Clinical trial NCT01419886: Testing of a New Scale Measuring Medical Outcomes of Dysphagia (MOD) in Adult Patients With Swallowing Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Canadian Cancer Society (CCS)
First posted: 2011-08-18
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients and outpatients of the University Health Network who have a diagnosis of dysphagia.

Brief summary: Swallowing disorders (dysphagia) are common in adult patients. There is emerging evidence that dysphagia itself can cause adverse medical outcomes. There is a three-fold increased risk for pneumonia in these patients versus similar patients without dysphagia. Patients with dysphagia also suffer poor nutrition and dehydration. Patients can become so malnourished that it slows their recovery. Dysphagia can cause choking when food or liquid enters the lungs. Over time, this will cause pneumonia and even death. More acutely, patients fear that their choking will cause them to suffocate and die. Over time, patients are embarrassed to be seen choking and thus feel forced to dine alone. These patients report feelings of isolation and depression. To date, there are no practical methods to assess these adverse outcomes of swallowing difficulties in patients. This research will be the first to address this gap. Specifically, as part of previous research (PhD dissertation by RM, the PI) a new measure of medical outcomes of dysphagia was developed, titled the Medical Outcomes of Dysphagia (MOD) scale. The MOD consists of 3 subscales that each measure lung, nutrition-hydration or psychological consequences in patients with swallowing difficulties. Unlike more expensive and complex tests, the MOD has been designed for both in- and outpatients. This research will validate each MOD subscale to ensure retention of only items that are reliable and valid for use with patients who have dysphagia due to any disease etiology. The final MOD subscales will be the first to allow clinicians to track medical complications in their patients and to ensure that treatment is effective. Globally, the MOD subscales will direct limited health care resources to the most effective treatments for swallowing disorders.


Eligibility criteria: Inclusion Criteria:

* Adult (18+ years)
* Any disease etiology, including but not limited to: previous or current diagnosis of head and neck cancer (treatment may include surgery, radiation or chemotherapy, or a combination of more than one), stroke, cervical spine abnormality, brain tumour, cardiovascular surgery, and Parkinson's disease
* Current diagnosis of dysphagia, as determined by a speech language pathologist
* English-speaking

Exclusion Criteria:

* No dysphagia
* Cognitive impairment
* Limited fluency in English

Primary outcomes:
measure: Reliability of the MOD subscales
timeFrame: 24 hours
measure: Validity of the MOD subscales
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University of Toronto / University Health Network
name: Rosemary Martino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martino R, Beaton D, Diamant NE. Perceptions of psychological issues related to dysphagia differ in acute and chronic patients. Dysphagia. 2010 Mar;25(1):26-34. doi: 10.1007/s00455-009-9225-0. Epub 2009 Aug 6.
citation: Martino R, Beaton D, Diamant NE. Using different perspectives to generate items for a new scale measuring medical outcomes of dysphagia (MOD). J Clin Epidemiol. 2009 May;62(5):518-26. doi: 10.1016/j.jclinepi.2008.05.007. Epub 2008 Aug 22.