평가 배경
언어치료는 언어(language) 또는 말(speech)의 이상 진단 시 교정을 위해 언어재활사에 의해 행하여지는 전문작업으로 의사소통을 가능하게 하여 자신을 표현할 수 있고 사회적, 직업적으로 복귀할 수 있도록 도와주는 기술로서, 신의료기술평가제도가 확립되기 전인 2005년 비급여로 등재되었다.
2021년 제7차 의료기술재평가위원회(2021.07.09.)에서는 보건의료 자원의 효율적 사용을 지원하기 위한 근거를 제공하기 위하여, 체계적 문헌고찰을 통해 언어치료의 안전성 및 효과성에 대한 의과학적 근거를 재평가하고, 동 안건에 대하여 권고등급 결정을 수행하는 것으로 심의하였다.
동 안건은 건강보험심사평가원의 행위정의에 따라 ① 뇌졸중, 외상성 뇌손상, 뇌성마비 등의 뇌신경계 질환(이하 ‘뇌신경계 질환’), ② 구음장애, 발성장애, 유창성장애, 실어증, 청각장애로 인한 언어장애(이하 ‘발성장애 등’), ③ 언어발달지연(이하 ‘언어발달지연’), ④ 기타 특수장애로 인한 언어장애 환자(이하 ‘기타 특수장애’)의 4개의 카테고리로 분류하여 평가를 진행하였다. 본 평가에서는 이 중에서 뇌신경계 질환에 대해 평가하였다.
평가 방법
뇌신경계 질환 환자에서 언어치료의 안전성 및 효과성을 재평가하기 위하여 체계적 문헌고찰을 수행하였다. 모든 평가방법은 평가목적을 고려하여 재활의학과 2인, 신경과 1인, 이비인후과 1인, 정신건강의학과 1인, 소아청소년과 1인, 근거기반의학 1인으로 구성된 언어치료 재평가 소위원회(이하 ‘소위원회’)의 심의를 거쳐 확정하였다.
체계적 문헌고찰의 핵심질문은 ‘뇌신경계 질환 환자에서 언어치료는 임상적으로 안전하고 효과적인가?’이다. 본 핵심질문을 토대로 국외 3개, 국내 5개 데이터베이스에서 검색하였으며, 문헌선정 및 배제기준에 따라 두 명의 검토자가 독립적으로 선별하고 선택하였다. 문헌의 비뚤림위험 평가는 Cochrane의 Risk of Bias를 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. 자료합성은 양적 합성이 측정도구 간의 이질성이 높아 불가능할 경우로 판단되어, 질적 검토 방법을 적용하였으며, Grading of Recommendations Assessment, Development and Evaluation (GRADE) 방법을 이용하여 근거 수준을 평가하였다. 2022년 제4차 의료기술재평가위원회(2022.04.15.)에서는 소위원회의 검토 의견을 고려하여 최종 권고등급을 결정하였다.
평가 결과
뇌신경계 질환 환자에서 언어치료의 재평가에 선택된 문헌은 무작위배정 비교임상시험연구 15편이었으며, 뇌졸중 11편, 파킨슨병 4편이었다. 외상성 뇌손상과 뇌성마비 대상으로 선택문헌은 0편이었다.
안전성
뇌신경계 질환 환자에서 언어치료의 안전성은 소위원회의 논의를 바탕으로 치료 관련 부작용 및 이상반응으로 평가하였다. 안전성 결과는 선택문헌 중 4편(뇌졸중 대상 2편, 파킨슨병 대상 2편)에서 안전성에 대해 보고하였으며 언어치료와 관련된 심각한 부작용 및 합병증이 없다고 보고되었다. 그 외 연구에서는 안전성 결과를 보고한 문헌은 없었다. 소위원회는 통상적으로 수행되는 언어치료의 안전성에 문제가 없다는 의견이었다.
효과성
뇌신경계 질환 환자에서 언어치료의 효과성은 소위원회의 논의를 바탕으로 언어 능력, 음성 지표, 심리 지표, 삶의 질로 평가하였다. 소위원회에서는 일차, 이차 결과지표를 명확하게 정의하고 분석을 수행한 연구가 명확하게 정의하지 않은 연구에 비해 상대적으로 질이 높은 것으로 판단하고, 해당 연구에 가중치를 주어 분석하는 것으로 결정하였다. 이에, 뇌졸중 환자를 대상으로 한 문헌 중 단 2편(Breitenstein 등, 2017; Bowen 등, 2012)만이 일차, 이차결과변수의 정의를 명확히 제시하였기 때문에, 선택문헌들 안에서도 상대적으로 질 높은 문헌으로 판단되어 해당 2편의 문헌에 대해서는 별도로 구분하여 기술하기로 결정하였다. 파킨슨병 환자를 대상으로 한 문헌 중에서는 일차, 이차결과변수의 정의를 명확히 제시한 문헌이 없어, 별도의 구분없이 기술하였다.
