Real-time clinical alerting: effect of an automated paging system on response time to critical laboratory values--a randomised controlled trial.

BACKGROUND: Timely and reliable communication of critical laboratory values is a Joint Commission National Patient Safety Goal. The objective was to evaluate the effect of an automated system for paging critical values directly to the responsible physician. METHODS: A randomised controlled trial on the general medicine clinical teaching units at an urban academic hospital was conducted from February to May 2006; the unit of randomisation was the critical laboratory value. The intervention was an automated paging system that sent the critical value directly to the responsible physician's pager. The control arm was usual care, which was a telephone call to the patient's ward by the laboratory technician. The primary outcome was response time, defined as the interval between acceptance of the critical value into the laboratory information system to the writing of an order on the patient's chart in response to the critical value. If the time of order was not documented, the time of administration of treatment was used to calculate response time. RESULTS: For primary analysis, 165 critical values were evaluated on 108 patients with full response time data. The median response time was 16 min (IQR 2-141) for the automated paging group and 39.5 min (IQR 7-104.5) for the usual care group (p=0.33). CONCLUSIONS: The automated paging system reduced the length of time physicians took to respond to critical laboratory values, but this difference was not statistically significant. Future reseach should evaluate the effects of alerts for conditions that currently do not generate a phone call and the addition of real-time decision support to the critical value alerts.

Implementation and evaluation of an alpha-numeric paging system on a resident inpatient teaching service.

BACKGROUND: Numeric pagers are commonly used communication devices in healthcare, but cannot convey important information such as the reason for or urgency of the page. Alphanumeric pagers can display both numbers and text, and may address some of these communication problems. OBJECTIVE: Our primary aim was to implement an alphanumeric paging system. DESIGN: Continuous quality improvement study using rapid-cycle change methods. SETTING: General Internal Medicine (GIM) inpatient wards at 1 tertiary care academic teaching hospital. PARTICIPANTS: All residents, attending physicians, nurses, and allied health staff working on the general medicine (GM) wards. MEASUREMENTS: We measured: (1) the proportion of pages sent as text pages, (2) the source of the pages, (3) the content of the text pages, (4) the pages that disrupted scheduled education activities, and (5) satisfaction with the alphanumeric paging system. RESULTS: After implementation, 52% of pages sent from physicians or the GM wards were sent as text pages (P < 0.001). 93% of pages between physicians were text pages, compared to 27% of pages from the GM wards to physicians (P < 0.001). The most common reason for text paging among physicians was to arrange work or teaching rounds (33%). The most common reason for text paging from the GM wards was to request a patient assessment or for notification of a patient's clinical status (25%). There was a 29% reduction in disruptive pages sent during scheduled educational rounds (P < 0.001). CONCLUSIONS: We successfully implemented an alphanumeric paging system that reduced disruptive pages on a GM inpatient service.

Reconcilable differences: correcting medication errors at hospital admission and discharge.

BACKGROUND: Medication errors at the time of hospital admission and discharge are common and can lead to preventable adverse drug events. The objective of this study was to describe the potential impact of a medication reconciliation process to identify and rectify medication errors at the time of hospital admission and discharge. METHODS: Sixty randomly selected patients were prospectively enrolled at the time of admission to a Canadian community hospital. At admission, patients' medication orders were compared with pre-admission medication use based on medication vials and interviews with patients, caregivers, and/or outpatient healthcare providers. At discharge, pre-admission and in-patient medications were compared with discharge orders and written instructions. All variances were discussed with the prescribing physician and classified as intended or unintended; unintended variances were considered to be medication errors. An internist classified the clinical importance of each unintended variance. RESULTS: Overall, 60% (95% CI 48 to 72) of patients had at least one unintended variance and 18% (95% CI 9 to 28) had at least one clinically important unintended variance. None of the variances had been detected by usual clinical practice before reconciliation was conducted. Of the 20 clinically important variances, 75% (95% CI 56 to 94) were intercepted by medication reconciliation before patients were harmed. DISCUSSION: Unintended medication variances at the time of hospital admission and discharge are common and clinically important. The medication reconciliation process identified and addressed most of these unintended variances before harm occurred. In this small study, medication reconciliation was a useful method for identifying and rectifying medication errors at times of transition. Reconciliation warrants broader evaluation.

