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JAMA Oct 2023The effect of continuous positive airway pressure (CPAP) on secondary cardiovascular disease prevention is highly debated. (Meta-Analysis)
Meta-Analysis
IMPORTANCE
The effect of continuous positive airway pressure (CPAP) on secondary cardiovascular disease prevention is highly debated.
OBJECTIVE
To assess the effect of CPAP treatment for obstructive sleep apnea (OSA) on the risk of adverse cardiovascular events in randomized clinical trials.
DATA SOURCES
PubMed (MEDLINE), EMBASE, Current Controlled Trials: metaRegister of Controlled Trials, ISRCTN Registry, European Union clinical trials database, CENTRAL (Cochrane Central Register of Controlled Trials), and ClinicalTrials.gov databases were systematically searched through June 22, 2023.
STUDY SELECTION
For qualitative and individual participant data (IPD) meta-analysis, randomized clinical trials addressing the therapeutic effect of CPAP on cardiovascular outcomes and mortality in adults with cardiovascular disease and OSA were included.
DATA EXTRACTION AND SYNTHESIS
Two reviewers independently screened records, evaluated potentially eligible primary studies in full text, extracted data, and cross-checked errors. IPD were requested from authors of the selected studies (SAVE [NCT00738179], ISAACC [NCT01335087], and RICCADSA [NCT00519597]).
MAIN OUTCOMES AND MEASURES
One-stage and 2-stage IPD meta-analyses were completed to estimate the effect of CPAP treatment on risk of recurrent major adverse cardiac and cerebrovascular events (MACCEs) using mixed-effect Cox regression models. Additionally, an on-treatment analysis with marginal structural Cox models using inverse probability of treatment weighting was fitted to assess the effect of good adherence to CPAP (≥4 hours per day).
RESULTS
A total of 4186 individual participants were evaluated (82.1% men; mean [SD] body mass index, 28.9 [4.5]; mean [SD] age, 61.2 [8.7] years; mean [SD] apnea-hypopnea index, 31.2 [17] events per hour; 71% with hypertension; 50.1% receiving CPAP [mean {SD} adherence, 3.1 {2.4} hours per day]; 49.9% not receiving CPAP [usual care], mean [SD] follow-up, 3.25 [1.8] years). The main outcome was defined as the first MACCE, which was similar for the CPAP and no CPAP groups (hazard ratio, 1.01 [95% CI, 0.87-1.17]). However, an on-treatment analysis by marginal structural model revealed a reduced risk of MACCEs associated with good adherence to CPAP (hazard ratio, 0.69 [95% CI, 0.52-0.92]).
CONCLUSIONS AND RELEVANCE
Adherence to CPAP was associated with a reduced MACCE recurrence risk, suggesting that treatment adherence is a key factor in secondary cardiovascular prevention in patients with OSA.
Topics: Female; Humans; Male; Middle Aged; Cardiovascular Diseases; Continuous Positive Airway Pressure; Hypertension; Proportional Hazards Models; Sleep Apnea, Obstructive; Risk; Aged; Secondary Prevention; Patient Compliance
PubMed: 37787793
DOI: 10.1001/jama.2023.17465 -
JAMA Cardiology Oct 2023The association between changes in atherosclerotic plaque induced by lipid-lowering therapies (LLTs) and reduction in major adverse cardiovascular events (MACEs) remains... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
The association between changes in atherosclerotic plaque induced by lipid-lowering therapies (LLTs) and reduction in major adverse cardiovascular events (MACEs) remains controversial.
OBJECTIVE
To evaluate the association between coronary plaque regression assessed by intravascular ultrasound (IVUS) and MACEs.
DATA SOURCES
A comprehensive, systematic search of publications in PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science was performed.
STUDY SELECTION
Clinical prospective studies of LLTs reporting change in percent atheroma volume (PAV) assessed by IVUS and describing MACE components were selected.
DATA EXTRACTION AND SYNTHESIS
Reporting was performed in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The association between mean change in PAV and MACEs was analyzed by meta-regression using mixed-effects, 2-level binomial logistic regression models, unadjusted and adjusted for clinical covariates, including mean age, baseline PAV, baseline low-density lipoprotein cholesterol level, and study duration.
MAIN OUTCOME AND MEASURES
Mean PAV change and MACE in intervention and comparator arms were assessed in an updated systematic review and meta-regression analysis of IVUS trials of LLTs that also reported MACEs.
