Original research Development of an international standard set of patient-­centred outcome measures for overall paediatric health: a consensus process Beatrix Algurén ‍ ‍,1,2,3 Jessily P Ramirez,3 Matthew Salt,3 Nick Sillett,3 Stacie N Myers,3 Albie Alvarez-­Cote,3 Nancy J Butcher,4 Luiz F Caneo,5 Jaime A Cespedes,6 John E Chaplin,7 Kee Chong Ng,8 Juan J García-­García,9 Jan A Hazelzet,10 Anne F Klassen,11 Aida Luiza R Turquetto,5 Emma J Mew,12 Michael Morris,13,14 Martin Offringa,4 Matthew O’Meara,15 James M Papp,16 Carlos Rodrigo,17,18 Timothy L Switaj,19 Catalina Valencia Mayer,20 Kathy J Jenkins21 ►► Additional material is ABSTRACT published online only. To view What is already known on this topic? Objective To develop an Overall Pediatric Health please visit the journal online (http://​dx.​doi.​org/​10.​1136/​ Standard Set (OPH-­SS) of outcome measures that ►► Value-­based paediatric care needs health archdischild-​2020-​320345). captures what matters to young people and their families outcome measures that capture what matters and recognising the biopsychosocial aspects of health For numbered affiliations see to young people and their families. end of article. for all children and adolescents regardless of health ►► Comparable data on child development condition. irrespective of health condition are rare and not Correspondence to Design A modified Delphi process. always translatable across countries. Dr Beatrix Algurén, University of Setting The International Consortium for Health ►► There is a lack of an internationally accepted Gothenburg, Goteborg 405 30, Outcomes Measurement convened an international Sweden; ​beatrix.​alguren@​gu.​se standard set of outcome measures that Working Group (WG) comprised of 23 international recognise the biopsychosocial aspects of health Received 27 July 2020 experts from 12 countries in the field of paediatrics, for all children and adolescents. Revised 12 November 2020 family medicine, psychometrics as well as patient Accepted 14 November 2020 advisors. The WG participated in 11 video-­conferences, Published Online First 11 December 2020 through a modified Delphi process and 9 surveys between March 2018 and January 2020 consensus What this study adds? was reached on a final recommended health outcome standard set. By a literature review conducted in March ►► A consensus-­based standard set of 15 health 2018, 1136 articles were screened for clinician and outcome measures for all young people from patient-­reported or proxy-­reported outcomes. Further, birth to 24 years of age, measuring 22 domains 4315 clinical trials and 12 paediatric health surveys of physical, social and mental health. were scanned. Between November 2019 and January ►► Four developmental age-­specific packages 2020, the final standard set was endorsed by a patient made up of either five or six measures mainly validation (n=270) and a health professional (n=51) patient-­reported with average time of 20 min to survey. complete. ►► A starting point to drive value-­based paediatric Results From a total of 63 identified outcomes, consensus was formed on a standard set of outcome healthcare delivery from a global perspective. measures that comprises 10 patient-­reported outcomes, 5 clinician-­reported measures, and 6 case-­mix variables. matters most to young people and their families to The four developmental age-­specific packages (ie, 0–5, enable this.3 6–12, 13–17, 18–24 years) include either five or six Between March 2018 and January 2020, the measures with an average time for completion of 20 min. International Consortium for Health Outcomes Conclusions The OPH-­SS is a starting point to drive Measurement (ICHOM; www.​ichom.​org) value-­based paediatric healthcare delivery from a global convened a multidisciplinary Working Group (WG) perspective for enhancing child and adolescent physical to develop an Overall Pediatric Health Standard health and psychosocial well-­being. Set (OPH-­SS). The OPH-­SS comprises a minimum © Author(s) (or their set of outcome measures using internationally employer(s)) 2021. Re-­use permitted under CC BY-­NC. No accepted standardised measures for infants, chil- commercial re-­use. See rights dren and adolescents regardless of health condition. and permissions. Published INTRODUCTION Collecting and using this information consistently by BMJ. It is a core value of any paediatric healthcare service as a part of care delivery will position caregivers To cite: Algurén B, to ensure that when a child leaves their service, they to understand determinants of child and adoles- Ramirez JP, Salt M, et al. are as physically, mentally and socially healthy as cent well-­being in a comprehensive way, promoting Arch Dis Child possible.1 2 Value-­ based paediatric care (VBPC) person-­centred interventions and enhancing VBPC 2021;106:868–876. requires health outcome measures to capture what worldwide. Standardised and consistent outcomes 868   Algurén B, et al. Arch Dis Child 2021;106:868–876. doi:10.1136/archdischild-2020-320345 Original research assessment for all