To assess the accuracy of commercially available pulse oximeters at various price points, and to investigate how long is needed to obtain a reliable measurement. All 75 participants had pulse oximetry with 6 test oximeters and a reference (gold standard) oximeter. Where blood gases were clinically indicated, these results were also recorded. Compared to the reference oximeter, average errors in oxygen saturation ranged from 0.6% to 2.6% overestimation. All devices appeared to require some time to “settle” to an accurate reading, but accuracy at 30 seconds from application was similar to that at 2 minutes. There was no clear association between device cost and accuracy. Fingertip pulse oximeters tended to overestimate oxygen saturation by up to 2.5% on average. We recommend that pulse oximeters are not read immediately after application, but are allowed at least 30 seconds to settle to an accurate reading. Fingertip pulse oximeters are widely used in clinical care, particularly in the primary care and pre-hospital environment, and increasingly for self-monitoring by patients. We found that pulse oximeter accuracy varies for both oxygen saturation and heart rate, with 2.5% overestimation of oxygen saturation on average. Price is not necessarily an indicator of accuracy in pulse oximeters. Accuracy can be improved by waiting at least 30 seconds before recording oxygen saturation. Pulse oximeters are non-invasive fingertip medical devices that measure the amount of oxygen in the blood (“oxygen saturations” or “sats”), which in healthy people should be between 96% and 100%. They also measure heart rate. Some pulse oximeters are available to buy by the public quite cheaply, and their use for home monitoring has become more common during and since the COVID-19 pandemic. We wanted to understand if cheap oximeters are still accurate. We bought 6 different pulse oximeters and tested them on 26 healthy people and 49 patients who were attending a hospital outpatient clinic. We compared the oxygen saturation measurements from the 6 cheap oximeters with measurements from a hospital quality pulse oximeter as a “gold standard”. We compared the heart rate measurements from the pulse oximeters to a measurement of heart rate made by hand by a nurse. We also measured how long it took for the pulse oximeter to give an accurate measurement. We found that the cheap pulse oximeters generally gave an oxygen saturation value that was between 0.6% and 2.6% higher than the hospital pulse oximeter. However, sometimes there was a larger difference of up to 7.4%. The cheap pulse oximeters also generally gave a heart rate that was between 0.8 and 2.7 beats per minute higher than the rate measured by a nurse. After 30 seconds, the pulse oximeter measurements were about as accurate as they were after 2 minutes. We found that very cheap pulse oximeters were just as accurate as less cheap pulse oximeters. Our results suggest that cheap pulse oximeters tend to overestimate oxygen saturations and heart rate, but usually by a small amount which would not make much difference to the decisions a doctor would make. However, sometimes there may be a bigger difference so we would recommend repeating with a different device if there was concern about the patient.

Background:Dexmedetomidine may expedite recovery from acute kidney injury (AKI) in critically ill adults. Methods:This study utilizes data from the fourth edition of the Medical Information Mart for Intensive Care (MIMIC-IV). Adult patients admitted to Beth Israel Deaconess Medical Center in Boston, Massachusetts, between 2008 and 2019 with AKI and who have at least two serum creatinine values recorded in the MIMIC-IV database meet study inclusion criteria. The primary outcome measure is the time (days) from diagnosis of AKI to recovery. Secondary outcome measures are hospital and ICU length of stay (LOS) as well as in-hospital mortality. Results:A total of 1893 patients are included in this study. While 293 patients received dexmedetomidine, 1600 patients did not receive dexmedetomidine. Treatment with dexmedetomidine is associated with a 53.7% (95% CI: 46.8%-59.8%) decrease in the risk of recovery from AKI, on average, and this value is statistically significant (p < 0.001). Sensitivity analysis utilizing Cox regression of dexmedetomidine rate on time to AKI recovery demonstrated the opposite effect, however, with an adjusted HR of 1.42 (95% CI: 1.24-1.63, p value <0.001). Theories for this opposite effect are explored in the Discussion section of the manuscript. For patients who receive dexmedetomidine, hospital and ICU LOS, on average, increase by 18.98% and 32.56%, respectively (p value <0.001). Patients who receive dexmedetomidine have 0.6 times the odds of in-hospital mortality, on average, compared to patients who do not receive dexmedetomidine, which is statistically significant (p value 0.006). Conclusion:Dexmedetomidine may be associated with slower recovery from AKI in critically ill adults. The prolonged hospital and ICU LOS associated with dexmedetomidine may be related to reduced mortality, but these results require additional investigation. These exploratory results warrant further investigation to better understand the clinical implications of dexmedetomidine exposure in the setting of AKI.

