Abstract
Aims
There is still debate as to whether the addition of interpretative comments to laboratory reports can influence the management of patients. Little is known about the extent of this activity in individual laboratories throughout the UK and so this national survey aimed to establish the prevalence.
Methods
An electronic questionnaire was sent to 196 NHS laboratories in the UK asking whether 17 commonly requested groups of tests were reported with interpretative comments and, if so, how laboratory computers and/or humans were involved in the process. Enquiries were also made of the grades of staff performing the process and of any ‘vignette’ examples where interpretative reporting had improved the clinical outcome for the patient.
Results
A total of 138 of the 196 laboratories (70%) responded. Only two laboratories did not have staff adding interpretative comments to any of the 17 tests. Consultant laboratory staff reporting predominated in all tests with a significant minority also being added by biomedical scientists. High-volume requests usually had staff adding comments to results selected by computer rules whereas more of the specialist endocrine tests tended to be considered for comment. Only six of 71 vignettes referred specifically to ‘routine’ biochemistry.
Conclusions
The addition of interpretative comments onto clinical biochemistry reports is widespread throughout the UK. This service is largely consultant led. There is anecdotal evidence that the process can influence the clinical management of patients.
Introduction
Clinical validation is the post-analytical addition of written remarks onto a laboratory report aimed at helping the requesting clinician fully interpret the findings of a test. 1 The inclusion of these interpretative comments is thought to be widely practised in the UK, but there continues to be debate about the benefits, or otherwise, of their inclusion. 2,3
Irrespective of any influence on patient care, it is not known as to how individual clinical biochemistry laboratories currently implement clinical validation as part of the service they provide to requesters. For example, it is not known if the breadth of tests that have interpretative comments added varies from laboratory to laboratory. Likewise, it is not known which grades of staff participate in this role. This survey therefore sought to establish the scope of interpretative reporting within the UK and also asked laboratories for examples where, in their experience, this has made a difference to the clinical management of the patient.
Methods
A questionnaire was devised by authors DBF, ESK and the National Clinical Biochemistry Audit Group for distribution to all known NHS laboratories within the UK in 2009. Information on the reporting of 17 commonly requested sets of biochemistry tests was sought, including the use of computers and humans in adding interpretative comments and the grades of staff participating. Recipients were also asked to include ‘vignette’ examples where they felt interpretative reporting had made an unequivocal contribution (beneficial or otherwise) to a patient.
The questionnaire was then distributed electronically using SurveyMonkey (
Results
One hundred and ninety-six questionnaires were sent and 138 returned, giving a response rate of 70%. One laboratory which dealt mainly with immunology requests did not analyse any of the tests in the questionnaire and so was excluded from further analysis. Table 1 shows the number of these laboratories who added interpretative comments of any type to the report for the tests indicated.
Responses to ‘Which of the following tests are carried out in your laboratory?’
U&E, urea and electrolytes; LFT, liver function test; TFT, thyroid function test; PTH, parathyroid hormone
Table 2 gives a breakdown of how interpretative comments were added. Most were self-explanatory. Addition of ‘set’ or ‘coded’ comments referred to a human adding predefined phrases to the report; adding comments ‘realtime’ meant before the report was released; while adding comments ‘reflectively’ was defined here as reviewing after the report had been released. Individual laboratories could be reporting comments in several different ways at the same time. Thus, a single report could, for example, contain test comments generated by a computer, have another included by a human as a set comment and also have additional free text.
Responses to ‘Are the comments generated by computer or human? Please tick all that apply’
U&E, urea and electrolytes; LFT, liver function test; TFT, thyroid function test; PTH, parathyroid hormone; SST, short synacthen test
Nonetheless, there were some discrepancies between the responses of Table 1 and that of Table 2, either because of simple mistakes in completing the questionnaire or ambiguities in the questions being asked. For example, one of the 95 laboratories who included comments with tumour marker results did not respond to how the computer and/or the human added them. Most discrepant was the case where three of the six laboratories that did not add interpretation to catecholamine reports in Table 1 did so in Table 2.
Table 3 shows the grades of staff who participated in interpretative reporting.
Responses to ‘Which grade(s) of staff provide the comments? Please tick all that apply.’
U&E, urea and electrolytes; LFT, liver function test; TFT, thyroid function test; PTH, parathyroid hormone; SST, short synacthen test
Discussion
This national survey has shown that the addition of interpretative comments onto Clinical Biochemistry reports is widespread throughout the UK. Only two laboratories out of the 137 who responded described no form of human input in placing textual interpretative comments on the reports of any of these commonly requested tests. One is a paediatric service that discusses all unusual results with the appropriate clinician and the other was a district general hospital where the philosophy is to encourage users of the service to contact the laboratory for verbal advice rather than placing interpretative text on the report.
