Tympanic membrane perforations cannot be reliably detected using computed tomography based on 15 cadaver dogs.

The integrity of the tympanic membrane is an important factor when deciding treatment and therapeutic recommendations for dogs with ear disease; however, otoscopic examination may be difficult to perform due to features of external ear canal disease or patient compliance. CT is useful for the evaluation of middle ear disease, including cases in which middle ear disease is detected incidentally. The tympanic membrane is detectable using CT, but anecdotally, apparent focal defects or discontinuities of the tympanic membrane are often seen in patients with and without ear disease. The purpose of this prospective, observer agreement study was to determine if perforations of the tympanic membrane are reliably detectable on CT. Fifteen cadaver dogs underwent CT and video otoscopy to verify the integrity of each tympanic membrane. Cadavers were randomly assigned to have the tympanic membranes left intact or to undergo a myringotomy on either the left, the right, or both sides. CT was performed immediately following the myringotomies. Four blinded evaluators evaluated the pre- and post-myringotomy scans for a total of 30 scans (60 tympanic membranes). Average accuracy was low (44%), and interobserver agreement for all four evaluators was fair. Although the tympanic membrane is visible on CT, perforations of the tympanic membrane are unlikely to be accurately detected or excluded. The appearance of an intact tympanic membrane or defect in the membrane on CT should not be used as criteria to guide clinical treatment recommendations based on this cadaver model.

Prevalence of Demodex gatoi in shelter and feral cats in a southeastern region of the United States.

BACKGROUND: Demodex gatoi is a contagious ectoparasite that causes pruritic dermatitis in otherwise healthy cats. The diagnosis of this mite can be difficult, and its prevalence is unknown. OBJECTIVES: The goal of this study was to identify the prevalence of D. gatoi in a population of cats with no known previous exposure to treatments using real-time PCR and superficial skin scrapings. ANIMALS: Fifty cats from shelters and 50 cats from feral populations of eastern Tennessee were included in this study. MATERIALS AND METHODS: To identify the presence of D. gatoi, superficial skin scrapings and plucked hairs were collected from multiple sites for microscopic and PCR evaluation, respectively. RESULTS: Ten of 100 cats were positive for D. gatoi. Nine cats had a positive PCR for D. gatoi with negative skin scrapings. One mite was identified on superficial skin scrapings from one cat, which was negative on PCR. Four of 50 feral cats (8%) were positive for D. gatoi. Of the shelter cats, four of 20 stray cats (20%) and two of 30 owner-surrendered cats (6.67%) were positive. Only one of 10 positive cats had skin lesions. CONCLUSIONS AND CLINICAL RELEVANCE: These findings demonstrate that asymptomatic cats represent a source of infection for D. gatoi to healthy cats. This mite should be considered a differential diagnosis in pruritic cats with a history of potential exposure. Additionally, skin scrapings appear to be insensitive; thus, multiple diagnostic tests, including PCR, should be performed to identify the presence of D. gatoi.

Effect of topical florfenicol, terbinafine and mometasone furoate ear drops on adrenocortical function in healthy small breed dogs with bilateral otitis externa.

BACKGROUND: Testing for hyperadrenocorticism is commonly pursued in adult dogs with dermatological disease, and adrenocortical suppression has been well-documented following the use of topical corticosteroids in otic preparations. An otic suspension that contains florfenicol, terbinafine and mometasone furoate, and lasts for 30 days after a single application, frequently is used to treat canine otitis externa (OE). This medication was shown to cause adrenocortical suppression on Day (D)2 postadministration and two weeks after two applications two weeks apart. HYPOTHESIS/OBJECTIVES: The objective of this study was to determine if topical florfenicol/terbinafine/mometasone furoate causes adrenocortical suppression in healthy, small-breed dogs with bilateral OE at D28 postapplication. ANIMAL: Seven client-owned dogs weighing <10 kg diagnosed with non-Pseudomonas bilateral OE. MATERIALS AND METHODS: Cortisol was measured pre- and post-adrenocorticotropic (ACTH) stimulation on D0. Topical florfenicol/terbinafine/mometasone furoate was applied in both ears. Dogs were reassessed on D28, and cortisol was measured pre- and post-ACTH stimulation. RESULTS: The median pre- and post-ACTH cortisol concentrations on D28 were 2.5 µg/dL (range 2.0-5.0 µg/dL) and 14.3 µg/dL (range 11.5-23.1 µg/dL), respectively. There was no significant difference (P = 0.85) between post-ACTH cortisol concentrations from D0 to D28. CONCLUSIONS AND CLINICAL RELEVANCE: Results demonstrated no evidence of adrenocortical suppression, suggesting that there is no need to delay adrenocortical function testing in dogs treated with topical florfenicol/terbinafine/mometasone furoate when applied as per the manufacturer's recommendations.

