Psychometric validation and interpretation of the Nocturia Impact Diary in a clinical trial setting

Purpose Psychometric evaluation of the Nocturia Impact (NI) Diary was conducted to support its use as a trial endpoint. Methods As part of a randomized, controlled Phase 2 clinical trial investigating a novel drug candidate for nocturnal polyuria, adult nocturia patients completed the NI Diary and a voiding diary for three nights preceding their clinic visit at Baseline and Weeks 1, 4, 8, and 12 (end of treatment). Exit interviews were conducted to obtain patient impressions of the NI Diary. Results A total of N = 302 participants were included. Confirmatory factor analysis (CFA) indicated that the 11-item measure is unidimensional with values of CFI, TLI, and RMSEA meeting relevant thresholds. Good internal consistency (Cronbach’s α 0.941) and test–retest reliability (intra-class correlation coefficients 0.730–0.880). Convergent validity with two reference measures was demonstrated with strong correlations of 0.573–0.730 were shown. Significant differences (P = 0.0018, standardized effect size = 0.372) between groups defined by number of night-time voids supported known-groups validity. Exit interviews in 66 patients indicated all participants experienced improvement in at least 1 NI Diary item and that a 1-point improvement on the item response scale and 1-void reduction per night (associated with an average best cut point on ROC analysis of − 11.6) constituted meaningful improvement. Anchor and distribution-based analyses identified a meaningful change threshold of − 15 to − 18 points on the NI Diary. Conclusion The NI Diary is a reliable and valid patient-reported psychometric instrument which is fit-for-purpose to evaluate the impact of nocturia on patient quality of life in the clinical trial setting. Trial registration number and registration date NCT03201419; June 28, 2017.

Effects of adjunctive brexpiprazole on calmness and life engagement in major depressive disorder: post hoc analysis of patient-reported outcomes from clinical trial exit interviews

Background Though often overlooked, calming patients and increasing their life engagement are key factors in the treatment of major depressive disorder (MDD). This study aimed to test the hypothesis that adjunctive brexpiprazole increases calmness and life engagement among patients with MDD, based on clinical trial exit interviews. Methods This was a pooled analysis of exit interview data from three exploratory, open-label studies of adjunctive brexpiprazole 1–3 mg/day. The studies enrolled 105 outpatients with MDD (DSM-IV-TR criteria), a current depressive episode, and inadequate response to antidepressant treatment during the current episode. Patients were interviewed if they completed the end-of-treatment visit (Week 6 or Week 12, depending on the study). Exit interviews took the form of semi-structured telephone interviews in which patients were asked mostly qualitative questions about their symptoms prior to the start of the study, and about improvements they had noted during treatment. Interview transcripts were reviewed and codes were assigned to calmness and life engagement vocabulary, allowing aggregation of the frequency of improvement in various domains. Results 79.8% (83/104) of patients described improvements consistent with at least one calmness term, most commonly feeling less anxious (46.2%) or less irritable (44.2%). A four-domain concept of patient life engagement was developed in which 88.6% (93/105) of patients described improvements consistent with at least one domain, specifically, emotional (77.1%), physical (75.2%), social (41.9%), and/or cognitive (36.2%). Of the patients who described improvement in calmness, 96.4% (80/83) also described improvement in life engagement. Conclusions Analysis of exit interview data suggests that patients were calmer and more engaged with life following treatment with adjunctive brexpiprazole. Thus, adjunctive brexpiprazole may provide a benefit on subjective patient outcomes in addition to the improvement in depressive symptoms shown by clinical rating scale data. Trial Registration: Data used in this post hoc analysis came from ClinicalTrials.gov identifiers: NCT02012218, NCT02013531, NCT02013609.

