Common musculoskeletal adverse effects of oral treatment with once weekly alendronate and risedronate in patients with osteoporosis and ways for their prevention.

OBJECTIVE: To examine in a major cohort of patients whether or not musculoskeletal adverse effects (MAEs), similar to those seen in intravenous bisphosphonates (BP), might occur also in high dosage oral treatment regimens with alendronate (ALN) and risedronate (RSN). PATIENTS AND METHODS: 612 consecutive patients treated in the osteoporosis outpatient clinic at Charite, Campus Benjamin Franklin, between July 2002 and October 2003 with oral ALN or RSN (mean age 68.2+/-9.7 years; 527 females, 85 males), were examined and followed up for MAEs. RESULTS: The overall frequency of any severe MAEs in our patients was low (5.6%). All severe MAEs occurred in primarily once weekly treated patients: 27 in ALN 70 mg once weekly (27/134=20.1%) and 7 in RSN 35 mg once weekly (7/28=25.0%), with no significant difference between those groups. The most frequently reported MAE was acute arthralgia in 12.6%, followed by acute back pain in 9.1% of all primarily once weekly treated cases. None of the 302 patients initially treated with daily BP reported any MAEs when later switching to once weekly administration (218 patients to ALN 70 mg once weekly and 84 patients to RSN 35 mg once weekly). With reference to recently published data, the phenomenon is probably related to dose dependent gammadelta T cell activation by accumulation of isopentenyl pyrophosphate (IPP) due to inhibition of the mevalonate pathway by nitrogen containing bisphosphonates (nBP). CONCLUSIONS: MAEs in oral BP are, in general, less common and severe than in intravenous BP. They are observed exclusively in patients starting ALN or RSN treatment with once weekly dosage regimens. In order to avoid this phenomenon, it is suggested to start ALN or RSN treatment with the lower daily dosages of ALN 10 mg daily or RSN 5 mg daily for about two weeks before switching to the overall, more convenient, once weekly dose regimen.

Risk factors for infection in patients with traumatic lacerations.

BACKGROUND: Most of our knowledge of laceration management comes from studies in animal models or patients with closure of sterile postoperative surgical incisions. Traumatic laceration management has not been well studied. OBJECTIVE: To determine which characteristics of traumatic lacerations were associated with the development of wound infection. METHODS: A cross-sectional study of consecutive patients with traumatic lacerations repaired over a four-year period was conducted. Structured closed-question data sheets were prospectively completed at the time of laceration repair and suture removal. Infection was determined at the time of suture removal. Multivariate modeling was used to determine the adjusted odds ratio (OR) of infection. RESULTS: Five thousand five hundred twenty-one patients were enrolled; 195 patients developed an infection (3.5%). An increased likelihood of wound infection was associated with age (adjusted OR per year, 1.01; 95% CI = 1.0 to 1.02); history of diabetes mellitus (adjusted OR 6.7; 95% CI = 1.7 to 26.4); laceration width (adjusted OR 1.05 per mm; 95% CI = 1.02 to 1.08); and presence of foreign body (adjusted OR 2.6; 95% CI = 1.3 to 5.2). Laceration location on the head/neck was associated with a decreased risk of infection (adjusted OR 0.28; 95% CI = 0.18 to 0.45). CONCLUSIONS: Both patient and wound characteristics of traumatic lacerations have an influence on the likelihood of infection. This knowledge may be valuable for determining whether various methods of wound cleansing, debridement, and repair can improve the outcome of patients with traumatic lacerations.

Emergency department observation of poisoned patients: how long is necessary?

