4. Discussion
EVENTS, RECRUITMENT, RECRUITMENT
This analysis of BENIT outcomes revealed strong self-reported intervention effects at the 22-day post-baseline assessment. Participant self-reports of 38.6% cessation for those in the intervention condition versus 9.1% cessation for those in the control condition met the Stage 3 criteria for early termination of the trial. This finding suggests that intensive cessation programs such as BENIT should be further developed and implemented in larger populations. Although the results of the current study are robust, several limitations should be noted. Bio-verification results for BENIT have been reported in a separate publication [The results presented are ‘per protocol’ and did not include 29 participants (14 for control and 15 for intervention) who withdrew from the study prior to the 22-day assessment. Had these 29 cases been included (and counted as failures to quit), cessation rates would have been 33.0% for intervention (34 out of 103) compared to 7.8% (8 out of 102) for control. Randomization did not result in balanced arms for all potentially relevant variables. Specifically, several substantial differences in baseline characteristics were observed between intervention and control condition participants, particularly with regard to sex and age, though controlling for these variables did not affect the significance of the results. These differences were likely due to the allowance for groups to be randomized together. Further, the study involved many logistical and scheduling challenges (e.g., scheduling conflicts, postponements, and weather events). Recruitment was on a rolling basis and involved word-of-mouth effects (i.e., non-random effects). Thus, controlling for imbalances between intervention and control conditions needed to be accomplished statistically.Recruiting participants for BENIT was challenging. There were several reasons for this. First, the populations of BQ chewers in Guam and Saipan are limited because the populations of these islands are not large. Second, the study was limited to those who wanted to quit (among other inclusion criteria). Third, participation in BENIT required a substantial commitment of time and energy on the part of participants (five in-person sessions). Fourth, our modest budget and research team limited the time we could spend on recruitment.We acknowledge that we were not able to accomplish all of our original objectives as described in Paulino et al. [Despite these limitations, it appears that the rationale for BENIT is supported and that a cessation program focused on ANBQ chewers who want to quit holds great potential for ANBQ chewers in Guam and Saipan, and possibly other countries in the western Pacific and other regions where ANBQ consumption is high. The results suggest that additional studies of intensive ANBQ cessation interventions are warranted. ANBQ cessation research should be expanded in many directions. Future developments should include: (1) continued refinement of biomarkers; (2) development of pharmaceutical adjuvants (similar to those used for tobacco cessation); and (3) additional treatment modalities such as electronic adjuvants for ANBQ cessation (for example, mobile applications).Mehrtash et al. [