scholarly journals Results of a pilot randomised controlled trial to measure the clinical and cost effectiveness of peer support in increasing hope and quality of life in mental health patients discharged from hospital in the UK

2014 ◽  
Vol 14 (1) ◽  
Author(s):  
Alan Simpson ◽  
Chris Flood ◽  
Julie Rowe ◽  
Jody Quigley ◽  
Susan Henry ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Pilot Randomised Controlled Trial ◽  
Mental Health Patients ◽  
Randomised Controlled ◽  
The Uk

scholarly journals Stress Management in Elementary School Students: a Pilot Randomised Controlled Trial

2021 ◽  
Vol 26 (1) ◽  
pp. e976
Author(s):  
Katerina Sofianopoulou ◽  
Flora Bacopoulou ◽  
Dimitrios Vlachakis ◽  
Ioulia Kokka ◽  
Evaggelos Alexopoulos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Elementary School ◽  
Randomised Controlled Trial ◽  
Elementary School Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
School Students ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Research has shown that stress experiences begin in early stages of life. Stress management techniques have appeared to be beneficial for the development or enhancement of stress coping skills. The aim of this pilot randomised controlled trial was to assess the effect of a 12-week intervention, comprising training in diaphragmatic breathing and progressive muscular relaxation, on elementary school students’ stress levels. Outcomes on the quality of life and behavioural aspects of the students were also assessed. Standardised questionnaires were administered at baseline and after the 12-week intervention program. Fifty-two children aged 10 to 11 years were randomly assigned to intervention (n=24) and control groups (n=28). Children of the intervention group demonstrated lower levels of stress (in all three subscales of lack of well-being, distress, and lack of social support) and improved aspects of quality of life (physical, emotional, and school functioning). No significant differences were observed regarding the examined behavioural dimensions, in the intervention group. Larger randomised controlled trials with follow-up evaluations are needed to ascertain the positive outcomes of such programs on elementary school children.

scholarly journals SOMA-trial: surgery or medication for women with an endometrioma? Study protocol for a randomised controlled trial and cohort study

2020 ◽  
Vol 2020 (1) ◽  
Author(s):  
E van Barneveld ◽  
V B Veth ◽  
J M Sampat ◽  
A M F Schreurs ◽  
M van Wely ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Deep Endometriosis ◽  
Ovarian Endometrioma ◽  
Randomised Controlled

Abstract STUDY QUESTIONS The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical treatment of women suffering from pain due to an ovarian endometrioma when compared to treatment with medication (analgesia and/or hormones). The primary outcome is defined as successful pain reduction (−30% reduction of pain) measured by the numeric rating scale (NRS) after 6 months. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life, affective symptoms, cost-effectiveness, recurrence rate, need of adjuvant medication after surgery, ovarian reserve, adjuvant surgery and budget impact. WHAT IS KNOWN ALREADY Evidence suggests that both medication and surgical treatment of an ovarian endometrioma are effective in reducing pain and improving quality of life. However, there are no randomised studies that compare surgery to treatment with medication. STUDY DESIGN, SIZE, DURATION This study will be performed in a research network of university and teaching hospitals in the Netherlands. A multicentre randomised controlled trial and parallel prospective cohort study in patients with an ovarian endometrioma, with the exclusion of patients with deep endometriosis, will be conducted. After obtaining informed consent, eligible patients will be randomly allocated to either treatment arm (medication or surgery) by using web-based block randomisation stratified per centre. A successful pain reduction is set at a 30% decrease on the NRS at 6 months after randomisation. Based on a power of 80% and an alpha of 5% and using a continuity correction, a sample size of 69 patients in each treatment arm is needed. Accounting for a drop-out rate of 25% (i.e. loss to follow up), we need to include 92 patients in each treatment arm, i.e. 184 in total. Simultaneously, a cohort study will be performed for eligible patients who are not willing to be randomised because of a distinct preference for one of the two treatment arms. We intend to include 100 women in each treatment arm to enable standardization by inverse probability weighting, which means 200 patients in total. The expected inclusion period is 24 months with a follow-up of 18 months. PARTICIPANTS/MATERIALS, SETTING, METHODS Premenopausal women (age ≥ 18 years) with pain (dysmenorrhoea, pelvic pain or dyspareunia) and an ovarian endometrioma (cyst diameter ≥ 3 cm) who visit the outpatient clinic will make up the study population. Patients with signs of deep endometriosis will be excluded. The primary outcome is successful pain reduction, which is defined as a 30% decrease of pain on the NRS at 6 months after randomisation. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life and affective symptoms, cost-effectiveness (from a healthcare and societal perspective), number of participants needing additional surgery, need of adjuvant medication after surgery, ovarian reserve and recurrence rate of endometriomas. Measurements will be performed at baseline, 6 weeks and 6, 12 and 18 months after randomisation. STUDY FUNDING/COMPETING INTEREST(S) This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-85200-98-91041. The Department of Reproductive Medicine of the Amsterdam UMC location VUmc has received several research and educational grants from Guerbet, Merck KGaA and Ferring not related to the submitted work. B.W.J. Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for ObsEva, Merck KGaA and Guerbet. V. Mijatovic reports grants from Guerbet, grants from Merck and grants from Ferring outside the submitted work. All authors declare that they have no competing interests concerning this publication. TRIAL REGISTRATION NUMBER Dutch Trial Register (NTR 7447, http://www.trialregister.nl). TRIAL REGISTRATION DATE 2 January 2019 DATE OF FIRST PATIENT’S ENROLMENT First inclusion in randomised controlled trial October 4, 2019. First inclusion in cohort May 22, 2019.

