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## Toward a new generation of quality registries for neurodevelopmental disorders: the example of NEUROPSYK

Anna Löfgren Wilteus 1;2 ; Frida Bartonek 1;2 ; Jacqueline Borg 1;3 ; Sven Bölte 1;2*

1 Center of Neurodevelopmental Disorders at Karolinska Institutet (KIND); Pediatric Neuropsychiatry Unit;

Dep. of Women's and Children's Health; Karolinska Institutet; Stockholm; Sweden 2 Child and Adolescent Psychiatry; Center for Psychiatry Research; Stockholm County Council; Sweden 3 Karolinska PET Center; Dep. of Clinical Neuroscience; Karolinska Institutet; Stockholm; Sweden

*Corresponding author: sven.bolte@ki.se

## Abstract

Swedish healthcare quality registries are tools for the evaluation and improvement of clinical services and population-based research.  There  are  presently  11  national  quality  registries  that  focus  on  psychiatric  disorders;  but  none  cover  all neurodevelopmental disorders (NDDs) as defined by the International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) . Health care professionals have called for more user-friendly; time-saving; and clinically informative registers.

To  fill  this  gap,  the  NEUROPSYK  Quality  Register  was  established  in  2014  by  the  Center  of  Neurodevelopmental Disorders at Karolinska Institutet. Initially, this was a clinical register of child and adolescent psychiatry for the Stockholm County Council.

The main objectives of NEUROPSYK are to improve the assessment of and interventions used for individuals with NDDs by doing the following: 1) supporting adequate follow-up related to the implementation of existing regional and national guidelines for  assessment and  treatment; 2)  providing clinical decision-making aids; and 3)  conducting large-scale clinical epidemiological research. The registry incorporates all legal requirements for quality registries in Sweden.

NEUROPSYK includes patients of all ages diagnosed with NDDs per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. These  diagnoses  include  autism  spectrum  disorder,  attention-deficit/hyperactivity  disorder,  intellectual disabilities,  communication  disorders,  specific  learning  disorders,  and  motor  disorders.  Medication  and  behavioral interventions are recorded and patient outcomes over time are measured with the economical and user-friendly Clinical Global Impression tool, the Global Assessment of Functioning instrument, and patient-reported health-related quality of life.

NEUROPSYK minimizes administrative work for health care professionals because it is integrated with structured digital patient records, thereby increasing the likelihood of high coverage and data quality. NEUROPSYK combines several strengths to exemplify a new generation of quality research registers for use in psychiatry and other areas of health care.

Keywords: Autism; ADHD;  epidemiology; implementation; quality management; assessment; psychiatry; register; neurodevelopmental disorders

Read more about NEUROPSYK: http://ki.se/en/kind/neuropsyk-quality-registry-for-neurodevelopmental-disorders

## Background

Approximately  10%  of  the  general  population  is affected  by  neurodevelopmental disorders (NDDs) (1). Recently, NDD  diagnoses have increased markedly  in  Sweden  and  elsewhere  in  the  world, which  has  posed  a  challenge  to  many  health  care providers. For example, between 2001 and 2011, the prevalence  of  diagnosed  autism  spectrum  disorder (ASD) increased 3.5-fold among Stockholm children between the ages of 0 and 17 years (2). The increase in the prevalence of ASD  without intellectual disability was almost 8-fold, from 0.14% to 1.10%. In addition,  the  prescription  of  methylphenidate  for attention-deficit/hyperactivity disorder (ADHD) increased from 1.2% in 2006 to 4.6% in 2014 among males between the ages of 10 and 17 years (3). In Sweden in 2014, a total of 58,600 individuals with ADHD were treated pharmacologically (4).

Regional  and  national  health  care  authorities  in Sweden  have  generated  clinical  guidelines  for  the assessment  and  treatment  of  NDDs  to  improve evidence-based  practice  and  comparable  services across  providers  and  regions  (5-7).  However,  no systematic  means  have  yet  been  implemented  to determine  whether  recommended  diagnostic  and treatment procedures are followed, and individuals in the health care system are not being tracked across their  NDD  diagnoses,  ages,  and  types  of  service providers. To achieve this goal locally, regionally, and nationally,  data  about  health  care,  outcomes,  and patient pathways are needed. One efficient strategy to  use  to  obtain  this  is  the  implementation  of healthcare quality registries (QRs).

