Development and Validation of a Sulfa Antibiotic Allergy Clinical Decision Rule.
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ABSTRACT:
SUBMITTER: Waldron JL
PROVIDER: S-EPMC10242418 | biostudies-literature | 2023 Jun
REPOSITORIES: biostudies-literature
Publications
Development and Validation of a Sulfa Antibiotic Allergy Clinical Decision Rule.
Waldron Jamie L JL Rose Morgan M Vogrin Sara S Krantz Matthew S MS Bolotte Ryan R Phillips Elizabeth J EJ Trubiano Jason A JA
JAMA network open 20230601 6
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Project description:ImportancePenicillin allergy is a significant public health issue for patients, antimicrobial stewardship programs, and health services. Validated clinical decision rules are urgently needed to identify low-risk penicillin allergies that potentially do not require penicillin skin testing by a specialist.ObjectiveTo develop and validate a penicillin allergy clinical decision rule that enables point-of-care risk assessment of patient-reported penicillin allergies.Design, setting, and participantsIn this diagnostic study, a multicenter prospective antibiotic allergy-tested cohort of 622 patients from 2 tertiary care sites in Melbourne, Australia (Austin Health and Peter MacCallum Cancer Centre) was used for derivation and internal validation of a penicillin allergy decision rule. Backward stepwise logistic regression was used to derive the model, including clinical variables predictive of a positive penicillin allergy test result. Internal validation of the final model used bootstrapped samples and the model scoring derived from the coefficients. External validation was performed in retrospective penicillin allergy-tested cohorts consisting of 945 patients from Sydney and Perth, Australia, and Nashville, Tennessee. Patients who reported a penicillin allergy underwent penicillin allergy testing using skin prick, intradermal, or patch testing and/or oral challenge (direct or after skin testing). Data were collected from June 26, 2008, to June 3, 2019, and analyzed from January 9 to 12, 2019.Main outcomes and measuresThe primary outcome for the model was any positive result of penicillin allergy testing performed during outpatient or inpatient assessment.ResultsFrom an internal derivation and validation cohort of 622 patients (367 female [59.0%]; median age, 60 [interquartile range{IQR}, 48-71] years) and an external validation cohort of 945 patients (662 female [70.1%]; median age, 55 [IQR, 38-68] years), the 4 features associated with a positive penicillin allergy test result on multivariable analysis were summarized in the mnemonic PEN-FAST: penicillin allergy, five or fewer years ago, anaphylaxis/angioedema, severe cutaneous adverse reaction (SCAR), and treatment required for allergy episode. The major criteria included an allergy event occurring 5 or fewer years ago (2 points) and anaphylaxis/angioedema or SCAR (2 points); the minor criterion (1 point), treatment required for an allergy episode. Internal validation showed minimal mean optimism of 0.003 with internally validated area under the curve of 0.805. A cutoff of less than 3 points for PEN-FAST was chosen to classify a low risk of penicillin allergy, for which only 17 of 460 patients (3.7%) had positive results of allergy testing, with a negative predictive value of 96.3% (95% CI, 94.1%-97.8%). External validation resulted in similar findings.Conclusions and relevanceIn this study, PEN-FAST was found to be a simple rule that accurately identified low-risk penicillin allergies that do not require formal allergy testing. The results suggest that a PEN-FAST score of less than 3, associated with a high negative predictive value, could be used by clinicians and antimicrobial stewardship programs to identify low-risk penicillin allergies at the point of care.
