Outcome Measurements for Minimally Invasive Percutaneous Spine Techniques

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Chapter 38 Outcome Measurements for Minimally Invasive Percutaneous Spine Techniques

Kyung-Hoon Kim, MD, PhD, Cheul-Hong Kim, MD, PhD

Various outcome scales

There are various outcome scales for measuring the results of minimal invasive percutaneous spine procedures. The most commonly used of these scales are presented in this chapter.

Table 38.1 A Proposed Set of Patient-Based Outcome Measures for Use in Spinal Disorders

image

Back-specific function measures

BOX 38-1 Selected Back-Specific Functional Instruments

Oswestry Low Back Pain Disability Questionnaire (ODQ)

Roland Morris Disability Questionnaire (RMDQ)

Million Visual Analogue Scale (MVAS)

Waddell Disability Index (WDI)

Low Back Outcome Score (LBOS)

Clinical Back Pain Questionnaire (CBPQ; Aberdeen Low Back Pain Scale)

Low Back Pain Rating Scale (LBPRS)

Quebec Back Pain Disability Scale (QBPDS)

North American Spine Society Lumbar Spine Questionnaire (NASS LSQ)

Resumption of Activities of Daily Living Scale (RADL)

Scoring System for Low Back Pain Proposed by Japanese Orthopaedic Association (JOA)

Table 38.2 Descriptive Information for Selected Back-Specific Functional Instruments

image

Table 38.3 Comparison between Roland Morris Disability Questionnaire and Oswestry Low Back Pain Disability Questionnaire (ODQ)

image

BOX 38-2 The Roland Morris Disability Questionnaire (RDQ)* [1]

When your back hurts, you may find it difficult to do some things you normally do. This list contains sentences that people have used to describe themselves when they have back pain. When you read them, you may find that some stand out because they describe you today. As you read the list, think of yourself today. When you read a sentence that describes you today, put a tick against it. If the sentence does not describe you, then leave the space blank and go on to the next one. Remember; only tick the sentence if you are sure it describes you today.

1. I stay at home most of the time because of my back.
2. I change position frequently to try and get my back comfortable.
3. I walk more slowly than usual because of my back.
4. Because of my back I am not doing any of the jobs that I usually do around the house.
5. Because of my back, I use a handrail to get upstairs.
6. Because of my back, I lie down to rest more often.
7. Because of my back, I have to hold on to something to get out of an easy chair.
8. Because of my back, I try to get other people to do things for me.
9. I get dressed more slowly than usual because of my back.
10. I only stand for short periods of time because of my back.
11. Because of my back, I try not to bend or kneel down.
12. I find it difficult to get out of a chair because of my back.
13. My back is painful almost all the time.
14. I find it difficult to turn over in bed because of my back.
15. My appetite is not very good because of my back pain.
16. I have trouble putting on my socks (or stockings) because of the pain in my back.
17. I only walk short distances because of my back.
18. I sleep less well on my back.
19. Because of my back pain, I get dressed with help from someone else.
20. I sit down for most of the day because of my back.
21. I avoid heavy jobs around the house because of my back.
22. Because of my back pain, I am more irritable and bad tempered with people than usual.
23. Because of my back, I go upstairs more slowly than usual.
24. I stay in bed most of the time because of my back.

* The score is the total number of items checked—i.e., from a minimum of 0 to a maximum of 24.

BOX 38-3 Oswestry Low Back Pain Disability Questionnaire (ODQ) [2]

Could you please complete this questionnaire? It is designed to give us information as to how your back (or leg) trouble has affected 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

image I have no pain at the moment.
image The pain is very mild at the moment.
image The pain is moderate at the moment.
image The pain is fairly severe at the moment.
image The pain is very severe at the moment.
image The pain is the worst imaginable at the moment.

Section 2: Personal Care (washing, dressing, etc.)

