Miracle-dz/UniFAR-FTUs huggingface dataset:
Health and Quality of Life Outcomes

Background: The QUALIOST® was designed for use with the SF-36 to measure established osteoporosis-specific quality of life (QoL). The reliability (internal consistency and test-retest) and validity of the questionnaire were established in a stand-alone psychometric validation study. The objective of this paper is to provide additional information on the instrument's responsiveness using clinical trial data, along with the reliability and validity of translated versions. Methods: The Spinal Osteoporosis Therapeutic Intervention (SOTI) was an international clinical trial comparing strontium ranelate to placebo on the occurrence of new vertebral fracture in patients with postmenopausal osteoporosis. QoL was a secondary endpoint, assessed using the SF-36 and QUALIOST® at baseline and every six months, with the main analysis at 3-year follow-up. Questionnaire acceptability, analysis of the hypothesised structure, internal consistency reliability and responsiveness to clinical change over time were assessed at the 3-year follow up. Results: 1592 patients from 11 countries completed at least one QoL questionnaire. The psychometric properties of the questionnaires were assessed on cross-sectional (N = 1486) and longitudinal (N = 1288) data. Item discriminant validity of the QUALIOST® was excellent, as was item convergent validity, with 100% of item-scale correlations being above the 0.40 level. Internal consistency reliability was also extremely good, with high Cronbach's alpha scores above the 0.70 benchmark. Responsiveness results were consistent for all QUALIOST® scores, indicating that greater decreases in QoL corresponded to greater numbers of fractures experienced. QUALIOST® scores also differed according to the type of fracture suffered. This was demonstrated by increased effect sizes for more severe vertebral fractures (clinical vertebral and painful vertebral). In comparing responsiveness, the QUALIOST® scores were generally more consistent than those of the SF-36. Most notably, the QUALIOST® was more responsive with regard to painful vertebral fractures than the SF-36. Conclusion: The QUALIOST® is a reliable and valid tool for measuring QoL in postmenopausal osteoporotic women. Being available in several validated language versions, it is ready to be used in a variety of settings, including international clinical trials. Published: 10 November 2005 Health and Quality of Life Outcomes 2005, 3:69 doi:10.1186/1477-7525-3-69 Received: 11 May 2005 Accepted: 10 November 2005 This article is available from: http://www.hqlo. com/content/3/1/69 © 2005 de la Loge et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Health and Quality of Life Outcomes

Background: Co-morbidity is a common phenomenon in the elderly and is considered to be a major threat to quality of life (QOL). Knowledge of co-existing conditions or patient characteristics that lead to an increased QOL decline is important for individual care, and for public health purposes. In visually impaired older adults, it remains unclear which co-existing conditions or other characteristics influence their health-related QOL. Our aim was to present a risk profile of characteristics and conditions which predict deterioration of QOL in visually impaired older patients. Methods: Analyses were performed on data from an observational study among 296 visually impaired older patients from four Dutch hospitals. QOL was measured with the EuroQol-5D (EQ-5D) at baseline and at five-month follow-up. Nine co-existing condition categories (musculoskeletal; diabetes; heart; hypertension; chronic obstructive pulmonary disease (COPD) or asthma; hearing impairment; stroke; cancer; gastrointestinal conditions) and six patient characteristics (age; gender; visual acuity; social status; independent living; rehabilitation type) were tested in a linear regression model to determine the risk profile. The model was corrected for baseline EQ-5D scores. In addition, baseline EQ-5D scores were compared with reference scores from a younger visually impaired population and from elderly in the general population. Results: From the 296 patients, 50 (16.9%) were lost to follow-up. Patients who reported diabetes, COPD or asthma, consequences of stroke, musculoskeletal conditions, cancer, gastrointestinal conditions or higher logMAR Visual Acuity values, experienced a lower QOL. After five months, visual acuity, musculoskeletal conditions, COPD/asthma and stroke predicted a decline in QOL (R2 = 0.20). At baseline, the visually impaired older patients more often reported moderate or severe problems on most EQ-5D dimensions than the two reference groups. Conclusion: In visually impaired older patients, visual acuity, musculoskeletal conditions, COPD/asthma and stroke predicted a relatively rapid decline in health-related QOL. With this risk profile, a specific referral by the ophthalmologist to another sub-specialty may have a beneficial effect on the patient's health-related QOL. A referral by the ophthalmologist or optometrist to a multidisciplinary rehabilitation service seems appropriate for some patients with comorbidity. The current results need to be confirmed in studies using pre-structured questionnaires to assess comorbidity. Published: 25 February 2009 Health and Quality of Life Outcomes 2009, 7:18 doi:10.1186/1477-7525-7-18 Received: 15 August 2008 Accepted: 25 February 2009 This article is available from: http://www.hqlo. com/content/7/1/18 © 2009 van Nispen et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Health and Quality of Life Outcomes

