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Bedside breath tests in children with abdominal pain: a prospective pilot feasibility study.

ABSTRACT: Background:There is no definitive method of accurately diagnosing appendicitis before surgery. We evaluated the feasibility of collecting breath samples in children with abdominal pain and gathered preliminary data on the accuracy of breath tests. Methods:We conducted a prospective pilot study at a large tertiary referral paediatric hospital in the UK. We recruited 50 participants with suspected appendicitis, aged between 5 and 15?years. Five had primary diagnosis of appendicitis. The primary outcome was the number of breath samples collected. We also measured the number of samples processed within 2?h and had CO2 ? 3.5%. Usability was assessed by patient-reported pain pre- and post-sampling and user-reported sampling difficulty. Logistic regression analysis was used to predict appendicitis and evaluated using the area under the receiver operator characteristic curve (AUROC). Results:Samples were collected from all participants. Of the 45 samples, 36 were processed within 2?h. Of the 49 samples, 19 had %CO2 ? 3.5%. No difference in patient-reported pain was observed (p?=?0.24). Sampling difficulty was associated with patient age (p?=?0.004). The logistic regression model had AUROC?=?0.86. Conclusions:Breath tests are feasible and acceptable to patients presenting with abdominal pain in clinical settings. We demonstrated adequate data collection with no evidence of harm to patients. The AUROC was better than a random classifier; more specific sensors are likely to improve diagnostic performance. Trial registration:ClinicalTrials.gov, NCT03248102. Registered 14 Aug 2017.

SUBMITTER: Wong DC

PROVIDER: S-EPMC6833160 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Bedside breath tests in children with abdominal pain: a prospective pilot feasibility study.

Wong David C DC Relton Samuel D SD Lane Victoria V Ismail Mohamed M Goss Victoria V Bytheway Jane J West Robert M RM Deuchars Jim J Sutcliffe Jonathan J

Pilot and feasibility studies 20191105

<h4>Background</h4>There is no definitive method of accurately diagnosing appendicitis before surgery. We evaluated the feasibility of collecting breath samples in children with abdominal pain and gathered preliminary data on the accuracy of breath tests.<h4>Methods</h4>We conducted a prospective pilot study at a large tertiary referral paediatric hospital in the UK. We recruited 50 participants with suspected appendicitis, aged between 5 and 15 years. Five had primary diagnosis of appendicitis. ...[more]

PMID: 31720000

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Project description:ObjectivesTo examine the feasibility and acceptability of breath research in primary care.DesignNon-randomised, prospective, mixed-methods cross-sectional observational study.SettingTwenty-six urban primary care practices.Participants1002 patients aged 18-90 years with gastrointestinal symptoms.Main outcome measuresDuring the first 6 months of the study (phase 1), feasibility of patient enrolment using face-to-face, telephone or SMS-messaging (Short Message Service) enrolment strategies, as well as processes for breath testing at local primary care practices, were evaluated. A mixed-method iterative study design was adopted and outcomes evaluated using weekly Plan-Do-Study-Act cycles, focus groups and general practitioner (GP) questionnaires.During the second 6 months of the study (phase 2), patient and GP acceptability of the breath test and testing process was assessed using questionnaires. In addition a 'single practice' recruitment model was compared with a 'hub and spoke' centralised recruitment model with regards to enrolment ability and patient acceptability.Throughout the study feasibility of the collection of a large number of breath samples by clinical staff over multiple study sites was evaluated and quantified by the analysis of these samples using mass spectrometry.Results1002 patients were recruited within 192 sampling days. Both 'single practice' and 'hub and spoke' recruitment models were effective with an average of 5.3 and 4.3 patients accrued per day, respectively. The 'hub and spoke' model with SMS messaging was the most efficient combined method of patient accrual. Acceptability of the test was high among both patients and GPs. The methodology for collection, handling and analysis of breath samples was effective, with 95% of samples meeting quality criteria.ConclusionsLarge-scale breath testing in primary care was feasible and acceptable. This study provides a practical framework to guide the design of Phase III trials examining the performance of breath testing in primary care.

