Re: Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: randomised controlled trial
We are writing in response to the study by Ferguson et al. in the British Medical Journal  reporting negative results for the addition of nicotine replacement therapy (NRT) and comprehensive counseling to an English national telephone quitline. The study was well done and we agree with the discussion and stated limitations. However, we are concerned that some commentary and coverage is suggesting that this study repudiates the effectiveness of telephone quitlines and medications in any setting. This is far too broad a conclusion.
Ferguson and colleagues replicated features of our large randomized trial involving over 4600 adult US quitline callers . In this NIH-funded study we tested three levels of telephone quitline counseling (one 15 minute call; two counseling calls; five counseling calls) with and without eight weeks of NRT patches. We found that offering free NRT and multisession telephone counseling led to higher quit rates, and similar costs per incremental quit, compared to less intensive counseling.
Ferguson and colleagues found no differences in cessation outcomes, proposing that the lack of effectiveness may be due to 1) the similarity between standard and proactive counseling, 2) the high level of use of non – trial counseling and medication in those randomized to the no medication offer condition.
Ferguson and colleagues noted that the social context for their study differed in that cessation services and medications were already widely available and integrated into the National Health Services (NHS) in the UK, at little or no cost. The UK’s robust NHS cessation services were taken advantage of at high rates by participants in their trial. It is vitally important to stress that these findings have not been demonstrated to generalize to other quitlines in other countries such as the US which does not have universally free integrated access to cessation medication and counseling.
There are additional differences between our two studies that also may have contributed to the null findings. These differences include:
1) In our trial, eligible participants received eight weeks of NRT via direct mail, in two shipments without calling or visiting a pharmacy. Ferguson et al. provided a renewable voucher for three weeks of medication, and participants then had to call a National pharmacy to receive their medications.
2) Rates of medication use were higher in our trial; 90% take rate with 80% receiving the 1st 5-week shipment and 25-28% receiving the 2nd 3-week shipment. Ferguson et al. found that fewer than 43% reported receiving any study medications.
3) Our counseling protocol included a truly brief arm: one brief 15 min counseling (standard) vs two counseling vs five proactive calls. Their briefer counseling protocol was still multi-session.
4) Actual delivery of counseling differed significantly between conditions in our study, with those randomized to the multi-call protocol receiving 2.9 calls versus 1.0 for brief. Ferguson et al. were unable to deliver different levels of counseling.
5) In our study, counselors received training on how to encourage adherence, including management of minor side-effects and emphasis on use of full course of medication. It is unclear if this was done in the Ferguson et al. trial.
6) We did not recruit any smokers under the age of 18. Ferguson et al. included smokers aged 16-18. NRT cessation studies with youth have not found it to be effective.
7) The Ferguson et al. trial appears to have had much more dramatic fall-off in participation at different recruitment points, increasing the chance for selection bias. That is, less than 2% of all callers were randomized in their trial, while almost 20% of all callers in ours were randomized. Furthermore, in their trial less than half of those eligible agreed to participate, while in ours three out of four agreed to participate.
Randomized trials have routinely demonstrated the effectiveness and cost-effectiveness of adding adjunctive pharmacotherapies to quitline counseling [3, 4, 5, 6]. For example, one study confirmed a dose-response benefit of eight weeks of NRT versus two weeks . In addition to its direct impact on quit rates for participants, multiple studies in the US have found that cyclical promotional campaigns offering brief courses of NRT can dramatically increase quit attempts, with 10-fold and 20-fold increases in calls [7, 8], and that the promotional benefit of NRT used in this way is as or more cost-effective than media promotions for generating calls to quitlines. However, it is unlikely that these types of effects could be generated in the UK where free or low-cost medication access is much easier to access and ubiquitous.
We are delighted that research continues on examining the effectiveness of NRT in real world settings such as quitlines.
Tim McAfee, MD, MPH, Director, Office of Smoking and Health, Centers for Disease Control and Prevention
Jeffrey Fellows, PhD, Investigator, Center for Health Research, Kaiser Permanente
Susan M. Zbikowski, PhD, Senior Vice President, Alere Wellbeing, Inc.*
* Corresponding Author: Susan M. Zbikowski, PhD, Alere Wellbeing, firstname.lastname@example.org.
1. Ferguson J, Docherty G, Bauld L, Lewis S, Lorgelly P, Boyd KA, McEwen An, Coleman T. Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: Randomised controlled trial. BMJ 2012;344:e1696.
2. Hollis JF, McAfee T, Fellows J, Zbikowski S, Stark M. Riedlinger K. The effectiveness and cost-effectiveness of telephone counseling and the nicotine patch in a state tobacco quitline. Tob Control 2007;16(S1):i53-i59.
3. Stead LF, Perera R, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database Syst Rev 2006; (database online);(3).
4. Fiore MC, Jaen CR, Baker TB, et al. Treating tobacco use and dependence: 2008 update (US Department of Health and Human Services, Public Health Service, Rockville, MD).
5. McAfee TA, Bush T, Deprey TM, Mahoney LD, Zbikowski SM, Fellows JL, McClure JB. Nicotine patches and uninsured quitline callers. A randomized trial of two versus eight weeks. Am J Prev Med. 2008 Aug;35(2):103-10.
6. Fellows JL, Bush T, McAfee , Dickerson J. Cost effectiveness of the Oregon quitline “free patch initiative.” Tob Control 2007;16:Suppl 1 i47-i52 doi:10.1136/tc.2007.019943.
7. Sheffer MA, Redmond LA, Kobinsky KH, Keller PA, McAfee T, Fiore MC. Creating a perfect storm to increase consumer demand for Wisconsin’s tobacco quitline. Am J Prev Med. 2010 Mar;38(3 Suppl):S343-6.
8. An LC, Schillo BA, Kavanaugh AM, Lachter RB, Luxenberg MG, Wendling AH, Joseph AM. Increased reach and effectiveness of a statewide tobacco quitline after the addition of access to free nicotine replacement therapy. Tob Control. 2006 Aug;15(4):286-93. PMID:16885577.
Competing interests: Susan Zbikowski is employeed by Alere Wellbeing, a quitline service provider in the US. The other authors (TM, JF) have no competing interests.