Serious adverse events of older adults in nursing home and community intervention trials

Datta, Rupak; Trentalange, Mark; Ness, Peter H. Van; McGloin, Joanne M.; Guralnik, Jack M.; Miller, Michael E.; Walkup, Michael P.; Nadkarni, Neelesh K.; Pahor, Marco; Gill, Thomas M.; Quagliarello, Vincent; Juthani‐Mehta, Manisha

doi:10.1016/j.conctc.2017.12.004

Cited by 8 publications

(5 citation statements)

References 20 publications

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“…Recording all AEs is time-consuming, particularly in populations with a high frequency of AEs. SAE reporting in an older adult trial of cranberry juice capsules was estimated to have taken 15 hours per week each for two research nurses, yet none of the SAEs recorded were considered related to the trial intervention or unexpected [84] . Similarly, a review of substance abuse clinical trials evaluating psychosocial interventions found all serious AEs were unrelated to the study interventions [85] .…”

Section: Discussionmentioning

confidence: 99%

Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions

Papaioannou

Cooper

Mooney

et al. 2021

Journal of Clinical Epidemiology

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Section: Discussionmentioning

confidence: 99%

Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions

Papaioannou

Cooper

Mooney

et al. 2021

Journal of Clinical Epidemiology

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“…Most residents of nursing homes not only have cognitive or functional restrictions caused by chronic progressive diseases but also have more comorbid diseases compared to community-dwelling seniors who function well 4 , 5 . In addition, they may be at high-risk of being exposed to infectious disease outbreaks due to their grouped living conditions 6 . Therefore, nursing home residents have specific and demanding healthcare, management and treatment needs that require appropriate nursing 4 , 5 .…”

Section: Introductionmentioning

confidence: 99%

Effects of registered nurse staffing levels, work environment, and education levels on adverse events in nursing homes

Choi

Cho

Kim

et al. 2021

Sci Rep

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This study examined the effects of nurse staffing levels, work environment, and education levels on adverse events in nursing homes. A cross-sectional study was conducted involving 216 nurses working in 62 nursing homes in South Korea, using self-reported questionnaires and data from the National Health Insurance Service of South Korea. A logistic regression model was used to investigate the effects of nurse staffing levels, work environment, and nursing education levels on the adverse events experienced by residents. An increase of one resident per nurse was significantly associated with a higher incidence of medication error, pressure ulcers and urinary tract infections. A poor work environment increased the incidence of adverse events. Compared to nurses with a bachelor’s degree or higher, those with diplomas reported increased incidence rates of pressure ulcers. Improving the health outcomes of residents in nursing homes requires efforts that strengthen the nursing workforce in terms of numbers and educational level, and which improve their work environment at institutional and policy levels.

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“…Others have commented on the burden of recording harms in non-drug trials. In particular, where medical events are frequent in trial populations and unlikely to be caused by a behaviour change intervention, trialists and trial participants have spent large amounts of time recording unrelated harmful events ultimately irrelevant to the intervention evaluation [ 7 , 8 ]. Assessment of causality of harms on an individual event level, i.e.…”

Section: Discussionmentioning

confidence: 99%

“…Trials may use a huge amount of resource and staff time in recording obviously irrelevant harms (not related to the intervention). This can be particularly pertinent in populations that experience a high frequency of harms, such as older adults [ 7 ] or those frequently hospitalised, e.g. substance abuse [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators

Papaioannou,

Sprange,

Hamer-Kiwacz

et al. 2024

Trials

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Background Harms, also known as adverse events (AEs), are recorded and monitored in randomised controlled trials (RCTs) to ensure participants’ safety. Harms are recorded poorly or inconsistently in RCTs of Behaviour Change Interventions (BCI); however, limited guidance exists on how to record harms in BCI trials. This qualitative study explored experiences and perspectives from multi-disciplinary trial experts on recording harms in BCI trials. Methods Data were collected through fifteen in-depth semi-structured qualitative interviews and three focus groups with thirty-two participants who work in the delivery and oversight of clinical trials. Participants included multi-disciplinary staff from eight CTUs, Chief investigators, and patient and public representatives. Interviews and focus group recordings were transcribed verbatim and thematic analysis was used to analyse the transcripts. Results Five themes were identified, namely perception and understanding of harm, proportionate reporting and plausibility, the need for a multi-disciplinary approach, language of BCI harms and complex harms for complex interventions. Participants strongly believed harms should be recorded in BCI trials; however, making decisions on “how and what to record as harms” was difficult. Recording irrelevant harms placed a high burden on trial staff and participants, drained trial resources and was perceived as for little purpose. Participants believed proportionate recording was required that focused on events with a strong plausible link to the intervention. Multi-disciplinary trial team input was essential for identifying and collecting harms; however, this was difficult in practice due to lack of knowledge on harms from BCIs, lack of input or difference in opinion. The medical language of harms was recognised as a poor fit for BCI trial harms but was familiar and established within internal processes. Future guidance on this topic would be welcomed and could include summarised literature. Conclusions Recording harms or adverse events in behaviour change intervention trials is complex and challenging; multi-disciplinary experts in trial design and implementation welcome forthcoming guidance on this topic. Issues include the high burden of recording irrelevant harms and use of definitions originally designed for drug trials. Proportionate recording of harms focused on events with a strong plausible link to the intervention and multi-disciplinary team input into decision making are essential.

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Serious adverse events of older adults in nursing home and community intervention trials

Cited by 8 publications

References 20 publications

Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions

Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions

Effects of registered nurse staffing levels, work environment, and education levels on adverse events in nursing homes

Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators

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