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Circulation. Cardiovascular Quality and... Oct 2015About half of survivors with stroke experience severe and significant long-term disability. The purpose of this article is to review the state of the science and to make... (Review)
Review
BACKGROUND
About half of survivors with stroke experience severe and significant long-term disability. The purpose of this article is to review the state of the science and to make recommendations for measuring patient-centric outcomes in interventions for motor improvement in the chronic stroke phase.
METHODS AND RESULTS
A 9-member expert panel reviewed evidence to identify measures of upper and lower extremity function used to date as outcomes in trials with patients who experienced a stroke ≥6 months before assessment. Outcome measures were screened using StrokEDGE consensus panel recommendations, and evaluated for availability of a published minimal clinically important difference. Measures meeting these criteria were further evaluated with regard to their level of measurement, psychometric properties, and ability of minimal clinically important difference to capture gains associated with improved function and clinical relevance to patients, to arrive at recommendations. A systematic literature review yielded 115 clinical trials of upper and lower extremity function in chronic stroke that used a total of 34 outcome measures. Seven of these had published minimal clinically important differences and were recommended or highly recommended by StrokEDGE. Those are the Fugl-Meyer Upper Extremity and Lower Extremity scales, Wolf Motor Function Test, Action Research Arm Test, Ten-Meter and Six-Minute Walk Tests, and the Stroke Impact Scale. All had evidence for their psychometric performance, although the strength of evidence for validity varied, especially in populations with chronic stroke Fugl-Meyer Upper and Lower Extremity scales showing the strongest evidence for validity.
CONCLUSIONS
The panel recommends that the Fugl-Meyer Upper and Lower Extremity scales be used as primary outcomes in intervention trials targeting motor function in populations with chronic stroke. The other 6 measures are recommended as secondary outcomes.
Topics: Chronic Disease; Clinical Trials as Topic; Disability Evaluation; Early Medical Intervention; Expert Testimony; Humans; Lower Extremity; Outcome Assessment, Health Care; Recovery of Function; Research Design; Stroke; Upper Extremity
PubMed: 26515205
DOI: 10.1161/CIRCOUTCOMES.115.002098 -
British Journal of Haematology Aug 2015Many studies report estimated pulmonary artery systolic pressure (ePASP) in patients with sickle cell disease (SCD) screened by echocardiography. To better understand... (Meta-Analysis)
Meta-Analysis Review
Many studies report estimated pulmonary artery systolic pressure (ePASP) in patients with sickle cell disease (SCD) screened by echocardiography. To better understand the prevalence and outcomes of elevated ePASP in clinically stable SCD patients, we conducted a random-effects meta-analysis. A total of 45 studies, representing 15 countries and including 6109 individuals, met our inclusion criteria. In most (70%) studies, elevated ePASP was defined by a tricuspid regurgitant velocity of 2.5 m/s. The prevalence of elevated ePASP was 21% (17-26%) in children and 30% (26-35%) in adults. After adjustment for sex, SCD genotype, haemoglobin, hydroxycarbamide (hydroxyurea) treatment, country and publication year, age remained associated with elevated ePASP, yielding a 12% (0.4-23%) higher adjusted prevalence in adults. Few studies reported 6-min walk tests or mortality outcomes, and estimates were highly heterogeneous. In random effects meta-analyses, patients with elevated ePASP walked an estimated 30.4 (6.9-53.9) metres less than those without elevated ePASP and had an associated mortality hazard ratio of 4.9 (2.4-9.7).
Topics: Adult; Anemia, Sickle Cell; Antisickling Agents; Arterial Pressure; Echocardiography; Female; Humans; Hydroxyurea; Male; Prevalence; Pulmonary Artery
PubMed: 25854714
DOI: 10.1111/bjh.13447 -
The Cochrane Database of Systematic... Mar 2015Community ambulation refers to the ability of a person to walk in their own community, outside of their home and also indoors in private or public locations. Some people... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Community ambulation refers to the ability of a person to walk in their own community, outside of their home and also indoors in private or public locations. Some people choose to walk for exercise or leisure and may walk with others as an important aspect of social functioning. Community ambulation is therefore an important skill for stroke survivors living in the community whose walking ability has been affected.
