Haruhisa Fukuda

Factors associated with system-level activities for patient safety and infection control

Abstract Objective We examined the relationship between hospital structural characteristics and system-level activities for patient safety and infection control, for use in designing an incentive structure to promote patient safety. Methods This study utilized a questionnaire to collect institutional data about hospital infrastructure and volume of patient safety activities from all 1039 teaching hospitals in Japan. The patient safety activities were focused on meetings and conferences, internal audits, staff education and training, incident reporting and infection surveillance. Generalized linear modeling was used. Results Of the 1039 hospitals surveyed, 418 (40.2%) hospitals participated. The amount of activities significantly increased by over 30% in hospitals with dedicated patient safety and infection control full-time staff (P <0.001 and P <0.01, respectively). High profit margins also predicted the increase of patient safety programs (P <0.01). Perceived lack of administrative leadership was associated with reduced volume of activities (P <0.05), and the economic burden of safety programs was found to be disproportionately large for small hospitals (P <0.05). Conclusions Hospitals with increased resources had greater spread of patient safety and infection control activities. To promote patient safety programs in hospitals, it is imperative that policy makers require the assignment of dedicated full-time staff to patient safety. Economic support for hospitals will also be required to assure that safety programs are sustainable.

Variations in analytical methodology for estimating costs of hospital-acquired infections: a systematic review

Quantifying the additional costs of hospital-acquired infections (COHAI) is essential for developing cost-effective infection control measures. The methodological approaches to estimate these costs include case reviews, matched comparisons and regression analyses. The choice of cost estimation methodologies can affect the accuracy of the resulting estimates, however, with regression analyses generally able to avoid the bias pitfalls of the other methods. The objective of this study was to elucidate the distributions and trends in cost estimation methodologies in published studies that have produced COHAI estimates. We conducted systematic searches of peer-reviewed publications that produced cost estimates attributable to hospital-acquired infection in MEDLINE from 1980 to 2006. Shifts in methodologies at 10-year intervals were analysed using Fishers exact test. The most frequent method of COHAI estimation methodology was multiple matched comparisons (59.6%), followed by regression models (25.8%), and case reviews (7.9%). There were significant increases in studies that used regression models and decreases in matched comparisons through the 1980s, 1990s and post-2000 (P = 0.033). Whereas regression analyses have become more frequently used for COHAI estimations in recent years, matched comparisons are still used in more than half of COHAI estimation studies. Researchers need to be more discerning in the selection of methodologies for their analyses, and comparative analyses are needed to identify more accurate estimation methods. This review provides a resource for analysts to overview the distribution, trends, advantages and pitfalls of the various existing COHAI estimation methodologies.

Costs of hospital-acquired infection and transferability of the estimates: a systematic review

Hospital-acquired infections (HAIs) present a substantial problem for healthcare providers, with a relatively high frequency of occurrence and considerable damage caused. There has been an increase in the number of cost-effectiveness and cost-savings analyses of HAI control measures, and the quantification of the cost of HAI (COHAI) is necessary for such calculations. While recent guidelines allow researchers to utilize COHAI estimates from existing published literature when evaluating the economic impact of HAI control measures, it has been observed that the results of economic evaluations may not be directly applied to other jurisdictions due to differences in the context and circumstances in which the original results were produced. The aims of this study were to conduct a systematic review of published studies that have produced COHAI estimates from 1980 to 2006 and to evaluate the quality of these estimates from the perspective of transferability. From a total of 89 publications, only eight papers (9.0%) had a high level of transferability in which all components of costs were described, data for costs in each component were reported, and unit costs were estimated with actual costing. We also did not observe a higher citation level for studies with high levels of transferability. We feel that, in order to ensure an appropriate contribution to the infection control program decision-making process, it is essential for researchers who estimate COHAI, analysts who use COHAI estimates for decision-making, as well as relevant journal reviewers and editors to recognize the importance of a transferability paradigm.

Intravenous thrombolysis with recombinant tissue plasminogen activator for ischemic stroke patients over 80 years old: the Fukuoka Stroke Registry.

