Postcards from the EDge: 24-month outcomes of a randomised controlled trial for hospital-treated self-poisoning

BackgroundRepetition of self-poisoning is common.AimsTo report the 24-month outcomes of a non-obligatory postcard intervention (plus treatment as usual) compared with treatment as usual.MethodIn a randomised-controlled trial (Zelen design) conducted in Newcastle, Australia, eight postcards were sent to participants over a 12-month period. The principal outcomes were the proportion of participants with one or more repeat episodes of self-poisoning and the number of repeat episodes per person.ResultsNo significant reduction was observed in the proportion of people repeating self-poisoning in the intervention group (21.2%, 95% CI 17.0–25.3) compared with the control group (22.8%, 95% CI 18.7–27.0;χ2=0.32, d.f. = 1,P= 0.57); the difference between groups was −1.7% (95% CI −7.5 to 4.2). There was a significant reduction in the rate of repetition, with an incidence risk ratio of 0.49 (95% CI 0.33–0.73).ConclusionsA postcard intervention maintained the halving of the rate of repetition of hospital-treated self-poisoning events over a 2-year period, although it did not significantly reduce the proportion of individuals who repeated self-poisoning.

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Postcards from the EDge: 5-year outcomes of a randomised controlled trial for hospital-treated self-poisoning

The British Journal of Psychiatry ◽

10.1192/bjp.bp.112.112664 ◽

2013 ◽

Vol 202 (5) ◽

pp. 372-380 ◽

Cited By ~ 50

Author(s):

Gregory L. Carter ◽

Kerrie Clover ◽

Ian M. Whyte ◽

Andrew H. Dawson ◽

Catherine D'Este

Keyword(s):

Randomised Controlled Trial ◽

Psychiatric Hospital ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Treatment As Usual ◽

Psychiatric Admissions ◽

Bed Days ◽

Randomised Controlled ◽

Event Rates

BackgroundRepetition of hospital-treated self-poisoning and admission to psychiatric hospital are both common in individuals who self-poison.AimsTo evaluate efficacy of postcard intervention after 5 years.MethodA randomised controlled trial of individuals who have self-poisoned: postcard intervention (eight in 12 months) plus treatment as usualv.treatment as usual. Our primary outcomes were self-poisoning admissions and psychiatric admissions (proportions and event rates).ResultsThere was no difference between groups for any repeat-episode self-poisoning admission (intervention group: 24.9%, 95% CI 20.6-29.5; control group: 27.2%, 95% CI 22.8-31.8) but there was a significant reduction in event rates (incidence risk ratio (IRR)=0.54, 95% CI 0.37-0.81), saving 306 bed days. There was no difference for any psychiatric admission (intervention group: 38.1%, 95% CI 33.1-43.2; control group: 35.5%, 95% CI 30.8-40.5) but there was a significant reduction in event rates (IRR=0.66, 95% CI 0.47-0.91), saving 2565 bed days.ConclusionsA postcard intervention halved self-poisoning events and reduced psychiatric admissions by a third after 5 years. Substantial savings occurred in general hospital and psychiatric hospital bed days.

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Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study

BMJ Open ◽

10.1136/bmjopen-2019-033842 ◽

2020 ◽

Vol 10 (5) ◽

pp. e033842 ◽

Cited By ~ 1

Author(s):

Xiaochang Zhang ◽

Xiao Hu ◽

Jixiang Ma ◽

Puhong Zhang ◽

Yuan Li ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Salt Intake ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Cluster Randomised ◽

The Difference ◽

Randomised Controlled

IntroductionSalt intake in China is twice the upper limit recommended by the WHO, and nearly 80% of salt is added during cooking. This study will develop a package of salt reduction interventions targeting home cooks and evaluate its effectiveness and feasibility for scale-up.Methods and analysisA cluster randomised controlled trial design is adopted in this study, which will be conducted in six provinces covering northern, central and southern China. For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member) will be selected in each cluster for evaluation. In total, 780 home cooks and 780 adult family members will be recruited. The home cooks in the intervention group will be provided with the intervention package, including community-based standardised offline and online health education and salt intake monitoring. The duration of the intervention will be 1 year. The primary outcome is the difference between the intervention and control group in change in salt intake as measured by 24 hours urinary sodium from baseline to the end of the trial. The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).Ethics and disseminationThe study has been approved by The Queen Mary Research Ethics Committee (QMERC2018/13) and Institutional Review Board of the Chinese Center for Disease Control and Prevention (No. 201801). The study findings will be disseminated widely through conference presentations and peer-reviewed publications and the general media.Trial registration numberChiCTR1800016804.

