Measuring implementation fidelity in a cluster-randomized pragmatic trial: development and use of a quantitative multi-component approach.
Measuring implementation fidelity in a cluster-randomized pragmatic trial: development and use of a quantitative multi-component approach.
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在群集随机务实试验中测量实施保真度：开发和使用定量多组分方法。
DOI：
10.1186/s13063-022-06002-8
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发表时间：
2022-01-15
期刊：
影响因子：
2.5
通讯作者：
Rudolph JL
中科院分区：
文献类型：
--
作者：
Olson MB;McCreedy EM;Baier RR;Shield RR;Zediker EE;Uth R;Thomas KS;Mor V;Gutman R;Rudolph JL
在务实的试验中，现场合作伙伴，而不是研究人员，导致干预交付，这可能会导致实施的变化。需要定量地测量这种变化。应用框架的实现保真度（FIF），我们开发了一种方法来衡量网站级的实现保真度的变化。然后，这种方法被应用到测量站点级保真度的集群随机务实试验的音乐和记忆SM（M&M），个性化的音乐干预，针对激动的行为，在居民生活与痴呆症，在美国养老院（NH）。干预NH（N = 27）实施M&M使用标准化手册，利用提供的工作人员培训和iPod的参与居民。定量实施数据，包括iPod元数据（即，歌曲名称、持续时间、播放次数），在基线、4个月和8个月的现场访问期间收集。三名研究人员开发了四个FIF坚持维度分数。就内容详情而言，我们独立审阅实施手册，并就六个核心M&M组成部分达成共识。覆盖率是每个NH接触音乐的居民总数。频率是每个NH中至少每周暴露于M&M的参与居民的百分比。持续时间是每个居民每天接触音乐的平均分钟数。对数据元素进行缩放和求和，以生成维度级别的NH评分，然后将其求和以创建复合依从性评分。NH按三分位数（低、中、高保真度）分组。这27个国家卫生机构在规模、居民构成和公开报告的质量评级方面各不相同。综合评分显示NH之间存在显著差异，范围为4.0 - 12.0 [8.0，标准差（SD）2.1]。量表维度得分与综合得分显著相关。然而，维度得分彼此之间的相关性并不高;例如，内容细节得分与覆盖率的相关性为τB = 0.11（p = 0.59），与持续时间的相关性为τB =-0.05（p = 0.78）。综合评分与CMS质量星星评级和阿尔茨海默氏症单位的存在相关，表明表面有效性。在FIF的指导下，我们开发并使用了一种方法来定量测量多站点务实试验中的整体站点级保真度。未来的务实试验，特别是在长期护理环境中，可能会受益于这种方法。Clinicaltrials.gov NCT03821844。于2019年1月30日注册，https://clinicaltrials.gov/ct2/show/NCT03821844。在线版本包含补充材料，可通过10.1186/s13063-022-06002-8获得。
In pragmatic trials, on-site partners, rather than researchers, lead intervention delivery, which may result in implementation variation. There is a need to quantitatively measure this variation. Applying the Framework for Implementation Fidelity (FIF), we develop an approach for measuring variability in site-level implementation fidelity. This approach is then applied to measure site-level fidelity in a cluster-randomized pragmatic trial of Music & MemorySM (M&M), a personalized music intervention targeting agitated behaviors in residents living with dementia, in US nursing homes (NHs). Intervention NHs (N = 27) implemented M&M using a standardized manual, utilizing provided staff trainings and iPods for participating residents. Quantitative implementation data, including iPod metadata (i.e., song title, duration, number of plays), were collected during baseline, 4-month, and 8-month site visits. Three researchers developed four FIF adherence dimension scores. For Details of Content, we independently reviewed the implementation manual and reached consensus on six core M&M components. Coverage was the total number of residents exposed to the music at each NH. Frequency was the percent of participating residents in each NH exposed to M&M at least weekly. Duration was the median minutes of music received per resident day exposed. Data elements were scaled and summed to generate dimension-level NH scores, which were then summed to create a Composite adherence score. NHs were grouped by tercile (low-, medium-, high-fidelity). The 27 NHs differed in size, resident composition, and publicly reported quality rating. The Composite score demonstrated significant variation across NHs, ranging from 4.0 to 12.0 [8.0, standard deviation (SD) 2.1]. Scaled dimension scores were significantly correlated with the Composite score. However, dimension scores were not highly correlated with each other; for example, the correlation of the Details of Content score with Coverage was τb = 0.11 (p = 0.59) and with Duration was τb = − 0.05 (p = 0.78). The Composite score correlated with CMS quality star rating and presence of an Alzheimer’s unit, suggesting face validity. Guided by the FIF, we developed and used an approach to quantitatively measure overall site-level fidelity in a multi-site pragmatic trial. Future pragmatic trials, particularly in the long-term care environment, may benefit from this approach. Clinicaltrials.gov NCT03821844. Registered on 30 January 2019, https://clinicaltrials.gov/ct2/show/NCT03821844. The online version contains supplementary material available at 10.1186/s13063-022-06002-8.
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DOI：
10.1016/j.jamda.2020.01.103
发表时间：
2020-08
影响因子：
7.6
作者：
Bakerjian D;Bettega K;Cachu AM;Azzis L;Taylor S
通讯作者：
Taylor S
影响因子：
3.5
作者：
Elliott, DS;Mihalic, S
通讯作者：
Mihalic, S
影响因子：
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作者：
Inouye, SK;Bogardus, ST;Agostini, JV
通讯作者：
Agostini, JV
影响因子：
39
作者：
Mitchell, Susan L.;Volandes, Angelo E.;Mor, Vincent
通讯作者：
Mor, Vincent
DOI：
10.1093/gerona/54.11.m546
发表时间：
1999-11-01
影响因子：
5.1
作者：
Morris, JN;Fries, BE;Morris, SA
通讯作者：
Morris, SA