Table 1 Elements for data collection
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 |