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Objective: Growing evidence indicates that life-sustaining therapies for the treatment of acute myocardial infarction (AMI) are underused among patients eligible for therapy, including the elderly and women. We examined the effect of a patient's comorbidity burden on use of these highly effective therapies in eligible populations of individuals with AMI.Design: Retrospective cohort design.Setting and Patients: We reviewed the medical records of 2,409 individuals at 37 Minnesota hospitals from October 1992 through July 1993 with an admission diagnosis of AMI, suspected AMI, or rule-out AMI, who met electrocardiographic, laboratory, and clinical criteria for AMI.Measurements and Main Results: Using multivariate logistic regression models, we determined the association between a validated comorbidity measure and the proportion of eligible patients who received thrombolysis or aspirin. Controlling for other factors previously reported to influence rates of study treatment, the odds of receipt of thrombolysis among patients with severe comorbidity was 0.49 (95% confidence interval [CI] 0.27, 0.88) when compared with individuals without such limitation. Similarly, the odds of aspirin treatment among study patients with severe comorbidity was 0.46 (95% CI 0.30 0.72), compared with individuals without severe comorbidity. We did not distinguish any differences in patterns of treatment with either study treatment among patients with mild or moderate comorbidity when compared with individuals without any concomitant comorbidity.Conclusions: This study indicates that patients with severe mental and physical comorbidities are less likely to receive standard therapies for AMI recommended in national treatment guidelines. [ABSTRACT FROM AUTHOR]

This study analyzed whether or not there is any correlation between the level of electronic readiness (e-readiness) and corruption in countries. The study was guided by the theory of network society, the Unified Theory of Acceptance and Use of Technology (UTAUT) as well as Technology Acceptance Model (TAM). The study opted for secondary data from 147 countries of the world for both measures of e-readiness (Global Information Technology) and corruption perception index (from Transparency International) for 2014. Statistical analysis was done using correlation and regression analyses. Four sub measures for e-readiness included networked readiness index, environment readiness index, society readiness index, and usage readiness index (independent variables). Results from the study showed there is correlation between the two variables. Based on the objective of this study, it is concluded that the higher the e-readiness, the low the corruption. This implies that one way of combating corruption is to attain good e-readiness index.

Abstract Background Although an increasing number of studies are documenting uses of syndromic surveillance by front line public health, few detail the value added from linking syndromic data to public health decision-making. This study seeks to understand how syndromic data informed specific public health actions during the 2009 H1N1 pandemic. Methods Semi-structured telephone interviews were conducted with participants from Ontario’s public health departments, the provincial ministry of health and federal public health agency to gather information about syndromic surveillance systems used and the role of syndromic data in informing specific public health actions taken during the pandemic. Responses were compared with how the same decisions were made by non-syndromic surveillance users. Results Findings from 56 interviews (82% response) show that syndromic data were most used for monitoring virus activity, measuring impact on the health care system and informing the opening of influenza assessment centres in several jurisdictions, and supporting communications and messaging, rather than its intended purpose of early outbreak detection. Syndromic data had limited impact on decisions that involved the operation of immunization clinics, school closures, sending information letters home with school children or providing recommendations to health care providers. Both syndromic surveillance users and non-users reported that guidance from the provincial ministry of health, communications with stakeholders and vaccine availability were driving factors in these public health decisions. Conclusions Syndromic surveillance had limited use in decision-making during the 2009 H1N1 pandemic in Ontario. This study provides insights into the reasons why this occurred. Despite this, syndromic data were valued for providing situational awareness and confidence to support public communications and recommendations. Developing an understanding of how syndromic data are utilized during public health events provides valuable evidence to support future investments in public health surveillance.

Abstract Background Immunization information systems (IISs) are electronic registries used to monitor individual vaccination status and assess vaccine coverage. IISs are currently not widely used across Canada, where health jurisdictions employ a range of approaches to capture influenza immunization information. Conducted in advance of the 2009 H1N1 vaccination campaign, the objectives of this study were to understand the perceived value of individual-level data and IISs for influenza control, identify ideal system functions, and explore barriers to implementation. Methods In July and August 2009, semi-structured interviews were conducted with key informants engaged in vaccine delivery and/or pandemic planning at regional, provincial/territorial and federal levels across Canada. Key informants were recruited using a combination of convenience and snowball sampling methodologies. Qualitative analysis was used to extract themes from interview content. Results Patient management, assessment of vaccine coverage, and evaluation of safety and effectiveness were identified as public health priorities that would be achieved in a more timely manner, and with greater accuracy, through the use of an IIS. Features described as ideal included system flexibility, rapid data entry, and universality. Financial and human resource constraints as well as coordination between immunization providers were expressed as barriers to implementation. Conclusions IISs were perceived as valuable by key informants for strengthening management capacity and improving evaluation of both seasonal and pandemic influenza vaccination campaigns. However, certain implementation restrictions may need to be overcome for these benefits to be achieved.

Abstract Background Stigma refers to a distinguishing personal trait that is perceived as or actually is physically, socially, or psychologically disadvantageous. Little is known about the opinion of those who have more or less stigmatizing health conditions regarding the need for consent for use of their personal information for health research. Methods We surveyed the opinions of people 18 years and older with seven health conditions. Participants were drawn from: physicians' offices and clinics in southern Ontario; and from a cross-Canada marketing panel of individuals with the target health conditions. For each of five research scenarios presented, respondents chose one of five consent choices: (1) no need for me to know; (2) notice with opt-out; (3) broad opt-in; (4) project-specific permission; and (5) this information should not be used. Consent choices were regressed onto: demographics; health condition; and attitude measures of privacy, disclosure concern, and the benefits of health research. We conducted focus groups to discuss possible reasons for observed consent choices. Results We observed substantial variation in the control that people wish to have over use of their personal information for research. However, consent choice profiles were similar across health conditions, possibly due to sampling bias. Research involving profit or requiring linkage of health information with income, education, or occupation were associated with more restrictive consent choices. People were more willing to link their health information with biological samples than with information about their income, occupation, or education. Conclusions The heterogeneity in consent choices suggests individuals should be offered some choice in use of their information for different types of health research, even if limited to selectively opting-out. Some of the implementation challenges could be designed into the interoperable electronic health record. However, many questions remain, including how best to capture the opinions of those who are more privacy sensitive.

Abstract Background The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues. Methods We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly. Results Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research. Conclusion Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research.

Abstract Background The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks. Methods Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank. Results There was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied. Conclusion Participants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation.

Abstract Background In earlier work, we found important selection biases when we tried to obtain consent for participation in a national stroke registry. Recognizing that not all registries will be exempt from requiring consent for participation, we examine here in greater depth the reasons for the poor accrual of patients from a systems perspective with a view to obtaining as representative sample as possible. Methods We determined the percent of eligible patients who were approached to participate and, among those approached, the percent who actually consented to participate. In addition we examined the reasons why people were not approached or did not consent and the variation across sites in the percent of patients approached and consented. We also considered site variation in restrictions on the accrual and data collection process imposed by either the local research ethics board or the hospital. Results Seventy percent of stroke patients were approached, with wide variations in approach rates across sites (from: 41% to 86%), and considerable inter-site variation in hospital policies governing patient accrual. Chief reasons for not approaching were discharge or death before being approached for consent. Seventeen percent of those approached refused to participate (range: 5% to 75%). Finally, 11% of those approached did not participate due to language or communication difficulties. Conclusion We found wide variation in approach and agree rates across sites that were accounted for, in part, by different approaches to accrual and idiosyncratic policies of the hospitals. This wide variation in approach and agree rates raises important challenges for research ethics boards and data protection authorities in determining when to waive consent requirements, when to press for increased quality control, when to permit local adaptation of the consent process, and when to permit alternatives to individual express consent. We offer several suggestions for those registries that require consent for participation.

