Before the door: Comparing factors affecting symptom onset to first medical contact for STEMI patients between a high and low-middle income country.

Background: Early reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) has been associated with preservation of left ventricular function and decrease in mortality. Symptom onset to first medical contact (FMC) time consumes the majority of total ischemic time, and remains one of the main reasons that patients do not receive timely care. With FMC to reperfusion time being effectively reduced in many parts of the world, the focus is now shifting to reducing symptom onset to FMC times. Methods: This mixed-methods observational study was designed to elucidate factors affecting symptom onset to FMC time at a regional cardiac center in a low-middle income country (LMIC) and a high-income country (HIC). A review of the Aswan Heart Center and Hamilton General Hospital STEMI registry in Egypt and Canada was conducted, and retrospective semi-structured questionnaires carried out for a convenience sample of 158 patients. Results: Gender, symptom type and severity were none-modifiable factors found between early and late presenters. Modifiable factors found were actions of bystanders, actions of patients, transportation method and time. Emotional factors also showed differences between the two groups. Conclusion: While some concepts are generalizable, contextual differences in demographics, risk factors, access and knowledge are identified. These factors can be used to inform tailored knowledge translation strategies to help reduce symptom onset to FMC in both LMIC and HIC.

Comparison of Heart Team vs Interventional Cardiologist Recommendations for the Treatment of Patients With Multivessel Coronary Artery Disease.

Importance: Although the heart team approach is recommended in revascularization guidelines, the frequency with which heart team decisions differ from those of the original treating interventional cardiologist is unknown. Objective: To examine the difference in decisions between the heart team and the original treating interventional cardiologist for the treatment of patients with multivessel coronary artery disease. Design, Setting, and Participants: In this cross-sectional study, 245 consecutive patients with multivessel coronary artery disease were recruited from 1 high-volume tertiary care referral center (185 patients were enrolled through a screening process, and 60 patients were retrospectively enrolled from the center's database). A total of 237 patients were included in the final virtual heart team analysis. Treatment decisions (which comprised coronary artery bypass grafting, percutaneous coronary intervention, and medication therapy) were made by the original treating interventional cardiologists between March 15, 2012, and October 20, 2014. These decisions were then compared with pooled-majority treatment decisions made by 8 blinded heart teams using structured online case presentations between October 1, 2017, and October 15, 2018. The randomized members of the heart teams comprised experts from 3 domains, with each team containing 1 noninvasive cardiologist, 1 interventional cardiologist, and 1 cardiovascular surgeon. Cases in which all 3 of the heart team members disagreed and cases in which procedural discordance occurred (eg, 2 members chose coronary artery bypass grafting and 1 member chose percutaneous coronary intervention) were discussed in a face-to-face heart team review in October 2018 to obtain pooled-majority decisions. Data were analyzed from May 6, 2019, to April 22, 2020. Main Outcomes and Measures: The Cohen κ coefficient between the treatment recommendation from the heart team and the treatment recommendation from the original treating interventional cardiologist. Results: Among 234 of 237 patients (98.7%) in the analysis for whom complete data were available, the mean (SD) age was 67.8 (10.9) years; 176 patients (75.2%) were male, and 191 patients (81.4%) had stenosis in 3 epicardial coronary vessels. A total of 71 differences (30.3%; 95% CI, 24.5%-36.7%) in treatment decisions between the heart team and the original treating interventional cardiologist occurred, with a Cohen κ of 0.478 (95% CI, 0.336-0.540; P = .006). The heart team decision was more frequently unanimous when it was concordant with the decision of the original treating interventional cardiologist (109 of 163 cases [66.9%]) compared with when it was discordant (28 of 71 cases [39.4%]; P < .001). When the heart team agreed with the original treatment decision, there was more agreement between the heart team interventional cardiologist and the original treating interventional cardiologist (138 of 163 cases [84.7%]) compared with when the heart team disagreed with the original treatment decision (14 of 71 cases [19.7%]); P < .001). Those with an original treatment of coronary artery bypass grafting, percutaneous coronary intervention, and medication therapy, 32 of 148 patients [22.3%], 32 of 71 patients [45.1%], and 6 of 15 patients [40.0%], respectively, received a different treatment recommendation from the heart team than the original treating interventional cardiologist; the difference across the 3 groups was statistically significant (P = .002). Conclusions and Relevance: The heart team's recommended treatment for patients with multivessel coronary artery disease differed from that of the original treating interventional cardiologist in up to 30% of cases. This subset of cases was associated with a lower frequency of unanimous decisions within the heart team and less concordance between the interventional cardiologists; discordance was more frequent when percutaneous coronary intervention or medication therapy were considered. Further research is needed to evaluate whether heart team decisions are associated with improvements in outcomes and, if so, how to identify patients for whom the heart team approach would be beneficial.

