World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: a systematic review of outcome domains for salivary hypofunction.

OBJECTIVE: To identify all outcome measures used to assess salivary gland hypofunction (i.e., objective measures used to determine actual changes in saliva quantity or to assess response to treatment of salivary gland hypofunction) and to group these into domains. STUDY DESIGN: A systematic review including clinical trials and prospective or retrospective observational studies involving human participants with dry mouth, with any type of intervention where the objective assessment of salivary gland hypofunction was described. RESULTS: Five hundred fifty-three studies involving 31,507 participants were identified. Most assessed salivary gland hypofunction and xerostomia (68.7%), whereas 31.3% assessed salivary gland hypofunction alone. Most studies investigated the "amount of saliva," and the highest number of outcome measures were within the domain of "clinical/objective signs of salivary gland hypofunction." CONCLUSIONS: Seven domains encompassing 30 outcome measures were identified, confirming the diversity in outcomes and outcome measures used in research regarding salivary gland hypofunction. Identified items will be used in conjunction with those identified regarding xerostomia to create a core outcome set for dry mouth quantification for use in future clinical trials, with the overall goal of improving the standardization of reporting, leading to the establishment of more robust evidence for the management of dry mouth and improving patient care.

World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: a systematic review of outcome domains for xerostomia.

OBJECTIVE: The purpose of this study was to identify all outcome domains used in clinical studies of xerostomia, that is, subjective sensation of dry mouth. This study is part of the extended project "World Workshop on Oral Medicine Outcomes Initiative for the Direction of Research" to develop a core outcome set for dry mouth. STUDY DESIGN: A systematic review was performed on MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials databases. All clinical and observational studies that assessed xerostomia in human participants from 2001 to 2021 were included. Information on outcome domains was extracted and mapped to the Core Outcome Measures in Effectiveness Trials taxonomy. Corresponding outcome measures were summarized. RESULTS: From a total of 34,922 records retrieved, 688 articles involving 122,151 persons with xerostomia were included. There were 16 unique outcome domains and 166 outcome measures extracted. None of these domains or measures were consistently used across all the studies. The severity of xerostomia and physical functioning were the 2 most frequently assessed domains. CONCLUSION: There is considerable heterogeneity in outcome domains and measures reported in clinical studies of xerostomia. This highlights the need for harmonization of dry mouth assessment to enhance comparability across studies and facilitate the synthesis of robust evidence for managing patients with xerostomia.

World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: a consensus study.

OBJECTIVE: This study aimed to develop a consensus-based core outcome set (COS) to be used in clinical trials assessing dry mouth interventions. STUDY DESIGN: Through 2 systematic literature reviews and interviews with dry mouth patients, we identified relevant outcome domains for dry mouth assessment. A Delphi survey was presented to health care providers attending the American Academy of Oral Medicine annual meeting in Memphis, Tennessee, USA, on May 2022 (n = 104) and 10 dry mouth patients at Cork University Dental School and Hospital, Republic of Ireland. The outcome domains for which no consensus was reached were subsequently discussed in a second consensus process led by a virtual Special Interest Group of 11 oral medicine experts from the World Workshop on Oral Medicine VIII dry mouth working group. RESULTS: After the 2-step consensus process, a consensus was reached for 12 dry mouth outcome domains (i.e., salivary gland flow, signs of hyposalivation, mucosal moisture/wetness, the severity of xerostomia, duration of xerostomia, the overall impact of xerostomia, impact on physical functioning, impact of hyposalivation on general health, impact on social activities, quality of life, the economic impact of dry mouth, patient satisfaction) to be included in the final COS. CONCLUSIONS: We propose a consensus-based COS to assess dry mouth interventions in clinical trials. This COS includes the minimum but mandatory set of domains that all clinical trials evaluating dry mouth treatments should assess.

World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: the patient perspective.

OBJECTIVE: We conducted a qualitative study of patients' perspectives on dry mouth outcomes to explore their personal experiences and investigate which outcomes are most important to them. This work was part of the WONDER initiative (World Workshop on Oral Medicine Outcomes Initiative for the Direction of Research) exploring Core Outcome Measures in Effectiveness Trials. STUDY DESIGN: Using a study-specific topic guide, we conducted digitally recorded, semi-structured interviews of focus groups of patients with dry mouth secondary to Sjögren syndrome and head and neck radiotherapy. We conducted interviews until data saturation had been achieved and evaluated all transcripts for accuracy before we anonymized the data. RESULTS: Two focus groups consisting of 4 participants per group identified 4 distinct themes: (1) impact on oral health and function, (2) social isolation and withdrawal, (3) frustration with dry mouth management, and (4) limited knowledge of the medical community and lack of understanding of family and friends. CONCLUSIONS: The diversity of self-reported outcomes and the complexity of patient perceptions identified in our work may represent additional barriers to successful dry mouth management that should be considered in the design of future clinical trials.

Paediatric dentistry trainee views on training relating to the medically compromised child and oral medicine elements of specialty training curricula.

INTRODUCTION: Paediatric dentists care for children who are medically compromised and with an orofacial disease; therefore, trainees need appropriate training in these areas. The prevalence of congenital and chronic diseases in children is increasing, and future specialists need an understanding of human health and disease and oral medicine. This study aimed to determine if current teaching and assessments were fulfilling these requirements. MATERIALS AND METHODS: A survey distributed to the UK and Ireland specialty trainees asked their opinions on whether knowledge gained prior to entering training, and teaching and learning during training equipped them for future management of medically compromised children and those with oral medicine diagnoses. RESULTS: The response rate was 51% (26 trainees). Most were aware of curriculum elements for medically compromised children and oral medicine. The majority felt that knowledge and experience gained as undergraduates and early graduates was insufficient and recognised the need for these topics in speciality training. For medically compromised children, this learning was considered a good use of time by 96% of trainees, and 88% felt that this topic should be given more attention. For oral medicine, this learning was considered a good use of time by 96% of trainees, and 69% felt that this topic should have more attention. CONCLUSION: Paediatric dentistry specialty trainees recognise that knowledge and experience of managing patients considered medically compromised and those with oral medicine conditions are an important part of training and need greater emphasis, especially in light of changing demographics with congenital and acquired chronic disease, and children with oral medicine disorders.

Consolidating human disease learning in the Dental Emergency Clinic.

INTRODUCTION: Dental undergraduates typically learn and are assessed on aspects of human disease (HD) in the early part of their programme, but it is not until later in the programme that their HD knowledge is put into practice when they provide courses of treatment for numerous patients over multiple visits. The teaching of HD provides core knowledge on medical conditions and medications and is therefore essential in allowing newly graduated dentists to provide safe treatment for medically compromised patients or those taking medications. We wanted to examine the medical complexity of patients attending a university hospital dental emergency clinic to determine whether this was a suitable group that would help students to consolidate their HD learning in the context of a single visit where treatment was also provided. MATERIALS AND METHODS: We examined the medical history of 200 patients attending the dental emergency clinic in the University Dental Hospital, Cardiff, using a previous study as a benchmark. Anonymous data were collected using the medical history proforma, and included age, gender, medications, types and number of medical conditions/disorders. RESULTS: Patients attending the clinic were more medically complex than those in the comparator study and the demographics reflect wider population data showing increasing numbers of older patients with greater medical morbidity. DISCUSSION/CONCLUSIONS: The emergency dental clinic is the place where most patients are new to the hospital, have a dental history, medical history, investigations, diagnosis and treatment in a single visit, and offers excellent opportunities for consolidating HD learning in a one-stop clinical treatment episode, guided by suitable instructors.