Abstract of dissertation entitled. A clinical guideline for management of lymphoedema using nurse-led. manual lymphatic drainage therapy.

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1 Abstract of dissertation entitled A clinical guideline for management of lymphoedema using nurse-led manual lymphatic drainage therapy Submitted by Tang Kit Sum For the degree of Master of Nursing at the University of Hong Kong in July 2013 Breast cancer is the number one cancer in female in Hong Kong. Breast cancer-related lymphoedema causes both physical and psychological sufferings in breast cancer survivors and significantly degrades their quality of life. Medical costs for these women are substantially higher than women without lymphoedema. Effective and standardized intervention for these patients will be beneficial to both patients and healthcare institutes. The dissertation aims to evaluate the current evidence on the effectiveness of manual lymphatic drainage in managing breast cancer-related lymphoedema, to develop an evidence-based guideline for nurse-led manual lymphatic drainage in managing breast cancer-related lymphoedema as well as to assess its implementation potential and to design implementation strategies and an evaluation plan for its adoption in a local public hospital in Hong Kong. A systematic search of the literature revealed seven studies on manual lymphatic drainage for breast cancer related lymphoedema that met the selection criteria of the dissertation. Methodological quality of the selected studies was evaluated according to the method developed by the Scottish Intercollegiate Guidelines Network and data were extracted and synthesized. Five of the trials were of moderate to good methodological quality and they demonstrated that manual lymphatic drainage was safe and had additional benefits over exercise and compression alone especially in patients with early lymphoedema.

2 A protocol on manual lymphatic drainage for breast cancer related lymphoedema was subsequently developed. The implementation potential of the protocol in the local setting was established by examining its feasibility, evaluation potential and cost-benefit. Adoption of the program was found to be able to produce a potential annual saving of HK$ 444,200 for the hospital on top of benefits to patients and staff. A three-phase implementation plan was designed in which an implementation team would initiate and guide the proposed change through a careful communication plan and a pilot study would be conducted to confirm feasibility of the protocol. An evaluation plan including patient, healthcare provider and system outcomes would then help ensure the effectiveness and sustainability of the manual lymphatic drainage protocol and guide its future refinement.

3 A clinical guideline for management of lymphoedema using nurseled manual lymphatic drainage therapy by Tang Kit Sum 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 2013

4 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. Tang Kit Sum July 2013 i

5 Acknowledgements I would like to express my sincere gratitude to my supervisor, Ms Idy Fu, who has given me invaluable guidance, expert advice and enlightenment throughout the preparation of the dissertation. I would also like to extend my appreciation to my classmates of the Master of Nursing program 2013 and my hospital colleagues, who have given me so much encouragement and assistance all along the way. Last but not least, I would like to express my greatest gratitude to my family for their unfailing support during the program without which I would not have been able to complete my work. ii

6 Content Page Declaration.. Acknowledgement.. Table of content.. i ii iii Chapter 1: Introduction 1.1 Background Affirming the Need Objectives and Significance 4 Chapter 2: Critical Appraisal 2.1 Search and Appraisal Strategies Identification of studies Inclusion and exclusion criteria Data extraction Appraisal strategy Results Search results Study characteristics Methodological quality of the studies Summary and Synthesis of Data Summary of data Synthesis of data Conclusions.. 17 Chapter 3: Translation and Application iii

7 3.1 Implementation potential Target setting and population Transferability of the findings Feasibility Cost-benefit ratio Evidence-based Practice Guideline/Protocol Objectives Guideline/Protocol development process Target population Keys to level of evidence and grade of recommendations Summary of evidence-based recommendations Chapter 4: Implementation Plan 4.1 Overview of the Implementation Plan Communication Plan Identifying stakeholders Communication process Pilot Study Plan Patient recruitment Intervention Evaluation Evaluation Plan Outcome measures Data collection and analysis Determinants for effectiveness of the program. 40 iv

8 Chapter 5: Conclusions 41 Appendices.. 42 References v

9 Chapter 1 Introduction 1.1 Background Breast cancer is a worldwide problem with an incidence of 39 per 100,000 women (Globocan, 2008). It is more common in white women in Western countries with an incidence of up to 89.1 per 100,000 in the United Kingdom and per 100,000 in Belgium (Globocan, 2008). In Hong Kong, breast cancer has become the most common cancer in women since 1993 with an incidence rate of 79.4/100,000 in 2009 (Hong Kong Cancer Registry, 2012). The mainstay of treatment for early breast cancer is surgery, which may range from modified radical mastectomy, simple mastectomy to lumpectomy (Barrett, 2010). Axillary dissection is an integral part of radical mastectomy and may be performed on top of simple mastectomy or lumpectomy. In recent years, sentinel axillary lymph node dissection is preferred over axillary dissection (Williams et al., 2012). Full axillary dissection will only be performed when one or more positive nodes are found during sentinel node dissection. Radiotherapy to the breast/chest wall and/or regional lymph node may be given after surgery especially when the primary tumor is large or there are positive axillary lymph nodes. Chemotherapy and/or hormonal therapy may also be given depending on the risk of systemic disease. Breast cancer treatment especially axillary surgery and radiotherapy may disrupt lymphatic system of the upper limb leading to secondary lymphoedema (Meric, 2002; Randeer et al., 2011). Incidence of lymphoedema after breast cancer treatment varies from 25% to 38% (Clark et al., 1997; Logan, 1995) and 1

10 lymphoedema is a big problem in breast cancer survivors resulting in poor quality of life. Lymphoedema may be classified into mild (0 to 2cm), moderate (2 to 5 cm) and severe (more than 5 cm) according to the difference in circumference between the two arms (Karadibek et al., 2005). Lymphoedema is a condition of localized fluid retention and tissue swelling caused by a compromised lymphatic system. In addition to cosmetic deformity, lymphoedema may result in loss of function, infections, discomfort and psychological distress (Harris et al., 2000; Johansson et al., 2001; Pyszel, 2006) There is a wide range of interventions for post-treatment lymphoedema in breast cancer survivors with varying degrees of success and patients acceptance but there is no standard treatment as yet. Multi-layered compression bandage, simple lymphatic drainage, manual lymphatic drainage, education on skin care, exercise and electro-physical agents are some of the current methods for managing breast cancerrelated lymphoedema (Hamner et al., 2006) Manual lymphatic drainage (MLD) is a set of specialized hand movements with different sequences to provide a pumping action on the skin. It has been shown to have a number of physiological effects including increasing lymph flow and reabsorption without increasing filtration (Wittlinger et al., 1992) and hence reducing lymphoedema. Recognized schools of MLD include Foldi (Földi, 1998), Vodder (Kasseroller, 1998), Leduc (Leduc et al., 1998) and Casley-Smith (Casley-Smith et al., 1998). 1.2 Affirming the Need Secondary lymphoedema might occur in up to 38% of breast cancer patients after surgery especially in patients receiving both surgery and radiotherapy to the 2

11 axilla (Clark et al., 1997; Logan, 1995; Mortimer, 1996). In addition to cosmetic deformity, breast cancer survivors with secondary lymphoedema may suffer from a wide range of psychosocial and physical problems including functional disabilities with recurrent infections in the limb (Simon et al., 1992), psychological distress, and pain (Tobin et al., 1993) resulting in significantly poorer quality of life (Brennan et al., 1996) when compared with breast cancer survivors without lymphoedema. Among the affected women, 62% reported no more than mild lymphoedema and 38% had moderate to severe lymphoedema (Clark et al., 1997; Mortimer, 1996). Symptoms are correlated with the severity of the lymphoedema and 37% of women with mild lymphoedema and 68% with moderate to severe lymphoedema required treatments like compression bandages, skin care and exercises. (Norman et al., 2009). It has been estimated that the medical costs for women with breast cancer related lymphoedema (BCRL) was much higher than those without BCRL (Shih et al., 2009). The difference was mainly due to outpatient care, mental health service, and diagnostic imaging etc. In Hong Kong, there are almost 3,000 (Hong Kong Cancer Registry, 2012) new breast cancer patients every year and a large proportion of them may potentially suffer from BCRL. Unfortunately, the problem of BCRL is often overlooked in Hong Kong. Most of the time the condition is diagnosed late when the lymphoedema becomes symptomatic and the patients quality of life is significantly compromised. Our oncology centre is responsible for managing cancer patients in an urban area with a population of 1.8 million. Every year we treat around 700 new breast cancer patients but at present there is no guideline on the identification and management of BCRL in our department. Lymphoedema is not routinely looked for 3

12 during follow-up and the awareness of the condition is low among both health professionals and patients. Most patients with BCRL are diagnosed late when they become symptomatic with moderate to severe lymphoedema. Many of them even require repeated admission for treatment of cellulitis secondary to lymphoedema. Treatment of lymphoedema in our department is carried out mainly by occupational therapists and physiotherapists using pressure garment and physical exercise, but the result is usually unsatisfactory. Currently, there is no manual lymphatic drainage therapy provided in our department although it is practiced in a few other public hospitals. Manual lymphatic drainage provided by trained nurses has the potential of improving the effect of current treatment for BCRL in Hong Kong as a part of a complete decongestive regime. Developing an evidence-based guideline on nurse led manual lymphatic drainage therapy for managing patients with BCRL will help fill the service gap for these unfortunate patients. The guideline will help to raise the awareness of BCRL in patients and health professionals and will standardize the management of BCRL in our department so that the treatment result will be improved. 1.3 Objectives and Significance The objectives of the dissertation are: i. to evaluate the current evidence on the effectiveness of manual lymphatic drainage in managing breast cancer-related lymphoedema, ii. to develop an evidence-based guideline for nurse-led manual lymphatic drainage in managing breast cancer-related lymphoedema, 4

