scholarly journals The London Exercise And Pregnant smokers (LEAP) trial: a randomised controlled trial of physical activity for smoking cessation in pregnancy with an economic evaluation

2015 ◽  
Vol 19 (84) ◽  
pp. 1-136 ◽  
Author(s):  
Michael Ussher ◽  
Sarah Lewis ◽  
Paul Aveyard ◽  
Isaac Manyonda ◽  
Robert West ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Economic Evaluation ◽  
Birth Outcomes ◽  
Controlled Trial ◽  
Control Group ◽  
Maternal Weight ◽  
Smoking During Pregnancy ◽  
Behavioural Support ◽  
Significant Difference ◽  
Randomised Controlled

BackgroundSmoking during pregnancy is the main preventable cause of poor birth outcomes. Improved methods are needed to help women to stop smoking during pregnancy. Pregnancy provides a compelling rationale for physical activity (PA) interventions as cessation medication is contraindicated or ineffective, and an effective PA intervention could be highly cost-effective.ObjectiveTo examine the effectiveness and cost-effectiveness of a PA intervention plus standard behavioural support for smoking cessation relative to behavioural support alone for achieving smoking cessation at the end of pregnancy.DesignMulticentre, two-group, pragmatic randomised controlled trial and economic evaluation with follow-up at the end of pregnancy and 6 months postnatally. Randomisation was stratified by centre and a computer-generated sequence was used to allocate participants using a 1 : 1 ratio.Setting13 hospitals offering antenatal care in the UK.ParticipantsWomen between 10 and 24 weeks’ gestation smoking five or more cigarettes a day before pregnancy and one or more during pregnancy.InterventionsParticipants were randomised to behavioural support for smoking cessation (control) or behavioural support plus a PA intervention consisting of supervised treadmill exercise plus PA consultations. Neither participants nor researchers were blinded to treatment allocation.Main outcome measuresThe primary outcome was self-reported, continuous smoking abstinence between a quit date and end of pregnancy, validated by expired carbon monoxide and/or salivary cotinine. Secondary outcomes were maternal weight, depression, birth outcomes, withdrawal symptoms and urges to smoke. The economic evaluation investigated the costs of the PA intervention compared with the control intervention.ResultsIn total, 789 women were randomised (n = 394 PA,n = 395 control). Four were excluded post randomisation (two had been enrolled twice in sequential pregnancies and two were ineligible and randomised erroneously). The intention-to-treat analysis comprised 785 participants (n = 392 PA,n = 393 control). There was no significant difference in the rate of abstinence at the end of pregnancy between the PA group (7.7%) and the control group (6.4%) [odds ratio for PA group abstinence 1.21, 95% confidence interval (CI) 0.70 to 2.10]. For the PA group compared with the control group, there was a 33% (95% CI 14% to 56%), 28% (95% CI 7% to 52%) and 36% (95% CI 12% to 65%) significantly greater increase in self-reported minutes of moderate- and vigorous-intensity PA from baseline to 1 week, 4 weeks and 6 weeks respectively. Accelerometer data showed that there was no significant difference in PA levels between the groups. There were no significant differences between the groups for change in maternal weight, depression, withdrawal symptoms or urges to smoke. Adverse events and birth outcomes were similar between the groups except for there being significantly more caesarean births in the control group than in the PA group (28.7% vs. 21.3%;p < 0.023). The PA intervention was less costly than the control intervention by £35 per participant. This was mainly attributable to increased health-care usage in the control group. However, there was considerable statistical uncertainty around this estimate.ConclusionsDuring pregnancy, offering an intervention combining supervised exercise and PA counselling does not add to the effectiveness of behavioural support for smoking cessation. Only 10% of participants had PA levels accessed by accelerometer and it is, therefore, unclear whether or not the lack of an effect on the primary outcome is the result of insufficient increases in PA. Research is needed to identify the smoking populations most suitable for PA interventions and methods for increasing PA adherence.Trial registrationCurrent Controlled Trials ISRCTN48600346.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 84. See the NIHR Journals Library website for further project information.

