Introduction: The immunosuppressive effect of the disease and the applied treatment in children with juvenile idiopathic arthritis increases the risk of infections. It is therefore essential that vaccinations be properly implemented and that a proper serological response is provoked after the vaccination. A competent nurse acting in compliance with the current recommendations constitutes one of the safety pillars of immunization of pediatric patients with juvenile idiopathic arthritis. Aim: To discuss evidence-based recommendations for immunization of pediatric patients with juvenile idiopathic arthritis in the context of nursing vaccination practice and vaccinology education. Material and Methods: A systematic review of the literature presenting evidence-based recommendations of the European League Against Rheumatism (EULAR) expert group on immunization of children with juvenile idiopathic arthritis. Compilation of source data selected subjectively by the authors in a standard literature search of Medline, Cochrane and Scopus databases, including both recommendations for immunization of children with juvenile idiopathic arthritis and the tasks to be performed by nurses in the course of vaccine administration. As part of the standard literature review of Medline, Cochrane and Scopus databases, including both recommendations for immunization of children with juvenile idiopathic arthritis and the tasks to be performed by nurses in the course of vaccine administration. Results: Most vaccines are immunogenic and safe for patients with juvenile idiopathic arthritis. The use of attenuated vaccines in patients receiving long-term immunosuppressive treatment should be considered with particular caution. Education and further training of nurses should take into account the recommendations and principles of immunization regarding children with juvenile idiopathic arthritis. Nurses should present the current knowledge of active immunoprophylaxis in such a way as to encourage parents/guardians to vaccinate their children in accordance with the national guidelines. Conclusion: The recommendations of the European League Against Rheumatism place special emphasis on the use of active immunoprophylaxis in the form of vaccination in children with juvenile idiopathic arthritis. The immunization schedule must be adjusted to the applied JIA treatment regimen. Such a stance on this matter is highly important as treatment regimens increasingly include biological drugs. Correctly performed by a nurse, a vaccination procedure is an important determinant of the desired immunoprophylactic results and minimizes the risk of adverse events following immunization. The priority for a nurse who provides active immunoprophylaxis should be to systematically broaden her training in immunization of chronically ill children, including juvenile idiopathic arthritis. Juvenile idiopathic arthritis (JIA), also known as juvenile rheumatoid arthritis, juvenile chronic arthritis or Still’s disease, is the most common form of arthritis in children. Its etiology is unknown. Generally, it has been indicated to have an autoimmune background . The JIAJIA is a chronic disease with periods of exacerbation and periods of remission. Pharmacological treatment involves aggressive combination therapy. As of date, disease-modifying drugs and immunosuppressive drugs are used. Biological therapy is a therapeutic alternative in patients with high disease activity in the absence of response to DMARD (mostly MTX). Both the immunological background and the therapy regimens may constitute important factors affecting active immunoprophylaxis in children with JIA ,2,5.Administration of vaccinations to healthy children, as well as to children with various chronic diseases, after medical examination and a pre-vaccination screening conducted by a doctor, is mainly performed by nurses. Awareness of the current recommendations for immunization of children with JIA is a key element of the proper implementation of the national immunization program (NIP). It also provides nurses with comprehensive knowledge, allowing them to talk constructively with parents/guardians and/or children about the administered vaccines ,7.The aim of this paper is to discuss the current recommendations of EULAR/PReS experts [EULAR (European League Against Rheumatism)/PReS , one adult rheumatologist/immunologist (M.D.), one expert in immunization (R.B.), one expert in public health and infectious disease control (F.vdK.), one epidemiologist (K.M.) and two physicians/Ph.D. students in charge of the systematic literature review .First, the expert committee defined the search terms for the systematic literature review, which was performed by searching the Medline database in December 2009, Medline and Embase in November 2010 and the abstracts from EULAR and American College of Rheumatology (ACR) meetings of 2008/9. Exclusion criteria were: non-rheumatic autoimmune diseases, malignancies, immunodeficiencies, transplantations, atopic diseases, animal studies, infections rather than vaccinations, vaccine development, phase I–III clinical trials, in vitro studies and non-English papers. Papers concerning the potential role of vaccinations in inducing rheumatic diseases were also excluded because the presented recommendations focus on the effect of vaccination on patients with pre-existing disease.The results of studies on adult patients with rheumatic diseases were extrapolated to juvenile patients. The results of the critical evaluation of the publications were debated, and subsequently, recommendations were formulated ,12,13,14The expert committee performed a critical evaluation of 60 articles on vaccinations and immunosuppressive drugs and 147 articles on vaccinations and autoimmune rheumatic diseases. Eventually, 107 articles and 8 abstracts were selected and used. They contained meta-analyses of randomized trials (Level IA), randomized trials (Level IB), prospective controlled interventional trials without randomization (Level II), observational studies, including case–control studies, cross-sectional studies and case series (Level III) and reports and opinions of expert groups and/or clinical experiments of respected authorities (Level IV). Most papers concerned vaccinations against seasonal influenza and pneumococcal infections. Twenty-six of the reviewed studies were conducted specifically in pediatric patients, and the remaining papers contained data on adults with rheumatoid arthritis or systemic lupus erythematosus. Fifteen recommendations were developed with an overall agreement from 7.9 to 9.8. Delphi voting method was applied to determine the level of agreement between the task force members. If the level of agreement was below 7.5, the recommendation was not incorporated in the guidelines. All studies concerned the efficacy of vaccination based on serological response. The analyzed scientific data were classified according to the quality of scientific content (Levels I–IV) and strength of recommendations (Grades A–D), where Grade A and B signify strong recommendations, evidence level I and II; and Grades C and D signify weak recommendations, evidence level III and IV. The overall agreement level among the members of the expert committee with regard to the recommendations was 91.7%. However, due to the lack of information on many vaccinations, diseases and immunosuppressive drugs, the strength of most recommendations is graded C or D.Thirteen out of 15 recommendations of the EULAR expert group for vaccination of children with rheumatic diseases are applicable to children with JIA. Among these, we can distinguish recommendations that address the administration of vaccinations with respect to immunosuppressive drugs  to occur more frequently than in the healthy population ,18,19. TAccording to the manufacturers’ recommendations, attenuated vaccines should not be administered to immunosuppressed patients due to the risk of infection by microorganisms contained in the vaccine preparation. For this reason, the EULAR expert group recommends delaying the administration of attenuated vaccines in patients receiving high-dose GCs, DMARDs or biological drugs until more data are available ,7,17,24.The MMR and VZV vaccinations are safe and effective for patients who are not on immunosuppressive drugs. Immunogenicity of MMR booster dose was confirmed as satisfactory in the studies conducted in children with JIA, irrespective of long-term methotrexate treatment .As of date, the safety of the tuberculosis vaccine (BCG) has not been studied in the population of children with JIA. At the same time, the risk of tuberculosis is increased in patients treated with immunosuppressive drugs, especially TNF-α antagonists . BCG vacAccording to the recommendations, administration of inactivated vaccines during therapy with low doses of GCs 2.5–40 mg/24 h), methotrexate (7–25 mg/week) or other DMARDs  or biological drugs appears to be safe. It is reasonable to refrain from administering attenuated vaccines, especially during the primary vaccination (first doses of the vaccine), in patients undergoing treatment with high-dose immunosuppressive or biological drugs. Usually, primary vaccinations (during infancy and early childhood) will have already been completed prior to the onset of the disease. However, there are no definitive contraindications for administering booster doses of attenuated vaccines ,40. mg/24 h,The effect of immunosuppressive drugs and the disease itself on the persistence of protective concentration of specific antibodies in the serum has still not been determined. In addition, further research is required to assess the administration of vaccinations in the context of the incidence of infectious diseases and their complications in the course of JIA ,6,7.In 2019, the EULAR expert group updated the guidelines for the use of vaccinations in autoimmune inflammatory rheumatic diseases in adults. Among six of their universal recommendations for vaccination in patients with rheumatic diseases, there