309J Contemp Med Sci | Vol. 5, No. 6, November–December 2019: 309–312 Original ISSN 2413-0516 Introduction The delivery of quality dental care is a key to the long-term success in oral health promotion. Improving the quality of health care services has been a key priority for successful gov- ernments.1 Clinical governance has so far become an import- ant aspect of quality assurance (QA) and it was first introduced in 1997 with the publication of the “New Labors first White paper on health” as a labor’s new approach in Public Health in the 21st century. The concerns were quality care being deliv- ered to the right patient at right time in a right manner.2 In relation to QA, there are several models available in public health. All models including: International Standardization Organization (9000, 9001-9004), Dental Excellence quality model of European Federation for Quality Management, total quality management, European Practice Assessment model, as well as the clinical governance3 are aiming at improving the quality of health care services. Clinical governance would build on (not replace) the existing patterns of QA.2 By defi- nition, clinical governance is “a framework through which dental practitioners are held responsible to improve quality of their services and establish high standards of care by cre- ating an environment in which excellence in clinical care will flourished.” This definition has been produced and applied by NHS clinical governance body, published by the Department of Health in 1997, for general dental practitioners.4 The clinical governance approach in UK was originally based on seven pillars (N.H.S approach) including: (1) Clinical effectiveness, (2) clinical audit, (3) risk management (RM), (4) patient safety, (5) patient and public involvement, (6) use of information, and (7) education and training.5 The clinical gov- ernance therefore, covers all activities that help maintaining and promoting patient care standards, and never negates other quality management systems.6 Background Compliant dental schools can train fully compliant graduates who can use principals and procedures of clinical governance in their daily clinical practice. The University of Texas Health Science Center, Dental Branch at Houston began credential- ing clinical faculty in 1997 as part of its QA and RM pro- gram. Credentialing is the process of obtaining, verifying, and assessing the qualifications of a health care practitioner who provides patient services in a health care organization.7 Hugh Bennet et al, developed a framework for evaluating clinical governance in dental field. This framework included clean- liness and infection control, safety and safeguarding, infor- mation and involvement, training and development, quality and improvements, and RM as main domains by focusing on reducing inequities in oral health.6 Holden and Moore devel- oped a 14 component model to define structure and process control in order to assure the expected outcome in overall clin- ical performance. They believe it is a robust, flexible, effective, and systematic way of improvements in QA.8 The “Medical Practitioners and Dentists board” in Kenya developed a national training and QA standards for dental schools and teaching hospitals including: governance and management, academic program, physical infrastructure, human resources, student affairs, program monitoring, and evaluation, as well Developing an innovative clinical governance assessment framework for dental schools in Iran Dehghanian D,a Heydarpoor P,b Namdari M,a Khoshnevisan MHc aCommunity Oral Health Department, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran. bSchool of Management and Medical Education Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. cPreventive Dentistry Research Center, Research Institute of Dental Sciences, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Correspondence to Khoshnevisan MH (mh.khoshnevisan@sbmu.ac.ir ) (Submitted: 07 July 2019 – Revised version received: 18 August 2019 – Accepted: 26 August 2019 – Published online: 26 December 2019) Objectives The aim of this study was to develop and validate a dental clinical governance (DCG) assessment framework for use in local dental schools in Iran. Methods A mixed method (qualitative and quantitative) was used in the present investigation. The study was performed in three steps, including: (a) thorough literature review, (b) focused group discussion, and (c) application of validated instrument. The content validity index (CVI) and content validity ratio (CVR) were calculated for each question. The Cronbach’s alpha coefficient was calculated to evaluate the internal consistency and reliability for this questionnaire. The Smart PLS software was used for calculation of goodness-of-fit (GOF) for confirmatory factorial analysis to determine construct validity of this questionnaire. Results Initially, 140 items covering 7 DCG domains were identified after comprehensive literature review. Ten specialists participated in the expert panel, rating