Predictive Modeling for One-Year Lower Extremity Endovascular Revascularization Failure in Black Persons.

INTRODUCTION: Black persons bear a disproportionate burden of peripheral artery disease (PAD) and experience higher rates of endovascular revascularization failure (ERF) when compared with non-Hispanic White persons. We aimed to identify predictors of ERF in Black persons using predictive modeling. METHODS: This retrospective study included all persons identifying as Black who underwent an initial endovascular revascularization procedure for PAD between 2011 and 2018 at a midwestern tertiary care center. Three predictive models were developed using (1) logistic regression, (2) penalized logistic regression (least absolute shrinkage and selection operator [LASSO]), and (3) random forest (RF). Predictive performance was evaluated under repeated cross-validation. RESULTS: Of the 163 individuals included in the study, 113 (63.1%) experienced ERF at 1 y. Those with ERF had significant differences in symptom status (P < 0.001), lesion location (P < 0.001), diabetes status (P = 0.037), and annual procedural volume of the attending surgeon (P < 0.001). Logistic regression and LASSO models identified tissue loss, smoking, femoro-popliteal lesion location, and diabetes control as risk factors for ERF. The RF model identified annual procedural volume, age, PAD symptoms, number of comorbidities, and lesion location as most predictive variables. LASSO and RF models were more sensitive than logistic regression but less specific, although all three methods had an overall accuracy of ≥75%. CONCLUSIONS: Black persons undergoing endovascular revascularization for PAD are at high risk of ERF, necessitating need for targeted intervention. Predictive models may be clinically useful for identifying high-risk patients, although individual predictors of ERF varied by model. Further exploration into these models may improve limb salvage for this population.

The heterogeneous wound microbiome varies with wound care pain, dressing type, and inflammatory gene expression.

Wound dressing changes are essential procedures for wound management. However, ~50% of patients experience severe pain during these procedures despite the availability of analgesic medications, indicating a need for novel therapeutics that address underlying causes of pain. Along with other clinical factors, wound pathogens and inflammatory immune responses have previously been implicated in wound pain. To test whether these factors could contribute to severe pain during wound dressing changes, we conducted an exploratory, cross-sectional analysis of patient-reported pain, inflammatory immune responses, and wound microbiome composition in 445 wounds at the time of a study dressing change. We profiled the bacterial composition of 406 wounds using 16S ribosomal RNA amplicon sequencing and quantified gene expression of 13 inflammatory markers in wound fluid using quantitative real-time polymerase chain reaction (qPCR). Neither inflammatory gene expression nor clinically observed inflammation were associated with severe pain, but Corynebacterium and Streptococcus were of lower relative abundance in wounds of patients reporting severe pain than those reporting little or no pain. Wound microbiome composition differed by wound location, and correlated with six of the inflammatory markers, including complement receptor C5AR1, pro-inflammatory cytokine interleukin (IL)1ß, chemokine IL-8, matrix metalloproteinase MMP2, and the antimicrobial peptide encoding cathelicidin antimicrobial peptide. Interestingly, we found a relationship between the wound microbiome and vacuum-assisted wound closure (VAC). These findings identify preliminary, associative relationships between wound microbiota and host factors which motivate future investigation into the directional relationships between wound care pain, wound closure technologies, and the wound microbiome.

Genome-wide association studies with experimental validation identify a protective role for B lymphocytes against chronic post-surgical pain.

BACKGROUND: Chronic post-surgical pain (CPSP) significantly impacts patients' recovery and quality of life. Although environmental risk factors are well-established, genetic risk remains less understood. METHODS: A meta-analysis of genome-wide association studies followed by partitioned heritability was performed on 1350 individuals across five surgery types: hysterectomy, mastectomy, abdominal, hernia, and knee. In subsequent animal studies, withdrawal thresholds to evoked mechanical stimulation were measured in Rag1 null mutant and wild-type mice after plantar incision and laparotomy. Cell sorting by flow cytometry tracked recruitment of immune cell types. RESULTS: We discovered 77 genome-wide significant single-nucleotide polymorphism (SNP) hits, distributed among 24 loci and 244 genes. Meta-analysis of all cohorts estimated a SNP-based narrow-sense heritability for CPSP at ∼39%, indicating a substantial genetic contribution. Partitioned heritability analysis across a wide variety of tissues revealed enrichment of heritability in immune system-related genes, particularly those associated with B and T cells. Rag1 null mutant mice lacking both T and B cells exhibited exacerbated and prolonged allodynia up to 42 days after surgery, which was rescued by B-cell transfer. Recruitment patterns of B cells but not T cells differed significantly during the first 7 days after injury in the footpad, lymph nodes, and dorsal root ganglia. CONCLUSIONS: These findings suggest a key protective role for the adaptive immune system in the development of chronic post-surgical pain.

Agreement between patient-reported and clinically documented symptoms of acute myeloid leukemia: Study protocol.

