Effectiveness and safety of intravenous therapy at home for children and adolescents with acute and chronic illnesses: a systematic review protocol Helena Hansson 1 Anne Brødsgaard 2 1 Department of Paediatric and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Denmark, 2 Department of Paediatrics 460, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark Review question/objective: The objectives of this systematic review are to assess the effectiveness and safety of intravenous therapy at home compared with in-patient intravenous therapy in acute and chronically ill children and adolescents. Outcomes will include improvement of the illness, duration of treatment, clinical complications, adverse effects, mortality, re-admissions and preference for place of care by individuals and/or families. Keywords Adolescents; children; home care; home-based care; intravenous therapy Background A child s hospitalization is a stressful event and has a substantial emotional and social impact on the whole family. 1,2 There is an international policy and practice advocating that children and young people who are ill should be cared for at home as much as possible. 3,4 Pediatric hospital care at home (PHCH) is an alternative provision of care that refers to the provision of hospital services to the patients in their own home that would otherwise necessitate a hospital admission or an outpatient visit. 3 The provision of PHCH for children with acute and chronic illnesses is increasing in highincome countries due to increased survivorship, medical and technological developments, improvements in supportive care and costs of health care as well as potential psychosocial benefits for the children and their families. 3 5 The organization of PHCH differs both nationally and internationally and is either based at the hospital, which provides an outreach service, the community or a private healthcare agency. Services provided are, for example, (1) intravenous antibiotics, (2) intravenous chemotherapy, (3) blood samples drawn from a central venous line or peripheral vein, and (4) palliative care. 6 8 There are a number of factors that are important when considering PHCH: (1) the quality of care and Correspondence: Helena Hansson, helena.hansson@regionh.dk There is no conflict of interest in this project. DOI: 10.11124/JBISRIR-2016-002988 safety, (2) no increase in adverse events and mortality rate, (3) no additional strain on the child and family members, (3) no decrease in the family member s satisfaction with care, and (4) the costeffectiveness and the organizational structure within which these interventions are provided. 5,9 Although the home environment may have a positive impact on the children s recovery and wellbeing, it must be taken into account that the shift to home care may raise concerns about parental and professional roles and responsibilities. 10 Furthermore, home care implies a loss of privacy for families by the presence of medical equipment and healthcare professionals in the home environment. 10 Administration of intravenous therapy at home is an increasingly important area of child health care, especially for children with complex and chronic illnesses. Three studies indicate that intravenous chemotherapy can be safely managed at home. 11 13 In the randomized crossover trial by Stevens et al., 12 community-based nurses provided home chemotherapy to 23 children with leukemia. They showed both improvements and decrements in parent-reported health-related quality of life of the children, and no effect on parents burden of care, adverse events or costs compared with inpatient care. Despite the increasing provision of PHCH, the evidence base is limited. A Cochrane systematic review conducted by Parab et al. 4 evaluated the impact of specialist home-based nursing services JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 28
for children with acute and chronic illnesses in RCTs or quasi-randomized trials. 4 The last database search was in February 2012 and studies found did not have safety as an outcome measure. These included seven studies of which only one had intravenous therapy as an intervention. 4 The results showed insufficient evidence to support the effectiveness of specialist homebased nursing services in reducing hospital admissions, but suggested that home care may lead to greater parent satisfaction, improved quality of life for the child and a reduction in length of stay in hospital. 4 Another Cochrane systematic review by Balaguer and González de Dios 14 evaluated home versus hospital intravenous antibiotic therapy for cystic fibrosis in RCTs and quasi-randomized controlled studies. They found one RCT, which suggested that clinical outcomes, adverse events and complications were the same at home and in hospital. Parker et al. 3 conducted a systematic review aimed to establish the strength of international evidence on the effectiveness and costs of PHCH in RCTs and comparative studies. Parker et al. 3 found the quality of the included trials to be low, but also suggested that the clinical outcomes for children and caregiver burden on families were the same at home and in hospital. There was suggestive evidence of reduced costs for families compared with hospital care and that pediatric home care may reduce costs for health services. 3 As described above, pediatric healthcare providers have limited evidence-based knowledge of the effectiveness of PHCH when considering program development for children and adolescents with acute and chronic illnesses. Therefore, there is a need for a systematic review that also includes empirical data from descriptive studies and case series to expand current knowledge on PHCH. Thus, the aim of this systematic review is to explore the international evidence on the effectiveness and safety of intravenous therapy at home. Inclusion criteria Types of participants The current review will consider studies that include children and adolescents 0 18 years of age with acute and/or chronic illnesses and complex conditions, and who receive intravenous therapy. Types of intervention The current review will consider studies that evaluate the effect of intravenous therapy provided to children and adolescents with acute illnesses and/ or chronic and complex conditions in the patient s own home by healthcare professionals or parents. This includes intravenous therapies such as chemotherapy, antibiotics, parenteral nutrition or hydration in which the entire course of therapy is provided at home, as well as interventions in which therapy is initiated at the hospital followed by home therapy regardless of duration of therapy. It includes a variety of administration