independently on the necessity, relevancy, simplicity, and clarity of each question. Expert’s ratings were used to calculate the validity for each question. The questions with CVI lower than 0.79 and the CVR less than 0.62 were excluded. Reliability analysis was conducted by calculating intraclass coefficient and Cronbach’s alpha coefficient which were 0.88 and 0.92, respectively. This shows good reliability and internal consistency of the questionnaire. Construct validity determined by computing GOF index. The result was 0.622, which indicates a good level of construct validity. After validation process, 124 out of 140 questions left to cover the 7 domains of DCG in our newly developed and validated framework. Conclusions The newly developed and standardized DCG framework can be used for assessment of compliance level among Iranian dental schools at the national level. Key words dental clinical governance, dental schools, validation, questionnaire, framework 310 Original Developing an innovative clinical governance assessment framework Dehghanian et al. J Contemp Med Sci | Vol. 5, No. 6, November–December 2019: 309–312 as research and innovation.9 Fredekind et al performed a sur- vey to obtain information on whether dental schools inte- grated QA and RM and what mechanisms have been most effective in measuring accomplishments in those institutions. All 65 dental schools were sent a 29-item survey, of which 46 (71%) responded. Sixty-six percent of dental schools (n≈43) had a written QA program supervised by a QA committee.10 Kakudate et al evaluated the use of Japanese clinical guidelines among 148 dentists in a cross-sectional study. They concluded using clinical guidelines and evidence-based practice is still inadequate in Japanese dentistry, but use of the clinical prac- tice guidelines was significantly related to better clinical expe- rience.11 In current study, the aim was to develop and validate a dental clinical governance (DCG) assessment framework for use in local dental schools in Iran. Methods Using descriptive-analytic study design, the investigation was conducted in three steps, including: (a) thorough literature review, (b) semi-structured interview (focused group discus- sion), and (c) application of validated instrument in selected public dental schools. Please note that for the purpose of this publication steps 1 and 2 are presented and the rest will be reported separately. Step 1: Comprehensive Review of Literature A comprehensive review of literature was conducted by search in English electronic databases including: PubMed, Emerald, Science Direct, Google scholar, and also other published books and documents related to clinical governance to obtain different patterns and frameworks related to clinical gover- nance in dental practice in order to identify the main domains of Clinical Governance in dentistry. Step 2: Focused Group Discussion The outcome of the first step was formatted into a checklist containing 140 questions regarding clinical governance in dental practice prepared. The checklist was categorized in seven main areas. This checklist was provided to Focus Group participants 2 weeks prior to their meeting. A well-recog- nized expert (the head of the clinical governance committee at the ministry of health and medical education) was invited as a moderator to manage the focused group discussion. This professional committee was formed with 10 specialists whose qualifications are demonstrated in Table 1. The moderator’s goal was to generate the maximum amount of discussion and opinions provided by participants within a given time period.12 First, the moderator explained the importance of clinical gov- ernance in quality of health care services and described seven main components of clinical governance based on NHS sys- tem that has been applied for evaluating Iranian medical hos- pitals since 2009. Discussion on each question was continued and all opinions and comments were written in a board for further explorations and decisions. This cession was recorded and reviewed to make sure nothing was missed. Finally, spe- cialists were asked to provide comments independently on the necessity, relevancy, clarity, and simplicity of each question in order to calculate the content validity index (CVI) and content validity ratio (CVR) as well as other analytical procedures for standardization of the questionnaire. Results Reliability Two methods were used for internal consistency and reliability of the newly developed instrument: a) Cronbach’s alpha coefficient method was used to assess the internal consistency of a scale which relates to its homo- geneity. The calculated value was 0.92 that shows a good internal consistency between questionnaire items.14 b) Intraclass correlation coefficient (ICC) was calculated to determine the reliability of the scale using test–retest method. The test–retest reliability method was used to assess the stability over time, when applying the same test to the same subjects at different points of time.14 The