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

Section 3: Lifting

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

Section 4: Walking

image Pain does not prevent me walking any distance.
image Pain prevents me walking more than 1 mile.
image Pain prevents me walking more than a quarter of a mile.
image Pain prevents me walking more than 100 yards.
image I can only walk using a stick or crutches.
image I am in bed most of the time and have to crawl to the toilet.

Section 5: Sitting

image I can sit in any chair as long as I like.
image I can sit in my favorite chair as long as I like.
image Pain prevents me from sitting for more than 1 hour.
image Pain prevents me from sitting for more than half an hour.
image Pain prevents me from sitting for more than 10 minutes.
image Pain prevents me from sitting at all.

Section 6: Standing

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

Section 7: Sleeping

image My sleep is never disturbed by pain.
image My sleep is occasionally disturbed by pain.
image Because of pain I have less than 6 hours’ sleep.
image Because of pain I have less than 4 hours’ sleep.
image Because of pain I have less than 2 hours’ sleep.
image Pain prevents me from sleeping at all.

Section 8: Sex Life (if applicable)

image My sex life is normal and causes no extra pain.
image My sex life is normal but causes some extra pain.
image My sex life is nearly normal but is very painful.
image My sex life is severely restricted by pain.
image My sex life is nearly absent because of pain.

Section 9: Social Life

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

Section 10: Traveling

image I can travel anywhere without pain.
image I can travel anywhere but it gives extra pain.
image Pain is bad but I manage journeys over 2 hours.
image Pain restricts me to journeys of less than 1 hour.
image Pain restricts me to short necessary journeys under 30 minutes.
image Pain prevents me from traveling except to receive treatment.

For each section of six statements the total score is 5; if the first statement is marked, the score is 0; if the last statement is marked, it is 5. Intervening statements are scored according to rank. If more than one box is marked in each section, take the highest score. If all 10 sections are completed the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) × 100 = 32%. If one section is missed (or not applicable) the score is calculated: Example: 16 (total scored)/45 (total possible score) × 100 = 35.5%. Therefore, the final score may be summarized as: total score/(5 × number of questions answered) × 100%. We suggest rounding the percentage to a whole number for convenience.

Table 38.4 Scoring System for Low Back Pain Proposed by Japanese Orthopaedic Association (Maximum 15 Points)

Subjective Symptoms (Maximum 9 Points)
I. Low back pain

3 None   2 Occasional mild pain   1 Frequent mild or occasional severe pain   0 Frequent or continuous severe pain
II. Leg pain and/or tingling
3 None   2 Occasional slight symptoms   1 Frequent mild or occasional severe symptoms   0 Frequent or continuous severe symptoms
III. Gait
3 Normal   2 Able to walk farther than 500 m although resulting in pain, tingling, and/or muscle weakness   1 Unable to walk farther than 500 m owing to leg pain, tingling, and/or muscle weakness   0 Unable to walk farther than 100 m owing to leg pain, tingling, and/or muscle weakness Clinical Signs (Maximum 6 Points)
IV. Straight-leg raising
2 Normal   1 30-70 degrees   0 to less than 30 degrees
V. Sensory disturbance
2 None   1 Slight   0 Marked
VI. Motor disturbance
2 None (5/5)   1 Slight (4/5)   0 Marked (3-0/5)

Data from Subcommittee on Low Back Pain and Cervical Myelopathy Evaluation of the Clinical Outcome Committee of the Japanese Orthopaedic Association, Japan. Japanese Orthopaedic Association Back Pain Evaluation Questionnaire. Part 3. Validity study and establishment of the measurement scale. Journal of Orthopaedic Science. 2008; 13(3): 173-179. 5-0 is muscle strength rating with 5 as normal and 0 as no contraction.

