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Letter to the Editor: Is Criticism About Inherent Biases in Rigorous Orthopaedic Trials Prone to Biases?

      The field of orthopaedics has seen a surge of rigorous randomized controlled trials (RCTs) comparing commonly performed arthroscopic procedures with nonoperative treatment or sham surgery. Challenging old paradigms always meets fierce objection, and questioning the efficacy of surgery for degenerative conditions in the shoulder and knee is no different. Critics usually focus on various flaws in the trials that did not find evidence of benefits. “Inherent biases” invalidate the results, and hence the procedures that “have stood the test of time” should not be abandoned—we just know they work, and it’s all about selecting the right patients.
      • Hohmann E.
      • Shea K.
      • Scheiderer B.
      • Millett P.
      • Imhoff A.
      Indications for arthroscopic subacromial decompression. A level V evidence clinical guideline.
      In recent discourse, Hohmann et al. called for “credible, reliable, reproducible, and valid evidence.”
      • Hohmann E.
      • Shea K.
      • Scheiderer B.
      • Millett P.J.
      • Imhoff A.
      Author reply: Arthroscopic subacromial decompression. What are the indications? A level V evidence clinical guideline.
      We find it paradoxical that while they ask for reliable evidence, they first discredit moderate- to high-certainty evidence from a systematic review and base their own claims that subacromial decompression (SAD) is an effective procedure with “proven long-term outcomes” on 2 observational studies and 2 selected RCTs.
      • Norlin R.
      • Adolfsson L.
      Small full-thickness tears do well ten to thirteen years after arthroscopic subacromial decompression.
      • Farfaras S.
      • Sernert N.
      • Rostgard Christensen L.
      • Hallström E.K.
      • Kartus J.-T.
      Subacromial decompression yields a better clinical outcome than therapy alone: A prospective randomized study of patients with a minimum 10-year follow-up.
      • Jaeger M.
      • Berndt T.
      • Rühmann O.
      • Lerch S.
      Patients with impingement syndrome with and without rotator cuff tears do well 20 years after arthroscopic subacromial decompression.
      • Brox J.I.
      • Gjengedal E.
      • Uppheim G.
      • Bøhmer A.S.
      • Brevik J.I.
      • Ljunggren A.E.
      • et al.
      Arthroscopic surgery versus supervised exercises in patients with rotator cuff disease (stage II impingement syndrome): A prospective, randomized, controlled study in 125 patients with a 2 1/2-year follow-up.
      Regarding the long-term benefits, a Cochrane review that included the 2 studies also cited by Hohmann et al.
      • Hohmann E.
      • Shea K.
      • Scheiderer B.
      • Millett P.J.
      • Imhoff A.
      Author reply: Arthroscopic subacromial decompression. What are the indications? A level V evidence clinical guideline.
      found moderate-certainty evidence that SAD probably does not improve pain compared with exercises (mean difference [MD] in visual analog scale of 1 point; 95% confidence interval [CI] –0.25 to 2.25) and low-certainty evidence that surgery may improve function compared with exercises at 10 years (MD in Constant score of 9.5 points; 95% CI 1.9 to 17.1).
      • Karjalainen T.V.
      • Jain N.B.
      • Page C.M.
      • Lähdeoja T.A.
      • Johnston R.V.
      • Salamh P.
      • et al.
      Subacromial decompression surgery for rotator cuff disease.
      However, there was considerable risk of bias as well as imprecision.
      It seems that Hohmann et al.
      • Hohmann E.
      • Shea K.
      • Scheiderer B.
      • Millett P.J.
      • Imhoff A.
      Author reply: Arthroscopic subacromial decompression. What are the indications? A level V evidence clinical guideline.
      favor the positive findings from a single study by Farfaras et al.,
      • Farfaras S.
      • Sernert N.
      • Rostgard Christensen L.
      • Hallström E.K.
      • Kartus J.-T.
      Subacromial decompression yields a better clinical outcome than therapy alone: A prospective randomized study of patients with a minimum 10-year follow-up.
      while they see countless flaws in all of the other studies, including rigorously conducted placebo-controlled trials.
      • Beard D.J.
      • Rees J.L.
      • Cook J.A.
      • Rombach I.
      • Cooper C.
      • Merritt N.
      • et al.
      Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): A multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial.
      ,
      • Paavola M.
      • Malmivaara A.
      • Taimela S.
      • Kanto K.
      • Inkinen J.
      • Kalske J.
      • et al.
      Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: Randomised, placebo surgery controlled clinical trial.
      We wonder if the bias assessment by Hohmann et al.
      • Hohmann E.
      • Shea K.
      • Scheiderer B.
      • Millett P.J.
      • Imhoff A.
      Author reply: Arthroscopic subacromial decompression. What are the indications? A level V evidence clinical guideline.
      is biased to favor trials showing benefits.
      Further, Hohmann et al.
      • Hohmann E.
      • Shea K.
      • Scheiderer B.
      • Millett P.J.
      • Imhoff A.
      Author reply: Arthroscopic subacromial decompression. What are the indications? A level V evidence clinical guideline.
      elaborate their narrative with critical shoulder angle (CSA), which has nothing to do with reliable evidence supporting the use of SAD over nonoperative treatment. The concept of CSA has also been discussed in this journal.
      • Shenton D.W.
      Editorial commentary: It’s déjà vu all over again: Critical shoulder angle x-ray measurements do correlate with disease if the x-rays are carefully taken.
      • Barfod K.W.
      • Bjarnison A.O.
      • Kallemose T.
      • Sørensen T.J.
      The critical shoulder angle is associated with osteoarthritis in the shoulder but not rotator cuff tears. A retrospective case control study.
      • Degen R.M.
      Editorial commentary: Critical shoulder angle: perhaps not so “critical” for clinical outcomes following rotator cuff repair.
      CSA is an arbitrary measurement assessed in planar x-rays. Even the meta-analysis cited by Hohmann et al.
      • Hohmann E.
      • Shea K.
      • Scheiderer B.
      • Millett P.J.
      • Imhoff A.
      Author reply: Arthroscopic subacromial decompression. What are the indications? A level V evidence clinical guideline.
      concludes that “evidence is poor,”
      • Docter S.
      • Khan M.
      • Ekhtiari S.
      • Veillette C.
      • Paul R.
      • Henry P.
      • et al.
      The relationship between the critical shoulder angle and the incidence of chronic, full-thickness rotator cuff tears and outcomes after rotator cuff repair: A systematic review.
      and there is no existing evidence suggesting that CSA would modify the treatment effect when surgery is compared with exercises or placebo surgery.
      “Optimal patient selection” can be considered a myth until evidence of effect modifiers arises. We argue that if there were subpopulations that benefit from these procedures, we would have already identified them after 4 decades of using modern arthroscopy. It is simply not plausible that a meaningful effect keeps hiding because no one is able to define optimal inclusion criteria for efficacy studies. Mounting evidence shows that surgical treatment of degenerative conditions should not be automatically considered beneficial. We should require evidence from rigorous trials, just as we do elsewhere in medicine, before the procedures become accepted treatments. There is no room for double standards.
      It may be time for a paradigm shift: Embrace the natural course and accept degeneration until effective treatments arise.