are recommendations that deserve special attention as they are also applicable in children. These include a regular assessment (once a year) of the immunization level and indications for subsequent vaccinations. The assessment should be performed by a team of doctors working in a specialist rheumatological institution, which is taking care of the patient. In addition, this team shall also be responsible for discussing an individual vaccination plan with the patient and/or parent/guardian, enabling them to participate in making an informed decision. Vaccinations should be administered as a result of cooperation between a general practitioner and a rheumatologist, with the participation of the patient and/or parent/guardian and the vaccination nurse .Adequate implementation of immunization shall be a priority for the team responsible for the administration of vaccinations, especially in children with chronic diseases, including JIA. Any negligence in this area may result in the occurrence of VEs and their negative consequences for the patient ,43.In most countries, it is the nurses who are responsible for administering vaccinations. They administer vaccinations to healthy children as well as to children in special risk groups and children with diagnosed chronic diseases. It is the duty of the nurse who administers a vaccine to a patient with JIA to pay attention to several important issues during the implementation of vaccination procedure. She is obliged to carefully check the patient’s identity, confirm the type of vaccination to be administered with the patient and/or the parent/guardian, and ensure that their expectations are consistent with the indications for the vaccination. It is then important to inquire about any adverse events or exacerbation of the underlying disease that may have occurred after the last vaccination . It is aNext, it is necessary to check that there are no contraindications to vaccination. The nurse is obliged to carefully verify the written recommendations of the physician who qualified the patient for the vaccination. Vaccinations should be administered during remission of the underlying disease. The standard check also involves verification of the vaccine preparation . While administering a vaccination, it is important to follow the manufacturer’s recommendations and carefully choose the anatomical site and the technique of administration. Furthermore, the most effective method of soothing the pain that may accompany the vaccination should be recommended. Before administering a vaccination, it is important to ensure that the anatomical site recommended by the manufacturer can be used in a child with JIA . If this is the case, the nurse should consult the doctor and agree on an alternative injection site. It should also be noted that the proper technique of administration allows obtaining the desired immunoprophylactic results ,47.It is also vital that the vaccination nurse provide reliable information about potential adverse events that may follow immunization and maintain detailed vaccination documentation. After vaccination, the patient should remain under observation at the medical facility for at least 30 min. People cohabitating with a child who often undergoes immunosuppression should be encouraged to receive immunization in compliance with national guidelines in order to reduce the risk of exposing the child to infectious diseases .As part of her professional tasks in the field of health promotion and disease prevention, it is also the nurse’s duty to inform in an accessible way the child and the parent/guardian about the benefits and risks of vaccinations. Priority should be given to providing the patients with informational materials based on reliable scientific facts that can be trusted. The immunoprophylactic knowledge of nurses working in vaccination surgeries should, therefore, be regularly supplemented, in particular, by up-to-date data on vaccination options for children with chronic diseases ,49.Immunization in children with JIA is important and should be implemented. The immunization schedule needs to be adjusted to the child’s health status, the phase of the disease and the type of vaccination, with respect to the national immunization program. The recommendations of the EULAR expert group put particular emphasis on the use of active immunoprophylaxis in the form of vaccination in children with juvenile idiopathic arthritis. The immunization schedule must be adjusted to the applied JIA treatment regimen. Such a stance on this matter is highly important as treatment regimens increasingly include biological drugs.Vaccinations may be less effective in patients with JIA, but the safety profile is similar to that of healthy individuals. Correctly performed by a nurse, a vaccination procedure is an important determinant of the desired immunoprophylactic results and minimizes the risk of VAE.The course and severity of juvenile idiopathic arthritis constitute important factors in determining the immunization schedule;The recommendations formulated by the EULAR expert group address vaccination issues in children with juvenile idiopathic arthritis (JIA);A competent vaccination nurse has the necessary knowledge about vaccinations and contributes to their proper implementation in children with juvenile idiopathic arthritis.


Packaged water  has become an important element of water security in many low- and middle-income countries, owing to poor reliability and lack of piped water infrastructure. However, over time and across countries, the Demographic and Health Surveys monitoring program has inconsistently classified packaged water components as either improved or unimproved. Using data collected as part of the Performance Monitoring and Accountability 2020 (PMA2020) surveys on water options in nine study geographies across eight countries, we identified five geographies where packaged water constituted one of several options for 5% or more of users. In this study, four scenarios were designed in which packaged water components were variously classified as either improved or unimproved. Unimproved water use was highest in scenarios where sachet or refill water was classified as an unimproved source. Across the four scenarios, the difference in the use of unimproved water as the main option was highest (65%) in Nigeria (Lagos). That difference increased to 78% when considering all regular options. The development of these scenarios highlights the importance of classifying a source as improved or unimproved in the overall metric that indicates progress at national and international levels. Sachet water was not listed as an option, except in two countries - GH, where it was classified as an improved source and NG, where it was classified as an unimproved source. A summary of the DHS categorization of water sources is provided in Table S1 (available with the online version of this paper).Despite the change in DHS classification of bottled and sachet water, JMP has followed the 'backup-dependent' approach where bottled and sachet water are classified as improved or unimproved, depending on the nature of the backup source. However, the JMP's approach toward packaged water is likely to change as the global water monitoring shifts from the Millennium Development Goals (MDG) paradigm to the Sustainable Development Goals (SDG). Given the status of DHS as a premier international survey and its role in setting priorities for funding, interventions, and policy changes by its parent body and the world's leading government donor, USAID, modifications to the assessment of water sources by DHS is an important topic worthy of discussion.Classification of bottled water as an improved source, regardless of the backup source, along with ad hoc changes to the classification of sachet water introduces variability to the process of tracking water quality metrics. To highlight and quantify the variability in tracking water quality metrics introduced by technical changes to the classification of bottled and sachet water, we create four scenarios where packaged water components  are variously classified as improved or unimproved, and then observe changes to the population relying on improved water sources. Furthermore, we focus on one of the study geographies to identify factors associated with packaged water use.http://pma2020.org), a large-scale monitoring program led by Johns Hopkins University (JHU). PMA2020 surveys are modular in design, with a core set of questions repeated over time and across countries for easy comparison. Currently, PMA2020 surveys have a family planning and a water, sanitation and hygiene (WASH) module. Data and results presented in this article are derived from the drinking water section of the WASH module. The surveys were approved by the institutional review boards in each partner institution (listed in the Acknowledgments) and at JHU.We relied on data collected in nine study geographies across eight countries - Burkina Faso (BF), DR Congo , ET, GH, Indonesia (ID), Niger , NG , NG , and Uganda (UG) - by the PMA2020  for drinking purposes, PMA2020 interviews require respondents to indicate all sources used by the household on a regular basis for any part of the year for any purpose (regular option). Data on regular options provide insight into a household's decision-making on source-switch-ing when the main source is highly unreliable or unavailable for part of the year. Vedachalam et al.  used PMAde jure respondents wereincludedforanalysis,whichwas conducted using Stata v14.1  bottled water is regulated under stricter laws in several countries, (ii) multinational companies in the bottled industry may follow uniform sourcing and production checks, and (iii) higher pricing of bottled water compared to sachet/refill water allows the manufacturers to spend more on quality control.Worst-case scenario: Both bottled water and sachet/refill water are unimproved. This is the opposite of the ideal scenario, and assumes a poorly regulated packaged water