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Table 1 Global framework – implementation criteria for pilot test

From: Reporting of context and implementation in studies of global health interventions: a pilot study

Criterion Source Rationale or clarifying statement Example
Criterion #1 - Intervention characteristics: Intervention/Program source CFIR, Damschroder, [5] Is the intervention/program externally or internally developed? An intervention/program may be internally developed as a good idea, a solution to a problem, or other grass roots effort, or may be developed by an external entity (such as a foundation or a NGO). Interventions or programs that arise internally from the populations who will be impacted are sometimes more sustainable than externally developed programs dependent on external funding. The perceived legitimacy of the source may also influence implementation. ‘The ViSION project involved a partnership among Save the Children/US ([SC] Hanoi and Westport, Conn., USA), the USAID-funded LINKAGE Project (Washington, D.C.), Emory University Rollins School of Public Health (Atlanta, Ga., USA), and the Research and Training Center for Community Development (RTCCD, Hanoi). The SC Viet Nam field office developed the program model and implemented it through government partners. (Indicates this is externally funded).’
Criterion #2 - Intervention characteristics: A description of why the intervention was hypothesized to have an impact on the outcome, according to theory. CReDECI, Mohler also mentioned in Michie, [6, 7] The theoretical basis of the intervention should be clearly stated. This includes the theory on which the intervention is founded as well as, if available, empirical evidence from studies in different settings or countries. ‘Previously, we showed no effect of direct education by health workers on infant care practices and care-seeking behavior after delivery. In view of the Bolivian model, we thought that a participatory approach might have more effect on perinatal care practices and might increase consultation for difficulties in pregnancy and the newborn period. Two key elements distinguished our approach from conventional health education. First, women’s groups looked at demand-side and supply-side issues. Second, the approach emphasized participatory learning rather than instruction.’
Criterion #3 - Intervention characteristics: Rationale for the aim/essential functions of the intervention/program’s components, including the evidence whether the components are appropriate for achieving this goal. CReDECI, Mohler, also mentioned in Michie, [6, 7] This differs from the need to articulate the theory behind the intervention in that the theory posits the general principles (such as Rogers Diffusion of Innovation) while this item is about specific components of the intervention and the effects of the component on specific targets. ‘Our preliminary qualitative field work showed that individual behaviours were influenced by collective behaviours and social norms, and sustained by a complex, multilevel network of relationships within the community. We therefore developed a multilevel strategy targeting: community stakeholders, newborn stake holders, and households with immediate support groups. At each level, the target group consisted of individuals who were identified to have key roles as influencers, decision-makers, supporters, and practitioners of newborn care and normative behaviour within the community. The support of community stake holders such as village heads, community leaders, respected members, priests, and teachers was crucial in building trust with the community and ensuring acceptance of the program. The newborn stakeholder target group included traditional newborn-care providers and birth attendants, unqualified medical practitioners, and, to a lesser extent, health system workers, some of whom had strategic access to the newborn and mother during post-partum confinement, were perceived by the community as domain experts, and played an active part in sustaining targeted practices. Health system workers such as auxiliary nurse midwives were engaged only at the community level as part of newborn stakeholder group meetings in order to keep contamination of the intervention into control clusters to a minimum. The household target group included the pregnant woman or mother, who was the primary care provider, but usually not empowered to make decisions; the mother-in-law, who was usually the key decision maker on newborn-care practices; other female members who played supportive roles; and male members, including the father-in-law and husband, who controlled access to the household, made financial and logistical arrangements, and influenced care-seeking decisions. The family’s immediate support group included neighbors and relatives who influenced family behaviors and helped with deliveries.’
Criterion #4 - Intervention Characteristics: Detailed description of the intervention/program WIDER as described in Michie, [7] None beyond those stated in each criterion. None.
