Quality Of Life Questionnaire For Patients Research Articles

Current Quality-of-Life Aspects in Patients with Classical Ph-Negative Myeloproliferative Neoplasms in the Russian Federation: Overview of the Outcomes of the National Observational Program MPN-QoL-2020

Background. The national observational program MPN-QoL-2020 was focused on quality of life (QoL) and symptoms in patients with classical Ph-negative myeloproliferative neoplasms (MPNs) in the Russian Federation, as well as on the perception of the disease and treatment from the patient's and physician's perspective. Aim. To evaluate QoL in patients with different MPNs using new standardized questionnaires, to assess the most common symptoms and their impact on QoL in patients with myelofibrosis (MF), polycythemia vera (PV) and essential throm-bocythemia (ET), and to characterize the perception of the disease and treatment concerns from patients' perspective and their treating physicians' perspective. Materials & Methods. In total 1100 patients with MPNs (MF: n = 355, PV: n = 408, and ET: n = 337; mean age 58 ± 14 years; 61 % women) and 100 hematologists (mean age 42 ± 12 years; 85 % women) from 37 medical centers in 8 Federal districts of the Russian Federation participated in the study. All the patients filled out symptom assessment tool (MPN10), QoL questionnaire for patients with hematological nancies (HM-PRO) and patient's survey checklist; physicians filled out physician's survey checklist and patient record for each patient included in the study. Results. For the first time in Russia in a representative population of MPN patients in the real-world setting, QoL and symptom profiles in patients with different MPNs were characterized and symptom impact on the daily living of MPN patients was identified. MPN patients exhibited QoL impairment: noticeable detriments in physical and emotional functioning, as well as in eating and drinking regimen were found, social functioning was less impaired. More than one third of MPN patients had significant QoL impairment. The vast majority of patients experienced fatigue: 92.6 % MF patients, 83.7 % PI patients, and 82 % ET patients. Symptom prevalence severity differed across different MPNs. Top disease-related symptoms to be resolved were identified from patient's and physician's perspective. Discrepancies in the attitudes of MPN patients and their treating physicians to various aspects regarding the disease and its treatment were found as well as issues needed to be improved in the patient-physician communication were identified. Conclusion. The results of national research program MPN-QoL-2020 allowed to identify the areas of QoL impairment and symptom burden in MPN patients in Russia, to verify areas of concern related to the disease and its treatment in patients with different MPNs, as well as to highlight the unmet needs in this patients' population in our country. The outcomes of the study may contribute to establishing recommendations for improving/maintaining QoL in patients with MPNs and to developing measures aimed to raise awareness of this patients' population about the disease and its treatment.

Comparison of the Quality of Life and Emotional Responses in Kidney Transplant Recipients from Living and Deceased Donors in Nephrology Clinics

Background: Quality of life (QoL) is one of the essential measures in assessing a patient's status after kidney transplant, and emotional response is an important factor in evaluating the patient’s compatibility with the transplant. Also, emotional response affects a patient’s QoL. Objectives: This study aimed to compare the QoL and emotional responses of kidney recipients from deceased and living donors. Methods: This descriptive comparative study randomly selected 118 kidney transplant patients (67 recipients from living donors and 51 recipients from deceased) referred to the Nephrology Clinic of Tehran University of Medical Sciences for a post-surgery follow-up. The QoL questionnaire for patients with renal transplants introduced by Laupacis et al. and the emotional response questionnaire (ERQ) by Ziegelmann et al. were used in this study. For data analysis, Mann-Whitney, independent t-test, and Pearson’s correlation tests were used. All the analyses were performed using SPSS software version 20. Results: The kidney recipients from living donors had significantly higher QoL score (especially emotionally) compared with kidney recipients from deceased donors (P=0.04). The score of emotional response was higher in recipients from a living donor, which is related to feeling guilty, transplant disclosure. Furthermore, recipients from a living donor felt guiltier and were unwilling to disclose their transplant compared with recipients from deceased donors. Conclusions: Feeling of guilt and being anxious about transplant disclosure were higher in recipients from living donors. A significant difference was observed in the QoL and emotional response between the two groups of kidney recipients. Therefore, it is important to involve the transplant team, specifically nurses, in the identification of emotional response and planning accordingly to improve the patients’ QoL, especially in recipients from a living donor.

Psychometric properties of quality of life questionnaires for patients with breast cancer-related lymphedema: A protocol for a systematic review.

