Value-Based Clinical Quality Improvement for Chronic Groin Pain After Inguinal Hernia Repair

Traditional clinical research

Value-based clinical quality improvement

Intent

Testing of hypotheses

Improving value

Traditional clinical research

Clinical quality improvement

Pro

Con

Comparison

Pre-market

FDA requirement

Costly and lengthy

Not currently acceptable for pre-market

Human subjects research (potential risk to patient)

Appropriate ethical protections

Costly, limited ability to interpret value

Not ethically appropriate in current environment

Post-market surveillance

Might help determine harmful devices

Costly and lengthy

Appropriate mechanism for post-market surveillance because information is gathered in real time in the real clinical world with no change in patient care

Clinical research

Traditionally known and accepted research mechanism

Costly, rarely answers clinical questions adequately

Ideal for real-world clinical research. Over time, can lead to improved value of care and opportunities to define unmet clinical needs

CQI project

Known research mechanism

Costly, wasteful, may be unethical, limited ability to interpret value

Ideal, as long as it is applied to the whole process of care, or if applied to a subprocess, the outcomes of the whole process are measured concurrently

Off label use/obtain additional indications

May be industry initiated (depending on risks to the patient)

Costly and lengthy

May be appropriate—clinician initiated, no increased risk to patient

Traditional clinical research

Clinical quality improvement

Patient consent

Disclosed to patient that they are participating in a defined clinical research project

Disclosed to patient that CQI is a natural part of their care and that information collected will be used primarily to improve the patient care process for future patients

Methods: Developing a CQI Program for Patients with Chronic Pain After Hernia Repair

Using principles of complex systems science and tools such as CQI programs and nonlinear data analytics (such as predictive analytics), we can define a variety of patient groups who had abdominal wall hernia disease and related complications, such as chronic pain after hernia repair. We have constructed a diverse hernia team to serve the needs of this patient group. Based on feedback from former patients and review of current literature, a dynamic care process is defined for the entire cycle of care, from the moment of first symptom or contact until full return to a maximum quality of life, with ongoing contact for long-term follow-up. One step in the process is to determine the factors involved in producing various outcomes. In reviewing the literature, two sources have produced patient-related factors that contribute to the development of chronic pain after surgery. These factors are listed in Tables 45.2 and 45.3 [11, 12].

Table 45.2.

Preoperative and postoperative factors that can contribute to the development of chronic pain after hernia repair.

Preoperative factors	Postoperative factors
Pain greater than 1 month	Pain
Repeat surgery	Post-op radiation
Psychological vulnerability	Neurotoxic chemotherapy
Anxiety	Depression
Females	Psychological vulnerability
Younger age	Anxiety
Worker’s compensation	Neuroticism
Inefficient diffuse noxious inhibitory control