Caught in the eye of the storm: a qualitative study of views and experiences of planned drug holidays from methylphenidate in child and adolescent ADHD treatment

Background: Attention deficit hyperactivity disorder (ADHD) can be treated with stimulant medication such as methylphenidate. Although effective, methylphenidate can cause serious side-effects, including suppressed appetite, growth retardation and sleep problems. A drug holiday is a deliberate interruption of pharmacotherapy for a defined period of time and for a specific clinical purpose, for example for appeasing side-effects. Whilst some international guidelines recommend introducing drug holidays in ADHD treatment, this is not practised routinely. Our aim was to examine the views and experiences of planned drug holidays from methylphenidate with adults who have responsibility for treatment decisions in children and adolescents with ADHD. Method: In-depth interviews were carried out. Child and Adolescent Mental Health Services (CAMHS) practitioners (n=8), General Practitioners (n=8), teachers (n=5), and mothers of children with ADHD (n=4) were interviewed in a UK setting. Interview transcripts were analysed using grounded theory. Results: Methylphenidate eases the experience of the child amid problems at home and at school and once started is mostly continued long-term. Some families do practise short-term drug holidays at weekends and longer-term ones during school holidays. The decision to introduce drug holidays is influenced by the child’s academic progress, the parents’ ability to cope with the child, as well as medication beliefs. Trialling a drug holiday is thought to allow older children to self-assess their ability to manage without medication when they show signs of wanting to discontinue treatment prematurely. Conclusions: Planned drug holidays could address premature treatment cessation by enabling adolescents to assess repercussions under medical supervision.

Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials

Background Appropriately conducted adaptive designs (ADs) offer many potential advantages over conventional trials. They make better use of accruing data, potentially saving time, trial participants, and limited resources compared to conventional, fixed sample size designs. However, one can argue that ADs are not implemented as often as they should be, particularly in publicly funded confirmatory trials. This study explored barriers, concerns, and potential facilitators to the appropriate use of ADs in confirmatory trials among key stakeholders. Methods We conducted three cross-sectional, online parallel surveys between November 2014 and January 2015. The surveys were based upon findings drawn from in-depth interviews of key research stakeholders, predominantly in the UK, and targeted Clinical Trials Units (CTUs), public funders, and private sector organisations. Response rates were as follows: 30(55 %) UK CTUs, 17(68 %) private sector, and 86(41 %) public funders. A Rating Scale Model was used to rank barriers and concerns in order of perceived importance for prioritisation. Results Top-ranked barriers included the lack of bridge funding accessible to UK CTUs to support the design of ADs, limited practical implementation knowledge, preference for traditional mainstream designs, difficulties in marketing ADs to key stakeholders, time constraints to support ADs relative to competing priorities, lack of applied training, and insufficient access to case studies of undertaken ADs to facilitate practical learning and successful implementation. Associated practical complexities and inadequate data management infrastructure to support ADs were reported as more pronounced in the private sector. For funders of public research, the inadequate description of the rationale, scope, and decision-making criteria to guide the planned AD in grant proposals by researchers were all viewed as major obstacles. Conclusions There are still persistent and important perceptions of individual and organisational obstacles hampering the use of ADs in confirmatory trials research. Stakeholder perceptions about barriers are largely consistent across sectors, with a few exceptions that reflect differences in organisations’ funding structures, experiences and characterisation of study interventions. Most barriers appear connected to a lack of practical implementation knowledge and applied training, and limited access to case studies to facilitate practical learning. Keywords: Adaptive designs; flexible designs; barriers; surveys; confirmatory trials; Phase 3; clinical trials; early stopping; interim analyses

Interim analyses and sequential designs in phase III studies

Recruitment of patients to a clinical trial usually occurs over a period of time, resulting in the steady accumulation of data throughout the trial's duration. Yet, according to traditional statistical methods, the sample size of the trial should be determined in advance, and data collected on all subjects before analysis proceeds. For ethical and economic reasons, the technique of sequential testing has been developed to enable the examination of data at a series of interim analyses. The aim is to stop recruitment to the study as soon as there is sufficient evidence to reach a firm conclusion. In this paper we present the advantages and disadvantages of conducting interim analyses in phase III clinical trials, together with the key steps to enable the successful implementation of sequential methods in this setting. Examples are given of completed trials, which have been carried out sequentially, and references to relevant literature and software are provided.

