BACKGROUND: Venous thromboembolism (VTE) is common in cancer patients and its treatment is associated with a high risk of recurrent VTE (rVTE) and bleeding.
OBJECTIVES: To analyze data from the Comparison of Acute Treatments in Cancer Hemostasis (CATCH) trial to describe the impact of rVTE and bleeding events on health-related quality of life.
METHODS: The three-level EuroQol five-dimensional questionnaire (EQ-5D) data were collected monthly for up to 7 months in patients starting anticoagulation for newly diagnosed VTE. Analyses were designed to describe the impact of rVTE and bleeding on EQ-5D scores while controlling for effects of covariates such as background and clinical variables and longitudinal changes. A repeated-measures model with specification of the variance-covariance matrix to characterize the intrapatient correlation was used to estimate the utility values. The impact of an rVTE or a bleeding event was assumed to be reflected in the utility value when it occurred within 2 weeks from a planned data collection point.
RESULTS: Data were available from 883 patients. A total of 76 rVTE and 159 bleeding events occurred during follow-up. rVTE had a significant impact on EQ-5D scores, with a decrement of -0.075 on the basis of our reference case (male, no metastasis, Eastern Cooperative Oncology Group score = 1, Western European), but different patients might have different decrements. Bleeding events had a smaller (nonstatistically significant) impact on EQ-5D scores.
CONCLUSIONS: This data set study has quantified the decline in EQ-5D scores associated with experiencing rVTE or bleeding events in cancer patients. These results indicate the net gain in quality of life and impact on cost-effectiveness of secondary VTE prevention.
BACKGROUND: Warfarin and direct oral anticoagulants (DOACs) are used for the initial treatment and secondary prevention of venous thromboembolism (VTE), and have similar efficacy. Patient concerns and preferences are important considerations when selecting an anticoagulant, yet these are not well studied.
METHODS: VTE patients (n = 519) were surveyed from online sources (clotconnect.org, stoptheclot.org and National Blood Clot Alliance Facebook followers [n = 495]) and a haematology clinic in Vermont (n = 24).
RESULTS: Patients were 83% females and on average (±standard deviation [SD]) 45.7 ± 13.1 years; 65% self-reported warfarin as their initial VTE treatment and 35% a DOAC. Proportions reporting being extremely concerned about the following outcomes were as follows: recurrent VTE 33%, major bleeding 21%, moderate bleeding 16% and all-cause death 29%. When asked about oral anticoagulant characteristics, patients strongly preferred anticoagulants that are reversible (53%), and for which blood drug levels can be monitored (30%). Lower proportions agreed with statements that regular blood testing is inconvenient (18%), that they are comfortable using the newest drug versus an established drug (15%) and that it is difficult to change their diet to accommodate their anticoagulant (17%). In multivariable-adjusted models, patients tended to have had as their initial treatment, and to currently be taking, the oral anticoagulant option they personally preferred.
DISCUSSION: Patients held the greatest concern for recurrent VTE and mortality, regardless of which treatment they were prescribed. Potential weaknesses of warfarin (e.g., dietary restrictions, regular monitoring) were generally not considered onerous, while warfarin's advantages (e.g., ability to monitor) were viewed favourably.
BACKGROUND: Oral anticoagulation therapy requires regular blood testing to ensure therapeutic levels are maintained and excessive bleeding/clotting is avoided. Technology-assisted self-testing and management is seen as one of the key areas in which quality of care can be improved whilst reducing costs. Nevertheless, levels of patient engagement in self-testing and management remain low. To date, little research emphasis has been placed on understanding the patients' perspectives for low engagement. The typical approach adopted by healthcare providers is to provide patient education programmes, with the expectation that individual patients will change their behaviour and adopt new self-care strategies. However, if levels of patient engagement are to be increased, healthcare providers must also develop a better understanding of how their clinical service provision is perceived by patients and make adaptations.
OBJECTIVE: To explore patient views, needs and expectations of an anticoagulation service and the self-testing and management services provided.
METHODS: Interviews were conducted with 17 patients who currently engage in international normalised ratio (INR) self-testing and management. Thematic coding and analysis were carried out on the interview transcripts.
