Standardization in surgery: friend or foe?

The definition of an acceptable standard of healthcare has become more focused by the concepts of personalized medicine with targeted and tailored therapy. Variation in surgical care1–4 and decision-making5 is common. The chances of undergoing surgery may depend as much on where a person lives as on clinical circumstances1,6,7. Some patient choices drive variation (for example by seeking ‘exceptional care’, or the belief thereof) as happens with robotic surgery8, despite lack of documented benefits and even risk of harm9. These circumstances will arise more as patient preferences are expressed and heard (appropriately) in shared decision-making. Meanwhile opponents to standardization consider it diametrically opposed to individualized or patient-centred care10 and a one-size-fits-all, narrow-minded exclusionary attitude. Variation in surgical procedures is not a bad thing but patient outcomes may be unacceptably heterogeneous, especially when delivered beyond the intended use. Unwanted procedures or techniques with inferior outcomes11 drive up healthcare costs12, but cessation may be challenging. As reported in ‘choosing wisely’ campaigns, standardization rarely involves stopping surgical procedures that may be display low value for healthcare systems. The recent moratorium on transanal total mesorectal excision in Norway demonstrates the need to step back and re-evaluate a procedure based on detrimental outcomes13,14. Refinement of patient selection, standardized training, and supervision with evaluation of appropriate outcomes to expected standards are key. This highlights the need for standardization, audit and mature reflection when introducing a new intervention15. Clearly the multicontextual nature of healthcare does not facilitate standardization in every circumstance because patients display biological, psychological, social and cultural diversity. In addition, healthcare professionals have considerably diverse views and perspectives – perhaps defined by the apprenticeship model of training where vertically transmitted approaches to care are ingrained – such that geographical heterogeneity is common. A good example is the approach to managing lateral pelvic sidewall lymph nodes in patients with rectal cancer, where there has been an historical East–West divide. These experiences and tacit knowledge bases constitute ‘mindlines’ as a result of decision maps created by learned behaviour rather than being evidence-based in favour of one or other option. Variation in treatment options is an integral component of individualized care, where several options – each with its inherent benefits and risks – may lead to a good outcome. The risk–benefit is balanced by the surgeon’s aim for the procedure (such as restoration of function or curative intent), the patient’s expectations, and their collective willingness to compromise between risk, benefit and functional consequences. Decisions are sometimes based more on cultural context (for example, routine diverting stoma with an anterior resection) and risk experience (more likely to divert following a recent anastomotic leak) over the reality of clinical knowledge. Ultimately, the decision is best made by an informed patient with clinician involvement with visual aids or internet-based exploration (if needed) at the point of care. Validated comparisons of the different available treatment options, where feasible, should be the goal of standardized care. It is not surprising that agreeing on what standardization means specifically is challenging. The WHO has defined it as ‘the process of developing, agreeing upon and implementing uniform technical specifications, criteria, methods, processes, designs or practices that can increase compatibility, interoperability, safety, repeatability and quality’16. Standardization can be implemented at several levels in healthcare (Table 1), with some examples published recently17,18. Some types of standard may be widespread, whereas others (typically relating to devices) vary considerably and seem to depend on individual surgeon preference19. In theory, most care plans could be standardized within a given institution as standard operating protocols (or procedures), but with some flexibility to encapsulate aberrant disease presentation or variable patient/clinician choices. It is probable that new technologies, smartphones and apps will improve protocol-driven healthcare delivery including perioperative care20. Big data, artificial intelligence and machine learning

The definition of an acceptable standard of healthcare has become more focused by the concepts of personalized medicine with targeted and tailored therapy. Variation in surgical care 1 -4 and decision-making 5 is common. The chances of undergoing surgery may depend as much on where a person lives as on clinical circumstances 1,6,7 . Some patient choices drive variation (for example by seeking 'exceptional care', or the belief thereof) as happens with robotic surgery 8 , despite lack of documented benefits and even risk of harm 9 . These circumstances will arise more as patient preferences are expressed and heard (appropriately) in shared decision-making. Meanwhile opponents to standardization consider it diametrically opposed to individualized or patient-centred care 10 and a one-size-fits-all, narrow-minded exclusionary attitude.
Variation in surgical procedures is not a bad thing but patient outcomes may be unacceptably heterogeneous, especially when delivered beyond the intended use. Unwanted procedures or techniques with inferior outcomes 11 drive up healthcare costs 12 , but cessation may be challenging. As reported in 'choosing wisely' campaigns, standardization rarely involves stopping surgical procedures that may be display low value for healthcare systems. The recent moratorium on transanal total mesorectal excision in Norway demonstrates the need to step back and re-evaluate a procedure based on detrimental outcomes 13,14 . Refinement of patient selection, standardized training, and supervision with evaluation of appropriate outcomes to expected standards are key. This highlights the need for standardization, audit and mature reflection when introducing a new intervention 15 .
Clearly the multicontextual nature of healthcare does not facilitate standardization in every circumstance because patients display biological, psychological, social and cultural diversity. In addition, healthcare professionals have considerably diverse views and perspectives -perhaps defined by the apprenticeship model of training where vertically transmitted approaches to care are ingrained -such that geographical heterogeneity is common. A good example is the approach to managing lateral pelvic sidewall lymph nodes in patients with rectal cancer, where there has been an historical East-West divide. These experiences and tacit knowledge bases constitute 'mindlines' as a result of decision maps created by learned behaviour rather than being evidence-based in favour of one or other option.
Variation in treatment options is an integral component of individualized care, where several options -each with its inherent benefits and risks -may lead to a good outcome. The risk-benefit is balanced by the surgeon's aim for the procedure (such as restoration of function or curative intent), the patient's expectations, and their collective willingness to compromise between risk, benefit and functional consequences. Decisions are sometimes based more on cultural context (for example, routine diverting stoma with an anterior resection) and risk experience (more likely to divert following a recent anastomotic leak) over the reality of clinical knowledge. Ultimately, the decision is best made by an informed patient with clinician involvement with visual aids or internet-based exploration (if needed) at the point of care. Validated comparisons of the different available treatment options, where feasible, should be the goal of standardized care.
It is not surprising that agreeing on what standardization means specifically is challenging. The WHO has defined it as 'the process of developing, agreeing upon and implementing uniform technical specifications, criteria, methods, processes, designs or practices that can increase compatibility, interoperability, safety, repeatability and quality' 16 . Standardization can be implemented at several levels in healthcare (Table 1), with some examples published recently 17,18 . Some types of standard may be widespread, whereas others (typically relating to devices) vary considerably and seem to depend on individual surgeon preference 19 . In theory, most care plans could be standardized within a given institution as standard operating protocols (or procedures), but with some flexibility to encapsulate aberrant disease presentation or variable patient/clinician choices. It is probable that new technologies, smartphones and apps will improve protocol-driven healthcare delivery including perioperative care 20 . Big data, artificial intelligence and machine learning QoL, quality of life; PROM, patient-reported outcome measure. may be incorporated into the concept of tailored care with standard methodology and parameters as a guiding framework for 'individualized standardization' 21 (Fig. 1). The ultimate goal is to merge evidence-based medicine with shared decision-making by using guidelines in conjunction with surgeons' mindlines and patients' wishes.