William J. Gillespie

Effectiveness of hip protectors for preventing hip fractures in elderly people: systematic review

Abstract Objectives To present the updated results of systematic review of the current evidence for the effectiveness of hip protectors from reports of completed randomised trials, and to explore the evolution of that evidence. Design Systematic review with meta-analysis. Data sources Cochrane Bone, Joint, and Muscle Trauma Group trials register (January 2005), Cochrane central register of controlled trials (Cochrane Library Issue 1, 2005), Medline (1966 to January 2005), Embase (1988 to January 2005), and CINAHL (1982 to December 2004). Other databases and reference lists of relevant articles were searched and some trialists were contacted. Review methods Randomised or quasirandomised controlled trials reporting the incidence of hip fractures, pelvic fractures, and other fractures in elderly people offered hip protectors compared with a control group that was not. Results Outcomes for fracture were available from 14 randomised and quasirandomised trials. Pooling of data from 11 trials carried out in nursing or residential care settings, including six cluster randomised studies, showed evidence of a marginally statistically significant reduction in incidence of hip fracture (relative risk 0.77, 95% confidence interval 0.62 to 0.97). Pooling of data from three individually randomised trials of 5135 community dwelling participants showed no reduction in hip fracture incidence with provision of hip protectors (1.16, 0.85 to 1.59). No evidence was found of any significant effect of hip protectors on incidence of pelvic or other fractures. No important adverse effects of hip protectors were reported, but compliance, particularly in the long term, was poor. Conclusions On the basis of early reports of randomised trials, hip protectors were advocated. Accumulating evidence indicates that hip protectors are an ineffective intervention for those living at home and that their effectiveness in an institutional setting is uncertain.

Long-Term Follow-Up for Mortality and Cancer in a Randomized Placebo-Controlled Trial of Vitamin D3 and/or Calcium (RECORD Trial)

CONTEXT Vitamin D or calcium supplementation may have effects on vascular disease and cancer. OBJECTIVE Our objective was to investigate whether vitamin D or calcium supplementation affects mortality, vascular disease, and cancer in older people. DESIGN AND SETTING The study included long-term follow-up of participants in a two by two factorial, randomized controlled trial from 21 orthopedic centers in the United Kingdom. PARTICIPANTS Participants were 5292 people (85% women) aged at least 70 yr with previous low-trauma fracture. INTERVENTIONS Participants were randomly allocated to daily vitamin D(3) (800 IU), calcium (1000 mg), both, or placebo for 24-62 months, with a follow-up of 3 yr after intervention. MAIN OUTCOME MEASURES All-cause mortality, vascular disease mortality, cancer mortality, and cancer incidence were evaluated. RESULTS In intention-to-treat analyses, mortality [hazard ratio (HR) = 0.93; 95% confidence interval (CI) = 0.85-1.02], vascular disease mortality (HR = 0.91; 95% CI = 0.79-1.05), cancer mortality (HR = 0.85; 95% CI = 0.68-1.06), and cancer incidence (HR = 1.07; 95% CI = 0.92-1.25) did not differ significantly between participants allocated vitamin D and those not. All-cause mortality (HR = 1.03; 95% CI = 0.94-1.13), vascular disease mortality (HR = 1.07; 95% CI = 0.92-1.24), cancer mortality (HR = 1.13; 95% CI = 0.91-1.40), and cancer incidence (HR = 1.06; 95% CI = 0.91-1.23) also did not differ significantly between participants allocated calcium and those not. In a post hoc statistical analysis adjusting for compliance, thus with fewer participants, trends for reduced mortality with vitamin D and increased mortality with calcium were accentuated, although all results remain nonsignificant. CONCLUSIONS Daily vitamin D or calcium supplementation did not affect mortality, vascular disease, cancer mortality, or cancer incidence.

Accidents in older people living at home: a community-based study assessing prevalence, type, location and injuries

Objectives:To assess the prevalence, type, location of and injuries from home accidents, including falls and other accidents, and to explore whether variables including socio‐demographic characteristics, medication use and home hazards were associated with all home accidents and falls.

