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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
Probiotics to reduce antibiotic administration in care home residents aged 65 years and older: the PRINCESS RCT
BackgroundCare homes are an increasingly important sector of care. Care home residents are particularly vulnerable to infections and are often prescribed antibiotics, driving antibiotic resistance. Probiotics may be a cheap and safe way to reduce antibiotic use. Efficacy and possible mechanisms of action are yet to be rigorously evaluated in this group.ObjectiveThe objective was to evaluate efficacy and explore mechanisms of action of a daily oral probiotic combination in reducing antibiotic use and infections in care home residents.DesignThis was a multicentre, parallel, individually randomised, placebo-controlled, double-blind trial, with qualitative evaluation and mechanistic studies.SettingA total of 310 care home residents were randomised from 23 UK care homes (from December 2016 to May 2018).ParticipantsThe participants were care home residents aged ≥ 65 years who were willing and able to give informed consent or, if they lacked capacity to consent, had a consultee to advise about participation on their behalf.InterventionA daily capsule containing an oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12 (n = 155) or matched placebo (n = 155) for up to 1 year.Main outcome measuresThe primary outcome was cumulative systemic antibiotic administration days for all-cause infections. Secondary outcomes included incidence and duration of infections, antibiotic-associated diarrhoea, quality of life, hospitalisations and the detection of resistant Enterobacterales cultured from stool samples (not exclusively).MethodsParticipants were randomised (1 : 1) to receive capsules containing probiotic or matched placebo. Minimisation was implemented for recruiting care home and care home resident sex. Care home residents were followed up for 12 months with a review by a research nurse at 3 months and at 6–12 months post randomisation. Care home residents, consultees, care home staff and all members of the trial team, including assessors and statisticians, were blinded to group allocation.ResultsCare home residents who were randomised to probiotic had a mean 12.9 cumulative systemic antibiotic administration days (standard error 1.49 days) (n = 152) and care home residents randomised to placebo had a mean 12.0 cumulative systemic antibiotic administration days (standard error 1.50 days) (n = 153) (adjusted incidence rate ratio = 1.13, 95% confidence interval 0.79 to 1.63; p = 0.495). There was no evidence of any beneficial effects on incidence and duration of infections, antibiotic-associated diarrhoea, quality of life, hospitalisations, the detection of resistant Enterobacterales cultured from stool samples or other secondary outcomes. There was no evidence that this probiotic combination improved blood immune cell numbers, subtypes or responses to seasonal influenza vaccination.ConclusionsCare home residents did not benefit from daily consumption of a combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12 to reduce antibiotic consumption.LimitationsLimitations included the following: truncated follow-up of some participants; higher than expected probiotics in stool samples at baseline; fewer events than expected meant that study power may have been lower than anticipated; standard infection-related definitions were not used; and findings are not necessarily generalisable because effects may be strain specific and could vary according to patient population.Future workFuture work could involve further rigorous efficacy, mechanisms and effectiveness trials of other probiotics in other population groups and settings regarding antibiotic use and susceptibility to and recovery from infections, in which potential harms should be carefully studied.Trial registrationCurrent Controlled Trials ISRCTN16392920.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.
Relationships Between Age, Frailty, Length of Care Home Residence and Biomarkers of Immunity and Inflammation in Older Care Home Residents in the United Kingdom.
Aging is associated with changes to the immune system, collectively termed immunosenescence and inflammageing. However, the relationships among age, frailty, and immune parameters in older people resident in care homes are not well described. We assessed immune and inflammatory parameters in 184 United Kingdom care home residents aged over 65 years and how they relate to age, frailty index, and length of care home residence. Linear regression was used to identify the independent contribution of age, frailty, and length of care home residence to the various immune parameters as dependent variables. Participants had a mean age (±SD) of 85.3 ± 7.5 years, had been residing in the care home for a mean (±SD) of 1.9 ± 2.2 years at the time of study commencement, and 40.7% were severely frail. Length of care home residence and frailty index were correlated but age and frailty index and age and length of care home residence were not significantly correlated. All components of the full blood count, apart from total lymphocytes, were within the reference range; 31% of participants had blood lymphocyte numbers below the lower value of the reference range. Among the components of the full blood count, platelet numbers were positively associated with frailty index. Amongst plasma inflammatory markers, C-reactive protein (CRP), interleukin-1 receptor antagonist (IL-1ra), soluble E-selectin and interferon gamma-induced protein 10 (IP-10) were positively associated with frailty. Plasma soluble vascular cell adhesion molecule 1 (sVCAM-1), IP-10 and tumor necrosis factor receptor II (TNFRII) were positively associated with age. Plasma monocyte chemoattractant protein 1 was positively associated with length of care home residence. Frailty was an independent predictor of platelet numbers, plasma CRP, IL-1ra, IP-10, and sE-selectin. Age was an independent predictor of activated monocytes and plasma IP-10, TNFRII and sVCAM-1. Length of care home residence was an independent predictor of plasma MCP-1. This study concludes that there are independent links between increased frailty and inflammation and between increased age and inflammation amongst older people resident in care homes in the United Kingdom. Since, inflammation is known to contribute to morbidity and mortality in older people, the causes and consequences of inflammation in this population should be further explored.
