Treatment effect quantification for time‐to‐event endpoints–Estimands,analysis strategies,and beyond

A draft addendum to ICH E9 has been released for public consultation in August 2017. The addendum focuses on two topics particularly relevant for randomized confirmatory clinical trials: estimands and sensitivity analyses. The need to amend ICH E9 grew out of the realization of a lack of alignment between the objectives of a clinical trial stated in the protocol and the accompanying quantification of the “treatment effect” reported in a regulatory submission. We embed time‐to‐event endpoints in the estimand framework and discuss how the four estimand attributes described in the addendum apply to time‐to‐event endpoints. We point out that if the proportional hazards assumption is not met, the estimand targeted by the most prevalent methods used to analyze time‐to‐event endpoints, logrank test, and Cox regression depends on the censoring distribution. We discuss for a large randomized clinical trial how the analyses for the primary and secondary endpoints as well as the sensitivity analyses actually performed in the trial can be seen in the context of the addendum. To the best of our knowledge, this is the first attempt to do so for a trial with a time‐to‐event endpoint. Questions that remain open with the addendum for time‐to‐event endpoints and beyond are formulated, and recommendations for planning of future trials are given. We hope that this will provide a contribution to developing a common framework based on the final version of the addendum that can be applied to design, protocols, statistical analysis plans, and clinical study reports in the future.     

Making Decisions about Parental Mental Health: An Exploratory Study of Community Mental Health Team Staff

Adult mental health problems can impact on parents, and research highlights that their children are at higher risk of developing mental health problems. In extreme cases, mental health problems are associated with a risk of fatal child abuse. Despite this, there are few studies exploring clinical decision‐making by adult mental health professionals.

‘In extreme cases, mental health problems are associated with a risk of fatal child abuse’

This study used qualitative methods to explore Community Mental Health Team (CMHT) workers' experiences of decision‐making in the interface between mental health and child welfare. Workers were interviewed about their experiences of clinical decision‐making regarding child welfare. Interviews and accounts were analysed using Interpretative Phenomenological Analysis. Influences on decision‐making were explored and triangulated with the accounts of Named Nurses for Child Protection. The findings revealed that CMHT participants were aware of their responsibilities towards children, but a complex synthesis of factors impacted on their sense‐making about risk and welfare. Three superordinate themes emerged: the tensions of working across systems; trying to balance the perceptions and feelings involved in sense‐making; and the role that interpersonal dynamics play in the understanding and management of risk. This paper focuses in particular on perceptions and feelings. Copyright © 2011 John Wiley & Sons, Ltd.

‘A complex synthesis of factors impacted on their sense‐making about risk and welfare’

Citing Literature

Number of times cited according to CrossRef: 8

• Natalie Elizabeth Anderson, Julia Slark, Merryn Gott, Unlocking intuition and expertise: using interpretative phenomenological analysis to explore clinical decision making, Journal of Research in Nursing, 10.1177/1744987118809528, 24 , 1-2, (88-101), (2019). Crossref
• Phillip Tchernegovski, Andrea E. Reupert, Darryl J. Maybery, How do Australian adult mental health clinicians manage the challenges of working with parental mental illness? A phenomenological study, Child & Family Social Work, 10.1111/cfs.12426, 23 , 3, (381-389), (2017). Wiley Online Library
• Maria Afzelius, Lars Plantin, Margareta Östman, Children of Parents With Serious Mental Illness: The Perspective of Social Workers, Practice, 10.1080/09503153.2016.1260705, 29 , 4, (293-310), (2016). Crossref
• Louise Everitt, Caroline Homer, Jennifer Fenwick, Working with Vulnerable Pregnant Women Who Are At Risk of Having their Babies Removed by the Child Protection Agency in New South Wales, Australia, Child Abuse Review, 10.1002/car.2432, 26 , 5, (351-363), (2016). Wiley Online Library
• Joe Duffy, Gavin Davidson, Damien Kavanagh, Applying the recovery approach to the interface between mental health and child protection services, Child Care in Practice, 10.1080/13575279.2015.1064358, 22 , 1, (35-49), (2015). Crossref
• Peter Sidebotham, What did you do at Work Today, Daddy?, Child Abuse Review, 10.1002/car.2357, 23 , 5, (307-310), (2014). Wiley Online Library
• Peter Sidebotham, Rethinking Filicide, Child Abuse Review, 10.1002/car.2303, 22 , 5, (305-310), (2013). Wiley Online Library
• Jane V. Appleton, Peter Sidebotham, Child Protection and Mental Health, Child Abuse Review, 10.1002/car.2220, 21 , 3, (153-156), (2012). Wiley Online Library

Volume 21 , Issue 3 May/June 2012

Pages 173-189     

Aggression in the academic workplace: a psychodynamic analysis of social work

Abstract

Aiming to promote quality collegial relationships in tertiary education, this theoretical study draws on the peer-reviewed literature to provide a psychodynamic analysis of workplace aggression in the social work discipline. Because the study assists academics to identify their aggressive practices and the aggressive practices of their colleagues, the findings can be of relevance to other practice-based disciplines. Elaborating on the causes and effects of the disciplinary, institutional and individual forms of aggression, this study identifies the avoidance of the emotional pain in work with clients as the main reason behind the active or passive–aggressive behaviours in the discipline. Academics act out this defensive manoeuvre through denying the existence of knowledge gaps in the discipline, denying the inextricable link between empirical research and theories of practice, teaching exclusively theories unsupported by empirical studies, and resisting to set boundaries on active and passive aggression. The study proposes the advancement of research-into-practice mindedness in social work schools, the requirement that prospective social work academics gain considerable practice experience before entering academia, the need for academic leadership positions to require peer-reviewed publications in both teaching and practice and the need for Schools to publish a volume of empirical research to be accredited as providers of social work education.     

