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

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.

Download Full-text

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

The British Journal of Psychiatry ◽

10.1192/bjp.bp.104.007245 ◽

2006 ◽

Vol 188 (3) ◽

pp. 286-287 ◽

Cited By ~ 34

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.

Download Full-text

Effectiveness of a volunteer befriending programme for patients with schizophrenia: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.2019.42 ◽

2019 ◽

Vol 217 (3) ◽

pp. 477-483 ◽

Cited By ~ 9

Author(s):

Stefan Priebe ◽

Agnes Chevalier ◽

Thomas Hamborg ◽

Eoin Golden ◽

Michael King ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Social Isolation ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Social Contacts ◽

Significant Difference ◽

Randomised Controlled

BackgroundBefriending by volunteers has the potential to reduce the frequent social isolation of patients with schizophrenia and thus improve health outcomes. However, trial-based evidence for its effectiveness is limited.AimsTo conduct a randomised controlled trial of befriending for patients with schizophrenia or related disorders.MethodPatients were randomised to a befriending programme for 1 year or to receive information about social activities only (trial registration: ISRCTN14021839). Outcomes were assessed masked to allocation at the end of the programme; at 12 months and at a 6-month follow-up. The primary outcome was daily time spent in activities (using the Time Use Survey (TUS)) with intention-to-treat analysis.ResultsA total of 124 patients were randomised (63 intervention, 61 active control) and 92 (74%) were followed up at 1 year. In the intervention group, 49 (78%) met a volunteer at least once and 31 (49%) had more than 12 meetings. At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI −40.7 to 58.5, P = 0.72). There were no significant differences in quality of life, symptoms or self-esteem. However, patients in the intervention group had significantly more social contacts than those in the control group at the end of the 12-month period. This difference held true at the follow-up 6 months later.ConclusionsAlthough no difference was found on the primary outcome, the findings suggest that befriending may have a lasting effect on increasing social contacts. It may be used more widely to reduce the social isolation of patients with schizophrenia.

Download Full-text

Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

Scientific Reports ◽

10.1038/s41598-021-94892-0 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Anna-Lotta Irewall ◽

Anders Ulvenstam ◽

Anna Graipe ◽

Joachim Ögren ◽

Thomas Mooe

Keyword(s):

Randomised Controlled Trial ◽

Primary Endpoint ◽

Cardiovascular Events ◽

Controlled Trial ◽

Control Group ◽

Coronary Syndrome ◽

Secondary Endpoints ◽

Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

Download Full-text

A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽

10.3390/healthcare9070910 ◽

2021 ◽

Vol 9 (7) ◽

pp. 910

Author(s):

Dorthe Djernis ◽

Mia S. O’Toole ◽

Lone O. Fjorback ◽

Helle Svenningsen ◽

Mimi Y. Mehlsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Effect Sizes ◽

Medium Effect ◽

Control Group ◽

Post Intervention ◽

Pilot Randomised Controlled Trial ◽

Self Compassion ◽

Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

Download Full-text

Functional electrical stimulation‐assisted cycle ergometry-based progressive mobility programme for mechanically ventilated patients: randomised controlled trial with 6 months follow-up

Thorax ◽

10.1136/thoraxjnl-2020-215755 ◽

2021 ◽

pp. thoraxjnl-2020-215755

Author(s):

Petr Waldauf ◽

Natália Hrušková ◽

Barbora Blahutova ◽

Jan Gojda ◽

Tomáš Urban ◽

...

