Logan PA 2021
論文
Logan PA, Horne JC, Gladman JR et al. (2021) Multifactorial falls prevention programme compared with usual care in UK care homes for older people: multicentre cluster randomised controlled trial with economic evaluation. bmj, 375.
https://doi.org/10.1136/bmj-2021-066991
https://www.bmj.com/content/375/bmj-2021-066991.short
著者を確認
https://orcid.org/0000-0002-6657-2381
Title
Multifactorial falls prevention programme compared with usual care in UK care homes for older people: multicentre cluster randomised controlled trial with economic evaluation
- falls: 転倒
- multicentre cluster randomised controlled trial: ランダム化比較試験の一つ。詳細は来週
- econbomic evaluation: ここでは扱いません
Participants 1657 consenting residents and 84 care homes. 39 were randomised to the intervention group and 45 were randomised to usual care.
Interventions Guide to Action for Care Homes (GtACH): a multifactorial fall prevention programme or usual care.
Results … The unadjusted incidence rate ratio for falls between 91 and 180 days was 0.57 (95% confidence interval 0.45 to 0.71, P<0.001) in favour of the GtACH programme (GtACH: six falls/1000 residents v usual care: 10 falls/1000).
Introduction
Falls are three times more common in care home residents than people of similar age living in the community.\(^1\)
1: Public Health England. Falls: Applying All Our Health. www.gov.uk/government/publications/falls-applying-all-our-health/falls-applying-all-our-health
Using a co-design approach, our research group developed and tested in a feasibility randomised controlled trial, an intervention programme to prevent falls in care home residents, the Guide to Action Care Home (GtACH) programme.\(^{7,8}\)
Note
feasibility: 実現可能性
引用文献 7 と 8 は、同じ研究グループの先行研究
Methods
We performed a multicentre, parallel, 1:1 cluster randomised controlled trial to evaluate the GtACH programme compared with usual care for the prevention of falls in older residents of long term care homes in the UK
Note
multicentre: 多施設
cluster-randomised controlled trial: 多施設研究で、施設内で介入群と対照群に分けるのではなく、施設をまるごと一つの群とする。
To be eligible the homes had to be long stay and registered to care for older people or those with dementia, have 10 or more residents, routinely record falls, and have the agreement of the care home owner.
Care homes were not eligible if they had participated in previous GtACH studies,8 provided care for those with learning difficulties, did not agree to the intervention being used, or were under special measures from the UK national regulator of care homes (the Care Quality Commission).
All residents in the recruited homes were eligible to participate, including those who lacked mental capacity to provide consent, except for residents who the care home staff determined to be in the last few days of life or who were receiving short term care or rehabilitation.
Site trial coordinators randomised care homes on a 1:1 basis to one of two parallel arms (the GtACH programme or usual care) using a bespoke computer generated pseudo-random code of variable block randomisation within strata (site, care home type (nursing, residential, dual registration)) provided by the Norwich Clinical Trials Unit through a secure web based randomisation service.
Note
block randomisation: ランダム化を単純に行うと、1:1 にならない。1:1 にするための手法。
strata: 層。ランダム化では、結果として２群に有意差が見られない様にしなければならない。（例えば性別など）層で属性で分けて、その中でランダム化する。
The researchers, resident participants, and staff informants were blind to allocation at consent and to baseline data collection.
Researchers collecting data remained blind to allocation but documented if they became unblinded. By the nature of the intervention, care home staff and resident participants could not be blind to allocation group.
Note
blind: 盲検化。
The theory was that staff are key to reducing fall rate in care facilities and that by numerous incremental actions, such as improved lighting, greater access to appropriate drinks, timely drug reviews, and monitoring the pattern of falls then the effect on an individual will be seen.
The main outcome measure was the fall rate at 91-180 days after randomisation.
Analyses were undertaken on an intention-to-treat basis according to a prespecified statistical analysis plan (available from author).
Note
Intention-to-treat (ITT) analysis is the preferred way to report randomized trial results. Final results are based on analysis of data from all the participants who were originally randomly assigned, whether or not they completed the trial.
A per-protocol analysis reports a study’s results by the treatment received and not by the group into which the participants were randomly assigned.
AMA Manual of Style 11th Edition p. 988
第110回 B 13
治療 A と治療 B との比較を目的としたランダム化比較試験〈無作為化比較対照試験〉を行った。割り付けと実際の治療人数の表を示す。
| 治療A を実際に行った | 治療B を実際に行った | 治療開始前 に死亡した | 合計 | |
|---|---|---|---|---|
| 治療A割付 | 110人 | 15人 | 4人 | 129人 |
| 治療B割付 | 6人 | 115人 | 0人 | 121人 |
| 合計 | 116人 | 130人 | 4人 | 250人 |
intention to treat〈ITT〉で２つの治療を比較するときに、治療 A と治療 B の組み合わせで正しいのはどれか。
Results
Recruitment took place between 1 November 2016 and 31 January 2018. Eighty four care homes were randomised: 39 to the GtACH programme and 45 to usual care.
Data for the primary outcome, fall rate at 91-180 days after randomisation, were available for 630 residents assigned to GtACH and 712 assigned to usual care (table 2).
Discussion
The strengths of this study relate to the large and representative sample size, the measures taken to avoid contamination, and the comprehensive approach to costing and health economics. Few data were missing, partly because data were collected quarterly.
Note
contamination: 汚染。ランダム化比較試験では、対照群が介入の影響を受けることを contamination という。
Our recruitment process might have selected care homes with staff who had a particular interest in falls prevention, meaning that usual care in our control homes might have been better than usual care seen more widely—this might have been expected to reduce the size of the treatment effect and is unlikely to negate our findings.