Do we really allow patient decision-making in rotator cuff surgery? A prospective randomized study

Carlos Torrens, Joan Miquel, Fernando Santana, Carlos Torrens, Joan Miquel, Fernando Santana

Abstract

Background: There is a growing patient interest in being involved in the decision-making process. However, little information is provided on how this information should be structured. Does it make a difference, in patient treatment decision-making, whether information is given based on the benefits or on the side effects in rotator cuff disorders?

Methods: It is a prospective randomized study that includes patients diagnosed with rotator cuff tears. Patients were randomly allocated to either group A (benefit-inform) or group B (side effect-inform) and were asked to answer the following questions based on their assigned group: Group A: Your doctor informs you that you have a rotator cuff tear and states that if he/she surgically repairs your cuff tear you will improve and that the cuff remains healed at the 2-year follow-up in 71% of the cases where surgery is done. Would you choose surgery? Yes or No Group B: Your doctor informs you that you have a rotator cuff tear and that if he/she surgically repairs your cuff tear you will improve and that the cuff is torn again at 2-year follow-up in 29% of the cases where surgery is done. Would you choose surgery? Yes or No Age, gender, the shoulder affected and the functional status assessed through the Constant score were also recorded.

Results: 80 patients were randomized (43 to group A and 37 to group B). The patients assigned to group A (benefit) accepted surgery significantly more frequently than those assigned to group B (complication) (P = 0.000). In group A, 36 of 43 (84%) accepted surgery, compared to 17 of 37 (46%) in group B.

Conclusions: The way that information on rotator cuff disorders is provided strongly influences patients' treatment decisions.

Trial registration: ClinicalTrials.gov, NCT03205852 . Registered 29 June 2017. Retrospectively registered.

Keywords: Outcomes; Patient participation; Rotator cuff; Rotator cuff-repair; Shared decision-making.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Ethical Committee of Comité Etico de Investigación Clínica del Parc de Salut Mar with the number 2014/5625/I. All the patients included signed informed consent.

Consent for Publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram of the progress through the phases of a parallel-randomized trial of two groups

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