Publications by authors named "Janet S Carpenter"

155 Publications

Review of menopausal palpitations measures.

Womens Midlife Health 2021 May 31;7(1). Epub 2021 May 31.

College of Pharmacy, Purdue University, West Lafayette, IN, 47907, USA.

Palpitations are reported commonly by women around the time of menopause as skipped, missed, irregular, and/or exaggerated heartbeats or heart pounding. However, much less is known about palpitations than other menopausal symptoms such as vasomotor symptoms. The objective of this review was to integrate evidence on menopausal palpitations measures. Keyword searching was done in PubMed, CINAHL, and PsycINFO for English-language, descriptive articles containing data on menopause and palpitations and meeting other pre-specified inclusion criteria. Of 670 articles, 110 met inclusion criteria and were included in the review. Results showed that 11 different measures were used across articles, with variability within and between measures. Inconsistencies in the wording of measurement items, recall periods, and response options were observed even when standardized measures were used. Most measures were limited to assessing symptom presence and severity. Findings suggest that efforts should be undertaken to (1) standardize conceptual and operational definitions of menopausal palpitations and (2) develop a patient-friendly, conceptually clear, psychometrically sound measure of menopausal palpitations.
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http://dx.doi.org/10.1186/s40695-021-00063-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8167994PMC
May 2021

Hypnosis Intervention for Sleep Disturbance: Determination of Optimal Dose and Method of Delivery for Postmenopausal Women.

Int J Clin Exp Hypn 2021 May 28:1-23. Epub 2021 May 28.

College of Education, University of Texas at Austin, USA.

Sleep disturbances are a pervasive problem among postmenopausal women, with an estimated 40 to 64% reporting poor sleep. Hypnosis is a promising intervention for sleep disturbances. This study examined optimal dose and delivery for a manualized hypnosis intervention to improve sleep. Ninety postmenopausal women with poor sleep were randomized to 1 of 4 interventions: 5 in-person, 3 in-person, 5 phone, or 3 phone contacts. All received hypnosis audio recordings, with instructions for daily practice for 5 weeks. Feasibility measures included treatment satisfaction ratings and practice adherence. Sleep outcomes were sleep quality, objective and subjective duration, and bothersomeness of poor sleep. Results showed high treatment satisfaction, adherence, and clinically meaningful (≥ 0.5 ) sleep improvement for all groups. Sleep quality significantly improved, < .05, = .70, with no significant differences between groups, with similar results for the other sleep outcomes across all treatment arms. Comparable results between phone and in-person groups suggest that a unique "dose" and delivery strategy is highly feasible and can have clinically meaningful impact. This study provides pilot evidence that an innovative hypnosis intervention for sleep (5 phone contacts with home practice) reduces the burden on participants while achieving maximum treatment benefit.
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http://dx.doi.org/10.1080/00207144.2021.1919520DOI Listing
May 2021

A core outcome set for genitourinary symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative.

Menopause 2021 May 10. Epub 2021 May 10.

Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University. Melbourne, Australia School of Nursing, Indiana University, Indianapolis, IN Department of Obstetrics and Gynaecology, University of Chicago, Chicago, IL Red Hot Mamas North America, Inc., New York, NY Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY Department of Obstetrics and Gynaecology, University Hospitals Dorset NHS Trust, Poole, Dorset, UK Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University London, UK Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand Department of Obstetrics and Gynaecology, Fortis Escort Hospital, Jaipur, India Department of Gynaecology and Obstetrics, University of Muenster, Muenster, Germany Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia Department of Reproductive and Maternal Medicine, School of Medicine, University of Glasgow, Glasgow, UK Departments of Psychiatry, Psychology and Obstetrics and Gynecology, University of Illinois at Chicago, Chicago IL Vincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, University of Pavia, Pavia, Italy Department of Urology, UIC College of Medicine, Chicago IL Queen Charlotte's and Chelsea and Westminster Hospitals, Imperial College London, London, UK Auckland District Health Board, Auckland, New Zealand Department of Obstetrics and Gynecology, Midlife Women's Health Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA Department of Obstetrics and Gynecology, George Washington University, Washington, DC Department of Obstetrics and Gynecology, University Clinic Inselspital Bern, Bern, Switzerland Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Canada.

Objective: Genitourinary symptoms, such as vaginal dryness and pain with sex, are commonly experienced by postmenopausal women. Comparing treatments for these genitourinary symptoms are restricted by the use of different outcome measures in clinical trials and the omission of outcomes, which may be relevant to women. The aim of this project was to develop a Core Outcome Set (COS) to be reported in clinical trials of treatments for genitourinary symptoms associated with menopause.

Methods: We performed a systematic review of randomized controlled trials of treatments for genitourinary symptoms associated with menopause and extracted their outcomes. This list was refined and entered into a two-round modified Delphi survey, which was open to clinicians, researchers, and postmenopausal women from November 2019 to March 2020. Outcomes were scored on a nine-point scale from "not important" to "critically important." The final COS was determined following two international consensus meetings.

Results: A total of 26 unique outcomes were included in the Delphi process, which was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to the Delphi scores to categorize outcomes by importance, which informed the e consensus meetings, attended by 43 participants from 21 countries. The final COS includes eight outcomes: (1) pain with sex, (2) vulvovaginal dryness, (3) vulvovaginal discomfort or irritation, (4) discomfort or pain when urinating, (5) change in most bothersome symptom, (6) distress, bother or interference of genitourinary symptoms, (7) satisfaction with treatment, (8) side effects of treatment.

