In 1975, Peter Herberts initiated a national study of all reoperations after total hip replacement (THR) in Sweden. This study was designed as a trial lasting for almost 2 years (1976–1977). The goal was to learn more about severe complications of THR and thereby improve on the results. It was considered impossible to collect all primary hip replacements because of the vast number of operations.The pilot study was designed as a retrospective one to evaluate whether a number of key parameters associated with reoperation of total hip arthroplasties could be collected for statistical analysis at a national level. Importantly, it was decided that any further operation after the primary procedure, regardless of whether the implants were exchanged (revision) or not, should be used as failure parameter. Later on, it turned out that the choice of data collected was well suited to analysis of outcome, which contributed to the future success of the Register, not least by stimulation of continuous learning and improvement.Almost all orthopedics departments performing hip replacements participated in this project, which eventually comprised 513 reoperations. One important experience was that complications were far more common after reoperations than after primary surgery. About a third of all reoperations were associated with further complications .Encouraged by the success of this pilot study, the orthopedics profession in Sweden was again asked if the members would participate in a prospective and continuous national multicenter study of reoperations after THR. At the initiation of this National Register in January 1979, all (at that time 62) but 1 department, which joined somewhat later, accepted to participate. Peter Herberts, who initiated the pilot study, became the leader of the Register and continued in this capacity for 30 years.For the first 7 years, the Register was funded as a research project within an academic program. A research fellow, Lennart Ahnfelt, originally recruited for the pilot project, presented his thesis on this subject in 1986, which summarized the results up to 1983 . The proFrom the beginning, all individual reoperations were identified using the patient’s social security number. Medical records on every reoperation were collected. More than 100 parameters including demographic data, details of surgical technique, the implant used, the operating unit, and the type and history of the previously used implant or implants were recorded by specially trained secretaries. To enable calculation of implant survival, each hospital delivered information about implants used from 1967 onwards. From 1979 and until 1991, the hospitals continued to deliver details about primary hip arthroplasties on an aggregated level and for each year. This meant that it was not possible to track each individual primary operation to a social security number, which resulted in the need for approximations in order to calculate implant survival. This could, however, be done by the use of information from other governmental registers and statistically-based models  but 1 participating unit. The importance of being in charge of your own IT development resulted in well-designed applications that were rapidly implemented.In 2002, Göran Garellick introduced patient-reported outcome measurements (PROMs) to the register . PatientAt the turn of the century, there was increasing external demand—not least from journalists—to gain access to the results of THR at the departmental level. In a law suit, it was decided that no such data should be generally available. Even so, in 1999—in order to meet this demand and to play down the impact of this information—the Register holders decided to present some of the results openly, in cooperation with the orthopedic profession. Later on, several outcome parameters were added. This open access to key variables (to account for outcome) became the state of the art for Registers in Sweden. This is now supported by the Swedish National Board of Health and Welfare and the Swedish Association of Local Authorities and Regions (SALAR).Today, the annual register report includes not only implant survival and the PROM variables. Reoperations within 2 years are used as a fast indicator of surgical quality. In addition, re-admission within 30 days and mortality within 90 days are reported for every operating unit. A simple case-mix factor based on sex, diagnosis, and age at surgery is used to indicate the average risk factor for the population operated at the individual hospitals. This is essential for comparisons between units, since the hospitals operate upon vastly different types of patients and have different commissions.In 2005, a further step forward was taken when all hemiarthroplasties were recorded. Use of the same organization as that already being employed for total hips resulted in an immediate nationwide coverage. Even though these two registers are closely connected, the hemiarthroplasty register is a separate entity from the total hip arthroplasty register, with Cecilia Rogmark as project leader.The annual report contains a general part covering demographic data, frequencies of procedures, choice of implant and fixation, and survival of the different implants or surgical techniques on a national basis. The same data are also reported regionally and to the individual units, but no single-surgeon data are recorded. To achieve full compliance, all surgeons have been assured of confidentiality. Each unit has full access to its own data, however, which allows a learning process at the local level.Each year, one or several in-depth analyses are performed. Such analyses may involve influence of antibiotic prophylaxis, surgical approach, choice of implant design, or other issues. The idea is to provide feedback to the community to facilitate continuous improvement and provide motivation. This way of achieving high-quality hip replacement surgery as reflected by a low revision rate has obviously been successful. Over the years, the revision rate in Sweden has been decreasing continuously.The huge amount of data in this national register is an excellent basis for epidemiological studies of factors that may have a possible influence on the outcome. By synchronization with other national databases, a number of factors related to healthcare accessibility, socioeconomic background, patient demography, associated illness, medication, and many other factors that may influence the outcome, can now be analyzed. Output from the register has often raised further questions and hypotheses, and has prompted further research.The pioneering work surrounding the 2 orthopedics registries, the knee and hip arthroplasty registers, started as less well-known academic activities with only research funding and was sometimes questioned. It has now received both national and international recognition. As a result of the resulting continuous supply of data for national observational studies in Sweden and stimulation of a wide range of research projects, the potential of these registries has become more and more evident. In 2 decades, about 70 similar registries have developed covering much of Swedish healthcare. They all now receive government support and are used to provide guidelines for high-quality, evidence-based medical treatment.


Standardizing the experiences of medical students in a community preceptorship where clinical sites vary by geography and discipline can be challenging. Computer-assisted learning is prevalent in medical education and can help standardize experiences, but often is not used to its fullest advantage. A blended learning curriculum combining web-based modules with face-to-face learning can ensure students obtain core curricular principles.. Students completed surveys rating the content and technical performance of each module and completed a Generalist OSCE exam at the end of the course.This course was developed and used at The Case Western Reserve University School of Medicine and its associated preceptorship sites in the greater Cleveland area. Leaders of a two-year elective continuity experience at the Case Western Reserve School of Medicine used adult learning principles to develop four interactive online modules presenting basics of office practice, difficult patient interviews, common primary care diagnoses, and disease prevention. They can be viewed at Participating students rated all aspects of the course highly; particularly those related to charting and direct patient care. Additionally, they scored very well on the Generalist OSCE exam.Students found the web-based modules to be valuable and to enhance their clinical learning. The blended learning model is a useful tool in designing web-based curriculum for enhancing the clinical curriculum of medical students. Computer assisted instruction in undergraduate medical education has gained popularity in the last two decades. Web-based learning is attractive for many reasons, including the efficiency of providing content at diverse locations, the flexibility that students have in accessing and reviewing content, and the ability to provide online links to related information -3. CompuReports of widespread use of web-based curricula in the medical education literature speak to the convenience and feasibility of this method -12. HoweThe one study that did address the affect of internet-based learning did not specifically target blended learning, but did focus on the affect internet-based instruction had on the learning of health professional students when compared with no intervention and no internet based educational interventions. The authors performed a meta-analysis and concluded that internet-based instruction, when compared with no intervention, was associated with positive learning outcomes, particularly in learner satisfaction and knowledge acquisition, but in the knowledge arena blended learning courses were excluded from the analysis .At the Case Western Reserve University School of Medicine (Case), the Community Primary Care Preceptorship (CPCP) was created as an elective blended learning program consisting of clinical and online components. Interested students completed a two-year primary care preceptorship in the practice of a general internist, family physician, general pediatrician, or medicine-pediatrics physician in the greater Cleveland area. The online instructional component for this course was created with three goals:1. To standardize the core curricular concepts for all students.2. To design online modules based on adult learning principles and present them in a developmentally appropriate manner, with increasing levels of complexity.3. To take advantage of the flexible and interactive nature of the online environment to engage learners and augment and reinforce learning in the clinical setting.The purpose of this paper is to describe the online curriculum as originally developed, as well as present student feedback and performance data.. Learning modules can be found under "For Students." The description of the modules below refers to the content of the CPCP course when it was part of the Case MedicalThe CPCP online curriculum can be viewed at School's Robert Wood Johnson Foundation funded elective Primary Care Track for students interested in exploring careers in primary care (1994–2007). Since then the CPCP curriculum has been amended to be used by the entire student body at Case, and has also been changed to allow educators at other institutions to use its learning activities. For this reason, the interactive parts