24 research outputs found
Protocol for an ‘efficient design’ cluster randomised controlled trial to evaluate a complex intervention to improve antibiotic prescribing for CHIldren presenting to primary care with acute COugh and respiratory tract infection:the CHICO study
No full textIntroduction Respiratory tract infections (RTIs) in children are common and present major resource implications for primary care. Unnecessary use of antibiotics is associated with the development and proliferation of antimicrobial resistance. In 2016, the National Institute for Health Research (NIHR)-funded ‘TARGET’ programme developed a prognostic algorithm to identify children with acute cough and RTI at very low risk of 30-day hospitalisation and unlikely to need antibiotics. The intervention includes: (1) explicit elicitation of parental concerns, (2) the results of the prognostic algorithm accompanied by prescribing guidance and (3) provision of a printout for carers including safety netting advice. The CHIldren’s COugh feasibility study suggested differential recruitment of healthier patients in control practices. This phase III ‘efficiently designed’ trial uses routinely collected data at the practice level, thus avoiding individual patient consent. The aim is to assess whether embedding a multifaceted intervention into general practitioner (GP) practice Information Technology (IT) systems will result in reductions of antibiotic prescribing without impacting on hospital attendance for RTI.Methods and analysis The coprimary outcomes are (1) practice rate of dispensed amoxicillin and macrolide antibiotics, (2) hospital admission rate for RTI using routinely collected data by Clinical Commissioning Groups (CCGs). Data will be collected for children aged 0–9 years registered at 310 practices (155 intervention, 155 usual care) over a 12-month period. Recruitment and randomisation of practices (using the Egton Medical Information Systems web data management system) is conducted via each CCG stratified for children registered and baseline dispensing rates of each practice. Secondary outcomes will explore intervention effect modifiers. Qualitative interviews will explore intervention usage. The economic evaluation will be limited to a between-arm comparison in a cost–consequence analysis.Ethics and dissemination Research ethics approval was given by London-Camden and Kings Cross Research Ethics Committee (ref:18/LO/0345). This manuscript refers to protocol V.4.0. Results will be disseminated through peer-reviewed journals and international conferences.Trial registration number ISRCTN11405239
Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England?
No full textObjectives Conducting randomised controlled trials (RCTs) in primary care is challenging; recruiting patients during time-limited or remote consultations can increase selection bias and physical access to patients’ notes is costly and time-consuming. We investigated barriers and facilitators to running a more efficient design.
Design An RCT aiming to reduce antibiotic prescribing among children presenting with acute cough and a respiratory tract infection (RTI) with a clinician-focused intervention, embedded at the practice level. By using aggregate level, routinely collected data for the coprimary outcomes, we removed the need to recruit individual participants.
Setting Primary care.
Participants Baseline data from general practitioner practices and interviews with individuals from Clinical Research Networks (CRNs) in England who helped recruit practices and Clinical Commission Groups (CCGs) who collected outcome data.
Intervention The intervention included: (1) explicit elicitation of parental concerns, (2) a prognostic algorithm to identify children at low risk of hospitalisation and (3) provision of a printout for carers including safety-netting advice.
Coprimary outcomes For 0–9 years old—(1) Dispensing data for amoxicillin and macrolide antibiotics and (2) hospital admission rate for RTI.
Results We recruited 294 of the intended 310 practices (95%) representing 336 496 registered 0–9 years old (5% of all 0–9 years old children). Included practices were slightly larger, had slightly lower baseline prescribing rates and were located in more deprived areas reflecting the national distribution. Engagement with CCGs and their understanding of their role in this research was variable. Engagement with CRNs and installation of the intervention was straight-forward although the impact of updates to practice IT systems and lack of familiarity required extended support in some practices. Data on the coprimary outcomes were almost 100%.
Conclusions The infrastructure for trials at the practice level using routinely collected data for primary outcomes is viable in England and should be promoted for primary care research where appropriate.
