Factors associated with patient willingness to participate in anaesthesia clinical trials: a vignette-based cross-sectional study

Abstract

Background: Clinical trials are essential to improve knowledge of anesthesia and perioperative medicine. Unfortunately, many studies face participant-recruitment issues and fail to include the planned number of participants. There is limited published data about how information delivered about the study or how the experiences and attitudes of prospective participants influence willingness to participate. The purpose of this study was to identify such factors in the domain of anesthesia care. Methods: We performed a cross-sectional study at the Geneva University Hospitals (Switzerland) using a newly developed paper-based questionnaire on a sample of outpatients with a recent hospital stay and that were aged over 18 years, confident speaking French and free of any disease that could hinder participation. We explored patient personal factors, such as current health, past exposure to clinical research and anesthesia, as well as study-related factors. Six different scenarios for clinical studies were assessed. Linear regression modeling was used to assess the specific association between personal and study-related factors and willingness to participate in the studies described in the scenarios. Results: On the 1318 eligible patients, 398 fully completed the questionnaire. Multivariable adjustment revealed that factors related to altruistic values (β, 9.6, 95% CI 3.4 to 15.7, P = 0.002), to the feeling of benefiting from a more effective treatment (β, 4.7, 95% CI 0.2 to 9.2, P = 0.041) and to the absence of fear about double blinding (β, 5.7, 95% CI 1.3 to 10.2, P = 0.012) were positively associated with willingness to participate. Conversely, concerns about drug-related adverse effects (β, − 11.7, 95% CI − 16.9 to − 6.5, P < 0.001) and anxiety about surgery (β, − 5.2, 95% CI − 10.0 to − 0.5, P = 0.031) were negatively associated with willingness to participate. Conclusion: Our study was based on vignettes illustrating typical scenarios of clinical trials performed in anesthesia. However, their similarities with real studies still remains hypothetical and our results should be interpreted as such. Nevertheless, the study contributes to improve understanding of factors that may act as incentives or barriers to participation in clinical trials. It highlights the importance of providing appropriate information and reassurance to patients.

Volunteer Bias and Female Participation in Exercise and Sports Science Research

“…Females are less willing than males to participate in dental research, particularly dental surgery research, with 82.3% of females and 53.8% of males fearful of acquiring an infectious disease if they participate (Al-Amad et al, 2014). Females are also less willing than males to participate in anesthesia research (Balajonda et al, 2013;Noirmain et al, 2020) and research that involves intravenous amphetamine administration and positron emission tomography -a result mediated by sensation-seeking (Oswald et al, 2013). Notably, sensation seeking also correlates with willingness to participate in pain research (Karos et al, 2018).…”

Comparing medication adherence in patients receiving bisphosphonates for preventing fragility fractures: a comprehensive systematic review and network meta-analysis

“…These findings are partly in line with the results from the drop-out NMA at 12 months. Without ignoring the interplay of individual and contextual factors, which affect participation and adherence in clinical trials [ 28 , 29 ], we can assume that most ZOL users are likely to receive at least two infusions before discontinuing their treatment. The use of ZOL has been generally recommended for at least three years [ 30 ] and, although reduced adherence rates have been observed in ZOL users after the first year [ 31 ], simpler drug regimens can improve adherence rates [ 32 ].…”

“…[1,3,6,8,9,10,12,13,16,18,[20][21][22][23][36][37][38][39][40][41][43][44][45][48][49][50]54,55, 61,63,65]. Overall, 38 trials exclusively targeted female participants[1-3,6,8,12,13,15,16,20-24,27-30,32,33,35,37-41 ,46,47,49,55,57-59,61,64,65,67,68], while in 21 trials, most of the participants fulfilled the criteria of osteoporosis[3,6,8,12,13,15,16,20,27,28,33,37,41,42,52,57,60,61,63,64,67]. In total, the overall risk of bias was high in 18 trials[12,13,15,16,27,28,30,34,46,54,55,58,59,63-65,67,69] (Appendix 6).…”

“…Overall, 38 trials exclusively targeted female participants[1-3,6,8,12,13,15,16,20-24,27-30,32,33,35,37-41 ,46,47,49,55,57-59,61,64,65,67,68], while in 21 trials, most of the participants fulfilled the criteria of osteoporosis[3,6,8,12,13,15,16,20,27,28,33,37,41,42,52,57,60,61,63,64,67]. In total, the overall risk of bias was high in 18 trials[12,13,15,16,27,28,30,34,46,54,55,58,59,63-65,67,69] (Appendix 6). The majority of observational studies adopted a retrospective design, while three of them adopted a prospectivecomparative design [88,98,99].…”

Specifics of motivation of volunteers participating in in a clinical trial of the COVID-19 vaccine

“…Однако мотивация пациентов к участию или неучастию в КИ по-прежнему является очень важным социологическим вопросом, требующим более детального изучения [11,12]. Так, по данным исследования, проводимого в Соединённом Королевстве, только 31 % КИ, одобренных комитетами по этике, завершили набор участников вовремя и с запланированным количеством [13]. Готовность пациентов участвовать в КИ зависит от нескольких факторов, в том числе от ожидаемой пользы, понимания пациентом процедур КИ и уровня доверия пациентов к исследователям [11,14].…”