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PubMedDate not supplied

[Changes in blood coagulation in treatment with ALL-BFM-90 and NHL-BFM-90 protocols].

1. Treatment according to the ALL/NHL-BFM 90 protocol I (induction phase) caused multiple and severe coagulation changes in all 14 patients of our study. Glucocorticoids alone made Fibrinogen drop to 148 mg/dl, AT III and Protein C rise to 136% or even 179% respectively. After day 12, immediately following the start of therapy with Coli-Asparaginase (ASP), fibrinogen continued to drop to reach its lowest average value of 46 mg/dl on day 24. Anticoagulant factors like plasminogen (lowest average value: 36%), AT III (47%) and Protein C (93%) dropped abruptly. These alterations were reversed after discontinuation of Glucocorticoids and ASP. During consolidation (protocol II) similar alterations are observed as in protocol I when Glucocorticoids are applied alone. However, after Erwinia-ASP there is no fall in AT III, plasminogen, and Protein C as is observed in protocol I with Coli-ASP. 2. Severe hemorrhages or thromboses are uncommon as compared to the degree of coagulation changes which can be regularly observed. Complications occur more often in girls. Most of them are seen during the 2nd or 3rd week of simultaneous ASP-Glucocorticoid therapy. 3. To avoid twofold alteration of hemostasis it should be considered to apply Glucocorticoids and ASP separately and to replace Coli-ASP by Erwinia-ASP. The efficacy of prophylactic replacement of decreased coagulation factors has not yet been confirmed. Immunologic and infectious side effects have to be taken into consideration. 4. More definite recommendations can be given when each suspected bleeding and/or thrombosis is confirmed by imaging procedures, when it is documented and registered, and when coagulation studies are performed during the critical phase.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2003

Efficacy and time-efficiency of a "sonographer-driven" contrast echocardiography protocol in a high-volume echocardiography laboratory.

BACKGROUND: Contrast echocardiography (CE) has not gained widespread use despite numerous studies demonstrating its efficacy in the assessment of left ventricular (LV) function. METHODS: We sought to determine whether CE could be used in a high-volume echocardiography laboratory in a clinically effective and time efficient manner. We implemented a protocol with a feasibility phase and an established phase. Cost-benefit analyses were done on the basis of time use. RESULTS: During the feasibility and established phases, data on 119 and 672 patients, respectively, were obtained. After a "sonographer-driven" protocol, contrast studies represented 7% to 8% of the total number of routine transthoracic and stress studies. Stress studies accounted for only 15% of the total number of contrast studies. Obesity was the most common indication for contrast use. LV visualization indices and wall thickening assessment, as evaluated by 2 blinded readers, were significantly improved with CE compared with second harmonic imaging alone. The time to make the decision to use CE and the time taken to administer contrast decreased significantly from the feasibility phase to the established phase (8.3 +/- 5 vs 7.6 +/- 5 min, P <.01, and 13.4 +/- 10 vs 10.2 +/- 5 min, P <.001, respectively). On the basis of time use only, a cost analysis indicated that savings were obtained at a 10-minute reduction in study time. CONCLUSIONS: A "sonographer-driven" CE protocol for LV assessment is feasible in high-volume echocardiography laboratories. It is clinically effective because it significantly improves LV global and regional wall motion visualization. A "sonographer-driven" CE protocol can reduce decision and administration times substantially, thus making CE time-efficient.

Albumins↗

PubMed2001

Evaluation of a screening protocol to exclude the diagnosis of deep venous thrombosis among emergency department patients.

OBJECTIVE: The purpose of this study was to evaluate the efficacy and cost effectiveness of a deep venous thrombosis (DVT) screening protocol incorporating DVT pretest probability (PTP), selective D-dimer assay, and venous duplex imaging (VDI) to exclude the diagnosis of DVT among emergency department (ED) patients. METHODS: A prospective study of all patients evaluated in the ED for suspected DVT during 1 year was undertaken. Patients were classified into PTP risk category by ED physicians before VDI. Correlation studies were completed using VDI as the gold standard. Charges associated with the protocol were calculated. RESULTS: One hundred fourteen patients were included. The incidence of DVT was 9.6% (11). Thirty-six (55%) patients were classified as high risk, 23 (35%) as moderate, and 7 (10%) as low risk. All patients diagnosed with DVT were in the high-risk group (incidence, 16.7%). The sensitivity and negative predictive value were both 100% when PTP and D-dimer were used, but fell to 80% and 95%, respectively, when only D-dimer was considered. The true negative rates were 23% and 37%, respectively. Based on this study, we propose the following screening: for high-risk patients, use direct VDI (no D-dimer); for low-risk or moderate-risk patients, obtain D-dimer, and if it is positive, use VDI, and if it is negative, no further action is required. The average charge associated with the protocol was 170.50 dollars as opposed to 202.00 dollars for global VDI. CONCLUSION: A screening protocol using PTP along with selective D-dimer and VDI to exclude the diagnosis of DVT among ED patients is efficacious and cost efficient. This screening approach establishes criteria to satisfy billing requirements, can eliminate unnecessary VDI in 23% of ED referrals, and can reduce charges by 16%.

Adult↗

PubMed2003

Country-wide availability of paediatric medical protocols via the local hospital intranet site.

In paediatrics, a wide variety of procedures and interventions (protocols) are standardized. The entire hard-copy collection of paediatric protocols used in Malta (47 to date) was put together as a website, and is hosted on the hospital intranet. Some protocols consist of Excel spreadsheets that are used for the calculation of fluids and drugs. This archive has proved very useful for medical and paramedical staff in the Department of Paediatrics, both in the hospital and in peripheral health centres and hospitals. Changes or new protocols may be uploaded at any time, with instantaneous updating of the archive. The website was created, and is maintained and updated by the author, thanks to the ease with which modern software allows users to create hypertext markup language.

Archives↗

PubMedDate not supplied

Hospital follow-up of patients categorized as not needing an ambulance using a set of emergency medical technician protocols.

OBJECTIVE: Using hospital outcomes, this study evaluated emergency medical technicians' (EMTs') ability to safely apply protocols to assign transport options. METHODS: Protocols were developed that categorized patients as: 1) needs ambulance; 2) may go to emergency department (ED) by alternative means; 3) contact primary care provider (PCP); or 4) treat and release. After education on application of the protocols, EMTs categorized patients at the scene prior to transport but did not change current practice. Hospital charts were reviewed to determine outcome of patients whom EMTs categorized as not needing an ambulance. Category 2 patients were assumed to need the ambulance if they were admitted to a monitored bed or intensive care unit. Category 3 and 4 patients were assumed to need the ED if they were admitted. RESULTS: The EMTs categorized 1,300 study patients: 1,023 (79%) ambulance transport, 200 (15%) alternative means, 63 (5%) contact PCP, and 14 (1%) treat and release. Hospital data were obtained for 140 (51%) patients categorized as not needing ambulance transport. Thirteen of 140 (9%) patients who transporting EMTs determined did not need the ambulance were considered to be undertriaged: five in category 2, six in category 3, and one in category 4. Six of 13 (46%) undertriaged patients had dementia or a psychiatric disorder as one of their presenting complaints. CONCLUSION: These protocols led to a 9% undertriage rate. Patients with psychiatric complaints and dementia were at high risk for undertriage.

Adult↗

PubMedDate not supplied

EMS provider findings and interventions with a statewide EMS spine-assessment protocol.

OBJECTIVE: To describe the utilization and findings with a statewide, prehospital spine-assessment protocol for emergency medical services (EMS) providers in a rural state. METHODS: The study was a prospective sample of EMS patients evaluated by prehospital providers for trauma-related injury during a one-year investigation period. Prehospital providers prospectively completed supplementary spine data-collection forms that reported patient demographics and EMS provider findings with the spine-assessment protocol. Data were analyzed using descriptive statistics. RESULTS: There were 207,545 EMS encounters during the study period, including 31,885 transports for acute trauma-related illness. Prehospital providers provided spine-assessment forms for 2,220 patient encounters. Providers reported a decision to immobilize 1,301 (59%) patients. For these immobilized patients, spine protocol findings included 416 (32%) patients deemed as unreliable, 358 (28%) with distracting injury, 80 (6%) with an abnormal neurologic examination, and 709 (54%) with spine pain or tenderness. Linkage of EMS and hospital data revealed seven acute spine fracture patients among the 2,220 reported encounters, all of whom were immobilized by EMS providers. CONCLUSIONS: Use of this prehospital spine-assessment protocol resulted in an EMS provider decision not to immobilize approximately 40% of EMS trauma patients. Few spine fracture patients were encountered during the investigational period, though all were immobilized.

