Abstract：
OBJECTIVE: The embedded Qualitative Process Evaluation (QPE) within the CSTICH- Pilot RCT explored facilitators and barriers to recruitment within the Pilot. This study reports a secondary analysis of the overarching theme of Fluidity of Equipoise and the influences on individual and community clinical equipoise around the use of Emergency Cervical Cerclage (ECC).
METHODS: RCT recruitment assumes clinical equipoise and is defined as genuine uncertainty about an intervention. The ability of trial recruiters to convey this equipoise is also key to participant recruitment and fully informed consent. This exploratory qualitative process evaluation used semi-structured interviews with healthcare professionals (HCPs) involved in trial recruitment. Interviews were audio-recorded, transcribed, and analysed using codebook thematic analysis.
RESULTS: 23 HCPs were interviewed. Clinical equipoise around the use of ECC was variable and influenced by a multitude of factors including: (1) obstetric history; (2) gestation; (3) standard site practice, and (4) HCPs previous experiences of ECC. We have interpreted this variability as \'fluidity of equipoise\'.
CONCLUSIONS: Clinical equipoise around complex pregnancy related conditions was fluid and influenced by the complexities of obstetric histories and gestation at presentation. Equipoise of HCPs involved in trial recruitment should be considered carefully as it can impact the nuances of recruitment, particularly in more challenging trials such as CSTICH-2. Study-specific documents and training can be used to increase staff and patient awareness of uncertainty in the evidence base for interventions under investigation. Further research is needed around the potential consequences of equipoise fluidity.
METHODS: RCT recruitment assumes clinical equipoise and is defined as genuine uncertainty about an intervention. The ability of trial recruiters to convey this equipoise is also key to participant recruitment and fully informed consent. This exploratory qualitative process evaluation used semi-structured interviews with healthcare professionals (HCPs) involved in trial recruitment. Interviews were audio-recorded, transcribed, and analysed using codebook thematic analysis.
RESULTS: 23 HCPs were interviewed. Clinical equipoise around the use of ECC was variable and influenced by a multitude of factors including: (1) obstetric history; (2) gestation; (3) standard site practice, and (4) HCPs previous experiences of ECC. We have interpreted this variability as \'fluidity of equipoise\'.
CONCLUSIONS: Clinical equipoise around complex pregnancy related conditions was fluid and influenced by the complexities of obstetric histories and gestation at presentation. Equipoise of HCPs involved in trial recruitment should be considered carefully as it can impact the nuances of recruitment, particularly in more challenging trials such as CSTICH-2. Study-specific documents and training can be used to increase staff and patient awareness of uncertainty in the evidence base for interventions under investigation. Further research is needed around the potential consequences of equipoise fluidity.
摘要：
目的：CSTICH-PilotRCT中的嵌入式定性过程评估（QPE）探索了飞行员中招募的促进者和障碍。这项研究报告了对等效流动性的总体主题以及使用紧急宫颈环扎术（ECC）对个人和社区临床等效性的影响的二次分析。
方法：RCT招募假定临床平衡，并定义为对干预的真正不确定性。试验招募人员传达这种平衡的能力也是参与者招募和充分知情同意的关键。这种探索性定性过程评估使用了参与试验招募的医疗保健专业人员（HCP）的半结构化访谈。采访是录音的，转录，并使用码本专题分析法进行分析。
结果：对23位HCP进行了访谈。使用ECC的临床平衡是可变的，并受多种因素的影响，包括：（1）产科病史；（2）妊娠；（3）标准现场实践，(4)HCP以往的ECC经验。我们将这种可变性解释为“平衡的流动性”。
结论：复杂的妊娠相关疾病的临床平衡是不稳定的，并受到产科病史和妊娠的复杂性的影响。应仔细考虑参与试验招募的HCP的均衡，因为它会影响招募的细微差别，特别是在更具挑战性的试验中，如CSTICH-2。特定于研究的文件和培训可用于提高工作人员和患者对正在调查的干预措施的证据基础中的不确定性的认识。需要围绕平衡流动性的潜在后果进行进一步研究。
方法：RCT招募假定临床平衡，并定义为对干预的真正不确定性。试验招募人员传达这种平衡的能力也是参与者招募和充分知情同意的关键。这种探索性定性过程评估使用了参与试验招募的医疗保健专业人员（HCP）的半结构化访谈。采访是录音的，转录，并使用码本专题分析法进行分析。
结果：对23位HCP进行了访谈。使用ECC的临床平衡是可变的，并受多种因素的影响，包括：（1）产科病史；（2）妊娠；（3）标准现场实践，(4)HCP以往的ECC经验。我们将这种可变性解释为“平衡的流动性”。
结论：复杂的妊娠相关疾病的临床平衡是不稳定的，并受到产科病史和妊娠的复杂性的影响。应仔细考虑参与试验招募的HCP的均衡，因为它会影响招募的细微差别，特别是在更具挑战性的试验中，如CSTICH-2。特定于研究的文件和培训可用于提高工作人员和患者对正在调查的干预措施的证据基础中的不确定性的认识。需要围绕平衡流动性的潜在后果进行进一步研究。
