Parental consent to participation in a randomised trial in children: Associated child, family, and physician factors

2012 ◽  
Vol 9 (5) ◽  
pp. 645-651 ◽  
Author(s):  
Premala Sureshkumar ◽  
Patrina Caldwell ◽  
Alison Lowe ◽  
Judy M Simpson ◽  
Gabrielle Williams ◽  
...  
Keyword(s):  
Statistical Power ◽  
Research Study ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Vesicoureteric Reflux ◽  
Trial Participation ◽  
Team Approach ◽  
Parental Consent ◽  
Study Team ◽  
Randomised Controlled

Background Low participation rates in randomised controlled trials involving children are almost a universal problem, leading to high cost and low statistical power. Trial, parent/family, child, and physician factors have been reported to influence parental willingness to consent for paediatric trials. Purpose To identify modifiable and unmodifiable factors associated with parental consent. Methods Demographic and clinical characteristics of children and their families and physician characteristics associated with parental consent were evaluated in a recent randomised placebo-controlled trial of prophylactic antibiotics to prevent recurrent urinary tract infection. Results Of 1109 eligible children identified (mean age, 2.0 years), 412 parents (37.2%) consented. On a multivariate analysis, the only modifiable factor associated with consent was request for consent by a member of the research study team rather than by a member of the clinical team (risk ratio (RR) = 1.9, 95% confidence interval (CI): 1.2–2.9). The unmodifiable factors significantly associated with consent were age of the child (≥4 years) (RR = 1.2, 95% CI: 1.1–1.4), presence of vesicoureteric reflux (RR = 1.5, 95% CI: 1.3–1.8), inpatient management of the index infection (RR = 0.8, 95% CI: 0.7–0.9), and multiple (≥4) symptoms at presentation (RR = 1.3, 95% CI: 1.1–1.5). Limitations We have reported data from only one of the four participating centres in this trial. Data on non-consenters in other participating centres were not completely collected. Data on characteristics of the recruiting physician were limited. These findings are applicable for those considering a single randomised controlled trial. Conclusions Parent, child, and physician factors are associated with consent for trial participation, with most not being modifiable. Having a member of the research study team approach the parent for consent appears to be the only feasible strategy for increasing recruitment to randomised trials in this setting.

scholarly journals A Police Partnership Targeting Truancy: Study Protocol for a Cluster Randomised Controlled Trial

2020 ◽  
Vol 4 (3-4) ◽  
pp. 134-159
Author(s):  
Lorraine Mazerolle ◽  
Sarah Bennett ◽  
Stephanie M. Cardwell
Keyword(s):  
School Engagement ◽  
Statistical Power ◽  
School Attendance ◽  
Controlled Trial ◽  
Research Question ◽  
Randomised Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Research Question How can an Australian police agency best test its role in a truancy prevention programme that can help to prevent crime? Data Operational and analytic planning for testing the Ability School Engagement Partnership (ASEP) programme in Queensland that aims to increase school attendance and reduce anti-social behaviour, including offending. Methods Fulfilling the requirements for registering a randomised trial protocol with the Clinicaltrials.gov Registry (NCT04281966; date registered 24 February 2020). Findings A protocol deploying a cluster randomised trial offers sufficient statistical power to detect a moderately large effect size as statistically significant with 80% probability. Conclusion Implementation of this protocol as planned would provide an internally valid test of the effectiveness of the ASEP programme in real-world conditions.

scholarly journals Web-based early intervention for children with motor difficulties aged 3–8 years old using multimodal rehabilitation (WECARE): protocol of a patient-centred pragmatic randomised trial of paediatric telerehabilitation to support families

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e046561
Author(s):  
Chantal Camden ◽  
Jill G Zwicker ◽  
Melanie Morin ◽  
Tibor Schuster ◽  
Melanie Couture ◽  
...  
Keyword(s):  
Early Intervention ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Parental Knowledge ◽  
Performance Measure ◽  
Performance Goals ◽  
Web Based ◽  
Study Results ◽  
Motor Difficulties ◽  
Randomised Controlled

