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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.
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Temperatura Corporal , Termómetros , Niño , Humanos , Padres , Investigación Cualitativa , TemperaturaRESUMEN
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.
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Presión Sanguínea/fisiología , Frecuencia Cardíaca/fisiología , Embarazo/fisiología , Adulto , Femenino , Edad Gestacional , Humanos , Valores de ReferenciaRESUMEN
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.
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OBJECTIVE: To evaluate the utilisation of paper-based track and trigger (T&T) charts in a UK emergency department (ED). METHODS: A single-centre prospective observational cohort study was conducted in the ED of a medium-sized teaching hospital. Charted vital-sign data were collected from adults attending the resuscitation room, majors or observation ward. These data were examined in parallel with clinical notes to identify 'escalation' events. For each set of vital signs, the authors calculated the T&T score retrospectively. RESULTS: Data from 472 patient episodes (2965 sets of vital signs) were examined. 85.8% of patients had at least one full set of observations (CEM standard) and 60.6% had at least one T&T score documented. However, only 34.5% of observation sets had a corresponding T&T score. 20.6% of T&T score totals (1024) were incorrect, potentially preventing a 'trigger' from being recognised. 204 patient episodes had at least one recorded escalation. Physiological escalations were associated with vital-sign scores that met the triggering thresholds (98/104), while patients who had non-physiological escalations or no escalations were more likely to have scores below the triggering thresholds (88/100). Only 26.9% of physiological escalations were associated with a documented T&T score above the triggering threshold. Retrospective completion of the charts increased that figure to 94.2%. CONCLUSION: T&T in the ED is challenged by poor completion rates and numerical errors made during score calculation. However the potential for recognition of a deteriorating patient should not be ignored. The future work of the authors intends to evaluate an electronic system for automatically calculating T&T scores within the ED environment.
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Documentación/métodos , Servicio de Urgencia en Hospital/organización & administración , Triaje/métodos , Signos Vitales , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Observación , Estudios Prospectivos , Reino UnidoRESUMEN
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.
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BACKGROUND: Although heart rate and respiratory rate in children are measured routinely in acute settings, current reference ranges are not based on evidence. We aimed to derive new centile charts for these vital signs and to compare these centiles with existing international ranges. METHODS: We searched Medline, Embase, CINAHL, and reference lists for studies that reported heart rate or respiratory rate of healthy children between birth and 18 years of age. We used non-parametric kernel regression to create centile charts for heart rate and respiratory rate in relation to age. We compared existing reference ranges with those derived from our centile charts. FINDINGS: We identified 69 studies with heart rate data for 143,346 children and respiratory rate data for 3881 children. Our centile charts show decline in respiratory rate from birth to early adolescence, with the steepest fall apparent in infants under 2 years of age; decreasing from a median of 44 breaths per min at birth to 26 breaths per min at 2 years. Heart rate shows a small peak at age 1 month. Median heart rate increases from 127 beats per min at birth to a maximum of 145 beats per min at about 1 month, before decreasing to 113 beats per min by 2 years of age. Comparison of our centile charts with existing published reference ranges for heart rate and respiratory rate show striking disagreement, with limits from published ranges frequently exceeding the 99th and 1st centiles, or crossing the median. INTERPRETATION: Our evidence-based centile charts for children from birth to 18 years should help clinicians to update clinical and resuscitation guidelines. FUNDING: National Institute for Health Research, Engineering and Physical Sciences Research Council.
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Frecuencia Cardíaca/fisiología , Frecuencia Respiratoria/fisiología , Adolescente , Apoyo Vital Cardíaco Avanzado , Niño , Preescolar , Humanos , Lactante , Recién Nacido , Guías de Práctica Clínica como Asunto , Valores de ReferenciaRESUMEN
BACKGROUND: Large artery stiffening and wave reflections are independent predictors of adverse events. To date, their assessment has been limited to specialised techniques and settings. A new, more practical method allowing assessment of central blood pressure from waveforms recorded using a conventional automated oscillometric monitor has recently been validated in laboratory settings. However, the feasibility of this method in a community based setting has not been assessed. METHODS: One-off peripheral and central haemodynamic (systolic and diastolic blood pressure (BP) and pulse pressure) and wave reflection parameters (augmentation pressure (AP) and index, AIx) were obtained from 1,903 volunteers in an Austrian community setting using a transfer-function like method (ARCSolver algorithm) and from waveforms recorded with a regular oscillometric cuff. We assessed these parameters for known differences and associations according to gender and age deciles from <30 years to ≥80 years in the whole population and a subset with a systolic BP < 140 mmHg. RESULTS: We obtained 1,793 measures of peripheral and central BP, PP and augmentation parameters. Age and gender associations with central haemodynamic and augmentation parameters reflected those previously established from reference standard non-invasive techniques under specialised settings. Findings were the same for patients with a systolic BP below 140 mmHg (i.e. normotensive). Lower values for AIx in the current study are possibly due to differences in sampling rates, detection frequency and/or averaging procedures and to lower numbers of volunteers in younger age groups. CONCLUSION: A novel transfer-function like algorithm, using brachial cuff-based waveform recordings, provides robust and feasible estimates of central systolic pressure and augmentation in community-based settings.
