Does prospective acceptability of an intervention influence refusal to participate in a randomised controlled trial? An interview study

Sekhon, Mandeep; Cartwright, Martin; Lawes-Wickwar, Sadie; McBain, Hayley; Ezra, Daniel G.; Newman, Stanton; Francis, Jill J

doi:10.1016/j.conctc.2021.100698

Cited by 23 publications

(21 citation statements)

References 32 publications

(35 reference statements)

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“…Feeney et al described anticipated burden as the burden of spouse caregivers who perceived their partners in severe health conditions in the future [ 19 ]. Sekhon et al studied defined anticipatory burden in a random control trial (RCT) as the accessibility of the intervention and the required amount of effort for participation [ 20 ]. Notably, in this study, the concept of anticipatory burden was utilized to determine if low accessibility is a significant factor leading to reduced participation or non-adherence to the intervention among the participants.…”

Section: Resultsmentioning

confidence: 99%

Anticipatory Burden in Adult-Child Caregivers: A Concept Analysis

She

Man

2022

Healthcare

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This study aims to analyze the concept of anticipatory burden in adult-child caregivers. A systematic literature review was performed using four databases, Pubmed, CINAHL, PsycINFO and Medline, with the keywords of “anticipatory burden” and “anticipated burden”. Simplified Wilson’s classic concept analysis modified by Walker and Avant was employed to identify the attributes, antecedents and consequences of anticipatory burden in the adult-child caregivers. Eighteen articles were analyzed. Attributes of anticipatory burden in adult-child caregivers were found to be: (1) subjective burden, (2) anticipation, (3) overestimation, (4) inability, and (5) family relationship. Antecedents were identified as: (1) potential care recipients, (2) caregiving willingness, and (3) a lack of resources. Consequences included: (1) prediction of caregiving willingness, (2) impacts on caregivers’ health, (3) intervention promotion, and (4) behavioral changes. As the adult-child caregiver is one of the main types of family caregivers for the fast-growing aging population, it is important to understand the attributes, antecedents, and consequences of their anticipatory burden. Based on the results of this study, resources such as intervention, policy, and counseling services are recommended to help adult-child caregivers lower their anticipatory burden and get better prepared for providing family care.

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Section: Resultsmentioning

confidence: 99%

Anticipatory Burden in Adult-Child Caregivers: A Concept Analysis

She

Man

2022

Healthcare

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“…Data from the study however suggests that participants were equally as confident in this new model of care as treatment as usual, and could meet the needs of over a third of patients who would prefer a shorter or longer treatment schedule than the typical 12 weeks. A more in-depth understanding of the acceptability of the new treatment model, has been further analyzed in a qualitative study and is reported elsewhere [ 33 ]. The views of healthcare professionals within the dystonia service would also be valuable to future implementation efforts and an in-depth understanding of their beliefs could be obtained from future research.…”

Section: Discussionmentioning

confidence: 99%

A patient-initiated treatment model for blepharospasm and hemifacial spasm: a randomized controlled trial

