Patient- and proxy-reported outcome measures instruments for the assessment of asthma control among adult and pediatric population: A protocol for systematic review.

BACKGROUND: Asthma is a chronic airways inflammatory disease considered as a serious public health problem. Since asthma is a lifelong condition, the assessment of its control is important to achieve a better self-management. Based on the advances of the assessment tools, many instruments have been developed to assess asthma control. Therefore, this systematic review aims to assess the measurement properties, the methodological quality, and the content of outcome measures of the available patient- and proxy-reported asthma control instruments. METHODS: This is a systematic review protocol of the measurement properties of asthma control patient- and proxy-reported outcome instruments. Database searches will be primarily performed on MEDLINE, EMBASE, Web of Science, ScienceDirect and PsycINFO. A manual search of websites considered databases for questionnaires and reference lists will also be conducted. The methodological quality of the studies and the measurement properties will be critically appraised using the COSMIN risk of bias (RoB) checklist. The content of all measurement instruments will be compared based on the International Classification of Functioning, Disability and Health framework. RESULTS: The findings from this systematic review will be disseminated through publication in a peer-reviewed journal and presented at scientific conferences. CONCLUSION: The proposed systematic review will produce a comprehensive evaluation of the measurement properties of the currently available asthma control instruments for both adult and pediatric populations. We aim to help researchers and practitioners in their choice of an adequate instrument and to highlight the gaps in currently available tools. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number: CRD42019126042.

Physical therapies for postural abnormalities in people with cystic fibrosis.

BACKGROUND: Cystic fibrosis (CF) is the most common life-threatening, inherited disease in white populations which causes several dysfunctions, including postural abnormalities. Physical therapy may help in some consequences of these postural abnormalities, such as pain, trunk deformity and quality of life. OBJECTIVES: To determine the effects of a range of physical therapies for managing postural abnormalities in people with cystic fibrosis, specifically on quality of life, pain and trunk deformity. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches, hand-searched journals and conference abstract books. We also searched the reference lists of relevant articles and reviews. Additional searches were conducted on ClinicalTrials.gov and on the WHO International Clinical Trials Registry Platform for any planned, ongoing and unpublished studies. Date of the last search: 19 March 2020. SELECTION CRITERIA: Randomised controlled trials examining any modality of physical therapy considered relevant for treating postural disorders compared with each other, no physical therapy, sham treatment or usual care in people with CF (of any age or disease severity). DATA COLLECTION AND ANALYSIS: Two review authors independently selected eligible trials, assessed the risk of bias in each trial and extracted the data. We contacted trial authors to obtain missing or additional information. We assessed the quality of the evidence using the GRADE criteria. MAIN RESULTS: Two trials, involving a total of 50 participants with CF and postural abnormalities, were included in this review. One was in people with stable disease (lasting three months) and one in hospital inpatients experiencing an exacerbation (20 days). Both trials compared manual therapy comprising mobilizations to the rib cage and thoracic spine, treatment of specific muscle dysfunction or tight muscle groups; and postural awareness and education versus medical usual care. The age of participants ranged from 17 years to 58 years. Both trials were conducted in the UK. The following outcomes were measured: change in quality of life, change in pain, change in trunk deformity and change in pulmonary function. Manual therapy may make little or no difference to the change in trunk deformity compared to usual care (low-quality evidence). No results could be analysed for quality of life (very low-quality evidence) and pain outcomes (very low-quality evidence) because of the high heterogeneity between trials. It is uncertain whether the intervention improves lung function: forced vital capacity (very low-quality evidence); forced expiratory volume in one second (very low-quality evidence); or Tiffeneau's index (ratio of forced expiratory volume at one second (FEV1) and forced vital capacity (FVC)). Only one trial (15 participants) measured functional capacity, and the change in walked distance seemed to favour intervention over usual care, but with the possibility of no effect due to wide confidence intervals. The same trial also reported that six participants in the intervention group had positive comments about the intervention and no adverse events were mentioned. AUTHORS' CONCLUSIONS: Due to methodological limitations in the included trials, and in addition to the very low to low quality of the current evidence, there is limited evidence about the benefits of physical therapies on postural abnormalities in people with CF. Therefore, further well-conducted trials with robust methodologies are required considering a prior inclusion criterion to identify the participants who have postural abnormalities.

