The Israeli Study of Surgical Infections (ISSI): I. Methods for developing a standardized surveillance system for a multicenter study of surgical infections

The postoperative wound infection experience in 11 Israeli hospitals was investigated with two objectives: (1) to utilize the variability among hospitals for a better understanding of the determinants of these infections, and (2) to present surgeons and infection control teams with information upon which they can take action. This article summarizes the methods that were applied to maximize the uniformity of information obtained from hospitals. (1) The same kind of patients were sampled in every hospital. (2) The data collection system was standardized, and analyzed for errors. The overall error rate was small (2%) but there were potential problem areas, such as missing information on underlying diagnoses (12%). Few errors (1%) were found in the nurses' observations of the wounds. (3) All wound infections were diagnosed in a uniform manner by convening a panel of four specialists at the central Israeli Study of Surgical Infections (ISSI) office. (4) The definition of infection that was finally chosen for this multicenter study had to be broadened to include, in addition to pus, "discharge other than pus," because of the higher reliability among panel members. This definition was also clinically valid in terms of morbidity. (5) The rate of postdischarge infections was estimated and was not found to be related to the discharge policies in the various hospitals.     

The Israeli Study of Surgical Infections (ISSI): II. Initial comparisons among hospitals with special focus on hernia operations

In a study of 5,571 patients from the general surgery departments of 11 Israeli hospitals, the crude overall wound infection rates showed interhospital heterogeneity. The rates ranged from 6.3% to 12.4% (P(chi 2) = 0.039). Controlling for the different distributions of procedures performed in the various institutions did not reduce this variability. None of the hospitals had either consistently high or consistently low infection rates. A hospital could have low rates for one procedure and high rates for another. Therefore, the decision was made to proceed with procedure-specific analyses. This article details results of the analysis of 1,487 hernia operations. Four variables (old age, infection at another site, incarceration, and introduction of drains) accounted for almost all the differences in infection rates among the institutions. Of the four, presence of drains had the strongest association with infection (P derived from the logistic model less than 0.001). The risk was consistent in all hospitals and was unconfounded by other measurable factors. In contrast, the pattern of using drains seemed arbitrary and inconsistent, ranging from 9% of patients in one hospital to 41% in another. These findings were used as a basis for discussion with the surgical teams and for the initiation of a randomized clinical trial on the use of drains in hernia operations.     

Discharge from hospital and its effect on surgical wound infections. The Israeli Study of Surgical Infections (ISSI).

A multicenter study of 2846 consecutive hernia operations was conducted to identify risk factors for infections that occurred during the hospitalization and post-discharge from hospital. Operated patients were followed-up for 30 days after surgery, whether at home or still hospitalized, and half the wound infection episodes were found to occur at home. Risk factors for both in-hospital and post-discharge infections seemed to be influenced by; (a) the selective nature of discharge, (b) the differential effect some risk factors had on either early or late infections. On any given day, patients selected by the clinical team to remain in hospital were more "at risk" for infection than those who left. As a result, they had a better chance of being diagnosed as infected during hospitalization. By contrast, those who were discharged home were perceived as low risk for complications. Subsequent infections in these patients occurred either due to factors "causing" late infections, therefore, unappreciated at the time of discharge, or unknown risk factors. More study risk factors were associated with in-hospital than with post-discharge infections, especially those associated with "early" infections. The implications of these findings for future evaluations of medical care in hospitalized patients are discussed.     

A trend for reduced 15-day wound infection and 6 months' mortality in laparoscopic relative to open cholecystectomy: the Israeli Study of Surgical Infections

OBJECTIVE: To utilize a naturally occurring "experiment," when introduction to laparoscopic cholecystectomy occurred in Israel; to compare the concurrent outcomes (wound infection and mortality) of laparoscopic versus open cholecystectomy; to adjust for patients' characteristics and procedural factors while making the comparisons. DESIGN: Multicenter prospective follow up, including patients' interviews prior to the operation, daily information on postoperative care, a summary of the operation report and postdischarge telephone interview 15 days after surgery. SETTINGS: A sample of 100 consecutive cholecystectomy patients from all 20 acute-care hospitals in the country, where such operations were performed. PATIENTS: 1,785 consecutive patients during 1991 and 1992; 1,184 had open cholecystectomy, and 601 had laparoscopic cholecystectomy. RESULTS: Crude wound infection rates at 15 days were 2.3% for laparoscopic cholecystectomy and 6.3% for open cholecystectomy (odds ratio [OR], 2.8; P < .001). Crude mortality rates at 6 months were 0.17% and 3.0% for laparoscopic and open procedures, respectively (OR, 18.5; P < .004). Logistic models for infection and mortality were used to adjust for case-mix and procedural factors in the comparisons between the two operations. Adjusted ORs for open versus laparoscopic cholecystectomy were 1.9 (P = .06) for wound infection and 4.3 (P = .17) for mortality. Stratification of patients on the basis of the models into high- and low-risk strata indicated that the protective effect of laparoscopic cholecystectomy was mainly evident in the high-risk group: 1.8% versus 8.3% (P < .001) for 15-day infections and 0.6% versus 4.4% (P = .017) for 6 months mortality. CONCLUSION: We conclude that, although the P values for the adjusted comparisons were of borderline significance (due to the small number of deaths in the laparoscopic group), our results suggest advantageous outcomes for laparoscopic cholecystectomy, especially among the high-risk patients.     