[뇌졸중]
뇌졸중 환자 대상 문헌 11편 중 9편은 언어치료를 무치료와 비교하였다.
언어능력은 8편에서 보고되었다. 8편 중 일차, 이차결과변수의 정의를 명확히 제시한 문헌은 1편(Breitenstein 등, 2017)이었으며, 일차결과변수인 암스테르담-나이메헌 일상 언어 검사 영역 중 이해가능성(understandability) 영역에서 무치료군에 비해 언어치료군에서 유의한 개선효과를 확인되었다(p=0.0004). 이외 다른 결과지표들은 두 군간 유의한 차이를 보고한 지표와 유의한 차이를 보고하지 않은 지표가 혼재되어 있어 방향이 일관적이지 않았다. 나머지 7편 중 1편에서 무치료군에 비해 언어치료군에서 통계적으로 유의한 개선을 나타냈으며, 3편에서는 각 문헌 당, 보고된 지표들 중 하나의 지표에서만 통계적 유의한 차이를 보고하였고, 이외 보고된 지표들에서는 두 군간 유의한 차이를 보고하지 않았다. 나머지 3편 중 1편에서는 보고된 1개의 효과성 지표 중 2개의 영역(문어 및 명하기)에서만 유의하게 개선된 결과를 보였고 나머지 5개의 영역(반복, 자발적 언어, 구두 이해, 서면 이해, 토큰검사)에서는 두 군간 유의한 차이를 보고하지 않았다. 이외 1편에서는 보고된 지표의 전체점수는 통계적으로 유의한 개선을 보였으나 언어능력 개선을 측정하는 세부영역에서는 통계적으로 유의한 차이를 보이지 않았고, 나머지 1편에서는 언어능력 개선을 측정하는 지표에서 두 군간 유의한 차이를 보이지 않았다. 언어능력을 보고한 연구들의 방향성이 다르고 효과측정시점에 따라서도 그 결과가 일관되지 않았다.
심리상태는 2편에서 보고되었다. 해당문헌들은 일차, 이차결과변수의 정의를 명확히 제시하지 않은 문헌이였다. 1편에서는 무치료군에 비해 언어치료군에서 심리상태가 통계적으로 유의하게 개선되었지만(p=0.000), 다른 1편에서는 두 군간 통계적 유의한 차이를 보이지 않았다.
삶의 질은 1편에서 보고되었다. 해당 문헌은 일차, 이차결과변수의 정의를 명확히 제시한 문헌이였다. Stroke and Aphasia Quality of Life Scale (SAQOL) 지표를 통해 삶의 질을 보고하였으며, 논문 상에서는 해당 지표는 이차결과변수로 보고되었다. 언어치료 전후 삶의 질의 변화가 무치료군에 비해 통계적으로 유의하게 개선된 것으로 보고하였으나(p=0.0365), 삶의 질의 세부영역별로는 군간의 유의한 통계적 차이를 보이지 않았다.
뇌졸중 환자 대상 문헌 11편 중 2편은 언어치료를 active control(사회적 지원 또는 상담)과 비교하였다.
해당 2편 모두 언어능력을 보고하였다. 2편 중 일차, 이차결과변수의 정의를 명확히 제시한 문헌은 1편(Bowen 등, 2012)이었으며, 사회적 지원을 받은 군과의 비교를 수행하였다. 일차결과변수인 Therapy Outcome Measure (TOM) 지표에서 두 군간 유의한 통계적 차이를 보이지 않았으며, 이차결과변수인 Communication Outcomes After Stroke (COAST) 지표에서도 언어치료군과의 유의한 차이가 없는 것으로 나타났다. 나머지 1편에서는 일차, 이차결과변수의 정의를 명확하게 제시하지 않았으며, Porch index of communicative ability (PICA) 지표를 통해 언어능력을 보고하였다, 상담과 비교하였을 때 언어치료군과의 유의한 차이가 없는 것으로 나타났다.
근거수준은 비뚤림위험 평가 및 이질성 등을 고려하여 평가하였으며, ‘매우 낮음’에서 ‘보통’으로 확인되었다.
