The modifiable biopsychosocial drivers of psychological distress for adolescents with asthma: Implications for Clinical Care.

PURPOSE: Overwhelming distress exceeds the capacity of healthy coping strategies to feel better using healthy coping strategies alone, resulting in the use of unhealthy coping strategies. Unhealthy coping strategies may exacerbate asthma symptoms and asthma can contribute to overwhelming distress. This study aimed to review the modifiable drivers of overwhelming distress in adolescents with asthma. METHODS: The biopsychosocial drivers of psychological distress for adolescents with asthma were explored within the domains of the modifiable biopsychosocial model of health and wellbeing. RESULTS: Asthma in adolescents is associated with problems in the domains of environment, developmental outcomes, sense of belonging, health behaviours, coping, and treatment of illness. CONCLUSIONS: The relationship between asthma and psychological distress highlights the need for holistic treatment of asthma. Further research is needed to establish causation between variables and to investigate whether interventions that address either asthma symptoms or biopsychosocial drivers of distress can improve both factors.

Pharmacological and surgical interventions for the treatment of gastro-oesophageal reflux in adults and children with asthma.

BACKGROUND: Asthma and gastro-oesophageal reflux disease (GORD) are common medical conditions that frequently co-exist. GORD has been postulated as a trigger for asthma; however, evidence remains conflicting. Proposed mechanisms by which GORD causes asthma include direct airway irritation from micro-aspiration and vagally mediated oesophagobronchial reflux. Furthermore, asthma might precipitate GORD. Thus a temporal association between the two does not establish that GORD triggers asthma. OBJECTIVES: To evaluate the effectiveness of GORD treatment in adults and children with asthma, in terms of its benefits for asthma. SEARCH METHODS: The Cochrane Airways Group Specialised Register, CENTRAL, MEDLINE, Embase, reference lists of articles, and online clinical trial databases were searched. The most recent search was conducted on 23 June 2020. SELECTION CRITERIA: We included randomised controlled trials comparing treatment of GORD in adults and children with a diagnosis of both asthma and GORD versus no treatment or placebo. DATA COLLECTION AND ANALYSIS: A combination of two independent review authors extracted study data and assessed trial quality. The primary outcome of interest for this review was acute asthma exacerbation as reported by trialists. MAIN RESULTS: The systematic search yielded a total of 3354 citations; 23 studies (n = 2872 participants) were suitable for inclusion. Included studies reported data from participants in 25 different countries across Europe, North and South America, Asia, Australia, and the Middle East. Participants included in this review had moderate to severe asthma and a diagnosis of GORD and were predominantly adults presenting to a clinic for treatment. Only two studies assessed effects of intervention on children, and two assessed the impact of surgical intervention. The remainder were concerned with medical intervention using a variety of dosing protocols. There was an uncertain reduction in the number of participants experiencing one or more moderate/severe asthma exacerbations with medical treatment for GORD (odds ratio 0.53, 95% confidence interval (CI) 0.17 to 1.63; 1168 participants, 2 studies; low-certainty evidence). None of the included studies reported data related to the other primary outcomes for this review: hospital admissions, emergency department visits, and unscheduled doctor visits. Medical treatment for GORD probably improved forced expiratory volume in one second (FEV1) by a small amount (mean difference (MD) 0.10 L, 95% CI 0.05 to 0.15; 1333 participants, 7 studies; moderate-certainty evidence) as well as use of rescue medications (MD -0.71 puffs per day, 95% CI -1.20 to -0.22; 239 participants, 2 studies; moderate-certainty evidence). However, the benefit of GORD treatment for morning peak expiratory flow rate was uncertain (MD 6.02 L/min, 95% CI 0.56 to 11.47; 1262 participants, 5 studies). It is important to note that these mean improvements did not reach clinical importance. The benefit of GORD treatment for outcomes synthesised narratively including benefits of treatment for asthma symptoms, quality of life, and treatment preference was likewise uncertain. Data related to adverse events with intervention were generally underreported by the included studies, and those that were available indicated similar rates regardless of allocation to treatment or placebo. AUTHORS' CONCLUSIONS: Effects of GORD treatment on the primary outcomes of number of people experiencing one or more exacerbations and hospital utilisation remain uncertain. Medical treatment for GORD in people with asthma may provide small benefit for a number of secondary outcomes related to asthma management. This review determined with moderate certainty that with treatment, lung function measures improved slightly, and use of rescue medications for asthma control was reduced. Further, evidence is insufficient to assess results in children, or to compare surgery versus medical therapy.

