To what extent are adverse events found in patient records reported by patients and healthcare professionals via complaints, claims and incident reports?

<p>Abstract</p> <p>Background</p> <p>Patient record review is believed to be the most useful method for estimating the rate of adverse events among hospitalised patients. However, the method has some practical and financial disadvantages. Some of these disadvantages might be overcome by using existing reporting systems in which patient safety issues are already reported, such as incidents reported by healthcare professionals and complaints and medico-legal claims filled by patients or their relatives. The aim of the study is to examine to what extent the hospital reporting systems cover the adverse events identified by patient record review.</p> <p>Methods</p> <p>We conducted a retrospective study using a database from a record review study of 5375 patient records in 14 hospitals in the Netherlands. Trained nurses and physicians using a method based on the protocol of The Harvard Medical Practice Study previously reviewed the records. Four reporting systems were linked with the database of reviewed records: 1) informal and 2) formal complaints by patients/relatives, 3) medico-legal claims by patients/relatives and 4) incident reports by healthcare professionals. For each adverse event identified in patient records the equivalent was sought in these reporting systems by comparing dates and descriptions of the events. The study focussed on the number of adverse event matches, overlap of adverse events detected by different sources, preventability and severity of consequences of reported and non-reported events and sensitivity and specificity of reports.</p> <p>Results</p> <p>In the sample of 5375 patient records, 498 adverse events were identified. Only 18 of the 498 (3.6%) adverse events identified by record review were found in one or more of the four reporting systems. There was some overlap: one adverse event had an equivalent in both a complaint and incident report and in three cases a patient/relative used two or three systems to complain about an adverse event. Healthcare professionals reported relatively more preventable adverse events than patients.</p> <p>Reports are not sensitive for adverse events nor do reports have a positive predictive value.</p> <p>Conclusions</p> <p>In order to detect the same adverse events as identified by patient record review, one cannot rely on the existing reporting systems within hospitals.</p

The psychometric properties of the 'Hospital Survey on Patient Safety Culture' in Dutch hospitals

BACKGROUND: In many different countries the Hospital Survey on Patient Safety Culture (HSOPS) is used to assess the safety culture in hospitals. Accordingly, the questionnaire has been translated into Dutch for application in the Netherlands. The aim of this study was to examine the underlying dimensions and psychometric properties of the questionnaire in Dutch hospital settings, and to compare these results with the original questionnaire used in USA hospital settings. METHODS: The HSOPS was completed by 583 staff members of four general hospitals, three teaching hospitals, and one university hospital in the Netherlands. Confirmatory factor analyses were performed to examine the applicability of the factor structure of the American questionnaire to the Dutch data. Explorative factor analyses were performed to examine whether another composition of items and factors would fit the data better. Supplementary psychometric analyses were performed, including internal consistency and construct validity. RESULTS: The confirmatory factor analyses were based on the 12-factor model of the original questionnaire and resulted in a few low reliability scores. 11 Factors were drawn with explorative factor analyses, with acceptable reliability scores and a good construct validity. Two items were removed from the questionnaire. The composition of the factors was very similar to that of the original questionnaire. A few items moved to another factor and two factors turned out to combine into a six-item dimension. All other dimensions consisted of two to five items. CONCLUSION: The Dutch translation of the HSOPS consists of 11 factors with acceptable reliability and good construct validity. and is similar to the original HSOPS factor structure. (aut. ref.

New clinical prediction model for early recognition of sepsis in adult primary care patients:a prospective diagnostic cohort study of development and external validation

Background Recognising patients who need immediate hospital treatment for sepsis while simultaneously limiting unnecessary referrals is challenging for GPs.Aim To develop and validate a sepsis prediction model for adult patients in primary care.Design and setting This was a prospective cohort study in four out-of-hours primary care services in the Netherlands, conducted between June 2018 and March 2020.Method Adult patients who were acutely ill and received home visits were included. A total of nine clinical variables were selected as candidate predictors, next to the biomarkers C-reactive protein, procalcitonin, and lactate. The primary endpoint was sepsis within 72 hours of inclusion, as established by an expert panel. Multivariable logistic regression with backwards selection was used to design an optimal model with continuous clinical variables. The added value of the biomarkers was evaluated. Subsequently, a simple model using single cut-off points of continuous variables was developed and externally validated in two emergency department populations.Results A total of 357 patients were included with a median age of 80 years (interquartile range 71–86), of which 151 (42%) were diagnosed with sepsis. A model based on a simple count of one point for each of six variables (aged &gt;65 years; temperature &gt;38°C; systolic blood pressure ≤110 mmHg; heart rate &gt;110/min; saturation ≤95%; and altered mental status) had good discrimination and calibration (C-statistic of 0.80 [95% confidence interval = 0.75 to 0.84]; Brier score 0.175). Biomarkers did not improve the performance of the model and were therefore not included. The model was robust during external validation.Conclusion Based on this study’s GP out-of-hours population, a simple model can accurately predict sepsis in acutely ill adult patients using readily available clinical parameters

Ovarian stimulation for IVF and risk of primary breast cancer in BRCA1/2 mutation carriers

