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Abstract of dissertation entitled
“An evidence-based guideline for applying water-based lubricant to
reduce pain for women undergoing cervical screening in the
Maternal & Child Health Centre”
Submitted by
MAK TSZ YAN
for the degree of Master of Nursing
at The University of Hong Kong
in August 2016
Cervical cancer is one of the most common cancers among female. Cervical
screening (CS) could reduce the incidence and mortality of cervical cancer by
identifying asymptomatic women who are at risks of precancerous cell changes such
that prompt treatment could be provided at a timely manner. Fear of pain and
discomfort have been suggested by many literatures as a common barrier causing
hesitation in undergoing CS among women. On the other hand, carbomers-free
water-based gel lubrication such as KY Jelly is affirmed to effectively reduce pain
ii
associated with the use of vaginal speculum without affecting the cytology
interpretation of CS. This dissertation is intended to investigate the possibility of using
water-based gel as vaginal speculum lubrication during CS in eliminating barrier for
undergoing CS in the Maternal and Child Health Centres (MCHCs) in Hong Kong.
Five literatures were critically appraised which revealed that use of water-based gel
lubrication is cost-effective, feasible and transferable to MCHCs. An evidence-based
practice (EBP) guideline with 4 recommendations is then established to provide
guidance and a communication and implementation plan is also set up to facilitate
future implementation and effective communication among medical staff in the
MCHCs. A pilot study will also be launched in one of the MCHCs to test its feasibility.
The whole process is expected to take 9 months from preparation, gaining approval
from the administrator, staff training, formal implementation, data analysis and
program evaluation. It is expected that the use of water-based gel lubrication could
reduce the pain associated with vaginal speculum examination in CS by 10% and
should be generalized to other MCHCs in the long run.
iii
“An evidence-based guideline for
applying water-based lubricant to reduce pain for women
undergoing cervical screening in the
Maternal & Child Health Centre”
By
MAK TSZ YAN
BSc (Hons) in Nursing The Hong Kong Polytechnic University
A dissertation submitted in partial fulfillment of the requirements for
the Degree of Master of Nursing
at The University of Hong Kong.
August 2016
iv
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…………………………………………………………………………………
MAK TSZ YAN
v
Acknowledgements
I would like to express my sincere gratitude and heartfelt thanks to my supervisor
Dr. Elizabeth Hui, for her patience and support throughout the programme. This
dissertation would not be possible without her guidance and valuable advice.
I would also like to take this opportunity to express my profound gratitude to the
Department of Health for sponsoring me in studying the Master of Nursing Programme
at the University of Hong Kong. I have met so many great teachers who inspired me a
lot and arouse my interest in nursing again.
Finally, special thanks to my family, partner, colleague and classmates for
encouraging me all the time and providing me with unfailing support. They would
never let me down when I am in need. Thank you.
vi
Table of Contents
Abstract ............................................................................................................................... i
Declaration ........................................................................................................................ iv
Acknowledgements ............................................................................................................ v
Table of Contents .............................................................................................................. vi
List of Appendices .......................................................................................................... viii
Chapter 1 - Introduction ................................................................................................. 1
1.1 Background .................................................................................................................. 1
1.2 Affirming needs ........................................................................................................... 4
1.3 Objectives and Significance....................................................................................... 10
1.3.1 Objectives ............................................................................................................... 10
1.3.2 Significance of Reducing Discomfort Induced by Speculum Examination ........... 10
Chapter 2 - Critical Appraisal ...................................................................................... 12
2.1 Search and Appraisal Strategies ................................................................................ 12
2.1.1 The Searching Strategy ........................................................................................... 12
2.1.2 Inclusion & Exclusion Criteria ............................................................................... 13
2.1.3 The Appraisal Strategy ........................................................................................... 13
2.2 Results........................................................................................................................ 15
2.2.1 The Search Results ................................................................................................. 15
2.2.2 Data Extraction ....................................................................................................... 15
2.2.3 Quality Assessment & Appraisal Results ............................................................... 19
2.3 Summary and Synthesis ............................................................................................. 23
2.3.1 Summary of Study Results ..................................................................................... 23
2.3.2 Data Synthesis ........................................................................................................ 24
2.4 Conclusion ................................................................................................................. 27
vii
Chapter 3 - Implementation Potential and Clinical Guideline ..................................... 28
3.1 Transferability of the Findings .................................................................................. 28
3.2 Feasibility .................................................................................................................. 33
3.3 Cost-Benefit Ratio ..................................................................................................... 37
3.4 Developing an EBP Guideline ................................................................................... 41
Chapter 4: Implementation Plan .................................................................................. 43
4.1 Communication Plan ................................................................................................. 43
4.1.1 Initiating the change ............................................................................................... 45
4.1.2 Sustaining the changes ........................................................................................... 46
4.2 Pilot Study Plan ......................................................................................................... 46
4.2.1 Material Required ................................................................................................... 47
4.2.2 Training for Medical Staff ...................................................................................... 49
4.2.3 Logistics ................................................................................................................. 50
4.3 Evaluation Plan .......................................................................................................... 54
4.3.1 Sample Size ............................................................................................................ 54
4.4 Basis for Implementation ........................................................................................... 55
Conclusion ................................................................................................................... 56
Appendices ................................................................................................................... 57
Reference ..................................................................................................................... 86
viii
List of Appendices
Appendix A - Table of Evidence................................................................................ 57
Appendix B – SIGN Checklist…………………………………............................... 60
Appendix C - SIGN Grading System….………………………………………….....70
Appendix D- PRISMA………....……….....…………….…....…………...………...71
Appendix E- Quality Assessment Using SIGN Methodology Checklist for Controlled
Trials…………….…….....................……………………………….. 72
Appendix F - Gantt Chart……………………………............................................... 74
Appendix G - Service timetable at designated MCHC……………………..…...…. 75
Appendix H – Budget Plane………………………………………………………...76
Appendix I – Evidence-based Practice (EBP) Guideline…………………………....77
Appendix J - Grades of Recommendations…………………………………….…...81
Appendix K – Photo Demonstration……………………………………….………..82
Appendix L - Questionnaire for all Medical Staff.………………………………….83
Appendix M - Satisfaction and Self-reflected Competence Questionnaire for Smear
Taker………………………………………………………...……....84
Appendix N - Satisfaction Questionnaire for Participant………..………………….85
1
Chapter 1 - Introduction
1.1 Background
Cervical Screening
Cervical Screening (CS) are tests performed to identify women whose cervix are
undergoing abnormal cell changes as an early diagnostic tool targeting cervical
cancer (Cervical Screening Programme [CSP], 2015). Abnormal cervical cells could
further develop into pre-cancerous cells, finally leading to cervical cancer. The
whole process may take 5 to 10 years, during which the woman suffering may not
experience any symptoms in the early stages of cell changes (World Health
Organization [WHO], 2015). The cervical screening programme aims to detect
pre-cancerous and cancerous women who may not be experiencing any symptoms
and to treat these abnormalities as early as possible so as to prevent the development
of cervical cancer (Centre for Health Protection [CHP], 2015a).
There are three main types of screening test including conventional cytology,
liquid-based cytology and visual inspection using acetic acid with human
papillomavirus (HPV) testing for high-risk HPV types (WHO, 2015). Among these
tests, liquid-based cytology is more frequently performed nowadays in Hong Kong
(HK) compared to conventional cytology due to its increased effectiveness and
higher accuracy. Wooden spatula are used to collect samples of cervical cells under
2
conventional cytology at the same time requiring technique of proper fixation and
spreading of cells on a glass slide while a broom type device is used for liquid-based
cytology.
Cytological tests involving cervical smear are screening tests rather than
diagnostic in nature (Cervical Screening Programme, 2015). They are to be done at
regular intervals among “healthy” women. If abnormal cells are detected on the
cervical smear, further investigation would be needed to classify the severity of cell
change and treatment would then be prescribed accordingly to help prevent cancer
development. Thus, CS helps to identify those who are prone to cervical cancer
among the asymptomatic population.
The screening procedure involves inserting a double bladed speculum into the
vagina and obtaining a small amount of cells from the cervix with a wooden spatula
or cytobrush after dilation of the speculum and then preserving the cells in a small
pot of preservative. Before the insertion, the speculum may be wetted by dipping into
normal saline for a few seconds in order to provide lubrication. The specimen
collected will then be screened for any abnormal cell changes in the laboratory. The
whole process from medical history taking to culture collection only requires
approximately 10 to 15 minutes and can be performed in an outpatient clinic setting
without admission and without the use of anesthesia.
3
Pain as a barrier
Although CS is simple and quick to perform, hesitation is common among women
due to fear of pain and discomfort during the procedure. Pain is defined as “an
unpleasant sensory and emotional experience associated with actual or potential tissue
damage, or described in terms of such damage” by the International Association for the
Study of Pain (IASP) (2012). It is one of the barriers preventing women from
participating in CS (Al-naggar & Isa, 2010; Harmanli & Jones, 2010; Holroyd, Twinn
& Shia, 2001). A study by Holroyd, Twinn, & Shia (2001) revealed that 68.2% of the
participants, all of whom are Chinese women, perceived undergoing CS as an
unpleasant experience and often associated with pain and distress. Furthermore, the
pain experienced may be exacerbated among peri-menopausal and post-menopausal
woman due to the thinner lining or atrophic vaginal mucosa and vaginal dryness
(Gungorduk, Ozdemir, Gokcu, & Sanci, 2014; Hoyo et al., 2005). Since past
experiences of CS may affect women‟s compliance to future screening, a thorough
investigation on the choice of speculum lubrication during CS may help to reduce the
associated pain and promote compliance to CS in the long run.
4
Significance of CS
Cervical cancer is one of the common cancers among female globally. In 2012, it
is the ninth leading cause of female cancer deaths in HK (CSP, 2013a). As women
suffering from cervical cancer may either not experiencing any symptom at all or
simply just by pass the commonest symptom - irregular vaginal bleeding, it is important
to promote regular cervical cancer screening and adherence to the programme for early
identification, hence to reduce incidence and mortality.
1.2 Affirming needs
CS by liquid-based cytology can be performed easily and quickly under a simple
clinic setting. Nil admission and anesthesia are required. It could be performed under an
outpatient gynecology clinic where a gynecological examination bed with stirrups and
lighting equipment are made readily available.
CS in HK
In HK, Maternal & Child Health Centres (MCHC) under the Department of Health
(DH) have been one of the chief CS providers ever since the launch of CSP by the
government in 2003. As demonstrated by Twinn and Cheng (1999), CSP is a nurse-led
screening programme attempting to achieve a high level of satisfaction from clients in
5
with nurses taking up the responsibility in performing the screening procedure for
clients attending for routine checkups. Since 2005, there have been more than 108,000
cervical cytology tests recorded per year under CSP provided by DH (CHP, 2015b).
The proportion of women aged 25 to 64 who registered under CSP also increased from
3.6% in 2004 to 19% in 2014. However, the growth in utilization rate has become static
within the past few years with less than 1% increase per year since 2010. It is hope that
reduction of procedural pain during CS through a better choice of speculum lubrication
could help to boost up the utilization rate such that a more thorough coverage of CS
could be achieved among the vast female population in HK.
CS Practice in MCHC
The Screening Policy with screening criteria and classification of cytology result
employed in MCHC was set based on guideline issued by The Hong Kong College of
Obstetricians and Gynaecologists (HKCOG) (2002). This is a set of guidelines serving
among MCHCs, last updated in 2010, instructed all the medical staff to refrain from
applying water-based gel lubricant such as KY-Jelly onto the speculum in order to
avoid contamination of specimen and unsatisfactory results. Instead, current practice
advocates for the use of water-lubricant such as normal saline for speculum lubrication.
