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PubMed1992

Programmed electrical stimulation of the ventricle: an efficient, sensitive, and specific protocol.

A relatively simple and efficient ventricular programmed electrical stimulation (PES) protocol was developed, capable of achieving high degrees of sensitivity and specificity. In a series of 481 subjects, 1, 2, and 3 extrastimuli (ES) were used successively during sinus rhythm and ventricular pacing at two drive cycle lengths, at one or more ventricular sites, together with rapid ventricular pacing, and other maneuvers such as isoproterenol infusion. Three ES were used immediately after two ES at each drive rate, rather than returning after completion of the protocol with two ES. Using the protocol, appropriate arrhythmias could be induced in 88% of all patients with ventricular fibrillation, 84% of all patients with sustained ventricular tachycardia (91% with underlying coronary disease), and 58% of patients with severe nonsustained ventricular tachycardia. There were significant differences in inducibility between patients whose ventricular arrhythmias were due to coronary artery disease and other causes. In contrast, sustained ventricular arrhythmias (all ventricular fibrillation) could be induced in only 5% of a control group of control patients, for a specificity of 95%. The protocol described is simpler and more efficient than those that use exhaustive testing of two ES before going to three ES. Three ES during sinus rhythm proved to be the most productive step, with a higher yield ratio (true: false-positives) than two ES or three ES during pacing, especially at faster rates. Greater efficiency is also achieved by leaving the timing of an extrastimulus just beyond its effective refractory period when an additional extrastimulus is to be added, compared to protocols in which the extrastimulus is moved later in the cycle and then decremented in tandem with the additional extrastimulus. Coupling intervals less than 200 msec produced some false-positives, but fewer overall than intervals greater than or equal to 200 msec, and with yield ratios comparable to other protocol steps. The protocol described meets NASPE standards for ventricular programmed stimulation protocols, and with its demonstrated specificity and relative simplicity and efficiency may be useful as a model for groups not yet committed to an alternative protocol.

Cardiac Pacing, Artificial↗

PubMed1991

Use of a reamplification protocol improves sensitivity of detection of Mycobacterium tuberculosis in clinical samples by amplification of DNA.

We have compared the sensitivity and specificity of quantitative mycobacterial culture against results obtained by using the polymerase chain reaction for the detection of DNA from organisms of the Mycobacterium tuberculosis complex in 82 clinical specimens from patients suspected of having tuberculosis. Two amplification protocols were used, a standard amplification protocol, which amplifies a segment of the gene coding for the 65-kDa antigen, and a protocol in which the initial amplification products are reamplified with a second set of nested oligonucleotide primers. Although the standard amplification protocol gave positive results for 18 of 18 samples which grew greater than 100 CFU/ml and gave positive results in 4 of 35 specimens from patients with tuberculosis which were negative by culture, only 1 of 6 samples which grew less than 100 CFU/ml was positive. This lack of sensitivity could not be explained by the presence of inhibitors of Taq polymerase present in the original samples. In contrast, the reamplification protocol gave positive results for 24 of 24 samples which were positive by culture as well as for 13 of 35 samples from patients with tuberculosis which were negative by culture (overall sensitivity, 63%, P less than 0.02, compared with the standard amplification protocol and routine culture). Two of 23 samples from patients not diagnosed as having tuberculosis gave positive results when the standard amplification protocol was used, but no additional false-positive results were seen with the reamplification protocol (overall specificity, 91%). We conclude that the use of a reamplification protocol improves the sensitivity of detection of mycobacterial DNA in clinical samples without sacrificing specificity. The sensitivity of this approach appears to be superior to that of standard culture techniques.

Base Sequence↗

PubMed2005

Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study.