industry, where the source water quality is not guaranteed, and the packaging and distribution is not monitored.ideal scenario, while that in NG follows the hybrid scenario. The backup-dependent scenario was employed by DHS in every country until 2008. The worst-case scenario is the only truly hypothetical scenario, but one which might be applicable in countries with poor bottling regulations and monitoring.DHS classification of packaged water in GH follows the Following development of the scenarios, we utilized household data from one of the selected study geographies to build binary logistic (logit) regression models to study the socio-economic and structural factors associated with packaged water use, both as the main option and as one of the regular options. The dependent variable in each of the models was the use of packaged water. Independent explanatory variables included socio-economic characteristics, structural factors, and a geographic regional control. Socio-economic variables included a dummy for urban location of the household, normalized wealth score, and household size. Structural factors included number of water sources, reliability of the main source for the non-packaged water users, or the reliability of the main alternative for packaged water users. Estimates are presented as odds ratios, with cluster-robust standard errors. Clustering is performed at the level of enumeration areas (EAs), which are clusters of about 200 households.In the nine PMA2020 study geographies, use of packaged water varied widely. Packaged water use as the main option ranged from 0.1% in ET to 65% in NGL . When coBased on these results, we selected geographies where packaged water constituted one of the regular options for at least 5% of the users. The selected geographies included CDK, GH, NGK, NGL, and ID. As observed from We next explored the relationships between the use of packaged water and socio-economic characteristics such as location and wealth. In the three study geographies that had both urban and rural samples, packaged water use as the main option was consistently higher in the urban sample . A localhybrid and worst-case scenarios, as compared to ideal and backup-dependent scenarios. The magnitude of difference between the two groups of scenarios was based on the fraction of respondents reliant on sachet/refill water as their main option. Estimates for unimproved water consumption as a regular option were similar in pattern, although not in magnitude, to those seen in Presented in We next focused on one of the study geographies, GH, to investigate the role of socio-economic factors in the use of packaged water. We already observed that packaged water use was higher in urban and wealthier households  and 4. HPackaged water use as the main option (panel A) was more likely to be observed in urban  and wealthier households  even after controlling for several other socio-economic variables. Smaller households  and access to multiple sources  were also associated with packaged water use. Reliability of the water source was associated with packaged water use in an unexpected manner. In comparison with an always-reliable main option, users with access to an intermittently predictable  source were less likely to use packaged water, while access to an unpredictable source as the main option was no different than having an always-reliable source. When all regular sources were included, drivers of packaged water use behavior (panel B) remained largely similar to those observed in panel A. Wealthy , and smaller  households and those with access to multiple water sources  were most likely to regularly rely on packaged water. Household location and source reliability, however, were no longer drivers of packaged water use.The popularity and widespread usage of packaged water in many LMICs may be attributed to convenience, safety, and attractive marketing of the product itself, or to the poor public infrastructure. In the PMA2020 survey of nine study geographies, packaged water consumption varied but constituted a regular source for more than 5% of the residents in five of those geographies. NGL's urban sampling frame could be a reason for the large packaged water use when compared to the nationally representative samples of GH and ID. However, NGL points to the outsize role packaged water often plays in an urban water landscape, where a highly mobile population can afford to pay for easy access to water, yet chronically suffers from lack of a reliable water service.PMA2020's inclusion of multiple water sources in its survey is a departure from other accepted global monitoring programs such as DHS and JMP that only assess the main source. As a result, estimating the regular use of packaged water is a better indicator of overall packaged water consumption than merely estimating its use as the main option. In every study geography, regular users of packaged water outnumbered the main users, in some cases by a significant amount.In study geographies that had both rural and urban sampling frames , urban consumption of packaged water was far higher than that in rural locations, suggesting packaged water use as, while not exclusively, a predominantly urban phenomenon. We also observed packaged water use was influenced by wealth. In all five study geographies, the proportion of packaged water users increased along with rising wealth, although there were differences in the profile of users along the wealth spectrum.backup-dependent scenario) is an alternative way to factor in the uncertainty associated with the quality of the packaged water source. Literature showing poor quality sachet water sold in NG and GH provides a plausible reason for such a cautious approach. After following the backup-dependent scenario for many years, DHS switched to a scenario that can, at best, be labeled ad hoc. While one may assume DHS was prompted to undertake this change based on evidence from the countries in question, there is no formal record of a country-level decision .The hypothetical classification of packaged water (or its components) as either improved or unimproved sources provided meaningful insights into the role of packaged water in the drinking water landscape in the selected geographies. The use of backup source to determine the nature of packaged water source  were closer to, but always lower than that under the backup-dependent scenario. As mentioned earlier in the Introduction section, even as DHS treats packaged water variously in different countries, JMP has consistently used the backup-dependent scenario for MDG reporting. However, JMP's treatment of packaged water will change to the ideal scenario under the SDG reporting , yields results that are similar to that under the worst-case scenario. This may be explained by the fact that bottled water is a much smaller component of the packaged water mix in all study geographies except CDK.DHS treats packaged water in GH under the Regression analysis of packaged water users in GH revealed that they are more urban and wealthier than users of other drinking water sources, even after controlling for other variables. This suggests that even as packaged water use has become popular in GH, it is mostly used by the wealthy and urban section of the population, leaving the rest of the country with poor, often unsafe alternatives. Smaller household size and access to multiple water sources also resulted in a higher likelihood of packaged water use. Location and source reliability were the only variables where regular users of packaged water differed from the main users. The counter-intuitive role played by reliability of the main water source in the 'main option' model and the lack of significance in the 'regular option' model suggests that users do not always rely on packaged water as an alternative to poor choices but rather to supplement existing reliable water sources. This finding may warrant further investigation as reliability may be closely correlated with other underlying factors that are not captured in our models.Packaged water use has increased in many LMICs where piped water availability is at best, unreliable and at worst, non-existent. Packaged water, but more so, sachet water, has filled the unmet need for an easy and accessible water source. The PMA2020 surveys identified high packaged water use in five study areas with NGL recording the highest use. Analysis of packaged water use in study geographies with both urban and rural samples portrays packaged water as primarily an urban and wealthy consumer product. Based on an analysis of Ghanaian respondents, this relationship held even after controlling for other socio-economic factors.Even though safety of any water source, including piped supply, is hard to guarantee without strict controls and a monitoring program, packaged water is especially ripe for contamination during production and distribution. A more comprehensive look at the role of sachet water in the larger water supply landscape suggests possible public health benefits. The mixed evidence points to the quandary of whether to place sachet water on the water ladder as an improved source or not. The development of four hypothetical scenarios played on this ambiguity, and demonstrated how classifying a certain source as improved or not plays a critical role in the overall metric that indicates progress at the national and international level.The decision of DHS to classify sachet water as improved in GH and unimproved in NG signifies the need for country-level decisions on progress indicators that better capture the quality of water infrastructure provided. At the same time, the DHS decision also suggests that moving sources from one category to another ad hoc can lead to a certain desired outcome. DHS and JMP metrics drive national and institutional donor policies; consequently, care must be taken to ensure that the metrics and classification schema reflect the needs of the people they are designed to help.Click here for additional data file.


