1 Abstract of dissertation entitled “An evidenced-based guideline on cold application prior to the removal of chest tubes to reduce pain in cardiothoracic surgical patients” Submitted by Yim Tin Chee For the degree of Master of Nursing at the University of Hong Kong in July 2015 Chest tubes are commonly inserted during cardiothoracic surgery (CTS) in order to drain air and fluid out from the pleural cavity. Chest tube removal (CTR) will be performed by the physician if the drainage amount is adequate. Nevertheless, CTS patients have reported unpleasant painful experiences during CTR. They are highly susceptible to postoperative complications and thus delay their recovery processes and increase the medical costs for these uncontrolled pains. Both CTS patients and the medical institution can share the benefits if an effective and evidence based intervention can be introduced. The aims of this dissertation are to evaluate the current evidences of applying cold application prior to CTR to reduce pain in CTS patients, to develop a standardized and evidence based protocol for nurses by using pharmacological and non-pharmacological methods to manage pain suffered by CTS patients during CTR,
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1
Abstract of dissertation entitled
“An evidenced-based guideline on cold application prior to the removal of chest
tubes to reduce pain in cardiothoracic surgical patients”
Submitted by
Yim Tin Chee
For the degree of Master of Nursing at the University of Hong Kong
in July 2015
Chest tubes are commonly inserted during cardiothoracic surgery (CTS) in order
to drain air and fluid out from the pleural cavity. Chest tube removal (CTR) will be
performed by the physician if the drainage amount is adequate. Nevertheless, CTS
patients have reported unpleasant painful experiences during CTR. They are highly
susceptible to postoperative complications and thus delay their recovery processes and
increase the medical costs for these uncontrolled pains. Both CTS patients and the
medical institution can share the benefits if an effective and evidence based
intervention can be introduced.
The aims of this dissertation are to evaluate the current evidences of applying
cold application prior to CTR to reduce pain in CTS patients, to develop a
standardized and evidence based protocol for nurses by using pharmacological and
non-pharmacological methods to manage pain suffered by CTS patients during CTR,
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to assess its transferability and feasibility and discuss the implementation designs in
CTS units in Hong Kong. Finally, an evaluation plan will be developed to evaluate the
clinical outcomes.
There were seven articles included which related to the use of cold application to
relieve pain for CTS patients during CTR. Checklist designed by the Scottish
Intercollegiate Guidelines Network (SIGN) was used to evaluate the methodological
quality of the selected articles. Six articles were rated as acceptable in methodological
quality which successfully demonstrated better pain relieving effect in cold
application group when compared with control group immediately and certain period
after CTR.
A nurse driven evidence based guideline has been created after literature review.
The implementation potential of the guideline in local CTS units has been examined.
A working group consists of administrators, experienced and frontline staffs will be
responsible to guide the programme implementation. Feedbacks for the guideline are
collected via communication between the group members and other frontline staffs.
The feasibility of the programme will be determined based on the results of the pilot
study. The patient’s outcomes, healthcare provider outcomes and system outcomes
will be monitored by the working group annually to determine the worthiness of the
programme.
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An evidenced-based guideline on cold application prior to the
removal of chest tubes to reduce pain in cardiothoracic surgical
patients
by
Yim Tin Chee
BN, RN
A thesis submitted in partial fulfillment of the requirements for the Degree of
Master of Nursing at the University of Hong Kong.
July 2015
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Declaration
I declare that this thesis 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: Yim Tin Chee
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Acknowledgements
I would like to express my sincere gratitude to my dissertation supervisor, Dr
Janet Wong (Assistant Professor), who has provided invaluable guidance,
encouragement and expert opinions throughout the 2 years dissertation preparations.
Beside, I would also like to thank my dear classmates of the Master of Nursing
programme (2015) and hospital colleagues, who have supported and given me
encouragement throughout the study.
Finally, I would like to express my deepest gratitude to my family for their
greatest support during my 2 years study. Without their support, I cannot concentrate
to complete these 2 years study.
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Content Page
Dissertation abstract P.1
Declaration P.4
Acknowledgements P.5
Chapter 1: Introduction
1.1: Background of the study issue P.10
1.2: Affirming need of the study issue P.11
1.3: Objectives and significance P.13
Chapter 2: Critical appraisal
2.1: Search and appraisal strategies
2.1.1: Databases searching P.15
2.1.2: Inclusion and exclusion criteria P.15
2.1.3: Data extraction P.15
2.1.4: Appraisal strategies P.16
2.2: Results
2.2.1: Date of search and search history P.17
2.2.2: Study characteristics P.17
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2.2.3: Methodological Quality P.18
2.3: Summary and synthesis
2.3.1: Summary of results P.21
2.3.2: Synthesis of results P.24
2.3.3: Conclusion P.29
Chapter 3: Implementation potential and clinical guideline
3.1: Transferability of findings
3.1.1: Target setting and population P.31
3.1.2: Similarities and differences between local and literature settings P.32
3.1.3: Philosophy of care P.32
3.1.4: Periods for implementation and evaluation P.33
3.2: Feasibility of findings
3.2.1: Manpower and attitudes of the nurses P.33
3.2.2: Training sessions and environment P.34
3.2.3: Multi-discipline co-operations P.35
3.2.4: Tools for evaluation P.36
3.3: Costs and Benefits
3.3.1: Individual benefits and risks P.37
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3.3.2: Material costs of the institution P.39
3.3.3: Non-material costs of the institution P.40
3.4: Evidence-based practice guideline
3.4.1: Guideline title P.41
3.4.2: Objectives P.41
3.4.3: Target populations P.42
3.4.4: Evidence based recommendations P.42
Chapter 4: Implementation plan
4.1: Communication plan--- An overview
4.1.1: Stakeholders identification P.44
4.1.2: Forming a working group P.45
4.1.3: Roles of working group P.46
4.2: Pilot study plan
4.2.1: Patient’s recruitment P.49
4.2.2: Rundown testing P.49
4.2.3: Pilot study evaluations P.50
4.3: Evaluation plan
4.3.1: Patient outcomes P.51
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4.3.2: Healthcare provider outcomes P.52
4.3.3: Systems outcomes P.52
4.3.4: Data measurements and analysis P.53
4.3.4.1: Patients outcomes P.53
4.3.4.2: Healthcare provider outcomes P.55
4.3.4.3: System outcomes P.55
4.4: Basis for implementation P.55
Conclusion P.56
References P.56
Appendices P.62
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Chapter 1: Introduction
1.1: Background of the study issue
Chest tubes are commonly inserted during cardiothoracic surgeries (CTS), such
as coronary artery bypass grafting with or without heart valves repair and lobectomy
(Mitra, Nahid, Nouraddin & Eskandar, 2014; Sauls, 2002), in order to drain air and
fluid out from the pleural cavity (Demir & Khorsbid, 2010; Ertug & Ulker, 2011).
Chest tubes will be removed by the physicians when the drainage amount is adequate
application in combination with indomethacin suppository on chest tube removal pain
in patients undergoing open heart surgery. Iranian Journal of Nursing and Midwifery
Research, 19(1), 77-81.
29: New Territories West Cluster. (2014). EIS Daily Reporting Form in Tuen Mun
Hospital. Hong Kong: Hospital Authority.
