abstract of thesis entitled women during prenatal and postnatal … yee... · 2016. 9. 26. ·...
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Abstract of thesis entitled
Evidence based practice of smoking cessation intervention for expectant fathers of pregnant
women during prenatal and postnatal period
Submitted by
Yu Yee Wa Eva
for the Degree of Master of Nursing
at The University of Hong Kong in
July 2016
Background:
There are numbers of smoking cessation service in Hong Kong provided for general public,
hospitalised patients and female smokers. However, smoking does not only affect the health of
smokers only but people around them, such as family members. Secondary-hand Smoking (SHS)
affects profoundly on pregnant women and the fetus they carry. In foreign countries like Canada,
organisations provide cessation services targeted on expectant fathers of pregnant women in view of
the harm SHS caused on the women and also the unborn children. Meanwhile, there is no similar
service target on this group of male smokers in Hong Kong. In view of the severe health issues,
medical system burden and economic loss that brought by the smoking expectant fathers, it reveals
a need for such programme to be implemented. In several studies, the couple-interaction was
considered to be included as an element of the cessation, at the “teachable moment” during
pregnancy and postnatal period. Therefore, an innovation was designed to help smoking expectant
fathers to quit smoking.
Purpose:
The purpose of this paper was to review the relevant existing literatures about helping
expectant fathers to quit with different approaches and interventions, discuss and critique he
strengths and limitations of different aspects of the studies and translate the data into an evidence-
based practice (EBP) guideline for potential users (healthcare professionals). Implementation plan,
pilot study and evaluation plan were also elaborated to ensure the practice of the innovation.
Method:
From PubMed, EBSChost and computerised database of library of The University Hong
Kong, 6 studies were selected based on the inclusion criteria. After quality assessment of these
studies in different aspects, with the grading guideline of Scottish Intercollegiate Guidelines
Network system (SIGNS), data was synthesized and an EBP guideline was developed. The
implementation potential of such EBP was discussed in terms of transferability, feasibility and cost-
benefit ratio in the proposed clinical setting. In order to gain approval and support from policy
makers, detailed communication plan with the stakeholders, pilot study plan and evaluation plan
were developed with the basis was set to determine the effectiveness of the innovation.
Results:
From the studies, it was found that couple interaction could be one of the keys in changing
partners’ smoking status and short-term positive effects in abstinence could be obtained. With the
development of a formal EBP, healthcare professionals could provide proper cessation interventions
to the expectant and newborn’s fathers during antenatal and postnatal period in different formats
including face-to-face and telephone counselling, written materials and video. Data of 7-day and
30-day point prevalence of abstinence, no. of quit attempt, no. of cigarette smoked per day would
be acquired at baseline , and post-intervention follow-up.
Conclusion:
An EBP guideline of smoking cessation service, delivered by healthcare professionals, for
expectant fathers during antenatal and postnatal follow-ups should be developed to enhance the
current cessation services in Hong Kong.
Evidence based practice of smoking cessation intervention for expectant
fathers of pregnant women during prenatal and postnatal period
by
Yu Yee Wa Eva
B.Nurs. C.U.H.K.
A thesis submitted of the requirements for the Degree of Master of Nursing
at The University of Hong Kong. July 2016
(word count : 9907)
Declaration
I declare that this dissertation represents my own work, except where due acknowledgement
is made, and that it has not been previously included in a thesis, dissertation or report submitted to
this University or to any other institution for a degree, diploma or other qualifications.
Signed _____________________________
ii
Acknowledgements
I would like to express my gratitude wholeheartedly to my supervisor, Dr. Wang Man Ping,
Kelvin, for his genuine guidance and assistance throughout the development of this thesis. His
professional knowledge in the aspect of smoking cessation provided fruitful information and thus
inspired me tremendously in designing an innovation that could be potentially beneficial to the
public.
Also, I would like to thank my family who offered unlimited support during these two years
during the study of the Master of Nursing.
iii
Table of Contents
Abstract
Declaration………………………………………………………………………………………….. i
Acknowledgements………………………………………………..……………………………….. ii
Table of Contents………………………………………..………………………………..….……. iii
Chapter 1: Introduction………………………………………………………………………p.1-p.5
1.1 Background
1.2 Affirming the needs
1.3 Objectives and Significance
Chapter 2: Critical Appraisal……………………………………………………………….p.6-p.17
2.1 Search and Appraisal Strategies 2.2 Search Results
2.3 Table of Evidence
2.4 Appraisal results
2.4.1 Recruitment methods
2.4.2 Methodological issues
2.4.3 Method in delivering the interventions and level of its exposure by
smoking partners
2.4.4 Types of interventions components
2.4.5 Result of studies
2.4.6 Outcome measurement methods
2.5 Conclusion
Chapter 3: Implementation Potential and Clinical Guideline…………………………p.18-p.26
3.1 Target audience and setting
iii
3.2 Transferability
3.2.1Target setting
3.2.2 Target audience
3.2.3 Philosophy of care
3.2.4 Adequacy of clients to benefit
3.2.5 Implementation and evaluation time
3.3 Feasibility
3.3.1 Freedom to implement
3.3.2 Interference with current functions
3.3.3 Administration and organizational support
3.3.4 Consensus and friction among staff
3.3.5 Skills needed to implement intervention and staff development
3.3.6 Facilities available to implement the intervention
3.3.7 Evaluation tools available
3.3.8 Cost-benefit ratio of the innovation
3.3.9 Costs
3.4 EBP Guideline
Chapter 4: Implementation Plan…………………………………………………………p.27-p.31
4.1 Communication plan with stakeholders and potential users
4.1.1 Communication with administrative level stakeholders
4.1.2 Communication with middle-level staff
4.1.3 Communication with frontline staff
4.1.4 Formation of working group
4.1.5 Communication with public
iii
4.2 Pilot Test
4.2.1 Aims
4.2.2 Details of pilot test
4.2.3 Evaluation
Chapter 5: Evaluation Plan…………………………………………………………….…………p.32-p.35
5.1 Outcomes identified and measurements
5.1.1 Clients’ outcomes and evaluation
5.1.2 Staff outcomes and evaluation
5.1.3 System outcomes and evaluation
5.2 Data Analysis
5.3 Determination of effectiveness
Chapter 6: Conclusion………………………………………………………………………….……..…p.36
List of appendices……..………..…………………………………………………………………..……… iv
References……………..………..………………………………………………………………..…………. v
1
Chapter 1: Introduction
1.1 Background
In Hong Kong, 10.7% of people aged 15 or above are daily cigarette smoker, with majority
19.1% were male, which were slightly decreased from 22% since 2000. More than half of the male
daily cigarette smokers had never tried and did not want to quit smoking (Census and Statistics
Department, 2013).
Smoking affects the fetus of the smoking pregnant women, e.g. premature birth, Sudden
Infant Death Syndrome & birth defects etc. (Surgeon General’s Report on Smoking & Health,
2014). In the meta-analysis done by Leonardi-Bee et al. (2011), maternal second-hand smoke (SHS)
exposure was significantly related to an increased risk of stillbirth and congenital malformation;
studies also found increase of risk of low birth weight (Dejmek et al., 2002; Jaddoe et al., 2008;
Pogodina,2009).
In Hong Kong, 65% of non-smoking mothers reported to have SHS exposure at home
during pregnancy (Lam, Leung & Ho, 2001). Aveyard et al. (2005) found that 1/4 to 1/3 of pregnant
women that quitted smoking lived with smoking partners who had also quitted, which may be due
to the influence from the cessation behaviour or the intervention materials shared by their pregnant
partners. In the systematic review done by Flemming et al. (2015), at the time when pregnancy was
confirmed and in the immediate postpartum period were crucial time points providing cessation
intervention for expectant fathers. These put a light on the possibility in implementing smoking
cessation extended to the smoking expectant fathers. Since the majority of smokers in Hong Kong
are men, with the extensiveness of the exposure to SHS by pregnant women, smoking cessation for
expectant fathers are important in protecting pregnant women and the in-utero fetus.
2
1.2 Affirming the needs
Within those Hong Kong male ex-daily smokers who had quitted, 30% of them concerned
about SHS exposure towards family members, nearly 20% because of health reason with advice
from healthcare professionals (HCP), 11% of them did not want to set bad example to children and
3% of them quitted because of pregnancy of family member. In study done by Kwok et al. (2008),
infants, especially in their early life, with SHS exposure (< 3 metres) from any household member
were at higher risk of serious infectious morbidity; infants with baseline SHS exposure within 3
metres had their first hospitalisation due to infections earlier than the unexposed group. (Child
health Survey 2005-2006, 2009). Most of the SHS came from paternal smoking (Leung, Ho & Lam,
2004). SHS exposure to pregnant women and fetus costed HKD$27.1million for extra
hospitalisation and outpatient consultation (McGhee et al., 2005).
In Hong Kong public hospital system, pregnant women can make appointment for antenatal
(AN) and postnatal (PN) follow-up (FU). From Materal and Child Health Centers (MCHC) website
(2006, 2013), mothers are advised to seek cessation counselling from related organisation, but no
direct cessation counselling delivered during the FUs. In the Guidelines on Antenatal Care
published by The Hong Kong College of Obstetricians and Gynaecologists [HKCOG] (HKCOG,
2008), it only simply suggested “quitting at any gestation should be encouraged”.
No formal protocol of tailor-made smoking cessation intervention exist for pregnant women,
left alone for the expectant fathers. Also, there is no formal training for HCP who have chances to
deliver interventions regularly during scheduled FUs. Blackbum et al. (2005) stated that smoking
partners made cigarettes readily available and provided temptation to women who were trying to
quit. Also, mothers may shape the smoking behaviour of their partners (father lived with smoking
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partner had higher cigarette consumption; father lived with a non-smoking partner had significantly
lower household smoking consumption). They concluded that this spouse interaction should be
taken into consideration in the design of the smoking cessation which should be extended to fathers
as well. Same suggestions had also been proposed in other studies (Everett et al. 2005; Jeffrey et al.,
2011; Wang et al., 2014).
Clinical practice guidelines about smoking cessation involving pregnant women had been
issued from USA (U.S. Department of Health and Human Services Public Health Service (USPHS):
Treating Tobacco Use and Dependence (2008 Update), 2015; Registered Nurses Association of
Ontario, 2007), UK (National Institute for Health and Clinical Excellence [NICE], 2010) and New
Zealand (Ministry of Health, 2007) etc. The only father-centered intervention is in Canada namely
“Dads in Gear” (DIG), which involves use of internet and face-to-face sessions (Dads in Gear |
Suppoting New Father Who Want To Be Smoke-free, 2015). However, it does not involve the
pregnant women in the 8-week programme process. Pregnancy of partners can be a motivation for
these particular group of men to shape their smoking behaviours and have readiness to quit (Everett
et al., 2005; Bottorff et al., 2006), especially at the time of confirmation of pregnancy and when the
infants are born as mentioned before.
In the cross-sectional survey done by Tsung (2001), majority of the Registered Nurse had
positive attitudes towards smoking cessation but only 13.2% of them were trained. The underlying
factors in not providing interventions to their smoker patients include “lack of time” (~70%) and
“lack of resources” (64%). For physicians, >50% of the interviewers were lack of sufficient
knowledge or favourable attitude towards smoking cessation; nearly half of them were not
confident enough in their cessation techniques; nearly 80% of them would ask their patients for
smoking status but less than 30% of them suggested smoking patients to stop smoking (Abdullah et
al., 2006).
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Thus, involving expectant fathers in AN and PN process together with their pregnant
partner, with the provision of tailor-made smoking cessation intervention delivered by trained HCP
may yield positive effect in reducing smoking prevalence and maintain abstinence of the expectant
fathers, and may as well extend to the smoking pregnant women.
Nevertheless, suggestions for helping smoking partners to quit were insufficient. Only one
systematic review were published (Duckworth & Chertok, 2012) focusing on studies about partner-
specific intervention including 3 RCTs and 1 cohort study. However, there were 2 more new RCTs
published after this review had been done: one related to Chinese population and another one tried
to address the level of intensiveness of intervention needed. An updated review is needed on the
topic of intervention of smoking cessation targeted at pregnant women’s partner during pregnancy
and postpartum period.
1.3 Objectives and Significance
Integrating smoking cessation intervention into routine care for expect fathers may bring
positive effects in improving smoking prevalence of fathers, as well as that of mothers, so as to
protect the health of the whole family. However, lack of evidence-based practice in Hong Kong for
such service causes problems of pregnant women’s and fetus’ exposure of SHS, eventually leading
to extra economic costs mentioned beforehand. The PICO of this thesis is :
Population (P) - Smoking partners of pregnant women
Intervention (I) - Smoking cessation intervention directly/ indirectly for expectant
fathers during prenatal and postnatal FUs
Comparison (C) - Expectant fathers with no intervention delivered by HCP/ usual
care during prenatal and postnatal period
Outcome (O) - Improving expectant fathers’ smoking behaviour
Thus, in this thesis, the objectives include:
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1. Presenting systematic reviews and critical appraisal of the existing studies related to smoking
cessation intervention targeting at smoking partners of pregnant women during AN and PN FU.
