Quality Of Life Questionnaire Module Research Articles

Severe Reflux and Symptoms of Anxiety and Depression After Esophageal Cancer Surgery.

Approximately 30% of patients suffer from severe reflux after surgery for esophageal cancer, which may serve as a continuous reminder of the cancer and catalyze fear of recurrence. The aim of this study was to investigate the association between severe reflux and symptoms of anxiety and depression after esophageal cancer surgery. This was a nationwide prospective cohort study including all Swedish patients who underwent esophageal cancer surgery between 2013 and 2018. Patients reported reflux on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for gastroesophageal symptoms and psychological distress on the Hospital Anxiety and Depression Scale at 1 and 2 years after surgery. Repeated-measures logistic regression was used to calculate odds ratios (ORs) with 95% confidence intervals (CIs), adjusted for age, sex, comorbidity, body mass index, TNM classification, neoadjuvant therapy, surgery type, postoperative complications, antireflux medication, and elevated headrest at night. Among 154 included patients, 43 (28%) and 37 (24%) reported severe reflux 1 and 2 years after surgery, respectively. No association between severe reflux and anxiety (OR, 2.1; 95% CI, 0.7-6.3) or depression (OR, 1.2; 95% CI, 0.3-4.6) was found 1 year after surgery. After 2 years, there was still no association between severe reflux and anxiety (OR, 0.9; 95% CI, 0.3-2.8) or depression (OR, 1.2; 95% CI, 0.5-3.3). Findings suggest that severe reflux is not associated with anxiety or depression after esophageal cancer surgery. For esophageal cancer survivors, other factors than severe reflux may be more important for the psychological recovery.

Prediction of severe reflux after oesophageal cancer surgery

IntroductionA common and burdensome consequence of oesophagectomy for cancer is reflux. This study aimed to develop a risk prediction model for postoperative reflux using variables available at the time of surgery enabling tailored preventive symptom management. MethodsData were obtained from a nationwide, population-based cohort of 921 adults who underwent oesophagectomy for cancer between 2013 and 2019. Among 569 eligible patients, 383 (67%) participated in the study. Patient and clinical characteristics were retrieved from national health registries and medical records. Postoperative reflux was self-reported 1 year after surgery in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire module for gastroesophageal symptoms. Multivariable regression models provided odds ratios (OR) with 95% confidence intervals (CI). The performance of the model was evaluated using the area under the receiver-operating characteristic curve. ResultsFemale sex (OR 2.24, 95% CI: 1.00–5.00), preoperative reflux (OR 2.99, 95% CI: 1.61–5.52), and preoperative body mass index ≥30 (OR 2.45, 95% CI: 1.32–4.54) increased the risk of postoperative reflux. A model based on age, sex, preoperative reflux, body mass index, chronic obstructive pulmonary disease, and ventricle substitute predicted 72% of the severe cases. ConclusionFemale sex, preoperative reflux, and preoperative body mass index increased the risk of postoperative reflux. A combination of readily available patient and preoperative clinical variables showed fairly good accuracy in predicting postoperative reflux after oesophagectomy. The clinical risk prediction model may be helpful for early symptom management but needs to be externally validated before wider use.

The role of religious coping and social support on medication adherence and quality of life among the elderly with type 2 diabetes.

Type 2 diabetes is a major public health issue particularly in the elderly. Religion may affect the Health Related Quality of Life (HRQoL) in such patients, mediated by factors such as religious coping and social support. This study aimed to investigate the impact of religiosity on medication adherence and HRQoL. 793 adults (> 65years old, 45% females) were recruited from 4 diabetes care centers and followed for 1 year. Duke University Religion Index, Spiritual Coping Strategies, Multidimensional Perceived Social Support, Medication Adherence Report Scale, WHOQOL-BREF and Diabetes-specific Quality of Life Questionnaire Module were used for assessment, as well as HbA1c and fasting blood glucose level. Using structural equation modeling, the potential paths were tested between religiosity, medication adherence and HRQoL; social support, religious coping and medication adherence served as the mediators. Religious coping and social support were recognized as the significant mediators between religiosity and medication adherence (CFI = 0.983, TLI = 0.985, and RMSEA = 0.021). The relationships between religiosity and HRQoL were considerably mediated by social support, religious coping and medication adherence and these variables explained 12% and 33% of variances of generic and specific HRQoL, respectively. There was no significant direct effect of religiosity on HRQoL. HbA1c and fasting blood glucose level were successfully loaded on the latent construct of medication adherence (factor loading = 0.51 and 0.44, respectively). The impact of religiosity on medication adherence and HRQoL occurs through the mediators such as religious coping and social support. Therefore, to improve the adherence to treatment and quality of life, interventions may be designed based on these mediators.