[파킨슨병]
파킨슨병 환자 대상 문헌 4편은 모두 언어치료를 무치료와 비교하였다.
언어능력은 2편에서 보고되었다. 1편에서는 중재직후 시점에서 무치료군에 비해 언어치료군에서의 언어능력이 개선되었다고 보고하였으며(p=0.003), 다른 1편에서는 1개월 추적관찰시점에서는 언어치료로 언어능력이 유의하게 개선된 효과가 보고되었으나 7개월 시점에서는 언어능력 개선 효과를 확인할 수 없었다.
음성지표는 2편에서 보고되었다. 1편에서는 추적관찰 3개월 시점에서의 발성관련 언어치료의 효과는 확인할 수 없었으나 6개월 시점에서는 효과가 있는 것으로 나타나 언어치료의 효과를 판단할 수 없었으며, National Health Service (NHS) 언어치료의 효과는 추적관찰 3, 6개월 추적관찰시점 모두에서 확인할 수 없었다. 이외 1편의 연구에서는 1, 7개월 추적관찰에서 발성 관련 언어치료의 효과는 있는 반면 조음 관련 언어치료의 효과를 확인할 수 없는 것으로 나타났다.
삶의 질은 2편에서 보고되었다. 1편에서는 3, 6개월 추적관찰시점 모두에서 발성 관련 언어치료의 효과는 확인할 수 없었으며, EuroQoL five-dimensional (EQ-5D)로 측정된 삶의 질 지표에서만 3개월 시점에서 NHS 언어치료의 효과가 있는 것으로 나타났다. Parkinson's Disease Questionnaire (PDQ-39), ICEpop CAPability measure for Older people(ICECAP-O)로 측정된 삶의 질은 3, 6개월 추적관찰 시점 모두에서 NHS 언어치료의 효과를 확인할 수 없었다. 다른 1편에서는 EQ-5D, Voice-Related Quality of Life (V-RQoL), Living with Dysarthria questionnaire (LwD)로 측정된 삶의 질에 대해 언어치료군과 무치료군 간 유의한 차이가 없는 것으로 나타났다.
근거수준은 비뚤림 위험 평가 및 이질성 등을 고려하여 평가하였으며, ‘매우 낮음’에서 ‘낮음’으로 확인되었다.
결론 및 제언
언어치료 재평가 소위원회는 현재 평가 결과에 근거하여 다음과 같이 제언하였다.
뇌신경계 질환 대상으로 언어치료의 안전성은 치료 관련 부작용 및 이상반응에 대한 우려가 낮아 안전한 기술이라고 평가하였다.
뇌신경계 질환 대상으로 언어치료의 효과성은 대상자별로 다음과 같이 평가하였다.
뇌졸중 대상의 언어치료는 무치료와 비교하여 언어치료로 인한 언어능력, 음성지표, 삶의 질 지표의 결과가 일관적이지 않았고, active control과 비교하여 언어치료로 인한 언어능력의 개선이 유의하지 않았다. 이에 소위원회는 평가에 선택된 문헌에서의 뇌졸중 환자의 임상적 특징이 매우 다양하며, 언어치료의 효과를 판단하기에는 평가에 포함된 문헌 대부분의 연구대상자가 소규모인 점을 고려하여 뇌졸중 환자에서 언어치료의 효과에 대한 결론을 내리기 어렵다는 의견이었다. 다만 소위원회에서는 비교적 잘 설계된 한 편의 연구에서 무치료군 대비 언어치료군에서 유의한 언어능력 개선을 확인할 수 있어 언어치료가 도움이 될 수도 있다는 의견을 제시하였다.
파킨슨병 대상의 언어치료는 무치료와 비교하여 언어치료로 인한 언어능력, 음성지표, 삶의 질 지표의 결과가 일관적이지 않고 평가에 선택된 문헌에서의 파킨슨병 환자의 임상적 상황이 매우 다양하며, 언어치료의 효과를 판단하기에는 평가에 포함된 문헌 대부분의 연구대상자가 소규모인 점을 고려하여 파킨슨병 환자에서 언어치료의 효과에 대한 결론을 내리기 어렵다는 것이 소위원회 검토 의견이었다.
외상성 뇌손상 및 뇌성마비 대상의 언어치료는 선택된 문헌이 없어 언어치료의 효과를 판단할 수 없었다.
2022년 제4차 의료기술재평가위원회(2022.04.15.)에서는 소위원회 검토 결과에 근거하여 다음과 같이 심의하였다.
