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It could be argued that more participants should have been included during this phase of the instrument development.
All participants for each phase of the instrument development were patients age 18 years and older with the chronic conditions of diabetes, hypertension, heart disease, or heart failure.
However, this was also a factor of the rare nature of HAE and the ability to recruit sufficient numbers of independent patients in each country for each phase of the instrument development.
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The overall sample across phases of the instrument development consisted of 446 children.
Each step of the instrument development and testing followed a revision of the instrument.
Here, we report the linguistic and psychometric validation of the Welsh BDI-II and highlight the value of embedding early stage validation within the instrument development phase.
141 individuals undergoing genetic testing were approached and consented to the instrument development phase of the study (Phase I).
The role of risk mitigation during the instrument development is presented, in combination with the causes and impacts on performance verification and instrument qualification, of a number of anomalies, that showed up in the hardware phase.
Then, Section 3 provides the instrument development, measuring instrument, and techniques of data analysis adopted in this study.
Omitting this significant group from the qualitative phase of instrument development risks missing important aspects of the conceptual basis of the instrument, and may thus compromise its content validity.
Although there will be some children younger than 8 years of age who can complete electronic diaries, we wanted to ensure that most children were able to understand and complete the instrument for the early phase of instrument development.
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