Enfermedad pulmonar crónica, ensayos clínicos

[Inhaled corticosteroids in COPD and the risk of pneumonia]

Pneumologia. 2010 Apr-Jun;59(2):74-6

Authors: Niţu M, Medregoniu D, Olteanu M, Golli A, Olteanu M, Măceşeanu A, Medregoniu R

Concern is continuing about increased risk of pneumonia in patients with chronic obstructive pulmonary disease (COPD) who use inhaled corticosteroids. The aim of this work is to present a few results from the literature about this problem.

PMID: 20695361 [PubMed - indexed for MEDLINE]

Noninvasive positive pressure ventilation as a weaning strategy for intubated adults with respiratory failure.

Cochrane Database Syst Rev. 2010;8:CD004127

Authors: Burns KE, Adhikari NK, Keenan SP, Meade MO

BACKGROUND: Noninvasive positive pressure ventilation (NPPV) provides ventilatory support without the need for an invasive airway approach. Interest has emerged in using NPPV to facilitate earlier removal of an endotracheal tube and decrease complications associated with prolonged intubation. OBJECTIVES: To summarize the evidence comparing NPPV and invasive positive pressure ventilation (IPPV) weaning on clinical outcomes in intubated adults with respiratory failure. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2008), MEDLINE (January 1966 to April 2008), EMBASE (January 1980 to April 2008), proceedings from four conferences, and personal files; and contacted authors to identify randomized controlled trials comparing NPPV and IPPV weaning. SELECTION CRITERIA: Randomized and quasi-randomized studies comparing early extubation with immediate application of NPPV to IPPV weaning in intubated adults with respiratory failure. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and abstracted data according to prespecified criteria. Sensitivity and subgroup analyses were planned to assess the impact of (i) excluding quasi-randomized trials, and (ii) the etiology of respiratory failure on selected outcomes. MAIN RESULTS: We identified 12 trials of moderate to good quality that involved 530 participants with predominantly chronic obstructive pulmonary disease (COPD). Compared to the IPPV strategy, NPPV significantly decreased mortality (relative risk (RR) 0.55, 95% confidence Interval (CI) 0.38 to 0.79), ventilator associated pneumonia (RR 0.29, 95% CI 0.19 to 0.45), length of stay in an intensive care unit (weighted mean difference (WMD) -6.27 days, 95% CI -8.77 to -3.78) and hospital (WMD -7.19 days, 95% CI -10.80 to -3.58), total duration of ventilation (WVD) -5.64 days (95% CI -9.50 to -1.77) and duration of endotracheal mechanical ventilation (WMD - 7.81 days, 95% CI -11.31 to -4.31). Noninvasive weaning had no effect on weaning failures or the duration of ventilation related to weaning. Excluding a single quasi-randomized trial maintained the significant reduction in mortality and ventilator associated pneumonia. Subgroup analyses suggested that the benefits on mortality and weaning failures were nonsignificantly greater in trials enrolling exclusively COPD patients versus mixed populations. AUTHORS' CONCLUSIONS: Summary estimates from 12 small studies of moderate to good quality that included predominantly COPD patients demonstrated a consistent, positive effect on mortality and ventilator associated pneumonia. The net clinical benefits associated with noninvasive weaning remain to be fully elucidated.

PMID: 20687075 [PubMed - indexed for MEDLINE]

Long-term effectiveness and cost-effectiveness of smoking cessation interventions in patients with COPD.