Development of a standardized, comprehensive "ideal drug detail".

OBJECTIVES: To develop a standardized, comprehensive ideal drug detail for use in face-to-face education about individual drugs. METHODS: A random sample of 603 physicians and pharmacists was selected and stratified to include input from each of the following specialties: family practice, internal medicine, surgery, pediatrics, psychiatry, obstetrics/gynecology, geriatric medicine and clinical pharmacology. Thirty-one potential items were generated by the investigators from a preliminary survey of a local convenience sample of physicians and pharmacists. A modified Delphi consensus process was used in the large sample to determine which items should be included in the ideal drug detail. In each round of the Delphi process, respondents rated each item on a seven-point scale of importance and were then given feedback of the cumulative ratings for each item. Rounds were continued until consensus was obtained on all items. RESULTS: The response rate to the first round was 55.3%; 85.5% of these respondents responded to the second round. Response rates varied between specialties from 44% to 70%. Attempts to contact nonresponders to measure potential nonrespondent bias were unsuccessful. Consensus was obtained on 19 items after the first round, and on the remaining 12 items after the second round. Four items were dropped because they were unimportant. There was variation in modal response between specialties on eight items. CONCLUSIONS: Consensus was obtained among a sizable and interested sample of Canadian physicians and pharmacists on the items of information needed to prescribe a drug appropriately. Subsequent work will refine this list into a usable template to develop ideal drug details for specific drugs, to develop an assessment process to measure quality of information, and to assess the impact of this program on prescribing and patient outcomes.

Improving patient safety: just do it!

Clinicians must celebrate and study medical errors. The dark culture of blame must be replaced by a scholarly culture of safety. This commentary presents six cases that show what we can learn from errors. The first step to identifying and understanding patient safety problems is to develop a common language for discussing patient safety. Latent unsafe conditions are ongoing circumstances of daily practice that reduce the safety of patients. An error is the failure ofa planned action to be completed as intended (error of execution), or the use of a wrong plan to achieve an aim (error of planning). Errors can be intercepted by appropriate action that minimizes the threat to patient safety. An adverse event is any unintended result of medical treatment that results in prolonged hospital stay, morbidity or mortality. If an adverse event is caused by an error, or series of errors, then it is a preventable adverse event. The teaching hospital is the first place where students (physicians, nurses, pharmacists and all other disciplines) are exposed to the culture of healthcare. It is essential to expose students to a culture of safety early in their training. Clinicians can make safety an academically important activity. Clinicians will find it difficult to undertake major safety initiatives given the existing constraints on time and energy. Although clinicians can identify the safety problems,there must also be a commitment to understand safety problems and make improvements. It is strongly recommended that hospitals train, implement and support Patient Safety Consultation Teams.

Informed consent in surgical trials.

All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

Clinical examination for the detection of protective sensation in the feet of diabetic patients. International Cooperative Group for Clinical Examination Research.

OBJECTIVE: We compared the reproducibility and accuracy of conventional clinical examination of the diabetic foot to monofilament examination. We also sought to simplify the monofilament examination by reducing it to fewer touch points. METHODS: In a cross-sectional study at 10 centers in the United States, Canada, and Switzerland, general internists and residents performed a structured history and physical examination for neuropathy on the feet of diabetic patients. Independent examination by two observers included monofilament sensation, pinprick, vibration, position sense, and ankle reflexes. MAIN RESULTS: A total of 304 patients were examined by at least one practitioner, and 200 received duplicate examinations. Monofilament examination and ankle reflexes had the best reproducibility, with moderate agreement (kappa = 0.59); pinprick, position, and vibration sense had fair agreement (kappa = 0.28-0.36). No component of the history or physical examination, singly or in aggregate, was both sensitive and specific for identifying a patient with an abnormal monofilament examination. A simplified monofilament examination using only 4 sites per foot (total 8 sites) detected 90% of patients with an abnormal 16-site monofilament evaluation. CONCLUSIONS: Conventional clinical examination had low reproducibility and correlated poorly with monofilament examination for the identification of the at-risk patient. The Semmes-Weinstein monofilament examination, a reproducible, valid, and generalizable test of foot sensation, is recommended as the screening procedure of choice for examining diabetic feet.

