Symptom clusters among MsFLASH clinical trial participants

Nancy Fugate Woods; Chancellor Hohensee; Janet S. Carpenter; Lee Cohen; Kristine Ensrud; Ellen W. Freeman; Katherine A. Guthrie; Hadine Joffe; Andrea Z. Lacroix; Julie L. Otte

doi:10.1097/GME.0000000000000516

Symptom clusters among MsFLASH clinical trial participants

Nancy Fugate Woods, Chancellor Hohensee, Janet S. Carpenter, Lee Cohen, Kristine Ensrud, Ellen W. Freeman, Katherine A. Guthrie, Hadine Joffe, Andrea Z. Lacroix, Julie L. Otte

Medicine - Veteran's Administration Medical Center

Research output: Contribution to journal › Article › peer-review

27 Scopus citations

Abstract

Objective: Our objective was to identify symptom clusters using standardized measures completed by participants in the Menopausal Strategies: Finding Lasting Answers to Symptoms and Health clinical trial at baseline, including hot flash interference, and sleep, depressive, anxiety, and pain symptoms. Methods: Data from all women randomized to interventions and controls from Menopausal Strategies: Finding Lasting Answers to Symptoms and Health studies 1, 2, and 3 (N=899) were included; 797 with complete data were used in the analyses. Scores from standardized measures obtained at baseline included the following: Hot Flash-Related Daily Interference Scale, Insomnia Severity Index, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9 measure of depressed mood, Generalized Anxiety Disorder, and Brief Pain Inventory PEG scores (pain intensity [P], interference with enjoyment of life [E], and interference with daily activity [G]). Latent class analysis was used to identify symptom clusters using standardized scale scores and their established cut points. Results: We identified five classes using the Bayesian Information Criterion and the Akaike Information Criterion. Women in classes 1 and 2 had high hot flash interference levels relative to the others, and class 1 (10.5% of total) included severe hot flash interference, severe sleep symptoms, and moderately severe pain symptoms (hot flash, sleep, pain). In class 2 (14.1%), severe hot flash interference was paired with the severe sleep symptoms, and moderate to severe depressed and anxious mood symptoms and pain (hot flash, sleep, mood, pain). In class 3 (39.6%), women reported moderately severe sleep symptoms with moderate hot flash interference, and low severity mood and pain symptoms (hot flash, sleep). Those in class 4 (7.0%) reported moderate hot flash interference with severe levels of anxiety and depressed mood symptoms, but low levels of other symptoms (hot flash, mood). Women in class 5 (28.7%) reported the lowest levels of all the five symptoms (low severity symptoms). Conclusions: Women meeting hot flash frequency criteria for inclusion in clinical trials exhibited multiple co-occurring symptoms that clustered into identifiable groups according to symptom interference and severity. Variability of symptom profiles between the classes was evident, indicating that the classes were composed of differing symptom types and not simply differing severity levels. These symptom clusters may be useful phenotypes for differentiating treatment effects or evaluating associations with biomarkers or genes.

Original language	English (US)
Pages (from-to)	158-165
Number of pages	8
Journal	Menopause
Volume	23
Issue number	2
DOIs	https://doi.org/10.1097/GME.0000000000000516
State	Published - Feb 1 2016

Bibliographical note

Funding Information:
This study was funded by the National Institutes of Health as a cooperative agreement issued by the National Institute on Aging (NIA), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Center for Complementary and Alternative Medicine (NCCAM), the Office of Research on Women''s Health (ORWH), and grants U01 AG032656, U01AG032659, U01AG032669, U01AG032682, U01AG032699, U01AG032700 from the NIA. At Indiana University, the project was funded in part with support from the Indiana Clinical and Translational Sciences Institute, grant UL1RR02571 from the NIH, National Center for Research Resources, Clinical and Translational Sciences Award. L.C. has been a consultant for Noven Pharmaceutical, and has received research support from: Astra-Zeneca Pharmaceuticals; Bristol-Myers Squibb; Cephalon, Inc; GlaxoS-mithKline; Ortho-McNeil Janssen; Pfizer Inc and Sunovion Pharmaceut-icals, Inc. E.W.F. received research support from Forest Laboratories, Inc, Bionovo, Inc, and Xanodyne Pharmaceuticals, Inc. H.J. has received grant support from Cephalon/Teva, serves as a consultant to Merck, and on an advisory board for Noven and Merck. K.E. is a consultant on a Data Monitoring Committee for Merck, Sharp & Dohme. All other authors have no direct conflicts of interest or financial disclosures relevant to this manuscript.

