RESUMEN
BACKGROUND: Evaluation of acute rhinosinusitis treatment effectiveness is based on patient-reported relief of symptoms. This study was designed to develop a multiattribute utility scoring algorithm for the Major Symptom Score (MSS) and secondarily to evaluate the psychometric characteristics (i.e., validity and responsiveness) of the MSS Utility Index (MSSUI). METHODS: Adult patients with acute rhinosinusitis were recruited for this longitudinal observational study through primary care and specialist physician offices. One hundred ninety patients participated in a preference elicitation exercise for MSS health states. Resulting preference data were used to generate a utility scoring algorithm for the MSS. Participants completed the MSS and 20-Question Sino-Nasal Outcome Test (SNOT-20) at baseline and completed the MSS twice daily for 15 days via daily diary. On days 7 and 15, participants completed the MSS, SNOT-20, and Overall Treatment Effect scale and were evaluated by physicians via the Physician Global Improvement Scale (PGIS). RESULTS: At baseline, the mean ± SD. MSSUI score was 0.51 ± 0.17 and was negatively correlated with SNOT-20 scores (r = -0.58; p < 0.001). Days 2-8 average MSSUI scores were negatively correlated with day 7 SNOT-20 (r = -0.46; p < 0.001) and PGIS (r = -0.22; p < 0.001) scores; whereas days 9-15 average MSSUI scores were inversely related to day 15 SNOT-20 (r = -0.40; p < 0.001) and PGIS (r = -0.32, p < 0.001) scores. Mean MSSUI scores improved from baseline with effect sizes at days 7 and 15 of 0.82 and 1.20, respectively. CONCLUSION: The MSSUI represents an acceptable and psychometrically sound patient-reported end point for clinical trials comparing treatments for acute rhinosinusitis.
Asunto(s)
Rinitis/diagnóstico , Rinitis/fisiopatología , Sinusitis/diagnóstico , Sinusitis/fisiopatología , Enfermedad Aguda , Adulto , Algoritmos , Progresión de la Enfermedad , Dolor Facial , Femenino , Estudios de Seguimiento , Cefalea , Humanos , Masculino , Persona de Mediana Edad , Obstrucción Nasal , Psicometría , Proyectos de Investigación/normas , Rinitis/patología , Rinitis/psicología , Índice de Severidad de la Enfermedad , Sinusitis/patología , Sinusitis/psicología , Encuestas y Cuestionarios/normasRESUMEN
PURPOSE: The aim of this study is to develop and validate a brief instrument for the measurement of overall psychosocial impact of frequent heartburn (heartburn experienced 2+ times weekly) in the general U.S. population, yielding a single, composite score. METHODS: Item reduction and psychometric analyses of an existing Frequent Heartburn (FHB) Survey, a 52-item, 13-domain, patient-reported outcomes (PRO) survey assessing the impact of frequent heartburn on psychosocial quality of life. RESULTS: Item reduction resulted in 9 items from the original FHB Survey measuring all domains. All retained items in this full Frequent Heartburn Index (FHBI-Full) had moderate to strong factor loadings on the underlying factor (range: 0.66-0.85) and acceptable overall model fit (CFI = 0.93, SRMR = 0.04). Coefficient alpha was 0.92. A shorter FHBI (FHBI-Brief) was created that excludes the two employment-related items. The FHBI-Brief had a coefficient alpha of 0.90. CONCLUSIONS: Both FHBI versions have good psychometric properties and capture a full range of psychosocial effects of frequent heartburn. Normed national scores for the FHBI are available against which an individual can compare their own FHBI score. The FHBI-Full and FHBI-Brief show promise as PRO instruments that may help individuals and clinicians better understand the effect of frequent heartburn on psychosocial functioning.