A systematic review and meta-analysis of psychological interventions to improve mental wellbeing.

Our current understanding of the efficacy of psychological interventions in improving mental states of wellbeing is incomplete. This study aimed to overcome limitations of previous reviews by examining the efficacy of distinct types of psychological interventions, irrespective of their theoretical underpinning, and the impact of various moderators, in a unified systematic review and meta-analysis. Four-hundred-and-nineteen randomized controlled trials from clinical and non-clinical populations (n = 53,288) were identified for inclusion. Mindfulness-based and multi-component positive psychological interventions demonstrated the greatest efficacy in both clinical and non-clinical populations. Meta-analyses also found that singular positive psychological interventions, cognitive and behavioural therapy-based, acceptance and commitment therapy-based, and reminiscence interventions were impactful. Effect sizes were moderate at best, but differed according to target population and moderator, most notably intervention intensity. The evidence quality was generally low to moderate. While the evidence requires further advancement, the review provides insight into how psychological interventions can be designed to improve mental wellbeing.

Pharmacological interventions for the treatment of psychological distress in patients with asthma: a systematic review and meta-analysis.

Objective: To evaluate the effectiveness and safety of pharmacological interventions for the treatment of psychological distress in people with asthma.Data sources: Electronic searches were performed in Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, PubMed/Medline, Embase, PsycInfo, Health Technology Assessment Database and Web of Science (inception to April 2019).Study selections: Included studies were randomized controlled trials (RCT) or controlled clinical trials investigating the effect of pharmacological interventions for psychological distress in people with asthma. Records were screened and data extracted by two independent authors into standardized pilot-tested extraction templates. Data was analyzed according to standard Cochrane methodology and entered into Review Manager Software version 5.3.Results: From 5,689 studies, six RCTs (n = 215) met inclusion criteria and were included in the systematic review, of which four studies were included in the meta-analysis. A meta-analysis of four studies (n = 158) indicated no evidence of an effect for selective serotonin reuptake inhibitors (Citalopram or Escitalopram) on reduction of psychological distress in adult patients with asthma. Similarly, antiepileptic medication (Levetiracetam) was no better than placebo in the treatment of psychological distress in people with asthma. Adverse events were poorly reported across all studies but were slightly increased among intervention participants compared to control participants.Conclusions: There was great heterogeneity between studies and overall poor methodological quality providing insufficient evidence to make recommendations for or against the use of pharmacotherapy in asthma patients with psychological distress. Further confirmatory trials are warranted to make recommendations for clinical practice.

The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial.

INTRODUCTION: Smoking is a leading cause of premature deaths globally. The health benefits of smoking cessation are many. However, majority of quit attempts are unsuccessful. One way to potentially improve success rates is to evaluate new combinations of existing smoking cessation therapies that may work synergistically to decrease the intensity of withdrawal symptoms and cravings. AIMS: To evaluate the feasibility, efficacy and safety of the combination of varenicline and nicotine replacement therapy (NRT) lozenges versus varenicline alone in assisting hospitalised smokers to quit. METHODS AND ANALYSIS: This is a multicentre, randomised, placebo-controlled trial. Adults with a history of smoking ≥10 cigarettes per day on average in the 4 weeks prior to their hospitalisation will be recruited. Participants will be randomly assigned to either the intervention group and will receive varenicline and NRT lozenges, or the control group and will receive varenicline and placebo lozenges. All participants will be actively referred to behavioural support from telephone Quitline. Participants are followed up at 1 and 3 weeks and 3, 6 and 12 months from the start of treatment. The primary outcome is carbon monoxide validated prolonged abstinence from 2 weeks to 6 months after treatment initiation. Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others. According to the Russell Standard, all randomised participants will be accounted for in the primary intention-to-treat analysis. ETHICS AND DISSEMINATION: The trial will be conducted in compliance with the protocol, the principles of Good Clinical Practice, the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (updated 2015) and the Australian Code for the Responsible Conduct of Research (2018). Approval will be sought from the Human Ethics Committees of all the participating hospitals and the university. Written informed consent will be obtained from each participant at the time of recruitment. TRIAL REGISTRATION NUMBER: Australia New Zealand Clinical Trials Registry (ACTRN12618001792213).

