Using a patient-centred composite endpoint in a secondary analysis of the Control of Hypertension in Pregnancy Study (CHIPS) Trial.

BACKGROUND: Clinical trials commonly use multiple endpoints to measure the impact of an intervention. While this improves the comprehensiveness of outcomes, it can make trial results difficult to interpret. We examined the impact of integrating patient weights into a composite endpoint on the interpretation of Control of Hypertension in Pregnancy Study (CHIPS) Trial results. METHODS: Outcome weights were extracted from a previous patient preferences study in pregnancy hypertension (N = 183 women) which identified (i) seven outcomes most important to women (taking medication, severe hypertension, pre-eclampsia, blood transfusion, Caesarean, delivery < 34 weeks, and baby born smaller-than-expected) and (ii) three preference subgroups: (1) 'equal prioritizers', 62%; (2) 'early delivery avoiders', 23%; and (3) 'medication minimizers', 14%. Outcome weights from the preference subgroups were integrated with CHIPS data for the seven outcomes identified in the preference study. A weighted composite score was derived for each participant by multiplying the preference weight for each outcome by the binary outcome if it occurred. Analyses considered equal weights and those from the preference subgroups. The mean composite scores were compared between trial arms (t-tests). RESULTS: Composite scores were similar between trial arms with the use of equal weights or those of subgroup (1) (95% confidence intervals [CIs]: - 0.03, 0.02; p > 0.50 for each). 'Tight' control was superior when using subgroup (2) weights (95% CIs: 0.002, 0.07; p = 0.03), and 'less-tight' control was superior when using subgroup (3) weights (95% CIs: - 0.11, - 0.04; p < 0.01). CONCLUSIONS: Evidence-based recommendations for 'tight' control are consistent with most women's preferences, but for a sixth of women, 'less-tight' control is more preference consistent. Depending on patient preferences, a single trial may support different interventions. Future trials should specify component weights to improve interpretation. TRIAL REGISTRATION: ClinicalTrials.gov NCT01192412.

IMplementing Predictive Analytics towards efficient COPD Treatments (IMPACT): protocol for a stepped-wedge cluster randomized impact study.

INTRODUCTION: Personalized disease management informed by quantitative risk prediction has the potential to improve patient care and outcomes. The integration of risk prediction into clinical workflow should be informed by the experiences and preferences of stakeholders, and the impact of such integration should be evaluated in prospective comparative studies. The objectives of the IMplementing Predictive Analytics towards efficient chronic obstructive pulmonary disease (COPD) treatments (IMPACT) study are to integrate an exacerbation risk prediction tool into routine care and to determine its impact on prescription appropriateness (primary outcome), medication adherence, quality of life, exacerbation rates, and sex and gender disparities in COPD care (secondary outcomes). METHODS: IMPACT will be conducted in two phases. Phase 1 will include the systematic and user-centered development of two decision support tools: (1) a decision tool for pulmonologists called the ACCEPT decision intervention (ADI), which combines risk prediction from the previously developed Acute COPD Exacerbation Prediction Tool with treatment algorithms recommended by the Canadian Thoracic Society's COPD pharmacotherapy guidelines, and (2) an information pamphlet for COPD patients (patient tool), tailored to their prescribed medication, clinical needs, and lung function. In phase 2, we will conduct a stepped-wedge cluster randomized controlled trial in two outpatient respiratory clinics to evaluate the impact of the decision support tools on quality of care and patient outcomes. Clusters will be practicing pulmonologists (n ≥ 24), who will progressively switch to the intervention over 18 months. At the end of the study, a qualitative process evaluation will be carried out to determine the barriers and enablers of uptake of the tools. DISCUSSION: The IMPACT study coincides with a planned harmonization of electronic health record systems across tertiary care centers in British Columbia, Canada. The harmonization of these systems combined with IMPACT's implementation-oriented design and partnership with stakeholders will facilitate integration of the tools into routine care, if the results of the proposed study reveal positive association with improvement in the process and outcomes of clinical care. The process evaluation at the end of the trial will inform subsequent design iterations before largescale implementation. TRIAL REGISTRATION: NCT05309356.

Feasibility of Testing Client Preferences for Accessing Injectable Opioid Agonist Treatment (iOAT): A Pilot Study.

Purpose: Injectable opioid agonist treatment (iOAT) is an effective treatment for opioid use disorder (OUD). To our knowledge, no research has systematically studied client preferences for accessing iOAT. Incorporating preferences could help meet the heterogenous needs of clients and make addiction care more person-centred. This paper presents a pilot study of a best-worst scaling (BWS) preference elicitation survey that aimed to assess if the survey was feasible and accessible for our population and to test that the survey could gather sound data that would suit our planned analyses. Patients and Methods: Current and former iOAT clients (n = 18) completed a BWS survey supported by an interviewer using a think-aloud approach. The survey was administered on PowerPoint, and responses and contextual field notes were recorded manually. Think-aloud audio was recorded on Audacity. Results: Clients' feedback fell into five categories: framing of the task, accessibility, conceptualization of attributes and levels, formatting, and behaviour predicting questions. Survey repetitiveness was the most consistent feedback. The data simulation showed that 100 responses should provide an adequate sample size. Conclusion: This pilot demonstrates the type of analysis that can be done with BWS in our population, suggests that such analysis is feasible, and highlights the importance of the interviewer and participant working side-by-side throughout the task.

