International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15.

PURPOSE: This international EORTC validation study (phase IV) is aimed at testing the psychometric properties of a quality of life (QoL) module related to oral health problems in cancer patients. METHODS: The phase III module comprised 17 items with four hypothesized multi-item scales and three single items. In phase IV, patients with mixed cancers, in different treatment phases from 10 countries completed the EORTC QLQ-C30, the QLQ-OH module, and a debriefing interview. The hypothesized structure was tested using combinations of classical test theory and item response theory, following EORTC guidelines. Test-retest assessments and responsiveness to change analysis (RCA) were performed after 2 weeks. RESULTS: Five hundred seventy-two patients (median age 60.3, 54 % females) were analyzed. Completion took <10 min for 84 %, 40 % expressed satisfaction that these issues were addressed. Analyses suggested a revision of the phase III hypothesized scale structure. Two items were deleted based on a high degree of item misfit, together with negative patient feedback. The remaining 15 items formed one eight-item scale named OH-QoL score, a two-item information scale, a two-item scale regarding dentures, and three single items (sticky saliva/mouth soreness/sensitivity to food/drink). Face and convergent validity and internal consistency were confirmed. Test-retest reliability (n = 60) was demonstrated as was RCA for patients undergoing chemotherapy (n = 117; p = 0.06). The resulting QLQ-OH15 discriminated between clinically distinct patient groups, e.g., low performance status vs. higher (p < 000.1), and head-and-neck cancer versus other cancers (p < 0.03). CONCLUSION: The EORTC module QLQ-OH15 is a short, well-accepted assessment tool focusing on oral problems and QoL to improve clinical management. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01724333.

The importance of adequate primary tumor excision margins and sentinel node biopsy in achieving optimal locoregional control for patients with thick primary melanomas.

OBJECTIVE: This study sought to investigate the impact of histopathologically measured excision margins and SNB on local and locoregional disease control in patients with primary cutaneous melanomas more than 4 mm thick. BACKGROUND: Most current guidelines recommend at least a 2-cm surgical margin (which corresponds to a 16-mm histopathologic margin). These guidelines are based on limited evidence, mostly obtained in patients who did not have an SNB. METHODS: Histopathologic tumor excision margins for clinically lymph node-negative patients with melanomas more than 4 mm thick, treated at Melanoma Institute Australia (1992-2009), were determined. Clinicopathologic predictors of local and locoregional disease-free survival were investigated. RESULTS: There were 632 patients eligible for the study; of these, 397 (62.8%) had an SNB. The median histopathologic excision margin was 15 mm (interquartile range, 11.0-19.5 mm). After a median follow-up of 37 months, local and locoregional recurrences were observed in 48 (7.6%) and 159 (25.2%) patients, respectively. Excision margin as a continuous variable was a significant predictor of local [hazard ratio (HR), 0.91; P < 0.001) and locoregional (HR, 0.97; P = 0.042) tumor control on multivariate analyses. Patients with histopathologic margins 16 mm or less had worse local disease-free survival (HR, 2.41; P = 0.01). Patients who did not have an SNB were at higher risk of locoregional recurrence (HR, 1.67; P = 0.003). CONCLUSIONS: Histopathologically determined primary tumor excision margins more than 16 mm, corresponding to 2-cm surgical margins, were associated with better local control in patients with melanomas more than 4 mm thick. Patients achieved the best local and locoregional control when SNB was coupled with a more than 16-mm histologic excision margin.

Sentinel node positive melanoma patients: prediction and prognostic significance of nonsentinel node metastases and development of a survival tree model.

BACKGROUND: Completion lymph node dissection (CLND) following positive sentinel node biopsy (SNB) for melanoma detects additional nonsentinel node (NSN) metastases in approximately 20% of cases. This study aimed to establish whether NSN status can be predicted, to determine its effect on survival, and to develop survival tree models for the sentinel node (SN) positive population. MATERIALS AND METHODS: Sydney Melanoma Unit (SMU) patients with at least 1 positive SN, meeting inclusion criteria and treated between October 1992 and June 2005, were identified from the Unit database. Survival characteristics, potential predictors of survival, and NSN status were assessed using the Kaplan-Meier method, Cox regression model, and logistic regression analyses, respectively. Classification tree analysis was performed to identify groups with distinctly different survival characteristics. RESULTS: A total of 323 SN-positive melanoma patients met the inclusion criteria. On multivariate analysis, age, gender, primary tumor thickness, mitotic rate, number of positive NSNs, or total number of positive nodes were statistically significant predictors of survival. NSN metastasis, found at CLND in 19% of patients, was only predicted to a statistically significant degree by ulceration. Multivariate analyses demonstrated that survival was more closely related to number of positive NSNs than total number of positive nodes. Classification tree analysis revealed 4 prognostically distinct survival groups. CONCLUSIONS: Patients with NSN metastases could not be reliably identified prior to CLND. Prognosis following CLND was more closely related to number of positive NSNs than total number of positive nodes. Classification tree analysis defined distinctly different survival groups more accurately than use of single-factor analysis.

Cross-cultural development of a quality-of-life measure for patients with melanoma: phase 3 testing of an EORTC Melanoma Module.