Conclusion: These eight core outcomes reflect the joint priorities of postmenopausal women, clinicians, and researchers internationally. Standardized collection and reporting of these outcomes in clinical trials will facilitate the comparison of different treatments for genitourinary symptoms, advance clinical practice, and ultimately improve outcomes for symptomatic women.

Video Summary:http://links.lww.com/MENO/A765.
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http://dx.doi.org/10.1097/GME.0000000000001788DOI Listing
May 2021

A core outcome set for vasomotor symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative.

Menopause 2021 Apr 26. Epub 2021 Apr 26.

Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia Obstetrics and Gynaecology, Eastern Virginia Medical School, Norfolk, VA Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia School of Nursing, Indiana University, Indianapolis, IN Department of Obstetrics and Gynaecology, University of Chicago, Chicago, IL Red Hot Mamas North America, Inc, Town of Ridgefield, CT Obstetrics and Gynecology, New York University School of Medicine, New York, NY Department of Obstetrics and Gynaecology, University Hospitals Dorset NHS Trust, Poole, Dorset, UK Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University London, London, UK Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand Connors Center for Women's Health and Gender Biology and the Department of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA Department of Obstetrics and Gynaecology, Fortis Escort Hospital, Jaipur, India Department of Gynaecology and Obstetrics, University of Muenster, Muenster, Germany Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia Amsterdam Reproduction and Development, Center for Reproductive Medicine, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands Department of Reproductive and Maternal medicine, School of Medicine, University of Glasgow, Glasgow, UK University of Illinois at Chicago, Departments of Psychiatry, Psychology and Obstetrics and Gynecology, Chicago, IL Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy Queen Charlotte's and Chelsea and Chelsea and Westminster Hospitals, Imperial College London, London, UK Auckland District Health Board, Auckland, New Zealand Midlife Women's Health Center, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA Department of Obstetrics and Gynecology, George Washington University, Washington, DC Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Canada.

Objective: Vasomotor symptoms (VMS) (hot flashes and night sweats) affect most women over the menopause transition. Comparing the safety and effectiveness of treatments for vasomotor symptoms is limited by the use of inconsistent outcome measures, and uncertainty as to which outcomes are most important to symptomatic women. To address this, we have developed a Core Outcome Set (COS) for use in clinical trials of treatments for VMS.

Methods: We systematically reviewed the primary outcomes measured in randomized controlled trials of treatments for VMS. These were refined and entered into a two-round modified Delphi survey completed by clinicians, researchers, and postmenopausal women between November 2019 and March 2020. Outcomes were scored on a nine-point scale from "not important" to "critically important." Two international consensus meetings were held to finalize the COS.

Results: Based on the systematic review, 13 separate outcomes were included in the Delphi process. This was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to categorize importance scores obtained during Round 2 of the Delphi survey. These informed discussions at the consensus meetings which were attended by 56 participants from 28 countries. The final COS includes six outcomes: 1) frequency of VMS, 2) severity of VMS, 3) distress, bother or interference caused by VMS, 4) impact on sleep, 5) satisfaction with treatment, and 6) side-effects of treatment.

Conclusion: Implementation of this COS will: better enable research studies to accurately reflect the joint priorities of postmenopausal women, clinicians and researchers, standardize outcome reporting, and facilitate combining and comparing results from different studies, and ultimately improve outcomes for women with bothersome VMS.

Video Summary:http://links.lww.com/MENO/A763.
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http://dx.doi.org/10.1097/GME.0000000000001787DOI Listing
April 2021

Leadership corner: Living legends Drs. Berkowitz and Malone.

Nurs Outlook 2021 Apr 11. Epub 2021 Apr 11.

University of Kansas Medical Center School of Nursing, Kansas City, KS. Electronic address:

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http://dx.doi.org/10.1016/j.outlook.2021.03.006DOI Listing
April 2021

Associations Between Dysmenorrhea Symptom-Based Phenotypes and Vaginal Microbiome: A Pilot Study.

Nurs Res 2021 Mar 13. Epub 2021 Mar 13.

Indiana University School of Nursing, Indianapolis, IN Loyola University Chicago, Stritch School of Medicine, Department of Medicine, Maywood, IL Indiana University School of Medicine, Department of Microbiology and Immunology, Indianapolis, IN Vincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA Obstetrics, Gynecology & Reproductive Biology, Harvard Medical School, Boston, MA Indiana University School of Medicine, Department of Pediatrics, Indianapolis, IN.

Background: Dysmenorrhea is highly prevalent; it places women at risk for other chronic pain conditions. There is a high degree of individual variability in menstrual pain severity, the number of painful sites, and co-occurring gastrointestinal symptoms. Distinct dysmenorrhea symptom-based phenotypes were previously identified, but the biological underpinnings of these phenotypes are less known. One underexplored contributor is the vaginal microbiome. The vaginal microbiota differs significantly among reproductive-age women and may modulate as well as amplify reproductive tract inflammation, which may contribute to dysmenorrhea symptoms.

Objectives: The objective of this study was to examine associations between dysmenorrhea symptom-based phenotypes and vaginal microbiome compositions on- and off-menses.