A systematic review of the skeletal effects of estrogen therapy in postmenopausal women. II. An assessment of treatment effects

PURPOSE To combine the results of randomized controlled trials to provide overall estimates of the effect of estrogen treatment on fracture rates and measures of bone mass. DATA SOURCES Articles on estrogen treatment for osteoporosis published between 1977 and 1995 were identified. STUDY SELECTION Studies selected were randomized controlled trials of the efficacy of estrogens in preventing loss of bone mass or fractures in postmenopausal women. DATA EXTRACTION Data extraction and quality assessment were performed in duplicate, with assistance of a manual. Raters were blinded as to authors and their affiliations and the publication details. With estimates of bone mass, the treatment effect size was defined as the difference in the mean annual change in bone mass between the treatment and control groups divided by the pooled standard deviation for change. In the case of fractures, efficacy was measured as the reduction in the numbers of individuals experiencing new fractures with treatment. Effect sizes were pooled using the random effects model. RESULTS Thirty-seven studies met the criteria for inclusion in the systematic review. Only one small secondary prevention trial contained evaluable data on vertebral fractures. This study found a fracture relative risk of 0.63 (95% confidence interval, CI 0.28-1.43) with estrogen treatment. There was more information on the effects of treatment on bone mass. Overall effect sizes ranged between 0.5 and 2.5 standard deviation (SD) units for change. A dose-response relationship was apparent but high doses of estrogens were not associated with effect sizes greater than those observed with recommended doses. There was no significant difference in efficacy between transdermal and oral administration of estrogens. Pooling of paired data from secondary prevention studies indicated that treatment effect sizes were smaller at the hip (0.92, 95% CI 0.3-1.5 SD units) than at the spine (2.1, 95% CI 0.9-3.3 SD units). No significant effects of co-intervention with calcium, progestogens or androgens were seen, although an additive effect of higher doses of calcium could not be ruled out. CONCLUSIONS Clear-cut effects of estrogens in attenuating the postmenopausal decline in estimated bone mass were apparent in this literature. However, the trials were short-term and provide inadequate evidence on the effects of treatment on fracture risk.

Meta-analyses of small numbers of trials often agree with longer-term results.

OBJECTIVE Many systematic reviews include only a few studies. It is unclear whether recommendations based on these will be correct in the longer term; hence, this article explores whether meta-analyses give reliable results after only a few studies. STUDY DESIGN AND SETTING Cumulative meta-analysis of data from 65 meta-analyses from 18 Cochrane systematic reviews was carried out. Various measures of closeness to the pooled estimate from all trials after three and five trials were included. Changes during the accumulation of evidence were noted. RESULTS The 95% confidence interval included the final estimate in 72% of meta-analyses after three studies and in 83% after five studies. It took a median of four (interquartile range: 1.25-6) studies to get within 10% of the final point estimate. Agreement between the results at three and five studies and the final estimate was not predicted by the number of participants, the number of events, τ(2), or I(2). Estimates could still change substantially after many trials were included. CONCLUSION Many of the conclusions drawn from systematic reviews with small numbers of included studies will be correct in the long run, but it is not possible to predict which ones.

Moving towards evidence-based healthcare for musculoskeletal injuries: featuring the work of the Cochrane Bone, Joint and Muscle Trauma Group

Due to their high incidence and associated morbidity and mortality, musculoskeletal injuries place an enormous burden on society. For example, in the 2004 to 2005 period 62,000 people with hip fracture accounted for 2.9% of the total number of hospital bed days in England. Between 12% and 37% of people with hip fracture die in the first year. Of the survivors, most are less mobile and many lose their independence. Soft-tissue joint injuries during sports and exercise-related activities in young adults constitute another important group. Of these, ankle sprain is the most common single injury and it predisposes people to further recurrence. Members of the Cochrane Bone, Joint and Muscle Trauma Group prepare systematic reviews (Cochrane Reviews) of the evidence for interventions used in the prevention and management of musculoskeletal injuries. These reviews serve to facilitate evidence-based decision making by policy makers, healthcare professionals and consumers, and to guide future research. This article focuses on two major groups of injuries: osteoporotic fractures and soft-tissue joint injuries, and discusses some of the fundamental issues and questions associated with the prevention and management of these. Drawing insights from relevant Cochrane Reviews, this article examines the different approaches used for preventing, and the role of surgery and immobilisation for treating, these injuries. Brief illustrations of the inherent complexity of rehabilitation are also provided. This article also gives examples of how these reviews are helping to inform healthcare choices and practice, and guide research in this area.

