CM-SHARE: Development, Integration, and Adoption of an Electronic Health Record-Linked Digital Health Solution to Support Care for Diabetes in Primary Care.

IN BRIEF Chronic conditions such as diabetes are largely managed by primary care providers (PCPs), with significant patient self-management. This article describes the development, pilot testing, and fine-tuning of a Web-based digital health solution to help PCPs manage patients with cardiometabolic diseases during routine office encounters. It shows that such products can be successfully integrated into primary care settings when they address important unmet needs and are developed with input from end-users.

Human Factors Results for Fentanyl Iontophoretic Transdermal System (ITS) With Enhanced Controller for Postoperative Pain Management.

PURPOSE: The purpose of this analysis was to conduct summative usability evaluations, including behavioral and subjective evaluations, for the fentanyl iontophoretic transdermal system (ITS). DESIGN: Four usability studies were conducted in representative users. METHODS: The first three studies were conducted with (1) health care professionals (HCPs; N = 31), (2) patients who received placebo fentanyl ITS (N = 30), and (3) healthy volunteers (N = 30), and focused on the understanding and use of fentanyl ITS. The fourth study included HCPs (N = 31) and healthy volunteers (N = 30), and focused on the effectiveness of formal training regarding the use of fentanyl ITS. FINDINGS: Overall, user groups found the fentanyl ITS easy to use. There were no use errors that could potentially have safety implications. In the three early studies, there were some minor difficulties experienced; however, the introduction of a structured training reduced these difficulties. CONCLUSIONS: Patients, nurses, and pharmacists were able to use fentanyl ITS with ease.

Meta-Analysis of the Ease of Care From a Patients' Perspective Comparing Fentanyl Iontophoretic Transdermal System Versus Morphine Intravenous Patient-Controlled Analgesia in Postoperative Pain Management.

PURPOSE: The purpose of this meta-analysis was to evaluate patients' assessment of fentanyl iontophoretic transdermal system (ITS) and morphine intravenous patient-controlled analgesia (IV PCA) ease of care (EOC) using a validated patient EOC questionnaire. Fentanyl ITS is a preprogrammed, needle-free PCA system used for the management of acute pain in postoperative patients. METHODS: This meta-analysis assessed the patient EOC of fentanyl ITS and morphine IV PCA using data from three randomized, active-comparator trials in adult postoperative patients with moderate-to-severe pain. All three studies utilized a validated patient EOC questionnaire which consists of 23 items grouped into seven subscales (confidence with device, comfort with device, movement, dosing confidence, pain control, knowledge/understanding, and satisfaction). Each item is scored on a six-point Likert scale. The weighted mean difference between treatments was calculated for the overall EOC and for each of the seven subscales. RESULTS: The EOC analyses were based on responses to questionnaires from 1,943 patients treated with either fentanyl ITS (n = 961) or morphine IV PCA (n = 982). There was a statistically significant advantage in favor of fentanyl ITS over morphine IV PCA in terms of overall EOC (weighted mean difference = 0.28; 95% confidence interval (0.22 to 0.34); P < 0.0001). Five of the seven subscales (confidence with device, comfort with device, movement, dosing confidence, and knowledge/understanding) on the patient EOC questionnaire showed a statistically significant advantage for fentanyl ITS versus morphine IV PCA. The two subscales that did not show any difference were pain control (P = 0.7303) and satisfaction (0.0561). CONCLUSION: In this meta-analysis, fentanyl ITS is associated with some advantages in terms of an EOC profile from a patients' perspective when compared with morphine IV PCA.

Meta-Analysis of the Ease of Care From the Nurses' Perspective Comparing Fentanyl Iontophoretic Transdermal System (ITS) Vs Morphine Intravenous Patient-Controlled Analgesia (IV PCA) in Postoperative Pain Management.

