scholarly journals Different corticosteroid induction regimens in children and young people with juvenile idiopathic arthritis: the SIRJIA mixed-methods feasibility study

2020 ◽  
Vol 24 (36) ◽  
pp. 1-152
Author(s):  
Ashley P Jones ◽  
Dannii Clayton ◽  
Gloria Nkhoma ◽  
Frances C Sherratt ◽  
Matthew Peak ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Young People ◽  
Disease Activity ◽  
Health Care Professionals ◽  
Disease Activity Score ◽  
Controlled Trial ◽  
Juvenile Arthritis ◽  
Children And Young People ◽  
Randomised Controlled ◽  
The Uk

Background In the UK, juvenile idiopathic arthritis is the most common inflammatory disorder in childhood, affecting 10 : 100,000 children and young people aged < 16 years each year, with a population prevalence of around 1 : 1000. Corticosteroids are commonly used to treat juvenile idiopathic arthritis; however, there is currently a lack of consensus as to which corticosteroid induction regimen should be used with various disease subtypes and severities of juvenile idiopathic arthritis. Objective The main study objective was to determine the feasibility of conducting a randomised controlled trial to compare the different corticosteroid induction regimens in children and young people with juvenile idiopathic arthritis. Design This was a mixed-methods study. Work packages included a literature review; qualitative interviews with children and young people with juvenile idiopathic arthritis and their families; a questionnaire survey and screening log to establish current UK practice; a consensus meeting with health-care professionals, children and young people with juvenile idiopathic arthritis, and their families to establish the primary outcome; a feasibility study to pilot data capture and to collect data for future sample size calculations; and a final consensus meeting to establish the final protocol. Setting The setting was rheumatology clinics across the UK. Participants Children, young people and their families who attended clinics and health-care professionals took part in this mixed-methods study. Interventions This study observed methods of prescribing corticosteroids across the UK. Main outcome measures The main study outcomes were the acceptability of a future trial for children, young people, their families and health-care professionals, and the feasibility of delivering such a trial. Results Qualitative interviews identified differences in the views of children, young people and their families on a randomised controlled trial and potential barriers to recruitment. A total of 297 participants were screened from 13 centres in just less than 6 months. In practice, all routes of corticosteroid administration were used, and in all subtypes of juvenile idiopathic arthritis. Intra-articular corticosteroid injection was the most common treatment. The questionnaire surveys showed the varying clinical practice across the UK, but established intra-articular corticosteroids as the treatment control for a future trial. The primary outcome of choice for children, young people, their families and health-care professionals was the Juvenile Arthritis Disease Activity Score, 71-joint count. However, results from the feasibility study showed that, owing to missing blood test data, the clinical Juvenile Arthritis Disease Activity Score should be used. The Juvenile Arthritis Disease Activity Score, 71-joint count, and the clinical Juvenile Arthritis Disease Activity Score are composite disease activity scoring systems for juvenile arthritis. Two final trial protocols were established for a future randomised controlled trial. Limitations Fewer clinics were included in this feasibility study than originally planned, limiting the ability to draw strong conclusions about these units to take part in future research. Conclusions A definitive randomised controlled trial is likely to be feasible based on the findings from this study; however, important recommendations should be taken into account when planning such a trial. Future work This mixed-methods study has laid down the foundations to develop the evidence base in this area and conducting a randomised control trial to compare different corticosteroid induction regimens in children and young people with juvenile idiopathic arthritis is likely to be feasible. Study registration Current Controlled Trials ISRCTN16649996. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 36. See the NIHR Journals Library website for further project information.

scholarly journals Validity of a three-variable Juvenile Arthritis Disease Activity Score in children with new-onset juvenile idiopathic arthritis

2012 ◽  
Vol 72 (12) ◽  
pp. 1983-1988 ◽  
Author(s):  
Flora Mcerlane ◽  
Michael W Beresford ◽  
Eileen M Baildam ◽  
S E Alice Chieng ◽  
Joyce E Davidson ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Disease Activity ◽  
Clinical Setting ◽  
Disease Activity Score ◽  
Juvenile Arthritis ◽  
Activity Score ◽  
Childhood Arthritis ◽  
Disease Patterns ◽  
Routine Clinical Setting ◽  
The Uk

ObjectivesTo investigate the validity and feasibility of the Juvenile Arthritis Disease Activity Score (JADAS) in the routine clinical setting for all juvenile idiopathic arthritis (JIA) disease categories and explore whether exclusion of the erythrocyte sedimentation rate (ESR) from JADAS (the ‘JADAS3’) influences correlation with single markers of disease activity.MethodsJADAS-71, JADAS-27 and JADAS-10 were determined at baseline for an inception cohort of children with JIA in the Childhood Arthritis Prospective Study. JADAS3-71, JADAS3-27 and JADAS3-10 were determined using an identical formula but with exclusion of ESR. Correlation of JADAS with JADAS3 and single measures of disease activity/severity were determined by category.ResultsOf 956 eligible children, sufficient data were available to calculate JADAS-71, JADAS-27 and JADAS-10 at baseline in 352 (37%) and JADAS3 in 551 (58%). The median (IQR) JADAS-71, JADAS-27 and JADAS-10 for all 352 children was 11 (5.9–18), 10.4 (5.7–17) and 11 (5.9–17.3), respectively. Median JADAS and JADAS3 varied significantly with the category (Kruskal–Wallis p=0.0001), with the highest values in children with polyarticular disease patterns. Correlation of JADAS and JADAS3 across all categories was excellent. Correlation of JADAS71 with single markers of disease activity/severity was good to moderate, with some variation across the categories. With the exception of ESR, correlation of JADAS3-71 was similar to correlation of JADAS-71 with the same indices.ConclusionsThis study is the first to apply JADAS to all categories of JIA in a routine clinical setting in the UK, adding further information about the feasibility and construct validity of JADAS. For the majority of categories, clinical applicability would be improved by exclusion of the ESR.

scholarly journals Seroprevalence of Antibodies against SARS-CoV-2 in Children with Juvenile Idiopathic Arthritis a Case-Control Study

2021 ◽  
Vol 10 (8) ◽  
pp. 1771
Author(s):  
Violetta Opoka-Winiarska ◽  
Ewelina Grywalska ◽  
Izabela Korona-Glowniak ◽  
Katarzyna Matuska ◽  
Anna Malm ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Juvenile Arthritis ◽  
Activity Score ◽  
Control Group ◽  
Healthy Children ◽  
Serum Samples ◽  
History Of ◽  
Novel Coronavirus

There is limited data on the effect of the novel coronavirus disease (COVID-19) caused by severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) on pediatric rheumatology. We examined the prevalence of antibodies against SARS-CoV-2 in children with juvenile idiopathic arthritis (JIA) and a negative history of COVID-19 and the correlation of the presence of these antibodies with disease activity measured by juvenile arthritis disease activity score (JADAS). In total, 62 patients diagnosed with JIA, under treatment with various antirheumatic drugs, and 32 healthy children (control group) were included. Serum samples were analyzed for inflammatory markers and antibodies and their state evaluated with the juvenile arthritis disease activity score (JADAS). JIA patients do not have a higher seroprevalence of anti-SARS-CoV-2 antibodies than healthy subjects. We found anti-SARS-CoV-2 antibodies in JIA patients who did not have a history of COVID-19. The study showed no unequivocal correlation between the presence of SARS-CoV-2 antibodies and JIA activity; therefore, this relationship requires further observation. We also identified a possible link between patients’ humoral immune response and disease-modifying antirheumatic treatment, which will be confirmed in follow-up studies.

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

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

scholarly journals DECRYPT trial: study protocol for a phase II randomised controlled trial of cognitive therapy for post-traumatic stress disorder (PTSD) in youth exposed to multiple traumatic stressors

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e047600
Author(s):  
Leila Allen ◽  
Polly-Anna Ashford ◽  
Ella Beeson ◽  
Sarah Byford ◽  
Jessica Chow ◽  
...  
Keyword(s):  
Young People ◽  
Cognitive Therapy ◽  
Multiple Trauma ◽  
Traumatic Stress ◽  
Controlled Trial ◽  
Post Traumatic Stress ◽  
Children And Young People ◽  
Post Traumatic ◽  
Randomised Controlled ◽  
Post Randomisation

BackgroundPost-traumatic stress disorder (PTSD) is a distressing and disabling condition that affects significant numbers of children and adolescents. Youth exposed to multiple traumas (eg, abuse, domestic violence) are at particular risk of developing PTSD. Cognitive therapy for PTSD (CT-PTSD), derived from adult work, is a theoretically informed, disorder-specific form of trauma-focused cognitive–behavioural therapy. While efficacious for child and adolescent single-event trauma samples, its effectiveness in routine settings with more complex, multiple trauma-exposed youth has not been established. The Delivery of Cognitive Therapy for Young People after Trauma randomised controlled trial (RCT) examines the effectiveness of CT-PTSD for treating PTSD following multiple trauma exposure in children and young people in comparison with treatment as usual (TAU).Methods/designThis protocol describes a two-arm, patient-level, single blind, superiority RCT comparing CT-PTSD (n=60) with TAU (n=60) in children and young people aged 8–17 years with a diagnosis of PTSD following multiple trauma exposure. The primary outcome is PTSD severity assessed using the Children’s Revised Impact of Event Scale (8-item version) at post-treatment (ie, approximately 5 months post-randomisation). Secondary outcomes include structured interview assessment for PTSD, complex PTSD symptoms, depression and anxiety, overall functioning and parent-rated mental health. Mid-treatment and 11-month and 29-month post-randomisation assessments will also be completed. Process–outcome evaluation will consider which mechanisms underpin or moderate recovery. Qualitative interviews with the young people, their families and their therapists will be undertaken. Cost-effectiveness of CT-PTSD relative to TAU will be also be assessed.Ethics and disseminationThis trial protocol has been approved by a UK Health Research Authority Research Ethics Committee (East of England–Cambridge South, 16/EE/0233). Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations and clinical workshops.Trial registrationISRCTN12077707. Registered 24 October 2016 (http://www.isrctn.com/ISRCTN12077707). Trial recruitment commenced on 1 February 2017. It is anticipated that recruitment will continue until June 2021, with 11-month assessments being concluded in May 2022.

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

2020 ◽  
Author(s):  
Laura Williams ◽  
Charlotte L Hall ◽  
Sue Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Stimulant Medication ◽  
Controlled Trial ◽  
Medication Management ◽  
Control Group ◽  
Global Functioning ◽  
Children And Young People ◽  
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); participants completed a QbTest at baseline and two follow-up QbTests on medication (2-4 weeks and 8-10 weeks later). Control; 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 52-78% 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, p=0.01). 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: Prospectively registered with Clinicaltrials.gov (NCT03368573, 11th December 2017, https://clinicaltrials.gov/ct2/show/NCT03368573) and retrospectively with ISRCTN (ISRCTN69461593, 10th April 2018, http://www.isrctn.com/ISRCTN69461593).

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