Thorax. 2010 Aug;65(8):711-8

Authors: Hoogendoorn M, Feenstra TL, Hoogenveen RT, Rutten-van Mölken MP

BACKGROUND: The aim of this study was to estimate the long-term (cost-) effectiveness of smoking cessation interventions for patients with chronic obstructive pulmonary disease (COPD). METHODS: A systematic review was performed of randomised controlled trials on smoking cessation interventions in patients with COPD reporting 12-month biochemical validated abstinence rates. The different interventions were grouped into four categories: usual care, minimal counselling, intensive counselling and intensive counselling + pharmacotherapy ('pharmacotherapy'). For each category the average 12-month continuous abstinence rate and intervention costs were estimated. A dynamic population model for COPD was used to project the long-term (cost-) effectiveness (25 years) of 1-year implementation of the interventions for 50% of the patients with COPD who smoked compared with usual care. Uncertainty and one-way sensitivity analyses were performed for variations in the calculation of the abstinence rates, the type of projection, intervention costs and discount rates. RESULTS: Nine studies were selected. The average 12-month continuous abstinence rates were estimated to be 1.4% for usual care, 2.6% for minimal counselling, 6.0% for intensive counselling and 12.3% for pharmacotherapy. Compared with usual care, the costs per quality-adjusted life year (QALY) gained for minimal counselling, intensive counselling and pharmacotherapy were euro 16 900, euro 8200 and euro 2400, respectively. The results were most sensitive to variations in the estimation of the abstinence rates and discount rates. CONCLUSION: Compared with usual care, intensive counselling and pharmacotherapy resulted in low costs per QALY gained with ratios comparable to results for smoking cessation in the general population. Compared with intensive counselling, pharmacotherapy was cost saving and dominated the other interventions.

PMID: 20685746 [PubMed - indexed for MEDLINE]

Impact of consumer health informatics applications.

Evid Rep Technol Assess (Full Rep). 2009 Oct;(188):1-546

Authors: Gibbons MC, Wilson RF, Samal L, Lehman CU, Dickersin K, Lehmann HP, Aboumatar H, Finkelstein J, Shelton E, Sharma R, Bass EB

OBJECTIVE: The objective of the report is to review the evidence on the impact of consumer health informatics (CHI) applications on health outcomes, to identify the knowledge gaps and to make recommendations for future research. DATA SOURCES: We searched MEDLINE, EMBASE, The Cochrane Library, Scopus, and CINAHL databases, references in eligible articles and the table of contents of selected journals; and query of experts. METHODS: Paired reviewers reviewed citations to identify randomized controlled trials (RCTs) of the impact of CHI applications, and all studies that addressed barriers to use of CHI applications. All studies were independently assessed for quality. All data was abstracted, graded, and reviewed by 2 different reviewers. RESULTS: One hundred forty-six eligible articles were identified including 121 RCTs. Studies were very heterogeous and of variable quality. Four of five asthma care studies found significant positive impact of a CHI application on at least one healthcare process measure. In terms of the impact of CHI on intermediate health outcomes, significant positive impact was demonstrated in at least one intermediate health outcome of; all three identified breast cancer studies, 89 percent of 32 diet, exercise, physical activity, not obesity studies, all 7 alcohol abuse studies, 58 percent of 19 smoking cessation studies, 40 percent of 12 obesity studies, all 7 diabetes studies, 88 percent of 8 mental health studies, 25 percent of 4 asthma/COPD studies, and one of two menopause/HRT utilization studies. Thirteen additional single studies were identified and each found evidence of significant impact of a CHI application on one or more intermediate outcomes. Eight studies evaluated the effect of CHI on the doctor patient relationship. Five of these studies demonstrated significant positive impact of CHI on at least one aspect of the doctor patient relationship. In terms of the impact of CHI on clinical outcomes, significant positive impact was demonstrated in at least one clinical outcome of; one of three breast cancer studies, four of five diet, exercise, or physical activity studies, all seven mental health studies, all three identified diabetes studies. No studies included in this review found any evidence of consumer harm attributable to a CHI application. Evidence was insufficient to determine the economic impact of CHI applications. CONCLUSIONS: Despite study heterogeneity, quality variability, and some data paucity, available literature suggests that select CHI applications may effectively engage consumers, enhance traditional clinical interventions, and improve both intermediate and clinical health outcomes.

PMID: 20629477 [PubMed - indexed for MEDLINE]

Intravenous alpha-1 antitrypsin augmentation therapy for treating patients with alpha-1 antitrypsin deficiency and lung disease.