Methods: We conducted a prospective, longitudinal, pilot study of 20 women (aged 15-24) grouped into three dysmenorrhea symptom-based phenotypes: "mild localized pain," "severe localized pain," and "severe multiple pain and gastrointestinal symptoms." Over one menstrual cycle, participants provided vaginal swabs when they were on-menses and off-menses. We assayed the vaginal microbiome using 16S rRNA gene sequencing. Permutational multivariate analysis of variance tests were used to compare microbiome compositions across phenotypes, with heat maps generated to visualize the relative abundance of bacterial taxa.

Results: The vaginal microbiome compositions (n = 40) were different across the three phenotypes. After separating the on-menses (n = 20) and off-menses (n = 20) specimens, the statistically significant difference was seen on-menses, but not off-menses. Compared to the "mild localized pain" phenotype, participants in the "multiple severe symptoms" phenotype had a lower lactobacilli level and a higher abundance of Prevotella, Atopobium, and Gardnerella when on-menses. We also observed trends of differences across phenotypes in vaginal microbiome change from off- to on-menses.

Discussion: The study provides proof-of-concept data to support larger studies on associations between dysmenorrhea symptom-based phenotypes and vaginal microbiome that might lead to new intervention targets and/or biomarkers for dysmenorrhea. This line of research has the potential to inform precision dysmenorrhea treatment that can improve women's quality of life.
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http://dx.doi.org/10.1097/NNR.0000000000000510DOI Listing
March 2021

Leadership corner: Living Legends Part 1.

Nurs Outlook 2021 Feb 26. Epub 2021 Feb 26.

University of Pennsylvania School of Nursing, Philadelphia, PA.

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http://dx.doi.org/10.1016/j.outlook.2020.12.010DOI Listing
February 2021

Genitourinary Symptoms in Breast Cancer Survivors: Prevalence, Correlates, and Relationship With Sexual Functioning.

Oncol Nurs Forum 2021 03;48(2):229-241

Indiana University.

Objectives: To evaluate (a) the prevalence of genitourinary symptoms, (b) which demographic and clinical factors predict genitourinary symptoms, and (c) the association between genitourinary symptoms and sexual functioning in breast cancer survivors.

Sample & Setting: A secondary analysis of cross-sectional, patient-reported outcomes data from 1,085 breast cancer survivors was conducted.

Methods & Variables: Prevalence and correlations with demographics, clinical factors, and sexual functioning were identified using descriptive analysis, multivariable logistic regression analysis, chi-square tests, t tests, and Pearson correlation coefficients.

Results: Symptoms included vaginal/vulvar irritation, pelvic discomfort, problems with urinary control, vaginal infection, and vaginal bleeding. Younger age, more comorbidities, and taking treatment for menopausal symptoms were significantly related to reporting genitourinary symptoms. Experiencing more symptoms was associated with lower sexual functioning.

Implications For Nursing: The prevalence, correlates, and relationship of genitourinary symptoms with sexual functioning supports the assessment and treatment of these symptoms as part of routine care for breast cancer survivors.
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http://dx.doi.org/10.1188/21.ONF.229-241DOI Listing
March 2021

Leadership corner: COVID courage awardees.

Nurs Outlook 2021 Mar-Apr;69(2):243-245. Epub 2021 Feb 5.

Indiana University School of Nursing, Indianapolis, IN. Electronic address:

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http://dx.doi.org/10.1016/j.outlook.2021.01.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7863771PMC
April 2021

The Mindful Leader.

Nurs Outlook 2021 May-Jun;69(3):489-490. Epub 2021 Jan 20.

Indiana University School of Nursing, Indianapolis, IN. Electronic address:

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http://dx.doi.org/10.1016/j.outlook.2020.12.008DOI Listing
January 2021

Attitudinal and social predictors of adherence to oral endocrine therapy: A psychometrically-informed model.

J Health Psychol 2020 Dec 18:1359105320982039. Epub 2020 Dec 18.

Indiana University, USA.

There is a need for a psychometrically-informed model identifying attitudinal and social factors explaining adherence to oral endocrine therapy (OET) for women with hormone receptor positive breast cancer. This study tested a model with variables selected by stringent psychometric criteria, including attitudes about benefit and burden, patient-practitioner alliance and confusion, and positive and negative interpersonal interactions. Self-report scales were completed by 150 current or past OET users. Fourteen correlations and six mediated pathways implied by the model were tested. All hypothesized associations were significant. This preliminary study suggests the model is a valuable framework for OET adherence research and intervention.
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http://dx.doi.org/10.1177/1359105320982039DOI Listing
December 2020

Engaging Adolescent and Young Adults in Microbiome Sample Self-Collection: Strategies for Success.

Biol Res Nurs 2021 Jul 9;23(3):402-407. Epub 2020 Dec 9.

Department of Pediatrics, 15841Indiana University School of Medicine, Indianapolis, IN, USA.

Human microbiome research provides rich opportunities to elucidate factors influencing health, uncover novel biomarkers, and expand disease treatment options. A well-conducted microbiome study depends not only on a rigorous design but also on successfully engaging participants in collecting quality samples. In this paper, we aim to describe (1) strategies our team used to engage adolescents and young adults in vaginal and gut microbiome sample self-collection and (2) their effectiveness. In our prospective, longitudinal, feasibility study of 20 female adolescents and young adults, research participants self-collected vaginal and gut microbiome samples at home. Using a participatory and iterative process, we developed strategies to engage participants in sample self-collection, including (1) providing clear instructions to ensure comprehension and buy-in, (2) providing a user-friendly take-home package, (3) minimizing disgust/embarrassment associated with sample collection, and (4) follow-up communications to facilitate sample collections and return. With these strategies, we achieved 100% participant retention and 100% sample return rates. All samples ( = 80, 100%) were usable for downstream 16s rRNA gene sequencing and analysis. All participants rated the study procedures as acceptable, and qualitative data showed that strategies were well received by participants. This study suggests that carefully planning and implementing strategies to engage participants in sample self-collection can result in high degrees of participant compliance, sample quality, and participant satisfaction in microbiome research.
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http://dx.doi.org/10.1177/1099800420979606DOI Listing
July 2021

A Menopause Strategies-Finding Lasting Answers for Symptoms and Health (MsFLASH) Investigation of Self-Reported Menopausal Palpitation Distress.

