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.

Comparison of two dose escalation strategies of methotrexate in active rheumatoid arthritis: a multicentre, parallel group, randomised controlled trial

2021 ◽  
pp. annrheumdis-2021-220512
Author(s):  
Siddharth Jain ◽  
Varun Dhir ◽  
Amita Aggarwal ◽  
Ranjan Gupta ◽  
Bidyalaxmi Leishangthem ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Controlled Trial ◽  
Group Differences ◽  
Drug Discontinuation ◽  
Open Label ◽  
Intention To Treat ◽  
Parallel Group ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesThere are no head-to-head trials of different dose escalation strategies of methotrexate (MTX) in RA. We compared the efficacy, safety and tolerability of ‘usual’ (5 mg every 4 weeks) versus ‘fast’ (5 mg every 2 weeks) escalation of oral MTX.MethodsThis multicentre, open-label (assessor blinded) RCT included patients 18-55 years of age having active RA with disease duration <5 years, and not on DMARDs. Patients were randomized 1:1 into usual or fast escalation groups, both groups starting MTX at 15 mg/week till a maximum of 25 mg/week. Primary outcome was EULAR good response at 16 weeks, secondary outcomes were ΔDAS28 and adverse effects (AE). Analyses were intention-to-treat.Results178 patients with mean DAS28-CRP of 5.4(1.1) were randomized to usual (n=89) or fast escalation groups (n=89). At 16 weeks, there was no difference in good EULAR response in the usual (28.1%) or fast escalation (22.5%) groups (p=0.8). There was no difference in mean ΔDAS28-CRP at 8 weeks (-0.9, -0.8, p=0.72) or 16 weeks (-1.3, -1.3, p=0.98). Even at 24 weeks (extended follow-up), responses were similar. There were no inter-group differences in ΔHAQ, or MTX-polyglutamates 1-3 levels at 8 or 16 weeks. Gastrointestinal AE were higher in the fast escalation group over initial 8 weeks (27%, 40%, p=0.048), but not over 16 weeks. There was no difference in cytopenias, transaminitis, or drug discontinuation/dose reduction between the groups. No serious AE were seen.ConclusionA faster MTX escalation strategy in RA was not more efficacious over 16-24 weeks, and did not significantly increase AE, except higher gastrointestinal AE initially.Trial registration numberCTRI/2018/12/016549

scholarly journals TELEmedicine for EPIlepsy Care (TELE-EPIC): protocol of a randomised, open controlled non-inferiority clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053980
Author(s):  
Laura Licchetta ◽  
Marina Trivisano ◽  
Elisa Baldin ◽  
Susan Mohamed ◽  
Emanuel Raschi ◽  
...  
Keyword(s):  
Seizure Control ◽  
Controlled Trial ◽  
Complete Information ◽  
Video Consultation ◽  
Registration Number ◽  
Health Institutions ◽  
Potential Impact ◽  
Randomised Controlled

IntroductionEpilepsy is a chronic condition requiring consistent follow-up aimed at seizure control, and monitoring of anti-seizure medication (ASM) levels and side effects. Telemedicine (TM) offers invaluable support to patient follow-up, guaranteeing the prompt availability of a team of experts for persons with epilepsy (PWE) widely distributed across the country. Although many health institutions have endorsed the use of TM, robust data on effectiveness, safety and costs of TM applied to epilepsy are lacking. TELEmedicine for EPIlepsy Care (TELE-EPIC) will evaluate the effectiveness of video consultation (VC) via TM compared with usual care (UC) for the monitoring of PWE (TELE-EPIC_RCT). Moreover, TELE-EPIC will apply an innovative Volumetric Absorptive Microsampling (VAMS) device for quantitation of ASM through finger prick blood sampling as an alternative to venipuncture sampling (TELE-EPIC_VAMS).Methods and analysisTELE-EPIC_RCT is a multicentre, open, pragmatic two-arm randomised controlled trial prospectively including adult and paediatric outpatients with established diagnosis of epilepsy consecutively attending the Epilepsy Centres of Bologna and Rome, respectively. The primary outcome is the non-inferiority of VC on seizure control compared with UC after an 18-month follow-up. Secondary outcomes are adherence to treatment, ASM-related adverse events, quality of life, mood disorders, patient and caregiver satisfaction, safety and costs. TELE-EPIC_VAMS is a cross-validation study for blood ASM quantitation through a novel, VAMS-based device, comparing (1) VAMS versus plasma samples (reference standard method); and (2) nurse-collected versus self-collected blood by VAMS device.Ethics and disseminationThe study has been approved by the local ethics committee (349-2019-SPER-AUSLBO). Complete information about the state of project, relevant events and results will be regularly updated on the project’s webpage on ClinicalTrials.gov. The project’s results and data on the potential impact of TM in epilepsy will be disseminated on social media. A closeout meeting will be convened for the communication and dissemination of the project, highlighting its main achievements and impacts.Trial registration numberNCT04496310

scholarly journals Estimating the minimum important difference in the DEMQOL instrument in people with dementia

