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Brazilian Journal of Cardiovascular... 2016The aim of the study is to compare the available reference values and the six-minute walk test equations in healthy children/adolescents. Our systematic review was... (Review)
Review
OBJECTIVE
The aim of the study is to compare the available reference values and the six-minute walk test equations in healthy children/adolescents. Our systematic review was planned and performed in accordance with the PRISMA guidelines. We included all studies that established reference values for the six-minute walk test in healthy children/adolescents.
METHODS
To perform this review, a research was performed in PubMed, EMBASE (via SCOPUS) and Cochrane (LILACS), Bibliographic Index Spanish in Health Sciences, Organization Collection Pan-American Health Organization, Publications of the World Health Organization and Scientific Electronic Library Online (SciELO) via Virtual Health Library until June 2015 without language restriction.
RESULTS
The initial research identified 276 abstracts. Twelve studies met the inclusion criteria and were fully reviewed and approved by both reviewers. None of the selected studies presented sample size calculation. Most of the studies recruited children and adolescents from school. Six studies reported the use of random samples. Most studies used a corridor of 30 meters. All studies followed the American Thoracic Society guidelines to perform the six-minute walk test. The walked distance ranged 159 meters among the studies. Of the 12 included studies, 7 (58%) reported descriptive data and 6 (50%) established reference equation for the walked distance in the six-minute walk test.
CONCLUSION
The reference value for the six-minute walk test in children and adolescents ranged substantially from studies in different countries. A reference equation was not provided in all studies, but the ones available took into account well established variables in the context of exercise performance, such as height, heart rate, age and weight. Countries that did not established reference values for the six-minute walk test should be encouraged to do because it would help their clinicians and researchers have a more precise interpretation of the test.
Topics: Adolescent; Age Factors; Child; Child, Preschool; Exercise Tolerance; Female; Humans; Male; Reference Values; Walk Test
PubMed: 27982347
DOI: 10.5935/1678-9741.20160081 -
The Cochrane Database of Systematic... Oct 2016Serum monoclonal anti-myelin-associated glycoprotein (anti-MAG) antibodies may be pathogenic in some people with immunoglobulin M (IgM) paraprotein and demyelinating... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Serum monoclonal anti-myelin-associated glycoprotein (anti-MAG) antibodies may be pathogenic in some people with immunoglobulin M (IgM) paraprotein and demyelinating neuropathy. Immunotherapies aimed at reducing the level of these antibodies might be expected to be beneficial. This is an update of a review first published in 2003 and previously updated in 2006 and 2012.
OBJECTIVES
To assess the effects of immunotherapy for IgM anti-MAG paraprotein-associated demyelinating peripheral neuropathy.
SEARCH METHODS
On 1 February 2016 we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase for randomised controlled trials (RCTs). We also checked trials registers and bibliographies, and contacted authors and experts in the field.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) or quasi-RCTs involving participants of any age treated with any type of immunotherapy for anti-MAG antibody-associated demyelinating peripheral neuropathy with monoclonal gammopathy of undetermined significance and of any severity.Our primary outcome measures were numbers of participants improved in disability assessed with either or both of the Neuropathy Impairment Scale (NIS) or the modified Rankin Scale (mRS) at six months after randomisation. Secondary outcome measures were: mean improvement in disability, assessed with either the NIS or the mRS, 12 months after randomisation; change in impairment as measured by improvement in the 10-metre walk time, change in a validated linear disability measure such as the Rasch-built Overall Disability Scale (R-ODS) at six and 12 months after randomisation, change in subjective clinical scores and electrophysiological parameters at six and 12 months after randomisation; change in serum IgM paraprotein concentration or anti-MAG antibody titre at six months after randomisation; and adverse effects of treatments.
DATA COLLECTION AND ANALYSIS
We followed standard methodological procedures expected by Cochrane.