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

scholarly journals Effect of Engaging Trainees by Assessing Peer Performance: A Randomised Controlled Trial Using Simulated Patient Scenarios

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Charlotte Loumann Krogh ◽  
Charlotte Ringsted ◽  
Charles B. Kromann ◽  
Maria Birkvad Rasmussen ◽  
Tobias Todsen ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Global Rating ◽  
Training Performance ◽  
Significant Difference ◽  
Training Format ◽  
Peer Performance ◽  
And Performance ◽  
Randomised Controlled

Introduction. The aim of this study was to explore the learning effect of engaging trainees by assessing peer performance during simulation-based training.Methods. Eighty-four final year medical students participated in the study. The intervention involved trainees assessing peer performance during training. Outcome measures were in-training performance and performance, both of which were measured two weeks after the course. Trainees’ performances were videotaped and assessed by two expert raters using a checklist that included a global rating. Trainees’ satisfaction with the training was also evaluated.Results. The intervention group obtained a significantly higher overall in-training performance score than the control group: mean checklist score 20.87 (SD 2.51) versus 19.14 (SD 2.65)P=0.003and mean global rating 3.25 SD (0.99) versus 2.95 (SD 1.09)P=0.014. Postcourse performance did not show any significant difference between the two groups. Trainees who assessed peer performance were more satisfied with the training than those who did not: mean 6.36 (SD 1.00) versus 5.74 (SD 1.33)P=0.025.Conclusion. Engaging trainees in the assessment of peer performance had an immediate effect on in-training performance, but not on the learning outcome measured two weeks later. Trainees had a positive attitude towards the training format.

scholarly journals Out-patient triple chronotherapy for the rapid treatment and maintenance of response in depression: feasibility and pilot randomised controlled trial

BJPsych Open ◽  
2021 ◽  
Vol 7 (6) ◽  
Author(s):  
David Veale ◽  
Marc Serfaty ◽  
Clara Humpston ◽  
Andriani Papageorgiou ◽  
Sarah Markham ◽  
...  
Keyword(s):  
Rating Scale ◽  
Clinical Sample ◽  
Controlled Trial ◽  
Bright Light ◽  
Light Therapy ◽  
Control Group ◽  
Intention To Treat ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Rapid Treatment

Background Triple chronotherapy (sleep deprivation for 36 h, followed by 4 days of advancing the time of sleep and daily morning bright-light therapy for 6 months) has demonstrated benefits for the rapid treatment of depressive symptoms in four small controlled trials of in-patients. Aims To test the feasibility of recruitment and delivery of triple chronotherapy for out-patients with depression (ISRCTN17706836; NCT03405493). Method In a single-blind trial, 82 participants were randomised to triple chronotherapy or a control intervention. The primary outcome was the number of participants recruited per month and adherence to the protocol. Secondary outcomes included the 6-item Hamilton Rating Scale for Depression (HRSD-6) at 1 week. Timings of observer ratings were baseline and 1, 2, 4, 8 and 26 weeks after randomisation. Results The triple chronotherapy group stayed awake for the planned 36 h and 89.9% adhered to the plan of phase advance of their sleep over the following 4 days. We achieved our recruitment target (60 participants completed the trial within 13 months). There were no reported adverse side-effects. We found a significant difference between the groups by intention-to-treat analysis for the HRSD-6 at weeks 1, 8 and 26. There was a large effect size of Cohen's d = 0.8 on HRSD-6 score at week 1, increasing to d = 1.30 at week 26. A response (≥50% reduction in symptoms) was achieved by 33.3% in the triple chronotherapy group and 16.2% in the control group. This stayed relatively steady until week 26 (35.9 v. 13.9%). Conclusions Triple chronotherapy produced a significant and rapid benefit after 1 week in out-patients with depression that was sustained at 26 weeks. Cost-effectiveness trials with a larger clinical sample are required.

scholarly journals Family education for people with schizophrenia in Beijing, China

2005 ◽  
Vol 187 (4) ◽  
pp. 339-345 ◽  
Author(s):  
Zheng Li ◽  
David Arthur
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Family Education ◽  
Control Group ◽  
Large Hospital ◽  
Significant Difference ◽  
Symptom Scores ◽  
Randomised Controlled ◽  
Beijing China ◽  
Experimental Group

