Creating a best practice template for participant communication plans in global health clinical studies.

BACKGROUND: Clinical trial participants have a right to be informed throughout the entire process of human subject research. As part of this pillar of research ethics, participants and other stakeholders should be made aware of research findings after a trial has been completed. Though participants have both a right, and a desire to be informed of research outcomes, studies show that they rarely receive communication about study findings. Our aim was (1) to understand what, if any, role communication plans play in current global health clinical research protocols and (2) to use our findings to develop a communication plan template tailored to clinical research carried out in low-and-middle-income countries (LMIC) while minimizing colonial assumptions. While the template was drafted in the LMIC context, the principles are universally applicable and should be considered best practices for all global health clinical trials. METHODS: We carried out a mixed-method study over a period of 6 months to understand the role of communication with study participants and other stakeholders in clinical trials. The semiquantitative analysis included mining publicly available clinical trial protocols for communication-related language. Qualitative interviews (n = 7) were used to gather knowledge and insight from clinical trial experts to inform the development of a communication plan template. RESULTS: None of the 48 mined clinical trial protocols included a communication plan. Of the 48, 21% (n = 21) protocols included communication-related language, and 10% (n = 5) described plans to share trial results with participants. CONCLUSION: The use of communication plans in global health clinical trials is lacking. To our knowledge, this is the first in-depth analysis of communication plans in clinical trials to date. We recommend that researchers utilize the developed communication plan template throughout the entire research process to ensure a human-centered approach to participant communication. This communication plan should apply to all phases of a research trial, with a particular emphasis on plans to share results in an accessible and engaging manner once the trial has been completed.

Evaluating the Test Validity of the Comprehensive Assessment of Psychopathic Personality Symptom Rating Sale (CAPP SRS).

The Comprehensive Assessment of Psychopathic Personality Symptom Rating Scale (CAPP SRS) is a relatively new measure of psychopathic personality disorder (PPD) based on the CAPP concept map of psychopathy. To investigate the CAPP SRS, we identified the most plausible formal test structure for the test using the framework proposed by Slaney and Maraun, identified an appropriate quantitative characterization of that test structure, and then statistically evaluated it based on analysis of CAPP SRS data collected from a multisite sample of 314 adult male correctional offenders and secure hospital patients in Scotland and England. Overall, the CAPP SRS survived falsification when observed test data were compared to expectations based on the unidimensional monotone latent variable or UMLV model of Holland and Rosenbaum. CAPP SRS composite scores calculated consistent with the UMLV model had good measurement precision and good external validity with respect to scores on an established test of PPD. The findings provide provisional support for the test validity of the CAPP SRS and highlight the importance of theory-driven evaluations of test validity.

Personal recovery and its challenges in forensic mental health: systematic review and thematic synthesis of the qualitative literature.

BACKGROUND: There has been a call for a framework to guide recovery-oriented practices in forensic mental health services. AIMS: This study aims to examine personal recovery and its challenges in forensic mental health settings in relation to the established framework for personal recovery in mental illness: connectedness, hope, identity, meaning and empowerment (CHIME). METHOD: This study is an updated and expanded systematic review and thematic synthesis of the qualitative literature. A systematic search of six electronic databases (Web of Science, Medline, PsycINFO, CINAHL, EMBASE and SocIndex) was carried out in January 2019, using the terms [Recover*] AND [Forensic OR Secure] AND [Patient* OR Offend* OR Service User*]. Only studies that included service user's own perceptions and were published from 2014 onward were included in the review. Data were examined with thematic synthesis and subsequently analysed in relation to the CHIME framework. RESULTS: Twenty-one studies were included in the review. Findings suggest that some adjustments to the original CHIME framework are needed for it to be more relevant to forensic populations, and that an additional recovery process regarding feeling safe and being secure (safety and security) could be added to CHIME, providing the CHIME-Secure framework (CHIME-S). Specific challenges and barriers for forensic recovery were identified and found to represent the opposite of the recovery processes defined by CHIME (e.g. hopelessness). CONCLUSIONS: We present the CHIME-S as a framework for the personal recovery processes of forensic mental health service users. The CHIME-S may guide the recovery-oriented work of forensic mental health services.

Relational interventions for organizational learning: An experience report.

INTRODUCTION: Quality improvement and implementation science practitioners identify relational issues as important obstacles to success. Relational interventions may be important for successful performance improvement and fostering Learning Health Systems. METHODS: This case report describes the experience and lessons learned from implementing a relational approach to organizational change, informed by Relational Coordination Theory, in a health system. Structured interviews were used to obtain qualitative participant feedback. Relational Coordination was measured serially using a validated seven-item survey. RESULTS: An initial, relational intervention on one unit promoted increased participant engagement, self-efficacy, and motivation that led to the spontaneous, emergent dissemination of relational change, and learning into other parts of the health system. Staff involved in the intervention reported increased systems thinking, enhanced focus on communication and relationships as key drivers for improvement and learning, and greater awareness of organizational change as something co-created by staff and executives. CONCLUSIONS: This experience supports the hypothesis that relational interventions are important for fostering the development of Learning Health Systems.

Impact of relational coordination on staff and patient outcomes in outpatient surgical clinics.

BACKGROUND: Pressures are increasing for clinicians to provide high-quality, efficient care, leading to increased concerns about staff burnout. PURPOSE: This study asks whether staff well-being can be achieved in ways that are also beneficial for the patient's experience of care. It explores whether relational coordination can contribute to both staff well-being and patient satisfaction in outpatient surgical clinics where time constraints paired with high needs for information transfer increase both the need for and the challenge of achieving timely and accurate communication. METHODOLOGY/APPROACH: We studied relational coordination among surgeons, nurses, residents, administrators, technicians, and secretaries in 11 outpatient surgical clinics. Data were combined from a staff and a patient survey to conduct a cross-sectional study. Data were analyzed using ordinary least squares and random effects regression models. RESULTS: Relational coordination among all workgroups was significantly associated with staff outcomes, including job satisfaction, work engagement, and burnout. Relational coordination was also significantly associated with patients' satisfaction with staff and their overall visit, though the association between relational coordination and patients' satisfaction with their providers did not reach statistical significance. PRACTICE IMPLICATIONS: Even when patient-staff interactions are relatively brief, as in outpatient settings, high levels of relational coordination among interdependent workgroups contribute to positive outcomes for both staff and patients, and low levels tend to have the opposite effect. Clinical leaders can increase the expectation of positive outcomes for both staff and their patients by implementing interventions to strengthen relational coordination.

Operationalizing the assessment and management of violence risk in the short-term.

Assessing risk of violence in the short term is crucial for managing and preventing violence, especially in institutions such as psychiatric units and prisons. Despite a lack of consensus on the definition of "short term", a number of recent tools and guidelines have been developed to aid short-term clinical decision-making. Whereas the supporting evidence for the new tools is impressive, limitations remain in terms of the focus on prediction, limited consideration of strengths, and poor integration with formulation and risk management. The Short-Term Assessment of Risk and Treatability (START) is a brief clinical guide for the dynamic assessment of risks, strengths and treatability. It focuses on short-term risks and the characteristics of the individual that, if changed, might lead to an increase or decrease in risk. The START has the potential to operationalize the structured professional judgment (SPJ) approach in order to inform the evaluation of multiple risk domains relevant to everyday psychiatric clinical practice. However, explicit guidance on integrating risk assessment, formulation and management is limited in the START and this paper describes the SPJ approach, reviews recent developments in approaches to risk, and considers how the START can be used to inform SPJ approaches and link risk assessment, formulation, and management.

The Comprehensive Assessment of Psychopathic Personality (CAPP): content validation using prototypical analysis.

The Comprehensive Assessment of Psychopathic Personality (CAPP; Cooke, Hart, Logan, & Michie, 2004) is a new personality-based model and clinical assessment of psychopathy. This study was the first to examine the content validity of the English-language CAPP. Content validation is a crucial part of the development and refinement of any new instrument. Prototypical analysis was used to evaluate the representativeness of CAPP symptoms to the psychopathy construct in adults. Symptoms were rated by international mental health professionals (N = 132). Findings support good content validity of the CAPP, with most symptoms rated as highly representative of psychopathy. Domains relating to interpersonal style were particularly prototypical. Confirmatory factor analyses further suggested that CAPP domains are highly unidimensional. However, some CAPP symptoms may be weaker items in the model and further refinement is needed.

Milestones to recovery: preliminary validation of a framework to promote recovery and map progress through the medium secure inpatient pathway.