The rational clinical examination. Does this patient have aortic regurgitation?

OBJECTIVE: To review evidence as to the precision and accuracy of clinical examination for aortic regurgitation (AR). METHODS: We conducted a structured MEDLINE search of English-language articles (January 1966-July 1997), manually reviewed all reference lists of potentially relevant articles, and contacted authors of relevant studies for additional information. Each study (n = 16) was independently reviewed by both authors and graded for methodological quality. RESULTS: Most studies assessed cardiologists as examiners. Cardiologists' precision for detecting diastolic murmurs was moderate using audiotapes (kappa = 0.51) and was good in the clinical setting (simple agreement, 94%). The most useful finding for ruling in AR is the presence of an early diastolic murmur (positive likelihood ratio [LR], 8.8-32.0 [95% confidence interval [CI], 2.8-32 to 16-63] for detecting mild or greater AR and 4.0-8.3 [95% CI, 2.5-6.9 to 6.2-11] for detecting moderate or greater AR) (2 grade A studies). The most useful finding for ruling out AR is the absence of early diastolic murmur (negative LR, 0.2-0.3 [95% CI, 0.1-0.3 to 0.2-0.4) for mild or greater AR and 0.1 [95% CI, 0.0-0.3] for moderate or greater AR) (2 grade A studies). Except for a test evaluating the response to transient arterial occlusion (positive LR, 8.4 [95% CI, 1.3-81.0]; negative LR, 0.3 [95% CI, 0.1-0.8]), most signs display poor sensitivity and specificity for AR. CONCLUSION: Clinical examination by cardiologists is accurate for detecting AR, but not enough is known about the examinations of less-expert clinicians.

Economic analysis of low-dose heparin vs the low-molecular-weight heparin enoxaparin for prevention of venous thromboembolism after colorectal surgery.

BACKGROUND: Low-dose heparin and low-molecular-weight heparin are effective strategies for preventing venous thromboembolism in colorectal surgery. The economic attractiveness of these 2 strategies in North America is unknown. We conducted an economic analysis of low-dose heparin calcium compared with enoxaparin sodium, a low-molecular-weight heparin, for thromboembolism prophylaxis after colorectal surgery. METHODS: We used decision analysis, with an economic perspective of a third-party payer. Efficacy data were obtained from the Canadian Multicentre Colorectal Deep Vein Thrombosis Prophylaxis Trial and a literature review. Canadian costs for diagnosis and treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and major bleeding were obtained from chart review and a national hospital database of colorectal surgery; American costs were obtained from published literature. The main outcomes were incremental benefits (symptomatic DVTs, symptomatic PEs, and major bleeding events avoided) and incremental costs for every 1000 patients treated. RESULTS: In the Canadian Colorectal Trial, the relative risk of DVT and PE for enoxaparin compared with low-dose heparin was 1.0 (95% confidence interval, 0.7-1.5), and the relative risk of major bleeding was 1.8 (95% confidence interval, 0.8-3.9). With the use of these data in the baseline analysis, a strategy of enoxaparin prophylaxis was associated with equal numbers of symptomatic DVTs and PEs, and an excess of 12 major bleeding episodes for every 1000 patients treated, with an additional cost of $86 050 (Canadian data) or $145 667 (US data). In a sensitivity analysis using optimal assumptions for efficacy and safety of enoxaparin (relative risk of DVT, 0.8; relative risk of PE, 0.4; relative risk of major bleeding, 1.0), a strategy of enoxaparin prophylaxis was associated with 0.8 fewer symptomatic DVT, 3 fewer symptomatic PEs, and equal numbers of major bleeding episodes for every 1000 patients treated, with an additional cost of $15 217 (Canadian data) or $107 614 (US data). CONCLUSION: Although heparin and enoxaparin are equally effective, low-dose heparin is a more economically attractive choice for thromboembolism prophylaxis after colorectal surgery.

