Lamis Abuhaloob1, Nahla Helles2, Peter Mossey3, Ruth Freeman3. 1. Dental School and Hospital, University of Dundee, Park Place, Dundee, Scotland, DD1 4HN, UK. lamis.abu_haloob@yahoo.co.uk. 2. Ministry of Health, Gaza Strip and West Bank, Palestine. 3. Dental School and Hospital, University of Dundee, Park Place, Dundee, Scotland, DD1 4HN, UK.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: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. CONCLUSIONS: The ADePT evaluation showed it was possible to progress to full trial with modifications in the trial design.
RCT Entities:
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: The ADePT evaluation showed it was possible to progress to full trial with modifications in the trial design.
Authors: Maartje M van den Berg; Ali Khader; Majed Hababeh; Wafa'a Zeidan; Silvia Pivetta; Mariam Abd El-Kader; Ghada Al-Jadba; Akihiro Seita Journal: PLoS One Date: 2018-06-13 Impact factor: 3.240
Authors: Collette Kirwan; Lisa Hynes; Nigel Hart; Sarah Mulligan; Claire Leathem; Laura McQuillan; Marina Maxwell; Emma Carr; Kevin Roche; Scott Walkin; Caroline McCarthy; Colin Bradley; Molly Byrne; Susan M Smith; Carmel Hughes; Maura Corry; Patricia M Kearney; Geraldine McCarthy; Margaret Cupples; Paddy Gillespie; Anna Hobbins; John Newell; Liam Glynn; Davood Roshan; Carol Sinnott; Andrew W Murphy Journal: Pilot Feasibility Stud Date: 2022-10-04