OBJECTIVES: To compare how allocation concealment is described in publications of randomised clinical trials and corresponding protocols, and to estimate how often trial publications with unclear allocation concealment have adequate concealment according to the protocol. DESIGN: Cohort study of 102 sets of trial protocols and corresponding publications. SETTING: Protocols of randomised trials approved by the scientific and ethical committees for Copenhagen and Frederiksberg, 1994 and 1995. MAIN OUTCOME MEASURES: Frequency of adequate, unclear, and inadequate allocation concealment and sequence generation in trial publications compared with protocols, and the proportion of protocols where methods were reported to be adequate but descriptions were unclear in the trial publications. RESULTS: 96 of the 102 trials had unclear allocation concealment according to the trial publication. According to the protocols, 15 of these 96 trials had adequate allocation concealment (16%, 95% confidence interval 9% to 24%), 80 had unclear concealment (83%, 74% to 90%), and one had inadequate concealment. When retrospectively defined loose criteria for concealment were applied, 83 of the 102 trial publications had unclear concealment. According to their protocol, 33 of these 83 trials had adequate allocation concealment (40%, 29% to 51%), 49 had unclear concealment (59%, 48% to 70%), and one had inadequate concealment. CONCLUSIONS: Most randomised clinical trials have unclear allocation concealment on the basis of the trial publication alone. Most of these trials also have unclear allocation concealment according to their protocol.

Cohort Studies↗

PubMed1997

Gas exchange and cardiovascular kinetics with different exercise protocols in heart transplant recipients.

Metabolic and cardiovascular adjustments to various submaximal exercises were evaluated in 82 heart transplant recipients (HTR) and in 35 control subjects (C). HTR were tested 21.5 +/- 25.3 (SD) mo (range 1.0-137.1 mo) posttransplantation. Three protocols were used: protocol A consisted of 5 min of rectangular 50-W load repeated twice, 5 min apart [5 min rest, 5 min 50 W (Ex 1), 5 min recovery, 5 min 50 W (Ex 2)]; protocol B consisted of 5 min of rectangular load at 25, 50, or 75 W; protocol C consisted of 15 min of rectangular load at 25 W. Breath-by-breath pulmonary ventilation (VE), O2 uptake (VO2), and CO2 output (VCO2) were determined. During protocol A, beat-by-beat cardiac output (Q) was estimated by impedance cardiography. The half times (t1/2) of the on- and off-kinetics of the variables were calculated. In all protocols, t1/2 values for VO2 on-, VE on-, and VCO2 on-kinetics were higher (i.e., the kinetics were slower) in HTR than in C, independently of workload and of the time post-transplantation. Also, t1/2 Q on- was higher in HTR than in C. In protocol A, no significant difference of t1/2 VO2 on- was observed in HTR between Ex 1 (48 +/- 9 s) and Ex 2 (46 +/- 8 s), whereas t1/2 Q on- was higher during Ex 1 (55 +/- 24 s) than during Ex 2 (47 +/- 15 s). In all protocols and for all variables, the t1/2 off-values were higher in HTR than in C, In protocol C, no differences of steady-state VE, VO2, and VCO2 were observed in both groups between 5, 10, and 15 min of exercise. We conclude that 1) in HTR, a "priming" exercise, while effective in speeding up the adjustment of convective O2 flow to muscle fibers during a second on-transition, did not affect the VO2 on-kinetics, suggesting that the slower VO2 on- in HTR was attributable to peripheral (muscular) factors; 2) the dissociation between Q on- and VO2 on-kinetics in HTR indicates that an inertia of muscle metabolic machinery is the main factor dictating the VO2 on-kinetics; and 3) the VO2 off-kinetics was slower in HTR than in C, indicating a greater alactic O2 deficit in HTR and, therefore, a sluggish muscle VO2 adjustment.

Adolescent↗

PubMed2006

One-shock versus three-shock defibrillation protocol significantly improves outcome in a porcine model of prolonged ventricular fibrillation cardiac arrest.

BACKGROUND: The success of resuscitation with a 1-shock versus the conventional 3-shock defibrillation protocol was investigated subject to the range of treatment variation imposed by automated external defibrillators (AEDs). METHODS AND RESULTS: Ventricular fibrillation was induced in 44 domestic pigs. After 7 minutes of untreated VF, animals were randomized among 4 groups representing all combinations of the 1- versus 3-shock protocol and 2 different AED regimens (AED1, AED2). Because few AEDs support a 1-shock protocol, manual defibrillators were used to replicate the AED treatment regimen: electrical waveform, dose sequence, and cardiopulmonary resuscitation (CPR) interruption intervals. Initial shock(s) were delivered, followed by 60 seconds of CPR, and the treatment was repeated until resuscitation was successful or for 15 minutes. The 1-shock protocol was associated with improved outcome, reducing CPR interruptions from 45% to 34% of total resuscitation time (P=0.019) and increasing survival from 64% to 100% (P=0.004). Survival was 91% for AED1 versus 36% for AED2 (P=0.024) with a 3-shock protocol but was increased to 100% for both by adoption of a 1-shock protocol. Improvements in postresuscitation left ventricular ejection fraction and stroke volume were observed with AED1 compared with AED2 (difference of means, 15% and 28% of baseline respectively, P<0.001) regardless of defibrillation protocol. CONCLUSIONS: Adoption of a 1-shock versus a 3-shock resuscitation protocol improved survival and minimized outcome differences imposed by variations in AED design and implementation. When a conventional 3-shock defibrillation protocol was used, however, the choice of AED had a significant impact on resuscitation outcome.

