1,721,016 research outputs found
Clustering of continuous and binary outcomes at the general practice level in individually randomised studies in primary care - a review of 10 years of primary care trials
No full textBackground: in randomised controlled trials, the assumption of independence of individual observations is fundamental to the design, analysis and interpretation of studies. However, in individually randomised trials in primary care, this assumption may be violated because patients are naturally clustered within primary care practices. Ignoring clustering may lead to a loss of power or, in some cases, type I error. Methods: Clustering can be quantified by intra-cluster correlation (ICC), a measure of the similarity between individuals within a cluster with respect to a particular outcome. We reviewed 17 trials undertaken by the Department of Primary Care at the University of Southampton over the last ten years. We calculated the ICC for the primary and secondary outcomes in each trial at the practice level and determined whether ignoring practice-level clustering still gave valid inferences. Where multiple studies collected the same outcome measure, the median ICC was calculated for that outcome. Results: The median intra-cluster correlation (ICC) for all outcomes was 0.016, with interquartile range 0.00-0.03. The median ICC for symptom severity was 0.02 (interquartile range (IQR) 0.01 to 0.07) and for reconsultation with new or worsening symptoms was 0.01 (IQR 0.00, 0.07). For HADS anxiety the ICC was 0.04 (IQR 0.02, 0.05) and for HADS depression was 0.02 (IQR 0.00, 0.05). The median ICC for EQ5D-3L was 0.01 (IQR 0.01, 0.04) Conclusions: There is evidence of clustering in individually randomised trials primary care. The non-zero ICC suggests that, depending on study design, clustering may not be ignorable. It is important that this is fully considered at the study design phase.<br/
A causal model for longitudinal randomised trials with time‐dependent non‐compliance
No full textIn the presence of non-compliance, conventional analysis by intention-to-treat provides an unbiased comparison of treatment policies but typically under-estimates treatment efficacy. With all-or-nothing compliance, efficacy may be specified as the complier-average causal effect (CACE), where compliers are those who receive intervention if and only if randomised to it. We extend the CACE approach to model longitudinal data with time-dependent non-compliance, focusing on the situation in which those randomised to control may receive treatment and allowing treatment effects to vary arbitrarily over time. Defining compliance type to be the time of surgical intervention if randomised to control, so that compliers are patients who would not have received treatment at all if they had been randomised to control, we construct a causal model for the multivariate outcome conditional on compliance type and randomised arm. This model is applied to the trial of alternative regimens for glue ear treatment evaluating surgical interventions in childhood ear disease, where outcomes are measured over five time points, and receipt of surgical intervention in the control arm may occur at any time. We fit the models using Markov chain Monte Carlo methods to obtain estimates of the CACE at successive times after receiving the intervention. In this trial, over a half of those randomised to control eventually receive intervention. We find that surgery is more beneficial than control at 6months, with a small but non-significant beneficial effect at 12months.</p
The admission of older patients to a dedicated short stay medical unit: Learning from experience
No full textThe admission of older patients with acute medical problems to short stay medical units (SSMUs) is controversial in light of their longer expected length of in-patient stay (LoS), coupled with the greater resources required by such a department. We undertook a prospective study of 120 consecutive SSMU patients aged 60 years or over, to find out whether information gained during the admissions process could predict which candidates would subsequently have a successful SSMU outcome, as well as to assess the overall suitability of the SSMU to older patients. Our redesigned acute medicine services at Addenbrooker's Hospital (Cambridge, UK) have taken account of our results, and we continue to admit older patients to our new Medical Short Stay Emergency Unit.</p
Point of care testing using FebriDx ® to improve antibiotic use for respiratory tract infections in primary care (PREFIX): study procol for a mixed methods feasibility study
No full textThe effects of acute hospitalisation on the characteristics of acute sarcopenia in older adults: a systematic review and meta-analysis
