The aim of our study is to develop a new PRO instrument for acute and chronic wounds. Our 3-phased approach involves a qualitative study, an international field-test and a psychometric study. Patients, healthcare providers and other stakeholders…
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
- Epidermal and dermal conditions
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Interviews, coding and item generation: The study RA will conduct the
interviews (see Table 3 for Interview Guide), which will be tape recorded and
transcribed verbatim. The data will be coded using a line-by-line approach
where all concepts are labelled with a major and minor COI. Coding will take
place as soon as possible after an interview so that findings can inform
subsequent interviews in an iterative fashion. Item generation will also take
place concurrently with data collection. This process will occur within Excel.
Codes (patient quotes) and their major and minor COI will be moved from the
Word document into Excel columns. Patient characteristics (e.g., age, health
condition, wound type, healing phase) will also be inserted into Excel columns.
These characteristics will make it possible for us to identify potential core
items (common across wound type) and unique items (specific to a wound type).
For each code, preliminary items will be generated and each will be assigned a
descriptor to capture the essence of what it measures. Items will retain the
wording used by patients and have the lowest possible grade reading level to
ensure the content resonates with patients and is comprehensible.
Secondary outcome
After completing phase 1 we will continue with phase 2 and 3 (not part of this
application). We anticipate that the WOUND-Q will provide the international
medical community with meaningful, precise and reliable feedback on important
patient-centered outcomes and the potential for widespread use in both clinical
and research settings.
Background summary
Each year, millions of individuals require treatment for acute and chronic
wounds. Wounds represent an important health problem and challenge to patients,
healthcare professionals and healthcare systems alike. Wounds vary greatly in
terms of their impact on patients* in terms of recovery and return to usual
activities and health-related quality of life (HRQL). Currently, there is scope
to develop a comprehensive patient-reported outcome (PRO) instrument for acute
and chronic wounds to measure patient outcomes and experience of wound care. A
PRO instrument is needed because outcomes, such as how a patient feels and
functions, are concepts of interest (COI) best assessed by the patient.
Patients also have important things to say about their experience of wound
care. Such information can serve as quality metrics.
Study objective
The aim of our study is to develop a new PRO instrument for acute and chronic
wounds. Our 3-phased approach involves a qualitative study, an international
field-test and a psychometric study. Patients, healthcare providers and other
stakeholders will be integrally engaged in content development and evaluation.
The current proposal is for the phase 1 qualitative study only. We will conduct
patient interviews to identify important COI and to create a conceptual
framework and set of independently functioning scales for this new PRO
instrument, i.e., WOUND-Q. The new questionnaire will be shown to patients in a
series of cognitive interviews. We will use the findings to ensure the scales
are as easy as possible to understand and cover all important issues from the
patient perspective. Healthcare providers will be invited to provide feedback
to ensure all clinically important issues are captured. The scales will be
revised and pilot tested prior to finalizing. In phase 2 (not part of this
application), we will field-test the WOUND-Q in a large cross-sectional
heterogeneous sample of patients. Data will be analyzed to identify the best
subset of items to retain in each scale, based on their performance against a
standardized set of psychometric criteria. At this point, the WOUND-Q will be
available for distribution. In phase 3, we will perform a supplementary
psychometric study to examine responsiveness.
Study design
This is a qualitative study that involves the following steps:
1) semi-structured interviews with patients to collect data to inform the
development of a hypothesized conceptual framework and set of scales with
items;
2) input from healthcare providers who care clinically for the patients of
interest, in order to ensure the scales reflect all clinically important issues
from their perspective; and
3) cognitive interviews with patients to refine the preliminary set of scales
and items ensuring they contain maximum content validity and are easy to
comprehend. Our study takes an applied health services research approach called
Interpretive Description.
This approach aims to generate knowledge relevant for the clinical context and
presumes there is theoretical knowledge, clinical knowledge and a scientific
basis informing a study.
Interviews: Given that qualitative research aims to investigate what underlies
aspects of behavior, and that it is concerned about richness rather than
representativeness of data, it requires smaller, focused samples instead of
large, random samples. For qualitative interviews, evidence suggests that data
saturation can occur within 12 interviews, with themes arising as early as six
interviews. Given clinical differences in our sample, we plan to conduct
approximately 60 interviews (15 in the Netherlands) or as many as are necessary
to reach saturation, i.e., no new content identified. We will purposely recruit
a heterogeneous sample of patients.
Cognitive interviews using think-aloud method: Sample size requirements for
cognitive interviews are variable, with the number of interviews a function of
the complexity of the PRO instrument and the diversity of the population.
Willis suggests up to 10 participants are sufficient, but we will conduct 30
interviews or as many as are necessary to reach saturation. The interviews will
be conducted in three rounds of 10 participants to provide the investigative
team the opportunity to make changes between rounds.
Study burden and risks
-
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
patients aged 18 and older with any type of chronic wound (> 3 months) anywhere on their body;Patients will be recruited from the out-patient clinic of the Plastic Surgery department, Catharina Hospital Eindhoven. Sampling will be purposeful and will consist of a heterogeneous maximum variation sample to ensure we hear as many patient stories as possible. Included patients will have are those who have received treatment for an acute or chronic wounds. ;We will strive to recruit a sample that varies by gender, age, ethnicity, type of acute or chronic would, location of wound on body, phase in the wound healing process and risk of poor outcome including older age, smoking having diabetes or being obese.
Exclusion criteria
Patients who do not speak Dutch and/or have cognitive or developmental delay will be excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58696.100.16 |