scholarly journals Four-week daily airway clearance using oscillating positive-end expiratory pressure versus autogenic drainage in bronchiectasis patients: a randomised controlled trial

2021 ◽  
pp. 00426-2021
Author(s):  
Galit Livnat ◽  
Naama Yaari ◽  
Nili Stein ◽  
Lea Bentur ◽  
Moneera Hanna ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Forced Expiratory Volume ◽  
Treatment Burden ◽  
Ventilation Inhomogeneity ◽  
Airway Clearance ◽  
Sputum Volume ◽  
Randomised Controlled

BackgroundAirway clearance (AC) is a fundamental component of bronchiectasis care. Lung clearance index (LCI) is a measurement of ventilation inhomogeneity. Its responsiveness to long-term AC is unknown. We aimed to compare two methods of daily AC over four weeks: autogenic drainage (AD) and oscillating positive airway pressure (oPEP), and to to determine effects of AC on LCI and clinical outcomes.MethodsAdults with bronchiectasis naive to airway clearance were randomised to daily AC with either AD or oPEP. Difference in LCI as primary outcome, spirometry, sputum volume and purulence, and quality of life were evaluated at randomisation and after four weeks of AC.ResultsFifty-one patients (32 women, 19 men, mean age 66.2±12.8 years) were randomised and 49 completed the study (25 AD, 24 oPEP). The LCI and forced expiratory volume in the first second (FEV1) did not change between visits between groups (difference between groups 0.02), nor between visits in either group. Sputum quantity decreased in 12/24 (50%) of the oPEP group, and in 6/25 (24%) of the AD group (p=0.044). The “treatment burden” worsened or was unchanged in 70% of participants randomised to AD and 55% randomised to oPEP (p=0.038).ConclusionSputum quantity decreased in more participants randomised to oPEP group after one month of daily AC, with a better treatment burden. The effects of four weeks of AC on LCI were not significant in either treatment group.

scholarly journals Effects of training on quality of peer review: randomised controlled trial

BMJ ◽  
2004 ◽  
Vol 328 (7441) ◽  
pp. 673 ◽  
Author(s):  
Sara Schroter ◽  
Nick Black ◽  
Stephen Evans ◽  
James Carpenter ◽  
Fiona Godlee ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Review ◽  
Controlled Trial ◽  
Control Group ◽  
Group Score ◽  
The Difference ◽  
Randomised Controlled ◽  
Quality Instrument

AbstractObjective To determine the effects of training on the quality of peer review.Design Single blind randomised controlled trial with two intervention groups receiving different types of training plus a control group.Setting and participants Reviewers at a general medical journal.Interventions Attendance at a training workshop or reception of a self taught training package focusing on what editors want from reviewers and how to critically appraise randomised controlled trials.Main outcome measures Quality of reviews of three manuscripts sent to reviewers at four to six monthly intervals, evaluated using the validated review quality instrument; number of deliberate major errors identified; time taken to review the manuscripts; proportion recommending rejection of the manuscripts.Results Reviewers in the self taught group scored higher in review quality after training than did the control group (score 2.85 v 2.56; difference 0.29, 95% confidence interval 0.14 to 0.44; P = 0.001), but the difference was not of editorial significance and was not maintained in the long term. Both intervention groups identified significantly more major errors after training than did the control group (3.14 and 2.96 v 2.13; P < 0.001), and this remained significant after the reviewers' performance at baseline assessment was taken into account. The evidence for benefit of training was no longer apparent on further testing six months after the interventions. Training had no impact on the time taken to review the papers but was associated with an increased likelihood of recommending rejection (92% and 84% v 76%; P = 0.002).Conclusions Short training packages have only a slight impact on the quality of peer review. The value of longer interventions needs to be assessed.