BACKGROUND: Forensic mental health care in the UK has undergone a rapid expansion since the late 1990s. In medium secure units (MSUs), there is growing emphasis on developing care pathways without much theoretical underpinning. We developed a concept of 'Milestones to Recovery' (MTR) to measure progress through the MSU pathway. AIMS: Our aim was to validate the MTR framework. Our hypotheses were that patients scoring higher on the MTR Scale would be more likely to be aggressive to others in the following 6 months and resident in the acute areas of the unit and that those scoring lower would be more likely to be discharged within 6 months of the assessment. METHODS: An MTR scale was developed to enable the investigation of the validity of the MTR framework and evaluated with staff evaluations of 80 resident patients using a prospective, longitudinal and naturalistic design. RESULTS: The results suggest that the MTR framework is valid in discriminating between different stages on the MSU pathway. Therapeutic engagement was particularly important in terms of progress through the MSU, whereas current behaviour was important in predicting future aggression. CONCLUSIONS: Further research is required to test the MTR framework across different levels of security, with larger samples and within different populations. IMPLICATIONS FOR PRACTICE: Provides a framework to map progress through the service. Identifies key factors that influence recovery and rehabilitation. Potential to promote dialogue between patients and staff, and enhance motivation.

Personality disorder and violence: making the link through risk formulation.

The extant research demonstrates that the combination of personality disorder and violence implies severe dysfunction, poor responsivity to treatment, more serious and persistent violence, and higher recidivism rates. Thus, it comes as no surprise that personality disorder is included in many of the available guidelines for assessing and managing violence. Unsurprisingly, the combination of personality pathology and violence frequently presents the greatest challenge to services, even those in whom violence risk assessment and management practice is established and routine. Conceptual and methodological limitations pervade the literature and a full explanation of the nature of the association between personality pathology and violence is still awaited. Furthermore, current approaches to risk assessment fail to provide a systematic framework for assessors to use to make sense of the heterogeneous presentations typically found in individuals with personality disorder and violence. In this paper, formulation is proposed as the critical process linking risk assessment and risk management. It is argued that assessors must move beyond a simple listing of risk factors and should instead produce detailed, comprehensive, individualized explanations of risk potential and risk management needs. Personality disorder is used in this paper to illustrate the important contribution of formulation to the risk assessment process, and in doing so, the link between personality pathology and violence is explored.

Mental disorder in violent women in secure settings: potential relevance to risk for future violence.

The relevance to women of common violence risk factors identified in men has in many instances yet to be established. Consequently, there is a reluctance to accept without question the application to women of practices relating to violence risk assessment and management developed from research into men. This study examines mental disorder in women who are violent in order comment on its relevance to the practice of violence risk assessment and management. A sample of 95 violent women in high secure prison and forensic psychiatric care were assessed. Structured assessments of Axis I and II mental disorders and psychopathy were undertaken on all women and conviction histories were recorded. Very high levels of psychiatric morbidity were noted and patterns in comorbidity were detected. Among Axis I conditions, psychotic disorders and disorders of mood co-occurred at a very high rate. Among the Axis II conditions, dimensional ratings of borderline personality disorder (PD) correlated with dimensional ratings of avoidant, dependent and paranoid PDs while ratings of antisocial PD correlated with those of narcissistic, histrionic and obsessive-compulsive PDs. Women who had been incarcerated for a major violent offence were four times more likely to have a diagnosis of borderline PD than women whose index offence was one of minor violence. A number of the findings reported are in contrast to those reported in similar studies of men. Findings suggest that practitioners are right to question the application to women of knowledge derived from research into men. The practice of violence risk assessment and management with women should emphasise the development of individual risk formulations and responding to psychiatric comorbidity should be the rule rather than the exception with this population.

Identifying psychopathic subtypes: combining an empirical personality classification of offenders with the psychopathy checklist-revised.

Mentally disordered offenders who were psychopathic according to the Psychopathy Checklist-Revised (PCL-R) were divided into primary psychopath, secondary psychopath, controlled, and inhibited groups on the basis of a validated empirical classification, using the Antisocial Personality Questionnaire (APQ). They were compared on the factors and facets of the PCL-R, criminal history, Axis I and Axis II psychopathology, experience of child abuse, personality, interpersonal style, and clinical ratings of risk and treatability, to determine the utility of the APQ classification in identifying subtypes of psychopath. Significant differences between APQ primary and secondary psychopaths on several measures support the identification of these groups with the primary and secondary psychopaths hypothesized by Karpman (1948) and others. However, further differences suggest that the controlled and inhibited groups represent additional variants of primary and secondary psychopath, respectively. The results provide further evidence for the heterogeneity of psychopaths, and suggest that the PCL-R encompasses several distinct subtypes of abnormal personality.