Publisher Copyright:
© 2015 by The North American Menopause Society.

Keywords

Hot flashes
Menopause
Mood
Pain
Sleep disturbances
Symptom clusters

Publisher link

10.1097/GME.0000000000000516

http://europepmc.org/articles/pmc4731298

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@article{53869f8a70c3456983e3eec098e6e6d3,

title = "Symptom clusters among MsFLASH clinical trial participants",

abstract = "Objective: Our objective was to identify symptom clusters using standardized measures completed by participants in the Menopausal Strategies: Finding Lasting Answers to Symptoms and Health clinical trial at baseline, including hot flash interference, and sleep, depressive, anxiety, and pain symptoms. Methods: Data from all women randomized to interventions and controls from Menopausal Strategies: Finding Lasting Answers to Symptoms and Health studies 1, 2, and 3 (N=899) were included; 797 with complete data were used in the analyses. Scores from standardized measures obtained at baseline included the following: Hot Flash-Related Daily Interference Scale, Insomnia Severity Index, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9 measure of depressed mood, Generalized Anxiety Disorder, and Brief Pain Inventory PEG scores (pain intensity [P], interference with enjoyment of life [E], and interference with daily activity [G]). Latent class analysis was used to identify symptom clusters using standardized scale scores and their established cut points. Results: We identified five classes using the Bayesian Information Criterion and the Akaike Information Criterion. Women in classes 1 and 2 had high hot flash interference levels relative to the others, and class 1 (10.5% of total) included severe hot flash interference, severe sleep symptoms, and moderately severe pain symptoms (hot flash, sleep, pain). In class 2 (14.1%), severe hot flash interference was paired with the severe sleep symptoms, and moderate to severe depressed and anxious mood symptoms and pain (hot flash, sleep, mood, pain). In class 3 (39.6%), women reported moderately severe sleep symptoms with moderate hot flash interference, and low severity mood and pain symptoms (hot flash, sleep). Those in class 4 (7.0%) reported moderate hot flash interference with severe levels of anxiety and depressed mood symptoms, but low levels of other symptoms (hot flash, mood). Women in class 5 (28.7%) reported the lowest levels of all the five symptoms (low severity symptoms). Conclusions: Women meeting hot flash frequency criteria for inclusion in clinical trials exhibited multiple co-occurring symptoms that clustered into identifiable groups according to symptom interference and severity. Variability of symptom profiles between the classes was evident, indicating that the classes were composed of differing symptom types and not simply differing severity levels. These symptom clusters may be useful phenotypes for differentiating treatment effects or evaluating associations with biomarkers or genes.",

keywords = "Hot flashes, Menopause, Mood, Pain, Sleep disturbances, Symptom clusters",

author = "Woods, {Nancy Fugate} and Chancellor Hohensee and Carpenter, {Janet S.} and Lee Cohen and Kristine Ensrud and Freeman, {Ellen W.} and Guthrie, {Katherine A.} and Hadine Joffe and Lacroix, {Andrea Z.} and Otte, {Julie L.}",