PURPOSE: The aim of this meta-analysis was to compare the ease of care (EOC) of fentanyl iontophoretic transdermal system (ITS) vs the morphine intravenous patient-controlled analgesia (IV PCA) as assessed by the nurse. DESIGN: Meta-analysis of three phase 3B randomized active-comparator trials. METHODS: This meta-analysis according to Cochrane's approach assessed EOC using a validated nurse questionnaire (22 items grouped into three subscales, which include time efficiency, convenience, and satisfaction) in adult patients treated with fentanyl ITS or morphine IV PCA for postoperative pain management. The weighted mean difference (WMD) between treatments was calculated. FINDING: EOC analyses were based on responses to questionnaires from 848 (fentanyl ITS) and 761 (morphine IV PCA) nurses. Fentanyl ITS was reported to provide significant advantages compared with morphine IV PCA in terms of nurses' overall EOC (WMD = -0.57, P < .0001) and each of the subscales: time efficiency (WMD = -0.58, P < .0001), convenience (WMD = -0.57, P < .0001), and satisfaction (WMD = -0.47, P < .0001). CONCLUSIONS: In this meta-analysis, fentanyl ITS is associated with a superior EOC profile from the nurses' perspective than morphine IV PCA.

Effect of Financial Incentives to Physicians, Patients, or Both on Lipid Levels: A Randomized Clinical Trial.

IMPORTANCE: Financial incentives to physicians or patients are increasingly used, but their effectiveness is not well established. OBJECTIVE: To determine whether physician financial incentives, patient incentives, or shared physician and patient incentives are more effective than control in reducing levels of low-density lipoprotein cholesterol (LDL-C) among patients with high cardiovascular risk. DESIGN, SETTING, AND PARTICIPANTS: Four-group, multicenter, cluster randomized clinical trial with a 12-month intervention conducted from 2011 to 2014 in 3 primary care practices in the northeastern United States. Three hundred forty eligible primary care physicians (PCPs) were enrolled from a pool of 421. Of 25,627 potentially eligible patients of those PCPs, 1503 enrolled. Patients aged 18 to 80 years were eligible if they had a 10-year Framingham Risk Score (FRS) of 20% or greater, had coronary artery disease equivalents with LDL-C levels of 120 mg/dL or greater, or had an FRS of 10% to 20% with LDL-C levels of 140 mg/dL or greater. Investigators were blinded to study group, but participants were not. INTERVENTIONS: Primary care physicians were randomly assigned to control, physician incentives, patient incentives, or shared physician-patient incentives. Physicians in the physician incentives group were eligible to receive up to $1024 per enrolled patient meeting LDL-C goals. Patients in the patient incentives group were eligible for the same amount, distributed through daily lotteries tied to medication adherence. Physicians and patients in the shared incentives group shared these incentives. Physicians and patients in the control group received no incentives tied to outcomes, but all patient participants received up to $355 each for trial participation. MAIN OUTCOMES AND MEASURES: Change in LDL-C level at 12 months. RESULTS: Patients in the shared physician-patient incentives group achieved a mean reduction in LDL-C of 33.6 mg/dL (95% CI, 30.1-37.1; baseline, 160.1 mg/dL; 12 months, 126.4 mg/dL); those in physician incentives achieved a mean reduction of 27.9 mg/dL (95% CI, 24.9-31.0; baseline, 159.9 mg/dL; 12 months, 132.0 mg/dL); those in patient incentives achieved a mean reduction of 25.1 mg/dL (95% CI, 21.6-28.5; baseline, 160.6 mg/dL; 12 months, 135.5 mg/dL); and those in the control group achieved a mean reduction of 25.1 mg/dL (95% CI, 21.7-28.5; baseline, 161.5 mg/dL; 12 months, 136.4 mg/dL; P < .001 for comparison of all 4 groups). Only patients in the shared physician-patient incentives group achieved reductions in LDL-C levels statistically different from those in the control group (8.5 mg/dL; 95% CI, 3.8-13.3; P = .002). CONCLUSIONS AND RELEVANCE: In primary care practices, shared financial incentives for physicians and patients, but not incentives to physicians or patients alone, resulted in a statistically significant difference in reduction of LDL-C levels at 12 months. This reduction was modest, however, and further information is needed to understand whether this approach represents good value. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01346189.

