Category: Clinical

Month: 17 Dec 2015

Issue: not yet available

Systematic research shows insufficient use of patient reported outcomes in AMD clinical trials.

Systematic research into the use of patient reported outcomes in clinical trials for AMD has concluded that adoption of an agreed standard tool would improve the value of randomised controlled trials (RCTs). The study, conducted by a Northern Irish research team based in Belfast’s Royal Victoria Hospital, showed that as little as 14.1% of RCTs used patient reported outcomes as part of their clinical trial endpoints. While many commentators have highlighted the importance of patient reported outcomes in assessing AMD interventions, increased efforts to promote such tools will be required before their use in clinical trials becomes common place.

 

Patient reported outcomes are generally captured through the use of quality-of-life questionnaires, such as the NEI-VFQ-25 (the National Eye Institute Visual Functioning Questionnaire-25) or the EQ-5D (European Quality of Life-5 Dimension). Such questionnaires are normally based on physical, social and psychological aspects of recovery and aim to reflect the more subjective patient responses to particular treatments. Of the 177 RCTs examined in the current study, patient reported outcomes were used in 25 trials (14.1%), with the NEI-VFQ-25 being used most frequently (64% of RCTs). In all, a total of 858 clinical, patient reported and adverse outcomes were identified among the 177 trials, of which 38, or 4.4%, constituted quality-of-life assessment measures.

 

The relatively low use of such tools may be surprising in the context of several studies highlighting the importance of capturing patient reported outcomes. The research team comment in their report that ”the same emphasis should be assigned to quality of life (QoL) in AMD RCTs as in other chronic diseases or cancer trials where cure is also often impossible to achieve.” Several explanations for why quality-of-life outcomes are not more regularly collected include an under-estimation by professionals and regulators regarding the difficulties experienced by AMD patients, or a misunderstanding between what visual acuity measures and what quality-of-life outcomes measure. In summarizing their conclusions the research group commented, “we demonstrated that PROMs (patient reported outcome measures) are not often used in AMD trials. If using PROMs was a common practice in AMD RCTs, then an assessment of interventions would be more holistic, addressing issues derived from a patient’s standpoint.”

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