PRAISE: providing a roadmap for automated infection surveillance in Europe.

INTRODUCTION: Healthcare-associated infections (HAI) are among the most common adverse events of medical care. Surveillance of HAI is a key component of successful infection prevention programmes. Conventional surveillance - manual chart review - is resource intensive and limited by concerns regarding interrater reliability. This has led to the development and use of automated surveillance (AS). Many AS systems are the product of in-house development efforts and heterogeneous in their design and methods. With this roadmap, the PRAISE network aims to provide guidance on how to move AS from the research setting to large-scale implementation, and how to ensure the delivery of surveillance data that are uniform and useful for improvement of quality of care. METHODS: The PRAISE network brings together 30 experts from ten European countries. This roadmap is based on the outcome of two workshops, teleconference meetings and review by an independent panel of international experts. RESULTS: This roadmap focuses on the surveillance of HAI within networks of healthcare facilities for the purpose of comparison, prevention and quality improvement initiatives. The roadmap does the following: discusses the selection of surveillance targets, different organizational and methodologic approaches and their advantages, disadvantages and risks; defines key performance requirements of AS systems and suggestions for their design; provides guidance on successful implementation and maintenance; and discusses areas of future research and training requirements for the infection prevention and related disciplines. The roadmap is supported by accompanying documents regarding the governance and information technology aspects of implementing AS. CONCLUSIONS: Large-scale implementation of AS requires guidance and coordination within and across surveillance networks. Transitions to large-scale AS entail redevelopment of surveillance methods and their interpretation, intensive dialogue with stakeholders and the investment of considerable resources. This roadmap can be used to guide future steps towards implementation, including designing solutions for AS and practical guidance checklists.

Validation of an algorithm for semiautomated surveillance to detect deep surgical site infections after primary total hip or knee arthroplasty-A multicenter study.

OBJECTIVE: Surveillance of healthcare-associated infections is often performed by manual chart review. Semiautomated surveillance may substantially reduce workload and subjective data interpretation. We assessed the validity of a previously published algorithm for semiautomated surveillance of deep surgical site infections (SSIs) after total hip arthroplasty (THA) or total knee arthroplasty (TKA) in Dutch hospitals. In addition, we explored the ability of a hospital to automatically select the patients under surveillance. DESIGN: Multicenter retrospective cohort study. METHODS: Hospitals identified patients who underwent THA or TKA either by procedure codes or by conventional surveillance. For these patients, routine care data regarding microbiology results, antibiotics, (re)admissions, and surgeries within 120 days following THA or TKA were extracted from electronic health records. Patient selection was compared with conventional surveillance and patients were retrospectively classified as low or high probability of having developed deep SSI by the algorithm. Sensitivity, positive predictive value (PPV), and workload reduction were calculated and compared to conventional surveillance. RESULTS: Of 9,554 extracted THA and TKA surgeries, 1,175 (12.3%) were revisions, and 8,378 primary surgeries remained for algorithm validation (95 deep SSIs, 1.1%). Sensitivity ranged from 93.6% to 100% and PPV ranged from 55.8% to 72.2%. Workload was reduced by ≥98%. Also, 2 SSIs (2.1%) missed by the algorithm were explained by flaws in data selection. CONCLUSIONS: This algorithm reliably detects patients with a high probability of having developed deep SSI after THA or TKA in Dutch hospitals. Our results provide essential information for successful implementation of semiautomated surveillance for deep SSIs after THA or TKA.

The effect of body mass index on the risk of surgical site infection.

OBJECTIVE: Obesity is considered a risk factor for surgical site infection (SSI). We quantified impact of body mass index (BMI) on the risk of SSI for a variety of surgical procedures. METHODS: We included 2012-2017 data from the Dutch national surveillance network PREZIES on a selection of frequently performed surgical procedures across different specialties. Patients were stratified into 5 categories: underweight (BMI, <18.5 kg/m2), normal weight (BMI, 18.5-25), overweight (BMI, 25-30), obese (BMI, 30-40) and morbidly obese (BMI, ≥40). Multilevel log binomial regression analyses were performed to assess the effect of BMI category on the risk of superficial, deep (including organ-space) and total SSI. RESULTS: Of the 387,919 included patients (ranging from 2,616 for laparoscopic appendectomy to 119,834 for total hip prosthesis), 3,676 (1%) were underweight, 116,778 (30%) had normal weight, 154,339 (40%) were overweight, 104,288 (27%) had obesity, and 8,838 (2%) were morbidly obese. A trend of increasing risk of SSI when BMI increased from normal to morbidly obese was observed for almost all surgery types. The increase was most profound in surgeries with clean wounds, with relative risks for morbidly obese patients ranging up to 7.8 (95% CI, 6.0-10.2) for deep SSI in total hip prosthesis. In chest and abdominal surgeries, the impact was larger for superficial SSI than for deep SSI. CONCLUSIONS: The results of our research provide evidence for the need of preventive programs targeting SSI in overweight and obese patients, as well as for the prevention of obesity in the general population.