Keyword(s):

Electrical Stimulation ◽

Randomised Controlled Trial ◽

Functional Electrical Stimulation ◽

Controlled Trial ◽

Cycle Ergometry ◽

Control Group ◽

Mechanically Ventilated ◽

Icu Discharge ◽

Randomised Controlled

PurposeFunctional electrical stimulation-assisted cycle ergometry (FESCE) enables in-bed leg exercise independently of patients’ volition. We hypothesised that early use of FESCE-based progressive mobility programme improves physical function in survivors of critical care after 6 months.MethodsWe enrolled mechanically ventilated adults estimated to need >7 days of intensive care unit (ICU) stay into an assessor-blinded single centre randomised controlled trial to receive either FESCE-based protocolised or standard rehabilitation that continued up to day 28 or ICU discharge.ResultsWe randomised in 1:1 ratio 150 patients (age 61±15 years, Acute Physiology and Chronic Health Evaluation II 21±7) at a median of 21 (IQR 19–43) hours after admission to ICU. Mean rehabilitation duration of rehabilitation delivered to intervention versus control group was 82 (IQR 66–97) versus 53 (IQR 50–57) min per treatment day, p<0.001. At 6 months 42 (56%) and 46 (61%) patients in interventional and control groups, respectively, were alive and available to follow-up (81.5% of prespecified sample size). Their Physical Component Summary of SF-36 (primary outcome) was not different at 6 months (50 (IQR 21–69) vs 49 (IQR 26–77); p=0.26). At ICU discharge, there were no differences in the ICU length of stay, functional performance, rectus femoris cross-sectional diameter or muscle power despite the daily nitrogen balance was being 0.6 (95% CI 0.2 to 1.0; p=0.004) gN/m2 less negative in the intervention group.ConclusionEarly delivery of FESCE-based protocolised rehabilitation to ICU patients does not improve physical functioning at 6 months in survivors.Trial registration numberNCT02864745.

Download Full-text

Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00788-1 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Laura Williams ◽

Charlotte L. Hall ◽

Sue Brown ◽

Boliang Guo ◽

Marilyn James ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Young People ◽

Controlled Trial ◽

Medication Management ◽

Control Group ◽

Global Functioning ◽

Children And Young People ◽

Link Type ◽

Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

Download Full-text

A Randomised Controlled Trial of Strategies to Prompt Attendance for a Pap Smear

Journal of Medical Screening ◽

10.1177/096914139500200408 ◽

1995 ◽

Vol 2 (4) ◽

pp. 211-218 ◽

Cited By ~ 23

Author(s):

Jenny Bowman ◽

Rob Sanson-Fisher ◽

Catherine Boyle ◽

Stephanie Pope ◽

Sally Redman

Keyword(s):

At Risk ◽

Randomised Controlled Trial ◽

Pap Smear ◽

Controlled Trial ◽

Self Report ◽

Health Clinic ◽

Control Group ◽

Screening Attendance ◽

Randomised Controlled

Objective – To assess the comparative efficacy, by randomised controlled trial, of three interventions designed to encourage “at risk” women to have a Pap smear: an educational pamphlet; letters inviting attendance at a women's health clinic; and letters from physicians. Methods – Subjects at risk for cervical cancer who had not been adequately screened were identified by a random community survey and randomly allocated to one of the intervention groups or a control group. Six months after intervention implementation, a follow up survey assessed subsequent screening attendance. Self report was validated by comparison with a national screening data base. Results – A significantly greater proportion of women (36.9%) within the group receiving a physician letter reported screening at follow up than in any other group (P =0.012). The variables most strongly predicting screening attendance were: age, perceived frequency of screening required, use of oral contraceptives, and allocation to receive the physician letter intervention. Conclusions – The relative efficacy of the GP letter in prompting screening attendance shows that this strategy is worthy of further investigation. There remains a need to examine the barriers to screening for older women, and to develop tailored strategies for this population.

Download Full-text

Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial

PLoS ONE ◽

10.1371/journal.pone.0241704 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0241704

Author(s):

Jennifer Wild ◽

Shama El-Salahi ◽

Michelle Degli Esposti ◽

Graham R. Thew

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Self Report ◽

Post Traumatic Stress ◽

Emergency Responders ◽

Significant Difference ◽

Randomised Controlled ◽

Resilience Intervention

Background Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders’ wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers. Methods We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind’s group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions. Results A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure. Conclusions The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health. Trial registration ISRCTN registry, ISRCTN79407277.