Advocating the Clinical Social Work Professional Identity: A Biographical Study

Aiming to portray the clinical social work (CSW) professional identity, the present biographical study examines the CSW knowledge and practice domain boundaries as they appear from the perspectives of three Greek mental health social workers who have advocated for the professionalization of CSW. The practitioners' perspectives are studied in relation to their demographic characteristics, education and training, and multidisciplinary relationships. A thematic analysis of the in-depth interviews revealed that these practitioners retained their nuclear social work identity and felt their skills and interests to be different from those endorsed by the present generic social work education and practice system. The study also revealed differences in the educational qualifications and routes that each of the three practitioners followed in order to be able to identify themselves as ‘clinical social workers’. Although the common denominator in the practitioners' perspectives was their training in psychotherapy, the type of psychotherapy training pursued and the experience of personal psychotherapy differentiated each practitioner's ability to theorize on the CSW practice identity. The research data were filtered through a psychodynamic lens to reveal the dynamics of the unconscious processes within the relationships formed between individuals and organizations.     

Initial reflections and learning from the development and delivery of staff consultations in an innovative residential childcare pathway

ABSTRACT

This paper explores the development of staff consultation in the context of an innovative residential childcare pathway within a local authority in the United Kingdom. A preceding attempt to develop group consultations in residential homes has been expanded upon and enhanced as part of implementing a broader therapeutic residential service model. A wide-ranging training programme and consultations have been developed for residential childcare workers to introduce and embed therapeutic ideas. Systemic therapy and attachment theory ideas have been used explicitly through exploring with staff how these approaches can inform practice, and implicitly by providing a framework of consultation to inform and expand individual and team thinking. Promoting reflective practice through group consultations has highlighted complex challenges, stimulating opportunities as well as a need to consider multiple levels of context. Recommendations from this learning are discussed to help inform practice in new and existing residential services.     

Inference methods for saturated models in longitudinal clinical trials with incomplete binary data

In the longitudinal studies with binary response, it is often of interest to estimate the percentage of positive responses at each time point and the percentage of having at least one positive response by each time point. When missing data exist, the conventional method based on observed percentages could result in erroneous estimates. This study demonstrates two methods of using expectation-maximization (EM) and data augmentation (DA) algorithms in the estimation of the marginal and cumulative probabilities for incomplete longitudinal binary response data. Both methods provide unbiased estimates when the missingness mechanism is missing at random (MAR) assumption. Sensitivity analyses have been performed for cases when the MAR assumption is in question.     

Simple graphical methods of displaying multiple clinical results

A common challenge in clinical research trials is for applied statistics to manage, analyse, summarize and report an enormous amount of data. Nowadays, due to advances in medical technology, situations frequently arise where it is difficult to display and interpret results. Consequently, a creative approach is required to summarize the main outcomes of the statistical analyses in a form which is easy to grasp, to interpret and possibly to remember. In this paper a number of clinical case studies are provided. Firstly, a topographical map of the brain summarizing P-values obtained from comparisons across different EEG sites; secondly, a bulls eye plot, showing the agreement between observers in different regions of the heart; thirdly, a pictorial table reporting inter- and intra-rater reliability scores of a speech assessment; fourthly a star-plot to deal with numerous questionnaire results and finally a correlogram to illustrate significant correlation values between two diagnostic tools. The intention of this paper is to encourage the effort of visual representations of multiple statistical outcomes. Such representations do not only embellish the report, but aid interpretation by conveying a specific statistical meaning.     

临床医学本科毕业生就业情况调查与分析

随着医疗体制的改革,高等医学教育呈现跨越式发展,医学类毕业生人数逐年增加,而社会对临床医学本科生的需求却明显下降。以某医学高校2014届临床医学专业毕业生为例,对就业单位性质、医疗卫生单位等级程度、医疗卫生单位区域、2014年各月月底就业情况进行分类统计与分析,进一步探讨相应的对策和建议,旨在为同类高校的就业工作提供参考。     

The role of age and setting in adolescents’ first drinking experience for predicting college problem drinking

Objective: The purpose of this study was to determine the reliability of longitudinally reporting age at first drink (AFD), and to test AFD and setting of first drink (SFD) as predictors of collegiate problem drinking. Participants: 338 first-year college students were interviewed multiple times during their first academic year, from May 2011 through August 2012. Methods: AFD, SFD, and problem drinking were measured using the Alcohol Use Disorders Identification Test (AUDIT) during the first year of college. Bivariate analysis and parsimonious multivariate linear regression model were conducted. Results: 62% of respondents were inconsistent in reporting AFD over time. Social SFD was the strongest independent predictor for higher AUDIT scores (b = 4.74, 95% confidence interval; 1.91, 7.57; p = .002). Conclusions: Findings suggest caution should be used in relying upon using AFD as a sole predictor of problem drinking. SFD may be a complementary measure to identify students at high risk of collegiate problem drinking.