The sinus surgical wait list in British Columbia continues to grow. The current wait list
is beyond what is acceptable by the province's standard; however, this is not likely to
improve given the budget constraints of the health care system. The outcome of having
patients to wait longer than medically reasonable for surgery, not only affects the
patients' quality of life but presents financial difficulties, both directly to the
patient, the healthcare system and the economy as a whole. Therefore, the investigators
need to determine which patients need to be prioritized for surgery. The investigators
will follow two groups of patients - one group from Stanford University who get surgery
always before 8 weeks and compare them to patients on the VGH wait list which is often
more than one year.

Early Versus Late Surgical Wait Times

Rhinosinusitis

Introduction Five percent of Canadians suffer from Chronic Rhinosinusitis (CRS) based on
a national survey.1 CRS sufferers have debilitating facial pain, nasal congestion, nasal
discharge and poor sense of smell. Relative to other chronic diseases, the quality of
life of patients suffering with CRS is comparable to diseases such as congestive heart
failure, chronic obstructive pulmonary disease, angina and back pain.3 Currently, CRS
patients in Vancouver, British Columbia wait just over a year for surgery. British
Columbia's (BC) health care policy recommends that CRS patients waiting for surgery be
done in twelve weeks. It is well recognized that patients who wait longer than medically
reasonable for surgery result in an excess costs, both directly to the patient, the
healthcare system and the economy as a whole.5 Unfortunately, no studies done in Canada
have illustrated the direct and indirect costs associated with CRS annually.

Patients' waiting time for elective sinus surgery in BC has come under public scrutiny in
recent years. As a result, policy-makers are keen to address this waitlist issue.4 The
government has identified sinus surgery as an elective day procedure that requires the
Patient Focused Fund (PFF) to increase volume and address its disproportionately large
waitlist. This likely has resulted in savings to VCH patients and the BC Health Ministry
that would not have occurred had the PFF not been initiated. However, policy-makers must
explore other innovate ways to supplement the PFF to provide further savings to VCH
patients and the BC health care system.

An approach that has been adopted by other specialities such as orthopaedics,
ophthalmology, and radiology is the use of a validated tool to prioritize waitlists.6-8
There are no validated tools published for prioritizing sinus surgery waitlists. The
Canadian Institutes of Health Research provided funding to establish the Western Canada
Waiting List Project (WCWL) to "improve the fairness of the health care system so that
Canadians' access to appropriate and effective medical services is prioritized on the
basis of need and potential benefit."9 Despite the work done by the WCWL being limited to
five clinical areas (cataract surgery; general surgery procedures; hip and knee
replacement; magnetic resonance imaging (MRI) scanning, and children's mental health),
the methodology utilized in establishing their prioritization tool can be used to
establish one for the sinus surgery waitlist;10 The impact of chronic diseases, including
CRS, varies among patients11; therefore, prioritizing patients based on clinical
measurements and cost-effectiveness from an individual and healthcare system perspective
would be a novel approach to addressing waitlists for sinus surgery. Currently, VCH CRS
patients are treated on a first come, first served basis. Despite this being the most
transparent way of ordering the waitlist, the investigators feel VCH CRS patients need a
waitlist system that promotes wellness and ensures care that focuses on quality - this
can be achieved with a prioritized waitlist based on quality of life improvement and
decreased healthcare expenditure.

Prior to establishing a validated tool for the prioritization of sinus surgery waitlists,
one must first determine if VCH patients and the BC health care system would benefit from
prioritized surgery. Providing a solution to this question requires moderate amount of
resources and would take several of years to complete. The investigators propose a
feasibility study coupled with an economic evaluation to determine if the
disproportionately long wait list faced by CRS patients can be optimized and thus improve
patient outcomes.