Multidisciplinary In Situ Simulation-Based Training as a Postpartum Hemorrhage Quality Improvement Project.

BACKGROUND: Postpartum hemorrhage is a common obstetric emergency affecting 3 to 5% of deliveries, with significant maternal morbidity and mortality. Effective management of postpartum hemorrhage requires strong teamwork and collaboration. We completed a multidisciplinary in situ postpartum hemorrhage simulation training exercise with structured team debriefing to evaluate hospital protocols, team performance, operational readiness, and real-time identification of system improvements. Our objective was to assess participant comfort with managing obstetric hemorrhage following our multidisciplinary in situ simulation training exercise. METHODS: This was a quality improvement project that utilized a comprehensive multidisciplinary in situ postpartum hemorrhage simulation exercise. Participants from the Departments of Obstetrics and Gynecology, Anesthesia, Nursing, Pediatrics, and Transfusion Services completed the training exercise in 16 scenarios run over 2 days. The intervention was a high fidelity, multidisciplinary in situ simulation training to evaluate hospital protocols, team performance, operational readiness, and system improvements. Structured debriefing was conducted with the participants to discuss communication and team functioning. Our main outcome measure was participant self-reported comfort levels for managing postpartum hemorrhage before and after simulation training. A 5-point Likert scale (1 being very uncomfortable and 5 being very comfortable) was used to measure participant comfort. A paired t test was used to assess differences in participant responses before and after the simulation exercise. We also measured the time to prepare simulated blood products and followed the number of postpartum hemorrhage cases before and after the simulation exercise. RESULTS: We trained 113 health care professionals including obstetricians, midwives, residents, anesthesiologists, nurse anesthetists, nurses, and medical assistants. Participants reported a higher comfort level in managing obstetric emergencies and postpartum hemorrhage after simulation training compared to before training. For managing hypertensive emergencies, the post-training mean score was 4.14 compared to a pretraining mean score of 3.88 (p = 0.01, 95% confidence interval [CI] = 0.06-0.47). For shoulder dystocia, the post-training mean score was 4.29 compared to a pretraining mean score of 3.66 (p = 0.001, 95% CI = 0.41-0.88). For postpartum hemorrhage, the post-training mean score was 4.35 compared to pretraining mean score of 3.86 (p = 0.001, 95% CI = 0.36-0.63). We also observed a decrease in the time to prepare simulated blood products over the course of the simulation, and a decreasing trend of postpartum hemorrhage cases, which continued after initiating the postpartum hemorrhage simulation exercise. DISCUSSION: Postpartum hemorrhage remains a leading cause of maternal morbidity and mortality in the United States. Comprehensive hemorrhage protocols have been shown to improve outcomes related to postpartum hemorrhage, and a critical component in these processes include communication, teamwork, and team-based practice/simulation. As medicine becomes increasingly complex, the ability to practice in a safe setting is ever more critical, especially for low-volume, high-stakes events such as postpartum hemorrhage. These events require well-functioning teams and systems coupled with rapid assessment and appropriate clinical action to ensure best patient outcomes. We have shown that a multidisciplinary in situ simulation exercise improves self-reported comfort with managing obstetric emergencies, and is a safe and effective way to practice skills and improve systems processes in the health care setting.

