| Literature DB >> 29471308 |
Angela MacCarthy1, Shona Kirtley1, Jennifer A de Beyer1, Douglas G Altman1, Iveta Simera1.
Abstract
Many reports of health research omit important information needed to assess their methodological robustness and clinical relevance. Without clear and complete reporting, it is not possible to identify flaws or biases, reproduce successful interventions, or use the findings in systematic reviews or meta-analyses. The EQUATOR Network (http://www.equator-network.org/) promotes responsible reporting and the use of reporting guidelines to improve the accuracy, completeness, and transparency of health research. EQUATOR supports researchers by providing online resources and training. EQUATOR Oncology, a project funded by Cancer Research UK, aims to support cancer researchers reporting their research through the provision of online resources. In this article, our objective is to highlight reporting issues related to oncology research publications and to introduce reporting guidelines that are designed to aid high-quality reporting. We describe generic reporting guidelines for the main study types, and explain how these guidelines should and should not be used. We also describe 37 oncology-specific reporting guidelines, covering different clinical areas (e.g., haematology or urology) and sections of the report (e.g., methods or study characteristics); most of these are little-used. We also provide some background information on EQUATOR Oncology, which focuses on addressing the reporting needs of the oncology research community.Entities:
Mesh:
Year: 2018 PMID: 29471308 PMCID: PMC5846057 DOI: 10.1038/bjc.2017.407
Source DB: PubMed Journal: Br J Cancer ISSN: 0007-0920 Impact factor: 7.640
Examples of reporting problems in oncology studies
| Prognostic studies not published | Completed prognostic studies of biomarkers not published. | Conclusions drawn from systematic reviews may be inaccurate due to the evidence base not being complete (likely publication bias). | |
| Epidemiological studies: incomplete reporting of methodology | Under-reporting of methodological aspects of observational studies including: matching, absolute risks, lack of flow diagram and missing data. | Difficult for readers to assess the validity of the studies. | |
| Prognostic factor studies: methods poorly reported | Inadequate reporting of aspects of study design and implementation in studies of prognostic markers, including: power calculations, time of enrolment, lists of candidate variables, definition of outcomes and providing the assay reference. | Studies are often too small to detect modest effects, and results from a number of studies may be examined together in systematic reviews or meta-analyses. If methods and findings are not reported in sufficient detail, it is not possible to include studies in such reviews. | |
| Results not published | Trial findings that have been presented at professional meetings remain unreported or there is a delay in reporting. | Publication bias limits the available evidence base and, if decision to not publish is driven by results, distorts the overall evidence picture (likely publication bias). This can lead to treatments being used based on overoptimistic published results. | |
| Inconsistencies within publications | Differences between reporting in abstracts and the main body of the text of the published articles: for example, strong support for the experimental arm of the study in the abstract, but not in the main text of the report. | Busy clinicians and policymakers may only read the abstract of the article. Reading only the published abstract may lead to a distorted view of the overall study findings, with implications for physicians when making decisions about clinical care. | |
| Data published but with deficiencies | Poor reporting of adverse event collection, description of AE characteristics leading to withdrawals, and whether AEs were attributed to trial interventions. | If information about effects of complex, (often combined) therapies are unavailable, could invalidate the decision-making process for clinicians and their patients. | |
| Poor reporting of adverse events in surgery, lack of standardised description of adverse events. | Physicians cannot assess the benefits and risks to patients that are likely to be offered surgery. | ||
| Poor reporting of trial outcomes | Trial outcomes: Selective trial outcome reporting, such as a discrepancy between the planned and published primary trial endpoints. Lack of reporting of planned non-primary trial endpoints. | Difficult to reproduce studies with poor reporting of outcomes. Overestimation of intervention effect sizes, which has an impact on evidence-based clinical decision making. | |
| Patient-reported outcomes (PROs), quality of life: Poor reporting of methods of PRO collection and analysis, the pre-specified PRO hypothesis, methods for PRO collection and statistical approaches for dealing with missing data. | Patient-reported outcomes are essential in oncology trials. In conjunction with primary outcomes, such as survival, to allow the assessment of benefits and harms associated with the treatment. They are the ‘voice’ of the patients in the trial and therefore provide a unique perspective on the treatment; they should be addressed in the trial report. | ||
| Trial interventions | Replication and translation into clinical practice is impossible if there is not detailed information on the treatment administered under trial conditions. | ||
Generic reporting guidelines available in the EQUATOR Network database of reporting guidelines
| CONSORT | Parallel group randomised trials (extensions address other designs) | |
| STROBE | Observational studies in epidemiology: cohort, case-control studies, cross-sectional studies | |
| PRISMA | Systematic reviews and meta-analyses (in particular of randomised trials) | |
| CARE | Clinical case reports | |
| SRQR | Qualitative research | |
| COREQ | Qualitative research interviews and focus groups | |
| STARD | Diagnostic test accuracy studies | |
| TRIPOD | Studies developing, validating, or updating a prediction model, for either diagnosis or prognosis | |
| REMARK | Tumour marker prognostic studies | |
| SQUIRE | Quality improvement in health care | |
| CHEERS | Economic evaluations of health interventions | |
| ARRIVE | Bioscience research using laboratory animals | |
| SPIRIT | Clinical trial protocols | |
| PRISMA-P | Systematic reviews and meta-analysis protocols |
Oncology-specific reporting guidelines available on the EQUATOR website
| Myeloma clinical trials | Oncology, haematology | Whole report | 186 | Yes | |
| Phase 1 and phase 2 clinical trials in neuro-oncology | Oncology, neurology | Whole report | 16 | Yes | |
| Surgically-based therapeutic clinical trials | Oncology, neurology, surgery | Whole report | 8 | ||
| Therapeutic trials in acute myeloid leukaemia (AML) | Oncology, haematology | Whole report | 1149 | ||
| Clinical trials in cancer pain educational interventions | Oncology | Whole report | 7 | Yes | |
| Tumour marker prognostic studies | Oncology, genetics | Whole report | 313 | Yes | |
| The design and analysis of prognostic factor studies in non-small cell lung cancer (NSCLC) | Oncology, genetics, respiratory medicine | Whole report | 151 | Yes | |
| Reporting of BCR-ABL molecular testing | Oncology, haematology | Procedure/method, results | 4 | ||
| Reporting clinical trial results on electrochemotherapy | Oncology | Procedure/method, study characteristics, intervention, results, data, outcomes, ethical issues, research recommendations | 4 | Yes | |
| Standard definitions and endpoints for neoadjuvant clinical trials in breast cancer | Oncology | Terminology/definitions | 23 | ||
| Clinical trials in systemic light-chain amyloidosis | Oncology, haematology | Procedure/method, study characteristics, outcomes | 48 | ||
| Clinical trials for patients in the state of a rising prostate-specific antigen | Oncology, urology | Study characteristics, outcomes | 121 | Yes | |
| Flow cytometry minimal residual disease analysis and reporting in multiple myeloma | Oncology, haematology | Procedure/method, results | 3 | Yes | |
| Reporting system for correlation of cytogenetic and molecular genetic data with clinical data | Oncology, haematology | Procedure/method, intervention, outcomes | 1094 | Yes | |
| Reporting definitions, methodological and statistical issues for phase 3 clinical trials in chronic myeloid leukaemia | Oncology | Terminology/definitions, statistical methods and analyses | 30 | Yes | |
| Clinical platelet transfusion studies | Oncology, haematology | Procedure/method, intervention, outcomes, harms/adverse effects/safety data | 2 | ||
| Reporting embolisation treatment of vascular head, neck and brain tumours | Oncology, neurology, radiology, surgery | Terminology/definitions | 10 | Yes | |
| Reporting MRI evaluation of response after neoadjuvant radiotherapy in soft tissue sarcoma | Oncology, radiology | Images | 0 | Yes | |
| To promote standardisation and diminish variations in the acquisition, interpretation, and reporting of whole-body MRI scans for use in advanced prostate cancer | Oncology, urology, radiology, nuclear medicine | Images | Reference not found | Yes | |
| Reporting of post-neoadjuvant systemic therapy breast cancer specimens | Oncology, pathology | Procedure/method, study characteristics, terminology/definitions, intervention | 4 | Yes | |
| Reporting of health-related quality of life in clinical cancer trials | Oncology | Outcomes | 51 | ||
| Use of historical data for determining "go/no go" decision for definitive phase III testing | Oncology | Procedure/method, data | 32 | Yes | |
