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1.  Evolving guidelines in the use of topical nonsteroidal anti-inflammatory drugs in the treatment of osteoarthritis 
Background
Nonsteroidal anti-inflammatory drugs (NSAIDs) are a standard treatment for osteoarthritis (OA), but the use of oral NSAIDs has been linked to an elevated risk for cardiovascular and gastrointestinal adverse events and renal toxicity. Topical NSAIDs are thought to afford efficacy that is comparable to oral formulations while reducing widespread systemic drug exposure, which may provide a benefit in terms of safety and tolerability. As a result, European treatment guidelines have, for many years, recommended the use of topical NSAIDs as a safe and effective treatment option for OA. Following the recent approval of several topical NSAID formulations by the US Food and Drug Administration, US treatment guidelines are increasingly recommending the use of topical NSAIDs as an alternative therapy and, in some cases, as a first-line option for OA. This commentary summarizes OA treatment guidelines that are currently available and discusses their potential evolution with regard to the increased inclusion of topical NSAIDs.
doi:10.1186/1471-2474-15-27
PMCID: PMC3926680  PMID: 24444047
Osteoarthritis; Pain; NSAIDs; Topical; Guidelines
2.  The reporting quality of studies investigating the diagnostic accuracy of anti-CCP antibody in rheumatoid arthritis and its impact on diagnostic estimates 
Background
Recently anti-CCP testing has become popular in the diagnosis of rheumatoid arthritis (RA). However, the inadequate reporting of the relevant diagnostic studies may overestimate and bias the results, directing scientists into making false decisions. The aim of the present study was to evaluate the reporting quality of studies used anti-CCP2 for the diagnosis of RA and to explore the impact of reporting quality on pooled estimates of diagnostic measures.
Methods
PubMed was searched for clinical studies investigated the diagnostic accuracy of anti-CCP. The studies were evaluated for their reporting quality according to STARD statement. The overall reporting quality and the differences between high and low quality studies were explored. The effect of reporting quality on pooled estimates of diagnostic accuracy was also examined.
Results
The overall reporting quality was relatively good but there are some essential methodological aspects of the studies that are seldom reported making the assessment of study validity difficult. Comparing the quality of reporting in high versus low quality articles, significant differences were seen in a relatively large number of methodological items. Overall, the STARD score (high/low) has no effect on the pooled sensitivities and specificities. However, the reporting of specific STARD items (e.g. reporting sufficiently the methods used in calculating the measures of diagnostic accuracy and reporting of demographic and clinical characteristics/features of the study population) has an effect on sensitivity and specificity.
Conclusions
The reporting quality of the diagnostic studies needs further improvement since the study quality may bias the estimates of diagnostic accuracy.
doi:10.1186/1471-2474-13-113
PMCID: PMC3488511  PMID: 22730931
Rheumatoid arthritis; Anti-cyclic citrullinated peptide 2; Anti-CCP2; Quality, Sensitivity; Specificity, Meta-analysis
3.  Comparison of published orthopaedic trauma trials following registration in Clinicaltrials.gov 
Background
After the Food and Drug Administration Modernization Act of 1997, the registration of all clinical trials became mandatory prior to publication. Our primary objective was to determine publication rates for orthopaedic trauma trials registered with ClinicalTrials.gov. We further evaluated methodological consistency between registration and publication.
Methods
We searched Clinical Trials.gov for all trials related to orthopaedic trauma. We excluded active trials and trials not completed by July 2009, and performed a systematic search for publications resulting from registered closed trials. Information regarding primary and secondary outcomes, intervention, study sponsors, and sample size were extracted from registrations and publications.
Results
Of 130 closed trials, 37 eligible trials resulted in 16 publications (43.2%). We found no significant differences in publication rates between funding sources for industry sponsored studies and nongovernment/nonindustry sponsored studies (p > 0.05). About half the trials (45%) did not include the NCT ID in the publication. Two (10%) publications had major changes to the primary outcome measure and ten (52.6%) to sample size.