Psychometric validation and meaningful change thresholds of the Worst Itching Intensity Numerical Rating Scale for assessing itch in patients with chronic kidney disease-associated pruritus

Background Chronic kidney disease-associated pruritus (CKD-aP) is characterized by persistent itch that often leads to substantially impaired quality of life. The Worst Itching Intensity Numerical Rating Scale (WI-NRS) is a single-item patient-reported outcome measure in which patients indicate the intensity of the worst itching they experienced over the past 24 h. Here, we evaluated the content validity and psychometric properties of the WI-NRS and confirmed the threshold of meaningful change in hemodialysis patients with moderate-to-severe CKD-aP. Methods Content validity interviews were conducted in 23 patients. Psychometric properties of the WI-NRS were assessed using data from one phase 2 (N = 174) and two phase 3 (N = 848) clinical trials investigating an anti-pruritic treatment. Anchor-based methods were used to confirm meaningful within-patient change score thresholds in the phase 3 trial patients and mixed-method exit interviews (N = 70) contributed further insight. Results Content validity interviews indicated patients considered the WI-NRS to be straightforward, comprehensive, and relevant. Test–retest reliability was strong in both trial cohorts (intraclass correlation coefficients > 0.75). Construct validity analyses indicated high correlation between the WI-NRS and other measures of itch. Anchor-based analyses showed a reduction of ≥ 3 points from baseline score represented an appropriate clinically meaningful within-patient change on the WI-NRS. In the exit interviews, all patients with a reduction ≥ 3 points considered the change meaningful. Conclusions The WI-NRS is a reliable, valid, and responsive measure of itch intensity for patients with moderate-to-severe CKD-aP. These results support its use to assess treatment efficacy and in clinical evaluation and management of pruritus in hemodialysis patients.

Characterizing Nonreturning College Students and Their Departure Intentions

Success for 4-year universities is often measured by graduation and retention rates; however, gaps exist in understanding nonreturning students at private institutions. Recent research is helping to build the lexicon of drop-outs, stop-outs, opt-outs, and transfer-outs to inform strategic retention initiatives. Using an action research method, we characterized 1,091 students into designated subclasses and utilized exit interviews, advising notes, and university surveys to theme their departure intentions. Findings reveal transfer-outs to be the largest subclass, with departure reasons being summarized within themes of university experience and fit, health, academic, and financial. Recommendations are made for university administrators and retention offices related to exit survey questions, broadening success metrics, and to focus on specific student characteristic groups.

ViewpointExploring leadership through literature - an audacious experiment

PurposeThe purpose of the paper is to address the following question: What can novels reveal about what leadership nonfiction sources miss or obscure?Design/methodology/approachThe paper reviews the benefits that are derived from the use of literature in the examination of leadership, compares and contrasts three novel experiments in the examination of literature and leadership, and examines the impact of one approach as reflected in student assignments and exit interviews.FindingsStudent reflection papers morphed from descriptive reviews to reflections expressed through poetry, artwork and personal experiences. Students also deepened their views on what leadership is and means. Exit interviews revealed student significant reflection on personal views in a number of areas. The longitudinal follow up of students expanded their flexibility and ability to listen and understand how and why people approach leadership in different ways. They also felt it increased their openness to new or different approaches and encouraged them to think more independently.Practical implicationsOne implication of the approach of this class is how the authors embraced questions to guide the students and faculty. Instead of listing topics and assigning categorical meaning, the approach of the class was organized around questions, such as, “is leadership real or imagined? Am I ready to take responsibility?Social implicationsThe power of storytelling is unmistakable. The value of storytelling is that it allows the reader to escape from the day-to-day challenges we face to find how others are facing challenges sometimes very similar to our own.Originality/valueThe article compares and contracts three experiments in the examination of literature and leadership. The paper then examines one approach to literature and leadership in terms of the impact on students (papers, exit interview and longitudinal follow-up). Findings are assessed with the works of Gardner, Bennis and Hartley stressing the possibilities of storytelling as a unique approach to studying and practicing leadership.

Virtual Mind-Body Program for Obese Knee Osteoarthritis Patients with Comorbid Depression: Development and Feasibility Pilot (Preprint)

