Razi Journal of Medical Sciences

fa پروتکل طراحی و راه اندازی سامانه ثبت داده‌های اختلالات طیف اتیسم در شهر تهران Implementation of Regional Autism Spectrum Disorders Registry: Rationale and Study Protocol روان‌پزشکی Psychiatry پژوهشي Research زمینه و هدف: اختلال طیف اتیسم (ASD) یکی از اختلالات عصبی رشدی است که با آسیب در تعاملات اجتماعی و رفتارها، علایق و حرکات کلیشه‌ای و تکراری شناخته می‌شود. داده‌ها و اطلاعات این بیماری در سطح ملی محدود است و تفاوت‌های جغرافیایی به ندرت ارزیابی می‌شوند. انجام تحقیقات قوی در مورد اختلالات طیف اتیسم، مستلزم در اختیار داشتن تعداد نمونه زیاد برای شناسایی روند اپیدمیولوژیک این بیماری است. سامانه‌های ثبت یکی از روش‌های کارآمد هستند که می‌توانند این داده‌ها را در بازه زمانی طولانی و در سطح وسیع فراهم کنند. روش کار: هدف ارائه پروتوکل طراحی و راه اندازی سامانه ثبت بیماران مبتلا به اختلالات طیف اتیسم در شهر تهران با اهداف بالینی و پژوهشی است. جمعیت وارد شده در این سامانه شامل افراد (اعم از کودکان بالای 6 ماه و بزرگسالان) با تشخیص قبلی یا تشخیص جدید به مراکز تحت پوشش (درمانگاه روانپزشکی اطفال انستیتو روانپزشکی تهران، بیمارستان کودکان حضرت علی اصغر (ع)، بیمارستان رازی و بیمارستان روزبه و همچنین مطب‌های پزشکان عضو کمیته راهبردی برنامه) می‌باشد. بیمارانی وارد برنامه ثبت داده می‌شوند که تشخیص   ASD توسط متخصصین بر اساس معیار تشخیصی DSM-5 تأیید شده باشد. پیگیری بیماران به صورت تماس تلفنی با بیمار و مراجعه مجدد بیمار به مراکز تحت پوشش انجام خواهد شد. تحلیل داده‌ها متناسب با اهداف برنامه ثبت و بر اساس روش‌های مرسوم آماری انجام می‌شود. همچنین، گزارش سالانه‌ای از پروفایل بیماران ثبت شده در پایان هر سال برنامه در اختیار ذی‌نفعان برنامه از جمله معاونت تحقیقات دانشگاه‌های مشارکت کننده در برنامه، وزارت بهداشت و انجمن‌ها و گروه‌های مرتبط ارسال می‌شود. یافته‌ها :4/55 درصد بیماران پسر و 6/44 درصد دختر بودند. بیشترین میزان نگرانی والدین در سال سوم زندگی است. بیشترین میزان مراجعه به روانپزشکان و سپس متخصصان مغز و اعصاب بود و پس از اتیسم (4/53 %) بیش فعالی با 8/24 % بیشترین تشخیص‌های مطرح شده بودند. 20 % کودکان تشنج هم داشتند، 8/14 % وزن کم موقع تولد و 23 % وزن بیش از حد طبیعی داشتند. 5/15 % زردی طولانی پس از تولد داشتند و فقط 4/24 % بچه‌ها از طریق زایمان طبیعی به دنیا آمده بودند. در 8/32 % سابقه سقط وجود داشت. بعد از گرفتن تشخیص 9/66 % از کودکان کمتر از 10 جلسه در ماه در جلسات توانبخشی شرکت کرده بودند. نتیجه‌گیری: ایجاد سامانه‌های ثبت بیماری‌ها به خصوص بیماری‌های مزمن یک نیاز ضروری برای کشورها به نظر می‌رسد تا سیاست‌گذاران حوزه سلامت بتوانند براساس آن در جهت ارتقای سطح سلامت، سیاست‌گذاری‌های صحیح و برنامه‌ریزی‌های خرد و کلان تصمیم گیری کنند. یکی از ویژگی های بسیار مهم سامانه‌های ثبت، ثبت بیماران در بازه زمانی طولانی و امکان گسترش جمع‌آوری بیماران در سطح کشور است.  اختلالات طیف اتیسم نیز به دلیل شیوع نسبتاَ زیاد، گسترش روز افزون و بارمالی زیادی که برای جامعه تحمیل می‌کند، یک مورد مناسب برای ایجاد سامانه ثبت است تا بتوان با ثبت تمام اطلاعات بالینی و اپیدمیولوژیکی عوامل محیطی، ژنتیکی و شیوع آن را مورد بررسی قرار داد.   <div style="text-align: justify;">Background & Aims: Introduction: Autism Spectrum Disorder (ASD) is a neurological developmental disorder characterized by impaired social interactions, stereotypic movements and repetitive and limited behaviors and interests. Given the increasing statistics of autism in children in the world and in Iran, the extent of problems and burdens that this disorder creates for the child, family and society, it is a necessity to identify the causes and factors related to ASD. Moreover, data on this disorder are limited nationally and geographical differences are rarely assessed. To conduct great research on autism spectrum disorders requires a large number of samples to identify the epidemiological trend of the disorder. Registrations are one of the efficient methods that can provide this data in a long time and on a large scale. The purpose of this study is to describe the steps of designing and launching an autism registration system in Tehran, which can be a prelude to creating a system at the national level. Methods: In this study, the aim was to present a protocol to design and launch a registry for patients with autism spectrum disorders in Tehran for clinical and research purposes. The entered population in this system includes individuals (including children over 6 months and adults) with previous diagnosis or new diagnosis referred to the certain centers (Child Psychiatric Clinic of Tehran Psychiatric Institute, Ali Asghar Children's Hospital, Razi Hospital and Roozbeh Hospital) and also, physicians' offices who are members of the program's strategic committee. Patients are admitted to the program if the diagnosis of ASD is confirmed by a pediatrician, child neurologist, psychiatrist, neurologist, psychiatrist, neurologist, child psychologist according to the DSM-5 diagnostic