| S-EPMC7076536 | biostudies-literature
Project description: Not available
| S-EPMC6960372 | biostudies-literature
Project description:The concern for diverticulitis often leads to the use of computed tomography (CT) scans for diagnosis. We aim to develop an ultrasound-based clinical decision rule (CDR) to confidently rule-out the disease without requiring a CT scan. We analyzed data from a prospective study of adult emergency department (ED) patients with suspected diverticulitis who underwent both bedside ultrasound (US) and CT. Patient history, physical examination, laboratory findings, and US results were used to create a CDR via a recursive partitioning model designed to prioritize sensitivity, with a loss matrix heavily penalizing false negatives. We calculated the test characteristics for this CDR (TICS-Rule) and assessed the potential reduction in CT scans and ED length of stay. Data from 149 patients (84 female; mean age 58 ± 16) were used to develop the TICS-Rule. The final model integrates US diagnosis of simple and complicated diverticulitis, along with variables of heart rate, age, history of diverticulosis, vomiting, and leukocytosis. Negative US results and a heart rate below 100 effectively excluded diverticulitis. The sensitivity increased from 54.5% (32.2-75.6) in the US alone to 100% (84.6-100%) for complicated diverticulitis in the model. The TICS-Rule missed no cases of complicated diverticulitis but one case of simple diverticulitis. The median time from ED greeting to US interpretation was 103 min (IQR 62-169), compared to 285 min (IQR 229-372) for CT. The TICS-Rule uses a combination of negative US and heart rate less thanQ1 100 to exclude diverticulitis without the need for a CT scan. Integration of the TICS-Rule offers a promising enhancement to clinical decision-making while reducing both CT use and ED length of stay.
| S-EPMC11531591 | biostudies-literature
Project description:ObjectivePatients with suspected acute aortic syndromes (AAS) often undergo computed tomography (CT) with negative results. We sought clinical and diagnostic criteria to identify low-risk patients, an initial step in developing a clinical decision rule.MethodsWe retrospectively identified all adults presenting to our emergency department (ED) from January 1, 2006, to August 1, 2010, who underwent CT angiography for suspected AAS without prior trauma or AAS. A total of 1465 patients met inclusion criteria; a retrospective case-controlled review (ratio 1:4) was conducted. Cases were diagnosed with aortic dissection, intramural hematoma, penetrating atherosclerotic ulcer, or ruptured aneurysm.ResultsOf the patients who underwent CT, 2.7% (40/1465) had an AAS; 2 additional cases were diagnosed after admission (ED miss rate, 5% [2/42]). Patients with AAS were significantly older than controls (66 vs 59 years; P = .008). Risk factors included abnormal chest radiograph (sensitivity, 79% [26/33]; specificity, 82% [113/137]) and acute chest pain (sensitivity, 83% [29/35]; specificity, 71% [111/157]). None of the 19 patients with resolved pain upon ED presentation had AAS. These data support a 2-step rule: first screen for ongoing pain; if present, screen for acute chest pain or an abnormal chest radiograph. This approach achieves a 54% (84/155) reduction in CT usage with a sensitivity for AAS of 96% (95% confidence interval, 89%-100%), negative predictive value of 99.8% (99.4%-100%), and a false-negative rate of 1.7% (1/84).ConclusionsOur results demonstrate a need to safely identify patients at low risk for AAS who can forgo CT. We developed a preliminary 2-step clinical decision rule, which requires validation.
| S-EPMC4275798 | biostudies-literature
Project description:BACKGROUND: Numerous short-statured children are evaluated for growth hormone (GH) deficiency (GHD). In most patients, GH provocative tests are normal and are thus in retrospect unnecessary. METHODS: A retrospective cohort study was conducted to identify predictors of growth hormone (GH) deficiency (GHD) in children seen for short stature, and to construct a very sensitive and fairly specific predictive tool to avoid unnecessary GH provocative tests. GHD was defined by the presence of 2 GH concentration peaks < 10 ng/ml. Certain GHD was defined as GHD and viewing pituitary stalk interruption syndrome on magnetic resonance imaging. Independent predictors were identified with uni- and multi-variate analyses and then combined in a decision rule that was validated in another population. RESULTS: The initial study included 167 patients, 36 (22%) of whom had GHD, including 5 (3%) with certain GHD. Independent predictors of GHD were: growth rate < -1 DS (adjusted odds ratio: 3.2; 95% confidence interval [1.3-7.9]), IGF-I concentration < -2 DS (2.8 [1.1-7.3]) and BMI z-score > or = 0 (2.8 [1.2-6.5]). A clinical decision rule suggesting that patients be tested only if they had a growth rate < -1 DS and a IGF-I concentration < -2 DS achieved 100% sensitivity [48-100] for certain GHD and 63% [47-79] for GHD, and a specificity of 68% [60-76]. Applying this rule to the validation population (n = 40, including 13 patients with certain GHD), the sensitivity for certain GHD was 92% [76-100] and the specificity 70% [53-88]. CONCLUSION: We have derived and performed an internal validation of a highly sensitive decision rule that could safely help to avoid more than 2/3 of the unnecessary GH tests. External validation of this rule is needed before any application.
