Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04798911 |
| Other study ID # |
226947 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 12, 2018 |
| Est. completion date |
July 21, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
University College, London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Patients with some long-standing rheumatic diseases have stated that they want to be fully
informed about their disease as they find it 'more scary not to know' about possible
complications and consequences. Patients who have the information they want about their
disease can fully take part in decisions about their own health creating a partnership with
their doctor. Sjögren's Syndrome (SS) is a multi-system, long-standing rheumatic disease that
has a negative impact on the daily life of patients. A common presentation of this disease is
dry mouth, which can make talking, eating and swallowing more difficult.
Project aims: We aim to ask patients with SS what information they think it would be
important to know about SS. We plan to create a questionnaire that can be used by doctors to
help deliver the right information to patients at hospital visits.
Timescale: This project will take 36 months to complete. Clinical relevance: This
questionnaire could be used in daily practice. It could help patients cope with their
disease, take part in treatment decision and reduced uncertainty and distress.
Description:
This is a PhD student project that will be undertaken in 2 distinct phases.
Phase 1:
Determination of Informational Needs (Months 0- 9)
- Qualitative interviews with patients with SS
- Interview transcriptions and thematic analysis
Subjects The perspective of the patient is critical in the determination of the informational
needs of patients with SS. Qualitative interviews will be conducted patients with SS. Due to
the depth of rich data that can be derived from focus groups we plan on using this method of
qualitative interview.
Streiner and Norman proposed that each focus groups would contain 6 to 12 patients.
Approximately 40-50 patients with SS will be recruited for the qualitative interviews. These
patients will be identified from the Oral Medicine clinics of the UCLH Eastman Dental
Hospital. Inclusion criteria will include:
- Adult patients with a diagnosis of primary SS as per the 2002 American-European
Consensus Group (AECG) classification criteria, or
- Adult patients with a diagnosis of primary SS as per the 2016 American College of
Rheumatology/European League Against Rheumatism classification criteria
- Adult patients who are able to consent to being involved in the study
- Willingness to participate in focus groups
- Fluency of the English language to allow participation in focus groups
Research methods:
These focus groups will take the form of semi-structured interviews, using a topic guide as a
general framework during the interview. The topic guide will consist of a list of topics of
interest, developed by -
- informal interviews / discussions with patients and clinicians
- clinical observation The order of the items on the list will not be fixed and,
therefore, will allow for flow of the conversation.
With the qualitative interviews data collection is carried out and analysed in stages. This
process continues until data saturation has been achieved. Data saturation is deemed to have
been achieved when no new information or themes emerge. Once data saturation has been
achieved the digital recordings of the focus groups will then be transcribed to allow
analysis of the data.
Data analysis:
Although multiple approaches to qualitative data analysis exist, three are more commonly
used, namely thematic analysis, grounded theory and framework analysis. Thematic analysis
will be used and the emergent themes will allow for the determination of the informational
needs of patients with SS.
Phase 2 Development of the informational need instrument for SS [SS-INQ] (Months 9-32)
- Adaptation of TINQ-BC for use in patients with SS - generation of relevant questions
using themes from Phase 1 qualitative study (removal of those solely related to breast
cancer from TINQ-BC) by the expert group
- Pilot testing of SS-INQ for content and readability will be done via focus groups whilst
structural validity will be explored using factor analysis
- Testing of SS-INQ for reliability - internal consistency reliability and test-retest
reliability Subjects (including justification for sample size) The number of experts
involved in item generation of a new instrument varies widely in the literature, from as
few a 3 to as many as 24. With no established consensus on the critical number of
persons involved it is our intention to establish a 5 to 7 person expert group,
consisting of Rheumatologists, Oral Medicine Clinicians and Ophthalmologists, to be
involved in the generation of questionnaire items.
A previously mentioned we propose to hold focus groups with 6 to 12 patients per group.
Approximately 12 to 24 patients with SS will be recruited for content validity and
readability.
Tinsley and Tinsley (48) suggest a ratio of about 5 - 10 subjects per question in the
instrument up to 300 subjects when carrying out factor analysis. TINQ-BC consists of 52
items, therefore assuming that the SS-INQ will consist of a similar number of items a minimum
of 260 patients will be required to determine the structural validity of the newly developed
instrument using factor analysis.
The COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN)
checklist can be used to determine the methodological quality of measurement tools. According
to Mokkink et al 50-100 patients to achieve a good to excellent quality assessment rating
when determining internal consistency reliability and test-retest reliability.
Research methods and data analysis:
Due to the importance of an underlying structural framework in the development of a
questionnaire we plan to adapt an existing informational needs questionnaire, which was
developed used Lazarus and Folkman's Theory of Stress and Coping conceptual framework.
TINQ-BC was developed in the late 1990s due to a lack of knowledge about the amount and type
of information patients with a recent diagnosis of breast cancer may require. In a recent
review TINQ- BC was deemed to be a tool that should be used as a model in the development of
future informational needs questionnaires. The themes derived from the qualitative interviews
will be used to populate the instrument ensuring it is specific to SS and reflective of the
patients' informational needs.
The SS-INQ instrument will then be tested for content and structural validity, readability
and reliability as follows:
- Content validity and readability: content validity refers to the extent to which the
items in the questionnaire reflect the facets of the domain or construct they are
proposed to represent. Each facet of the domain should therefore be represented by at
least one item in the questionnaire.
- Structural validity: factor analysis will be conducted to determine the dimensionality
of the instrument. The goal of factor analysis, according to Kin and Mueller, is 'to
represent a set of variables in terms of a smaller number of hypothetical variables'.
- Internal consistency reliability: defined as 'the precision of a scale, based on the
homogeneity of the scale's items at one point in time', will be determined by
calculating Cronbach's Alpha coefficient. Alpha values can range from 0.0 to 1.0. It
refers to the degree to which statements in SSINQ correlate with each other. According
to De Vellis and Streiner and Norman levels between 0.7 and 0.9 are desirable.
- Test-retest Reliability: Test-retest reliability measures reliability of the instrument
selected over time. In general instruments are administered at two points in time. A
period of 12 to 14 days is generally considered an acceptable retest interval. Anastasi
and Urbina suggested that the value of the intraclass correlation coefficient (ICC)
should generally be > 0.8 . We will administer the chosen instrument at two time points
14 days apart. The ICC will then be calculated.
Final analysis 32-36 months.