Agreement in assessing glaucomatous discs in a clinical teaching setting with stereoscopic disc photographs, planimetry, and laser scanning tomography.

PURPOSE: Agreement between three observers--two recently trained fellows and their supervisor--was measured using estimations of cup/disc ratio from stereoscopic optic nerve head photographs and planimetric measurements of cup/disc ratio. Agreement between the clinicians' planimetric measurements of cup/disc ratio and laser scanning tomographic measurements of cup/disc ratio also was assessed. METHODS: From 16 stereoscopic optic nerve head photographs of 16 subjects, the three observers performed clinical estimations of horizontal and vertical cup/disc ratios and planimetric measurements of cup/disc ratios. Interobserver agreement was measured using intraclass correlation coefficients (ICCs). Agreement between the planimetric cup/disc ratios and laser scanning tomographic cup/disc ratios obtained with the Heidelberg Retina Tomograph (HRT; Heidelberg Engineering, Heidelberg, Germany) also was measured using ICCs. The difference between the planimetric and HRT cup/disc ratios was calculated. RESULTS: The agreement between observers for clinical estimations from stereoscopic optic nerve head photographs (ICC = 0.74 horizontally and 0.83 vertically) was substantial. Agreement between the observers' planimetric measurements of cup/disc ratio was substantial (ICC = 0.79). Agreement between HRT cup/disc ratio and each observer's planimetric cup/disc ratio was moderate (ICC = 0.57-0.65), with large confidence intervals. The cup/disc ratio measured with HRT was an average of 0.07 to 0.11 larger than the planimetric cup/disc ratio. CONCLUSION: Substantial agreement between observers can be achieved when estimating cup/disc ratio with stereoscopic optic nerve head photographs and with planimetric measurements of cup/disc ratios, provided there is a standard protocol and sufficient training period. Good agreement is critical in a teaching institution to ensure accurate follow-up care of patients with glaucoma, especially if patients are examined by different clinicians. Laser scanning tomography is a more repeatable and objective method, which may provide further standardization of optic nerve head assessments. Future studies will determine the reference plane that optimizes agreement between the HRT findings and each clinician's estimations.

Assessment of patient capacity to consent to treatment.

OBJECTIVE: To compare results of a specific capacity assessment administered by the treating clinician, and a Standardized Mini-Mental Status Examination (SMMSE), with the results of expert assessments of patient capacity to consent to treatment. DESIGN: Cross-sectional study with independent comparison to expert capacity assessments. SETTING: Inpatient medical wards at an academic secondary and tertiary referral hospital. PARTICIPANTS: One hundred consecutive inpatients facing a decision about a major medical treatment or an invasive medical procedure. Participants either were refusing treatment, or were accepting treatment but were not clearly capable according to the treating clinician. MEASUREMENTS AND MAIN RESULTS: The treating clinician (medical resident or student) conducted a specific capacity assessment on each participant, using a decisional aid called the Aid to Capacity Evaluation. A specific capacity assessment is a semistructured evaluation of the participant's ability to understand relevant information and appreciate reasonably foreseeable consequences with regard to the specific treatment decision. Participants also received a SMMSE administered by a research nurse. Participants then had two independent expert assessments of capacity. If the two expert assessments disagreed, then an independent adjudication panel resolved the disagreement after reviewing videotapes of both expert assessments. Using the two expert assessments and the adjudication panel as the reference standard, we calculated areas under the receiver-operating characteristic curves and likelihood ratios. The areas under the receiver-operating characteristic curves were 0.90 for specific capacity assessment by treating clinician and 0.93 for SMMSE score (2p =.48). For the treating clinician's specific capacity assessment, likelihood ratios for detecting incapacity were as follows: definitely incapable, 20 (95% confidence interval [CI] 3. 6, 120); probably incapable, 6.1 (95% CI 2.6, 15); probably capable, 0.39 (95% CI 0.18, 0.81); and definitely capable, 0.05 (95% CI 0.01, 0.29). For the SMMSE, a score of 0 to 16 had a likelihood ratio of 15 (95% CI 5.3, 44), a score of 17 to 23 had a likelihood ratio of 0. 68 (95% CI 0.35, 1.2), and a score of 24 to 30 had a likelihood ratio of 0.05 (95% CI 0.01, 0.26). CONCLUSIONS: Specific capacity assessments by the treating clinician and SMMSE scores agree closely with results of expert assessments of capacity. Clinicians can use these practical, flexible, and evaluated measures as the initial step in the assessment of patient capacity to consent to treatment.

