Amaral, Lígia Menezes do; Macêdo, Ângela Caroline Dias Albino Destro de; Lanzieri, Isabella Oliveira; Andrade, Rafaela de Oliveira; Richter, Kimber P.; Leite, Isabel Cristina Gonçalves

doi:10.1590/1806-9282.66.6.849

Lígia Menezes do Amaral

. Departamento de Clínica Médica, Faculdade de Medicina, Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brasil.

https://orcid.org/0000-0001-9795-6698

Ângela Caroline Dias Albino Destro de Macêdo

. Bolsista de Iniciação Científica (BIC). Faculdade de Medicina, Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brasil.

https://orcid.org/0000-0002-5280-9157

Isabella Oliveira Lanzieri

. Bolsista de Iniciação Científica (Pibic) Faculdade de Medicina, Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brasil.

https://orcid.org/0000-0003-1272-2193

Rafaela de Oliveira Andrade

. Bolsista de Iniciação Científica (Pibic) Faculdade de Medicina, Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brasil.

https://orcid.org/0000-0001-5460-7199

Kimber P. Richter

. Department of Population Health. University of Kansas Medical Center, Kansas City, Kansas, USA.

https://orcid.org/0000-0002-0351-4336

Isabel Cristina Gonçalves Leite

. Departamento de Saúde Coletiva. Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brasil.

https://orcid.org/0000-0003-1258-7331

CORRESPONDING AUTHOR: Lígia Menezes do Amaral. Rua Curitiba, 163, casa 4, Jardim da Serra, Juiz de Fora, MG, Brasil - 36038-600. Tel: +55 32 98807-7273. E-mail: ligia.amaral2013@gmail.com

Authors’ contribution

Lígia Menezes do Amaral: Conception and planning of the work, interpretation of the evidence, data collection, writing, revision of the preliminary and final versions; Ângela C. D. Albino Destro de Macêdo: Data collection and writing; Isabella Oliveira Lanzieri: Data collection and writing; Rafaela de Oliveira Andrade: Data collection and writing; Kimber P. Richter: Writing, revision of the preliminary and final versions and approval of the final version; Isabel C. Gonçalves Leite: Design and planning of the work, interpretation of the evidence, data collection, writing, review of the preliminary and final versions and approval of the final version.