Interim analysis is a common methodology in randomised clinical trials but has received less attention in studies of diagnostic test accuracy. In such studies, early termination for futility may be beneficial if early evidence indicates that a diagnostic test is unlikely to achieve a clinically useful level of diagnostic performance, as measured by the sensitivity and specificity. In this paper, we describe relevant practical and analytical considerations when planning and performing interim analysis in diagnostic accuracy studies, focusing on stopping rules for futility. We present an adaptation of the exact group sequential method for diagnostic testing, with R code provided for implementing this method in practice. The method is illustrated using two simulated data sets and data from a published diagnostic accuracy study for point-of-care testing for SARS-CoV-2. The considerations described in this paper can be used to guide decisions as to when an interim analysis in a diagnostic accuracy study is suitable and highlight areas for further methodological development.

Elevated temperature can be the first sign of infection and neutropenic sepsis in patients undergoing chemotherapy or radiotherapy. Most cancer patients are treated as outpatients and are educated to take their temperatures regularly during treatment. Patients who notice a fever or other concerning symptoms at home are advised to contact the hospital triage unit, who use home-measured temperature, along with other clinical information, to decide whether to admit the patient for assessment and treatment. Following concerns from triage nurses at a regional cancer centre that home-measured temperatures were not being accurately reported, the authors carried out a retrospective audit to quantify differences between reported body temperature at home and on arrival at the triage unit. They found that although temperature measurement is correctly used to identify patients needing further assessment, it is often missing when patients call the triage line and/or measured inaccurately. Improvements in temperature measurement, particularly in the home environment, would be likely to optimise patient care in this vulnerable cohort.

Background: The potential of the electronic health record to support safety netting has been recognised and a number of electronic safety-netting (E-SN) tools developed. Aim: To establish the most important features of E-SN tools. Design & setting: User-experience interviews followed by a Delphi study in a primary care setting in the UK. Method: The user-experience interviews were carried out remotely with primary care staff who had trialled the EMIS E-SN toolkit for suspected cancer. An electronic modified Delphi approach was used, with primary care staff involved in safety netting in any capacity, to measure consensus on tool features. Results: Thirteen user-experience interviews were carried out and features of E-SN tools seen as important formed the majority of the features included in the Delphi study. Three rounds of Delphi survey were administered. Sixteen responders (64%) completed all three rounds, and 28 out of 44 (64%) features reached consensus. Primary care staff preferred tools that were general in scope. Conclusion: Primary care staff indicated that tools that were not specific to cancer or any other disease, and had features that promoted their flexible, efficient, and integrated use, were important. However, when the important features were discussed with the patient and public involvement (PPI) group, they expressed disappointment that features they believed would make E-SN tools robust and provide a safety net that is difficult to fall through did not reach consensus. The successful adoption of E-SN tools will rely on an evidence base of their effectiveness. Efforts should be made to assess the impact of these tools on patient outcomes.