2021 ◽  
Author(s):  
Ellen C. Lee ◽  
Jessica Wright ◽  
Stephen J. Walters ◽  
Cindy L. Cooper ◽  
Gail A. Mountain
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Minimum Important Difference ◽  
Absolute Change ◽  
People With Dementia ◽  
Related Quality ◽  
Registration Number ◽  
Clinically Significant ◽  
Randomised Controlled

Abstract Purpose The Dementia-Related Quality of Life (DEMQOL) measure and the DEMQOL-Utility Score (DEMQOL-U) are validated tools for measuring quality of life (QOL) in people with dementia. What score changes translate to a clinically significant impact on patients’ lives was unknown. This study establishes the minimal important differences (MID) for these two instruments. Methods Anchor-based and distribution-based methods were used to estimate the MID scores from patients enrolled in a randomised controlled trial. For the anchor-based method, the global QOL (Q29) item from the DEMQOL was chosen as the anchor for DEMQOL and both Q29 and EQ-5D for DEMQOL-U. A one category difference in Q29, and a 0.07 point difference in EQ-5D score, were used to classify improvement and deterioration, and the MID scores were calculated for each category. These results were compared with scores obtained by the distribution-based methods. Results A total of 490 people with dementia had baseline DEMQOL data, of these 386 had 8-month data, and 344 had 12-month DEMQOL data. The absolute change in DEMQOL for a combined 1-point increase or decrease in the Q29 anchor was 5.2 at 8 months and 6.0 at 12 months. For the DEMQOL-U, the average absolute change at 8 and 12 months was 0.032 and 0.046 for the Q29 anchor and 0.020 and 0.024 for EQ-5D anchor. Conclusion We present MID scores for the DEMQOL and DEMQOL-U instruments obtained from a large cohort of patients with dementia. An anchored-based estimate of the MID for the DEMQOL is around 5 to 6 points; and 0.02 to 0.05 points for the DEMQOL-U. The results of this study can guide clinicians and researchers in the interpretation of these instruments comparisons between groups or within groups of people with dementia. Trial Registration Number and date of registration: ISRCTN17993825 on 11th October 2016.

scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

scholarly journals Relative effectiveness of a full versus reduced version of the ‘Smoke Free’ mobile application for smoking cessation: a randomised controlled trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 1524 ◽  
Author(s):  
David Crane ◽  
Harveen Kaur Ubhi ◽  
Jamie Brown ◽  
Robert West
Keyword(s):  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Relative Effectiveness ◽  
Behaviour Change Techniques ◽  
Full Version ◽  
Intention To Treat ◽  
Support Programmes ◽  
Randomised Controlled

Background: Smartphone applications (apps) are popular aids for smoking cessation. Smoke Free is an app that delivers behaviour change techniques used in effective face-to-face behavioural support programmes. The aim of this study was to assess whether the full version of Smoke Free is more effective than the reduced version. Methods:  This was a two-arm randomised controlled trial. Smokers who downloaded Smoke Free were randomly offered the full or reduced version; 28,112 smokers aged 18+ years who set a quit date were included. The full version provided updates on benefits of abstinence, progress (days smoke free), virtual ‘badges’ and daily ‘missions’ with push notifications aimed at preventing and managing cravings. The reduced version did not include the missions. At baseline the app recorded users’: device type (iPhone or Android), age, sex, daily cigarette consumption, time to first cigarette of the day, and educational level. The primary outcome was self-reported complete abstinence from the quit date in a 3-month follow-up questionnaire delivered via the app. Analyses conducted included logistic regressions of outcome on to app version (full versus reduced) with adjustment for baseline variables using both intention-to-treat/missing-equals smoking (MES) and follow-up-only (FUO) analyses. Results: The 3-month follow-up rate was 8.5% (n=1,213) for the intervention and 6.5% (n=901) for the control. A total of 234 participants reported not smoking in the intervention versus 124 in the control, representing 1.6% versus 0.9% in the MES analysis and 19.3% versus 13.8% in the FUO analysis. Adjusted odds ratios were 1.90, 95%CI=1.53-2.37 (p<0.001) and 1.50, 95%CI=1.18-1.91 (p<0.001) in the MES and FUO analyses respectively. Conclusions: Despite very low follow-up rates using in-app follow up, both intention-to-treat/missing equals smoking and follow-up only analyses showed the full version of the Smoke Free app to result in higher self-reported 3-month continuous smoking abstinence rates than the reduced version.