| Common terminology criteria for paediatric reporting of adverse events in oncology trials | Oncology, paediatrics | Terminology/definitions, harms/adverse effects/safety data | Reference not found | ||
| Presenting prognostic studies with missing covariate data | Oncology | Data | 87 | Yes | |
| Reporting case series of tumours of the colon and rectum | Oncology, gastroenterology, surgery | Procedure/method, study characteristics, intervention, results, data, outcomes | Journal indexed from 2008 onwards | ||
| Reporting of individual MRI studies in men with prostate cancer on active surveillance and for reporting the outcomes of cohorts of men with prostate cancer having MRI on active surveillance | Oncology, urology, radiology | Images | Reference not found | ||
| Standards for balanced reporting on websites and in newspapers | Oncology, obstetrics & gynaecology | 12 | |||
| Reporting clinical studies of radioembolisation of hepatic malignancies | Oncology, gastroenterology, radiology | Procedure/method, study characteristics, terminology/definitions, intervention, images, outcomes, harms/adverse effects/safety data | 78 | Yes | |
| Transcatheter therapies for hepatic malignancy | Oncology, gastroenterology, radiology, surgery | Procedure/method, study characteristics, terminology/definitions, outcomes, harms/adverse effects/safety data | 51 | Yes | |
| Reporting clinical studies and research on the use of ablation methods for the treatment of benign bone tumours and metastases involving bone and soft tissues beyond the liver and lung | Oncology, radiology | Procedure/method, study characteristics, intervention, results, images, outcomes, harms/adverse effects/safety data | 14 | Yes | |
| Percutaneous thermal ablation of primary renal cell carcinoma | Oncology, renal medicine, radiology, surgery | Procedure/method, study characteristics, terminology/definitions, intervention, images, outcomes, harms/adverse effects/safety data | 19 | Yes | |
| Percutaneous vertebral augmentation | Oncology, rheumatology, radiology, surgery | Procedure/method, study characteristics, intervention, outcomes, harms/adverse effects/safety data | 8 | Yes | |
| Reporting the various aspects of image-guided ablation therapy | Oncology, radiology | Study characteristics, terminology/definitions, intervention, results, images, statistical methods and analyses, outcomes, harms/adverse effects/safety data | 101 | Yes | |
| Reporting image-guided irreversible electroporation ablation therapy | Oncology, radiology | Terminology/definitions, data, images | Reference not found | Yes | |
| Reporting and gathering data on dose-volume dependencies of treatment outcome | Oncology | Data | 65 | Yes | |
| Calibration methods in cancer simulation models | Oncology | Procedure/method, data | 38 | ||
| Reporting HIF-1α-TG interactions | Oncology, genetics | Data | Reference not found | ||
[1]http://www.equator-network.org/reporting-guidelines/consensus-recommendations-for-the-uniform-reporting-of-clinical-trials-report-of-the-international-myeloma-workshop-consensus-panel-1/
[2]http://www.equator-network.org/reporting-guidelines/gnosis-guidelines-for-neuro-oncology-standards-for-investigational-studies-reporting-of-phase-1-and-phase-2-clinical-trials/
[3]http://www.equator-network.org/reporting-guidelines/gnosis-guidelines-for-neuro-oncology-standards-for-investigational-studies-reporting-of-surgically-based-therapeutic-clinical-trials/
[4]http://www.equator-network.org/reporting-guidelines/revised-recommendations-of-the-international-working-group-for-diagnosis-standardization-of-response-criteria-treatment-outcomes-and-reporting-standards-for-therapeutic-trials-in-acute-myeloid-leuk/
[5]http://www.equator-network.org/reporting-guidelines/clinical-trials-focusing-on-cancer-pain-educational-interventions-core-components-to-include-during-planning-and-reporting/
[6]http://www.equator-network.org/reporting-guidelines/reporting-recommendations-for-tumour-marker-prognostic-studies-remark/
[7]http://www.equator-network.org/reporting-guidelines/gene-expression-based-prognostic-signatures-in-lung-cancer-ready-for-clinical-use/
[8]http://www.equator-network.org/reporting-guidelines/translating-trial-based-molecular-monitoring-into-clinical-practice-importance-of-international-standards-and-practical-considerations-for-community-practitioners/
[9]http://www.equator-network.org/reporting-guidelines/recommendations-for-improving-the-quality-of-reporting-clinical-electrochemotherapy-studies-based-on-qualitative-systematic-review/
[10]http://www.equator-network.org/reporting-guidelines/a-common-language-in-neoadjuvant-breast-cancer-clinical-trials-proposals-for-standard-definitions-and-endpoints/
