appendix l master variable list lumbar module ... · scoliosis o moderate (25 to 50 degrees) o...

Appendix L Master Variable List – Lumbar Module

Miscellaneous Info

Please keep in mind that MSSIC attempts to abstract data in a similar way across the Collaborative using several very different types of medical records, and from several different surgeons who undoubtedly dictate notes differently. Each abstractor along with his or her Surgeon Champion(s) should examine the medical record used and determine the best document(s) to abstract from. While the Coordinating Center attempts to provide guidance with a suggested source document list, the list may not be relevant at all sites. It is not necessary to use “Care Everywhere” notes or some other medical record file-sharing platform for the Exclusion, Inclusion or History tabs, but if access is available to the abstractor those notes should be checked for information that can be included in the Procedure and Admission tabs. When a medical record platform such as Care Everywhere has been relied upon, this should be documented in the Crosswalk or on a chart abstraction cheat sheet/note lest a patient rescind permission therefore rendering the documentation unavailable on audit.

KEY TO SUGGESTED SOURCE DOCUMENTS (use to interpret abbreviations found in the “Suggested Source Documents” column of this Master Variable List)

Abbreviation Source Document

Adm Anes AntmO Chart Review Cons DsSum ER Flw Ch H & P MedAd Off Nt Op Nt Path PreOp Prog Radiol Srg Sch SurgBd Tele VTEPr

Preadmission/Admission forms for surgical stay Anesthesia Report Antimicrobial Orders As it sounds – look through chart for appropriate documentation Surgeon’s Consult Note Discharge Summary Emergency Department documentation Flow Chart documentation for the Post-Surgical Hospital Stay History and Physical Medication Administration Record Office Note Operative Note Pathology Report Preoperative Notes Progress Note Radiology Report Surgical Schedule – Department or Facility Surgical Boarding Form Telephone Encounter VTE Prophylaxis Order or Form

Appendix L, of 68 Updated May 20, 2016

Appendix L – Master Variable List – Lumbar Module Miscellaneous Info

STATUS (found in “header” of patient record in the registry website and used in to indicate the status of the overall record for prompting of appropriate “Tasks”)

Question Answer Options: Definitions/Clarifications

Status O Patient active O Patient declined to participate, data abstraction allowed O Patient deceased O Patient returned for subsequent surgery - discontinue patient-provided data entry O Surgery cancelled O Excluded

If a patient declines to participate there may be a difference of opinion among individual IRBs as to whether or not chart abstraction for quality improvement is still allowed. Please use whichever is appropriate for your site and continue or discontinue as indicated. The software will stop giving you tasks where appropriate but will not prevent data entry. Tasks will branch accordingly when Status is changed.



Tab Name: ADD PATIENT/PATIENT INFO

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Answer Options: Definitions/Clarifications

Registry ID All inpatient and outpatient lumbar and cervical spine surgeries are potentially eligible and are entered into the registry using the "Add Patient" screen. Exclusion and further inclusion criteria will be addressed on the "Screening" tab. If this is a new patient, leave this field blank. A new Registry ID will be automatically generated. If this is a returning patient see sections 2 and 3 of the Manual of Operations for instructions.

Patient Initial Enter the last letter of the last name. Smith = "H"

Date of Birth The date of birth appearing in the medical record for this patient (MM/DD/YYYY).

Tracking ID (auto calculated)

(Auto-calculated - Derived from combining last letter in last name + 6-digit birthdate)

Use this as an additional identifier in your cross-walk database to confirm identity.

City The city in which the patient resides based on their primary home address.

Zip Code The 5-digit zip code for the patient's primary home address. NOTE: This field will also accept Canadian zip code entries.

Scheduled Surgery Date The date on which the patient is scheduled to have surgery based on the surgical schedule. If this patient is being rescheduled and a baseline questionnaire has been obtained already, leave the originally scheduled surgery date intact so that the baseline questionnaire is reflected as being within the appropriate window. If this patient is being rescheduled and no baseline has been obtained (especially when it is intended that the baseline questionnaire be done by the patient through the web portal) then this date may be changed to prevent expiration of emails and show collection of questionnaire within appropriate window.

Age (auto calculated) This field is auto-calculated by the program based on the Date of Birth and the Scheduled Surgery Date.

Hospital Name Where Surgery Performed

Select the hospital where the surgery is performed.

Surgeon Name (ID) Select the name of the surgeon.


Appendix L -Master Variable List – Lumbar Module Tab Name: Add Patient/Patient Info

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Tab Name: EXCLUSION

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MSSIC Patient Exclusion The following situations will exclude a scheduled surgery from the MSSIC registry. Please Check all that apply:

O Patient is under 18 years of age O Patient is incarcerated O Patient’s medical records or documentation are not available, cannot be accessed

Check all that apply in this category. A more detailed explanation of exclusion criteria and a list of the exclusion ICD-10 Diagnosis Codes appears as Appendix A of the Manual of Operations. Please remember to review the medical record for all exclusion criteria. For example, do not rely on a primary code added to a surgery schedule by a scheduler. NOTE: Hospitals with pediatric departments are not required to enter and then exclude all pediatric cases. Handle these similar to “thoracic” cases which are not within the scope of MSSIC.

Scoliosis O Moderate (25 to 50 degrees) O Severe (>50 degrees)

Moderate" or "severe" scoliosis as noted, by word or value, on radiology report or consultation note, with or without an ICD-10 Diagnosis Code assigned, is an exclusion criterion. Indicate degree of severity here. If scoliosis is an incidental finding (not the reason for surgery) and no one has thought it significant enough to document that it is moderate or severe, then we assume that it is mild and we include. If it is difficult to determine between “moderate” and “severe” indicate “severe” here. If scoliosis is indicated as “mild to moderate” the preference of MSSIC is that the surgeon make a call on whether it is mild or moderate. However, if it is not possible to obtain a definitive answer from the surgeon, the “mild to moderate” case should be excluded as “moderate”. MSSIC would rather inadvertently exclude an occasional mild case than allow introduction of moderate cases into the registry. Since moderate to severe scoliosis curvatures located anywhere in the spinal column complicate surgical outcomes, patients are excluded regardless of the proximity of the scoliosis curvature to the surgical site. Any case that had previous surgery to correct an excluded condition such as moderate/severe scoliosis or spondylolisthesis should not be considered for inclusion. The terms levoconvex and dextroconvex curvature, and levoscoliosis are acceptable as documentation of scoliosis.


Appendix L - Master Variable List – Lumbar Module Tab Name: Exclusions

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ICD Diagnosis Codes O ICD-10 diagnosis codes Choose the format of the codes being entered.

Enter appropriate diagnosis codes

See Codes as listed in the Manual of Operations Appendix A, A1 and in the FAQ document.

Check all codes that apply which represent the reason for exclusion. The codes as listed cover primarily the following categories: O Tumor (spinal) O Meningitis O Pre-existing spinal infection related to surgery O Other disorders of bone and cartilage O Deformities ("Moderate" and "severe" scoliosis are excluded) O Spondylolisthesis (Grades 3 and 4 are excluded – per radiology report or physician note.)

If spondylolisthesis is indicated as “grade 2 to 3” the preference of MSSIC is that the surgeon make a call on whether it is grade 2 or 3. However, if it is not possible to obtain a definitive answer from the surgeon, the “grade 2 to 3” case should be excluded as “grade 3.” MSSIC would rather inadvertently exclude an occasional grade 2 case than allow introduction of grade 3 cases into the registry.

O Congenital anomalies of the nervous system (spinal cord-related) O Traumatic fracture O Spinal cord injury MSSIC is looking for those codes indicated by surgeon on consult notes or clinic visits where surgery is determined.

Other (for use only with approval of MSSIC Coordinating Center)

O Other ArborMetrix is continually updating the code list that is hard-wired in the registry. If a code is listed in the in Appendix A of the ManOp (the most updated list is online) it can be assumed that it is an “approved code” and may be added here, and it will eventually be hard-wired. Otherwise, contact the Coordinating Center for approval to use “Other.”

If “Other” ICD-10 Code Exclusion Criteria

Specify Other

As above indicated, Contact Coordinating Center approval to use “Other.”

Completed review of Exclusion Criteria?

O Review complete – NOT EXCLUDED (Please proceed to inclusion criteria) O Review complete – EXCLUDED (No further data entry is necessary at this time)

If patient has met exclusion criteria - data entry stops here.

If patient has met exclusion criteria - data entry stops here.



Tab Name: INCLUSION (Highlighted variables are lumbar only)

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ICD Diagnosis Codes Diagnosis Codes Available:

O ICD-10 diagnosis codes Choose the format of the codes being entered.

Enter appropriate diagnosis codes

See Codes as listed in the Manual of Operations Appendix B, and in the FAQ document.

Check all codes that apply which represent the reason for exclusion. Please remember to review the medical record for all inclusion criteria. For example, do not rely on a primary code added to a surgery schedule by a scheduler. The Codes as listed cover primarily the following categories: O Spondylosis and allied disorders O Intervertebral disc disorders (Intervertebral disc: Lies between adjacent vertebrae in the vertebral column. Provides a cushion between each of the vertebral bodies and binds them together.) O Other disorders of cervical region O Other and unspecified disorders of back O Other acquired musculoskeletal deformity. (Grades 1 and 2 are included – per radiology report or physician note.) O Other congenital musculoskeletal anomalies. (Grades 1 and 2 are included – per radiology report or physician note.) O Complications peculiar to certain specified procedures MSSIC is looking for those codes indicated by surgeon on consult notes or clinic visits where surgery is determined.

Other (for use only with approval of MSSIC Coordinating Center)

O Other ArborMetrix is continually updating the code list that is hard-wired in the registry. If a code is listed in the in Appendix B of the ManOp (the most updated list is online) it can be assumed that it is an “approved code” and may be added here, and it will eventually be hard-wired. Otherwise, contact the Coordinating Center for approval to use “Other.”

If “Other” ICD-10 Code Inclusion Criteria

Specify Other

As above indicated, Contact Coordinating Center approval to use “Other.”

Completed review of Inclusion Criteria?

O Review complete - INCLUDED (proceed with data entry) O Marked for review


Appendix L - Master Variable List – Lumbar Module Tab Name: Inclusion

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If inclusion criteria are met, data entry continues:

Location of Spine Surgery

O Lumbar O Cervical O Both

For MSSIC purposes: "Lumbar" location involves one or more of vertebrae L1 to L5 with possible extension down to S1 or up to T10. Sacroiliac joint fusion/fixations are outside of the scope of MSSIC; however fixation of 1 or more of the lumbar vertebrae to the pelvis or ilium is within the scope of MSSIC. "Cervical" location involves one or more of the vertebrae of the neck extending from C2 to C7, but may include extension down to T3.

Pathologies to be addressed by surgery (Lumbar) Check all that apply.

