Evidence-Based Assessment and Outcomes Following Lymphedema Treatment





Key Points





  • Complete decongestive therapy remains the only lymphedema treatment that is supported at the highest level of evidence.



  • Health-related quality of life (QOL) is a multidimensional construct that encompasses physical, functional, emotional, and social well-being parameters.



  • A variety of QOL instruments have been used to capture outcomes in lymphedema patients, but some of these instruments were not sensitive to lymphedema-specific outcomes.



  • Lymphedema-specific symptom assessment tools may be more sensitive than other instruments to clinically meaningful changes in patients with lymphedema.



Introduction


Lymphedema continues to be a significant health issue for cancer survivors, demonstrated in the 2006 and 2010 Livestrong cancer survivor surveys. Among the 6593 survivors of various types of cancer who completed the questionnaires, lymphedema was the sixth most frequently reported physical issue; lymphedema was of increasing concern for 21% of respondents in 2006 and for 25% of respondents in 2010. Of the respondents, 53% had their cancer treated with surgery or radiation, with or without adjuvant systemic therapy. Recent Livestrong surveys in 2012, 2014, and 2015 have focused on additional concerns for persons living with lymphedema, such as survivorship care plans and financial and return to work issues.


Standard-of-care lymphedema treatment is a management-based program providing symptomatic relief but requiring lifelong compression, self-massage, and, in some cases, regular visits to a lymphedema therapist for bandaging, education, and manual lymphatic drainage. Although some surgical management techniques offer patients an opportunity to forgo lifelong treatment and, in some cases, to forgo ongoing compression, little evidence exists for the long-term efficacy of these relatively novel procedures (see Chapter 26 for discussion of lymphedema surgical management techniques).


Because quality of life (QOL) outcomes have become a subject of increasing focus as primary or secondary outcomes in most clinical trials, a variety of general, malignancy-specific, and symptom-specific self-report instruments have been developed and used to assess QOL and symptoms in patients who have or are at risk for lymphedema. This chapter will provide an overview of the published evidence for the nonsurgical treatment of lymphedema, the assessment of patient-centered outcomes, and specific QOL and symptom assessment tools that have been used to evaluate patients with lymphedema.


Nonsurgical Treatment of Lymphedema


The traditional, gold standard treatment for lymphedema remains complete decongestive therapy (CDT). In the treatment phase of CDT, trained lymphedema therapists apply multiple modalities, including manual lymph drainage, multilayer short-stretch compression bandaging, therapeutic exercises, skin care, elastic compression, and education in self-maintenance. After the treatment phase, which usually lasts 3–8 weeks, the patient is expected to continue into the maintenance phase, which includes self-administered lymphatic drainage, exercise, skin care, and compression garments.


A recent systematic review by Lasinski et al. includes 8 randomized controlled trials and 10 prospective cohort studies that examined the outcomes associated with CDT ( Table 25.1 ). The authors concluded that the reviewed studies were moderately strong but lacked consistent, objectively collected data and that several of the studies describing consistent interventions often bundled CDT with other interventions. Findings from these data indicate that CDT is effective in reducing limb volume. Bundling treatment modalities makes it difficult to determine the overall efficacy of a single component of the CDT treatment schema; however, findings from these studies indicate that CDT is effective in reducing limb volume.



Table 25.1

Level of Evidence Scoring System.

From Sullivan D, Chung KC, Eaves 3rd FF, et al. The level of evidence pyramid: indicating levels of evidence in plastic and reconstructive surgery articles. Plast Reconstr Surg. 2011;128(1):311–314.





































Level Evidence for Therapy/Treatment/Prevention
1a Systematic review with homogeneity of randomized controlled trials
1b Individual randomized controlled trials with narrow confidence intervals
1c All-or-none case series
2a Systematic review with homogeneity of cohort studies
2b Individual cohort study
2c Outcomes research; ecological studies
3a Systematic review with homogeneity of case studies
3b Individual case-control study
4 Case-series and poor-quality cohort or case-control studies
5 Expert opinion without explicit critical appraisal


Other nonsurgical treatments can be considered for treatment of lymphedema. A systematic review of complementary, alternative, and other non-CDT lymphedema treatments found that treatments like these were widespread but poorly supported by evidence. In this review, the lymphedema therapies were categorized as either physical agents or modalities of contemporary value. The physical agent modalities included ultrasound therapy, electrically stimulated lymphatic drainage, high-voltage electrical stimulation, diathermy, low-level laser therapy, hyperbaric oxygen therapy, elastic taping, and acupuncture. Among the modalities of contemporary value were internationally designed at-home units devised to complete manual lymph drainage through circular massage motions, aqualymphatic therapy, and extracorporeal shockwave therapy. Most of these studies were completed with a small convenience sample or a case series and have not been replicated. Also, very few of these studies used completely objective measures of limb volume reduction, such as circumference, perometry, water displacement, or bioimpedance; subjective measures including symptom assessment and clinical examination were used to identify the pre- and post-treatment changes, which limit the validity of the data.


Patient-Centered Appraisal


The evaluation of patient-centered outcomes is important in identifying treatment-associated objective and subjective outcomes and can be defined using various tools—most commonly, QOL instruments, symptom assessment tools, measures of functional status, and global well-being health ratings. The World Health Organization clarifies that health-related QOL is not only the absence of illness but also broader well-being in the physical, social, and mental domains. Subjective outcome appraisal is a critical component of outcome assessment for any treatment regimen. Thus, the objective appraisal of lymphedema should not exclusively evaluate reduction in limb volume. Indeed, most patients with lymphedema have complaints related to body image, psychosocial barriers, and emotional issues.


The most effective way to capture changes in these patient-centered outcomes is a prospective, longitudinal assessment that collects information at baseline (prior to the intervention), at time points throughout the intervention, and within the maintenance phase following treatment. However, in the absence of longitudinal data, cross-sectional data can provide important insights on the effect of lymphedema treatment on overall QOL.


Some challenges in the evaluation of subjective, patient-reported QOL outcomes are often-observed ceiling effects, in which scores naturally cluster toward the top of the spectrum of outcomes. This may indicate that the tool being used lacks sensitivity to capture the magnitudes of outcome changes, which can result in reporting of limited changes with unclear clinical significance. Therefore, studies that define minimally important clinical differences in outcome measures within a population allow clinicians to interpret important, albeit often modest, changes in subjective outcomes over time. Conversely, subtle differences in scores may indicate important changes in these outcomes and should not be neglected. In an oncologic setting, a contemporary evaluation of health-related QOL takes continuous score distributions and categorizes them according to the extent of the changes in those scores. Despite the challenges capturing true outcomes over time in the evaluation of patient-reported outcomes, these data provide insight that cannot be gained from objective assessments alone.


Quality of Life


Assessing QOL


Health-related QOL is a multidimensional construct encompassing the physical, functional, emotional, and social/family well-being of an individual. Physical well-being in this context refers to symptoms related to disease (e.g., pain, nausea, and fatigue) and the side effects of treatment (e.g., limb volume change). Functional well-being includes an individual’s ability to perform activities of daily living (e.g., walking, bathing, and dressing oneself) and to perform in a societal role. Emotional well-being is a measure of coping ability and reflects the experience of feelings ranging from enjoyment to distress, and social well-being reflects the quality of relationships with family and friends, as well as wider social interactions.


Health utilities are related to, but distinct from, QOL. Health utilities assess the value assigned to specific health states by specific populations using standardized methods. One of the most commonly used health utilities is the European QOL-5 Dimensions questionnaire (EuroQol-5D), which uses preference weights from the general population and can be used to calculate quality-adjusted life years for cost-effectiveness analyses. The EQ-5D-3L is the three-level version of the EuroQol-5D that was introduced in 1990 by the EuroQoL Group. It has been used widely since then because of its easy-to-use scoring system and its availability in more than 170 languages. In the Lymphoedema Impact and Prevalence-International Lymphoedema Framework (LIMPRINT) study, a sample of 1094 patients completed the EQ-5D-3L and visual analog scale (VAS) and the Quality of Life Measure for Limb Lymphedema (LYMQOL) tools to assess health-related QOL. The EQ-5D-3L scores were positively and significantly correlated with the LYMQOL VAS ( p =0.79; p < 0.001). EQ-5D VAS and LYMQOL VAS scores were positively correlated; higher scores for one tool corresponded to higher scores for the other. The higher the LYMQOL score, the lower the QOL. The authors found that adults with chronic edema experienced a significant negative impact on health-related QOL. Adults with upper arm edema experienced a higher impact on symptom and appearance domains, while adults with lower limb edema experienced a higher impact on function and appearance.


Lymphedema and QOL


Lymphedema has been shown repeatedly to significantly affect QOL and to result in post-treatment psychosocial distress in some patients. Burckhardt et al. noted in a review of qualitative literature addressing breast cancer–related lymphedema that lymphedema led to issues in a wide range of daily activities, including impact on professional life, dependency on others for daily activities, challenges with many forms of exercise, and problematic fitting and comfort of clothing and use of compression garments.


The physical impact of lymphedema varies significantly between survivors of head and neck cancers. In this population of patients, swelling of the head and neck region can have major functional implications, such as dysphonia or an inability to swallow. In a qualitative study of 20 head and neck cancer survivors, Deng et al. reported that participants experienced both physical and psychological benefits from lymphedema therapy, including reduced swelling and increased swallowing ability. Results were often impaired by a lack of insurance coverage and ability to access lymphedema care. The authors concluded that addressing barriers to care is critical to maximizing treatment outcomes and health-related QOL.