Breathing exercises for adults with asthma.

BACKGROUND: Breathing exercises have been widely used worldwide as a non-pharmacological therapy to treat people with asthma. Breathing exercises aim to control the symptoms of asthma and can be performed as the Papworth Method, the Buteyko breathing technique, yogic breathing, deep diaphragmatic breathing or any other similar intervention that manipulates the breathing pattern. The training of breathing usually focuses on tidal and minute volume and encourages relaxation, exercise at home, the modification of breathing pattern, nasal breathing, holding of breath, lower rib cage and abdominal breathing. OBJECTIVES: To evaluate the evidence for the efficacy of breathing exercises in the management of people with asthma. SEARCH METHODS: To identify relevant studies we searched The Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL and AMED and performed handsearching of respiratory journals and meeting abstracts. We also consulted trials registers and reference lists of included articles. The most recent literature search was on 4 April 2019. SELECTION CRITERIA: We included randomised controlled trials of breathing exercises in adults with asthma compared with a control group receiving asthma education or, alternatively, with no active control group. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study quality and extracted data. We used Review Manager 5 software for data analysis based on the random-effects model. We expressed continuous outcomes as mean differences (MDs) with confidence intervals (CIs) of 95%. We assessed heterogeneity by inspecting the forest plots. We applied the Chi2 test, with a P value of 0.10 indicating statistical significance, and the I2 statistic, with a value greater than 50% representing a substantial level of heterogeneity. The primary outcome was quality of life. MAIN RESULTS: We included nine new studies (1910 participants) in this update, resulting in a total of 22 studies involving 2880 participants in the review. Fourteen studies used Yoga as the intervention, four studies involved breathing retraining, one the Buteyko method, one the Buteyko method and pranayama, one the Papworth method and one deep diaphragmatic breathing. The studies were different from one another in terms of type of breathing exercise performed, number of participants enrolled, number of sessions completed, period of follow-up, outcomes reported and statistical presentation of data. Asthma severity in participants from the included studies ranged from mild to moderate, and the samples consisted solely of outpatients. Twenty studies compared breathing exercise with inactive control, and two with asthma education control groups. Meta-analysis was possible for the primary outcome quality of life and the secondary outcomes asthma symptoms, hyperventilation symptoms, and some lung function variables. Assessment of risk of bias was impaired by incomplete reporting of methodological aspects of most of the included studies. We did not include adverse effects as an outcome in the review. Breathing exercises versus inactive control For quality of life, measured by the Asthma Quality of Life Questionnaire (AQLQ), meta-analysis showed improvement favouring the breathing exercises group at three months (MD 0.42, 95% CI 0.17 to 0.68; 4 studies, 974 participants; moderate-certainty evidence), and at six months the OR was 1.34 for the proportion of people with at least 0.5 unit improvement in AQLQ, (95% CI 0.97 to 1.86; 1 study, 655 participants). For asthma symptoms, measured by the Asthma Control Questionnaire (ACQ), meta-analysis at up to three months was inconclusive, MD of -0.15 units (95% CI -2.32 to 2.02; 1 study, 115 participants; low-certainty evidence), and was similar over six months (MD -0.08 units, 95% CI -0.22 to 0.07; 1 study, 449 participants). For hyperventilation symptoms, measured by the Nijmegen Questionnaire (from four to six months), meta-analysis showed less symptoms with breathing exercises (MD -3.22, 95% CI -6.31 to -0.13; 2 studies, 118 participants; moderate-certainty evidence), but this was not shown at six months (MD 0.63, 95% CI -0.90 to 2.17; 2 studies, 521 participants). Meta-analyses for forced expiratory volume in 1 second (FEV1) measured at up to three months was inconclusive, MD -0.10 L, (95% CI -0.32 to 0.12; 4 studies, 252 participants; very low-certainty evidence). However, for FEV1 % of predicted, an improvement was observed in favour of the breathing exercise group (MD 6.88%, 95% CI 5.03 to 8.73; five studies, 618 participants). Breathing exercises versus asthma education For quality of life, one study measuring AQLQ was inconclusive up to three months (MD 0.04, 95% CI -0.26 to 0.34; 1 study, 183 participants). When assessed from four to six months, the results favoured breathing exercises (MD 0.38, 95% CI 0.08 to 0.68; 1 study, 183 participants). Hyperventilation symptoms measured by the Nijmegen Questionnaire were inconclusive up to three months (MD -1.24, 95% CI -3.23 to 0.75; 1 study, 183 participants), but favoured breathing exercises from four to six months (MD -3.16, 95% CI -5.35 to -0.97; 1 study, 183 participants). AUTHORS' CONCLUSIONS: Breathing exercises may have some positive effects on quality of life, hyperventilation symptoms, and lung function. Due to some methodological differences among included studies and studies with poor methodology, the quality of evidence for the measured outcomes ranged from moderate to very low certainty according to GRADE criteria. In addition, further studies including full descriptions of treatment methods and outcome measurements are required.

