Search

Objective To appraise instruments used as primary outcome measures in trials measuring the effectiveness of patient decision support interventions. Methods Primary outcome measures were identified in trials of patient decision aids included in the 2003 Cochrane Review. Instruments were appraised for: use in calculating sample size, appropriateness, reliability, validity, responsiveness, precision, interpretability, acceptability, and feasibility. Results Of the 35 trials, there were 35 unique primary outcome measures and 8 instruments were appraised. Actual or preferred choice was the primary outcome measure in 18 trials. Two instruments met at least 6 of 8 appraisal criteria: Control Preference Scale ( n = 2 trials) and Decisional Conflict Scale ( n = 5 trials). The Decision Conflict Scale was used to calculate sample size in 4 trials. Conclusion Decision was the most consistent outcome measure. Most publications provided inadequate detail for appraising the instruments. Four instruments (Decisional Conflict, Control Preferences, Genetic Testing Knowledge Questionnaire, and McBride's Satisfaction with Decision) measured one or more International Patient Decision Aid Standards criteria for evaluating effectiveness. Practice implications Selecting relevant and high quality outcome measures remains challenging and is an important area for further research in the field of shared decision making.

The POpulation HEalth Model (POHEM) is a health microsimulation model that was developed at Statistics Canada in the early 1990s. POHEM draws together rich multivariate data from a wide range of sources to simulate the lifecycle of the Canadian population, specifically focusing on aspects of health. The model dynamically simulates individuals’ disease states, risk factors, and health determinants, in order to describe and project health outcomes, including disease incidence, prevalence, life expectancy, health-adjusted life expectancy, quality of life, and healthcare costs. Additionally, POHEM was conceptualized and built with the ability to assess the impact of policy and program interventions, not limited to those taking place in the healthcare system, on the health status of Canadians. Internationally, POHEM and other microsimulation models have been used to inform clinical guidelines and health policies in relation to complex health and health system problems. This paper provides a high-level overview of the rationale, methodology, and applications of POHEM. Applications of POHEM to cardiovascular disease, physical activity, cancer, osteoarthritis, and neurological diseases are highlighted.

Background Health behaviours, important factors in cardiovascular disease, are increasingly a focus of prevention. We appraised whether stroke risk can be accurately assessed using self-reported information focused on health behaviours. Methods Behavioural, sociodemographic and other risk factors were assessed in a population-based survey of 82 259 Ontarians who were followed for a median of 8.6 years (688 000 person-years follow-up) starting in 2001. Predictive algorithms for 5-year incident stroke resulting in hospitalization were created and then validated in a similar 2007 survey of 28 605 respondents (median 4.2 years follow-up). Results We observed 3 236 incident stroke events (1 551 resulting in hospitalization; 1 685 in the community setting without hospital admission). The final algorithms were discriminating (C-stat: 0.85, men; 0.87, women) and well-calibrated (in 65 of 67 subgroups for men; 61 of 65 for women). An index was developed to summarize cumulative relative risk of incident stroke from health behaviours and stress. For men, each point on the index corresponded to a 12% relative risk increase (180% risk difference, lowest (0) to highest (9) scores). For women, each point corresponded to a 14% relative risk increase (340% difference, lowest (0) to highest (11) scores). Algorithms for secondary stroke outcomes (stroke resulting in death; classified as ischemic; excluding transient ischemic attack; and in the community setting) had similar health behaviour risk hazards. Conclusion Incident stroke can be accurately predicted using self-reported information focused on health behaviours. Risk assessment can be performed with population health surveys to support population health planning or outside of clinical settings to support patient-focused prevention.

The objective of this study was to assess the efficacy and safety of sildenafil citrate (Viagra) in black American and Hispanic American men with erectile dysfunction (ED) of broad-spectrum etiology. A total of 246 black American and 197 Hispanic American men were randomized to sildenafil (50 mg, adjustable to 25 mg or 100 mg, depending on efficacy and tolerability; n = 124 and n = 99, respectively) or matching placebo (n = 122 and n = 98, respectively). After 6 weeks, patients were given the option of switching to the other blinded treatment for the following 6 weeks. The 12 weeks of double-blind treatment were followed by 12 weeks of open-label extension. Despite differences in prevalence of hypertension, diabetes mellitus, hyperlipidemia, and use of concomitant antihypertensive agents between the 2 study groups, sildenafil was efficacious and well tolerated. After 6 weeks, scores for questions 3 and 4 from the International Index of Erectile Function (IIEF) were significantly higher among sildenafil-treated black and Hispanic patients than in placebo-treated patients. In addition, compared with placebo, a significantly larger proportion of sildenafil patients reported improved erections and improved ability to have sexual intercourse. When efficacy results were stratified by ED severity or number of risk factors, scores for IIEF questions 3 and 4 were lower in men with severe ED versus mild-to-moderate ED. Similarly, the percentage of patients reporting improved erections decreased with ED severity and number of risk factors. The proportion of patients switching to the other treatment after 6 weeks was significantly higher in the placebo group (71% to 85%) than in the sildenafil group (27% to 28%). The most common adverse events included headache and vasodilation, which were mild to moderate in nature and were comparable between groups. These data demonstrate that despite differences in prevalence rates of comorbidities, efficacy and safety of sildenafil is maintained across different ethnic groups.

