National health guidelines in I.R of iran, an innovative approach for developing countries.

BACKGROUND: Guidelines have produced and used in complex environment of health care system with its ethical, economical, legal and other aspects; that should be taken into account in any country. Modifying the format and content of guidelines might facilitate their usage and lead to improved quality of care and cost containment. We have produced this tool for explained above purpose.
METHODS: A coordinating national team has settled at the office of minster of health and medical education, supported by a guideline review committee. An innovative and appropriate approach for adapting national health guidelines has consisted of eight steps, have defined For preparing the draft of each guideline a technical team which, including main author, her/his co-workers have nominated. The authors of each topic have systematically searched databases of the proposed Twenty-two International Sites, and then have selected at least five sources of them that were more relevant. The final recommendations have proposed by agreement of technical team and Guideline Review Committee.
RESULTS: In less than 5 months, more than 500 authors in whole country have selected to prepare guidelines and, approximately 150 guidelines have provided in three volumes of the published and distributed book. Each guideline had a national ID number, constant forever; all topics should be reviewed every 3-5 years.
CONCLUSION: National health guideline(s) would be essential means for policy making in health system and increased the cost containment and quality of care. Ministry of Health and Medical Education should provide and distribute the guidelines based on its accountability to legal responsibility.

Introduction

Guidelines would be the syntheses of the best available evidences, in addition to professional judgment and patient preferences, support decision-making by clinicians, managers and policy makers about the organization, delivery and improvement of health care [1-8]. According to the World Health Organization’s (WHO) definition, appropriately developed guidelines, based on the best available evidences, should assist providers and recipients of health care and other shareholders to make informed decisions. Recommendations [in guidelines] might relate to clinical interventions, public health activities, or government policies [9-11]. The first clinical guideline have produced by the UK’s National Institute for Clinical Excellence was on schizophrenia, in Australia date to the late 1970s, when the state health authority began endorsing guideline booklets [12, 13]. Most of the guidelines have established in high-income countries but progress in developing such national programs in low and middle income countries has still been lagging behind [14]. They have sought for improving the quality of care provided to the patients, reducing variability and containing the health care costs [15, 16].

The development and updating of high- quality practice guidelines have required substantial resources. Most organizations were under pressure to produce more guidelines in a shorter time with increasingly limited resources [17]. Achieving those goals was difficult, and despite the development of clinical guidelines in many countries, solving the problems of cost and quality as well as variation in care has remained a challenge to health systems [18]. The WHO has recognized the need to use more rigorous processes to ensure that health care recommendations have informed by the best available research evidence [19]. Guideline adaptation has defined as the ‘systematic approach to considering the use and/or modification of guideline(s) produced in one cultural and organizational setting for application in a different context [20]. Customizing evidence-informed guideline recommendations for local application has demanded both methodological expertise and an intimate knowledge of the intended clinical practice environment. Dedicated guideline development bodies might have greater capacity to synthesize evidence but often had limited access to detailed contextual information. However, the cultural and organizational differences between and within countries could lead to legitimate variation in recommendations, even when the evidence base would be the same. The means that guidelines produced in one setting might not necessarily be appropriate for another, without careful consideration and/or contextualization [21]. Guidelines have produced and used in the complex environment of a health care system with its cultural, ethical, economical, legal and other aspects ; these aspects have need to be taken into consideration in each country [22]. Guidance has needed to be transparent, systematic, and adapted to the local contexts [23]. The first National programs of guideline development have started in the USA in the 1980s. National programs have also sought with the expectation that it will be easier and more fruitful to implement national guidelines than local or society developed clinical guidelines [24]. Transparent, cost-conscious and patient-centered guidelines based on the best available evidence could help establishing these quality and practice measures. Thus, use of guidelines might be optimized by improving their format and content [9]. Research has shown that guideline format and content influence perceptions about and use of guidelines specifically, these intrinsic guideline qualities have shown to promote greater understanding of how users could apply the recommendations, stimulating confidence in users, ability to practice the recommended behavior, leading to greater intent to use guidelines and actual use [13, 25-27]. In Iran, the authorities already have thought of producing and localizing the knowledge products such as clinical evidence-based practice guidelines [28]. In addition to legislation, a number of clinical guidelines have also produced and localized [29]. Legislator would be responsible for policymaking, planning and supervising on social, economic, cultural and politic, register and presentation of policies, strategies and activities related to training of employees for medical groups, research, health, treatment and medical services, welfare organization social security organization have defined as Ministry of Health and Medical Education (MOHME) responsibility and the Islamic Consultative Assembly in article number 36 (section B) in fifth 5 years development plan, ratified in January 5, 2011, Policy making, planning and supervision of health sector is the responsibility of MOHME and consider it as national priority of Islamic Republic of Iran. MOHME has recognized as policy maker and supreme supervisor of national health based on the article number 38 (section h), which all of the governmental and nongovernmental sectors in health areas should follow and obey its rules and regulations [30].

Despite the development of guidelines in many countries, the cultural and organizational differences between countries, the problems of cost and quality and limited resources, most organizations would be under pressure to produce guidelines. Guidelines that have produced in one setting might not necessarily would be appropriate for another, Our national works have conducted within the context of international and national guidelines in developed countries, which has aimed to harmonize guideline development methods in order to reduce duplication of efforts and to ensure efficient use of resources and produced national health guideline in Islamic Republic of Iran. For improving the quality of care provided to the patients, reducing variability and containing the health care costs, MOHME should provide and distribute the guidelines base on its accountability to legal responsibility.

Materials and Methods

The development of guideline recommendations in a typical professional society setting has occurred at committee meetings, under the direction of a chairperson. Guideline developers have divided in to 2 groups (include core and main group).

The principal aims of the core group were as below:

Coordinate and provide technical support on guidelines development,

Organize training on guideline production for main group,

Provide administrative support for the work of the Guidelines Review Committee. Collaborate with other organizations and international networks that provided methodological expertise in relation to guideline development, adaptation and implementation.

In addition, for each guideline a technical team which contains of author of guideline and co-workers have designated, who have competency in scientific and literary editing considering cost effectiveness as well as efficacy and equity. The team has included medical specialists in their respective fields, Statistician, public health practitioner and epidemiologist as methodologist. In order to adjust and conform, the authors of the guidelines, systematically searched databases of Twenty-two International Sites which have specifically supported by governments as shown in" table1"with the related keywords to the special subject(s).

Table 1

Website of Institutions accredited and governance

Title	Address
1) Agency for Healthcare Research and Quality's (AHRQ)	http://www.ahrq.gov
2) National Institute for Health and Care Excellence (NICE)	www.nice.org.uk
3) Swedish council on Health Technology Assessment in Health care	www.sbu.se
4) Scottish Intercollegiate Guidelines Network (SIGN)	www.sign.ac.uk/
5) Public Health Agency of Canada	www.phac-aspc.gc.ca
6) European network for Health Technology Assessment ( Eu net HTA)	www.hta.ac.uk
7) Australian Institute of Health and Welfare (AIHW)	www.aihw.gov.au/
8) World Health Organization (EMRO)	www.emro.who.int
	www.who.int.or
9) Guideline international Network (GIN)	www.g.n.net
10) New Zealand Guidelines Group (NZGG)	www.nzgg.org.nz
11) National Guideline Clearinghouse (NGC)	www.guideline.gov
12) National Comprehensive Cancer Network (NCCN)	www.nccn.org
13) Food and Drug Administration (FDA)	www.fda.org
14) Swiss Medical Association (FMH)	www.FMH.ch
15) Institute for Quality and Efficiency in Health Care (IQWIG)	www iqwig .de
16) American Society of Clinical Guide line Oncology (ASCO)	www.ASCO.org
17) National Institutes of Health (NIH)	www.nih.gov
18) Centers for Disease Control and Prevention (CDC)	http://www.cdc.gov/
19) http://www.thecochranelibrary.com
20) http://www.group.bmj.com/produccts/evidence-centre
21) www.hsa-sante.fr
22) www.sant.gouv.fr

Then they have selected at least five sources of them that were more relevant for each subject.

Then key questions have identified for each guideline, and Main table prepared for it including blank space for the answers of questions by each resources.

In front of each question, there was a space for entering of Iranian experts final opinion

For each question, there were at least five answers.

Gathering and summarizing the replies base on general consensus (Iranian experts) have considered for the answer of the each question (making group decision and reaching consensus). Their main purpose was to define levels of agreement on controversial subjects.