Beyond the threshold: real-time use of evidence in practice.

In two landmark reports on Quality and Information Technology, the Institute of Medicine described a 21st century healthcare delivery system that would improve the quality of care while reducing its costs. To achieve the improvements envisioned in these reports, it is necessary to increase the efficiency and effectiveness of the clinical decision support that is delivered to clinicians through electronic health records at the point of care. To make these dramatic improvements will require significant changes to the way in which clinical practice guidelines are developed, incorporated into existing electronic health records (EHR), and integrated into clinicians' workflow at the point of care. In this paper, we: 1) discuss the challenges associated with translating evidence to practice; 2) consider what it will take to bridge the gap between the current limits to use of CPGs and expectations for their meaningful use at the point of care in practices with EHRs; 3) describe a framework that underlies CDS systems which, if incorporated in the development of CPGs, can be a means to bridge this gap, 4) review the general types and adoption of current CDS systems, and 5) describe how the adoption of EHRs and related technologies will directly influence the content and form of CPGs. Achieving these objectives should result in improvements in the quality and reductions in the cost of healthcare, both of which are necessary to ensure a 21st century delivery system that consistently provides safe and effective care to all patients.

Do Patients Continue to Use Video Visits? Factors Related to Continued Video Visit Use.

Many studies have assessed the factors associated with overall video visit use during the COVID-19 pandemic, but little is known about who is most likely to continue to use video visits and why. The authors combined a survey with electronic health record data to identify factors affecting the continued use of video visit. In August 2020, a stratified random sample of 20,000 active patients from a large health care system were invited to complete an email survey on health care seeking preferences during the COVID. Weighted logistic regression models were applied, adjusting for sampling frame and response bias, to identify factors associated with video visit experience, and separately for preference of continued use of video visits. Actual video visit utilization was also estimated within 12 months after the survey. Three thousand three hundred fifty-one (17.2%) patients completed the survey. Of these, 1208 (36%) reported having at least 1 video visit in the past, lowest for African American (33%) and highest for Hispanic (41%). Of these, 38% would prefer a video visit in the future. The strongest predictors of future video visit use were comfort using video interactions (odds ratio [OR] = 5.30, 95% confidence interval [95% CI]: 3.57-7.85) and satisfaction with the overall quality (OR = 3.94, 95% CI: 2.66-5.86). Interestingly, despite a significantly higher satisfaction for Hispanic (40%-55%) and African American (40%-50%) compared with Asian (29%-39%), Hispanic (OR = 0.46, 95% CI: 0.12-0.88) and African American (OR = 0.54, 95% CI: 0.16-0.90) were less likely to prefer a future video visit. Disparity exists in the use of video visit. The association between patient satisfaction and continued video visit varies by race/ethnicity, which may change the future long-term video visit use among race/ethnicity groups.

Persistent Cardiometabolic Health Gaps: Can Therapeutic Care Gaps Be Precisely Identified from Electronic Health Records.

