Impaired Health Status and the Effect of Pain and Fatigue on Functioning in Clinical Trial Patients with Systemic Lupus Erythematosus
Why is this work in the frame?
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
No Canadian affiliation. An affiliation-only frame — the usual design — would never have seen this work. It is one of the works that make the case for inverting the frame.
The three-model screen
all 1,000 screened works →All three models called this out of scope.
Analysis of health status, pain and fatigue among lupus clinical trial patients; uses trial data to answer a clinical question.
The study examines health outcomes and treatment responses in patients with systemic lupus erythematosus.
Clinical analysis of pain/fatigue PROs in SLE trial patients; domain outcomes, not study of research methods.
Abstract
OBJECTIVE: Our study evaluated the impaired health status of clinical trial patients with systemic lupus erythematosus (SLE) and explored the relationship between changes in fatigue and pain and their effect on overall health status. METHODS: Pooled treatment and placebo data from a phase Ib clinical trial of adults with moderate/severe SLE were analyzed. Measures included patient-reported Medical Outcome Study Short Form-36 Survey, Version 2 (SF-36v2), Fatigue Severity Scale, and numeric rating scales (NRS) for pain and global health assessment and clinician-reported global assessment of disease activity (MDGA). Disease burden was compared to the US general population. Health status of responders and nonresponders on pain or fatigue were compared. RESULTS: The sample included 161 patients with SLE, predominantly female (96%) and white (72%), with average age of 43 ± 11 years. Mean SF-36v2 component summary scores reflected overall problems with physical [physical component summary (PCS); 35.2 ± 9.7] and mental health (mental component summary; 40.9 ± 12.9). Patients with SLE had worse health status on all SF-36v2 subscales than the US general population and comparable age and sex norms (effect size -0.51 to -2.15). Pain and fatigue responders had greater improvements on SF-36v2 scores (bodily pain, physical functioning, social functioning, PCS), patient global health assessment NRS, and MDGA than nonresponders. There was moderate agreement in responder status, based on global assessments by patients and clinicians (68.1%), with some discrepancy between patients who were MDGA responders but patient assessment nonresponders (27.7%). CONCLUSION: Improvements in patient-reported pain or fatigue correlated with improvements in overall health. Patient assessments offer a unique perspective on treatment outcomes. Patient-reported outcomes add value in understanding clinical trial treatment benefits.
Stored with the screening record, where it is evidence for the labels above.
The record
- Venue
- The Journal of Rheumatology
- Topic
- Systemic Lupus Erythematosus Research
- Field
- Medicine
- Canadian institutions
- —
- Funders
- —
- Keywords
- MedicineQuality of life (healthcare)Physical therapySF-36PopulationPlaceboClinical trialInternal medicineMental healthRating scaleGlobal Assessment of FunctioningDiseaseHealth related quality of lifePsychiatryAlternative medicine
- Has abstract in OpenAlex
- yes