The impact of electronic versus paper-based data capture on data collection logistics and on missing scores in thyroid cancer patients.

PURPOSE: The purpose of this study was to investigate the impact of the type of data capture on the time and help needed for collecting patient-reported outcomes as well as on the proportion of missing scores. METHODS: In a multinational prospective study, thyroid cancer patients from 17 countries completed a validated questionnaire measuring quality of life. Electronic data capture was compared to the paper-based approach using multivariate logistic regression. RESULTS: A total of 437 patients were included, of whom 13% used electronic data capture. The relation between data capture and time needed was modified by the emotional functioning of the patients. Those with clinical impairments in that respect needed more time to complete the questionnaire when they used electronic data capture compared to paper and pencil (ORadj 24.0; p = 0.006). This was not the case when patients had sub-threshold emotional problems (ORadj 1.9; p = 0.48). The odds of having the researcher reading the questions out (instead of the patient doing this themselves) (ORadj 0.1; p = 0.01) and of needing any help (ORadj 0.1; p = 0.01) were lower when electronic data capture was used. The proportion of missing scores was equivalent in both groups (ORadj 0.4, p = 0.42). CONCLUSIONS: The advantages of electronic data capture, such as real-time assessment and fewer data entry errors, may come at the price of more time required for data collection when the patients have mental health problems. As this is not uncommon in thyroid cancer, researchers need to choose the type of data capture wisely for their particular research question.

International Phase IV Field Study for the Reliability and Validity of the European Organisation for Research and Treatment of Cancer Thyroid Cancer Module EORTC QLQ-THY34.

Purpose: The aim of this study was to validate the new European Organisation for Research and Treatment of Cancer Quality of Life Thyroid Cancer Module (EORTC QLQ-THY34). Methods: We enrolled 437 thyroid cancer patients from 17 countries. One group (n = 303), undergoing treatment or best supportive care, completed the questionnaires at three time points (before therapy [t1], 6 weeks later [t2], and 6 months after t2 [t3]). A second group (survivors ≥2 years after diagnosis, n = 134) completed it at a random baseline time point and a second time 1 week later. We determined internal consistency (using Cronbach's alpha), the scale structure (with confirmatory factor analysis), and discriminant validity (using known-group comparisons). Group 1 data were used to assess responsiveness and group 2 data to determine test-retest reliability using intra-class correlations (ICC). Results: All 34 items fulfilled the criteria to be kept in the questionnaire. Cronbach's alpha was >0.70 in 8 of the 9 multi-item scales. All standardized factor loadings exceeded 0.40, confirming the proposed scale structure. The ICC was >0.70 in all scales expressing good test-retest reliability. Differences in scale scores between patients with different histology were >5 points in all scales. In all but one of the pre-specified scales (Dry Mouth), changes over time were ≥|4| points between at least two time points. Conclusion: The EORTC QLQ-THY34 with its 9 multi-item and 8 single-item scales is a reliable and valid tool to measure quality of life in thyroid cancer patients and can be used in future trials and studies.

Head and neck paragangliomas in Norway, importance of genetics, updated diagnostic workup and treatment.

