Patient-Reported Outcomes in Adults With Congenital Heart Disease Following Hospitalization (from APPROACH-IS)

In this international study, we (1) compared patient-reported outcomes (PROs) in adults with congenital heart disease (CHD) who had versus had not been hospitalized during the previous 12 month, (2) contrasted PROs in patients who had been hospitalized for cardiac surgery versus nonsurgical reasons, (3) assessed the magnitude of differences between the groups (i.e., effect sizes), and (4) explored differential effect sizes between countries. APPROACH-IS was a cross-sectional, observational study that enrolled 4,028 patients from 15 countries (median age 32 years; 53% females). Self-report questionnaires were administered to measure PROs: health status; anxiety and depression; and quality of life. Overall, 668 patients (17%) had been hospitalized in the previous 12 months. These patients reported poorer outcomes on all PROs, with the exception of anxiety. Patients who underwent cardiac surgery demonstrated a better quality of life compared with those who were hospitalized for nonsurgical reasons. For significant differences, the effect sizes were small, whereas they were negligible in nonsignificant comparisons. Substantial intercountry differences were observed. For various PROs, moderate to large effect sizes were found comparing different countries. In conclusion, adults with CHD who had undergone hospitalization in the previous year had poorer PROs than those who were medically stable. Researchers ought to account for the timing of recruitment when conducting PRO research as hospitalization can impact results. In this international study, we (1) compared patient-reported outcomes (PROs) in adults with congenital heart disease (CHD) who had versus had not been hospitalized during the previous 12 month, (2) contrasted PROs in patients who had been hospitalized for cardiac surgery versus nonsurgical reasons, (3) assessed the magnitude of differences between the groups (i.e., effect sizes), and (4) explored differential effect sizes between countries. APPROACH-IS was a cross-sectional, observational study that enrolled 4,028 patients from 15 countries (median age 32 years; 53% females). Self-report questionnaires were administered to measure PROs: health status; anxiety and depression; and quality of life. Overall, 668 patients (17%) had been hospitalized in the previous 12 months. These patients reported poorer outcomes on all PROs, with the exception of anxiety. Patients who underwent cardiac surgery demonstrated a better quality of life compared with those who were hospitalized for nonsurgical reasons. For significant differences, the effect sizes were small, whereas they were negligible in nonsignificant comparisons. Substantial intercountry differences were observed. For various PROs, moderate to large effect sizes were found comparing different countries. In conclusion, adults with CHD who had undergone hospitalization in the previous year had poorer PROs than those who were medically stable. Researchers ought to account for the timing of recruitment when conducting PRO research as hospitalization can impact results. Patient-reported outcomes (PROs) are "any reports of the status of a patient's health condition that come directly from the patient, without interpretation of the patient's response by a clinician or anyone else."1US Department of Health and Human Service Food and Drug AdministrationGuidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. FDA, Silver Spring, MD2009Google Scholar PRO research has gained traction among patients with congenital heart disease (CHD).2Moons P Patient-reported outcomes in congenital cardiac disease: are they as good as you think they are?.Cardiol Young. 2010; 20: 143-148Crossref PubMed Scopus (14) Google Scholar,3Bratt EL Moons P Forty years of quality-of-life research in congenital heart disease: temporal trends in conceptual and methodological rigor.Int J Cardiol. 2015; 195: 1-6Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar A large proportion of these patients fare well, and typically present for routine evaluation at outpatient clinics every 1 to 5 years, depending on their clinical scenario and complexity of the heart defect.4Landzberg MJ Murphy Jr., DJ Davidson Jr., WR Jarcho JA Krumholz HM Mayer Jr., JE Mee RB Sahn DJ Van Hare GF Webb GD Williams RG Task force 4: organization of delivery systems for adults with congenital heart disease.J Am Coll Cardiol. 