scholarly journals P001 IS PROPHYLACTIC MESH IS ROUTINELY REQUIRED FOR STOMA CONSTRUCTION? IDENTIFICATION OF THE ‘TARGET GROUP’

2021 ◽  
Vol 108 (Supplement_8) ◽  
Author(s):  
Ahmed Hassan ◽  
Wei Toh ◽  
James Ayathamattam ◽  
Zachary Thomas ◽  
Ondrej Ryska
Keyword(s):  
Controlled Trial ◽  
Cost Benefit ◽  
Prophylactic Mesh ◽  
Nice Guidelines ◽  
Prophylactic Measures ◽  
Increased Risk ◽  
End Colostomy ◽  
Randomised Controlled

Abstract Background Evidence to support routine prophylactic mesh insertion during stoma construction is conflicting. The PREVENT randomised controlled trial (RCT) suggested lower incidence of parastomal hernia (PSH) with prophylactic mesh but with no quality of life or cost benefit. Another two RCTs has shown no prophylactic benefit (STOMAMESH & STOMA-const). Although European Hernia guidelines recommends routine prophylactic mesh in end-colostomy, NICE guidelines suggest mesh on individual basis not routinely. Aim To identify the group with higher risk to develop a symptomatic PSH when prophylactic mesh should be considered Material and Methods A single center retrospective review of all stoma formed. Younger patient than 18 years and patients who had less than 6 months’ follow-up were excluded. Development of PSH was confirmed by radiological evidence or direct intra-operative visualization Results 194 patients between January 2015 till December 2019 were included with mean follow-up of 15.7±13.5 months where 91 patients developed PSH. On multivariate analysis, older age (&gt;65) (OR 2.3, 95% CI 1.08 – 4.99, p 0.03) and Obesity (OR 5.8, 95% CI 2.53 – 13.57, p 0.00) were risk factors of developing PSH. Among the PSH group, 28 were symptomatic (31%). Symptomatic subgroup had higher ASA (ASA &gt;2) than asymptomatic subgroup (50% Vs 27%, p 0.05) Conclusions Obese patients older than 65 years are at increased risk of PSH. IF their ASA &gt;2 this PSH is likely to become symptomatic. This is the group who should benefit the most from prophylactic measures including mesh insertion and should be targeted for future trials

scholarly journals Involving clinical experts in prioritising topics for health technology assessment: a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e016104 ◽  
Author(s):  
Andrew Cook ◽  
Elke Streit ◽  
Gill Davage
Keyword(s):  
Controlled Trial ◽  
Free Text ◽  
Intention To Treat ◽  
Cohen’S D ◽  
Registration Number ◽  
Review Form ◽  
Response Modes ◽  
Randomised Controlled ◽  
Scoring Tool ◽  
Cohen's D

ObjectivesThe objective of this study was to explore whether reducing the material supplied to external experts during peer review and decreasing the burden of response would maintain review quality into prioritising research questions for a major research funder.Methods and analysisClinical experts who agreed to review documents outlining research for potential commissioning were screened for eligibility and randomised in a factorial design to two types of review materials (long document versus short document) and response modes (structured review form versus free text email response). Previous and current members of the funder’s programme groups were excluded. Response quality was assessed by use of a four-point scoring tool and analysed by intention to treat.Results554 consecutive experts were screened for eligibility and 460 were randomised (232 and 228 to long document or short document, respectively; 230 each to structured response or free text). 356 participants provided reviews, 90 did not respond and 14 were excluded after randomisation as not eligible.The pooled mean quality score was 2.4 (SD=0.95). The short document scored 0.037 (Cohen’s d=0.039) extra quality points over the long document arm, and the structured response scored 0.335 (Cohen’s d=0.353) over free text. The allocation did not appear to have any effect on the experts' willingness to engage with the task.ConclusionsNeither providing a short or a long document outlining suggested research was shown to be superior. However, providing a structured form to guide the expert response provided more useful information than allowing free text. The funder should continue to use a structured form to gather responses. It would be acceptable to provide shorter documents to reviewers, if there were reasons to do so.Trial registration numberANZCTR12614000167662.