A bedside clinical prediction rule for detecting moderate or severe aortic stenosis.

OBJECTIVE: To evaluate a bedside clinical prediction rule for detecting moderate or severe aortic stenosis. DESIGN: Cross-sectional study with independent comparison to a diagnostic reference standard, doppler echocardiography. SETTING: Urban university hospital. PARTICIPANTS: Consecutive hospital inpatients (n = 124) who had been referred for echocardiography. MEASUREMENTS AND MAIN RESULTS: Participants were examined by a third-year general internal medicine resident and a staff general internist. We hypothesized in advance that absence of a murmur over the right clavicle would rule out aortic stenosis, while the presence of three or four associated findings (slow carotid artery upstroke, reduced carotid artery volume, maximal murmur intensity at the second right intercostal space, and reduced intensity of the second heart sound) would rule in aortic stenosis. Study physicians were unaware of echocardiographic findings. The outcome was echocardiographic moderate or severe aortic stenosis, defined as a valve area of 1.2 cm2 or less, or a peak instantaneous gradient of 25 mm Hg or greater. Absence of a murmur over the right clavicle ruled out aortic stenosis (likelihood ratio [LR] 0.10; 95% confidence interval [CI] 0.01, 0.44). The presence of three or four associated findings ruled in aortic stenosis (LR 40; 95% CI 6.6, 240). If a murmur was present over the right clavicle, but no more than two associated findings were present, then the examination was indeterminate (LR 1.8; 95% CI 0.93, 2.9). CONCLUSION: A clinical prediction rule, using simple bedside maneuvers, accurately ruled in and ruled out aortic stenosis.

Accuracy of clinical impressions and Mini-Mental State Exam scores for assessing capacity to consent to major medical treatment. Comparison with criterion-standard psychiatric assessments.

The authors evaluated the accuracy of clinical impressions and Mini-Mental State Exam scores for assessing patient capacity to consent to major medical treatment, relative to expert psychiatric assessment. Consecutive medical inpatients (N = 63) facing a decision about major medical treatment received a clinical impression of capacity from their treating physician and the Standardized Mini-Mental State Exam (SMMSE); 48 received independent psychiatric assessment of capacity. Analyses revealed that both clinical impressions and SMMSE scores were generally inaccurate in determining capacity, although all 23 participants with a clinical impression of "definitely capable" were found capable by the psychiatrist. Given the importance of assessing capacity to consent to major medical treatment, better approaches to the clinical assessment of capacity are required. Several strategies are discussed.

Does this patient have an abnormal systolic murmur?

Our objective was to review the available evidence of the precision and accuracy of the clinical examination for abnormal systolic murmurs. We conducted a MEDLINE search, manually reviewed all reference lists, and contacted authors of published studies. Each study was independently reviewed by 2 observers and graded for methodologic quality. We found that most studies were conducted using cardiologist examiners. In the clinical setting, the reliability of detecting systolic murmurs was fair (kappa, 0.30-0.48). The most useful findings for ruling in aortic stenosis are a slow rate of rise of the carotid pulse (positive likelihood ratio, 2.8-130), mid to late peak intensity of the murmur (positive likelihood ratio, 8.0-101), and decreased intensity of the second heart sound (positive likelihood ratio, 3.1-50). The most useful finding for ruling out aortic stenosis is the absence of murmur radiation to the right carotid artery (negative likelihood ratio, 0.05-0.10). Smaller, lower-quality studies indicate that cardiologists can accurately rule in and rule out mitral regurgitation, tricuspid regurgitation, hypertrophic cardiomyopathy, and echocardiographic mitral valve prolapse. We conclude that the clinical examination by cardiologists is accurate for detecting various causes of abnormal systolic murmurs. Studies of the clinical examination by noncardiologists are needed.