The Kingdom of Saudi Arabia (KSA) has made tremendous improvements in its health care infrastructure in a short span of time . SocioecPrevious studies in the KSA have reported that many Saudi healthcare consumers frequently visit their local community pharmacy for multiple reasons, including disease-related advice, purchasing over-the-counter (OTC) or cosmetic products, and procuring prescription medicines for the treatment or prevention of the progression of chronic conditions , 3, 9–11The potential for community pharmacists to fill the capacity gap in providing extended patient-centered care services to patients in the KSA is a much-needed initiative , 14. GivNumerous studies conducted in the KSA agreed in principle about the “content” that means a change in the practice of the community pharmacy from its traditional role of providing only dispensing services to the consumers to the providers of patient-centered care , 16, 17.A qualitative research approach was used in this study to explore and understand stakeholders’ opinions on extended community pharmacy services in the KSA –21.A purposeful sample of stakeholders in pharmacy practice was selected to participate in the study. Prior knowledge of the education and health sectors of the KSA and recommendations from the study participants were used to identify potential stakeholders. The stakeholders comprised of participants who were either independent community pharmacy owners or chief operating officers of community pharmacies, academics, and researchers in pharmacy practice; high-ranking Ministry of Health officials; and people from professional pharmacy organizations in the KSA. An invitation was sent to twenty stakeholders based on the criteria mentioned above. Fifteen stakeholders agreed to participate in the interview. Those stakeholders include five officials from community pharmacies, one healthcare consultant, six officials from the Ministry of Health, and three academics and researchers in universities . On confirmation of a participant’s verbal and written consent to participate, the study information sheet and interview guide were emailed to them. All interviews were audio-recorded on a good-quality recording device. We applied the learning from one interview to go to the next interview to probe more accurately [Each stakeholder was contacted via email to identify if he/she would be interested in participating in the study. In some instances, individuals were contacted personally to participate in the study. All stakeholders were given an option for conducting interviews in English or Arabic. Twelve stakeholders preferred English, while three interviews were conducted in the Arabic language. For the Arabic interviews, a native speaker of the Arabic language, also fluent in English, accompanied the lead researcher curately , 22, 23.During the interview process, our main aim was to discover the interviewee’s framework of meanings, and the research task is to avoid imposing the researcher’s structures and assumptions on the interviewee’s account as far as possibl e, 23, 24.All audio recordings were transcribed verbatim, keeping the exact wordings. Once the transcription of all the interviews was completed, the lead researcher (MR) read it while listening to the recording and corrected any spelling or other errors. The transcripts were anonymized so that the participant cannot be identified from anything that is said  , 23, 25.Five central themes emerged from the data set Table  followedThe majority of participants agreed that the current community pharmacy practice in the KSA varies according to the type and location of the pharmacy. However, participants acknowledged that in KSA, pharmacists are primarily limited to selling and dispensing medicines. When one Ministry of Health official was asked about his opinion on the current practice of community pharmacy, he replied:They dispense the medication and just make sure the patient knows the medication and they just send the patient home and this is the current practice. OK, now, we have recently seen some new initiatives about pharmaceutical care, but still limited to some chain pharmacies. (MHO-2)A participant with an academic/research background depicted the current practice as more business-oriented than patient-centered:The most part of the community pharmacy practice is product oriented and sale oriented rather than actual pharmaceutical care practices or services in the community. (AR-2)However, participants belonging to the community pharmacies and some of the Ministry of Health officials gave a more optimistic look of the current practices:The present purpose of community pharmacies is to provide products of quantity and quality that serves the people and they are doing a great service. (MHO-1)The concept of community pharmacy is considered new in Saudi Arabia but when we talk about it in developed countries, it’s old and it’s applied from long time and practiced from long time, today new and upcoming regulations give more opportunities for patient-centered care facilities. (CP-2)According to the majority of the study participants, the current rules and regulations of MoH need to be updated to define more transparent practices of community pharmacies in providing patient-centered care. When one practicing academician and researcher was asked about the current standards of practice, he replied:I think the definition of the policy is the key here. We do have the general regulation of the practice of the pharmacy which includes to some extent the pure legal requirement of things like practice of community pharmacists, requirement of prescriptions for dispensing PoM (Prescription only Medications) etc. However, there needs to be more details about what a pharmacist can do, what kind of services and how they should provide them, title, level, details and depth of documentations and other details. We do have general rules and regulations but they are not detailed enough for the scope of practice. (AR-1)Contrary to that, when one of the high-ranking officials of the Ministry of Health was asked to give his opinion about the current laws regarding community pharmacy practice, he replied:The law is there and its clear, and everyone can understand the execution of it. It is based on people's understanding, and there is the understanding gap between the original body which is the Ministry of Health and the local health agencies . I know in the pharmacy, there is no regulation or policy of preventing or violating any pharmacies for opening any private patient-centered care services (MHO-6)The study participants expressed their opinion that the majority of the community pharmacists are mostly non-Saudis with different practice background and experience:Most of the pharmacists in the community pharmacies are expatriates and came from Middle Eastern or Asian countries and they bring the practice of community pharmacy in their country to Saudi Arabia. (AR-1)The participants also shared the opinion that the community pharmacists are not playing the role of providers of patient education effectively as illustrated in the following quotes:Most of the pharmacists in the community pharmacy, they have a limited knowledge, they do not have a clinical base. (CP-2)The type of community pharmacists that are right now existing, most of them are expatriates and with all due respect, they are very knowledgeable about the medications but they don’t have the skills to actually provide patient care. (AR-2)The stakeholders agreed that there is a dire need that community pharmacies play their role in imporving health outcomes in chronic conditions. Upon asking stakeholders what patient-centered care services would benefit Saudi health consumers, replies included:Saudi healthcare consumers need preventive services and public education about the chronic diseases, this includes lifestyle modifications to reduce the incidence of the chronic diseases like diabetes and hypertension. (AR-3)Pharmacy education reconciliation and counselling, these are the two main things that we need to have immediately as top priority followed by more specialized services like providing anti coagulation monitoring, provide HBA1c testing, asthma medication review and education through asthma clinics, antihypertensive education, hypertension management etc. (AR-1)They should be talking about contraceptives, talking about all the medications and its effect on the pregnancy. Minor illnesses care etc. (AR-2)The participants expressed their opinion that community pharmacies are easily accessible to healthcare consumers without the need for an appointment or wait in a long queue, as illustrated in the following:First we need to look why the healthcare consumers are preferring community pharmacies. The main reason is accessibility. Community pharmacies are more easily accessible to patients than primary health care centers. Patients avoid waiting for long period of appointments at hospitals, they don’t want to stay in queues in hospitals, long waiting time, shortage of physicians etc. (MHO-2)Some of the chain pharmacies in the KSA have initiated diabetic clinics, chronic disease management clinics, and immunization programs for the healthcare consumers with varying degree of success and patient acceptance as illustrated in the following quote by a study participant:We have been working on to help decrease the complications of the people with diabetes. Medical services provided by our diabetic center results in 20-40% decrease in complications, and the HbA1c which is recorded by our study team, decrease by 1.5%, which is significant. All of these interventions are done by the pharmacists, who didn’t change any medications, all they did was to educate the patients. (CP-1)Another participant expressed his opinion that despite free healthcare provided by the primary health care centers across the KSA, there is still a need for the patient-centered care initiatives from the community pharmacy:In my opinion, actually I prefer that government should start primary health care initiatives from community pharmacies. Pharmacies in hospital and primary care set-up have limited spaces, shortage of supplies, expiry issue and administrative issues. Private community pharmacies provide good solutions to all these problems. (MHO-2)The participants acknowledged that there are structural, administrative, and societal barriers facing the community pharmacies to attain the role of patient-centered care providers. The majority of the study participants expressed their concern that the scope and standards of patient-centered care services need to be strengthened:I think first one let’s say about regulations. It’s most important and Ministry of Health should have some kind of clear and transparent regulations, answering need of any owners so that it could be adopted by the owners of the community pharmacy. (HC)One of the issues highlighted by the pharmacy owner and chief operating officers is the lack of economic benefits. Also, there were financial constraints in providing the patient-centered care services as illustrated in the quote below:The private health sector has increased financial pressures, especially in terms of increasing expenses and in terms of wages and in terms of lack of profitability from agents and on the other hand, too much competition (CP-5)Another barrier raised by participants was the lack of automation and the lack of access to patient data for community pharmacists. One interviewee attributed this to the unavailability of access to the patient records from the Ministry of Health and inadequacy of software available:We are missing a lot of tools that could help us in chronic disease management or the services in general. If I told you for example, give me a software that could help us to monitor adverse drug events or drug-drug interactions, patient leaflets in Arabic. (CP-3)An issue highlighted by the participants was the unavailability of pharmacy technicians in community pharmacies to support the pharmacist in the administrative work. Hence, it increases the workload of pharmacists, resulting in insufficient time to spend