Animals↗

PubMed2003

Physiological responses using 2 high-speed resistance training protocols.

This study compared physiological responses to 2 high-speed resistance training (RT) protocols in untrained adults. Both RT protocols included 12 repetitions for the same 6 exercises, only differing in continuous (1 x 12) or discontinuous (2 x 6) mode. For discontinuous mode, there was a 15-second rest interval between sets. We hypothesized that the 2 x 6 protocol was less physiologically demanding than the 1 x 12 protocol. Fifteen untrained adults randomly performed the protocols on 2 different days while heart rate (HR), blood lactate (BL), rate of perceived exertion (RPE), and concentric phase mean power (CPMP) were measured. Significantly lower values (mean +/- SE) were seen with the discontinuous protocol for exercise HR (119 +/- 5 vs. 124 +/- 5 b x min(-1)), BL (5.7 +/- 0.5 vs. 6.7 +/- 0.3 mMol/L), and RPE (5.4 +/- 0.3 vs. 5.8 +/- 0.4) (p < 0.05). CPMP tended to be higher in the discontinuous protocol, especially for the 2 last repetitions. The discontinuous protocol was significantly less physiologically demanding, although similar or higher CPMP values were obtained. These findings may help foster long-term adherence to RT in untrained individuals. However, future studies are needed to compare physiological adaptations induced by these 2 RT protocols.

Adult↗

PubMed2002

Effect of an imaging protocol on clinical outcomes among pediatric patients with appendicitis.

OBJECTIVE: In 1998, we implemented a clinical imaging protocol in which children with suspected appendicitis underwent ultrasonography (US) followed by computed tomography (CT). We sought to determine the impact of the US-CT protocol on changes in perforation and negative appendectomy rates. METHODS: Children with unequivocal presentations for appendicitis went to the operating room without entering the imaging protocol. Using a modified time series design, we analyzed a prospective and retrospective cohort of consecutive patients who were admitted from the emergency department for suspected appendicitis. The perforation and negative appendectomy rates were computed for the periods before and after implementation of the imaging protocol and adjustment for time trends was made. RESULTS: A total of 1338 children were identified. Eight hundred ten (60.5%) children had equivocal clinical findings. A total of 920 patients were admitted for suspected appendicitis before the protocol was implemented; 526 (57.2%) of the 920 children had appendicitis, and 186 (35.4%) of them had perforation. A total of 91 (14.7%) of 617 had negative appendectomies. After the protocol was implemented, 418 patients were admitted for suspected appendicitis; 328 (78.5%) had appendicitis with 51 (15.5%) perforated. There were 14 (4.1%) of 342 cases of negative appendectomies. After implementation of the imaging protocol, the perforation rate decreased from 35.4% to 15.5%, and the negative appendectomy rate decreased from 14.7% to 4.1%. After secular time trends were adjusted for, the imaging protocol continued to have a strong association with a reduction in perforation rate and negative appendectomy rate. CONCLUSION: The implementation of an imaging protocol using US and CT resulted in a marked decrease in the perforation and negative appendectomy rates in children with suspected appendicitis.

Adolescent↗

PubMed1998

The problem of protocol driven costs in pharmacoeconomic analysis.

