Abstract
Background:
Under-recruitment in clinical trials has become a worldwide problem, and has many causes that need to be understood. Clinical Research Nurses (CRNs) provide a new research perspective.
Aim:
To understand the current situation about the informed consent rate after the participation of CRNs and analyse the possible influencing factors.
Methods:
This cross-sectional study was conducted at a hospital. A convenience sample was used to study patients with pulmonary nodules who underwent day surgery from March to May 2023. Patients first received information from doctors and a second session by CRNs was provided for those who initially were hesitant about the research. A questionnaire survey was conducted using an online survey platform to collect information.
Results:
After education by doctors, 208 patients were hesitant and CRNs conducted a second education session, the CICARE model was used for communication. Following this session a further 161 patients were willing to participate. Finally, 374 patients were willing to participate. Related factors include age, education level and the attitude of self-assessed family members towards their participation in clinical projects.
Conclusions:
CRNs’ participation can improve patients’ willingness to participate. It is crucial to pay attention to the role of CRNs and propose a new model of CRNs involvement in clinical research based on identifying factors.
Keywords: clinical research nurses, medical research hospital, patient participation, pulmonary nodule patients
Introduction
According to the 2020 Global Cancer Statistics Analysis Report, lung cancer is the second most common cancer globally, with 2,206,771 new cases and 1,796,144 deaths (Sung et al., 2021). Early screening for lung cancer has prompted many patients classified as high-risk to undergo low-dose computed tomography, dramatically increasing the number of patients referred for treatment of new pulmonary nodules (Choi and Mazzone, 2022; Wood et al., 2018). Pulmonary nodules refer to lung lesions with a diameter of less than or equal to 3 cm, opaque images, clear borders, and are surrounded by air-containing lung tissue. Lung lesions such as atelectasis, hilar lymphadenopathy, and pleural effusion are excluded (Mazzone and Lam, 2022). Pulmonary nodules can easily progress to lung cancer, which has the highest incidence and mortality among all malignant tumours in China (Yang et al., 2020), affecting people’s lives and health. The emergence of precision medicine has brought about a turnaround in the diagnosis and treatment of lung cancer, but realising precision medicine requires medical workers or researchers to pay attention to the bioinformatic data of clinical samples and analyse the cause of the disease and related treatment targets to predict the disease’s occurrence, development, and outcome (Vargas and Harris, 2016; Liu and Ye, 2021).
Since the representativeness of lung cancer clinical research results needs to be considered (Kilic et al., 2023), it is necessary to recruit a sufficient number of patients to participate in clinical research. However, under-recruitment in clinical trials has become a worldwide problem, and when the number of patients enrolled is less than the expected estimated sample size, the study results and reliability of clinical trials are often affected (Ueda et al., 2021). Patient informed consent and willingness to participate ensure that clinical research, such as sample collection, can proceed smoothly. However, in actual clinical research, the smooth acquisition of informed consent is restricted by many factors (Ginossar et al., 2022; Li et al., 2021), challenging the recruitment of subjects. According to existing literature, factors influencing patients’ willingness to participate in clinical trials can be explored from the following aspects: communication between researchers and family members, patient disease history, preference for alternative treatments, treatment convenience, and accessibility to medical insurance (Arnetz et al., 2019). Jin et al. (2020) conducted a systematic review of relevant factors that affect individuals’ attitudes toward participating in medical research and analysed 63 documents. The results demonstrated that patient factors (such as gender and age, education level, socioeconomic factors, racial differences, altruism, health status), research factors (such as research type, economic benefits, access to treatment, medical research participation experience) could predict individuals’ attitudes towards participating in medical research.