MAIN RESULTS
We identified eight eligible trials (236 participants), which tested intravenous immunoglobulin (IVIg), interferon alfa-2a, plasma exchange, cyclophosphamide and steroids, and rituximab. Two trials of IVIg (22 and 11 participants, including 20 with antibodies against MAG), had comparable interventions and outcomes, but both were short-term trials. We also included two trials of rituximab with comparable interventions and outcomes.There were very few clinical or statistically significant benefits of the treatments used on the outcomes predefined for this review, but not all the predefined outcomes were used in every included trial and more responsive outcomes are being developed. A well-performed trial of IVIg, which was at low risk of bias, showed a statistical benefit in terms of improvement in mRS at two weeks and 10-metre walk time at four weeks, but these short-term outcomes are of questionable clinical significance. Cyclophosphamide failed to show any benefit in the single trial's primary outcome, and showed a barely significant benefit in the primary outcome specified here, but some toxic adverse events were identified.Two trials of rituximab (80 participants) have been published, one of which (26 participants) was at high risk of bias. In the meta-analysis, although the data are of low quality, rituximab is beneficial in improving disability scales (Inflammatory Neuropathy Cause and Treatment (INCAT) improved at eight to 12 months (risk ratio (RR) 3.51, 95% confidence interval (CI) 1.30 to 9.45; 73 participants)) and significantly more participants improve in the global impression of change score (RR 1.86, 95% CI 1.27 to 2.71; 70 participants). Other measures did not improve significantly, but wide CIs do not preclude some effect. Reported adverse effects of rituximab were few, and mostly minor.There were few serious adverse events in the other trials.
AUTHORS' CONCLUSIONS
There is inadequate reliable evidence from trials of immunotherapies in anti-MAG paraproteinaemic neuropathy to form an evidence base supporting any particular immunotherapy treatment. IVIg has a statistically but probably not clinically significant benefit in the short term. The meta-analysis of two trials of rituximab provides, however, low-quality evidence of a benefit from this agent. The conclusions of this meta-analysis await confirmation, as one of the two included studies is of very low quality. We require large well-designed randomised trials of at least 12 months' duration to assess existing or novel therapies, preferably employing unified, consistent, well-designed, responsive, and valid outcome measures.
Topics: Demyelinating Diseases; Humans; Immunoglobulin M; Immunoglobulins, Intravenous; Immunosuppressive Agents; Immunotherapy; Myelin-Associated Glycoprotein; Paraproteinemias; Paraproteins; Peripheral Nervous System Diseases; Plasma Exchange; Randomized Controlled Trials as Topic; Rituximab
PubMed: 27701752
DOI: 10.1002/14651858.CD002827.pub4 -
BMC Pulmonary Medicine Oct 2016In many countries worldwide, the long-acting anticholinergic drug tiotropium is available as a dry powder formulation delivered by means of the HandiHaler® inhalation... (Review)
Review
A systematic review of comparative studies of tiotropium Respimat® and tiotropium HandiHaler® in patients with chronic obstructive pulmonary disease: does inhaler choice matter?
BACKGROUND
In many countries worldwide, the long-acting anticholinergic drug tiotropium is available as a dry powder formulation delivered by means of the HandiHaler® inhalation device and as an aqueous solution delivered via the Respimat® Soft Mist™ Inhaler. Tiotropium HandiHaler® is a single-dose, dry powder, breath-actuated inhaler that provides delivered doses and lung deposition of tiotropium that are, over a wide range, not influenced by the severity of chronic obstructive pulmonary disease (COPD). Tiotropium Respimat® is a propellant-free, multi-dose inhaler that delivers a metered dose of medication as a fine, slow-moving, long-lasting soft mist, independently of patient inspiratory effort. The high fine-particle fraction of droplets produced by the Respimat® inhaler optimizes the efficiency of drug delivery to the lungs.
METHODS
To help inform the choice of tiotropium inhaler for prescribers and patients, this systematic review summarizes the available pharmacokinetic, efficacy and safety data from comparative studies of tiotropium Respimat® and tiotropium HandiHaler® in COPD, focusing on the licensed once-daily doses of 5 and 18 μg, respectively. Data sources reviewed include publications and abstracts identified from database searches.
RESULTS
Published evidence from comparative studies suggests that tiotropium Respimat® 5 μg and tiotropium HandiHaler® 18 μg provide similar clinical outcomes in patients with COPD.
CONCLUSIONS
The findings indicate that physicians can base their decision about an inhaler for tiotropium on factors other than efficacy or safety. These could be patient preference for a particular inhaler, ease of use and the efficiency of drug delivery, with the aim of optimizing adherence and clinical outcomes with long-term tiotropium maintenance therapy.
Topics: Administration, Inhalation; Bronchodilator Agents; Forced Expiratory Volume; Humans; Lung; Metered Dose Inhalers; Patient Preference; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials as Topic; Tiotropium Bromide
PubMed: 27724909
DOI: 10.1186/s12890-016-0291-4 -
The Cochrane Database of Systematic... Aug 2016Bronchodilators are a central component for treating exacerbations of chronic obstructive pulmonary disease (COPD) all over the world. Clinicians often use nebulisers as... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Bronchodilators are a central component for treating exacerbations of chronic obstructive pulmonary disease (COPD) all over the world. Clinicians often use nebulisers as a mode of delivery, especially in the acute setting, and many patients seem to benefit from them. However, evidence supporting this choice from systematic analysis is sparse, and available data are frequently biased by the inclusion of asthma patients. Therefore, there is little or no formal guidance regarding the mode of delivery, which has led to a wide variation in practice between and within countries and even among doctors in the same hospital. We assessed the available randomised controlled trials (RCTs) to help guide practice in a more uniform way.
OBJECTIVES
To compare the effects of nebulisers versus pressurised metered dose inhalers (pMDI) plus spacer or dry powder inhalers (DPI) in bronchodilator therapy for exacerbations of COPD.
SEARCH METHODS
We searched the Cochrane Airways Group Trial Register and reference lists of articles up to 1 July 2016.
SELECTION CRITERIA
RCTs of both parallel and cross-over designs. We included RCTs during COPD exacerbations, whether measured during hospitalisation or in an outpatient setting. We excluded RCTs involving mechanically ventilated patients due to the different condition of both patients and airways in this setting.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion, extracted data and assessed the risk of bias. We report results with 95% confidence intervals (CIs).
MAIN RESULTS
This review includes eight studies with a total of 250 participants comparing nebuliser versus pMDI plus spacer treatment. We identified no studies comparing DPI with nebulisers. We found two studies assessing the primary outcome of 'change in forced expiratory volume in one second (FEV1) one hour after dosing'. We could not pool these studies, but both showed a non-significant difference in favour of the nebuliser group, with similar frequencies of serious adverse events. For the secondary outcome, 'change in FEV1 closest to one hour after dosing': we found a significant difference of 83 ml (95% CI 10 to 156, P = 0.03) in favour of nebuliser treatment. For the secondary outcome of adverse events, we found a non-significant odds ratio of 1.65 (95% CI 0.42 to 6.48) in favour of the pMDI plus spacer group.
AUTHORS' CONCLUSIONS
There is a lack of evidence in favour of one mode of delivery over another for bronchodilators during exacerbations of COPD. We found no difference between nebulisers versus pMDI plus spacer regarding the primary outcomes of FEV1 at one hour and safety. For the secondary outcome 'change in FEV1 closest to one hour after dosing' during an exacerbation of COPD, we found a greater improvement in FEV1 when treating with nebulisers than with pMDI plus spacers.A limited amount of data are available (eight studies involving 250 participants). These studies were difficult to pool, of low quality and did not provide enough evidence to favour one mode of delivery over another. No data of sufficient quality have been published comparing nebulisers versus DPIs in this setting. More studies are required to assess the optimal mode of delivery during exacerbations of COPD.
Topics: Bronchodilator Agents; Disease Progression; Dry Powder Inhalers; Forced Expiratory Volume; Humans; Inhalation Spacers; Metered Dose Inhalers; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials as Topic; Time Factors
PubMed: 27569680
DOI: 10.1002/14651858.CD011826.pub2 -
The Cochrane Database of Systematic... Aug 2016Pulmonary hypertension is a condition of complex aetiology that culminates in right heart failure and early death. Soluble guanylate cyclase (sGC) stimulators are a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pulmonary hypertension is a condition of complex aetiology that culminates in right heart failure and early death. Soluble guanylate cyclase (sGC) stimulators are a promising class of agents that have recently gained approval for use.
OBJECTIVES
To evaluate the efficacy of sGC stimulators in pulmonary hypertension.
SEARCH METHODS
We searched CENTRAL (Cochrane Central Register of Controlled Trials), MEDLINE, EMBASE and the reference lists of articles. Searches are current as of 12 February 2016.
SELECTION CRITERIA
We selected randomised controlled trials (RCTs) involving participants with pulmonary hypertension of all ages, severities and durations of treatment.
DATA COLLECTION AND ANALYSIS
AW, MS and RW independently selected studies, assessed evidence quality and extracted data. This process was overseen by RT and SG. All included studies were sponsored by the drug manufacturer.
MAIN RESULTS
Five trials involving 962 participants are included in this review. All trials were of relatively short duration (< 16 weeks). Due to the heterogenous aetiology of pulmonary hypertension in participants, results are best considered according to each pulmonary hypertension subtype.Pooled analysis shows a mean difference (MD) increase in six-minute walking distance (6MWD) of 30.13 metres (95% CI 5.29 to 54.96; participants = 659; studies = 3). On subgroup analysis, for pulmonary arterial hypertension (PAH) there was no effect noted (6MWD; MD 11.91 metres, 95% CI -44.92 to 68.75; participants = 398; studies = 2), and in chronic thromboembolic pulmonary hypertension (CTEPH) sGC stimulators improved 6MWD by an MD of 45 metres (95% CI 23.87 to 66.13; participants = 261; studies = 1). Data for left heart disease-associated PH was not available for pooling. Importantly, when participants receiving phosphodiesterase inhibitors were excluded, sGC stimulators increased 6MWD by a MD of 36 metres in PAH. The second primary outcome, mortality, showed no change on pooled analysis against placebo (Peto odds ratio (OR) 0.57, 95% CI 0.18 to 1.80).Pooled secondary outcomes include an increase in World Health Organization (WHO) functional class (OR 1.53, 95% CI 0.87 to 2.72; participants = 858; studies = 4), no effect on clinical worsening (OR 0.45, 95% CI 0.17 to 1.14; participants = 842; studies = 3), and a reduction in mean pulmonary artery pressure (MD -2.77 mmHg, 95% CI -4.96 to -0.58; participants = 744; studies = 5). There was no significant difference in serious adverse events on pooled analysis (OR 1.12, 95% CI 0.66 to 1.90; participants = 818; studies = 5) or when analysed at PAH (MD -3.50, 95% CI -5.54 to -1.46; participants = 344; studies = 1), left heart disease associated subgroups (OR 1.56, 95% CI 0.78 to 3.13; participants = 159; studies = 2) or CTEPH subgroups (OR 1.29, 95% CI 0.65 to 2.56; participants = 261; studies = 1).It is important to consider the results for PAH in the context of a person who is not also receiving a phosphodiesterase-V inhibitor, a contra-indication to sGC stimulator use. It should also be noted that CTEPH results are applicable to inoperable or recurrent CTEPH only.Evidence was rated according to the GRADE scoring system. One outcome was considered high quality, two were moderate, and eight were of low or very low quality, meaning that for many of the outcomes the true effect could differ substantially from our estimate. There were only minor concerns regarding the risk of bias in these trials, all being RCTs largely following the original protocol. Most trials employed an intention-to-treat analysis.
AUTHORS' CONCLUSIONS
sGC stimulators improve pulmonary artery pressures in people with PAH (who are treatment naive or receiving a prostanoid or endothelin antagonist) or those with recurrent or inoperable CTEPH. In these settings this can be achieved without notable complication. However, sGC stimulators should not be taken by people also receiving phosphodiestase-V inhibitors or nitrates due to the risks of hypotension, and there is currently no evidence supporting their use in pulmonary hypertension associated with left heart disease. There is no evidence supporting their use in children. These conclusions are based on data with limitations, including unavailable data from two of the trials.
Topics: Adult; Female; Guanylate Cyclase; Humans; Hypertension, Pulmonary; Male; Pyrazoles; Pyrimidines; Randomized Controlled Trials as Topic; Time Factors; Walking
PubMed: 27482837
DOI: 10.1002/14651858.CD011205.pub2 -
The Cochrane Database of Systematic... Jun 2016Tai Chi, a systematic callisthenic exercise first developed in ancient China, involves a series of slow and rhythmic circular motions. It emphasises use of 'mind' or... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Tai Chi, a systematic callisthenic exercise first developed in ancient China, involves a series of slow and rhythmic circular motions. It emphasises use of 'mind' or concentration to control breathing and circular body motions to facilitate flow of internal energy (i.e. 'qi') within the body. Normal flow of 'qi' is believed to be essential to sustain body homeostasis, ultimately leading to longevity. The effect of Tai Chi on balance and muscle strength in the elderly population has been reported; however, the effect of Tai Chi on dyspnoea, exercise capacity, pulmonary function and psychosocial status among people with chronic obstructive pulmonary disease (COPD) remains unclear.
OBJECTIVES
• To explore the effectiveness of Tai Chi in reducing dyspnoea and improving exercise capacity in people with COPD.• To determine the influence of Tai Chi on physiological and psychosocial functions among people with COPD.
SEARCH METHODS
We searched the Cochrane Airways Group Specialised Register of trials (which included the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED) and PsycINFO); handsearched respiratory journals and meeting abstracts; and searched Chinese medical databases including Wanfang Data, Chinese Medical Current Contents (CMCC), Chinese Biomedical Database (CBM), China Journal Net (CJN) and China Medical Academic Conference (CMAC), from inception to September 2015. We checked the reference lists of all primary studies and review articles for relevant additional references.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing Tai Chi (Tai Chi alone or Tai Chi in addition to another intervention) versus control (usual care or another intervention identical to that used in the Tai Chi group) in people with COPD. Two independent review authors screened and selected studies.
DATA COLLECTION AND ANALYSIS
Two independent review authors extracted data from included studies and assessed risk of bias on the basis of suggested criteria listed in the Cochrane Handbook for Systematic Reviews of Interventions. We extracted post-programme data and entered them into RevMan software (version 5.3) for data synthesis and analysis.
MAIN RESULTS
We included a total of 984 participants from 12 studies (23 references) in this analysis. We included only those involved in Tai Chi and the control group (i.e. 811 participants) in the final analysis. Study sample size ranged from 10 to 206, and mean age ranged from 61 to 74 years. Programmes lasted for six weeks to one year. All included studies were RCTs; three studies used allocation concealment, six reported blinded outcome assessors and three studies adopted an intention-to-treat approach to statistical analysis. No adverse events were reported. Quality of evidence of the outcomes ranged from very low to moderate.Analysis was split into three comparisons: (1) Tai Chi versus usual care; (2) Tai Chi and breathing exercise versus breathing exercise alone; and (3) Tai Chi and exercise versus exercise alone.Comparison of Tai Chi versus usual care revealed that Tai Chi demonstrated a longer six-minute walk distance (mean difference (MD) 29.64 metres, 95% confidence interval (CI) 10.52 to 48.77 metres; participants = 318; I(2) = 59%) and better pulmonary function (i.e. forced expiratory volume in one second, MD 0.11 L, 95% CI 0.02 to 0.20 L; participants = 258; I(2) = 0%) in post-programme data. However, the effects of Tai Chi in reducing dyspnoea level and improving quality of life remain inconclusive. Data are currently insufficient for evaluating the impact of Tai Chi on maximal exercise capacity, balance and muscle strength in people with COPD. Comparison of Tai Chi and other interventions (i.e. breathing exercise or exercise) versus other interventions shows no superiority and no additional effects on symptom improvement nor on physical and psychosocial outcomes with Tai Chi.
AUTHORS' CONCLUSIONS
No adverse events were reported, implying that Tai Chi is safe to practise in people with COPD. Evidence of very low to moderate quality suggests better functional capacity and pulmonary function in post-programme data for Tai Chi versus usual care. When Tai Chi in addition to other interventions was compared with other interventions alone, Tai Chi did not show superiority and showed no additional effects on symptoms nor on physical and psychosocial function improvement in people with COPD. With the diverse style and number of forms being adopted in different studies, the most beneficial protocol of Tai Chi style and number of forms could not be commented upon. Hence, future studies are warranted to address these topics.
