Cancer patients are at risk of developing blood clots in their veins - venous thromboembolism (VTE) - which often takes the form of a pulmonary embolism or deep vein thrombosis. The risk increases with advanced disease. Evidence based treatment is low molecular weight heparin (LMWH) by daily subcutaneous injection. The aim of this research is to explore the barriers for doctors in the UK when diagnosing and treating advanced cancer patients with VTE.
Qualitative, in-depth interview study with 45 doctors (30 across Yorkshire, England and 15 across South Wales). Doctors were from three specialties: oncology, palliative medicine and general practice, with a mixture of senior and junior staff. Framework analysis was used.
Doctors opinions as to whether LMWH treatment was ethically appropriate for patients who were symptomatic from VTE but at end of life existed on a shifting continuum, largely influenced by patient prognosis. A lack of immediate benefit coupled with the discomfort of a daily injection had influenced some doctors not to prescribe LMWH. The point at which LMWH injections should be stopped in patients at the end of life was ambiguous. Some perceived ‘overcaution’ in their own and other clinicians’ treatment of patients. Viewpoints were divergent on whether dying of a PE was considered a “good way to go”. The interventionalism and ethos of palliative medicine was discussed.
Decisions are difficult for doctors to make regarding LMWH treatment for advanced cancer patients with VTE. Treatment for this patient group is bounded to the doctors own moral and ethical frameworks.
Venous thromboembolism; Heparin; Low-molecular-weight; Palliative care; Qualitative research; Ethics; Medical
A cornerstone of American medical ethics is the right to say, “Keep your hands off of me,” to decline medical treatment. A central problem is how to decide about individuals who have become incapacitated and can no longer request or refuse potentially life-sustaining treatment. An advance directive is a formal attempt to protect people’s right to autonomy when they are no longer autonomous. As such, it assumes that previously expressed wishes are precise and immutable, but many families make decisions together, and individuals may negotiate, compromise, and modify their genuine preferences, especially when novel threats arise, and the stakes are high. The current article describes a case in which two daughters overruled a patient’s explicit preference to refuse life-sustaining treatment, leading to burdensome illness before death. In the end, the mother seemed to understand her children’s needs and seemed willing, at least in retrospect, to have met those needs. After the death of this individual, we continued to talk with the daughters and videotaped an interview in which they shared their perspectives on the case. The daughters consented to be videotaped and to share the video with the medical community (available in online version of article). Their forceful devotion to their mother and their search in retrospect for what could have been done differently has completely changed our understanding of events. We believe that the daughters’ behavior is not the indefensible breach of respect for person that it seemed to be. Their mother’s true wishes might well have included a desire to help her children during her own dying. Family members’ preferences are likely to be important considerations for many people, although the possibility of coercion has to be acknowledged as well. Accommodating this level of decision-making complexity is highly problematic for our understanding of advance directives.
Low-molecular-weight heparin (LMWH) is recommended and commonly used for extended treatment of cancer-associated thrombosis (CAT), but its superiority over warfarin has been demonstrated in only one randomised study. We report here the rationale, design and a priori analysis plans of Comparison of Acute Treatments in Cancer Haemostasis (CATCH; NCT01130025), a multinational, Phase III, open-label, randomised controlled trial comparing tinzaparin with warfarin for extended treatment of CAT.
The primary objective is to assess the efficacy of tinzaparin in preventing recurrent venous thromboembolism (VTE) in patients with active cancer and acute, symptomatic proximal deep vein thrombosis and/or pulmonary embolism. The secondary objectives are to determine: safety of tinzaparin given over 6 months; clinical and laboratory markers for recurrent VTE and/or major bleeding; 6-month overall mortality; incidence and severity of post-thrombotic syndrome; patient-reported quality of life; and healthcare resource utilisation. Nine hundred patients are randomised to receive tinzaparin 175 IU/kg once daily for 6 months or initial tinzaparin 175 IU/kg once daily for 5–10 days and dose-adjusted warfarin (target INR 2.0–3.0) for 6 months. The primary composite outcome is time to recurrent VTE, including incidental VTE and fatal pulmonary embolism. All patients are followed up to 6 months or death, whichever comes sooner. Blinded adjudication will be performed for all reported VTE, bleeding events and causes of death. Efficacy will be analysed using centrally adjudicated results of all patients according to intention-to-treat analysis. An independent Data Safety Monitoring Board is reviewing data at regular intervals and an interim analysis is planned after 450 patients have completed the study.