criteria. Then personal and demographics information and clinical and laboratory findings will be recorded by data entry experts in the system. Patients will be followed up by telephone or through coming back of the patients to the certain centers. Data analysis is done in accordance with the objectives of the registration program and is performed based on conventional statistical methods. Also, an annual report of the profiles of registered patients is sent to the beneficiaries of the program at the end of each year, including the Vice Chancellor for Research of the participating universities, the Ministry of Health, and related associations and groups. Initially, stakeholders in the field of autism spectrum disorders from different and related specialties were identified from partner universities of medical sciences in Tehran (Iran, Tehran, Welfare Sciences) and various centers accepting autism spectrum patients and the Strategic Committee for Autism Registration as a subset of the Vice Chancellor for Research was established in 1398 in Iran University of Medical Sciences. The Strategic Committee is responsible for developing guidelines and executive protocols consisting of experts in the fields of general psychology, child psychology, social medicine, epidemiology, information technology, health informatics and health information management, as well as the executive committee and executive groups for follow-up and conducting decisions of Strategic Committee was considered. Data Management and Information Technology (IT) Department was  Responsible for Software Design; Data collection and quality control group was responsible for data collection, quality control, feedback and data correction; The epidemiology and data analysis team was also responsible for designing and conducting the data analysis program. The population entered in this system includes people (including children over 6 months and adults) with previous diagnosis or new diagnosis of the referral centers. A child is considered to have diagnostic criteria for autism spectrum disorders according to the DSM 5 Diagnostic Guide if he or she has serious impairments in communication and social interactions as well as a limited and repetitive pattern of behavior, interests, and activities. Patients enrolled in the program have been diagnosed with ASD by a pediatrician, child psychiatrist, pediatric neurologist, psychiatrist, or neurologist. Child Psychiatric Clinic of Tehran Psychiatric Institute, Ali Asghar Children's Hospital, Razi Hospital and Roozbeh Hospital and also physicians' offices who are members of the program's strategic committee are covered now. Based on the objectives of the Strategic Committee and literature review for the design of registration systems, the following data collection was considered:</div> <ul> <li style="margin-left: 8px; margin-bottom: 13px; text-align: justify;">Personal and socio-demographic characteristics (such as name, age, gender, ethnicity, parents' relatives, place of birth and residence, birth rank, education)</li> <li style="margin-left: 8px; margin-bottom: 13px; text-align: justify;">Clinical information (such as history of developmental delay, name of the disorder, presence of seizures, presence of mental retardation and other psychiatric diagnoses, personal and family history of the disorder)</li> <li style="margin-left: 8px; margin-bottom: 13px; text-align: justify;">Laboratory and imaging finding</li> </ul> <div style="text-align: justify;">Then personal and demographics information and clinical and laboratory findings will be recorded by data entry experts in the system. Patients will be followed up by telephone or through coming back of the patients to the certain centers. Data analysis is done in accordance with the objectives of the registration program and is performed based on conventional statistical methods. Also, an annual report of the profiles of registered patients is sent to the beneficiaries of the program at the end of each year, including the Vice Chancellor for Research of the participating universities, the Ministry of Health, and related associations and groups. In order to validate and evaluate the feasibility and ease of implementation of the data collection form, this form was piloted in several centers and then based on the results of experimental implementation, the questions were reviewed and finalized. After compiling the final version of the data collection form, the software registry system was designed for the web. In order to maintain data security, a separate access and a specific access level for each user is determined and hosted on the servers of Iran University of Medical