American Society for Enhanced Recovery (ASER) and Perioperative Quality Initiative (POQI) joint consensus statement on measurement to maintain and improve quality of enhanced recovery pathways for elective colorectal surgery

Taxonomy of measures

In order to fully evaluate an ERP, quality measures should include all aspects of the program as categorized according to Donabedian’s Quality of Care Framework: i.e., structure, process, and outcome model (Donabedian 1966). Structure refers to organizational context, both “hard” features (e.g., medical equipment, pharmacy budgets, staffing schedules) and “soft” or cultural factors (i.e., organizational leadership, staffing incentives, team interactions and behaviors). Organizational context may be further divided according to levels of enquiry when conducting evaluations—macro (national or international policy), meso (institutional or regional), or micro (clinical teams). Process refers to the series of actions or steps in the delivery of care. Each of the elements of an ERP is a process that may be measured or recorded. Outcome measures should capture the result of the intervention. Candidate outcomes include patient-reported surveys (e.g., health-related quality of life, satisfaction, quality of recovery), objective and patient-centered measures (e.g., complications, mortality), measures of resource use (e.g., length of hospital or critical care stay), or economic measures (e.g., incremental cost-effectiveness ratio). Measurement of patient factors for the purposes of case-mix adjustment or comparison of baseline characteristics should also be considered.

In the context of a clinical trial of an ERP (or an individual ER element), both process and outcome should be measured. If, as should always be the case with clinical trials of efficacy or effectiveness, there are sufficient resources available to ensure that the treatment (in this case, the pathway) is delivered according to a study protocol, then an “intention-to-treat” analysis may be adopted, with important information derived from measuring protocol deviations to contextualize the outcomes.

In the case of a quality improvement (QI) initiative, process measures are likely to be of most use in driving change, but all three domains of structure, process, and outcome should be evaluated.

Justification for inclusion

ERPs are essentially a series of processes, and compliance with these processes can be used to drive quality improvement initiatives. Compliance with individual processes can be tracked over time (using run charts, e.g., percent use per month) and the nature of observed variation analyzed using statistical process control, to differentiate between common cause, or “natural” variation in the system, or special cause, i.e., unpredictable variation which requires investigation (Peden and Moonesinghe 2016). For example, if preoperative prescription of a gabapentinoid for analgesia is part of your ERP, and use of this medication drops from 90 to 30%, then there may be an explanation for the change in use that needs to be explored further.

Measurement considerations including choice of measures

Recent work in the UK found a modest “dose response” effect between increased compliance with ERP elements and reduced length of hospital stay (Simpson et al. 2015). In keeping with the principles of industrial efficiency, high reliability (>80 or 90% of patients fully compliant) is required to effect improvement in outcomes. Thus, one could argue that external reporting of ER processes, for example, for the purposes of comparison between teams or providers, could be as succinct as simply reporting the binary indicator of whether >80% of patients received all elements of the locally approved ERP. However, by measuring individual elements, particularly those that are more challenging to implement (in UK practice, this has generally been preoperative carbohydrate loading), valuable information can be obtained for quality improvement purposes.

There may be some merit in considering ERPs as care bundles. While most ERPs are not bundles in the traditional sense (as the number of elements within an ERP usually exceeds the recommended three to five) (Resar et al. 2012), there are similarities, which are worthy of note, and raise considerations about how compliance data should be collected. There may be a tendency for clinicians to focus on the individual elements of a pathway or bundle, when contemplating whether implementation may be beneficial to their patients. However, while each element should be evidence based, it is the package, which should be the focus, rather than the individual interventions. The aim should be to implement all elements unless there is a medical contraindication, and take this as the measure of compliance (in bundle terminology—the “all or none” or AON approach) (Borgert et al. 2015).

Two further points require consideration. A recent systematic review of 50 papers relating to colorectal ERPs (Day et al. 2015) found that the level of detail regarding ER processes was generally insufficient to promote knowledge transfer. If a study either reports percentage compliance or uses the “all or none” approach, rather than reporting compliance with individual elements, it remains important that manuscripts provide detail about the pathway’s constituent measures. Finally, clinical experience and published evidence would suggest that some interventions have been straightforward to implement (e.g., in the UK, avoidance of sedative premedication) and others considerably more challenging (e.g., preoperative carbohydrate loading) (Simpson et al. 2015). This observation fits neatly within the Normalization Process Theory—that for a QI intervention to be successful, it should be coherent and encourage cognitive participation, collective action, and reflexive monitoring (May et al. 2009). When a QI intervention is evaluated as having achieved these four aims, it may be deemed to have reached its objective—that is, the process has been fully implemented and thus “normalized”. One may propose, therefore, that if an individual ER element has become so embedded that it is routine, the requirement for formal measurement may have subsided. For example, there would be little value in spending resources on measuring rates of capnography monitoring during surgical anesthesia, as this is a “normalized” process. While normalization is not necessarily irreversible, and thus some vigilance (“reflexive monitoring”) may be required to ensure that pre-implementation practice does not creep back in, omitting unnecessary process measures from data collection may renew clinical focus, enable more cost and clinically effective monitoring and QI, and, ultimately, enable a move more towards the optimal “bundled” approach to implementation.

