The journal of pain : official journal of the American Pain Society
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Thorough assessment and reporting of adverse events (AEs) facilitates a detailed understanding of a treatment's risk-benefit profile. Although the Consolidated Standards of Reporting Trials (CONSORT) 2004 statement provides recommendations regarding AE reporting, adherence to these standards is often inadequate. We investigated AE reporting in clinical trials of intravenous and invasive pain treatments published in 6 major anesthesiology and pain journals between 2000 to 2003 and 2006 to 2012. ⋯ Anesthesiology and pain journals were similar in AE reporting quality, although industry-sponsored trials reported more AE information than nonindustry sponsored trials. Improvement is needed in AE reporting in analgesic clinical trials. The CONSORT checklist and ACTTION AE recommendations can assist investigators and editors in improving clinical trial transparency and quality.
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Randomized Controlled Trial
Exploring what factors mediate treatment effect: Example of the STarT Back study high-risk intervention.
Interventions developed to improve disability outcomes for low back pain (LBP) often show only small effects. Mediation analysis was used to investigate what led to the effectiveness of the STarT Back trial, a large primary care-based trial that treated patients consulting with LBP according to their risk of a poor outcome. The high-risk subgroup, randomized to receive either psychologically-informed physiotherapy (n = 93) or current best care (n = 45), was investigated to explore pain-related distress and pain intensity as potential mediators of the relationship between treatment allocation and change in disability. ⋯ Outcome was measured using the Roland-Morris Disability Questionnaire. Change in pain-related distress and pain intensity were found to have a significant mediating effect of .25 (standardized estimate, bootstrapped 95% confidence interval, .09-.39) on the relationship between treatment group allocation and change in disability outcome. This study adds to the evidence base of treatment mediation studies in pain research and the role of distress in influencing disability outcome in those with complex LBP.
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Barriers to clinical trial recruitment can delay study completion, potentially resulting in increased costs and an unrepresentative sample. In the current study of 150 participants with chronic pain, we used a computerized adaptive choice-based conjoint survey that included 8 characteristics that may affect enrollment in pharmacologic pain treatment trials (ie, treatment allocation, frequency of pain ratings, treatment administration method, current medications, number of study visits, availability of evening and weekend visits, invasiveness of laboratory procedures, payment). ⋯ The fourth most important characteristic was number of study visits (13%), with participants preferring fewer in-person visits and more phone contacts. Understanding the preferences of potential participants is an important step toward enhancing enrollment in pain treatment trials.
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Pediatric persistent pain is associated with poorer physical and psychosocial functioning in children, as well as immediate and long-term societal costs. Onset typically occurs in early adolescence, suggesting that late childhood is a key window for identifying potential intervention targets before pain symptoms become entrenched. ⋯ Key factors at 10 to 11 years that uniquely predicted parent-reported pain problems at 12 to 13 years were frequency of previous pain (1-3 times weekly: odds ratio [OR] = 7.49; 95% confidence interval [CI], 4.3-13.0; 4-7 times weekly: OR = 17.8; 95% CI, 8.7-36.5) and sleep difficulties (OR = 1.86; 95% CI, 1.16-2.97). This study highlights the importance of early intervention for persistent pain in childhood, because pain complaints in late childhood tend to persist into early adolescence.
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The current study examined the relationship between perceived injustice and attentional bias (AB) toward pain among individuals with chronic low back pain asked to perform and appraise the pain and difficulty of a standardized set of common physical activities. A pictorial dot-probe task assessed AB toward pain stimuli (ie, pain faces cueing pain), after which participants performed the physical tasks. Participants also rated face stimuli in terms of pain, sadness, and anger expression. ⋯ Exploratory analyses indicated that participants with higher levels of perceived injustice rated stimulus faces as sadder and angrier; no such differences emerged for pain ratings. To our knowledge, this is the first study to examine the association between perceived injustice and AB toward pain, as well as perceived injustice and in vivo appraisals of common physical activity. Results extend existing literature and suggest that attentional and potential interpretive bias should be considered in future research.