Conclusions
Registration of orthopaedic trauma trials does not consistently result in publication. When trials are registered, many do not cite NCT ID in the publication. Furthermore, changes that are not reflected in the registry of the trial are frequently made to the final publication.
doi:10.1186/1471-2474-12-278
PMCID: PMC3266218  PMID: 22151841
Trial registration; Clinicaltrials.gov; Orthopaedic trauma
4.  Extending conceptual frameworks: life course epidemiology for the study of back pain 
Background
Epidemiological studies have identified important causal and prognostic factors for back pain, but these frequently only identify a proportion of the variance, and new factors add little to these models. Recently, interest has increased in studying diseases over the life course, stimulated by the 1997 book by Kuh and Ben-Shlomo, a move accompanied by important conceptual and methodological developments. This has resulted in improvements in the understanding of other conditions like cardiovascular and respiratory disease. This paper aims to examine how conceptual frameworks from life course epidemiology could enhance back pain research.
Discussion
Life course concepts can be divided into three categories. Concept 1: patterns over time, risk chains and accumulation. Simple 'chains of risk' have been studied - e.g. depression leading to back pain - but studies involving more risk factors in the chain are infrequent. Also, we have not examined how risk accumulation influences outcome, e.g. whether multiple episodes or duration of depression, throughout the life course, better predicts back pain. One-year back pain trajectories have been described, and show advantages for studying back pain, but there are few descriptions of longer-term patterns with associated transitions and turning points. Concept 2: influences and determinants of pathways. Analyses in back pain studies commonly adjust associations for potential confounders, but specific analysis of factors modifying risk, or related to the resilience or susceptibility to back pain, are rarely studied. Concept 3: timing of risk. Studies of critical or sensitive periods - crucial times of life which influence health later in life - are scarce in back pain research. Such analyses could help identify factors that influence the experience of pain throughout the life course.
Summary
Back pain researchers could usefully develop hypotheses and models of how risks from different stages of life might interact and influence the onset, persistence and prognosis of back pain throughout the life course. Adoption of concepts and methods from life course epidemiology could facilitate this.
doi:10.1186/1471-2474-11-23
PMCID: PMC2829505  PMID: 20122264
5.  Citation analysis of orthopaedic literature; 18 major orthopaedic journals compared for Impact Factor and SCImago 
Background
One of the disadvantages of the Impact Factor (IF) is self-citation. The SCImago Journal Rank (SJR) indicator excludes self-citations and considers the quality, rather than absolute numbers, of citations of a journal by other journals. The present study re-evaluated the influence of self-citation on the 2007 IF for 18 major orthopaedic journals and investigated the difference in ranking between IF and SJR.
Methods
The journals were analysed for self-citation both overall and divided into a general group (n = 8) and a specialized group (n = 10). Self-cited and self-citing rates, as well as citation densities and IFs corrected for self-citation (cIF), were calculated. The rankings of the 18 journals by IF and by SJR were compared and the absolute difference between these rankings (ΔR) was determined.
Results
Specialized journals had higher self-citing rates (p = 0.01, Δmedian = 9.50, 95%CI -19.42 to 0.42), higher self-cited rates (p = 0.0004, Δmedian = -10.50, 95%CI -15.28 to -5.72) and greater differences between IF and cIF (p = 0.003, Δmedian = 3.50, 95%CI -6.1 to 13.1). There was no significant correlation between self-citing rate and IF for both groups (general: r = 0.46, p = 0.27; specialized: r = 0.21, p = 0.56). When the difference in ranking between IF and SJR was compared between both groups, sub-specialist journals were ranked lower compared to their general counterparts (ΔR: p = 0.006, Δmedian = 2.0, 95%CI -0.39 to 4.39).
Conclusions
Citation analysis shows that specialized orthopaedic journals have specific self-citation tendencies. The correlation between self-cited rate and IF in our sample was large but, due to small sample size, not significant. The SJR excludes self-citations in its calculation and therefore enhances the underestimation in ranking of specialized journals.
doi:10.1186/1471-2474-11-4
PMCID: PMC2821374  PMID: 20047693
6.  The Keele community knee pain forum: action research to engage with stakeholders about the prevention of knee pain and disability 
Background
Involvement of users in health care research is central to UK health care policy, and guidelines for involvement exist. However, there are limited examples in rheumatology research. The aim of this study was to establish a community knee pain forum aimed at engaging stakeholders in design, dissemination and prioritisation of knee pain research.