young people is likely to promote future outcomes were identified by categorising the extracted measures research and quality improvement collaborations, leading to from literature according to the topic/health outcome that they benchmarking within and across organisations, and between were considered to measure, for example, quality of life, devel- disease types. opment, mental health and communication (online supplemental eTable 3). Overall, a total of 63 health outcomes (partly overlap- METHODS ping) were identified (online supplemental eFigure 2 and eTables The overall paediatric health Working Group 4–7). Second, a total of 104 measures of the agreed-­upon health ICHOM established a WG of 23 international experts from eight outcomes for inclusion were systematically evaluated to meet high-­income countries, three upper-­middle-­income countries and ICHOM’s tool selection criteria, for example, available free one lower-­middle-­income country (online supplemental eTable of charge, available in English, validated and reliable (online 1). The WG included experts in Pediatrics, Family Medicine and supplemental eTables 8 and 9). Third, the contents of the eligible Instrument Development fields across various professional back- 26 tools were mapped to the consensus-­based final 22 outcomes grounds (eg, medical doctors, occupational and physical ther- covered by the OPH-­SS (eg, the PROMIS Pediatric Scale—Global apists). Additionally, two patient advisors (Australia and USA) health 7+2 is considered to measure quality of life, mood, who lead patient advocacy foundations were part of the WG. mobility, fitness, pain and sleep). Finally, the tools were packaged A Project Team (PT) guided the WG efforts and prepared the along with clinician-­reported measures and an ICHOM standard necessary materials. The project was launched in March 2018 measure of survival, to ensure the highest outcome coverage by using an iterative process of 11 WG videoconferences and subse- age range, using a minimum number of measures. Priority was quent rounds of electronic surveys (online supplemental eFigure given to continuity of instruments through the four OPH-­SS age 1). ranges and highest rates of outcome coverage (online supple- mental eTables 10–12). Identifying health outcomes, health outcome measures and Case-­mix variables identified by the literature review were case-mix variables extracted to enable meaningful comparisons of child and adoles- To identify potential health outcome and corresponding outcome cent health outcomes across treatment modalities and practices measures as well as case-­mix variables for risk adjustment, the (online supplemental eTable 13). PT reviewed the literature and more than 4000 registered paedi- atric clinical trials registered in the clinical trial database (​www.​ clinicaltrials.​gov) (online supplemental eFigure 1), 12 paediatric Modified Delphi and consensus process To reach consensus on health outcomes and outcome measures health surveys, and the Patient-­ Reported Outcome Measure- ment Information System (PROMIS) for outcome measures to be included in the OPH-­SS, a modified Delphi process was used in the paediatric population. The literature review was employed (online supplemental eFigure 1).4 5 To capture addi- performed in March 2018 comprising 1136 articles with 580 tional patient perspectives beyond the WG level, an online reviews (figure 1) (online supplemental eTable 2). First, health survey was trialled via hospital networks with 88 parents and caregivers in Mexico. Respondents were asked to rank the 63 identified health outcomes in accordance to the importance (on a 9-­point Likert Scale) for their child/children’s well-­being. This list was deemed to be comprehensive by 93% of parents/care- givers and the survey results were presented to WG prior to the first Delphi round to inform outcome selection. Following two voting rounds, only outcomes voted as ‘very important’ (ie, 7–9 points) by at least 80% of WG members were included. The outcomes that did not reach consensus were discussed during WG calls (2–4) in order to balance the request to develop a minimum but comprehensive standard set. In a third vote, the inconclusive outcomes were selected by a yes/ no vote with a 70% cut-­off for inclusion. This cut-­off applied to the selection of outcome measure packages, age range and case-­mix variables. The final OPH-­SS was approved by all WG members. Consumer open review Between November 2019 and January 2020, an electronic survey was sent to patients and professionals. While a sample of parents and caregivers of children and adolescents in Colombia, Singapore, the USA and the UK aged at least 18 years (online supplemental eTable 14) were asked to rank the importance of the preliminary OPH-­SS outcomes, paediatric and/or outcome measurement professionals were asked to indicate agreement or disagreement with: the age-­ranges defined by the OPH-­SS, the Figure 1 The flow-­diagram of the literature search, conducted in inclusion of each of the 22 outcomes, the selected measures per March 2018 (including peer-­reviewed articles from the last 10 years). outcome and age range and case-­mix-­variables. In both surveys, *Only reviews were included due to the otherwise tremendous amount respondents had the opportunity to leave additional free text of results (n=20 740 and n=12 751, respectively). comments. Algurén B, et al. Arch Dis Child 2021;106:868–876. doi:10.1136/archdischild-2020-320345 869 870 Table 1 Overview of the included health outcomes and instruments/tools for the specific ages with agreement from health professionals and parents Endorsed to be important by the Consumer Open Age-­ranges Review HP Parents* Age in years 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 (%) (%) Health outcomes included in OPH Standard Set for the specific age-­ranges as agreed on Original research Mental Cognition /intelligence √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 98 86 Mood √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 91 Mental Health √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 95 Coping √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 91 Self-­efficacy √ √ √ √ √ √ √ √ √ √ √ √ 86 Self-­esteem √ √ √ √ √ √ √ √ √ √ √ √ 90 Social Development √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 88 95 School Attendance √ √ √ √ √ √ √ √ √ √ √ √ √ 77 Communication √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 93 HRQoL √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 91 Social Functioning √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 92 Physical Eating √ √ √ √ √ √ 92 91 Hearing √ √ √ √ √ √ √ √ 88 Vision √ √ √ √ √ √ √ √ 99 Nutrition √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 91 Growth √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 88 Survival √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 88 Mobility √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 93 Pain-­free √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 89 Sleep √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 94 Fitness √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ 88 Sexual Health √ √ √ √ √ √ √ √ 76 Instruments and tools included in the OPH Standard Set in order to measure the agreed-­on specific health outcomes PROM C N CDC Milestone Checklist x x 10–29 Visual Acuity test—E-­Chart x N/A Visual Acuity test—Snellen-­Chart x N/A WHO Growth Charts—early years x 6 WHO Growth Charts—school age x 6 years School attendance x 1 ICHOM Standard Measure: Survival x 3 PROMIS Parent Proxy Scale—Global x 9 health PROMIS Parent Proxy short form— x 7 cognitive function Continued Algurén B, et al. Arch Dis Child 2021;106:868–876. doi:10.1136/archdischild-2020-320345 Table 1 Continued Endorsed to be important by the Consumer Open Age-­ranges Review HP Parents* Age in years 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 (%) (%) PROMIS Pediatric Scale—global x 9 health NIH Toolbox—self-­efficacy CAT x 10 PROMIS Short Form—sleep x 4 disturbance PROMIS Pool—sexual fct. and x 3 satisfaction-­screener PROMIS short form—cognitive x 4 Algurén B, et al. Arch Dis Child 2021;106:868–876. doi:10.1136/archdischild-2020-320345 function AQoL-­8D x 35 Total number of questions (n) within 20–39 25 31 49 age-­specific tool packages Time to complete (min) 30–41 24–30 26–32 13–23 Agreement with the age-­specific 94 98 96 94 toolset from HP (%) Information and definitions for all variables, data sources and recommended timeline for data collection is provided in the reference guide: https://connect.ichom.org/standard-sets/pediatric-overall-health/. *Parents and caregivers. √, included based on consensus, grey colour indicates that the respective health outcome is measured at this age, since it is measured by one of the instruments/tools that were agreed upon, and light grey colour indicates that the E-­chart can be used as alternative to the Snellen Chart depending on what works best for the child; AQoL-­8D, Assessment of Quality of Life-8 Dimensions; C, clinician reported; CDC, Centers for Disease Control and Prevention; HP, health professionals; HRQoL, health-­related quality of life; ICHOM, International Consortium for Health Outcomes Measurement; N, number of questions; N/A, not applicable; NIH, National Institutes of Health; PROMIS, Patient-­reported Outcomes Measurement Information System. Original research 871 Original research Table 2 Overview of the included outcomes, measures and case-­mix variables (n=6), age-­range specific Age ranges Outcome Measures Respondent 0–5 years Survival, HRQoL, sleep, pain, mobility, ICHOM Standard Measure: Survival Clinician development, communication, hearing, social CDC’s Developmental Milestones Checklist (available at: https://www.cdc.gov/ Clinicia and patient/proxy functioning, vision, growth, nutrition, school ncbddd/actearly/milestones/index.html) attendance Visual Acuity Test—E-­chart Clinician WHO Growth Chart (Early Years) (available at: https://www.who.int/childgrowth/ Clinician standards/en/) School attendance Patient/proxy 6–12 Survival, HRQoL, sleep, pain, mobility, ICHOM