Direct patient access to test results: implications for the laboratory

Over the past 30 years, healthcare delivery has evolved from a culture of ‘doctor-knows-best’ paternalism to one in which in which we aspire to place patients at the centre of all decision making. A consequence of this culture change has been greater transparency, better informed patients, increased engagement and greater satisfaction with care. An important element in this has been the sharing of medical records (including test results) with patients.^1,2

Access to medical records has been enshrined in law both in the UK and in the United States (US). Since 1998, patients in the UK have had a legal right to see their medical records; by 2014, one-fifth of patients in England were able to access general practitioner (GP) records online. Since April 2015, GPs in England have been required to offer patients online access to summary record information, although individual practices may decide how much additional information (such as laboratory test results) will be disclosed over and above the summary record. In 2014, the US Department of Health and Human Services mandated that all laboratories must make test results available directly to patients within 30 days of receipt of a request. The latter legislation was prompted in part by high-profile cases in which laboratory reports indicating cancer diagnoses were overlooked by the clinician and not acted upon.

Direct access by patients to test results will have significant implications for both clinical and laboratory practice. Traditionally, patients have accessed test results through the responsible clinician, who places the results in the context of other clinical or diagnostic information and explains what they mean in terms of treatment decisions. However, in practice this model often has worked poorly and to the detriment of patients. ³ Failure to act on critical results has been a particular concern, with evidence that between 6.8% and 62% of abnormal laboratory results in a community or outpatient care setting are never followed up. ⁴ The clinical impact of this has included missed cancer diagnoses, avoidable hospitalization and avoidable adverse drug reactions. Furthermore, the process may be slow, with patients commonly not receiving test results until the next scheduled clinic appointment.^3,4 Such delays may cause anxiety for patients and compromise effective patient–clinician engagement.

Many patients in the UK already view laboratory results directly through online portals such as Renal Patient View. ⁵ This NHS portal allows patients with chronic kidney conditions to access their latest laboratory results, along with other clinical information on diagnosis and treatment. With 17,000 patients registered and 1000 access episodes per week, it is clear that this is a popular resource. Other evidence confirms that patients welcome direct access and that it facilitates greater engagement with treatment and better preparation for clinic visits.^6,7 Concerns have been expressed that patients might not understand the test results, that abnormal test results might cause anxiety and that it might increase workload of clinical staff. There is only limited evidence to support these fears. In a US survey of Kaiser Permanente health insurance scheme patients, the emotional impact of viewing test results online was strongly positive with only a small proportion of patients reporting negative feelings. ⁷ The most common action taken after viewing results was to discuss with family and friends; only 5% of respondents felt the need to make an additional appointment to see the doctor or nurse. ⁷

The primary responsibility for acting on and communicating laboratory test results will always rest with the requesting clinician. There is evidence that the mere fact that patients can access test results independently of clinical staff alters clinician behaviour, by encouraging a more detailed discussion in advance on why particular tests are being performed and what the results might mean. ⁷ This in turn is associated with greater patient satisfaction with care.^2,7 The responsible clinician will need to make available communication channels so that patients can discuss in a timely manner results about which they have concerns.

What are the implications for the laboratory? There will certainly be a need to develop alternative ways of presenting data. The conventional method of reporting a numerical result with a reference interval may not be universally understood by patients. A recent study found that only half of lay subjects presented with a result and reference interval were able correctly to identify that a result was outside range. ⁸ The ability to do so varied with numeracy and literacy levels. Laboratories will need to consider alternative non-numerical report formats such as the incorporation of coloured graphs and charts, perhaps annotated with additional information on questions that patients might pose or links to other websites such as LabTestsOnlineUK (LTO) ⁹ where such information can be accessed. LTO is a non-commercial site directed at patients, designed and maintained by laboratory clinicians and scientists, which provides information on a comprehensive range of tests grouped by both test and disease. There will be a need to review how interpretive comments on the report can be presented in a way that will be most informative to patients. Direct patient access to tests results also provides further impetus (if any were needed) for the need to harmonize, wherever possible, reference ranges and reporting units between laboratories.

Finally, might the laboratory provide a service directly to patients whereby laboratory clinicians and scientists are available by telephone or email to discuss test results? Research will be required as to whether such an approach can contribute positively to the patient experience and in particular whether it can be delivered in a way that does not compromise patient safety and complements rather than conflicts with the actions of the responsible clinician.

The era of direct patient access to test results has arrived. This will have a major impact on laboratory practice and there is a need for research on how laboratories can present results and engage directly with patients in a way that will contribute maximally to safe and effective care.