The results will add significantly to the knowledge of the efficacy, safety and cost effectiveness of tinzaparin in the prevention of recurrent VTE in patients with cancer and thrombosis. Prospective data will emerge on the clinical significance of incidental VTE and risk stratification in patients with CAT. Results on post-thrombotic syndrome, quality of life and healthcare resource utilisation will inform decision makers on how to secure better patient care. If tinzaparin is shown to be more effective than warfarin, CATCH will provide valuable confirmatory data to support the use of the LMWH tinzaparin for extended treatment of CAT.
Venous thromboembolism; Cancer; LMWH; Tinzaparin; Warfarin; CATCH; Recurrent; Symptomatic; Incidental; Health-related quality of life
Venous thromboembolism (VTE) occurs when blood clots in the leg, pelvic or other deep vein (deep vein thrombosis) with or without transport of the thrombus into the pulmonary arterial circulation (pulmonary embolus). VTE is common in patients with cancer and is increased by surgery, chemotherapy, radiotherapy and disease progression. Low molecular weight heparin (LMWH) is routinely used to treat VTE and some evidence suggests that LMWH may also have an anticancer effect, by reduction in the incidence of metastases. The FRAGMATIC trial will assess the effect of adding dalteparin (FRAGMIN), a type of LMWH, to standard treatment for patients with lung cancer.
The study design is a randomised multicentre phase III trial comparing standard treatment and standard treatment plus daily LMWH for 24 weeks in patients with lung cancer. Patients eligible for this study must have histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell) within 6 weeks of randomisation, be 18 or older, and must be willing and able to self-administer 5000 IU dalteparin by daily subcutaneous injection or have it administered to themselves or by a carer for 24 weeks. A total of 2200 patients will be recruited from all over the UK over a 3 year period and followed up for a minimum of 1 year after randomisation. Patients will be randomised to one of the two treatment groups in a 1:1 ratio, standard treatment or standard treatment plus dalteparin. The primary outcome measure of the trial is overall survival. The secondary outcome measures include venous thrombotic event (VTE) free survival, serious adverse events (SAEs), metastasis-free survival, toxicity, quality of life (QoL), levels of breathlessness, anxiety and depression, cost effectiveness and cost utility.
Current Controlled Trials ISRCTN80812769
Patients with cancer are at high risk of developing venous thromboembolism (VTE), including deep venous thrombosis and pulmonary embolism. Compared to non-cancer patients, VTE in cancer is more frequently associated with clinical consequences, including recurrent VTE, bleeding, and an increase in the risk of death. Low-molecular-weight heparins (LMWHs) are commonly recommended for the prevention and treatment of VTE in cancer patients because of their favorable risk-to-benefit profile. Indeed, compared with vitamin K antagonists, LMWHs are characterized by a reduced need for coagulation monitoring, few major bleeding episodes, and once-daily dosing, which make these drugs more suitable in the cancer setting. Guidelines have been published recently with the aim to improve the clinical outcomes in cancer patients at risk of VTE and its complications. Coagulation activation in cancer may have a role not only in thrombosis but also in tumor growth and dissemination. Hence, inhibition of fibrin formation has been considered a possible tool against the progression of malignant disease. Clinical studies show that anticoagulant drugs may have a beneficial effect on survival in cancer patients, with a major role for LMWHs. Recently a number of prospective randomized clinical trials to test LMWHs to improve cancer survival as a primary endpoint in cancer patients have been conducted. Although the results are controversial, the interest in this research area remains high.