O Symptomatic lumbar disc herniation O Lumbar spondylolisthesis O Lumbar stenosis O Symptomatic recurrent lumbar disc herniation O Lumbar adjacent segment disease O Revision of hardware O Other

Symptomatic lumbar disc herniation: Degenerative lumbar disc herniation that results in nerve root compression causing pain, weakness, or numbness in the distribution of the affected nerve root. Presence of disc herniation may be identified by MRI or CT. Note: Surgeons do not always use the phrase “nerve root” to document this condition.

For MSSIC purposes select disc herniation for either protrusion or disc bulge.

Lumbar spondylolisthesis: Grade I and II lumbar spondylolisthesis occurring from a congenital deformity of the pars interarticularis or from a degenerative process associated with spinal canal, and/or foraminal stenosis that results in mechanical back pain and/or radiating leg pain, or neurogenic claudication in the distribution of the affected nerve roots. Lumbar spondylolisthesis can be identified by either MRI or CT with an anterior or posterior slip of an adjacent vertebral body by no more than 50%. Patients with a slip of greater than 50%, (Grades III and IV spondylolisthesis) are not included.

More clarification regarding listhesis: Listhesis means the vertebrae are not properly aligned (misalignment). DO NOT interpret “listhesis” as instability. Listhesis is also mentioned as the following terms: spondylolisthesis, anterolisthesis, retrolisthesis, hypermobility.

Lumbar stenosis: Degenerative narrowing of the central, lateral recess, or foraminal lumbar spinal canal without listhesis or dynamic instability that results in nerve root compression causing pain, weakness, numbness, or neurogenic claudication in the distribution of the affected nerve roots. Lumbar stenosis may be identified by MRI or CT. Note: Surgeons do not always use the phrase “nerve root” to document this condition.

We are capturing lumbar stenosis WITHOUT instability here. Lumbar stenosis WITH instability is captured under the Lumbar spondylolisthesis answer option. However, do not let this lead you to believe that only one answer can be



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chosen (lumbar stenosis vs. lumbar spondylolisthesis). Choosing both is possible at times.

The terms central stenosis and canal stenosis are synonymous.

Symptomatic recurrent lumbar disc herniation: Degenerative lumbar disc herniation at the same level and side of a prior surgical discectomy (non-fusion) that results in nerve root compression that causes pain, weakness, or numbness in the distribution of the affected nerve root. Presence of disc herniation may be identified by MRI or CT. Note: Surgeons do not always use the phrase “nerve root” to document this condition.

For MSSIC purposes: choose disc herniation for either disc protrusion or disc bulge.

Lumbar adjacent segment disease: While true/technical cases of “adjacent segment disease” are complicated to diagnose, MSSIC is simply looking for cases where surgery is required to a disk adjacent to a disk previously operated on fused.

Revision of Hardware: Surgery involving complication or failure of previously placed hardware. This would include planned removal of hardware. Procedure Codes captured later in this data entry process will allow for proper analysis of what actually takes place.

Other: Enter pseudoarthrosis following fusion cases here if they are not found to fall into any of the remaining categories.

If "Other”:

Specify Other



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Clinical presentation for surgery (Lumbar)

Check all that apply.

O Axial pain (back/neck pain) O Radicular pain (pain radiating to an extremity) O Muscle weakness O Footdrop O Bowel or bladder dysfunction O Other

It is reasonable for abstractors to use their discretion when “axial” and “radial” are not literally mentioned in the surgeon’s dictation by using the following definitions.

Note: It is possible that the patient has both axial and radicular pain.

Axial pain: Axial pain, also called mechanical pain, is the most common cause of back or neck pain and may present in a number of different ways (sharp or dull, constant or comes and goes, etc). It is confined to the back or neck (or in the posterior paramedian neck muscles, with radiation to the occiput, shoulder, or parascapular region) and does not travel into an arm or leg.

If axial pain is chosen as a clinical presentation, be sure to answer “Yes” on the History Tab to “Axial pain”.

Radicular symptoms or radiculitis: Numbness, tingling, pain, or weakness "radiated" along the dermatome (sensory distribution) of a nerve due to compression, inflammation or other irritation of the nerve root (radiculopathy) at its connection to the spinal column. Weakness: For MSSIC purposes, weakness reported by patient only but not documented (either by report or exam) by the surgeon or staff is not currently being collected in this registry.

For pre-surgical documentation MSSIC is most interested in weakness BELOW the area of involvement. For example, on Lumbar modules indicate “Yes” if the weakness involves the legs, otherwise “No”. On the Cervical module indicate “Yes” if the weakness involves the arms and/or legs. Later for post-surgical “weakness” should be deemed to include any motor weakness regardless of location.

Dermatome: A Dermatome is the area of sensory nerves near the skin that are supplied by a specific spinal nerve root. The body can be divided into regions that are mainly supplied by a single spinal nerve. There are eight cervical (one for the head, and one for each cervical vertebra), twelve thoracic, five lumbar and five sacral spinal nerves. Dermatomes are useful for finding the site of damage to the spine. For example, leg pain from radiculopathy often indicates a problem to a specific nerve root in the lumbar spine. A Dermatome diagram is available as Appendix L (Pictures and Diagrams of Spine Anatomy) in the MSSIC Manual of Operations.

Footdrop: An extended position of the foot caused by paralysis of the flexor muscles of the leg.

Bowel or bladder dysfunction: Problems storing or removing stool from the intestines or urine from the bladder due to nerve damage. Here MSSIC is looking for documented “Neurogenic” bowel or bladder dysfunction.

If neurogenic bowel or bladder dysfunction is chosen as a clinical presentation, be sure to answer “Yes” on the History Tab to “Neurogenic Bowel or Bladder Dysfunction”.



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If "Other”:

Specify Other

Is this case a returning patient previously added in this registry?

O Yes O No

If “Yes” please note the procedure regarding “-1” Patient Registry ID#.

If “Is this case a returning patient previously added in this registry?” is “Yes”:

Has it been more than 2 years since last surgery?

O Yes O No

Specifically, has the final patient-provided questionnaire been completed at approximately the 2 year point? Or, if not completed, has the time frame for completing the 2 year questionnaire lapsed?

If “Is this case a returning patient…” is “Yes” AND “Has it been more than 2 years…” is “No”:

What was the location of the previous surgery?

O Cervical O Lumbar O Both

Scoliosis* O Yes O No O Not documented

Scoliosis is abnormal curvature of the spine in the coronal (lateral) plane

If “Scoliosis” is “Yes”:

Is the scoliosis described as:

O Mild (< 25 degrees) O Not described

Scoliosis less than 25 degrees is considered mild. Less than 10° is postural variation.



Tab Name: HISTORY (Highlighted variables are lumbar only)

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Ambulation is: O Independent O With an assistive device O Wheelchair bound (non-ambulatory) O Not documented

If conflicts are found in the record be mindful to use recent records. If conflicts are still apparent in recent records, record the least severe as patient’s peak ambulation. If mention is made in the record that “gait is steady,” or “gait is without abnormality,” or “gait is normal” then “independent” may be assumed.

Primary Insurance O BCBSM Michigan O Medicare Advantage - BCBSM O Other Payer - Michigan and Outstate O BCN Michigan O Medicare Advantage BCN O Medicaid - HMO O Commercial - HMO O Medicare (all) O Medicaid Straight O Private O Other Payer (government) O No Insurance/Self-Pay

The carrier responsible for providing benefits before any other insurer makes payment. Type of coverage should be based on: 1. Primary carrier 2. At the time the case is entered into the registry 3. County of coverage See Appendix C of the Manual of Operations for further details about these insurer categories.

Diabetes O No O Yes, Type I O Yes, Type II - Insulin dependent O Yes, Type II - Non-insulin dependent

As documented by PCP or anywhere in the medical history. NOTE: If yes to diabetes but there is no documentation of type or treatment choose “Yes, Type II – non-insulin dependent.” If yes to diabetes, insulin dependent but there is no documentation of type choose “Yes, Type II – insulin dependent.”

Coronary Artery Disease (CAD)

O Yes O No

As documented by PCP or anywhere in the medical history.

Known Osteoporosis or Osteopenia

O Yes O No

As documented by PCP or anywhere in the medical history. This does not need to be documented by any specific test. Choose “yes” for documentation that the patient has “low bone mass”.

Anxiety Disorder O Yes O No

As documented by PCP or anywhere in the medical history. Post-Traumatic Stress Disorder (PTSD) does not constitute anxiety disorder.


Appendix F - Master Variable List – Lumbar Module Tab Name: History

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Depression Disorder O Yes O No


Did the patient ever have a blood clot (deep venous thrombosis)?

O Yes O No


Does the record show that the patient has a tendency to form blood clots?

O Yes O No

As documented by PCP or anywhere in the medical history: “hypercoagulable state”; history of DVT/PE; documented lab test showing clotting disorder, or presence of Factor V Leiden. Do not rely solely on IVC filter placement, or anticoagulant use after stent, or medication prescribed to prevent blood clots due to atrial fibrillation.

Any previous surgery O Yes O No O Not documented

Does the patient have any previous history of any type of surgery?

If "Yes" Spine surgery?

O Yes O No O Not documented

If "Yes" Which spine surgeries?

O Cervical O Lumbar O Thoracic O Thoracolumbar O Other O Not documented

If the surgery was a spine surgery, indicate location here.

If "other" Specify other:

Enter the type of "Other" Spine Surgery that was performed.

If “Yes” to “Spine Surgery?”

Did the patient ever have a fusion?


If “Yes” to “Did the patient ever have a fusion?”

Was instrumentation used?


If "Yes" on Spine Surgery?

When was the most recent spine surgery?

O Less than or equal to 90 days O Over 90 days but less than or equal to 1 year O Over 1 year but less than or equal to 2 years O Over 2 years ago O Not documented



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If "Yes" on Spine Surgery?

Was this most recent spine surgery a fusion?


This question refers to the above mentioned “most recent spine surgery”. Previously the third answer option read “Not indicated” as in it was not indicated whether the surgery was a fusion. That has been corrected to “Not documented as of May 2016.”

If "Yes" on "Fusion"

Was instrumentation used?


This question refers to the above mentioned “most recent spine surgery”. Previously the third answer option read “Not indicated” as in it was not indicated whether the surgery was a fusion. That has been corrected to “Not documented as of May 2016.”

If "Yes" on previous surgery

Non-spine surgery? Check all that apply.

O Cardiac O Joint replacement (upper extremity/shoulder) O Joint replacement (lower extremity/knee or ankle) O Peripheral nerve surgery (carpal tunnel/ulnar nerve)

Indicate if patient has undergone any of these specific procedures.

Patient Symptoms (Check at least one):

O Numbness/tingling O Pain O Weakness O Not documented

Weakness: For MSSIC purposes, weakness reported by patient only, but not documented (either by report or exam) by the surgeon or staff, is not currently being collected in this registry. For pre-surgical documentation MSSIC is most interested in weakness BELOW the area of involvement. For example, on Lumbar modules indicate “Yes” if the weakness involves the legs, otherwise “No”. On the Cervical module indicate “Yes” if the weakness involves the arms and/or legs. Later for post-surgical “weakness” should be deemed to include any motor weakness regardless of location.