Adult↗

PubMed2005

A respiratory therapist-directed protocol for managing inpatients with asthma and COPD incorporating a long-acting bronchodilator.

This prospective study was designed to determine whether incorporating formoterol into a standardized respiratory therapist-directed protocol for administering bronchodilators to hospitalized patients with obstructive airway disease would reduce health care resource use and provide a safety advantage. All patients admitted to Washington Hospital Center with asthma and chronic obstructive pulmonary disease (CODP) are administered bronchodilators under a standardized respiratory therapist-directed protocol. Formoterol was the primary bronchodilator for the intervention period from January through March 2002, with levalbuterol, albuterol, and ipratropium available as needed. Results for the intervention period were compared against two historical control periods. From January through March 2000, the bronchodilators in the protocol were albuterol and ipratropium, and from January through March 2001 levalbuterol, albuterol, and ipratropium were available. Health care resource use was determined by the number of bronchodilator treatments administered per admission. Costs (adjusted to 2002 dollars) for supplies, therapist time, and drugs were calculated for the three time periods. Adverse events related to bronchodilator administration were recorded in a standardized manner for all three time periods. Bronchodilator treatments per admission, respiratory therapist visits per admission, and time spent per admission, and cost per bronchodilator treatment significantly decreased in 2002. Significantly fewer adverse events related to bronchodilator treatments were reported in 2002 than 2000. The addition of formoterol to a respiratory therapist-directed protocol for administering bronchodilators reduced health care resource use and adverse events for patients with asthma and COPD.

Albuterol↗

PubMed1990

Feasibility and effects of a diabetes type II protocol with blood glucose self-monitoring in general practice.

A diabetes protocol characterized by self-monitoring of blood glucose was introduced in four general practices with the aim of making the frequency of consultations dependent on the metabolic regulation and emphasizing body weight reduction. The feasibility of the programme was investigated and the results after 1 year were compared with those of conventional care in four control practices. In the experimental practices, 13 patients switched from a medical specialist's to a general practitioner's supervision, 20 remained under supervision of their GP and 33 started self-monitoring. The self-monitoring rate, the consultation frequency according to protocol, the low number of dropouts and inadequate referrals and adherence to the therapeutic scheme showed that the protocol was feasible for both the GPs and the patients. At the initial assessment, the regulation of the diabetes was worse in patients of the experimental group, compared with those of the control group (mean HbA1 9.7% vs 8.9%; p less than 0.05). On average, patients in the experimental group (n = 56) lost 0.4 kg of body weight, whereas those in the control group (n = 73) gained 0.1 kg (n.s.). The mean change in HbA1, adjusted for the initial value, was -0.4% in the experimental and +0.5% in the control group (p less than 0.05). The results of the protocol can be attributed to a combination of greater participation of the patient, the individualized consultation frequency and the prescription of oral hypoglycaemic agents according to body weight development.

Administration, Oral↗

PubMed1998

Adjuvant 5-fluorouracil and leucovorin with or without interferon alfa-2a in colon carcinoma: National Surgical Adjuvant Breast and Bowel Project protocol C-05.

BACKGROUND: National Surgical Adjuvant Breast and Bowel Project (NSABP) protocol C-03 showed a benefit from leucovorin (LV)-modulated 5-fluorouracil (5-FU) adjuvant therapy (5-FU + LV) in patients with Dukes' stage B or C carcinoma of the colon. Preclinical and clinical phase I/II data suggested that interferon alfa-2a (IFN) enhanced the efficacy of 5-FU therapy. Accordingly, in NSABP protocol C-05, the addition of recombinant IFN to 5-FU + LV adjuvant therapy was evaluated. METHODS: Data are presented for 2176 patients with Dukes' stage B or C cancer entered onto protocol C-05 during the period from October 1991 through February 1994. Individuals with an Eastern Cooperative Oncology Group performance status of 0-2 (ranges from fully active to ambulatory and capable of self-care but unable to work), a life expectancy of at least 10 years, and curative resection were stratified by sex, disease stage, and number of involved lymph nodes and were randomly assigned to receive either 5-FU + LV or 5-FU + LV + IFN; the mean time on the study as of June 30, 1997, was 54 months. All statistical tests were two-sided. RESULTS: There was no statistically significant difference in either disease-free survival (5-FU + LV, 69%; 5-FU + LV + IFN, 70%) or overall survival (5-FU + LV, 80%; 5-FU + LV + IFN, 81%) at 4 years of follow-up. Toxic effects of grade 3 or higher were observed in 61.8% of subjects in the group treated with 5-FU + LV and in 72.1% of subjects in the group treated with 5-FU + LV + IFN; fewer patients in the latter group completed protocol-mandated 5-FU + LV therapy than in the former group (77.1% versus 88.5%). CONCLUSION: The addition of IFN to 5-FU + LV adjuvant therapy confers no statistically significant benefit, but it does increase toxicity.