13 iii. to assess the transferability and feasibility of implementing the nurseled manual lymphatic drainage guideline in a local public hospital in Hong Kong, iv. to develop implementation strategies of the guideline in an oncology department, and v. to evaluate the effectiveness and compliance of the nurse-led MLD guideline. Breast cancer is the number one cancer in female in Hong Kong. Breast cancer-related lymphoedema causes both physical and psychological sufferings in breast cancer survivors and significantly degrades their quality of life (Brennan et al., 1996; Simon, 1992, Tobin, 1993). Medical costs for women with BCRL were substantially higher than those without BCRL as estimated in a US study (Shih et al., 2009). The difference (US$ 23,167 vs 14,877) was mainly due to outpatient care and treatment of infections. Effective and standardized intervention for BCRL in these patients will therefore be beneficial to both patients, and the health care institute. From patients perspective, effective and standardized treatment for BCRL will lessen their lymphoedema, alleviate their pain and sufferings, prevent complications and enhance their quality of life. From the health institute s perspective, an evidence-based guideline will provide efficacious and standardized treatment for patients with breast cancer-related lymphoedema and has the potential of reducing outpatient attendances and hospitalization due to symptoms or complications of BCRL and thereby reducing costs. 5

14 Chapter 2 Critical Appraisal 2.1 Search and Appraisal Strategies Identification of studies The following electronic bibliographical databases were first searched for potential studies: Medline, CINAHL PLUS, British Nursing Index, and PsycINFO. The keywords used were breast, cancer, carcinoma, malignancy, neoplasm, water displacement volumetry, circumference measurement, limb volume, lymphoedema, lymphoedema, manual lymphatic drainage or decongestive therapy. Titles and abstracts of the resulting citations were then screened one by one. Full text papers of studies fulfilling the inclusion criteria were retrieved. Citation lists of these papers were examined for additional studies that were potentially relevant Inclusion and exclusion criteria Only randomized controlled trials evaluating manual lymphatic drainage as a sole intervention or as a part of complete decongestive therapy in treating breast cancer related upper limb lymphoedema were included. Non-English paper, studies on lymphoedema caused by diseases other than breast cancer or studies with manual lymphatic drainage in the control arm were excluded Data extraction Data extracted from the selected studies included: study type, objective, source of funding, subject characteristics, sample size, intervention, comparison, length of follow up, outcome measures and effect size. Data extracted from each selected study were summarized in a table. 6

15 2.1.4 Appraisal Strategy Methodological quality of the selected studies was evaluated according to the methodological checklist developed by the Scottish Intercollegiate Guidelines Network (Scottish Intercollegiate Guidelines Network, 2011). Areas addressed included: clarity of research question, randomization procedure, concealment of treatment allocation, blinding process, comparability between treatment and control arm, additional treatment that might affect outcome, appropriateness and reliability of outcome measurement, dropout, intention-to-treat analysis and comparability of results among study sites. Overall assessment of the quality of each study was then carried out by evaluating the risk of bias and the generalisability of the study results. Finally the tables containing data extracted from the studies were then used for further synthesis. 2.2 Results Search Results A total of 212 citations were identified by the initial search as potentially relevant to the use of manual lymphatic drainage in the management of breast cancer related lymphoedema. 21 studies were published in languages other than English and they were not included. The titles and abstracts of the remaining 88 studies were carefully reviewed. Out of the 88 studies, only 23 of them were randomized control trials and seven studies met the selection criteria and their full text papers were retrieved for subsequent appraisal. All of them specifically studied the effect of manual lymphatic drainage in breast cancer related lymphoedema on top of standard therapy. The search history was outlined in Appendix 1. There were no duplicated 7

16 publications Study Characteristics All selected studies were prospective randomized control trials and one of them (Williams et al., 2002) had a crossover design. Six studies were performed in Europe (two of them in the United Kingdom and one each in Denmark, Belgium, Spain and Turkey) and the remaining one was conducted in Canada. No local studies were identified. All of them were single-centre trials. Adequate concealment of randomization was evident in three studies. (Devoogdt et al., 2011; Karadibak et al., 2005; McNeely et al., 2004) In four of the studies the assessors performing the outcome measurements were blinded to the treatment allocation. (Devoogdt et al., 2011; Karadibak et al., 2005; Lacomba et al., 2010; McNeely et al., 2004) In all of the trials, standard therapy (control arm) was compared to standard therapy plus manual lymphatic drainage therapy, although the definition of standard therapy varied and included one or more of the following components: patient education, skin care, exercises and compression garment or bandage. All studies included only breast cancer patients who had undergone some form of surgical treatment of the breast, although the extent of breast surgery, axillary dissection and addition of adjuvant radiotherapy or chemotherapy varied. Out of the seven studies, five were therapeutic trials (Andersen et al., 2000; Karadibak et al., 2005; McNeely et al., 2004; Stizia et al., 2002; Williams et al., 2002) using the study intervention to treat breast cancer related lymphoedema and the other two were preventive trials (Devoogdt et al., 2011 & Lacomba et al., 2010) in which the study intervention was used to prevent the development of secondary lymphoedema. None 8