with the patients.We have the pharmacists doing the technicians job, having the tray and taking out medications by himself and doing everything. (AR-2)The participants strongly emphasized the need for an improved public image of community pharmacists.The other barrier is that actually related to the public view of community pharmacy, still we did not promote community pharmacy as a health care institution that provide not only medicine but also provide access to accurate information about medicines. (AR-3)The participants acknowledged that if community pharmacists are encouraged to engage with health consumers, they can deliver patient-centered care services.If you told the pharmacist that they need to perform these services and if you give them the right tools, if you give them the right time and education towards a particular service, and if you monitor those people, if you give them the smart objectives and you monitor those smart objectives and you manage those schemes, you can get the desired results. (CP-2)The participants also acknowledged that the big groups of pharmacies and professional organizations such as the Saudi Patient Safety Centre conduct their training programs to provide basic and continuous professional training to their community pharmacists .For diabetes, pharmacists gets training from the diabetes educators, they got the training from governmental entities and they come to provide training. The pharmacists got the training from these government entities for weight management problems, acne and other skin problems, nutritional problems and of course they also have training about side effects of medications, interactions of the medications as well. (CP-2)The following quote from a policymaker illustrates that the movement to shift the community pharmacy practice from its traditional role to the providers of patient-centered care has started:I think there's a huge movement right now, towards community pharmacies, I know, these movements come from independent agencies not related to the field itself, like from universities, from research centers, these movements will provide for sure a huge impact in the future. What I'm seeing now, many community pharmacies are getting the idea that the current practice is not the right practice, this is not the ideal practice. So let's take it a step ahead and then provide patient-centered care practices. (MHO-6)The participants expressed that monitoring of therapeutic outcomes of the chronic diseases and promoting medication adherence can be the motivation to change practice change at community pharmacies.You know, when you transfer a discharged patient from hospital, you will lose them most of the time and nobody will follow up with. The patient will be on their own and nobody helps them. If you can have a community pharmacies bridge this gap and then the patients can see a community pharmacists going over their medication’s adherence at different or specific time periods, it’s going to be a huge, huge impact on healthcare consumers. (MHO-6)The participants acknowledged that providing patient-centered care services attracts more healthcare consumers, who appreciate and maintain their loyalty towards their local community pharmacy.There is tough and hard competition between the pharmacies these days, so the pharmacies have to provide clinical services free of cost to attract customers. (CP-1)The patient-centered care services affects the loyalty of the business, the people who use these services, they are usually very loyal to the branch and it affects the reputation of the company. (CP-2)Furthermore, participants indicated that to sustain the patient-centered care services in community pharmacies, appropriate incentives and reimbursement structures need to be in place.The pharmacist not going to spend half an hour or the 45 minutes of his time to discuss with the patients regarding certain medications or how to improve their control of the diabetes for instance, if he is not going to be reimbursed for that service. (AR-2)Saudi pharmacy graduates comprise only 4.2% of the total community pharmacies employment by the private sector . The parI think if Saudi pharmacist works as a community pharmacist, they will know my culture and also they can ask me question according to my situation. (MHO-3)The participants acknowledged that the Ministry of Health is updating the new regulations regarding patient-centered care services offered through community pharmacy.The current pharmacy regulations are being revised and hopefully will have more detail about the roles and practices of community pharmacists and different patient-centered care services that can be provided through community pharmacies. (AR-1)However, participants also showed concern that for any updated regulations, local health councils throughout the KSA need to be trained appropriately to enforce these regulations:If you have the legislation that has been created by a minister from the headquarter and at the time it will be released, all the ministry of health directorate need to be aware and trained of and about how we can inspect and also push for the service or even audit against these centers (CP-2)The majority of stakeholders agreed that the effective collaboration between the Ministry of Health, professional bodies like the Saudi Food and Drug Authority (SFDA) and Saudi Patient Safety Center (SPSC), Saudi Pharmaceutical Society (SPS), community pharmacy owners/CEOs, and Pharmacy Colleges and Research Institutions is necessary for the successful transition of community pharmacy practice in the KSA , 30, 31.The community pharmacy practice can be transformed to a more modern practice and to be successful I believe we need all stake holders in this aspect working together including community pharmacy private sector itself with the Ministry of Health and also with Saudi FDA. (AR-3)Collaboration is an excellent idea. But you need to again enforce it or have an independent agency like recently in Qassim, the Saudi community pharmacy association, this is an independent agency that can provide different training programs and then it should be certified by Saudi commission of health services and commissioned by a Ministry of Health to provide these training programs. (MHO-6)The study findings document that the patient-centered care is a new concept in community pharmacies of the KSA. However, the stakeholders in this study perceived that the knowledge and skills of community pharmacists are inadequate to provide patient-centered care services effectively. The study participants acknowledge that big community pharmacy groups in KSA do provide training in diabetes education and other patient-centered care programs in some of their selected community pharmacies . ContrarThe extracts of the interview showed that although the MoH regulations are clear regarding community pharmacy practice in the KSA, they need to be refined and updated to define the clear role of community pharmacists in providing patient-centered care services , 31. OneThe majority of the stakeholders acknowledged that to support healthcare in the KSA, community pharmacies need to offer specialized services like diabetes and hypertension education and monitoring, medication counseling, anticoagulation monitoring, asthma clinics, women health initiatives, and treatment of minor illnesses. The studies in the KSA showed that Saudi health care consumers appreciate community pharmacies providing patient-centered care and they prefer community pharmacies to primary health care centers and hospitals to discuss their medication and disease-related problems because of easy accessibility and flexible opening timings , 38, 39.The KSA is a high-income country and its healthcare sector is transforming with the rapid advancement of technology, research, and development , 2, 16. The majority of stakeholders in this study mentioned that the MoH policies and regulations should include more explicit role of community pharmacists and the type of services offered, and that can be the main driver of the change towards making community pharmacies as health care providers in the KSA. The participants also highlighted that any future change in policies should take into consideration the business and profitability of community pharmacies.The participants also identified several challenges of the successful transition of community pharmacies. The importance of an adequate pharmacy dispensing software in the Arabic language, linking of the patient data from primary health care centers and hospitals to the community pharmacies, and overburdening of administrative work are major technical and administrative barriers highlighted by stakeholders . A conceThe stakeholders agreed that professional pharmacy organizations, academics, and researchers can lead and influence the drive for future practice change in community pharmacies. Awareness of the change in the public and raising the competency of current pharmacists through professional development initiates are also important factors highlighted in the interview extracts.Although there was awareness among study participants about certain factors that can drive the change process, these were not necessary to motivate present and future pharmacy staff to become actively involved and start the change process. The excerpts from the study participant’s interviews suggest that pharmacists need professional satisfaction through incentives and rewards for their services . The parFacilitators identified from the interview extracts include remuneration, task delegation, leadership, reorganization, support from governmental entities, and collaboration. The stakeholders described that community pharmacy owners can increase the level of competency of their pharmacists by enrolling them in professional development and certification programs offered by different government entities, which are facilitating the process of change. In addition to supporting from government entities, the value of collaboration between professional bodies, academics, and community pharmacies was highlighted in the interviews through the sub-themes of effective leadership and task delegation. The extracts from the qualitative data suggest that even with appropriate training, collaboration, support, and remuneration, the sustainability of the change process in community pharmacy is at risk if community pharmacists do not move away from their traditional roles and activities to deliver patient-centered care services.There are some limitations associated with this study. For example, the investigators sought a variety of opinions from key stakeholders belonging to different organizations; the findings of this study may not reflect the views and experiences of all stakeholders. Another limitation of the study is that views from healthcare consumers were also not sought.The findings of this exploratory study describe the need for a change in practice in both chain and independent community pharmacies in the KSA. This study identified the drivers, motivators, and facilitators of the change of practice in community pharmacy towards patient-centered care. Defining broader roles of community pharmacists in the regulations set by the Ministry of Health and the utilization of trained pharmacy technicians to support the community pharmacists were identified as important drivers. The nationalization of the practice and incentives and rewards for providing patient-centered care is also considered to be important motivators for practice change in community pharmacy. This study also highlighted the importance of effective collaboration between community pharmacy owners or chief operating officers, professional pharmacy organizations, and pharmacy colleges for the successful implementation of the change process in community pharmacy practice in the KSA.The motivation of community pharmacists appears to be an important factor for the success of the change process. We hope that the qualitative data obtained in this study will form an essential component of any future investigations related to the community pharmacy practice using quantitative methods.


