Content validity of a novel patient-reported and observer-reported outcomes assessment to evaluate ocular symptoms associated with infectious conjunctivitis in both adult and pediatric populations.

BACKGROUND: Acute infectious conjunctivitis is a common condition most frequently caused by viruses or bacteria. Clinical outcome assessments have been used to assess signs and symptoms of bacterial and viral conjunctivitis, but have not been evaluated for content validity. We aimed to develop content-valid patient- (PRO) and observer-reported outcome (ObsRO) instruments to assess symptoms of ocular discomfort associated with viral or bacterial conjunctivitis in adult and pediatric patients. METHODS: Draft items were developed from a previous review of published studies from 2001 to 2015. Patients and caregivers of patients with a diagnosis of viral or bacterial conjunctivitis within the past 6 months were recruited. Concept elicitation with open-ended questions explored signs and symptoms, followed by cognitive interviewing to assess clarity and relevance of the draft items. Patients aged ≥8 years were interviewed for the PRO; parents/caregivers of children aged 1-10 years were interviewed for the ObsRO. Interviews were conducted in three rounds to allow changes. Concept saturation was documented using a saturation grid. Cognitive interview data were analyzed iteratively and focused on clarity, relevance and inconsistent interpretation of the instrument's content. RESULTS: Overall, 23 patients or parents/caregivers participated (round 1, n = 10; round 2, n = 6; round 3, n = 7). Data saturation was reached by the 16th interview. The most frequent spontaneously reported signs/symptoms were: discharge, red/pink eyes, itchiness, swelling/puffiness, watery eyes, pain, burning and foreign body sensation. Itching, pain/burning/stinging and foreign body sensation were most commonly reported as the top three most bothersome symptoms. Interview results indicated that items on pain, itching and foreign body sensation for the PRO and pain or discomfort for the ObsRO were relevant to the patients' experience of conjunctivitis and were clear and easy to understand. CONCLUSIONS: PRO and ObsRO items were found to be clear, relevant and appropriate in assessing key viral and bacterial conjunctivitis symptoms in adult and pediatric patients.

Ocular Diseases Among Pathologists and Pathologists' Perceptions on Ocular Diseases: A Survey Study.

OBJECTIVE: The impact of visual disorders and color vision deficiency on the occupational life has been previously investigated by several studies. In this study, we aimed to evaluate the prevalence of visual disorders among Turkish pathologists and their perceptions on visual disorders. MATERIAL AND METHOD: A survey composed of 14 questions about ocular diseases and perceptions to these diseases has been introduced to the volunteering pathologists or pathology residents, participating in the 23rd Congress of Pathology. RESULTS: Ninety-three pathologists or pathology residents participated in the survey. Of the participants, 25 (26.9%) were residents, 30 (32.3%) were pathology specialists, and 36 (38.7%) were academicians. The mean duration for working as a pathologist was 15 years. The vast majority (%93.5) of the participants had at least one type of refractive error; the two most common disorders were myopia (77.0%) and astigmatism (64.4%). Sixty-four of the participants (68.8%) claimed an increase in their refractive error after working in the pathology department. Eyeglasses (56/87, 64.4%), contact lenses (14/87, 16.1%), or both (9/87, 10.3%) were used in order to correct the refractive error; however, only 31 of the participants (33.3%) preferred using eyeglasses during microscopy. While 65 participants (69.9%) never had conjunctivitis, 26 participants (28.0%) had at least one conjunctivitis attack. None of the participants claimed to be color blind. CONCLUSION: Conjunctivitis and refractive errors are quite prevalent among pathologists. Refractive errors were also found to increase during the pathology practice. Most of the pathologists do not consider visual disorders (mostly refractive errors) as a negative factor during their career decision making, except a color vision defect.

RHINASTHMA-Adolescents: a new quality of life tool for patients with respiratory allergy.

BACKGROUND: Specific instruments for health-related quality of life (HRQoL) assessment in adolescents with rhinoconjunctivitis or asthma are available. None of them evaluates rhinitis and asthma together, although they often coexist. Our aim was to validate a HRQoL questionnaire for adolescents with rhinoconjunctivitis, asthma, or both. METHODS: A pool of 38 items covering the main symptoms and problems related to respiratory allergy was generated based on literature review, clinical experience, and unstructured interviews to 54 adolescents. The items were randomly listed and presented to 88 consecutive outpatients (44 M; mean age 15.2 ± 3.1). Patients had to indicate which item they had experienced and, for each selected item, its importance on a four-point scale (1 = not at all; 4 = very much). Twelve items were excluded from the list, because of low importance. In the validation phase, 102 patients (54 M; mean age 15.36 ± 1.12) completed the KINDL, a generic HRQoL tool, and the new questionnaire (RHINASTHMA-Adolescents). RESULTS: Factor analysis revealed a five-dimensional structure, which explained up to 71.23% of the total variance. Association between RHINASTHMA-Adolescents and KINDL scores was all in the expected direction. Internal consistency for the extracted factors was satisfactory: Upper Airways (0.81), Lower Airways (0.89), Emotions (0.85), Social Relationship (0.79), Daily life management (0.74). Reliability was good for all factors with a Pearson coefficient ranged from 0.91 to 0.99. CONCLUSIONS: RHINASTHMA-Adolescents is the first tool for evaluating HRQoL in patients with rhinitis and/or asthma. It provides a simple assessment and met the standards of validity, internal consistency, and reliability.

[Perception of health risks due to air pollution among adolescents in Mexico City]. / Percepción de riesgo a la salud por contaminación del aire en adolescentes de la Ciudad de México.

OBJECTIVE: Analyze the relations established between air pollution and health-disease-death in a sample of students in Mexico City. MATERIAL AND METHODS: Survey of 1274 students from 14 secondary schools in five areas in Mexico City was conducted between March and April of 2003. We used a multi-stage sampling, based in a basic geostatistical areas (AGEB). RESULTS: A total of 84.4% believed that Mexico City has a high, or very high air pollution; that valuation decreases as it approaches the most immediate place in which the students live. The health risks range from effects on respiratory health, 66.9%, to other effects on daily life, 2.2%. The predictors that air pollution is perceived as serious/very serious are: 1) that they associate it with the possibility of causing death (OR= 1.35, 95% CI=1.02-1.77), and 2) that they attend schools located in the La Merced zone, (OR= 2.23, 95% CI= 1.56-3.21). CONCLUSIONS: Determinants of perception, such as gender, zone where the school is located and the differences in air quality perceived in the city/area/schools, suggest that focalizing components must be involved in environmental policies, in order to make environmental programs more effective at the local level.

Percepción de riesgo a la salud por contaminación del aire en adolescentes de la Ciudad de México / Perception of health risks due to air pollution in adolescents in Mexico City

OBJETIVO: Analizar las relaciones que se establecen entre contaminación del aire y salud-enfermedad-muerte en una muestra de estudiantes de la Ciudad de México. MATERIAL Y MÉTODOS: Se realizó una encuesta a 1 274 alumnos de secundaria de 14 escuelas en cinco zonas del Distrito Federal, entre marzo y abril de 2003. Muestreo polietápico de áreas geoestadísticas básicas (AGEB). RESULTADOS: El 84.4 por ciento considera alta o muy alta la contaminación del aire en la Ciudad de México, que disminuye al aproximarse al espacio más inmediato del alumno. Los riesgos a la salud van desde efectos en la salud respiratoria, 66.9 por ciento, a otras consecuencias en la vida diaria, 2.2 por ciento. Los predictores de percibir la contaminación como grave/muy grave son: a) que la asocien con la posibilidad de causar la muerte (RM= 1.35, IC 95 por ciento= 1.02-1.77), y b) asistencia a escuelas en la zona de La Merced (RM= 2.23, IC 95 por ciento= 1.56-3.21). CONCLUSIONES: Los determinantes de la percepción para esta población de adolescentes son: género, zona de ubicación de la escuela y las diferencias en la calidad del aire percibidas en la ciudad/colonia/plantel educativo. Lo anterior permite sugerir que en la política ambiental debe incorporarse el componente de la focalización, de tal manera que los programas ambientales sean más eficientes en el ámbito local.

OBJECTIVE: Analyze the relations established between air pollution and health-disease-death in a sample of students in Mexico City. MATERIAL AND METHODS: Survey of 1274 students from 14 secondary schools in five areas in Mexico City was conducted between March and April of 2003. We used a multi-stage sampling, based in a basic geostatistical areas (AGEB). RESULTS: A total of 84.4 percent believed that Mexico City has a high, or very high air pollution; that valuation decreases as it approaches the most immediate place in which the students live. The health risks range from effects on respiratory health, 66.9 percent, to other effects on daily life, 2.2 percent. The predictors that air pollution is perceived as serious/very serious are: 1) that they associate it with the possibility of causing death (OR= 1.35, 95 percent CI=1.02-1.77), and 2) that they attend schools located in the La Merced zone, (OR= 2.23, 95 percent CI= 1.56-3.21). CONCLUSIONS: Determinants of perception, such as gender, zone where the school is located and the differences in air quality perceived in the city/area/schools, suggest that focalizing components must be involved in environmental policies, in order to make environmental programs more effective at the local level.

Development and validation of an electronic version of the Rhinoconjunctivitis Quality of Life Questionnaire.

BACKGROUND: As clinicians and pharmaceutical companies move from paper versions of health status questionnaires to electronic versions, it cannot be assumed that adaptations to other media will produce valid data. AIMS: The aims of this study were to (1) adapt the Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S); standardized version], for the Palm Treo 650, (2) test the device for ease and accuracy of understanding and (3) examine the validity of the electronic version by comparing it with the original paper version of the RQLQ(S). METHODS: Seventy adults with current rhinoconjunctivitis symptoms completed the electronic and paper versions of the RQLQ(S). They were randomized to complete either the paper or the electronic version first. After a 2-h break, they completed the other version. RESULTS: Concordance between paper and electronic versions for the overall RQLQ(S) score was acceptable with an intraclass correlation coefficient of 0.95 and there was no evidence of bias (P = 0.13). Concordance for the seven individual domains ranged from 0.86 to 0.94. A small but significant bias was observed in the activity and sleep domains (P = 0.02). Completion times were quicker with paper (4.1 vs 4.9 min, P < 0.0001). About 51% of patients preferred electronic, 17% preferred paper and 31% had no preference. CONCLUSIONS: This electronic version of the RQLQ(S) was easy for patients to use and the concordance between paper and this version on the Palm Treo 650 provides evidence of the validity of this electronic version.

[Validation of the Spanish version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)]. / Validación de la versión española del cuestionario de calidad de vida para pacientes con rinoconjuntivitis.

OBJECTIVE: Validate the questionnaire Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in conditions of regular clinical practice. METHODS: Two hundred and eighty four adult patients with a diagnosis of rhinoconjunctivitis (RC) cared in 37 centers of specialized health care in allergy or otorhinolaryngology services in Spain were analyzed. Patients with RC were included in two groups: clinically non-stable patients who received treatment with an oral second generation antihistaminic (group A), and clinically stable patients (group B). Sociodemographic and clinical variables were collected and the questionnaires RQLQ and EQ-5D were administered in the initial visit and in the second visit 15 days after. Feasibility, validity, reliability and sensitivity related to the change of the RQLQ were analyzed. RESULTS: The mean period (standard deviation) of administration was 9.67 (6.25) minutes and 85.6% of patients needed assistance in order to fill the RQLQ, especially the selection of the characteristics (62.5%). The dimensions of the RQLQ showed a greater association with the dimensions of the EQ-5D that assessed similar aspects and the symptoms in which a greater relation was expected. The alpha Cronbach coefficient of the scorings of the RQLQ fluctuated between 0.85 and 0.96 and the intraclass correlation coefficient fluctuated between 0.68 and 0.89. The sensitivity to the change of the dimensions of the RQLQ, evaluated through the magnitude of the effect between the two visits, ranged between 0.76 and 1.46. CONCLUSIONS: The Spanish version of the RQLQ proved to be a valid instrument for assessing the Health-Related Quality of Life (HRQL) in adult patients with seasonal or perennial RC.

