How French subjects describe well-being from food and eating habits? Development, item reduction and scoring definition of the Well-Being related to Food Questionnaire (Well-BFQ©).

Providing well-being and maintaining good health are main objectives subjects seek from diet. This manuscript describes the development and preliminary validation of an instrument assessing well-being associated with food and eating habits in a general healthy population. Qualitative data from 12 groups of discussion (102 subjects) conducted with healthy subjects were used to develop the core of the Well-being related to Food Questionnaire (Well-BFQ). Twelve other groups of discussion with subjects with joint (n = 34), digestive (n = 32) or repetitive infection complaints (n = 30) were performed to develop items specific to these complaints. Five main themes emerged from the discussions and formed the modular backbone of the questionnaire: "Grocery shopping", "Cooking", "Dining places", "Commensality", "Eating and drinking". Each module has a common structure: items about subject's food behavior and items about immediate and short-term benefits. An additional theme - "Eating habits and health" - assesses subjects' beliefs about expected benefits of food and eating habits on health, disease prevention and protection, and quality of ageing. A preliminary validation was conducted with 444 subjects with balanced diet; non-balanced diet; and standard diet. The structure of the questionnaire was further determined using principal component analyses exploratory factor analyses, with confirmation of the sub-sections food behaviors, immediate benefits (pleasure, security, relaxation), direct short-term benefits (digestion and satiety, energy and psychology), and deferred long-term benefits (eating habits and health). Thirty-three subscales and 14 single items were further defined. Confirmatory analyses confirmed the structure, with overall moderate to excellent convergent and divergent validity and internal consistency reliability. The Well-BFQ is a unique, modular tool that comprehensively assesses the full picture of well-being related to food and eating habits in the general population.

Development and psychometric validation of the REFlective evaLuation of psoriasis Efficacy of Treatment and Severity (REFLETS) questionnaire: a common measure of plaque-type psoriasis severity and treatment efficacy for patients and clinicians.

BACKGROUND: To date, there is no global consensus on the definition of the severity of psoriasis. The REFlective evaLuation of psoriasis Efficacy of Treatment and Severity (REFLETS) questionnaire has recently been developed to provide a better understanding of plaque-type psoriasis severity and treatment efficacy from both patient and clinician perspectives. OBJECTIVE: This study aimed to develop and psychometrically validate the new REFLETS questionnaire to evaluate patient and clinician perceptions of plaque-type psoriasis severity and treatment efficacy. METHODS: Two similar versions of the REFLETS questionnaire were developed following a rigorous methodology for clinicians and patients, referring to 'the psoriasis of your patient' or to 'your psoriasis', respectively. An observational, longitudinal, multicentre study was conducted in France with 34 dermatologists and 430 mild to severe plaque-type psoriasis patients to finalize the questionnaire and evaluate its psychometric properties. RESULTS: Two dimensions were defined--severity and treatment efficacy--with three subdimensions within severity (impact of psoriasis, symptoms and disease course), and two individual items on joint pain. The questionnaire was well accepted by clinicians and patients. Excellent internal consistency (Cronbach's alpha = 0.66-0.98) and test-retest reliability (intraclass correlation coefficients = 0.83-0.94) were demonstrated. REFLETS scores were moderately to highly correlated to Psoriasis Area and Severity Index (r = 0.35-0.70), Skindex-29 (r = 0.46-0.82) and DLQI scores (r = 0.36-0.82). Patients with decreased psoriasis severity and those with increased treatment efficacy, according to patient global evaluations, had lower severity and higher treatment efficacy REFLETS scores, respectively. CONCLUSION: REFlective evaLuation of psoriasis Efficacy of Treatment and Severity is a promising tool for assessing plaque-type psoriasis severity and treatment efficacy from patient and clinician perspectives. It may help to improve patient and clinician communication in treatment decision making.

Validation of the adherence evaluation of osteoporosis treatment (ADEOS) questionnaire for osteoporotic post-menopausal women.