Generic health status measures

Table 38.5 Low Back Version of the SF-36 Physical Functioning Scale [2]

image

Pain

Table 38.6 The Strengths and Weaknesses of Alternative Measures of Pain Intensity

Scale Strengths Weakness(es)
Verbal Rating Scale (VRS)
Easy to administer
Easy to score
Good evidence for construct validity
Compliance with measurement task is high
May approximate ratio scaling of cross-modality matching
(or scores developed from cross-modality matching methods) are used

Can be difficult for persons with limited vocabulary
Relatively few response categories compared with the VAS or NRS-101
If scored using the ranking method, the scores do not necessarily have ratio qualities
People forced to choose one word, even if no word on the scale adequately describes their pain intensity
Visual Analogue Scale (VAS)
Easy to administer
Many (“infinite”) response categories
Scores can be treated as ratio data
Good evidence for construct validity
Extra step in scoring the paper-and-pencil version can take more time
Some people, especially older people, have difficulty using the VAS, make for an additional source of error
Numerical Rating Scale (NRS)
Easy to administer
Many response categories if NRS-101 chosen
Easy to score
Compliance with measurement task is high
Good evidence for construct validity
Suitable for telephone administration
Scores cannot necessarily be treated as ratio data

BOX 38-4 Single-Dimension Pain Scales

Visual Analog Scale

No pain → Worst pain imaginable

Numerical Rating Scale

0 1 2 3 4 5 6 7 8 9 10

No Pain → Worst pain imaginable

Verbal Rating Scale

None → Mild → Moderate → Severe

No pain → Mild → Discomforting → Distressing → Horrible → Excruciating

Table 38.7 McGill Pain Questionnaire

What Does Your Pain Feel Like?
Statement: Some of the following words below describe your present pain. Circle ONLY those words that best describe it. Leave out any category that is not suitable. Use only a single word in each appropriate category – the one that applies best.
Group Descriptor Points
1 (temporal) flickering 1
  quivering 2
  pulsing 3
  throbbing 4
  beating 5
  pounding 6
2 (spatial) jumping 1
  flashing 2
  shooting 3
3 (punctate pressure) pricking 1
  boring 2
  drilling 3
  stabbing 4
  lancinating 5
4 (incisive pressure) sharp 1
  cutting 2
  lacerating 3
5 (constrictive pressure) pinching 1
  pressing 2
  gnawing 3
  cramping 4
  crushing 5
6 (traction pressure) tugging 1
  pulling 2
  wrenching 3
7 (thermal) hot 1
  boring 2
  scalding 3
  searing 4
8 (brightness) tingling 1
  itchy 2
  smarting 3
  stinging 4
9 (dullness) dull 1
  sore 2
  hurting 3
  aching 4
  heavy 5
10 (sensory miscellaneous) tender 1
  taut 2
  rasping 3
  splitting 4
11 (tension) tiring 1
  exhausting 2
12 (autonomic) sickening 1
  suffocating 2
13 (fear) fearful 1
  frightful 2
  terrifying 3
14 (punishment) punishing 1
  grueling 2
  cruel 3
  vicious 4
  killing 5
15 (affective-evaluative- sensory: miscellaneous) wretchedblinding 12
16 (evaluative) annoying 1
  troublesome 2
  miserable 3
  intense 4
  unbearable 5
17 (sensory: miscellaneous) spreading 1
  radiating 2
  penetrating 3
  piercing 4
18 (sensory: miscellaneous) tight 1
  numb 2
  drawing 3
  squeezing 4
  tearing 5
19 (sensory) cool 1
  cold 2
  freezing 3
20 (affective-evaluative: miscellaneous) naggingnauseating 12
  agonizing 3
  dreadful 4
  torturing 5
Pain score = SUM (points for applicable descriptors)
How Does Your Pain Change with Time?
Question Response Points
Which word or words would you use to describe the pattern of your pain? continuous, steady, constantrhythmic, periodic, intermittent 12
  brief, momentary, transient 3
Do the following items increase or decrease your pain?
(1) liquor
(2) stimulants such as coffee
(3) eating
(4) heat
(5) cold
(6) damp
(7) weather changes
(8) massage or use of a vibrator
(9) pressure
(10) no movement
(11) movement
(12) sleep or rest
(13) lying down
(14) distraction (TV, reading, etc.)
(15) urination or defecation
(16) tension
(17) bright lights
(18) loud noises
(19) going to work
(20) intercourse
(21) mild exercise
(22) fatigue
How Strong is Your Pain?
Statement: People agree that the following 5 words (mild, discomforting, distressing, horrible, excruciating) represent pain of increasing intensity. To answer each question below write the number of the most appropriate word in the space beside the question.
Question Response Points
Which word describes your pain right now? mild 1
  discomforting 2
  distressing 3
  horrible 4
  excruciating 5
Which word describes it at its worst? mild 1
  discomforting 2
  distressing 3
  horrible 4
  excruciating 5
Which word describes it when it is least? mild 1
  discomforting 2
  distressing 3
  horrible 4
  excruciating 5
Which word describes the worst toothache you ever had? mild 1
  discomforting 2
  distressing 3
  horrible 4
  excruciating 5
Which word describes the worst headache you ever had? mild 1
  discomforting 2
  distressing 3
  horrible 4
  excruciating 5
Which word describes the worst stomach- ache you ever had? mild 1
  discomforting 2
  distressing 3
  horrible 4
  excruciating 5
Interpretation:    
image minimum pain score: 0 (would not be seen in a person with true pain)
image maximum pain score: 78
image The higher the pain score the greater the pain.