The objective of this study was to determine the strengths and limitations of using structured electronic health records (EHR) to identify and manage cardiometabolic (CM) health gaps. We used medication adherence measures derived from dispense data to attribute related therapeutic care gaps (i.e., no action to close health gaps) to patient- (i.e., failure to retrieve medication or low adherence) or clinician-related (i.e., failure to initiate/titrate medication) behavior. We illustrated how such data can be used to manage health and care gaps for blood pressure (BP), low-density lipoprotein cholesterol (LDL-C), and HbA1c for 240,582 Sutter Health primary care patients. Prevalence of health gaps was 44% for patients with hypertension, 33% with hyperlipidemia, and 57% with diabetes. Failure to retrieve medication was common; this patient-related care gap was highly associated with health gaps (odds ratios (OR): 1.23-1.76). Clinician-related therapeutic care gaps were common (16% for hypertension, and 40% and 27% for hyperlipidemia and diabetes, respectively), and strongly related to health gaps for hyperlipidemia (OR = 5.8; 95% CI: 5.6-6.0) and diabetes (OR = 5.7; 95% CI: 5.4-6.0). Additionally, a substantial minority of care gaps (9% to 21%) were uncertain, meaning we lacked evidence to attribute the gap to either patients or clinicians, hindering efforts to close the gaps.

Moderating Effects of Patient Characteristics on the Impact of Financial Incentives.

While financial incentives to providers or patients are increasingly common as a quality improvement strategy, their impact on patient subgroups and health care disparities is unclear. To examine these patterns, we analyzed data from a randomized clinical trial of financial incentives to lower low-density lipoprotein (LDL) cholesterol levels in patients at risk for cardiovascular disease. Patients with higher baseline LDL experienced greater cholesterol reductions in the shared incentive arm (0.23 mg/dL per unit change in baseline LDL, 95% CI [-0.46, -0.00]) but were also less likely to have medication potency increases in the physician incentive arm ( OR = 0.98, 95% CI [0.97, 0.996]). Uninsured patients and those of race other than Black or White were less likely to have potency increases in the shared incentive arm ( OR = 0.15, 95% CI [0.03, 0.70] and OR = 0.09, 95% CI [0.01, 0.93], respectively). These findings suggest some differential response to incentives, particularly in the form of targeted medication changes.

Patient considerations in the use of transdermal iontophoretic fentanyl for acute postoperative pain.

Opioids are commonly used in the management of moderate-to-severe postoperative pain. Patient-controlled analgesic techniques are recognized as preferred administration methods. Previously, research has focused on intravenously administered opioids via a programmable pump. More recently, an iontophoretic transdermal system (ITS), which is patient controlled, has been developed. The focus of this review is on pain management using the fentanyl ITS during the 24-72-hour time period immediately following surgery. Fentanyl ITS offers a needle-free alternative to traditional intravenous (IV) patient-controlled analgesia (PCA) system that is as effective and safe as IV PCA. This system is easy to use for both patients and nurses. The use of fentanyl ITS is generally associated with a better ease-of-care profile, including a greater ease of mobility, from a patients' perspective when compared with morphine IV PCA.

Fentanyl iontophoretic transdermal system versus morphine intravenous patient-controlled analgesia for pain management following orthopedic surgery: A pooled analysis of randomized, controlled trials.

OBJECTIVE: To compare the efficacy and safety of patient-controlled pain management following orthopedic surgery using either fentanyl iontophoretic transdermal system (ITS) or morphine intravenous (i.v.) patient-controlled analgesia (PCA). SETTING: Acute Care Hospital. PATIENTS: Three-open-label, multicenter, randomized, active-controlled, parallel-group phase 3B studies (N = 2095) were conducted that compared fentanyl ITS with morphine i.v. PCA for postoperative pain in hospitalized postoperative patients. A subgroup of orthopedic surgery patients (N = 1,216) was pooled for this analysis; of which 819 completed treatment. INTERVENTIONS: A total of 590 patients received fentanyl ITS (40 µg/dose) and 626 patients received morphine i.v. PCA (1 mg/dose) for up to 72 hours. MAIN OUTCOME MEASURES: Efficacy measures included the patient global assessment (PGA) and the investigator global assessment (IGA) of the method of pain control. RESULTS: Patients had a mean age of about 60 years, were predominantly Caucasian (90.5 percent), and the majority underwent hip replacement (80.3 percent). There were more patients treated with fentanyl ITS who rated their pain control method as "excellent" compared to morphine i.v. PCA at 24 hours postsurgery (44.8 percent vs 33.0 percent, respectively; p < 0.001), 48 hours (37.5 percent vs 25.3 percent, respectively; p < 0.001), and at the last assessment (54.3 percent vs 39.6 percent, respectively; p < 0.001). There were more investigators who rated treatment with fentanyl ITS as "excellent" compared to morphine i.v. PCA at the last assessment (57.4 percent vs 36.9 percent, respectively; p < 0.001). CONCLUSIONS: Following orthopedic surgery, patients and investigators more frequently reported global assessment of pain control as "excellent" on the PGA and IGA assessments with fentanyl ITS than with morphine i.v. PCA.

