Overcoming provider barriers to therapeutic drug monitoring of tumour necrosis factor inhibitors for rheumatoid arthritis:a qualitative analysis

ObjectiveTherapeutic drug monitoring (TDM) of tumour necrosis factor-α inhibitors (TNFi), by measuring drug levels and/or anti-drug antibodies, is being considered by various international bodies to improve patient health outcomes and the value of care for people with rheumatoid arthritis. Rheumatology care providers may perceive barriers to adopting TNFi TDM within their own clinical practice, limiting the potential for patients and health care systems to benefit. This study aimed to explore the barriers perceived by rheumatologists that may reduce their uptake of TNFi TDM for rheumatoid arthritis.MethodSemi-structured one-to-one telephone interviews were performed with a convenience sample of senior rheumatologists with experience of managing people with rheumatoid arthritis. The interviews explored the rheumatologists’ understanding of TDM and their beliefs about how it can be integrated into their own routine practice. Interviews were audio recorded, transcribed verbatim and anonymized. Transcripts were coded inductively and barriers to using TNFi TDM were identified by thematic framework analysis.ResultA sample of eleven senior rheumatologists were interviewed. The rheumatologists described five barriers to adopting TNFi TDM in routine practice: (i) observing clinical need; (ii) understanding how testing can improve practice; (iii) insufficient clinical evidence; (iv) insufficient resources to pay for testing; and (v) insufficient capability to deliver testing.ConclusionBarriers to adopting TNFi TDM in routine care settings will restrict the ability for patients to benefit from effective monitoring strategies as they begin to emerge. Strategies to overcome these barriers are suggested which will require a coordinated response from stakeholders across health care systems

Pragmatic, feasibility randomised controlled trial of a recorded mental health recovery narrative intervention: Narrative Experiences Online intervention for informal carers (NEON-C)

IntroductionInformal carers of people with mental health problems often have unmet support needs. Mental health recovery narratives are increasingly accessible but their relevance to, and impact on informal carers has been minimally investigated. The Narrative Experiences Online (NEON) Intervention is a first-in-field intervention which provides informal carers with access to a diverse collection of recorded mental health recovery narratives. The aim of this trial was to examine the feasibility and acceptability of the NEON Intervention on informal carers.MethodsTwo-arm feasibility randomised controlled trial. Carers were randomly assigned to receiving versus not receiving the NEON Intervention. Feasibility aspects investigated included: the acceptability of the intervention and of randomisation, trial processes, engagement rates, recruitment procedures, attrition, sample size estimation, identification of candidate primary and secondary outcomes, and the feasibility to conduct a definitive trial. Qualitative process evaluation was conducted.Findings121 carers were eligible, 54 carers were randomised (intervention: 27, control: 27). Twelve month follow-up data was available for 36 carers. Carers accessed a mean of 25 narratives over a 12-month period and the intervention group, compared with the control group, reported a small effect on hope, and a moderate effect on the presence of meaning in life. Five modifications were recommended to improve the user experience, applicability, and trial processes.DiscussionThe NEON Intervention is feasible and acceptable. Significant refinement of the NEON Intervention and trial processes is required to personalise and ensure applicability to carers. Further feasibility testing is recommended prior to a definitive trial

Assessing the Joint Value of Genomic-Based Diagnostic Tests and Gene Therapies

Gene therapy is an emerging type of treatment that may aim to provide a cure to individuals with a genetic mutation known to be causative of a specific disease. A diagnosis of the causative mutation must precede treatment with a in vivo gene therapy. Both achieving a genomic-based diagnosis and treatment with a gene therapy may result in substantial expenditures for health care systems. Uncertainties around the health care costs, risks, and benefits derived from diagnosis and treatment with a subsequent gene therapy suggests a need for developing an evidence base, underpinned by opportunity cost, to inform if, and how, these health technologies should be introduced into health care systems funded by finite budgets. This article discusses why current methods to evaluate health technologies (decision-analytic model-based cost-effectiveness analysis from the perspective of a health care system over a lifetime time horizon) are appropriate to quantify the costs and consequences of using genomic-based diagnostic tests and gene therapies in combination, rather than as separate interventions, within clinical practice. Evaluating the economic impact of test-and-treatment strategies will ensure that the opportunity cost of these health technologies is quantified fully for decision-makers who are responsible for allocating limited resources in health care systems