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"Monahan, Patrick O."
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A randomized trial of grant writing coaching groups: Baseline analysis of early-career scientists’ research background, demographics, and mentorship variables
by
McGee, Richard
,
Jones, Harlan P.
,
Faupel-Badger, Jessica M.
in
Adult
,
Advisors
,
Biomedical Research
2025
Racial, ethnic, and gender disparities in academic career advancement persist in biomedical disciplines. One approach to addressing this problem is systematizing access to mentorship in critical skills such as grant writing. This report summarizes the baseline characteristics of early-career investigators who enrolled in a randomized trial of a group coaching intervention focused on National Institutes of Health (NIH) grant application development.
Surveys assessed participants' demographic characteristics, research focus, prior publications and grant submissions, self-efficacy for grantsmanship and career advancement, and access to mentorship. Two-sided t-test and Fisher's exact test were performed to compare baseline variables by gender identity (male/female) and by background from a racial or ethnic population that is an underrepresented minority group in biomedical research (non-URM/URM).
The study sample includes 271 faculty and 96 postdoctoral fellows. Sixty-two percent of faculty and 76.0% of postdoctoral fellows identified as female. Nearly half (45.4% of faculty, 49.0% of postdocs) were from URM populations in biomedical research. At baseline, most were conducting clinical and translational research at institutions with high levels of research activity. Past submission of NIH R-series applications was limited; 29.9% of faculty had submitted K applications. On average, participants had moderate levels of self-efficacy (in grantsmanship and career advancement) and research-related mentoring support. Male and non-URM participants had a higher mean number of previous publications. For the remaining variables, there were no or minimal differences by gender identity and URM status.
Early-career investigators from diverse backgrounds are motivated to engage in external grant writing coaching programs regardless of existing mentorship and other supports at their home institutions, suggesting that grant coaching can provide complementary value.
Journal Article
Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials
2021
Background
The PROMIS depression scales are reliable and valid measures that have extensive normative data in general population samples. However, less is known about how responsive they are to detect change in clinical settings and how their responsiveness compares to legacy measures. The purpose of this study was to assess and compare the responsiveness of the PROMIS and Patient Health Questionnaire (PHQ) depression scales in three separate samples.
Methods
We used data from three clinical trials (two in patients with chronic pain and one in stroke survivors) totaling 651 participants. At both baseline and follow-up, participants completed four PROMIS depression fixed-length scales as well as legacy measures: Patient Health Questionnaire 9-item and 2-item scales (PHQ-9 and PHQ-2) and the SF-36 Mental Health scale. We measured global ratings of depression change, both prospectively and retrospectively, as anchors to classify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area-under-curve analysis.
Results
The PROMIS depression and legacy scales had generally comparable responsiveness. Moreover, the four PROMIS depression scales of varying lengths were similarly responsive. In general, measures performed better in detecting depression improvement than depression worsening. For all measures, responsiveness varied based on the study sample and on whether depression improved or worsened.
Conclusions
Both PROMIS and PHQ depression scales are brief public domain measures that are responsive (i.e., sensitive to change) and thus appropriate as outcome measures in research as well as for monitoring treatment in clinical practice.
Trial registration
ClinicalTrials.gov ID: NCT01236521, NCT01583985, NCT01507688
Journal Article
Metabolic syndrome and total cancer mortality in the Third National Health and Nutrition Examination Survey
by
Gathirua-Mwangi, Wambui G.
,
Murage, Mwangi J.
,
Monahan, Patrick O.
in
Adult
,
Aged
,
Biomedical and Life Sciences
2017
Purpose
Although metabolic syndrome incidence has substantially increased during the last few decades, it largely remains unclear whether this metabolic disorder is associated with total cancer mortality. The present study was carried out to investigate this important question.
Methods
A total of 687 cancer deaths were identified from 14,916 participants in the third National Health and Nutrition Examination Survey by linking them to the National Death Index database through December 31, 2006. Cox proportional hazards regression was performed to calculate hazard ratios (HR) and 95% confidence intervals (CI) for total cancer mortality in relation to metabolic syndrome and its individual components.
Results
After adjustment for confounders, a diagnosis of metabolic syndrome was associated with 33% elevated total cancer mortality. Compared with individuals without metabolic syndrome, those with 3, 4 and 5 abnormal components had HRs (95% CIs) of 1.28 (1.03–1.59), 1.24 (0.96–1.60), and 1.87 (1.34–2.63), respectively (
p
-trend = 0.0003). Systolic blood pressure and serum glucose were associated with an increased risk of death from total cancer [HR (95% CI) for highest vs. lowest quartiles: 1.67 (1.19–2.33),
p
-trend = 0.002 and 1.34 (1.04–1.74),
p
-trend = 0.003, respectively]. Overall null results were obtained for lung cancer mortality. The effects of metabolic syndrome and its components on non-lung cancer mortality were generally similar to, but somewhat larger than, those for total cancer mortality.