RESULTS
This meta-analysis included 23 studies published between July 2001 and July 2022, including 7407 patients and trial durations ranging from 11 to 104 weeks. Mean (SD) patient age ranged from 55.8 (9.8) to 70.2 (7.6) years, and the number of male patients from 245 of 507 (48.3%) to 24 of 26 (92.3%). Change in PAV across 46 study arms ranged from -5.6% to 3.1%. The number of MACEs ranged from 0 to 72 per study arm (17 groups [37%] reported no events, 9 [20%] reported 1-2 events, and 20 [43%] reported ≥3 events). In unadjusted analysis, a 1% decrease in mean PAV was associated with 17% reduced odds of MACEs (unadjusted OR, 0.83; 95% CI, 0.71-0.98; P = .03), and with a 14% reduction in MACEs in adjusted analysis (adjusted OR, 0.86; 95% CI, 0.75-1.00; P = .050). Further adjustment for cardiovascular risk factors showed a 19% reduced risk (adjusted OR, 0.81; 95% CI, 0.68-0.96; P = .01) per 1% decrease in PAV. A 1% reduction of PAV change between intervention and comparator arms within studies was also associated with a significant 25% reduction in MACEs (OR, 0.75; 95% CI, 0.56-1.00; P = .046).
CONCLUSIONS AND RELEVANCE
In this meta-analysis, regression of atherosclerotic plaque by 1% was associated with a 25% reduction in the odds of MACEs. These findings suggest that change in PAV could be a surrogate marker for MACEs, but given the heterogeneity in the outcomes, additional data are needed.
Topics: Humans; Male; Middle Aged; Plaque, Atherosclerotic; Coronary Artery Disease; Prospective Studies; Regression Analysis
PubMed: 37647074
DOI: 10.1001/jamacardio.2023.2731 -
Journal of Medical Internet Research Nov 2019Wearable sleep monitors are of high interest to consumers and researchers because of their ability to provide estimation of sleep patterns in free-living conditions in a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Wearable sleep monitors are of high interest to consumers and researchers because of their ability to provide estimation of sleep patterns in free-living conditions in a cost-efficient way.
OBJECTIVE
We conducted a systematic review of publications reporting on the performance of wristband Fitbit models in assessing sleep parameters and stages.
METHODS
In adherence with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, we comprehensively searched the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane, Embase, MEDLINE, PubMed, PsycINFO, and Web of Science databases using the keyword Fitbit to identify relevant publications meeting predefined inclusion and exclusion criteria.
RESULTS
The search yielded 3085 candidate articles. After eliminating duplicates and in compliance with inclusion and exclusion criteria, 22 articles qualified for systematic review, with 8 providing quantitative data for meta-analysis. In reference to polysomnography (PSG), nonsleep-staging Fitbit models tended to overestimate total sleep time (TST; range from approximately 7 to 67 mins; effect size=-0.51, P<.001; heterogenicity: I=8.8%, P=.36) and sleep efficiency (SE; range from approximately 2% to 15%; effect size=-0.74, P<.001; heterogenicity: I=24.0%, P=.25), and underestimate wake after sleep onset (WASO; range from approximately 6 to 44 mins; effect size=0.60, P<.001; heterogenicity: I=0%, P=.92) and there was no significant difference in sleep onset latency (SOL; P=.37; heterogenicity: I=0%, P=.92). In reference to PSG, nonsleep-staging Fitbit models correctly identified sleep epochs with accuracy values between 0.81 and 0.91, sensitivity values between 0.87 and 0.99, and specificity values between 0.10 and 0.52. Recent-generation Fitbit models that collectively utilize heart rate variability and body movement to assess sleep stages performed better than early-generation nonsleep-staging ones that utilize only body movement. Sleep-staging Fitbit models, in comparison to PSG, showed no significant difference in measured values of WASO (P=.25; heterogenicity: I=0%, P=.92), TST (P=.29; heterogenicity: I=0%, P=.98), and SE (P=.19) but they underestimated SOL (P=.03; heterogenicity: I=0%, P=.66). Sleep-staging Fitbit models showed higher sensitivity (0.95-0.96) and specificity (0.58-0.69) values in detecting sleep epochs than nonsleep-staging models and those reported in the literature for regular wrist actigraphy.
CONCLUSIONS
Sleep-staging Fitbit models showed promising performance, especially in differentiating wake from sleep. However, although these models are a convenient and economical means for consumers to obtain gross estimates of sleep parameters and time spent in sleep stages, they are of limited specificity and are not a substitute for PSG.
Topics: Actigraphy; Female; Humans; Male; Sleep; Wrist
PubMed: 31778122
DOI: 10.2196/16273 -
Journal of Medical Internet Research Feb 2015Adherence to chronic disease management is critical to achieving improved health outcomes, quality of life, and cost-effective health care. As the burden of chronic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Adherence to chronic disease management is critical to achieving improved health outcomes, quality of life, and cost-effective health care. As the burden of chronic diseases continues to grow globally, so does the impact of non-adherence. Mobile technologies are increasingly being used in health care and public health practice (mHealth) for patient communication, monitoring, and education, and to facilitate adherence to chronic diseases management.
OBJECTIVE
We conducted a systematic review of the literature to evaluate the effectiveness of mHealth in supporting the adherence of patients to chronic diseases management ("mAdherence"), and the usability, feasibility, and acceptability of mAdherence tools and platforms in chronic disease management among patients and health care providers.
