CENTRE CONDUCTING THE REVIEW. New South Wales Centre for Evidence Based Health Care

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1 Factorsdeterminingdiabetescareoutcomesinpatientswith type1diabetesaftertransitionfrompaediatrictoadult healthcare:asystematicreview Protocol CENTRECONDUCTINGTHEREVIEW New South Wales Centre for Evidence Based Health Care Primary reviewer/contact Name: Kaye Farrell Phone: (02) Fax: (02) Secondary reviewers: Name: Rhonda Griffiths Phone: (02) Fax: (02) Name: Ritin Fernandez Phone: (02) Fax: (02) Name: Marlene Payk Phone: (02) Fax: (02)

2 Name: Jane Payne Phone: (02) Fax: (02) Commencement date: July 2009 Expected completion date: December 2009

3 Background Health care delivery to people with diabetes has traditionally been within two distinct paradigms - either the paediatric or adult health service 1. Psychology researchers now recognise the unique developmental stage of the young person immediately post high school as distinct from the young adult period, which was traditionally said to begin after adolescence but is now thought to begin in the late twenties or early thirties 2. It is during this post adolescent phase that most young people with diabetes are transitioned to adult care, and at a time when they have competing demands of diabetes management and the chaotic life style of their peers, making them vulnerable to acute diabetes complications such as diabetic ketoacidosis or severe recurrent hypoglycaemia 1. Also during this phase receptiveness to change is limited and as a means to asserting independence the young adult will reject adult control and adult authority figures 2. It has been suggested 3 that the adult health system is less attuned to the developmental and behavioural struggles of the young adult and this may be unsettling for both them and their family. A disorganised transfer from paediatric health services to adult care may lead to loss to follow up, which increases risk of developing diabetes complications 4. There have been few published randomised control trials (RCT) addressing the transition of adolescents and young adults with type 1 diabetes from paediatric to adult health care, so meaningful conclusions about factors determining the success of transition are limited 5. The current models of care for adolescents focus on importance of paediatric support while still at school, when the majority of young people will still be supported and influenced by family. As a consequence young people who leave school early eg to undertake trade apprenticeships at age will often be transitioned to adult services at a time when there are multiple changes to routine, when they have already been exposed to a number of adult influences outside of family and are not linked to adult health care providers. 6 Historically paediatric health care professionals have found it difficult in transferring patients into adult care due to legitimate concerns of appropriate available services 7.The Australian Clinical Practice Guidelines: Type 1 diabetes in Children and Adolescents 8 recommends that transition take place between the age of 16 and 18 years but current practice is to transition young people at completion of schooling or after turning18. A later age of transition may not

4 be the ideal time for transition to occur given a number of major adolescent developmental changes occurring at this stage 2 and the demands of study, work and relationships which compete with the young adult s commitment to diabetes management 6. General consensus is that transition should not be concurrent with a medical crisis 9, however this is occurring with increased frequency as admission to paediatric health care facilities is being denied on the basis of age. Anderson 10 has suggested that the transition period provides a window of opportunity to promote and support adult self-care behaviours which is frequently lost as young adults (18 22yrs) are distracted by the priorities of study, financial self support and social demands. Research Question: What factors determine diabetes care outcomes for young adults with type 1 diabetes after transition from paediatric to adult health care services? Criteria for considering studies for this review: Types of studies All randomised, quasi randomised controlled trials, clustered trials, descriptive studies, prepost test studies, other designs with a control group and case studies evaluating factors which influence the transition from paediatric to adult health care of patients with type 1 diabetes, will be included in the review. Studies involving participants who have not transferred to adult care, are older than 19 years( as traditionally transition occurs around 18years of age) and people with type 2 diabetes will be excluded. Types of participants People aged years inclusive with diagnosis of type 1 diabetes who have been transitioned from paediatric to adult health care services. Types of outcome measures The primary outcomes are: 1. Diabetes control as measured by HbA1c at follow-up 2. Loss to follow-up 3. Adherence to insulin therapy 4. Incidence of hospital admission for acute complications 5. Frequency and regularity of clinic attendance

