scholarly journals Study protocol for a randomised controlled trial assessing the impact of pulmonary rehabilitation on maximal exercise capacity for adults living with post-TB lung disease: Global RECHARGE Uganda

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e047641
Author(s):  
Winceslaus Katagira ◽  
Mark W. Orme ◽  
Amy V. Jones ◽  
Richard Kasiita ◽  
Rupert Jones ◽  
...  
Keyword(s):  
Lung Disease ◽  
Usual Care ◽  
Pulmonary Rehabilitation ◽  
Maximal Exercise ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Intention To Treat ◽  
Secondary Outcomes ◽  
The Impact ◽  
Maximal Exercise Capacity

IntroductionThe burden of post-tuberculosis (TB) lung disease (PTBLD) is steadily increasing in sub-Saharan Africa, causing disability among TB survivors. Without effective medicines, the mainstay of PTBLD treatment evolves around disease prevention and supportive treatment. Pulmonary rehabilitation (PR), a low-cost, non-pharmacological intervention has shown effectiveness in a group of PTBLD individuals but has not been tested in a clinical trial. This study aims to assess the impact of a 6-week PR programme on maximal exercise capacity and other outcomes among adults in Uganda living with PTBLD.Methods and analysisThis is a randomised waiting-list controlled trial with blinded outcome measures, comparing PR versus usual care for patients with PTBLD. A total of 114 participants will be randomised (1:1) to receive either usual care (on the waiting list) or PR, with follow-up assessments at 6 weeks and 12 weeks postintervention. The primary outcome is change in walking distance measured by the Incremental Shuttle Walk Test from baseline to the end of 6 weeks of PR. All secondary outcomes will be compared between the PR and usual care arms from baseline to 6-week and 12-week follow-ups. Secondary outcomes include self-reported respiratory symptoms, physical activity, psychological well-being, health-related quality of life and cost–benefit analysis. All randomised participants will be included in the intention-to-treat analysis population. The primary efficacy analysis will be based on both per-protocol and modified intention-to-treat populations.Ethics and disseminationThe trial has received ethical clearance from the Mulago Hospital Research and Ethics Committee (MHREC 1478), Kampala, Uganda as well as the Uganda National Council for Science and Technology (SS 5105). Ethical approval has been obtained from the University of Leicester, UK research ethics committee (Ref No. 22349). Study findings will be published in appropriate peer-reviewed journals and disseminated at appropriate local, regional and international scientific meetings and conferences.Trial registration numberISRCTN18256843.Protocol versionVersion 1.0 July 2019.

Survival after inpatient or outpatient pulmonary rehabilitation in patients with fibrotic interstitial lung disease: a multicentre retrospective cohort study

Thorax ◽  
2021 ◽  
pp. thoraxjnl-2021-217361
Author(s):  
Sabina Anna Guler ◽  
Seo Am Hur ◽  
Michael K Stickland ◽  
Patrick Brun ◽  
Luc Bovet ◽  
...  
Keyword(s):  
Cohort Study ◽  
Interstitial Lung Disease ◽  
Randomised Controlled Trial ◽  
Lung Disease ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Time To Death ◽  
Risk Of Death ◽  
Randomised Controlled ◽  
The Impact

BackgroundThe impact of pulmonary rehabilitation (PR) on survival in patients with fibrotic interstitial lung disease (ILD) is unknown. Given the challenges conducting a large randomised controlled trial, we aimed to determine whether improvement in 6-minute walk distance (6MWD) was associated with better survival.MethodsThis retrospective, international cohort study included patients with fibrotic ILD participating in either inpatient or outpatient PR at 12 sites in 5 countries. Multivariable models were used to estimate the association between change in 6MWD and time to death or lung transplantation accounting for clustering by centre and other confounders.Results701 participants (445 men and 256 women) with fibrotic ILD were included. The mean±SD ages of the 196 inpatients and 505 outpatients were 70±11 and 69±12 years, respectively. Baseline/changes in 6MWD were 262±128/55±83 m for inpatients and 358±125/34±65 m for outpatients. Improvement in 6MWD during PR was associated with lower hazard rates for death or lung transplant on adjusted analysis for both inpatient (HR per 10 m 0.94, 95% CI 0.91 to 0.97, p<0.001) and outpatient PR (HR 0.97, 95% CI 0.95 to 1.00, p=0.042). Participation in ≥80% of planned outpatient PR sessions was associated with a 33% lower risk of death (95% CI 0.49% to 0.92%).ConclusionsPatients with fibrotic ILD who improved physical performance during PR had better survival compared with those who did not improve performance. Confirmation of these hypothesis-generating findings in a randomised controlled trial would be required to definitely change clinical practice, and would further support efforts to improve availability of PR for patients with fibrotic ILD.

