Background Social determinants of health (SDOH) complicate medical care and affect clinical outcomes, but the lack of a reliable structured interview for medical patients has impeded clinical assessment and research on SDOH. We assessed the reliability and validity of a newly developed SDOH Patient Interview Form and investigated SDOH in patients with heart failure. Methods The SDOH Patient Interview Form was administered to recently hospitalized patients with heart failure between January 2021 and April 2024. The interviews were recorded, and 50 were randomly selected for the interrater reliability analysis. Results The sample included 367 participants (mean age, 61.2±12.1 years; 42.5% women; 57.7% minorities). The interrater reliability of SDOH Patient Interview Form categories (eg, Legal and Social Problems) was 100%. The κ reliability coefficients for individual items were ≥0.94. Higher lifetime SDOH counts were associated with lower age and income and higher New York Heart Association class and body mass index. Two distinct sets of problems were found to contribute to relatively high burdens of SDOH. The first originates with abuse in childhood and presents as severe socioeconomic deprivation in adulthood. The second includes losses of family members and occupational, financial, and caregiver stress along with difficulty affording medical care. Conclusions The SDOH Patient Interview Form is a reliable instrument for assessing patient‐reported SDOH in patients with heart failure. It is suitable for use in research and clinical contexts but requires further testing in other medical patient populations. This study revealed 2 distinct patterns of stressful problems that can contribute to a high overall burden of SDOH. Registration URL: https://clinicaltrials.gov; Unique identifier: NCT04637776.

Objective There have been numerous studies of specific psychiatric comorbidities such as major depression in patients with heart disease, but there have been relatively few studies of psychiatric multimorbidity in these patients. The purpose of this cross-sectional study was to investigate the prevalence and correlates of psychiatric multimorbidity in patients with heart failure (HF). Methods Patients who had been hospitalized with HF were enrolled in this cross-sectional study within 30 days of hospital discharge and interviewed within two weeks after enrollment. Participants completed the NetSCID-5 diagnostic interview, a social determinants of health (SDOH) interview, and perceived stress and health-related quality of life questionnaires. Results A total of 362 patients completed the interview. The maximum possible lifetime comorbidity count was 11 but the observed maximum was 8; the mean (SD) count was 1.48 (1.63). A total of 135 (37 %) patients had no history of any psychiatric disorder, 97 (27 %) had a lifetime history of a single disorder, and 130 (36 %) had ≥2 lifetime disorders. Higher numbers of psychiatric disorders were associated with younger age, more exposure to SDOH, higher perceived stress, and chronic obstructive pulmonary disease. Conclusion Psychiatric multimorbidity is prevalent in patients with HF and is associated with worse medical and social health status. New studies of the consequences or treatment of specific psychiatric comorbidities in patients with heart disease should take psychiatric multimorbidity into account, and further research on psychiatric multimorbidity per se is needed.

Pilot trials have a key role in preparing for definitive randomized trials, yet determining their sample size remains a common challenge. This article provides practical guidance, methods, and tools-including step-by-step examples, sample size tables, and statistical code-for calculating and justifying sample sizes in external randomized pilot trials.

ObjectiveAs multiple sophisticated techniques are used to evaluate psychometric scales, in theory reducing error and enhancing measurement of patient reported outcomes, we aimed to determine whether applying different psychometric analyses would demonstrate important differences in treatment effects.Study Design and SettingWe conducted secondary analysis of individual participant data from 20 antidepressant treatment trials obtained from Vivli.org (n=6,843). Pooled item-level data from the HRSD-17 were analysed using confirmatory factory analysis (CFA), item response theory (IRT) and network analysis (NA). Multilevel models were used to analyse differences in trial effects at approximately 8 weeks (range 4-12 weeks) post-treatment commencement, with standardised mean differences calculated as Cohen’s d. Effect size outcomes for the original total depression scores were compared with psychometrically-informed outcomes based on abbreviated and weighted depression scores. ResultsSeveral items performing poorly during psychometric analyses and were eliminated, resulting in different models being obtained for each approach. Treatment effects were modified as follows per psychometric approach: 10.4%-14.9% increase for CFA, 0%-2.9% increase for IRT, 14.9%-16.4% reduction for NA. ConclusionPsychometric analyses differentially moderate effect size outcomes depending on the method used. In a 20-trial sample, factor analytic approaches increased treatment effect sizes relative to the original outcomes, NA decreased them, and IRT results reflected original trial outcomes.