METHODS
We searched PubMed, Embase, and EBSCO databases for studies that assessed the role of mAdherence in chronic disease management of diabetes mellitus, cardiovascular disease, and chronic lung diseases from 1980 through May 2014. Outcomes of interest included effect of mHealth on patient adherence to chronic diseases management, disease-specific clinical outcomes after intervention, and the usability, feasibility, and acceptability of mAdherence tools and platforms in chronic disease management among target end-users.
RESULTS
In all, 107 articles met all inclusion criteria. Short message service was the most commonly used mAdherence tool in 40.2% (43/107) of studies. Usability, feasibility, and acceptability or patient preferences for mAdherence interventions were assessed in 57.9% (62/107) of studies and found to be generally high. A total of 27 studies employed randomized controlled trial (RCT) methods to assess impact on adherence behaviors, and significant improvements were observed in 15 of those studies (56%). Of the 41 RCTs that measured effects on disease-specific clinical outcomes, significant improvements between groups were reported in 16 studies (39%).
CONCLUSIONS
There is potential for mHealth tools to better facilitate adherence to chronic disease management, but the evidence supporting its current effectiveness is mixed. Further research should focus on understanding and improving how mHealth tools can overcome specific barriers to adherence.
Topics: Cardiovascular Diseases; Chronic Disease; Diabetes Mellitus; Disease Management; Humans; Lung Diseases; Patient Compliance; Randomized Controlled Trials as Topic; Telemedicine; Text Messaging; Treatment Outcome
PubMed: 25803266
DOI: 10.2196/jmir.3951 -
The Cochrane Database of Systematic... Jun 2022Asthma is the most common chronic lung condition worldwide, affecting 334 million adults and children globally. Despite the availability of effective treatment, such as... (Review)
Review
BACKGROUND
Asthma is the most common chronic lung condition worldwide, affecting 334 million adults and children globally. Despite the availability of effective treatment, such as inhaled corticosteroids (ICS), adherence to maintenance medication remains suboptimal. Poor ICS adherence leads to increased asthma symptoms, exacerbations, hospitalisations, and healthcare utilisation. Importantly, suboptimal use of asthma medication is a key contributor to asthma deaths. The impact of digital interventions on adherence and asthma outcomes is unknown.
OBJECTIVES
To determine the effectiveness of digital interventions for improving adherence to maintenance treatments in asthma.
SEARCH METHODS
We identified trials from the Cochrane Airways Trials Register, which contains studies identified through multiple electronic searches and handsearches of other sources. We also searched trial registries and reference lists of primary studies. We conducted the most recent searches on 1 June 2020, with no restrictions on language of publication. A further search was run in October 2021, but studies were not fully incorporated.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) including cluster- and quasi-randomised trials of any duration in any setting, comparing a digital adherence intervention with a non-digital adherence intervention or usual care. We included adults and children with a clinical diagnosis of asthma, receiving maintenance treatment.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures for data collection. We used GRADE to assess quantitative outcomes where data were available.
MAIN RESULTS
We included 40 parallel randomised controlled trials (RCTs) involving adults and children with asthma (n = 15,207), of which eight are ongoing studies. Of the included studies, 30 contributed data to at least one meta-analysis. The total number of participants ranged from 18 to 8517 (median 339). Intervention length ranged from two to 104 weeks. Most studies (n = 29) reported adherence to maintenance medication as their primary outcome; other outcomes such as asthma control and quality of life were also commonly reported. Studies had low or unclear risk of selection bias but high risk of performance and detection biases due to inability to blind the participants, personnel, or outcome assessors. A quarter of the studies had high risk of attrition bias and selective outcome reporting. We examined the effect of digital interventions using meta-analysis for the following outcomes: adherence (16 studies); asthma control (16 studies); asthma exacerbations (six studies); unscheduled healthcare utilisation (four studies); lung function (seven studies); and quality of life (10 studies). Pooled results showed that patients receiving digital interventions may have increased adherence (mean difference of 14.66 percentage points, 95% confidence interval (CI) 7.74 to 21.57; low-certainty evidence); this is likely to be clinically significant in those with poor baseline medication adherence. Subgroup analysis by type of intervention was significant (P = 0.001), with better adherence shown with electronic monitoring devices (EMDs) (23 percentage points over control, 95% CI 10.84 to 34.16; seven studies), and with short message services (SMS) (12 percentage points over control, 95% CI 6.22 to 18.03; four studies). No significant subgroup differences were seen for interventions having an in-person component versus fully digital interventions, adherence feedback, one or multiple digital components to the intervention, or participant age. Digital interventions were likely to improve asthma control (standardised mean difference (SMD) 0.31 higher, 95% CI 0.17 to 0.44; moderate-certainty evidence) - a small but likely clinically significant effect. They may reduce asthma exacerbations (risk ratio 0.53, 95% CI 0.32 to 0.91; low-certainty evidence). Digital interventions may result in a slight change in unscheduled healthcare utilisation, although some studies reported no or a worsened effect. School or work absence data could not be included for meta-analysis due to the heterogeneity in reporting and the low number of studies. They may result in little or no difference in lung function (forced expiratory volume in one second (FEV)): there was an improvement of 3.58% predicted FEV, 95% CI 1.00% to 6.17%; moderate-certainty evidence); however, this is unlikely to be clinically significant as the FEV change is below 12%. Digital interventions likely increase quality of life (SMD 0.26 higher, 95% CI 0.07 to 0.45; moderate-certainty evidence); however, this is a small effect that may not be clinically significant. Acceptability data showed positive attitudes towards digital interventions. There were no data on cost-effectiveness or adverse events. Our confidence in the evidence was reduced by risk of bias and inconsistency.
