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Purpose Quadriceps tendon (QT) autograft ACL reconstruction was hypothesized to possess less anterior knee laxity, pivot shift laxity, and lower failure rates than hamstring tendon (HT) autografts. Methods Terms "hamstring tendon autograft" and "ACL reconstruction" or "quadriceps tendon autograft" and "ACL reconstruction" were searched in Embase and PubMed. Inclusion criteria required that studies included patients treated for primary ACL injury with reconstruction using either a QT autograft (Group 1) or a HT autograft (Group 2) and instrumented anterior knee laxity assessment. Extracted information included surgical fixation method, graft type, graft thickness or diameter, single vs. double bundle surgical method, publication year, time between the index knee injury and surgery, % women, initial and final subject number, subject age, follow-up length, side-to-side anterior knee laxity difference, Lysholm Score, Subjective IKDC score, anterior knee laxity side-to-side difference grade, ipsilateral pivot shift laxity grade, and failure rate. The Methodological Index for Nonrandomized Studies was used to evaluate study methodological quality. ResultsThe QT group (Group 1) had 17 studies and the HT group (Group 2) had 61 studies. Overall, Group 2 had greater pivot shift laxity (OR 1.29, 95% CI 1.05-1.59, p = 0.005). Group 2 suspensory femoral fixation had greater pivot shift laxity (OR 1.26, 95% CI 1.01-1.58, p = 0.02) than Group 1 compression femoral fixation. Group 2 compression femoral fixation also had more anterior knee laxity (OR 1.25, 95% CI 1.03-1.52, p = 0.01) than Group 1 compression femoral fixation and higher failure rates based on initial (OR 1.69, 95% CI 1.18-2.4, p = 0.002) and final (OR 1.89, 95% CI 1.32-2.71, p = 0.0003) subject number. Failure rate for HT compression femoral fixation was greater than suspensory femoral fixation based on initial (OR 2.08, 95% CI 1.52-2.84, p < 0.0001) and final (OR 2.26, 95% CI 1.63-3.16, p < 0.0001) subject number. Conclusions Overall, QT autografts had less pivot shift laxity and lower failure rates based on final subject number than HT autografts. Compression QT autograft femoral fixation had lower pivot shift laxity than suspensory HT autograft femoral fixation. Compression QT autograft femoral fixation had less anterior knee laxity and lower failure rates than compression HT autograft femoral fixation. Suspensory HT autograft femoral fixation had lower failure rates than compression HT autograft femoral fixation. Greater knee laxity and failure rates may be related to a combination of HT autograft diameter and configuration (tissue quality and dimensions, strands, bundles, and suturing method) variability and fixation mode. Level of evidence Level IV.

IMPORTANCE Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use. OBJECTIVE To develop international, consensus-based, PRO-specific ethical guidelines for clinical research. EVIDENCE REVIEWThe PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network's guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance.FINDINGS Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans. CONCLUSIONS AND RELEVANCEThe PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

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