Shock-absorbing flooring for fall-related injury prevention in older adults and staff in hospitals and care homes: the SAFEST systematic review.

BACKGROUND: Injurious falls in hospitals and care homes are a life-limiting and costly international issue. Shock-absorbing flooring may offer part of the solution; however, evidence is required to inform decision-making. OBJECTIVES: The objectives were to assess the clinical effectiveness and cost-effectiveness of shock-absorbing flooring for fall-related injury prevention among older adults in care settings. REVIEW METHODS: A systematic review was conducted of experimental, observational, qualitative and economic studies evaluating flooring in care settings targeting older adults and/or staff. Studies identified by a scoping review (inception to May 2016) were screened, and the search of MEDLINE, AgeLine and Scopus (to September 2019) was updated, alongside other sources. Two independent reviewers assessed risk of bias in duplicate (using Cochrane's Risk of Bias 2.0 tool, the Risk Of Bias In Non-randomized Studies - of Interventions tool, or the Joanna Briggs Institute's qualitative tool). RESULTS: Of the 22 included studies, 20 assessed the outcomes (three randomised controlled trials; and seven observational, five qualitative and five economic studies) on novel floors (n = 12), sports floors (n = 5), carpet (n = 5) and wooden subfloors (n = 1). Quantitative data related to 11,857 patient/resident falls (nine studies) and 163 staff injuries (one study). Qualitative studies included patients/residents (n = 20), visitors (n = 8) and staff (n = 119). Hospital-based randomised controlled trial data were too imprecise; however, very low-quality evidence indicated that novel/sports flooring reduced injurious falls from three per 1000 patients per day on vinyl with concrete subfloors to two per 1000 patients per day (rate ratio 0.55, 95% confidence interval 0.36 to 0.84; two studies), without increasing falls rates (two studies). One care home-based randomised controlled trial found that a novel underlay produces similar injurious falls rates (high-quality evidence) and falls rates (moderate-quality evidence) to those of a plywood underlay with vinyl overlays and concrete subfloors. Very low-quality data demonstrated that, compared with rigid floors, novel/sports flooring reduced the number of falls resulting in injury in care homes (26.4% vs. 33.0%; risk ratio 0.80, 95% confidence interval 0.70 to 0.91; three studies) and hospitals (27.1% vs. 42.4%; risk ratio 0.64, 95% confidence interval 0.44 to 0.93; two studies). Fracture and head injury outcomes were imprecise; however, hip fractures reduced from 30 per 1000 falls on concrete to 18 per 1000 falls on wooden subfloors in care homes (odds ratio 0.59, 95% confidence interval 0.45 to 0.78; one study; very low-quality evidence). Four low-quality economic studies concluded that shock-absorbing flooring reduced costs and improved outcomes (three studies), or increased costs and improved outcomes (one study). One, more robust, study estimated that shock-absorbing flooring resulted in fewer quality-adjusted life-years and lower costs, if the number of falls increased on shock-absorbing floors, but that shock-absorbing flooring would be a dominant economic strategy if the number of falls remained the same. Staff found moving wheeled equipment more difficult on shock-absorbing floors, leading to workplace adaptations. Staff injuries were observed; however, very low-quality evidence suggests that these are no less frequent on rigid floors. LIMITATIONS: Evidence favouring shock-absorbing flooring is of very low quality; thus, much uncertainty remains. CONCLUSIONS: Robust evidence is lacking in hospitals and indicates that one novel floor may not be effective in care homes. Very low-quality evidence indicates that shock-absorbing floors may be beneficial; however, wider workplace implications need to be addressed. Work is required to establish a core outcome set, and future research needs to more comprehensively deal with confounding and the paucity of hospital-based studies, and better plan for workplace adaptations in the study design. STUDY REGISTRATION: This study is registered as PROSPERO CRD42019118834. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 5. See the NIHR Journals Library website for further project information

Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial

Background Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear. Methods RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Findings Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1–10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4–82·5) in the no ADT group and 80·4% (76·6–83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths. Interpretation Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial

Background Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. Methods RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov , NCT00541047 . Findings Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Interpretation Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Funding Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society

The SAFEST Review

The SAFEST Review: The Shock-Absorbing Flooring Effectiveness SysTematic Review including older adults and staff in care setting

Advanced Biofuels and Beyond: Chemistry Solutions for Propulsion and Production

Leitner W, Klankermayer J, Pischinger S, Pitsch H, Kohse-Höinghaus K. Advanced Biofuels and Beyond: Chemistry Solutions for Propulsion and Production. Angewandte Chemie International Edition. 2017;56(20):5412-5452