Patient-Led Urate Self-Monitoring to Improve Clinical Outcomes in People With Gout: A Feasibility Study.

OBJECTIVE: Self-monitored point-of-care urate-measuring devices are an underexplored strategy to improve adherence to urate-lowering therapy and clinical outcomes in gout. This study observed patient-led urate self-monitoring practice and assessed its influence on allopurinol adherence, urate control, and health-related quality of life. METHODS: People with gout (n = 31) and prescribed allopurinol self-monitored their urate concentrations (HumaSens2.0plus) at baseline and thereafter monthly for 12 months (3 months per quarter). Adherence to allopurinol was measured using medication event monitoring technology (Medication Event Monitoring System cap). Time spent below the target urate concentration (<0.36 mmol/L) was determined. Health-related quality of life was measured using a survey (EuroQoL EQ-5D-5L). Gout flares were recorded. Two-tailed Spearman correlation and the Wilcoxon matched-pairs signed-rank test (P < 0.05) were used for statistical comparisons. RESULTS: Most participants were male (94%) and had urate concentrations below the target (74%) at baseline. Overall, seven participants demonstrated repeated periods of "missed doses" (two or fewer allopurinol doses missed consecutively) and "drug holidays" (three or more missed doses). Most participants (94%) persisted with allopurinol. Time spent within the target urate concentration increased 1.3-fold (from 79% to 100%; P = 0.346), and the incidence of gout flares decreased 1.6-fold (from 8 to 5; P = 0.25) in the final quarter compared to that in the first quarter of the study. Health-related quality of life was reduced for participants reporting at least one gout flare (median utility values 0.9309 vs 0.9563, P = 0.04). CONCLUSION: Patient-led urate self-monitoring may support the maintenance of allopurinol adherence and improve urate control, thus reducing the incidence of gout flares. Further research on patient-led urate self-monitoring in a randomized controlled study is warranted.

Estimation of adherence to urate-lowering therapy in people living with gout using Australia's Pharmaceutical Benefits Scheme and patient-reported dosing.

AIMS: The aim of this study was to estimate adherence to urate-lowering therapy (ULT), predominately allopurinol, from Australia's Pharmaceutical Benefits Scheme (PBS) claims database in association with (1) patient-reported doses and (2) World Health Organization's (WHO) defined daily doses (DDD), namely, allopurinol (400 mg/day) or febuxostat (80 mg/day). METHODS: Proportion of days covered (PDC) was calculated in 108 Gout App (Gout APP) trial participants with at least two recorded ULT dispensings in an approximately 12-month period before provision of intervention or control apps. Adherence was defined as PDC ≥80%. We measured the correlation between the two methods of calculating PDC using a Wilcoxon signed rank test. Agreement between ULT-taking status (self-reports) and ULT-dispensed status (PBS records) was tested with Cohen's kappa (κ), and positive and negative percent agreement. RESULTS: Allopurinol was prescribed in 93.5% of participants taking ULT. Their self-reported mean daily dose (SD) was 291 (167) mg/day. Mean PDC (SD) for allopurinol was 83% (21%) calculated using self-reported dose, and 63% (24%) using WHO's DDD. Sixty-three percent of allopurinol users were identified as adherent (PDC ≥80%) using self-reported dose. There was good agreement between self-reported ULT use and PBS dispensing claims (κ = 0.708, P < .001; positive percent agreement = 90%, negative percent agreement = 82%). CONCLUSIONS: Participant-reported allopurinol daily doses, in addition to PBS dispensing claims, may enhance confidence in estimating PDC and adherence compared to using DDD. This approach improves adherence estimations from pharmaceutical claims datasets for medications where daily doses vary between individuals or where there is a wide therapeutic dose range.

Patient factors and health outcomes associated with illness perceptions in people with gout.

OBJECTIVE: Illness perceptions are views and beliefs formed in response to a health threat which may influence self-management behaviours and chronic disease outcomes. Despite effective medication, sub-optimal outcomes in gout are common. This study aimed to quantitatively investigate illness perceptions in gout to examine how illness perceptions relate to health outcomes. METHODS: Data were obtained from a randomised-controlled trial where people with gout (n = 493) completed surveys measuring illness perceptions (Brief Illness Perception Questionnaire (B-IPQ)), gout flares, medication adherence, health-related quality of life, healthcare utilisation and productivity, alongside serum urate blood tests at baseline, 6- and 12-month follow-ups. Multivariable linear regression identified patient factors independently associated with each B-IPQ item score. Logistic and linear regression, adjusted for age and sex, determined whether baseline B-IPQ items could predict current and future health outcomes. RESULTS: Younger individuals and those with severe gout were more likely to experience pessimistic illness perceptions at baseline. Optimistic illness perceptions were associated with lower odds of having at least one flare in the preceding 6 months. Every 1-point increase in B-IPQ treatment control, indicating the optimistic view that gout is treatable, decreased the odds of a recent flare prior to baseline by 33% (OR : 0.67; 95%CI : 0.53,0.85; p< 0.001) and prior to 12-month follow-up by 15% (OR : 0.85; 95%CI : 0.76,0.96; p= 0.01). Pessimistic illness perceptions also predicted poorer medication adherence, health-related quality of life and productivity but not serum urate levels. CONCLUSION: Modifying pessimistic illness perceptions, including, but not limited to, patient education, may promote prudent self-management behaviours and better outcomes in gout. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry; https://www.anzctr.org.au/; ACTRN12616000455460.

