Pure intervention effect or effect in routine health care - Blinded or non-blinded randomized controlled trial

BMC Medical Research Methodology

Volumn 18, Issue 1, 2018, Pages

  Malmivaara, Antti ^a,b  

^a NATIONAL PUBLIC HEALTH INSTITUTE   (Finland)

^b ORTON Invalid Foundation   (Finland)

Author keywords

Applicability; Arthroscopic partial meniscectomy; Blinding; Clinical comparability; Cost effectiveness; Effectiveness; Randomized controlled trial; Study question analysis

Indexed keywords

ARTHROSCOPY; COST BENEFIT ANALYSIS; DOUBLE BLIND PROCEDURE; ECONOMICS; HUMAN; KNEE INJURY; KNEE OSTEOARTHRITIS; OUTCOME ASSESSMENT; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); REPRODUCIBILITY; SINGLE BLIND PROCEDURE; STANDARDS; STATISTICS AND NUMERICAL DATA;

ARTHROSCOPY; COST-BENEFIT ANALYSIS; DOUBLE-BLIND METHOD; HUMANS; KNEE INJURIES; OSTEOARTHRITIS, KNEE; OUTCOME ASSESSMENT (HEALTH CARE); RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; SINGLE-BLIND METHOD;

EID: 85052724029     PISSN: None     EISSN: 14712288     Source Type: Journal    
DOI: 10.1186/s12874-018-0549-z     Document Type: Review

References (21)

1. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.
2. Wechsler ME, Kelley JM, Boyd IO, Dutile S, Marigowda G, Kirsch I, Israel E, Kaptchuk TJ. Active albuterol or placebo, sham acupuncture, or no intervention in asthma. N Engl J Med. 2011;365(2):119-26.
3. Veerus P, Fischer K, Hakama M, Hemminki E, EPHT Trial. Results from a blind and a non-blind randomised trial run in parallel: experience from the Estonian postmenopausal hormone therapy (EPHT) trial. BMC Med Res Methodol. 2012;12:44. 2288-12-44
4. Monk P, Garfjeld Roberts P, Palmer AJ, Bayliss L, Mafi R, Beard D, Hopewell S, Price A. The urgent need for evidence in arthroscopic meniscal surgery: a systematic review of the evidence for operative Management of Meniscal Tears. Am J Sports Med. 2017;45(4):965-73.
5. Swart NM, van Oudenaarde K, Reijnierse M, Nelissen RG, Verhaar JA, Bierma-Zeinstra SM, Luijsterburg PA. Effectiveness of exercise therapy for meniscal lesions in adults: a systematic review and meta-analysis. J Sci Med Sport. 2016;19(12):990-8.
6. van de Graaf VA, Wolterbeek N, Mutsaerts EL, Scholtes VA, Saris DB, de Gast A, Poolman RW. Arthroscopic partial meniscectomy or conservative treatment for nonobstructive meniscal tears: a systematic review and meta-analysis of randomized controlled trials. Arthroscopy. 2016;32(9):1855-65. e4
7. Lamplot JD, Brophy RH. The role for arthroscopic partial meniscectomy in knees with degenerative changes: a systematic review. Bone Joint J. 2016;98-B(7):934-8.
8. Thorlund JB, Juhl CB, Roos EM, Lohmander LS. Arthroscopic surgery for degenerative knee: systematic review and meta-analysis of benefits and harms. Br J Sports Med. 2015;49(19):1229-35.
9. Beaufils P, Becker R, Kopf S, Englund M, Verdonk R, Ollivier M, Seil R. Surgical management of degenerative meniscus lesions: the 2016 ESSKA meniscus consensus. Knee Surg Sports Traumatol Arthrosc. 2017;25(2):335-46.
10. Jarvinen TL, Guyatt GH. Arthroscopic surgery for knee pain. BMJ. 2016;354:i3934.
11. Malmivaara A. Benchmarking controlled trial-a novel concept covering all observational effectiveness studies. Ann Med. 2015;47(4):332-40.
12. Herrlin S, Hallander M, Wange P, Weidenhielm L, Werner S. Arthroscopic or conservative treatment of degenerative medial meniscal tears: a prospective randomised trial. Knee Surg Sports Traumatol Arthrosc. 2007;15(4):393-401.
13. Katz JN, Losina E. Surgery versus physical therapy for meniscal tear and osteoarthritis. N Engl J Med. 2013;369(7):677-8.
14. Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Kalske J, Jarvinen TL, Finnish degenerative meniscal lesion study (FIDELITY) group. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013;369(26):2515-24.
15. Yim JH, Seon JK, Song EK, Choi JI, Kim MC, Lee KB, Seo HY. A comparative study of meniscectomy and nonoperative treatment for degenerative horizontal tears of the medial meniscus. Am J Sports Med. 2013;41(7):1565-70.
16. Gauffin H, Tagesson S, Meunier A, Magnusson H, Kvist J. Knee arthroscopic surgery is beneficial to middle-aged patients with meniscal symptoms: a prospective, randomised, single-blinded study. Osteoarthr Cartil. 2014;22(11):1808-16.
17. Kise NJ, Risberg MA, Stensrud S, Ranstam J, Engebretsen L, Roos EM. Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: randomised controlled trial with two year follow-up. BMJ. 2016;354:i3740.
18. Petrou S, Gray A. Economic evaluation alongside randomised controlled trials: design, conduct, analysis, and reporting. BMJ. 2011;342:d1548.
19. McCabe C, Claxton K, Culyer AJ. The NICE cost-effectiveness threshold: what it is and what that means. Pharmacoeconomics. 2008;26(9):733-44.
20. Crum AJ, Leibowitz KA, Verghese A. Making mindset matter. BMJ. 2017;356:j674.
21. Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JA, Cochrane Bias methods group, Cochrane Statistical Methods Group. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.