BACKGROUND Knee osteoarthritis (KOA) is the most common joint disorder in the U.S. and a leading cause of disability. Depression and obesity are highly comorbid with KOA and accelerate knee degeneration and disability through biopsychosocial mechanisms. Mind-body physical activity programs can engage biological, mechanical, and psychological mechanisms to improve outcomes in KOA, but such programs are not currently available. OBJECTIVE Here, we report on a mixed-methods study to adapt a mind-body activity program for the unique needs of patients with KOA, depression, and obesity (GetActive-OA) delivered via live video. METHODS Participants were adults (age ≥ 45) from rural Kentucky with obesity (BMI ≥ 30 kg/m2), idiopathic KOA with mild to moderate radiographic changes, and elevated depressive symptoms (PHQ-9 ≥ 10) recruited from two orthopedic centers. In Phase 1, we developed GetActive-OA and the study protocol using qualitative focus group feedback from the study population (N = 9; 2 focus groups, 90 minutes) and multidisciplinary expertise from clinical psychologists and orthopedic researchers. In Phase 2, we explored the initial feasibility, credibility, and acceptability of GetActive-OA, live video delivery, and study procedures via an open pilot with exit interviews (N = 5, 1 group). This research was guided by the NIH Model Stage 1A. RESULTS Phase 1 qualitative analyses revealed nuanced information about: 1) challenges with coping and increasing activity, 2) high interest in a mind-body activity program, 3) program participation facilitators (flexibility with technology) and barriers (amotivation, forgetfulness), and 4) perceived challenges with data collection procedures (blood and urine samples, homework). Phase 2 quantitative analyses showed that GetActive-OA met most a priori feasibility markers (e.g., feasibility of recruitment, acceptability, expectancy, credibility, adherence, and program satisfaction). Adherence to ActiGraph wear and collection of blood samples was low. Participation in GetActive-OA was associated with signals of improvements in pain, KOA symptoms, depression, anxiety, pain catastrophizing, self-efficacy, and general coping. Qualitative exit interviews confirmed quantitative findings and provided valuable information to optimize the program and protocol. CONCLUSIONS Patients with KOA, depression, and obesity from rural Kentucky are interested in a virtual mind-body activity program this comorbidity GetActive-OA shows promise, but the program and protocol require further NIH stage 1 refinement before formal efficacy testing (NIH model stage II). INTERNATIONAL REGISTERED REPORT RR2-10.1016/j.conctc.2021.100720

An eHealth Intervention for Promoting COVID-19 Knowledge and Protective Behaviors and Reducing Pandemic Distress among Sexual and Gender Minorities: Protocol for a Randomized Controlled Trial (#SafeHandsSafeHearts) (Preprint)

BACKGROUND Existing data on COVID-19 disparities among vulnerable populations portend excess risk for lesbian, gay, bisexual, transgender (LGBT) and other persons outside of heteronormative and cisgender identities (i.e., LGBT+). Owing to adverse social determinants of health, including pervasive HIV and sexual stigma, harassment, violence, barriers in access to healthcare, and existing health and mental health disparities, sexual and gender minorities in India and Thailand are at disproportionate risk for SARS-CoV-2 infection and severe disease. Despite global health disparities among LGBT+ populations, there is a lack of coordinated, community-engaged interventions to address the expectable excess burden of COVID-19 and public health-recommended protective measures. OBJECTIVE We will conduct a randomized controlled trial (RCT) to evaluate the effectiveness of a brief, peer-delivered eHealth intervention to increase COVID-19 knowledge and public health-recommended protective behaviors and reduce psychological distress among LGBT+ people residing in Bangkok, Thailand, and Mumbai, India. Subsequent to the RCT, we will conduct exit interviews with purposively sampled subgroups, including those with no intervention effect. METHODS SafeHandsSafeHearts is a 2-site, parallel waitlist-controlled RCT to test the efficacy of a 3-session, peer counselor-delivered eHealth intervention based on motivational interviewing and psychoeducation. The study methods, online infrastructure and content were pilot tested with LGBT+ individuals in Toronto, Canada before adaptation and roll-out in the other contexts. The primary outcomes are COVID-19 knowledge (index based on U.S. CDC items), protective behaviors (index based on WHO and U.S. CDC guidelines), depression (PHQ-2) and anxiety (GAD-2). Secondary outcomes include loneliness, COVID-19 stress, and intended care-seeking. We will enroll N = 310 participants in each city, age 18 years and older, one-third cisgender gay, bisexual and other men who have sex with men, one-third cisgender lesbian, bisexual and other women who have sex with women, and one-third transfeminine, transmasculine and gender nonbinary people. Participants will be equally stratified in the immediate intervention and waitlist control group. Participants are mainly recruited from online social media accounts of community-based partner organizations. They can access the intervention on a computer, tablet, or mobile phone. SafeHandsSafeHearts has 3 sessions delivered weekly over three successive weeks. Exit interviews will be conducted online with 3 subgroups (n = 12 per group; N = 36 in each city) of purposively selected participants, to be informed by RCT outcomes and focal populations of concern. RESULTS The RCT was funded in 2020. The study protocol was registered with ClinicalTrials.gov (NCT04870723). The trials started recruitment as of August 1, 2021, and all RCT data collection will likely be completed by December 31, 2021. CONCLUSIONS The SafeHandsSafeHearts RCT will provide evidence about the effectiveness of a brief, peer-delivered e-Health intervention developed for LGBT+ populations amid the COVID-19 pandemic. If the intervention proves effective, it will provide a basis for future scale-up in India and Thailand, and other low- and middle-income countries. CLINICALTRIAL NIH U.S. National Library of Medicine, ClinicalTrials.gov: NCT04870723; https://clinicaltrials.gov/ct2/show/NCT04870723

Using Qualitative Methods

Qualitative methods can provide quick insights and information that can help to improve delivery, access, quality and coverage of health services and programmes. These methods ask questions and make observations that can complement quantitative information from routine information systems, health surveys, and quantitative studies. These quick methods help to understand people’s beliefs and why they make use and do not make use of local health services and programmes. The main methods include record reviews, observations, exit interviews, key informant interviews, focus groups, and rural appraisal. Importance of triangulation is explained.

Physiological and Behavioral Benefits for People and Horses during Guided Interactions at an Assisted Living Residence

Assisted living is a fast-growing living option for seniors who require residence-based activities for maintaining mental and physical health. Guided equine interactions may benefit seniors, so an on-site equine program was started at Hacienda at the River senior living community. For research purposes, twenty-four residents and associates, aged fifty-five or over, consented to physiological measurements before, during and after four guided sessions of stroking one of three horses for 10 min over 4–6 weeks. Heart rate variability (HRV) was measured simultaneously in humans and horses during interactions. We hypothesized that human heart rate (HR) and HRV would increase during stroking and HRV power would shift toward the very low frequency (VLF) range common in horses, indicative of healthy function. During stroking, human HR increased (p < 0.05) but HRV (SDRR) and %VLF of HRV power did not change. Diastolic blood pressure (DBP), an exploratory measure, significantly increased after stroking, consistent with arousal. Two horses showed no significant changes in HR or HRV, but one relaxed. Sixteen horse–human pairs demonstrated synchronized HRV peak frequencies during sessions, suggestive of social connection. Participants used more positive than negative words describing their experience during exit interviews (p < 0.05). These data show that horses animate seniors without causing emotional stress and provide opportunities for social bonding.

Feasibility randomized controlled trial of a mind-body activity program for older adults with chronic pain and cognitive decline: The virtual “Active Brains” study

Background and Objectives Chronic pain (CP) and cognitive decline (CD) are highly co-morbid and debilitating among older adults. We iteratively developed Active Brains–Fitbit (AB-F), a group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in physical, cognitive, and emotional functioning when delivered in person to older adults with CP and CD. We adapted our intervention and methodology for remote delivery to bypass barriers to participation. Here we report on a feasibility randomized controlled trial of the virtual AB-F versus a Health Enhancement Program (HEP) educational control followed by qualitative exit interviews. Research Design and Methods Older adults (age ≥ 60) with CP and CD (2 cohorts) completed eight weeks of AB-F (n = 8) or HEP (n = 11). Study procedures were fully remote via live video. Quantitative analyses explored feasibility and acceptability markers and within group improvements in outcomes. Qualitative analyses were primarily deductive using the Framework Method. Results AB-F met a-priori set feasibility benchmarks, similar to our in-person pilot. Participation in AB-F was associated with preliminary signals of improvement in multimodal physical function, emotional function (anxiety), cognitive function, pain intensity, and coping (e.g., pain self-efficacy, catastrophizing). Participation in HEP was associated with smaller or negligible improvements. Exit interviews confirmed feasibility and satisfaction with our completely remote interventions and methodology. Discussion and Implications Results provide evidence for the feasibility of our completely remote study, and for initial markers of improvement after AB-F. The results will inform a fully powered remote efficacy trial.