A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery. The use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh) have been used to produce patches. However, clinical evidence on their use is limited. The patch augmented rotator cuff surgery (PARCS) feasibility study aimed to determine the design of a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. A mixed methods feasibility study of conducing a subsequent RCT. The project involved six stages: a systematic review of clinical evidence; a survey of the British Elbow and Shoulder Society’s (BESS) surgical membership; a survey of surgeon trialists; focus groups and interviews with stakeholders; a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. The BESS surgeons’ survey identified a variety of patches in use (105 (21%) responses received). Twenty-four surgeons (77%) completed the trialist survey relating to trial design. Four focus groups were conducted involving 24 stakeholders. Twenty-nine (67% of invited) individuals took part in the Delphi. Differing views were held on a number of aspects including the appropriate patient population for trial participation. Agreement on the key research questions and the outline of two potential RCTs were achieved through the Delphi study and the consensus meeting. Randomised comparisons of on-lay patch use for completed rotator cuff repairs, and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. The main limitation was that the findings were influenced by the participants, who might not necessarily reflect all stakeholders.

中文翻译：

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补片增强肩袖手术 (PARCS) 可行性研究的结果

肩袖撕裂是常见的致残肩部问题。症状包括疼痛、虚弱、行动不便和睡眠障碍。许多患者需要手术来修复撕裂；但是，失败率很高。迫切需要改善肩袖手术的结果。使用补片增强为愈合过程提供支持并改善患者预后具有新的希望。不同的材料（例如人类/动物皮肤或肠组织，以及完全合成的材料）和工艺（例如编织或网状）已被用于生产贴片。然而，关于它们使用的临床证据是有限的。补片增强肩袖手术 (PARCS) 可行性研究旨在确定一项最终随机对照试验 (RCT) 的设计，该试验旨在评估贴片增强肩袖手术修复的有效性和成本效益，同时为利益相关者和可行的。进行后续 RCT 的混合方法可行性研究。该项目涉及六个阶段：临床证据的系统审查；对英国肘肩协会 (BESS) 外科会员的调查；外科医生试验者的调查；焦点小组和与利益相关者的访谈；通过在线问卷和为期 2 天的共识会议进行的两轮德尔福研究。BESS 外科医生的调查确定了各种正在使用的贴片（收到 105（21%）个回复）。24 名外科医生 (77%) 完成了与试验设计相关的试验调查。进行了四个焦点小组，涉及 24 个利益相关者。29 人（受邀者的 67%）参加了 Delphi。在许多方面持有不同的意见，包括适合试验参与的患者人群。通过德尔菲研究和共识会议，就关键研究问题和两个潜在 RCT 的大纲达成一致。对用于完成肩袖修复的 on-lay 补片和用于部分肩袖修复的桥接补片的随机比较被确定为进一步研究的领域。还强调了评估贴片使用安全问题的观察性研究的价值。主要的限制是研究结果受到参与者的影响，