OBJECTIVE: To compare the emergency physician disposition decisions after observation periods of two, four, and six hours in a single cohort of ED patients with acute intentional ingestion to determine the accuracy of disposition decisions at two and four hours relative to the six-hour period of observation. METHODS: This was a prospective observational study at two university hospital EDs. Study participants were patients with potentially toxic oral ingestions occurring less than six hours prior to ED presentation. Patients with isolated recreational drug or ethanol use were excluded. Structured data forms were completed at presentation, and two, four, and six hours later. Data included signs and symptoms consistent with toxic ingestion, physical examination, laboratory determinations, medications ingested, treatment, and suicide risk. At two and four hours, physicians were asked to determine whether they thought the patient was safe for medical clearance. These patients continued to be observed for six hours. The main outcome was whether patients initially thought to be appropriate for early medical clearance were ultimately cleared at six hours. RESULTS: There were 260 patients enrolled: 28 were immediately admitted to the hospital and 17 were immediately discharged; 215 entered ED observation. Patients had a mean age of 24 years; 55% were female; 50% were suicidal; 17% had toxidromes. Of the 215 observed patients, 106 (49%) were deemed safe for early medical clearance at two hours. All 106 were ultimately cleared at six hours (100%, 95% CI = 97% to 100%). Of the 109 not safe for early medical clearance at two hours, 61 (56%) were deemed safe for early medical clearance at four hours; all 61 were subsequently discharged at six hours (100%; 95% CI = 95% to 100%). Overall, 167 of 215 (77%) observed overdose patients were deemed safe for early medical clearance after two or four hours of observation. All 167 were ultimately cleared at six hours (100%; 95% CI = 98.2% to 100%). CONCLUSIONS: A large subset of overdose patients who are medically cleared after six hours of observation can be identified within two to four hours of presentation. No patient who was believed to be safe for medical clearance at either two or four hours had a complication within the six-hour time period (95% CI = 0% to 1.8%). These data suggest that asymptomatic patients with selected acute intentional ingestions can be released from medical observation in less than six hours.

Cutaneous tape stripping to accelerate the anesthetic effects of EMLA cream: a randomized, controlled trial.

UNLABELLED: Most medications are not absorbed topically due to the stratum corneum barrier. While effective as a topical anesthetic, EMLA cream is absorbed slowly, delaying its effects for up to one hour, thereby limiting its usefulness. OBJECTIVE: To determine whether removal of the cornified layer of the skin by tape stripping (TS) would allow more rapid onset of anesthesia after topical application of EMLA cream prior to IV catheterization (IVC). METHODS: This was a prospective, randomized, controlled trial comparing the levels of pain of IVC 15 minutes after topical application of EMLA cream in patients who had TS vs patients who did not. The setting was a suburban university-affiliated ED. A convenience sample of 68 alert adult patients requiring IVC were enrolled. The primary outcomes measured were pain of IVC and pain of TS using a previously validated 100-mm visual analog scale as well as the IVC success rate. RESULTS: The pain of IVC was less for TS vs control patients [29.7 mm (95% CI=20.4 to 39.0 mm) vs 15.9 mm (95% CI=9.1 to 22.6 mm), p=0.017]. The mean pain of TS was 4.8+/-7.4 mm. The IVC success rate for TS vs control patients was 91% vs 74% (p=0.056). There were no adverse events after TS. CONCLUSIONS: Removal of the cornified layer of the skin resulted in a more rapid anesthetic effect of EMLA cream as evidenced by lower IVC pain scores after TS. The effectiveness of TS for enhanced absorption of other medications should be investigated.

Prospective, randomized, controlled trial of tissue adhesive (2-octylcyanoacrylate) vs standard wound closure techniques for laceration repair. Stony Brook Octylcyanoacrylate Study Group.

OBJECTIVE: To compare a new tissue adhesive, 2-octylcyanoacrylate, with standard wound closure techniques for the repair of traumatic lacerations. METHODS: A prospective, randomized, controlled clinical trial enrolled consecutive patients > 1 year of age with non-bite, non-crush-induced lacerations who presented < 6 hours after injury. Structured closed-question data sheets were completed at the time of laceration repair and suture removal. Patients were randomly assigned to treatment with either 2-octylcyanoacrylate or standard wound closure. Infection was determined at the time of suture removal. Long-term cosmetic appearance (> 3 months) was assessed by physicians using a previously validated categorical cosmetic scale and by patients using a 100-mm visual analog scale. RESULTS: There were 63 patients randomized to the octylcyanoacrylate group and 61 patients treated with standard wound closure techniques. The 2 treatment groups were similar with respect to age, gender, race, medical history, and wound characteristics. At the 5-to-10-day follow-up, only 1 wound was infected and only 2 wounds required reclosure due to dehiscence. These 3 patients received treatment with octylcyanoacrylate. At long-term follow-up, the cosmetic appearances were similar according to the patients (octylcyanoacrylate, 83.8 +/- 19.4 mm vs standard techniques, 82.5 +/- 17.6 mm; p = 0.72) and the physicians (optimal cosmetic appearance, 77% vs 80%; p = 0.67). CONCLUSIONS: Wounds treated with octylcyanoacrylate and standard wound closure techniques have similar cosmetic appearances 3 months later.

