ReviewQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2016
The current practice of handling and reporting missing outcome data in eight widely used PROMs in RCT publications: a review of the current literature.
Review in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses 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
35 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- How to prevent missing data in cost-effectiveness analyses alongside cardiovascular disease trials? A review on methods of administration of patient-reported outcomes.Journal of patient-reported outcomes · 2026Pooled it
- Pooled it
- Methodology of analysis of cognitive impairment in longitudinal randomized clinical trials in oncology: a scoping review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Keeping a PROMise: embedding patient voices in ophthalmic outcomes.The British journal of ophthalmology · 2026Article
- Missing data considerations for patient reported outcome measures in randomized controlled trials.Journal of patient-reported outcomes · 2026Article
- Introducing the Subjective Knee Value for Daily Activity (SKV-d) and Sport (SKV-s) as Single-Item Measures to Assess Knee Function in Athletes.Orthopaedic journal of sports medicine · 2026Article
- Comparison of different approaches in handling missing data in longitudinal multiple-item patient-reported outcomes: a simulation study.Health and quality of life outcomes · 2025Article
- Evaluating the Population-Based Usage and Benefit of Digitally Collected Patient-Reported Outcomes and Experiences in Patients With Chronic Diseases: The PROMchronic Study Protocol.JMIR research protocols · 2024Article
- Predictors of urine toxicology and other biologic specimen missingness in randomized trials of substance use disorders.Drug and alcohol dependence · 2024Article
- Trial arm outcome variance difference after dropout as an indicator of missing-not-at-random bias in randomized controlled trials.Biometrical journal. Biometrische Zeitschrift · 2023Article
- Duration of rehabilitation therapy to achieve a minimal clinically important difference in mobility, walking endurance and patient-reported physical health: an observational study.Journal of rehabilitation medicine · 2023Observational
- Quality of life of older gynecologic oncology patients at the initiation of chemotherapy.Nursing open · 2023Article
- Article
- A clustered randomized controlled trial of symptom screening and automatic referral for supportive care for patients with GI cancer care needs.Canadian oncology nursing journal = Revue canadienne de nursing oncologique · 2023Article
- Article
- Sensitivity analyses for data missing at random versus missing not at random using latent growth modelling: a practical guide for randomised controlled trials.BMC medical research methodology · 2022Article
- A comparison of methods to address item non-response when testing for differential item functioning in multidimensional patient-reported outcome measures.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022Article
- Sequential Multiple Imputation for Real-World Health-Related Quality of Life Missing Data after Bariatric Surgery.International journal of environmental research and public health · 2022Article
- The subjective knee value is a valid single-item survey to assess knee function in common knee disorders.Archives of orthopaedic and trauma surgery · 2022Article
- Sensitivity to missing not at random dropout in clinical trials: Use and interpretation of the trimmed means estimator.Statistics in medicine · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
purposePatient-reported outcome measures (PROMs) are designed to assess patients' perceived health states or health-related quality of life. However, PROMs are susceptible to missing data, which can affect the validity of conclusions from randomised controlled trials (RCTs). This review aims to assess current practice in the handling, analysis and reporting of missing PROMs outcome data in RCTs compared to contemporary methodology and guidance.
methodsThis structured review of the literature includes RCTs with a minimum of 50 participants per arm. Studies using the EQ-5D-3L, EORTC QLQ-C30, SF-12 and SF-36 were included if published in 2013; those using the less commonly implemented HUI, OHS, OKS and PDQ were included if published between 2009 and 2013.
resultsThe review included 237 records (4-76 per relevant PROM). Complete case analysis and single imputation were commonly used in 33 and 15 % of publications, respectively. Multiple imputation was reported for 9 % of the PROMs reviewed. The majority of publications (93 %) failed to describe the assumed missing data mechanism, while low numbers of papers reported methods to minimise missing data (23 %), performed sensitivity analyses (22 %) or discussed the potential influence of missing data on results (16 %).
conclusionsConsiderable discrepancy exists between approved methodology and current practice in handling, analysis and reporting of missing PROMs outcome data in RCTs. Greater awareness is needed for the potential biases introduced by inappropriate handling of missing data, as well as the importance of sensitivity analysis and clear reporting to enable appropriate assessments of treatment effects and conclusions from RCTs.
Indexed as
Identifiers
What 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.