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What was the predominant location of pain? (Check one)

O Back dominant O Leg dominant O Back and leg are equal O No pain O Not documented

If there is a question about which is dominant, back or leg, the degree of pain may be indicated in physical examination notes (…on a scale of 1 to 10,…) This question refers to the predominant location of pain during the time period when the patient is seeing the surgeon in consultation for surgery. Use chart abstraction, not patient questionnaires, to answer variable. If no reference is made to one being dominant, either back or leg, then “equal” may be assumed. For MSSIC purposes for this question only: Buttock = Leg and Hip = Leg.

Axial pain (back/neck pain)


It is reasonable for abstractors to use their discretion when “axial” and “radial” are not literally mentioned in the surgeon’s dictation by using the following definitions. Additionally, it is possible that the patient has both axial and radicular pain:


Mechanical pain is axial pain but axial pain is not always mechanical.

Myelopathy


A set of symptoms and signs consistent with spinal cord dysfunction. This is best left to the surgeons to diagnose/document. However, as noted below, for MSSIC purposes Abstractors should consider the presence of myelopathy indicated when myelomalacia is mentioned in the record. Do not rely on coding references to “with myelopathy” if the surgeon does not otherwise make reference to myelopathy.

NOTE: For MSSIC purposes Abstractors should consider the presence of myelopathy indicated when myelomalacia is mentioned in the record.



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Neurogenic bowel or bladder dysfunction


The difficulty occurring when the body has problems storing and removing stool from the intestines or urine from the bladder due to nerve damage. Surgeons should document “neurogenic” bowel or bladder dysfunction”.

Neurogenic claudication O Yes O No O Not documented

A common symptom of spinal stenosis or inflammation of the nerves emanating from the spinal cord. Neurogenic refers to the problem having its origin at a nerve, and claudication is from the Latin term for limp, because the patient feels a painful cramping or weakness in the legs. Roman emperor Claudius (ruled from AD 41-54) was so named because he limped, probably because of a birth defect. If “shopping cart syndrome” is seen, the abstractor may dig deeper into the record or check with the surgeon, but do not document “yes” on neurogenic claudication based on the notation of shopping cart syndrome alone. Surgeons should document neurogenic claudication.

Does the patient have any motor deficits?

O Yes O No O Abnormal with possible contributing factor O Not documented

A lack or impairment of muscle function. On examination anything less than 5/5 is a deficit - choose "Yes." Note: For more info on motor examination see glossary. If contributing factors are mentioned, such as: O poor effort O antalgia O breakaway O mental status issues Choose "Abnormal with possible contributing factor"

Duration of longest standing spine symptoms

Cons O Less than 3 months O Greater than 3 months but less than 1 year O 1 year or more O Not documented

According to consult note. Longest standing refers to continuous symptoms. If there was a gap in symptom time frame use the most recent continuous time frame.



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Non-surgical/non-pharmacologic treatment for current condition (within the last year) Check all that apply.

O Physical therapy O Chiropractor O Injection O Other (nonsurgical treatment for current condition) O None O Not documented

Physical therapy: a branch of rehabilitative health that uses specially designed exercises and equipment to help patients regain or improve their physical abilities. Chiropractor: a chiropractic practitioner, one who treats patients by spinal adjustment or manipulation. Injection: spinal injections for treatment of pain. May include epidural steroid injections as well as nerve blocks. Other: Do not include medications in this category. Other non-surgical treatment can include: O Activity Modification O Conservative Management O Brace O Conservative Management O Massage Therapy O Traction O Yoga O Acupuncture DO NOT INCLUDE IN OTHER: O Aromatherapy/Incense O Ice/Heat If there is no indication of time frame of treatment but symptoms have only existed for 1 year, it may be assumed that the treatment was also within the last year, otherwise use “Not documented”.

Was there listhesis or dynamic instability (level of surgery only)

O Yes O No O Not documented O Record not available

Listhesis: Abnormal displacement or slipping of a vertebra over a lower segment. Include anterolisthesis, retrolisthesis, and spondylolisthesis here as well. Note: Instability is not always indicative of listhesis. Instability as reported by surgeon is the only acceptable documentation for instability. Abstractors do not need to find documented radiographic evidence in the record.

No further information available in the record. Chart abstraction is complete.

O Yes O No


Appendix L Master Variable List - Lumbar Module

Tab Name: Baseline Contact

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Abstractor Method of Contact for Patient Baseline Questionnaire

O E-mail O Phone O U.S. Mail O In office

Choosing "E-mail" and entering an e-mail address will prompt an e-mail to the patient instructing them on using the MSSIC web-site patient portal.

If "E-mail"

E-mail address

Enter the e-mail address where the patient has elected to receive an e-mailed link to the patient portal for completion of the baseline questionnaire. Be very careful to enter the e-mail address correctly.


Appendix L - Master Variable List – Lumbar Module Tab Name: Baseline Contact




Tab Name: Baseline Questionnaire (Highlighted variables are lumbar only)


Date of Questionnaire Date auto-populates for patients using web portal.

Person entering "patient-provided" data in registry

O Abstractor O Patient - through web-portal

Please describe your back and leg pain when off your pain medication. Please rate your back pain and leg pain on a scale of 0 to 10, where zero (0) would mean "no pain" and a ten (10) would mean "worst pain imaginable." For example, describe your pain when you are off your medication, after your pain medication has worn off, when you are due to take your next pill, that is please describe how your pain would feel if you were not on pain medication.

Note: If the patient states that they do not have pain so the question does not apply and they don’t know how to answer they are free to skip the question and other questions that refer to pain.

Please rate your back pain on a scale of 0 to 10 over the past 7 days.

0 through 10 Note: If the patient states that they do not have pain so the question does not apply and they don’t know how to answer they are free to skip the question and other questions that refer to pain.

Now, please rate your leg pain on a scale of 0 to 10 over the past 7 days.


This questionnaire is designed to give us information as to how your back (or leg) trouble affects your ability to manage in everyday life. Please answer every section. Mark one box only in each section that most closely describes you today.

Section 1 - Pain intensity O I have no pain at the moment O The pain is very mild at the moment O The pain is moderate at the moment O The pain is fairly severe at the moment O The pain is very severe at the moment O The pain is the worst imaginable at the moment


Appendix L - Master Variable List – Lumbar Module Tab Name: Baseline Questionnaire


Section 2 - Personal care (washing, dressing, etc.)

O I can look after myself normally without causing extra pain O I can look after myself normally but it is very painful O It is painful to look after myself and I am slow and careful O I need some help but manage most of my personal care O I need help every day in most aspects of self care O I do not get dressed, wash with difficulty and stay in bed

Section 3 - Lifting O I can lift heavy weights without extra pain O I can lift heavy weights but it gives extra pain O Pain prevents me from lifting heavy weights off the floor but I can manage if they are conveniently positioned, e.g. on a table O Pain prevents me from lifting heavy weights but I can manage light to medium weights if they are conveniently positioned O I can lift only very light weights O I cannot lift or carry anything at all

Section 4 - Walking O Pain does not prevent me walking any distance O Pain prevents me walking more than one mile O Pain prevents me walking more than a quarter of a mile O Pain prevents me walking more than 100 yards O I can only walk using a stick or crutches O I am in bed most of the time and have to crawl to the toilet

Section 5 - Sitting O I can sit in any chair as long as I like O I can sit in my favorite chair as long as I like O Pain prevents me from sitting for more than 1 hour O Pain prevents me from sitting for more than half an hour O Pain prevents me from sitting for more than 10 minutes O Pain prevents me from sitting at all




Section 6 - Standing O I can stand as long as I want without extra pain O I can stand as long as I want but it gives me extra pain O Pain prevents me from standing for more than 1 hour O Pain prevents me from standing for more than half an hour O Pain prevents me from standing for more than 10 minutes O Pain prevents me from standing at all

Section 7 - Sleeping O My sleep is never disturbed by pain O My sleep is occasionally disturbed by pain O Because of pain I have less than 6 hours sleep O Because of pain I have less than 4 hours sleep O Because of pain I have less than 2 hours sleep O Pain prevents me from sleeping at all

Section 8 - Sex life (if applicable) O My sex life is normal and causes no extra pain O My sex life is normal but causes some extra pain O My sex life is nearly normal but it is very painful O My sex life is severely restricted by pain O My sex life is nearly absent because of pain O Pain prevents any sex life at all

Note: Leave blank if not active or decline. The Oswestry will score with some questions left blank.

Section 9 - Social life O My social life is normal and causes me no extra pain O My social life is normal but increases the degree of pain O Pain has no significant effect on my social life apart from limiting my more energetic interests, e.g. sports, etc. O Pain has restricted my social life and I do not go out as often O Pain has restricted social life to my home O I have no social life because of pain




Section 10 - Traveling O I can travel anywhere without pain O I can travel anywhere but it gives extra pain O Pain is bad but I manage journeys over two hours O Pain restricts me to journeys of less than one hour O Pain restricts me to short necessary journeys under 30 minutes O Pain prevents me from traveling except to receive treatment

Total ODI Sum Score (auto calculated)

Quality of Life (EQ-5D)

By marking the one box in each group below, please indicate which statements best describe your own health state today.

Mobility O I have no problems in walking about O I have some problems in walking about O I am confined to bed

Self-Care O I have no problems with self-care O I have some problems washing or dressing myself O I am unable to wash or dress myself

Usual Activities (e.g. work, study, housework, family or leisure activities)

O I have no problems with performing my usual activities O I have some problems with performing my usual activities O I am unable to perform my usual activities

Pain/Discomfort O I have no pain or discomfort O I have moderate pain or discomfort O I have extreme pain or discomfort

Anxiety/Depression O I am not anxious or depressed O I am moderately anxious or depressed O I am extremely anxious or depressed

EQ-5D Score (auto calculated)




To help people say how good or bad a health state is, we have drawn a scale (rather like a thermometer) on which the best state you can imagine is marked 100 and the worst state you can imagine is marked 0. We would like you to indicate on this scale how good or bad your own health is today, in your opinion. Please do this by choosing a number on the scale to indicate how your health is TODAY. Now, please enter the number you chose on the scale in the box provided.

0 through 100

Do you participate in activities outside the home (i.e. gardening, golf, walking, cycling, volunteering)?

O Yes O No

If "Do you participate in activities outside the home?" is "Yes":

Would you describe your activity as…

O Sedentary or Light O Moderate O Strenuous

Do you participate in activities inside the home (vacuuming, cooking, general housework)?

O Yes O No

If ""Do you participate in activities inside the home?" is "Yes":

Would you describe your activity as…

O Sedentary or Light O Moderate O Strenuous

Do you plan on returning to your previous activity?

O Yes O No

On a daily basis, do you generally walk… O Independently O With an assistive device (cane or walker) O Do not walk (wheelchair bound)

Over the last 2 weeks, how often have you been bothered by any of the following problems?