Antimetabolites, Antineoplastic↗

PubMed1990

State health department response to disease cluster reports: a protocol for investigation.

State health departments are increasingly faced with the task of responding to reports of apparent cancer and other disease clusters. Since 1979, 141 requests for investigation have been received by the Wisconsin Division of Health, with over 60% of these requests occurring since 1985. Mounting public concern and limited resources have resulted in the development of a "disease cluster investigation and analysis protocol." Protocol steps include: 1) circumscribing the cluster; 2) ascertaining cases; 3) assessing risk of the exposed versus a referent population; 4) statistically analyzing disease rates; 5) examining potential exposure; 6) assessing biologic plausibility; 7) determining cluster significance and need for further investigation; and 8) reporting results. To demonstrate the protocol, the authors present a case example of an investigation of an apparent cancer cluster. Since 1979, 62 reports were resolved with initial contact with informant education (step 1), 61 reports required descriptive analysis (steps 1-8) with no site visit, and 18 reports required site visits. None of the reports required further in-depth epidemiologic investigation. This protocol provides a systematic approach to investigation and analysis, prioritizes the need for more in-depth study, and, when necessary, assuages community concerns when a disease cluster is reported.

Adolescent↗

PubMed1991

Multicentre study of the determination of peak oxygen uptake and ventilatory threshold during bicycle exercise in chronic heart failure. Comparison of graphical methods, interobserver variability and influence of the exercise protocol. The VO2 French Study Group.

Assessment of the ventilatory threshold (VT) has been proposed to assess exercise tolerance more objectively, particularly in clinical trials, but reproducibility, interobserver variability and feasibility of the graphical methods for determination of VT have not been properly studied in patients with chronic heart failure (CHF). Fifty-one patients with mild to moderate CHF (mean peak oxygen uptake (VO2): 20.5 ml.min-1.kg-1) were assessed during two consecutive bicycle exercise tests within 8 days. Two graded exercise protocols were compared with stages of 30 W every 3 min (22 patients) or 10 W/min (29 patients). VT was determined separately by five trained physicians using five different graphical methods. The 'crossing method' (first crossing of the VCO2 and VO2 curves) yielded the highest rate of determination (88%) but tended to overestimate the mean VT. The VE method (disproportionate increase of ventilation relative to VO2) produced the best interobserver agreement (coefficient of variation = 78%). Peak VO2 was very highly reproducible in both exercise protocols (relative difference 2-test 1/test 1 = -0.32% for the 30 W 3 min protocol; +2.18% for the 10 W.min-1 protocol). The reproducibility of VT was slightly lower regardless of the graphical method used to determine it (relative differences varied from -3.3% to +7.3%). Therefore, peak VO2 appears more suitable than VT for assessment of exercise tolerance in CHF.

Adult↗

PubMed1993

Comparative trial between an ultra-short and long protocol of luteinizing hormone-releasing hormone agonist for ovarian stimulation in in-vitro fertilization.

A total of 312 patients with tubal infertility participated in a prospective randomized study comparing two regimens of ovarian stimulation with a luteinizing hormone-releasing hormone agonist (buserelin) and human menopausal gonadotrophin (HMG). Half of the patients were given an ultra-short treatment protocol when the agonist was administered on days 2, 3 and 4 of the stimulated cycles; the other half were given a long protocol when the agonist was administered from the mid-luteal phase of the cycle preceding the treatment cycle. The mean number of HMG ampoules used per patient was significantly higher in the long protocol. No significant differences were found between the two groups in the incidence of cancelled cycles, failed oocyte recovery, mean number of oocytes recovered per patient, complete failure of fertilization and the fertilization and embryo cleavage rate. More patients undergoing the long protocol had supernumerary embryos cryopreserved and successful deliveries.