Long-term evaluation of cosmetic appearance of repaired lacerations: validation of telephone assessment. The Stony Brook Wound Registry Study Group.

OBJECTIVE: Patients with lacerations are most concerned about the ultimate cosmetic appearance of their wound. We evaluated methods to assess the long-term cosmetic appearance by telephone survey. METHODS: Patients with lacerations repaired in the ED were contacted by telephone and had direct examination a mean of 112 days after injury. At the time of telephone contact to schedule the ED follow-up visit, patients completed a structured survey instrument. Patients rated their laceration appearance from 0 to 100, and completed a 6-item categorical assessment of cosmetic appearance. During ED follow-up, patients assessed satisfaction with a 100-mm visual analog scale (VAS), a 0 to 100 numerical scale, and the same 6-item categorical scale. The criterion standard was the validated 6-item categorical scale used by physicians. A score of 6 is optimal; less than 6 is suboptimal. RESULTS: A total of 103 patients participated (mean age 17 years; 55% male subjects). Wounds were mostly located on the head (72%) and upper extremity (24%). Mean wound length was 1.9 cm. On all numerical scales (numerical assessment by telephone, assessment in the ED by VAS, and by 0 to 100 scale in the ED) the patients considered the wound better when the physicians considered the cosmetic appearance to be optimal (87 mm versus 71 mm; 90 mm versus 73 mm; 90 mm versus 73 mm, respectively; P < .01 for all comparisons). The relationship between the 0 to 100 numerical rating scale used in the ED and that used during the telephone survey revealed a strong relationship. The scales had a mean difference of 2.1 mm (95% confidence interval -26 to 30 mm). However, patient categorical scale assessment from the phone interview was not concordant with physician assessment in the ED (kappa = .12). CONCLUSION: The long-term cosmetic appearance of lacerations repaired in the ED can be assessed by asking patients to grade their lacerations from 0 to 100 over the telephone. By contrast, categorical assessment over the telephone is not concordant with physician assessment in the ED. This information may allow easier assessment of injuries and their long-term consequences.

Assessment of cocaine use in patients with chest pain syndromes.

BACKGROUND: Patients with myocardial ischemia may have different dispositions and/or pharmacologic interventions based on whether they have recently used cocaine. OBJECTIVE: To determine the prevalence of assessment of cocaine use in patients with acute chest pain syndromes. METHODS: In phase 1 of the study, we reviewed the medical records of all patients with chest pain who presented to the emergency department during February 1996 to assess historical documentation of the presence or absence of cocaine use. In phase 2, we evaluated whether cocaine questions were asked but not documented. After hospital admission, patients were interviewed to see if they were asked about cocaine use. In phase 3, we evaluated possible recall bias by using standardized questioning in the emergency department and used subsequent interviews to assess recall. Assessment of other cardiac risk factors served as the comparison group. RESULTS: In phase 1, 129 charts were reviewed, 13% of which revealed myocardial infarction. The presence or absence of cocaine use (13%) was less frequently documented than the presence or absence of hypercholesterolemia (58%), hypertension (82%), smoking (90%), diabetes (73%), or family history (77%) (chi 2, P < .05 for all comparisons). In phase 2, 27 (31%) of the 86 patients who were interviewed recalled cocaine questioning. There was chart documentation of the cocaine questioning in only 44% of the 27 cases. In phase 3, while in the emergency department, 20 patients were asked about cocaine use: 19 (95%) recalled being asked about cocaine use when interviewed the next day. CONCLUSIONS: Patients with chest pain often are not asked about recent cocaine use. When they are asked, their answers are poorly documented. These findings cannot be explained by poor recall. In cases of chest pain, efforts to improve questioning of patients about cocaine use are needed, since recent cocaine use may change treatment, disposition, and need for counseling.

Effect of duration from symptom onset on the negative predictive value of a normal ECG for exclusion of acute myocardial infarction.

STUDY OBJECTIVE: We hypothesized that the negative predictive value of the ECG would improve with time and assessed the effect of time elapsed from symptom onset to ED presentation on the negative predictive value, sensitivity, specificity, and positive predictive value of the initial ECG in patients presenting with symptoms suggestive of acute myocardial infarction (AMI). METHODS: We conducted a cross-sectional study in a university teaching hospital. Our structured data instrument, completed at the time of presentation included demographics, time of onset of symptoms, history, laboratory, and ECG findings. AMI was diagnosed with the use of international diagnostic criteria. Patients were stratified according to duration of time from symptom onset at 3-hour intervals. RESULTS: We enrolled 526 patients in the study group. The mean age was 59 years; 40% were female. The mean time elapsed from symptom onset to presentation was 185 minutes. A diagnosis of AMI was made in 104 patients (20%). The negative predictive values of a normal ECG for exclusion of AMI, stratified by duration of time from symptom onset, were: 0 to 3 hours, 93.2% (95% confidence interval [CI], 87.4% to 96.1%); 3 to 6 hours, 93.0% (95% CI, 83.0% to 98.1%); 6 to 9 hours, 92.6% (95% CI, 75.8% to 99.1%); and 9 to 12 hours, 94.1% (95% CI, 71.3% to 99.9%) (P = 1.0). The sensitivity, specificity, and positive predictive value of the ECG were similar in all groups. CONCLUSION: The negative predictive value of a normal ECG for exclusion of AMI does not improve as the duration of time from symptom onset to presentation increases. Normal ECG findings cannot be used to rule out an AMI, even those obtained up to 12 hours after symptom onset.

Are monitored telemetry beds necessary for patients with nontraumatic chest pain and normal or nonspecific electrocardiograms?

We evaluated the frequency of cardiovascular complications in chest pain patients with normal or non-specific electrocardiograms admitted to noncardiac care unit monitored beds and found that none of 261 patients had life-threatening dysrrhythmias requiring treatment.

Academic associate program: integrating clinical emergency medicine research with undergraduate education.

An educational program that teaches undergraduate students about clinical research related to emergency medicine is described. The students work as research assistants within the ED, thus providing a departmental framework for the enrollment of patients in clinical studies. Volunteers interested in the program undergo a physical examination, vaccination history, and standard serologic testing, and sit through a formal blood and body fluid exposure course offered by the university prior to their clinical research participation. A didactic curriculum on clinical research concepts and course examinations is provided. Over the 4 years since the department established its departmental research goals and this educational program, the departmental publication rate has increased from 2 to 20 manuscripts. While there was only 1 faculty member with a research publication in 1992, there were 9 faculty with manuscripts accepted for publication in the first 6 months of 1996. Similarly, more nurses and ancillary staff have become involved in prospective clinical research. Much of this success is attributed to the novel use of resources through the academic associate program.

Comparison of patient satisfaction and practitioner satisfaction with wound appearance after traumatic wound repair.

INTRODUCTION: Existing cosmetic scales for wounds are based only on practitioners' evaluations. They have not been validated using the patient's assessment. OBJECTIVE: To validate a previously developed wound cosmesis scale by determining the relationship between patient and practitioner assessments of cosmetic outcome following traumatic wound repair. METHODS: A convenience sample of patients with lacerations repaired in an ED were evaluated at the time of suture removal. Practitioners assigned 0 or 1 point each for the presence or absence of a step-off of borders; contour irregularities; margin separation; edge inversion; excessive distortion; and overall appearance. A total cosmetic score was calculated by adding the categories above. As previously defined, a score of 6 was considered optimal; < 6 was considered "suboptimal." Patients, blinded to the physician score, assessed their degrees of satisfaction with the cosmetic outcome of the wounds using a 100-mm visual analog scale (VAS). Because VAS scores were not normally distributed, practitioner scores were compared with patient satisfaction scores using a Mann-Whitney U test. RESULTS: 125 patients were enrolled, of whom 64% were male; the median age was 19.5 years (interquartile range = 8-33 years). Wounds were located predominantly on the face, scalp, or neck (47%) and upper extremity (35%), and had a median length of 2 cm. The 86 lacerations given optimal practitioner scores had a median patient satisfaction score of 97 mm; the 39 "suboptimal" lacerations had a median patient satisfaction score of 87 mm (p = 0.0006). CONCLUSION: Lacerations that practitioners considered to have optimal cosmetic appearances at the time of suture removal received higher patient satisfaction scores than did lacerations considered to be suboptimal. This provides a measure of validity to this 6-item categorical cosmetic scale.

Comparison of wound infection rates using plain versus buffered lidocaine for anesthesia of traumatic wounds.

Buffered lidocaine has been shown to be less painful than plain lidocaine for anesthetizing wounds. However, the effect of a buffering agent on the local host defenses has not been evaluated. The infection rates of wounds anesthetized with plain lidocaine versus buffered lidocaine were compared in an observational cohort study. Consecutive emergency department patients with traumatic wounds that required sutures had a closed-question wound registry sheet prospectively completed. Follow-up data were obtained at the time of the return visit. Patients failing to return were contacted by telephone. Data were analyzed for wound infection rates comparing plain lidocaine with buffered lidocaine. Chi-squared or Fisher exact tests were used for statistical analysis. Of 2,711 patients analyzed, 2,279 had received plain and 432 had received buffered lidocaine. The infection rate for patients treated with plain lidocaine was 3.5%, versus that for patients treated with buffered lidocaine, 3.9% (P = .63). After adjustment for confounding variables, the infection rate did not differ between plain and buffered lidocaine. The infection rates of wounds repaired after anesthesia with either plain or buffered lidocaine are similar.

Association of training level and short-term cosmetic appearance of repaired lacerations.

OBJECTIVE: To determine the association between emergency practitioner level of training and cosmetic appearance of primarily closed wounds as evaluated at the time of suture removal. METHODS: A retrospective analysis of wound registry data was performed. At the time of wound closure, standard data were collected including details of patient demographics, wound characteristics, preparation, closure, and postoperative care, for consecutive patients sutured in the ED. Follow-up data were obtained at the time of the return visit using a previously described cosmetic scale. With the scale, all lacerations were assigned 0 or 1 point each for the presence or absence of six items: a step-off of borders; contour irregularities; margin separation; edge inversion; excessive distortion; and overall appearance. For analysis, the proportion of wounds with a score of 6 (optimal cosmetic appearance in all categories) was associated with practitioner level of training. RESULTS: Five hundred fifty-two patients' wounds were evaluated. The percentages of various practitioners' achieving an optimal cosmetic score were: medical students (MSs), 50%; first-year residents (EM1s), 54%; second-year residents (EM2s), 66%; third-year residents (EM3s), 68%; physician assistants (PAs), 70%; and attending physicians (APs), 66%. The senior practitioners (EM2s, EM3s, PAs, APs) were significantly more likely to obtain a maximal cosmetic score than were the junior practitioners (MSs, EM1s) (68% vs 52%, p = 0.016). CONCLUSION: Significant improvement in short-term cosmetic results following wound repair is associated with a training level beyond PGY1. These data reinforce the need for careful patient selection and close supervision of wound repair by trainees, especially of wound repair by medical students and interns.

Level of training, wound care practices, and infection rates.

This prospective, nonrandomized descriptive study compares the traumatic wound infection rates in patients based on level of training of emergency department (ED) practitioners. Wounds were evaluated in 1,163 patients. A wound registry data sheet was prospectively completed on all patients sutured in the ED. All practitioners were assigned a unique identification number. Follow-up data was obtained at the time of the return visit. Patients failing to return were contacted by telephone. Data were analyzed for patient wound infection rates by practitioner level of training. Patient wound infection rates by practitioner level of training were: medical students, 0/60 (0%); all resident physicians, 17/547 (3.1%); physician assistants, 11/305 (3.6%); and attending physicians 14/251 (5.6%), P was not significant. Comparison of junior (medical students and interns) to senior practitioners (all other practitioners) found no difference in infection rates (8/262 [3.1%] v 34/901 [3.8%], P = .58). In conclusion, carefully selected patients sutured by closely supervised medical students and junior residents have infection rates as low as those sutured by more experienced practitioners.