Patient-centric periodontal research: A pioneering application of patient-reported outcome measures

Abstract

Conventional dentistry or periodontal research often ignores the human component in favor of clinical outcomes and biological causes. Clinical research is driven by the statistical significance of outcome parameters rather than the satisfaction level of the patient. In this context, patient-centric periodontal research (PCPR) is an approach that considers the patient´s feedback concerning their functional status, experience, clinical outcomes, and accessibility to their treatments. It is argued that data self-reported by the patient might have low reliability owing to the confounding effect of their personal belief, cultural background, and social and economic factors. However, literature has shown that the incorporation of “patient-centric outcome” components considerably enhances the validity and applicability of research findings. Variations in the results of different studies might be due to the use of different and non-standardized assessment tools. To overcome this problem, this editorial enlists various reliable tools available in the literature. In conclusion, we advocate that the focus of researchers should shift from mere periodontal research to PCPR so that the results can be effectively applied in clinical settings and the therapeutic strategy can also change from mere periodontal therapy to patient-centric periodontal therapy.

Key Words: Patient-centered care, Clinical research, Surrogate endpoints, Quality of life, Oral health, Patient reported treatment outcomes

Core Tip: Patient-centric periodontal research (PCPR), a ground-breaking idea, attempts to bridge the gap between science and patient well-being. Conventional dentistry or periodontal research often ignores the human component in favor of clinical outcomes and biological causes. The requirement for PCPR will lead to a paradigm shift in research that favors a comprehensive strategy that prioritizes patients and their experiences. A thorough understanding of how periodontal diseases affect people’s daily lives becomes feasible in PCPR because of the active patient participation in the study process. This can be done by incorporation of patient related outcome measures (PROMs). However, not only PROMs be standardized, but they should also undergo psychometric validation so that they can be reliably used in clinical research to improve the quality of treatment and enhance patient safety.

INTRODUCTION

One of the most prevalent diseases in the world is periodontal disease (PD), which is a chronic inflammatory condition that affects the tissues surrounding and supporting the teeth. PD has been shown to have a detrimental effect on the oral health-related quality of life (OHR-QOL)[1]. These effects may be due to bleeding from gums, mobile teeth, inability to chew, swelling in gums, excessive gingival display, foul smell from the mouth, etc.

In periodontal care, patient-centered outcome assessment is crucial as patients’ perspectives may differ from conventional clinical endpoints. Imagine yourself undergoing an expensive and painful surgery after which the treating doctor congratulates you that your treatment has been successful and that your disease score has reduced from level 6 to level 2 but you continue to experience the same problem that you had before the surgery. Will you consider it a successful therapy?

Surrogate endpoints, sometimes referred to as clinical or biological endpoints, are objective measurements that evaluate the viewpoint of the physicians regarding the illness or treatment. These endpoints include inflammation-related (reduced gingival bleeding on probing), microbiological (reduced periodontal microbiota before and after the treatment), immunological (assessment of gingival crevicular fluid biomarkers), and anatomic (probing depth, gain in clinical attachment level, and bone fill following periodontal therapy) measurements, which are intangible to patients.

Conversely, “true endpoints,” at times referred to as “patient-based outcomes” or “patient-reported outcomes,” are any reports of a patient’s state of health that originate from the patients themselves and are devoid of interpretations of the patient’s response by a physician or any other third party. These are subjective metrics that reflect the viewpoints of patients regarding the condition or treatment, such as decreased bleeding from the gingiva while brushing or eating, tooth mobility, discomfort, sensitivity to the teeth, foul breath, and increased chewing efficiency after periodontal therapy. For the patient, these goals are observable, which means that they may be mentally recognized or realized precisely. The subjective OHR-QOL indexes are the primary means of evaluating the genuine endpoints after periodontal therapy[2].

Self-reporting by patients is an easy, practical, and less expensive way to obtain firsthand data about treatment effectiveness. However, patients’ personal beliefs, cultural background, and social, educational, and environmental factors have a profound impact on these metrics. Studies[3,4] have indicated that self-reported periodontal status has low trustworthiness and predictive ability. Furthermore, participants’ reporting biases affect self-reported metrics. However, various tools or assessment criteria can be used to overcome this problem. “Patient-reported outcome measures (PROMs)” measures offer significant benefits when applied to evaluate the efficacy of periodontal therapy in clinical and research settings. A research priority in periodontology was determined during the 2003 World Workshop on Emerging Science in Patient-based Outcomes[5].