언어치료는 모든 적응증에서 치료 관련 부작용 및 이상반응에 대한 우려가 낮은 안전한 기술로 심의하였다.
뇌졸중 환자에서 언어치료가 언어능력 개선에 도움이 될 수 있다는 현재까지의 문헌적 근거를 고려하여 이에 의료기술재평가위원회는 뇌졸중 환자를 대상으로 언어치료를 ‘조건부 권고함’으로 심의하였다(권고등급: 조건부 권고함)
파킨슨병 환자에서 평가에 포함된 문헌 대부분의 연구대상자가 소규모인 점을 고려하여 언어치료의 효과에 대한 결론을 내리기 어렵다는 의견이었다. 이에 의료기술재평가위원회는 파킨슨병 환자를 대상으로 언어치료를 ‘불충분’으로 심의하였다(권고등급: 불충분).
외상성 뇌손상 및 뇌성마비 환자에서는 선택된 문헌이 없어 언어치료의 효과를 판단할 수 없었다. 이에 의료기술재평가위원회는 외상성 뇌손상 및 뇌성마비 환자를 대상으로 언어치료를 ‘불충분’으로 심의하였다(권고등급: 불충분)
주요어
언어치료, 뇌졸중, 파킨슨병, 안전성, 효과성
Speech and Language Therapy, Stroke, Parkinson disease, Safety, Effectiveness
Background
Speech and Language Therapy (SLT) is a professional service performed by speech-language pathologists for corrective treatment of patients diagnosed with language or speech disorders. The technology provides a treatment for difficulties with communication to enable expression of one’s messages or thoughts as well as support for occupational and social rehabilitation. It was listed as a non-benefit item in 2005 before the New Health Technology Assessment system was established.
At the 7th Health Technology Reassessment Committee (July 09, 2021) in 2021, in order to provide evidence in support of efficient utilization of healthcare resources, medical and scientific evidence for safety and effectiveness of SLT was reassessed through systematic review, and Grade of Recommendation was determined for the technology
According to the definition of reimbursable act by the Health Insurance Review and Assessment Service, health technology reassessment (HTR) was performed based on the four categories as follows: ① cranial nerve diseases such as stroke, traumatic brain injury, and cerebral palsy (hereinafter 'cranial nerve diseases'), ② dysarthria, dysphonia, stuttering, aphasia, and speech disorders due to hearing impairment. (hereinafter 'dysphonia, etc.'), ③ delayed language development (hereinafter 'delayed language development'), and ④ speech disorder patients with other special disabilities (hereinafter 'other special disabilities'). In this report, from the four categories, reassessment was performed for cranial nerve diseases.
Methods
In order to perform reassessment of the safety and effectiveness of SLT in patients with cranial nerve diseases, a systematic review was performed. All assessment methods were finalized after review by the SLT Reassessment Sub-committee (Hereinafter Sub-committee) in consideration of the objectives of the assessment. The Sub-committee consisted of two experts in Rehabilitation Medicine, one in Neurology, one in Otolaryngology, one in Psychiatry, one in Pediatrics and one in Evidence-based Medicine.
The key question of systematic review is “Is Speech and Language Therapy clinically safe and effective in patients with cranial nerve diseases?” In the process of systematic review, based on the key question, three international and five domestic databases were used for literature search and the articles were selected based on independent screening by two reviewers according to the inclusion/exclusion criteria for the related literature. The Cochrane’s Risk of Bias tool was used for assessment of risk of bias (RoB) of the literature and two reviewers independently carried out the assessment to draw a consensus.
For data extraction, a predefined format was used and it was also conducted independently by two reviewers, and in case of disagreement, the two reviewers held discussions with a third party to draw consensus on the matter. For synthesis of data, since quantitative synthesis was considered not possible due to heterogeneity between instruments, qualitative review was performed. The level of evidence for the technology was assessed based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method. At the 4th Health Technology Reassessment Committee (April 15, 2022) in 2022, the final Grade of Recommendation was determined in consideration of the result of the review by the Sub-committee.
Results
The selected literature for the reassessment of SLT in patients with cranial nerve diseases were 15 articles of randomized controlled clinical trials, of which 11 articles were for patients with stroke, and 4 articles for Parkinson's disease (PD). There was no article selected for traumatic brain injury/cerebral palsy
Safety
Safety assessment of SLT in patients with cranial nerve diseases was performed based on the outcomes of treatment-related complications and adverse events, on the basis of the discussion of the Sub-committee. From the selected literature, safety outcomes were reported in 4 articles (4 articles on patients with stroke, 2 articles on patients with PD), and it was reported that there were no serious adverse events/complications related to SLT. Other studies did not report on safety outcomes. The Sub-committee presented a view that there was no problem with the safety in the usual practice of the SLT.
