Screening in the community to reduce fractures in older women (SCOOP): a random controlled trial

Shepstone L, et al; “Screening in the community to reduce fractures in older women (SCOOP): a random controlled trial”. Lancet. 2018 Feb 24;391(10122):741-747. doi: 10.1016/S0140-6736(17)32640-5. Epub 2017 Dec 16.

Lee Shepstone, Elizabeth Lenaghan, Cyrus Cooper, Shane Clarke, Rebekah Fong-Soe-Khioe, Richard Fordham, Neil Gittoes, Ian Harvey, Nick Harvey, Alison Heawood, Richard Holland, Amanda Howe, John Kanis, Tarnya Marshall, Terence O’Neill, Tim Peters, Niamh Redmond, David Torgerson, David Turner, Eugene McCloskey; for the SCOOP Study Team*

Commentary: Screening for fracture risk, at the start of this study in 2008, was not currently advocated in the UK, or elsewhere. This study interests me as a nurse, since once properly educated in osteoporosis and appropriate use of clinical evaluation tools, nurses are ideally positioned in Public Health, Long Term Care and Gerontology to provide this screening.

Imagine the healthcare systems cost savings, elders retained independence, and maintained quality of life if we involved our well-trained group of Certified Osteoporosis Nurses to appropriately apply Clinical Evaluation tools in order to help predict and prevent of future fractures.

Abstract

Summary

Background Despite effective assessment methods and medications targeting osteoporosis and related fractures, screening for fracture risk is not currently advocated in the UK. We tested whether a community-based screening intervention could reduce fractures in older women.

Methods We did a two-arm randomised controlled trial in women aged 70–85 years to compare a screening programme using the Fracture Risk Assessment Tool (FRAX) with usual management. Women were recruited from 100 general practitioner (GP) practices in seven regions of the UK: Birmingham, Bristol, Manchester, Norwich, Sheffield, Southampton, and York. We excluded women who were currently on prescription anti-osteoporotic drugs and any individuals deemed to be unsuitable to enter a research study (eg, known dementia, terminally ill, or recently bereaved). The primary outcome was the proportion of individuals who had one or more osteoporosis-related fractures over a 5-year period. In the screening group, treatment was recommended in women identified to be at high risk of hip fracture, according to the FRAX 10-year hip fracture probability. Prespecified secondary outcomes were the proportions of participants who had at least one hip fracture, any clinical fracture, or mortality; and the effect of screening on anxiety and health-related quality of life. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN 55814835.

Findings 12483 eligible women were identified and participated in the trial, and 6233 women randomly assigned to the screening group between April 15, 2008, and July 2, 2009. Treatment was recommended in 898 (14%) of 6233 women. Use of osteoporosis medication was higher at the end of year 1 in the screening group compared with controls (15% vs 4%), with uptake particularly high (78% at 6 months) in the screening high-risk subgroup. Screening did not reduce the primary outcome of incidence of all osteoporosis-related fractures (hazard ratio [HR] 0·94, 95% CI 0·85–1·03, p=0·178), nor the overall incidence of all clinical fractures (0·94, 0·86–1·03, p=0·183), but screening reduced the incidence of hip fractures (0·72, 0·59–0·89, p=0·002). There was no evidence of differences in mortality, anxiety levels, or quality of life.

Interpretation Systematic, community-based screening programme of fracture risk in older women in the UK is feasible, and could be effective in reducing hip fractures. Funding Arthritis Research UK and Medical Research Council”

This UK article went on to discuss, “… preliminary findings indicate that the cost per prevented osteoporotic related fracture is less than £4500, and the cost per prevented hip fracture is less than £8000. Additionally, the cost per quality-adjusted life-year gained, estimated under various scenarios, was less than £20 000”. The article concluded “…, despite no overall reduction in fractures, findings from this trial show that community screening, based on the FRAX probability of hip fracture, leads to a significant reduction in hip fractures in older women, though this finding needs to be interpreted with caution. Cost-effectiveness analyses are ongoing, but the SCOOP study provides promise of a community-based management strategy that might reduce hip fractures in the UK and elsewhere”.