A comparison of opioid-related adverse events with fentanyl iontophoretic transdermal system versus morphine intravenous patient-controlled analgesia in acute postoperative pain.

OBJECTIVE: This analysis compared opioid-related adverse events (ORADEs) observed with fentanyl iontophoretic transdermal system (ITS) versus morphine intravenous (iv.) patient-controlled analgesia (PCA) in the management of postoperative pain. METHODS: Safety data from four Phase IIIB randomized, active-comparator trials were pooled for this analysis (n = 1288 fentanyl ITS and 1313 morphine iv. PCA patients). Treatment-emergent adverse events were collected via spontaneous report. In this post hoc analysis, ORADEs were defined as apnea, confusion, constipation, dyspnea, hypotension, hypoventilation, hypoxia, ileus, nausea, pruritus, somnolence, tachycardia, urinary retention and vomiting. Odds ratios (OR) and 95% CI were calculated for all ORADEs and p-values were based on logistic regression with treatment as effect. RESULTS: There were fewer patients in the fentanyl ITS group compared with the morphine iv. PCA group who experienced at least one ORADE (52.7 vs 59.1%, respectively; OR: 0.772: 95% CI: 0.661-0.901; p = 0.0011). The ORADEs that occurred less frequently in the fentanyl ITS group than in the morphine iv. PCA group included hypotension (3.7 vs 5.5%, respectively; OR: 0.667; 95% CI: 0.459-0.969; p = 0.0338), hypoventilation (0.9 vs 1.9%, respectively; OR: 0.444; 95% CI: 0.217-0.906; p = 0.0256), nausea (40.3 vs 44.5%, respectively; OR: 0.842; 95% CI: 0.721-0.984; p = 0.0310), pruritus (5.5 vs 9.4%, respectively; OR: 0.559; 95% CI: 0.413-0.757; p = 0.0002) and tachycardia (1.6 vs 2.8%, respectively; OR: 0.489; 95% CI: 0.277-0.863; p = 0.0136). No ORADEs occurred more frequently in the fentanyl ITS group compared with the morphine iv. PCA group. CONCLUSION: Fentanyl ITS, in the management of acute postoperative pain, offered safety advantages in terms of ORADEs compared with morphine iv. PCA.

Development of the fentanyl iontophoretic transdermal system (ITS) for patient-controlled analgesia of postoperative pain management.

The fentanyl iontophoretic transdermal system (ITS) is a needle-free, patient-activated drug delivery system used for patient-controlled analgesia in adult hospitalized patients with postoperative pain. The system design has been updated to a separated system consisting of a Controller and a Drug Unit, and has had regulatory submissions in USA and Europe in 2014. Fentanyl ITS has been shown to be therapeutically equivalent to morphine intravenous (iv.) patient-controlled analgesia. One of the advantages of fentanyl ITS is that patients have better mobility as there is no need for an iv. pump, iv. lines and pole. The introduction of the updated fentanyl ITS will add a versatile tool to the postoperative pain management armamentarium.

Fentanyl iontophoretic transdermal system versus morphine intravenous patient-controlled analgesia for pain management following gynecological surgery: a meta-analysis of randomized, controlled trials.