Current State of Knowledge Researchers must determine if CRS patients and the BC health
care system would benefit from a prioritized waitlist for sinus surgery. It is accepted
that sinus surgery compared to medical therapy improves the quality of life of CRS
patients.12-14 However, to determine whether VCH CRS patients would benefit from a
prioritized waitlist, the investigators must answer the following questions. If patients
were to have surgery sooner: 1) how does their quality of life change with time compared
to those on the waitlist? 2) do they experience a reduction in out of pocket costs?; 3)
does the healthcare system experience a decrease in healthcare expenditure? and 4) is
there are a subgroup of patients who would particularly benefit more than others from
early surgical intervention? Providing this information is vital in determining if a
prioritized waitlist would be beneficial for sinus surgery.

Patient Recruitment:

Recruitment of patients will occur at two centres. Patients classified as "prioritized
surgery" will be recruited from Stanford Sinus Centre, Palo Alto, California. Patients
classified as "standard waitlist" patients will be recruited from Vancouver General
Hospital, Vancouver, Canada. The PI will identify consecutive patients that fit the
inclusion/exclusion criteria and are being enrolled for sinus surgery. The study
coordinator (or designate) will discuss the study with the identified patients and allow
patients up to 7 days to provide consent.

On the day of consent:

A diagnosis of the patient's medical health will be conducted by the study investigators
and a Lund-Mackay and Lund-Kennedy score systems will be used to assess the patient's
chronic rhinosinusitis. Additionally, the state of the rhinosinusitis will be evaluated
on the day of consent and on every subsequent follow-up visit. A questionnaire relating
to demographics will be obtained as well (Appendix D).

Approach to Each Aim:

Aim 1: The investigators will compare how the quality of life of CRS patients change with
time when prioritized to early surgical intervention compared to those on the standard
waitlist.

All CRS patients participating in the study will fill in a disease-specific health
related quality of life instrument for CRS patients known as the Sinonasal Outcome Test
(SNOT-22) and two generic assessment of health status known as the WPAI-SHP and EQ-5D
(Appendix A) every 2 months for 1 year.

The study coordinator (or designate) will contact patients every 2 months via email and
provide them with a secure link to fill in each questionnaire. When questionnaires are
complete, they will be saved directly into their medical records.

Rationale for Questionnaires: The Sinonasal Outcome Test (SNOT-22) is a validated
questionnaire.16 SNOT-22 is a disease-specific health-related quality of life instrument
in CRS patients. The EQ-5D has 5 questions addressing: mobility, self-care, usual
activities, pain/discomfort, and anxiety/depression. The Work Productivity and Activity -
Specific Health Problem (WPAI:SHP) is a validated instrument to evaluate impairment of
daily activities and work productivity associated with a specific health problem (Chronic
Rhinosinusitis). The work productivity impairment domain is a sum of impairment in work
productivity due to absenteeism and due to decreased productivity while working
(presenteeism); this domain is assessed only in employed patients. The activity
impairment domain is assessed in all participants regardless of their employment status
and represents impairment in daily activities other than work.18 The investigators would
prefer to use an easy to administer generic health measure like the EQ-5D compared to the
WPAI-SHP, but during the feasibility stage, the investigators will administer both
questionnaires and at the completion of the study determine the most appropriate
questionnaire for this study.

Aim 2: To determine if patients prioritized to early surgical intervention experience a
reduction in out of pocket costs compared to patients on the standard waitlist.

All CRS patients participating in the study will fill in a questionnaire regarding
personal costs incurred over 1 year. To ensure the most accurate costs are tabulated,
patients will fill in this questionnaire every two months (Appendix B).

The study coordinator (or designate) will contact patients every two months via email and
provide them with a secure link to fill in questions from Appendix B similar to Aim 1.
The study coordinator (or designate) will follow the same protocol of contacting the
patient if the questionnaire is not filled in a timely manner. Patients can also complete
this Aim on a hard copy similar to Aim 1.

