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A protocol for the development and internal validation of a model to predict clinical response to antihistamines in urticaria patients.

ABSTRACT: Chronic urticaria causes a significant limitation to quality of life. In the literature, various studies can be found that have reviewed several clinical and laboratory markers, but none of these variables alone is sufficient to predict the patient's prognosis. In this study, we present a protocol to develop a prognostic model that can predict the clinical response of urticaria patients to antihistamines. This is a protocol for a bidirectional cohort study. Urticaria data will be routinely collected from a population of patients over 18 years old. A full multivariable logistic regression model will be fitted, following five steps: 1) Selection of predictive variables for the model; 2) Evaluation of the quality of the collected data and control of lost data; 3) Data statistical management; 4) Strategies to select the variables to include at the end of the model; 5) Evaluation of the performance of the different possible models (predictive accuracy) and selection of the best model. The performance and internal validation of the model will be assessed. Some clinical and paraclinical variables will be measured for further exploration.

SUBMITTER: Sanchez J

PROVIDER: S-EPMC7537877 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A protocol for the development and internal validation of a model to predict clinical response to antihistamines in urticaria patients.

Sanchez Jorge J Velasquez Margarita M Jaimes Fabian F

PloS one 20201006 10

Chronic urticaria causes a significant limitation to quality of life. In the literature, various studies can be found that have reviewed several clinical and laboratory markers, but none of these variables alone is sufficient to predict the patient's prognosis. In this study, we present a protocol to develop a prognostic model that can predict the clinical response of urticaria patients to antihistamines. This is a protocol for a bidirectional cohort study. Urticaria data will be routinely colle ...[more]

PMID: 33022026

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Project description:ObjectiveTo develop and internally validate the PROgnosis of functional recovery after Trauma (PRO-Trauma) prediction model.DesignA prospective single-center longitudinal cohort study. Patients were assessed at 6 weeks and 12 months post-injury.MethodsPatients that presented at the emergency department with an acute traumatic injury, were prompted for participation. Patients that completed the assessments at 6 weeks and 12 months post injury were included. Exclusion criteria: age < 18, age > 65, pathologic fractures, injuries that resulted in severe neurologic deficits. The predicted outcome, functional recovery, was defined as a Short Musculoskeletal Function Assessment (SMFA-NL) Problems with Daily Activities (PDA) subscale ≤ 12.2 points at 12 months post-injury (Dutch population norm). Predictors were: gender, age, living with partner, number of chronic health conditions, SMFA-NL PDA score 6 weeks post-injury, ICU admission, length of stay in hospital, injury severity score, occurrence of complications and treatment type. All predictors were obtained before 6 weeks post-injury. Missing data were multiply imputed. Predictor variables were selected using backward stepwise multivariable logistic regression. Hosmer-Lemeshow tests were used to evaluate calibration. Bootstrap resampling was used to internally validate the final model.ResultsA total of 246 patients were included, of which 104 (44%) showed functional recovery. The predictors in the final PRO-Trauma model were: living with partner, the number of chronic health conditions, SMFA-NL PDA subscale score at 6 weeks post-injury and length of stay in hospital. The apparent R2 was 0.33 [0.33;0.34], the c-statistic was 0.79 [0.79;0.80]. Hosmer-Lemeshow test indicated good calibration (p = 0.92). Optimism-corrected R2 was 0.28 [0.27;0.29] and the optimism-corrected Area Under the Curve was 0.77 [0.77;0.77].ConclusionThe PRO-Trauma prediction model can be used to obtain valid predictions of attaining functional recovery after trauma at 12 months post-injury. The PRO-Trauma prediction model showed acceptable calibration and discrimination.

Project description:BackgroundAllergic diseases are on the rise in many parts of the world, including the Asia-Pacific (APAC) region. Second-generation antihistamines are the first-line treatment option in the management of allergic rhinitis and urticaria. International guidelines describe the management of these conditions; however, clinicians perceive the additional need to tailor treatment according to patient profiles. This study serves as a consensus of experts from several countries in APAC (Hong Kong, Malaysia, the Philippines, Singapore, Thailand, Vietnam), which aims to describe the unmet needs, practical considerations, challenges, and key decision factors when determining optimal second-generation antihistamines for patients with allergic rhinitis and/or urticaria.MethodsSpecialists from allergology, dermatology, and otorhinolaryngology were surveyed on practical considerations and key decision points when treating patients with allergic rhinitis and/or urticaria.ResultsClinicians felt the need for additional tools for diagnosis of these diseases and a single drug with all preferred features of an antihistamine. Challenges in treatment include lack of clinician and patient awareness and compliance, financial constraints, and treatment for special patient populations such as those with concomitant disease. Selection of optimal second-generation antihistamines depends on many factors, particularly drug safety and efficacy, impact on psychomotor abilities, and sedation. Country-specific considerations include drug availability and cost-effectiveness. Survey results reveal bilastine as a preferred choice due to its high efficacy and safety, suitability for special patient populations, and the lack of sedative effects.ConclusionsCompliance to the international guidelines is present among allergists, dermatologists and otorhinolaryngologists; however, this is lower amongst general practitioners (GPs). To increase awareness, allergy education programs targeted at GPs and patients may be beneficial. Updates to the existing international guidelines are suggested in APAC to reflect appropriate management for different patient profiles and varying symptoms of allergic rhinitis and urticaria.

Project description:PurposeThe prevalence of chronic urticaria (CU) is increasing worldwide, and it imposes a major burden on patients. Few studies have evaluated the efficacy of second-line treatments of CU, particularly for patients being considered for costly third-line treatments such as omalizumab. We compared the efficacy and safety of second-line treatments of CU refractory to standard doses of nonsedating H1-antihistamines (nsAHs).MethodsThis 4-week, prospective, randomized, open-label trial divided patients into 4 treatment groups: 4-fold updosing of nsAHs, multiple combination of 4 nsAHs, switching to other nsAHs, and adjunctive H2-receptor antagonist. The clinical outcomes included urticaria control status, symptoms, and rescue medication use.ResultsThis study included 109 patients. After 4 weeks of second-line treatment, urticaria was well-controlled, partly controlled, and uncontrolled in 43.1%, 36.7%, and 20.2% of patients, respectively. Complete control of CU was achieved in 20.4% of patients. Among the patients with high-dose nsAHs, the proportion with well-controlled status was higher compared to the patients who received standard doses (51.9% vs. 34.5%, P = 0.031). No significant difference was observed in the proportion of well-controlled cases between the updosing and combination treatment groups (57.7% vs. 46.4%, P = 0.616). However, increasing the dose of nsAHs 4-fold was associated with a higher rate of complete symptom control compared to multiple combination treatment with 4 nsAHs (40.0% vs. 10.7%, P = 0.030). Logistic regression analysis confirmed the higher efficacy of updosing of nsAHs for complete control of CU compared to the other treatment strategies (odds ratio, 0.180; P = 0.020).ConclusionsIn patients with CU refractory to standard doses of nsAHs, both updosing of nsAHs 4-fold and multiple combination treatment with 4 nsAHs increased the rate of well-controlled cases without causing significant adverse effects. Updosing of nsAHs is more effective for complete CU control than combination treatment.

Dataset Information

A protocol for the development and internal validation of a model to predict clinical response to antihistamines in urticaria patients.

Publications

A protocol for the development and internal validation of a model to predict clinical response to antihistamines in urticaria patients.

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