Evidence map›Paper›PMID 26506500›Full record

ArticleMenopause (New York, N.Y.)2016

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

Abstract read
In one paragraph

Article in Menopause (New York, N.Y.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.

  1. Pooled it
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  14. Lights on MsFLASH: a review of contributions.Menopause (New York, N.Y.) · 2020
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 1 country.

Nancy Fugate Woods1Biobehavioral Nursing, University of Washington 2Fred Hutchinson Cancer Research Center, Seattle, WA 3Science of Nursing Care, School of Nursing, Indiana University, Indianapolis, IN 4Center for Women's Mental Health; Perinatal and Reproductive Psychiatry Clinical Research Program, Massachusetts General Hospital, Boston, MA 5Department of Medicine and Division of Epidemiology and Community Health, University of Minnesota 6Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN 7Departments of Obstetrics/Gynecology and Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 8Harvard Medical School, Department of Psychiatry, Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, MA 9Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA.
Chancellor Hohensee
Janet S Carpenter
Lee Cohen
Kristine Ensrud
Ellen W Freeman
Katherine A Guthrie
Hadine Joffe
Andrea Z LaCroix
Julie L Otte
National Institutes of Health · USIndiana Clinical and Translational Sciences Institute · USMinneapolis VA Health Care System · USFred Hutch Cancer Center · USUniversity of Minnesota · USUniversity of Pennsylvania · US

Funding

Menopausal Symptoms Initiative-Finding Lasting Answers for Sweats and Hot FlashesU01AG032699 · NIA · FRED HUTCHINSON CANCER RESEARCH CENTER · PI GUTHRIE, KATHERINE ADAMS, LACROIX, ANDREA Z. · 2008 to 2012
$13.5M
MsFLASH: Living a Healthy MenopauseR01AG048209 · NIA · FRED HUTCHINSON CANCER RESEARCH CENTER · PI GUTHRIE, KATHERINE ADAMS, LACROIX, ANDREA Z. · 2015 to 2019
$7.2M
MSI-FLASH: Relative Efficacy of Hormonal and Non-Hormonal Interventions for VMSU01AG032700 · NIA · MASSACHUSETTS GENERAL HOSPITAL · PI COHEN, LEE S, JOFFE, HADINE · 2008 to 2012
$1.7M
MSI FLASH: An RCT of Yoga and Ultra Low-Dose Estrogen Gel for Vasomotor SymptomsU01AG032682 · NIA · KAISER FOUNDATION HEALTH PLAN OF WASHINGTON · PI NEWTON, KATHERINE M. · 2008 to 2012
$1.7M
Efficacy of an SSRI for Menopausal Symptoms in Perimenopausal WomenU01AG032656 · NIA · UNIVERSITY OF PENNSYLVANIA · PI FREEMAN, ELLEN W · 2008 to 2012
$1.5M
MSI-FLASH: Paced Respiration for Breast Cancer SurvivorsU01AG032659 · NIA · INDIANA UNIVERSITY INDIANAPOLIS · PI CARPENTER, JANET S · 2008 to 2012
$1.5M
MSI-FLASH: An Exercise Intervention for Women with Menopausal SymptomsU01AG032669 · NIA · KAISER FOUNDATION RESEARCH INSTITUTE · PI CAAN, BETTE J · 2008 to 2012
$1.5M
NCRR NIH HHS UL1RR02571NIA NIH HHS R01 AG048209NIA NIH HHS U01 AG032656NIA NIH HHS U01 AG032659NIA NIH HHS U01AG032659NIA NIH HHS U01 AG032669NIA NIH HHS U01AG032669NIA NIH HHS U01 AG032682NIA NIH HHS U01AG032682NIA NIH HHS U01 AG032699NIA NIH HHS U01AG032699NIA NIH HHS U01 AG032700NIA NIH HHS U01AG032700
6 · The paper itself

Abstract

objectiveOur 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.

methodsData 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.

resultsWe 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).

conclusionsWomen 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.

Indexed as

MenopauseSeverity of Illness IndexAnxietyCluster AnalysisDepressionFemaleHealth StatusHot FlashesHumansMiddle AgedSleep Initiation and Maintenance DisordersSurveys and QuestionnairesWomen's Health

Identifiers

PMID26506500
PMCPMC4731298
OpenAlexW2198942734

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.