Adult↗

PubMed2001

A rapid troponin-I-based protocol for assessing acute chest pain.

In a prospective randomized open trial with 30-day follow-up, we compared a troponin-I-based protocol to 'standard management' for the diagnosis and risk stratification of patients with acute non-ST-elevation chest pain. Patients with acute chest pain (n=400) were randomized to standard diagnostic tests and management, or a protocol based on the admission ECG and the troponin-I result 6 h after onset of chest pain. Low-risk patients were discharged early from CCU; high-risk patients were treated with medical therapy or referred for in-patient angiography as appropriate. We measured length of CCU stay, and followed all patients for major adverse cardiac events (MACE) of death, non-fatal myocardial infarction (MI), or urgent revascularization during the admission and for 30 days post-discharge. The troponin protocol allowed earlier discharge in the low-risk group (10 vs. 30 h, p<0.001) with no excess of adverse events compared to standard management (3% vs. 5%, p=0.32). It identified a group of patients at moderate risk of cardiac events (15% MACE rate during admission and 30-day follow-up), and a high-risk group (75% MACE rate) more accurately than did standard management. The prognostic power of troponin testing in combination with the admission ECG was higher than with either test used alone. The protocol improved the efficiency of low-risk patient management, and improved patient risk stratification. This study adds to the evidence favouring troponin evaluation as part of the management of acute coronary syndromes.

Adult↗

PubMedDate not supplied

Screening protocol for MR imaging of the internal auditory canal.

We have previously shown that 5 mm axial T1-weighted images following Gd-diethylenetriamine pentaacetic acid (DTPA) administration were sufficient as a screening examination of the internal auditory canal (IAC) and cerebellopontine angle cistern in 80% of cases with sensorineural hearing loss. In the remaining 20% of cases 3 mm slices were necessary for confirmation of the diagnosis. To reduce the number of cases requiring the additional examination, we have modified our protocol to include a coronal "scout" T1-weighted sequence followed by 5 mm axial sections angled through the IACs. Routine axial T2-weighted images of the posterior fossa were also obtained. One hundred eleven patients were studied with this protocol. In all but two of these the 5 mm sections unequivocally provided the diagnosis and in those two cases the coronal images confirmed the diagnosis suspected on the axial study. Three millimeter slices were not necessary in any patient. This three sequence, post-Gd-DTPA protocol, which requires only 12 min of scan time, is recommended as a screening protocol for IAC and cerebellopontine angle disease.

Cerebellopontine Angle↗

PubMed1997

Prospective outcome analysis of a protocol for the surgical and rehabilitative management of burns to the hands.

Treatment protocols for the management of burned hands are essential for integrating team efforts and achieving optimal functional results. Standard protocols are especially useful during mass casualty incidents, when the admission of multiple patients with large burns and/or associated injuries may reduce the priority usually accorded the hands. We prospectively evaluated a surgical and rehabilitative treatment protocol for burned hands during a mass casualty incident, after which 43 burn patients with 82 burned hands were admitted to one burn center. Soft-tissue management was individualized to achieve, if possible, wound closure within 14 days, and included the use of topical antimicrobials, cutaneous debridement and/or tangential excision, biologic dressings, and split-thickness autografts. Range of motion therapy was based on daily measurement of active motion of the metacarpophalangealjoints. Static splinting alternating with continuous passive motion every 4 hours was utilized for sedated patients. Continuous passive motion alternating with active ranging and night splinting was utilized for metacarpophalangeal flexion <70 degrees. Active ranging and progressive resistance was utilized for metacarpophalangeal flexion > or =70 degrees. Sixty-four hands required excision and grafting, with 89 percent having at least one autografting procedure completed by postburn day 16. Total active motion of the hands treated averaged 220.6 degrees on discharge and 229.9 degrees at 3 months after injury. Mean hand grip strength was 60.8 pounds at discharge and 66.0 pounds at 3 months after injury. Adherence to a standard hand burn protocol resulted in timely wound coverage and recovery of hand function for a large group of patients treated at a single burn facility after a mass casualty incident.