scholarly journals Effect of occupation-based interventions in patients with haematopoietic malignancies undergoing chemotherapy: A pilot randomised controlled trial

2018 ◽  
Vol 31 (2) ◽  
pp. 97-105
Author(s):  
Akira Sagari ◽  
Yuta Ikio ◽  
Nobuko Imamura ◽  
Kayoko Deguchi ◽  
Toko Sakai ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Decision Making ◽  
Randomised Controlled Trial ◽  
Activities Of Daily Living ◽  
Daily Living ◽  
Controlled Trial ◽  
Intervention Group ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Background/objective Chemotherapy for cancer negatively affects activities of daily living and quality of life. This study aimed to validate and compare the efficacy of two different interventions in patients with haematopoietic malignancies undergoing chemotherapy: (1) occupation-based interventions, designed using the Aid for Decision-making in Occupation Choice (ADOC) (an iPAD application) and (2) impairment-based interventions. ADOC helps promote decision-making during activities and participation in occupation-based goal setting. The impairment-based intervention group served as the comparison group and underwent impairment-based interventions focusing on dysfunction. Methods In this single-blinded pilot randomised controlled trial, 19 participants received an occupation-based intervention (n = 9) or an impairment-based intervention (n = 10). The treatment period comprised two sessions. Recruitment, compliance and outcome completion rates were calculated for the study. Effect sizes were examined for outcomes regarding physical performance, instrumental activities of daily living and quality of life as evaluated by a blinded assessor. Results In this study, 24.8% (28/113) of the eligible patients with haematopoietic malignancies were enrolled, and 67.9% (19/28) of these were retained up to the post-assessment stage. Recruitment (25%) and compliance (68%) rates were satisfactory. The Functional Assessment of Cancer Therapy-General emotional well-being and total scores were significantly higher for the occupation-based intervention group than for the impairment-based intervention group (both p < 0.05; d = 0.54, d = 0.51, respectively). Other outcomes showed no significant differences. Conclusion Occupation-based interventions designed using the ADOC application were useful for patients with haematopoietic malignancies.

scholarly journals A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study

2017 ◽  
Vol 21 (70) ◽  
pp. 1-224 ◽  
Author(s):  
Angus JM Watson ◽  
Jonathan Cook ◽  
Jemma Hudson ◽  
Mary Kilonzo ◽  
Jessica Wood ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Stapled Haemorrhoidopexy ◽  
Short Term ◽  
Haemorrhoidal Disease ◽  
Randomised Controlled ◽  
The Uk ◽  
To Receive