| S-EPMC2492843 | biostudies-other
Project description:ImportanceFewer than 5% of patients labeled with a penicillin allergy are truly allergic. The standard of care to remove the penicillin allergy label in adults is specialized testing involving prick and intradermal skin testing followed by an oral challenge with penicillin. Skin testing is resource intensive, limits practice to specialist-trained physicians, and restricts the global population who could undergo penicillin allergy delabeling.ObjectiveTo determine whether a direct oral penicillin challenge is noninferior to the standard of care of penicillin skin testing followed by an oral challenge in patients with a low-risk penicillin allergy.Design, setting, and participantsThis parallel, 2-arm, noninferiority, open-label, multicenter, international randomized clinical trial occurred in 6 specialized centers, 3 in North America (US and Canada) and 3 in Australia, from June 18, 2021, to December 2, 2022. Eligible adults had a PEN-FAST score lower than 3. PEN-FAST is a prospectively derived and internationally validated clinical decision rule that enables point-of-care risk assessment for adults reporting penicillin allergies.InterventionsPatients were randomly assigned to either direct oral challenge with penicillin (intervention arm) or a standard-of-care arm of penicillin skin testing followed by oral challenge with penicillin (control arm).Main outcome and measureThe primary outcome was a physician-verified positive immune-mediated oral penicillin challenge within 1 hour postintervention in the intention-to-treat population. Noninferiority was achieved if a 1-sided 95% CI of the risk difference (RD) did not exceed 5 percentage points (pp).ResultsA total of 382 adults were randomized, with 377 patients (median [IQR] age, 51 [35-65] years; 247 [65.5%] female) included in the analysis: 187 in the intervention group and 190 in the control group. Most patients had a PEN-FAST score of 0 or 1. The primary outcome occurred in 1 patient (0.5%) in the intervention group and 1 patient (0.5%) in the control group, with an RD of 0.0084 pp (90% CI, -1.22 to 1.24 pp). The 1-sided 95% CI was below the noninferiority margin of 5 pp. In the 5 days following the oral penicillin challenge, 9 immune-mediated adverse events were recorded in the intervention group and 10 in the control group (RD, -0.45 pp; 95% CI, -4.87 to 3.96 pp). No serious adverse events occurred.Conclusions and relevanceIn this randomized clinical trial, direct oral penicillin challenge in patients with a low-risk penicillin allergy was noninferior compared with standard-of-care skin testing followed by oral challenge. In patients with a low-risk history, direct oral penicillin challenge is a safe procedure to facilitate the removal of a penicillin allergy label.Trial registrationClinicalTrials.gov Identifier: NCT04454229.
| S-EPMC10352926 | biostudies-literature
Project description:ImportanceBruising caused by physical abuse is the most common antecedent injury to be overlooked or misdiagnosed as nonabusive before an abuse-related fatality or near-fatality in a young child. Bruising occurs from both nonabuse and abuse, but differences identified by a clinical decision rule may allow improved and earlier recognition of the abused child.ObjectiveTo refine and validate a previously derived bruising clinical decision rule (BCDR), the TEN-4 (bruising to torso, ear, or neck or any bruising on an infant <4.99 months of age), for identifying children at risk of having been physically abused.Design, setting, and participantsThis prospective cross-sectional study was conducted from December 1, 2011, to March 31, 2016, at emergency departments of 5 urban children's hospitals. Children younger than 4 years with bruising were identified through deliberate examination. Statistical analysis was completed in June 2020.ExposuresBruising characteristics in 34 discrete body regions, patterned bruising, cumulative bruise counts, and patient's age. The BCDR was refined and validated based on these variables using binary recursive partitioning analysis.Main outcomes and measuresInjury from abusive vs nonabusive trauma was determined by the consensus judgment of a multidisciplinary expert panel.ResultsA total of 21 123 children were consecutively screened for bruising, and 2161 patients (mean [SD] age, 2.1 [1.1] years; 1296 [60%] male; 1785 [83%] White; 1484 [69%] non-Hispanic/Latino) were enrolled. The expert panel achieved consensus on 2123 patients (98%), classifying 410 (19%) as abuse and 1713 (79%) as nonabuse. A classification tree was fit to refine the rule and validated via bootstrap resampling. The resulting BCDR was 95.6% (95% CI, 93.0%-97.3%) sensitive and 87.1% (95% CI, 85.4%-88.6%) specific for distinguishing abuse from nonabusive trauma based on body region bruised (torso, ear, neck, frenulum, angle of jaw, cheeks [fleshy], eyelids, and subconjunctivae), bruising anywhere on an infant 4.99 months and younger, or patterned bruising (TEN-4-FACESp).Conclusions and relevanceIn this study, an affirmative finding for any of the 3 BCDR TEN-4-FACESp components in children younger than 4 years indicated a potential risk for abuse; these results warrant further evaluation. Clinical application of this tool has the potential to improve recognition of abuse in young children with bruising.