J Womens Health (Larchmt) 2021 04 20;30(4):533-538. Epub 2020 Nov 20.

Department of Family Medicine and Public Health, University of California, San Diego, California, USA.

Study to describe the degree of menopausal palpitation distress and its demographic, clinical, symptom, and quality-of-life (QOL) correlates. Analysis of existing, baseline, data from peri- and postmenopausal women, 42 to 62 years of age, who participated in the Menopause Strategies-Finding Lasting Answers for Symptoms and Health (MsFLASH) clinical trials testing interventions for vasomotor symptoms ( = 759). Up to 46.8% of menopausal women report having palpitations, yet the symptom is relatively understudied. Little is known about palpitation distress or its correlates. Degree of distress from "heart racing or pounding" was self-reported over the past two weeks as "not at all," "a little bit," "moderately," "quite a bit," or "extremely." Other measures included self-report forms, clinic-verified body mass index (BMI), vasomotor symptom diaries, and validated symptom and QOL tools. The percentage who reported palpitation distress was 19.6%, 25.2%, and 33.5% in the three trials or 25.0% overall. In multivariate analysis, the odds of reporting palpitation distress was lower in past smokers (odds ratio [OR] = 0.59 [95% confidence interval (CI) 0.38-0.90]) and current smokers (OR = 0.48 [0.27-0.87]) relative to never-smokers and lower with every 5 kg/m higher BMI (OR = 0.82 [0.69-0.98]).The odds of reporting palpitation distress was higher with every five point more severe insomnia (OR = 1.28 [1.05-1.54]), five point worse depressive symptoms (OR = 1.47 [1.11-1.95]), five point worse perceived stress (OR = 1.19 [1.01-1.39]), and one point worse menopausal QOL (OR = 1.29 [1.06-1.57]). Menopausal palpitation distress is common and associated with demographic, clinical, symptom, and QOL factors. Findings can be used for screening in clinical practice and to justify additional research on this understudied symptom.
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http://dx.doi.org/10.1089/jwh.2020.8586DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8064942PMC
April 2021

Fezolinetant findings can fuel future instrumentation inquiries.

Menopause 2020 12;27(12):1347

School of Nursing, Indiana University, Indianapolis, IN.

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http://dx.doi.org/10.1097/GME.0000000000001648DOI Listing
December 2020

Spillover from a Solution to School's Survey Overload.

West J Nurs Res 2021 Feb 8;43(2):103-104. Epub 2020 Oct 8.

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http://dx.doi.org/10.1177/0193945920963278DOI Listing
February 2021

Perceived Ineffectiveness of Pharmacological Treatments for Dysmenorrhea.

J Womens Health (Larchmt) 2020 Oct 7. Epub 2020 Oct 7.

Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA.

Dysmenorrhea affects most reproductive-aged women. Common dysmenorrhea treatments vary in their effectiveness across individuals. Little is known about factors associated with perceived treatment ineffectiveness. The objectives of this study were to describe the perceived ineffectiveness of common pharmacological treatments for dysmenorrhea and investigate factors associated with perceived treatment ineffectiveness. In this cross-sectional study, 678 women with dysmenorrhea (aged 14-42) provided data on perceived treatment ineffectiveness, dysmenorrhea symptom-based phenotypes, demographics, clinical factors, and psychobehavioral characteristics. We used Fisher's exact tests to compare treatment ineffectiveness across three symptom-based phenotypes. We used logistic regressions to explore associations of phenotype, demographic, clinical, and psychobehavioral correlates of perceived treatment ineffectiveness. Percentages perceiving treatments as ineffective were 29.3%-35.6% nonsteroidal anti-inflammatory drugs, 49.9% acetaminophen, and 39.3% combined oral contraceptive pills (OCPs). Factors associated with perceived ineffectiveness varied across treatments and included symptom-based phenotypes, clinical, and psychobehavioral factors. For ibuprofen and acetaminophen, women with severe (vs. mild) pain phenotype and higher number of chronic pain conditions were more likely to perceive the treatments as ineffective. For OCPs, women with severe pain (vs. mild) phenotype, comorbid gynecological condition, less anxiety, and worse depressive symptoms were more likely to perceive the treatment as ineffective. A significant percentage of women reported ineffectiveness of dysmenorrhea treatments. Phenotypes, clinical, and psychobehavioral factors were associated with treatment ineffectiveness. Future research should test if symptom-based phenotypes are associated with treatment effectiveness in clinical trials and investigate other factors that affect dysmenorrhea treatment effectiveness, so treatments can be tailored to individuals.
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http://dx.doi.org/10.1089/jwh.2020.8581DOI Listing
October 2020

Dysmenorrhea Symptom-Based Phenotypes: A Replication and Extension Study.

