Objective

National validation of claims-based surveillance for surgical-site infections (SSIs) following colon surgery and abdominal hysterectomy.

Design

Retrospective cohort study.

Setting

US hospitals selected for data validation by Centers for Medicare & Medicaid Services (CMS).

Participants

The study included 550 hospitals performing colon surgery and 458 hospitals performing abdominal hysterectomy in federal fiscal year 2013.

Methods

We requested 1,200 medical records from hospitals selected for validation as part of the CMS Hospital Inpatient Quality Reporting program. For colon surgery, we sampled 60% with a billing code suggestive of SSI during their index admission and/or readmission within 30 days and 40% who were readmitted without one of these codes. For abdominal hysterectomy, we included all patients with an SSI code during their index admission, all patients readmitted within 30 days, and a sample of those with a prolonged surgical admission (length of stay > 7 days). We calculated sensitivity and positive predictive value for the different groups.

Results

We identified 142 colon-surgery SSIs (46 superficial SSIs and 96 deep and organ-space SSIs) and 127 abdominal-hysterectomy SSIs (58 superficial SSIs and 69 deep and organ-space SSIs). Extrapolating to the full CMS data validation cohort, we estimated an SSI rate of 8.3% for colon surgery and 3.0% for abdominal hysterectomy. Our colon-surgery surveillance codes identified 93% of SSIs, with 1 SSI identified for every 2.6 patients reviewed. Our abdominal-hysterectomy surveillance codes identified 73% of SSIs, with 1 SSI identified for every 1.6 patients reviewed.

Conclusions

Using claims to target record review for SSI validation performed well in a national sample.

Background: Recent efforts to study quality improvement (QI) efforts to improve the effectiveness and efficiency of healthcare have raised important questions about ethical boundaries for waiving informed consent. Confusion exists because similar projects can be undertaken for research or QI purposes, a distinction currently used to define Institutional Review Board oversight. However, patients are not aware of such distinctions. We sought to evaluate patients' views of waiving consent for non-invasive projects to improve healthcare quality and delivery. Methods: We developed a 32-item measure of patient thresholds for waiving consent for different types of QI interventions, including those involving changes to: 1) the hospital environment; 2) hospital policies or procedures; 3) objects used by patients; 4) medications or devices; and 5) use of patient information. In a sample of 200 hospitalized patients, we tested and confirmed the reliability and validity of subscales representing each of the 5 intervention types. Results: For each of the five consent threshold scales, all items in each scale had substantial item-to-total correlations with the other items in that scale taken together. All five internal consistency reliability coefficients exceeded.70 for the total sample. Means for all 5 scales indicated general patient support for waiving consent across all categories of interventions studied. However, patients were significantly less comfortable foregoing consent for interventions involving medications or devices, or sharing of patient information. Conclusion: We developed and tested a survey instrument to contribute to the understanding of patient preferences for consent in QI assessment activities. Measures were found to be reliable and valid. Findings indicated general patient support for waiving consent across all minimal risk categories studied. However, more work is needed to reassure and protect patients during minimal risk studies involving medications or devices, or the sharing of patient information.

Background

Universal skin and nasal decolonisation reduces multidrug-resistant pathogens and bloodstream infections in intensive care units. The effect of universal decolonisation on pathogens and infections in non-critical-care units is unknown. The aim of the ABATE Infection trial was to evaluate the use of chlorhexidine bathing in non-critical-care units, with an intervention similar to one that was found to reduce multidrug-resistant organisms and bacteraemia in intensive care units.

Methods

The ABATE Infection (active bathing to eliminate infection) trial was a cluster-randomised trial of 53 hospitals comparing routine bathing to decolonisation with universal chlorhexidine and targeted nasal mupirocin in non-critical-care units. The trial was done in hospitals affiliated with HCA Healthcare and consisted of a 12-month baseline period from March 1, 2013, to Feb 28, 2014, a 2-month phase-in period from April 1, 2014, to May 31, 2014, and a 21-month intervention period from June 1, 2014, to Feb 29, 2016. Hospitals were randomised and their participating non-critical-care units assigned to either routine care or daily chlorhexidine bathing for all patients plus mupirocin for known methicillin-resistant Staphylococcus aureus (MRSA) carriers. The primary outcome was MRSA or vancomycin-resistant enterococcus clinical cultures attributed to participating units, measured in the unadjusted, intention-to-treat population as the HR for the intervention period versus the baseline period in the decolonisation group versus the HR in the routine care group. Proportional hazards models assessed differences in outcome reductions across groups, accounting for clustering within hospitals. This trial is registered with ClinicalTrials.gov, number NCT02063867.

Findings

There were 189 081 patients in the baseline period and 339 902 patients (156 889 patients in the routine care group and 183 013 patients in the decolonisation group) in the intervention period across 194 non-critical-care units in 53 hospitals. For the primary outcome of unit-attributable MRSA-positive or VRE-positive clinical cultures (figure 2), the HR for the intervention period versus the baseline period was 0·79 (0·73-0·87) in the decolonisation group versus 0·87 (95% CI 0·79-0·95) in the routine care group. No difference was seen in the relative HRs (p=0·17). There were 25 (<1%) adverse events, all involving chlorhexidine, among 183 013 patients in units assigned to chlorhexidine, and none were reported for mupirocin.

Interpretation

Decolonisation with universal chlorhexidine bathing and targeted mupirocin for MRSA carriers did not significantly reduce multidrug-resistant organisms in non-critical-care patients.

Funding

National Institutes of Health.