The detailed description should include:
a. Characteristics of those delivering the intervention/program (such as a nurse or lay health worker)
b. Characteristics of the recipients
c. The setting
d. The mode of delivery (such as face-to-face)
e. The intensity of the intervention/program (such as the contact time with participants)
f. The duration (such as the number of sessions and their spacing interval over a given period)
g. Adherence or fidelity to delivery protocols
h. A detailed description of the intervention/program content provided to each study group
Criterion #5 - Intervention Characteristics: Costs of the intervention and costs associated with implementing the intervention CFIR, Damschroder, CReDECI, Mohler, [5, 7] The cost of the intervention and implementation can influence the adoption and sustainability; interventions may be more difficult to sustain if they were supported as part of a research study. No good reporting examples were identified.The closest examples of good cost reporting mentioned cost without stating whether it was program or research.
Criterion #6 - Outer Setting: External policies and incentives CFIR, Damschroder, [5] How does the health service, intervention, or program relate to country and global health goals? Is the program part of a larger strategy? If so how is it strategically aligned? A country's health policies may influence the implementation of a particular intervention or program. We found we could not operationalize this criterion, and hence, identified no examples of good reporting
Criterion #7 - Population needs CFIR, Damschroder, [5] The extent to which population needs, as well as barriers and facilitators to meet those needs, are accurately known and prioritized. This could include population-based data on causes of morbidity and mortality, political or cultural barriers or facilitators, and/or more locally focused data about local needs, barriers or facilitators. ‘In these communities, infant mortality is high, and 40% of all deaths among children less than five years of age are due to diarrhea. In prior studies, households in these communities that added dilute bleach to their highly contaminated drinking water and stored it in vessels that prevented recontamination had markedly less contaminated water than households with standard water handling practices.’
Criterion #8 - Process of implementation: Description of facilitators or barriers which have influenced the intervention or program’s implementation (see #10) revealed by a process assessment. CReDECI, Mohler, also mentioned in Michie, [6, 7] In contrast to the criterion #7 above which assesses barriers and facilitators as inputs to developing the intervention strategy, this criterion assesses the actual barriers and facilitators identified during and after the implementation. ‘The reasons cited for non-compliance (multiple responses allowed) included: nobody was available to accompany the child (and the mother) to the health facility (24.7%); the child was given a traditional treatment instead (191%); bad weather or general strikes (17.9%); the family disliked hospital treatment (12.3%); symptoms resolved on their own (7.4%); unwillingness of the family or the TBA to refer the baby for other reasons (6.2%); and other issues (12.3%), such as illness of the mother; the child was too young to be taken for outside care; and lack of transport.
Substantial increases in referral compliance for newborn illness were likely related to (a) education of families on danger signs by the CHWs; (b) active surveillance for illness by the CHWs during routine postnatal home-visits; (c) facilitated referral by the CHWs, including counselling, use of referral slips along with improved linkages between community and hospital; (d) incentives for labour/birth notification; (e) enhanced capacity at the referral –care center to manage sick newborns; and (f) availability of subsidized treatment. Sustained community-level education enhanced the empowerment of families towards decision-making for self-referral.’
Criterion #9 - Description of materials: Description of all materials or tools used for the implementation CReDECI, Mohler, [6] This refers to printed materials, videos, pictures, syllabi, etc. used for training or implementation The research study references a five volume field training manual.
Criterion #10 - Process of Implementation: Description of an assessment of the implementation process CReDECI, Mohler [6] Process assessment is a prerequisite for determining the success of the intervention's implementation and should be an integral part of an assessment of the intervention’s effect. ‘To gain insight into the dissemination and the delivery of the intervention and to draw conclusions about potential barriers and facilitators to implementing the intervention in other settings, data on the implementation process were collected alongside the randomized-controlled trial. Therefore, we assessed the quality of delivery of the interventional components (observed by members of the research team not involved in the delivery of the intervention) and the adherence to study protocol (number and type of deviations from the protocol, using a pilot-tested standardized form). We also analyzed barriers and facilitators for the delivery of intervention’s components (focus group interviews with intervention participants).’