      Supplementary Data

      References

        • Hohmann E.
        • Shea K.
        • Scheiderer B.
        • Millett P.
        • Imhoff A.
        Indications for arthroscopic subacromial decompression. A level V evidence clinical guideline.
        Arthroscopy. 2020; 36: 913-922
        • Hohmann E.
        • Shea K.
        • Scheiderer B.
        • Millett P.J.
        • Imhoff A.
        Author reply: Arthroscopic subacromial decompression. What are the indications? A level V evidence clinical guideline.
        Arthroscopy. 2020; 36: 1493-1495
        • Norlin R.
        • Adolfsson L.
        Small full-thickness tears do well ten to thirteen years after arthroscopic subacromial decompression.
        J Shoulder Elbow Surg. 2008; 17: 12S-16S
        • Farfaras S.
        • Sernert N.
        • Rostgard Christensen L.
        • Hallström E.K.
        • Kartus J.-T.
        Subacromial decompression yields a better clinical outcome than therapy alone: A prospective randomized study of patients with a minimum 10-year follow-up.
        Am J Sports Med. 2018; 46: 1397-1407
        • Jaeger M.
        • Berndt T.
        • Rühmann O.
        • Lerch S.
        Patients with impingement syndrome with and without rotator cuff tears do well 20 years after arthroscopic subacromial decompression.
        Arthroscopy. 2016; 32: 409-415
        • Brox J.I.
        • Gjengedal E.
        • Uppheim G.
        • Bøhmer A.S.
        • Brevik J.I.
        • Ljunggren A.E.
        • et al.
        Arthroscopic surgery versus supervised exercises in patients with rotator cuff disease (stage II impingement syndrome): A prospective, randomized, controlled study in 125 patients with a 2 1/2-year follow-up.
        J Shoulder Elbow Surg. 1999; 8: 102-111
        • Karjalainen T.V.
        • Jain N.B.
        • Page C.M.
        • Lähdeoja T.A.
        • Johnston R.V.
        • Salamh P.
        • et al.
        Subacromial decompression surgery for rotator cuff disease.
        Cochrane Database Syst Rev. 2019; 1: CD005619
        • Beard D.J.
        • Rees J.L.
        • Cook J.A.
        • Rombach I.
        • Cooper C.
        • Merritt N.
        • et al.
        Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): A multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial.
        Lancet. 2018; 391: 329-338
        • Paavola M.
        • Malmivaara A.
        • Taimela S.
        • Kanto K.
        • Inkinen J.
        • Kalske J.
        • et al.
        Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: Randomised, placebo surgery controlled clinical trial.
        BMJ. 2018; 362k2860
        • Shenton D.W.
        Editorial commentary: It’s déjà vu all over again: Critical shoulder angle x-ray measurements do correlate with disease if the x-rays are carefully taken.
        Arthroscopy. 2020; 36: 576-578
        • Barfod K.W.
        • Bjarnison A.O.
        • Kallemose T.
        • Sørensen T.J.
        The critical shoulder angle is associated with osteoarthritis in the shoulder but not rotator cuff tears. A retrospective case control study.
        Arthroscopy. 2017; 33: e53-e54
        • Degen R.M.
        Editorial commentary: Critical shoulder angle: perhaps not so “critical” for clinical outcomes following rotator cuff repair.
        Arthroscopy. 2018; 34: 2755-2756
        • Docter S.
        • Khan M.
        • Ekhtiari S.
        • Veillette C.
        • Paul R.
        • Henry P.
        • et al.
        The relationship between the critical shoulder angle and the incidence of chronic, full-thickness rotator cuff tears and outcomes after rotator cuff repair: A systematic review.
        Arthroscopy. 2019; 35: 3135-3143.e4