The increasing number of economic evaluations of healthcare interventions and of drug therapies in particular has been well documented. Surveys of the quality of studies have demonstrated that standards of conduct of such studies have not similarly increased. Concerns over the standards have led to increased calls that economic analyses be more closely linked to randomised controlled clinical trials (RCT). Seven potential threats to the external validity of results limit the generalisability of studies based on RCTs. One such threat is the existence of protocol driven costs. There are two main types of protocol driven costs. Protocol prescribed costs arise as a result of resource use mandated by the clinical trial design. Protocol derived costs occur when increased clinical investigations mandated by trial protocols lead to atypical disease management. Methods to control for protocol driven costs within pharmacoeconomic study designs are available. Modelling studies can be based on data within clinical trials combined with observational data representing more typical resource use. The adoption of pragmatic clinical trial designs provide greater external validity though reduced internal validity. Refinements to explanatory clinical trials can also lead to reduced protocol driven costs. The extent that current studies control for such costs is unclear due to the lack of transparency in the reporting of study methods. A review of published studies found little consideration of protocol driven costs although in several studies there was evidence of their existence. Future studies conducted alongside RCTs should explicitly address how the issue of protocol driven costs was handled within the study framework.

Economics, Pharmaceutical↗

PubMedDate not supplied

Wireless access to a pharmaceutical database: a demonstrator for data driven Wireless Application Protocol (WAP) applications in medical information processing.

BACKGROUND: The Wireless Application Protocol technology implemented in newer mobile phones has built-in facilities for handling much of the information processing needed in clinical work. OBJECTIVES: To test a practical approach we ported a relational database of the Danish pharmaceutical catalogue to Wireless Application Protocol using open source freeware at all steps. METHODS: We used Apache 1.3 web software on a Linux server. Data containing the Danish pharmaceutical catalogue were imported from an ASCII file into a MySQL 3.22.32 database using a Practical Extraction and Report Language script for easy update of the database. Data were distributed in 35 interrelated tables. Each pharmaceutical brand name was given its own card with links to general information about the drug, active substances, contraindications etc. Access was available through 1) browsing therapeutic groups and 2) searching for a brand name. The database interface was programmed in the server-side scripting language PHP3. RESULTS: A free, open source Wireless Application Protocol gateway to a pharmaceutical catalogue was established to allow dial-in access independent of commercial Wireless Application Protocol service providers. The application was tested on the Nokia 7110 and Ericsson R320s cellular phones. CONCLUSIONS: We have demonstrated that Wireless Application Protocol-based access to a dynamic clinical database can be established using open source freeware. The project opens perspectives for a further integration of Wireless Application Protocol phone functions in clinical information processing: Global System for Mobile communication telephony for bilateral communication, asynchronous unilateral communication via e-mail and Short Message Service, built-in calculator, calendar, personal organizer, phone number catalogue and Dictaphone function via answering machine technology. An independent Wireless Application Protocol gateway may be placed within hospital firewalls, which may be an advantage with respect to security. However, if Wireless Application Protocol phones are to become effective tools for physicians, special attention must be paid to the limitations of the devices. Input tools of Wireless Application Protocol phones should be improved, for instance by increased use of speech control.

Clinical Pharmacy Information Systems↗

PubMed2004

Peer-review and publication of research protocols and proposals: a role for open access journals.

Peer-review and publication of research protocols offer several advantages to all parties involved. Among these are the following opportunities for authors: external expert opinion on the methods, demonstration to funding agencies of prior expert review of the protocol, proof of priority of ideas and methods, and solicitation of potential collaborators. We think that review and publication of protocols is an important role for Open Access journals. Because of their electronic form, openness for readers, and author-pays business model, they are better suited than traditional journals to ensure the sustainability and quality of protocol reviews and publications. In this editorial, we describe the workflow for investigators in eHealth research, from protocol submission to a funding agency, to protocol review and (optionally) publication at JMIR, to registration of trials at the International eHealth Study Registry (IESR), and to publication of the report. One innovation at JMIR is that protocol peer reviewers will be paid a honorarium, which will be drawn partly from a new submission fee for protocol reviews. Separating the article processing fee into a submission and a publishing fee will allow authors to opt for "peer-review only" (without subsequent publication) at reduced costs, if they wish to await a funding decision or for other reasons decide not to make the protocol public.

Access to Information↗

PubMed1993

Comparison of bolus and infusion protocols for determining acute insulin response to intravenous glucose in normal humans. The ICARUS Group. Islet Cell Antibody Register User's Study.

