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The publication of To Err is Human by the Institute of Medicine (IOM, now the National Academy of Medicine) in 2000 proved to be a watershed moment in healthcare.1 For the first time, national attention focused on flaws in the healthcare system that regularly led to patient harm. The report drew widespread attention from the press and began an important national discussion that continues today. A follow-up report from the IOM in 2004, Patient Safety Achieving a New Standard, recommended a series of sweeping changes.2 Principal among them, the IOM argued that ‘all healthcare organisations should establish comprehensive patient safety programmes operated by trained personnel…’ The main aim of the proposed programme was to create systems for collecting and analysing patient safety data and using the knowledge to reduce risk and prevent future incidents.

Background Hepatocellular carcinoma (HCC) has a high mortality rate, and early detection of HCC improves patient survival. However, the molecular diagnostic markers for early HCC have not been fully elucidated. The aim of this study was to identify novel diagnostic markers for HCC. Methods Serum protein profiles of 45 hepatitis C virus infection (HCV)-related HCC patients (HCV-HCC) were compared to 42 HCV-related chronic liver disease patients without HCC (HCV-CLD) and 21 healthy volunteers using the ProteinChip SELDI system. One of the identified proteins was evaluated as a diagnostic marker for HCC in patients with HCV. Results Five protein peaks (4067, 4470, 7564, 7929, and 8130 m/z) had p-values less than 1 × 10⁻⁷ and were significantly increased in the sera of HCV-HCC patients compared to HCV-CLD patients and healthy volunteers. Among these proteins, an 8130 m/z peak was the most differentially expressed and identified as the complement component 3a (C3a) fragment. For HCV-HCC and HCV-CLD, the relative intensity of this C3a fragment had the best area under the ROC curve [0.70], followed by des-γ-carboxy prothrombin (DCP) [0.68], lectin-bound alpha fetoprotein (AFP-L3) [0.58] and AFP [0.53] for HCC. A combined analysis of the C3a fragment, AFP and DCP led to a 98% positive identification rate. In addition, the measurable C3a fragment in some HCC patients was not only significantly higher in the year of HCC onset compared to the pre-onset year, but also decreased after treatment. Conclusions The 8130 m/z C3a fragment is a potential marker for the early detection of HCV-related HCC.

Aims/hypothesis Our aim was to assess the association of perceived racism with type 2 diabetes, and the possible mediating influence of diet and BMI. Methods The Black Women’s Health Study, a follow-up of 59,000 African-American women, began in 1995. Over 16 years 5344 incident cases of diabetes occurred during 576,577 person-years. Cox proportional hazards models were used to estimated HRs and 95% CIs for categories of ‘everyday racism’ (interpersonal racism in daily life) and ‘lifetime racism’ (reporting ever treated unfairly due to race with respect to police, housing or work) and incident type 2 diabetes. Models were adjusted for age, questionnaire cycle, marital status, socioeconomic status, education, family history of diabetes, physical activity, alcohol use and smoking status, with and without inclusion of terms for dietary patterns and adult BMI. Results Compared with women in the lowest quartile of exposure, women in the highest quartile of exposure to everyday racism had a 31% increased risk of diabetes (HR 1.31; 95% CI 1.20, 1.42) and women with the highest exposure to lifetime racism had a 16% increased risk (HR 1.16; 95% CI 1.05, 1.27). Mediation analysis estimated that BMI accounted for half of the association between either the everyday or lifetime racism measure and incident diabetes. Conclusions/interpretation Perceived everyday and lifetime racism were associated with increased risk of type 2 diabetes in this cohort of African-American women and appear to be at least partly mediated by BMI.