| S-EPMC8047759 | biostudies-literature
Project description: Not available
| S-EPMC6395557 | biostudies-literature
Project description:ObjectivesNational and international guidelines recommend prompt referral of patients presenting with inflammatory arthritis (IA), but general practitioners (GPs) feel uncertain in their proficiency to detect synovitis through joint examination, the method of choice to identify IA. Our objective was to develop and validate a rule composed of clinical characteristics to assist GPs and other physicians in identifying IA when in doubt.DesignSplit-sample derivation and validation study.SettingThe Leiden Early Arthritis Recognition Clinic (EARC), a screening clinic for patients in whom GPs suspected but were unsure of the presence of IA.Participants1288 consecutive patients visiting the EARC.Primary and secondary outcome measuresAssociations of clinical characteristics with presence of IA were determined using logistic regression in 644 patients, while validating the results in the other 644 patients (split-sample validation). To facilitate application in clinical practice, a simplified rule (with scores ranging from 0 to 7.5) was derived and validated.ResultsIA was identified by a rheumatologist in 41% of patients. In univariable analysis, male gender, age ≥60 years, symptom duration <6 weeks, morning stiffness >60 min, a low number of painful joints (1-3 joints), presence of patient-reported joint swelling and difficulty with making a fist were associated with IA in the derivation data set. Using multivariable analysis, a simplified rule consisting of these seven items was derived and validated, yielding an area under the receiver operator characteristic curve (AUC) of 0.74 (95% CI 0.70 to 0.78) in the derivation data set. Validation yielded an AUC of 0.71 (95% CI 0.67 to 0.75). Finally, the model was repeated to study predicted probabilities with a lower prevalence of inflammatory arthritis to simulate performance in primary care settings.ConclusionsOur rule, composed of clinical parameters, had reasonable discriminative ability for IA and could assist physicians in decision-making in patients with suspected IA, increasing appropriateness of healthcare utilisation.
| S-EPMC6278800 | biostudies-literature
Project description:Mild traumatic brain injury (mTBI) is a common problem. Depending on diagnostic criteria, 13 to 62% of those patients develop persistent post-concussion symptoms (PPCS). The main objective of this prospective multi-center study is to derive and validate a clinical decision rule (CDR) for the early prediction of PPCS. Patients aged ≥14 years were included if they presented to one of our seven participating emergency departments (EDs) within 24 h of an mTBI. Clinical data were collected in the ED, and symptom evolution was assessed at 7, 30 and 90 days post-injury using the Rivermead Post-Concussion Questionnaire (RPQ). The primary outcome was PPCS at 90 days after mTBI. A predictive model called the Post-Concussion Symptoms Rule (PoCS Rule) was developed using the methodological standards for CDR. Of the 1083 analyzed patients (471 and 612 for the derivation and validation cohorts, respectively), 15.6% had PPCS. The final model included the following factors assessed in the ED: age, sex, history of prior TBI or mental health disorder, headache in ED, cervical sprain and hemorrhage on computed tomography. The 7-day follow-up identified additional risk factors: headaches, sleep disturbance, fatigue, sensitivity to light, and RPQ ≥21. The PoCS Rule had a sensitivity of 91.4% and 89.6%, a specificity of 53.8% and 44.7% and a negative predictive value of 97.2% and 95.8% in the derivation and validation cohorts, respectively. The PoCS Rule will help emergency physicians quickly stratify the risk of PPCS in mTBI patients and better plan post-discharge resources.
| S-EPMC9529302 | biostudies-literature