Trial registration number ISRCTN11405239
A multifaceted intervention to reduce antibiotic prescribing among CHIldren with acute COugh and respiratory tract infection: the CHICO cluster RCT
No full textBACKGROUND: Clinical uncertainty in primary care regarding the prognosis of children with respiratory tract infections contributes to the unnecessary use of antibiotics. Improved identification of children at low risk of future hospitalisation might reduce clinical uncertainty. A National Institute for Health and Care Research-funded 5-year programme (RP-PG-0608-10018) was used to develop and feasibility test an intervention.OBJECTIVES: The aim of the children with acute cough randomised controlled trial was to reduce antibiotic prescribing among children presenting with acute cough and respiratory tract infection without increasing hospital admission.DESIGN: An efficient, pragmatic open-label, two-arm trial (with embedded qualitative and health economic analyses) using practice-level randomisation using routinely collected data as the primary outcome.SETTING: General practitioner practices in England.PARTICIPANTS: General practitioner practices using the Egton Medical Information Systems
® patient-record system for children aged 0-9 years presenting with a cough or upper respiratory tract infection. Recruited by Clinical Research Networks and Clinical Commissioning Groups.
INTERVENTION: Comprised: (1) elicitation of parental concerns during consultation; (2) a clinician-focused prognostic algorithm to identify children with acute cough and respiratory tract infection at low, average or elevated risk of hospitalisation in the next 30 days accompanied by prescribing guidance, (3) provision of a printout for carers including safety-netting advice.MAIN OUTCOME MEASURES: Co-primaries using the practice list-size for children aged 0-9 years as the denominator: rate of dispensed amoxicillin and macrolide items at each practice (superiority comparison) from
NHS Business Services Authority ePACT2 and rate of hospital admission for respiratory tract infection (non-inferiority comparison) from Clinical Commissioning Groups, both routinely collected over 12 months.
RESULTS: Of the 310 practices required, 294 (95%) were recruited (144 intervention and 150 controls) with 336,496 registered 0-9-year-olds (5% of all 0-9-year-old children in England) from 47 Clinical Commissioning Groups. Included practices were slightly larger than those not included, had slightly lower baseline dispensing rates and were located in more deprived areas (reflecting the distribution for practice postcodes nationally). Twelve practices (4%) subsequently withdrew (six related to the pandemic). The median number of times the intervention was used was 70 per practice (by a median of 9 clinicians) over 12 months. There was no evidence that the antibiotic dispensing rate in the intervention practices [0.155 (95% confidence interval 0.135 to 0.179)] differed to controls [0.154 (95% confidence interval 0.130 to 0.182), relative risk= 1.011 (95% confidence interval 0.992 to 1.029);
p = 0.253]. There was, overall, a reduction in dispensing levels and intervention usage during the pandemic. The rate of hospitalisation for respiratory tract infection in the intervention practices [0.019 (95% confidence interval 0.014 to 0.026)] compared to the controls [0.021 (95% confidence interval 0.014 to 0.029)] was non-inferior [relative risk = 0.952 (95% confidence interval 0.905 to 1.003)]. The qualitative evaluation found the clinicians liked the intervention, used it as a supportive aid, especially with borderline cases but that it, did not always integrate well within the consultation flow and was used less over time. The economic evaluation found no evidence of a difference in mean National Health Service costs between arms; mean difference -£1999 (95% confidence interval -£6627 to 2630).
CONCLUSIONS: The intervention was feasible and subjectively useful to practitioners, with no evidence of harm in terms of hospitalisations, but did not impact on antibiotic prescribing rates.FUTURE WORK AND LIMITATIONS: Although the intervention does not appear to change prescribing behaviour, elements of the approach may be used in the design of future interventions.TRIAL REGISTRATION: This trial is registered as ISRCTN11405239 (date assigned 20 April 2018) at www.controlled-trials.com (accessed 5 September 2022). Version 4.0 of the protocol is available at: https://www.journalslibrary.nihr.ac.uk/ (accessed 5 September 2022).FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (NIHR award ref: 16/31/98) programme and is published in full in
Health Technology Assessment; Vol. 27, No. 32. See the NIHR Funding and Awards website for further award information.
