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Establishment of a Clinic-based Biorepository

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Published on: May 29, 2017

Limitations of the Hoffmann method for establishing reference intervals using clinical laboratory data.

Ying Zhang¹, Weibo Ma², Guocheng Wang³

¹Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China; Department of Epidemiology and Biostatistics, School of Public Health, Capital Medical University, Beijing 100069, China.

Clinical Biochemistry

|November 12, 2018

Summary

The Hoffmann method

Keywords:

Acceptable deviation Hoffmann method Pregnancy Reference intervals Thyroid hormones

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Area of Science:

Clinical Biochemistry
Laboratory Medicine
Reference Interval Determination

Background:

Establishing accurate reference intervals (RIs) is crucial for interpreting laboratory test results.
The Hoffmann method is commonly used for RI determination, but its sensitivity to 'limits of acceptability' is not fully understood.
Previous studies suggest the default parameters may not always yield optimal results for defining healthy populations.

Purpose of the Study:

To investigate the impact of varying acceptable deviation (α) values on the Hoffmann method for selecting healthy populations.
To evaluate the validity of reference intervals generated with different α values using prospective data.
To determine appropriate acceptable deviation limits for thyroid stimulating hormone (TSH) and free thyroxine (FT4) RIs.

Main Methods:

Thyroid stimulating hormone (TSH) and free thyroxine (FT4) levels were measured in a large cohort (n>10,000).
Reference intervals (RIs) were calculated using the Hoffmann method with diverse acceptable deviation (α) values.
Prospective validation assessed out-of-range (OOR) values, with RIs deemed valid if OOR < 10%.

Main Results:

Increasing the α value resulted in wider reference intervals (RIs).
The default α value of 0.05 produced RIs narrower than expected, with significantly higher OOR rates for TSH and FT4.
OOR rates fell below 10% only when α was adjusted to 0.55 for TSH and 0.80 for FT4, validating the adjusted RIs.

Conclusions:

The selection of acceptable deviation in the Hoffmann method can be subjective.
The default α value (0.05) may not be universally applicable for establishing robust reference intervals.
Determining acceptable deviation requires careful consideration of specific conditions rather than relying solely on default values.