[11]http://www.equator-network.org/reporting-guidelines/consensus-guidelines-for-the-conduct-and-reporting-of-clinical-trials-in-systemic-light-chain-amyloidosis/
[12]http://www.equator-network.org/reporting-guidelines/eligibility-and-outcomes-reporting-guidelines-for-clinical-trials-for-patients-in-the-state-of-a-rising-prostate-specific-antigen-recommendations-from-the-prostate-specific-antigen-working-group/
[13]http://www.equator-network.org/reporting-guidelines/consensus-guidelines-on-plasma-cell-myeloma-minimal-residual-disease-analysis-and-reporting/
[14]http://www.equator-network.org/reporting-guidelines/diagnosis-and-management-of-acute-myeloid-leukemia-in-adults-recommendations-from-an-international-expert-panel-on-behalf-of-the-european-leukemianet/
[15]http://www.equator-network.org/reporting-guidelines/definitions-methodological-and-statistical-issues-for-phase-3-clinical-trials-in-chronic-myeloid-leukemia-a-proposal-by-the-european-leukemianet/
[16]http://www.equator-network.org/reporting-guidelines/a-reporting-guideline-for-clinical-platelet-transfusion-studies-from-the-best-collaborative/
[17]http://www.equator-network.org/reporting-guidelines/head-neck-and-brain-tumor-embolization-guidelines/
[18]http://www.equator-network.org/reporting-guidelines/evaluation-of-response-after-pre-operative-radiotherapy-in-soft-tissue-sarcomas-the-european-organisation-for-research-and-treatment-of-cancer-soft-tissue-and-bone-sarcoma-group-eortc-stbsg-and-ima/
[19]http://www.equator-network.org/reporting-guidelines/metastasis-reporting-and-data-system-for-prostate-cancer-practical-guidelines-for-acquisition-interpretation-and-reporting-of-whole-body-magnetic-resonance-imaging-based-evaluations-of-multiorgan-i/
[20]http://www.equator-network.org/reporting-guidelines/standardization-of-pathologic-evaluation-and-reporting-of-postneoadjuvant-specimens-in-clinical-trials-of-breast-cancer-recommendations-from-an-international-working-group/
[21]http://www.equator-network.org/reporting-guidelines/the-standard-of-reporting-of-health-related-quality-of-life-in-clinical-cancer-trials/
[22]http://www.equator-network.org/reporting-guidelines/setting-the-bar-in-phase-ii-trials-the-use-of-historical-data-for-determining-gono-go-decision-for-definitive-phase-iii-testing/
[23]http://www.equator-network.org/reporting-guidelines/eliciting-the-childs-voice-in-adverse-event-reporting-in-oncology-trials-cognitive-interview-findings-from-the-pediatric-patient-reported-outcomes-version-of-the-common-terminology-criteria-for-adv/
[24]http://www.equator-network.org/reporting-guidelines/missing-covariate-data-within-cancer-prognostic-studies-a-review-of-current-reporting-and-proposed-guidelines/
[25]http://www.equator-network.org/reporting-guidelines/guidelines-for-reporting-case-series-of-tumours-of-the-colon-and-rectum/
[26]http://www.equator-network.org/reporting-guidelines/reporting-magnetic-resonance-imaging-in-men-on-active-surveillance-for-prostate-cancer-the-precise-recommendations-a-report-of-a-european-school-of-oncology-task-force/
[27]http://www.equator-network.org/reporting-guidelines/do-the-media-provide-transparent-health-information-a-cross-cultural-comparison-of-public-information-about-the-hpv-vaccine/
[28]http://www.equator-network.org/reporting-guidelines/research-reporting-standards-for-radioembolization-of-hepatic-malignancies/
[29]http://www.equator-network.org/reporting-guidelines/transcatheter-therapy-for-hepatic-malignancy-standardization-of-terminology-and-reporting-criteria/
[30]http://www.equator-network.org/reporting-guidelines/research-reporting-standards-for-image-guided-ablation-of-bone-and-soft-tissue-tumors/
[31]http://www.equator-network.org/reporting-guidelines/reporting-standards-for-percutaneous-thermal-ablation-of-renal-cell-carcinoma/
[32]http://www.equator-network.org/reporting-guidelines/research-reporting-standards-for-percutaneous-vertebral-augmentation/
[33]http://www.equator-network.org/reporting-guidelines/image-guided-tumor-ablation-standardization-of-terminology-and-reporting-criteria-a-10-year-update/
[34]http://www.equator-network.org/reporting-guidelines/irreversible-electroporation-ire-standardization-of-terminology-and-reporting-criteria-for-analysis-and-comparison/
[35]http://www.equator-network.org/reporting-guidelines/the-lessons-of-quantec-recommendations-for-reporting-and-gathering-data-on-dose-volume-dependencies-of-treatment-outcome/
[36]http://www.equator-network.org/reporting-guidelines/calibration-methods-used-in-cancer-simulation-models-and-suggested-reporting-guidelines/
[37]http://www.equator-network.org/reporting-guidelines/transcription-factor-hif1a-downstream-targets-associated-pathways-polymorphic-hypoxia-response-element-hre-sites-and-initiative-for-standardization-of-reporting-in-scientific-literature/
A version of Table 3 with active links is provided online as Supplementary Table 1.