17 of the studies received commercial funding. The characteristics of the seven selected studies were summarized in the tables of evidence in Appendix Methodological Quality of the Studies In all seven studies under review, the research question and objectives were clearly defined. All of them were prospective randomized controlled trials with appropriate comparison group. However, two of the studies did not report the detail of their randomization methods (Andersen et al., 2000; Williams et al., 2002) and the appropriateness of the randomization methods used could not be assessed. The remaining five studies employed acceptable methods of randomization. Among them, three studies used computer programs or computer generated codes for randomization. One study used concealed envelopes (Karadibak et al., 2005) and the last one randomized using stratified permutated blocks assigned according to patient identity number (Devoogdt et al., 2011). Stratification was used to reduce the potential confounding effect of body mass index and axillary radiotherapy. Randomization was adequately concealed in three studies (Devoogdt et al., 2011; Karadibak et al., 2005; McNeely et al., 2004). Owing to the nature of the treatment, it is difficult to blind the subjects but blinding of the assessors is possible. In four studies (McNeely et al., 2004; Karadibak et al., 2005; Lacomba et al., 2010; Devoogdt et al., 2011), blinding of the assessors was employed to minimize bias in measuring the outcomes. Blinding was not mentioned in the remaining three trials. (Andersen et al., 2000; Stizia et al., 2002; Williams et al., 2002). Dropout rate was acceptable at less than 20% (SIGN, 2011) in all seven trials. It ranged from 3.3% to 12%. Five of the studies had dropout rate of less than 10% and only two had attrition rate of 10% or more. In all studies, the patient characteristics between the intervention group and the comparison group 9

18 were comparable and not statistically different. However, only two studies analysed the data using intention-to-treat principle (Devoogdt et al., 2011; Andersen et al., 2000). The primary outcome, although varied among different studies, was clearly defined and standardized in all trials. Assessment was performed by up to at most a few trained assessors to ensure consistency in measurement in all studies and extra efforts, like blinding of assessors to treatment, were made to minimize inter- and intraobserver variability in two studies (Devoogdt et al., 2011; McNeely et al., 2004). In Devoogdt s study, assessors were provided with one-month training before data collection. In McNeely et al. s study, a series of pilot studies was performed to establish inter-rater and intra-rater reliability of the assessors. Both preventive trials (Devoogdt et al., 2011; Lacomba et al., 2010) were designed to detect a 20% difference in the cumulative incidence of arm lymphedoedema, at a type I error of 5% with power of 80% and 70% respectively. Likewise two therapeutic trials (McNeely et al., 2004; Andersen et al., 2000) were designed to detect a difference of 20% in lymphoedema volume at a type I error of 5% with power of 80% and 90% respectively. The study by Stizia et al. (2002) reported a power of 34% only but did not give detail about its calculation. Although the result of the study favoured MLD, it did not reach statistical significance. The studies by William et al. (2002) and Karadibak et al. (2005) did not report any power calculations. All of them were single centre trials and generalizability of their results was slightly limited, although the results are still likely to be applicable to the local setting as the patient characteristics and breast cancer treatments were similar to the local situation. 10

19 Overall speaking, five out of the seven trials were of moderate to good methodological quality. The three studies with good quality were the ones carried out by Devoogdt et al., (2011), Lacomba et al., (2010) and McNeely et al., (2004). Two studies had fair quality only and they were subjected to high risk of bias (Andersen et al., 2000; Williams et al., 2002). Quality assessment of individual study was tabulated in Appendix Summary and Synthesis of Data Summary of Data Patients included in the studies were rather homogeneous in terms of their demographics and breast cancer treatment. The mean age of the subjects in the studies was around fifty-five years old, except for the study by Sitzia et al., (2002) in which patients were slightly older with a mean age of around seventy years old. Most patients, except for two patients in Sitzia et al. s trial (2002) and one patient in Williams et al. s study (2002), recruited into the studies received surgery to the breast and axilla as well as radiotherapy (around 80% of the subjects in 5 studies, more than 50% in Andersen et al. s study (2000) and 100% in Karadibak et al. s trial (2005)). They were the exact group of patients with the highest risk of developing secondary lymphoedema after breast cancer treatment. However, the definition of lymphoedema and the degree of lymphoedema of the patients differed quite a bit among the studies making interpretation of their results difficult. Andersen et al. (2000) defined lymphoedma as a difference in volume between the two arms of at least 200 ml and/or a difference between the circumference of the two arms of at least 2 cm. Sitzia et al. (2002) defined lymphoedema as Percentage Change in Excess Volume (PCEV) of 11

20 20% or more whereas Williams et al. (2002) considered an excess volume of more than 10% as the criteria for diagnosing lymphoedma. McNeely et al. (2004) and Karadibak et al. (2005) categorized lymphoedema according to the excess volume and difference in circumference of the two arms respectively. McNeely et al. (2004) classified patients with 15% or less excess volume as having mild lymphoedema, 16 to 37% as having moderate lymphoedma and more than 37% as severe lymphoedema. Karadibak et al. (2005) defined mild lymphoedema as less than 2 cm difference in arms circumference, moderate lymphoedema as 2 to 5 cm difference and severe lymphoedema as more than 5 cm difference. If we adopt the classification by McNeely et al. and Karadibak et al., then we can see that McNeely, Karadibak and Williams included patients with all severity of lymphoedema (mild, moderate to severe) whereas Andersen and Sitzia recruited only patients with moderate to severe lymphoedema. The two preventive trials defined lymphoedema as a difference of more than 2 cm between the two arms. In all of the trials, standard therapy was compared to standard therapy plus manual lymphatic drainage therapy, although the definition of standard therapy varied and included one or more of the following components: patient education, skin care, exercises and compression garment or bandage. However, they differed in the exact MLD technique and the duration of treatment and that could potentially explain the differences in the conclusions among the trials. Andersen et al. (2000) and Sitzia et al. (2002) delivered 8 and 10 sessions of MLD over 2 weeks respectively. Williams et al. (2002) gave 15 sessions of MLD over 3 weeks while McNeely et al. (2004) and Karadibak et al. (2005) used 20 and 12 sessions of MLD over 4 weeks respectively. Lacomba et al. (2010) delivered 9 sessions of MLD over 3 weeks starting about one 12