Sciences. Data analysis is done in accordance with the objectives of the registry and is performed based on the required statistical methods. Also, an annual report on the profile of registered patients of the registry is sent to the beneficiaries of the program at the end of each year, including the Vice Chancellor for Research of the participating universities, the Ministry of Health and related associations and groups. In 2014, the Deputy Minister of Research at the Ministry of Health and Medical Education (MOHME) of Iran decided to establish registration systems for various diseases and health consequences (4). In this regard, the launch of a clinical-research registry in autism in Tehran was considered. Setting up an autism spectrum disorder information registry in Tehran as a preliminary study for its establishment at the national level can help to integrate research activities and create a research network and prevent incoherence, rework and waste of time and energy in related research activities in the country. In addition to the direct use of data for research activities, such systems can also be used to identify patients eligible for clinical trials. In addition, it is possible to study the natural course of this disorder, track individuals and help increase the country's indigenous knowledge based on local and regional information. In addition, launching a program to record the autism spectrum disorders will help policymakers and health planners in the country to decide and plan for it. In addition, is not possible for policy makers to plan in an integrated, comprehensive, accurate and up-to-date way without having access to such online information systems. In the long run, this study aims to record all ASD information across the country in this system to eliminate the huge challenges of patients, physicians and health decision makers and also Smoothing the way for research further. Conclusion: Establishing registry systems, especially chronic diseases seems to be a need for work so that health policy makers can make the right policies and plans to improve the level of health. One of the most important features of registries is the enrolling of patients in the time period and the possibility of increasing the collection of patients in the country. Due to the relatively high prevalence large number of causes and increasing high financial burden of autism spectrum disorders that it imposes on society, it is a suitable c case to evaluate prevalence, environmental and genetic factors through recording all clinical and epidemiological information</div> اختلال طیف اتیسم (ASD), سامانه ثبت داده, معیار تشخیصی DSM-5 Autism Spectrum Disorder (ASD), Data Registry System, DSM-5 Diagnostic Criteria 173 182 http://rjms.iums.ac.ir/browse.php?a_code=A-10-3654-1&slc_lang=fa&sid=1 Batool Tayefi بتول طائفی 3900319475328460074319 3900319475328460074319 No Preventive Medicine and Public health Research Center, Psychosocial Health Research Inistitue, Community and Family Medicine Department, School of Medicine, Iran University of Medical Sciences, Tehran, Iran مرکز طب پیشگیری و سلامت عمومی، انستیتو تحقیقات سلامت روانی اجتماعی، دپارتمان طب خانواده و جامعه نگر، دانشکده پزشکی، دانشگاه علوم پزشکی ایران، تهران، ایران Abbas Sheikhtaheri عباس شیخ طاهری 3900319475328460074320 3900319475328460074320 No Department of Health Information Management, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran گروه مدیریت اطلاعات سلامت، دانشکده مدیریت و اطلاع رسانی پزشکی، دانشگاه علوم پزشکی ایران، تهران، ایران Leila Ghalichi لیلا قالیچی 3900319475328460074321 3900319475328460074321 No Assistant Professor, Iran University of Medical Sciences, Tehran, Iran استادیار، دانشگاه علوم پزشکی ایران، تهران، ایران Omid Pornik امید پورنیک 3900319475328460074322 3900319475328460074322 No Assistant Professor, Iran University of Medical Sciences, Tehran, Iran استادیار، دانشگاه علوم پزشکی ایران، تهران، ایران Hadi Zarafshan هادی زرافشان 3900319475328460074323 3900319475328460074323 No Department of Autism & Neurodevelopmental Disorders, Psychiatry & Psychology Research Center, Tehran University of Medical Sciences دپارتمان اتیسم و اختلالات عصبی تکاملی، مرکز تحقیقات روانپزشکی و روان شناسی، دانشگاه علوم پزشکی تهران، بیمارستان روزبه، تهران، ایران Mitra Hakim Shooshtari میترا حکیم شوشتری mitra.hakim@gmail.com 3900319475328460074324 3900319475328460074324 Yes Professor, Iran University of Medical Sciences, Tehran, Iran استاد، بیمارستان کودکان علی اصغر، دانشگاه علوم پزشکی ایران، تهران، ایران Roya Esmailzade رویا اسماغیل زاده 3900319475328460074325 3900319475328460074325 No Iran University of Medical Sciences, Tehran, Iran انستیتو روانپزشکی تهران، دانشگاه علوم پزشکی ایران، تهران، ایران