Melanoma is an increasingly common skin cancer worldwide. Recent treatment advances have provided patients and healthcare professionals (HCPs) with choices where quality of life (QoL) and toxicity are important considerations. A melanoma-specific QoL questionnaire is being developed in a cross-cultural setting using a four phase process developed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group. In phase 1, a literature search identified a list of pertinent QoL issues; this was shown to HCPs and patients in eight countries and rated for importance and relevance. Questions were constructed for the highest-rated issues (phase 2) and piloted in another patient sample (phase 3). Using EORTC Quality of Life Group criteria and sequential use of factor and Rasch analysis, scales were hypothesized for field testing (phase 4). Seven QoL domains (disease symptoms, treatment issues, financial issues, access/quality of information, satisfaction with care, psychosocial issues and support), comprising 73 QoL issues, were rated by 46 HCPs and 78 patients. Fifty-six issues were rephrased as questions and piloted with 132 patients. A 38-item questionnaire (QLQ-MEL38) is available for field testing in conjunction with the EORTC QLQ-C30. This study has shown that melanoma patients have important QoL issues that have been incorporated into a new cross-culturally validated instrument. Future testing of this EORTC module is planned and will be an important step forward in providing reliable QoL data to aid future decision-making in the management and clinical trials of this complex group of patients.

The FACT-Melanoma quality-of-life instrument: comparison of a five-point and four-point response scale using the Rasch measurement model.

The FACT-Melanoma (FACT-M) is one of only two validated quality-of-life instruments designed specifically for use in patients with melanoma. The instrument incorporates FACT-G, followed by a set of questionnaire items that are specific to melanoma; all items are scored on a five-point response scale. The primary aim of this study was to evaluate the five-point response format of the FACT-M for goodness of fit to the Rasch measurement model, and to investigate whether rescoring the instrument using a four-point response format improved the psychometric properties. Two data sets of similar patient sample sizes (n=127 and 123) were used to test the reliability and validity of the generic instrument (FACT-G) to measure quality of life for patients with melanoma. The Additional Concerns and Melanoma Surgery subscales were subjected to a more detailed analysis using a combination of confirmatory factor analysis and Rasch analysis techniques. The Rasch model fit of the FACT-M was improved by the use of a four-point response format, together with the deletion of three items. Principal components analysis suggested that two melanoma-specific subscales existed within the Additional Concerns subscale and each could be reduced to seven items, respectively, with improved goodness of fit to the Rasch model. The FACT-M instrument showed improved fit to the Rasch model specifications when the items adopted a four-point response format. These results point to possible improvements in the content and structure of the FACT-M for use in future melanoma clinical trials. However, further study should be conducted with larger samples, selected by disease and treatment status.

What are the pertinent quality-of-life issues for melanoma cancer patients? Aiming for the development of a new module to accompany the EORTC core questionnaire.

Melanoma is the most serious type of skin cancer. However, there is a paucity of evidence on the impact of melanoma on the quality of life (QoL) of patients. Only two clinically validated QoL instruments have been reported in the literature. The present study has identified contemporary QoL issues during a time of great change for melanoma treatment, as a precursor to an international study to develop a new melanoma-specific QoL instrument. Twenty-two melanoma patients (American Joint Committee on Cancer stages I-IV) and 10 close family members were recruited from a metropolitan tertiary referral clinical and research centre in Sydney, Australia, to participate in interview or focus group discussions. Verbatim transcripts of these recorded interviews were systematically analysed. Seventy-three issues across seven health-related QoL domains were identified. Issues across three domains featured highly; psychosocial, availability of support and information. Given the current rapid evolution of systemic therapies for melanoma, the challenges associated with treatment choices and clinical trial participation were also highlighted in this sample. Although some issues were generic in nature, experienced by many cancer patients, this study revealed that the wide range and intensity of QoL issues reported by melanoma patients are not adequately evaluated in current QoL instruments. With the increasing importance of patient reported outcome measurement, this list has been transformed into questionnaire items, in collaboration with the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Group, for testing a new melanoma-specific QoL module for use with the EORTC core questionnaire (QLQ-C30).

Severe traumatic brain injury in New South Wales: comparable outcomes for rural and urban residents.

OBJECTIVE: To compare differences in functional outcomes between urban and rural patients with traumatic brain injury (TBI). DESIGN: A longitudinal, prospective, multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program (BIRP) for New South Wales, with follow-up at 18 months after injury. PARTICIPANTS: 198 patients (147 urban, 51 rural) with severe TBI from the 11 participating rehabilitation units. MAIN OUTCOME MEASURES: Demographic and injury details collected prospectively using a standardised questionnaire, and measures from five validated instruments (Disability Rating Scale, Mayo-Portland Adaptability Inventory, Sydney Psychosocial Reintegration Scale, Medical Outcomes Study Short Form and the General Health Questionnaire--28-item version) administered at follow-up to document functional, psychosocial, emotional and vocational outcomes. RESULTS: Demographic details, injury severity, lengths of stay in intensive and acute care wards were similar for both rural and urban groups. There were no significant group differences in functional outcomes, including return to work, at follow-up. CONCLUSIONS: Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents, and suggest that the integrated network of inpatient, outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live.