lack of “statistically significant” association does not exclude causality

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Letters to the Editor Lack of ‘‘statistically significant’’ association does not exclude causality To the Editor: This series of four systematic reviews aimed to evaluate the causal relationships between several occupational fac- tors and low back pain [1–4]. The criteria for the interpre- tation of causality are based on the well-known ‘‘aspects of association’’ discussed by Bradford-Hill. The authors used five ‘‘criteria’’ in their analysis: statistical association; dose-response relationship; experimental evidence; tempo- ral relationship; and biological plausibility. In the selection of literature the authors did, however, exclude reports on basic sciences and biomechanics, and only studies with at least 30 subjects were included. All exposures under inves- tigation were related to biomechanical and physiological factors. This limitation to epidemiologic studies excludes a huge amount of experimental laboratory studies that have shown evidence of short-term effects between mechanical exposures and outcomes related to low back pain, when evaluated by these five aspects of causality. In addition, ep- idemiologic studies can hardly provide a logical conclusion on biological plausibility, whereas some biological expla- nations were borne in mind while planning the epidemio- logic study or discussed in the article. Conclusions such as ‘‘It is unlikely that awkward occu- pational postures are independently causative of LBP in the populations of workers studied’’ are obviously incorrect be- cause they are based on a very mechanical comparison of studies with different designs, populations, and methods. The correct conclusion could be that the information on the evidence of causality in these studies, performed in in- dustrial countries, is insufficient. In agricultural work in de- veloping countries, where women work for 12 hours a day, the results would obviously be completely different. Bradford-Hill’s ‘‘aspects’’ related to causality have often been wrongly referred to as ‘‘criteria’’ for causality. This fallacy in the interpretation of causality has been discussed in several epidemiologic articles [5]. Of the nine ‘‘aspects’’, only the temporal relationship between the cause(s) and ef- fect(s) seems to be a necessarydalthough insufficientd criterion, and none of the other aspects are either necessary or sufficient criterion for proof. It seems it is not possible to find a set of criteria or procedures that will formally prove the causality between the proposed cause(s) and effect(s) in epidemiology. Checklists and rating scales are commonly used to eval- uate the quality of original reports and the level of evidence in systematic reviews. Use of these tools should not be automatic but critical, keeping in mind that the scales and cutoff limits for decisions are arbitrary, and that there is no theoretical ground to generalize them as golden stan- dards. Causality or lack of causality cannot be concluded by scales. Neither does lack of statistical association exclude causality. Systematic reviews are highly respected as a summary of evidence on medical questions and are widely used for health policy decisions. Therefore, the authors of these reviews, and the reviewers recommending publication, should be aware of the fallacies related to the statistical inference and logic of causal conclusions in epidemiologic studies to prevent them from conveying the wrong summary statement. References [1] Wai EK, Roffey DM, Bishop P, et al. Causal assessment of occupa- tional bending or twisting and low back pain: results of a systematic review. Spine J 2010;10:76–88. [2] Roffey DM, Wai EK, Bishop P, et al. Causal assessment of awkward occupational postures and low back pain: results of a systematic review. Spine J 2010;10:89–99. [3] Roffey DM, Wai EK, Bishop P, et al. Causal assessment of occupa- tional sitting and low back pain: results of a systematic review. Spine J 2010;10:252–61. [4] Roffey DM, Wai EK, Bishop P, et al. Causal assessment of occupa- tional standing or walking and low back pain: results of a systematic review. Spine J 2010;10:262–72. [5] Ward A. The role of causal criteria in causal inferences: Bradford Hill’s ‘‘aspects of association’’. Epidemiol Perspect Innov 2009;6:2. Esa-Pekka Takala, MD, PhD Helsinki, Finland doi:10.1016/j.spinee.2010.07.008 Reply We wish to thank Dr Takala for his interest in our man- uscripts [1–8] and understand that our findings may appear counterintuitive to some readers. The starting point for undertaking these studies was the confusion surrounding the potential role that specific occu- pational physical activities might have in the development 1529-9430/$ - see front matter Ó 2010 Elsevier Inc. All rights reserved. The Spine Journal 10 (2010) 944–946

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Page 1: Lack of “statistically significant” association does not exclude causality