BackgroundMuch of China lacks well-developed services for people with schizophrenia and their families, and most of the existing services focus on hospitals. There is a need for culturally sensitive family treatments offered by nurses.AimsTo conduct a longitudinal experimental study examining the effect of patient and family education in a sample of Chinese people with schizophrenia.MethodA randomised controlled trial was conducted in a large hospital with a sample of 101 patients with schizophrenia and their families. Data were collected at admission and at discharge, and then at 3 and 9 months after discharge. The intervention group received family education, and data on their knowledge about schizophrenia, symptoms, functioning, psychosocial behaviour, relapse and medication adherence were collected and compared with the control group.ResultsThere was a significant improvement in knowledge about schizophrenia in the experimental group and a significant difference in symptom scores and functioning at 9 months after discharge. Patients who were non-adherent to medication regimens were more likely to relapse.ConclusionsFamily education on schizophrenia by nurses in China was effective in improving knowledge and promoting improvement in patients' symptoms.

scholarly journals Effects of Peer-Facilitated, Video-Based and Combined Peer-and-Video Education on Anxiety Among Patients Undergoing Coronary Angiography: Randomised controlled trial

2018 ◽  
Vol 18 (1) ◽  
pp. 61 ◽  
Author(s):  
Hosein Habibzadeh ◽  
Zahra D. Milan ◽  
Moloud Radfar ◽  
Audrey Cund
Keyword(s):  
Coronary Angiography ◽  
Controlled Trial ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Patient Anxiety ◽  
Post Intervention ◽  
Persian Language ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Video Education

Objectives: Coronary angiography can be stressful for patients and anxiety-caused physiological responses during the procedure increase the risk of dysrhythmia, coronary artery spasms and rupture. This study therefore aimed to investigate the effects of peer, video and combined peer-and-video training on anxiety among patients undergoing coronary angiography. Methods: This single-blinded randomised controlled clinical trial was conducted at two large educational hospitals in Iran between April and July 2016. A total of 120 adult patients undergoing coronary angiography were recruited. Using a block randomisation method, participants were assigned to one of four groups, with those in the control group receiving no training and those in the three intervention groups receiving either peer-facilitated training, video-based training or a combination of both. A Persian-language validated version of the State-Trait Anxiety Inventory was used to measure pre- and post-intervention anxiety. Results: There were no statistically significant differences in mean pre-intervention anxiety scores between the four groups (F = 0.31; P = 0.81). In contrast, there was a significant reduction in post-intervention anxiety among all three intervention groups compared to the control group (F = 27.71; P <0.01); however, there was no significant difference in anxiety level in terms of the type of intervention used. Conclusion: Peer, video and combined peer-and-video education were equally effective in reducing angiography-related patient anxiety. Such techniques are recommended to reduce anxiety amongst patients undergoing coronary angiography in hospitals in Iran.

scholarly journals The Effectiveness of Online Course Intervention to Improve Knowledge of Antimicrobial Resistance among Dental Students, in Comparison to Reference Group Using a Randomized Controlled Trial

2019 ◽  
Vol 7 (17) ◽  
pp. 2917-2923
Author(s):  
Khalid T. Aboalshamat ◽  
Assim M. Banjar ◽  
Mahmoud I. Al-Jaber ◽  
Noor M. Turkistani ◽  
Mohammed T. Al-Amoudi
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Dental Students ◽  
Online Course ◽  
Control Group ◽  
Study Group ◽  
Control Groups ◽  
Significant Difference ◽  
Randomised Controlled ◽  
And Control

AIM: This study aimed to assess the effectiveness of a recognised antimicrobial resistance (AMR) online module on knowledge and perception among dental students, using a randomised controlled trial study design. METHODS: Dental students (n = 64, aged 21-25 years) in clinical years agreed to participate in this triple-blinded, parallel, randomised controlled trial. There were 34 students in the study group and 30 students in the control group. The study group participated in an online course covering information about AMR, while students in the control group received another online course about microorganisms in dentistry. Both groups were assessed three times using online questionnaires: before the intervention (T1), after the intervention (T2), and two months later (T3). Each one of T1, T2 and T3 had 22 questions. The questions were repeated each time in T1, T2, and T3 asking about AMR but with different question format, to avoid the possibility of students to memorise the answers. RESULTS: The mean (m) of correct answers for all students on T1 was 12.56, with standard deviation (SD) of 3.2. On T2, m = 14.03 and SD = 3.85, and on T3, m = 14.36 and SD = 3.71. Scores ranged from 0 to 22. The participants in the study and control groups showed significant score improvements from T1 to T2, immediately after the intervention, but there was no significant difference between T2 and T3. The study group students’ scores did not improve significantly from T1 to T3, in contrast to the control group students’ scores. More importantly, there was no significant difference in improvement from T1 to T2 when comparing the study and control groups. CONCLUSION: Online courses might not be reliable learning methods for ensuring the optimal levels of AMR knowledge that are needed by dental practitioners.