BACKGROUND: Head and neck paragangliomas (HNPG) are rare and predominantly benign tumours, originating from the neuroendocrine paraganglionic system. A considerable proportion of HNPGs are hereditary, depending on the population. AIMS/OBJECTIVES: The purpose of this study was to estimate the rate of hereditary HNPGs in a Scandinavian (Norwegian) population, report long-term experience with HNPGs and offer all patients diagnosed an updated follow-up, with emphasis on identifying hereditary HNPGs through genetic screening and multifocality by 18 F-2-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT). MATERIAL AND METHODS: Our study was a partly retrospective and partly prospective cohort study. It included patients with HNPG diagnosed at Oslo University Hospital (OUH), Rikshospitalet between 1990 and 2017. The patients underwent genetic testing, 18F-FDG PET/CT and measurement of catecholamines and meta-nephrines in the plasma. All resection specimens and biopsies were subjected to histopathological review. The genetic testing protocol consisted of testing for mutations in the following genes; SDHD, SDHB, SDHC, VHL and RET. RESULTS: Sixty-three patients were included in the study with a median age of 49 years (range 12 - 80). Cranial nerve dysfunction was present upon diagnosis in 13%, and 14% had multifocal paraganglioma (PG) disease. Fifty-six patients (89% of all the patients) underwent genetic testing, and 29% of these had a PG related mutation. Seven of the eight patients (88%) with multifocal PGs who underwent genetic testing had a mutation. In two of the patients, the 18F-FDG PET/CT revealed unknown and subclinical multifocality. CONCLUSIONS AND SIGNIFICANCE: This is the first study with systematic genetic workup and PET/CT imaging in Scandinavia of HNPG patients. The mutation rate was within the lower range reported in the literature with respect to HNPGs. Combining genetic testing and PET/CT imaging in the diagnostic workup of HNPGs is valuable.

EORTC Quality of Life Questionnaire Head and Neck (H&N)-35 scores from H&N squamous cell carcinoma patients obtained at diagnosis and at 6, 9 and 12 months following diagnosis predict 10-year overall survival.

PURPOSE: To study the 10-year overall survival predictions, and mechanisms behind, of head and neck (HN) quality of life (QoL) scores obtained at diagnosis and 6, 9, and 12 months following diagnosis in a cohort of HN squamous cell carcinoma (HNSCC) patients. METHODS: Consecutive HNSCC patients (N = 109) subjected to standard workup and treatment self-reported their QoL measured by the EORTC Quality of Life Questionnaire (QLQ) H&N-35 between November 2002 and June 2005. Each QoL index was calculated and additionally aggregated to one sum score. The included patients were at diagnosis younger than 78 years, judged adequately cognitive functioning, and scheduled for curative treatment. Self-reported smoking, alcohol consumption, and socio-demographic information were registered. Twenty-two patients were high-risk (hr)-HPV DNA tumor positive. If the treatment goal was changed to palliative, no new QoL information was collected. All living patients were followed until 10 years after diagnosis. RESULTS: Median survival was 105 months. Significant overall survival predictions were found from the EORTC H&N-35 QLQ sum scores continuously measured at diagnosis (p = 0.006) and obtained at 6 (p = 0.02), 9 (p = 0.002) and 12 (p = 0.05) months. Lower QoL predicted lower overall survival. These sum score survival predictions were in part independent of TNM stage, hr-HPV status, gender, age, alcohol and smoking status. The indices "pain", "swallowing", "social eating", and "feeling ill" were predictive of survival at 3 out of 4 measuring points (diagnosis, 6, 9 and 12 months) in univariate analyses. CONCLUSION: EORTC H&N-35 QLQ scores at diagnosis and throughout the first year thereafter harbor prognostic power.

General health-related quality of life scores from head and neck squamous cell carcinoma patients obtained throughout the first year following diagnosis predicted up to 10-year overall survival.

OBJECTIVES: To evaluate the 5- and 10-year survival prediction of health-related quality of life (HRQoL) scores obtained at diagnosis and at 6, 9 and 12 months after diagnosis in a cohort of curable head and neck squamous cell carcinoma (HNSCC) patients. MATERIALS AND METHODS: HNSCC patients (n = 109) reported their HRQoL measured by the EORTC Quality of Life Questionnaire (QLQ) general (C30) questionnaire. At diagnosis, the included patients were below 78 years of age and at diagnosis planned treated with curative intent. Clinical variables and self-reported smoking, alcohol consumption and socio-demographic information were registered. From diagnostic blocks, we found 22 patients to be human papillomavirus (HPV) positive. New HRQoL scores were not obtained if the patient treatment changed from curative to palliative throughout the HRQoL data acquisition. Survival was determined from the National Population Register of Norway. RESULTS: Decreased survival with low HRQoL scores from EORTC QLQ scores was demonstrated with HRQoL scores obtained from different time points of the four time points studied. These survival predictions were mostly independent of HPV status, gender, age, TNM stage, tumor site, alcohol consumption, present smoking status and whether comorbidities were present at diagnosis; as well as to some extent with an adjustment of the same HRQoL score/index obtained at diagnosis. The specific indices "physical function", "general pain" and "sleep disturbance" were in particular predictive of survival. CONCLUSION: HRQoL scores obtained throughout the first year after diagnosis contained prognostic power to overall survival when measured both at 5 and 10 years of observation.

