Pain
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Randomized Controlled Trial
Implicit associations between pain and self-schema in patients with chronic pain.
Chronic pain often interferes with daily functioning, and may become a threat to an individual's sense of self. Despite the development of a recent theoretical account focussing upon the relationship between the presence of chronic pain and a person's self, research investigating this idea is limited. In the present study we aimed to (1) compare the strength of association between self- and pain schema in patients with chronic pain and healthy control subjects and (2) research whether the strength of association between self- and pain-schema is related to particular pain-related outcomes and individual differences of patients with chronic pain. ⋯ Results indicated that the pain- and self-schema were more strongly associated in patients with chronic pain than in healthy control subjects. Second, results indicated that, in patients with chronic pain, a stronger association between self- and pain-schema, as measured with the IAT, is related to a heightened level of pain severity, pain suffering, anxiety, and helplessness. Current findings give first support for the use of an IAT to investigate the strength of association between self- and pain-schema in patients with chronic pain and suggest that pain therapies may incorporate techniques that intervene on the level of self-pain enmeshment.
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There has been a tension between the needs of regulators and industry to demonstrate that interventions are effective and safe, and the needs of professionals to understand how well interventions will work for their patients, and patients to understand what might work for them as individuals. The custom has been to focus on statistical outcomes based on average results, but in-depth analysis based on outcomes obtained by individual patients demonstrates that few are average. ⋯ This changes how benefit and risk are seen; nonresponders should stop treatments that don't work and not, therefore, be exposed to risks, while responders have very large benefits to offset against rare but potentially serious harm. This alternative view, patient-centred and practice-orientated, has major implications for clinical practice, how and why we do clinical trials and how they are designed, how health economic evaluations are done, for decisions made by regulatory and other bodies, and for the theory and practice of evidence-based medicine.
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The National Institutes of Health released the trial registry ClinicalTrials.gov in 2000 to increase public reporting and clinical trial transparency. This systematic review examined whether registered primary outcome specifications (POS; ie, definitions, timing, and analytic plans) in analgesic treatment trials correspond with published POS. Trials with accompanying publications (n = 87) were selected from the Repository of Registered Analgesic Clinical Trials (RReACT) database of all postherpetic neuralgia, diabetic peripheral neuropathy, and fibromyalgia clinical trials registered at ClinicalTrials.gov as of December 1, 2011. ⋯ At best, POS discrepancies may be attributable to insufficient registry requirements, carelessness (eg, failing to report PO assessment timing), or difficulty uploading registry information. At worst, discrepancies could indicate investigator impropriety (eg, registering imprecise PO ["pain"], then publishing whichever pain assessment produced statistically significant results). Improvements in PO registration, as well as journal policies requiring consistency between registered and published PO descriptions, are needed.