Nurs Res 2021 Jan/Feb;70(1):24-33

Chen X. Chen, PhD, RN, is Assistant Professor, Indiana University School of Nursing, Indianapolis. Janet, S. Carpenter, PhD, RN, FAAN, is Distinguished Professor, Audrey Geisel Endowed Chair in Innovation, Associate Dean for Research, Indiana University School of Nursing, Indianapolis. Susan Ofner MS, is Biostatistician, Department of Biostatistics, Indiana University School of Medicine, Indianapolis. Michelle LaPradd, MS, MBA, is Biostatistician and PhD Student, Department of Biostatistics, Indiana University School of Medicine, Indianapolis. J. Dennis Fortenberry, MD, MS, is Donald Orr, MD Professor of Adolescent Medicine and Chief of the Division of Adolescent Medicine, Department of Pediatrics, Indiana University School of Medicine, Indianapolis.

Background: Dysmenorrhea is a prevalent pain condition among women and a risk factor for other chronic pain conditions. Individuals vary in dysmenorrhea pain severity, the number of painful sites, and co-occurring gastrointestinal symptoms. Three dysmenorrhea symptom-based phenotypes were previously identified using latent class analysis; however, there is a need to validate these in an independent sample, so they can be used in mechanistic and interventional research. There is also a need to further characterize dysmenorrhea symptom-based phenotypes in terms of demographic, clinical, and psychobehavioral characteristics so they can be used to inform precision dysmenorrhea treatment.

Objectives: The study objectives were to (a) determine whether the same dysmenorrhea symptom-based phenotypes would be found in a new sample; (b) determine whether including demographic, clinical, and psychobehavioral covariates in latent class analyses would change individuals' phenotype memberships; and (c) investigate relationships between dysmenorrhea symptom-based phenotypes and demographic, clinical, and psychobehavioral characteristics.

Methods: This cross-sectional survey study included 678 women (aged 14-42 years) with dysmenorrhea. Participants reported dysmenorrhea symptom severity, demographic, clinical (comorbid chronic pain and gynecological conditions), and psychobehavioral characteristics (perceived stress, anxiety, depression, sleep disturbance, and pain catastrophizing). We used latent class analysis to identify symptom-based phenotypes. We compared analyses with and without covariates (i.e., demographic, clinical, and psychobehavioral characteristics) to determine if individuals' phenotype memberships changed. We then examined associations between phenotypes and demographic, clinical, and psychobehavioral characteristics.

Results: We reproduced three dysmenorrhea symptom-based phenotypes: the "mild localized pain" phenotype (characterized by mild abdominal cramps), the "severe localized pain" phenotype (characterized by severe abdominal cramps), and the "multiple severe symptoms" phenotype (characterized by severe pain at multiple locations and gastrointestinal symptoms). Analyses with and without covariates had little effect on individuals' phenotype membership. Race, comorbid chronic pain condition, endometriosis, and pain catastrophizing were significantly associated with the dysmenorrhea phenotypes.

Discussion: Findings provide a foundation to further study mechanisms of dysmenorrhea symptom heterogeneity and develop dysmenorrhea precision treatments. The three dysmenorrhea symptom-based phenotypes were validated in a second sample. Demographic, clinical, and psychobehavioral factors were associated with dysmenorrhea symptom-based phenotypes.
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http://dx.doi.org/10.1097/NNR.0000000000000477DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7736149PMC
February 2021

Operationalizing Postdischarge Recovery From Laparoscopic Sacrocolpopexy for the Preoperative Consultative Visit.

Female Pelvic Med Reconstr Surg 2020 Sep 8. Epub 2020 Sep 8.

Department of Psychology, School of Science, Indiana University-Purdue University Indianapolis, Indianapolis, IN.

Objective: The objective was to establish a threshold for postdischarge surgical recovery from laparoscopic sacrocolpopexy for the preoperative consultative visit to answer the "what is my recovery time?"

Question:

Methods: Study participants (N = 171) with stage 2 or worse pelvic organ prolapse undergoing laparoscopic sacrocolpopexy who completed postoperative surveys at 4 time points. Postdischarge Surgical Recovery 13 (PSR13) scores were anchored to a Global Surgical Recovery (GSR) tool (if 100% recovery is back to your usual health, what percentage of recovery are you now?). Weighted mean PSR13 scores were calculated as a sum of the products variable when patients considered themselves 80 to less than 85, 85 to less than 90, 90 to less than 95, or 95 to 100 percent recovered on the GSR tool. The percentage of study participants recovered at postdischarge day 7, 14, 42, and 90 was calculated based on a comparison between the GSR scores and weighted mean PSR13 scores.

Results: A PSR13 score of 80 or greater, corresponding to 85% or greater recovery, was seen in 55.6% (42 days) and 50.9% (90 days) of study participants, respectively, establishing this numeric threshold as representing "significant" postdischarge recovery after laparoscopic sacrocolpopexy. At 14 days after discharge, only 16.4% of the study population achieved this PSR13 score.

Conclusions: Most study subjects were "significantly" recovered at 42 days after laparoscopic sacrocolpopexy using a PSR13 score of 80 or greater as a numeric threshold. There is a need to determine the population percentage of recovered study subjects at 30, 60, and beyond 90 days from laparoscopic sacrocolpopexy.
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http://dx.doi.org/10.1097/SPV.0000000000000942DOI Listing
September 2020

Solving School's Survey Request Overload.

West J Nurs Res 2021 Feb 31;43(2):151-155. Epub 2020 Aug 31.

Indiana University School of Nursing, Indianapolis, IN, USA.

