Critical pathways (CPs) are among the systems used for evaluating and enhancing medical practice through the standardization of medical interventions. The use of CPs is an attempt to increase the satisfaction of patients and medical staff by improving the quality of care and reducing costs by providing appropriate treatment and minimum standard treatment to systematize the treatment of specific diseases [1]. Lumbar disc herniation occurs when the nucleus pulposus within the intervertebral disc, located in the lumbar region, pushes against the annulus fibrosus [2]. In this condition, a part or the entire nucleus pulposus herniates secondary to degenerative changes in the lower lumbar intervertebral disc or rupture of the annulus fibrosus because of external force, inducing neurological symptoms by compressing the dura mater or nerve roots of the spinal cord [3]. Among patients visiting Korean medicine institutions, lumbar disc herniation is a common disease and results in significant medical costs and social losses [4]. The treatment of lumbar disc herniation can be broadly divided into surgical and conservative approaches. The comparative advantage in the treatment efficiency has not been determined. Despite reports of surgery for lumbar disc herniation for over 70 years, the risks of paralysis and side effects remain owing to its invasive nature. Conservative treatment failed in only approximately 5–10% of patients with lumbar disc herniation and thus require surgery, and even after surgical treatment, symptoms do not completely resolve in 10–20% of the patients [5]. In addition, no difference was observed in the recovery rate 4 years after treatment initiation even if varying treatments are employed; thus, standardizing decision-making by medical donors in this environment poses challenges [6]. From the perspective of Korean medicine, lumbar disc herniation is treated through a conservative approach. This includes bed rest, heat therapy, herbal medicine treatment, Chuna therapy, acupuncture therapy, and herbal medicine therapy. Despite its wide adoption in clinical settings, it is reliant on the clinical capabilities of therapists, and the use of standardized CP, which aids decision-makers in making accurate judgments, could not be ascertained. This study analyzed four types of CPs developed in 2021 [7], which were based on the standard clinical practice guidelines (CPGs) of Korean medicine for lumbar disc herniation [8]. The goal was to enhance practical use by applying the developed CPs to integrative medicine hospitals, Korean medicine hospitals, and Korean medicine clinics.

1. Participants

This study enrolled patients diagnosed with lumbar disc herniation regardless of sex, age, and history. The study participants were three integrative medicine hospitals (Kyung Hee University Korean Medicine Hospital, Kyung Hee University Korean Medicine Hospital at Gangdong, and Dong Guk University Bundang Korean Medicine Hospital) and three Korean medicine clinics. For inpatients, the study was conducted from the date of hospitalization to the date of discharge, whereas for outpatients, the study was initiated from the date of admission to the outpatient clinic until the end of treatment.

2. Selection and training

The institutions participating in the study included those offering in-hospital integrative treatment, three integrative medicine hospitals that treat patients with lumbar herniated intervertebral disc (L-HIVD) through inpatient and outpatient services, and three Korean medicine clinics, which were selected as primary medical institutions. Researchers from participating institutions completed the human subject researcher training of the Institutional Review Board (IRB), and the researchers were trained on the study outline, CP application methodology, CP algorithm and treatment plan, actual clinical application protocol, IRB, CP evaluation indicators, and case report form (CRF) data collection via an online orientation.

3. Assessment

Numeral rating scale-axial pain (NRS-axial), numeral rating scale-radiculopathy (NRS-radi), Oswestry disability index (ODI), and Euroqol 5-dimensions 5-levels (EQ-5D-5L) were selected as clinical indicators. The application and completion rates of CPs were prepared for evaluation through the computerization of CP’s electronic medical records (EMRs), and the results were collected electronically concurrently as the pilot application. In the included organizations that did not have a computerized collection system, evaluation was conducted using CRF records. Clinical efficacy was evaluated based on the assessment of the doctor in charge of the study via a fully computerized clinical evaluation template.

4. Data analysis

For data analysis, the researchers used raw data collected from the participants. Microsoft Excel 2016 (Microsoft Corporation) was used for the data analysis.

5. Ethical consideration

In conducting this study, a review of all ethical issues and protection of patient rights was conducted by the IRB of Kyung Hee University Korean Medicine Hospital at Gangdong, which also approved the study protocol (IRB no. KHNMCOH 2020-10-001). The IRB confirmed the need for informed consent. The development phase of a CP tailored to the characteristics of each institution, based on the previously developed CPG, was exempt from review and did not receive a separate research review number. The pilot application study of the developed standard CP of Korean medicine was subjected to an ethical review and was approved by the committee.

6. Critical pathway

A draft CP was created in accordance with the 2021 updated Korean medicine CPGs for lumbar disc herniation [8], and the draft included integrative medicine hospitals, Korean medicine hospitals, Korean medicine clinics, and healthcare institutions according to the type of each medical institution. The draft was finally developed following a review by a consumer group, which involved revising questions and reorganizing categories through a review and consensus process using a modified Delphi method conducted by 17 experts engaged in clinical practice at various institutions. Using the Delphi method, the consensus process and results were reported in an international academic journal [9], and the final CP was produced as CP ver 1.0 in two forms: algorithm and treatment plan.