BackgroundHaemorrhoids are a benign anorectal condition and are highly prevalent in the UK population. Treatments involve clinic-based procedures and surgery. The surgical procedures available include stapled haemorrhoidopexy (SH) and traditional haemorrhoidectomy (TH), and over 25,000 operations are performed for haemorrhoids annually in the UK. The disease is therefore important both to patients and to health service commissioners. Debate remains as to which of these surgical procedures is the most clinically effective and cost-effective.ObjectiveThe aim of this study was to compare the clinical effectiveness and cost-effectiveness of SH with that of TH.DesignA large, open two-arm parallel-group pragmatic multicentre randomised controlled trial involving 32 UK hospitals and a within-trial cost–benefit analysis. A discrete choice experiment was conducted to estimate benefits (willingness to pay).ParticipantsPatients with grades II–IV haemorrhoids who had not previously undergone SH or TH were included in the study.InterventionsParticipants were randomised to receive either SH or TH. Randomisation was minimised at 1 : 1, in accordance with baseline EuroQol-5 Dimensions, three-level version (EQ-5D-3L) score, haemorrhoid grade, sex and centre, via an automated system.Main outcome measuresThe primary outcome was area under the quality-of-life curve measured using the EQ-5D-3L descriptive system over 24 months, and the primary economic outcome was the incremental cost-effectiveness ratio. Secondary outcomes included disease-specific quality of life, recurrence, complications, further interventions and costs.ResultsBetween January 2011 and August 2014, 777 patients were randomised (389 to receive SH and 388 to receive TH). There were 774 participants included in the analysis as a result of one post-randomisation exclusion in the SH arm and two in the TH arm. SH was less painful than TH in the short term. Surgical complications were similar in both arms. EQ-5D-3L score was higher for the SH arm in the first 6 weeks after surgery, but over 24 months the TH group had significantly better EQ-5D-3L scores (–0.073, 95% confidence interval –0.140 to –0.006;p = 0.0342). Symptoms and further interventions were significantly fewer in the TH arm at 24 months. Continence was better in the TH arm and tenesmus occurred less frequently. The number of serious adverse events reported was 24 out of 337 (7.1%) for participants who received SH and 33 out of 352 (9.4%) for those who received TH. There were two deaths in the SH arm, both unrelated to the eTHoS (either Traditional Haemorrhoidectomy or Stapled haemorrhoidopexy for haemorrhoidal disease) study. Patient preference did not seem to influence the treatment difference. SH was dominated by TH as it cost more and was less effective. The net benefit for the TH arm was higher than that for the SH arm.LimitationsNeither the participants nor the assessors were masked to treatment assignment and final recruitment was slightly short of the total target of 800. There were also substantial missing follow-up data.ConclusionsWhile patients who received SH had less short-term pain, after 6 weeks, recurrence rates, symptoms, re-interventions and quality-of-life measures all favoured TH. In addition, TH is cheaper. As part of a tailored management plan for haemorrhoids, TH should be considered over SH as the surgical treatment of choice for haemorrhoids refractory to clinic-based interventions.Future workPerform an updated meta-analysis incorporating recently conducted European trials [eTHoS, HubBLe (haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids) and LingaLongo (Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease)].Trial registrationCurrent Controlled Trials ISRCTN80061723.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 70. See the NIHR Journals Library website for further project information.

scholarly journals Clinical effectiveness and cost-effectiveness of physiotherapy and occupational therapy versus no therapy in mild to moderate Parkinson’s disease: a large pragmatic randomised controlled trial (PD REHAB)

2016 ◽  
Vol 20 (63) ◽  
pp. 1-96 ◽  
Author(s):  
Carl E Clarke ◽  
Smitaa Patel ◽  
Natalie Ives ◽  
Caroline E Rick ◽  
Rebecca Woolley ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Cost Effectiveness ◽  
Adverse Events ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Randomised Controlled ◽  
The Uk