note = "Funding Information: This study was funded by the National Institutes of Health as a cooperative agreement issued by the National Institute on Aging (NIA), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Center for Complementary and Alternative Medicine (NCCAM), the Office of Research on Women''s Health (ORWH), and grants U01 AG032656, U01AG032659, U01AG032669, U01AG032682, U01AG032699, U01AG032700 from the NIA. At Indiana University, the project was funded in part with support from the Indiana Clinical and Translational Sciences Institute, grant UL1RR02571 from the NIH, National Center for Research Resources, Clinical and Translational Sciences Award. L.C. has been a consultant for Noven Pharmaceutical, and has received research support from: Astra-Zeneca Pharmaceuticals; Bristol-Myers Squibb; Cephalon, Inc; GlaxoS-mithKline; Ortho-McNeil Janssen; Pfizer Inc and Sunovion Pharmaceut-icals, Inc. E.W.F. received research support from Forest Laboratories, Inc, Bionovo, Inc, and Xanodyne Pharmaceuticals, Inc. H.J. has received grant support from Cephalon/Teva, serves as a consultant to Merck, and on an advisory board for Noven and Merck. K.E. is a consultant on a Data Monitoring Committee for Merck, Sharp & Dohme. All other authors have no direct conflicts of interest or financial disclosures relevant to this manuscript. Publisher Copyright: {\textcopyright} 2015 by The North American Menopause Society.",

year = "2016",

month = feb,

day = "1",

doi = "10.1097/GME.0000000000000516",

language = "English (US)",

volume = "23",

pages = "158--165",

journal = "Menopause",

issn = "1072-3714",

publisher = "Lippincott Williams and Wilkins",

number = "2",

}

TY - JOUR

T1 - Symptom clusters among MsFLASH clinical trial participants

AU - Woods, Nancy Fugate

AU - Hohensee, Chancellor

AU - Carpenter, Janet S.

AU - Cohen, Lee

AU - Ensrud, Kristine

AU - Freeman, Ellen W.

AU - Guthrie, Katherine A.

AU - Joffe, Hadine

AU - Lacroix, Andrea Z.

AU - Otte, Julie L.

N1 - Funding Information: This study was funded by the National Institutes of Health as a cooperative agreement issued by the National Institute on Aging (NIA), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Center for Complementary and Alternative Medicine (NCCAM), the Office of Research on Women''s Health (ORWH), and grants U01 AG032656, U01AG032659, U01AG032669, U01AG032682, U01AG032699, U01AG032700 from the NIA. At Indiana University, the project was funded in part with support from the Indiana Clinical and Translational Sciences Institute, grant UL1RR02571 from the NIH, National Center for Research Resources, Clinical and Translational Sciences Award. L.C. has been a consultant for Noven Pharmaceutical, and has received research support from: Astra-Zeneca Pharmaceuticals; Bristol-Myers Squibb; Cephalon, Inc; GlaxoS-mithKline; Ortho-McNeil Janssen; Pfizer Inc and Sunovion Pharmaceut-icals, Inc. E.W.F. received research support from Forest Laboratories, Inc, Bionovo, Inc, and Xanodyne Pharmaceuticals, Inc. H.J. has received grant support from Cephalon/Teva, serves as a consultant to Merck, and on an advisory board for Noven and Merck. K.E. is a consultant on a Data Monitoring Committee for Merck, Sharp & Dohme. All other authors have no direct conflicts of interest or financial disclosures relevant to this manuscript. Publisher Copyright: © 2015 by The North American Menopause Society.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - Objective: Our objective was to identify symptom clusters using standardized measures completed by participants in the Menopausal Strategies: Finding Lasting Answers to Symptoms and Health clinical trial at baseline, including hot flash interference, and sleep, depressive, anxiety, and pain symptoms. Methods: Data from all women randomized to interventions and controls from Menopausal Strategies: Finding Lasting Answers to Symptoms and Health studies 1, 2, and 3 (N=899) were included; 797 with complete data were used in the analyses. Scores from standardized measures obtained at baseline included the following: Hot Flash-Related Daily Interference Scale, Insomnia Severity Index, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9 measure of depressed mood, Generalized Anxiety Disorder, and Brief Pain Inventory PEG scores (pain intensity [P], interference with enjoyment of life [E], and interference with daily activity [G]). Latent class analysis was used to identify symptom clusters using standardized scale scores and their established cut points. Results: We identified five classes using the Bayesian Information Criterion and the Akaike Information Criterion. Women in classes 1 and 2 had high hot flash interference levels relative to the others, and class 1 (10.5% of total) included severe hot flash interference, severe sleep symptoms, and moderately severe pain symptoms (hot flash, sleep, pain). In class 2 (14.1%), severe hot flash interference was paired with the severe sleep symptoms, and moderate to severe depressed and anxious mood symptoms and pain (hot flash, sleep, mood, pain). In class 3 (39.6%), women reported moderately severe sleep symptoms with moderate hot flash interference, and low severity mood and pain symptoms (hot flash, sleep). Those in class 4 (7.0%) reported moderate hot flash interference with severe levels of anxiety and depressed mood symptoms, but low levels of other symptoms (hot flash, mood). Women in class 5 (28.7%) reported the lowest levels of all the five symptoms (low severity symptoms). Conclusions: Women meeting hot flash frequency criteria for inclusion in clinical trials exhibited multiple co-occurring symptoms that clustered into identifiable groups according to symptom interference and severity. Variability of symptom profiles between the classes was evident, indicating that the classes were composed of differing symptom types and not simply differing severity levels. These symptom clusters may be useful phenotypes for differentiating treatment effects or evaluating associations with biomarkers or genes.