IntroductionRecent publications have called for substantial improvements in the design, conduct, analysis and reporting of prediction models. Publication of study protocols, with prespecification of key aspects of the analysis plan, can help to improve transparency, increase quality and protect against increased type I error. Valid population-based risk algorithms are essential for population health planning and policy decision-making. The purpose of this study is to develop, evaluate and apply cardiovascular disease (CVD) risk algorithms for the population setting.Methods and analysisThe Ontario sample of the Canadian Community Health Survey (2001, 2003, 2005; 77 251 respondents) will be used to assess risk factors focusing on health behaviours (physical activity, diet, smoking and alcohol use). Incident CVD outcomes will be assessed through linkage to administrative healthcare databases (619 886 person-years of follow-up until 31 December 2011). Sociodemographic factors (age, sex, immigrant status, education) and mediating factors such as presence of diabetes and hypertension will be included as predictors. Algorithms will be developed using competing risks survival analysis. The analysis plan adheres to published recommendations for the development of valid prediction models to limit the risk of overfitting and improve the quality of predictions. Key considerations are fully prespecifying the predictor variables; appropriate handling of missing data; use of flexible functions for continuous predictors; and avoiding data-driven variable selection procedures. The 2007 and 2009 surveys (approximately 50 000 respondents) will be used for validation. Calibration will be assessed overall and in predefined subgroups of importance to clinicians and policymakers.Ethics and disseminationThis study has been approved by the Ottawa Health Science Network Research Ethics Board. The findings will be disseminated through professional and scientific conferences, and in peer-reviewed journals. The algorithm will be accessible electronically for population and individual uses.Trial registration numberClinicalTrials.gov NCT02267447.

In 2012, the Veterans Health Administration (VHA) implemented guidelines seeking to reduce PSA-based screening for prostate cancer in men aged 75 years and older.To reduce the use of inappropriate PSA-based prostate cancer screening among men aged 75 and over.The Veterans Affairs Greater Los Angeles Healthcare System (VA GLA) PROGRAM DESCRIPTION: We developed a highly specific computerized clinical decision support (CCDS) alert to remind providers, at the moment of PSA screening order entry, of the current guidelines and institutional policy. We implemented the tool in a prospective interrupted time series study design over 15 months, and compared the trends in monthly PSA screening rate at baseline to the CCDS on and off periods of the intervention.A total of 30,150 men were at risk, or eligible, for screening, and 2,001 men were screened. The mean monthly screening rate during the 15-month baseline period was 8.3%, and during the 15-month intervention period, was 4.6%. The screening rate declined by 38% during the baseline period and by 40% and 30%, respectively, during the two periods when the CCDS tool was turned on. The screening rate ratios for the baseline and two periods when the CCDS tool was on were 0.97, 0.78, and 0.90, respectively, with a significant difference between baseline and the first CCDS-on period (p 0.0001), and a trend toward a difference between baseline and the second CCDS-on period (p = 0.056).Implementation of a highly specific CCDS tool alone significantly reduced inappropriate PSA screening in men aged 75 years and older in a reproducible fashion. With this simple intervention, evidence-based guidelines were brought to bear at the point of care, precisely for the patients and providers for whom they were most helpful, resulting in more appropriate use of medical resources.

BACKGROUND Reductions in preventable risks associated with cardiovascular disease have contributed to a steady decrease in its incidence over the past 50 years in most developed countries. However, it is unclear whether this trend will continue. Our objective was to examine future risk by projecting trends in preventable risk factors in Canada to 2021. METHODS We created a population-based microsimulation model using national data on births, deaths and migration; socioeconomic data; cardiovascular disease risk factors; and algorithms for changes in these risk factors (based on sociodemographic characteristics and previous cardiovascular disease risk). An initial population of 22.5 million people, representing the Canadian adult population in 2001, had 13 characteristics including the risk factors used in clinical risk prediction. There were 6.1 million potential exposure profiles for each person each year. Outcome measures included annual prevalence of risk factors (smoking, obesity, diabetes, hypertension and lipid levels) and of co-occurring risks. RESULTS From 2003 to 2009, the projected risks of cardiovascular disease based on the microsimulation model closely approximated those based on national surveys. Except for obesity and diabetes, all risk factors were projected to decrease through to 2021. The largest projected decreases were for the prevalence of smoking (from 25.7% in 2001 to 17.7% in 2021) and uncontrolled hypertension (from 16.1% to 10.8%). Between 2015 and 2017, obesity was projected to surpass smoking as the most prevalent risk factor. INTERPRETATION Risks of cardiovascular disease are projected to decrease modestly in Canada, leading to a likely continuing decline in its incidence.

Introduction Older adults living in the community often have multiple, chronic conditions and functional impairments. A challenge for healthcare providers working in the community is the lack of a predictive tool that can be applied to the broad spectrum of mortality risks observed and may be used to inform care planning. Objective To predict survival time for older adults in the home care setting. The final mortality risk algorithm will be implemented as a web-based calculator that can be used by older adults needing care and by their caregivers. Design Open cohort study using the Resident Assessment Instrument for Home Care (RAI-HC) data in Ontario, Canada, from 1 January 2007 to 31 December 2013. Participants The derivation cohort will consist of ∼437 000 older adults who had an RAI-HC assessment between 1 January 2007 and 31 December 2012. A split sample validation cohort will include ∼122 000 older adults with an RAI-HC assessment between 1 January and 31 December 2013. Main outcome measures Predicted survival from the time of an RAI-HC assessment. All deaths (n≈245 000) will be ascertained through linkage to a population-based registry that is maintained by the Ministry of Health in Ontario. Statistical analysis Proportional hazards regression will be estimated after assessment of assumptions. Predictors will include sociodemographic factors, social support, health conditions, functional status, cognition, symptoms of decline and prior healthcare use. Model performance will be evaluated for 6-month and 12-month predicted risks, including measures of calibration (eg, calibration plots) and discrimination (eg, c-statistics). The final algorithm will use combined development and validation data. Ethics and dissemination Research ethics approval has been granted by the Sunnybrook Health Sciences Centre Review Board. Findings will be disseminated through presentations at conferences and in peer-reviewed journals. Trial registration number NCT02779309, Pre-results.