Sometimes, some of the guidelines have sent to scientific institution or experts of other universities to have more idea in this regard (Respected peers-those who have not been members of the guideline panel but were experts in the same field-should review guidelines for scientific validity. These outside reviewers should be acknowledged at the end of the guideline document).

At the end of this process, the authors have organized and finalized local guideline in a unified frame work.

Results

In this study, process of practice guideline adaptation has consisted of several steps. The Figure presents an overview of the steps.

At the end of this process, national health guidelines have written by team and all of guidelines had an identical framework:

Name of guideline: in Persian and English

Health professional Target groups: in Governmental and non-governmental sectors (private public,cooperative,NGO) centers, specially family doctors

Introduction and preface: should have the important points of epidemiology, cost, mortality, incidence, prevalence and burden of disease(s) in Iran and the world.

Preventive interventions: focusing on preventing risk factors of diseases.

For each group of health provider the duties and responsibilities have defined.

Diagnostic Interventions: have pots of history, physical examination, least priorities of laboratory-Test and imaging.

Proper care interventions: should have appropriate cost effectiveness, following, referring of patients and determine the responsibilities of rehabilitation.

Implementation: Responsibilities of MOHME, Universities of Medical Sciences and Health Services and other organization have defined for executing the guidelines.

In purpose of final editing, the guideline has returned to national main team for more investigating.

Guidelines have also reviewed by the Guidelines Review Committee for content and format. Each guideline group has submitted its final draft to the Guidelines Committee for approval.

The changes have performed and then afterword sent to the main team.

The main authors group has finalized the text and draft has forwarded to the IDSA Governing Council for editing and final approval then for registration by a special ID number.

In less than 5 months, more than 500 authors in whole country have prepared for educating co- workers about guidelines development and approximately 150 guidelines have provided in three volumes of the book published and distributed. At the beginning of each book the law and main national health policies that support the guidelines have notified. According to this supreme documents executing of all the strategies which have approved by MOHME in the field of health and treatment areas, including prevention, diagnosis, test requests, medical treatment, surgical interventions, follow-up, record keeping, patient information and health promotion stratification of medical services and referral process were mandatory for Ministry Cooperation, Labor and social welfare.

Figure 1

Summary of Practice Guideline Adaptation Cycle

Each guideline had a specific 4 components national ID number, containing official automation code, year of publication, and unique guideline code and version code. Guideline should be changed base on new evidences every 3-5 years; the version code all will be updated. The guideline leader could determine whether the scope of change warranted a full-scale revision of the guideline. Nowadays we have been preparing to establish an implementation program.

Discussion

The importance of guidelines as decision-making tools, for promoting evidence-informed practice, and serving as one of the foundations for improving health care efforts, has been shown scientifically [1].

Health systems guidance has shown the potential to improve decision-making and enable more efficient use of resources with consequent improvements in the health of populations.

However, such guidance needed rigorous and transparent processes of production and evidence-based approaches to ensure its dissemination and uptake [23].

Using clinical practice guidelines, especially when they have prepared by adoption method, could increase the quality of care in health care systems. Of course it needed extensive planning and coordination in different parts of the system fortunately promising approaches have been taken in our country in recent years [29].

The process of adaptation guidelines should be systematic, independent and transparent. The primary target groups have been the health professionals and the main responsibility for developing guidelines should rest with them and their organizations. Other interested parties - patients, funders, and policy makers - could be involved whenever appropriate. Guidelines should be available and understandable to these important target groups. Paying attention these objective, guidelines should be based firmly on scientific evidences, interpreted through professional experience and complemented by expert opinion whenever was necessary.

In the developing countries such as Iran adapting health guidelines in short and medium- term could be a proper way to obtain necessary and enough capacity to design national original ones. Also, several guidelines in each different topic would be available to be modified by our country, but, repetition alone was useless except in epidemic and special diseases. The revision of original guidelines as an alternative could be beneficial. Besides, using the modified guidelines could base on social economy.

Conclusion

International evidences have shown that using national guidelines could increase the quality of care in the health systems and avoid many mistakes and medical errors in developing countries.

According to this fact that national guidelines have minded very essential means for policy making in health care, MOHME should provide and distribute the guidelines based on its accountability to legal responsibility. Therefore, for all the governmental and nongovernmental sectors, institutions and organizations execution of them would be mandatory. In addition, we could consider our modifying and adapting health guidelines experiences as an innovation for developing countries.