IntroductionMild motor difficulties in children are underdiagnosed despite being highly prevalent, leaving such children often underserved and at higher risk for secondary consequences such as cardiovascular disease and anxiety. Evidence suggests that early patient-oriented interventions, coaching parents and providing children with early stimulation should be provided, even in the absence of a diagnosis. Such interventions may be effectively delivered via telerehabilitation.Methods and analysisA family-centred, pragmatic randomised controlled trial will be carried out to evaluate the real-world effectiveness of a Web-based Early intervention for Children using multimodAl REhabilitation (WECARE). Families of children with motor difficulties, 3–8 years of age, living in Quebec, Canada, and receiving no public rehabilitation services (n=118) will be asked to determine up to 12 performance goals, evaluated using the Canadian Occupational Performance Measure (COPM, the primary outcome). Families will be randomised to receive either usual care or the WECARE intervention. The WECARE intervention will be delivered for 1 year via a web-based platform. Families will have access to videoconferences with an assigned rehabilitation therapist using a collaborative coaching approach, a private chat function, a forum open to all intervention arm participants and online resources pertaining to child development. Participants will be asked to re-evaluate the child’s COPM performance goals every 3 months up to 1 year post allocation. The COPM results will be analysed using a mixed Poisson regression model. Secondary outcomes include measures of the child’s functional ability, parental knowledge and skills and health-related quality of life, as well as qualitative outcomes pertaining to parental satisfaction and service delivery trajectories. Investigators and quantitative data analysts will be blinded to group allocation.Ethics and disseminationThe CIUSSS de l’Estrie—CHUS ethics committee approved this trial (2020-3429). Study results will be communicated via peer-reviewed journal publications, conference presentations and stakeholder-specific knowledge transfer activities.Trial registration numberNCT04254302.

scholarly journals The effect of sertraline on emotional processing: secondary analyses of the PANDA randomised controlled trial

2021 ◽  
pp. 1-8
Author(s):  
Norin Ahmed ◽  
Jessica K. Bone ◽  
Gemma Lewis ◽  
Nick Freemantle ◽  
Catherine J. Harmer ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Emotional Processing ◽  
Statistical Power ◽  
Controlled Trial ◽  
Negative Information ◽  
Small Samples ◽  
Double Blind ◽  
Treatment Allocation ◽  
Randomised Controlled ◽  
Cognitive Neuropsychological

Abstract Background According to the cognitive neuropsychological model, antidepressants reduce symptoms of depression and anxiety by increasing positive relative to negative information processing. Most studies of whether antidepressants alter emotional processing use small samples of healthy individuals, which lead to low statistical power and selection bias and are difficult to generalise to clinical practice. We tested whether the selective serotonin reuptake inhibitor (SSRI) sertraline altered recall of positive and negative information in a large randomised controlled trial (RCT) of patients with depressive symptoms recruited from primary care. Methods The PANDA trial was a pragmatic multicentre double-blind RCT comparing sertraline with placebo. Memory for personality descriptors was tested at baseline and 2 and 6 weeks after randomisation using a computerised emotional categorisation task followed by a free recall. We measured the number of positive and negative words correctly recalled (hits). Poisson mixed models were used to analyse longitudinal associations between treatment allocation and hits. Results A total of 576 participants (88% of those randomised) completed the recall task at 2 and 6 weeks. We found no evidence that positive or negative hits differed according to treatment allocation at 2 or 6 weeks (adjusted positive hits ratio = 0.97, 95% CI 0.90–1.05, p = 0.52; adjusted negative hits ratio = 0.99, 95% CI 0.90–1.08, p = 0.76). Conclusions In the largest individual placebo-controlled trial of an antidepressant not funded by the pharmaceutical industry, we found no evidence that sertraline altered positive or negative recall early in treatment. These findings challenge some assumptions of the cognitive neuropsychological model of antidepressant action.

scholarly journals Methods for delivering the UK's multi-centre prison-based naloxone-on-release pilot randomised trial (N-ALIVE): Europe's largest prison-based randomised controlled trial

2017 ◽  
Vol 37 (4) ◽  
pp. 487-498 ◽  
Author(s):  
Angela Mary Meade ◽  
Sheila Macdonald Bird ◽  
John Strang ◽  
Tracey Pepple ◽  
Laura Lea Nichols ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Randomised Controlled

scholarly journals MAGDALENA: study protocol of a randomised, placebo-controlled trial on cognitive development at 2 years of age in children exposed to SSRI in utero

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e023281 ◽  
Author(s):  
Essi Heinonen ◽  
Barbara Szymanska-von Schultz ◽  
Viktor Kaldo ◽  
Josefine Nasiell ◽  
Ewa Andersson ◽  
...  
Keyword(s):  
Cognitive Development ◽  
Pregnant Women ◽  
Maternal Depression ◽  
Statistical Power ◽  
Controlled Trial ◽  
Randomised Trial ◽  
In Utero ◽  
Primary Objective ◽  
Ethical Review ◽  
Moderate Depression

IntroductionTen per cent of all pregnant women are depressed. Standard therapy of pregnant women with moderate depression is selective serotonin reuptakeinhibitors (SSRI). Observational studies on neurodevelopment after fetal SSRI exposure show conflicting results. Our primary objective is to compare the cognitive development in children exposed to sertraline and maternal depression with those exposed to maternal depression and placebo in utero. We hypothesise that there is a significant neurodevelopmental difference between the groups. As a secondary objective, we study the add-on effect of sertraline to internet-based cognitive behavioural therapy (ICBT) to treat moderate depression during pregnancy.Methods and analysisMAGDALENA is a randomised, placebo-controlled, double-blinded trial in Stockholm Healthcare Region with 2.3 million inhabitants. The women are recruited in weeks 9–21 of pregnancy either through Antenatal Health Clinics or through social media. They are to be diagnosed with moderate depression without ongoing antidepressive therapy or any serious comorbidity. The women in the intervention arm receive sertraline combined with a 12-week period of ICBT; the control arm is treated with placebo and ICBT. We assess the cognitive development in the offspring at the age of 2 years using Bayley Scales of Infant and Toddler Development, third edition (BSID-III). We aim at recruiting 200 women, 100 women in each treatment arm, to ensure statistical power to detect a clinically relevant difference between the groups.Ethics and disseminationThis randomised trial will provide long-sought evidence about the effects of SSRI and maternal depression during pregnancy on the neurodevelopment in the offspring. The study is approved by the Regional Ethical Review Board at Karolinska Institutet in Stockholm and the Swedish Medical Products Agency. It is registered with the European Clinical Trials Database (EudraCT), Number: 2013-004444-31. Results will be disseminated at scientific conferences, published in peer-reviewed journals and made available to the public.Trial registration numberEudraCT2013-004444-31; Pre-results.

scholarly journals Cognitive tests used in chronic adult human randomised controlled trial micronutrient and phytochemical intervention studies

2010 ◽  
Vol 23 (2) ◽  
pp. 200-229 ◽  
Author(s):  
Anna L. Macready ◽  
Laurie T. Butler ◽  
Orla B. Kennedy ◽  
Judi A. Ellis ◽  
Claire M. Williams ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Statistical Power ◽  
Type I Error ◽  
Spatial Working Memory ◽  
Controlled Trial ◽  
Type I ◽  
Cognitive Tests ◽  
Cognitive Domains ◽  
Positive Effects ◽  
Randomised Controlled

In recent years there has been a rapid growth of interest in exploring the relationship between nutritional therapies and the maintenance of cognitive function in adulthood. Emerging evidence reveals an increasingly complex picture with respect to the benefits of various food constituents on learning, memory and psychomotor function in adults. However, to date, there has been little consensus in human studies on the range of cognitive domains to be tested or the particular tests to be employed. To illustrate the potential difficulties that this poses, we conducted a systematic review of existing human adult randomised controlled trial (RCT) studies that have investigated the effects of 24 d to 36 months of supplementation with flavonoids and micronutrients on cognitive performance. There were thirty-nine studies employing a total of 121 different cognitive tasks that met the criteria for inclusion. Results showed that less than half of these studies reported positive effects of treatment, with some important cognitive domains either under-represented or not explored at all. Although there was some evidence of sensitivity to nutritional supplementation in a number of domains (for example, executive function, spatial working memory), interpretation is currently difficult given the prevailing ‘scattergun approach’ for selecting cognitive tests. Specifically, the practice means that it is often difficult to distinguish between a boundary condition for a particular nutrient and a lack of task sensitivity. We argue that for significant future progress to be made, researchers need to pay much closer attention to existing human RCT and animal data, as well as to more basic issues surrounding task sensitivity, statistical power and type I error.

scholarly journals Drooling Reduction Intervention randomised trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability

2017 ◽  
Vol 103 (4) ◽  
pp. 371-376 ◽  
Author(s):  
Jeremy R Parr ◽  
Emma Todhunter ◽  
Lindsay Pennington ◽  
Deborah Stocken ◽  
Jill Cadwgan ◽  
...  
Keyword(s):  
Side Effects ◽  
Controlled Trial ◽  
Symptom Control ◽  
Randomised Trial ◽  
Frequency Scale ◽  
Skin Patch ◽  
Impact Scale ◽  
Significant Difference ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveInvestigate whether hyoscine patch or glycopyrronium liquid is more effective and acceptable to treat drooling in children with neurodisability.DesignMulticentre, single-blind, randomised controlled trial.SettingRecruitment through neurodisability teams; treatment by parents.ParticipantsNinety children with neurodisability who had never received medication for drooling (55 boys, 35 girls; median age 4 years). Exclusion criteria: medication contraindicated; in a trial that could affect drooling or management.InterventionChildren were randomised to receive a hyoscine skin patch or glycopyrronium liquid. Dose was increased over 4 weeks to achieve optimum symptom control with minimal side-effects; steady dose then continued to 12 weeks.Primary and secondary outcomesPrimary outcome: Drooling Impact Scale (DIS) score at week-4. Secondary outcomes: change in DIS scores over 12 weeks, Drooling Severity and Frequency Scale and Treatment Satisfaction Questionnaire for Medication; adverse events; children’s perception about treatment.ResultsBoth medications yielded clinically and statistically significant reductions in mean DIS at week-4 (25.0 (SD 22.2) for hyoscine and 26.6 (SD 16) for glycopyrronium). There was no significant difference in change in DIS scores between treatment groups. By week-12, 26/47 (55%) children starting treatment were receiving hyoscine compared with 31/38 (82%) on glycopyrronium. There was a 42% increased chance of being on treatment at week-12 for children randomised to glycopyrronium relative to hyoscine (1.42, 95% CI 1.04 to 1.95).ConclusionsHyoscine and glycopyrronium are clinically effective in treating drooling in children with neurodisability. Hyoscine produced more problematic side effects leading to a greater chance of treatment cessation.Trial registration numbersISRCTN75287237; EUDRACT: 2013-000863-94; Medicines and Healthcare Products Regulatory Agency: 17136/0264/001-0003

scholarly journals Effects of injectable progestogen contraception versus the copper intrauterine device on HIV acquisition: sub-study of a pragmatic randomised controlled trial

2017 ◽  
Vol 43 (3) ◽  
pp. 175-180 ◽  
Author(s):  
G Justus Hofmeyr ◽  
Mandisa Singata-Madliki ◽  
Theresa A Lawrie ◽  
Eduardo Bergel ◽  
Marleen Temmerman
Keyword(s):  
Randomised Controlled Trial ◽  
South African ◽  
Pregnancy Termination ◽  
Controlled Trial ◽  
Intrauterine Device ◽  
Randomised Trial ◽  
Contraceptive Device ◽  
Increased Risk ◽  
Hiv Acquisition ◽  
Randomised Controlled

BackgroundEvidence from observational studies suggests an increased risk of HIV acquisition among women using depot medroxyprogesterone acetate (DMPA) contraception.MethodsWithin the context of a South African programme to increase women's access to the intrauterine contraceptive device (IUD), we conducted a pragmatic, open-label, parallel-arm, randomised controlled trial (RCT) of the IUD versus injectable progestogen contraception (IPC) at two South African hospitals. The primary outcome was pregnancy; secondary outcomes included HIV acquisition. Consenting women attending termination of pregnancy services were randomised after pregnancy termination between July 2009 and November 2012. Condoms were promoted for the prevention of sexually transmitted infections. Voluntary HIV testing was offered at baseline and at 12 or more months later. Findings on HIV acquisition are reported in this article.ResultsHIV acquisition data were available for 1290 initially HIV-negative women who underwent a final study interview at a median of 20 months after randomisation to IPC or an IUD. Baseline group characteristics were comparable. In the IPC group, 545/656 (83%) of participants received DMPA, 96 (15%) received injectable norethisterone enanthate, 14 (2%) received the IUD and one received oral contraception. In the IUD group 609 (96%) received the IUD, 20 (3%) received IPC and 5 (1%) had missing data. According to intention-to-treat analysis, HIV acquisition occurred in 20/656 (3.0%) women in the IPC arm and 22/634 (3.5%) women in the IUD arm (IPC vs IUD, risk ratio 0.88; 95% confidence interval 0.48–1.59;p=0.7).ConclusionsThis sub-study was underpowered to rule out moderate differences in HIV risk, but confirms the feasibility of randomised trial methodology to address this question. Larger RCTs are needed to determine the relative risks of various contraceptive methods on HIV acquisition with greater precision.Trial registration numberPan African Clinical Trials Registry number PACTR201409000880157 (04-09-2014).

scholarly journals Longitudinal Study of music Therapy’s Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e025062 ◽  
Author(s):  
Claire Ghetti ◽  
Łucja Bieleninik ◽  
Mari Hysing ◽  
Ingrid Kvestad ◽  
Jörg Assmus ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Infant Development ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Developmentally Appropriate ◽  
Well Being ◽  
Positive Effects ◽  
Implementation And Dissemination ◽  
Randomised Controlled

IntroductionPreterm birth has major medical, psychological and socioeconomic consequences worldwide. Music therapy (MT) has positive effects on physiological measures of preterm infants and maternal anxiety, but rigorous studies including long-term follow-up are missing. Drawing on caregivers’ inherent resources, this study emphasises caregiver involvement in MT to promote attuned, developmentally appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalisation and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.Methods and analysisDesign:international multicentre, assessor-blind, 2×2 factorial, pragmatic randomised controlled trial; informed by a completed feasibility study.Participants:250 preterm infants and their parents.Intervention:MT focusing on parental singing specifically tailored to infant responses, will be delivered during NICU and/or during a postdischarge 6-month period.Primary outcome:changes in mother–infant bonding at 6-month corrected age (CA), as measured by the Postpartum Bonding Questionnaire.Secondary outcomes: mother–infant bonding at discharge and at 12-month CA; child development over 24 months; and parental depression, anxiety and stress, and infant rehospitalisation, all over 12 months.Ethics and disseminationThe Regional Committees for Medical and Health Research Ethics approved the study (2018/994/REK Nord, 03 July 2018). Service users were involved in development of the study and will be involved in implementation and dissemination. Dissemination of findings will apply to local, national and international levels.Trial registration numberNCT03564184

Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial

Gut ◽  
2020 ◽  
pp. gutjnl-2020-322026
Author(s):  
Vincent Huberty ◽  
Ivo Boskoski ◽  
Vincenzo Bove ◽  
Pauline Van Ouytsel ◽  
Guido Costamagna ◽  
...  
Keyword(s):  
Weight Loss ◽  
Lifestyle Modification ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Body Weight Loss ◽  
Total Body Weight ◽  
Control Group ◽  
Short Term ◽  
Randomised Controlled

ObjectiveEndoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium).DesignEligible patients (body mass index 30–40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG.ResultsOf the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%.ConclusionsThis study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment.Trial registration numberNCT03255005.

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