Preliminary evaluation of reliability and validity of head and neck external lymphedema and fibrosis assessment criteria.

PURPOSE: Measurement of head and neck external lymphedema and fibrosis (LEF) is challenging. To address this gap, we developed the Head and Neck External Lymphedema and Fibrosis (HN-LEF) Assessment Criteria. This article aimed to report preliminary data on reliability and validity of the HN-LEF Assessment Criteria. METHODS: Sixty head and neck cancer (HNC) patients who were ≥3-month post cancer therapy were recruited. Study measures included 1) demographic/medical data; 2) LEF physical examination completed independently by two staff members for interrater reliability (intrarater reliability completed by one of them); and 3) grayscale ultrasound examination of the head and neck skin. Reliability estimates used percent agreement and Kappa statistic. Validity was assessed via Spearman correlations of physical examination findings with ultrasound measurements. RESULTS: Fifty-one out of 60 HNC patients completed both physical examination and ultrasound assessments. Interrater reliability: 91.0% agreement (Kappa = 0.81, p < 0.001) on the presence of types of LEF; 84.9% agreement regarding the grade of LEF (Kappa = 0.70, p < 0.001) across all anatomic sites. Intrarater reliability: 96.1% agreement for type of LEF; and 91.4% agreement for grade across all sites. Ultrasound examination demonstrates characteristics and patterns for different types of LEF (particularly in the cheek, submental, and neck regions). CONCLUSIONS: The study provided initial reliability and validity data for a clinician-reported tool evaluating external LEF in the HNC population. These preliminary findings demonstrate that the tool had good reliability. Associations with the ultrasound examination results demonstrate that the tool validly captures soft tissue changes at select sites. Further validation of the tool is warranted.

The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema.

IMPORTANCE: The prevalence and clinical burden of lymphedema is known to be increasing. Nevertheless, evidence-based comparative effectiveness data regarding lymphedema therapeutic interventions have been poor. OBJECTIVE: To examine the impact of an advanced pneumatic compression device (APCD) on cutaneous and other clinical outcomes and health economic costs in a representative privately insured population of lymphedema patients. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of a deidentified private insurance database from 2007 through 2013, and multivariate regression analysis comparing outcomes for the 12 months before and after APCD purchase, adjusting for baseline patient characteristics. Patients with lymphedema who received an APCD who were commercially insured and Medicare managed care enrollees from a large, national US managed care health insurer. The study population was evaluated as cancer-related and non-cancer-related lymphedema cohorts. INTERVENTION: Receipt of an APCD. MAIN OUTCOMES AND MEASURES: Rates of cellulitis, use of lymphedema-related manual therapy, outpatient hospital visits, and inpatient hospitalizations. Lymphedema-related direct costs were measured for home health care, hospital outpatient care, office visits, emergency department use, and inpatient care. RESULTS: The study sample included 718 patients (374 in the cancer cohort and 344 in the noncancer cohort). In both cohorts, use of an APCD was associated with similar reductions in adjusted rates of cellulitis episodes (from 21.1% to 4.5% in the cancer cohort and 28.8% to 7.3% in the noncancer cohort; P < .001 for both), lymphedema-related manual therapy (from 35.6% to 24.9%in the cancer cohort and 32.3% to 21.2% in the noncancer cohort; P < .001 for both), and outpatient visits (from 58.6% to 41.4% in the cancer cohort and 52.6% to 31.4% in the noncancer cohort; P < .001 for both). Among the cancer cohort, total lymphedema-related costs per patient, excluding medical equipment costs, were reduced by 37% (from $2597 to $1642, P = .002). The corresponding decline in costs for the noncancer cohort was 36% (from $2937 to $1883, P = .007). CONCLUSIONS AND RELEVANCE: The study found an association between significant reductions in episodes of cellulitis (cancer vs noncancer cohorts) and outpatient care and costs of APCD acquisition within a 1-year time frame in patients with both cancer-related and non-cancer-related lymphedema.

Assessment and measurement of head and neck lymphedema: state-of-the-science and future directions.

Currently, assessment and measurement of lymphedema in head and neck cancer patients is difficult. The aims of this report are to examine the current state of science regarding available measurement of head and neck lymphedema, to identify gaps in clinical evaluation of head and neck lymphedema, and to propose future research directions for advancing the assessment of head and neck lymphedema. The authors conducted a comprehensive literature review based on PubMed, CINAHL, Cochrane database, EMBASE, and PsycINFO from 1989 to 2014. Primary search terms included head and/or neck cancer, head and/or neck and/or face, lymphedema, edema, swelling, fibrosis, measurement, assessment, and evaluation. The authors also reviewed information from the Oncology Nursing Society, National Lymphedema Network, National Cancer Institute, American Cancer Society, and other related healthcare professional association web sites. Based on the nature/characteristics of measurement reported in the literature, methods for assessment of head and neck lymphedema can be categorized into: (1) patient-reported outcome (PRO) measures (e.g., symptom tool), (2) clinician-reported outcome (CRO) measures based on clinical grading criteria via a clinical exam (external lymphedema evaluation by physical examination and internal edema examination via endoscopy), and (3) technical capacity/measurement techniques (e.g., imaging techniques). Although a number of measures have been reported in the literature, clinically useful PRO and CRO measures, and reliable and sensitive measurement techniques need to be validated to address gaps in assessment of head and neck lymphedema, and to be easily used in early identification of lymphedema and assessment of treatment/interventional effects.