AUTHORS' CONCLUSIONS
Overall, digital interventions may result in a large increase in adherence (low-certainty evidence). There is moderate-certainty evidence that digital adherence interventions likely improve asthma control to a degree that is clinically significant, and likely increase quality of life, but there is little or no improvement in lung function. The review found low-certainty evidence that digital interventions may reduce asthma exacerbations. Subgroup analyses show that EMDs may improve adherence by 23% and SMS interventions by 12%, and interventions with an in-person element and adherence feedback may have greater benefits for asthma control and adherence, respectively. Future studies should include percentage adherence as a routine outcome measure to enable comparison between studies and meta-analysis, and use validated questionnaires to assess adherence and outcomes.
Topics: Adrenal Cortex Hormones; Adult; Asthma; Child; Forced Expiratory Volume; Humans; Medication Adherence; Quality of Life
PubMed: 35691614
DOI: 10.1002/14651858.CD013030.pub2 -
The Cochrane Database of Systematic... Mar 2021Cancer cachexia is a multifactorial syndrome characterised by an ongoing loss of skeletal muscle mass, with or without a loss of fat mass, leading to progressive... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cancer cachexia is a multifactorial syndrome characterised by an ongoing loss of skeletal muscle mass, with or without a loss of fat mass, leading to progressive functional impairment. Physical exercise may attenuate cancer cachexia and its impact on patient function. This is the first update of an original Cochrane Review published in Issue 11, 2014, which found no studies to include.
OBJECTIVES
To determine the effectiveness, acceptability and safety of exercise, compared with usual care, no treatment or active control, for cancer cachexia in adults.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, and eight other databases to March 2020. We searched for ongoing studies in trial registries, checked reference lists and contacted experts to seek relevant studies.
SELECTION CRITERIA
We sought randomised controlled trials in adults with cancer cachexia, that compared a programme of exercise alone or in combination with another intervention, with usual care, no treatment or an active control group.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed titles and abstracts for relevance and extracted data on study design, participants, interventions and outcomes from potentially relevant articles. We used standard methodological procedures expected by Cochrane. Our primary outcome was lean body mass and secondary outcomes were adherence to exercise programme, adverse events, muscle strength and endurance, exercise capacity, fatigue and health-related quality of life. We assessed the certainty of evidence using GRADE and included two Summary of findings tables.
MAIN RESULTS
We included four new studies in this update which overall randomised 178 adults with a mean age of 58 (standard deviation (SD) 8.2) years. Study sample size ranged from 20 to 60 participants and in three studies the proportion of men ranged from 52% to 82% (the fourth study was only available in abstract form). Three studies were from Europe: one in the UK and Norway; one in Belgium and one in Germany. The remaining study was in Canada. The types of primary cancer were head and neck (two studies), lung and pancreas (one study), and mixed (one study). We found two comparisons: exercise alone (strength-based exercise) compared to usual care (one study; 20 participants); and exercise (strength-based exercise/endurance exercise) as a component of a multimodal intervention (pharmacological, nutritional or educational (or a combination) interventions) compared with usual care (three studies, 158 participants). Studies had unclear and high risk of bias for most domains. Exercise plus usual care compared with usual care We found one study (20 participants). There was no clear evidence of a difference for lean body mass (8 weeks: MD 6.40 kg, 95% CI -2.30 to 15.10; very low-certainty evidence). For our secondary outcomes, all participants adhered to the exercise programme and no participant reported any adverse event during the study. There were no data for muscle strength and endurance, or maximal and submaximal exercise capacity. There was no clear evidence of a difference for either fatigue (4 to 20 scale, lower score was better) (8 weeks: MD -0.10, 95% CI -4.00 to 3.80; very low-certainty evidence) or health-related quality of life (0 to 104 scale, higher score was better) (8 weeks: MD 4.90, 95% CI -15.10 to 24.90; very low-certainty evidence). Multimodal intervention (exercise plus other interventions) plus usual care compared with usual care We found three studies but outcome data were only available for two studies. There was no clear evidence of a difference for lean body mass (6 weeks: MD 7.89 kg, 95% CI -9.57 to 25.35; 1 study, 44 participants; very low-certainty evidence; 12 weeks: MD -2.00, 95% CI -8.00 to 4.00; one study, 60 participants; very low-certainty evidence). For our secondary outcomes, there were no data reported on adherence to the exercise programme, endurance, or maximal exercise capacity. In one study (44 participants) there was no clear evidence of a difference for adverse events (patient episode report) (6 weeks: risk ratio (RR) 1.18, 95% CI 0.67 to 2.07; very low-certainty evidence). Another study assessed adverse events but reported no data and the third study did not assess this outcome. There was no clear evidence of a difference in muscle strength (6 weeks: MD 3.80 kg, 95% CI -2.87 to 10.47; 1 study, 44 participants; very low-certainty evidence; 12 weeks MD -5.00 kg, 95% CI -14.00 to 4.00; 1 study, 60 participants; very low-certainty evidence), submaximal exercise capacity (6 weeks: MD -16.10 m walked, 95% CI -76.53 to 44.33; 1 study, 44 participants; very low-certainty evidence; 12 weeks: MD -62.60 m walked, 95% CI -145.87 to 20.67; 1 study, 60 participants; very low-certainty evidence), fatigue (0 to 10 scale, lower score better) (6 weeks: MD 0.12, 95% CI -1.00 to 1.24; 1 study, 44 participants; very low-certainty evidence) or health-related quality of life (0 to 104 scale, higher score better) (12 weeks: MD -2.20, 95% CI -13.99 to 9.59; 1 study, 60 participants; very low-certainty evidence).
