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Table 1 Elements for data collection

From: Incidence, causes, and consequences of preventable adverse drug events: protocol for an overview of reviews

Aspect of data collection Description of key items to be extracted
General review characteristics and patient traits Primary details gathered will include
• Stated review objectives
• Numbers of included studies and patients
• Date ranges of literature searches
• Study eligibility criteria
• Patients’ age distribution (pediatric vs adult vs elderly)
• Diagnoses/comorbidities of patients studied (number and/or cluster of comorbid condition)
• Any other key patient/population information that were noted in the review
Hospital/setting characteristics of each review’s included studies Key setting-related factors for each review’s included studies. Such details will include
• Hospital size characterized by the number of beds and/or the number of staff
• Academic vs community centers
• Clinical disciplines involved in the primary studies
• Geographic locations of the primary studies
• Any other relevant features presented in each review regarding its primary studies
Quantitative measures of incidence of preventable adverse drug events Outcome data collected will include
• Stated eligible measures/definitions of the endpoints assessed in each eligible review, including preventable adverse drugs events and other endpoints related to the current review objectives
• Corresponding incidence rates of primary studies in each review’s included studies (and any presented meta-analysis results thereof, both overall or within specific subgroups of patients)
• Severity assessments as presented for each review’s set of included studies (if reported)
• Causality or likelihood assessments as presented for each review’s set of included studies (if reported)
• Method of collection of adverse event data (i.e., spontaneous vs active surveillance) for each review’s set of included studies (if reported)
Causes of preventable adverse drug events identified among each review’s included studies Causes of interest will include (but not be limited to) the following
• Miscommunications of drug order
• Drug name, label, or packaging problem
• Drug storage or delivery problem
• Environmental, staffing, or workflow problem
• Staff or patient education problem
• Lack of quality control or independent check systems
• Problem with electronic data management system
Consequences of adverse drug events Consequences of interest will include (but not be limited to) proportions of preventable adverse drug events with the following consequences
• No harm done
• Prolonged hospitalization needed
• Life-saving treatment needed
• Hospital readmission
• Emergency department visit readmission
• Transient impact
• Permanent impact
• Quality of life
• Death
• Other outcomes reported
Incidence and types of preventable adverse drug events reported within key subgroups of interest Subgroups of interest include (but are not limited to)
• Clinical specialty (cardiology, oncology, etc.)
• Patient age (e.g., pediatric, adults, elderly)
• Presence of comorbidities
• Healthcare setting