1. Developing evidence-based protocol of smoking cessation intervention to help expectant
fathers to quit for HCP working in O&G department of public hospital.
2. Investigating the feasibility and transferability of such evidence-based protocol in Hong
Kong clinical setting.
3. Developing plan of implementation in target setting and evaluating the outcomes and
data analysis method.
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Chapter 2: Critical Appraisal
2.1 Search and Appraisal Strategies
In conducting the literature search, “PubMed”, “EBSChost” were utilised with keywords
“smoking”, “tobacco”, “cigarette”, “pregnant”, “pregnancy”, “women”, “cessation”, “quit”,
“intervention”, “trial”, “father”, “couple”, “men”, “partner” were used. Computerised database of
library of The University of Hong Kong were also searched. The titles and abstracts of articles were
screened and full-text articles were viewed when uncertainty was raised. The inclusion criteria are
smoking cessation intervention targeting at partners (smoker) of pregnant women and/ or pregnant
women (smoker or non-smoker), during AN with or without PN period <18months, published in
Chinese or English language from 2000 to present and limited to interventional studies only.
Exclusion criteria were non-intervention type studies (e.g. qualitative study) and studies that did not
have intervention aiming at changing the smoking behaviour of smoking partners.
2.2 Search Results
Within “PubMed” and “EBSChost”, 642 studies were searched. 3 RCTs met the inclusion
criteria were found in other sources. Excluding studies that were duplicated and did not meet the
inclusion criteria after assessing the fully-text articles, 6 studies were collected: 3 RCTs and 1
cohort study were duplicated with this systematic review, 2 remaining RCTs that were not included
in the Duckworth's & Chertok’s (2012) systematic review. Table 1 & 2 demonstrated the search
results and elimination flow.
2.3 Table of Evidence
Information of the 5 RCTs and 1 cohort study were extracted and formatted in to table of
evidence. The quality assessments of the studies were judged by using the critical appraisal
7
checklists from Scottish Intercollegiate Guidelines Network (SIGNS). The tables of evidence and
SIGNS checklists for the 6 RCTs can be found in appendix 2 & 3. The level of evidence was given
to these 6 studies by using SIGN Grading System (Appendix 1)
2 studies (both are RCTs) were classified as “1+” (Stanton, Lowe, Moffatt et al. 2004;
Pollak, Lyna, Biheimer et al., 2015). 3 studies (all are RCTs) were classified as “1-“ (Loke & Lam,
2005; de Vries, Bakker, Mullen et al., 2006; McBride et al., 2004). 1 study (controlled cohort study)
was classified as “2-“ (Oien , Storro, Jenssen et al., 2008).
2.4 Appraisal results
Five RCTs were identified (McBride et al., 2004; Staton et al., 2004; de Vries et al., 2006;
Loke & Lam, 2005; Pollak et al., 2015) and 1 cohort study (Oren et al., 2008). Two of them have
not been reviewed in Duckworth’s & Chertok’s systematic review (2012) (Loke & Lam, 2005;
Pollak et al., 2015). In the following, a brief introduction of the studies will be presented.
Study done by McBride et al. (2004) included 2 intervention groups: women-only (WO) and
partner-assisted (PA), comparing with control group (UC). In total 583 pregnant women (current
smokers or recent quitters, living with an intimate partner), they were assigned to the above 3
groups. UC received quit advice and self-help guide; WO received components of UC plus a
relapse-prevention kit and 6 counselling calls; PA received WO components, booklet and video
guiding couples about discussion of support behaviors and telephone calls. If partners were
smokers, they would be given self-help cessation guides, free nicotine patches and counselling. 7
days self-reported abstinence and sustained abstinence were the primary outcome. It was found that
the partner cessation rate in PA at 28-week gestation was significant higher than UC (15% vs 5%,
p=0.02).
Stanton et al. (2004) investigated the effect of direct intervention towards smoking partners
of pregnant women. Total 561 smoking expectant fathers were randomly assigned into intervention
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group (IG) and control group (CG). IG received video, nicotine patches, information pack and
support material; CG received brochure providing contacts of the available smoking cessation
choices. Self-report quit rate of these men was the primary outcome, with some of them were tested
with carbon monoxide level to determine the validity of the self-report results. It was found that IG
had a higher quit rate than CG (16.5% vs 9.3%, p=0.011).
de Vries et al. (2006) studied the effects of smoking cessation by Midwives on pregnant
women and their partners. 381 smoking pregnant women were randomly allocated into IG
(providing with video, self-help guide, booklet, booklet specialised for smoking partners and
counselling) and CG (receiving usual care plus a general folder from the Dutch Smoking and Health
Foundation). 7-day point prevalence abstinence , continuous abstinence, quit attempts of women
and change in partners’ smoking status were measured. There was no significant difference for the
change in partners’ smoking status (p>0.30 at all time points).
Oien et al. (2008) compared the subjects recruiting from 1/6/2002-15/12/2004 (intervention
cohort (IG)) and control cohort (CG) subjects from 1/9/2000 - 30/5/2002 in the same city. Pregnant
women in the CG received routine care at that time period. Women in IG were given brief
intervention at each AN visit and were invited to bring along their partners for cessation advice if
they were smokers. In the self-report smoking prevalence at 6-week PN, paternal smoking
prevalence was less than those in CG (14.5% vs 17.9%, p=0.05). Also, parental indoor smoking
prevalence in IG had less indoor smoking exposure than CG ( 5% vs 8%, p=0.04).
Loke & Lam (2005) was the only study involving Chinese population. 785 never-smoked
pregnant women were recruited. IG received standardised advice from obstetricians and educational
booklet for learning how to help their husbands to quit. CG received usual care only. The main
outcome was 7-day abstinence of husbands in which authors found IG had higher rate than CG
(p=0.04), with no significant difference in 30-day abstinence. No. of quit attempts was higher in IG
than CG ( 30% vs 22.2%, p=0.003). Also, IG had a higher reduced level of no. of cigarettes smoked
9
per day than CG ( 39.7% vs 17.7%, P<0.0001) with lower increased level of smoking in IG than in
CG ( 9.5% vs 11.6%, p<0.0001). All results were based on the report of smoking status of husbands
from the women.
Last but not least, the study done by Pollak et al. (2015) was about the comparison of the
effects of intensity of intervention towards the smoking behaviour of expectant fathers. They
recruited non-smoking pregnant women and smoking husbands in a total of 348 participants. The
men in more intensive group (IG) received written material, free NRT and 6 counselling sessions
(face-to-face and telephone counselling). Men in less intensive group (CG) received the same
booklet and free NRT as IG but no counselling sessions. The difference in outcomes among daily
smokers (DS) and non-daily smokers (NDS) were also assessed. For the 7-day and 30-day point
prevalence abstinence, at both time points in both groups, the abstinence rate were high and it was
higher in 12-month post-randomisation than end of pregnancy in both groups. No arm differences
were detected related to the intensity of the intervention. Arm differences for DS though were not
significant but favoured the more intensive arm .
2.4.1 Recruitment methods
Stanton et al. (2004), McBride et al. (2004) and Pollak et al. (2015) recruited eligible men
via their pregnant partners. Loke & Lam (2005) recruited women when they attended the first visit
of health care centre. de Vries et al. (2006) recruited women also during the first consultation in
clinic. In Oien et al. (2008), men were not individually consented in recruitment. Direct or indirect
recruitment of smoking men may have underlying difference in: (1) the level of motivation to quit/
change smoking behaviour/ needs of men which may prevent the optimisation of the intervention
effect since the format of intervention may not match with partners’ needs; and (2) perception of
partners’ willingness of participation by women which may cause loss of potential subjects that
could not be recruited due to women’s personal refusal in participation.
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2.4.2 Methodological issues
Five studies were randomised control led trial (Stanton et al., 2004; McBride et al., 2004; de
Vries et al., 2006; Loke & Lam, 2005; Pollak et al., 2015). Oien et al. (2008) was cohort control
trial. Among those RCTs, only Loke & Lam (2005) mentioned how they randomized the subjects
(subjects were randomised by serially labelled sealed envelop opened by a doctor). Stanton et al.
(2004), McBride et al. (2004) and Loke & Lam (2005) used intention-to-treat (ITT) analysis while
the remaining studies did not. Stanton et al. (2004) (∝=0.05 with >90% power to detect 10%
difference), de Vries et al. (2006) (∝=0.05 with power= 0.8 ; Loke & Lam (2005) and Pollak et al.
(2015) were sufficiently powered; Oien et al. (2008) and de Vires et al. (2005) did not show the
power calculation. For concealment method, Loke & Lam (2005) mentioned about randomising
participants with a serially labelled and sealed envelop. In Stanton et al. (2004), subjects were
blinded to group allocation (they were stratified by staff not involving in recruitment or interview
process). Pollak et al. (2015) randomised participants by a pre-set list without explaining how the
pre-set list was prepared. The remaining 3 studies did not mention about the concealment method.
2.4.3 Method in delivering the interventions and level of its exposure by smoking partners
Three studies involved both the pregnant women and their partners (Oien et al., 2008;
McBride et al., 2004; Pollak et al., 2015) with different level of exposure to the interventions by
men. In Oien et al. (2008), it did not state how many pregnant women brought their smoking
partners to the consultations. Positive results cannot be concluded being caused by the couple-based
consultation effect to what extend. In McBride et al. (2004), it did not state the portion of partner
who actually had used the nicotine patches, read the self-help cessation guides and been delivered
counselling. The effects cannot be exclusively concluded to be affected by these individual
intervention elements or the couple-based interventions. Pollak et al. (2015) found no difference in
all outcomes between
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the more intensive cessation (IG) and the less intensive one (CG) and they stated the use of NRT in
IG was higher (41% vs 28%).
Two studies directed at pregnant women and conveyed the cessation message through
pregnant women to their smoking partners (de Vries et al., 2006; Loke & Lam, 2005). de Vries et al.
(2006) reported that 76.2% of women in IG giving their partner the specialised booklet and less
than half of the men who received that had read it. The insignificant difference in partners’ smoking
behaviour may be caused by the low exposure to the indirect interventions. Loke & Lam (2005) did
not show data of how extensive the pregnant women used the strategies learnt to help their
husbands to quit. Stanton et al. (2004) was the only study delivering intervention towards men
directly. Thus, the effects of the interventions on the outcomes were more conclusive. The only
drawback was individual influence posed by video, nicotine patches, support materials on the
outcomes were not known.
2.4.4 Types of interventions components
Booklet/supporting written materials were used in 4 studies (Stanton et al., 2004; McBride
et al., 2005; de Vries et al., 2006; Pollak et al., 2015); NRT was included in 3 studies (Stanton et al.,
2004; McBride et al., 2005; Pollak et al., 2015) and so as counselling (Oien et al., 2008; McBride et
al., 2005; Pollak et al., 2015); video was only used in Stanton et al. (2004). Loke & Lam (2005)
depended on how the pregnant women demonstrated the skills they learnt through the advice,
booklet, brief health reminders on their smoking partners.
Stanton et al. (2004) had three types of written materials delivered to men; McBride et al.
(2004) had one self-help guide; de Vries et al. (2006) had one booklet outlined the smoking
influence with quitting suggestions but less than half of those who received the booklet had read it;
Pollak et al. (2015) delivered a booklet to men (for those who could not read, staff briefly discussed
the elements for these participants). None of them had assessed the satisfaction of the users for
12
these written materials and cannot draw exclusive conclusion about the effectiveness of these
materials.
Stanton et al. (2004) provided 1 week’s supply of NRT and prescription for further 3 week
supply; McBride et al. (2004) did not state how many NRT products were delivered. These 2 studies
did not state how extensively the men used NRT as a cessation method. Pollak et al. (2015)
supplied up to 6 weeks of free NRT samples and it stated more men in IG used NRT. Individual
effect of NRT of the outcomes cannot be concluded.
For the counselling, motivational interviewing techniques (MI) was used in McBride et al.
(2004); USPHS guideline “Treating Tobacco Use and Dependence. Clinical Practice
Guideline” (Fiore, Bailet, Cohen et al., 2000) which includes “5A’s model” were used in Oien et al.
(2008); Social Cognitive Theory, teachable moment model, MI and Cognitive-Behavioural Couple
Therapy were used were used in Pollak et al. (2015). Majority of the counsellors were trained for
the counselling techniques. McBride et al. (2004) had continuous supervision of the counselling but
did not state how. Pollak et al. (2015) recorded all of the counselling sessions and clinical
supervisors listened to the first 3 cases of each counsellor and chose randomly 10% of the cases to
review and provide comments to minimise drift. Oien et al. (2008) provided 3 hours training course
to the HCP which were lower than 40-hour training in the other 2 studies. Also, it did not state
whether it had ongoing assessment of the quality of counselling sessions.