Oxygen therapy in the pre-hospital setting for acute exacerbations of chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a global leading cause of morbidity and mortality, characterised by acute deterioration in symptoms. During these exacerbations, people are prone to developing alveolar hypoventilation, which may be partly caused by the administration of high inspired oxygen concentrations. OBJECTIVES: To determine the effect of different inspired oxygen concentrations ("high flow" compared to "controlled") in the pre-hospital setting (prior to casualty/emergency department) on outcomes for people with acute exacerbations of COPD (AECOPD). SEARCH METHODS: The Cochrane Airways Group Specialised Register, reference lists of articles and online clinical trial databases were searched. Authors of identified randomised controlled trials (RCTs) were also contacted for details of other relevant published and unpublished studies. The most recent search was conducted on 16 September 2019. SELECTION CRITERIA: We included RCTs comparing oxygen therapy at different concentrations or oxygen therapy versus placebo in the pre-hospital setting for treatment of AECOPD. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. The primary outcome was all-cause and respiratory-related mortality. MAIN RESULTS: The search identified a total of 824 citations; one study was identified for inclusion and two studies are awaiting classification. The 214 participants involved in the included study were adults with AECOPD, receiving treatment by paramedics en route to hospital. The mean age of participants was 68 years. A reduction in pre/in-hospital mortality was observed in favour of the titrated oxygen group (two deaths in the titrated oxygen group compared to 11 deaths in the high-flow control arm; risk ratio (RR) 0.22, 95% confidence interval (CI) 0.05 to 0.97; 214 participants). This translates to an absolute effect of 94 per 1000 (high-flow oxygen) compared to 21 per 1000 (titrated oxygen), and a number needed to treat for an additional beneficial outcome (NNTB) of 14 (95% CI 12 to 355) with titrated oxygen therapy. Other than mortality, no other adverse events were reported in the included study. Wide confidence intervals were observed between groups for arterial blood gas (though this may be confounded by protocol infidelity in the included study for this outcome measure), treatment failure requiring invasive or non-invasive ventilation or hospital utilisation. No data were reported for quality of life, lung function or dyspnoea. Risk of bias within the included study was largely unclear, though there was high risk of bias in domains relating to performance and attrition bias. We judged the evidence to be of low certainty, according to GRADE criteria. AUTHORS' CONCLUSIONS: The one included study found a reduction in pre/in-hospital mortality for the titrated oxygen arm compared to the high-flow control arm. However, the paucity of evidence somewhat limits the reliability of these findings and generalisability to other settings. There is a need for robust, well-designed RCTs to further investigate the effect of oxygen therapies in the pre-hospital setting for people with AECOPD.

Community pharmacy personnel interventions for smoking cessation.