et al. 2022

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Background To test, in a two-arm, single center, superiority, randomized controlled trial, the effectiveness of and costs associated with a patient-initiated treatment model for people with hemifacial spasm (HFS) and blepharospasm (BEB) in comparison to usual care. Methods One hundred and thirty patients with HFS or BEB, aged 18 years or over, were recruited from a nurse-led botulinum toxin type A clinic at an eye hospital in the United Kingdom (UK), completed baseline measures and were randomized (1:1). The intervention group determined their own botulinum toxin type A (BoNT/A) treatment schedule during the trial period (9 months) and received an information leaflet with a “hotline” number to book an appointment. Usual care appointments were scheduled by treating clinicians. Data analysts were blind to study group. The primary outcomes were disease severity and functional disability, as measured by the Jankovic Rating Scale and Blepharospasm Disability Index, respectively. Secondary outcomes included quality of life, anxiety and depression, satisfaction with care, confidence in the service, economic costs and employment days lost. Results Sixty-five patients were randomized to each group. The intervention demonstrated no statistically significant difference to usual care for any of primary outcomes. On secondary outcomes the levels of anxiety differed significantly (F2, 142.39 = 1.65, p = 0.02), with the intervention arm exhibiting a decrease and the control arm an increase (Hedges’ g = − 0.26 [99% CI -0.83, 0.32]). No other statistically significant differences were found for secondary outcomes. Overall healthcare costs and costs to the patient were on average £198.95 less (95% CI -£256.76, £654.67; p = 0.10) per participant for those in the intervention compared to usual care, although this finding was not significant. Conclusions We did not observe differences between the patient-initiated treatment model and usual care for people with BEB or HFS, on any primary outcome measure, quality of life, or depression. The patient-initiated treatment model may, however, have the potential to save healthcare costs and reduce anxiety. Patients using this new model were also equally as satisfied in the service and confident in their care as those receiving treatment as usual. Trial registration Clinicaltrials.gov ID NCT02577224, 16th October 2015.

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“…Evaluating prospective acceptability is valuable because it can influence participation and uptake rates [ 14 ], and we recommend that this is routinely included in implementation. Only one-third of the WASH studies evaluated the prospective acceptability of the interventions; fewer still used this information to influence the design or implementation of the intervention.…”

Section: Discussionmentioning

confidence: 99%

“…The ‘acceptability’ of an intervention is a key component of implementation [ 13 ]. This is because acceptability can influence initial uptake, and sustained use of an intervention [ 14 ]. Sekhon et al recently developed the theoretical framework of acceptability (TFA) for healthcare interventions [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

Acceptability measures of water, sanitation and hygiene interventions in low- and middle-income countries, a systematic review

et al. 2022

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Background Inadequate access to water, sanitation, and hygiene (WASH) is an environmental risk factor for poor health outcomes globally, particularly for children in low- and middle-income countries (LMIC). Despite technological advancements, many interventions aimed at improving WASH access return less than optimal results on long term impact, efficacy and sustainability. Research focus in the ‘WASH sector’ has recently expanded from investigating ‘which interventions work’ to ‘how they are best implemented’. The ‘acceptability’ of an intervention is a key component of implementation that can influence initial uptake and sustained use. Acceptability assessments are increasingly common for health interventions in clinical settings. A broad scale assessment of how acceptability has been measured in the WASH sector, however, has not yet been conducted. Methods/Principal findings We conducted a systematic literature review of intervention studies published between 1990 and 2021 that evaluated the acceptability of WASH interventions in LMIC settings. Using an implementation science approach, focused outcomes included how acceptability was measured and defined, and the timing of acceptability assessment. We conducted quality assessment for all included studies using the Cochrane Risk of Bias tool for randomised studies, and the Newcastle-Ottawa Scale for non-randomised studies. Of the 1238 records; 36 studies were included for the analysis, 22 of which were non-randomized interventions and 16 randomized or cluster-randomized trials. We found that among the 36 studies, four explicitly defined their acceptability measure, and six used a behavioural framework to inform their acceptability study design. There were few acceptability evaluations in schools and healthcare facilities. While all studies reported measuring WASH acceptability, the measures were often not comparable or described. Conclusions As focus in WASH research shifts towards implementation, a consistent approach to including, defining, and measuring acceptability is needed.

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Does prospective acceptability of an intervention influence refusal to participate in a randomised controlled trial? An interview study

Cited by 23 publications

References 32 publications

Anticipatory Burden in Adult-Child Caregivers: A Concept Analysis

Anticipatory Burden in Adult-Child Caregivers: A Concept Analysis

A patient-initiated treatment model for blepharospasm and hemifacial spasm: a randomized controlled trial

Acceptability measures of water, sanitation and hygiene interventions in low- and middle-income countries, a systematic review

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