Self-inflicted (factitious) conjunctivitis.

PURPOSE: To describe the diagnosis and management of self-inflicted factitious conjunctivitis in conscripted soldiers. DESIGN: Prospective, noncomparative, consecutive case series. PARTICIPANTS: Seventeen conscripted soldiers. METHODS: Soldiers with chronic conjunctivitis (>3 weeks) were referred by ophthalmologists, and cases of shorter duration were referred by primary-care physicians. All cases underwent thorough ophthalmic and systemic history and examination, as well as questioning regarding their military units, military duties, and social background. Exclusion criteria were any condition that may cause conjunctivitis. Inferior fornix specimen microscopy and culture and eye photography were performed in most cases. In cases suspected of self-inflicted conjunctivitis all medication, besides lubricant drops, was stopped. Underlying psychosocial problems were investigated and managed. Cases were followed for at least 3 months after resolution of the conjunctivitis, at which point the diagnosis was confirmed, and the case entered the analysis. MAIN OUTCOME MEASURES: Resolution of the conjunctivitis. RESULTS: Seventeen consecutive cases of self-inflicted conjunctivitis, 8 of long duration and 9 of short duration, were studied. All cases demonstrated inconsistent clinical findings. The ocular signs most suggestive of self-inflicted conjunctivitis were purulent discharge purposely left on the lashes and periorbital skin, discharge more severe than in conjunctival hyperemia, less conjunctival chemosis than in hyperemia, mainly inferior conjunctival involvement, and an uninvolved cornea. Five of the 8 chronic cases had significant underlying psychologic or social problems. Their conjunctivitis resolved only after their underlying problems were addressed. Two cases admitted introducing freshly scraped dental plaque into the lower conjunctival sac. In the remaining 15 the similarity of the clinical findings suggested that a similar method was used. CONCLUSIONS: In the context of a subject standing to gain by assuming the sick role and after exclusion of ocular pathology, self-inflicted conjunctivitis can be reliably diagnosed by noting the characteristic clinical profile. Effective management includes addressing the underlying psychologic and social problems.

Can the standard gamble and rating scale be used to measure quality of life in rhinoconjunctivitis? Comparison with the RQLQ and SF-36.

BACKGROUND: With interest in health economics growing, it is important to know whether utilities may be used to measure health-related quality of life in patients with rhinoconjunctivitis. The objective was to compare the validity and measurement properties of disease-specific versions of the standard gamble and rating scale with those of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and the Short-Form 36 (SF-36). METHODS: One hundred adults with symptomatic rhinoconjunctivitis participated in a 5 week observational study, completing the standard gamble, rating scale, RQLQ and SF-36 at baseline and after 1 and 5 weeks. Symptom diaries were completed for 1 week before each follow-up visit. RESULTS: Reliability was highest for the RQLQ (intraclass correlation coefficient = 0.97), followed by the rating scale (0.75), the SF-36 physical (0.75), the SF-36 mental (0.74) and the standard gamble (0.12). The responsiveness index was highest for the RQLQ (0.76), followed by the rating scale (0.56) and the SF-36 mental (0.28). Both cross-sectional and longitudinal validity were strongest for the RQLQ and the rating scale. CONCLUSIONS: Both the rating scale and the RQLQ have strong evaluative and discriminative properties. The SF-36 has acceptable discriminative properties but its evaluative properties are poor. All measurement properties for the standard gamble are inadequate. Poor correlation between the standard gamble and the rating scale indicates that utilities cannot be derived from rating scale data.

Development and validation of the mini Rhinoconjunctivitis Quality of Life Questionnaire.