Objectives The benefit of intravenous recombinant tissue plasminogen activator (rt-PA) therapy for very old patients with acute ischemic stroke remains unclear. The aim of this study was to elucidate the efficacy and safety of intravenous rt-PA therapy for patients over 80 years old. Methods Of 13,521 stroke patients registered in the Fukuoka Stroke Registry in Japan from June 1999 to February 2013, 953 ischemic stroke patients who were over 80 years old, hospitalized within 3 h of onset, and not treated with endovascular therapy were included in this study. Among them, 153 patients were treated with intravenous rt-PA (0.6 mg/kg). For propensity score (PS)-matched case-control analysis, 148 patients treated with rt-PA and 148 PS-matched patients without rt-PA therapy were selected by 1∶1 matching with propensity for using rt-PA. Clinical outcomes were neurological improvement, good functional outcome at discharge, in-hospital mortality, and hemorrhagic complications (any intracranial hemorrhage [ICH], symptomatic ICH, and gastrointestinal bleeding). Results In the full cohort of 953 patients, rt-PA use was associated positively with neurological improvement and good functional outcome, and negatively with in-hospital mortality after adjustment for multiple confounding factors. In PS-matched case-control analysis, patients treated with rt-PA were still at lower risk for unfavorable clinical outcomes than non-treated patients (neurological improvement, odds ratio 2.67, 95% confidence interval 1.61–4.40; good functional outcome, odds ratio 2.23, 95% confidence interval 1.16–4.29; in-hospital mortality, odds ratio 0.30, 95% confidence interval 0.13–0.65). There was no significant association between rt-PA use and risk of hemorrhagic complications in the full and PS-matched cohorts. Conclusions Intravenous rt-PA therapy was associated with improved clinical outcomes without significant increase in risk of hemorrhagic complications in very old patients (aged>80 years) with acute ischemic stroke.

Cost of hospital-wide activities to improve patient safety and infection control: A multi-centre study in Japan

OBJECTIVE The aim of this study was to assess the financial costs to hospitals for the implementation of hospital-wide patient safety and infection control programs. METHODS We conducted questionnaire surveys and structured interviews in seven acute-care teaching hospitals with an established reputation for their efforts towards improving patient safety. We defined the scope of patient safety activities by use of an incremental activity measure between 1999 and 2004. Hospital-wide incremental manpower, material, and financial resources to implement patient safety programs were measured. RESULTS The total incremental activities were 19,414-78,540 person-hours per year. The estimated incremental costs of activities for patient safety and infection control were calculated as US

Change in clinical practice after publication of guidelines on breast cancer treatment

1.100-2.335 million per year, equivalent to the employment of 17-40 full-time healthcare staff. The ratio of estimated costs to total medical revenue ranged from 0.55% to 2.57%. Smaller hospitals tend to shoulder a higher burden compared to larger hospitals. CONCLUSIONS Our study provides a framework for measuring hospital-wide activities for patient safety. Study findings suggest that the total amount of resources is so great that cost-effective and evidence-based health policy is needed to assure the sustainability of hospital safety programs.

The subjective incremental cost of informed consent and documentation in hospital care: a multicentre questionnaire survey in Japan.

OBJECTIVE Several studies raise questions about whether clinical practice guidelines actually guide practice. We evaluated patterns of use of breast-conserving surgery (BCS) over time to examine the effect of guideline publication. DESIGN Retrospective analysis of time-series data on breast cancer treatment. Multiple logistic regression analysis was performed, adjusting for covariates including the patients age, comorbidity status and admission year, to assess whether the use of BCS was higher after publication of treatment guidelines. SETTING Five teaching hospitals participating in the Quality Improvement/Indicator Project (QIP) in Japan. PARTICIPANTS Female breast cancer patients who received surgical treatment at five teaching hospitals from January 1996 through December 2007 (n = 2199). MAIN OUTCOME MEASURE Rates of use of BCS. RESULTS The proportion of BCS use increased from 26.4% before guideline publication to 59.9% after guideline publication in Japan. After controlling for other characteristics, the use of BCS has increased significantly over time, especially since 2001. Women aged 70 years and older (P=0.004) and those with any comorbidity (P < 0.001) were significantly less likely to receive BCS. CONCLUSIONS This study demonstrated that the adjusted proportion of BCS has increased dramatically since 2001, 2 years after guideline publication in Japan and this is consistent with a relationship between guideline publication and a change in this clinical practice.

