ema methods to evaluate triggers of menopausal hot flashes rebecca c. thurston, phd university of...
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EMA Methods to Evaluate EMA Methods to Evaluate Triggers of Menopausal Triggers of Menopausal
Hot FlashesHot Flashes
Rebecca C. Thurston, PhDRebecca C. Thurston, PhDUniversity of Pittsburgh School of Medicine, University of Pittsburgh School of Medicine,
Department of PsychiatryDepartment of Psychiatry
BackgroundBackground
• Hot flashes experienced by most (70%) women during menopause
• Associated with impairments in quality of life, mood, sleep
• Etiology and triggers not well understood
• “Stress” leading reported trigger
BackgroundBackground
• Lack of rigorous research– Retrospective, one-time self-report
measures: emotions and hot flashes
– Irregular, mundane, frequent experiences
– Memory and reporting biases
• Need for prospective measurement
• Physiologic measures of hot flashes
Primary HypothesesPrimary Hypotheses
• Within individuals: Physiologic hot flashes more likely after
↑ Negative emotion↓ Positive emotion
• Between individuals: Women with more physiologic hot flashes
↑Negative psychological functioning
Secondary HypothesesSecondary Hypotheses
• Explore emotional antecedents of “false positive” hot flashes
–Reported hot flashes lacking physiological concomitant
Rationale for Use of EMA MethodsRationale for Use of EMA Methods
• Prospective reports:– Emotions– Hot flashes
• Avoid memory biases
• Physiologic measures of hot flashes
• Compare subjective/objective hot flashes
• Characterize naturally-occurring emotions and hot flashes in “real life” environment
Sample CharacteristicsSample Characteristics
• N = 42
• Perimenopausal or postmenopausal
• Age 40 to 60
• At least one hot flash a day
• Not taking medications known to impact hot flashes
OverviewOverview
Screening, Informed Consent
Day 1: Ambulatory Sternal Skin Conductance (SCL) Monitoring, Diary,
Sleep Sheet, Questionnaires Day 2: Ambulatory SCL Monitoring, Diary,
Sleep Sheet
Debrief
DiaryDiary
• Fixed time sampling (primary)
– 3 times/hour, waking hours
– Emotion report within 30 min before hot flash
• Event sampling (secondary):
– Entry at experience of hot flash
• Temporal frame: Current state
– Avoid any memory effects
Diary Assessment MethodDiary Assessment Method• Paper diary
– Low cost, minimal start up, minimal particiapant training, good for population?
• Prompting method– Watchminder Training and Reminder System
– Program to sleep schedule
– Sync time with hot flash monitor
• Compliance– Careful explanation, instruction page, practice entry
– Emphasize importance of completion time accuracy
Diary ContentDiary Content• Time• Location (home, work, car, other)• Activities (walking, eating, talking/listening, etc)• Occurrence and intensity of hot flash• Emotions
– Frustrated, sad, stressed– Tired – Relaxed, happy, in control
• Use of tobacco, caffeine, alcohol• Sleep Sheet
Biolog Hot Flash MonitorBiolog Hot Flash Monitor
• Sampling: continuous recording of sternal skin conductance (1 Hz)
– Subjective event markers: time/date stamp– Can’t get wet, no rigorous exercise
• Compliance – Careful instruction, instruction sheet, number to call with problems– Allow to take off in am to shower– Initially only one night
Skin Conductance Measured Hot Skin Conductance Measured Hot Flash with Event MarkFlash with Event Mark
Case Crossover DesignCase Crossover Design
Monitor Hookup 7:00-10:00 am
Sleep
Hazard Period
Flash
Day 1
Day 2
Monitor Unhook (upon
waking)
Control Period
Monitoring Period
(Maclure, 1991; Mittleman, 1993, 2001)
Data analysisData analysis
• Clustered data – nonindependence of observations
• Unequal monitoring time
• Generalized Estimating Equations
• Control for time of day
Physiologically Measured Hot Physiologically Measured Hot FlashesFlashes
0
0.2
0.4
0.6
0.8
10-
1
1-2
2-3
3-4
4-5
5-6
6-7
7-8
8-9
9-10
10-1
1
11-1
2
12-1
3
13-1
4
14-1
5
15-1
6
16-1
7
17-1
8
18-1
9
19-2
0
20-2
1
21-2
2
22-2
3
23-2
4
Hour
Ho
t fl
ash
es p
er s
ub
ject