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Impact of remote vital sign monitoring on health outcomes in acute respiratory infection and exacerbation of chronic respiratory conditions:systematic review and meta-analysis
No full textBackground Our aim was to investigate the effectiveness of virtual wards on health outcomes in patients with acute respiratory infection.Methods We searched four electronic databases from January 2000–March 2021 for randomised controlled trials (RCTs). We included studies in people with acute respiratory illness or an acute exacerbation of a chronic respiratory illness, where a patient or carer measured vital signs (oximetry, blood pressure, pulse) for initial diagnosis and/or asynchronous monitoring, in a person living in private housing or a care home. We performed random effects meta-analysis for mortality.Results We reviewed 5834 abstracts, 107 full texts, and judged nine RCTs relevant for inclusion in which sample sizes ranged from 37–389 (total=1627), mean ages between 61 and 77 years, and five judged to be at low risk of bias. Five RCTs had fewer hospital admissions in the intervention (monitoring) group, out of which two studies reported a significant difference. Two studies reported more admissions in the intervention group, with one reporting a significant difference. We were unable to perform a meta-analysis on healthcare utilisation and hospitalisation data due to lack of outcome definition in the primary studies and variable outcome measurements. We judged two studies to be at low risk of bias. The pooled summary risk ratio for mortality was 0.90 (95% CI 0.55 to 1.48).Conclusion The limited literature for remote monitoring of vital signs in acute respiratory illness provides weak evidence that these interventions have a variable impact on hospitalisations and healthcare utilisation, and may reduce mortality
A multi-faceted intervention to improve management of antibiotics for CHIldren presenting to primary care with acute COugh and respiratory tract infection (CHICO): an efficient cluster randomised controlled trial
No full textObjectives: Unnecessary use of antibiotics needlessly contributes to antimicrobial resistance. Our aim was to assess whether an easy-to-use multifaceted intervention for children presenting to primary care with respiratory tract infections (RTI) would reduce antibiotic dispensing, without increasing hospital admissions for RTI.
Design: A two-arm randomised controlled trial clustered by GP practice, using routine outcome data, with qualitative and economic evaluations.
Setting: English GP practices using the EMIS® electronic medical record system.
Participants: Children aged 0-9 years with RTI, before and during the COVID-19 pandemic.
Intervention: Three components: i) elicitation of parental concerns during consultation; ii) a clinician-focussed prognostic algorithm to identify children at very low, normal or elevated 30-day hospitalisation risk accompanied by antibiotic prescribing guidance; and iii) a leaflet for carers including safety-netting advice.
Main outcome measures: Rate of dispensed amoxicillin and macrolide antibiotics (superiority comparison) and hospital admissions for RTI (non-inferiority comparison) for children aged
0-9 years over 12 months (same-age practice list-size as denominator).
Results: Of 310 practices required, 294 (95%) were randomised (144 intervention and 150 controls) representing 5% of all registered 0-9 year-olds in England. Of these, 12 (4%) subsequently withdrew (6 related to the pandemic). Median intervention use per practice was 70 (by a median of 9 clinicians). There was no evidence that antibiotic dispensing in intervention practices (155 items per year, per 1000 children [95% CI: 138 to 174]) differed from control practices (157 items per year, per 1000 children [95% CI: 140 to 176]); rate ratio(RR)=1.011 [95% CI:0.992 to 1.029]; p=0.253). Pre-specified subgroup analyses suggested reduced dispensing in intervention practices with fewer prescribing nurses, in single site (compared with multi-site) practices, and located in areas of lower socioeconomic deprivation; although these analyses were underpowered. Pre-specified sensitivity analysis suggested reduced dispensing amongst older children in the intervention arm (p=0.03). A post-hoc sensitivity analyses suggested there was less dispensing in intervention practices pre-pandemic (RR=0.967 [95% CI:0.946 to 0.989];p=0.003). The rate of hospitalisation for RTI in the intervention practices (13 hospitalisations per 1000 children [95% CI:10 to 18)] was non-inferior compared with control practices (15 hospitalisations per 1000 children [95% CI: 12 to 20]); RR=0.952 [95% CI:0.905 to 1.003].