venous thromboembolism; VTE; LMWH
Low molecular weight heparin (LMWH) is in vast usage for treatment of thromboembolic diseases such as deep venous thrombosis and acute coronary syndromes. There are certain clinical situations where a quick point of care testing of the effect of LMWH would be useful. At this point there are no point of care devices available in the market for monitoring the effect of LMWH. Thrombelastography (TEG) evaluates the viscoelastic properties of blood during coagulation. The clinical application of TEG in monitoring LMWH treatment is not yet well defined. The purpose of this in vivo study was to systematically evaluate the most suitable TEG parameters for evaluation of the antithrombotic effect of LMWH. We furthermore evaluated for the first time the usefulness of the composite TEG parameter the Thrombodynamic Ratio (TDR) in monitoring LMWH treatment.
Healthy male volunteers (n = 7) were injected subcutaneously with the LMWH dalteparin 120 IU/kg. TEG parameters and antifactor Xa levels were measures at baseline, 2, 4, 5 and 24 hours after the injection. Correlation between TEG parameters and antiXa were calculated. The sensitivity and specificity of the TEG parameters for plasma levels of antiXa in the therapeutic range of 0.5 - 1.0 U/ml were calculated.
All basic TEG parameters correlated significantly with antiXa levels. Among the basic parameters, the TEG reaction time R had the best correlation with antiXa levels with the most favorable combination of sensitivity and specificity for the therapeutic range of antiXa levels (r = 0.82, p < 0.0001, sensitivity 68%, specificity 100%). The composite TEG parameter TDR demonstrated the best correlation with antiXa levels, and an even more favorable combination of sensitivity and specificity compared to any of the basic parameters (r = - 0.87, p < 0.0001, sensitivity 95%, specificity 79%).
The TEG reaction time R and TDR are the most suitable TEG parameters for evaluation of the antithrombotic effect of dalteparin with a highly significant correlation with antiXa levels in healthy male volunteers. Measures for uniform clinical use of these parameters are proposed. Larger clinical trials are needed to correlate R and TDR with clinical outcomes.
Venous thromboembolism is a common disease that is associated with considerable morbidity if left untreated. Recently, low-molecular-weight heparins (LMWHs) have been evaluated for use in acute treatment of deep venous thrombosis and pulmonary embolism. Randomized studies have shown that LMWHs are as effective as unfractionated heparin in the prevention of recurrent venous thromboembolism, and are as safe with respect to the occurrence of major bleeding. A pooled analysis did not show substantial differences among different LMWH compounds used, but no direct comparison of the different LMWHs is currently available. Finally, in patients with pulmonary embolism, there is a relative lack of large studies of daily practice. It could be argued that large prospective studies, in patients who were treated with LMWHs from the moment of diagnosis, are needed.
low-molecular-weight heparins; pulmonary embolism; treatment; venous thrombosis
Changes in the hemostatic system and chronic hemostatic activation are frequently observed in patients with cancer, even in the absence of venous thromboembolism (VTE). VTE is a leading cause of death among patients with cancer and contributes to long-term mortality in patients with early as well as advanced-stage cancer. Mounting evidence suggests that components of the clotting cascade and associated vascular factors play an integral part in tumor progression, invasion, angiogenesis, and metastasis formation. Furthermore, there are intriguing in vitro and animal findings that anticoagulants, in particular the low molecular weight heparins (LMWHs), exert an antineoplastic effect through multiple mechanisms, including interference with tumor cell adhesion, invasion, metastasis formation, angiogenesis, and the immune system. Several relatively small randomized controlled clinical trials of anticoagulation as cancer therapy in patients without a VTE diagnosis have been completed. These comprise studies with LMWH, unfractionated heparin, and vitamin K antagonists, with overall encouraging but nonconclusive results and some limitations. Meta-analyses performed for the American Society of Clinical Oncology VTE Guidelines Committee and the Cochrane Collaboration suggest overall favorable effects of anticoagulation on survival of patients with cancer, mainly with LMWH. However, definitive clinical trials have been elusive and questions remain regarding the importance of tumor type and stage on treatment efficacy, the impact of fatal thromboembolic events, optimal anticoagulation therapy, and safety with differing chemotherapy regimens. Although the LMWHs and related agents hold promise for improving outcomes in patients with cancer, additional studies of their efficacy and safety in this setting are needed.
Cancer and its therapies increase the risk of venous thromboembolism. Compared to patients without cancer, patients with cancer anticoagulated for venous thromboembolism are more likely to develop recurrent thrombotic events and major bleeding. Addressing all important outcomes including harm is of great importance to make evidence based health care decisions. The objective of this study was to compare low molecular weight heparin (LMWH) and oral anticoagulants (vitamin K antagonist (VKA) and ximelagatran) for the long term treatment of venous thromboembolism in patients with cancer.
A systematic review of the medical literature. We followed the Cochrane Collaboration methodology for conducting systematic reviews. We assessed methodological quality for each outcome by grading the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology.
Eight randomized controlled trials (RCTs) were eligible and reported data for patients with cancer. The quality of evidence was low for death and moderate for recurrent venous thromboembolism. LMWH, compared to VKA provided no statistically significant survival benefit (Hazard ratio (HR) = 0.96; 95% CI 0.81 to 1.14) but a statistically significant reduction in venous thromboembolism (HR = 0.47; 95% (Confidence Interval (CI) = 0.32 to 0.71). There was no statistically significant difference between LMWH and VKA in bleeding outcomes (RR = 0.91; 95% CI = 0.64 to 1.31) or thrombocytopenia (RR = 1.02; 95% CI = 0.60 to 1.74).
For the long term treatment of venous thromboembolism in patients with cancer, LMWH compared to VKA reduces venous thromboembolism but not death.
Advanced pancreatic cancer, in addition to its high mortality, is characterized by one of the highest rates of venous thromboembolic events (VTE) as compared to other types of cancer. Enoxaparin, a low molecular weight heparin (LMWH), has proven to be effective for the prevention and treatment of VTE in surgical and general medical patients. Results of some small studies suggest that this benefit might extend to patients with cancer, however, enoxaparin is not currently indicated for this use. This phase IIb study was designed to analyze the efficacy of enoxaparin in patients with locally advanced or metastatic pancreatic cancer undergoing systemic chemotherapy.
The aim of this prospective multicenter trial is to compare concomitant treatment with enoxaparin to no anticoagulation in 540 patients. Primary endpoint is the incidence of clinically relevant VTE (symptomatic deep venous thrombosis (DVT) of the leg and/or pelvic and/or pulmonary embolism (PE)) within the first 3 months. Secondary endpoints include the incidence of symptomatic and asymptomatic VTE after 6, 9 and 12 months as well as remission at 3, 6, 9 and 12 months, overall survival and bleeding. Trial registration: isrctn.org identifier CCT-NAPN-16752, controlled-trials.com identifier: ISRCTN02140505.
An interim analysis for safety performed after inclusion of 152 patients revealed no increased risk of bleeding (5 pts vs. 6 pts, Chi2: 0.763).
PROSPECT is a pivotal study in elucidating the role of low molecular weight heparins in advanced pancreatic cancer. Its results will lead to a new understanding of the role of heparins in the prevention of venous thromboembolism and of their effect on survival, remission rates and toxicity of chemotherapeutic regimens.
