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PubMed1975

Evaluation of patient-care protocol use by various providers.

A symptom-oriented protocol for acute pharyngitis was evaluated in a busy general medical clinic staffed by physicians and graduate and student physician's assistants. We observed significantly improved performance by all providers in collection of medical data, utilization of laboratory tests,and appropriate use of antibiotics after introduction of the protocol. Patient charges were less when the protocol was used, but these savings were offset partially by the cost of audit. Compliance with and acceptance of the protocol differed among the various health providers, with physicians demonstrating significantly lower levels than nonphysicians. Patient-care protocols provide an effective means of monitoring the process of medical care, detecting weakness in supportive clinic services, and affording educational feedback for all health providers.

Clinical Laboratory Techniques↗

PubMed1982

A protocol for selecting patients with injured extremities who need x-rays.

To help curb excessive radiography, we developed a protocol for selecting patients with injured extremities who need x-ray examination, and we tested the protocol prospectively in 848 patients to determine its safety and effectiveness. Strict adherence to the protocol would have reduced x-ray usage by 12 per cent for upper extremities and 19 per cent for lower extremities. The actual reductions were 5 per cent and 16 per cent, respectively, since further reductions were limited by patient's demands for x-ray examinations. One fracture in 287 were missed, but the treatment was appropriate and the outcome satisfactory. By eliminating superfluous x-ray procedures, the protocol could reduce charges by $79 million to $139 million nationwide, without compromising quality of care or increasing malpractice liability. Nevertheless, even the best protocol cannot eliminate all negative x-ray studies. These results should serve as a stimulus for judicious use of radiography, but also as a warning to avoid overzealous cost-containment strategies that would reduce x-ray usage to below a safe threshold.

Connecticut↗

PubMed1982

A computer-derived protocol to aid in the diagnosis of emergency room patients with acute chest pain.

To determine whether data available to physicians in the emergency room can accurately identify which patients with acute chest pain are having myocardial infarctions, we analyzed 482 patients at one hospital. Using recursive partitioning analysis, we constructed a decision protocol in the format of a simple flow chart to identify infarction on the basis of nine clinical factors. In prospective testing on 468 other patients at a second hospital, the protocol performed as well as the physicians. Moreover, an integration of the protocol with the physicians' judgments resulted in a classification system that preserved sensitivity for detecting infarctions, significantly improved the specificity (from 67 per cent to 77 per cent, P less than 0.01) and positive predictive value (from 34 per cent to 42 per cent, P = 0.016) of admission to an intensive-care area. The protocol identified a subgroup of 107 patients among whom only 5 per cent had infarctions and for whom admission to non-intensive-care areas might be appropriate. This decision protocol warrants further wide-scale prospective testing but is not ready for routine clinical use.

Adult↗

PubMed2002

Predictors of protocol adherence in a pediatric asthma clinical trial.

