Effectiveness of the Mysimba Physician Prescribing Checklist (PPC): Focus group to assess understanding, attitude, and behaviour for usage of the PPC and for key safety messages (NB-453 PPC focus groups)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Online focus groups

Study drug and medical condition

• Name of medicine:
  MYSIMBA
• Study drug International non-proprietary name (INN) or common name:
  BUPROPION HYDROCHLORIDE

  NALTREXONE HYDROCHLORIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A08AA62) bupropion and naltrexone

  bupropion and naltrexone
• Medical condition to be studied:
  Overweight

  Obesity

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  24

Study design details

• Main study objective:
  To identify factors that could explain the low awareness and usage of the PPC seen in Study NB-452 as well as the inadequate responses to selected questions on key safety messages.
• Outcomes:
  Among Mysimba prescribers, the study aims to determine prescribers’ awareness and usage of the PPC, and to understand prescribers’ attitudes and agreement with the key safety messages in the PPC. Based on feedback obtained during conduct of focus groups, it will be determined whether changes to the PPC are necessary to improve awareness and understanding of key safety messages.
• Data analysis plan:
  As qualitative research, there are no endpoints. Instead, themes will be sought with the aim of saturation (i.e. no more new themes emerge from discussions). Thematic analysis will be used, which involves searching across discussion verbatim and notes in order to identify, organize, describe repeated patterns. The verbatim of the focus group discussions will be transcribed and analyzed along with field notes constructed by the moderator and assistant moderator, and any notes extracted from the debriefing meeting. Coding will be conducted using a qualitative data analysis software program. Analysis will include systematic coding using constant comparison analysis. Codes will be reviewed to identify themes, opinions, and beliefs that are recurrent (referred to as nodes). Coding will be deductive (pre-set coding scheme, based on hypotheses regarding less well understood safety messages) and inductive (nodes will be generated while examining data). Significant nodes will be grouped.

Documents

Study results

nb-453-csr_23 OCT 23