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 |
Table 45.3.
Factors that can contribute to the development of chronic pain after hernia repair and increase the vulnerability to pain.
Having English as a second language |
Race and ethnicity |
Income and education |
Sex and gender |
Age group
Related posts: Introduction to Primary and Secondary Groin Pain: What Is Inguinodynia?
Prevention of Pain: Optimizing the Laparoscopic TEP and TAPP Techniques
Prophylactic Neurectomy Versus Pragmatic Neurectomy
Patient with Referred Hip Pain
 Chronic Pelvic Pain in Women
 Groin Pain Etiology: Hip-Referred Groin Pain
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