BACKGROUND: Declining protocol adherence can threaten the validity of a clinical trial. OBJECTIVE: We sought to explore patient and family factors important for protocol adherence in the 133 patients followed at one of the 8 Childhood Asthma Management Program (CAMP) clinical centers. Difficulties with timely return of diary cards (diary card problem), with keeping or frequently rescheduling appointments (appointment problem), and with commitment to all aspects of the trial (commitment problem) were tracked prospectively during the treatment phase of CAMP, which ranged from 20 to 40 months at the time of the analysis. METHODS: We performed a cross-sectional analysis. RESULTS: During the course of this investigation, no St Louis CAMP patients dropped out of the study, although signs of eroding participation were observed in 44% of patients. For this cross-sectional analysis, the percentage of patients exhibiting protocol-adherence problems was greater the longer patients had been in the trial: 33.3% at 20 to 25 months, 39.5% at 26 to 30 months, 51.4% at 31 to 35 months, and 69.2% at 36 to 40 months (P <.01). The diary card problem was present in 22.2% of the patients enrolled in the trial for 20 to 25 months compared with 66.7% for patients enrolled for 36 to 40 months (P <.005). Appointment and commitment problems were present in smaller percentages of patients and did not change by time in the trial (P =.41 and.22, respectively). A logistic regression analysis of demographic characteristics indicated that age at randomization and time in the trial were significant factors: for every 2-year increase in age, a child was twice as likely to have a commitment problem (odds ratio [OR], 1.96; 95% CI, 1.50-2.57), and for each additional 5 months of participation in the study, a child was twice as likely to have a diary card problem (OR, 1.91; 95% CI, 1.76-2.07). There was no influence of family income, patient race, or patient sex on the occurrence of any of the 3 protocol-adherence problems. A similar analysis of psychologic characteristics of the child and family indicated (1) a 2-fold increase in the risk of a diary card problem with a 10% increase in the percentage of total commissions on the attention scale of the Gordon Diagnostic Study (OR, 2.18; 95% CI, 2.02-2.35), (2) a 2-fold decrease in the risk of an appointment problem with a 10-unit increase in the Child Manifest Anxiety Scale (OR, 0.46; 95% CI, 0.44-0.49), (3) a 2-fold decrease in risk of an appointment problem with a 10-unit increase in the cohesion subscale of the Family Environment Scale (OR, 0.58; 95% CI, 0.55-0.60), and (4) a 5-fold decrease in the risk of a commitment problem with a 10-unit increase in the Child Depression Index score (OR, 0.21; 95% CI, 0.18-0.24). CONCLUSIONS: Adherence and retention problems commonly occur in longer clinical trials. CAMP patients and families were selected in part on the basis of likelihood of being able to participate in the trial to enhance the conclusions of the trial. Despite this selection process, adherence problems were noted. Problems increased with duration of participation, increasing child age, and the presence of less family cohesion or attention problems in the child. In contrast, the presence of mild emotional distress (anxiety and depression) in the child was associated with fewer protocol-adherence problems. Incorporating procedures that help anticipate and identify adherence problems early might improve continued participation in all aspects of a trial and even retention in long-term clinical trials.

Adolescent↗

PubMed2002

The Erlanger chest pain evaluation protocol: a one-year experience with serial 12-lead ECG monitoring, two-hour delta serum marker measurements, and selective nuclear stress testing to identify and exclude acute coronary syndromes.

STUDY OBJECTIVE: We determine the overall use of a 6-step accelerated chest pain protocol to identify and exclude acute coronary syndrome (ACS) and to confirm previous findings of the use of serial 12-lead ECG monitoring (SECG) in conjunction with 2-hour delta serum marker measurements to identify and exclude acute myocardial infarction (AMI). METHODS: A prospective observational study was conducted over a 1-year period from January 1, 1999, through December 31, 1999, in 2,074 consecutive patients with chest pain who underwent our accelerated evaluation protocol, which includes 2-hour delta serum marker determinations in conjunction with automated SECG for the early identification and exclusion of AMI and selective nuclear stress testing for identification and exclusion of ACS. In patients not undergoing emergency reperfusion therapy, physician judgment was used to determine patient disposition at the completion of the 2-hour evaluation period: admit for ACS, discharge or admit for non-ACS condition, or immediate emergency department nuclear stress scan for possible ACS. A positive protocol was defined as a positive result in 1 or more of the 6 incremental steps in our chest pain evaluation protocol: (1) initial ECG diagnostic of acute injury or reciprocal injury; (2) baseline creatine kinase (CK)-MB level of 10 ng/mL or greater and index of 5% or greater or cardiac troponin I level of 2 ng/mL or greater; (3) new/evolving injury or new/evolving ischemia on SECG; (4) increase in CK-MB level of +1.5 ng/mL or greater or cardiac troponin I level of +0.2 ng/mL or greater in 2 hours; (5) clinical diagnosis of ACS despite a negative 2-hour evaluation; and (6) reversible perfusion defect on stress scan compared with on resting scan. All patients were followed up for 30-day ACS, which was defined as myocardial infarction (MI), percutaneous coronary intervention/coronary artery bypass grafting, coronary arteriography revealing stenosis of major coronary artery of 70% or greater not amenable to percutaneous coronary intervention/coronary artery bypass grafting, life-threatening complication, or cardiac death within 30 days of ED presentation. RESULTS: Discharge diagnosis in the 2,074 study patients consisted of 179 (8.6%) patients with AMI, 26 (1.3%) patients with recent AMI (decreasing curve of CK-MB), and 327 (15.8%) patients with 30-day ACS. At 2 hours, sensitivity and specificity for MI (AMI or recent AMI) of SECG plus delta serum marker measurements was 93.2% and 93.9%, respectively (positive likelihood ratio 15.3; negative likelihood ratio 0.07). At the completion of the full ED evaluation protocol (positive result in >or=1 of the 6 incremental steps), sensitivity and specificity for 30-day ACS was 99.1% and 87.4%, respectively (positive likelihood ratio 7.9; negative likelihood ratio 0.01). CONCLUSION: An accelerated chest pain evaluation strategy consisting of SECG, 2-hour delta serum marker measurements, and selective nuclear stress testing in conjunction with physician judgment identifies and excludes MI and 30-day ACS during the initial evaluation of patients with chest pain.

