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Application of timed artificial insemination protocols to grazing Japanese black cattle with long open period.

To investigate the viability of timed artificial insemination (TAI) protocols in grazing Japanese Black cattle with long open period, ovarian status and progesterone and estradiol-17 beta profiles of the animals during the protocol were monitored. In 1998, prosta-glandin F(2a) (PG) was administered to 36 animals seven days after GnRH injection. Three out of the 36 animals were inseminated after detection of estrus and did not receive further treatment. The second GnRH was injected to the remaining 33 animals 48 hr after the PG injection and TAI was performed 24 hr later. In 1999, PG was injected to 25 animals six days after GnRH, the second GnRH was injected to 22 animals 48 hr after PG, and TAI was performed 16 hr later (The other three animals were inseminated before the time of TAI). The percentage of the animals with at least one functional corpus luteum and one follicle equal to or greater than 10 mm in diameter at PG injection was similar between the groups in 1998 and 1999. Likewise, the hormonal profiles were similar between the two groups. Pregnancy rates (PR) after the TAI protocols and natural mating in 1998 and 1999 were 75.0% and 88.0%, respectively. These figures were comparable to the PR obtained by conventional estrus synchronization protocols using PG (in 1995; 69.4%) or CIDR (in 1996; 59.1%). In conclusion, the TAI protocol can be applicable into grazing Japanese Black cattle with long open period.

Animals↗

Evaluation of a protocol to control utilization of B-type natriuretic peptide testing.

The Veterans Affairs (VA) Boston Healthcare System, Boston, MA, instituted a protocol limiting the number of B-type natriuretic peptide (BNP) assays to 1 per hospitalization or outpatient visit and requiring approval of the cardiology service for more than 1 because of a 3-fold monthly increase in BNP testing. Effectiveness of this protocol was assessed by studying BNP utilization for 6-month periods before and after institution of the protocol. Before: 1,886 assays in 752 patients; mean BNP assays per patient, 2.5; direct reagent cost, $33,948; 1 BNP assay in 57.3% (431) of patients; 321 patients with multiple and 204 patients with serial BNP requests. After: 782 assays (-58.5%) in 593 patients (-21.1%); mean BNP assays per patient, 1.3 (-48.0%); direct reagent cost, $14,076 (-58.5%); 1 BNP assay in 81.1% (481) of patients; 112 patients with multiple and 24 patients with serial BNP requests (-88.2%). The emergency department was the source of BNP assays in 15.4% of requests before compared with 58.1% after introduction of the protocol. The protocol with slight modifications has been adopted by other VA medical centers in New England and may serve as a model for other medical facilities seeking to control BNP utilization.

Cost-Benefit Analysis↗

Assessment of an age-adjusted warfarin initiation protocol.

OBJECTIVE: To examine the time taken to reach a stable international normalized ratio (INR), as well as the incidence of overanticoagulation of an age-adjusted warfarin initiation protocol. METHODS: Inpatients and outpatients commencing warfarin therapy at 2 teaching hospitals were dosed according to the age-adjusted protocol. Data were collected prospectively. MAIN OUTCOME MEASURES: Time to reach a stable INR of 2-3 and the number of patients experiencing an INR > or =4 during the first week of warfarin therapy. RESULTS: Seventy-three patients were assessed; at the completion of the 4-day titration protocol, 63% had achieved a stable INR. After an additional 2 days of empiric dosage adjustment by the attending physician, 86% of the subjects demonstrated a stable INR. Five patients (7%) experienced an INR > or =4. These patients had a nonsignificant trend toward a lower plasma albumin level compared with other patients (p = 0.057, Student's t-test). The INR-driven dose adjustments on days 3 and 4 of this protocol coped with other variables that have been shown to affect maintenance warfarin dosing. These included weight, gender, pharmacologic factors affecting clearance, and the presence of certain predesignated risk factors. CONCLUSIONS: The age-adjusted dosing protocol rapidly achieved a stable INR with minimal overanticoagulation. Patients with low serum albumin levels (<3.0 g/dL) may be sensitive to the effects of warfarin during the loading phase.

Adult↗

Difficult-to-control asthma. Contributing factors and outcome of a systematic management protocol.