Background:Breast-cancer related lymphedema (BCRL) is a common condition among breast cancer survivors that could impact the quality of life (QoL) of patients. Exploring the QoL of the patients with BCRL using valid and reliable QoL is crucial to capture the status of this important aspect hence appropriate intervention could be implement to patient. However, so far no scientific review is available, which reports the psychometric properties of the QoL questionnaires used in BCRL. The purpose of this systematic review is to comprehensively assess the psychometric properties of QoL questionnaires in patients with BCRL.Methods:We will perform comprehensive searches of published studies in electronic databases such as Medline (via Ovid), EBSCOhost, PubMed, Scopus, and Web of Science by using the following search terms: “quality of life”; “breast cancer”; “upper limb”; “lymphedema”; “questionnaire”; and “measurement properties.” Only full-text articles in English language are included. Two reviewers will independently conduct the article selection, data extraction, and quality assessment. Any possible conflict between the 2 reviewers is going to be solved with the help of a third reviewer. The Consensus-based Standards for the Selection of Health Measurement Instrument (COSMIN) checklist and manual will be used to assess the selected study quality.Results:This review will provide an updated overview of available lymphedema-specific questionnaires used in BCRL population and then recommend the most valid and reliable QoL questionnaire for clinical and research use in patients with BCRL.Conclusion:This review may help the clinician and researcher to find an updated overview of various questionnaires used to assess BCRL patients’ QoL.Ethics and dissemination:This review will use data from published studies. Therefore, ethical approval is not required prior to this review. The results of this review will be published in a peer-reviewed journal or presented at conferences.Study Registration:OSF osf.io/8xwym.

Effect of Family-Based Education on the Quality of Life of Persons With Type 2 Diabetes: A Randomized Clinical Trial.

Diabetes, a disease with increasing prevalence, requires comprehensive support from family members to ensure that sufferers are able to perform daily activities. The chronic nature of diabetes and its potential side effects impose high financial costs on patients and families, reduce their quality of life (QOL), and change the lifestyle of both patients and their families. The aim of this study was to investigate the effects of a family-based training program on QOL in persons with Type 2 diabetes. A randomized clinical trial was used to assess the effects of an educational program on QOL both before and after 12 weeks of training for the experimental group (40 patients and families) and of standard care for the control group (40 patients) at an endocrinology clinic in a hospital in Iran. A demographic and social questionnaire and the QOL questionnaire for patients with Type 2 diabetes were used for data collection. The study groups were selected using block randomization sampling, and results were analyzed using descriptive and inferential statistics. Both the experimental and control groups were homogeneousin terms of demographic characteristics and QOL before the intervention. The results of the mean score of patient QOL after the 12-week training program showed a significant difference between the scores for the two groups of patients in the physical, mental, social, economic, disease, and treatment dimensions. Moreover, the total score and QOL of the experimental group improved significantly after the patients' families had attended the training program. Educating the families of patients was shown in this study to improve the QOL of the patient. The design of educational programs for nursing students must emphasize the role of the family in the care of chronic patients.

Quality of Life Questionnaires in Breast Cancer-Related Lymphedema Patients: Review of the Literature.

Lymphedema of the arm is one of the most common and underestimated side effects of breast cancer treatment. It is known to negatively affect the quality of life (QoL) in breast cancer survivors. However, there are multiple questionnaires used to measure QoL in lymphedema patients. The current study aimed to determine the most complete and accurate questionnaire. A systematic literature search in Cochrane Library database CENTRAL, MEDLINE, and EMBASE was conducted in August 2016 by two independent researchers. The strategy used for the search was: (("Lymphedema"[Mesh]) AND ("Quality of life"[Mesh])). All QoL questionnaires for patients with breast cancer-related lymphedema (BCRL) were included. An overview of the assessed QoL domains and arm symptom-specific questions was made, to assess the most complete and accurate questionnaire. A total of 142 studies were identified, of which 49 met the inclusion criteria and 15 different questionnaires were extracted. The Lymphedema Quality of Life Inventory (LyQLI), assesses all QoL domains, except for the possibility of wearing the clothes of choice, and assess all specific arm symptoms. The Lymphedema Functioning, Disability, and Health (Lymph-ICF) Questionnaire assesses all QoL domains, except for sexual functioning, and does assess all specific arm symptoms. According to the results obtained, the LyQLI and Lymph-ICF questionnaires were the two most complete and accurate questionnaires to assess QoL in patients with BCRL, because these questionnaires assess the largest number of QoL domains and specific arm symptoms.

Modernizing quality of life assessment: development of a multidimensional computerized adaptive questionnaire for patients with schizophrenia.

Quality of life (QoL) is still assessed using paper-based and fixed-length questionnaires, which is one reason why QoL measurements have not been routinely implemented in clinical practice. Providing new QoL measures that combine computer technology with modern measurement theory may enhance their clinical use. The aim of this study was to develop a QoL multidimensional computerized adaptive test (MCAT), the SQoL-MCAT, from the fixed-length SQoL questionnaire for patients with schizophrenia. In this multicentre cross-sectional study, we collected sociodemographic information, clinical characteristics (i.e., duration of illness, the PANSS, and the Calgary Depression Scale), and quality of life (i.e., SQoL). The development of the SQoL-CAT was divided into three stages: (1) multidimensional item response theory (MIRT) analysis, (2) multidimensional computerized adaptive test (MCAT) simulations with analyses of accuracy and precision, and (3) external validity. Five hundred and seventeen patients participated in this study. The MIRT analysis found that all items displayed good fit with the multidimensional graded response model, with satisfactory reliability for each dimension. The SQoL-MCAT was 39% shorter than the fixed-length SQoL questionnaire and had satisfactory accuracy (levels of correlation >0.9) and precision (standard error of measurement <0.55 and root mean square error <0.3). External validity was confirmed via correlations between the SQoL-MCAT dimension scores and symptomatology scores. The SQoL-MCAT is the first computerized adaptive QoL questionnaire for patients with schizophrenia. Tailored for patient characteristics and significantly shorter than the paper-based version, the SQoL-MCAT may improve the feasibility of assessing QoL in clinical practice.

How could patient reported outcomes improve patient management in chronic myeloid leukemia?

ABSTRACTIntroduction: Patients reported outcome (PRO) are still under-used in patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKIs), though data on the correlation between quality of life (QoL) and therapeutic efficacy are increasingly known. Chronic low-grade toxicities can reduce patient’s QoL and negatively impact on adherence.Areas covered: This review will focus on the role of QoL questionnaires in patients with CML, receiving imatinib or newer TKIs (dasatinib, nilotinib, bosutinib, ponatinib). Physicians tend to underestimate the impact of TKI-related symptoms, in particular fatigue, that negatively affect QoL and can be a reason of poor adherence to therapy, with detrimental effect on long-term response. Few studies pointed out the role of PRO in CML, and there is paucity of questionnaires specifically designed for CML patients.Expert commentary: We recommend a wider use of PRO to join the pursuit of a rapid and deep responses with an optimization of QoL.

Factors Associated With Quality of Life in Patients With Diabetic Foot Ulcers

Background: Diabetic foot ulcer (DFU) is a serious and costly complication in diabetes which affects approximately 15% of patients with diabetes and affects their quality of life (QOL). Objectives: The purpose of this study was to investigate the factors associated with QOL in patients with DFU. Patients and Methods: This cross-sectional study was performed on 60 patients (32 males and 28 females) hospitalized for DFU, performed through convenience sampling. Data related factors and the QOL questionnaire for patients with DFU were abridged. This questionnaire has 29 questions in six dimensions of enjoying life, physical health, daily activities dependence, negative emotions, concern about wound, and wound caring, which evaluate the QOL in patients with DFU. The scoring method for this tool is five optional Likert. Descriptive and analytic statistical methods were used to analyze the data. Results: Of the 60 patients with DFU, 53% were male and 47% female with an average age of 58.08 ± 11.95 years and average QOL of 41.1 ± 9.15. Statistical analysis showed that age (P = 0.002), employment (P ≤ 0001), socioeconomic status (P = 0.016), leg ulcer (P ≤ 0001), and the number of foot ulcer (P = 0.017) had a statistically significant relationship with QOL and its dimensions. Other variables did not have a significant relationship with QOL, but some of them such as smoking during negative emotions (P = 0.046) and marital status affecting the foot care difficulties (P = 0.03) had significant statistical relationships with QOL. Conclusions: Diabetic foot ulcer affects different aspects of life and can reduce patient’s QOL. To improve the care behaviors and have a better control of foot ulcers and improve the QOL for these patients, taking into account factors such as age, occupation, marital status, number of wounds, and economic status is essential to plan for care and health needs in these patients.