Background: The effect of in vitro fertilisation (IVF) on breast cancer risk for BRCA1/2 mutation carriers is rarely examined. As carriers may increasingly undergo IVF as part of preimplantation genetic diagnosis (PGD), we examined the impact of ovarian stimulation for IVF on breast cancer risk in BRCA1/2 mutation carriers. Methods: The study population consisted of 1550 BRCA1 and 964 BRCA2 mutation carriers, derived from the nationwide HEBON study and the nationwide PGD registry. Questionnaires, clinical records and linkages with the Netherlands Cancer Registry were used to collect data on IVF exposure, risk-reducing surgeries and cancer diagnosis, respectively. Time-dependent Cox regression analyses were conducted, stratified for birth cohort and adjusted for subfertility. Results: Of the 2514 BRCA1/2 mutation carriers, 3% (n = 76) were exposed to ovarian stimulation for IVF. In total, 938 BRCA1/2 mutation carriers (37.3%) were diagnosed with breast cancer. IVF exposure was not associated with risk of breast cancer (HR: 0.79, 95% CI: 0.46–1.36). Similar results were found for the subgroups of subfertile women (n = 232; HR: 0.73, 95% CI: 0.39–1.37) and BRCA1 mutation carriers (HR: 1.12, 95% CI: 0.60–2.09). In addition, age at and recency of first IVF treatment were not associated with breast cancer risk. Conclusion: No evidence was found for an association between ovarian stimulation for IVF and breast cancer risk in BRCA1/2 mutation carriers

Telephone triage in general practices: A written case scenario study in the Netherlands

Objective: General practices increasingly use telephone triage to manage patient flows. During triage, the urgency of the call and required type of care are determined. This study examined the organization and adequacy of telephone triage in general practices in the Netherlands. Design: Cross-sectional observational study using a web-based survey among practice assistants including questions on background characteristics and triage organization. Furthermore, practice assistants were asked to assess the required type of care of written case scenarios with varying health problems and levels of urgency. To determine the adequacy of the assessments, a comparison with a reference standard was made. In addition, the association between background characteristics and triage organization and the adequacy of triage was examined. Setting: Daytime general practices. Subjects: Practice assistants. Main outcome measures: Over- and under-estimation, sensitivity, specificity. Results: The response rate was 41.1% (n = 973). The required care was assessed adequately in 63.6% of cases, was over-estimated in 19.3%, and under-estimated in 17.1%. The sensitivity of identifying patients with a highly urgent problem was 76.7% and the specificity was 94.0%. The adequacy of the assessments of the required care was higher for more experienced assistants and assistants with fixed daily work meetings with the GP. Triage training, use of a triage tool, and authorization of advice were not associated with adequacy of triage. Conclusion: Triage by practice assistants in general practices is efficient (high specificity), but potentially unsafe in highly urgent cases (suboptimal sensitivity). It is important to train practice assistants in identifying highly urgent cases.Key points General practices increasingly use telephone triage to manage patient flows, but little is known about the organization and adequacy of triage in daytime practices. Telephone triage by general practice assistants is efficient, but potentially unsafe in highly urgent cases. The adequacy of triage is higher for more experienced assistants and assistants with fixed daily work meetings with the general practitioner

Examining causes and prevention strategies of adverse events in deceased hospital patients: A retrospective patient record review study in the netherlands

Objective: To improve patient safety and possibly prevent mortality from adverse events (AEs) in hospitals, it is important to gain insight in their underlying causes.We aimed to examine root causes and potential prevention strategies of AEs in deceased hospital patients. Methods: Data on 571 AEs were used from two retrospective patient record review studies of patients who died during hospitalization in the Netherlands. Trained reviewers assessed contributing factors and potential prevention strategies. The results were analyzed together with data on preventability of the AE and the relationship of the AE with the death of the patient. Results: In 47% of the AEs, patient-related causes were identified, in 35% human causes, in 9% organizational causes, and in 3% technical causes. Preventable AEs were caused by technical, organizational, and human causes (78%, 74%, and 74%, respectively) more often than by patientrelated causes (33%). In addition, technical factors caused AEs leading to preventable death (78%) relatively often. Recommended strategies to prevent AEswere quality assurance/peer review, evaluation of safety behavior, improving procedures, and improving information and communication structures. Conclusions: Human failures played an important role in the causation of AEs in Dutch hospitals, because they occurred frequently and they were frequently the cause of preventable AEs. To a lesser extent, latent organizational and technical factors were identified. Patient-related factors were often identified, but the preventability of the AEs with these causes was low. For future research into causes of AEs, we recommend combining record review with interviewing

Covariates of amikacin disposition in a large pediatric oncology cohort.

OBJECTIVE: Amikacin pharmacokinetics (PK) in children display large variability due to maturational and disease-related covariates. The objective was to explore amikacin PK in a large pediatric oncology cohort, taking into account within-patient changes. MATERIALS AND METHODS: Clinical data and amikacin therapeutic drug monitoring (TDM) observations were collected retrospectively from children with an oncology diagnosis receiving amikacin during febrile neutropenia. Individual amikacin PK parameters were calculated using a 1-compartment model with instantaneous input and first-order output. This approach was selected based on a pragmatic study design using TDM from routine clinical care, with availability of 2 TDM samples per treatment episode. To explore covariates of clearance (Cl) and volume of distribution (Vd), linear mixed models were used, modelling a random effect for patient to account for clustering due to repeated measurements. RESULTS: Based on 188 amikacin treatment episodes in 114 patients, median (interquartile range) amikacin Cl was 1.37 (1.05; 2.46) L/h and Vd 7.98 (5.66; 12.73) L. Height and creatinemia were significant covariates for Cl (marginal R2 71.1%), while weight, height, and creatinemia determined Vd (marginal R2 59.5%). CONCLUSION: We described extensive variability of amikacin PK in a large cohort of pediatric oncology patients, including within-patient changes across treatment episodes. Maturational covariates and creatinemia determined amikacin Cl and Vd, while primary non-maturational covariates were not significant. Our observations, based on combined clinical and PK data in children with oncology diagnoses, can be useful to feed dosing software programs to improve drug exposure in special populations.status: Published onlin