Efficacy of oral administration of cystine and theanine in patients with colorectal cancer undergoing capecitabine-based adjuvant chemotherapy after surgery: study protocol for a multi-institutional, randomised, double-blinded, placebo-controlled, phase II trial

IntroductionAlthough adjuvant capecitabine therapy for patients with colorectal cancer after surgery often causes adverse events (AEs), such as diarrhoea, stomatitis, anorexia and hand-foot syndrome (HFS), there are no standard prevention...

Development of diabetes-specific quality of life module to be in conjunction with the World Health Organization quality of life scale brief version (WHOQOL-BREF)

BackgroundAlthough numerous health-related quality of life (HRQoL) instruments are available for patients with diabetes, the length of these measures may limit their feasibility to routine practice. Also, these measures do not distinguish items for generic and diabetes-specific HRQoL. This study was aimed to develop a diabetes-specific quality of life questionnaire module (DMQoL) to be in conjunction with the World Health Organization Quality of Life scale brief version (WHOQOL-BREF).MethodsOne hundred seventeen patients with diabetes were enrolled from a medical center in Taiwan. The item content of DMQoL was constructed based on an extensive review of existing HRQoL instruments for diabetes, expert discussions and patient interviews. A series of psychometric tests were conducted to ensure the reliability and validity of DMQoL. The WHOQOL-BREF served as an existing HRQoL measure for construct validity testing. The response scale of DMQoL was adopted from the 5-point Likert scale of WHOQOL-BREF.ResultsA total of 10 items without ceiling or floor effects were selected from 20 items. Exploratory factor analysis (EFA) with parallel analysis and Rasch analysis concluded that the 10 items were embedded in the same underlying concept. The corrected item-total correlations and factor loadings from EFA were all above 0.4. The internal consistency of the 10 items was satisfactory (Cronbach’s α = 0.84). The DMQoL total score was moderately correlated with that of WHOQOL-BREF (r = 0.48, p < 0.001). The known-group validity showed that patients with HbA1c ≤ 7% had significantly higher mean scores of DMQoL than did those with HbA1c > 8% (3.66 ± 0.47 vs. 3.41 ± 0.53; p = 0.037).ConclusionsThe DMQoL with only 10 items is developed and it is sensitive to the change of diabetes progression in early phases (e.g., glycemic changes). The combination of WHOQOL-BREF and DMQoL provides a comprehensive picture of overall HRQoL in patients with diabetes and enhance the instrument’s ability to detect clinically meaningful changes in diabetes.

Psychometric analysis of the Korean version of the high-dose chemotherapy specific quality of life questionnaire module from the European Organization for Research and Treatment of Cancer (EORTC QLQ-HDC29).

We evaluated the psychometric properties of the Korean version of the European Organization for Research and Treatment of Cancer high-dose chemotherapy specific quality of life questionnaire module (EORTC QLQ-HDC29) when implemented with Korean patients by conducting a multicenter, longitudinal study in three Korean hospitals. A total of 226 patients who scheduled to receive the HDC followed by hematopoietic stem cell transplantation (HSCT) were enrolled. The patients were asked to complete three questionnaires [the EORTC Core Questionnaire (QLQ-C30), QLQ-HDC29, and the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation] at four points in time: before HSCT and 100, 180, and 365 days after HSCT. Standard validity and reliability analyses were performed. Internal consistency of the QLQ-HDC29 was generally acceptable, as tested by Cronbach's α, except for the scales body image and the inpatient issues. Cronbach's α values for the Korean version of the QLQ-HDC29 were almost in accordance with results of the original version, except for the scales body image (lower to the original QLQ-HDC29, α = 0.73) and impact on family (higher to the original QLQ-HDC29, α = 0.52). Known-group comparison analyses showed significantly higher symptom burdens in patients with poor performance status or graft versus host disease (similar to the original QLQ-HDC29). The QLQ-HDC29 indicated good convergent and discriminant validity and showed responsiveness to changes in line with a clinical course over time after HSCT. The QLQ-HDC29 is generally reliable and adequate to assess QoL in Korean patients undergoing HDC followed by HSCT.

