RESUMEN
PURPOSE: Cancer-related fatigue (CRF) is a common and debilitating consequence of cancer and its treatment. Numerous supportive care interventions have been developed to alleviate CRF; however, the diversity of outcome measures used to assess CRF limits comparability of findings. We aimed to evaluate the content and psychometric properties of measures used to assess CRF in interventions targeting fatigue, to inform the selection of suitable measures in future research. METHODS: Included measures were identified from a systematic review of interventions targeting CRF. General characteristics of each measure were extracted, and item content was assessed against domains specified by the National Comprehensive Cancer Network (NCCN) definition of CRF. Psychometric properties were evaluated against COnsensus-based Standards for the selection of heath Measurement INstruments (COSMIN) criteria. RESULTS: Of 54 measures identified, 25 met inclusion criteria. Seventeen were fatigue-specific and eight a fatigue subscale or single item within a broader measure. Only 14 (56%) were specifically developed for cancer populations. Content coverage according to the NCCN CRF definition ranged from 0 to 75%. Evidence for fulfilment of COSMIN criteria in cancer populations ranged from 0 to 93%, with only five measures meeting > 70% of the COSMIN criteria. CONCLUSION: The Piper Fatigue Scale-Revised had good content coverage, but did not comprehensively address COSMIN criteria. The EORTC-FA12 and FACIT/FACT-F had excellent psychometric properties, with each capturing different aspects of fatigue. Ultimately, the choice of CRF measure should be guided by the research question and the CRF domains most relevant to the particular research context.
Asunto(s)
Fatiga , Neoplasias , Humanos , Consenso , Recolección de Datos , Fatiga/diagnóstico , Fatiga/etiología , Fatiga/terapia , Neoplasias/complicaciones , Psicometría , Reproducibilidad de los ResultadosRESUMEN
In the original publication of the article, the sentence "The ANZCTR is the fifth largest trial registry internationally, with 21,330 registered trials as at January 2018 [5]" in the Introduction section was published incorrectly.
RESUMEN
AIMS: It is important to understand the number, types and regions of trials that include patient-reported outcomes (PROs) to appreciate how patient experiences have been considered in studies of health and interventions. Twenty-seven percent of trials registered with ClinicalTrials.gov (2007-2013) included PROs; however, a regional breakdown was not provided and no reviews have been conducted of the Australia New Zealand Clinical Trials Registry (ANZCTR). We aimed to identify trials registered with ANZCTR with PRO endpoints and describe their characteristics. METHODS: ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with PRO endpoints. Search terms included PRO measures listed in Patient-Reported Outcomes Quality of Life Instrument Database and Grid-Enabled Measures, as well as generic PRO terms (e.g. "quality of life" (QOL)). Trial endpoints were individually coded using an established framework to identify trials with PROs for the analysis. RESULTS: Of 13,666 registered trials, 6168 (45.1%) included a PRO. The proportion of studies including PROs increased between 2006 and 2016 (r = 0.74, p = 0.009). Among the 6168 trials, there were 17,961 individual PRO endpoints, including symptoms/functional outcomes/condition-specific QOL (65.6%), generic QOL (13.2%), patient-reported experiences (9.9%), patient-reported behaviours (7.9%). Mental health was the most common category (99.8% included PROs), followed by physical medicine/rehabilitation (65.6%), musculoskeletal (63.5%), public health (63.1%), and cancer (54.2%). DISCUSSION: Our findings suggest growing use of PROs in the assessment of health and interventions in ANZ. Our review identifies trial categories with limited patient-reported information and provides a basis for future work on the impact of PRO findings in clinical care.