Only Stanton et al. (2004) gave video to smoking men as part of the intervention. It did not
state the compliance of subjects in watching the video. It poses uncertainty in the effect of this
element contributing to the outcome.
2.4.5 Result of studies
Four studies showed positive effect in the smoking prevalence of smoking expectant fathers
(McBride et al., 2004; Stanton et al., 2004; Loke & Lam, 2005;Oien et al., 2008). de Vries et al.
13
(2006) shown no significant change in smoking partners; Pollak et al.(2015) stated that the quit rate
was high, only no arm difference between IG and CG. However, no reference quit rate was stated
for commenting whether the measured quit rate was really high. Also, no p-value was stated for the
arm differences significancy.
Oien et al.(2008) achieved positive effect on lower smoking prevalence in IG 6-week PN;
Stanton et al.(2004) achieved positive effect in higher quit rate in IG at 6-week PM; McBride et al.
(2004) achieved positive effect in partner cessation in PA than in UC at 28-week gestation only;
Loke & Lam (2005) achieved positive effect in no. of attempts in quitting in the past 7 days and
abstinence from cigarettes in the past 7 days at 1 month within the end of pregnancy. Short-term
outcomes were achieved but lack of prove in the sustainability of the smoking cessation
intervention. McBride et al.(2004) did not state the p-value of the difference between PA,UC,WO in
partners’ cessation rate in all postpartum time points. Judgement cannot be made whether any one
of the groups (PA/UC/WO) posing positive effect in sustaining the abstinence in cessation. For
Stanton et al.(2004), it only assessed the smoking status 6-month after the baseline interview for
once. Sustainability was not investigated. Loke & Lam (2005) assessed the abstinence for 1 month
or longer. Though IG had higher abstinence rate than CG (6.1% vs 4.2%) but was insignificant
(p=0.26). It may be due to the insufficient statistical power in detecting this small difference of this
study.
2.4.6 Outcome measurement methods
Three studies used the self-report of smoking status (Oien et al., 2008; McBride et al. 2004;
de Vries et al. 2006): 1 was reported by women for their partners (Loke & Lam, 2005) and 2 used
self-report with biochemical validation (Stanton et al. 2004; Pollak et al. 2015). Using self-report
may give rise to bias of the results. In the systematic review done by Connor Gorber et al. (2009),
the overall data shown underestimation of smoking prevalence and various sensitivity levels when
14
biological sample was obtained in validating the smoking status. However, according to Tennekoon
& Resenman (2013), biochemical assessment may not be superior to self-report method. The errors
in self-reported date was 3.22% while that of cotinine-based results were 3.27%. They suggested to
correct the self-report data statistically to cancel the bias instead of using biochemical method
which had potential to be unreliable. Also, proxy-reports may also cause underreporting of the
smoking behaviours. Interview method, race, participants and survey characteristics also affect the
data quality (Soulakova & Crockett, 2014). Respondents’ cognitive and motivational processes
when answering smoking-related questions, social desirability bias and gender effect also influence
the quality of the data obtained (Soulakova, Hartman, Liu et al., 2012). Oien et al. (2008) stated
reason in choosing self-reported method (similar reliability between interviews and questionnaire,
Norwegian validation study shown promising reliability of self-report by pregnant women,
biochemical methods were not feasible in this large epidemiological study). de Vries et al. (2006)
originally planned to biochemically validating the result but failed due to logistic problem. McBride
et al. (2004) did not state the reason of choosing self-report over biomarker or a combination of
both. Loke & Lam (2005) stated that the proxy-reporting was demonstrated as reliable in other
studies involving Chinese population conducted in 1994/ 1997. More up-to-date studies could be
cited in supporting their choice.
The performance of breath carbon monoxide (CO) and cotinine (COT) level in detecting
smoking status are different and COT is still better (Gariti, Alterman, Ehrman et al., 2002; Marrone,
Paulpillai, Evans et al., 2010). CO test is cheaper, faster and more readily accessible, but only
detects recent smoking; COT does not distinguish between smoking and use of NRT products, it is
more sensitive and specific (West, Hajek, Stead & Stapleton, 2005). In Stanton et al. (2004), only
quit rate but not abstinence was measured, CO test was appropriate. However, they only had the CO
test for some participants who agreed to be tested. Those who refused were counted as smokers.
15
The results would be more persuasive if all of the subjects were examined. In Pollak et al. (2015),
7-day point abstinence was validated by COT saliva level but not for 30-day abstinence which may
posed uncertainty on outcomes.
2.5 Conclusion
Providing smoking expectant father smoking cessation intervention at the time of
confirmation of pregnancy and at time right after delivery of baby are “teachable moment”. The
format can be (1) directed at men only; (2) directed at pregnant women to pose indirect influence on
men or; (3) directed at both the women and men.
Stanton et al. (2004) was the only one directed at men solely and its positive effects on
enhancing the quit rate at 6-week PN with validation of the self-reported result by biochemical
method were persuasive. The only question was whether the abstinence was sustainable.
For format (2), de Vries et al. (2006) found no significant difference in partners’ smoking
status at 6-week PN. The possible reasons were low-rate of partners exposed to the intervention and
utilisation of proxy-report to measure the outcome. Loke & Lam (2005) only delivered intervention
to pregnant women and without knowing how much of the intervention skills were used upon their
smoking husbands. Short-term abstinence effect was obtained. However, considering that it may be
difficult to involve men regularly during pregnancy due to work life, indirect format can be
considered to increase the probability of smoking partners to be exposed in certain amount of
smoking cessation intervention. Looking into the quality and quantity of intervention skills the
pregnant women executed throughout the process may increase the chance of generating reliable
positive outcomes.
For format (3), Oien et al. (2008) shown positive result in lower smoking prevalence of men
at 6-week PN. However, due to the time lapse between IG and CG (cohort study) and unknown
exposure of the intervention to the male participants posed uncertainty in the positive outcomes. In
16
McBride et al. (2004), smoking partners received calls in educating them to provide support to
partners and delivering stage-match counselling, self-help guides and free NRT. It shown significant
abstinence in short-term. Supportive interaction between couples may be one of the keys in shaping
the couple-based intervention. Pollak et al. (2015) aimed at investigating the intensiveness required
in obtaining positive effect in changing expectant fathers smoking behaviour, with showing
comparison in DS and NDS. This study used the self-report results validated by biomarker and
ongoing assessment of the quality of counselling sessions. Insignificant arm differences actually
means even a less intensive intervention being able to reach similar outcome as the more intensive
one. It also raised up the possibility that DS and NDS might need different intensity of intervention.
This provided a new aspect in shaping the innovation.
The dosage (intensity), components, format of the cessation interventions and outcomes
varied in the above studies. Nevertheless, from the studies, it was found that:
(1) personal needs of participants should be reached;
(2) couple interaction may be key in changing the smoking status;
(3) short-term positive effects are achievable but sustainability should be considered;
(4) the need of validation smoking status;
(5) regular quality control of the delivery of intervention by HCP should be done to
maintain/ improve the effectiveness;
(6) feedback from users about the intervention materials should be obtained;
(7) different resources such as video, written materials, telephone counselling
etc. can be used to increase the exposure of smoking partners to cessation interventions
without overwhelmingly increasing the workload of the busy clinical setting.
In view of the notorious influence of smoking towards the pregnant women, fetus and the
smoking partners themselves, healthcare expenditure and lack of such service in Hong Kong,
17
evidence-based protocol should be developed with reference to the above studies in order to
generate a suitable guideline for Hong Kong clinical setting.
18
Chapter 3: Implementation Potential and Clinical Guideline
In the last chapter, positive effects were achievable by implementing cessation interventions
for the expectant fathers (directly or indirectly). With various ways in delivering such cessation
programme, an evidence-based practice (EBP) guideline should be developed for healthcare
professionals (HCPs) to standardise interventions. By extracting and integrating feasible elements
from the reviewed studies, with consideration of the actual clinical situation in Hong Kong, an EBP
guideline of smoking cessation for partners of pregnant women during antenatal (AN) and postnatal
(PN) period will be presented in the following sections.Also, the target audience and setting,
transferability and feasibility of the innovation, possible risks and benefits and budget plan will be
discussed in the following section.
3.1 Target audience and setting
Target audience will be smoking partners of pregnant women who have first AN registration
in public hospital. Target setting will be an acute public hospital under Hong Kong East Cluster
(HKEC). It is the first registration point of AN FU booking in HKEC.
3.2 Transferability
3.2.1Target setting
Five studies were conducted in developed countries (Australia, USA, Norway, Denmark)
and one conducted in China. As Hong Kong is well-developed socially and economically, with the
mixture of western and eastern culture, differences among the above countries and Hong Kong
would not be prominent. Target target hospital achieved full accreditation by Australian Council on
Healthcare Standards (ACHS) (Report on Pilot Scheme of Hospital Accreditation, 2014). The care
provided is up to international standard.
19
3.2.2 Target audience
All of the studies involved smoking partners of pregnant women with different definition of
“current smoker” (Stanton et al. (2004) recruited partners currently smoking at least ten cigarettes
per day within three days of the baseline interview, Pollak et al. (2015) recruited partners smoked at
least a hundred cigarettes in their lifetime and in the past 30 days, Loke & Lam (2005) recruited
partners smoking at least one cigarette per day, Oien et al. (2008) defined smokers as having at least
one cigarette per week, with the mean average of no.of cigarette/day of the participants were more
than eight, McBride et al. (2004) recruited partners who, by calculation, the daily consumption of
cigarette were more than one, de Vries et al. (2006) did not specify recruited partners’ smoking
frequency. By calculation, in general, the recruited participants were all daily smokers (at least 1
cigarette/ day).
About the characteristics of the smoking partners of pregnant women, in Pollak et al. (2015),
>60% of them were educated for ≦9 years and their mean age was 30; in Stanton et al. (2004), 90%
had only completed senior secondary school or below and aged from 16-56; 79.6% had education
level of upper secondary or below but did not state the age of the male (Lam & Loke, 2005); in
Oien et al. (2008), mean year of education received was about 15 years and did not state the age of
the male; no information were stated about the partners in de Vries et al. (2006); lastly, the mean
paternal age was 25 with no information about the education level in McBride et al. (2004). In
Hong Kong, 96% of no. of births given was within paternal age of 20-49 (Lam et al., 2013). 51% of
daily smokers fall into this age range (Census and Statistic Department, 2016). Around 51% of male
in this age range received upper secondary education and/ or below (Census and Statistic
Department, 2015). With similar age, higher education level of male in Hong Kong than the above
studies should make counselling and written materials less difficult to be understood. In the
proposed innovation, current male smokers (at least 1 cirgarette per day or have smoked in the past
30 days), aged 18 or above, partners of pregnant women under antenatal (AN) care of target
20
hospital and not currently participating in any smoking cessation service, would be recruited. The
transferability with regard to the characteristics of the target audience should be acceptable.
3.2.3 Philosophy of care
The innovation proposed is aimed to provide people-centered counselling so as to create
environment that promotes healthy family. The target hospital aims to “excel in the provision of
holistic people-centred quality care through love, dedication and teamwork” and a baby-friendly
hospital (Hospital Vision, Mission & Values, 2011). The philosophy of care of the innovation and
target hospital is coherent.
3.2.4 Adequacy of clients to benefit
There was no existing data about the no. of smoker who were the father of the infant given
birth to in target hospital, which has more than 3000 deliveries annually (Cheuk, Lo & Lee, 2015).
The no. of in-patient under Obstetrics in target hospital remained within 3000-4000 in the past 7
years (Annual Report - Alice Ho Miu Ling Nethersole Charity Foundation, 2009, 2010, 2011, 2012,
2013, 2014.). In the past year, every week there was around 60 new cases and 70 old cases FU in
target hospital, i.e. around 250 cases in month and 3000 cases in a year. From the data shown in the
part of “Target Audience”, given that smoking prevalence in Hong Kong was 10.5% of the total
population in 2015 (male daily smokers were accounted for 18.6% of it) (Census and Statistic
Department, 2016), it was estimated around 60 - 80 smoking fathers per year would be eligible for
the suggested innovation. Changing the smoking habit of the male partners can bring benefits not
only to themselves but also the expectant mothers and the yet-to-born fetus, there should be
sufficient clients to benefit from the innovation.
21
3.2.5 Implementation and evaluation time
The proposed innovation would be started at around 12th gestation week of the registered
pregnant women, ongoing through the gestation period until 2 months PN, in total 8 months and 2
weeks to complete the whole cessation progress (considering normal full-term delivery at 38th
gestational week). Recruitment period for participants would be 12 months. Thus, including the last
lot of participants, cessation part would need 20 months and 2 weeks to complete. Plus the PN
telephone FU (6 months after the last cessation FU), the whole innovation would need 26 months
and 2 weeks to complete.
To predict the no. of recruitable targets, data of the number, age, education level, job nature
of male partner smokers in the last 12 months of target hospital would first be analysed. This
process may take 2 weeks. Meanwhile, design of record and forms would be in progress. Then,
introduction and training of the innovation for HCPs including nurses and doctors in Obstetrics &
Gynaecology (O&G) Day Ward 7 (D7), PN ward and SOPD would be delivered by the staff of
cessation clinic of target hospital. The proposed training duration would be a 2-session course (4
hours per session), with different time slots within the 10-day training period for the convenience of
manpower distribution. Afterwards, pilot trial would be proceeded and be finished within 8 weeks
plus 2-week evaluation before formal launching (details would be explained in Chapter 5). After
formal launching, evaluation meetings would be held 1 month and every 2 months afterwards. 2
more weeks would be used for final data analysis post-innovation. The data analysis, development
of documents, training, pilot trial, implementation and evaluation time frame are reasonable.
3.3 Feasibility
3.3.1 Freedom to implement
The involved HCPs including nurses and doctors would have the freedom to carry out and/
or terminate the innovation based on the desirability of the programme. Evaluation meetings would
22
be held and opinion from various parties would be collected to ensure the innovation is desirable to
be executed in the clinical working area. HCPs are trained professionally with adequate critical
thinking and clinical knowledge to make appropriate judgement towards the actual situation and
thus they would have authority to continue or terminate the innovation if it is considered as
undesirable.
3.3.2 Interference with current functions
Since telephone counselling is included in the innovation, more manpower has to be
distributed for calling participants to deliver counselling. Also, each D7 FU has face-to-face
counselling session which would lengthen the consultation time. Moreover, technically, the
expectant fathers are not patients under O&G department of target hospital. Some formal medical
documents e.g. referral letter and Nicotine replacement therapy (NRT) may not be able to provide
directly to those who need. Lastly, not all the women have PN FU at hospital but also MCHC or
Midwife Clinic (MC). An extra FU arranged back to the hospital after delivery would require more
SOPD sessions/ rooms for participated family.
3.3.3 Administration and organizational support
Leaders in administration and organization level of hospital may first be reluctant in
implementing such innovation which requires more manpower and resources. With the availability
of smoking cessation services provided by other organisations, and a relatively low smoking
prevalence in Hong Kong comparing to other countries, they may not see the reason in adding one
more within hospital. Therefore, evidence-based findings, cost-benefit and differences between this
target-specific innovation and other cessation services have to be stated clearly to strive for their
support and approval.
23
3.3.4 Consensus and friction among staff
Lack of time, training and confidence in providing smoking cessation counselling of HCPs
may generate friction in launching such innovation. Moreover, this innovation causes them to have
more workload and this may further weaken their willingness to carry out the programme. Adequate
resources and training should be provided to strengthen their confidence and skills of counselling
and awareness of the influence brought by smoking towards the participants’ family. Also,
evidence-based findings should be delivered to the involved HCPs to stress the importance of the
innovation. The before-mentioned opinion collection and evaluation meetings would be held
regularly to allow adjustment of innovation in order to suit the actual clinical environment.
3.3.5 Skills needed to implement intervention and staff development
Smoking cessation counselling skills are needed for the implementation of the innovation. In
my clinical working area, such training is insufficient. To enhance and standardised the counselling
components and skills, the cessation clinic under target hospital can be cooperated with for
providing training. The 8-hour training includes the smoking prevalence in Hong Kong, effects on
smoking and quitting towards smokers and their family (pregnant women and fetus), available
cessation treatments and counselling components. HCPs would be trained for: 5A’s, 5R’s,
Motivational Interviewing (MI). The training requires 2 nurses from cessation clinic. Training
would be carried out within 10 days to cover all involved HCPs.
3.3.6 Facilities available to implement the intervention
For AN FU, the usual consultation rooms would be enough since counselling is set to be
implemented during regular FU. For post-delivery counselling, it can be done at bedside or
interview room in PN ward, together with routine discharge procedure. For PN FU counselling,
more FU quotas and consultation rooms are needed. Also, telephone system is needed for telephone
24
counselling and hotline enquiry. Extra forms and documentation notes should be prepared for
counselling records. Self-help cessation guide and video for participants is also needed to be
prepared.
3.3.7 Evaluation tools available
Baseline smoking status would be collected at the first counselling session. In every face-to-
face and telephone counselling, smoking status, 7-day and 30-day point abstinence, no. of cigarette/
day and no. of quit attempt would be asked. Self-reported would be used as the evaluation method.
If participants do not attend the face-to-face session, proxy-report would also be accepted. Self-
reported method was used in Orien et al. (2008), McBride et al. (2004) and de Vries et al. (2006)
and proxy-report method was used in Loke & Lam (2005). Self-report method is a reliable,
convenient and cost-effective verification of smoking status (Yeager & Krosnick, 2010; Kormos &
Gifford, 2014). Spousal proxy report was regarded as a feasible and reliable method (Mak et al.,
2005). Also, as stated in Chapter 1, biochemical assessment may not be superior to self-report
method (Tennekoon & Resenan, 2013). Considering the busy clinical environment, self- and proxy-
report may alleviate the workload of HCPs.
3.3.8 Cost-benefit ratio of the innovation
Potential risk:
(a) To target participants’ family: There were no specific risks mentioned in the
reviewed studies. However, in Pollak et al. (2015) and McBride et al. (2004),
communication and support between partners were discussed. In Pollak et al. (2015),
communication skills for understanding partners’ barriers and showing support for
changing smoking habit were included in the counsellors’ agenda. In McBride et al.
(2004), authors also revealed that men had difficulty in thinking how their actions
25
(b) may influence the relationship. These imply that relationship between couples when
involving in the cessation together may have fluctuation, which could be caused by
the difference of the perceived support shown or perceived effort paid by the couples
in the process of smoking cessation.
(c) To the hospital: Extra workload are inevitable for launching the innovation for all
related staff. Regular evaluation, meetings, report of effectiveness and routes for
providing comments by staff would be available to ensure their work and opinions
are appreciated and respected.
Potential benefits:
(a) To target participants: Stop smoking at any age decrease risk of diseases e.g. cancer
and cardiovascular diseases (CVD) (Centers for Disease Control and Prevention
(CDC), 2015). Also, it was estimated by the research done by the Chinese University
of Hong Kong that Hong Kong smokers would spend more than HKD$1 million on
tobacco products in their lifetime (smoke 1 pack per day) (Communications and
Public Relations Office, 2015). Quitting smoking causes less ]tobacco products
expenditure.
(b) To target participants’ family: Lower exposure to second-hand smoke (SHS) by
pregnant women, fetus and any other co-living family members reduces their risks in
getting CVD, cancer, Sudden Infant Death (SID), respiratory problems (CDC, 2014).
(c) To Hong Kong medical system and other aspects: As mentioned in Chapter 1,
hospitalisation and outpatient consultation caused by SHS exposure of pregnant
women and fetus costed millions expenditure of our medical system; the total direct
health care and long term care costs due to smoking reached more than $3500
million annually; the grand total of health related costs to our community were more
26
(d) than $5 billion per year; productivity loss due to active and passive smoking costed
$1773 million per year (McGhee et al., 2005). This innovation directs at expectant
fathers but affects their whole households. Financial burden to our medical system
due to active and passive smoking could be improved.
3.3.9 Costs
Details of expenditure are illustrated in Appendix 4.
3.4 EBP Guideline
The EBP guideline of the innovation is presented in Appendix 6. Development of such
guideline was based on the literature review done in Chapter 1. The recommendations generated
were graded according to Grades of Recommendations (Scottish Intercollegiate Guidelines
Network (SIGN), 2012) in Appendix 5.
27
Chapter 4: Implementation Plan
After development of an evidence-based practice (EBP) guideline, gaining support from
different parties involved would be the utmost important agenda for the approval of this
programme. Related stakeholders and the communication strategies would be elaborated as follow.
Details of pilot study for the proposed programme and evaluation plan would also be described in
the following sections. The overall timetable is shown in Appendix 7.
4.1 Communication plan with stakeholders and potential users
Stakeholders are those who would affect or be affected by the proposed programme. To
communicate with these essential personnel would catalyse the establishment of the programme
with positive results through smooth cooperation. The stakeholders identified are administrative
level staff and frontline staff from the hospital, O&G department and Smoking Cessation Clinic
(SCC). Timetable was shown in Appendix 8.
4.1.1 Communication with administrative level stakeholders
Administrative level stakeholders include Hospital Chief Executive (HCE), General
Manager of Nursing (GMN), O&G Chief of Service (COS), O&G Department Operation Manager
(DOM) and the In-charge (IC) of SCC . Top-down approach would be used. It is said to be efficient
to implement changes which need continuous high-level of support from senior management level
(Jabri, 2012). An email enclosed with the details of innovation would be sent to the above named
stakeholders. They would be invited to attend a formal presentation in week 1. The affirming needs,
objectives and significance, literature research results, transferability, feasibility, resources needed
and the proposed EBP guidelines would be presented. A printed version of the proposal would be
given prior to the meeting. We plan to gain feedback and approval from administrative level within
2 weeks, with continuous communication in between. In week 5, after communications with
28
different parties, formation of working group and the review of EBP guideline, administrative
stakeholders would be contacted again to get final approval. Recognising and rewarding workers’
effort and performances are important to maintain positive working behaviour and attitudes (De
Gieter & Hofmans, 2015). Reward such as compliments or appreciation are specially prominent to
keep employees motivated (Hofmans, De Gieter & Pepermans, 2013). In order to attract staff to
join (being trainers and trainees), we would propose methods to the administrative stakeholders to
recognise the efforts of the participated staff, e.g. certificates, approved as recognised items to be
included in Staff Development Record (SDR).
4.1.2 Communication with middle-level staff
Involving the middle-level staff to act as active participants can empower the planning
process by catalysing horizontal collaboration with the vision of senior management level (Jabri,
2012). In week 2, after gaining support from the administrative level, a formal meeting would be
held with the O&G Associate Consultants (AC), Ward Managers (WM) and Nursing Officers (NO)/
Advance Practice Nurses (APN) and representative from SCC. Same presentation would be
delivered and explain the support and resources the programme needed from them if possible,
especially their unique position between the senior management and frontline staff in order to build
up effective two-way communication.
4.1.3 Communication with frontline staff
Frontline staff include nurses, Medical Officers (MO) working in the O&G department. The
innovation would be presented in the O&G regular nurses’ meeting and doctors’ meeting. Every
participant would be given a set of the presentation slides and questionnaire (Appendix 9) , which
would be collected back during week 3 & 4.
29
4.1.4 Formation of working group
During week 2, we would invite senior and middle-level staff who are interested in joining
the preliminary task force. By promoting the innovation through personal communication and
formal presentations during nurses and doctors meetings, we would also recruit frontline staff to
join the working group. Ideally, the working group would have the proposer, 1 AC , 1-2 MOs, 5
NOs/APNs (1 from each ward), nurses (at least 1 from each ward) and representative from SCC (1).
The group would be formed by week 3. Group members would be responsible for collecting
opinions; communicate with related parties; organising training, pilot trial and evaluation meetings.
4.1.5 Communication with public
After the final approval from administrative level, working group would work on the
promotion of such programme towards the target audiences i.e. pregnant women and their smoking
husbands (would be named as “clients” in the following). By means of posters, playing promotion
video at the waiting area of the hospital, leaflets at SCC and the registration counter etc. would be
used to gain target audiences’ attention. Front desk staff in SCC, SOPD and registration counter
would also be notified about such innovation in case of enquiries from public.
4.2 Pilot Test
Since the whole programme originally involves a long time for clients (starting at around
12th gestation week of the registered pregnant women, ongoing through the gestation period until 2
months PN, in total 8 months and 2 weeks to complete the whole cessation progress for one
husband), a simplified version of the cessation programme would be carried out. Those joining for
at AN stage would not have PN cessation FU; those being recruited at PN stage would only receive
counselling in PN ward upon discharge with phone FU. Timeline for pilot test is shown in Appendix
10.
30
4.2.1 Aims
Pilot test are aimed to test:
(1) the feasibility of the process of target recruitment, cessation counselling session (face-to-
face & telephone) and evaluation strategies;
(2) the acceptability of guideline users and participants;
(3) the effectiveness.
4.2.2 Details of pilot test
The pilot test would be done within 2 months. In week 8-10, we would recruit clients whose
wives (A) register for their first AN FU at the SOPD counter; or (B) register for PN FU at the
SOPD counter; or (C) have already delivered in PN ward. Baseline characteristics (age, education
level, job, smoking status, no. of cigarette/day, experiences of cessation (quit attempts), household
information) of the clients and their wives would be obtained.