Background: Around one million individuals in the UK have heart failure (HF), a chronic disease that causes significant morbidity and mortality. N-terminal pro-B-type natriuretic peptide (NT-proBNP) monitoring could help improve the care of patients with HF in the community. Aim: The aim of this study is to provide evidence to support the routine use of point-of-care (POC) NT-proBNP monitoring in primary care. Design & setting: In this observational cohort study, the Roche Cobas h 232 POC device was used to measure NT-proBNP in 27 patients with HF at 0, 6, and 12 months, with a subset reanalysed in the laboratory for comparison. Method: Data were analysed for within-person and between-person variability and concordance with laboratory readings using Passing–Bablok regression. GPs reported whether POC results impacted clinical decisionmaking, and patients indicated their willingness to participate in long-term cohort studies using the Likert acceptability scale. Results: Within-person variability in POC NT-proBNP over 12 months was 881 pg/mL (95% confidence interval [CI] = 380 to 1382 pg/mL). Between-person variability was 1972 pg/mL (95% CI = 1,525 to 2791 pg/mL). Passing–Bablok regression showed no significant systematic difference between POC and laboratory measurements. Patients indicated a high level of acceptability, and GP decisionmaking was affected for at least one visit in a third of patients. Conclusion: Within-person variability in POC NT-proBNP is around half of between-person variability, so detecting changes could be of use in HF management. High patient acceptability and impact on clinical decisionmaking warrant further investigation in a larger long-term cohort study.

Background Fever is a common symptom of benign childhood illness but a high fever may be a sign of a serious infection. Temperature is often used by parents to check for illness in their children, and the presence of a high temperature can act as a prompt to consult a healthcare professional. It would be helpful for GPs to understand how well parental assessment of the presence of fever correlates with temperature measurement in the clinic in order to incorporate the history of the child’s fever into their clinical assessment. Methods Secondary analysis of a cross-sectional diagnostic method comparison study. Parents were asked whether they thought their child had fever before their temperature was measured by a researcher. Fever was defined as a temperature of 38 °C and higher using either an axillary or tympanic thermometer. Results Of 399 children recruited, 119 (29.8%) were believed by their parents to be febrile at the time of questioning and 23 (6.3%) had a fever as measured by a researcher in the clinic. 23.5% of children with a parental assessment of fever were found to have a fever in the clinic. Less than 1% of children whose parents thought they did not have a fever were found to be febrile in the clinic. Having more than one child did not improve accuracy of parents assessing fever in their child. Conclusions In the GP surgery setting, a child identified as afebrile by their parent is highly likely to be measured as such in the clinic. A child identified as febrile by their parent is less likely to be measured as febrile.

Background The COVID-19 pandemic has profoundly affected UK primary care, and as a result the route to cancer diagnosis for many patients. Aim To explore how the pandemic affected primary care practice, in particular cancer suspicion, referral, and diagnosis, and how this experience evolved as the pandemic progressed. Design and setting Seventeen qualitative interviews were carried out remotely with primary care staff. Method Staff from practices in England that expressed an interest in trialling an electronic safety-netting tool were invited to participate. Remote, semi-structured interviews were conducted from September 2020 to March 2021. Data analysis followed a thematic analysis and mind-mapping approach. Results The first lockdown was described as providing time to make adjustments to allow remote and minimal-contact consultations but caused concerns over undetected cancers. These concerns were realised in summer and autumn 2020 as the participants began to see higher rates of late-stage cancer presentation. During the second and third lockdowns patients seemed more willing to consult. This combined with usual winter pressures, demands of the vaccine programme, and surging levels of COVID-19 meant that the third lockdown was the most difficult. New ways of working were seen as positive when they streamlined services but also unsafe if they prevented GPs from accessing all relevant information and resulted in delayed cancer diagnoses. Conclusion The post-pandemic recovery of cancer care is dependent on the recovery of primary care. The COVID-19 pandemic has highlighted and exacerbated vulnerabilities in primary care but has also provided new ways of working that may help the recovery.