Finding current evidence: search strategies and common databases.

With more than 100 orthopaedic, sports medicine, or hand surgery journals indexed in MEDLINE, it is no longer possible to keep abreast of developments in orthopaedic surgery by reading a few journals each month. Electronic resources are easier to search and more current than most print sources. We provide a practical approach to finding useful information to guide orthopaedic practice. We focus first on where to find the information by providing details about many useful databases and web links. Sources for identifying guidelines, systematic reviews, and randomized controlled trials are identified. The second section discusses how to find the information, from the first stage of formulating a question and identifying the concepts of interest, through to writing a simple strategy. Sources for additional self-directed learning are provided.

A systematic review of the skeletal effects of estrogen therapy in postmenopausal women. I. An assessment of the quality of randomized trials published between 1977 and 1995

PURPOSE To examine the quality of published randomized controlled trials of the effects of estrogen treatment on fracture risk and measures of bone mass. DATA SOURCES Articles on estrogen treatment for osteoporosis published between 1977 and 1995 were identified by searching Medline and Excerpta Medica databases and bibliographies of original papers and published reviews. STUDY SELECTION Studies selected were randomized controlled trials of the efficacy of estrogens in preventing loss of bone mass or fractures in postmenopausal women. DATA EXTRACTION Data extraction and quality assessment were performed in duplicate, with assistance of a manual. Raters were blinded as to authors and their affiliations and the publication details. RESULTS Of 99 eligible randomized controlled trials published between 1977 and 1995, eight included no extractable data, and 23 contained results that were published in duplicate. Total quality scores increased over time, but this was accounted for by improvements only in the measurement technologies used to estimate bone mineral content or density. There was no improvement in the quality of randomization methods, the extent to which withdrawals were accounted for, or in the baseline comparability of treated and control patients. Neither sample sizes nor durations of follow-up increased over time. CONCLUSIONS This body of literature fails to address whether estrogen therapy reduces fracture rates, and does not allow for comparison of the effects of different active therapies on change in bone density. Although there were improvements in the techniques for estimating bone mass and delivering estrogen treatment, the studies published in the 1990s were no more informative for making clinical or policy decisions than those published in the 1970s.

The Cochrane Collaboration: a leading role in producing reliable evidence to inform healthcare decisions in musculoskeletal trauma and disorders.

Systematic reviews are a key component of evidence-based practice. A valuable and accessible source of good quality systematic reviews on topics in musculoskeletal trauma and disorders is the Cochrane Database of Systematic Reviews, published in The Cochrane Library. These reviews are produced by members of The Cochrane Collaboration, an international not-for-profit organization that aims to make up-to-date, accurate information about the effects of healthcare readily available worldwide. Contributions from orthopedic specialists in India and neighboring countries are required to make the Cochrane Database an even more useful and comprehensive resource of reliable evidence. Linked with this is the opportunity for orthopedic specialists to take a leading role in generating the evidence to inform their practice.

Systematic Reviews, Meta-Analyses, and Methodology

To The Editor: We have been encouraged by the explicit emphasis on evidence-based orthopaedics in The Journal, and we read with great interest “Meta-Analyses in Orthopaedic Surgery. A Systematic Review of Their Methodologies” (83-A: 15-24, Jan. 2001), by Bhandari et al. This article raised some important points, one being that adherence to strict scientific methodology can limit bias and improve the validity of meta-analyses. However, we would like to comment on the methodology and consequent findings of their study. The first issue is their omission of relevant studies published in the Cochrane Database of Systematic Reviews. As Bhandari et al. stated, they consulted this database in their search for meta-analyses, yet some thirty to fifty systematic reviews available in this database in 1999 were not included, which we find puzzling. Omission of these reviews, which, if included, would have more than doubled the number of reviews of fracture treatment, results in a distorted picture of the information that is available to the orthopaedic specialist. Moreover, as acknowledged by Bhandari et al., there is evidence that these reviews have higher scientific quality than …