O1-4-6 - A Systematic Review of Measurement Properties of Quality of Life Instruments Used in Patients with Colorectal Cancer

Background: To critically appraise the measurement properties of standardized health-related quality of life (HRQOL) instruments for colorectal cancer (CRC) patients, and to provide recommendations on the use of HRQOL instrument through collective evidence from previous studies.Materials: Systematic review of English-language literature published between January 1985 and December 2011 was conducted through the database search of Pubmed, Web of Science, Embase, and OVID Medline. Methodological quality of each eligible study and overall levels of evidence per measurement property and per HRQOL instrument were rated using a COSMIN checklist.Results: Thirty-nine studies reporting 27 standardized HRQOL instruments for CRC patients were identified. Methodological quality of hypothesis testing and internal consistency was evaluated most frequently. The Functional Assessment of Cancer Therapy-Colorectal (FACT-C) in Functional Assessment of Chronic Illness Therapy (FACIT) was the most extensively evaluated in eight out of nine measurement properties. The highest number of positive sign in the overall level of evidence was obtained in the colorectal cancer-specific quality of life questionnaire module (QLQ-CR38) in European Organisation for Research and Treatment of Cancer (EORTC) module, the FACT-C in FACIT module, Quick-FLIC and MSKCC Bowel Function instruments.Conclusion: For clinical use, the FACT-C was suggested to assess HRQOL in patients with CRC regardless of disease stage whereas the measurement property of MSKCC Bowel Function instrument was satisfactory in measuring HRQOL in rectal cancer patients. To facilitate the proper access to the overall level of evidence of HRQOL instruments, this review emphasized the need for high-quality and standard reporting of measurement properties of the existing and newly-developed HRQOL instruments for CRC patients.

Phase III development of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for women undergoing breast reconstruction

Comprehensive outcome assessments after breast reconstruction (BRR) require surgery-specific patient-reported outcome measures. The aims of this study were to assess the relevance, acceptability and redundancy of questions/items (phase III pretesting) of a new BRR questionnaire evaluating patients' health-related quality of life before and after BRR. Phase III occurred in collaboration with the European Organization for Research and Treatment of Cancer (EORTC) following earlier development phases that identified 31 items. The EORTC BRR subgroup applied decision-making rules to each question according to eight EORTC criteria. A total of 197 patients (from the UK, Austria, Belgium, Italy and Sweden) were recruited. Forty-seven patients completed pre- and post-BRR questionnaires prospectively, and 150 reported post-BRR questionnaires only retrospectively. Qualitative debriefing interviews were undertaken in 189 patients. Preliminary psychometric analyses were performed. Thirty-one items fulfilled 'relevance', with none producing 'difficulties'. Ten items were not a priority for 10 per cent of respondents. Of these, two questions concerning muscle twitching in the affected breast and problem with donor-site swelling were deleted. Three redundant items were deleted: weakness in arm, which correlated significantly to the Quality of Life Questionnaire (QLQ) BR23 breast questionnaire, and shape and colour of the affected nipple. Descriptive statistics reduced the module to 26 items conceptualized into three provisional scales (disease treatment/surgery-related symptoms, sexuality and cosmetic outcome) within the newly completed questionnaire, EORTC QLQ-BRR26. The QLQ-BRR26 is available for psychometric validation in a large-field international sample. The intended use for QLQ-BRR26 is alongside EORTC QLQ-C30 and QLQ-BR23, in women treated by mastectomy for breast cancer and undergoing all types of BRR.

