Using PROGRESS-Plus to identify current approaches to the collection and reporting of equity-relevant data: a scoping review

Objectives: Our objectives were to identify what and how data relating to the social determinants of health are collected and reported in equity-relevant studies and map these data to the PROGRESS-Plus framework. Study Design and Setting: We performed a scoping review. We ran two systematic searches of MEDLINE and Embase for equityrelevant studies published during 2021. We included studies in any language without limitations to participant characteristics. Included studies were required to have collected and reported at least two participant variables relevant to evaluating individual-level social determinants of health. We applied the PROGRESS-Plus framework to identify and organize these data. Results: We extracted data from 200 equity-relevant studies, providing 962 items defined by PROGRESS-Plus. A median of 4 (interquartile range 5 2) PROGRESS-Plus items were reported in the included studies. 92% of studies reported age; 78% reported sex/gender; 65% reported educational attainment; 49% reported socioeconomic status; 45% reported race; 44% reported social capital; 33% reported occupation; 14% reported place and 9% reported religion. Conclusion: Our synthesis demonstrated that researchers currently collect a limited range of equity-relevant data, but usefully provides a range of examples spanning PROGRESS-Plus to inform the development of improved, standardized practices.Emma L. Karrana, Aidan G. Cashina, Trevor Barker, Mark A. Boyd, Alessandro Chiarotto, Omar Dewidar, Vina Mohabir, Jennifer Petkovic Saurab Sharma, Sinan Tejani, Peter Tugwell, G. Lorimer Mosele

Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease

BACKGROUND: Interstitial lung disease (ILD) is a common manifestation of systemic sclerosis and a leading cause of systemic sclerosis-related death. Nintedanib, a tyrosine kinase inhibitor, has been shown to have antifibrotic and antiinflammatory effects in preclinical models of systemic sclerosis and ILD. METHODS: We conducted a randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of nintedanib in patients with ILD associated with systemic sclerosis. Patients who had systemic sclerosis with an onset of the first non-Raynaud's symptom within the past 7 years and a high-resolution computed tomographic scan that showed fibrosis affecting at least 10% of the lungs were randomly assigned, in a 1:1 ratio, to receive 150 mg of nintedanib, administered orally twice daily, or placebo. The primary end point was the annual rate of decline in forced vital capacity (FVC), assessed over a 52-week period. Key secondary end points were absolute changes from baseline in the modified Rodnan skin score and in the total score on the St. George's Respiratory Questionnaire (SGRQ) at week 52. RESULTS: A total of 576 patients received at least one dose of nintedanib or placebo; 51.9% had diffuse cutaneous systemic sclerosis, and 48.4% were receiving mycophenolate at baseline. In the primary end-point analysis, the adjusted annual rate of change in FVC was 1252.4 ml per year in the nintedanib group and 1293.3 ml per year in the placebo group (difference, 41.0 ml per year; 95% confidence interval [CI], 2.9 to 79.0; P=0.04). Sensitivity analyses based on multiple imputation for missing data yielded P values for the primary end point ranging from 0.06 to 0.10. The change from baseline in the modified Rodnan skin score and the total score on the SGRQ at week 52 did not differ significantly between the trial groups, with differences of 120.21 (95% CI, 120.94 to 0.53; P=0.58) and 1.69 (95% CI, 120.73 to 4.12 [not adjusted for multiple comparisons]), respectively. Diarrhea, the most common adverse event, was reported in 75.7% of the patients in the nintedanib group and in 31.6% of those in the placebo group. CONCLUSIONS: Among patients with ILD associated with systemic sclerosis, the annual rate of decline in FVC was lower with nintedanib than with placebo; no clinical benefit of nintedanib was observed for other manifestations of systemic sclerosis. The adverse-event profile of nintedanib observed in this trial was similar to that observed in patients with idiopathic pulmonary fibrosis; gastrointestinal adverse events, including diarrhea, were more common with nintedanib than with placebo