Objective: To evaluate the reliability of a one-week versus a four-week recall period of the Medical Outcomes Study Sleep Scale (MOS-SS) in patients with fibromyalgia (FM). Methods: The MOS-SS was administered by mail to patients with a confirmed diagnosis of FM and a current pain rating of > 2 (0–10 point numerical rating scale) recruited through newspapers, support groups, and the Internet. Reliability of MOS-SS subscale domains was evaluated using testretest methodology separated by a 1–3 day interval for the 4-week recall period and a 7-day interval for the 1-week recall period. Patient Impression of Change was evaluated for sleep, and for patients with no change, the intraclass correlation coefficient (ICC) and the Pearson correlation coefficient was calculated for MOS-SS subscales. Results: Of 129 patients enrolled, 91.3% were female, mean age was 49.4 ± 11.0 years; self-rated FM severity was moderate-to-severe in 88.1% of patients. MOS-SS subscale scores were similar for both recall periods with little variation between test-retest. The 9-item Sleep Problems Index scores ranged from 57.2 ± 14.5 to 61.9 ± 15.8 across all assessments and demonstrated high reliability which was similar for the 1-week (ICC 0.81) and 4-week (ICC 0.89) recall periods. For the other MOS-SS subscales, the 1-week recall period also showed good reliability, which was consistent for the ICC and Pearson correlation coefficients. Conclusion: A 1-week recall period is adequately reliable for use of the MOS-SS in studies evaluating sleep disturbance in patients with FM. Although the etiology of fibromyalgia (FM) is uncertain, it is generally diagnosed according to the American College of Rheumatology (ACR) criteria, which include chronic, widespread pain for at least 3 months, and the presence of 11 out of 18 tender points [1]. It has been estimated that approximately 5 million individuals in the U.S. have FM, with a higher prevalence among women (3.4%) than men (0.5%) [2]. In other countries, the prevalence of FM has been estimated to range between 0.5% to 5%, also with a higher prevalence among women [3]. FM is associated with a substantial socioeconomic burden resulting from excess health resource utilization, reductions in productivity and quality of life, and a health status that is poorer than other chronic pain conditions such as rheumatoid arthritis and osteoarthritis [4-7]. This burPublished: 10 February 2009 Health and Quality of Life Outcomes 2009, 7:12 doi:10.1186/1477-7525-7-12 Received: 29 August 2008 Accepted: 10 February 2009 This article is available from: http://www.hqlo. com/content/7/1/12 © 2009 Sadosky et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Health and Quality of Life Outcomes

Background: Local tolerance of topical glaucoma treatment is important to achieve a good compliance. The aim of this study was to evaluate the consequences of local anti-glaucoma drug side effects on the vision-related quality of life (QoL). Methods: A mail survey was sent to 20,000 homes of a panel representative of the French population asking whether one member of the family was suffering from ocular hypertension (OHT) or glaucoma. (POAG) A computer-assisted telephone interviewing system was used to confirm self-reported glaucoma, to describe the disease and its treatment, and medical item consumption. Vision-related QoL was assessed with the NEI-VFQ-25 (National Eye Institute Visual – Function Questionnaire) and local tolerance with the COMTOL (Comparison of Ophthalmic Medications for TOLerability). Results: 13,352 homes (66.7%) answered the mail. 581 people declared they were suffering from glaucoma or OHT. Prevalence was 1.8%, increasing with age. 204 patients were selected at random Their NEI-VFQ-25 global score showed an overall good QoL. Two domain scores showed some deterioration: general health and driving. 62.4% of the patients cited at least one local side effect. 25.4% had burning, 20.8% blurred vision and 20.2% tearing. Poor vision related QoL was associated with the presence of local side effects leading to poor perceived treatment satisfaction. Dissatisfied patients visited their ophthalmologist more frequently. Conclusion: Based on a representative French sample, poor vision related QoL was associated with topical drug side effects that also impact patient satisfaction and compliance. Longitudinal data collection should be performed to confirm our findings. Background Primary open-angle Glaucoma (POAG) is characterised by a progressive alteration of the optic nerve. Glaucoma is one of the three leading causes of blindness in developed Published: 10 December 2003 Health and Quality of Life Outcomes 2003, 1:75 Received: 05 November 2003 Accepted: 10 December 2003 This article is available from: http://www.hqlo. com/content/1/1/75 © 2003 Nordmann et al; licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.
UvA-DARE ( Digital Academic Repository ) Optical spectroscopy of the transient XTE J 1118 + 480 in outburst

