Title. Author(s) Fung, Ching-shan.; 馮 清 珊. Citation. Issued Date

Transcription

1 Title Evidence-based clinical practice guidelines on the frequency of central venous catheter (CVC) dressing change for hematologicalmalignancy adult patients Author(s) Fung, Ching-shan.; 馮 清 珊. Citation Issued Date 2011 URL Rights The author retains all proprietary rights, (such as patent rights) and the right to use in future works.

2 Abstract of thesis entitled Evidence-based clinical practice guidelines on the frequency of central venous catheter (CVC) dressing change for hematological malignancy adult patients Submitted by Fung Ching Shan for the degree of Master of Nursing The University of Hong Kong in August 2011 Abstract Central venous catheters (CVCs) are commonly used in haematological malignancy patients. However, the problem of skin toxicity over the CVC site caused by dressing changes carried out too frequently is significant in this group of patients. Skin toxicity might increase the penetration of microorganisms which will lead to local and systemic infections, resulting in significant morbidity and mortality. At present, there are no definite guidelines on the frequency of the dressing changes in

3 the local setting, thus developing evidence-based clinical guidelines on the frequency of CVC dressing changes is necessary in order to eliminate inconsistent practices. This dissertation is a translational nursing research that aims at developing evidence-based clinical practice guidelines on the frequency of central venous catheter (CVC) dressing changes for haematological-malignancy adult patients. The objectives of this thesis are to search for existing literature on the frequency of CVC dressing changes in relation to skin toxicity; perform a critical appraisal on the literature; develop guidelines for the frequency of CVC dressing changes; assess the implementation potential of the proposed guidelines, and develop its implementation and evaluation plans. First, a systematic search on relevant literature was performed using four electronic databases. This was carried out from 1 st September 2010 to 15 th September The literature was Medline (OvidSP) August wk4 2010, CINAHL(plus) , PubMed ( ) and Cochrane Library (earliest to August 2010). Seven relevant articles, all of which are randomised controlled trials (RCTs),were retrieved. Since all the above studies are RCTs, the Critical Appraisal Skill Programme (CASP) for RCTs appraisal tool was adapted as the framework of quality of assessment (Public Health Resources Unit, 2007). After performing a critical appraisal on the reviewed studies, the level of evidence for each study was graded

4 according to the Scottish Intercollegiate Guidelines Network (SIGN) framework. The studies were rated from 1++ to 1- as the evidence level. By synthesising the data from the reviewed studies, it is concluded that extending the dressing change frequency can minimise skin toxicity without promoting catheter-related infection. Then, the implementation potential of the innovation was assessed in terms of the target audience and setting, transferability of the findings, and feasibility and cost-benefit ratio of the innovation. After assessing its implementation potential, it is found that it is feasible to implement the proposed guidelines in the target oncology setting. With sufficient evidence, clinical practice guidelines on the frequency of central venous catheter (CVC) dressing changes were developed. Recommendations on skin toxicity assessment, the frequency of CVC dressing changes, and choice of dressing material are included in the proposed guidelines. The implementation plan of the new guidelines was developed. The implementation plan involves the communication and pilot testing plans. The communication plan involves potential stakeholders, including the Nurse Specialist (NS) and Advanced Practice Nurse (APN), Ward Manager (WM), Department Operative Manager (DOM), Chief of Service (COS), and Haematological Medical Team doctors and ward nurses. After getting approval for the implementation of the innovation from the decision makers, a pilot test was carried out to test the feasibility

5 of the new guidelines. An evaluation plan was developed. Patient outcomes, health care provider outcomes and systemic outcomes were all evaluated. With the implementation of the evidence-based clinical guidelines on the frequency of dressing changes, the incidence and severity of skin toxicity over the CVC site of haematological malignancy adult patients is expected to be reduced.

6 Evidence-based clinical practice guidelines on the frequency of central venous catheter (CVC) dressing change for hematological malignancy adult patients By Fung Ching Shan BNurs (CUHK) A thesis submitted in partial fulfillment of the requirements for the Degree of Master of Nursing at the University of Hong Kong August 2011

7 Declaration I declare that this thesis represents my own works, 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: Fung Ching Shan i

8 Acknowledgements Special thanks should be given to my supervisor, Dr. Catherine Lo, from the School of Nursing at the University of Hong Kong, for her guidance and support in this entire process. I also sincerely thank my fiancé who has provided me with continuous encouragement, support, love and generosity throughout all these years. ii

9 Table of Contents Declaration... i Acknowledgements... ii Table of Contents... iii Lists of Appendices... iv Abbreviations...v Chapter 1 Introduction 1.1 Background Affirmation of the needs Research question, Hypothesis, Objectives Operation definitions...6 Chapter 2: Critical Appraisal 2.1 Searching strategy Appraisal strategy Summary of quality assessment Data Summary Data Synthesis Chapter 3 Implementation Potential 3.1 Target setting/ Audience Transferability of findings Feasibility Cost-benefit ratio of the innovation iii

10 Chapter 4 Developing Evidence-Based Practice Guidelines 4.1 Aim, Objective, Target group Rating scheme of the guideline Recommendations Chapter 5 Implementation Plan 5.1 Identification of stakeholder Communication Plan with potential users Formation of taskforce for innovation Pilot Study Plan Chapter 6 Evaluation Plan 6.1 Identifying outcomes to be achieved The nature and number of clients to be involved Data Collection and Analysis Basis for an effective change of practice Dissemination and Measure to sustain the change Chapter 7 Conclusion References iv