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Appendix 1: Search history (PRISMA Flow Diagram)
Identification
Literatures identified through database searching
(n = 13)
Additional literatures identified through other sources
(n = 1)
Literatures after duplicates removed (n = 7)
Screening
Literatures screened (n = 7)
Literatures excluded (n = 0)
Eligibility
Full-text articles assessed for eligibility
(n = 7)
Full-text articles excluded, with reasons
(n = 0) Included
Studies included in qualitative synthesis
(n = 0)
Studies included in quantitative synthesis
(meta-analysis) (n = 7)
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Appendix 2: Table of evidence Bibliographic citation
Study type
Patient characteristics
Intervention(s) Comparison Length of FU
Outcome measures Effect size Mean(IG – CG)
Sauls, 2002
RCT
study
-Cardiac patients in 2 ICU
and 3 postoperative units
with chest tubes inserted
-Ages: 21-85 years old
(Mean ages: 59.7 years
old)
Ice pack was applied to the
skin at either side of the chest
tubes, covering 38.7 cm² for
10 minutes
(n=25)
Tap water pack (30.6°C to
31.7°C) was applied to the
skin at either side of the chest
tubes, covering 38.7 cm² for
10 minutes
(n=25)
Not
mentioned
Primary:
(1) Pain & Distress in NRS:
(A) immediately after CTR
(B)10 minutes after CTR
(2) No. of quality descriptors
for pain
Secondary:
(3) Pain & Distress in NRS
10mins after packs application
(1) (A):
Pain: -0.48 (p>0.05)
Distress: +0.42 (p>0.05)
(1) (B):
Pain: -0.26 (p>0.05)
Distress: -0.1 (p>0.05)
(2) Both groups: 15
(3)Pain: +0.14 (p>0.05)
Distress: -0.1 (p>0.05)
Demir, 2010 RCT
study
-Cardiac patients in ICU
with 2-3 chest tubes
inserted
-Ages: 18-74 years old
(Mean ages: 53.4 years
old), BMI<30kg/m²
-10mg/kg paracetamol IV
was injected 60 minutes
before CTR (for all groups)
- A gel pack (+4°C) was
placed to the skin occupying
5cm³ surrounding chest tubes
for 20 minutes
(n=30)
Two comparison groups
(a) & (b):
(a) A gel pack (room
temperature) was placed to
the skin occupy 5cm³
surrounding chest tubes for
20 minutes (n=30)
(b) Nil packs being applied
(n=30)
Not
mentioned
Primary:
(1) Pain in VAS:
(A) immediately after CTR
(B) 15 minutes after CTR
(2) Anxiety score difference
(STAI-I) 15 minutes after CTR
Secondary:
(3) length of time (hours)
before requesting analgesics
after CTR
(1)(A)(a): -0.36 (in sig.)
(1)(A)(b): -0.46 (in sig.)
(1)(B)(a): -0.7 (in sig.)
(1)(B)(b): -0.7 (in sig.)
(2)(a): -3.21 (p>0.05)
(2)(b): -4.4 (p>0.05)
(3)(a): +0.3 (p<0.05)
(3)(b): +0.43 (p<0.05)
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Bibliographic citation
Study type
Patient characteristics
Intervention(s) Comparison Length of FU
Outcome measures Effect size Mean(IG – CG)
Ertug, 2011
CT
study
-Thoracic surgery patients
in postoperative surgical
clinic with 1 chest tube
inserted
-Did not have CTR
experience
-Ages:18-65 years old
(Mean ages: 48.7 years
old)
-Ice pack covered 6.125 cm²
skin around the chest tube
before CTR
-Pack removed when reached
13°C (average time: 9 mins)
(n=70)
No ice pack application
before CTR
(n=70)
Not
mentioned
Primary:
(1) Pain in VAS:
(A) immediately after CTR
(B) 5 minutes after CTR
Secondary:
(2) 4 time points temperature
around the skin of the chest
tube in intervention group
(1)(A) -1.75 (p<0.05)
(1)(B) -0.38 (p<0.05)
(2)
1st data: 33.13°C
2nd data: 12.93°C
3rd data: 23.58°C
4th data: 29.59°C
(p<0.05)
Mazloum, 2012 RCT
study
-Cardiac patients in ICU
with 1 pericardial and 1
thoracic chest tube.
-Distance between the
tubes: 8-10cm.
-Mean ages: 56 years old.
Mean BMI: 25kg/m²
-Midazolam IV was given (for
all groups)
-Ice packs (0 -5°C) were bent
in half circle shape and being
applied around the skin of the
chest tube for 20 minutes
(n=34)
Comparison groups (a)&(b):
(a) Placebo packs
(18-22°C) were bent in half
circle shape and being
applied around the skin of the
chest tube for 20 minutes
(n=34)
(b) Nil packs being applied
(n=34)
Not
mentioned
Primary:
Pain in VAS:
(A) immediately after CTR
(B) 15 minutes after CTR
(A)(a) -1.7 (p<0.05)
(A)(b) -1.5 (p<0.05)
(B)(a) -1.4 (p<0.05)
(B)(b) -1.3 (p<0.05)
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Bibliographic citation
Study type
Patient characteristics Intervention(s) Comparison Length of FU
Outcome measures Effect size Mean(IG – CG)
Otaibi, 2013 RCT
study
-CTS patients in surgical ward
and ICU with 1 or 2
mediastinal or pleural chest
tubes.
-Mean ages: 40.7 years old
-1gram perfalgan received 60
minutes before CTR (for all
groups)
-A soft ice gel pack was placed
around the skin of the chest
tube
-Gel pack removed when
reached 13°C
(n=20)
Placebo pack (room
temperature) being
applied (n=20)
Not
mentioned
Primary:
(A) Pain in VAS:
(B) Immediately after CTR
(C) 15 minutes after CTR
(2) HAM-A changes after CTR
Secondary:
(3) Correlation: Pre-CTR
anxiety VS pain level
15minutes after CTR
(4) Demographic
characteristics VS pain level
(1)(A) -5.95 (p<0.05)
(1)(B) -1.8 (p<0.05)
(2) -5.55 (in sig.)
(3) +0.0364 (p<0.05)
(4) Pain level:
-before CTR: p<0.05
–during CTR: p>0.05
-15 minutes after CTR:
p>0.05
Gorji, 2014 RCT
study
-Open heart CABG patients in
CCU with 1 left pleural and 1
mediastinal chest tubes
-Did not have CTR experience
-Mean BMI: 25.8kg/m². Mean
ages: 58.1 years old
-Acetaminophen pills received
every 6 hours (for all groups)
-3 cold gel packs (0°C) twisted
by gauze were placed to skin
surrounding chest tubes
-Packs removed when reached
13°C (mean time: 10 minutes)
(n=40)
Nil gel packs being
applied
(n=40)
Not
mentioned
Primary:
Pain in VAS:
(A) immediately after CTR
(B) 15 minutes after CTR
(A) -2.2 (p<0.05)
(B) -0.22 (p<0.05)
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Bibliographic citation
Study type
Patient characteristics Intervention(s) Comparison Length of FU
Outcome measures Effect size Mean(IG – CG)
Mitra, 2014 RCT
study
-CABG or CABG with
valvular surgery patients in
ICU with pleural and
mediastinal chest tubes.
