Early Versus Late Surgical Wait Times

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.

Inclusion Criteria:

- Patients diagnosed with CRS based on 2 major symptoms (congestion, facial pain, nasal
obstruction, nasal discharge, decreased sense of smell) and evidence of sino-nasal
inflammation on CT scan and nasal endoscopy. Symptoms must also be present for >12
weeks.

Exclusion Criteria:

- History of or requiring surgery for a sino-nasal tumour