Radial artery versus femoral artery access options in coronary angiogram procedures: randomized controlled trial of a patient-decision aid.

BACKGROUND: Vascular access options in coronary angiography can be considered a preference-sensitive decision, where the benefits/risks have different levels of significance, depending on the individual patient. For preference-sensitive healthcare options, patient decision aids (PtDA) significantly improve the process of decision-making. The purpose of this trial was to evaluate the effectiveness of an evidence-based PtDA compared with usual care in patients eligible for radial and femoral artery access. METHODS AND RESULTS: We conducted a single-center, nonblinded, randomized controlled trial with patients eligible for both femoral and radial access as per their treating physician. The PtDA was designed to guide patients to make an informed choice, consistent with their preferences and values. The primary outcome, decisional conflict, was assessed using the validated decisional conflict scale. One hundred fifty patients were randomized (vascular access PtDA=76 versus usual care=74). The intervention group had a significantly reduced decisional conflict scale compared with control (unadjusted 14.8 versus 19.5, P=0.04) and were significantly more knowledgeable regarding risks/benefits associated with each vascular access (mean knowledge score 3/5 (95% confidence interval, 2.6 to 3.3) versus 2/5 (95% confidence interval, 1.7 to 2.3, P<0.01). PtDA patients had better informed value congruence with their vascular access received (47.3% versus 25.7%, P<0.01). There were no significant differences in procedural success or safety between the 2 groups. CONCLUSIONS: A vascular access PtDA for eligible patients undergoing coronary angiogram procedures reduces decisional conflict and improves value congruence and the patients' knowledge of their healthcare options; however, a multicenter study, powered to confirm these benefits and evaluate differences in procedural success or complications, is required.

Long-term outcomes with paclitaxel-eluting stents versus bare metal stents in everyday practice: a Canadian experience.

BACKGROUND: In randomized trials, paclitaxel-eluting stents (PES) are superior to bare metal stents (BMS) in reducing target lesion revascularization (TLR). However, recent reports suggest there may be an increase in late stent thrombosis with long-term follow-up in PES-treated patients. METHODS: Prospectively collected data from a regional cardiac referral centre were analyzed to compare PES versus BMS in all consecutive patients undergoing percutaneous coronary intervention from April 2003 to March 2004. Outcomes included combined death, myocardial infarction and clinically driven TLR, as well as stent thrombosis at four years follow-up. RESULTS: A total of 512 patients were treated with PES and 722 patients with BMS. At four years, there was 92% follow-up in both groups. The composite outcome of death, myocardial infarction and TLR was 13.9% in the PES group compared with 20% in the BMS group (P=0.01). This difference was primarily driven by the reduction in TLR in the PES cohort (3.9% versus 8%, P<0.01). The rate of definite stent thrombosis was 1.6% in the PES group compared with 0.4% in the BMS group (P=0.03). CONCLUSION: While PES offers an absolute 4.1% reduction in clinically driven TLR at four years, there is an associated increased risk of stent thrombosis. Further long-term studies addressing clinical outcomes including stent thrombosis with PES versus BMS are required to clarify this risk/ benefit balance.

Comparison of one-year clinical outcomes with paclitaxel-eluting stents versus bare metal stents in everyday practice.