1. Little interest or pleasure in doing things

O Not at all O Several days O More than half the days O Nearly every day

2. Feeling down, depressed, or hopeless O Not at all O Several days O More than half the days O Nearly every day




Smoking O Current every day smoker O Current some days smoker O Former smoker O Never smoked O Prefer not to answer

Per CDC, all definitions are based on 100 cigarettes. Tobacco only. • Current every day smoker: An adult who has smoked at least 100 cigarettes in his or her lifetime, and who now smokes every day. • Current some days smoker: An adult who has smoked at least 100 cigarettes in his or her lifetime, who smokes now, but does not smoke every day. • Former smoker: An adult who has smoked at least 100 cigarettes in his or her lifetime but who had quit smoking at the time of interview. • Never smoked: An adult who has never smoked, or who has smoked less than 100 cigarettes in his or her lifetime. • Prefer not to answer

Do you take opioid painkillers daily to control your pain? (prescription medications such as Vicodin, Lortab, Norco, hydrocodone, codeine, Tylenol #3 or #4, fentanyl, Duragesic, MS Contin, Percocet, Tylox, OxyContin, oxycodone, methadone, tramadol, Ultram, Dilaudid)

O Yes O No

If “Yes” to “…painkillers…”: How long have you been using opioid painkillers on a daily basis?

O Less than 3 weeks O 3 weeks but less than 6 weeks O 6 weeks but less than 3 months O 3 months but less than 6 months O 6 months or greater

Was your spinal injury caused by a motor vehicle injury?

O Yes O No O Unknown

Workers Compensation Claim O Yes O No O Undecided O Prefer not to answer

Liability or Disability Insurance Claim O Yes O No O Undecided O Prefer not to answer




Are you working? O Yes Full-time O Yes Part-time O No O Retired O Volunteering O On disability

If ""Are you working " is "Yes Part-time"

Is the part-time status because of your neck or back problems?

O Yes O No

If "Are you working?" is "Yes" Either "Full-time" or "Part-time":

Would you say your job was…

O Sedentary O Light O Medium O Heavy


Does your job require you to stand up to 6 hours per day?

O Yes O No


Does your job require you to lift …

O Frequently more than 50 pounds O Frequently more than 25 pounds and occasionally 50 pounds O Frequently 10 pounds and occasionally 25 pounds O Occasionally up to 10 pounds

Regardless of your current work status, do you plan to return to work after your surgery?

O Yes O No O Unknown

If "Are you working?" is "Retired":

Are you retired because of your back or neck problems?

O Yes O No

If "Are you working?" is "No":

Are you not working because of your back or neck problems?

O Yes O No

Race/Ethnicity O White O Black or African American O Asian O Hispanic or Latino O American Indian O Unknown/Refused O Other




Level of Education O Less than High School O High School Diploma or GED O Two-Year College Degree O Four-Year College Degree O Post-College

What is your preference for future contact for this study?

O E-mails with access to web-based questionnaires O Telephone calls with questionnaires interview process O Mailings with paper questionnaires to be returned

NOTE: This question (as well as the branching email address question below) does not appear on the Postop Questionnaire Tab, but is provided on case report forms for distribution to patients. If a change is made it needs to be made on the Baseline Questionnaire Tab.

If "What is your preference for future contact for this study?" is "E-mails ….":

Email Address

Here enter the e-mail address which will be used to contact the patient for the purposes of instructing them on use of the MSSIC Patient Portal for completing patient questionnaires.

Tab/Questionnaire/Task is complete:

O Complete (to the extent the patient was willing to answer) O Incomplete (last surgery was too recent) O Incomplete (surgery was an add on with 2 days or less notice to abstractor) O Incomplete (patient refused) O Incomplete - Patient did not follow through (paper version not returned/didn’t log in to web portal) O Incomplete (unable to contact patient/questionnaire window closed) O Incomplete (patient does not speak English/language barrier)

Use "Unable to contact patient" if attempts have been made in accordance with MSSIC guidelines (3 contact attempts at different times). Patient does not speak English/Language barrier: Please use this for additional barriers to patient completion as well – for example the mentally disabled patient, etc.



Tab Name: Confirmation

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Was surgery performed? O Yes O No – Cancelled (NOTE: If cancelled change “Status” of this record to “Surgery Cancelled”) O Rescheduled

Actual Date of Surgery


Appendix F - Master Variable List - Lumbar Module Tab Name: Confirmation




Tab Name: Procedure (Highlighted variables are lumbar only)

NOTE: MSSIC policy has been to capture all procedural information for 2-staged spine surgeries that are within the scope of MSSIC and are performed on a given stay within one record in the registry. As of May 20, 2016 please use this process for procedural information for unplanned returns to OR that occur on that stay as well. If the separate procedures result in conflicts in answers for a given variable, for example ASA or antibiotic use, use the answer appropriate to the last procedure.

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Date of Surgical Procedure Chart Abstraction

Was this an inpatient or outpatient procedure?

O Inpatient O Outpatient

As indicated by the manner in which this procedure was ultimately billed by your facility. For example, if the procedure was initially planned as an outpatient procedure but the patient ultimately was admitted and the procedure billed as an “inpatient” procedure, then choose “inpatient”. If it was still ultimately billed as an “outpatient” then choose “outpatient.”

Measurement System O Imperial O Metric

Please indicate which system is being used to document height and weight so that the appropriate calculation may be applied for BMI.

If measurement system is “Imperial”:

Anes Flw Ch SurgBd

Height (in) Anes Flw Ch SurgBd

If height is recorded in inches, enter the number here.

Weight (lb) If weight is recorded as pounds, enter the number here.

If measurement system is “Metric”:

Height (cm) Anes Flw Ch SurgBd

If height is recorded in centimeters, enter the number here.

Weight (kg) Anes Flw Ch SurgBd

If weight is recorded as kilograms, enter the number here.

BMI (auto calculated) Body mass index will be auto-calculated here based on the patient's height and weight. An adult who has a BMI of 30 or higher is considered obese.

Gender O Male O Female O Unknown

Procedure Codes available:

O CPT Procedure Codes O ICD-10 Procedure Codes

CPT Procedure Codes are the preference. Abstractors should check with Coordinating Center for approval to use ICD-10 Procedure Codes. *CPT refer to physician billing of procedure *ICD-10 refer to hospital billing of procedure


Appendix L - Master Variable List – Lumbar Module Tab Name: Procedure

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If "Procedure Codes available" is "CPT":

CPT Procedure Code Enter all that apply

Enter all CPT Procedure Codes which apply to this case. Some are hard-wired and can be marked as applicable, any additional codes can be entered into the box available in the next question. The list of expected CPT Procedure Codes appears as Appendix D in the Manual of Operations.

Additional CPT Procedure Codes not otherwise listed

SurgBd Op Nt

Enter any and all CPT Procedure Codes which are applicable, but not listed and checked above.

If "Procedure Codes available" is "ICD-10":

ICD-10 Procedure Code Enter all that apply

SurgBd Op Nt

Enter all ICD-10 Procedure Codes which apply to this case. Hard-wired and can be marked as applicable, any additional codes can be entered into the box available in the next question. The list of expected ICD-10 Procedure Codes appears as Appendix E in the Manual of Operations.

Additional ICD-10 Procedure Codes not otherwise listed

SurgBd Op Nt

Enter any and all ICD-10 Procedure Codes which are applicable, but not listed and checked above.

ASA Grade (per anesthesia operative report)

Anes O 1 O 2 O 3 O 4 O 5 O Record not available

American Society of Anesthesiologists' (ASA) system for assessing the fitness of patients before surgery, comprised of numbers 1 through 5, 1 representing a healthy individual and 5 representing someone not expected to survive 24 hours (with or without surgery).

Estimated Blood Loss Documented as…

Anes O Minimal O Not documented O Documented cc's

Enter notation in the surgical report as to the estimated blood loss. Note: May be recorded as ml ml = cc Note: If a discrepancy exists regarding EBL (estimated blood loss) volume then the following applies:

Anesthesia trumps all or

Nursing trumps surgeon record



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If "Estimated Blood Loss Documented as…" is "Documented cc's":

Estimated Blood Loss (cc)

Anes

If the notation gives the estimated blood loss in cc's please enter the number here. Note: May be recorded as ml ml = cc Note: When values have the symbols of < or > in front of the numeric value, enter the numeric value immediately below for “less than” and immediately above for “greater than” without the symbol. For example “<25 cc” would be entered as “24”. Note: Do not reduce the amount of estimated blood loss by the amount of blood re-infused using a cell-saver, or other means.

Surgery Start Time (please use military time)

Anes Time of first incision. Please use military time. If no start or stop time is available enter 00:00. If only a start or a stop is available enter it into both fields. Length of surgery will then error out as 0.

Surgery Stop Time (please use military time)

Anes Time of last closure. Please use military time. If no start or stop time is available enter 00:00. If only a start or a stop is available enter it into both fields. Length of surgery will then error out as 0.

Length of Surgery (minutes) (auto calculated)

This field will be automatically calculated based on the date and time of the start of the surgery and the completion of the surgery.

Second Surgery Anes O Yes O No

Second Surgery on same hospitalization scheduled as a 2-stage surgery where the two separate stages were documented as separate procedures with their own start and stop times and/or estimated blood loss.

If "Second Surgery" is "Yes"

Date of Second Surgery

Second Surgery on same hospitalization scheduled as a 2-stage surgery where the two separate stages were documented as separate procedures with their own start and stop times and estimated blood loss.



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If "Second Surgery" is "Yes"

Second Surgery Estimated Blood Loss Documented as…

Anes O Minimal O Not documented O Documented cc's

Enter notation in the surgical report as to the estimated blood loss. Note: May be recorded as ml ml = cc Note: If a discrepancy exists regarding EBL (estimated blood loss) volume then the following applies:

Anesthesia trumps all or

Nursing trumps surgeon record

If "Second Surgery Estimated Blood Loss Documented as…" is "Documented cc's":

Second Surgery Estimated Blood Loss (cc)

Anes

If the notation gives the estimated blood loss in cc's please enter the number here. Note: May be recorded as ml ml = cc

Second Surgery Start Time (please use military time)

Anes Time of first incision. Please use military time. If no start or stop time is available enter 00:00. If only a start or a stop is available enter it into both fields. Length of surgery will then error out as 0.

Second Surgery Stop Time (please use military time)

Anes Time of last closure. Please use military time. If no start or stop time is available enter 00:00. If only a start or a stop is available enter it into both fields. Length of surgery will then error out as 0.

Length of Second Surgery (minutes) (auto calculated)

This field will be automatically calculated based on the date and time of the start and completion of the second surgery in a two-stage procedure.

Levels Surgically Altered (Lumbar)

O T10 O T11 O T12 O L1 O L2 O L3 O L4 O L5 O S1 O Ilium O Pelvis

According to Surgeon’s Operative Note only. Do not count “bone marrow harvest” sites in levels surgically altered. Ilium involvement would be, for example, in circumstances such as placement of iliac screw/bolt. Pelvis involvement would be, for example, in circumstances such as placement of sacral alar screw.



