Paula A. Rochon

Investigator experiences with financial conflicts of interest in clinical trials

BackgroundFinancial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.MethodsEmail survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source.Results844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials.ConclusionFull adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.

Fall Risk Care Processes in Nursing Home Facilities

OBJECTIVEnTo explore the relationships between fall risk factors and care plan intervention and implementation.nnnDESIGNnObservational cohort study.nnnSETTINGnNursing homes in Central Ontario, Canada.nnnPARTICIPANTSnResidents (n = 635) of 8 nursing homes across Ontario, Canada.nnnMEASUREMENTSnChart reviews and observational rounds on nursing units were carried out to examine how well nursing staff (1) identified fall risk, (2) documented nursing care plan interventions, and (3) implemented nursing care plan interventions in residents who had fallen in the preceding year.nnnRESULTSnOf the 635 fallers, two thirds (65.9%) had a history of falls. A total of 94 fallers across the 8 facilities had no fall risk care plan included in their medical record, despite having fallen previously. Only 63.46% of nursing care plan interventions were successfully implemented. Shorter length of stay (P < .001; odds ratio [OR] 0.09; 95% confidence interval [CI] 0.04-0.23), fall history (P = .002; OR 2.14; 95% CI 1.32-3.46), and those who are widowed (P = .001; OR 2.53; 95% CI 1.43-4.48) and divorced (P = .03; OR 2.16; 95% CI 1.06-4.40) predicted a higher likelihood of falls.nnnCONCLUSIONnThis study revealed significant breakdowns in care related to the lack of documented care plan interventions for residents with a history of falls, and lack of implementation in cases where care plan interventions were made. Policies and procedures to improve the selection and implementation of care plan interventions may result in substantial improvements in nursing home safety.

Characteristics of Older Adults Hospitalized in Acute Psychiatric Units in Ontario: A Population-Based Study

Objective: As the numbers of older adults in Canada increases, there will be a growing need for mental health services for this population. Acute psychiatric units (APUs) provide inpatient psychiatric services for the management of serious mental illness. Understanding the characteristics of older adults in APUs is necessary to determine the range of inpatient services required for this population. Method: We conducted a population-based study of all adults discharged from APUs in Ontario in a 2-year period, 2008–2010, using administrative databases. We compared the characteristics of older adults (aged 66 years and older) in APUs to those of younger adults (aged 18 to 65 years), including sociodemographics, psychiatric and medical diagnoses, and measures of cognition and functioning. Results: There were a total of 79 352 discharges from APUs, with older adults accounting for 8.8% of all discharges. Depressive disorder was the most common diagnosis, both in older and in younger populations (32.1% and 29.9%, respectively), while dementia accounted for 19.5% of discharges for older adults. Older adults, compared with younger adults, were more likely to have 2 or more chronic medical conditions (83.8% and 20.5%, respectively), significant cognitive impairment (47.0% and 14.5%, respectively), and moderate-to-severe functional impairment (21.8% and 3.3%, respectively). Conclusions: Older adults in APUs are a complex group, with mental health and medical care needs that differ from younger adults. APUs must be able to provide adequate psychiatric, medical, and interprofessional services to achieve optimal outcomes. Future studies are required to understand the quality of care and outcomes for older adults in APUs.

An Ecological Approach to Reducing Potentially Inappropriate Medication Use: Canadian Deprescribing Network

Polypharmacy is growing in Canada, along with adverse drug events and drug-related costs. Part of the solution may be deprescribing, the planned and supervised process of dose reduction or stopping of medications that may be causing harm or are no longer providing benefit. Deprescribing can be a complex process, involving the intersection of patients, health care providers, and organizational and policy factors serving as enablers or barriers. This article describes the justification, theoretical foundation, and process for developing a Canadian Deprescribing Network (CaDeN), a network of individuals, organizations, and decision-makers committed to promoting the appropriate use of medications and non-pharmacological approaches to care, especially among older people in Canada. CaDeN will deploy multiple levels of action across multiple stakeholder groups simultaneously in an ecological approach to health system change. CaDeN proposes a unique model that might be applied both in national settings and for different transformational challenges in health care.

Antipsychotic Use in Dementia: Is There a Problem and Are There Solutions?

Antipsychotics are necessary for many older adults to treat major mental illnesses or reduce distressing psychiatric symptoms. Current controversy exists over the role of antipsychotics in the management of neuropsychiatric symptoms (NPS) in persons with dementia. Although some NPS may be appropriately and safely treated with antipsychotics, a fine balance must be achieved between the benefits of these medications, which are often modest, and adverse events, which may have significant consequences. Approximately one-third of all persons with dementia are currently prescribed antipsychotic medications, and there is significant variation in the use of antipsychotics across care settings and providers. Reducing the inappropriate or unnecessary use of antipsychotics among persons with dementia has been the focus of increasing attention owing to better awareness of the potential problems associated with these medications. Several approaches can be used to curb the use of antipsychotics among persons with dementia, including policy or regulatory changes, public reporting, and educational outreach. Recently, there has been encouraging evidence of a downward trend in the use of antipsychotics in many long-term care settings, although prescribing rates are still higher than what is likely optimal. Although reducing the inappropriate use of antipsychotics is a complex task, psychiatrists can play an important role via the provision of clinical care and research evidence, contributing to improved care of persons with dementia in Canada and elsewhere.