OBJECTIVES
To determine: (1) whether interventions improve community ambulation for stroke survivors, and (2) if any specific intervention method improves community ambulation more than other interventions.
SEARCH METHODS
We searched the Cochrane Stroke Group Trials Register (September 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (November 2013), PubMed (1946 to November 2013), EMBASE (1980 to November 2013), CINAHL (1982 to November 2013), PsycINFO (1887 to November 2013), Scopus (1960 to November 2013), Web of Science (1900 to November 2013), SPORTDiscus (1975 to November 2013), and PEDro, CIRRIE and REHABDATA (November 2013). We also searched ongoing trials registers (November 2013) and reference lists, and performed a cited reference search.
SELECTION CRITERIA
Selection criteria included parallel-group randomised controlled trials (RCTs) and cross-over RCTs, studies in which participants are adult (aged 18 years or more) stroke survivors, and interventions that were aimed at improving community ambulation. We defined the primary outcome as participation; secondary outcomes included activity level outcomes related to gait and self-efficacy.
DATA COLLECTION AND ANALYSIS
One review author independently screened titles. Two review authors screened abstracts and full text articles, with a third review author was available to resolve any disagreements. Two review authors extracted data and assessed risk of bias. All outcomes were continuous. The analysis for the primary outcome used the generic inverse variance methods for meta-analysis, using the standardised mean difference (SMD) and standard error (SE) from the participation outcomes. Analyses for secondary outcomes all used SMD or mean difference (MD). We completed analyses for each outcome with all studies, and by type of community ambulation intervention (community or outdoor ambulation practice, virtual practice, and imagery practice). We considered trials for each outcome to be of low quality due to some trial design considerations, such as who knew what group the participants were in, and the number of people who dropped out of the studies.
MAIN RESULTS
We included five studies involving 266 participants (136 intervention; 130 control). All participants were adult stroke survivors, living in the community or a care home. Programmes to improve community ambulation consisted of walking practice in a variety of settings and environments in the community, or an indoor activity that mimicked community walking (including virtual reality or mental imagery). Three studies were funded by government agencies, and two had no funding.From two studies of 198 people there was low quality evidence for the effect of intervention on participation compared with control (SMD, 0.08, 95% confidence interval (CI) -0.20 to 0.35 (using inverse variance). The CI for the effect of the intervention on gait speed was wide and does not exclude no difference (MD 0.12, 95% CI -0.01 to 0.24; four studies, 98 participants, low quality evidence). We considered the quality of the evidence to be low for all the remaining outcomes in our review: Community Walk Test (MD -6.35, 95% CI -21.59 to 8.88); Walking Ability Questionnaire (MD 0.53, 95% CI -5.59 to 6.66); Six-Minute Walk Test (MD 39.62 metres, 95% CI -8.26 to 87.51) and self-efficacy (SMD 0.32, 95% CI -0.09 to 0.72). We downgraded the quality of the evidence because of a high risk of bias and imprecision.
AUTHORS' CONCLUSIONS
There is currently insufficient evidence to establish the effect of community ambulation interventions or to support a change in clinical practice. More research is needed to determine if practicing outdoor or community walking will improve participation and community ambulation skills for stroke survivors living in the community.
Topics: Activities of Daily Living; Adult; Environment Design; Gait; Humans; Randomized Controlled Trials as Topic; Residence Characteristics; Self Efficacy; Stroke Rehabilitation; Time Factors; Walking
PubMed: 25767912
DOI: 10.1002/14651858.CD010200.pub2 -
Pulmonary Medicine 2014Little is known about the effect of pulmonary arterial hypertension (PAH) specific therapy on pulmonary hemodynamics and exercise capacity in patients with... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Little is known about the effect of pulmonary arterial hypertension (PAH) specific therapy on pulmonary hemodynamics and exercise capacity in patients with portopulmonary hypertension (PoPH) because such patients are usually excluded from randomized clinical trials (RCT) of such therapy.