UMBRELLA protocol: systematic reviews of multivariable biomarker prognostic models developed to predict clinical outcomes in patients with heart failure.
BACKGROUND: Heart failure (HF) is a chronic and common condition with a rising prevalence, especially in the elderly. Morbidity and mortality rates in people with HF are similar to those with common forms of cancer. Clinical guidelines highlight the need for more detailed prognostic information to optimise treatment and care planning for people with HF. Besides proven prognostic biomarkers and numerous newly developed prognostic models for HF clinical outcomes, no risk stratification models have been adequately established. Through a number of linked systematic reviews, we aim to assess the quality of the existing models with biomarkers in HF and summarise the evidence they present. METHODS: We will search MEDLINE, EMBASE, Web of Science Core Collection, and the prognostic studies database maintained by the Cochrane Prognosis Methods Group combining sensitive published search filters, with no language restriction, from 1990 onwards. Independent pairs of reviewers will screen and extract data. Eligible studies will be those developing, validating, or updating any prognostic model with biomarkers for clinical outcomes in adults with any type of HF. Data will be extracted using a piloted form that combines published good practice guidelines for critical appraisal, data extraction, and risk of bias assessment of prediction modelling studies. Missing information on predictive performance measures will be sought by contacting authors or estimated from available information when possible. If sufficient high quality and homogeneous data are available, we will meta-analyse the predictive performance of identified models. Sources of between-study heterogeneity will be explored through meta-regression using pre-defined study-level covariates. Results will be reported narratively if study quality is deemed to be low or if the between-study heterogeneity is high. Sensitivity analyses for risk of bias impact will be performed. DISCUSSION: This project aims to appraise and summarise the methodological conduct and predictive performance of existing clinically homogeneous HF prognostic models in separate systematic reviews.Registration: PROSPERO registration number CRD42019086990.
Long-term effects of functional appliances in treated versus untreated patients with Class II malocclusion: A systematic review and meta-analysis
Objective To assess the cephalometric skeletal and soft-tissue of functional appliances in treated versus untreated Class II subjects in the long-term (primarily at the end of growth, secondarily at least 3 years after retention). Search methods Unrestricted electronic search of 24 databases and additional manual searches up to March 2018. Selection criteria Randomised and non-randomised controlled trials reporting on cephalometric skeletal and soft-tissue measurements of Class II patients (aged 16 years or under) treated with functional appliances, worn alone or in combination with multi-bracket therapy, compared to untreated Class II subjects. Data collection and analysis Mean differences (MDs) and 95% confidence intervals (95% CIs) were calculated with the random-effects model. Data were analysed at 2 primary time points (above 18 years of age, at the end of growth according to the Cervical Vertebral Maturation method) and a secondary time point (at least 3 years after retention). The risk of bias and quality of evidence were assessed according to the ROBINS tool and GRADE system, respectively. Results Eight non-randomised studies published in 12 papers were included. Functional appliances produced a significant improvement of the maxillo-mandibular relationship, at almost all time points (Wits appraisal at the end of growth, MD -3.52 mm, 95% CI -5.11 to -1.93, P < 0.0001). The greatest increase in mandibular length was recorded in patients aged 18 years and above (Co-Gn, MD 3.20 mm, 95% CI 1.32 to 5.08, P = 0.0009), although the improvement of the mandibular projection was negligible or not significant. The quality of evidence was ‘very low’ for most of the outcomes at both primary time points. Conclusions Functional appliances may be effective in correcting skeletal Class II malocclusion in the long-term, however the quality of the evidence was very low and the clinical significance was limited.
Effect of oil pulling in promoting oro dental hygiene: A systematic review of randomized clinical trials
© 2016. Aim: To critically appraise and evaluate the evidence from randomized clinical trials (RCTs) examining the effectiveness of oil pulling on oro dental hygiene. Methods: We conducted electronic searches in Medline, Embase, Amed, The Cochrane Library and Cinahl databases from inception to February 2015, and assessed reporting quality using the Cochrane risk of bias criteria. We included RCTs that compared oil pulling using conventional cooking oils with a control intervention. Our primary outcomes were measures of oro dental hygiene using validated scales. Results: Electronic searches yielded 26 eligible studies, of which five RCTs comprising a total of 160 participants were included. The studies varied in reporting quality, lasted between 10 and 45 days, and compared oil pulling with chlorhexidine, placebo or routine dental hygiene practice. Three studies reported no significant differences in post intervention plaque index scores between oil pulling and control groups (Chlorhexidine mouthwash +/- Placebo): p = 0.28, 0.94, and 0.38, respectively. Two studies reported no significant difference in post-intervention modified gingival index score between oil pulling and Chlorhexidine mouthwash groups (p = 0.32 and 0.64). Conclusion: The limited evidence to date from clinical trials suggests that oil pulling may have beneficial effects on oro dental hygiene as seen for the short period of time investigated. Given that this is a potentially cost-effective intervention, this practice might be of particular benefit. Future clinical trials should be more rigorous and better reported.
Cranberry extract for symptoms of acute, uncomplicated urinary tract infection: A systematic review
© 2020 by the authors. Licensee MDPI, Basel, Switzerland. Background: Effective alternatives to antibiotics for alleviating symptoms of acute infections may be appealing to patients and enhance antimicrobial stewardship. Cranberry-based products are already in wide use for symptoms of acute urinary tract infection (UTI). The aim of this review was to identify and critically appraise the supporting evidence. Methods: The protocol was regis-tered on PROSPERO. Searches were conducted of Medline, Embase, Amed, Cinahl, The Cochrane library, Clinicaltrials.gov and WHO International Clinical Trials Registry Platform. We included randomised clinical trials (RCTs) and non-randomised studies evaluating the effect of cranberry extract in the management of acute, uncomplicated UTI on symptoms, antibiotic use, microbiological assessment, biochemical assessment and adverse events. Study risk of bias assessments were made using Cochrane criteria. Results: We included three RCTs (n = 688) judged to be at moderate risk of bias. One RCT (n = 309) found that advice to consume cranberry juice had no statistically significant effect on UTI frequency symptoms (mean difference (MD) −0.01 (95% CI: −0.37 to 0.34), p = 0.94)), on UTI symptoms of feeling unwell (MD 0.02 (95% CI: −0.36 to 0.39), p = 0.93)) or on antibiotic use (odds ratio 1.27 (95% CI: 0.47 to 3.43), p = 0.64), when compared with promoting drinking water. One RCT (n = 319) found no symptomatic benefit from combining cranberry juice with immediate antibiotics for an acute UTI, compared with placebo juice combined with immediate antibiotics. In one RCT (n = 60), consumption of cranberry extract capsules was associated with a within-group improvement in urinary symptoms and Escherichia coli load at day 10 compared with baseline (p < 0.01), which was not found in untreated controls (p = 0.72). Two RCTs were under-powered to detect differences between groups for outcomes of interest. There were no serious adverse effects associated with cranberry consumption. Conclusion: The current evidence base for or against the use of cranberry extract in the management of acute, uncomplicated UTIs is inadequate; rigorous trials are needed.
Overview of systematic reviews assessing the evidence for shorter versus longer duration antibiotic treatment for bacterial infections in secondary care
© 2018 Onakpoya et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Our objective was to assess the clinical effectiveness of shorter versus longer duration antibiotics for treatment of bacterial infections in adults and children in secondary care settings, using the evidence from published systematic reviews. We conducted electronic searches in MEDLINE, Embase, Cochrane, and Cinahl. Our primary outcome was clinical resolution. The quality of included reviews was assessed using the AMSTAR criteria, and the quality of the evidence was rated using the GRADE criteria. We included 6 systematic reviews (n = 3,162). Four reviews were rated high quality, and two of moderate quality. In adults, there was no difference between shorter versus longer duration in clinical resolution rates for peritonitis (RR 1.03, 95% CI 0.98 to 1.09, I2 = 0%), ventilator-associated pneumonia (RR 0.93; 95% CI 0.81 to 1.08, I2 = 24%), or acute pyelonephritis and septic UTI (clinical failure: RR 1.00, 95% CI 0.46 to 2.18). The quality of the evidence was very low to moderate. In children, there was no difference in clinical resolution rates for pneumonia (RR 0.98, 95% CI 0.91 to 1.04, I2 = 48%), pyelonephritis (RR 0.95, 95% CI 0.88 to 1.04) and confirmed bacterial meningitis (RR 1.02, 95% CI 0.93 to 1.11, I2 = 0%). The quality of the evidence was low to moderate. In conclusion, there is currently a limited body of evidence to clearly assess the clinical benefits of shorter versus longer duration antibiotics in secondary care. High quality trials assessing strategies to shorten antibiotic treatment duration for bacterial infections in secondary care settings should now be a priority.
