Background: Health-related quality of life (HRQoL) is a commonly used health outcome. For many acute conditions (e.g. fractures), retrospective measurement of HRQoL is necessary to establish pre-morbid health status. However, the validity of retrospective measurement of HRQoL following an intervening significant health event has not been established. The aim of this study was to test the validity of retrospective measurement (recall) of HRQoL by using a test-retest design to measure reliability and agreement between prospective and retrospective patientreported HRQoL before and after an intervening health event (elective orthopaedic surgery). Method: Participants were recruited from the pre-admission clinic of a metropolitan hospital. Participants were assessed for their HRQoL using the EQ-5D-5L at two time-points; prospectively at 2 weeks prior to their date of surgery and then retrospectively (recalling their pre-operative health) following elective hip or knee joint replacement surgery. Prospective measurements were compared with retrospective measurements for the five domain scores (nominal data) using intra-class correlation and for the EQ-Index score and EQ-Visual Analogue Scale (VAS) score (continuous data), using Pearson's correlation. Agreement was tested in continuous variables using Lin's coefficient of concordance (p c) and Bland-Altman plots. Results: One hundred seventy-four patients consented to participate. Eighty-eight paired prospective and retrospective scores were collected and there was a median between-test period of 15 days. At a group level, the prospective measurements were similar to the retrospective measurements; the modes and means of the five domain scores were not different and the mean differences (MD) between the scores for EQ-Index (MD = 0.02, on a scale of 0-1) and EQ-VAS (MD = 0.53, on a scale of 1-100) were negligible. However, the correlation of paired scores was varied; the range of domain score correlations was 0.52 to 0.74, the concordance was substantial for the EQ-Index scores (p c = 0.76, 95% CI = 0.66, 0.84) and moderate for the EQ-VAS scores (p c = 0.46, 95% CI = 0.28, 0.61). Conclusion: Agreement between prospective and retrospective measurements was high at a group level and moderate to substantial at an individual level. Retrospective measurement of HRQoL using the EQ-5D-5L in an orthopaedic clinical context is a valid alternative to using reference data to estimate baseline or pre-morbid health status.
Data unavailability impedes research transparency and is a major problem for individual participant data (IPD) meta‐analyses as it reduces statistical power, increases risk of bias, and may even preclude completion. The primary objectives of this study were to determine IPD sharing plans reported in recently registered clinical trial registration records, how data sharing commitment relates to clinical trial characteristics, and principal investigators' attitudes, motivations and barriers to data sharing. The secondary objective was to derive recommendations to overcome identified barriers to data sharing. This was a retrospective cohort study of all interventional trials registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) from 1 December 2018 to 30 November 2019, and an online cross‐sectional survey of their principal investigators. In the cohort study of all clinical trials registered on the ANZCTR in the study period (n = 1517), commitment to share data was low (22%, 329/1517). In the cross‐sectional survey (n = 281, 23% response rate), principal investigators showed strong support for the concept of data sharing (77%, 216/281) but a substantially lower intention to actually share data from their clinical trials (40%, 111/281). Major barriers to data sharing included lacking informed consent to share data, protecting participant confidentiality and preventing misinterpretation of data or misleading secondary analyses. There is a gap between high in‐principle support for data sharing, and low in‐practice intention from investigators to share data from their own clinical trials. Multiple pathways exist to bridge this gap by addressing the identified barriers to data sharing.
Although pain is widely recognized to be a multidimensional experience and defined as such, unidimensional pain measurement focusing on pain intensity prevails in the pediatric acute pain context. Unidimensional assessments fail to provide a comprehensive picture of a child’s pain experience and commonly do little to shape clinical interventions. The current review paper overviews the theoretical and empirical literature supporting the multidimensional nature of pediatric acute pain. Literature reporting concordance data for children’s self-reported sensory, affective and evaluative pain scores in the acute pain context has been reviewed and supports the distinct nature of these dimensions. Multidimensional acute pain measurement holds particular promise for identifying predictive markers of chronicity and may provide the basis for tailoring clinical management. The current paper has described key reasons contributing to the widespread use of unidimensional, rather than multidimensional, acute pediatric pain assessment protocols. Implications for clinical practice, education and future research are considered.
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