Background: Rapid ethical access to personal health information (PHI) to support research is extremely important during pandemics, yet little is known regarding patient preferences for consent during such crises. This follow-up study sought to ascertain whether there were differences in consent preferences between pre-pandemic times compared to during Wave 1 of the COVID-19 global pandemic, and to better understand the reasons behind these preferences., Methods: A total of 183 patients in the pandemic cohort completed the survey via email, and responses were compared to the distinct pre-pandemic cohort (n = 222); all were patients of a large Canadian cancer center. The survey covered (a) broad versus study-specific consent; (b) opt-in versus opt-out contact approach; (c) levels of comfort sharing with different recipients; (d) perceptions of commercialization; and (e) options to track use of information and be notified of results. Four focus groups (n = 12) were subsequently conducted to elucidate reasons motivating dominant preferences., Results: Patients in the pandemic cohort were significantly more comfortable with sharing all information and biological samples (90% vs. 79%, p = 0.009), sharing information with the health care institution (97% vs. 83%, p < 0.001), sharing information with researchers at other hospitals (85% vs. 70%, p < 0.001), sharing PHI provincially (69% vs. 53%, p < 0.002), nationally (65% vs. 53%, p = 0.022) and internationally (48% vs. 39%, p = 0.024) compared to the pre-pandemic cohort. Discomfort with sharing information with commercial companies remained unchanged between the two cohorts (50% vs. 51% uncomfortable, p = 0.58). Significantly more pandemic cohort patients expressed a wish to track use of PHI (75% vs. 61%, p = 0.007), and to be notified of results (83% vs. 70%, p = 0.012). Thematic analysis uncovered that transparency was strongly desired on outside PHI use, particularly when commercialization was involved., Conclusions: In pandemic times, patients were more comfortable sharing information with all parties, except with commercial entities, where levels of discomfort (~ 50%) remained unchanged. Focus groups identified that the ability to track and receive results of studies using one's PHI is an important way to reduce discomfort and increase trust. These findings meaningfully inform wider discussions on the use of personal health information for research during global crises., (© 2022. The Author(s).)

Background: Immense volumes of personal health information (PHI) are required to realize the anticipated benefits of artificial intelligence in clinical medicine. To maintain public trust in medical research, consent policies must evolve to reflect contemporary patient preferences., Methods: Patients were invited to complete a 27-item survey focusing on: (a) broad versus specific consent; (b) opt-in versus opt-out approaches; (c) comfort level sharing with different recipients; (d) attitudes towards commercialization; and (e) options to track PHI use and study results., Results: 222 participants were included in the analysis; 83% were comfortable sharing PHI with researchers at their own hospital, although younger patients (≤ 49 years) were more uncomfortable than older patients (50 + years; 13% versus 2% uncomfortable, p < 0.05). While 56% of patients preferred broad consent, 38% preferred specific consent; 6% preferred not sharing at all. The majority of patients (63%) preferred to be asked for permission before entry into a contact pool. Again, this trend was more pronounced for younger patients (≤ 49 years: 76%). Approximately half of patients were uncomfortable sharing PHI with commercial enterprises (51% uncomfortable, 27% comfortable, 22% neutral). Most patients preferred to track PHI usage (61%), with the highest proportion once again reported by the youngest patients (≤ 49 years: 71%). A majority of patients also wished to be notified regarding study results (70%)., Conclusions: While most patients were willing to share their PHI with researchers within their own institution, many preferred a transparent and reciprocal consent process. These data also suggest a generational shift, wherein younger patients preferred more specific consent options. Modernizing consent policies to reflect increased autonomy is crucial in fostering sustained public engagement with medical research.