11 Lists of Appendices Appendix 1: Eastern Cooperative Oncology Group (ECOG) scale Appendix 2 Keywords used Appendix 3 Summary of search result Appendix 4 Clinical guideline search Appendix 5 Table of Evidence Appendix 6 Critical Appraisal Skills Programme (CASP) Appendix 7 SIGN (Scottish intercollegiate guideline network) grading system Appendix 8 Table of Quality Appraisal Appendix 9 Table of critical appraisal Appendix 10 Budget Plan Appendix 11 SIGN grading system: Grade of Recommendation v

12 Abbreviations ALL Acute lymphoblastic leukemia AML Acute Myelogenous leukemia AMOL Acute Monocytic Leukemia ANC Absolute Neutrophil count APN(s) Advance Practice Nurse(s) Ara-C Cytosine-arabinoside BMT Bone marrow transplant CASP Critical Appraisal Skill Programme CDC Centers for Disease Control prevention CI Confidence interval CINAHL Cumulative Index to Nursing and Allied Health Literature CLL Chronic Lymphoblastic leukemia CML Chronic Myelogenous leukemia COS Chief of service CRBSI Catheter-related bloodstream infection CRI(s) Central venous catheter-related infection(s) CVC(s) central venous catheter(s) DOM Department Operative Manager ECOG Eastern Cooperative Oncology Group EBP Evidence-based Practice GPP Good Practice point HL Hodgkin s lymphoma ITT Intention to treat MO(s) Medical Officer(s) n Number NA Not applicable NI Not indicated NHL Non-Hodgkin s lymphoma NPC Nasophrynx cancer ns Not significance NS Nurse specialist p Level of significance PICC Peripheral inserted central catheter RCT(s) Randomized controlled trial(s) RN(s) Registered Nurse(s) vi

13 SAA SD SIGN WM Severe Aplastic Anemia Standard deviation Scottish Intercollegiate Guidelines Network Ward manager vii

14 Chapter 1 Introduction In this chapter, the background knowledge on the use of central venous catheter (CVC), and the significance of the problem of skin toxicity over CVC site in haematological malignancy patients will be presented. Then, the research questions and objectives, as well as the operational definitions of this dissertation will be discussed. 1.1 Background Central venous catheters (CVCs) are commonly used in haematological malignancy patients. More than two thirds of these patients, both adult and paediatric, were inserted with CVCs (Ingram, Weitzman, Greenberg, Parkin, & Filler, 1991; Simon, Bode, & Beutel, 2006). CVCs facilitate complex treatments on haematological malignancy patients. This group of patients has a greater need for central venous access as they require long term intensive chemotherapy or bone marrow transplant, as well as the administration of medication, blood products, fluids, nutrition, and obtaining blood for monitoring physiological parameters. Also, CVCs help in minimising the patients discomfort as blood can be taken from the catheter directly so no further skin punctures will be necessary. However, the use of CVCs is associated with a high risk of infection. CVC is one of the major sources of infection in haematological malignancy patients (Karthaus et 1

15 al., 2002). Haematological patients receiving intensive chemotherapy or undergoing bone marrow transplants are at a high risk of infection due to their immune-compromised and neutropenic status (ANC<500/ml) (Elishoov, Or, Strauss, & Engelhard, 1998; Kappers-Klunne, Degener, Stijnen, & Abels, 1989; Landoy, Rotstein, Lucey, & Fitzpatrick, 1984; Nouwen et al., 1999; Rizzari & Conter, 1995; Sharma & Iqbal, 2005). The reported percentage of catheter-related infection (CRI) in haematological malignancy patients is 35%-41% (Adler et al., 2006; Ellis, Rhydderch, Zwaan, Guy, & Baillie, 1996; Marena et al., 2001; Vidal et al., 2003). Bone marrow transplant patients are more likely to develop CRI with an infection rate of 11.5 per thousand catheter-days (Keung et al., 1995). Complications cause by CRI can result in significant morbidity and mortality (Mermel, 2000). Catheter site serves as an entry for microorganisms to enter the body resulting in infection (Bjornson et al., 1982; Snydman, Murray, Kornfeld, Majka, & Ellis, 1982). Effective catheter site dressing is essential for preventing the catheter from the external contamination and discouraging the microorganism growth around the exit site (Treston-Aurand, Olmsted, Allen-Bridson, & Craig, 1997). Therefore nursing care including maintenance of a sterile environment for the catheter insertion site is essential to prevent CRIs. Frequency of dressing changes is one of the identified risk factors associated 2

16 with the incidence of CRIs (Hoffmann, Weber, Samsa, & Rutala, 1992; Prager & Silva, 1984). Historically, CVC dressings are changed daily or every other day (Lawson et al., 1986). However, manipulations of the catheter that are too frequent have been suggested to be a major contributing factor to CRIs (Trotter, 1998). This is because repeated changing of CVCs dressings can result in skin stripping (Dykes & Heggie, 2003). So the damaged skin might in turn increase the penetration of microorganisms resulting in local and systemic infections, which can result in morbidity and mortality. 1.2 Affirmation of the needs Significance of skin toxicity for haematological malignancy patients Skin toxicity over catheter sites caused by too frequent dressing changes is more serious in haematological malignancy patients than in other patients. It is because a complex programme of intensive high dose chemotherapy is required in the treatment of haematological malignancy. Skin toxicity usually presents itself 1-20 days after the initiation of chemotherapy (Vokurka et al., 2009). Benhamous et al (2002) observed that approximately 50% of the patients undergoing high-dose chemotherapy will develop a certain degree of skin toxicity. Skin lesions caused by catheter dressing changes can be serious in patients undergoing high dose chemotherapy and bone marrow transplants. Dressing changes that are too frequent often cause significant 3