Study/ Year of publication	Country/ Follow-up Period	n and special characteristics	Group(s)/Intervention/Post-Discharge Intervention	Control Group/Post-Discharge Intervention	Cessation outcome/Results (statistically significant difference)
Dornellas et al. 2000	USA Unicentric Feb. 1996 Jan. 1997	100 Patients hospitalized with acute myocardial infarction	Single group (n = 54) • Bedside counseling during hospitalization (20 minutes) and post-discharge telephone counseling, with calls at 1, 4, 8, 12, 16, 20, 26 weeks post-discharge	(n = 46) • Oriented to access institutional video during hospital stay • No interventions after discharge	Self-reported abstinence for 7 days and confirmed by cohabiting, 6 and 12 months after discharge Results There was a difference between the groups • 6 months: - Intervention group = 67% - Control group = 43% (p <0.05) • 12 months: - Intervention group = 55% - Control Group = 34% (p <0.05)
Hennrikus et al. 2005	USA Multicenter (4 hospitals) Jan. 1997 Jul. 1999	2,095 Smokers hospitalized for multiple causes	Group 1 (n = 703) • Modified standard care and note highlighted in the patient's record, recommending advice by the assistant team Group 2 (n = 696) • Modified standard care, note highlighted in the medical record and additional telephone counseling sessions - ≥ 1 - 617 (90%) - ≥ 4- 318 (63%) - ≥ 7 -88 (13%)	(n = 696) • Modified standard care, 2 manuals and referral to community cessation programs	• Outcome 1: Self-reported abstinence for 7 days, 7 days post-discharge • Outcome 2: Self-reported abstinence for 7 days, 12 months after discharge • Outcome 3: Abstinence for 7 days, 12 months after discharge confirmed by salivary cotinine Results There was a difference in relation to outcome 2 • Outcome 1: - Group 1 = 24%; - Group 2 = 25.2% - Control group = 26% - (p> 0.05) • Outcome 2: - Group 1 = 15.2% - Group 2 = 19.8% - Control group = 15% - (p <0.05). • Outcome 3: - Group 1 = 10% - Group 2 = 9.9% - Control group = 8.8% - (p> 0.05)
Reid et al. 2007	Canada Pilot Unicentric Nov. 2004 May 2015	100 Smokers hospitalized for coronary disease	Single group (n = 50) Standard care during hospitalization, RIV 3, 14 and 30 days post discharge and additional counseling as needed	(n = 50) • Standard care during hospitalization, access to NRT and printed material. No other interventions after discharge	Self-reported abstinence in the last 7 days, 52 weeks after discharge Results There was no difference between groups Intervention group = 46% Control group = 34.7% (p = 0.25)
Regan et al. 2011	USA Unicentric Dec. 2007 Jul. 2008	738 Smokers hospitalized for multiple causes	Single group (n = 368) • IVR (4 times) in the 30 days after discharge and possibility of requesting a callback by the counselor	(n = 379) • An IVR 2 weeks after discharge	Self-report of cessation 2 and 12 weeks after discharge Results There was no difference between the groups studied • Withdrawal 2 weeks after discharge - Intervention group = 39% - Control group = 39% - RR 1.02 - CI = 0.85–1.22 • Abstinence 12 weeks after discharge - Intervention group = 29% - Control group = 26% - RR 1.11 - CI = 0.9–1.41
Rigotti et al. 2014	USA Unicentric Aug. 2010 Apr. 2012	397 Smokers hospitalized for multiple causes that: • Received counseling during hospitalization • Planned to quit smoking • Accepted the pharmacological treatment	Single group (n = 198) • Medication for 30 days, with replacement twice for up to 90 days, 5 IVR (2, 14, 30, 60 and 90 days after discharge) and fax to the primary care physician informing about the treatment	(n = 199) • Recommendation for free call to quitline, individualized recommendation for medication and note in the medical record alerting the attending physician about the prescription of medication	Biochemically proven abstinence for 7 days, 6 months after discharge (cotinine, or monoxymetry for those using NRT), self-reported abstinence for 7 days and abstinence continues 2.3 and 6 months after discharge Results There was a difference between the groups in the main outcome and in some secondary outcomes • Biochemically proven withdrawal: - Intervention group = 26% - Control group = 15% - (p = 0.009) • Self-reported abstinence last 7 days 6 months after discharge: - Intervention group = 40.9% - Control group = 28.1% - (p = 0.008) • Continuous self-reported abstinence 6 months after discharge: - Intervention group = 27.3% - Control group = 16.1% - (p = 0.007) • Other outcomes without statistically significant difference between groups
Cummins et al. 2016	USA Multicenter Jun. 2011 Nov. 2013	1,270 Smoking patients hospitalized in 5 hospitals	Group 1 (n = 320) • Nicotine patches Group 2 (n = 317) • Nicotine patches and telephone advice Group 3 (n = 317) • Telephone advice	(n = 316) • Standard care: quitline	Self-reported abstinence for 7 and 30 days, 2 and 6 months after discharge, and salivary cotinine-confirmed abstinence in those who reported abstinence for 7 days, 6 months after discharge. Result There was no difference between the intervention groups and the control group or between the different intervention groups in any of the analyzed outcomes Main outcome: • Abstinence for 30 days, 6 months after discharge: - Groups without patches = 18.3% - Groups with patches = 22.8% - (p = 0.051) • Counseling groups = 21.1% • Groups without counseling = 20.0% • (p = 0.65)
Fellows et al. 2016	USA Multicenter Nov. 2011 Nov. 2013	898 Smoking patients hospitalized for multiple causes	Single group (n = 597) • Approach during hospitalization • Proactive reference for post discharge assistance • Pharmacotherapy (offered according to a health plan) and 4 IVR 4, 14, 28 and 49 days after discharge	(n = 301) • Approach during hospitalization • Standard care after discharge: - Information on medications and how to access quitline. - A brief follow-up call to assess cessation	Self-reported abstinence in the last 30 days, 6 months after randomization Result: There was no difference in cessation between the two groups in the primary or secondary outcomes related to cessation • Intervention group = 24% • Control group = 22% • (p = 0.159)
Harrington et al. 2016	USA Unicentric Jul. 2011 May 2013	1,488 Smokers hospitalized for multiple causes	Single group (n = 748) • Approach during hospitalization and time of discharge (Standard Care), visit by a team that guided access, registration and use of website with various information on smoking	(n = 740) • Standard care	Self-reported abstinence for 30 days, 6 months after discharge Results: There was no difference between groups • Intervention group = 25.8% • control group = 24.1% • (p = 0.436)