Inspiratory muscle training does not improve clinical outcomes in 3-week COPD rehabilitation: results from a randomised controlled trial

2018 ◽  
Vol 51 (1) ◽  
pp. 1702000 ◽  
Author(s):  
Konrad Schultz ◽  
Danijel Jelusic ◽  
Michael Wittmann ◽  
Benjamin Krämer ◽  
Veronika Huber ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Inspiratory Muscle ◽  
Inspiratory Muscle Training ◽  
Chronic Obstructive ◽  
Muscle Training ◽  
Randomised Controlled

The value of inspiratory muscle training (IMT) in pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD) is unclear. The RIMTCORE (Routine Inspiratory Muscle Training within COPD Rehabilitation) randomised controlled trial examined the effectiveness of IMT added to pulmonary rehabilitation.In total, 611 COPD patients (Global Initiative for Chronic Obstructive Lung Disease stage II–IV) received a 3-week inpatient pulmonary rehabilitation, of which 602 patients were included in the intention-to-treat analyses. The intervention group (n=300) received highly intensive IMT and the control group (n=302) received sham IMT. The primary outcome was maximal inspiratory pressure (PImax). The secondary outcomes were 6-min walk distance, dyspnoea, quality of life and lung function. Outcomes were assessed pre- and post-pulmonary rehabilitation. ANCOVA was used.The intervention group showed higher effects in PImax (p<0.001) and forced inspiratory volume in 1 s (p=0.013). All other outcomes in both study groups improved significantly, but without further between-group differences. Sex and pulmonary rehabilitation admission shortly after hospitalisation modified quality of life effects.IMT as an add-on to a 3-week pulmonary rehabilitation improves inspiratory muscle strength, but does not provide additional benefits in terms of exercise capacity, quality of life or dyspnoea. A general recommendation for COPD patients to add IMT to a 3-week pulmonary rehabilitation cannot be made.

Using feeding to reduce pain during vaccination of formula-fed infants: a randomised controlled trial

2018 ◽  
Vol 103 (12) ◽  
pp. 1132-1137 ◽  
Author(s):  
Netty G P Bos-Veneman ◽  
Marrit Otter ◽  
Sijmen A Reijneveld
Keyword(s):  
Side Effects ◽  
Controlled Trial ◽  
Recovery Phase ◽  
Pain Scale ◽  
Formula Feeding ◽  
Full Term ◽  
Intention To Treat ◽  
Registration Number ◽  
The Face ◽  
Randomised Controlled

ObjectivesTo assess the effectiveness and potential side effects of formula feeding to reduce pain during vaccination among infants.Study designIn the setting of well-baby clinics we recruited a community-based sample of full-term born infants who were already formula fed by the choice of the parents (n=48, aged 4–10 weeks) and received their first DTaP-IPV-HepB-Hib and pneumococcal vaccinations and randomised them into two groups. To evaluate pain experienced during vaccination we compared infants who drank formula feeding before, during and after vaccination with infants who did not. Outcomes were observed cry duration and pain scores measured by means of the Neonatal Infant Pain Scale (NIPS) and the Face, Legs, Activity, Cry and Consolability (FLACC) scale. Side effects of drinking during vaccination were recorded. We performed intention-to-treat analyses using regression models, crude and adjusted for sex and age of the infant.ResultsPain at the moment of the second injection did not differ between groups. Drinking infants cried 33.5 s shorter (−56.6; −10.3). In the first minute after injection drinking infants experienced a faster pain reduction on the NIPSΔt: regression coefficient 3.86 (95% CI 2.70 to 5.02) and FLACCΔt: 4.42 (95% CI 2.85 to 5.99).ConclusionsIn line with findings of previous studies regarding breast feeding, formula feeding reduced vaccination pain in the recovery phase in full-term born infants receiving their first vaccinations between ages 4 and 10 weeks with no adverse effects. Professionals should discuss this non-costly and feasible pain-reducing intervention with parents of infants who receive vaccinations.Trial registration numberIRCTN 31383, post-results

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