To ensure the investigators were inclusive of all the cost incurred by CRS patients, a
sample population of 30 VCH CRS patients were surveyed. Moreover, a panel that included
multiple Rhinologists and a Health Economist established questions that were pertinent to
costs incurred by the patient that may have been overlooked by the sample population.
This process ensures that the most accurate estimate of personal costs incurred by CRS
patients while waiting for surgery and those prioritized to early surgery. (Appendix B)
Aim 3: The investigators will determine if the Canadian health care system experiences a
decrease in healthcare expenditure if CRS patients are enlisted for early surgical
intervention versus patients on the standard waitlist.

When VCH CRS patients are addressing Aim 2, they will also have additional questions that
pertain to costs incurred by the health care system (Appendix B). The PI will fill in a
questionnaire regarding costs incurred by the health care system for 1 year for each
patient when there is a believed cost to the public system that is atypical compared with
expected costs (Appendix C). During each clinical for each patient, the PI will tabulate
the costs incurred during the patient's clinical visit.

Like in Aim 2, a panel consisting of multiple Rhinologists established Appendix C.
Moreover, during three clinical days by the PI, extra costs incurred by the VCH health
care system were noted and included into Appendix C.

Aim 4: The investigators will determine if there is a subgroup of CRS patients who would
benefit from early surgical intervention.

Stratification of VCH CRS patients and determining if patients benefited from early
surgical intervention will be established through demographic information, clinical
findings and comparison of outcomes obtained in Aims 1-3. Demographic information will be
obtained on the day consent is obtained (Appendix D). The PI will also complete a
standardized consultation/follow-up form for each visit to report clinical findings.

The PI will also complete a standardized consultation/follow-up form, including an
evaluation of healing subsequent to nasal surgery based on the Lund-Kennedy score, for
each visit to document clinical findings.

Analysis:

Pre-Study Sample Size Calculation - Sample size for comparison on average difference in
SNOT-22 scores between two equally sized group over time followed the Diggle et al
formula.19 Based on an effect size of 9 points15 between the early intervention and
standard waitlist patients, type 1 probability of 5% (α = 0.05), a type 2 probability of
20% (β = 0.20), standard deviation of 20 from pre- and post surgical values15 and 6
measurements of SNOT-22 over 12 months, the assumed correlation (p) will range from 0.75
and 1.00 if 124 to 156 patients are recruited, therefore allowing for a conservative
estimate of 10% drop-out.

Post-Study Completion - Aim 1 will be analyzed using 2-sample t-test. The investigators
will conduct a cost-utility analysis to evaluate Aims 2 and 3. the investigators assume
the cost of surgery for the early intervention group will be the same as those who will
receive in it on the standard waitlist; therefore, this cost will be removed from the
early intervention group. The economic model will evaluate costs and utilities (measured
by EQ-5D and WPAI-SHP) and calculate incremental cost-effectiveness ratios (ICERs). The
time horizon for this evaluation will be 1 year. No other discounting of costs or
utilities is required given this time horizon. Uncertainty around the ICERs will be
quantified using bootstrapping. Aim 4 will be analyzed using linear regression models.
The best-fit model will provide insight to sub-population of CRS patients who would
benefit from early surgical intervention.

Surgery wait time

Is Prioritization of the Sinus Surgical Waitlist Required?

Patient demographic information to be completed once after surgery to determine if there
is a distinct group of chronic Rhinosinusitis patients who would benefit from early
surgical intervention.

Personal costs related to surgical wait times.

The questionnaire WPAI-SHP relates to quality of life after surgery. The Work
Productivity and Activity - Specific Health Problem (WPAI:SHP) is a validated instrument
to evaluate impairment of daily activities and work productivity associated with a
specific health problem (Chronic Rhinosinusitis).

The questionnaire SNOT-22 relates to quality of life after surgery. SNOT-22 is a
disease-specific health-related quality of life instrument in CRS patients.

The questionnaire EQ5-D relates to quality of life after surgery. The EQ-5D has 5
questions addressing: mobility, self-care, usual activities, pain/discomfort, and
anxiety/depression.

Principal Investigator

Outcomes of patients with sinus surgery of less than 8 weeks.

Outcomes of patients with sinus surgery of more than 1 year.

Early Versus Late Surgical Wait Times

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status