Standard Measure: Survival Clinician years development communication, social PROMIS Parent Proxy Scale V.1.0—Global Health 7+2 (available at: www. Patient/proxy functioning, vision, growth, nutrition, school healthmeasures.net) attendance, cognition/intelligence, mood, mental health, coping, fitness Visual Acuity Test—Snellen-­chart (E-­chart where Snellen cannot be used) Clinician WHO Growth Chart (School-­Age Years) (available at: https://www.who.int/ Clinician childgrowth/standards/en/) School attendance Patient/proxy PROMIS Parent Proxy Scale V.1.0—Cognitive Function 7a (available at: www. healthmeasures.net) 13–17 years Survival, HRQoL, sleep, pain, mobility, ICHOM Standard Measure: Survival Clinician development, communication, social WHO Growth Chart (School-­Age Years) (available at: https://www.who.int/ Clinician functioning, growth, nutrition, school childgrowth/standards/en/) attendance, cognition/intelligence, mood, mental health, coping, fitness, self-­esteem, School attendance Patient self-­efficacy PROMIS Parent Proxy Scale V.1.0—Cognitive Function 7a (available at: www. Patient/proxy healthmeasures.net) PROMIS Pediatric Scale V.1.0—Global Health 7+2 (available at: www. Patient healthmeasures.net) NIH Toolbox—Self-­Efficacy CAT Ages 13–17 V.2.0 (available at: www. Patient healthmeasures.net) Patient 18–24 Survival, HRQoL, sleep, pain, mobility, ICHOM Standard Measure: Survival Clinician years communication, social functioning, vision, PROMIS Short Form V.1.0—Sleep Disturbance 4a (available at: www. Patient hearing cognition/intelligence, mood, mental healthmeasures.net) health, coping, fitness, self-­esteem, self-­ efficacy PROMIS Pool V.2.0—Sexual Function and Satisfaction: Screeners (available at: www. Patient healthmeasures.net) PROMIS Short Form V.2.0—Cognitive Function 4a (available at: www. Patient healthmeasures.net) AQoL-­8D (available at: http://www.aqol.com.au/choice-of-aqol-instrument/58.html) Patient Case-­mix variable     Age Patient year and month of birth. In what year and month were you born? RESPONSE: Patient/administrative (ICHOM Standard Measure: Age) MM/YYYY Sex Biological sex of patient at birth. Please indicate your biological sex at birth. Patient/administrative (ICHOM Standard Measure) RESPONSE: male/female/unknown Diagnosis Prior and current diagnosis of disease or no presence of diagnosis. Please list any Clinician (International Statistical Classification of Diseases and Related prior and current conditions. Health Problems (ICD)) RESPONSE: ICD-10 or SNOMED-­CT/None Parent education level Please list highest level of education of either parent. Patient and/or primary caregiver (ICHOM Standard Measure: Education (as defined by ISCED RESPONSE: None/Primary/Secondary/Tertiary schooling levels)/Proxy measure for socioeconomic status on other ICHOM sets. Primary caregiver Please state the primary caregiver (check all that apply). Patient and/or primary caregiver (Non-­standard measure) RESPONSE: Mother or Father/Other family member/Self/Other Respondent Who is providing this information about the patient? Patient and/or primary caregiver (Non-­standard measure) RESPONSE: Mother or Father/Other family member/Self/Other These case-­mix variables are recommended for all children, with an expectation that additional variables may need to be collected to allow context-­specific benchmarking in some settings during implementation. AQoL-­8D, Assessment of Quality of Life-8 Dimensions; CDC, Centers for Disease Control and Prevention; ICHOM, International Consortium for Health Outcomes Measurement; PROMIS, Patient-­ reported Outcomes Measurement Information System. Ethical considerations The OPH-SS: health outcomes and measures For the patient validation survey, an institutional review board Through the modified Delphi process, consensus was reached to (IRB) exemption review was obtained for each country (online include 22 outcomes in the standard set ranging across the whole supplemental eTable14). spectrum of biopsychosocial health (table 1) and are measured by 15 different tools (table 2): RESULTS ►► Five measures that are clinician-­reported and often collected In response to the latest debate on arbitrary age limits in routinely in clinical practice: WHO Growth Charts—Early paediatric care, which encourages including young adulthood, Years and School—Age Years versions, Visual Acuity Test—E-­- consensus was reached to include health outcome measures for chart and Snellen-­chart, Survival. newborns through 24 years of age (75%).6–8 ►► Nine measures that are patient-/parent-/proxy-­reported. 