Download Full-text

Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility

BMJ Open ◽

10.1136/bmjopen-2017-018409 ◽

2018 ◽

Vol 8 (2) ◽

pp. e018409 ◽

Cited By ~ 10

Author(s):

Sarah G Dean ◽

Leon Poltawski ◽

Anne Forster ◽

Rod S Taylor ◽

Anne Spencer ◽

...

Keyword(s):

Physical Activity ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cognitive Capacity ◽

Economic Evaluations ◽

Control Group ◽

Rehabilitation Training ◽

One To One ◽

Randomised Controlled

ObjectivesTo assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity.DesignA two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations.SettingCommunity settings across two sites in Devon.ParticipantsEligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported mobility issues, no contraindications to physical activity, discharged from National Health Service or any other formal rehabilitation programme at least 1 month before, willing to be randomised to either control or ReTrain and attend the training venue, possessing cognitive capacity and communication ability sufficient to participate. Participants were individually randomised (1:1) via a computer-generated randomisation sequence minimised for time since stroke and level of functional disability. Only outcome assessors independent of the research team were blinded to group allocation.InterventionsReTrain comprised (1) an introductory one-to-one session; (2) ten, twice-weekly group classes with up to two trainers and eight clients; (3) a closing one-to-one session, followed by three drop-in sessions over the subsequent 3 months. Participants received a bespoke home-based training programme. All participants received treatment as usual. The control group received an exercise after stroke advice booklet.Outcome measuresCandidate primary outcomes included functional mobility and physical activity.ResultsForty-five participants were randomised (ReTrain=23; Control=22); data were available from 40 participants at 6 months of follow-up (ReTrain=21; Control=19) and 41 at 9 months of follow-up (ReTrain=21; Control=20). We demonstrated ability to recruit and retain participants. Participants were not burdened by the requirements of the study. We were able to calculate sample estimates for candidate primary outcomes and test procedures for process and health economic evaluations.ConclusionsAll objectives were fulfilled and indicated that a definitive trial of ReTrain is feasible and acceptable.Trial registration numberNCT02429180; Results.

Download Full-text

The Nature stroke study; NASTRU - A randomised controlled trial of nature-based post-stroke fatigue rehabilitation

10.21203/rs.2.461/v1 ◽

2019 ◽

Author(s):

Anna María Pálsdóttir ◽

Kjerstin Stigmar ◽

Bo Norrving ◽

Patrik Grahn ◽

Ingemar F Petersson ◽

...

Keyword(s):

Quality Of Life ◽

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Perceived Value ◽

Control Group ◽

Post Stroke ◽

Randomised Controlled

Abstract Fatigue is common after stroke and contributes to disability and impaired quality of life. Currently, there is insufficient evidence on the efficacy of any intervention for post-stroke fatigue. The aim of the study was to examine whether 10 weeks Nature-based rehabilitation (NRB) as add-on to standard care may improve post-stroke fatigue, perceived value of everyday occupations, function, activity and participation compared to standard care only (Clinical Trial.gov Identifier: NCT02435043, 2012/352, 05-06-2015). The study was carried out as a single blinded two-armed randomised controlled trial. Stroke survivors identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke > 1 year earlier) were randomised to Standard care + NBR or Standard care only. Blinded evaluations were conducted at follow-up 8 and 14 months after randomisation. The primary outcomes were post-stroke fatigue (Mental Fatigue Scale, total score) and perceived value of everyday occupations (Oval-pd) 8 months after randomisation. About a quarter of the screened patients were eligible; half accepted to participate and 101 were randomised, mean age 67 years, 60% female. The patients with sub-acute stroke were highly compliant with the intervention. Fatigue decreased to a value below the suggested cut-off for mental fatigue (<10.5) in the intervention group but not in the control group; no statistically significant differences were found though between the groups. Conclusion: NASTRU is the first randomised study on NBR for patients with post stroke fatigue. NBR was feasible and well tolerated. The study was underpowered due to difficulties in recruiting participants. No significant differences were detected between intervention and control group. A larger RCT is warranted. Keywords: clinical trial, enriched environment, everyday occupations, horticulture therapy, quality of life.

Download Full-text