Patient Preferences and Decisional Needs When Choosing a Treatment Approach for Pregnancy Hypertension: A Stated Preference Study.

The Hypertension Canada 2018 clinical guidance for pregnancy hypertension recommends antihypertensive therapy for raised blood pressure in pregnancy to a target diastolic blood pressure (BP) of 85 mm Hg (ie, "tight" control). Although evidence shows this approach reduces the incidence of severe maternal hypertension without increasing risk to the baby, we do not know how pregnant women feel about this approach, particularly as they are generally medication averse. An online survey assessed pregnant women's preferences for management of pregnancy hypertension and explored decisional needs. The survey included information provision and knowledge assessment, a preference elicitation task, and a decisional needs assessment. Survey responses were analysed descriptively, by latent class analysis to identify treatment priority subgroups, and by logistic regression to assess predictors of treatment preference. For the 183 pregnant respondents, 3 treatment priority subgroups were identified, with most respondents expressing equal prioritization of treatment outcomes and components (eg, taking medication). Participants who preferred tight control (49%) were more often white (odds ratio [OR]: 2.38; 95% confidence interval [CI]: 1.18-4.55), with a university education/professional qualification (OR 1.95; 95% CI: 1.02-3.7), and had greater knowledge about pregnancy hypertension and pregnancy complications (OR 1.37; 95% CI: 1.15-1.65). Participants reported diverse decisional needs, but most preferred to make final treatment decisions themselves (70%), with (48%) or without (22%) physician input. The diversity of priorities, preferences, and decisional needs for management of pregnancy hypertension identified in this study emphasises the importance of an individualized approach to treatment recommendations.

A laboratory examination of emotion regulation skill strengthening in borderline personality disorder.

This study examined whether individuals with borderline personality disorder (BPD; N = 25) exhibit deficits in their ability to strengthen their emotion regulation skills over time compared with healthy controls (HCs; N = 30). Participants were instructed to implement 1 of 2 different emotion regulation strategies (i.e., distraction and mindful awareness of the emotion) or to either react naturally (i.e., nonregulation condition) in response to BPD-relevant stimuli across multiple trials. Self-reported negativity and positivity, and physiological indices of emotion were collected throughout. Self-report results indicated that both groups displayed strengthening of distraction, but not mindful awareness, compared with the nonregulation condition over time. When comparing the 2 emotion regulation strategies to each other, heart rate data suggested that the rate of skill strengthening varied by group. Specifically, the BPD group evidenced strengthening of mindful awareness, but not distraction, over time whereas the HCs exhibited the opposite pattern. These findings suggest that individuals with BPD generally do not show deficits in their ability to strengthen emotion regulation skills and exhibit greater strengthening of mindful awareness than distraction over time. (PsycINFO Database Record

A multi-method laboratory investigation of emotional reactivity and emotion regulation abilities in borderline personality disorder.

BACKGROUND AND OBJECTIVES: Borderline personality disorder (BPD) is conceptualized as a disorder of heightened emotional reactivity and difficulties with emotion regulation. However, findings regarding emotional reactivity in BPD are mixed and there are limited studies examining emotion regulation capabilities in this population. METHODS: Twenty-five individuals with BPD and 30 healthy controls (HCs) engaged in a baseline assessment followed by the presentation of neutral and BPD-relevant negative images. Participants were instructed to react as they naturally would to the image, or to use a mindfulness-based or distraction-based strategy to feel less negative. Self-reported and physiological (i.e., heart rate, electrodermal activity, and respiratory sinus arrhythmia) measures were collected. RESULTS: Compared with the HCs, the BPD group exhibited elevated heart rate and reduced respiratory sinus arrhythmia at baseline. However, there were no differences in emotional reactivity in self-report or physiological indices between the two groups. In addition, the BPD group did not exhibit deficits in the ability to implement either emotion regulation strategy, with the exception that the BPD group reported less positive emotions while distracting compared with the HCs. LIMITATIONS: This study is limited by a small sample size and the inclusion of a medicated BPD sample. CONCLUSIONS: Emotion dysregulation in BPD might be better accounted for by abnormal baseline emotional functioning rather than heightened emotional reactivity or deficits in emotion regulation. Treatments for BPD might be enhanced by directly targeting resting state emotional functioning rather than emotional reactions or regulatory attempts.