Shannon M. Smith's research while affiliated with University of Rochester Medical Center and other places

Publications (50)

Article
Chronic pelvic pain (CPP) in women is characterized by complex etiologies, psychosocial comorbidities, and treatment difficulties. Dysmenorrhea and the associated psychosocial and functional impairment beginning in adolescence may facilitate the transition into more debilitating CPP. This study describes dysmenorrhea history in a clinical sample of...
Article
Randomized clinical trials have demonstrated the efficacy of opioid analgesics for the treatment of acute and chronic pain conditions, and for some patients, these medications may be the only effective treatment available. Unfortunately, opioid analgesics are also associated with major risks (e.g., opioid use disorder) and adverse outcomes (e.g., r...
Article
There is tremendous interpatient variability in the response to analgesic therapy (even for efficacious treatments), which can be the source of great frustration in clinical practice. This has led to calls for “precision medicine” or personalized pain therapeutics (ie, empirically based algorithms that determine the optimal treatments, or treatment...
Article
Full-text available
Clinical outcome assessments (COAs) measure outcomes that are meaningful to patients in clinical trials and are critical for determining whether a treatment is effective. The objectives of this study are to (1) describe the different types of COAs and provide an overview of key considerations for evaluating COAs, (2) review COAs and other outcome m...
Article
Objective: Identifying biomarkers is a priority in translational chronic pain research. Dehydroepiandrosterone (DHEA) and its sulfated form, DHEA-S, are adrenocortical steroids in the blood with neuroprotective properties that also produce sex hormones. They may capture key sex-specific neuroendocrine mechanisms of chronic pain. Design: Cross-sect...
Article
Interpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the use of analgesic treatments in clinical practice. In this article, we report on an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Tra...
Article
OBJECTIVE To synthesize the epidemiological findings for the associations between dysmenorrhea, including primary dysmenorrhea and endometriosis-associated dysmenorrhea, and any chronic pain conditions, including chronic pelvic pain, and chronic non-pelvic pain. DATA SOURCES PubMed, Embase, and CINAHL from inception to December 2019. STUDY ELIGIB...
Article
Objective: Current treatments for chronic pain have limited effectiveness and tolerability. With growing interest in the potential of cannabinoids, there is a need to inform risk-benefit considerations. Thus, this focused systematic review assesses the quality of safety assessment and reporting in chronic noncancer pain cannabinoid trials. Method...
Article
Introduction: The subjective experience of drug craving is a prominent and common clinical phenomenon for many individuals diagnosed with opioid use disorder (OUD), and could be a valuable clinical endpoint in medication development studies. The purpose of this scoping review is to provide an overview and critical analysis of opioid craving assess...
Article
Recent research has suggested that the magnitudes of analgesic treatment effects estimated in clinical trials have decreased over time. Implications of these findings for future sample size calculations and clinical trial research designs have not been addressed. In this article, we examine the standardized effect size (SES) for average pain intens...
Article
Objective: Couple interventions for chronic pain have been shown to more effectively reduce pain intensity for individuals with chronic pain (ICPs) than individual behavioral interventions or usual care. This systematic review identifies randomized controlled trials (RCTs) of couple interventions to highlight strategies that could be incorporated...
Article
Distal symmetrical axonal polyneuropathy (DSP) is due to injury to peripheral sensory, motor, and autonomic nerve fibers, resulting in distal predominant sensory loss, pain, and gait instability. DSP occurs as a complication of multiple medical conditions including diabetes or HIV, or following exposure to various toxins such as chemotherapy. It af...
Article
Fewer randomized clinical trials (RCTs) are conducted for chronic or recurrent pain in pediatric populations compared with adult populations; thus, data to support treatment efficacy in children are limited. This article evaluates the design features and reporting practices of RCTs for chronic and recurrent pain that are likely unique to, or partic...
Preprint
BACKGROUND Chronic pain affects a significant proportion of the population and presents a major challenge to clinicians and pain specialists. Despite availability of pharmacologic treatment options such as opioids, chronic pain persists in patients, perhaps because of a lack of analgesic efficacy or poor tolerability due to adverse effects. Cannabi...
Article
Integrating information on physical function and pain intensity into a composite measure may provide a useful method for assessing treatment efficacy in clinical trials of chronic pain. Accordingly, we evaluated composite outcomes in trials of duloxetine, gabapentin, and pregabalin. Data on 2,287 patients in 9 trials for painful diabetic peripheral...
Article
Identifying methods to improve assay sensitivity in randomized clinical trials (RCTs) may facilitate the discovery of efficacious pain treatments. RCTs evaluating pain treatments typically use average pain intensity (API) or worst pain intensity (WPI) as the primary efficacy outcome. However, little evidence is available comparing the assay sensiti...
Article
Chronic pain conditions occurring in the lower abdomen and pelvis are common, often challenging to manage, and can negatively affect health-related quality of life. Methodological challenges in designing randomized clinical trials (RCTs) for these conditions likely contributes to the limited number of available treatments. The goal of this systemat...
Article
Full-text available
Accurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) occurring in clinical trials is an important component in evaluating a medication's abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology a...