7. Treatment and theoretical foundations

After a medical professional examines the patient, confirms diagnostic tests and imaging data, and diagnoses the patient with L-HIVD, inpatient or outpatient treatment is determined based on the medical professional’s judgment. Korean medicine treatments include acupuncture, moxibustion, cupping, (bee venom) pharmacoacupuncture, Chuna, thread-embedding acupuncture, and herbal medicine. The L-HIVD CPGs for Korean medicine [8] recommended performing acupuncture and heat application or electrical stimulation or using these methods in conjunction with conventional medical treatments to alleviate symptoms. In addition, treatments such as cupping, moxibustion, and herbal medicine may be performed alone or in combination with other therapies. The treatment algorithm and plan are illustrated in the Figs. 1, 2 and Tables 1–6.

Figure 1. Algorithm for integrative medicine hospitals. L-HIVD, lumbar herniated intervertebral disc; CT, computed tomography; MRI, magnetic resonance imaging; EMG, electromyography; NRS, numeral rating scale; ODI, Oswestry disability index; SF-36, 36-Item Short Form Survey; EQ-5D, Euroqol 5-dimensions; CBC, complete blood test; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; PT&aPTT, prothrombin time & activated partial thromboplastin time; RPR, rapid plasma reagin; HBs Ag, hepatitis B surface antigen; HCV, hepatitis C virus; HIV, human immunodeficiency virus; Hb, hemoglobin; PA, posteroanterior; EKG, electrocardiogram; TENS, transcutaneous electrical nerve stimulation; ABR, absolute bed rest; BR, bed rest; LA, limited ambulation.

Figure 2. Algorithm for Korean medicine clinics. CT, computed tomography; MRI, magnetic resonance imaging; EMG, electromyography; L-HIVD, lumbar herniated intervertebral disc; NRS, numeral rating scale; ODI, Oswestry disability index; SF-36, 36-Item Short Form Survey; EQ-5D, Euroqol 5-dimensions.

Table 1 . Time task matrix: inpatient treatment plan for 4 weeks (for medical staff, integrative medicine hospitals).

Content	Day 1 of admission	Day 2 to week 2	Week 3	Week 4 (discharge)	Caution
Monitoring and observations	▪ Measure BP, pulse, respiration, and temperature every 8 hours	▪ Measure BP, pulse, respiration, and temperature every 8 hours			▪ The differential diagnosis indicates a red flag for back pain, so medical consultation is conducted ▪ If abnormal findings are found in the admission test, follow-up is performed 1–2 times a week ▪ Laboratory test results are explained to the patient immediately ▪ The conversion from inpatient to outpatient care is determined based on the severity of the disease and the results of the clinical evaluation ▪ Guidance on precautions when performing nerve block: no supine position or bathing on the day
	▪ Collect medical history: site, onset, nature, factors, related symptoms, and past medical and treatment history ▪ Perform physical examinations: straight-leg raise test, Lasegue’s test, muscle strength, sensory, and deep tendon reflex tests	-	-	-
Differential diagnosis of red flags	▪ Fractures, cauda equina syndrome, infections, abdominal aortic aneurysm, cancer, etc.	-	-	-
Diagnosis and assessment	▪ NRS-axial, NRS-radi, ODI, EQ-5D, etc.	▪ NRS-axial and NRS-radi: check twice a week ▪ ODI: check once a week ▪ EQ-5D: check upon discharge
	▪ Initial Korean medicine diagnostic methods: pulse and tongue diagnosis	Initial traditional Korean medicine diagnosis methods (pulse and tongue diagnosis): check once a week
Tests	▪ Initial laboratory tests and diagnostic imaging, with additional tests if needed	-	-	Consult for laboratory test the day before discharge
Treatment	▪ Acupuncture, electroacupuncture, herbal medicine, cupping, and moxibustion ▪ Consult with other medical disciplines for pain management (e.g., analgesics and interventions)	▪ Acupuncture (twice a day), electroacupuncture, (bee venom) pharmacoacupuncture, herbal medicine, cupping, moxibustion, infrared treatment, TENS, acupotomy, thread-embedding acupuncture, etc. ▪ Physical therapy (consult with the department of rehabilitation medicine) ▪ Painkiller and nerve block (if necessary)
Diet	▪ General diet (no smoking and drinking alcohol)
Activity	▪ Absolute bed rest/bed rest/limited ambulation ▪ Explain to the patient when changing the order of activities
Education	▪ Explain hospitalization guide and patient safety education (check with the medical staff before taking any medicines brought by the patient) ▪ Explanation of the Korean medicine treatment guide ▪ Description of Korean medicine treatment and prognosis of disease ▪ Explanation of medication guidance and life after treatment (bathing, etc.)	-	▪ Education on lifestyle habits for symptom management ▪ Education on back-strengthening exercises
Others	▪ Personal medicine identification request ▪ Bee venom skin test and patient education	▪ Adjust the dosage of thread-embedding acupuncture, Chuna, and bee venom acupuncture if necessary		▪ Outpatient appointment ▪ Document issuance

BP, blood pressure; -, not available; NRS-axial, numeral rating scale-axial pain; NRS-radi, numeral rating scale-radiculopathy; ODI, Oswestry disability index; EQ-5D, Euroqol 5-dimensions; TENS, transcutaneous electrical nerve stimulation..

Table 2 . Time task matrix: inpatient treatment plan for 4 weeks (for patients, integrative medicine hospitals).