SUMMARY: We developed and validated a specific 12-item questionnaire to evaluate adherence to oral antiresorptive medication by post-menopausal osteoporotic women in everyday practice. Over the following 9 months, an index of ≤16 was associated with an increase in the risk of treatment discontinuation of 1.69 and of 2.10 for new patients who had started treatment within the previous year. INTRODUCTION: Adherence to medication in osteoporosis is poor. The goal of this study was to develop and validate a disease-specific questionnaire to evaluate adherence to treatment of women with post-menopausal osteoporosis taking oral antiresorptive medication. METHODS: A prototype adherence questionnaire with 45 items developed from patient interview, literature review, and physician opinion was evaluated in a sample of 350 post-menopausal women with osteoporosis treated in primary care. Item responses were matched against scores on the Morisky Medication Adherence Scale (MMAS). The most discriminant items were retained in the final questionnaire. Concurrent and predictive validity were assessed. RESULTS: Twelve items were associated with MMAS score at a probability level of 0.05. These were retained in the final questionnaire which provided an adherence index ranging from 0 to 22. An index of ≥20 was associated with a high probability of persistence and an index ≤ 16 with a high probability of treatment discontinuation in the following 9 months. CONCLUSIONS: The ADEOS-12 is a simple patient-reported measure to determine adherence to osteoporosis treatments with good concurrent and discriminant validity. This is the first disease-specific adherence measure to have been developed for osteoporosis.

Assessment of the severity of infant crying and its impact on parents: Development and validation of the ColiQ Questionnaire in France.

OBJECTIVES: The purpose of this study was to develop and validate a questionnaire that comprehensively assesses symptoms and severity of crying, symptoms suggesting infant functional gastrointestinal discomfort, and its impact on parents' quality of life: the Infant Colic Questionnaire (ColiQ©). For the first time, parents had access to a web application to follow their infants' evolving symptoms with a daily questionnaire. METHODS: The ColiQ was developed with a board of clinical experts (physicians and psychologists) based on extensive parent input. A longitudinal, observational study was conducted in France for 3 months. ColiQ assessments were collected online at six different time points. Psychometric testing demonstrated that ColiQ has acceptable psychometric properties (reliability, internal consistency, construct validity, and responsiveness). RESULTS: The ColiQ is a 16-question instrument developed in French including ten questions describing symptoms (Infant score) and six questions describing impacts (Parent score). The ColiQ demonstrated good test-retest reliability (ICC >0.70), internal consistency for both the Symptom and Impact subscale scores (Cronbach's α >0.70), and construct validity. Responsiveness was good; the ColiQ was able to detect significant improvement in the target population as early as 1 month (p<0.05). The global ColiQ score discriminated between severity levels (mild, medium, severe). CONCLUSIONS: The ColiQ was developed with input from parents and healthcare professionals and has shown validity, reliably, and responsiveness to change. Parents can use the web application to follow how their infants' symptoms evolve. The ColiQ can help parents quantify and verbalize their concerns during consultations, and provides an opportunity to facilitate conversations between the physician and parents.

Management of lung cancer patients' quality of life in clinical practice: a Delphi study.

BACKGROUND: The assessment of health-related quality of life (HRQoL) has seen exponential growth in oncology clinical trials. However, the measurement of HRQoL has yet to be optimised in routine clinical practice. This study aimed at exploring the operationalisation of HRQoL in clinical practice with the goal of reaching a consensus from a panel of physicians. MATERIALS AND METHODS: Physicians involved in the management of lung cancer patients in France were recruited to participate in a Delphi study. The study involved three rounds of iterated queries to gain consensus on management aspects of HRQoL, including timing of discussion on HRQoL, which specific domains of HRQoL should be discussed, and what was the most appropriate method of assessment. The threshold adopted for consensus was at least 70% agreement among physicians. A scientific committee reviewed results following each round of the Delphi study. RESULTS: A representative panel of 60 physicians participated in this study. Consensus was obtained for HRQoL management at all time points in the patient care pathway. Panellists agreed that HRQoL discussions should occur during routine visits and hospitalisation. The involvement of patients' relatives was also recognised as important, except when discussing side-effects and involvement of a multidisciplinary team. There was a lack of consensus on a systematic assessment for all patients at each visit and no consensus on how HRQoL should be measured in clinical practice. CONCLUSIONS: HRQoL discussions are considered an integral part in the management of lung cancer patients, and are deemed key to success in patient-physician interaction. Further research is required to harmonise how best to implement HRQoL assessment.