Biomarkers for diagnosing serious bacterial infections in older outpatients: A systematic review
© 2019 The Author(s). Background: The value of biomarkers for diagnosing bacterial infections in older outpatients is uncertain and limited official guidance exists for clinicians in this area. The aim of this review is to critically appraise and evaluate biomarkers for diagnosing bacterial infections in older adults (aged 65 years and above). Methods: We searched Medline, Embase, Web of Science and the Cochrane Library, from inception to January 2018. We included studies assessing the diagnostic accuracy of blood, urinary, and salivary biomarkers in diagnosing bacterial infections in older adults. The QUADAS-2 tool was used to assess study quality. Results: We identified 11 eligible studies of moderate quality (11,034 participants) including 51 biomarkers at varying thresholds for diagnosing bacterial infections. An elevated Procalcitonin (≥ 0.2 ng/mL) may help diagnose bacteraemia in older adults [+ve LR range 1.50 to 2.60]. A CRP ≥ 50 mg/L only raises the probability of bacteraemia by 5%. A positive urine dipstick aids diagnosis of UTI (+ve LR range 1.23 to 54.90), and absence helps rule out UTI (-ve LR range 0.06 to 0.46). An elevated white blood cell count is unhelpful in diagnosing intra-abdominal infections (+ve LR range 0.75 to 2.62), but may aid differentiation of bacterial infection from other acute illness (+ve LR range 2.14 to 7.12). Conclusions: The limited available evidence suggests that many diagnostic tests useful in younger patients, do not help to diagnose bacterial infections in older adults. Further evidence from high quality studies is urgently needed to guide clinical practice. Until then, symptoms and signs remain the mainstay of diagnosis in community based populations.
Self-sampling to identify pathogens and inflammatory markers in patients with acute sore throat: Feasibility study
Introduction: Sore throat is a common reason for overuse of antibiotics. The value of inflammatory or biomarkers in throat swab or saliva samples in predicting benefit from antibiotics is unknown. Methods: We used the ‘person-based approach’ to develop an online tool to support self-swabbing and recruited adults and children with sore throats through participating general practices and social media. Participants took bacterial and viral swabs and a saliva sponge swab and passive drool sample. Bacterial swabs were cultured for streptococcus (Group A, B, C, F and G). The viral swab and saliva samples were tested using a routine respiratory panel PCR and Covid-19 PCR testing. We used remaining viral swab and saliva sample volume for biomarker analysis using a panel of 13 biomarkers. Results: We recruited 11 asymptomatic participants and 45 symptomatic participants. From 45 symptomatic participants, bacterial throat swab, viral throat swab, saliva sponge and saliva drool samples were returned by 41/45 (91.1%), 43/45 (95.6%), 43/45 (95.6%) and 43/45 (95.6%) participants respectively. Three saliva sponge and 6 saliva drool samples were of insufficient quantity. Two adult participants had positive bacterial swabs. Six participants had a virus detected from at least one sample (swab or saliva). All of the biomarkers assessed were detectable from all samples where there was sufficient volume for testing. For most biomarkers we found higher concentrations in the saliva samples. Due to low numbers, we were not able to compare biomarker concentrations in those who did and did not have a bacterial pathogen detected. We found no evidence of a difference between biomarker concentrations between the symptomatic and asymptomatic participants but the distributions were wide. Conclusions: We have demonstrated that it is feasible for patients with sore throat to self-swab and provide saliva samples for pathogen and biomarker analysis. Typical bacterial and viral pathogens were detected but at low prevalence rates. Further work is needed to determine if measuring biomarkers using oropharyngeal samples can help to differentiate between viral and bacterial pathogens in patients classified as medium or high risk using clinical scores, in order to better guide antibiotic prescribing and reduce inappropriate prescriptions.