872 Algurén B, et al. Arch Dis Child 2021;106:868–876. doi:10.1136/archdischild-2020-320345 Original research Figure 2 Proposed timeline for collecting baseline, outcome and case-­mix variables for each of the four specific developmental stage subsets. ►► One that is both parent/proxy and clinician-­ reported, the parent education level and primary caregiver and respondent Centers for Disease Control and Prevention Developmental (table 2). Since, several proxy-­reported measures are included in Milestone Checklist. the standard set, a sixth variable confirming the respondent (eg, The recommended age-­group specific tool packages comprise mother/father, other family members, self, others) was included. between 5 and 6 instruments/measures, with 24–49 questions, taking between 15 and 40 min to complete. Consumer open review Timepoints (in years) and frequency of measurements Parents and professionals’ perspectives At a minimum, measurements should be taken at the point of A total of 270 parents or caregivers of children and adolescents transition between developmental stages as defined by on the participated in a survey. Most respondents had one child (41%) National Institute of Child Health and Human Development followed by two and three children (36% and 17%, respectively) Pediatric Terminology9 (ages 6, 12, 18, 21 and where appro- with an equal sex distribution, representing the whole age-­range priate, age 24) (figure 2). The WG recommends optional annual covered by the OPH-­SS (online supplemental eTable 15). At least measurements up to 5 years of age due to rapid development 86% of respondents ranked 20 of the 22 outcomes as important, and then at ages 9 and 15 years. Since child and adolescent with slightly fewer (76%) also deeming school attendance and development varies independently of age, the use of the selected sexual health as important (table 1). Almost all respondents measures lends flexibility to an individual’s development.9 For (94%) agreed that this list captured all the important outcomes example, if an adolescent is sexually active before the age of 18 that matter most for paediatric patients. years, a clinician could use the PROMIS Pool v2.0- Sexual Func- In a concurrent survey of paediatrics health professionals tion and Satisfaction—Screener earlier than the age of 18 years. from 14 countries (n=51) (online supplemental eTable 16), at least 88% or more of the respondents agreed with the proposed Case-mix variables outcomes and case-­mix variables (98% for mental and 92% for From a set of 30 case-­mix variables identified (online supple- physical functioning) and over 94% agreed with the recom- mental eTable 13), 5 variables were included: age, sex, diagnosis, mended measurements for each OPH-­SS age-­range (table 1). Algurén B, et al. Arch Dis Child 2021;106:868–876. doi:10.1136/archdischild-2020-320345 873 Original research Table 3 Comments from respondents of the consumer open review survey who did not agree that the OPH-­SS is complete with comments from the Working Group Included in Parents Professionals OPH-­SS (Yes/ Examples of specific questions (6% did not agree) (2%–12% did not agree)* No) Answers from the Working Group contained in the included tools Outcomes Screen time No There is no standardised way to measure it yet General happiness; joy Yes Included in PROMIS-­General Health and How often do you feel really sad? AQoL-­8D How often do you have fun with friends? How often do you feel happy? How often do you feel pleasure? Accessibility to quality healthcare No No outcome. It could be uptaken as a case-­mix variable, but hard to measure in a standardised way worldwide. Social interaction with peers and Social interactions with family, peers Yes Included in PROMIS-­General Health and How often do you feel socially excluded parents; social well-­being; social and adults should be defined by its AQoL-­8D. or left out? environment in family and with own outcome separately from general We tried to reduce the amount of tools and How often do you have fun with friends? friends functioning and development. questions to answer in order to increase How often do your parents listen to your the uptake and feasibility of the OPH-­SS. ideas? Therefore, it is not measured by a specific social Does your health affect your relationship interaction instrument. with your family? How satisfying are your close relationships (family and friends)? How much do you enjoy your close relationships (family and friends)? How often do you feel socially isolated? Treatment in school No Not qualified to be included in a minimum set of health outcomes Bullying Yes (?) It might be detected by questions in PROMIS-­ How often do you feel socially excluded General Health and AQoL-­8D or left out? How often do you have fun with friends? How often do you feel socially isolated? Fine motor skills Yes Measured by CDC’s Developmental Milestones Makes or copies straight lines and circles; Checklist. Pours, cuts with supervision, and mashes own food; Uses a fork and spoon and sometimes a table knife Lifestyle factors, including addictions, No Not qualified to be included in a minimum set should be included in the older age of health outcomes ranges. Hearing should be assessed for all age Yes/No It is not measured by any tool only for one age ranges. range between 13 and 17 years. Case-­mix Health problems/medical condition/ Yes Measured by Case-­mix variable 'Diagnosis' ICD-10 or Snomed-­CT disease specifics Genetics No Not feasible to measure worldwide, ethical aspects have to be considered Home environment in terms of parents No Not qualified to be included in a minimum set and access to food, healthcare and of health outcomes sanitation.   