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Surgical approach Check all that apply.

Op Nt O Anterior O Posterior O Lateral O Others O Not documented

Anterior: When the spine is approached from the front, rather than the back. Posterior: When the spine is approached from the back. Lateral: When the spine is approached from the side. NOTE: Posterolateral should be recorded as Posterior and NOT as Posterior and as Lateral.

Was a laminectomy / laminotomy / foraminotomy performed?

Op Nt O Yes O No

As these are all decompression procedures, answer “Yes” if any of them were performed. These include “hemi” laminectomies etc., as well.

Laminectomy: A surgical procedure that completely removes the posterior arch of the vertebrae called the lamina. The removal of the back of one or more vertebrae, usually to give access to the spinal cord or to relieve pressure on nerves. Bone spurs and ligaments that are pressing on nerves may be removed at the same time. Laminectomy is one of the most common back surgeries. For laminectomy count vertebral levels. Hemilaminectomy: This is a “partial laminectomy” which technically would be a “laminotomy”. Therefore, hemilaminectomy would be treated the same as laminotomy for counting purposes. For hemilaminectomy count spaces between vertebrae.

Laminotomy: Partial removal of the lamina (the part of the neural arch of a vertebra extending from the pedicle to the median line). For laminotomy count spaces between vertebrae. Foraminotomy: A medical operation used to relieve pressure on nerves that are being compressed by the intervertebral foramina (the passages through the bones of the vertebrae of the spine that pass nerve bundles to the body from the spinal cord). For foraminotomy count spaces between vertebrae.



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If "Was a laminectomy / laminotomy / foraminotomy performed?" is "Yes":

Number of laminectomy / laminotomy / foraminotomy levels performed?

Op Nt O 1 O 2 O 3 O 4 O more than 4

1. Count foraminotomies, laminotomies, and hemilaminectomies first, get a total count.

• For foraminotomy count spaces between vertebrae. • For laminotomy count spaces between vertebrae. • For hemilaminectomy count spaces between vertebrae.

2. If laminectomies are done on the same vertebrae involved with the counts for the above procedures, then do not add any additional levels for these laminectomies into the count. 3. If laminectomy is done for vertebrae not already involved in the foraminotomy/laminotomy/ hemilaminectomy count, then count those based on the instructions below and add that number to the total count. • For laminectomy count vertebral levels.

Was arthrodesis performed?

Op Nt O Yes O No

The surgical immobilization of a joint so that the bones grow solidly together, also known as fusion. Arthrodesis is also known as artificial ankylosis or syndesis, is the artificial induction of joint ossification between two bones via surgery. This is done to relieve intractable pain in a joint which cannot be managed by pain medication, splints, or other normally-indicated treatments.



If "Was arthrodesis performed?" is "Yes"

Which types of interbody arthrodesis? Check all that apply

Op Nt Interbody: O ALIF (Lumbar) O PLIF (Lumbar) O TLIF (Lumbar) O DLIF/XLIF (Lumbar) O ACDF (Cervical) O ACCF/Fusion by Corpectomy (Cervical) O Others O None

Arthrodesis: The surgical immobilization of a joint so that the bones grow solidly together, also known as fusion.

NOTE: The “I” in the acronyms stands for "Interbody".

Interbody: Performed between the bodies of two contiguous vertebrae. NOTE: if documentation says interbody then also choose yes to the discectomy variable.

ALIF: Anterior Lumbar Interbody Fusion. The fusion of two lumbar vertebrae where the disc space of the spine is approached through the abdomen instead of through the lower back. Is performed through the front of the spine

PLIF: Posterior Lumbar Interbody Fusion. The fusion of two lumbar vertebrae where the disc space is approached through the lower back. Is performed through the back of the spine.

TLIF: Transforaminal Lumbar Interbody Fusion. Performed through the foramina (openings) of the spine.

DLIF: Direct Lateral Interbody Fusion. Performed from the side (lateral).

XLIF: Extreme Lateral Interbody Fusion. Performed through the side of the spine.

ACDF: Anterior Cervical Discectomy and Fusion. An anterior approach to removing a cervical herniated disc in order to relieve spinal cord or root pressure and alleviate corresponding pain, weakness, and numbness

ACCF: Anterior Cervical Corpectomy and Fusion.

Specify other:


http://www.spine-health.com/conditions/herniated-disc/cervical-herniated-disc-symptoms-and-treatment-options

http://www.spine-health.com/conditions/herniated-disc/cervical-herniated-disc-symptoms-and-treatment-options


If "Was arthrodesis performed?" is "Yes"

Which types of non-interbody arthrodesis? Check all that apply

Non-interbody: O Posterior O Posteriolateral O Facet fusion (lateral mass fusion) O Interlaminar fusion O Intertransverse process fusion O Interspinous process fusion O Others O None

Arthrodesis: The surgical immobilization of a joint so that the bones grow solidly together, also known as fusion.

Types:

Non-interbody arthrodesis cases are primarily posterior or posterolateral in type and the majority of the time this question may be answered by choosing one of these two answer options, which would be sufficient. However, these procedures are often described in more detail where an additional, more descriptive answer option could additionally be chosen. In those situations check all that apply by also checking:

• Facet fusion (lateral mass fusion); • Interlaminar fusion; • Intertransverse process fusion; or • Interspinous process fusion Intertransverse process: Between the transverse process of the vertebrae

Transverse process: A bony protrusion on either side of the arch of a vertebra, from the junction of the lamina and pedicle, which functions as a lever for attached muscles. For transverse process (right, left or both) choose “intertransverse process fusion.”

Facet fusion: Lumbar and lumbosacral fusion of the posterior column, posterior technique

Posteriolateral non-interbody fusion: Use this answer option for “augmentation” as that is how it’s done 99% of the time.

Also use posteriolateral non-interbody fusion for in situ arthrodesis.

Specify other:

If "Was arthrodesis used? is "Yes":

Number of disc spaces fused

Op Nt 1 through 13 1 disc space = 2 vertebral bodies and the intervening disc space. If there has been augmentation of prior fusions, count all newly done as well as all disc spaces which were redone.

If “Arthrodesis” is "Yes":

Did fusion cross the lumbar thoracic junction? (i.e. cross L1 to T10, 11 or 12)?

O Yes O No

The L1-T12 segment is the transition from a mobile segment of the spine, lumbar, to a rigid segment, thoracic.

If this procedure is an augmentation of a previous fusion, note “yes” only if this procedure crosses the lumbar thoracic junction, not if it is an augmentation of a procedure which previously stopped crossed the lumbar thoracic junction.



If “Arthrodesis” is “Yes”:

Does fusion stop at the L1 level?

O Yes O No

This includes any combination of lumbar fusion (L1-L5) that “stops dead” at the L1 vertebra and does not go beyond to T12, including into the disc space between L1 and T12. The L1-T12 segment is the transition from a mobile segment of the spine, lumbar, to a rigid segment, thoracic. If a fusion stops at L1 there is a greater risk for adjacent segment disease than if the fusion went beyond to T12 or stopped at L2.”

If this procedure is an augmentation of a previous fusion, note “yes” only if this procedure stops at L1, not if it is an augmentation of a procedure which previously stopped at L1.

Was instrumentation placed?

Op Nt O Yes O No

Medical devices used to provide additional spinal stability while helping the fusion set up.

If “Was instrumentation placed?” is “Yes”:

Were any of these types of instrumentation placed? Check all that apply.

•Pedicle screws •Facet screws (lumbar only) •Interspinous device (lumbar only) •Lateral mass screws/plating (cervical only) •Lateral lumbar plating (lumbar only) •Anterior lumbar plating (lumbar only) •Interbody device •Hooks (laminar or facet) •Plating for laminoplasty (cervical only) •Anterior cervical fixation plate (cervical only) •Laminar screws •Pars screws •Other

Pedicle screws (rods that accompany these screws are implied and do not need to be entered separately)

Facet screws (lumbar only) (there are no rods that accompany these screws)

Interspinous device (lumbar only) (there are no rods that accompany these devices)

Lateral mass screws/plating (cervical only) (rods and plates that accompany these are implied and do not need to be entered separately)

Lateral lumbar plating (lumbar only) (use only with lateral approach)

Anterior lumbar plating (lumbar only) (use only with anterior approach)

Interbody device (interbody expandable cages which go between the vertebral bodies; and corpectomy cages inserted to replace the vertebral body in the case of corpectomy - go here. There are usually no screws with cages.) (If posterior - there are no screws; if anterior there are sometimes screws; they also could be built in). Phalanges (as part of cages) do not need to be entered separately.

Hooks (laminar or facet) (rods that accompany these hooks are implied and do not need to be entered separately)

Plating for laminoplasty (cervical only) Anterior cervical fixation plate (cervical only)

(include zero profile here) Laminar screws Pars screws Other

FOR MSSIC PURPOSES: We will not be counting bone grafts as instrumentation.



If “Instrumentation - Check all that apply." is "Other":

Specify other

Op Nt

Was a bone graft used? Op Nt O Yes O No

In a spinal fusion, a solid bridge is formed between two vertebral segments in the spine to stop the movement in that section of the spine. Bone graft and/or bone graft substitute is needed to create the environment for the solid bridge to form.

If "Was a bone graft used?" is "Yes"

What type of bone graft was used?

Op Nt O Structural allograft O Non-structural allograft O Autograft O BMP O Synthetic O Not documented

Allograft: Cadaver bone harvested by a tissue bank for use in medical procedures. It provides a calcium base but does not have any bone-growth cells or proteins for use in stimulating new growth. Structural contains larger portions of intact bone, while non-structural does not. Structural allograft examples: Tricortical ilium blocks, fibular struts Non-structural allograft examples: Bioset allograft, Demineralized Bone Matrix Autograft: Bone taken from the patient themselves, usually from pelvis or hip and used as a graft in the process of fusing the spine. Autograft examples: Bone marrow aspirate BMP: Bone morphogenetic protein. These are proteins which naturally exist in the body. When placed in the area of the spine where fusion is desired they stimulate bone growth naturally. For more information about bone grafts see Section 4 of the ManOp. Synthetic: Synthetic bone grafts are made from calcium materials and are often called "ceramics." They are similar in shape and consistency to autograft bone. Ceramics have the advantage of being made without cadaver bone and are available in large amounts. NOTE: Abstractors should ask surgeons at their site which type(s) of bone grafts are typically used at their facility.

Discectomy Op Nt O Yes O No

Surgical removal of herniated disc material that presses on a nerve root or spinal cord. The procedure involves removing the central portion of an intervertebral disc (nucleus pulposus) which causes pain by stressing the spinal cord or radiating nerves. It tends to be done as microdiscectomy, which uses a special microscope to view the disc and nerves. This larger view allows the surgeon to use a smaller cut (incision).


http://www.spine-health.com/treatment/spinal-fusion/lumbar-spinal-fusion-surgery


Was intraoperative monitoring done?

Srg Sch Op Nt


Sensitive electrical testing performed during surgery to assess nerve function. If the type of monitoring is not documented, choose not documented.