As of 20 September 2023, the total number of annual clinical trials registered on platforms (Center for Drug Evaluation, 2023) in China was 21,735, with the vigorous development of clinical trials. Especially affected by the novel coronavirus pneumonia epidemic, the total number of clinical trials in China increased during this period, allowing more researchers to participate in clinical research (Tinkler et al., 2018). Clinical Research Nurses (CRN) as a professional group has a development history of more than 40 years in Europe and the United States, but it is in its infancy in China (Wu and Li, 2022). Clinical Research Nursing, as defined by the International Association of Clinical Research Nurses (International Association of Clinical Research Nurses, 2016), is a specialised form of professional nursing that maintains a balance between caring for research participants and adhering to the research protocol. This practice involves ensuring the protection of human subjects, coordinating and providing continuous care, contributing to clinical science, managing clinical practice and facilitating learning across different professional roles, practice settings, and clinical specialties.
General nurses provide care for all patients, whereas CRNs mainly provide care for clinical research subjects (Hao et al., 2022). CRNs play multiple roles in clinical trials, such as educators, advocates, collaborators, data collectors, and liaisons (Hernon et al., 2020). The work of CRNs involves all aspects of clinical trials, for instance, before the trial is officially started, CRNs need to needs to prepare for the trial, establish close contact with the ethics committee, conduct recruitment and screening of subjects, and obtain informed consent from subjects; during the official start of the trial, CRNs should assist the researchers in conducting the various work of the trial, such as visiting, consulting, and negotiating with patients and their families; after the trial is completed, CRNs are responsible for education, data collection, timely transcription of case report forms, management of clinical examinations, adverse events and documentation. This work is conducive to promoting the ethical rationality of clinical trials, standardised scientific processes, and the reliability of trial data. It is worth noting that informed consent spans through the entire process of clinical research. CRNs are responsible for maintaining ethical conduct and complying with the principle of informed consent (Godskesen et al., 2023), to enhance participant safety and advocacy (Hansen et al., 2022).
Due to the advancement of lung cancer diagnosis and treatment as well as implementation of the lung cancer screening programme in China (Cheng et al., 2019), the number of patients with pulmonary nodules is gradually increasing, but recruiting patients and obtaining informed consent from patients in clinical research is still an important issue. Patients’ access to sufficient information and trust in researchers are essential prerequisites for clinical trial participation (Karampatakis et al., 2021). It has been reported that dedicated research nurses are necessary for successful patient recruitment into clinical trials (Brown et al., 2019). However, Clinical Research Nursing is an emerging profession in China. Although relevant studies have investigated patients’ willingness to participate in clinical trials, less attention has been paid to whether patients are willing to donate blood specimens for clincial experimental research, and the functional role played by CRNs is less involved. Based on the literature review, this study intends to explore the relevant influencing factors on patients’ participation in clinical research, and understand the current situation about the informed consent rate after the participation of CRNs. By introducing a new model of CRN involvement in clinical research, the results of the present study could emphasise the important role of CRNs in clinical research to improve patients’ willingness to participate. Promoting the integration of medical practice and medical research accelerates the construction and development of research oriented-hospitals.
Methods
From March 28 to May 18, 2023, we enrolled 475 patients with pulmonary nodules who underwent day surgery on the same day in the thoracic department at a comprehensive tertiary hospital in China. This formed a convenience sample. The inclusion criteria were: (1) those with chest CT report showing lung shadows; (2) to be at least 18 years old; (3) informed consent and voluntary participation in this study; (4) having normal communication skills, able to complete the questionnaire by themselves or with the assistance of the researcher. The exclusion criteria were: (1) with severe mental disorders and cognitive impairment; (2) with severe complications that affect the respondent; (3) those with a history of malignant tumours; (4) to participate in other clinical research projects.
Based on the sample size calculation formula, N = p × (1–p)×(z/d)2, with a confidence interval set at 95% and a Z value of 1.96, where d represents the allowable error specified as 0.05. We conducted a preliminary investigation and found that the patient participation rate in preoperative blood collection willingness represent 50.0%. Therefore, the sample size is N = 385 at least.
Instruments
To collect sample characteristics, we manually crafted a questionnaire and divided it into two distinct sections. The first section includes patient demographic information, such as age, gender, place of residence, educational level, marital status, occupational status and economic conditions. The second section delves into clinical research-related aspects, including patients’ overall impression of medical staff, degree of interest in health programmes, and their self-evaluation of their family members’ support for their participation in clinical projects.
Data collection procedure
First, thoracic surgeons introduced blood drawing clinical research to the patients including that the purpose of a 5ml blood sample was mainly to assist in the diagnosis of benign and malignant pulmonary nodules, asked the patients to fill in the questionnaire about the basic information, with the researcher assisting. Data were collected via the online survey platform (Wenjuanxing, http://www.wjx.cn), allowing patients to independently respond by scanning a researcher-provided quick response (QR) code. Trained interviewers administered questionnaires individually to those unable to respond manually, following the questionnaire’s original intent. To improve online questionnaire efficiency, interviewers gave a uniform introduction on purpose, significance, and completion instructions at the start. All questions were required, and each device allowed only one response submission.
Then, patients who were hesitant about blood drawing clinical research were referred by doctors to full-time CRNs in the hospital, and the CICARE model was used for communication (University of California, Los Angeles General Hospital). It was divided into six processes of ‘connect-introduce-communicate-ask-respond-exit’ (Wen et al., 2012). CRNs used the CICARE model to conduct a second conversation, as shown in Table 1.
Table 1.
CRNs conversation content based on CICARE communication model.
| Communication elements | The specific conversation contents of CRNs |
|---|---|
| Contact | CRNs dressed appropriately, greeted patients patiently and fully understood the basic information as well as medical records of patients with pulmonary nodules referred by doctors. |
| Introduction | CRNs proactively introduced basic information and identity to the patient, informed the patient of the purpose of communication, observed the patient’s expression and body movements, and then communicated in detail after receiving the patient’s approval. |
| Communicate | CRNs communicated with patients in a warm and positive attitude, understood the patients’ concerns about participating in blood drawing, guided patients to proactively express their true inner emotions, and used professional clincial knowledge to solve confusions patiently. |
| Ask | CRNs took the initiative to ask patients about their understanding of the blood drawing project and whether they still had any worries about participating in research projects. |
| Respond | CRNs patiently answered various questions raised by patients, choosing different answer methods for patients with different personalities, and tried to use easy-to-understand language to make patients understand the issues related to research projects. |
| Exit | CRNs had a clear understanding of the patient’s intention after detailed communication between the nurse and the patient, thanked the patient for cooperation and greeted the patient off politely with a smile. |
CRN: Clinical Research Nurse.
Data analysis
In this study, the original data from the online survey were analysed using SPSS statistics v25.0 (IBM Inc., Armonk, NY, USA). Two researchers double-checked the imported data. Descriptive statistics are expressed as frequencies and percentages, the measurement data is represented as mean ± SD, and the t-test analysis was adopted between the samples. Chi-square tests were used to compare data between multiple groups using the Bonferroni method after correcting test levels. In this study, p < 0.05 is regarded as a statistical significance level with two-tailed.
Ethical considerations
All patients were invited to participate voluntarily in the study, and informed consent was obtained from all patients included in this study. The data were collected in accordance with the Code of Ethics of the Declaration of Helsinki (World Medical Association, 2013). Patient participation was entirely voluntary and confidential. The investigation was approved by the Institutional Review Board of the hospital (No. ID: 2022-1109).
Results
Baseline characteristics
A total of 475 questionnaires were distributed in this study, and 421 patients were finally included. After explanation by the researcher, patients were willing to complete the questionnaire, but the study excluded 54 patients (11.37%) who did not complete the blood drawing due to objective reasons, of which 46 (85.19%) patients were unable to collect blood because they had been sent for surgery, 5 (9.26%) patients had their operations cancelled, 2 patients (3.70%) were unable to have blood drawn due to infusion status, and 1 patient (1.85%) failed blood drawing, so the questionnaires of the group of patients were not included in the analysis. The mean age of 421 respondents was 54.27 years old (SD = 12.61), with 34.20% male and 65.80% female. The characteristics of respondents (N = 421) are presented in Table 2.
Table 2.
