run-in period, 276 symptomatic children with frequent wheeze, aged 1,4 years, were randomly assigned to three groups for a 3-month nebulized treatment: (1) 400 ,g beclomethasone bid plus 2500 ,g salbutamol prn; (2) placebo bid plus 800 ,g beclomethasone/1600 ,g salbutamol combination prn; (3) placebo bid plus 2500 ,g salbutamol prn. The percentage of symptom-free days was the primary outcome measure. Secondary outcomes included symptom scores, use of relief medication and exacerbation frequency. Results:, As compared with prn salbutamol (61.0 ± 24.83 [SD]), the percentage of symptom-free days was higher with regular beclomethasone (69.6%, SD 20.89; P = 0.034) but not with prn combination (64.9%, SD 24.74). Results were no different in children with or without risk factors for developing persistent asthma. The effect of prn combination was no different from that of regular beclomethasone on the primary and on several important secondary outcomes. Conclusions:, Regular inhaled glucocorticoid is the most effective treatment for frequent wheezing in preschool children. However, prn bronchodilator/glucocorticoid combination might be an alternative option, but it requires further study. [source] Long-term results of a multicenter study on subthalamic and pallidal stimulation in Parkinson's disease,MOVEMENT DISORDERS, Issue 5 2010Elena Moro MD Abstract We report the 5 to 6 year follow-up of a multicenter study of bilateral subthalamic nucleus (STN) and globus pallidus internus (GPi) deep brain stimulation (DBS) in advanced Parkinson's disease (PD) patients. Thirty-five STN patients and 16 GPi patients were assessed at 5 to 6 years after DBS surgery. Primary outcome measure was the stimulation effect on the motor Unified Parkinson's Disease Rating Scale (UPDRS) assessed with a prospective cross-over double-blind assessment without medications (stimulation was randomly switched on or off). Secondary outcomes were motor UPDRS changes with unblinded assessments in off- and on-medication states with and without stimulation, activities of daily living (ADL), anti-PD medications, and dyskinesias. In double-blind assessment, both STN and GPi DBS were significantly effective in improving the motor UPDRS scores (STN, P < 0.0001, 45.4%; GPi, P = 0.008, 20.0%) compared with off-stimulation, regardless of the sequence of stimulation. In open assessment, both STN- and GPi-DBS significantly improved the off-medication motor UPDRS when compared with before surgery (STN, P < 0.001, 50.5%; GPi, P = 0.002, 35.6%). Dyskinesias and ADL were significantly improved in both groups. Anti-PD medications were significantly reduced only in the STN group. Adverse events were more frequent in the STN group. These results confirm the long-term efficacy of STN and GPi DBS in advanced PD. Although the surgical targets were not randomized, there was a trend to a better outcome of motor signs in the STN-DBS patients and fewer adverse events in the GPi-DBS group. © 2010 Movement Disorder Society [source] | ||||||||||||||||||||||||||||||||||||||||