Development and preliminary testing of head and neck cancer related external lymphedema and fibrosis assessment criteria.

PURPOSE: To develop assessment criteria for evaluating and documenting status of external lymphedema and fibrosis in patients with head and neck cancer (HNC). METHODS: This was a two-phase instrument development study. In Phase I, initial assessment criteria for head and neck external lymphedema and fibrosis were generated based on a conceptual framework developed to describe the continuum of lymphedema - fibrosis in HNC patients. The initial Head and Neck External Lymphedema and Fibrosis (HN-ELAF) Assessment Criteria with three components were revised based on expert feedback. In Phase II, a pilot study was conducted to evaluate the revised assessment criteria through direct physical examination of 30 HNC patients with facial swelling and/or scar-like tissue >3 months post-treatment. The following statistical methods were used to evaluate interrater reliability in Phase II: simple percent agreement, the Kappa statistic, and the concordance correlation coefficient. Then, a post-test revision was made to further modify the tool based on the results of the pilot test. RESULTS: In Phase I, the initial HN-ELAF was revised including deleting Grade 0 (subclinical disease) and two components (i.e., symptoms and functional impairments). The revised HN-ELAF Assessment Criteria demonstrated good content/face validity. In Phase II, the assessment criteria had an acceptable interrater reliability, e.g., 83% exact agreement on grading lymphedema and fibrosis severity; and kappa = 0.75 (p < .001). The assessment criteria were further modified including three dimensions: type, severity, and anatomical sites of lymphedema and fibrosis. CONCLUSIONS: Validation of the modified HN-ELAF Assessment Criteria in larger sample sizes is ongoing.

Assessment of external lymphedema in patients with head and neck cancer: a comparison of four scales.

PURPOSE/OBJECTIVES: To compare available grading and staging scales that measure external lymphedema in patients with head and neck cancer (HNC) and to assess problems and gaps related to these tools. DESIGN: Cross-sectional. SETTING: A comprehensive cancer center in Tennessee. SAMPLE: 103 participants post-HNC treatment. METHODS: Four scales were used to evaluate study participant external lymphedema status, including the Common Terminology Criteria for Adverse Events (CTCAE) Lymphedema Scale (version 3.0), American Cancer Society Lymphedema Scale, Stages of Lymphedema (Földi's Scale), and the CTCAE Fibrosis Scale (version 3.0). MAIN RESEARCH VARIABLES: Occurrence rate, severity of lymphedema, and components and descriptors of each scale. FINDINGS: The prevalence and severity of external lymphedema differed based on the tools. Each tool had an identified limitation. Current theory postulates a continuum between lymphedema and fibrosis, but only the Földi's Scale adequately reflected that concept. CONCLUSIONS: None of the available scales clearly captured all the important characteristics of external lymphedema in patients with HNC. A need exists to develop a clearly defined and validated scale of external lymphedema in the HNC population. IMPLICATIONS FOR NURSING: Oncology nurses should take an active role in addressing issues related to lymphedema assessment in patients post-HNC treatment; however, new assessment tools need to be developed for clinical use. KNOWLEDGE TRANSLATION: Early identification and accurate documentation of head and neck lymphedema are critically important to prevent lymphedema progress. However, existing grading criteria failed to capture important characteristics of external head and neck lymphedema. More research efforts need to be made to address this under-recognized issue.

Psychosocial impact of lymphedema: a systematic review of literature from 2004 to 2011.

OBJECTIVE: This systematic review aimed to evaluate the level of evidence of contemporary peer-reviewed literature published from 2004 to 2011 on the psychosocial impact of lymphedema. METHODS: Eleven electronic databases were searched and 1311 articles retrieved; 23 met inclusion criteria. Twelve articles utilized qualitative methodology and 11 used quantitative methodology. An established quality assessment tool was used to assess the quality of the included studies. RESULTS: The overall quality of the 23 included studies was adequate. A critical limitation of current literature is the lack of conceptual or operational definitions for the concept of psychosocial impact. Quantitative studies showed statistically significant poorer social well-being in persons with lymphedema, including perceptions related to body image, appearance, sexuality, and social barriers. No statistically significant differences were found between persons with and without lymphedema in the domains of emotional well-being (happy or sad) and psychological distress (depression and anxiety). All 12 of the qualitative studies consistently described negative psychological impact (negative self-identity, emotional disturbance, and psychological distress) and negative social impact (marginalization, financial burden, perceived diminished sexuality, social isolation, perceived social abandonment, public insensitivity, and non-supportive work environment). Factors associated with psychosocial impact were also identified. CONCLUSIONS: Lymphedema has a negative psychosocial impact on affected individuals. The current review sheds light on the conceptualization and operationalization of the definitions of psychosocial impact with respect to lymphedema. Development of a lymphedema-specific instrument is needed to better characterize the impact of lymphedema and to examine the factors contributing to these outcomes in cancer and non-cancer-related populations.

