COMMENTARY

Commentaries on Ierfino et al. (2015) REWARDING SMOKING CESSATION IN PREGNANCY-WILL WOMEN CHEAT TO GAIN INCENTIVES? There is a growing body of research that suggests that financial incentives can encourage health behaviour change, but they remain controversial [1]. Some of the most consistently positive evidence is for incentives for smoking cessation in pregnancy, where a recent Cochrane Review found incentives to be the most effective intervention [2]. This is to address a harmful health behaviour that is challenging for women to change, and where some approaches that seem to work with other adult smokers have not yet been shown to be effective. The Cochrane Review contained just four small trials conducted in the United States, involving approximately 1200 women. More evidence is needed, particularly in countries such as the United Kingdom, where national targets to reduce smoking in pregnancy have not been met [3]. Ierfino and colleagues test incentives in a ‘real world’ setting, offering them alongside existing smoking cessation services in one part of England [4]. They found reasonable levels of uptake; most women who signed up to the programme made a quit attempt and 8% were validated as abstinent from smoking at delivery. This is a similar proportion of women who stopped smoking by the end of pregnancy in one recent trial of nicotine replacement therapy (NRT) [5] and higher than a second, similar trial of NRT [6]. Unlike some previous studies of incentives for cessation in pregnancy, women in this study were eligible to continue receiving incentives during the postpartum period. Half of those recorded as non-smokers at delivery were not using tobacco at 6 months after the birth, a similar rate of relapse to that observed in population surveys of pregnant smokers who are not engaged in cessation programmes [7,8]. This suggests that incentives did not reduce relapse rates significantly, although the numbers here are very small. Perhaps the key contribution of this study, however, particularly given the authors’ acknowledgement of the limitations of the research design (observational data which cannot tell us a great deal about efficacy) is the careful assessment of ‘gaming’. That participants will cheat to enter or remain in incentive schemes is a common conception. It is cited frequently as a reason not to support incentives for health behaviour change. Ierfino and colleagues found that no women pretended to be smokers to enter the scheme. Voluntarily taking up or restarting smoking to a level that can be detected seems unlikely © 2015 Society for the Study of Addiction

in pregnancy. Some evidence of cheating during the programme was detected, perhaps once women identified the limitations (smoking in the past day) of the carbon monoxide (CO) breath test. However, here the numbers were still low—with 4% of women (10 participants) managing to ‘game’ the CO breath test. These women were identified when the more robust biochemical validation measure of salivary cotinine was used. Widespread cheating was not observed. This is consistent with the findings of qualitative research, with women and health professionals involved in another recent study of incentives for cessation in pregnancy that we have just completed in Glasgow [9,10]. In our study there were also few reports of gaming. Instead, interviewees emphasized the importance of behavioural support for smoking cessation alongside incentives that was part of our programme, as it was in the Ierfino study. Stopping smoking in pregnancy is not easy for many women [11], and support and trust—rather than blame and questioning—needs to be a part of any cessation programme. The Ierfino study adds to existing evidence that suggests rewarding women for engaging with smoking cessation programmes and for maintaining a quit attempt is a promising strategy. Further research is needed to confirm efficacy in a UK context. A greater challenge may be to address policy makers and public scepticism about such schemes, but monitoring and reporting on gaming can contribute to that. Declaration of interests None. Keywords Gaming, incentives, nicotine replacement therapy, pregnancy, relapse, smoking cessation. LINDA BAULD & LESLEY SINCLAIR University of Stirling E-mail: [email protected]

References 1. Aveyard P., Bauld L. Incentives for promoting smoking cessation: what we still do not know. Cochrane Lib 2011; 13: 8. 2. Lumley J., Chamberlain C., Dowswell T., Oliver S., Oakley L., Watson L. Interventions for promoting smoking cessation during pregnancy. Cochrane Database Syst Rev 2009. doi: 10.1002/14651858.CD001055.pub3. 3. Action on Smoking and Health (ASH). Smoking Cessation in Pregnancy: A Call to Action. London: Action on Smoking and Health; 2013. Available at: http://www.ash.org.uk/files/documents/ASH_893.pdf (accessed 23 December 2014) Addiction, 110, 689–692

