Applicability of randomized controlled trial evidence on surgery for lumbar disc herniations to clinical reality: a comparison with the nationwide FinSpine registry.
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| Názov: | Applicability of randomized controlled trial evidence on surgery for lumbar disc herniations to clinical reality: a comparison with the nationwide FinSpine registry. |
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| Autori: | Rantalaiho IK; Department of Orthopedics and Traumatology, Turku University Hospital and University of Turku, Turku, Finland. ida.rantalaiho@varha.fi., Pernaa KI; Department of Orthopedics and Traumatology, Turku University Hospital and University of Turku, Turku, Finland., Huttunen JM; Department of Neurosurgery, Kuopio University Hospital, Kuopio, Finland.; Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland., Klimko N; Department of Neurosurgery, Kuopio University Hospital, Kuopio, Finland.; Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland., Salo H; Knowledge Brokers Department, Data and Analytics, Finnish Institute for Health and Welfare, Helsinki, Finland., Malmivaara AV; National Institute for Health and Welfare, Helsinki, Finland.; Orton Orthopaedic Hospital, Helsinki, Finland. |
| Zdroj: | Journal of orthopaedic surgery and research [J Orthop Surg Res] 2025 Nov 04; Vol. 20 (1), pp. 955. Date of Electronic Publication: 2025 Nov 04. |
| Spôsob vydávania: | Journal Article; Comparative Study |
| Jazyk: | English |
| Informácie o časopise: | Publisher: BioMed Central Country of Publication: England NLM ID: 101265112 Publication Model: Electronic Cited Medium: Internet ISSN: 1749-799X (Electronic) Linking ISSN: 1749799X NLM ISO Abbreviation: J Orthop Surg Res Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: London : BioMed Central, 2006- |
| Výrazy zo slovníka MeSH: | Registries*/standards , Randomized Controlled Trials as Topic*/methods , Randomized Controlled Trials as Topic*/standards , Lumbar Vertebrae*/surgery , Intervertebral Disc Displacement*/surgery, Humans ; Treatment Outcome |
| Abstrakt: | Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests. Aims: The evidence of effectiveness of operative treatment of lumbar disc herniation (LDH) is based on findings from RCTs published during the last couple of decades. The applicability of these findings to clinical practise has not previously been evaluated by comparison with nationwide registry data. Our purpose was to assess the clinical homogeneity of the randomised controlled trials, to evaluate the applicability of the findings to the clinical reality utilizing FinSpine registry data and to propose ways to improve the applicability in the future. Methods: A systematic literature search was undertaken to find the RCTs. The benchmarking method compatible with the CONSORT statement was used to document and compare the characteristics of the RCTs and FinSpine registry population. Results: Six RCTs comparing operative treatment of LDH to different methods of conservative treatment showed heterogeneity of patients' clinical characteristics in trial protocols and in actual experiments and a poor adherence to intervention groups. Patient groups were not representative of the catchment area in any of the RCTs. The completeness of documentation of clinically relevant characteristics was limited in all of the RCTs. Despite the deficiencies, the RCT results on operative treatment were comparable with FinSpine registry results. Conclusions: The clinical heterogeneity of the RCTs, non-representative patient populations, incomplete reporting of patient characteristics and poor adherence to treatment groups limit generalizability and applicability of the existing RCTs' results. Our findings mark a need for future pragmatic RCTs as well as clinical registry-based studies to improve the evidence for decision making in real-life settings. (© 2025. The Author(s).) |
| References: | Ann Med. 2015 Jun;47(4):332-40. (PMID: 25965700) Acta Orthop. 2011 Feb;82(1):56-63. (PMID: 21189113) Stem Cells Int. 2012;2012:897183. (PMID: 25098367) N Engl J Med. 2007 May 31;356(22):2245-56. (PMID: 17538084) Spine (Phila Pa 1976). 2006 Oct 1;31(21):2409-14. (PMID: 17023847) J Bone Joint Surg Am. 2004 Apr;86(4):670-9. (PMID: 15069129) JAMA. 2006 Nov 22;296(20):2441-50. (PMID: 17119140) BMJ. 2023 Apr 19;381:e070730. (PMID: 37076169) Spine (Phila Pa 1976). 1983 Mar;8(2):131-40. (PMID: 6857385) J Orthop Surg Res. 2024 Dec 5;19(1):825. (PMID: 39639370) Stem Cells Int. 2012;2012:921053. (PMID: 22550520) Eur Spine J. 2023 Nov;32(11):3731-3743. (PMID: 37718342) Ann Med. 2016 Sep;48(6):440-443. (PMID: 27238631) Curr Stem Cell Res Ther. 2012 Jul;7(4):266-71. (PMID: 22563662) Scand J Med Sci Sports. 2018 Sep;28(9):1970-1981. (PMID: 29770517) N Engl J Med. 2020 Mar 19;382(12):1093-1102. (PMID: 32187469) |
| Grant Information: | A2500/501 Helsingin ja Uudenmaan Sairaanhoitopiiri |
| Entry Date(s): | Date Created: 20251104 Date Completed: 20251105 Latest Revision: 20251108 |
| Update Code: | 20251108 |
| PubMed Central ID: | PMC12584431 |
| DOI: | 10.1186/s13018-025-06401-y |
| PMID: | 41188931 |
| Databáza: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstrakt: | Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.<br />Aims: The evidence of effectiveness of operative treatment of lumbar disc herniation (LDH) is based on findings from RCTs published during the last couple of decades. The applicability of these findings to clinical practise has not previously been evaluated by comparison with nationwide registry data. Our purpose was to assess the clinical homogeneity of the randomised controlled trials, to evaluate the applicability of the findings to the clinical reality utilizing FinSpine registry data and to propose ways to improve the applicability in the future.<br />Methods: A systematic literature search was undertaken to find the RCTs. The benchmarking method compatible with the CONSORT statement was used to document and compare the characteristics of the RCTs and FinSpine registry population.<br />Results: Six RCTs comparing operative treatment of LDH to different methods of conservative treatment showed heterogeneity of patients' clinical characteristics in trial protocols and in actual experiments and a poor adherence to intervention groups. Patient groups were not representative of the catchment area in any of the RCTs. The completeness of documentation of clinically relevant characteristics was limited in all of the RCTs. Despite the deficiencies, the RCT results on operative treatment were comparable with FinSpine registry results.<br />Conclusions: The clinical heterogeneity of the RCTs, non-representative patient populations, incomplete reporting of patient characteristics and poor adherence to treatment groups limit generalizability and applicability of the existing RCTs' results. Our findings mark a need for future pragmatic RCTs as well as clinical registry-based studies to improve the evidence for decision making in real-life settings.<br /> (© 2025. The Author(s).) |
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| ISSN: | 1749-799X |
| DOI: | 10.1186/s13018-025-06401-y |