21 week after surgery whereas Devoogdt et al. (2011) gave 40 sessions over 20 weeks starting around 5 weeks after surgery. In Sitzia et al. s study (2002), MLD was performed by a nurse MLD therapist, whereas MLD was performed by one physiotherapist in McNeely et al. s (2004) and Locamba et al. s study (2010). In Williams et al. study (2002) three qualified therapists delivered MLD, while in Devoogdt et al. s study (2011), it was performed by four therapists. Andersen et al. (2002) and Karadibak et al. (2005) did not mention the number of MLD therapists involved in their studies. For the standard therapy, in all five therapeutic trials, some form of compression (compression bandage, compression garment and elastic sleeves) was used. Although patient education was only mentioned in two studies (Andersen et al., 2000; Williams et al., 2002) as a part of the standard therapy, it can be safely assumed that some form of patient education was also present in the other three studies as patient education is an essential part of modern health care. Exercise was also a part of the standard therapy in the studies by Andersen et al. (2000), Sitzia et al. (2002) and Karadibak et al. (2005). In the two preventive trials, only exercise and patient education formed the standard therapy and compression was not used, as secondary lymphoedema had not yet developed. Data extracted from the seven selected studies were summarized in the tables of evidence in Appendix Synthesis of Data Among the five therapeutic trials, three of them took percentage reduction in lymphoedema volume as the primary endpoint, although they named the outcome in slightly different ways (Andersen et al., 2000; Sitzia et al., 2002; Karadibak et al., 13

22 2005). Percentage reduction in lymphoedema volume was calculated by the following formula: ( OA post NA post ) OA pre NA pre ( ) ( OA pre NA pre ) *100% Where OA post = Volume of affected arm after treatment; OA pre = Volume of affected arm before treatment; NA post = Volume of normal arm after treatment; NA pre = Volume of normal arm before treatment However, water displacement method, which is regarded as the gold standard for measuring arm volume, was only used in one study (Karadibak et al., 2005) while various formulae (truncated cone formula, piecewise quadratic approximation etc.) were used to estimate limb volume from arm circumference measurement in the other studies and that obviously was not as accurate as water displacement method. In two studies (Williams et al., 2002; McNeely et al., 2004), reduction in absolute lymphoedema volume was used as the primary endpoint instead. McNeely et al. (2004) also measured limb volume with the water displacement method but listed percentage reduction in lymphoedema volume as a secondary endpoint only. Shoulder mobility (Andersen et al., 2000; Karadibak et al., 2005) and quality of life (Andersen et al., 2000; Williams et al., 2002) were secondary endpoints in some of the trials. In all five therapeutic trials, MLD combined with standard therapy (often known together as complicated or complete decongestive therapy) resulted in improvement in the primary outcome. Their effect sizes for reduction in lymphoedema volume were comparable: 43% at 4 weeks for Andersen et al. s study, 33.8% at 2 weeks for Sitzia et al. s study, 46.1% at 4 weeks for McNeely et al. s trial 14

23 and 55.7% at 4 weeks for Karadibak et al. s trial. For the two studies using reduction in absolute lymphoedema volume, the effect sizes were, however, quite different: 260 ml in McNeely et al. s study using water displacement measurement and 71ml in William et al. s study using estimation from arm circumference measurement. The discrepancy could probably be accounted for by the different methods used in measuring limb volume. These results demonstrated that MLD in combination with standard therapy was a safe and effective treatment for BCRL patients. Moreover, in all of the therapeutic studies except for Andersen et al. s study (2000), MLD combined with standard therapy achieved a greater improvement than standard therapy alone showing that MLD might provide additional benefit on top of standard therapy to the patients. However, the differences between MLD with standard therapy and standard therapy alone reached statistically significance only in Karadibak et al. s study (2005) and for the mild lymphoedema group in the subgroup analysis by McNeely et al. (2004). In William et al. s (2002) study, the difference just failed to reach statistical significance (p=0.053). There might be several potential explanations for the discrepancy: i. MLD might only add to standard therapy in patients with lesser degree of lymphoedema but would not give additional benefit in patients with severe lymphoedema which was more difficult to treat. The three trials with positive or close to positive results (Karadibak et al. s, McNeely et al. s and Williams et al. s studies), unlike the other two, all included patients with lesser degree of lymphoedema. The positive results in McNeely et al. s mild lymphoedema subgroup and Lacomba et al. s preventive trial (2010) provided additional support to this postulation. 15

24 ii. The duration of treatment might be important. In Karadibak et al. s and McNeely et al. s studies, MLD was given for 4 weeks and in Williams et al. s study, MLD was given over 3 weeks compared to 2 weeks in Andersen et al. s and Sitzia et al. s studies. 2-week treatment might not be enough to show the full benefit of MLD and 4-week treatment is required. iii. Most of the trials were designed to detect a difference of 20% between MLD in combination with standard therapy and standard therapy alone at a high power. It is likely the actual difference between MLD combined with standard therapy and standard therapy alone is smaller than 20% and hence the inconsistency in results among the studies. In Sitzia et al. s study (2002) and McNeely et al. s (2004) overall analysis, the differences between MLD combined with standard therapy and standard therapy were only 11.8% and 7.5% respectively. Even in trials with positive results, the differences in lymphoedema volume between MLD and standard therapy were not consistently over 20% (19.7% in Karadibak et al. s study, 2005 and 28% in McNeely et al. s subgroup analysis, 2004). In the two preventive trials of Lacomba et al. (2010) and Devoogdt et al. (2011), the incidence of secondary lymphoedma was the primary endpoint. Both studies defined secondary lymphoedema as a difference of more than 2 cm in the circumference of the two arms at two measurement points and examined the additional benefit of MLD in preventing secondary lymphoedema in breast cancer patients after surgery and axillary dissection. Both studies had good methodological 16

25 quality with proper randomization, blinding, and standardized and reliable outcome measurement. The studies were designed to have 70% (Devoogdt et al., 2011) and 80% (Lacomba et al., 2010) power respectively to detect a difference of 20% in the cumulative incidence of secondary lymphoedema. Patients characteristics were similar between the two trials with similar average number of axillary lymph nodes removed and similar proportion of patients receiving radiotherapy. The proportion of patients receiving mastectomy was however greater in Devoogdt et al. s study (around 68% versus 36%). The major difference in the intervention employed in the two preventive studies lied in the exact technique and duration of the MLD treatment delivered. In Lacomba et al. s study, the Leduc school of MLD was applied for 9 sessions over three weeks starting one week after surgery and in the Devoogdt et al. s study, the Vodder school of MLD was applied for 40 sessions over 20 weeks starting around 5 weeks after surgery. In Lacomba et al. s study, 16% patients developed secondary lymphoedema at one year after surgery. There was a significant difference in the incidence between MLD group and control group (7% vs. 25%, p = 0.01). In Devoogdt et al. s study, however, at 12 months after surgery, the cumulative incidence rate of arm lymphoedema was comparable between the intervention group and control group (24% vs. 9%, p=0.45). Possible explanations for the discrepancy include: treatment was started earlier in Lacomba et al. s trial (one week after surgery vs. 5 weeks after surgery), different schools of MLD (Leduc versus Vodder) were used and patients recruited were at slightly higher risk of developing secondary lymphoedema in Devoogdt et al. s trial (68% mastectomy vs. 36% mastectomy) Conclusions 17

26 i. Manual lymphatic drainage is safe and efficacious when combined with standard therapy including skin care, patient education, exercises and compression bandage in managing patients with breast cancer related lymphoedema. ii. Manual lymphatic drainage in combination with exercises is helpful in preventing breast cancer related lymphoedema. iii. Manual lymphatic drainage may have addition benefit over standard therapy especially in patients with early lymphoedema and early recognition of lymphoedema is important. iv. It is worthwhile to introduce manual lymphatic drainage to supplement current treatment in managing breast cancer related lymphoedema in the local setting. 18

27 Chapter 3 Translation and Application From the foregoing systematic review of randomised control trials, it has been demonstrated that manual lymphatic drainage (MLD) is a safe and efficacious procedure when combined with standard therapy in managing patients with breast cancer related lymphoedema (BCRL). Moreover, the procedure is particularly beneficial in patients with early lymphoedema and hence early recognition of BCRL is important. However, MLD is not a part of the management for patients with BCRL in the local setting at the moment. In the first part of this chapter, the implementation potential of manual lymphatic drainage in managing BCRL patients in the target hospital will first be examined by considering the transferability of the findings of the reviewed studies, feasibility and the cost-benefit ratio of the procedure in the local setting. In the second part, an evidence-based practice guideline, based on the data synthesized from the reviewed studies in chapter two, will then be developed to guide and facilitate the implementation of MLD in the target hospital. 3.1 Implementation potential Target setting and population The target setting is a female ward of a local oncology centre within a regional hospital that serves a quarter of the population of Hong Kong. The centre provides comprehensive cancer care, including radiotherapy, chemotherapy and palliative services, to its patients with multidisciplinary support and collaboration from other 19

28 departments of the hospital e.g. surgery, clinical psychology, physiotherapy, occupational therapy and social service. There are three thousand new cancer patients every year and among them seven hundred are breast cancer patients. The female oncology ward houses thirty-three beds including four isolation rooms and it is one of the few wards in Hong Kong with an integrated physiotherapy room inside the ward. MLD is intended to be used on early breast cancer patients of the centre who are eighteen years old or above and suffering from lymphoedema after curative surgery and/or radiotherapy Transferability of the findings The basic characteristics of the target population in the local setting are similar to the population studied in the reviewed trials (see Appendix 4). Both groups consist of early breast cancer patients aged 18 or above with unilateral breast cancer related lymphoedema after curative surgery and/or radiotherapy. Both groups have a mean age of around fifty-five and the only difference between the two groups is their ethnicities. The target population consists of Chinese almost exclusively, whereas the population of the reviewed studies was composed mainly of westerners from different countries of Europe and North America. However, there is no evidence to suggest that MLD works differently in different ethnic groups. The philosophy of care prevailing in the local setting is employing patient education, exercise and non-invasive physical treatment to alleviate the physical and psychological complications of BCRL in breast cancer patients. It is fundamentally the same as that of adding MLD to standard therapy in the reviewed research. The introduction of MLD in the local setting may improve patients and staff s awareness of the problem and enhance the efficacy of current therapy for patients with BCRL. 20

29 In the local setting, there are around seven hundred new breast cancer patients every year. Although the incidence of BCRL varies significantly among centres and may be as high as 38% (Logan, 1995; Mortimer, 1996; Clark et al., 1997), there will be a sufficiently large number of patients (35 to 70) in our centre who could benefit from the new treatment even assuming a modest incidence of 5 to 10%. MLD is a relatively simple non-invasive physical procedure with minimal additional requirement on top of standard therapy and the most time consuming part of implementing the procedure will be training of nurses on MLD techniques which will take about three months. Since the effect of MLD on breast cancer related lymphoedema (McNeely et al., 2004; Karadibak et al., 2005) is usually apparent shortly after completion of the intervention (about two to twelve weeks), evaluation of the new program may be carried out one year after implementation Feasibility The feasibility of implementing MLD in the target oncology centre will be considered from the perspectives of staff, environment, intervention and potential for evaluation. Staff In the target ward, there are 21 registered nurses (RN), 3 advanced practice nurses (APNs) and a ward manager (WM). In addition, two experienced physiotherapists are assigned to look after patients of the ward. Most of the nurses are experienced nurses who have worked in oncology wards for more than five years and ten had completed oncology specialty courses. Although none is conversant in the technique of MLD, most of them are experienced in assessing BCRL and managing patients using standard therapy like patient education, exercise and pressure garment. 21

30 Furthermore, there is an atmosphere and culture of continuing professional development and sub-specialization in the ward. With support and encouragement from the department in terms of training fund and study leave or compensatory offhours, all nurses attend nursing and oncology courses regularly. Since the staffing level of the ward is relatively good, many nurses have already been taking up additional responsibilities such as infection control, occupational safety, wound care, palliative care and resuscitation training as sub-specialization. Therefore, it is highly likely that the introduction of MLD will be welcomed by nurses of the department. With the support of the program by DOM and Consultant of the ward, identifying five nurses to be trained in MLD techniques by an external MLD expert and implementing the new treatment in the local setting are totally feasible. Environment Although the occupancy rate of the ward is high (around 95%) most of the time, it is spacious by the standard of a typical ward in the hospital. There are 34 beds, divided into 5 cubicles, including 4 isolation rooms for neutropenic patients and radiation protection. In addition, there is an interview room for counseling patients and their relatives with privacy and an integrated physiotherapy room with various equipment for carrying out physiotherapy in the ward. The physiotherapy room is situated away from the cubicles and is almost half as big as one cubicle. It has a low utilization rate at the moment and is the ideal locality for implementing the new program where assessment of BCRL, standard therapy and MLD may all be carried out with adequate privacy within the same location without interfering with the routine operations of the ward such as ward rounds, administration of medications and mealtime. 22

31 Intervention MLD is a type of simple non-invasive physical technique for the treatment of lymphoedema. It consists of skin massage carried out by a trained therapist, who uses different hand movements and sequences which are designed to increase lymph flow of the affected limb (Wittlinger et al., 1992). Each patient is advised to have three MLD sessions per week, for a total of 12 sessions over 4 weeks. Each session will last approximately 60 minutes. Apart from staff being trained to deliver MLD and a venue with adequate privacy for carrying out the procedure, minimal additional resources are required. In the proposed MLD program, a water tank is needed for the water displacement volumetry to measure the degree of lymphoedema. The radiotherapy workshop of the department, responsible for maintaining radiotherapy machines and building tools and equipment for delivering radiation treatment, will custom make a water tank for the MLD program at a minimal cost. As there is no expertise in MLD treatment, training of the staff on MLD techniques is essential. A qualified MLD trainer working in another public hospital has been identified and agreed to conduct the required training for the staff. Potential for evaluation The efficacy of the new treatment may be readily evaluated by measuring reduction in the degree of BCRL using water displacement volumetry and assessing improvement in quality of life with the help of EORTC QLQ C30/BR23 self-report questionnaires (EORTC, 2012; Groenvold M, 1997) (See Appendix 5). Pre-MLD therapy assessments will be performed and further evaluations on lymphoedema volume, quality of life and signs and symptoms of infections will be carried out at one 23