Development of the Fibromyalgia Burden Assessment: measuring the multifaceted burden of fibromyalgia.

OBJECTIVES: To develop a questionnaire assessing the burden of fibromyalgia's impacts on patients' lives. METHODS: A literature review was conducted to identify impacts of fibromyalgia and their consequences on patients' lives. Exploratory interviews were performed with 15 fibromyalgia patients in France, Germany and Spain. Using patients' wording, items were generated simultaneously in French, German, Spanish, and UK English. Relevance and comprehension of the resulting questionnaire versions were tested with 21 additional fibromyalgia patients; questionnaires were revised accordingly. RESULTS: Three domains, Burden associated with the impacts of fibromyalgia, Symptoms and Influencing factors, were identified from the literature review. Following patient interviews, the burden domain was further divided based on the nature of the impact: Pain, Physical impact (including tiredness, sleep problems and other symptoms), Activities of Daily Living impact (including autonomy and coping), Social and Family Life impact, Work, Studies and Personal Finances impact, Psychological impact (including cognitive impact), and Relationship to Medicine and Disease. The resulting test versions of the questionnaire contained 79 items. Comprehension tests identified problematic items and cultural differences and suggested deletions or rewording. After revision and linguistic harmonization, the pilot version of the questionnaire contained 62 items divided into 7 sections, and was named Fibromyalgia Burden Assessment (FMBA©). CONCLUSIONS: The FMBA is a self-reported questionnaire allowing the assessment and a better understanding of the impacts of fibromyalgia and the burden associated with these on patients' daily lives. It is available in UK English, French, German and Spanish. Its scoring and validation remain to be undertaken.

Simplification and first validation of a short battery of patient questionnaires for clinical management of HIV-infected patients: The HIV-SQUAD (Symptom Quality of life Adherence) Questionnaire.

PURPOSE: Questionnaires assessing patient-reported outcomes in HIV are either too long or not HIV-specific. Our aim was to develop and validate a simplified HIV patient questionnaire. METHOD: 607 HIV patients treated with a combination of antiretroviral (ARV) drugs were enrolled in an observational, longitudinal study. Questionnaires covering health-related quality of life (HRQoL), satisfaction, tolerability, and adherence were administered at baseline (BL) and Month 3 (M3). The items were selected according to their content and discriminant properties. The simplified questionnaire was then administered at Month 12 (M12). Psychometric properties of physical wellbeing, psychological well-being, and global HRQoL scores were assessed. RESULTS: The simplified questionnaire included 12 HRQoL items, 13 side-effects items, and one visual analog scale (VAS) measuring adherence. The principal component analysis (PCA) confirmed the validity of the global HRQoL score. The multivariate analysis showed acceptable-to-good internal consistency of the three scores. Convergent and discriminant validity were excellent for the physical score. The global score showed significant differences according to time since diagnosis, hepatitis coinfection, CD4 count, and viral load. CONCLUSION: This questionnaire deals with the major aspects of HIV patient perceptions. The global HRQoL score is well correlated to the surrogate markers of HIV. Such a questionnaire may represent a new tool for the therapeutic management of HIV-infected patients. Further steps are required to complete these results.

painPREDICT: first interim data from the development of a new patient-reported pain questionnaire to predict treatment response using sensory symptom profiles.

Objective: Sensory symptom patterns may be useful for predicting treatment response, and, thus, improve individual therapy in patients suffering from neuropathic pain (NeP). Existing screening questionnaires focus predominately on neuropathic mechanisms without consideration of nociceptive mechanisms or mixed pain states. This study aimed to develop a new questionnaire, painPREDICT, using a wide set of patient-reported descriptors potentially associated with neuropathic and nociceptive pain mechanisms, and to explore sensory symptom patterns. Methods: PainPREDICT was constructed based on exploratory (n = 27 patients) and cognitive debriefing interviews (n = 49 patients and nine physicians), across five NeP conditions. The pilot questionnaire was then administered in a non-interventional, cross-sectional, multi-center study to 840 pain patients across the US and Germany. The identification of a sensory symptom pattern was based on hybrid clustering resulting from items standardization followed by principal component analysis. Results: The final questionnaire included 20 items covering: pain intensity, location of pain, course of pain, and sensory symptoms. Most patients participating in the cross-sectional study suffered either from painful diabetic polyneuropathy (n = 330) or radiculopathy (n = 349), fewer from central pain (n = 61) or other types of NeP (n = 100). The hybrid clustering of the new questionnaire data identified three different characteristic sensory symptom profiles in patients with NeP: "Irritable nociceptors", "deafferentation pain", and "pain attacks with nociceptive component". Although some differences in the distribution of the sensory profiles were found, all profiles were represented in all NeP etiology groups. Conclusions: This study set the ground of painPREDICT and showed promising results for its use to categorize patients according to sensory symptom patterns.

Prospective longitudinal study on quality of life in relapsed/refractory multiple myeloma patients receiving second- or third-line lenalidomide or bortezomib treatment.

Treatment advances for multiple myeloma (MM) that have prolonged survival emphasise the importance of measuring patients' health-related quality of life (HRQoL) in clinical studies. HRQoL/functioning and symptoms of patients with relapsed/refractory MM (RRMM) receiving second- or third-line lenalidomide or bortezomib treatment were measured in a prospective European multicentre, observational study at different time points. At baseline, patients in the lenalidomide cohort were frailer than in the bortezomib cohort with more rapid disease progression at study entry (more patients with Eastern Cooperative Oncology Group performance status >2, shorter time from diagnosis, more chronic heart failure, higher serum creatinine levels, more patients with dialysis required). About 40% of the patients receiving lenalidomide discontinued the study in <6 months while 55% in the bortezomib cohort discontinued. No substantial HRQoL deterioration was observed for the first 6 months in patients with RRMM receiving one or the other treatment. For patients still on treatment at study completion (month 6), only the European Organization for Research and Treatment of Cancer Quality-of-Life Core domains of Diarrhoea and Global Health Status/QoL had worsened in the lenalidomide and bortezomib cohorts, respectively. A clinically meaningful deterioration in HRQoL was more often observed for patients who discontinued the study prior to 6 months in the bortezomib cohort than in the lenalidomide cohort.

Quality of Sexual Life Questionnaire (QVS): a reliable, sensitive and reproducible instrument to assess quality of life in subjects with erectile dysfunction.

A French quality of life questionnaire specific to erectile dysfunction (ED), 'QVS' for 'Questionnaire de Vie Sexuelle', has been developed. This paper describes its validation: item reduction and reliability (internal consistency and reproducibility), construct validity and criterion validity (clinical, discriminant and concurrent). The initial 40-item questionnaire was administered once to 316 ED and 117 control subjects, and twice (D0 and D7) to 104 ED and 29 control subjects. Item reduction gave a 27-item questionnaire with three scales (Sexual Life, Skills and Psychosocial Well-being) and four scores (one score for each scale and a Global Index). Psychometric analyses demonstrated the reliability and the validity of the QVS. The questionnaire was able to discriminate patients according to the presence or severity of ED. The Skills scale was the least sensitive. Analysis of responsiveness to change over time still needs to be addressed to consider the questionnaire as a fully validated instrument.