Topics: Aged; Breathing Exercises; Humans; Middle Aged; Pulmonary Disease, Chronic Obstructive; Quality of Life; Randomized Controlled Trials as Topic; Tai Ji; Walking
PubMed: 27272131
DOI: 10.1002/14651858.CD009953.pub2 -
Medicine May 2016Presently, there is no recommendation on how to assess functional status of chronic obstructive pulmonary disease (COPD) patients. This study aimed to summarize and... (Review)
Review
Presently, there is no recommendation on how to assess functional status of chronic obstructive pulmonary disease (COPD) patients. This study aimed to summarize and systematically evaluate these measures.Studies on measures of COPD patients' functional status published before the end of January 2015 were included using a search filters in PubMed and Web of Science, screening reference lists of all included studies, and cross-checking against some relevant reviews. After title, abstract, and main text screening, the remaining was appraised using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) 4-point checklist. All measures from these studies were rated according to best-evidence synthesis and the best-rated measures were selected.A total of 6447 records were found and 102 studies were reviewed, suggesting 44 performance-based measures and 14 patient-reported measures. The majority of the studies focused on internal consistency, reliability, and hypothesis testing, but only 21% of them employed good or excellent methodology. Their common weaknesses include lack of checks for unidimensionality, inadequate sample sizes, no prior hypotheses, and improper methods. On average, patient-reported measures perform better than performance-based measures. The best-rated patient-reported measures are functional performance inventory (FPI), functional performance inventory short form (FPI-SF), living with COPD questionnaire (LCOPD), COPD activity rating scale (CARS), University of Cincinnati dyspnea questionnaire (UCDQ), shortness of breath with daily activities (SOBDA), and short-form pulmonary functional status scale (PFSS-11), and the best-rated performance-based measures are exercise testing: 6-minute walk test (6MWT), endurance treadmill test, and usual 4-meter gait speed (usual 4MGS).Further research is needed to evaluate the reliability and validity of performance-based measures since present studies failed to provide convincing evidence. FPI, FPI-SF, LCOPD, CARS, UCDQ, SOBDA, PFSS-11, 6MWT, endurance treadmill test, and usual 4MGS performed well and are preferable to assess functional status of COPD patients.
Topics: Activities of Daily Living; Dyspnea; Humans; Psychometrics; Pulmonary Disease, Chronic Obstructive; Reproducibility of Results; Surveys and Questionnaires; Walk Test
PubMed: 27196472
DOI: 10.1097/MD.0000000000003672 -
The Cochrane Database of Systematic... Mar 2016Levels of physical fitness are low after stroke. It is unknown whether improving physical fitness after stroke reduces disability. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Levels of physical fitness are low after stroke. It is unknown whether improving physical fitness after stroke reduces disability.
OBJECTIVES
To determine whether fitness training after stroke reduces death, dependence, and disability and to assess the effects of training with regard to adverse events, risk factors, physical fitness, mobility, physical function, quality of life, mood, and cognitive function. Interventions to improve cognitive function have attracted increased attention after being identified as the highest rated research priority for life after stroke. Therefore we have added this class of outcomes to this updated review.
SEARCH METHODS
We searched the Cochrane Stroke Group Trials Register (last searched February 2015), the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 1: searched February 2015), MEDLINE (1966 to February 2015), EMBASE (1980 to February 2015), CINAHL (1982 to February 2015), SPORTDiscus (1949 to February 2015), and five additional databases (February 2015). We also searched ongoing trials registers, handsearched relevant journals and conference proceedings, screened reference lists, and contacted experts in the field.
SELECTION CRITERIA
Randomised trials comparing either cardiorespiratory training or resistance training, or both (mixed training), with usual care, no intervention, or a non-exercise intervention in stroke survivors.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, assessed quality and risk of bias, and extracted data. We analysed data using random-effects meta-analyses. Diverse outcome measures limited the intended analyses.
MAIN RESULTS
We included 58 trials, involving 2797 participants, which comprised cardiorespiratory interventions (28 trials, 1408 participants), resistance interventions (13 trials, 432 participants), and mixed training interventions (17 trials, 957 participants). Thirteen deaths occurred before the end of the intervention and a further nine before the end of follow-up. No dependence data were reported. Diverse outcome measures restricted pooling of data. Global indices of disability show moderate improvement after cardiorespiratory training (standardised mean difference (SMD) 0.52, 95% confidence interval (CI) 0.19 to 0.84; P value = 0.002) and by a small amount after mixed training (SMD 0.26, 95% CI 0.04 to 0.49; P value = 0.02); benefits at follow-up (i.e. after training had stopped) were unclear. There were too few data to assess the effects of resistance training.Cardiorespiratory training involving walking improved maximum walking speed (mean difference (MD) 6.71 metres per minute, 95% CI 2.73 to 10.69), preferred gait speed (MD 4.28 metres per minute, 95% CI 1.71 to 6.84), and walking capacity (MD 30.29 metres in six minutes, 95% CI 16.19 to 44.39) at the end of the intervention. Mixed training, involving walking, increased preferred walking speed (MD 4.54 metres per minute, 95% CI 0.95 to 8.14), and walking capacity (MD 41.60 metres per six minutes, 95% CI 25.25 to 57.95). Balance scores improved slightly after mixed training (SMD 0.27, 95% CI 0.07 to 0.47). Some mobility benefits also persisted at the end of follow-up. The variability, quality of the included trials, and lack of data prevents conclusions about other outcomes and limits generalisability of the observed results.