However, no evidence-based review is currently available to sustain the superiority of
6
water-lubricant over water-based gel lubricant in minimizing the risk of unsatisfactory
results. On the contrary, studies including those conducted by Hill and Lamvu (2012),
Lin, Taylor, Alperstein, Hoda and Holcomb (2014) and Rosa et al. (2012) stated that
carbomers-free water-based gel lubrication such as KY-Jelly would not interfere the
quality of CS cytology.
An obvious knowledge gap is existing between current practice and research
findings, and the need to narrow this gap is deemed necessary particularly after MCHC
replaced the stainless steel speculum with plastic disposable ones in 2015. Ever since
the replacement of plastic speculum, there have been increasing number of
uncomfortable experiences reported from clients due to insertion difficulty of plastic
speculum despite lubrication using water-lubricant before the procedure. Although the
use of plastic disposable speculum could reduce the risks of infection, could streamline
the manpower and resources allocated for cleansing and disinfecting the instrument as
well as could avoid disruption of service due to break down of autoclave machine,
barriers like fear of pain and discomfort during the examination procedure may prevent
women for undergoing regular screening if the issue of insertion difficulty for plastic
speculum is not properly addressed (Al-naggar & Isa, 2010; Abreu, Horsfall,&
Learmonth, 2013; Holroyd et al., 2001).
7
Inconsistence in nursing practice due to affected nursing competency
Complaints of discomfort from clients may also affect nurses‟ competency in
performing the screening procedure. Since water-lubricant fails to provide adequate
lubrication effect for plastic speculum and lead to insertion difficulty with pain, nurses
are reluctant to replace the stainless steel speculum with plastic disposable ones. In
order to overcome this issue, some doctors and nurses have suggested to find an
alternative for plastic speculum lubrication, and the possibility of water-based gel
lubrication has thus been raised. Studies conducted by Simavli, Kaygusuz, Kmay and
Cukur (2014) and Uyger et al. (2012) have reported that the use of water-based gel
lubricant may significantly reduce the pain associated with insertion and dilation of
speculum as it may reduce the friction induced during speculum insertion.
Suggestions such as careful application of KY-Jelly without involving the tip of
speculum as well as the use of carbomers-free water-based lubricant have been made
in an attempt to strike a better balance between specimen quality and client comfort,
but no systematic review is carried out in the current setting to support these
innovations. As a result, practices among healthcare professionals maybe inconsistent
and fail to adhere to clinic guideline. This paper thus aims at narrowing down the gap
between current practice and research findings by developing an evidence-based
8
protocol for plastic speculum lubrication during CS such that improvement in current
CS practice could eventually be achieved.
Water Lubricant versus Water-based Lubricant
Lubricants used during medication examination in HK commonly come in two
forms: liquid form and gel-like substance. In the following discussion, liquid type
water-lubricant is referred to normal saline while gel-like water-based lubricant is
represented by KY-Jelly due to their popularity and accessibility in MCHC setting.
The Innovation: Use of KY-Jelly as lubrication during speculum examination
Due to the advancement in technology, an ongoing update for medical guidelines
and procedures is essential in providing high quality service for clients. Although many
studies had been carried out to investigate the effectiveness and feasibility of
water-based lubricant in speculum examination, no systematic review is published to
affirm its feasibility in MCHC setting. It is therefore necessary to synthesize a review
from current literatures so as to justify the use of KY-Jelly as plastic speculum
lubrication during CS in MCHC setting.
9
Research Questions
Research questions are set up to identify the phenomenon and to propose
innovation that is to be further studied. They help to summarize the ideas and to set
focus on the main concerns after affirming the needs and significance of the proposed
innovation. As a result, these research questions have been established:
For women attending MCHC for routine CS, how effective is the water-based gel
lubricant (KY-Jelly) in altering the level of pain or discomfort as compared to
water lubricant (normal saline)?
Is it feasible to use water-based gel as speculum lubrication for CS without
affecting the quality of cytology?
PICO
P (Patient): Woman above 18 years old undergoing CS
I (Intervention): Application of water-based gel lubricant (KY-Jelly)
C (Comparison): Current lubrication practice (i.e. use of normal saline)
O (Outcome): Level of pain or discomfort
10
1.3 Objectives and Significance
1.3.1 Objectives
To determine the effectiveness of water-based lubricants in reducing pain for
women undergoing CS
To examine the degree of interference in cytology adequacy when water-based gel
lubricants are applied during CS
To explore the feasibility of using water-based gel lubricants during CS in MCHC
setting
To generate an evidenced-based practice (CHP) guideline for CS
1.3.2 Significance of Reducing Discomfort Induced by Speculum Examination
The degree of pain perceived by women undergoing CS can be related to previous
unpleasant experience which would cause psychological distress in future gynecology
examination involving the use of speculum (Wong, Wong, Low, Khoo, & Shuib, 2008).
As suggested by Twinn and Cheng (1999), Abercrombie (2001) and Holroyd et al.
(2001), fear, anxiety and pain are the major factors contributing to the reluctance of
undergoing CS among the female population as they perceived CS as a painful
procedure with fear of acquiring internal injury and bleeding after the screening.
Non-compliance to routine CS may result in negative health consequences among
11
female, particularly for women with precancerous cell changes as close monitoring and
prompt treatment could not be delivered in a timely manner if they fail to adhere to the
follow-up schedule. Furthermore, perceived pain during CS may also discourage
women from initiating their first smear checking which hinders CS uptake rate despite
the programme is well-designed with easy accessibility and at low cost. In addition, CS
recipients tend to associate nurses‟ expertise in CS with the degree of fear and pain
experienced during the examination (Twinn, 1999). Thus innovation to minimize the
discomfort associated with speculum examination during CS is necessary to alleviate
the negative effect of procedural pain on nurses‟ competency and to promote adherence
to the screening schedule.
12
Chapter 2 - Critical Appraisal
2.1 Search and Appraisal Strategies
To proceed, inclusion and exclusion criteria for searching relevant studies and
critical appraisal were set up. Keywords for searching were developed. Electronic
databases for searching were selected.
2.1.1 The Searching Strategy
Two electronic databases including PubMed and Cochrane Library were selected
for searching relevant studies, Three sets of keywords were used for searching as
shown below:
“speculum examination” OR “cervical screening”,
“lubricant”
“pain”.
Manual search of reference lists of the eligible studies and relevant reviews were
also conducted so as to identify other related studies for critical appraisal.
13
2.1.2 Inclusion & Exclusion Criteria
Inclusion Criteria. To tally with the target group of CSP in MCHC, only studies
conducted on symptom-free female aged 18 or above were included for this critical
appraisal.
Exclusion Criteria. Women with the following characteristics were excluded:
History of total or subtotal hysterectomy,
Simultaneously undergoing other gynecological treatment that requires vaginal
pessary
Pregnancy
2.1.3 The Appraisal Strategy
After identifying eligible studies though database searching, critical appraisal was
performed according to the suggestions made by the Scottish Intercollegiate Guidelines
Network (SIGN) (SIGN, 2011).
As suggested by SIGN (2014), recommendations of guideline should be based on
a systematic review of the available scientific literature. These literatures should be
assessed for their quality to ensure that they were adequate to support the guideline
developed. In this review paper, each of the individual studies identified would first be
14
summarized in a Table of Evidence (TOE) in which the level of evidence and the key
characteristics of the studies will be listed out (Appendix A). As all the literature
identified in this review paper were randomized controlled trials (RCTs), each of them
was screened using the September 2015 version of SIGN Methodology Checklist for
Controlled Trials (SIGN, 2014) (Appendix B). The SIGN checklist consists of two
sections. The first section appraised on the internal validity of the evidence. The area
reviewed included focused question of the topic, randomization, allocation
concealment, blinding, comparability of groups, differences between groups, valid and
reliable outcome measures, drop-out rate, intention-to-treat analysis and comparability
of results across different sites. The second section referred to the overall assessment. It
consisted of the risk of bias, overall effect due to intervention alone, applicability of the
result to target group, a brief summary on the conclusion of each study and lastly the
level of evidence. The level of evidence for each individual studies would be graded
using the grading system suggested by SIGN (Appendix C) (SIGN, 2011).
15
2.2 Results
2.2.1 The Search Results
Searching of eligible studies was carried out with the last search done on 6th
September, 2015. Two electronic databases, namely PubMed and Cochrane Library
were selected. By using the three set of keywords previously mentioned, a total of 258
citations were generated. After eliminating 11 duplicated citations, the titles and study
design of 247 citations were screened to include those with RCT only. As a result, 165
citations were excluded. Among the 82 remaining records, only 71 of them with
full-text available and could be further assessed for eligibility. After screening through
the abstracts of these 71 citations, 66 of them were excluded either for failure to meet
the inclusion criteria or for violating the exclusion criteria. Manual searches through the
reference lists of eligible studies and relevant reviews were also performed with no
additional study identified. As a result, a total of 5 eligible studies were identified.
Details of the literature searching were presented in the PRISMA Flow Diagram in
Appendix D.
2.2.2 Data Extraction
In order to facilitate cross-study comparison, data regarding nature of study,
sample characteristics, intervention and control groups, outcome measures as well as
16
the effect size from the 5 eligible studies were extracted and summarized in TOE
(Appendix A).
Summary of Study Characteristics
Nature of study & Publication Year. All the five studies were using RCTs to
investigate the effect of water-based lubrication on CS and were written in English
(Gilson, Desai, Cardoza-favarato, Vroman & Thornton, 2006; Gungorduk et al. 2014;
Hill & Lamvu, 2012; Simavli et al., 2014; Uyger et al., 2012). The selected studies were
published between 2006 and 2014 with levels of evidence ranging from 1+ (Gilson et
al., 2006; Gungorduk et al., 2014; Simavli et al., 2014; Uyger et al., 2012) to 1++ (Hill
& Lamvu, 2012).
Sample Characteristics. All the studies included female participants only. They
were conducted in outpatient service setting with four of them under the gynecology
department of the hospital (Gungorduk et al., 2014; Hill & Lamvu, 2012; Simavli et al.,
2014 & Uygur et al., 2012) and one under a family clinic (Gilson et al., 2006).
Participants were all attending either for routine CS or gynecological checkup requiring
speculum examination.
Intervention & Control Group. There were only one intervention group (IG)
and one control group (CG) throughout the study in four of the literatures (Gungorduk
17
et al., 2014; Hill & Lamvu, 2012; Simavli et al., 2014 & Uyger et al., 2012). Subjects in
these studies were randomized into either intervention or control group. For the study
by Gilson et al. (2006), each of the participants acted as their own control with the first
smear performed. They were than allocated randomly to either intervention or second
control group with the second smear. Comparisons were made between the two smears
done on the same subject and between the IG & CG for the second smears performed.
Water-based lubrication was applied to the external side of the disposable plastic
speculum before insertion to the vagina in four of the IG of the studies (Gilson et al.,
2006; Gungorduk et al., 2014; Simavli et al., 2014; Uyger et al., 2012). One of the
studies applied water-based lubrication at the distal tip of the speculum in the IG (Hill
& Lamvu, 2012).
For the CGs, water was used as the lubrication in the studies of Gungorduk et al.