17 skin damage around the catheter site as the skin of the affected patients is more fragile (Benhamou et al., 2002; Laura et al., 2000; Vokurka, Bystricka, Visokaiova, & Scudlova, 2009). The increased rate of skin toxicity is also caused by the use of busulfan, a cell cycle non-specific alkylating antineoplastic agent which is mainly used in bone marrow transplants (Kalifa et al., 1992). Dressing change frequency practices The Centre for Disease Control and Prevention (CDC)'s guidelines did not recommend any specific frequency of CVC dressing changes (O'Grady et al., 2002). The dressing frequency ranges from daily to weekly according to institutional policy worldwide. In the local setting, there are no definite guidelines on the frequency of dressing changes. Current CVC dressing practice in haemato-oncological setting The target haemato-oncological ward is located in a large teaching hospital. The daily change of cosmopore (a gauze dressing with non-woven polyester adhesive cover and border) by using providine-iodine as antiseptic is the current dressing practice of CVC dressing in the target setting. Routine dressing change is done in the morning. It is not uncommon to see patients requiring an additional dressing change in the evening due to the first dressing becoming soiled after their shower. There is no statistical record on the incidence and severity of skin toxicity on 4

18 CVC dressing site in the target setting. There is also no formal assessment of skin toxicity over the CVC site. However, various degrees of skin toxicity and complications are frequently observed in around 50% of the patients in the target ward. The most common types of skin toxicity are itchiness, erythema and mild ulceration. 1.3 Research question, Hypothesis, Objectives Research Question Are evidence-based clinical guidelines on the frequency of central venous catheter (CVC) dressing changes more effective than the existing dressing protocol in minimising the incidence and severity of skin toxicity in haematological malignancy adult patients? Hypothesis 1. Prolonging the dressing change frequency can reduce the incidence and severity of skin toxicity. 2. Prolonging the dressing change frequency does not increase the incidence of CRI. Study objectives The objectives of this translation nursing research are: 1. To review the evidence on the effectiveness of prolonging the frequency of CVC dressing changes in minimising skin toxicity. 5

19 2. To critically appraise, summarise and synthesise the selected research findings. 3. To develop evidence-based clinical practice guidelines on the frequency of central venous catheter (CVC) dressing changes for haematological malignancy adult patients. 4. To assess the implementation potential of the proposed guidelines. 5. To develop an implementation and evaluation plan for the proposed guidelines. 1.4 Operation definition Haematological malignancy Haematological malignancy is defined as cancer affecting one s blood, bone marrow and lymph nodes. All the diagnosis of the malignancy should be confirmed by bone marrow aspiration. Under microscopic examination, cell lineage is examined to rule out the malignancy as emphasised by WHO classification (2001). There are three groups of haematological malignancy: leukemia, lymphoma and myeloma. Leukemia is classified into the following types: Acute lymphoblastic leukemia (ALL), Acute Myelogenous leukemia (AML), Chronic Myelogenous leukemia (CML), Chronic Lymphoblastic leukemia (CLL), Acute Monocytic Leukemia (AMOL) and other leukemia. Lymphoma can be divided into two groups, 6

20 which are Hodgkin s lymphoma (HL) and Non-Hodgkin s lymphoma (NHL). Central venous catheter (CVC) Central venous catheter is a catheter placed into large veins, most commonly over the neck, chest and groin areas. There are several types of central venous catheters. They are tunneled catheter, non-tunnel type catheter, peripheral inserted central catheter (PICC), and implanted port. In this dissertation, implanted port is excluded since the device is implanted under the skin, and routine dressing is not required. Central venous catheter- related infection (CRI) The criteria used to define CRIs are based on the quantitative data below. CRIs should be confirmed by one or more of the following: site colonisation, catheter tip culture, catheter-related bloodstream infections (CRBSIs) or blood sample from the CVC. The definitions published by Centre for Disease Control and Prevention (2002) are used as follows: 1) Site colonisation: any positive cultures of the exit site or skin around the exit site or/and 2) Catheter tip culture: any positive semi-quantitative or quantitative culture from a proximal or distal catheter segment or/and 3) Catheter-related bloodstream infection: any isolation of the same organism from a 7

21 semi-quantative or quantitative culture of a catheter segment and from separate percutaneous blood culture, with no identifiable source of infection. Skin toxicity In this dissertation, the definition of skin toxicity is relatively qualitative. The following signs are considered symptoms of skin toxicity: erythema, pain, tenderness, induration and purulence. Skin toxicity is also graded according to the Eastern Cooperative Oncology Group (ECOG) scale (Appendix 1) (Laura et al., 2000). 8