Health services and policy research in the first decade at the Canadian Institutes of Health Research.

BACKGROUND: Health services and policy research is the innovation engine of a health care system. In 2000, the Canadian Institutes of Health Research (CIHR) was formed to foster the growth of all sciences that could improve health care. We evaluated trends in health services and policy research funding, in addition to determinants of funding success. METHODS: All applications submitted to CIHR strategic and open operating grant competitions between 2001 and 2011 were included in our analysis. Age, sex, size of research team, critical mass, season, year and research discipline were retrieved from application information. A cohort of 4725 applicants successfully funded between 2001 and 2005 were followed for 5 years to evaluate predictors of continuous funding. Multivariate generalized estimating equation logistic regression was used to estimate predictors of funding success and sustained funding. RESULTS: Between 2001 and 2011, 80 163 applications were submitted to open and strategic grant competitions. Over time, grant applications increased from 327 to 1137 per year, and annual funding increased from $12.6 to $48.0 million. Grant applications from young male researchers were more likely to be funded than those from female researchers (odds ratio [OR] 1.40, 95% confidence interval [CI] 1.01-1.95), as were applications from larger research teams and institutions with a large critical mass. Only 24.0% of scientists whose first funded grant was in health services and policy research had sustained 5-year funding, compared with 52.8% of biomedical scientists (OR 0.34, 95% CI 0.24-0.49). INTERPRETATION: The CIHR has successfully increased the amount of health services and policy research in Canada. To enhance conditions for success, researchers should be encouraged to work in teams, request longer duration grants, resubmit unsuccessful applications and affiliate themselves with institutions with a greater critical mass.

Assessment of procedural skills training and performance in anesthesia using cumulative sum analysis (cusum).

PURPOSE: The current methods (work based assessments and logbooks) used to assess procedural competency and performance have well-documented deficiencies. Cumulative sum analysis (cusum), a statistical method that generates performance graphs over time, is an alternative tool that is not currently widely used. The purpose of this review is to investigate its current role in anesthetic procedural skills training and performance. SOURCE: A literature search of MEDLINE(®), EMBASE™, BNI, CINAHL(®), the Cochrane Library, NHS Evidence, and the Trip database was performed in October 2012. All papers using cusum to investigate performance in anesthetic procedural skills were included. Their references were searched manually to identify any additional studies. PRINCIPAL FINDINGS: Thirteen papers were identified. The procedural skills they investigated could be split broadly into three groups: ultrasound skills, airway and cannulation, and regional anesthesia. All papers had small sample sizes (< 30), with most researching novice trainee performance. Wide ranges were seen in the number of procedures required to achieve cusum-defined procedural competency. These were due to differences in definitions of success/failure of a procedure, the acceptable and unacceptable failure rates used for the initial cusum calculation, and individual trainee performance. CONCLUSION: Cusum can be used to assess procedural competency, but several problems need to be overcome before it can become a universally accepted method. It is ideally placed to be used as a quality control tool for a trained individual and could also be used to assess the impact of new training methods or equipment on performance.

Bulbar muscle weakness and fatty lingual infiltration in glycogen storage disorder type IIIa.

Glycogen storage disorder type III (GSD III) is a rare autosomal recessive disorder resulting from a deficiency of glycogen debranching enzyme, critical in cytosolic glycogen degradation. GSD IIIa, the most common form of GSD III, primarily affects the liver, cardiac muscle, and skeletal muscle. Although skeletal muscle weakness occurs commonly in GSD IIIa, bulbar muscle involvement has not been previously reported. Here we present three GSD IIIa patients with clinical evidence of bulbar weakness based on instrumental assessment of lingual strength. Dysarthria and/or dysphagia, generally mild in severity, were evident in all three individuals. One patient also underwent correlative magnetic resonance imaging (MRI) which was remarkable for fatty infiltration at the base of the intrinsic tongue musculature, as well as abnormal expansion of the fibro-fatty lingual septum. Additionally, we provide supportive evidence of diffuse glycogen infiltration of the tongue at necropsy in a naturally occurring canine model of GSD IIIa. While further investigation in a larger group of patients with GSD III is needed to determine the incidence of bulbar muscle involvement in this condition and whether it occurs in GSD IIIb, clinical surveillance of lingual strength is recommended.