Content	Day 1 of admission	Day 2 to week 2	Week 3	Week 4 (discharge)	Caution
Monitoring and observations	Measure BP, pulse, respiration, and temperature every 8 hours	Measure BP, pulse, respiration, and temperature every 12 hours			▪ The differential diagnosis indicates a red flag for back pain, so medical consultation is conducted ▪ If abnormal findings are found in the admission test, follow-up is performed 1–2 times a week ▪ Bruising may occur at the acupuncture site; it usually disappears within a week ▪ Avoid bathing for approximately 5 hours after acupuncture ▪ Avoid touching the acupuncture site as much as possible ▪ If the treatment site swells or itches after the bee venom acupuncture, please notify the medical staff ▪ The conversion from inpatient to outpatient is determined based on disease severity and the results of the clinical evaluation ▪ Guidance on precautions when performing nerve block: no supine position or bathing on the day
	▪ Collect medical history: site, onset, nature, factors, related symptoms, and past medical and treatment history ▪ Perform physical examinations: straight-leg raise test, Lasegue’s test, muscle strength, sensory, and deep tendon reflex tests	-	-	-
Differential diagnosis of red flags	▪ Fractures, cauda equina syndrome, infections, abdominal aortic aneurysm, cancer, etc.	-	-	-
Diagnosis and assessment	▪ NRS-axial, NRS-radi, ODI, EQ-5D, etc.	▪ NRS-axial and NRS-radi: check twice a week ▪ ODI: check once a week ▪ EQ-5D and SF-36: check upon discharge
	▪ Initial Korean medicine diagnostic methods: pulse and tongue diagnosis	▪ Initial Korean medicine diagnosis methods (pulse and tongue diagnosis): check once a week
Tests	▪ Initial laboratory tests and diagnostic imaging, with additional tests if needed	-	-	▪ Consult for laboratory test the day before discharge
Treatment	▪ Acupuncture, electroacupuncture, herbal medicine, cupping, and moxibustion ▪ Consult with other medical disciplines for pain management (e.g., analgesics and interventions)	▪ Acupuncture (twice a day), electroacupuncture, (bee venom) pharmacoacupuncture, herbal medicine, cupping, moxibustion, infrared treatment, TENS, autotomy, thread-embedding acupuncture, etc. ▪ Physical therapy (consult with department of rehabilitation medicine) ▪ Painkiller and nerve block (if necessary)
Diet	▪ General diet (no smoking and drinking alcohol)
Activity	▪ Absolute bed rest/bed rest/limited ambulation ▪ Explain to the patient when changing the order of activities
Education	▪ Explain the hospitalization guide and patient safety education (check with the medical staff before taking any medicines brought by the patient) ▪ Explanation of the Korean medicine treatment guide ▪ Description of the Korean medicine treatment and prognosis of disease ▪ Explanation of medication guidance and life after treatment (bathing, etc.)	-	▪ Education on lifestyle habits for symptom management ▪ Education on back-strengthening exercises
Others	▪ Personal medicine identification request ▪ Bee venom skin test and patient education	▪ Adjust the dosage of thread-embedding acupuncture, Chuna, and bee venom acupuncture if necessary		▪ Outpatient appointment ▪ Document issuance

BP, blood pressure; -, not available; NRS-axial, numeral rating scale-axial pain; NRS-radi, numeral rating scale-radiculopathy; ODI, Oswestry disability index; EQ-5D, Euroqol 5-dimensions; SF-36, 36-Item Short Form Survey; TENS, transcutaneous electrical nerve stimulation..

Table 3 . Time task matrix: outpatient treatment plan (for medical staff, integrative medicine hospitals).

Content		First	Week 1	Week 2	Week 3	Week 4 to remission	Caution
Monitoring and observation	▪ Measure blood pressure and pulse	O	-	-	-	-	▪ The differential diagnosis indicates a red flag for back pain, so medical consultation is conducted ▪ The number of outpatient treatments and the end of treatment are determined based on the severity and clinical evaluation of the disease ▪ Depending on the clinical progress, admission may be required ▪ When receiving outpatient treatment, make an appointment for the next visit
	▪ Collect medical history: site, onset, nature, factors, related symptoms, and past medical and treatment history	O	-	-	-	-
	▪ Perform physical examinations: straight-leg raise test, Lasegue’s test, muscle strength, sensory, and deep tendon reflex tests	O	-	-	-	-
Differential diagnosis of red flags	▪ Fractures, cauda equina syndrome, infections, abdominal aortic aneurysm, cancer, etc. (evaluation of the need for integrative medicine treatment)	O	-	-	-	-
Diagnosis and assessment	▪ NRS-axial, NRS-radi, ODI, EQ-5D, etc.	O	NRS, once a week; ODI, once every 2 weeks; EQ-5D, once every 4 weeks, at the end
	▪ Initial Korean medicine diagnostic methods: pulse and tongue diagnosis	O	Once a week
Tests	▪ Laboratory tests and diagnostic imaging, if needed	O	Consult for additional tests, if needed
Treatment	Mild
	Acupuncture, electroacupuncture, (bee venom) pharmacoacupuncture, herbal medicine, cupping, moxibustion, infrared treatment, acupotomy, thread-embedding acupuncture, etc.	O (Selective)	O (Selective)	O (Selective)	O (Selective)	O (Selective)
	Moderate
	Acupuncture, electroacupuncture, (bee venom) pharmacoacupuncture, herbal medicine, cupping, moxibustion, infrared treatment, acupotomy, thread-embedding acupuncture, etc.	O (Selective)	O (Selective)	O (Selective)	O (Selective)	O (Selective)
	Integrative medicine treatment (physical therapy, nerve block, etc.)	As required	As required	As required	As required	As required
Education	Explanation of Korean medicine treatment and prognosis of disease	O	-	-	-	-
	Explanation of medication guidance and life after treatment (bathing, etc.)	O	-	-	-	-
	Education on lifestyle habits for symptom management	O	-	-	-	O
	Education on back-strengthening exercises	O	-	-	-	O
Others	Bee venom skin test and patient education	O (Before the first bee venom pharmacoacupuncture)