BACKGROUND: Acute deep vein thrombosis has traditionally been treated with unfractionated heparin (UFH), administered intravenously, but low-molecular-weight heparins (LMWH), administered subcutaneously, have recently become available. The authors sought to determine which therapy was more cost-effective for inpatient and outpatient treatment of deep vein thrombosis. METHODS: An incremental cost-effectiveness analysis based on a decision tree was performed for 4 treatment strategies for deep vein thrombosis. Rate of major hemorrhage while receiving heparin, rate of recurrence of venous thromboembolism 3 months after treatment and mortality rate 3 months after treatment were determined by meta-analysis. Costs for the UFH therapy were prospectively collected by a case-costing accounting system for 105 patients with deep vein thrombosis treated in fiscal year 1995/96. The costs for LMWH therapy were modelled, and cost-effectiveness was determined by decision analysis. RESULTS: Meta-analysis revealed a mean difference in risk of hemorrhage of -1.1% (95% confidence interval [CI] -2.4% to 0.3%), a mean difference in risk of recurrence of venous thromboembolism of -2.6% (95% CI -4.5% to -0.7%) and a mean difference in risk of death of -1.9% (95% CI -3.6% to -0.4%), all in favour of subcutaneous unmonitored administration of LMWH. The cost to treat one inpatient was $2993 for LMWH and $3048 for UFH. Even more would be saved if LMWH was delivered on an outpatient basis (cost of $1641 per patient). The cost-effectiveness analysis showed that LMWH in any treatment setting is more cost effective than UFH. A sensitivity analysis demonstrated the robustness of this conclusion. INTERPRETATION: Treatment of deep vein thrombosis with LMWH is more cost effective than treatment with UFH in both inpatient and outpatient settings.
How humans think and make decisions is important in understanding behaviour. Hence an understanding of cognitive processes among physicians may inform our understanding of behaviour in relation to evidence implementation strategies. A personality theory, Cognitive-Experiential Self Theory (CEST) proposes a relationship between different ways of thinking and behaviour, and articulates pathways for behaviour change. However prior to the empirical testing of interventions based on CEST, it is first necessary to demonstrate its suitability among a sample of healthcare workers.
To investigate the relationship between thinking styles and the knowledge and clinical practices of doctors directly involved in the management of acute coronary syndromes.
Self-reported doctors' thinking styles (N = 74) were correlated with results from a survey investigating knowledge, attitudes, and clinical practice, and evaluated against recently published acute coronary syndrome clinical guidelines.
Guideline-discordant practice was associated with an experiential style of thinking. Conversely, guideline-concordant practice was associated with a higher preference for a rational style of reasoning.
Findings support that while guidelines might be necessary to communicate evidence, other strategies may be necessary to target discordant behaviours. Further research designed to examine the relationships found in the current study is required.
With the growing use of low-molecular-weight heparins (LMWH) for the treatment and prevention of venous thromboembolism (VTE), it is important to provide an evidence-based comparison with unfractionated heparin (UFH) concerning rates of heparin-induced thrombocytopenia (HIT). Such comparisons are essential in clinical decision-making and cost-modeling. In this paper we review data regarding non-surgical (medical) patients. We conclude that the lack of uniform evaluation and standardized testing for HIT in the current literature precludes making a reliable estimate of the relative risk of HIT in UFH vs. LMWH in either the treatment or prevention of VTE in non-surgical patients. However, current data suggest that the risk of thrombocytopenia and HIT is low and similar for non-surgical patients who receive either LMWH or UFH.
Thrombosis is a common complication in patients with cancer and it is estimated that about 20% of patients with cancer experience venous thromboembolism (VTE). This complication is associated with high rate of morbidity and mortality and is sometimes the first manifestation of an occult cancer. The risk profiles and markers involved in cancerassociated thrombosis share similarities with inflammation-induced atherosclerosis and thrombosis. The type of cancer, chemotherapy, surgery, central venous catheters, pre-chemotherapy platelet and leukocyte count are associated with high risk of VTE in cancer patients. Landmark studies demonstrated that effective prophylaxis and treatment of VTE reduced morbidity and increased survival. Low-molecular-weight heparin (LMWH) is preferred as an effective and safe means for prophylaxis and treatment of VTE. It has largely replaced unfractionated heparin and vitamin K antagonists. The advantages of LMWH include increased survival and quality of life, decreased rate of VTE, low incidence of thrombocytopenia. New guidelines for prophylaxis and treatment are now available and prophylaxis is recommended in hospitalized cancer patients and patients undergoing major surgery. Treatment with LMWH should be considered as the first line of therapy for established VTE and to prevent recurrent thrombosis in patients with cancer.
Cancer; Thrombosis; Low-molecular-weight heparin.