切口感染调查与分析

目的：探讨外科术后切口感染的相关因素。方法：采用前瞻性调查与回顾性调查相结合，对术后切口感染病例作重点监测。结果：伤口类型、手术方式、外环境因素、个体差异与术后切口感染呈相关性。结论：术前充分准备，严格无菌操作，改善外环境与个体条件可预防术后切口感染的发生。     

开腹阑尾切除术手术部位感染危险因素病例对照研究

目的探讨开腹阑尾切除术手术部位感染危险因素。方法对开腹阑尾切除术患者采用1∶2配比进行病例对照研究,对危险因素进行单因素和多因素条件Logistic回归分析。结果单因素条件Logistic回归结果显示麻醉类型、ASA分级、糖尿病、切口类型、手术持续时间、术前白细胞计数、失血量、住院天数等因素差异有统计学意义;多因素回归模型筛选出麻醉类型、糖尿病、切口类型、手术持续时间等因素差异有统计学意义。结论全麻、糖尿病、污染切口、手术持续时间60min等暴露因素为开腹阑尾切除术手术部位感染的危险因素。     

The sleeping giant stirs: growth in multihospital systems

Because their future is interwoven with the Church's broader role, Catholic multihospital systems must not grow solely for efficiency's sake. On the following pages the authors analyze data showing a direct shift toward a new form of health care delivery and suggest that system types, organization structures, and objectives should reflect and enhance Gospel values.     

Comparative incidence dynamics and serotypes of meningitis,bacteremic pneumonia and other-IPD in young children in the PCV era: Insights from Israeli surveillance studies

IntroductionWidespread introduction of pneumococcal conjugated vaccines (PCVs) impacted on invasive pneumococcal disease (IPD). However, IPD reduction may not be similar in all outcomes within IPD.We assessed PCV7/PCV13 impact on pneumococcal meningitis, bacteremic pneumonia (BP) and other (non-meningitis, non-pneumonia) IPD episodes in children <5 years in Israel.MethodsA prospective, population-based, active nationwide surveillance.All pneumococcal invasive episodes with positive blood/CSF cultures, July 2000 through June 2016, were included. Three sub-periods were defined: pre-PCV (2000–2008), PCV7 (2009–2011) and PCV13 (2014–2016). Incidence rate ratios (IRRs) were calculated.ResultsOverall, 4321 episodes were recorded; 456 (10.6%) meningitis, 1478 (34.2%) pneumonia and 2387 (55.2%) other-IPD.In the pre-PCV period, proportion of serotypes in PCV13, but not in PCV7 (mainly serotypes 1, 5 and 19A) was higher in BP (43.3%) compared with other-IPD episodes (32.8%, p < 0.001) and similar to that of meningitis (37.6%, p = 0.1). The proportion of episodes in children <12 months was higher in meningitis (52.1%) compared with pneumonia (23.2%) and other-IPD episodes (39.5%; p < 0.001 for both).The declines of the 3 entities were not similar; Meningitis rate non-significantly declined by 24% (IRR = 0.76; 95% CI 0.57–1.01), while BP and other-IPD rates significantly declined by 57% and 70%, respectively. In contrast to other entities, BP did not decline significantly after PCV7 introduction but started to decline only after PCV13 introduction.Rates of meningitis, pneumonia and other-IPD caused by PCV13-serotypes (VT13) substantially declined by 88%, 95% and 97%, respectively, comparing PCV13 and the pre-PCV periods. However, diseases caused by non-VT13 increased by 256%, 302% in meningitis and pneumonia, respectively, but only 116% in other-IPD.ConclusionsFollowing PCV7/PCV13 introduction, rates of episodes caused by VT13 were substantially reduced in all 3 groups. However, differences in age distribution, serotype replacement and specific serotype decrease suggest different pathogenesis and host susceptibility between the 3 entities.     

