Unmet clinical needs in the management of advanced melanoma: findings from a survey of oncologists.

Advanced melanoma is a life-threatening cancer with limited life expectancy. The recent introduction of new targeted systemic therapies has provided clinicians with the means to potentially extend survival for the first time. However, the chance of cure remains very low and treatment-induced toxicity is well described. This qualitative study was undertaken to evaluate clinicians' assessment regarding the key concerns in managing advanced melanoma following the introduction of these new treatments. Three hundred and forty-three oncologists were surveyed online between August and November 2012 (in 11 countries) and March and April 2013 (in an additional country). Analysis of free-text responses identified 23 clinical issues of concern across all countries. Of these, the most common clinical concerns were drug toxicity and tolerability, followed by limited treatment effectiveness and limited treatment options. These results suggest that despite the promise of the two new agents in the field, clinicians are still concerned about the limitations of current treatment options, recognising that there remains a significant unmet need in the treatment of advanced melanoma.

Clinical and economic impact of infusion reactions in patients with colorectal cancer treated with cetuximab.

BACKGROUND: Systemic agents in cancer treatment were often associated with possible infusion reactions (IRs). This study estimated the incidence of IRs requiring medical intervention and assessed the clinical and economic impacts of IRs in patients with colorectal cancer (CRC) treated with cetuximab. PATIENTS AND METHODS: Details on patients with CRC receiving cetuximab in 2004-2006 were extracted from a large USA administrative claims database. IRs were identified based on the occurrence of outpatient treatment, emergency room (ER) visit, and/or hospitalization for hypersensitivity and allergic reactions. Multivariate regressions were used to examine potential risk factors and quantify the economic impact of IRs. RESULTS: A total of 1122 CRC patients receiving cetuximab were identified. The incidence of IRs requiring medical intervention was 8.4%. Sixty-eight percent of the patients had treatment disruptions and 34% discontinued cetuximab treatment. Mean adjusted costs were $13,863 for cetuximab administrations with an IR requiring ER visit or hospitalization and $6280 for those with an IR requiring outpatient treatment, compared with $4555 for those without an IR. CONCLUSIONS: The incidence rate of cetuximab-related IRs requiring medical intervention in clinical practice was found to be higher than rates reported in the product label and clinical trials. The clinical and economic impacts of these IRs are substantial.

The hospital burden of disease associated with bone metastases and skeletal-related events in patients with breast cancer, lung cancer, or prostate cancer in Spain.

Metastatic bone disease (MBD) is the most common cause of cancer pain and of serious skeletal-related events (SREs) reducing quality of life. Management of MBD involves a multimodal approach aimed at delaying the first SRE and reducing subsequent SREs. The objective of the study was to characterise the hospital burden of disease associated with MBD and SREs following breast, lung and prostate cancer in Spain. Patients admitted into a participating hospital, between 1 January 2003 and 31 December 2003, with one of the required cancers were identified and selected for inclusion into the study. The index admission to hospital, incidence of patients admitted and hospital length of stay were analysed. There were 28,162 patients identified with breast, lung and prostate cancer. The 3 year incidence rates of hospital admission due to MBD were 95 per 1000 for breast cancer, 156 per 1000 for lung cancer and 163 per 1000 for prostate cancer. For patients admitted following an SRE, the incidence rates were 211 per 1000 for breast cancer, 260 per 1000 for lung cancer and 150 per 1000 for prostate cancer. This study has shown that cancer patients consume progressively more hospital resources as MBD and subsequent SREs develop.

Cost effectiveness of drotrecogin alfa (activated) for the treatment of severe sepsis in the United Kingdom.

Drotrecogin alfa (activated) is licensed in Europe for the treatment of severe sepsis in patients with multiple organ failure. We constructed a model to assess the cost effectiveness of drotrecogin alfa (activated) from the perspective of the UK National Health Service when used in adult intensive care units. Patient outcomes from a 28-day international clinical trial (PROWESS) and a subsequent follow-up study (EVBI) were supplemented with UK data. Cost effectiveness was assessed as incremental cost per life year and per quality adjusted life year saved compared to placebo alongside best usual care. Applying the 28-day mortality outcomes of the PROWESS study, the model produced a cost per life year saved of 4608 UK pounds and cost per quality adjusted life year saved of 6679 UK pounds. Equivalent results using actual hospital outcomes were 7625 UK pounds per life year and 11,051 UK pounds per quality adjusted life year. Drotrecogin alfa (activated) appears cost effective in treating severe sepsis in UK intensive care units.

