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Selecting short-statured children needing growth hormone testing: derivation and validation of a clinical decision rule.

ABSTRACT: 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.

SUBMITTER: Duche L

PROVIDER: S-EPMC2492843 | biostudies-other | 2008

REPOSITORIES: biostudies-other

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Selecting short-statured children needing growth hormone testing: derivation and validation of a clinical decision rule.

Duché Laëtitia L Trivin Christine C Chemaitilly Wassim W Souberbielle Jean Claude JC Bréart Gérard G Brauner Raja R Chalumeau Martin M

BMC pediatrics 20080716

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 18631396

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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.

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.

Project description:BackgroundA quarter of all patients presenting to emergency departments are children. Although there are several large, well-conducted studies on adults enabling accurate selection of patients with head injury at high risk for computed tomography scanning, no such study has derived a rule for children.AimTo conduct a prospective multicentre diagnostic cohort study to provide a rule for selection of high-risk children with head injury for computed tomography scanning.DesignAll children presenting to the emergency departments of 10 hospitals in the northwest of England with any severity of head injury were recruited. A tailor-made proforma was used to collect data on around 40 clinical variables for each child. These variables were defined from a literature review, and a pilot study was conducted before the children's head injury algorithm for the prediction of important clinical events (CHALICE) study. All children who had a clinically significant head injury (death, need for neurosurgical intervention or abnormality on a computed tomography scan) were identified. Recursive partitioning was used to create a highly sensitive rule for the prediction of significant intracranial pathology.Results22,772 children were recruited over 2 1/2 years. 65% of these were boys and 56% were <5 years old. 281 children showed an abnormality on the computed tomography scan, 137 had a neurosurgical operation and 15 died. The CHALICE rule was derived with a sensitivity of 98% (95% confidence interval (CI) 96% to 100%) and a specificity of 87% (95% CI 86% to 87%) for the prediction of clinically significant head injury, and requires a computed tomography scan rate of 14%.ConclusionA highly sensitive clinical decision rule is derived for the identification of children who should undergo computed tomography scanning after head injury. This rule has the potential to improve and standardise the care of children presenting with head injuries. Validation of this rule in new cohorts of patients should now be undertaken.

Project description:BackgroundTo date, the Pediatric Emergency Care Applied Research Network (PECARN) rule for identifying children who are at very low risk of clinically-important traumatic brain injuries after minor head trauma has not been validated prospectively in an independent population. Our goal was to evaluate the diagnostic performance of the PECARN clinical decision rule in a French pediatric population in multiple clinical settings.MethodsWe conducted a multicenter, prospective, non-interventional cohort study of patients with minor head trauma who presented to three emergency departments in France. We enrolled patients younger than 16 years of age seeking a consultation within 24 h of head trauma with Glasgow Coma Scale scores of 14-15.ResultsDuring the study period, we included 1499 children of which 421 (28 %) were under 2 years of age, and 955 (64 %) were male. A cranial computed tomography (CT) scan was performed on 76 patients (5.1 %). Of the 1499 included patients, 9 children (0.6 %) had a clinically-important traumatic brain injury, and none were classified as very low risk by the PECARN rule. In our study, the sensitivity of this clinical decision rule was 100 % (95 % CI 66.4 to 100 %), the specificity was 69.9 % (95 % CI 67.5 to 72.2 %) and the negative predictive value was 100 % (95 % CI 99.7 to 100 %).DiscussionOur study confirmed the good predictive performances of the PECARN clinical decision rule for minor head trauma in children. The PECARN rule performed similarly to our study and to its internal validation study.ConclusionsWe conducted an external validation study of the PECARN clinical decision rule for the detection of clinically-important traumatic brain injuries in children with minor head trauma, according to the methodological standards. The PECARN rule successfully identified all patients with clinically-important traumatic brain injuries, with a limited use of CT scans. Conducting a broad validation study with a large cohort is a prerequisite to provide sufficient statistical power before authorizing its implementation and generalization.Trial registrationThis study has been registered in ClinicalTrials.gov with identifier number: NCT02752711 on April 27, 2016.

Project description:ObjectivesTo develop and validate a simple clinical prediction rule, based on variables easily measurable at admission, to identify patients at high risk of developing delirium during their hospital stay on an internal medicine ward.DesignProspective study of two cohorts of patients admitted between 1 May and 30 June 2008 (derivation cohort), and between 1 May and 30 June 2009 (validation cohort).SettingA tertiary hospital in Donostia-Gipuzkoa (Spain).ParticipantsIn total 397 patients participated in the study. The mean age and incidence of delirium were 75.9 years and 13%, respectively, in the derivation cohort, and 75.8 years and 25% in the validation cohort.Main outcome measuresThe predictive variables analysed and finally included in the rule were: being aged 85 years old or older, being dependent in five or more activities of daily living, and taking two or more psychotropic drugs (antipsychotics, benzodiazepines, antidepressants, anticonvulsant and/or antidementia drugs). The variable of interest was delirium as defined by the short Confusion Assessment Method, which assesses four characteristics: acute onset and fluctuating course, inattention, disorganised thinking and altered level of consciousness.ResultsWe developed a rule in which the individual risk of delirium is obtained by adding one point for each criterion met (age?85, high level of dependence, and being on psychotropic medication). The result is considered positive if the score is ?1. The rule accuracy was: sensitivity=93.4% (95% CI 85.5% to 97.2%), specificity=60.6% (95% CI 54.1% to 66.8%), positive predictive value=44.4% (95% CI 36.9% to 52.1%) and negative predictive value=96.5% (95% CI: 92% to 98.5%). The area under the receiver operator characteristic (ROC) curve was 0.85 for the validation cohort.ConclusionsThe presence or absence of any of the three predictive factors (age?85, high level of dependence and psychotropic medication) allowed us to classify patients on internal medicine wards according to the risk of developing delirium. The simplicity of the variables in our clinical prediction rule means that the data collection required is feasible in busy medicine units.

Dataset Information

Selecting short-statured children needing growth hormone testing: derivation and validation of a clinical decision rule.

Publications

Selecting short-statured children needing growth hormone testing: derivation and validation of a clinical decision rule.

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