Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards

Objective. SSc is clinically and aetiopathogenically heterogeneous. Consensus standards for more uniform trial design and selection of outcome measures are needed. The objective of this study was to develop evidence-based points to consider (PTCs) for future clinical trials in SSc. Methods. Thirteen international SSc experts experienced in SSc clinical trial design were invited to participate. One researcher with experience in systematic literature review and three trainees were also included. A systematic review using PubMed and the Cochrane Central Register of Controlled Trials was conducted and PTCs when designing clinical trials in SSc were developed. As part of that development we conducted an Internet-based Delphi exercise regarding the main points to be made in the consensus statement. Consensus was defined as achieving a median score of ≥7 of 9. Results. By consensus, the experts decided to develop PTCs for each individual organ system. The current document provides a unifying outline on PTCs regarding general trial design, inclusion/exclusion criteria and analysis. Consensus was achieved regarding all the main points of the PTCs. Conclusion. Using European League Against Rheumatism suggestions for PTCs, a general outline for PTCs for controlled clinical trials in SSc was developed. Specific outlines for individual organ systems are to be published separately. This general outline should lead to more uniform and higher-quality trials and clearly delineate areas where further research is neede

Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards

OBJECTIVE SSc is clinically and aetiopathogenically heterogeneous. Consensus standards for more uniform trial design and selection of outcome measures are needed. The objective of this study was to develop evidence-based points to consider (PTCs) for future clinical trials in SSc. METHODS Thirteen international SSc experts experienced in SSc clinical trial design were invited to participate. One researcher with experience in systematic literature review and three trainees were also included. A systematic review using PubMed and the Cochrane Central Register of Controlled Trials was conducted and PTCs when designing clinical trials in SSc were developed. As part of that development we conducted an Internet-based Delphi exercise regarding the main points to be made in the consensus statement. Consensus was defined as achieving a median score of ≥7 of 9. RESULTS By consensus, the experts decided to develop PTCs for each individual organ system. The current document provides a unifying outline on PTCs regarding general trial design, inclusion/exclusion criteria and analysis. Consensus was achieved regarding all the main points of the PTCs. CONCLUSION Using European League Against Rheumatism suggestions for PTCs, a general outline for PTCs for controlled clinical trials in SSc was developed. Specific outlines for individual organ systems are to be published separately. This general outline should lead to more uniform and higher-quality trials and clearly delineate areas where further research is needed

First Ground-Based Infrared Solar Absorption Measurements of Free Tropospheric Methanol (CH3OH): Multidecade Infrared Time Series from Kitt Peak (31.9 deg N 111.6 deg W): Trend, Seasonal Cycle, and Comparison with Previous Measurements

Atmospheric CH3OH (methanol) free tropospheric (2.09-14-km altitude) time series spanning 22 years has been analyzed on the basis of high-spectral resolution infrared solar absorption spectra of the strong n8 band recorded from the U.S. National Solar Observatory on Kitt Peak (latitude 31.9degN, 111.6degW, 2.09-km altitude) with a 1-m Fourier transform spectrometer (FTS). The measurements span October 1981 to December 2003 and are the first long time series of CH3OH measurements obtained from the ground. The results were analyzed with SFIT2 version 3.93 and show a factor of three variations with season, a maximum at the beginning of July, a winter minimum, and no statistically significant long-term trend over the measurement time span

First ground-based infrared solar absorption measurements of free tropospheric methanol (CH3OH): Multidecade infrared time series from Kitt Peak (31.9°N 111.6°W), trend, seasonal cycle, and comparison with previous measurements

Atmospheric CH3OH (methanol) free tropospheric (2.09-14 km altitude) time series spanning 22 years has been analyzed based on high spectral resolution infrared solar absorption spectra of the strong ν8 band recorded from the U.S. National Solar Observatory on Kitt Peak (latitude 31.9°N, 111.6°W, 2.09 km altitude) with a 1-m Fourier transform spectrometer (FTS). The measurements span October 1981 to December 2003 and are the first long time series of CH3OH measurements obtained from the ground. The results were analyzed with SFIT2 version 3.93 and show a factor of three variations with season, a maximum at the beginning of July, a winter minimum, and no statistically significant long-term trend over the measurement time span

Variability-lifetime relationship for organic trace gases: A novel aid to compound identification and estimation of HO concentrations

In this study we report aircraft‐borne measurements of organic species made during March 1998 in Surinam, an unpolluted region on the northeast coast of South America Measurements included the following: CO by tunable diode laser; a wide variety of organics including acetone, acetonitrile, and isoprene by proton transfer mass spectrometry (PTR‐MS); and nonmethane hydrocarbon measurements by gas chromatography‐flame ionization detection. Here we compare the standard deviation of the natural logarithm of the mixing ratio (Sigma_lnX) to the estimated lifetime of these species. This relationship has been used to support identification of masses measured by the PTR‐MS; ascertain the consistency and quality of hydrocarbon measurement data; and to provide information concerning sinks of important trace species. A selection of the data is used to indirectly determine an average HO concentration of 2.0 × 105 molecules cm−3 along the back trajectory for air encountered during the Large‐Scale Biosphere‐Atmosphere Experiment in Amazonia‐Cooperative LBA Airborne Regional Experiment (LBA‐CLAIRE) measurement campaign between 0–1 km over the tropical rain forest. The lower than expected HO concentration derived could have been caused by significant atmospheric or oceanic photochemical production of acetone and MEK along the back trajectory