22 Chapter 2 Critical Appraisal In this chapter, the search strategies, evidence extraction, critical appraisal, quality assessment, and the summary and synthesis of data will be elaborated. 2.1 Searching strategy Inclusion and Exclusion Criteria The studies are limited to randomised controlled trials in English or Chinese only. Haematological malignancy patients in all age groups and both genders, and treated with chemotherapy or bone marrow transplant with central venous catheter in-situ are included in the review. The CVC type is either tunnel or non-tunneled. The interventions should be related to the different frequencies of dressing changes in the intervention and comparison groups. The main outcomes can be either CRI or skin toxicity, or in both combinations. The outpatient population is excluded in this search strategy as the target setting is in an inpatient environment. Any implanted port is also excluded. This is because dressings are not required for it as there are no external wounds. Studies without full texts are also excluded. Keywords used The keywords used are categorised into three groups: population, intervention 9

23 and outcomes. The keywords within each group will be searched using OR while AND is used when linking two different groups. A full set of keywords used is listed in Appendix 2. Electronic database search An electronic database search was performed from 1 st September 2010 to 15 th September A systematic search on the literature reviews was performed using four electronic databases. They are Medline (OvidSP) August wk4 2010, CINAHL(plus) , PubMed ( ) and Cochrane Library (earliest to August 2010). The search yielded a total of 769 articles. The abstracts of potentially relevant papers were screened. 132 articles were identified to be eligible studies. Full papers were obtained in order to further assess the articles according to the selection criteria. Eventually, eleven articles were identified, and four duplicates were excluded. Seven relevant articles were finally retrieved. The summary of the electronic database search is presented in Appendix 3. A clinical guidelines search was also performed using multiple sources, including National Guideline Clearinghouse, CMC InfoBase, Scottish Intercollegiate Guidelines Network (SIGN), Guidelines Advisory guidelines, Guidelines International Network and Joanna Briggs Institute. The results were all irrelevant for 10

24 one systematic review extracted from Joanna Briggs Institute (CPRN, 1998). The summary of the clinical search is presented in Appendix 4. Reference list search The reference lists of selected articles were further screened by their titles. By assessing the abstract and full text of the potential articles, relevant studies that might not be included in the four electronic databases could then be retrieved. However, no new articles were found. Data extraction The following four categories of variables were then extracted from each study: 1. Target population (patients characteristics and study setting) 2. Intervention variables (types of intervention) 3. Outcome measures (incidences of complication) 4. Result The data of the seven selected papers has been translated into tables of evidence which are presented in Appendix Appraisal strategy Since all the studies are randomised controlled trials (RCTs), the Critical Appraisal Skill Programme (CASP) for RCTs appraisal tool was then adapted as the framework for quality of assessment (Public Health Resources Unit, 2007). The 11

25 details of the appraisal tool are presented in Appendix 6. After a critical appraisal of the selected studies, the level of evidence for each study was graded according to the Scottish Intercollegiate Guidelines Network (SIGN) framework in Appendix 7. The levels of evidence of studies were rated according to SIGN 50: A guideline developer s handbook Annex B (Network, 2008a). 2.3 Summary of quality assessment A summary table of an appraisal of the quality of the studies is presented in Appendix 8. In the reviewed studies, the population, interventions used and outcome measures were clearly specified. They all had clearly focused questions. All studies were RCTs, which were appropriate to test the effectiveness of the intervention. The studies were rated from 1++ to 1-, for the evidence level. Even though patients in the included studies were randomly allocated, only two studies adequately described the randomisation process (Shivnan et al., 1991; Vokurka et al., 2009). However, all studies demonstrated an equalisation effect of randomisation between the comparison groups. Four studies had insignificant differences in confounders between two groups (Benhamou et al., 2002; Engervall, Ringertz, Hagman, Skogman, & Bjorkholm, 1995; Shivnan et al., 1991; Vokurka et al., 2009). One study demonstrated significant difference in the mean age of participants (p=0.001) (Lawson et al., 1986). One study did not mention any information on the 12

26 demographic characteristics as well as any significant differences between the intervention and control groups (Laura et al., 2000). All studies were unclear about their allocation concealment. Four studies had adequate measures about the possible confounders (Benhamou et al., 2002; Brandt, De Palma, Irwin, Shogan, & Lucke, 1996; Laura et al., 2000; Vokurka et al., 2009), while the remaining three had inadequate information (Engervall et al., 1995; Lawson et al., 1986; Shivnan et al., 1991). No studies described any method of blinding. The blinding of the participants seemed to be impossible as the RCTs implemented the intervention with active involvement with the participants. The blinding of the nurses was also impossible as they needed to carry out the dressing regime differently by taking into account the comparison groups. Observer binding was possible in the RCTs but none of the studies provided any description on the binding of the observers or the data collectors. The dropout rate ranged from 0%-35%. Actually, the majority of the studies had a satisfactory dropout rate of less than 15 %, except for one study which had 35% (Laura et al., 2000). So the effect of the intervention might be underestimated. The intention to treat the analysis was done in three studies (Benhamou et al., 2002; Brandt, De Palma, et al., 1996; Shivnan et al., 1991) In all the studies, the participants in the intervention and control groups were 13