Long-term efficacy following readministration of an adeno-associated virus vector in dogs with glycogen storage disease type Ia.

Glycogen storage disease type Ia (GSD-Ia) is the inherited deficiency of glucose-6-phosphatase (G6Pase), primarily found in liver and kidney, which causes life-threatening hypoglycemia. Dogs with GSD-Ia were treated with double-stranded adeno-associated virus (AAV) vectors encoding human G6Pase. Administration of an AAV9 pseudotyped (AAV2/9) vector to seven consecutive GSD-Ia neonates prevented hypoglycemia during fasting for up to 8 hr; however, efficacy eventually waned between 2 and 30 months of age, and readministration of a new pseudotype was eventually required to maintain control of hypoglycemia. Three of these dogs succumbed to acute hypoglycemia between 7 and 9 weeks of age; however, this demise could have been prevented by earlier readministration an AAV vector, as demonstrated by successful prevention of mortality of three dogs treated earlier in life. Over the course of this study, six out of nine dogs survived after readministration of an AAV vector. Of these, each dog required readministration on average every 9 months. However, two were not retreated until >34 months of age, while one with preexisting antibodies was re-treated three times in 10 months. Glycogen content was normalized in the liver following vector administration, and G6Pase activity was increased in the liver of vector-treated dogs in comparison with GSD-Ia dogs that received only with dietary treatment. G6Pase activity reached approximately 40% of normal in two female dogs following AAV2/9 vector administration. Elevated aspartate transaminase in absence of inflammation indicated that hepatocellular turnover in the liver might drive the loss of vector genomes. Survival was prolonged for up to 60 months in dogs treated by readministration, and all dogs treated by readministration continue to thrive despite the demonstrated risk for recurrent hypoglycemia and mortality from waning efficacy of the AAV2/9 vector. These preclinical data support the further translation of AAV vector-mediated gene therapy in GSD-Ia.

Highly specific off-target binding identified and eliminated during the humanization of an antibody against FGF receptor 4.

Off-target binding can significantly affect the pharmacokinetics (PK), tissue distribution, efficacy and toxicity of a therapeutic antibody. Herein we describe the development of a humanized anti- fibroblast growth factor receptor 4 (FGFR4) antibody as a potential therapeutic for hepatocellular carcinoma (HCC). A chimeric anti FGFR4 monoclonal antibody (chLD1) was previously shown to block ligand binding and to inhibit FGFR4 mediated signaling as well as tumor growth in vivo. A humanized version of chLD1, hLD1.vB, had similar binding affinity and in vitro blocking activity, but it exhibited rapid clearance, poor target tissue biodistribution and limited efficacy when compared to chLD1 in a HUH7 human HCC xenograft mouse model. These problems were traced to instability of the molecule in rodent serum. Size exclusion high performance liquid chromatography, immunoprecipitation and mass spectral sequencing identified a specific interaction between hLD1.vB and mouse complement component 3 (C3). A PK study in C3 knock-out mice further confirmed this specific interaction. Subsequently, an affinity-matured variant derived from hLD1.vB (hLD1.v22), specifically selected for its lack of binding to mouse C3 was demonstrated to have a PK profile and in vivo efficacy similar to that of chLD1 in mice. Although reports of non-specific off-target binding have been observed for other antibodies, this represents the first report identifying a specific off-target interaction that affected disposition and biological activity. Screens developed to identify general non-specific interactions are likely to miss the rare and highly specific cross-reactivity identified in this study, thus highlighting the importance of animal models as a proxy for avoiding unexpected clinical outcomes.

Assessing the quality of decision support technologies using the International Patient Decision Aid Standards instrument (IPDASi).

