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Table 2 Quality assessment according to specific criteria on adverse drug events responsible for ICU admission

From: A systematic review of adult admissions to ICUs related to adverse drug events

Item Recommendation Points granted
Title   
Explicit topic One must understand that the article concerns ADE that require ICU admissions 2
Abstract   
Type(s) of ICU studied Describe the type of ICU (for example, medical, surgical) 2
Causality assessment method(s) Indicate the causality assessment method(s) used 2
Proportion of patients admitted to the ICU for ADE The denominator should be the total number of patients admitted in the studied ICU during the observation period 2
Preventability rate of ADE Indicate the estimated preventability rate of ADE 1
Study duration Indicate the study observation period(s) 1
Introduction   
Background Explain the scientific background and rationale for the investigation being reported 2
Objectives State the objectives of the study 2
Methods   
Mandatory   
Description of the study design A prospective patient screening is preferred in order to avoid missing data 3
Type(s) of ICU studied Describe the type of ICU(s) (for example, medical, surgical) 3
Complementary information on the setting environment Indicate the presence of eventual other ICU(s) in the hospital, and mention specific wards (oncology, haematology, geriatrics). This information may help in appraising and understanding results 3
Description of the study size rationale Study size should be argued 3
Definition of ADE The definition of the institute of medicine and recommended by Nebeker and colleagues [4] should be preferred 3
Evaluation of inter-rater reliability for inclusion decision Indicate how inter-rater reliability for inclusion decision was assessed 3
Description of evaluators’ training Describe the profession of evaluators and, if applicable, participation in specific training for the study 3
Description of patients’ screening Describe who was in charge of the patients’ screening and how screening was performed 3
Description of inclusion/exclusion criteria Describe and justify inclusion and exclusion criteria 3
Description of collected data and outcomes measured Collected data should include characteristics of study participants (age, gender, severity score at admission (SOFA/SAPS II), number and classes of drug(s) involved; see items in Results) 3
Description of drug history collecting method Describe the sources of data used for establishing drug history, including all patients’ prescriptions (home, hospital). If possible, the patient or a relative should be questioned to identify all drugs prescribed, all drugs taken in self-medication and drugs prescribed but not taken (inobservance) during the month prior to ICU admission. If patients were already hospitalised before ICU admission, all drugs administered during the hospital stay should be collected 3
Description of causality assessment method(s) Mention the causality assessment method(s) used. Assessment of inter-rater reliability would be welcome 3
Description of preventability method/criteria Mention the criteria used for assessing preventability. Assessment of inter-rater reliability would be welcome 3
Definition of the severity Mention the severity of the ADE: fatal (ADE contributed to death), life-threatening (ADE requiring organ supply) and moderate (ADE only requiring monitoring) 3
Study duration Mention the date of beginning and ending of the study 3
Not mandatory   
Description of statistical analysis (if applicable) Describe all statistical methods, if applicable 0.5
Research of medical causes that contributed to ADE (for preventable drug events) Indicate how the medical causes that contributed to ADE were investigated (that is, drug interactions, contraindications between drugs and patient’s disease, nonappropriate dosage) 0.5
Results   
Mandatory   
Proportion of patients admitted to the ICU for ADE according to the chosen denominator The chosen denominator should be the total number of included patients admitted to the ICU during the study observation period 3
Results for inter-rater reliability for inclusion decision Describe the analysis results of inter-rater agreements/disagreements 3
Description of the characteristics of patients with ADE Describe the studied population: age, gender, severity score at admission, reason for admission, origin of patients (home, hospital) 3
Number and classes of drugs suspected to be involved in the ADE responsible for ICU admission The Anatomical Therapeutic Chemical classification should be used 3
Results for causality assessment Provide all causality assessment results 3
Results for the preventability rate of ADE Indicate the estimated preventability rate of ADE 3
Results for severity of ADE Indicate how many patients died and how many required organ support 3
Results for ICU mortality rate of patients with and without ADE (separately) Indicate and compare the ICU mortality rates of patients with and without ADE. Estimates of the hospital mortality rates for these patients would also be welcome 3
Length of stay in ICU of patients with and without ADE (separately) Indicate and compare the lengths of stay in the ICU for patients with and without ADE 3
Not mandatory   
Results of inter-rater reliability for causality and preventability Describe the analysis results of inter-rater agreements/disagreements 0.5
Research of medical causes that contributed to ADE (for preventable ADE) For preventable ADE, investigations into the medical causes that contributed to ADE, such as prescription despite contraindication, dosage nonappropriate according to weight or specific pathologies (that is, renal impairment) may constitute valuable data to report 0.5
Number of drugs taken by patients with ADE prior to ICU admission The total number of drugs taken by patients with ADE prior to ICU admission would be welcome, as well as drugs prescribed but not taken 0.25
Clinical features of ADE Describe all clinical features of ADE 0.25
Comorbidities of patients with ADE Describe comorbidities of patients with ADE 0.25
Discussion   
Limitations Discuss limitations of the study, taking into account sources of potential bias 2
Interpretation Interpret results and compare with previous studies 2
  1. ADE, adverse drug events; SAPS II, Simplified Acute Physiology Score II; SOFA, Sequential Organ Failure Assessment.