Progress in laboratory testing of thyroid disease

Notes and comments from individual physicians and members of patient groups

Committee members reached out to endocrinologists, clinicians and patient organizations, seeking their views about benefits of having harmonized measurements, risks associated with changes in RIs, and roles of stakeholders in the implementation of standardization.

One means of outreach was conducted in the form of letters to the editors that were published in relevant scientific journals, newsletters from patient organizations, and by contacting representatives from individual organizations. References of outreach letters published in journals and newsletters:

Reponses were received from individual physicians and representatives from clinical and patient organizations. In general, method standardization was perceived as very important and beneficial to patients long-term. While no significant problems are anticipated for implementing TSH harmonization, changes related to fT4 standardization would require appropriate education of all stakeholders including primary care physicians. Some individuals pointed out that a high variability among results generated by different laboratories exist, which creates some level of confusion among health care providers. Comments and notes from individuals are summarized below. Comments are anonymized to ensure the privacy of the respondents:

“…Standardization of TSH measurement across labs is the only way to insure consistent levothyroxine dosing…”

… My question is, why are there different reference ranges, and wouldn't it make more sense for a standard reference range to be available for everyone?...”

“…I foresee no problem with the Reference interval change at the lower level if the assays are standardized.  It is above the reference range that will cause the most grief to the endocrinologists…”

“…I suspect that they [physicians] will accept TSH harmonization because they won't have to do anything other than note minor 'tweaks' to the TSH reference interval when advised by their lab…”

“…Successful implementation of TSH harmonization will win 'hearts and minds' in a non-threatening way. This should help to gain support for FT4 standardization at a later date…”

“…: time is ripe to push harmonization of TSH given this dependence on specific cut-offs (…) and we probably need to pursue some studies using pregnancy samples…”

“…Implementation: I think it will be easy to implement. One of my referring labs has changed 3 times during the last 4 years without any problem…”

“…Standardization and harmonization programs are highly appreciated…”

“…Great benefit if all patients’ results are comparable independent of the platform they are measured at. We often see that different reference intervals are used by laboratories while obtained by the same supplier. Patients often do not understand that values are laboratory dependent so it will be a step forward. It will result in a reduction in laboratory testing since results will be comparable between physician and hospital….”

“…In the beginning the old and new values should be reported simultaneously to make sure that patients and doctors familiarize with the new levels. Communication is essential as patients often cling to their results…. It will take a while before patient and doctors are used to the new values. Big changes in values often help... The only problem is that all laboratories should adopt this harmonization to make it into a success… One way to achieve this is to perform an extensive reference interval study including the neonatal period…”

“…I can see no foreseeable risks for either physicians or patients...”