Background and Objectives:
Deep vein thrombosis (DVT) occurs at a lower rate in Asia than in the rest of the world. We wanted to study the significance and efficacy of low molecular weight heparin (LMWH) in prophylaxis of DVT in major general surgical patients in the Kashmir Valley (India, Asia) so as to make it a routine in our patients.
Patients and Methods:
This was a prospective study in which the effect of LMWH was compared with no prophylaxis.
LMWHs are more effective than no prophylaxis in the prevention of DVT and pulmonary thromboembolism in highest-risk general surgical patients (odds ratio = 16.64; 95% confidence interval = 3.63–1130.03; P-value = 0.014).
LMWHs have a significant prophylactic effect on DVT in general surgical patients, with a higher benefit to risk ratio, and, in spite of the low incidence of DVT in Asia, its prophylaxis should routinely be considered in this part of the world as well, preferably in the form of LMWHs.
Heparin; prophylaxis; thrombosis
Traditionally, acute deep venous thrombosis (DVT) is treated with intravenous heparin followed by oral anticoagulants. With the advent of the low-molecular-weight heparins (LMWHs), this strategy is changing dramatically. LMWHs are compounds derived from standard unfractionated heparin that offer distinct clinical advantages over unfractionated heparin, including better bioavailability, longer half-life, and a more predictable anticoagulant response that obviates the need for laboratory monitoring. The common side effects of unfractionated heparin, including bleeding, thrombocytopenia, and osteoporosis, may be less common with LMWH. For the treatment of established venous thromboembolism, LMWH is at least as safe and effective as unfractionated heparin. Recent studies demonstrate that home therapy of DVT with LMWH, compared with inpatient therapy with unfractionated heparin, produces comparable clinical outcomes and patient satisfaction, with dramatic cost savings. With careful patient selection, home therapy of venous thromboembolism is quickly becoming the new standard of care.
Evidence-based treatment guidelines recommend low molecular weight heparin monotherapy for cancer-associated venous thromboembolism (VTE). This analysis assessed the first-line treatment strategies for VTE in patients with advanced solid tumors and found that only 25% of patients received guideline-recommended low molecular weight heparin. Future studies should explore reasons underlying the underutilization of this preferred evidence-based treatment as well as the comparative effectiveness of low molecular weight heparin versus warfarin-based anticoagulation in real-world cancer patients with VTE.
Evidence-based treatment guidelines recommend low molecular weight heparin (LMWH) monotherapy for cancer-associated venous thromboembolism (VTE). This analysis assessed the first-line treatment strategies for VTE in patients with advanced solid tumors.
Using administrative data from advanced lung, prostate, colon, or breast cancer patients diagnosed between January 2000 and December 2007 at four HMOs with integrated delivery systems, patients with an inpatient or outpatient VTE diagnosed within 2 years after cancer diagnosis and an outpatient purchase of warfarin, LMWH, and/or fondaparinux anticoagulant within 7 days of the VTE diagnosis were identified. First-line outpatient VTE pharmacological treatment and factors independently associated with receipt/non-receipt of LMWH monotherapy were assessed.
Overall, 25% of the 1,089 eligible patients received LMWH monotherapy as primary VTE treatment. The percentage increased steadily over time from 18% among patients diagnosed in 2000 to 31% among those diagnosed in 2007. Factors associated with LMWH monotherapy included VTE diagnosis year, chemotherapy within 60 days prior to VTE diagnosis, history of VTE prior to cancer diagnosis, and invasive surgery in the 90 days following VTE diagnosis. Colorectal and prostate cancer patients versus lung cancer patients and stage III versus stage IV patients were less likely to be treated with LMWH monotherapy.
Adoption of LMWH monotherapy as initial treatment for cancer-associated VTE was low but increased steadily over the study period. Future studies should explore reasons underlying the underutilization of this preferred evidence-based treatment as well as the comparative effectiveness of LMWH versus warfarin-based anticoagulation in real-world cancer patients with VTE.
