Development of a patient-reported questionnaire for collecting toxicity data following prostate brachytherapy.
ABSTRACT To improve a questionnaire used to collect patient-reported outcomes from patients with early stage prostate cancer treated with brachytherapy. A secondary aim was to adapt the Late Effects of Normal Tissue (LENT) subjective toxicity questionnaire for use to collect Common Terminology Criteria for Adverse Events (CTCAE) data, the current preferred platform for assessing radiation toxicity.
Three hundred and seventy-seven patients were treated with permanent iodine-125 seed implant brachytherapy for early prostate cancer. Toxicity data were collected before and at nine time points post-treatment (0-36 months). Compliance rates for patients completing individual items and item-subsection correlation coefficients were calculated. A factor analysis was carried out to analyse responses to the questionnaire and identify less informative questions, which could be removed. Cronbach's α coefficient was used to measure reliability.
Two thousand one hundred and eighty-eight questionnaires were analysed. There was poor compliance for questions specifically relating to operations and bowel medication. We found that the division of the questionnaire into subsections based on anatomical site was reasonable and that certain items could be safely removed. The high mean value for Cronbach's α across all questionnaires (0.752; 95% CI: 0.726-0.779) indicated that the questionnaire was reliable. Fifteen of the 44 questions were removed from the original questionnaires. Questions on urinary incontinence severity, management of urinary and bowel incontinence, effects of reduced flow of urine and the effects of symptoms on activity of daily living and change in sexual function were required to adapt the LENT subjective questionnaire for use to collect CTCAE data.
A questionnaire, validated over 6 years to collect LENT subjective data were adapted and is a reliable approach for collecting CTCAE data after prostate brachytherapy.
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ABSTRACT: The impact of the dose to the urethra and sources placed close to the urethra on urinary morbidity after permanent prostate brachytherapy (PPB) is not well known. Fifty-nine patients were surveyed prospectively before treatment (A), 1 month after (B) and > 1 year after PPB (C) using a validated questionnaire (Expanded Prostate Cancer Index Composite). Computed tomography (CT) postimplant scans were performed at days 1 (Foley catheter in situ) and 30 after PPB and sources within 5mm of the urethra at day 1 were identified. As opposed to the urethral dose-volume histogram, a larger number of sources within 5mm of the urethra at day 1 predicted significantly larger urinary bother score changes at times B and C - with an impact on incontinence and frequency (e.g. moderate/big problem with leaking urine in 25% vs. 3%, p = 0.02; moderate/big problem with frequent urination in 33% vs. 7%, p < 0.01, at time C with vs. without ≥ 3 sources in a single strand placed close to the urethra). Placement of sources with a minimum distance of a few mm to the urethra should be a major aim to avoid urinary morbidity irrespective of the urethral dose-volume histogram.Radiotherapy and Oncology 01/2012; 103(2):247-51. · 4.52 Impact Factor
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ABSTRACT: It is critical for prostate cancer researchers and clinicians to have access to comprehensive, sensitive and simple-to-use symptom measures that allow them to understand and quantify the subjective patient experience. The purpose of the current review is to provide a comprehensive review, detailed tool descriptions and objectively defined quality criteria to facilitate tool choices for patients with localized prostate cancer. Using a systematic web-based literature search, we found n=29 prostate symptom measures described in n=35 validation studies. To be recommended, tools needed to meet four criteria: broad domain coverage, ability to differentiate objective and subjective experience, good internal consistency and validation in at least two populations and/or having achieved two types of validations. Of the 29 tools reviewed, n=7 meet our criteria for recommendation, and three in particular (the EPIC-26 (Expanded Prostate Cancer Index Composite)-26, PC-QOL (Prostate Cancer-Quality of Life) and the UCLA-PCI (UCLA Prostate Cancer Index)) showed the strongest psychometrics. There is a reasonable number of measures to choose from that meet criteria for good psychometrics.Prostate Cancer and Prostatic Disease advance online publication, 5 February 2013; doi:10.1038/pcan.2013.1.Prostate cancer and prostatic diseases 02/2013; · 2.10 Impact Factor
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ABSTRACT: Background. The Late Effects Normal Tissue/Subjective Objective Management Analytic (LENT/SOMA) system for grading of side effects after radiotherapy was proposed several years ago. Only a few studies have previously been performed on the validity of the LENT/SOMA. The aim of the present study was to validate the LENT/SOMA scoring system for recto-anal side effects after treatment for prostate cancer in a randomized trial. Material and methods. A total of 875 patients with locally advanced prostate cancer were randomized to either hormonal treatment alone or hormonal treatment plus radiotherapy in the Scandinavian Prostate Cancer Group 7 (SPCG-7) study. At least three years after treatment was started, the 178 patients that were randomized at St. Olavs Hospital were approached. One hundred and three patients of these accepted inclusion. The side effects according to LENT/SOMA were graded by oncologist and nurse. In addition, side effects were graded according to the European Organisation for Research and Treatment of Cancer and the Radiation Therapy Oncology Group (EORTC/RTOG) toxicity scale and patient-reported health-related quality of life (HRQOL) questionnaires. Content/face validity, sensitivity and inter-rater reliability of the LENT/SOMA tables for rectum were analyzed. Results. Content/face analysis of LENT/SOMA revealed serious problems. Significant correlations (Spearman's rho > 0.4) were found between three of 15 LENT/SOMA items and similar HRQOL items. LENT/SOMA score made it possible to detect significant differences between the two groups of patients (p < 0.001), EORTC/RTOG toxicity score did not (p = 0.138). Inter-rater reliability was acceptable. Conclusions. LENT/SOMA scoring system for recto-anal side effects after radiotherapy for prostate cancer displays serious difficulties in the present study. Replacement of LENT/SOMA tables for rectum by a combination of patient-reported HRQOL questionnaires, clinical examination and objective physiological measurements might be called for.Acta oncologica (Stockholm, Sweden) 02/2013; · 2.27 Impact Factor