Presence of complications during No Not qualified to be included in a minimum set   pregnancy as well as prematurity of of health outcomes the infant *For more information about agreement of completeness from health professionals, see table 1. AQoL-­8D, Assessment of Quality of Life-8 Dimensions; OPH-­SS, Overall Pediatric Health Standard Set; PROMIS, Patient-­Reported Outcome Measurement Information System. Comments from both parents and professionals who did not healthcare should be ‘patient-­centred’ and put ‘each patient agree are presented in table 3 with comments from the WG. in control of his or her own care’.10 Therefore, the OPH-­S S is recommended for routine use in clinical practice to assess Reference guide health outcomes and facilitate and empower young people and In order to facilitate the adoption and implementation of the parents to make shared decisions about their care, with their OPH-­SS, a reference guide was developed by ICHOM (https://​ caregivers.11 12 connect. ​ i chom. ​ o rg/ ​ s tandard- ​ s ets/ ​ p ediatric- ​ o verall- ​ h ealth/). To allow meaningful comparisons across different settings and It provides information and definitions for all variables, data countries, six case-­mix variables addressing demographic, clin- sources and a recommended timeline for data collection. ical and parental (or primary caregiver) risk factors are included. This is a multidisciplinary standard set of paediatric outcome DISCUSSION measurements developed to measure the overall biopsychoso- The OPH-­S S comprises 10 PROMs and 5 clinician-­reported cial health and the well-­being of anyone up to 24 years of age.8 validated and reliable measures, using between 5 and 6 All measures are free of licensing fees and most are available in measurements for each of the four developmental age-­stages, multiple languages to reduce barriers to uptake of the standard with an average completion time of 20 min. Ultimately, set internationally. 874 Algurén B, et al. Arch Dis Child 2021;106:868–876. doi:10.1136/archdischild-2020-320345 Original research 5 For the OPH-­ SS to drive VBPC, widespread implementa- Heart Institute, University of Sao Paulo Medical School, Sao Paulo, Brazil 6 tion strategies to incorporate measures in routine clinical prac- Fundacion Cardioinfantil- Instituto de Cardiologia, Universidad del Rosario, Bogota, Colombia tice and existing workflows throughout various paediatric care 7 Department of Pediatrics, Institute of Clinical Sciences, University of Gothenburg, settings will be critical. Meaningful, relevant and actionable Göteborg, Sweden comparative benchmarking practices need to be developed and 8 KK Women & Children’s Hospital, Singapore 9 refined. Implementation and adoption should allow healthcare Hospital Sant Joan de Déu, Barcelona, Spain 10 comparison across different settings and countries to facilitating Department of Public Health, Erasmus Medical Centre, Rotterdam, The Netherlands 11 Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada local and global improvements in paediatric care delivery and 12 Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, promoting international cross-­cultural paediatric research. Toronto, Ontario, Canada 13 Samuel Morris Foundation, Sydney, New South Wales, Australia 14 Sydney Children’s Hospital Networks, Sydney, New South Wales, Australia Limitations 15 NSW Health, Sydney, New South Wales, Australia In order to minimise the burden of documentation and time to 16 Mindful Metrics, LLC, Cincinnati, Ohio, USA completion, the recommended measures cover several outcomes 17 Pediatrics, Germans Trias i Pujol University Hospital, Badalona, Catalunya, Spain 18 and comprise a minimum set of questions. The WG aimed to strike Universitat Autònoma de Barcelona Facultat de Medicina, Bellaterra, Catalunya, a balance between measuring each outcome using a specific instru- Spain 19 U.S. Army, Boston, Massachusetts, USA ment and risking double documentation or including instruments 20 Fundación CINDA - Universidad El Bosque, Bogotá, Colombia that measure broader concepts covering a variety of outcomes. 