Global Prevalence of Anxiety in Adult Cardiology Outpatients: A Systematic Review and Meta-analysis.

Anxiety and anxiety disorders are associated with adverse cardiovascular outcomes, and reduced quality of life. Despite this, no comprehensive study on the global prevalence of anxiety symptoms and disorders among adult cardiology outpatients exists. This systematic review and meta-analysis aims to provide cardiologists with a precise estimate of the prevalence of anxiety in their outpatient clinics. PubMed, Embase, Cochrane and PsycINFO databases and Google Scholar were searched from database inception to January 23, 2023. Data characteristics were extracted independently by 2 investigators. Ninety-three studies, n = 36,687 participants across 31 countries, were included. Global prevalence of anxiety symptoms/disorders was 28.9% (95%CI 25.7-32.4; 8927/36, 687; I2 = 97.33; n = 93). The highest rates were found in patients presenting with hypertension, 43.6%. Subgroup analyses revealed higher prevalence estimates when using self-report screening compared to gold-standard diagnostic interview. When using diagnostic interview, the highest rates were reported in outpatients with undifferentiated chest pain/palpitations, 19·0%. Panic disorder was the most frequent diagnosis 15.3%, and rates were significantly higher in patients with undifferentiated chest pain/palpitations compared to ischemic heart disease. Higher rates of anxiety were found in studies of outpatients from developing countries, and female outpatients tended to have higher rates compared to males. Anxiety occurred frequently among cardiology outpatients and at a higher rate than estimated in the general population. Given the impact anxiety has on patient outcomes, it is important that effective identification and management strategies be developed to support cardiologists in identifying and treating these conditions in their clinics.

Optimizing adherence to allopurinol for gout: patients' perspectives.

AIMS: Poor adherence to allopurinol among people with gout contributes to suboptimal gout management. This study sought to understand the facilitators and barriers to allopurinol adherence across the three stages of medication adherence, and patient perspectives on strategies to improve adherence, including self-monitoring urate concentration. METHODS: Semi-structured interviews were conducted with 26 people with gout, previously or currently taking allopurinol. De-identified verbatim transcripts were thematically analysed using an inductive and deductive approach. RESULTS: Facilitators of adherence during allopurinol initiation were motivation to prevent gout flares and trust in the advice of their healthcare professionals (HCPs). Reluctance to commence long-term medication was a barrier to allopurinol initiation. Believing in the effectiveness and necessity of allopurinol and reminder systems were facilitators of implementation. Barriers to implementation included forgetfulness, gout flares and limited feedback on allopurinol's effectiveness. Patients discontinued therapy when allopurinol was perceived as ineffective or unnecessary. Discontinuation coincided with patients experiencing gout flares while adhering to allopurinol and receiving suboptimal advice about gout management. Patients identified receiving accurate advice from HCPs and regular urate monitoring for feedback on allopurinol's effectiveness as potential strategies to improve adherence. Perceived benefits of self-monitoring urate as a strategy to promote adherence included the ability to self-manage gout and make informed decisions about allopurinol therapy with their HCP. CONCLUSION: Patient perceptions of the effectiveness and necessity of allopurinol influenced intentional adherence during medication initiation, implementation and discontinuation. Strategies that inform patients of their urate control and provide accurate medical advice have the potential to improve adherence to allopurinol.

Persistence with urate-lowering therapy in Australia: A longitudinal analysis of allopurinol prescriptions.