To our knowledge, there are no published results of protocols for managing difficult to control asthma (DTCA) or of the spectrum and frequencies of reasons why asthma can be difficult to control (DTC). To assess the usefulness of a systematic management protocol and determine the reason(s) why asthmatics are DTC, we developed a protocol that systematically considered multiple factors that may make asthma worse and prospectively evaluated the outcomes of therapeutic interventions for these factors and of inhaled corticosteroids (ICS) and azathioprine. We studied 42 consecutive and unselected DTCAs (19 men and 23 women) whose age was 48 +/- 15.9 years. They had a diagnosis of asthma for 15.1 +/- 15.8 years, were DTC for 4.8 +/- 7.8 years, and were followed up by us in the study for a total of 3.5 +/- 1.9 years. Initially, the dose of prednisone was 30.2 +/- 22 mg/d. Following utilization of the protocol, 74 percent were no longer DTC. It took 1.8 +/- 1.7 years for them to no longer be DTC; they remained so for 1.8 +/- 1.5 years. In these patients, 2.7 +/- 1.2 factors appeared to be responsible for the DTC state; 80 percent had > or = 2. Improvement was more likely if gastroesophageal reflux (GER) was a factor (p = 0.014); it correlated with the addition of ICS (p = 0.04) and treatment for GER (p = 0.02). Failure to reverse DTCA correlated with the suspicion (p = 0.004) and admission of nonadherence (p = 0.04). In 14 patients given azathioprine, prednisone dose decreased from 45 +/- 25.3 to 13.3 +/- 21.6 mg/d (p = 0.003); 6 of 14 achieved no longer DTC status; and substantial morbidity occurred. The reason(s) for DTCA could be determined in most instances by utilizing a systematic protocol; multiple factors were responsible in the majority of cases; treatment for GER and ICS were the two most helpful interventions; nonadherence was the most likely reason suspected for maintaining DTCA; and azathioprine acted as a corticosteroid-sparing agent that should not be prescribed routinely.

Adolescent↗

A short protocol for methacholine provocation testing adapted to the Rosenthal-Chai dosimeter technique.

BACKGROUND: The purpose of this study was to develop a rapid and safe methacholine provocation protocol equivalent to the standard dosimeter technique. METHODS: The rapid protocol comprised a short and a long subprotocol. The challenge was started with one of these subprotocols according to the subject's answers to a questionnaire and baseline lung function. If FEV1 dropped by 10% during the short subprotocol, the test was continued with the long subprotocol. The concentrations of methacholine and numbers of inhalations were chosen to match the concentrations of the standard method as closely as possible. To verify the protocol, we compared both methods in 38 subjects with asthma and 10 control subjects. RESULTS: The provocative concentrations of methacholine (PC20FEV1) obtained with the standard method and the rapid method were within one doubling concentration in 38 of 40 subjects. None of the subjects who were normoreactive according to the standard method (PC20FEV1 > 8 mg/mL) responded in the rapid protocol. The standard method required, on average (+/-SD), 34+/-11 min; the rapid method required 15+/-3 min. CONCLUSIONS: The rapid provocation protocol is equivalent to the standard method, without loss in precision and safety, but with considerable saving in time. Therefore, it appears to be particularly suited for studies that require comparability with provocative concentrations obtained with the Rosenthal-Chai dosimeter method.

Adult↗

Gold chloride technique to study articular innervation. A protocol validated through computer-assisted colorimetry.

We studied variations in gold chloride techniques to elicit neural elements within articular samples, after "in toto" staining. These techniques attempt the differentiation of neural and vascular structures. Major changes in differential staining were observed when the gold chloride concentration was empirically modified. After the rest of the technique was standardized, we selected three gold chloride solutions to perform quantitative color experiments: 1%, 0.75%, and 0.5%. Significant sections of the same thickness were acquired with a digital camera to perform computer-assisted colorimetry. Color was measured through RGB (red-green-blue) channels in vessels, nerves, and background connective tissue as an internal control. By means of multivariate regression analysis, we compared differences in color measurements after 1%, 0.75% and 0.5% gold chloride preparation. Statistically significant coefficients confirmed that red color signals in vessels after the 0.75% and the 0.5% solution were both less intense than after the 1% preparation. Green and blue signals in vessels were also significantly less intense after the 0.5% protocol than after using the 1% solution. Red color signals in nerves between the 1% and the 0.75% preparation protocols were more intense and not significantly different, while the 0.5% preparation produced significantly less intense red signals in nerves. Non-significant differences were observed in green or blue signals from nerves after any protocol. We concluded that the 0.75% gold chloride solution protocol produced more intense red signals in nerves and less intense red signals in vessels. This was the most discriminant protocol in our series, based on color signals.