Chest physiotherapy for pneumonia in children.

BACKGROUND: Pneumonia is a lung infection that causes more deaths in children aged under five years than any other single cause. Chest physiotherapy is widely used as adjuvant treatment for pneumonia. Physiotherapy is thought to help remove inflammatory exudates, tracheobronchial secretions, and airway obstructions, and reduce airway resistance to improve breathing and enhance gas exchange. This is an update of a review published in 2013. OBJECTIVES: To assess the effectiveness of chest physiotherapy with regard to time until clinical resolution in children (from birth to 18 years) of either gender with any type of pneumonia. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1), which includes the Cochrane Acute Respiratory Infections Group Specialised Register, MEDLINE (22 February 2018), Embase (22 February 2018), CINAHL (22 February 2018), LILACS (22 February 2018), Web of Science (22 February 2018), and PEDro (22 February 2018). We also searched clinical trials registers (ClinicalTrials.gov and WHO ICTRP) to identify planned, ongoing, and unpublished trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared any type of chest physiotherapy with no chest physiotherapy for children with pneumonia. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. The primary outcomes of interest were mortality, duration of hospital stay, and time to clinical resolution. We used Review Manager 5 software to analyse data and GRADE to assess the quality of the evidence for each outcome. MAIN RESULTS: We included three new RCTs for this update, for a total of six included RCTs involving 559 children aged from 29 days to 12 years with pneumonia who were treated as inpatients. Pneumonia severity was described as moderate in one trial, severe in two trials, and was not stated in three trials. The studies assessed five different interventions: effects of conventional chest physiotherapy (3 studies, 211 children), positive expiratory pressure (1 study, 72 children), continuous positive airway pressure (CPAP) (1 study, 94 children), bubble CPAP (bCPAP) (1 study, 225 children), and assisted autogenic drainage (1 studies, 29 children). The included studies were conducted in Bangladesh, Brazil, China, Egypt, and South Africa. The studies were overall at low risk of bias. Blinding of participants was not possible in most studies, but we considered that the outcomes were unlikely to be influenced by the lack of blinding.All included studies evaluated mortality. However, three studies assessed mortality as an outcome, and only one study of bCPAP reported that deaths occurred. Three deaths occurred in children in the physiotherapy group (N = 79) and 20 deaths in children in the control group (N = 146) (risk ratio (RR) 0.28, 95% confidence interval (CI) 0.08 to 0.90; 559 children; low-quality evidence). It is uncertain whether chest physiotherapy techniques (bCPAP, assisted autogenic drainage, and conventional chest physiotherapy) reduced hospital stay duration (days) (mean difference (MD) 0.10, 95% CI -0.56 to 0.76; 4 studies; low-quality evidence).There was variation among clinical parameters used to define clinical resolution. Two small studies found no difference in resolution of fever between children in the physiotherapy (conventional chest physiotherapy and assisted autogenic drainage) and control groups. Of five studies that considered peripheral oxygen saturation levels, only two reported that use of chest physiotherapy (CPAP and conventional chest physiotherapy) showed a greater improvement in peripheral oxygen saturation levels. However, it was unclear whether respiratory rate (breaths/min) improved after conventional chest physiotherapy (MD -2.25, 95% CI -5.17 to 0.68; 2 studies, 122 children; low-quality evidence). Two studies assessed adverse events (number of events), but only one study reported any events (RR 1.28, 95% CI 0.98 to 1.67; 2 studies, 254 children; low-quality evidence). AUTHORS' CONCLUSIONS: We could draw no reliable conclusions concerning the use of chest physiotherapy for children with pneumonia due to the small number of included trials with differing study characteristics and statistical presentation of data. Future studies should consider the following key points: appropriate sample size with adequate power to detect expected differences, standardisation of chest physiotherapy techniques, appropriate outcomes (such as duration of leukocytosis, and airway clearance), and adverse effects.

