i

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.

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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.

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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.

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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.

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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.

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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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