Accidents, Aviation↗

PubMed1996

Ventilator weaning protocols and techniques: getting the job done.

Various protocols and techniques used to facilitate the weaning process are herein summarized. The protocols were derived from the literature, a survey of critical care nurses, and personal communications with individuals who use innovative methods to expedite the weaning process and reduce costs. The protocols provide a guideline for standardizing the weaning process, but they do not negate the importance of having skilled clinicians who provide continuity in implementing the protocols. The nursing profession has the opportunity to provide leadership in reducing health care costs through implementation of standardized approaches to weaning patients from mechanical ventilatory support.

Clinical Protocols↗

PubMed2002

Evaluation of the Tensioday ambulatory blood pressure monitor according to the protocols of the British Hypertension Society and the Association for the Advancement of Medical Instrumentation.

BACKGROUND: The validation of ambulatory blood pressure monitoring devices is necessary to obtain information on their accuracy. The objective of the present study was to evaluate the accuracy of the Tensioday oscillometric ambulatory blood pressure monitor according to the protocols of the British Hypertension Society and the Association for the Advancement of Medical Instrumentation (AAMI). DESIGN: We followed the phases recommended by the British Hypertension Society protocol: before-use calibration, in-use assessment, after-use calibration, static device validation and report of the evaluation. However, we expanded on the protocol to accommodate features required by the AAMI. METHOD: The accuracy of calibration of three Tensioday devices was tested before and after the in-use phase when each of three devices was performing 10 24 h sessions of ambulatory monitoring. As all three devices passed these phases, the accuracy of blood pressure measurement was tested in one arbitrarily selected device on 85 subjects for systolic and 85 for diastolic blood pressure values. This was done by comparing three sequential same-arm blood pressure readings obtained by the device with three readings obtained by two observers using standard mercury sphygmomanometer. The comparisons were carried out while resting in the seated, supine and standing positions for all subjects. The results were used to grade the performance of the device according to the British Hypertension Society protocol and to calculate the mean +/- standard deviation of the difference between the device and the observers, as required by the AAMI. RESULTS: The Tensioday device achieved an overall grade of A for both the systolic and diastolic measurements, and had a mean difference compared with the observer-measured blood pressure of 1.4 +/- 5.3/1.0 +/- 4.7 mmHg, which satisfies the AAMI criteria for accuracy. The British Hypertension Society grading did not change when patients with low, medium, and high blood pressure were analysed separately. The AAMI accuracy criteria were fulfilled in the standing and lying positions as well. CONCLUSION: On the basis of these results, the Tensioday ambulatory blood pressure monitoring device can be recommended for clinical use for ambulatory monitoring. The accuracy of the device needs, however, further testing in special situations, such as in pregnancy, in elderly patients and during exercise.

Adult↗

PubMed2005

Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols.

OBJECTIVE: Applicability of randomized controlled clinical trial (RCT) results to 'real world' situations is dependent on the comparability of trial participants to general patient populations. A full disclosure of criteria employed for trial enrollment is necessary for clinicians to assess generalizability. We sought to assess both the impact on generalizability and the disclosure rate of enrollment criteria for 32 major HIV RCTs in the AIDS Clinical Trial Group (ACTG) and Community Programs for Clinical Research on AIDS (CPCRA) trial networks. DESIGN AND METHODS: Eligibility criteria were compared in complete protocols to criteria listed in publications from these 32 NIH-funded HIV RCTs. We then applied these criteria to the Women's Interagency HIV Study (WIHS), the largest cohort study of HIV-infected women in the US. RESULTS: When applied to WIHS, eligibility criteria from protocols excluded 0-67.6% (median 42%) of WIHS participants (50.6% excluded from ACTG trials). Eligibility criteria in publications excluded 0-62% (median 19.6%) of WIHS (21.2% excluded from ACTG trials). The number of women in WIHS seemingly ineligible for trial participation per enrollment criteria listed in publications averaged only 60% of those actually excluded based on the protocols. CONCLUSIONS: We found that HIV RCT eligibility criteria excluded a large proportion of a representative cohort of HIV-infected women from trial participation. Furthermore, trial publications are not fully reflective of protocols in terms of disclosing eligibility criteria. Standardization and full disclosure of trial methodology will allow clinicians and researchers to more fully assess the generalizability of findings to their patient populations.

Clinical Protocols↗