Chest Pain↗

PubMed2000

Performance of a group B streptococcal prophylaxis protocol combining high-risk treatment and low-risk screening.

OBJECTIVE: This study was undertaken to evaluate a group B streptococcal protocol in a large community hospital that combined treatment of high-risk patients with rapid screening of low-risk patients. STUDY DESIGN: In a prospective cohort study from 1994 through 1996 laboring patients in a level III community hospital were considered to be at high risk for neonatal group B streptococcal transmission if they were at <37 weeks' gestation, if they had rupture of membranes >12 hours, if they were known carriers of group B streptococci, if they had a temperature > or =100 degrees F, if the gestation was complicated by fetal growth restriction or was a multiple gestation, or if they had a previous neonate infected with group B streptococci. High-risk patients were treated intravenously with antibiotics during labor. Low-risk patients were screened for group B streptococcal antigen by means of a rapid optical immunoassay. Patients with positive screening results were treated. Neonatal morbidity and mortality were evaluated. RESULTS: Two of 9932 infants delivered had group B streptococcal sepsis diagnosed. In the 2 previous years without a protocol 9 cases of neonatal group B streptococcal sepsis had been diagnosed in 8188 deliveries (P =.0287 by Fisher exact test). The 2 cases of group B streptococcal sepsis during the protocol were as follows: 1 infant born to a high-risk mother with delay in treatment and 1 infant born to a low-risk mother with negative results of both culture and rapid screen during labor. During the previous period 7 infected infants had been born to high-risk mothers and 2 had been born to low-risk mothers. The maternal group B streptococcal carriage rate during the study was 18%. Group B streptococcal rapid optical immunoassay sensitivity was 81%. Elapsed time from screening to treatment was < or =2(1/2) hours for 93% of patients. No maternal anaphylaxis, no increase in bacterial neonatal sepsis caused by organisms other than group B streptococci, and no protocol-related group B streptococcal antibiotic resistance were noted. CONCLUSION: Successful implementation and maintenance of a protocol combining treatment of high-risk patients with rapid screening of low-risk patients during labor reduced neonatal group B streptococcal sepsis.

Adult↗

PubMed2001

Maternal serum screening for fetal trisomy 18: benefits of patient-specific risk protocol.

OBJECTIVE: Our goal was to evaluate the effectiveness of two approaches to screen pregnancies for trisomy 18. STUDY DESIGN: We analyzed the outcome of all pregnancies that were screen positive for trisomy 18 by multiple marker screening (alpha-fetoprotein, unconjugated estriol, and human chorionic gonadotropin) from May 1993 to June 1998. We compared the results of a fixed cutoff protocol to a protocol that incorporates maternal age to generate a patient-specific risk figure. RESULTS: A total of 45,145 patients were screened. By using the fixed cutoff protocol, 113 patients (0.25%) were screen positive. The risk-based approach was associated with a 0.55% screen-positive rate (250 patients). Eight of 12 cases (67% detection rate) of trisomy 18 were identified by using the risk method, and only 5 cases (42% detection rate) were detected by using the fixed cutoff method. By using the risk-based protocol, 21 pregnancies with chromosomal abnormalities (8, trisomy 18; 7, triploidy; 5, trisomy 21; and 1, mosaic 45X/46XX) were detected. Subsequent fetal death occurred for 42 patients whose fetuses were chromosomally normal and without structural malformations. CONCLUSION: The patient-specific risk protocol to screen for trisomy 18 is a beneficial adjunct to screening programs already in place for Down syndrome and neural tube defects. Patients found to be screen positive for trisomy 18 are at significant risk for adverse pregnancy outcome.

