BackgroundRenal transplantation (RT) is considered the treatment of choice for end-stage renal disease compared to dialysis, offering better health-related quality of life (HRQoL) and higher survival rates. However, immunosuppressants are essential for the long-term survival of kidney grafts and patients’ non-adherence to their medication leads to poor outcomes. Immunosuppressants can also significantly alter patients’ HRQoL because of their side effects and the complex chronic medication regimen they represent.PurposeTo elicit key concepts related to adherence to immunosuppressant therapy (IT) and reasons for non-adherence in terms of patient reported outcomes, side effects, and the impact of the medication on HRQoL in RT population, including patient preference of once daily over twice-daily immunosuppressive regimen. Results were used to develop an IT-specific conceptual framework and provide suggestions for improving patients’ adherence to IT.Materials and methodsInterviews were conducted with three clinical experts to determine key concepts related to RT and immunosuppressants. Thirty-seven participants in four focus groups were asked to cite important concepts related to adherence and impact of IT on HRQoL and to rate them. Qualitative analysis was conducted to code participants’ responses.ResultsNon-adherence among participants where admitted was unintentional. The reason for this included forgetfulness, interference with lifestyle, being asleep at the time the medication should be taken, change in routine, and impact of side effects. Overall, participants reported that the evening dose was more problematic to remember and that the exclusion of this dose could make them more adherent. Participants also reported that IT impacted on their HRQoL in a number of ways including: placing restrictions on their lifestyle, causing anxiety, or impairing their ability to work.ConclusionThis study provides qualitative evidence about the barriers to IT adherence and the components of HRQoL that are important from the perspective of RT patients. The developed conceptual framework of IT-HRQoL in RT transplants, including social, psychological, and work life domains, can be used to inform the development of a new IT-specific measure of HRQoL in RT patients for use in head-to-head clinical trials or observational studies. Despite limitations associated with the number and the age range of patients recruited, this study suggests that a change in the regimen from twice-daily to once daily among other measures could improve their adherence to IT and their HRQoL by placing less restrictions on their lifestyles.

Objectives: Adherence to immunosuppressive therapy after kidney transplantation is crucial to avoid graft rejection and optimise long term patient and graft survival. However, patient's adherence is not always optimal. Our aim was to identify reasons for non-adherence and health-related quality of life (HRQoL) dimensions affected by immunosuppressant therapy (IT) after kidney transplantation (KT) including patient preference of once daily over twice daily immunosuppressive regimen. MethOds: A literature review on adherence to immunosuppressant therapy (IT) and impact of IT on HRQoL through the EMBASE database was performed. Interviews were conducted with 2 clinical experts to determine key concepts related to KT and immunosuppressants. Thirty-six patients in four focus groups were asked to cite important concepts related to adherence and impact of IT on HRQoL and rate them. Qualitative analysis was conducted to code patient's responses. Results:The results showed that non-adherence was mostly unintentional among the participants. The reason for non-adherence included forgetfulness, interference with lifestyle, being asleep at the time the medication should be taken, change in routine and impact of side effects. The twice daily regimen was more problematic in relation to adherence. Overall, participants were of the opinion that a once daily IT regimen would help them be more adherent. Also, IT impacts on the HRQoL of the patient in a number of ways including: restricting the patients' lifestyle, causing anxiety or impairing the patient's ability to work. Although the patients happily oblige to the necessity of taking IT medication, patients preferred to reduce the burden associated with medication. cOnclusiOns: This study suggested that patients strongly valued adherence to IT medication and saw a change in the regimen from twice daily to once daily as one way to improve their adherence to IT. Results also suggested that a once daily regimen could improve patient's HRQoL.Objectives: Although pivotal studies of overactive bladder (OAB) medications routinely use micturition frequency (MF) when defining the primary or coprimary endpoint, few studies have examined minimal important difference (MID) values for this parameter. This study explored MID values for MF using data from a Phase IIb study in OAB patients with urge predominant incontinence along with estimates for OAB symptoms of urinary urgency (UU), urgency incontinence (UUI), and total incontinence (TI). MethOds: The endpoint was defined as the change from baseline to 8 weeks in the number of daily episodes averaged over a diary week for each parameter. Anchor-and distribution-based methods using statistical criteria (e.g. half standard deviation) were used to estimate MID ranges for all diary parameters. Anchors were selected as a +1 change score representing slight improvement for global assessment questions assessing frequency and control over OAB symptoms. Results: The sample included 769 OAB patients with (80.4%) and without (19.6%) incontinence. The bas...

OBJECTIVES: Clostridium difficile infection (CDI) can lead to several complications from mild diarrhoea to toxic megacolon. The objectives of this study were to: 1) evaluate standard Time trade-off (TTO) and chain TTO techniques for eliciting utility of CDI-related chronic and temporary health states; 2) compare those values with those from Healthcare Professional (HCP) EQ-5D valuation; 3) evaluate methods of calculating utilities for health states worse than death (WTD). METHODS: Ten health state vignettes were developed from literature with input from HCPs. Participants from the UK public were interviewed: 50 for the pilot and 100 for the main study. Each participant provided sociodemographic information, ranking of health states by preference and responses to a Computer-Assisted Personal Interview TTO protocol for all states considered. HCPs provided EQ-5D data. Methods to apprehend the impact of extreme negative utilities were appraised: truncation and monotonic transformation. RESULTS: Temporary health state utilities ranged from (mean and (/) median from non transformed method; mean and median (/) from monotonically transformed method): -2.70/0.7;0.39/0.6 for mild diarrhoea to -32.50/-1.1; -0.23/-0.5 for colectomy. Chronic health state ranged from: -2.37/0.5; 0.35/0.5 for chronic diarrhoea to -7.98/0;-0.13/0 for chronic renal failure. Population valuations were more severe for most health states when compared with HCP values. CONCLUSIONS: While transformation has an important impact on results, nowadays there is no reliable measure of utilities for CDI-health states. The proportion of participants judging health states as WTD was unexpectedly high; questioning the suitability of face-to-face TTO interview in this disease area. The monotonic transformation was convenient but lacks theoretical grounding. Other methods like Lead Time trade-off could add value to similar research.