Efficacy of Heroin-Assisted Treatment in Belgium: A Randomised Controlled Trial

2015 ◽  
Vol 21 (4) ◽  
pp. 179-187 ◽  
Author(s):  
Isabelle Demaret ◽  
Etienne Quertemont ◽  
Géraldine Litran ◽  
Cécile Magoga ◽  
Clémence Deblire ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Methadone Maintenance ◽  
Controlled Trial ◽  
Methadone Treatment ◽  
Control Group ◽  
Heroin Addicts ◽  
Heroin Use ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Experimental Group

Background/Aims: Heroin-assisted treatment (HAT) can improve the condition of heroin addicts still using street heroin after a methadone treatment. In Belgium, a new trial compared the efficacy of a HAT to existing methadone maintenance treatment. Methods: In this randomised controlled trial, HAT was limited to 12 months. Participants were assessed every 3 months. They were responders if they showed improvement on the level of street heroin use, health or criminal involvement. Results: 74 participants were randomised in the trial. The experimental group (n = 36) counted 30% of responders more than the control group (n = 38) at each assessment point (p < 0.05), except at 12 months where the difference (11%) was no longer significant (p = 0.35). Still, after 12 months, participants in the experimental group reported significantly greater improvements (p < 0.05) than the control group on the level of street heroin use and on the level of physical and mental health. Both groups reported significantly less criminal acts after 12 months (p < 0.001), but with no significant difference between the groups. Conclusions: This trial confirms the short-term efficacy of HAT for severe heroin addicts, who already failed methadone treatment.

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 an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial

2020 ◽  
Vol 7 (1) ◽  
pp. e000376
Author(s):  
Sivakami Janahiraman ◽  
Chan Yen Tay ◽  
Jie Min Lee ◽  
Wen Ling Lim ◽  
Chun Hoe Khiew ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Educational Programme ◽  
Control Group ◽  
Randomised Controlled ◽  
The Impact ◽  
Experimental Group

ObjectivePreprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.DesignAn accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).ResultsA total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).ConclusionAn intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.

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 A randomised controlled trial of innovative specialised meat product for patients with cardiovascular and metabolic disorders

10.5219/1298 ◽  
2020 ◽  
Vol 14 ◽  
pp. 458-464
Author(s):  
Irina Chernukha ◽  
Elena Kotenkova
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Meat Product ◽  
Meat Products ◽  
Density Lipoprotein ◽  
Control Group ◽  
Low Calorie Diet ◽  
Calorie Diet ◽  
Randomised Controlled ◽  
Experimental Group

Cardiovascular diseases remain one of the leading causes of death globally. A lot of dietary patterns for CVD prevention have been proposed, but special attention is paid to functional foods. Bioactive proteins and peptides from animal sources are also considered tools for the prevention of CVDs. Here, 40 overweight or obese adult men and women aged between 61 and 66 years, with a body-mass index between 28 and 61 kg.m-2, were enrolled into a randomised controlled trial of new meat products for specialised nutrition. Participants in the control group (n = 20) consumed a standard hyponatric low-calorie diet for 28-30 days (10 days inpatient and 18-20 days outpatient), and in the experimental group – a low-calorie diet and 100g developed meat product (ratio of the porcine aorta to hearts 1:3) per day. Total cholesterol, triglyceride, cholesterol low-density lipoprotein, and cholesterol high-density lipoprotein levels were measured in the serum; from this, the atherogenic index was calculated. The positive effect of developed meat products on the serum lipid profile of patients during the trial was mild but noticeable. A significant reduction in cholesterol levels was noticed in the experimental group, by 18.2% and 14.0% after 7 – 10 and 28 – 30 days, respectively, while the cholesterol level in the control group returned to its original level after 28 – 30 days of dieting. The difference between the control and experimental groups was not significant, while data in the percentiles were. Therefore, it is more preferable to use a developed product as a component in diet therapy for hyperlipidaemic humans for over 28 – 30 days. Pronounced effects of the product could be linked to the unique proteome and peptidome of heart and aorta tissues based on organ-specific gene expression and the presence of tissue-specific substances.

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.

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 Effect of a structured educational intervention on explanatory models of relatives of patients with schizophrenia

2006 ◽  
Vol 188 (3) ◽  
pp. 286-287 ◽  
Author(s):  
S. Das ◽  
B. Saravanan ◽  
K. P. Karunakaran ◽  
S. Manoranjitham ◽  
P. Ezhilarasu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Educational Programme ◽  
Explanatory Models ◽  
Control Group ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Biomedical Treatment ◽  
Trial Participants

SummaryWe examined the effect of a structured educational programme on explanatory models of illness among the relatives of people with schizophrenia, in a randomised controlled trial. Participants were assessed at baseline (n=100) and after 2 weeks (n=75) using a vignette from the Short Explanatory Model Interview. There was a reduction in non-biomedical causal explanatory models at follow-up among those who had completed the structured educational programme compared with the control group. There was no significant difference in non-biomedical treatment explanatory models between the two groups.

scholarly journals Comparison of autologous osteoperiosteal cylinder and osteochondral graft transplantation in the treatment of large cystic osteochondral lesions of the talus (OLTs): a protocol for a non-inferiority randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033850 ◽  
Author(s):  
En Deng ◽  
Weili Shi ◽  
Yanfang Jiang ◽  
Qinwei Guo
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Donor Site ◽  
Donor Site Morbidity ◽  
Control Group ◽  
Osteochondral Lesions ◽  
Osteochondral Transplantation ◽  
Autologous Osteochondral Transplantation ◽  
Randomised Controlled ◽  
Experimental Group

IntroductionLarge cystic osteochondral lesions of the talus (OLTs) have been shown to have inferior clinical outcomes after reparative techniques such as bone marrow stimulation. Autologous osteochondral transplantation has been viewed as an alternative choice for treating these lesions, but donor-site morbidity has limited its application. Excellent clinical outcomes have been shown in repairing these types of lesions with autologous osteoperiosteal grafts, and these outcomes are achieved at a low cost and without donor-site morbidity in the normal knee joint. This will be the first randomised controlled trial to compare the two surgical techniques, and recommendations for the treatment of patients with large cystic OLTs will be provided.Methods and analysisA non-inferiority randomised controlled trial will be conducted. A total of 70 participants with clinically diagnosed large cystic OLTs will be randomly allocated to either the experimental group or the control group at a ratio of 1:1. The experimental group will be treated with autologous osteoperiosteal cylinder graft transplantation, while the control group will be treated with autologous osteochondral transplantation. The primary outcome measure will be the American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Score and the Short Form 12 (SF-12) questionnaire. Secondary outcome measures will include the secondary arthroscopy International Cartilage Repair Society score, the Magnetic Resonance Observation of Cartilage Repair Tissue score, the Tegner activity level score, the visual analogue scale, routine X-rays, CT and complications. These parameters will be evaluated preoperatively, as well as at 3, 6, 12, 24, 36 and 60 months postoperatively. In this trial, we hypothesised that both procedures offer good results for the treatment of patients with large cystic OLTs, and occurrence of donor-site morbidity in autologous osteoperiosteal cylinder graft transplantation group is less than that in autologous osteochondral transplantation group.Ethics and disseminationThe current study was approved by the board of research ethics of Peking University Third Hospital Medical Science Research Ethics Committee. The results of this study will be presented at national and international conferences and published in peer-reviewed journals.Trial registration numberNCT03347877.

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