Development of a patient reported outcome instrument for chronic sialadenitis

As medicine moves to embrace a more patient-centred approach to care, it is important to create and employ outcome measures which incorporate the patient perspective. The reality of healthcare today is that practitioners’ limited patient interactions do not allow for adequate exploration of the QoL burden of medical conditions. In surgical specialties, this reality means that the effectiveness of surgical procedures in alleviating the QoL burden imposed by chronic conditions may not be fully understood or evaluated by physicians. As such, outcome measures solely created based on the opinion of healthcare practitioners or objective assessments (imaging, and investigations, etc.) may not always provide the most comprehensive assessment of an intervention’s effectiveness in improving patients’ QoL [14]. Patient reported outcome measures present a unique opportunity to assess the extent of patient satisfaction with surgical interventions [15]. This is particularly useful for new surgical procedures such as sialendoscopy, as PROs can contribute to a patient centred cost–benefit analysis for widespread use of a new procedure.

Chronic Sialadenitis, characterized by inflammation of the salivary glands, is most often managed with conservative measures or extirpation surgery. Sialendoscopy provides intraluminal visualization of salivary ducts and assistance with minimally invasive surgical management of this condition. Current sialendoscopy literature uses clinician or researcher designed instruments to assess the patient reported outcomes of these minimally invasive treatment modalities [6,7,8, 10]. While these studies have shown symptom improvement following interventions, it is not possible to assess whether the domains captured by these instruments encompass the breadth of disease burden imposed by chronic sialadenitis. By creating a PRO instrument grounded in patients’ experiences and input, this study addresses the lack of patient-centeredness in current sialadenitis outcome measures. The use of a qualitative approach in the study design ensured that the final questionnaire was one which was grounded in patient experiences, perspectives, and common language. Furthermore, integration of a modified Delphi methodology allowed for the triangulation of data between all primary stakeholders (patients and practitioners) involved in this procedure, thus increasing internal validity of the results [16]. Finally, cognitive interviewing with patients in phase IV enhanced respondent validation [17] by ensuring that patients found the PRO questionnaire clear, relevant, and easy to read.

The final questionnaire (Table 5) captures patients’ experiences with sialadenitis related symptoms, activity restriction, and psychosocial burdens of disease. Questions have been grouped into three distinct subscales (as outlined in Table 1), which will allow clinicians and researchers to identify which area has the greatest impact on patients’ quality of life. These subscales may also provide clinicians with the ability to direct patient care and counselling to the greatest areas of concern. While categorization of questionnaire items allows for enhanced interpretation of patient responses, the questionnaire itself is not itemized in sequence based on these subscales. The current sequence of items in the PRO allows for ease of readability and understanding, as per participant feedback in Phase IV. Following completion of the questionnaire, patients will receive a total score, as well as a score associated with each subscale (Table 1). Questionnaire items with a binary response scale will receive a score of 0 for responses indicating a lack of symptoms, and 1 for symptom presence. Questionnaire items with a four- or five-point Likert-type scale will receive scores ranging from 0 to 4 or 0 to 5, with 0 corresponding to responses indicating the absence of symptoms.

Table 5 Patient reported outcomes questionnaire for sialendoscopy

Review of current literature reveals the use of clinician derived QoL questionnaires for assessment of the impact of chronic sialadenitis on patients’ lives, as well as treatment outcomes of sialendoscopy assisted procedures [6, 18]. Jokela et al. utilized the Health-Related Quality of Like instrument to assess the patient reported QoL benefits of Sialendoscopy assisted procedures [18]. While this 15-dimensional questionnaire is comprehensive in assessing various QoL domains, it encompasses symptoms (such as seeing and sexual activity) which are not conventionally associated with chronic sialadenitis and, based on the interviews conducted in this study, were not specifically mentioned by patients suffering from this chronic condition. Aubin-Pouliot et al. utilized the chronic obstructive sialadenitis symptoms (COSS) questionnaire to assess the impact QoL of sialendoscopy assisted procedures [6]. While this questionnaire focuses on sialadenitis specific symptoms, it was designed without the input of patients. Comparison of the COSS questionnaire with the PRO questionnaire described in this study reveals differences in wording and emphasis on certain QoL components (irritability, anxiety, and social interaction) which were selectively emphasized in our PRO questionnaire based on patient input and experiences. These differences highlight the importance of this study and directly incorporating patient experiences into the development of PRO instruments, as clinician perceived symptoms of concern may be different than those experienced by patients.

While this study’s contribution is unique in the field of sialadenitis and sialendoscopy, there remain some limitations to be explored. As with most qualitative studies, the issue of generalizability of this questionnaire remains to be tested19. While this tool is grounded in data generated from patient interviews, the opinions represent those of the patients sampled for this study. This does not account for potential differences in perception based on culture, age, or geography, with varying patient populations and a larger sample size. In future studies we plan to validate this instrument by administration to a large cohort of chronic sialadenitis patients. The prospective sample will include patients from varying demographic backgrounds and underlying etiology of disease (sialolithiasis, autoimmune disease, etc.…). Large scale validation will allow us to assess each item of the questionnaire based on the number of responses and nature of patient responses. Lastly, the potential for researcher bias proved challenging to mitigate in this study design, as the researcher is the primary instrument used to collect and analyze data. An attempt to lessen the potential for researcher bias was through the use of triangulation and various methods of data collection and interviewing—utilizing individual interviews, as well as focus groups.

留言 (0)

沒有登入
gif