Adult↗

PubMed2002

A retrospective comparison of outcome of root canal treatment using two different protocols.

OBJECTIVES: This retrospective study (1) compared the outcome of root canal treatment performed by an endodontist using 1 of 2 different protocols and (2) evaluated the influence of factors affecting outcome. STUDY DESIGN: A total of 200 teeth and 489 roots (Protocol A, 83 teeth/200 roots; Protocol B, 117 teeth/289 roots) treated nonsurgically with root canal 4 to 5 years previously were examined clinically and radiographically according to strict criteria. Generalized estimating equations were used to perform logistic regression to analyze data. RESULTS: The rate of complete healing for Protocol A (78%) was similar to that of Protocol B (76%). The pulpal status (odds ratio = 2.399, P =.040) and presence (odds ratio = 1.696, P = 0.015) and size (odds ratio = 0.823, P <.001) of periapical lesion were the only factors significantly affecting treatment outcome. CONCLUSION: The preoperative status of the pulp and the presence and extent of periapical periodontitis were important prognostic determinants of treatment outcome in this study.

Adult↗

PubMed2002

Development of a porcine follicle-stimulating hormone and porcine luteinizing hormone induced ovulation protocol in the seasonally anoestrus brushtail possum (Trichosurus vulpecula).

Monovulatory brushtail possums (Trichosurus vulpecula) were stimulated with exogenous hormones during seasonal anoestrus to overcome ovarian insensitivity and induce ovulation. Seasonal ovarian insensitivity to pregnant mare serum gonadotrophin (PMSG) was overcome by a new porcine follicle-stimulating hormone/porcine luteinizing hormone (pFSH/pLH) protocol. This protocol was refined because the original treatment produced oocytes with abnormal morphology. Possums (n = 12 per group) received eight injections of pFSH of 1.5, 3.0 or 6.0 mg per injection (at 12-h intervals for 4 consecutive days). Ovulation was induced 12 h after the final pFSH injection with a 4-mg injection of pLH. Control animals were treated with the established protocol of a single injection of 15 IU of PMSG, followed 48 h later with an injection of 4 mg of pLH. All females responded to pFSH/pLH treatment, although optimal stimulation occurred in those receiving 8 x 3 mg pFSH, with 13-14 ovulations and recovery of 11-12 oocytes per female (8 x 1.5 mg pFSH: 13 ovulations, 8-9 oocytes; 8 x 6 mg pFSH: 7-8 ovulations, 4-5 oocytes). In contrast, only seven of 12 females responded to PMSG/pLH and, of those responding, only 2-3 ovulations occurred and only 1-2 oocytes per female were recovered. However, around 80% of oocytes recovered after PMSG/pLH treatment had undergone nuclear maturation (metaphase II/1st polar body) compared with around 60% of oocytes from pFSH/pLH-treated animals. In possums killed from 27 to 39 h after pLH treatment, ovulation onset was first observed from 30 h and by 31.5 h, all animals had completed ovulation. Laparoscopic artificial insemination (LAI) was performed on pFSH/pLH-treated animals to determine whether the oocytes produced were capable of fertilization. Uterine LAI performed 27.5-28.5 h after pLH treatment yielded 11/26 fertilized oocytes (up to 4-cell stage), whereas vaginal LAI performed 13-14 h after pLH treatment yielded 21/53 fertilized oocytes. A proportion of oocytes generated from the refined pFSH/pLH protocol are thus properly mature and capable of fertilization. Further refinement of the protocol is now needed to improve the yield of fully matured oocytes.

Anestrus↗

PubMed2004

Establishing normal hearing with the dichotic multiple-frequency auditory steady-state response compared to an auditory brainstem response protocol.

