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This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in Ontario.
First, investigators will validate health administrative data codes to demonstrate the accuracy of Ontario-wide anesthesia type and regional anesthesia interventions using a reference standard (Ottawa Hospital Data Warehouse data). Then, these validated exposures, in combination with validated outcome measures, will be used to examine the impact of anesthesia interventions on patient and health system outcomes for ambulatory shoulder surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isolated General Anesthesia | Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have not had a nerve block identified using physician billing codes. |
| |
| Peripheral Nerve Block | Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have a nerve block identified using physician billing codes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isolated General Anesthesia | Procedure | No nerve block identified through physician billing codes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Death, Admission, Readmission or Emergency Department Visits | Composite outcome of: 1) unplanned admissions on the day of surgery , 2) post-discharge emergency department visits within 7 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause | Date of surgery to 7 days (ED visits) and 30 days (readmissions) after surgery or death date, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| Health System Costs | Costs in Canadian dollars will be calculated using standardized patient-level costing algorithms. | Date of surgery to 7 days and 30 days after surgery or death date, whichever came first |
| Neurology Consultations or Diagnostics |
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Inclusion Criteria:
Exclusion Criteria:
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This will be a retrospective, population-based, cohort study based in Ontario, Canada. Our study population will include all Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery. The study period extends from April 2009 to March 2016.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel McIsaac, MD, MPH | Department of Anesthesiology and Pain Medicine, University of Ottawa, Ontario, Canada | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Isolated General Anesthesia | Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have not had a nerve block identified using physician billing codes. Isolated General Anesthesia: No nerve block identified through physician billing codes |
| FG001 | Peripheral Nerve Block | Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have a nerve block identified using physician billing codes. Peripheral Nerve Block: Nerve block identified through physician billing codes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Isolated General Anesthesia | Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have not had a nerve block identified using physician billing codes. Isolated General Anesthesia: No nerve block identified through physician billing codes |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Death, Admission, Readmission or Emergency Department Visits | Composite outcome of: 1) unplanned admissions on the day of surgery , 2) post-discharge emergency department visits within 7 days of surgery, 3) readmission within 30 days of surgery, and 4) death from any cause | Primary analysis | Posted | Count of Participants | Participants | Date of surgery to 7 days (ED visits) and 30 days (readmissions) after surgery or death date, whichever came first |
|
AEs were not collected
AEs were not expected or collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Isolated General Anesthesia | Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have not had a nerve block identified using physician billing codes. Isolated General Anesthesia: No nerve block identified through physician billing codes |
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There is risk of misclassification bias. Confounding bias may influence receipt of specific interventions and outcomes. We were unable to measure patient-reported outcomes. Cost were captured at the health system level, but were not adequately granular to capture operating room supplies. We did not have specifics of each nerve block technique that may impact nerve block.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel McIsaac | The Ottawa Hospital | 613-761-4940 | dmcisaac@toh.ca |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007070 | Immunoglobulin A |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Peripheral Nerve Block | Procedure | Nerve block identified through physician billing codes |
|
|
Occurrence of neurology consult and/or nerve conduction study
| Date of surgery to 90 days after surgery or death date, whichever came first |
| Peripheral Nerve Block |
Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have a nerve block identified using physician billing codes. Peripheral Nerve Block: Nerve block identified through physician billing codes |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Surgery Type | Count of Participants | Participants |
|
| Surgery Type | Count of Participants | Participants |
|
| Neighbourhood Income Quintile | Neighborhood socioeconomic status of the participants is presented as income quintile (income quintile is a measure of neighbourhood socioeconomic status that divides the population into five income groups (from lowest income to highest income)). The scale is from 1-5 (income group quintile 1 (lowest), 2, 3, 4, 5 (highest)). The groups are based on where 20% of the population falls within each category and therefore values vary by year. | Median | Inter-Quartile Range | Neighbourhood income quintile |
|
| Rural | Count of Participants | Participants |
|
| Healthcare resource use | Count of Participants | Participants |
|
| Peripheral Nerve Block |
Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have a nerve block identified using physician billing codes. Peripheral Nerve Block: Nerve block identified through physician billing codes |
|
|
| Secondary | Health System Costs | Costs in Canadian dollars will be calculated using standardized patient-level costing algorithms. | Posted | Mean | Inter-Quartile Range | Canadian Dollars | Date of surgery to 7 days and 30 days after surgery or death date, whichever came first |
|
|
|
| Secondary | Neurology Consultations or Diagnostics | Occurrence of neurology consult and/or nerve conduction study | Posted | Mean | Standard Deviation | Visits | Date of surgery to 90 days after surgery or death date, whichever came first |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Peripheral Nerve Block | Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have a nerve block identified using physician billing codes. Peripheral Nerve Block: Nerve block identified through physician billing codes | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |