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Journal articleRay AF, Powell J, Speakman MJ, et al., 2018,
Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study)
, BJU INTERNATIONAL, Vol: 122, Pages: 270-282, ISSN: 1464-4096ObjectivesTo assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP).Patients and MethodsAs a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK‐ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post‐procedure, and complication data post‐PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non‐inferiority analysis on propensity‐score‐matched patient pairs. The clinical results and urological measurements were performed at clinical sites. IPSS and other questionnaire‐based results were mailed by patients directly to the trial unit managing the study. All data were uploaded centrally to the UK‐ROPE study database.ResultsThe results showed that PAE was clinically effective, producing a median 10‐point IPSS improvement from baseline at 12 months post‐procedure. PAE did not appear to be as effective as TURP, which produced a median 15‐point IPSS score improvement at 12 months post‐procedure. These findings are further supported by the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality‐of‐life (QoL) improvement, there was no evidence of PAE being non‐inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post‐procedure. PAE
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Journal articleKwakkenbos L, Imran M, McCord K, et al., 2018,
Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data
, BMJ Open, Vol: 8, ISSN: 2044-6055Introduction: Randomised controlled trials (RCTs) conducted using cohorts and routinely collected health data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. The development of an extension of the CONsolidated Standards of Reporting Trials (CONSORT) statement for RCTs using cohorts and routinely collected health data is being undertaken with the goal of improving reporting quality by setting standards early in the process of uptake of these designs. To develop this extension to the CONSORT statement, a scoping review will be conducted to identify potential modifications or clarifications of existing reporting guideline items, as well as additional items needed for reporting RCTs using cohorts and routinely collected health data.Methods and analysis: In separate searches, we will seek publications on methods or reporting or that describe protocols or results from RCTs using cohorts, registries, electronic health records and administrative databases. Data sources will include Medline and the Cochrane Methodology Register. For each of the four main types of RCTs using cohorts and routinely collected health data, separately, two investigators will independently review included publications to extract potential checklist items. A potential item will either modify an existing CONSORT 2010, Strengthening the Reporting of Observational Studies in Epidemiology or REporting of studies Conducted using Observational Routinely collected health Data item or will be proposed as a new item. Additionally, we will identify examples of good reporting in RCTs using cohorts and routinely collected health data.Ethics and dissemination: The proposed scoping review will help guide the development of the CONSORT extension statement for RCTs conducted using cohorts and routinely collected health data.
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Journal articleKnight M, 2018,
Improving intrapartum care: can we use routinely available data to monitor the effects of our actions?
, Arch Dis Child Fetal Neonatal Ed, Vol: 103, Pages: F296-F297 -
Journal articleDuffy JMN, Hirsch M, Pealing L, et al., 2018,
Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation
, BJOG: An International Journal of Obstetrics and Gynaecology, Vol: 125, Pages: 795-803, ISSN: 1470-0328© 2017 Royal College of Obstetricians and Gynaecologists Background: Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. Objective: To assess safety reporting in pre-eclampsia trials. Search strategy: Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. Selection criteria: Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. Data collection and analysis: Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. Main results: We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating ‘safety and toleration’ and ‘possible side effects’ would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. Conclusions: Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. Tweetable abstract: Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC.
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Journal articleModi N, 2018,
A radical proposal: to promote children's wellbeing give them the vote This straightforward change might ensure that child friendly policies get political attention
, BMJ-BRITISH MEDICAL JOURNAL, Vol: 361, ISSN: 1756-1833 -
Journal articleWinch R, McColgan MP, Sparrow E, et al., 2018,
Public and patient involvement in child health research and service improvements: a survey of hospital doctors
, BMJ Paediatrics Open, Vol: 2, ISSN: 2399-9772Objectives: To determine whether paediatricians are supported by their organisations to encourage patient and public involvement (PPI) in research activities and clinical improvement work, the challenges they face and how they think these could be addressed by the Royal College of Paediatrics and Child Health (RCPCH). Design: A survey. Setting: UK consultant paediatricians and staff associate specialist and specialty (SAS) doctors who are members of RCPCH. Main outcome measures: The proportion of respondents who said that PPI was central to research and service improvements in their organisation, the type of local support for PPI activity, challenges in undertaking PPI and the support members wanted from RCPCH. Results: There was a response rate of 44.4% (n=1924). In their organisation, 29.1% of respondents stated PPI was central to research and 36.1% to service improvement; 46% were unaware of support for PPI and 15% said there was no support. The main challenges for PPI activity were a lack of clinician time, local support and funding. Respondents wanted RCPCH to advocate for protected time for PPI, provide access to PPI groups and deliver guidance and training. Conclusions: The majority of paediatricians feel unsupported to undertake PPI activity by their local organisation. The RCPCH has a key role to enable all paediatricians to work with children, young people and their carers to improve the quality of research and clinical services as demonstrated by RCPCH's ongoing activity in these crucial and important areas.
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Journal articleTrück J, Kelly S, Jawad S, et al., 2018,
Differences in Immunization Site Pain in Toddlers Vaccinated With Either the 10- or the 13-Valent Pneumococcal Conjugate Vaccine
, The Pediatric Infectious Disease Journal, ISSN: 0891-3668 -
Journal articleHelenius K, Sjörs G, Shah PS, et al., 2018,
Survival in very preterm infants: An international comparison of 10 national neonatal networks
, Obstetrical and Gynecological Survey, Vol: 73, Pages: 187-189, ISSN: 0029-7828 -
Journal articleBurns RM, Wolstenholme J, Jawad S, et al., 2018,
Economic analysis of oral dexamethasone for symptom relief of sore throat: the UK TOAST study
, BMJ OPEN, Vol: 8, ISSN: 2044-6055Objectives To undertake an economic analysis assessing the cost-effectiveness of a single dose of oral dexamethasone compared with placebo for the relief of sore throat.Design A UK-based, multicentre, two arm, individually randomised, double blind trial.Setting and population Adults (≥18 years) with acute sore throat and painful swallowing judged to be infective in origin, recruited and randomised in primary care. Intervention: a single dose of 10 mg oral dexamethasone compared with placebo given at primary care visit.Main outcome Incremental cost-effectiveness ratios (ICERs), cost per quality-adjusted symptom resolution using the EuroQol-five dimensions-five levels instrument, were estimated as part of a cost–utility analysis performed on an intention-to-treat cohort adopting a health payers perspective.Results Differences in health-related quality of life (HRQoL) over 7 days from baseline and at 24 hours in the dexamethasone compared with the placebo group (2.9% and 2.5% higher, respectively) were observed. After controlling for the baseline HRQoL imbalances, the economic impact of the intervention was not statistically significant: the quality-adjusted life year difference was −0.00005 (95% CI −0.0002 to 0.00011) equivalent to a loss in HRQoL of a half hour in the dexamethasone group. The average cost per patient associated in the dexamethasone and placebo groups in the basecase analysis was £73 and £69, respectively. In the basecase probabilistic analysis, the mean ICER was −£6440 (95% CI −£132 151 to £126 335) and the median ICER was −£304 (IQR-£5816 to £3877); suggesting considerable uncertainty.Conclusions and relevance The economic burden associated with sore throat is substantial and was estimated at £2.35 billion to the healthcare services payer based on reported resource use and 2015 UK unit costs. There is considerable uncertainty regarding the cost
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Journal articleGale CRK, 2018,
Family integrated care for very preterm infants: evidence for a practice that seems self-evident?
, Lancet Child and Adolescent Health, Vol: 2, Pages: 230-231, ISSN: 2352-4642
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