A multisite feasibility randomized clinical trial of mindfulness-based resilience training for aggression, stress, and health in law enforcement officers.

BACKGROUND: Law enforcement officers (LEOs) are exposed to significant stressors that can impact their mental health, increasing risk of posttraumatic stress disorder, burnout, at-risk alcohol use, depression, and suicidality. Compromised LEO health can subsequently lead to aggression and excessive use of force. Mindfulness training is a promising approach for high-stress populations and has been shown to be effective in increasing resilience and improving mental health issues common among LEOs. METHODS: This multi-site, randomized, single-blind clinical feasibility trial was intended to establish optimal protocols and procedures for a future full-scale, multi-site trial assessing effects of mindfulness-based resilience training (MBRT) versus an attention control (stress management education [SME]) and a no-intervention control, on physiological, attentional, and psychological indices of stress and mental health. The current study was designed to enhance efficiency of recruitment, engagement and retention; optimize assessment, intervention training and outcome measures; and ensure fidelity to intervention protocols. Responsiveness to change over time was examined to identify the most responsive potential proximate and longer-term assessments of targeted outcomes. RESULTS: We observed high feasibility of recruitment and retention, acceptability of MBRT, fidelity to assessment and intervention protocols, and responsiveness to change for a variety of putative physiological and self-report mechanism and outcome measures. CONCLUSIONS: Results of this multi-site feasibility trial set the stage for a full-scale, multi-site trial testing the efficacy of MBRT on increasing LEO health and resilience, and on decreasing more distal outcomes of aggression and excessive use of force that would have significant downstream benefits for communities they serve. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03784846 . Registered on December 24th, 2018.

Implementation of Virtual Interprofessional Observed Structured Clinical Encounters (OSCEs): A Pilot Study.

This pilot study was designed to investigate the feasibility of incorporating validated McMaster-Ottawa Team Observed Structured Clinical Encounters (TOSCEs) as a behavioral assessment in an interprofessional education (IPE) program using Zoom Communications. First- and second-year students from 11 health professional programs (e.g., audiology, dental hygiene, graduate psychology, healthcare administration and leadership, occupational therapy, pharmacy, physical therapy and athletic training, and physician assistant studies) at a single university participated and were assessed on the four Interprofessional Education Collaborative (IPEC) core competencies. Students completed three McMaster-Ottawa TOSCE stations (20 mins per station), followed by a large group debriefing for all participants to discuss the process and provide feed¬back. A validated, abbreviated version of the McMaster-Ottawa scoring rubric was utilized by faculty observers, and individual student scores were submitted using a Google form. Kruskal Wallis tests were used to analyze student performance related to the IPEC core competencies to deter¬mine whether significant differences existed between mean performance scores as compared by year in program (first year vs. second), and between case types. Kruskal-Wallis tests suggested differences on the collaborative patient performance item between the pediatric and diabetes cases only. There were no significant differences in performance across academic year in health professional programs, p > 0.05. Qualitative feedback highlighted the timely telehealth approach to collaborative practice and effective delivery of the interprofessional (IP) OSCE event across all of the student focus groups. The virtual IP OSCEs were feasible and recommended as a valuable IPE initiative at our institution.

Measuring the Efficacy of a Foundational Interprofessional Education Course Using the Attitudes Towards Health Care Teams Scale.

BACKGROUND: Interprofessional education (IPE) has been widely embraced over the past several years, in a variety of ways among different institutions. Due to heterogeneity of IPE programming, it has been challenging to determine the efficacy of pre-professional IPE across the field. However, individual institutions need to assess efficacy of their own IPE programming. The purpose of this study was to assess whether the interprofessional competence course (IPC) at Pacific University was effective as determined by changes in pre- to post-course scores on the Attitudes Towards Health Care Teams Scale (ATHCTS). METHODS: First-year students in the College of Health Professions completed the ATHCTS on the first and last days of the IPC course. Descriptive and inferential analyses were completed using SPSS. RESULTS: Student cohorts from both 2016 (n=423) and 2017 (n=445) demonstrated significant improvements in scores on the ATHCTS (p<0.01). Changes in attitudes differed as a function of gender, with men demonstrating a larger improvement (p=0.013). Changes in attitudes did not differ as a function of professional program. CONCLUSIONS: The IPC course demonstrated effective content delivery as measured by changes in the ATHCTS scores.