BACKGROUND: Community pharmacists could provide effective smoking cessation treatment because they offer easy access to members of the community. They are well placed to provide both advice on the correct use of smoking cessation products and behavioural support to aid smoking cessation. OBJECTIVES: To assess the effectiveness of interventions delivered by community pharmacy personnel to assist people to stop smoking, with or without concurrent use of pharmacotherapy. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group Specialised Register, along with clinicaltrials.gov and the ICTRP, for smoking cessation studies conducted in a community pharmacy setting, using the search terms pharmacist* or pharmacy or pharmacies. Date of the most recent search: January 2019. SELECTION CRITERIA: Randomised controlled trials of interventions delivered by community pharmacy personnel to promote smoking cessation amongst their clients who were smokers, compared with usual pharmacy support or any less intensive programme. The main outcome measure was smoking cessation rates at six months or more after the start of the intervention. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane for study screening, data extraction and management. We conducted a meta-analysis using a Mantel-Haenszel random-effects model to generate risk ratios (RRs) and 95% confidence intervals (CIs). MAIN RESULTS: We identified seven studies including 1774 participants. We judged three studies to be at high risk of bias and four to be at unclear risk. Each study provided face-to-face behavioural support delivered by pharmacy staff, and required pharmacy personnel training. Typically such programmes comprised support starting before quit day and continuing with weekly appointments for several weeks afterwards. Comparators were either minimal or less intensive behavioural support for smoking cessation, typically comprising a few minutes of one-off advice on how to quit. Participants in both intervention and control arms received equivalent smoking cessation pharmacotherapy in all but one study. All studies took place in high-income countries, and recruited participants visiting pharmacies. We pooled six studies of 1614 participants and detected a benefit of more intensive behavioural smoking cessation interventions delivered by community pharmacy personnel compared with less intensive cessation interventions at longest follow-up (RR 2.30, 95% CI 1.33 to 3.97; I2 = 54%; low-certainty evidence). AUTHORS' CONCLUSIONS: Community pharmacists can provide effective behavioural support to people trying to stop smoking. However, this conclusion is based on low-certainty evidence, limited by risk of bias and imprecision. Further research could change this conclusion.

Short-acting bronchodilators for the management of acute exacerbations of chronic obstructive pulmonary disease in the hospital setting: systematic review.

BACKGROUND: Currently, there is a lack of guidelines for the use of short-acting bronchodilators (SABD) in people admitted to hospital for acute exacerbation of chronic obstructive pulmonary disease (AECOPD), despite routine use in practice and risk of cardiac adverse events. AIM: To review the evidence that underpins use and optimal dose, in terms of risk versus benefit, of SABD for inpatient management of AECOPD and collate the results for future guidelines. METHODS: Medline, Embase, the Cochrane Central Register of Controlled Trials, clinicaltrials.gov and International Clinical Trials Registry Platform were searched (inception to November 2017) for published and ongoing studies. Included studies were randomised controlled trials or controlled clinical trials investigating the effect of SABD (ß2-agonist and/or ipratropium) on inpatients with a diagnosis of AECOPD. This review was undertaken in accordance with PRISMA guidelines and a pre-defined protocol. Due to heterogeneous methodologies, meta-analysis was not possible so the results were synthesised qualitatively. RESULTS: Of 1378 studies identified, 10 met inclusion criteria. Narrative synthesis of 10 studies revealed no significant differences in most outcomes of interest relative to dose, delivery via inhaler or nebuliser, and type of ß2-agonist used. However, some evidence demonstrated significantly increased cardiac side effects with increased dosage of ß2-agonist (45% versus 24%), P<0.05). CONCLUSION: This review identified a paucity of methodologically rigorous evidence evaluating use of SABD among AECOPD. The available evidence did not identify any additional benefits for participants receiving higher doses of short-acting ß2-agonists compared to lower doses, or based on type of delivery method or ß2-agonists used. However, there was a small increase in some adverse events for participants using higher doses of ß2-agonists.

Influenza vaccine for chronic obstructive pulmonary disease (COPD).

