Abuhaloob Lamis, Helles Nahla, Mossey Peter, Freeman Ruth
Dental School and Hospital, University of Dundee, Park Place, Dundee, Scotland, DD1 4HN, UK.
Ministry of Health, Gaza Strip and West Bank, Palestine.
Pilot Feasibility Stud. 2021 Apr 1;7(1):91. doi: 10.1186/s40814-021-00827-x.
A feasibility study was conducted to implement the Talk, Instruct, Practice, Plan and Support (TIPPS) intervention for pregnant women to enhance infant birth weight in a conflict area in Low- and Middle-Income Countries (LMIC). The decision tool, A process for Decision-making after Pilot and feasibility Trials (ADePT), examines the methodological factors identified in a feasibility study, that may require modification for a full trial. Thus, this study aimed to use the ADePT decision tool to evaluate if the feasibility study had achieved its objectives and to identify the need for intervention, clinical context and trial design modification.
A one-arm, pretest-posttest feasibility study recruited 25 pregnant women in their first trimester and clinic staff from a primary healthcare clinic located in Gaza City, Palestine. The TIPPS periodontal health intervention was delivered by antenatal care nurses to the pregnant women during their regular follow-up appointments. The ADePT framework was applied to evaluate the findings from the feasibility study. The ADePT checklist demonstrated sample size estimation, recruitment, consent, intervention adherence, intervention acceptability, costs and duration, completion and appropriateness of outcome assessments, retention, logistics, and synergy between protocol components.
All recruited pregnant women (25, aged 16-35 years old) consented to participate in the study, and the adherence to the intervention was 88% (22 women). The TIPPS intervention was acceptable, but there was ambivalence over who should deliver it in the clinic. Only the cost of toothbrushing and TIPPS information materials was calculated, while the cost of nurses' time was not included. The missing values of data were few (12% of gingival bleeding data and 22% from infant birth weight data). This intervention significantly reduced the mean percentage of plaque and bleeding scores after 3 months. The sample size for future randomised controlled trial was estimated around 400 participants. The participants stated the value of the intervention. The clinic staff voiced concerns regarding time and the cost of nurses providing the TIPPS intervention. This allowed suggestions to be made regarding the modification of trial design and context of implementation.
The ADePT evaluation showed it was possible to progress to full trial with modifications in the trial design.
开展了一项可行性研究，对低收入和中等收入国家（LMIC）冲突地区的孕妇实施“谈话、指导、实践、计划与支持”（TIPPS）干预措施，以提高婴儿出生体重。决策工具“试点和可行性试验后的决策过程”（ADePT）审视可行性研究中确定的方法学因素，这些因素可能需要在全面试验中进行修改。因此，本研究旨在使用ADePT决策工具评估可行性研究是否实现其目标，并确定干预措施、临床背景和试验设计修改的必要性。
一项单组、前后测可行性研究招募了25名孕早期孕妇以及来自巴勒斯坦加沙城一家初级保健诊所的临床工作人员。TIPPS牙周健康干预措施由产前护理护士在孕妇定期随访预约期间提供给她们。应用ADePT框架评估可行性研究的结果。ADePT清单展示了样本量估计、招募、同意、干预依从性、干预可接受性、成本和持续时间、结局评估的完成情况和适当性、保留率、后勤保障以及方案各组成部分之间的协同作用。
所有招募的孕妇（25名，年龄在16至35岁之间）均同意参与研究，干预措施的依从率为88%（22名女性）。TIPPS干预措施是可接受的，但对于在诊所应由谁来实施该干预存在矛盾态度。仅计算了牙刷和TIPPS信息材料的成本，未包括护士的时间成本。数据缺失值较少（牙龈出血数据的12%以及婴儿出生体重数据的22%）。该干预措施在3个月后显著降低了菌斑和出血评分的平均百分比。未来随机对照试验的样本量估计约为400名参与者。参与者阐述了该干预措施的价值。临床工作人员对护士提供TIPPS干预措施的时间和成本表示担忧。这使得能够就试验设计和实施背景的修改提出建议。
ADePT评估表明，对试验设计进行修改后有可能开展全面试验。