Limited information is available on strategies for managing the large number of survey requests that reach an individual nursing school. This article addresses problems identified in managing survey requests and describes the implementation and evaluation of a solution. Identified problems included the appearance of endorsing studies of varying quality and rigor, overlap and competition between external study requests and internal studies, respondent burden, and level of anonymity and confidentiality. The solution included a school-wide policy for tracking and vetting study requests before they were distributed. Evaluation data show the number of requests received (total, by month and source, by target population), their disposition (withdrawn, approved, not approved for distribution), and quality improvement data on meeting a 30-day target turnaround time. Additional considerations are also discussed.
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http://dx.doi.org/10.1177/0193945920954781DOI Listing
February 2021

Development and Testing of the Dysmenorrhea Symptom Interference (DSI) Scale.

West J Nurs Res 2021 Apr 17;43(4):364-373. Epub 2020 Jul 17.

Indiana University School of Nursing, Indianapolis, IN, USA.

Dysmenorrhea affects most reproductive-age women and increases the risk of future pain. To evaluate dysmenorrhea interventions, validated outcome measures are needed. In this two-phase study, we developed and tested the dysmenorrhea symptom interference scale. During the scale-development phase ( = 30), we created a nine-item scale based on qualitative data from cognitive interviews. During the scale-testing phase ( = 686), we evaluated reliability, validity, and responsiveness to change. The scale measures how dysmenorrhea symptoms interfere with physical, mental, and social activities. Internal consistency was strong with Cronbach's > 0.9. Test-retest reliability was acceptable ( = 0.8). The scale showed satisfactory content validity, construct validity (supported by confirmatory factor analysis), concurrent validity, and responsiveness to change. The minimally important difference was 0.3 points on a scale with a possible total score ranging from 1 to 5. This new psychometrically sound scale can be used in research and clinical practice to facilitate the measurement and management of dysmenorrhea.
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http://dx.doi.org/10.1177/0193945920942252DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7854855PMC
April 2021

Delirium Severity Trajectories and Outcomes in ICU Patients. Defining a Dynamic Symptom Phenotype.

Ann Am Thorac Soc 2020 09;17(9):1094-1103

Center for Health Innovation and Implementation Science.

Delirium severity and duration are independently associated with higher mortality and morbidity. No studies to date have described a delirium trajectory by integrating both severity and duration. The primary aim was to develop delirium trajectories by integrating symptom severity and duration. The secondary aim was to investigate the association among trajectory membership, clinical characteristics, and 30-day mortality. A secondary analysis of the PMD (Pharmacologic Management of Delirium) randomized control trial (ClinicalTrials.gov Identifier: NCT00842608;  = 531) was conducted. The presence of delirium and symptom severity were measured at least daily for 7 days using the Confusion Assessment Method for the intensive care unit (CAM-ICU) and CAM-ICU-7 (on a scale of 0-7, with 7 being the most severe). Delirium trajectories were defined using an innovative, data-driven statistical method (group-based trajectory modeling [GBTM]) and SAS v9.4. A total of 531 delirious participants (mean age 60 yr [standard deviation = 16], 55% female, and 46% African American) were analyzed. Five distinct delirium trajectories were described (CAM-ICU-7: mean [standard deviation]); mild-brief (CAM-ICU-7: 0.5 [0.5]), severe-rapid recovers (CAM-ICU-7: 2.1 [1.0]), mild-accelerating (CAM-ICU-7: 2.2 [0.9]), severe-slow recovers (CAM-ICU-7: 3.9 [0.9]), and severe-nonrecovers (CAM-ICU-7: 5.9 [1.0]). Baseline cognition and race were associated with trajectory membership. Trajectory membership independently predicted 30-day mortality while controlling for age, sex, race, cognition, illness severity, and comorbidities. This secondary analysis described five distinct delirium trajectories based on delirium symptom severity and duration using group-based trajectory modeling. Trajectory membership predicted 30-day mortality.
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http://dx.doi.org/10.1513/AnnalsATS.201910-764OCDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462321PMC
September 2020

The protagonist is a neurokinin 1, 3 antagonist.

Menopause 2020 05;27(5):495

School of Nursing, Indiana University, Indianapolis, IN.

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http://dx.doi.org/10.1097/GME.0000000000001537DOI Listing
May 2020

Self-Hypnosis for Sleep Disturbances in Menopausal Women.

J Womens Health (Larchmt) 2020 03;29(3):461-463

Mind-Body Medicine Research Laboratory, Department of Psychology and Neuroscience, Baylor University, Waco, Texas.

Poor sleep is one of the most frequent health concerns among menopausal women. All stages of sleep can be impacted by the menopause transition. Negative outcomes of poor sleep are multidimensional and include poor physical, psychological, cognition, and social outcomes. Hypnosis is a nonpharmacological treatment for poor sleep and hot flashes in menopausal women. The goal of hypnosis is to educate and train subjects to perform self-hypnosis to alleviate the underlying symptom. The use of hypnosis as a treatment for poor sleep has shown benefits for both acute and chronic insomnia. Initial findings from the National Center for Complementary and Integrative Health (NCCIH) Hypnosis Intervention for Sleep in Menopause: Examination of Optimal Dose and Method of Delivery randomized control trial of 90 women were presented. Results showed that program and treatment satisfaction were high in all groups, adherence to daily practice met or exceeded adherence benchmarks. There were significant reduction of poor sleep quality in all groups with a significant increase in minutes slept in all groups. The majority of women also showed clinical improvements of duration. There were clinically meaningful improvements in reducing the perception of poor sleep quality in 50%-77% of women across time. Overall, the use of self-hypnosis as a treatment program for sleep problems related to menopause was acceptable for women. Data further support that hypnosis is a promising technique to improve sleep in menopausal women with sleep and hot flashes. Further research is ongoing on self-hypnosis delivery and implementation into wider populations of women using clear definition and control groups.
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http://dx.doi.org/10.1089/jwh.2020.8327DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7097677PMC
March 2020

Lights on MsFLASH: a review of contributions.

