Development of a core outcome set for clinical trials in facial aging: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

BACKGROUND: Facial aging is a concern for many patients. Wrinkles, loss of volume, and discoloration are common physical manifestations of aging skin. Genetic heritage, prior ultraviolet light exposure, and Fitzpatrick skin type may be associated with the rate and type of facial aging. Although many clinical trials assess the correlates of skin aging, there is heterogeneity in the outcomes assessed, which limits the quality of evaluation and comparison of treatment modalities. To address the inconsistency in outcomes, in this project we will develop a core set of outcomes that are to be evaluated in all clinical trials relevant to facial aging. METHODS/DESIGN: A long list of measureable outcomes will be created from four sources: (1) systematic medical literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Two rounds of Delphi processes with homogeneous groups of physicians and patients will be performed to prioritize and condense the list. At a consensus meeting attended by physicians, patients, and stakeholders, outcomes will be further condensed on the basis of participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. Subsequent to this, specific measures will be selected or created to assess these outcomes. DISCUSSION: The aim of this study is to develop a core outcome set and relevant measures for clinical trials relevant to facial aging. We hope to improve the reliability and consistency of outcome reporting of skin aging, thereby enabling improved evaluation of treatment efficacy and patient satisfaction. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) Initiative, accessible at http://www.comet-initiative.org/studies/details/737 . Core Outcomes Set Initiative, (CSG-COUSIN) accessible at https://www.uniklinikum-dresden.de/de/das-klinikum/universitaetscentren/zegv/cousin/meet-the-teams/project-groups/core-outcome-set-for-the-appearance-of-facial-aging . Protocol version date is 28 July 2016.

The modified Norwegian method of biceps tenodesis: how well does it work?

PURPOSE: The purpose of this study was to evaluate clinical outcomes and complications in a series of patients who underwent the modified Norwegian method (MNM) of biceps tenodesis by a single shoulder surgeon. METHODS: A retrospective review of charts from all patients who underwent the modified Norwegian method of biceps tenodesis by the senior author during a 5-year period between 2008 and 2013 was performed. After all patients were identified, informed consent was obtained and DASH and ASES surveys were administered. Inclusion criteria for the study were a minimum 2-year follow-up after MNM tenodesis and appropriate adherence to DASH and ASES survey protocol. Data obtained included: demographic data, time to follow-up, hand dominance, concomitant procedures, workman's compensation (WC) status, DASH and ASES surveys, and complications. A complication was defined as rupture of the tenodesis or post-operative infection. Residual shoulder pain was considered as treatment failure. The data were then analysed using statistical software. In this time period, 94 biceps tenodeses using the MNM technique were performed. Follow-up rate was 75/94 patients (80 %). Of 75 patients, 15 (20 %) had an isolated tenodesis performed. RESULTS: There was no statistically significant difference in DASH or ASES scores when comparing isolated tenodesis patients to those who had concomitant procedures. WC patients had worse DASH and ASES scores (p = 0.016; p = 0.002). The complication rate was 2/75 (3 %), which were both ruptured tenodeses. Of 75 patients, 3 (4 %) experienced treatment failure with residual anterior shoulder pain. CONCLUSIONS: There is debate in the literature regarding the optimal method of biceps tenodesis. This paper demonstrates that the MNM tenodesis appears to be a simple, efficient, and effective alternative to other methods of biceps tenodesis with subjective outcome scores and complication rates that parallel other methods previously described in the literature. LEVEL OF EVIDENCE: IV.

The modified norwegian method of biceps tenodesis.

This technical note describes a method of biceps tenodesis called the Modified Norwegian Method that is an all-arthroscopic, intra-articular, bony biceps tenodesis that uses a suture shuttle passer through an anterosuperolateral portal. It allows for easy passage of suture through the long head of the biceps tendon while one is viewing through the posterior portal. We believe this method to be a very reasonable and simple method of biceps tenodesis that has complication rates similar to those described for subpectoral and other methods of fixation.