Level of distress predicts subsequent survival in successfully treated head and neck cancer patients: a prospective cohort study.

CONCLUSION: Our findings indicate a unique survival prediction from general health questionnaire (GHQ) sum scores in successfully treated head and neck squamous cell carcinoma (HNSCC) patients and also to some extent with inclusion of health-related quality of life (HRQoL) scores. OBJECTIVE: To examine the survival prediction from the level of distress, measured by GHQ scores obtained from at inclusion successfully treated HNSCC patients. METHODS: Structured interviews were conducted for 135 successfully treated cognitive functioning HNSCC patients 67 ± 31 (mean ± SD) months after diagnosis following a regular follow-up visit. GHQ scores, alcohol consumption history, smoking status, present comorbidities, level of neuroticism, choice of psychological coping with the cancer disease, and HRQoL scores (EORTC QLQ-C30 and -H&N35) were determined. The TNM stage, treatment provided and tumour site were obtained from the hospital records. Forty-three deaths were noted during a minimum 8.5 years of observation. RESULTS: The GHQ sum scores predicted survival in univariate (p < 0.05) and multivariate analyses with the above-mentioned covariates included (p < 0.01). Using clinically relevant cut-off levels, GHQ scores predicted survival in both univariate (hazard ratio (HR) 1.9; p = 0.05) and multivariate Cox regression analyses (HR 3.8; p = 0.001). We also demonstrated survival prediction from GHQ scores when adjusted by HRQoL scores.

Prediction of 5 year survival from level of perceived distress in newly diagnosed head and neck squamous cell carcinoma patients.

OBJECTIVES: To evaluate the predictive effect of level of perceived distress on survival in a cohort of newly diagnosed head and neck squamous cell carcinoma (HNSCC) patients. MATERIALS AND METHODS: One hundred and one (N=101) consecutive HNSCC patients self-reported their levels of distress, measured with the general health questionnaire 30 (GHQ-30) at the time of diagnosis. All included patients were younger than 78years of age, cognitive adequate functioning, and scheduled for curative treatment. At the time of diagnosis self-reported levels of neuroticism, problem and avoidance focused coping, smoking and alcohol consumption, and sociodemographic information were registered. Clinical characteristics and comorbidities were determined from the patient hospital records. RESULTS: The 5-year overall survival of the cohort was 68.3%. Thirty-two deaths occurred during the 5-year observation period. The Likert analyzed GHQ sum score, as well as a dichotomized GHQ score were found to predict survival in univariate Cox proportional hazards regression analyses. The hazard ratios were 1.04 (p=.04) and 2.78 (p=.01), respectively. The predictive effect of the GHQ scores remained significant throughout sequential multivariate analyses with adjustments for all the above mentioned covariates. Even a post hoc analysis including all covariates demonstrated an evident survival prediction. CONCLUSION: Self-reported distress measured pretreatment in newly diagnosed HNSCC patients predict survival. Further studies are warranted to elucidate mechanisms and possible interventions.

Prediction of survival by pretreatment health-related quality-of-life scores in a prospective cohort of patients with head and neck squamous cell carcinoma.