Hyperglycemia is recognized as an important threat to the health of patients, independent of diabetes status. However, no long-term follow-up study of patients with in-hospital elevated glucose without diabetes has been conducted.To compare 1- and 5-year risk of death and cardiovascular (CV) complications in patients with a diagnosis of diabetes versus those without a diabetes diagnosisRetrospective cohort study.Risk of all-cause death and CV complications (acute myocardial infarction [AMI], congestive heart failure [CHF], cardiovascular disease [CVD], peripheral vascular disease [PVD], and end-stage renal disease [ESRD]) in those diagnosed with diabetes versus those with different glycemia categories was determined using competing risk models.All adult patients from a tertiary hospital discharged alive between 1996 and 2008 from any service except psychiatry or obstetrics.Compared to patients with diagnosed diabetes, patients with peak serum glucose level200 mg/dL had significantly higher 1-year risk (hazard ratio [HR]: 1.31, 95% confidence interval [CI]: 1.20-1.43) and 5-year risk (HR: 1.13, 95% CI: 1.06-1.22) of death but a decreased 1-year risk of hospitalization for CHF (HR: 0.71, 95% CI: 0.62-0.81), PVD (HR: 0.20, 95% CI: 0.18-0.24), or ESRD (HR: 0.73, 95% CI: 0.6-0.89). There was no risk difference for AMI (HR: 0.96, 95% CI: 0.78-1.18) or CVD (HR: 0.79, 95% CI: 0.61-1.0).Although it is unclear whether hospitalized patients with elevated peak serum glucose have early diabetes or their hyperglycemia reflects hospital stress or another comorbidity, in-hospital hyperglycemia is an important clinical indicator, carrying a higher 1- and 5-year mortality risk than those with diagnosed diabetes.

Background Diabetes has been described as one of the most important threats to the health of developed countries. Effective population strategies to prevent diabetes have not been determined but two broad strategies have been proposed: “high-risk” and “community-wide” strategies. Methods We modelled the potential effectiveness of two strategies to prevent 10% of new cases of diabetes in Ontario, Canada over a 5-year period. The 5-year risk of developing physician-diagnosed diabetes was estimated for respondents to the Canadian Community Health Survey 2003 (CCHS 2.1, N = 26 232) using a validated and calibrated diabetes risk tool (Diabetes Population Risk Tool [DPoRT]). We estimated how many cases of diabetes could be prevented using two different strategies: a) a community-wide strategy that would uniformly reduce body mass index (BMI) in the entire population; and b) a high baseline risk strategy using either pharmacotherapy or lifestyle counselling to treat people who have an increased risk of developing diabetes. Results In 2003, the 5-year risk of developing diabetes was 4.7% (383 600 new diagnosed cases of diabetes in 8 189 000 Ontarians aged 20+) and risk was moderately diffused (0.5%, 3.1% and 17.9% risk in the 1st, 5th (median) and 10th deciles of risk). A 10% reduction in new cases of diabetes would have been achieved under any of the following scenarios: if BMI was 3.5% lower in the entire population; if lifestyle counselling covered 32.2% of high-risk people (371 900 of 1 155 000 people with 5 year diabetes risk greater than 10%); or, if pharmacotherapy covered 65.2% of high-risk people. Conclusions Prevention using pharmacotherapy alone requires unrealistically high coverage levels to achieve modest population reduction in new diabetes cases. On the other hand, in recent years few jurisdictions have been able to achieve a reduction in BMI at the population level, let alone a reduction of BMI of 3.5%.

Background The prevalence of multiple chronic diseases is increasing and is a common problem for primary health care providers. This study sought to determine the patient and health system burden of multiple chronic diseases among adults in Ontario, Canada, with a focus on the ambulatory health care system (outpatient primary health care and specialist services). Methods This population-based study used linked health administrative data from Ontario, Canada. Individuals, aged 20 years or older, who had a valid health card, were included. Validated case definitions were used to identify persons with at least one of the following nine chronic diseases: diabetes, congestive heart failure, acute myocardial infarction, stroke, hypertension, asthma, chronic obstructive lung disease, peripheral vascular disease and end stage renal failure. Prevalence estimates for chronic diseases were calculated for April 1, 2009. Ambulatory physician billing records for the two-year period, April 1, 2008 to March 31, 2010, were used to identify the number of outpatient ambulatory care visits. Results In 2009, 26.3% of Ontarians had one chronic disease, 10.3% had two diseases, and 5.6% had three or more diseases. Annual mean primary health care use increased significantly with each additional chronic disease. Overall, there were twice as many patient visits to primary health care providers compared to specialists across all chronic disease counts. Among those with multiple diseases, primary health care visits increased with advancing age, while specialist care dropped off. While persons with three or more diseases accounted for a disproportionate share of primary health care visits, the largest number of visits were made by those with no or one chronic disease. Conclusions The burden of care for persons with multiple chronic diseases is considerable and falls largely on the primary health care provider. However persons with no or one chronic disease are responsible for the largest number of ambulatory health care visits overall. Continued investment in primary health care is needed both to care for those with multiple diseases and to prevent the accumulation of chronic diseases with aging.

Objective. The IPDAS Collaboration has developed a checklist and an instrument (IPDASi v3.0) to assess the quality of patient decision aids (PDAs) in terms of their development process and shared decision-making design components. Certification of PDAs is of growing interest in the US and elsewhere. We report a modified Delphi consensus process to agree on IPDASi (v3.0) items that should be considered as minimum standards for PDA certification, for inclusion in the refined IPDASi (v4.0). Methods. A 2-stage Delphi voting process considered the inclusion of IPDASi (v3.0) items as minimum standards. Item scores and qualitative comments were analyzed, followed by expert group discussion. Results. One hundred and one people voted in round 1; 87 in round 2. Forty-seven items were reduced to 44 items across 3 new categories: 1) qualifying criteria, which are required in order for an intervention to be considered a decision aid (6 items); 2) certification criteria, without which a decision aid is judged to have a high risk of harmful bias (10 items); and 3) quality criteria, believed to strengthen a decision aid but whose omission does not present a high risk of harmful bias (28 items). Conclusions. This study provides preliminary certification criteria for PDAs. Scoring and rating processes need to be tested and finalized. However, the process of appraising the quality of the clinical evidence reported by the PDA should be used to complement these criteria; the proposed standards are designed to rate the quality of the development process and shared decision-making design elements, not the quality of the PDA’s clinical content.

