External advisory committees (EACs) are critical peer-review meetings that drive improvement at Clinical and Translational Science Award Program Hubs. Despite their ubiquity, evaluations of EAC optimization and effective implementation remain scarce. We present a two-tiered approach to optimizing EAC meetings through (1) in-depth, topically focused “pre-review” meetings comprised of external topic experts and at least one standing “full-board” EAC member, followed by (2) a traditional “full-board” EAC meeting. This approach allowed pre-review discussion of program-focused topics and specific recommendations, later delivered to the full-board for review and direction. To evaluate this approach, we interviewed 18 people who planned, administered, or attended pre-review and/or full-board meetings, including internal Hub staff, external topic experts, and standing EAC members. Thematic analysis was used to explore planning, implementation, and value of our two-tiered approach versus the traditional single full-board approach. Interviewees preferred the two-tiered approach, noting benefits including additional time to reflect, shared identification of strengths and challenges, and discussion of solutions to share later with the full-board. Those who attended pre-review meetings described building “transformational,” rather than “transactional,” relationships with invitees through more discussion and inter-hub sharing. That increased sharing invited more exploration, discussion, and planning of next steps toward innovation.

Objectives: The current study used a mixed-method design to qualitatively examine parents’ definitions of resilience and factors they believed optimized their child’s early outcome following neonatal brain injury. This was followed by quantitative analyses of early developmental and mental health outcomes and their relation to salient biopsychosocial factors. Methods: Participants were parents of children diagnosed with neonatal brain injury due to stroke or hypoxic-ischemic encephalopathy (N=51; age range of children 18 months to 8 years). The Parent Experiences Questionnaire (PEQ) was used to qualitatively analyze parents’ open-ended responses about their child’s early experiences and outcome. The Child Behavior Checklist (CBCL) and Scales of Independent Behaviour Early Developmental Form (SIB-ED) parent ratings were used to measure child resilience from a quantitative perspective, identifying “at-risk” and “resilient” children using standard cutoffs. “Resilient” and “at-risk” children were compared on biopsychosocial variables using univariate t tests and chi-square analyses. Results: Parents provided five unique definitions of their child’s positive outcomes, and many children demonstrated resilience based on parent perspectives and quantitative definitions. Supporting factors included close medical follow-up, early intervention, and intrinsic factors within the child and parent. Group comparisons of “resilient” and “at-risk” children highlighted the importance of parent mental health across these early developmental and mental health outcomes. Conclusions: Many children were described as resilient during the early years by parents using qualitative and quantitative approaches. Findings highlighted the importance of parent well-being in promoting optimal early outcomes. (JINS, 2019, 25, 390–402.)

Despite the acknowledged importance of clinical supervision, controlled research is minimal and has rarely addressed the measurement or manipulation of clinical supervision, hampering our understanding and application of the different supervision methods. We therefore compared two related approaches to supervision, cognitive-behavioural (CBT) and evidence-based clinical supervision (EBCS), evaluating their relative effectiveness in facilitating the experiential learning of one supervisee. Drawing on a multiple-baseline N = 1 design, we gathered mostly qualitative data by means of an episode analysis, a content analysis, a satisfaction questionnaire, and interviews with the supervisor and supervisee. We found that the EBCS approach was associated with higher supervision fidelity and increased engagement in experiential learning by the supervisee. This case study in the evaluation of supervision illustrates the successful application of some rarely applied qualitative methods and some potential supervision enhancements, which could contribute to the development of CBT supervision.

Conditionality has increasingly been part of benefit entitlement and its effects have been examined in a number of ways. While the focus of previous research has been on general conditions such as job search and acceptance of job offers, this paper examines conditionality specifically in relation to participation in training. Using data from a qualitative evaluation of a government programme, the Skills Conditionality pilot, the paper uses two hypotheses to critically assess the effectiveness of conditionality as a benefits policy: that it is successful in increasing participation in training; and that it is harmful by reducing time for job search.

This paper describes a pilot study to evaluate the effectiveness of a school-based parenting programme combining the use of both affective (related to feelings) and behavioural strategies. In this paper we describe the intervention, its evaluation and a summary of the quantitative information gathered. The three pre-eminent ways in which parents appeared to have benefited from this particular programme included (1) the support they received in their parenting role from other parents, including a mirroring of problems, (2) the regaining of a sense of control in the parental role, in part through an increase in their capacity to think about matters calmly, and also through the provision of new tools with which to do the job of parenting, and (3) an increased ability to empathize and identify with their children, and a better understanding of the factors which motivate children to behave in particular ways. The capacity to think about matters calmly and the ability to empathize and identify with children appeared to be important factors in the reduction of inappropriate and unhelpful parenting practices such as shouting and smacking. It is suggested that empathy in particular is central to effective parenting, and that these results support the suggestion that there is an important added benefit for parents from programmes which combine behavioural and affective strategies focusing on feelings, relationships within the family, and the parents' own experience of being parented. The limitations of the data are discussed with reference to its reliability and validity, and the need for further research using grounded theory with other groups of parents.