scholarly journals Rapid Multiplex Testing for Upper Respiratory Pathogens in the Emergency Department: A Randomized Controlled Trial

2019 ◽  
Author(s):  
Larissa May ◽  
Grant Tatro ◽  
Eduard Poltavskiy ◽  
Benjamin Mooso ◽  
Simson Hon ◽  
...  
Keyword(s):  
Emergency Department ◽  
Length Of Stay ◽  
Usual Care ◽  
Controlled Trial ◽  
Antibiotic Use ◽  
Respiratory Pathogens ◽  
Upper Respiratory Tract ◽  
Upper Respiratory ◽  
Tract Infections ◽  
The Impact

Abstract Background Acute upper respiratory tract infections are a common cause of Emergency Department (ED) visits and often result in unnecessary antibiotic treatment.  Methods We conducted a randomized clinical trial to evaluate the impact of a rapid, multi-pathogen respiratory panel (RP) test versus usual care (control). Patients were eligible if they were ≥12 months old, had symptoms of upper respiratory infection or influenza like illness, and were not on antibiotics. The primary outcome was antibiotic prescription; secondary outcomes included antiviral prescription, disposition, and length of stay (ClinicalTrials.gov# NCT02957136). Results Of 191 patients enrolled, 93 (49%) received RP testing; 98 (51%) received usual care. Fifty-three (57%) RP and 7 (7%) control patients had a virus detected and reported during the ED visit (p=0.0001). Twenty (22%) RP patients and 33 (34%) usual care patients received antibiotics during the ED visit (-12% [95% CI -25%, 0.4%]; p=0.06/0.08); 9 RP patients received antibiotics despite having a virus detected. The magnitude of antibiotic reduction was greater in children (-19%) versus adults (-9%; post-hoc analysis). There was no difference in antiviral use, length of stay, or disposition. Conclusions Rapid RP testing was associated with a trend towards decreased antibiotic use, suggesting a potential benefit from more rapid viral tests in the ED. Future studies should determine if specific groups are more likely to benefit from testing and evaluate relative cost and effectiveness of broad testing, focused testing, and a combined diagnostic and antimicrobial stewardship approach.

scholarly journals Outcomes and safety of concomitant topiramate or metformin for antipsychotics-induced obesity: a randomized-controlled trial

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Congjie Wang ◽  
Wenjie Shi ◽  
Jianyang Xu ◽  
Chengbing Huang ◽  
Jiannan Zhu
Keyword(s):  
Missing Values ◽  
Psychiatric Patients ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Waist Hip Ratio ◽  
Reduced Body ◽  
Metformin Group ◽  
Significant Difference ◽  
The Impact ◽  
Baseline Bmi

Abstract Background Although there are some existing data describing the usage of topiramate in patients with antipsychotic-induced obesity, study on its comparison with metformin is limited. This study aimed to explore the effectiveness and safety of concomitant topiramate on antipsychotic-induced obesity as well as its comparison with metformin. Methods 62 stabilized outpatients with antipsychotic-induced obesity were randomized into the topiramate group and the metformin group with 16-week treatment. The patients’ weight, body mass index (BMI), waist–hip ratio, and their side effects were assessed and compared. Intention-to-treat and completer analyses were performed. Meanwhile, covariance analysis was conducted to control the impact of the significant difference in BMI between the two groups. Results The two groups had comparable characteristics, though their difference in baseline BMI was significant. (1) Intention-to-treat analyses: the random missing values were replaced using the last observation carried forward method when intention-to-treat analyses were conducted. Compared with the baseline, the weight, BMI, and waist–hip ratio in the topiramate group markedly decreased at each follow-up, whereas, in the metformin group, only waist–hip ratio significantly decreased at 4 weeks after treatment. Compared with the metformin, only weight and BMI in the topiramate group were significantly decreased at week 4 after treatment, and at week 8–16, weight, BMI and waist–hip ratio were remarkably declined. (2) Completer analyses: compared with the baseline, the weight, BMI, and waist–hip ratio in the topiramate group at week 4–16 were markedly decreased, whereas only waist–hip ratio with metformin was significantly decreased at week 4. Compared with the metformin, all BMI with topiramate were markedly decreased at week 4–16. Moreover, its weight and waist–hip ratio also were notably lowered at week 8. No significant differences in adverse events were found between the two groups. Conclusions Topiramate, similar to metformin in reducing obesity as previously reported, also significantly reduced body weight, BMI, and waist–hip ratio in patients with antipsychotic-induced obesity and demonstrated well tolerance in psychiatric patients. Trialregistration The trial was registered at http://www.chictr.org.cn, and the number was ChiCTR-IPR-17013122.

