Study Short Form-36 Scales Research Articles

Measuring the impact of onychomycosis on patient quality of life.

According to survey research, onychomycosis, a fungal infection of the toenail or fingernail, affects quality of life including physical and social functioning and emotional health. We developed an onychomycosis disease-specific questionnaire (ODSQ) that sensitively assessed symptom distress, functional impact, and social stigma associated with the disease. Samples of patients enrolled in a randomized controlled clinical trial were used for the psychometric evaluations. The multi-item scales were internally consistent (alpha > or = 0.80) and reproducible (ICC > 0.85). Interscale correlations between the ODSQ and generic scales were moderate and consistent with the hypothesized magnitude and directions. Construct validation, employing known groups analysis, supported the hypothesized impact of onychomycosis on three domains of quality of life: physical functioning, emotional health, and social functioning. Significant differences were found between clinically "cured", "improved", or "failed" patients, and between mycologically "eradicated" and "persistent" patients. The ODSQ was responsive to clinical change and more sensitive than derived Medical Outcomes Study Short Form-36 scales. The ODSQ provides reliable, validated and responsive information about the consequences of onychomycosis and its treatment.

The Impact of Gastroesophageal Reflux Disease on Health-related Quality of Life

BACKGROUND: Gastroesophageal reflux disease (GERD) affects health-related quality of life. METHODS: We enrolled 533 adults with a history of heartburn symptoms for at least 6 months of moderate to severe heartburn in 4 of the 7 days before study entry. Patients were treated with ranitidine 150 mg twice a day for 6 weeks and Gelusil antacid tablets as needed. We measured physician-rated symptoms and the Medical Outcomes Study short-form 36 (SF-36) Health Survey at baseline and after 6 weeks of treatment. Baseline results were compared with normative data for the US population and for patients with selected chronic diseases. Treatment response was defined as no episode of moderate to severe heartburn for 7 days. Statistical significance was set at P <0.001. RESULTS: GERD patients reported significantly worse scores on all 8 SF-36 scales, physical function and well-being, and emotional well-being compared with the general population. Patients with GERD reported worse emotional well-being than patients with diabetes or hypertension. Treatment responders demonstrated significantly less pain and better physical function, social function, vitality, and emotional well-being compared with nonresponders. CONCLUSIONS: Patients with GERD experience decrements in health-related quality of life compared with the general population. The impact of GERD is most striking on measures of pain, mental health, and social function. Successful treatment for GERD results in improvements in health-related quality of life.

Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease.

The objective of this study was to evaluate the reliability and validity of the gastrointestinal Symptom Rating Scale (GSRS) in US patients with gastroesophageal reflux disease (GERD). Five hundred and sixteen adults with predominant heartburn symptoms of GERD were recruited from gastroenterologist and family physician practices and treated with 6 weeks of 150 mg ranitidine twice daily to identify poorly responsive symptomatic GERD. The GSRS, the Medical Outcomes Study Short Form-36 (SF-36) Health Survey and the Psychological General Well-being (PGWB) scale were administered at baseline and after 6 weeks of treatment. Reported ratings of GERD-related symptoms from physician and patient diaries were measured. The GSRS contains five scales: reflux syndrome, abdominal pain, constipation syndrome, diarrhoea syndrome and indigestion syndrome. The internal consistency reliabilities for the GSRS scales ranged from 0.61 to 0.83 and the intraclass correlation coefficients ranged from 0.42 to 0.60. The GSRS scale scores were correlated with the SF-36 and PGWB scales and with the number and severity of heartburn symptoms. Patients with two or three clinician-rated GERD-related symptoms reported worse GSRS scale scores compared with patients with fewer symptoms (p < 0.0001). Statistically significant differences in the mean GSRS scale scores were observed between treatment responders and non-responders (p < 0.0001) and patients showing a response to treatment had larger mean changes in their GSRS scales than patients not showing a response to treatment (p < 0.0001). The standardized response means ranged from 0.42 to 1.43 for the GSRS scale scores. It was concluded that the GSRS is a brief, fairly comprehensive assessment of common gastrointestinal symptoms. The GSRS has good reliability and construct validity and the GSRS scales discriminate by GERD symptom severity and are responsive to treatment. The GSRS is a useful patient-rated symptom scale for evaluating the outcomes of treatment for GERD.