QRs in Sweden serve as important tools for  the evaluation and improvement of health care services, and they provide a primary data source for epidemiological  and  longitudinal  research (8-10). QRs contain individualized information about patients' diagnoses, diagnostic assessments, medical interventions, treatment outcomes, and patientreported outcome measures. In 2016, a total of 108 different national QRs were approved and monitored  by  the  Swedish  Association  of  Local Authorities and Regions (11). Eleven of these QRs included psychiatric disorders. With the exception of children  with  ADHD,  a  majority  of  patients  with NDDs are not included in the existing registries at all (Table 1). For example, individuals with ASD in the normative intelligence range are not yet included in current  QRs,  and  there  are  no  QRs  to  cover  any language or speech disorders. Most current registers cover only certain NDD  diagnoses  (e.g., only ADHD), only patients referred to a specific type of organization  (e.g.,  child  and  adolescent  psychiatry), or  only  adults.  Long-term  follow-up  of  patients' pathways in health care is needed throughout childhood  and  adolescence  and  into  adulthood. Information is needed from the different professions involved (e.g., pediatricians, neurologists, psychologists,  speech  therapists)  as  well  as  from different care units (e.g., pediatric units, habilitation centers,  child-  and  adolescent  psychiatry,  speech therapy, adult psychiatry). Hence, there is a need to implement a registry that covers the full health care pathways and outcomes for patients with all NDDs across their lifetimes.

TABLE 1. Overview of quality registries that include patients with psychiatric disorders in Sweden

| Registry name     | Registry focus                           | Diagnoses included                                                                                                                                 | Ages          | No. of patients in registry (n)                | Completeness (%)   |
|-------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------|------------------------------------------------|--------------------|
| BipoläR           | Bipolar disorders                        | Bipolar disorders                                                                                                                                  | All ages      | 8373                                           | 28%                |
| BUSA              | Attention-deficit/hyperactivity disorder | Attention-deficit/hyperactivity disorder and attention deficit disorder                                                                            | All ages      | 5689                                           | 10%                |
| ECT               | Electroconvulsive therapy                | Not specified                                                                                                                                      | All ages      | 3664                                           | 89%                |
| HabQ              | Habilitation services                    | Cerebral palsy, autism (low functioning), and other not specified diagnoses                                                                        | Children      | Cerebral palsy, 569; autism, 345; others, 1120 | No information     |
| Kvalitetsstjärnan | Psychosis and schizophrenia              | Psychosis and schizophrenia                                                                                                                        | Adults        | 3000/year                                      | No information     |
| NEUROPSYK         | Neurodevelopmental disorders             | Autism spectrum disorders, attention- deficit/hyperactivity disorder and attention deficit disorder, dyslexia, Tourette syndrome, stuttering, etc. | All ages      | 896                                            | No information     |
| PsykosR           | Psychosis and schizophrenia              | Psychosis                                                                                                                                          | All ages ages | 7923 2600/year                                 | 23%                |
| RIKSÄT            | Eating disorders                         | Eating disorders                                                                                                                                   | All           |                                                | 90%                |
| Rättspsyk         | Forensic psychiatry                      | Not specified                                                                                                                                      | Adults        | 1728                                           | 86%                |
| SBR               | Addictive behavior                       | Addiction (e.g., opiates)                                                                                                                          | Adults        | 4078                                           | 15%                |
| SIBeR             | Internet treatment                       | Depression, phobias, etc.                                                                                                                          | All ages      | No information                                 | No information     |
| Q-BUP             | Child and adolescent health care         | All diagnoses                                                                                                                                      | Children      | 0                                              | 0%                 |

Information about the number of patients in each registry and the registry's completeness has been retrieved from that registry's annual report or from the National Board of Health and Welfare (Completeness 2015 - Comparisons between Swedish Healthcare Quality Registries and government-administered health registries)

## Objectives

The NEUROPSYK Quality Register was established in  2014  by  the  Center  of  Neurodevelopmental Disorders at Karolinska Institutet, and it initially and formally  considered  a  clinical  register  of  child  and adolescent psychiatry for Stockholm County Council. The register's objective is to collect data for all patients who receive diagnoses within the NDD categories of the DSM-5  regardless of service provider or age, in the country of Sweden (Table 2).