Standard (head-down tilt) versus modified (without head-down tilt) postural drainage in infants and young children with cystic fibrosis.

BACKGROUND: Postural drainage is used primarily in infants with cystic fibrosis from diagnosis up to the moment when they are mature enough to actively participate in self-administered treatments. However, there is a risk of gastroesophageal reflux associated with this technique.This is an update of a review published in 2015. OBJECTIVES: To compare the effects of standard postural drainage (15º to 45º head-down tilt) with modified postural drainage (15º to 30º head-up tilt) with regard to gastroesophageal reflux in infants and young children up to six years old with cystic fibrosis in terms of safety and efficacy. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register. We also searched the reference lists of relevant articles and reviews. Additional searches were conducted on ClinicalTrials.gov and on the WHO International Clinical Trials Registry Platform for any planned, ongoing and unpublished studies.The date of the most recent literature searches: 19 June 2017. SELECTION CRITERIA: We included randomised controlled studies that compared two postural drainage regimens (standard and modified postural drainage) with regard to gastroesophageal reflux in infants and young children (up to and including six years old) with cystic fibrosis. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Two review authors independently identified studies for inclusion, extracted outcome data and assessed risk of bias. We resolved disagreements by consensus or by involving a third review author. We contacted study authors to obtain missing or additional information. The quality of the evidence was assessed using GRADE. MAIN RESULTS: Two studies, involving a total of 40 participants, were eligible for inclusion in the review. We included no new studies in the 2018 update. The included studies were different in terms of the age of participants, the angle of tilt, the reported outcomes, the number of sessions and the study duration. The following outcomes were measured: appearance or exacerbation of gastroesophageal reflux episodes; percentage of peripheral oxygen saturation; number of exacerbations of upper respiratory tract symptoms; number of days on antibiotics for acute exacerbations; chest X-ray scores; and pulmonary function tests. One study reported that postural drainage with a 20° head-down position did not appear to exacerbate gastroesophageal reflux. However, the majority of the reflux episodes in this study reached the upper oesophagus (moderate-quality evidence). The second included study reported that modified postural drainage (30° head-up tilt) was associated with fewer number of gastroesophageal reflux episodes and fewer respiratory complications than standard postural drainage (30° head-down tilt) (moderate-quality evidence). The included studies had an overall low risk of bias. One included study was funded by the Sydney Children's Hospital Foundation and the other by the Royal Children's Hospital Research Foundation and Physiotherapy Research Foundation of Australia. Data were not able to be pooled by meta-analysis due to differences in the statistical presentation of the data. AUTHORS' CONCLUSIONS: The limited evidence regarding the comparison between the two regimens of postural drainage is still weak due to the small number of included studies, the small number of participants assessed, the inability to perform any meta-analyses and some methodological issues with the studies. However, it may be inferred that the use of a postural regimen with a 30° head-up tilt is associated with a lower number of gastroesophageal reflux episodes and fewer respiratory complications in the long term. The 20° head-down postural drainage position was not found to be significantly different from the 20° head-up tilt modified position. Nevertheless, the fact that the majority of reflux episodes reached the upper oesophagus should make physiotherapists carefully consider their treatment strategy. We do not envisage that there will be any new trials undertaken that will affect the conclusions of this review; therefore, we do not plan to update this review.