Participants demographics and univariate analysis affecting patients’ participation in blood collection for clinical trials.
| Variables | Total number (%, n = 421) | Refuse (%, n = 47) | Agree (%, = 374) | χ 2 | p Value |
|---|---|---|---|---|---|
| Age (year) | 9.506 | 0.008 | |||
| 18–34 | 43 (10.21) | 10 (23.26) | 33 (76.74) | ||
| 35–49 | 81 (19.24) | 4 (4.94) | 77 (95.06) | ||
| ⩾50 | 297 (70.55) | 33 (11.11) | 264 (88.89) | ||
| Gender | 0.091 | 0.763 | |||
| Male | 144 (34.20) | 17 (11.81) | 127 (88.19) | ||
| Female | 277 (65.80) | 30 (10.83) | 247 (89.17) | ||
| Residency | 1.460 | 0.227 | |||
| Urban area | 163 (38.72) | 22 (13.50) | 141 (86.50) | ||
| Rural area | 258 (61.82) | 25 (9.69) | 233 (90.31) | ||
| Education level | 6.302 | 0.012 | |||
| Below undergraduate | 350 (83.14) | 33 (9.03) | 317 (90.57) | ||
| Bachelor degree or above | 71 (16.86) | 14 (19.72) | 57 (80.28) | ||
| Working status | 2.681 | 0.262 | |||
| Unemployed | 50 (11.88) | 9 (18.00) | 41 (82.00) | ||
| Employed | 222 (52.73) | 23 (10.36) | 199 (89.64) | ||
| Retired | 149 (35.39) | 15 (10.07) | 134 (89.93) | ||
| Marital status | 0.051 | 0.309 | |||
| Have partner | 377 (89.55) | 40 (10.61) | 337 (89.39) | ||
| No partner | 44 (10.45) | 7 (15.91) | 37 (84.09) | ||
| Overall impression of medical staff | 0.031 | 0.190 | |||
| Good | 375 (89.07) | 40 (10.67) | 335 (89.33) | ||
| Better | 44 (10.45) | 6 (13.64) | 3 8 (86.36) | ||
| Moderate | 2 (0.48) | 1 (50.00) | 1 (50.00) | ||
| Degree of interest in health programmes | 0.990 | 0.610 | |||
| Often | 180 (42.76) | 22 (12.22) | 158 (87.78) | ||
| Occasionally | 221 (52.49) | 24 (10.86) | 197 (89.14) | ||
| Never | 2 0 (4.75) | 1 (5.00) | 1 9 (95.00) | ||
| Economic conditions | 2.002 | 0.368 | |||
| Poverty | 30 (7.13) | 1 (3.33) | 29 (96.67) | ||
| Moderate | 299 (71.02) | 35 (11.71) | 264 (88.29) | ||
| Good | 92 (21.85) | 11 (11.96) | 81 (88.04) | ||
| Self-evaluation of family members’ attitudes | 23.896 | <0.001 | |||
| Positive | 370 (87.89) | 31 (8.38) | 339 (91.62) | ||
| Negative | 51 (12.11) | 16 (31.37) | 35 (68.63) | ||
Univariate analysis for predictors of patient participation rate
The patient participation rate in preoperative clinical research blood collection was 88.84% (374/421). Univariate analysis revealed statistical differences in age (χ2 = 9.506, p = 0.008), education level (χ2 = 6.302, p = 0.012), and perceived a supportive attitude of family members (χ2 = 23.896, p < 0.001), compared with patients who agreed to blood drawing and those who refused, as shown in Table 2.
Impact of CRNs on patients’ clinical research participation
In this study, 89.07% of patients had a good impression of the medical staff, it is necessary to further explore the impact of CRNs on patients’ willingness to participate in clinical research. CRNs conducted a second conversation with patients who were hesitant to participate in clinical research after the doctor’s conversation, thereby analysing the factors that influence the patient’s willingness to participate in blood collection for clinical research, as shown in Table 3. Consistent with the mentioned results, there were statistical differences between patients in terms of age, education level and family support (p < 0.05).