Laser scanning tomography of the optic nerve head in ocular hypertension and glaucoma.

BACKGROUND: This study evaluated the ability of laser scanning tomography to distinguish between normal and glaucomatous optic nerve heads, and between glaucomatous subjects with and without field loss. METHODS: 57 subjects were classified into three diagnostic groups: subjects with elevated intraocular pressure, normal optic nerve heads, and normal visual fields (n = 10); subjects with glaucomatous optic neuropathy and normal visual fields (n = 30); and subjects with glaucomatous optic neuropathy and repeatable visual field abnormality (n = 17). Three 10 degrees image series were acquired on each subject using the Heidelberg retina tomograph (HRT). From the 14 HRT stereometric variables, three were selected a priori for evaluation: (1) volume above reference (neuroretinal rim volume), (2) third moment in contour (cup shape), and (3) height variation contour (variation in relative nerve fibre layer height at the disc margin). Data were analysed using analysis of covariance, with age as the covariate. RESULTS: Volume above reference, third moment in contour, and mean height contour were significantly different between each of the three diagnostic groups (p < 0.001). Height variation contour showed no significant difference among the three diagnostic groups (p = 0.906). CONCLUSIONS: The HRT variables measuring rim volume, cup shape, and mean nerve fibre layer height distinguished between (1) subjects with elevated intraocular pressures and normal nerve heads, and glaucomatous optic nerve heads, and (2) glaucomatous optic nerve heads with and without repeatable visual field abnormality. This study did not directly assess the ability of the HRT to identify patients at risk of developing glaucoma. It is hypothesised that the greatest potential benefit of laser scanning tomography will be in the documentation of change within an individual over time.

National survey on the attitudes of Canadian physicians towards drug-detailing by pharmaceutical representatives.

OBJECTIVE: Our objective was to study the attitudes of Canadian physicians toward product presentations by pharmaceutical representatives (PRs), the use of inducements by the pharmaceutical industry, and methods to improve the quality of prescribing information provided to physicians. DESIGN: We used a mailed survey. PARTICIPANTS: A random sample of 550 Canadian physicians in all settings was chosen. OUTCOME MEASURES: The main outcome measure was the proportion of respondents agreeing with a series of statements. RESULTS: The response rate was 262 of 525 deliverable surveys (50 per cent). Respondents had a mean of 4.2 interactions per week with PRs. Of the 262 respondents (5.8 per cent of data were incomplete), 193 (80 per cent) believed that PRs overemphasize their products' effectiveness, 108 (45 per cent) thought PRs do not present fairly the drugs' negative aspects, and 223 (92 per cent) felt that PRs have production promotion as a goal. Most, 175 (70 per cent), believe that drug-detailing affects physicians' prescribing behavior. Most, 210 (86 per cent), considered drug samples acceptable, but fewer agreed that other inducements were acceptable. Of the respondents, 183 (74 per cent) agreed that PRs should be required to use guidelines for standardized, comprehensive drug-detailing, and 165 (65 per cent) agreed that face-to-face drug-detailing by PRs using standardized guidelines would be an effective way to receive information. CONCLUSIONS: There is dissatisfaction among Canadian physicians about the quality of information provided by the pharmaceutical industry. Standardized, comprehensive guidelines would be accepted by physicians as one improvement.

Bioethics for clinicians: 4. Voluntariness.

In the context of consent, "voluntariness" refers to a patient's right to make health care choices free of any undue influence. However, a patient's freedom to make choices can be compromised by internal factors such as pain and by external factors such as force, coercion and manipulation. In exceptional circumstances--for example, involuntary admission to hospital--patients may be denied their freedom of choice; in such circumstances the least restrictive means possible of managing the patient should always be preferred. Clinicians can minimize the impact of controlling factors on patients' decisions by promoting awareness of available choices, inviting questions and ensuring that decisions are based on an adequate, unbiased disclosure of the relevant information.