OBJECTIVE: To help standardize methodology for intravenous glucose tolerance testing in preclinical IDDM by comparing a 30-s bolus and a 3-min infusion of glucose. RESEARCH DESIGN AND METHODS: We tested 20 healthy nondiabetic adults at four centers (in Seattle, Boston, Melbourne, and London). Each subject had four intravenous glucose tolerance tests (two bolus and two infusion). The acute insulin response to glucose was calculated as the mean of the 1' + 3', the mean of 1' to 10', or as the integrated area from 0 to 10'. Glucose and insulin profiles and intrasubject coefficient of variation were compared. RESULTS: With the infusion protocol, the 1' insulin was significantly higher, resulting in a higher acute insulin response to glucose when calculated as 1' + 3' (525 +/- 66 vs. 376 +/- 35 pM, P < 0.004). When calculated over 10 min, however, the acute insulin response to glucose was not different between protocols. In addition, the intrasubject coefficient of variation was significantly better when calculated over 10 min in both protocols, but no significant differences were noted between the bolus and infusion (infusion: AIRg [area from 0 to 10'] 10.4 +/- 2.1% vs. AIRg [1' + 3'] 14.9 +/- 2.8%, P < 0.007; bolus: AIRg [area from 0 to 10'] 14.6 +/- 2.8% vs. AIRg [1' + 3'] 19.8 +/- 3.5%, P < 0.007). Comparison of the insulin assays between the four centers showed close correlation and gave indistinguishable results in terms of within-subject coefficient of variation. Glucose profiles were similar in both protocols. Although the glucose values were lower with the bolus protocol from 4' to 40', the rate of fall from 10 to 30' (and thus the rate of glucose disposal) was indistinguishable between the two. CONCLUSIONS: These data suggest that neither protocol gives significant advantage over the other. However, to allow comparison of the acute insulin response to glucose between different protocols used in centers around the world, the ICARUS 3-min infusion protocol is recommended, with acute insulin response to glucose calculated over 10 min after the end of glucose administration; this reduces the within-subject coefficient of variation and provides similar acute insulin response to glucose with both protocols.

Adult↗

PubMed2001

Calf removal improves conception rates to the Ovsynch and CO-Synch protocols.

Beef cows (n = 473) from two locations were stratified by breed, postpartum interval, age, and AI sire and were randomly allotted to one of four treatments for synchronization of ovulation. Ovulation synchronization protocols included the Ovsynch protocol with (n = 114) or without (n = 123) 48-h calf removal from d 7 to 9 (d 0 = 1st GnRH injection) or the CO-Synch protocol with (n = 119) or without (n = 117) 48-h calf removal from d 7 to 9. The Ovsynch protocol included administration of GnRH (100 microg; i.m.) on d 0, PGF2alpha (25 mg; i.m.) on d 7, GnRH (100 microg; i.m.) on d 9, and timed insemination on d 10. The CO-Synch protocol included administration of GnRH (100 microg; i.m.) on d 0, PGF2alpha (25 mg; i.m.) on d 7, and GnRH (100 microg; i.m.) with timed insemination on d 9. Blood samples were collected from all cows on d -10 and d 0 for analysis of serum progesterone. Cows with at least one serum progesterone concentration greater than 1 ng/mL were considered to be cyclic at the time of treatment. Conception rates of cows that received the CO-Synch + calf removal, Ovsynch + calf removal, CO-Synch, or Ovsynch protocol (63, 61, 54, and 52%, respectively) were not different (P = 0.50). Conception rates were not different (P = 0.80) among CO-Synch- and Ovsynch-treated cows; however, both estrual status and 48-h calf removal affected conception rates. Conception rates of cyclic cows (66%) were greater (P = 0.01) than those of anestrous cows (53%), regardless of which synchronization protocol was used. When data were pooled across synchronization protocol, conception rates of cows with 48-h calf removal (62%) were greater (P = 0.09) than conception rates of cows without calf removal (53%). The CO-Synch + calf removal protocol induces a fertile ovulation in cyclic and anestrous cows, requires handling cattle just three times, results in high conception rates from timed insemination, and should be a useful program for synchronization of ovulation in beef cows.

Anestrus↗

PubMed1997

Clinical evaluation of three different loudness scaling protocols.

Loudness scaling has recently attracted much attention as a valuable clinical tool for acquiring reliable knowledge about loudness perception. This information can be used for diagnostic and rehabilitative purposes. In this study a loudness scaling module implemented in a new PC-based audiological test system was comprehensively tested. The system has proven to be a reliable and useful tool in a clinical environment. The described 'Default' loudness scaling protocol seems to represent an appropriate set of parameters. A comparison between this protocol and two other protocols available for clinical use indicates that the 'Default' protocol presents the same consistency of subject response as the 'IHAFF' protocol, and a better consistency than the 'LGOB' protocol. Regarding time consumption, the 'Default' protocol is superior to the 'IHAFF' protocol and comparable to the 'LGOB' protocol.