Adolescent↗

Medium-term protocols for in vivo evaluation of chemical modifiers of carcinogenesis.

Cancer development is a long-term multistep process which allows interventional measure before the clinical disease emerges. The detection of natural substances which can block the process of carcinogenesis is as important as the identification of anti-tumoral drugs since they might be used in chemoprevention of cancer in high-risk groups. In vivo rodent models of chemical carcinogenesis have been used to study plant-derived inhibitors of carcinogenesis such as indoles, coumarins, isothiocyanates, flavones, phenols and allyl-sulfides. Since the standard in vivo rodent bioassay is prolonged and expensive, shorter reliable protocols are needed. Two in vivo medium-term protocols for evaluation of modifiers of carcinogenesis are presented, one related to liver and the other to bladder cancer. Both protocols use rats, last 8 and 36 weeks and are based on the two-step concept of carcinogenesis: initiation and promotion. The protocols use respectively the development of altered foci of hepatocytes expressing immunohistochemically the placental form of glutathione S-transferase and the appearance of pre-neoplastic urothelium and papillomas as the "end-points". The use of these protocols for detection of plant-derived inhibitors of carcinogenesis appear warranted.

Animals↗

Partial recording protocols for periodontal disease assessment in epidemiological surveys.

The objective of the present study was to compare the reliability of four partial-mouth protocols for assessing shallow, moderate, and deep sites for periodontal pocket depth and clinical attachment levels. Periodontal pocket depth and clinical attachment level measurements were recorded for 156 subjects (age > or = 30). The four models of partial-mouth protocols compared were: Model I: all sites per tooth in the random half-mouth protocol randomly selecting one maxillary and mandibular quadrant, Model II: buccal sites in a full-mouth protocol, Model III: buccal sites in the random half-mouth protocol randomly selecting one maxillary and mandibular quadrant, Model IV: all sites per tooth using Community Periodontal Index teeth. In comparison with full mouth examination, Model I did not show significant differences for periodontal pocket depth and clinical attachment level parameters. Models II and III were different for some periodontal pocket depth means, and Model IV significantly overestimated all clinical parameters related to periodontal disease. Model I appears to be adequate to substitute for the full-mouth examination to assess the prevalence and severity of chronic periodontal disease in adults.

Adult↗

The cleft audit protocol for speech-augmented: A validated and reliable measure for auditing cleft speech.

OBJECTIVES: To develop an assessment tool for use in intercenter audit studies of cleft speech and to test its acceptability, validity, and reliability. The tool is to be used systematically to record and report speech outcomes, providing an indication of treatment needs and continuing burden of care. SETTING: Regional Cleft Center, U.K. METHODS: The Cleft Audit Protocol for Speech-Augmented (CAPS-A) was developed by three cleft speech experts who identified the key features required from existing assessment measures. Criterion validity was assessed by comparing the Cleft Audit Protocol for Speech-Augmented outcomes reported for 20 cases with clinical assessment results and other investigations. Intra- and interrater reliability were tested following the training of specialist speech and language therapists who used the Cleft Audit Protocol for Speech-Augmented on two occasions to assess 10 cases. The raters evaluated acceptability and ease of using a questionnaire. RESULTS: The mean percentage agreement for criterion validity in each section was 87% (range 70% to 100%). Both intra- and interexaminer reliability were rated as good/very good (Kappa 0.61 to 1.00) for seven sections and moderate (Kappa 0.41 to 0.60) for three sections. Raters reported that the Cleft Audit Protocol for Speech-Augmented was acceptable and easy to use with appropriate training. CONCLUSION: An acceptable, valid, and reliable cleft speech audit tool has been developed based on a small sample. The Cleft Audit Protocol for Speech-Augmented is recommended for use in intercenter audit studies in the U.K. and Ireland and could be used in other English-speaking countries. In addition, it has wider applicability for use in reporting speech outcomes of surgical procedures.

Adult↗

SPIKES-A six-step protocol for delivering bad news: application to the patient with cancer.