esti- mate of ICC coefficient was calculated to determine the reliability of the scale using test–retest method. The ICC score was 0.88 that demonstrate good reproducibility of questionnaire. Content, Face and Construct Validity a) The expert panel’s rating on the necessity, relevancy, sim- plicity, and clarity of each question was used to calculate the validity for each question. According to Lawshe table, an acceptable CVR value for 10 expert panels was 0.62 and acceptable CVI was 0.79.13 Therefore, the questions with CVI lower than 0.79 and the CVR less than 0.62 were excluded. b) The face validity of the questionnaire was assessed by using the impact score (frequency × importance). The items related with an impact score of equal to or greater than 1.7 was considered appropriate. The mean score for CVI, CVR, and impact score were calculated for each domain and also for the whole questionnaire. c) Construct validity was assessed by confirmatory factorial analysis and computing convergent validity, discrimina- tive validity, and goodness-of-fit (GOF) index by comput- ing, R2, t-value, and communality indices. GOF index was 0.622, which indicates a good level of construct validity or good relationship between questionnaire items. The con- vergent validity was determined for each domain by com- puting average variance extracted (AVE). For each domain, Table 1. Qualifications of focus group participants # Specialty/Department Degree Academic rank Total 1 Social medicine PhD Assistant Professor 1 2 Endodontics MSc Professor 2 3 Oral and maxillofacial surgery MSc Assistant Professor 1 4 Operative dentistry MSc Associated Professor 1 5 Periodontics MSc Professor 1 6 Orthodontics MSc Professor 1 7 Dental public health PhD Associated Professor 2 8 Biostatistics and epidemiology PhD Assistant Professor 1 Total 10 311 Original Developing an innovative clinical governance assessment frameworkDehghanian et al. J Contemp Med Sci | Vol. 5, No. 6, November–December 2019: 309–312 AVE was higher than 0.5 which shows good convergent validity. Also, discriminative validity was computed for each question. The results showed that questions in each domain have more correlation with domain topic, com- pared to other domains. The components of validity and reliability analysis is demonstrated in Tables 2 and 3. After validation process, 124 out of 140 questions left to cover the 7 domains of DCG in our newly developed and validated framework. A total of seven questions on leadership and man- agement domain, four questions in clinical effectiveness and audit (prevention) domain, four questions in clinical effective- ness and audit (treatment) domain, and one question in RM domain were excluded because their scores were less than the acceptable thresholds. Fig. 1 shows the validation process. Components of final validated framework and number of questions left in each domain are shown in Table 4. It is important to note that the “clinical effectiveness and audit” domain is originally desig- nated for “treatment.” However, given the importance of “pre- vention” in dentistry, a separate domain was assigned for its robust independent assessment (numbers 3 and 4 in Table 4). Discussion Dental schools are under increased pressure to demonstrate QA efforts in their clinical practice. QA in any health care institution should meet the acceptable standards of patient safety with highest priority.10 However, the main goal of den- tal education is to: (a) fulfil the above requirement, (b) train competent dentists who are fully compliant with DCG, and (c) achieve oral health promotion in the public, without forgetting Table 2. Components of validity analysis Domains Construct validity (Confirmatory factorial analysis) Content validity Face validity R2 T-value Communality AVE CVR CVI Impact score Management and leadership 0.520 2.466 0.693 0.711 0.80 0.82 3.75 Clinical audit and effectiveness (prevention) 0.671 25.410 0.756 0.776 0.72 0.95 3.78 Clinical audit and effectiveness (treatment) 0.503 10.938 0.739 0.762 0.82 0.97 3.33 Patient and Public involvement 0.696 28.248 0.775 0.799 0.75 0.91 3.59 Risk management 0.403 9.490 0.603 0.624 0.84 0.95 4.15 Using information 0.417 9.152 0.821 0.850 0.91 0.87 3.34 Staff education 0.552 16.873 0.683 0.706 0.75 0.92 3.64 Mean 0.536 14.65 0.724 0.746 0.80 0.92 3.61 G.O.F GOF= R Communalityy ∗ = ∗ =0 536 0 724 0 622. . . Table 3. Components of reliability analysis Domains Reliability Composite reliability Cronbach’s Alpha Management and leadership 0.961 0.956 Clinical audit and effectiveness (prevention) 0.980 0.978 Clinical audit and effectiveness (treatment) 0.957 0.947 Patient and Public involvement 0.983 0.981 Risk management 0.981 0.980 Using information 0.992 0.992 Staff education 0.981 0.980 Mean 0.976 0.973 Table 4. Framework components and number of questions in each domain # Clinical Governance Domains Number of Questions 1 Management and leadership 10 2 Clinical effectiveness and audit (prevention) 15 3 Clinical effectiveness and audit (treatment) 8 4 Patient and public involvement 14 5 Risk management 32 6 Using information 23 7 Staff education 22 Total 124 Fig. 1 Framework validation process. 