day
Emotional Antecedents of Emotional Antecedents of PhysiologicPhysiologic Hot Flashes Hot Flashes
0
0.5
1
1.5
2O
R o
f Hot
Fla
sh
Fru
stration
Sad
ness
Stress
Tired
Hap
py
Relaxed
In
Con
trol
*
*
*
** *
* p < 0.05(Thurston et al., 2005, Psychosom Med)
Psychological Factors Associated Psychological Factors Associated with with PhysiologicPhysiologic Hot Flashes Hot Flashes
0
5
10
15
20
25
30
Low Medium High
Ph
ysio
logi
c H
ot F
lash
es (
n)
State Anxiety
Trait Anxiety
Negative Attitudes
* *** †
† p < 0.1* p < 0.05
(Thurston et al., 2005, Psychosom Med)
Reporting of Hot FlashesReporting of Hot Flashes ObjectiveObjective
SubjectiveSubjective
YesYes NoNo
YesYes 347347 208208
False False positivepositive
NoNo 394394 ----
(Thurston et al., 2005, Psychosom Med)
Emotional Antecedents of Emotional Antecedents of “False “False Positive”Positive” Hot Flashes Hot Flashes
0
0.5
1
1.5
2
OR
Fal
se P
osit
ive
Hot
Fla
sh
Fru
stration
Sad
ness
Stress
Tired
Hap
py
Relaxed
In
Con
trol
*
*
* p < 0.05(Thurston et al., 2005, Psychosom Med)
Psychological Factors Associated with Psychological Factors Associated with “False Positive”“False Positive” Hot Flashes Hot Flashes
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
low medium high
Fal
se p
osit
ive
repo
rtin
g ra
te
DepressionState anxietyTrait anxietyNegative attitudesSomatization
**
**
*† †*
†
† p < 0.1* p < 0.05
(Thurston et al., 2005, Psychosom Med)
ConclusionsConclusions
↑ Positive Emotion/Traits
↑ Physiologic Hot Flashes
↑ Negative Emotions/Traits
↑ “False positive” hot flashes
Between and within subjects
Lessons LearnedLessons Learned• Paper diaries convenient, but
understanding compliance an issue– New study using electronic diaries:
date/time stamp
– Expanded questions about hot flashes
– Beeper imbedded within palm
– Reminder beep if miss entry (5 minute)
– Instruct that we know when they fill out
– Electronic diaries tolerated well
Lessons LearnedLessons Learned
• Nice to take off monitor in am, but better to have 24 hours of data– Capture circadian rhythm more accurately
– Normalize monitor durations
– Careful recording of start/stop times
– Ideally: More days of monitoring due to variability in hot flashes between days
– Monitor tolerated well during sleep
Instructions, instructionsInstructions, instructions
• Participant training/orientation critical to getting good data
• Practice diary entry/use of monitor
• Interim phone calls
• Documentation to take home
• Way to get in touch with study staff
Acknowledgements
James Blumenthal, PhD
Andrew Sherwood, PhD
Michael Babyak, PhD
Janet Carpenter, PhD
Behavioral Antecedents of Hot FlashesBehavioral Antecedents of Hot Flashes
0
1
2
3
4
5
OR
of H
ot F
lash
Physical Exertion
Physical Effort
Caffeine Use†
** p < 0.01* p = 0.05
**
**
*
†prior to and during
Adjusted for time of day
Emotions During and Emotions During and Following Hot FlashesFollowing Hot Flashes
• During hot flashes: no significant differences from control
• Following hot flashes: no significant differences from control
Don’t forget about nighttime!Don’t forget about nighttime!• Women tolerate overnight monitoring well
• Sleep an issue in women with hot flashes
• Physiologic hot flash measures important during sleep
• Now more complete sleep data:– More extensive sleep diary– Better questionnaire measures– Actigraphy
Reported Sleep Problems andReported Sleep Problems and Physiologic Hot Flashes Physiologic Hot Flashes
during Sleepduring Sleep
(Thurston et al., 2006, Int J Behav Med)
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
Dairy wakening Diary times outof bed
Sleep Problems
Rat
e R
atio
(R
R)
Ph
ysio
logi
c H
ot F
lash
es
SWEL sleep problems
Reported Sleep Problems and Reported Sleep Problems and Reported Hot Flashes during Reported Hot Flashes during
SleepSleep
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
SWEL sleepproblems
Diary wakenings Diary times outof bed
Sleep Problems
RR
Rep
orte
d H
ot F
lash
es
**
*
†
† p = 0.10* p < 0.05** p < 0.001(Thurston et al., 2006, Int J Behav Med)