{"doi":"10.1111/bju.16028","title":"Guidelines for reporting observational research in urology: the importance of clear reference to causality","abstract":"As statistical editors and reviewers, we have noticed that observational research papers submitted for publication often share a common set of problems with respect to the issue of causality. Causality can be conceptualised in counterfactual terms: would the outcome be different if we change what we do? For instance, we say that smoking causes cancer because if we reduce smoking, we reduce cancer; conversely, even though ice cream sales closely track the rate of shark bites, we avoid a causal conclusion because banning ice cream would not make ocean swimming any safer. Here we suggest guidelines for reporting of observational studies where investigators calculate statistical associations between an exposure, such as a drug, a change in surgical technique or a lifestyle factor like smoking or diet, and an outcome, such as cancer diagnosis or cancer progression. The core issue is that authors all too often avoid any explicit reference to causal mechanisms and causal inference but then still try to draw causal conclusions. We repeatedly see investigators declare somberly in the methods section that a study aims merely to ‘derive statistical associations’ but then report results or make recommendations that clearly imply causality: a drug is said to ‘reduce risk’, a surgical technique to ‘improve outcome’ or a recommendation made that patients be counselled to change lifestyle so as to ‘prevent cancer’. Then in response to criticism, authors sometimes deny in their rebuttal letters (and elsewhere) that their language implies a causal conclusion. Assessing statistical association is easy and determining causation is hard; yet, while associations are sometimes of research interest, understanding causality is necessary to provide solutions that can improve patient outcomes. Our anecdotal experience has recently been corroborated by systematic reviews of the language used by authors of observational studies: ‘one section might be carefully phrased in terms of association while the other presented causal language’; ‘some authors (inappropriately) jumped to recommending acting on the findings’ despite reporting only statistical associations [1, 2]. Of particular note, remarkably few papers explicitly used the word ‘cause’. One well-known commentary argues that avoidance of causal language has simply become a reflexive response to the difficulties of causal inference, though, naturally, avoiding a subject does not aid scientific progress [3]. We will use a hypothetical example to avoid singling out individual authors for what is such a common problem, although the example is closely modelled on a published paper from outside the field of urology. Imagine a study on statins and rates of overdiagnosis following PSA screening. A typical report would introduce the hypothesis in terms of whether ‘the use of statins is associated with rates of prostate cancer overdiagnosis’. The authors might report lower rates of overdiagnosis in statin users and then rapidly switch to causal language: ‘statin use shows protective effects on overdiagnosis. Low-grade cancers in particular were reduced with the use of statins’. A caveat is typically then buried deep in the discussion section (‘we cannot fully establish a causal relationship’) and the conclusion is generally vague (a ‘decrease in overdiagnosis with the use of statins’), something which protects the authors from criticism while allowing them to imply that their paper has causal implications. There is no attempt to identify causal pathways, let alone conduct analyses to explore those pathways. Causal pathways are critical because they determine the implications of the findings for clinical practice. If statins reduce overdiagnosis directly, for instance, through an antineoplastic mechanism, we might more strongly recommend statins to men who are undergoing PSA screening. The clinical consequences would be very different if the effects of statins are indirect. For instance, if statins reduce overdi","journal":"British Journal of Urology","year":2023,"id":380868,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":4,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9511,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":485721,"name":"Melissa Assel","orcid":null,"position":1,"is_corresponding":false},{"id":592047,"name":"Rodney L. Dunn","orcid":"0000-0002-4148-8538","position":2,"is_corresponding":false},{"id":380389,"name":"Emily C. Zabor","orcid":"0000-0002-1402-4498","position":3,"is_corresponding":false},{"id":45522,"name":"Michael W. Kattan","orcid":"0000-0002-3840-4161","position":4,"is_corresponding":false},{"id":6409,"name":"Maarten van Smeden","orcid":"0000-0002-5529-1541","position":5,"is_corresponding":false},{"id":104021,"name":"Darren Dahly","orcid":"0000-0003-0110-324X","position":6,"is_corresponding":false},{"id":72212,"name":"Andrew J. Vickers","orcid":"0000-0003-1525-6503","position":0,"is_corresponding":true}],"reference_count":18,"raw_metadata":null,"created_at":"2026-07-19T01:17:04.905707Z","pmid":"37208953","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}