We describe a protocol for disclosing unfavorable information-"breaking bad news"-to cancer patients about their illness. Straightforward and practical, the protocol meets the requirements defined by published research on this topic. The protocol (SPIKES) consists of six steps. The goal is to enable the clinician to fulfill the four most important objectives of the interview disclosing bad news: gathering information from the patient, transmitting the medical information, providing support to the patient, and eliciting the patient's collaboration in developing a strategy or treatment plan for the future. Oncologists, oncology trainees, and medical students who have been taught the protocol have reported increased confidence in their ability to disclose unfavorable medical information to patients. Directions for continuing assessment of the protocol are suggested.

Communication↗

Experimental control of nodality via equal presentations of conditional discriminations in different equivalence protocols under speed and no-speed conditions.

A within-participant comparison of simple-to-complex, complex-to-simple, and simultaneous protocols was conducted establishing different sets of three 7-member equivalence classes for 4 undergraduate students. The protocols were implemented under either accuracy-only or accuracy-plus-speed conditions while keeping number of presentations of training and testing trials equal. The results partially support previous reports of differential effects on acquisition, with participants completing more blocks in training under the simultaneous than the complex-to-simple and the simple-to-complex protocols. Across the protocols, however, the number of trials completed to criterion did not vary systematically. More important, response speed and accuracy did not decrease as a function of nodal number, with or without the speed contingency, or under any protocol. The latter results challenge the generality of previous reports of the nodality effect and the notion of "relatedness" of equivalence-class members, and support a reinforcement-contingency, instead of a structural, perspective on equivalence-class formation.

Adult↗

A comparison of discharge and two-week duplex ultrasound screening protocols for deep venous thrombosis detection following primary total joint arthroplasty.

BACKGROUND: Thromboembolic disease in the form of deep venous thrombosis and pulmonary embolism is a risk following hip and knee joint replacement. Prophylactic and screening protocols have been employed to prevent thromboembolic disease following lower extremity joint reconstruction. The purpose of the present study was to evaluate two noninvasive venous screening protocols, specifically, compression ultrasonography performed either at the time of hospital discharge or two weeks after the operation. METHODS: From 1994 through 2001, 2364 patients undergoing primary unilateral total hip or total knee arthroplasty were managed with an anticoagulation chemoprophylaxis protocol (adjusted-dose warfarin) until the time of noninvasive venous screening with use of one of two protocols. Nine hundred thirty-one patients (406 hips and 525 knees) underwent compression ultrasonography prior to hospital discharge, and the other 1433 patients (614 hips and 819 knees) underwent ultrasonographic screening two weeks after the operation. RESULTS: Twenty-three proximal deep venous thromboses (prevalence, 2.5%) were identified in the group that underwent ultrasound screening at the time of hospital discharge, and thirty-one proximal thromboses (prevalence, 2.2%) were identified in the group that underwent ultrasound screening two weeks after the operation. There was no significant difference between the two protocols with regard to the detection of deep venous thrombosis. CONCLUSIONS: There was no significant difference between the group that received two weeks of warfarin chemoprophylactic prophylaxis and the group that was screened at the time of hospital discharge with regard to the detection of deep venous thrombosis with use of compression ultrasound. On the basis of these findings, we no longer screen asymptomatic patients for deep venous thrombosis following hip and knee replacement, and all patients receive warfarin anticoagulation for two weeks.

Anticoagulants↗

Test protocols for evaluation of spinal implants.

Prior to implantation, medical devices are subjected to rigorous testing to ensure safety and efficacy. A full battery of testing protocols for implantable spinal devices may include many steps. Testing for biocompatibility is a necessary first step. On selection of the material, evaluation protocols should address both the biomechanical and clinical performance of the device. Before and during mechanical testing, finite element modeling can be used to optimize the design, predict performance, and, to some extent, predict durability and efficacy of the device. Following bench-type evaluations, the biomechanical characteristics of the device (e.g., motion, load-sharing, and intradiscal pressure) can be evaluated with use of fresh human cadaveric spines. The information gained from cadaveric testing may be supplemented by the finite element model-based analyses. Upon the successful completion of these tests, studies that make use of an animal model are performed to assess the structure, function, histology, and biomechanics of the device in situ and as a final step before clinical investigations are initiated. The protocols that are presently being used for the testing of spinal devices reflect the basic and applied research experience of the last three decades in the field of orthopaedic biomechanics in general and the spine in particular. The innovation within the spinal implant industry (e.g., fusion devices in the past versus motion-preservation devices at present) suggests that test protocols represent a dynamic process that must keep pace with changing expectations. Apart from randomized clinical trials, no single test can fully evaluate all of the characteristics of a device. Due to the inherent limitations of each test, data must be viewed in a proper context. Finally, a case is made for the medical community to converge toward standardized test protocols that will enable us to compare the vast number of currently available devices, whether on the market or still under development, in a systematic, laboratory-independent manner.

