Patient Harm

In response to a weight of evidence that patients are frequently harmed as a result of their care, there have been concerted efforts to make healthcare safer, with health systems across the globe investing significant resources in policies and programmes designed to reduce adverse events. Yet, despite extensive efforts, improvements in safety have proved difficult to sustain and spread, with studies confirming there has been no measurable, systems-level improvement in the overall rates of preventable harm. Here, we highlight the limitations of the thinking which underpins current efforts to make healthcare systems safer and point to new and emerging approaches to understanding and addressing patient safety in complex, dynamic health systems.

BackgroundIntensive care unit (ICU) patients are at high risk of anemia, and phlebotomy is a potentially modifiable source of blood loss. Our objective was to quantify daily phlebotomy volume for ICU patients, including blood discarded as waste during vascular access, and evaluate the impact of phlebotomy volume on patient outcomes.MethodsThis was a retrospective observational cohort study between September 2014 and August 2015 at a tertiary care academic medical-surgical ICU. A prospective audit of phlebotomy practices in March 2018 was used to estimate blood waste during vascular access. Multivariable logistic regression was used to evaluate phlebotomy volume as a predictor of ICU nadir hemoglobin ResultsThere were 428 index ICU admissions, median age 64.4 yr, 41% female. Forty-four patients (10%) with major bleeding events were excluded. Mean bedside waste per blood draw (144 draws) was: 3.9 mL from arterial lines, 5.5 mL central venous lines, and 6.3 mL from peripherally inserted central catheters. Mean phlebotomy volume per patient day was 48.1 ± 22.2 mL; 33.1 ± 15.0 mL received by the lab and 15.0 ± 8.1 mL discarded as bedside waste. Multivariable regression, including age, sex, admission hemoglobin, sequential organ failure assessment score, and ICU length of stay, showed total daily phlebotomy volume was predictive of hemoglobin ConclusionA substantial portion of daily ICU phlebotomy is waste discarded during vascular access. Average ICU phlebotomy volume is independently associated with ICU acquired anemia and red blood cell transfusion which supports the need for phlebotomy stewardship programs.

BackgroundThe quality of harms reporting in journal publications is often poor, which can impede the risk-benefit interpretation of a clinical trial. Clinical study reports can provide more reliable, complete, and informative data on harms compared to the corresponding journal publication. This case study compares the quality and quantity of harms data reported in journal publications and clinical study reports of orlistat trials.MethodsPublications related to clinical trials of orlistat were identified through comprehensive literature searches. A request was made to Roche (Genentech; South San Francisco, CA, USA) for clinical study reports related to the orlistat trials identified in our search. We compared adverse events, serious adverse events, and the reporting of 15 harms criteria in both document types and compared meta-analytic results using data from the clinical study reports against the journal publications.ResultsFive journal publications with matching clinical study reports were available for five independent clinical trials. Journal publications did not always report the complete list of identified adverse events and serious adverse events. We found some differences in the magnitude of the pooled risk difference between both document types with a statistically significant risk difference for three adverse events and two serious adverse events using data reported in the clinical study reports; these events were of mild intensity and unrelated to the orlistat. The CONSORT harms reporting criteria were often satisfied in the methods section of the clinical study reports (70-90 % of the methods section criteria satisfied in the clinical study reports compared to 10-50 % in the journal publications), but both document types satisfied 80-100 % of the results section criteria, albeit with greater detail being provided in the clinical study reports.ConclusionsIn this case study, journal publications provided insufficient information on harms outcomes of clinical trials and did not specify that a subset of harms data were being presented. Clinical study reports often present data on harms, including serious adverse events, which are not reported or mentioned in the journal publications. Therefore, clinical study reports could support a more complete, accurate, and reliable investigation, and researchers undertaking evidence synthesis of harm outcomes should not rely only on incomplete published data that are presented in the journal publications.

ObjectiveTo estimate the incidence of avoidable healthcare-associated harm for prisoners in England.DesignA retrospective cross-sectional case note review of prisoner healthcare records.Setting18 prisons in England were purposively sampled for maximum variation of characteristics based on prison category (open, local, training, high security and female), type (publicly and privately run) and population size.PopulationAfter screening 15 027 prisoner records, two cohorts were selected: a sample of 6294 'enhanced risk' prisoners and a random sample of 853 prisoners not included in the enhanced risk sample (n=7147).Main outcome measuresThe primary outcome was the incidence of patient harm per 100 000 patient-years, judged at least probably avoidable. The secondary outcome was the incidence of patient harm judged at least possibly avoidable. Cases of avoidable harm were characterised in terms of patient impact, known as patient outcome(s), and the severity of harm experienced.ResultsWithin 18 prisons, 247 cases of avoidable harm were experienced by 244 prisoners and were identified from 7147 patient records. The incidence of avoidable harm was 2241.4 (95% CI 1970.5 to 2539.0) per 100 000 patient-years, and this rate could be as high as 3412.0 (95% CI 3075.8 to 3774.9) based on the records screened during this study. Most patient outcomes involved prisoners experiencing discomfort and pain (99/247, 40.1%) and delays receiving appropriate healthcare management or assessment (91/247, 36.8%). The identified cases of avoidable healthcare-associated harm for prisoners resulted mainly in moderate harm severity (157/247 cases, 63.6%), followed by severe harm (27, 10.9%) and death (27, 10.9%).ConclusionsCompared with community settings, people in prison experience a 41-67 times greater risk of avoidable significant healthcare-associated harm. This stark disparity underscores the urgent need for government and policy action. Delivering safe, equitable healthcare in secure environments remains a major challenge that demands focused attention.