Background Surgeries and other procedures can influence the risk of death in hospital. All published scales that predict post-operative death risk require clinical data and cannot be measured using administrative data alone. This study derived and internally validated an index that can be calculated using administrative data to quantify the independent risk of hospital death after a procedure. Methods For all patients admitted to a single academic centre between 2004 and 2009, we estimated the risk of all-cause death using the Kaiser Permanente Inpatient Risk Adjustment Methodology (KP-IRAM). We determined whether each patient underwent one of 503 commonly performed therapeutic procedures using Canadian Classification of Interventions codes and whether each procedure was emergent or elective. Multivariate logistic regression modeling was used to measure the association of each procedure-urgency combination with death in hospital independent of the KP-IRAM risk of death. The final model was modified into a scoring system to quantify the independent influence each procedure had on the risk of death in hospital. Results 275 460 hospitalizations were included (137,730 derivation, 137,730 validation). In the derivation group, the median expected risk of death was 0.1% (IQR 0.01%-1.4%) with 4013 (2.9%) dying during the hospitalization. 56 distinct procedure-urgency combinations entered our final model resulting in a Procedural Index for Mortality Rating (PIMR) score values ranging from -7 to +11. In the validation group, the PIMR score significantly predicted the risk of death by itself (c-statistic 67.3%, 95% CI 66.6-68.0%) and when added to the KP-IRAM model (c-index improved significantly from 0.929 to 0.938). Conclusions We derived and internally validated an index that uses administrative data to quantify the independent association of a broad range of therapeutic procedures with risk of death in hospital. This scale will improve risk adjustment when administrative data are used for analyses.

Objective To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. Design Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. Data sources A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8. Results There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals. Conclusion The quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology.

Dietary sodium reduction is commonly used in the treatment of hypertension, heart and liver failure, and chronic kidney disease. Sodium reduction is also an important public health problem since most of the Canadian population consumes sodium in excess of their daily requirements. Lack of awareness about the amount of sodium consumed and the sources of sodium in diet is common, and undoubtedly a major contributor to excess sodium consumption. There are few known tools available to screen and provide personalized information about sodium in the diet. Therefore, we developed a Web-based sodium intake screening tool called the Salt Calculator ( www.projectbiglife.ca ), which is publicly available for individuals to assess the amount and sources of sodium in their diet. The Calculator contains 23 questions focusing on restaurant foods, packaged foods, and added salt. Questions were developed using sodium consumption data from the Canadian Community Health Survey cycle 2.2 and up-to-date information on sodium levels in packaged and restaurant food databases from the University of Toronto. The Calculator translates existing knowledge about dietary sodium into a tool that can be accessed by the public as well as integrated into clinical practice to address the high levels of sodium presently in the Canadian diet.

Carol Bennett and colleagues review the evidence and find that there is limited guidance and no consensus on the optimal reporting of survey research., Background Research needs to be reported transparently so readers can critically assess the strengths and weaknesses of the design, conduct, and analysis of studies. Reporting guidelines have been developed to inform reporting for a variety of study designs. The objective of this study was to identify whether there is a need to develop a reporting guideline for survey research. Methods and Findings We conducted a three-part project: (1) a systematic review of the literature (including “Instructions to Authors” from the top five journals of 33 medical specialties and top 15 general and internal medicine journals) to identify guidance for reporting survey research; (2) a systematic review of evidence on the quality of reporting of surveys; and (3) a review of reporting of key quality criteria for survey research in 117 recently published reports of self-administered surveys. Fewer than 7% of medical journals (n = 165) provided guidance to authors on survey research despite a majority having published survey-based studies in recent years. We identified four published checklists for conducting or reporting survey research, none of which were validated. We identified eight previous reviews of survey reporting quality, which focused on issues of non-response and accessibility of questionnaires. Our own review of 117 published survey studies revealed that many items were poorly reported: few studies provided the survey or core questions (35%), reported the validity or reliability of the instrument (19%), defined the response rate (25%), discussed the representativeness of the sample (11%), or identified how missing data were handled (11%). Conclusions There is limited guidance and no consensus regarding the optimal reporting of survey research. The majority of key reporting criteria are poorly reported in peer-reviewed survey research articles. Our findings highlight the need for clear and consistent reporting guidelines specific to survey research. Please see later in the article for the Editors' Summary, Editors' Summary Background Surveys, or questionnaires, are an essential component of many types of research, including health, and usually gather information by asking a sample of people questions on a specific topic and then generalizing the results to a larger population. Surveys are especially important when addressing topics that are difficult to assess using other approaches and usually rely on self reporting, for example self-reported behaviors, such as eating habits, satisfaction, beliefs, knowledge, attitudes, opinions. However, the methods used in conducting survey research can significantly affect the reliability, validity, and generalizability of study results, and without clear reporting of the methods used in surveys, it is difficult or impossible to assess these characteristics and therefore to have confidence in the findings. Why Was This Study Done? This uncertainty in other forms of research has given rise to Reporting Guidelines—evidence-based, validated tools that aim to improve the reporting quality of health research. The STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) Statement includes cross-sectional studies, which often involve surveys. But not all surveys are epidemiological, and STROBE does not include methods' and results' reporting characteristics that are unique to surveys. Therefore, the researchers conducted this study to help determine whether there is a need for a reporting guideline for health survey research. What Did the Researchers Do and Find? The researchers identified any previous relevant guidance for survey research, and any evidence on the quality of reporting of survey research, by: reviewing current guidance for reporting survey research in the “Instructions to Authors” of leading medical journals and in published literature; conducting a systematic review of evidence on the quality of reporting of surveys; identifying key quality criteria for the conduct of survey research; and finally, reviewing how these criteria are currently reported by conducting a review of recently published reports of self-administered surveys. The researchers found that 154 of the 165 journals searched (93.3%) did not provide any guidance on survey reporting, even though the majority (81.8%) have published survey research. Only three of the 11 journals that provided some guidance gave more than one directive or statement. Five papers and one Internet site provided guidance on the reporting of survey research, but none used validated measures or explicit methods for development. The researchers identified eight papers that addressed the quality of reporting of some aspect of survey research: the reporting of response rates; the reporting of non-response analyses in survey research; and the degree to which authors make their survey instrument available to readers. In their review of 117 published survey studies, the researchers found that many items were poorly reported: few studies provided the survey or core questions (35%), reported the validity or reliability of the instrument (19%), discussed the representativeness of the sample (11%), or identified how missing data were handled (11%). Furthermore, (88 [75%]) did not include any information on consent procedures for research participants, and one-third (40 [34%]) of papers did not report whether the study had received research ethics board review. What Do These Findings Mean? Overall, these results show that guidance is limited and consensus lacking about the optimal reporting of survey research, and they highlight the need for a well-developed reporting guideline specifically for survey research—possibly an extension of the guideline for observational studies in epidemiology (STROBE)—that will provide the structure to ensure more complete reporting and allow clearer review and interpretation of the results from surveys. Additional Information Please access these web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001069. More than 100 reporting guidelines covering a broad spectrum of research types are indexed on the EQUATOR Networks web site More information about STROBE is available on the STROBE Statement web site