Menopause 2020 04;27(4):473-484

Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.

Objective: The Menopause Strategies: Finding Lasting Answers for Symptoms and Health clinical trials network was funded by the National Institutes of Health to find new ways to alleviate the most common, bothersome menopausal symptoms by designing and conducting multiple concurrent clinical intervention studies, accommodating a wide scope of populations and intervention strategies.

Methods: Trials were conducted in Boston, Indianapolis, Minneapolis, Oakland, Philadelphia, and Seattle, with the Data Coordinating Center in Seattle, and were designed with standardized eligibility criteria and endpoints. Primary outcomes focused on vasomotor symptoms, sleep quality and insomnia symptoms, and vaginal symptoms. Secondary outcomes included quality of life, sexual function, and mood.

Results: We completed five randomized clinical trials and three ancillary studies, testing nine interventions in over 1,300 women and collecting nearly 16,000 bio-specimens. Escitalopram, venlafaxine hydrochloride extended release, and low-dose estradiol diminished hot flashes by approximately 50% as compared with a 30% decrease by placebo. No benefits on vasomotor symptoms were observed with yoga or exercise compared with usual activity, nor with omega-3 supplementation compared with placebo. Cognitive behavioral therapy for insomnia reduced self-reported insomnia symptoms and improved overall sleep quality compared with menopause education control. We did not find significant benefit from a vaginal estradiol tablet or a vaginal moisturizer compared with placebo tablet and gel in diminishing the severity of vaginal symptoms.

Conclusions: The MsFLASH trials contributed substantially to our understanding of bothersome menopausal symptom treatment. It is important that clinicians counseling women about available treatment options consider all therapies-both nonhormonal and hormonal.
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http://dx.doi.org/10.1097/GME.0000000000001461DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8009305PMC
April 2020

An arts-based educational exhibit on menopausal hot flashes.

Menopause 2019 09;26(9):1062-1067

School of Nursing, Indiana University, Indianapolis, IN.

Objective: The aim of this study was to describe the development process, science, and symbolism of an arts-based educational exhibit designed to address myths, misinformation, negative imagery, and use of unproven treatments related to menopausal hot flashes.

Methods: The development process included iterative and informal feedback from a variety of individuals, a partnership with an experienced exhibit designer, and collaborations between artists and scientists.

Results: The resulting exhibit creates an environment where the public is immersed in accurate information about hot flashes. Although based on an iterative process, the resulting exhibit content reflects an estimated 500+ scientific studies, including those referenced in The North American Menopause Society position statements on hormone and nonhormone management of hot flashes. The seven main exhibit pieces convey scientific information and symbolize various aspects of women's experiences.

Conclusions: This innovative exhibit has high potential to be a disruptive innovation to address the preponderance of myths, misinformation, and negative imagery surrounding menopausal hot flashes and potentially decrease the use of unproven therapies.
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http://dx.doi.org/10.1097/GME.0000000000001365DOI Listing
September 2019

Public survey reactions to an arts-based educational menopausal hot flash exhibit.

Menopause 2019 09;26(9):989-993

The daVinci Pursuit, Indianapolis, IN.

Objective: The aim of this study was to obtain public survey reactions to concept art for an exhibit about menopausal hot flashes designed to stimulate learning, dispel myths, spur dialogue, and increase empathy.

Methods: Immediately before viewing the art, participants provided demographic information and answered one open-ended question. Immediately after viewing the art, participants answered the same open-ended question, one additional open-ended question, and completed quantitative survey questions.

Results: Overall, public reactions to the concept art were positive. Qualitative and quantitative data indicated that the public thought the exhibit was appealing, stimulated learning, dispelled myths, spurred desire to have conversations about hot flashes, and increased empathy for women with menopausal hot flashes.

Conclusions: The exhibit concept art was appealing and was reported to have a positive impact on the public. Study findings provide support for building the exhibit full-scale as a traveling educational resource that might change public discourse around menopausal hot flashes.
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http://dx.doi.org/10.1097/GME.0000000000001352DOI Listing
September 2019

Focus group reactions to an arts-based educational exhibit on menopausal hot flashes.

Menopause 2019 09;26(9):981-988

The daVinci Pursuit, Indianapolis, IN.

Objective: To assess public reactions to an arts-based educational exhibit designed to immerse and engage people in scientific facts to increase their conceptual understanding of hot flashes. Our ultimate goals were to stimulate learning and conversations about menopausal hot flashes to change interactions between menopausal women and providers, and menopausal women and other people (family, friends, etc). Focus groups reacted to the concept art (graphics, miniaturized model); and a questionnaire for quickly assessing reactions.

Methods: Using a qualitative descriptive methodology, six focus groups of diverse people (n = 50) aged 13 to 64 years described their reactions to the art and questionnaire. Recruitment methods were word of mouth, advertisements on university websites, and a university-based participant registry. Data were analyzed using qualitative content analysis and inductively derived codes.