Background: Many health professional and regulatory groups have guidelines for identifying, disclosing and managing potential conflicts of interest (COI). The opinions of the Canadian public regarding what constitutes COI are unknown., Methods: Bilingual telephone survey in all provinces using a validated questionnaire on public opinions on physician-pharmaceutical industry interactions (POPPII). Adults 18 years or older were contacted using random digit dialing (RDD) with representative national sampling of households. Results were analyzed for predictors of opinions and were compared with the reference COI guideline. Two follow-up focus groups were held., Results: 1041 participants (56.8% female, mean age 52.6 years (SD 16.5), 18.2% francophone, 57.7% with post-secondary education) completed the survey. 34.0% reported a prior concern about physician-pharmaceutical industry relationships. Acceptability of interactions varied from high for requesting information about a particular drug or small gifts of obvious educational value to the patient, to mixed for free meals to listen to pharmaceutical industry personnel or payment to attend a conference, to low for research recruitment fees, personal use of medication samples or for using information not yet public about a new drug to make investment decisions. Age of the participant influenced ratings of acceptability. There was reasonable agreement (>60% participants) with only half of the related reference COI guideline statements., Conclusions: Public opinions on physician-pharmaceutical industry interactions differ depending on the scenario but suggest a significant level of concern regarding interactions involving direct financial benefit to physicians., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Objectives: Building on previous research noting variations in the operation and perceived utility of syndromic surveillance systems in Ontario, the timeliness of these different syndromic systems for detecting the onset of both 2009 H1N1 pandemic (A(H1N1)pdm09) waves relative to laboratory testing data was assessed using a standardized analytic algorithm., Methods: Syndromic data, specifically local emergency department (ED) visit and school absenteeism data, as well as provincial Telehealth (telephone helpline) and antiviral prescription data, were analyzed retrospectively for the period April 1, 2009 to January 31, 2010. The C2-MEDIUM aberration detection method from the US Centers for Disease Control and Prevention's EARS software was used to detect increases above expected in syndromic data, and compared to laboratory alerts, defined as notice of confirmed A(H1N1)pdm09 cases over two consecutive days, to assess relative timeliness., Results: In Wave 1, provincial-level alerts were detected for antiviral prescriptions and Telehealth respiratory calls before the laboratory alert. In Wave 2, Telehealth respiratory calls similarly alerted in advance of the laboratory, while local alerts from ED visit, antiviral prescription and school absenteeism data varied in timing relative to the laboratory alerts. Alerts from syndromic data were also observed to coincide with external factors such as media releases., Conclusions: Alerts from syndromic surveillance systems may be influenced by external factors and variation in system operations. Further understanding of both the impact of external factors on surveillance data and standardizing protocols for defining alerts is needed before the use of syndromic surveillance systems can be optimized.

When responding to a novel infectious disease outbreak, policies are set under time constraints and uncertainty which can limit the ability to control the outbreak and result in unintended consequences including lack of public confidence. The H1N1 pandemic highlighted challenges in public health decision-making during a public health emergency. Understanding this process to identify barriers and modifiable influences is important to improve the response to future emergencies. The purpose of this study is to examine the H1N1 pandemic decision-making process in Canada with an emphasis on the use of evidence for public health decisions. Using semi-structured key informant interviews conducted after the pandemic (July-November 2010) and a document analysis, we examined four highly debated pandemic policies: use of adjuvanted vaccine by pregnant women, vaccine priority groups and sequencing, school closures and personal protective equipment. Data were analysed for thematic content guided by Lomas' policy decision-making framework as well as indicative coding using iterative methods. We interviewed 40 public health officials and scientific advisors across Canada and reviewed 76 pandemic policy documents. Our analysis revealed that pandemic pre-planning resulted in strong beliefs, which defined the decision-making process. Existing ideological perspectives of evidence strongly influenced how information was used such that the same evidentiary sources were interpreted differently according to the ideological perspective. Participants recognized that current models for public health decision-making failed to make explicit the roles of scientific evidence in relation to contextual factors. Conflict avoidance theory explained policy decisions that went against the prevailing evidence. Clarification of roles and responsibilities within the public health system would reduce duplication and maintain credibility. A more transparent and iterative approach to incorporating evidence into public health decision-making that reflects the realities of the external pressures present during a public health emergency is needed., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Background: Despite the growing popularity of syndromic surveillance, little is known about if or how these systems are accepted, utilized and valued by end users. This study seeks to describe the use of syndromic surveillance systems in Ontario and users' perceptions of the value of these systems within the context of other surveillance systems., Methods: Ontario's 36 public health units, the provincial ministry of health and federal public health agency completed a web survey to identify traditional and syndromic surveillance systems used routinely and during the pandemic and to describe system attributes and utility in monitoring pandemic activity and informing decision-making., Results: Syndromic surveillance systems are used by 20/38 (53%) organizations. For routine surveillance, laboratory, integrated Public Health Information System and school absenteeism data are the most frequently used sources. Laboratory data received the highest ratings for reliability, timeliness and accuracy ('very acceptable' by 92, 51 and 89%). Hospital/clinic screening data were rated as the most reliable and timely syndromic data source (50 and 43%) and ED visit data the most accurate (48%). During the pandemic, laboratory data were considered the most useful for monitoring the epidemiology and informing decision-making while ED screening and visit data were considered the most useful syndromic sources., Conclusions: End user perceptions are valuable for identifying opportunities for improvement and guiding further investments in public health surveillance.