-, not available; NRS-axial, numeral rating scale-axial pain; NRS-radi, numeral rating scale-radiculopathy; ODI, Oswestry disability index; EQ-5D, Euroqol 5-dimensions..

Table 4 . Time task matrix: outpatient treatment plan (for patients, integrative medicine hospitals).

Content		First	Week 1	Week 2	Week 3	Week 4 to remission	Caution
Monitoring and observation	▪ Measure blood pressure and pulse	O	-	-	-	-	▪ Bruising may occur at the acupuncture site; it usually disappears within a week ▪ Avoid bathing for approximately 5 hours after acupuncture ▪ Avoid touching the acupuncture site as much as possible ▪ If the treatment site swells or itches after the bee venom acupuncture, please notify the medical staff ▪ The number of outpatient treatments and the end of treatment are determined based on the severity and clinical evaluation of the disease ▪ Depending on the clinical progress, admission may be required ▪ When receiving outpatient treatment, make an appointment for the next visit
	▪ Collect medical history: site, onset, nature, factors, related symptoms, and past medical and treatment history	O	-	-	-	-
	▪ Perform physical examinations: straight-leg raise test, Lasegue’s test, muscle strength, sensory, and deep tendon reflex tests	O	-	-	-	-
Differential diagnosis of red flags	▪ Fractures, cauda equina syndrome, infections, abdominal aortic aneurysm, cancer, etc. (evaluation of the need for integrative medicine treatment)	O	-	-	-	-
Diagnosis and assessment	▪ NRS-axial, NRS-radi, ODI, EQ-5D, etc.	O	▪ Once a week
	▪ Initial Korean medicine diagnostic methods: pulse and tongue diagnosis	O	▪ Once a week
Tests	▪ Laboratory tests and diagnostic imaging, if needed	O	▪ Consult for additional tests, if needed
Treatment	Mild
	Acupuncture, electroacupuncture, (bee venom) pharmacoacupuncture, herbal medicine, cupping, moxibustion, infrared treatment, acupotomy, thread-embedding acupuncture, etc.	O (Selective)	O (Selective)	O (Selective)	O (Selective)	O (Selective)
	Moderate
	Acupuncture, electroacupuncture, (bee venom) pharmacoacupuncture, herbal medicine, cupping, moxibustion, infrared treatment, acupotomy, thread-embedding acupuncture, etc.	O (Selective)	O (Selective)	O (Selective)	O (Selective)	O (Selective)
	Integrative medicine treatment (physical therapy, nerve block, etc.)	As required	As required	As required	As required	As required
Education	Explanation of Korean medicine treatment and prognosis of disease	O	-	-	-	-
	Explanation of medication guidance and life after treatment (bathing, etc.)	O	-	-	-	-
	Education on lifestyle habits for symptom management	O	-	-	-	O
	Education on back-strengthening exercises	O	-	-	-	O
Others	Bee venom skin test and patient education	O (Before the first bee venom pharmacoacupuncture)

-, not available; NRS-axial, numeral rating scale-axial pain; NRS-radi, numeral rating scale-radiculopathy; ODI, Oswestry disability index; EQ-5D, Euroqol 5-dimensions..

Table 5 . Time task matrix: outpatient treatment plan (for medical staff, Korean medicine clinics).

