Gillian Lancaster

Infrared ear thermometry compared with rectal thermometry in children: a systematic review

BACKGROUND Infrared ear thermometry is frequently used in children, because this is a quick method of taking temperature and the ear is easily accessible. Our aim was to evaluate agreement between temperature measured at the rectum and ear in children. METHODS We did a systematic review of studies comparing temperature measured at the rectum (the reference site) using mercury, electronic, or indwelling probe thermometers, with temperature measured at the ear (the test site) using infrared ear thermometers. Heterogeneity between studies was investigated by exploring subgroups according to the mode of the infrared ear thermometer. FINDINGS 44 studies containing 58 comparisons (5935 children) were eligible for inclusion in this review. Outcome data were available in reports from 12 comparisons (2312 [39%] children), and data on individual patients were obtained for a further 19 comparisons (2129 [36%] children). 31 comparisons (4441 [75%] children) were therefore included in the meta-analysis. The pooled mean temperature difference (rectal minus ear) was 0.29 degrees C (95% limits of agreement -0.74 to 1.32). We pooled data by ear device mode and the mean temperature differences were rectal mode 0.15 degrees C (-0.95 to 1.25), actual 0.70 degrees C (-0.20 to 1.60), core 0.25 degrees C (-0.78 to 1.27), oral 0.34 degrees C (-0.86 to 1.54), tympanic 0.62 degrees C (-0.40 to 1.64) and mode not stated 0.32 degrees C (-0.57 to 1.21). There was significant residual heterogeneity in both mean differences and sample SDs within the groups of ear device mode. INTERPRETATION Although the mean differences between rectal and ear temperature measurements were small, the wide limits of agreement mean that ear temperature is not a good approximation of rectal temperature, even when the ear thermometer is used in rectal mode. Our finding suggests that infrared ear thermometry does not show sufficient agreement with an established method of temperature measurement to be used in situations where body temperature needs to be measured with precision.

Temperature measured at the axilla compared with rectum in children and young people: systematic review

Abstract Objective: To evaluate the agreement between temperature measured at the axilla and rectum in children and young people Design: A systematic review of studies comparing temperature measured at the axilla (test site) with temperature measured at the rectum (reference site) using the same type of measuring device at both sites in each patient. Devices were mercury or electronic thermometers or indwelling thermocouple probes. Studies reviewed: 40 studies including 5528 children and young people from birth to 18 years. Data extraction: Difference in temperature readings at the axilla and rectum. Results: 20 studies (n=3201 (58%) participants) had sufficient data to be included in a meta-analysis. There was significant residual heterogeneity in both mean differences and sample standard deviations within the groups using different devices and within age groups. The pooled (random effects) mean temperature difference (rectal minus axillary temperature) for mercury thermometers was 0.25°C (95% limits of agreement −0.15°C to 0.65°C) and for electronic thermometers was 0.85°C (−0.19°C to 1.90°C). The pooled (random effects) mean temperature difference (rectal minus axillary temperature) for neonates was 0.17°C (−0.15°C to 0.50°C) and for older children and young people was 0.92°C (−0.15°C to 1.98°C). Conclusions: The difference between temperature readings at the axilla and rectum using either mercury or electronic thermometers showed wide variation across studies. This has implications for clinical situations where temperature needs to be measured with precision.

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.

A population-based investigation of behavioural and emotional problems and maternal mental health: associations with autism spectrum disorder and intellectual disability

BACKGROUND While research indicates elevated behavioural and emotional problems in children with autism spectrum disorders (ASD) and decreased well-being in their parents, studies do not typically separate out the contribution of ASD from that of associated intellectual disabilities (ID). We investigated child behavioural and emotional problems, and maternal mental health, among cases with and without ASD and ID in a large population-representative sample. METHODS Cross-sectional comparison of child behavioural and emotional problems and maternal mental health measures among 18,415 children (5 to 16 years old), of whom 47 had an ASD, 51 combined ASD with ID, 590 had only ID, and the remainder were the comparison group with no ASD or ID. RESULTS The prevalence of likely clinical levels of behavioural and emotional problems was highest among children with ASD (with and without ID). After controlling for age, gender, adversity, and maternal mental health, the presence of ASD and ID significantly and independently increased the odds for hyperactivity symptoms, conduct, and emotional problems. Emotional disorder was more prevalent in mothers of children with ASD (with or without ID). The presence of ASD, but not ID, significantly increased the odds for maternal emotional disorder. As has been found in previous research, positive maternal mental health was not affected by the presence of ASD or ID. CONCLUSIONS ASD and ID are independent risk factors for behavioural and emotional problems. ASD (but not ID) is positively associated with maternal emotional disorder. Approaches to diagnosing hyperactivity and conduct problems in children with ASD may need to be reconsidered.

Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms ‘pilot’ and ‘feasibility’ in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms ‘feasibility’ or ‘pilot’ as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term ‘feasibility’ in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

Pilot and feasibility studies come of age

This editorial introduces the new, online, open-access journal Pilot and Feasibility Studies. The journal considers manuscripts on any aspect of the design and analysis of pilot and feasibility studies, as well as protocols for pilot and feasibility studies, and discussions and reviews of methodological issues around the planning and reporting of such studies. These studies are generally carried out in preparation for future large-scale definitive randomised controlled trials or observational studies and address key issues of uncertainty. Objectives for conducting pilot and feasibility studies therefore differ from those of the future large-scale study and should be clearly expressed. The journal provides a dedicated place for publication of this important work as well as a forum for discussion of methodological issues that will lead to increased scientific rigour in this area.

The Malawi Developmental Assessment Tool (MDAT): The Creation, Validation, and Reliability of a Tool to Assess Child Development in Rural African Settings

Melissa Gladstone and colleagues evaluate the reliability and validity of an assessment tool for evaluating child development in rural African settings.

Breast asymmetry and predisposition to breast cancer

IntroductionIt has been shown in our previous work that breast asymmetry is related to several of the known risk factors for breast cancer, and that patients with diagnosed breast cancer have more breast volume asymmetry, as measured from mammograms, than age-matched healthy women.MethodsIn the present study, we compared the breast asymmetry of women who were free of breast disease at time of mammography, but who had subsequently developed breast cancer, with that of age-matched healthy controls who had remained disease-free to time of the present study. The study group consisted of 252 asymptomatic women who had normal mammography, but went on to develop breast cancer. The control group were 252 age-matched healthy controls whose mammograms were also normal and who remained free of cancer during the study period. Breast volume was calculated from the cranio-caudal mammograms for each group, and the relationships between asymmetry, established risk factors and the presence or absence of breast cancer were explored.ResultsThe group who went on to develop breast cancer had higher breast asymmetry than controls (absolute asymmetry odds ratio 1.50 per 100 ml, confidence interval (CI) 1.10, 2.04; relative asymmetry 1.09, CI 1.01, 1.18), increased incidence of family history of breast cancer, lower age at menarche, later menopause, later first pregnancies and a higher frequency of high risk breast parenchyma types. Conditional logistic regression analysis showed that breast asymmetry, height, family history of breast cancer, age at menarche, parenchyma type and menopausal status were significant independent predictors of breast cancer. When age at menopause was included in the model for the subgroup of post-menopausal women, absolute breast fluctuating asymmetry (FA) and relative breast FA remained significant effects.ConclusionBreast asymmetry was greater in healthy women who later developed breast cancer than in women who did not.

Psychological processes in bipolar affective disorder: negative cognitive style and reward processing

BACKGROUND Psychological processes in bipolar disorder are of both clinical and theoretical importance. AIMS To examine depressogenic psychological processes and reward responsivity in relation to different mood episodes (mania, depression, remission) and bipolar symptomatology. METHOD One hundred and seven individuals with bipolar disorder (34 in a manic/hypomanic or mixed affective state; 30 in a depressed state and 43 who were euthymic) and 41 healthy controls were interviewed with Structured Clinical Interview for DSM-IV and completed a battery of self-rated and experimental measures assessing negative cognitive styles, coping response to negative affect, self-esteem stability and reward responsiveness. RESULTS Individuals in all episodes differed from controls on most depression-related and reward responsivity measures. However, correlational analyses revealed clear relationships between negative cognitive styles and depressive symptoms, and reward responsivity and manic symptoms. CONCLUSIONS Separate psychological processes are implicated in depression and mania, but cognitive vulnerability to depression is evident even in patients who are euthymic.

Validity and reliability of acoustic analysis of respiratory sounds in infants

Objective: To investigate the validity and reliability of computerised acoustic analysis in the detection of abnormal respiratory noises in infants. Methods: Blinded, prospective comparison of acoustic analysis with stethoscope examination. Validity and reliability of acoustic analysis were assessed by calculating the degree of observer agreement using the κ statistic with 95% confidence intervals (CI). Results: 102 infants under 18 months were recruited. Convergent validity for agreement between stethoscope examination and acoustic analysis was poor for wheeze (κ = 0.07 (95% CI, −0.13 to 0.26)) and rattles (κ = 0.11 (−0.05 to 0.27)) and fair for crackles (κ = 0.36 (0.18 to 0.54)). Both the stethoscope and acoustic analysis distinguished well between sounds (discriminant validity). Agreement between observers for the presence of wheeze was poor for both stethoscope examination and acoustic analysis. Agreement for rattles was moderate for the stethoscope but poor for acoustic analysis. Agreement for crackles was moderate using both techniques. Within-observer reliability for all sounds using acoustic analysis was moderate to good. Conclusions: The stethoscope is unreliable for assessing respiratory sounds in infants. This has important implications for its use as a diagnostic tool for lung disorders in infants, and confirms that it cannot be used as a gold standard. Because of the unreliability of the stethoscope, the validity of acoustic analysis could not be demonstrated, although it could discriminate between sounds well and showed good within-observer reliability. For acoustic analysis, targeted training and the development of computerised pattern recognition systems may improve reliability so that it can be used in clinical practice.