BACKGROUND: The 28-item Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) has strong measurement properties but for large clinical trials, surveys and practice monitoring, where high efficiency is important, a shorter questionnaire is needed. OBJECTIVE: To develop and validate an abbreviated version of the RQLQ. METHODS: Using five RQLQ databases, items with high item-item correlations were combined and then the highest scoring items were selected for the MiniRQLQ (14 questions). There are five domains: activity limitations (standardized), practical problems and nose symptoms, eye symptoms and other symptoms. The MiniRQLQ, which is self-administered, was tested in a 5-week observational study in 100 adults with symptomatic rhinoconjunctivitis. Patients completed the MiniRQLQ, the RQLQ, and other measures of health status at baseline, 1 and 5 weeks. RESULTS: In patients whose rhinoconjunctivitis was stable between clinic visits, reliability (reproducibility and ability to discriminate between patients of different impairment) was very acceptable for the MiniRQLQ (ICC = 0.93) but not quite as good as for the RQLQ (ICC = 0.97). Responsiveness to change in clinical status was better with the MiniRQLQ than the RQLQ (P = 0. 044). Construct validity (correlation with other indices of health status) was strong for both the MiniRQLQ and the RQLQ. Concordance between the two instruments was high (ICC = 0.87). CONCLUSIONS: The MiniRQLQ has strong measurement properties and measures the same construct as the original RQLQ. The choice of questionnaire should depend on the task at hand.

Validation of the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire.

BACKGROUND: In the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), the 3 activity questions are selected by the patients themselves. For greater efficiency, a version with standardized activities is required. OBJECTIVE: Our purpose was to develop and validate a standardized version of the RQLQ, the RQLQ(S). METHODS: With use of 5 RQLQ databases, we identified the activities most frequently selected by patients and formulated 3 generic questions that would encompass the majority of these activities. The RQLQ(S) was tested in a 5-week observational study in 100 adults with symptomatic rhinoconjunctivitis. Patients completed the RQLQ(S), the RQLQ, and other measures of health status at baseline and 1 and 5 weeks. RESULTS: The activity domain of the RQLQ(S) consistently gave lower scores than did the activity domain of the RQLQ (P <.001). However, this made very little difference to the overall scores (RQLQ[S] = 2.36 +/- 1.23, RQLQ = 2.43 +/- 1.23), and overall concordance was high (intraclass correlation coefficient = 0.996). In patients whose rhinoconjunctivitis was stable between clinic visits, reliability (reproducibility and ability to discriminate between patients of different impairment) was high for both instruments and almost identical (intraclass correlation coefficient = 0.97). Responsiveness to change was also very similar and good (P <.001). Construct validity (correlation with other index values of health status) was strong for both the RQLQ(S) and the RQLQ. CONCLUSIONS: The RQLQ(S) has strong measurement properties and measures the same construct as the original RQLQ. The choice of questionnaire should depend on the task at hand.

Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis.

The objective of this study was to develop and test a health-related quality of life questionnaire for clinical trials in rhinoconjunctivitis. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was developed by asking patients to identify areas of their lives affected by rhinoconjunctivitis. The resultant RQLQ was tested for reproducibility, responsiveness and validity in a randomized, double-blind trial of regular versus 'as required' aqueous beclomethasone dipropionate (BDP) nasal spray in ragweed pollen-induced rhinoconjunctivitis. Eighty-five patients from previous rhinoconjunctivitis studies participated in the developmental survey. Sixty ragweed-sensitive patients, from previous trials and media notices, were enrolled in the clinical trial. Aqueous BDP (800 micrograms) nasal spray was administered regularly or 'as required' throughout the ragweed pollen season. The survey revealed that, in addition to local symptoms of rhinoconjunctivitis, patients experienced impairment of quality of life through systemic symptoms, sleep disturbance, practical problems, activity limitations and emotional problems. The RQLQ includes 28 questions related to these dimensions. Repeated administration of the RQLQ demonstrated good reproducibility. During the clinical trial, the RQLQ proved responsive in its ability to distinguish between regular and 'as required' medication use. Validity was shown by moderate to strong relations between changes in symptom diary scores and changes in RQLQ scores. In conclusion the RQLQ is likely to prove useful as a measure of health-related quality of life in clinical trials in both rhinoconjunctivitis and rhinitis.