of the website, described below, are no longer functional, as they required the ability to login to the Case computer system for students to post real-time comments and for course leaders to respond.A panel of community primary care physicians who served as medical student preceptors, identified the topics included in the curriculum thus ensuring the online component would reflect real clinical scenarios. The modules revolve around a panel of "patients" that remains constant, each with a life story that addresses a portion of the curriculum. They include a two-year-old child, an adolescent girl, a young adult woman, a middle-aged adult man, and an elderly woman. Each "patient" has an online chart that is updated after each module and a variety of interactive methodologies make the patients and their clinical issues come to life.Several adult-learning principles guided module development. First, adult learners are self-directed, so modules were constructed so that despite the fixed sequence of the modules themselves, students could complete required components of each module in any order. Also, each module includes links to more detailed information so that students can pursue deeper learning in areas of interest.Further, adult learners are goal and relevancy-oriented, so the information in each module is presented in its most applicable form. Patient scenarios were created to represent common situations, and the practical aspects of responding to those situations are highlighted. Adult learners also bring a wealth of personal experiences to their learning, so the original CPCP modules used open-ended questions and discussion boards to allow students to address clinical issues from their own perspectives. The answers posted to the discussion board were reviewed by the course director and web instructional designer after the students completed each module and relevant feedback and responses were posted for the group to see. As noted above, in order to make this resource available to a larger academic community, the interactive nature of the discussion board has been removed from the current website.Module One is called "You the Primary Care Physician," and is completed in the first half of the second year of medical school, when students have had limited exposure to clinical practice. The opening page shows a "virtual office" with staff members in place and a chart visible on a counter. Students can click on office staff to learn about their roles and responsibilities. They can go to the virtual chart and read a complete new patient note, see a properly completed problem list, and access tutorials on writing Subjective, Objective, Assessment and Plan (SOAP) notes and prescriptions. There is also a short health insurance tutorial followed by a quiz. Students were required to submit a SOAP note from their preceptorship sites for feedback from a course leader and two prescriptions written in the correct format. All of the activities are practical and designed to give students additional background and experience in the nuts and bolts of working in a medical setting.Module Two, "The Art of Medicine," presents topics relating to challenging communication issues including maintaining adolescent confidentiality, addressing hidden agendas, conducting mental status exams in the elderly, confronting patients that miss appointments, and obtaining informed consent. Students enter a virtual waiting room and navigate by clicking on each patient. That patient's scenario is then presented along with audio, video, and text examples of possible responses. When the discussion board was in use, students answered open-ended questions after each scenario reflecting their real experiences in their clinical sites, and responses were posted on a discussion board where other students and faculty members could see them and respond.Module Three is completed in the first half of the third year, when students are comfortable with the basics and can focus on clinical problem solving. It includes the same five patients presenting with common primary care complaints. Each activity includes a discussion of the differential diagnosis, work-up, and treatment of the highlighted condition as well as a related primary care topic such as over-prescription of antibiotics, complementary and alternative medicine, drug interactions, clinical practice guidelines, and use of online resources in real-time patient care. The content, again, is interactive, allowing students to become part of each scenario.The final module, "Disease Prevention," takes students out of the medical office and into the patients' homes. It focuses on accidental injuries in children, metabolic syndrome in the obese, diet and exercise in adults, smoking prevention in teens, the secondary complications of diabetes in older adults, and falls in the elderly. It also employs an interactive format to engage students and originally culminated in each student creating a patient education flyer that was saved and could be accessed by any student when needed during real patient care experiences. A summary of each module is shown in Table The CPCP online curriculum was evaluated through feedback from students on the content and function of the modules and their applicability to students' clinical work. Feedback surveys addressed four areas: 1) general information on the time required to complete each module, relevance of the learning objectives, and appropriateness of the online format; 2) applicability of the modules' content to the students' clinical work; 3) module technical performance; and 4) the modules' most and least valuable parts. The first three sections contained Likert scale responses; the questions about the most and least valuable parts of each module were answered in free text. Student responses to the first three sections were tabulated and the percentage indicating each possible response calculated. Comments from section four were reviewed for recurrent themes.At the end of the third year of medical school, all CPCP students and a convenience sample of students in the traditional curriculum who had no exposure to the CPCP online curriculum or preceptorship completed a 15 station Objective Structured Clinical Examination whose content was based on the CPCP curricular objectives. Stations assessed students' history-taking, physical exam, medical knowledge and patient education skills.Scores on the exam were collected and analyzed using the SPSS statistical package, v. 14.0. Mean scores on the USMLE Part 1 exam of PCT and control students were compared using ANOVA to look for baseline academic differences between the groups. Levene's test for Equality of Variances was performed on OSCE scores to determine whether the variances between the two groups differed significantly. T-tests were then performed to compare the overall performance of CPCP students and controls, as well as the sub-scores on the history taking, physical exam and patient education stations.This study was granted "exempt" status by the Institutional Review Board of the MetroHealth Medical Center, a Case affiliate.CPCP students from the classes of 2005 (16), 2006 (36), and 2007 (37) completed 248 feedback surveys between January, 2002 and July, 2005. All participating students completed all surveys as a requirement of the program. Analysis was performed on 89 surveys for Module 1, 80 for Module 2, 44 for Module 3, and 35 for Module 4. Variation in the numbers is attributable to changes in some students' status as they joined or left the CPCP program.Survey results showed that each module, in its entirety, took most students approximately 7–9 hours to complete. Greater than 99% of students stated that the learning objectives of each module were clear and 98% agreed that they were met. Students indicated that they would preferentially choose a web-based format to learn the material in each module  with the majority of remaining students preferring small groups.The overall content of each module was rated as "excellent" or "very good" by the majority of students. The most highly rated components of each module were those that addressed concrete clinical skills such as SOAP note writing, prescription writing, and the health insurance tutorial (Module 1); adolescent confidentiality and hidden agendas (Module 2); treating childhood asthma and the differential diagnosis of URI symptoms (Module 3); and obesity and smoking prevention (Module 4).Table The technical performance of all components of all four modules was rated as excellent or very good by >70% of students except for the streaming video in Module 3 (54%) and Module 4 (46%) and the streaming audio in Module 4 (45%). More than 75% of students found the modules easy to navigate and more than 80% found the amount of explanation adequate to perform the required tasks.A total of 41 CPCP students took the Generalist OSCE exam at the end of their second year of the curriculum corresponding to the end of the third year of medical school. Nine volunteer students comprised the control group.There were no statistical differences between CPCP students  and controls  on the USMLE Part 1 exam.p = .86). Independent samples t-tests on overall exam scores revealed that CPCP students  scored higher than the control group . At an alpha level of .05, this difference was found to be statistically significant, t (48) = 2.08, p = .043 (two-tailed).Levene's test for Equality of Variances indicated that variances between the two groups on the gOSCE do not differ significantly (p = 0.097), but these differences were not statistically significant.Analyses of the subsections  show a trend toward better performance in CPCP students than in controls, especially in the patient education section (The use of blended learning is not new, but in the past it consisted primarily of didactic sessions or small groups to bring students in disparate clinical environments together. Using a computer-based model incorporating adult learning principles allows more student flexibility and can present material that simulates actual clinical encounters. Students can work through the material in the way that best suits their learning styles.Creating online materials allows for a level of creativity absent from writing syllabi or paper cases. We found that the variety of learning activities we could construct was only limited by our imaginations. Striving for the maximum interactivity allowed us to actively engage the students, and their feedback shows that they found the experience to be educationally valuable.Based on student feedback surveys, we found that the online curriculum was well accepted, despite the extra time students spent to complete it. This likely relates to the students' ability to work on new skills and directly apply them to their work with patients. Having an interactive virtual chart allowed students to practice note and prescription writing on their own, away from the time pressures of the clinical setting. Likewise, seeing approaches to challenging patient interviews online gave students the opportunity to increase their comfort level with such patients and to reflect on their own skills outside of real clinical encounters.More advanced students could use the curriculum to explore common primary care complaints and their differential diagnoses, tests, and treatments. Some students, however, commented that the information in Module 3 was presented at too basic a level. Reviewing the content with an eye toward its applicability to a wider range of diagnostic abilities might have improved