A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)

A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)

Type of Study Questionnaire- Development and validation

Information about the Q'SHY:

• The Q'SHY- Questionnaire for Screening of Hypothyroidism is a Patient Reported Outcome (PRO) tool to enable screening for Hypothyroidism in the general population.
• It is a 20-item questionnaire which covers aspects of the symptoms of Hypothyroidism and incorporates the contributory factors from patient history which when combined, provides a robust tool to effectively screen the population.
• The questionnaire content is being created based on a thorough search for relevant literature and encompasses all important aspects for screening purposes

Objectives The objectives of the study are as described in the below points.

1. To develop a questionnaire (Q'SHY) for the identification and screening of subjects with suspected hypothyroidism.
2. To assess the validity of the designed questionnaire by comparing the outcomes of the responses between General population subjects and treatment naïve subjects group with hypothyroidism.
3. The study aims to establish a valid questionnaire with a robust sensitivity and specificity to detect signs and symptoms of hypothyroidism.

Inclusion criteria for Subjects The criteria based on which, subjects in each Arm will be chosen to take part in the survey. Arm1: Subjects from the general population who are naïve to their hypothyroid status.

• Male and female subjects between the age of 18 years and 65 years
• Willing to sign the Subject Authorization Form (SAF) Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve*.
• Male and female subjects between the ages 18 years and 65 years.
• Subjects who had symptoms of hypothyroidism were seen by a physician and diagnosed with hypothyroidism after laboratory testing of Thyroid Stimulating Hormone > 4.5 Milli international units per litre(mIU/L) within 2 weeks from the date of the survey
• Willing to sign the SAF
• Willing to provide their Thyroid Function Test report that was used to diagnose Hypothyroidism. * Treatment naive diagnosed on basis lab and clinical diagnosis within last 2 weeks

Exclusion criteria for subjects Arm 1: Subjects from the general population who are naïve to their hypothyroid status

• Individuals less than 18 years of age and more than 65 years of age.
• Pregnant or lactating females Subjects previously diagnosed with and received treatment for thyroid diseases.
• Subjects not willing to sign the SAF.

Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve

• Individuals less than 18 years of age and more than 65 years of age.
• Pregnant or lactating females
• Subjects previously diagnosed with and received treatment for thyroid diseases.
• Patients on treatment for Thyroid diseases Subjects not willing to sign the SAF.

The above-mentioned criteria will be applicable to both Face validation and Pilot survey.

1. Subjects are divided into 2 arms, with 100 subjects in each arm.

2. Phase -1

   • Arm 1: Sixteen subjects from the general population who are naïve to their hypothyroid status with equal distribution of males and females.
   • Arm 2: Sixteen subjects who are newly diagnosed patients of Hypothyroidism are treatment naïve with equal distribution of males and females

3. Phase -2

   • Arm 1: One hundred subjects from the general population who are naïve to their hypothyroid status with equal distribution of males and females
   • Arm 2: One hundred subjects who are newly diagnosed patients of Hypothyroidism are treatment naïve with equal distribution of males and females

Inclusion Criteria:

• The criteria based on which, subjects in each Arm will be chosen to take part in the survey. Arm 1: Subjects from the general population who are naïve to their hypothyroid status.

  • Male and female subjects between the age of 18 years and 65 years
  • Willing to sign the Subject Authorization Form (SAF) Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve*.
  • Male and female subjects between the ages 18 years and 65 years.
  • Subjects who had symptoms of hypothyroidism, were seen by a physician and diagnosed with hypothyroidism after laboratory testing of TSH > 4.5 mIU/L within 2 weeks from the date of survey
  • Willing to sign the SAF
  • Willing to provide their Thyroid Function Test report that was used to diagnose Hypothyroidism. * Treatment naive diagnosed on basis lab and clinical diagnosis within last 2 weeks

Exclusion Criteria:

• Arm 1: Subjects from the general population who are naïve to their hypothyroid status

  • Individuals less than 18 years of age and more than 65 years of age.
  • Pregnant or lactating females
  • Subjects previously diagnosed with and received treatment for thyroid diseases.
  • Subjects not willing to sign the SAF. Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve
  • Individuals less than 18 years of age and more than 65 years of age.
  • Pregnant or lactating females
  • Subjects previously diagnosed with and received treatment for thyroid diseases.
  • Patients on treatment for Thyroid diseases Subjects not willing to sign the SAF.

The above-mentioned criteria will be applicable to both Face validation and Pilot survey.