Animals↗

Simple protocols to determine dust potentials from cattle feedlot soil and surface samples.

Cattle feedlot dust is an annoyance and may be a route for nutrient transport, odor emission, and pathogen dispersion, but important environmental factors that contribute to dust emissions are poorly characterized. A general protocol was devised to test feedlot samples for their ability to produce dust under a variety of environmental conditions. A blender was modified to produce dust from a variety of dried feedlot surface and soil samples and collect airborne particles on glass fiber filters by vacuum collection. A general blending protocol optimized for sample volume (150-175 cm3), blending time (5 min of pre-blending), and dust collection time (15 s) provided consistent dust measurements for all samples tested. The procedure performed well on samples that varied in organic matter content, but was restricted to samples containing less than 200 to 700 g H2O kg(-1) dry matter (DM). When applied to field samples, the technique demonstrated considerable spatial variability between feedlot pen sites. Mechanistically, dust potential was related to moisture and organic matter content. An alternative protocol also demonstrated differences within pen sites in maximum dust potential and dust airborne residence time. The two protocols were not intended, nor are they suitable, for predicting actual particulate matter emissions from agricultural sources. Rather, the protocols rapidly and inexpensively compared the potential for dust emission from samples of differing composition under a variety of environmental conditions.

Agriculture↗

Informed consent for percutaneous lung biopsy: comparison of two consent protocols based on patient recall after the procedure.

OBJECTIVE: Informed consent is now required for the majority of radiologic procedures, but few studies have evaluated the efficacy of informed consent protocols. We compared our standard consent protocol of obtaining consent prior to percutaneous lung biopsy with a modified protocol by using patients' recall of procedure risks after the biopsy as an indicator of patients' comprehension. SUBJECTS AND METHODS: The study sample consisted of 50 patients who underwent percutaneous lung biopsy between December 1992 and June 1994. Twenty-seven patients received our standard informed consent procedure in which four important procedure risks were described briefly using our standard method. Twenty-three patients underwent a consent procedure that had the following modification. After the four procedure risks were described, the patient was tested verbally until all risks could be recited to the physician. This change required 5 additional min at most. In both protocols, efficacy of the procedure was evaluated by testing patient recall 4 hr after consent was obtained. We also assessed any effect that might have been introduced by differences between the groups, age, sex, time between consent and recall, and complications during the procedure. RESULTS: Patients' recall was significantly better in the modified consent group than in the standard group (p = .005). This result could not be attributed to differences in age, sex, or time between consent and recall. There was a trend for improved recall in patients with complications. This trend did not appear to influence our principal finding. CONCLUSION: The standard consent procedure for lung biopsy appears inadequate when patients' recall of procedure risks later is used as a measure of the patients' comprehension. Based on this study, the informed consent process may be improved substantially by teaching patients to recite the procedure risks to the physician as part of the informed consent protocol.

Adult↗

Individually adapted examination protocols for reduction of radiation exposure for 16-MDCT chest examinations.

