Sonja Häckel1, Angela A Renggli2, Christoph E Albers2, Lorin M Benneker2, Moritz C Deml2, Sebastian F Bigdon2, Sufian S Ahmad3, Sven Hoppe2. 1. Department of Orthopaedic Surgery and Traumatology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010 Bern, Switzerland. sonja.haeckel@insel.ch. 2. Department of Orthopaedic Surgery and Traumatology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010 Bern, Switzerland. 3. Centrum für Muskuloskeletale Chirurgie (CMSC), Charité - Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany.
Abstract
BACKGROUND: The economic burden of vertebral compression fractures (VCF) caused by osteoporosis was estimated at 37 billion euros in the European Union in 2010. In addition, the incidence is expected to increase by 25% in 2025. The recommendations for the therapy of VCFs (conservative treatment versus cement augmentation procedures) are controversial, what could be partly explained by the lack of standardized outcomes for measuring the success of both treatments. Consensus on outcome parameters may improve the relevance of a study and for further comparisons in meta-analyses. The aim of this study was to analyze outcome measures from frequently cited randomized controlled trials (RCTs) about VCF treatments in order to provide guidance for future studies. MATERIAL AND METHODS: We carried out a systematic search of all implemented databases from 1973 to 2019 using the Web of Science database. The terms "spine" and "random" were used for the search. We included: Level I RCTs, conservative treatment or cement augmentation of osteoporotic vertebral fractures, cited ≥50 times. The outcome parameters of each study were extracted and sorted according to the frequency of use. RESULTS: Nine studies met the inclusion criteria. In total, 23 different outcome parameters were used in the nine analyzed studies. Overall, the five most frequently used outcome parameters (≥ 4 times used) were the visual analogue scale (VAS) for pain (n = 9), European Quality of Life-5 Dimensions (EQ-5D; n = 4) and Roland-Morris Disability Questionnaire (RMDQ, n = 4). CONCLUSION: With our study, we demonstrated that a large inconsistency exists between outcome measures in highly cited Level I studies of VCF treatment. Pain (VAS), followed by HrQoL (EQ-5D) and disability and function (RMDQ), opioid use, and radiological outcome (kyphotic angle, VBH, and new VCFs) were the most commonly used outcome parameters.
BACKGROUND: The economic burden of vertebral compression fractures (VCF) caused by osteoporosis was estimated at 37 billion euros in the European Union in 2010. In addition, the incidence is expected to increase by 25% in 2025. The recommendations for the therapy of VCFs (conservative treatment versus cement augmentation procedures) are controversial, what could be partly explained by the lack of standardized outcomes for measuring the success of both treatments. Consensus on outcome parameters may improve the relevance of a study and for further comparisons in meta-analyses. The aim of this study was to analyze outcome measures from frequently cited randomized controlled trials (RCTs) about VCF treatments in order to provide guidance for future studies. MATERIAL AND METHODS: We carried out a systematic search of all implemented databases from 1973 to 2019 using the Web of Science database. The terms "spine" and "random" were used for the search. We included: Level I RCTs, conservative treatment or cement augmentation of osteoporotic vertebral fractures, cited ≥50 times. The outcome parameters of each study were extracted and sorted according to the frequency of use. RESULTS: Nine studies met the inclusion criteria. In total, 23 different outcome parameters were used in the nine analyzed studies. Overall, the five most frequently used outcome parameters (≥ 4 times used) were the visual analogue scale (VAS) for pain (n = 9), European Quality of Life-5 Dimensions (EQ-5D; n = 4) and Roland-Morris Disability Questionnaire (RMDQ, n = 4). CONCLUSION: With our study, we demonstrated that a large inconsistency exists between outcome measures in highly cited Level I studies of VCF treatment. Pain (VAS), followed by HrQoL (EQ-5D) and disability and function (RMDQ), opioid use, and radiological outcome (kyphotic angle, VBH, and new VCFs) were the most commonly used outcome parameters.
Authors: Steven Boonen; Jan Van Meirhaeghe; Leonard Bastian; Steven R Cummings; Jonas Ranstam; John B Tillman; Richard Eastell; Karen Talmadge; Douglas Wardlaw Journal: J Bone Miner Res Date: 2011-07 Impact factor: 6.741
Authors: David F Kallmes; Bryan A Comstock; Patrick J Heagerty; Judith A Turner; David J Wilson; Terry H Diamond; Richard Edwards; Leigh A Gray; Lydia Stout; Sara Owen; William Hollingworth; Basavaraj Ghdoke; Deborah J Annesley-Williams; Stuart H Ralston; Jeffrey G Jarvik Journal: N Engl J Med Date: 2009-08-06 Impact factor: 91.245
Authors: E Hernlund; A Svedbom; M Ivergård; J Compston; C Cooper; J Stenmark; E V McCloskey; B Jönsson; J A Kanis Journal: Arch Osteoporos Date: 2013-10-11 Impact factor: 2.617