BACKGROUND: In randomized trials, paclitaxel-eluting stents (PES) have been shown to be superior to bare metal stents (BMS) in reducing restenosis. However, the effectiveness of PES in patients treated during routine practice has not been fully established. METHODS: A retrospective comparison of PES with BMS in consecutive patients undergoing percutaneous coronary intervention (PCI) from April 2003 to March 2004 was conducted. Outcomes included the composite of death, myocardial infarction and target lesion revascularization (TLR) at one year, as well as stent thrombosis. RESULTS: A total of 512 patients were treated with PES, and 722 patients were treated with BMS. Patients in the PES group were more likely to receive stents that were 20 mm in length or longer (52.2% versus 33.3%, P<0.0001), 2.5 mm in diameter or smaller (29.1% versus 12.5%, P<0.0001) and implanted in bifurcation positions (15.4% versus 11.6%, P=0.02). At one year, the composite outcome of death, myocardial infarction and TLR was 6.1% in the PES group compared with 10.8% in the BMS group (P=0.004). The one-year rate of stent thrombosis was 0.59% in the PES group compared with 0.28% in the BMS group (P=0.4). CONCLUSIONS: Despite being used in higher-risk lesions, there was a lower rate of major cardiac events at one year in patients treated with PES, primarily driven by the reduction in TLR. Thus, the experience with PES in contemporary practice applied to a broader population appears to be consistent with the results reported in randomized trials.

Validation of a prediction model to estimate health utilities index Mark 3 utility scores from WOMAC index scores in patients with osteoarthritis of the hip.

OBJECTIVE: To examine the validity of a newly developed prediction model translating osteoarthritis (OA)-specific health-related quality of life (HRQL) scores measured using the Western Ontario and McMaster Osteoarthritis Index (WOMAC) into generic utility-based HRQL scores measured using the Health Utilities Index Mark 3 (HUI3). METHODS: Preintervention data from 145 patients with hip OA and complete WOMAC and HUI3 baseline assessments from the Alberta Hip Improvement Project study were used to validate three utility prediction models. These models were estimated using data from a previous study of knee OA patients. Predictive performance was assessed using the mean absolute prediction error (MAE) criterion and several other criteria. RESULTS: The validation sample appeared healthier (on the basis of the HUI3 and WOMAC) than the subjects used toestimate the prediction models. Nevertheless, the validation sample outperformed the predictive performance of the model sample. The results from the validation sample support the conclusions from the original study in that the primary model identified during model development (a model using WOMAC subscales, their interactions, their square terms, age, OA duration, their square terms, and gender) performed better on the MAE criterion than competing models. CONCLUSION: These results support the external validity of the prediction model for the retrospective estimation of HUI3 utility scores for use in economic evaluation.

A model to estimate health utilities index mark 3 utility scores from WOMAC index scores in patients with osteoarthritis of the knee.

OBJECTIVE: To develop a formula to translate Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores collected in clinical trials of patients with osteoarthritis (OA) into Health Utilities Index Mark 3 (HUI3) utility scores for application in economic evaluation. METHODS: Data from a previously published open-label randomized controlled trial of appropriate care with hylan G-F 20 versus appropriate care without hylan G-F 20 in 255 outpatients with knee OA. We estimated linear regression models of HUI3 scores using various functions of WOMAC, demographics, and clinical variables. Out-of-sample predictive performance of the models was assessed using the mean absolute error and several other criteria. RESULTS: The preferred formula included WOMAC pain, stiffness, function subscales, demographic variables; it accounted for almost 40% of the variation in the HUI3 utility scores. At the group level, absolute differences between predicted and actual overall HUI3 utility scores were < 0.001 and not statistically significantly different from zero. CONCLUSION: A formula was derived from the WOMAC index to estimate overall utility scores based on the HUI3 for studies of patients with OA for whom utility has not been recorded. Researchers can estimate overall utility scores, compute quality-adjusted life-years, and perform cost-utility analyses within a defined range of certainty.

BLISS index for analyzing knee osteoarthritis trials data.

OBJECTIVES: Different pain thresholds were investigated, using the WOMAC Pain Scale (WOMAC-P) to determine if they could differentiate between treatment groups (hylan G-F 20 vs. appropriate care) at low and very low levels of state attainment in patients with knee osteoarthritis (OA). A method, termed the BLISS (Bellamy et al. Low Intensity Symptom State-attainment) Index, for analyzing OA knee clinical trials data, was proposed. STUDY DESIGN AND SETTING: Five analyses were performed: time to first BLISS day, BLISS days over 12 months, patients with a BLISS response at month 12, patients with a BLISS response at any time, and number of BLISS periods over 12 months. For each analysis, five levels of WOMAC-P were examined:

Economic evaluation of controlled-release oxycodone vs oxycodone-acetaminophen for osteoarthritis pain of the hip or knee.