BACKGROUND:Posttraumatic stress disorder (PTSD) is associated with risk for cardiovascular disease (CVD). Improved physical health often follows large decreases in PTSD severity, but it is not known if better CVD outcomes follow PTSD improvement in patients with comorbid PTSD and CVD. METHODS:De-identified medical record data between 2011 and 2022 was used to create a cohort of 7120 Veterans Health Administration patients with PTSD and comorbid CVD. The exposure was clinically meaningful PTSD improvement defined as ≥20-point PTSD Checklist (PCL) decrease. Entropy balance controlled for confounding. Cox proportional hazard models estimated the association between clinically meaningful PCL decrease and CVD outcomes: myocardial infarction or revascularization procedure, all-cause mortality, and stroke. RESULTS:About half (52.2 %) of the sample was 65-80 years of age, 95.5 % were male, 17.3 % identified as Black and 79.2 % as White race. Clinically meaningful PTSD improvement occurred for 20.4 % of patients. After controlling for confounding, those with vs. without clinically meaningful PTSD improvement did not significantly differ on risk for myocardial infarction or revascularization procedure (HR = 1.07; 95 %CI:0.94-1.20), all-cause mortality (HR = 1.02; 95 %CI:0.89-1.17), and stroke (HR = 1.10; 95 %CI:0.96-1.26). Neither race, age nor depression significantly modified the association of PTSD improvement and risk for adverse CVD outcomes. CONCLUSIONS:In this sample of veterans, large reductions in PTSD severity were not associated with better or worse CVD outcomes. Research is needed to determine if clinically meaningful PTSD improvement and the lack of association with CVD outcomes is seen in other populations of patients with comorbid PTSD and CVD.

BACKGROUND:Psychometric methods are used to remove underperforming items and reduce error in existing measures, albeit different approaches can produce different results. This study aimed to determine the implications of applying different psychometric methods for clinical trial outcomes. METHODS:Individual participant data from 15 antidepressant treatment trials from Vivli.org were analyzed. Baseline (pretreatment) and 8-week (range 4-12 weeks) outcome data from the Montgomery-Asberg Depression Rating Scale were subjected to best-practice factor analysis (FA), item response theory (IRT), and network analysis (NA) approaches. Trial outcomes for the original summative scores and psychometric-model scores were assessed using multilevel models. Percentage differences in Cohen's d effect sizes for the original summative and psychometrically modeled scores were the effects of interest. RESULTS:Each method produced unidimensional models, but the modified scales varied from 7 to 10 items. Treatment effects (d = 0.072) were unchanged for IRT (10 items), decreased by 1.3%-2.8% (eight-item abbreviated d = 0.070; weighted score d = 0.071) for NA, and increased by 11%-12.5% (seven-item abbreviated model d = 0.081; weighted score d = 0.080) for FA. DISCUSSION:IRT and NA yielded negligible differences in effect outcomes relative to original trials. FA increased effect sizes and may be the most effective method for identifying the items on which placebo and treatment group outcomes differ.

Objective: The aim of this study was to identify for the first time patterns of self-care decision-making (i.e. the extent to which participants viewed contextual factors influencing decisions about symptoms) and associated factors among community-dwelling adults with chronic illness.Methods: This was a secondary analysis of data collected during the development and psychometric evaluation of the 27-item Self-Care Decisions Inventory that is based on Naturalistic Decision-Making (n = 430, average age = 54.9 +/- 16.2 years, 70.2 % female, 87.0 % Caucasian, average number of chronic conditions = 3.6 +/- 2.8). Latent class mixture modeling was used to identify patterns among contextual factors that influence self-care decision-making under the domains of external, urgency, uncertainty, cognitive/affective, waiting/cue competition, and concealment. Multivariate multinomial regression was used to identify additional socio-demographic, clinical, and self-care behavior factors that were different across the patterns of self-care decision-making.Results: Three patterns of self-care decision-making were identified in a cohort of 430 adults. A 'maintainers' pattern (48.1 %) consisted of adults with limited contextual influences on self-care decision-making except for urgency. A 'highly uncertain' pattern (23.0 %) consisted of adults whose self-care decision-making was largely driven by uncertainty about the cause or meaning of the symptom. A 'distressed concealers' pattern (28.8 %) consisted of adults whose self-care decision-making was highly influenced by external factors, cognitive/affective factors and concealment. Age, education, financial security and specific symptoms were significantly different across the three patterns in multivariate models.Conclusion: Adults living with chronic illness vary in the extent to which contextual factors influence decisions they make about symptoms, and would therefore benefit from different interventions. (c) 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