Audiometry, Pure-Tone↗

PubMedDate not supplied

Adolescent preventive health visits: a comparison of two invitation protocols.

BACKGROUND: Adolescent health care in family practice at times creates conflicting responsibilities for parents and their teenagers. In the context of a new adolescent preventive health program in a family practice setting, we compared attendance rates using two invitation protocols, the protocols differing in their emphasis on adolescent autonomy vs parental responsibility. METHODS: One hundred six teenagers in the seventh and tenth grades were invited for preventive health visits with the family nurse and physician using two protocols. Protocol 1 involved obtaining parental consent before approaching the adolescent. With protocol 2, an invitation letter and parental consent form were mailed to the teenager, while a letter of explanation was sent concurrently to the parents. In each case, the letter of invitation was followed up by a telephone call for those who did not respond. The spontaneous response rate (a positive response after receiving the letter), agreement to attend rate (a positive response after receiving the letter or being telephoned), and the attendance rate were determined according to grade, sex, and protocol. RESULTS: The spontaneous response rate was 21%, the agreement to attend rate was 75%, and the attendance rate was 44%. Attendance rates were higher for the girls compared with the boys (54% vs 35%, P = .08) and for the seventh graders compared with the tenth graders (53% vs 31%, P = .03). The spontaneous response rate was lower among the tenth graders using protocol 2 (8% vs 37.5% with protocol 1, P = .04), while the agreement to attend rate and attendance rate did not differ for the two protocols. CONCLUSIONS: Nearly one half of this population of adolescents attended preventive health visits at the family nurse's and physician's initiative. A follow-up telephone call after the initial written invitation resulted in increased participation, while approaching the teenager or parent initially did not make a difference in attendance. This pilot study shows the potential for initiating an adolescent health program in the family practice setting.

Adolescent↗

PubMed1997

Evaluation of different protocols for prostaglandin synchronization to improve reproductive performance in dairy herds with low estrus detection efficiency.

The objective of this study was to evaluate different PGF2 alpha protocols against control protocols for herds with estrus detection efficiencies of 35, 55, and 75% using modeling and simulation: 1) PGF2 alpha treatments based on the presence of a corpus luteum diagnosed by rectal palpation, 2) PGF2 alpha treatments based on the presence of a corpus luteum diagnosed by an on-farm milk progesterone enzyme immunoassay, and 3) PGF2 alpha treatments based on a 14-d fixed treatment schedule without prior screening for ovarian status. After the start of each protocol, estrus detection efficiency was 75% for 7 d after treatment and 35 or 0% for the following week. For the third protocol, an additional modification at estrus detection efficiencies of 85 and 55%, respectively, in the 1st and 2nd wk after treatment was evaluated to establish a protocol for best case assumptions. All protocols improved reproductive performance relative to that of controls with estrus detection efficiencies of 35 and 55%. The mean number of days open was reduced from 124.3 d in the control herd to 95.9, 95.0, and 92.7 for the protocols based on rectal palpation, milk progesterone test, and the fixed treatment schedule, respectively. The protocols based on a fixed treatment schedule were superior to protocols based on rectal palpation and on-farm milk progesterone tests and resulted in better reproductive performance and a higher increase in net return per cow per year. Relative to a control herd with an estrus detection efficiency of 55%, it was cost effective to spend up to $10 per dose of PGF2 alpha, $9 per milk progesterone test, and $6 per rectal palpation.

Animals↗

PubMedDate not supplied

Description and evaluation of a glycemic management protocol for patients with diabetes undergoing heart surgery.

