Implementing Black Box Warnings (BBWs) in Health Information Systems: An Organizing Taxonomy Identifying Opportunities and Challenges

Objective

To develop a practical approach for implementing clinical decision support (CDS) for medication black box warnings (BBWs) into health information systems (HIS).

Methods

We reviewed all existing medication BBWs and organized them into a taxonomy that identifies opportunities and challenges for implementing CDS for BBWs into HIS.

Results

Of the over 400 BBWs that currently exist, they can be organized into 4 categories with 9 sub-categories based on the types of information contained in the BBWs, who should be notified, and potential actions to that could be taken by the person receiving the BBW. Informatics oriented categories and sub-categories of BBWs include – interactions (13%) (drug-drug (4%) and drug-diagnosis (9%)), testing (21%) (baseline (9%) and on-going (12%)), notifications (29%) (drug prescribers (7%), drug dispensers (2%), drug administrators (9%), patients (10%), and third parties (1%)), and non-actionable (37%). This categorization helps identify BBWs for which CDS can be easily implemented into HIS today (such as drug-drug interaction BBWs), those that cannot be easily implemented into HIS today (such as non-actionable BBWs), and those where advanced and/or integrated HIS need to be in place to implement CDS for BBWs (such a drug dispensers BBWs).

Conclusions

HIS have the potential to improve patient safety by implementing CDS for BBWs. A key to building CDS for BBWs into HIS is developing a taxonomy to serve as an organizing roadmap for implementation. The informatics oriented BBWs taxonomy presented here identified types of BBWs in which CDS can be implemented easily into HIS currently (a minority of the BBWs) and those types of BBWs where CDS cannot be easily implemented today (a majority of BBWs).     

Family practice patients' use of acetylsalicylic acid for cardiovascular disease prevention

Objective

To determine the prevalence of acetylsalicylic acid (ASA) use among family practice patients and the proportions of patients using ASA for primary and secondary cardiovascular prevention.

Design

Cross-sectional, self-reported, waiting room questionnaire.

Setting

Two family medicine clinics in Alberta.

Participants

Patients 50 years of age and older.

Main outcome measures

Overall prevalence of ASA use, proportion of ASA use for primary or secondary cardiovascular prevention, ASA use by patient age and sex, the proportion of patients who initiated ASA therapy on the advice of a physician, adverse events, and patient beliefs about ASA therapy.

Results

A total of 807 patients completed the questionnaire; the response rate was 89.1%. Overall, 39.8% of patients reported taking ASA regularly. Of those who took ASA, 87.0% did so for cardiovascular prevention (53.1% for primary prevention and 46.9% for secondary prevention). Of patients taking ASA for primary prevention, 62.8% did so upon the advice of their family physicians. Patients who took ASA believed that the benefits of taking ASA outweighed the risks; those who did not take ASA were unsure of the benefit-to-risk profile.

Conclusion

Many family practice patients take ASA, and more than half of those taking ASA take it for primary cardiovascular prevention. Family physicians appear to have an influence on patients'' decisions to take ASA. Educating family physicians and patients about the potential benefits and risks of ASA therapy would help promote the use of ASA in those who might receive the greatest overall benefit.     

Deep vein thrombosis among injecting drug users in Sheffield

Aims

To identify the proportion of patients testing positive for deep vein thrombosis (DVT) who are injecting drug users (IDUs), and examine differences in the investigation and management of this group compared with non‐IDUs.

Methods

Analysis of data collected from emergency department records and a review of patient notes.

Results

All patients in this study who were known to inject recreational drugs tested positive for DVT on Doppler ultrasound scan.

Conclusions

IDUs should be considered at high risk of developing DVT and should be investigated accordingly.To identify the proportion of patients testing positive for deep vein thrombosis (DVT) who are injecting drug users (IDUs).To establish if the IDUs are managed as inpatients more or less often than their non‐IDU counterparts.To highlight any differences in the medical management of patients with confirmed DVT in each group (IDUs and non‐IDUs).     

Patients’ awareness of the surgical risks of smoking: Implications for supporting smoking cessation

Objective

To describe the smoking patterns of patients receiving elective surgery and their knowledge about the benefits of smoking cessation to inform and strengthen support for patients to quit smoking in order to optimize surgical outcomes.