312 Original Developing an innovative clinical governance assessment framework Dehghanian et al. J Contemp Med Sci | Vol. 5, No. 6, November–December 2019: 309–312 the healthy individuals. Despite all scientific innovations and advancements, oral diseases are still highly prevalent based on epidemiological reports, as well as the ever-increas- ing socioeconomic and demographic changes that occur in most communities. The prevalence of dental caries among adults population is very high (over 95%) in most countries. Generally, oral diseases are considered as one of the major public health problems in all regions of the world. They involve individuals and communities and diminishing the quality of life by causing pain, infection, and sufferings that leads to impairment of function as well. Based on reported global bur- den of oral diseases, the condition is mostly concentrated in disadvantaged and poor communities. The current pattern of oral diseases are related to lifestyle and environmental factors, and lack of access to preventive oral health programs.15. The results of national survey regarding the oral health sta- tus in Iran (2018) showed that periodontal diseases and tooth loss are increasing compared with previous data. Caries-free status is sharply declining from 12 to 15 years olds (by 27%) and number of edentulous people is exceeding 50% in our elderly (65–74 years) population. These data indicate the urgent need for effective interventions in all age groups. Lack of support- ive oral health promotion policies for allocating appropriate resources was considered as the main reason for the current sit- uation in Iran.16 Therefore, development of new training stan- dards of care within the DCG framework is crucial to fulfil the population’s oral health promotion needs. On the other hand, future accreditation of dental school curriculum and the com- petencies of their graduates will receive reciprocal recognition at the local, regional, and global levels, if uniform standards of care is provided in harmony with DCG. DCG is dynamic and changing with advancement of science. Therefore, innovative dental schools will incorporate DCG framework in order to be qualified for certificate of compliance. This would also help to reduce high current demands for dental services by incorpo- rating preventive principals, while providing the high quality dental care to incoming patients. The newly developed frame- work has some similarities with Hugh Bennet’s framework that assessed fewer domains on patient’s satisfaction and patient’s complaints as an independent domain (patient and public involvement) can be considered as an advantage for this frame- work as well.6 Fredekind et al evaluated dental schools based on QA and RM domains10 while, the current validated question- naire focused on all seven domains of clinical governance for evaluating dental schools. The national training and QA stan- dards for dental schools and teaching hospitals developed by the “Medical Practitioners and Dentists board” in Kenya was rather considered as a comprehensive program with measur- able standards that can be comparable in some aspects with the newly developed framework, covering both QA and edu- cational needs of students in dental schools and teaching hos- pitals in Kenya.9 Kakudate et al evaluated the use of Japanese clinical guidelines which is related to clinical effectiveness domain11; while the current validated framework can assess all seven main domains of clinical governance in dental schools. The aim of this study was to develop an innovative frame- work for assessment of local dental schools in relation to DCG compliance level. The availability of such standardized framework can help all local dental schools to conduct vol- untary internal evaluation on their progress in meeting these standards. The Ministry of Health and Medical Education can also set the expected national standards of DCG and use this instrument for external evaluation of dental schools in order to ensure that those academic institutions meet the minimum requirements. To recognize such an important achievement, a compliance certificate may be issued by the Ministry of Health for qualified institutions. This document can play an import- ant role in accreditation of institution as well. Regular internal and external evaluations can safeguard QA in dental services delivery for all individuals, healthy, or otherwise. Conclusion The current study was conducted to develop a DCG frame- work for use in local Iranian dental schools. The newly devel- oped and validated framework can be used for assessment of compliance level among Iranian dental schools at the national level. References 1. Mills I, Batchelor P. Quality indicators: The rationale behind their use in NHS dentistry. Br Dent J 2011;312:11–15 2. Ball G. 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