AUTHORS' CONCLUSIONS
Cardiorespiratory training and, to a lesser extent, mixed training reduce disability during or after usual stroke care; this could be mediated by improved mobility and balance. There is sufficient evidence to incorporate cardiorespiratory and mixed training, involving walking, within post-stroke rehabilitation programmes to improve the speed and tolerance of walking; some improvement in balance could also occur. There is insufficient evidence to support the use of resistance training. The effects of training on death and dependence after stroke are still unclear but these outcomes are rarely observed in physical fitness training trials. Cognitive function is under-investigated despite being a key outcome of interest for patients. Further well-designed randomised trials are needed to determine the optimal exercise prescription and identify long-term benefits.
Topics: Activities of Daily Living; Exercise Therapy; Humans; Physical Fitness; Randomized Controlled Trials as Topic; Resistance Training; Stroke; Stroke Rehabilitation; Walking
PubMed: 27010219
DOI: 10.1002/14651858.CD003316.pub6 -
Health Technology Assessment... Feb 2016In recent years, meters for continuous monitoring of interstitial fluid glucose have been introduced to help people with type 1 diabetes mellitus (T1DM) to achieve... (Review)
Review
Integrated sensor-augmented pump therapy systems [the MiniMed® Paradigm™ Veo system and the Vibe™ and G4® PLATINUM CGM (continuous glucose monitoring) system] for managing blood glucose levels in type 1 diabetes: a systematic review and economic evaluation.
BACKGROUND
In recent years, meters for continuous monitoring of interstitial fluid glucose have been introduced to help people with type 1 diabetes mellitus (T1DM) to achieve better control of their disease.
OBJECTIVE
The objective of this project was to summarise the evidence on the clinical effectiveness and cost-effectiveness of the MiniMed(®) Paradigm™ Veo system (Medtronic Inc., Northridge, CA, USA) and the Vibe™ (Animas(®) Corporation, West Chester, PA, USA) and G4(®) PLATINUM CGM (continuous glucose monitoring) system (Dexcom Inc., San Diego, CA, USA) in comparison with multiple daily insulin injections (MDIs) or continuous subcutaneous insulin infusion (CSII), both with either self-monitoring of blood glucose (SMBG) or CGM, for the management of T1DM in adults and children.
DATA SOURCES
A systematic review was conducted in accordance with the principles of the Centre for Reviews and Dissemination guidance and the National Institute for Health and Care Excellence Diagnostic Assessment Programme manual. We searched 14 databases, three trial registries and two conference proceedings from study inception up to September 2014. In addition, reference lists of relevant systematic reviews were checked. In the absence of randomised controlled trials directly comparing Veo or an integrated CSII + CGM system, such as Vibe, with comparator interventions, indirect treatment comparisons were performed if possible.
METHODS
A commercially available cost-effectiveness model, the IMS Centre for Outcomes Research and Effectiveness diabetes model version 8.5 (IMS Health, Danbury, CT, USA), was used for this assessment. This model is an internet-based, interactive simulation model that predicts the long-term health outcomes and costs associated with the management of T1DM and type 2 diabetes. The model consists of 15 submodels designed to simulate diabetes-related complications, non-specific mortality and costs over time. As the model simulates individual patients over time, it updates risk factors and complications to account for disease progression.