Teachers and designers of computer-networked settings increasingly acknowledge that active learner engagement poses unique challenges, especially for instructors weaned on traditional site-based teaching, and that such engagement is essential to the progressive construction of learner knowledge. “Learner engagement” can mean several things: engagement with material, engagement with instructors, and, perhaps most important, peer engagement. Many teachers of computer-networked courses, who are quite diligent about incorporating activities and procedures to promote human interactivity, are confronted with the challenge of assessing the efficacy of their efforts. How do they discern whether the strategies and tactics woven into their “e-settings” are achieving the desired ends? This chapter outlines issues of self-assessment, including ethical questions. It lays out recommendations for self-assessment in a manner that respects student trust and confidentiality, distinguishing the demands of practical self-assessment from scholarly course research. The institutional pressures from which such assessment emerges are also examined.

The Preparation for Decision Making (PrepDM) scale was developed to evaluate decision processes relating to the preparation of patients for decision making and dialoguing with their practitioners. The objective of this study was to evaluate the scale's psychometric properties.From July 2005 to March 2006, after viewing a decision aid prescribed during routine clinical care, patients completed a questionnaire including: demographic information, treatment intention, decisional conflict, decision aid acceptability, and the PrepDM scale.Four hundred orthopaedic patients completed the questionnaire. The PrepDM scale showed significant correlation with the informed (r=-0.21, p0.01) and support (r=-0.13, p=0.01) subscales (DCS); and discriminated significantly between patients who did and did not find the decision aid helpful (p0.0001). Alpha coefficients for internal consistency ranged from 0.92 to 0.96. The scale is strongly unidimensional (principal components analysis) and Item Response Theory analyses demonstrated that all ten scale items function very well.The psychometric properties of the PrepDM scale are very good.The scale could allow more comprehensive evaluation of interventions designed to prepare patients for shared-decision making encounters regarding complex health care decisions.

Although cancer management is becoming more structured with disease-specific guidelines and clinical pathways, many decisions remain complex. Contributing to this complexity is the need to make value tradeoffs between benefits and harms across cancer treatment and/or screening options. Since there is no "best" option for everyone, decisions are defined as being of higher quality when informed with the latest scientific evidence and based on patients' informed values associated with outcomes of options. However, clinicians are not good judges of patients' values, and patients often have inadequate knowledge, unrealistic expectations, and decisional conflict that interfere with their involvement in decision making. Effective approaches to support patient involvement into clinical decisions include clinicians trained in shared decision making, question prompt sheets, patient decision aids, and decision coaching by nurses and other allied health professionals. Based on systematic review of 23 randomized trials of cancer patient decision aids, patients exposed to decision aids are more likely to participate in decision making and achieve higher-quality decisions. This review highlights key historical changes leading to patient involvement in decision making, summarizes evidence on effective interventions to support shared decision making, explores strategies to implement these interventions in oncology practices, and identifies future directions.

Objective: This study was performed to quantify adherence rates to lipid-lowering drug therapy among members of the Canadian Forces (CF) and to identify factors associated with nonadherence. Methods: Pharmacy claims were reviewed for all CF members who received a lipid-lowering drug between April 1 and June 1, 2003. Subjects were categorized as adherent if records indicated consumption of at least 80% of prescribed doses. Logistic regression was performed to assess the impact of patient and drug characteristics upon adherence. Results: Overall adherence rate at 1 year was 38.5% among all users of lipid-lowering medications. Adherence did not vary among the different classes of lipid-lowering drugs. Duration of service was the only independent predictor of adherence. Conclusions: Despite a relative lack of treatment barriers and the presence of established treatment programs in the CF health care system, long-term adherence with lipid-lowering medications remains suboptimal in this population.

Objective To characterize the use of personal stories in publicly available patient decision aids (PtDAs). Methods Descriptive study guided by a structured coding taxonomy based on the International Patient Decision Aid Standards, Ottawa Decision Support Framework, Decisional Conflict Scale and qualitative content analysis. Personal story was defined as an illustrative, first-person narrative in any format. Sampling from the 2007 Cochrane A to Z Inventory was stratified by developer and one-third of PtDAs were randomly sampled. Results Of 200 publicly available PtDAs from 5 developers, 168 from 3 developers contained stories. A stratified sample of 56 PtDAs contained 260 stories. Thirty of 56 PtDAs presented an equal number of stories favouring or against the most intensive option. Thirty PtDAs described narrators’ satisfaction with outcome(s): 21 contained only stories portraying satisfaction; 9 contained stories portraying satisfaction and dissatisfaction. Conclusion Publicly available PtDAs vary in their use of stories. Most PtDAs balance the number of stories favouring and against the most intensive option presented; most PtDAs do not balance the number of stories portraying satisfaction or dissatisfaction with the outcome(s) of the decision. Practice implications Research is needed to better understand the impact of stories on patient decision making and to inform the guidelines for their inclusion in PtDAs.