Design

Patients who had elective surgery were screened for smoking status, and eligible patients completed a telephone survey.

Setting

Two regional hospitals in northern British Columbia.

Participants

Of 1722 patients screened, 373 reported smoking before surgery. Of these, 161 (59.0% women) completed a telephone survey.

Main outcome measures

Patient smoking cessation, knowledge of the perioperative risks of smoking, use of resources, and health care provider advice and assistance.

Results

Participants included 66 men and 95 women (mean [SD] age of 51.9 [14.0] years). In total, 7.5% of these patients quit smoking in the 8 weeks before their surgeries, although an additional 38.8% reduced their smoking. Only about half of the patients surveyed were aware that continuing to smoke increased their surgical risks. Further, only half of the patients surveyed reported being advised to quit before their surgeries by a health care professional. Few were using the provincial resources available to support smoking cessation (eg, QuitNow), and 39.6% were unaware of the provincial program to cover the cost of smoking cessation aids (eg, nicotine gum or patches), yet 62.7% of respondents were thinking about quitting smoking.

Conclusion

Many surgical patients in northern British Columbia who smoked were unaware of the perioperative risks of smoking and the cessation support available to them. An opportunity exists for all health care professionals to encourage more patients to quit in order to optimize their surgical outcomes.     

Intensivists: don't quit your day job...yet!

Citation

Levy MM, Rapoport J, Lemeshow S, Chalfin DB, Phillips G, and Danis M: Association between Critical Care Physician Management and Patient Mortality in the Intensive Care Unit. Ann Intern Med 2008 Jun 3, 148(11): 801-9 [1].

Background

Critically ill patients admitted to intensive care units (ICUs) are thought to gain an added survival benefit from management by critical care physicians, but evidence of this benefit is scant.

Methods

Objective

To examine the association between hospital mortality in critically ill patients and management by critical care physicians.

Design

Retrospective analysis of a large, prospectively collected database of critically ill patients.

Setting

123 ICUs in 100 U.S. hospitals.

Subjects

101,832 critically ill adults.

Intervention

None.

Outcomes

Through use of a random-effects logistic regression, investigators compared hospital mortality between patients cared for entirely by critical care physicians and patients cared for entirely by non-critical care physicians. An expanded Simplified Acute Physiology Score was used to adjust for severity of illness, and a propensity score was used to adjust for differences in the probability of selective referral of patients to critical care physicians.

Results

Patients who received critical care management (CCM) were generally sicker, received more procedures, and had higher hospital mortality rates than those who did not receive CCM. After adjustment for severity of illness and propensity score, hospital mortality rates were higher for patients who received CCM than for those who did not. The difference in adjusted hospital mortality rates was less for patients who were sicker and who were predicted by propensity score to receive CCM. Residual confounders for illness severity and selection biases for CCM might exist that were inadequately assessed or recognized.

Conclusion

In a large sample of ICU patients in the United States, the odds of hospital mortality were higher for patients managed by critical care physicians than those who were not. Additional studies are needed to further evaluate these results and clarify the mechanisms by which they might occur.     

REHABILITATION AFTER HIP ARTHROSCOPY AND LABRAL REPAIR IN A HIGH SCHOOL FOOTBALL ATHLETE

Study Design:

Case Report

Background:

Femoral acetabular impingement (FAI) has been implicated in the etiology of acetabular labral tears. The rehabilitation of younger athletes following arthroscopic surgery for FAI and labral tears is often complex and multifactorial. A paucity of evidence exists to describe the rehabilitation of younger athletes who have undergone arthroscopic hip surgery.

Case Presentation:

This case report describes a four-phase rehabilitation program for a high school football player who underwent hip arthroscopy with a labral repair and chondroplasty.

Outcomes:

The player returned to training for football 16 weeks later and at the 4 month follow-up was pain free with no signs of FAI.

Discussion:

There is little evidence regarding the rehabilitation of younger athletes who undergo arthroscopic hip surgery. This case study described a four phase rehabilitation program for a high school football player who underwent hip arthroscopy and labral repair. The patient achieved positive outcomes with a full return to athletic activity and football. The overall success of these patients depends on the appropriate surgical procedure and rehabilitation program.