Differential impact of mindfulness practices on aggression among law enforcement officers.

OBJECTIVES: Home-based mindfulness practice is a common component of formal mindfulness training (MT) protocols. Obtaining objective data from home-based mindfulness practice is challenging. Interpreting associations between home-based mindfulness practice and clinically impactful outcomes is complicated given the variability in recommendations in length, frequency, and type of practice. In this exploratory study, adherence to home-based practices of Mindfulness-Based Resilience Training (MBRT) was studied in order to evaluate associations with clinical outcomes. METHODS: Home practices from 24 (92% male, non-Hispanic white, aged M = 43.20 years) law enforcement officers (LEOs) from the urban Pacific Northwest enrolled in a feasibility and efficacy trial of MBRT were studied using an objective tracking device and self-report data. Outcomes included adherence to home-based mindfulness practices and self-reported aggression. RESULTS: Participants completed 59.12% of the frequency amount of practice assigned in the MBRT curriculum. Frequency of practice was associated with decreased aggression, adjusted R 2 = .41, F(3,23) = 6.14, p = .004. Duration of practice also predicted decreased aggression, adjusted R 2 = .33, F(3,23) = 4.76, p = .011. CONCLUSIONS: Home-based MBRT practices for LEOs, even at low rates of adherence, may reduce aggression. MTs may show beneficial effects for other populations presented with challenges to engage in regular MT practices.

Mindfulness Training, Implicit Bias, and Force Response Decision-making.

OBJECTIVE: The goal of this study was to assess the preliminary efficacy of a Mindfulness-Based Training (Mindfulness-based Resilience Training; MBRT) in improving weapon identification among Law Enforcement Officers (LEOs). METHODS: Participants (N = 61) were randomly assigned to either MBRT or a no-intervention control group (NIC). A self-report questionnaire assessing mindfulness and a computerized measure assessing implicit stereotype reliance were administered at baseline, post-training, and three months following intervention completion. We also collected information about meditation practice outside of the training for LEOs in the MBRT group. RESULTS: Inferential analyses yielded improvements in mindfulness in the MBRT group compared to NIC. Analyses did not provide evidence for implicit stereotype reliance at baseline and therefore did not yield a significant impact of MBRT versus NIC on implicit stereotype reliance, ps > .05; however, participants across both conditions exerted more control when responding to Black male targets compared to White male targets, F(1,74) = 3.98, p = .05, 95% CI [-.05, -.01], d = .36. CONCLUSIONS: Our results do not provide evidence for the impact of MBRT on weapon identification, but do suggest that LEOs exerted more effort when responding to images of Black males compared to White males. We discuss recommendations for future clinical trials assessing implicit stereotype reliance, viz., that researchers utilize measures more sensitive to a wider range of LEO samples and with higher ecological validity, and we discuss potential reasons why our results do not align with past research.

A Brief Mindfulness-Based Intervention for Primary Care Physicians: A Pilot Randomized Controlled Trial.

Primary care physicians experience high rates of burnout, which results in diminished quality of life, poorer quality of care, and workforce attrition. In this randomized controlled trial, our primary aim was to examine the impact of a brief mindfulness-based intervention (MBI) on burnout, stress, mindfulness, compassion, and resilience among physicians. A total of 33 physicians completed the baseline assessment and were randomized to the Mindful Medicine Curriculum (MMC; n = 17) or waitlist control group (n = 16). Participants completed self-report measures at baseline, post-MBI, and 3-month follow-up. We also analyzed satisfaction with doctor communication (DCC) and overall doctor rating (ODR) data from patients of the physicians in our sample. Participants in the MMC group reported significant improvements in stress (P < .001), mindfulness (P = .05), emotional exhaustion (P = .004), and depersonalization (P = .01) whereas in the control group, there were no improvements on these outcomes. Although the MMC had no impact on patient-reported DCC or ODR, among the entire sample at baseline, DCC and ODR were significantly correlated with several physician outcomes, including resilience and personal achievement. Overall, these findings suggest that a brief MBI can have a positive impact on physician well-being and potentially enhance patient care.