We report on optical spectroscopic observations of the X-ray transient XTE J1118]480 covering the period from 2000 April 7 to July 4. The spectrum is characterized by weak, broad, double-peaked Balmer and He lines on top of a blue continuum of slope as expected for an optically thick accrep B 13, tion disk. The weak Bowen blend seen in our spectra may indicate a low metallicity for the source. The presence of a partial S-wave pattern in the He II j4686 line appears consistent with the reported photometric period hr for XTE J1118]480. By using a combination of Doppler mapping and Porb\ 4.1 various theoretical arguments, we constrain plausible orbital parameters for the system: a mass ratio and an inclination for a neutron star primary or for a black hole 0.02[ q [ 0.1 iZ 70¡ 30¡ [ i [ 50¡ primary with a mass between 4 and 10 Ca II absorption features observed at very high resolution M _ . constrain the interstellar hydrogen absorption column and the identiÐcalog [NHI(cm~2)]B 20.45^ 0.2, tion of three absorbing clouds indicate a distance to the source kpc, assuming the line of sight to [1 XTE J1118]480 has average high-latitude properties. These results are discussed in the context of previous multiwavelength observations of this unusual system. Subject headings : accretion, accretion disks È binaries : close È X-rays : stars
Health and Quality of Life Outcomes

Background: In adult quality of life (QOL) research, the QOL construct appears to differ from self-rated health status. Although increased QOL continues to be recognized as an important outcome in health promotion and medical intervention, little research has attempted to explore adolescent perceptual differences between selfrated health and QOL. Methods: Correlational analyses were performed between self-rated health, physical health days and mental health days, and QOL. Data were collected from two different public high school adolescent samples during two different time periods (1997 & 2003) in two different geographic regions in the USA (a southern & midwestern state) with two different sample sizes (N = 5,220 and N = 140, respectively) using the CDC Youth Risk Behavior Survey (YRBS). The Centers for Disease Control and Preventions' health-related quality of life scale (HRQOL) provided estimates of self-rated health, physical health days and mental health days, and QOL. Results: All correlation coefficients were significant in both samples (p ≤ .0001), suggesting sample size was not a contributing factor to the significant correlations. In both samples, adolescent QOL ratings were more strongly correlated with the mean number of poor mental health days (r = .88, southern sample; r = .89, midwestern sample) than with the mean number of poor physical health days (r = .75, southern sample; r = .79, midwestern sample), consistent with adult QOL research. However, correlation coefficients in both samples between selfrated health and the mean number of poor physical health days was slightly smaller (r = .24, southern, r = .32, midwestern) than that between self-rated health and the mean number of poor mental health days (r = .25, southern, r = .39 midwestern), which is contrary to adult QOL research. Conclusion: Similar to adults, these results suggest adolescents are rating two distinct constructs, and that selfrated health and QOL should not be used interchangeably. QOL, in the context of public high school adolescents, is based largely upon self-reported mental health and to a lesser extent on self-reported physical health. Conversely, although self-reported mental health and self-reported physical health both contribute significantly to adolescent self-rated health, mental health appears to make a greater contribution, which is contrary to observations with adults. Health promoting efforts for adolescents may need to focus more on mental health than physical health, when considering population needs and type of micro or macro intervention. Published: 25 October 2005 Health and Quality of Life Outcomes 2005, 3:64 doi:10.1186/1477-7525-3-64 Received: 13 June 2005 Accepted: 25 October 2005 This article is available from: http://www.hqlo. com/content/3/1/64 © 2005 Zullig et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Health and Quality of Life Outcomes

Background: An increasing awareness of the need to address sexual and orgasm experiences as part of life quality and an understanding of the great individual differences between women play roles in women's health and medical care across the specialities. Information is lacking as to how negative attitude toward self (NATS) and performance impairment (PI) are associated with sexual activity of middle-aged women. We examined the associations of sexual experience, orgasm experience, and lack of sexual desire with perceived health and potential explanatory variables of NATS and PI. Methods: Questionnaire was mailed to 2 population-based random samples of menopausal or soon-to-be menopausal women (n = 5510, 70% response) stratified according to age (42–46 and 52–56 years). In multivariate analyses of the associations with the outcome variables, perceived health, NATS, and PI were used as covariates in 6 models in which exercise, menstrual symptoms, and illness indicators were taken into account as well. Results: Sexual activity variables were associated with perceived health. When present, NATS formed associations with sexual and orgasm experiences, whereas strenuous exercise formed associations with orgasm among 42–46-year-old women alone. Strenuous exercise was not associated with orgasm experience among older women. Conclusion: NATS and PI are closely tied to orgasm experiences and the meaning of the roles needs to be exposed. Sexual activity deserves to be addressed more actively in patient contact at least with perimenopausal women. Background Impact of menopause on health or sexuality is still imprecise. Appropriate questions [1] have either not been asked or their outcomes are unclear [2]. Women's health has in part been connected with reproduction and gynaecological issues [3], and many practicing physicians believe that Published: 10 May 2006 Health and Quality of Life Outcomes 2006, 4:29 doi:10.1186/1477-7525-4-29 Received: 19 December 2005 Accepted: 10 May 2006 This article is available from: http://www.hqlo. com/content/4/1/29 © 2006 Ojanlatva et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Health and Quality of Life Outcomes