the experience for clinically advanced students.Although all Case medical students are issued identical laptop computers on matriculation, there were still technologic issues. Some students with slow internet connections at home had trouble viewing the streaming video and listening to the streaming audio. With the increasing availability and affordability of high-speed internet connections, this problem should become less pressing. For medical schools that don't provide or require specific computer specifications, however, care must be taken in creating content that can be used by all students.There are strengths and limitations to all educational formats, and blended learning is no exception. We have highlighted the ability of an online curriculum to enhance clinical learning by taking advantage of interactive technology and standardizing student experiences in a way that is not place or time dependent. One obvious weakness is the distant nature of the interactions between students and teachers when communicating via discussion board or email. This is balanced, in CPCP, with the face-to-face interactions that the students have weekly with their preceptors. There is also a limited amount of flexibility in the content delivered to individual students. We addressed this by including as many links to further reading and related information as possible so each student could find content that suited his/her level of expertise.The major limitation to this study is the difficulty in measuring behavioral outcomes. Due to the small number of control students as well as the large number of other clinical experiences during the two years of CPCP participation that could have influenced student performance on the clinical exam, sweeping conclusions are not possible. We were encouraged to see that PCT students performed well on the exam when compared with their peers and that there was a trend toward superior performance in patient counseling and a significant difference in overall performance. The strength of the blended learning model may not be reflected as clearly in performance data as it is in the feedback the students provide on their ability to use the knowledge gained to improve the actual care of patients.In addition, when Case underwent a major curricular revision in 2006, CPCP and the online curriculum were expanded to include all second year medical students. This expansion of CPCP from an elective for primary care track students to a mandatory course further exemplifies the success of this program.In summary, a blended learning course using an interactive online curriculum to augment clinical learning in a longitudinal primary care preceptorship was successful in engaging second and third year medical students. Participants rated the content and the format highly and found that they could use the information gained in their real clinical lives. We attribute this success to the creative use of computer technology and the practical nature of the material. Medical educators should consider the blended learning format as they strive to standardize the clinical learning of their students.The authors declare that they have no competing interests.LL was the director of the CPCP program and led the development of the web-based modules. She analyzed the student feedback data, contributed significantly to the development of the Generalist OSCE exam and was involved in the analysis of the student scores, and was a major author of this manuscript. MS became the director of the CPCP program after LL left Case Western Reserve University. She contributed to the analysis of student feedback and Generalist OSCE data and was a major author of this manuscript. BB was the educational designer of the CPCP curriculum and created the structure for delivering the content and for collecting student feedback data. She contributed to the writing of this manuscript and in reviewing it carefully for important content. PG was the administrative head of the Primary Care Track program that included CPCP. She contributed significantly to the implementation of the Generalist OSCE exam and to the collection of data on student performance. She contributed to this manuscript by reviewing it carefully for intellectual content.The pre-publication history for this paper can be accessed here:


Literature shows that not only are traffic injuries due to accidents, but that there is also a correlation between different chronic conditions, the consumption of certain types of drugs, the intake of psychoactive substances and the self perception of risk  and the impact/incidence of traffic accidents. There are few studies on these aspects in primary health care.objectives of our study are:The Main aim: To outline the distribution of risk factors associated with Road Traffic Injuries (RTI) in a driving population assigned to a group of primary health care centres in Barcelona province.Secondly, we aim to study the distribution of diverse risk factors related to the possibility of suffering an RTI according to age, sex and population groups, to assess the relationship between these same risk factors and self risk perception for suffering an RTI, and to outline the association between the number of risk factors and the history of reported collisions.Design: Cross-sectional, multicentre study.Setting: 25 urban health care centres.Study population: Randomly selected sample of Spanish/Catalan speakers age 16 or above with a medical register in any of the 25 participating primary health care centres. N = 1540.Unit of study: Basic unit of care, consisting of a general practitioner and a nurse, both of whom caring for the same population .Instruments of measurement: Data collection will be performed using a survey carried out by health professionals, who will use the clinical registers and the information reported by the patient during the visit to collect the baseline data: illnesses, medication intake, alcohol and psychoactive consumption, and self perception of risk.We expect to obtain a risk profile of the subjects in relation to RTI in the primary health care field, and to create a group for a prospective follow-up.Clinical Trials.gov Identifier: NCT00778440. Traffic injuries are serious health problems that cause death, morbidity and disability, as well as an important impact on a country's economy . There aRTI are not coincidental, but they adhere to foreseeable factors. Medication and chronic conditions, despite not being the main implicated factors, are related to some cases -5. UsualThe alcohol consumption factor on its own is the biggest contributor to the production of serious RTIs. The use of certain types of medication and psychoactive substances may alter the driving capacity as well . In our As for health problems, the previous morbidity of the driver is considered to be a possible accident inducing factor, and some chronic health problems like diabetes mellitus, epilepsy, hearing or visual impairments, cognitive deteriorations and some psychiatric disorders have been associated with RTI. Despite this, the illness-accident relationship is not easy to consider objectively due to methodological difficulties .According to the 2006 Catalan Health Survey (ESCA'06), 21.7% of the Catalan population take some kind of medication, 69.5% of which is prescribed by a doctor, 5.5% prescribed by a pharmacist and 25% is self-medicated. Table In a study carried out on the Spanish driving population killed in a traffic accident in 1992, 45% had been taking some kind of medication during the previous year, 17% of which were taken regularly .On the other hand, a study which included 8,000 Spanish drivers showed that an estimated 10% of those killed or injured in a traffic collision had taken some kind of psychoactive substance. Moreover, an analysis by the National Toxicology Institute  during the period between 1991 and 1999 showed that in 4.382 drivers killed on the road, 54% had taken some kind of psychoactive substance and 5% had been on medication ,17. FinaSeveral review papers underline the effect of certain drugs on driving capacity such as narcoleptics or antipsychotics, anxyolitics, sedatives and hypnotics, tricycle antidepressants, lithium, (narcotic and non narcotic) analgesics and anti-migraine agents, anaesthetics, antiepileptic drugs, non steroid anti-inflammatory drugs, mio-relaxing agents, anti-Parkinson drugs, H1-antihistamines, anticolinergics and some cardiovascular drugs ,20.A recently published review paper suggests the need for research on the role of medication in road safety  , and theIn Spain, the cautionary information about the effect of drugs on driving capacities is ruled by Royal Law  1345/2007 , which nThe European Union has also dealt with problems related to medication and driving, particularly in an international project named "The Integrated Project DRUID ", which analyses the effect that the intake of medicines, medicinal herbs and psychoactive substances can have on road safety .Until the 1960's, the correlation between chronic health problems and road traffic injuries was very controversial. Different groups of researchers started to observe a correlation between collisions and injuries suffered by drivers with diabetes, epilepsy, cardiovascular illnesses, alcoholism and mental disorders .Some ongoing studies are currently studying the effect that diverse long-term conditions and age, elements that usually go together, can have on the incidence of RTIs .The Catalan Accident Statistics Annual Report (2003) indicates that in 7.6% of the collisions with victims, drivers suffered from the sudden appearance of an illness . This saIn our country, few articles have been published on RTI and their impact in Primary Health care. Most of them, written during the 1990's have consisted of descriptive epidemiological studies on the impact of road traffic injuries on the number of emergency consultations, its prevalence according to age groups and gender and studies on time, place and gravity of the RTI. If summarised, they show that the frequency of RTI is approximately 8 per 1,000 inhabitants ,36 makinThe most serious RTI happen on the road, and affect male drivers more (approximately 70%), with an average age of 27 ± 3 years -37, withDiverse authors warn of the high occurrence of RTI in children  , and theThere are different theoretical explanations which try to predict the change in the prevention behaviour of populations. Of all the analysed theories , the so Several studies have aimed at describing the risk perception in relation to risky driving behaviours , culturaAvailable publications show several methods to measure the risk perception for an RTI. Likert scales with closed questions and a scale between complete disagreement to complete agreement have been used in some cases , as wellThe available research in this field has been revised and a consensus that included recommendations to carry out epidemiological studies in different areas provided. Given the current situation, studies that inform us of the situation at a level closest to the patient  are essential. As are studies that permit us to set out risk levels based on a description of exposition to drugs, riskful behaviour  and chronic and acute health conditions, and studies that assess the RTI risk perception of drivers.On the other hand, the prospective group follow-up can give us an idea of the changes that may appear in terms of RTI risk factors, and in terms of traffic collisions with/without injuries. Without a doubt, this is useful information in the planning of preventative interventions in primary health care.Main aim: to assess the distribution of the risk factors associated with RTI in a driving population assigned to a group of participating primary health care centres in the city of Barcelona.Secondary objectives: 1. To study the distribution of RTI risk factors relative to medications, illnesses, alcohol intake and/or consumption of psychoactive substances in the driving population in different groups according to age and gender. 