Longitudinal evaluation of the oral mucositis weekly questionnaire-head and neck cancer, a patient-reported outcomes questionnaire

BACKGROUND: Quality-of-life instruments that measure specific functional consequences of mucositis are needed to assess the efficacy of therapeutic interventions targeted against mucositis and to guide patient care. The authors undertook a prospective, multicenter, observational study to assess the validity, reliability, and feasibility of a new instrument, the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN). The OMWQ-HN is a patient-reported outcome questionnaire that measures the symptoms of mucositis, including mouth and throat soreness (MTS), and their impact on patient well-being and function. METHODS: The OMWQ-HN, along with the Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN), was administered 5 times over an approximately 6-week period to patients with head and neck cancer (HNC) who were receiving radiation therapy with or without chemotherapy. Information on supportive care measures also was collected. RESULTS: Seventy-five patients were enrolled and completed 93% of scheduled assessments (100% at baseline). The OMWQ-HN demonstrated good test-retest reliability (correlation coefficient, 0.80-0.89). Cross-sectional analyses to assess validity showed that OMWQ-HN scores were different across levels of pain, with those in the worst pain category reporting the highest OMWQ-HN scores. Strong correlations were observed between OMWQ-HN and FACT-HN. Patients experienced increases in MTS, which corresponded with a steady decline in function. MTS scores were highest in the patients who were taking opioid analgesics, suggesting that mucositis pain continued despite standard pain therapy. CONCLUSIONS: The current results indicated that the OMWQ-HN is a valid, reliable, and feasible instrument for assessing the impact of mucositis on patients who are receiving radiation therapy with or without chemotherapy for HNC.     

Improving patient outcomes through the routine use of patient‐reported data in cancer clinics: future directions

Objectives: Recent reviews suggest that the routine use of patient‐reported outcome measures (PROMs) in cancer clinics improves the processes of care but not patient outcomes such as quality of life or satisfaction. We set out to identify future strategies for (1) interventions to impact patient outcomes and (2) trials to identify treatment effects. Methods: MEDLINE and PsycINFO were systematically searched to identify reports of relevant randomized controlled trials. Intervention and trial designs were compared and contrasted along the parameters identified by previous reviews and the rationales reported in each article. Results were cross‐referenced with evidence for impact to develop recommendations. Results: Six articles were identified. Evidence for impact on patient outcomes was limited. Interventions varied according to the PROMs used, the frequency, content and presentation of feedback, and the training offered to medical teams. Trials varied in their unit of randomization, outcome measures, control of contamination, monitoring of PROM use, and length of follow‐up. Our analysis identified the need for future interventions to ensure that PROM data are used to optimum effect and for trials to control for contamination and monitor use of PROMs to link this with outcomes. Conclusions: Future interventions should motivate and equip health professionals to use PROM data in managing patients, train patients in self‐efficacy, use more specific PROMs in clinic, improve the interpretability of feedback for both medical staff and patients, and monitor the use of PROMs to intervene when problems arise. Future trials should use a cluster‐randomized design to control for contamination and enable systems‐based interventions. Copyright © 2009 John Wiley & Sons, Ltd.     

Patient-reported measurements of oral mucositis in head and neck cancer patients treated with radiotherapy with or without chemotherapy: demonstration of increased frequency, severity, resistance to palliation, and impact on quality of life

BACKGROUND.

The risk, severity, and patient‐reported outcomes of radiation‐induced mucositis among head and neck cancer patients were prospectively estimated.

METHODS.

A validated, patient‐reported questionnaire (OMDQ), the FACT quality of life (QOL), and the Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scales were used to measure mucositis (reported as mouth and throat soreness), daily functioning, and use of analgesics. Patients were studied before radiotherapy (RT), daily during RT, and for 4 weeks after RT.

RESULTS.

Contrary to previous reports, the risk of mucositis was virtually identical in the 126 patients with oral cavity or oropharynx tumors (99% overall; 85% grade 3‐4) compared with 65 patients with tumors of the larynx or hypopharynx (98% overall; 77% grade 3‐4). The mean QOL score decreased significantly during RT, from 85.1 at baseline to 69.0 at Week 6, corresponding with the peak of mucositis severity. The mean functional status score decreased by 33% from 18.3 at baseline to 12.3 at Week 6. The impact of mucositis on QOL was proportional to its severity, although even a score of 1 or 2 (mild or moderate) was associated with a significant reduction in QOL (from 93.6 at baseline to 74.7 at Week 6). Despite increases in analgesic use from 34% at baseline to 80% at Week 6, mean mucositis scores exceeded 2.5 at Week 6.

CONCLUSIONS.

Mucositis occurs among virtually all patients who are undergoing radiation treatment of head and neck cancers. The detrimental effects on QOL and functional status are significant, and opioid analgesia provides inadequate relief. Preventive rather than symptom palliation measures are needed. Cancer 2008. © 2008 American Cancer Society.     

Efficient assessment of the most important symptoms in advanced prostate cancer: the NCCN/FACT‐P Symptom Index

Background: Owing to the spectrum of symptoms, side effects, and concerns in clinically advanced prostate cancer (PC), effective symptom assessment is imperative. In line with recent regulatory guidance on the development of patient‐reported outcomes, we undertook a multistep/multistudy approach to develop and test a new symptom index (NCCN FACT‐Prostate Symptom Index‐17 that can be used to examine the effectiveness of noncurative treatments in advanced PC. Methods: This included significant input from two waves of expert medical providers (n=66 and 11, respectively) and two waves of patient engagement and testing (n=50 and 24, respectively). The resulting 17‐item symptom index for advanced PC was then divided into sets or categories based on whether the symptoms are predominantly disease or treatment related. Results: Preliminary reliability estimates suggest good internal consistency (α=0.86) and relationships with expected outside validity criteria are moderate to strong. Conclusions: This new tool may help clinicians and researchers quickly target and measure important symptoms and concerns in advanced PC, leading to increased knowledge of treatment effectiveness of noncurative therapies and improvements in the quality of patient care. Copyright © 2010 John Wiley & Sons, Ltd.