Histopathologic parameters in chronic rhinosinusitis with nasal polyposis: impact on quality of life outcomes

Chronic rhinosinusitis (CRS) is a common disease with a significant impact on health-related quality of life (QOL) of the patient. Histologic inflammatory markers in CRS are an important marker in determining the severity of the disease. In this study, we evaluated the association of histopathologic parameters with QOL questionnaires in patients with CRS with nasal polyposis after endoscopic sinus surgery (ESS). A total of 57 patients were included in this study. Preoperative patient characteristics, clinical findings, and computed tomography scores were recorded. Two QOL measures, the Rhinosinusitis Disability Index (RSDI) and Short Form-36 General Health Survey (SF-36) were analyzed preoperatively and postoperatively. Sinus mucosal specimens were collected at the time of surgery. Presence of the inflammation was evaluated with cellular (eosinophils, neutrophils, lymphocytes, mast cells, macrophages), epithelial (basement membrane thickness [BMT], goblet cell) and stromal markers (subepithelial edema). The histopathological findings were compared statistically with the QOL measures. In comparison of the absolute change of the RSDI and SF-36 scores with mucosal eosinophilia, patients with eosinophilia showed significantly less improvement only in the SF-36 physical functioning subscale (p = 0.004). There was a statistically significant relationship between BMT and RSDI total (p = 0.042), emotional scores (p = 0.003), SF-36 general health (p = 0.032), SF-36 physical function (p = 0.007), SF-36 bodily pain (p = 0.044), and SF-36 mental health (p = 0.022). For most patients QOL significantly improved after surgery. Mucosal eosinophilia did not correlate with the absolute change of the RSDI. However, thickening of basal membrane adversely affects symptoms of the patients and correlates with the disease severity.

Quality of Life Following Amputation or Limb Preservation in Patients with Lower Extremity Bone Sarcoma

Purpose: Although functional differences have been described between patients with lower extremity bone sarcoma with amputation and limb-preservation surgery, differences have not clearly been shown between the two groups related to quality of life. The purpose of the study was to determine if there is a difference in overall quality of life in lower extremity bone sarcoma survivors related to whether they had an amputation or a limb-preservation procedure while identifying psychological differences for further evaluation. The main hypothesis was that sparing a person’s limb, as opposed to amputating it, would result in a better quality of life.Patients and Methods: Eighty-two long-term survivors of lower extremity bone sarcoma were studied to make a comparison of the overall quality of life, pain assessment, and psychological evaluations in limb preservation and amputation patients. Forty-eight patients with limb preservation and thirty-four patients with amputations were enrolled in the study. Validated psychometric measures including the Quality of Life Questionnaire (QLQ), the Minnesota Multiphasic Personality Inventory, and visual analog scales were utilized.Results: The overall quality of life of patients with limb preservation was significantly higher than patients with amputation (p-value < 0.01). Significant differences were noted in the categories of material well-being, job satisfiers, and occupational relations.Conclusion: The overall quality of life of patients with limb-preservation appears to be better than for those patients with amputation based on the QLQ in patients surviving lower extremity bone sarcoma. Further analysis needs to verify the results and focus on the categories that significantly affect the overall quality of life.

Development and validation of a multidimensional quality of life questionnaire for congenital aural atresia

Conclusion: The psychometric characteristics of the Congenital Aural Atresia Questionnaire (CAAQ) are proposed to be reliable and sensitive to determine clinical changes in a patient's quality of life (QOL) and the questionnaire has potential for clinical application. Objective: The aim of this study was to develop a quantifiable, self-assessed, and health-related QOL questionnaire for patients with congenital aural atresia and to explore its reliability and validity. Methods: An initial QOL questionnaire for patients with congenital aural atresia was constructed according to widely used available QOL questionnaires. A total of 140 patients with congenital aural atresia were recruited into this study. After pretest and item sifting, the QOL questionnaire was constructed, and its reliability and validity were evaluated. Results: An 18-item QOL questionnaire for patients with congenital aural atresia was constructed, which included 3 principal domains: symptoms and impact (physical, 8 items), mental status (psychological, 6 items), and social interaction (4 items). The retest reliability was 0.878; split-half reliability coefficient and Cronbach's alpha coefficient were 0.927 and 0.899, respectively. The factor analysis results indicated satisfactory construct validity.