Screening to prevent fragility fractures among adults 40 years and older in primary care

Shepstone L, et al; “Screening in the community to reduce fractures in older women (SCOOP): a random controlled trail”. Lancet. 2018 Feb 24;391(10122):741-747. doi: 10.1016/S0140-6736(17)32640-5. Epub 2017 Dec 16.

Michelle Gates1 , Jennifer Pillay1* , Guylène Thériault2 , Heather Limburg3 , Roland Grad2 , Scott Klarenbach4 , Christina Korownyk4 , Donna Reynolds5 , John J. Riva6,7, Brett D. Thombs8 , Gregory A. Kline9 , William D. Leslie10,11, Susan Courage3 , Ben Vandermeer1 , Robin Featherstone1 and Lisa Hartling1

Commentary: One of the most encouraging articles I came across was this Systematic Review to synthesize evidence related to screening to prevent fragility fractures and related mortality and morbidity among adults 40 years and older in primary care. This systematic review should help update and reset how Canada will move forward to predict and prevent future fractures, in our at-risk population.

Osteoporosis Canada’s 2010 Clinical Practice Guideline for the Diagnosis and Management of Osteoporosis ushered in a paradigm shift from treating bone density to preventing fractures, accomplished by prescribing non-pharmaceutical and pharmaceuticals therapies appropriately.

This paradigm shift was from a medical management model to fracture prevention, so we target the high-risk population; clinical evaluation using bone density and fracture risk assessment tools; to post-fracture care and preventing a second fracture; to decreasing calcium and increasing vitamin D. Over this past decade we have discovered amazing new therapies; managed rare events from medications; identified benefits and limitations of assessment tools and so much more.

Since the 1993 release of the, The Osteoporosis Book, with Rheumatologist Dr John Wade, and Foreword by Dr Harold Copp, I have been privileged to be educated by many of the world’s best, either personally or at Conferences. All with a generous view towards research, education and an interprofessional approach to clinical care. I have seen the development and evolution of nutrition and exercise, to recent medications that now build bone to prevent future fractures. I was in attendance at the 2016 American Society of Bone and Mineral Research (ASBMR) when they released a “Call for Action” to address this under-recognized and under- treated disease. It was the first time I have seen Nurses included in a large-scale approach to identifying, triaging or managing osteoporosis.

This is a complex field that often impacts people with co-morbidities. Seeing this Canadian Task Force on Preventive Health Care address screening to prevent fragility fractures is very exciting. This is were our well-trained Certified Osteoporosis Nurses should be involved.

I look forward to exciting possibilities in the near future. We can prevent the first fracture!

Abstract

Purpose: To inform recommendations by the Canadian Task Force on Preventive Health Care by systematically reviewing direct evidence on the effectiveness and acceptability of screening adults 40 years and older in primary care to reduce fragility fractures and related mortality and morbidity, and indirect evidence on the accuracy of fracture risk prediction tools. Evidence on the benefits and harms of pharmacological treatment will be reviewed, if needed to meaningfully influence the Task Force’s decision-making.

Methods: A modified update of an existing systematic review will evaluate screening effectiveness, the accuracy of screening tools, and treatment benefits. For treatment harms, we will integrate studies from existing systematic reviews. A de novo review on acceptability will be conducted. Peer-reviewed searches (Medline, Embase, Cochrane Library, PsycINFO [acceptability only]), grey literature, and hand searches of reviews and included studies will update the literature. Based on pre-specified criteria, we will screen studies for inclusion following a liberal-accelerated approach. Final inclusion will be based on consensus. Data extraction for study results will be performed independently by two reviewers while other data will be verified by a second reviewer; there may be some reliance on extracted data from the existing reviews. The risk of bias assessments reported in the existing reviews will be verified and for new studies will be performed independently. When appropriate, results will be pooled using either pairwise random effects meta-analysis (screening and treatment) or restricted maximum likelihood estimation with Hartun-Knapp-Sidnick-Jonkman correction (risk prediction model calibration). Subgroups of interest to explain heterogeneity are age, sex, and menopausal status. Two independent reviewers will rate the certainty of evidence using the GRADE approach, with consensus reached for each outcome rated as critical or important by the Task Force.

Discussion: Since the publication of other guidance in Canada, new trials have been published that are likely to improve understanding of screening in primary care settings to prevent fragility fractures. A systematic review is required to inform updated recommendations that align with the current evidence base.