Patients' preferences regarding the timing of highly active antiretroviral therapy initiation for chronic asymptomatic HIV-1 infection.

OBJECTIVE: In patients with a chronic asymptomatic HIV-1 infection and >200 CD4+ T-cells/microl, the optimal timing of highly active antiretroviral therapy (HAART) initiation is unclear. It involves a trade-off between a potentially reduced risk of mortality, when started earlier in the course of infection, and an earlier exposure to pill burden and potential toxicities. We investigated patients' preferences for immediate HAART initiation relative to delaying HAART for 1 year. METHODS: Consecutive patients were asked for their preference during an interview. A hypothetical difference in 3-year mortality risk between both options was systematically varied between 0% and 10% to determine the threshold at which preference would switch to HAART initiation. RESULTS: About 30% of patients preferred HAART initiation even if the mortality risk would be equal for both options. Almost 25% always preferred delaying HAART even if this would result in a 10% greater mortality risk. Most treatment guidelines recommend delaying HAART >350 CD4+ T-cells/microl. However, at a risk difference between starting and delaying HAART that corresponds with this CD4+ T-cell count, about 50% would prefer to start HAART immediately. Most guidelines recommend starting HAART below 200 CD4+ T-cells/microl. However, at a risk difference between both options corresponding with this CD4+ T-cell count, about 40% preferred delaying HAART. CONCLUSIONS: We found large variation in patients' preferences. Some patients were more inclined to initiate HAART earlier than the recommended guidelines, whereas others were more inclined to delay HAART. These findings emphasize the need for shared decision-making when deciding on the most optimal timing of HAART initiation in chronic asymptomatic HIV-1 infection.

Quality of life and the duration of treatment with vitamin K antagonists in patients with deep venous thrombosis.

In clinical practice, decisions on the duration of treatment with vitamin K antagonists are usually based on the presence of persistent risk factors, the risk of bleeding and centre policy. Little is known about the influence of patients' experienced quality of life. The objectives of this study were: 1). to explore the course of quality of life in patients with venous thrombosis treated for 3 months versus patients treated for 6 months with vitamin K antagonists; 2). to investigate the factors that were associated with the duration of treatment with vitamin K antagonists. The study sample comprised patients participating in a multi-centre clinical trial. Quality of life was assessed at study entry, after 10-14 days, 3 and 6 months in 360 patients. Overall, no differences in quality of life were found between the 2 patient groups. An interaction effect between group and time was found for physical functioning. Regression analyses indicated that the presence of one or more permanent risk factors, duration of hospitalisation, mobility prior to deep-vein thrombosis and study centre were associated with the duration of treatment with vitamin K antagonists. Interestingly, quality of life was not associated with treatment duration. Since study centre was the most important factor associated with treatment duration, local policy appears to have a great influence on decisions regarding the duration of treatment with vitamin K antagonists.

Treatment of venous thromboembolism with vitamin K antagonists: patients' health state valuations and treatment preferences.

Determining the optimal duration of vitamin K antagonist (VKA) therapy for patients with venous thromboembolism (VTE) requires a weighting of the benefits and risks of treatment. The objectives of our study were to investigate patient variability in health state valuations associated with VKA therapy and treatment preferences, and to investigate the extent to which valuations and treatment preferences are associated with prior experience with these health states and other patient characteristics. Valuations of outcomes after VTE scaled from 0 (tantamount to death) to 1 (tantamount to perfect health) were elicited from 53 patients who had experienced VTE, 23 patients who had experienced major bleeding during treatment, and 48 patients with the post-thrombotic syndrome. In addition, patients' treatment preferences were evaluated using treatment trade-off questions. Median health state valuations ranged from 0.33 for 'non-fatal haemorrhagic stroke' to 0.96 for 'no VKA treatment'. Variability between patients was substantial. Patients' treatment preferences also varied: 25% of patients chose cessation of treatment, regardless of the probability of recurrent VTE presented, whereas 23% of patients were never willing to choose cessation of treatment. Differences in valuations and treatment preferences were not associated with type of event experienced. Due to the substantial and unpredictable variability in valuations and treatment preferences, recommendations regarding treatment duration should be tailored to patients' specific values and concerns.

A comparison of 3 valuation methods for temporary health states in patients treated with oral anticoagulants.