Quality of Life in Pediatric Patients Who Underwent Colectomy for Ulcerative Colitis

BACKGROUND: Chronic ulcerative colitis in children can have a negative impact on quality of life (QOL). Prior studies in adults suggest that colectomy leads to improved measures of QOL. AIM: To determine QOL in pediatric patients who underwent colectomy for ulcerative colitis. METHODS: All patients under 20 years of age who underwent colectomy for ulcerative colitis between 1980 and 2005 at UCSF Children's Hospital were recruited. Of 31 patients contacted, 16 completed the validated QOL Questionnaire for patients with inflammatory bowel disease (IBDQ-32; McMaster University in Ontario, Canada) and an additional questionnaire that addressed bowel function and reproductive health. Each question was rated on a scale of 1 (“all of the time”) to 7 (“none of the time”); total scores ranged from 32 to 224, higher scores indicating a better QOL. Data are presented as Mean±SD. RESULTS: Age at the time of diagnosis was 11.2±3.7 (range 3 to 16) years. Age at colectomy was 13.3±3.7 (6 to 19) years. All but 5 had at least one surgery since colectomy; one had 11 surgeries. Twelve patients (75%) reported no increase in frequency of bowel movements. Pouchitis was reported by 9 (56.3%). The survey was administered 8.7±6.2 (2 to 24) years postcolectomy. Total scores were 159.7±43.3 (58 to 210). Two patients (12.5%) had overall IBDQ scores of ≥200, ten (62.5%) had scores of 151-199, two (12.5%) had scores of 101150, and two (12.5%) had scores ≤100. The two patients with scores ≤100 had repeated episodes of pouchitis (16-30 episodes) compared with the other 14 patients (0-3 episodes). Systemic symptoms (fatigue, difficulty sleeping, and maintaining weight) had the lowest scores (4.2±1.9). Social function (attending social engagements, work or school) had the highest scores (5.6±2.0), and 6/16 patients (37.5%) had scores of 7 (maximum) across all social function questions, which was not found for any other system. Patients continuing to have loose bowel movements had the lowest overall scores (3.6±2.2, range 1-7). Patients with no or minimal rectal bleeding had the highest scores (6.5±1.2, range 3-7). Children who underwent colectomy before 14 years of age had higher scores (better QOL), and children diagnosed before 12 years of age had better QOL than children diagnosed at age ≥12 years (QOL: 5.5±1.0 vs 4.3±1.6). QOL relating to sexual function was highly rated (5.4±2.1; range 2-7). CONCLUSIONS: Measures of QOL in pediatric patients undergoing colectomy for ulcerative colitis show highest QOL scores in social function. Younger age at time of colectomy and of diagnosis, specifically under 12 years of age, leads to greater improvement of QOL. Complications determined by recurrent surgeries or fecal soiling are common, but only pouchitis appears to detract from improved overall QOL.

Adherence to diet and quality of life in patients with phenylketonuria

To investigate adherence to dietary treatment and quality of life (QoL) in patients with phenylketonuria (PKU). In the setting of a tertiary paediatric hospital, 41 early-treated patients affected by PKU aged more than 3 years old were enrolled in a cross-sectional study. Three-days dietary assessment, QoL questionnaires for patients<18 years old (Child Health Questionnaire) and Short Form for adults were completed. Of 41 patients, 23 (56.1%) were considered adherent to the dietary prescriptions as their phenylalanine intake was less than prescribed. Phenylalanine intake was significantly in excess of prescribed if mothers had a lower level of education. Adherence was not correlated with age. Metabolic control was obtained in 41.5-51.2% of the patients depending on the target. QoL was reduced in children and adolescents. There was no significant correlation between adherence and QoL, except for the domains of Global Health and Family Activities (ρ=0.42 and 0.46, respectively). The overall agreement between adherence and metabolic control varied according to different targets of metabolic control (51.2-65.9%). It is necessary to improve the adherence to diet and the QoL in children and adolescents affected by PKU.

