Surveillance Bias in Outcomes Reporting

Haut, Elliott R.; Pronovost, Peter J.

doi:10.1001/jama.2011.822

Cited by 234 publications

(182 citation statements)

References 11 publications

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“…After excluding the first year of observation, our data demonstrated that patients with Comprehensive surveillance for cancer during that period may have led to a detection bias. 22 However, after excluding the cancer cases that occurred during the first year in our cohort, an increased cancer risk was still observed for patients with cholecystitis. With more than 5 years of followup, the risk remained increased too.…”

Section: Specific Cancer Typesmentioning

confidence: 71%

Risk of Cancer in Patients with Cholecystitis: A Nationwide Population-based Study

Lee

et al. 2015

The American Journal of Medicine

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Section: Specific Cancer Typesmentioning

confidence: 71%

Risk of Cancer in Patients with Cholecystitis: A Nationwide Population-based Study

Lee

et al. 2015

The American Journal of Medicine

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“…This indicates that traditional quality indicators in these institutions (such as BSI or CLABSI rates) are likely to be biased and in fact might not be suitable as quality indicators. There is a danger that mandatory and public reporting of these established quality indicators for health care-associated infections will serve as an incentive for reduced blood culture sampling rates and will finally result in an underreporting of BSI rates ("no screening, no health care-associated infections, no punishment") (15,16). This problem has recently been recognized and has led to a debate about the potential of surveillance bias associated with mandatory reporting of health care-associated infections (17)(18)(19).…”

Section: Discussionmentioning

confidence: 99%

Proposing an Empirically Justified Reference Threshold for Blood Culture Sampling Rates in Intensive Care Units

et al. 2015

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Early and appropriate blood culture sampling is recommended as a standard of care for patients with suspected bloodstream infections (BSI) but is rarely taken into account when quality indicators for BSI are evaluated. To date, sampling of about 100 to 200 blood culture sets per 1,000 patient-days is recommended as the target range for blood culture rates. However, the empirical basis of this recommendation is not clear. The aim of the current study was to analyze the association between blood culture rates and observed BSI rates and to derive a reference threshold for blood culture rates in intensive care units (ICUs). This study is based on data from 223 ICUs taking part in the German hospital infection surveillance system. We applied locally weighted regression and segmented Poisson regression to assess the association between blood culture rates and BSI rates. Below 80 to 90 blood culture sets per 1,000 patient-days, observed BSI rates increased with increasing blood culture rates, while there was no further increase above this threshold. Segmented Poisson regression located the threshold at 87 (95% confidence interval, 54 to 120) blood culture sets per 1,000 patient-days. Only one-third of the investigated ICUs displayed blood culture rates above this threshold. We provided empirical justification for a blood culture target threshold in ICUs. In the majority of the studied ICUs, blood culture sampling rates were below this threshold. This suggests that a substantial fraction of BSI cases might remain undetected; reporting observed BSI rates as a quality indicator without sufficiently high blood culture rates might be misleading. With an incidence of 100/100,000 patient-days at risk and with a case fatality rate of 20 to 50%, bloodstream infections (BSI) are a major cause of morbidity and mortality worldwide (1, 2). Identification of the causal pathogen allows a targeted and shortened antibiotic treatment and is thereby associated with reduced case fatality rates (3, 4) and a lower risk for development of antibiotic resistance (5). Thus, blood culture sampling is the most important diagnostic test for bloodstream infections, as it is the only tool that gives reliable information about the causative pathogen and its resistance profile (6). Knowledge about blood culture sampling rates, however, is also important for the interpretation of quality indicators for nosocomial infections, as those quality indicators (e.g., primary BSI rates) give valid estimates only if a sufficient number of blood cultures is taken. Nevertheless, this is only rarely taken into account when primary BSI rates are reported and interpreted.Recommendations for target blood culture rates have been published in microbiological guidelines. In the United States, the Cumitech guideline recommends 103 to 188 blood culture sets per 1,000 patient-days, referring to a web-based U.S. forum in 1999 (7). However, the relevant discussion in this forum is no longer available and could not be reconstructed by the facilitators of the forum. The German ...

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“…This tight assessment can result in patient responses that differ from those attainable in routine clinical practice. Indeed, each extra visit potentially increases the patient's response to therapy [106,107].…”

Section: Real Life Studies: Limitationsmentioning

confidence: 99%

Randomized controlled trials and real life studies. Approaches and methodologies: a clinical point of view.

Saturni¹,

Bellini²,

Braido³

et al. 2014

Pulmonary Pharmacology & Therapeutics

202

155

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a b s t r a c tRandomized Controlled Trials (RCTs) are the "gold standard" for evaluating treatment outcomes providing information on treatments "efficacy". They are designed to test a therapeutic hypothesis under optimal setting in the absence of confounding factors. For this reason they have high internal validity. The strict and controlled conditions in which they are conducted, leads to low generalizability because they are performed in conditions very different from real life usual care. Conversely, real life studies inform on the "effectiveness" of a treatment, that is, the measure of the extent to which an intervention does what is intended to do in routine circumstances. At variance to RCTs, real life trials have high generalizability, but low internal validity. Recently the number of real life studies has been rapidly growing in different areas of respiratory medicine, particularly in asthma and COPD. The role of such studies is becoming a hot topic in respiratory medicine, attracting research interest and debate.In the first part of this review we discuss some of the advantages and disadvantages of different types of RCTs and analyze the strengths and weaknesses of real life trials, considering the recent examples of some studies conducted in COPD. We then discuss methodological approaches and options to overcome some of the limitations of real life studies.Comparing the conclusions of effectiveness and efficacy trials can provide important pieces of information. Indeed, these approaches can result complementary, and they can guide the interpretation of each other results.

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Surveillance Bias in Outcomes Reporting

Cited by 234 publications

References 11 publications

Risk of Cancer in Patients with Cholecystitis: A Nationwide Population-based Study

Risk of Cancer in Patients with Cholecystitis: A Nationwide Population-based Study

Proposing an Empirically Justified Reference Threshold for Blood Culture Sampling Rates in Intensive Care Units

Randomized controlled trials and real life studies. Approaches and methodologies: a clinical point of view.

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