OBJECTIVE: To examine, in routine practice, the effectiveness and cost-effectiveness of oxycodone (OxyContin) compared with standard therapy for osteoarthritis pain. STUDY DESIGN: Open-label active-controlled randomized naturalistic 4-month study of oxycodone vs a combination of oxycodone-acetaminophen (Percocet). METHODS: Outcomes and health resource utilization data were collected by telephone interview. Effectiveness was measured among 485 patients as the proportion having at least 20% improvement from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index pain score. Quality-adjusted life-years (QALYs) were calculated from the Health Utilities Index 3 score. Cost-effectiveness was measured as cost per patient improved and the QALYs gained, using generic oxycodone-acetaminophen in the base case for the healthcare and societal perspectives. Uncertainty was evaluated using multiple 1-way sensitivity analyses and cost-effectiveness acceptability curves. RESULTS: Improvement occurred in 62.2% of patients with oxycodone and in 45.9% of patients with oxycodone-acetaminophen (P < .001). After adjustment for baseline differences, 0.0105 QALYs were gained with oxycodone compared with oxycodone-acetaminophen (P = .17). The mean societal costs per patient during 4 months were 7379 US dollars and 7528 US dollars for oxycodone and oxycodone-acetaminophen, respectively (P = .33). Oxycodone was more effective and less costly than oxycodone-acetaminophen based on the societal perspective (including costs associated with time lost). Based on the healthcare perspective (excluding costs associated with time lost), the cost-effectiveness of oxycodone was 4883 US dollars per patient improved and 75,810 US dollars per QALY gained. The base-case results were robust. CONCLUSIONS: From the societal perspective, oxycodone was more effective and less costly than oxycodone-acetaminophen. From the healthcare perspective, oxycodone (compared with generic oxycodone-acetaminophen) fell within the acceptable range of cost-effectiveness between 50,000 US dollars and 100,000 US dollars per QALY gained.

The effectiveness of hylan G-F 20 in patients with knee osteoarthritis: an application of two sets of response criteria developed by the OARSI and one set developed by OMERACT-OARSI.

OBJECTIVE: Secondary analyses of a previously conducted 1-year randomized controlled trial were performed to assess the application of responder criteria in patients with knee osteoarthritis (OA) using different sets of responder criteria developed by the Osteoarthritis Research Society International (OARSI) (Propositions A and B) for intra-articular drugs and Outcome Measures in Arthritis Clinical Trials (OMERACT)-OARSI (Proposition D). METHODS: Two hundred fifty-five patients with knee OA were randomized to "appropriate care with hylan G-F 20" (AC+H) or "appropriate care without hylan G-F 20" (AC). A patient was defined as a responder at month 12 based on change in Western Ontario and McMaster Universities Osteoarthritis Index pain and function (0-100 normalized scale) and patient global assessment of OA in the study knee (at least one-category improvement in very poor, poor, fair, good and very good). All propositions incorporate both minimum relative and absolute changes. RESULTS: Results demonstrated that statistically significant differences in responders between treatment groups, in favor of hylan G-F 20, were detected for Proposition A (AC+H=53.5%, AC=25.2%), Proposition B (AC+H=56.7%, AC=32.3%) and Proposition D (AC+H=66.9%, AC=42.5%). The highest effectiveness in both treatment groups was observed with Proposition D, whereas Proposition A resulted in the lowest effectiveness in both treatment groups. The treatment group differences always exceeded the required 20% minimum clinically important difference between groups established a priori, and were 28.3%, 24.4% and 24.4% for Propositions A, B and D, respectively. CONCLUSION: This analysis provides evidence for the capacity of OARSI and OMERACT-OARSI responder criteria to detect clinically important statistically detectable differences between treatment groups.

Incidence, predictors, and clinical significance of troponin-I elevation without creatine kinase elevation following percutaneous coronary interventions.

The objectives of this study were to investigate the incidence, predictors, and clinical significance of isolated postprocedural troponin-I elevations in a consecutive series of patients who underwent percutaneous coronary intervention. We observed, in a series of 1,128 patients, that isolated troponin-I elevations without concomitant creatine kinase elevations occurred in 17% of patients after percutaneous coronary intervention, and that even troponin-I elevations 5 times above the upper limit of normal did not predict events after hospital discharge.