Development and Validation of a Quality-of Life Questionnaire for Patients With Chronic Respiratory Disease (CV-PERC): Preliminary Results

Introduction and Objectives The instruments used to assess quality of life in patients with chronic respiratory difficulties have approached this construct in a limited and partial way. Due to this fact, the present paper aimed at describing the development and validation of the CV-PERC scale contemplating the dimensions of physical, psycho-emotional and social, cognitive, working, sexual functionalities and health perception and wellbeing. Patients and Methods It was built stemming from the Saint George Respiratory Questionnaire and the SF-36, generating new items after a theoretical revision and interviews to patients. The selected items were submitted to expert's judgments (Neumonologists and Health Psychologists) to assess validity, wording and appropriateness of language. The initial 60-item instrument was applied to a sample of 101 patients for item selection and analysis. Lastly, the final 50-item scale was administered to a sample of 255 patients from four hospitals in Caracas, Venezuela, to collect data for reliability and validity analyses. Results A 7-dimension factorial structure was found which explained 62.47% of the total variance (physical functionality, sexual functionality, working functionality, health perception and wellbeing, psychoemotional functionality, cognitive functionality and social functionality). Internal consistency of each dimension and of the total scale was over 0.67. Convergent validity and discriminant coefficients were above 0.64. Conclusions The results provide evidence that the CV-PERC scale is a valid and reliable measure to assess quality of life in asthma and EPOC patients.

Development of a QOL module for head and neck cancer patients with enteral feeding tubes

6153 Background: Head and neck cancer (HNC) patients frequently require enteral feeding (EF) during treatment, but how this affects quality of life (QOL) is unknown. We developed a QOL module for use with existing HNC disease-specific QOL questionnaires in patients with EF tubes. Methods: Literature review and a clinician focus group were used to generate QOL items. Items were formatted as statements rated on a 5 point Likert-type scale. The prototype was pilot tested in 12 HNC patients with current or recent EF tubes. The resulting beta version underwent item reduction in a non-overlapping sample of 36 HNC patients, who indicated the importance of each item. Items were kept if their summary importance scores were ranked above median by the whole group or by Chinese or female minority subgroups. Results: Items from the literature were provided to a focus group representing radiation oncology, interventional radiology, radiation therapy, nursing, and nutrition. Of 41 items generated, after pilot testing 15 were eliminated; 2 items identified by 2 or more patients, and 2 “positive” items suggested by investigators, were added. The item reduction study sample of 36 patients (mean age 57.5) included 20 Caucasian individuals, 9 Chinese, and 7 of other cultural background, with 12 females and 24 males. Cancer sites included nasopharynx (16), oropharynx (9), oral cavity (5), hypopharynx (2), unknown primary (2), larynx (1), and paranasal sinus (1). Overall, 17 items rated above median importance were kept. Among Chinese patients, 2 additional items were kept, and among women 1 additional item was kept. No additional write-in items were identified by 2 or more patients. Conclusions: We have developed a 20 item QOL module for HNC patients with EF tubes. The module is currently undergoing validity and reliability testing in a new sample of 75 patients with EF tubes. This instrument may be useful in trials comparing aggressive treatment strategies for HNC or different methods of EF. No significant financial relationships to disclose.

Development of a QOL module for head and neck cancer patients with enteral feeding tubes

6153 Background: Head and neck cancer (HNC) patients frequently require enteral feeding (EF) during treatment, but how this affects quality of life (QOL) is unknown. We developed a QOL module for use with existing HNC disease-specific QOL questionnaires in patients with EF tubes. Methods: Literature review and a clinician focus group were used to generate QOL items. Items were formatted as statements rated on a 5 point Likert-type scale. The prototype was pilot tested in 12 HNC patients with current or recent EF tubes. The resulting beta version underwent item reduction in a non-overlapping sample of 36 HNC patients, who indicated the importance of each item. Items were kept if their summary importance scores were ranked above median by the whole group or by Chinese or female minority subgroups. Results: Items from the literature were provided to a focus group representing radiation oncology, interventional radiology, radiation therapy, nursing, and nutrition. Of 41 items generated, after pilot testing 15 were eliminated; 2 items identified by 2 or more patients, and 2 “positive” items suggested by investigators, were added. The item reduction study sample of 36 patients (mean age 57.5) included 20 Caucasian individuals, 9 Chinese, and 7 of other cultural background, with 12 females and 24 males. Cancer sites included nasopharynx (16), oropharynx (9), oral cavity (5), hypopharynx (2), unknown primary (2), larynx (1), and paranasal sinus (1). Overall, 17 items rated above median importance were kept. Among Chinese patients, 2 additional items were kept, and among women 1 additional item was kept. No additional write-in items were identified by 2 or more patients. Conclusions: We have developed a 20 item QOL module for HNC patients with EF tubes. The module is currently undergoing validity and reliability testing in a new sample of 75 patients with EF tubes. This instrument may be useful in trials comparing aggressive treatment strategies for HNC or different methods of EF. No significant financial relationships to disclose.