Effectiveness
The effectiveness of SLT in patients with cranial nerve diseases was assessed by language ability, voice parameters, psychological measures, and quality of life based on the discussion of the Sub-committee. The Sub-committee considered that studies that presented clear definitions of primary and secondary outcome measures to perform analysis were of higher quality than those without such definitions, and it was determined that those studies with clear definition of primary and secondary outcome measures were given weights to perform analysis. Accordingly, among articles on stroke patients, only two articles (Breitenstein et al., 2017; Bowen et al., 2012) presented clear definitions of primary and secondary outcome measures, and therefore, these two studies were considered as literature with high-quality research among selected articles. Thus, it was determined that those two articles will be separately discussed and described in the analysis. Among selected literature on patients with PD, there were no articles with clear definitions of primary and secondary outcome measures; thus, it was determined that all of these studies would be described without separate classification.
[Stroke]
Nine out of 11 articles on stroke patients compared the outcomes of SLT intervention with those without intervention (controls).
Language ability was reported in eight articles. Among the eight articles, there was one article (Breitenstein et al., 2017) that clearly presented the definition of primary and secondary outcome measures. Among domains of Amsterdam—Nijmegen Everyday Language Test, which are the primary outcome measures, a significant improvement was confirmed in the SLT group compared to the control group in the domain of understandability (p=0.0004).
As for the other outcome measures, the indicators that reported a significant difference between the two groups and those without such report of a significant difference were described in mixture, and thus, the direction of discussion was not consistent. From the other 7 articles, one article reported a statistically significant improvement in the SLT group than the control group. In three articles, a statistically significant difference was reported in only one outcome measures out of all the reported measures, and no significant difference between the two groups was reported in other indicators reported in these articles. From the remaining 3 articles, 1 article showed a significant improvement in two domains (written language and naming) among one effective metric reported in the article, and no significant inter-group differences were reported in other five domains (repetition, spontaneous speech, oral comprehension, written comprehension, token test). In another article, the total score of the reported outcome measures showed a statistically significant improvement; however, for subdomains for assessment of improvement in language ability, no statistically significant difference was shown. In the other article, no significant inter-group differences were reported in outcome measures for assessment of improvement in the language ability. The direction of the studies that reported the outcomes of language ability was different between studies, and the outcomes were also not consistent depending on the timing of effect measurement.
The psychological well-being of the patients was reported in two articles. These articles did not present clear definitions of primary and secondary outcome measures. In one of the articles, the psychological measure showed a significant improvement in the SLT group compared to the control group (p=0.000), but in the other article, there was no statistically significant difference between the two groups.
Quality of life was reported in one article. This article was the one with a clear presentation on the definition of primary and secondary outcome measures. Quality of life was reported through the Stroke and Aphasia Quality of Life Scale (SAQOL), and in the article, the scale was reported as the secondary outcome measure. The change in quality of life before and after the SLT intervention was reported to show a statistically significant improvement compared to the control group (p=0.0365), but there was no statistically significant difference between the groups by subdomain of quality of life.
Two of the 11 articles on stroke patients compared the outcomes of SLT with those of active controls (social support or counseling).
Both of the two articles reported on the outcome of language ability. Among the two articles, there was one article (Bowen et al., 2012) that clearly presented the definition of primary and secondary outcome measures, and the study compared the outcome measures with those of the group with social support. In the results of Therapy Outcome Measure (TOM), the primary outcome measure, there was no statistically significant difference between the two groups, and likewise, in the results of Communication Outcomes After Stroke (COAST), the secondary outcome measure, there was no significant difference between the SLT group and the social support group. In the other article, there was no clear definition of primary and secondary outcome measures, and outcomes of language ability were reported using Porch Index of Communicative Ability (PICA). When compared with the counselling group, there was no significant difference from the outcomes of the SLT group.
The level of evidence was assessed in consideration of the RoB assessment and heterogeneity, and it was confirmed as from ‘Very Low’ to ‘Moderate.’
[Parkinson’s disease]
All of the 4 articles on patients with PD compared the outcomes of SLT with those of no intervention (controls).
