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2 results on '"Isabel Reading"'

1. CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial

Author

Natalie Hutchings, Wendy Wood, Isabel Reading, Erin Walker, Jane M. Blazeby, William van’t Hoff, Bridget Young, Esther M. Crawley, Simon Eaton, Maria Chorozoglou, Frances C. Sherratt, Lucy Beasant, Harriet Corbett, Michael P. Stanton, Simon Grist, Elizabeth Dixon, and Nigel J. Hall

Subjects
Appendicitis, Non-operative treatment, Paediatric surgery, Appendicectomy, Feasibility, Medicine (General), R5-920
Abstract

Abstract Background Currently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial. Methods/design The study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4–15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment pathways, clinical outcomes and safety of non-operative treatment. We have involved children, young people and parents in study design and delivery. Discussion In this study we will explore the feasibility of performing a full efficacy RCT comparing non-operative treatment with appendicectomy in children with acute uncomplicated appendicitis. Factors determining success of the present study include recruitment rate, safety of non-operative treatment and adequate interest in the future RCT. Ultimately this feasibility study will form the foundation of the main RCT and reinforce its design. Trial registration ISRCTN15830435. Registered on 8 February 2017.

Published
2018
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2. Prevention of Morbidity in Sickle Cell Disease (POMS2a)—overnight auto-adjusting continuous positive airway pressure compared with nocturnal oxygen therapy: a randomised crossover pilot study examining patient preference and safety in adults and children

Author

Eufemia Jacob, Maria Chorozoglou, Maureen Gwam, Baba Inusa, Sophie A. Lee, Carol Ossai, Johanna Gavlak, Jo Howard, Man Ying Edith Cheng, Patrick B. Murphy, Sati Sahota, Atul Gupta, Nicholas Hart, Sally Ann Wakeford, Angela Wade, Isabel Reading, Fenella J. Kirkham, Cheema Bavenjit, and Christina Liossi

Subjects
Male, Time Factors, medicine.medical_treatment, Psychological intervention, Medicine (miscellaneous), Pilot Projects, Pulmonary function testing, 0302 clinical medicine, Oxygen therapy, London, Pharmacology (medical), 030212 general & internal medicine, Continuous positive airway pressure, Child, Lung, Sleep Apnea, Obstructive, lcsh:R5-920, Cross-Over Studies, Continuous Positive Airway Pressure, Patient Preference, Middle Aged, Treatment Outcome, Bone marrow suppression, Female, Haemoglobin, lcsh:Medicine (General), Statistical method, Adult, medicine.medical_specialty, Adolescent, Pain, Anemia, Sickle Cell, Respiratory physiology, Qualitative method, Young Adult, 03 medical and health sciences, Randomised crossover trial, Internal medicine, medicine, Humans, Inherited diseases, business.industry, Research, Sickle cell anaemia, Oxygen Inhalation Therapy, Crossover study, Confidence interval, Quality of Life, business, 030217 neurology & neurosurgery
Abstract

DESIGN: This randomised crossover trial compared nocturnal auto-adjusting continuous positive airway pressure (APAP) and nocturnal oxygen therapy (NOT) in adults and children with sickle cell anaemia, with patient acceptability as the primary outcome. Secondary outcomes included pulmonary physiology (adults), safety, and daily pain during interventions and washout documented using tablet technology.METHODS: Inclusion criteria were age > 8 years and the ability to use an iPad to collect daily pain data. Trial participation was 4 weeks; week 1 involved baseline data collection and week 3 was a washout between interventions, which were administered for 7 days each during weeks 2 and 4 in a randomised order. Qualitative interviews were transcribed verbatim and analysed for content using a funnelling technique, starting generally and then gaining more detailed information on the experience of both interventions. Safety data included routine haematology and median pain days between each period. Missing pain day values were replaced using multiple imputation.RESULTS: Ten adults (three female, median age 30.2 years, range 18-51.5 years) and eleven children (five female, median age 12 years, range 8.7-16.9 years) enrolled. Nine adults and seven children completed interviews. Qualitative data revealed that the APAP machine was smaller, easier to handle, and less noisy. Of 16 participants, 10 preferred APAP (62.5%, 95% confidence interval (CI) 38.6-81.5%). Haemoglobin decreased from baseline on APAP and NOT (mean difference -3.2 g/L (95% CI -6.0 to -0.2 g/L) and -2.5 g/L (95% CI -4.6 to 0.3 g/L), respectively), but there was no significant difference between interventions (NOT versus APAP, 1.1 (-1.2 to 3.6)). Pulmonary function changed little. Compared with baseline, there were significant decreases in the median number of pain days (1.58 for APAP and 1.71 for NOT) but no significant difference comparing washout with baseline. After adjustment for carry-over and period effects, there was a non-significant median difference of 0.143 (95% CI -0.116 to 0.401) days additional pain with APAP compared with NOT.CONCLUSION: In view of the point estimate of patient preference for APAP, and no difference in haematology or pulmonary function or evidence that pain was worse during or in washout after APAP, it was decided to proceed with a Phase II trial of 6 months APAP versus standard care with further safety monitoring for bone marrow suppression and pain.TRIAL REGISTRATION: ISRCTN46078697 . Registered on 18 July 2014.

Published
2019

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