AUTHORS' CONCLUSIONS
The previous review identified no studies. For this update, our conclusions have changed with the inclusion of four studies. However, we are uncertain of the effectiveness, acceptability and safety of exercise for adults with cancer cachexia. Further high-quality randomised controlled trials are still required to test exercise alone or as part of a multimodal intervention to improve people's well-being throughout all phases of cancer care. We assessed the certainty of the body of evidence as very low, downgraded due to serious study limitations, imprecision and indirectness. We have very little confidence in the results and the true effect is likely to be substantially different from these. The findings of at least three more studies (one awaiting classification and two ongoing) are expected in the next review update.
Topics: Bias; Cachexia; Combined Modality Therapy; Exercise; Exercise Tolerance; Fatigue; Female; Head and Neck Neoplasms; Humans; Lung Neoplasms; Male; Middle Aged; Muscle Strength; Neoplasms; Pancreatic Neoplasms; Patient Compliance; Physical Endurance; Quality of Life; Randomized Controlled Trials as Topic; Thinness
PubMed: 33735441
DOI: 10.1002/14651858.CD010804.pub3 -
Journal of Intensive Care Medicine Oct 2022Inhaled pulmonary vasodilators (IPVD) have been previously studied in patients with non-coronavirus disease-19 (COVID-19) related acute respiratory distress syndrome... (Meta-Analysis)
Meta-Analysis
Inhaled pulmonary vasodilators (IPVD) have been previously studied in patients with non-coronavirus disease-19 (COVID-19) related acute respiratory distress syndrome (ARDS). The use of IPVD has been shown to improve the partial pressure of oxygen in arterial blood (PaO), reduce fraction of inspired oxygen (FiO) requirements, and ultimately increase PaO/FiO (P/F) ratios in ARDS patients. However, the role of IPVD in COVID-19 ARDS is still unclear. Therefore, we performed this meta-analysis to evaluate the role of IPVD in COVID-19 patients. Comprehensive literature search of PubMed, Embase, Web of Science and Cochrane Library databases from inception through April 22, 2022 was performed for all published studies that utilized IPVD in COVID-19 ARDS patients. The single arm studies and case series were combined for a 1-arm meta-analysis, and the 2-arm studies were combined for a 2-arm meta-analysis. Primary outcomes for the 1-arm and 2-arm meta-analyzes were change in pre- and post-IPVD P/F ratios and mortality, respectively. Secondary outcomes for the 1-arm meta-analysis were change in pre- and post-IPVD positive end-expiratory pressure (PEEP) and lung compliance, and for the 2-arm meta-analysis the secondary outcomes were need for endotracheal intubation and hospital length of stay (LOS). 13 single arm retrospective studies and 5 case series involving 613 patients were included in the 1-arm meta-analysis. 3 studies involving 640 patients were included in the 2-arm meta-analysis. The pre-IPVD P/F ratios were significantly lower compared to post-IPVD, but there was no significant difference between pre- and post-IPVD PEEP and lung compliance. The mortality rates, need for endotracheal intubation, and hospital LOS were similar between the IPVD and standard therapy groups. Although IPVD may improve oxygenation, our investigation showed no benefits in terms of mortality compared to standard therapy alone. However, randomized controlled trials are warranted to validate our findings.
Topics: COVID-19; Humans; Oxygen; Respiratory Distress Syndrome; Retrospective Studies; Vasodilator Agents
PubMed: 35915994
DOI: 10.1177/08850666221118271 -
The Cochrane Database of Systematic... Jun 2022Acute respiratory distress syndrome (ARDS) is a significant cause of hospitalisation and death in young children. Positioning and mechanical ventilation have been... (Review)
Review
BACKGROUND
Acute respiratory distress syndrome (ARDS) is a significant cause of hospitalisation and death in young children. Positioning and mechanical ventilation have been regularly used to reduce respiratory distress and improve oxygenation in hospitalised patients. Due to the association of prone positioning (lying on the abdomen) with sudden infant death syndrome (SIDS) within the first six months, it is recommended that young infants be placed on their back (supine). However, prone positioning may be a non-invasive way of increasing oxygenation in individuals with acute respiratory distress, and offers a more significant survival advantage in those who are mechanically ventilated. There are substantial differences in respiratory mechanics between adults and infants. While the respiratory tract undergoes significant development within the first two years of life, differences in airway physiology between adults and children become less prominent by six to eight years old. However, there is a reduced risk of SIDS during artificial ventilation in hospitalised infants. Thus, an updated review focusing on positioning for infants and young children with ARDS is warranted. This is an update of a review published in 2005, 2009, and 2012.
OBJECTIVES
To compare the effects of different body positions in hospitalised infants and children with acute respiratory distress syndrome aged between four weeks and 16 years.
SEARCH METHODS
We searched CENTRAL, which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE, Embase, and CINAHL from January 2004 to July 2021.
SELECTION CRITERIA
Randomised controlled trials (RCTs) or quasi-RCTs comparing two or more positions for the management of infants and children hospitalised with ARDS.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data from each study. We resolved differences by consensus, or referred to a third contributor to arbitrate. We analysed bivariate outcomes using an odds ratio (OR) and 95% confidence interval (CI). We analysed continuous outcomes using a mean difference (MD) and 95% CI. We used a fixed-effect model, unless heterogeneity was significant (I statistic > 50%), when we used a random-effects model.
MAIN RESULTS
We included six trials: four cross-over trials, and two parallel randomised trials, with 198 participants aged between 4 weeks and 16 years, all but 15 of whom were mechanically ventilated. Four trials compared prone to supine positions. One trial compared the prone position to good-lung dependent (where the person lies on the side of the healthy lung, e.g. if the right lung was healthy, they were made to lie on the right side), and independent (or non-good-lung independent, where the person lies on the opposite side to the healthy lung, e.g. if the right lung was healthy, they were made to lie on the left side) position. One trial compared good-lung independent to good-lung dependent positions. When the prone (with ventilators) and supine positions were compared, there was no information on episodes of apnoea or mortality due to respiratory events. There was no conclusive result in oxygen saturation (SaO MD 0.40 mmHg, 95% CI -1.22 to 2.66; 1 trial, 30 participants; very low certainty evidence); blood gases, PCO (MD 3.0 mmHg, 95% CI -1.93 to 7.93; 1 trial, 99 participants; low certainty evidence), or PO (MD 2 mmHg, 95% CI -5.29 to 9.29; 1 trial, 99 participants; low certainty evidence); or lung function (PaO/FiO ratio; MD 28.16 mmHg, 95% CI -9.92 to 66.24; 2 trials, 121 participants; very low certainty evidence). However, there was an improvement in oxygenation index (FiO% X M/ PaO) with prone positioning in both the parallel trials (MD -2.42, 95% CI -3.60 to -1.25; 2 trials, 121 participants; very low certainty evidence), and the cross-over study (MD -8.13, 95% CI -15.01 to -1.25; 1 study, 20 participants). Derived indices of respiratory mechanics, such as tidal volume, respiratory rate, and positive end-expiratory pressure (PEEP) were reported. There was an apparent decrease in tidal volume between prone and supine groups in a parallel study (MD -0.60, 95% CI -1.05 to -0.15; 1 study, 84 participants; very low certainty evidence). When prone and supine positions were compared in a cross-over study, there were no conclusive results in respiratory compliance (MD 0.07, 95% CI -0.10 to 0.24; 1 study, 10 participants); changes in PEEP (MD -0.70 cm HO, 95% CI -2.72 to 1.32; 1 study, 10 participants); or resistance (MD -0.00, 95% CI -0.05 to 0.04; 1 study, 10 participants). One study reported adverse events. There were no conclusive results for potential harm between groups in extubation (OR 0.57, 95% CI 0.13 to 2.54; 1 trial, 102 participants; very low certainty evidence); obstructions of the endotracheal tube (OR 5.20, 95% CI 0.24 to 111.09; 1 trial, 102 participants; very low certainty evidence); pressure ulcers (OR 1.00, 95% CI 0.41 to 2.44; 1 trial, 102 participants; very low certainty evidence); and hypercapnia (high levels of arterial carbon dioxide; OR 3.06, 95% CI 0.12 to 76.88; 1 trial, 102 participants; very low certainty evidence). One study (50 participants) compared supine positions to good-lung dependent and independent positions. There was no conclusive evidence that PaO was different between supine and good-lung dependent positioning (MD 3.44 mm Hg, 95% CI -23.12 to 30.00; 1 trial, 25 participants; very low certainty evidence). There was also no conclusive evidence for supine position and good-lung independent positioning (MD -2.78 mmHg, 95% CI -28.84, 23.28; 25 participants; very low certainty evidence); or between good-lung dependent and independent positioning (MD 6.22, 95% CI -21.25 to 33.69; 1 trial, 25 participants; very low certainty evidence). As most trials did not describe how possible biases were addressed, the potential for bias in these findings is unclear.
