“Seek and you shall find” The Bible, Matthew 7:7

Quality and safety improvement initiatives are a burgeoning field of study in medicine. In gastroenterology, most published studies focus on endoscopy [1]. Developing cost-effective, sustainable, and evidence-based strategies to decrease adverse events in endoscopy is only possible if we understand and accurately account for such events [2] [3].

“… there is growing evidence that active systems, such as patient reporting, are necessary to determine the true adverse event rate after endoscopic procedures.”

Colonoscopy remains the most commonly used method of screening for colorectal cancer (CRC) [4], despite other options such as flexible sigmoidoscopy, the fecal occult blood test (FOBT), and Cologuard [5] [6]. Being such a frequent procedure worldwide, understanding and monitoring its adverse event frequency and severity becomes of utmost importance for patient safety, healthcare utilization costs, and value-based purchasing [3]. Multiple studies have been done to assess the frequency of adverse events in different populations, and a number of centers have reported methods to improve the accuracy of reported post-colonoscopy adverse events (PCAEs) [3] [6].

The reported PCAE rate seems to vary significantly depending on how it is captured, being higher when an active reporting strategy is used (i. e. direct contact with all patients after the procedure or a multidisciplinary infrastructure with multiple capture mechanisms) compared with passive reporting (i. e. procedure documentation, rate of emergency room visits, or hospitalization after colonoscopy). Adverse events are also more frequently reported for diagnostic colonoscopies than for screening examinations [2] [7], with rates also being higher with age [7] and with psychiatric disorders [4], and influenced as well by the distance of patient’s home from the hospital, being less frequently reported in those patients who live farther from the index hospital than by their counterparts [8].

A possible alternative to gathering PCAE data in a more automated way would be to use health insurance claims. Stock et al. [9] published a study performed in Germany to assess the incidence of the most common PCAEs compared with a control group that did not undergo the examination. The interesting point here is that health insurance claims data were the only source of information on PCAEs. No other active or passive capturing systems were used. Severe PCAEs were categorized as perforation, bleeding, myocardial infarction, stroke, splenic injury, and other. The incidence of severe PCAEs in the 30 days subsequent to the examination was 0.29 %, a total of 97 adverse events being described in the 33 086 colonoscopies analyzed [9]. This study demonstrated similar findings when compared with other population-based studies [2] [10] [11].

To date, the majority of studies have focused on a passive reporting strategy and have revealed adverse event rates from 0.28 % in the general population undergoing screening examinations [12], up to 2.6 % and 3.4 % in patients older than 65 and 80 years, respectively, undergoing diagnostic examinations [7].

In this issue of Endoscopy, Hoff et al. [13] present a study that shows the incidence of adverse events after colonoscopy in Norway, with both passive and active capture mechanisms for these events. In addition to healthcare personnel documentation during and immediately after colonoscopy, patients undergoing the examination in 21 different centers were given a prepaid envelope with a form to be mailed the day after the procedure. The patient questionnaire inquired about the preparation and the examination, consisting of questions with a rating scale on examination quality and common adverse events, along with free-text fields.

The underestimation of severe adverse events by healthcare providers, with what would be considered a passive reporting mechanism, was highly significant. Fifteen of the 18 patients (83 %) who required hospital admission for a severe adverse event were captured only by the patient forms: a reported incidence increase from 0.03 % to 0.16 %. Further analysis of the colonoscopy reports was unable to find any indicator or predictor of a future complication. Vasovagal reaction without syncope and bleeding were the only events captured more frequently by the medical staff before discharge when compared with the patient reports.

The study makes the point that, without patient-reported feedback, we will fail to document important PCAEs, partly because the majority of severe PCAEs occur after the patient’s discharge from the clinic/hospital [14]. This timing of severe adverse events was also demonstrated following a number of different ambulatory procedures (colonoscopy, upper gastrointestinal endoscopy, ophthalmological procedures etc.) in a study by Fox et al. in 2014 [15]. Immediate post-procedure hospitalization occurred in 0.1 % compared with 3.18 % of patients unexpectedly needing acute care in the 7 days subsequent to the procedure, either visiting the emergency room and/or needing hospitalization. This study highlights the importance of observing adverse events in the days following any ambulatory procedure, including colonoscopies, as ignoring this interval could miss 95 % of such events. This increase in the reporting and capturing of adverse events post-ambulatory procedures was also observed specifically for colonoscopies: while the need for hospitalization occurred in only 0.04 % of patients immediately after the procedure, the data for the 7 subsequent days showed an acute-care need rate of 1.32 %.

The difference between the reported incidence of PCAEs by a passive mechanism, such as the combination of physician self-reported data and medical record information, compared with an active approach, where patient-reported outcomes are added to the established PCAE-capturing mechanisms, has also been seen in other published studies. Adler et al. [16] showed a three-fold increase in reported PCAEs when comparing conventional passive reporting of adverse events (0.15 %) with active reporting by adding questionnaires to both physicians and patients (0.45 %) following screening colonoscopies in Germany. While still using a low-cost method to collect patient-reported adverse events, the current study shows an approximately 10-fold increase in the reporting of adverse events.

Passive reporting is a low-cost way to monitor adverse events but it seems very likely it will be underestimating real events in the United States for multiple reasons, one being the fragmentation of healthcare (i. e. patients using more than one healthcare facility for elective and emergent care) [3] [8]. This alone could account for significant under-reporting, as hypothesized by Jackson et al. [8]. Using private insurance and Medicare claims could be an alternative method to capture more adverse events [3], similar to that used by Hoff et al., with the Norwegian quality assurance network for endoscopy, Gastronet, collecting procedure information reported by the physician as well as patient feedback and patient-reported outcomes.

Direct contact with patients via mail or a telephone call, or combining a passive and active approach, with physicians and nurses also involved in reporting data, documents a higher incidence of adverse events compared with passive reporting [3] [16]. Establishing a program to accurately capture severe adverse events after colonoscopy that is both sustainable and reliable, doesn’t require additional dedicated personnel or resources, and can be standardized and implemented across different centers has remained a challenge in the American healthcare system.

The underestimation of adverse events if patient-reported outcomes are ignored was reiterated by the findings of the current study. Providing clear information to patients on how to proceed when post-procedure symptoms occur should be part of the standardized protocol for colonoscopies.

Capturing PCAEs automatically would be ideal. Nonetheless, despite all the advances in electronic medical records, we have not yet reached that point. One can hope that more cooperation between healthcare facilities and automated feedback provided by insurance claims, both private and government based, could build a reliable and cost-efficient mechanism for capturing PCAEs.

Healthcare delivery will be more and more influenced by value-based purchasing. Implicit in this value is the reduction of adverse events [17]. Without standardized systems to reliably estimate adverse event rates, we cannot reliably demonstrate the value of colonoscopy. Based on the current study and several similar studies, there is growing evidence that active systems, such as patient reporting, are necessary to determine the true adverse event rate after endoscopic procedures. Such efforts, as shown here by Hoff and colleagues, are to be commended and encouraged.

• References

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