Group B Streptococcus in surgical site and non-invasive bacterial infections worldwide: A systematic review and meta-analysis.

OBJECTIVES: The epidemiology of disease caused by group B Streptococcus (GBS; Streptococcus agalactiae) outside pregnancy and the neonatal period is poorly characterized. The aim of this study was to quantify the role of GBS as a cause of surgical site and non-invasive infections at all ages. METHODS: A systematic review (PROSPERO CRD42017068914) and meta-analysis of GBS as a proportion (%) of bacterial isolates from surgical site infection (SSI), skin/soft tissue infection (SSTI), urinary tract infection (UTI), and respiratory tract infection (RTI) was conducted. RESULTS: Seventy-four studies and data sources were included, covering 67 countries. In orthopaedic surgery, GBS accounted for 0.37% (95% confidence interval (CI) 0.08-1.68%), 0.87% (95% CI 0.33-2.28%), and 1.46% (95% CI 0.49-4.29%) of superficial, deep, and organ/space SSI, respectively. GBS played a more significant role as a cause of post-caesarean section SSI, detected in 2.92% (95% CI 1.51-5.55%), 1.93% (95% CI 0.97-3.81%), and 9.69% (95% CI 6.72-13.8%) of superficial, deep, and organ/space SSI. Of the SSTI isolates, 1.89% (95% CI 1.16-3.05%) were GBS. The prevalence of GBS in community and hospital UTI isolates was 1.61% (1.13-2.30%) and 0.73% (0.43-1.23%), respectively. GBS was uncommonly associated with RTI, accounting for 0.35% (95% CI 0.19-0.63%) of community and 0.27% (95% CI 0.15-0.48%) of hospital RTI isolates. CONCLUSIONS: GBS is implicated in a small proportion of surgical site and non-invasive infections, but a substantial proportion of invasive SSI post-caesarean section.

Adhering to a national surgical care bundle reduces the risk of surgical site infections.

BACKGROUND: In 2008, a bundle of care to prevent Surgical Site Infections (SSIs) was introduced in the Netherlands. The bundle consisted of four elements: antibiotic prophylaxis according to local guidelines, no hair removal, normothermia and 'hygiene discipline' in the operating room (i.e. number of door movements). Dutch hospitals were advised to implement the bundle and to measure the outcome. This study's goal was to assess how effective the bundle was in reducing SSI risk. METHODS: Hospitals assessed whether their staff complied with each of the bundle elements and voluntary reported compliance data to the national SSI surveillance network (PREZIES). From PREZIES data, we selected data from 2009 to 2014 relating to 13 types of surgical procedures. We excluded surgeries with missing (non)compliance data, and calculated for each remaining surgery with reported (non)compliance data the level of compliance with the bundle (that is, being compliant with 0, 1, 2, 3, or 4 of the elements). Subsequently, we used this level of compliance to assess the effect of bundle compliance on the SSI risk, using multilevel logistic regression techniques. RESULTS: 217 489 surgeries were included, of which 62 486 surgeries (29%) had complete bundle reporting. Within this group, the SSI risk was significantly lower for surgeries with complete bundle compliance compared to surgeries with lower compliance levels. Odds ratios ranged from 0.63 to 0.86 (risk reduction of 14% to 37%), while a 13% risk reduction was demonstrated for each point increase in compliance-level. Sensitivity analysis indicated that due to analysing reported bundles only, we probably underestimated the total effect of implementing the bundle. CONCLUSIONS: This study demonstrated that adhering to a surgical care bundle significantly reduced the risk of SSIs. Reporting of and compliance with the bundle compliance can, however, still be improved. Therefore an even greater effect might be achieved.

Contribution of Prior, Multiple-, and Repetitive Surgeries to the Risk of Surgical Site Infections in the Netherlands.