Conclusions: This multifaceted antibiotic stewardship intervention for children with RTIs did not reduce overall antibiotic dispensing nor increase RTI-related hospital admissions. There were some subgroups and situations (e.g. under non-pandemic conditions) where the intervention slightly reduced prescribing rates but not in a clinically meaningful way
Clinical judgement by primary care physicians for the diagnosis of all‐cause dementia or cognitive impairment in symptomatic people
No full textBackgroundIn primary care, general practitioners (GPs) unavoidably reach a clinical judgement about a patient as part of their encounter with patients, and so clinical judgement can be an important part of the diagnostic evaluation. Typically clinical decision making about what to do next for a patient incorporates clinical judgement about the diagnosis with severity of symptoms and patient factors, such as their ideas and expectations for treatment. When evaluating patients for dementia, many GPs report using their own judgement to evaluate cognition, using information that is immediately available at the point of care, to decide whether someone has or does not have dementia, rather than more formal tests.ObjectivesTo determine the diagnostic accuracy of GPs’ clinical judgement for diagnosing cognitive impairment and dementia in symptomatic people presenting to primary care. To investigate the heterogeneity of test accuracy in the included studies.Search methodsWe searched MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), Web of Science Core Collection (ISI Web of Science), and LILACs (BIREME) on 16 September 2021.Selection criteriaWe selected cross‐sectional and cohort studies from primary care where clinical judgement was determined by a GP either prospectively (after consulting with a patient who has presented to a specific encounter with the doctor) or retrospectively (based on knowledge of the patient and review of the medical notes, but not relating to a specific encounter with the patient). The target conditions were dementia and cognitive impairment (mild cognitive impairment and dementia) and we included studies with any appropriate reference standard such as the Diagnostic and Statistical Manual of Mental Disorders (DSM), International Classification of Diseases (ICD), aetiological definitions, or expert clinical diagnosis.Data collection and analysisTwo review authors screened titles and abstracts for relevant articles and extracted data separately with differences resolved by consensus discussion. We used QUADAS‐2 to evaluate the risk of bias and concerns about applicability in each study using anchoring statements. We performed meta‐analysis using the bivariate method.Main resultsWe identified 18,202 potentially relevant articles, of which 12,427 remained after de‐duplication. We assessed 57 full‐text articles and extracted data on 11 studies (17 papers), of which 10 studies had quantitative data. We included eight studies in the meta‐analysis for the target condition dementia and four studies for the target condition cognitive impairment. Most studies were at low risk of bias as assessed with the QUADAS‐2 tool, except for the flow and timing domain where four studies were at high risk of bias, and the reference standard domain where two studies were at high risk of bias. Most studies had low concern about applicability to the review question in all QUADAS‐2 domains.Average age ranged from 73 years to 83 years (weighted average 77 years). The percentage of female participants in studies ranged from 47% to 100%. The percentage of people with a final diagnosis of dementia was between 2% and 56% across studies (a weighted average of 21%). For the target condition dementia, in individual studies sensitivity ranged from 34% to 91% and specificity ranged from 58% to 99%. In the meta‐analysis for dementia as the target condition, in eight studies in which a total of 826 of 2790 participants had dementia, the summary diagnostic accuracy of clinical judgement of general practitioners was sensitivity 58% (95% confidence interval (CI) 43% to 72%), specificity 89% (95% CI 79% to 95%), positive likelihood ratio 5.3 (95% CI 2.4 to 8.2), and negative likelihood ratio 0.47 (95% CI 0.33 to 0.61).For the target condition cognitive impairment, in individual studies sensitivity ranged from 58% to 97% and specificity ranged from 40% to 88%. The summary diagnostic accuracy of clinical judgement of general practitioners in four studies in which a total of 594 of 1497 participants had cognitive impairment was sensitivity 84% (95% CI 60% to 95%), specificity 73% (95% CI 50% to 88%), positive likelihood ratio 3.1 (95% CI 1.4 to 4.7), and negative likelihood ratio 0.23 (95% CI 0.06 to 0.40).It was impossible to draw firm conclusions in the analysis of heterogeneity because there were small numbers of studies. For specificity we found the data were compatible with studies that used ICD‐10, or applied retrospective judgement, had higher reported specificity compared to studies with DSM definitions or using prospective judgement. In contrast for sensitivity, we found studies that used a prospective index test may have had higher sensitivity than studies that used a retrospective index test.Authors' conclusionsClinical judgement of GPs is more specific than sensitive for the diagnosis of dementia. It would be necessary to use additional tests to confirm the diagnosis for either target condition, or to confirm the absence of the target conditions, but clinical judgement may inform the choice of further testing. Many people who a GP judges as having dementia will have the condition. People with false negative diagnoses are likely to have less severe disease and some could be identified by using more formal testing in people who GPs judge as not having dementia. Some false positives may require similar practical support to those with dementia, but some ‐ such as some people with depression ‐ may suffer delayed intervention for an alternative treatable pathology.</p
Decline in cognition from mid-life improves specificity of mini-mental state examination: diagnostic test accuracy in Caerphilly Prospective Study (CaPS)
No full textBackground: The merit of using baseline cognitive assessments in mid-life to help interpret cross-sectional cognitive tests scores in later life is uncertain.
Objective: Evaluate how accuracy for diagnosing dementia is enhanced by comparing cross-sectional results to a midlife measure.