For (A), on the day of the pregnant women having USG examination in D7, one smoking
counselling would be provided for the clients. For (B), one smoking counselling would be provided
for the clients upon discharge; for (C), one smoking counselling session would be provided . All of
them including the wives would be given a set of self-help kit (Appendix 11). For (A), (B) & (C), 1
week after the face-to-face counselling, one telephone counselling would be delivered. If clients do
not show up for the face-to-face session, cessation education would be delivered to wives with both
self-help kits given to them. They would be reminded to give their smoking partners the Self-help
kit.
31
4.2.3 Evaluation
Feasibility
In week 12, focus-group interview with nurses and doctors involved would be held.
Interview would mainly focus topics such as barriers encountered, workload, compliance to the
EBP guideline, interference with daily routine etc. A questionnaire (Appendix 12) would be given
to all staff at the end of the pilot test. All wards would be required to record any extra expenditure
spending on this programme. Representative from SCC would randomly pick cases from the
participant list and observe the counselling process (both face-to-face and phone). They would
provide feedback about the counselling quality.
Acceptability
For the guideline users, opinions about the guideline would be asked during the focus-group
interview and in the questionnaire. For clients and their partners, 1 week after the phone
counselling, we would call them to evaluate the pilot programme (standardised questions are shown
in Appendix 13). For those who do not accept our call, a questionnaire with the same questions in
Appendix 13 would be sent to their address.
Effectiveness
In every counselling session, self-report smoking status, 7-day, 30-day point prevalence
smoking abstinence, no.of cigarette smoked per day (if they are still smokers) and quit attempts
would be asked. Proxy-report would also be accepted if the clients do not show up. The result
would be compared with the baseline data collected. Those who are lost to FU/ do not disclose their
smoking status would be regarded as smokers.
After integrating the results of evaluation from different parties, a meeting would be held to
present the evaluation details, exchange opinions and provide feedbacks to adjust the EBP
32
guideline. O&G nurses, doctors, WMs, DOM, COS and SCC trainers would be invited to this
meeting.
33
Chapter 5: Evaluation Plan
To assess the effectiveness and efficacy of the proposed innovation, an evaluation plan is
needed to analyse the outcomes and generate useful information to further adjust or develop new
components for the programme to be beneficial. Measurements of identified outcomes, nature and
no. of target clients, data analysis and basis for determination of the effectiveness of innovation
would be elaborated in the followings.
5.1 Outcomes identified and measurements
Three categories of outcome were identified: clients’ outcomes, staff outcomes and system
outcomes. Evaluation methods would be explained under each categories.
5.1.1 Clients’ outcomes and evaluation
For patients’ outcomes, self-report/proxy report abstinence and changes of smoking habit
would be assessed. Primary outcome would be 7-day point prevalence abstinence. Secondary
outcomes would be 30-day point prevalence abstinence (longer term effect), no. of quit attempts
and no. of cigarette taken per day. In the table below, definitions of each outcome were stated:
At the end of the last cessation session, satisfaction towards the programme of clients and their
partners would be assessed by using a 5 Likert type scale questionnaire (Appendix 13).
Outcome Definition Categories (self-report/ proxy-report)
7-day point prevalence abstinence Never smoke even one puff of cigarette in the past 7 days “Yes”/ “No or lost to FU”
30-day point prevalence abstinence
Never smoke even one puff of cigarette in the past 30 days “Yes”/ “No or lost to FU”
No. of quit attempts Attempt to quit smoking ≧24-hour in the past 4 weeks
“None or lost to FU”/ “1-2 times”/“3-4 times”/ “≧5 times”
No. of cigarette taken per day No. of cigarette taken per day in the past 4 weeks
“0-5”/ “6-10”/ “11-15”/ “15-20”/ “≧20”/ “Unknown/ Lost to FU”
34
On the day of the first counselling session, baseline information of the clients and their
wives would be obtained: age, education level, job, smoking status, no. of cigarette/day, experiences
of cessation (quit attempts), household information. In the following cessation counselling sessions
(face-to-face and telephone, timeline in Appendix 14), clients would be asked for the smoking
status, 7-day and 30-day point prevalence abstinence, no. of cigarette/day and no. of quit attempt.
Both self-report or proxy-report data would be accepted. According to the timeline, at gestational
week 12, 16, 24, 38(upon discharge from PN ward), 4 weeks PN and 8 weeks PN would be the time
for collecting the above data. In the literatures reviewed, it was stated that pregnancy and also PN
period (seeing the actual babies) could be the teachable moment for smoking cessation (Oien et al.,
2008 [+]; Stanton et al., 2004 [+]& Pollak et al., 2015 [+]) collecting data from these three time-
spots would be suitable to evaluate the innovation.
To calculate the required sample size, G*Power version 3.1 was used. In the calculation, the
most conservative data was used to generate the least no. of sample required for the effectiveness.
From McBride et al. (2004), 7-day point abstinence prevalence of smoking husbands in PA vs UC
was 15% vs 5% ( x2= 5.11, p=0.02); for Loke & Lam (2005), 7-day point abstinence prevalence of
smoking husbands in intervention group vs control group is 8.4% vs 4.8% ( x2=4.1, p=0.04). The
more conservative data was used, i.e. data from Loke & Lam (2005). By using Chi-square and A
priori as the power analysis, for a level of significance = 5% and power=80%, 277 subjects were
required as the sample size. With consideration of clients’ dropout rate during the programme, an
intention-to-treat approach will be used for the analysis.
5.1.2 Staff outcomes and evaluation
“Satisfaction”, “compliance” and “skill, knowledge & confidence” of staff for this
programme would be assessed. For the first two components, a set of questionnaire (Appendix 12)
would be distributed to staff at the end of the programme. For the third component, questionnaire
35
(Appendix 15) would be before the training, after the training, and at the end of the programme. All
the questionnaires were in 5 Likert type scale format.
5.1.3 System outcomes and evaluation
Total expenditures used in this programme should be documented during the
implementation. Every 3 months, we would collect expenditure records from every ward and
related department. Also, extracting data about the medical expenditure caused by passive-smoking
of pregnant women and fetus in the period of implementation should be done to evaluate the effect
of this programme on reducing financial burden to the medical system. This should be done by
obtaining approval from administrative management level to gain assess of such data. The change
in the no. of cigarette smoked would be used to estimate the change in expenditure for cigarette of
the participants.
5.2 Data Analysis
Data analysis would be performed using SPSS version 22.0. Descriptive analysis would be
used for the demographic data of the subjects and also the satisfactory level of subjects and staff.
Using the intention-to-treat principle, primary and secondary outcomes would be analysed using the
two-tailed paired-samples t-test with the level of significance at 0.05. For staff outcomes, mean
scores of each question of the questionnaire would be analysed to evaluate change of the skill,
knowledge and confidence in smoking cessation counselling pre-implementation and post-
implementation.
5.3 Determination of effectiveness
To determine the effectiveness of the innovation, primary outcome would be the main
indication. 7-day point prevalence abstinence was one of the outcomes in McBride et al. (2004) [+]
36
(15%, p=0.02), Loke & Lam (2005) [+] (8.4%, p=0.04) and Pollak et al. [+] (2015) (ranged from
30%-39% at all time points for both intensive-intervention and less-intensive-intervention group,
adjusted OR= 0.96 [at the end of pregnancy] and -1.02 [12-month postrandomization], both at 95%
CI). The significant positive result in McBride et al. (2004) and Loke & Lam (2005) were at AN
period only; Pollak et al. (2015) still had ≧38% of abstinence at both time points and both groups
12-months post-randomisation. The innovation involved a mixture of the intervention strategies of
these three studies (cessation directly at men, indirected by women and couple-based counselling).
However, there was no similar studies about quit rate of expectant fathers in Hong Kong as
reference. The only similar data about 7-day point prevalence abstinence after cessation service in
Hong Kong was 27%, with the subjects were general public but not expectant fathers (Abdullah et
al., 2004). In view of cultural difference, similarities and intensity of the intervention combination
and the unknown strength of influence of the innovation on expectant fathers in Hong Kong, the
basis would be set at a more conservative level at 15%. Thus, if the 7-day point prevalence of
abstinence of the participants ≧15% at the end of the innovation (8 weeks PN), this programme
could be regarded as successful.
37
Chapter 6: Conclusion
Smoking damages health of smokers but also the people around them. A smoking cessation
programme specialised for expectant and newborn’s fathers could help to protect the health of the
pregnant women, fetus and the infants. After reviewing relevant literatures, an innovation and EBP
guideline were developed for HCP to deliver strategies to target clients in the Hong Kong clinical
setting, in hope of improving the health of public, lowering medical expenditure and related
economic loss.
iv-1
Appendix 1 - SIGN level of evidence list
Level of evidence Explanation
1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias
1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias2++ High quality systematic reviews of case control or cohort or studies
High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causa
2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal
2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal
3 Non-analytic studies, e.g. case reports, case series4 Expert opinion
iv-2Appendix 2 - Table of Evidence
Loke, A.Y. & Lam , T.H. (2005). A randomized controlled trial of the simple advice given by obstetricians in Guangzhou, China, to non-smoking pregnant women to help their husbands quit smoking. Patient Education and Counseling, 59, 31-37.
Biliog-raphy citation
Study type (level of evidence)
Patient characteristics Interventions Control Length of follow-up
Outcome measures re-lated to smoking fa-thers
Effect size
Loke & Lam, 2005
RCT(1-)
Never-smoked pregnant women of whom the hus-bands were currently smok-ers and they lived in the same household
Intervention group (n=380):
1. Standardised advice from obstetrician about SHS exposure and importance in helping husbands to quit
2. Educational booklet teaching methods for helping subjects’ husbands to quit smoking
3. Brief health re-minders in subse-quent prenatal visits of action to be taken in preventing SHS and helping hus-bands to quit
Control group (n=378):
Received no inter-ventions as usual in prenatal clinics
7 months Primary outcome: 1. Abstention from
cigarettes in the past 7 days
Secondary outcome: 1. Abstention for 1
month or longer (and total absten-tion in last 7 days)
2. No. of attempts to give up in the past 7 days
3. Change in the no. of cigarettes smoked per day in the last month of the pregnancy
Primary outcome: 1. IG>CG (8.4% vs 4.8%,
p=0.04) [OR=1.84, 95%CI, 1.01-3.34]
Secondary outcome: 1. IG>CG (6.1% vs 4.2%,
p=0.26, not statistically sig-nificant) [OR=1.46, 95%CI, 0.76-2.81]
2. IG >CG (30% vs 22.2%, p=0.003)
3. Reduced level of smoking: IG>CG (39.7% vs 17.7%, p<0.0001)Increased level of smoking:IG<CG (9.5% vs 11.6%, p<0.0001)
(IG=Intervention Group; CG= Control Group; OR= Odd ratio; CI= Confidence interval)
iv-2
Pollak, K.I., Lyna, P., Bilheimer, A.K., Gordon. K.C. et al. (2015). Efficacy of a Couple-Based Randomized Controlled Trial to Help Latino Fathers Quit Smoking during Preg-nancy and Postpartum: The Parejas Trial. Cancer Epidemiology, Biomarkers & Prevention, 24(2), 379-385.
Biliography citation
Study type (level of evidence)
Patient characteristics
Interventions Compare Length of follow-up
Outcome measures related to smoking fathers
Effect size (Effects were controlled for education, no. of cigarettes smoked per day and wontedness of pregnancy, with ORs with 95% CI)
Pollak, Lyna, Bilheimer et al. (2015)
RCT(1+)
(1) Non-smoking pregnant women, aged>16, between 13 weeks and 29 weeks gestation
(2) Husbands aged>16, smoked at least 100 cigarettes in their lifetime & in the past 30days
Materials +NRT +counseling [MNC] (n= 173):
1. Written material (booklet) for men
2. Up to 6 wks of free NRT for men (nicotine gum or patch)
3. 6 counselling sessions:3 for during pregnancy and 3 for postpartum (1 face-to-face for couples & 2 via phone for men only respectively)
(wks=weeks)
Materials+NRT-only [MN] (n= 175):
1. Written material (booklet) for men
2. Up to 6 wks of free NRT (nicotine gum or patch) for men
12 months
Primary outcome: 1. 7-day point
prevalence ab-stinence of men
Secondary out-come: 1. 30-day point
prevalence ab-stinence of men
2. Continuous ab-stinence of men
All were measured at the end of preg-nancy (EOP) and 12months postran-domization(12m-post)
Primary outcome: (a) MNC vs MN -
EOP:30%vs 31% [OR:0.96 95%CI 0.6-1.55]; 12m-post: 38% vs 39%[OR:0.-1.02 95%CI 0.65-1.60], high in both groups
(b) NS>DS at both time points, but no significant arm differences
(c) DS had higher 7-day cessation rate in MNC group than MN group(EOP: 16% vs 13%, 12m-post:24% vs 17%), but no significant arm difference.