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Effects of training on quality of peer review: randomised controlled trial

BMJ ◽

10.1136/bmj.38023.700775.ae ◽

2004 ◽

Vol 328 (7441) ◽

pp. 673 ◽

Cited By ~ 112

Author(s):

Sara Schroter ◽

Nick Black ◽

Stephen Evans ◽

James Carpenter ◽

Fiona Godlee ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Peer Review ◽

Controlled Trial ◽

Control Group ◽

Group Score ◽

The Difference ◽

Randomised Controlled ◽

Quality Instrument

AbstractObjective To determine the effects of training on the quality of peer review.Design Single blind randomised controlled trial with two intervention groups receiving different types of training plus a control group.Setting and participants Reviewers at a general medical journal.Interventions Attendance at a training workshop or reception of a self taught training package focusing on what editors want from reviewers and how to critically appraise randomised controlled trials.Main outcome measures Quality of reviews of three manuscripts sent to reviewers at four to six monthly intervals, evaluated using the validated review quality instrument; number of deliberate major errors identified; time taken to review the manuscripts; proportion recommending rejection of the manuscripts.Results Reviewers in the self taught group scored higher in review quality after training than did the control group (score 2.85 v 2.56; difference 0.29, 95% confidence interval 0.14 to 0.44; P = 0.001), but the difference was not of editorial significance and was not maintained in the long term. Both intervention groups identified significantly more major errors after training than did the control group (3.14 and 2.96 v 2.13; P < 0.001), and this remained significant after the reviewers' performance at baseline assessment was taken into account. The evidence for benefit of training was no longer apparent on further testing six months after the interventions. Training had no impact on the time taken to review the papers but was associated with an increased likelihood of recommending rejection (92% and 84% v 76%; P = 0.002).Conclusions Short training packages have only a slight impact on the quality of peer review. The value of longer interventions needs to be assessed.

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Multicentre, randomised controlled trial of PDSAFE, a physiotherapist-delivered fall prevention programme for people with Parkinson’s

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2018-319448 ◽

2019 ◽

Vol 90 (7) ◽

pp. 774-782 ◽

Cited By ~ 15

Author(s):

Kim Chivers Seymour ◽

Ruth Pickering ◽

Lynn Rochester ◽

Helen C Roberts ◽

Claire Ballinger ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Fall Prevention ◽

Controlled Trial ◽

Intervention Group ◽

Prevention Programme ◽

Control Group ◽

Chair Stand ◽

Subgroup Analyses ◽

Randomised Controlled ◽

Fall Prevention Programme

ObjectiveTo estimate the effect of a physiotherapist-delivered fall prevention programme for people with Parkinson’s (PwP).MethodsPeople at risk of falls with confirmed Parkinson’s were recruited to this multicentre, pragmatic, investigator blind, individually randomised controlled trial with prespecified subgroup analyses. 474 PwP (Hoehn and Yahr 1–4) were randomised: 238 allocated to a physiotherapy programme and 236 to control. All participants had routine care; the control group received a DVD about Parkinson’s and single advice session at trial completion. The intervention group (PDSAFE) had an individually tailored, progressive home-based fall avoidance strategy training programme with balance and strengthening exercises. The primary outcome was risk of repeat falling, collected by self-report monthly diaries, 0–6 months after randomisation. Secondary outcomes included Mini-BESTest for balance, chair stand test, falls efficacy, freezing of gait, health-related quality of life (EuroQol EQ-5D), Geriatric Depression Scale, Physical Activity Scale for the Elderly and Parkinson’s Disease Questionnaire, fractures and rate of near falling.ResultsAverage age is 72 years and 266 (56%) were men. By 6 months, 116 (55%) of the control group and 125 (61.5%) of the intervention group reported repeat falls (controlled OR 1.21, 95% CI 0.74 to 1.98, p=0.447). Secondary subgroup analyses suggested a different response to the intervention between moderate and severe disease severity groups. Balance, falls efficacy and chair stand time improved with near falls reduced in the intervention arm.ConclusionPDSAFE did not reduce falling in this pragmatic trial of PwP. Other functional tasks improved and reduced fall rates were apparent among those with moderate disease.Trial registration numberISRCTN48152791.