methods, for example, transportable infusor devices initiated at the hospital and administration of the therapy by healthcare professionals at home. When relevant, the comparator being used is in-patient intravenous therapy. The following will be excluded: (a) studies that include both children and adults that do not specifically report separate results for the children, (b) studies related to services provided in ambulatory or outpatient settings, (c) studies using oral therapy, and (d) qualitative studies. Outcomes The current review will consider studies that include the following outcomes: re-admissions, length of hospitalization, mortality, adverse events, clinical outcomes (e.g. improvement of the illness and time for recovery of illness), duration of treatment, clinical complications (e.g. overhydration and acquisition of new microbial infection), adverse effects (those related to the therapy e.g. gastrointestinal symptoms, and those related to the insertion sight e.g. thrombophlebitis and infection) and child and parental satisfaction. Types of studies The current review will consider both experimental and epidemiological study designs including randomized controlled trials, non-randomized controlled trials, quasi-experimental studies, before and after studies, prospective and retrospective cohort studies, case-control studies and analytical crosssectional studies. Search strategy The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by an analysis of the text words contained in the title JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 29
and abstract, and of the index terms used to describe the article. A second search, using all identified keywords and index terms, will then be undertaken across all included databases. Third, the reference list of all identified reports and articles will be searched for additional studies. Studies published in any language will be considered for inclusion in this review. The databases to be searched include: Medline CINAHL Embase PsycINFO Cochrane Central Register of Controlled Trials (CENTRAL) LILACS Web of Science Sociological Abstracts (Sociofile) ClinicalTrials.gov International Clinical Trials Registry Platform The search for unpublished studies will include: The archives of abstracts from the Pediatric Academic Societies (incorporating the American Ambulatory Pediatric Association and the Society for Pediatric Research) ProQuest Dissertations and Theses Initial keywords to be used will be: infant, child, preschool, adolescent; paediatric or pediatric; home care services, hospital-based home care, home nursing, home care agencies home infusion home or homebased or domicil, community health nursing, nursing outreach; drug therapy, chemotherapy, intravenous; randomized controlled trial, trial, evaluation study, comparative study, experimental study, observational study, cohort study, case study pre test, pretest, post test, posttest, quasi-experimental studies, case series. Assessment of methodological quality Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion or with a third reviewer. Data extraction Quantitative data will be extracted by two independent reviewers from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Data synthesis Quantitative data will, where possible, be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard chi-square and also explored using subgroup analyses based on the different study designs included in this review. Where statistical pooling is not possible, the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate. References 1. Björk M, Wibe T, Hallström I. An everyday struggle Swedish families lived experiences during a child s cancer treatment. J Pediatr Nurs 2009;24(5):423 32. 2. Coyne I. Children s experiences of hospitalization. J Child Health Care 2006;10(4):326 36. 3. Parker G, Spiers G, Gridley K, Atkin K, Birks Y, Lowson K, et al. Systematic review of international evidence on the effectiveness and costs of paediatric home care for children and young people who are ill. Child Care Health Dev 2013; 39(1):1 19. 4. Parab CS, Cooper C, Woolfenden S, Piper SM. Specialist home-based nursing services for children with acute and chronic illnesses. Cochrane Database Syst Rev 2013;6:. 5.FrierdichS,GoesC,DaddG.Communityandhomecare services provided to children with cancer: a report from the Children s Cancer Group Nursing Committee Clinical Practice Group. J Pediatr Oncol Nurs 2003;20 (5):252 9. 6. Parker G, Bhakta P, Lovett C, Olsen R, Paisley S, Turner D. Paediatric home care: a systematic review of randomized trials on costs and effectiveness. J Health Serv Res Policy 2006;11(2):110 9. JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 30
7. Hansson H, Johansen C, Hallström I, Kjærgaard H, Schmiegelow K. Hospital-based home care for children with cancer. Pediatr Blood Cancer 2011;57(3):369 77. 8. Vickers J, Thompson A, Collins GS, Childs M, Hain R. Place and provision of palliative care for children with progressive cancer: a study by the Paediatric Oncology Nurses Forum/ United Kingdom Children s Cancer Study Group Palliative Care Working Group. J Clin Oncol 2007;25(28): 4472 4476. 9. Kandsberger D. Factors influencing the successful utilization of home health care in the treatment of children and adolescents with cancer. Home Health Care Manage Prac 2007;19(6):450 5. 10. Kirk S, Glendinning C. Developing services to support parents caring for a technology-dependent child at home. Child Care Health Dev 2004;30(3):209 18. 11. Hansson H, Kjaergaard H, Johansen C, Hallström I, Christensen J, Madsen M, et al. Hospital-based home care for children with cancer: feasibility and psychosocial impact on children and their families. Pediatr Blood Cancer 2013;60(5):865 72. 12. Stevens B, Croxford R, McKeever P, Yamada J, Booth M, Daub S, et al. Hospital and home chemotherapy for children with leukemia: a randomized cross-over study. Pediatr Blood Cancer 2006;47(3):285 92. 13. Close P, Burkey E, Kazak A, Danz P, Lange B. A prospective, controlled evaluation of home chemotherapy for children with cancer. Pediatrics 1995;95(6):896 900. 14. Balaguer A, González de Dios J. Home versus hospital intravenous antibiotic therapy for cystic fibrosis. Cochrane Database Syst Rev 2015;12:CD001917. JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 31
Appendix I: Appraisal instruments MAStARI appraisal instrument JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 32
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Appendix II: Data extraction instruments MAStARI data extraction instrument JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE 35
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