Current ICD-10 diagnoses are converted with the use of  the  recommended  ICD-10  diagnosis  synopses from  the  DSM-5 . This  includes  ASD,  ADHD, intellectual disabilities, communication  disorders, specific learning disorders, and motor disorders (see Table  2).  Due  to  the  considerable  comorbidity between these types of conditions and other psychiatric and somatic disorders, it is advantageous to include all NDD  diagnoses  and  co-existing disorders in the same registry to enable follow-up for all  patients  who  are  not  included  in  other  QRs  at present. Service  providers  who  are  included  or planned to be included are the following: child and adolescent  psychiatry,  adult  psychiatry,  habilitation services, speech therapy providers, pediatric neurology and medicine, and clinical genetics.

TABLE 2. International Statistical Classification of Diseases and Related Health Problems; 10 th  Revision diagnoses included in NEUROPSYK

| DSM-5 Category                                                                                                                                                                           | ICD-10 diagnoses as defined in DSM-5                                                                                                                           | Other relevant ICD-10 diagnoses included   |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Intellectual disability Communication disorders Autism spectrum disorders Attention-deficit/hyperactivity disorder Learning disorders Motor disorders Other neurodevelopmental disorders | F70; F71; F72; F73; F79 F80.9; F80.0; F80.8 F84.0 F90.2; F90.0; F90.1; F90.8; F90.9 F81.0; F81.1; F81.2 F82; F98.4; F95.2; F95.1; F95.0; F95.8; F95.9 F88; F89 | F98.5 F84.5; F84.1; F84.9                  |

DSM-5; Diagnostic and Statistical Manual of Mental Disorders; Fifth Edition Category

ICD-10; International Statistical Classification of Diseases and Related Health Problems; 10th Revision

## Methods

Unlike  traditional  Swedish  QRs,  NEUROPSYK  is integrated with patient medical records and requires minimal administrative work for health care professionals. This curtails any unnecessary workload and increases the likelihood of both high coverage of the target population and data validity. For  all  consenting  patients,  a  limited  number  of essential and informative health measures are retrieved automatically. This allows for an accessible system that requires minimal administration. NEUROPSYK was first implemented in the largest Swedish  county  (Stockholm)  through  integration with the medical record software 'Take Care,' which is used by both private and county council managed care  units.  Every  24  hours,  data  for  the  chosen variables are retrieved from  the patient record database and sent via a secure health care connection to the registry platform, where they are saved and can be used for feedback to care providers on different levels. For example, service management can easily access  online  statistics  related  to  resources  used, treatments administered, and improvement in global functioning and quality of life over time for different patient groups.

In addition to information about the patient (e.g., personal  identity  number,  ICD-10  diagnosis),  the registry includes data about each episode of patient contact with the care provider, including the following:  the  date  of  each  visit,  the  profession(s) involved  in  the  care  (e.g.,  physician,  psychologist, social  worker,  special  education  teacher),  and  the type  of  visit  (e.g.,  home  visit,  group  treatment, individual  consultation)  (Table  3).  In  addition,  the registry includes information about what pharmacological  treatments  were  prescribed  (ATC codes) and the defined daily dose. Other treatments and  interventions  are  coded  using  the  Swedish classification of health interventions (i.e., the KVÅ

code, which may refer to neuropsychiatric assessment, cognitive behavioral treatment, or patient education in a group). Process measures (e.g., medications, types of behavioral intervention), outcome measures (e.g., Clinical Global Impression, Global  Assessment  of  Functioning),  and  patient reported data (e.g., EQ-5D/DISABKIDS) are included.

NEUROPSYK  also  provides  patient  overviews, which  are  useful  for  clinical  routines  and  easily accessible from the medical record through a single sign-on  for  authentication. The  overview  includes the patient's diagnoses as well as his or her current health status (i.e., Global Assessment of Functioning), quality of life (i.e., EQ5D/DISABKIDS), medications,  interventions,  and health care contacts over time (Figure 1). The patient overview  can  be  used  to  plan  and  follow  up  on interventions for the patient.

NEUROPSYK can also be used for register-based research, provided that ethical approval is obtained for a specified research project and that the registry board  has  accepted  the  project.  In  principle,  any researcher can access NEUROPSYK, and the same roles apply as for any Swedish QR. For example, the registry  can  be  used  to  study  characteristics  of outpatients diagnosed with NDDs (e.g., trajectories, comorbidities, functioning, disability pension, quality of life). Furthermore, studies of the transition from child and adolescent health care to adult health care for  persons  with  NDDs  and  adherence  to  clinical guidelines can be performed. Studies of the effects of perinatal and other environmental factors on NDDs can  occur  with  the  use  of  information  from  other QRs and national health statistics.

