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Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.

ABSTRACT: Randomized, clinical trials are commonly regarded as the highest level of evidence to support clinical decisions. Good Clinical Practice guidelines have been constructed to provide an ethical and scientific quality standard for trials that involve human subjects in a manner aligned with the Declaration of Helsinki. Originally designed to provide a unified standard of trial data to support submission to regulatory authorities, the principles may also be applied to other studies of human subjects. Although the application of Good Clinical Practice principles generally led to improvements in the quality and consistency of trial operations, these principles have also contributed to increasing trial complexity and costs. Alternatively, the growing availability of electronic health record data has facilitated the possibility for streamlined pragmatic clinical trials. The central tenets of Good Clinical Practice and pragmatic clinical trials represent potential tensions in trial design (stringent quality and highly efficient operations). In the present article, we highlight potential areas of discordance between Good Clinical Practice guidelines and the principles of pragmatic clinical trials and suggest strategies to streamline study conduct in an ethical manner to optimally perform clinical trials in the electronic age.

SUBMITTER: Mentz RJ

PROVIDER: S-EPMC4777975 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.

Mentz Robert J RJ Hernandez Adrian F AF Berdan Lisa G LG Rorick Tyrus T O'Brien Emily C EC Ibarra Jenny C JC Curtis Lesley H LH Peterson Eric D ED

Circulation 20160301 9

Randomized, clinical trials are commonly regarded as the highest level of evidence to support clinical decisions. Good Clinical Practice guidelines have been constructed to provide an ethical and scientific quality standard for trials that involve human subjects in a manner aligned with the Declaration of Helsinki. Originally designed to provide a unified standard of trial data to support submission to regulatory authorities, the principles may also be applied to other studies of human subjects. ...[more]

PMID: 26927005

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Project description:Abstract Biceps tendinopathy and superior labrum anterior posterior lesions are a common source of shoulder pain and disability and can be effectively treated with biceps tenodesis. There are a variety of open and arthroscopic tenodesis techniques, but no one technique has demonstrated superiority. Arthroscopic techniques often disregard the extra-articular portions of the biceps tendon as a potential source of pain. Open techniques address this concern; however, they can be associated with wound complications, increased blood loss, nerve injury, and disruptions to surgical workflow. Here, we describe an all arthroscopic tenodesis technique at the suprapectoral zone of the tendon. This method addresses extra-articular sources of pain, while limiting the potential pitfalls of open surgery. Technique Video Video 1 Narrated technique video. Standard posterior, anterior, lateral, and low anterior portals are used during the technique. Viewing from the posterior portal in a right shoulder the biceps anchor is debrided to a stable base. A BirdBeak device is inserted through the standard anterior portal and pierces the biceps tendon as laterally as possible, and an 18-gauge spinal needle is used to tease the suture from the BirdBeak device. After a standard subacromial decompression is performed the camera is inserted into the standard lateral portal, and an anterior subdeltoid bursectomy is performed to provide adequate visualization of the tenodesis site. An accessory low anterior portal is created about 1.5 cm proximal to the pectoralis major tendon insertion. The pectoralis major insertion site is used to aid in localization of the tendon just proximal to the subdeltoid portion of the tendon. An 11-blade is inserted through the low anterior portal and used to incise the transverse humeral ligament; the biceps tendon will often bulge from beneath the ligament at this step, confirming appropriate position. The bicep tendon is retracted with the probe, and a noncannulated 8-mm reamer is inserted into the low anterior portal and used to produce a unicortical tunnel. The tunnel’s edges are debrided using an arthroscopic shaver and the arthroscopic electrocautery device; the inferior portion of the tunnel must be smooth to prevent fraying of the tendon. The biceps tendon is then tensioned appropriately via tension pulled through the previously placed suture. A fork-tipped interference screw is then introduced through the low anterior portal to introduce the biceps tendon into the tenodesis site. The interference screw is then inserted and left 1 mm proud. The residual proximal bicep tendon is then amputated using an arthroscopic biter and removed through the lateral portal. The finished tenodesis site is probed and inspected, and a standard postoperative protocol is used.

Dataset Information

Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.

Publications

Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.

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