Determining the validity of hospital laboratory reference intervals for healthy young adults participating in early clinical trials of candidate vaccines.
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ABSTRACT:
SUBMITTER: Rowland R
PROVIDER: S-EPMC3906276 | biostudies-literature | 2013 Aug
REPOSITORIES: biostudies-literature
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Determining the validity of hospital laboratory reference intervals for healthy young adults participating in early clinical trials of candidate vaccines.
Rowland Rosalind R O'Hara Geraldine A GA Hamill Matthew M Poulton Ian D ID Donaldson Hannah H Dinsmore Laura L James Timothy T Barnes Eleanor E Klenerman Paul P Gilbert Sarah C SC Hill Adrian V S AV Shine Brian B McShane Helen H
Human vaccines & immunotherapeutics 20130603 8
This was a retrospective study to determine the validity of institutional reference intervals for interpreting biochemistry and hematology results in healthy adults in the context of clinical trials of preventive vaccines. An example population of 974 healthy adults participating in clinical trials at the Jenner Institute, Oxford, UK, between 1999 and 2009 was studied. Methods for calculating the central 95% ranges and determining the coefficients of within person variation were demonstrated. Re ...[more]
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Project description:BackgroundThe results of clinical laboratory tests are an essential component of medical decision-making. To guide interpretation, test results are returned with reference intervals defined by the range in which the central 95% of values occur in healthy individuals. Clinical laboratories often set their own reference intervals to accommodate variation in local population and instrumentation. For some tests, reference intervals change as a function of sex, age, and self-identified race and ethnicity.MethodsIn this work, we develop a novel approach, which leverages electronic health record data, to identify healthy individuals and tests for differences in laboratory test values between populations.ResultsWe found that the distributions of >50% of laboratory tests with currently fixed reference intervals differ among self-identified racial and ethnic groups (SIREs) in healthy individuals.ConclusionsOur results confirm the known SIRE-specific differences in creatinine and suggest that more research needs to be done to determine the clinical implications of using one-size-fits-all reference intervals for other tests with SIRE-specific distributions.
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Project description:BackgroundReference intervals are assessment tools for interpretation of clinical test results. These intervals describe the dispersion of test parameter values of apparently healthy persons in defined populations as health status indicators. Using reference intervals obtained and validated in populations outside the geographical region of derivation for medical decision-making may impact negatively on clinical interpretation and patient management. Many countries have established their reference values, current studies on these data for Nigeria are however scarce. Determination of clinical biochemistry reference intervals for young Nigerian adults which is of particular importance in routine clinical management and conduct of clinical trials in response to existing and emerging diseases will add significantly to the existing body of knowledge.ObjectiveThe objective was to establish reference intervals for 24biochemistry analytes among Nigerians aged 18 to 26 years.MethodsThis was a cross-sectional study among 7,797 consenting male and female military applicants aged 18 to 26 years from 37 States of Nigeria. It was a total study among volunteers for military service. Blood samples were collected and subjected to serological testing for HIV-1 and 2, hepatitis-B, malaria, pregnancy and haematuria to restrict our study population to apparently healthy participants. Biochemical assays were performed on 6,169 participant samples that met the inclusion criteria. Generated data was entered into MS Excel® and exported into SPSS® software version 16 for analysis. Statistical tools used were frequencies, median, mid 95th percentile range with 2.5th and 97.5th percentiles as limits. Reference intervals were estimated using nonparametric methods. No intergender statistical comparison was made.ResultsComplete records were obtained for 6,169 eligible participants. Median values and associated reference intervals were similar in both genders.ConclusionThe findings from this study will help in clinical decision-making and play a significant role in supporting the current global rapid expansion of clinical trials in response to the urgent need for preventive and therapeutic solutions to existing and emerging diseases.
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Project description:BackgroundPopulation based reference intervals are fundamental for interpreting results for quantitative laboratory tests. In patients with a specific chronic disorder, however, results of various tests may regularly be different than in healthy individuals. Health-associated reference intervals may therefore have limited value in such patients. Instead, disease-associated reference intervals may be useful, as they describe the results distribution in populations resembling the specific patients. Few disease-associated reference intervals are available in the literature. The aim of this study was to estimate reference intervals for common laboratory tests for patient populations with rheumatoid arthritis, Crohn's disease or ulcerative colitis without significant comorbidity, using a novel algorithm.Material and methodsLaboratory test results and hospital discharge diagnoses were collected for relevant patients. An algorithm was developed to identify discharge diagnoses significantly associated with high or low results for specific tests. After excluding patients with such diagnoses, reference intervals were estimated, representing results distributions in patients with each of the specific chronic disorders, but without significant comorbidity.ResultsDisease-associated reference intervals were estimated for 20 common laboratory tests. Most of the estimated reference limits were significantly different from corresponding health-associated reference limits. Thirty percent of the estimated reference intervals were different from estimates based on crude patient populations, indicating that the algorithm applied managed to exclude patients with relevant comorbidity.ConclusionDisease-associated reference intervals could be estimated for a number of tests in patients with rheumatoid arthritis, ulcerative colitis or Crohn's disease using a highly automated algorithm based on routinely recorded patient data.
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