Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621420
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Peyronie Disease Questionnaire PDQ Turkish Validation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Peyronie Disease Questionnaire PDQ Turkish Validation
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Turkish PDQ
Brief Summary:
The purpose of the present study is to translate into the Turkish and a perform a validation of the Turkish version of a PDQ and to ensure the use of Turkish validation of the PDQ in clinical use and studies
Detailed Description:
The Peyronie Disease Questionnaire PDQ The PDQ is a 15-item self-administered disease-specific and multidimensional printed format instrument developed to quantify the psychosexual symptoms of PD The PDQ includes three scales psychological and physical symptoms 6 items penile pain 3 items and symptom bother 4 scored items and 2 yesno questions The psychological and physical symptom domain has a 5-level Likert scale ranging from none to very severe Patients must complete items on the penile pain domain thinking about the last 24 h and a numeric scale ranging from 0 to 10 was used to evaluate its severity Thesymptom bother domain has a 5-level Likert scale not at all bothered a little bit bothered moderately botheredvery and extremely bothered The sum of all responses is calculated and given separately for each domain as long as a total PDQ score is not intended Higher domain scores indicate a greater negative impact being the score range from 0 to 24 for psychological and physical symptom from 0 to 30 for penile pain and from 0 to 16 for symptom bother
The PDQ translation procedure followed a structured method to ensure reliability The translation method included the following steps 1 Translation of the original questionnaire to Spanish by two independent professional translators 2 Merging both translated versions by the research team 3 Back translation of the merged version by two native English professional translators 4 Review of the different back-translated English versions with the original questionnaire by the research team 5 Revising the conceptual equivalence with the original performed by both the translators and the researchers 6 Testing the translated questionnaire in a pilot group of 30 patients 7 Results analysis of the pilot test and completion of translation by the research team 8 Final editions of the questionnaire 9 Final report of the researchers
This study included a total of 60 patients with a diagnosis of PD excluding those who had previously received invasive treatment Males over 18 years of age and patients diagnosed with Peyronie disease who had not undergone surgery were included in the study
The test-retest reliability of the PDQ-I and the internal consistency of its subscales will be assessed Intraclass correlation coefficients ICC will be calculated to assess the degree of association between the PDQ subscale scores Paired Student t-tests will be used to assess whether there are statistically significant score changes between T1 and T2 Internal consistency reliability will be assessed by calculating Cronbachs alpha for each of the three PDQ subscales
The PDQ translation procedure followed a structured method to ensure reliability The translation method included the following steps 1 Translation of the original questionnaire to Spanish by two independent professional translators 2 Merging both translated versions by the research team 3 Back translation of the merged version by two native English professional translators 4 Review of the different back-translated English versions with the original questionnaire by the research team 5 Revising the conceptual equivalence with the original performed by both the translators and the researchers 6 Testing the translated questionnaire in a pilot group of 30 patients 7 Results analysis of the pilot test and completion of translation by the research team 8 Final editions of the questionnaire 9 Final report of the researchers
This study included a total of 60 patients with a diagnosis of PD excluding those who had previously received invasive treatment Males over 18 years of age and patients diagnosed with Peyronie disease who had not undergone surgery were included in the study
The test-retest reliability of the PDQ-I and the internal consistency of its subscales will be assessed Intraclass correlation coefficients ICC will be calculated to assess the degree of association between the PDQ subscale scores Paired Student t-tests will be used to assess whether there are statistically significant score changes between T1 and T2 Internal consistency reliability will be assessed by calculating Cronbachs alpha for each of the three PDQ subscales
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None