Heterogeneity of Outcome Measures Used in Randomized Controlled Trials for the Treatment of Oral Lichen Planus: A Methodological Study

Abstract

This work reports on the application of a novel electric field-ionization setup for high-resolution laser spectroscopy measurements on bunched fast atomic beams in a collinear geometry. In combination with multi-step resonant excitation to Rydberg states using pulsed lasers, the field ionization technique demonstrates increased sensitivity for isotope separation and measurement of atomic parameters over previous non-resonant laser ionization methods. The setup was tested at the Collinear Resonance Ionization Spectroscopy experiment at ISOLDE-CERN to perform high-resolution measurements of transitions in the indium atom from the 5s 2 5d 2 D 5/2 and 5s 2 5d 2 D 3/2 states to 5s 2 np 2 P and 5s 2 nf 2 F Rydberg states, up to a principal quantum number of n = 72. The extracted Rydberg level energies were used to re-evaluate the ionization potential of the indium atom to be 46,670.107(4) cm −1 . The nuclear magnetic dipole and nuclear electric quadrupole hyperfine structure constants and level isotope shifts of the 5s 2 5d 2 D 5/2 and 5s 2 5d 2 D 3/2 states were determined for 113,115 In. The results are compared to calculations using relativistic coupled-cluster theory. A good agreement is found with the ionization potential and isotope shifts, while disagreement of hyperfine structure constants indicates an increased importance of electron correlations in these excited atomic states. With the aim of further increasing the detection sensitivity for measurements on exotic isotopes, a systematic study of the field-ionization arrangement implemented in the work was performed at the same time and an improved design was simulated and is presented. The improved design offers increased background suppression independent of the distance from field ionization to ion detection.were not resonantly excited, allowing ion detection measurements with significantly reduced background. The experiment has so far reached a background suppression factor of 2.5 × 10 8 providing a detection sensitivity down to yields of around 20 atoms per second 25 . The main source of ion background for the technique is due to collisional re-ionization of the atom beam (often also containing a substantial amount of isobaric contamination) with residual gas atoms along the collinear laser overlap volume. For this reason, considerable effort is given to reach ultra-high vacuum pressures (<1 × 10 −9 mbar) in this laser-atom interaction region. The work reported here demonstrates that the incorporation of field ionization, previously tested on continuous atom beams [26][27][28] , can further increase the sensitivity of measurements on bunched atomic beams by also compressing the measurements into a narrow ionization volume. In addition, we show the approach has advantages for measurements of atomic parameters when combined with the multi-step pulsed narrow-band laser excitation. The sensitivity of the approach is further improved by removing the need for a powerful non-resonant laser ionization step, which often contributes substantially to the re-ionizati...

Impact of Oral Lichen Planus on Oral Health-Related Quality of Life: A Systematic Review and Meta-Analysis

“…Unfortunately, these interventions mostly provide the objective evidence of benefits in the majority of clinical studies and can give a misleading sense of improvement in OLP and QoL. Besides, researchers considered the different outcomes while evaluating OH-QoL in OLP in various studies [5]. Furthermore, these studies had no uniform definition for those outcomes and used different QoL tools for measurements.…”

Heterogeneity of outcome measures in the clinical trials of treatment for oral submucous fibrosis—Systematic review

“…Looking at the current scenario in the Oral Medicine specialty, it can be advocated that the problem of heterogeneous outcome measures is confined not only to OSF but also associated with other oral diseases (Lamont et al, 2017; Taylor et al, 2017; Yan et al, 2020). The CONSORT strongly recommends the use of “completely defined pre‐specified primary and secondary outcome measures and validated scales or consensus guidelines both to enhance the quality of measurement and to assist in comparison with similar studies” (Schulz et al, 2010).…”

“…Past literature also demonstrated a positive contribution of PRO to research and clinical practice in monitoring benefits and response to treatment (Chole & Patil, 2018;Rana et al, 2015;Rimal & Shrestha, 2015). As it is of a higher significance, added Looking at the current scenario in the Oral Medicine specialty, it can be advocated that the problem of heterogeneous outcome measures is confined not only to OSF but also associated with other oral diseases (Lamont et al, 2017;Taylor et al, 2017;Yan et al, 2020).…”

Validity and responsiveness of pain rating scales in patients with chronic oral mucosal diseases

“…Apart from psychometric strengths and operational characteristics of outcome measures, there are two additional factors requiring more attention when assessing pain intensity in the clinical trials. One is specific pain intensity domain(s) being assessed, which was found to be reported inconsistently in the literature of chronic pain and COMD including average, worst, or current pain intensity (Jensen et al., 2015; Wiriyakijja et al., 2018; Yan et al., 2020). While a patient's average pain intensity is arguably the most important outcome domain to target for pain control, a recent study comparing average and worst pain scores found that worst pain ratings were more valid and strongly associated with disabilities than other pain intensity domains (Jensen et al., 2015).…”

“…Based upon previous comprehensive reviews, the VAS is the most frequently adopted measure of pain intensity in clinical studies (including RCTs) of COMD (Wiriyakijja et al, 2017(Wiriyakijja et al, , 2018Yan et al, 2020), followed by the NRS. The VAS possesses ratio properties, the highest level of scale measurement hierarchy, allowing for all mathematical operations and analysis on a continuum of pain intensity scores.…”