Sherman et al. 2016	USA Jul. 2011 Apr. 2014	1,619 Smokers hospitalized for multiple causes, with a high number of participants on the street or in temporary housing (25%) alcohol users (40%), and with mental illness (50%) and use of other drugs (60%)	Single group (n = 805) • Post-discharge counseling calls (proactive), 2 weeks after discharge, other calls 1, 3, 7, 14, 30 and 42 days after the first call	(n = 814) • Referred to the quitline	Self-reported abstinence for 30 days, 2 and 6 months after discharge Results: There was a difference between the groups • Withdrawal 2 months after discharge: - Intervention group = 29.0% - Control group = 20.7% - (RR 1.40 CI = 1.13, 1.73) • Withdrawal 6 months after discharge: - Intervention group = 37.4% - Control group = 32.5% - (RR 1.19 CI = 1.01, 1.40)
Richter et al. 2016#	USA Multicenter Jul. 2011 Out. 2014	1,054 Smokers hospitalized for multiple causes	Single group (n = 527) • Assessment of withdrawal symptoms, adjustment of the NRT dosage (standard care). Explanations about the project. Quitline registration mediated by the researcher	(n = 527) • Standard Care, assistance with cessation (quit plan + providing medication prescription after discharge) and forwarding via fax to quitline	• Abstinence in the last 7 days, self-reported, 6 months after discharge • Biochemically confirmed abstinence (cotinine, carbon monoxide, proxy) 6 months after discharge Results There was no difference between the groups studied • Self-reported abstinence for 7 days, 6 months after discharge: - Intervention group = 25.4% - Control group = 25.3% - (p = 0.88) • Abstinence confirmed for 7 days 6 months after discharge (carbon monoxide and cotinine): - Intervention group = 23.7% - Control group = 21.6% - Oradj = 1.02 - 95% CI = 0.77, 1.35 - (p = 0.88) - RR = 1.02 - 95% CI = 0.82; 1.24
Rigotti et al. 2016	USA Multicenter Dec. 2012 Jul. 2014	1,359 Smokers hospitalized for multiple causes who: • Received counseling at hospitalization • Planned to quit smoking • Accepted the pharmacological treatment	Single group (n = 681) • Medication for 30 days, with replacement twice for up to 90 days, 5 IVR (2, 12, 28, 58 and 88 days after discharge) and possibility to access a counselor if necessary	(n = 678) • Recommendation for free call to quitline (1-800-QUIT-NOW), individualized recommendation for medication • Note in the medical record alerting the attending physician about the medication prescription	Biochemically proven abstinence for 7 days, 6 months after discharge (cotinine or monoxymetry for those using NRT) Self-report abstinence assessment at 1, 3 and 6 months Results There was a difference between groups in outcome 2 • Biochemically proven abstinence: - Intervention group = 17% - Control group = 16% - (p = 0.58) • Self-reported abstinence for 7 days, 1 month after discharge: - Intervention group = 43% - Control group = 32% - (p <0.0001) • Self-reported abstinence for 7 days, 3 months after discharge: - Intervention group = 37% - Control group = 30% - (p = 0.008) • Self-reported abstinence 6 months after discharge: - Intervention group = 31% - Control group = 27% - (p = 0.09)
Thomas et al. 2016	Australia Multicenter Apr. 2012 Jun. 2014	600 Smokers hospitalized for multiple causes	Single group (n = 300) • Behavioral approach (2 sessions in the hospital and 3rd session 4 weeks after discharge). Motivational interview for those who did not want to quit smoking. Pharmacotherapy during hospitalization and 1 week after discharge. Pharmacotherapy for another 28 days according to availability (PBS). Impressive information material, quitline reference, case summary and action plan for assistant physician and community pharmacist and follow-up by telephone at 1, 6 and 12 months after discharge	(n = 300) • Standard care for each hospital: - Brief intervention during hospitalization - Available pharmacotherapy: NRT, bupropion and varenicline maintained for a period of 28 days after discharge according to PBS and follow up by phone at 1, 6 and 12 months after discharge	Abstinence for 30 days, six months after discharge, confirmed with monoxymetry Abstinence for 6 months, 12 months after discharge, also by monoxymetry Self-reported abstinence for 30 days at 1, 6 and 12 months Results There was no difference between groups • Abstinence for 30 days, six months after discharge, confirmed with monoxymetry: - Intervention group = 11.6% - Control group = 12.6% - (OR) = 0.91 - 95% (CI) = 0.55–1.50 • Abstinence for 30 days, 12 months after discharge, confirmed with monoxymetry - Intervention group = 11.6% - Control group = 11.2% - OR = 1.04 - 95% CI = 0.63–1.73 • Self-reported abstinence for 30 days in 1, 6 and 12 months - 1 month: Intervention group = 28.8% Control group = 23.4% OR 1.56 (1.05–2.33) - 6 months: Intervention group = 28.8% Control group = 23.4% OR 1.47 (0.91–2.39) - 12 months: Intervention group = 13.0% Control group = 12.2% OR 1.21 (0.72–2.03)
Busch et al. 2017	USA Pilot Unicentric Out. 2013 Apr. 2015	59 Smoking patients hospitalized for acute coronary syndrome	Single group (n = 28) • Five counseling sessions in weeks 1, 3, 6, 9 and 12 post discharge. Up to 4 additional contacts according to need	(n = 31) • Received informative material at weeks 1, 3, 6, 9 and 12 after discharge	Abstinence in the last 7 days, confirmed by monoxymetry, assessed at the 12th and 24th weeks after discharge. Result There was no difference between the intervention groups and the control group • 12th week: • Intervention group = 48.0% • Control group = 44.8% • 24th week: • Intervention group = 45.8% • Control group = 42.3%
Cruvinel 2016	Brasil Pilot Unicentric Jun. 2015 Mar. 2016	66 patients Hospitalized smokers	Single group (n = 44) • Brief approach, informative material printed during hospitalization, in addition to NRT for 4 weeks (standard care) • And 1 phone call and text messages after discharge	(n = 22) • Standard care and 1 follow-up call 30 days after discharge	Self-reported abstinence in the last 7 days, 30 days after discharge and 90 days after discharge Abstinence confirmed by monoxymetry 90 days after discharge Result There was no difference between the groups in the 1st and 3rd outcomes and there was a difference in the 2nd outcome • 30 days after discharge: - Intervention group = 25.0% abstinence - Control group = 9.1% - (p = 0.13) • 90 days after discharge: - Intervention group = 31.8% - Control group = 9.1% - (p = 0.04) • Abstinence confirmed by monoxymetry: - Intervention group = 20.5% - Control group = 4.5% - (p = 0.09)