5 Secondary outcomes: 1. Uptake of screening for long term diabetes complications 2. Cost effectiveness of intervention 3. Health related quality of life 4. Patient satisfaction Searchstrategyforidentificationofstudies Prior to commencing the review a search of the Cochrane Collaboration, and The Joanna Briggs Institute will be completed to ensure that a systematic review on this subject is not being undertaken. The search will seek to identify both published and unpublished trials. In consultation with a librarian, databases will be searched to identify key words used in the titles and abstracts as well as subject listings, such as MeSH terms. As each database has its own indexing terms, individual search strategies will be developed for each database. During the development of the search strategy, consideration will be given to the diverse terminology used and the spelling of keywords as this would influence the identification of relevant trials. Examples search strategies can be found in Appendix I. In addition the reference lists of all identified articles and reports will be searched for other articles which may be considered for data collection based on their titles. A search for unpublished studies and relevant conference abstracts will be conducted across appropriate sources. Hand searching of conference proceedings, theses and any other relevant articles will also be undertaken. Key researchers and company representatives will be contacted to identify any further trials or research in progress. Databases to be searched include: CINAHL MEDLINE PsycInfo EMBASE BioMed Central Current Controlled Trials ISI Web of Knowledge

6 The search for unpublished studies or grey literature will include: MEDNAR OpenSigle Proquest Dissertations and Theses Index to Theses Networked Digital Library of Theses and Dissertations ProceedingsFirst New York Academy of Medicine s Grey Literature Report Methods of the review Two reviewers will independently assess the titles and abstracts identified from the search against the inclusion/exclusion criteria (Appendix II). If, in any study, the title and abstract are inconclusive full text will be obtained for further assessment. Full text copies of articles, which are identified as meeting the inclusion criteria, will be obtained for critical appraisal and data synthesis. All references will be entered into the bibliographic software program Endnote Version 11. Studies that have been reported in more than one publication will be included only once. Reviewers will jointly determine articles to be included. Assessment of methodological quality The methodological quality of the eligible trials will be assessed independently by two reviewers using the Joanna Briggs Institute (JBI) quality assessment tool for experimental studies (Appendix III). Any disagreements will be resolved by discussion with a third person. Each study will be critically appraised and methodological quality will be assessed using the following checklist: 1. detailed description of the inclusion and exclusion criteria used to obtain the sample 2. evidence of allocation concealment at randomisation if appropriate. 3. the validity of methods of outcome assessment 4. description of withdrawals and dropouts 5. the potential of bias in outcome measures Data extraction Data extraction from the included trials will be undertaken and summarised independently by two reviewers using a data extraction tool (Appendix IV). The data extraction tool will be piloted by two independent reviewers prior to use. Discrepancies between reviewers will be resolved by discussion. Data will be collected relating to: patient demographics patient inclusion/exclusion criteria

7 description of the factors identified as influencing transition age at transition description of outcomes the number and reasons for withdrawal and dropouts If any data are missing from the trial report, attempts will be made to obtain them by contacting the authors. Data synthesis Where possible RCT results will be pooled in statistical meta-analysis and all calculations will be made using the Cochrane statistical Review Manager (RevMan) version 5. Clinical heterogeneity will be assessed by considering the populations, interventions and outcomes between the studies. Statistical heterogeneity will be investigated by calculating the I 2 statistic, and if this indicates a high level of heterogeneity among the trials included in the analysis, a random effects metaanalysis will be preferred for an overall summary. Where high levels of heterogeneity are found in trials sensitivity analysis will be used to exclude studies deemed susceptible to bias, which may occur when there is inappropriate allocation concealment, high dropout levels post randomisation or unblinded outcomes assessment. Where studies are deemed similar a fixed effects meta-analysis will be used. Odds ratio (for categorical data) and weighed mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Studies with textural data results or where synthesis is inappropriate will be presented as a narrative summary. Potential conflict of interest: None

8 References 1. Weissberg - Benchell J, Wolpert H, Anderson BJ. Transitioning From Pediatric to Adult Care. A new approach to the post-adolescent young person with type 1 diabetes. Diabetes Care. 2007;30(10): Arnett JJ. Emerging adulthood: a theory of development from the late teens through the twenties. American Psychology. [Journal]. 2000;55: Sawyer SM, Blair S, Bowes G. Chronic illness in adolescents: transfer or transition to adult services? J Paediatric Child Health. 1997;33: Kipps S, Bahu T, Ong K, Ackland FM, Brown RS, Fox CT, et al. Current methods of transfer of young people with Type 1 diabetes to adult services. Diabetic Medicine. 2002;19: Holmes-Walker DJ, Llewellyn A, Farrell K. A transition care programme which improves diabetes control and reduces hospital admission rates in young adults with Type 1 diabetes aged years. Diabetic Medicine. 2007;24: Reiss J, Gibson R. Health care transitions: destinations unknown. Pediatrics. 2002;110: Hauser ES, Dorn L. Transitioning adolescents with sickle cell disease to adultcentered care. Pediatric Nursing. 1999;25: NHMRC. Australian Clinical Practice Guidelines: Type 1 diabetes in children and adolescents p Freed GL, Hudson EJ. Transitioning children with chronic disease to adult care:current knowledge, practices and directions. The Journal of Pediatrics. 2006;146: Anderson BJ. Families and Chronic Illness Research: Targeting Transition and Tools - Commentary on Trief et al. (2006). Families, Systems, & Health. 2006;24(3):332-5.