OBJECTIVE: To determine the clinical usefulness of the dichotic multiple-frequency (MF) auditory steady-state response (ASSR) technique for estimating normal hearing compared to a 0.5-kHz tone burst and broadband click auditory brainstem response (ABR) protocol in a sample of adults. MATERIAL AND METHODS: A comparative experimental research design was selected in order to compare estimations of normal hearing obtained with the dichotic ASSR technique at 0.5, 1, 2 and 4 kHz with a 0.5-kHz tone burst and broadband click ABR protocol. The recording times required for each procedure were also compared. Normal-hearing subjects (n = 28) were selected according to immittance values within normal limits and pure-tone behavioural thresholds of < 25 dB HL across frequencies. RESULTS: The dichotic MF ASSR estimated normal hearing to be, on average, 30-34 dB HL across the range 0.5-4 kHz. The mean estimate of normal hearing for 0.5 kHz using tone burst ABRs was 30 dB nHL and the mean click ABR threshold was 16 dB nHL, i.e. 14-18 dB better than the ASSR thresholds. The dichotic MFASSR technique recorded 8 thresholds (4 in each ear) in a mean time of 23 min. The ABR protocol recorded 4 thresholds (2 in each ear) in a mean time of 25 min. CONCLUSION: Both the dichotic MF ASSR and ABR protocols provided a time-efficient estimation of normal hearing. There was no significant difference between the tone burst ABR and MF ASSR techniques in terms of estimation of normal hearing at 0.5 kHz. The dichotic MF ASSR technique proved more time-efficient by determining more thresholds in a shorter time compared to the ABR protocol.

Adolescent↗

PubMed1991

Respiratory gas exchange during treadmill exercise testing: reproducibility and comparison of different exercise protocols.

Ten subjects performed 4 maximal exercise tests to evaluate reproducibility and effects of treadmill inclination on submaximal and maximal oxygen consumption. They performed a standard Bruce protocol twice, and 1 protocol with progressive speed increase with constant, or without, inclination. At maximal exercise there was no significant difference between the protocols in oxygen consumption, respiratory gas exchange ratio, minute ventilation, plasma lactate, serum potassium or heart rate. Exercise time and treadmill distance were shorter than Bruce protocol with inclination, and considerably prolonged without. Reproducibility for Bruce protocol was good for group comparison of oxygen consumption throughout exercise. The individual variations for oxygen consumption were small at maximal exercise, but were considerable at rest and at the lowest exercise steps, this was slightly improved by analysing longer sampling time. Thus, measurement of oxygen consumption is reliable for group analysis, but interpretation must be careful in individuals unless maximal exercise is obtained. Treadmill inclination may be adjusted according to individual preferences.

Adolescent↗

PubMed2006

An exercise protocol that simulates the activity patterns of elite junior squash.

Squash is a popular racket sport that requires intermittent activity with frequent bursts of near maximal-intensity exercise. Consequently, effective physiological and thermoregulatory responses are important contributors to performance during squash match-play. Controlled field-based simulation protocols have been introduced in a growing number of sports, which allow sports scientists to investigate changes in physiology and the efficacy of various interventions in sport-specific contexts. This study aimed to develop an exercise protocol that simulates the physiological requirements of elite squash match-play. Eight elite junior squash players (age 16.2+/-0.8 years, height 1.76+/-0.06 m, body mass 61.3+/-5.9 kg; mean+/-s) completed the following in a randomized order: (1) a squash match against a player of similar standard and (2) a squash-specific incremental exercise protocol (multistage squash test [MST]) followed by the squash simulation protocol (SSP). The multistage squash test was continued for 18.0+/-1.0 min and elicited near maximal post-MST heart rates, blood lactate concentrations and ratings of perceived exertion (198+/-9 beats.min-1, 5.7+/-1.7 mmol.l-1 and 18+/-1, respectively). The SSP was 12.2 min in length compared with mean game length during competitive matches of 10.0+/-1.6 min (P=0.27). Peak heart rates were similar during the SSP and match-play (192+/-11 and 189+/-6 beats.min-1, respectively; P=0.44). Mean exercising heart rates were similar during the SSP (180+/-8 beats.min-1) and match-play (179+/-13 beats.min-1; P=0.73). Peak blood lactate concentrations during the SSP and match-play were 3.5+/-1.5 and 2.4+/-1.2 mmol.l-1 (P=0.07), respectively. Peak ratings of perceived exertion during the SSP and match-play were similar (17+/-2 and 17+/-2, respectively; P=0.64). It was concluded that the SSP closely replicated the demands of squash match-play in elite junior squash players. Furthermore, the SSP provides coaches and scientific support staff with a controlled squash-specific exercise protocol that has potential application in the objective investigation of a range of interventions such as training programmes, nutritional supplements and strategies to maintain core body temperature.