Optic pathway glioma infiltrating into somatostatinergic pathways in a young boy with gigantism. Case report.

The authors report gigantism in a 16-month-old boy with an extensive optic pathway glioma infiltrating into somatostatinergic pathways, as revealed by magnetic resonance imaging and immunocytochemical studies. Stereotactic biopsies of areas showing hyperintense signal abnormalities on T2-weighted images in and adjacent to the involved visual pathways provided rarely obtained histological correlation of such areas. The patient received chemotherapy, which resulted in reduction of size and signal intensity of the tumor and stabilization of vision and growth velocity.

[Developing a questionnaire to evaluate pain in ocular or periocular pathologies: the ODEON questionnaire]. / Création d'un questionnaire destiné à la prise en charge de la douleur dans les pathologies oculaires et/ou péri-oculaires: ODEON - Objectif Douleur En Ophtalmologie et Neuro-ophtalmologie.

INTRODUCTION: Ophthalmologists contend with a wide range of painful acute and chronic diseases. However, there is no tool specific to ocular pain that aids the patient in describing and quantifying pain. PURPOSE: Our objective was to develop a tool that would allow the ophthalmologist to identify the patient's pain quickly and precisely in order to measure its intensity and to determine possible causes. METHODS: An interview guide was elaborated after a literature review. Structured interviews were conducted in hospitals by a clinical research associate with patients suffering from painful acute or chronic pathologies. Different types of quantification and description of pain were proposed to patients. A questionnaire was developed and tested. After the analysis of the tests, the ODEON pilot questionnaire (Objectif Douleur En Ophtalmologie et Neuro-ophtalmologie: target: ophthalmic and neuro-ophthalmic pain) was developed. RESULTS: Twenty patients presenting ten different diagnoses were interviewed. Patients preferred to quantify pain with visual analogic or graduated scales. They appreciated the help of pictograms to describe their pain. Eight other patients presenting six different diagnoses tested the questionnaire. They judged the test version valid and easy to use, except for the section on emotional descriptors. An average of approximately 20 minutes was necessary to complete the questionnaire. After the tests, various questions were combined, reformulated, deleted or added. The ODEON pilot questionnaire contains five sections: 1. general health, 2. eyes and eyesight, 3. pain, 4. pain relief, 5. pictograms and sensorial descriptors. The closed- and open-ended questions included in these dimensions make it possible to measure patient pain and help the practitioner with patient management. CONCLUSION: The ODEON pilot questionnaire was developed under the supervision of a pilot committee involving clinicians and methodologists. Patients have indicated acceptance of this self-administered questionnaire during the cognitive debriefing and it is now being validated.

[Relevance of quality of life and treatment compliance measurement in patients with chronic open-angle glaucoma]. / Intérêt de la mesurede la qualité de vie (QDV) et de l'observance thérapeutiquechez les patients atteints de glaucome chronique à angleouvert. Groupe d'étude Glaucome et Qualité de Vie.

Chronic glaucoma is a severe disease that can induce blindness.Early diagnosis and symptomatic treatment reduce the risk of blindness. Treatment that will be started before the onset of clinical signs and will remain lifelong thereafter is troublesome, and therapeutic compliance is usually poor. Thus, quality of life (QOL) measurement in patients with chronic glaucoma has a particular purpose: to measure patients' perception of the disease and treatment in order to maintain good treatment compliance to ensure therapeutic management efficacy and to preserve visual function. No glaucoma-specific instrument is available in the medical and QOL literature. Various generic(SF-36, SF-20 and SIP) and specific(VAQ, VF-14, NEI-VFQ) QOL questionnaires,one glaucoma-specific symptomatic scale (GSS),and one treatment preference scale (COMTol) have been used to measure QOL in glaucoma patients. These instruments do not sufficiently measure the psychosocial dimension of the disease and the QOL impact of treatment. An instrument able to measure all dimensions needs to be developed in order to help ophthalmologists in the therapeutic management of their patients and to measure QOLin patients in the successive stages of the disease.