No full textBackground: acute sarcopenia in hospitalised older adults is associated with poor outcomes, such as functional decline, increased risk of falls and prolonged hospital stays. Despite this, its development among older inpatients remains poorly understood. We aimed to quantify the effects of acute hospitalisation on sarcopenia outcomes in older adults.Methods: MEDLINE, EMBASE, CINAHL, and Web of Science were searched from inception until January 2025. Studies that included acutely admitted patients aged 65 years or older and reported changes in at least one measure of sarcopenia during hospitalisation were included. Barthel Index was also included. A random-effects meta-analysis was undertaken.Results: fifty five eligible studies were included, with a participant mean age of 82.2 years (n = 14,919 participants). Our meta-analysis showed grip strength and chair-to-stand performance to significantly increase during hospitalisation (standard mean difference [SMD] = 0.06, 95% confidence interval [CI]: 0.00; 0.13, I2 = 3%, p = 0.05 and SMD = 0.23, 95% CI: 0.13; 0.33, I2 = 0%, p <0.01, respectively). No physical performance measure showed a significant change. Muscle mass showed no change when measured by bioelectrical impedance analysis (SMD = 0.01, 95% CI: -0.09; 0.08, I2 = 0%, p = 0.86). There were insufficient studies using MRI (n = 2) or DEXA (n = 1) to perform a meta-analysis. Individual studies showed a significant decrease in mid-thigh muscle area (cm2) by MRI (mean difference [MD] = -3.9, p <0.01) and a significant decrease in leg lean mass (kg) by DEXA (MD = -0.16, p <0.05). Barthel Index score significantly increased from admission to discharge (SMD = 0.26, 95% CI: 0.06; 0.46, I2 = 98.0%, p = 0.01) but significantly decreased from pre-admission to discharge (SMD = -0.66, 95% CI: -0.92; -0.39, I2 = 97.5%, p <0.001). Both age and hospital length of stay had no effect on grip strength (p = 0.615 and p = 0.096) or Barthel Index (p = 0.835 and p = 0.279). Conclusions: this review has shown that grip strength improves during hospitalisation and decreases in muscle mass are observed when measured using MRI or DEXA. Muscle strength and physical performance assessed on admission are poor indicators of baseline status, as they are often adversely affected during acute illness, making them unrepresentative of true baseline capacity. The lack of improvement in physical performance outcomes is an important finding as it represents failure to return to pre-hospital baseline abilities.<br/
Influence of external peer reviewer scores for funding applications on funding board decisions: A retrospective analysis of 1561 reviews
Full text linkObjectives To evaluate the influence of external peer reviewer scores on the National Institute for Health Research (NIHR) research funding board decisions by the number of reviewers and type of reviewer expertise Design Retrospective analysis of external peer review scores for shortlisted full applications for funding (280 funding applications, 1236 individual reviewers, 1561 review scores) Setting Four applied health research funding programmes of NIHR, UK Main outcome measures Board decision to fund or not fund research applications Results The mean score of reviewers predicted funding decisions better than individual reviewer scores (area under the receiver operating characteristic (ROC) curve 075, 95% CI 069 to 081 compared with 062, CI 059 to 065) There was no substantial improvement in how accurately mean reviewer scores predicted funding decisions when the number of reviewers increased above 4 (area under ROC curve 075, CI 059 to 091 for four reviewers; 080, CI 067 to 092 for seven or more) Reviewers with differing expertise influenced the board's decision equally, including public and patient reviewers (area under ROC curves from 057, CI 047 to 066 for health economists to 064, CI 057 to 070 for subject-matter experts) The areas under the ROC curves were quite low when using reviewers' scores, confirming that boards do not rely solely on those scores alone to make their funding decisions, which are best predicted by the mean board score Conclusions Boards value scores that originate from a diverse pool of reviewers On the basis of independent reviewer score alone, there is no detectable benefit of using more than four reviewer scores in terms of their influence on board decisions, so to improve efficiency, it may be possible to avoid using larger numbers of reviewers The funding decision is best predicted by the board score</p
Predictors of prolonged symptoms following COVID-19 and other respiratory infections
No full textBackground: post-viral syndromes following respiratory tract infections have been described for years. Early studies of COVID-19 have suggested that around 2% of people who develop acute infection will still have symptoms at 12 weeks. Understanding predictors of prolonged symptoms may help inform early management and healthcare planning.Aim: to explore predictors of prolonged symptoms in a community cohort reporting acute respiratory tract infection during the first year of the COVID-19 pandemic.Methods:We conducted an online survey of adults through advertising to the public and invitations sent by general practices. Participants were asked to report details of any respiratory infections lasting 3 days or more and asked to report any prolonged symptoms in a follow-up survey sent 3-months later. Clustering of prolonged symptoms was explored using factor analysis. Demographics, past medical history, and features of the acute illness were all considered as potential predictors. We used LASSO to select predictors and then logistic regression to estimate the association with experiencing prolonged symptoms.Results: 1,942 participants reported an ARI in the baseline questionnaire and completed a 3-month follow-upquestionnaire. Of these, 464 (23.9%) reported having prolonged symptoms. The most common prolonged symptoms were tiredness, ‘brain fog’ and shortness of breath. Preliminary analysis has identified having laboratory confirmed or ‘probable’ COVID, older age, female sex, greater socioeconomic deprivation, greater concern about the initial illness, and shortness of breath, loss of taste and skin rash, as predictors of prolonged symptoms.Discussion: the analysis is ongoing and will be presented at the meeting
Randomized trial within a trial of yellow 'post-it notes' did not improve questionnaire response rates among participants in a trial of treatments for neck pain
No full textRationale Attrition is a threat to the validity of randomized trials. Few randomized studies have been conducted within randomized trials to test methods of reducing attrition. Aim To test whether using yellow post-it notes on follow-up questionnaires in the ATLAS treatment trial for neck pain reduces attrition. Method Nested trial within a trial. ATLAS participants were randomized to have their 6-month follow-up questionnaire have a 3′ yellow post-it note with a handwritten message encouraging return of questionnaire. Results 499 participants were independently randomized using simple allocation to receive the post-it notes or not. Two hundred fifteen of the 256 (84.0%) participants in the intervention group returned their questionnaire compared with 205 of the 243 (84.4%) in the control group. There was no difference in time to response. Conclusion Yellow post-it notes do not enhance questionnaire return rates for participants in a randomized trial of neck pain.</p
Use of the FebriDx® host-response point-of-care test may reduce antibiotic use for respiratory tract infections in primary care: a mixed-methods feasibility study
No full textINTRODUCTION: FebriDx® is a CE-marked, single-use point-of-care test with markers for bacterial [C-reactive protein (CRP)] and viral [myxovirus resistance protein A (MxA)] infection, using finger-prick blood samples. Results are available after 10-12 min. We explored the usability and potential impact of FebriDx® in reducing antibiotic prescriptions for lower respiratory tract infection (LRTI) in primary care, and the feasibility of conducting a randomized controlled trial (RCT).METHODS: Patients (aged ≥1 year) with LRTI deemed likely to receive antibiotic prescription were recruited at nine general practices and underwent FebriDx® testing. Data collection included FebriDx® results, antibiotic prescribing plan (before and after testing) and re-consultation rates. Staff completed System Usability Scale questionnaires.RESULTS: From 31 January 2023 to 9 June 2023, 162 participants participated (median age 57 years), with a median symptom duration of 7 days (IQR 5-14). A valid FebriDx® result was obtained in 97% (157/162). Of 155 patients with available results, 103 (66%) had no detectable CRP or MxA, 28 (18%) had CRP only, 5 (3%) had MxA only, and 19 (12%) had both CRP and MxA. The clinicians' stated management plan was to prescribe antibiotics for 86% (134/155) before testing and 45% (69/155) after testing, meaning a 41% (95% CI: 31%, 51%) difference after testing, without evidence of increased re-consultation rates. Ease-of-use questionnaires showed 'good' user-friendliness.CONCLUSIONS: Use of FebriDx® to guide antibiotic prescribing for LRTI in primary care was associated with a substantial reduction in prescribing intentions. These results support a fully powered RCT to confirm its impact and safety.</p
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