Between laboratories there is a consistency in the way in which these comments are added. For example, Table 2 shows that high-volume tests such as urea and electrolyte and thyroid function test comments are mainly added by humans to test results that have already been filtered by the laboratory computer, whereas with other endocrine tests all reports tend to be considered for commenting. The laboratory computer is also used to support rather than replace human reporting by adding comments automatically according to rules and being a store for set or coded comments. The 24-h service provided by most laboratories probably necessitates the third of laboratories reviewing ‘routine’ biochemistry results after the result has already left the laboratory, but the same is also true for around one-fifth of laboratories reporting thyroid tests.
Table 3 shows that interpretative reporting is predominantly consultant led. An oversight of the questionnaire was in not asking if a grade of staff actually existed in a particular laboratory, and so it is not known if the proportion of consultants reporting is any different from that of other clinical scientists or medics. A significant minority of laboratories also have biomedical scientists adding comments, especially with routine biochemistry and thyroid function tests, and in all of these instances a senior medic or clinical scientist also participates.
There is ongoing discussion within the profession around the benefits, or not, of including interpretative comments on reports. Opinions vary from recommending them to be an integral part of the laboratory service 2 to opposing their use, at least until evidence of benefit is established. 3 There is certainly evidence that service users favour the provision of interpretative comments as well as appreciating additional testing, where appropriate. 4,5 It has also been established in a UK service that over 75% of the recipients of report comments feel they influence patient management, for some tests at least. 6 In a separate study, a temporal relationship between the introduction of thyroid comments and a subsequent reduction in the proportion of patients inadequately replaced with levothyroxine has been found. 7 In contrast, an Australasian study found a worryingly large proportion of comments could be inappropriate or, in some cases, potentially dangerous. 8 The authors recommended that interpretation should be limited to individuals who demonstrate clear expertise in their area of interpretative reporting.
There would be little need for the comments at all if a similar expertise among test requesters could always be guaranteed. However, changes to undergraduate and junior doctor teaching in the UK have generally led to a reduction in the exposure of students to the pathology disciplines. This has resulted in doctors themselves identifying a training need in clinical biochemistry interpretation 9 which, in turn, has led to calls for this national teaching issue to be addressed. 10,11 Medics aside, there is also an increasing reliance on other health-care staff to help in the management of patients, especially those with chronic illnesses. This combination of medical staff lacking confidence and of other staff with little or no formal training in data interpretation means that clinical advice and interpretative comments from the laboratory are likely to become more necessary in the future.
In the questionnaire, examples were given where the laboratory intervened and led to the avoidance of an acute admission or outpatient appointment. Many respondents made specific comments stating that GPs wanted more interpretative comments and found this an invaluable part of the ‘laboratory service’. Common themes in the responses included raised serum potassium concentrations in GP samples due to pseudohyperkalaemia as a result of high platelet or white cell count. There were numerous examples of hypomagnesaemia as a cause of both hypocalcaemia and hypokalaemia that would have otherwise been missed. In addition, there were several cases of secondary hypercholesterolaemia due to hypothyroidism, nephrotic syndrome or primary biliary cirrhosis. Adding cortisol requests to patients with normal thyroid stimulating hormone (TSH) and low free thyroxine concentrations with the subsequent discovery of potential hypopituitarism was a frequent occurrence. In fact, one response stated ‘added cortisol in patient with normal TSH and low FT4 in patient with persistent headache. Cortisol level less than 50 nmol/L. Commented and telephoned to GP. Evidently MRI scan missed pituitary problem and the clinician said the interpretative comments “saved the patient's life!”’ In another similar example, the Duty Biochemist actually received a personal letter of thanks from the patient stating they had made a major contribution to the patient's diagnosis. One observation of note is that despite over 70% of respondents adding comments to ‘routine’ biochemistry results (urea and electrolytes, liver function tests, bone biochemistry), only six of the 71 vignettes related to these tests.
For a full list of interpretative comments that made an unequivocal contribution to a patient or patients, please see the online appendix at
In summary, this survey has shown that despite the often polarized debate surrounding the inclusion of interpretative comments, the practice is very prevalent within the UK and is provided mainly by senior laboratory staff. Although much time and effort seems to be expended on adding comments to routine biochemistry, surprisingly few vignettes highlighted the benefit of including them in this test group. Together, these data could form the basis for ‘best practice’ guidance in this area of laboratory practice.
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