OBJECTIVES: To describe the development, validation and inter-rater reliability of an instrument to measure the quality of patient decision support technologies (decision aids). DESIGN: Scale development study, involving construct, item and scale development, validation and reliability testing. SETTING: There has been increasing use of decision support technologies--adjuncts to the discussions clinicians have with patients about difficult decisions. A global interest in developing these interventions exists among both for-profit and not-for-profit organisations. It is therefore essential to have internationally accepted standards to assess the quality of their development, process, content, potential bias and method of field testing and evaluation. METHODS: Scale development study, involving construct, item and scale development, validation and reliability testing. PARTICIPANTS: Twenty-five researcher-members of the International Patient Decision Aid Standards Collaboration worked together to develop the instrument (IPDASi). In the fourth Stage (reliability study), eight raters assessed thirty randomly selected decision support technologies. RESULTS: IPDASi measures quality in 10 dimensions, using 47 items, and provides an overall quality score (scaled from 0 to 100) for each intervention. Overall IPDASi scores ranged from 33 to 82 across the decision support technologies sampled (n = 30), enabling discrimination. The inter-rater intraclass correlation for the overall quality score was 0.80. Correlations of dimension scores with the overall score were all positive (0.31 to 0.68). Cronbach's alpha values for the 8 raters ranged from 0.72 to 0.93. Cronbach's alphas based on the dimension means ranged from 0.50 to 0.81, indicating that the dimensions, although well correlated, measure different aspects of decision support technology quality. A short version (19 items) was also developed that had very similar mean scores to IPDASi and high correlation between short score and overall score 0.87 (CI 0.79 to 0.92). CONCLUSIONS: This work demonstrates that IPDASi has the ability to assess the quality of decision support technologies. The existing IPDASi provides an assessment of the quality of a DST's components and will be used as a tool to provide formative advice to DSTs developers and summative assessments for those who want to compare their tools against an existing benchmark.

Can people find patient decision aids on the Internet?

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.

Audit and feedback using the brief Decision Support Analysis Tool (DSAT-10) to evaluate nurse-standardized patient encounters.

OBJECTIVE: To evaluate the brief Decision Support Analysis Tool (DSAT-10) for auditing the quality of nurse-standardized patient encounters, structuring feedback for nurses, and testing instrument reliability. METHODS: A systematic process was used to develop standardized patient scenarios, pilot-test scenarios, calibrate DSAT-10 coders, analyze taped telephone encounters using DSAT-10, and provide feedback. Inter-rater reliability was calculated using coder agreement, kappa, and intra-class correlation coefficients. RESULTS: Six scenarios portrayed patients' decisional uncertainty from either: pressure from others (n=2), unclear values (n=2), or inadequate information (n=2). Scenarios were easy to use over the telephone, produced realistic role performance, and were practical for audio-recording interactions. DSAT-10 analysis of 76 nurse-standardized patient encounters revealed nurses' strengths (e.g., information provision) and their limitations (e.g., lack of discussion of values and/or support needs). Scores discriminated between trained and untrained nurses. The kappa coefficient over all items was 0.55 (95% CI: 0.49, 0.61) with higher agreement for encounters involving trained nurses (0.62; 95% CI: 0.43, 0.80). CONCLUSION: Auditing nurse-standardized patient encounters using DSAT-10 and providing feedback to nurses was feasible. Although DSAT-10 items had adequate inter-rater reliability and discriminated between trained/untrained nurses, some items were problematic. PRACTICE IMPLICATIONS: Providing feedback on nurse encounters with standardized patients experiencing uncertainty has the potential to enhance nurses' decision support skills.

Brief review: anesthetic implications of long QT syndrome in pregnancy.