BACKGROUND:The 10-item Montgomery-Åsberg Depression Rating Scale (MADRS) is a commonly used measure of depression in antidepressant clinical trials. Numerous studies have adopted classical test theory perspectives to assess the psychometric properties of this scale, finding generally positive results. However, its network configural structure and stability is unexplored across different time-points and treatment groups. AIMS:To assess the network structure and stability of the MADRS in clinical settings pre- and post-treatment, and to determine a configurally invariant and stable model across time-points and treatment groups (placebo and intervention). METHOD:Individual participant data for 6440 participants from 14 clinical trials of major depressive disorder was obtained from the data repository Vivli.org. Exploratory Graphical Analysis (EGA) was used to identify empirical models pre-treatment (baseline) and post-treatment (8-week outcome). Bootstrapping techniques were applied to obtain optimised configurally invariant models. RESULTS:Empirical models presented with performance issues at baseline and for the placebo group at outcome. An abbreviated 8-item single-community model was found to be stable and configurally invariant across time-points and treatment groups. Symptoms such as low mood and lassitude showed most centrality across all models. LIMITATIONS:Metric invariance could not be explored due to research environment limitations. CONCLUSIONS:An 8-item one-community variant of the MADRS may provide optimal performance when conducting network analyses of antidepressant clinical trial outcomes. Findings suggest that interventions targeting low mood and lassitude might be most efficacious in treating depression among clinical trial participants. Further considerations of the potential impact on trial design and analysis should be explored.

Introduction Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.Methods and analysis Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.Ethics and dissemination The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.Trial registration numbers NCT05575128, NCT05685511, NCT05697835, pre-results.

Increasingly, studies use social media to recruit, enroll, and collect data from participants. This introduces a threat to data integrity: efforts to produce fraudulent data to receive participant compensation, e.g., gift cards. MOMENT is an online symptom-monitoring and self-care study that implemented safeguards to protect data integrity. Facebook, Twitter, and patient organizations were used to recruit participants with chronic health conditions in four countries (USA, Italy, The Netherlands, Sweden). Links to the REDCap baseline survey were posted to social media accounts. The initial study launch, where participants completed the baseline survey and were automatically re-directed to the LifeData ecological momentary assessment app, was overwhelmed with fraudulent responses. In response, safeguards (e.g., reCAPTCHA, attention checks) were implemented and baseline data was manually inspected prior to LifeData enrollment. The initial launch resulted in 411 responses in 48 hours, 265 of which (64.5%) successfully registered for the LifeData app and were considered enrolled. Ninety-nine percent of these were determined to be fraudulent. Following implementation of safeguards, the re-launch yielded 147 completed baselines in 3.5 months. Eighteen cases (12.2%) were found fraudulent and not invited to enroll. Most fraudulent cases in the re-launch (15 of 18) were identified by a single attention check question. In total, 96.1% of fraudulent responses were to the USA-based survey. Data integrity safeguards are necessary for research studies that recruit online and should be reported in manuscripts. Three safeguard strategies were effective in preventing and removing most of the fraudulent data in the MOMENT study. Additional strategies were also used and may be necessary in other contexts.

In their recent Viewpoint article, Beidas et al. (2023) argue that researchers should test psychosocial interventions in the contexts in which they are meant to be delivered and that they can accelerate the deployment of these interventions by advancing directly from pilot trials to effectiveness and implementation studies without conducting efficacy trials. In this commentary, we argue that this is a well-intended but problematic approach and that there is a more productive strategy for translational behavioral intervention research. The commentary discusses issues concerning intervention development, refinement, and optimization; pilot and efficacy testing of interventions; the contexts in which interventions are delivered; clinical practice guidelines; and quick versus programmatic answers to significant clinical research questions. Testing psychosocial interventions in the contexts in which they are meant to be delivered is a complex task for interventions that are designed to be used in a wide variety of contexts. Nevertheless, interventions can be tested in the contexts in which they are meant to be delivered without sacrificing programmatic intervention development or safety and efficacy testing. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

ObjectiveInsights into how symptoms influence self-care can guide patient education and improve symptom control. This study examined symptom characteristics, causal attributions, and contextual factors influencing self-care of adults with arthritis, asthma, chronic obstructive pulmonary disease, diabetes, or heart failure.MethodsAdults (n = 81) with a symptomatic chronic illness participated in a longitudinal observational study. Using Ecological Daily Assessment, participants described one symptom twice daily for two weeks, rating its frequency, severity, bothersomeness, duration, causes, and self-care.ResultsThe most frequent symptoms were fatigue and shortness of breath. Pain, fatigue, and joint stiffness were the most severe and bothersome. Most participants engaged in active self-care, but those with fatigue and pain engaged in passive self-care (i.e., rest or do nothing), especially when symptoms were infrequent, mild, somewhat bothersome, and fleeting. In people using passive self-care, thoughts, feelings, and the desire to conceal symptoms from others interfered with self-care.ConclusionMost adults with a chronic illness take an active role in managing their symptoms but some conceal or ignore symptoms until the frequency, severity, bothersomeness, or duration increases.Practice implicationsWhen patients report symptoms, asking about self-care behaviors may reveal inaction or ineffective approaches. A discussion of active self-care options may improve symptom control.