Assessing interpersonal aspects of schizoid personality disorder: preliminary validation studies.

In 2 studies, we examined the reliability and validity of an interpersonal measure of schizoid personality disorder (SZPD) based on nonverbal behaviors and interpersonal interactions occurring during interviews. A total of 556 male jail inmates in the United States participated in Study 1; 175 mentally disordered offenders in maximum security hospitals in the United Kingdom participated in Study 2. Across both samples, scores on the Interpersonal Measure of Schizoid Personality Disorder (IM-SZ) exhibited adequate reliability and patterns of correlations with other measures consistent with expectations. The scale displayed patterns of relatively specific correlations with interview and self-report measures of SZPD. In addition, the IM-SZ correlated in an expected manner with features of psychopathy and antisocial personality and with independent ratings of interpersonal behavior. We address implications for assessment of personality disorder.

The Violence Risk Scale Second Edition (VRS-2) as a predictor of institutional violence in a British forensic inpatient sample.

This study examined the utility of The Violence Risk Scale 2nd Edition (VRS-2) [Wong, S., Gordon, A., 1999. Manual for the Violence Risk Scale. University of Saskatchewan, Saskatchewan, Canada] as an institutional violence risk predictor. The VRS-2 and the Psychopathy Checklist: Screening Version (PCL: SV) were rated independently from pre-admission/admission case records in 147 patients in a medium security facility. Inpatient aggression post-admission was recorded by an independent researcher. Aggressive patients had significantly higher scores on both measures. The VRS-2 and the PCL: SV were only modest predictors of inpatient aggression. The VRS-2 putative "dynamic" items showed the highest predictive accuracy. The results tentatively support the use of the VRS-2 as a predictor of inpatient violence in mentally ill patients in medium security settings, with the dynamic component of this instrument showing most promise. Further studies validating this instrument are required before it is adopted into routine clinical practice.

Higher-order dimensions of personality disorder: hierarchical structure and relationships with the five-factor model, the interpersonal circle, and psychopathy.

Two studies examined the higher-order factor structure of DSM-IV personality disorders using the International Personality Disorder Examination in male forensic psychiatric patients. In Study 1 (N = 168), exploratory factor analysis at the level of individual personality disorder criteria indicated nine primary factors. Exploratory and confirmatory factor analyses of these first-order factors supported a hierarchical structure in which two of three second-order factors covaried to yield a third-order factor. The two resulting superordinate factors were labelled Anxious-Inhibited and Acting Out. In Study 2 (N = 160), we used exploratory and confirmatory factor analyses to test hypotheses of common dimensions underlying these superordinate factors of personality disorder and superordinate factors of the five-factor model of personality, dimensions of the interpersonal circle, and psychopathy. Of three common factors, one combined Anxious-Inhibited disorders, "neurotic introversion," and hostile-submission. The other two factors of Acting Out/ psychopathy and antagonism/hostile-dominance covaried to yield a superordinate factor. Possible substrates underlying two superordinate dimensions common to normal and abnormal personality were identified in the theoretical literature.

Convergent and discriminative validity of interview and questionnaire measures of personality disorder in mentally disordered offenders: a multitrait-multimethod analysis using confirmatory factor analysis.

Measures of personality disorder from the International Personality Disorder Examination, Personality Diagnostic Questionnaire, and Millon Clinical Multiaxial Inventory (MCMI-II) were obtained from detained male mentally disordered offenders (N = 156), and convergent and discriminant validity were examined by confirmatory factor analysis of the multitrait-multimethod matrix. Hierarchical comparisons of models varying in their specification of trait and method variance established the appropriateness of a model supporting both convergence and discrimination across methods, but these were variable across constructs and measures. Convergence was good for avoidant, schizoid, and antisocial disorders, but poor for histrionic, narcissistic, and obsessive-compulsive disorders. Avoidant, schizoid, and schizotypal disorders were not clearly distinguishable from each other. Measurement error attributable to method variance was substantial for all instruments and for most disorders. The commonly alleged superiority of interview over questionnaire methods was not supported, and the MCMI-II demonstrated proportionately more "true" variance. However, assessment methods may be differentially sensitive to different kinds of personality disorder problems.