Safety assessments patient records

Another approach uses a synthesis of RCTs and naturalistic studies, while addressing the limitations of both (Simon et al, 1995b Hotopf et al, 1996). In such studies the treatment setting is routine primary-care clinical practice selection criteria are limited to those affecting safety and treatment is normal , i.e. provided under conditions where differences in clinical practice and patient behaviour can emerge freely. However, participants are randomized to initial treatment, and accurate diagnosis and baseline assessments are recorded. This approach is... 

Another method of differentiation relates to those affected. Others are always harmed by fraud, whereas in some cases of misconduct there may be no obvious victims. Foremost among those harmed by fraud are patients or research subjects who may have received unnecessary treatment, not had full safety assessments while taking an experimental drug or been entered into a study about which they knew nothing. Patient records may have been altered to show untrue diagnoses to make them appear eligible for the study this often remains uncorrected. 

All fraud is also misconduct by definition, but misconduct per se is not so clear-cut. It could be accidental, for example missing the due date for patient assessments, or carelessly completing case record forms, but the point where carelessness becomes misconduct and misconduct becomes fraud is indistinct. A safety assessment might be omitted because the research team forgot... 

Managing reference data can be particularly troublesome when two or more systems are merged for example when two local systems are being replaced by a single alternative and there is a need to preserve historical cliifical data. Each system is likely to have its own reference data and, particularly over time, it is common for these datasets to have similar purposes but with different content. For example, a Patient Administration System may have five different options for Admission type whilst the Electronic Health Record may have seven different options for that same field. Whilst it might be possible to live with this discrepancy on a day-to-day basis, the situation suddenly becomes very complex when it is necessary to merge the two datasets. Any proposed solutions need a careful safety assessment. 

Few studies have directly compared the safety of the various available colony-stimulating factors. The frequency and severity of adverse effects associated with the prophylactic use of filgrastim (a bacterial cell-derived G-CSF) or sargramostim (a yeast cell-derived GM-CSF) have been assessed in a retrospective review of the medical records of 490 cancer patients from 10 centers (9). 

Retrospective reviews of medical records aim to assess the nature, incidence and economic impact of adverse events and to provide some information on their causes. Adverse events are defined as an unintended injury caused by medical management rather than the disease process that results in some definite injury or, at the very least, spent on additional days in hospital (Box 4.1). Definitions are critical in patient safety and one has to be constantly aware of differences in terminology. For instance, a study by Andrews et al. (1997) in the United States showed a 17.7% rate of serious adverse events in a surgical unit, much higher than most other studies. However, their definition of adverse event was different from that usually employed and they used observation rather than record review, as most other studies do. These are not flaws the study is a good one. The point is... 

Several instruments have been developed to assess hospital staff s perceptions of aspects of workplace safety culture and a number of studies have reported associations between hospital safety culture and safety outcome measures (Jackson et al. 2010). Profiling the hospital safety culture scores is relatively straightforward but finding safety outcome measures for patients or workers is more challenging (Flin 2007). Different types of safety outcome data can be collected, e.g. (i) hospital incident records for staff or patients or clinical data for patients, (ii) self-reports of incidents and injuries by workers or patients and (iii) workers safety behaviours (self-reported or observed). 

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