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Efficacy of a smartphone-based coaching program for addiction prevention among apprentices: study protocol of a cluster-randomised controlled trial

BMC Public Health ◽

10.1186/s12889-020-09995-6 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Severin Haug ◽

Raquel Paz Castro ◽

Andreas Wenger ◽

Michael P. Schaub

Keyword(s):

Randomised Controlled Trial ◽

Cigarette Smoking ◽

Internet Use ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Addiction Prevention ◽

Cluster Randomised ◽

Randomised Controlled

Abstract Background A large proportion of apprentices shows addictive behaviours like cigarette smoking, alcohol, cannabis, or compulsive Internet use, others do not show such behaviours at all. ready4life is a smartphone application-based coaching program for apprentices, which takes into account the heterogeneity of adolescent addictive behaviour by promoting life skills and reducing risk behaviours. The main objective of the planned study is to test the efficacy of ready4life for addiction prevention among apprentices in Switzerland within a controlled trial. Methods/design The efficacy of the ready4life coaching program will be tested in comparison to an assessment only control group, within a cluster-randomised controlled trial with one follow-up assessment after 6 months. At the beginning of the program, participants of the intervention group will receive an individual profile, showing areas in which they have sufficient resources and in which there is a need for coaching. Based on this feedback, they can select two out of the following six program modules: stress, social skills, Internet use, tobacco/e-cigarettes, cannabis, and alcohol. Participants of the intervention group will receive individualised coaching by a conversational agent (chatbot) for a period of four months. The coaching relies on motivational and social-cognitive principles of behaviour change. Within weekly dialogues, the coach provides individually tailored information in different formats, such as videoclips, texts, or pictures. Study participants will be 1318 apprentices with a minimum age of 15, recruited in approximately 100 vocational school classes in Switzerland. Primary outcome will be a composite measure for addictive behaviours including (1) at risk-drinking, (2) tobacco/e-cigarette smoking, (3) cannabis use, and (4) problematic Internet use. Discussion The study will reveal whether this universally implementable but individually tailored intervention approach is effective in preventing the onset and escalation of addictive behaviors among apprentices. Trial registration ISRCTN59908406 (registration date: 21/10/2020).

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Assessment of the Effectiveness of a Computerised Decision-Support Tool for Health Professionals for the Prevention and Treatment of Childhood Obesity. Results from a Randomised Controlled Trial

Nutrients ◽

10.3390/nu11030706 ◽

2019 ◽

Vol 11 (3) ◽

pp. 706 ◽

Cited By ~ 4

Author(s):

George Moschonis ◽

Maria Michalopoulou ◽

Konstantina Tsoutsoulopoulou ◽

Elpis Vlachopapadopoulou ◽

Stefanos Michalacos ◽

...

Keyword(s):

Decision Support ◽

Childhood Obesity ◽

Randomised Controlled Trial ◽

Healthcare Professionals ◽

Controlled Trial ◽

Intervention Group ◽

Decision Support Tool ◽

Control Group ◽

Support Tool ◽

Randomised Controlled

We examined the effectiveness of a computerised decision-support tool (DST), designed for paediatric healthcare professionals, as a means to tackle childhood obesity. A randomised controlled trial was conducted with 65 families of 6–12-year old overweight or obese children. Paediatricians, paediatric endocrinologists and a dietitian in two children’s hospitals implemented the intervention. The intervention group (IG) received personalised meal plans and lifestyle optimisation recommendations via the DST, while families in the control group (CG) received general recommendations. After three months of intervention, the IG had a significant change in dietary fibre and sucrose intake by 4.1 and −4.6 g/day, respectively. In addition, the IG significantly reduced consumption of sweets (i.e., chocolates and cakes) and salty snacks (i.e., potato chips) by −0.1 and −0.3 portions/day, respectively. Furthermore, the CG had a significant increase of body weight and waist circumference by 1.4 kg and 2.1 cm, respectively, while Body Mass Index (BMI) decreased only in the IG by −0.4 kg/m2. However, the aforementioned findings did not differ significantly between study groups. In conclusion, these findings indicate the dynamics of the DST in supporting paediatric healthcare professionals to improve the effectiveness of care in modifying obesity-related behaviours. Further research is needed to confirm these findings.