Purpose Procalcitonin (PCT) is an inflammatory marker elevated in bacteremia and bacterial pneumonia. We aimed to assess the real-world diagnostic accuracy of PCT in hospitalized patients with malignancy. Methods A retrospective cohort of 715 patients with cancer who had PCT measured during 750 admissions was analyzed. Diagnosis of bacteremia was determined using blood culture data. Diagnosis of bacterial pneumonia was based on radiographic infiltrate and/or sputum culture. PCT’s performance was assessed using receiver operating characteristic (ROC) curves, sensitivity, and specificity. Results Patients had bacteremia, bacterial pneumonia, or both during 210 admissions (28%). PCT elevation above 0.5 ng/mL was significantly associated with diagnosed infection in the overall population ( p  < 0.0001) and in subgroups with solid tumor malignancies ( p  < 0.0001) and hematologic malignancies ( p  = 0.008). PCT was associated with infectious status in patients with any metastases, but not those with primary lung cancer, lung metastases, neuroendocrine tumors, febrile neutropenia, or history of bone marrow transplant (BMT). The area under the ROC curve for PCT in the overall population was 0.655. An ideal cutoff of 0.21 ng/mL led to a sensitivity of 60% and specificity of 59%. At cutoffs of 0.5 ng/mL and 0.05 ng/mL, PCT’s sensitivity was 39% and 94%, while specificity was 79% and 17%, respectively. Conclusion In this large cohort of hospitalized oncology patients, PCT elevation was associated with diagnosed bacteremia and/or bacterial pneumonia. However, specificity was limited, and PCT elevation was not associated with diagnosed infection in some subpopulations. While PCT may have some diagnostic utility for hospitalized oncology patients, values must be interpreted cautiously and considering clinical context.

Human T lymphotropic virus type I (HTLV-I) is endemic in southern Japan and the Caribbean, but the incidence of HTLV-I-associated diseases varies across geographic areas. We compared markers of disease pathogenesis among 51 ageand sex-matched HTLV-I carrier pairs from Japan and Jamaica. The mean antibody titer (P = .03) and detection of anti-Tax antibody (P = .002) were higher in Jamaican subjects than in Japanese subjects, but provirus load was similar between the 2 groups (P = .26). The correlation between antibody titer and provirus load was more prominent among Jamaican subjects than among Japanese subjects (P = .06). These findings underscore the differences in host immune response to HTLV-I infection in 2 populations.

Objective. To understand the extent to which hospitalized patients participate in their care, and the association of patient participation with quality of care and patient safety. Design. Random sample telephone survey and medical record review. Setting. US acute care hospitals in 2003. Participants. A total of 2025 recently hospitalized adults. Main Outcome Measures. Hospitalized patients reported participation in their own care, assessments of overall quality of care and the presence of adverse events (AEs) in telephone interviews. Physician reviewers rated the severity and preventability of AEs identified by interview and chart review among 788 surveyed patients who also consented to medical record review. Results. Of the 2025 patients surveyed, 99.9% of patients reported positive responses to at least one of seven measures of participation. High participation (use of > 4 activities) was strongly associated with patients' favorable ratings of the hospital quality of care (adjusted OR: 5.46, 95% CI: 4.15-7.19). Among the 788 patients with both patient survey and chart review data, there was an inverse relationship between participation and adverse events. In multivariable logistic regression analyses, patients with high participation were half as likely to have at least one adverse event during the admission (adjusted OR = 0.49,0.31-0.78). Conclusions. Most hospitalized patients participated in some aspects of their care. Participation was strongly associated with favorable judgments about hospital quality and reduced the risk of experiencing an adverse event.

BACKGROUNDEvidence suggests that patients can report a variety of adverse events (AEs) not captured by traditional methods such as a chart review. Little is known, however, about whether patient reports are useful for measuring patient safety. OBJECTIVESTo examine the degree to which physician reviewers agreed that patient reports of “negative effects” constituted AEs, and to identify questionnaire items that affected reviewersʼ judgments. METHODSWe surveyed patients discharged from Massachusetts hospitals in 2003 to elicit information about negative effects associated with hospitalization. Physician reviewers judged whether patient-reported negative effects represented AEs, and classified the severity of the event. Likelihood ratios were calculated to assess whether patient responses to questionnaire items affected reviewersʼ judgments. RESULTSOf the 2582 patients surveyed, 753 patients reported 1170 negative effects, and 71.2% of these effects were classified as AEs by physician reviewers. Negative effects most likely to be classified as AEs involved newly prescribed medications and changes to previously prescribed medications. Additional information elicited from follow-up survey questions modestly affected reviewersʼ classification of serious AEs. Negative effects reported by women, younger patients, those reporting better health status, and those not admitted through the emergency department were more likely to be classified as AEs. CONCLUSIONSMany patients were able to identify care-related AEs. Patient responses to questions about the sequelae of the events provided limited additional information for physicians to use in gauging the presence and severity of the event. Patient reports complement other incident-detection methods by providing information that is credible and unavailable from other sources.

