평가배경
비밸브재건술은 내, 외비밸브 협착에 의한 코막힘 환자에게 필요시 연골을 삽입하거나 재배치하거나 접거나 당기거나 봉합 또는 연장하여 내, 외비밸브를 넓히는 시술이다. 동 기술은 2014년 제6차 신의료기술평가위원회(2014.07.25.)에서 안전성 및 유효성에 대한 근거가 있는 의료기술로 심의되었으며, 이후 비급여 항목으로 등재되었다(보건복지부고시 제2016-61호(2016.4.27.)).
제5차 의료기술재평가위원회(2020.05.11.~05.13. 서면심의)에서는 보건의료 자원의 효율적 사용을 위한 의사결정에 문헌적 근거를 토대로 한 정보를 제공하기 위하여, 업데이트 체계적 문헌고찰을 통해 비밸브재건술의 임상적 안전성 및 유효성에 대한 의과학적 근거를 재평가하며, 동 안건에 대하여 권고등급 결정을 수행하는 것으로 심의하였다.
평가방법
비밸브재건술의 안전성 및 유효성의 근거를 평가하기 위하여 업데이트 체계적 문헌고찰을 실시하였다. 모든 평가방법은 평가목적을 고려하여 이비인후과 3인, 성형외과 1인, 근거기반의학 1인 등 총 5인으로 구성된 비밸브재건술 재평가 소위원회(이하 소위원회)의 심의를 거쳐 확정하였다.
비밸브재건술 재평가 소위원회는 2020년 7월부터 2020년 10월까지 약 3개월에 걸쳐 총 3회의 소위원회 운영을 통해 문헌적 근거에 따라 동 기술을 평가하고 검토결과를 제출하였다.
2020년 제11차 의료기술재평가위원회(2020.11.13.)에서는 비밸브재건술의 안전성 및 유효성 재평가 결과를 최종 심의하였다.
업데이트 체계적 문헌고찰의 핵심질문은 ‘내ㆍ외비밸브 협착에 의한 코막힘 환자에게 비밸브재건술은 안전하고 유효한가?’이다. 본 핵심질문을 토대로 국외 3개, 국내 5개 데이터베이스에서 검색하였으며, 문헌선정 및 배제기준에 따라 두 명의 검토자가 독립적으로 선별하고 선택하였다. 문헌의 비뚤림위험 평가는 RoBANS ver 2.0를 사용하여 두 명의 검토자가 독립적으로 수행하여 의견합의를 이루었다. 자료추출은 미리 정해놓은 자료추출 양식을 활용하여 두 명의 검토자가 독립적으로 수행하였으며, 의견 불일치가 있을 경우 제3자와 함께 논의하여 합의하였다. 자료분석은 정성적 분석을 적용하였다. 의료기술재평가위원회는 소위원회의 검토 의견을 고려하여 최종 권고등급을 결정하였다.
평가결과
업데이트 체계적 문헌고찰의 최종 선정 문헌 총 9편은 모두 국외에서 수행된 전후연구(전향적 5편, 후향적 4편)였으며, 기 신의료기술평가에 포함된 문헌 18편 중 비밸브 협착으로 인한 코막힘 치료 목적의 대상자 및 비밸브재건술 단독 중재의 조건을 만족하는 11편이 포함되어 본 재평가에서는 총 20편의 문헌이 선정되었다.
안전성
비밸브재건술에 대한 안전성은 소위원회의 논의를 바탕으로 시술 관련 부작용 및 이상반응으로 결과지표로 설정하였으며, 부작용 및 이상반응을 보고한 16편의 문헌을 근거로 평가하였다. 이 중 6편(37.5%)에서 수술 중/후 부작용 및 이상반응이 발생하지 않았다(0%)고 보고하였으며, 발생을 보고한 10편에서 사례별로는 부종 5.8-16.7%, 감염 0.9-25.0%, 통증 7.7-12.5% 등으로 나타났다. 그 외 심각한 합병증 또는 부작용 사례가 보고된 바 없어, 소위원회에서는 안전성은 수용할만한 수준이라는 의견이었다.
유효성
비밸브재건술에 대한 유효성은 소위원회의 논의를 바탕으로 코막힘 개선정도의 객관적 측정지표인 최소 단면적(minimal cross sectional area), 비강기도 저항(nasal airway resistance, NAR) 및 최고흡기기류속도(peak inspiratory flow rate, PIFR)와 주관적 측정지표인 Nasal Obstruction Symptom Evaluation(NOSE), Visual Analogue Scale(VAS), Rhinoplasty Outcomes Evaluation(ROE), Linear Symptom Scale(LSS), 코막힘 재발여부 및 환자 만족도로 평가하였다.