A Tablet ‐ Based Intervention for Activating Nursing Home Residents with Dementia: Results from a Cluster-Randomised Controlled Trial

2020 ◽  
Author(s):  
Julie Lorraine O'Sullivan ◽  
Sonia Lech ◽  
Paul Gellert ◽  
Ulrike Grittner ◽  
Jan-Niklas Voigt-Antons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Nursing Home ◽  
Nursing Homes ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Cluster Randomised Controlled Trial ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background: Non-pharmacological interventions (NPI) can improve cognitive and non-cognitive symptoms in nursing home residents living with dementia. However, delivery of suitable NPI can be challenging in everyday nursing home settings. Internet and communication technologies (ICT) may be promising tools for supporting NPI delivery in nursing homes. Methods: A two-arm cluster-randomised controlled trial was conducted to investigate global and momentary effects of a novel ICT-based NPI for nursing home residents with dementia. Ten nursing homes were randomly allocated to the tablet-based intervention (TBI) or conventional activity sessions (CAS) group (each with five nursing homes) between April 2016 and May 2017. A total of N = 162 participants received either regular TBI (n = 80) or CAS (n = 82) over a period of eight weeks. Linear mixed models were used to analyse group differences regarding the primary outcome apathy (AES-I), and secondary outcomes quality of life (QOL-AD, QUALIDEM), neuropsychiatric (NPI-NH, psychotropic medication) and depressive symptoms (GDS). Ecological Momentary Assessments (EMA) of quality of life were also conducted in both groups before and after each activity session.Results: No significant group difference in the change of apathy (AES-I score, primary outcome) was found post intervention (mean group difference: B = .19; 95% CI: -3.90 to 4.28, p = .93). Regarding secondary outcomes, a reduction of psychotropic medication was found for TBI compared to CAS (B = .42; 95% CI: .15 to .69, p < .01). Further analyses revealed a post-intervention improvement of informant-rated quality of life across both groups (B = 3.69; 95% CI: .68 to 6.69, p = .02). Analysis of EMA also rendered short-term post-session improvements of quality of life in the CAS group (B = .43; 95% CI: .30 to .57, p < .001). Conclusions: These findings suggest that NPI involving individually tailored activities have a beneficial impact on quality of life in nursing home residents with dementia. Although we found no clear advantage of TBI compared to CAS, ICT have the potential to support NPI delivery and facilitate regular assessments of fluctuating momentary states in nursing home residents with dementia. Trial registration: The trial was retrospectively registered with the ISRCTN registry (Trial registration number: ISRCTN98947160) on 01/09/2016 http://www.isrctn.com/ISRCTN98947160.

scholarly journals Evaluation of a positive psychotherapy group intervention for people with psychosis: pilot randomised controlled trial

2015 ◽  
Vol 25 (3) ◽  
pp. 235-246 ◽  
Author(s):  
Beate Schrank ◽  
Tamsin Brownell ◽  
Zivile Jakaite ◽  
Charley Larkin ◽  
Francesca Pesola ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Group Intervention ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Esteem ◽  
Positive Psychotherapy ◽  
Main Effect ◽  
Randomised Controlled

Aims.Third-wave psychological interventions have gained relevance in mental health service provision but their application to people with psychosis is in its infancy and interventions targeting wellbeing in psychosis are scarce. This study tested the feasibility and preliminary effectiveness of positive psychotherapy adapted for people with psychosis (WELLFOCUS PPT) to improve wellbeing.Methods.WELLFOCUS PPT was tested as an 11-week group intervention in a convenience sample of people with psychosis in a single centre randomised controlled trial (ISRCTN04199273) involving 94 people with psychosis. Patients were individually randomised in blocks to receive either WELLFOCUS PPT in addition to treatment as usual (TAU), or TAU only. Assessments took place before randomisation and after the therapy. The primary outcome was wellbeing (Warwick-Edinburgh Mental Well-Being Scale, WEMWBS). Secondary outcomes included symptoms (Brief Psychiatric Rating Scale), depression (Short Depression-Happiness Scale), self-esteem, empowerment, hope, sense of coherence, savouring beliefs and functioning, as well as two alternative measures of wellbeing (the Positive Psychotherapy Inventory and Quality of Life). Intention-to-treat analysis was performed. This involved calculating crude changes and paired-sample t-tests for all variables, as well as ANCOVA and Complier Average Causal Effect (CACE) Analysis to estimate the main effect of group on all outcomes.Results.The intervention and trial procedures proved feasible and well accepted. Crude changes between baseline and follow-up showed a significant improvement in the intervention group for wellbeing according to all three concepts assessed (i.e., WEMWBS, Positive Psychotherapy Inventory and Quality of Life), as well as for symptoms, depression, hope, self-esteem and sense of coherence. No significant changes were observed in the control group. ANCOVA showed no main effect on wellbeing according to the primary outcome scale (WEMWBS) but significant effects on symptoms (p = 0.006, ES = 0.42), depression (p = 0.03, ES = 0.38) and wellbeing according to the Positive Psychotherapy Inventory (p = 0.02, ES = 0.30). Secondary analysis adapting for therapy group further improved the results for symptom reduction (p = 0.004, ES = 0.43) and depression (p = 0.03, ES = 0.41) but did not lead to any more outcomes falling below the p = 0.05 significance level. CACE analysis showed a non-significant positive association between the intervention and WEMWBS scores at follow-up (b = 0.21, z = 0.9, p = 0.4).Conclusions.This study provides initial evidence on the feasibility of WELLFOCUS PPT in people with psychosis, positively affecting symptoms and depression. However, more work is needed to optimise its effectiveness. Future research might evaluate positive psychotherapy as a treatment for comorbid depression in psychosis, and consider alternative measurements of wellbeing.

scholarly journals Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

2021 ◽  
Author(s):  
Jan Maláska ◽  
Jan Stašek ◽  
František Duška ◽  
Martin Balík ◽  
Jan Máca ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Primary Objective ◽  
Efficacy And Safety ◽  
Open Label ◽  
Parallel Group ◽  
Secondary Objective ◽  
Randomised Controlled

Abstract ObjectivesThe primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days.

scholarly journals Effectiveness and cost-effectiveness of a structured social coaching intervention for people with psychosis (SCENE): protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e050627
Author(s):  
Domenico Giacco ◽  
Agnes Chevalier ◽  
Megan Patterson ◽  
Thomas Hamborg ◽  
Rianna Mortimer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Social Activities ◽  
Social Contacts ◽  
Coaching Intervention ◽  
Randomised Controlled

IntroductionPeople with psychosis tend to have smaller social networks than both people in the general population and other people with long-term health conditions. Small social networks are associated with poor quality of life. Preliminary evidence suggests that coaching patients to increase their social contacts may be effective. In this study, we assessed whether structured social coaching improves the quality of life of patients with psychosis (primary outcome) compared with an active control group, receiving information on local social activities.Methods and analysisA structured social coaching intervention was developed based on the literature and refined through stakeholder involvement. It draws on principles from motivational interviewing, solution focused therapy and structured information giving. It is provided over a 6-month period and can be delivered by a range of different mental health professionals. Its effectiveness and cost-effectiveness are assessed in a randomised controlled trial, compared with an active control group, in which participants are given an information booklet on local social activities. Participants are aged 18 or over, have a primary diagnosis of a psychotic disorder (International Classification of Disease: F20–29) and capacity to provide informed consent. Participants are assessed at baseline and at 6, 12 and 18 months after individual randomisation. The primary outcome is quality of life at 6 months (Manchester Short Assessment of Quality of Life). We hypothesise that the effects on quality of life are mediated by an increase in social contacts. Secondary outcomes are symptoms, social situation and time spent in social activities. Costs and cost-effectiveness analyses will consider service use and health-related quality of life.Ethics and disseminationNational Health Service REC London Hampstead (19/LO/0088) provided a favourable opinion. Findings will be disseminated through a website, social media, scientific papers and user-friendly reports, in collaboration with a lived experience advisory panel.Trial registration numberISRCTN15815862.

scholarly journals Multifactorial falls prevention programme compared with usual care in UK care homes for older people: multicentre cluster randomised controlled trial with economic evaluation

BMJ ◽  
2021 ◽  
pp. e066991 ◽  
Author(s):  
Pip A Logan ◽  
Jane C Horne ◽  
John R F Gladman ◽  
Adam L Gordon ◽  
Tracey Sach ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Care Homes ◽  
Prevention Programme ◽  
Term Care ◽  
Randomised Controlled

Abstract Objectives To determine the clinical and cost effectiveness of a multifactorial fall prevention programme compared with usual care in long term care homes. Design Multicentre, parallel, cluster randomised controlled trial. Setting Long term care homes in the UK, registered to care for older people or those with dementia. Participants 1657 consenting residents and 84 care homes. 39 were randomised to the intervention group and 45 were randomised to usual care. Interventions Guide to Action for Care Homes (GtACH): a multifactorial fall prevention programme or usual care. Main outcome measures Primary outcome measure was fall rate at 91-180 days after randomisation. The economic evaluation measured health related quality of life using quality adjusted life years (QALYs) derived from the five domain five level version of the EuroQoL index (EQ-5D-5L) or proxy version (EQ-5D-5L-P) and the Dementia Quality of Life utility measure (DEMQOL-U), which were self-completed by competent residents and by a care home staff member proxy (DEMQOL-P-U) for all residents (in case the ability to complete changed during the study) until 12 months after randomisation. Secondary outcome measures were falls at 1-90, 181-270, and 271-360 days after randomisation, Barthel index score, and the Physical Activity Measure-Residential Care Homes (PAM-RC) score at 91, 180, 270, and 360 days after randomisation. Results Mean age of residents was 85 years. 32% were men. GtACH training was delivered to 1051/1480 staff (71%). Primary outcome data were available for 630 participants in the GtACH group and 712 in the usual care group. The unadjusted incidence rate ratio for falls between 91 and 180 days was 0.57 (95% confidence interval 0.45 to 0.71, P<0.001) in favour of the GtACH programme (GtACH: six falls/1000 residents v usual care: 10 falls/1000). Barthel activities of daily living indices and PAM-RC scores were similar between groups at all time points. The incremental cost was £108 (95% confidence interval −£271.06 to 487.58), incremental QALYs gained for EQ-5D-5L-P was 0.024 (95% confidence interval 0.004 to 0.044) and for DEMQOL-P-U was 0.005 (−0.019 to 0.03). The incremental costs per EQ-5D-5L-P and DEMQOL-P-U based QALY were £4544 and £20 889, respectively. Conclusions The GtACH programme was associated with a reduction in fall rate and cost effectiveness, without a decrease in activity or increase in dependency. Trial registration ISRCTN34353836 .

scholarly journals Effectiveness of chest physiotherapy and pulmonary rehabilitation in patients with non-cystic fibrosis bronchiectasis: a narrative review

2020 ◽  
Vol 90 (1) ◽  
Author(s):  
Sara Annoni ◽  
Angela Bellofiore ◽  
Elena Repossini ◽  
Marta Lazzeri ◽  
Antonello Nicolini ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cystic Fibrosis ◽  
Pulmonary Rehabilitation ◽  
Hypertonic Solution ◽  
Exacerbation Rate ◽  
Airway Clearance ◽  
Fatigue Exercise ◽  
Sputum Volume

Respiratory physiotherapy and rehabilitation are important therapeutic options in non-cystic fibrosis bronchiectasis (NCFB). The aims of this review of clinical trials were to evaluate the safety and the effects on physiologic and clinical outcomes of airway clearance techniques (ACTs) and rehabilitation in NCFB patients, in comparison to usual care. The search was performed on March 2018 by using PubMed and PeDro databases. 33 studies were selected. The use of ACTs for NCFB were effective in increasing sputum volume although no benefit in quality of life (QoL) or pulmonary exacerbations were observed. There were no differences in effectiveness between the several techniques used. Humidification and saline inhalation were able to aid airway clearance. Hypertonic solution (HS) was more effective than isotonic solutions (IS) in improving expectoration and sputum viscosity. Pulmonary rehabilitation (PR) was found to be associated with short term benefits in exercise capacity, dyspnea and fatigue. Exercise training seems to improve quality of life and lower exacerbation rate, but long-term data are not available. Further studies are necessary to identify the most feasible long-term outcomes such as QoL and exacerbation rate.

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