Venous thromboembolism; Anticoagulants; Neoplasms; Ambulatory care
Patients may bring unreliable information to the physician, complicating the physician–patient relationship, or outside information seeking may complement physician information provision, reinforcing patients’ responsibility for their health. The current descriptive evidence base is weak and focuses primarily on the Internet's effects on physician–patient relations. This study describes how cancer patients bring information to their physicians from a range of sources and are referred by physicians to these sources; the study also examines explanations for these behaviors. Patients with breast, prostate, and colon cancer diagnosed in 2005 (N = 1,594) were randomly drawn from the Pennsylvania Cancer Registry; participants returned mail surveys in Fall 2006 (response rate = 64%). There is evidence that both bringing information to physicians and being referred to other sources reflects patients’ engagement with health information, preference for control in medical decision making, and seeking and scanning for cancer-related information. There is also evidence that patients who bring information from a source are referred back to that source.
The improved support of complex medical decision making will require a greater understanding of the cognitive processes of physicians. Decision making in medicine often involves the careful weighing of uncertain and ill-structured information from various sources. In this paper a cognitive approach to analyzing complex intensive care decision making is outlined. The study described involved the presentation of case descriptions of systematically varied complexity, to two levels of physicians: intensive care residents (intermediates) and intensive care specialists (experts). Subjects were asked to "think aloud" in providing treatment and management decisions for the cases. The audiotaped protocols were then analyzed for the use of decision strategies and for key aspects of decision making. It was found that expert subjects tended to focus on developing a more refined situational analysis of the decision problem. The study results are being used in the design of a system for aiding physicians in making complex decisions in intensive care medicine.
Thromboembolism, including both venous and arterial events, occurs commonly amongst patients with cancer. The occurrence of thromboembolism has significant consequences for cancer patients, including direct and indirect associations with mortality, morbidity, requirement for long-term anticoagulant therapy and consumption of healthcare resources. Recent studies have resulted in a better understanding of clinical risk factors and biomarkers of cancer-associated thrombosis, and a risk assessment model incorporating both has now been validated in multiple settings. Thromboprophylaxis with either unfractionated heparin or low-molecular-weight heparins (LMWHs) has been shown to be safe and effective in high-risk settings such as hospitalization for medical illness and the post-surgical period. Emerging new data from randomized studies have focused on outpatient prophylaxis, suggesting potential benefits in this setting as well. Treatment of cancer-associated thrombosis requires long-term anticoagulation with LMWH. Results from ongoing and planned trials of novel anticoagulants in the cancer setting are awaited.
venous thromboembolism; prevention; treatment; risk factors; cancer
A new approach to continuing medical education by distance learning has been implemented. A series of six patient-management problems or challenges were posted to 20 000 doctors throughout Britain. Each doctor had to decide on the diagnosis, investigations, and treatment of the patients described. The challenges covered problems that were important in the doctor's day-to-day work and were designed so that he could obtain immediate feedback about his decisions and compare his own responses with those of a specialist and those of his colleagues. Additional information was available by telephone and by post on request. The series has been well received and is being widely used.
OBJECTIVES: To gain insight into the reasons behind and the prevalence of doctors' decisions at the end of life that might hasten a patient's death ("end of life decisions") in institutions caring for mentally handicapped people in the Netherlands, and to describe important aspects of the decisions making process. DESIGN: Survey of random sample of doctors caring for mentally handicapped people by means of self completed questionnaires and structured interviews. SUBJECTS: 89 of the 101 selected doctors completed the questionnaire. 67 doctors had taken an end of life decision and were interviewed about their most recent case. MAIN OUTCOME MEASURES: Prevalence of end of life decisions; types of decisions; characteristics of patients; reasons why the decision was taken; and the decision making process. RESULTS: The 89 doctors reported 222 deaths for 1995. An end of life decision was taken in 97 cases (44%); in 75 the decision was to withdraw or withhold treatment, and in 22 it was to relieve pain or symptoms with opiates in dosages that may have shortened life. In the 67 most recent cases with an end of life decision the patients were mostly incompetent (63) and under 65 years old (51). Only two patients explicitly asked to die, but in 23 cases there had been some communication with the patient. In 60 cases the doctors discussed the decision with nursing staff and in 46 with a colleague. CONCLUSIONS: End of life decisions are an important aspect of the institutionalised care of mentally handicapped people. The proportion of such decisions in the total number of deaths is similar to that in other specialties. However, the discussion of such decisions is less open in the care of mental handicap than in other specialties. Because of distinctive features of care in this specialty an open debate about end of life decisions should not be postponed.