BACKGROUND: Influenza vaccinations are currently recommended in the care of people with COPD, but these recommendations are based largely on evidence from observational studies, with very few randomised controlled trials (RCTs) reported. Influenza infection causes excess morbidity and mortality in people with COPD, but there is also the potential for influenza vaccination to cause adverse effects, or not to be cost effective. OBJECTIVES: To determine whether influenza vaccination in people with COPD reduces respiratory illness, reduces mortality, is associated with excess adverse events, and is cost effective. SEARCH METHODS: We searched the Cochrane Airways Trials Register, two clinical trials registries, and reference lists of articles. A number of drug companies we contacted also provided references. The latest search was carried out in December 2017. SELECTION CRITERIA: RCTs that compared live or inactivated virus vaccines with placebo, either alone or with another vaccine, in people with COPD. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data. All entries were double-checked. We contacted study authors and drug companies for missing information. We used standard methods expected by Cochrane. MAIN RESULTS: We included 11 RCTs with 6750 participants, but only six of these included people with COPD (2469 participants). The others were conducted on elderly and high-risk individuals, some of whom had chronic lung disease. Interventions compared with placebo were inactivated virus injections and live attenuated intranasal virus vaccines. Some studies compared intra-muscular inactivated vaccine and intranasal live attenuated vaccine with intra-muscular inactivated vaccine and intranasal placebo. Studies were conducted in the UK, USA and Thailand.Inactivated vaccine reduced the total number of exacerbations per vaccinated participant compared with those who received placebo (mean difference (MD) -0.37, 95% confidence interval (CI) -0.64 to -0.11; P = 0.006; two RCTs, 180 participants; low quality evidence). This was due to the reduction in 'late' exacerbations, occurring after three or four weeks (MD -0.39, 95% CI -0.61 to -0.18; P = 0.0004; two RCTs, 180 participants; low quality evidence). Both in people with COPD, and in older people (only a minority of whom had COPD), there were significantly more local adverse reactions in people who had received the vaccine, but the effects were generally mild and transient.There was no evidence of an effect of intranasal live attenuated virus when this was added to inactivated intramuscular vaccination.Two studies evaluating mortality for influenza vaccine versus placebo were too small to have detected any effect on mortality. However, a large study (N=2215) noted that there was no difference in mortality when adding live attenuated virus to inactivated virus vaccination, AUTHORS' CONCLUSIONS: It appeared, from the limited number of RCTs we were able to include, all of which were more than a decade old, that inactivated vaccine reduced exacerbations in people with COPD. The size of effect was similar to that seen in large observational studies, and was due to a reduction in exacerbations occurring three or more weeks after vaccination, and due to influenza. There was a mild increase in transient local adverse effects with vaccination, but no evidence of an increase in early exacerbations. Addition of live attenuated virus to the inactivated vaccine was not shown to confer additional benefit.

Asthma Bronchiale and Exercise-Induced Bronchoconstriction.

Exercising regularly has a wide range of beneficial health effects; in particular, it has been well documented to help in the management of chronic illnesses including asthma. However, in some individuals, exertion can also trigger an exacerbation of asthmatic episodes and subsequent acute attacks of breathlessness, coughing, tightness of the chest and wheezing. This physiological process is called exercise-induced bronchoconstriction (EIB) whereby post-exercise forced expiratory volume in 1 s is reduced by 10-15% from baseline. While EIB is highly prevalent in asthmatics and presents with similar respiratory symptoms, asthma and EIB are not mutually exclusive. The aim of this review is to present a broad overview of both conditions in order to enhance the understanding of the similarities and differences distinguishing them as two separate entities. The pathophysiology and mechanisms underlying asthma are well described with research now focussing on defining phenotypes for targeted management strategies. Conversely, the mechanistic understanding of EIB remains largely under-described. Diagnostic pathways for both are established and similar, as are pharmacologic and non-pharmacologic treatments and management approaches, which have enhanced success with early detection. Given the potential for exacerbation of asthma, exercise avoidance is common but counterproductive as current evidence indicates that it is well tolerated and improves quality of life. Literature supporting the benefit of exercise for EIB sufferers is at present favourable, yet extremely limited; therefore, future research should be directed in this area as well as towards further developing the understanding of the pathophysiology and mechanisms underpinning both EIB and asthma.