Background: when evaluating patient status, it is important to have the ability to measure the impact of different interventions or exposures from a patient perspective. Patient reported outcome measures (PROMs) represent those outcomes that, without having a clinician or an unnecessary proxy as intermediary, reflect the patient experience or perspective and are directly reported by the patient. In relation to the evaluation of unintended facial sensory alterations consecutive to oral and maxillofacial surgery (OMFS) procedures, it is not uncommon to see in the literature that types of outcomes other than PROMs are prioritized, and described as 'truly objective', disregarding the value of PROMs. There is inconsistency and uncertainty regarding what is the potential value of PROMs when evaluating the impact of facial sensory alterations followed after OMFS procedures.
Objective: to assess the completeness of reporting of PROMs in studies evaluating facial sensory alterations consecutive to OMFS procedures, with a special emphasis on health-related quality of life and measures of the magnitude of the sensory impairment.
Methods: we searched MEDLINE, Embase, Web of Science, the Cochrane Library, EBSCO, Scopus, CINAHL, Lilacs, and Scielo until November 2018, to identify primary studies evaluating facial sensory alterations in OMFS, and the reporting of PROMs. A pair of review authors independently screened citations at title and abstract, and full-text level for eligibility. Data extraction included the identification of any PROM reported, checking for further evidence of the PROM nature of the outcome by using the E-Provide database (eprovide.mapi-trust.org/) and any evidence reported of their measurement properties (validity, reliability, and responsiveness). In addition, we collected information regarding the nature and reason for the sensory alteration and participants’ demographics.
Results: out of 2828 citations reviewed, 375 were selected for full-text screening, and 35 studies proved eligible. The most common PROMs used were the visual analogue scale (VAS), the Hospital Anxiety and Depression Scale (HADS), the Oral Impact on Daily Performance (OIDP), the Oral Health Impact Profile (OHIP-14) and the version of that same instrument including 49 items (OHIP-49). It was important to note that the cited instruments were used beyond the scope of their construct or intended purpose. Citations or evidence of measurement properties of the PROMs were infrequently reported.
Conclusions: we identified substantial inconsistency as to whether PROMs were included when evaluating facial sensory alterations, and when positively included, which PROMs are expected to be used in primary studies. Such inconsistency and reporting limitations prevent systematic review authors and other researchers from effectively assessing the impact of facial sensory alteration from a patient perspective.