(2014) & Uyger et al. (2012), while the rest of the 3 studies used dry speculum without
applying any lubrication for their CGs.
Outcome Measures. All the studies used level of pain and cytology adequacy as
their outcome measures. Four of them measured the pain level at the time of speculum
insertion (Gungorduk et al., 2014; Hill & Lamvu, 2012; Simavli et al., 2014; Uyger et
al., 2012). Gungorduk et al. (2014) even included assessment of pain at the time of
18
speculum dilation and extraction. The study by Gilson et al. (2006) was the only one
measuring the pain associated after completion of papanicolaou smear taking.
For assessment tools, Visual Analog Scale (VAS) was used by Gungorduk et al.
(2014) and Hill & Lamvu (2012). Numeric Pain Scale was used by Simavli et al. (2014)
and Uyger et al. (2012), while Gilson et al. (2006) used the Wong-Baker Faces Pain
Rating Scale in their study. All the pain assessment tools involved consist of a set of
ratings from 0 to 10, with 0 representing “no pain” and 10 being “the worst possible
pain”. In all the 5 studies, pain level was self-reported by the participants.
Two of the studies have the same portion of smear being “unsatisfactory for
evaluation” in both CG and IG (Simavli et al., 2014; Uyger et al.,2012). Another two
studies reported none of the smears had unsatisfactory result for both CG and IG
(Gungorduk et al.,2014; Hill & Lamvu, 2012). The study of Gilson et al. (2006)
reported two unsatisfactory smears in the IG due to obscurity by blood and poor
fixation of cell onto the glass slide while no unsatisfactory smear was identified in the
CG.
Effect Size. The effect sizes of the outcomes were described as the difference
between IG and CG with statistical significance set at p<0.05 in all the five studies.
Gungorduk et al. (2014) and Uyger et al. (2012) presented the decrease in the mean of
pain value of all participants during insertion of speculum as -1.33 (p<0.001) and
19
-0.6(p<0.05) respectively. Simavli et al. (2014) also compared the change in pain level
during insertion phase but they expressed it in terms of median with -1 (p<0.001). On
the other hand, the overall effect size stated by Hill & Lamvu (2012) was -0.74
(p<0.011) in mean.The study of Gilson et al. (2006) was the only one reporting positive
change in the mean of pain level with 0.1 (p=0.69) among all the five studies.
2.2.3 Quality Assessment & Appraisal Results
The internal validity and overall quality of the 5 studies were assessed using the
SIGN Methodology Checklist for Controlled Trials (SIGN, 2014) (Appendix B).
Section 1: Internal Validity
Focused Question. All the five studies could demonstrate an appropriate and
clearly focused question evaluating the relationship between the lubrication used
during speculum examination and its associated pain. They could all be presented in
form of the PICO format. All of them concluded that the choice of lubrication would
not affect smear adequacy of CS.
Randomization. Computer-generated allocation method was used in all studies to
randomize subject allocation. Hill & Lamvu (2012), Simavli et al.. (2014) and Uyger et
al. (2012) allocated their subjects by the permuted block method. Blocks were chosen
20
randomly by using computer-generated random number during the creation of
allocation list. In the rest of the two studies, Gilson et al. (2006) used a random number
table while Gungorduk et al. (2014) used a chart generator for subject allocation, with
which both the random number table and chart generator were also randomly generated
by computer.
Allocation Concealment. Study conducted by Hill and Lamvu (2012) was the
only study mentioning details concerning allocation concealment. It stated that the
result of randomization were sealed in opaque envelopes and arranged in sequential
order unknown to the participants and investigator. The remaining four studies did not
mention any method of allocation concealment at all (Gilson et al., 2006; Gungorduk et
al., 2014; Simavli et al, 2014; Uyger et al., 2012).
Blinding. Four of the studies were able to achieve single-blinding by keeping
participants blinded to the treatment allocated (Gilson et al., 2006; Hill & Lamvu, 2012;
Simavli et al., 2014; Uyger et al., 2012). All the studies managed to blind the
cytotechnologists who were responsible to evaluate the specimen collected for CS but
none of them were able to blind the primary physician performing the smear collection.
The study by Gungorduk et al. (2014) was a non-blinded trial as both the participants
and primary physician were not blinded.
21
Comparable Groups. All participants in the IGs and CGs were similar in
characteristics before the implementation of intervention. No significant difference in
characteristics were identified in terms of age, parity and use of contraception.
Treatment is the only difference. Across the five studies, speculum examinations
were performed in a standardized way. Participants from IGs and CGs were all treated
with the same kind of speculum with the only difference being the kind of lubrication
used between the IGs and CGs.
Outcome Measures. Gilson et al. (2006) measured the primary outcome by the
Wong-Baker Faces Pain Rating Scale. Gungorduk et al. (2014) & Hill & Lamvu (2012)
mentioned the use of VAS, whereas Simavli et al. (2014) and Uyger et al. (2012) used
the Numeric Rating Scale. Both Hill and Lamvu (2012) and Uyger et al. (2012)
acknowledged the measuring tool they used as valid and reliable, while the rest of the 3
studies did not specify the validity of the assessment tools used.
Drop-Out Rate. None of the participants dropped out in 3 of the studies (Gilson et
al., 2006; Simavli et al., 2014; Uyger et al., 2012). There were 2% and 3% drop-outs for
the IG and CG respectively in the study of Gungorduk et al. (2014) while 1.67%
dropped out in the IG and no drop-out in CG were reported in the study conducted by
Hill and Lamvu (2012).
22
Intention-to-Treat Analysis (ITT). In the studies conducted by Gilson et al.
(2006), Simavli et al. (2014) and Uyger et al. (2012), ITT was used to achieve zero
drop-out rate. In the other two studies, modified ITT was used with justification for
excluding subjects clearly stated.
Comparable Results from All Sites. As all studies were carried out in one site only,
it is not applicable to comment on the comparability of results from different sites.
Section 2: Overall Assessment
Risks of Bias Minimized. Although all the studies have good randomization with
computer-generated allocation method, medium risks of bias were identified for four of
the studies due to failure of including allocation concealment details in their studies
(Gilson et al., 2006; Gungorduk et al., 2014; Simavli et al., 2014; Uyger et al., 2012).
They were graded as “low quality (-)” in minimizing the risks of bias. Hill & Lamvu
(2012) scored an “acceptable (+)” level in minimizing the risks of bias with good
randomization and clear allocation concealment method mentioned.
Overall Effect & Result Applicability. The overall effects of the studies were due
to the intervention alone with all results applicable to the target group of this review
paper.
23
Level of Evidence. Levels of evidence were assigned based on the SIGN Grading
System as shown in Appendix C (SIGN, 2011). The study of Hill and Lamvu (2012)
was rated 1++, while the remaining four studies were rated 1+ (Gilson et al., 2006;
Gungorduk et al., 2014; Simavli et al., 2014; Uyfer et al., 2012).
2.3 Summary and Synthesis
2.3.1 Summary of Study Results
All the studies included in this review paper evaluated the effectiveness of
speculum lubrication in reducing pain during examinations such as CS while its effect
on cytology adequacy was also assessed to ensure outcome quality.
Four out of five studies affirmed that the use of water-based lubrication was
effective in reducing pain during insertion (i.e. Insertion Phase) of vaginal speculum
and at the same time without influencing the adequacy of cytology (Gungorduk et al.,
2014, Hill & Lamvu, 2012, Simavli et al., 2014 & Uyger et al., 2012). Level of pain
perceived by participants was statistically significantly lower in the IGs than the CGs.
Furthermore, Simavli et al. (2014) and Gungorduk et al. (2014) also validated the
effectiveness of water-based gel lubrication in relieving pain during the dilation phase
of speculum.
24
The study of Gungorduk et al. (2014), being the only study investigating the level
of pain during extraction of speculum in this review, further affirmed that the pain
reduction effect of water-based gel lubrication not only take place during the insertion
and dilation phases of the speculum, it could also last through to the extraction phase of
speculum.
Conversely, Gilson et al.(2006) was the only article suggesting that the use of
speculum lubrication would not make a difference in the discomfort level of the
participants nor interfere with the cytology result.
2.3.2 Data Synthesis
Among all the literature reviewed, the study by Gilson et al. (2006) was singled
out as it is the only one having a different conclusion and a higher number of
unsatisfactory results in the IG. It might be due to the difference in the design of IG and
CG, timing for measuring outcome, tools used for performing cervical smears and the
specific technique required.
Design of IG & CG. In the other four studies, there were only one CG and one IG.
Each participant was randomly allocated to either one of the groups only. However, in
the study of Gilson et al. (2006), two papanicolaou smears were taken for each
participants. The first smear was taken using dry speculum, whereas during the second
25
smear taking, participants were randomly allocated to IG or CG. Such study design
allowed each of the participants to serve as their own control by comparing the rating of
pain from the second smear to that of the first smear. Although a slightly lower score of
pain could still be achieved during the second smears from both the IG and CG, the
results were statistically insignificant (p>0.05) and may be a result of subjective bias.
Taking into consideration that past experience may affect future perception,
participants might already have certain degree of expectation over the discomfort level
of the second papanicolaou smear after the first smear taking and they might be
psychologically better prepared for the second smear. Apart from this, the first smear
might stimulate secretion of natural vaginal discharge that might help to reduce vaginal
dryness and soothe the pain and discomfort during the second smear, hence the results
generated might not be solely due to the intervention alone.
Outcome measurement. Gilson et al. (2006) assessed the level of pain after
finishing the whole CS procedure while the other studies measured the outcome
directly in insertion, dilation or extraction phase. As level of pain might vary drastically
along the three phases of speculum examination, it is believed that a more accurate
result could be generated if the measurement could be done right after speculum
insertion.
26
Spatula Versus Cervex-brush. The study from Gilson et al. (2006) was the earliest
study among all the literatures evaluated in this review. It used traditional method of
conventional cytology in which a wooden spatula was used to collect the ectocervical
cells followed by the collection of endocervical cells using a cytobrush. On the contrary,
Simavli et al. (2014) and Uygur et al. (2012) used “broom-like cervex-brush” for CS in
their studies. Although Gungorduk et al. (2014) and Hill and Lamvu (2012) did not
describe the tools used for specimen collection in details in their studies, they did
mention the type of screening performed being liquid-based cytology in which the use
of cervix brush was preferred while wooden spatula could not be used. As the level of
discomfort exerted from wooden spatula might be different compared to that of
cervex-brush, and since Gilson et al. (2006) measured the outcome after the completion
of examination, the level of pain associated with speculum examination rated by the
participants might include the effect from the wooden spatula as well, such that the
result obtained might not be solely due to the use of water-based gel lubrication.
Specific technique required for conventional cytology. Apart from the difference
in the tools used, the techniques in preserving specimen were also different for
conventional cytology and liquid-based cytology. With conventional cytology, smear
taker has to spread a thin layer of cells onto a glass slide and fix the cells with spray or
alcohol immediately afterwards. During the spreading procedure, cells might easily be
27
obscured by blood or mucus while cell loss during the fixation is not uncommon,
leading to higher rate of unsatisfactory result in the study of Gilson et al. (2006).
2.4 Conclusion
The use of water-based gel lubricant was effective in reducing pain associated
with speculum examination for women undergoing CS without affecting the quality of
cytology outcome (Gungorduk et al., 2014; Hill & Lamvu, 2012; Simavli et al., 2014;
Uyger et al., 2012). It was possible to integrate the innovation into the current practice
under the outpatient clinic setting. It was recommended to set up an evidence-based
practice (EBP) guideline with standardized and updated practice to help reducing
women‟s hesitation for CS checkup so that a higher adherence rate to CSP could be
achieved.