ASSESSMENT TOOLS

Table 1 enlists various tools used to assess PROMs evaluated by different researchers over some time. The choice of the most suitable instrument by the investigator depends on the objectives of the study and the feasibility of using the tool. Moreover, Oral Health Impact Profile (OHIP)-49, OHIP-German version, OHIP-4-s, OHQOL-Japanese version, Emotional Intelligence Questionnaire by Cooper and Sawaf, etc., are also available.

Table 1 List of various tools used to assess patient-centered treatment outcomes evaluated by different researchers over a period of time.

Sr. No.	Patient-centered outcome assessment measures	Instrument	Ref.
1	Euro Quality of Life-5 D	This tool assesses five dimensions: mobility, self-care, usual activity, pain/discomfort and anxiety/depression	Brooks[6] (1996)
2	Individual Well Being-Quality of Life	It is a broad notion that is intricately influenced by an individual's amount of independence, psychological condition, physical health, social relationships, and relationship to prominent environmental characteristics (World Health Organization, 1997)	World Health Organization[7] (1997)
3	Oral Health Impact Profile	This instrument has good validity, accuracy, and reliability. It was created to gauge how oral illness affected a person's well-being on a social level. Functional limits, physical pain, psychological discomfort, physical disability, psychological disability, social impairment, and handicap are the seven domains on which it operates	Araújo et al[8] (2010)
4	Oral Health-Related Quality of Life-United Kingdom	Constructed to capture the impact of oral health beyond the absence of disease. It has been used to study correlation between Oral Health-Related Quality of Life and periodontal disease	Nagarajan et al[9] (2012)
5	Oral Health Related Quality of Life	Provides information to support objective clinical criteria and describes the subjective experiences of patients with their dental health. Functional restrictions, orofacial pain, dentofacial aesthetics, psychosocial impact, and dental health are important factors	Hamedy et al[10] (2013)
6	General Oral Health Assessment Index	Measure patient reported oral functional problems like Visual Analogue Scale for pain assessment in Euro Quality of Life	Jönsson et al[11] (2014)
7	Patient-Reported Outcome Measure	Data can be gathered using an electronic or paper-based psychometric questionnaire that had been validated	Kyte et al[12] (2016)

Regardless of the means used to assess PROMs, the instrument used should meet the following criteria[13]: (1) Be free from error; (2) Be reliable; (3) Be able to measure what they are intended to measure or is valid; (4) Be sensitive to changes in the patient’s condition or be able to detect treatment differences; and (5) Be interpretable or clinically meaningful.

PROMs as a tool should be used to complement the clinical data and not replace it. A key challenge however is to select which PROM tool is more suitable for the condition under study. There is always a conflict in decision-making whether to use generic PROM or condition-specific PROM. However, it is recommended to use both concurrently at different levels of therapy and research to improve the quality of treatment and enhance patient safety. Assessing PROMs may help on an individual level as they facilitate the communication between the patient and the oral healthcare provider. However, PROMs may be a challenge for large-scale assessments.

According to the assessment of Shah et al[14], when the use of actual endpoints is not practical, surrogate endpoints can be utilized with caution. These may be used in phase 2 trial screening and assessment for novel, promising treatments. The outcomes of these studies can aid in deciding whether the intervention has the potential to justify the longer and larger-scale clinical trials that are conducted. Trials with real endpoints, which are more concrete and patient-centered, are required to substantiate this decision. Obtaining concrete proof of the impact of the intervention on actual clinical outcomes is the key objective.

Patient satisfaction, quality of treatment, patient safety, and patient-provider communication do seem to be enhanced by PROMs, but only if they are carefully designed, pertinent to patients, and well-verified.

CONCLUSION

We advocate that all possible efforts be taken to include the PROMs in future clinical research not only for the results obtained but also along the entire course of the research, right from sample selection and methodology to finally treatment and interpretation of the results. Thus, the focus should be gradually shifted from just periodontal research to PCPR.

The results obtained after the inclusion of patient-centric approaches may vary from those reported in historical studies primarily based on surrogate endpoints. Nonetheless, the results obtained by incorporating true endpoints in the form of PROM questionnaires can be successfully applied to the general population. The selected approach may not be ideal concerning the textbook or landmark articles but will make the patient happy and accept the therapy provided. Thus, the approach to patient care will not merely remain periodontal therapy but will be transformed into patient-centric periodontal therapy.