-Mean ages: 58.7 years old
-Indomethacin suppository of
dosage: 100mg received 1
hour before CTR (for all
groups)
-A cold gel pack (4 °C) was
applied to the skin
surrounding chest tube for 20
minutes before CTR
(n=32)
A gel pack (room
temperature) was applied
to the skin surrounding
chest tube for 20 minutes
before CTR
(n=34)
Not
mentioned
Primary:
Pain in VAS:
(A) Immediately after CTR
(B) 15 minutes after CTR
(A) -1.23 (p<0.05)
(B) -0.14 (p>0.05)
Abbreviations: 1: CTR= chest tube removal 6: in sig.= in significant 2: Length of FU= length of follow up, in months 7: RCT= randomised controlled trial 3: IG – CG= intervention group – comparison group 8: CCT= clinical controlled trial 4: NRS & VAS= numerical rating scale & visual analogue scale 9: HAM-A= Hamilton anxiety rating Both scales ranged from 0 to 10 scores, with 0 = the least severe, 10 =the most severe scale 5: STAI-I= Spielberger situational anxiety level inventory 10: CTS= cardiothoracic surgery (Larger negative value= more reduction in anxiety level)
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Appendix 3: Methodology checklist (Based on SIGN checklist related to controlled trials)
Sauls, 2002 article: 1: Internal Validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. As mentioned in the article, the participants were those aged from 21-85 years old with chest tubes inserted after cardiac surgery. In the intervention group, ice pack was placed at either side of the chest tube’s skin for 10 minutes before CTR. The comparison group was the application of tap water pack for 10 minutes before CTR. The primary outcomes of the study were the pain level and pain distress immediately and 10 minutes after CTR. The number of quality descriptors used for pain after CTR was another primary outcome. The secondary outcomes of this study were the pain and distress level 10 minutes after the application of packs before CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Can’t say. The Author only stated that the participants were randomly assigned into intervention and control groups, but did not mention the randomization method in details. 1.3: An adequate concealment method is used. Answer: No. There was no mention for the concealment methods for the researchers when assigning participants into groups. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Can’t say. As the presence of blinding for patients and investigators were not clearly mentioned.
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1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The author stated that the demographic data of the participants such as the age, gender, ethnicity, primary diagnosis, type and number of chest tubes, previous cardiac surgery and previous chest tubes experience and type of postoperative pain medication were collected and mentioned that there were no significant differences between the intervention and comparison groups. However, the actual data for these demographic variables had not been listed in the article. 1.6: The only difference between groups is the treatment under investigation. Answer: No. As mentioned by the author, the investigator, which was the only nurse present during the intervention, might provided a chance for some of the participants to ask questions related to the treatment received. It was difficult for the investigator not to respond to their questions and extra information and explanations were provided by the investigator to some of the participants. Also, seven health care professionals with different level of expertise performed the CTR, the environmental nature of different sites might create extraneous variables for the participants. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The conclusion of this article based on primary outcomes. The primary outcomes of the study were to see whether the application of ice pack around the chest tubes for 10 minutes can significantly decreased the pain level and pain distress of the patients immediately and 10 minutes after CTR. Another primary outcome was to see whether fewer quality descriptors for pain would be used in the intervention group than the comparison group after CTR. The measurement tool for pain level and pain distress was numeric rating scale (NRS), which was supported by Puntillo (1994, 1996) & Puntillo & Weiss (1994), to effectively rate the procedural pain and distress of critically ill patients. The presence of reliability and construct validity for this NRS had also been supported by Downie et al. (1978), Jensen, Karoly & Braver (1986), Jensen, Karoly, O’Riordan, Bland & Burns (1989). The quality descriptors for pain listed in the McGill Pain Questionnaire-Short Form (MPQ-SF) were used. The presence of reliability and validity for MPQ-SF had been supported by Chapman et al. (1985), Wilke, Savedra, Holzemer, Tesler & Paul (1990).
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1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: No participants dropped out from both intervention and control groups after being recruited. 1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable as all the participants in both intervention and control groups completed the treatments assigned to them. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Can’t say. As the study carried out at different units (a surgical intensive care unit, a coronary intensive care unit, a medical intensive care unit and 2 acute postoperative units) in a teaching hospital, there were no reports given for the specific data of these sites. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: The quality of the study was rated unacceptable (reject 0). The main problem for this study was that the difference between the intervention and control groups was not only the treatments, but also the extra explanations and information provided by the investigator which might create some extraneous variables to the results. 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? Answer: It is not certain that the overall effect was due to the intervention. According to the results, there were no significant difference between the intervention and the control groups in pain level, distress level and the number of quality descriptors used for pain. From the methodological
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aspect, the randomization method, the concealment method, the blinding method and the results for the specific site should be elaborated and reported in details. The major confounding variables should be the treatments offered to both the intervention and control groups. The inconsistency of the environment for different sites, the different expertise level of health care professionals in performing CTR and the extra information and explanations provided by the investigator for some of the participants might affected the final results. For the statistical power of the sample, there was nil information being mentioned. However, in view of 25 participants for both groups yielded non-significant difference results, sample size should be increased for future study to improve the statistical power. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: The study intervention can be directly applied to the patients, as cold application method is cheap, safe to patients and easy to be applied. However, in view of the insignificant difference results between the intervention and control groups, it may not be considered by the health care professionals to implement this intervention. 2.4: Conclusion and comment for this article: According to the Author, pain consisted of distress component (affective) and sensory pain and they are correlated. Similar study should be done in the future, in which the ice pack application could be longer than 10 minutes to produce a desire effect, a larger sample sized is needed, dividing participants into 3 groups which contained intervention group, placebo group and those undergo usual treatment to rule out whether there were any effects for the placebo treatment. In the article, the tap water at the range of 30.6°C to 31.7°C might achieve some kind of cooling effect to the skin temperature in the control group, which might contribute to the non-significant difference results between the intervention and control groups. Furthermore, an effort to control extraneous variables, better randomization, concealment and blinding methods should be elaborated clearly in the future study to improve generalizability.
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Demir, 2010 article: 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. The targeted patients in this study were those cardiac surgery patients aged 18-74 years old, BMI<30kg/m² and with 2 to 3 chest tubes inserted after operations in ICU. A standard dose of 10mg/kg paracetamol IV would be injected to all participants 60 minutes before CTR. For the intervention group, a cold gel pack (+4°C) wrapped with gauze would be bent and placed to the surrounding skin of chest tubes for 20 minutes before CTR. There were two comparison groups, the placebo and control groups. For the placebo group, a gel pack at room temperature wrapped with gauze would be bent and placed to the surrounding skin of chest tubes for 20 minutes before CTR. For the control group, nil gel pack would be applied. The primary outcomes of the study were pain intensity immediately and 15 minutes after CTR and anxiety level during CTR. The secondary outcome would be the length of time before the request for analgesics after CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Can’t say. The authors only stated that a simple randomization method was used for assigning participants into groups. However, there was no mention about the randomization method in details. 1.3: An adequate concealment method is used. Answer: Can’t say. The authors only mentioned that some methods were used to prevent manipulation during assignment. However, no details about the methods were provided.