Objective To determine if people could find patient decision aids (PtDAs) on the Internet using the most popular general search engines. Methods We chose five medical conditions for which English language PtDAs were available from at least three different developers. The search engines used were: Google ( www.google.com ), Yahoo! ( www.yahoo.com ), and MSN ( www.msn.com ). For each condition and search engine we ran six searches using a combination of search terms. We coded all non-sponsored Web pages that were linked from the first page of the search results. Results Most first page results linked to informational Web pages about the condition, only 16% linked to PtDAs. PtDAs were more readily found for the breast cancer surgery decision (our searches found seven of the nine developers). The searches using Yahoo and Google search engines were more likely to find PtDAs. The following combination of search terms: condition , treatment , decision (e.g. breast cancer surgery decision) was most successful across all search engines (29%). Conclusion While some terms and search engines were more successful, few resulted in direct links to PtDAs. Practice implications Finding PtDAs would be improved with use of standardized labelling, providing patients with specific Web site addresses or access to an independent PtDA clearinghouse.

Objective. To describe the extent to which patient decision aids (PtDAs) meet effectiveness standards of the International Patient Decision Aids Collaboration (IPDAS). Data sources. Five electronic databases (to July 2006) and personal contacts (to December 2006). Results. Among 55 randomized controlled trials, 38 (69%) used at least 1 measure that mapped onto an IPDAS effectiveness criterion. Measures of decision quality were knowledge scores (27 trials), accurate risk perceptions (12 trials), and value congruence with the chosen option (3 trials). PtDAs improved knowledge scores relative to usual care (weighted mean difference [WMD] = 15.2%, 95% confidence interval [CI] = 11.7 to 18.7); detailed PtDAs were somewhat more effective than simpler PtDAs (WMD = 4.6%, 95% CI = 3.0 to 6.2). PtDAs with probabilities improved accurate risk perceptions relative to those without probabilities (relative risk = 1.6, 95% CI = 1.4 to 1.9). Relative to simpler PtDAs, detailed PtDAs improved value congruence with the chosen option. Only 2 of 6 IPDAS decision process criteria were measured: feeling informed (15 trials) and feeling clear about values (13 trials). PtDAs improved these process measures relative to usual care (feeling uninformed WMD = —8.4, 95% CI = —11.9 to —4.8; unclear values WMD = —6.3, 95% CI = —10.0 to —2.7). There was no difference in process measures when detailed and simple PtDAs were compared. Conclusions. PtDAs improve decision quality and the decision process's measures of feeling informed and clear about values; however, the size of the effect varies across studies. Several IPDAS decision process measures have not been used. Future trials need to use a minimum data set of IPDAS evaluation measures. The degree of detail PtDAs require for positive effects on IPDAS criteria should be explored.

Background Decision aids are evidence based tools that assist patients in making informed values-based choices and supplement the patient-clinician interaction. While there is evidence to show that decision aids improve key indicators of patients' decision quality, relatively little is known about physicians' acceptance of decision aids or factors that influence their decision to use them. The purpose of this study was to describe physicians' perceptions of three decision aids, their expressed intent to use them, and their subsequent use of them. Methods We conducted a cross-sectional survey of random samples of Canadian respirologists, family physicians, and geriatricians. Three decision aids representing a range of health decisions were evaluated. The survey elicited physicians' opinions on the characteristics of the decision aid and their willingness to use it. Physicians who indicated a strong likelihood of using the decision aid were contacted three months later regarding their actual use of the decision aid. Results Of the 580 eligible physicians, 47% (n = 270) returned completed questionnaires. More than 85% of the respondents felt the decision aid was well developed and that it presented the essential information for decision making in an understandable, balanced, and unbiased manner. A majority of respondents (>80%) also felt that the decision aid would guide patients in a logical way, preparing them to participate in decision making and to reach a decision. Fewer physicians ( Conclusion Despite strong support for the format, content, and quality of patient decision aids, and physicians' stated intentions to adopt them into clinical practice, most did not use them within three months of completing the survey. There is a wide gap between intention and behaviour. Further research is required to study the determinants of this intention-behaviour gap and to develop interventions aimed at barriers to physicians' use of decision aids.

Background There is considerable unexplained heterogeneity in previous meta-analyses of randomized controlled trials (RCTs) evaluating the effects of patient decision aids on the accuracy of knowledge of outcome probabilities. The purpose of this review was to explore possible effect modification by three covariates: the type of control intervention, decision aid quality and patients' baseline knowledge of probabilities. Methods A sub-analysis of studies previously identified in the 2011 Cochrane review on decision aids for people facing treatment and screening decisions was conducted. Additional unpublished data were requested from relevant study authors to maximize the number of eligible studies. RCTs (to 2009) comparing decision aids with standardized probability information to control interventions (lacking such information) and assessing the accuracy of patient knowledge of outcome probabilities were included. The proportions of patients with accurate knowledge of outcome probabilities in each group were converted into relative effect measures. Intervention quality was assessed using the International Patient Decision Aid Standards instrument (IPDASi) probabilities domain. Results A main effects analysis of 17 eligible studies confirmed that decision aids significantly improve the accuracy of patient knowledge of outcome probabilities (relative risk = 1.80 [1.51, 2.16]), with considerable heterogeneity (87%). The type of control did not modify effects. Meta-regression suggested that the IPDASi probabilities domain score (reflecting decision aid quality) is a potential effect modifier (P = 0.037), accounting for a quarter of the variability (R2 = 0.28). Meta-regression indicated the control event rate (reflecting baseline knowledge) is a significant effect modifier (P = 0.001), with over half the variability in ln(OR) explained by the linear relationship with log-odds for the control group (R2 = 0.52); this relationship was slightly strengthened after correcting for the statistical dependence of the effect measure on the control event rate. Conclusions Patients’ baseline level of knowledge of outcome probabilities is an important variable that explains the heterogeneity of effects of decision aids on improving accuracy of this knowledge. Greater relative effects are observed when the baseline proportion of patients with accurate knowledge is lower. This may indicate that decision aids are more effective in populations with lower knowledge.