2. To outline the correlation between the number of risk factors related to suffering an RTI and the background of registered collisions, having or not having recieved medical attention. 3. To assess the existing relationship between the self perception level of risk of RTI and the presence of chronic health conditions, medication or consumption of psychoactive substances.Cross-sectional and multicentre study.25 primary health care centres in Barcelona.Drivers aged 16 or above who have been attended and who have a clinical register at the participating primary health care centres.The calculation was carried out using the population of men and women with a driving license in the Barcelona province from the age 16 and over, according to the 2005 census of drivers made available by the General Traffic Department (DGT). For sample calculation purposes, four age groups proportional to women and men were created. Accepting an alpha risk of 0.05 with a precision of +/- 0.05 percentage units in a bilateral contrast for an estimated proportion of 0.5, a random population sample of 385 subjects was determined for each age group. The total sample size is 1540 subjects  for any motive, will be invited to participate. They will be informed by the collaborating researcher (patient information leaflet) and asked to take part in the study and in yearly follow-ups via telephone. In case of acceptance, they will read and sign a consent form. Each centre will recruit patients until reaching the number of participants stipulated, taking into account the necessary distribution by age groups and sex. Figure aged 16 or above; sufficient understanding and knowledge of Catalan or Spanish; possession of valid driving or motorbike license; subject's agreement to participate in the study and in yearly follow ups via telephone through a signed consent form.people who do not poses a telephone contact number; those with serious psychiatric problems; those with physical or psychiatric disabilities that impede their participation in the study; those with a terminal illness.To date, at the end of the recruitment period, 25 practices will participate in the study.All centres of Barcelona province and the metropolitan area will be invited to participate, and those who voluntarily accept to participate will be included in the study. In the inclusion visit, the health professional will gather the relevant medical data and history  from the patient's clinical record, after checking and completing it together with the patient. Then, relevant data on behaviour and risk-perception of suffering from an RTI, and data on previous traffic accidents will be collected.A yearly follow up via telephone is expected to be performed.-A survey, which will be carried out by health professionals in a face to face interview. Data will be obtained from the clinical register, and double-checked by the researcher and patient during the visit.In this survey, the following will be noted: 1. Demographic data: age, gender, civil status, place of origin, level of studies, social class (according to the categories proposed by the Spanish Epidemiology Society). 2. Medication: long-term medication, acute medication (taken in the last 30 days). 3. Chronic health conditions related to higher risk of RTI ; need for a sick leave due to traffic injuries (Yes/No/duration); after-effects (Yes/No/type); approximate material costs/vehicle repairs needed (Yes/No/Costs). 2. Newly diagnosed long-term conditions (in the last year). 3. Chronic and acute medication recently taken (time taken and coded according to therapeutic risk group). 4. Self-reported consumption of psychoactive substances. 5. Changes in driving conditions: type of vehicle usually driven, time spent driving in hours per week; type of road usually used ; safety behaviour . 6. Changes in level of self-perception of risk (as reported by the subject of study).The characteristics of the population will be outlined using a descriptive univariant analysis, calculating the average, standard deviation, median, minimum and maximum values for continuous variables, and frequency and percentages for categorical variables.The results of the descriptive part will be expressed with their confidence interval (CI 95%). In order to investigate the distribution of the risk factors associated with suffering an RTI according to age and gender, bivariant comparisons will be carried out using the Chi-square test between categorical variables and the Student's t-test between continuous and categorical variables. In order to analyse the association between the risk perception of an RTI (low/medium/high) and the different risk factors considered, an unconditional binary logistical regression model will be implemented. For the risk perception considered as an ordinal scale, a multiple lineal regression will be implemented. For the selection of the variables for the multivariate model, the methodology proposed by Hosmer-Memeshow , Cobo 5 and GreeAll statistical tests will be carried out with a confidence level of 95% and supposing a bilateral contrast. The analyses with be carried out using the statistics package SPSS.The variables collected during the interview with the health professional will be reviewed and checked against the patient's clinical record during the same visit. Coordination meetings will be held with the collaborating researchers periodically. Any confusing or missing data will be revised by one of the investigators who will ask for explanations from the relevant investigator. Data collection booklets will be read using Teleform technology. The introduction of the data into the database as well as quality control will be carried out by a trained person with ample experience using Teleform. The interviewers carrying out the telephone interview will be trained and accredited periodically in order to ensure the maximum quality of data collection.In this study the relationship of risk factors of suffering an RTI will be evaluated; however, this does not apply to causality assessment, which would need a different specific study design.There may be subjects who, although are assigned to one of the participating centres, do not have an open clinical register there because it is the first time they have visited the clinic or because the record is on paper. In these cases, the clinical data will be collected during the inclusion visit.The computerised clinical registers (eCAP™ software or similar) may not be correctly updated in some cases, due to their recent addition to the clinic. The researchers will complete the information in the inclusion visit and through the telephone interview.There are some difficulties related to the measuring instrument (telephone interview and face to face interview), for ethical and legal reasons (consent form) as well as validity . The researcher will carry out a pilot study to rate the difficulties in completing the survey.Only those health and medication problems more often found in our field will be analysed in this study.Alcohol intake and the consumption of psychoactive substances will be considered self reported. Biological tests will not be carried out because the objective is to obtain the data under the same conditions of actual clinical practice carried out in primary care visits.The generalisation of the results will be limited to an urban population.The study will be carried out according to the principles contained in the Helsinki Declaration and its successive reviews and the Good Clinical Practice standards. The LESIONAT study protocol obtained approval from the corresponding Ethics Committee (CEIC IDIAP Jordi Gol).Consent form: the information will be provided verbally and in writing. The study subjects will have sufficient opportunity to ask about study details. Printing of the consent form will follow the rules contained in the Helsinki declaration as stipulated in article 12 under the first title of the Royal Decree 15/1999.Data confidentiality: in this study, only researchers and monitors/auditors will have access to the information on the participating subjects.There are various motives that justify the importance of this study. Primary health care is an advantageous location to carry out preventive interventions in RTI. In our country, according to data provided by the Primary Health Care Information System, 75% of the population consults a general practitioner at least in their life, and the average number of visits is between 5 and 6 yearly. Furthermore, public health cover in Spain is practically universal. This makes primary health care an ideal place for the study and implementation of preventive measures in the RTI field. These could include warnings from the side effects of certain medication, the effects of psychoactive substances on driving skills to the importance of the control and monitoring of chronic or acute illnesses that help the patient elaborate a real reception of their physical state and capacity to drive -62.RTI pose health problems that are extremely high in magnitude and in social and health repercussions. The Catalan Public Health Plan contemplates this intervention as a priority objective, and so establishes the following main aims for 2010: 1. To reduce by 20% the mortality rate associated with RTI in the main 3 population groups where they are most frequent (see introduction). 2. To reduce by 50% the mortality rate associated with RTI in men and women from 15 to 24 years old. 3. To reduce by 50% the mortality rates associated with RTI in drivers linked to an excessive intake of alcohol. 4. To reduce by 25% the prevalence of severe injuries associated with RTI in the 3 main population groups (see introduction).The elements evaluated in this study , are often managed in the Primary Care field and are therefore registered in medical records. Moreover, these are aspects that are inherently related to the Primary Health Care field which means that the date is quite complete and difficult to attain in other existing registers.The improvement in the basic knowledge of risk levels of suffering from an RTI that this study aims to achieve is a necessary first step for the definition of preventative activities in primary health care in the near future.The research team sets out the possibility of creating a group with the population group, and establishing telephone monitoring within it to investigate the prospective appearance of RTI, and the factors associated with them. With this idea, the included subjects will be asked for their consent, and to provide a contact phone number and a preferred time of day for posterior contact.Regarding the bibliographic impact of this study and after thoroughly reviewing the available bibliography, we did not find any studies similar to the project that we propose. Therefore, we believe that the originality of the questions that we raise  provided added value.The authors declare that they have no competing interests.CM, DP, JB, LR, XM, CP, XB, LG, FM and MB, form the nucleus of the team of researchers in the LESIONAT study research Group. SV, NS and EB took responsibility for the maintenance of the database, as well as processing the manuscript. SV reviewed the long-term conditions section, and NS the long-term drugs references. All of the authors read and approved the final manuscript.LESION por Accidente de Trafico en atención primaria"* "LESIONAT": Niveles de Riesgo de sufrir una The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/136/prepub