BackgroundCochrane reviews of physiotherapy (PT) and occupational therapy (OT) for Parkinson’s disease found insufficient evidence of effectiveness, but previous trials were methodologically flawed with small sample size and short-term follow-up.ObjectivesTo evaluate the clinical effectiveness and cost-effectiveness of individualised PT and OT in Parkinson’s disease.DesignLarge pragmatic randomised controlled trial.SettingThirty-eight neurology and geriatric medicine outpatient clinics in the UK.ParticipantsSeven hundred and sixty-two patients with mild to moderate Parkinson’s disease reporting limitations in activities of daily living (ADL).InterventionPatients were randomised online to either both PT and OT NHS services (n = 381) or no therapy (n = 381). Therapy incorporated a patient-centred approach with individual assessment and goal setting.Main outcome measuresThe primary outcome was instrumental ADL measured by the patient-completed Nottingham Extended Activities of Daily Living (NEADL) scale at 3 months after randomisation. Secondary outcomes were health-related quality of life [Parkinson’s Disease Questionnaire-39 (PDQ-39); European Quality of Life-5 Dimensions (EQ-5D)], adverse events, resource use and carer quality of life (Short Form questionnaire-12 items). Outcomes were assessed before randomisation and at 3, 9 and 15 months after randomisation.ResultsData from 92% of the participants in each group were available at the primary time point of 3 months, but there was no difference in NEADL total score [difference 0.5 points, 95% confidence interval (CI) –0.7 to 1.7;p = 0.4] or PDQ-39 summary index (0.007 points, 95% CI –1.5 to 1.5;p = 1.0) between groups. The EQ-5D quotient was of borderline significance in favour of therapy (–0.03, 95% CI –0.07 to –0.002;p = 0.04). Contact time with therapists was for a median of four visits of 58 minutes each over 8 weeks (mean dose 232 minutes). Repeated measures analysis including all time points showed no difference in NEADL total score, but PDQ-39 summary index (curves diverging at 1.6 points per annum, 95% CI 0.47 to 2.62;p = 0.005) and EQ-5D quotient (0.02, 95% CI 0.00007 to 0.03;p = 0.04) showed significant but small differences in favour of the therapy arm. Cost-effective analysis showed that therapy was associated with a slight but not significant gain in quality-adjusted life-years (0.027, 95% CI –0.010 to 0.065) at a small incremental cost (£164, 95% CI –£141 to £468), resulting in an incremental cost-effectiveness ratio of under £4000 (£3493, 95% –£169,371 to £176,358). There was no difference in adverse events or serious adverse events.ConclusionsNHS PT and OT did not produce immediate or long-term clinically meaningful improvements in ADL or quality of life in patients with mild to moderate Parkinson’s disease. This evidence does not support the use of low-dose, patient-centred, goal-directed PT and OT in patients in the early stages of Parkinson’s disease. Future research should include the development and testing of more structured and intensive PT and OT programmes in patients with all stages of Parkinson’s disease.Trial registrationCurrent Controlled Trials ISRCTN17452402.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 63. See the NIHR Journals Library website for further project information. The Birmingham Clinical Trials Unit, University of Birmingham, received support from the UK Department of Health up to March 2012. Catherine Sackley was supported by a NIHR senior investigator award, Collaboration for Leadership in Applied Health Research and Care East of England and West Midlands Strategic Health Authority Clinical Academic Training award.

scholarly journals Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology

2017 ◽  
Vol 102 (5) ◽  
pp. 593-598 ◽  
Author(s):  
Gus Gazzard ◽  
Evgenia Konstantakopoulou ◽  
David Garway-Heath ◽  
Keith Barton ◽  
Richard Wormald ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Ocular Hypertension ◽  
Medical Therapy ◽  
Initial Treatment ◽  
Open Angle Glaucoma ◽  
Controlled Trial ◽  
Randomised Controlled

PurposeThe Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT).DesignThe LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis.ConclusionsThe LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication.Trial registration numberISRCTN32038223, Pre-results.

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