Background: We designed a seroprevalence study using multiple testing assays and population sources to estimate the community seroprevalence of pH1N1/09 and risk factors for infection before the outbreak was recognized and throughout the pandemic to the end of 2009/10 influenza season., Methods: Residual serum specimens from five time points (between 01/2009 and 05/2010) and samples from two time points from a prospectively recruited cohort were included. The distribution of risk factors was explored in multivariate adjusted analyses using logistic regression among the cohort. Antibody levels were measured by hemagglutination inhibition (HAI) and microneutralization (MN) assays., Results: Residual sera from 3375 patients and 1024 prospectively recruited cohort participants were analyzed. Pre-pandemic seroprevalence ranged from 2%-12% across age groups. Overall seropositivity ranged from 10%-19% post-first wave and 32%-41% by the end of the 2009/10 influenza season. Seroprevalence and risk factors differed between MN and HAI assays, particularly in older age groups and between waves. Following the H1N1 vaccination program, higher GMT were noted among vaccinated individuals. Overall, 20-30% of the population was estimated to be infected., Conclusions: Combining population sources of sera across five time points with prospectively collected epidemiological information yielded a complete description of the evolution of pH1N1 infection.

Background: Methods are needed for using confidential data to select and reach patients without compromising their health privacy., Methods: (a), Sampling: we created (1) an anonymous list of encrypted personal health numbers (EPHNs) of target patients (e.g., users of the medications of interest) and (2) an anonymous list of EPHNs of people randomly sampled from the general population of non-users. The two lists were merged and randomly ordered to make a camouflaged list. People on the second list were called camouflagers. Then EPHNs were matched to names and contact information, and the EPHNs were removed from the contact list. (b) Contacting: when we contacted patients by mail or telephone, we told them their names were selected from one of two lists, and their health status was unknown to us. We invited respondents to answer (1) a short survey for the general population or (2) a longer survey concerning the target condition., Results: In five studies, the percentage of camouflagers--equal to one minus the positive predictive value of the camouflaged list--has varied from 10 to over 50%. This depended on the psychosocial sensitivity of the target medications or health conditions, the natural camouflaging by the population's heterogeneity or inaccuracy of the data on the target characteristic, the degree of stratification of the sample, and the cost of contacting., Conclusion: Camouflaging enables administrative data to be used for contacting target patients in selected populations while adhering to current data privacy laws and ethics principles.

Toward identifying the roles of protease-activated receptor-1 (PAR1) and other G protein-coupled receptors important for vascular development, we investigated the role of Galpha13 in endothelial cells in the mouse embryo. LacZ inserted into Galpha13 exon 1 was highly expressed in endothelial cells at midgestation. Endothelial-specific Galpha13 knockout embryos died at embryonic days 9.5-11.5 and resembled the PAR1 knockout. Restoration of Galpha13 expression in endothelial cells by use of a Tie2 promoter-driven Galpha13 transgene rescued development of endothelial-specific Galpha13 knockout embryos as well the embryonic day 9.5 vascular phenotype in Galpha13 conventional knockouts; transgene-positive Galpha13-/- embryos developed for several days beyond their transgene-negative Galpha13-/- littermates and then manifested a previously uncharacterized phenotype that included intracranial bleeding and exencephaly. Taken together, our results suggest a critical role for Galpha13 in endothelial cells during vascular development, place Galpha13 as a candidate mediator of PAR1 signaling in this process, and reveal roles for Galpha13 in other cell types in the mammalian embryo.