Recommendations

Risk adjustment

Measurement considerations including choice of measures

Comparison of baseline characteristics to demonstrate the similarities or differences between populations being compared could be as simple as a basic measure of functional status (e.g., the American Society of Anesthesiologists’ Physical Status Score, ASA-PSS), patient age, procedure name, and particularly if long-term outcomes are being compared, patient gender. Such data can provide baseline information without the need for regression analyses required for risk adjustment.

A systematic review of risk prediction/adjustment measures validated in heterogeneous perioperative populations evaluated the literature from 1980 to 2011 and concluded that the Portsmouth-Physiology and Operative Severity Score for the enUmeration of Mortality (P-POSSUM) and the Surgical Risk Scale were the most consistently accurate tools that have been validated in multiple studies; however, both have limitations (Moonesinghe et al. 2013). POSSUM-related tools have been evaluated in a further systematic review in colorectal cancer surgery and, again, P-POSSUM was favored (Richards et al. 2010). An advantage of POSSUM-related tools is their non-proprietary “open source” status—the models are published, enabling any healthcare system which has sufficient resources to collect and analyze their data using this model to adjust risk. However, this openness combined with a fixed model also presents a problem. It is not surprising that a risk model’s accuracy (particularly calibration) will vary over time, as changes in standards of care and the epidemiology of patient health will also change. Therefore, ideally, bespoke models would be developed which can be updated (recalibrated and discrimination re-checked) on regular basis. The NSQIP system does this; however, as the model is not published, it is not possible for other healthcare systems to use it, or validate it on their populations, unless a subscription is paid to enter the program. Nevertheless, the dataset is well known and other systems may therefore chose to collect the constituent variables.

Recommendations

Justification for inclusion

Short-term (inpatient) postoperative complications may have substantial impact on longer-term survival (Khuri et al. 2005; Moonesinghe et al. 2014) and quality of life (Pinto et al. 2016). They also carry substantial cost to the healthcare system (Eappen et al. 2013; Healy et al. 2016).

Measurement considerations including choice of measures

Complications may be measured individually (e.g., pneumonia) or as composite measures (e.g., Clavien-Dindo grading (Clavien et al. 1992; Clavien and Strasberg 2009) or the Postoperative Morbidity Survey (Clavien and Strasberg 2009)). A recent systematic review of colorectal ERPs (Day et al. 2015) found that morbidity was the most commonly measured outcome (98%), followed by length of stay (94%) and mortality (90%).

Even in studies where individual organ-specific complications are recorded (e.g., any study within the NSQIP or Veterans’ Affairs (VA) systems), unless a particular organ-specific outcome is of particular interest (e.g., respiratory outcomes in studies of ventilator-associated pneumonia bundles), many studies report composites of “all complications” or “major complications” (Abedi et al. 2009; Acott et al. 2009; Al-Refaie et al. 2010; Bush et al. 2009; Hamel et al. 2005).

Recommendations

Justification for inclusion

The importance of understanding outcome from the patient perspective to be able to ascertain quality and value of healthcare is acknowledged by patients, providers, and funders.

Modern therapies, particularly those administered on the critical care unit, mean that many patients who may not previously have survived a complicated postoperative course may now leave hospital, sometimes after prolonged stay (beyond 30 days); survivors are also at risk of longer-term sequelae, both physical (Khuri et al. 2005; Moonesinghe et al. 2014; Toner and Hamilton 2013) and psychological (Wade et al. 2012; Wade et al. 2013; Wade et al. 2014; Wade et al. 2015). Thus, short-term survival, while an important metric, does not provide a comprehensive assessment of outcome, particularly from the patient perspective. Therefore, a measure of quality of life or functional status should ideally be administered to help contextualize survival/mortality.

Measurement considerations including choice of measures

Measures that are completed by patients rather than staff may include patient satisfaction, patient experience, quality of recovery, or patient-reported outcomes. Patient experience measures have been developed in different healthcare systems to meet the particular needs of those patient populations and organizational interests; they measure the patients’ views on the whole service experience, including staff behaviors, efficiency of transit through the hospital, and quality of care. Patient satisfaction measures with anesthesia care have been systematically reviewed and their development and validity formally assessed—a list of recommendations for different settings was produced (Barnett et al. 2013). Such measures may be particularly important in the very short term (e.g., within 24 h of surgery, or even before discharge from the recovery ward).

Patient-reported outcomes may be assessed in the short term (for example, the first few days or weeks following surgery) using quality of recovery scores. These measure patients’ symptoms and deviation from usual basic activities such as mobilization and sleeping. Australian researchers have developed a series of quality of recovery scores (Myles et al. 1999; Myles et al. 2000; Stark et al. 2013; Royse et al. 2010) that have been validated and systematically reviewed (Gornall et al. 2013).

Finally, patient-reported outcome measures (PROMs) evaluate health-related quality of life before and after an intervention, and the difference is taken as a measure of the success (or otherwise) of the procedure. The post-procedure measurement is typically recorded 6 months or 1 year after surgery, both generic (e.g., the EQ-5D) and condition/procedure-specific PROMs have been developed and validated. The EQ-5D is a five-domain measure that includes questions for patients about pain, mood, mobility, ability to self-care, and ability to undertake their usual activities. The EQ-5D may also be used in health economic evaluations (see later). The interpretation of health-related quality of life (HRQOL) questionnaires may be subject to some selection bias (completion rates for follow-up questionnaires vary with patient age, socio-demographic status, and ethnicity); nevertheless, they are valid composite measures of outcome and societal cost effectiveness.

The World Health Organization’s Disability Assessment Schedule v2.0 (WHODAS 2.0) has recently been validated in a heterogeneous sample of perioperative patients, of whom approximately a third had “general” surgery (Shulman et al. 2015). The WHODAS was found to be valid and acceptable to patients; it covers both physical and emotional domains in more detail than the EQ-5D. It has yet to be validated in other surgical settings.

Recommendations

Justification for inclusion

Health economic measures are an essential component of a comprehensive outcome framework if the delivery of healthcare is to be efficient in relation to the resources allocated to it. Health economics is “the science that studies human behavior as a relationship between ends and scarce means that have alternative uses” within the context of healthcare (Robbins 1932). One aim of such study is to quantify value, defined as achieving the best possible benefit per unit cost, in order to drive the efficient use of the limited financial resources supporting a healthcare system, whatever the overall system of financial flows within that system. There is an important distinction between price, a transactional concept dependent on an agreed exchange of money between a customer and a provider, and value, which is defined by the customers’ perception of benefit. A variety of definitions of value may be used to characterize the relationship between costs and benefits, but in the healthcare setting, all are limited by the difficulty of attributing a monetary value to a health benefit. Several approaches have been adopted to describe value in healthcare including cost-effectiveness analysis, cost utility analysis, and incremental cost-effectiveness ratios (ICERs). A more detailed introduction to these methods is available elsewhere in the perioperative literature (Grocott and Mythen 2015). In the US setting, the recent change from fee-for-service reimbursement to “bundled payments” has been driven by a desire to constrain healthcare expenditure and improve value.

Measurement considerations including choice of measures

Length of stay (LOS) is one the most commonly used measures in studies of ERPs, due to face validity and ease of measurement; further, reducing length of stay (and therefore by implication complications, and as a result costs) has traditionally been one of the key perceived benefits of ERPs. However, there remain limitations in measurement of LOS: variation in how length of stay is measured may impact comparisons, LOS may be affected by factors other than quality of perioperative care (e.g., occupational therapy or social issues), and as a surrogate for a true economic analysis of costs, it performs poorly, as there is usually a decrement in non-fixed costs as a patient recovers but remains in hospital. When analyzing length of stay data for a population, the data are likely to be skewed by a few long-stay patients. Therefore, while median LOS may be the most statistically appropriate population estimate and the most representative of what most patient’s experience, mean LOS should also be reported, in order to provide a fuller picture of the total costs associated with a service.

The number of postoperative days alive and out of hospital within a limited time frame (e.g., 60 days), colloquially known as “happy days”, is a measure that combines both length of stay (important as a surrogate of complications) and survival. A patient who died in hospital on day 2 postoperatively and a patient who had a complicated postoperative course and a 75-day LOS would both have zero happy days. Such measures avoid the misleading recording of an early postoperative death as a short length of stay.

Quality of life measures are discussed in more detail above. Health economic evaluations commonly incorporate the notion of “quality-adjusted life years” (QALYs) where 1 QALY is a year in perfect health: QALY discounts survival based on quality of life measured using measures such as EQ-5D. A key consideration for health economic analyses is the time frame over which such measures are made. Benefits of surgery may be manifest for many years after the operation and the durability of QoL improvements will have a significant impact on the cost-effectiveness evaluation if a QALY-based analysis is used.

Hospital costs assess the monetary cost of ERPs and rise with increased length of stay and complicated postoperative courses. In a bundled payment environment, costs will be balanced against provider reimbursements to calculate healthcare facility profits or losses (Healy et al. 2016; Dimick et al. 2004). A variety of methods may be used to account for costs within a healthcare institution but the general trend has been towards activity-based costing (ABC), an approach which aims to attribute the true costs of any activity to that activity (including direct costs and indirect costs or overheads). Patient-level costing is specific healthcare example of ABC that has long been used in multi-payer healthcare systems (e.g., the USA) but only relatively recently adopted in “single-payer” nationally funded systems (e.g., NHS in England). ABC offers the potential for international comparisons of the cost effectiveness of healthcare at a patient or institutional level, but unfortunately, such analyses are currently challenging in the absence of internationally agreed standards for ABC.

Recommendations