Table 3.
The impact of CRN on patients’ willingness to participate in blood collection in clinical trials.
| Variables | Total number (%, n = 208) | Refuse (%, n = 47) | Agree (%, n = 161) | χ 2 | p Value |
|---|---|---|---|---|---|
| Age (year) | 7.302 | 0.026 | |||
| 18–34 | 24 (11.54) | 10 (41.67) | 14 (58.33) | ||
| 35–49 | 34 (16.35) | 4 (11.76) | 30 (88.24) | ||
| ⩾50 | 150 (72.12) | 33 (22.00) | 117 (78.00) | ||
| Gender | 0.031 | 0.861 | |||
| Male | 73 (35.10) | 17 (23.29) | 56 (76.71) | ||
| Female | 135 (64.90) | 30 (22.22) | 105 (77.78) | ||
| Residency | 3.230 | 0.072 | |||
| Urban area | 75 (36.06) | 22 (29.33) | 53 (70.67) | ||
| Rural area | 133 (63.94) | 25 (18.80) | 108 (81.20) | ||
| Education level | 10.606 | 0.001 | |||
| Below undergraduate | 177 (85.10) | 33 (18.64) | 144 (81.36) | ||
| Bachelor degree or above | 31 (14.90) | 14 (45.16) | 17 (54.84) | ||
| Working status | 2.4 62 | 0.292 | |||
| Unemployed | 26 (12.50) | 9 (34.62) | 17 (65.38) | ||
| Employed | 1 09 (52.40) | 2 3 (21.10) | 8 6 (78.90) | ||
| Retired | 7 3 ( 35.10) | 1 5 (20.55) | 5 8 (79.45) | ||
| Marital status | 0.474 | 0.491 | |||
| Have partner | 183 (87.98) | 40 (21.86) | 143 (78.14) | ||
| No partner | 25 (12.02) | 7 (28.00) | 143 (78.14) | ||
| Overall impression of medical staff | 0.069 | 0.594 | |||
| Good | 1 80 (86.54) | 4 0 (22.22) | 1 40 (77.78) | ||
| Better | 2 6 (12.50) | 6 (23.08) | 2 0 (76.92) | ||
| Moderate | 2 (0.96) | 1 (50.00) | 1 (50.00) | ||
| Degree of interest in health programmes | 0.313 | 0.855 | |||
| Often | 9 4 (45.19) | 22 (23.40) | 72 (76.60) | ||
| Occasionally | 1 07 (51.44) | 2 4 (22.43) | 8 3 (77.57) | ||
| Never | 7 (3.37) | 1 (14.29) | 6 (85.71) | ||
| Economic conditions | 2.613 | 0.271 | |||
| Poverty | 14 (6.73) | 1 (7.14) | 13 (92.86) | ||
| Moderate | 155 (74.52) | 35 (22.58) | 120 (77.42) | ||
| Good | 39 (18.75) | 11 (28.21) | 28 (71.79) | ||
| Self-evaluation of family members’ attitudes | 10.970 | <0.001 | |||
| Positive | 171 (82.21) | 31 (18.13) | 140 (81.87) | ||
| Negative | 37 (17.79) | 16 (43.24) | 21 (56.76) | ||
CRN: Clinical Research Nurse.
Although the CRNs’ conversation success rate (conversation success rate = CRNs’ conversation success rate/total conversation success rate × 100%) was 43.05% (161/374), which was slightly lower than the doctors’ conversation success rate (56.95%, 213/374), the difficulty of the conversation was escalated for patients who initially were hesitant to participate in clinical research. With the efforts of CRNs, the final patient willingness rate to participate in blood collection in preoperative clinical research increased from 50.60% (213/421) to 88.84% (374/421), and CRNs recovery conversation agreement rate (recovery conversation agreement rate = number of successful CRNs conversations/number of patients who initially were hesitant to participate in clinical research × 100%) reached 77.40% (161/208).
