0000000000294378
AUTHOR
David Wood
The ceiling effects of patient reported outcome measures for total knee arthroplasty
Abstract Background Patient reported outcome measurements (PROMs) that exhibit a substantial ceiling effect show clustering of participant's scores towards the upper limit of a scale and consequently have low discriminatory power among high end scores. This study aimed to compare ceiling effects at 1 and 2 years postoperatively across commonly usedPROMs for TKA. Hypothesis We hypothesized, that the analyzed PROMs differ substantially in regards to their ceiling effect. Patients and methods Patients that underwent a primary unilateral TKA and completed pre-operative and post-operative questionnaires were included in the analysis. Participants completed the KOOS, KOOS-12, KOOS-JR, KOOS-PS, WO…
Minimal important change and minimum clinically important difference values of the KOOS-12 after total knee arthroplasty
Abstract Purpose The minimal important change (minimal amount of change vs. baseline that a patient recognizes as a clinical change) and minimum clinically important difference (smallest difference between two measurements that are deemed important by patients) are important values to evaluate the clinical relevance of changes over time and differences between groups. This study aims to establish these values for the KOOS-12 at 1 year postoperatively. Methods KOOS-12 scores were calculated from the full-length KOOS completed by patients undergoing primary TKA preoperatively and at 1 year follow up. Minimal important change (MIC) values were estimated using the anchor-based predictive modeli…
Chapter 22: Assuring the quality, safety and efficacy of HPV vaccines: The scientific basis of regulatory expectations pre- and post-licensure
The potential of human papillomavirus (HPV) vaccines will only be realized if the vaccine candidates under development prove to be safe and effective and can be consistently produced to define quality standards. Whilst the responsibility for delivering a safe and effective product rests with the vaccine producer, a vaccine requires a license to allow it to be placed on the market. Licensure is based on an evaluation of the safety and efficacy profile of a vaccine candidate by national regulatory authorities, ideally on the basis of internationally agreed, science-based specifications and procedures. For vaccines, these international specifications are developed by the World Health Organizat…
Effet plancher des auto-questionnaires pour l’évaluation des résultats des prothèses totales de genou
Abstract Background Patient reported outcome measurements (PROMs) that exhibit a substantial ceiling effect show clustering of participant's scores towards the upper limit of a scale and consequently have low discriminatory power among high end scores. This study aimed to compare ceiling effects at 1 and 2 years postoperatively across commonly used PROMs for TKA. Hypothesis We hypothesized, that the analyzed PROMs differ substantially in regards to their ceiling effect. Patients and methods Patients that underwent a primary unilateral TKA and completed pre-operative and post-operative questionnaires were included in the analysis. Participants completed the KOOS, KOOS-12, KOOS-JR, KOOS-PS, W…