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1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. As mentioned by the authors, the study participants were ‘blinded’ by the researcher and did not know which groups they were in. 1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The authors only stated that the demographic and clinical features of the participants in the three groups were similar and no significant differences, with P>0.05. A table listing the demographic and clinical features of the participants in each group should be provided for better understanding. 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. The participants in each group received their treatments in standard way according to the group being assigned. All the chest tubes were removed by the same doctor. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The first primary outcome of this study was to determine whether the application of cold gel pack could significantly reduce the pain intensity immediately and 15 minutes after CTR. Another outcome was to determine whether the intervention could significantly reduce the anxiety level during CTR. The conclusions of this study based on the primary outcomes. The pain intensity was rated by vertical visual analog scale (VAS). The validity of VAS was supported by Puntillo (1994) for critically ill cardiovascular surgery patients. The anxiety level was measured by a tool called Spielberger Situational Anxiety level Inventory (STAI-I), the concurrent validity was supported by LaCompte & Oner (1976).
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1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: No participants dropped out after being recruited. 1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable. The participants in the groups received their treatments according to the groups being assigned. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Not applicable as the study only conducted at the cardiovascular and thoracic surgical intensive care unit at Ege University Hospital. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: The quality of the study was rated acceptable (+). Most of the internal validity criteria are met for this study. Single blinding method was used and the treatments received by the participants were standard according to the group being assigned. However, the randomization and concealment methods should be elaborated more for better understanding. 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? Answer: It is quite certain that the overall effect is due to the intervention, but improvements should be considered. The intervention group had shown a significant reduction in pain intensity immediately and 15 minutes after CTR. In addition, it showed longer time for requesting analgesics after CTR when compared with the comparison groups. When viewing the methodology used for this study, according to Sauls (2002)
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study, the use of 30.6°C to 31.7°C placebo bag to the group might actually provide a cooling effect to the skin of the placebo group. The placebo pack used in this study was at room temperature, which might reduce the cooling effect to the placebo group. In addition, single blinded method applied to the participants could reduce the bias arise in the study. Furthermore, the demographic data for both intervention and comparison groups were similar (P>0.05), each participant received treatments according to the group being assigned in a standard way increased the rigor of the study results. The tools for measurement were reliable and valid. Only 1 doctor performed CTR also ensured the reliability of the results. However, the authors should elaborate more about the randomization and concealment methods in order to have a better understanding of the study. For the statistical power, power analysis was performed to calculate the simple size, and the power was 81% (alpha <0.05) for the sample size which was adequate to show the effects of the intervention. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: Yes. The application of cold gel pack is simple, safe to patients and cheap which can be directly applied to the patients. It is worth for health care professionals to apply the intervention as this study had shown a significant reduction of pain intensity after CTR. 2.4: Conclusion and comment for this article: According to the study, the cold gel application could significantly reduce the pain intensity during CTR and prolong the time for requesting analgesics, but did not affect the anxiety level being felt by the participants. Participants’ emotions could be affected by the environment, such as the light, noise and the surrounding health care professionals. Furthermore, participants with different cultural backgrounds might affect their perceptions to pain and anxiety. Therefore, environmental factors should be well controlled by the researchers and the culture factor of the participants on pain and anxiety perception should be studied in the future research. Besides, placebo pack of temperature closed to the skin temperature of the participants should be used in order to reduce the cooling effect on the participants in the placebo group. Finally, although the cold gel application group showed a significant decrease in pain intensity during CTR, the VAS was still 6.77 immediately after CTR, which was moderate level in pain. Future studies should be consider to combine cold application method with other pharmacological methods or
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non-pharmacological methods in order to help participants have a better pain control during CTR. Ertug, 2011 article 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. The authors had stated the characteristics of the participants: 18-65 years old with one chest tube and did not have previous CTR experience. Intervention group: ice pack being applied around the chest tube insertion site before CTR until the skin temperature reached 13°C. Comparison group: no ice pack application before CTR. The primary outcomes: the VAS score immediately and 5 minutes after CTR and the secondary outcome: the changes in skin temperature at 4 different time points for the intervention group. 1.2: The assignment of subjects to treatment groups is randomized. Answer: No. The participants were assigned to the intervention and control groups according to the time they were recruited. The participants recruited on the odd-dated days of the month would be arranged to intervention group while those recruited on the even-dated days would be arranged to control group. This study was a clinical controlled trial study instead of randomized controlled trial study. 1.3: An adequate concealment method is used. Answer: Not relevant as it was a clinical controlled trial study. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Not relevant as it was a clinical controlled trial study.
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1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The authors had mentioned the demographic data between the intervention and the control groups. The data included genders (P>0.05), ages (P> 0.05), indications for chest tube insertion (P>0.05) and chest tube insertion days (P< 0.05). Among all the data, only the chest tube insertion days had shown a significant difference but not others. 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. The authors had mentioned that all the participants in the intervention group received the ice pack application while all the participants in the control group received nil treatment. Although different physicians were responsible for CTR for the participants, all the physicians followed the same guideline in performing CTR. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The primary outcomes were the pain score immediately and 5 minutes after CTR. The main conclusion was based on the primary outcomes. The primary outcomes (changes in patients’ pain level) were measured using the vertical VAS. According to Guzeldemir (1995) & Eti-Aslan (2002), VAS was a sensitive and reliable tools for reflecting pain score. In addition, Cline et al. (1992) & Guzeldemir (1995) pointed out that a vertical line based VAS was easily understood by the participants. 1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: The authors had mentioned that there were 5 participants in the intervention group and 4 participants in the control group dropped out from the study before the research began. The drop out rate was 7.14% for the intervention group and 5.71% for the control group and such loss was replaced by recruiting other participants. However, there were no reasons provided for the drop out.
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1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable. It was because all the participants in the intervention group had ice pack application before CTR and the participants in the control group had nil interventions before CTR. The chest tubes in both the intervention and control groups were removed finally. No missing values or dropped out participants noticed after the research began. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Does not apply. It was because the study was carried out in a surgery clinic in a thoracic hospital but not conducted in various sites. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: It was acceptable (+) in general speaking. The study met most of the criteria in the checklist. However, it could not be regarded as a randomized controlled trial study as the assignment of the participants to the groups based on time of recruitment but not randomization. 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? Answer: It was quite certain that the primary outcomes of the study were due to cold application, but some improvements should be considered. In view of the methodology, the pain level of the participants was measured by using VAS, which was reliable and valid as discussed before. All participants received the intervention based on their group and had CTR according to standard protocol. There was no missing data found during the study. However, the assignment of the participants should be randomized instead of determined by the time they were recruited to reduce the demographic bias of the participants between the intervention and the control groups. Lucky, the demographic data between two groups were similar except the days for chest tube insertion. In view of the statistical power of the study, the sample size 140 was adequate since the power
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was calculated as 99%, which was greater than 0.8, for alpha=0.05, as this study contained 2 independent groups. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: This method was cheap, safe and easy to be applied. Therefore, cold application should be considered applying directly to the target patients. The cold application could significantly reduce the pain intensity of the participants immediately and 5 minutes after CTR in this study, which worth to be considered by the health care professionals. 2.4 Conclusion and comment for this article: According to the study, cold application as a non-pharmacological method applied prior to CTR could reduce the pain level immediately and 5 minutes after CTR. In this study, it supported the study result of Demir & Khorshid (2010), which shown a significant decreased in pain level for cold application group after CTR, but contradict with the study result found in Sauls (2002), which showed that cold application was not effective in reducing pain related to CTR. Moreover, this study only employed those with only 1 chest tube, which could not concluded the pain intensity experienced by those with 2 or more chest tubes. Therefore, further studies with a good randomization and concealment methods, larger sample size and recruited those with 2 or more chest tubes in order to increase the generalizability of the result. Mazloum, 2012 article: 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. As mentioned in the article, the participants were those underwent cardiac surgery with mean ages 56 years old, mean BMI=25kg/m² and had one pericardial and one thoracic chest tubes. Participants in both groups had been prescribed midazolam IV before CTR.
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In the intervention group, ice packs of temperature 0-5°C wrapped by cotton clothes would be applied to the skin area surrounding the chest tube for 20 minutes before CTR. There were 2 comparison groups, which were the placebo and the control groups. In the placebo group, packs of temperature 18-22°C wrapped by cotton clothes would be applied to the skin area surrounding the chest tube for 20 minutes before CTR. For the control group, no packs would be applied before CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Yes. The authors stated that the assignment of participants to the groups was randomized. This was a crossover study in which each chest tube in each patient would be assigned for 1 treatment. There were 3 groups in this study, which were the cold application-control group, the cold application-placebo group and the placebo-control group. 3 cards with codes for these 3 groups would be drawn out by the researchers randomly. For example, if a card coded for cold application-control group was drawn, one chest tube would receive ice pack treatment while the other chest tube would not receive any packs for that participant. 1.3: An adequate concealment method is used. Answer: No. The authors did not state any methods for concealment when assigning participants into groups. There was no mention whether the researchers knew the sequence of the cards which were used for assigning participants into different groups. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. This study was a single blinded study in which the participants were ‘blinded’ and did not notice whether they were assigned into intervention or comparison groups. 1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The authors had stated some of the baseline characteristics among the 3 groups, which were the mean ages (P>0.05), mean BMI
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(P>0.05), baseline body temperatures (P>0.05) and the fatigue scores before the study (P>0.05). All of these data were statistically insignificant. However, more data among the participants should be reported such as the genders of participants in each group, nationality etc. 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. All the participants in each group received the same treatments according to the groups being assigned. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The results of the study based on the primary outcomes, which were the pain level immediately and 15 minutes after CTR. The reliability and validity of the VAS for pain level measurement was confirmed by Gift (1989) & Lee (1991). 1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: Not applicable as there was no participants dropped out before the study completed. 1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable as all the participants in each group completed all the treatments being assigned. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Not applicable as the study only conducted at the ICU in Imanm Reza Hospital of Mashhad but not others.
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2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: This study was rated acceptable (+). It was a randomized, single blinded study in which the study participants did not notice which groups they were in. However, a clear concealment method should be stated related to the assignment of participants into different groups. 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? Answer: It was certain that the study results were due to the cold application applied in the intervention group, but improvements should be considered. The pain levels of the participants in the intervention group immediately and 15 minutes after CTR were significantly lower than those of the placebo and the control groups. In view of the methodology of the study, a randomization method was listed out clearly, single blinded method was used so that the participants did not aware which group they were in and there were no significant differences in demographic data among the three groups before the study. However, the details for concealment method in assigning participants to the three groups were not stated clearly. There was no mention on how to prevent the researchers from knowing the sequence or codes of the cards when drawing them. In addition, more demographic data such as genders of the participants in each group, nationality etc. should be reported to minimize bias. When viewing the statistical power of the sample, no power analysis being mentioned. In this study, 34 chest tubes were allocated in each group, which were larger in sample size when compared with Demir (2010) study, in which the power of the sample in Demir (2010) study was 81%. Therefore, the samples size in this study was adequate to reflect the effect of cold application on pain level during CTR. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: Yes. The results of this study showed that the cold application group had significantly reduced the pain level immediately and 15 minutes after CTR when compared with the placebo and the control groups. The application of ice pack around the skin of the chest tubes sites
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was easy, cheap and safe to the patients. It was worth for the health care professionals to consider applying the cold application method to the targeted patients. 2.4: Conclusion and comment for this article: According to the authors, applying ice packs around the skin of the chest tubes sites were easy, cheap and safe method to reduce pain level of the patients during CTR. This study supported the result of Demir (2010) study but contradicted with Sauls (2002) study. The difference of results for this study when compared with Sauls (2002) might due to the longer cold application time being used. This study was a cross-over design, in which each participant act as both intervention and comparison groups at the same time. The advantage for this design is that since the intervention group and the comparison group are conducted in the same person, the baseline difference can be eliminated. However, the disadvantage for this design is the ‘carry over’ effect. The result of the latter group may be due to the carry over effect of the previous group. Although there was a ‘washing period’, in which the time between the CTR of the two chest tubes was 30 minutes, it was difficult to determine whether 30 minutes was enough to eliminate the effect of the previous treatment on the participant. Therefore, if similar cross-over design study will be conducted in the future, the length of the washing period should be investigated so that the effect of the previous treatment can be eliminated before conducting the latter treatment. Otaibi, 2013 article: 1: Internal Validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. According to the study, the participants were those cardiothoracic surgery patients with 1 or 2 mediastinal or pleural chest tubes inserted, mean ages were 40.7 years old. All the participants would receive 1 gram perfalgan 60 minutes before CTR. In the intervention group, a
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soft ice pack gel would be placed on top of a sterile gauze pad surrounding the skin of the chest tube until the skin temperature reached 13°C. For the comparison group, placebo pack at room temperature was applied. The primary outcomes were the pain level during and 15 minutes after CTR and also the anxiety level after CTR. The secondary outcome were the correlation between pre-CTR anxiety and pain level 15 minutes after CTR and also the correlation between the demographic characteristics of the participants and the pain level before, during and 15 minutes after CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Can’t say. It was because the authors only stated that this study was a randomized study, but did not mention any randomization methods. 1.3: An adequate concealment method is used. Answer: No. As there was no mention about any concealment methods used to prevent researches from knowing the assigning sequence of participants into different groups. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. As mentioned by the authors, it was a single blinded study in which the participants were not known which groups they were in. 1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The authors had listed the demographic and baseline characteristics of the participants before the study, such as the gender of each group (P>0.05), the mean ages of each group (P>0.05), the insertion duration of the chest tubes of each group (P>0.05) and also the pain intensity of each group before CTR (P<0.05). Only the pain intensity before CTR of the two groups showed a significant difference but not other characteristics.
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1.6: The only difference between groups is the treatment under investigation. Answer: Yes. All the participants received the same treatments corresponding to the groups being assigned. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Can’t say. The conclusion of the study was based on the primary outcomes, which were the pain level during and 15 minutes after CTR and also the anxiety level after CTR. The tool used for rating pain level was VAS and the tool used for rating anxiety level was Hamilton Anxiety Scale. No mention about the reliability and validity of the tools being mentioned in the article. 1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: Not applicable as there were no participants from each group dropped out before the study was completed. 1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable as all the participants completed all the treatments corresponding to the group being assigned. 1.10: where the study is carried out at more than one site, results are comparable for all sites. Answer: Can’t say. The study was conducted in the cardiothoracic surgical ward and also the intensive care unit of King Fahd Hospital. However, no specific data was provided for each site.