Objective: Disabling breathlessness is the most common symptom of advanced cardiopulmonary disease. It is usually intractable, even when patients receive maximal medical therapy for their underlying condition. A pilot study was undertaken to evaluate a newly formed palliative Breathlessness Intervention Service (BIS).

Methods: The methodology followed the Medical Research Council's Framework for the Evaluation of Complex Interventions (Phase I). Qualitative interviews were completed with patients and relatives who had used the service and clinicians who had referred to it. The focus of the interviews was the participants' experience of using BIS.

Results: Patients valued the positive educational approach taken to breathlessness, emphasizing what was possible rather than what had been lost. Non-pharmacological strategies, especially the hand-held fan and exercises, were rated very helpful and new to patients. Participants reiterated that breathlessness was frightening and isolating, exacerbating the disability it caused: the easy access to advice and flexibility of BIS helped to alleviate this. Participants wanted a written record of the advice given. Carers welcomed the focus on their needs. Clinicians valued sharing the management of patients with an intractable problem.

Significance of results: This Phase I study has helped to remodel the service rapidly by uncovering the aspects of BIS that users find most valuable and areas that need change or improvement. The BIS needs to provide written information, to reinforce and extend contacts with other agencies to build on support it already provides for patients and carers, and extend its flexibility and accessibility. Providing a “drop-in” service and continuing education after the initial program of contacts is completed could be a useful service development, warranting further evaluation. A qualitative methodology involving service users and referrers can help to shape service development rapidly.

Objectives: To identify core issues that contribute to the gap between pre-marketing clinical research and practice as seen from the perspective of medical practice, as well as possible changes and potential barriers for closing this gap.

Methods: Interviews with 47 physicians and pharmacists who were liaised to drug regulation through their role in the pre- and post-marketing shaping of new cardiovascular drugs. Data were analyzed using methods of grounded theory and analytical evaluations.

Results: Six core issues were identified that referred to the standards in drug regulation, the organization of the regulatory system, and conflicting interests. Pre-marketing trials should focus more on populations and research questions relevant to medical practice. In particular, variability in drug responses between subgroups of patients and demonstration of effectiveness should become major principles in drug regulation. An interactive post-marketing process in which public interests are represented was considered necessary to further guide research and development according to the needs in daily practice. Strategies for change could be applied within the present system of drug regulation, or affect its basic principles. Regulatory authorities were primarily identified to initiate changes, but many other parties should be involved. Barriers for change were identified regarding differences in interests between parties, organizational matters, and with respect to broader healthcare policies.

Conclusions: Based on the respondents' opinions, there is a need to focus regulatory standards more on the needs in medical practice. Therefore, regulatory authorities should further develop their influence in the pre- and post-marketing drug development process, together with other parties involved, in order to bridge the gap between clinical research and medical practice.

Objectives: To study considerations used by professional and academic leaders to assess the position of new cardiovascular drugs in the therapeutic regimen in relationship to professional characteristics and the level of prescribing.

Methods: Interviews with 39 internists, cardiologists, general practitioners, and hospital pharmacists about considerations regarding the therapeutic position and prescribing of a new cardiovascular drug (losartan or atorvastatin) and professional characteristics. Considerations were classified according to Rogers' characteristics of an innovation, i.e., referring to the drug's relative advantage, compatibility, or complexity. Proportions of respondents mentioning advantageous, comparable, and/or disadvantageous characteristics were used to construct patterns to analyze an overall evaluation of the drugs in relation to professional characteristics and level of prescribing.

Results: The majority of considerations referred to the degree of relative advantage, but different subjects were emphasized for both drugs. Overall patterns of evaluation were generally intermediate and negative. The respondents' profession, mentioning commercial sources of information and self-qualification as a (moderately) early adopter of new drugs differentiated the overall evaluation of the drugs, in contrast to expertness and academic affiliation. The level of prescribing differentiated the overall evaluation only in the case of losartan.

Conclusions: These professional and academic leaders critically evaluated the claims when assessing the position of the drugs in the therapeutic regimen but did not show consensus in their considerations. Accepted principles for prescribing were considered when assessing the therapeutic position of the drugs but resulted in varied tendencies for prescribing.