Cochrane Database Syst Rev. 2010;7:CD007851

Authors: Gøtzsche PC, Johansen HK

BACKGROUND: Alpha-1 antitrypsin deficiency is an inherited disorder that can cause lung disease. People who smoke are more seriously affected and have a greater risk of dying from the disease. OBJECTIVES: To review the benefits and harms of augmentation therapy with alpha-1 antitrypsin in patients with alpha-1 antitrypsin deficiency and lung disease. SEARCH STRATEGY: PubMed, the Cochrane Trials Register and ClinicalTrials.gov (7 January 2010), and the Cochrane Cystic Fibrosis & Genetic Disorders Group's Trials Register (13 March 2009). SELECTION CRITERIA: Randomised trials of augmentation therapy with alpha-1 antitrypsin compared with placebo or no treatment. DATA COLLECTION AND ANALYSIS: The two authors independently selected trials, extracted outcome data and assessed the risk of bias. MAIN RESULTS: Two trials were included (total 140 patients) that ran for two to three years. All patients were ex- or never-smokers and had genetic variants that carried a very high risk of developing chronic obstructive pulmonary disease. Mortality data were not reported. There was no information on harms in the first trial; in the second trial, serious adverse events were reported to have occurred in 10 patients in the active group and in 18 patients in the placebo group. Annual number of exacerbations and quality of life were similar in the two groups; none of the trials reported on average number of lung infections or hospital admissions. Forced expiratory volume in one second deteriorated a little more in the active group than in the placebo group (difference was -20 ml per year; 95% confidence interval -41 to 1; p = 0.06). For carbon monoxide diffusion, the difference was -0.06 mmol/min/kPa per year (95% confidence interval -0.17 to 0.05; p = 0.31). Lung density measured by CT scan deteriorated a little less in the active group than in the placebo group (difference 1.14 g/l; 95% confidence interval 0.14 to 2.14; p = 0.03) over the total course of the trials. AUTHORS' CONCLUSIONS: Augmentation therapy with alpha-1 antitrypsin cannot be recommended, in view of the lack of evidence of clinical benefit and the cost of treatment.

PMID: 20614465 [PubMed - indexed for MEDLINE]

Oxygen therapy for patients with COPD: current evidence and the long-term oxygen treatment trial.

Chest. 2010 Jul;138(1):179-87

Authors: Stoller JK, Panos RJ, Krachman S, Doherty DE, Make B,

Long-term use of supplemental oxygen improves survival in patients with COPD and severe resting hypoxemia. However, the role of oxygen in symptomatic patients with COPD and more moderate hypoxemia at rest and desaturation with activity is unclear. The few long-term reports of supplemental oxygen in this group have been of small size and insufficient to demonstrate a survival benefit. Short-term trials have suggested beneficial effects other than survival in patients with COPD and moderate hypoxemia at rest. In addition, supplemental oxygen appeared to improve exercise performance in small short-term investigations of patients with COPD and moderate hypoxemia at rest and desaturation with exercise, but long-term trials evaluating patient-reported outcomes are lacking. This article reviews the evidence for long-term use of supplemental oxygen therapy and provides a rationale for the National Heart, Lung, and Blood Institute Long-term Oxygen Treatment Trial. The trial plans to enroll subjects with COPD with moderate hypoxemia at rest or desaturation with exercise and compare tailored oxygen therapy to no oxygen therapy.

PMID: 20605816 [PubMed - indexed for MEDLINE]

Network meta-analysis on the log-hazard scale, combining count and hazard ratio statistics accounting for multi-arm trials: a tutorial.

