PMID- 30294713
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240426
IS  - 2509-8020 (Electronic)
IS  - 2509-8020 (Linking)
VI  - 2
DP  - 2018 Dec
TI  - Development of the Diabetes Injection Device Experience Questionnaire (DID-EQ) 
      and Diabetes Injection Device Preference Questionnaire (DID-PQ).
PG  - 43
LID - 10.1186/s41687-018-0068-z [doi]
LID - 43
AB  - BACKGROUND: Previous research has examined patient perceptions of insulin 
      injection devices. However, injectable medications other than insulin are 
      increasingly used to treat type 2 diabetes, including GLP-1 receptor agonists. No 
      patient-reported outcome (PRO) instruments have been developed taking into 
      account the experiences of patients using newer injection devices, which are 
      often different from devices used for insulin. Therefore, the purpose of this 
      qualitative study was to develop two draft PRO instruments focusing on patients' 
      experiences with these newer injection devices (one instrument assessing 
      perceptions of a single injection device, and another assessing preferences 
      between two devices). METHODS: Questionnaire development proceeded in six steps: 
      literature review, interviews with six device experts, concept elicitation 
      interviews with patients (N = 32), preliminary translatability assessment, 
      cognitive interviews with patients (N = 20), and final translatability 
      assessment. RESULTS: Literature review and expert interviews were conducted to 
      inform a concept elicitation interview guide. In concept elicitation in the US, 
      UK, and Germany, patients with type 2 diabetes reported a range of injection 
      features that influenced their perceptions of non-insulin injection devices 
      (e.g., requirements for preparation of the medication/device, issues related to 
      the needle, ease-of-use, portability). Two draft "item pools" were developed 
      based on the literature review, expert interviews, and concept elicitation 
      results. In cognitive interviews, patients recommended minor revisions and 
      indicated that the draft instruments were generally clear, comprehensible, and 
      relevant to their experience with non-insulin injectable medication. The 
      instruments were refined based on the cognitive interviews and translatability 
      assessment, resulting in two questionnaires. CONCLUSIONS: The various steps of 
      qualitative research support the content validity of these new PRO instruments, 
      which are the first developed specifically to assess perceptions of non-insulin 
      injection delivery systems. Despite some overlap with insulin-focused 
      questionnaires, the new instruments are distinct from previous instruments 
      (omitting content that would not be relevant to patients receiving non-insulin 
      injectable treatment, while including content that is not included in the insulin 
      focused instruments). This qualitative research yielded two draft questionnaires 
      that are grounded in patient perceptions and ready for psychometric validation 
      studies with larger samples of patients with type 2 diabetes.
FAU - Matza, Louis S
AU  - Matza LS
AD  - Patient-Centered Research, Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, 
      MD 20814 USA.
FAU - Boye, Kristina S
AU  - Boye KS
AD  - 2Eli Lilly and Company, Indianapolis, IN USA. ISNI: 0000 0000 2220 2544. GRID: 
      grid.417540.3
FAU - Stewart, Katie D
AU  - Stewart KD
AD  - Patient-Centered Research, Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, 
      MD 20814 USA.
FAU - Paczkowski, Rosirene
AU  - Paczkowski R
AD  - 2Eli Lilly and Company, Indianapolis, IN USA. ISNI: 0000 0000 2220 2544. GRID: 
      grid.417540.3
FAU - Jordan, Jessica
AU  - Jordan J
AD  - Patient-Centered Research, Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, 
      MD 20814 USA.
FAU - Murray, Lindsey T
AU  - Murray LT
AD  - Patient-Centered Research, Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, 
      MD 20814 USA.
LA  - eng
PT  - Journal Article
DEP - 20180912
PL  - Germany
TA  - J Patient Rep Outcomes
JT  - Journal of patient-reported outcomes
JID - 101722688
PMC - PMC6153258
OTO - NOTNLM
OT  - Concept elicitation
OT  - GLP-1 receptor agonist
OT  - Injection device
OT  - PRO
OT  - Patient-reported outcomes measures
OT  - Qualitative research
OT  - Treatment preference
OT  - Treatment satisfaction
OT  - Type 2 diabetes
COIS- All methods and materials were approved by an Independent Review Board [Ethical 
      and Independent Review Services (E&I), E&I study numbers 14173-01 and 15099-01], 
      and all patients provided written informed consent prior to completing any study 
      procedures.NAThis study was funded by Eli Lilly and Company (Indianapolis, IN). 
      Kristina S. Boye and Rosirene Paczkowski are employees of Eli Lilly, who provided 
      funding for this study. Louis Matza, Katie Stewart, Jessica Jordan, and Lindsey 
      Murray are employed by Evidera, a company that received funding from Lilly for 
      time spent on this research. All aspects of the study design, interpretation, and 
      manuscript were determined by the authors.Springer Nature remains neutral with 
      regard to jurisdictional claims in published maps and institutional affiliations.
EDAT- 2018/10/09 06:00
MHDA- 2018/10/09 06:01
PMCR- 2018/09/12
CRDT- 2018/10/09 06:00
PHST- 2018/01/12 00:00 [received]
PHST- 2018/08/21 00:00 [accepted]
PHST- 2018/10/09 06:00 [entrez]
PHST- 2018/10/09 06:00 [pubmed]
PHST- 2018/10/09 06:01 [medline]
PHST- 2018/09/12 00:00 [pmc-release]
AID - 68 [pii]
AID - 10.1186/s41687-018-0068-z [doi]
PST - epublish
SO  - J Patient Rep Outcomes. 2018 Sep 12;2:43. doi: 10.1186/s41687-018-0068-z. 
      eCollection 2018 Dec.