Content		First	Week 1	Week 2	Week 3	Week 4 to remission	Caution
Monitoring and observation	▪ Measure blood pressure and pulse	O	-	-	-	-	▪ The differential diagnosis indicates a red flag for back pain and transfer to another medical institution ▪ The number of outpatient treatments and the end of treatment are determined based on the severity and clinical evaluation of the disease ▪ Depending on the clinical progress, admission may be required ▪ When receiving outpatient treatment, make an appointment for the next visit ▪ At the first visit, explain that symptoms may worsen despite treatment and that transfer to another medical institution may be necessary depending on the clinical course
	▪ Collect medical history: site, onset, nature, factors, related symptoms, and past medical and treatment history	O	-	-	-	-
	▪ Perform physical examinations: straight-leg raise test, Lasegue’s test, muscle strength, sensory, and deep tendon reflex tests	O	-	-	-	-
Differential diagnosis of red flags	▪ Fractures, cauda equina syndrome, infections, abdominal aortic aneurysm, cancer, etc. (evaluation of the need for integrative medicine treatment)	O	-	-	-	-
Diagnosis and assessment	▪ NRS-axial, NRS-radi, ODI, EQ-5D, etc.	O	Once a week
	▪ Initial Korean medicine diagnostic methods: pulse and tongue diagnosis	O	Once a week
Tests	▪ Laboratory tests and diagnostic imaging, if needed	O	Consult for additional tests, if needed
Treatment	Single
	Acupuncture, electroacupuncture, (bee venom) pharmacoacupuncture, herbal medicine, cupping, moxibustion, infrared treatment, acupotomy, thread-embedding acupuncture, etc.	▪ Depending on the symptoms, perform single treatment ▪ The intensity of treatment, such as the number of visits or the end of treatment, is determined through a severity assessment
	Complex
	Acupuncture, electroacupuncture, (bee venom) pharmacoacupuncture, herbal medicine, cupping, moxibustion, infrared treatment, acupotomy, thread-embedding acupuncture, etc.	▪ Depending on the symptoms, perform complex treatment ▪ The intensity of treatment, such as the number of visits or the end of treatment, is determined through a severity assessment
Education	Explanation of the Korean medicine treatment and prognosis of disease	O	-	-	-	-
	Explanation of medication guidance and life after treatment (bathing, etc.)	O	-	-	-	-
	Education on lifestyle habits for symptom management	O	-	-	-	O
	Education on back-strengthening exercises	O	-	-	-	O
Others	Bee venom skin test and patient education	O (Before the first bee venom pharmacoacupuncture)

-, not available; NRS-axial, numeral rating scale-axial pain; NRS-radi, numeral rating scale-radiculopathy; ODI, Oswestry disability index; EQ-5D, Euroqol 5-dimensions..

Table 6 . Time task matrix: outpatient treatment plan (for patients, Korean medicine clinics).

Content		First	Week 1	Week 2	Week 3	Week 4 to remission	Caution
Monitoring and observation	▪ Measure blood pressure and pulse	O	-	-	-	-	▪ Bruising may occur at the acupuncture site; it usually disappears within a week ▪ Avoid bathing for approximately 5 hours after acupuncture ▪ Avoid touching the acupuncture site as much as possible ▪ If the treatment site swells or itches after bee venom acupuncture, please notify the medical staff ▪ The number of outpatient treatments and the end of treatment are determined based on the severity and clinical evaluation of the disease ▪ Depending on the clinical progress, admission may be required ▪ When receiving outpatient treatment, make an appointment for the next visit
	▪ Collect medical history: site, onset, nature, factors, related symptoms, and past medical and treatment history	O	-	-	-	-
	▪ Perform physical examinations: straight-leg raise test, Lasegue’s test, muscle strength, sensory, and deep tendon reflex tests	O	-	-	-	-
Differential diagnosis of red flags	▪ Fractures, cauda equina syndrome, infections, abdominal aortic aneurysm, cancer, etc. (evaluation of the need for integrative medicine treatment)	O	-	-	-	-
Diagnosis and assessment	▪ NRS-axial, NRS-radi, ODI, EQ-5D, etc.	O	Once a week
	▪ Initial Korean medicine diagnostic methods: pulse and tongue diagnosis	O	Once a week
Tests	▪ Laboratory tests and diagnostic imaging, if needed	O	Consult for additional tests, if needed
Treatment	Single
	Acupuncture, electroacupuncture, (bee venom) pharmacoacupuncture, herbal medicine, cupping, moxibustion, infrared treatment, acupotomy, thread-embedding acupuncture, etc.	▪ Depending on the symptoms, perform single therapy ▪ The intensity of treatment, such as the number of visits or the end of treatment, is determined through a severity assessment
	Complex
	Acupuncture, electroacupuncture, (bee venom) pharmacoacupuncture, herbal medicine, cupping, moxibustion, infrared treatment, acupotomy, thread-embedding acupuncture, etc.	▪ Depending on the symptoms, perform complex therapy ▪ The intensity of treatment, such as the number of visits or the end of treatment, is determined through a severity assessment
Education	Explanation of the Korean medicine treatment and prognosis of disease	O	-	-	-	-
	Explanation of medication guidance and life after treatment (bathing, etc.)	O	-	-	-	-
	Education on lifestyle habits for symptom management	O	-	-	-	O
	Education on back-strengthening exercises	O	-	-	-	O
Others	Bee venom skin test and patient education	O (Before the first bee venom pharmacoacupuncture)

-, not available; NRS-axial, numeral rating scale-axial pain; NRS-radi, numeral rating scale-radiculopathy; ODI, Oswestry disability index; EQ-5D, Euroqol 5-dimensions..

1. Analysis

CP application, completion, and efficacy were analyzed based on data collected until November 30, 2021. The CP application and completion rates for all patients subjected to CP application at each institution were analyzed. To analyze CP application efficacy, the baseline statistics for each major indicator for all patients in whom CP was applied were stratified into the CP application completed group or uncompleted group. Furthermore, the utility of CP was analyzed by dividing the major baseline statistics by hospital/clinic level and inpatient/ outpatient into the CP application completed and uncompleted groups. The number of patients eligible for each Korean medicine institution and the proportion of CP application/completed group are demonstrated in Tables 7, 8.

Table 7 . Final status for each institution.

Institution		Patient
Integrative medicine hospital	Hospital 1	19
	Hospital 2	20
	Hospital 3	32
Korean medicine clinics	Clinic 1	5
	Clinic 2	6
	Clinic 3	2

Data are presented as number..