OBJECTIVE Surveillance is an important strategy to reduce the incidence of surgical site infections (SSIs). We investigated whether prior, multiple-, or repetitive surgeries are risk factors for SSI and whether they should be preserved in the protocol of the Dutch national SSI surveillance network. METHODS Dutch national SSI surveillance data 2012-2015 were selected, including 34 commonly performed procedures from 8 major surgical specialties. Definitions of SSIs followed international standardized criteria. We used multivariable multilevel logistic regression techniques to evaluate whether prior, multiple-, or repetitive procedure(s) are risk factors for SSIs. We considered surgeries clustered within partnerships of medical specialists and within hospitals (random effects) and different baseline risks between surgical specialties (fixed effects). Several patient and surgical characteristics were considered possible confounders and were included where necessary. We performed analyses for superficial and deep SSIs combined as well as separately. RESULTS In total, 115,943 surgeries were reported by 85 hospitals; among them, 2,960 (2.6%) resulted in SSIs (49.3% deep SSIs). The odds ratio (OR) for having prior surgery was 0.94 (95% confidence interval [CI], 0.74-1.20); the OR for repetitive surgery was 2.39 (95% CI, 2.06-2.77); and the OR for multiple surgeries was1.27 (95% CI, 1.07-1.51). The latter effect was mainly caused by prolonged duration of surgery. CONCLUSIONS Multiple- and repetitive surgeries significantly increased the risk of an SSI, whereas prior surgery did not. Therefore, prior surgery is not an essential data item to include in the national SSI surveillance network. The increased risk of SSIs for multiple surgeries was mainly caused by prolonged duration of surgery, therefore, it may be sufficient to report only duration of surgery to the surveillance network, instead of both (the variables duration of surgery and multiple surgeries). Infect Control Hosp Epidemiol 2017;38:1298-1305.

Cost effectiveness of home ultraviolet B phototherapy for psoriasis: economic evaluation of a randomised controlled trial (PLUTO study).

OBJECTIVE: To assess the costs and cost effectiveness of phototherapy with ultraviolet B light provided at home compared with outpatient ultraviolet B phototherapy for psoriasis. DESIGN: Cost utility, cost effectiveness, and cost minimisation analyses performed alongside a pragmatic randomised clinical trial (the PLUTO study) at the end of phototherapy (mean 17.6 weeks) and at one year after the end of phototherapy (mean 68.4 weeks). SETTING: Secondary care, provided by a dermatologist in the Netherlands. PARTICIPANTS: 196 adults with psoriasis who were clinically eligible for narrowband (TL-01) ultraviolet B phototherapy were recruited from the dermatology departments of 14 hospitals and were followed until the end of phototherapy. From the end of phototherapy onwards, follow-up was continued for an unselected, consecutive group of 105 patients for one year after end of phototherapy. INTERVENTIONS: Ultraviolet B phototherapy provided at home (intervention) and conventional outpatient ultraviolet B phototherapy (control) in a setting reflecting routine practice in the Netherlands. Both treatments used narrowband ultraviolet B lamps (TL-01). MAIN OUTCOME MEASURES: Total costs to society, quality adjusted life years (QALYs) as calculated using utilities measured by the EQ-5D questionnaire, and the number of days with a relevant treatment effect (>/=50% improvement of the baseline self administered psoriasis area and severity index (SAPASI)). RESULTS: Home phototherapy is at least as effective and safe as outpatient phototherapy, therefore allowing cost minimisation analyses (simply comparing costs). The average total costs by the end of phototherapy were euro800 for home treatment and euro752 for outpatient treatment, showing an incremental cost per patient of euro48 (95% CI euro-77 to euro174). The average total costs by one year after the end of phototherapy were euro1272 and euro1148 respectively (difference euro124, 95% CI euro-155 to euro403). Cost utility analyses revealed that patients experienced equal health benefits-that is, a gain of 0.296 versus 0.291 QALY (home v outpatient) by the end of phototherapy (difference 0.0052, -0.0244 to 0.0348) and 1.153 versus 1.126 QALY by one year after the end of phototherapy (difference 0.0267, -0.024 to 0.078). Incremental costs per QALY gained were euro9276 and euro4646 respectively, both amounts well below the normally accepted standard of euro20 000 per QALY. Cost effectiveness analyses indicated that the mean number of days with a relevant treatment effect was 42.4 versus 55.3 by the end of phototherapy (difference -12.9, -23.4 to -2.4). By one year after the end of phototherapy the number of days with a relevant treatment effect were 216.5 and 210.4 respectively (6.1, -41.1 to 53.2), yielding an incremental cost of euro20 per additional day with a relevant treatment effect. CONCLUSIONS: Home ultraviolet B phototherapy for psoriasis is not more expensive than phototherapy in an outpatient setting and proved to be cost effective. As both treatments are at least equally effective and patients express a preference for home treatment, the authors conclude that home phototherapy should be the primary treatment option for patients who are eligible for phototherapy with ultraviolet B light. TRIAL REGISTRATION: Current Controlled Trials ISRCTN83025173 and Clinicaltrials.gov NCT00150930.

Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis: pragmatic multicentre randomised controlled non-inferiority trial (PLUTO study).