METHODS
We searched PUBMED using the terms "(Therapy/Broad (filter)) AND (portopulmonary hypertension)." We included studies that met the following criteria: ≥5 patients, AND PoPH confirmed by right heart catheterization (RHC), AND follow-up RHC data, AND/OR baseline and follow-up 6MWD available.
RESULTS
12 studies met our inclusion criteria. None was a RCT. The baseline mPAP was 48.6 ± 4.4 mmHg, cardiac output (CO) 5.6 ± 0.9 L/min, and pulmonary vascular resistance (PVR) 668.6 ± 219.1 dynes.sec/cm(5). The baseline 6MWD was 348.2 ± 35.6 meters. The use of PAH specific therapy improved mPAP by 7.54 mmHg (95% CI 10.2 to 4.9), CO by 1.77 L/min (95% CI 1.1 to 2.4), and PVR by 253 dynes.sec/cm(5) (95% CI 291.4 to 214.6) (n = 135) and 6MWD by 61.8 meters (95% CI 47.5 to 76) (n = 122).
CONCLUSIONS
The use of PAH specific therapy in PoPH results in significant improvement in both pulmonary hemodynamics and 6MWD.
Topics: Female; Hemodynamics; Humans; Hypertension, Portal; Hypertension, Pulmonary; Lung; Male; Middle Aged; Physical Endurance; Walking
PubMed: 25478223
DOI: 10.1155/2014/528783 -
Sleep Feb 2015The relationship between nasal surgery and its effect on continuous positive airway pressure (CPAP) device therapeutic treatment pressures and CPAP device use has not... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The relationship between nasal surgery and its effect on continuous positive airway pressure (CPAP) device therapeutic treatment pressures and CPAP device use has not been previously systematically examined.
STUDY OBJECTIVES
To conduct a systematic review and meta-analysis evaluating the effect of isolated nasal surgery on therapeutic CPAP device pressures and use in adults with obstructive sleep apnea (OSA).
METHODS
MEDLINE, Scopus, Web of Science, and The Cochrane Library were searched through July 15, 2014. The MOOSE consensus statement and PRISMA statement were followed.
RESULTS
Eighteen studies (279 patients) reported CPAP data after isolated nasal surgery. Seven studies (82 patients) reported preoperative and postoperative mean therapeutic CPAP device pressures and standard deviations (SD), which reduced from 11.6 ± 2.2 to 9.5 ± 2.0 centimeters of water pressure (cwp) after nasal surgery. Pooled random effects analysis demonstrated a statistically significant pressure reduction, with a mean difference (MD) of -2.66 cwp (95% confidence interval (CI), -3.65 to -1.67); P < 0.00001. Eleven studies (153 patients) reported subjective, self-reported data for CPAP use; and a subgroup analysis demonstrated that 89.1% (57 of 64 patients) who were not using CPAP prior to nasal surgery subsequently accepted, adhered to, or tolerated it after nasal surgery. Objective, device meter-based hours of use increased in 33 patients from 3.0 ± 3.1 to 5.5 ± 2.0 h in the short term (<6 mo of follow-up).
CONCLUSION
Isolated nasal surgery in patients with OSA and nasal obstruction reduces therapeutic CPAP device pressures and the currently published literature's objective and subjective data consistently suggest that it also increases CPAP use in select patients.
Topics: Continuous Positive Airway Pressure; Humans; Nasal Surgical Procedures; Postoperative Period; Preoperative Period; Pressure; Sleep Apnea, Obstructive; Treatment Outcome
PubMed: 25325439
DOI: 10.5665/sleep.4414 -
Journal of the American Heart... Aug 2014Peripheral artery disease (PAD) is associated with impaired mobility and a high rate of mortality. The aim of this systematic review was to investigate whether reduced... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Peripheral artery disease (PAD) is associated with impaired mobility and a high rate of mortality. The aim of this systematic review was to investigate whether reduced lower extremity performance was associated with an increased incidence of cardiovascular and all-cause mortality in people with PAD.