I believe that the FDA guidelines have already had an impact in encouraging good practice in the use of PROs. There are, however, important improvements that need to be made to the guidelines, particularly in the use of health status and quality of life terminology. It is essential to distinguish between health status and quality of life and to use both terms. Nothing is to be gained and a great deal will be lost if the term quality of life (which has been misused as an umbrella term in the past) is abandoned and replaced with the term health status. Patients want us to consider their quality of life as well as their health. To abandon the term would be to forget about their quality of life and focus only on their health. Patients are well able to tell us what quality of life means to them and to rate the impact of a condition on their quality of life if we use individualised quality of life measures and individualised condition-specific quality of life measures to allow them to do so. Although my experience with PRO measures would support many of the recommendations in the guidelines there are others that I would not fully agree with or would contradict on the basis of my own research evidence. I have provided references to that research and hope that the FDA will feel able to do the same when they finalise their guidelines. Introduction The US Department of Health and Human Services Food and Drug Administration (FDA) made public in February 2006 a document entitled 'Guidance for Industry PatientReported Outcome Measures: Use in Medical Product Development to Support Labeling Claims DRAFT GUIDANCE'. I have a particular interest in this draft guidance as I specialise in the design, development and use of PRO measures and license them for use in clinical trials, other research and routine clinical practice. My measures include: • the Diabetes Treatment Satisfaction Questionnaire (DTSQ) in its status (DTSQs) and change (DTSQc) forms [1-6] and related measures for other conditions including the HIVTSQ, RTSQ, RetTSQ, GHerpTSQ, ThyTSQ [7-12], and the newly designed DTSQ-Teen and DTSQ-Parent. The DTSQs and DTSQc are fully linguistically validated in 65 language versions • the Well-being Questionnaire (e.g. W-BQ12) [3,13-18] generic measure of well-being is psychometrically validated for a range of populations including those who have diabetes (type 1 and type 2) macular disease and Published: 09 October 2006 Health and Quality of Life Outcomes 2006, 4:78 doi:10.1186/1477-7525-4-78 Received: 19 July 2006 Accepted: 09 October 2006 This article is available from: http://www.hqlo. com/content/4/1/78 © 2006 Bradley; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Role of Diffusion-Weighted Magnetic Resonance Imaging (DWMRI) in Assessment of Primary Penile Tumor Characteristics and Its Correlations With Inguinal Lymph Node Metastasis: A Prospective Study

Background Penile cancer is a rare malignancy. The extent of lymph node (LN) metastasis is the most important prognostic factor in penile cancer. However, preoperative prediction of LN involvement in clinically non-palpable LN is still a challenge. In absence of a reliable biomarker, attempts are being made to validate imaging characteristics as a predictive tool. The aim of the present study is to assess the primary penile tumor characteristics with diffusion-weighted magnetic resonance imaging (DWMRI) and its correlations with inguinal LN status and tumor positivity in LN dissection specimen within normal sized LNs. Methods Twenty-six patients with carcinoma penis underwent DWMRI of penis and pelvis. The apparent diffusion coefficient (ADC) values of primary tumor were compared with histological characteristics. Inclusion criteria encompassed all cases of clinically non-palpable inguinal LN and normal sized LN on imaging. All palpable inguinal nodes with pelvic lymphadenopathies were excluded from this study. Results The primary tumor ADC ranged from 0.65 × 10-3 - 1.2 × 10-3 mm2/s (mean: 0.87 × 10-3 ± 0.11 × 10-3 mm2/s). In pT1 and pT3 tumors, mean ADC values were 0.86 × 10-3 ± 0.10 × 10-3 and 0.81 × 103 ± 0.09 × 103 mm2/s, respectively. The mean ADC values for grade 1, grade 2 and grade 3 were 0.89 × 10-3, 0.82 × 10-3 and 0.80 × 10-3 mm2/s, respectively. The ADC value of < 0.95 × 10-3 mm2/s was positively correlated with pathological LN presence within normal sized LN. With mean ADC value of 0.87 × 10-3 ± 0.11 × 10-3 mm2/s, sensitivity and positive predictive values for primary penile cancer were 100% and 84.61%, respectively. The mean ADC value for higher-grade and -stage tumor was low. The sensitivity and specificity of predicting LN metastasis by DWMRI were 87.22% and 80.90%, respectively. Conclusion ADC value of primary tumor can help in prediction of LN metastasis in carcinoma penis with clinically and radiologically normal groin.