Implementing PROMIS in quality Registries John Chaplin Institute for Clinical Sciences, Sahlgrenska Academy at Gothenburg University, Sweden

Quality Registries in Sweden Mostly initiated by health professionals. 107 Quality Registries (QRs) administered by 6 regional competence centres. QRs contain individualised data on: patient demographics medical interventions structure and process of care (incl. PREM) outcomes after treatment (incl. PROM) PURPOSE to collect individual-based clinical data to examine and improve the delivery of healthcare. Recorded data are used for quality improvement, monitoring of adherence to guidelines and research any person can apply for data from a QR for research purposes provided the research project is approved by an ethics review board

There are 107 Swedish Healthcare Quality Registries (QR) The first Swedish QR, started in 1975. In the past two decades, an increasing number of nationwide QRs focusing on specific disorders have emerged. even if other groups of health professionals (e.g. registered nurses, psychologists and physiotherapists) are usually represented 107 Registries, Apr 2016

QRs in different healthcare categories

In total 90 % use some kind of PROM Some use the same PROM – EQ5D is used by 35 registries / SF36 by 10 registries.

What are the pressures for further PROM development? Push from Swedish Association of Local Authorities and Regions – funding is tied to the collection of PROM data. Difficulty with licence agreements with other systems. Need to maintain low costs while maintaining quality. Pull from Increased awareness, availability and use of PROM measures in Swedish. Awareness of need for electronic presentation of questions and collection of data (eHealth).

A series of studies have been conducted Conclusions The future belongs to item banking. Due to long development time it is wise to start from an existing item bank system. PROMIS is today the most interesting option for a national measure in Sweden. the comprehensive collection of dimensions – the possibility of integrating disease-specific Item banks into a common system.

Swedish national item bank project - 2016 Aim To encourage / stimulate the Quality Registries to adopt PROMIS. Project management: Evalill Nilsson, QRC Stockholm evalill.nilsson@ki.se (project leader) John Chaplin, Gothenburg University john.chaplin@gu.se Steering group: Staffan Lindblad (QRC Stockholm), Jack Lysholm (RCN), Anders Tennlind (RCSO), Thomas Troëng (RC Syd), Ulrika Frithiofsson (RC VGR) and Monica Sterner (UCR); representing each of the six Swedish RCs (Registry Centers)

Strategy for implementation Initial phase aims to have the first item bank and CAT by the end of 2016. Translation and validation of PROMIS item banks likely to be useful to the largest number of QRs. Develop a Swedish CAT demo. Workshops and seminars to inform and identify potential future users and stakeholders. Establishment of a Swedish network of active users and researchers working with item banks. Outline a secure national data collection methodology. Establishment/participation in European/Nordic PROMIS cooperation.

Results Translation of PROMIS paediatric and adult item banks, profiles and short forms. Support of independent translation projects incl. Paediatric profile-25 and NeuroQoL item banks. Established contact with a range of stakeholders and experts.

Results Cognitive debriefing carried out and protocols established. Ongoing validation studies and others planned. Pilot methodology for CAT identified

Swedish translations Fatigue + cancer version Adult Patient group Research group PROMIS Fatigue + cancer version Emotional depression + cancer Swedish national Item bank project Pain – Interference/ intensity + cancer Physical Function - Adult & Child Ability to Participate in Social Roles and Activities Global Helath-10 / Pediatric Global Health NeuroQoL Fatigue   Multiple sclerosis Dept of Clinical Neuroscience, Karolinska Institute Cognition general concerns Ability in social roles and activities - SF Participation in social roles and activities - SF Lower extremity function -SF Upper extremity function -SF Positive affect and well-being -SF

PROMIS in Sweden– Sept 2016 ADULT PROMIS Swedish translations   Swedish translations Patient group Research group ADULT Fatigue short form-7 post-polio Department of Rehabilitation Medicine, Skåne University Hospital in Lund Sexual function cancer patients & gen. population 16-39 yrs Dept. Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm PROMIS-29 profile Systemic sclerosis Department of Clinical Sciences, Dept of Rheumatology, Lund University PROMIS   Swedish translations Patient group Research group PEDIATRIC Emotional distress- Anxiety + proxy Asthma Center for Health Care Sciences Örebro University Hospital, Örebro Emotional distress – Depression + proxy Peer Relationships + proxy Fatigue + proxy Pediatric Profile-25 Orthopaedic Musculoskeletal Swedish paediatric orthopaedic register (SPOQ)

Ongoing validation studies PROMIS-25 Paediatric Orthopaedic Quality Registry (SPOQ) 100-150 patients from Gothenburg Paediatric Diabetes Clinics Gothenburg & Stockholm n=100 Paediatric item banks Asthma patients 8-16 years and parents (n=389) treated at Örebro University Hospital, June 2015 - Sept. 2016 NeuroQoL – MS Registry (SMSreg) 100-250 patients (potentially c.14 500)

Future organisation of PROMIS in Sweden technical management knowledge management administrative support

The technical solution

Conclusion In order to achieve a self-sustaining movement towards the adoption of item banking in Sweden, it is necessary to: involve multiple stakeholders at different levels in the early formulation of the approach, in order to build a sense of ownership.

Item bank project European/Nordic group meeting - Monday 16.00 Project management: Evalill Nilsson, QRC Stockholm evalill.nilsson@ki.se (project leader) John Chaplin, Gothenburg University john.chaplin@gu.se   Steering group: Staffan Lindblad (QRC Stockholm), Jack Lysholm (RCN), Anders Tennlind (RCSO), Thomas Troëng (RC Syd), Ulrika Frithiofsson (RC VGR) and Monica Sterner (UCR); representing each of the six Swedish RCs (Registry Centers) European/Nordic group meeting - Monday 16.00