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Table 1 Elements of implementation fidelity for FCM administration adapted from Carroll et al. elements and modified by Hasson Henna

From: Implementation fidelity of intravenous ferric carboxymaltose administration for iron deficiency anaemia in pregnancy: a mixed-methods study nested in a clinical trial in Nigeria

Elements and sub-elements of implementation fidelity

Definition

Method/measurement for Implementation fidelity

1. Adherence

The degree to which FCM is delivered as intended

Quantitative

Content

The necessary steps (active ingredients) in administering FCM

Number of FCM administration with complete adherence to the active ingredient of FCM administration (the essential (n = 10) components) / total number of FCM administration observed (n = 254)

Coverage

The proportion of eligible participants who actually received FCM administration

Total number of FCM administration observed/ Number of participants eligible for FCM administration

Dose

Amount of FCM administered as intended

Number of FCM administrations that adhered to the right amount (20 mg/kg) / total number of FCM observed

Duration

Regularity of the time to monitor for adverse events post-FCM administration

Number of FCM administered that adhered to the right duration of time (30 min) for monitoring post-administration / total number of FCM observed

2. Influencers of fidelity

Factors that influence the degree of implementation fidelity

Qualitative

Intervention complexities

The comprehensiveness of FCM description and the complexity associated with its administration

In-depth interviews (IDI)

Facilitation strategies

Strategies provided to optimise and standardise implementation fidelity,

Quality of delivery

The degree to which FCM is delivered in a way appropriate to achieving its desired outcome

Participant’s responsiveness

The acceptance and engagement of the SHP to FCM administration

Context

Structural, cultural, organisational / group factors that influence FCM administration

  1. SHP Skilled health personnel, FCM ferric carboxymaltose