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Chapter 3 - Implementation Potential and Clinical Guideline
In the previous chapters, the affirmed needs and significance of pain control in CS
have been discussed, whereas the literatures reviewed have also been critically
appraised. Implementation potential of the innovation would then be evaluated based
on its transferability, feasibility and its cost-benefit induced as suggested by Polit and
Beck (2004).
3.1 Transferability of the Findings
Target Setting
In HK, women can gain access to CS through hospitals, private clinics, the DH and
several non-governmental organizations such as the Family Planning Association.
Under the DH, there are 31MCHCs and 3 Women Health Centres (WHC) available for
providing CS. CS and family planning are two major service scopes in MCHCs for
women. At the same time, MCHCs can be easily assessed by women who would like to
perform CS as centers are available in all 18 districts in HK. Interested parties can
simply arrange an appointment via phone through a 24-hour hotline. Day-time clinic
setting like MCHC would be perfect for implementing the innovation as CS does not
require admission. For this reason, the innovation was suggested to be firstly
29
implemented in one the MCHCs in the Kowloon district before generalizing it to other
MCHCs.
Target Population
Under the CSP, women aged 25 to 64 who ever had sex were invited to participate
in routine CS (CSP, 2013b). Therefore, women age 25 to 64 attending the designated
MCHC for CS will be included as the target group of the innovation.
Incorporation of Innovation into the Proposed Setting
The main service area of MCHCs includes child health, woman health and
maternal health. CS is one of the major services related to women health as well as
maternal health. Corresponding to the service scope of MCHCs, t the studies appraised
were conducted in Family Practice Clinic (Gilson et al., 2006), the Gynecologic
oncology office of the Gynecology Oncology Department (Gungorduk et al., 2014),
faculty practice (Hill & Lamvu 2012) and the outpatient service of their Obstetrics and
Gynecology Department (Simavli et al. 2014 & Uyger et al. 2012). All of them do share
the same characteristic as an outpatient clinic setting with MCHCs in performing CS.
Hence, the innovation can fit into the MCHC setting and would be able to demonstrate
its efficacy accordingly.
30
Similarity of Target Populations
The targeted population in the selected studies were all women aged at least 18
(Gilson et al. (2006), Hill & Lamvu (2012), Simavli et al. (2014) & Uyger et al. (2012))
to at most aged 77 (Uyger et al. 2012), except the study by Gungorduk et al. (2014) as
the age range is not mentioned specifically. However, the mean age was reported as
52.29 and 54.44 in the CG and IG respectively among the 200 participates (Gungorduk
et al., 2014). Therefore, the target population in the research could fully cover the age
range of that in MCHC, the innovation is considered highly transferable to be
implemented in the MCHC setting.
Philosophy of Care
There is no fundamental difference between the philosophy of care underlying the
innovation and that in the practice setting. The philosophy of care in MCHC includes
promoting the health and wellbeing of women of HK through “developing
evidence-based strategies and programme to meet the changing needs of the
communities” and “providing cost-effective and quality-assured service” with a team
of competent staff (Family Health Service, 2006). Based on the reviewed studies, with
the proposed innovation the pain associated with CS can be reduced at the same time
without affecting the adequacy of cytology. It helps to encourage regular CS and
31
avoids complaints related to discomfort during examination without affecting the
quality of service provided, so as to improve nurses‟ competency and promote health
and wellbeing of the clients. The philosophy of care underlying the innovation is
clearly in line with the prevailing philosophy of MCHCs.
Benefit Sufficient Number of Clients
It is estimated that a sufficient number of clients will benefit from the proposed
innovation. In 2014, a total of 1,243,153 cervical cytology tests were carried out by the
31 MCHCs and 3 WHC under DH (Cervical Screening Programme Annual Statistics
Report, 2014). There were 110,334 CS tests performed under the services provided by
Department of Health in 2014 (Cervical Screening Programme Annual Statistics
Report, 2014). By an estimation based on previous observation, a maximum of 2,860
CS tests can be performed in the designated MCHC proposed for implementation. It is
expected that around 240 women per month visiting the MCHC for CS can gain benefit
from the innovation.
32
Time Frame for Implementation
The expected time required from the preparation, implementation to trial
evaluation of the innovation would be approximately nine months. As the materials
needed such as K-Y Jelly are readily available in the MCHC already, more time will be
allocated to the introducing and explaining of details regarding the implementation to
all medical staff involved, including medical officers, nursing officers, registered
nurses and enrolled nurses at MCHCs. An approval will need to be obtained from the
administrators of the Department Head Office. There will be one medical officer
assigned in the Innovation Committee who will be responsible for the introduction of
the innovation to the administrators to obtain their support and approval. Guideline of
the new innovation will be circulated among the involved medical staff, including
medical officers, nursing officers, registered nurses and enrolled nurses, informing
them about the change of practice and encouraging them to read and learn about the
innovation first. Details of the guideline can be given in one of the weekly meetings.
Medical staff will be encouraged to provide opinions or express their concerns during
the meeting, as well demonstration of the application of KY-Jelly onto the speculum
will be performed during the meeting by members from the Innovation Committee.
Return demonstration are required. Questionnaire used for collecting comments from
medical staff will be designed. The whole preparation period will take approximately
33
three months. Then a pilot test period lasting three months for data collection is
intended before implementing the proposed innovation to all the MCHCs. Data of the
pain and satisfactory level related to the CS will be collected immediately after each
session of screening using a specially designed questionnaire. Lastly, another three
months will be spent for an data analysis and evaluation. Overall, the medical officer in
the Innovation Committee will be the person in-charge of the trial. A Gantt chart
presenting the implementation time frame is attached in Appendix F.
3.2 Feasibility
Autonomy
Around thirteen trained medical officers and nurses, who are qualified to perform
the CS test in MCHC, shall have autonomy to carry out the innovation. The four
remaining non-qualified medical staff will have freedom to assist during the procedures
while waiting for their training to become a qualified smear nurse and then be admitted
to join the new innovation. All the medical staff in MCHC have the freedom to
terminate the innovation if it is considered undesirable. They are also welcomed to
make suggestions and express their concern during the weekly in-service meetings.
34
Interference of current staff and clients
No interference to current staff functions will be caused by the implementation of
the innovation since it fit in perfectly with the current situation of MCHC. No extra
manpower nor time will be incurred as part of the implementation.
Organization and administration support
As stated in the mission of Family Health Service (2006) where MCHC belongs to,
they were aimed to provide cost-effective and quality-assured service with
evidence-based strategies and programme. As such the administration and organization
should be supportive in implementing evidence-based innovation if it is cost-effective
and contributes to the continuous improvement in the quality of service with minimal
interruption to current staff functions (FHS, 2006).
Apart from this, the administrative level of FHS should also be keen in staff
development by providing different kinds of training courses or sponsorships for
eligible staff, so as to encourage and equip staff with up-to-date information and
training to maintain the quality of service provided. Courses on cervical smear taking is
one of the on-going training program examples that train new nurse to perform cervical
smear screening. The implementation of the innovation will also help to update this
35
training with supporting evidence. The current organizational climate appears to be
conducive to our research.
There is a fair degree of consensus among staff and administrator supporting the
innovation. In 2015, the administrator encouraged nurses to replace stainless steel
speculum with plastic disposable speculum for better infection control, as a result an
increasing number of complaints have been received since then from clients concerning
the discomfort felt during cervical smear taking. Many nursing staff also reported that
these complaints affected their competency in performing CS. As a result, the
possibility to apply other kinds of lubrication except normal saline as the usual practice
has been raised. Hence, the proposed innovation is accepted and considered worthwhile
for testing by a majority of the medical staff in MCHC.
Availability of Skills and staff
As the innovation only requires the skill in applying the KY-Jelly to the external
side of the superior and inferior blade of disposable plastic specula, the briefing of the
implementation and the technique demonstration can be integrated into the routine
weekly in-service meetings. No nurses need to be released from their work to learn
about and implement the innovation. Guidelines with photos demonstrating the
application method will be provided at the interview room to provide referencing for
36
the medical staff and facilitate their work. Although not all the nursing staff in the
designated MCHC are eligible to perform CS. The ineligible staff can still participate in
the preparation and evaluation phase of the implementation of innovation. No extra
training cost is needed for them as they will receive training to be a smear nurse as per
their original schedule only with the updated information gathered from this study.
Availability of Equipment and staff
KY-Jelly, photos demonstrating the application method and guidelines are the
only equipment needed. KY-Jelly as a water-based lubrication is already available in
the current setting of MCHC. Extra stock can be made available easily from the
pharmacy of DH. The photo demonstrating the application method and guidelines can
be prepared by the Health Information Section (HIS) of FHS. As equipment required
and staff manpower are kept to a minimum, the implementation of the innovation is
highly practicable in the MCHC.
Availability of Evaluation Tools
A questionnaire with a set of pain assessment tool will be required to collect data
on pain levels during the evaluation process. Visual Analog Scale (VAS) or simply the
idea of a numeric scale will be chosen as the set of pain assessment as majority of the
37
selected literature also used VAS or numeric scale as their screening tools (Gungorduk
et al, 2014, Hill & Lamvu, 2012, Simavli et al., 2014 & Uyger et al., 2012). The pain
assessment tools can be prepared and supplied by the Health Information Section in the
head office of FHS.
3.3 Cost-Benefit Ratio
Potential risks
During the implementation of the innovation, clients may be affected by a
decrease in cytology quality as in the actual practice of the designated MCHC.
However, evidence from the research studied suggested that the risks could be
eliminated with the use of liquid-based cytology. Evidence are presented and graded in
Appendix I.
Potential benefits
There are expected potential benefits to both clients and medical staff. With the
use of KY-Jelly, clients‟ anxiety and discomfort encountered during CS is expected to
decrease. By reducing pain and discomfort, it may also help to encourage adherence to
the checkup schedule. With a higher satisfactory rate from the client, the stress of
medical staff can be released. Increase in nursing competence with a decrease in clients‟
38
anxiety level can smoothen the CS procedure. Hopefully, time can be saved in
consultation and the screening procedure as well.
Risks of maintaining the current practice
If the current practice is maintained, a continuous increase in the number of
complaints related to quality of service is anticipated. With a poor experience
encountered, it may affect clients‟ perception to the future medical checkup. They may
be reluctant to attend physical checkups even it is indicated. Possible complaints caused
by the current practice may lead to a decrease in nursing competency as well. It will
violate the mission of FHS under DH, which is to “build a team of competent staff” and
to “provide quality-assured service” (Family Health Service, 2006).
Material Costs of the Innovation
The material costs of the innovation mainly derived from the supply of KY-Jelly
and printing or photocopying of guideline and evaluation form. The retail price of
KY-Jelly is approximately Hong Kong dollar (HKD) $15 per tube. Each tube can be
used for around 3 sessions if the quota are all fully booked. As under the policy of DH
and FHS, MCHC opens on weekdays, as well as every second and forth Saturday of
each month. There are three sessions of CS per week plus two other screening sessions
39
on Saturday with different quota being set depends on service hours. Considering Year
2015 and quota set in the designated MCHC as an example, there are maximum of 180
sessions per year (i.e. 45 sessions per three months). Therefore, the cost of supplying
KY-Jelly is estimated to be HKD $225 per three months. Furthermore, a three pages
Guideline including one page of pictures demonstrating the exact location of
application of KY-Jelly on the plastic disposable speculum and one page of evaluation
form are to be prepared as well. Photocopying at a price of HKD $0.3 is estimated.