Objective: To explore the consent preferences of patients whose health data are currently being used for research purposes., Methods: Semi-structured interviews were conducted with 17 patients whose primary physicians were taking part in a study that utilized de-identified individual-level health information from their electronic medical record. All physicians practised in southwestern Ontario. All interviews were taped, transcribed verbatim and analysed using a constant comparative method. All transcripts and debriefing notes were read and reread to elicit general themes., Results: Three main themes emerged from the data: patients recognized the need to balance their consent preferences with time pressures in the clinical encounter when deciding the nature of consent for a study; patients generally regarded the seeking of consent as being an issue of respect for them as individuals; and patients were also weighing their perceived benefits and concerns related to the research. For these patients, seeking their consent was an important step in research participation. For some patients, the sponsor and the research topic were factors that would influence their decision to provide consent., Conclusion: Patients want their consent to be sought when their data are used for research purposes. This will involve explicitly informing patients that a study is taking place, providing written consent and offering regular updates about the study.

This paper has three parts. The first part describes developments in the use of personal information for health research in Canada, challenges in responding to new data protection legislation and the work of the Canadian Institutes of Health Research in assisting the research community to adapt to these developments. The second part critiques two aspects of the stakeholder analysis posited in William Lowrance's report: the lack of an analysis of researchers' interests as distinct from those of society at large, and the framing of privacy as an individual interest. I argue for recasting the privacy and research tension as a values conflict between two societal goods and not an individual versus a societal interest, and for explicitly acknowledging researchers' interests as data users. In so doing, there is no clear trump of privacy or research, and greater importance is placed upon the weighing of benefits and risks of individual studies to determine whether the waiving of consent for a particular study or programme of research is justified. The third part makes specific suggestions as to future ways in which data use practices may evolve. I argue the need to engage the public in deliberating the broad parameters under which personal information will be used, as the public collectively has a major stake in this issue and their input provides legitimacy for these uses of information. In addition, given the proliferation of prospectively-developed databases for research purposes, a 'systems' approach for obtaining consent for participation to replace the current study-by-study recruitment of individuals is appropriate.

Background: Every year in Ontario, the records of over 42 million prescriptions dispensed to persons eligible for Ontario Drug Benefit (ODB) benefits are transmitted to a central database. The ODB database is the second largest database of medications in Canada, containing records on almost half of all medications dispensed in Ontario. There is no information about the reliability of the coding on the ODB drug claims database and, therefore, the objective of this study was to estimate the reliability of coding of the Drug Identification Number, and the date, quantity and duration of the dispensation on claims sent to the ODB., Methods: To meet this objective, approximately 100 randomly selected prescriptions dispensed from each of 50 pharmacies in southern Ontario between July 1, 1998 and December 31, 1999 were audited. For each claim, the written information on the prescription was compared with the electronic information submitted to the ODB database. Logistic regression was used to test the association between coding errors and the location, owner affiliation, and productivity of each pharmacy (defined as the annual volume of dispensations divided by the annual number of hours worked by all pharmacists and pharmacy assistants)., Results: Of the 183 pharmacies owners invited to participate, consent to abstract information was obtained in 50, yielding a participation rate of 27%. Of the 5155 dispensed prescriptions, 37 errors were found, yielding an overall error rate of 0.7% (95% CI 0.5% to 0.9%). None of the characteristics of pharmacies that were examined (location, owner affiliation, productivity) was associated with coding errors., Conclusions: Pharmacists almost always dispense the medication that is prescribed and this information is reliably transmitted to the ODB drug claims database. This means that any conclusions drawn by researchers using these data are not likely to be compromised by low coding reliability.