OBJECTIVE: To evaluate the association between pretreatment health-related quality-of-life (HRQOL) scores and survival in a heterogeneous cohort of patients with newly diagnosed head and neck squamous cell carcinoma (HNSCC). DESIGN: Prospective cohort study. SETTING: University hospital and referral center in Western Norway. PATIENTS: A total of 106 patients with intact cognitive functioning who were younger than 78 years, were diagnosed as having HNSCC, and underwent treatment with curative intent from November 1, 2002, through June 30, 2005. MAIN OUTCOME MEASURES: Overall survival and HRQOL scores obtained at the time of diagnosis. RESULTS: All dichotomized HRQOL sum scores except the functional score (P = .20) were significantly predictive of survival in univariate analyses. The hazard ratios of the dichotomized general symptom, global quality-of-life, and head and neck sum score were 3.66, 0.31, and 2.28, respectively. All sum scores except the dichotomized functional score remained predictive of survival after sequential adjustment for sociodemographic and clinical characteristics, neuroticism, choice of psychological coping, current smoking and alcohol consumption, and comorbidities. Similar findings were found for specific HRQOL indices of physical functioning, dyspnea, sleep disturbance, appetite loss, swallowing, and social eating from the European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire, version 3.0, and the Quality of Life-Head and Neck Cancer Module. Moreover, patients in the highest scoring quartiles for the symptom sum scores and/or the lowest scoring quartile for the global score had overall mortality rates of 50% to 64% compared with 23% to 26% among the other patients. CONCLUSION: The HRQOL sum scores and specific indices among HNSCC patients predict survival independently of established known prognostic factors.

Comorbidity is an independent predictor of health-related quality of life in a longitudinal cohort of head and neck cancer patients.

The aims of this study were to evaluate the validity and reliability of self-reported measurements of comorbidity, as well as the impact of comorbidity on health-related quality of life (HRQoL) scores, obtained at the time of diagnosis and at 18 months follow-up, among head and neck squamous cell carcinoma (HNSCC) patients treated with curative intent. One hundred and six (106) patients were available for analyses at the time of diagnosis and 72 patients at 18 months follow-up. HRQoL was assessed with the EORTC QLQ-C30/H&N35 inventories. The presence of comorbidities was assessed with a self-reported eight-question-based questionnaire at the time of diagnosis and after 18 months, as well as retrospectively with the Adult Comorbidity Evaluation (ACE-27) scale. The self-reported eight-question-based assessments of comorbidity showed high reliability with the chart-based ACE-27 inventory at both time points (r = 0.611, p < 0.001 and r = 0.612, p < 0.001). Significant correlations with comorbidity were determined for the functional (r = -0.194, r = -0.269) and the general symptom HRQoL sum score (r = 0.257 and r = 0.334) at the time of diagnosis and after 18 months; in particular present lung disease explained these associations. The covariates marital status, smoking status, alcohol consumption, and tumor stage were also found to be significantly associated with HRQoL sum scores at both time points. In conclusion, we have demonstrated that it is possible to assess comorbidity in HNSCC patients by self-reported questionnaires. Moreover, comorbidities, in particular present lung disease, appear to have an important and unique influence on HRQoL scores.

Stability of distress and health-related quality of life as well as relation to neuroticism, coping and TNM stage in head and neck cancer patients during follow-up.

CONCLUSION: Distress and to some extent health-related quality of life (HRQoL) in head and neck squamous cell carcinoma (HNSCC) patients was found to be stable during follow-up. About one-third of the distress and HRQoL variances were accounted for in the present investigation with one-third from T stage, one-third directly from neuroticism and one-third from neuroticism via choice of coping response. In addition, choice of coping response predicted directly 5% of the HRQoL variance. OBJECTIVE: To investigate the stability of distress and HRQoL as related to neuroticism and choice of coping response in HNSCC patients during a follow-up period of 4 years. METHODS: We determined distress by the general health questionnaire (GHQ), HRQoL, personality by the Eysenck Personality Questionnaire (EPQ) and choice of coping response. All patients younger than 78 years with new HNSCC in Western Norway in the period 1992-2001 following successful treatment were interviewed. We determined GHQ and EORTC QLQ C30/H&N35 a second time after 4 years. RESULTS: The GHQ scores were stable, whereas the HRQoL sum scores declined slightly (p < 0.001). The GHQ and the HRQoL scores were predicted by neuroticism, avoidant coping pattern, T stage and smoking history, but primarily H&N-specific HRQoL was predicted by treatment-derived factors.