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Determinación de la Presión Sanguínea , Arteria Braquial/fisiopatología , Enfermedades Cardiovasculares/diagnóstico , Servicios de Salud Comunitaria , Hemodinámica , Análisis de la Onda del Pulso , Adulto , Distribución por Edad , Anciano , Anciano de 80 o más Años , Algoritmos , Análisis de Varianza , Austria , Presión Sanguínea , Determinación de la Presión Sanguínea/métodos , Determinación de la Presión Sanguínea/normas , Enfermedades Cardiovasculares/fisiopatología , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Análisis de la Onda del Pulso/métodos , Análisis de la Onda del Pulso/normas , Valores de Referencia , Reproducibilidad de los Resultados , Distribución por Sexo , Rigidez VascularRESUMEN
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.
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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.
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Fiebre , Termómetros , Niño , Estudios Transversales , Fiebre/diagnóstico , Humanos , Padres , Atención Primaria de SaludRESUMEN
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.
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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.
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Neuroma de Morton , Neuroma , Corticoesteroides/uso terapéutico , Adulto , Humanos , Inyecciones , Neuroma de Morton/tratamiento farmacológico , Neuroma/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , UltrasonografíaRESUMEN
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.
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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.
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Temperatura Corporal/fisiología , Termometría/métodos , COVID-19/diagnóstico , COVID-19/fisiopatología , Humanos , Guías de Práctica Clínica como Asunto , SARS-CoV-2 , Termómetros/efectos adversos , Termómetros/normas , Termometría/efectos adversos , Termometría/instrumentación , Termometría/normas , IncertidumbreRESUMEN
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.
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Cistatina C , Riñón , Adolescente , Adulto , Estudios de Cohortes , Creatinina , Tasa de Filtración Glomerular , Humanos , Riñón/fisiología , Atención Primaria de SaludRESUMEN
BACKGROUND: Guidelines recommend measuring temperature in children presenting with fever using electronic axillary or tympanic thermometers. Non-contact thermometry offers advantages, yet has not been tested against recommended methods in primary care. AIM: To compare two different non-contact infrared thermometers (NCITs) to axillary and tympanic thermometers in children aged ≤5 years visiting their GP with an acute illness. DESIGN AND SETTING: Method comparison study with nested qualitative component. METHOD: Temperature measurements were taken with electronic axillary (Welch Allyn SureTemp®), electronic tympanic (Braun Thermoscan®), NCIT Thermofocus® 0800, and NCIT Firhealth Forehead. Parents rated acceptability and discomfort. Qualitative interviews explored parents' experiences of the thermometers. RESULTS: In total, 401 children were recruited (median age 1.6 years, 50.62% male). Mean difference between the Thermofocus NCIT and axillary thermometer was -0.14°C (95% confidence interval [CI] = -0.21 to -0.06°C); lower limit of agreement was -1.57°C (95% CI = -1.69 to -1.44°C) and upper limit 1.29°C (95% CI = 1.16 to 1.42°C). A second NCIT (Firhealth) had similar levels of agreement; however, the limits of agreement between tympanic and axillary thermometers were also wide. Parents expressed a preference for the practicality and comfort of NCITs, and were mostly negative about their child's experience of axillary thermometers. But there was willingness to adopt whichever device was medically recommended. CONCLUSION: In a primary care paediatric population, temperature measurements with NCITs varied by >1°C compared with axillary and tympanic approaches. But there was also poor agreement between tympanic and axillary thermometers. Since clinical guidelines often rely on specific fever thresholds, clinicians should interpret peripheral thermometer readings with caution and in the context of a holistic assessment of the child.