Agreement between patient's description of abdominal symptoms of possible upper gastrointestinal cancer and general practitioner consultation notes: a qualitative analysis of video-recorded UK primary care consultation data
INTRODUCTION: Abdominal symptoms are common in primary care but infrequently might be due to an upper gastrointestinal (UGI) cancer. Patients' descriptions may differ from medical terminology used by general practitioners (GPs). This may affect how information about abdominal symptoms possibly due to an UGI cancer are documented, creating potential missed opportunities for timely investigation. OBJECTIVES: To explore how abdominal symptoms are communicated during primary care consultations, and identify characteristics of patients' descriptions that underpin variation in the accuracy and completeness with which they are documented in medical records. METHODS AND ANALYSIS: Primary care consultation video recordings, transcripts and medical records from an existing dataset were screened for adults reporting abdominal symptoms. We conducted a qualitative content analysis to capture alignments (medical record entries matching patient verbal and non-verbal descriptions) and misalignments (symptom information omitted or differing from patient descriptions). Categories were informed by the Calgary-Cambridge guide's 'gathering information' domains and patterns in descriptions explored. RESULTS: Our sample included 28 consultations (28 patients with 18 GPs): 10 categories of different clinical features of abdominal symptoms were discussed. The information GPs documented about these features commonly did not match what patients described, with misalignments more common than alignments (67 vs 43 instances, respectively). Misalignments often featured patients using vague descriptors, figurative speech, lengthy explanations and broad hand gestures. Alignments were characterised by patients using well-defined terms, succinct descriptions and precise gestures for symptoms with an exact location. Abdominal sensations reported as 'pain' were almost always documented compared with expressions of 'discomfort'. CONCLUSIONS: Abdominal symptoms that are well defined or communicated as 'pain' may be more salient to GPs than those expressed vaguely or as 'discomfort'. Variable documentation of abdominal symptoms in medical records may have implications for the development of clinical decision support systems and decisions to investigate possible UGI cancer.
Talking delicately: Providing opportunistic weight loss advice to people living with obesity.
Obesity is a major worldwide public health problem. Clinicians are asked to communicate public health messages, including encouraging and supporting weight loss, during consultations with patients living with obesity. However, research shows that talking about weight with patients rarely happens and both parties find it difficult to initiate. Current guidelines on how to have such conversations do not include evidence-based examples of what to say, when to say it and how to avoid causing offence (a key concern for clinicians). To address this gap, we examined 237 audio recorded consultations between clinicians and patients living with obesity in the UK in which weight was discussed opportunistically. Conversation analysis revealed that framing advice as depersonalised generic information was one strategy clinicians used when initiating discussions. This contrasted to clinicians who made advice clearly relevant and personalised to the patient by first appraising their weight. However not all personalised forms of advice worked equally well. Clinicians who spoke delicately when personalising the discussion avoided the types of patient resistance that we found when clinicians were less delicate. More delicate approaches included forecasting upcoming discussion of weight along with delicacy markers in talk (e.g. strategic use of hesitation). Our findings suggest that clinicians should not avoid talking about a patient's weight, but should speak delicately to help maintain good relationships with patients. The findings also demonstrate the need to examine communication practices to develop better and specific guidance for clinicians. Data are in British English.
Discrepancies between two long-term dietary datasets in the United Kingdom (UK)
Background: Studying dietary trends can help monitor progress towards healthier and more sustainable diets but longitudinal data are often confounded by lack of standardized methods. Two main data sources are used for longitudinal analysis of diets: food balance sheets on food supply (FBS) and household budget surveys on food purchased (HBS). Methods: We used UK longitudinal dietary data on food supply, provided by the Food and Agriculture Organisation (FAO) (FAO-FBS, 1961-2018), and food purchases, provided by the Department for Environment, Food and Rural Affairs (Defra) (Defra-HBS, 1942-2018). We assessed how trends in dietary change per capita compared between FAO-FBS and Defra-HBS for calories, meat and fish, nuts and pulses, and dairy, and how disparities have changed over time. Results: Estimates made by FAO-FBS were significantly higher (p<0.001) than Defra-HBS for calorie intake and all food types, except nuts and pulses which were significantly lower (p<0.001). These differences are partly due to inclusion of retail waste in FAO-FBS data and under-reporting in Defra- HBS data. The disparities between the two datasets increased over time for calories, meat and dairy; did not change for fish; and decreased for nuts and pulses. Between 1961 and 2018, both FAO-FBS and Defra-FBS showed an increase in meat intake (+23.4% and +1.4%, respectively) and a decrease in fish (-7.1% and -3.2%, respectively). Temporal trends did not agree between the two datasets for dairy, calories, and nuts and pulses. Conclusions: Our finding raises questions over the robustness of both data sources for monitoring UK dietary change, especially when used for evidence-based decision making around health, climate change and sustainability.