(d) Higher in 12m-post than EOP in both groups (MNC:38% vs 30%; MN: 39% vs 31%)
Secondary outcome: 1. MNC vs MN -
at EOP:19% vs 14% [OR:1.42 95%CI 0.81-2.49]; at 12m-post: 30% vs 30%[OR:1.14 95%CI 0.78-1.84], high in both groups DS’s 30-day cessation rate- MNC>MN (at EOP: 9% vs 2%*; at 12m-post: 16% vs 9%[OR:2.12 95%CI 0.68-6.63]), no significant arm difference Higher in 12m-post than EOP in both groups (MNC:30% vs 19%; MN: 30% vs 14%)
2. No arm difference in continuous abstinence for NS and DS
(NS=Nondaily Smokers; DS Daily Smokers; CI = confidence interval) *OR:unable to model due to sample size
iv-2
de Vries, H., Bakker, M., Mullen, P.D. & van Breukelen, G. (2006). The effects of smoking cessation counseling by midwives on Dutch pregnant women and their partners. Pa-tient Education and Counselling, 63, 177-187.
Biliography citation
Study type (level of evidence)
Patient characteristics
Interventions Control Length of follow-up
Outcome measures related to smoking fathers
Effect size
de Vries et al. (2006)
RCT(1-)
1. Women pregnant not more than twice
2. Smoked at least one cigarette/day
Intervention group (n=141):
1. Video 2. Self-help guide 3. Booklet 4. Booklet made for
smoking partners 5. Health counselling
Control group (n=177):
Usual care plus a general folder from the Dutch Smoking and Health Foundation
6 weeks postpartum
Partners’ smoking status change
No significant difference (ps>0.30 at both time points)
iv-2
McBride, C.M., Baucom, D.H., Peterson, B.L., Pollak, K.I. et al. (2004). Prenatal and Postpartum Smoking Abstinence - A Partner-Assisted Approach. American Journal of Pre-ventative Medicine, 27, 232-238.
Biliography citation
Study type (level of evidence)
Patient characteristics
Interventions Control Length of follow-up
Outcome measures related to smoking fathers
Effect size
McBride et al., (2004)
RCT(1-)
1. Women aged ≧18yo at ≦20weeks pregnant
2. Current smokers or recent quitters (smoed in 30days prior to pregnancy but not smoking at intake)
3. Living with an intimate partner
Intervention group 1 - Women only [WO](n=192):
1. Received UC components
2. Late-pregnancy relapse-prevention kit (booklet & gift)
3. 6 counseling calls (3 in pregnancy & 3 in postpartum)
Intervention group 2 - Partner assisted [PA] (n=193):
1. Received WO components
2. Boooklet 3. Companion video 4. Partners received 6
separate calls 5. Smoking partners also
received self-help cessation guides, free nicotine patches if needed, stage-match counselling
Control group [UC] (n=198):
1. Provider advice to quit smoking
2. American Cancer Society’s self-help guide
12months 1. Women’s report of changes in smoking-spe-cific and general support
2. Partner cessation
1. Decline in positive partner support condition (p≦0.001); instrumental support(p<0.0001); emotional partner support (p<0.0001);U-shaped quadratic function for negative smoking-specific support (p<0.001)
2. PA>UC at 28wk gestation (15% vs 5%, p=0.02)
iv-2
Stanton, W.R., Lowe, J.B., Moffatt, J. & Del Mar, C.B. (2004). Randomised control trial of a smoking cessation intervention directed at men whose partners are pregnant. Preven-tive medicine, 38, 6-9.
Biliography citation
Study type (level of evidence)
Patient characteristics
Interventions Control Length of follow-up
Outcome measures related to smoking fathers
Effect size
Stanton et al. (2004)
RCT(1+)
1. Smoking male of pregnant partners <25weeks of gestation
2. Living with the pregnant partner
3. Current smoker of at least 10 cigarettes per day within 3 days of the baseline interview
Intervention group (n=291):
1. Video 2. Nicotine patches and
information pack 3. Support material
Control group (n=270):
1. Brochure providing contact for the smoking cessation options
6 weeks postpartum
Primary outcome: 1. Quit rate
Secondary outcome: 1. Predictors of smoking
cessation
Primary outcome: 1. IG>CG (16.5% vs 9.3%,
p=0.011, OR=0.52, 95%CI 0.031-0.85)
Secondary outcome: 1. Those who quit smoking were
more likely to be: Skilled workers (p=0.04, OR=1.6);having more quit attempts of 2 weeks or more in the last year (p=0.036, OR=1.2);having first cigarette in the morning later (p=0.006, OR=1.5)
(IG=Intervention Group; CG= Control Group)
iv-2
Oien, T., Storro, O., Jenssen, J.A. & Johnsen, R. (2008). The impact of a minimal smoking cessation intervention for pregnant women and their partners on perinatal smoking behaviour in primary health care: A real-life controlled study. BMC Public Health, 8, 325.
Biliography citation
Study type (level of evidence)
Patient characteristics Interventions Control Length of follow-up
Outcome measures related to smoking fathers
Effect size
Oien et al. (2008)
Cohort study(2-)
1. Smoking male of pregnant partners <25weeks of gestation
2. Living with the pregnant partner
3. Current smoker of at least 10 cigarettes per day within 3 days of the baseline interview
Intervention group (140 men):
1. Brief office inter-vention pro-gramme (1/6/2002-15/12/2004)
Cohort Control group (155 men):
1. Common, na-tionwide rec-ommended, advice on life-style, includ-ing smoking behaviour, following the routines each health-worker was familiar with at that time (1/9/2000-30/5/2002)
6 weeks Primary outcome: 1. Self-report smoking
prevalence at 6 weeks postnatal
Secondary outcome: 1. Parental indoor smoking
prevalence
Primary outcome: 1. Paternal: IG<CG (14.5%
vs 17.9%, p=0.05)
Secondary outcome: 1. IG<CG (5% vs 8%,
p=0.04)
(IG=Intervention Group; CG= Cohort control Group)
iv-3Appendix 3 - SIGNS checklist
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages) de Vries, H., Bakker, M., Mullen, P.D. & van Breukelen, G. (2006). The effects of smoking cessation counseling by midwives on Dutch pregnant women and their partners. Patient Education and Counselling, 63, 177-187.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider: 1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the
study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question ⬜ 2. Other reason ⬜ (please specify):
! S I G N
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question. Yes ✓
Can’t say ⬜No ⬜
1.2 The assignment of subjects to treatment groups is randomised. Yes ✓
Can’t say ⬜No ⬜
1.3 An adequate concealment method is used. Yes ⬜ No ⬜
Can’t say ✓ It did not mention about concealment method.
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.
Yes ⬜ No ⬜
Can’t say ✓It did not mention about blinding method.
1.5 The treatment and control groups are similar at the start of the trial. Yes ⬜
Can’t say ✓No ⬜
1.6 The only difference between groups is the treatment under investigation.
Yes ✓
Can’t say ⬜No ⬜
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Yes ⬜ No ✓Study failed to collect cotinine samples as biochemical validation of smoking status due to logistic problems and had to rely on objects’ self-report instead.
Can’t say ⬜
iv-31.8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was completed?
14.9% (intervention group) 11.3% (control group)
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
Yes ✓
Can’t say ⬜No ⬜ Does not apply ⬜
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes ✓ No ⬜No significant cluster variance was found; province was never predictive for all outcomes (p>0.2)
Can’t say ⬜ Does not apply⬜
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code as follows:
High quality (++)⬜
Acceptable (+)✓
Unacceptable – reject 0 ⬜
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Provided that the significant increase in 7-day abstinence during pregnancy and 6 weeks postpartum and continuous abstinence at 6 weeks post-intervention, with all subjects receiving counselling, 96% received video (68% watched it), 91% received self-help guide (82% read at least part of it), and generally good rating on the credibility, understandability, level of interest and attractiveness of the materials, it is certain that the overall effect was due to the intervention. However, only ~70% of women gave the booklet to their partners and <50% of receivers had read it. The insignificant in partners’ smoking status may be contributed by this.
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
It may be able to be applied to the patient group targeted by this guideline but it may differ by the prenatal care frequency and routine consultation scheduling difference between Netherland and Hong Kong.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
Authors found significant increase in the chances of 7-day abstinence during pregnancy and at 6 weeks postpartum, continuous abstinence at 6 weeks post-intervention. However, no significant effect of the intervention on pregnant women’s partners’ smoking behaviour, which may be due to the non-compliance in giving their partner the booklet and only 48.4% of those partners who received the booklet (76.2% of women reported handing the partner booklet to their partner) from the pregnant women had read it. Also, the result of husbands’ abstinence was reported by women (proxy-report). It would be better if it was reported by the husbands themselves (or even by biochemical validation). It was good that this study also tested the interaction between the treatment and other variants such as no. of daily cigarette intake & education level etc. that reveals predictability in smoking behaviour of different covariates that helps further adjustment in the delivery of intervention to different types of patients.
iv-3
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages) Loke, A.Y. & Lam , T.H. (2005). A randomized controlled trial of the simple advice given by obstetricians in Guangzhou, China, to non-smoking pregnant women to help their husbands quit smoking. Patient Education and Counseling, 59, 31-37.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider: 1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the
study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question ⬜ 2. Other reason ⬜ (please specify):
! S I G N
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question. Yes ✓
Can’t say ⬜No ⬜
1.2 The assignment of subjects to treatment groups is randomised. Yes ✓
Can’t say ⬜No ⬜
1.3 An adequate concealment method is used. Yes ✓ No ⬜ Subjects were randomized by doctor who opened a serially labelled and sealed envelope indicating the allocation.
Can’t say ⬜
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.
Yes ⬜ No ✓ Double blinding was impossible since the subjects’ records had to be labelled to ensure the doctors gave follow-up reminders to the intervention group.
Can’t say ⬜
1.5 The treatment and control groups are similar at the start of the trial. Yes ✓ Can’t say □
No ⬜
1.6 The only difference between groups is the treatment under investigation.
Yes ✓
Can’t say ⬜No ⬜
iv-31.7 All relevant outcomes are measured in a standard, valid and
reliable way. Yes ⬜ No ⬜
Can’t say ✓ Outcomes were measured by pre- & post-intervention questionnaire. This may lack validation of husbands’ smoking status, but the reliability of self-reporting was shown to be reliable to other study e.g. He et al. (1994).
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
29.2% (intervention group) 30.2% (control group)
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
Yes ✓
Can’t say ⬜No ⬜ Does not apply ⬜
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes ⬜
Can’t say ⬜
No ⬜ Does not apply ✓
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code as follows:
High quality (++)⬜
Acceptable (+)✓
Unacceptable – reject 0 ⬜
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
The result of “more husbands in intervention group had attempted to stop smoking”; “reduced no. of cigarettes smoked” and “had not smoked any cigarettes for the last 7 days before the completion of the questionnaire” were significant with the p= 0.02, <0.0001, =0.04 respectively. The interventions produced short-term effects which were statistically significant. The physicians were trained and given briefing with standardised advice briefed before the launch of the study, compared to the control group receiving no intervention at all, it is certain that the overall effect is due to the intervention.
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
Authors found that an “indirect” intervention produced short-term effects in causing smoking husband to give up smoking for 1 week with statistical significance. However, the insignificant difference in 1-month abstinence rate could be due to insufficient statistical power in detecting small difference and contamination between intervention and control group subjects since they may communication with each other in the clinic. In conclusion, authors stated that the result of this study shown that health care professionals should encourage women to ask their husbands to give up smoking as a strategy. However, how much the pregnant women demonstrated the smoking cessation intervention to their smoking husbands were not known. The level of exposure to the intervention by men causing this outcomes should be investigated. Also, proxy-report instead of self-report/ biomarkers validation of the smoking status was used and it may pose bias in the smoking behaviour. However, authors explained that the proxy-report in their population was reliable based on the past studies as prove.
iv-3
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages) McBride, C.M., Baucom, D.H., Peterson, B.L., Pollak, K.I. et al. (2004). Prenatal and Postpartum Smoking Abstinence - A Partner-Assisted Approach. American Journal of Preventative Medicine, 27, 232-238.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider: 1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the
study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question ⬜ 2. Other reason ⬜ (please specify):
! S I G N
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question. Yes ✓
Can’t say ⬜No ⬜
1.2 The assignment of subjects to treatment groups is randomised. Yes ✓
Can’t say ⬜No ⬜
1.3 An adequate concealment method is used. Yes ⬜ No ⬜
Can’t say ✓ It did not mention about concealment method.
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.
Yes ⬜ No ⬜
Can’t say ✓It did not mention about blinding method.