Unveiling a Prescribing Cascade in an Older Man

thrombosis and pulmonary embolism: The Worcester Venous Thromboembolism Study. Arch Intern Med 2008;168:425–430. 8. Park B, Messina L, Dargon P et al. Recent trends in clinical outcomes and resource utilization for pulmonary embolism in the United States: Findings from the nationwide inpatient sample. Chest 2009;136:983–990. 9. Wei R, Anderson R, Curtin L et al. U.S. decennial life tables for 1999– 2001: United States life tables. Natl Vital Stat Rep 2008;57:1–36. 10. Monreal M, Lopez-Jimenez L. Pulmonary embolism in patients over 90 years of age. Curr Opin Pulm Med 2010;16:432–443.

Immediate financial impact of computerized clinical decision support for long-term care residents with renal insufficiency: a case study

In a randomized trial of a clinical decision support system for drug prescribing for residents with renal insufficiency in a large long-term care facility, analyses were conducted to estimate the systems immediate, direct financial impact. We determined the costs that would have been incurred if drug orders that triggered the alert system had actually been completed compared to the costs of the final submitted orders and then compared intervention units to control units. The costs incurred by additional laboratory testing that resulted from alerts were also estimated. Drug orders were conservatively assigned a duration of 30 days of use for a chronic drug and 10 days for antibiotics. It was determined that there were modest reductions in drug costs, partially offset by an increase in laboratory-related costs. Overall, there was a reduction in direct costs (US

Off-Label Prescribing in Older People

1391.43, net 7.6% reduction). However, sensitivity analyses based on alternative estimates of duration of drug use suggested a reduction as high as US

Application of Recursive Partitioning to Derive and Validate a Claims-Based Algorithm for Identifying Keratinocyte Carcinoma (Nonmelanoma Skin Cancer).

7998.33 if orders for non-antibiotic drugs were assumed to be continued for 180 days. The authors conclude that the immediate and direct financial impact of a clinical decision support system for medication ordering for residents with renal insufficiency is modest and that the primary motivation for such efforts must be to improve the quality and safety of medication ordering.

Prospective evaluation of the accessibility of Internet references in leading general medical journals

Off-label prescribing is the prescribing of a drug therapy in a manner that was not approved by the regulatory agency. This not only includes prescribing a drug for a disease for which it has not been specifically licensed, but also encompasses using a dose outside of the recommended range or in unapproved subpopulations. As outlined by Jackson et al., off-label prescribing is common and in some circumstances may be necessary and beneficial. In general, this approach should be taken only after careful consideration of the risks and benefits. Off-label prescribing inherently involves extrapolating evidence on both safety and effectiveness to a new indication or to an unstudied population. Postmarketing surveillance studies have demonstrated that drugs prescribed off-label can be associated with serious adverse events, particularly when they are used for an unapproved indication. Our work has demonstrated that there can be serious consequences when antipsychotic therapy is used in vulnerable elderly patients with dementia. Furthermore, our research has shown that once off-label prescribing becomes common practice, studies showing harm, as well as regulatory warnings, have little effect on prescribing. We believe that cautious prescribing and increased awareness about off-label drug use, particularly in the elderly, are important. Jackson et al. suggest strategies to assist practitioners when considering off-label prescribing, the first being, ‘‘Know the licensed indications of a drug’’. While we agree with this statement, offlabel prescribing of certain drugs is so common that several off-label uses are accepted as standard care simply because they are so commonly prescribed. Physicians may not fully appreciate the fact that the original studies, which may have been published decades earlier, were not carried out in the disease they are treating and in fact the drug is not licensed for the indication they are using it for. This is especially true for drugs commonly prescribed off-label, such as central nervous system medications (i.e. anticonvulsants, antipsychotics and antidepressants) or cardiovascular drugs. Chen et al. found that just over 50% of physicians correctly identified the US FDAapproval status of commonly prescribed drugs. Furthermore, some physicians surveyed erroneously believed that drugs were FDA approved for specific conditions despite prior black-box warnings stating increased adverse events including death in the population being treated. Although one might argue that it is the level of evidence that should guide therapy, awareness of the approved indication for a drug is important as this shows that the drug has successfully gone through rigorous testing for its use in specified conditions. Furthermore, knowing that a drug is not approved for a condition should alert the prescriber to the possibility of increased adverse events and perhaps the need for closer monitoring of the patient receiving the medication as well as the possible lack of scientific literature to support its use. An incorrect assumption that a drug is approved by a licensing agency reflects an inaccurate understanding COMMENTARY Drugs Aging 2012; 29 (6): 435-436 1170-229X/12/0006-0435/