Methods
Ten people were recruited to the forum representing a wide range of agencies. These included Weight Watchers, the leisure industry, Beth Johnson Foundation, health and social care professionals and the public. Three two-hour meetings over a two-year period were held. Experienced qualitative researchers facilitated each meeting. Written feedback after each meeting was elicited, and a short evaluation form was mailed to all members after the final meeting.
Results
Establishing and maintaining a forum of mixed members required careful preparation and ongoing support. Meetings had to be well-structured in order to allow for balanced participation of lay and professional users. Users contributed to the design of methods, provided ideas for dissemination and set priorities for further research. Clear documentation of meetings ensured that users' contributions to the research cycle were transparent.
Conclusion
Our knee pain forum illustrates that community engagement can have a positive impact on the development, dissemination and implementation of health research. Engaging with non-academic partners enables mutual learning and this enhances the quality of NHS research.
doi:10.1186/1471-2474-10-85
PMCID: PMC2728703  PMID: 19604353
7.  Research priorities for non-pharmacological therapies for common musculoskeletal problems: nationally and internationally agreed recommendations 
Background
Musculoskeletal problems such as low back pain, neck, knee and shoulder pain are leading causes of disability and activity limitation in adults and are most frequently managed within primary care. There is a clear trend towards large, high quality trials testing the effectiveness of common non-pharmacological interventions for these conditions showing, at best, small to moderate benefits. This paper summarises the main lessons learnt from recent trials of the effectiveness of non-pharmacological therapies for common musculoskeletal conditions in primary care and provides agreed research priorities for future clinical trials.
Methods
Consensus development using nominal group techniques through national (UK) and international workshops. During a national Clinical Trials Thinktank workshop in April 2007 in the UK, a group of 30 senior researchers experienced in clinical trials for musculoskeletal conditions and 2 patient representatives debated the possible explanations for the findings of recent high quality trials of non-pharmacological interventions. Using the qualitative method of nominal group technique, these experts developed and ranked a set of priorities for future research, guided by the evidence from recent trials of treatments for common musculoskeletal problems. The recommendations from the national workshop were presented and further ranked at an international symposium (hosted in Canada) in June 2007.
Results
22 recommended research priorities were developed, of which 12 reached consensus as priorities for future research from the UK workshop. The 12 recommendations were reduced to 7 agreed priorities at the international symposium. These were: to increase the focus on implementation (research into practice); to develop national musculoskeletal research networks in which large trials can be sited and smaller trials supported; to use more innovative trial designs such as those based on stepped care and subgrouping for targeted treatment models; to routinely incorporate health economic analysis into future trials; to include more patient-centred outcome measures; to develop a core set of outcomes for new trials of interventions for musculoskeletal problems; and to focus on studies that advance methodological approaches for clinical trials in this field.
Conclusion
A set of research priorities for future trials of non-pharmacological therapies for common musculoskeletal conditions has been developed and agreed through national (UK) and international consensus processes. These priorities provide useful direction for researchers and research funders alike and impetus for improvement in the quality and methodology of clinical trials in this field.
doi:10.1186/1471-2474-10-3
PMCID: PMC2631495  PMID: 19134184
8.  A simplified guide ruler from numeric table method in doing rotational osteotomy 
Background
Čobeljić et al. recently reported a numeric table method to provide precise rotational osteotomy which is a well established orthopaedic procedure. The numeric table requires four pages in length that is rather inconvenient during performing an osteotomy operation.
Methods
We thus develop our own method by summarizing the data of the four-page table into a small ruler, which is easy to carry and use in operation room. An electrical version of this ruler is also available. We also build a computer model to verify Čobeljić et al. method.
Results
The error of Čobeljić et al. is between -37% to 16% (mean ± SD = -6% ± 9%). We verify our ruler by calculating the absolute difference between our method and that of Čobeljić et al. The difference is less than 0.1 mm.