AB - Objective: Our objective was to identify symptom clusters using standardized measures completed by participants in the Menopausal Strategies: Finding Lasting Answers to Symptoms and Health clinical trial at baseline, including hot flash interference, and sleep, depressive, anxiety, and pain symptoms. Methods: Data from all women randomized to interventions and controls from Menopausal Strategies: Finding Lasting Answers to Symptoms and Health studies 1, 2, and 3 (N=899) were included; 797 with complete data were used in the analyses. Scores from standardized measures obtained at baseline included the following: Hot Flash-Related Daily Interference Scale, Insomnia Severity Index, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9 measure of depressed mood, Generalized Anxiety Disorder, and Brief Pain Inventory PEG scores (pain intensity [P], interference with enjoyment of life [E], and interference with daily activity [G]). Latent class analysis was used to identify symptom clusters using standardized scale scores and their established cut points. Results: We identified five classes using the Bayesian Information Criterion and the Akaike Information Criterion. Women in classes 1 and 2 had high hot flash interference levels relative to the others, and class 1 (10.5% of total) included severe hot flash interference, severe sleep symptoms, and moderately severe pain symptoms (hot flash, sleep, pain). In class 2 (14.1%), severe hot flash interference was paired with the severe sleep symptoms, and moderate to severe depressed and anxious mood symptoms and pain (hot flash, sleep, mood, pain). In class 3 (39.6%), women reported moderately severe sleep symptoms with moderate hot flash interference, and low severity mood and pain symptoms (hot flash, sleep). Those in class 4 (7.0%) reported moderate hot flash interference with severe levels of anxiety and depressed mood symptoms, but low levels of other symptoms (hot flash, mood). Women in class 5 (28.7%) reported the lowest levels of all the five symptoms (low severity symptoms). Conclusions: Women meeting hot flash frequency criteria for inclusion in clinical trials exhibited multiple co-occurring symptoms that clustered into identifiable groups according to symptom interference and severity. Variability of symptom profiles between the classes was evident, indicating that the classes were composed of differing symptom types and not simply differing severity levels. These symptom clusters may be useful phenotypes for differentiating treatment effects or evaluating associations with biomarkers or genes.

KW - Hot flashes

KW - Menopause

KW - Mood

KW - Pain

KW - Sleep disturbances

KW - Symptom clusters

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Symptom clusters among MsFLASH clinical trial participants

Abstract

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Keywords

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