BMC Med Res Methodol. 2010;10:54

Authors: Woods BS, Hawkins N, Scott DA

BACKGROUND: Data on survival endpoints are usually summarised using either hazard ratio, cumulative number of events, or median survival statistics. Network meta-analysis, an extension of traditional pairwise meta-analysis, is typically based on a single statistic. In this case, studies which do not report the chosen statistic are excluded from the analysis which may introduce bias. METHODS: In this paper we present a tutorial illustrating how network meta-analyses of survival endpoints can combine count and hazard ratio statistics in a single analysis on the hazard ratio scale. We also describe methods for accounting for the correlations in relative treatment effects (such as hazard ratios) that arise in trials with more than two arms. Combination of count and hazard ratio data in a single analysis is achieved by estimating the cumulative hazard for each trial arm reporting count data. Correlation in relative treatment effects in multi-arm trials is preserved by converting the relative treatment effect estimates (the hazard ratios) to arm-specific outcomes (hazards). RESULTS: A worked example of an analysis of mortality data in chronic obstructive pulmonary disease (COPD) is used to illustrate the methods. The data set and WinBUGS code for fixed and random effects models are provided. CONCLUSIONS: By incorporating all data presentations in a single analysis, we avoid the potential selection bias associated with conducting an analysis for a single statistic and the potential difficulties of interpretation, misleading results and loss of available treatment comparisons associated with conducting separate analyses for different summary statistics.

PMID: 20537177 [PubMed - indexed for MEDLINE]

The analysis of treatment effects for recurring episodic conditions.

Stat Med. 2010 Jun 30;29(14):1539-58

Authors: Pullenayegum EM, Cook RJ

Many chronic disease processes feature acute episodic conditions which warrant therapeutic intervention to alleviate symptoms or reduce the risk of further complications. Examples of such disease processes arise in fields such as neurology, where migraineurs experience recurrent attacks of migraine, and respirology, where patients suffering from asthma, cystic fibrosis, or chronic obstructive pulmonary disease may experience recurrent exacerbations. In randomized clinical trials, patients suffering from diseases of this sort are often randomized to one of several treatments and followed over a fixed period of time, during which any episodes are treated with the assigned treatment. When the outcome of interest is a response to treatment at each episode, the data have a similar structure to longitudinal data from studies with prescheduled follow-up assessments, and it is commonplace for analyses to be based on the corresponding methodology. However, this approach ignores the fact that the timing of episodes, and hence the number observed in any given period, is stochastic. In this tutorial we demonstrate the biases that result from naive analyses, discuss analyses that account for the complete stochastic nature, and use a recent migraine trial for illustration. We conclude with some considerations for the design of randomized trials where the unit of analysis is the episode rather than the patient.

PMID: 20535764 [PubMed - indexed for MEDLINE]

Action plans with limited patient education only for exacerbations of chronic obstructive pulmonary disease.

Cochrane Database Syst Rev. 2010;5:CD005074

Authors: Walters JA, Turnock AC, Walters EH, Wood-Baker R

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a progressive disease characterised by exacerbations, usually infective in origin, which affect symptoms and quality of life. Action plans may help individuals recognise a deterioration in their symptoms and initiate changes to treatment early, thereby reducing the impact of the exacerbation. OBJECTIVES: To assess the efficacy of action plans in the management of COPD. SEARCH STRATEGY: We searched the Cochrane Airways Group Specialised Register (7 July 2009), CENTRAL, MEDLINE , CINAHL and ongoing trials registers (last searched July 2009). SELECTION CRITERIA: Randomised controlled trials of an individual action plan with minimal or no self management education, compared to control in patients with COPD were included. Studies in asthma and in multi-faceted interventions in which an action plan was combined with other elements such as education programme, exercise programme or outreach visits were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. We contacted investigators for additional information when necessary. MAIN RESULTS: Five studies enrolling 574 participants with moderate or severe COPD, with follow-up from six to twelve months, were included. There was no evidence that action plans reduced health care utilisation; assessed by hospital admission (mean difference (MD) 0.23; 95% CI -0.03 to 0.49), emergency department visits (MD 0.37; 95% CI -0.50 to 1.24) or GP visits (MD 0.53; -0.45, 1.50). Use of action plans was associated with increased initiation of treatment for acute exacerbations. Oral corticosteroid use was increased over 12 months (MD 0.74; 95% CI 0.14 to 1.35) with a significant increase in odds of being treated with antibiotics over 12 months (odds ratio 1.65; 95% CI 1.01 to 2.69). Self management knowledge and intention to initiate appropriate actions were improved in one study; recognition of a severe exacerbation (MD 2.50; 95% CI 1.04 to 3.96) and self initiating action in a severe exacerbation (MD 1.50; 95% CI 0.62 to 2.38). Health-related quality of life data were limited. AUTHORS' CONCLUSIONS: There is evidence that action plans with limited COPD education aid recognition of, and response to, an exacerbation with initiation of antibiotics and corticosteroids. Only one study measured patients' self health appropriate behaviour (decision making and taking action). There is no evidence of reduced healthcare resources utilisation or improved health-related quality of life.The practice of giving patients an action plan and limited self-management education for the management of COPD exacerbations, without a multi-faceted self-management program or ongoing case management cannot be recommended as the standard of care in COPD.