Identification of Covert Atrial Fibrillation in Cryptogenic Ischemic Stroke: Current Clinical Practice in Japan.

OBJECTIVE To reveal the amount of time and financial cost required to obtain informed consent and to preserve documentation. METHODS The questionnaire was delivered to all staff in six acute care public hospitals in Japan. We examined health care staff perceptions of the time they spent obtaining informed consent and documenting information. All data were collected in 2006 and estimates in the past week in 2006 were compared to estimates of time spent in a week in 1999. We also calculated the economic costs of incremental amounts of time spent in these procedures. RESULTS In 2006, health care staff took about 3.89 hours [95% Confidence Interval (CI) 3.71-4.07] per week to obtain informed consent and 6.64 hours (95% CI 6.40-6.88) per week to write documentation on average. Between 1999 and 2006, the average amount of time for conducting informed consent was increased to 0.67 (P < 0.001) hours per person-week, and the average amount of time for documentation was increased to 0.70 (P < 0.001) hours per person-week. The annual economic cost of activities for informed consent and documentation in a 100-bed hospital increased from 117 755 to 449 402 US dollars. CONCLUSIONS We found a considerable increase in time spent on informed consent and documentation, and associated cost over a 7-year time period. Although greater attention to the informed consent process should be paid to ensure the notions of patient autonomy and self-determination, the increased resources devoted to these practices must be considered in light of current cost containment policies.

Toward the rational use of standardized infection ratios to benchmark surgical site infections

BACKGROUND AND AIM A new insertable cardiac monitor, Reveal LINQ (Medtronic, Dublin, Ireland), was approved for clinical use in Japan in March 2016 for detecting atrial fibrillation in patients who develop ischemic stroke with no clearly definable etiology even after extensive workup, so-called cryptogenic ischemic stroke. Cooperation between a specialist of the Japan Stroke Society and a trained cardiologist or cardiac surgeon is needed both for appropriate patient selection and appropriate management of the device. In this paper, the clinical significance of and diagnostic methods for cryptogenic stroke and covert atrial fibrillation are explained, along with our proposal for the clinical indications for this new device. METHODS, RESULTS, AND CONCLUSION The majority of cryptogenic ischemic strokes are considered to be embolic. In particular, covert atrial fibrillation is drawing attention as the causal emboligenic disease, and it was identified in 30% of patients with long-term observation using an insertable cardiac monitor. Should atrial fibrillation be present, there is a high risk of recurrent stroke, and the cardioembolic stroke that appears is generally severe. The ability to identify atrial fibrillation would be beneficial for preventing stroke recurrence, as anticoagulants can then be used as an established method of secondary prevention. Because the use of insertable cardiac monitors is somewhat invasive, and long-term care systems are also needed, patients suitable for examination using the new device would need to be identified on the basis of detailed diagnostics in accordance withcurrent medical practice in Japan.

Patient-related risk factors for surgical site infection following eight types of gastrointestinal surgery

BACKGROUND The National Healthcare Safety Network transitioned from surgical site infection (SSI) rates to the standardized infection ratio (SIR) calculated by statistical models that included perioperative factors (surgical approach and surgery duration). Rationally, however, only patient-related variables should be included in the SIR model. METHODS Logistic regression was performed to predict expected SSI rate in 2 models that included or excluded perioperative factors. Observed and expected SSI rates were used to calculate the SIR for each participating hospital. The difference of SIR in each model was then evaluated. RESULTS Surveillance data were collected from a total of 1,530 colon surgery patients and 185 SSIs. C-index in the model with perioperative factors was statistically greater than that in the model including patient-related factors only (0.701 vs 0.621, respectively, P < .001). At one particular hospital, for which the percentage of open surgery was lowest (33.2%), SIR estimates changed considerably from 0.92 (95% confidence interval: 0.84-1.00) for the model with perioperative variables to 0.79 (0.75-0.85) for the model without perioperative variables. In another hospital with a high percentage of open surgery (88.6%), the estimate of SIR was decreased by 12.1% in the model without perioperative variables. CONCLUSION Because surgical approach and duration of surgery each serve as a partial proxy of the operative process or the competence of surgical teams, these factors should not be considered predictive variables.