Article
Valid and reliable biomarkers can play an important role in clinical trials as indicators of biological or pathogenic processes or as a signal of treatment response. Currently, there are no biomarkers for pain qualified by the U.S. Food and Drug Administration or the European Medicines Agency for use in clinical trials. This article summarizes an I...
Article
Background and objectives: The objective of this study was to assess the reporting of randomized clinical trials investigating procedural treatments (eg, nerve blocks, targeted drug delivery) for cancer pain, with a focus on aspects that are particularly challenging in these trials. Methods: This article presents results from a systematic review...
Article
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 treatmen...
Article
Full-text available
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 clin...
Article
Cross-over trials are typically more efficient than parallel group trials in that the sample size required to yield a desired power is substantially smaller. It is important, however, to consider some issues specific to cross-over trials when designing and reporting them, and when evaluating the published results of such trials. This systematic rev...
Article
Introduction: No treatments for axonal peripheral neuropathy are approved by the FDA. Although patient- and clinician-reported outcomes are central to evaluating neuropathy symptoms, they can be difficult to assess accurately. The inability to identify efficacious treatments for peripheral neuropathies could be due to invalid or inadequate outcome...
Article
Full-text available
There is tremendous inter-patient variability in the response to analgesic therapy (even for efficacious treatments), which can be the source of great frustration in clinical practice. This has led to calls for "precision medicine", or personalized pain therapeutics (i.e., empirically-based algorithms that determine the optimal treatments, or treat...
Article
Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, M...
Article
Full-text available
Clinical trial participants often require additional instruction to prevent idiosyncratic interpretations regarding completion of patient-reported outcomes (PROs). The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership developed a training system with speci...
Article
Statistical methods and adverse events (that is, harms) data affect the accuracy of conclusions about the risk-to-benefit ratio of treatments for temporomandibular disorders (TMDs). The authors reviewed the quality of reporting in TMD clinical trials to highlight practices that are in need of improvement. The authors included articles published bet...
Article
Unlabelled: Measurement of inappropriate medication use events (eg, abuse or misuse) in clinical trials is important in characterizing a medication's abuse potential. However, no gold standard assessment of inappropriate use events in clinical trials has been identified. In this systematic review, we examine the measurement properties (ie, content...
Article
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 s...
Article
Sample size calculations are used to determine the number of participants required to have sufficiently high power to detect a given treatment effect. In this review, we examined the reporting quality of sample size calculations in 172 publications of double-blind RCTs of non-invasive pharmacologic or interventional (i.e., invasive) pain treatments...
Article
Peer-reviewed publications of randomized clinical trials (RCTs) are the primary means of disseminating research findings. “Spin” in RCT publications is misrepresentation of statistically non-significant research findings to suggest treatment benefit. Spin can influence the way readers interpret clinical trials and use the information to make decisi...
Article
The Intention-to-treat (ITT) principle states that all subjects in a randomized clinical trial (RCT) should be analyzed in the group to which they were assigned regardless of compliance with assigned treatment. Analyses performed according to the ITT principle preserve the benefits of randomization and are recommended by regulators and statistician...
Article
Assessment of treatment safety is one 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 trial...
Article
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 st...
Article
Eliminating publication bias requires ensuring public awareness of studies and access to results. clinical trial registries provide basic trial information, but access to unbiased trial results is inadequate. nearly all studies of trial registration and results reporting have been limited to the clinicaltrials.gov registry. we analyzed trial regist...
Article
Current approaches to classification of chronic pain conditions suffer from the absence of a systematically implemented and evidence-based taxonomy. Moreover, existing diagnostic approaches typically fail to incorporate available knowledge regarding the biopsychosocial mechanisms contributing to pain conditions. To address these gaps, the Analgesic...
Article
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 pre-specification of primary analyses and statistical adjustment for multiple comparisons, when applicable. The objective of...
Article
Assessing and mitigating the abuse liability (AL) of analgesics is an urgent clinical and societal problem. Analgesics have traditionally been assessed in randomized clinical trials (RCTs) designed to demonstrate analgesic efficacy relative to placebo or an active comparator. In these trials, rigorous, prospectively designed assessment for AL is ge...
Article
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 (POSs; i.e., definitions, timing, and analytic plans) in analgesic treatment trials correspond with published POSs. T...
Article
Full-text available
As the non-therapeutic use of prescription medications escalates, serious associated consequences have also increased, making it essential to estimate misuse, abuse, and related events (MAREs) in the development and post-marketing adverse event surveillance and monitoring of prescription drugs accurately. However, classifications and definitions to...
Article
Full-text available
The development of valid and informative treatment risk-benefit profiles requires consistent and thorough information about adverse event (AE) assessment and participants' AEs during randomized controlled trials (RCTs). Despite a 2004 extension of the Consolidated Standards of Reporting Trials (CONSORT) statement recommending the specific AE inform...
Article
Recommendations for harms (ie, adverse events) reporting in randomized clinical trial publications were presented in a 2004 extension of the Consolidated Standards of Reporting Trials (CONSORT) statement. Our objectives were to assess harms reporting in 3 major pain journals (European Journal of Pain, Journal of Pain, and PAIN®) to determine whethe...
Article
Discussing good news builds strength in relationships. In particular, perceiving a close other as enthusiastic about good fortune can help individuals maintain relational strength when relationship security is threatened. In an experiment and a daily diary study, how self‐esteem moderates perceptions of a partner's response to these capitalization...
Article
Full-text available
Sharing good news with others is one way that people can savor those experiences while building personal and interpersonal resources. Although prior research has established the benefits of this process, called capitalization, there has been little research and no experiments to examine the underlying mechanisms. In this article, we report results...

Citations

... Second, due to the lack of treatment cost data in the trial, we were unable to analyze the cost-effectiveness of our acetaminophen regime. Third, several outcomes that are helpful to comprehensively evaluate the opioid-sparing effects of a postoperative medication were left untouched in our trial, such as sleep quality, occurrence of deep vein thrombosis, and decreased peak respiratory flow (Gewandter et al., 2021)., Fourth, the variety range of the patients enrolled in our trial was relatively narrow. We only conducted the study in adults who underwent orthopedic surgery under general anesthesia. ...
... To assess overall change in health, participants were asked to complete the single-item Patient Global Impression of Change (PGIC) rating ("Since the start of the study, my overall status is…"). The PGIC has seven ordinal response options ranging from "very much worse" to "very much improved" (31,32). Participants completed all questionnaires online via REDCap. ...
... A stronger study design to test for efficacy would include an active control condition, such as an active placebo that mimics some of the acute effects of a psychedelic. Including both an active and inactive control condition (i.e., 3-arm design) is a promising way to disentangle placebo effects (Fillingim and Price 2005;Smith et al. 2020; Vase and WartolowVaseska 2019), because 3-arm trial designs allow for comparisons between both the treatment and the active placebo conditions with the inactive control condition to delineate treatment-specific effects from placebo effects (see Fig. 1a). There are also alternative study designs that may be especially useful because of psychedelic trials' vulnerability to large placebo effects. ...
... 42 Significantly, more women in the moderate-severe PP bothersomeness group (46%) reported pain present not during the menstrual cycle. More detailed characterisation of PP would be useful, but it would appear for women with more severe presentations of either cyclical or non-cyclical PP, 43 the consideration of pain sensitivity as a contributing factor is necessary. The richness of the data in the Raine Study allowed the profiling of participants across multiple biopsychosocial factors. ...
... When assessing the specific adverse effects experienced by trial participants, there were numerous effects that could adversely impact quality of life and adherence to treatment. Across all intervention subtypes, the most frequent adverse effects included dizziness, headache, fatigue, drowsiness, nausea, dry mouth, muscular weakness, headache and euphoria [281]. The frequency of serious adverse effects was 19.1% in studies of dronabinol, 4.4% in studies of oral THC:CBD capsules, 3.3% in studies of Nabiximols and 0% in studies of smoked THC and nabilone. ...
... The total score was summed at each assessment with higher scores indicating more craving. In the absence of a commonly accepted craving measurement for OUD ( Kleykamp et al., 2019 ), we chose a scale with evidence of face and discriminant validity that was found to have internal reliability ( r = .89) and was sensitive to change over time in populations with OUD ( Lydon-Staley et al., 2017 ). ...
... The statistically significant between-group differences for pain intensity (VAS) and disability (ODI) with standardized response means of 0.30 and 0.36, respectively, are modest treatment effect sizes consistent with those for existing efficacious treatments for chronic pain. 76,78 Improvements from baseline, which continued to accrue in all outcome measures after conclusion of the double-blind phase, were clinically important at 1 year, and the incidence of serious procedure-or device-related adverse events compared favorably with the literature for other neuromodulation therapies for chronic pain. ...
... and lower pain (d ϭ 0.19, p Ͻ .01)] (Martire, Schulz, Helgeson, Small, & Saghafi, 2010;Smith et al., 2019). These effect sizes emerged despite considerable variation in the content of the interventions (e.g., partner education, relaxation techniques). ...
... The classification of pain directly contributes to clinical treatment: nonsteroidal anti-inflammatory medicine is prescribed for nociceptive pain and voltage-dependant calcium channel blockers are administered for neuropathic pain. HIV infection and treatment, as well as amyloidosis, induce HIVassociated distal sensory polyneuropathy (HIV-DSP) owing to central or peripheral nervous system injury caused by direct viral infection, infection with secondary pathogens, or medication adverse effects; HIV-DSP is a painful condition that is difficult to treat and affects 29% to 62% of patients with HIV and acquired immunodeficiency syndrome (AIDS) [8]. HIV-DSP belongs to the category of neuropathic pain and is treated with voltage-dependant calcium channel blockers. ...
... 2,15 However, there are concerns about the uptake of these recommendations over the past 12 years. Connolly et al. 6 conducted a systematic review of reporting practices in 107 randomized controlled trials (RCTs) of pediatric chronic pain interventions. Nearly all trials included pain intensity as an outcome domain, but fewer than 35% included outcomes in any other recommended domain, suggesting insufficient use of this core outcome set (COS). ...