비밸브재건술 전후의 평균 최소 단면적은 4편의 전후연구에서 보고하였는데, 수술 전후의 평균값을 제시한 3편의 연구 모두에서 평균 최소 단면적이 수술 후에 수술 전보다 향상되었으며, 이 중 2편에서 통계적으로 유의한 것으로 나타났다. NAR은 2편의 전후연구에서 보고하였는데, Palesy 등(2015)의 연구에서는 median NAR이 수술 후에 수술 전보다 향상되었지만 통계적으로 유의하지는 않았고, Paniello 등(1996)의 연구에서는 수술 후 큰 개선을 보인 환자가 83.3%(10/12명)이었다. PIFR은 3편의 전후연구에서 보고하였는데, 모든 연구에서 평균 PIFR이 수술 후에 수술 전보다 통계적으로 유의하게 향상되었다.
비밸브재건술 전후의 NOSE 점수는 9편의 전후연구에서 보고하였는데, 모든 연구에서 수술 후에 수술 전보다 통계적으로 유의하게 향상되었다. VAS 점수는 8편의 전후연구에서 보고하였고, 모든 연구에서 수술 후에 수술 전보다 통계적으로 유의하게 개선되었다. ROE 점수는 2편의 전후연구에서 보고하였으며, 모든 연구에서 수술 후에 수술 전보다 통계적으로 유의하게 향상되었다. LSS 점수는 1편의 전후연구에서 보고하였고, 수술 후에 수술 전보다 통계적으로 유의하게 향상되었다. 환자 만족도는 8편의 전후연구에서 보고하였는데, 모든 연구에서 수술 후에 환자 만족도가 우수한 수준인 것으로 나타났다.
소위원회에서는 코막힘의 객관적 지표인 최소 단면적, 비강 흐름과 주관적 지표인 NOSE, VAS, ROE, LSS 지표 및 환자 만족도에서 유의한 향상을 보여 유효한 시술이라는 의견이었다.
결론
비밸브재건술 재평가 소위원회는 현재 평가 결과에 근거하여 다음과 같이 제언하였다.
비밸브재건술은 비밸브 협착에 의한 코막힘 환자를 대상으로 코막힘 증상을 치료하는 데 있어 안전성 및 유효성에 대한 근거가 있는 의료기술이지만, 문헌들의 근거수준이 낮은 제한점이 있다고 평가하였다.
의료기술재평가위원회는 “비밸브재건술”에 대해 소위원회 검토결과에 근거하여 다음과 같이 심의하였다 (2020.11.13.).
의료기술재평가위원회는 내ㆍ외 비밸브 협착에 의한 코막힘 환자를 대상으로 코막힘 증상 치료를 위한 비밸브재건술을 권고한다(권고등급 Ⅰ-b). 권고사유는 다음과 같다.
비밸브재건술은 비밸브 협착에 의한 코막힘 환자를 대상으로 코막힘 증상을 치료하는 데 있어 안전성 및 유효성에 대한 근거가 있는 의료기술이지만, 문헌들의 근거수준이 낮은 제한점이 있다고 평가하였다.
Background
Nasal valve reconstruction is a procedure to widen the internal and external nasal valves by inserting, repositioning, folding, pulling, suturing, or extending cartilage when necessary in patients with nasal obstruction caused by internal or external nasal valve stenosis. This technology was reviewed as a health technology with a basis for safety and effectiveness at the 6th New Health Technology Assessment Committee (2014.07.25.) in 2014, and was subsequently registered as a non-benefit item (Ministry of Health and Welfare Notice No. 2016-61 2016.4.27.).
At the 5th HealthTechnology Reassessment Committee (May 11, 2020, - May 13, 2020, written review), to provide information based on the literature on decision-making for efficient use of health and medical resources, it is deliberated that the medical evidence for the clinical safety and effectiveness of nasal valve reconstruction was reevaluated through updated systematic literature review and the decision was made to determine the grade of recommendation for this case.
Methods
An updated systematic literature review was conducted to evaluate the safety and effectiveness of nasal valve reconstruction. All evaluation methods were finalized after deliberation by the nasal valve reconstruction reassessment subcommittee (hereinafter referred to as the subcommittee), which consisted of a total of 5 members including 3 from the Department of Otolaryngology, 1 from Department of Plastic & Reconstructive Surgery, and 1 from Department of Evidence-based Medicine, in consideration of the research purpose.
The nasal valve reconstruction reassessment subcommittee evaluated the technology based on the literature and submitted the review results through three subcommittees operating for about 3 months from July 2020 to October 2020.
The safety and effectiveness reevaluation results of nasal valve reconstruction were finally reviewed at the 11th Health Technology Reassessment Committee (2020.11.13.) in 2020.