27 followed up with at the same time interval. The data was collected in the same way from the different groups in order to prevent performance bias. Clear protocols on dressing were mentioned in four studies (Benhamou et al., 2002; Brandt, De Palma, et al., 1996; Shivnan et al., 1991). The pre-education for the staff was performed in two studies (Brandt, De Palma, et al., 1996; Laura et al., 2000; Shivnan et al., 1991). This pre-education can maintain consistency in the practice. Intervention checks were performed in three studies (Benhamou et al., 2002; Brandt, De Palma, et al., 1996; Laura et al., 2000). This can ensure the compliance to the intervention throughout the trial. Only two studies had clear description on the sample size calculation which calculated the sample size using an adequate power of 0.80 (Brandt, De Palma, et al., 1996; Shivnan et al., 1991). The remaining five studies did not mention the sample size calculation (Benhamou et al., 2002; Engervall et al., 1995; Laura et al., 2000; Lawson et al., 1986; Vokurka et al., 2009). The study by Engervall, et al recruited only 32 participants in the trial. It was at a high risk of having insufficient participants to achieve statistical conclusion validity. Most studies presented their results well. Objective measurement tools such as well-established skin toxicity grading were used in the majority of the studies. Most of the results of CRI and skin toxicity were presented in percentage form. However no 14

28 mean or SD was reported, so the effect size could not be calculated. The P-value was reported in all studies when two groups were compared. However, none of them provided 95% confidence intervals, except for studies by Benhamou, et al (2002). Given the similar characteristics of the target population, the intervention and results are applicable to local settings. The details of the critical appraisal for individual study are shown in Appendix Data summary Study characteristics The seven papers were based on a study type of controlled trial with both an intervention group and a control group. The method of allocating the participants was purely random. The level of evidence ranged from 1++ to 1-. The papers were published from 1986 to Three studies were conducted in the United States (Benhamou et al., 2002; Laura et al., 2000; Lawson et al., 1986; Shivnan et al., 1991). The others were conducted in Italy, France, Czech Republic and Sweden (Engervall et al., 1995; Laura et al., 2000; Vokurka et al., 2009). There were 1199 participants in total for the seven studies. The number of participants ranged from 32 (Engervall et al., 1995) to 399 (Laura et al., 2000). Patient characteristics The participants in the four studies were candidates for bone marrow transplant 15

29 (Laura et al., 2000) (Benhamou et al., 2002; Brandt, De Palma, et al., 1996; Shivnan et al., 1991). The other three studies were on patients undergoing chemotherapy (Engervall et al., 1995; Lawson et al., 1986; Vokurka et al., 2009). Two studies did not mention the distribution of gender (Benhamou et al., 2002; Vokurka et al., 2009). The remaining five studies had similar proportions of female and male participants ranging from 1 to 81 years of age. Two studies (Brandt, De Palma, et al., 1996; Vokurka et al., 2009) reported the mean age of the participants but no age range was reported. The study by Laura, et al (2000) did not report the age of the participants. Adult patients were recruited in four studies (Brandt, De Palma, et al., 1996; Engervall et al., 1995; Lawson et al., 1986; Vokurka et al., 2009) while paediatric patients were recruited in one study (Benhamou et al., 2002). Paediatric and adult patients were both included in the same study by Shivnan, et al (1991). There were various CVC locations. Some were at the subclavian and jugular sites (Engervall et al., 1995), while others were at the subclavian site only (Benhamou et al., 2002; Vokurka et al., 2009), and one study included the subclavian, jugular and cubital sites (Lawson et al., 1986). Three studies did not identify the location of the CVCs. 60.5% of the participants were inserted with tunneled catheter while 39.5% were inserted with non-tunneled catheter. The study by Lawson et al (1986) did not report the type of catheter used. 16

30 Intervention and Control (1) Frequency of dressing In the intervention group, the frequency of dressing changes was once a week (Brandt, De Palma, et al., 1996; Engervall et al., 1995; Vokurka et al., 2009), every four days (Shivnan et al., 1991) and every 15 days (Benhamou et al., 2002). The was once every five days (for non -tunneled) and ten days (tunneled) according to type of CVC in Laura, et al (2000) study. Dressings were changed earlier if they became loose, soiled, damp, or for other significant reasons. The patients experienced a mean dressing change interval from four (Lawson et al., 1986) to eight days (Benhamou et al., 2002) in the selected studies. The majority of the seven selected studies concluded that extending the dressing change interval to once every four days to a week did not increase the risk of CRI (Benhamou et al., 2002; Brandt, De Palma, et al., 1996; Laura et al., 2000; Lawson et al., 1986; Shivnan et al., 1991; Vokurka et al., 2009). Only one study (Engervall et al., 1995) concluded that twice a week was superior to once a week dressing change. (2) Types of dressings In the intervention group, transparent polyurethane dressings were used in all studies except in one (Benhamou et al., 2002). In Benhamous et al s (2002) study, the types of dressings were used according to skin toxicity, such as the transparent 17

31 polyurethane dressing (Tegaderm) for grade 0-1, Mefix type for grade 2-3 and gauze and tape dressing for grade 4. The types of dressings used were the same in both groups, except in three studies (Brandt, De Palma, et al., 1996; Lawson et al., 1986; Shivnan et al., 1991). These three studies also compared the transparent polyurethane dressing to the gauze and tape version. (3) Antiseptic solutions The antiseptic used were identical in both the intervention and control groups in each study. Two studies used alcohol (Benhamou et al., 2002; Lawson et al., 1986). One study used povidone-iodine (Vokurka et al., 2009). 70% ethanol was used in one study (Engervall et al., 1995) while both alcohol and providne iodine were used in another (Brandt, De Palma, et al., 1996). A study also used peroxide and provdine (Shivnan et al., 1991). Providine ointment was applied to dressings in two studies (Brandt, De Palma, et al., 1996; Lawson et al., 1986). The application of antibiotic ointment was mentioned in only one study (Shivnan et al., 1991). Only one study did not indicate the type of solution used (Laura et al., 2000). Measure outcomes (1) Site colonisation Site colonisation was measured in four studies. All patients had skin culture in 18