The knowledge translation field is undermined by two interrelated gaps – underdevelopment of the science and limited use of research in health services and health systems decision making. The importance of context in theory development and successful translation of knowledge has been identified in past research. Additionally, examination of knowledge translation in the long-term care (LTC) sector has been seriously neglected, despite the fact that aging is increasingly identified as a priority area in health and health services research.The aims of this study are: to build knowledge translation theory about the role of organizational context in influencing knowledge use in LTC settings and among regulated and unregulated caregivers, to pilot knowledge translation interventions, and to contribute to enhanced use of new knowledge in LTC.This is a multi-level and longitudinal program of research comprising two main interrelated projects and a series of pilot studies. An integrated mixed method design will be used, including sequential and simultaneous phases to enable the projects to complement and inform one another. Inferences drawn from the quantitative and qualitative analyses will be merged to create meta-inferences.Outcomes will include contributions to (knowledge translation) theory development, progress toward resolution of major conceptual issues in the field, progress toward resolution of methodological problems in the field, and advances in the design of effective knowledge translation strategies. Importantly, a better understanding of the contextual influences on knowledge use in LTC will contribute to improving outcomes for residents and providers in LTC settings. In this issue of Implementation Science we present study protocols for the Translating Research in Elder Care (TREC) program of research. We include an overview of the program (this paper), as well as protocols for the two major interrelated projects within the TREC program which were launched in 2008 and 2009 ,2.i.e., organizational setting and environmental factors) on knowledge translation, and the subsequent impact of knowledge translation on resident health outcomes (and secondarily on provider and system outcomes) in long-term care (LTC) facilities (nursing homes) in Canada's three Prairie Provinces. In this protocol series, we primarily use the term 'knowledge translation'. While we are aware of important differences in meaning between terms and of significant terminology confusion in the field .There is a significant burden at the present time that will increase in the near future. In 2006, 13.7% of the Canadian population was over 65 years of age ; this prThe proportion of older Canadians who live in LTC facilities has remained stable at about 4.5% over the last two decades, and as the number of older adults in the population rises, so does the number of older adults in LTC ,38. SomeSeveral reports at the international , nationaLTC facilities have several features which make them suitable environments for studying knowledge translation. First, the facilities have sufficient but not excessive variation in critical variables, such as resident population, size, funding models, and the like across the Prairie Provinces. Second, the workforce includes both regulated and unregulated caregivers. Little attention has been paid to knowledge translation in the latter group. Third, the implementation of the RAI MDS-2.0 system is sufficiently advanced in the prairies to allow us stable outcome assessments at the resident level. Fourth, little knowledge translation work has been undertaken in these settings, and systematic efforts to improve quality of care lag behind those in acute and primary care. Balanced against this is a serious lack of resources in this sector, suggesting an urgent need for innovative interventions, designed to maximize impact and minimize resource demands. These features create a valuable natural laboratory within which to study important contextual differences and develop innovative strategies to improve knowledge translation.Data will be collected in a variety of forms during the course of the TREC research program. Data collected during project one will be generated from web-based surveys (regulated care providers and managers) and computer-assisted personal interviews (CAPI) for unregulated care providers. Facility- and unit-level data will be collected in structured interview format using standardized forms. Resident data will be obtained from the custodians of the routinely collected RAI-MDS 2.0. Project two data will be collected using non-participant observation, focus groups, one-to-one interviews, family diaries, facility and unit documents, and photographs of relevant artefacts and/or non-resident care activities. Details of the data types and the collection methods used in both projects one and two are contained in the respective protocols ,2. ProtoAll data will be stored on secure servers at the University of Alberta and will be managed centrally in accordance with agreed to Canadian Tri-Council standards . Data quThe TREC program draws on multiple sources of data and is based on a fully integrated mixed method design  is shown to be an important part of organizational context in project one, but has not surfaced in project two; by feeding this information to the investigators of project two, they can not only probe for it but also explore more deeply why it may be important.The value added in this program of research comes from our ability to integrate data and analyses from multiple sources using multiple methods. The primary reason for using mixed methods is to allow us to converge on organizational context, and thus advance theory that maps organizational context and knowledge translation -51. We wAdditionally, mixed methods assist in elaborating and clarifying results by capitalizing on method strengths and reducing potential method biases. This principle also applies to the examination of different levels of similar phenomena – as is the case when we undertake multi-level data collection and modeling. Combining qualitative and quantitative data and using iterative waves of data collection from multiple sources over time will provide a more complete view of organizational context.Ethics approvals for the two TREC main projects have been received from the appropriate university ethics boards: Universities of Alberta , Calgary (#E21379), Manitoba , Saskatchewan , and Regina (REB#08-81).A focus on how the results of research projects will return on the initial investment of research dollars is increasingly expected in research programs. Often this is understood as knowledge translation or integrated knowledge translation. We anticipate return will come in two main areas – the research community and the LTC sector. As such, we are engaged in both mode one  and mode two (partnerships with policy- and decision-makers) mechanisms of knowledge production and translation .Traditional scholarly activities will include presentations at scientific conferences and publications in peer-reviewed journals, and will also occur through active participation of investigators on research and/or policy committees and groups in relevant areas.Return on investment in the LTC sector relates to enabling timely use of relevant research findings in the LTC sector. The objectives of TREC in relation to return on investment in the LTC sector are:1. To ensure that facilities participating in the research learn from the research undertaken in their facility in ways that are meaningful to them2. To establish processes where all facilities within the organizations supporting TREC research  learn from research undertaken within TREC in ways meaningful to them3. To contribute to creating sustainable enhanced capacity within the LTC sector to provide excellent care and support informed by research evidenceOur work has a horizon that extends beyond the five years of this study and beyond the designated study sites. This long-term endeavour will be done in collaboration with the sector; TREC can be considered one catalyst for a larger vision related to system improvements. In the short term, we will focus on the study facilities, with a view to enabling enhanced research use in facilities in the three involved provinces. Mechanisms to work toward this vision include:1. Engagement with decision makers: Decision makers from the three Prairie Provinces are involved as partners in TREC. They participate actively in planning and strategic sessions. Strategies are also being developed in collaboration with the sector to get direct input from frontline staff.e.g., in-person, in brief written form, using posters) with both site administrators and frontline staff.2. Timely sharing of research results in ways that are useful to staff in the LTC sector: Working with our sector partners, feedback and results from the research program are being shared in a regular and ongoing manner and in mutually agreed ways .3. Collaboration with organizations with a mandate or interest in enhancing research use capacity: Participating in one research program will not ensure ongoing capacity enhancement. Discussions are ongoing with organizations that are interested in collaborating to build sustainable capacity to use research findings in the LTC sector (4. Strategic dissemination: This will include dissemination of 'plain language' results and other information relevant to policy makers and organizations that influence care of the elderly. Strategic dissemination will be planned by the research team and sector partners, jointly.We have an opportunity to build research capacity in both the knowledge translation and LTC fields by providing an enriched training environment. Several trainees at both the doctoral and post-doctoral levels are currently engaged in the research program, and other trainees will be recruited throughout the duration of the program. When feasible, they will be actively involved in aspects of the program beyond their own work, such as project administration and interaction with decision makers.The products resulting from the various projects described here will contribute to: integration and theory development across disciplines; identifying and resolving major conceptual problems in the field, similar to Van de Ven's work  in innovThe authors declare that they have no competing interests.CAE is the principal investigator for the TREC research program. She conceived the program and its design, secured its funding, is providing the leadership and coordination for the program, and provided substantial commentary to the final submitted manuscript. AMH and JES are trainees within the TREC research program and made significant contributions to drafting the manuscript. DM, GGC, LD, JMB and PGN participated in designing the study, securing grant funding, and provided critical commentary to the final submitted manuscript. CAE and PGN co-lead project one and LD is the lead investigator for TREC project two. LD, DM, GGC are provincial site leads for Manitoba, Saskatchewan, and Alberta respectively. All authors read and approved the final submitted manuscript.