Adapted from Melzack R. The McGill pain questionnaire: major properties and scoring methods. Pain 1975;1:275–99.

Table 38.8 McGill Pain Questionnaire–Short Form

image

Work disability

The are five outstanding reasons for measuring work outcomes are as follows:

image To assess productivity loss in clinical trials
image To evaluate the effectiveness of health services
image To target injury and reinjury prevention programs
image To evaluate the effectiveness of work reorganization projects such as ergonomic changes
image To improve provider-worker and provider-safety engineer interaction

The five scales of WL-26 (work load 26) developed by the National Institute for Occupational Safety and Health are as follows:

image Work scheduling
image Physical demands
image Mental demands
image Social demands
image Output demands

BOX 38-5 Listing of WL-26 items

1. Getting to work on time.
2. Sticking to a routine or schedule without having to rearrange or reassign your work tasks.
3. Working without taking frequent rests or breaks to avoid discomfort.
4. Working the required number of hours.
5. Handling very demanding or stressful work situations.
6. Doing your work without becoming tense or frustrated.
7. Doing your work carefully.
8. Satisfying those people who judge your work.
9. Feeling a sense of accomplishment.
10. Finishing work on time.
11. Handling the workload.
12. Lifting, carrying, or moving objects at work weighing 10 pounds or less.
13. Lifting, carrying, or moving objects at work weighing more than 10 pounds.
14. Walking more than one block or climbing up or down one flight of stairs while working.
15. Sitting, standing, or staying in one position for longer than 15 minutes while working.
16. Bending, twisting, or reaching while working.
17. Using hand-operated tools or equipment (for example, pen, drill, sander, keyboard, or computer mouse).
18. Using your upper body to operate tools or equipment (upper body means arms, head, neck, shoulders, or upper back).
19. Using your lower body to operate tools or equipment (lower body means legs, knees, feet, or lower back).
20. Keeping your mind on your work.
21. Keeping track of more than one task or project at the same time.
22. Concentrating on your work.
23. Remembering things having to do with your work.
24. Talking with people in person, in meetings, or on the phone.
25. Controlling irritability or anger towards people when working.
26. Helping other people to get work done.

Patient satisfaction

Patient satisfaction is another important outcome scale because pain can be interpreted differently by different individuals. The scales most often used to measure patient satisfaction are given here.

image

Figure 38–1 Characteristics of patient satisfaction measures.