32 month, three months, six months and one year after treatment. The assessments will be arranged on the same day as a patient s oncology follow-up as far as possible Cost-benefit ratio The costs and benefits associated with an innovation must be carefully examined before one could decide whether to proceed to implementing the new treatment. The costs and benefits associated with MLD may be analyzed at several different levels: individual, institution and community. Individual To the patients, the most obvious benefit will be reduction in lymphoedema volume and hence relief of its associated symptoms, pain and shoulder mobility leading to improvement in quality of life. The studies of Andersen et al. (2000), Sitzia et al. (2002), McNeely et al. (2004) and Karadibak et al. (2005) had showed that after MLD treatment, lymphoedema volume was reduced by 30-50%. Williams et al. (2002) reported a significant reduction in depression and sleep disturbance scores by 7 and 9 points respectively and a nine-fold reduction in the odds of pain after MLD treatment. Furthermore, Ko et al. (1998) found that the incidence of cellulitis decreased from 1.10 to 0.65 infections per patient per year after completing lymphoedema therapy. With improved quality of life and shoulder mobility, and less hospitalisations, patients with BCRL will be able to better enjoy their lives or even return to productive occupations. From the reviewed studies, it has been observed that MLD is a safe procedure with minimal risks to patients. There is a theoretical risk that massage and mechanical compression of MLD may promote metastases by mobilizing dormant tumor cells (International Society of Lymphology, 2003). However, since only early breast cancer 24

33 patients without any evidence of metastases are included in this program, the risk is negligible. To patients, the main cost is the time spent for the intensive MLD sessions, however, it could be offset by spending less time and money for the treatment of cellulitis. To health care workers, the main benefits are better morale and job satisfaction from helping their patients and professional development from learning new skills and knowledge. Moreover, the rapport between patients and health care workers will be further improved because of the frequent contacts and cohesion among staff may be strengthened when they work together as a MLD team. Repeated MLD deliveries over a prolonged period may cause occupational injury from repetitive strain. Nevertheless, with proper training and frequent rotation among trained nurses, the risk may be minimized. Some nurses may feel stressful because of the introduction of a new practice and increase in workload. The problem is usually temporary and may be lessened with experience, training and appropriate scheduling of duties. Institution To the institution, the main benefit is the reduction in material cost associated with hospitalisation for treatment of cellulitis complicating BCRL. The cost of implementing the new intervention will include the expenses required for manpower, training and other resources such as education materials. Overall, the reduction in cost from reduced hospitalisation is much more than the cost of implementing the proposed intervention (See Appendix 6 & 7). The saving could be as much as HK444,200 per year. Non-material benefits may include development of new expertise in the organization and enhancement of institutional reputation and staff 25

34 morale. Risks to the institution include increase in burden on manpower and potential occupational injury to staff which can be minimized by proper staff training and frequent rotation. Community The main benefit to the community as a whole is reduction in health care cost from reduction in hospitalisation. Furthermore, a number of the patients may return to productive employment after receiving the new intervention resulting in higher productivity and benefit to the community. From the above analysis, it can be seen that the benefit of implementing the proposed new intervention is likely to outweigh its cost. 3.2 Evidence-based practice guideline/protocol The proposed nurse-led MLD program for patients with BCRL is transferable and feasible in the local setting. It is also safe and cost-effective. An evidence-based practice guideline will be developed in this section to serve as guidance for implementing the new intervention Objectives The protocol aims at providing evidence-based guidance on the management of patients with breast cancer-related lymphoedema using MLD in the oncology department of a local hospital in order to: i. select appropriate patients with BCRL to receive MLD, ii. iii. standardize the management of patients with BCRL, serve as a quick reference for the use of MLD in BCRL patients. 26

35 3.2.2 Guideline/Protocol Development Process The process was largely based on the system developed by the Scottish Intercollegiate Guidelines Network (SIGN) (SIGN, 2011) with some modifications to simplify the process. The first step was to formulate the appropriate research question and then literature databases were searched systematically using keywords to identify relevant trials. The methodological quality of studies fulfilling the section criteria was then carefully assessed with the help of SIGN checklists. Data from the selected studies were then extracted and summarized and finally synthesis of data was performed to generate evidence-based recommendations. Details on the development process were discussed in chapter Target population Patients with breast cancer related lymphoedema admitted to the department of oncology of a local public Hospital. Inclusion criteria: Aged 18 or above Female with histologically confirmed breast cancer Undergone unilateral surgery with curative intent for early breast cancer with or without radiotherapy or chemotherapy Unilateral upper limb lymphoedema on the same side of the breast cancer Mild to moderate lymphoedema (150 to 500 ml difference in arm volume between the two arms) Exclusion criteria: Non breast cancer treatment related lymphoedema Receiving ongoing cancer treatment (e.g. radiotherapy or chemotherapy) 27

36 except hormonal therapy or targeted therapy Presence of loco-regional recurrence or metastatic disease Signs of infection in the affected limb Pregnant patients Keys to Level of Evidence and Grade of Recommendation In this evidence-based practice protocol on nurse-led manual lymphatic drainage service for patients with breast cancer related lymphoedema, the system developed by the Scottish Intercollegiate Guidelines Network [SIGN] (SIGN, 2011) was used to indicate the level of evidence and grade of recommendation of each evidence-based recommendation (Appendix 8) Summary of Evidence-based Recommendations A summary of the evidence-based recommendations, formulated from the synthesis of studies reviewed in chapter two, is presented below. The full evidencebased protocol may be found in Appendix 9. Assessment of lymphoedema Recommendation 1: Using water displacement volumetry to measure the affected arm volume as the outcome measure of secondary lymphoedema. (Grade of recommendation: A) Recommendation 2 Treating patients with mild to moderate secondary lymphoedema using manual lymphatic drainage plus standard therapy. (Grade of recommendation: A) Delivery of Manual Lymphatic Drainage 28

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