32 three studies (Benhamou et al., 2002; Engervall et al., 1995; Laura et al., 2000) and 75 out of 103 patients had skin culture done in one study due to laboratory difficulties (Shivnan et al., 1991). Skin cultures were performed at the time of dressing change (Benhamou et al., 2002; Engervall et al., 1995). Laura et al (2000) performed skin culture at the time of enrollment and at every ten-day intervals. One study did not identify when the skin culture was taken (Shivnan et al., 1991). All studies concluded that there was no significance difference in the incidence of site colonisation if the dressing intervals were prolonged. (2) Catheter-related bloodstream infection Catheter-related bloodstream infection was measured in three studies (Benhamou et al., 2002; Brandt, De Palma, et al., 1996; Engervall et al., 1995). Blood cultures were taken in the event of fever (> degree Celsius) (Benhamou et al., 2002; Brandt, DePalma, Irwin, Shogan, & Lucke, 1996). In one study, blood was only taken from a CVC with no peripheral site (Shivnan et al., 1991). All concluded that there were no statistical differences in the rate of Catheter-related bloodstream infection between the intervention and control groups. (3) Catheter tip culture Catheter tip culture was measured in two studies, when the patients CVCs were removed (Brandt, De Palma, et al., 1996; Engervall et al., 1995). In Engervall et 19

33 al s(1995) study, more catheter tip infections were noted in the intervention group when the dressing change interval had been prolonged to once a week (p <0.05). (4) Skin toxicity Signs of inflammation were observed in four studies (Benhamou et al., 2002; Engervall et al., 1995; Lawson et al., 1986; Shivnan et al., 1991; Vokurka et al., 2009). All concluded that no statistical difference was obtained in regard to the catheter site inflammation in the interventions groups. Skin irritation was measured in one study (Shivnan et al., 1991). It concluded that there were significantly higher rates of skin irritation in the dry gauze dressing group (p<0.005). Three studies measured skin toxicity (Benhamou et al., 2002; Laura et al., 2000; Vokurka et al., 2009). Two studies concluded that CVC dressings changed at longer intervals proved efficient in reducing skin toxicity (Benhamou et al., 2002; Laura et al., 2000) while Vokurka et al (2009) demonstrated the result that there was no significance statistically in skin toxicity and having the dressing change intervals prolonged. (5) Nursing time and dressing cost Nursing time and dressing cost were measured in three studies (Laura et al., 2000; Lawson et al., 1986; Shivnan et al., 1991). Nursing time and dressing cost were significantly reduced in the transparent polyurethane dressing group (Laura et al., 2000; Lawson et al., 1986; Shivnan et al., 1991) 20

34 (6) Patients comfort Tissue trauma to wounds and peri-wound skin caused by the removal of adhesive tapes and dressings is known to exacerbate wound pain (Hollinworth & White, 2006). The level of pain was assessed in one study (Vokurka et al., 2009). It found no significant difference in pain between both groups. However, the patients level of comfort in general, as seen in their higher level of satisfaction when transparent polyurethane dressings were used with longer intervals, was reported in Shivnan et al (1991). 2.5 Data Synthesis The target population in the clinical guidelines The age of the target population in the selected studies was different. They were adult patients (Brandt, DePalma, et al., 1996; Engervall et al., 1995; Lawson et al., 1986; Vokurka et al., 2009), paediatric patients (Benhamou et al., 2002), adult and paediatric patients (Shivnan et al., 1991). The Centres for Disease Control and Prevention (CDC) suggests that both adult and paediatric patients can follow the same CVC dressing guidelines (O'Grady et al., 2002). However, it makes no specific recommendation for haematological patients undergoing therapy. In view of the insignificant differences with regard to dressing protocol in the different age groups in the selected studies, the guidelines on dressing change frequency are considered to be 21

35 applicable to all haematological malignancy patients. In the selected studies, none of the participants had their CVC inserted in the femoral site. One of the disadvantages of the femoral approach was the difficulty in keeping it sterile, as discussed in a previous study (Galloway, 2005, insertion). In view of the insufficient data from this group of patients, there is not enough evidence to support the implementation of the guidelines in the patients with CVC in femoral site. Given the best available evidence, the guidelines are only recommended for haematological patients with CVC inserted in their subclavian, jugular and upper arm veins. Frequency of dressing changes Only one study illustrated that extending the dressing change interval from twice to once a week would lead to increased CRI (Engervall et al., 1995)(level of evidence 1-). However, this study was limited by its small sample size (n=32). It decreased the precision in estimating the effect of the population, so the results would become less accurate, and limited to generalisation. The majority of the studies concluded that the dressing change interval can be prolonged to once a week. This will show no significant difference in the CRI rate. However, instead of sticking to the expected number of days originally planned, the mean interval of dressings in the studies was reduced. The main reasons for this were 22