After detailed calculation as shown in Appendix H, the total material cost for the new
innovation is HKD $270.
Non-material Costs of the Innovation
Non-material costs mainly due to the time consumed on new staff training and
skills reviewing of the existing smear taker. However, there is actually no extra cost
need to be spent on new staff training. As even without the implementation of the
proposed innovation, FHS will organize course for training new staff to be a smear
taker from time to time. The new innovation can be integrated with the original training
schedule and act as an updated course material if the implementation is successful,
meanwhile the medical staff who are not eligible for performing CS will be allocate to
the preparation and evaluation phase. On the other hand, in the existing practice, it is
40
suggested that the use of water-based lubrication with the ingredient of “carbomers” or
“carbopol polymers” may increase the risks of obscuring the cytological interpretation
of CS. Although KY-Jelly is one of the water-based lubricate which does not contain
“carbomers” nor “carbopol polymers” and Uyger et al (2012) also supported that
KY-Jelly would not affect the adequacy of specimen sample, medical staff participated
in the innovation may have concern and worry over this issue. A demonstration and
return demonstration as a skill reviewing and assuring session will be held by one of the
Nursing Officer. It is expected to last for one hour. Photos with the correct site of
application will be provided in the interview room for staff reference in the future
(Appendix K).
However, implementation may encounter slight friction as the time of weekly
service meeting may be lengthened due to explanation, demonstration and evaluation
of the new innovation. It also takes time for all the staff to return demonstrate the skill
of application of KY Jelly on the speculum.
Costs of Not Implementing the Innovation
If the innovation is not implemented, a continuous increase in the number of
complaints related to quality of service as mentioned before is foreseen. Longer
consultation time may be needed in order to explain the possible cause of discomfort
41
and to comfort the clients. A poor experience in CS may break the rapport between
clients and medical staff, hence, staff‟s competency and coverage rate of CS maybe
lowered.
Potential nonmaterial benefits of the implementation
The new innovation allows a clearer guidance for medical staff in performing CS.
A smooth and successful CS can help to build up better rapport between clients and
medical staff. It may also help to maintain or increase the coverage rate of CS in the
community. Hopefully, the vision of FHS which is “to lead the community in
promoting the health and well-being of children, women and families in HK” (Family
Health Service, 2006) can be achieved with this very first step in MCHC.
3.4 Developing an EBP Guideline
An Evidence-based Practice (EBP) Guideline is developed with a proper title,
clearly stated aim and objectives. Intended target users and target group are defined to
provide guidance, facilitate future implementation and effective communication among
medical staff. In the guideline, recommendations are made with the support of evidence
from five review studies. They are graded by using the Levels of Evidence and the
Grades of Recommendations suggested by Scottish Intercollegiate Guidelines Network
42
(SIGN, 2014), so that the evidence derived from the research studies can be presented
systematically regarding the quality of evidence or strength of recommendations (SIGN,
2014). The criteria for allocating the Levels of Evidence and Grades of
Recommendations are listed in Appendix C and Appendix J respectively while the
complete version of the EBP guideline is demonstrated in Appendix I.
43
Chapter 4: Implementation Plan
After affirming the needs of the new innovation and investigating the possibility in
implementing the innovation regarding to its transferability, feasibility and cost
effectiveness, a communication plan will be set up. It acts as a guide for stakeholders to
facilitate the process of change. It is tailored to ensure the innovation is feasible to
implement.
4.1 Communication Plan
There are a number of parties involved in initiating and sustaining a change. All
the changes related to the proposed innovation will begin with the direction from top
to down. All the stakeholders involved in this process can be classified into three
levels. They are managerial level, clinical level and client level.
Managerial Level
Members in the managerial level of Family Health Service (FHS), which MCHC
belongs to, under Department of Health include Principal Medical Officer, Senior
Medical Officer, Principal Nursing Officer, Chief Nursing Officer and District Senior
Nursing Officer. Approval from this party is crucial before initiating any changes and
44
implementing any new innovation. Progress of the plan and control budgets may need
to be reported to the managerial level from time to time.
Clinical Level
Under the clinical level, the frontline staff in the designated MCHC will all be
included. All the staff in the corresponding MCHC including Medical Officer,
Nursing Officer, Registered Nurse, Enrolled Nurse, clerical staff, Workman and
Pharmacy Unit are all involved in the implementation process.
Although Workman and clerical staff are not the one who directly delivers the
service with speculum examination, they still need to be kept up-to-date with any
changes. Workman can assist in keeping stocks of instrument such as plastic
disposable speculum, normal saline and KY-Jelly. Clerical staff will help to
photocopy, distribute and collect the questionnaire for evaluation.
Client level
Female clients returning and fulfilling the requirements for performing CS in
MCHC belongs to this level. As they are the end users who receive benefit if the
innovation is feasible and transferable in the future, their comments are vital to the
evaluation of the innovation.
45
4.1.1 Initiating the change
To begin with, an Innovation Committee will be set up. One Medical Officer,
one Nursing Officer and two nurses who are already qualified to perform CS, namely
Smear Nurse, in the clinical level are invited to join the Innovation Committee. The
Medical Officer will be the leader in the committee. Nurses in the committee will be
responsible for drawing up a proposal so as to introduce the new innovation. They
will emphasize the significance of the issue and affirming the needs to change with
the support from literature reviewed inside the proposal. The transferability,
feasibility, an estimated budget with a comparison of total cost and benefit will also
be stressed. The Medical Officer will provide feedback and the committee will do the
final amendment before presenting the ideas to the Managerial Level of FHS. A face
to face presentation is expected to be done by the Innovation Team in the Head Office
of FHS. With the approval and support from the managerial level, the Team will
initiate the changes in the designated MCHC.
46
4.1.2 Sustaining the changes
The Innovation Team will then become the Communication Team as well. They
facilitate effective communication among different stakeholders throughout the
implementation process. They are responsible for reporting the progress of the
implementation to the managerial level from time to time. At the same time, they will
be leading all the clinical staff in initiating and sustaining the changes. If there were
any problems encountered during the process, they would be discussed during the
weekly clinic meetings. Refinement of guideline and update on information will be
delivered to all the staff through the weekly clinic meeting too. The Communication
Team will gather the comments and discussed with the managerial level through
internal email system and regular meeting around once per month.
4.2 Pilot Study Plan
After seeking ethical approval from the administrators in the managerial level of
FHS, it is planned to carry out a pilot study in one of the MCHC first in order to
explore the feasibility of implementation before generalizing it to all the MCHCs. It is
expected to last for around three months. According to the working schedule of the
designated MCHC, there will be three CS sessions from Monday to Friday each week
and one more session on alternate Saturday. By estimation with four weeks in a
47
month, there will be 42 CS sessions including sessions on alternate Saturday. A
maximum of 666 subjects can be recruited in 3 months‟ time.
4.2.1 Material Required
Water-based lubricants – KY Jelly, photos in demonstrating the application of
lubrication and three sets of questionnaire involved in the whole study are required in
this Pilot Study.
Corresponding to the EBP Guideline in Appendix I, water-based lubrication
without Carbomers is to be used. Under the setting of the designated MCHC it will be
probably KY-Jelly. As KY-Jelly is an essential lubricant required in other kinds of
examination provided in MCHC such as antenatal checkup, it is already readily
available in the centre. Pharmacy Unit will be informed for the possible increase in
consumption of the KY-Jelly two months before implementation of the proposed
innovation, so as to maintain a regular and stable supply of KY-Jelly throughout the
implementation period.
A photo (Appendix K) demonstrating the suggested location for applying
KY-Jelly will be prepared by the Innovation Team. To play safe, KY-Jelly is advised
to be applied sparingly and only on the exterior surface of the speculum, avoiding the
tip to reduce the risks of contaminating the cervix even though it is suggested
48
carbomers-free lubrication does not interfere the cytological interpretation (Rosa,
Pragasam, Saremian, Aoalin, Graf & Mohammadi, 2012; Feit & Mowry, 2011; Lin,
Taylor, Alperstein, Hoda & Holcomb,2014). Five copies of the photo will be prepared.
Two will be used for the demonstration and skill review session during the
introduction of the innovation and staff training. The remaining three will be placed
one each in the two Rooms of Medical Officer and the CS Room of Nurses for easy
reference.
A total of three questionnaires will be designed for this Pilot Study. The first
Questionnaire – Questionnaire for all Medical Staff (Appendix L) will be provided to
all the medical staff after the staff training session. It is used to collect comments from
them to review the performance of the innovation team in delivering the significance
and affirming the needs of proposed innovation, the usefulness and clarity of the
training session with the photos prepared.
The second Questionnaire – Satisfaction & Self-reflected Competence
Questionnaire (Appendix M) will be available for the smear taking medical staff only
at the end of the implementation period. It is used to collect their feedback on the
logistics of the implementation process and their self-reflected competence with the
new innovation.
49
The last set of questionnaire – Satisfaction Questionnaire for Participant
(Appendix N) will be distributed to the participants after undergoing the CS with the
proposed innovation. Their perceived pain level during the process and overall
satisfaction on staff performance will be explored.
4.2.2 Training for Medical Staff
The training of medical staff will begin after seeking the approval from the
administrators and is expected to complete within one month. It is actually a skill
refining session rather than training session for smear takers. In the practice of MCHC,
courses for training new staff to be a smear taker will be organized from time to time. In
the meanwhile, there are a total of 2 Medical Officers, 4 Nursing Officers and 11
nursing staff in the designated MCHC. As 13 of them are qualified smear takers, there
are sufficient smear takers for running the pilot study with three to four screening
sessions per week. It is not necessary to provide extra training for new staff in this
stage. Training on refining the skills of KY-Jelly application can be integrated into the
routine weekly in-service meeting. There will be around 4 in-service meetings within a
month. Each of the staff will receive an EBP Guideline. Photos demonstrating the
application method as mentioned above will be used to assist the demonstration.
Background information on the significance and affirming the needs for the changes
50
and demonstration on the application method of KY-Jelly will be performed by the
innovation team in the first two sessions. The third and fourth session will be used to
review the application skills of the current smear taker by the Nursing Officer in the
Innovation Team. Five minutes is expected for reviewing one of the staff. As a result,
only 50 minutes is needed to complete reviewing the skills for all the smear takers in the
designated MCHC. Staff who are not smear takers will participate in the preparation
and evaluation phase of the implementation. Therefore, it is essential for them to attend
all the meetings and knowing the details of the innovation. Questionnaire (Appendix L)
will be distributed to all the medical staff at the end of the forth meeting. Comments
from both smear taker and non-smear taker are valuable in refining the clinical
guideline and future operation.
4.2.3 Logistics
The pilot study will commence once after the training sessions completed. Within
the 3 months‟ time, clerical staff will help to prepare enough questionnaires for the
clients according to the numbers of booking for CS before each CS session. Workmen
will be reminded to check on the stock of KY-Jelly and arrange one tube of KY-Jelly
for each session. Smear Takers will distribute the questionnaires to the clients before
they undergo the screening test with the innovation, as pain is to be rated with the
51
speculum insertion, dilation and extraction. A collection box will be provided in the
lobby for clients to return the completed questionnaire before they leave. The
non-smear taking nursing staff will help to gather the questionnaire inside the
collection box when the session ends. After 3 months of formal implementation, Smear
takers will be provided with the final questionnaire (Appendix M) in the weekly service
meeting to collect their comments on the logistics and most importantly their
self-reflection on nursing competency. Other staff will also be invited to express their
opinion during the service meeting. The clinical guideline will be modified according
to the pilot results and the feedback collected. The process of data analysis and refining
of clinical guideline are expected to be c in two months. The report will then be sent to
the managerial level to justify the feasibility of the innovation.