21 Boston Children’s Hospital, Boston, Massachusetts, USA Sum scores can be calculated for the included broader concepts (eg, quality of life, self-­efficacy). While the global implementation Twitter Nancy J Butcher @NancyJButcher, Jan A Hazelzet @janhazelzet, Anne F of the OPH-­SS allows further psychometric testing of the included Klassen @anneklassen and Carlos Rodrigo @crodrigogl measures for various populations, more comprehensive measures Acknowledgements We would like to thank all WG members, patient may be needed to increase validity and sensitivity for specific representatives and professionals, for their time and effort developing this OPH-­SS important outcomes. The feasibility of implementing the OPH-­SS without financial remuneration. may vary between different countries and healthcare systems. As Contributors BA, as a member of the Project Team performed the literature search a result of varying technological access, representation from low-­ and analysis, prepared materials for the consensus process, drafted the manuscript and finalised it in collaboration with all authors. JR, MS, NS and SM as members of income countries could not be included during the consensus the Project Team performed analysis, prepared materials for the consensus process, process diminished as the WG process progressed. The ICHOM revised the manuscript and approved the final version prior to submission. KJ, as process is iterative and a Steering Committee, comprised of former Working Group Chair and member of the Project Team led the group by promoting WG members, will serve as a stewarding body to ensure that the the vision for the project and guiding the consensus building process, revised the manuscript and approved the final version prior to submission. AA-­C, NB, LC, JaC, OPH-­SS remains up to date with the most current evidence and is JoC, NKC, JJG-­G, JH, AK, ALRT, EM, MM, MO, MO’M, JP, CRGdL, TS, CV, as members revised in line with feedback received from implementation expe- of the working group participated in discussions and consensus process, revised the riences across communities. manuscript and approved the final version prior to submission. Funding The development of this standard set was made possible by the generous CONCLUSION contributions from the following sponsors: NSW Agency for Clinical Innovation, Based on an extensive literature review, assessment of clinical trials Boston Children’s Hospital, Erasmus Medical Center (Sophia Children’s Hospital), KK Women and Children’s Hospital, Cincinnati Children’s Hospital Medical Center, and registries, international patient input and paediatric expert Health Service Executive, Meyer Children’s Hospital, Hospital Sant Joan de Déu, The consensus, a minimal set of 15 health outcome measures was devel- Hospital for Sick Children and Fundación Cardioinfantil—Instituto de Cardiología. oped. To our knowledge, this is the first set of paediatric outcome Disclaimer The views expressed herein are those of the author (TLS) and do not measurements not specific to any health condition but applicable reflect the official policy or positon of Brooke Army Medical Center, the U.S. Army to the overall biopsychosocial health and well-­being of any infant, Medical Department, the U.S. Army Office of the Surgeon General, the Department of child or adolescent throughout all developmental stages from birth the Army, the Department of the Air Force, or the Department of Defense, or the U.S. Government to 24 years of age. With the implementation of this set in daily clin- ical practice worldwide, care delivery teams should be increasingly Competing interests JEC is a Swedish national representative for the PROMIS Health Organisation and DISABKIDS Quality-­of-­Life measurement system. accountable to promote well-­being of individuals, with a subsequent understanding of the quality of care being delivered. Comprehensive Patient consent for publication Not required. evaluation of outcomes and discussion of the results with patients Provenance and peer review Not commissioned; externally peer reviewed. and parents will facilitate shared decision-­making between fami- Data availability statement All data relevant to the study are included in the lies and their healthcare providers. Health literacy will also likely article or uploaded as supplementary information. Not applicable. improve, ensuring that families will be sufficiently knowledgeable Supplemental material This content has been supplied by the author(s). It about the healthcare they receive, ultimately resulting in more equi- has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have table care delivery, globally. The next steps will be to implement the been peer-­reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and OPH-­SS in the current clinical workflow, harmonising data collec- responsibility arising from any reliance placed on the content. Where the content tion with electronic health records and registries and developing includes any translated material, BMJ does not warrant the accuracy and reliability strategies to provide the data back to clinical teams and patients, of the translations (including but not limited to local regulations, clinical guidelines, creating a meaningful process to drive value-­based healthcare. terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise. Author affiliations Open access This is an open access article distributed in accordance with the 1 Department of Food and Nutrition, and Sport Science, Faculty of Education, Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which University of Gothenburg, Göteborg, Sweden permits others to distribute, remix, adapt, build upon this work non-­commercially, 2 Jönköping Academy for Improvement of Health and Welfare, School of Health and license their derivative works on different terms, provided the original work is Sciences, Jönköping University, Jönköping, Sweden properly cited, appropriate credit is given, any changes made indicated, and the use 3 International Consortium for Health Outcomes Measurements (ICHOM), Boston, is non-­commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/. Massachusetts, USA 4 Child Health Evaluative Sciences, Hospital for Sick Children, University of Toronto, ORCID iD Toronto, Ontario, Canada Beatrix Algurén http://​orcid.