Quality of Life After Surgery for Colon Cancer in Patients With Lynch Syndrome

Lynch syndrome is a disorder caused by mismatch repair gene mutations. Mutation carriers have a high risk of developing colorectal cancer. In patients with Lynch syndrome in whom colon cancer has been diagnosed, in general, subtotal colectomy instead of partial colectomy is recommended because of the substantial risk of metachronous colorectal cancer. However, the effect of more extensive surgery on quality of life and functional outcome is unknown. The aim of this study was to investigate quality of life and functional outcome in patients with Lynch syndrome after partial colectomy and subtotal colectomy. This is a nationwide cross-sectional study in the Netherlands. Two quality-of-life questionnaires (Short Form-36 and The European Organization for Research and Treatment of Cancer Colorectal Cancer-specific Quality of Life Questionnaire Module) and a functional outcome questionnaire (Colorectal Functional Outcome) were used. Patients with Lynch syndrome who underwent surgery for colon cancer were included. The primary outcomes measured were quality of life and functional outcome. Questionnaires were sent to 192 patients with Lynch syndrome who underwent surgery for colorectal cancer. A total of 136 patients returned the questionnaire (response rate, 71%). Eighteen patients with rectal cancer, 9 patients with a permanent ileostomy, and 5 patients with an IPAA were excluded. Fifty-one patients underwent partial colectomy, and 53 underwent subtotal colectomy. None of the scales of the Short Form-36 survey showed a significant difference. Analysis of the Colorectal Functional Outcome questionnaire revealed that, after subtotal colectomy, patients have a significantly higher stool frequency (p ≤ 0.01) and a significantly higher score on stool-related aspects (p = 0.06) and social impact (p = 0.03). The European Organization for Research and Treatment of Cancer Colorectal Cancer-specific Quality of Life Questionnaire Module presented more problems with defecation after subtotal colectomy (p ≤ 0.01). Certain selection bias cannot be ruled out. Although functional outcome is worse after subtotal colectomy than after partial colectomy, generic quality of life does not differ after the 2 types of surgery in Lynch syndrome. When discussing the options for surgery with the patient, all advantages and disadvantages of both surgical procedures, including quality of life and functional outcome, should be discussed.

Validation of the Japanese version of the EORTC hepatocellular carcinoma-specific quality of life questionnaire module (QLQ-HCC18).

BackgroundThis study examined the measurement properties of the Japanese version of the European Organisation for Research and Treatment of Cancer (EORTC) Hepatocellular Carcinoma-Specific Quality of Life Questionnaire (QLQ-HCC18).MethodsEORTC quality of life (QOL) translation guidelines were followed to create a Japanese version of the EORTC QLQ-HCC18. This was then administered to 192 patients with hepatocellular carcinoma along with the EORTC QLQ-C30 and FACT-Hep questionnaires. Tests for reliability and validity were conducted including comparison of scores between the EORTC and FACT questionnaire and detailed assessment of the new scales and items in clinically distinct groups of patients.ResultsMulti-trait scaling analysis confirmed three putative scales in the QLQ-HCC18, fatigue, fever and nutrition. Cronbach’s alpha for these scales were between 0.68 and 0.78. The QLQ-HCC18 scales correlated with scales measuring similar items in the FACT-Hep and the questionnaire was stable over time with an intra-class correlation score of 0.70 for almost all scales. The questionnaire had the ability to distinguish between patients with different Karnofsky Performance Status, and Child-Pugh liver function class.ConclusionsThe Japanese version of EORTC QLQ-HCC18 is a reliable supplementary measure to use with EORTC QLQ-C30 to measure QOL in Japanese patients with hepatocellular carcinoma.

Exploring the quality of life and the impact of the disease among patients with colorectal cancer: A systematic review.

Background: Colorectal cancer has emerged as the most common cancer in Singapore. The quality of life has become increasing important in measuring the outcomes of colorectal cancer patients and the impact of the disease on a person's life. The objective of this review was to synthesize the best available evidence on the factors that have an impact on the Quality of Life of patients with colorectal cancer. All primary quantitative studies published in English were considered for inclusion in the review. An extensive electronic database search was conducted since database inception to the December 2010 to identify potential relevant studies using CINAHL, PUBMED/MEDLINE, PsycINFO (OVID, Scopus, ScienceDirect, Springerlink, Web of Science (Social Science Citation Index), Expanded Academic ASAP, Mosby's Nursing Consult, Sociological Abstracts, Mednar and Proquest. Two independent reviewers assessed the eligibility and methodological quality of the papers selected prior to inclusion using the appropriate standardised critical appraisal checklists from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument. The two reviewers resolved disagreement by discussion. Quantitative data were extracted from relevant studies using the appropriate standardised data extraction tool. Twenty papers were selected and assessed for relevancy. After further review, fifteen papers that met the level of methodological standard were included in this review. The extracted data included specific details about the interventions, participants' demographics, study methods and any outcomes of significance to the aim of the review. A meta-analysis was not appropriate due to the heterogeneity of methodology in the included studies, thus the findings were presented in a narrative form. The review included fifteen studies which consisted of twelve descriptive studies and the other three were case-control studies. The findings indicated that patients with colorectal cancer continue to suffer from depression, distress and bowel related problems such as constipation and diarrhoea which impacted their quality of life. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, Core Module (QLQ-C30), European Organisation for Research and Treatment of Cancer (EORTC) Colorectal Cancer-Specific Quality of Life Questionnaire Module (QLQ-CR38) and Short Form 36 were the commonly used instruments to assess QoL in this review and most of the instruments included psychological, physical, social and functional aspects. Younger colorectal cancer patients had poorer quality of life when compared to elderly patients. Colorectal cancer also had a greater impact on quality of life outcomes in women when compared to men. The evidence generated from this systematic review will assist in the provision of information to develop effective intervention strategies to enhance quality of life and well-being for patients with colorectal cancer and to alleviate and/or prevent a worsening of the symptoms. A pre and post surgery psychosocial assessment should be part of the routine health examinations for early detection of psychosocial problems in patients with colorectal cancer. Future research is needed to explore further the factors that impact the quality of life of patients with colorectal cancer with focus on problems like depression, and bowel symptoms. Psychosocial factors have a great impact on patients' perceived quality of life. There is a need to develop interventions such as psychoeducation and self-management programme to help those newly diagnosed cancer patients and long-term cancer survivors.

Development of the European Organisation for Research and Treatment of Cancer quality of life questionnaire module for older people with cancer: The EORTC QLQ-ELD15

Background and aim There is a lack of instruments that focus on the specific health-related quality of life (HRQOL) issues that affect older people with cancer. The aim of this study was to develop a HRQOL questionnaire module to supplement the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire, the EORTC QLQ-C30 for older (>70 years) patients with cancer. Methods Phases 1–3 were conducted in seven countries following modified EORTC Quality of Life Group guidelines for module development. Phase 1: potentially relevant issues were identified by a systematic literature review, a questionnaire survey of 17 multi-disciplinary health professionals and two rounds of qualitative interviews. The first round included 9 patients aged >70. The second round was a comparative series of interviews with 49 patients >70 years with a range of cancer diagnoses and 40 patients aged 50–69 years matched for gender and disease site. In Phase 2 the issues were formulated into a long provisional item list. This was administered in Phase 3 together with the QLQ-C30 to two further groups of cancer patients aged >70 ( n = 97) or 50–69 years ( n = 85) to determine the importance, relevance and acceptability of each item. Redundant and duplicate items were removed; issues specific to the older group were selected for the final questionnaire. Results In Phase 1, 75 issues were identified. These were reduced in Phase 2 to create a 45 item provisional list. Phase 3 testing of the provisional list led to the selection of 15 items with good range of response, high scores of importance and relevance in the older patients. This resulted in the EORTC QLQ-ELD15, containing five conceptually coherent scales (functional independence, relationships with family and friends, worries about the future, autonomy and burden of illness). Conclusion The EORTC QLQ-ELD15 in combination with the EORTC QLQ-C30 is ready for large-scale validation studies, and will assess HRQOL issues of most relevance and concern for older people with cancer across a wide range of cancer sites and treatment stages.

Personality traits and psychosocial stress: quality of life over 2 years following breast cancer diagnosis and psychological impact factors

The aim of this study was to investigate changes in the quality of life (QoL) and body image among breast cancer patients over 2 years and to examine different predictive factors for QoL 2 years after the primary operation. A total of 203 women with a primary diagnosis of breast cancer completed the questionnaires 2 weeks and 6, 12, 18, and 24 months after surgery. Quality of Life Questionnaire (QLQ-C30), Breast Cancer Specific Quality of Life Questionnaire Module (QLQ-BR23), Questionnaire on Stress in Cancer Patients (QSC-R23), Freiburg Personality Inventory (FPI-R), Life Orientation Test (LOT) were used as standardized measures. The overall QoL and most functional and symptom scales improved during the 2-year period. However, cognitive functioning, body image, and the three symptom scales of insomnia, constipation, and diarrhea did not change. Age was only capable of predicting physical functioning, whereas tumor size, axillary surgery, and adjuvant chemotherapy were not predictive of the long-term QoL functional scores. Initial distress was the most potent predictive factor for long-term QoL. Baseline functioning predicted functional QoL scores 2 years later. And higher scores for neuroticism were associated with a poorer QoL. However, optimism was not capable of predicting the QoL 2 years later. Screening measures should be implemented at the time when breast cancer is diagnosed, in order to identify psychologically vulnerable patients and offer them professional psycho-oncological help.