Comparison of the efficacy of Acupuncture and Conventional Physiotherapy treatment in the management of SIJ dysfunction- A Randomised controlled trial (RCT)

2016 ◽  
Author(s):  
Ganiyu Oluwaleke Sokunbi ◽  
Fatima Gujba Kachalla
Keyword(s):  
Pain Intensity ◽  
Functional Disability ◽  
Controlled Trial ◽  
Control Group ◽  
Invasive Treatment ◽  
Pain Scores ◽  
Significant Difference ◽  
Conventional Physiotherapy ◽  
Randomised Controlled

Background: The question of what form of non-invasive treatment is most effective for sacroiliac joint (SIJ) dysfunction has not been sufficiently addressed. The quality of evidence regarding the efficacy of a conservative treatment approach is low, and there is no evidence for sustained benefits.Objectives: To compare the efficacy of acupuncture and conventional physiotherapy in the management of pain and functional disability in patients with SIJ dysfunction.Methods: Forty women with SIJ dysfunction with a mean age of 29.3± 4.3 years participated in the study. Ten participants were randomised into each of three intervention groups (acupuncture (ACT); conventional physiotherapy (CPT); and acupuncture combined with conventional physiotherapy (ACPT)) and a control group (CG) (education and advice). Treatment interventions were provided three times a week for five weeks. The main outcome measures were pain intensity measured with visual analogue scale (VAS) and functional disability measured with Roland Morris Disability Questionnaire (RMDQ). Assessments were carried out by an independent examiner before and after the intervention and at 3 months follow-up.Results: Baseline VAS and RMDQ scores did not show significant differences among the groups. After treatment, the participants in all the intervention groups had reduced pain scores on the VAS scale (ACT= 3.5±0.06, CPT =3.0±0.08 and ACPT=1.2±0.98) and improved function on RMDQ scores (ACT =7.0±1.53, CPT = 6.0±.01, ACPT = 3.0± 0.08) compared to those in the control group, who recorded 7.4±0.08 and 17.5± 4.32 for pain intensity and functional disability, respectively. However, pain reduction and improvement in function was greatest in the ACPT at the end of the 5-week treatment and at 3-month follow-up (VAS=1.0±0.04, RMDQ =2.0± 0.07) compared with the other intervention groups (VAS: ACT= 4.0±0.97, CPT = 3.5±1.00 and RMDQ: ACT=7.0±1.6, CPT=5.0±0.87). There was a significant difference in the pain scores on VAS (F =67.171, P=0.000) and functional disability on RMDQ scores (F=62.467, P=0.000) among the groups after 5 weeks of treatment and at 3-month post-treatment follow-up assessment VAS (F =79.903, P=0.000) and RMDQ (F =75.301, P=0.000), which was not present at the baseline.Conclusion: Findings from this study showed that acupuncture or conventional physiotherapy alone or in combination is more effective than advice and education. The combination of acupuncture and conventional therapy is more effective than both treatments alone.

A randomised controlled trial comparing compression therapy after stripping for primary great saphenous vein incompetence

2019 ◽  
Vol 34 (10) ◽  
pp. 669-674 ◽  
Author(s):  
Attila G Krasznai ◽  
Tim A Sigterman ◽  
Janine P Houtermans-Auckel ◽  
Ed Eussen ◽  
Maarten Snoeijs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Saphenous Vein ◽  
Great Saphenous Vein ◽  
Controlled Trial ◽  
Compression Therapy ◽  
Full Recovery ◽  
Control Group ◽  
Post Operative Pain ◽  
Significant Difference ◽  
Randomised Controlled