Key Words:

Femoral acetabular impingement (FAI), hip, hip impingement

Level of evidence:

4-Case report     

How infectious disease outbreaks affect community-based primary care physicians: Comparing the SARS and H1N1 epidemics

Objective

To compare how the infectious disease outbreaks H1N1 and severe acute respiratory syndrome (SARS) affected community-based GPs and FPs.

Design

A mailed survey sent after the H1N1 outbreak compared with the results of similar survey completed after the SARS outbreak.

Setting

Greater Toronto area in Ontario.

Participants

A total of 183 randomly selected GPs and FPs who provided office-based care.

Main outcome measures

The perceptions of GPs and FPs on how serious infectious disease outbreaks affected their clinical work and personal lives; their preparedness for a serious infectious disease outbreak; and the types of information they want to receive and the sources they wanted to receive information from during a serious infectious disease outbreak. The responses from this survey were compared with the responses of GPs and FPs in the greater Toronto area who completed a similar survey in 2003 after the SARS outbreak.

Results

After the H1N1 outbreak, GPs and FPs still had substantial concerns about the effects of serious infectious disease outbreaks on the health of their family members. Physicians made changes to various office practices in order to manage and deal with patients with serious infectious diseases. They expressed concerns about the effects of an infectious disease on the provision of health care services. Also, physicians wanted to quickly receive accurate information from the provincial government and their medical associations.

Conclusion

Serious community-based infectious diseases are a personal concern for GPs and FPs, and have considerable effects on their clinical practice. Further work examining the timely flow of relevant information through different health care sectors and government agencies still needs to be undertaken.     

PREVALENCE OF MUSCULOSKELETAL PAIN IN MARATHON RUNNERS WHO COMPETE AT THE ELITE LEVEL

Background

Musculoskeletal pain can be an important sign of overuse injury in elite athletes. However, its prevalence and whether it is associated with aspects of training in marathon runners who compete at the elite level is still not clear.

Purpose

The purpose of this research was to assess the prevalence, location and intensity of running-related musculoskeletal pain over the previous 12 months in marathon runners who compete at the elite level and to verify whether certain training characteristics are associated with musculoskeletal pain.

Design

Cross sectional study.

Methods

One hundred and ninety-nine elite marathon runners were verbally interviewed regarding their personal demographics, training routines, and the presence, location and intensity of musculoskeletal pain.

Results

The prevalence of any running-related musculoskeletal pain in elite distance runners was 75%, and the most frequently reported location was the lower leg (19.1%). The presence of pain was independent of age, experience, and volume of training.

Conclusions

Running-related musculoskeletal pain is highly prevalent in marathon runners who compete at the elite level.

Clinical Relevance

Studies about prevalence and location of musculoskeletal pain and factors-related in this population are important to contribute to the development of educational and preventive strategies.

Evidence Level

2     

Incidence of narcotic abuse during pregnancy in northwestern Ontario: Three-year prospective cohort study

Objective

To document the incidence and outcomes of narcotic use during pregnancy in northwestern Ontario.

Design

Three-year prospective cohort study.

Setting

Sioux Lookout and surrounding communities in northwestern Ontario.

Participants

A total of 1206 consecutive births in a catchment area of 28 000 First Nations patients.

Main outcome measures

Incidence of narcotic use, and maternal and neonatal outcomes.

Results

Incidence of narcotic use in pregnancy has risen to 28.6% (P < .001) and incidence of neonatal abstinence syndrome has fallen to 18.0% of narcotic-exposed births (P = .003). Daily intravenous drug use is now a common pattern of abuse.

Conclusion

Narcotic abuse in pregnancy has dramatically increased in northwestern Ontario. Neonatal outcomes have improved as a result of a family medicine–based prenatal and obstetric program that includes a narcotic replacement and tapering program.     

Black Hawk Down: The evolution of resuscitation strategies in massive traumatic hemorrhage

Citation

Borgman MA, Spinella PC, Perkins JG, Grathwohl KW, Repine T, Beekley AC, Sebesta J, Jenkins D, Wade CE, Holcomb JB: The ratio of blood products transfused affects mortality in patients receiving massive transfusions at a combat support hospital. J Trauma 2007, 63: 805–813 [1].