9 APPENDIX I SEARCH STRATEGIES Medline (OVID) Search Strategy 1. Diabetes Mellitus, Type 1/ or type 1 diabetes.mp. 2. limit 1 to "adolescent (13 to 18 years)" 3. Outpatients/ 4. "Delivery of Health Care"/ 5. Social Support/ 6. Financial Support/ 7. self care/ or blood glucose self-monitoring/ or self administration/ or self medication/ 8. Health Knowledge, Attitudes, Practice/ 9. Adaptation, Psychological/ or Stress, Psychological/ 10. developmental changes.mp. 11. "delivery of health care"/ or "delivery of health care, integrated"/ or health services accessibility/ 12. communication barriers/ or interdisciplinary communication/ 13. age factors/ and health transition/ or 10 or 6 or 11 or 13 or 7 or 3 or 9 or 12 or Hemoglobin A, Glycosylated/ or diabetes control.mp. 16. Patient Dropouts/ 17. loss to follow-up.mp or hospitalization/ or "length of stay"/ or patient admission/ or patient readmission/ 20. "patient acceptance of health care"/ or patient participation/ 21. Patient Compliance/ 22. Diabetic Ketoacidosis/ 23. Diabetes Complications/ or 20 or 23 or 22 or 18 or 15 or and 2 and transition or transfer$. mp and 26

10 EMBASE (OVID) Search Strategy 1. Insulin Dependent Diabetes Mellitus/ 2. limit 1 to adolescent <13 to 17 years> 3. interpersonal communication/ or nonverbal communication/ or verbal communication/ 4. self care/ or psychosocial care/ or social support/ 5. diabetes education/ 6. doctor patient relation/ or outpatient care/ 7. 3 or 4 or 5 or 6 8. diabetes control/ 9. clinic attendance.mp. 10. loss to follow-up.mp. 11. Hospital Admission/ 12. Diabetic Ketoacidosis/ 13. Diabetic Nephropathy/ or Diabetic Retinopathy/ or diabetes complication screening rates.mp. 14. patient compliance/ or 13or 12 or 11 or 10 or 9 or and and transition.mp and 17

11 CINAHL (EBSCO) Search Strategy 1 MH "Diabetes Mellitus, Insulin-Dependent" 2 outpatient service or ambulatory care 3 health care delivery 4 social support or financial support 5 health knowledge or attitudes 6 MH "Stress, Psychological" 7 adaptation, psychological" or MH "Adaptation" or MH " Psychological 8 MH "Behavioral Changes" 9 MH "Communication Barriers" 10 MH "Communication Barriers" or interdisciplinary communication 11 "self care behaviors" 12 S2 or S3 or S4 or S5 or S6 or S8 or S9 or S10 or S11 13 MH "Hemoglobin A, Glycosylated" 14 patient dropouts 15 MH "After Care" 16 MH "Diabetic Ketoacidosis" 17 "hospital admission" 18 "patient participation" 19 MH "Medication Compliance" or MH "Patient Compliance 20 "diabetes complication screening" 21 "diabetes complication screening" or long term diabetes complications 22 S13 or S14 or S15 or S16 or S17 or S18 or S19 or S20 or S21 23 transition or transfer to adult health care 24 transition or transfer from pediatric or paediatric to adult health care or transitional care 25 S23 or S24 26 S12 and S22 27 MH "Adolescence" 28 S25 and S1 and S26 and S27