AUTHORS' CONCLUSIONS
Although included studies suggest that prone positioning may offer some advantage, there was little evidence to make definitive recommendations. There appears to be low certainty evidence that positioning improves oxygenation in mechanically ventilated children with ARDS. Due to the increased risk of SIDS with prone positioning and lung injury with artificial ventilation, it is recommended that hospitalised infants and children should only be placed in this position while under continuous cardiorespiratory monitoring.
Topics: Adult; Child; Child, Preschool; Humans; Infant; Infant, Newborn; Patient Positioning; Positive-Pressure Respiration; Respiration, Artificial; Respiratory Distress Syndrome; Sudden Infant Death
PubMed: 35661343
DOI: 10.1002/14651858.CD003645.pub4 -
The Cochrane Database of Systematic... Sep 2018This is an updated version of the original Cochrane Review published in the Cochrane Library 2013, Issue 9. Despite good evidence for the health benefits of regular... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an updated version of the original Cochrane Review published in the Cochrane Library 2013, Issue 9. Despite good evidence for the health benefits of regular exercise for people living with or beyond cancer, understanding how to promote sustainable exercise behaviour change in sedentary cancer survivors, particularly over the long term, is not as well understood. A large majority of people living with or recovering from cancer do not meet current exercise recommendations. Hence, reviewing the evidence on how to promote and sustain exercise behaviour is important for understanding the most effective strategies to ensure benefit in the patient population and identify research gaps.
OBJECTIVES
To assess the effects of interventions designed to promote exercise behaviour in sedentary people living with and beyond cancer and to address the following secondary questions: Which interventions are most effective in improving aerobic fitness and skeletal muscle strength and endurance? Which interventions are most effective in improving exercise behaviour amongst patients with different cancers? Which interventions are most likely to promote long-term (12 months or longer) exercise behaviour? What frequency of contact with exercise professionals and/or healthcare professionals is associated with increased exercise behaviour? What theoretical basis is most often associated with better behavioural outcomes? What behaviour change techniques (BCTs) are most often associated with increased exercise behaviour? What adverse effects are attributed to different exercise interventions?
SEARCH METHODS
We used standard methodological procedures expected by Cochrane. We updated our 2013 Cochrane systematic review by updating the searches of the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, Embase, AMED, CINAHL, PsycLIT/PsycINFO, SportDiscus and PEDro up to May 2018. We also searched the grey literature, trial registries, wrote to leading experts in the field and searched reference lists of included studies and other related recent systematic reviews.
SELECTION CRITERIA
We included only randomised controlled trials (RCTs) that compared an exercise intervention with usual care or 'waiting list' control in sedentary people over the age of 18 with a homogenous primary cancer diagnosis.
DATA COLLECTION AND ANALYSIS
In the update, review authors independently screened all titles and abstracts to identify studies that might meet the inclusion criteria, or that could not be safely excluded without assessment of the full text (e.g. when no abstract is available). We extracted data from all eligible papers with at least two members of the author team working independently (RT, LS and RG). We coded BCTs according to the CALO-RE taxonomy. Risk of bias was assessed using the Cochrane's tool for assessing risk of bias. When possible, and if appropriate, we performed a fixed-effect meta-analysis of study outcomes. If statistical heterogeneity was noted, a meta-analysis was performed using a random-effects model. For continuous outcomes (e.g. cardiorespiratory fitness), we extracted the final value, the standard deviation (SD) of the outcome of interest and the number of participants assessed at follow-up in each treatment arm, to estimate the standardised mean difference (SMD) between treatment arms. SMD was used, as investigators used heterogeneous methods to assess individual outcomes. If a meta-analysis was not possible or was not appropriate, we narratively synthesised studies. The quality of the evidence was assessed using the GRADE approach with the GRADE profiler.