Objective: To determine demographic and clinical factors associated with delayed thrombolysis in patients with acute myocardial infarction., Design: A retrospective cohort., Setting: 37 Minnesota hospitals during the time periods October 1992-July 1993 and July 1995-April 1996., Patients: We reviewed the medical records of 776 older patients aged 65 or older hospitalized with an admission diagnosis of acute myocardial infarction, suspected acute myocardial infarction, or rule-out acute myocardial infarction, who were treated with a thrombolytic agent., Measurement: We used multivariate logistic regression models to examine the association between selected study characteristics and time between hospital presentation and administration of thrombolytic treatment. Early thrombolysis was defined as less than 60 minutes after hospital presentation and late thrombolysis as 60+ minutes., Results: Of 776 study patients, 57.5% (n = 446) received early thrombolysis. Of the remaining 330 patients receiving late treatment, 12.1% (n = 94) were thrombolyzed more than 2 hours after hospital presentation. After controlling for other factors, the odds of delayed thrombolysis among patients aged 75 or older were 1.48 compared with younger individuals (95% CI, 1.17-1.88). The odds of delayed thrombolysis among patients with severe comorbidity were 1.46 (95% CI, 1.10-1.94) compared with individuals without severe comorbidity. Predictors of early thrombolytic treatment included hospital arrival via emergency transport (ORdelay = 0.46; 95% CI, 0.34-0.63) and chest discomfort at admission (ORdelay = 0.40; 95% CI, 0.18-0.86)., Conclusions: The present study indicates that patients of advanced age and with severe comorbidity are more likely to experience delayed thrombolytic treatment after hospital presentation. These are the patients who suffer the highest morbidity from acute myocardial infarction and for whom expeditious treatment may enhance therapeutic benefit.

The use of research evidence in policy making at the legislative and administrative levels would appear to be very selective. Focusing on pharmaceutical policy, this paper argues that research evidence is only one ingredient leading to a policy decision and that any examination of research transfer into policy must take into account the many other factors which impact on decision making. The paper describes the policy making process, barriers to the uptake of research evidence into policy and ways of improving research uptake into policy making. Examples are given from drug licensing, remuneration policies, post-marketing surveillance and product withdrawal from the market.

Objective: The aim of this study was to evaluate the cost effectiveness of multi-therapy treatment strategies in the prevention of vertebral fractures in postmenopausal women with osteoporosis., Design: A retrospective, incremental cost-effectiveness analysis was conducted from a societal perspective. It compared 9 treatment strategies over 3 years and incorporated the willingness of patients to initiate and continue each therapy., Main Outcome Measures and Results: Four nondominated strategies formed the efficient frontier in the following order: (i) calcium-->no therapy; (ii) ovarian hormone therapy (OHT)-->calcium-->no therapy [166 Canadian dollars ($Can)]; (iii) OHT-->etidronate-->calcium-->no therapy ($Can2331); and (iv) OHT-->alendronate-->calcium-->no therapy ($Can40,965). The figures in parentheses are the incremental costs per vertebral fracture averted to move to that strategy from the previous strategy for patients who had undergone a hysterectomy., Conclusions: We identified 4 efficient multi-therapy strategies for the treatment of vertebral osteoporosis in postmenopausal women, 2 of which were consistent with the practice guidelines of the Osteoporosis Society of Canada. Decision-makers may select from among these efficient strategies on the basis of incremental cost effectiveness.

Background: The rapid expansion of managed care in the United States has increased debate regarding the appropriate mix of generalist and specialist involvement in medical care., Objective: To compare the quality of medical care when generalists and cardiologists work separately or together in the management of patients with acute myocardial infarction (AMI)., Methods: We reviewed the charts of 1716 patients with AMI treated at 22 Minnesota hospitals between 1992 and 1993. Patients eligible for thrombolytic aspirin, beta-blockers, and lidocaine therapy were identified using criteria from the 1991 American College of Cardiology guidelines for the management of AMI. We compared the use of these drugs among eligible patients whose attending physician was a generalist with no cardiologist input, a generalist with a cardiologist consultation, and a cardiologist alone., Results: Patients cared for by a cardiologist alone were younger, presented earlier to the hospital, were more likely to be male, had less severe comorbidity, and were more likely to have an ST elevation of 1 mm or more than generalists' patients. Controlling for these differences, there was no variation in the use of effective agents between patients cared for by a cardiologist attending physician and a generalist with a consultation by a cardiologist. However, there was a consistent trend toward increased use of aspirin, thrombolytics, and beta-blockers in these patients compared with those with a generalist attending physician only (P<.05 for beta-blockers only). Differences between groups in the use of lidocaine were not statistically significant. The adjusted probabilities of use of thrombolytics for consultative care and cardiologist attending physicians were 0.73 for both. Corresponding probabilities were 0.86 and 0.85 for aspirin and 0.59 and 0.57 for beta-blockers, respectively., Conclusions: For patients with AMI, consultation between generalists and specialists may improve the quality of care. Recent policy debates that have focused solely on access to specialists have ignored the important issue of coordination of care between generalist and specialist physicians. In hospitals where cardiology services are available, generalists may be caring for patients with AMI who are older and more frail. Future research and policy analyses should examine whether this pattern of selective referral is true for other medical conditions.