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| TABLE 3. Data retrieved from patient records in NEUROPSYK                                                 |                                                                                                                                                                    |
|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Variable                                                                                                  | Description                                                                                                                                                        |
| Patient identification and diagnosis                                                                      |                                                                                                                                                                    |
| Personal identity number                                                                                  | Unique 10-digit number including information about birthday (YYMMDD) and sex (male/female)                                                                         |
| International Statistical Classification of Diseases and Related Health Problems, 10th Revision diagnosis | Primary and additional diagnoses                                                                                                                                   |
| Care provider-related information                                                                         |                                                                                                                                                                    |
| County Health care unit/department                                                                        | County where the caregiver is located Caregiver unit unique identity number Home visit, group treatment, telephone All types of visits or contacts                 |
| Type of visit                                                                                             | contact, etc.                                                                                                                                                      |
| Visit date/contact date                                                                                   | (consultations, home visits, phone calls, etc.)                                                                                                                    |
| Number of professionals meeting patient                                                                   | Maximum of 5 professionals per visit                                                                                                                               |
| Professions involved in the consultation                                                                  | Type of professions involved in patients' care (e.g., physician, psychologist, occupational therapist, social worker, special education teacher, speech therapist) |
| Teatment and interventions                                                                                |                                                                                                                                                                    |
| Anatomic Therapeutic Chemical classification system (ATC code) Defined daily dose (DDD)                   | Pharmacological treatment Amount of each medication taken each day                                                                                                 |
| Klassifikation av vårdåtgärder code (KVÅ code)                                                            | Swedish classification of health and medical interventions                                                                                                         |
| Clinician-rated measures                                                                                  |                                                                                                                                                                    |
| Global Assessment of Functioning (GAF)                                                                    | Assessment of functioning for adults                                                                                                                               |
| Children's Global Assessment Scale (CGAS)                                                                 | Assessment of functioning for children 0 to 18 years old                                                                                                           |
| Children's Global Assessment Scale for Developmental Disabilities (DD-CGAS)                               | Assessment of functioning for children 0 to 18 years old                                                                                                           |
| Clinical Global Impression-Severity (CGI-S)                                                               | Severity of the condition                                                                                                                                          |
| Patient reported measures EQ-5D DISABKIDS                                                                 | Self-reported health-related quality of life for adults Proxy or self-reported health-related quality of life for children and adolescents                         |

FIGURE 1. Patient overview

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The  variables  in  the  registry  were  selected  on  the basis of current clinical guidelines and in response to the  consensus of  a  reference  group.  The  reference group  consisted  of  20  clinicians,  stakeholders,  and registry and information technology experts as well as  policy  makers  (e.g.,  psychiatrists,  pediatricians,

·DD CGAS

·CGI

psychologists, speech therapists, researchers, managers,  health  care  officials,  experts  on  quality registries and information technology). The process started in 2011, with four reference group meetings held  to  discuss  aims,  variables,  and  technological solutions.  Further  discussions  were  held  in  smaller working  groups,  and  a  board  consisting  of  12 members was formed. The NEUROPSYK board has representatives  from  health  care  (i.e.,  child  and adolescent psychiatry, adult psychiatry, pediatric units, habilitation centers, speech therapy, and school nurses), research (i.e., psychiatrists, pediatricians, and psychologists), information technology experts, and non-governmental organizations. The register adheres  to  all  legislative  requirements  for  national QRs in Sweden, which are mainly delineated in the Swedish  Patient  Data  Act.  NEUROPSYK  is  a formally  approved  care  register  of  the  Stockholm County Council, and it has also been accepted by the Swedish Association of Local Authorities and Regions.

## Pilot project

Starting  in  2013,  five  care  units  participated  in  the development of registry routines and technological solutions. In 2015, the registry was integrated with the medical record system in Sweden's largest county (Stockholm), and the QR was used by five pilot units as a regional system. The development process was done  in  close  collaboration  with  each  of  the  five public and private health service representatives and providers, interested organizations, and existing psychiatric  registries  in  Stockholm  County  Council and beyond (e.g., BUSA, a national quality registry for  structured  follow-ups  of  patients  with  ADHD both children and adults; see Table 1). The development  of  the  registry  was  guided  by  legal experts  from  the  Stockholm  County  Council  to ensure compliance with the legal requirements related to patient rights and data safety.