Preliminary development of a lymphedema symptom assessment scale for patients with head and neck cancer.

PURPOSE: Currently, no instruments are available to assess symptoms secondary to lymphedema in patients with head and neck cancer (HNC). The study aim was to develop and conduct preliminary tests of such an instrument. METHODS: A preliminary item pool was generated from a literature review, previous work in breast cancer-related lymphedema, and an observational study. The item pool was revised based on an expert panel's suggestions and feedback from 18 patients with HNC. The current questionnaire, the Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-H&N), was then pilot tested in 30 patients with HNC. RESULTS: Preliminary testing (1) demonstrated feasibility, readability, and ease of use of the LSIDS-H&N and (2) identified that there was a considerable level of symptom burden in the cohort of patients in the piloting sample. CONCLUSION: Content validity of the LSIDS-H&N was supported by the expert panel during development of the LSIDS-H&N. Further testing is ongoing.

Vanderbilt Head and Neck Symptom Survey version 2.0: report of the development and initial testing of a subscale for assessment of oral health.

BACKGROUND: The prevalence, severity, and functional implications of adverse oral health outcomes attributed to head and neck cancer therapy are largely undefined. We report development of an oral health outcome subscale for the Vanderbilt Head and Neck Symptom Survey (VHNSS). METHODS: Oral health outcome questions were formulated through literature review and consultation with an expert panel. Questions were incorporated into the VHNSS resulting in a 50-item survey, scored 0 (none) to 10 (severe). The tool was administered to 70 subjects who completed radiation to assess for feasibility. RESULTS: Patient acceptance was high with a completion time <10 minutes. A full range of scores was noted for 46 of 50 questions. Oral health symptom burden was high early and late posttreatment. CONCLUSIONS: The VHNSS version 2.0 was feasible and could be completed in a timely manner. Validation studies are ongoing. The high prevalence of adverse oral health outcomes warrants further study.

Reliability and validity of the Vanderbilt Head and Neck Symptom Survey: a tool to assess symptom burden in patients treated with chemoradiation.

BACKGROUND: We describe the development and validation of the Vanderbilt Head and Neck Symptom Survey (VHNSS), which was designed to screen for tumor- and treatment-specific symptoms in patients with head and neck cancer undergoing concurrent chemoradiation (CCR). METHODS: Using a 2-step card sort method, we identified high-impact and high-frequency toxicities in patients with head and neck cancer treated with CCR. This resulted in a 28-item questionnaire which scores symptoms on a 0 to 10 scale (none to severe). The tool was validated using data collected from 5 supportive care studies comprising a total sample of 332 patients with head and neck cancer. RESULTS: Responses to the VHNSS items demonstrated a very consistent pattern (Cronbach's alpha = 0.943) with each item contributing substantially to the global index. Five symptom subscales were identified including "Nutrition," "Pain," "Voice," "Swallow," and "Mucous/Dry Mouth." Each of the cluster scores demonstrated good internal consistency. The pattern of associations between the VHNSS and established tools indicated appropriate convergence and divergence. Comparison of global and subscale scores and objective measure were also in the expected direction providing further evidence of validity. CONCLUSIONS: The findings provide support that the VHNSS is a valid and reliable tool to assess head and neck-specific symptom burden and function loss. Further research to evaluate this screening tool as a part of a systems approach to supportive care is warranted.

Incidence, treatment costs, and complications of lymphedema after breast cancer among women of working age: a 2-year follow-up study.

PURPOSE: This study estimated the economic burden of breast cancer-related lymphedema (BCRL) among working-age women, the incidence of lymphedema, and associated risk factors. METHODS: We used claims data to study an incident cohort of breast cancer patients for the 2 years after the initiation of cancer treatment. A logistic regression model was used to ascertain factors associated with lymphedema. We compared the medical costs and rate of infections likely associated with lymphedema between a woman with BCRL and a matched control. We performed nonparametric bootstrapping to compare the unadjusted cost differences and estimated the adjusted cost differences in regression analysis. RESULTS: Approximately 10% of the 1,877 patients had claims indicating treatment of lymphedema. Predictors included treatment with full axillary node dissection (odds ratio [OR] = 6.3, P < .001) and chemotherapy (OR = 1.6, P = .01). A geographic variation was observed; women who resided in the West were more likely to have lymphedema claims than those in the Northeast (OR = 2.05, P = .01). The matched cohort analysis demonstrated that the BCRL group had significantly higher medical costs ($14,877 to $23,167) and was twice as likely to have lymphangitis or cellulitis (OR = 2.02, P = .009). Outpatient care, especially mental health services, diagnostic imaging, and visits with moderate or high complexity, accounted for the majority of the difference. CONCLUSION: Although the use of claims data may underestimate the true incidence of lymphedema, women with BCRL had a greater risk of infections and incurred higher medical costs. The substantial costs documented here suggest that further efforts should be made to elucidate reduction and prevention strategies for BCRL.