BACKGROUND:Autoinflation balloons are used to treat patients with otitis media with effusion (OME) to help avoid surgery.AIM:To compare the ability of party balloons with Otovent balloons to produce sufficient pressure for a Valsalva manoeuvre.DESIGN & SETTING:Pressure testing was used to determine the number of times each balloon could produce pressures sufficient for a Valsalva manoeuvre. Subsequently, Otovent balloons were compared with spherical party balloons in a pilot clinical trial of 12 healthy adults.METHOD:Each balloon was inflated 20 times and the maximum pressure was recorded. Three balloons of each type were tested to 50 inflations to assess pressures over persistent use.RESULTS:Otovent balloons' mean inflation pressure was 93 mmHg (95% confidence interval [CI] = 89 to 97 mmHg) on first inflation, dropping to 83 mmHg (95% CI = 80 to 86 mmHg) after 20 inflations. Two types of spherical party balloon required mean inflation pressures of 84 mmHg (95% CI = 77 to 90 mmHg) and 108 mmHg (95% CI = 97 to 119 mmHg) on first inflation, dropping to 74 mmHg (95% CI = 68 to 81 mmHg) and 83 mmHg (95% CI = 77 to 88 mmHg) after 20 inflations. In the pilot trial, there was no difference between the ability of Otovent and spherical balloons (χ2 = 0.24, P = 0.89) to produce the sensation of a Valsalva manoeuvre.CONCLUSION:Otovent balloons can be used more than the 20 times quoted by the manufacturer. The two spherical balloons produced similar pressures to Otovent balloons, indicating potentially the same clinical effect. The pilot study suggests a potential use of spherical party balloons instead of Otovent balloons as a cost-efficient treatment.

Background Nearly 40% of parents with children aged 6 to 17 months consult a healthcare professional when their child has a high temperature. Clinical guidelines recommend temperature measurement in these children, but little is known about parents’ experiences of and beliefs about temperature measurement. This study aimed to explore parents’ concerns and beliefs about temperature measurement in children. Methods Semi-structured qualitative interviews were conducted from May 2017 to June 2018 with 21 parents of children aged 4 months to 5.5 years, who were purposively sampled from the METRIC study (a method comparison study comparing non-contact infrared thermometers to axillary and tympanic thermometers in acutely ill children). Data analysis followed a thematic approach. Results Parents described the importance of being able to detect fever, in particular high fevers, and how this then influenced their actions. The concept of “accuracy” was valued by parents but the aspects of performance which were felt to reflect accuracy varied. Parents used numerical values of temperature in four main ways: determining precision of the thermometer on repeat measures, detecting a “bad” fever, as an indication to administer antipyretics, or monitoring response to treatment. Family and social networks, the internet, and medical professionals and resources, were all key sources of advice for parents regarding fever, and guiding thermometer choice. Conclusions Temperature measurement in children has diagnostic value but can either empower, or cause anxiety and practical challenges for parents. This represents an opportunity for both improved communication between parents and healthcare professionals, and technological development, to support parents to manage febrile illness with greater confidence in the home.

Background: Long-term monitoring is important in chronic condition management. Despite considerable costs of monitoring, there is no or poor evidence on how, what and when to monitor. The aim of this study was to improve understanding, methods, evidence base and practice of clinical monitoring in primary care, focusing on two areas: chronic kidney disease and chronic heart failure. Objectives: The research questions were as follows: does the choice of test affect better care while being affordable to the NHS? Can the number of tests used to manage individuals with early-stage kidney disease, and hence the costs, be reduced? Is it possible to monitor heart failure using a simple blood test? Can this be done using a rapid test in a general practitioner consultation? Would changes in the management of these conditions be acceptable to patients and carers? Design: Various study designs were employed, including cohort, feasibility study, Clinical Practice Research Datalink analysis, seven systematic reviews, two qualitative studies, one cost-effectiveness analysis and one cost recommendation. Setting: This study was set in UK primary care. Data sources: Data were collected from study participants and sourced from UK general practice and hospital electronic health records, and worldwide literature. Participants: The participants were NHS patients (Clinical Practice Research Datalink: 4.5 million patients), chronic kidney disease and chronic heart failure patients managed in primary care (including 750 participants in the cohort study) and primary care health professionals. Interventions: The interventions were monitoring with blood and urine tests (for chronic kidney disease) and monitoring with blood tests and weight measurement (for chronic heart failure). Main outcome measures: The main outcomes were the frequency, accuracy, utility, acceptability, costs and cost-effectiveness of monitoring. Results: Chronic kidney disease: serum creatinine testing has increased steadily since 1997, with most results being normal (83% in 2013). Increases in tests of creatinine and proteinuria correspond to their introduction as indicators in the Quality and Outcomes Framework. The Chronic Kidney Disease Epidemiology Collaboration equation had 2.7% greater accuracy (95% confidence interval 1.6% to 3.8%) than the Modification of Diet in Renal Disease equation for estimating glomerular filtration rate. Estimated annual transition rates to the next chronic kidney disease stage are ≈ 2% for people with normal urine albumin, 3–5% for people with microalbuminuria (3–30 mg/mmol) and 3–12% for people with macroalbuminuria (> 30 mg/mmol). Variability in estimated glomerular filtration rate-creatinine leads to misclassification of chronic kidney disease stage in 12–15% of tests in primary care. Glycaemic-control and lipid-modifying drugs are associated with a 6% (95% confidence interval 2% to 10%) and 4% (95% confidence interval 0% to 8%) improvement in renal function, respectively. Neither estimated glomerular filtration rate-creatinine nor estimated glomerular filtration rate-Cystatin C have utility in predicting rate of kidney function change. Patients viewed phrases such as ‘kidney damage’ or ‘kidney failure’ as frightening, and the term ‘chronic’ was misinterpreted as serious. Diagnosis of asymptomatic conditions (chronic kidney disease) was difficult to understand, and primary care professionals often did not use ‘chronic kidney disease’ when managing patients at early stages. General practitioners relied on Clinical Commissioning Group or Quality and Outcomes Framework alerts rather than National Institute for Health and Care Excellence guidance for information. Cost-effectiveness modelling did not demonstrate a tangible benefit of monitoring kidney function to guide preventative treatments, except for individuals with an estimated glomerular filtration rate of 60–90 ml/minute/1.73 m2, aged < 70 years and without cardiovascular disease, where monitoring every 3–4 years to guide cardiovascular prevention may be cost-effective. Chronic heart failure: natriuretic peptide-guided treatment could reduce all-cause mortality by 13% and heart failure admission by 20%. Implementing natriuretic peptide-guided treatment is likely to require predefined protocols, stringent natriuretic peptide targets, relative targets and being located in a specialist heart failure setting. Remote monitoring can reduce all-cause mortality and heart failure hospitalisation, and could improve quality of life. Diagnostic accuracy of point-of-care N-terminal prohormone of B-type natriuretic peptide (sensitivity, 0.99; specificity, 0.60) was better than point-of-care B-type natriuretic peptide (sensitivity, 0.95; specificity, 0.57). Within-person variation estimates for B-type natriuretic peptide and weight were as follows: coefficient of variation, 46% and coefficient of variation, 1.2%, respectively. Point-of-care N-terminal prohormone of B-type natriuretic peptide within-person variability over 12 months was 881 pg/ml (95% confidence interval 380 to 1382 pg/ml), whereas between-person variability was 1972 pg/ml (95% confidence interval 1525 to 2791 pg/ml). For individuals, monitoring provided reassurance; future changes, such as increased testing, would be acceptable. Point-of-care testing in general practice surgeries was perceived positively, reducing waiting time and anxiety. Community heart failure nurses had greater knowledge of National Institute for Health and Care Excellence guidance than general practitioners and practice nurses. Health-care professionals believed that the cost of natriuretic peptide tests in routine monitoring would outweigh potential benefits. The review of cost-effectiveness studies suggests that natriuretic peptide-guided treatment is cost-effective in specialist settings, but with no evidence for its value in primary care settings. Limitations: No randomised controlled trial evidence was generated. The pathways to the benefit of monitoring chronic kidney disease were unclear. Conclusions: It is difficult to ascribe quantifiable benefits to monitoring chronic kidney disease, because monitoring is unlikely to change treatment, especially in chronic kidney disease stages G3 and G4. New approaches to monitoring chronic heart failure, such as point-of-care natriuretic peptide tests in general practice, show promise if high within-test variability can be overcome. Future work: The following future work is recommended: improve general practitioner–patient communication of early-stage renal function decline, and identify strategies to reduce the variability of natriuretic peptide. Study registration: This study is registered as PROSPERO CRD42015017501, CRD42019134922 and CRD42016046902. Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 10. See the NIHR Journals Library website for further project information.

