The ALERT-B questionnaire: A screening tool for the detection of gastroenterological late effects after radiotherapy for prostate cancer

Abstract

There is an increasing need to measure treatment-related side effects in normal tissues following cancer therapy. The ALERT-B (Assessment of Late Effects of RadioTherapy-Bowel) questionnaire is a screening tool that is composed of four items related specifically to bowel symptoms. Those patients that respond with a ''yes" to any of these items are referred on to gastroenterologist in order to improve the long-term consequences of these side effects of radiological treatment. Here we wish to test the ability of this questionnaire to identify these subsequent gastroenterological complications by tracking prostate cancer patients that were positive with respect to ALERT-B. We also carry out receiver-operator curve (ROC) analysis for baseline data for an overall ALERT-B questionnaire score with respect to subscale data for the Gastrointestinal Symptom Rating Scale (GSRS) and the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. 84.4% and 95.7% of patients identified by the ALERT-B questionnaire demonstrated complications diagnosed at 6 and 12 months post-treatment, respectively. ROC curve analysis of baseline data showed that ALERT-B detected clinically relevant levels of side effects established at baseline by the GSRS diarrhoea subscale (AUC = 0.867, 95% CI = 0.795 to 0.926) and at the minimally important level of side effects for the EPIC bowel subscale (AUC = 0.765, 95% CI = 0.617 to 0.913). These results show that ALERT-B provides a simple and effective screening tool for identifying gastroenterological complications after treatment for prostate cancer.

A proposed tailored investigational algorithm for women treated for gynaecological cancer with long-term gastrointestinal consequences

“…There is a need for earlier identification of patients requiring intervention. One way to do this is by developing assessment measures such as the ALERT-B questionnaire validated for use in oncology follow-up clinics in patients with prostate cancer who may benefit from further assessment [21]. After excluding disease progression, the next logical step would be for the oncology team to initiate first-line investigations to identify treatable symptoms.…”

Patient-reported outcome measurement implementation in cancer survivors: a systematic review

“…Of the 29 studies, 5 were randomized studies [19][20][21][22][23] and the remaining were non-randomized [24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40] (Table 1). All 5 randomized studies evaluated QoL.…”

“…25,27,29,[33][34][35]37,[40][41][42][43][44][45][46] Twenty-four studies were conducted in cancer survivors only (N=24), [19][20][21][22][23][24][27][28][29][31][32][33][35][36][37][38][39][41][42][43][44][45][46][47] while the remaining (N=5) were conducted in a mixed sample of cancer survivors, patients on active treatment, and/or parents of childhood survivors. 25,26,30,34,40 The most common malignancies were breast (N=13) 21,22,24,25,27,31,32,…”

“…Both novel and previously validated PROMs were utilized. Eighteen of the studies evaluated multiple PRO domains, 19-10 23,27,29,32,34,35,37,39-43,45,47 10 studies evaluated a single PRO domain, [24][25][26]28,30,33,36,38,44,46 and 1 study that was a conference proceeding did not report which PRO domains were assessed. 31 Of the 10 studies evaluating a single PRO domain, 7 evaluated symptom severity alone, 24,25,28,30,33,38,44 followed by 2 of sexual functioning 36,46 and 1 of health-related QoL.…”

“…Eighteen of the studies evaluated multiple PRO domains, 19-10 23,27,29,32,34,35,37,39-43,45,47 10 studies evaluated a single PRO domain, [24][25][26]28,30,33,36,38,44,46 and 1 study that was a conference proceeding did not report which PRO domains were assessed. 31 Of the 10 studies evaluating a single PRO domain, 7 evaluated symptom severity alone, 24,25,28,30,33,38,44 followed by 2 of sexual functioning 36,46 and 1 of health-related QoL. 26 Multiple PROM delivery methods were reported in the studies: 15 administered PROMs electronically, 20,21,37,[42][43][44]46,[23][24][25][26][27]30,31,34 7 administered PROMs via telephone and/or in-person, 19,28,29,35,36,40,41 6 did not report method of PROM delivery, 22,…”