OBJECTIVE: To determine whether ultraviolet B phototherapy at home is equally safe and equally effective as ultraviolet B phototherapy in an outpatient setting for patients with psoriasis. DESIGN: Pragmatic multicentre single blind randomised clinical trial (PLUTO study). SETTING: Dermatology departments of 14 hospitals in the Netherlands. PARTICIPANTS: 196 patients with psoriasis who were clinically eligible for narrowband (TL-01) ultraviolet B phototherapy. The first 105 consecutive patients were also followed for one year after therapy. INTERVENTION: Ultraviolet B phototherapy at home using a TL-01 home phototherapy unit compared with standard narrowband ultraviolet B phototherapy in an outpatient setting. Both therapies were done in a setting reflecting routine daily practice in the Netherlands. MAIN OUTCOME MEASURES: The main outcome measure was effectiveness as measured by the proportion of patients with a 50% or more reduction of the baseline psoriasis area and severity index (PASI) or self administered psoriasis area and severity index (SAPASI), called the PASI 50 and SAPASI 50 (relevant treatment effect). Another outcome of effectiveness was the percentage reduction in median scores on the PASI as well as SAPASI. Also the proportions of patients reaching the PASI 75 and SAPASI 75 (successful treatment effect), and the PASI 90 and SAPASI 90 (almost complete clearance) were calculated. Other secondary outcomes were quality of life (SF-36, psoriasis disability index), burden of treatment (questionnaire), patients' preferences and satisfaction (questionnaire), and dosimetry and short term side effects (diary). RESULTS: 82% of the patients treated at home compared with 79% of the patients treated in an outpatient setting reached the SAPASI 50 (difference 2.8%, 95% confidence interval -8.6% to 14.2%), and 70% compared with 73% reached the PASI 50 (-2.3%, -15.7% to 11.1%). For patients treated at home the median SAPASI score decreased 82% (from 6.7 to 1.2) and the median PASI score decreased 74% (from 8.4 to 2.2), compared with 79% (from 7.0 to 1.4) and 70% (from 7.0 to 2.1) for patients treated in an outpatient setting. Treatment effect as defined by the mean decline in PASI and SAPASI scores was significant (P<0.001) and similar across groups (P>0.3). Total cumulative doses of ultraviolet B light were similar (51.5 v 46.1 J/cm(2), difference 5.4, 95% confidence interval -5.2 to 16.0), and the occurrence of short term side effects did not differ. The burden of undergoing ultraviolet B phototherapy was significantly lower for patients treated at home (differences 1.23 to 3.01, all P

UVB phototherapy in an outpatient setting or at home: a pragmatic randomised single-blind trial designed to settle the discussion. The PLUTO study.

BACKGROUND: Home ultraviolet B (UVB) treatment is a much-debated treatment, especially with regard to effectiveness, safety and side effects. However, it is increasingly being prescribed, especially in the Netherlands. Despite ongoing discussions, no randomised research has been performed, and only two studies actually compare two groups of patients. Thus, firm evidence to support or discourage the use of home UVB phototherapy has not yet been obtained. This is the goal of the present study, the PLUTO study (Dutch acronym for "national trial on home UVB phototherapy for psoriasis"). METHODS: We designed a pragmatic randomised single-blind multi-centre trial. This trial is designed to evaluate the impact of home UVB treatment versus UVB phototherapy in a hospital outpatient clinic as to effectiveness, quality of life and cost-effectiveness. In total 196 patients with psoriasis who were clinically eligible for UVB phototherapy were included. Normally 85% of the patients treated with UVB show a relevant clinical response. With a power of 80% and a 0.05 significance level it will be possible to detect a reduction in effectiveness of 15%. Effectiveness will be determined by calculating differences in the Psoriasis Area and Severity Index (PASI) and the Self Administered PASI (SAPASI) scores. Quality of life is measured using several validated generic questionnaires and a disease-specific questionnaire. Other outcome measures include costs, side effects, dosimetry, concomitant use of medication and patient satisfaction. Patients are followed throughout the therapy and for 12 months thereafter. The study is no longer recruiting patients, and is expected to report in 2006. DISCUSSION: In the field of home UVB phototherapy this trial is the first randomised parallel group study. As such, this trial addresses the weaknesses encountered in previous studies. The pragmatic design ensures that the results can be well generalised to the target population. Because, in addition to effectiveness, aspects such as quality of life and cost-effectiveness are also taken into consideration, this study will produce valuable evidence to either support or discourage prescription of home UVB phototherapy. TRIAL REGISTRATION: Current controlled trials/Nederlands Trial register: ISRCTN83025173. Clinicaltrials.gov: NCT00150930.