Importance

Universal nasal mupirocin plus chlorhexidine gluconate (CHG) bathing in intensive care units (ICUs) prevents methicillin-resistant Staphylococcus aureus (MRSA) infections and all-cause bloodstream infections. Antibiotic resistance to mupirocin has raised questions about whether an antiseptic could be advantageous for ICU decolonization.

Objective

To compare the effectiveness of iodophor vs mupirocin for universal ICU nasal decolonization in combination with CHG bathing.

Design, setting, and participants

Two-group noninferiority, pragmatic, cluster-randomized trial conducted in US community hospitals, all of which used mupirocin-CHG for universal decolonization in ICUs at baseline. Adult ICU patients in 137 randomized hospitals during baseline (May 1, 2015-April 30, 2017) and intervention (November 1, 2017-April 30, 2019) were included.

Intervention

Universal decolonization involving switching to iodophor-CHG (intervention) or continuing mupirocin-CHG (baseline).

Main outcomes and measures

ICU-attributable S aureus clinical cultures (primary outcome), MRSA clinical cultures, and all-cause bloodstream infections were evaluated using proportional hazard models to assess differences from baseline to intervention periods between the strategies. Results were also compared with a 2009-2011 trial of mupirocin-CHG vs no decolonization in the same hospital network. The prespecified noninferiority margin for the primary outcome was 10%.

Results

Among the 801 668 admissions in 233 ICUs, the participants' mean (SD) age was 63.4 (17.2) years, 46.3% were female, and the mean (SD) ICU length of stay was 4.8 (4.7) days. Hazard ratios (HRs) for S aureus clinical isolates in the intervention vs baseline periods were 1.17 for iodophor-CHG (raw rate: 5.0 vs 4.3/1000 ICU-attributable days) and 0.99 for mupirocin-CHG (raw rate: 4.1 vs 4.0/1000 ICU-attributable days) (HR difference in differences significantly lower by 18.4% [95% CI, 10.7%-26.6%] for mupirocin-CHG, P < .001). For MRSA clinical cultures, HRs were 1.13 for iodophor-CHG (raw rate: 2.3 vs 2.1/1000 ICU-attributable days) and 0.99 for mupirocin-CHG (raw rate: 2.0 vs 2.0/1000 ICU-attributable days) (HR difference in differences significantly lower by 14.1% [95% CI, 3.7%-25.5%] for mupirocin-CHG, P = .007). For all-pathogen bloodstream infections, HRs were 1.00 (2.7 vs 2.7/1000) for iodophor-CHG and 1.01 (2.6 vs 2.6/1000) for mupirocin-CHG (nonsignificant HR difference in differences, -0.9% [95% CI, -9.0% to 8.0%]; P = .84). Compared with the 2009-2011 trial, the 30-day relative reduction in hazards in the mupirocin-CHG group relative to no decolonization (2009-2011 trial) were as follows: S aureus clinical cultures (current trial: 48.1% [95% CI, 35.6%-60.1%]; 2009-2011 trial: 58.8% [95% CI, 47.5%-70.7%]) and bloodstream infection rates (current trial: 70.4% [95% CI, 62.9%-77.8%]; 2009-2011 trial: 60.1% [95% CI, 49.1%-70.7%]).

Conclusions and relevance

Nasal iodophor antiseptic did not meet criteria to be considered noninferior to nasal mupirocin antibiotic for the outcome of S aureus clinical cultures in adult ICU patients in the context of daily CHG bathing. In addition, the results were consistent with nasal iodophor being inferior to nasal mupirocin.

Trial registration

ClinicalTrials.gov Identifier: NCT03140423.

Background

Detection and containment of hospital outbreaks currently depend on variable and personnel-intensive surveillance methods. Whether automated statistical surveillance for outbreaks of health care-associated pathogens allows earlier containment efforts that would reduce the size of outbreaks is unknown.

Methods

We conducted a cluster-randomized trial in 82 community hospitals within a larger health care system. All hospitals followed an outbreak response protocol when outbreaks were detected by their infection prevention programs. Half of the hospitals additionally used statistical surveillance of microbiology data, which alerted infection prevention programs to outbreaks. Statistical surveillance was also applied to microbiology data from control hospitals without alerting their infection prevention programs. The primary outcome was the number of additional cases occurring after outbreak detection. Analyses assessed differences between the intervention period (July 2019 to January 2022) versus baseline period (February 2017 to January 2019) between randomized groups. A post hoc analysis separately assessed pre-coronavirus disease 2019 (Covid-19) and Covid-19 pandemic intervention periods.

Results

Real-time alerts did not significantly reduce the number of additional outbreak cases (intervention period versus baseline: statistical surveillance relative rate [RR]=1.41, control RR=1.81; difference-in-differences, 0.78; 95% confidence interval [CI], 0.40 to 1.52; P=0.46). Comparing only the prepandemic intervention with baseline periods, the statistical outbreak surveillance group was associated with a 64.1% reduction in additional cases (statistical surveillance RR=0.78, control RR=2.19; difference-in-differences, 0.36; 95% CI, 0.13 to 0.99). There was no similarly observed association between the pandemic versus baseline periods (statistical surveillance RR=1.56, control RR=1.66; difference-in-differences, 0.94; 95% CI, 0.46 to 1.92).

Conclusions

Automated detection of hospital outbreaks using statistical surveillance did not reduce overall outbreak size in the context of an ongoing pandemic. (Funded by the Centers for Disease Control and Prevention; ClinicalTrials.gov number, NCT04053075. Support for HCA Healthcare's participation in the study was provided in kind by HCA.).