OBJECTIVE: The purpose of our study was to develop a simple protocol for reduction of radiation exposure without loss of diagnostic information in chest 16-MDCT. MATERIALS AND METHODS: Two hundred and four patients underwent MDCT of the thorax (Somatom Sensation 16, Siemens). Group 1 was scanned using a standard protocol with 100 mAs(effective) (mAs(eff)). Group 2 was scanned using a dose modulation template (CareDose). Group 3 was scanned with mAs(eff) = body weight (kg). Group 4 was scanned with a combination of weight-adapted mAs(eff) and dose modulation. All other parameters were kept constant. Signal-to-noise ratio was assessed as an objective measurement for image quality, and subjective image quality was rated by three experienced radiologists on a 4-point scale. Effective dose was calculated using dedicated software. RESULTS: The mean noise measurement values were 8.31 H for the 100 mAs(eff) protocol for the regression between weight and signal-to-noise (p < 0.0001), 9.08 H for group 2 (p < 0.0001), 9.0 H for group 3 (p = 0.5051), and 9.98 H for group 4 (p = 0.0152). The median image quality was 1 (1 = highest quality) in all subgroups. The mean effective dose was 6.83 mSv, 5.92 mSv, 4.73 mSv, and 3.97 mSv, respectively. The least correlation between weight and image noise was achieved for the individually weight-adapted protocol and in the weight-adapted with CareDose combination. CONCLUSION: By tube current time product adaptation (kg = mAs(eff)) combined with an online tube current modulation template, a well-balanced examination without significant loss of information was achieved for this specific scanner. Thus, individually adapted protocols for chest 16-MDCT can be recommended.

Algorithms↗

Method of insulin administration has no effect on insulin sensitivity estimates from the insulin-modified minimal model protocol.

The effect of the method of insulin administration on insulin sensitivity estimates from the insulin modified minimal model (MINMOD) protocol was evaluated using the tolbutamide-boosted protocol as a reference. The study included 21 nondiabetic men ages 40 +/- 2 years (mean +/- SE) with a BMI of 26.6 +/- 1.1 kg/m2. Each subject underwent four frequently sampled intravenous glucose tolerance tests (FSIGTT), one with tolbutamide and three with the same insulin dosage (0.03 U/kg) given as a bolus or infusion over 5 or 10 min. The insulin sensitivity index (SI) of each subject was calculated from each FSIGTT with MINMOD. Insulin sensitivity indexes from the four FSIGTTs were highly correlated (r > 0.85, P < 0.001). SI(insulin) from the bolus and the 5- and 10-min infusion protocols were similar, but were 21 +/- 5, 29 +/- 5, and 23 +/- 4% lower than SI(tolbutamide), respectively. SG(tolbutamide) and SG(insulin) were not different among the four protocols and were significantly correlated (r > 0.55, P < 0.01). Thus the tolbutamide and insulin protocols must not be used interchangeably in any single cross-sectional or longitudinal study. When the same insulin dosage is used, the method of its administration has no bearing on insulin sensitivity estimates from the insulin-modified FSIGTT. The same method of insulin administration should be used, however, in any single study for purpose of standardization.

Adult↗

Diabetes in urban African-Americans. IX. Provider adherence to management protocols.

OBJECTIVE: Staged diabetes management should permit glycemic goals to be attained in a timely manner, but the success of such an approach requires conformity by health care providers. To test performance, we analyzed the adherence of practitioners to a protocol for staged management of NIDDM patients. RESEARCH DESIGN AND METHODS: Records of patients treated at the Grady Memorial Hospital Diabetes Clinic were reviewed retrospectively over a 3-year period. For each patient, intensification of therapy was indicated if fasting plasma glucose was > 7.8 mmol/l and a prior HbA1c was > 7.0%. Protocols dictated a progression from dietary therapy alone to increasing dosages of sulfonylureas to increasing dosages of insulin. Patients were seen at bimonthly intervals. RESULTS: During the 3-year period, 1,051 patient visits met protocol criteria for intensification. Adherence to the protocol improved significantly in the 3rd year compared with the first 2 years (30, 31, and 47% adherence in the 1st, 2nd, and 3rd years, respectively). Patients treated with diet alone were significantly less likely to have their therapy intensified than patients on sulfonylureas or insulin (intensification rates 25, 41, and 47%, respectively). In the management of patients treated with diet alone, practitioners were reluctant to intensify therapy at early visits, but were more likely to do so later, 19% of patients beyond goal range at the 2-month visit were started on pharmacological therapy vs. 28% at the 4-month visit, and 39% at the 6-month visit (P < 0.01). In contrast, there was no significant difference in the frequency of therapy intensification between early and late visits for patients on sulfonylureas or insulin. Practitioners appeared to base the decision to intensify on the fasting plasma glucose level more than on the most recent HbA1c. Age did not appear to be a significant factor in the decision to intensify. CONCLUSIONS: Although staged management protocols constitute critical tools to achieve glycemic goals, the adherence of health care providers may be suboptimal. Special efforts may be needed to assure compliance.

Black or African American↗