BACKGROUND: The application of the time tradeoff (TTO) method in temporary health states may lead to less valid results because an unrealistic scenario is presented to patients. The chained TTO has been proposed to solve this problem. OBJECTIVES: To compare a chained TTO method with a conventional TTO method in the valuation of temporary health states, in terms of consistency and reliability. To compare both TTO methods with direct rating. PATIENTS AND METHODS: Eighty-four patients treated with oral anticoagulants were interviewed twice. During the 1st interview, values for 5 temporary health states were obtained with a rank ordering procedure, direct rating, and the chained TTO method. During the 2nd interview, either the 1st interview was repeated (n = 30) or health state values were obtained with the conventional TTO method (n = 54). Consistency was assessed by comparing the 3 valuation methods with the rank ordering procedure. Generalizability theory was used to assess reliability. RESULTS: The 3 methods produced significantly different valuations of health states. Chained TTO values were higher than values obtained with direct rating and the conventional TTO. Consistency and reliability did not differ across the 3 methods. CONCLUSION: The authors found no evidence for a difference in consistency and reliability between the chained TTO method and the conventional TTO method in the valuation of temporary health states. As direct rating is simpler to administer than both TTO methods, one could consider using direct ratings for the valuation of temporary health states. Biases associated with the conventional and the chained TTO method are discussed.

Intervention to improve adherence to lipid-lowering medication and lipid-levels in patients with an increased cardiovascular risk.

Low levels of statin adherence may compromise treatment outcomes. The aim of this study was to investigate whether nurse-led cardiovascular risk-factor counseling could improve statin adherence and lipid levels without increasing patients' anxiety. Patients with indications for statin therapy for primary or secondary prevention of cardiovascular disease were randomly assigned to receive routine care or extended care (EC) at baseline and at months 3, 9, and 18. Patients in the EC group received a personalized risk-factor passport, showing modifiable and unmodifiable individual risk factors and a graphical presentation of their calculated absolute 10-year cardiovascular disease risk as well as the target risk that could be reached if all modifiable risk factors were optimally treated. Lipid levels were assessed at each visit. Carotid intima-media thickness was measured at baseline and at month 18. Adherence, anxiety, quality of life, symptoms, and smoking status were assessed using a self-administered questionnaire at each visit. A total of 201 patients were included in the study. Statin adherence was significantly higher (p <0.01) and anxiety was significantly lower (p <0.01) in the EC group than in the routine care group. Low-density lipoprotein cholesterol was statistically significantly lower in the EC group than in the routine group (2.66 vs 3.00 mmol/L, respectively, p = 0.024) in primary prevention patients only. Intima-media thickness improved significantly from baseline (p <0.01) in all patients, irrespective of group assignment. In conclusion, cardiovascular risk-factor counseling resulted in improved lipid profiles in primary prevention patients and higher levels of adherence to statins and lower levels of anxiety in all patients.

Self-reported adherence is more predictive of virological treatment response among patients with a lower tendency towards socially desirable responding.

BACKGROUND: Self-report is the most commonly used measure of adherence to highly active antiretroviral therapy, but typically shows weaker associations with virological treatment outcome than more objective adherence assessment methods. Socially desirable responding might hamper the validity of self-reported adherence. We investigated whether stratifying patients according to their socially desirable response set might improve the prediction of virological treatment response by self-reported adherence. METHODS: Patients enrolled in the focus group of the Dutch national cohort ATHENA completed a social desirability scale, four self-report adherence questions, and had their plasma HIV type-1 (HIV-1) RNA concentrations measured. We calculated odds ratios and 95% confidence intervals for self-reported non-adherence to predict HIV-1 RNA>50 copies/ml among patients with a lower or a higher tendency towards socially desirable responding. RESULTS: A total of 331 patients were included. Self-reported non-adherence was significantly predictive of HIV-1 RNA>50 copies/ml on three out of four questions among patients with lower socially desirable responding (n=198). Self-reported non-adherence did not predict HIV-1 RNA>50 copies/ml among patients with higher socially desirable responding (n=132). CONCLUSIONS: Stratifying patients according to their socially desirable response set improved the prediction of virological treatment response by self-reported adherence. This finding emphasizes the importance of discussing medication adherence with patients in a non-threatening and non-judgemental way that normalizes non-adherence in order to reduce socially desirable responding.