[Creating a specific diagnostic and quality-of-life questionnaire for patients with ocular surface disease]. / Création d'un questionnaire spécifique d'aide au diagnostic et d'évaluation de la qualité de vie chez les patients souffrant de pathologie de la surface oculaire.

INTRODUCTION: Ocular surface diseases (OSD) affect about 15% of the population over 65 years of age. Nevertheless, OSD knowledge in the scientific community remains poor, and the healthcare system does not adequately recognize this disorder. However, many patients with OSD suffering from chronic pain experience substantial alteration in their quality of life (QoL). PURPOSE: Our work aimed at developing a patient self-evaluation questionnaire specific to OSD. This questionnaire could thus become a useful diagnostic tool that ophthalmologists could employ in daily practice in order to better understand patients'complaints and thereby correctly treat their disease. It also may serve as an evaluation tool in medical research. This article describes the phases of item generation, validation by experts, and identification of dimensions in the QoL section. METHODS: The questionnaire was developed in French by a group of experts including clinicians and methodologists. It comprised two parts: one on diagnostic aid, and the other on subjective perception of the disease (symptoms, perception of treatment, quality of life). The questionnaire was tested on five patients. It was then modified according to the patients' suggestions and tested again on 20 patients. After a second review by the scientific committee, a pilot questionnaire suitable for systematic use in quantitative studies was prepared. A cross-sectional observational study then identified the statistical dimensions of the QoL section, which led to a reduction in the total number of items. RESULTS: The resulting operational version of the questionnaire included four sections CONCLUSION: The next study will test the reproducibility of the operational version of the OSD questionnaire obtained after the item reduction phase.

[Creating a specific quality-of-life questionnaire in patients with glaucoma: item generation]. / Création d'un questionnaire spécifique évaluant la qualité de vie chez les patients glaucomateux: la génération des items.

The methods for developing Health-Related Quality-of-Life (HRQoL) measures and their application in medical research have demonstrated their utility in various chronic, progressive, or life-threatening diseases. The efforts made to allow the patient's perspective to be included in the methodological framework of evidence-based medicine have been successful. The assumption of a strong relationship between clinical status and daily life is certainly valid in ophthalmology. However, there is a lack of specific HRQoL measures dedicated to ophthalmic diseases. Our work aimed at creating the first Glaucoma-specific Quality of Life scale - the Glau-QoL questionnaire - to provide researchers and physicians with a comprehensive, practical, and validated tool. This article describes the first stage of the process, which consisted in generating items and formatting them in order to create a questionnaire that exhaustively covers the relevant concepts. The whole process was conducted by an expert committee including clinicians and methodologists. The standard recommendations in the development of a HRQoL questionnaire were followed: we first identified existing tools and performed a preliminary collection of concepts from the published literature; we then designed an interview guide with the help of clinicians; a trained psychologist interviewed 22 patients at various disease severity stages (from isolated hypertonic to severely impaired); the interviews were tape-recorded and scripted; general domains and related detailed concepts were identified from the script; they were then analyzed and organized; the format of the questionnaire was set up; and questions were derived from the patient's verbatim to capture the identified detailed concepts. The test questionnaire was applied to seven patients for cognitive debriefing. We finally amended the test questionnaire and designed the pilot questionnaire according to the patients' tests and the clinician's review. The test questionnaire was well accepted by the patients, despite a completion duration ranging from 14 to 35 minutes. The pilot questionnaire contained 151 items, grouped into 5 sections: (1) vision problems, physicians, and daily treatment (49 items); (2) activities of daily living (37 items); (3) self-expression (37 items); (4) vision problems and mood (14 items); and (5) other questions (14 items). The next step of our work will be the item reduction process and the psychometric validation of the Glau-QoL questionnaire.