Project description:BackgroundCryptosporidiosis is a common cause of diarrhoea in young children (aged younger than 24 months) in low-resource settings but is currently challenging to diagnose. Light-emitting diode fluorescence microscopy with auramine-phenol staining (LED-AP), recommended for tuberculosis testing, can also detect Cryptosporidium species. A lateral-flow test not requiring refrigerator storage (by contrast with most immunochromatographic lateral-flow assays) has also recently been developed for Cryptosporidium spp detection. We aimed to evaluate the diagnostic accuracy and operational feasibility of LED-AP and the lateral-flow test strip for cryptosporidiosis in children.MethodsWe did a prospective diagnostic accuracy study in two health-care facilities in Ethiopia, in a consecutive series of children younger than 5 years of age with diarrhoea (three or more loose stools within the previous 24 h) or dysentery (at least one loose stool with stains of blood within the previous 24 h). Stool samples were tested for Cryptosporidium spp by LED-AP and the lateral-flow test strip; accuracy of each test was estimated by independent and blind comparison with a composite reference standard comprising quantitative immunofluorescent antibody test (qIFAT), ELISA, and quantitative PCR (qPCR). Quantitative cutoff values for diarrhoea-associated infection were established in an embedded case-control substudy, with cases of cryptosporidiosis coming from the 15 districts in and around Jimma and the eight districts surrounding Serbo, and community controls without diarrhoea in the previous 48 h recruited by weekly frequency matching by geographical district of the household, age group, and enrolment week.FindingsStool samples from 912 children with diarrhoea or dysentery and 706 controls from the case-control substudy were tested between Dec 22, 2016, and July 6, 2018. Estimated reference-standard cutoff values for cryptosporidiosis positivity were 2·3 × 105 DNA copies per g of wet stool for qPCR, and 725 oocysts per g for qIFAT. LED-AP had a sensitivity for cryptosporidiosis of 88% (95% CI 79-94; 66 of 75 samples) and a specificity of 99% (98-99; 717 of 726 samples); the lateral-flow test strip had a sensitivity of 89% (79-94; 63 of 71 samples) and a specificity of 99% (97-99; 626 of 635 samples).InterpretationLED-AP has high sensitivity and specificity for cryptosporidiosis and should be considered as a dual-use technology that can be easily integrated with existing laboratory infrastructures in low-resource settings. The lateral-flow test strip has similar sensitivity and specificity and provides an alternative that does not require microscopy, although purchase cost of the test strip is unknown as it is not yet available on the market.FundingNorwegian Research Council GLOBVAC fund, The Bill & Melinda Gates Foundation, Norwegian Society for Medical Microbiology, University of Bergen, and Vestfold Hospital Trust.

Project description:BACKGROUND:Pneumoperitoneum is a rare cause of abdominal pain characterized by a high mortality. Ultrasonography (US) can detect free intraperitoneal air; however, its accuracy remains unclear. The aims of this pilot study were to define the diagnostic performance and the reliability of abdominal US for the diagnosis of pneumoperitoneum. METHODS:This was a prospective observational study. Four senior and two junior physicians were shown, in an unpaired randomized order, abdominal US videos from 11 patients with and 11 patients without pneumoperitoneum. Abdominal US videos were obtained from consecutive patients presenting to ED complaining abdominal pain with the diagnosis of pneumoperitoneum established by CT. Abdominal US was performed according to a standardized protocol that included the following scans: epigastrium, right and left hypochondrium, umbilical area and right hypochondrium with the patient lying on the left flank. We evaluated accuracy, intra- and inter-observer agreement of abdominal US when reviewed by senior physicians. Furthermore, we compared the accuracy of a "2 scan-fast exam" (epigastrium and right hypochondrium) vs the full US examination and the accuracy of physicians expert in US vs nonexpert ones. Finally, accuracy of US was compared with abdominal radiography in patients with available images. RESULTS:Considering senior revision, accuracy of abdominal US was 88.6 % (95 % CI 79.4-92.4 %) with a sensitivity of 95.5 % (95 % CI 86.3-99.2 %) and a specificity of 81.8 % (95 % CI 72.6-85.5 %). Inter- and intra-observer agreement (k) were 0.64 and 0.95, respectively. Accuracy of a "2 scan-fast exam" (87.5 %, 95 % CI 77.9-92.4 %) was similar to global exam. Sensitivity of abdominal radiography (72.2 %, 95 % CI 54.8-85.7 %) was lower than that of abdominal US, while specificity (92.5 %, 95 % CI 79.5-98.3 %) was higher. Accuracy (68.2 %, 95 % CI 51.4-80.9 %) of junior reviewers evaluating US was lower than senior reviewers. CONCLUSIONS:Senior physicians can recognize US signs of pneumoperitoneum with a good accuracy and reliability; sensitivity of US could be superior to abdominal radiography and a 2 fast-scan exam seems as accurate as full abdominal examination. US could be a useful bedside screening test for pneumoperitoneum. Trial registry ClinicalTrials.gov; No.: NCT02004925; URL: http://www.clinicaltrials.gov.

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Bedside breath tests in children with abdominal pain: a prospective pilot feasibility study.

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Bedside breath tests in children with abdominal pain: a prospective pilot feasibility study.

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