Methodological issues1 | Findings | Evidence |
---|---|---|
1. Sample size calculation | Completed using the outcome variable of gingival bleeding | The expected difference in mean percentage gingival bleeding between intervention and control was 9 (SD intervention group 31: SD control group 32). The power calculation for these figures at 80% with a two-sided alpha at 5% indicates a total sample size of 400. |
2. Eligibility | Achieved: 10% eligible of women for inclusion; all antenatal clinical and administrative staff eligible | In the first 2 weeks of the study, a total of 300 pregnant women attended the clinic of whom 10% met the inclusion criteria. 15 women were approached in week 1 and a further 10 in week 2. All women approached agreed to participate. Four clinical and administrative staff were approached and all agreed to participate. |
3. Recruitment | Recruitment was successful with all participants agreeing to participate | The antenatal clinic staff were very enthusiastic as their previous experience with dental health services had been positive. They felt that that dental health service should be re-instated. |
4. Consent | All participants provided informed and written consent | After being provided with the PIS, all participants, after a cooling-off period, agreed to participate in the TIPPS intervention and provided informed and written consent. |
7. Adherence to the intervention | The adherence to the intervention was good. | TIPPS intervention appointments attended: baseline: n = 25; Time 1: n = 14 (56%); Time 2: 22 (88%). The TIPPS training day was attended by all of the nurses, and administrative staff attended the day’s training workshop; enjoyed learning about TIPPS and implementing it in accordance with the TIPPS intervention protocol. |
8. Intervention acceptability | The TIPPS intervention was acceptable but ambivalence over who should deliver it in the clinic | All of the women and the clinic staff felt that the TIPPS intervention was an excellent idea which should be extended throughout pregnancy. The clinic staff felt that others should implement it and not nursing staff. Concerns about staff time and cost of nurses’ time and expertise to deliver TIPPS. |
9. Intervention costs and duration | Intervention costs were calculated and duration time of the total intervention known. | Costs of toothbrushes, toothpastes, and interdental cleaning together with TIPPS information materials. The total length of time of the intervention including follow-up appointments was 3 months. |
10. Completion of the outcome assessments | Outcome assessments were completed | Assessed by the quality of the data: only 12% of data were missing from the outcomes variable, gingival bleeding and 22% from infant birth weight |
11. Appropriateness of the outcomes measured | The measures used to assess the primary and secondary outcomes assessed issues of concern | Change in plaque and bleeding scores were measured. Completed infant birth weight will be secured on the birth of the child. |
12. Retention | Retention was good for mothers at baseline and at Time 2 but not Time 1; retention for clinic and administrative staff was good | See point 7: the conflict affected 3 participants attendance at Time 2. |
13. Logistics of running a feasibility study in a LMIC in an area of conflict | The recruitment went well due to XX’s specialist knowledge and interactions with the clinic staff; difficulties in transporting dental supplies to Gaza city experienced | 25 women, 2 antenatal nurses, and 2 administrative staff recruited. Dental supplies were delivered to the clinic following intervention with CDOs in Palestine and Israel. |
14. Synergy between all components of the protocol | All elements of the study worked well together | The elements of the study flowed well from one part to the next. Knowledge obtained informative for a full trial. |