Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640]

Background. Vertebroplasty is a promising but as yet unproven treatment for painful osteoporotic vertebral fractures. It involves radiographic-guided injection of various types of bone cement directly into the vertebral fracture site. Uncontrolled studies and two controlled quasi-experimental before-after studies comparing volunteers who were offered treatment to those who refused it, have suggested an early benefit including rapid pain relief and improved function. Conversely, several uncontrolled studies and one of the controlled before-after studies have also suggested that vertebroplasty may increase the risk of subsequent vertebral fractures, particularly in vertebrae adjacent to treated levels or if cement leakage into the adjacent disc has occurred. As yet, there are no completed randomised controlled trials of vertebroplasty for osteoporotic vertebral fractures. The aims of this participant and outcome assessor-blinded randomised placebo-controlled trial are to i) determine the short-term efficacy and safety (3 months) of vertebroplasty for alleviating pain and improving function for painful osteoporotic vertebral fractures; and ii) determine its medium to longer-term efficacy and safety, particularly the risk of further fracture over 2 years. Design. A double-blind randomised controlled trial of 200 participants with one or two recent painful osteoporotic vertebral fractures. Participants will be stratified by duration of symptoms (< and ≥ 6 weeks), gender and treating radiologist and randomly allocated to either the treatment or placebo. Outcomes will be assessed at baseline, 1 week, 1, 3, 6, 12 and 24 months. Outcome measures include overall, night and rest pain on 10 cm visual analogue scales, quality of life measured by the Assessment of Quality of Life, Osteoporosis Quality of Life and EQ-5D questionnaires; participant perceived recovery on a 7-point ordinal scale ranging from 'a great deal worse' to 'a great deal better'; disability measured by the Roland-Morris Disability Questionnaire; timed 'Up and Go' test; and adverse effects. The presence of new fractures will be assessed by radiographs of the thoracic and lumbar spine performed at 12 and 24 months. Discussion. The results of this trial will be of major international importance and findings will be immediately translatable into clinical practice. Trial registration. Australian Clinical Trial Register # [ACTRN012605000079640]. © 2008 Buchbinder et al; licensee BioMed Central Ltd.Rachelle Buchbinder, Richard H Osborne, Peter R Ebeling, John D Wark, Peter Mitchell, Chris J Wriedt, Lainie Wengier, David Connell, Stephen E Graves, Margaret P Staples and Bridie Murph

Stakeholder Satisfaction with the Australian Rheumatology Association Database (ARAD)

Background The Australian Rheumatology Association Database (ARAD) is a voluntary national registry for monitoring the long-term benefits and safety of biological disease-modifying anti-rheumatic drugs (bDMARDs) for inflammatory arthritis. Both rheumatologists and patients contribute data to the ARAD. Abstract: ObjectiveObjective To evaluate the satisfaction of patients and rheumatologists with the ARAD. Abstract: MethodsMethods Cross-sectional surveys were distributed to a random sample of 100 community-dwelling ARAD patients in 2007 and to rheumatologists attending the 2007 Australian Rheumatology Association (ARA) annual scientific meeting. Abstract: Survey questions included items about the usefulness of the ARAD, workload for participants, frequency of questionnaires, and experience of contact with ARAD staff. Abstract: ResultsResults A total of 92.5% of patients perceived the ARAD as very important (scoring 9-10 on a numeric rating scale). Patients reported minimal difficulty in completing questionnaires, and 95.0% indicated that a 6-month interval between questionnaires was reasonable. Of responding rheumatologists, 32.3%, 62.1%, and 53.8% indicated that the ARAD was very important (scoring 8-10) with respect to clinical information, research, and the profession, respectively, while 68% of those participating in the ARAD reported that the workload required to enroll patients was manageable and 30% found it difficult or onerous. Abstract: ConclusionConclusion Key stakeholders in the ARAD view it as an important resource and are satisfied with its operations. Efforts will be directed towards assisting those rheumatologists who find the associated workload difficult and to improving the perceived clinical value of information available from the ARAD.

Stakeholder satisfaction with the Australian Rheumatology Association Database (ARAD)

Background: The Australian Rheumatology Association Database (ARAD) is a voluntary national registry for monitoring the long-term benefits and safety of biological disease-modifying anti-rheumatic drugs (bDMARDs) for inflammatory arthritis. Both rheumatologists and patients contribute data to the ARAD.Objective: To evaluate the satisfaction of patients and rheumatologists with the ARAD.Methods: Cross-sectional surveys were distributed to a random sample of 100 community-dwelling ARAD patients in 2007 and to rheumatologists attending the 2007 AustralianRheumatologyAssociation (ARA) annual scientific meeting.Survey questions included items about the usefulness of the ARAD, workload for participants, frequency of questionnaires, and experience of contact with ARAD staff.Results: A total of 92.5% of patients perceived the ARAD as very important (scoring 9-10 on a numeric rating scale). Patients reported minimal difficulty in completing questionnaires, and 95.0% indicated that a 6-month interval between questionnaires was reasonable. Of responding rheumatologists, 32.3%, 62.1%, and 53.8% indicated that the ARAD was very important (scoring 8-10) with respect to clinical information, research, and the profession, respectively, while 68% of those participating in the ARAD reported that the workload required to enroll patients was manageable and 30% found it difficult or onerous.Conclusion: Key stakeholders in the ARAD view it as an important resource and are satisfied with its operations. Efforts will be directed towards assisting those rheumatologists who find the associated workload difficult and to improving the perceived clinical value of information available from the ARAD.<br /