PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-25 (920171)

Clipboard (0)
None

Related Articles

1.  A non-experimental study of oral anticoagulation therapy initiation before and after national patient safety goals 
BMJ Open  2014;4(2):e003960.
Objectives
The Joint Commission revised its National Patient Safety Goals (NPSGs) to include oral anticoagulation therapy (OAT) in 2008. We sought to examine the effect of including OAT in The Joint Commission's NPSGs on historically low rates of OAT initiation for individuals with incident atrial fibrillation (AF).
Setting
Southeastern state in the USA.
Participants
North Carolina State Health Plan claims data from 944 500 individuals enrolled between 1 January 2006 and 31 December 2010, supplemented with data from the Area Resource File and Online Survey, Certification and Reporting data network. We evaluated OAT initiation before and after the 2008 NPSGs revisions in a retrospective cohort new user design with an AF intervention group and two control groups: a positive control—patients estimated to be at very high risk of thromboembolism (mechanical heart valve and pulmonary embolism); and a negative control—patients with very low perceived risk of thromboembolism (paroxysmal AF). We developed multivariable models using a difference-in-difference parameterisation. Effects were estimated with generalised estimating equations.
Primary outcome measure
OAT initiation, a binary outcome defined as having a prescription drug claim for warfarin within 30 days of the index claim.
Results
OAT initiation was low (26.8%) for eligible individuals with incident AF in 2006–2008 but increased after NPSGs implementation (31.7%, p=0.022). OAT initiation was high but decreased in the positive control group (67.5% vs 62.0%, p=0.003). Multivariate analysis resulted in a relative 11% (95% CI (4% to 18%), p<0.01) increase in OAT initiation for incident AF patients.
Conclusions
We document a substantial increase in guideline concordant OAT initiation in incident AF after the establishment of NPSGs, suggesting that regulatory healthcare agency initiatives can influence clinical practice.
doi:10.1136/bmjopen-2013-003960
PMCID: PMC3927813  PMID: 24525389
2.  Reducing adverse self-medication behaviors in older adults with the Next Generation Personal Education Program (PEP-NG): Design and methodology 
A randomized controlled efficacy trial targeting older adults with hypertension is providing a tailored education intervention with a Next Generation Personal Education Program (PEP-NG) in primary care practices in New England. Ten participating advanced practice registered nurses (APRNs) completed online knowledge and self-efficacy measures pre-onsite training and twice more after completing a continuing education program. Patient participants self-refer in response to study recruitment brochures and posters. Twenty-four participants from each APRN practice (total N = 240) are randomly assigned by the PEP-NG software to either control (data collection and four routine APRN visits) or tailored intervention (PEP-NG interface and four focused APRN visits) conditions. Patients access the PEP-NG interface via wireless tablet and use a stylus to answer demographic, knowledge, and self-efficacy questions as well as prescription and over-the-counter self-medication practice questions. The PEP-NG analyzes patient-reported information and delivers tailored educational content. Patients’ outcome measures are self-reported antihypertensive medication adherence, blood pressure, knowledge and self-efficacy concerning potential adverse self-medication practices, adverse self-medication behavior “risk” score and satisfaction with the PEP-NG and APRN provider relationship. APRN outcome measures are knowledge and self-efficacy concerning adverse self-medication practices, self-efficacy for communicating with older adults and satisfaction with the PEP-NG. Time–motion and cost–benefit analyses will be conducted.
PMCID: PMC2792870  PMID: 20016796
hypertension; self-medication; older adults; tailored intervention; computer-based education
3.  Primary care management for optimized antithrombotic treatment [PICANT]: study protocol for a cluster-randomized controlled trial 
Background
Antithrombotic treatment is a continuous therapy that is often performed in general practice and requires careful safety management. The aim of this study is to investigate whether a best-practice model that applies major elements of case management and patient education, can improve antithrombotic management in primary healthcare in terms of reducing major thromboembolic and bleeding events.
Methods
This 24-month cluster-randomized trial will be performed with 690 adult patients from 46 practices. The trial intervention will be a complex intervention involving general practitioners, healthcare assistants, and patients with an indication for oral anticoagulation. To assess adherence to medication and symptoms in patients, as well as to detect complications early, healthcare assistants will be trained in case management and will use the Coagulation-Monitoring List (Co-MoL) to regularly monitor patients. Patients will receive information (leaflets and a video), treatment monitoring via the Co-MoL and be motivated to perform self-management. Patients in the control group will continue to receive treatment as usual from their general practitioners. The primary endpoint is the combined endpoint of all thromboembolic events requiring hospitalization and all major bleeding complications. Secondary endpoints are mortality, hospitalization, strokes, major bleeding and thromboembolic complications, severe treatment interactions, the number of adverse events, quality of anticoagulation, health-related quality of life, and costs. Further secondary objectives will be investigated to explain the mechanism by which the intervention is effective: patients’ assessment of chronic illness care, self-reported adherence to medication, general practitioners’ and healthcare assistants’ knowledge, and patients’ knowledge and satisfaction with shared decision making.
Practice recruitment is expected to take place between July and December 2012. Recruitment of eligible patients will start in July 2012. Assessment will occur at three time points: baseline and follow-up after 12 months and after 24 months.
Discussion
The efficacy and effectiveness of individual elements of the intervention, such as antithrombotic interventions, self-management concepts in orally anticoagulated patients, and the methodological tool of case management, have already been extensively demonstrated. This project foresees the combination of several proven instruments, as a result of which we expect to profit from a reduction in the major complications associated with antithrombotic treatment.
Trial registration
Current Controlled Trials ISRCTN41847489
doi:10.1186/1748-5908-7-79
PMCID: PMC3499320  PMID: 22929015
Oral anticoagulation; Best-practice model; Case management
4.  Emergency reversal of anticoagulation: from theory to real use of prothrombin complex concentrates. A retrospective Italian experience 
Blood Transfusion  2012;10(1):87-94.
Background
Prothrombin Complex Concentrates (PCC) are administered to normalise blood coagulation in patients receiving oral anticoagulant therapy (OAT). Rapid reversal of OAT is essential in case of major bleeding, internal haemorrhage or surgery.
The primary end-point was to evaluate whether PCC in our hospital were being used in compliance with international and national guidelines for the reversal of OAT on an emergency basis. The secondary end-point was to evaluate the efficacy and safety of PCC.
Materials and methods
All patients receiving OAT who required rapid reversal anticoagulation because they had to undergo emergency surgery or urgent invasive techniques following an overdose of oral anticoagulants were eligible for this retrospective observational study.
