CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT The conducted tests were not Randomized Controlled Trial in nature (see 1a). The paper compares the results of offline tests in series (i) with webbased results from series (ii) and (iii), so it can be assumed that "(i) audiologist-performed tests on a clinical audiometer" is an equivalent of the comparator, while "(ii) self-tests done on a specially calibrated computer under the supervision of an audiologist" and (iii) "self-tests conducted at home" are equivalents of intervention. 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Level of human involvement: "(i) audiologist-performed tests. ", "(ii) self-tests . under the supervision of an audiologist", "(iii) self-tests conducted at home". 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT The trial was closed, web-based and self-assessed with face-to-face components functioning as a comparator. Subjects were recruited offline: "The research was carried out on the group of 51 subjects selected from among patients of an audiology outpatient clinic". Face-to-face components: "(i) audiologist-performed tests on a clinical audiometer". 1b-iv) RESULTS section in abstract must contain use data "From the group of 51 patients examined in the first two series, the series (iii) was self-administered at home by 37 subjects (73%)" 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials The conducted trial was not Randomized Controlled Trial (compare 1a). Its main objective was to determine and analyse the measurement error of the hearing threshold in web-based studies. On the basis of the conducted analysis the following conclusion was formulated: "The obtained results confirm the possibility of applying web-based pure-tone audiometry in screening tests. " INTRODUCTION 2a-i) Problem and the type of system/solution The problem: hearing impairment. Type of solution: stand-alone intervention ("self-administered hearing tests at home", "pure-tone audiometry conducted on a PC ", "self-administered web-based pure tone audiometry"). Patient population and goals of the intervention: General population, in particular / with the focus on persons with hearing problems. However, the target group will depend on measurement error which needs to be evaluated. ("The potential application of pure-tone audiometry conducted on a PC depends on the value of the measurement error. The PC-based test will not substitute the clinical pure-tone audiometry. However, it can be applied for conducting self-administered check-ups, in cases of limited access to clinical devices, e.g. at the general practitioner. Alternatively, it can be used as an initial tele-medical examination combined with a survey, which will help determine the direction of future treatment.") 2a-ii) Scientific background, rationale: What is known about the (type of) system "The remote examinations of hearing conducted with the use of PC have been carried out for about 10 years [1]. These examinations can be divided into surveys [2, 3, 4] and examinations done with the use of sound signals. The sound signals can be generated through a dedicated external device connected to a PC, usually an audiometer [5, 6] or a PC sound card [3, 4, 7, 8, 9, 10, 11, 12]. Among hearing examinations we can distinguish standard screening tests [3, 7, 11, 12] and examinations such as pure-tone audiometry [4, 5, 6, 8, 9, 10], which provide additional information. The hearing screening tests done remotely with the use of a PC sound card are most often in the form on a speech-in-noise test [3, 7, 11, 12]. The speech-in-noise test is preferred over survey [3] as it improves the detection of hearing impairment among the population [7], especially after introducing a low-pass noise [12]. The evaluation of validity of pure-tone audiometry conducted in similar conditions, i.e. with the use of a PC sound card and ordinary headphones [8, 9, 10] is ambiguous and depends on the adopted solutions, which include e.g. calibration, hearing threshold evaluation method, presence or lack of a person supervising the test. In the supervised tests the mean error concerning the determination of a hearing threshold on a specially constructed and calibrated PC-based device was below 2.3dB [8], in unsupervised tests conducted after computer calibration performed by a person with a good hearing the greatest error occurred at the frequency of 2 and 4kHz and was −5.6dB and −5.1dB respectively, with standard deviation of 8.29dB and 6.9dB [10]. In unsupervised tests conducted without calibration the maximum mean difference occurred at the frequency of 500Hz and was 11.3dB [9]. " METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio "The aim of the research was to identify the measurement error connected with determining the hearing threshold conducted by means of selfadministered web-based pure tone audiometry, as well as identify and analyse factors affecting its value. " 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons