Download Results - immpact

Pain Reporting: Patient
Training, Compliance, and
Monitoring
Mark P. Jensen, Ph.D.
University of Washington, Seattle, WA USA
IMMPACT-XVIII
June 4-5, Washington DC
Overview
Overview
- The problem
Overview
- The problem
- Increasing accuracy by…
Overview
- The problem
- Increasing accuracy by…
 Patient training
Overview
- The problem
- Increasing accuracy by…
 Patient training
 Compliance Monitoring
Overview
- The problem
- Increasing accuracy by…
 Patient training
 Compliance Monitoring
- Future directions
The Problem
Patients are not consistent
Study participants do not always
comply with procedures
We do not know the impact of this
inconsistency and noncompliance
Subjects are not consistent
Williams et al. (2000). Simple pain rating scales hide complex idiosyncratic meanings. Pain,
85, 457-463.
N = 78 patients with mixed chronic pain
How bad is your pain?
No pain
Maximum
pain
Rate how bad your pain is on a 0 (No pain) to
10 (Maximum pain) scale
Subjects are not consistent
Those with multiple pains sometimes
(but not necessarily always):
Williams et al., 2000
Subjects are not consistent
Those with multiple pains sometimes
(but not necessarily always):
- Rated main pain only: 69%
Williams et al., 2000
Subjects are not consistent
Those with multiple pains sometimes
(but not necessarily always):
- Rated main pain only: 69%
- Rated whichever pain was worst at
the time: 69%
Williams et al., 2000
Subjects are not consistent
Those with multiple pains sometimes
(but not necessarily always):
- Rated main pain only: 69%
- Rated whichever pain was worst at
the time: 69%
- Combined the pains: 64%
Williams et al., 2000
Subjects are not consistent
Pain intensity or pain distress?:
Williams et al., 2000
Subjects are not consistent
Pain intensity or pain distress?:
- Think of each separately: 45%
Williams et al., 2000
Subjects are not consistent
Pain intensity or pain distress?:
- Think of each separately: 45%
- Not distinguish between the two:
39%
Williams et al., 2000
Subjects are not consistent
Pain intensity or pain distress?:
- Think of each separately: 45%
- Not distinguish between the two:
39%
- Unable to distinguish(“One big
hurt”): 56%
Williams et al., 2000
Subjects are not consistent
Factors that impact ratings of current
pain:
- 14 of them
- Factors inconsistent between and
within patients
Williams et al., 2000
Subjects are not consistent
Factor
Pain impact
Always/Often Sometimes Rarely/Never
47
24
7
Williams et al., 2000
Subjects are not consistent
Factor
Always/Often Sometimes Rarely/Never
Pain impact
47
24
7
Tiredness
36
16
26
Williams et al., 2000
Subjects are not consistent
Factor
Always/Often Sometimes Rarely/Never
Pain impact
47
24
7
Tiredness
36
16
26
Overall mood
16
31
31
Williams et al., 2000
Subjects are not consistent
Broderick et al. (2006). Recalled pain ratings: A complext and poorly defined task. Journal of
Pain, 7, 142-149.
N = 96 patient seen in a rheumatology practice
Severity of your pain in the last week?
No pain
Worst
possible
pain
Interviewed patients re: strategies used
Subjects are not consistent
No
Not
sure
Factor
Yes
Used info from entire week
69% 20% 12%
Broderick et al., 2000
Subjects are not consistent
No
Not
sure
Factor
Yes
Used info from entire week
Generated an average
69% 20% 12%
52% 40% 8%
Broderick et al., 2000
Subjects are not consistent
No
Not
sure
Factor
Yes
Used info from entire week
Generated an average
Considered flares
69% 20% 12%
52% 40% 8%
37% 35% 14%
Broderick et al., 2000
Subjects are not consistent
No
Not
sure
Factor
Yes
Used info from entire week
Generated an average
Considered flares
Considered times w/o pain
69% 20% 12%
52% 40% 8%
37% 35% 14%
32% 28% 2%
Broderick et al., 2000
Subjects are not consistent
No
Not
sure
Factor
Yes
Used info from entire week
Generated an average
Considered flares
Considered times w/o pain
Focused on certain days
69% 20% 12%
52% 40% 8%
37% 35% 14%
32% 28% 2%
35% 63% 2%
Broderick et al., 2000
Subjects are not consistent
No
Not
sure
Factor
Yes
Used info from entire week
Generated an average
Considered flares
Considered times w/o pain
Focused on certain days
Considered impact
69% 20% 12%
52% 40% 8%
37% 35% 4%
32% 28% 2%
35% 63% 2%
98% 2% 0%
Broderick et al., 2000
Subjects are not consistent
We do not know the
impact of this
inconsistency
Subjects are not consistent
To have pain is to have
certainty;
~ Elaine Scarry, 1985
Subjects are not consistent
To have pain is to have
certainty;
to hear about pain is to
have doubt
~ Elaine Scarry, 1985
Solution 1: Training?
Dworkin et al. (in press). Reliability is necessary but far from sufficient: How might the
validity of pain ratings be improved? Clinical Journal of Pain.
The PROTECCT working group of AAACTTION
(part of the department of ACCRONYM):
Solution 1: Training?
Dworkin et al. (in press). Reliability is necessary but far from sufficient: How might the
validity of pain ratings be improved? Clinical Journal of Pain.
The PROTECCT working group of AAACTTION
(part of the department of ACCRONYM):
1. Personal anchors for “mild” and “worst” pain.
Solution 1: Training?
Dworkin et al. (in press). Reliability is necessary but far from sufficient: How might the
validity of pain ratings be improved? Clinical Journal of Pain.
The PROTECCT working group of AAACTTION
(part of the department of ACCRONYM):
1. Personal anchors for “mild” and “worst” pain.
2. Education re: “average” pain.
Solution 1: Training?
Dworkin et al. (in press). Reliability is necessary but far from sufficient: How might the
validity of pain ratings be improved? Clinical Journal of Pain.
The PROTECCT working group of AAACTTION
(part of the department of ACCRONYM):
1. Personal anchors for “mild” and “worst” pain.
2. Education re: “average” pain.
3. Rate painful condition only.
.
Solution 1: Training?
Dworkin et al. (in press). Reliability is necessary but far from sufficient: How might the
validity of pain ratings be improved? Clinical Journal of Pain.
The PROTECCT working group of AAACTTION
(part of the department of ACCRONYM):
1. Personal anchors for “mild” and “worst” pain.
2. Education re: “average” pain.
3. Rate painful condition only.
4. Distinct from mood, fatigue, impact.
Solution 1: Training?
Dworkin et al. (in press). Reliability is necessary but far from sufficient: How might the
validity of pain ratings be improved? Clinical Journal of Pain.
The PROTECCT working group of AAACTTION
(part of the department of ACCRONYM):
1. Personal anchors for “mild” and “worst” pain.
2. Education re: “average” pain.
3. Rate painful condition only.
4. Distinct from mood, fatigue, impact.
5. Elicit cooperation as research partners.
Solution 1: Training?
Analgesic Solutions (2015). Reporting your pain: What should I know before my clinical
study?
1. Elicit cooperation as research partner.
Solution 1: Training?
Analgesic Solutions (2015). Reporting your pain: What should I know before my clinical
study?
1. Elicit cooperation as research partner.
2. Introduce 0-10 scale.
Solution 1: Training?
Analgesic Solutions (2015). Reporting your pain: What should I know before my clinical
study?
1. Elicit cooperation as research partner.
2. Introduce 0-10 scale.
3. Identify personal experience associated with
different ratings (3,6,9).
Solution 1: Training?
Analgesic Solutions (2015). Reporting your pain: What should I know before my clinical
study?
1. Elicit cooperation as research partner.
2. Introduce 0-10 scale.
3. Identify personal experience associated with
different ratings (3,6,9).
4. Specify that “0” pain and awake times only should
be included for average pain ratings.
Solution 1: Training?
Analgesic Solutions (2015). Reporting your pain: What should I know before my clinical
study?
1. Elicit cooperation as research partner.
2. Introduce 0-10 scale.
3. Identify personal experience associated with
different ratings (3,6,9).
4. Specify that “0” pain and awake times only should
be included for average pain ratings.
5. Emphasize importance of accuracy, consistency,
possibility of change, and specificity.
Solution 1: Training?
Analgesic Solutions (2015). Reporting your pain: What should I know before my clinical
study?
1. Elicit cooperation as research partner.
2. Introduce 0-10 scale.
3. Identify personal experience associated with
different ratings (3,6,9).
4. Specify that “0” pain and awake times only should
be included for average pain ratings.
5. Emphasize importance of accuracy, consistency,
possibility of change, and specificity.
6. Provides five examples
Unresolved issues
Unresolved issues
We do not know if training has any benefits on
reliability and validity (research is under way).
Unresolved issues
We do not know if training has any benefits on
reliability and validity (research is under way).
Inconsistency may be trait and not state factor; maybe
we need to screen for accuracy instead.
Unresolved issues
We do not know if training has any benefits on
reliability and validity (research is under way).
Inconsistency may be trait and not state factor; maybe
we need to screen for accuracy instead.
Training may not get at the key issues:
- Only two programs, without 100% overlap
Unresolved issues
We do not know if training has any benefits on
reliability and validity (research is under way).
Inconsistency may be trait and not state factor; maybe
we need to screen for accuracy instead.
Training may not get at the key issues:
- Only two programs, without 100% overlap
Training has a cost; is the cost worth the benefit(s)?
Unresolved issues
We do not know if training has any benefits on
reliability and validity (research is under way).
Inconsistency may be trait and not state factor; maybe
we need to screen for accuracy instead.
Training may not get at the key issues:
- Only two programs, without 100% overlap
Training has a cost; is the cost worth the benefit(s)?
Strategies other than training may improve reliability
and validity (e.g., assess something that might be
easier to recall – worst pain?).
Solution 2: Monitoring?
Scoping review of monitoring
strategies
Solution 2: Monitoring?
Scoping review of monitoring
strategies
Performed on May 7, 2015
Solution 2: Monitoring?
Scoping review of monitoring
strategies
Performed on May 7, 2015
Search terms in title or abstract =
“pain”, “assessment monitoring”
Solution 2: Monitoring?
Scoping review of monitoring
strategies
Performed on May 7, 2015
Search terms in title or abstract =
“pain”, “assessment monitoring”
Publication type = clinical trial
Solution 2: Monitoring?
Results
Solution 2: Monitoring?
Results
0 Studies.
Solution 2: Monitoring?
Results
0 Studies.
Conclusions
What we know about monitoring:
Solution 2: Monitoring?
Results
0 Studies.
Conclusions
What we know about monitoring:
zilch,
Solution 2: Monitoring?
Results
0 Studies.
Conclusions
What we know about monitoring:
zilch, bupkas,
Solution 2: Monitoring?
Results
0 Studies.
Conclusions
What we know about monitoring:
zilch, bupkas, zip,
Solution 2: Monitoring?
Results
0 Studies.
Conclusions
What we know about monitoring:
zilch, bupkas, zip, diddly-squat,
Solution 2: Monitoring?
Results
0 Studies.
Conclusions
What we know about monitoring:
zilch, bupkas, zip, diddly-squat,
nichts,
Solution 2: Monitoring?
Results
0 Studies.
Conclusions
What we know about monitoring:
zilch, bupkas, zip, diddly-squat,
nichts, nada,
Solution 2: Monitoring?
Results
0 Studies.
Conclusions
What we know about monitoring:
zilch, bupkas, zip, diddly-squat,
nichts, nada, naught,
Solution 2: Monitoring?
Results
0 Studies.
Conclusions
What we know about monitoring:
zilch, bupkas, zip, diddly-squat,
nichts, nada, naught, nothing,
Solution 2: Monitoring?
Results
0 Studies.
Conclusions
What we know about monitoring:
zilch, bupkas, zip, diddly-squat,
nichts, nada, naught, nothing,
zero,
Solution 2: Monitoring?
Results
0 Studies.
Conclusions
What we know about monitoring:
zilch, bupkas, zip, diddly-squat,
nichts, nada, naught, nothing,
zero, not a bit,
Solution 2: Monitoring?
Results
0 Studies.
Conclusions
What we know about monitoring:
zilch, bupkas, zip, diddly-squat,
nichts, nada, naught, nothing,
zero, not a bit, and nil.
What might monitoring look like?
What might monitoring look like?
Ensure ratings are provided at the
correct times
What might monitoring look like?
Ensure ratings are provided at the
correct times
- Paper and pencil diaries?
What might monitoring look like?
Ensure ratings are provided at the
correct times
- Paper and pencil diaries?
- Paging, Interactive Voice
Response assessment, phone
interviews, clinic visits, other?
What might monitoring look like?
Ensure that ratings are consistent
with instructions/expected
behavior:
What might monitoring look like?
Ensure that ratings are consistent
with instructions/expected
behavior:
Least < Average < Worst
What might monitoring look like?
Ensure that ratings are consistent
with instructions/expected
behavior:
Least < Average < Worst
At least some variability,
What might monitoring look like?
Ensure that ratings are consistent
with instructions/expected
behavior:
Least < Average < Worst
At least some variability, but
maybe not too much?
What might monitoring look like?
Ensure that ratings are consistent
with instructions/expected
behavior:
Least < Average < Worst
At least some variability, but
maybe not too much?
Other?
Variability in ratings and validity
Harris et al. (2005). Characterization and consequences of pain variability in individuals with
fibromyalgia. Arthritis & Rheumatism, 52, 3670-3674.
N = 125 patients with fibromyalgia
Variability in ratings and validity
Harris et al. (2005). Characterization and consequences of pain variability in individuals with
fibromyalgia. Arthritis & Rheumatism, 52, 3670-3674.
N = 125 patients with fibromyalgia
RCT comparing placebo with milnacipran
Variability in ratings and validity
Harris et al. (2005). Characterization and consequences of pain variability in individuals with
fibromyalgia. Arthritis & Rheumatism, 52, 3670-3674.
N = 125 patients with fibromyalgia
RCT comparing placebo with milnacipran
4 times/day rating of current pain intensity for
15 days at baseline
Variability in ratings and validity
Harris et al. (2005). Characterization and consequences of pain variability in individuals with
fibromyalgia. Arthritis & Rheumatism, 52, 3670-3674.
N = 125 patients with fibromyalgia
RCT comparing placebo with milnacipran
4 times/day rating of current pain intensity for
15 days at baseline
What is the stability of pain variability?
Variability in ratings and validity
Harris et al. (2005). Characterization and consequences of pain variability in individuals with
fibromyalgia. Arthritis & Rheumatism, 52, 3670-3674.
N = 125 patients with fibromyalgia
RCT comparing placebo with milnacipran
4 times/day rating of current pain intensity for
15 days at baseline
What is the stability of pain variability?
What is the association between baseline
variability and treatment response?
Variability in ratings and validity
Variability is relative stable – r =
0.66 (appears to be trait like)
Harris et al., 2005
Variability in ratings and validity
Variability is relative stable – r =
0.66 (appears to be trait like)
Variability is associated with
response to placebo (r = 0.46)
but not active treatment (r =
0.09).
Harris et al., 2005
Variability in ratings and validity
Farrar et al. (2014). Effect of variability in the 7-day baseline pain diary on the assay sensitivity
of neuropathic pain randomized clinical trials: An ACTTION study. PAIN, 155, 16221631.