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4. Ierfino D., Mantzari E., Hirst J., Jones T., Aveyard P., Marteau T. Financial incentives for smoking cessation in pregnancy: a single-arm intervention study assessing cessation and gaming. Addiction 2015: 110: 680–8. 5. Coleman T., Cooper S., Thornton J. G., Grainge M. J., Watts K., Britton J. et al. A randomized trial of nicotine-replacement therapy patches in pregnancy. N Engl J Med 2012: 366: 808–18. 6. Berlin I., Grangé G., Jacob N., Tanguy M. L. Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy. BMJ 2014; 348: g1622. 7. McBride C. M., Pirie P. L. Postpartum smoking relapse. Addict Behav 2000; 15: 165–8. 8. Carmichael, S. L., Ahluwalia, I. B. Correlates of postpartum smoking relapse: results from the Pregnancy Risk Assessment Monitoring System (PRAMS). Am J Prev Med 2000; 19: 193–6. 9. Tappin D. M., Bauld L., Tannahill C., de Caestecker L., Radley A., McConnachie A. et al. The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomised controlled trial. Trials 2012; 13: 113. 10. Tappin D., Bauld L., Sinclair L., Boyd K., McKell J., Macaskill S. et al. Financial incentives for smoking cessation in pregnancy: randomised controlled trial. BMJ 2015. doi: 10.1136/bmj. h134. 11. Flemming K., Graham H., Heirs M., Fox D., Sowden A. Smoking in pregnancy: a systematic review of qualitative research of women who commence pregnancy as smokers. J Adv Nurs 2013; 69: 1023–36.

CONTINUING EFFORTS TO IMPROVE CESSATION OUTCOMES WITH PREGNANT CIGARETTE SMOKERS We are pleased to have this opportunity to comment on the excellent report by Ierfino and colleagues [1]. We begin by underscoring that smoking during pregnancy is the leading preventable cause of poor pregnancy outcomes in developed countries, also increasing the risk for numerous adverse neonatal outcomes, including sudden infant death and childhood behavior problems, as well as risk for later-in-life metabolic disorder and other chronic diseases [2–4]. The 0% cessation rate among the historical controls in the Ierfino et al. report provides a useful context for considering how urgent is the need for improvements in the effectiveness of strategies for managing this serious public health problem. It appears that the historical controls in this trial were offered the opportunity to receive individual cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT). Results from a highly influential meta-analysis of interventions for smoking cessation among pregnant women, including CBT and NRT, indicates that they produce an approximately 6% increase above control levels in late-pregnancy abstinence rates [5]. Therefore, perhaps the 0% outcome may not conform perfectly to © 2015 Society for the Study of Addiction

expectations, but is not inaccurate by a great deal. It is important to note that such lackluster outcomes in routine care for pregnant smokers are not novel, especially among more disadvantaged women. Ierfino and colleagues supplemented routine care with an intervention using voucherbased financial incentives in the present effectiveness trial, which according to the same meta-analysis is expected to increase abstinence rates by approximately 24% above control levels. Ierfino et al. achieved a 20% late-pregnancy abstinence rate which, again, is somewhat, although not greatly, below predicted outcomes. These differences from predicted outcomes are probably attributable to the relatively high levels of socio-economic disadvantage among the women treated, which Ierfino and colleagues demonstrated predict poor outcomes with this incentives intervention. We have reported the same in our own research with the same incentives model, as well as a control intervention [6]. With both the historical controls and incentives intervention it appears that the outcomes obtained by Ierfino and colleagues are reasonable representations of how these interventions perform among economically disadvantaged pregnant smokers. In our opinion, the adverse impacts of smoking during pregnancy are too serious and well documented to accept 0% when it could be 20% unless there is good reason for doing so. This report by Ierfino and colleagues addressed one of the major rationales against adopting this incentives model: the intervention is too complex and timeconsuming to integrate into routine obstetrical care. To the contrary, Ierfino and colleagues demonstrated that the intervention can be implemented effectively within the obstetrical service of a large hospital by adding only the additional support of the smoking-cessation staff person that the Community Health Service already provides. This is an enormously important contribution. There are seven controlled clinical trials supporting the efficacy of this voucher-based financial incentives model for smoking cessation among pregnant and newly postpartum pregnant women [7-13], along with evidence that the intervention increases fetal growth and improves birth outcomes [11,12,14] increases breastfeeding duration [15] and decreases postpartum depressive symptoms among depression-prone women who are at increased risk for postpartum depression [16]. Rather than making assumptions about the feasibility of moving this promising model into routine care we should test the assumptions empirically, as was performed in this study. We commend Ierfino and colleagues for keeping the parameters of the intervention largely consistent with those used in the efficacy trials, especially maximum potential incentive earnings. In this effectiveness trial, those incentives were extended to 24 weeks postpartum whereas in the efficacy trials they were terminated after 8-12 weeks postpartum. There were other minor procedural differences Addiction, 110, 689–692

