Nieuwe Weme, R.A. (2012) Effects of additional Commercial info versus solely Healthcare provided Education on the early outcome of Total Knee Arthroplasty. thesis, Medicine.
Full text available on request.Abstract
Background Direct-to-consumer advertising (DTCA) has been used as a successful marketing strategy in the pharmaceutical industry during the past 2 centuries. Following the growth of DTCA by the pharmaceutical companies, advertisements for medical devices and technologies appeared in 2003. Currently, it remains unknown if clinical benefits after total knee arthroplasty (TKA) are based on innovations in implant design, surgical techniques or patient expectations from the new implant, due to commercial based information. The aim of this study is to determine the influence of commercial based information on the early functional outcomes of TKA. Methods: A multicentre prospective hypothesis blinded cluster randomized controlled pilot study involving 40 patients was performed. We compared the Knee injury and Osteoarthritis Outcome Score (KOOS), Short-Form 12-Item Health Survey (SF-12), Self-Efficacy for Rehabilitation Outcome Scale (SER), Pain on a Numeric Rating Scale (NRS) and flexion between 2 groups, at 3 moments; at baseline, 2 weeks and 6 weeks after TKA. The control group received standard pre-operative information and the intervention group received, besides the standard information, an extra commercial folder containing additional information on the potential benefits of the High-Flex knee prosthesis. Results: The primary outcome, the change from baseline in the sub domain of the KOOS “Function in daily living” showed no significant difference between the control group and the intervention (High-Flex) group at 2 weeks (p=0.34) nor at 6 weeks (p=0.85). Furthermore there were no significant differences between groups, in change from baseline scores at 2 nor at 6 weeks, in secondary outcomes: KOOS sub domain “Pain”, SF-12 sub domain “Physical Function”, “Role Physical” and “Bodily Pain”, Active flexion, Pain on the NRS and in the satisfaction score. Conclusion: In conclusion, DTCA did not lead to a significant increase in the change from baseline scores at 2 nor at 6 weeks in function, measured by the sub domain “Function in daily living” of the KOOS in the intervention group (High-Flex) compared to the control group. Also there were no significant changes from baseline scores at 2 and 6 weeks in our secondary outcomes for pain, function, ROM and satisfaction rate. The follow-up at 3 months of this pilot and other future studies are of great importance to understand the implications and effects of DTCA in orthopaedics because of the growing market of advertising for medical devices, and to know how the function after TKA in patients can be influenced to gain better results.
| Item Type: | Thesis (Thesis) |
|---|---|
| Supervisor name: | Faculty supervisor: and Karthaus, dr A.J.M. Surgeon |
| Supervisor name: | Poolman, dr. R.W. orthopaedic surgeon and Onze Lieve Vrouwe Gasthuis, Amsterdam and Department of orthopaedic surgery |
| Faculty: | Medical Sciences |
| Date Deposited: | 25 Jun 2020 10:56 |
| Last Modified: | 25 Jun 2020 10:56 |
| URI: | https://umcg.studenttheses.ub.rug.nl/id/eprint/1676 |
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