Conclusion
Our study is among the first to reveal that metabolic syndrome is associated with increased total cancer mortality.
Journal Article
Agreement between older adult patient and caregiver proxy symptom reports
2022
Background
Proxy report is essential for patients unable to complete patient-reported outcome (PRO) measures themselves and potentially beneficial when the caregiver perspective can complement patient report. In this study, we examine agreement between self-report by older adults and proxy report by their caregivers when completing PROs for pain, anxiety, depression, and other symptoms/impairments.
Methods
Four PROs were administered by telephone to older adults and their caregivers followed by re-administration within 24 h in a random subgroup. The PROs included the PHQ-9 depression, GAD-7 anxiety, PEG pain, and SymTrak multi-dimensional symptom and functional status scales.
Results
The sample consisted of 576 older adult and caregiver participants (188 patient-caregiver dyads, 200 patients without identified caregiver). The four measures had good internal (Cronbach’s alpha, 0.76 to 0.92) and test–retest (ICC, 0.63 to 0.92) reliability whether completed by patients or caregivers. Total score and item-level means were relatively similar for both patient and caregiver reports. Agreement for total score as measured by intraclass correlation coefficient (ICC) was better for SymTrak-23 (0.48) and pain (0.58) than for anxiety (0.28) and depression (0.25). Multinomial modeling showed higher (worse) patient-reported scale scores were associated with caregiver underreporting, whereas higher caregiver task difficulty was associated with overreporting.
Conclusion
When averaged over individuals at the group level, proxy reports of PRO scores by caregivers tend to approximate patient reports. For individual patients, proxy report should be interpreted more cautiously for psychological symptoms as well as when patient-reported symptoms are more severe, or caregiver task difficulty is high.
Plain English summary
Assessment of patient-reported outcomes (e.g., symptoms, functional status, and other quality of life domains) by a proxy on behalf of the patient is helpful when patient self-report is not possible or when a complementary perspective may inform care. Determining how well older adult patients and their caregivers agree on the patient’s pain, depression, anxiety, and functioning is important in investigating and managing these core clinical domains. In this study, patient-caregiver agreement was evaluated for four commonly-used scales that assess depression (PHQ-9), anxiety (GAD-7), pain (PEG), and multi-dimensional symptom and functional impairment (SymTrak). Total score and item-level scores were similar between patients and caregivers when averaged at the group level. Agreement was higher for more physically oriented domains (pain and SymTrak) than psychological conditions (depression and anxiety). Higher (worse) patient-reported scale scores were associated with caregiver underreporting, whereas higher caregiver task difficulty was associated with overreporting. Proxy report may be sufficiently accurate in research when studying group differences. However, proxy reports should be interpreted more cautiously in individual patients with psychological symptoms or higher symptom severity, or where there is caregiver diffficulty.
Journal Article
Leveraging social media to increase lung cancer screening awareness, knowledge and uptake among high-risk populations (The INSPIRE-Lung Study): study protocol of design and methods of a community-based randomized controlled trial
by
Rawl, Susan M.
,
Valenzona, Francis
,
Carter-Bawa, Lisa
in
Biostatistics
,
Cancer
,
Cancer screening
2023
Background
Lung cancer is the leading cause of cancer death for both men and women in the United States. The National Lung Screening Trial (NLST) demonstrated that low-dose computed tomography (LDCT) screening can reduce lung cancer mortality among high-risk individuals, but uptake of lung screening remains low. Social media platforms have the potential to reach a large number of people, including those who are at high risk for lung cancer but who may not be aware of or have access to lung screening.
Methods
This paper discusses the protocol for a randomized controlled trial (RCT) that leverages FBTA to reach screening-eligible individuals in the community at large and intervene with a public-facing, tailored health communication intervention (
LungTalk
) to increase awareness of, and knowledge about, lung screening.
Discussion
This study will provide important information to inform the ability to refine implementation processes for national population efforts to scale a public-facing health communication focused intervention using social media to increase screening uptake of appropriate, high-risk individuals.
Trial registration
The trial is registered at clinicaltrials.gov (#NCT05824273).