In examining QOL outcomes in patients with lymphedema, Tidhar and Armer identified concepts indicating successful management of lymphedema. The study results revealed consistent, recurrent themes such as hope, a significant lack of understanding of and information about moving from therapist care to self-care by health professionals, increased self-management ability, and return to normal life activities. A prospective study by Salgarello et al. examined QOL outcomes in patients after lymphaticovenular anastomosis. Using the LYMQOL tool, participants demonstrated a statistically significant ( p < 0.001) improvement in limb function, overall body image, lymphedema symptoms, and mood in patients with both upper and lower limb lymphedema.


Validated Instruments


General QOL and Health Utility Tools Utilized in Lymphedema Outcome Evaluations ( Tables 25.2–25.4 )


Short Form-36 Health Survey (SF-36) from the RAND Medical Outcomes Study


The SF-36 measures physical functioning and mental health constructs in eight domains, including vitality and mental and physical function (see Table 25.2 ). The SF-36 has been used in a pilot study of the effect of weight-lifting on lower extremity lymphedema (n=10), with no significant change between beginning of weight-lifting training and completion of training. The SF-36 was used in another study to assess QOL in 60 breast cancer survivors with lymphedema. QOL was measured before and after liposuction at 1, 3, 6, and 12 months; QOL measured with the SF-36 improved in patients after combined liposuction and controlled compression therapy.



Table 25.2

Overview of Assessed Questionnaires, With Validation.

Reprinted with permission from Cornelissen AJM, Kool M, Keuter XHA, et al. Quality of life questionnaires in breast cancer-related lymphedema patients: review of the literature. Lymph Res Biol. 2018;16(2):134–139, Table 1.


























































































































Questionnaire (Abbreviation) Questionnaire (Full Name) No. of Studies Validation Author(s) Year Consistency Validity (n) Cronbach’s α Coefficients
Group 1
SF-36 Short Form 36 12 Brazier et al. 1992 1582 0.73–0.96
DASH Disabilities of Arm, Shoulder, and Hand 4 Dias et al. 2008 100 0.98
HADS Hospital Anxiety and Depression Scale 1 Bjelland et al. 2002 Review 0.67–0.93
McGill Pain score McGill Pain score 1 Melzack 1987 16 0.74–1.00
MYMOP Measure Yourself Medical Outcome Profile 1 Barbosa Lima et al. 2016 74 0.38–0.62
PANAS Positive and Negative Affect Schedule 1 Watson et al. 1988 Unknown 0.86–0.90
Group II
EORTC QLQ-C30 Quality of Life Questionnaire Core-30 12 Tan et al. 2014 170 0.85
EORTC QLQ-BR23 Quality of Life Questionnaire Breast-23 11 Sprangers et al. 1996 170 0.57–0.89
FACT-B Functional Assessment of Cancer Therapy Breast Cancer 11 Coster et al. 2001 279 0.62–0.88
Group III
Lymph-ICF Lymphedema Functioning, Disability, and Health 5 Devoogdt et al. 2011 60 >0.70
ULL 27 Upper Limb Lymphedema 27 3 Launois et al. 2002 301 0.82–0.93
LSIDS-A Lymphedema Symptom and Intensity Survey–Arm 1 Ridner & Dietrich 2015 236 0.93–0.94
LyQLI Lymphedema Quality of Life Inventory 2 Klernäs et al. 2015 126 0.87–0.92
PBI-L Patient Benefit Index–Lymphedema 1 Blome et al. 2014 65 0.80–1.00
LYMQOL Quality of Life Measure for Limb Lymphedema 1 Keeley et al. 2010 209 0.83–0.88


Table 25.3

Overview of Assessed Quality of Life Domains in the Different Questionnaires.

Reprinted with permission from Cornelissen AJM, Kool M, Keuter XHA, et al. Quality of life questionnaires in breast cancer-related lymphedema patients: review of the literature. Lymph Res Biol . 2018;16(2):134–139, Table 25.2 .


































































































































































































Questionnaire a Answer Type Physical Function Mental Function Daily Activities Hobbies and Jobs Mobility Social Activities Sexual Function
Group I
SF-36 Categories × × × ×
DASH Categories × × × × × × ×
HADS Categories ×
McGill Pain score Categories—VAS × × ×
MYMOP Categories × × ×
PANAS Categories ×
Group II
EORTC QLQ-C30 Categories × × × × × ×
EORTC QLQ-BR23 Categories × × ×
FACT-B Categories × × × × ×
Group III
Lymph-ICF VAS × × × × × ×
ULL 27 Categories × × × × × ×
LSIDS-A Categories × × × × × × ×
LyQLI Categories × × × × × × ×
PBI-L Categories × × × × × ×
LYMQOL Categories × × × × × ×

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Jun 23, 2021 | Posted by in CARDIAC SURGERY | Comments Off on Evidence-Based Assessment and Outcomes Following Lymphedema Treatment
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