The objective of this study was to evaluate the association between overweight, obesity and the incidence of advanced dental caries in South Korean adults, using alternate measures. The participants included 376,077 people aged 20 years and older who had health examination at least one time between 2005 and 2008. This evaluation is based on a change of body mass index (BMI) category, for 10 years, using a nationally representative data resource available from the National Health Insurance System. Instead of using decayed, missing, and filled teeth (DMFT), the diagnostic codes which indicate dental caries, pulpal disease and visiting frequency at dental health professionals were used in this case. A multivariate adjusted Cox regression analysis was performed to examine the association between advanced dental caries and BMI. In addition to the BMI, a multivariate analysis of gender, age, lifestyle behaviors and systemic disease information was included. To this end, the hazard ratio (HR) and 95% confidence interval (CI) were calculated. Chiefly, it is noted that the overweight and obese people were more likely to develop advanced dental caries independent of the noted variables. The positive association between high BMI and incidence of advanced dental caries was more prominent in the population’s characteristic of people who were in a classification of the elderly and women. Among the health and lifecycle behaviors, smoking or not was found to be one of the factors affecting the results. The alternate method used in this study showed that being overweight and obesity had a direct association with the incidence of advanced dental caries in Korean adults. Dental caries is a multifactorial disease that affects most of the world’s population and is a detrimental factor to the preservation of an individual’s oral health for a lifetime. It is the primary cause of oral pain and tooth loss as noted in adults and children . AlthougNational, subnational, and multi-center studies have shown that obesity, as measured by body mass index (BMI), has increased in recent decades in many populations globally . The incThe incidence and placement of dental caries usually begins at the surface of the tooth. It affects enamel, dentin, and pulp. Its treatment and diagnosis are managed differently for each tooth depending on its severity. When caries is mild and confined to the tooth surface, the pulp is normal and restorative treatment can be used. However advanced caries can cause pulpitis or pulp necrosis, thus requiring root canal treatment. The incidence of dental caries can be classified in various ways. It is usually based on a review of clinical and radiological results. Advanced dental caries means lesion that there is a lesion that extends to or through the dentinoenamel junction without extending more than half the distance to the pulp. If caries progresses to this stage, most patients are considered to be symptomatic. The dentist will consider root canal treatment at that stage of dental decay –18. WhetThe purpose of this study was to investigate the significance and association between incidence of overweight, obesity and advanced dental caries requiring root canal treatment in Korean adults using diagnostic code and frequencies of visiting dental health professional. We also tried to evaluate the effect of lifecycle behavior such as drinking, smoking, and exercise habits on this association and data review.This study used data from the Korean National Health Insurance Service (KNHIS), a government-affiliated agency under the Korean Ministry of Health and Welfare that manages and supervises all medical activities and procedures for healthcare in Korea. The KNHIS contains notations on the eligibility, medical treatment, health examination, and medical care institution databases of all patients within that database who received care for the years reviewed. The original collection of data and the secondary analysis of data was also approved by the Institutional Review Board of the Seoul St. Mary’s Hospital, Catholic University of Korea (KC16EISI0332). Our research is based on the use and analysis of anonymized data owned by the KNHIS at a certain cost. Generally, the anonymized and de-identified information was used for analyses, and therefore informed consent was not required in that case. The original data is subject to deletion after the research is finished. The permits for this protocol and procedure are given in NHIS-2016-2-079. Using KNHIS data, we customized a sample size of 1,025,340 subjects selected by a systematic sampling method to generate a high level representative sample from the total Korean population existing in 2005 [In Korea, the National Health Insurance is mandated by law as applicable for all citizens since 1977, and the medical statement, medical history, and prescription details are established as a KNHIS database. This vast sample cohort database is provided to researchers to support academic research, to help establish national policies in health care, and ultimately to be a cornerstone for improving public health and the general advancement of patient welfare in this country. Most people included in KNHIS, pay a certain amount of income every month. In this case, some of the medical expenses are subsidized by the KNHIS. Therefore, all of the data is charged and recorded to the KNHIS when the medical expenses are noted to have occurred. In the dental field, these subsidies include extraction, periodontal treatment, root canal treatment, amalgam restoration, and glass ionomer restoration, and do not include restoration including composite resin, inlay, onlay, and the installation of a crown. Also, in the case of root canal treatment, there are criteria and conditions in which subsidy is supported for each treatment action, whereby root canal treatment is usually completed through 2 or 3 visits. Therefore, we can screen patients who have undergone root canal by using the methods we have used as noted above.We defined advanced dental caries requiring root canal treatment as a diagnostic code of K02 or K04 more than three times a year. In this case, the diagnostic code K02 includes all caries. If a patient visits more than three times a year, it was noted that the patient might have advanced dental caries or rampant caries. Our data is derived from KNHIS, which is based on medical bills paid through national health insurance. In Korea, dental treatments such as composite, inlay, and crown restorations are not supported by the National Health Insurance. Therefore, these treatments are not recorded in KNHIS's database. This means that, most cases recorded more than three times as K02 or K04 can be expected to be root canal treatment. In the case of code K04, it is seen as a diagnosis ranging from reversible pulpitis to apical cyst including pulp necrosis, apical periodontitis, and periapical abscess. Notably, three or more visits are usually considered to conduct root canal treatment. Most causes of these pulpal diseases requiring root canal treatment are seen to be due to advanced dental caries or trauma. Dental trauma refers to structural damage of a tooth. It is further classified as fracture, concussion, or dislocation of tooth or root mainly diagnosed as s025 or s032. Thus, it can be excluded in this study. The data were retrieved on sex, birthdate, and diagnostic codes. Additionally, it was noted that if these codes were billed more than 3 times a year, we defined this person as having advanced dental caries.2 (m2). The BMI was also categorized into underweight, normal (BMI < 23) and overweight (BMI ≥ 23) as was noted according to the categorization and recommendation of the Korean Society for the Study of Obesity [In additional to age and sex, the health examination revealed information on advanced dental caries and BMI. The BMI was calculated according to the formula: weight (kg) / height Obesity . As desc Obesity , the smoThe SAS software package version 9.3  was used for statistical analysis in this study. Additionally, a multivariate adjusted Cox regression analysis was conducted to examine the hazard ratio (HR) and 95% confidence interval (CI) for the association between advanced dental caries and BMI. To this end, the calculations were made adjusting for age, smoking status, alcohol consumption, and exercise. For each Cox regression analysis, a p-value for linear trend across categories was calculated by introducing the ordinal variable in the model. In this case, a p-value < 0.05 was considered statistically significant.The general characteristics of the study population and subgroups are summarized in In the selection of variables, we selected the available variables in KNHIS data that are expected to influence the change in BMI. In addition, lifecycle behaviors including smoking status, alcohol consumption status, and exercise were included in the study, and the analysis showed that smoking was considered to be a statistically significant factor in this case. The HR for advanced dental caries was stratified by BMI level and by the smoking status in age- and multivariable- adjusted models , Fig 2. This large population-based national cohort study showed that overweight and obese people were more likely to develop advanced dental caries, such as requiring root canal treatment independent of confounding variables in Korean adults. The positive association between overweight, obesity and advanced dental caries were estimated as being more prominent in elderly people over 65 years of age and in women. Among the health and lifecycle behaviors, smoking or not was found to be one of the factors affecting the results.The present observational analysis is meaningful in that it is the first study surveying large number of adults consistent with previous reports, which were performed mainly in children and adolescents ,22–24. FWe used the diagnostic code according to ICD-10 and visit frequency to define advanced dental caries in this study. Previous studies on dental caries and obesity have mainly used the number of teeth and DMFT index and are known to have some limitations . When usThe other distinctive feature of this study was the first description regarding such a positive association in the elderly. With increasing age, in most patient populations the number of teeth experiencing caries accumulates while the number of remaining teeth decreases due to various causes. The effect of caries on the number of teeth and DMFT index is gradually diluted. Therefore, an alternative method is needed to evaluate caries to provide strategies to increase helping patients keep their teeth during older ages. Our approach using diagnostics and frequency of visits can show possible relationship. Unlike changes in eating habits in young people due to changes in the social-economic environment, changes in eating habits in the elderly may be related to the reduction of muscles caused by aging, weakening of masticatory and the number of the individual’s residual teeth. This leads to changes in dietary habits that rely on high nutrition, high calorie and soft foods, and these foods are more cariogenic due to their high viscosity and long oral residence time. In a previous study about oral health of the elderly, it was found that the lower the number of teeth, the lower the BMI . Our stuThe greater influence in women may be due to early eruption and hormonal fluctuations as has been reported in previous studies ,27. EarlSmoking was also associated with an increase in advanced dental caries in the patients in our study. Although, the direct association between smoking and an increased incidence of dental caries remains controversial . HoweverHowever, this study has some noted limitations. First of all, the dietary habits and oral hygiene were not considered because only the evaluation of BMI and advanced dental caries