Effectiveness of an innovative and comprehensive eye care model for individuals in residential care facilities: results of the residential ocular care (ROC) multicentred randomised controlled trial

2020 ◽  
pp. bjophthalmol-2019-315620
Author(s):  
Ryan Eyn Kidd Man ◽  
Alfred Tau Liang Gan ◽  
Marios Constantinou ◽  
Eva K Fenwick ◽  
Edith Holloway ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Residential Care ◽  
Controlled Trial ◽  
Well Being ◽  
Vision Impairment ◽  
Residential Care Facilities ◽  
Care Facilities ◽  
Randomised Controlled ◽  
The Impact

BackgroundTo assess the clinical and patient-centred effectiveness of a novel residential ocular care (ROC) model in Australian individuals residing in residential care.MethodsIn this prospective, multicentred, randomised controlled trial conducted in 38 Australian aged-care facilities (2015–2017), 178 visually impaired individuals living in residential care facilities (mean age ±SD: 83.9±8.6 years; 65.7% women) were cluster randomised to ROC (n=95) or usual care (n=83) pathways. The ROC arm comprised a tailored and comprehensive within-site eye examination and care rehabilitation pathway, while usual care participants were given a referral to an external eyecare provider. Outcomes included presenting distance and near visual acuity (PNVA); Rasch-transformed Reading, Emotional and Mobility scores from the Impact of Vision Impairment questionnaire; quality of vision (QoV comprising Rasch-transformed Frequency, Severity and Bother domains) scores; Euroqol-5-Dimensions (raw scores); Cornell Scale for Depression (raw scores) and 6-month falls frequency, assessed at baseline and 6 months post intervention. Within-group and between-group comparisons were conducted using linear mixed models, adjusted for baseline differences in characteristics between the two arms.ResultsAt 6 months, intention-to-treat analyses showed significant between-group improvements in ROC residents compared with usual care for PNVA, Emotional and QoV scores (all p<0.05) These significant findings were retained in per-protocol analyses. No other between-group changes were observed.ConclusionOur ROC model was effective in improving near vision, emotional well-being and perceived burden of vision-related symptoms in residential care dwellers in Australia with vision impairment. Future studies to evaluate the cost effectiveness and implementation of ROC in Australia are warranted.

scholarly journals Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e036327 ◽  
Author(s):  
Belay Bayissasse ◽  
Kristin M Sullivan ◽  
Shannath L Merbs ◽  
Beatriz Munoz ◽  
Alexander Keil ◽  
...  
Keyword(s):  
Surgical Outcomes ◽  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Upper Eyelid ◽  
Intention To Treat ◽  
Research Ethics Review ◽  
Registration Number ◽  
Randomised Controlled ◽  
The Impact ◽  
Trachomatous Trichiasis

IntroductionTrachomatous trichiasis (TT) is a condition in which the eyelid turns inward and eyelashes abrade the front part of the eye. To prevent eventual blindness, surgery is recommended. Two surgical procedures are commonly used, bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR). Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes. However, these studies have not prospectively compared the impact of incision height on surgical outcomes.Methods and analysisMaximising trichiasis surgery Success (MTSS) is a three-arm, randomised clinical trial being conducted in Ethiopia. Participants will be randomly assigned on a 1:1:1 basis to BLTR with a 3 mm incision height, BLTR with a 5 mm incision height, or PLTR 3 mm incision height. Patients are eligible for the trial if they have previously unoperated upper eyelid TT. Follow-up visits will be conducted by trained eye examiners at 1 day, 2 weeks, 6 weeks and 12 months after surgery. The primary outcome is incident PTT within 1 year following surgery. Logistic regression will be used in an intention-to-treat analysis to assess outcome incidence by surgical approach.Ethics and disseminationThe University of North Carolina and Johns Hopkins School of Medicine institution review boards, Ethiopian National Research Ethics Review Committee and Ethiopian Food, Medicine, Healthcare and Administration and Control Authority provided ethics approval for the trial. On completion, trial results will be disseminated at local and international meetings and in peer-reviewed journals.Trial registration numberNCT03100747.