36 soiled and detached dressings, and bleeding from the catheter site. As a result, patients experienced a mean dressing change interval from four days (Lawson et al., 1986) to eight days (Benhamou et al., 2002) in the selected studies. It is concluded that dressing change interval can be prolonged to at least four days and no more than eight days in view of not promoting the CRI while minimising the incidence of skin toxicity. However, the dressing should be changed immediately when it is loosened, soiled or if there is bleeding. Type of dressing Transparent polyurethane dressings were used in all the intervention groups with less frequency of change. Among the seven studies, three studies compared the effect of transparent polyurethane dressings and dry gauze dressings (Brandt, De Palma, et al., 1996; Lawson et al., 1986; Shivnan et al., 1991). Transparent polyurethane dressings were recommended for CVC dressing. This is because there is no difference significantly in infection rate between the two groups. Additionally, they can facilitate the inspection of the exit sites, and the dressing can be changed at longer time intervals. Dressing cost and nursing time were significantly lower in the transparent polyurethane dressing group. Although other studies have also suggested that using transparent polyurethane dressings is comparable to gauze and tape dressings in terms of incidence of CRI 23

37 (Nehme & Trigger, 1984; Zitella, 2003), the former still have its own limitations. There is concern that transparent polyurethane dressings may increase skin humidity, thus resulting in increased bacterial colonisation which will lead to CRI (Conly, Grieves, & Peters, 1989; Wille, Blusse van Oud Albas, & Thewessen, 1993). In Benhamou, et al s (2002) study, the types of dressings used were according to the grading of skin toxicity. Tegaderm, a kind of transparent dressing, was used on patients with no or minor skin toxicity while sterile gauze and tape dressings were used on patients with a higher level of skin toxicity. Overall, they suggested that using transparent dressings can lead to less frequent dressing changes without significant negative drawbacks. However, an assessment of skin toxicity prior to making the decision on the type of dressing is recommended. Type of antiseptic solution CDC strongly recommended 2% chlorhexidine in skin antisepsis for all intravenous catheters (O'Grady et al., 2002). A randomised trial concluded that the use of antiseptic solutions such as povidine-iodine, chlorhexidine and alcohol were considered to be well-tolerated and non-irritating, even in neonates present in that trial (Garland et al., 2001; Maki, Ringer, & Alvarado, 1991). However, chlorhexidine was not used in any of the selected studies. The types of antiseptic were heterogeneous, and thus not able to make conclusion on the impact of 24

38 skin toxicity. Measurement of skin toxicity The measurement of the skin conditions varied among the studies. Four studies measured the presence of erythema, tenderness, induration, or skin irritation (Brandt, DePalma, et al., 1996; Engervall et al., 1995; Lawson et al., 1986; Shivnan et al., 1991). Three studies focused on the severity of skin breakdown by using the skin toxicity grading (Benhamou et al., 2002; Laura et al., 2000; Vokurka et al., 2009). A high incidence of erythema and skin irritation was reported in catheter sites (Jones, 1987). Signs of inflammation represent at least a grade 1 in skin toxicity, according to the EGOC grading. Measuring the skin toxicity at the same time can assess the signs of inflammation. The assessment of skin toxicity is recommended in order to evaluate the impact of longer dressing change intervals in terms of any risk of skin damage and incidence of local infection. It is recommended that the EGOC grading be used as the standard grading for skin assessment. All the studies carried out an assessment of the catheter site on a daily basis, so it is also suggested that skin toxicity be accessed in routine assessment. Proper documentation is also recommended for catheter assessment (Infusion Nurses Society, 2006). 25

39 Conclusion In conclusion, there is a need to develop evidence-based clinical guidelines on the frequency of CVC dressing changes in haematological malignancy patients. The selected studies have shown that prolonging the dressing change frequency can minimise skin toxicity without promoting CRI. The choice of the type of dressing, and the assessment of skin toxicity are the main components in the proposed guidelines. 26

40 Chapter 3 Implementation Potential Prolonging the frequency of CVC dressing changes in order to reduce the incidence and severity of skin toxicity is supported, as discussed in the previous chapters. The implementation potential will be explored in this chapter. The target audience and setting, transferability of the findings, feasibility and cost-benefit ratio of the innovation will be discussed before the research evidence is translated into evidence-based clinical guidelines on the frequency of CVC dressing changes. 3.1 Target setting/ audience Target setting The evidence-based clinical guidelines are proposed to be implemented in the department of Clinical Oncology in a local teaching public hospital. The target setting is two adult inpatient wards, one female and one male. There are 32 beds in the female ward and 36 beds in the male ward, making it a total of 68 beds. The daycare center is excluded in this study. The inpatient ward serves adult patients with different types of cancer, including solid and hematological tumors. Normally 16 beds in the target setting are reserved for hematological malignancy patients. The average length of hospital stay ranges from one month to three months. Active cancer therapeutic treatment is the major treatment provided in the target 27

41 setting. Apart from the Chief of Service (COS), Department Operation Manager (DOM) and Ward Manager (WM) who are in the management level, there are altogether 40 nurses who participate in the implementation of direct patient care in the target wards. The nurses are the Nursing Officers (NOs), Advanced Practice Nurses (APNs), Nurse Specialist (NS) and Registered Nurses (RNs). Target Audience The target audience of the proposed innovation includes all adult in-patients who: are aged 18 or above; have diagnosis of hematological malignancy; have a pre-existing tunneled central venous catheter (CVC) in their subclavian, jugular and upper arm veins; have no significant local skin toxicity (Grade II or less); and are admitted to the setting for cancer therapy such as chemotherapy, palliative treatment, and bone marrow transplant preparation. 3.2 Transferability of the findings The transferability of the findings from the reviewed papers will be discussed in terms of the setting, philosophy of care, number of clients who could benefit, and time required for its implementation and evaluation. 28

