Patient-centered assessments: how can they be used in dental clinical trials?

Abstract

Recently, there has been greater interest in adopting a more holistic approach to healthcare. However, this trend should not limit itself merely to the notion that a human being lies behind the mouth being treated. Rather, it should embrace the understanding that this human can actively participate in and contribute to the treatment process. Patient Report Outcome Measures (PROMs) and Patient Report Experience Measures (PREMs) provide means for measuring data from the patient's perspective, and enable health-related feelings and functions to be evaluated. Accordingly, this critical review aims to provide definitions, rationales and applications of patient-centered approaches in dental clinical research. Some patient-centered constructs are especially relevant to dental clinical trials, such as oral healthrelated quality of life, pain/discomfort, aesthetics and satisfaction concerning treatment and services. The selection and application of patient-reported measures can vary according to condition (generic, disease-specific or treatment-specific) and to the specific population evaluated (age and cognitive impairment). These measures can help weigh risks and benefits, as well as assess the cost effectiveness of treatments, thus influencing treatment recommendations and health policies. The incorporation of these measures into a professional's daily life not only represents an improvement in professional performance, but also addresses a humanitarian concern.

Impact of traumatic dental injury treatment on the Oral Health‐Related Quality of Life of children, adolescents, and their family: Systematic review and meta‐analysis

“…This is important for practice since these measures can help weigh risks and benefits, as well as assess the cost-effectiveness of treatments, thus influencing treatment recommendations and health policies. 39 Although numerous articles on OHRQoL and TDI have…”

“…been published, only a few address the treatment, suggesting that more studies with an effective methodology for answering the question proposed in this systematic review should be done. The incorporation of these measures into a professional's daily life not only represents an improvement in professional performance, but also addresses a humanitarian concern 39. …”

Can bulk-fill resin restorations be an alternative to resin-modified glass ionomer cement restorations in primary molars of toddlers? A randomized clinical trial protocol.

“…16 Patient-centered outcomes provide means for measuring intervention benefits/risks by evaluating concepts related to how patients feel or function with respect to their health, giving patients a voice in research and health services. 32 Post-operative sensitivity is an interesting patient-centered outcome to be evaluated in this protocol, since it is expected in patients undergoing restorations, mainly in bulk-fill composite resin, although there is still no scientific evidence on this subject. The B-DDQ 25 has already been used to measure children's discomfort after dental procedures 33 and, therefore, it is believed that it will be possible to detect differences, even if slight, between the restorative procedures.…”

Clinically relevant outcomes in dental clinical trials: challenges and proposals

“…Therefore, these types of outcomes are also called patient-reported outcome measures (PROMs), and they will be discussed in depth in another paper of this supplement. 15 Although CROs are more meaningful for the patients, most objective CROs in Dentistry require many years to manifest and the number of events is usually low. Thus, they are frequently replaced by surrogate outcomes, in order to reduce sample size, length of follow-up and the costs of the trial.…”