Folayan Morenike Oluwatoyin, Alade Micheal O, Oziegbe Elizabeth O
Department of Child Dental Health, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria.
BMC Res Notes. 2019 Aug 7;12(1):493. doi: 10.1186/s13104-019-4500-0.
The aim of the study was to identify reasons for protocol deviations during conduct of large epidemiological surveys despite training of field workers, validating clinicians, and providing field supervisory support. Enquiries focused on breaches of recruitment procedures, privacy, confidentiality, and informed consent. The case study was a household survey conducted in Ile-Ife, Nigeria.
The study reveals that despite training of field workers, providing supervisory support, and conducting validation exercises, protocol deviation still occurred. Measures to improve internal research validity during the conduct of surveys can minimise but not eliminate protocol deviations. Individual and environmental factors increase the risk for protocol deviation. Individual factors include personal bias against adherence to elements of the protocols, and pressure to meet personal recruitment targets to maximise remuneration. These pressures increase the risk of breaching study participants' recruitment process. Environmental pressures resulted from low research literacy that made it possible for field workers not to consent participants and for participants not to prioritise privacy. The use of electronic data collection enhanced data security. A key recommendation from the study was that improved field supervision will reduce the risk for protocol violation.
本研究的目的是确定在进行大型流行病学调查过程中，尽管对现场工作人员进行了培训、对临床医生进行了验证并提供了现场监督支持，但仍出现方案偏离的原因。调查重点是违反招募程序、隐私、保密和知情同意的情况。该案例研究是在尼日利亚伊费进行的一项家庭调查。
研究表明，尽管对现场工作人员进行了培训、提供了监督支持并进行了验证工作，但方案偏离仍有发生。在调查过程中提高内部研究效度的措施可以将方案偏离降至最低，但无法消除。个人因素和环境因素会增加方案偏离的风险。个人因素包括对遵守方案要素的个人偏见，以及为了最大化薪酬而达到个人招募目标的压力。这些压力增加了违反研究参与者招募流程的风险。环境压力源于研究素养较低，这使得现场工作人员有可能不征得参与者同意，且参与者也不将隐私视为优先事项。使用电子数据收集提高了数据安全性。该研究的一项关键建议是，加强现场监督将降低违规风险。