The Spine Journal 10 (2010) 944–946

Letters to the Editor

Lack of ‘‘statistically significant’’ association does notexclude causality

To the Editor:

This series of four systematic reviews aimed to evaluatethe causal relationships between several occupational fac-tors and low back pain [1–4]. The criteria for the interpre-tation of causality are based on the well-known ‘‘aspects ofassociation’’ discussed by Bradford-Hill. The authors usedfive ‘‘criteria’’ in their analysis: statistical association;dose-response relationship; experimental evidence; tempo-ral relationship; and biological plausibility. In the selectionof literature the authors did, however, exclude reports onbasic sciences and biomechanics, and only studies with atleast 30 subjects were included. All exposures under inves-tigation were related to biomechanical and physiologicalfactors. This limitation to epidemiologic studies excludesa huge amount of experimental laboratory studies that haveshown evidence of short-term effects between mechanicalexposures and outcomes related to low back pain, whenevaluated by these five aspects of causality. In addition, ep-idemiologic studies can hardly provide a logical conclusionon biological plausibility, whereas some biological expla-nations were borne in mind while planning the epidemio-logic study or discussed in the article.

Conclusions such as ‘‘It is unlikely that awkward occu-pational postures are independently causative of LBP in thepopulations of workers studied’’ are obviously incorrect be-cause they are based on a very mechanical comparison ofstudies with different designs, populations, and methods.The correct conclusion could be that the information onthe evidence of causality in these studies, performed in in-dustrial countries, is insufficient. In agricultural work in de-veloping countries, where women work for 12 hours a day,the results would obviously be completely different.

Bradford-Hill’s ‘‘aspects’’ related to causality have oftenbeen wrongly referred to as ‘‘criteria’’ for causality. Thisfallacy in the interpretation of causality has been discussedin several epidemiologic articles [5]. Of the nine ‘‘aspects’’,only the temporal relationship between the cause(s) and ef-fect(s) seems to be a necessarydalthough insufficientdcriterion, and none of the other aspects are either necessaryor sufficient criterion for proof. It seems it is not possible tofind a set of criteria or procedures that will formally provethe causality between the proposed cause(s) and effect(s) inepidemiology.

1529-9430/$ - see front matter � 2010 Elsevier Inc. All rights reserved.

Checklists and rating scales are commonly used to eval-uate the quality of original reports and the level of evidencein systematic reviews. Use of these tools should not beautomatic but critical, keeping in mind that the scales andcutoff limits for decisions are arbitrary, and that there isno theoretical ground to generalize them as golden stan-dards. Causality or lack of causality cannot be concludedby scales. Neither does lack of statistical associationexclude causality.

Systematic reviews are highly respected as a summary ofevidence onmedical questions and arewidely used for healthpolicy decisions. Therefore, the authors of these reviews, andthe reviewers recommending publication, should be aware ofthe fallacies related to the statistical inference and logic ofcausal conclusions in epidemiologic studies to prevent themfrom conveying the wrong summary statement.

References

[1] Wai EK, Roffey DM, Bishop P, et al. Causal assessment of occupa-

tional bending or twisting and low back pain: results of a systematic

review. Spine J 2010;10:76–88.

[2] Roffey DM, Wai EK, Bishop P, et al. Causal assessment of awkward

occupational postures and low back pain: results of a systematic

review. Spine J 2010;10:89–99.

[3] Roffey DM, Wai EK, Bishop P, et al. Causal assessment of occupa-

tional sitting and low back pain: results of a systematic review. Spine

J 2010;10:252–61.

[4] Roffey DM, Wai EK, Bishop P, et al. Causal assessment of occupa-

tional standing or walking and low back pain: results of a systematic

review. Spine J 2010;10:262–72.

[5] Ward A. The role of causal criteria in causal inferences: Bradford

Hill’s ‘‘aspects of association’’. Epidemiol Perspect Innov 2009;6:2.

Esa-Pekka Takala, MD, PhDHelsinki, Finland

doi:10.1016/j.spinee.2010.07.008

Reply

We wish to thank Dr Takala for his interest in our man-uscripts [1–8] and understand that our findings may appearcounterintuitive to some readers.

The starting point for undertaking these studies was theconfusion surrounding the potential role that specific occu-pational physical activities might have in the development