A key question in the updated systematic literature review is 'Is nasal valve reconstruction safe and effective for patients with nasal obstruction due to internal/external nasal valve stenosis?'. Based on this key question, three overseas and five domestic databases were searched, and two reviewers independently screened and selected them according to the literature inclusion and exclusion criteria. The evaluation of the risk of bias in the literature was conducted independently by two reviewers using RoBANS ver 2.0 and consensus was reached. Data extraction was performed independently by two reviewers using a pre-determined data extraction format, and in case of disagreement, it was agreed upon by discussion with a third party. Qualitative analysis was applied for data analysis. The Health Technology Reassessment Committee decided on the final grade of recommendation in consideration of the review opinions of the subcommittee.
Results
A total of 9 pieces of literature finally selected for the updated systematic literature review were all before and after studies (5 prospective, 4 retrospective studies) conducted abroad. A total of 20 articles were selected for this reevaluation, including 11 articles that satisfy the conditions for subjects for the treatment of obstruction and the single intervention of nasal valve reconstruction among 18 articles included in the previous new health technology assessment.
Safety
For the safety of nasal valve reconstruction, treatment-related side effects and adverse events were set as outcome indicators based on the discussion of the subcommittee, and evaluation was made based on 16 literature reports of side effects and adverse events. Among them, it was reported that no side effects or adverse events occurred (0%) during/after surgery in 6 articles (37.5%). In 10 articles that reported the occurrence, edema was 5.8-16.7%, infection 0.9-25.0%, and pain 7.7-12.5%. No other serious complications or side effects were reported, so the subcommittee concluded that the safety was acceptable.
Effectiveness
The effectiveness of nasal valve reconstruction was evaluated by objective measures of improvement in nasal obstruction, such as the minimal cross-sectional area, nasal airway resistance (NAR), and peak inspiratory flow rate (PIFR), and subjective measurement indicators, which are including nasal obstruction symptom evaluation (NOSE), visual analogue scale (VAS), rhinoplasty outcomes evaluation (ROE), linear symptom scale (LSS), recurrence of nasal obstruction and patient satisfaction, based on the discussion of the subcommittee.
The average minimum cross-sectional area before and after nasal valve reconstruction was reported in 4 before and after studies. In all three studies that presented the mean values before and after surgery, the average minimum cross-sectional area was improved after surgery compared to before surgery, and it was found to be statistically significant in two of them. NAR was reported in two before and after studies. In the study of Palesy et al. (2015), median NAR improved after surgery, but it was not statistically significant. In the study of Paniello et al. (1996), 83.3% (10/12 patients) showed significant improvement after surgery. PIFR was reported in 3 before and after studies. In all studies, the mean PIFR was statistically significantly improved after surgery compared to before surgery.
The NOSE score before and after nasal valve reconstruction was reported in 9 before and after studies, and in all studies, it was statistically significantly improved after surgery compared to before surgery. VAS score was reported in 8 before and after studies, and in all studies, it was statistically significantly improved after surgery compared to before surgery. The ROE score was reported in two before and after studies, and in all studies, it was statistically significantly improved after surgery compared to before surgery. The LSS score was reported in one before and after study, and it was statistically significantly improved after surgery compared to before surgery. Patient satisfaction was reported in 8 before and after studies, and all studies showed that the patient satisfaction level after surgery was excellent.
The subcommittee was of the opinion that the procedure was effective as it showed a significant improvement in objective indicators of nasal obstruction, such as minimum cross-sectional area, nasal flow, and in subjective indicators, including NOSE, VAS, ROE, LSS, and patient satisfaction.
Conclusion
The nasal valve reconstruction reassessment subcommittee made the following recommendations based on the current evaluation results.
Although nasal valve reconstruction is a health technology that has evidence for safety and effectiveness in treating nasal obstruction symptoms in patients with nasal obstruction caused by nasal valve stenosis, it was evaluated that there are limitations with the low level of evidence in the literature.
The Health Technology Reassessment Committee deliberated on “nasal valve reconstruction” as follows based on the results of the subcommittee’s review (November 13, 2020).
The Health Technology Reassessment Committee recommends nasal valve reconstruction for the treatment of nasal obstruction symptoms in patients with nasal obstruction caused by internal/external nasal valve stenosis (grade of recommendation I-b). The reasons for the recommendation are as follows.
Although nasal valve reconstruction is a health technology that has evidence for safety and effectiveness in treating nasal obstruction symptoms in patients with nasal obstruction caused by nasal valve stenosis, it was evaluated that there are limitations with the low level of evidence in the literature.
Keywords
Nasal Valve Stenosis, Nasal Valve Insufficiency, Nasal Obstruction, Nasal Valve Reconstruction
연구정보
의료기술재평가보고서
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