Mindfulness-based resilience training to reduce health risk, stress reactivity, and aggression among law enforcement officers: A feasibility and preliminary efficacy trial.

The primary objective of this study was to assess feasibility and gather preliminary outcome data on Mindfulness-Based Resilience Training (MBRT) for law enforcement officers. Participants (n = 61) were randomized to either an 8-week MBRT course or a no intervention control group. Self-report and physiological data were collected at baseline, post-training, and three months following intervention completion. Attendance, adherence, post-training participant feedback, and interventionist fidelity to protocol all demonstrated feasibility of MBRT for law enforcement officers. Compared to no intervention controls, MBRT participants experienced greater reductions in salivary cortisol, self-reported aggression, organizational stress, burnout, sleep disturbance, and reported increases in psychological flexibility and non-reactivity at post-training; however, group differences were not maintained at three-month follow-up. This initial randomized trial suggests MBRT is a feasible intervention. Outcome data suggest MBRT targets key physiological, psychological, and health risk factors in law enforcement officers, consistent with the potential to improve officer health and public safety. However, follow-up training or "booster" sessions may be needed to maintain training gains. A fully powered longitudinal randomized trial is warranted.

Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: ACTTION systematic review.

OBJECTIVE: To examine whether primary reports of randomized clinical trials (RCTs) in six high-impact, general medical journals reported (1) whether or not a Data Monitoring Committee/Data and Safety Monitoring Board (DMC/DSMB) was used and (2) the composition of the responsibilities of the reported DSMB/DMCs. STUDY DESIGN AND SETTING: Systematic review of RCTs published in 2014 in Annals of Internal Medicine, BMJ, NEJM, JAMA, JAMA Internal Medicine, and Lancet. RESULTS: Of the 294 articles identified, 174 (59%) mentioned using a DMC/DSMB. Of these 174, 126 (72%) indicated at least one responsibility of the DMC/DSMB, 26% listed the names of the DMC/DSMB members, and another 14% listed both their names and affiliations. Only one article stated that a DSMB was not used. The remaining 119 articles did not report whether or not a DMC/DSMB was used, although 59 had previously stated in a clinical trials registry entry or a published protocol that a DMC/DSMB was to be used. CONCLUSIONS: Considering the major role that DMC/DSMBs play in protecting participant safety, data quality, and interim analyses in RCTs, we recommend that authors of publications of RCTs report whether a DMC/DSMB was used and the responsibilities and members of DMC/DSMBs to increase transparency regarding study conduct.

ROLE OF RESILIENCE IN MINDFULNESS TRAINING FOR FIRST RESPONDERS.

First responders are exposed to critical incidents and chronic stressors that contribute to a higher prevalence of negative health outcomes compared to other occupations. Psychological resilience, a learnable process of positive adaptation to stress, has been identified as a protective factor against the negative impact of burnout. Mindfulness-Based Resilience Training (MBRT) is a preventive intervention tailored for first responders to reduce negative health outcomes, such as burnout. This study is a secondary analysis of law enforcement and firefighters samples to examine the mechanistic role of psychological resilience on burnout. Results indicated that changes in resilience partially mediated the relationship between mindfulness and burnout, and that increased mindfulness was related to increased resilience (b = .41, SE = .11, p < .01), which in turn was related to decreased burnout (b = -.25, SE = .12, p = .03). The bootstrapped confidence interval of the indirect effect did not contain zero [95% CI; -.27, -.01], providing evidence for mediation. Limitations and implications are discussed.

Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review.

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. We examined whether AE reporting improved after publication of the 2004 CONSORT recommendations and also comprehensively reviewed AE assessment using the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) AE reporting recommendations. No improvement was found overall in CONSORT harms reporting scores from pre- to postpublication of the CONSORT recommendations, with only 5 of 10 fulfilled on average. AE reporting assessed using the ACTTION coding manual was generally inadequate, and 8% of articles failed to report any AE information at all. 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. PERSPECTIVE: This systematic review of AE reporting in intravenous and invasive pain treatment trials shows that little improvement has been made since the 2004 CONSORT harms reporting guidelines. Better assessment and reporting of treatment AEs is necessary to understand the full clinical effect of intravenous and invasive treatments.