Table 8 . Critical pathway application rate and completion rate analysis.

Institution		Entire patient (n)	Applied (n)	Completed (n)	Application rate (%)	Completion rate (%)
Integrative medicine hospital	Entire	289	71	35	24.56747	49.3
	Inpatient	81	25	13	30.86420	52.0
	Outpatient	208	46	22	22.11538	47.8
Korean medicine clinics	Outpatient	58	13	5	22.41379	38.5

2. Disease code analysis

After extracting the most frequent diseases of patients visiting integrative medicine hospitals and Korean medicine clinics for the treatment of lumbar disc herniation, the top eight diseases were selected, and their suitability was evaluated. The selected disease codes were M511 (lumbar and other intervertebral disc disorders with radiculopathy [G55.1*]), M512 (other specified intervertebral disc displacement), M519 (intervertebral disc disorder, unspecified), M5450 (low back pain, multiple sites in spine), M5417 (radiculopathy, lumbosacral region), M4806 (spinal stenosis, lumbar region), S3350 (sprain and strain of the lumbar spine), and S3351 (sprain and strain of lumbosacral [joint, ligament]). The suitability survey for the above disease codes revealed an average value of 58 out of 60, and M519 had the highest suitability average (mean, 9.8). The search used the Korean Standard Classification of Diseases code on the International Classification of Diseases code.

3. Effectiveness analysis

1) All patients

All patients were divided into the CP completed and uncompleted groups, and the effectiveness of CP application was analyzed by comparing clinical index (NRS- axial, NRS-radi, ODI, and EQ-5D-5L) values before and after the CP application. (1) In NRS-axial, no significant decline was observed in both the completed and uncompleted groups. (2) In NRS-radi, a significant decrease was noted in the completed group; however, only a partially significant decrease was noted in the uncompleted group. (3) In ODI items, a significant decline was observed in both the completed and uncompleted groups. (4) In EQ-5D-5L items, a significant decrease was noted in the completed group; however, no significant decrease was observed in the uncompleted group (Table 9).

Table 9 . CP effectiveness analysis (all patients).

Clinical index	CP completed group (n = 31)				CP uncompleted group (n = 35)
	Before application	After application	p-value		Before application	After application	p-value
NRS-axial	6.45 ± 4.79	2.95 ± 2.74	1.17270		6.96 ± 2.56	4.89 ± 3.52	2.51340
NRS-radi	4.23 ± 7.85	2.06 ± 4.26	0.00050*		4.21 ± 9.34	3.23 ± 8.42	0.08540
ODI	49.57 ± 260.77	32.92 ± 215.62	0.00004*		48.80 ± 365.39	36.50 ± 110.30	0.00077*
EQ-5D-5L	12.00 ± 8.80	9.14 ± 10.14	0.04049*		11.14 ± 10.48	9.71 ± 8.57	0.20172

Data are presented as mean ± standard deviation..

CP, critical pathway; NRS-axial, numeral rating scale-axial pain; NRS-radi, numeral rating scale-radiculopathy; ODI, Oswestry disability index; EQ-5D, Euroqol 5-dimensions..

*p < 0.05..

2) Medical environment

Depending on the medical environment, the inpatients and outpatients of integrative medicine hospitals and outpatients of integrative medicine hospitals and Korean medicine clinics were divided into the CP completed/uncompleted groups, and the efficacy of the CP application was analyzed by comparing the clinical index values before and after the CP application. In the overall integrative medicine hospital inpatients and outpatients, no significant decrease was observed in the (1) NRS-axial item in the completed group; however, a significant decrease was noted in the uncompleted group. (2) In the NRS-radi item, a significant decrease was observed in the completed group; however, no significant decrease was noted in the uncompleted group. (3) In the ODI items, a significant decrease was observed in both the completed and uncompleted groups (Table 10).

Table 10 . CP effectiveness analysis (integrative medicine hospital, inpatients and outpatients).

Clinical index	CP completed group (n = 26)				CP uncompleted group (n = 20)
	Before application	After application	p-value		Before application	After application	p-value
NRS-axial	6.46 ± 4.82	2.90 ± 2.68	1.66898		6.73 ± 3.25	4.60 ± 3.62	0.00042*
NRS-radi	3.81 ± 7.92	1.88 ± 4.51	0.00391*		4.08 ± 9.22	3.05 ± 8.05	0.13846
ODI	50.62 ± 291.88	33.97 ± 215.99	0.00022*		48.50 ± 340.68	36.87 ± 105.37	0.00990*
EQ-5D-5L	11.0 ± 2.0	9.5 ± 4.5	0.24645		11.4 ± 12.3	9.2 ± 11.7	0.17235

Data are presented as mean ± standard deviation..

CP, critical pathway; NRS-axial, numeral rating scale-axial pain; NRS-radi, numeral rating scale-radiculopathy; ODI, Oswestry disability index; EQ-5D, Euroqol 5-dimensions..

*p < 0.05..

In all outpatients of the integrative medicine hospital and Korean medicine clinic, no significant decrease was observed in the (1) NRS-axial item in the completed group; however, a significant decrease was noted in the uncompleted group. (2) In the NRS-radi item, a significant decrease was noted in the completed group; however, no significant decrease was observed in the uncompleted group. (3) The ODI items demonstrated a significant decrease in both the completed and uncompleted groups. (4) No significant decline was observed in the EQ-5D-5L items in the completed group, which was similar to that in the uncompleted group (Table 11).