Study	Type	Initial Dose	Time	Difference between control and intervention groups
Dornelas et al.¹⁰	NRT	Not informed	Not informed	No. Approximately 24% of participants in both groups. No statistic data
Hennrikus et al.¹¹	NRT Bupropion	Not informed	Not informed	No. No additional data (e-mail sent to the author)
Reid et al.¹²	NRT Bupropion	Not informed	Not informed	No. NRT: Intervention Group: 14% Control Group: 14.3% (p = 0.85) Bupropion: Intervention Group: 8% Control Group: 4.1% (p = 0.60)
Regan et al.¹³	NRT Bupropion Varenicline Other non-specified mediation	Not informed	Not informed	No Intervention group: 69% Control group: 52% (p < 0.05)
Rigotti et al.¹⁴	NRT, Bupropion varenicline (Isolated or combined)	Not informed	Intervention group: up to 90 days Control group: non-specified	Yes. Intervention group: it was provided. Intervention group: 79 % Control group: 59% RR, 1.34 [95% CI, 1.17-1.54]; (p < 0.001)
Cummins et al.¹⁵	NRT	14 to 21 mg according to number of cigarettes smoked	08 weeks	Yes. Medication was part of the strategy in two of the intervention groups.
Fellows et al.¹⁶	NRT Bupropion Varenicline	Not informed	Not informed	No. Intervention group: 47.0% - Control group: 38.0% (p = 0.013)
Harrington et.¹⁷	NRT Bupropion	Not informed	Not informed	No. Intervention group: 25.9% Control group: 26.0% (p = 1.00)
Sherman et al.¹⁸	NRT	Not informed	Not informed	No. Intervention group: 44% Control group: 44%
Richter et al.⁷	NRT - During hospitalization and prescribed after discharge		Not informed	No Intervention group: 23% Control group: 26% (p = 0.23)
Rigotti et al.¹⁹	NRT Bupropion Varenicline, (Isolated or combined)	Not informed	Up to 90 days. -Control group: Non-specified	No. Intervention group: 83.7% - Control group: 60.6% RR 1.38 [95% CI, 1.29-1.48]; (p < 0.001)
Thomas et al.²⁰	NRT Bupropion Varenicline After discharge, these same medications were offered for 28 days in a co-participation regime.	Not informed	During hospitalization and for at least 28 days after discharge	Yes Intervention group: 43.1% Control group: 28.8% (p < 0.001)
Busch et al.⁶	NRT – Patches	14 to 21 mg according to the number of cigarettes smoked	08 weeks	Intervention group: 67.9% Control Group: 58.1% (p value not informed)
Cruvinel²¹	NRT	14 to 21 mg according to the number of cigarettes smoked	04 weeks	No Intervention group: 27.3% Control Group: 36.4% (p = 0.44)