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(e.g.how abstinence was biochemically confirmed) that do not merit detailing here and are to be expected. What we can say unequivocally, however, is that when we have had discussions with our local health department officials about such an effectiveness trial they have not been nearly as sensitive to the importance of maintaining the integrity of the intervention tested in the efficacy trials. Indeed, the suggested changes to the intervention in those initial discussions were sufficiently concerning to us to silence further discussion. We now plan to re-open those discussions with the Ierfino et al. report in hand. Our health department also assigns a smoking-cessation specialist to each regional hospital, so the staffing model used by Ierfino and colleagues appears to have potential for broad generalizability. Also important to note is that when we strip away the considerable research elements of our prior four trials on this incentives model, the actual clinical intervention duties have been handled almost exclusively by a primary interventionist, so our experience on this staffing point is consistent with that outlined by Ierfino and colleagues. Another benefit of keeping the effectiveness model close to the efficacy trials is that it creates the opportunity for meaningful comparisons and scientific dialogue between the efficacy and effectiveness investigators. In addition to the agreement noted above regarding socio-economic status as a predictor, we have also tested the predictive utility of delay discounting of hypothetical monetary rewards and similarly failed to find a significant association with cessation outcomes [17]. We have observed significant associations between discounting and spontaneous quitting after learning of a pregnancy, although these were conditional on smoking rate (i.e. significant negative association among light but not heavier smokers) [18]. This brings us to our final point regarding predictors. Ierfino and colleagues report no significant association between nicotine dependence level and treatment response, using the Heaviness of Smoking Questionnaire to assess nicotine dependence [19]. This instrument assesses time to first cigarette after awakening in the morning and number of cigarettes smoked per day, using an algorithm to combine across those two measures to arrive at a single score. Cigarettes smoked per day has been a robust, reliable predictor of antepartum abstinence levels achieved with this incentives model in our predictor studies [6,17]. We encourage Ierfino and colleagues to examine whether the same is also true in their data set if cigarettes/day is looked at separately. We close on the topic of cost-effectiveness, which Ierfino and colleagues mention appropriately as an important next step in the evaluation of this incentives model. We agree, and currently have such a trial under way comparing usual care alone versus usual care plus this incentives model through 1-year postpartum examining smoking status and maternal and infant health outcomes. © 2015 Society for the Study of Addiction

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Ierfino and colleagues appear to be well positioned to conduct a similar trial in their setting. Should that happen, we look forward to the opportunity to learn from each other. We note an irony in both groups concurring on the importance of this next step in trying to disseminate this incentives model into routine care. Where are those cost-effectiveness trials for the interventions currently being offered as routine care to pregnant smokers in the host hospital for this effectiveness trial or in our home community hospital? Indeed, where are the efficacy trials showing that NRT reduces smoking among pregnant smokers? Food for thought. We commend Ierfino and colleagues on an excellent study and report. Declaration of interests None. Acknowledgements The authors acknowledge the support of Center of Biomedical Research Excellence Center Award P20GM103644 and research grant R01HD075669 from the National Institute on General Medical Sciences and National Institute of Child Health and Human Development, respectively. Keywords Contingency management, financial incentives, pregnancy, smoking cessation, vouchers. STEPHEN T. HIGGINS1,2 & SARAH H. HEIL1,2

Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA1 and University of Vermont, Departments of Psychiatry and Psychology2 E-mail: [email protected]