AIM: To compare the efficacy and safety of patient-controlled fentanyl iontophoretic transdermal system (ITS) with morphine intravenous (i.v.) patient-controlled analgesia (PCA) for pain management following gynecological surgery. METHODS: Two-open-label, multicenter, randomized, active-controlled, parallel-group studies (n = 1142) were conducted that compared fentanyl ITS with morphine iv. PCA for postoperative pain. The subgroup of gynecological surgery patients from each trial was utilized for this meta-analysis (n = 604). Of these patients, 295 received fentanyl ITS (40 µg/dose) and 309 received morphine i.v. PCA (1 mg/dose) for up to 72 h. Efficacy measures included the patient global assessment (PGA) and the investigator global assessment (IGA) of the method of pain control. RESULTS: Gynecological surgery patients (n = 604) included in this meta-analysis had a mean age of 45 years, were predominantly Caucasian (65%) and had a mean body mass index of 29 mg/kg2. There were statistically significantly more patients treated with fentanyl ITS and more investigators who rated their pain control method as 'excellent' on the PGA at 24 h (49.3 vs 37.4%, respectively; p = 0.0029) and IGA at the last assessment (59.5 vs. 38.0%, respectively; p < 0.0001), respectively, compared with morphine iv. PCA at the last assessment. CONCLUSION: Following gynecological surgery, patients and investigators were more satisfied (had a higher percent of an 'excellent' rating on the PGA and IGA, respectively) with fentanyl ITS than morphine iv. PCA as a method of pain control.

Meta-analysis of the efficacy of the fentanyl iontophoretic transdermal system versus intravenous patient-controlled analgesia in postoperative pain management.

OBJECTIVE: This meta-analysis was conducted to analyze and compare the efficacy outcomes associated with the fentanyl iontophoretic transdermal system (ITS) and morphine intravenous (IV) patient-controlled analgesia (PCA) in the management of postoperative pain. RESEARCH DESIGN AND METHODS: This meta-analysis assessed the efficacy of the fentanyl ITS versus morphine IV PCA using data from four randomized, active-controlled trials (n = 1271 fentanyl ITS and 1298 morphine IV PCA patients). Main outcome measures were patient global assessment (PGA) of the method of pain control at 24 h. RESULTS: Fentanyl ITS and morphine IV PCA did not significantly differ regarding 'good' and 'excellent' ratings on the PGA of the method of pain control at 24 h (odds ratio = 0.95, p = 0.66), however, fentanyl ITS was superior in terms of 'excellent' PGA ratings at that time point (odds ratio = 1.53, p < 0.0001). No significant differences were found in weighted mean pain intensity scores at 24, 48 and 72 h. CONCLUSIONS: In this meta-analysis, fentanyl ITS was as efficacious as morphine IV PCA and may offer additional benefits as demonstrated by its 'excellent' PGA ratings.

Droperidol vs prochlorperazine for the treatment of acute headache.

To determine if droperidol i.v. is as effective as prochlorperazine i.v. in the emergency department (ED) treatment of uncomplicated headache, a randomized, controlled, blinded study was conducted in the Emergency Departments of two urban teaching hospitals. Patients >or= 18 years old with crescendo-onset headache were eligible for inclusion. Ninety-six patients (48 in each group) were randomized to receive droperidol 2.5 mg i.v. or prochlorperazine 10 mg i.v. Baseline characteristics were similar between the two study groups. For the main study outcome, 83.3% in the droperidol group and 72.3% in the prochlorperazine group reported 50% pain reduction at 30 min (p <.01; one-sided test of equivalence). The mean decrease in headache intensity was 79.1% (SD 28.5%) in the droperidol group and 72.1% (SD 28.0%) in the prochlorperazine group (p =.23). It is concluded that droperidol i.v. provided a similar reduction of headache as achieved with prochlorperazine i.v. with a similar incidence of akathisia.

Electronic health record-based assessment of oral corticosteroid use in a population of primary care patients with asthma: an observational study.

BACKGROUND: Oral corticosteroid prescriptions are often used in clinical studies as an indicator of asthma exacerbations. However, there is rarely the ability to link a prescription to its associated diagnosis. The objective of this study was to characterize patterns of oral corticosteroid prescription orders for asthma patients using an electronic health record database, which links each prescription order to the diagnosis assigned at the time the order was placed. METHODS: This was a retrospective cohort study of the electronic health records of asthma patients enrolled in the Geisinger Health System from January 1, 2001 to August 23, 2010. Eligible patients were 12-85 years old, had a primary care physician in the Geisinger Health System, and had asthma. Each oral corticosteroid order was classified as being prescribed for an asthma-related or non-asthma-related condition based on the associated diagnosis. Asthma-related oral corticosteroid use was classified as either chronic or acute. In patient-level analyses, we determined the number of asthma patients with asthma-related and non-asthma-related prescription orders and the number of patients with acute versus chronic use. Prescription-level analyses ascertained the percentages of oral corticosteroid prescription orders that were for asthma-related and non-asthma-related conditions. RESULTS: Among the 21,199 asthma patients identified in the electronic health record database, 15,017 (70.8%) had an oral corticosteroid prescription order. Many patients (N = 6,827; 45.5%) had prescription orders for both asthma-related and non-asthma-related conditions, but some had prescription orders exclusively for asthma-related (N = 3,450; 23.0%) or non-asthma-related conditions (N = 4,740; 31.6%). Among the patients receiving a prescription order, most (87.5%) could be classified as acute users. A total of 60,355 oral corticosteroid prescription orders were placed for the asthma patients in this study-31,397 (52.0%) for non-asthma-related conditions, 24,487 (40.6%) for asthma-related conditions, and 4,471 (7.4%) for both asthma-related and non-asthma-related conditions. CONCLUSIONS: Oral corticosteroid prescriptions for asthma patients are frequently ordered for conditions unrelated to asthma. A prescription for oral corticosteroids may be an unreliable marker of asthma exacerbations in retrospective studies utilizing administrative claims data. Investigators should consider co-morbid conditions for which oral corticosteroid use may also be indicated and/or different criteria for assessing oral corticosteroid use for asthma.

The relative efficacy and safety of clopidogrel in women and men a sex-specific collaborative meta-analysis.

OBJECTIVES: This study sought to investigate the efficacy and safety of clopidogrel in women and men. BACKGROUND: Previous analyses have shown sex-based differences in response to several antiplatelet medications. Little is known about the efficacy and safety of clopidogrel in women and men. METHODS: This study performed a meta-analysis of all blinded randomized clinical trials comparing clopidogrel and placebo (CURE [Clopidogrel in Unstable Angina to Prevent Recurrent Events], CREDO [Clopidogrel for the Reduction of Events During Observation], CLARITY-TIMI 28 [Clopidogrel as Adjunctive Reperfusion Therapy-Thrombolysis In Myocardial Infarction 28], COMMIT [Clopidogrel and Metoprolol in Myocardial Infarction Trial], and CHARISMA [Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance] trials), involving a total of 79,613 patients, of whom 30% were women. The relative efficacy and safety of clopidogrel at reducing cardiovascular events (cardiovascular death, myocardial infarction [MI], or stroke) in women and men was estimated using random-effects modeling. RESULTS: Overall, clopidogrel was associated with a highly significant 14% proportional reduction in the risk of cardiovascular events (odds ratio [OR]: 0.86; 95% confidence interval [CI]: 0.80 to 0.93), with no significant differences in treatment effect between women and men. Among the 23,533 women enrolled, there were fewer cardiovascular events in the clopidogrel group compared with the placebo group (11.0% vs. 11.8%; OR: 0.93; 95% CI: 0.86 to 1.01). In women the risk reduction with clopidogrel seemed to be greatest for MI (OR: 0.81; 95% CI: 0.70 to 0.93), with the effects on stroke (OR: 0.91; 95% CI: 0.69 to 1.21) or total death (OR: 0.99; 95% CI: 0.90 to 1.08) not statistically significant. Among the 56,091 men enrolled, there were fewer cardiovascular events in those receiving clopidogrel compared with placebo (7.8% vs. 9.0%; OR: 0.84; 95% CI: 0.78 to 0.91), and the risk reduction was significant for MI (OR: 0.83; 95% CI: 0.76 to 0.92), stroke (OR: 0.83; 95% CI: 0.71 to 0.96), and total death (OR: 0.91; 95% CI: 0.84 to 0.97). Clopidogrel increased the risk of major bleeding in both women (OR: 1.43; 95% CI: 1.15 to 1.79) and men (OR: 1.22; 95% CI: 1.05 to 1.42). CONCLUSIONS: Clopidogrel reduces the risk of cardiovascular events in both women and men.

