Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in wards for older people

Drahota, Amy; Ward, Derek; Udell, Julie; Soilemezi, Dia; Ogollah, Reuben; Higgins, Bernard; Dean, Tara; Severs, Martin

doi:10.1093/ageing/aft067

Cited by 45 publications

(168 citation statements)

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“…This will, in turn, determine the total number of participants in the study. Drahota et al 5 and Teut et al 14 are examples of this. In our simulations we applied this situation to studies involving both small and large natural cluster sizes.…”

Section: Overview Of Pilot Studies For Cluster Randomised Trialsmentioning

confidence: 96%

“…The pilot study examples [5][6][7][8][14][15][16][17][18][19][20] are representative of a range of settings and vary in the included numbers of clusters. All involve randomisation of clusters into two or three groups, seven with equal allocation and three in which there was one extra cluster either in the intervention or control group.…”

Section: Overview Of Pilot Studies For Cluster Randomised Trialsmentioning

confidence: 99%

“…Four of the examples were conducted in hospital in-patients facilities and include as clusters: designated elderly care hospital bays in wards in England (one designated bay from each of eight hospitals randomised into two groups of four) 5 ; adult non-maternity in-patient wards from two NHS Trusts in London (18 hospital wards randomised into three groups of six) 15 ; UK general hospitals admitting emergency Acute Upper Gastrointestinal Bleeding cases (six academic centres randomised into two groups of three) 16 and in-patient rehabilitation centres in New Zealand (four centres randomised into two groups of two). 20 Three studies were conducted in community-based health care facilities or pharmacies; government primary health care and dispensary centres in Tanzania (36 dispensaries randomised into two groups of 18) 8 ; primary care Family Medicine Groups (FMGs) from two selected health regions in Canada (four FMGs randomised to two groups of two, with one additional late entry added to control group) 18 ; and Scottish community pharmacies (12 pharmacies randomised into two groups of six).…”

Section: Overview Of Pilot Studies For Cluster Randomised Trialsmentioning

confidence: 99%

“…From the definition earlier, the overarching objective of a pilot study is to assess the feasibility of a main trial, an objective often stated in reports of pilot studies for cluster randomised trials. [5][6][7][8] However, investigators are usually interested in addressing the feasibility of some specific aspects of a trial. Broadly these aspects are: (i) sample size of the main trial; (ii) recruitment and randomisation; (iii) implementation of interventions; (iv) data collection and outcomes; (v) harms, benefits, and potential effectiveness.…”

Section: Introductionmentioning

confidence: 99%

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How big should the pilot study for my cluster randomised trial be?

Eldridge

Costelloe

Kahan

et al. 2015

Stat Methods Med Res

116

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There is currently a lot of interest in pilot studies conducted in preparation for randomised controlled trials. This paper focuses on sample size requirements for external pilot studies for cluster randomised trials. We consider how large an external pilot study needs to be to assess key parameters for input to the main trial sample size calculation when the primary outcome is continuous, and to estimate rates, for example recruitment rates, with reasonable precision. We used simulation to provide the distribution of the expected number of clusters for the main trial under different assumptions about the natural cluster size, intra-cluster correlation, eventual cluster size in the main trial, and various decisions made at the piloting stage. We chose intra-cluster correlation values and pilot study size to reflect those commonly reported in the literature. Our results show that estimates of sample size required for the main trial are likely to be biased downwards and very imprecise unless the pilot study includes large numbers of clusters and individual participants. We conclude that pilot studies will usually be too small to estimate parameters required for estimating a sample size for a main cluster randomised trial (e.g. the intra-cluster correlation coefficient) with sufficient precision and too small to provide reliable estimates of rates for process measures such as recruitment or follow-up rates.

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Section: Overview Of Pilot Studies For Cluster Randomised Trialsmentioning

confidence: 96%

Section: Overview Of Pilot Studies For Cluster Randomised Trialsmentioning

confidence: 99%

Section: Overview Of Pilot Studies For Cluster Randomised Trialsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

How big should the pilot study for my cluster randomised trial be?

Eldridge

Costelloe

Kahan

et al. 2015

Stat Methods Med Res

116

View full text Add to dashboard Cite

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Preliminary clinical findings suggest that compliant flooring may reduce the incidence and severity of fallrelated injuries in long-term care (Knoefel et al, 2013) and acute-care settings (Drahota et al, 2013). However, there is concern that manoeuvring wheeled equipment on compliant flooring could expose care staff to potentially harmful pushing forces (Drahota et al, 2013;Wynn et al, 2011).

…”

mentioning

confidence: 99%

Effects of Compliant Flooring Systems and Resident Weight on Hand Forces When Pushing Floor-Based Lifts and Wheelchairs among Long-Term Care Staff