PURPOSE: To review the effects of the long QT syndrome (LQTS) in the parturient and the current anesthetic management of patients with LQTS. SOURCE: Relevant articles were obtained from a MEDLINE search spanning the years 1980-2006 and a PubMed search spanning the years 1949-2006. Bibliographies of retrieved articles were searched for additional articles. PRINCIPAL FINDINGS: The prevalence of LQTS in the developed world is one per 1,100 to 3,000 of the population. Clinically, LQTS is characterized by syncope, cardiac arrest and occasionally, by a history of seizures. The QT interval can also be prolonged by drugs, electrolyte imbalances, toxins and certain medical conditions. Long QT syndrome patients are at risk of torsades de pointes and ventricular fibrillation. Medical management aims to reduce dysrhythmia frequency. The LQTS is subdivided into different groups (LQT1-6) depending on the cardiac ion channel abnormality. Torsades can be precipitated by adrenergic stimuli such as stress or pain (LQT1 and 2), sudden noises (LQT2) or whilst sleeping (LQT3). Patients with LQTS require careful anesthetic management as they are at high risk of torsades perioperatively despite minimal data on the effects of anesthetic agents on the QT interval. While information on effects of LQTS in pregnancy is limited, the incidence of dysrhythmia increases postpartum. Isolated case reports of patients with LQTS women highlight several peripartum dysrhythmias. CONCLUSION: An understanding of LQTS and the associated risk factors contributing to dysrhythmias is important for anesthesthesiologists caring for parturients with LQTS.

Association between family history of prostate and breast cancer among African-American men with prostate cancer.

OBJECTIVES: To explore the familial aggregation of prostate and breast cancer using data from a population-based case-control study of African-American men participating in the Flint Men's Health Study. METHODS: A detailed family history questionnaire was administered to 121 African-American men with prostate cancer and 179 African-American male controls. The family history data of prostate and breast cancer in first-degree relatives were compared between men with and without prostate cancer using standard statistical methods. RESULTS: In the Flint Men's Health Study, men with prostate cancer were more likely than controls to report having a brother with prostate cancer (age-adjusted odds ratio 4.80, 95% confidence interval 2.01 to 11.44) or a sister with breast cancer (age-adjusted odds ratio 3.80, 95% confidence interval 1.57 to 9.22). CONCLUSIONS: Although a family history of prostate cancer is a recognized prostate cancer risk factor consistent across different races, few studies have examined the co-clustering of breast and prostate cancer within African-American families. Future studies should focus on racially heterogeneous populations to further explore the observation from the Flint Men's Health Study that having a brother with prostate cancer or a sister with breast cancer may be associated with prostate cancer occurrence. This research may have implications for both gene identification and early detection strategies.

Mutations in the Arabidopsis phosphoinositide phosphatase gene SAC9 lead to overaccumulation of PtdIns(4,5)P2 and constitutive expression of the stress-response pathway.

Phosphoinositides (PIs) are signaling molecules that regulate cellular events including vesicle targeting and interactions between membrane and cytoskeleton. Phosphatidylinositol (PtdIns)(4,5)P(2) is one of the best characterized PIs; studies in which PtdIns(4,5)P(2) localization or concentration is altered lead to defects in the actin cytoskeleton and exocytosis. PtdIns(4,5)P(2) and its derivative Ins(1,4,5)P(3) accumulate in salt, cold, and osmotically stressed plants. PtdIns(4,5)P(2) signaling is terminated through the action of inositol polyphosphate phosphatases and PI phosphatases including supressor of actin mutation (SAC) domain phosphatases. In some cases, these phosphatases also act on Ins(1,4,5)P(3). We have characterized the Arabidopsis (Arabidopsis thaliana) sac9 mutants. The SAC9 protein is different from other SAC domain proteins in several ways including the presence of a WW protein interaction domain within the SAC domain. The rice (Oryza sativa) and Arabidopsis SAC9 protein sequences are similar, but no apparent homologs are found in nonplant genomes. High-performance liquid chromatography studies show that unstressed sac9 mutants accumulate elevated levels of PtdIns(4,5)P(2) and Ins(1,4,5)P(3) as compared to wild-type plants. The sac9 mutants have characteristics of a constitutive stress response, including dwarfism, closed stomata, and anthocyanin accumulation, and they overexpress stress-induced genes and overaccumulate reactive-oxygen species. These results suggest that the SAC9 phosphatase is involved in modulating phosphoinsitide signals during the stress response.

Development and preliminary testing of a patient decision aid to assist pharmaceutical care in the prevention of cardiovascular disease.

STUDY OBJECTIVE: To develop and test a decision aid for patients with hypertension and/or dyslipidemia because a decision aid may assist in pharmaceutical care by providing relevant evidence-based information. DESIGN: Before and after use of a decision aid. SETTING: Hypertension clinic of a university hospital and a specialized coronary heart disease-prevention clinic. PATIENTS: A convenience sample of 16 patients receiving pharmacologic treatment for hypertension and/or dyslipidemia. INTERVENTION: A face-to-face interview was conducted before using the decision aid. This was followed by a telephone interview after the patient used the decision aid to assess the acceptability of the decision aid to the patient, as well as the patient's knowledge, risk perception, and decisional conflict. MEASUREMENTS AND MAIN RESULTS: The decision aid consists of a booklet containing general, evidence-based information and a personal worksheet. The worksheet provides information on patient risk factors, personal estimates of cardiovascular disease (CVD) risk, the benefits of treatment options, and values clarification exercise. It invites patients to specify an action plan and follow their own progress over time. Most patients (86-93%) rated the presentation of the information as excellent or very good, 80% judged the information about lifestyle changes and drug therapy to be balanced, 93% rated the amount of information "just right," and 100% found the decision aid useful. After using the decision aid, patients had higher knowledge scores for general risk factors (before, 91%; after, 100%, p=0.014), personal risk factors (73%, 92%, p=0.016), and treatment options (68%, 99%, p<0.001). More patients were able to estimate correctly their CVD risk category (50%, 93%, p=0.03) and their absolute 10-year CVD risk (0%, 93%, p<0.001), whereas the overall decisional conflict score decreased (p=0.007). CONCLUSION: The decision aid was acceptable to patients and improved their knowledge, risk perception, and decisional conflict. Therefore, the feasibility and impact of using the decision aid in community pharmacies and medical clinics should be assessed.

Validation of a tool to assess health practitioners' decision support and communication skills.

As patients become more involved in decisions affecting their health, it is important to monitor and improve the support clinicians provide to facilitate shared decision making. The Decision Support Analysis Tool (DSAT) was developed as a research tool to evaluate practitioners' use of decision support and related communication skills during a clinical encounter. The DSAT, consisting of six categories of decision support skills and four categories of communication skills, was tested with 34 actual transcripts of patient-physician dialogue. The patients were prepared for the clinical encounter with either a detailed decision aid plus worksheet (n=16) or a pamphlet (n=18). Pairs of raters, blinded to the intervention allocation, coded each transcript independently. The overall inter-rater agreement and kappa coefficients were, respectively 75% and 0.59 for the decision support skills and 76% and 0.68 for the communication skills categories. The frequency of DSAT skills coded: (a) were significantly correlated with three out of six patient and physician outcome measures (r>0.30, P<0.05); and (b) showed significant discrimination (P=0.05) or trends (P<0.15) in discrimination between the decision aid and pamphlet groups. The DSAT shows promise as a reliable and valid evaluation tool but requires further testing with larger samples.

The effect of decision aids on the agreement between women's and physicians' decisional conflict about hormone replacement therapy.

The aim of this secondary analysis was to compare the effects of a tailored decision aid (DA) with those of a pamphlet on the agreement between women's and physicians' decisional conflict about hormone replacement therapy (HRT). A total of 40 physicians and 184 women provided data. The agreement between women's and physicians' decisional conflict scores was measured using the intraclass correlation coefficient (ICC). The ICC was higher for dyads in the DA group (ICC=0.44; 95% confidence interval (CI)=0.25-0.59) compared to the pamphlet group (ICC=0.28; 95% CI=0.06-0.47). When the average score of decisional conflict of women nested within a physician and of each physician were used, the ICC for the DA group and the pamphlet group was 0.41 (95% CI=-0.04 to 0.72) and 0.06 (95% CI=-0.41 to 0.49), respectively. Compared to pamphlets, DAs appear to improve the agreement between women's and physicians' decisional conflict about HRT.

A survey of the decision-making needs of Canadians faced with complex health decisions.

OBJECTIVE: To describe the decision-making needs of Canadians when faced with 'complex' health decisions characterized by balancing advantages against disadvantages. Although a national report emphasized that public confidence in the health-care system depends on support for personal knowledge and decision-making, there has been no systematic investigation of the Canadian population's decision-making needs. DESIGN: Cross-sectional telephone survey using random digit dialling. PARTICIPANTS: National sample of 635 adults over 18 years of age, living in Canada. RESULTS: Forty-two percentage of eligible contacts participated. Sixty-five percent of contacts reported making 'complex' health decisions, commonly about medical or surgical treatments or birth control, and more commonly by women and by married/separated individuals. Most respondents took an active role in their decisions, often sharing the process with their partner or family. Being younger was associated with a more independent role. Physicians were more often involved in the decisions of respondents with less education. Fifty-nine percent of respondents experienced decisional conflict; more conflict was seen with those who were female and feeling uninformed about options, pressured to select one particular option, and unready or unskilled in decision-making. Less decisional conflict was seen in those who reported birth control decisions and in those who were 70 years and older. Participants used several strategies when deliberating about choices including: information gathering, clarifying their values, and seeking support and information from others. Personal counselling and printed information materials were commonly preferred methods of learning about options. 'Essential' criteria for judging satisfactory decision-making included: having sufficient knowledge about the options, outcomes, and probabilities; being clear about values; selecting and implementing a choice that agrees with personal values; and expressing satisfaction with the choice. CONCLUSIONS: Canadians, particularly women, face difficult decisions and need support and information from credible sources.

The effect of qualitative vs. quantitative presentation of probability estimates on patient decision-making: a randomized trial.

BACKGROUND: Given the greater uncertainty surrounding probability estimates associated with qualitative (use of words or phrases) descriptions, the use of quantitative (numerical) information to communicate the risks and benefits of therapies is recommended but the impact of its use in decision aids is unexplored. OBJECTIVE: Using stroke prevention in atrial fibrillation as an example, to compare the impact of quantitative vs. qualitative descriptions of probability risk estimates in decision aids on the clinical decision-making process. DESIGN: Randomized trial with a 2 x 2 factorial design. SUBJECTS: A total of 198 volunteers aged 60-80 years. SETTING: Outpatient clinics of a university-affiliated, tertiary-care teaching hospital. METHODS: Participants were asked to imagine that they had atrial fibrillation, and using a decision aid, were then randomized to two ways of receiving pertinent risk information regarding the probability of stroke and major bleeding when taking warfarin, aspirin or no therapy: (1) quantitatively, in which the 2-year probabilities of stroke and major haemorrhage were presented both numerically and graphically with 100 faces (e.g. 8 of 100), and (2) qualitatively in which these probabilities were presented with the use of verbal phrases (e.g. very low, moderate). OUTCOME MEASURES: Primary: decisional conflict. Secondary: participants' choices, knowledge and expectations of outcomes using qualitative and quantitative scales. RESULTS: Participants reviewing quantitative risk information scored better on the informed subscale of the decisional conflict scale (P < 0.05) and, as expected, were better able to estimate numerically their chance of stroke and bleeding when taking warfarin, aspirin or no medication. For the low risk arm, there were no significant differences in treatment choices for the qualitative and quantitative groups. For the moderate risk arm, treatment choices between the two groups were significantly different (P = 0.01), with those in the quantitative group more likely to make an actual choice and to choose therapies at the extremes of effectiveness (warfarin and no treatment). There were no significant differences between the quantitative and qualitative groups in their ability to rank-order their stroke risk when taking warfarin, aspirin and no treatment, overall knowledge about atrial fibrillation and its treatment, and other dimensions of decisional conflict (all P-values >0.05). CONCLUSIONS: For participants without the disease in question, this study found that providing sufficient quantitative risk information makes them feel more informed, which sometimes affects their treatment choices. Further studies are necessary to confirm these findings for patients making actual clinical decisions.