Results
Forty-seven patients receiving OAT who needed rapid reverse of anticoagulation were enrolled in our study. The patients were divided in two groups: (i) group A (n=23), patients needed haemostatic treatment before neurosurgery after a head injury and (ii) group B (n=24), patients with critical haemorrhage because of an overdose of oral anticoagulants. The International Normalised Ratio (INR) was checked before and after infusion of the PCC. The mean INR in group A was 2.7 before and 1.43 after infusion of the PCC; in group B the mean INR of 6.58, before and 1.92 after drug infusion. The use of vitamin K, fresh-frozen plasma and red blood cells was also considered. During our study 22 patients died, but no adverse effects following PCC administration were recorded.
Discussion
In our study three-factor-PCC was found to be effective and safe in rapidly reversing the effects of OAT, although it was not always administered in accordance with international or national guidelines. The dose, time of administration and monitoring often differed from those recommended. In the light of these findings, we advocate the use of single standard protocol to guide the correct use of PCC in each hospital ward.
doi:10.2450/2011.0030-11
PMCID: PMC3258994  PMID: 22044952
prothrombin complex concentrate; oral anticoagulant therapy; reversal of anticoagulation guidelines
5.  Multivariate relationships between international normalized ratio and vitamin K-dependent coagulation-derived parameters in normal healthy donors and oral anticoagulant therapy patients 
Thrombosis Journal  2003;1:7.
Background and objectives
International Normalized Ratio (INR) is a world-wide routinely used factor in the monitoring of oral anticoagulation treatment (OAT). However, it was reported that other factors, e. g. factor II, may even better reflect therapeutic efficacy of OAT and, therefore, may be potentialy useful for OAT monitoring. The primary purpose of this study was to characterize the associations of INR with other vitamin K-dependent plasma proteins in a heterogenous group of individuals, including healthy donors, patients on OAT and patients not receiving OAT. The study aimed also at establishing the influence of co-morbid conditions (incl. accompanying diseases) and co-medications (incl. different intensity of OAT) on INR.
Design and Methods
Two hundred and three subjects were involved in the study. Of these, 35 were normal healthy donors (group I), 73 were patients on medication different than OAT (group II) and 95 were patients on stable oral anticoagulant (acenocoumarol) therapy lasting for at least half a year prior to the study. The values of INR and activated partial thromboplastin time (APTT) ratio, as well as activities of FII, FVII, FX, protein C, and concentration of prothrombin F1+2 fragments and fibrinogen were obtained for all subjects. In statistical evaluation, the uni- and multivariate analyses were employed and the regression equations describing the obtained associations were estimated.
Results
Of the studied parameters, three (factors II, VII and X) appeared as very strong modulators of INR, protein C and prothrombin fragments F1+2 had moderate influence, whereas both APTT ratio and fibrinogen had no significant impact on INR variability. Due to collinearity and low tolerance of independent variables included in the multiple regression models, we routinely employed a ridge multiple regression model which compromises the minimal number of independent variables with the maximal overall determination coefficient. The best-fitted two-component model included FII and FVII activities and explained 90% of INR variability (compared to 93% in the 5-component model including all vitamin K-dependent proteins). Neither the presence of accompanying diseases nor the use of OAT nor any other medication (acetylsalicylic acid, statins, steroids, thyroxin) biased significantly these associations.
Conclusion
Among various vitamin K-dependent plasma proteins, the coagulation factors II, VII and X showed the most significant associations with INR. Of these variables, the two-component model, including factors II and VII, deserves special attention, as it largely explains the overall variability observed in INR estimates. The statistical power of this model is validated on virtue of the estimation that the revealed associations are rather universal and remain essentially unbiased by other compounding variables, including clinical status and medical treatment. Further, much broader population studies are needed to verify clinical usefulness of methods alternate or compounding to INR monitoring of OAT.
doi:10.1186/1477-9560-1-7
PMCID: PMC317378  PMID: 14969588
International Normalized Ratio (INR) of prothrombin time; clotting factors; protein C; prothrombin fragment F1+2; multivariate analysis
6.  A Randomized Controlled Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening among Latino Immigrants in a Primary Care Facility 
BACKGROUND
Latino immigrants face a higher burden of colorectal cancer (CRC) and screening rates are low.
OBJECTIVE
To assess the effectiveness of a multilevel intervention in increasing the rate of CRC screening among Latino immigrants.
DESIGN
A randomized controlled trial, with randomization at the physician level.
PARTICIPANTS
Pairs of 65 primary care physicians and 65 Latino immigrant patients participated, 31 in the intervention and 34 in the control group.
INTERVENTION
CRC educational video in Spanish on a portable personal digital video display device accompanied by a brochure with key information for the patient, and a patient-delivered paper-based reminder for their physician.
MEASUREMENTS
Completed CRC screening, physician recommendation for CRC screening, and patient adherence to physician recommended CRC screening.
RESULTS
The overall rate of completed screening for CRC was 55% for the intervention and 18% for the control group (p = 0.002). Physicians recommended CRC screening for 61% of patients in the intervention group versus 41% in the control group (p = 0.08). Of those that received a recommendation, 90% in the intervention group adhered to it versus 26% in the control group (p = 0.007).
CONCLUSIONS
The intervention was successful in increasing rates of completed CRC screening primarily through increasing adherence after screening was recommended. Additional efforts should focus on developing new strategies to increase physician recommendation for CRC screening, while employing effective patient adherence interventions.
doi:10.1007/s11606-010-1266-4
PMCID: PMC2869418  PMID: 20213208
colorectal cancer; immigrant health; primary care; prevention; intervention
7.  Point-of-Care International Normalized Ratio (INR) Monitoring Devices for Patients on Long-term Oral Anticoagulation Therapy 
Executive Summary
Subject of the Evidence-Based Analysis
The purpose of this evidence based analysis report is to examine the safety and effectiveness of point-of-care (POC) international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy (OAT).
Clinical Need: Target Population and Condition
Long-term OAT is typically required by patients with mechanical heart valves, chronic atrial fibrillation, venous thromboembolism, myocardial infarction, stroke, and/or peripheral arterial occlusion. It is estimated that approximately 1% of the population receives anticoagulation treatment and, by applying this value to Ontario, there are an estimated 132,000 patients on OAT in the province, a figure that is expected to increase with the aging population.
Patients on OAT are regularly monitored and their medications adjusted to ensure that their INR scores remain in the therapeutic range. This can be challenging due to the narrow therapeutic window of warfarin and variation in individual responses. Optimal INR scores depend on the underlying indication for treatment and patient level characteristics, but for most patients the therapeutic range is an INR score of between 2.0 and 3.0.
The current standard of care in Ontario for patients on long-term OAT is laboratory-based INR determination with management carried out by primary care physicians or anticoagulation clinics (ACCs). Patients also regularly visit a hospital or community-based facility to provide a venous blood samples (venipuncture) that are then sent to a laboratory for INR analysis.
Experts, however, have commented that there may be under-utilization of OAT due to patient factors, physician factors, or regional practice variations and that sub-optimal patient management may also occur. There is currently no population-based Ontario data to permit the assessment of patient care, but recent systematic reviews have estimated that less that 50% of patients receive OAT on a routine basis and that patients are in the therapeutic range only 64% of the time.
Overview of POC INR Devices
POC INR devices offer an alternative to laboratory-based testing and venipuncture, enabling INR determination from a fingerstick sample of whole blood. Independent evaluations have shown POC devices to have an acceptable level of precision. They permit INR results to be determined immediately, allowing for more rapid medication adjustments.
POC devices can be used in a variety of settings including physician offices, ACCs, long-term care facilities, pharmacies, or by the patients themselves through self-testing (PST) or self-management (PSM) techniques. With PST, patients measure their INR values and then contact their physician for instructions on dose adjustment, whereas with PSM, patients adjust the medication themselves based on pre-set algorithms. These models are not suitable for all patients and require the identification and education of suitable candidates.
Potential advantages of POC devices include improved convenience to patients, better treatment compliance and satisfaction, more frequent monitoring and fewer thromboembolic and hemorrhagic complications. Potential disadvantages of the device include the tendency to underestimate high INR values and overestimate low INR values, low thromboplastin sensitivity, inability to calculate a mean normal PT, and errors in INR determination in patients with antiphospholipid antibodies with certain instruments. Although treatment satisfaction and quality of life (QoL) may improve with POC INR monitoring, some patients may experience increased anxiety or preoccupation with their disease with these strategies.
Evidence-Based Analysis Methods
Research Questions
1. Effectiveness
Does POC INR monitoring improve clinical outcomes in various settings compared to standard laboratory-based testing?
Does POC INR monitoring impact patient satisfaction, QoL, compliance, acceptability, convenience compared to standard laboratory-based INR determination?
Settings include primary care settings with use of POC INR devices by general practitioners or nurses, ACCs, pharmacies, long-term care homes, and use by the patient either for PST or PSM.
2. Cost-effectiveness
What is the cost-effectiveness of POC INR monitoring devices in various settings compared to standard laboratory-based INR determination?
Inclusion Criteria
English-language RCTs, systematic reviews, and meta-analyses
Publication dates: 1996 to November 25, 2008
Population: patients on OAT
Intervention: anticoagulation monitoring by POC INR device in any setting including anticoagulation clinic, primary care (general practitioner or nurse), pharmacy, long-term care facility, PST, PSM or any other POC INR strategy
Minimum sample size: 50 patients Minimum follow-up period: 3 months
Comparator: usual care defined as venipuncture blood draw for an INR laboratory test and management provided by an ACC or individual practitioner
Outcomes: Hemorrhagic events, thromboembolic events, all-cause mortality, anticoagulation control as assessed by proportion of time or values in the therapeutic range, patient reported outcomes including satisfaction, QoL, compliance, acceptability, convenience
Exclusion criteria
Non-RCTs, before-after studies, quasi-experimental studies, observational studies, case reports, case series, editorials, letters, non-systematic reviews, conference proceedings, abstracts, non-English articles, duplicate publications
Studies where POC INR devices were compared to laboratory testing to assess test accuracy
Studies where the POC INR results were not used to guide patient management
Method of Review
A search of electronic databases (OVID MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library, and the International Agency for Health Technology Assessment [INAHTA] database) was undertaken to identify evidence published from January 1, 1998 to November 25, 2008. Studies meeting the inclusion criteria were selected from the search results. Reference lists of selected articles were also checked for relevant studies.
Summary of Findings
Five existing reviews and 22 articles describing 17 unique RCTs met the inclusion criteria. Three RCTs examined POC INR monitoring devices with PST strategies, 11 RCTs examined PSM strategies, one RCT included both PST and PSM strategies and two RCTs examined the use of POC INR monitoring devices by health care professionals.
Anticoagulation Control
Anticoagulation control is measured by the percentage of time INR is within the therapeutic range or by the percentage of INR values in the therapeutic range. Due to the differing methodologies and reporting structures used, it was deemed inappropriate to combine the data and estimate whether the difference between groups would be significant. Instead, the results of individual studies were weighted by the number of person-years of observation and then pooled to calculate a summary measure.
Across most studies, patients in the intervention groups tended to have a higher percentage of time and values in the therapeutic target range in comparison to control patients. When the percentage of time in the therapeutic range was pooled across studies and weighted by the number of person-years of observation, the difference between the intervention and control groups was 4.2% for PSM, 7.2% for PST and 6.1% for POC use by health care practitioners. Overall, intervention patients were in the target range 69% of the time and control patients were in the therapeutic target range 64% of the time leading to an overall difference between groups of roughly 5%.
Major Complications and Deaths
There was no statistically significant difference in the number of major hemorrhagic events between patients managed with POC INR monitoring devices and patients managed with standard laboratory testing (OR =0.74; 95% CI: 0.52- 1.04). This difference was non-significant for all POC strategies (PSM, PST, health care practitioner).
Patients managed with POC INR monitoring devices had significantly fewer thromboembolic events than usual care patients (OR =0.52; 95% CI: 0.37 - 0.74). When divided by POC strategy, PSM resulted in significantly fewer thromboembolic events than usual care (OR =0.46.; 95% CI: 0.29 - 0.72). The observed difference in thromboembolic events for PSM remained significant when the analysis was limited to major thromboembolic events (OR =0.40; 95% CI: 0.17 - 0.93), but was non-significant when the analysis was limited to minor thromboembolic events (OR =0.73; 95% CI: 0.08 - 7.01). PST and GP/Nurse strategies did not result in significant differences in thromboembolic events, however there were only a limited number of studies examining these interventions.
No statistically significant difference was observed in the number of deaths between POC intervention and usual care control groups (OR =0.67; 95% CI: 0.41 - 1.10). This difference was non-significant for all POC strategies. Only one study reported on survival with 10-year survival rate of 76.1% in the usual care control group compared to 84.5% in the PSM group (P=0.05).
Summary Results of Meta-Analyses of Major Complications and Deaths in POC INR Monitoring Studies
Patient Satisfaction and Quality of Life
Quality of life measures were reported in eight studies comparing POC INR monitoring to standard laboratory testing using a variety of measurement tools. It was thus not possible to calculate a quantitative summary measure. The majority of studies reported favourable impacts of POC INR monitoring on QoL and found better treatment satisfaction with POC monitoring. Results from a pre-analysis patient and caregiver focus group conducted in Ontario also indicated improved patient QoL with POC monitoring.
Quality of the Evidence
Studies varied with regard to patient eligibility, baseline patient characteristics, follow-up duration, and withdrawal rates. Differential drop-out rates were observed such that the POC intervention groups tended to have a larger number of patients who withdrew. There was a lack of consistency in the definitions and reporting for OAT control and definitions of adverse events. In most studies, the intervention group received more education on the use of warfarin and performed more frequent INR testing, which may have overestimated the effect of the POC intervention. Patient selection and eligibility criteria were not always fully described and it is likely that the majority of the PST/PSM trials included a highly motivated patient population. Lastly, a large number of trials were also sponsored by industry.
Despite the observed heterogeneity among studies, there was a general consensus in findings that POC INR monitoring devices have beneficial impacts on the risk of thromboembolic events, anticoagulation control and patient satisfaction and QoL (ES Table 2).
GRADE Quality of the Evidence on POC INR Monitoring Studies
CI refers to confidence interval; Interv, intervention; OR, odds ratio; RCT, randomized controlled trial.
Economic Analysis
Using a 5-year Markov model, the health and economic outcomes associated with four different anticoagulation management approaches were evaluated:
Standard care: consisting of a laboratory test with a venipuncture blood draw for an INR;
Healthcare staff testing: consisting of a test with a POC INR device in a medical clinic comprised of healthcare staff such as pharmacists, nurses, and physicians following protocol to manage OAT;
PST: patient self-testing using a POC INR device and phoning in results to an ACC or family physician; and
PSM: patient self-managing using a POC INR device and self-adjustment of OAT according to a standardized protocol. Patients may also phone in to a medical office for guidance.
The primary analytic perspective was that of the MOHLTC. Only direct medical costs were considered and the time horizon of the model was five years - the serviceable life of a POC device.
From the results of the economic analysis, it was found that POC strategies are cost-effective compared to traditional INR laboratory testing. In particular, the healthcare staff testing strategy can derive potential cost savings from the use of one device for multiple patients. The PSM strategy, however, seems to be the most cost-effective method i.e. patients are more inclined to adjust their INRs more readily (as opposed to allowing INRs to fall out of range).
Considerations for Ontario Health System
Although the use of POC devices continues to diffuse throughout Ontario, not all OAT patients are suitable or have the ability to practice PST/PSM. The use of POC is currently concentrated at the institutional setting, including hospitals, ACCs, long-term care facilities, physician offices and pharmacies, and is much less commonly used at the patient level. It is, however, estimated that 24% of OAT patients (representing approximately 32,000 patients in Ontario), would be suitable candidates for PST/PSM strategies and willing to use a POC device.
There are several barriers to the use and implementation of POC INR monitoring devices, including factors such as lack of physician familiarity with the devices, resistance to changing established laboratory-based methods, lack of an approach for identifying suitable patients and inadequate resources for effective patient education and training. Issues of cost and insufficient reimbursement strategies may also hinder implementation and effective quality assurance programs would need to be developed to ensure that INR measurements are accurate and precise.
Conclusions
For a select group of patients who are highly motivated and trained, PSM resulted in significantly fewer thromboembolic events compared to conventional laboratory-based INR testing. No significant differences were observed for major hemorrhages or all-cause mortality. PST and GP/Nurse use of POC strategies are just as effective as conventional laboratory-based INR testing for thromboembolic events, major hemorrhages, and all-cause mortality. POC strategies may also result in better OAT control as measured by the proportion of time INR is in the therapeutic range and there appears to be beneficial impacts on patient satisfaction and QoL. The use of POC devices should factor in patient suitability, patient education and training, health system constraints, and affordability.
Keywords
anticoagulants, International Normalized Ratio, point-of-care, self-monitoring, warfarin.
PMCID: PMC3377545  PMID: 23074516
8.  A Cluster-Randomized Trial of Decision Support Strategies for Reducing Antibiotic Use for Acute Bronchitis 
JAMA internal medicine  2013;173(4):267-273.
Background
National quality indicators show little change in the overuse of antibiotics for uncomplicated acute bronchitis. We compared the impact of two decision support strategies on antibiotic treatment of uncomplicated acute bronchitis.
Methods
We conducted a three-arm, cluster-randomized trial among 33 primary care practices belonging to an integrated health care system in central Pennsylvania. The printed intervention arm (n=11 practices) received decision support for acute cough illness through a print-based strategy, the computerized intervention group (n=11) received decision support through an electronic medical record-based strategy, and third group of practices (n=11) served as the control arm. Both intervention groups also received provider education and feedback on prescribing practices, and patient education brochures at check-in. Antibiotic prescription rates for uncomplicated acute bronchitis in the winter period (October 2009 – March 2010) following introduction of the intervention were compared with the previous three winter periods in an intent-to-treat analysis.
Results
Compared with the baseline period, the percentage of adolescents and adults prescribed antibiotics during the intervention period decreased at the printed (from 80.0% to 68.3%) and computerized intervention sites (from 74.0% to 60.7%), but increased slightly at the control sites (from 72.5% to 74.3%). After controlling for patient and provider characteristics, and clustering of observations by provider and practice site, the differences for the intervention groups were statistically significant from control (control vs. printed P=0.003; control vs. computerized P=0.014) but no among themselves (printed vs. computerized P=0.67). Changes in total visits, proportion diagnosed as uncomplicated acute bronchitis and thirty-day return visit rates were similar between study groups.
Conclusions
Implementation of a decision support strategy for acute bronchitis can help reduce overuse of antibiotics in primary care settings. The impact of printed and computerized strategies for providing decision support was equivalent. The study was registered with Clinical Trials.Gov prior to enrolling patients (NCT00981994).
doi:10.1001/jamainternmed.2013.1589
PMCID: PMC3582762  PMID: 23319069
9.  Safety and effectiveness of point-of-care monitoring devices in patients on oral anticoagulant therapy: a meta-analysis 
Open Medicine  2007;1(3):e131-e146.
Background
Point-of-care devices (POCDs) for monitoring long-term oral anticoagulation therapy (OAT) may be a useful alternative to laboratory-based international normalized ratio [INR] testing and clinical management.
Purpose
To determine clinical outcomes of the use of POCDs for OAT management by performing a meta-analysis. Previous meta-analyses on POCDs have serious limitations.
Data sources
PubMed, the Cochrane Library, DIALOG, MEDLINE, EMBASE, BIOSIS Previews and PASCAL databases.
Study selection
Randomized controlled trials of patients on long-term OAT, comparing anticoagulation monitoring by POCD with laboratory INR testing and clinical management.
Data extraction
1) rates of major hemorrhage; 2) rates of major thromboembolic events; 3) percentage of time that the patient is maintained within the therapeutic range; 4) deaths. Outcomes were compared using a random-effects model. Summary measures of rates were determined. The quality of studies was assessed using the Jadad scale.
Data synthesis
Seventeen articles (16 studies) were included. Data analysis showed that POCD INR testing reduced the risk of major thromboembolic events (odds ratio [OR] = 0.51; 95% confidence interval [CI] 0.35–0.74), was associated with fewer deaths (OR = 0.58; 95% CI = 0.38–0.89), and resulted in better INR control compared with laboratory INR testing. No significant difference between the two management modalities with respect to odds ratios for major hemorrhage was found.
Limitations
Quality scores varied from 1 to 3 (out of a maximum of 5). Only 3 studies defined how thromboembolic events would be diagnosed, casting doubt on the accuracy of the reporting of thromboembolic events. The studies suggest that only 24% of patients are good candidates for self-testing and self-management. Compared with patients managed with laboratory-based monitoring, POCD patients underwent INR testing at a much higher frequency and received much more intensive education on OAT management.
Conclusions
The use of POCDs is safe and may be more effective than laboratory-based monitoring. However, most patients are not good candidates for self-testing and self-management. Patient education and frequency of testing may be the most important factors in successful PODC management. Definitive conclusions about the clinical benefits provided by self-testing and self-management require more rigorously designed trials.
PMCID: PMC3113217  PMID: 21673942
10.  A Preliminary Trial of a Prototype Internet Dissonance-Based Eating Disorder Prevention Program for Young Women with Body Image Concerns 
Objective
A group dissonance-based eating disorder prevention program, in which young women critique the thin-ideal, reduces eating disorder risk factors and symptoms, but it can be difficult to identify school clinicians with the time and expertise to deliver the intervention. Thus, we developed a prototype Internet version of this program and evaluated it in a preliminary trial.
Method
Female college students with body dissatisfaction (N = 107; M age = 21.6 SD = 6.6) were randomized to the Internet intervention, group intervention, educational video condition or educational brochure condition.
Results
Internet and group participants showed greater pre-post reductions in eating disorder risk factors and symptoms than video controls (M d = .47 and .54 respectively) and brochure controls (M d = .75 and .72, respectively), with many effects reaching significance. Effects did not differ significantly for Internet versus group participants (M d = -.13) or for video versus brochure controls (M d = .25). Effect sizes for the Internet intervention were similar to those previously observed for group versions of this intervention.
Conclusions
Results suggest that this prototype Internet intervention is as efficacious as the group intervention, implying there would be merit in completing this intervention and evaluating it in a fully powered trial.
doi:10.1037/a0028016
PMCID: PMC3402630  PMID: 22506791
prevention; Internet; body dissatisfaction; eating disorder
11.  The implementation of a community-based aerobic walking program for mild to moderate knee osteoarthritis (OA): a knowledge translation (KT) randomized controlled trial (RCT): Part I: The Uptake of the Ottawa Panel clinical practice guidelines (CPGs) 
BMC Public Health  2012;12:871.
Background
The implementation of evidence based clinical practice guidelines on self-management interventions to patients with chronic diseases is a complex process. A multifaceted strategy may offer an effective knowledge translation (KT) intervention to promote knowledge uptake and improve adherence in an effective walking program based on the Ottawa Panel Evidence Based Clinical Practice Guidelines among individuals with moderate osteoarthritis (OA).
Methods
A single-blind, randomized control trial was conducted. Patients with mild to moderate (OA) of the knee (n=222) were randomized to one of three KT groups: 1) Walking and Behavioural intervention (WB) (18 males, 57 females) which included the supervised community-based aerobic walking program combined with a behavioural intervention and an educational pamphlet on the benefits of walking for OA; 2) Walking intervention (W) (24 males, 57 females) wherein participants only received the supervised community-based aerobic walking program intervention and the educational pamphlet; 3) Self-directed control (C) (32 males, 52 females) wherein participants only received the educational pamphlet. One-way analyses of variance were used to test for differences in quality of life, adherence, confidence, and clinical outcomes among the study groups at each 3 month assessment during the 12-month intervention period and 6-month follow-up period.
Results
Short-term program adherence was greater in WB compared to C (p<0.012) after 3 months. No statistical significance (p> 0.05) was observed for long-term adherence (6 to 12 months), and total adherence between the three groups. The three knowledge translation strategies demonstrated equivalent long-term results for the implementation of a walking program for older individuals with moderate OA. Lower dropout rates as well as higher retention rates were observed for WB at 12 and 18 months.
Conclusion
The additional knowledge translation behavioural component facilitated the implementation of clinical practice guidelines on walking over a short-term period. More studies are needed to improve the long-term walking adherence or longer guidelines uptake on walking among participants with OA. Particular attention should be taken into account related to patient’s characteristic and preference. OA can be managed through the implementation of a walking program based on clinical practice guidelines in existing community-based walking clubs as well as at home with the minimal support of an exercise therapist or a trained volunteer.
Trial Registration
Current Controlled Trials IRSCTNO9193542
doi:10.1186/1471-2458-12-871
PMCID: PMC3491047  PMID: 23061875
Osteoarthritis; Clinical trial; Walking; Adherence; Education; Behavioural intervention; Guidelines implementation; Knowledge translation
12.  A diabetes education multimedia program in the waiting room setting 
Diabetes Therapy  2011;2(3):178-188.
Introduction
This study evaluated the impact of a waiting room-administered, low-literacy, computer multimedia diabetes education program on patient self-management and provider intensification of therapy.
Methods
In this randomized, controlled trial, 129 participants either viewed a computer multimedia education program (intervention group) or read an educational brochure (control group) while in the waiting room. Participants were uninsured, primarily ethnic minority adults with type 2 diabetes receiving care from a county clinic in Chicago, Illinois. Wilcoxon test, t-test, and linear mixed model analyses evaluated changes in diabetes knowledge, self-efficacy, behaviors, medications prescribed, hemoglobin A1c (HbA1c), and blood pressure levels over 3 months.
Results
During the study period, there was an increase in the number of oral diabetes medications prescribed over three months to multimedia users compared with those in the control group (P=0.017). HbA1c declined by 1.5 in the multimedia group versus 0.8 in the control group (P=0.06). There were no differences between groups in changes in blood pressure levels, self-efficacy, and most diabetes-related behaviors. Self-reported exercise increased in the control group compared with the multimedia group (0.9 days/week vs. 0.1 days/week, P=0.016).
Conclusion
Multimedia users received a greater intensification of diabetes therapy, but demonstrated no difference in self-management in comparison with those receiving educational brochures. The availability of a computer multimedia program in the waiting room appears to be a novel and acceptable approach in providing diabetes education for underserved populations.
doi:10.1007/s13300-011-0007-y
PMCID: PMC3173596  PMID: 22127826
computer-assisted instruction; diabetes education; ethnic groups; health literacy
13.  A diabetes education multimedia program in the waiting room setting 
Diabetes Therapy  2011;2(3):178-188.
Introduction
This study evaluated the impact of a waiting room-administered, low-literacy, computer multimedia diabetes education program on patient self-management and provider intensification of therapy.
Methods
In this randomized, controlled trial, 129 participants either viewed a computer multimedia education program (intervention group) or read an educational brochure (control group) while in the waiting room. Participants were uninsured, primarily ethnic minority adults with type 2 diabetes receiving care from a county clinic in Chicago, Illinois. Wilcoxon test, t-test, and linear mixed model analyses evaluated changes in diabetes knowledge, self-efficacy, behaviors, medications prescribed, hemoglobin A1c (HbA1c), and blood pressure levels over 3 months.
Results
During the study period, there was an increase in the number of oral diabetes medications prescribed over three months to multimedia users compared with those in the control group (P=0.017). HbA1c declined by 1.5 in the multimedia group versus 0.8 in the control group (P=0.06). There were no differences between groups in changes in blood pressure levels, self-efficacy, and most diabetes-related behaviors. Self-reported exercise increased in the control group compared with the multimedia group (0.9 days/week vs. 0.1 days/week, P=0.016).
Conclusion
Multimedia users received a greater intensification of diabetes therapy, but demonstrated no difference in self-management in comparison with those receiving educational brochures. The availability of a computer multimedia program in the waiting room appears to be a novel and acceptable approach in providing diabetes education for underserved populations.
doi:10.1007/s13300-011-0007-y
PMCID: PMC3173596  PMID: 22127826
computer-assisted instruction; diabetes education; ethnic groups; health literacy
14.  Intracerebral haemorrhage: an often neglected medical emergency 
Abstract
Intracerebral haemorrhage (ICH) is the deadliest form of stroke, carrying a mortality rate between 30% and 55%, increasing to 67% in patients on oral anticoagulant therapy (OAT). Despite its relevant incidence, the treatment of ICH has been until recently a largely neglected item, addressed by only a few trials. Early treatment of ICH in non-anticoagulated patients with recombinant activated factor VII (rFVII) has been demonstrated to be able to limit the growth of the haematoma, but such a promising result requires further confirmations. In ICH patients receiving OAT a prompt reversal of the anticoagulant effect should be warranted in order to reduce the consequences of this dreadful adverse event. In clinical practice, however, just a small proportion of anticoagulated patients receive this treatment, probably because of the fear of thromboembolic complications. It is now time to check our way of thinking about ICH, regarding and treating it as a compelling medical emergency.
doi:10.1007/s11739-007-0009-y
PMCID: PMC2780614  PMID: 17551684
Intracerebral haemorrhage; Oral anticoagulants; Antiplatelet drugs; Recombinant activated factor VII; Emergency medicine
15.  Is stopping of anticoagulant therapy really required in a minor dental surgery? - How about in an endodontic microsurgery? 
Nowadays, oral anticoagulants are commonly prescribed to numerous patients for preventing cardiovascular accident such as thromboembolism. An important side effect of anticoagulant is anti-hemostasis. In a major surgery, the oral anticoagulant therapy (OAT) regimen must be changed before the surgery for proper post-operative bleeding control. However, in a minor dental surgery and endodontic surgery, the necessity for changing or discontinuing the OAT is open to debate. In this study, risks of the consequences were weighed and analyzed. In patients who stop the OAT, the occurrence of thromboembolic complication is rare but the result is fatal. In patients who continuing the OAT, post-operative bleeding can be controlled well with the local hemostatic measures. In the endodontic surgery, there are almost no studies about this issue. The intra-operative bleeding control is particularly important in the endodontic surgery because of its delicate and sensitive procedures such as inspection of resected root surface using dental microscope and retrograde filling. Further studies are necessary about this issue in the viewpoint of endodontic surgery.
doi:10.5395/rde.2013.38.3.113
PMCID: PMC3761118  PMID: 24010076
Anticoagulants; Bleeding control; Endodontic microsurgery; Hemorrhage; Post-operative bleeding; Thromboembolism
16.  No harm from five year ingestion of oats in coeliac disease 
Gut  2002;50(3):332-335.
Background: Six to 12 months of ingestion of moderate amounts of oats does not have a harmful effect in adult patients with coeliac disease. As the safety of long term intake of oats in coeliac patients is not known, we continued our previous 6–12 month study for five years.
Aim: To assess the safety of long term ingestion of oats in the diet of coeliac patients.
Patients: In our previous study, the effects of a gluten free diet and a gluten free diet including oats were compared in a randomised trial involving 92 adult patients with coeliac disease (45 in the oats group, 47 in the control group). After the initial phase of 6–12 months, patients in the oats group were allowed to eat oats freely in conjunction with an otherwise gluten free diet. After five years, 35 patients in the original oats group (23 still on an oats diet) and 28 in the control group on a conventional gluten free diet were examined.
Methods: Clinical and nutritional assessment, duodenal biopsies for conventional histopathology and histomorphometry, and measurement of antiendomysial, antireticulin, and antigliadin antibodies.
Results: There were no significant differences between controls and those patients consuming oats with respect to duodenal villous architecture, inflammatory cell infiltration of the duodenal mucosa, or antibody titres after five years of follow up. In both groups histological and histomorphometric indexes improved equally with time.
Conclusions: This study provides the first evidence of the long term safety of oats as part of a coeliac diet in adult patients with coeliac disease. It also appears that the majority of coeliac patients prefer oats in their diet.
PMCID: PMC1773136  PMID: 11839710
coeliac disease; gluten free diet; oats; villous atrophy
17.  A heart failure self-management program for patients of all literacy levels: A randomized, controlled trial [ISRCTN11535170] 
Background
Self-management programs for patients with heart failure can reduce hospitalizations and mortality. However, no programs have analyzed their usefulness for patients with low literacy. We compared the efficacy of a heart failure self-management program designed for patients with low literacy versus usual care.
Methods
We performed a 12-month randomized controlled trial. From November 2001 to April 2003, we enrolled participants aged 30–80, who had heart failure and took furosemide. Intervention patients received education on self-care emphasizing daily weight measurement, diuretic dose self-adjustment, and symptom recognition and response. Picture-based educational materials, a digital scale, and scheduled telephone follow-up were provided to reinforce adherence. Control patients received a generic heart failure brochure and usual care. Primary outcomes were combined hospitalization or death, and heart failure-related quality of life.
Results
123 patients (64 control, 59 intervention) participated; 41% had inadequate literacy. Patients in the intervention group had a lower rate of hospitalization or death (crude incidence rate ratio (IRR) = 0.69; CI 0.4, 1.2; adjusted IRR = 0.53; CI 0.32, 0.89). This difference was larger for patients with low literacy (IRR = 0.39; CI 0.16, 0.91) than for higher literacy (IRR = 0.56; CI 0.3, 1.04), but the interaction was not statistically significant. At 12 months, more patients in the intervention group reported monitoring weights daily (79% vs. 29%, p < 0.0001). After adjusting for baseline demographic and treatment differences, we found no difference in heart failure-related quality of life at 12 months (difference = -2; CI -5, +9).
Conclusion
A primary care-based heart failure self-management program designed for patients with low literacy reduces the risk of hospitalizations or death.
doi:10.1186/1472-6963-6-30
PMCID: PMC1475568  PMID: 16533388
18.  Culturally Adapted Hypertension Education (CAHE) to Improve Blood Pressure Control and Treatment Adherence in Patients of African Origin with Uncontrolled Hypertension: Cluster-Randomized Trial 
PLoS ONE  2014;9(3):e90103.
Objectives
To evaluate the effect of a practice-based, culturally appropriate patient education intervention on blood pressure (BP) and treatment adherence among patients of African origin with uncontrolled hypertension.
Methods
Cluster randomised trial involving four Dutch primary care centres and 146 patients (intervention n = 75, control n = 71), who met the following inclusion criteria: self-identified Surinamese or Ghanaian; ≥20 years; treated for hypertension; SBP≥140 mmHg. All patients received usual hypertension care. The intervention-group was also offered three nurse-led, culturally appropriate hypertension education sessions. BP was assessed with Omron 705-IT and treatment adherence with lifestyle- and medication adherence scales.
Results
139 patients (95%) completed the study (intervention n = 71, control n = 68). Baseline characteristics were largely similar for both groups. At six months, we observed a SBP reduction of ≥10 mmHg -primary outcome- in 48% of the intervention group and 43% of the control group. When adjusted for pre-specified covariates age, sex, hypertension duration, education, baseline measurement and clustering effect, the between-group difference was not significant (OR; 0.42; 95% CI: 0.11 to 1.54; P = 0.19). At six months, the mean SBP/DBD had dropped by 10/5.7 (SD 14.3/9.2)mmHg in the intervention group and by 6.3/1.7 (SD 13.4/8.6)mmHg in the control group. After adjustment, between-group differences in SBP and DBP reduction were −1.69 mmHg (95% CI: −6.01 to 2.62, P = 0.44) and −3.01 mmHg (−5.73 to −0.30, P = 0.03) in favour of the intervention group. Mean scores for adherence to lifestyle recommendations increased in the intervention group, but decreased in the control group. Mean medication adherence scores improved slightly in both groups. After adjustment, the between-group difference for adherence to lifestyle recommendations was 0.34 (0.12 to 0.55; P = 0.003). For medication adherence it was −0.09 (−0.65 to 0.46; P = 0.74).
Conclusion
This intervention led to significant improvements in DBP and adherence to lifestyle recommendations, supporting the need for culturally appropriate hypertension care.
Trial Registration
Controlled-Trials.com ISRCTN35675524
doi:10.1371/journal.pone.0090103
PMCID: PMC3943841  PMID: 24598584
19.  Impact of preoperative patient education on prevention of postoperative complications after major visceral surgery: study protocol for a randomized controlled trial (PEDUCAT trial) 
Trials  2013;14:271.
Background
In line with the growing number of surgical procedures being performed worldwide, postoperative complications are also increasing proportionately. Prevention of these postoperative complications is a high medical priority. Preoperative education of patients, including provision of preparatory information about the correct behavior after surgery, could improve the postoperative outcome, but the evidence for this is inconclusive. The aim of the PEDUCAT trial is to evaluate the feasibility and the impact of preoperative patient education on postoperative morbidity, mortality and quality of life in patients scheduled for elective major visceral surgery.
Methods/design
PEDUCAT is designed as a cluster-randomized controlled pilot study. The experimental group will visit a standardized preoperative seminar to learn how best to behave after surgery in addition to being given a standard information brochure, whereas the control group will only receive the information brochure. Outcome measures such as postoperative morbidity, postoperative pain, postoperative anxiety and depression, patient satisfaction, quality of life, length of hospital stay and postoperative mortality will be evaluated. Statistical analysis will be based on the intention-to-treat population. Analysis of covariance will be applied for the intervention group comparison, adjusting for age, center and quality of life before surgery. This is a pilot study to show the feasibility of the concept. Nevertheless, the planned sample size of n = 204 is large enough to show an effect with power of 90% and a significance level of 5%.
Trial registration
German Clinical Trial Register number: DRKS00004226.
doi:10.1186/1745-6215-14-271
PMCID: PMC3765330  PMID: 23978275
Patient education; Preoperative education; Postoperative complication; Prevention; Visceral surgery; Cluster randomization
20.  Using a Computer to Teach Patients about Fecal Occult Blood Screening 
OBJECTIVE
To determine whether a multimedia computer program could effectively teach patients about fecal occult blood testing (FOBT) and increase screening rates.
DESIGN
Randomized trial.
SETTING
University-affiliated, community-based Internal Medicine outpatient practice.
PARTICIPANTS
All English-speaking patients aged 50 years and older who were offered FOBT screening by their providers were invited to participate. Two hundred and four patients enrolled in the study. Ten patients were later determined to be ineligible.
INTERVENTIONS
Patients were randomized to either the educational multimedia computer program or usual nurse counseling about FOBT screening. Screening instructions were based on the material pre-printed on each test kit. Educational sessions were held in a private setting immediately after each patient's office visit.
MEASUREMENTS AND MAIN RESULTS
A knowledge-assessment questionnaire was administered in a blinded fashion by telephone the following day. Successful screening was defined as return of the test kits within 30 d. Completion of the FOBT kits was similar in both groups: 62% (58/93) in the computer group and 63% (64/101) in the nurse group (P=.89). Mean knowledge scores were also similar, but there was a trend toward increased knowledge mastery in the computer group (56% vs 41%, P=.09).
CONCLUSIONS
A multimedia educational computer program was as effective as usual nurse counseling in educating patients and achieving adherence to FOBT screening. Future studies are needed to determine whether computer-assisted instruction can improve health outcomes.
doi:10.1111/j.1525-1497.2005.0081.x
PMCID: PMC1490260  PMID: 16307621
computer-assisted instruction; colorectal neoplasms; mass screening; patient education; occult blood
21.  Impact of percutaneous coronary intervention on biomarker levels in patients in the subacute phase following myocardial infarction: the Occluded Artery Trial (OAT) biomarker ancillary study 
Background
The purpose of the Occluded Artery Trial (OAT) Biomarker substudy was to evaluate the impact of infarct related artery (IRA) revascularization on serial levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and dynamics of other biomarkers related to left ventricular remodeling, fibrosis and angiogenesis.
Methods
Patients were eligible for OAT-Biomarker based on the main OAT criteria. Of 70 patients (age 60.8 ± 8.8, 25% women) enrolled in the substudy, 37 were randomized to percutaneous coronary intervention (PCI) and 33 to optimal medical therapy alone. Baseline serum samples were obtained prior to OAT randomization with follow up samples taken at one year. The primary outcome was percent change of NT-proBNP from baseline to 1 year. The secondary outcomes were respective changes of matrix metalloproteinases (MMP) 2 and 9, tissue inhibitor of matrix metalloproteinase 2 (TIMP-2), Vascular Endothelial Growth Factor (VEGF), and Galectin-3.
Results
Paired (baseline and one-year) serum samples were obtained in 62 subjects. Baseline median NT-proBNP level was 944.8 (455.3, 1533) ng/L and decreased by 69% during follow-up (p < 0.0001). Baseline MMP-2 and TIMP-2 levels increased significantly from baseline to follow-up (p = 0.034, and p = 0.027 respectively), while MMP-9 level decreased from baseline (p = 0.038). Levels of VEGF and Galectin-3 remained stable at one year (p = NS for both). No impact of IRA revascularization on any biomarker dynamics were noted.