AIM: Gout is the most common form of inflammatory arthritis in men. Despite the availability of effective urate-lowering therapies (ULT), the management of gout is suboptimal due to poor persistence with ULT. This study examined national prescribing patterns of ULT to determine persistence with allopurinol in Australia. METHODS: A 10% sample of the Australian Pharmaceutical Benefits Scheme dispensing claims database was used to identify individuals initiated on allopurinol between April 2014 and December 2019. The number of allopurinol scripts dispensed was used to estimate persistence with allopurinol. Persistence was defined as the number of months from initiation until discontinuation (last prescription with no further scripts acquired for a period thereafter). Kaplan-Meier curves were used to examine persistence, while Cox regression analysis was used to examine the influence of gender, concomitant colchicine and age. RESULTS: The largest drop in persistence occurred immediately after initiation, with 34% of patients discontinuing allopurinol 300-mg therapy in the first month. Median persistence with allopurinol 300 mg was 5 months (95% confidence interval 4.76-5.24), with around 63% of individuals not persisting with this therapy for more than 12 months. Concomitant prescription of colchicine on the day of allopurinol initiation only occurred in 7% of allopurinol initiations. No increase in persistence was observed for those co-prescribed colchicine. CONCLUSION: Persistence with allopurinol was poor. More effective methods targeting prescribers, patients and systems are required to promote persistence with allopurinol. Improving persistence to allopurinol is an important public health goal given the proven potential of this medication to eliminate gout.

Rebranding Gout: Could a Name Change for Gout Improve Adherence to Urate-Lowering Therapy?

Gout is the most common form of inflammatory arthritis in men, yet both patients and the public often do not recognise gout as a form of arthritis. Instead, due to historical misconceptions, gout is typically seen as a lifestyle disease caused by poor diet. In reality, there are a number of risk factors that contribute to gout, including genetic factors. Views of gout as precipitated by lifestyle alone can lead to stigma, and maladaptive beliefs that it should be treated primarily through dietary changes. This is thought to contribute to poor uptake of, and adherence to, effective pharmaceutical treatments. Gout has some of the poorest medication adherence rates of any chronic disease, contributing to suboptimal health outcomes for patients. Recent research suggests that when gout is referred to as 'urate crystal arthritis' (a rarely used name for gout), the perception of the disease by members of the public was more accurate. It was viewed as being less under personal control (i.e. less appropriately managed by behaviours such as dietary intake), and more appropriately managed by long-term medical treatment. This finding raises the possibility that patients themselves might also benefit from gout being explicitly labelled as arthritis. Indeed, parallels can be drawn between this case and other diseases that have recently had their names changed to improve outcomes, namely primary biliary cirrhosis and schizophrenia. A movement away from the term gout may benefit those living with the disease by changing illness perceptions and increasing uptake of, and adherence to, guideline-recommended treatment(s).

Placebo and Active Treatment Additivity in Placebo Analgesia: Research to Date and Future Directions.

Placebo analgesia is a robust experimental and clinical phenomenon. While our understanding of the mechanisms of placebo analgesia has developed rapidly, some central questions remain unanswered. Among the important questions is how placebo analgesia interacts with active analgesic effects. It is an assumption underlying double-blind randomized placebo-controlled trials (RCTs) that the true effect of a treatment can be determined by examining the effect of the active treatment arm and subtracting the response in the placebo group ("the assumption of additivity"). However, despite the importance of this assumption for the interpretation of RCTs, it has rarely been formally examined. This article reviews the assumption of additivity in placebo analgesia by examining studies employing factorial designs manipulating both the receipt of an active analgesic and instructions about the treatment being delivered. In reviewing the literature, we identified seven studies that allowed a test of additivity. Of these, four found evidence against additivity, while the remaining three studies found results consistent with additivity. While the limited available data are somewhat mixed, the evidence suggests that at least under some conditions the assumption of additivity does not hold in placebo analgesia. The concordance between mechanisms of the active analgesic and placebo analgesia may influence whether additivity occurs or not. However, more research using factorial designs is needed to disentangle the relationship between placebo analgesia and the active effect of analgesic treatments.

Placebo Analgesia From a Rubber Hand.

Placebo analgesia, reductions in pain after administration of an inert treatment, is a well documented phenomenon. We report, to our knowledge, the first demonstration that placebo analgesia can be experienced when a sham analgesic is applied onto a rubber hand. The effect was obtained by exploiting the rubber hand illusion, in which ownership is felt over a rubber arm that is unattached to the body. Under conditions of synchronous as well as asynchronous visuotactile stimulation, a thermal pain stimulus was delivered on the real arm of 20 participants and seemingly also on the rubber arm, before and after applying a sham analgesic and a control cream only to the rubber arm. During synchronous visuotactile stimulation, pain was experienced on the rubber arm, and the application of the sham analgesic to the rubber arm significantly decreased the severity of reported pain. This shows that experience of the body can modulate expectations and the induction of placebo analgesia. PERSPECTIVE: This article presents an experiment suggesting that a placebo treatment applied to a rubber hand during the rubber hand illusion can produce placebo analgesia. This finding indicates that embodiment may influence the placebo effect, a previously unexamined factor in the treatment process with potential applications to treatment administration.