Table 11 . CP effectiveness analysis (integrative medicine hospital and Korean medicine clinics, outpatients).

Clinical index	CP completed group (n = 25)				CP uncompleted group (n = 15)
	Before application	After application	p-value		Before application	After application	p-value
NRS-axial	6.60 ± 5.25	2.74 ± 2.65	1.00155		7.27 ± 1.64	5.27 ± 3.35	0.00096*
NRS-radi	4.32 ± 7.31	2.04 ± 4.46	0.00089*		4.40 ± 10.11	3.47 ± 9.41	0.21011
ODI	46.84 ± 198.64	30.18 ± 178.30	0.00004*		49.22 ± 424.71	36.00 ± 124.41	0.01997*
EQ-5D-5L	12.4 ± 11.3	9.0 ± 14.0	0.08456		10.5 ± 12.5	11.0 ± 0.0	0.43717

Data are presented as mean ± standard deviation..

CP, critical pathway; NRS-axial, numeral rating scale-axial pain; NRS-radi, numeral rating scale-radiculopathy; ODI, Oswestry disability index; EQ-5D, Euroqol 5-dimensions..

*p < 0.05..

3) Medical institutions

Integrative medicine hospital inpatients, integrative medicine hospitals outpatients, and Korean medicine clinic outpatients by the type of institution were divided into the CP completed and uncompleted groups, and the efficacy of CP application was analyzed by comparing clinical index values before and after the CP application. In integrative medicine hospital inpatients, a significant decrease was noted in the (1) NRS-axial item in the completed group; however, no significant decline was observed in the uncompleted group. (2) In NRS-radi items, no significant decrease was noted in both the completed and uncompleted groups. (3) In ODI items, a partially significant decline was found in the completed group; however, no significant decrease was observed in the uncompleted group. (4) In EQ-5D-5L, no significant decrease was noted in both the completed and uncompleted groups (Table 12).

Table 12 . CP effectiveness analysis (integrative medicine hospital, inpatients).

Clinical index	CP complete group (n = 6)				CP incomplete group (n = 7)
	Before application	After application	p-value		Before application	After application	p-value*
NRS-axial	5.83 ± 2.97	3.83 ± 2.57	0.03196*		5.79 ± 4.99	3.86 ± 3.81	0.05552
NRS-radi	3.83 ± 11.77	2.17 ± 4.17	0.16818		4.36 ± 9.23	3.29 ± 8.24	0.25522
ODI	60.97 ± 417.80	44.44 ± 240.84	0.07455		39.24 ± 230.22	34.47 ± 108.50	0.25373
EQ-5D-5L	11.0 ± 2.0	9.5 ± 4.5	0.24645		11.4 ± 12.3	9.2 ± 11.7	0.17235

Data are presented as mean ± standard deviation..

CP, critical pathway; NRS-axial, numeral rating scale-axial pain; NRS-radi, numeral rating scale-radiculopathy; ODI, Oswestry disability index; EQ-5D, Euroqol 5-dimensions..

*p < 0.05..

In integrative medicine hospital outpatients, (1) in the analysis of NRS-axial items, no significant decrease was noted in the completed group; however, a significant decline was observed in the uncompleted group. (2) In NRS-radi items, a significant decrease was noted in the completed group; however, no significant decline was found in the uncompleted group. (3) In ODI items, a significant decrease was noted in both the completed and uncompleted groups (Table 13).

Table 13 . CP effectiveness analysis (integrative medicine hospital, outpatients).

Clinical index	CP completed group (n = 20)				CP uncompleted group (n = 13)
	Before application	After application	p-value		Before application	After application	p-value
NRS-axial	6.65 ± 5.40	2.63 ± 2.50	1.46485		7.23 ± 1.86	5.00 ± 3.33	0.00094*
NRS-radi	3.80 ± 7.33	1.80 ± 4.80	0.00725*		3.92 ± 9.91	2.92 ± 8.58	0.20499
ODI	47.51 ± 230.10	30.83 ± 175.80	0.00035*		53.48 ± 347.38	38.16 ± 107.43	0.00898*

Data are presented as mean ± standard deviation..

CP, critical pathway; NRS-axial, numeral rating scale-axial pain; NRS-radi, numeral rating scale-radiculopathy; ODI, Oswestry disability index..

*p < 0.05..

In Korean medicine clinic outpatients, a significant decrease was noted in the (1) NRS-axial item in the completed group; however, no significant decrease was observed in the uncompleted group. (2) In NRS-radi items, a significant decrease was noted in the completed group; however, no significant decrease was observed in the uncompleted group. (3) In ODI items, a partially significant decrease was noted in the completed group; however, the increase was not significant in the incomplete group. In EQ-5D-5L, a partially significant decline was observed in the completed group; however, the increase was not significant in the uncompleted group (Table 14).

Table 14 . CP effectiveness analysis (Korean medicine clinics, outpatients).