There exist individual, institutional and national barriers to change, none more so than when introducing new therapies into medical practice especially those that involve organizational change. This paper, presented as an address to the joint meeting of the Association of British Neurologists and the Indian Academy of Neurology in October 2007, explores these barriers in the context of the instruction of thrombolytic therapy for patients with acute ischaemic stroke and suggests how they might be overcome using evidence from relevant clinical trials and observational studies. The notion that revascularizing the ischemic brain might improve outcome in stroke patients is in itself deceptively simple to the point of being naïve; yet this idea, along with the equally simple notion that sleeping neurons, as opposed to dead neurons, might be woken up by restoration of oxygen and glucose, remains the bedrock of therapy in acute ischemic stroke. Without these measures it is unlikely that other protective modalities will prove effective.That there is a significant burden from acute stroke is another given, with stroke being the third most common cause of death worldwide and the most common cause of persisting disability. In the UK incidence rates for first ever stroke are between 119 – 203/100,000; in India rates are probably comparable in urban communities but possibly double in rural areas with hypertension being the most common risk factor leading to more hemorrhagic stroke than would be expected in the West. Given the size of the population, this translates into a vastly greater prevalence of stroke-related disability in India than in the United Kingdom.It is against this background that attempts have to be made to reduce the burden of stroke. Without doubt, in both countries primary prevention has to take first place. However, for those treating atheroembolic stroke, there is also the challenge of translating science into action.et al. reported disappointing results in 1963 and 1964[et al.[Early attempts to introduce thrombolysis were doomed to failure because of the lack of accurate imaging techniques. Meyer 64[et al. stopped The successful introduction of new technologies requires an understanding of the barriers that exist and the availability of strategies for managing these barriers, be it at individual, local, regional, or national level.Evidence of effectiveness is of course important, but often there are other requirements that have to be met. Parallels exist with the introduction of thrombolytic therapy for myocardial infarction, where many tens of thousands were randomized in clinical trials before there was widespread acceptance of the therapy.At the level of the individual, the barriers to the acceptance of a novel therapy include lack of awareness of areas of changing practice; but this probably does not apply in stroke medicine in which, in the UK at least, there has been the widely heralded and welcome launch of the National Strategy for Stroke though with some confusion resulting from conflicting guidelines and protocols. Some individuals regard such guidelines as medicine by cookery-too rigid, biased, and impractical, and challenging their autonomy as clinicians. Others lack confidence in the guideline developer, disagree with the evidence, or disregard them as being not applicable to their patients. Other barriers to change include patient preferences, lack of time or resources, poor motivation, fear of litigation, and organizational constraints.In the field of thrombolysis there is some favorable evidence, but more is required. In North America, the NIH Study  and IST3.What is also clear is that even after completion of the clinical trials and the subsequent implementation of thrombolysis, many patients remain without access to services. In North America, no eligible patients were treated in 35% hospitals with rTPA; the use of thrombolysis was particularly low if a neurologist was not available. Female patients and African-Americans were less likely to be treated, as also the elderly, i.e., those who are most likely to benefit. By extraIn summary therefore, evidence from the trials conducted to date tell us that treatment is associated with 7% more fatal and nonfatal brain hemorrhages, 6% more early deaths but, also, 12% fewer deaths or dependent people overall. There is however significant heterogeneity between trials suggesting that caution should be exercised in interpreting the results. If the results are reliable, it means that there should be one additional patient alive and independent for every 7–10 treated patients.We still do not know what to do for people with stroke in whom IV rTPA may be of benefit but when there is no evidence to support its use, for example, those who present within 3 h of stroke onset but do not exactly meet the trial entry criteria, e.g., patients aged > 80 years, all patients who present after 3 h and within 6 h of stoke onset, patients with severe stroke or mild strokes, and those with subtle early ischemic change or leucoaraiosis on CT. In addition there are uncertainties about the delivery of hyperacute therapies within other health care systems, such as the NHS in the UK or those in rural India.6, glucose > 2.6 mmol/l and random glucose < 22 mmol/l, and international normalised ratio > 1.5 or activated partial thromboplastin time < 50.Even where evidence is missing there are ways of obtaining consensus, e.g., the Delphi technique. A recent review from the Netherlands was unabInstitutional barriers to change are rife within health care systems and related to institutional policies, the effects of changing or displacing existing practice, financial pressures, and the climate of clinical and research governance. In the UK, policy was driven by local champions until the year 2000 when stroke was introduced into the National Service Framework for older people. Implementation was haphazard and ongoing concerns about the maturity of stroke services has resulted in the development of the National Strategy for Stroke that wasThe costs associated with changes in practice can be significant but in England the introduction of thrombolysis on license has been further facilitated by an additional top-up tariff under Payment by Results, the mechanism by which NHS trusts are reimbursed for clinical activity. The costs of further research have been supported to some extent by the development of government-funded stroke research networks but new trials are heavily handicapped by the requirements of the European Research Directive, the activities of the Medicines and Healthcare products Regulatory Agency (MHRA), local research ethics committees, radiation protection agencies, the 2008 Mental Capacity Act, and sponsorship and legal agreements between organizations sponsoring and participating in research activities. The effect of these was demonstrated in a recent review of the time taken to approve research governance applications in 50 UK NHS hospital trusts; which showed that there was up to 2 years’ delay in initiating research projects.SITS-MOST (Safe Implementation of Thrombolysis in Stroke Monitoring Study) demonstrated substantial variation in the use of thrombolytic therapies across Europe. Finland has the highest uptake, with up to 30% being treated. Among the European Union countries, the United Kingdom falls in the lowest quartile. National barriers to change include those relating to resource allocation, licensing, education, and measurement of outcome. The National Institute for Health and Clinical Excellence has addressed some of these barriers in the UK and has recommended that alteplase with best supportive care is cost-effective when compared with placebo with best supportive care for people with acute stroke. For the In India, the use of thrombolytic drugs has been approved by regulatory authority and pilot studies have started, including the launch of IST3 at the All India Institute of Medical Sciences (AIIMS). Inevitably however, there are significant problems in getting patients to treating institutions on time, including poor awareness regarding stroke in the general population and the cost of the drug/treatment.In summary, a national strategy for implementation requires national guidelines and a national will to effect change. A cost–benefit analysis needs to be done. Local opinion leaders need clinical decision–making tools and help with monitoring compliance and outcomes though audit. In the UK this has been possible through the UK Stroke Strategy, which highlights the need for early identification of suitable patients by paramedical staff and their urgent transfer to expert treatment centers that are open 24 h a day. Such centers must be able to offer immediate imaging, same-day admission to a stroke unit, and access to specialist care for complex cases. Local opinion leaders receive assistance through the work of the British Association of Stroke Physicians, involvemWhat, then, are the key messages to setting up a stroke service?Walk before you run; set up a good stroke rehabilitation unit for which there is overwhelming evidence of effectiveness, ensure you have fast access to good CT imaging, and then give people with cerebral infarction some aspirin to reduce the incidence of early stroke recurrence.Build capacity in acute stroke care; train more stroke physicians, and encourage neurologists to work with elderly care physicians.Participate in trials of IV thrombolysis that provide a governance umbrella and help train and monitor new centers.