Evaluation Plan
After 3 months of implementation with the pilot study plan, another plan will be
set up for evaluating the effectiveness of the innovation to the clients, healthcare
professional and the current health care system. The outcome, measurement tools, time
for measure and adequacy of sample size will be specified to guide along the evaluation
process.
52
Client Outcome
The primary outcome evaluated is the level of pain experienced by the participants
related to CS. With respect to the literature reviewed, the timing to be rated will be set
as during insertion, dilation and extraction of speculum. Pause will be given to client in
between each phase. It is set because four out of the five literature reviewed evaluate
pain due to insertion of speculum. (Gilson et al. 2006, Gungorduk et al. 2014, Hill &
Lamvu, 2012 & Simavliet al. 2014) One of them assessed the pain level related to
insertion and opening of speculum (Simavli et al., 2014). Literature written by
Gungorduk et al. (2014) even included the extraction phase. Furthermore, pain is a
subjective feeling. Visual Analog Scale (VAS) will be used to assess and quantify the
level of pain. A ten-centimeter VAS is used. It ranges from 0 to 10. Zero indicates no
pain at all while 10 indicates the worst pain imaginable. VAS is considered as a
validated and reliable instrument for assessing pain as two out of five of the reviewed
studies used VAS (Gungorduk et al., 2014 & Hill & Lamvu, 2012). Although the
remaining three studies either using the “Wong-Baker Faces Pain Rating Scale” (Gilson
et al., 2006) or do not mention the name of the scale chosen, they are all using
self-reported numeric scale from 0 to 10 which is of the same structure as VAS. Rating
will be given by participants in the insertion, dilation and extraction phase during
examination with pause in between.
53
Secondary Outcome considered is the efficacy of liquid-based cytology screening
result even the lubrication used is altered. Number of unsatisfactory samples will be
recorded for each session. A comparison will be made with the overall percentage of
unsatisfactory samples after 3 months of implementation and that before the
implementation take place.
Healthcare Professional Outcome
The lubricant application skills of the smear takers will be assessed once only
before the implementation of the innovation. They are to be assessed one-by-one and
face-to-face by a Nursing Officer. Samples of plastic vaginal speculum and KY-Jelly
will be provided for assessment.
Satisfactory level and self-reflected competence level of the smear takers will be
assessed at the end of implementation period. Information will be collected through the
format of questionnaire (Appendix M) and distributed to the medical staff at the end of
implementation period. With a deeper understanding to the feeling and concern of the
frontline staff, improvement can be made accordingly when generalizing the
innovation to all the MCHC in the future. The compliance to the new innovation can
also be sustained.
54
System Outcome
To evaluate the system effectiveness, the money cost and change in level of
workload perceived by the medical staff will be assessed. With the anticipated increase
usage of KY-Jelly and decrease usage of normal saline, the total cost will be calculated
and compared to that of the previous practice. As no extra manpower or non-office hour
training are required for this pilot study, actual change in level of workload perceived
and total cost will be considered.
4.3 Evaluation Plan
4.3.1 Sample Size
The sample size is calculated depending on the primary outcome measured. By
referring to the reviewed studies, VAS score deviation can be reduced by 25% to
around 35% during the insertion of speculum with water-based lubricant like KY-Jelly
applied (Gungorduk et al, 2014 & Hill & Lamvu, 2012). As a result, to be more
conservative, it is considered that a decrease of 1 unit in the VAS will suggest
effectiveness of the innovation. By using Piface, an online electronic statistical
application, with one-sample t-test, the assuming effect size is 1 while the standard
deviation of 2.5, given the power to be 0.8 and the confidence level to be 0.05, the
estimated sample size will be 51 (Lenth, 2009). By taking into consideration 10% of the
55
participants may dropout and refuse to fill in the questionnaire, the resultant sample
size becomes 60. As all clients who are qualified to undergo CS in MCHC are eligible
to participate in this pilot study, participants will be recruited using convenient
sampling. Recruitment is expected to continue in all CS session throughout the 3
months implementation period due to the fact that the utilization rate of CS in the
designated MCHC may be as low as 30% in 2015. Attendance may be affected by many
unanticipated factors, such as advertisement from private company, news of a celebrity
being diagnosed with cervical cancer.
4.4 Basis for Implementation
Client outcomes
According to the reviewed studies, the VAS mean score is reduced by 20% after
the application of water-based lubrication such as KY-Jelly (Gungorduk et al, 2014 &
Hill & Lamvu, 2012). Taking into account their result as a reference with a conservative
estimation, a drop of 10% is regarded as effective in this pilot study.
Healthcare Provider Outcomes
The innovation will be considered effective and eligible for full implementation if
over 70% of nurses reported “strongly agree” or “agree” for all items in the satisfaction
questionnaires.
56
System Outcome
The increase in monetary cost not exceeding 10% with over 70% of nurses
reported “strongly agree” or “agree” for items related to the level of workload in the
satisfaction questionnaires will be sufficient to prove the effectiveness of the proposed
innovation.
Conclusion
Published studies supported that the use of water-based lubrication which are
carbomers-free, such as KY-Jelly, is effective in reducing pain for client during CS
procedure without affecting the quality of the liquid-based cytology. Pilot study can be
carried out in order to evaluate the transferability and feasibility of the proposed
innovation, which would facilitate the generalization of such innovation into other
MCHCs in the future. The development of an evidence-based guideline and a
communication plan can provide guidance and support for the stakeholders throughout
the pilot study.
57
Citation /
Design
(Study quality)
Sample characteristics Intervention(s) Control Outcomes
(Assessment Time)
Effect Size
(Intervention – Control)
Gilson et al.
(2006) /
RCT (1+)
1) Female patients
(100%)
2) Attend for cervical
cancer screening in
a Family Practice
Clinic
1) All participant will
undergo the first smear
by using a dry
speculum
(No Gel, n=70)
2) Second Smear done
with external side of a
disposable plastic
vaginal speculum
lubricated with 2.7g
water-based lubricant
(Gel, n= 40)
1) All participant will
undergo the first
smear by using a dry
speculum
(No Gel, n=70)
2) Second Smear done
by using dry
Speculum / water
being applied to the
speculum
(No Gel, n= 30)
Primary Outcome:
1) Unsatisfactory smear
2) Satisfactory smear
Secondary Outcome:
3) Pain
- Self-reported
- Wong-Baker Faces Pain
Rating Scale: 0-10
a) 2nd
Gel Vs 2nd
No Gel
b) 1st No Gel Vs 1
st No Gel
c) 1st No Gel Vs 2
nd Gel
d) 1st No Gel Vs 2
nd No Gel
1) Difference in number
of cases: 2 (p=0.5)
2) Difference in number
of cases: 6 (p>0.05)
3a) Mean: 0.1 (p=0.69)
3b) Mean: -0.3 (p=0.45)
3c) Mean: -0.5 (p=0.57)
3d) Mean: -0.3 (p=0.57)
Gungorduk et
al. (2014) /
RCT (1+)
1) Female patients
(100%)
2) Attend for
speculum
examination in the
Gynecology
Oncology
Department
3) Mean age
i) Intervention
Group =
52.29yrs (SD =
7.98)
ii) Control Group
= 54.44yrs (SD
= 8.71)
External side of the
superior and inferior blade
and distal tip of a
disposable plastic vaginal
speculum lubricated with
6.5mL gel lubricant
(n= 98)
6.5mL tap water was
applied to the speculum
(n= 97)
Primary Outcome:
1) Pain
- Self-reported
- VAS: 0-10
a) Insertion Phase
b) Dilation Phase
c) Extraction Phase
1a) mean: -1.33
(p<0.001)
1b) mean: -0.78
(p=0.001)
1c) mean: -0.9 (p<0.001)
Appendix A – Table of Evidence
58
Hill & Lamvu
(2012) /
RCT (1++)
1) Premenopausal
female patients
(100%)
2) Attend for cervical
cancer screening in
the Obstetrics and
Gynecology
Department
3) Mean age
i) Intervention
Group =
38.2yrs (SD
= 6.4)
ii) Control Group
= 36.3yrs (SD =
6.8)
Distal tip of a disposable
plastic vaginal speculum
lubricated with 3mL gel
lubricant
(n= 59)
Using dry Speculum
(n= 60)
Primary Outcome:
1) Pain
- Self Reported
- VAS: 0-10
Secondary Outcome:
2) Unsatisfactory smear
1a) mean: -0.74
(p<0.011)
2) No difference
Simavli et al.
(2014) /
RCT (1+)
1) Female patients
(100%)
2) Attend for cervical
cancer screening in
the Obstetrics and
Gynecology
Department
3) Mean age
i) Intervention
Group =
39.8yrs (SD =
11.9)
ii) Control Group
= 39.7yrs
(SD = 11.2)
External side of the
superior and inferior blade
of a disposable plastic
vaginal speculum
lubricated with a small
amount of water-based
lubricant
(n= 790,
570 premenopausal
women, 220
postmenopausal women)
Using dry Speculum
(n= 790,
570 premenopausal
women,
220 postmenopausal
women)
Primary Outcome:
1) Pain
- Self Reported
- Numeric Pain Scale: 0-10
a) For all participant
i) Insertion Phase
ii) Opening Phase
b) Premenopausal women
i) Insertion Phase
ii) Opening Phase
c) Postmenopausal women
i) Insertion Phase
ii) Opening Phase
Secondary Outcome:
2) Unsatisfactory smear
1ai) median: -1 (p<0.001)
1aii) median: -2
(p<0.001)
1bi) median: -1 (p<0.001)
1bii) median: -2
(p<0.001)
1ci) median: -1 (p<0.001)
1cii) median: -1
(p<0.001)
2) -2 (p=0.8)
59
Footnote: RCT = Randomized controlled trial; SD = Standard deviation; VAS = Visual Analog Scale
3) Satisfactory smear 3) 2 (p=0.98)
Uyger et al.
(2012) /
RCT (1+)
1) Female patients
(100%)
2) Attend for cervical
cancer screening in
the Obstetrics and
Gynecology
Department
3) Mean age
i) Intervention
Group = 44.7yrs
(SD = 12.4)
ii) Control Group =
45,7yrs
(SD = 11.5)
External side of the inferior
blade of a disposable
plastic vaginal speculum
lubricated with a
dime-sized amount of
water-soluble lubricant
(n= 200,
100 with Conventional
Cytology, 100 with
Liquid-Based Cytology,
Premenopausal= 125,
Postmenopausal = 75)
Warm water was applied
to the speculum
(n= 200,
100 with Conventional
Cytology,
100 with Liquid-Based
Cytology,
Premenopausal = 121,
Postmenopausal = 79)
Primary Outcome:
1) Pain
- Self Reported
- Numeric Pain Scale: 0-10
a) For all participant
i) Insertion Phase
b) Premenopausal women
i) Insertion Phase
c) Postmenopausal women
i) Insertion Phase
Secondary Outcome:
2) Specimens lacking of
Endocervical / Transformation
zone
a) Conventional Cytology
b) Liquid-based Cytology
3) Unsatisfactory smear and
abnormal cell
1ai) mean: -0.7 (p<0.05)
1bi) mean: -0.2 (p=0.25)
1ci) mean: -1.5 (p<0.005)
2a) Difference in number
of cases: -4%
(p>0.05)
2b) Difference in number
of cases: -8%
(p>0.05)
3) Difference in number
of cases: 1
60
,
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Gilson, M., Desai, A., Cardoza-favarato, G., Vroman, P. & Thornton, J. A. (2006). Does gel affect cytology or comfort
in the screening papanicolaou smear?. Journal of the American Board of Family Medicine 19 (4), 340-344.