References 1. Ierfino D., Mantzari E., Hirst J., Jones T., Aveyard P., Marteau T. Financial incentives for smoking cessation in pregnancy: a single-arm intervention study assessing cessation and gaming. Addiction 2015: 110: 680–8. 2. Cnattingius S. The epidemiology of smoking during pregnancy: smoking prevalence, maternal characteristics, and pregnancy outcomes. Nicotine Tob Res 2004; 6: S125–40. 3. Dietz P. M., England L. J., Shapiro-Mendoza C. K., Tong V. T., Farr S. L., Callaghan W. M. Infant morbidity and mortality attributable to prenatal smoking in the U.S. Am J Prev Med 2010; 39: 45–52. 4. Bakker H., Jaddoe V. W. V. Cardiovascular and metabolic influences of fetal smoke exposure. Eur J Epidemiol 2011; 26: 763–70. 5. Lumley J., Chamberlain C., Dowswell T., Oliver S., Oakley L., Watson L. Interventions for promoting smoking cessation during pregnancy. Cochrane Database Syst Rev 2009, CD001055 (8 July). Addiction, 110, 689–692

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6. Higgins S. T., Heil S. H., Badger G. J., Skelly J. M., Solomon L. J., Bernstein I. M. Educational disadvantage and cigarette smoking during pregnancy. Drug Alcohol Depend 2009; 104: S100–5. 7. Donatelle R. J., Prows S. L., Champeau D., Hudson D. Randomized controlled trial using social support and financial incentives for high risk pregnant smokers: significant other support (SOS) program. Tob Control 2000; 9: iii67–9. 8. Donatelle R. J., Prows S. L., Champeau D., Hudson D. Using social support, biochemical feedback, and incentives to motivate smoking cessation during pregnancy: comparison of three intervention trials. Poster Presented at the Annual Meeting of the American Public Health Association, Boston, MA; 2000. 9. Donatelle R., Hudson D., Dobie S., Goodall A., Hunsberger M., Oswald K. Incentives in smoking cessation: status of the field and implications for research and practice with pregnant smokers. Nicotine Tob Res 2004; 6: S163–79. 10. Higgins S. T., Heil S. H., Solomon L., Bernstein I. M., Lussier J. P., Abel R. L. et al. A pilot study on voucher-based incentives to promote abstinence from cigarette smoking during pregnancy and postpartum. Nicotine Tob Res 2004; 6: 1015–20. 11. Heil S. H., Higgins S. T., Bernstein I. M., Solomon L. J., Rogers R. E., Thomas C. S. et al. Effects of voucher-based incentives on abstinence from cigarette smoking and fetal growth among pregnant women. Addiction 2008; 103: 1009–18. 12. Higgins S., Bernstein I. M., Washio Y., Heil S. H., Badger G. J., Skelly J. M. et al. Effects of smoking cessation with voucher-

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based contingency management on birth outcomes. Addiction 2010; 105: 2023–30. Higgins T. M., Higgins S. T., Heil S. H., Badger G. J., Skelly J. M., Bernstein I. M. et al. Effects of cigarette smoking cessation on breastfeeding duration. Nicotine Tob Res 2010; 12: 483–8. Higgins S. T., Washio Y., Heil S. H., Solomon L. J., Gaalema D. E., Higgins T. M. et al. Financial incentives for smoking cessation among pregnant and newly postpartum women. Prev Med 2012; 55: S33–40. Higgins S. T., Washio Y., Lopez A. A., Heil S. H., Solomon L. J., Lynch M. E. et al. Examining two different schedules of financial incentives for smoking cessation among pregnant women. Prev Med 2014; 68: 51–7. Lopez A. A., Skelly J. M., Higgins S. T. Financial incentives for smoking cessation among depression-prone pregnant and newly postpartum women: effects on smoking abstinence and depression ratings. Nicotine Tob Res, in press. Lopez A. A., Skelly J. M., White T. J., Higgins S. T. Does impulsiveness moderate response to financial incentives for smoking cessation among pregnant and newly postpartum women? Exp Clin Psychopharmacol, in review. White T. J., Redner R., Skelly J. M., Higgins S. T. Examining educational attainment, prepregnancy smoking rate, and delay discounting as predictors of spontaneous quitting among pregnant smokers. Exp Clin Psychopharmacol 2014; 22: 384–91. Kozlowski L. T., Porter C. Q., Orleans T., Pope M. A., Heatherton T. Predicting smoking cessation with self-reported measures of nicotine dependence: FTQ, FTND, and HSI. Drug Alcohol Depend 1994; 34: 211–6.

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Rewarding smoking cessation in pregnancy-will women cheat to gain incentives?

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