Background

Patients with severe traumatic injuries often present with coagulopathy and require massive transfusion. The risk of death from hemorrhagic shock increases in this population. To treat the coagulopathy of trauma, some have suggested early, aggressive correction using a 1:1 ratio of plasma to red blood cell (RBC) units.

Methods

Objective

To determine whether the ratio of plasma to RBCs transfused would affect survival by decreasing death from hemorrhage.

Design

Retrospective chart review.

Setting

United States Army combat support hospital in Iraq.

Subjects

246 patients who received a massive transfusion (≥10 units of RBCs in 24 hours) from November 2003 to September 2005. Three groups of patients were constructed according to the plasma to RBC ratio transfused during massive transfusion.

Intervention

None.

Outcome

Hospital mortality rates and the cause of death were compared among groups. Multivariable logistic regression was used to determine the independent association between plasma to RBC ratio and hospital mortality.

Results

For the low ratio group the plasma to RBC median ratio was 1:8 (interquartile range (IQR), 0:12–1:5), for the medium ratio group, 1:2.5 (IQR, 1:3.0–1:2.3), and for the high ratio group, 1:1.4 (IQR, 1:1.7–1:1.2) (p < 0.001). Median Injury Severity Score (ISS) was 18 for all groups (IQR, 14–25). For low, medium, and high plasma to RBC ratios, overall mortality rates were 65%, 34%, and 19%, (p < 0.001); and hemorrhage mortality rates were 92.5%, 78%, and 37%, respectively (p < 0.001). Upon logistic regression, plasma to RBC ratio was independently associated with survival (odds ratio 8.6, 95% confidence interval 2.1–35.2).

Conclusion

In patients with combat-related trauma requiring massive transfusion, a high 1:1.4 plasma to RBC ratio is independently associated with improved survival to hospital discharge, primarily by decreasing death from hemorrhage. For practical purposes, massive transfusion protocols should utilize a 1:1 ratio of plasma to RBCs for all patients who are hypocoagulable with traumatic injuries.     

Sociodemographic factors associated with cervical cancer screening and follow-up of abnormal results

Objective

To determine the sociodemographic factors associated with cervical cancer screening and follow-up of abnormal results.

Design

Population cohort study.

Setting

Ontario.

Participants

Women between the ages of 18 and 70 years who were eligible for Papanicolaou testing.

Main outcome measures

Rates of cervical cancer screening and follow-up of abnormal and inadequate Pap test results, and associated sociodemographic factors such as age, neighbourhood income level, and health region. Multivariate logistic regression was used to identify independent factors associated with screening and follow-up.

Results

Of the 3.7 million women eligible for screening, 69% had had Pap tests in the past 3 years. These rates varied by age, income, and region (P < .001). Women residing in the lowest-income neighbourhoods were half as likely to be screened (odds ratio 0.56, 95% CI 0.55 to 0.56). Only 44% of those whose Pap test results revealed atypical squamous cells of uncertain significance or low-grade squamous intraepithelial lesions had repeat Pap tests or colposcopy within 6 months, and this varied by age, income, and region (P < .001). Among women with unsatisfactory Pap test results, only 35% were retested within 4 months, and this varied by age (P < .001).

Conclusion

Despite universal health coverage, cervical cancer screening rates are suboptimal among low-income women at greatest risk. Follow-up among women with inadequate or abnormal test results is often poor. Novel models of cervical cancer screening are needed to address these inadequacies.     

Survivorship care in breast cancer: Perceptions of patients and primary care physicians

Objective

To compare the perceptions of breast cancer survivors and primary care physicians (PCPs) about PCPs’ ability to deliver survivorship care in breast cancer.

Design

Mailed survey.

Setting

British Columbia.

Participants

A total of 1065 breast cancer survivors who had completed treatment of nonmetastatic breast cancer within the previous year, and 587 PCPs who had patients with nonmetastatic breast cancer discharged to their care within the preceding 18 months.