Impact of abciximab versus tirofiban on hospital length of stay for PCI patients.

The purpose of this retrospective study was to examine in a naturalistic setting the effect of abciximab versus tirofiban on hospital length of stay for patients undergoing percutaneous coronary intervention (PCI). Retrospective data were obtained from HCIASach's Clinical Pathways Database on 5,560 PCI patients who were administered either abciximab or tirofiban. Multivariate analysis was used to control for a wide range of factors (GPIIb/IIIa selection, patient demographics, insurance provider, health conditions, admission information, and hospital characteristics) that may influence hospital length of stay. Estimation was conducted via a two-stage sample selection model. After controlling for high-risk indications and sources of selection bias, results indicate that receipt of abciximab was associated with significantly shorter lengths of hospital stays compared to tirofiban (1.01 fewer days; p < 0.001). In a subgroup analysis of patients having an acute myocardial infarction (AMI; n = 2,593), receipt of abciximab was also found to be associated with significantly shorter hospital stays compared to tirofiban (0.60 fewer days; p < 0.001). Results of this study indicate that patients who are administered abciximab versus tirofiban have significantly shorter hospital stays. This reduction in length of stay may imply potential cost offsets for PCI patients who receive abciximab.

A comparison of abciximab use in MCO and non-MCO populations.

OBJECTIVE: To compare abciximab use in managed care organization (MCO) patients and non-MCO patients undergoing coronary angioplasty, specifically (1) the factors influencing abciximab use, (2) the impact of abciximab on hospital length of stay (LOS), and (3) differences in results in MCO and non-MCO patients. STUDY DESIGN: A retrospective observational study based on data from 87 US hospitals on 13,384 angioplasty patients. PATIENTS AND METHODS: Multivariate analysis was used to control for a wide range of factors (patient demographics, health conditions, admission information, and hospital characteristics) that may influence the likelihood of receiving abciximab and hospital length of stay (LOS). Estimation was conducted via a 2-stage sample selection model. RESULTS: Comorbidities, hospital characteristics, and geographic regions influenced abciximab use in MCO and non-MCO populations. In the non-MCO population, women and minority group members were significantly less likely than white male patients to receive abciximab. Both MCO and non-MCO angioplasty patients who were given abciximab had significantly shorter LOSs (0.66 +/- 0.27 fewer days and 0.87 +/- 0.13 fewer days, respectively) than did patients who were not given this drug. CONCLUSIONS: Access to care for MCO and non-MCO populations differed. Non-MCO women and minorities were less likely than non-MCO white men to receive abciximab, but this difference was not observed in the MCO population. After controlling for high-risk indications and selection bias, MCO and non-MCO patients who received abciximab had significantly shorter LOSs than did those who did not receive abciximab. This finding is consistent with the many clinical trials that have observed a reduction in ischemic complications associated with abciximab use.

Abciximab provides cost-effective survival advantage in high-volume interventional practice.