42 Setting and Audience All reviewed studies were conducted in an inpatient setting. Two of them were conducted in large university-based teaching hospitals locally (Lawson, 1986 & Benhamou, 2002). The participants in the reviewed studies were similar to those in the target audience. The subjects were all in an in-patient setting. The majority of the target population in the reviewed studies were adults (Brandt, DePalma, Irwin, Shogan, & Lucke, 1996; Engervall, Ringertz, Hagman, Skogman, & Bjorkholm, 1995; Laura et al., 2000; Vokurka, Bystricka, Visokaiova, & Scudlova, 2009). Only one out of seven papers recruited both paediatric and adult subjects whose age ranged from one to 22 (Benhamou, et al., 2002). Gender criteria were not involved in the reviewed papers. The researchers recruited both male and female patients. Therefore, the findings are highly transferable to the target setting. The patients in the reviewed studies were also similar to the target audience in terms of diagnosis, treatment of the disease and catheter insertion sites. For instance, all the patients were diagnosed to have haematological malignancy. They were either undergoing chemotherapy (Lawson et al., 1986; Vokurka, et al., 2009) or bone marrow transplant (Benhamou et al., 2002; Brandt, et al., 1996; Laura, et al., 2000; Shivnan et al., 1991). The majority of the patients were having their catheter 29

43 inserted in the suclavian site (Benhamou, et al., 2002; Engervall, et al., 1995; Laura, et al., 2000; Vokurka, et al., 2009). Therefore, the characteristics of the patients are also highly transferable to the patients in the target setting. Philosophy of care In accordance with the core value of the Hospital Authority (Hospital Authority 1994), the prevailing philosophy of care in the target setting is client-centred service. The primary goal of care in the target setting is the provision of a high quality of care to patients with cancer, their families and the community the medical fraternity serves. Oncology nurses are dedicated to relieving patients of distressing symptoms, and to also promote comfort for patients in their cancer trajectory. The nurses also hold the belief that cancer patients should live with dignity. Translating evidence into practice to provide quality care to patients with cancer is one of the philosophies in the target setting. CVC dressings that are changed at longer intervals are more comfortable in that the patients experience skin toxicity less frequently. In the study, a higher level of satisfaction and comfort was reported when transparent polyurethane dressings were used and changed at longer intervals. The patients level of comfort in general was higher with the new innovation ( Shivnan et al, 1991). Moreover, the development of skin toxicity might in turn enhance the penetration 30

44 of microorganisms, resulting in local and systemic infections. This might further cause significant morbidity and mortality (Mermel, 2000). Patients comfort and quality of live are therefore promoted if they are free from any infection. With all these considerations, the proposed innovation is in line with the philosophy of care in the target unit, in terms of promoting patient care through the evidence-based practice. Number of clients benefited The innovation will benefit all the haematological malignancy patients who are admitted to the target setting since all of them are required to be inserted with CVC before their cancer treatment. For the past year, there were 100 haematological malignancy patients admitted for active and vigorous intensive treatment. Accordingly, it is estimated that 100 target patients will benefit from the new innovation each year. Implementation and evaluation The findings are generally transferable to the target setting in terms of the simple implementation and evaluation since no additional materials and manpower are required. The duration of the implementation and evaluation is during the hospital stay of individual patients. No extra hospitalisation is required for the target patients. The proposed innovation is implemented on the day of their admission and will 31

45 continue throughout their hospitalisation. The patients cancer stage, treatment progress and general condition are not considered to be factors affecting the innovation as new clinical guidelines are applicable to all target patients. 3.3 Feasibility For the implementation of the proposed innovation, the feasibility of the following factors is required to be discussed. It can be summarised in several factors which include the organisational climate, administrative support, staffing matters and consensus among other departments and resources. Organizational Climate A positive organisational climate facilitates the implementation of the innovation. The target setting is in a local university-based teaching hospital whose academic setting provides diverse opportunities for research and evidence-based practices. The organisational climate in the target setting is conducive to research utilisation. Numerous nursing care research projects have been carried out in the target setting in the past ten years. The major aim of the research project is to introduce an evidence-based nursing practice in order to provide quality care for patients in their cancer trajectory. For example, in 2006, a research funding from the Hong Kong Government was obtained to carry out studies on dressing treatment for irradiation wounds in nasophrynx cancer (NPC), and lymphedema in breast cancer patients 32

46 undergoing axillary lymph node dissection. The update on the care of cancer patients with post-radiation skin ulcers and malignant wound was presented in the 20th Annual General Meeting and Anniversary Symposium, which was organised by The Hong Kong Society for Nursing Education. Other research projects included nurse-administered chemotherapy services, and phase III randomised control trials of dressings on radiation-induced wounds. Administrative support Since the innovation is simple to implement in that it requires no additional materials and manpower, it is feasible to obtain administrative support. In order to promote the proposed practice, it is necessary to present well the evidence-based literature, framework of the guidelines, budget and schedule plans to the administration. The details will be discussed in the communication plan in the next chapter. In addition, the target setting is under the leadership of a Department Operation Manager (DOM) who provides the ward manager (WM) and nurse specialists (NS) with autonomy to initiate clinical innovations. The inviting environment in the target setting allows nurses to raise their opinions or terminate the innovation if necessary. Previous successful attempts of developing new EBP guidelines in the target setting, including cubical nursing and new pre-operation checklists, have been made. 33