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):
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.
P: Women presenting for an annual gynecologic examination
I: Use of water-based lubricating gel before speculum insertion
C: Medical Center Family Practice Clinic
O: Associated pain and cervical cytology accuracy
Yes
Can‟t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Subjects were assigned by using a computer-generated random
number table.
Yes
Can‟t say
No
1.3 An adequate concealment method is used.
No specific information was provided in the content about the
concealment method.
Yes
Can‟t say
No
1.4 The design keeps subjects and investigators „blind‟ about treatment
allocation.
Cytotechnologists and patients were blinded to the group
assignments.
All Papanicolaou smears were performed by one of five physicians
in the clinic.
Yes
Can‟t say
No
1.5 The treatment and control groups are similar at the start of the trial.
No significant relationship was found between group assignment
(GEL vs. NO GEL) and any of the demographic characteristics.
Yes
Can‟t say
No
Appendix B - 1
61
1.6 The only difference between groups is the treatment under investigation.
In all patients, same kind of speculum was being used and insertion
was performed in the same way except the lubrication used.
Yes
Can‟t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Primary outcome is measured by the Wong-Baker Faces Pain Rating
Scale.
Yes
Can‟t say
No
1.8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was completed?
All the subjects in both groups
completed the study.
1.9 All the subjects are analysed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
All participants randomized into the trial were analysed.
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.
There is only one site.
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 (+)
Low quality (-)
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?
Yes
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.
The use of water-soluble lubricating gel in the collection of the traditional Papanicolaou smear did not interfere
with the cervical cytology results nor did it make a difference in the discomfort level of the patients.
62
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Gungorduk, K., Ozdemir, A., Gokcu, M. & Sanci, M. (2014). Does lubrication of the vaginal speculum reduce pain
during a gynecologic oncology examination?. European Journal of Obstetrics & Gynecology and Reproductive
Biology, 184 (2015), 84-88.
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):
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.
P: Women underwent speculum examination for surveillance of malignant
gynecologic disease including cervical cancer
I: Use of water-based lubricant before speculum insertion
C: The Department of Gynecologic Oncology
O: Associated pain
Yes
Can‟t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Randomization was done using a computerized randomization chart
generator.
Yes
Can‟t say
No
1.3 An adequate concealment method is used.
No specific information was provided in the content about the
concealment method.
Yes
Can‟t say
No
1.4 The design keeps subjects and investigators „blind‟ about treatment
allocation.
The patients and clinicians were aware of the treatment allocation
scheme.
Yes
Can‟t say
No
1.5 The treatment and control groups are similar at the start of the trial.
Participants in both groups had similar demographic characteristics
without any significant difference, in terms of age, type of surgery,
time from disease diagnosis, during of menopause, vaginal length or
sexual activity. A similar number of patients in each group
underwent radiotherapy.
Yes
Can‟t say □
No
Appendix B – 2
63
1.6 The only difference between groups is the treatment under investigation.
In all patients, same kind of speculum was being used and insertion
was performed in the same way except the lubrication used.
Yes
Can‟t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
The primary outcome measure was the Visual Analog Scale score
reported for the pain felt during speculum insertion.
Yes
Can‟t say
No
1.8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was completed?
Intervention group:
2/100 x 100% = 2%
Control group:
3/100 x 100% = 3%
1.9 All the subjects are analysed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
Analysis of participants was done according to the actual
interventions received.
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.
There is only one site.
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 (+)
Low quality (-)
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?
Yes
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.
The use of lubricating gel decreases the pain associated with the insertion, dilation and extraction of
speculum during the speculum examination in gynecologic oncology patient.
64
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Hill, D. A & Lamvu, G. (2012). Effect of lubricating gel on patient comfort during vaginal speculum examination: A
randomized controlled trial. American College of Obstetricians and Gynecologists, 119(2), 227-231.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider:
3. 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+
4. 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):
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.
P: Women required vaginal speculum examination
I: Use of lubricating gel before speculum insertion
C: The Obstetrics and Gynecology Department
O: Associated pain
Yes
Can‟t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Subjects are assigned to either intervention or control group by using
a permuted-block, computer-generated schedule using blocks of
four.
Yes
Can‟t say
No
1.3 An adequate concealment method is used.
Randomization results were sealed in opaque envelopes in sequential
order unknown to the investigator or study participants.
Yes
Can‟t say
No
1.4 The design keeps subjects and investigators „blind‟ about treatment
allocation.
Women and all medical staff, including the cytologist but not
including the primary physician and the nurse, were blinded to gel
use.
To prevent participants from determining which study arm they were
allocated to, the investigator prepared every speculum using the
preloaded syringe below a privacy drape.
Yes
Can‟t say
No
1.5 The treatment and control groups are similar at the start of the trial.
Participants in both groups had similar demographic characteristics
without any significant difference, in terms of age, menopausal
status, parity and use of contraceptives.
Yes
Can‟t say □
No
Appendix B – 3
65
1.6 The only difference between groups is the treatment under investigation.
A single examiner performed a speculum examination for all
participants using a standardized protocol that was identical for each
participant to decrease interobserver variability.
Yes
Can‟t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
Primary outcome is measured by the Visual Analog Scale.
Yes
Can‟t say
No
1.8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was completed?
Intervention group:
1/60 x 100% =1.67%
Control group: 0%
1.9 All the subjects are analysed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
The author claimed that “the outcomes for each participant were
analysed in the group to which they were assigned, regardless of
whether or not that participant completed the study”, but finally only
59 participants were analysed in the intervention group rather than
60 due to 1 withdrew consent.
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.
There is only one site.
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 (+)
Low quality (-)
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?
Yes
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.
The use of lubricating gel decreases the pain associated with the insertion of speculum without affecting
the adequacy of cytology.
66
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Simavli, S., Kayguauz, I., Kmay, T. & Cukur, S.(2014). The role of gel application in decreasing pain during speculum
examination and its effects on papanicolaou smear results. Arch Gynecol Obstet, 289: 809-815.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider:
5. 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+
6. 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):
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.
P: Women participating in cervical cancer screening
I: Use of water-based lubricant before speculum insertion
C: The Obstetrics and Gynecology Department
O: Associated pain and Papanicolaou Test accuracy
Yes
Can‟t say
No
1.2 The assignment of subjects to treatment groups is randomised.
Randomization was done in the Obstetrics and Gynecology
Department by the gynecology polyclinic secretary. Subjects were
randomly assigned according to the permuted block method. During
reaction of the allocation list, blocks were chosen randomly using
computer-generated random numbers.
Yes
Can‟t say
No
1.3 An adequate concealment method is used.
No specific information was provided in the content about the
concealment method.
Yes
Can‟t say
No
1.4 The design keeps subjects and investigators „blind‟ about treatment
allocation.
The patients were blinded as to their group assignment and all
medical staff, except the primary physician, were blinded to gel use.
Patients were asked by a blinded member of the medical staff to rate
their pain.
Cytopathologists were blinded against lubricant use during the
specimen collection.
Yes
Can‟t say
No
Appendix B – 4
67
1.5 The treatment and control groups are similar at the start of the trial.
Participants in both groups had similar demographic characteristics
without any significant difference, in terms of age, gravida, parity,
sexual activity, dyspareunia, smoking, habit, use of oral
contraceptive or intrauterine device.
Yes
Can‟t say □
No
1.6 The only difference between groups is the treatment under investigation.
In all patients, same kind of speculum was being used and insertion
was performed in the same way except the lubrication used. The
duration of gynecologic exam was the same in both groups.
Yes
Can‟t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
The primary outcome measures used is a 0-10 numeric pain scale
Yes
Can‟t say
No
1.8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was completed?
All the subjects in both groups
completed the study.
1.9 All the subjects are analysed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
The outcomes for all participants were analysed in the group to
which they were assigned.
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.
There is only one site.
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 (+)
Low quality (-)
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?
Yes
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.
The application of a small amount of water-based lubrication decreases the pain associated with the
insertion and opening of speculum in both premenopausal and postmenopausal women without affecting
the cytology result.
68
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Uyger, D., Guler, T., Yayci, E., Atacag, T., Comunoglu, C., & Kuzey, G. M. (2012). Association of speculum
lubrication with pain and papanicolaou test accuracy. Journal of the American Board of Family Medicine, 25 (6),
798-804.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider:
7. 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+
8. 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):
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.
P: Women underwent speculum examination for surveillance of malignant
gynecologic disease including cervical cancer
I: Use of water-soluble lubricant before speculum insertion
C: The Cervical Cancer Screening Unit of the outpatient unit of the
Obstetrics and Gynecology Department
O: Associated pain and Papanicolaou Test Accuracy
Yes
Can‟t say
No
1.2 The assignment of subjects to treatment groups is randomised.
A block randomization method with blocks of 4 was used. During
the creation of the allocation list, blocks were chosen randomly using
computer-generated random numbers.
Yes
Can‟t say
No
1.3 An adequate concealment method is used.
No specific information was provided in the content about the
concealment method.
Yes
Can‟t say
No
1.4 The design keeps subjects and investigators „blind‟ about treatment
allocation.
Women and all medical staff, including the cytologist but not
including the primary physician and the nurse, were blinded to gel
use.
Yes
Can‟t say
No
Appendix B – 5
69
1.5 The treatment and control groups are similar at the start of the trial.
Participants in both groups had similar demographic characteristics
without any significant difference, in terms of age, menopausal
status, parity and use of oral contraceptives.
Yes
Can‟t say □
No
1.6 The only difference between groups is the treatment under investigation.
In all patients, same kind of speculum was being used and insertion
was performed in the same way except the lubrication used.
Yes
Can‟t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
The primary outcome measure was a numeric rating scale (from
0-10) reported for the pain felt during speculum insertion.
Yes
Can‟t say
No
1.8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was completed?
All the subjects in both groups
completed the study.
1.9 All the subjects are analysed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
The outcomes for all participants were analysed in the group to
which they were assigned.
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.
There is only one site.
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 (+)
Low quality (-)
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?
Yes
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.
The use of a small amount of water-soluble lubricating gel decreases the pain associated with the
insertion of speculum without obscuring the cytological interpretation of both conventional cytology and
liquid-based cytology.
70
Appendix C
SIGN Grading System (1999-2012)
Level of Evidence
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 bias
2++ 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 causal
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 series
4 Expert opinion
71
Iden
tifi
cati
on
Appendix D - PRISMA 2009 Flow Diagram
Records after duplicates removed
(n = 247 )
Incl
uded
Records identified through
database searching
(n = 149 )
Scr
eenin
g
Eli
gib
ilit
y
Full-text articles excluded,
with reasons:
Studies on adolescents
Subjects undergoing other
gynecological treatment
Studies focused on
cytology adequacy only
(n = 66 )
Studies included in quantitative
synthesis (meta-analysis)
(n = 5 )
Records excluded
(n = 165 )
Full-text articles assessed
for eligibility
(n = 71 )
Records screened
(n = 82 )
Additional records identified through
other sources
(n = 109 )
From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 6(6): e1000097. doi:10.1371/journal.pmed1000097
For more information, visit www.prisma-statement.org.