were compared. The KNHIS database, based on our research, did not include information about dietary habits or oral hygiene, and for this reason we could not consider it. Second, there may be some blind spots in the new method using diagnostic code and frequencies of visit. For example, pulpal disease caused by cracks can be included as variable reasons for the root canal treatment, but were also not considered for this study. And patients who developed systemic disease might have more frequent contacts with the dental care system which might induce surveillance bias, and this was also not considered as a factor in this study. Our study has a limitation with BMI categorization. As in previous studies that reported the relationship between BMI and dental caries, the distinction between underweight and normal weight groups may be necessary to clarify the results . While tStreptococcus mutans, a causative type of bacteria for dental caries. In other words, frequent food intake plays a major role in the development or progression of dental caries, as well as in the progression of the development of obesity in all population demographics. Increases in obesity and dental caries due to increased consumption and frequency of drinking beverages and refined sugars have been found in many studies [p = 0.0045).In other previous studies ,37–39, i studies –42. Howe studies , our stuOur findings show that increased BMI affects the development of advanced dental caries in the elderly population above 65 years, especially women. Unlike previous studies using DMFT, this means that caries that require root canal treatment are more likely to occur, excluding missing teeth from past experiences. Due to the extension of life expectancy, it is essential in modern societies to consider growing elderly populations and their health problems, not only in Korea but also globally. Obesity is one of those concerns, so many studies are ongoing, and our research is in this context. Clinicians treating older patients should consider not only oral diseases, but also various systemic diseases. As our findings show that BMI and advanced dental caries increase in older women, associations with various causative factors and diseases are being published. If dentists learn these associations and care about them when they see a patient, they will be able to provide the patients with better care along with the treatment of oral disease.This study suggests an alternative method for evaluating dental caries as found in a review of cases seen in epidemiologic studies. This method can also be used to study the relationship between advanced dental caries and other medical conditions or treatments, which were included in the KNHIS database. The diagnosis according to ICD-10 and appropriate methodological modifications are thought to be applicable not only in Korea, but will be used also in other countries with large cohort data. For example, if the method is used in the National Wide Inpatient Sample (NIS) in the United States and the National Health Insurance Research Database (NHIRD) in Taiwan, there is a possibility that research in a wider variety of relevant and additional fields could be conducted. In addition, there is another large-scale cohort database, the National Health and Nutrition Survey, which contains information on dietary habits and oral hygiene that our study for lack of time did not review. In the future, if these two cohort data are combined, the research will expand our horizons of various dental diseases in the oral cavity, and their effect on a patient’s overall health, as well as the effect of dental caries in other health areas affecting a patient’s physiology.This study is a nationwide cohort study to clarify the relationship between advanced dental caries requiring root canal treatment and the incidence of associated patient status being overweight and obesity. Using a high representative KNHIS database and alternative method, it is noted that high BMI causes the incidence of advanced dental caries, which is more pronounced in women and older than 65 years. Considering the various lifecycle behaviors, smoking was seen to be a substantial factor which influenced the development of advanced dental caries.


Performing cancer research relies on substantial financial investment, and contributions in time and effort from patients. It is therefore important that this research has real life impacts which are properly evaluated. The optimal approach to cancer research impact evaluation is not clear. The aim of this study was to undertake a systematic review of review articles that describe approaches to impact assessment, and to identify examples of cancer research impact evaluation within these reviews.In total, 11 publication databases and the grey literature were searched to identify review articles addressing the topic of approaches to research impact assessment. Information was extracted on methods for data collection and analysis, impact categories and frameworks used for the purposes of evaluation. Empirical examples of impact assessments of cancer research were identified from these literature reviews. Approaches used in these examples were appraised, with a reflection on which methods would be suited to cancer research  impact evaluation going forward.In total, 40 literature reviews were identified. Important methods to collect and analyse data for impact assessments were surveys, interviews and documentary analysis. Key categories of impact spanning the reviews were summarised, and a list of frameworks commonly used for impact assessment was generated. The Payback Framework was most often described. Fourteen examples of impact evaluation for cancer research were identified. They ranged from those assessing the impact of a national, charity-funded portfolio of cancer research to the clinical practice impact of a single trial. A set of recommendations for approaching cancer research impact assessment was generated.Impact evaluation can demonstrate if and why conducting cancer research  is worthwhile. Using a mixed methods, multi-category assessment organised within a framework, will provide a robust evaluation, but the ability to perform this type of assessment may be constrained by time and resources. Whichever approach is used, easily measured, but inappropriate metrics should be avoided. Going forward, dissemination of the results of cancer research impact assessments will allow the cancer research community to learn how to conduct these evaluations.Supplementary information accompanies this paper at 10.1186/s12961-020-00658-x. Cancer research attracts substantial public funding globally. For example, the National Cancer Institute (NCI) in the United States of America (USA) had a 2020 budget of over $6 billion United States (US) dollars. In addition to public funds, there is also huge monetary investment from private pharmaceutical companies, as well as altruistic investment of time and effort to participate in cancer research from patients and their families. In the United Kingdom (UK), over 25,000 patients were recruited to cancer trials funded by one charity (Cancer Research UK (CRUK)) alone in 2018 , and desIn the current era of increasing austerity, there is a desire to ensure that the money and effort to conduct any type of research delivers tangible downstream benefits for society with minimal waste –6. TheseThe interest in evaluating research impact has been rising, partly driven by the actions of national bodies and governments. For example, in 2014, the UK government allocated its £2 billion annual research funding to higher education institutions, in part based on an assessment of the impact of research performed by each institution in an assessment exercise known as the Research Excellence Framework (REF). The proportion of funding dependent on impact assessment will increase from 20% in 2014, to 25% in 2021.Despite the clear rationale and contemporary interest in research impact evaluation, assessing the impact of research comes with challenges. First, there is no single definition of what research impact encompasses, with potential differences in the evaluation approach depending on the definition. Second, despite the recent surge of interest, knowledge of how best to perform assessments and the infrastructure for, and experience in doing so, are lagging , 8, 9. FThere is a lack of clarity on how to perform research impact evaluation, and this extends to cancer research. Although there is substantial interest from cancer funders and researchers , this inThe aim of this study was to explore approaches to research impact assessment, identify those approaches that have been used previously for cancer research, and to use this information to make recommendations for future evaluations. For the purposes of this study, cancer research included both basic science and applied research, research into any malignant disease, concerning paediatric or adult cancer, and studies spanning nursing, medical, public health elements of cancer research.i.Identify existing literature reviews that report approaches to research impact assessment and summarise these approaches.ii.Use these literature reviews to identify examples of cancer research impact evaluations, describe the approaches to evaluation used within these studies, and compare them to those described in the broader literature.The study objectives were to:This approach was taken because of the anticipated challenge of conducting a primary review of empirical examples of cancer research impact evaluation, and to allow a critique of empirical studies in the context of lessons learnt from the wider literature. A primary review would have been difficult because examples of cancer research impact evaluation, for example, the assessment of research impact on clinical guidelines , or clinA systematic search of the literature was performed to identify existing reviews of approaches to assess the impact of research. No restrictions were placed on the discipline, field, or scope  of research for this part of the study. In the second part of this study, the reference lists of the literature reviews identified were searched to find empirical examples of the evaluation of the impact of cancer research specifically.For the first part of the study, 11 publication databases and the grey literature from January 1998 to May 2019 were searched. The electronic databases were Medline, Embase, Health Management and Policy Database, Education Resources Information Centre, Cochrane, Cumulative Index of Nursing and Allied Health Literature, Applied Social Sciences Index and Abstract, Social Services Abstracts, Sociological Abstracts, Health Business Elite and Emerald. The search strategy specified that article titles must contain the word “impact”, as well as a second term indicating that the article described the evaluation of impact, such as “model” or “measurement” or “method”. Additional file Following an initial title screen, 800 abstracts were reviewed and 140 selected for full review. Articles were kept for final inclusion in the study by assessing each article against specific inclusion criteria  by the primary researcher to identify empirical examples of assessment of the impact of cancer research. Summary tables and diagrams from the reviews were also searched using the words “cancer” and “oncology” to identify relevant articles that may have been missed by reference list searching. After removal of duplicates, 57 full articles were read and assessed against inclusion criteria  used. Information on approaches to impact assessment was extracted under three specific themes which had been identified from a prior scoping review as important factors when planning and conducting research impact evaluation. These themes were: (i) categorisation of impact into different types depending on who or