Adolescent↗

PubMed2005

Development and implementation of a pharmacist-managed inpatient warfarin protocol.

Because of the complexities of warfarin administration and its bleeding complications, a pharmacist-managed protocol for warfarin administration was developed at Baylor University Medical Center. The protocol incorporated current clinical guidelines and evidence-based medicine. Clinical outcomes under the protocol were compared with those of usual care, physician management, in a pilot study. Twenty-nine patients were enrolled in the protocol group and 22 in the control group between August 2004 and November 2004. Results showed that patients in both groups achieved therapeutic ranges of warfarin within 6 days. However, the pharmacist-managed patients exhibited a trend toward fewer adverse drug reactions (7% vs 14%) and fewer supratherapeutic international normalized ratios (17% vs 27%) than the control group, although the difference was not statistically significant. Based on these results and the results of similar larger studies showing the effectiveness of pharmacist-managed warfarin administration, Baylor University Medical Center made the protocol available for use in the hospital in May 2005.

Journal Article↗

PubMed2001

Protocol for X-ray dosimetry in radiobiology.

PURPOSE: To harmonize X-ray dosimetry in radiobiology to allow a direct comparison of radiobiological studies performed at institutes cooperating within the framework of the European Late Effects Project Group (EULEP). MATERIALS AND METHODS: The 1985 EULEP protocol for X-ray dosimetry and exposure arrangements employed for studies of late somatic effects in mammals required serious revision, e.g. due to the replacement of calibration of dosemeters in terms of exposure by calibration in terms of air kerma free-in-air. An action group established by EULEP and the European Radiation Dosimetry Group (EURADOS) updated the 1985 protocol. RESULTS: The new EULEP-EURADOS protocol for X-ray dosimetry in radiobiology including the code of practice for irradiation of small animals and related dosimetry. The present protocol includes the changes in calibration procedures and dosimetric concepts for irradiation with medium energy X-rays since 1985. Accuracy and precision are replaced by the concept of combined (standard) uncertainty. The revised supplements provide more detailed background information. New appendices contain definitions of general terms used for measurements and mathematical expressions of the relative variances. CONCLUSION: Adherence to the present protocol will result in improved dosimetry and facilitates the comparison of results of radiobiological experiments obtained at different institutes.

Animals↗

PubMed2005

Enhanced yield and homogeneity of buffalo growth hormone by an improved chromatographic protocol.

Loss of buffalo Growth Hormone (buGH) in the various side fractions of standard buGH purification protocol has been determined quantitatively by direct binding ELISA and qualitatively by SDS-PAGE and Western blot analysis. Accounting result indicated that there was a considerable loss of buGH in the side fractions. An alternative protocol to prevent loss and to obtain a high yield of buGH has been developed by introducing anion exchange chromatography, QAE-Sephadex. This has resulted in a simple, reproducible three-step protocol. In this protocol, an extract obtained at 250 mM (NH4)2 SO4, pH 5.5, was loaded onto the QAE-Sephadex column in 0.1 M NH4 HCO3. At this salt concentration, the bulk of the buGH came as QAE unbound fraction. Some amount of buGH, together with contaminating proteins, was bound to QAE-Sephadex and these could be eluted with 1 M KCl. The immunopotency of the enriched buGH preparation "QUB" (QAE unbound fraction) in a direct binding ELISA was similar to that of the semi-pure buGH (ECS/APECS) preparation obtained using the standard protocol, but the yield was 4 times higher. The SDS-PAGE data showed that the banding pattern of standard semi-pure buGH and QUB were quite similar and QUB can be loaded onto the Sephacryl S-200 gel filtration chromatography to yield a highly purified buGH. SDS-PAGE and Western blot analyses showed the major band of buGH in QUB at the same position as in the case of standard buGH. It has also been demonstrated here that it is possible to separate buffalo prolactin (buPRL) and buGH on QAE-Sephadex.

