What influenced people with chronic or refractory breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study.

BACKGROUND: Recruitment and retention in clinical trials remains an important challenge, particularly in the context of advanced disease. It is important to understand what affects retention to improve trial quality, minimise attrition and reduce missing data. We conducted a qualitative study embedded within a randomised feasibility trial and explored what influenced people to take part and remain in the trial. METHODS: We conducted a qualitative study embedded within a double-blind randomised trial (BETTER-B[Feasibility]: BETter TreatmEnts for Refractory Breathlessness) designed using a person-centred approach. Participants with cancer, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), or chronic heart failure (CHF), with a modified Medical Research Council dyspnoea scale grade of 3/4 were recruited from three UK sites. A convenience subsample completed qualitative interviews after the trial. Interviews were analysed using thematic analysis. Results were considered in relation to the core elements of person-centred care and our model of the person-centred trial. RESULTS: In the feasibility trial 409 people were screened for eligibility, and 64 were randomised. No participant was lost to follow-up. Twenty-two participants took part in a qualitative interview. Eleven had a diagnosis of COPD, 8 ILD, 2 CHF and 1 lung cancer. The participants' median age was 71 years (range 56-84). Sixteen were male. Twenty had completed the trial, and two withdrew due to adverse effects. The relationship between patient and professional, potential for benefit, trial processes and the intervention all influenced the decision to participate in the trial. The relationship with the research team and continuity, perceived benefit, and aspects relating to trial processes and the intervention influenced the decision to remain in the trial. CONCLUSIONS: In this feasibility trial recruitment targets were met, attrition levels were low, and aspects of the person-centred approach were viewed positively by trial participants. Prioritisation of the relationship between the patient and professional; person-centred processes, including home visits, assistance with questionnaires, and involvement of the carer; and enabling people to participate by having processes in line with individual capabilities appear to support recruitment and retention in clinical trials in advanced disease. We recommend the integration of a person-centred approach in all clinical trials. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN32236160. Registered on 13 June 2016.

Mirtazapine for chronic breathlessness? A review of mechanistic insights and therapeutic potential.

INTRODUCTION: Chronic breathlessness is a common and distressing symptom of advanced disease with few effective treatments. Central nervous system mechanisms are important in respiratory sensation and control. Consequently, drugs which may modify processing and perception of afferent information in the brain may have a role. Antidepressants have been proposed; however, current evidence is limited. Of potentially suitable antidepressants, mirtazapine is an attractive option given its tolerability profile, low cost, and wide availability, along with additional potential benefits. Areas covered: The paper provides an overview of the physiology of breathlessness, with an emphasis on central mechanisms, particularly the role of fear circuits and the associated neurotransmitters. It provides a potential rationale for how mirtazapine may improve chronic breathlessness and quality of life in patients with advanced disease. The evidence was identified by a literature search performed in PubMed through to October 2018. Expert opinion: Currently, there is insufficient evidence to support the routine use of antidepressants for chronic breathlessness in advanced disease. Mirtazapine is a promising candidate to pursue, with definitive randomized controlled trials required to determine its efficacy and safety in this setting.

Gender differences in the progression of co-morbid psychopathology symptoms of eating disordered patients.

This study examined the utility of the Personality Assessment Inventory (PAI) in screening for comorbid psychopathology in eating disordered males and females undergoing residential treatment. The PAI, a self-administered screening tool containing 344 items to provide information on 11 clinical constructs, was administered at admission and discharge to 181 patients, 154 females and 27 males. Average age was 26.88 years (SD=9.35) and average length of stay was 58.31 days (SD=39.94). The results showed that both male and female patients exhibit several comorbid disorders at admission to residential treatment and the severity of these symptoms was statistically significantly reduced over the course of treatment. When comparing differences among genders, the results show that females present with more psychopathology symptoms at the start of treatment but make better progress than males in reducing these symptoms over time. When comparing patients across eating disorder diagnoses, subjects with bulimia displayed more severe comorbid symptomatology as compared to those with anorexia or other eating disorders. A thorough clinical assessment of eating disordered patients including comorbid psychopathology disorders is relevant for clinical diagnosis, treatment planning, and perhaps ultimately the outcome of treatment.

Occupational health. Working wounded.

The NHS has a relatively high level of sickness compared with the rest of the working population. A multidisciplinary project to improve workplace well-being allowed organisational, as well as personal, problems to be addressed. Evaluation of workplace counselling showed improvements in staff mental health. Feedback to managers allowed change to be made where problems were a result of policies, systems or behaviours.