Discussion
Sample collection is an important part of clinical research. Compared with urine and faces, blood is the most informative biological sample for researchers in early clinical trials of drugs (Bai et al., 2022). It is also necessary for the samples to be collected for each type of early-stage clinical research. In the present study, the final preoperative clinical research blood drawing for patients with pulmonary nodules was 88.84%, which is higher than the results of previous studies (Unger et al., 2021) on tumour patients. This higher participation rate may be due to the innovative invitation of CRNs for timely intervention in the present study. On the other hand, with the vigorous development of clinical research in China, the effective popularisation of relevant knowledge, the transparency of clinical research design and implementation has also driven more and more patients to change their role as ‘guinea pigs’ in the past. Stereotypes and resistance to clinical research are no longer the norm.
Patient recruitment issues are the primary reason for delays in clinical trials (Brogger-Mikkelsen et al., 2020). It is crucial to understand the relevant factors that affect subject participation in clinical trials, which help researchers improve recruitment methods and trial design. In this study, age and education level were the main influencing factors, similar to previous studies (Thomas et al., 2022). Compared with patients aged 18–34 years old, the blood collection participation rate of patients aged 35–49 years old was relatively higher, which may be because patients in the prime of life have rich experience and can accept clinical research in a more active state, whereas young patients’ information acquisition channels are wide and easily affected by external environmental factors. There are great concerns about the subsequent whereabouts, transfer, and use of biological samples collected. Compared with patients with a bachelor’s degree or above, patients with an education level below a bachelor’s degree are more willing to participate in blood collection for clinical research, consistent with previous research (Zhou et al., 2022). Patients with a high level of education can learn about clinical research from various sources and think and process research critically, so this group would not completely follow the doctor’s treatment decisions. Although age and education level are immutable objective factors, they also remind medical workers to pay attention to the patient’s family information and provide personalised education and guidance.
Our findings suggest that family members’ support for clinical research also affects patients’ participation rates in clinical trial blood collection (Gouveia et al., 2022). In China, whether to participate in clinical research may also be affected by patients’ family members. In particular, the average age of the patients in this study was 54.27 ± 12.61 years old. It is easy to consider the opinions and suggestions of their family members when they participate in decision-making. According to a previous study (Jiang et al., 2023), family encouragement and support can eliminate patients’ fear and worry. In the present study, CRNs performed a secondary intervention on patients with pulmonary nodules who were hesitant to participate in blood collection for clinical research, and 17.79% of patients had a negative evaluation of their perception and understanding of family support. It is inferred that CRNs can actively mobilise the patient’s social network during conversation and communication, increase the publicity of clinical research to family members, promptly solve the confusion of subjects and family members by using CICARE communication model, to obtain opinions, understanding and support on this blood drawing project from the perspective of patients and families.
Patients perceive inadequate clinical trial information as an important factor preventing them from participating in trials (Shneerson et al., 2013). This study found that the consent rate of CRNs recovery conversation agreement rate was 77.40%. CRNs’ participation can improve patients’ willingness, the following possible reasons include: first, one of the important tasks of CRNs is to collect biological samples for clinical research, and some CRNs also undertake centrifugation, freezing, storage, and transportation of biological samples (Veal et al., 2017). CRNs were more familiar with the collection environment, site, time, collection volume, and container involved in the collection of biological samples; in addition, obtaining informed consent from subjects is the primary task among duties of CRNs (Mackle and Nelson, 2019), the ethical responsibilities of CRNs require them to perform informed consent procedures during the interview process to ensure that the subjects can understand the purpose and significance of the clinical examination (Lonn et al., 2022), in this study, CRNs used the CICARE communication model to dispel patients’ worries, good communication and coordination skills help CRNs quickly establish trusting relationships with subjects. As the group members with the most contact with subjects, CRNs can better protect the rights and interests of patients by advocating for them during patient consultation, balancing patient care needs with programme requirements, case management, care coordination and patient safety (McCabe et al., 2019).