BACKGROUND: Placebo-controlled randomized trials of platelet glycoprotein (GP) IIb/IIIa blockade during percutaneous coronary intervention have demonstrated efficacy of these agents for reducing the risk of periprocedural ischemic events. However, cost-effectiveness of this adjunctive pharmacotherapy has been scrutinized. Extrapolation of cost-efficacy observations from clinical trials to "real world" interventional practice is problematic. METHODS: Consecutive percutaneous coronary interventions (n = 1472) performed by Ohio Heart Health Center operators at The Christ Hospital, Cincinnati, Ohio, in 1997 were analyzed for procedural and long-term (6-month) outcomes and charges. Observations on cost and efficacy (survival) were adjusted for nonrandomized abciximab allocation by means of "propensity scoring" methods. RESULTS: Abciximab therapy was associated with a survival advantage to 6 months after percutaneous coronary intervention. The average reduction in mortality rate at 6 months was 3.4% (unadjusted) and 4.9% when adjusted for nonrandomization. The average charge increment to 6 months was $1512 (unadjusted) and $950 when adjusted for nonrandomization. Patients deriving the greatest reduction in mortality rates also had a reduction in total cardiovascular charges to 6 months. Distinguishing demographics of this population included multivessel coronary intervention, coronary stent deployment, intervention within 1 week of myocardial infarction, and lower left ventricular ejection fraction. The average cost per life-year gained in this study was $2875 for all patients (unadjusted) and $1243 when adjusted for nonrandomization. CONCLUSIONS: Abciximab provides a cost-effective survival advantage in high-volume interventional practice that compares favorably with currently accepted standards. Clinical and procedural demographics associated with increased cost-effectiveness included multivessel coronary intervention, stent deployment, recent (<1 week) myocardial infarction, and impaired left ventricular function.

Association between abciximab and length of stay in intensive care for patients undergoing percutaneous coronary intervention. A 2-stage econometric model in a naturalistic setting.

OBJECTIVE: To examine the effect of abciximab treatment on intensive care length of stay for patients undergoing percutaneous coronary intervention (PCI). DESIGN AND SETTING: A retrospective study conducted in a naturalistic setting. METHODS: A 2-stage econometric model was used to control for the influence of possible selection bias across categories of patients and for both observable and unobservable factors correlated with each patient's treatment selection and length of stay in intensive care. Multivariate analysis was applied to control for a wide range of factors (patient demographics, insurance provider, health conditions, admission and discharge information, and hospital characteristics) that may influence intensive care length of stay. Retrospective data were obtained from HCIA's Clinical Pathways Database. PARTICIPANTS: Patients (n = 13,364) who were hospitalised in any of 87 hospitals across the US over the period from October 1, 1995 to December 1, 1996. RESULTS: After controlling for high-risk indications and selection bias, results indicated that administration of abciximab was associated with a significantly shorter length of stay in intensive care compared with not administering a GPIIb/IIIa inhibitor (0.45 fewer days; p < or = 0.0001). In a subgroup analysis of patients having an acute myocardial infarction (n = 4793), administration of abciximab was also associated with a significantly shorter intensive care stay (0.27 fewer days; p < 0.0001). CONCLUSION: Results of this study indicate that the administration of abciximab is associated with a reduction in the length of stay in intensive care. This reduction implies potential cost offsets for patients undergoing PCI who receive abciximab.

Designing naturalistic prospective studies of economic and effectiveness outcomes associated with novel antipsychotic therapies.

The cornerstone of recent pharmacoeconomic work in schizophrenia is the hypothesis that the improved efficacy of novel antipsychotic medications will lead to a reduction in medical services utilization, thereby reducing direct medical costs associated with treatment. Creating the most valid design to prospectively examine the effectiveness and costs of competing pharmacotherapies requires a dialectic of opposing research paradigms. The final protocol must represent a series of decisions that strike a careful balance between being scientifically sound (internal validity) and generalizable to the real world of clinical treatment (external validity). The results must be useful to decision-makers in determining to what extent reductions in healthcare expenditures can offset higher drug acquisition costs within their type of treatment environment. This article is a review of several methodological challenges in the design of medical effectiveness trials, including whether to blind the study, definition of the patient population, degree of physician discretion in treatment, and how to collect and analyze data for patients who discontinue their originally assigned medication. The article also provides a discussion of how clinical practices can inform decisions made to meet these challenges. The issues are illustrated through a prospective study designed to evaluate the cost-effectiveness of the newer antipsychotics in general and olanzapine in particular. Cost-effectiveness studies of novel antipsychotic medications, particularly those with naturalistic designs, will increase in importance as the use of these second-generation agents continues to expand.

Vitamin A: lifesaver for the Third World. AID, private sector to bring it.