12 PsychINFO (OVID) Search Strategy 1. type 1 diabetes.mp. 2. limit 1 to 200 adolescence 3. treatment/ or "medical treatment (general)"/ 4. exp Health Care Delivery/ or outpatient service.mp. 5. ambulatory care.mp. 6. exp Social Support/ 7. parental involvement/ 8. emotional adjustment/ or adjustment/ 9. exp Psychological Stress/ 10. health knowledge/ 11. adolescent development/ or psychological development/ or 11 or 3 or 7 or 9 or 8 or 4 or 10 or continuity of patient care.mp. 14. exp Communication Barriers/ or communication.mp. 15. exp Treatment Dropouts/ 16. treatment outcomes/ or 13 or 15 or transition or transfer from pediatric or paediatric to adult health care.mp and 12 and 2

13 APPENDIX II - VERIFICATION OF STUDY ELIGILIBILLITY Factorsinfluencingdiabetescareoutcomesinpatientswithtype1diabetesaftertransitionfrom paediatrictoadulthealthcare:asystematicreview VERIFICATION OF STUDY ELIGILIBILLITY AUTHOR AND YEAR: JOURNAL: TITLE: INCLUSION CRITERIA Study Design: Randomised control trial Yes No Clustered trial Yes No Descriptive study Yes No Pre-post test study Yes No Case control study Yes No Case study Yes No Subjects: Human Yes No Setting: Hospital Yes No Community Yes No Intervention: Does the study describe an intervention or narrative summary of outcomes Yes No Outcome: Does the study evaluate the effect of the intervention or describe the outcome measures on Diabetes control as measured by HbA1c Yes No Loss to follow-up Yes No Adherence to therapy Yes No Incidence of hospital admission Yes No (for acute complications) Clinic attendance rates Yes No Uptake of screening Yes No (for long term diabetes complications) You should answer YES to at least 1 question in ALL the above groups. If not please do not complete the remaining forms.

14 APPENDIX III JBI CRITICAL APPRAISAL CHECKLIST FOR EXPERIMENTAL STUDIES Randomised Controlled Trials Factorsinfluencingdiabetescareoutcomesinpatientswithtype1diabetesaftertransitionfrom paediatrictoadulthealthcare:asystematicreview Reviewer Author Date Year RecordNumber Yes (1) No (0) Unclear(0) 1. Were the participants randomised to study groups? 2. Were the participants blinded to treatment allocation? 3. Was allocation to treatment groups concealed from the allocator? 4. Were those assessing outcomes blind to the treatment allocation? 5. Were the groups comparable at entry? 6. Other than research intervention were groups treated identically? 7. Were outcomes measured in the same way for all groups? 8. Were outcomes measured in a reliable way? 9. Was there adequate follow-up of participants (>80%)? 10. Was appropriate statistical analysis used? 11. Were the outcomes of those who withdrew included in description and analysis? Overall appraisal: Include Exclude More info needed Comments (include reasons for exclusion)

15 APPENDIX III JBI CRITICAL APPRAISAL FORM FOR NON RANDOMISED CONTROLLED TRIALS Factorsinfluencingdiabetescareoutcomesinpatientswithtype1diabetesaftertransitionfrom paediatrictoadulthealthcare:asystematicreview Reviewer Author Date Year RecordNumber Yes(1) No(0) Unclear(0) 1. Are participant selection and inclusion criteria clearly outlined? 2. Are the methods for allocation to treatment groups outlined? 3. Are outcome methods clearly defined? 4. Are outcome methods assessed using objective criteria? 5. Is validation of assessment tools outlined? 6. Is sufficient detail of the intervention provided? 7. Was an appropriate data analysis method used? Overall appraisal: Include Exclude More info needed Comments (include reasons for exclusion)

16 APPENDIX IV DATA EXTRACTION FORM Factorsinfluencingdiabetescareoutcomesinpatientswithtype1diabetesaftertransitionfrom paediatrictoadulthealthcare:asystematicreview Author/s Year Journal Title Reviewer RecordNumber StudyMethod Setting InclusionCriteria: Group1 Group2 Participants Numberineachgroup Meanage GenderF/M Principaldiagnosis Participantsexcluded fromstudy Number: Reason: Number: Reason: Intervention Descriptionof intervention

17 Interventiondelivery(eg Nurse,Dr,Psychologist) Durationofintervention Methodofdelivery(eg. facetoface,telephone, website) Frequencyoffollow up Outcomes Diabetescontrolas measuredbyhba1c Losstofollow up Adherencetotherapy Incidenceofhospital admissionforacute diabetescomplications Clinicattendancerates Others Uptakeofscreeningfor longtermdiabetes complications Costeffectivenessof intervention Healthrelatedqualityof life Patientsatisfaction Author sconclusions: Reviewer sconclusions: