Objectives(1) To develop methods for conducting cluster randomised trials of text messaging interventions utilising routine electronic health records at low cost; (2) to assess the effectiveness of text messaging influenza vaccine reminders in increasing vaccine uptake in patients with chronic conditions.DesignCluster randomised trial with general practices as clusters.SettingEnglish primary care.Participants156 general practices, who used text messaging software, who had not previously used text message influenza vaccination reminders. Eligible patients were aged 18–64 in ‘at-risk’ groups.InterventionsPractices were randomly allocated to either an intervention or standard care arm in the 2013 influenza season (September to December). Practices in the intervention arm were asked to send a text message influenza vaccination reminder to their at-risk patients under 65. Practices in the standard care arm were asked to continue their influenza campaign as planned.BlindingPractices were not blinded. Analysis was performed blinded to practice allocation.Main outcome measuresPractice-level influenza vaccine uptake among at-risk patients aged 18–64 years.Results77 practices were randomised to the intervention group (76 analysed, n at-risk patients=51 121), 79 to the standard care group (79 analysed, n at-risk patients=51 136). The text message increased absolute vaccine uptake by 2.62% (95% CI −0.09% to 5.33%), p=0.058, though this could have been due to chance. Within intervention clusters, a median 21.0% (IQR 10.2% to 47.0%) of eligible patients were sent a text message. The number needed to treat was 7.0 (95% CI −0.29 to 14.3).ConclusionsPatient follow-up using routine electronic health records is a low cost method of conducting cluster randomised trials. Text messaging reminders are likely to result in modest improvements in influenza vaccine uptake, but levels of patients being texted need to markedly increase if text messaging reminders are to have much effect.Trial registration numberISRCTN48840025.
In a randomized comparison of nevirapine or abacavir with zidovudine plus lamivudine, routine viral load monitoring was not performed, yet 27% of individuals with viral failure at week 48 experienced resuppression by week 96 without switching. This supports World Health Organization recommendations that suspected viral failure should trigger adherence counseling and repeat measurement before a treatment switch is considered.
Our findings have implications for the choice of primary outcome measure in prion disease clinical trials. Prion disease presents the unusual opportunity to follow patients with a neurodegenerative disease through their entire clinical course, and this provides insights relevant to designing outcome measures in related conditions.
In UK primary care database studies, methods for identifying breast, colorectal, and prostate cancers were often unclear. Code lists were often unavailable, and where provided, we observed variation in the individual codes and types of codes included. Clearer reporting of methods and publication of code lists would improve transparency and reproducibility of studies.
Background/Aims: Large clinical trials including patients with uncommon diseases involve assessors in different geographical locations, resulting in considerable inter-rater variability in assessment scores. As video recordings of examinations, which can be individually rated, may eliminate such variability, we measured the agreement between a single video rater and multiple examining physicians in the context of PRION-1, a clinical trial of the antimalarial drug quinacrine in human prion diseases. Methods: We analysed a 43-component neurocognitive assessment battery, on 101 patients with Creutzfeldt-Jakob disease, focusing on the correlation and agreement between examining physicians and a single video rater. Results: In total, 335 videos of examinations of 101 patients who were video-recorded over the 4-year trial period were assessed. For neurocognitive examination, inter-observer concordance was generally excellent. Highly visual neurological examination domains (e.g. finger-nose-finger assessment of ataxia) had good inter-rater correlation, whereas those dependent on non-visual clues (e.g. power or reflexes) correlated poorly. Some non-visual neurological domains were surprisingly concordant, such as limb muscle tone. Conclusion: Cognitive assessments and selected neurological domains can be practically and accurately recorded in a clinical trial using video rating. Video recording of examinations is a valuable addition to any trial provided appropriate selection of assessment instruments is used and rigorous training of assessors is undertaken.
PRION-1, the largest clinical trial in prion disease to date, showed no effect of the experimental therapeutic quinacrine on survival. Here we report analyses showing that quinacrine had no demonstrable benefit (p>0.4) when assessed by a range of rating scales. These included neurocognitive (Mini-Mental State Examination, ADAScog), psychiatric (Brief Psychiatric Rating Scale), global (Rankin and Global Impression of Change), clinician-rated (Clinician's Dementia Rating (CDR)) and functional (Barthel) scales. These rating scales have several potential benefits over survival as an outcome measure: here we assess their validity and performance over 77 person-years follow-up in 101 symptomatic patients in PRION-1. Overall, across a range of models applied, we found that the Barthel and CDR scales were most robust to the difficulties posed by a prion disease clinical trial. A combination of selected subcomponents from these two scales gave increased power to detect clinically relevant effects in a future clinical trial of feasible size, compared to use of survival alone. We also discuss our work refining the use of these scales in the National Prion Monitoring Cohort, an ongoing prospective observational study of all types of human prion disease in the UK, and how this will inform the planning of future therapeutic trials.
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