If "Was intraoperative monitoring done?" is "Yes":


Srg Sch Op Nt

O EMG (electromyography monitoring) O MEP (motor evoked potential) O MMG (mechanomyography) O PediGuard (bone monitoring device) O SSEP (somatosensory evoked potential)

EMG (electromyography monitoring) MEP (motor evoked potential) MMG (mechanomyography) PediGuard (bone monitoring device) SSEP (somatosensory evoked potential)

Durotomy Op Nt O Yes O No

Incision of the dura mater, the outer-most membrane (of the 3 membranes) surrounding the brain and spinal cord. Note: Durotomy is captured here whether intentional or accidental. Regardless of intent the impact on outcome will be the same. Answer “yes” on Durotomy if CSF leak is present. This does not work in reverse. Do not automatically click CSF leak if Durotomy is present.

Did the patient have an unplanned ICU admission?

Flw Ch O Yes O No

This is based on initial stay. Do not include IMCU (Intermediate Care Unit) stays.

Did the patient have a prolonged intubation of more than 96 hours?

Anes Flw Ch

O Yes O No

The introduction of a tube through the trachea to prevent obstruction of the airway. Not restricted to initial stay. Include any within the 90 day postop period.

Did the patient have a CSF leak?

Prog DsSum

O Yes O No

CSF: Cerebrospinal fluid leak.

NOTE: Patients are often discharged before this becomes apparent. Still indicate here even if this is the case.



Was VTE prophylaxis ordered/given within 24 hours prior to surgical incision or within 24 hours after surgery end time?

VTEPr O Yes O No

For MSSIC purposes, “ordered/given within 24 hours” is interpreted to mean regardless of the date of the order. The order reads that VTE prophylaxis is ordered to be given within 24 hours prior to or after surgery. Or, that there is record that it was actually given within 24 hours prior to or after surgery. VTE prophylaxis: Protective or preventative treatment for the possibility of venous thromboembolism, a disease that includes both deep vein thrombosis (DVT) and/or pulmonary embolism (PE). For MSSIC purposes, consider the following to be appropriate VTE prophylaxis: O Low molecular weight heparin (LMWH) O Low dose unfractionated heparin (LDUH) O Adjusted-dose warfarin O Fondaparinux O Low dose aspirin O Mechanical prophylaxis - Sequential compression devices - Lower extremity exercise - IVC filters Compression stockings are NOT considered to be VTE prophylaxis.

If VTE prophylaxis order is "No":

If no, are medical reasons for not ordering or giving VTE prophylaxis documented?

VTEPr O Yes O No

VTE prophylaxis as defined above.

Was an IV antibiotic used (within 1 hour prior to cut time)?

PreOp MedAd

O Yes O No

If Vancomycin or fluoroquinolone were used and appropriately given within 2 hours prior to cut time answer “Yes.”

Was an antibiotic used intraoperatively?

Op Nt MedAd

O Yes O No

An antibiotic used during the operative procedure.

If "Was an antibiotic used intraoperatively?" is "Yes":

If an antibiotic was used intraoperatively, was method of administration... Check all that apply.

Op Nt MedAd

O IV O Powder O Irrigation

Method of administration of the antibiotic used during the operative procedure. IV here refers to IV antibiotic ordered to be re-administered during surgery, not those begun preoperatively and continued during surgery as ordered preoperatively.



Were postop antibiotics administered?

MedAd O Yes O No

Antibiotics administered after final closure, orally or by IV.

If "Were postop antibiotics administered?" is "Yes":

Was the postop antibiotic discontinued …

Flw Ch O Less than or equal to 24 hours post-surgery O Greater than 24 hours post-surgery

Was a drain left in place postoperatively?

Op Nt Flw Ch

O Yes O No

Any percutaneous drain inserted during the operative procedure.

If "Was a drain left in place postoperatively?" is "Yes":

Was an IV antibiotic continued until the drain was removed?

Flw Ch Prog

O Yes O No

Example: An antibiotic prescribed every 6 hrs that was given at 8:00am, should be considered as coverage until 2:00pm. If drain is removed prior to 2:00 pm then the answer to this variable would be “YES”.


O Yes O No



Tab Name: Admissions NOTE: Clinic Record Not Available answer options are for records where surgeons/clinics have refused to grant access to the clinic record for post-surgical chart abstraction. The Coordinating Center should be notified of surgeons whose records fall into this category. DO NOT USE the answer option “Clinic Record Not Available” for any other purpose.

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Date of Surgical Admission Chart Abstraction

Date of Admission DsSum The timing of the stay begins with the “official” admission or the date of procedure, whichever comes first. For example:

If Outpatient procedure use the date of arrival/discharge.

If Inpatient procedure use date of actual admission and discharge.

If ER stay or observation proceeded DO NOT INCLUDE.

Date of Discharge DsSum

Length of Stay (days) (auto calculated)

Does the record show the first day the patient was up and walking after surgery?

Flw Ch Prog

O Yes O No O Not applicable

Walking any distance (assisted or unassisted). Do not count “transfers” to bed or chair. If patient came in not walking and are discharged not walking document as “not applicable”.

If "Does the record show the first day the patient was up and walking after surgery?" is Yes":

On what day did the patient get up and walk?

Flw Ch Prog

If this is not expressly documented but it is hospital practice only to discharge outpatient procedures same day if the patient has been able to walk to the restroom for example, ask the surgeon champion to document the practice in writing for audit purposes and then answer the question appropriately as “Yes.”

Was the patient walking upon discharge?

Flw Ch Prog

O Yes O No O Not applicable O Not documented

Do not assume “walking” on discharge if it is not expressly documented. If this is not expressly documented but it is hospital practice only to discharge outpatient procedures if the patient has been able to walk to the restroom for example, ask the surgeon champion to document the practice in writing for audit purposes and then answer the question appropriately as “Yes.” If patient came in not walking and are discharged not walking document as “not applicable”.


Appendix L - Master Variable List – Lumbar Module Tab Name: Admissions

Was there an unplanned return to OR on this admission?

Chart Review

O Yes O No

Do not include returns to OR for purely diagnostic testing. Example, CT spine myelograms done in the OR. Additionally, unplanned returns to OR on initial admit should not be counted later as “returns to OR within 90 days of surgery.”

If "Was there an unplanned return to OR on this admission?" is "Yes":

Date of unplanned return to OR

Chart Review

If "Was there an unplanned returned to OR on this admission?" is "Yes":

Primary reason for unplanned return to the OR

Chart Review

O Hematoma O CSF leak O Infection O Wound dehiscence O Revised implants O Wrong level surgery O Recurrent disc herniation O Hardware failure O Other

If "Primary reason for unplanned return to the OR" is "Other":

Specify Other:

Chart Review

If “Was there an unplanned return to OR on this admission?” is “Yes”:

Was there a second unplanned return to OR on this admission?

Chart Review

O Yes O No


If "Was there a second unplanned return to OR on this admission?" is "Yes":

Date of second unplanned return to OR

Chart Review

If "Was there a second unplanned returned to OR on this admission?" is "Yes":

Primary reason for second unplanned return to the OR

Chart Review


If "Primary reason for second unplanned return to the OR" is "Other":

Specify Other:

Chart Review



If "Was there a second unplanned return to OR on this admission?" is "Yes":

Was there a third unplanned return to OR on this admission?

Chart Review

O Yes O No


If "Was there a third unplanned return to OR on this admission?" is "Yes":

Date of third unplanned return to OR

Chart Review

If "Was there a third unplanned return to OR on this admission?" is "Yes":

Primary reason for third unplanned return to the OR

Chart Review


If "Primary reason for third unplanned return to the OR" is "Other":

Specify Other:

Chart Review

Place discharged to DsSum O Home routine O Home with home healthcare services O Transferred to another acute care facility O Against medical advice or AMA O Died in hospital O Discharged alive, destination unknown O Skilled nursing facility O Intermediate/rehabilitation care facility O Another type of facility

Intermediate/rehabilitation care facility: Under this answer option include Inpatient Rehabilitation Facilities (synonymous with Subacute Rehabilitation, or SAR) Another type of facility: Choose this answer option for “Long Term Care Facilities” (LTAC) Clarifying Note: The “where” or type of facility is the answer here; not the “what” or type of care ordered.

If "Place Discharged to" is "Another type of facility":

Specify other

DsSum

“Did the patient develop any of the following complications within 90 days of surgery, which have not been previously noted on a prior recent surgery?”

NOTE: If this is a subsequent surgery (-1, -2, etc.) and this complication, or the readmissions, or returns to OR that follow, have previously been noted on the index (original) or most recent previous surgery, do not duplicate the collection of this incidence by also marking “yes.” Leave only one entry per complication in the registry.



Axial Pain (back/neck pain) (New or worsening)

DsSum Chart Review

O Yes O No O Clinic Record Not Available


Deep Vein Thrombosis (DVT)

DsSum Chart Review


The identification of a new blood clot or thrombus within the venous system, which may be coupled with inflammation. This diagnosis is confirmed by a duplex, venogram or CT scan.

Pulmonary Embolism (PE) DsSum Chart Review


Lodging of a foreign object, most often a blood clot in, a pulmonary artery with subsequent obstruction of blood supply to the lung parenchyma. Indicate "Yes" if found in Discharge Summary or Billing Report, otherwise "No."

Myocardial Infarction (MI)

DsSum Chart Review


Gross necrosis of the myocardium, due to interruption of the blood supply to the area; commonly referred to as a heart attack. An acute myocardial infarction as manifested by one of the following: * Documentation of ECG changes indicative of acute MI (one or more of the following): * ST elevation > 1 mm in two or more contiguous leads * New left bundle branch * New q-wave in two or more contiguous leads * New elevation in troponin greater than 3 times upper level of the reference range in the setting of suspected myocardial ischemia. Physician diagnosis of myocardial infarction.

Urinary Tract Infection (UTI)

DsSum Chart Review


Determine UTI if:

The UTI was not present on admission and

A diagnosis was made determined from a positive urine culture or urinalysis. and

Patient received treatment with an antibiotic

Suggested Data Sources: Surgeon’s post procedure office notes, EMR-lab, radiology, progress notes, in hospital coding.



Was there a surgical site infection according to the CDC definition?


FOR MSSIC PURPOSES – while we are using CDC definitions, we are looking for superficial OR deep infections from 0-90 days. Note that to alleviate confusion the CDC notations regarding anything less than 90 days have been crossed off with MSSIC-appropriate timeline added in italics. Superficial incisional SSI Must meet the following criteria: Infection occurs within 30 or 90 days (where day 1 = the procedure date) AND involves only skin and subcutaneous tissue of the incision AND patient has at least one of the following:

a. purulent drainage from the superficial incision. b. organisms isolated from an aseptically-obtained culture from the superficial incision or subcutaneous tissue. c. superficial incision that is deliberately opened by a surgeon, attending physician** or other designee and is culture positive or not cultured AND patient has at least one of the following signs or symptoms: pain or tenderness; localized swelling; erythema; or heat. A culture negative finding does not meet this criterion. d. diagnosis of a superficial incisional SSI by the surgeon or attending physician** or other designee.