2: Overall assessment of the study: 2.1: How well was the study done to minimize bias?
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Answer: The quality of this study was rated acceptable (+). Single blinding method was used to the participants which could reduce bias to the treatments being applied. However, a clear randomization and concealment methods in assigning participants to different groups should be stated clearly. 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? Answer: It was quite certain that the results were due to the cold application being applied to the participants in the intervention group, but improvements should be considered. The results showed that the pain level was significantly reduced immediately and 15 minutes after CTR in the intervention group when compared with the placebo group. In addition, the anxiety level of the participants in intervention group was significantly lower than those in control group after CTR. In view of the methodology, randomization was mentioned by the authors in assigning patients into two groups. The demographic and baseline characteristics of the participants were similar between the two groups and all the participants received the treatments corresponding to the groups being assigned which could help reduce bias to the study. However, a clear randomization and concealment method should be clearly stated in assigning participants into different groups. Furthermore, the reliability and the validity of the tools used for rating pain and anxiety level, the VAS and the Hamilton Anxiety Scale respectively, should be assessed before using for measurements. Finally, the pain level before CTR for intervention group was significantly higher than those of the control group. The baseline characteristic of the participants should be similar to reduce bias. In view of the statistical power of the sample, there was no mention about the power of the sample size. However, in view of the previous similar studies, 40 participants were not enough to generalize the results to other similar patients. More participants should be recruited in the future studies.
2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: The results of this study could be directly applied to the target patients. In this study, the pain level was significantly reduced immediately and 15 minutes after CTR in intervention group when compared with placebo group. In addition, the anxiety level was also
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significantly lower in the intervention group than those in the control group after CTR. Therefore, it was worth for the health care professionals to consider applying the cold application method to the targeted patients. Moreover, the soft icepack gel was cheap and safe for applying to patients. 2.4: Conclusion and comment for this article: According to the authors, cold application was effective in reducing pain level immediately and 15 minutes after CTR. It could also reduce the anxiety level of the patients after CTR. In view of the secondary outcomes, the pre-anxiety level of the participants in both groups significantly correlated with the pain level after CTR, which supported the previous thought that the anxiety level might affect the perception of pain. The demographic characteristics of the participants significantly affected the pain level perceived before CTR, but not pain level during and 15 minutes after CTR as shown in this study. This is an interesting point as the targeted patients may have different demographic characteristics such as different ethnicity or religious belief. Some patients may particularly fear to pain while some are not. However, due to the small sample size for this study, the results cannot be effectively generalized to others. Future studies with a greater sample size should be conducted to investigate these effects on pain level being perceived by the patients. Gorji, 2014 article 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question.
Answer: Yes. The study clearly stated the participants, intervention, comparison group and outcomes. The characteristics of participants were those with mean ages 58.1 years old, did not have the experience of CTR before and had 2 chest drains. The study contained 3 groups, which were the cold application, relaxation and control groups. Due to the translational research topic interest, only the results of cold application and
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control groups were considered here. Participants in all groups received oral acetaminophen every 6 hours. In intervnetion group, 3 cold gel packs twisted by gauze of 0°C was placed on the skin surrounding the chest tubes until the skin temperature reached 13°C (average time=10 minutes) as measured by infrared temperature before CTR. For control group, there was no gel pack being applied to the participants. The outcomes were the comparison of VAS scores among the groups immediately and 15 minutes after CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Yes. The author stated that the participants were assigned randomly to the intervention and control groups by using the Excel programme in the computer to generate random number to the participants. For the participants in the intervention group, each of the 2 chest tubes for each participant would have individual assignment. The participants would be divided into 7 bulks with 6 participants in each bulk. 3 cards with codes indicated left pleural cold-mediastinal relaxation treatments while 3 cards with codes indicated left pleural relaxation-mediastinal cold therapy would be randomly selected for the chest tubes. As a result, each of the 2 chest tubes for the patients in the intervention group would receive cold application or relaxation treatment according to the card being drawn. 1.3: An adequate concealment method is used. Answer: Can’t say. The author stated that the assignment of the participants into groups by Excel software in the computer, but did not mention whether the researchers knew the sequence and codes on the cards which were used for allocating chest tubes into different treatments in the intervention group.
1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. The author had stated that this was a single and observer-blinded study. A nurse was trained to record VAS and was responsible for recording the pain level for different groups. The nurse was ‘blinded’ for different treatments applied before CTR.
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1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The author had presented the baseline characteristics of the participants before conducting the study. The characteristics were the age (P>0.05), the body mass index (P>0.05), the chest tubes remaining time after operation (P>0.05), the sex (same number of males and females for both experimental and control groups), the education level (P>0.05), the occupation (P>0.05) and their living geographical positions (P>0.05). All of these characteristics were not significant in difference between the intervention and control groups. In addition, there were no significant difference in pain level between the cold application and control groups before CTR (P>0.05). 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. All the participants received acetaminophen tablets every 6 hours and received the treatments according to the groups being assigned. Also, the chest tubes in different groups were removed by the same nurse and the VAS score in different intervals were also recorded by the same nurse for all groups. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The primary outcomes in this study were the pain level for the participants immediately and 15 minutes after CTR and the conclusion of this study based on the primary outcomes. The pain level of the participants was measured by using VAS. Both the reliability and validity of this tool for rating the pain level of CABG patients were supported by van Valen et al. (2012).
1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before study was completed. Answer: Not applicable as there was no drop out of participants during the study.
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1.9: All subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Does not apply as all the participants had received all the treatments according to the group being assigned. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Does not apply as the study was done in Mazandaran Heart Centre only but not multiple sites. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: The quality of this study was acceptable (+). Most of the criteria listed in the checklist were followed, with a good randomization method and as a single blinded study. However, the concealment methods for assigning patients into different intervention groups were not clearly mentioned. 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? Answer: It was quite certain that the results were related to the cold application applied to the surrounding skin of the chest tubes, but improvements should be considered. The pain levels of the cold application group were significantly lesser than the control group immediately and 15 minutes after CTR. In view of the methodology, it was an observer- blinded, randomized controlled study with a good randomization
method by using Excel programme for assigning participants into interventions and control groups. However, the concealment method was not clearly stated, which might create bias to the results. In addition, for the intervention group, each participant needed to undergo two different treatments for the two chest tubes (Relaxation VS Cold application). The pain level result of the relaxation group might not directly related to the
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relaxation treatment since the cold application was applied to one of the chest tube first before proceeding relaxation treatment to another chest tube (carry over effect). Luckily, the cold application group was the main interest in this translational research but not the relaxation group. The baseline characteristics between the intervention and the control groups were similar, which could reduce the bias towards the results. In view of the statistical power, the power for sample size was 0.99. The sample size for this study was adequate to demonstrate the effect of cold application to pain level of the participants after CTR. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: The result of this study can be directly applicable to the target patients undergoing CTR. In this study, the cold application had shown a significant reduction in pain level immediately and 15 minutes after CTR when compared with the control group. The cold packs used for the cold application group were cheap and not causing harm to patients. Due to these factors, cold application method was worth for the health care professionals to consider by applying to the target patients to relieve their pain. 2.4: Conclusion and comment for this article: The Author stated that the cold application was worth to be considered during CTR in view of the significant reduction in pain level in the intervention group when compared with the control group. The cold packs used in this study could be easily bent and cover the skin surrounding the chest tube, which could provide a better cooling effect to the skin. This may be the reason to explain why the study results different from that of the results in Sauls (2002). However, this study only focused on pleural and mediastinal chest tubes but not other chest tubes. To increase the generalizability of the study results, CTR to different sites of the chest with a bigger sample size should be studied in the future. Moreover, as the relaxation treatment group also shown a significant reduction in pain level immediately and 15 minutes after CTR when compared with the
control group, future studies can consider to investigate the combine effect of relaxation and cold application on pain level during and after CTR.
