Table 2 Characteristics of the 12 articles referring to other studies or special classifications to justify patient relevance of outcomes
From: Patient-relevant outcomes: what are we talking about? A scoping review to improve conceptual clarity
Authors | Objective/ motivation of article | Type of article/ study | Terms used synonymously | Indicator disease/intervention | Outcomes considered patient-relevant [instrument, if applicable] |
|---|---|---|---|---|---|
Adie et al. 2017 [4] | Determination of the proportion of patient-important primary outcomes in surgical randomized controlled trials | Systematic review & meta-analysis | 2 terms: - patient-important outcome - patient-centered outcome | Surgical interventions | - mortality/survival - pain - function - quality of life - any morbid event or symptom - patient satisfaction - any intervention to address the previous outcomes |
Ameur et al. 2017 [27] | Determination whether recently published an ongoing systematic reviews with meta-analyses of therapeutic interventions assess patient-important outcomes | Methodological review | 1 term: - patient-important outcome | Generic; therapeutic interventions | - mortality - clinical events - pain - quality of life - therapeutic decision - function |
Fei et al. 2018 [28] | Examination of the impact of adding ezetimibe to statins on patient-important outcomes in patients at high cardiovascular risk | Narrative systematic review | 1 term: - patient-important outcome | High cardiovascular risk | - all-cause mortality - cardiovascular mortality - non-fatal stroke - non-fatal myocardial infarction - adverse events |
Gaudry et al. 2017 [5] | Investigation whether randomized controlled trials in critically ill patients assess patient-important outcomes | Systematic review | 1 term: - patient-important outcome | Critical illness | - mortality - quality of life after Intensive Care Unit discharge - functional, cognitive, and neurological outcomes after Intensive Care Unit discharge |
Kvitkina et al. 2014 [29] | Description of the feasibility of the early benefit assessment of novel agents on the basis of patient-relevant outcomes by characterizing the outcomes available in the companies dossiers and comparing them to outcomes defined as patient-relevant by the German Institute for Quality and Efficiency in Health Care | Systematic Review | 1 term: - patient-relevant outcome | Drugs (novel agents) | - mortality - morbidity - health-related quality of life - adverse events |
Roos et al. 2000 [30] | Evaluation of patient-relevant outcomes preoperatively and three months after partial meniscectomy | Prospective follow-up study | 1 term: - patient-relevant outcome | Partial meniscectomy | - general health status [SF-36] - knee-specific health status: pain, symptoms, activities of daily life, sports and recreation function, knee-related quality of life, functional disability [KOOS, Lysholm Knee Score] |
Schumacher et al. 2016 [31] | Assessment of current approaches to measure the impact of tuberculosis nucleic acid amplification tests on patient-important outcomes in adults with possibly tuberculosis and/or drug-resistant tuberculosis | Methodological review | 2 terms: - patient-important outcome - patient outcome | Tuberculosis nucleic acid amplification tests | - culture conversion - tuberculosis treatment outcomes - infection control/ contact tracing - morbidity - mortality |
Singh et al. 2017 [32] | Simulation of the long-term effect of novel agents versus chemotherapy-based regimens on progression-free survival, overall survival and health-related quality of life in patients with chronic lymphocytic leukemia | Review & data simulation | 2 terms: - patient-relevant outcome - patient-relevant benefit | Chronic lymphocytic leukemia | - progression-free survival - overall survival - quality-adjusted life years - post-progression survival |
Wieseler et al. 2013 [33] | Determination of the information gain between clinical study reports and publicly available sources for patient-relevant outcomes included in health technology assessments for drugs | Systematic review | 2 terms: - patient-relevant clinical trial outcome - patient-relevant outcome | Drugs | - mortality - clinical events - symptoms - health-related quality of life - (serious) adverse events |
Yordanov et al. 2018 [34] | 1. Evaluation whether the outcomes reported in the summary of finding table of Cochrane reviews could be considered patient-important 2. Evaluation of the quality of evidence for these outcomes | Methodological review | 1 term - patient-important outcome / PIO | Generic | - mortality - other clinical events (e.g., myocardial infarction, stroke) - adverse events - function (e.g., anxiety, depression, disability) - pain - quality of life - therapeutic decisions |
El Dib et al. 2017 [35] | Review of randomized controlled trials on diagnostic tests with regard to their topic areas, population, setting, study groups, patient-important outcomes, risk of bias, and results | Systematic review | 1 term: - patient-important outcome | Diagnostic tests | - mortality - morbidity - symptoms - quality of life - functional status |
Fayed et al. 2014 [36] | 1. Review to which extent activity and participation outcomes are included in pediatric clinical trials 2. Determination what characteristics are associated with using theses outcomes | Systematic review | 3 terms: - patient-important outcome - patient-important activity and participation outcome - child and family-important outcome | Generic; children with chronic conditions | - body function - activity - participation - environmental factors - personal factors - health condition - general health |