Investigating the Effective Factors on Implementation of World Health Organization Package of Essential Non communicable Disease Interventions for Primary Health Care in Low Resource Settings: A Scoping review


 Background/objective:

Due to the widespread prevalence of non-communicable diseases, the World Health Organization has designed a package of essential interventions for non-communicable diseases for primary health care in low-resource settings. This study aimed to investigate the factors affecting the implementation of the WHO PEN for primary health care in low-resource settings.
Materials and Methods

This research was conducted through a five-step process of scoping review. We first searched for the keywords Noncommunicable Diseases, NCD, WHO PEN, PEN and other synonyms for these words to find the suitable analytical studies in databases including PubMed / MEDLINE, Scopus Cochrane Library, Web of Science, Google Scholar. The articles were then selected based on the PRISMA 2009 Flow Diagram. Finally, to analyze the content from the results section of the selected articles, we used the framework analysis method to extract the study implementation outcome and the factors affecting it.
Results

A total of 26 articles were included. Most articles are from 2016 to 2018. Most of the articles were cross-sectional and most studies evaluated the outcomes of Appropriateness and Feasibility. Identified effective factors include target population coverage, staff training, patient motivation, patient follow-up, and observance of PEN protocols.
Conclusion

Using this study, policymakers and managers of the health system will be able to implement this package (WHO PEN) more successfully.

We de ne the outcomes of implementation in the present study as the effect of conscious and purposeful actions to implement new treatments, procedures and services. Implementation outcomes have three important functions. First, they act as indicators of implementation success. Second, they are approximate indicators of implementation processes, and third, they are key intermediate results about the service system or clinical outcomes in the effectiveness of treatment and the quality of care research. Since without successful implementation, intervention or treatment will not be effective. , the outcomes of its implementation will be used as a prerequisite for achieving the desired changes in clinical or service outcomes (9).
Since limited and scattered research has been conducted both in terms of outcomes and in terms of the type of implementation of the study, as well as the factors in uencing the implementation of this package, and given the fact that the results of the science of implementation can improve routine health care in countries and communities with low resources, and the need for such results is certainly higher than in rich countries. In the present study, to achieve the predetermined goals of this WHO PEN program and to evaluate the implementation of its protocols, we intend to conduct a scoping review of the factors affecting the outcomes of implementation (Acceptability of the intervention, Adoption, Appropriateness, Cost, Feasibility, Fidelity, Penetration, Sustainability) of the Non-Communicable Diseases Intervention Package (WHO PEN) based on the conceptual framework expressed by Proctor et al (9) and identify and investigate the impact of interventions in the prevention of non-communicable diseases in setting with low resources.
One of the potential advantages of the scoping review is that it can provide an accurate and clear map of the areas of research (10). This study, in turn, makes it possible to identify gaps in the evidence base as well as to summarize and disseminate research ndings. By providing results in an accessible and concise format, policymakers, stakeholders, and users to make effective use of the ndings are in a better position.