Background: Morton's neuroma is a common condition that routinely presents in podiatric practice. The aim of this study was to systematically synthesize the evidence relating to the effectiveness of a corticosteroid injection for Morton's neuroma. Methods: Studies with a publication date of 1960 or later were eligible, and searches were performed within the Turning Research Into Practice database; the Cochrane Central Register of Controlled Trials; the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register; MEDLINE (Ovid); PubMed; Embase; Cumulative Index to Nursing and Allied Health Literature; and the gray literature. Study selection criteria included randomized and nonrandomized controlled trials where a single corticosteroid injection for Morton's neuroma pain was investigated. The primary outcome was Morton's neuroma pain as measured by any standard validated pain scale. Results: Ten studies involving 695 participants were included. The quality of the studies was considered low and subject to bias. Of the included studies, five compared corticosteroid injection to usual care, one compared corticosteroid injection to local anesthetic alone, one compared ultrasound-guided to non-ultrasound-guided injections, three compared corticosteroid injections to surgery, one compared small to large neuromas, six assessed patient satisfaction, four measured adverse events, one studied return to work, and one examined failure of the corticosteroid injection to improve pain. Overall, these studies identified a moderate short- to medium-term benefit of corticosteroid injections on the primary outcome of pain and a low adverse event rate. Conclusions: A single corticosteroid injection appears to have a beneficial short- to medium-term effect on Morton's neuroma pain. It appears superior to usual care, but its superiority to local anaesthetic alone is questionable, and it is inferior to surgical excision. A very low adverse event rate was noted throughout the studies, indicating the intervention is safe when used for Morton's neuroma. However, the quality of the evidence is low, and these findings may change with further research.

There has been a marked rise in the number of avoidable deaths in health services around the world. At the same time there has been a growing increase in antibiotic resistant so-called "superbugs." We examine here the potential role of body temperature measurement in these adverse trends. Electronic based thermometers have replaced traditional mercury (and other liquid-in-glass type) thermometers for reasons of safety rather than superiority. Electronic thermometers are in general less robust from a measurement perspective than their predecessors. We illustrate the implications of unreliable temperature measurement on the diagnosis and management of disease, including COVID-19, through statistical calculations. Since a return to mercury thermometers is both undesirable and impractical, we call for better governance in the current practice of clinical thermometry to ensure the traceability and long-term accuracy of electronic thermometers and discuss how this could be achieved.

Background Monitoring is the mainstay of chronic kidney disease management in primary care; however, there is little evidence about the best way to do this. Aim To compare the effectiveness of estimated glomerular filtration rate (eGFR) derived from serum creatinine and serum cystatin C to predict renal function decline among those with a recent eGFR of 30–89 ml/min/1.73 m2. Design and setting Observational cohort study in UK primary care. Method Serum creatinine and serum cystatin C were both measured at seven study visits over 2 years in 750 patients aged ≥18 years with an eGFR of 30–89 ml/min/1.73 m2 within the previous year. The primary outcome was change in eGFR derived from serum creatinine or serum cystatin C between 6 and 24 months. Results Average change in eGFR was 0.51 ml/min/1.73 m2/year when estimated by serum creatinine and −2.35 ml/min/1.73 m2/year when estimated by serum cystatin C. The c-statistic for predicting renal decline using serum creatininederived eGFR was 0.495 (95% confidence interval [CI] = 0.471 to 0.519). The equivalent c-statistic using serum cystatin C-derived eGFR was 0.497 (95% CI = 0.468 to 0.525). Similar results were obtained when restricting analyses to those aged ≥75 or <75 years, or with eGFR ≥60 ml/min/1.73 m2. In those with eGFR <60 ml/min/1.73 m2, serum cystatin C-derived eGFR was more predictive than serum creatinine-derived eGFR for future decline in kidney function. Conclusion In the primary analysis neither eGFR estimated from serum creatinine nor from serum cystatin C predicted future change in kidney function, partly due to small changes during 2 years. In some secondary analyses there was a suggestion that serum cystatin C was a more useful biomarker to estimate eGFR, especially in those with a baseline eGFR <60 ml/min/1.73 m2.