Background Health administrative data is increasingly being used for chronic disease surveillance. This study explored agreement between administrative and survey data for ascertainment of seven key chronic diseases, using individually linked data from a large population of individuals in Ontario, Canada. Methods All adults who completed any one of three cycles of the Canadian Community Health Survey (2001, 2003 or 2005) and agreed to have their responses linked to provincial health administrative data were included. The sample population included 85,549 persons. Previously validated case definitions for myocardial infarction, asthma, diabetes, chronic lung disease, stroke, hypertension and congestive heart failure based on hospital and physician billing codes were used to identify cases in health administrative data and these were compared with self-report of each disease from the survey. Concordance was measured using the Kappa statistic, percent positive and negative agreement and prevalence estimates. Results Agreement using the Kappa statistic was good or very good (kappa range: 0.66-0.80) for diabetes and hypertension, moderate for myocardial infarction and asthma and poor or fair (kappa range: 0.29-0.36) for stroke, congestive heart failure and COPD. Prevalence was higher in health administrative data for all diseases except stroke and myocardial infarction. Health Utilities Index scores were higher for cases identified by health administrative data compared with self-reported data for some chronic diseases (acute myocardial infarction, stroke, heart failure), suggesting that administrative data may pick up less severe cases. Conclusions In the general population, discordance between self-report and administrative data was large for many chronic diseases, particularly disease with low prevalence, and differences were not easily explained by individual and disease characteristics.

Background. Decision coaching is individualized, nondirective facilitation of patient preparation for shared decision making. Purpose. To explore characteristics and effectiveness of decision coaching evaluated within trials of patient decision aids (PtDAs) for health decisions. Data Sources. A subanalysis of trials included in the 2011 Cochrane Review of PtDAs. Study Selection. Eligible trials allowed the effectiveness of decision coaching to be compared with another intervention and/or usual care. Data Extraction. Two reviewers independently screened 86 trials, extracted data, and appraised quality. Data Synthesis. Ten trials were eligible. Decision coaching was provided by genetic counselors, nurses, pharmacists, physicians, psychologists, or health educators. Coaching compared with usual care ( n = 1 trial) improved knowledge. Coaching plus PtDA compared with usual care ( n = 4) improved knowledge and participation in decision making without reported dissatisfaction. Coaching compared with PtDA alone ( n = 4) increased values-choice agreement and improved satisfaction with the decision-making process without any difference in knowledge or participation in decision making. Coaching plus PtDA compared with PtDA alone ( n = 4) had no difference in knowledge, values-choice agreement, participation in decision making, or satisfaction with the process. Decision coaching plus PtDA was more cost-effective compared with PtDA alone or usual care ( n = 1). Limitations. Methodological quality, number of trials, and description of decision coaching. Conclusions. Compared with usual care, decision coaching improved knowledge. However, the improvement in knowledge was similar when coaching was compared with PtDA alone. Outcomes for other comparisons are more variable, some trials showing positive effects and other trials reporting no difference. Given the small number of trials and variability in results, further research is required to determine the effectiveness of decision coaching.

Bone scintigraphy was performed for staging in a patient with prostate carcinoma. Physical examination revealed an enlarged scrotum and inguinal hernia. The bone scintigrams demonstrated wide-spread bony metastases, as well as dense accumulation of activity in the scrotum that appeared contiguous with the urinary bladder. A radiocontrast cystogram confirmed herniation of the urinary bladder into the scrotum.

The distribution of somatostatin (SRIF) was examined in normal human forebrain, using thick vibratome cut sections. The unlabeled antibody enzyme method of immunocytochemistry revealed a widespread distribution of SRIF immunoreactive neurons and fibers throughout the septum, diencephalon and corpus striatum. Within the septum SRIF neurons and fibers were observed in the medial and lateral septal nuclei, the nucleus of the diagonal band, the nucleus accumbens and the bed nucleus of the stria terminalis. SRIF neurons and fibers were found in several hypothalamic and anterior thalamic nuclei as well as all regions of the corpus striatum. An interesting collection of SRIF immunoreactive neurons and processes were observed forming a wide band extending anteriorly from the lateral preoptic area through the lateral hypothalamus and substantia innominata posteriorly. This report on the localization of immunoreactive SRIF in the human forebrain extends previous anatomical findings and lends morphological support to recent biochemical studies.

The distribution of somatostatin (SRIF) was examined using the unlabeled antibody enzyme method of immunocytochemistry on thick 30–50 μm Vibratome sections. The greatest population of SRIF-neurons was observed along the vertricular wall in the preoptic area and anterior hypothalamus. Dense accumulations of fibers were observed in the suprachiasmatic, ventromedial and arcuate nuclei, the internal and external zone of the median eminence, the organum vasculosum of the lamina terminalis and the subfornical organ. Extrahypothalamic sites of SRIF-containing neurons and fibers were also observed throughout the telencephalon. The widespread distribution of SRIF is consistent with radioimmunoassay data and suggest a diverse physiological role for somatostatin.

Immunocytochemical localization of ACTH-opiocortin perikarya was demonstrated in the medulla of colchicine-treated rat. Neuronal cell bodies and fibers containing ACTH-immunoreactivity were abundant in the caudal region of the nucleus tractus solitarius, specifically within pars commisuralis. Location of these opiocortin neurons within the nucleus tractus solitarius provides additional evidence for a role of these peptides in cardiovascular functions.