1.5 The treatment and control groups are similar at the start of the trial. Yes ✓
Can’t say ⬜
No ⬜
1.6 The only difference between groups is the treatment under investigation.
Yes ✓
Can’t say ⬜No ⬜
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Yes ⬜ No ✓Biochemical confirmation of self-reported abstinence at 28-week of pregnancy and 12-month postpartum for women and partners who reported not smoking in the previous 7 days. Intervention outcomes were based on self-reported abstinence.
Can’t say ⬜
iv-3
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
Women(%) Men(%)28wkG 19% 26% 2mPP 23% 28% 6mPP 21% 26% 12mPP 24% 40% [wkG=weeks of gestation; mPP=months postpartum]
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
Yes ✓
Can’t say ⬜No ⬜ Does not apply ⬜
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes ⬜ No ⬜
Can’t say ⬜ Does not apply ✓
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code as follows:
High quality (++)⬜
Acceptable (+)✓
Unacceptable – reject 0 ⬜
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
For the smoking men in PA groups received smoking cessation intervention directly and resulted in significant higher short-term abstinence at late pregnancy (at time point which the follow-up rate was the highest = 74%), due to no intervention for smoking partners in WO and UC, it is certain that the overall effect is due to the study intervention.
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
3 groups were compared (UC, WO and PA) at 4 different time points. It was found that no significant change in women’s smoking behaviour in all groups at all time points; significant abstinence rate of men in PA than in UC at 28-week gestation only. The authors stated that telephone counselors reported that men had difficulty thinking relationally and not able to assist the women in smoking cessation. This may in turn affect the cessation condition of men, Also, the intervention dose may not be sufficient with partners’ participation in counseling calls decreased throughout the trial. It did not state how much the men reading the self-help guide, using NRT patches and receiving counselling. Insignificance of the outcomes in other time-point for men may be caused by the low rate of use/ exposure to the interventions. However, it gave light to the aspect in adjusting the intervention with regards to couples’ interaction and support during the intervention process.
iv-3
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages) Oien, T., Storro, O., Jenssen, J.A. & Johnsen, R. (2008). The impact of a minimal smoking cessation intervention for pregnant women and their partners on perinatal smoking behaviour in primary health care: A real-life controlled study. BMC Public Health, 8, 325.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider: 1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the
study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question ⬜ 2. Other reason ⬜ (please specify):
! S I G N
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question. Yes ✓
Can’t say ⬜No ⬜
1.2 The assignment of subjects to treatment groups is randomised. Yes ⬜ No ✓It was a cohort control study.
Can’t say ⬜
1.3 An adequate concealment method is used. Yes ⬜ No ⬜
Can’t say ✓
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.
Yes ⬜ No ✓ This is a cohort interventional study.
Can’t say ⬜
1.5 The treatment and control groups are similar at the start of the trial. Yes ⬜ No ✓More primiparous women, fewer single mothers,more educated women and more drop-outs in the intervention cohort. Can’t say □
1.6 The only difference between groups is the treatment under investigation.
Yes ⬜ No ✓ Time lapse of 1 year between groups.
Can’t say ⬜
iv-3
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Yes ⬜ No ✓It relied on self-reported smoking behaviour since biomarkers test in this large epidemiological study was infeasible.
Can’t say ⬜
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
45.9% (intervention cohort group) 42.7% (control cohort group)
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
Yes ✓
Can’t say ⬜No ⬜ Does not apply ⬜
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes ⬜
Can’t say ✓No ⬜ Does not apply ⬜
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code as follows:
High quality (++)⬜
Acceptable (+)✓
Unacceptable – reject 0 ⬜
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Due to epidemiological reason, and wish to maintain the conformity between cohorts regarding population size, social characteristics etc., a prospective controlled cohort design was used and the 1-year time gap may have affect the outcome due to secular trend. The exposure of smoking cessation related elements within this year by the participants was unknown and so as the impact towards the outcome. Also, high drop-out rates in both groups may have weaken the effects but the authors stated that even a drop-out rate unto 60% there would still have no important bias. Moreover, the high quit rate in both cohorts should be due to spontaneous quitting before inclusion. This further affects the reliability of the outcomes. It is not certain that the overall effect is due to the study intervention.
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Uncertain.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
Partners smoking prevalence was significantly lower in the intervention cohort at inclusion and 6-week postpartum and lowered indoor smoking of couples in intervention cohort. However, due to the self-report smoking behaviour, 1-year time lapse, unknown exposure of counseling by smoking partners during the interventions, low participation rate and high drop-out rates, the positive outcomes achieved were not conclusively due to the intervention and not generalised enough to the study city. It tried to compare the quit rate of Trondheim (study city) and Bergen (no such intervention) that shown higher in the intervention city but only confined to women’s quit rate, no data of smoking partners were shown. The persuasiveness of the outcomes was not high. However, for such a large epidemiological study, it may not be feasible to have RCT design, biochemically validating the smoking status, eliminating the contamination between co-exist intervention and control group. More detailed in eliminating the possible bias should be stated to increase the credibility of the results.
iv-3
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages) Pollak, K.I., Lyna, P., Bilheimer, A.K., Gordon. K.C. et al. (2015). Efficacy of a Couple-Based Randomized Controlled Trial to Help Latino Fathers Quit Smoking during Pregnancy and Postpartum: The Parejas Trial. Cancer Epidemiology, Biomarkers & Prevention, 24(2), 379-385.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider: 1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the
study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question ⬜ 2. Other reason ⬜ (please specify):
! S I G N
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question. Yes ✓
Can’t say ⬜No ⬜
1.2 The assignment of subjects to treatment groups is randomised. Yes ✓
Can’t say ⬜No ⬜
1.3 An adequate concealment method is used. Yes ⬜ No ⬜
Can’t say ✓ It did not mention about concealment method.
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.
Yes ⬜ No ⬜
Can’t say ✓It did not mention about blinding method.
1.5 The treatment and control groups are similar at the start of the trial. Yes ⬜
Can’t say ✓No ⬜
1.6 The only difference between groups is the treatment under investigation.
Yes ✓
Can’t say ⬜No ⬜
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Yes ⬜ No ✓Study biochemically validated men’s reports of 7-day point –prevalence abstinence but not in 30-day point-prevalence.
Can’t say ⬜
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1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
21% (intervention group) 17 % (control group)
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
Yes ✓
Can’t say ⬜No ⬜ Does not apply ⬜
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes ⬜ No ⬜
Can’t say ✓It did not specify result for different centres.
Does not apply⬜
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code as follows:
High quality (++)⬜
Acceptable (+)✓
Unacceptable – reject 0 ⬜
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
This study compared the effect of less intensive intervention vs more intensive intervention. Both groups had high cessation rates for primary and secondary outcome. Also, high quit rates were found in non-daily smokers but no statistical differences in 2 groups. Lower quit rates with no statistical difference in daily smokers but favouring the more intensive group. This may be due to the insufficient of statistical power in detecting small sample size difference (daily smokers = 134). The authors stated that the cessation effect was higher than that in a previous trial.
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
It may be able to be directly applied to the target patient group but the culture difference may have effects on the applicability, e.g. culturally adapted written materials.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
Authors found that less intensive intervention seemed to be as powerful as a more intensive one, especially among nondayily smokers. However, daily smokers may need a more intensive intervention instead. Also, quit rates among the participants were higher in postpartum period. It is useful that they also provided data and differences between nondayily and daily smokers, which helps further investigation in specialising different level of interventions for different type of smokers. However, it stated that high cessation rates were obtained in both intervention groups in primary and secondary outcomes without clearly stating which source of baseline quit rate they were comparing with. Moreover, it would be even better if they can biochemically validate the 30-day point prevalence to make consistency in the reliability of abstinence for both outcomes. Also, more men in intervention groups used NRT, with the level of use of other intervention components were unknown, it may pose uncertainty of the insignificant different between less intensive and more intensive intervention.
iv-3
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages) Stanton, W.R., Lowe, J.B., Moffatt, J. & Del Mar, C.B. (2004). Randomised control trial of a smoking cessation intervention directed at men whose partners are pregnant. Preventive medicine, 38, 6-9.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider: 1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the
study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question ⬜ 2. Other reason ⬜ (please specify):
! S I G N
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question. Yes ✓
Can’t say ⬜No ⬜
1.2 The assignment of subjects to treatment groups is randomised. Yes ✓
Can’t say ⬜No ⬜
1.3 An adequate concealment method is used. Yes ✓ No ⬜ Subjects were randomized by staff not involved in recruitment or interviews
Can’t say ⬜
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.
Yes ⬜ No ⬜
Can’t say ✓It only mentioned that the participants were blinded.
1.5 The treatment and control groups are similar at the start of the trial. Yes ⬜ No ✓The intervention group was more likely than the control group to have their first cigarette <30min of waking, have lower the amount smoked since the confirmation of pregnancy, perceive that being able to abstain for a year. However, after adjusting the baseline difference, there was no impact on the outcomes.
Can’t say ⬜
1.6 The only difference between groups is the treatment under investigation.
Yes ✓
Can’t say ⬜No ⬜
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1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Yes ✓ No ⬜ Outcome was measured by self-report with validation of Carbon Monoxide test of certain portion of participants.
Can’t say ⬜
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
In a combination of both groups, 56 participants dropped out before the completion of study (10%)
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
Yes ✓
Can’t say ⬜No ⬜ Does not apply ⬜
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
Yes ⬜ No ⬜
Can’t say ✓ Does not apply ⬜
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code as follows:
High quality (++)✓
Acceptable (+)⬜
Unacceptable – reject 0 ⬜
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Since the interventions were directed at men, even the baseline characteristics were different in some aspects, after adjusting it statistically the outcome was not affected. Also, it validated the self-reported smoking status with biomarkers in some of the agreed subjects that shown reliable results, the positive outcome achieved was more persuasive.
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
It may be applicable. Samples included blue collar male with most of them having junior secondary education level. It may affect the outcome if we apply this to Hong Kong in which the characteristics of the husbands of prenatal users have to be investigated.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
Quit rate was found to be higher in intervention group with significant result ( 16.5% vs 9.3%,p=0.01). Also, predictors of quitting were also investigated: skilled workers, higher no. of quit attempts before and having first cigarette in the morning later were found to be more likely to quit. It would be better if all of the subjects’ smoking status were validated with CO test instead of part of them to achieve higher consistency and reliability of the results. There were differences between groups at their baseline characteristics. Authors adjusted them and found no impact to the outcome.
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Appendix 4 - Expenditures
Unit price Quanity Period Total costs (HKD)
Research assistant (RA)
$115/working hour
2 assistants • Pre-launching: 44 hours per week, total 2 weeks
• Post-trial:8 hours per day, total 2 days
• Post-innovation:44 hours per week, total 2 weeks
(For each RA)
$115 X [(44 X 2) X 2 + 8 X 2)] hours X 2 RA= $44160
Training costs $250/hour/nurse
2 nurses, each nurse handle half of the training hours
• 8 hours/day • 10 training days
$250 X 80 hours = $20000
Telephone fee $100/month 2 line 27 months $100 X27 = $2700
Total: $66860
iv-5Appendix 5 - Grades of Recommendation (Scottish Intercollegiate Guidelines Network, 2012)
A At least one meta-analysis, systematic review or RCT rated as 1++ and directly
applicable to the target population; or
A systematic review of RCTs or a body of evidence consisting principally of studies
rated as 1+, directly applicable to the target population and demonstrating overall
consistency of results
B A body of evidence including studies rated as 2++, directly applicable to the target
population and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+, directly applicable to the target
population and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 2++
D Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2+
iv-6
Appendix 6 - Evidence-based Practice (EBP) Guideline
After the evaluation of the feasibility, transferability and cost-effectiveness of the innovation
based on the reviewed studies, an EBP guidelines were developed with consideration of the level of
evidence and grades of recommendation.
Title of guidelines
Evidence-based practice guidelines of smoking cessation programme for smokers who are
partners of antenatal and postnatal women follow up in Obstetrics & Gynaecology (O&G)
department.
Aims and objectives of the guidelines
1. Develop clear clinical guidelines for healthcare professionals (HCPs) to
execute the smoking cessation intervention for target audience
2. Strengthen HCPs’ confidence and knowledge towards the principle and execution of
such programme
3. Provide standard of the cessation intervention
4. Optimize the effectiveness of the programme to assist targets to quit smoking
Target users of EBP guidelines
This guideline was developed for HCPs i.e. doctors and nurses working in Day Ward (D7),
Postnatal (PN) Ward of target hospital.
Target groups of the programme
Current male smokers (at least 1 cirgarette per day or have smoked in the past 30 days),
aged 18 or above, partners of pregnant women under antenatal (AN) care of target hospital and not
iv-6
currently participating in any other smoking cessation service, would be the target groups of this
programme.