The language ability was reported in 2 articles. In one of the two articles, it was reported that language ability was improved in the SLT group compared to the control group immediately after the intervention (p=0.003). In the other article, language ability was significantly improved in the SLT group compared to the control group at the timepoint of 1-month follow-up, but at 7 months of follow-up, no improvement in language ability was shown.
The voice parameters were reported in 2 articles. In 1 article, the speech-related effect of SLT could not be confirmed at 3 months of follow-up, but the effect was shown at 6 months of follow-up; thus, it was not possible to draw a final conclusion on the effect of SLT. Also, the effect of National Health Service (NHS) SLT was not shown at both 3 months and 6 months of follow-up. In the other article, the speech-related effect of SLT was shown in 1 month and 7 months of follow-up, but the articulation-related effect of SLT was not shown in the follow-up.
Outcomes of quality of life were reported in 2 articles. In one article, the speech-related effect of SLT was not shown at both 3 and 6 months of follow-up. The effect of NHS SLT was shown at 3 months of follow-up only in the quality of life metric assessed by EuroQoL five-dimensional (EQ-5D). On the other hand, the effect of NHS SLT was not shown both at 3 and 6 months of follow-up when the quality of life was measured using Parkinson's Disease Questionnaire (PDQ-39) and ICEpop CAPability measure for Older people(ICECAP-O). In the other article, there was no significant difference between the SLT group and the control group for quality of life measured by EQ-5D, Voice-Related Quality of Life (V-RQoL) and Living with Dysarthria questionnaire (LwD).
The level of evidence was assessed in consideration of the RoB assessment and heterogeneity, and it was confirmed as from ‘Very Low’ to ‘Low.’
Conclusion and Suggestions
The SLT Reassessment Sub-committee suggested the following based on the results of the present assessment
For patients with cranial nerve diseases, SLT was assessed as a safe technology with a low risk of treatment-related complications and adverse events.
For patients with cranial nerve diseases, the effectiveness of SLT was assessed for each type of patient as follows.
SLT for patients with stroke showed inconsistent outcomes in terms of language ability, voice parameters, and quality of life compared to controls, and compared to active controls, improvement in language ability due to intervention of SLT was not significant. Therefore, the Sub-committee presented an opinion as follows: considering that clinical characteristics of the stroke patients in the articles selected for the assessment varied widely and the number of patients in most of the articles included in the assessment was small for final determination on the effect of SLT, it would be difficult to draw a conclusion on the effect of SLT for stroke patients. However, the Sub-committee also presented an opinion that in one study with proper study design, a significant improvement in language ability was confirmed in the SLT group compared to the control group, and therefore, SLT may be helpful for stroke patients.
SLT for patients with PD showed inconsistent outcomes in terms of language ability, voice parameters, and quality of life compared to the control group without intervention, the clinical characteristics of patients with PD in the literature selected for assessment varied widely, and the number of patients in most of the articles included in the assessment was small for determination on the effect of SLT. In consideration of these factors, the Sub-committee presented an opinion that it was difficult to draw a conclusion on the effect of SLT for patients with PD.
Since there was no selected literature on the effect of SLT for patients with traumatic brain injury and cerebral palsy, the effectiveness of SLT could not be determined.
The 4th Health Technology Reassessment Committee (April 15, 2022) in 2022 presented a final review as follows based on the results of the review by the Sub-committee.
SLT was considered a safe technology with a low risk of treatment-related complications and adverse events in all indications.
In consideration of literature evidence published to date that SLT may contribute to the improvement of language ability for patients with stroke, the Health Technology Reassessment Committee determined that the Grade of Recommendation for SLT for stroke patients was ‘Conditional Recommendation’ (Grade of Recommendation: Conditional Recommendation).
For patients with Parkinson’s disease, considering that the number of participants in most of the literature included in the assessment was small, the Sub-committee presented a view that it was difficult to draw a conclusion on the effect of SLT. Accordingly, the Health Technology Reassessment Committee determined that the Grade of Recommendation for SLT for patients with Parkinson’s disease was ‘Insufficient’ (Grade of Recommendation: Insufficient).
Since there was no selected literature on the effect of SLT for patients with traumatic brain injury/cerebral palsy, the effectiveness of SLT could not be determined. Therefore, the Health Technology Reassessment Committee determined that the Grade of Recommendation for SLT for patients with traumatic brain injury/cerebral palsy was ‘Insufficient’ (Grade of Recommendation: Insufficient).
Keywords
SLT, Stroke, Parkinson disease, Safety, Effectiveness
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