METHODS AND RESULTS
A systematic search of the MEDLINE, EMBASE, SCOPUS, Web of Science, and Cochrane Library databases was conducted. Studies assessing the association between measures of lower extremity performance and cardiovascular or all-cause mortality in PAD patients were included. A meta-analysis was conducted combining data from commonly assessed performance tests. The 10 identified studies assessed lower extremity performance by strength tests, treadmill walking performance, 6-minute walk, walking velocity, and walking impairment questionnaire (WIQ). A meta-analysis revealed that shorter maximum walking distance was associated with increased 5-year cardiovascular (unadjusted RR=2.54, 95% CI 1.86 to 3.47, P<10(-5), n=1577, fixed effects) and all-cause mortality (unadjusted RR=2.23 95% CI 1.85 to 2.69, P<10(-5), n=1710, fixed effects). Slower 4-metre walking velocity, a lower WIQ stair-climbing score, and poor hip extension, knee flexion, and plantar flexion strength were also associated with increased mortality. No significant associations were found for hip flexion strength, WIQ distance score, or WIQ speed score with mortality.
CONCLUSIONS
A number of lower extremity performance measures are prognostic markers for mortality in PAD and may be useful clinical tools for identifying patients at higher risk of death. Further studies are needed to determine whether interventions that improve measures of lower extremity performance reduce mortality.
Topics: Cardiovascular Diseases; Exercise Test; Humans; Lower Extremity; Mortality; Peripheral Arterial Disease; Prognosis; Walking
PubMed: 25122666
DOI: 10.1161/JAHA.114.001105 -
PloS One 2014This systematic review evaluated the effects of Chinese herbal medicine (CHM) plus routine pharmacotherapy (RP) on the objective outcome measures BODE index, 6-minute... (Review)
Review
This systematic review evaluated the effects of Chinese herbal medicine (CHM) plus routine pharmacotherapy (RP) on the objective outcome measures BODE index, 6-minute walk test (6MWT), and 6-minute walk distance (6MWD) in individuals with stable chronic obstructive pulmonary disease (COPD). Searches were conducted of six English and Chinese databases (PubMed, EMBASE, CENTRAL, CINAHL, CNKI and CQVIP) from their inceptions until 18th November 2013 for randomized controlled trials involving oral administration of CHM plus RP compared to the same RP, with BODE Index and/or 6MWT/D as outcomes. Twenty-five studies were identified. BODE Index was used in nine studies and 6MWT/D was used in 22 studies. Methodological quality was assessed using the Cochrane Risk of Bias tool. Weaknesses were identified in most studies. Six studies were judged as 'low' risk of bias for randomisation sequence generation. Twenty-two studies involving 1,834 participants were included in the meta-analyses. The main meta-analysis results showed relative benefits for BODE Index in nine studies (mean difference [MD] -0.71, 95% confidence interval [CI] -0.94, -0.47) and 6MWT/D in 17 studies (MD 54.61 meters, 95%CI 33.30, 75.92) in favour of the CHM plus RP groups. The principal plants used were Astragalus membranaceus, Panax ginseng and Cordyceps sinensis. A. membranaceus was used in combination with other herbs in 18 formulae in 16 studies. Detailed sub-group and sensitivity analyses were conducted. Clinically meaningful benefits for BODE Index and 6MWT were found in multiple studies. These therapeutic effects were promising but need to be interpreted with caution due to variations in the CHMs and RPs used and methodological weakness in the studies. These issues should be addressed in future trials.