Asunto(s)
Pirosis/psicología , Encuestas y Cuestionarios/normas , Femenino , Pirosis/epidemiología , Pirosis/fisiopatología , Humanos , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Psicometría , Estados Unidos/epidemiologíaRESUMEN
INTRODUCTION: Although the Sexual Encounter Profile (SEP) and International Index of Erectile Function (IIEF) are frequently used to measure erectile dysfunction (ED) treatment outcomes, stopwatch-assessed duration of erection is a new, objective, and potentially useful endpoint of ED treatment effect. AIMS: To assess the validity and reliability of stopwatch-assessed erection duration against responses to SEP items 2 (SEP-2) and 3 (SEP-3) and IIEF scale scores. METHODS: Data were taken from a multi-center trial of vardenafil for the treatment of ED. Patients were randomized to vardenafil 10 mg or placebo for 4 weeks. After a 1-week washout period, patients received the alternate therapy for an additional 4 weeks. An electronic diary was used to record information about sexual attempts. The duration of erection was measured using a stopwatch and transcribed into the diary. The SEP was completed following each sexual attempt, and the IIEF was completed at the end of each treatment period. MAIN OUTCOME MEASURES: Mean and median values of erection duration, mean SEP-2 and SEP-3 success rates, and scores for each of the 5 IIEF scales were calculated. RESULTS: At baseline, correlations of median erection duration with the 5 IIEF scale scores ranged from 0.06 to 0.53, while correlations with mean SEP-2 and SEP-3 success rates were 0.66 and 0.49, respectively. Compared with the other measures, mean and median values of erection duration were less sensitive to differences between placebo- and vardenafil-treated patients and less responsive to clinical change associated with treatment crossover. However, mean erection duration exhibited a good level of reliability (intraclass correlation coefficient = 0.72, P < 0.001). CONCLUSIONS: This study provides evidence for the validity and reliability of stopwatch-assessed duration of erection. Our findings suggest that erection duration is suitable for use as a unique endpoint in ED treatment-efficacy trials conducted for phosphodiesterase type 5 inhibitors.
Asunto(s)
Disfunción Eréctil/diagnóstico , Disfunción Eréctil/tratamiento farmacológico , Imidazoles/farmacología , Imidazoles/uso terapéutico , Cooperación Internacional , Relaciones Interpersonales , Inhibidores de Fosfodiesterasa 5 , Inhibidores de Fosfodiesterasa/farmacología , Inhibidores de Fosfodiesterasa/uso terapéutico , Piperazinas/farmacología , Piperazinas/uso terapéutico , Conducta Sexual , Encuestas y Cuestionarios , Humanos , Masculino , Valores de Referencia , Índice de Severidad de la Enfermedad , Sulfonas/farmacología , Sulfonas/uso terapéutico , Factores de Tiempo , Resultado del Tratamiento , Triazinas/farmacología , Triazinas/uso terapéutico , Diclorhidrato de VardenafilRESUMEN
BACKGROUND: Nasal congestion associated with allergic rhinitis has been shown to be the most bothersome symptom. Ocular symptoms may be troublesome to patients as well. OBJECTIVE: To estimate the relative strength of relationships of nasal congestion and ocular symptoms associated with allergic rhinitis with patient-reported outcomes of sleep quality; practical problems; somnolence; impairment at work, class, activities; and mood. METHODS: Patients (n = 404) presenting with symptoms of allergic rhinitis completed five patient-reported outcomes that assessed the effect of morning allergic rhinitis symptoms on patients' reports of sleep, work and activity impairment, and mood. Multiple regression analyses were used to compare the relative strength of relationships of congestion and ocular symptoms with the patient-reported outcomes. RESULTS: The majority of patients had both nasal congestion and ocular symptoms at baseline. A single nasal congestion item and a 3-item ocular symptom score were significantly related to the patient-reported outcomes: those with more severe congestion or ocular symptoms reported more negative scores on the patient-reported outcomes. Nasal congestion had the stronger relationship with patient-reported outcomes total scores or subscales in 14 of 20 regressions. CONCLUSION: Although nasal congestion is generally more strongly related to the patient-reported outcomes, ocular symptoms have a significant negative effect on patients' lives. Study limitations include: (1) only baseline data were used because of greater severity and variability of symptoms scores; we are unable to establish causal relationships or discuss change, only correlation/covariation; (2) recruitment took place from September through November, thus different patients might have been recruited if sampling took place during the spring; (3) patients were screened for nasal congestion not for ocular symptoms, though there was high co-occurrence of each. These limitations aside, congestion and ocular symptoms are troublesome to patients and typically co-occur. Evaluating and treating these symptoms are key to managing allergic rhinitis and improving patient-reported outcomes.