Lachance

Korall

Russell

et al. 2015

Proceedings of the Human Factors and Ergonomics Society Annual

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Preliminary clinical findings suggest that compliant flooring may reduce the incidence and severity of fallrelated injuries in long-term care (Knoefel et al., 2013) and acute-care settings (Drahota et al., 2013). However, there is concern that manoeuvring wheeled equipment on compliant flooring could expose care staff to potentially harmful pushing forces (Drahota et al., 2013;Wynn et al., 2011). We measured the external resultant hand forces (initial and sustained) required for female direct care staff to push two floorbased lifts (conventional manual and motor-driven) (n=14) or a wheelchair (n=14), loaded with passengers of average (67 kg) and ninetieth percentile (90 kg) resident weights, over four flooring systems: concrete + vinyl, compliant (1" SmartCells) + vinyl, concrete + carpet, and compliant + carpet. We observed an interaction between lift type and floor system for initial (p < 0.001) and sustained (p < 0.001) forces. Independent of resident weight, mean forces were lower for the motor-driven lift than the conventional lift on all flooring conditions (by 34.8 -74.4 N for initial forces and by 14.1 -64.5 N for sustained forces). With the vinyl overlay, initial forces were higher on compliant than concrete subflooring when using the conventional lift (mean difference = 44.7 N, 47.7% increase, p < 0.001) and motor-driven lift (29.8 N, 45.8% increase, p < 0.001). Similarly, with the vinyl overlay, sustained resultant forces were higher on compliant subflooring than concrete subflooring when using the conventional lift (39.0 N, 88.2% increase, p < 0.001) and motor-driven lift (9.7 N, 29.0% increase, p < 0.001). With the carpet overlay, the differences between compliant and concrete subfloors were less pronounced than with the vinyl overlay for the conventional lift (F initial : 23.0 N higher, 14.9% increase, p < 0.001; F sustained : 15.6 N higher, 18.7% increase, p < 0.001) and absent when using the motor-driven lift (F initial : p = 0.975; F sustained : p = 0.999). We also observed an interaction between resident weight and lift type for initial (p = 0.004) and sustained forces (p < 0.001). Independent of flooring system, F initial was 18.6 N higher (13.5% increase, p < 0.001) and F sustained was 11.7 N higher (14.3% increase, p < 0.001) for the ninetieth percentile weight than the average weight for the conventional lift. In contrast, there were no differences in F initial (p = 0.200) and F sustained (p = 0.100) between the average and ninetieth percentile weight conditions for the motor-driven lift. Similar trends were observed when participants pushed the wheelchair. In summary, this study found that compliant subflooring increased the external hand forces required for female direct care staff to push floor-based lifts and wheelchairs compared to concrete subflooring, and these increases in force were greater when pushing over vinyl than carpet overlay. This study also demonstrated that a motor-driven lift substantially reduced push forces compared to a conventional manual lift. Thus, motor-driven lif...

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Interventions for preventing falls in older people in care facilities and hospitals

Cameron

Dyer²,

Panagoda

et al. 2018

Cochrane Database of Systematic Reviews

355

370

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Background Falls in care facilities and hospitals are common events that cause considerable morbidity and mortality for older people. This is an update of a review first published in 2010 and updated in 2012. Objectives To assess the effects of interventions designed to reduce the incidence of falls in older people in care facilities and hospitals. Search methods We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (August 2017); Cochrane Central Register of Controlled Trials (2017, Issue 8); and MEDLINE, Embase, CINAHL and trial registers to August 2017. Selection criteria Randomised controlled trials of interventions for preventing falls in older people in residential or nursing care facilities, or hospitals. Data collection and analysis One review author screened abstracts; two review authors screened full‐text articles for inclusion. Two review authors independently performed study selection, 'Risk of bias' assessment and data extraction. We calculated rate ratios (RaR) with 95% confidence intervals (CIs) for rate of falls and risk ratios (RRs) and 95% CIs for outcomes such as risk of falling (number of people falling). We pooled results where appropriate. We used GRADE to assess the quality of evidence. Main results Thirty‐five new trials (77,869 participants) were included in this update. Overall, we included 95 trials (138,164 participants), 71 (40,374 participants; mean age 84 years; 75% women) in care facilities and 24 (97,790 participants; mean age 78 years; 52% women) in hospitals. The majority of trials were at high risk of bias in one or more domains, mostly relating to lack of blinding. With few exceptions, the quality of evidence for individual interventions in either setting was generally rated as low or very low. Risk of fracture and adverse events were generally poorly reported and, where reported, the evidence was very low‐quality, which means that we are uncertain of the estimates. Only the falls outcomes for the main comparisons are reported here. Care facilities Seventeen trials compared exercise with control (typically usual care alone). We are uncertain of the effect of exercise on rate of falls (RaR 0.93, 95% CI 0.72 to 1.20; 2002 participants, 10 studies; I² = 76%; very low‐quality evidence). Exercise may make little or no difference to the risk of falling (RR 1.02, 95% CI 0.88 to 1.18; 2090 participants, 10 studies; I² = 23%; low‐quality evidence). There is low‐quality evidence that general medication review (tested in 12 trials) may make little or no difference to the rate of falls (RaR 0.93, 95% CI 0.64 to 1.35; 2409 participants, 6 studies; I² = 93%) or the risk of falling (RR 0.93, 95% CI 0.80 to 1.09; 5139 participants, 6 studies; I² = 48%). There is moderate‐quality evidence that vitamin D supplementation (4512 particip...

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Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in wards for older people

Abstract: future research should assess shock-absorbing flooring with better 'push/pull' properties and explore increased faller risk. We estimate a future trial will need 33,480-52,840 person bed-days per arm.

Cited by 45 publications

References 17 publications

How big should the pilot study for my cluster randomised trial be?

How big should the pilot study for my cluster randomised trial be?

Effects of Compliant Flooring Systems and Resident Weight on Hand Forces When Pushing Floor-Based Lifts and Wheelchairs among Long-Term Care Staff

Interventions for preventing falls in older people in care facilities and hospitals

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