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
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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
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.