Main outcome measures

Breast cancer survivors’ and PCPs’ confidence ratings of PCPs’ ability to deliver the following aspects of care: screening for recurrence; managing osteoporosis, lymphedema, endocrine therapy, menopausal symptoms, and anxiety about or fear of recurrence; and providing nutrition and exercise counseling, sex and body image counseling, and family counseling. Response options for each question included low, adequate, or good. Responses were summarized as frequencies and compared using χ² tests.

Results

Response rates for breast cancer survivors and PCPs were 47% and 59%, respectively. Responses were statistically different in all categories (P < .05). Both groups were most confident in the ability of PCPs to screen for recurrence, but breast cancer survivors were 10 times as likely to indicate low confidence (10% of breast cancer survivors vs 1% of PCPs) in this aspect of care. More breast cancer survivors (23%) expressed low confidence in PCPs’ ability to provide counseling about fear of recurrence compared with PCPs (3%). Aspects of care in which both breast cancer survivors and PCPs were most likely to express low confidence included sex and body image counseling (35% of breast cancer survivors vs 26% of PCPs) and family counseling (33% of breast cancer survivors vs 24% of PCPs). Primary care physicians (24%) described low confidence in their ability to manage lymphedema.

Conclusion

Breast cancer survivors and PCPs are reasonably confident in a PCP-based model of survivorship care. Primary care physicians are confident in their ability to manage physical effects related to breast cancer, with the exception of lymphedema. Low confidence ratings among both groups in psychosocial aspects of care suggest an area for improvement.     

Recording blood pressure readings in elderly patients’ charts: What patient and physician characteristics make it more likely?

OBJECTIVE

To identify patient and physician characteristics associated with family physicians recording blood pressure (BP) measurements in the medical charts of their elderly patients.

DESIGN

Retrospective review of patients’ charts during a 12-month period and baseline questionnaire on the sociodemographic and practice characteristics of family physicians participating in the Community Hypertension Assessment Trial. The chart review collected data on patients’ demographics, cardiovascular risk factors, antihypertensive medications, number of visits to family physicians, and number of BP readings recorded.

SETTING

Non-academic family practices in Hamilton and Ottawa, Ont.

PARTICIPANTS

Data were abstracted from the charts of 55 randomly selected regular elderly patients (65 years old and older) from each of 28 participating family practices (N = 1540 charts).

MAIN OUTCOME MEASURE

Number of recordings of BP measurements in medical charts during a 12-month period.

RESULTS

About 16% (241/1540) of elderly patients had not had their BP recorded in their charts during the 12-month review period. Among this 16%, almost half (47%, 114/241) had not had a BP measurement recorded during the previous 24 months. Multivariate analysis indicated that the likelihood of BP recording increased with the number of visits made to family physicians and was greater among patients taking antihypertensive medications or diagnosed with hypertension. Physicians who had more recently graduated from medical school (≤ 24 years) were more likely to record BP measurements.

CONCLUSION

Hypertension guidelines recommend that, for patients at risk, BP be measured and recorded at each office visit. Although more than 84% of older patients had at least 1 BP reading documented in their charts, patients who were already diagnosed with hypertension or who made frequent visits to the office were more likely to have their BP measured and recorded. A more systematic approach to monitoring elderly patients who visit their family physicians less frequently or who are not currently diagnosed with hypertension is needed.     

Establishing physician advocates for human papillomavirus vaccination in British Columbia

Objective

To survey general practitioners in oncology (GPOs) in British Columbia (BC) to identify opportunities for them to serve as public supporters of human papillomavirus (HPV) vaccination.

Design

A mailed or online survey.

Setting

British Columbia.

Participants

Forty-two GPOs who worked in the community in BC.

Main outcome measures

Current practices, knowledge, and resource needs concerning HPV, the vaccine, and the HPV immunization program, and the willingness of respondents to be contacted to participate in stated public HPV vaccine supporter activities.

Results

The survey found that 42% of surveyed GPOs were willing to act as public supporters of the HPV vaccine. The survey also identified education needs among GPOs concerning HPV, the vaccine, and the HPV immunization program in BC.

Conclusion

This study found that GPOs in BC are willing to publicly support the HPV immunization program. This study shows that involving physicians in the promotion of public health programs is a viable option that should be further explored and evaluated.