Gemcitabine versus cisplatin, epirubicin, fluorouracil, and gemcitabine in advanced pancreatic cancer: a randomised controlled multicentre phase III trial

Patients with advanced pancreatic adenocarcinoma have a poor response, progression-free survival, and overall survival with standard treatment. We aimed to assess whether a four-drug regimen could improve 4 month progression-free survival compared with gemcitabine alone. In a randomised multicentre phase III trial, 52 patients were randomly assigned to 40 mg/m2 cisplatin and 40 mg/m2 epirubicin both given on day 1, 600 mg/m2 gemcitabine given intravenously over 1 h on days 1 and 8, and 200 mg/m2 fluorouracil a day given by continuous infusion on days 1-28 of a 4-week cycle (PEFG regimen), and 47 were assigned to 1000 mg/m2 gemcitabine given intravenously over 30 min once a week for 7 of 8 consecutive weeks in cycle 1 and for 3 of 4 weeks thereafter. The primary endpoint was 4-month progression-free survival. Secondary endpoints were overall survival, objective response, safety, and quality of life. Analyses were by intention to treat. 51 patients assigned PEFG and 46 assigned gemcitabine alone had disease progression. 49 patients in the PEFG group and 46 in the gemcitabine group died from progressive disease. More patients allocated PEFG than gemcitabine alone were alive without progressive disease at 4 months (60% [95% CI 46-72] vs 28% [17-42]; hazard ratio [HR] 0.46 [0.26-0.79]). 1-year overall survival in the PEFG group was 38.5% (25.3-51.7) and in the gemcitabine group was 21.3% (9.6-33.0; HR 0.68 [0.42-1.09]). More patients assigned PEFG showed disease response than did those assigned gemcitabine (38.5% [25.3-51.7] vs 8.5% [0.5-16.5]; odds ratio 6.60 [2.11-20.60], p=0.0008). More patients in the PEFG group had grade 3-4 neutropenia and thrombocytopenia than in the gemcitabine group (p<0.0001). The PEFG regimen could be considered for treatment of advanced pancreatic adenocarcinoma.

A pilot study of the translation, cultural adaptation and validation of the EORTC head and neck cancer quality of life questionnaire module (QLQ-H&N35) for use in Japan

Development of the Japanese version of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-head and neck 35 (H&N35) module for use in Japan. Phase 1: The First Intermediary Japanese version was produced according to the EORTC Quality of Life (QOL) Unit translation project guideline. The Second Intermediary version was a result of the backward translation project and two peer-to-peer discussion settings by health care professionals related to the project. Phase 2: Focus group discussions with team members and semi-structured interviews with 108 participants to produce the final Japanese version. Our cultural-adaptation and validation yielded scores that are reliable by internal consistency (Cronbach's alpha) and the validation results showed acceptable correlation results by Pearson's Product Moment Correlation Coefficient ( r). The questionnaire was well accepted and the response rate was high (93.9%). Convergent validity was moderate to high (from r = 0.55 to 0.97, P < 0.01) and discriminant validity was low; Cronbach's α coefficients of most scales had good reliability ( α ≥ 0.70), except that of pain scale. In Japan, however, some correlation patterns between scales differed from that in the original European countries and cultures. The use of both qualitative and quantitative methods was important in developing the Japanese version of the QLQ-H&N35 module. We conclude that the Japanese version has good psychometric validity, thus it is recommended for further study to assess health-related quality of life (HRQOL) in Japanese head and neck cancer patients.

The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38)

The objectives of the current study were to construct a colorectal cancer-specific quality of life (QL) questionnaire module to be used in conjunction with the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and to test its reliability and validity in The Netherlands. Module construction took place following the EORTC guidelines for module development. The module—the QLQ-CR38—consists of 38 items covering symptoms and side-effects related to different treatment modalities, body image, sexuality and future perspective. This module was tested among 117 colorectal cancer patients on several occasions. The timing was prior to treatment with radiotherapy or chemotherapy, during treatment and 3 months following the second assessment. For purposes of test–retest reliability, a subsample of patients completed the QLQ-CR38 1 week following the third assessment. Multitrait scaling analysis confirmed the hypothesised scale structure of the function scales but not of the symptom scales. Cronbach’s alpha coefficients for seven of the nine scales exceeded the 0.70 criterion at one or both assessments. The test–retest reliability for all scales and one single item was 0.78 or higher. The stability of the two remaining single items was lower. On the basis of known-groups comparisons, selective scales distinguished clearly between patients differing in disease stage, initial and on-treatment performance status and the presence of a stoma. Additionally, selective scales detected change over time as a function of change in performance status and treatment-induced change. These results lend support to the clinical validity of the QLQ-CR38 as a supplementary questionnaire for assessing specific QL issues relevant to patients with colorectal cancer. Additional efforts to test the module’s cross-cultural validity are needed.