Study/Areas of Bias	Selection		Performance	Detection	Friction	Report	Other/main limitations mentioned by authors
Study/Areas of Bias	Random sequence	Blinded Allocation	Performance	Detection	Friction	Report	Other/main limitations mentioned by authors
Dornelas et al 2000	B	I	A*	I	B	B	The outcome of cessation was assessed by self-report.
Henrikus et al 2005	B	I	A*	I	B	B	The absence of medication supply is reported by the authors as a possible factor of interference in the prevalence of cessation.
Reid et al 2007	B	I	A*	I	B	B	Pilot study, data analysis should be carried out with caution.
Regan et al 2011	B	B	A*	B	B	B	No biochemical evaluation of cessation at 1 and 3 months. The impossibility of separating the contributions of voice calls and medication in the treatment effect. Only patients willing to quit smoking after discharge were evaluated.
Rigotti et al 2014	B	B	A*	I	B	B	Single center and it was not possible to separate the effect of medication from the effect of the RIV.
Cummins et al 2016	B	I	A*	B	B	B	Over 90% of the patients who were hospitalized and smokers were not included in the study due to limited resources (harming the generalization of results). Only smokers interested in quitting were evaluated. The biochemical confirmation of cessation by cotinine occurred in only 57% of the participants.
Fellows et al 2016	B	B	A*	B	B	B	Low level of recruitment in two of the hospitals Follow up with various strategies.
Harrington et al 2016	B	B	A*	B	A	B	Low adherence to the strategy provided to the intervention group.
Sherman et al 2016	B	B	A*	I	B	B	Self-reporting with a high tendency of the sample providing unreliable reports when biochemical validation (cotinine) was performed.
							Counseling in the intervention group was carried out by a trained researcher and not by a member of the healthcare team.
Richter et al 2016	B	B	A*	B	B	B	Counseling in the intervention group was initially provided the hospital environment, which is turbulent
Rigotti et al 2016	B	B	A*	A	B	B	Cessation validity Biochemically only for the six-month outcome It was not possible to separate the effect of the medication from the effect of interactive voice calls. Applicable only to hospitalized patients who wished to stop smoking and accepted medication use. Losses of 25% of follow up in both groups; 31% did not provide saliva for the biochemical confirmation of cessation. In those who did provide it, cessation was not confirmed in 27% of the sample
Thomas et al 2016	B	B	A*	B	A	B	Possible contamination of interventions in the control group performed by pharmacists trained. Standard care varied in the different hospitals studied
Busch et al 2017	B	B	A*	B	B	B	A Pilot study, results analysis should be carried out with caution.
Cruvinel 2018	B	B	A*	B	B	B	Pilot study , results analysis should be carried out with caution..

[1] CORRESPONDING AUTHOR: Lígia Menezes do Amaral. Rua Curitiba, 163, casa 4, Jardim da Serra, Juiz de Fora, MG, Brasil - 36038-600. Tel: +55 32 98807-7273. E-mail: ligia.amaral2013@gmail.com

Brasil

Brasil

Promoting cessation in hospitalized smoking patients: a systematic review

RESUMO

OBJETIVO

MÉTODOS

RESULTADOS

CONCLUSÃO