A content analysis of contributory factors reported in serious incident investigation reports in hospital care.

BACKGROUND: Serious incident (SI) investigations aim to identify factors that caused or could have caused serious patient harm. This study aimed to use the Human Factors Analysis and Classification System (HFACS) to characterise the contributory factors identified in SI investigation reports. METHODS: We performed a content analysis of 126 investigation reports from a multi-site NHS trust. We used a HFACS-based framework that was modified through inductive analysis of the data. RESULTS: Using the modified HFACS framework, 'unsafe actions' were the most commonly identified hierarchical level of contributory factors in investigation reports, which were identified 282 times across 99 (79%) incidents. 'Preconditions to unsafe acts' (identified 223 times in 91 (72%) incidents) included miscommunication and environmental factors. Supervisory factors were identified 73 times across 40 (31%) incidents, and organisational factors 115 times across 59 (47%) incidents. We identified 'extra-organisational factors' as a new HFACS level, though it was infrequently described. CONCLUSIONS: Analysis of SI investigation reports using a modified HFACS framework allows important insights into what investigators view as contributory factors. We found an emphasis on human error but little engagement with why it occurs. Better investigations will require independence and professionalisation of investigators, human factors expertise, and a systems approach.

The clinical and phenotypical assessment of seronegative villous atrophy; a prospective UK centre experience evaluating 200 adult cases over a 15-year period (2000-2015).

BACKGROUND: Seronegative villous atrophy (SNVA) is commonly attributed to coeliac disease (CD). However, there are other causes of SNVA. More recently angiotensin-2-receptor-blockers (A2RBs) have been reported as an association but data on SNVA have been limited to centres evaluating complex case referrals and not SNVA in general. OBJECTIVES: To provide clinical outcomes and associations in a large prospective study overseeing all newcomers with SNVA. DESIGN: Over a 15-year period (2000-2015) we evaluated 200 adult patients with SNVA at a UK centre. A diagnosis of either seronegative CD (SNCD) or seronegative non-CD (SN-non-CD) was reached. Baseline comparisons were made between the groups, with 343 seropositive CD subjects serving as controls. RESULTS: Of the 200 SNVA cases, SNCD represented 31% (n=62) and SN-non-CD 69% (n=138). The human leucocyte antigen (HLA)-DQ2 and/or DQ8 genotype was present in 61%, with a 51% positive predictive value for SNCD. The breakdown of identifiable causes in the SN-non-CD group comprised infections (27%, n=54), inflammatory/immune-mediated disorders (17.5%, n=35) and drugs (6.5%, n=13; two cases related to A2RBs). However, no cause was found in 18% (n=36) and of these 72% (n=26/36) spontaneously normalised duodenal histology while consuming a gluten-enriched diet. Following multivariable logistic regression analysis an independent factor associated with SN-non-CD was non-white ethnicity (OR 10.8, 95% CI 2.2 to 52.8); in fact, 66% of non-whites had GI infections. On immunohistochemistry all groups stained positive for CD8-T-cytotoxic intraepithelial lymphocytes. However, additional CD4-T helper intraepithelial lymphocytes were occasionally seen in SN-non-CD mimicking the changes associated with refractory CD. CONCLUSIONS: Most patients with SNVA do not have CD, in particular those who are not white. Furthermore, a subgroup with no obvious aetiology will show spontaneous histological resolution while consuming gluten. These findings suggest caution in empirically prescribing a gluten-free diet without investigation.