Intervention strategies involved
Face-to-face counselling, telephone counselling, cessation self-help kit (written materials
and video) would be the intervention strategies involved, with the possible assistance by targets’
pregnant partners. Targets would also be referred to cessation clinic for getting Nicotine
Replacement Treatment (NRT) medication if indicated.
Recommendations
Recommendation 1: Cessation advice and education delivered by HCPs to current smokers can
be effective even it is a brief or a less intensive one. (Grade B)
Evidence: Results shown in Loke & Lam (2005) [1-] showed that brief and simple
interventions delivered by obstetrics professionals were effective in helping the husbands of
pregnant women at least in short-term basic. In Pollak et al. (2014) [1+], results did not differ
between more-intensive and less-intensive intervention group in helping expectant fathers to quit
smoking (daily smokers tended to need a more intensive one but the differences of the results were
small).
Recommendation 2: Antenatal period are “teachable moment” for expectant fathers who are
current smokers. (Grade B)
Evidence: Stanton et al. (2004) [1+] showed that smoking cessation intervention delivered
during male smokers’ partners’ pregnancy were effective (higher quit rate, more quit attempts,
having first cigarette in the morning later). McBride et al. (2004) [1-] showed that quit rates of
partners of pregnant women were significant higher in groups that provided cessation interventions
iv-6
to partners than those in usual care group at 28-week pregnancy. Loke & Lam (2004) [1-] showed
interventions during antenatal period resulted in higher 7-day abstinence significantly. Long-term
abstinence rate was also higher in intervention group. though it was insignificant. It may be only
due to sufficient statistical power in detecting small difference. Oien et al. (2008) [2-] showed that
prenatal interventions posed effect in lowering paternal smoking prevalence and parental indoor
smoking in intervention cohort. Although de Vries et al. (2006) [1-] showed no significant
differences in changing paternal smoking habit (intervention group: 70% vs control group: 74%), it
may be only because not all the pregnant women gave the designed booklet to their partners (76.2%
gave the partner the booklet) and not all the partners who received such booklet had read it (48.4%
of partners had read the booklet).
Recommendation 3: Postnatal period are “teachable moment” for expectant fathers who are
current smokers. (Grade B)
Evidence: Pollak et al. (2014) [1+] showed high cessation rate of partners in postpartum
period and authors suggested it may be because the actual presence of the babies.
Recommendation 4: Spousal involvement in cessation process may motivate their partners to
change their smoking habits. (Grade B)
Evidence: McBride et al. (2004) [1-] had pregnant women and their smoking partners
involved in the interventions process and encouraged couples’ communication resulted higher quite
rate than men in usual care group. Pregnant women participating in the study of Loke & Lam
(2005) [1+] gave advices to encourage their partners to quit smoking resulted in higher 7-day
abstinence than those in control group. Pollak et al., (2014) [1+], face-to-face couple-based
counselling was one of the interventions and resulted high cessation rate. In Oien et al. (2008) [2-],
iv-6
pregnant women were suggested to bring their smoking husbands along for cessation counselling
and resulted in low paternal smoking prevalence and parental indoor smoking in intervention
cohort.
Recommendation 5: Face-to-face, telephone counselling, self-help kit (written materials and
video) are useful interventions in smoking cessation. (Grade A)
Evidence: Face-to-face counselling involved smoking male partners was used in Pollak et al.
(2014) [1+], McBride et al. (2004) [1-] and Oien et al. (2008) [2-], all three studies showed positive
results in changing the expectant fathers’ smoking behaviour. Telephone counselling for smoking
male partners was used as one of the strategies in Pollak et al. (2004) [1+] and Stanton et al. (2004)
[1+], higher quit rate in intervention group were also achieved in both studies. Written materials as
self-help guidance were utilised in Stanton et al. (2004) [1+], McBride et al. (2005) [1-], Pollak et
al. (2014) [1+] and de Vries et al. (2006) [1-]. Positive results were yielded in the first three studies
but not in de Vries et al. (2006). As mentioned before, it may be due to the low distribution
prevalence and compliance of the written materials reaching the male smoking partners. Video was
only used in Stanton et al. (2004) but it contributed as one of the interventions in bringing positive
result for the study.
Recommendation 6: 5A’s, 5R’s, Motivational Interviewing (MI) should be used accordingly with
regards to targets’ stage of change. (Grade A)
Evidence: McBride et al. (2005) [1-] and Pollak et al. (2014) [1+] involved MI as the
counselling component. 5A’s (Ask, Advise, Assess, Assist, Arrange) and 5R’s (Relevance, Risks,
Rewards, Roadblocks, Repetition) are promoted by World Health Organization [WHO] (WHO,
2014) to be used in helping clients to quit and also in countries like USA (Fiore, Bailet, Cohen et
al., 2008) [1++]. Success rate of maintaining abstinence when smokers quit on their own is only
iv-6
about 5% rises up to 15%-25% if using the interventions suggested in the USPHS guideline (Fiore,
Hatsukami & Baker, 2002).
Recommendation 7: Nicotine Replacement Treatment (NRT) should be involved if indicated.
(Grade B)
Evidence: Stanton et al. (2004) [1+], McBride et al. (2005) [1-] and Pollak et al. (2014) [1+]
provided Nicotine patches to participants as one of the cessation interventions. All three studies
were able to achieve positive result in participants’ abstinence.
Recommendation 8: 7-day abstinence and 30-day abstinence should be assessed at baseline and
12-month post-innovation. (Grade B)
Evidence: Both Loke & Lam (2004) [1+] and Pollak et al. (2014) [1+] assessed 7-day
abstinence and 30-day abstinence at baseline and post-intervention. McBride et al. (2004) [1-]
assessed 7-day abstinence at baseline and post-intervention.
Appendix 7 - Overall timeline iv-7
Time Actions
1st month
2nd Month
3rd month
4th month
5th month
End of 4th month - 32nd month
33rd - 36th
month
week1
week2
week3
week 4
week5
week6
week7
week 8
week9
week10
week11
week12
week13
week14
week15
week 16
week17
week 18-32nd month (26 months
& 2 weeks)
33rd - 36th month
Communication plan
Communicate with Administrative stakeholdersCommunicate with middle-level staff
Formation of Working Group
Communicate with Frontline staff
Review of EBP guideline and gaining final approvalCommunicate with public
Pre-pilot test prepatation
Analysing characteristics of recruitable targetsDesigns of records and forms
Training
Pilot test plan Pilot test
Evaluation of pilot test and revise EBP guideline
Formal launch of the innovationEvaluation
iv-8
Appendix 8 - Timetable of communication plan
Week
Actions 1 2 3 4 5 6-15 & 17
Communicate with Administrative stakeholders
Communicate with middle-level staff
Formation of Working Group
Communicate with Frontline staff
Review of EBP guideline and gaining final approval
Communicate with public
iv-9
Appendix 9 - Questionnaire for nurses and doctors (after presentation in meeting)
Any other comments:
Questionnaire Please put a “√” into the box to indicate your answer, on a level from 1 to 5 OR No = 1 & Yes = 5. Thank you for your participation!
Strongly disagree
Very disagree Neutral Agree Strongly
agree
1 I understand the objective of the innovation.
2 I think that the smoking prevalence in Hong Kong is serious.
3 I think that smoking partners affect the health of the pregnant women and the fetus?
4 I tried to provide smoking cessation to smokers.
5 I am confident in providing face-to-face counselling.
6 I am confident in providing telephone counselling.
7 I think that the innovation can help smoking expectant fathers to quit smoking.
8 I am interested in participate in this innovation in the future.
iv-10Appendix 10 - Timetable of pilot test
Week
Actions 6 7 8 9 10 11 12 13 14 15 16 17
Analysing characteristics of recruitable targets
Designs of records, forms snd self-help kits
Training
Pilot test
Evaluation of pilot test
iv-11Appendix 11 - Self-help kit
For smoking husbands:
*Video is suggested to be watched together with wives
For smoking husbands’ partners:
Components Content
Written materials (1) Introduction of the self-help kit; (2) Reasons to quit; (3) Tips on how to quit; (4) How to quit with the help of partners; (5) How to deal with conflicts with partners in the process of
cessation (6) Contacts methods for enquiry
Video* Case sharing: (1) a father who used to be smoking before the child was born and
how he succeeded in quitting; (2) a couple with the husband was smoker, talking about the ups and
downs in the cessation process and how they supported each other to overcome difficulties
Components Content
Written materials (1) Education about the cons of passive smoking towards husbands, themselves and the fetus/newborn infants;
(2) Strategies to help their partners to quit; (3) Actions they can take when exposing to passive smoking; (4) How to deal with conflicts with partners in the process of
cessation (5) Contacts methods for enquiry
iv-12Appendix 12 - Questionnaire for staff: satisfaction and compliance (post-pilot test & post-formal
launch)
Any special barriers encountered:
Any other comments:
Questionnaire Please put a “√” into the box to indicate your answer. Thank you for your participation!
1 Job position Doctor ☐ Nurse ☐
Strongly disagree
Very disagree Neutral Agree Strongly
agree
2 The overall performance of the programme is successful.
3 I am satisfied with my performance in this programme.
4 The pre-launch training is useful.
5 I follow all the recommendations in the EBP guideline.
6 I have enough time to provide cessation counselling for the clients.
7 I am confident in providing face-to-face counselling.
8 I am confident in providing telephone counselling.
9 The workload for this programme is appropriate.
10 The programme did not interfere with daily routine.
11 The innovation can help smoking expectant fathers to quit smoking.
12 I am interested in participate in this innovation in the future.
13 I would recommend others to join this innovation.
iv-13Appendix 13 - Questionnaire for clients & their partners (post-pilot test and post-formal launch)
Any special barriers encountered:
Any other comments:
Questionnaire Please put a “√” into ☐ or the box to indicate your answer, on a level from 1 to 5 OR No = 1 & Yes = 5 according to different questions. Thank you for your participation!
1 GenderMale ☐ Female ☐ (Smoker ☐; Non-smoker ☐; Ex-smoker ☐)
2 Age Under 20 ☐ 20-30 ☐ 31-40 ☐ 41-50 ☐ Above 50 ☐
3 How did you know about this programme? (can choose more than one)
From posters in hospital ☐ From video in hospital ☐ From relatives/ friends ☐ Others (please indicate) ☐___________________
Strongly disagree
Very disagree Neutral Agree Strongly
agree
1 This programme is good.
2 The Self-help kit was useful.
3 I read the written materials in the Self-help kit.
4 I watched the video in the Self-help kit.
5 I followed the cessation tips I learnt.
5 The face-to-face counselling was useful.
6 The duration of face-to-face counselling was appropriate.
7 [For fathers only] The telephone counselling was useful.
8 [For fathers only] The duration of telephone counselling was appropriate.
9 There was enough support from healthcare professionals.
10 The programme did not interfere with daily life.
11 The programme can help smoking expectant fathers to quit smoking.
12 I am interested in participating in this programme in the future again if needed.
13 I would recommend others to join this programme.
iv-14
Appendix 14 - Timeline for smoking cessation counselling and data collection
*Normal gestational week for delivery
Gestational week Venue Data collection for evaluation Type of counselling
12 D7 Age, education level, job, smoking status, no. of cigarette/day, no. of quit attempt, household information
Face-to-face counselling
16 / / Telephone counselling
24 / / Telephone counselling
38* PN ward Smoking status, 7-day point prevalence abstinence , 30-day point prevalence abstinence , no. of quit attempt, no. of cigarette taken per day
Face-to-face counselling
4 weeks PN / / Telephone counselling
8weeks PN
O&G SOPD Smoking status, 7-day point prevalence abstinence , 30-day point prevalence abstinence , no. of quit attempt, no. of cigarette taken per day, satisfaction towards the programme
Face-to-face counselling
iv-15Appendix 15 - Question about “skills, knowledge & confidence” of staff (pre-training, post-training
and at the end of the programme)
Questionnaire Please put a “√” into ☐ or the box to indicate your answer, on a level from 1 to 5 OR No = 1 & Yes = 5. Thank you for your participation!
1 Job position Doctor ☐ Nurse ☐
2 What do 5As stand for in the sense of smoking cessation?
3 What do 5Rs stand for in the sense of smoking cessation?
4 What does MI stand for in the sense of smoking cessation?
5 Name at least one behavioural technique to help smokers to stop smoking.
6 Name at least one organization that provides smoking cessations services.
Strongly disagree
Very disagree Neutral Agree Strongly
agree
7 Smoking only affects adults.
8 Smoking does not affect fetus.
9 We do not need to ask the smoking status every time we meet the clients.
10 We could encourage smokers to cut down the no. of cigarette they smoke instead of quit at once.
11 Brief cessation does not help smokers at all, only an intensive one can.
12 Are you confident in providing face-to-face counselling?
13 Are you confident in providing telephone counselling?
14Do you feel worried to implement the programme? (Please state the reason(s): ______________________________________________)
v
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