​org/​0000-​0001-​9993-​8741 Algurén B, et al. Arch Dis Child 2021;106:868–876. doi:10.1136/archdischild-2020-320345 875 Original research REFERENCES 6 Hardin AP, Hackell JM, Committee on practice and ambulatory medicine. Age limit of 1 Flanagan P, Tigue PM, Perrin J. The value proposition for pediatric care. JAMA Pediatr pediatrics. Pediatrics 2017;140:e20172151. 2019;173:1125–6. 7 Sawyer SM, Azzopardi PS, Wickremarathne D, et al. The age of adolescence. Lancet 2 Chua K-­P, Conti RM, Freed GL. Appropriately framing child health care spending: a Child Adolesc Health 2018;2:223–8. 8 Sawyer SM, McNeil R, Francis KL, et al. The age of paediatrics. Lancet Child Adolesc prerequisite for value improvement. JAMA 2018;319:1087–8. Health 2019;3:822–30. 3 Bae J-­M. Value-­Based medicine: concepts and application. 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ARCHIVIST Physical restraint for children who have behavioural health related issues The Archivist has never supported physically restraining angry or violent and emotionally charged children in the emergency department or on the ward. Unfortunately there may be situations where it is felt the only option. Many units will have a physical or chemical restraint guidelines which always causes controversy and most clinicians and nurses, when discussing options with the parents and trying to engage the child, do not find it easy to instigate. Dalton E M et al (Pediatrics 2021;148:e2020003939) have tackled this issue and provide some excellent advice and suggestions on how to prevent the need for restraint. Children with primary behavioural health conditions are presenting to children’s hospitals with increasing frequency and can be a major challenge in the inpatient environment. There may well be no immediate child psychiatric bed available so they are admitted to a paediatric ward while awaiting psychiatric assessment and admission to the psychiatric unit. The ward staff has to balance the safety of the children and the hospital staff while trying to de-­escalate the situation. If there is a high risk of self-­harm or injury to staff members or other children and families then the child or young adult can be placed in physical restraints to reduce the risk of violence to themselves and others. This group used quality improvement methodology to decrease physical restraint use on children admitted to their chil- dren’s hospital for behavioural health conditions They included all children over 3 years of age who had been admitted to their hospital medicine service with a primary behavioural health diag- nosis from 1 July 2016, to 1 February 1 2020. The cohort included 3962 consecutive behavioural health patient encounters, encompassing a total of 9758 patient days. They formed a multidisci- plinary team, in July 2018, tested interventions based on key drivers targeted toward their aim. A 2 year baseline revealed physical restraint orders placed on 2.6% of behavioural health patient days, which was decreased to 0.9% after interventions and has been sustained over 19 months without any change in staff injuries. Their driver diagram illustrates the six core strategies in this bundle. They used a standardised de-­escalation protocol based on the Brøset Violence Checklist (Brøset) which is a 6-­item checklist used to assess the presence of 6 independent behaviours to help predict the risk of imminent violent behaviour over the following 24 hours. This was one of the Six Core Strategies of restraint reduction which was their overall strategy; an improved de-­es- calation protocol using the Brøset scoring, introduction of a behavioural health admission policy, the creation of a multi-­disciplinary behavioural team and they restructured the behavioural health team staff meetings, they created individualised health treatment plans and an updated their toy and activity reward system. So using this team-­based quality improvement methodology there was a sustained reduction in physical restraint use on children admitted for behavioural health conditions. Physical restraint use can be safely reduced. Is it a potential problem on your wards? Provenance and peer review Commissioned; internally peer reviewed. © Author(s) (or their employer(s)) 2021. No commercial re-­use. See rights and permissions. Published by BMJ. Accepted 19 July 2021 Published Online First 22 July 2021 Arch Dis Child 2021;106:876. doi:10.1136/archdischild-2021-322872 876 Algurén B, et al. Arch Dis Child 2021;106:868–876. doi:10.1136/archdischild-2020-320345