This protocol will use the following: the PRISMA guidelines for reporting systematic reviews and meta-analysis protocol [
18], the methodological guidance of Arksey et al. [
19] and Levac et al. [
20] and for the final report of the results, the PRISMA extension for scoping reviews [
21].
Eligibility criteria
Type of studies: Process evaluation of randomized controlled trials (RCTs) and non-RCTs (feasibility studies, observational studies, quasi experimental studies). Given that process evaluations are often not explicitly labelled as such, we will include studies with the stated aim of understanding the functioning of an intervention to inform policy and practice and which evaluated at least one of the three areas (implementation, mechanisms of impact or context).
Participants: Patients with NCDs (type 2 diabetes mellitus, type 1 diabetes mellitus, cardiovascular disease, depression, chronic obstructive pulmonary disease and chronic kidney disease) [
22] and NTDs (Buruli ulcer, Chagas disease, dengue and chikungunya, dracunculiasis-guinea worm diseases, echinococcosis, foodborne trematodiases, human African trypanosomiasis-sleeping sickness, leishmaniasis, leprosy-Hansen’s diseases, lymphatic filariasis, onchocerciasis-river blindness, rabies, schistosomiasis, soil-transmitted helminthiases, taeniasis/cysticercosis, trachoma, yaws-endemic treponematoses, chromoblastomycosis and other deep mycoses, scabies and other ectoparasites and snakebite envenoming) [
23], and/or their health care providers (physicians, nurses, technicians, and others related to achieve better health).
Intervention: Complex interventions “interventions that comprise multiple interacting components, although additional dimensions of complexity include the difficulty of their implementation and the number of organizational levels they target” [
2]. The setting of the intervention considered will be at community, health system or policy level. These include community, primary health care and hospital level interventions, but also those related to reforms in universal coverage, public policy, service delivery and leadership.
Comparator: The control condition could be absent (e.g. pre-post evaluations) or may include treatment as usual, active control or placebo control. Also, studies with multiple active interventions will be included.
Timing: Published data from January 2008, this date was selected because in that year the Medical Research Council updated their guidance for developing and evaluating complex interventions [
2].
Setting: LMIC according to The World Bank in 2019, which included 31 low-income economies, 47 lower–middle-income economies and 60 upper–middle-income economies [
24].
Exclusion criteria: not a peer reviewed article, not a report based on empirical research, not reported in English or Spanish or Portuguese or French, reviews and not human research.
PubMed, EbscoHost, Web of Science (WOS), Virtual Health Library (VHL) regional Portal and Global Index Medicus: Regional Indexes AIM (AFRO), LILACS (AMRO/PAHO), IMEMR (EMRO), IMSEAR (SEARO), WPRIM (WPRO) Global Index Regional Indexes, MEDLINE, SciELO. A different search strategy will be designed for each database.
Study records
Data management
Covidence (Veritas Health Innovation Ltd), a Cochrane technology platform, will be used to the screening process. Citations will be imported from the databases, titles and abstracts will be screened, then manuscripts will be selected to proceed to data extraction.
Selection process
Two reviewers will independently consider the potential eligibility of each of the abstracts and titles that result from executing the search strategy. Reviewers will request the full text versions of all potentially eligible studies. Disagreements will be solved by a third reviewer.
Two reviewers working independently and blindly will consider the full text reports (all available versions of each study) for eligibility (Supplementary Material
2).
We will conduct a calibration exercise at the stage of titles and abstract screening. Meetings will be held to discuss the inclusion and exclusion criteria and later to contrast our decisions to include or exclude some articles to the next stage. During full-text screening, the all team will have two meetings to solve conflicts and then in pairs we will solve our conflicts together every 3 weeks. We did not consider a level of agreement to move forward, but the level of agreement will be reported.
Data collection process and data items
Data extraction will include (i) full description of study and the complex intervention, i.e. type of study, participants enrolled, the interventions they received, causal assumptions (hypothesis of how the intervention would work), setting, type of disease (NCD or NTD), specific framework and/or theory of the intervention (If YES, please specify which framework and/or theory), specific disease, main trial outcome (positive/negative/ equivalent). The following will also be explored (ii) details about the process evaluation if it is clearly labelled as a process evaluation, objective, pre-specified protocol, stage when the process evaluation was applied, specific framework and/or theory of the process evaluation (If YES, please specify which framework and/or theory, adaptations of framework and/or theory; and how the framework and/or theory of the Process Evaluation was used), method used, leading team of the evaluation (dependent or independent of the research team) and type of analysis (quantitative, qualitative, both); (iii) lessons learned about the process evaluation: strengthens and weaknesses of the design of the process evaluation and barriers and facilitators for implementation of complex interventions. The tools can be found in Supplementary Material
3, and these are a modified version of those used by Liu et al. [
3]. Additionally, how the information of the process evaluation was used will be collected (e.g. is the information of the process evaluation was used to inform future RCTs or future scale up at regional or national level or to improve the implementation programmes). Gaps detected by the process evaluation related to the implementation of the intervention (the difference between what was planned in theory and what was actually implement) will be identified, but also recognize when the intervention was implemented as planned.
The extraction format will be piloted by two researchers with 5 studies of different conditions (NCDs. NTDs) and different study types (RCTs and non-RCTs). Then, data will be extracted individually.
Evaluation
Aspects that will be evaluated are:
(1)
Available evidence in process evaluation in the areas of NCDs and NTDs like frameworks and theories
(2)
Methods applied to conduct process evaluations
(3)
The stated strengths and weakness of the process evaluation methodology from the perspectives of the authors and scoping review researchers.
(4)
Information on if the intervention was implemented as planned as well as gaps identified by the process evaluation between the design of the intervention and its implementation.
(5)
Findings from the process evaluations related to barriers and facilitators of implementation of the complex intervention.
This scoping review will use the Medical Research Council framework, and this will be used as the data extraction template as well as to report our results. Included studies will be compared with some parameters of the Medical Research Council Guidance: if the study was labelled as process evaluation; which type of methods were used; how many studies considered context, mechanism of action and implementation outcomes; and how many studies included theories or frameworks as well as report how they use its theories or frameworks (process evaluation was informed by theory, applied theory or tested theory) [
25].
The information will be synthesized through quantitative and qualitative analysis. Most variables will be extracted using codes, e.g. data related to the methods of the process evaluation and details of the intervention; whereas other variables like strengths and weakness, facilitators and barriers and how the information of the process evaluation was used will be literally extracted, and then codes will be generated to synthesize and organize the information.