BACKGROUND: Pain is common among cancer patients. OBJECTIVE: To characterize the incidence of severe pain among newly diagnosed patients with stage IV cancer in ambulatory care. METHODS: A retrospective cohort of 505 ambulatory oncology patients with newly diagnosed stage IV solid tumours at a comprehensive cancer centre (Dana‐Farber Cancer Institute, Boston, Massachusetts, USA) was followed from January 1, 2004, to December 31, 2006. Pain intensity scores were extracted from electronic medical records. The incidence of severe pain was calculated using the maximum monthly pain scores reported at outpatient visits. RESULTS: Of the 505 patients included in the present study, 340 (67.3%) were pain‐free at the initial visit, 90 (17.8%) experienced mild pain, 48 (9.5%) experienced moderate pain and 27 (5.4%) experienced severe pain. At least one episode of severe pain within one year of diagnosis was reported by 29.1% of patients. Patients with head and neck, gastrointestinal and thoracic malignancies were more likely to experience severe pain compared with patients with other types of cancer (52.6%, 33.9% and 30.5%, respectively). In the multivariable model, patients whose primary language was not English (OR 2.90 [95% CI 1.08 to 7.80]), patients who reported severe pain at the initial visit (OR 9.30 [95% CI 3.72 to 23.23]) and patients with head and neck (OR 10.17 [95% CI 2.87 to 36.00]) or gastrointestinal (OR 4.05 [95% CI 1.23 to 13.35]) cancers were more likely to report severe pain in the following year. CONCLUSIONS: The incidence of severe pain was high in ambulatory patients with newly diagnosed stage IV cancer.

BACKGROUND:Theories of stress-induced metabolic syndrome predict that job strain would increase risk. Few studies have evaluated this association. OBJECTIVE:To evaluate the association between job strain and the risk of metabolic syndrome. METHODS:We investigated associations between job strain and incident metabolic syndrome adjusted for sociodemographic factors, health behaviors, and depressive symptoms over 5 years among 2966 black and white men and women in the Coronary Artery Risk Development in Young Adults study. Job strain was categorized by Karasekʼs modelhigh demands/low control; high demands/high control; low demands/low control; and low demands/high control. RESULTS:Compared with persons in low-strain jobs, men in active jobs (adjusted hazards ratio, 2.7; 95% confidence interval, 1.5 to 4.9) and women in high strain jobs (adjusted hazards ratio, 2.2; 95% confidence interval, 1.0 to 4.6) had significantly increased risk of metabolic syndrome. CONCLUSION:Job strain may be a modifiable risk factor for metabolic syndrome and subsequent cardiovascular disease.

The clinical features of hepatitis C virus (HCV) carriers with persistently normal alanine aminotransferase (PNALT) levels (ALT < or = 34 IU/l) have not been fully elucidated. We investigated clinical factors associated with ALT flare-up in PNALT individuals in a HCV hyperendemic area of Japan. We analyzed 101 HCV carriers who had PNALT between 1993 and 2000. The first occurrence of ALT flare-up (ALT > or = 35 IU/l) between 2001 and 2005 was evaluated by the Kaplan-Meier method. Multivariate analysis of factors predicting ALT flare-up were conducted using Cox proportional hazards models. The mean follow-up period was 2.8 years, and the 5-year cumulative incidence of ALT flare-up was estimated to be 31.8%. In multivariate analysis, an ALT level of 20-34 IU/l and a high serum ferritin level (> or =90 ng/ml) in the most recently available data up to the year 2000, as well as H63D heterozygosity in the HFE gene, were independently and strongly associated with the incidence of ALT flare-up (Hazard ratios = 5.6, 3.1, and 4.8, respectively). In addition, HFE H63D heterozygosity was significantly associated with higher serum ferritin levels in subjects with PNALT (153.8 + or - 73.3 ng/ml in subjects with the 63HD genotype vs. 89.4 + or - 51.3 ng/ml in subjects with the 63HH genotype, P = 0.043). HCV carriers with PNALT in this population were at risk for ALT flare-up. Basal ALT levels, serum ferritin levels, and HFE polymorphism are potentially important predictors of ALT flare-up.