what is affected by the research , and how they are affected  (ii) methods of data collection and analysis for the purposes of evaluation, and (iii) frameworks to organise and communicate research impact. There was space to document any other key findings the researcher deemed important. After data extraction, lists of commonly described categories, methods of data collection and analysis, and frameworks were compiled. These lists were tabulated or presented graphically and narrative analysis was used to describe and discuss the approaches listed.A data extraction form produced in Microsoft® Excel 2016 was used. Basic information on each study was collected, such as year of publication, location of primary authors, research discipline, aims of evaluation as described by the authors and research type under assessment. Data was also extracted from these empirical examples using the same three themes as outlined above, and the approaches used in these studies were compared to those identified from the literature reviews. Finally, a set of recommendations for future evaluations of cancer research impact were developed by identifying the strengths of the empirical examples and using the lists generated from the first part of the study to identify improvements that could be made.For the second part of the study, a separate data extraction form produced in MicrosoftForty literature reviews met the pre-specified inclusion criteria and the characteristics of each review are outlined in Table Approximately half of the reviews  described approaches to evaluate research impact without focusing on a specific discipline and nearly the same amount  focused on evaluating the impact of health or biomedical research. Two reviews looked at approaches to impact evaluation for environmental research and one focused on social sciences and humanities research. Finally, two reviews provided a critique of impact evaluation methods used by different countries at a national level , 23. NonTwenty-five reviews  specified search criteria and 11 of these included a PRISMA diagram. The articles that did not outline a search strategy were often expert reviews of the approaches to impact assessment methods and the authors stated they had chosen the articles included based on their prior knowledge of the topic. Most reviews were found by searching traditional publication databases, however seven  were found from the grey literature. These included four reports written by an independent, not-for-profit research institution (Research and Development (RAND) Europe) –26, one i.Categorisation of impact for the purpose of impact assessmentNine reviews attempted to categorise the type of research impact being assessed according to who or what is affected by research, and how they are affected. In Fig. The first two categories of impact refer to the immediate knowledge produced from research and the contribution research makes to driving innovation and building capacity for future activities within research institutions. The former is often referred to as the academic impact of research. The academic impact of cancer research may include the knowledge gained from conducting experiments or performing clinical trials that is subsequently disseminated via journal publications. The latter may refer to securing future funding for cancer research, providing knowledge that allows development of later phase clinical trials or training cancer researchers of the future.The third category identified was the impact of research on policy. Three of the review articles included in this overview specifically focused policy impact evaluation –32. In tImpact on health was the next category identified and several of the reviews differentiated health sector impact from impact on health gains. For cancer research, both types of health impact will be important given that it is a health condition which is a major burden for healthcare systems and the patients they treat. Economic impact of research was the fifth category. For cancer research, there is likely to be close overlap between healthcare system and economic impacts because of the high cost of cancer care for healthcare services globally.In their 2004 article, Buxton et al.  searchedThe final category was social impact. This term was commonly used in a specific sense to refer to research improving human rights, well-being, employment, education and social inclusion , 37. Twoii.Methods for data collection and analysisIn total, 36 (90%) reviews discussed methods to collect or analyse the data required to conduct an impact evaluation. The common methods described, and the  strengths and weaknesses of each approach, are shown in Additional file Several reviews explained that the methods for data collection and analysis chosen for impact evaluation depended on both the unit of research under analysis and the rationale for the impact analysis , 50, 51.iii.Using a framework within a research impact evaluationApplied to research impact evaluation, a framework provides a way of organising collected data, which encourages a more objective and structured evaluation than would be possible with an ad hoc analysis. In total, 27 (68%) reviews discussed the use of a framework in this context. Additional file The challenges of research impact evaluation were commonly discussed in these reviews. Several mentioned that the time lag , 53, 55 In total, 14 empirical impact evaluations relevant to cancer research were identified from the references lists of the literature reviews included in the first part of this study. These empirical studies were published between 1994–2015 by primary authors located in the UK , USA , Italy , Canada  and Brazil . Table i.Categories of impact evaluated in cancer research impact assessmentsSeveral of the empirical studies focused on academic impact. For example, Ugolini and colleagues evaluated scholarly outputs from one cancer research centre in Italy  and in aThe category of the health impact was also commonly evaluated, with particular focus on the assessment of survival gains. Life years gained or deaths averted , life exFinally, two studies , 69 perfii.Methods of data collection and analysis for cancer research impact evaluationMethods for data collection and analysis used in these studies aligned with the categories of impact assessed. For example, studies assessing academic impact used traditional bibliometric searching of publication databases and associated metrics. Ugolini et al.  applied Lewison and colleagues, who performed four of the studies identified –63, usedTo assess policy impact these authors extracted journal publications from cancer clinical guidelines and for media impact they looked at publications cited in articles stored within an online repository from a well-known UK media organisation (British Broadcasting Co-operation). Interestingly, most of the cancer research publications contained in guidelines and cited in the UK media were clinical studies whereas a much higher proportion published by UK cancer centres were basic science studies. These authors also identified that funders of cancer research played an critical role as commentators to explain the importance of the research in the lay media. The top ten most frequent commentators (commenting on > 19 media articles (out of 725) were all representatives from the UK charity CRUK.A combination of clinical trial findings and documentary analysis of large data repositories were used to estimate health system or health impact. In their study, Montague and Valentim  cited thThe methods of data collection and analysis used for economic evaluations aligned with the categories of assessment identified by Buxton in their 2004 literature review . For exaThe second of Buxton’s categories was an estimation of productivity loss using the human capital approach. In this method, the economic value of survival gains from cancer research are calculated by measuring the monetary contribution from patients surviving longer who are of working age. This approach was used in two studies , 66 and The cost estimates used in these impact evaluations came from documentary analysis, clinical trial publications, real-life data repositories, surveys, and population average income estimates. For example, in one study, cost information from NCI trials was supplemented by using a telephone phone survey to pharmacies, historical Medicare documents and estimates of the average income from the 1986 US Bureau of the Census Consumer Income . In theiLastly, the two studies , 69 whiciii.Frameworks for cancer research impact evaluationOnly two of the empirical studies identified used an impact framework. Unsurprisingly, these were also the studies that performed a multi-category assessment and used the broadest range of methods within their analyses. Donovan et al.  used theLastly, the challenges of time lags and attribution of impact were identified and addressed by several of these empirical studies. Lewison and colleagues tracked the citation of over 3000 cancer publications in UK cancer clinical guidelines over time , and in This study has identified several examples of the evaluation of the impact of cancer research. These evaluations  were performed over three decades, and mostly assessed research performed in high-income countries. Justification for the approach to searching the literature used  in this study is given by looking at the titles of the articles identified. In only 14% (2/14) was the word “impact” included, suggesting that performing a search for empirical examples of cancer research impact evaluation using traditional publication databases would have been challenging. Furthermore, all the studies identified were included within reviews of approaches to research impact evaluation, which negated the subjective decision of whether the studies complied with a particular definition of research impact.Characteristics of research that were specifically relevant to cancer studies can be identified from these impact assessments. Firstly, many of these evaluations acknowledged the contribution of both basic and applied studies to the body of cancer research, and several studies categorised research publications based on this distinction. Second, the strong focus on health impact and the expectation that cancer research will improve health was not surprising. The focus on survival in particular, especially in economic studies looking at the value of health gains, reflects the high mortality of cancer as a disease entity. This contrasts with similar evaluations of musculoskeletal or mental health research, which have focused on improvements in morbidity , 74. ThiThere were limitations in the approaches to impact evaluation used in these studies which were recognised by reflecting on the findings from the broader literature. Several studies assessed academic impact in isolation, and studies using the journal impact factor or the location of authors on publications were limited in the information they provided. In particular, using the journal impact factor (JIF) to allocate funding research which was used in one study, is now outdated and controversial. The policy impact of cancer research was commonly evaluated by using clinical practice guidelines, but other policy types that could be used in impact assessment , such asReflecting on how the methods of data collection and analysis used in these studies aligned with those listed in Additional file Lastly, despite the large number of examples identified from the previous literature, a minority of the empirical assessments used an impact framework. The Payback Framework, and an iteration of the CAHS Framework were used with success and these studies are excellent examples of how frameworks can be used for cancer research impact evaluation in future. Other frameworks identified from the literature  and Table S2 .