Table 38.9 Sample Items According to Content Characteristics

Global—Multidimensional
“In an overall, general sense, how satisfied are you with the service you received?” (CSQ)
“Doctors examine their patients carefully before deciding what is wrong.” (thoroughness) (PSQ)
“I can reach a doctor to ask him questions at any time.” (accessibility) (PSQ)
“I think my doctor forgets to ask about problems I’ve had in the past.” (follow-up) (PSQ)

Care—Treatment outcome
“All things considered, how satisfied are you with your treatment? (GPAS)
“How satisfied are you with the overall results of your back surgery?” (FOQ)
“Have the services you received helped you to deal more effectively with your problems?” (CSQ)
Generic— Disease-specific
“Have the services you received helped you to deal more effectively with your problems?” (CSQ)
“The doctor told me what to do to prevent future back problems.” (PSS)
Direct—Indirect “Doctors always try to explain about an operation so the patient won’t worry.” (PSQ)

PSS, Patient Satisfaction Scales [3]; PSQ, Patient Satisfaction Questionnaire [4]; CSQ, Client Satisfaction Questionnaire [5]; FOQ, Functional Outcomes Questionnaire [6]; GPAS, = General Practice Assessment Survey[7]. From Hudak PL, Wright JG. The characteristics of patient satisfaction measures. Spine 2000;25:3167-3177.

BOX 38-6 Patient Satisfaction Subscales

Questions Included in “Information” Subscale (3)

The physician gave me enough information about the cause of my back pain.

The physician did not give me a clear explanation of the cause of my pain.

The physician told me what to do to prevent future back problems.

Questions Included in “Caring” Subscale (4)

The physician seemed to believe that my pain was real.

The physician did not understand the concerns I had about my back problem.

The physician did not seem comfortable dealing with my back pain.

The physician was not concerned about what happened with my pain after I left the office.

Questions Included in “Effectiveness” Subscale (3)

The treatment the physician prescribed for my back was effective.

The physician seemed confident that the treatment she/he recommended would work.

The physician gave me a clear idea of how long it might take for my back to get better.

Questions Not Included in Any Subscale (7)

After seeing the physician I did not know what I needed to do for my back pain.

The physician did not listen carefully to my description of my back problem.

The physician made me feel less worried about my back problem.

The physician performed a thorough examination of my back.

The physician did not understand what was wrong with my back.

The physician should have ordered more tests or radiographs.

The physician should have referred me to a back specialist.

Response options: 1 = strongly agree; 2 = agree; 3 = neither agree nor disagree; 4 = disagree;, 5 = strongly disagree. For analysis, strongly favorable responses are recorded as “1” and strongly unfavorable responses are recorded as “5.” Note: Subscales are based on results of factor analyses.

References

1 Roland M.O., Morris R.W. A study of the natural history of back pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine. 1983;8:141-144.

2 Hupli M., Sainio P., Hurri H., et al. Comparison of trunk strength measurements between two different isokinetic devices used at clinical settings. J Spinal Disord. 1997;10:391-393.

3 Cherkin D., Deyo R.A., Berg A.O. Evaluation of a physician education intervention to improve primary care for low-back pain. II. Impact on patients. Spine (Phila Pa 1976). 1991;16(10):1173-1178.

4 Ware J.E.Jr, Snyder M.K., Wright W.R., Davies A.R. Defining and measuring patient satisfaction with medical care. Eval Program Plann. 1983;6(3–4):247-263.

5 Larsen D.L., Attkisson C.C., Hargreaves W.A., Nguyen T.D. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207.

6 Nork S.E., Hu S.S., Workman K.L., Glazer P.A., Bradford D.S. Patient outcomes after decompression and instrumented posterior spinal fusion for degenerative spondylolisthesis. Spine (Phila Pa 1976). 1999;24(6):561-569.

7 National Primary Care Research and Development Centre. General Practice Assessment Survey (GPAS) Manual. Manchester: University of Manchester, 1999.

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