Most cancer patients in westernised countries now want all information about their situation, good or bad, and many wish to be involved in decision-making. The attitudes to and use of shared decision-making (SDM) by cancer doctors is not well known. Australian cancer clinicians treating breast, colorectal, gynaecological, haematological, or urological cancer were surveyed to identify their usual approach to decision-making and their comfort with different decision-making styles when discussing treatment with patients. A response rate of 59% resulted in 624 complete surveys, which explored usual practice in discussing participation in decision-making, providing information, and perception of the role patients want to play. Univariate and multivariate analyses were performed to identify predictors of use of SDM. Most cancer doctors (62.4%) reported using SDM and being most comfortable with this approach. Differences were apparent between reported high comfort with SDM and less frequent usual practice. Multivariate analysis showed that specialisation in breast or urological cancers compared to other cancers (AOR 3.02), high caseload of new patients per month (AOR 2.81) and female gender (AOR 1.87) were each independently associated with increased likelihood of use of SDM. Barriers exist to the application of SDM by doctors according to clinical situation and clinician characteristics.
shared decision-making; doctor specialty; doctor discipline; treatment decisions
Background: This study describes cognitive processes of doctors who are deciding on the treatment for a patient. This helps to uncover how prescribing decisions could benefit from (computerised) support.
Methods: While thinking aloud, 61 general practitioners made prescribing decisions for five patients with urinary tract infections or stomach complaints. The resulting 305 transcripts were analysed to determine the scope and nature of the decision processes. Differences in the process were related to case or doctor characteristics, and to differences in the quality of prescribing behaviour.
Results: The decision processes were not extensive, particularly for patients with a urinary tract infection. The doctors did not actively consider all possible relevant information. Considerations referring to core aspects of the treatment were made in 159 cases (52%) and to contextual aspects in 111 cases (36%). Habitual behaviour, defined as making a treatment decision without any specific contemplation, was observed in 118 cases (40%) and resulted in prescribing first choice as well as second choice drugs. For stomach complaints, second choice drugs were often prescribed after considering other treatments or in view of specific circumstances. Experience of the doctor was not related to the type of decision process.
Conclusions: The processes observed deviate from the decision theoretic norm of thoroughly evaluating all possible options, but these deviations do not always result in suboptimal prescribing. Decision support is useful for bringing pertinent information and first choice treatments to the prescriber's attention. In particular, information about relevant contraindications, interactions, and costs could improve the quality of prescribing.
Patients undergoing major orthopedic surgery, total hip arthroplasty (THA) and total knee arthroplasty (TKA) are at high risk of venous thromboembolism, manifesting as deep vein thrombosis or pulmonary embolism. The recommended pharmacologic treatment options for thromboprophylaxis after major orthopedic surgery include the vitamin K antagonists (VKAs eg, warfarin), low molecular weight heparins (LMWHs; eg, enoxaparin) and the synthetic pentasaccharide fondaparinux. Most clinics use some kind of thromboprophylaxis routinely. However, due to the frequent need for coagulation monitoring (VKAs) and subcutaneous injections (LMWHs and fondaparinux) barriers exist to prescribing prophylaxis after discharge from hospital. Targeting specific components of the coagulation cascade has yielded several new antithrombotic agents for use as thromboprophylaxis after THA or TKA. Two of these, dabigatran etexilate and rivaroxaban, have already reached the markets in the European Union member states and Canada. Both are administered by the oral route, once-daily fixed dose and without the need to monitor the anticoagulant effect. Whether these new drugs facilitate guideline adherence, particularly in the outpatient settings and thereby improve the overall clinical outcomes remains to be shown.
dabigatran etexilate; rivaroxaban; thromboprophylaxis; total joint arthroplasty; venous thromboembolism