PIP: Dr. Nils Daulaire, senior health adviser to the US Agency for International Development (USAID), announced their plan to supplement basic food products with vitamin A which will save millions of children in Third World countries from death and diseases. Vitamin A testing conducted in Nepal and Indonesia resulted to significant reductions in the rate of childhood death. Aside from reducing the death rates from illnesses such as pneumonia, diarrhea, and malaria, vitamin A also decreases the severity of the symptoms. In recognition of these benefits, USAID and other major food and drug companies will soon begin their first vitamin A fortification and distribution projects in India, Nicaragua, and Bangladesh. The plan will also be initiated in Zambia on May 13 with a program to fortify sugar. The US government will allocate $25 million for child survival programs.^ieng

Psychosocial resources, adolescent risk behaviour and young adult adjustment: is risk taking more dangerous for some than others?

Longitudinal analyses examined the extent to which adolescent alcohol use, illegal drug use, and antisocial behaviour predicted adjustment and risk behaviour during young adulthood, and whether psychosocial resources buffered any impact of risk-taking. American adolescents completed questionnaires in Grade 12 and 2 years later (n = 694). Personal and social resources predicted success in occupational, relational, and health domains. High school risk behaviours predicted decreased success in relational domains, and alcohol use predicted higher educational attainment, independent of the relations with psychosocial resources. Interactions of resources with risk behaviours predicting adjustment were inconsistent, but resources predicted decreased risk behaviours in young adulthood among adolescent risk-takers. Discussion focuses on the value of, and challenges to, research on consequences of adolescent risk taking.

The help of formal models for healthcare security policies.

This article is a personal contribution (i.e., from a strict security expert point of view) towards the help for specification, validation and/or evaluation of reliable, but also secure, healthcare security policies (HSP). The first part is dedicated to show, according to the various aspects of the security policy concept, that healthcare information systems (HIS) offer such a diversity of particularities and potential security needs, that it is necessary for healthcare security policies to be defined as flexible, but also as robust, as possible. Then the formal modelling approach, a wide area of solutions providing both flexibility (by means of modelling) and robustness (by means of formalization), is presented. The most well-known examples of security models are recalled. All of them try to use formal models as a security policy specification/validation tool, but none of them can be helpfully used in the very demanding context of HIS. Lastly, a new approach for the modelling of healthcare security policies, based on modal logic (i.e., epistemic and/or deontic logic) is proposed. It permits to take into account the flexibility (by means of high expressiveness due to modality) and the robustness (by means of high provability due to modelling) needs.

Parental psychological control: revisiting a neglected construct.

This article argues for the value in socialization research of focusing explicitly on the construct of parental psychological control of children--control that constrains, invalidates, and manipulates children's psychological and emotional experience and expression. The article traces the history of the construct and distinguishes psychological control theoretically and empirically from more behaviorally oriented control. 2 new measures of psychological control are developed. Data from 3 separate studies are presented which indicate that psychological control can be adequately measured across demographically varied samples and mode of measurement. In both cross-sectional and longitudinal analyses, psychological control, particularly as perceived by preadolescents and adolescents, is consistently predictive of youth internalized problems (depression) and, in some cases, externalized problems (delinquency). In contrast, behavioral control is related primarily to externalized problems.

How to achieve secure environments for information systems in medicine.

The efficiency of modern health care relies more and more upon a computerized infrastructure. Open distributed IT-systems have started to bring professionals together from all around the world. Multimedia applications integrate formerly separated functionalities. On the one hand, easy processing and communication of images, sounds, and texts will help to represent illnesses and diseases holistically. But, on the other hand, such technology may compromise the privacy of patients, and may subvert the accountability and professional secrecy of health care professionals. The European Union has initiated a multi-disciplinary project to come up with practical guidelines on how to achieve a Secure Environment for Information Systems in MEDicine (SEISMED). It has taken into account the traditional and proven principles of health care data processing, the various legislations within the EU, the enormous and subtle risks of health care IT-systems, and the cost of changing existing technology.

Participatory democracy in health care: the role of the responsible citizen.

Health care reform is not just about finding solutions to health care, but about creating, or recreating, a vigorous and resonant sense of what it means to be an American citizen. The first step in health care reform is to create citizens, and you will have everything you need.