Pain intensity rating training: results from an exploratory study of the ACTTION PROTECCT system.

Clinical trial participants often require additional instruction to prevent idiosyncratic interpretations regarding completion of patient-reported outcomes. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership developed a training system with specific, standardized guidance regarding daily average pain intensity ratings. A 3-week exploratory study among participants with low-back pain, osteoarthritis of the knee or hip, and painful diabetic peripheral neuropathy was conducted, randomly assigning participants to 1 of 3 groups: training with human pain assessment (T+); training with automated pain assessment (T); or no training with automated pain assessment (C). Although most measures of validity and reliability did not reveal significant differences between groups, some benefit was observed in discriminant validity, amount of missing data, and ranking order of least, worst, and average pain intensity ratings for participants in Group T+ compared with the other groups. Prediction of greater reliability in average pain intensity ratings in Group T+ compared with the other groups was not supported, which might indicate that training produces ratings that reflect the reality of temporal pain fluctuations. Results of this novel study suggest the need to test the training system in a prospective analgesic treatment trial.

Deficiencies in reporting of statistical methodology in recent randomized trials of nonpharmacologic pain treatments: ACTTION systematic review.

OBJECTIVE: The goal of this study was to assess the quality of reporting of statistical methods in randomized clinical trials (RCTs), including identification of primary analyses, missing data accommodation, and multiplicity adjustment, in studies of nonpharmacologic, noninterventional pain treatments (e.g., physical therapy, cognitive behavioral therapy, acupuncture, and massage). STUDY DESIGN: Systematic review of 101 articles reporting RCTs of pain treatments that were published between January 2006 and June 2013 in the European Journal of Pain, the Journal of Pain, and Pain. SETTING: Systematic review. RESULTS: Sixty-two percent of studies identified a primary outcome variable, 46% identified a primary analysis, and of those with multiple primary analyses, only 21% adjusted for multiplicity. Slightly over half (55%) of studies reported using at least one method to accommodate missing data. Only four studies reported prespecifying at least one of these four study methods. CONCLUSION: This review identified deficiencies in the reporting of primary analyses and methods to adjust for multiplicity and accommodate missing data in articles disseminating results of nonpharmacologic, noninterventional trials. Investigators should be encouraged to indicate whether their analyses were prespecified and to clearly and completely report statistical methods in clinical trial publications to maximize the interpretability of trial results.

Female peers in small work groups enhance women's motivation, verbal participation, and career aspirations in engineering.

For years, public discourse in science education, technology, and policy-making has focused on the "leaky pipeline" problem: the observation that fewer women than men enter science, technology, engineering, and mathematics fields and more women than men leave. Less attention has focused on experimentally testing solutions to this problem. We report an experiment investigating one solution: we created "microenvironments" (small groups) in engineering with varying proportions of women to identify which environment increases motivation and participation, and whether outcomes depend on students' academic stage. Female engineering students were randomly assigned to one of three engineering groups of varying sex composition: 75% women, 50% women, or 25% women. For first-years, group composition had a large effect: women in female-majority and sex-parity groups felt less anxious than women in female-minority groups. However, among advanced students, sex composition had no effect on anxiety. Importantly, group composition significantly affected verbal participation, regardless of women's academic seniority: women participated more in female-majority groups than sex-parity or female-minority groups. Additionally, when assigned to female-minority groups, women who harbored implicit masculine stereotypes about engineering reported less confidence and engineering career aspirations. However, in sex-parity and female-majority groups, confidence and career aspirations remained high regardless of implicit stereotypes. These data suggest that creating small groups with high proportions of women in otherwise male-dominated fields is one way to keep women engaged and aspiring toward engineering careers. Although sex parity works sometimes, it is insufficient to boost women's verbal participation in group work, which often affects learning and mastery.

Assay sensitivity of pain intensity versus pain relief in acute pain clinical trials: ACTTION systematic review and meta-analysis.

UNLABELLED: The magnitude of the effect size of an analgesic intervention can be influenced by several factors, including research design. A key design component is the choice of the primary endpoint. The purpose of this meta-analysis was to compare the assay sensitivity of 2 efficacy paradigms: pain intensity (calculated using summed pain intensity difference [SPID]) and pain relief (calculated using total pain relief [TOTPAR]). A systematic review of the literature was performed to identify acute pain studies that calculated both SPIDs and TOTPARs within the same study. Studies were included in this review if they were randomized, double-blind, placebo-controlled investigations involving medications for postsurgical acute pain and if enough data were provided to calculate TOTPAR and SPID standardized effect sizes. Based on a meta-analysis of 45 studies, the mean standardized effect size for TOTPAR (1.13) was .11 higher than that for SPID (1.02; P = .01). Mixed-effects meta-regression analyses found no significant associations between the TOTPAR - SPID difference in standardized effect size and trial design characteristics. Results from this review suggest that for acute pain studies, utilizing TOTPAR to assess pain relief may be more sensitive to treatment effects than utilizing SPID to assess pain intensity. PERSPECTIVE: The results of this meta-analysis suggest that TOTPAR may be more sensitive to treatment effects than SPIDs are in analgesic trials examining acute pain. We found that standardized effect sizes were higher for TOTPAR compared to SPIDs.

Quality of pain intensity assessment reporting: ACTTION systematic review and recommendations.

UNLABELLED: Pain intensity assessments are used widely in human pain research, and their transparent reporting is crucial to interpreting study results. In this systematic review, we examined reporting of human pain intensity assessments and related elements (eg, administration frequency, time period assessed, type of pain) in all empirical pain studies with adult participants in 3 major pain journals (ie, European Journal of Pain, Journal of Pain, and Pain) between January 2011 and July 2012. Of the 262 articles identified, close to one-quarter (24%) ambiguously reported the pain intensity assessment. Elements related to the pain intensity assessment were frequently not reported: 31% did not identify the time period participants were asked to rate, 43% failed to report the type of pain intensity rated, and 58% did not report the specific location or pain condition rated. No differences were observed between randomized clinical trials and experimental (eg, studies involving experimental manipulation without random group assignment and blinding) and observational studies in reporting quality. The ability to understand study results, and to compare results between studies, is compromised when pain intensity assessments are not fully reported. Recommendations are presented regarding key details for investigators to consider when conducting and reporting pain intensity assessments in human adults. PERSPECTIVE: This systematic review demonstrates that publications of pain research often incompletely report pain intensity assessments and their details (eg, administration frequency, type of pain). Failure to fully report details of pain intensity assessments creates ambiguity in interpreting research results. Recommendations are proposed to increase transparent reporting.

Data interpretation in analgesic clinical trials with statistically nonsignificant primary analyses: an ACTTION systematic review.

UNLABELLED: Peer-reviewed publications of randomized clinical trials (RCTs) are the primary means of disseminating research findings. "Spin" in RCT publications is misrepresentation of statistically nonsignificant research findings to suggest treatment benefit. Spin can influence the way readers interpret clinical trials and use the information to make decisions about treatments and medical policies. The objective of this study was to determine the frequency with which 4 types of spin were used in publications of analgesic RCTs with nonsignificant primary analyses in 6 major pain journals. In the 76 articles included in our sample, 28% of the abstracts and 29% of the main texts emphasized secondary analyses with P values <.05; 22% of abstracts and 29% of texts emphasized treatment benefit based on nonsignificant primary results; 14% of abstracts and 18% of texts emphasized within-group improvements over time, rather than primary between-group comparisons; and 13% of abstracts and 10% of texts interpreted a nonsignificant difference between groups in a superiority study as comparable effectiveness. When considering the article conclusion sections, 21% did not mention the nonsignificant primary result, 22% were presented with no uncertainty or qualification, 30% did not acknowledge that future research was required, and 8% recommended the intervention for clinical use. PERSPECTIVE: This article identifies relatively frequent "spin" in analgesic RCTs. These findings highlight a need for authors, reviewers, and editors to be more cognizant of how analgesic RCT results are presented and attempt to minimize spin in future clinical trial publications.

Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review.

Assessment of treatment safety is 1 of the primary goals of clinical trials. Organizations and working groups have created reporting guidelines for adverse events (AEs). Previous research examining AE reporting for pharmacologic clinical trials of analgesics in major pain journals found many reporting inadequacies, suggesting that analgesic trials are not adhering to existing AE reporting guidelines. The present systematic review documented AE reporting in 3 main pain journals for nonpharmacologic, noninterventional (NP/NI) trials examining pain treatments. To broaden our pool of nonpharmacologic trials, we also included trials examining acupuncture, leech therapy, and noninvasive stimulation techniques (eg, transcutaneous electrical nerve stimulation). We documented AE reporting at 2 levels of specificity using coding manuals based on the Consolidated Standards of Reporting Trials (CONSORT) harms reporting standards and Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) AE reporting checklist. We identified a number of inadequacies in AE reporting across the 3 journals. For example, using the ACTTION coding manual, we found that less than one-half of the trials reported specific AE assessment methods; approximately one-third of the trials reported withdrawals due to AEs for each study arm; and about one-fourth of the trials reported all specific AEs. We also examined differences in AE reporting across several trial characteristics, finding that AE reporting was generally more detailed in trials with patients versus those using healthy volunteers undergoing experimentally evoked pain. These results suggest that investigators conducting and reporting NP/NI clinical trials are not adequately describing the assessment and occurrence of AEs.

Reporting of missing data and methods used to accommodate them in recent analgesic clinical trials: ACTTION systematic review and recommendations.

Missing data in clinical trials can bias estimates of treatment effects. Statisticians and government agencies recommend making every effort to minimize missing data. Although statistical methods are available to accommodate missing data, their validity depends on often untestable assumptions about why the data are missing. The objective of this study was to assess the frequency with which randomized clinical trials published in 3 major pain journals (ie, European Journal of Pain, Journal of Pain, and Pain) reported strategies to prevent missing data, the number of participants who completed the study (ie, completers), and statistical methods to accommodate missing data. A total of 161 randomized clinical trials investigating treatments for pain, published between 2006 and 2012, were included. Approximately two-thirds of the trials reported at least 1 method that could potentially minimize missing data, the most common being allowance of concomitant medications. Only 61% of the articles explicitly reported the number of patients who were randomized and completed the trial. Although only 14 articles reported that all randomized participants completed the study, fewer than 50% of the articles reported a statistical method to accommodate missing data. Last observation carried forward imputation was used most commonly (42%). Thirteen articles reported more than 1 method to accommodate missing data; however, the majority of methods, including last observation carried forward, were not methods currently recommended by statisticians. Authors, reviewers, and editors should prioritize proper reporting of missing data and appropriate use of methods to accommodate them so as to improve the deficiencies identified in this systematic review.

Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations.

Performing multiple analyses in clinical trials can inflate the probability of a type I error, or the chance of falsely concluding a significant effect of the treatment. Strategies to minimize type I error probability include prespecification of primary analyses and statistical adjustment for multiple comparisons, when applicable. The objective of this study was to assess the quality of primary analysis reporting and frequency of multiplicity adjustment in 3 major pain journals (ie, European Journal of Pain, Journal of Pain, and PAIN®). A total of 161 randomized controlled trials investigating noninvasive pharmacological treatments or interventional treatments for pain, published between 2006 and 2012, were included. Only 52% of trials identified a primary analysis, and only 10% of trials reported prespecification of that analysis. Among the 33 articles that identified a primary analysis with multiple testing, 15 (45%) adjusted for multiplicity; of those 15, only 2 (13%) reported prespecification of the adjustment methodology. Trials in clinical pain conditions and industry-sponsored trials identified a primary analysis more often than trials in experimental pain models and non-industry-sponsored trials, respectively. The results of this systematic review demonstrate deficiencies in the reporting and possibly the execution of primary analyses in published analgesic trials. These deficiencies can be rectified by changes in, or better enforcement of, journal policies pertaining to requirements for the reporting of analyses of clinical trial data.