Animals↗

PubMedDate not supplied

Effectiveness of a medical priority dispatch protocol for abdominal pain.

OBJECTIVE: Medical Priority Dispatch System (MPDS) protocols are used to determine the appropriate level of emergency medical services (EMS) response that is sent to care for patients in the prehospital setting. The objective of this study was to determine the proportion of patients with abdominal pain who would benefit from advanced life support (ALS) when called for by these protocols. METHODS: All 9-1-1 calls were processed using MPDS protocols to determine whether the patient required ALS or basic life support (BLS) services. Consecutive patients having an ALS response for a chief complaint of abdominal pain were included. Dispatch decisions that did not follow the MPDS protocols, and cases taken to facilities other than the primary study hospitals, were excluded. EMS run sheets and hospital records were reviewed to determine: 1) whether prehospital ALS interventions were required, 2) emergency department (ED) disposition, 3) hospital course, and 4) final diagnosis. Calls were classified according to the need for ALS and the seriousness of the subsequent diagnosis. Data analysis was performed by determining 95%, confidence intervals (CIs). RESULTS: Of the 343 patients classified as 1C1 or 1C2 who were transported by ALS during the time period, 227 (67%) were transported to the study hospitals. Nine (4%) were excluded because of inappropriate dispatch, leaving 218 for analysis. Hospital records were available for 186 (86%) cases, of which 12 (6%; CI 3%, 9%) were potentially life-threatening, requiring ALS intervention. Seventeen (9%; CI 5%, 1%) were non-life-threatening, but potentially benefited from ALS intervention. The remaining 157 (84%; CI 79%, 89%) were classified as not requiring ALS. CONCLUSIONS: Use of age- and gender-specific MPDS protocols for patients with a chief complaint of abdominal pain results in significant overtriage and overuse of ALS. Steps should be taken to develop key questions that provide more accurate classification of these patients that goes beyond age and gender classification alone.

Abdominal Pain↗

PubMed2005

Inference for clinical trials with some protocol amendments.

The use of adaptive methods in clinical development has become very popular in recent years due to its flexibility in modifying trial procedures and/or statistical procedures of on-going clinical trials. Modifications to trial procedures are usually documented by protocol amendments. However, the actual patient population after protocol amendments could deviate from the originally targeted patient population. In addition, protocol amendments made based on accrued data of the on-going trial may distort the sampling distribution of the statistic designed for the case of no protocol change. In this article, we model the population deviations due to protocol amendments using some covariates and study how to develop a valid statistical inference procedure. An example concerning an asthma trial is presented for illustration.

Algorithms↗

PubMed2001

Improved antibody coating protocol using a second antibody antiserum. Application to total thyroxin immunoassay.

A complete antibody coating protocol for the preparation of dry antibody coated tubes is presented. This protocol is based on a recently described antibody immobilization principle. We modify this immobilization principle in order to improve and simplify the coating procedure. In addition, we propose a drying procedure that provides long-term storage stability of the antibody coated tubes. According to the modified protocol, polystyrene plastic tubes are first coated with rabbit gamma-globulins. The tubes are incubated with a sheep anti-rabbitIgG antiserum dilution. After incubation, antigen-specific antibody antiserum raised in rabbits is added directly into the tubes containing the sheep anti-rabbit IgG antiserum solution (difference from the original protocol). Finally, the tubes are washed, blocked, and dried following the drying procedure developed. The suitability of the modified protocol for the development of immunoassays requiring high loading of antibody was exemplified through the development of a RIA for total thyroxin. The estimated assay characteristics (detection limit 4 microg/L, dynamic range up to 210 microg/L, within-run CV 2.7-5.7%, between-run CV 5.1-7.3%, recovery 84.4-112%, cross-reactivity for T3 1.9%) were comparable with those provided by commercially available RIA kits for the determination of thyroxin.

Animals↗