RESULTS: Four high-level themes emerged from interviews: (i) role of clinic, (ii) motivations for self-testing, (iii) managing INR and (iv) trust. The clinic was seen as adding value in terms of specifying testing frequency, dosage profiles and calibrating equipment. Prompt communication from clinic to patient was also valued, although more personalised/real-time communication would help avoid feelings of isolation. Patients felt more in control as self-tester/managers and often took decisions about treatment adjustments themselves. However, some also manipulated their own test results to avoid 'unnecessary' interventions.
CONCLUSIONS AND RECOMMENDATIONS: More personalised/real-time communication, pragmatic and collaborative patient-clinician partnerships and recognition of expert patient knowledge and expertise are needed if increased levels of engagement with self-testing and management service provision is to be realised.
BACKGROUND: Direct oral anticoagulants (DOACs) are an alternative for vitamin K antagonists (VKA) in the treatment and prevention of venous thromboembolism (VTE). Patient preferences for treatment options have not been extensively explored.
METHODS: A random sample of 200 patients was obtained from those treated with VKA for deep vein thrombosis, pulmonary embolism or both at the Thrombosis Service Amsterdam. Preference for DOACs relative to VKA was assessed using a treatment trade-off technique administered as a questionnaire sent to all patients. The trade-off consisted of four consecutive scenarios: 1 (no need for laboratory control), 2 (decreased bleeding risk), 3 (less interactions with food and other drugs), 4 (higher efficacy).
RESULTS: The response rate was 68%. In scenario 1, 36% of patients would switch to a DOAC. This proportion rises to 57% (odds ratio [OR] 2.3; 95% confidence interval [CI] 1.6-3.3) for scenario 2. Scenario 3 resulted in 64% of patients preferring a DOAC (OR 3.2; 95%CI 2.2-4.6). The advantage of greater efficacy did not result in a noteworthy change in the preference. Patients who were less satisfied with their current treatment, who were younger and those with higher education were more likely to prefer a DOAC over a VKA. The variables gender, treatment duration, and type of VKA were not significantly associated with DOAC preference.
CONCLUSION: Almost two-thirds of patients preferred DOACs over VKA. Patients considered the lack of regular laboratory monitoring, the lower risk of serious bleeding and less interactions with food and other drugs the most important arguments to switch to a DOAC.
OBJECTIVES: Venous thromboembolism (VTE, including deep vein thrombosis [DVT] and pulmonary embolism [PE]) is a serious, potentially traumatic, life-threatening condition and a major cause of mortality and morbidity. The aim of this study was to explore the patients' experiences of VTE and its psychosocial impact.
METHODS: Audio-recorded semistructured interviews with a purposive sample of 12 participants who had experienced a first-time DVT or PE within the previous 6 months. Interviews were transcribed and thematically analysed.
RESULTS: Four key themes with 10 subthemes were identified. The major themes were as follows: VTE as life-changing and traumatic, living with uncertainty and fear of reoccurrence, feeling let down by health services, and positive changes and outcomes. The content of themes varied according to age at the time of VTE and participants' experiences of diagnosis and treatment.
CONCLUSIONS: The data demonstrate the psychosocial impact of VTE as life-changing, encompassing a dynamic duality of trauma and growth. The findings highlight a potential role for health care professionals in identifying and supporting individuals at risk of post-traumatic stress, and targeted interventions to enhance psychological well-being and recovery and reduce distress. Statement of contribution What is already known on this subject? Venous thromboembolism (VTE) is often characterized by sudden onset and may carry a significant threat to life, particularly in the form of pulmonary embolism. Early studies suggest that health-related quality of life is negatively affected by VTE and there is likely to be a high prevalence of trauma. What does this study add? This study explores for the first time the experience of, and reactions to, VTE in the 6 months following its occurrence. It explores the role that psychological well-being can play in recovery after VTE. This study highlights that improvements are needed to support VTE patients to cope with the emotional impact of VTE. A dual process of trauma and post-traumatic growth after VTE is reported for the first time.