MAIN RESULTS
We included 23 studies in this review, involving a total of 1372 participants (an addition of 10 studies, 724 participants from the original review); 227 full texts were screened in the update and 377 full texts were screened in the original review leaving 35 publications from a total of 23 unique studies included in the review. We planned to include all cancers, but only studies involving breast, prostate, colorectal and lung cancer met the inclusion criteria. Thirteen studies incorporated a target level of exercise that could meet current recommendations for moderate-intensity aerobic exercise (i.e.150 minutes per week); or resistance exercise (i.e. strength training exercises at least two days per week).Adherence to exercise interventions, which is crucial for understanding treatment dose, is still reported inconsistently. Eight studies reported intervention adherence of 75% or greater to an exercise prescription that met current guidelines. These studies all included a component of supervision: in our analysis of BCTs we designated these studies as 'Tier 1 trials'. Six studies reported intervention adherence of 75% or greater to an aerobic exercise goal that was less than the current guideline recommendations: in our analysis of BCTs we designated these studies as 'Tier 2 trials.' A hierarchy of BCTs was developed for Tier 1 and Tier 2 trials, with programme goal setting, setting of graded tasks and instruction of how to perform behaviour being amongst the most frequent BCTs. Despite the uncertainty surrounding adherence in some of the included studies, interventions resulted in improvements in aerobic exercise tolerance at eight to 12 weeks (SMD 0.54, 95% CI 0.37 to 0.70; 604 participants, 10 studies; low-quality evidence) versus usual care. At six months, aerobic exercise tolerance was also improved (SMD 0.56, 95% CI 0.39 to 0.72; 591 participants; 7 studies; low-quality evidence).
AUTHORS' CONCLUSIONS
Since the last version of this review, none of the new relevant studies have provided additional information to change the conclusions. We have found some improved understanding of how to encourage previously inactive cancer survivors to achieve international physical activity guidelines. Goal setting, setting of graded tasks and instruction of how to perform behaviour, feature in interventions that meet recommendations targets and report adherence of 75% or more. However, long-term follow-up data are still limited, and the majority of studies are in white women with breast cancer. There are still a considerable number of published studies with numerous and varied issues related to high risk of bias and poor reporting standards. Additionally, the meta-analyses were often graded as consisting of low- to very low-certainty evidence. A very small number of serious adverse effects were reported amongst the studies, providing reassurance exercise is safe for this population.
Topics: Breast Neoplasms; Cancer Survivors; Colorectal Neoplasms; Exercise; Exercise Tolerance; Female; Habits; Health Promotion; Humans; Male; Muscle Strength; Neoplasms; Patient Compliance; Prostatic Neoplasms; Randomized Controlled Trials as Topic; Sedentary Behavior; Time Factors
PubMed: 30229557
DOI: 10.1002/14651858.CD010192.pub3 -
PloS One 2019Primary health professionals are well positioned to support the delivery of patient self-management in an evidence-based, structured capacity. A need exists to better...
BACKGROUND
Primary health professionals are well positioned to support the delivery of patient self-management in an evidence-based, structured capacity. A need exists to better understand the active components required for effective self-management support, how these might be delivered within primary care, and the training and system changes that would subsequently be needed.
OBJECTIVES
(1) To examine self-management support interventions in primary care on health outcomes for a wide range of diseases compared to usual standard of care; and (2) To identify the effective strategies that facilitate positive clinical and humanistic outcomes in this setting.
METHOD
A systematic review of randomized controlled trials evaluating self-management support interventions was conducted following the Cochrane handbook & PRISMA guidelines. Published literature was systematically searched from inception to June 2019 in PubMed, Scopus and Web of Science. Eligible studies assessed the effectiveness of individualized interventions with follow-up, delivered face-to-face to adult patients with any condition in primary care, compared with usual standard of care. Matrices were developed that mapped the evidence and components for each intervention. The methodological quality of included studies were appraised.
RESULTS
6,510 records were retrieved. 58 studies were included in the final qualitative synthesis. Findings reveal a structured patient-provider exchange is required in primary care (including a one-on-one patient-provider consultation, ongoing follow up and provision of self-help materials). Interventions should be tailored to patient needs and may include combinations of strategies to improve a patient's disease or treatment knowledge; independent monitoring of symptoms, encouraging self-treatment through a personalized action plan in response worsening symptoms or exacerbations, psychological coping and stress management strategies, and enhancing responsibility in medication adherence and lifestyle choices. Follow-up may include tailored feedback, monitoring of progress with respect to patient set healthcare goals, or honing problem-solving and decision-making skills. Theoretical models provided a strong base for effective SMS interventions. Positive outcomes for effective SMS included improvements in clinical indicators, health-related quality of life, self-efficacy (confidence to self-manage), disease knowledge or control. An SMS model has been developed which sets the foundation for the design and evaluation of practical strategies for the construct of self-management support interventions in primary healthcare practice.
CONCLUSIONS
These findings provide primary care professionals with evidence-based strategies and structure to deliver SMS in practice. For this collaborative partnership approach to be more widely applied, future research should build on these findings for optimal SMS service design and upskilling healthcare providers to effectively support patients in this collaborative process.
Topics: Adaptation, Psychological; Depression; Diabetes Mellitus, Type 2; Health Behavior; Humans; Medication Adherence; Practice Guidelines as Topic; Primary Health Care; Pulmonary Disease, Chronic Obstructive; Quality of Life; Self-Management
PubMed: 31369582
DOI: 10.1371/journal.pone.0220116