Journal Article
Pragmatic trial of a virtual dementia collaborative care management program: protocol for the Aging Brain Care Virtual (ABCV) program
by
Sauerteig-Rolston, Madison R
,
Boustani, Malaz
,
Slaven, James
in
Aged
,
Aging
,
Alzheimer's disease
2025
IntroductionProviding care management, treatment and support to patients with Alzheimer’s Disease and Related Dementias (ADRD) is a difficult task for health systems. Over the past 20 years, interventions designed to improve outcomes for patients living in the community with dementia and their care partners have moved progressively, but separately, from large scale trials and pragmatic models of collaborative care. Given the projected increase in the number of people living with dementia coupled with the realignment of payment for services to be value-based and provided in the community, system-level approaches are needed to address the complex needs of patients with a dementia diagnosis and their care partners. We designed a statewide, pragmatic trial to evaluate virtual delivery of an evidence-based dementia collaborative care program on patient healthcare utilization and medication use.Methods and analysisThe Aging Brain Care Virtual (ABCV) program is a 12-month embedded, cluster randomized, usual care controlled trial designed to test the effectiveness of a virtual dementia collaborative care program in 24 Indiana University Health primary care clinics (12 intervention, 12 control) across the state of Indiana, enrolling 860 persons living with dementia (430 intervention, 430 control) and their care partners. ABCV relies on a tailored approach in which dyad needs are identified during virtual visits and addressed with standardized protocols previously tested in a randomized controlled trial delivered in person. The ABCV trial will measure emergency department utilization (primary outcome) and appropriate medication use (secondary outcome) at 12 months using electronic medical record data. Additionally, this study will use semi-structured interviews with care partners and clinicians to explore the implementation context, process and outcomes of the ABCV program.Ethics and disseminationEthics approval was obtained from the Indiana University Institutional Review Board (20249). Research findings will be published in peer-reviewed journals and presented at scientific conferences.Trial registration numberNCT06245499.
Journal Article
Communication Quality Predicts Psychological Well-Being and Satisfaction in Family Surrogates of Hospitalized Older Adults: An Observational Study
2018
BackgroundMany hospitalized older adults require family surrogates to make decisions, but surrogates may perceive that the quality of medical decisions is low and may have poor psychological outcomes after the patient’s hospitalization.ObjectiveTo determine the relationship between communication quality and high-quality medical decisions, psychological well-being, and satisfaction for surrogates of hospitalized older adults.DesignObservational study at three hospitals in a Midwest metropolitan area.ParticipantsHospitalized older adults (65+ years) admitted to medicine and medical intensive care units who were unable to make medical decisions, and their family surrogates. Among 799 eligible dyads, 364 (45.6%) completed the study.Main MeasuresCommunication was assessed during hospitalization using the information and emotional support subscales of the Family Inpatient Communication Survey. Decision quality was assessed with the Decisional Conflict Scale. Outcomes assessed at baseline and 4–6 weeks post-discharge included anxiety (Generalized Anxiety Disorder-7), depression (Patient Health Questionnaire-9), post-traumatic stress (Impact of Event Scale-Revised), and satisfaction (Hospital Consumer Assessment of Healthcare Providers and Systems).Key ResultsThe mean patient age was 81.9 years (SD 8.32); 62% were women, and 28% African American. Among surrogates, 67% were adult children. Six to eight weeks post-discharge, 22.6% of surrogates reported anxiety (11.3% moderate–severe anxiety); 29% reported depression, (14.0% moderate–severe), and 14.6% had high levels of post-traumatic stress. Emotional support was associated with lower odds of anxiety (adjusted odds ratio [AOR] = 0.65, 95% CI 0.50, 0.85) and depression (AOR = 0.80, 95% CI 0.65, 0.99) at follow-up. In multivariable linear regression, emotional support was associated with lower post-traumatic stress (β = −0.30, p = 0.003) and higher decision quality (β = −0.44, p < 0.0001). Information was associated with higher post-traumatic stress (β = 0.23, p = 0.022) but also higher satisfaction (β = 0.61, p < 0.001).ConclusionsEmotional support of hospital surrogates is consistently associated with better psychological outcomes and decision quality, suggesting an opportunity to improve decision making and well-being.