Ischemic heart disease (IHD) affects at least 150,000 veterans annually in the United States. Lowering serum cholesterol has been shown to reduce coronary events, cardiac death, and total mortality among high risk patients. Electronic clinical reminders available at the point of care delivery have been developed to improve lipid measurement and management in the Veterans Health Administration (VHA). Our objective was to report on a hospital-level intervention to implement and encourage use of the electronic clinical reminders.The implementation used a quasi-experimental design with a comparison group of hospitals. In the intervention hospitals (N = 3), we used a multi-faceted intervention to encourage use of the electronic clinical reminders. We evaluated the degree of reminder use and how patient-level outcomes varied at the intervention and comparison sites (N = 3), with and without adjusting for self-reported reminder use.The national electronic clinical reminders were implemented in all of the intervention sites during the intervention period. A total of 5,438 patients with prior diagnosis of ischemic heart disease received care in the six hospitals (3 intervention and 3 comparison) throughout the 12-month intervention. The process evaluation showed variation in use of reminders at each site. Without controlling for provider self-report of use of the reminders, there appeared to be a significant improvement in lipid measurement in the intervention sites . Controlling for use of reminders, the amount of improvement in lipid measurement in the intervention sites was even greater . Adjusting for reminder use demonstrated that only one of the intervention hospitals had a significant effect of the intervention. There was no significant change in management of hyperlipidemia associated with the intervention.There may be some benefit to focused effort to implement electronic clinical reminders, although reminders designed to improve relatively simple tasks, such as ordering tests, may be more beneficial than reminders designed to improve more complex tasks, such as initiating or titrating medications, because of the less complex nature of the task. There is value in monitoring the process, as well as outcome, of an implementation effort. Ischemic heart disease (IHD) is one of the leading causes of death in the United States' veteran population. It affects at least 150,000 veterans annually and is the primary diagnosis in approximately one out of 17 admissions to Veterans Health Administration (VHA) hospitals  NumerousClinical practice guidelines are known to be difficult to implement. Many studies have tested interventions to improve adherence to clinical practice guidelines for a variety of conditions and in a range of settings, but even after intervention, these studies find wide variation in guideline adherence and fail to find any specific interventions consistently associated with improved adherence -18. SevePrior studies have found that reminders are not consistently used by clinicians when they are made available -30. Few In this article, we report results of an exploratory study of a multi-site, multi-faceted quality improvement intervention tailored to local contexts and designed to implement electronic clinical reminders in order to improve rates of LDL-c measurement and pharmacologic management among VA IHD patients. The study was initially planned as a first step in designing a randomized controlled trial to implement a complex intervention , and wasThis article is one in a Series of articles documenting implementation science frameworks and approaches developed by the U.S. Department of Veterans Affairs Quality Enhancement Research Initiative (QUERI). QUERI is briefly outlined in Table We conducted a quasi-experimental study using a hospital level intervention to implement electronic clinical reminders with the goal of improving hyperlipidemia management in VA IHD patients. Intervention hospitals included three VHA hospitals and their satellite clinics on the eastern side of the Rocky Mountain Network , one of 21 regional networks within VHA. Comparison hospitals, in which no efforts were made to implement or encourage the use of the national clinical reminders, were the three VHA hospitals on the western side of the Rocky Mountain Network . In both the intervention and comparison groups, one of the three hospitals is a large, urban, tertiary hospital (Sites B and F), while the other two are smaller, non-tertiary hospitals in relatively small towns . In the three intervention hospitals, the two smaller hospitals (A and C) each had two to three satellite clinics, while the large hospital had eight satellite clinics.We did not randomize sites to either intervention or comparison arms because of geographic differences between the two halves of the regional network, feasibility due to travel and budget restrictions, and because of concerns about the integrity of referral networks in each half of the regional network. This latter concern was expressed by the regional leaders who gave approval to conduct the intervention. Regional leaders advised working within the existing structure of the network as we conducted the intervention. Our original intent was to use a lagged design, introducing the intervention to the comparison half of the region following completion of the intervention in the first half. Because of delays in developing and releasing the reminders, we were not able to complete implementation in the comparison sites before the conclusion of the study period.Primary care providers, consisting of general internists, family practitioners, nurse practitioners, nurses, and/or physician assistants, were the targets of the intervention. However, as we note below in our description of the reminders, the reminders could be viewed by other providers, such as health technicians or pharmacists, within the care team. We did not include these other providers in our training or facilitation efforts.The intervention consisted of an internally and externally facilitated implementation of national electronic lipid clinical reminders to promote guideline-recommended secondary prevention for IHD and began with a kickoff meeting attended by interdisciplinary teams of three to eight primary care providers from each of the intervention hospitals Table . To ensuThe kickoff meeting included talks by local and national experts in cardiology and lipid management. Teams from each hospital participated in small group sessions reviewing known barriers and facilitators to implementing new practices within their hospitals, and discussed specific barriers and concerns about their hospitals. Participants completed surveys designed to measure their perceptions of organizational readiness to change, and discussed the aggregate findings in the context of preparing system change. They were trained in the installation and use of reminders and were provided with the necessary support to enable them to champion the implementation of the national electronic clinical reminders in their facilities.Following the kickoff meeting, bi-monthly conference calls with intermittent one-on-one phone and email contact were held between all participating intervention team members and the lead intervention teams based in Seattle and Denver. The Seattle team consisted of the principal investigator, a project director who had overall responsibility for project management and coordination, and a programmer/analyst. The Denver team consisted of the co-PI, a project manager who had primary responsibility for contact with the intervention sites, and a programmer/analyst. Through such contact, teams were able to give reports and discuss barriers encountered. Teams that had overcome some of the identified barriers offered solutions to others. The intervention period was from June 2002 (when the kickoff meeting was held) through September 2003.The two VHA national lipid clinical reminders were released in May 2002 as an addition to the VHA Computerized Patient Record System (CPRS). CPRS is a fully electronic medical record system with computerized order entry, including laboratory tests, medication ordering, and consultation . The fire.g., statins). In both cases, providers have the option of checking a box indicating that the diagnosis of IHD is inaccurate, or that they have chosen not to take recommended action based on clinical judgment.This reminder can be completed by primary care providers or ancillary clinical personnel, including nurses. The second reminder is triggered by a current LDL-c of 130 mg/dL or greater. It consists of a dialog box with options for treatment including check boxes for direct ordering of medications  were eligible for this study. Patients were identified as having IHD if they had an ICD-9-CM code of 410.xx , 411.xx (other acute and subacute forms of ischemic heart disease), 412.xx , or 414.xx (other forms of ischemic heart disease) in the VA National Patient Care Databases (NPCD), and if they had been seen in primary care in a VHA hospital at least twice in the past three years. The algorithm for patient identification has been previously described by Sloan and colleagues [Patients with a diagnosis of IHD who received care at the intervention or comparison hospitals during the observation period of September 2002 through June 2003 , which contains laboratory and other clinical information for all patient encounters. The second data source was the VA Pharmacy Benefits Management (PBM) database, which contains detailed medication data on all VHA patients. The third was the NPCD, which contains records of all inpatient admissions and outpatient encounters. The same patient-level data were available for patients in both intervention and comparison hospitals. Patient age at baseline, gender, race/ethnicity, self-reported income, and number of co-morbid conditions were used to adjust the patient level outcomes. Race/ethnicity was coded as white/non-white, where patients for whom race/ethnicity was missing in administrative data (27%) were coded non-white. We repeated the analysis coding these patients as white, or missing, and found that it did not affect the results. The following diseases were coded as co-morbidities, and each scored one in the count of co-morbid conditions: diabetes, renal disease, chronic heart failure, depression, stroke, peripheral vascular disease, and substance use disorder. These conditions have been related to lipid measurement and treatment in our prior studies. Human subjects review and approval was obtained from the relevant institutional review boards.We tracked participation in the intervention by the teams in each intervention hospital through conference calls, email messages, and other contacts with the intervention teams during the course of the intervention period. We compiled the data from the tracking