Conclusions
There were significant changes in measured biomarkers related to LV remodeling, stress, and fibrosis following MI between 0 and 12 month. Establishing infarct vessel patency utilizing stenting 24 hours-28 days post MI did not however influence the biomarkers’ release.
doi:10.1186/1471-2261-13-91
PMCID: PMC3871016  PMID: 24156746
Acute coronary syndrome; Percutaneous coronary intervention; Biomarkers; Heart failure; Remodeling
22.  Impact of National Clinical Guideline Recommendations for Revascularization of Persistently Occluded Infarct-Related Arteries on Clinical Practice in the United States 
Archives of internal medicine  2011;171(18):1636-1643.
Background
The Occluded Artery Trial (OAT) was a large, randomized controlled trial published in 2006 that demonstrated no benefit to routine percutaneous coronary intervention (PCI) of persistently totally occluded infarct-related arteries (IRA) identified a minimum of 24 hours (on calendar days 3–28) after myocardial infarction (MI). The purpose of this study was to determine the impact of OAT results and consequent change in guideline recommendations for PCI for treatment of persistently occluded IRAs.
Methods
We identified all patients enrolled in the CathPCI Registry, from 2005 to 2008, undergoing catheterization more than 24 hours after MI with a totally occluded native coronary artery and no major OAT exclusion criteria. We examined trends in monthly rates of PCI for occlusions after OAT publication and after guideline revisions. Because reporting of diagnostic catheterizations was not mandatory, we examined trends among hospitals in the highest quartile for reporting of diagnostic procedures.
Results
A total of 28 780 patient visits from 896 hospitals were included. Overall, we found no significant decline in the adjusted monthly rate of PCI of occlusions after publication of OAT (odds ratio [OR], 0.997; 95% confidence interval [CI], 0.989–1.006) or after guideline revisions (OR, 1.007; 95% CI, 0.992–1.022). Among hospitals consistently reporting diagnostic catheterizations, there was no significant decline after OAT publication (OR, 1.018; 95% CI, 0.995–1.042), and there was a trend toward decline after guideline revisions (OR, 0.963; 95% CI, 0.920–1.000).
Conclusion
These findings suggest that the results of OAT and consequent guideline revisions have not, to date, been fully incorporated into clinical practice in a large cross-section of hospitals in the United States.
doi:10.1001/archinternmed.2011.315
PMCID: PMC3738051  PMID: 21747002
23.  Reducing Adverse Self-Medication Behaviors in Older Adults with Hypertension: Results of an e-health Clinical Efficacy Trial 
Ageing international  2011;36(2):159-191.
A randomized controlled efficacy trial targeting older adults with hypertension (age 60 and over) provided an e-health, tailored intervention with the “next generation” of the Personal Education Program (PEP-NG). Eleven primary care practices with advanced practice registered nurse (APRN) providers participated. Participants (N=160) were randomly assigned by the PEP-NG (accessed via a wireless touchscreen tablet computer) to either control (entailing data collection and four routine APRN visits) or tailored intervention (involving PEP-NG intervention and four focused APRN visits) group. Compared to patients in the control group, patients receiving the PEP-NG e-health intervention achieved significant increases in both self-medication knowledge and self-efficacy measures, with large effect sizes. Among patients not at BP targets upon entry to the study, therapy intensification in controls (increased antihypertensive dose and/or an additional antihypertensive) was significant (p=.001) with an odds ratio of 21.27 in the control compared to the intervention group. Among patients not at BP targets on visit 1, there was a significant declining linear trend in proportion of the intervention group taking NSAIDs 21–31 days/month (p=0.008). Satisfaction with the PEP-NG and the APRN provider relationship was high in both groups. These results suggest that the PEP-NG e-health intervention in primary care practices is effective in increasing knowledge and self-efficacy, as well as improving behavior regarding adverse self-medication practices among older adults with hypertension.
doi:10.1007/s12126-010-9085-9
PMCID: PMC3092917  PMID: 21654869
Hypertension; Self-medication management; Older adults; Tailored intervention; e-health
24.  Reducing Adverse Self-Medication Behaviors in Older Adults with Hypertension: Results of an e-health Clinical Efficacy Trial 
Ageing International  2010;36(2):159-191.
A randomized controlled efficacy trial targeting older adults with hypertension (age 60 and over) provided an e-health, tailored intervention with the “next generation” of the Personal Education Program (PEP-NG). Eleven primary care practices with advanced practice registered nurse (APRN) providers participated. Participants (N = 160) were randomly assigned by the PEP-NG (accessed via a wireless touchscreen tablet computer) to either control (entailing data collection and four routine APRN visits) or tailored intervention (involving PEP-NG intervention and four focused APRN visits) group. Compared to patients in the control group, patients receiving the PEP-NG e-health intervention achieved significant increases in both self-medication knowledge and self-efficacy measures, with large effect sizes. Among patients not at BP targets upon entry to the study, therapy intensification in controls (increased antihypertensive dose and/or an additional antihypertensive) was significant (p = .001) with an odds ratio of 21.27 in the control compared to the intervention group. Among patients not at BP targets on visit 1, there was a significant declining linear trend in proportion of the intervention group taking NSAIDs 21–31 days/month (p = 0.008). Satisfaction with the PEP-NG and the APRN provider relationship was high in both groups. These results suggest that the PEP-NG e-health intervention in primary care practices is effective in increasing knowledge and self-efficacy, as well as improving behavior regarding adverse self-medication practices among older adults with hypertension.
doi:10.1007/s12126-010-9085-9
PMCID: PMC3092917  PMID: 21654869
Hypertension; Self-medication management; Older adults; Tailored intervention; e-health
25.  Coeliac disease and oats: a systematic review 
Postgraduate Medical Journal  2006;82(972):672-678.
A systematic review of the literature related to the inclusion of oats in the gluten‐free diet for patients with coeliac disease to assess whether oats can be recommended. A computerised literature review of multiple databases was carried out, identifying 17 primary studies, 6 of which met the criteria for inclusion in this review. None of the six studies found any significant difference in the serology between the oats and control groups. Two studies, however, identified a significant difference (p<0.001; p = 0.039) in intraepithelial lymphocyte counts between the oats and control groups. Oats can be symptomatically tolerated by most patients with coeliac disease; however, the long‐term effects of a diet containing oats remain unknown. Patients with coeliac disease wishing to consume a diet containing oats should therefore receive regular follow‐up, including small bowel biopsy at a specialist clinic for life.
doi:10.1136/pgmj.2006.045443
PMCID: PMC2653911  PMID: 17068278
oats; coeliac disease; gluten free diet; dermatitis herpetiformis; avenin

Results 1-25 (920171)