Topics: Administration, Oral; Drug Interactions; Drugs, Chinese Herbal; Exercise Test; Humans; Pulmonary Disease, Chronic Obstructive; Time Factors; Walking
PubMed: 24622390
DOI: 10.1371/journal.pone.0091830 -
Obesity Surgery Mar 2014We performed a meta-analysis of weight loss and remission of type 2 diabetes mellitus (T2DM) evaluated in randomized controlled trials (RCTs) and observational studies... (Meta-Analysis)
Meta-Analysis Review
We performed a meta-analysis of weight loss and remission of type 2 diabetes mellitus (T2DM) evaluated in randomized controlled trials (RCTs) and observational studies of bariatric surgery vs conventional medical therapy. English articles published through June 10, 2013 that compared bariatric surgery with conventional therapy and included T2DM endpoints with ≥12-month follow-up were systematically reviewed. Body mass index (BMI, in kilogram per square meter), glycated hemoglobin (HbA1C, in degree), and fasting plasma glucose (FPG, in milligram per deciliter) were analyzed by calculating weighted mean differences (WMDs) and pooled standardized mean differences and associated 95 % confidence intervals (95 % CI). Aggregated T2DM remission event data were analyzed by calculating the pooled odds ratio (POR) and 95 % CI. Random effects assumptions were applied throughout; I(2) ≥ 75.0 % was considered indicative of significant heterogeneity. Systematic review identified 512 articles: 47 duplicates were removed, 446 failed inclusion criteria (i.e., n < 10 per arm, animal studies, reviews, case reports, abstracts, and kin studies). Of 19 eligible articles, two not focused on diagnosed T2DM and one with insufficient T2DM data were excluded. In the final 16 included papers, 3,076 patients (mean BMI, 40.9; age, 47.0; 72.0 % female) underwent bariatric surgery; 3,055 (39.4; 48.6, 69.0 %) received conventional or no weight-loss therapy. In bariatric surgery vs conventional therapy groups, the mean 17.3 ± 5.7 month BMI WMD was 8.3 (7.0, 9.6; p < 0.001; I(2) = 91.8), HbA(1C) was 1.1 (0.6, 1.6; p < 0.001; I(2) = 91.9), and FPG, 24.9 (15.9, 33.9; p < 0.001; I(2) = 84.8), with significant differences favoring surgery. The overall T2DM remission rate for surgery vs conventional group was 63.5 vs 15.6 % (p < 0.001). The Peto summary POR was 9.8 (6.1, 15.9); inverse variance summary POR was 15.8 (7.9, 31.4). Of the included studies, 94.0 % demonstrated a significant statistical advantage favoring surgery. In a meta-analysis of 16 studies (5 RCTs) with 6,131 patients and mean 17.3-month follow-up, bariatric surgery was significantly more effective than conventional medical therapy in achieving weight loss, HbA(1C) and FPG reduction, and diabetes remission. The odds of bariatric surgery patients reaching T2DM remission ranged from 9.8 to 15.8 times the odds of patients treated with conventional therapy.
Topics: Bariatric Surgery; Blood Glucose; Diabetes Mellitus, Type 2; Fasting; Female; Glycated Hemoglobin; Humans; Male; Obesity, Morbid; Randomized Controlled Trials as Topic; Remission Induction; Weight Loss
PubMed: 24374842
DOI: 10.1007/s11695-013-1160-3 -
The Cochrane Database of Systematic... Jun 2013Nebulizers and metered dose inhalers (MDI) have both been adapted for delivering aerosol bronchodilation to mechanically ventilated patients, but there is incomplete... (Comparative Study)
Comparative Study Review
BACKGROUND
Nebulizers and metered dose inhalers (MDI) have both been adapted for delivering aerosol bronchodilation to mechanically ventilated patients, but there is incomplete knowledge as to the most effective method of delivery.
OBJECTIVES
To compare the effectiveness of nebulizers and MDIs for bronchodilator delivery in invasively ventilated, critically ill adults.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 5); Ovid MEDLINE (1950 to Week 19 2012); Ovid EMBASE (1980 to Week 19 2012); CINAHL via EBSCOhost (1982 to Week 19 2012) and reference lists of articles. We searched conference proceedings and reference lists of articles. We also contacted manufacturers and researchers in this field. There were no constraints based on language or publication status.
SELECTION CRITERIA
Randomized controlled trials (RCTs), including randomized cross-over trials where the order of the intervention was randomized, comparing the nebulizer and MDI for aerosol bronchodilation in mechanically ventilated adult patients in critical care units.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information where required. We collected information about adverse effects from the trials.