PMID: 20464737 [PubMed - indexed for MEDLINE]

Steroids in COPD: still up in the air?

Eur Respir J. 2010 May;35(5):949-51

Authors: Sin DD, Man SF

PMID: 20436169 [PubMed - indexed for MEDLINE]

[Safety of tiotropium therapy in chronic obstructive lung diseases (COPD)]

Orv Hetil. 2010 May 2;151(18):749-50

Authors: Osztovits J, Fehér J

PMID: 20410002 [PubMed - indexed for MEDLINE]

Metered-dose inhaler technique: the effect of two educational interventions delivered in community pharmacy over time.

J Asthma. 2010 Apr;47(3):251-6

Authors: Bosnic-Anticevich SZ, Sinha H, So S, Reddel HK

Instruction is critical in order to ensure correct technique with pressurized metered-dose inhalers (pMDIs) by patients. The aim of this study was to compare the effects over time of two educational interventions delivered in community pharmacy to pMDI users. In this randomized controlled parallel-group study, pMDI technique was assessed before and after written and verbal instruction, alone or with physical demonstration, at baseline and 4, 8, and 16 weeks. The study recruited 52 subjects with asthma or chronic obstructive pulmonary disease (COPD). Initially only 1/52 (6%) subject had correct pMDI technique (= checklist score 8/8), with mean baseline score 5 (SD 1) for both groups. Written and verbal information improved pMDI technique at 16 weeks (7 +/- 1, p < .05). Addition of physical demonstration resulted in significant improvement at weeks 4, 8, and 16 (7 +/- 1, 7 +/- 1, 7 +/- 1 respectively; p < .05 for each). Subjects receiving written and verbal information alone were less likely to return for follow-up than those receiving physical demonstration (8 weeks: 6/25 versus 19/27; p < .001). By the 8-week visit, 80% subjects in the physical demonstration group had correct technique prior to education, compared with 10% of subjects receiving written and verbal information alone (p < .05). There was some decline in inhaler technique by 16 weeks. The results demonstrate that adding a physical demonstration is more effective in improving pMDI technique than written and verbal instructions alone.

PMID: 20394511 [PubMed - indexed for MEDLINE]

[Meta-analysis of efficacy and safety of oral theophylline in chronic obstructive pulmonary disease]

