EMA Methods to Evaluate Triggers of Menopausal Hot Flashes

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EMA Methods to Evaluate Triggers of Menopausal Hot Flashes. Rebecca C. Thurston, PhD University of Pittsburgh School of Medicine, Department of Psychiatry. Background. Hot flashes experienced by most (70%) women during menopause Associated with impairments in quality of life, mood, sleep
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EMA Methods to Evaluate Triggers of Menopausal Hot Flashes Rebecca C. Thurston, PhD University of Pittsburgh School of Medicine, Department of Psychiatry Background
  • 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
  • Background
  • 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 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 Hypotheses
  • Explore emotional antecedents of “false positive” hot flashes
  • Reported hot flashes lacking physiological concomitant
  • Rationale 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 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
  • Overview Screening, Informed Consent Day 1: Ambulatory Sternal Skin Conductance (SCL) Monitoring, Diary, Sleep Sheet, Questionnaires Day 2: Ambulatory SCL Monitoring, Diary, Sleep Sheet Debrief Diary
  • 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 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 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 monitor Biolog 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 Flash with Event Mark Case Crossover Design Monitor Unhook (upon waking) Monitor Hookup 7:00-10:00 am Sleep Day 1 Day 2 Monitoring Period Control Period Hazard Period Flash (Maclure, 1991; Mittleman, 1993, 2001) Data analysis
  • Clustered data – nonindependence of observations
  • Unequal monitoring time
  • Generalized Estimating Equations
  • Control for time of day
  • Physiologically Measured Hot Flashes Emotional Antecedents of Physiologic Hot Flashes * * * * * * * p < 0.05 In Control Frustration Sadness Stress Tired Happy Relaxed (Thurston et al., 2005, Psychosom Med) * † * * * † p < 0.1 * p < 0.05 Psychological Factors Associated with Physiologic Hot Flashes (Thurston et al., 2005, Psychosom Med) Reporting of Hot Flashes (Thurston et al., 2005, Psychosom Med) Emotional Antecedents of “False Positive” Hot Flashes * * * p < 0.05 (Thurston et al., 2005, Psychosom Med) Frustration In Control Sadness Stress Tired Happy Relaxed Psychological Factors Associated with “False Positive” Hot Flashes † † * † * * * * * † p < 0.1 * p < 0.05 (Thurston et al., 2005, Psychosom Med) Conclusions
  • Positive Emotion/Traits
  • Physiologic Hot Flashes
  • Negative Emotions/Traits
  • “False positive” hot flashes
  • Between and within subjects
  • Lessons 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 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, 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 Physical Exertion Physical Effort Caffeine Use† Behavioral Antecedents of Hot Flashes ** * ** ** p < 0.01 * p = 0.05 †prior to and during Adjusted for time of day Emotions During and Following Hot Flashes
  • During hot flashes: no significant differences from control
  • Following hot flashes: no significant differences from control
  • 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 and Physiologic Hot Flashes during Sleep SWEL sleep problems (Thurston et al., 2006, Int J Behav Med) ** * † † p = 0.10 * p < 0.05 ** p < 0.001 (Thurston et al., 2006, Int J Behav Med) Reported Sleep Problems and Reported Hot Flashes during Sleep
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