2001; 37: 1187-1193Crossref PubMed Scopus (135) Google Scholar However, patients sometimes require hospital admission, either because of deteriorating clinical status or for elective assessment or interventional procedure. When PROs are measured during or following hospitalization, it may be presumed that scores would generally be worse than when completed during outpatients visit or from patients' homes. Therefore, we aimed (1) to described PROs in individuals who had versus had not been hospitalized during the previous 12 months, (2) to contrast PROs in patients who had been hospitalized for cardiac surgery versus nonsurgical reasons, (3) to assess the magnitude of differences between the groups, and (4) to explore differential effect sizes between countries. This analysis is a substudy of APPROACH-IS (Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease – International Study), a cross-sectional study conducted in 15 countries. The rationale and study protocol of APPROACH-IS were extensively described in a dedicated methods paper.5Apers S Kovacs AH Luyckx K Alday L Berghammer M Budts W Callus E Caruana M Chidambarathanu S Cook SC Dellborg M Enomoto J Eriksen K Fernandes SM Jackson JL Johansson B Khairy P Kutty S Menahem S Rempel G Sluman MA Soufi A Thomet C Veldtman G Wang JK White K Moons P Approach-Is consortiumInternational Society for Adult Congenital Heart DiseaseAssessment of patterns of patient-reported outcomes in adults with congenital heart disease - international study (APPROACH-IS): rationale, design, and methods.Int J Cardiol. 2015; 179: 334-342Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar Briefly here, we included 4,028 adults (≥18 years) with CHD who were followed-up at a CHD center or included in a national/regional registry, and who had the physical, cognitive, and language capabilities required to complete self-report questionnaires.5Apers S Kovacs AH Luyckx K Alday L Berghammer M Budts W Callus E Caruana M Chidambarathanu S Cook SC Dellborg M Enomoto J Eriksen K Fernandes SM Jackson JL Johansson B Khairy P Kutty S Menahem S Rempel G Sluman MA Soufi A Thomet C Veldtman G Wang JK White K Moons P Approach-Is consortiumInternational Society for Adult Congenital Heart DiseaseAssessment of patterns of patient-reported outcomes in adults with congenital heart disease - international study (APPROACH-IS): rationale, design, and methods.Int J Cardiol. 2015; 179: 334-342Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar,6Apers S Kovacs AH Luyckx K Thomet C Budts W Enomoto J Sluman MA Wang JK Jackson JL Khairy P Cook SC Chidambarathanu S Alday L Eriksen K Dellborg M Berghammer M Mattsson E Mackie AS Menahem S Caruana M Veldtman G Soufi A Romfh AW White K Callus E Kutty S Fieuws S Moons P Approach-Is consortiumIsachdQuality of life of adults with congenital heart disease in 15 countries: evaluating country-specific characteristics.J Am Coll Cardiol. 2016; 67: 2237-2245Crossref PubMed Scopus (87) Google Scholar The study was conducted in keeping with the Declaration of Helsinki and was approved by the Institutional Review Board of the University Hospitals Leuven/KU Leuven, Belgium (coordinating center) and by the local institutional review boards of the participating centers (when required). For 3,969 patients (98.5%), information about inpatient cardiac admissions was available. Therefore, the current study was performed on this subsample. Informed consent was obtained from each patient. Three domains of PROs were assessed using self-report questionnaires: (1) perceived health status using the 12-item Short Form Health Survey (SF-12)7Ware JE Kosinski M Turner-Bowker DM Sundaram M Gandek B Maruish ME User's Manual for the SF-12v2 Health Survey.Second Edition. QualityMetric, Incorporated, Lincoln, RI2009Google Scholar and the EuroQol-5D Visual Analog Scale8EuroQolGroupEuroQol–a new facility for the measurement of health-related quality of life.Health Policy. 1990; 16: 199-208Crossref PubMed Scopus (10582) Google Scholar; (2) psychological functioning using the Hospital Anxiety and Depression Scale9Zigmond AS Snaith RP The hospital anxiety and depression scale.Acta Psychiatr Scand. 1983; 67: 361-370Crossref PubMed Scopus (28785) Google Scholar; and (3) QoL using a Linear Analog Scale10Moons P Van Deyk K De Bleser L Marquet K Raes E De Geest S Budts W Quality of life and health status in adults with congenital heart disease: a direct comparison with healthy counterparts.Eur J Cardiovasc Prev Rehabil. 2006; 13: 407-413Crossref PubMed Scopus (0) Google Scholar; and the Satisfaction With Life Scale.11Diener E Emmons RA Larsen RJ Griffin S The satisfaction with life scale.J Pers Assess. 1985; 49: 71-75Crossref PubMed Scopus (14834) Google Scholar Demographic data were collected through self-report questionnaires. Medical data were obtained through chart review, including (1) whether patients had cardiac inpatient hospitalizations over the previous 12 months and (2) the date of the most recent cardiac surgery. Online Table 1 provides an expanded definition of the domains as applied in APPROACH-IS as well as the interpretation of scores for the individual PRO measures. Data analysis was performed using IBM SPSS Statistics for Windows, version 25 (IBM Corp., Armonk, NY, USA). PRO scores were expressed as means and standard deviations. Other descriptive statistics were reported as medians and interquartile ranges, given that the data were not normally dist

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