RESULTS
Fifty-four publications resulting from 19 studies were included in the review. Overall, the evidence suggests that the Veo system reduces hypoglycaemic events more than other treatments, without any differences in other outcomes, including glycated haemoglobin (HbA1c) levels. We also found significant results in favour of the integrated CSII + CGM system over MDIs with SMBG with regard to HbA1c levels and quality of life. However, the evidence base was poor. The quality of the included studies was generally low, often with only one study comparing treatments in a specific population at a specific follow-up time. In particular, there was only one study comparing Veo with an integrated CSII + CGM system and only one study comparing Veo with a CSII + SMBG system in a mixed population. Cost-effectiveness analyses indicated that MDI + SMBG is the option most likely to be cost-effective, given the current threshold of £30,000 per quality-adjusted life-year gained, whereas integrated CSII + CGM systems and Veo are dominated and extendedly dominated, respectively, by stand-alone, non-integrated CSII with CGM. Scenario analyses did not alter these conclusions. No cost-effectiveness modelling was conducted for children or pregnant women.
CONCLUSIONS
The Veo system does appear to be better than the other systems considered at reducing hypoglycaemic events. However, in adults, it is unlikely to be cost-effective. Integrated systems are also generally unlikely to be cost-effective given that stand-alone systems are cheaper and, possibly, no less effective. However, evidence in this regard is generally lacking, in particular for children. Future trials in specific child, adolescent and adult populations should include longer term follow-up and ratings on the European Quality of Life-5 Dimensions scale at various time points with a view to informing improved cost-effectiveness modelling.
STUDY REGISTRATION
PROSPERO Registration Number CRD42014013764.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Blood Glucose; Blood Glucose Self-Monitoring; Cost-Benefit Analysis; Diabetes Complications; Diabetes Mellitus, Type 1; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Insulin; Quality of Life; Technology Assessment, Biomedical
PubMed: 26933827
DOI: 10.3310/hta20170 -
Archives of Physical Medicine and... Apr 2016To systematically review the evidence to determine energy expenditure (EE) in volume of oxygen uptake (V̇O2) (mL/kg/min) and energy cost in oxygen uptake per meter... (Review)
Review
OBJECTIVES
To systematically review the evidence to determine energy expenditure (EE) in volume of oxygen uptake (V̇O2) (mL/kg/min) and energy cost in oxygen uptake per meter walked (V̇O2/walking speed; mL/kg/m) during walking poststroke and how it compares with healthy controls; and to determine how applicable current exercise prescription guidelines are to stroke survivors.
DATA SOURCES
Cochrane Central Register of Controlled Trials, MEDLINE, Embase, and CINAHL were searched on October 9, 2014, using search terms related to stroke and EE. Additionally, we screened reference lists of eligible studies.
STUDY SELECTION
Two independent reviewers screened titles and abstracts of 2115 identified references. After screening the full text of 144 potentially eligible studies, we included 29 studies (stroke survivors: n=501, healthy controls: n=123), including participants with confirmed stroke and a measure of V̇O2 during walking using breath-by-breath analysis. Studies with (9 studies) and without (20 studies) a healthy control group were included.
DATA EXTRACTION
Two reviewers independently extracted data using a standard template, including patient characteristics, outcome data, and study methods.
DATA SYNTHESIS
Mean age of stroke survivors was 57 years (range, 40-67y). Poststroke EE was highly variable across studies and could not be pooled because of high heterogeneity. EE during steady-state overground walking at matched speeds was significantly higher in stroke survivors than healthy controls (mean difference in V̇O2, 4.06 mL/kg/min; 95% confidence interval [CI], 2.21-5.91; 1 study; n=26); there was no significant group difference at self-selected speeds. Energy cost during steady-state overground walking was higher in stroke survivors at both self-selected (mean difference, .47 mL/kg/m; 95% CI, .29-.66; 2 studies; n=38) and matched speeds compared with healthy controls (mean difference, .27 mL/kg/m; 95% CI, .03-.51; 1 study; n=26).
CONCLUSIONS
Stroke survivors expend more energy during walking than healthy controls. Low-intensity exercise as described in guidelines might be at a moderate intensity level for stroke survivors; there is a need for stroke-specific exercise guidelines.
Topics: Adult; Aged; Case-Control Studies; Energy Metabolism; Exercise Therapy; Female; Healthy Volunteers; Humans; Male; Middle Aged; Oxygen Consumption; Stroke; Stroke Rehabilitation; Survivors; Walking
PubMed: 26686877
DOI: 10.1016/j.apmr.2015.11.007