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Fiebre/diagnóstico , Atención Primaria de Salud , Termómetros , Axila , Temperatura Corporal , Preescolar , Estudios Transversales , Femenino , Frente , Humanos , Lactante , Rayos Infrarrojos , Masculino , Prioridad del Paciente , Sensibilidad y Especificidad , Membrana TimpánicaRESUMEN
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.
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Registros Electrónicos de Salud , Neoplasias , Electrónica , Inglaterra , Humanos , Neoplasias/diagnóstico , Neoplasias/terapia , Atención Primaria de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Medicina EstatalRESUMEN
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.
General practitioners commonly measure children's temperature using a thermometer placed in the armpit or ear canal. New 'non-contact' thermometers use infrared light to measure temperature without touching the child. They are easy to use and there is no risk of passing on infections. However, we do not know how well they measure temperature compared with thermometers that use the armpit or the ear. This study aimed to compare two non-contact thermometers with current thermometers. We measured children's temperature with all thermometer types, and asked children and their parents about their views. The study was performed in general practices in Oxfordshire with children aged ≤ 5 years who had come to see their general practitioner because they had recently become unwell. Both the cheaper and more expensive non-contact thermometers gave slightly lower temperature readings on average than current thermometers. The vast majority of readings ranged from 1.6 °C lower to 1.3 °C higher than current thermometers. The detection of fever of at least 38 °C was low to moderate for both non-contact thermometers. Most parents did not think that their child was distressed by having their temperature taken using any of the thermometers, but the armpit thermometer was rated as the least comfortable. When interviewed, parents were more negative about the armpit thermometers, although still willing to use them if they were recommended by doctors. Although we found that the readings from the different thermometers did not match, we do not know whether the non-contact or the current thermometers were giving readings that were closer to the real temperature of the child. To understand this, we would need to do a study that included a more invasive procedure for temperature assessment.
Asunto(s)
Temperatura Corporal , Rayos Infrarrojos , Atención Primaria de Salud/métodos , Termómetros/normas , Axila/fisiología , Preescolar , Diseño de Equipo , Femenino , Humanos , Lactante , Entrevistas como Asunto , Masculino , Atención Primaria de Salud/normas , Sensibilidad y Especificidad , Membrana Timpánica/fisiologíaRESUMEN
OBJECTIVE: To assess the feasibility of using a blood pressure (BP) self-measurement kiosk-a solid-cuff sphygmomanometer combined with technology to integrate the BP readings into patient electronic medical records- to improve hypertension detection. DESIGN: A concurrent mixed-methods feasibility study incorporating observational and qualitative interview components. SETTING: Two English general practitioner (GP) surgeries. PARTICIPANTS: Adult patients registered at participating surgeries. Staff working at these sites. INTERVENTIONS: BP self-measurement kiosks were placed in the waiting rooms for a 12-month period between 2015 and 2016 and compared with a 12-month control period prior to installation. OUTCOME MEASURES: (1) The number of patients using the kiosk and agreeing to transfer of their data into their electronic medical records; (2) the cost of using a kiosk compared with GP/practice nurse BP screening; (3) qualitative themes regarding use of the equipment. RESULTS: Out of 15 624 eligible patients, only 186 (1.2%, 95% CI 1.0% to 1.4%) successfully used the kiosk to directly transfer a BP reading into their medical record. For a considerable portion of the intervention period, no readings were transferred, possibly indicating technical problems with the transfer link. A comparison of costs suggests that at least 52.6% of eligible patients would need to self-screen in order to bring costs below that of screening by GPs and practice nurses. Qualitative interviews confirmed that both patients and staff experienced technical difficulties, and used alternative methods to enter BP results into the medical record. CONCLUSIONS: While interviewees were generally positive about checking BP in the waiting room, the electronic transfer system as tested was neither robust, effective nor likely to be a cost-effective approach, thus may not be appropriate for a primary care environment. Since most of the cost of a kiosk system lies in the transfer mechanism, a solid-cuff sphygmomanometer and manual entry of results may be a suitable alternative.
