If you don't remember your password, you can reset it by entering your email address and clicking the Reset Password button. You will then receive an email that contains a secure link for resetting your password
If the address matches a valid account an email will be sent to __email__ with instructions for resetting your password
Despite a surge in interest in patient-centred outcomes (PROMs) in healthcare settings, they remain an underutilised resource in third molar surgery. Clinicians and researchers in the field of oral surgery interested in incorporating PROMs into their clinical practice may face challenges in instrument selection, with as yet no consensus registry available. PROMs have undoubtedly transcended their original brief as research instruments, with collection of PROMs data now a routine undertaking in many healthcare systems. Quality improvement, appropriate resource allocation and measurement of effectiveness of interventions are but a few of the advantages of PROMs data collection. This review article presents a scoping overview of those instruments most relevant to the third molar surgery population.
The role of the patient in establishing disease chronology and meaningful outcomes of surgical and pharmacological interventions, is now widely considered crucial in evaluating the quality of healthcare services, and should be seen as complementary to objective clinical outcome measures. This shift away from the traditional disease-centred approach to healthcare provision towards a more patient-centred ethos, has been lauded by some as transformative to healthcare services, and has prompted widespread implementation of patient-reported outcome measures (PROMs) in Sweden, England and the United States.
PROMs were originally developed for use in research, but have since been adopted by medical professionals to aid clinical decision-making, and to assess outcomes of treatment provision.
Policymakers may also look to PROMs data to inform funding decisions, prioritising patient groups deemed most in need of resources. PROMs are distinct from patient-reported experience measures (PREMs), which focus more on qualitative aspects of the humanity of care.
Mandatory collection and analysis of PROMs data was introduced by NHS England in April 2009 for a number of elective surgical procedures including hip replacement, knee replacement, inguinal hernia repair and varicose vein surgery, with four key aims in mind:
Research on effectiveness rather than efficacy of treatments
•
Establishment of baseline pre-operative health status of patients
•
Reduction of health inequalities
The Royal College of Surgeons in England (RCS Eng) also asks all providers of cosmetic surgery to routinely collect baseline and postoperative PROMs data for patients undergoing abdominoplasty, rhinoplasty, blepharoplasty, augmentation mammoplasty, liposuction and rhytidectomy. Collection of such data for this patient cohort is essential to truly appreciate the risk-benefit analysis of cosmetic surgery.
PROMs in oral surgery
Use of PROMs in oral surgery is not a novel concept. The first preliminary reports into the impact of third molar surgery on quality of life date back over twenty years, where researchers collected data from 29 patients on days 1 and 7 postoperatively.
The results of this study helped inform the design of a disease-specific third molar quality of life instrument, the postoperative symptom severity (PoSSe) scale,
This is particularly relevant in the current climate where National Health Service (NHS) operating lists are at an all-time high as a result of the Covid-19 pandemic. The “Clinical Guide to Surgical Prioritisation of Patients on Oral Surgery Waiting Lists” document published jointly by the British Association of Oral Surgeons (BAOS) and British Association of Oral and Maxillofacial Surgeons (BAOMS) suggests that surgical prioritisation may be a reality for up to 3 years.
The core oral surgery PROMs outlined in the NHS Commissioning Guide are reportedly based on NHS Classifications OPSC-4 and the WHO ICD10 Classification of Disease, since superseded by ICD11.
To date, only two studies have investigated the use of these core PROMs in an oral surgery patient cohort, one each in primary3 and secondary care10. In both cases, authors collected data for benchmarking purposes, generally garnering positive feedback from patients undergoing dental extractions at their respective institutions. While these core PROMs may play a role in crude service evaluation, they have no proven validity and reliability and are therefore of limited value in the broader context of patient outcomes in oral surgery. There is currently no agreed consensus on a core set of oral surgery PROMs, yet a need to expand the available repertoire of specialty and procedure-specific PROMs has been identified by the profession.
or the COnensus-based Standards for the selection of health Measurement INstruments (COSMIN). The latter defines nine measurement properties clustered within three domains. The evaluation process is essential to ensure available PROMs are robust and fit for purpose.
Third molar surgery remains one of the most commonly performed surgical procedures worldwide,
Such is the predictability of the associated sequelae that third molar surgery is one of the most popular research models for interventional studies. With ever more third molar studies appearing in the scientific literature, where does the aspiring researcher begin with respect to outcome measure selection? It goes without saying that outcome measures should be measurable, reproducible and meaningful for the target population. We previously explored trends in clinical outcomes (ClinRO) reporting in third molar surgery, and found that swelling and mouth opening/trismus are the two most frequently reported clinical outcomes by researchers.
It is not unreasonable to suggest that these numerical values are less meaningful than the impact they will have on patient function during the postoperative period e.g. chewing ability, speech etc. Which is where the role of PROMs in third molar surgery outcomes reporting comes into play.