Context: The effectiveness of recruiting local medical opinion leaders to improve quality of care is poorly understood., Objective: To evaluate a guideline-implementation intervention of clinician education by local opinion leaders and performance feedback to (1) increase use of lifesaving drugs (aspirin and thrombolytics in eligible elderly patients, beta-blockers in all eligible patients) for acute myocardial infarction (AMI), and (2) decrease use of a potentially harmful therapy (prophylactic lidocaine)., Design: Randomized controlled trial with hospital as the unit of randomization, intervention, and analysis., Setting: Thirty-seven community hospitals in Minnesota., Patients: All patients with AMI admitted to study hospitals over 10 months before (1992-1993, N=2409) or after (1995-1996, N=2938) the intervention., Intervention: Using a validated survey, we identified opinion leaders at 20 experimental hospitals who influenced peers through small and large group discussions, informal consultations, and revisions of protocols and clinical pathways. They focused on (1) evidence (drug efficacy), (2) comparative performance, and (3) barriers to change. Control hospitals received mailed performance feedback., Main Outcome Measures: Hospital-specific changes before and after the intervention in the proportion of eligible patients receiving each study drug., Results: Among experimental hospitals, the median change in the proportion of eligible elderly patients receiving aspirin was +0.13 (17% increase from 0.77 at baseline), compared with a change of -0.03 at control hospitals (P=.04). For beta-blockers, the respective changes were +0.31 (63% increase from 0.49 at baseline) vs +0.18 (30% increase from baseline) for controls (P=.02). Lidocaine use declined by about 50% in both groups. The intervention did not increase thrombolysis in the elderly (from 0.73 at baseline), but nearly two thirds of eligible nonrecipients were older than 85 years, had severe comorbidities, or presented after at least 6 hours., Conclusions: Working with opinion leaders and providing performance feedback can accelerate adoption of some beneficial AMI therapies (eg, aspirin, beta-blockers). Secular changes in knowledge and hospital protocols may extinguish outdated practices (eg, prophylactic lidocaine). However, it is more difficult to increase use of effective but riskier treatments (eg, thrombolysis) for frail elderly patients.

Background: In patients who have had acute myocardial infarction, the delay between the onset of symptoms and hospital presentation is a critical factor in determining the initial management strategy and outcomes of treatment., Objective: To examine the determinants of delayed hospital presentation in patients who have had acute myocardial infarction., Design: Retrospective chart review., Setting: 37 hospitals in Minnesota., Patients: 2409 persons hospitalized with acute myocardial infarction between October 1992 and July 1993., Main Outcome Measure: Hospital presentation delayed more than 6 hours after the onset of symptoms of acute myocardial infarction., Results: Information on length of delay was available for 2404 patients. Of these patients, 969 (40%) delayed presentation to the hospital for more than 6 hours after the onset of symptoms. Factors associated with prolonged delay included advanced age and female sex. The presence of chest discomfort and a history of mechanical revascularization significantly reduced the risk for prolonged delay. Risk for delay was greatest during the evening and early morning hours (6:00 p.m. to 6:00 a.m.) Patients with a history of hypertension were more likely to delay presentation. Only 42% of all patients hospitalized with acute myocardial infarction had used emergency medical transport services., Conclusions: Patients who have had acute myocardial infarction often delay hospital presentation. Educational interventions that encourage the prompt use of emergency medical transport services and target specific patient populations, such as elderly persons, women, and persons with cardiac risk factors, may be most successful in reducing the length of delay and improving the outcomes of patients with acute myocardial infarction.