Head and neck specific Health Related Quality of Life scores predict subsequent survival in successfully treated head and neck cancer patients: a prospective cohort study.

To examine the survival prediction of head and neck (H&N) Health Related Quality of Life (HRQoL) scores among successfully treated and cognitive functioning H&N squamous cell carcinoma (HNSCC) patients. Through structured interviews, self-reported questionnaires were given to 139 successfully treated HNSCC patients, 67 ± 32 months following diagnosis. HRQoL-scores, measured with the EORTC QLQ-H&N35 inventory, self-reported levels of neuroticism, avoidance focused coping, coping by suppression of competing activity, alcohol consumption, smoking status, and heart and lung disease, as well as gender, age, TNM-stage, and tumor site were determined. The mean observation period was 75 ± 4 months among the survivors. Twenty-four deaths were observed. A EORTC QLQ-H&N 35 sum score, including a dichotomized version (HR 2.73-3.67), was predictive of survival, both directly and after adjustment for all of the above mentioned variables. The H&N HRQoL indices "feeling ill", "sexuality", "open mouth", "swallowing", and "pain" specifically predicted survival. The dichotomized H&N HRQoL sum score compared the 4th upper quartile to the three lower quartiles, and a cut off value of 28.5 was designated. Analyses demonstrated that a high risk group with 33% mortality may include only one quarter of the patient population as opposed to 12.5% mortality among the other patients. Our findings indicate a unique survival prediction from EORTC QLQ-H&N 35 sum scores in successfully treated HNSCC patients. HRQoL scores, in particular, related to oral health, predicted survival. Furthermore, HRQoL-scores may be a screening tool for identifying patients with high mortality risk.

Distress, quality of life, neuroticism and psychological coping are related in head and neck cancer patients during follow-up.

UNLABELLED: The aim of the present study was to study the relation between distress, quality of life (QoL), personality and choice of coping in successfully treated head and neck squamous cell carcinoma (HNSCC) patients, and to study whether distress could be regarded as a QoL variable. MATERIAL AND METHODS: We determined present distress by the general health questionnaire (GHQ), QoL by the European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC-QLQ) C30/H&N35, personality by the Eysenck Personality Inventory and coping by the COPE questionnaire. All patients younger than 80 years who had been diagnosed with HNSCC in Western Norway in the period from 1992 to October 2001, and who had survived at least 12 months without evidence of disease were interviewed. In addition, treatment level, TNM stage, alcohol consumption level as well as smoking level were determined. One hundred and thirty-nine patients (96.5% response rate) were included. RESULTS: Distress and QoL indexes were scored with a common variance (CV) between 20% and 35%. The measured variables account for 40-48% of the variance of the QoL/GHQ scores. Between 3% and 10% of the GHQ/general QoL scores and 10% of the variance of the H&N35 QoL scores were predicted by the TNM stage. The measured psychological factors accounted for 20% of the H&N35 QoL scores and 40% of the measured variance of the general QoL and GHQ responses. High neuroticism (CV≈20-35%), present avoidance coping (CV≈10-30%) and coping by suppression of competing activity (CV≈10-20%) were associated with low QoL and high distress. CONCLUSION: GHQ and QoL scores are scored similar, and are to some extent predicted by treatment related factors, but between 2.5 and 10 times more closely associated with psychological factors. Distress may possibly also be regarded as a QoL variable.