Why cancer patients choose in-patient complementary therapy in palliative care: a qualitative study at Arokhayasala Hospice in Thailand

Cancer patients often choose complementary and alternative medicine (CAM) in palliative care, often in addition to conventional treatment and without medical advice or approval. Herbal medicines (HM) are the most commonly used type of CAM, but rarely available on an in-patient basis for palliative care. The motivations which lead very ill patients to travel far to receive such therapies are not clear. A qualitative study was therefore carried out to investigate influences on choosing to attend a CAM herbal hospice, to identify cancer patients’ main concerns about end-of-life care. Semi-structured interviews with 32 patients were conducted and analysed using thematic analysis. Patients were recruited from Arokhayasala, a Buddhist cancer hospice in Thailand which provides CAM, in the form of HM, a restricted diet, Thai yoga, deep-breathing exercises, meditation, chanting, Dhamma, laughter and music therapy, free-of-charge. The main factors influencing decision-making were a positive attitude towards HMs and previous use of them, dissatisfaction with conventional treatment, the home environment and their relationships with hospital doctors. Patients’ own perceptions and experiences were more important in making the decision to use CAM, and especially HM, in palliative cancer care than referral by healthcare professionals or scientific evidence of efficacy. Patients were prepared to travel far and live away from home to receive such care, especially as it was cost-free. In view of patients’ previously stated satisfaction with the regime at the Arokhayasala, these findings may be relevant to the provision of in-patient cancer palliative care to other patients.

Protocol for ACCESS: a qualitative study exploring barriers and facilitators to accessing the emergency contraceptive pill from community pharmacies in Australia

Introduction The rate of unplanned pregnancy in Australia remains high, which has contributed to Australia having one of the highest abortion rates of developed countries with an estimated 1 in 5 women having an abortion. The emergency contraceptive pill (ECP) offers a safe way of preventing unintended pregnancy after unprotected sex has occurred. While the ECP has been available over-the-counter in Australian pharmacies for over a decade, its use has not significantly increased. This paper presents a protocol for a qualitative study that aims to identify the barriers and facilitators to accessing the ECP from community pharmacies in Australia. Methods and analysis Data will be collected through one-on-one interviews that are semistructured and in-depth. Partnerships have been established with 2 pharmacy groups and 2 women's health organisations to aid with the recruitment of women and pharmacists for data collection purposes. Interview questions explore domains from the Theoretical Domains Framework in order to assess the factors aiding and/or hindering access to ECP from community pharmacies. Data collected will be analysed using deductive content analysis. The expected benefits of this study are that it will help develop evidence-based workforce interventions to strengthen the capacity and performance of community pharmacists as key ECP providers. Ethics and dissemination The findings will be disseminated to the research team and study partners, who will brainstorm ideas for interventions that would address barriers and facilitators to access identified from the interviews. Dissemination will also occur through presentations and peer-reviewed publications and the study participants will receive an executive summary of the findings. The study has been evaluated and approved by the Monash Human Research Ethics Committee.

Qualitative tools & experimental philosophy

Experimental philosophy brings empirical methods to philosophy. These methods are used to probe how people think about philosophically interesting things such as knowledge, morality, freedom, etc. This paper explores the contribution that qualitative methods have to make in this enterprise. I argue that qualitative methods have the potential to make a much greater contribution than they have so far. Along the way, I acknowledge a few types of resistance that proponents of qualitative methods in experimental philosophy might encounter, and provide reasons to think they are ill-founded.