Questionnaire Context for Scleroderma

Recruiting at 1 trial location

Overseen By Brett D Thombs, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lady Davis Institute

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

798 Participants Needed

Trial Summary

What is the purpose of this trial?

There is concern that self-reported depression questionnaires that contain items assessing somatic symptoms may result in biased scores in people with a chronic disease due to symptoms that overlap with their physical disease. However, it has been shown in previous studies that biases associated with somatic items do not affect total depression scores. The reason for this is still unclear but could be associated with the context in which these items are presented. The goal of this experiment is to learn whether the way people with systemic sclerosis answer somatic items on a depression questionnaire is influenced by the fact that they are aware they are being assessed for depressive symptoms. The main question it aims to answer is: Do people with systemic sclerosis score somatic items differently when they are administered outside the context of a depression questionnaire? Participants will be randomly assigned to complete the 8-item Patient Health Questionnaire as part of their routine cohort assessments either with the items in their standard order or with somatic items presented first and separately from psychological items.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What safety data exists for the treatment evaluated under different names, including Reordered PHQ-8, for various conditions?

The safety of treatments in rheumatology, including biological therapies, is monitored through various registers and databases, which report on adverse events like infections, malignancies (cancers), and cardiovascular events. These systems help ensure that any potential harms are identified and reported to regulatory authorities, contributing to a better understanding of the safety profile of these treatments. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals with systemic sclerosis, a chronic disease that can cause hardening and tightening of the skin and connective tissues. Participants should be able to complete a depression questionnaire as part of their routine assessments.

Inclusion Criteria

Participants must have access to a computer or tablet with internet access

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Randomization

Participants are enrolled and randomized to either the 'Reordered items' arm or the 'Original item order' arm

At enrollment

1 visit (virtual)

Assessment

Participants complete the PHQ-8 questionnaire with either reordered or original item order

At enrollment

1 visit (virtual)

Follow-up

Participants are monitored for differences in PHQ-8 somatic item scores

3 months

1 visit (virtual)

Treatment Details

Interventions

• Reordered PHQ-8

Trial Overview The study tests if changing the order of questions in the PHQ-8, a depression questionnaire, affects how people with systemic sclerosis report somatic (physical) symptoms. Some will answer questions in standard order; others start with somatic items.

Participant Groups

Group I: Reordered items Experimental Treatment 1 Intervention

Participants will receive a routine assessment protocol in which the 3 PHQ-8 somatic items will be presented separately from and prior to the 5 psychological items, without any indication they are part of a depression symptom questionnaire. PHQ-8 psychological items will be presented after the somatic items and with at least 1 measure separating them in the routine assessment protocol. With the exception of these 2 rules, all measures included in the routine assessment will appear in a random order for each SPIN Cohort participant.

Group II: Original item order Active Control 1 Intervention

Participants will complete the standard version of the PHQ-8 which includes both somatic and psychological items, presented in a random order among other measures of the routine assessment protocol. The title of the PHQ-8 will not be included and participants will only see the 8 items presented on a single page in their standard order.

Who Is Running the Clinical Trial?

Lady Davis Institute

Lead Sponsor

Trials

50

Recruited

6,600+

Findings from Research

The study provided minimally important difference (MID) estimates for the UCLA SCTC GIT 2.0 scales in 115 patients with systemic sclerosis, helping to quantify meaningful changes in gastrointestinal symptoms over a 6-month period.

The MID estimates for improvement varied across scales, with the Emotional Well-being scale showing the largest improvement threshold (0.36), while the Fecal Soilage scale had the lowest worsening threshold (0.06), indicating different sensitivities of the scales to changes in health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally important differences of the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument. Khanna, D., Furst, DE., Maranian, P., et al.[2021]

A systematic review of 93 randomized controlled trials involving 31,023 patients revealed a total of 21,498 adverse events (AEs), with 58% of these AEs being suitable for self-reporting by patients, highlighting the importance of patient perspectives in understanding treatment harms.

The study found a lack of systematic reporting on the severity of AEs, with only 9% of trials providing discernible severity grading, indicating a need for standardized frameworks to improve harm reporting in rheumatology research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group. Berthelsen, DB., Woodworth, TG., Goel, N., et al.[2021]

The DANBIO database captured 20 times more adverse events related to biological agents than the Danish Medicines Agency, highlighting its effectiveness in monitoring patient safety.

Infections and hypersensitivity reactions were the most common adverse events, with older age, longer disease duration, and a higher number of previous DMARD treatments identified as risk factors for bacterial infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO). Hetland, ML., Unkerskov, J., Ravn, T., et al.[2019]

The study aims to create a dedicated module within the Hellenic Registry of Biologic Therapies to monitor Systemic Lupus Erythematosus (SLE) patients, focusing on disease activity, severity, and treatment outcomes, which will help assess the long-term efficacy and safety of biologic therapies like belimumab.

Registry-based studies allow for the inclusion of a broader patient population and long-term data collection, which can identify which disease phenotypes respond best to treatments and how co-existing conditions affect therapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Pilot Registry for Monitoring the Efficacy and Safety of Novel Therapies in Patients with Systemic Lupus Erythematosus. Adamichou, C., Flouri, I., Fanouriakis, A., et al.[2020]

Long-term safety and effectiveness of TNF-alpha inhibitors are being monitored through independent, academia-initiated drug registers in several European countries, which include all licensed biological agents and utilize standardized reporting systems for adverse events.

These registers have identified key safety concerns related to infections, malignancies, cardiovascular events, and pregnancy outcomes, highlighting the importance of ongoing collaboration between regulatory authorities, academia, and pharmaceutical companies for effective pharmacovigilance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European biologicals registers: methodology, selected results and perspectives. Zink, A., Askling, J., Dixon, WG., et al.[2013]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Minimally important differences of the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO). [2019]

4. Greece pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Pilot Registry for Monitoring the Efficacy and Safety of Novel Therapies in Patients with Systemic Lupus Erythematosus. [2020]

5. England pubmed.ncbi.nlm.nih.gov

European biologicals registers: methodology, selected results and perspectives. [2013]