A systematic review published in 2010 summarised the most commonly used QoL PROMs in the broader context of oral and maxillofacial surgery.
However, to our knowledge, no authors to date have published a summary of PROMs pertinent to third molar surgery. With this in mind, we aim to present those PROMs most widely reported in the third molar literature (Table 1), and hope this article will act as a useful aide memoire for interested clinicians and aspiring researchers.
Table 1Summary of commonly used PROMs in third molar surgery
Pain is among the most common complaints among patients following third molar surgery, and remains the most likely reason for patients to seek help postoperatively.
Pain has a protective function in the postoperative period by promoting undisturbed healing. For patients undergoing third molar surgery, the pain experience will restrict mouth opening thereby limiting function at the site of surgery and encouraging rest. Reduction of pain after oral surgery, rather than total elimination, is desirable to prevent a premature return to normal function, which might otherwise lead to wound damage and ultimately delayed healing.
Crucial to effective postoperative pain management is measurement of a patient’s pain intensity. The numerical rating scale (NRS), first described by Downie in 1978, consists of a linear 11-point scale with either a vertical or horizontal orientation (Fig 1). Patients are asked to rate their pain anywhere from 0 ‘no pain’ to 10 ‘worst pain imaginable’. Its advanatages are its simplicity, suitability for written and verbal administration, as well as its usefulness among patients whose native language is not English, overcoming any potential language barriers to pain measurement.
Its original application was in the assessment of pain in a cohort of 100 rheumatoid arthritis patients, where it was found to outperform the visual analogue scale (VAS) and ordinal descriptor scales.
Other studies have corroborated the superior responsiveness of the NRS compared to other unidimensional pain measuring instruments, and it is recommended as one of the best choices of instrument where sensitive measures of pain intensity are indicated.
The VAS is a 100mm linear scale that has been in use for over 80 years, and is administered in a horizontal or vertical format (Fig 2). It has verbal anchors at either end, “no pain” and “worst pain imaginable”, which represent a continuum of pain intensity.
Patients are asked to draw a single mark on the line to indicate their current level of pain. The distance from the “no pain” anchor to this mark is measured using a ruler, which corresponds to the pain score (ranging from 0 to 100). Although the horizontal VAS orientation is the preferred instrument format, its vertical counterpart tends to yield superior sensitivity.
Its disadvantages compared to NRS are the need to instruct patients on how to use the instrument to ensure accurate pain rating, and the potential for error when converting the marking to a numeric score. Furthermore, it must be administered in a written format if it is to be applied correctly, thus making it unsuitable for verbal administration.
The McGill Pain Questionnaire (MPQ) and its short form equivalent (SF-MPQ) document pain intensity as well as the sensory and affective dimensions of pain by using a series of verbal descriptors such as “throbbing”, “shooting”, “stabbing”, “sharp” and “cramping”.
The MPQ is one of the few instruments that can truly capture the multidimensionality of pain, but the level of respondent burden renders it an unlikely choice in third molar surgery cohorts where the more transient, inflammatory-type pain can be suitably captured using a simpler unidimensional instrument such as NRS or VAS.
Quality of life assessment encompasses a triad of physical, social and psychological parameters that must be documented preoperatively and postoperatively to be able to truly appreciate the impact of third molar surgery on patients’ QoL. A lack of baseline data is identified as a weakness of many QoL studies (Duarte-Rodrigues et al);
it is impossible to distinguish a positive impact from a negative one if baseline QoL data are not collected.
Evaluation of QoL in the third molar surgery population has transcended its original brief of application in research studies such as RCTs and cohort studies; it has helped shape what and how we communicate with patients considering third molar surgery. It should be borne in mind that ‘cure’ is often worse than ‘disease’ in the case of third molar surgery, and it is imperative that patients are appropriately and adequately informed during the decision-making process.
Disease-specific PROMs have the advantage of demonstrating greater face validity and credibility, while generic PROMs allow for comparisons across conditions.
It comprises a descriptive system of five dimensions and a vertical VAS denoting a patient’s self-rated health score at a particular point in time. Each of the five dimensions is scored on a three-point scale, representing ‘no problems’, ‘some problems’ and ‘extreme problems’. Subsequently EQ-5D-5L, with a novel five response level, was developed to address the potential for ceiling effects and concerns about the sensitivity of the 3L version for detecting clinically important differences in health-related quality of life.
With a response rate of 72% among their 50 patients, they reported good responsiveness of the EQ-5D-3L instrument. However, no baseline QoL data were captured and there were no objective outcome comparators to substantiate their findings. Based on this study alone, it is difficult to ascertain the suitability of EQ-5D-3L in this population.
The validity and sensitivity of the SF-12 in the context of third molar surgery have previously been investigated.
In their cohort of 100 patients awaiting removal of a single mandibular third molar under local anaesthesia, the authors found the generic SF-12 instrument was unable to distinguish high-need patients from those who were asymptomatic. They concluded that the SF-12 is not a valid measure of preoperative or postoperative health status in an oral surgery population. It did, however, demonstrate acceptable sensitivity in the immediate postoperative period, correlating well with oral health-related instruments.
Oral Health-Related
The Oral Health Impact Profile (OHIP) is by far the most widely used oral health measure in use today. It was originally developed as a 49-item (OHIP-49) instrument capturing seven conceptually formulated dimensions based on Locker’s theoretical model of oral health.
OHIP-49 has since been largely superseded by the short-form OHIP-14 designed to improve usability without compromising on psychometric properties. OHIP-14 shows superior discriminative validity compared to SF-12 in determining those patients most likely to benefit from third molar surgery.
Preoperative use of oral health measures such as OHIP-14 has been advocated as a screening mechanism to help identify patients most in need of third molar surgery.
The former is based on an updated WHO model of ‘structure-function-ability-participation’, and measures both positive and negative aspects of oral health across 16 domains of life quality.
There currently exists only one QoL instrument specific to third molar surgery with proven validity, reliability and sensitivity – the Postoperative Symptom Severity (PoSSe) Scale32 which has seven subscales: eating, speech, sensation, appearance, pain, sickness and interference with daily activities. While Ruta et al [
O'Sullivan L, Gallagher C, R NR. Effect of plasma rich in growth factors on quality of life following mandibular third molar removal: a double-blind randomized controlled trial. International journal of oral and maxillofacial surgery. 2022.
limitations in sample size (n=19) and an absence of psychometric testing fail to qualify the instrument as a valid measure of oral health-related QoL. The responsiveness of the PoSSe questionnaire has been demonstrated by numerous researchers, as well as a positive association between PoSSe scores and postoperative trismus and pain experience.
The superior responsiveness of the PoSSe instrument over the long-established SF-36 in the context of third molar surgery, together with its rigorous development protocol and psychometric testing, lend favour to its selection as the first choice of instrument for evaluation of the impact of third molar removal on a patient’s perceived health.
these qualities are further enhanced by the reproducibility of the PoSSe when used in third molar studies.
Psychosocial-specific
The Hospital Anxiety and Depression Scale (HADS) was developed to assess anxiety and depression in patients with illness, and in the general population.
It comprises 14 questions divided equally between two subscales: HADS-A (anxiety) and HADS-D (depression). It is recommended in the 2015 NHS Commissioning Guide for use as a routine oral medicine PROM, yet has never been validated for this purpose.
Nor has it been validated for use in a third molar surgery context. There are reports of HADS use in oral cancer patients undergoing tumour resection and reconstructive surgery, to fully evaluate depression and anxiety levels during the patient journey.
In this context, HADS scores can help determine whether patients are in need of additional psychological support during what can be an incredibly challenging time. It would seem reasonable to extrapolate HADS is best suited to patients with chronic illness, or for those with a protracted surgical journey.
Conclusion
Oral surgery lags far behind other dental specialties with respect to standardisation of outcome measures, despite a plethora of research in the field of third molar surgery in particular year on year. While equivalent dental specialties such as oral medicine and restorative dentistry continue to develop recommended core outcome sets (COS) as outlined on the publicly available COMET
(Core Outcome Measures in Effectiveness Trials) database, no such guidance yet exists for the oral surgery community. Considering the substantial contribution of third molar surgery to the oral surgeon’s workload, and the long established implications of third molar disease and surgery on quality of life, it would appear this is a missed opportunity for relevant stakeholders to fall into step beside other dental specialties.
As it stands, there is considerable heterogeneity in the methods of data collection in third molar cohort studies and clinical trials which can be attributed largely to a lack of standardisation of outcome measures available. Standardisation of clinical and patient-centred outcomes in the third molar population would facilitate the collection of high-quality data that could be merged for meta-analysis, and in turn, inform future clinical practice.
It is hoped this review article will go some way towards providing a source of reference for clinicians and researchers looking to incorporate PROMs into their clinical practice and clinical trials.
Declaration
The authors confirm there are no conflicts of interest to declare.
Conflict of interest
The authors confirm there are no conflicts of interest to declare.
References
Black N. Patient reported outcome measures could help transform healthcare. BMJ : British Medical Journal. 2013;346(jan28 1):f167-f.
O'Sullivan L, Gallagher C, R NR. Effect of plasma rich in growth factors on quality of life following mandibular third molar removal: a double-blind randomized controlled trial. International journal of oral and maxillofacial surgery. 2022.
00178-4&id=gr1.jpg){kind=link}
00178-4&id=gr2.jpg){kind=link}