Zhonghua Yi Xue Za Zhi. 2010 Mar 2;90(8):540-6

Authors: Wang CH, Zhang Q, Li M, Fu PF, Yan ZM, Peng AM, Zhang GL

OBJECTIVE: To evaluate the efficacy and safety of oral theophylline versus placebo in patients with stable chronic obstructive pulmonary disease (COPD). METHODS: The databases Medline, Embase, Web of Science, Cochrane Central Register of Controlled Trials and Chinese Biomedical Database were retrieved by using the key words "Uniphyl or Theophylline or Theo-Dur or theo or Theotrim or Elixophyllin or Elixophyllin or Phyllocontin or aminophylline or Methylxanthine or nuelin or doxofylline" and "obstructive or bronchitis or pulmonary emphysema or bronchial hyperreactivity or COPD or COLD or emphysema" so as to search the materials about the randomized controlled clinical trials comparing the effectiveness of stable COPD treated by oral theophylline and placebo. A meta-analysis was conducted. For continuous variables, the results of individual studies were pooled using fixed-effect weighted mean difference (WMD) with a corresponding 95% confidence interval (CI). Where the results were expressed as dichotomous variables, the relative risk (RR) with 95%CI was calculated. RESULTS: Thirty-four documents about randomized controlled clinical trials, including a total of 2087 patients, from the retrieved 2010 documents accorded to the demand of enrollment. The results of meta-analysis showed that theophylline significantly improved the forced expiratory volume in 1 s, forced vital capacity and peak expiratory flow rate (WMD 0.09 L, 95%CI 0.09 - 0.09; WMD 0.14 L, 95%CI 0.13 - 0.14; WMD 17.0 L/min and 95%CI 6.9 - 27.2 respectively). Arterial oxygen tension and arterial carbon dioxide tension at rest both improved with treatment (WMD 2.89 mm Hg, 95%CI 1.11 - 4.66; WMD -2.05 mm Hg and 95%CI -3.59 to -1.42 respectively). Six-minute walk distance significantly improved (WMD 38.89 meters, 95%CI 21.55 - 56.22) in treatment group. The RR of acute exacerbations was smaller between both groups (RR 0.74, 95%CI 0.59 - 0.93). The RR of total adverse events was similar (RR 1.05, 95%CI 0.95 - 1.16) while RR of drug-related adverse events was greater (RR 2.54, 95%CI 1.37 - 4.70). And there was significant statistical difference. CONCLUSION: Compared with the placebo, theophylline can improve lung function, arterial blood gas tensions and walking distance while the incidence of drug-related adverse events is higher.

PMID: 20367966 [PubMed - indexed for MEDLINE]

Lessons from the major studies in COPD: problems and pitfalls in translating research evidence into practice.

Prim Care Respir J. 2010 Jun;19(2):170-9

Authors: Halpin DM

Translating the growing evidence base on COPD management into practice can be challenging and understanding the strengths and weakness of published studies is crucial. Studies should conform to the standards of CONSORT statement; they should be sufficiently powered, participants should be randomised, there should be assignment concealment, and the outcome measures and analyses should be decided in advance. The interpretation of the results may be affected by age and severity inclusion criteria for the study and the exclusion of patients with co-morbid illnesses. Whether previous medication is continued or stopped can affect the interpretation of the results. Secondary analyses in sub-groups should be viewed with caution unless pre-specified and accommodated in the trial design and power calculations. Real world observational studies may be confounded by non-randomisation of participants but can sometimes yield valuable insights. The way in which the results are presented can influence their interpretation and their magnitude with respect to minimal important differences as well as statistical significance is important. Research help formulate management algorithms but often the questions they address are too specific to allow evidence-based sequencing of therapies.

PMID: 20352172 [PubMed - indexed for MEDLINE]

[Long-term trials assessing pharmacological treatments in COPD: lessons and limitations]

Rev Mal Respir. 2010 Feb;27(2):125-40

Authors: Marchand E

INTRODUCTION: Several long-term studies designed to assess pharmacological treatments for Chronic Obstructive Pulmonary Disease (COPD) have been published recently. Only such long-term studies allow an accurate analysis of the effect of treatments on criteria of effectiveness such as survival or decline in pulmonary function. A review of these studies is opportune. BACKGROUND: The high drop out rate, which is not a random event, leads to serious methodological problems that are of importance in the interpretation of these studies. Post hoc analysis of both the TORCH and UPLIFT trials suggest a positive effect of long-acting bronchodilators on survival. Up to now, no treatment has convincingly demonstrated an effect on the rate of decline of FEV(1). The treatments evaluated lead to a decrease in exacerbation rates and an improvement in quality of life although the effects of inhaled corticosteroids are subject to methodological concerns. The treatments are all well tolerated. VIEWPOINT: The design of future studies should avoid the withdrawal of treatments at enrolment into a study in order to limit the number of drop outs. CONCLUSION: Long-term studies have made important progress in the knowledge, not only of the effects of the treatments assessed but also of the methodological issues which need to be addressed.

PMID: 20206061 [PubMed - indexed for MEDLINE]

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