MAIN RESULTS
This review included three trials, two addressing the primary outcome measure of a reduction of airway resistance (measured as a reduction in interrupter and additional airway resistance) with a total of 28 patients (n =10, n =18) and two addressing adverse changes to haemodynamic observations with a total of 36 patients (n =18, n =18). Limitations in data availability and reporting in the included trials precluded meta-analysis and therefore the present review consisted of a descriptive analysis. Risk of bias in the included trials was judged as low or of unknown risk across the majority of items in the 'Risk of bias' tool.Cautious interpretation of the included study results suggests that nebulizers could be a more effective method of bronchodilator administration than MDI in terms of a change in resistance. No apparent changes to haemodynamic observations (measured as an increase in heart rate) were associated with either mode of delivery. Due to missing data issues, meta analyses were not possible. Additionally, small sample sizes and variability between the studies with regards to patient diagnoses, bronchodilator agent and administration technique mean that it would be speculative to infer definitive recommendations based on these results at this time. This is insufficient evidence to determine which is the most effective delivery system between nebuliser and MDI for aerosol bronchodilation in adult patients receiving mechanical ventilation.
AUTHORS' CONCLUSIONS
Existing randomized controlled trials, including randomized cross-over trials where the order of the intervention was randomized, comparing nebulizer and MDI for aerosol bronchodilation in mechanically ventilated adult patients do not provide sufficient evidence to support either delivery method at this time.
Topics: Adult; Aerosols; Airway Resistance; Bronchodilator Agents; Critical Illness; Heart Rate; Humans; Intensive Care Units; Metered Dose Inhalers; Nebulizers and Vaporizers; Randomized Controlled Trials as Topic; Respiration, Artificial
PubMed: 23740736
DOI: 10.1002/14651858.CD008863.pub2 -
Critical Care (London, England) Mar 2013Glucose control to prevent both hyperglycemia and hypoglycemia is important in an intensive care unit. Arterial blood gas analyzers and glucose meters are commonly used... (Review)
Review
INTRODUCTION
Glucose control to prevent both hyperglycemia and hypoglycemia is important in an intensive care unit. Arterial blood gas analyzers and glucose meters are commonly used to measure blood-glucose concentration in an intensive care unit; however, their accuracies are still unclear.
METHODS
We performed a systematic literature search (January 1, 2001, to August 31, 2012) to find clinical studies comparing blood-glucose values measured with glucose meters and/or arterial blood gas analyzers with those simultaneously measured with a central laboratory machine in critically ill adult patients.
RESULTS
We reviewed 879 articles and found 21 studies in which the accuracy of blood-glucose monitoring by arterial blood gas analyzers and/or glucometers by using central laboratory methods as references was assessed in critically ill adult patients. Of those 21 studies, 11 studies in which International Organization for Standardization criteria, error-grid method, or percentage of values within 20% of the error of a reference were used were selected for evaluation. The accuracy of blood-glucose measurements by arterial blood gas analyzers and glucose meters by using arterial blood was significantly higher than that of measurements with glucose meters by using capillary blood (odds ratios for error: 0.04, P<0.001; and 0.36, P<0.001). The accuracy of blood-glucose measurements with arterial blood gas analyzers tended to be higher than that of measurements with glucose meters by using arterial blood (P=0.20). In the hypoglycemic range (defined as <81 mg/dl), the incidence of errors using these devices was higher than that in the nonhypoglycemic range (odds ratios for error: arterial blood gas analyzers, 1.86, P=0.15; glucose meters with capillary blood, 1.84, P=0.03; glucose meters with arterial blood, 2.33, P=0.02). Unstable hemodynamics (edema and use of a vasopressor) and use of insulin were associated with increased error of blood glucose monitoring with glucose meters.
CONCLUSIONS
Our literature review showed that the accuracy of blood-glucose measurements with arterial blood gas analyzers was significantly higher than that of measurements with glucose meters by using capillary blood and tended to be higher than that of measurements with glucose meters by using arterial blood. These results should be interpreted with caution because of the large variation of accuracy among devices. Because blood-glucose monitoring was less accurate within or near the hypoglycemic range, especially in patients with unstable hemodynamics or receiving insulin infusion, we should be aware that current blood glucose-monitoring technology has not reached a high enough degree of accuracy and reliability to lead to appropriate glucose control in critically ill patients.
Topics: Blood Gas Analysis; Blood Glucose; Critical Illness; Humans; Monitoring, Physiologic
PubMed: 23506841
DOI: 10.1186/cc12567