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Adherence improvement using Shared Decision in tobacco

dependence treatment. Open randomized controlled clinical trial.


Aguilar JP1; Tarcisio MA2
1Universidade Federal da Bahia , Programa de Ps-Graduao em Medicina e Sade, Av. Reitor Miguel Calmon, S/N,
Canela, Salvador, Ba - Brasil, E-mail: pkjpablo@gmail.com, (71)984318399, Sociedad Civil Empodrate, La Paz,
Bolivia.2Docente na Universidade Federal da Bahia- Programa de Ps-Graduao em Medicina e Sade, E-mail
Universidade Federal tarcisio@ufba.br Faculdade de
da Bahia Medicina da Bahia

Table 1. Primary outcomes and measure of absolute reduction risk among two
Introduo tobacco dependent groups of patients, one of them using ShD in Salvador,
Brazil 2015-2016
Tobacco use is a global epidemic that causes around 6 million of deaths
per year 1. Treatment of tobacco dependence in Brazil is free and is ShD group Control group p
covered by Brazilian Public Health System (SUS). But researches that Characteristics ARR
value
evaluate this program, show low participation rate and cessation. (n=34) (n=30)
Shared Decision (ShD) is the pinnacle of patient-centered care and it Morisky-Green scale1
can improve the adherence to tobacco dependence treatment 2-4. Do you ever forget to take your medicine?
9 25.7 18 52.9 0.021 28.6%
number (%)
.
Are you careless at times about taking
12 34.3 21 61.8 0.022 27.5%
Objective your medications? number (%)
When you feel better, do you sometimes
6 17.1 10 29.4 0.227 17.2%
stop taking your medications? number (%)
To compare the adherence to tobacco dependence treatment between
Sometimes, if you feel worse when you
two groups of patients: control group - the type of treatment is chosen take your medicine, do you stop taking it? 5 14.3 6 17.6 0.539 6.3%
by the physician, and intervention group - the type of treatment is number (%)
chosen using ShD. Patients adherents, according the MG scale
15 42.9 3 8.8 0.001 44.1%
number, number (%)1
Day of participation in the first four weeks of
Method 3.8 0.4 3.2 1.0 0.040*
the CBT, mean (SD)
Day of participation in CBT at the end of 12-
8.8 2.8 7.3 3.1 0.018*
Clinical trial with 12-week follow-up, 104 smokers were recruiting and weeks, mean (SD)
therapeutic resources recommended by INCA (Brazilian National Patients adherents in the first four weeks of
39 97.5 33 75.0 0.003 45.8%
CBT, mean (SD)
Cancer Institute) were used: Cognitive Behavioral Therapy (CBT), with
Patients adherents in CBT at the end of 12-
or without drug therapy (nicotine patch or bupropion). weeks, mean (SD)
25 62.5 21 47.7 0.174 14.9%
Abandonment of tobacco dependence
6 15.0 17 38.6 0.015 29.7%
treatment
Results
1. Only employed in patients who used some type of medication; (ShD group
Participants were 104 smokers enrolled and randomized in ShD group or n= 35 and Control group n= 34)
usual treatment, their sociodemographic and clinical characteristics * Students t test: and the rest chi-square test
doesnt significant distribution between groups at base line, 84 patients ShD = shared decision; CBT = cognitive behavioral therapy; MG escale =
completed the study. Patients with ShD (n=40) according to Morisky Morisky-Green scale; SD= Standard deviation; IC 95% = 95% confidence
Green Scale had better adherence compared to control (42.9% vs 8.8% interval
p= 0.001); Absolute Risk Reduction (ARR) to not be adherent to the
treatment of 44.1% (95%CI= 22.3 to 65.9) and a Number Needed to
Treat of 3 (95%CI 2 to 5) to have an adherent patient. Participation in Table 2. Secondary outcomes and measure of absolute reduction risk among
CBT in the first month was higher in the ShD group (97.5% vs 75.5%, p= two tobacco dependent groups of patients, one of them using ShD in Salvador,
0.04); at the last month it was similar. At the end, abandonment was Brazil 2015-2016
higher in the control group (15.0% vs 38.6%, p= 0.015); ARR of 29.7%
(CI= 7.8% - 51.5%).
ShD group Control group P
Characteristics RAR
value
(n=34) (n=30)
Number of cigarettes/day after the first four
15.4 (10.1) 10.4 (8.9) 0.026*
weeks treatment, mean (SD)
Number of cigarettes/day at the end of 12-
19.2 (12.4) 15.5 (11.7) 0.281*
weeks, mean (SD)
Abstinence patients in the first 4 weeks
15 (37.5) 10 (22.7) 0.139 17.6%
number (%)
Abstinence patients at the end of 12-weeks,
25 (62.5) 20 (45.5) 0.118 17.1%
number (%)
Kappa Index 1
Between the groups and INCAs protocol,
0.5 (0.001) 0.7 (<0.001)
kappa index (p-value)

1. Kappa Index between the type of treatment chosen in both groups vs the
INCAs protocol; Values equal to 0 = no agreement, 0 to 0.19 = poor
agreement, 0.20 to 0.39 = weak agreement, 0.40 to 0.59 moderate
agreement, 0.60 to 0.79 substantial agreement, 80 to 1 = perfect
agreement.
ShD = shared decision; SD Standard deviation; IC 95% = 95% confidence
interval.
*Mann-Whitney U test: and the rest chi-square test

Conclusion

Patients who had the opportunity to choose the type of treatment, had better
Graphic 2 flow chart
adherence compared with those patients who had a usual treatment. The
ShD = shared decision; CBT = cognitive behavioral therapy
use of ShD to treat tobacco dependence does not deviate from the INCA
criteria.

Bibliographic

1. Eriksen M, Mackay J, Schluger N, Gomeshtapeh FI, Drope J. The tobacco atlas. 5th ed. Atlanta, Georgia USA: American Cancer Society, World Lung
Foundation;2015.
2. Warner DO, LeBlanc A, Kadimpati S, Vickers KS, Shi Y, Montori VM. Decision Aid for Cigarette Smokers Scheduled for Elective Surgery. Anesthesiology.
2015;123(1):18-28.
3. Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, et al. Decision aids for people facing health treatment or screening decisions. Cochrane
Database Syst Rev. 2014(1):CD001431.
4. Joosten EA, De Jong CA, de Weert-van Oene GH, Sensky T, van der Staak CP. Shared decision-making: increases autonomy in substance-dependent
patients. Subst Use Misuse. 2011;46(8):1037-8.

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