Methods
In this study, using the ve-step process of Arksey and O'Malley framework for scoping review, we investigated and identi ed the factors in uencing the implementation of non-communicable disease intervention package for primary health care in settings with low resources (11). These steps include: identifying the research question, identifying the relevant studies, selecting the study, charting the data, and nally collecting, summarizing, and reporting the results. According to the framework of the scoping review used, our approach is similar to a narrative review that takes a broader view and Finally, the results are documented and is more comprehensible to readers.
In the rst step, the research question, which Investigated the factors affecting the implementation of the package of non-communicable diseases interventions for primary health care in environments with limited resources, was identi ed. In the second step, which is to identify the relevant studies, we rst searched for keywords Noncommunicable Diseases, NCD, WHO PEN, PEN and other synonyms for these words to nd suitable studies for analysis in databases including PubMed / MEDLINE, Scopus, Cochrane Library, Web of Science, Google Scholar.
In the third step, according to the inclusion criteria, including the structure of articles that have been evaluated based on the implementation of the Non-Communicable Diseases Intervention Package (WHO PEN) for primary health care, and the results achieved in each of the intended study implementation outcomes(Acceptability of the intervention, Adoption, Appropriateness, Cost, Feasibility, Fidelity, Penetration, Sustainability) between 2010, the time of the publication of the package (WHO PEN), until 2019, it was investigated and articles that did not meet the following criteria were excluded from the study: articles that were not in English, Articles that investigated other aspects of the package other than its implementation, articles that were not researched, articles that were not on a human subject. The researchers separately evaluated all related articles to classify studies according to inclusion criteria. Any discrepancies are discussed and a consensus was reached.
In the fourth step, the data of the selected articles were entered in the Excel database program. The content of data chart forms includes the following: author, year of publication, place of study, methodology, study objectives, important results that were identi ed and tabulated from selected articles. The data diagram was extracted to typology the articles using the Excel database software program. In the last step, according to the fth step, Arksey and O'Malley framework for scoping review, for content analysis from the results section of selected articles, We used the framework analysis method to derive the outcome of implementation of the intended study and the factors affecting it.
In this study, we used a conceptual framework proposed by Proctor et al to synthesize the results and to understand the implications of implementation outcomes (9). In this model, a variety of outcomes in implementation research including Acceptability of the intervention, Adoption, Appropriateness, Cost, Feasibility, Fidelity, Penetration, Sustainability are introduced. The Proctor Framework was identi ed as the most appropriate conceptual framework for guiding the overall design of our study, as it was speci cally developed to assess implementation activities in the eld of healthcare (12). As shown in Figure 1.

Results
A total of 408 articles were extracted. Search results were saved from each database in EndNote X9 and duplicate articles were removed, Finally, 354 articles remained. In the next step, by checking the titles and abstracts of the articles, they were screened based on the inclusion and exclusion criteria of the articles, as a result of which 318 articles were removed and 36 articles remained. In the last step, by reviewing the full text of the articles, 26 articles were found for the nal review. Figure 2 shows the steps for selecting articles based on the PRISMA 2009 Flow Diagram. After reading all the selected articles, the authors summarized the data of the selected articles based on Table 1. ( As Table1 larger than one Letter page in length is placed at the end of the document text le.) This program (WHO PEN) is designed for countries with a shortage of resources (LMIC). WHO member states are classi ed as low-and middle-income countries (LMICs) (6 WHO regions are used), and highincome countries divide each of these regions into a seventh group. Out of a total of 26 studies, one study is from 8 LMIC countries. Most of the studies are on Bhutan. A total of 18 single-country studies have been conducted. Most of the articles were published in 2016, 2017 and 2018. The most common type of article is among the 26 selected articles, cross-sectional survey articles with 9 articles and Commentary, perspective articles.
Based on the conceptual model of the present study, articles related to each of the factors affecting the implementation of the Non-Communicable Diseases Intervention Package (WHO PEN) for primary health care were identi ed and coded and categorized based on the outcomes of the implementation of the study (Acceptability of the intervention, Adaptation, Appropriateness, Cost, Feasibility, Fidelity, Penetration, Sustainability). Some studies, such as feasibility studies, have explicitly described and evaluated that aspect of the implementation factors that are feasibility. However, in some articles, by reading the full text and the questions and results obtained, based on the analysis of the framework, the desired outcome that the study sought to evaluate was extracted. Of the eight study outcomes, 6 outcomes were evaluated based on the articles, including Adaptation, Appropriateness, Cost, Feasibility, Fidelity, and Penetration, most of which evaluated the Appropriateness outcome. Finally, the factors affecting the implementation outcomes that were evaluated in each article were extracted and included in the subset of 4 categories include individual factors affecting the implementation of the program, factors related to the program, factors related to the organizational eld, factors related to the external eld. The classi cation of effective factors is based on the 4 categories mentioned in Table 2. The effective factors based on each of the outcomes of implementing the WHO PEN program are described below.

Adoption
Adoption refers to the proportion and representation of areas (such as worksites, health departments, or communities) that adopt a particular policy or program(34). Adoption is de ned as the goal, initial decision, or action to attempt or apply evidence-based innovation or action(35). Adaptation means "the process of creating a program to create as much as possible for a particular population or organization, based on its capacity.
Change in a program must be done without compromising or destroying the core components of the program" (36), is de ned. In this study, we outlined adaptation is one of the outcomes: In a study conducted to strengthen the relationship between health care and community services in Samoa, the word adaptation was used to assess the level of acceptance and coverage of the population. This program was covered(14) based on the de nition of Adaptation, it was decided to include this article as an article on the Adaptation aspect in the Adoption group. Factors in uencing the outcomes of adaptation include a focused community-based approach, monitoring the progress of intervention over time using data management, providing screening results to the community, and raising awareness of the nature of the early stages of NCDs.

Appropriateness
Appropriateness is the perceived t, relevance, or adaptability of innovation or evidence-based action to a set of activities, provider, or consumer, or understanding of innovation to address a particular issue or problem. "Appropriateness" is conceptually similar to "acceptance," and literature, when discussing these structures, shows overlapping and sometimes contradictory terms (9).
In this study, a total of 10 articles are related to this type of outcome. Examining these articles, the factors in uencing the outcome of "Appropriateness " include individual factors such as more accurate physical examination by a physician, more time with a physician, a better understanding of medication prescription, patient adherence to monthly visits to the intervention group due to advanced patient education, messaging SMS and components of telephone reminders, patient motivation, health education messages.
Organizational factors were such as availability of necessary equipment and medicines, referral systems, use of monitoring tools, training of rural health workers, lack of time, lack of staff, shorter waiting time, use of a time-setting system, no increase the follow-up period between visits, the importance of the division of labour, simple work ow, health information and research system, the existence of supportive technologies, Informed and supportive managers, recording basic demographic and clinical information, capacity building for health system research and training, better organization of testing Laboratory.
Program factors were identi ed such as patient follow-up, clinical trials, PEN Operations Manual, population coverage, accurate patient data recording, the changes measurement in population and not in patients, encouragement and follow-up of patients via mobile phones and Home visits, physician use of risk prediction charts and scores, training for newcomers, lifestyle counseling, intervention quality maintenance, target population coverage, opportunistic screening, evidence-based interventions, Complications monitoring, clear referral criteria and Participatory health care services, regular blood pressure measurements, Waist circumference and weight, Multilateral and frequent training, maintaining the quality of the intervention, regular approaches to identifying the target population and achieving coverage, engaging patients, the importance and priority of staff training to assess CVD risk, supporting the use of CVD risk charts as a communication tool, Expanding risk scoring on a larger scale, individual counseling, and the entire risk-based CVD algorithm.
External and environmental factors were identi ed such as budget allocation in annual programs, communication with local physicians, targeting public health myths in the community, barriers to access to patients such as distance and complex travel.

Cost
The cost of implementation is de ned as the cost of an executive effort. Implementation costs vary according to the three components. First, because the Treatments are very different in terms of their complexity, the cost of providing them will be different. Second, the cost of implementation will vary depending on the complexity of the speci c used implementation strategy. Finally, because the treatments are performed with different areas and complexities (from the individual physician's workplace to a third-level care centre), the overall cost of providing services in each area will vary. Therefore, the actual cost of implementing a treatment depends on the cost of the particular intervention, the strategy used, and the location of delivering services (9). In the present study, 3 articles have done an economic evaluation of the "WHO PEN" program. The results of two studies con rmed the cost-effectiveness of the WHO PEN program. In another study that was compared the program to another program in terms of cost-effectiveness, WHO PEN was less cost-effective. Factors in uencing the outcome of the "cost" identi ed in these studies include the justi cation of widespread and common treatment, the Utilization of a speci c population deprived of treatment, the prioritization of risk factors, the explicit and clear focus of guidelines on justice, signi cantly high population coverage under treatment, screening public health as a priority for the spread of screening, the prevalence of the disease, the falling rate of the relative risk of death from kidney disease, and The relative risk of death from controlled and uncontrolled blood pressure.