system to report on barriers experienced by the intervention teams during the course of the intervention, and report these as specific events experienced in each hospital in a barriers section at the beginning of the results section.i.e., an action was taken which met the predetermined criteria for satisfying the reminder) on a weekly basis for the last half of the intervention period (May to September 2003). Reminder counts were tabulated only for the last half of the intervention period because data were only available for this period.We collected clinic-level data from each hospital detailing the number of clinical reminders due for patients, as well as the number of reminders satisfied . In the second analysis, we controlled for the degree of reminder use.For the process evaluation of the intervention, we assessed the degree to which hospitals varied in their patient and provider characteristics at baseline. We conducted a qualitative assessment of intervention team participants' views on their organizations readiness to adopt practice change. We monitored and graphed trends in lipid measurement and lipid levels among patients with IHD at the intervention sites throughout the majority of the intervention period. We reported frequency of reminder use at the intervention sites from the reports that are generated from the electronic reminders (reminder reports). We also assessed provider self-report data on their use of electronic clinical reminders, both the two IHD reminders and other locally developed reminders.2 for inference testing. We included only those IHD patients who were present in all time periods during the study period. We also conducted multivariable analysis using two multivariable logistic regression models: the first for positive change in current measurement of LDL-c , and the second for positive change in prescribing lipid lowering agents for patients with LDL-c greater than 130 mg/dL. We entered a variable indicating intervention site in the multivariable analysis, and we used a cluster correction to correct for clustering by hospital. Finally, we adjusted for provider self-report of reminder use, as this measured whether or not the reminder actually was used, rather than assuming use based on the allocation by hospital to intervention or not. All analyses were conducted using Stata version 9.0. Multivariable analyses were conducted using logistic regression with a binary dependent variable indicating improvement in measurement or lipid level, adjusted for clustering using Stata's "cluster" command. This command corrects the standard errors for the effect of autocorrelation due to hospital.For the summative or outcome evaluation, we conducted bivariate analyses comparing the change in proportion of patients with current LDL-c measurement and the proportion of patients with elevated LDL-c who were receiving lipid-lowering medication between intervention and comparison hospitals and between the beginning and end of the intervention period, using analysis of variance and the F-statistic or tabulation with χAs shown in Table Barriers included: Use of a diagnosis code that was different from those used within the reminder logic to identify IHD patients (Site C only); inability to find reminder experts who could train clinicians in their use (Site A only); lack of IT support staff to install and turn on the reminders (primarily affecting Sites A and B); and an organizational merger that took priority over all other activities (Site B only). Of note, none of the sites indicated that time for clinicians to use the reminder was a significant barrier, although time burdens are consistently cited among the most frequent barriers to clinical reminders. The passive nature of the reminders may have been a factor in limiting the degree to which reminders presented a burden for providers.Barrier resolution included changing coding practice at Site C (unknown amount of time to resolve); and scheduling a training session at Site A, with the reminder champion from Site C traveling to participate in the training to make it relevant for clinicians (three months to resolve). The two barriers encountered at Site B were not readily resolvable, although the local team and our implementation team worked diligently to ameliorate the situation. Overall, the local team member morale remained high and the teams remained engaged throughout the intervention period.The trend lines for measurement reminders due for each of the three intervention hospitals over the five-month period for which reminder reports were available is shown in Figure The provider survey data from both the intervention and comparison hospitals showed considerable variation across the sites Table . On averThere was also variation in attitudes expressed by providers, in the degree to which providers reported that the IHD reminders were useful, with intervention hospitals generally reporting that they were more useful ; that they increased awareness of the need for measurement and treatment of these patients ; and, to a lesser degree, recommended appropriate treatment or action options . There was less than maximal contrast in reminder use between intervention and control hospitals.As shown in Table The odds of treatment for patients requiring medications was somewhat lower for intervention sites after adjusting for reminder use, but remained statistically indistinguishable from comparison sites.The primary aim of this study was to explore the implementation of electronic clinical reminders in order to improve rates of LDL-c measurement and pharmacologic management among patients with known ischemic heart disease in VHA. There is no literature to date on the use of a hospital-level intervention to improve the use of electronic clinical reminders. However, consistent with prior papers reporting the results of process evaluation of a reminder intervention , we founProviders at all six sites (intervention and control) reported using reminders, although not necessarily the two specific reminders that were the subject of this implementation effort. We note that use of reminders is self-reported, and may not fully reflect actual use; in particular, providers may over-report use of reminders when asked to self-report. At the intervention hospitals, the measurement reminder (prompting the clinician to order a test measuring LDL-c when no current measurement was available in the record) appears to have been effective in increasing the proportion of patients with current LDL-c measurements. However, the treatment reminder (prompting clinicians to begin a medication when a patient was not on a lipid-lowering medication and had elevated LDL-c) appears not to have been effective, even when we took into account self-reported use of the reminder ,20,22.Data from the reminder reports suggested that the reminder due rates were not very high in the intervention hospitals, ranging from 19 to 27% for measurement and 10 to 14% for treatment  among veterans with IHD ,36,37. HThere is considerable literature on the effectiveness of reminders, much of which is undermined by not adjusting for either organizational or hierarchical variables, or for the degree of reminder use ,38,39. IFinally, our findings underscore the importance of formative and process evaluation in implementation research: first to maintain fidelity to the original intention of the intervention, and second to understand the degree of uptake of the implementation . Our proThe quasi-experimental design was an important strength of this study which allowed us to evaluate the effects of the reminders in the intervention sites adjusting for temporal trends. However, because allocation to the intervention group was non-random, there is a threat from unobserved confounders. Comparison sites were also non-optimal because they had existing electronic reminders for lipids, and temporal trends in lipid performance measures may have been different for facilities with electronic reminders versus those without. An ideal control group would have been a matched set of sites without a reminder system. In addition, we were able to obtain reminders due and satisfied (process measure) data only for part of the intervention period. However, a strength of this study is having these data at all. Also it should be noted that the response rates at each site were variable Table , a factoAlthough the data suggest that the implementation effort may have had some impact, the effect of the implementation effort reported in this study is modest. This finding is consistent with reports of implementation efforts focused at the organizational level. Our study generated some new insights into how clinicians respond to reminders that focus on different aspects of a clinical problem, namely detection or screening versus medication initiation or intensification. This study also demonstrates the importance of including contemporary controls when evaluating quality improvement interventions. We also report some substantial barriers to implementing reminders at a facility level, including a possible significant effect of prior culture and attitudes towards reminders. Our findings suggest that assessing these factors is likely to be an essential component to successful implementation of electronic clinical reminders, and finding methods of intervening if negative attitudes or an unsupportive culture are present. It may be very important to have enough resources to respond to these barriers as part of an implementation plan.The authors declare that they have no competing interests.AS was the principal investigator of the study reported in this article, and she designed it in collaboration with other authors, supervised data collection, conducted analysis, and took the lead in drafting the manuscript, CH contributed to writing the manuscript and conducted the associated literature review, PMH participated in design, data collection, and writing the manuscript, AH was the project coordinator and conducted data collection and managed the intervention and survey, MEP was responsible for data extraction from VA national databases and data analysis, YFL designed the tracking database used in the process evaluation and assisted with data analysis, AC completed and updated the literature review and participated in writing the manuscript, JSR was co-principal investigator and participated as a site lead, participated in the intervention, supervised data collection and data extraction, and participated in writing the manuscript. All authors read and approved the final manuscript.VA Clinical Reminder Provider Feedback Survey. A survey given to providers in both intervention and comparison hospitals, asking them about their use of and perceptions about electronic clinical reminders generally, and the IHD national clinical reminders in particular.Click here for file