Table 2 Characteristics of implementation science studies for medicinal products citing the use of an implementation TMF

Huynh et al. [49]

To evaluate FDA REMS assessment plans and FDA 2019 REMS guidance using established implementation science frameworks and identify opportunities for strengthening REMS evaluation

n = 23 REMS assessment plans for products that had an ETASU-type REMS

n = 674 REMS assessment measures

No specific target condition

Products with REMS assessment plans

Retrospective content analysis using three established implementation science frameworks of REMS assessment plans was conducted for REMS programs approved by the FDA between 1 January 2014 and 31 December 2018.

Framework constructs were mapped to REMS assessment categories.

Post-marketing

Jackson-Gibson et al. [27]

To evaluate implementation and program outcomes of the DREAMS intervention, including uptake and adoption of PrEP in Seme Sub-County, Kisumu, Kenya

n = 15 key informant interviews

with Pamoja Community-Based Organization staff, healthcare providers and community leaders

n = 40 participants in focus group discussions involving Luo-speaking young women (between 16 and 24 years of age) receiving PrEP and peer mentors

HIV

HIV PrEP

Cross-sectional study involving qualitative key informant interviews and focus groups with patients and mentors.

Post-marketing

Kalim et al. [54]

To explore the factors that influence doctors when deprescribing FRIDs in a hospital setting

n = 18 physicians from a large academic teaching hospital in Dublin, Ireland

Reduction of falls and fall-related injuries

Fall-risk-increasing drugs, including loop diuretics, psychotropics, opioids, antidepressants, digoxin, antiepileptics and oral hypoglycemics

Cross-sectional study involving semi-structured interviews with consultant geriatricians and hospital doctors.

Post-marketing

Meador et al. [51]

To identify/address provider-perceived barriers to optimal statin prescribing and use

To use study results to inform development of interventions to help centres

n = 32 clinical care providers (n = 18 physicians; n = 7 physician assistants; n = 3 nurse practitioners; n = 1 clinical pharmacist; n = 1 nurse/RN; n = 2 other)

from 21 health centres within 5 health centre-controlled networks across 11 US states and District of Columbia

Cardiovascular disease, specifically, statin-eligible cardiac high-risk patients

Statins

Cross-sectional survey of clinical providers.

Post-marketing

Nyeland et al. [55]

To develop a framework for evaluation of risk minimization interventions tailored to the needs of the Danish healthcare system

To review its features when applied to historical data as part of a case study involving dabigatran

n = 21 221 Danish patients with non-valvular atrial fibrillation who had their initial prescription of dabigatran (110 or 150 mg BID doses) during the period 1 August 2011 to 30 June 2014

Non-valvular atrial fibrillation (stroke)

Dabigatran

Retrospective data review using interrupted time series analysis involving linked databases, including the Danish: (1) civil registration system, (2) national patient register and (3) national prescription drug register.

Post-marketing

Rogal et al. [53]

To assess implementation strategies that facilities used to implement case reviews

To determine whether those strategies differed for facilities receiving policy notices including additional oversight from the VA national office providing implementation support

To examine the association between implementation strategies, respondent characteristics, facility characteristics and case review completion rate

n = 89 veterans administration healthcare facilities, including rural (14%) and urban/suburban (86%)

Opioid misuse and overdose

Opioid analgesics

Randomized trial in which participating facilities were randomly assigned to receive 1 of 2 versions of a policy notice (one with oversight provisions and one without such provisions). A survey of facilities was then conducted.

Post-marketing

Sparks et al. [52]

To understand the level of awareness regarding the USP’s new patient-centred label guidelines

To determine what barriers and facilitators exist to adopting these new label guidelines among key stakeholders, including pharmacists, pharmacy managers, prescribing physicians and software vendors

n = 5 pharmacists (n = 2 chain pharmacies, n = 3 independent pharmacies)

n = 7 pharmacy managers (n = 3 at independent pharmacies, and n = 4 at chain pharmacies)

n = 2 physicians

n = 2 pharmacy software vendor representatives

All diseases and medical conditions requiring prescription drug treatment

All prescription drugs

Cross-sectional study involving semi-structured interviews with pharmacists and pharmacy managers.

Post-marketing

Toyserkani et al. [50]

To characterize REMS assessment plans using the RE-AIM framework

To identify areas for advancing methods for evaluating REMS programs

n = 18 REMS assessment plan for REMS programs approved by the FDA between 1 January 2014 and 31 December 2018

n = 520 discrete measures in the REMS assessment plans

Cancers, multiple sclerosis, opioid dependence, acute pain, plaque psoriasis, opioid use disorder, generalized hypoactive sexual desire disorder, lipodystrophy, endogenous testosterone deficiency,

polycystic kidney disease, phenylketonuria,

polyneuropathy, paroxysmal nocturnal hemoglobinuria

Clozapine; alosetron, sodium oxybate; vigabatrin; emtricitabine/tenofovir disoproxil fumarate; metreleptin; alemtuzumab; parathyroid hormone; daclizumab; brodalumab; tisagenlecleucel; axicabtagene ciloleucel; pegvaliase; ravulizumab; testosterone undecanoate; fentanyl transdermal systems; flibanserin; tolvaptan; inotersen; sufentanil

A content analysis of REMS assessment plans.

Blinded reviewers categorized each REMS assessment measure to a RE-AIM framework dimension, adjudicated their application and refined the adapted dimensions’ definitions. Dimensions were mapped to REMS assessment guidance categories.

Post-marketing

Schafer et al. [56]

To explore the real-world experiences of specialists who implemented a novel digital inhaler in clinical practice

Immunologists/allergist (n = 16)

Pulmonologist (n = 1). Participants: US specialists who had prescribed a novel digital inhaler to ≥ 1 patient with asthma or chronic obstructive pulmonary disease

Patient with respiratory problems on inhaler treatment

Albuterol sulfate

Cross-sectional web-survey and qualitative interviews.

Post-marketing