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Mitra, 2014 article 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. This study clearly stated the target participants: postoperative CABG or CABG with vavular surgery patients with mean ages of 58.7 years old with mediastinal and pleural chest tubes. The study divided into intervention and placebo groups. Participants in both groups will receive 100mg Indomethacin suppository one hour before CTR. In intervention group, a cold gel pack of temperature 4 °C was applied on the skin surrounding the chest tube site for 20 minutes before CTR. In Placebo group, a gel pack of room temperature was applied around the skin of the chest tube site for 20 minutes before CTR. The primary outcomes were pain level in terms of VAS immediately and 15 minutes after CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Can’t say. The authors only stated that the participants were randomly assigned to the intervention and placebo groups, but no clear randomized method being mentioned. 1.3: An adequate concealment method is used. Answer: No. There was no mention about whether the researchers knew the allocation sequence or not. No concealment methods being reported. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. The author had mentioned that this is a single-blinded study in which the participants did not know whether they were in intervention or placebo group throughout the study.
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1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The baseline characteristics between the intervention and control groups were listed in a table such as genders (P>0.05), Ages (P>0.05), length of the chest tubes (P>0.05), weight (P>0.05), BMI (P<0.05), type of surgery (P>0.05), type of analgesic used (P>0.05), Graft number (P>0.05), chest tube diameter (P>0.05), vital sign (P>0.05). Among these data, only the BMI showed a statistical difference between the two groups (P<0.05). 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. All participants received 100mg indomethacin suppository 1 hour before the CTR. The chest tube was removed by the same health care professional for all the participants. The only difference was that the intervention group received the 4 °C cold gel pack for 20 minutes before CTR while those in the placebo group received the gel pack for 20 minutes at room temperature before CTR. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The conclusion of this study was based on its primary outcomes, which were the pain levels of the participants in different groups immediately and 15 minutes after CTR. The outcomes were measured by using VAS. Reliability and content validity were confirmed by the Zanjan University of Medical Sciences health related committee. 1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed. Answer: The author had mentioned that there were 2 participants dropped out in the intervention group. The drop out percentage was 5.88% in the intervention group (Total drop out percentage: 3.03%). These 2 patients withdrew because they had respiratory problems during the study.
1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as an intention to treat analysis).
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Answer: No. There was no mention about using intention to treat analysis in analyzing the 2 dropped out participants in the intervention group. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Does not apply. As the participants were recruited and conducted in the ICU of Alinasab hospital but not other sites. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: It was acceptable (+). It was a single blinded study by blinding the participants so that they were not alert whether they were in the intervention or control group. However, the randomization method and concealment method were not clearly stated in this study. 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? Answer: It was quite certain that the results of the study were due to the application of cold in the intervention group, but improvement of the study needed to be considered. The pain level of the intervention group was significantly lower than those of the placebo group immediately and 15 minutes after CTR. In view of the methodology of the study, randomization was mentioned in assigning participants into different groups. The baseline characteristics for the participants in two groups were similar except BMI. Single blinding method was used to blind the participants so that they were not aware which group they were in. The cold application time was 20 minutes in the intervention group, which provided enough time to cool down the skin to exert the analgesic effect. The only differences between the two groups were only the cold pack and the placebo pack in the intervention and control groups respectively. These measures help reduce biases to the study. However, a clear randomization and concealment methods should be mentioned clearly in assigning participants into different groups. In addition, an intention-to-treat analysis should be done to investigate the effects to the 2 dropped out participants. In view of the statistical power of the study, power of the samples was not mentioned. However, in view of only 68 participants in total, it was not adequate. To demonstrate a medium effect
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size (p<0.05) and a power of 0.8, 128 participants in total should be needed. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: The results could be directly applicable to the target patient group. It was because this study had produced a significant reduction in pain level immediately and 15 minutes after CTR when cold pack was applied before CTR. Cold application was a safe, cheap and easy to be learnt by the health care professionals. It was worth for them to consider applying the cold application method to the patients before CTR to reduce patients’ pain. 2.4: Conclusion and comment for this article: According to the authors in this study, cold application method was worth to be used to the patients before CTR to relieve pain during this procedure. However, the samples for this study were small which might not be enough to demonstrate the true effects of cold application. Also, cultural differences and anxiety level of the participants were not studied in this study, which might affect the perception of pain by the participants. Therefore, future study should include these factors to conclude their effects on pain perception by the participants.
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Appendix 4
Comparisons between patients in local and literatures settings:
Patient characteristics Local setting Literature settings
Age ranges (years old) 20-70 18-85
Main type of CTS
performed
Lobectomy and
pneumoectomy
Lobectomy and CABG
Location of chest tubes Pleural Pleural, mediastinal and
pericardial
Setting in performing
CTR
Postoperative surgical
ward
Postoperative surgical
ward and clinic, ICU and
CCU
Preparations before
CTR
Prescribe analgesics just
before CTR
Prescribe analgesics 1
hour before CTR together
with cold application or
cold application alone
Nationality China United States, Iran,
Turkey and Saudi Arabia
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Appendix 5
Pain chart and VAS
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Visual Analogue Scale (VAS):
Using a vertical line, please mark your current level of pain on the 10 cm line
below. The pain level of the patient is determined by measuring the length from
no pain (0 cm) to the point in which the patient has marked.
No pain Extreme pain
Sources:
Pain chart: New Territories West Cluster (2008). Acute pain assessment chart. Hong
scale and the McGilll pain questionnaire: An overview of psychometric properties.
Physical Therapy Reviews, 10, 123-128.
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Appendix 6
Costs for implementing cold application versus usual practice in local setting per year (assume 240
patients undergoing CTR per year)
Preparation items Set-up costs for new programme
(in HK dollars)
Operational costs for new
programme (in HK dollars)
Costs for usual practice (in HK
dollars)
Trainer costs 900(i) 0 0
Silica gel cold packs 0(ii) 120 0
Refrigerator with digital
thermometer
0(ii) 0 0
Dressing pads 0(ii) 408(iii) 0
Mefix 0(ii) 1200(iii) 0
Hourmeters 0(ii) 100(iii) 100
Poster for guideline 130 0 0
New pain assessment form (iv) 12.5 137.5 0
Additional Nursing manpower 4800(v) 48000(vi) 0
Analgesics used 310(vii) 3414 5760(viii)
Antibiotics used (ix) 2400 26400 40320
Hospitalization costs (x) 4860000 6804000
Total 4948332 (T1) 6850180 (T2)
Benefits = T2-T1 6850180-4948332 = 1901848
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Footnotes:
(i): Assumed the senior physiotherapist invited has 10 years working experience and
with hourly rate = $300.