Randomized, placebo-controlled trial of Saforis for prevention and treatment of oral mucositis in breast cancer patients receiving anthracycline-based chemotherapy.

BACKGROUND: Oral mucositis (OM) is a frequent complication of mucotoxic cancer therapy, causing significant oral pain, increased infection risk, and impaired functioning. The efficacy and safety of Saforis (glutamine) powder in UpTec for oral suspension was evaluated for the prevention and treatment of OM. METHODS: Three hundred twenty-six patients developing World Health Organization (WHO) grade >or=2 OM during a chemotherapy screening cycle were randomized to Saforis (n = 163) or placebo (n = 163) 3 times/day during their next chemotherapy cycle (Treatment Cycle 1). Patients were crossed over to the alternate treatment during Treatment Cycle 2. As prespecified in the statistical plan, because of a carryover effect in Treatment Cycle 2 the primary efficacy analysis was based on Treatment Cycle 1 only. RESULTS: Compared with placebo, Saforis significantly reduced the incidence of clinically significant WHO grade >or=2 OM (38.7% vs. 49.7%; P = .026) and severe WHO grade >or=3 OM (1.2% vs. 6.7%; P = .005) in Treatment Cycle 1. Saforis also significantly reduced the worst Oral Mucositis Assessment Scale ulceration score in Treatment Cycle 1 compared with placebo (mean, 0.23 +/- 0.39 vs. 0.32 +/- 0.45; P = .013). Patients receiving Saforis in Treatment Cycle 1 had a lower-than-expected OM incidence when crossed over to placebo in Treatment Cycle 2, indicating a significant carryover effect (P = .027). The incidence of treatment-emergent adverse events was similar between groups. CONCLUSIONS: Saforis is safe and effective for preventing and treating OM in patients receiving mucotoxic cancer chemotherapy.

Issues in the design of Internet-based systems for collecting patient-reported outcomes.

BACKGROUND AND OBJECTIVES: Although there is a growing interest in using patient-reported outcomes (PRO) to monitor disease progression and/or therapeutic response, to improve care, and to screen for physical or psychosocial problems in routine clinical practice, PRO instruments can be difficult to administer, score, and interpret in this setting. Internet-based approaches to PRO collection may help overcome these obstacles. This paper discusses the rationale for using the Internet for routine PRO collection, summarizes relevant literature and ongoing projects, and raises several key design and development issues that should guide further efforts in this area. MAJOR FINDINGS: A small number of Internet-based PRO collection applications have been or are currently being developed. The major characteristics of several of these projects are reviewed and summarized. Successful Internet-based PRO collection applications must address patient and clinician-specific needs related to workflow and to the way in which results are presented. A growing number of instruments have been adapted for and evaluated in a web-based format. CONCLUSIONS: Collecting PROs via the Internet has the potential to overcome many of the challenges associated with efforts to routinely use PROs in the clinical encounter.