Results: Reactions to the concept art were generally favorable. Participants remarked on appealing and less appealing aspects and age appropriateness. Appealing aspects were resonance with women's experiences, clear information, use of symbolism, and overall design. Less appealing aspects lacked resonance, contained confusing information, or unappealing design elements. Participants felt the exhibit should be open to all ages. The final questionnaire reflected participants' descriptions of the art's ability to stimulate learning, dispel myths, spur dialog, and increase empathy.

Conclusions: The concept art is an appropriate tool for improving knowledge and communication about hot flashes. Displaying the concept art and/or future full-scale exhibit in healthcare settings or public venues may facilitate learning and communication among three groups-menopausal women, healthcare providers, and others.
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http://dx.doi.org/10.1097/GME.0000000000001351DOI Listing
September 2019

Medication Exposure Patterns in Primary Care Patients Prescribed Pharmacogenetically Actionable Opioids.

Qual Rep 2018 Aug 7;23(8):1861-1875. Epub 2018 Aug 7.

Indiana University, Indianapolis, Indiana, USA.

Current approaches to assessing medication exposure fail to capture the complexity of the phenomenon and the context in which it occurs. This study's purpose was to develop a typology of subgroups of patients who share common patterns of medication exposure. To create the typology, we used an exemplar sample of 30 patients in a large public healthcare system who had been prescribed the pharmacogenetically actionable opioids codeine or tramadol. Data related to medication exposure were drawn from large data repositories. Using a person-oriented qualitative approach, eight subgroups of patients who shared common patterns of medication exposure were identified. The subgroups had one of five opioid prescription patterns (i.e., singular, episodic, switching, sustained, multiplex), and one of three types of primary foci of medical care (i.e., pain, comorbidities, both). The findings reveal medication exposure patterns that are dynamic, multidimensional, and complex, and the typology offers an innovative approach to assessing medication exposure.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6660172PMC
August 2018

Confirmatory factor analysis of the Insomnia Severity Index (ISI) and invariance across race: a pooled analysis of MsFLASH data.

Menopause 2019 08;26(8):850-855

School of Nursing, Indiana University, Indianapolis, IN.

Objective: Women's sleep at menopause is widely reported to be problematic. The Insomnia Severity Index (ISI) is a commonly used tool for quantifying sleep problems in clinical and research settings, but psychometric properties in postmenopausal women have not been reported. Our study aim was to examine the factor structure of the ISI in a large and diverse sample of midlife women with hot flashes.

Methods: Baseline data were from 899 women enrolled in one of the three clinical trials using similar entry criteria conducted by the Menopause Strategies Finding Lasting Answers to Symptoms and Health research network. We conducted confirmatory factor analyses for the total sample and within strata defined by race/ethnicity (black and white women).

Results: The ISI had two factors in the total sample. The two-factor structure was consistent across black and white women, with the exception of one item "difficulty falling asleep."

Conclusions: The ISI in midlife women with hot flashes is composed of two factors that capture dimensions of the insomnia severity and daytime impact. The instrument is a psychometrically sound scale appropriate for use in research and clinical practice to capture the severity and daytime impact of insomnia symptoms in diverse samples of midlife women with hot flashes. An abbreviated screening of two items could be considered to determine if further evaluation is needed of sleep complaints.
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http://dx.doi.org/10.1097/GME.0000000000001343DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6663566PMC
August 2019

Predictors of Postdischarge Surgical Recovery Following Laparoscopic Sacrocolpopexy: A Prospective Cohort Study.

Female Pelvic Med Reconstr Surg 2020 05;26(5):320-326

Department of Psychology, School of Science, Indiana University-Purdue University, Indianapolis, IN.

Objectives: Our aim was to identify sociodemographic/clinical, surgical, and psychosocial predictors of postdischarge surgical recovery after laparoscopic sacrocolpopexy.

Methods: Study participants (N = 171) with at least stage 2 pelvic organ prolapse completed a preoperative survey measuring hypothesized sociodemographic/clinical, surgical, and psychosocial recovery predictors followed by a postoperative survey at 4 time points (days 7, 14, 42, and 90) that included the Postdischarge Surgical Recovery 13 scale. One multivariate linear regression model was constructed for each time point to regress Postdischarge Surgical Recovery 13 scores on an a priori set of hypothesized predictors. All variables that had P < 0.1 were considered significant predictors of recovery because of the exploratory nature of this study and focus on model building rather than model testing.

Results: Predictors of recovery at 1 or more time points included the following: sociodemographic/clinical predictors: older age, higher body mass index, fewer comorbidities, and greater preoperative pain predicted greater recovery; surgical predictors: fewer perioperative complications and greater change in the leading edge of prolapse after surgery predicted greater recovery; psychosocial predictors: less endorsement of doctor's locus of control, greater endorsement of other's locus of control, and less sick role investment predicted greater recovery.

Conclusions: Identified sociodemographic/clinical, surgical, and psychosocial predictors should provide physicians with evidence-based guidance on recovery times for patients and family members. This knowledge is critical for informing future research to determine if these predictors are modifiable by changes to our narrative during the preoperative consultation visit. These efforts may reduce the postdischarge surgical recovery for patients with pelvic organ prolapse after laparoscopic sacrocolpopexy, accepting the unique demands on each individual's time.
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http://dx.doi.org/10.1097/SPV.0000000000000599DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6301123PMC
May 2020