INTRODUCTION: Direct oral anticoagulants (DOACs) have shown non-inferiority and ease of use compared to vitamin K antagonists (VKA) in the treatment of venous thromboembolism (VTE). No study so far has been directed toward real-life experience of outpatients receiving anticoagulants for VTE in France.
METHODS: This is an observational descriptive real-life epidemiological study, using three validated questionnaires (Morisky Medication Adherence Scale-8, EQ-5D, and part 2 of the Perception of Anticoagulant Treatment Questionnaire), to assess adherence, quality of life, and satisfaction in 100 VTE outpatients receiving anticoagulation therapy by VKA (primary or switched from DOAC to VKA) or by DOAC (primary or switched from VKA to DOAC).
RESULTS: Patients were very much satisfied with their treatment in both DOAC and VKA groups. Despite advantages of DOACs, therapeutic adherence was only moderate. The best adherence scores were observed in the primary VKA switched to DOAC for at least 3 months (S-DOAC) subgroup. Quality of life was better in the DOAC group mainly because of the absence of the requirement for blood testing. Most of the complaints concerned the pain/discomfort dimension in the VKA group and anxiety/depression dimension in the DOAC group.
CONCLUSION: Patients were satisfied with their anticoagulant treatment, especially when they were involved in choosing the anticoagulant, and the treatment suited them. Quality of life of patients in the DOAC group was better than in the VKA group, but adherence remains to be improved. This study highlights the importance of the physician-patient relationship, pretreatment initiation, and follow-up of any anticoagulation therapy throughout.
BACKGROUND: In a randomized trial (ie, Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer [CLOT]) that evaluated secondary prophylaxis of recurrent venous thromboembolism (VTE) in patients with cancer, dalteparin reduced the relative risk by 52% compared to oral vitamin K antagonists (VKAs; hazard ratio = 0.48, P = .002). A recent subgroup analysis in patients with moderate to severe renal impairment also revealed lower absolute VTE rates with dalteparin (3% vs 17%; P = .011). To measure the economic value of dalteparin in these populations, a pharmacoeconomic analysis was conducted from the Dutch health-care system perspective.
METHODS: Resource utilization data contained within the CLOT trial database were extracted and converted into direct cost estimates. Univariate analysis was then conducted to compare the total cost of therapy between patients randomized to dalteparin or VKA therapy. Health state utilities were then measured in 24 members of the general public using the time trade-off technique.
RESULTS: When all of the cost components were combined for the entire population (n = 676), the dalteparin group had significantly higher overall costs than the VKA control group (dalteparin = €2375 vs VKA = €1724; P < .001). However, dalteparin was associated with a gain of 0.14 (95% confidence interval [CI]: 0.10-0.18) quality-adjusted life years (QALYs) over VKA. When the incremental cost was combined with the utility gain, dalteparin had a cost of €4,697 (95% CI: €3824-€4951) per QALY gained.
CONCLUSION: Secondary prophylaxis with dalteparin is a cost-effective alternative to VKA for the prevention of recurrent VTE in patients with cancer.
OBJECTIVE: To examine patients' understanding of hospital-associated thrombosis, and their experiences of thromboprophylaxis.
DESIGN: Qualitative study using semi-structured interviews with 31 patients requiring venous thromboembolism (VTE) prophylaxis following a recent hospital admission. Interviews were audio-recorded, transcribed verbatim and analysed thematically using framework analysis.
SETTING: 4 hospitals in Birmingham and Oxford.
RESULTS: All the participants received thromboprophylaxis following surgical procedures. Participants were aware of a risk of blood clots; however, they lacked a good understanding of VTE and its components. Experiences of VTE prophylaxis were characterised with good adherence to heparin injections and poor adherence to elastic compression stockings, largely due to perceived lack of clarity in guidance from health professionals. Participants had limited knowledge of the signs and symptoms of VTE and would value improved education on VTE.
CONCLUSIONS: Findings suggest that patient education is often inadequate and impacts negatively on patients' involvement in VTE prevention. An enhanced patient education programme incorporating a consistent message on the appropriate use of elastic compression stockings and description of VTE symptoms is likely to optimise the effectiveness of the prevention of hospital-associated thrombosis. Physicians may use the results of this study to improve individual patient education.