The following does not qualify as criteria for the definition of superficial SSI: * Stitch abscess (minimal inflammation and discharge confined to the points of suture penetration) Deep incisional SSI Must meet the following criteria: Infection occurs within 30 or 90 days (where day 1 = the procedure date) AND involves deep soft tissues of the incision (e.g., fascial and muscle layers) AND patient has at least one of the following:

a. purulent drainage from the deep incision. b. a deep incision that spontaneously dehisces, or is deliberately opened or



aspirated by a surgeon, attending physician** or other designee and is culture positive or not cultured AND patient has at least one of the following signs or symptoms: fever (>38°C); localized pain or tenderness. A culture negative finding does not meet this criterion. c. an abscess or other evidence of infection involving the deep incision that is detected on gross anatomical or histopathologic exam, or imaging test.

** The term attending physician for the application of the SSI criteria may be interpreted to mean the surgeon(s), infectious disease, other physician on the case, emergency physician or physician’s designee (nurse practitioner or physician’s assistant).

If “Yes” on SSI:

Was the surgical site infection superficial or deep as defined by the CDC definition?

O Superficial O Deep O Clinic Record Not Available

If "Surgical Site Infection" is "Yes":

Was the infection identified as MRSA?

DsSum Chart Review


Methicillin-resistant Staphylococcus aureus: Any of several bacterial strains of the genus Staphylococcus (S. aureus) that are resistant to beta-lactam antibiotics (as methicillin and nafcillin) and that are typically benign colonizers of the skin and mucous membranes (as of the nostrils) but may cause severe infections (as by entrance through a surgical wound) especially in immunocompromised individuals. NOTE: The reason MSSIC asks about only MRSA is that it is a more virulent organism and harder to treat, so it’s a public health issue of special interest. Infections like MSSA are easily treated, and are not as big of a concern as MRSA from a societal perspective. The costs of treating a MRSA infection are also substantially higher.

If "Surgical Site Infection" is "Yes":

Treatment for surgical site infection Check all that apply

DsSum Chart Review

O Intravenous (IV) antibiotics O Surgical incision and drainage O Oral Antibiotics O No treatment O Clinic Record Not Available



Clinically significant Urinary retention

DsSum Chart Review


Answer “yes” only if one or more of the 5 situations found on the branching question apply and the urinary retention is “new or worsening” as opposed to pre-existing. Note: Existence of benign prostatic hypertrophy (BPH) does not count as pre-existing urinary retention. o Discharged with urinary catheterization o Three or more straight catheterizations postoperatively, with one or more catheterizations being beyond 48 hours (48 hours starts once patient hits the PACU) o Documentation of extended stay due to urinary retention o Insertion of Foley for urinary retention o None of the above apply, but surgeon documents urinary retention

If “Clinically significant urinary retention” is “Yes”:

Treatment stemming from Urinary Retention Check all that apply:

O Discharged with urinary catheterization O Three or more catheterizations postoperatively, with one or more catheterizations being beyond 48 hours (48 hours starts once patient hits the PACU) O Documentation of extended stay due to urinary retention O Insertion/Reinsertion of Foley for urinary retention O None of the above apply, but surgeon documents urinary retention

Ileus DsSum Chart Review


Obstruction of the bowel.

Wound dehiscence DsSum Chart Review


The parting of the sutured lips of a surgical wound. Choose this answer option if the dehiscence required return to OR, re-admission, or treatment with antibiotics for associated infection.

Surgical Site Hematoma DsSum Chart Review


A mass of usually clotted blood that forms in a tissue, organ, or body space as a result of a broken blood vessel, appearing at the site of the surgery.

Myelopathy (New or worsening)

DsSum Chart Review


A set of symptoms and signs consistent with spinal cord dysfunction. This is best left to the surgeons to diagnose/document. Do not rely on coding references to “with myelopathy” if the surgeon does not otherwise make reference to myelopathy.

NOTE: For MSSIC purposes Abstractors should consider the presence of myelopathy indicated when myelomalacia is mentioned in the record.



Neurogenic Claudication (New or worsening)

DsSum Chart Review


A common symptom of spinal stenosis, or inflammation of the nerves emanating from the spinal cord. Neurogenic refers to the problem having its origin at a nerve, and claudication is from the Latin word for limp, because the patient feels a painful cramping or weakness in the legs. If “shopping cart syndrome” is seen, the abstractor may dig deeper into the record or check with the surgeon, but do not document “yes” on neurogenic claudication based on the notation of shopping cart syndrome alone. Surgeons should document neurogenic claudication.

Neurogenic Bowel or Bladder Dysfunction (New or worsening)

DsSum Chart Review


A dysfunction of the urinary bladder or bowel due to disease of the central nervous system or peripheral nerves involved in the control of micturition (urination) and defecation.

A new neurologic deficit (CVA) with confirmation of stroke on MRI (OR CT)

DsSum Chart Review


Cerebrovascular accident (stroke) is a sudden diminution or loss of consciousness, sensation, and voluntary motion caused by rupture or obstruction (as by a clot) of a blood vessel of the brain.

A new spine-related lower extremity motor deficit (not CVA)

DsSum Chart Review


A lack or impairment of muscle function in the legs - not related to cerebrovascular accident.

A new neuro deficit related to cervical spinal cord or nerve injury

DsSum Chart Review


A lack or impairment of muscle function in the extremities - not related to cerebrovascular accident.

Weakness (New or worsening)

DsSum Chart Review


Weakness: For MSSIC purposes, weakness reported by patient only, but not documented (either by report or exam) by the surgeon or staff, is not currently being collected in this registry. In this section, for post-surgical references to “weakness” please include any motor weakness – regardless of location of weakness or location of surgery. (i.e. include arm weakness for Lumbar surgeries)



Radicular Findings (New or worsening)

DsSum Chart Review


Radicular symptoms or radiculitis: Numbness, tingling, pain, or weakness "radiated" along the dermatome (sensory distribution) of a nerve due to compression, inflammation or other irritation of the nerve root (radiculopathy) at its connection to the spinal column. Note: Surgeons do not always use the phrase “nerve root” to document radicular symptoms. Dermatome: A Dermatome is the area of sensory nerves near the skin that are supplied by a specific spinal nerve root. The body can be divided into regions that are mainly supplied by a single spinal nerve. There are eight cervical (one for the head, and one for each cervical vertebra), twelve thoracic, five lumbar and five sacral spinal nerves. Dermatomes are useful for finding the site of damage to the spine. For example, leg pain from radiculopathy often indicates a problem to a specific nerve root in the lumbar spine. A Dermatome diagram is available as Appendix L (Pictures and Diagrams of Spine Anatomy) to the MSSIC Manual of Operations.

If "Radicular Findings" is "Yes":


DsSum Chart Review

O Numbness/tingling O Pain O Weakness O Clinic Record Not Available

Weakness: For MSSIC purposes, weakness reported by patient only, but not documented (either by report or exam) by the surgeon or staff, is not currently being collected in this registry. In this section, for post-surgical references to “weakness” please include any motor weakness – regardless of location of weakness or location of surgery. (i.e. include arm weakness for Lumbar surgeries)

Patient died within 90 days of surgery

DsSum Chart Review


Cause of death DsSum Chart Review

If not documented - state "Not documented"

Was the patient re-admitted to the hospital within 90 days of surgery?

Chart Review


Observation is not an admission. Do not count psychiatric admissions. NOTE: Sites that are part of a health system where the abstractor has access to readmit information at “sister hospitals” should include information regarding readmits gained through this combined medical record. If it is dictated by surgeon that the patient stated that they were hospitalized at another facility choose “yes” even if those medical records are not accessible.



If "Was the patient re-admitted to the hospital within 90 days of surgery?" is "Yes":

Was the re-admission part of a planned multi-stage procedure?

Chart Review


Planned multi-stage procedures will not be counted among the readmits for reporting purposes in MSSIC.


Date of re-admission

If "Was the re-admission part of a planned multi-stage procedure?" is "Yes":

Was this re-admission related to any of the previously noted complications?

Chart Review

O Deep vein thrombosis (DVT) O Pulmonary embolism (PE) O Myocardial infarction (MI) O Urinary tract infection (UTI) O Urinary retention O Surgical site infection(SSI) O Surgical site hematoma O Neurogenic bowel or bladder dysfunction O A new neurologic deficit (CVA) with confirmation of stroke on MRI O A new spine-related lower extremity motor deficit (not CVA) O A new neuro deficit related to cervical spinal cord or nerve injury O A new spine-related radicular finding of numbness, pain, or weakness O Pain O Other O Not related to previously noted complications O Clinic Record Not Available

If "Was this re-admission related to any of the previously noted complications? " is "Not related to previously noted complications":

What is the reason for this readmission?




Was there a second re-admission for this patient within 90 days of surgery?

Chart Review



If "Was there a second re-admission for this patient within 90 days of surgery?" is "Yes":


Chart Review



If “Was there a second re-admission for this patient…” is “yes”:


If "Was this second re-admission part of a planned multi-stage procedure?" is "Yes":

Was this second re-admission related to any of the previously noted complications?

Chart Review

O Deep vein thrombosis (DVT) O Pulmonary embolism (PE) O Myocardial infarction (MI) O Urinary tract infection (UTI) O Urinary retention O Surgical site infection(SSI) O Surgical site hematoma O Neurogenic bowel or bladder dysfunction O A new neurologic deficit (CVA) with confirmation of stroke on MRI O A new spine-related lower extremity motor deficit (not CVA) O A new neuro deficit related to cervical spinal cord or nerve injury O A new spine-related radicular finding of numbness, pain, or weakness O Pain O Other O Not related to previously noted complications O Clinic Record Not Available



If "Was this second re-admission related to any of the previously noted complications? " is "Not related to previously noted complications":

What is the reason for this second readmission?

If "Was there a second re-admission within 90 days of surgery?" is "Yes":

Was there a third re-admission for this patient within 90 days of surgery?

Chart Review



If "Was there a third re-admission for this patient within 90 days of surgery?" is "Yes":


Chart Review



If “Was there a third re-admission for this patient…” is “yes”:


Chart Review



If "Was this third re-admission part of a planned multi-stage procedure?" is "Yes":

Was this third re-admission related to any of the previously noted complications?

Chart Review

O Deep vein thrombosis (DVT) O Pulmonary embolism (PE) O Myocardial infarction (MI) O Urinary tract infection (UTI) O Urinary retention O Surgical site infection (SSI) O Surgical site hematoma O Neurogenic bowel or bladder dysfunction O A new neurologic deficit (CVA) with confirmation of stroke on MRI O A new spine-related lower extremity motor deficit (not CVA) O A new neuro deficit related to cervical spinal cord or nerve injury O A new spine-related radicular finding of numbness, pain, or weakness O Pain O Other O Not related to previously noted complications O Clinic Record Not Available

If "Was this third re-admission related to any of the previously noted complications?" is "Not related to previously noted complications":

What is the reason for this third readmission?