Clinical index	CP completes group (n = 5)				CP uncompleted group (n = 2)
	Before application	After application	p-value		Before application	After application	p-value
NRS-axial	6.4 ± 5.8	3.2 ± 3.7	0.02440*		7.5 ± 0.5	7.0 ± 0.0	0.25000
NRS-radi	6.4 ± 2.3	3.0 ± 2.5	0.00422*		7.5 ± 0.5	7.0 ± 0.0	0.25000
ODI	44.14 ± 87.52	27.56 ± 224.09	0.03692*		21.50 ± 4.50	22.00 ± 0.00	0.39758
EQ-5D-5L	12.4 ± 11.3	9.0 ± 14.0	0.08456		10.5 ± 12.5	11.0 ± 0.0	0.43717

Data are presented as mean ± standard deviation..

CP, critical pathway; NRS-axial, numeral rating scale-axial pain; NRS-radi, numeral rating scale-radiculopathy; ODI, Oswestry disability index; EQ-5D, Euroqol 5-dimensions..

*p < 0.05..

The indiscriminate application of CP can lead to negative results when not fully accounting for individual patient variations [10]. However, the use of appropriate CP, which is based on the extensive medical experience of medical staff accumulated over time and supported by numerous literature reviews, enables the delivery of medical services to patients at an optimal cost. This approach decreases the workload of medical staff and lowers the overall cost of hospitalization. Thus, it is anticipated to maximize the efficiency, convenience, and cost of treatment for patients, medical staff, and hospitals and help in the education of residents and students at university hospitals [11].

At integrative medicine hospitals and Korean medicine clinics, the CP application was divided into completed and uncompleted groups and compared into inpatients and outpatients, and the results revealed the scale decreased in the CP completed group. NRS is a widely utilized tool for assessing patients’ subjective pain levels, particularly low back pain. The ODI is used to evaluate the extent of functional disability experienced in daily life due to low back pain. The EQ-5D-5L is a quality-of- life assessment scale that evaluates a patient’s overall well-being through five specific questions. In both inpatient and outpatient settings, significant changes were observed in these scales among the completed and uncompleted groups. This indicates a notable reduction in patients’ pain levels and functional disability, along with a significant improvement in their quality of life. Inpatients had a higher number of treatments than outpatients. Furthermore, during admission, the active management and medical intervention provided by healthcare personnel may have significantly influenced the effectiveness of the CP application, as the rates of medication adherence and treatment compliance were higher among inpatients than among outpatients. In addition, the effect of CP application was substantially influenced by factors such as the psychological stability associated with hospitalization.

Regarding the differences in the effects of CP application by institution, hospitals typically have specialized medical equipment and personnel compared with clinics. Moreover, patients’ psychological stability toward hospitals may also play a significant role.

The utility and effects noted following CP application at each Korean medicine medical institution for lumbar disc herniation are as follows: (1) improving the quality of treatment—medical accidents can be avoided by preventing the omission of treatments, including the duplication of treatment processes. Moreover, the medical costs borne by patients can be reduced. (2) From the patient’s perspective, listening to a systematic explanation could increase their understanding of the treatment process of lumbar disc herniation and increase their participation in treatment, so they can expect rapid recovery. (3) In addition to enhancing treatment compliance, a clear treatment plan was shared, allowing cooperation and efficient communication between professionals. (4) Regarding patient education, in the past, it depended on the clinical experience and knowledge of medical staff; however, a consistent form of education could be provided to patients via CP.

This study has some limitations. (1) Owing to the limited manpower and space of collaborative medical institutions and Korean medicine clinics, CP application is expected to be effective; however, it cannot be widely implemented in certain areas. (2) Given the course of lumbar disc herniation, the length of stay was extended, and many variables served as covariates in evaluating the effect. (3) If improvement activities have not been completed, the pilot application was initially conducted only at two types of medical institutions, which limits the efficacy evaluation. (4) Cost reductions before and after the CP application should be evaluated; however, this was not measured during the pilot application period. (5) An EMR system is essential when employing CPs; however, in Korean medicine clinics, a computerized system is not well established.

In the clinical practice for patients with L-HIVD, to receive optimal medical services, medical personnel and various departments must work efficiently. Accordingly, the significance of this study is ascribed to its systematic analysis of the benefits and limitations of previously developed CPGs and CPs by applying them to numerous Korean medicine institutions.

In the future, the scope of application must be expanded to healthcare institutions and Korean medicine hospitals, rather than merely in collaborative medical institutions and Korean medicine clinics, by increasing the number of institutions subject to CP application. Conducting an extensive clinical application evaluation research is expected to improve the distribution and diffusion of CP, including the quality of CP. The effect of CP application can be maximized for improvement. In addition, further development through continuous quality improvement is desired. If these activities continue, the main contents of the CPGs, which are the basis of CPs, will be easily conveyed to clinical Korean medicine doctors, and quality treatment based on objective evidence will be provided. This process can contribute to the reduction in socioeconomic losses by improving national health and can be used as baseline data for future health policies.

Conceptualization: JHK, YHB, BKS. Funding acquisition: BKS. Investigation: JS, JHK. Formal analysis: JS, JHK. Methodology: BG, YCP, SSN. Writing - original draft: JS. Writing – review & editing: All authors.

The authors have no conflicts of interest to declare.

This research was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: RS-2022-KH127499 & RS-2024-00441695).

This study was a questionnaire survey with human participants. The study was approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital at Gangdong (IRB no. KHNMCOH 2020-10-001). The IRB confirmed the need for informed consent.