72
Appendix E - Quality Assessment Using SIGN Methodology Checklist for Controlled Trials
Section 1: Internal Validity
Citation 1:
Gilson et al. (2006)
Citation 2:
Gungorduk et al. (2015)
Citation 3:
Hill & Lamvu. (2012)
Citation 4:
Simavli et al. (2014)
Citation 5:
Uyger et al. (2012)
Clearly Focused
Question
Yes Yes Yes Yes Yes
Randomization Yes Yes Yes Yes Yes
Allocation
Concealment
Can‟t say Can‟t say Yes Can‟t say Can‟t say
Blinding Can‟t say No Can‟t say Can‟t say Can‟t say
Comparable Groups Yes Yes Yes Yes Yes
Treatment is the
Only Difference
Yes Yes Yes Yes Yes
Valid and Reliable
Outcome Measures
Yes Yes Yes Yes Yes
Drop-Out Rate 0% for both group IG: 2% CG: 3% IG: 1.67% CG: 0% 0% for both group 0% for both group
Intention to Treat
Analysis
Yes No No Yes Yes
Comparable Results
from All Sites
N/A N/A N/A N/A N/A
73
Section 2: Overall Assessment
Risks of Bias
Minimized
Low quality (-) Low quality (-) Acceptable (+) Low quality (-) Low quality (-)
Overall Effect due to
Intervention Alone
Yes Yes Yes Yes Yes
Result Applicable to
Target
Yes Yes Yes Yes Yes
Notes The use of
water-soluble
lubricating gel in the
collection of the
traditional
Papanicolaou smear
did not interfere with
the cervical cytology
results nor did it
make a difference in
the discomfort level
of the patients.
The use of
lubricating gel
decreases the pain
associated with the
insertion, dilation
and extraction of
speculum during the
speculum
examination in
gynecologic
oncology patient.
The use of
lubricating gel
decreases the pain
associated with the
insertion of
speculum without
affecting the
adequacy of
cytology.
The application of a
small amount of
water-based
lubrication decreases
the pain associated
with the insertion
and opening of
speculum in both
premenopausal and
postmenopausal
women without
affecting the
cytology result.
The use of a small
amount of
water-soluble
lubricating gel
decreases the pain
associated with the
insertion of
speculum without
obscuring the
cytological
interpretation of both
conventional
cytology and
liquid-based
cytology.
Level of Evidence 1+ 1+ 1++ 1+ 1+
IG = Intervention Group
CG = Control Group
N/A = not Available
74
Appendix F
Gantt Chart Illustrating the Time Schedule for the Implementation Process of the
Proposed Innovation
Month
Task
1 2 3 4 5 6 7 8 9
Preparation of Proposal
& Guideline
Approval of Proposal by
the Administrative Level
of DH
Staff Training &
Preparation of
Equipment
Formal Implementation
of the Proposed
Innovation
Data Analysis &
Evaluation
75
Appendix G - Service timetable at designated MCHC
Number of long week in 2015 = 24
Number of short week in 2015 = 28
Number of cervical screening sessions per year = (24 x 4) + (28 x 3) = 180 sessions
Number of cervical screening sessions per three months = 180/4 = 45 sessions
Max number of cervical screening test to be performed in 2015
= (17+15+17+13) x 24 + (17+15+17) x 28
= (62 x 24) + (49 x 28)
= 1488 + 1372
= 2860 tests
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
9am to
1pm
Child
Health Cervical
Screening
(15 quota)
Child
Health
Antenatel Child
Health
Child
Health &
Cervical
Screening
(13 quota)
/
2pm to
5:30pm
Cervical
Screening
(17 quota)
Child
Health
Child
Health
Child
Health Cervical
Screening
(17 quota)
/ /
76
Appendix H - Budget Plan
Item Estimated cost (HKD $) per three months
Innovation Existing practice Reduction
Cost of lubrication $15* x (45 sessions/ 3)**
= $225
$3*** x 4packs**** x 45
sessions = $540
-58.33%
Photocopy of
Guideline (2 pages)
including pictures
(1 page) for staff
reference
$0.3 x 3 pages x 20^
= $18
$0 +18%
Photocopy of
questionnaire for
client evaluation
$0.3 x 60 tests^^
= $18
$0 +18%
Photocopy of
questionnaire for
evaluation of all
medical staff
$0.3 x 17 staff
= $5.1
$0 +5.1%
Photocopy of
questionnaire for
evaluation of
Smear Taker
$0.3 x 13 Smear Takers
= $3.9
$0 +3.9%
Training for new
staff to be a smear
taker
No extra cost as the
innovation can be
integrated with the original
training schedule
$0 0%
Skills review for
existing smear
taker
No extra cost as the skills
reviewing session can be
completed during weekly
in-service meeting
$0 0%
Total $270 $540 -50%
*KY-Jelly: $15/tube
**One tube of KY-Jelly can be used for approximately 3 sessions if the quota are all fully
booked.
***Normal Saline: $3 per pack
****4 packs of NS are needed for each session
^There is a total of 17 medical staff in the designated MCHC. 3 sets of photo will be provided
in the smear taking room for easy referencing. Therefore, 20 sets of guideline are needed.
^^ With the consideration from sample size calculation for the pilot study, the final expected
sample size is 60.
77
Appendix I
Evidence-based Practice (EBP) Guideline
Title
An Evidence-based Practice (EBP) Guideline for applying water-based lubricant (KY-Jelly) to
reduce pain for women undergoing cervical screening (CS) in the Maternal and Child Health
Centre
Aim
To alleviate the pain and distress in women undergoing CS in the MCHC
Objectives
To summarize the research evidence for the use of lubrication during the procedure of CS
To formulate recommendations on relief of speculum examination induced pain based on
the research evidence
To formulate clinical practice instructions for the Cervical Screening Programme (CSP) in
MCHC
To streamline and standardize the CS process
Intended Users
The guideline is intended for use by all nursing staff responsible for performing CS in the
designated MCHC.
Intended Target Group
Women aged 25 to 64 who ever had sex and without performing total hysterectomy visiting the
MCHC for CS will be the intended target group for this guideline.
78
Recommendations
Recommendation 1:
Application of water-based gel lubricant to the vaginal speculum during the process of CS can
decrease the pain associated
Available Evidence:
a) During the insertion, dilation and extraction phase, the mean VAS score reported was
significantly lower in the lubricant gel group compared with the water group. (Gungorduk
et al., 2014) (1+)
b) The use of gel lubrication significantly decreased VAS pain scores during speculum
examination. (Gungorduk et al., 2014) (1+)
c) Placing gel between the plastic blades of the speculum and the vaginal walls decreases
friction, which is theorized would lead to less pain compared with using water alone as
lubricant. (Hill & Lamvu, 2012) (1++)
d) The use of water-based gel lubricant on the vaginal speculum provides pain relief during
Pap smear examination in both premenopausal and postmenopausal women. (Simavli et
al., 2014) (1+)
[Grade of Recommendation: A]
79
Recommendation 2:
Water-based lubrication does not interfere with the cytological interpretation.
Available Evidence:
a) No unsatisfactory result was noted in both lubricant gel and water group who underwent
screening using liquid cytology. It showed that gel lubrication does not alter the
cytological interpretation of cervical specimens. It is a conscientious step in female health
care and is safe for cytological evaluation of cervix.(Gungorduk et al., 2014) (1+)
b) The use of water-based gel lubricant on the outer superior and inferior blade of the vaginal
speculum does not affect the rate of unsatisfactory results of the smear test, consistent
with most of the previous studies. (Simavli et al, 2014) (1+)
c) During the collection of Papanicolaou test specimens, lubricate the speculum with a small
amount of KY-Jelly reduces the pain associated with insertion of the vaginal speculum
without obscuring the cytological interpretation of conventional cytology or liquid-based
cytology. (Uyger et al, 2012) (1+)
d) No unsatisfactory result was noted in both lubricant gel and water group reassured that
that gel lubricants would not affect Pap test adequency. (Hill & Lamvu, 2012) (1++)
e) Gel lubrication does not affect the results of the Papanicolaou smear. (Gilson et al., 2006)
(1+)
[Grade of Recommendation: A]
80
Recommendation 3:
Water-based lubrication without containing of “carbomers” or “carbopol polymers” would not
interfere with the interpretation of liquid-based cytology.
Available Evidence:
One manufacturer of liquid-based cytology recommends avoiding lubricants containing
“cabomers” or “carbopol polymers”, which may interfere with liquid-based Pap tests. (Hill &
Lamvu, 2012)(1++) (Gungorduk et al., 2014) (1+)
[Grade of Recommendation: B]
Recommendation 4:
Pain is considered as a barrier to cervical cytology.
Available Evidence:
a) Some patients may be afraid to have speculum examinations as a result of concern about
pain, which is a barrier to cervical cytology and sexually transmitted infection testing.
(Hill & Lamvu, 2012) (1++)
b) The worry of pain with the pelvic examination was found as a very common reason for
women especially adolescents not to present for initial or follow-up cervical cytology.
(Simavli et al., 2014) (1+)
c) Fear of pain during a vaginal examination may reduce the compliance of some women
with regular screening. (Uyger et al, 2012) (1+)
[Grade of Recommendation: A]
81
Appendix J
Grades of Recommendations
Grade Statements
A
At least one meta-analysis, systematic review, or RCT rated as 1++, and
directly applicable to the target population; 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+
(SIGN, 2011)
82
Appendix K – Photo Demonstration on the Application of KY-Jelly
83
Appendix L – Questionnaire for all Medical Staff
Please put a tick() in the appropriate boxes below to indicate your views on the following
statements:
Strongly
Disagree
Disagree Neutral Agree
Strongly
Agree
1. The EBP guideline is user-friendly and easy to
understand.
2. The photo demonstrating the application of
KY-Jelly is useful.
3. Training on refining the skills of KY-Jelly
application is adequate.
4. I understand the logistics of the implementation.
5. With the EBP guideline and training provided, I
am competent in implementing the proposed
innovation.
Other comment and recommendations:
84
Appendix M – Satisfaction and Self-reflected Competence Questionnaire for Smear
Taker
Please put a tick() in the appropriate boxes below to indicate your views on the following
statements:
Strongly
Disagree
Disagree Neutral Agree
Strongly
Agree
1. Equipment is adequate and readily available
during the implementation period of the
innovation
2. The logistics is smooth.
3. Workload is acceptable after the launch of the
proposed innovation
4. Time spent for performing cervical screening
for a single client is reasonable.
5. The proposed innovation successfully helps me
to increase my competence in performing
cervical screening.
6. Overall, I am satisfied with the innovation
Other comment and recommendations:
85
Appendix N – Satisfaction Questionnaire for Participant
Part A: Please rate your pain level according.
Part B: Please put a tick() in the appropriate boxes below to indicate your views on the
following statements:
Strongly
Disagree
Disagree Neutral Agree
Strongly
Agree
1. It is less painful than the previous experience.
(*No need to answer if it‟s your first
experience.)
2. I am confident in the nursing staff who
delivered the cervical screening service today.
3. Overall, I am satisfied with the screening today.
4. I will adhere to the suggested schedule and
return for screening again.
Other comment and recommendations:
1
Insertion
2
Dilation
3
Extraction
The worst pain
imaginable
10
No Pain
0 1 2 3 4 5 6 7 8 9
86
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