ReviewQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2014
Patient-important activity and participation outcomes in clinical trials involving children with chronic conditions.
Review in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Assessing the engagement of children and families in selecting patient-reported outcomes (PROs) and developing their measures: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021Pooled it
- Incorporation of patient-reported outcomes in pediatric cancer clinical trials: design, implementation, and dissemination.Journal of the National Cancer Institute · 2025Article
- Patient-Reported Outcomes in Pediatric Patients With Cancer.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2023Article
- Patients' perspective on supposedly patient-relevant process and outcome parameters: a cross-sectional survey within the 'PRO patients study'.BMC health services research · 2022Article
- Patient-relevant outcomes: what are we talking about? A scoping review to improve conceptual clarity.BMC health services research · 2020Article
- Strategies to address anaemia among pregnant and lactating women in India: a formative research study.Public health nutrition · 2020Article
- Partnering with families of children with medical complexity to evaluate interventions.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2018Article
- From the Child's Word to Clinical Intervention: Novel, New, and Innovative Approaches to Symptoms in Pediatric Palliative Care.Children (Basel, Switzerland) · 2018Article
- Development of Activity and Participation Norms among General Adult Populations in Taiwan.International journal of environmental research and public health · 2017Article
- Functional recovery following critical illness in children: the "wee-cover" pilot study.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2015Article
- Measuring pediatric patient-reported outcomes: good progress but a long way to go.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
purposeChildren with chronic conditions experience medical issues over long-term periods of time which can have lasting emotional and social consequences impacting daily life and functioning. Activities and participation outcomes are needed in order to comprehensively assess child-important health in clinical trials. Our objective was to review the extent to which activity and participation outcomes are included in clinical trials of childhood chronic disease and to determine what trial characteristics are associated with their use.
methodsA review of a large clinical trial registration database (clinicaltrials.gov) was conducted over the 2010 calendar year. The measures used to assess primary and secondary endpoints were coded according to the ICF classification system. Trial characteristics that might be associated with activity and participation outcome use such as sponsorship type, intervention type, health condition, whether the trial was focused on pediatric patients, phase of trial and sample size were also extracted and explored with univariable and multivariable regressions.
resultsFour hundred and ninety-nine trials met inclusion criteria, 495 of which had complete information about hypothesized predictors. Only 36 out of 495 trials included an activity and participation outcome as part of the trial evaluation process. Both univariable and multivariable regression models showed that non-drug trials and late phase of trial (phase IV) showed the strongest likelihood with whether a trial would include an activity and participation outcome. DISCUSSION: Most registered clinical trials for children with chronic or ongoing medical conditions do not include a comprehensive approach to health outcomes assessment, especially drug trials and early phase trials. Outcome measures in pediatric clinical trials are lagging relative to World Health Organization standards for comprehensive health evaluation.
Indexed as
Identifiers
24026628What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.