Conclusion
Our ruler is convenient for practical use for the rotational osteotomy procedure with equal precision. Further clinical verification is needed to justify its real significance.
doi:10.1186/1471-2474-9-87
PMCID: PMC2440753  PMID: 18557999
9.  Refining animal models in fracture research: seeking consensus in optimising both animal welfare and scientific validity for appropriate biomedical use 
Background
In an attempt to establish some consensus on the proper use and design of experimental animal models in musculoskeletal research, AOVET (the veterinary specialty group of the AO Foundation) in concert with the AO Research Institute (ARI), and the European Academy for the Study of Scientific and Technological Advance, convened a group of musculoskeletal researchers, veterinarians, legal experts, and ethicists to discuss, in a frank and open forum, the use of animals in musculoskeletal research.
Methods
The group narrowed the field to fracture research. The consensus opinion resulting from this workshop can be summarized as follows:
Results & Conclusion
Anaesthesia and pain management protocols for research animals should follow standard protocols applied in clinical work for the species involved. This will improve morbidity and mortality outcomes. A database should be established to facilitate selection of anaesthesia and pain management protocols for specific experimental surgical procedures and adopted as an International Standard (IS) according to animal species selected. A list of 10 golden rules and requirements for conduction of animal experiments in musculoskeletal research was drawn up comprising 1) Intelligent study designs to receive appropriate answers; 2) Minimal complication rates (5 to max. 10%); 3) Defined end-points for both welfare and scientific outputs analogous to quality assessment (QA) audit of protocols in GLP studies; 4) Sufficient details for materials and methods applied; 5) Potentially confounding variables (genetic background, seasonal, hormonal, size, histological, and biomechanical differences); 6) Post-operative management with emphasis on analgesia and follow-up examinations; 7) Study protocols to satisfy criteria established for a "justified animal study"; 8) Surgical expertise to conduct surgery on animals; 9) Pilot studies as a critical part of model validation and powering of the definitive study design; 10) Criteria for funding agencies to include requirements related to animal experiments as part of the overall scientific proposal review protocols. Such agencies are also encouraged to seriously consider and adopt the recommendations described here when awarding funds for specific projects. Specific new requirements and mandates related both to improving the welfare and scientific rigour of animal-based research models are urgently needed as part of international harmonization of standards.
doi:10.1186/1471-2474-8-72
PMCID: PMC1952063  PMID: 17678534
10.  Fracture prevention with vitamin D supplementation: considering the inconsistent results 
Background
A meta-analysis found that high dose vitamin D, different from low dose, decreased fracture risk by 23% for any nonvertebral fracture and by 26% for hip fracture. Unfortunately, however, this effect was not confirmed by recent trials. The aim of this paper is to explore if this inconsistency can be attributed to publication bias or heterogeneity of the trials.
Methods
The meta-analysis was extended with recent randomised controlled trials (RCTs) that were identified by a systematic review. Risk ratios (RR) and 95% confidence intervals (CI) were calculated from raw data. A funnel plot was used to explore the possibility of publication bias. Forest plots were used to investigate if vitamin D dose, concurrent use of calcium and target population were sources of heterogeneity. Linear regression analysis of log RR on adherence rate and achieved vitamin D level was used to study whether these variables were associated with fracture risk.
Results
A total of eleven trials was included: seven RCTs from the meta-analysis and four recently published. For any nonvertebral fracture, the funnel plot was asymmetrical because two small RCTs showed a large positive effect. This was not found for hip fracture. As reported in the meta-analysis, low dose vitamin D (<400 IU daily) was not effective. In contrast to the meta-analysis, however, the effect of high dose vitamin D (≥700 IU daily) seemed to be dependent on target population. For any nonvertebral fracture, the pooled RR was 0.80 (95% CI, 0.70–0.90) in institutionalised persons, and 0.88 (95% CI, 0.75–1.04) in the general population; for hip fracture, pooled RR 0.72 (95% CI, 0.59 to 0.88) and 1.04 (95% CI, 0.72–1.50), respectively. Other sources of heterogeneity were not clearly found. In the meta-analysis, pooled RRs were mainly based on small trials that showed a large effect or trials in institutionalised persons.
Conclusion
It is likely that the inconsistency between the meta-analysis and the recent trials is, at least partially, due to publication bias and differences in target population. High dose vitamin D may be effective in institutionalised persons but probably is not effective in the general population.
doi:10.1186/1471-2474-8-26
PMCID: PMC1821327  PMID: 17349055

Results 1-10 (10)