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.

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.

Severe impairment of health-related quality of life in patients suffering from ocular surface diseases.

AIMS: To evaluate health-related quality of life (HRQoL) in French patients suffering from ocular surface diseases (OSDs). BACKGROUND: Specific instruments exist in the OSD area, but they do not comprehensively cover all domains of HRQoL. Recently, the OSD-specific questionnaire (OSD-QoL) was developed to address this need. METHODS: The OSD-QoL includes 28 items divided into seven dimensions: "Daily activities," "Difficulties with work and handicap," "Giving up make-up," "Acknowledgement of the disease," "Acceptance of the disease," "Fear for the future" and "Emotional well-being." The OSD-QoL was administered and completed by 214 French patients with OSDs. RESULTS: The mean scores of all OSD-QoL dimensions showed impairment, particularly "Acknowledgement of the disease," "Giving up make-up" and "Fear for the future"; 88.4% of patients thought that their eye problems were not acknowledged by people, 55.7% gave up make-up, and 53.9% feared they were incurable. Dimension scores differed according to patient characteristics; particularly, the more severe the ocular disease, the lower the scores of most of the OSD-QoL dimensions. Physical and psychological disability levels also had an impact on the dimension scores. CONCLUSION: OSDs have a detrimental impact on patients' HRQoL, that the specific OSD-QoL questionnaire was able to characterize. The level of impairment varies according to the severity of the disease and physical and psychological disability. The clinician's perception of their disease does not completely reflect the patient's perception of their disease.

[The "Compli'Asthme" therapeutic observation survey on good use of inhaled drugs for asthma: perception by general practitioners]. / Enquête "Compli'Asthme": observance thérapeutique et bonne utilisation des médicaments inhalés dans l'asthme perçues par les médecins praticiens.

A cross sectional survey was conducted in 2000 in coordination with the CHIESI medical representatives among 1758 French physicians caring for patients with persistent asthma (80% general practitioners, 20% specialists). This "Compli'Asthme" survey was based on a self-administered questionnaire designed to learn more about the physicians' experience with good use of inhaled drugs and to collect information on therapeutic observance, corticophobia, and use of prescribed inhalers. Poor observance was noted as an important problem by 58-85% of the participants. Most of the problems were related to inability to use the inhaler properly (children, elderly subjects) or to patients forgetting to take their medications (adults, parents). For 58% of the participating physicians, corticophobia is frequent. The patients are worried about the anabolizing effect, secondary effects, and dependence. When there is a potential problem with corticophobia, physicians generally question the patients and provide explanations to achieve good observance. Patient preference is taken into consideration by 86% of the physicians prescribing inhalation devices; 90% demonstrate use of the device at the first prescription and 68% make repeated demonstrations at subsequent consultations. For 56-87% of the physicians, poor therapeutic observance, corticophobia, and poor use of the inhaler can be detected and corrected. Patient education is an important element for 77% of the physicians for improving observance and achieving good use of the inhaler. When poor observance and poor use of the inhaler occur, the physicians responding to this questionnaire applied the currently recommended guidelines.

[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.

[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.