Table 3 Use of implementation TMFs in implementation science studies in medicinal products

Huynh et al. [49]

CFIR, PRECEDE-PROCEED, RE-AIM – post-implementation

QUAL

Yes

Full

All domains of RE-AIM: reach, effectiveness, adoption (both levels), implementation and maintenance (both levels).

All domains of PRECEDE: social assessment; epidemiological assessment; educational/ecological assessment administrative and policy assessment and intervention alignment.

All domains of PROCEED: implementation, process, impact and outcome.

All domains of CFIR: innovation characteristics, outer context, inner context, characteristics of individuals and process.

Each domain within each framework was mapped to the REMS assessment FDA’s 2019 REMS guidance to determine the extent to which the domains were reflected in the REMS guidance.

None reported.

Jackson-Gibson et al. [27]

CFIR – implementation

QUAL

Yes

Full

All domains of the CFIR: innovation characteristics, outer context, inner context, characteristics of individuals and process.

The CFIR domains were used as the organizational structure for conceptualizing the study, data collection and analysis.

None reported.

Kalim et al. [54]

TDF – pre-implementation

INSTRU, QUAL, other

Yes

Partial

Six TDF domains: knowledge, skills, environmental context and resources, professional role, social influences and emotions. Domains were chosen through discussion within the research team.

To identify factors that might influence a behaviour of interest (that is, deprescribing). In this study, the interview guide consisted of 19 questions associated with the six TDF domains.

None reported.

Meador et al. [51]

PRISM – pre- and post-implementation

ID, INSTRU, QUAL and QUANT

Yes

Full

All PRISM domains: (1) intervention, (2) implementation and sustainability infrastructure, (3) recipients and (4) external environment.

PRISM constructs used to guide the intervention design were: (1) intervention, (2) implementation and sustainability infrastructure, (3) recipients and (4) external environment. The main PRISM construct that was used to guide the questionnaire: the intervention construct (both the organizational perspective and patient perspective).

None reported.

Nyeland et al. [55]

Study-specific framework: Framework for Evaluation of Effectiveness of Risk Minimization – post-implementation

IMPL, EVAL, other

Yes

Full

All four main domains: (1) data, (2) knowledge, (3) behaviour and (4) outcomes.

To guide identification of data sources (data domain), and process and outcome indicators to evaluate (that is, knowledge, behaviour and outcomes domains)

None reported.

Rogal et al. [53]

OQI – post-implementation

INSTRU

Yes

Full

All domains of OQI: (1) facility structure variables and (2) staffing/culture (for example, psychological safety).

To identify key facility characteristics to measure.

None reported.

Sparks et al. [52]

Diffusion of innovation – post-implementation

INSTRU

Yes

Partial

Only the characteristics of the innovation domain. Constructs measured within that domain included: trialability, observability, relative advantage, complexity and compatibility.

To phrase specific questions in the interview guide.

None reported.

Toyserkani et al. [50]

RE-AIM – pre-implementation

QUAL

Yes

Full

Reach, effectiveness and adoption (both levels), implementation and maintenance (both levels).

The RE-AIM domains were each compared with the content of each of the REMS assessment plans to identify areas for advancing methods for evaluating REMS programs.

Adaptation of the RE-AIM domains: using the established RE-AIM framework (20, 21); the authors created definitions applicable to REMS assessments by adapting from those defined by the framework.

Schafer et al. [56]

CFIR – post-implementation

INSTRU

None reported

Not reported

Insufficient information provided to determine.

To identify barriers and facilitators to implementation of a new digital inhaler for treatment of asthma or chronic obstructive pulmonary disease.

Insufficient information provided to determine.