Method: Cohort study of 2,512 men with repeated measures of Mini Mental State Examination (MMSE) over approximately 10 years. Index test MMSE at threshold of 24 indicating normal, as a cross-sectional measure and in combination with decline in MMSE score from mid-life. Reference standard consensus clinical diagnosis of dementia by two clinicians according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
Results: 1,150 men participated at phase 4 of whom 75 had dementia. A cross-sectional MMSE alone produced a sensitivity of 60% (50% to 70%) and specificity 95% (94% to 97%) with a threshold of ≥ 24 points indicating normal. For lower-scoring men in late life, with cross sectional scores of <22, combining cross-sectional AND a three-point or more decline over time had a sensitivity of 52% (39% to 64%) and specificity 99% (99% to 100%). For higher-scoring men in later life, with cross sectional scores <26 combining cross-sectional OR decline of at least three points had a sensitivity of 98% (92% to 100%) and specificity 38% (32% to 44%).
Conclusion: It may be helpful in practice to formally evaluate cognition in mid-life as a baseline to compare with if problems develop in future, as this may enhance diagnostic accuracy and classification of people in later life
Towards improving diagnosis of memory loss in general practice:TIMeLi diagnostic test accuracy study protocol
No full textBackground People with cognitive problems, and their families, report distress and uncertainty whilst undergoing evaluation for dementia and perceive that traditional diagnostic evaluation in secondary care is insufficiently patient centred. The James Lind Alliance has prioritised research to investigate the role of primary care in supporting a more effective diagnostic pathway, and the topic is also of interest to health commissioners. However, there are very few studies that investigate the accuracy of diagnostic tests for dementia in primary care. Methods We will conduct a prospective diagnostic test accuracy study to evaluate the accuracy of a range of simple tests for diagnosing all-cause-dementia in symptomatic people aged over 70 years who have consulted with their general practitioner (GP). We will invite eligible people to attend a research clinic where they will undergo a range of index tests that a GP could perform in the surgery and also be assessed by a specialist in memory disorders at the same appointment. Participating GPs will request neuroimaging and blood tests and otherwise manage patients in line with their usual clinical practice. The reference standard will be the consensus judgement of three experts (neurologist, psychiatrist and geriatrician) based on information from the specialist assessment, GP records and investigations, but not including items in the index test battery. The target condition will be all-cause dementia but we will also investigate diagnostic accuracy for sub-types where possible. We will use qualitative interviews with patients and focus groups with clinicians to help us understand the acceptability and feasibility of diagnosing dementia in primary care using the tests that we are investigating. Discussion Our results will help clinicians decide on which tests to perform in someone where there is concern about possible dementia and inform commissioning of diagnostic pathways.</p
The range of peripapillary retinal nerve fibre layer and optic disc parameters in children aged up to but not including 18 years of age, as measured by optical coherence tomography:protocol for a systematic review
No full textBackgroundThe parameters of the optic disc and peripapillary retinal nerve fibre layer (pRNFL) in children may vary with disease processes that contribute to visual impairment and blindness and so could be useful as an objective measure in at-risk children. There is no standardised reference for the normal parameters of the optic disc and pRNFL in children; however, there are a large number of small individual studies that have been undertaken to look at these measures.MethodsA systematic review of current literature on the range of pRNFL and optic disc parameters in children aged less than 18 years will be performed. Studies will be considered for review if they report numerical data on optic disc and pRNFL parameters, measured using optical coherence tomography. Outcome measures will include mean pRNFL thickness and cup-disc ratio. The bibliographic databases Medline, CINAHL, EMBASE, Scopus and Web of Science will be systematically searched from 1991. Screening of search results will be conducted by two authors working independently, as will extraction of primary and secondary outcome data. Ten per cent of all other data extraction will be checked by a second author. Results will be compiled and presented in evidence tables. Where possible and appropriate, study-specific estimates will be combined to obtain an overall summary estimate of pRNFL thickness and cup-disc ratio across studies and results will be presented by age of population. Subgroup analyses will be undertaken for children of different ethnicities.DiscussionThis review aims to provide an overview of the parameters of the optic disc and pRNFL in children of different ages in order to identify gaps in knowledge and to improve understanding of what might be considered within/outside the range of normality. The findings will be presented in peer-reviewed journals and will be presented at conferences.Systematic review registrationPROSPERO CRD4201603306