Research-oriented hospitals are the future development direction and trend of hospitals, and CRNs can play an important role in clinical research. The Management Guidelines for CRNs (Ge et al., 2023) point out that the professional qualities that CRNs should possess include communication and coordination abilities, planning organisation and management abilities, educational abilities, critical thinking, independence spirit, the ability to continue learning, and teamwork spirit. This study proposes a new model for CRNs to enable them to intervene to encourage patients to participate in preoperative blood collection clinical research. As key members of the team involved in subject recruitment and clinical research (Beer et al., 2022), by CICARE communication model, CRNs utilised their communication and education capabilities in the practice of the second preoperative dialogue, advocated medical and nursing cooperation, and used easy-to-understand language to inform patients about the purpose of this clinical research. This study found that CRNs can establish a full trust relationship with patients based on the ethical principles of respect, benefit, non-harm, fairness and assist patients in participating in clinical research, significantly improving their willingness to accept blood collection.
Limitations of the study
This study also has several limitations; First, because it involves the second conversation, the proportion of patients agreeing to participate in clinical research increases, but it is not really comparing medical doctors’ consent success with CRNs’ consent success, this study mainly aims to promote the model of CRN participating in clinical research, in order to improve patients’ willingness to cooperate and promote research-oriented hospital development, in addition, it only conducted a single-centre survey around one hospital, which limits the generalisability of the research. Multi-centre, large-sample clinical studies should be conducted in the future. Second, the measurement indicators involved in this study are in the form of self-report questionnaires, which may have subjective bias. Third, the sample may be underrepresented and can only be generalised to patients with pulmonary nodules who are able to use the Internet to participate in the survey.
Conclusions
This study found that age, education level, and the positive attitude of family members towards the research affect the choice of patients with pulmonary nodules for preoperative blood collection of clinical research. When conducting clinical research, preoperative conversations can focus on the synergy between doctors and CRNs to increase patient participation and promote the development of research-oriented hospitals.
Key points for policy, practice and/or research.
CRNs performed a secondary intervention on patients who were hesitant to participate in blood collection for clinical research, the final patient willingness rate to participate in blood collection increased from 50.60% to 88.84%.
Age, education level and the attitude of self-assessed family members were the main predictors.
The health education capabilities of CRNs can be used in clinical research. CRNs can use the CICARE communication model for patients who are hesitant to participate in clinical research to improve treatment decisions, understand and accept clinical research.
CRNs’ participation can improve patients’ willingness to participate, such as to have tests, e.g. bloods drawn, which indicates the importance of nurses in scientific research.
Acknowledgments
The authors thank the patients and nurses who contributed their time to this study. The authors also would like to thank Home for Researchers editorial team (www.home-for-researchers.com) for language editing service.
Biography
Huadi Yuan is working as a head nurse in the day surgery department of the Second Affiliated Hospital of Zhejiang University Medical College.
Meijuan Lan (MSN) is working as a director of the nursing department in the Second Affiliated Hospital of Zhejiang University Medical College.
Hong He is working as a head nurse in thoracic surgery at the Second Affiliated Hospital of Zhejiang University Medical College.
Pinghua Hong is a nurse-in-charge, working in the day surgery department of the Second Affiliated Hospital of Zhejiang University Medical College.
Liyan Gao (MSN) is working in the day surgery department of the Second Affiliated Hospital of Zhejiang University Medical College.
Footnotes
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was supported by Zhejiang Provincial Department of Education Project (Y202249448) and Zhejiang Provincial Department of Health Project (2023ZDXK-09-01).
Ethical approval: The study was approved by the Institutional Review Board of the second affiliated hospital of Zhejiang University School of Medicine (No. ID: 2022-1109).
ORCID iD: Liyan Gao 
https://orcid.org/0000-0001-9007-3825
Contributor Information
Huadi Yuan, Head Nurse, Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang, China.
Meijuan Lan, Director, Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang, China.
Hong He, Head Nurse, Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang, China.
Pinghua Hong, Nurse-in-Charge, Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang, China.
Liyan Gao, Nurse, Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang, China.
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