Background Patient-reported outcomes (PROs) are important in monitoring and making treatment decisions.Recently,we reported that the translation of“tender points” in the fourth question of the Turkish version of BASDAI was not correctly understood,and replacing this question with an entheses examination (BASDAI-Q4) decreased the score (ΔBASDAI:0.99,p<0.0001,95% CI0.54–1.44).1
Objectives We report here the results of an investigator initiated clinical trial using a self-developed mobile phone application (MPA)2 to overcome the problem of untranslability.
Methods Out of 135 invited 95 axSpA patients participated.Initially,BASDAI self-report forms (BSRF) were administered.Thereafter,patients were randomized into two groups (2:1).GroupA completed a second set of BSRF after using the MPA with embedded videos defining terms and grading for each domain.GroupB completed a second set of BSRF under guidance of an inexperienced family physician (FP).A third set of BSRFs were completed by GroupB with the same FP after he went through the MPA.Afterwards,an entheses examination (EE) was performed by a blinded rheumatolgist and patients graded enthesis pain between 0–10.StandartQ4 was replaced with the EE scoring (BASDAI-Q4).Patients older than 45 years of age were excluded.
Results Fifththree male (%55.7) and 42 female (%44.3)patients,with a mean disease duration of 13 years (SD=8.7)were studied.Sixtyfour and 31 patients were randomized to Groups A and B, respectively.Nine patients reported the Q4 as“not understood”.32 patients had no enthesitis on EE,but of those only 21 scored“0” for Q4 during the unassisted-PRO.Eleven reporting no enthesitis had so on EE.In GroupA,out of six“not understood” responders forQ4,five reported enthesitis after MPA assistance and four had enthesitis at the final EE.Nineteen patients had no enthesitis on physical examination,but of those only 12 scored“0” for Q4 during the unassisted PRO,and an additional nine scored“0” forQ4 after MPA assistance.Six out of seven patients reporting no enthesitis,but with enthesitis on EE reported,enthesitis after MPA assistance.In GroupB,scoring forQ4 was similar after both the unassisted- and FP's first assistance PRO.Out of four “not understood” responders for Q4,two reported enthesitis after the second assistance of FP and both had enthesitis at the final EE.Six patients had no enthesitis on EE,but of those only4 scored“0” for Q4 during the unassisted-PRO,and an additional two scored“0” for Q4 after second FP-assistance.Two out of four patients reporting no enthesitis,but with enthesitis on EE,reported enthesitis after second FP-assistance.Mean BASDAI was significantly higher in both groups then BASDAI-Q4 (Group A=3.97±1.95 vs. 2.84±1.98, p<0.0001,95% CI0.58–1.52, Group B=3.81±2.05 vs. 2.98±2.25, p<0.0001,95% CI0.48–1.31). In both groups, MPA for both, patients and FPs resulted in more reliable overall BASDAI scores with BASDAI-Q4 as the gold standard (Group A=3.05±2.25 vs. 2.84±1.98, p=0.081, 95% CI0.71–1.45, Group B=3.21±1.87 vs 2.98±2.25, p=0.075,95% CI0.71–1.63).
Conclusions Mobile applications may improve the quality of collected data in cases of untranslability even in previously validated PROs.
Disclosure of Interest None declared