scholarly journals Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial

Thorax ◽  
2020 ◽  
Vol 75 (5) ◽  
pp. 413-421 ◽  
Author(s):  
Henrik Hansen ◽  
Theresa Bieler ◽  
Nina Beyer ◽  
Thomas Kallemose ◽  
Jon Torgny Wilcke ◽  
...  
Keyword(s):  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Drop Out ◽  
Group Differences ◽  
Primary Analysis ◽  
Intention To Treat ◽  
Registration Number ◽  
Randomised Controlled

RationalePulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR).ObjectiveTo investigate whether PTR is superior to conventional PR on 6 min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life, physical activity and lower limb muscle function in patients with COPD and FEV1 <50% eligible for routine hospital-based, outpatient PR.MethodsIn this single-blinded, multicentre, superiority randomised controlled trial, patients were assigned 1:1 to 10 weeks of groups-based PTR (60 min, three times weekly) or conventional PR (90 min, two times weekly). Assessments were performed by blinded assessors at baseline, end of intervention and at 22 weeks’ follow-up from baseline. The primary analysis was based on the intention-to-treat principle.Measurements and main resultsThe primary outcome was change in 6MWD from baseline to 10 weeks; 134 participants (74 females, mean±SD age 68±9 years, FEV1 33%±9% predicted, 6MWD 327±103 metres) were included and randomised. The analysis showed no between-group differences for changes in 6MWD after intervention (9.2 metres (95% CI: −6.6 to 24.9)) or at 22 weeks’ follow-up (−5.3 metres (95% CI: −28.9 to 18.3)). More participants completed the PTR intervention (n=57) than conventional PR (n=43) (χ2 test p<0.01).ConclusionPTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design.Trial registration numberClinicalTrials.gov (NCT02667171), 28 January 2016.

scholarly journals Metacognitive reflection and insight therapy (MERIT) for patients with schizophrenia

2018 ◽  
Vol 49 (2) ◽  
pp. 303-313 ◽  
Author(s):  
S. de Jong ◽  
R. J. M. van Donkersgoed ◽  
M. E. Timmerman ◽  
M. aan het Rot ◽  
L. Wunderink ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Drop Out ◽  
Future Research ◽  
Control Group ◽  
Treatment As Usual ◽  
Self Reflection ◽  
Intention To Treat ◽  
Metacognitive Reflection ◽  
Secondary Outcomes

AbstractBackgroundImpaired metacognition is associated with difficulties in the daily functioning of people with psychosis. Metacognition can be divided into four domains: Self-Reflection, Understanding the Other's Mind, Decentration, and Mastery. This study investigated whether Metacognitive Reflection and Insight Therapy (MERIT) can be used to improve metacognition.MethodsThis study is a randomized controlled trial. Patients in the active condition (n = 35) received forty MERIT sessions, the control group (n = 35) received treatment as usual. Multilevel intention-to-treat and completers analyses were performed for metacognition and secondary outcomes (psychotic symptomatology, cognitive insight, Theory of Mind, empathy, depression, self-stigma, quality of life, social functioning, and work readiness).ResultsEighteen out of 35 participants finished treatment, half the drop-out stemmed from therapist attrition (N = 5) or before the first session (N = 4). Intention-to-treat analysis demonstrated that in both groups metacognition improved between pre- and post-measurements, with no significant differences between the groups. Patients who received MERIT continued to improve, while the control group returned to baseline, leading to significant differences at follow-up. Completers analysis (18/35) showed improvements on the Metacognition Assessment Scale (MAS-A) scales Self Reflectivity and metacognitive Mastery at follow-up. No effects were found on secondary outcomes.ConclusionsOn average, participants in the MERIT group were, based on MAS-A scores, at follow-up more likely to recognize their thoughts as changeable rather than as facts. MERIT might be useful for patients whose self-reflection is too limited to benefit from other therapies. Given how no changes were found in secondary measures, further research is needed. Limitations and suggestions for future research are discussed.

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