Did the patient return to the OR within 90 days of surgery?

Chart Review


If "Did the patient return to OR within 90 days of surgery?" is "Yes":

Date of Return to OR

If "Did the patient return to OR within 90 days of surgery?" is "Yes":

Primary reason for return to the OR

Chart Review

O Hematoma O CSF leak O Infection O Wound dehiscence O Revised implants O Wrong level surgery O Recurrent disc herniation O Hardware failure O Planned multi-stage procedure O Pain O Other O Clinic Record Not Available

If "Reason for return to the OR" is "Other":

Chart Review



Specify other:

If “Did the patient return to OR within 90 days of surgery?" is "Yes":

Was there a second return to OR within 90 days of surgery?

Chart Review


If "Was there a second return to OR within 90 days of surgery?" is "Yes":

Date of second return to OR

Chart Review

If "Was there a second return to OR within 90 days of surgery?" is "Yes":

Primary reason for second return to the OR

Chart Review


If "Reason for return to OR" is "Other":

Specify other

Chart Review

If "Was there a second re-admission for this patient within 90 days of surgery?" is "Yes":

Did the patient have a third return to OR within 90 days of surgery?

Chart Review


If "Did the patient have a third return to OR within 90 days of surgery?" is "Yes":

Date of third return to OR

Chart Review

If "Did the patient have a third return to OR within 90 days of surgery?" is "Yes":

Primary reason for third return to the OR

Chart Review




If "Reason for return to the OR" is "Other":

Specify other

Chart Review


O Yes O No


Appendix L Master Variable List – Lumbar Module Tab Name: POST-OP QUESTIONNAIRE (Highlighted variables appear on lumbar module only)


Follow-Up Questionnaire Time Interval (How long has it been since your last surgery?)

O 90 Days O 1 Year O 2 Years

Date of Questionnaire Date auto-populates for patients using web portal.

Person entering "patient-provided" data in registry

O Abstractor O Patient - through web-portal

Which answer best represents your level of satisfaction with your surgical outcome?

O Surgery met my expectations O I did not improve as much as I had hoped but I would undergo the same operation for the same results O Surgery helped but I would not undergo the same operation for the same results O I am the same or worse as compared to before the surgery

Please describe your back and leg pain when off your pain medication. Please rate your back pain and leg pain on a scale of 0 to 10, where zero (0) would mean "no pain" and a ten (10) would mean "worst pain imaginable." For example, describe your pain when you are off your medication, after your pain medication has worn off, when you are due to take your next pill, that is please describe how your pain would feel if you were not on pain medication.

Note: If the patient states that they do not have pain so the question does not apply and they don’t know how to answer they are free to skip the question and other questions that refer to pain.

Please rate your back pain on a scale of 0 to 10 over the past 7 days.


Now, please rate your leg pain on a scale of 0 to 10 over the past 7 days.



Appendix L - Master Variable List – Lumbar Module Tab Name: Post-Op Questionnaire


This questionnaire is designed to give us information as to how your back (or leg) trouble affects your ability to manage in everyday life. Please answer every section. Mark one box only in each section that most closely describes you today.

Section 1 - Pain intensity O I have no pain at the moment O The pain is very mild at the moment O The pain is moderate at the moment O The pain is fairly severe at the moment O The pain is very severe at the moment O The pain is the worst imaginable at the moment

Section 2 - Personal care (washing, dressing, etc.)

O I can look after myself normally without causing extra pain O I can look after myself normally but it is very painful O It is painful to look after myself and I am slow and careful O I need some help but manage most of my personal care O I need help every day in most aspects of self care O I do not get dressed, wash with difficulty and stay in bed

Section 3 - Lifting O I can lift heavy weights without extra pain O I can lift heavy weights but it gives extra pain O Pain prevents me from lifting heavy weights off the floor but I can manage if they are conveniently positioned, e.g. on a table O Pain prevents me from lifting heavy weights but I can manage light to medium weights if they are conveniently positioned O I can lift only very light weights O I cannot lift or carry anything at all




Section 4 - Walking O Pain does not prevent me walking any distance O Pain prevents me walking more than one mile O Pain prevents me walking more than a quarter of a mile O Pain prevents me walking more than 100 yards O I can only walk using a stick or crutches O I am in bed most of the time and have to crawl to the toilet

Section 5 - Sitting O I can sit in any chair as long as I like O I can sit in my favorite chair as long as I like O Pain prevents me from sitting for more than 1 hour O Pain prevents me from sitting for more than half an hour O Pain prevents me from sitting for more than 10 minutes O Pain prevents me from sitting at all

Section 6 - Standing O I can stand as long as I want without extra pain O I can stand as long as I want but it gives me extra pain O Pain prevents me from standing for more than 1 hour O Pain prevents me from standing for more than half an hour O Pain prevents me from standing for more than 10 minutes O Pain prevents me from standing at all

Section 7 - Sleeping O My sleep is never disturbed by pain O My sleep is occasionally disturbed by pain O Because of pain I have less than 6 hours sleep O Because of pain I have less than 4 hours sleep O Because of pain I have less than 2 hours sleep O Pain prevents me from sleeping at all

Section 8 - Sex life (if applicable) O My sex life is normal and causes no extra pain O My sex life is normal but causes some extra pain O My sex life is nearly normal but it is very painful O My sex life is severely restricted by pain O My sex life is nearly absent because of pain O Pain prevents any sex life at all

Note: Leave blank if not active or decline. The Oswestry will score with some questions left blank.




Section 9 - Social life O My social life is normal and causes me no extra pain O My social life is normal but increases the degree of pain O Pain has no significant effect on my social life apart from limiting my more energetic interests, e.g. sports, etc. O Pain has restricted my social life and I do not go out as often O Pain has restricted social life to my home O I have no social life because of pain

Section 10 - Traveling O I can travel anywhere without pain O I can travel anywhere but it gives extra pain O Pain is bad but I manage journeys over two hours O Pain restricts me to journeys of less than one hour O Pain restricts me to short necessary journeys under 30 minutes O Pain prevents me from traveling except to receive treatment

Total ODI Sum Score (auto calculated)

Quality of Life (EQ-5D)

By marking the one box in each group below, please indicate which statements best describe your own health state today.

Mobility O I have no problems in walking about O I have some problems in walking about O I am confined to bed

Self-Care O I have no problems with self-care O I have some problems washing or dressing myself O I am unable to wash or dress myself

Usual Activities (e.g. work, study, housework, family or leisure activities)

O I have no problems with performing my usual activities O I have some problems with performing my usual activities O I am unable to perform my usual activities

Pain/Discomfort O I have no pain or discomfort O I have moderate pain or discomfort O I have extreme pain or discomfort




Anxiety/Depression O I am not anxious or depressed O I am moderately anxious or depressed O I am extremely anxious or depressed

EQ-5D Score (auto calculated)

To help people say how good or bad a health state is, we have drawn a scale (rather like a thermometer) on which the best state you can imagine is marked 100 and the worst state you can imagine is marked 0. We would like you to indicate on this scale how good or bad your own health is today, in your opinion. Please do this by choosing a number on the scale to indicate how your health is TODAY. Now, please enter the number you chose on the scale in the box provided.

0 through 100

Have you been able to return to your previous activities since your operation?

O Yes O No

Over the last 2 weeks, how often have you been bothered by any of the following problems?

1. Little interest or pleasure in doing things


2. Feeling down, depressed, or hopeless


Were you able to return to work after your operation?

O Yes Full-time O Yes Part-time O No O Not applicable




If "Were you able to return to work after your operation? Is "Yes - Full time, or Yes - Part-time"

Date you returned to work

Are you working currently? O Yes - Full-time O Yes - Part-time O No O Retired O Volunteering O On disability

If "Are you working currently?” is “Yes - Part-time":

Is this part-time status because of your neck or back problems?

O Yes O No

If "Follow-Up Questionnaire Time Frame is 90 Days": Were you given (or asked to get) a special pre-surgical skin preparation kit or wash to use at home the day prior to your surgery?

O Yes O No

If the surgery was an emergency procedure and there was no time – answer “No”. Use of “Dial” soap should not be counted as a “Yes” here.

If "Were you given…." is "Yes":

Did you use it?

O Yes O No

Since your surgery, have you experienced shooting pain below the knee?

O Yes O No

If "Follow-up Questionnaire Time Period" is 90 Days: Were you readmitted to the hospital (surgery center) within 90 days of discharge?

O Yes O No

If patient indicates readmission this should prompt abstractor to look for documentation of the readmission but do not mark chart abstracted variable “readmission” as “yes” based on patient report.

If "Follow-up Questionnaire Time Period" is 1 Year: Were you readmitted to the hospital (surgery center) during the last 9 months, since you last filled out a questionnaire?

O Yes O No

If "Follow-up Questionnaire Time Period" is 2 Years: Were you readmitted to the hospital (surgery center) during the last year, since you last filled out a questionnaire?

O Yes O No




If "Were you readmitted to the hospital (surgery center) …?" is "Yes":

Reason for the readmit

O Deep venous thrombus/blood clot (DVT) O Pulmonary embolism (PE) O Myocardial infarction (MI) O Stroke (CVA) O Urinary tract infection (UTI) O Surgical site infection or wound dehiscence (SSI) O Surgical site hematoma O Unsure O Other

If "Reason for the readmit" is "Other":

Specify other

Did you require revision surgery? O Yes O No

If "Did you require revision surgery?" is "Yes":

Date of revision surgery:

If "Follow-up Questionnaire Time Period" is 90 Days or 1 Year: What is your preference for future contact for this study?

O E-mails with access to web-based questionnaires O Telephone calls with questionnaires by interview process O Mailings with paper questionnaires to be returned

NOTE: This question (as well as the branching email address question below) does not appear on the Postop Questionnaire Tab, but is provided on case report forms for distribution to patients. If a change is made it needs to be made on the Baseline Questionnaire Tab.

If "What is your preference for future contact for this study?" is "E-mails ….":

Email Address

Here enter the e-mail address which will be used to contact the patient for the purposes of instructing them on use of the MSSIC Patient Portal for completing patient questionnaires.

Tab/Questionnaire/Task is complete:

O Complete (to the extent the patient was willing to answer) O Incomplete (last surgery was too recent) O Incomplete (patient refused) O Incomplete - Patient did not follow through (paper version not returned/didn’t log in to web portal) O Incomplete (unable to contact patient/questionnaire window closed) O Incomplete (no current contact info) O Incomplete (patient does not speak English/language barrier) O Patient is incapacitated (in nursing home or hospital, or unable to respond)

Patient did not follow through may be used when patient did not return questionnaire or log into site after seeming to agree to comply. Use "No response at current phone/address" if attempts have been made in accordance with MSSIC guidelines (3 contact attempts). Verification of incapacitated status should be documented in notes in Patient Registry Crosswalk. Incapacitated includes dementia patients.