Introduction Safety-netting in primary care is the best practice in cancer diagnosis, ensuring that patients are followed up until symptoms are explained or have resolved. Currently, clinicians use haphazard manual solutions. The ubiquitous use of electronic health records provides an opportunity to standardise safety-netting practices. A new electronic safety-netting toolkit has been introduced to provide systematic ways to track and follow up patients. We will evaluate the effectiveness of this toolkit, which is embedded in a major primary care clinical system in England:Egerton Medical Information System(EMIS)-Web. Methods and analysis We will conduct a stepped-wedge cluster RCT in 60 general practices within the RCGP Research and Surveillance Centre (RSC) network. Groups of 10 practices will be randomised into the active phase at 2-monthly intervals over 12 months. All practices will be activated for at least 2 months. The primary outcome is the primary care interval measured as days between the first recorded symptom of cancer (within the year prior to diagnosis) and the subsequent referral to secondary care. Other outcomes include referrals rates and rates of direct access cancer investigation. Analysis of the clustered stepped-wedge design will model associations using a fixed effect for intervention condition of the cluster at each time step, a fixed effect for time and other covariates, and then include a random effect for practice and for patient to account for correlation between observations from the same centre and from the same participant. Ethics and dissemination Ethical approval has been obtained from the North West—Greater Manchester West National Health Service Research Ethics Committee (REC Reference 19/NW/0692). Results will be disseminated in peer-reviewed journals and conferences, and sent to participating practices. They will be published on the University of Oxford Nuffield Department of Primary Care and RCGP RSC websites. Trial registration number ISRCTN15913081; Pre-results .

Background:'Standard Precautions' refers to a system of actions, such as using personal protective equipment or adhering to safe handling of needles, that healthcare workers take to reduce the spread of germs in healthcare...

BACKGROUND:Current options for temperature measurement in children presenting to primary care include either electronic axillary or infrared tympanic thermometers. Non-contact infrared thermometers could reduce both the distress of the child and the risk of cross-infection. OBJECTIVES:The objective of this study was to compare the use of non-contact thermometers with the use of electronic axillary and infrared tympanic thermometers in children presenting to primary care. DESIGN:Method comparison study with a nested qualitative study. SETTING:Primary care in Oxfordshire. PARTICIPANTS:Children aged ≤ 5 years attending with an acute illness. INTERVENTIONS:Two types of non-contact infrared thermometers [i.e. Thermofocus (Tecnimed, Varese, Italy) and Firhealth (Firhealth, Shenzhen, China)] were compared with an electronic axillary thermometer and an infrared tympanic thermometer. MAIN OUTCOME MEASURES:The primary outcome was agreement between the Thermofocus non-contact infrared thermometer and the axillary thermometer. Secondary outcomes included agreement between all other sets of thermometers, diagnostic accuracy for detecting fever, parental and child ratings of acceptability and discomfort, and themes arising from our qualitative interviews with parents. RESULTS:A total of 401 children (203 boys) were recruited, with a median age of 1.6 years (interquartile range 0.79-3.38 years). The readings of the Thermofocus non-contact infrared thermometer differed from those of the axillary thermometer by -0.14 °C (95% confidence interval -0.21 to -0.06 °C) on average with the lower limit of agreement being -1.57 °C (95% confidence interval -1.69 to -1.44 °C) and the upper limit being 1.29 °C (95% confidence interval 1.16 to 1.42 °C). The readings of the Firhealth non-contact infrared thermometer differed from those of the axillary thermometer by -0.16 °C (95% confidence interval -0.23 to -0.09 °C) on average, with the lower limit of agreement being -1.54 °C (95% confidence interval -1.66 to -1.41 °C) and the upper limit being 1.22 °C (95% confidence interval 1.10 to 1.34 °C). The difference between the first and second readings of the Thermofocus was -0.04 °C (95% confidence interval -0.07 to -0.01 °C); the lower limit was -0.56 °C (95% confidence interval -0.60 to -0.51 °C) and the upper limit was 0.47 °C (95% confidence interval 0.43 to 0.52 °C). The difference between the first and second readings of the Firhealth thermometer was 0.01 °C (95% confidence interval -0.02 to 0.04 °C); the lower limit was -0.60 °C (95% confidence interval -0.65 to -0.54 °C) and the upper limit was 0.61 °C (95% confidence interval 0.56 to 0.67 °C). Sensitivity and specificity for the Thermofocus non-contact infrared thermometer were 66.7% (95% confidence interval 38.4% to 88.2%) and 98.0% (95% confidence interval 96.0% to 99.2%), respectively. For the Firhealth non-contact infrared thermometer, sensitivity was 12.5% (95% confidence interval 1.6% to 38.3%) and specificity was 99.4% (95% confidence interval 98.0% to 99.9%). The majority of parents found all methods to be acceptable, although discomfort ratings were highest for the axillary thermometer. The non-contact thermometers required fewer readings than the comparator thermometers. LIMITATIONS:A method comparison study does not compare new methods against a reference standard, which in this case would be central thermometry requiring the placement of a central line, which is not feasible or acceptable in primary care. Electronic axillary and infrared tympanic thermometers have been found to have moderate agreement themselves with central temperature measurements. CONCLUSIONS:The 95% limits of agreement are > 1 °C for both non-contact infrared thermometers compared with electronic axillary and infrared tympanic thermometers, which could affect clinical decision-making. Sensitivity for fever was low to moderate for both non-contact thermometers. FUTURE WORK:Better methods for peripheral temperature measurement that agree well with central thermometry are needed. TRIAL REGISTRATION:Current Controlled Trials ISRCTN15413321. FUNDING:This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 53. See the NIHR Journals Library website for further project information.