Cohort studies: History of the method I. prospective cohort studies

The term "cohort study" was introduced by Frost in 1935 to describe a study that compared the disease experience of people born at different periods, in particular the sex and age specific incidence of tuberculosis and the method was extended to the study of non-communicable disease by Korteweg who used it 20 years later to analyse the epidemic of lung cancer in the Netherlands. Such studies are now best described as generation studies or generation cohort studies to distinguish them from the common type of study that is now carried out that consists in defining groups of individuals distinguished by some variable (such as place of residence, occupation, behaviour, or environmental exposure) and following them up to see if the incidence or mortality rates vary with the selected variable. This type of study is now one of the most important tools for epidemiological investigation. Initially called prospective studies, because the information characterising the individuals in the cohorts was recorded before the onset of disease, they are now preferably called cohort studies and distinguished as prospective cohort studies, If the information obtained relates to the subjects at the time the study is started and they are then followed, or retrospective cohort studies, if the information characterising the individuals was recorded sometime in the past (for example, the receipt of radiotherapy, or entry to a specific occupation). Studies of either type have the great advantage that they avoid all the most important sources of bias that may affect case-control-studies, but the disadvantage that because incidence rates and more specifically mortality rates are commonly low, large numbers of subjects have to be followed for several (if not many) years to obtain statistically significant results. Several early prospective studies are described: Namely, those of 34,000 male British doctors, 190,000 male and female American citizens with different smoking habits, some 5,000 middle aged residents of Framingham with different blood pressures, blood cholesterol levels, etc, and 13,000 children born in the UK in one week in 1946 with different family backgrounds.     

The logistic analysis of epidemiologic prospective studies: investigation by simulation

We performed a Monte Carlo computer simulation of the Walker-Duncan logistic regression technique in a typical epidemiologic prospective setting and analysed the results with respect to the accuracy and reliability of the regression estimates and the associated statistical significance tests (Z-tests). The results strongly suggest that the estimates were neither accurate nor reliable. The magnitude of the difference between the average estimated regression coefficient and its true population value did not necessarily decrease as the sample size increased. The average estimated standard deviation of the estimate of the regression coefficient either overestimated or underestimated the actual standard deviation, the former occurring most, but not all, of the time. The significance tests (a two-tailed Z-test with a significance level of 0.05) had actual type I errors ranging from 0.00 to 0.24 for different samples. This approach is therefore inadequate as an epidemiologic tool for analysis of a Framingham-type prospective study. Further simulation studies are indicated.     

Early impact of sequential introduction of 7-valent and 13-valent pneumococcal conjugate vaccine on IPD in Israeli children <5 years: An active prospective nationwide surveillance

BackgroundThe 7-valent pneumococcal conjugated vaccine (PCV7) was introduced to the Israeli national immunization plan (NIP) in July 2009 (administered at age 2, 4 and 12 months), with a fast reduction of invasive pneumococcal disease (IPD) caused by PCV7 serotypes. Starting in November 2010, PCV13 gradually replaced PCV7.AimTo report the impact of PCV7/PCV13 sequential introduction on IPD in Israeli children <5 years.MethodsAn ongoing nationwide, prospective, population-based, active surveillance. All IPD episodes (Streptococcus pneumoniae isolated from blood and/or cerebrospinal fluid) from July 2004 through June 2013 were included.ResultsOverall, 2670 IPD episodes were recorded. Incidence of IPD caused by PCV7 + 6A serotypes during the PCV13 period vs. pre-PCV period decreased by 95% (Incidence Rate Ratio [IRR] = 0.05; 95% CI = 0.03–0.09). This reduction was observed in a two-step manner: 90% in the PCV7-period and further 5% in the PCV13-period. The rates of IPD caused by the 5 additional PCV13-serotypes (1, 3, 5, 7F, 19A; 5VT) increased initially by 47%, but subsequently decreased by 79%, resulting in an overall 70% reduction during the entire study period (IRR = 0.30; 0.21–0.44). A two-fold increase in non-PCV13 serotypes IPD was observed (IRR = 2.43; 1.73–3.66). In total, a 63% reduction of all-serotype IPD episodes was observed in children <5 years (69% and 48% in children <2 and 2–4 years old, respectively).ConclusionsAfter initiation of PCV NIP, a rapid and substantial 2-step IPD reduction was observed in children <5 years. The serotype-specific rate reduction reflected the sequential introduction of PCV7/PCV13.     

Comparison of the National Surgical Site Infection surveillance data between The Netherlands and Germany: PREZIES versus KISS

As there has been increasing interest in comparing surgical site infection (SSI) rates between countries, we compared the SSI surveillance data for The Netherlands ('PREZIES') and Germany ('KISS'). Both surveillance systems have comparable protocols with many similar risk factors, including SSI definitions developed by the Centers for Disease Control and Prevention and optional postdischarge surveillance. Nine surgical procedure categories from several specialities were included, the reporting of which were similar, with respect to content and with enough data for proper comparison. Differences for the SSI data were found between PREZIES and KISS for duration of surgery, wound contamination class, American Society of Anesthesiologists physical status classification and the postoperative duration of hospitalization. A significantly higher superficial SSI rate was found for seven surgical procedures according to PREZIES and a higher deep SSI rate for five procedures. When considering only deep SSI during hospitalization, the differences in SSI rates were much smaller. Differences in intensity of postdischarge surveillance led to 34% of SSI being detected after discharge for PREZIES and 21% for KISS. In conclusion, even though similar infection surveillance protocols are used in The Netherlands and Germany, differences occurred in the implementation. Comparisons between countries are most reliable if only deep SSIs during hospitalization are taken into account, since these SSI are not affected by postdischarge surveillance and the diagnostic sensitivity for deep SSI is probably more alike between countries than for superficial SSI.