The  pilot  use  of  this  registry  was  an  iterative process that involved technicians, multi-professional clinicians from various departments, and researchers. The  following  objectives  were  kept  in  mind:  1)  to optimize information technology and connect to the electronic clinical file system in clinical reality; 2) to enhance  user  feasibility;  3)  to  generate  automatic informative statistics and reports for clinicians; 4) to collect experiences with the adequate implementation of the register into existing clinical routines; 5) to encounter and solve user reservations; and 6) to examine the use of the registry in terms of clinical and research utility and validity.

NEUROPSYK is currently operating as a regional quality  registry  in  Stockholm  County  so  that  its feasibility  can  be  examined;  the  eventual  goal  is  to implement it as a national QR. As of October 2016, NEUROPSYK contained more than 1000 patients with  NDDs  who  were  enrolled  from  13  different units.

## Future plans and developments

An evaluation of the pilot project is planned that will focus  on validation, data quality, and  the user experience. Another objective is to develop a way for this system to integrate with the national platform, with the goal of transferring data from patient record systems  all  over  Sweden  into  NEUROPSYK.  The recruitment of care providers from all over Sweden as well as the training of clinicians in how to assess global functioning is ongoing. A long-term goal is to collect more data regarding which diagnosis-specific standardized  instruments  are  most  often  used  by clinicians. We are continuously lobbying for structured  variables  to  be  created  by  the  county councils for this purpose.

Feedback from patients and their family members is invaluable to improve quality of care. In NEUROPSYK,  web-based  questionnaires assess patient-reported outcome measures related to health status, quality of life, and satisfaction with care via a home computer or a tablet in a health care waiting room. Outcomes of patient-reported measures can be  used  for  planning,  treatment,  and  follow-up before, during, and after consultations. However, the collection of patient-reported measures has not been implemented  in most  of the participating care providers; this is planned for the future.

## Conclusions

QRs in Sweden are unique resources to improve the quality of healthcare and to provide large amounts of data  for  epidemiological  research.  Despite  these benefits,  QRs  have  been  criticized  for  increasing administrative  work  for  health  care  professionals. Managers and health care recipients have called for more  user-friendly and time-saving systems for following  up  on  the  quality  of  care  received.  As  a result, a new generation of QRs with a higher degree of integration with patients' medical  records is emerging. NEUROPSYK is an example of the next generation of QRs, and it has been developed with the aim  of providing  an  efficient tool for the improvement of health care. NEUROPSYK includes real-time follow-up evaluations of health care interventions; this differs  from  traditional  QRs, which  record  patient  responses  via  separate  webbased forms that may be separated from the health care experience being assessed by weeks or months. With  the  use  of  real-time  information  related  to actual treatment pathways for these patients, improved collaboration among different health care units and professions can be achieved and may result in  reduced  waiting  times,  the  earlier  discovery  of NDDs,  and  earlier  intervention.  The  continuous collection of relevant clinical data from both public and private providers will also make it possible for health  care  authorities  and  politicians  to  optimize health care by  allowing  for the  more  effective allocation of resources to the care of children with NDDs and their families.

## Acknowledgements

NEUROPSYK  is  support  by  the  Swedish  Research Council, Vinnova, FORTE, Formas, Sällskapet Barnavård, the Swedish Association of Local Authorities and  Regions,  and  the  Stockholm  County  Council.  We would like to thank all patients who consented to take part in this project. We would also like to thank ADHD-center (Stockholm County Council), Autismcenter för barn och ungdom  (Stockholm County Council),  BUP  KIND (Division of Child and Adolescent Psychiatry, Stockholm County Council), Carmona AB, E-hälsa och IT (Stockholm County Council), Prima Child and Adolescent Psychiatry  Järva,  Prima  Adult  Psychiatry  Åkersberga, Registercentrum  Sydost  and  SLL-IT  Stockholm  County Council.

## Conflict of Interest statement/disclosure

None of the authors reports a direct conflict of interest related to this article. Bölte discloses that he has, in the last 5  years,  acted  as  an  author,  consultant,  or  lecturer  for Shire, Medice, Roche, Eli Lilly, Prima Psychiatry, GLGroup, System Analytic, Kompetento, Expo Medica, and  Prophase.  He  receives  royalties  for  textbooks  and diagnostic tools from Huber/Hogrefe, Kohlhammer, and UTB. Borg has received compensation as a member of the scientific advisory board of Astra Zeneca.

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