Immunocytochemical analysis using antisera generated against the brain peptide somatostatin (SRIF) was examined in the brain of normal mice and in mice with chemical lesions of the arcuate nucleus produced neonatally by the administration of monosodium glutamate (MSG). In the normal mouse brain, SRIF immunoreactivity was seen in perikarya of the preoptic and hypothalamic periventricular nuclei. The normal distribution of SRIF fibers was apparent in several hypothalamic nuclei including the arcuate nucleus and in the internal and external zones of the median eminence. Extrahypothalamic sites of SRIF immunoreactive neurons and fibers were also observed throughout the telencephalon. At 60 days of age, certain neuroendocrine deficiencies, including growth parameters and obesity, were apparent in MSG-treated newborn mice. Analysis of SRIF projections in the brain of MSG-treated mice demonstrated a neurotoxic effect on arcuate neurons and a loss of SRIF projections to this region as well. Other components of the SRIF system in brain appeared unaffected. SRIF fibers of the arcuate region seem to originate from neuronal perikarya of the periventricular nucleus suggesting that MSG-induced endocrine deficiencies may be due to SRIF interactions at the level of the arcuate nucleus.

The distribution of luteinizing hormone-releasing hormone (LHRH)-immunoreactive perikarya and processes was examined, in the untreated rat, with the unlabeled antibody enzyme method of immunocytochemistry on thick 50 micron vibratome sections. LHRH neurons were primarily observed in the preoptico-anterior hypothalamic and septal areas. Projections from these cell bodies to the median eminence form three distinct pathways, one laterally along the course of the optic tracts, one medially through the periventricular stratum of the third ventricle, and one through the tractus infundibularis. In addition, some of these cell bodies project to the organum vasculosum of the lamina terminalis (OVLT) and the subfornical organ (SFO). LHRH immunoreactive neurons were also noted in the anterior olfactory regions; they project along the medial olfactory tract to the olfactory bulb.

Background Prevention efforts are informed by the numbers of deaths or cases of disease caused by specific risk factors, but these are challenging to estimate in a population. Fortunately, an increasing number of jurisdictions have increasingly rich individual-level, population-based data linking exposures and outcomes. These linkages enable multivariable approaches to risk assessment. We demonstrate how this approach can estimate the population burden of risk factors and illustrate its advantages over often-used population-attributable fraction methods. Methods We obtained risk factor information for 78,597 individuals from a series of population-based health surveys. Each respondent was linked to death registry (568,997 person-years of follow-up, 6,399 deaths).Two methods were used to obtain population-attributable fractions. First, the mortality rate difference between the entire population and the population of non-smokers was divided by the total mortality rate. Second, often-used attributable fraction formulas were used to combine summary measures of smoking prevalence with relative risks of death for select diseases. The respective fractions were then multiplied to summary measures of mortality to obtain smoking-attributable mortality. Alternatively, for our multivariable approach, we created algorithms for risk of death, predicted by health behaviors and various covariates (age, sex, socioeconomic position, etc.). The burden of smoking was determined by comparing the predicted mortality of the current population with that of a counterfactual population where smoking is eliminated. Results Our multivariable algorithms accurately predicted an individual’s risk of death based on their health behaviors and other variables in the models. These algorithms estimated that 23.7% of all deaths can be attributed to smoking in Ontario. This is higher than the 20.0% estimated using population-attributable risk methods that considered only select diseases and lower than the 35.4% estimated from population-attributable risk methods that examine the excess burden of all deaths due to smoking. Conclusions The multivariable algorithms presented have several advantages, including: controlling for confounders, accounting for complexities in the relationship between multiple exposures and covariates, using consistent definitions of exposure, and using specific measures of risk derived internally from the study population. We propose the wider use of multivariable risk assessment approach as an alternative to population-attributable fraction methods.

Background Modelling studies are used widely to help inform decisions about health care and policy and their use is increasing. However, in order for modelling to gain strength as a tool for health policy, it is critical that key model factors are transparent so that users of models can have a clear understanding of the model and its limitations.Reporting guidelines are evidence-based tools that specify minimum criteria for authors to report their research such that readers can both critically appraise and interpret study findings. This study was conducted to determine whether there is an unmet need for population modelling reporting guidelines. Methods We conducted a review of the literature to identify: 1) guidance for reporting population modelling studies; and, 2) evidence on the quality of reporting of population modelling studies. Guidance for reporting was analysed using a thematic approach and the data was summarised as frequencies. Evidence on the quality of reporting was reviewed and summarized descriptively. Results There were no guidelines that specifically addressed the reporting of population modelling studies. We identified a number of reporting guidelines for economic evaluation studies, some of which had sections that were relevant population modelling studies. Amongst seven relevant records, we identified 69 quality criteria that have distinct reporting characteristics. We identified two papers that addressed reporting practices of modelling studies. Overall, with the exception of describing the data used for calibration, there was little consistency in reporting. Conclusions While numerous guidelines exist for developing and evaluating health technology assessment and economic evaluation models, which by extension could be applicable to population modelling studies, there is variation in their comprehensiveness and in the consistency of reporting these methods. Population modelling studies may be an area which would benefit from the development of a reporting guideline.

Background Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs. Methods Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers. Results Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to the type of intervention under study in a CRT. Informants rarely expressed concern regarding risks to research participants in CRTs, other than risks to privacy. Important issues identified in the research ethics literature, including fair subject selection and other justice issues, were not mentioned by informants. The ethics review process has had positive and negative impacts on CRT conduct. Informants stated that variability in ethics review between jurisdictions, and increasingly stringent ethics review in recent years, have hampered their ability to conduct CRTs. Many informants said that comprehensive ethics guidelines for CRTs would be helpful to researchers and research ethics committees. Conclusions Informants identified key ethical challenges in the conduct of CRTs, specifically relating to identifying subjects, seeking informed consent, and the use of gatekeepers. These data have since been used to identify topics for in-depth ethical analysis and to guide the development of comprehensive ethics guidelines for CRTs.