(ii): These items are already present before implementation of the new programme.
(iii): Assumed 2 additional dressing pads per patient, 1 additional box of mefix per
month and 2 additional hourmeters are needed per year for patients undergoing
CTR.
(iv): Assumed the minimum number of new pain assessment forms = 25 pages per
month and photocopying cost to be $0.5 per page.
(v): Assumed the nurses recruited have average 5 years working experience and with
hourly rate = $200.
(vi): Assumed 1 nurse is needed to spend 1 hour in preparing 1 patient undergoing
CTR.
(vii): Assumed 1 patient will take 2 tablets of panadol every 6 hours for duration of 1
day, each tablet costs around $1.9.
(viii): Assumed 1 patient will take 2 MST continus per day for duration of 1 day,
each tablet costs around $12.
(ix): Assumed average length of stay of each patient receiving new programme is 5
days while those receiving the usual practice is 7 days. IV Augmentin is used as an
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antibiotic after CTS and being injected 3 doses per day, each ampoule costs $8.
(x): Assumed average length of stay of each patient receiving new programme is 5
days while those receiving the usual practice is 7 days. According to Hospital
Authority press releases about service costs of hospitals (2012), the costs for an
in-patient bed is $4050 per day for 1 patient.
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Appendix 7: Level of the statements and grades of recommendations (SIGN, 2012) Level of evidence
Level of evidence Evidence statements 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 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+.
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Appendix 8: Evidence based guideline and recommendations
Guideline title:
Cold application programme in reducing procedural pain due to CTR
Objectives:
The aim of this guideline is to relieve the procedural pain suffered by the CTS
patients during CTR. The guideline can help:
1: pick up appropriate CTS patients who are going to undergo CTR,
2: standardize the pain relief preparations before CTR,
3: serve as a revision material for those new comers who are not familiar CTR pain
control.
Target populations:
This guideline is intended to all the nurses who are going to provide pain relief
preparations for the CTS patients before CTR procedure in a local postoperative
surgical unit. The inclusion and exclusion criteria of the patients are shown below.
Inclusion criteria:
1: Patients with ages 20 or above.
2: Patients oriented to time, place and person.
3: CTS patients with at least one chest tube or above undergoing CTR.
4: Able to understand and rate pain level by using VAS.
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Exclusion criteria:
1: Patients who are having psychiatric diseases or dementia.
2: Patients who are having poor visual acuity or blinded.
3: Patients who are oversensitive to cold and allergic to panadol.
Recommendations grading:
(1): VAS is an appropriate tool for assessing patient’s pain level during CTR. (Grade
of recommendation: B)
Evidence: VAS provides a continuum for patients to rate their pain level and easily
being understood by them. It also showed high reliability and validity in assessing
Modabber et al., 2013(1+); Sarifakioglu & Sarifakioglu, 2004(1+)]
(3): Silica gel cold packs are more effective in providing cooling effect than ice
packs. (Grade of recommendation: A)
Evidence: Silica gel cold packs are more flexible and easier to be bent than ice
packs in order to provide effective cooling around the chest tube. Similar study by
comparing the cooling effect of cold gel packs and ice packs had been conducted in
applying to postoperative episiotomy wound. Patients with cold gel pads being
applied had significant lower pain level when compared those with ice packs being
applied (p=0.003). [Gorji et al., 2014(3); Zahra et al., 2008(1+)]
(4): The duration for cold application and temperature should be 20 minutes and
around 0-5°C in order to provide adequate analgesic effects to the patients. (Grade
of recommendation: A)
Evidence: Adequate cold application time and low temperature of the cold gel packs
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are important to provide effective cooling to patient’s skin and thus the analgesic
effects. In Sauls (2002) study, the cold application time was 10 minutes, which
showed a non-significant result in pain reduction in the intervention group. Studies
later had prolonged the cold application time to 20 minutes or used patient’s skin
temperature as an indicator for cold application time. Significant results were
yielded after this amendment. [Demir & Khorshid, 2010(1+); Ertug & Ulker,
2011(1+); Gorji et al., 2014(1+); Mazloum et al., 2012(1+); Mitra et al., 2014(1+);
Otaibi et al., 2013(1+); Sauls, 2002(1+)]
(5): The analgesic effects of cold application can be evaluated by VAS and mean
length of time before request for analgesics after CTR. (Grade of recommendation:
A)
Evidence: VAS had been shown to have high stability and reliability to assess
patient’s level as mentioned in statement 1. In Demir & Khorshid (2010) study, the
mean length of time in hours for patients in the cold application intervention group
was 0.3 and 0.43 hours longer than placebo and control groups respectively in
requesting analgesics after CTR (p<0.05), which can act as another indicator to
evaluate the analgesic effects of cold application. [Demir and Khorshid, 2010(1+)]
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Appendix 9: Cold application programme for CTS patients before CTR checklist
Patients are not applicable for this programme if they are: Unit/Dept: 1: having psychiatric diseases or dementia. Date: 2: are having poor visual acuity or blinded. 3: are oversensitive to cold and allergic to panadol.
Procedures Yes No Remarks
1 Administer 1 gram p.o. Panadol according to MAR chart after receiving doctor’s call (1 hour before CTR) and every 6 hours for
one day.
2 Apply silica cold gel packs of +4°C wrapped by dressing pads surrounding the chest tubes and anchored by mefix for 20 minutes
(counted by hourmeter) before CTR at bedside.
3 Transport patient to treatment room and position well for CTR. 4 Record patient’s pain level before CTR by using VAS in pain chart. 5 Remove the cold packs and assist doctor to perform CTR. 6 Perform pressure dressing to old drain site and record patient’s pain
level by using VAS in pain chart immediately after CTR.
7 Record patient’s pain level by using VAS in pain chart 15 minutes after CTR.
8 Record the time and pain level in pain chart each time patient requests for analgesics after CTR.
Remarks: 1: Please put a tick to ‘Yes’ column after completing a procedure before moving on to another procedure. 2: Please put a tick to ‘No’ column if the procedure is not done. Withdraw the programme and record the reasons of fail to complete the procedure in ‘Remarks’ column. 3: Please inform the corresponding CTS doctors if patient withdraw the programme due to serious responses. Doctors may need to assess the patient again to determine whether continue the CTR procedure or suspend it. Nurse for implementing the programme: Name: Signage:
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Appendix 10: Time table for implementation
Workflow Time (Month)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Preparations for presenting programme information to nursing
colleagues in ward meeting
Seek approval from DOM and COS
Forming working group for programme planning and refinement
Prepare posters and send email for promotion
4 RN receive cold application training by senior physiotherapist
before pilot study
Conduct pilot study
Evaluate and amend the protocol based on pilot study results
Training sessions provided by senior physiotherapist and working
group members to all RN
Full implementation of cold application programme
Evaluate patient’s data
Receive feedbacks from involved staffs and evaluate resources