Abstract Background Current reference ranges for blood pressure and heart rate throughout pregnancy have a poor evidence base. Methods This is a systematic review and meta-analysis. We included studies measuring blood pressure or heart rate from healthy pregnant women within defined gestational periods of 16 weeks or less. We analysed systolic blood pressure, diastolic blood pressure and heart rate by gestational age. We assessed effects of measurement year and method. Results We included 39 studies undertaken in 1967–2017, containing 124,349 systolic measurements from 36,239 women, 124,291 diastolic measurements from 36,181 women and 10,948 heart rate measurements from 8317 women. Mean (95% CI) systolic blood pressure was lowest at 10 weeks gestation, 110.4 (108.5, 112.3) mmHg, rising to 116.0 (113.6, 118.4) mmHg at 40 weeks, mean (95% CI) change 5.6 (4.0, 7.2) mmHg. Mean (95% CI) diastolic blood pressure was lowest at 21 weeks gestation, 65.9 (64.2, 67.7) mmHg; rising to 72.8 (71.0, 74.6) mmHg at 40 weeks, mean (95% CI) change 6.9 (6.2, 7.5) mmHg. Mean (95% CI) heart rate rose from 79.3 (75.5, 83.1) beats/min at 10 weeks to 86.9 (82.2, 91.6) beats/min at 40 weeks gestation, mean (95% CI) change 7.6 (1.8, 13.4) beats/min. Studies using manual measurement reported higher diastolic blood pressures than studies using automated measurement, mean (95 CI) difference 4.9 (0.8, 8.9) mmHg. Diastolic blood pressure increased by 0.26 (95% CI 0.10–0.43) mmHg/year. Including only higher-quality studies had little effect on findings, with heterogeneity remaining high (I2 statistic > 50%). Conclusions Significant gestational blood pressure and heart rate changes occur that should be taken into account when assessing pregnant women. Commonly taught substantial decreases in blood pressure mid-pregnancy were not seen and heart rate increases were lower than previously thought. Manual and automated blood pressure measurement cannot be used interchangeably. Increases in diastolic blood pressure over the last half-century and differences between published studies show contemporary data are required to define current normal ranges. Study registration PROSPERO CRD42014009673