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Effects of a kindergarten intervention on vegetables served and staff’s food-related practices: results of a cluster randomised controlled trial – the BRA study

Public Health Nutrition ◽

10.1017/s1368980019003963 ◽

2020 ◽

Vol 23 (6) ◽

pp. 1117-1126

Author(s):

Anne Himberg-Sundet ◽

Anne Lene Kristiansen ◽

Lene Frost Andersen ◽

Mona Bjelland ◽

Nanna Lien

Keyword(s):

Randomised Controlled Trial ◽

Vegetable Intake ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Public And Private ◽

Cluster Randomised ◽

Block Randomisation ◽

Randomised Controlled

AbstractObjective:The aim of the current study was to evaluate the effect on frequency, variety and amount of vegetables served and staff’s food-related practices in the multicomponent BRA intervention.Design:Cluster randomised controlled trial, conducted between Spring 2015 and Spring 2016. For allocation of the kindergartens, a stratified block randomisation was used. Data were collected in three ways: (i) a questionnaire for pedagogical leaders assessing the variety and frequency of vegetables served, including staff’s food-related practices assumed to be related to vegetable intake; (ii) a questionnaire for kindergarten assistants assessing staff’s food-related practices; (iii) a 5-d weighted vegetable diary assessing amount of vegetables served in a department.Setting:The target group for this study was public and private kindergartens in the counties of Vestfold and Buskerud, Norway.Participants:A total of seventy-three kindergartens participated.Results:At follow-up I, the amount of vegetables served increased by approximately 20 g per person per day (P = 0·002), and the variety in served vegetables increased by one-and-a-half kind per month (P = 0·014) in the intervention group compared to the control group. No effects on the frequency of vegetables served or on staff’s food-related practices were found.Conclusions:The BRA intervention was successful in increasing the amount and variety of vegetables served within intervention kindergartens. Further research is needed to understand the mechanisms that can affect the staff’s food-related practices.

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Effectiveness of online tailored advice to prevent running-related injuries and promote preventive behaviour in Dutch trail runners: a pragmatic randomised controlled trial

British Journal of Sports Medicine ◽

10.1136/bjsports-2016-097025 ◽

2017 ◽

Vol 52 (13) ◽

pp. 851-858 ◽

Cited By ~ 13

Author(s):

Luiz Carlos Hespanhol ◽

Willem van Mechelen ◽

Evert Verhagen

Keyword(s):

Randomised Controlled Trial ◽

Preventive Intervention ◽

Absolute Risk ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Number Needed To Treat ◽

Preventive Behaviour ◽

Randomised Controlled ◽

Tailored Advice

BackgroundTrail running is popular worldwide, but there is no preventive intervention for running-related injury (RRI).AimTo evaluate the effectiveness of adding online tailored advice (TrailS6) to general advice on (1) the prevention of RRIs and (2) the determinants and actual preventive behaviour in Dutch trail runners.MethodsTwo-arm randomised controlled trial over 6 months. 232 trail runners were randomly assigned to an intervention or control group. All participants received online general advice on RRI prevention 1 week after baseline. Every 2 weeks, participants in the intervention group received specific advice tailored to their RRI status. The control group received no further intervention. Bayesian mixed models were used to analyse the data.ResultsTrail runners in the intervention group sustained 13% fewer RRIs compared with those in the control group after 6 months of follow-up (absolute risk difference −13.1%, 95% Bayesian highest posterior credible interval (95% BCI) −23.3 to −3.1). A preventive benefit was observed in one out of eight trail runners who had received the online tailored advice for 6 months (number needed to treat 8, 95% BCI 3 to 22). No significant between-group difference was observed on the determinants and actual preventive behaviours.ConclusionsOnline tailored advice prevented RRIs among Dutch trail runners. Therefore, online tailored advice may be used as a preventive component in multicomponent RRI prevention programmes. No effect was observed on determinants and actual preventive behaviours.Trial registration numberThe Netherlands National Trial Register (NTR5431).