Background Venous insufficiency of the lower extremity affects up to 40–60% of general adult population in the Western population, of which around 25% has varicose veins mostly treated by ablation of the incompetent great saphenous vein. Although endovenous options are available, the majority is still treated with stripping of the great saphenous vein for which there is no consensus regarding postoperative compressive therapy. The objective of this prospective randomised controlled trial was to evaluate 4 h compared to 72 h of leg compression after great saphenous vein stripping. Method Patients in the Zuyderland Medical Centre with an indication for stripping of the great saphenous vein were eligible for inclusion in this study. Patients were randomised to 4 or 72 h of leg compression (standard elastic bandaging) after stripping of the great saphenous vein. Primary outcome was change in leg volume after 14 days. Secondary outcomes were post-operative pain scores, complications and time to full recovery. Results A total of 78 patients were randomised, 36 patients enrolled the intervention (4 h) group and 42 patients the control group (72 h). The intervention group (4 h) showed a 57 mL reduction in leg volume after 14 days, compared to 6 mL of the control group (72 h) ( p = 0.11). Post-operative pain, complications and time to full recovery did not statistically differ. Conclusion Wearing leg compression four hours after stripping is non-inferior in preventing leg oedema compared with 72 h compression therapy. No statistically significant difference in pain and time to full recovery was shown.

scholarly journals Use of a Human Patient Simulator to Improve Physiotherapy Cardiorespiratory Clinical Skills in Undergraduate Physiotherapy Students: A Randomised Controlled Trial

2011 ◽  
Author(s):  
Anne Jones ◽  
Lorraine Sheppard
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Simulator Training ◽  
Control Group ◽  
Human Patient ◽  
Patient Simulator ◽  
Significant Difference ◽  
Human Patient Simulator ◽  
Randomised Controlled ◽  
Physiotherapy Students

To investigate whether additional training with a human patient simulator improves cardiorespiratory physiotherapy practice in undergraduate physiotherapy students. Method: A randomised controlled trial was undertaken with 50 third year physiotherapy students from James Cook University, Queensland Australia. Participants in the intervention group underwent two four hour sessions of patient simulator training in addition to their normal cardiorespiratory physiotherapy training prior to attending clinical placements. Participants in both the intervention and control groups were assessed weekly for six weeks on their clinical ability whilst on clinical placement. Results: Mann-Whitney was used to compare the training group with the control group. No significant difference was found between groups.Conclusion: This study indicates that simulation, as undertaken in this manner, does not improve clinical ability in cardiorespiratory physiotherapy. Further studies are needed to determine if more training time is required, or whether simulation must be fully integrated into the curriculum.

scholarly journals Prospective economic evaluation of an electronic discharge communication tool: analysis of a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e019139 ◽  
Author(s):  
Laura K Sevick ◽  
Maria-Jose Santana ◽  
William A Ghali ◽  
Fiona Clement
Keyword(s):  
Economic Evaluation ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Communication Tool ◽  
Randomised Controlled ◽  
The Cost ◽  
Discharge Communication

ObjectiveTo complete an economic evaluation within a randomised controlled trial (RCT) comparing the use of an electronic discharge communication tool (eDCT) compared with usual care.SettingPatients being discharged from a single tertiary care centre’s internal medicine Medical Teaching Units.ParticipantsBetween January 2012 and December 2013, 1399 patients were randomised to a discharge mechanism. Forty-five patients were excluded from the economic evaluation as they did not have data for the index hospitalisation cost; 1354 patients contributed to the economic evaluation.InterventioneDCT generated at discharge containing structured content on reason for admission, details of the hospital stay, treatments received and follow-up care required. The control group was discharged via traditional dictation methods.Primary and secondary outcome measuresThe primary economic outcome was the cost per quality-adjusted life year (QALY) gained. Secondary outcomes included the cost per death avoided and the cost per readmission avoided.ResultsThe average transcription cost was $C22.28 per patient, whereas the estimated cost of the eDCT was $C13.33 per patient. The cost per QALY gained was $C239 933 in the eDCT arm compared with usual care due to the very small gains in effectiveness and approximately $C800difference in resource utilisation costs. The bootstrap analyses resulted in eDCT being more effective and more costly in 29.2% of samples, less costly and more effective in 29.2% of samples, less effective and more costly in 23.9% of samples and finally, less costly and less effective in 17.7% of samples.ConclusionsThe eDCT reduced per patient costs of the generation of discharge summaries. The bootstrap estimates demonstrate considerable uncertainty supporting the finding of neutrality reported in the clinical component of the RCT. The immediate transcription cost savings and previously documented provider and patient satisfaction may increase the impetus for organisations to invest in such systems, provided they have a foundation of eHealth infrastructure and readiness.Trial registration numberNCT01402609.

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