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Editorial Commentary: Adverse Events After Rotator Cuff Repair Are Not Rare: Houston, We (May) Have a Problem

      Abstract

      The first national medical database registry was started in Sweden in 1975, and clinical registries have gained enormous popularity. Analysis of a large database of rotator cuff repair surgeries shows that adverse events may occur in almost 1 of 5 cases, showing the use of a register as a highly beneficial source of information. However, retrospective review of prospectively collected registry data has limitations and biases as well as benefits, including inconsistent reporting and recording of data, lack of control of confounding patient variables, and loss to follow-up.
      In 1970, Jack Swigert used the words “Houston, we’ve had a problem here,” and since then it has become one of the most popular erroneous quotations in history. I also have no doubt that it is the least-wanted phrase to be heard in our practice. But, even if we plan our treatment with NASA’s famous precision, we may eventually need to scream that out loud.
      Felsch, Mai, Durchholz, Flury, Lenz, Capellen, and Audigé, in their paper, “Complications Within 6 Months After Arthroscopic Rotator Cuff Repair: Registry-Based Evaluation According to a Core Event Set and Severity Grading,”
      • Felsch Q.
      • Mai V.
      • Durchholz H.
      • Flury M.
      • Lenz M.
      • Capellen C.
      • Audigé L.
      Complications within 6 months after arthroscopic rotator cuff repair: Registry-based evaluation according to a core event set and severity grading.
      caution us that arthroscopic rotator cuff repair is not childplay, and adverse events may occur in almost 1 in 5 cases. The strength of this paper is that the authors based their methodology on the review of a clinical register. By that means, they had a chance to review 1661 rotator cuff repairs performed in 1594 patients. The general idea is that studies based on such big cohorts give us a broader view of the problem and allow us to study more variables collected from more sources.
      • Varnum C.
      • Pedersen A.B.
      • Gundtoft P.H.
      • Overgaard S.
      The what, when and how of orthopaedic registers: an introduction into register-based research.
      Authors such as Felsch et al.
      • Felsch Q.
      • Mai V.
      • Durchholz H.
      • Flury M.
      • Lenz M.
      • Capellen C.
      • Audigé L.
      Complications within 6 months after arthroscopic rotator cuff repair: Registry-based evaluation according to a core event set and severity grading.
      show us how to make great use of the clinical registers, but such databases are not without limitations. One of the biggest challenges is consistency in gathering the data. Svantesson et al.
      • Svantesson E.
      • Senorski E.H.
      • Spindler K.P.
      • Ayeni O.R.
      • Fu F.H.
      • Karlsson J.
      • Samuelsson K.
      While modern medicine evolves continuously, evidence-based research methodology remains: How register studies should be interpreted and appreciated.
      highlighted the importance of responsibility in monitoring the enrollment and attrition of the cohort. This problem is also described by Felsch et al.,
      • Felsch Q.
      • Mai V.
      • Durchholz H.
      • Flury M.
      • Lenz M.
      • Capellen C.
      • Audigé L.
      Complications within 6 months after arthroscopic rotator cuff repair: Registry-based evaluation according to a core event set and severity grading.
      as they had a problem with proper identification of postoperative stiff shoulder cases, because different doctors used different codes to describe the same condition.
      • Felsch Q.
      • Mai V.
      • Durchholz H.
      • Flury M.
      • Lenz M.
      • Capellen C.
      • Audigé L.
      Complications within 6 months after arthroscopic rotator cuff repair: Registry-based evaluation according to a core event set and severity grading.
      The quality of the gathered data, lack of control of confounding, and possible inappropriate data input is discussed by a few other authors.
      • Varnum C.
      • Pedersen A.B.
      • Gundtoft P.H.
      • Overgaard S.
      The what, when and how of orthopaedic registers: an introduction into register-based research.
      On the other hand, registry databases are described as a less costly and time-consuming method of, let’s say, “observing” what we are actually achieving with our treatment than randomized control trials. They can also offer longer—if not close to endless—follow-up.
      • James S.
      • Rao S.V.
      • Granger C.B.
      Registry-based randomized clinical trials—A new clinical trial paradigm.
      • Smith A.J.
      • Dieppe P.
      • Vernon K.
      • Porter M.
      • Blom A.W.
      Failure rates of stemmed metal-on-metal hip replacements: Analysis of data from the National Joint Registry of England and Wales.
      • Varnum C.
      • Pedersen A.B.
      • Kjærsgaard-Andersen P.
      • Overgaard S.
      Comparison of the risk of revision in cementless total hip arthroplasty with ceramic-on-ceramic and metal-on-polyethylene bearings: Data on 11,096 patients from the Danish Hip Arthroplasty Registry.
      Felsch et al.
      • Felsch Q.
      • Mai V.
      • Durchholz H.
      • Flury M.
      • Lenz M.
      • Capellen C.
      • Audigé L.
      Complications within 6 months after arthroscopic rotator cuff repair: Registry-based evaluation according to a core event set and severity grading.
      show us that we can benefit from the use of medical registers. But we must not forget that it is vital for the success of medical registers to collect the data in a coherent way, and it is us—clinical practitioners—who have that responsibility. If we do it carelessly, as with the oxygen tank in the Apollo 13 mission, researchers like Felsch may feel as troubled as the Apollo 13 crew, and “Houston, we’ve had a problem here” may be heard again.

      Supplementary Data

      References

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        Complications within 6 months after arthroscopic rotator cuff repair: Registry-based evaluation according to a core event set and severity grading.
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        The what, when and how of orthopaedic registers: an introduction into register-based research.
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        While modern medicine evolves continuously, evidence-based research methodology remains: How register studies should be interpreted and appreciated.
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