N = 12 clinical trials of gabapentin or
pregabalin (>2700 pts with PHN and DPN)
Variability in ratings and validity
Farrar et al. (2014). Effect of variability in the 7-day baseline pain diary on the assay sensitivity
of neuropathic pain randomized clinical trials: An ACTTION study. PAIN, 155, 16221631.
N = 12 clinical trials of gabapentin or
pregabalin (>2700 pts with PHN and DPN)
Data from RCTs comparing placebo with active
treatment
Variability in ratings and validity
Farrar et al. (2014). Effect of variability in the 7-day baseline pain diary on the assay sensitivity
of neuropathic pain randomized clinical trials: An ACTTION study. PAIN, 155, 16221631.
N = 12 clinical trials of gabapentin or
pregabalin (>2700 pts with PHN and DPN)
Data from RCTs comparing placebo with active
treatment
7 days of pain intensity ratings at baseline
Variability in ratings and validity
Farrar et al. (2014). Effect of variability in the 7-day baseline pain diary on the assay sensitivity
of neuropathic pain randomized clinical trials: An ACTTION study. PAIN, 155, 16221631.
N = 12 clinical trials of gabapentin or
pregabalin (>2700 pts with PHN and DPN)
Data from RCTs comparing placebo with active
treatment
7 days of pain intensity ratings at baseline
Does baseline variability (or other baseline
variables) predict and treatment response?
Variability in ratings and validity
Farrar et al., 2013
Variability in ratings and validity
Variability is associated with more
with response to placebo than active
treatment.
Farrar et al., 2013
Variability in ratings and validity
Variability is associated with more
with response to placebo than active
treatment.
Effects stronger for PHN than DPN
Farrar et al., 2013
Variability in ratings and validity
Variability is associated with more
with response to placebo than active
treatment.
Effects stronger for PHN than DPN
Small (perhaps not meaningful) effects
of age in PHN and weight in DPN
Farrar et al., 2013
Future directions
What we know
Future directions
What we know vs. What we don’t know
Future directions
What we know vs. What we don’t know
Future directions
Future directions
What patterns of inconsistency are most closely
associated with lack of assay sensitivity?
Future directions
What patterns of inconsistency are most closely
associated with lack of assay sensitivity?
Which patterns are modifiable (state) and which are not
(trait)?
Future directions
What patterns of inconsistency are most closely
associated with lack of assay sensitivity?
Which patterns are modifiable (state) and which are not
(trait)?
What training program(s) are mot effective @ changing
modifiable factors?
Future directions
What patterns of inconsistency are most closely
associated with lack of assay sensitivity?
Which patterns are modifiable (state) and which are not
(trait)?
What training program(s) are mot effective @ changing
modifiable factors?
What is the effect of training on validity?
Future directions
What patterns of inconsistency are most closely
associated with lack of assay sensitivity?
Which patterns are modifiable (state) and which are not
(trait)?
What training program(s) are mot effective @ changing
modifiable factors?
What is the effect of training on validity?
Are some domains easier to rate than others (e.g., worst
pain?) or are some people more reliable (e.g., less
variability) – maybe training is not needed?
Future directions
What patterns of inconsistency are most closely
associated with lack of assay sensitivity?
Which patterns are modifiable (state) and which are not
(trait)?
What training program(s) are mot effective @ changing
modifiable factors?
What is the effect of training on validity?
Are some domains easier to rate than others (e.g., worst
pain?) or are some people more reliable (e.g., less
variability) – maybe training is not needed?
Other important research questions?
In the meantime…
In the meantime…
Should or should we not be using
training/monitoring in studies at
this stage?
In the meantime…
Should or should we not be using
training/monitoring in studies at
this stage?
If so, what form(s) of training and
monitoring?
In the meantime…
Should or should we not be using
training/monitoring in studies at
this stage?
If so, what form(s) of training and
monitoring?
Can/should we select for accuracy
and consistency?
Thank You!