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User-driven design of child restraint information to reduce errors in use: a pilot randomised controlled trial

Injury Prevention ◽

10.1136/injuryprev-2019-043380 ◽

2019 ◽

Vol 26 (5) ◽

pp. 432-438 ◽

Cited By ~ 2

Author(s):

Alexandra B Hall ◽

Catherine Ho ◽

Bianca Albanese ◽

Lisa Keay ◽

Kate Hunter ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Instructional Materials ◽

Control Group ◽

P Value ◽

Point Increase ◽

Comprehension Score ◽

Child Restraint ◽

Randomised Controlled

BackgroundIncorrect use of child restraints is a long-standing problem that increases the risk of injury in crashes. We used user-centred design to develop prototype child restraint instructional materials. The objective of this study was to evaluate these materials in terms of comprehension and errors in the use of child restraints. The relationship between comprehension and errors in use was also explored.MethodsWe used a parallel-group randomised controlled trial in a laboratory setting. The intervention group (n=22) were provided with prototype materials and the control group (n=22) with existing instructional materials for the same restraint. Participants installed the restraint in a vehicle buck, secured an appropriately sized mannequin in the restraint and underwent a comprehension test. Our primary outcome was overall correct use, and our secondary outcomes were (1) comprehension score and (2) percent errors in the installation trial.ResultsThere was 27% more overall correct use (p=0.042) and a higher mean comprehension score in the intervention group (mean 17, 95% CI 16 to 18) compared with the control group (mean 12, 95% CI 10 to 14, p<0.001). The mean error percentage in the control group was 23% (95% CI 16% to 31%) compared with 14% in the intervention group (95% CI 8% to 20%, p=0.056). For every one point increase in comprehension, there was an almost 2% (95% CI −2.7% to −1.0%) reduction in errors (y=45.5–1.87x, p value for slope <0.001).ConclusionsConsumer-driven design of informational materials can increase the correct use of child restraints. Targeting improved comprehension of informational materials may be an effective mechanism for reducing child restraint misuse.

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86 Developing the Adapted Lifestyle - Integrated Functional Exercise Programme in Thai Context (TLIFE) to Prevent Falls among Older Adults in Thailand: A Mixed Methods Study

Age and Ageing ◽

10.1093/ageing/afz164.86 ◽

2019 ◽

Vol 48 (Supplement_4) ◽

pp. iv18-iv27

Author(s):

Sasiporn Ounjaichon ◽

Chris Todd ◽

Emma Stanmore ◽

Elisabeth Boulton

Keyword(s):

Older Adults ◽

Randomised Controlled Trial ◽

Retention Rate ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Programme ◽

Community Dwelling ◽

Control Group ◽

Functional Exercise ◽

Randomised Controlled

Abstract Introduction Falls are the leading cause of injuries in older Thai adults. There is a need to develop a fall prevention exercise programme to encourage participation and adherence. The adapted Lifestyle-integrated Functional Exercise (aLiFE) programme may be suitable by integrating exercise into daily routines as opposed to attending an exercise class. This study aimed to explore the acceptability and feasibility of the aLiFE programme in Thai context (TLiFE) among older Thai adults. Methods Based on the findings of a prior qualitative study, a feasibility randomised controlled trial (RCT) of TLiFE was conducted among community-dwelling older adults, comparing the TLiFE intervention group with a usual care control group. Outcome measures were analysed at baseline, 3 months, and after 6 months of the intervention. Results We recruited a total of 72 older adults into the RCT, randomised to TLiFE (n=36) and control (n=36). The retention rate at 6 months was 91.7%. Attendance in the intervention group (3 home visits and 4 follow-up calls) was 82.9%. There were no differences in fall incidence between the groups. The acceptability survey reveals TLiFE is easy to perform in daily life, safe, and useful. No adverse events were reported. Conclusion The TLiFE programme appears to be acceptable and feasible to deliver to community-dwelling older Thai adults. This feasibility study was not powered to detect a difference between groups. A further fully powered definitive randomised controlled trial of TLiFE is needed to evaluate long-term outcomes and cost-effectiveness before it is integrated within the healthcare system in Thailand.

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