Causality Assessment: How do we know that meditation is the cause?
In the Varieties of Contemplative Experience study, causal attribution to meditation was assessed according to the causality assessment criteria that regulatory agencies such as the World Health Organization (WHO), the Federal Drug Administration (FDA), and the National Institutes of Health (NIH) use to make health policy decisions (Agbabiaka, Savovic, & Ernst, 2008; NIH, 2016; Turner, 1984; WHO, 2016). These criteria are designed to assess causality of treatment-related adverse events in individual cases in the absence of prospective or epidemiological (base rate) data. Thirteen standard causality criteria typically include:
7) re-challenge,
8) specificity,
9-11) three types of consistency,
12) biological gradient
13) linkage to known biological mechanisms
1) prior published reports,
2) expert judgment,
3) subjective attribution,
4) temporal proximity (challenge),
5) exacerbation,
6) de-challenge,
(Agbabiaka et al., 2008; Gallagher et al., 2011; Hill, 1965, 2015; Naranjo, 1986; Naranjo, Busto, & Sellers, 1982; Naranjo et al., 1981; Theophile et al., 2010).
The Varieties of Contemplative Experiencet study assessed the first 11 criteria. Prior published reports included case reports or studies about unusual or challenging meditation-related experiences in the scientific or clinical literature. Expert judgment was derived from interviews with 32 meditation teachers and clinicians. The following six criteria were assessed as part of the demographics and attributes follow-up questionnaire or, in the case of non-responders, extracted from the interview transcript:
causal attribution to meditation by the subject (subjective attribution);
temporal proximity to (either during or following) meditation practice (challenge);
exacerbation of pre-existing symptoms following meditation;
occurrence on more than one occasion (consistency);
decrease when practice is reduced (de-challenge);
re-appearance when practice is repeated (re-challenge).
A causality score was calculated as the sum of endorsements of these six criteria. Using standard guidelines (OHRP, 2007), a score of two or greater, signifying “possibly related,” was the cutoff for inclusion.
Specificity—or the likelihood of a cause other than meditation—was evaluated at two levels. If an alternative cause such as medical illness or pre-existing psychological conditions could have wholly accounted for the experiences reported, then these subjects failed to meet causality criteria and were excluded. In the remaining practitioners, specific experiences that could not be directly linked to meditation or that were attributed to other causes (e.g., drug use, prior psychiatric or medical history, or a period in life prior to learning meditation) were not coded for phenomenology (see below: Phenomenology coding).
The consistency criterion was assessed at three levels: intra-subjective, inter-subjective, and cross-modal. Intra-subjective consistency refers to the same or a similar experience occurring in close temporal proximity (during or following) to meditation on more than one occasion within the same individual. Inter-subjective consistency refers to the same or a similar experience occurring during or following meditation in multiple individuals. Cross-modal consistency refers to different classes of sources (practitioners and experts) reporting the same or a similar experience during or following meditation (i.e. source triangulation).
Prior published reports: See Bibliography for up-to-date count of published reports of meditation-related difficulties in the scientific, clinical and medical literature. Current count(as of 9.19.19) = 80.
Expert judgment was derived from interviews with 32 meditation teachers and clinicians who reported 56 categories of meditation-related experiences that they had observed in their students.
Through the causality assessment section of the demographic and attributes follow-up questionnaire, practitioners reported on six causality criteria: subjective attribution, temporal proximity (challenge), exacerbation, consistency, de-challenge, and re-challenge. Meditation practitioners met an average of four causality criteria (mean = 4.2 ±1.1 range = 2-6;), with more than half (60%) meeting four, five, or all six criteria, well-exceeding the minimum cutoff of two that standard guidelines use to warrant further investigation (OHRP, 2007).
The consistency criterion was assessed on three levels: In the current study, 88% of the practitioner sample met the intra-subjective consistency criterion, indicating that they reported having the same or a similar experience during or following meditation on multiple occasions.
Inter-subjective consistency was assessed through evaluating how many practitioners reported each category (see Table 4 above). Each category of experience was reported by an average of 20 practitioners, indicating that the same or a similar experience occurring in temporal proximity to meditation was reported by multiple individuals. Cross-modal consistency was assessed by comparing the phenomenology reported in practitioner interviews to the phenomenology reported in expert interviews. Fifty-six of 59 (95%) categories of experience were reported by both practitioners and experts, with an average of 20 (SD = 10.2) practitioners and 4.6 (SD= 4.3) experts reporting each category. As reported above, similarities between practitioner and experts reports were not impacted by the 11 participants who provided both practitioner and expert interviews.
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