Pantoprazole rapidly improves health-related quality of life in patients with heartburn: a prospective, randomized, double blind comparative study with nizatidine.

BACKGROUND: Health-related quality of life (HRQoL) is impaired in untreated patients with gastroesophageal reflux disease (GERD). In the absence of an objective marker such as erosions, assessment of treatment efficacy can be based on symptoms and HRQoL. OBJECTIVE: To evaluate changes in HRQoL during treatment with pantoprazole or nizatidine in patients with GERD. METHODS: This was a prospective, randomized, double blind Canadian multicenter study. Patients with GERD, characterized by heartburn that had occurred 4 or more times per week for at least 6 months, were treated for 28 days with either pantoprazole 40 mg once daily or nizatidine 150 mg twice daily. HRQoL assessment was performed before endoscopy (baseline) and on days 7 and 28 after treatment. HRQoL was assessed using 4 domains of the SF-36, the SF-12 summary scales and the gastrointestinal system rating scale (GSRS). RESULTS: A total of 208 patients (n = 106 pantoprazole treatment group, n = 102 nizatidine treatment group) was available for intention-to-treat analysis. Baseline HRQoL scores were comparable between the 2 treatment groups. After 7 days, treatment with pantoprazole led to a statistically significant greater improvement in HRQoL in 2 SF-36 domains: bodily pain (pantoprazole versus nizatidine, P = 0.0088) and vitality (pantoprazole versus nizatidine, P = 0.0137), and in the GSRS reflux score (pantoprazole versus nizatidine, P = 0.0078). After 28 days of treatment, the changes in scores relative to baseline were still greater with pantoprazole than with nizatidine. The improvement in the 4 SF-36 domains and the GSRS reflux score achieved by pantoprazole after 7 days were also significantly greater than those achieved by nizatidine after 28 days. CONCLUSIONS: HRQoL improves more rapidly and to a greater degree following treatment with pantoprazole than nizatidine. Control of heartburn strongly predicts HRQoL improvement during the acute treatment of GERD. Our data support the approach to use pantoprazole instead of nizatidine as the initial therapy for patients with heartburn in a primary care practice setting.

Validation of the GSFQ, a self-administered symptom frequency questionnaire for patients with gastroesophageal reflux disease.

BACKGROUND: Although the diagnosis of gastroesophageal reflux disease (GERD) is based primarily on symptoms experienced by a patient, relatively little attention has been paid to the development and validation of self-administered questionnaires specific to GERD symptoms. The present article presents the validation of the short, self-administered GERD Symptom Frequency Questionnaire (GSFQ). METHODS: Patients with GERD participating in a randomized clinical trial comparing pantoprazole and nizatidine were asked to complete the GSFQ together with validated instruments for measurement of health-related quality of life (Medical Outcome Study Short Form 12) and gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale). Completion of the GSFQ, Medical Outcome Study Short Form 12 and Gastrointestinal Symptom Rating Scale took place upon entry into the trial (baseline) and during the trial (days 7 and 28). Endoscopy was performed at baseline and after 28 days. Cronbach alpha was used to assess the internal consistency of the questionnaire. The test-retest reliability of the GSFQ was examined by the intraclass correlation coefficient among the 36 patients with stable GERD symptoms between day 7 and day 28. Construct validity was assessed by comparing the GSFQ with previously validated instruments. Known group validity was determined by comparing GSFQ scores across groups of patients known to differ clinically. Responsiveness to change was assessed by the Guyatt's statistic. RESULTS: Two hundred twenty-one patients formed the study baseline group. The analysis demonstrated that the GSFQ questionnaire had excellent psychometric properties shown by the high internal consistency (Cronbach alpha 0.84); that the test-retest reliability was satisfactory (intraclass correlation coefficient 0.64); that there was good evidence that the GSFQ indeed measured what it was intended to measure (validity); and that the GSFQ was highly responsive to change (Guyatt's statistic 1.48). DISCUSSION: The GSFQ is a short, self-administered, easy to use, GERD-specific questionnaire which should be considered as a useful assessment tool in the evaluation of patients with GERD and in the assessment of treatment outcomes.