Journal Article
Planning Ahead: protocol for a randomised trial of advance care planning for community dwelling older adults at increased mortality risk
by
Cavanaugh, Melissa
,
Montgomery, Carole
,
Slaven, James
in
Adult palliative care
,
Advance Care Planning
,
Advance directives
2025
IntroductionAn important goal of advance care planning (ACP) is ensuring that patients receive care concordant with their preferences. High-quality evidence is needed about the effect of ACP on this and other outcomes.Methods and analysisPlanning Ahead is a randomised controlled trial to test the effectiveness of facilitated ACP in community-dwelling older adults including those with normal cognition and those with Alzheimer’s Disease and Related Dementias (ADRD) who are at high risk of death. The primary aim is to determine the effect of the intervention on discordance between preferences for medical treatments and the treatments received in the year after the intervention. Secondary outcomes include decision-making quality, care at the end of life and cost. Eligible patients have a primary care provider at one of two Midwest health systems, have an approximate 33% mortality risk and do not have a POLST form at baseline. Patients with capacity can invite the person they would choose to be their healthcare decision maker to participate as a study partner. A surrogate decision maker enrols and receives the intervention for patients who lack capacity due to ADRD. The intervention uses the Respecting Choices Advanced Steps (RCAS) model of ACP delivered by a registered nurse and includes identification of the patient’s values and goals, education about ACP and the POLST form and the opportunity to complete a POLST form.Ethics and disseminationThe study is approved by the Indiana University Institutional Review Board. Primary and secondary analyses will be published in peer-reviewed journals. We also plan dissemination through the media. We will construct a deidentified data set that could be available to other researchers. Survey data will be preserved and shared via the NIH-supported National Archive of Computerised Data on Ageing’s (NACDA) Open Ageing Repository (OAR).Trial registration numberNCT04070183.
Journal Article
Pragmatic characteristics of patient-reported outcome measures are important for use in clinical practice
by
Monahan, Patrick O.
,
Kean, Jacob
,
Kroenke, Kurt
in
Biomedical research
,
Clinical medicine
,
Epidemiology
2015
Measures for assessing patient-reported outcomes (PROs) that may have initially been developed for research are increasingly being recommended for use in clinical practice as well. Although psychometric rigor is essential, this article focuses on pragmatic characteristics of PROs that may enhance uptake into clinical practice.
Three sources were drawn on in identifying pragmatic criteria for PROs: (1) selected literature review including recommendations by other expert groups; (2) key features of several model public domain PROs; and (3) the authors' experience in developing practical PROs.
Eight characteristics of a practical PRO include: (1) actionability (i.e., scores guide diagnostic or therapeutic actions/decision making); (2) appropriateness for the relevant clinical setting; (3) universality (i.e., for screening, severity assessment, and monitoring across multiple conditions); (4) self-administration; (5) item features (number of items and bundling issues); (6) response options (option number and dimensions, uniform vs. varying options, time frame, intervals between options); (7) scoring (simplicity and interpretability); and (8) accessibility (nonproprietary, downloadable, available in different languages and for vulnerable groups, and incorporated into electronic health records).
Balancing psychometric and pragmatic factors in the development of PROs is important for accelerating the incorporation of PROs into clinical practice.
Journal Article
Prevalence and risk factors for ototoxicity after cisplatin-based chemotherapy
by
Fung, Chunkit
,
Travis, Lois B.
,
Rooker, Jennessa
in
Antineoplastic Agents - adverse effects
,
Cancer
,
Cancer Survivors
2023
Purpose
Ototoxicity is a prominent side effect of cisplatin-based chemotherapy. There are few reports, however, estimating its prevalence in well-defined cohorts and associated risk factors.
Methods
Testicular cancer (TC) survivors given first-line cisplatin-based chemotherapy completed validated questionnaires. Descriptive statistics evaluated the prevalence of ototoxicity, defined as self-reported hearing loss and/or tinnitus. We compared patients with and without tinnitus or hearing loss using Chi-square test, two-sided Fisher’s exact test, or two-sided Wilcoxon rank sum test. To evaluate ototoxicity risk factors, a backward selection logistic regression procedure was performed.
Results
Of 145 TC survivors, 74% reported ototoxicity: 68% tinnitus; 59% hearing loss; and 52% reported both. TC survivors with tinnitus were more likely to indicate hypercholesterolemia (
P
= 0.008), and difficulty hearing (
P
< .001). Tinnitus was also significantly related to age at survey completion (OR = 1.79;
P
= 0.003) and cumulative cisplatin dose (OR = 5.17;
P
< 0.001). TC survivors with hearing loss were more likely to report diabetes (
P
= 0.042), hypertension (
P
= 0.007), hypercholesterolemia (
P
< 0.001), and family history of hearing loss (
P
= 0.044). Risk factors for hearing loss included age at survey completion (OR = 1.57;
P
= 0.036), hypercholesterolemia (OR = 3.45;
P
= 0.007), cumulative cisplatin dose (OR = 1.94;
P
= 0.049), and family history of hearing loss (OR = 2.87;
P
= 0.071).
Conclusions
Ototoxicity risk factors included age, cisplatin dose, cardiovascular risk factors, and family history of hearing loss. Three of four TC survivors report some type of ototoxicity; thus, follow-up of cisplatin-treated survivors should include routine assessment for ototoxicity with provision of indicated treatments.
Implications for Cancer Survivors
Survivors should be aware of risk factors associated with ototoxicity. Referrals to audiologists before, during, and after cisplatin treatment is recommended.
Journal Article