OBJECTIVE: To evaluate a protocol for glycemic management in the treatment of postoperative heart patients with diabetes in the setting of a community hospital. METHODS: The protocol included a standardized guideline in tabular form for nurse-implemented insulin infusion ("drip") therapy for postoperative glycemic control. At the time of discontinuation of the insulin drip, the glycemic status of patients with diabetes was managed by the endocrine department. Overall, 29 patients were assessed without and 29 patients with use of the protocol in a community hospital. RESULTS: From postoperative days 0 through 4, use of the protocol resulted in a greater number of blood glucose determinations, a trend toward greater utilization of insulin drip therapy without a significant increase in the number of patients treated with insulin drip, and no change in the frequency of hypoglycemic episodes. During the same time interval, the percentages of postoperative days during which at least one blood glucose value equaled or exceeded 250 mg/dL were 27.5% without the protocol and 16.8% with use of the protocol (P = 0.0318). The principal finding of the study was reduction in the percentage of postoperative days during which mean blood glucose values equaled or exceeded 200 mg/dL to less than half the previously observed frequency-from 38.4% without the protocol to 16.8% with the protocol (P = 0.0001). The effectiveness of the insulin drip component of the protocol is suggested by a trend, shown on postoperative days 2 through 4, of 70 patient days with mean blood glucose levels <200 mg/dL (58 of these days without insulin drip therapy) and 15 patient days with mean blood glucose values > or =200 mg/dL (none of these days associated with same-day insulin drip therapy). CONCLUSION: A standardized approach to insulin drip therapy, in combination with subspecialty consultation for follow-up glycemic management with use of subcutaneous administration of insulin, can improve glycemic control in postoperative heart patients without continuation of insulin drip therapy outside the critical-care unit. The trends observed on postoperative days 2 through 4, that most patients maintained glycemic control without insulin drip therapy and that all failures of glycemic control occurred among patients who no longer received insulin drip therapy, suggest the possibility of developing criteria for selection of patients for continuation of insulin infusion outside the critical-care unit.

Aged↗

PubMed2001

Three protocols for monitoring follicle development in 587 unstimulated cycles of in vitro fertilization and intracytoplasmic sperm injection. A comparison.

OBJECTIVE: To test the adequacy of unstimulated cycles for intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF) and to evaluate implantation and pregnancy rates in three monitoring protocols. STUDY DESIGN: A retrospective chart review of 587 patients undergoing IVF and ICSI in unstimulated cycles was performed. In the first group (protocol A), all cycles were monitored by ultrasound only. Human chorionic gonadotropin (hCG) was given when the mean follicle diameter reached 18 mm. In protocol B, hCG was given when serum estradiol (E2) or follicle diameter reached the critical value (0.91 nmol/L and 18 mm). With a smaller follicle diameter, the E2 level had to be higher, and vice versa. In protocol C, hCG was administered when the serum E2 was > 0.49 nmol/L and follicle diameter at least 15 mm. Cycles with positive luteinizing hormone in urine before hCG was given were cancelled. RESULTS: The cancellation rate was lower in protocol C (33/335, 9.8%) than protocol B (42/151, 27.8%) and A (41/101, 40.5%). In protocol C the pregnancy rate per cycle was higher with IVF (n = 219) and ICSI (n = 116) cycles (10.5% and 12.1%) than when protocol B was used (3.8% and 4.3%). The pregnancy rate per transfer was highest when protocol C was used in the IVF (23/105, 21.9%) and ICSI group (14/53, 26.4%). CONCLUSION: Unstimulated cycles monitored by serum E2, urinary luteinizing hormone and ultrasound can produce an acceptable pregnancy rate after IVF and ICSI.

Adult↗

PubMed2003

Standardizing contact investigation protocols.

SETTING: The State of Alabama Department of Public Health Division of Tuberculosis Control. OBJECTIVE: To standardize contact investigation protocols and implement an intervention to increase TB field worker adherence to the protocols with the goal of promoting efficiency and effectiveness in contact investigations. DESIGN: A process evaluation of existing data collection and management systems and protocols was performed. Standardized protocols and an intervention to increase TB field worker adherence to the protocols were created and pilot tested. These were then implemented and formative evaluation data were collected. RESULTS: The process evaluation revealed considerable variance among field workers with regard to protocols and definitions of variables related to contact investigations. Protocols were standardized and an intervention targeted at TB field workers was developed. The intervention consisted of a training workshop and the development of a computer-based contact investigation module. This was successfully implemented throughout the state. CONCLUSIONS: To perform effective contact investigations and conduct studies to improve the effectiveness of these investigations, TB control programs must pay careful attention to precisely defining variables and concepts related to the contact investigation. Furthermore, protocols must be standardized and resources devoted to training of TB field workers to ensure adherence to protocols.

Alabama↗