Asunto(s)
Determinación de la Presión Sanguínea/métodos , Presión Sanguínea/fisiología , Hipertensión/diagnóstico , Autocuidado/métodos , Anciano , Determinación de la Presión Sanguínea/economía , Determinación de la Presión Sanguínea/estadística & datos numéricos , Costos y Análisis de Costo , Diagnóstico Precoz , Utilización de Instalaciones y Servicios , Estudios de Factibilidad , Femenino , Medicina General/estadística & datos numéricos , Humanos , Hipertensión/economía , Hipertensión/fisiopatología , Masculino , Persona de Mediana Edad , Aceptación de la Atención de Salud/estadística & datos numéricos , Autocuidado/estadística & datos numéricos , Reino UnidoRESUMEN
OBJECTIVE: To evaluate the effects of drug interventions that may modify the progression of chronic kidney disease (CKD) in adults with CKD stages 3 and 4. DESIGN: Systematic review and meta-analysis. METHODS: Searching MEDLINE, EMBASE, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, International Clinical Trials Registry Platform, Health Technology Assessment, Science Citation Index, Social Sciences Citation Index, Conference Proceedings Citation Index and Clinical Trials Register, from March 1999 to July 2018, we identified randomised controlled trials (RCTs) of drugs for hypertension, lipid modification, glycaemic control and sodium bicarbonate, compared with placebo, no drug or a drug from another class, in ≥40 adults with CKD stages 3 and/or 4, with at least 2 years of follow-up and reporting renal function (primary outcome), proteinuria, adverse events, maintenance dialysis, transplantation, cardiovascular events, cardiovascular mortality or all-cause mortality. Two reviewers independently screened citations and extracted data. For continuous outcomes, we used the ratio of means (ROM) at the end of the trial in random-effects meta-analyses. We assessed methodological quality with the Cochrane Risk of Bias Tool and confidence in the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. RESULTS: We included 35 RCTs and over 51 000 patients. Data were limited, and heterogeneity varied. Final renal function (estimated glomerular filtration rate) was 6% higher in those taking glycaemic control drugs (ROM 1.06, 95% CI 1.02 to 1.10, I2=0%, low GRADE confidence) and 4% higher in those taking lipid-modifying drugs (ROM 1.04, 95% CI 1.00 to 1.08, I2=88%, very low GRADE confidence). For RCTs of antihypertensive drugs, there were no significant differences in renal function. Treatment with lipid-modifying drugs led to a 36% reduction in cardiovascular disease and 26% reduction in all-cause mortality. CONCLUSIONS: Glycaemic control and lipid-modifying drugs may slow the progression of CKD, but we found no pooled evidence of benefit nor harm from antihypertensive drugs. However, given the data limitations, further research is needed to confirm these findings. PROSPERO REGISTRATION NUMBER: CRD42015017501.
Asunto(s)
Antihipertensivos/uso terapéutico , Hipoglucemiantes/uso terapéutico , Hipolipemiantes/uso terapéutico , Insuficiencia Renal Crónica/tratamiento farmacológico , Bicarbonato de Sodio/uso terapéutico , Adulto , Progresión de la Enfermedad , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: Out-of-office blood pressure (BP) measurement is advocated to confirm hypertension diagnosis. However, little is known about how primary care patients view and use such measurement. AIM: To investigate patient experience of out-of-office BP monitoring, particularly home and practice waiting room BP measurement, before, during, and after diagnosis. DESIGN AND SETTING: A cross-sectional, qualitative study with patients from two UK GP surgeries participating in a feasibility study of waiting room BP measurement. METHOD: Interviewees were identified from recent additions to the practice hypertension register. Interviews were recorded, transcribed, and coded thematically. RESULTS: Of 29 interviewees, 9 (31%) and 22 (76%) had used the waiting room monitor and/or monitored at home respectively. Out-of-office monitoring was used by patients as evidence of control or the lack of need for medication, with the printed results slips from the waiting room monitor perceived to improve 'trustworthiness'. The waiting room monitor enabled those experiencing uncertainty about their equipment or technique to double-check readings. Monitoring at home allowed a more intensive and/or flexible schedule to investigate BP fluctuations and the impact of medication and lifestyle changes. A minority used self-monitoring to inform drug holidays. Reduced intensity of monitoring was reported with both modalities following diagnosis as initial anxiety or patient and GP interest decreased. CONCLUSION: Home and practice waiting room measurements have overlapping but differing roles for patients. Waiting room BP monitors may be a useful out-of-office measurement modality for patients unwilling and/or unable to measure and record their BP at home.