Feasibility
Feasibility means how can be successful a new treatment or innovation in an agency or a speci c location and using (37). In the present study, most of the articles based on WHO PEN Tool measured the capacity and readiness of health care centres to implement the program in ve areas including basic equipment, essential services, diagnostic capacity, counselling services and essential medications (2). Identi ed effective factors include the effectiveness of WHO PEN tools for ranking center performance, the effectiveness of WHO PEN tools to achieve NCD goals and prioritization, staff training, equipping centers, the availability of essential drugs, and the provision of quality services, Adequate training and skills in the use of some intervention technologies for early diagnosis and diagnosis, the existence of clear guidelines and policies to include promotion and prevention actions, the availability of basic equipment, basic diagnostic tests, medication and access to referral centers and medical records, Medical Information Management System, continuous and periodic monitoring of the capacity of centers during time, frequent monitoring and measurement of indicators of delivering medical services, the importance of scale up low cost and effective interventions, strengthening the capacity of health workers, access to basic technologies and essential drugs, training and empowerment of non-physician health workers, removing barriers to continued care By strengthening the medical information system, low quality of service due to lack of su cient nancing, the ability of family physicians to implement protocols and risk assessment, increasing people's awareness, screening, patient follow-up, free medication from nearby healthcare centers, regular consumption of Medications.

Fidelity
Fidelity is de ned as the extent to which an intervention is performed as intended in the original protocol or as intended by program developers(38). In this study, only one article was identi ed to evaluate this outcome. In this article, the observance of WHO PEN protocols by staff is measured by reviewing les in health centres.
The only effective factor is the degree of matching of data entry in the le, as well as the actions and followups performed by the staff according to the WHO PEN program protocols. Penetration "Penetration" is de ned as the integration of an action into a service setting and its subsystems (9). In this study, 3 articles evaluated this outcome of implementation. The most important factors identi ed in these articles include the commitment of the highest administrative authority, strong leadership of the Ministry of Health, integration of policymaking and services delivery, a coordination mechanism, cooperation of women representatives as community health workers, integration of national policies on NCDs in national health policy and development of a strategic action plan with national goals by global and regional voluntary goals, strengthening the multi-sectoral coordination mechanism, emphasizing the production of quali ed human resources for healthcare delivery focusing on the quantity, quality and categories required by the health workforce.  World health organization package of essential non-communicable disease interventions for primary health care in low resource settings (WHO PEN) to activate early diagnosis and management at the primary care level in low-resource settings. WHO PEN is a set of prioritized cost-effective interventions that can provide an acceptable quality of service at a low cost. These interventions have the minimum standards for non-communicable diseases, strengthening national capacity to integrate and expand care for heart disease, stroke, risk of cardiovascular disease, diabetes, cancer, asthma and chronic obstructive pulmonary disease in primary health care in low-resource settings (3). Therefore, in the present study, we tried to get a comprehensive view of the studies that evaluated the implementation of this package. In this regard, we used the conceptual framework of implementation of Proctor et al. Of the eight study outcomes, 6 were evaluated based on articles, including Adaptation, Appropriateness, Cost, Feasibility, Fidelity, and Penetration, and most of the articles were evaluated for Appropriateness. None of the studies evaluated the outcome of Acceptability and Sustainability.
Acceptability should be assessed based on the stakeholder's knowledge or direct experience with the various dimensions of the treatment to be performed, such as its content, complexity, or comfort. Acceptability differs from the broader structure of service satisfaction; satisfaction is typically measured through consumer surveys. Acceptability is more speci c, referring to a speci c treatment or set of treatments, while satisfaction typically refers to the experience of public services, including features such as waiting time, planning, and environmental conditions. Acceptability may be measured from the perspective of different stakeholders, such as supervisors, payers, providers, and consumers (9). Therefore, according to the framework used in this study, there is a lack of study in the eld of evaluating the acceptance or Acceptability of the program by the stakeholders of the program.

Conclusions
The results of this study show that there are few studies on the outcomes of the implementation of this program. Since evaluating the implementation of a program is considered one of the evidence of success in the implementation of that program, therefore, according to this study, research design is recommended in terms of the outcomes that were not studied. The study also identi ed and explained the factors in uencing the implementation of the program (WHO PEN) that facilitate the successful implementation of this program, or the obstacles to its implementation to support its successful implementation in Primary healthcare requires that they be removed. Therefore, according to the effective factors identi ed in this study, policymakers and managers of the health system will be more successful in implementing this package (WHO PEN   Process of selecting studies for scoping review

Supplementary Files
This is a list of supplementary les associated with this preprint. Click to download. PRISMA2009checklist1.pdf