AIM: To describe our methods to compare patient-reported symptoms of acute myeloid leukemia and the corresponding documentation by healthcare providers in the electronic health record. BACKGROUND: Patients with acute myeloid leukemia experience many distressing symptoms, particularly related to chemotherapy. The timely recognition and provision of evidence-based interventions to manage these symptoms can improve outcomes. However, lack of standardized formatting for symptom documentation within electronic health records leads to challenges for clinicians when accessing and comprehending patients' symptom information, as it primarily exists in narrative forms in various parts of the electronic health record. This variability raises concerns about over- or under-reporting of symptoms. Consistency between patient-reported symptoms and clinician's symptom documentation is important for patient-centered symptom management, but little is known about the degree of agreement between patient reports and their documentation. This is a detailed description of the study's methodology, procedures and design to determine how patient-reported symptoms are similar or different from symptoms documented in electronic health records by clinicians. DESIGN: Exploratory, descriptive study. METHODS: Forty symptoms will be assessed as patient-reported outcomes using the modified version of the Memorial Symptom Assessment Scale. The research team will annotate symptoms from the electronic health record (clinical notes and flowsheets) corresponding to the 40 symptoms. The degree of agreement between patient reports and electronic health record documentation will be analyzed using positive and negative agreement, kappa statistics and McNemar's test. CONCLUSION: We present innovative methods to comprehensively compare the symptoms reported by acute myeloid leukemia patients with all available electronic health record documentation, including clinical notes and flowsheets, providing insights into symptom reporting in clinical practice. IMPACT: Findings from this study will provide foundational understanding and compelling evidence, suggesting the need for more thorough efforts to assess patients' symptoms. Methods presented in this paper are applicable to other symptom-intensive diseases.

Evaluation of art making activity as a pain management strategy for older adults and their experience using an art making intervention.

Chronic pain is a common and bothersome experience for older adults. Consequently, pain management is critical to maintaining their function and well-being. Art making, a non-pharmacological approach, has gained empirical support and is used for functional and cognitive improvement in older adults. However, it has rarely been used to manage chronic pain. The purpose of this descriptive qualitative study was to understand older adults' experience using a newly designed art making intervention and its influence on their pain. Overall, 11 older adults used the intervention and reported its quality to be appropriate. Moreover, older adults reported that art making was an engaging, diversional activity which reduced their pain severity and improved their mood. The findings of this study will be used to inform a future pilot study to assess the impact of art making on pain management in older adults with chronic pain.

Translating Outcomes from the Clinical Setting to Preclinical Models: Chronic Pain and Functionality in Chronic Musculoskeletal Pain.

Fibromyalgia (FM) is a chronic pain disorder characterized by chronic widespread musculoskeletal pain (CWP), resting pain, movement-evoked pain (MEP), and other somatic symptoms that interfere with daily functioning and quality of life. In clinical studies, this symptomology is assessed, while preclinical models of CWP are limited to nociceptive assays. The aim of the study was to investigate the human-to-model translatability of clinical behavioral assessments for spontaneous (or resting) pain and MEP in a preclinical model of CWP. For preclinical measures, the acidic saline model of FM was used to induce widespread muscle pain in adult female mice. Two intramuscular injections of acidic or neutral pH saline were administered following baseline measures, 5 days apart. An array of adapted evoked and spontaneous pain measures and functional assays were assessed for 3 weeks. A novel paradigm for MEP assessment showed increased spontaneous pain following activity. For clinical measures, resting and movement-evoked pain and function were assessed in adult women with FM. Moreover, we assessed correlations between the preclinical model of CWP and in women with fibromyalgia to examine whether similar relationships between pain assays that comprise resting and MEP existed in both settings. For both preclinical and clinical outcomes, MEP was significantly associated with mechanical pain sensitivity. Preclinically, it is imperative to expand how the field assesses spontaneous pain and MEP when studying multi-symptom disorders like FM. Targeted pain assessments to match those performed clinically is an important aspect of improving preclinical to clinical translatability of animal models.

An integrated model of multimorbidity and symptom science.

BACKGROUND: Prevalence and complexity of persons with multiple chronic conditions (MCC), also known as multimorbidity, are shifting clinical practice from a single disease focus to one considering MCC and symptoms. Although symptoms are intricately bound to concepts inherent in MCC science, symptoms are largely ignored in multimorbidity research and literature. PURPOSE: Introduce an Integrated Model of Multimorbidity and Symptom Science. METHODS: Critical integrative review and synthesis process. FINDINGS: The model comprises three primary domains: 1. Contributing/ Risk Factors; 2. Symptom/Disease/Treatment Interactions; and 3. Patient Outcomes. DISCUSSION: The model highlights the multilevel nature of contributing factors and the recursive interactions among multiple etiologies, conditions, symptoms, therapies, and outcomes.

A single-session acceptance and commitment therapy intervention among women undergoing surgery for breast cancer: A randomized pilot trial to reduce persistent postsurgical pain.

OBJECTIVE: Oncologic breast surgeries carry a risk for persistent postsurgical pain. This study was a randomized pilot and feasibility study of a single-session Acceptance and Commitment Therapy (ACT) intervention compared with treatment as usual among women undergoing surgery for breast cancer or ductal carcinoma in situ. METHODS: Participants were recruited via letter of invitation and follow-up phone call from a single site in the United States from 2015 to 2017. Participants were at risk for persistent postsurgical pain, based on young age (<50), a preexisting chronic pain condition, or elevated anxiety, depression, or pain catastrophizing. RESULTS: The 54 participants were female with a mean age of 52.91 years (SD=11.80). At 3-month postsurgery, 11% of the sample reported moderate-severe pain (>3 on a 0-10 numeric rating scale) in the operative breast or with arm movement. Written qualitative responses indicated that the majority of participants who received the intervention understood the concepts presented and reported continued practice of exercises learned in the session. The between group effect sizes for moderate-severe pain and elevated anxiety at 3-month post-surgery were small (Phi=0.08 and 0.16, respectively). The between group effect sizes for depression, pain acceptance, and pain catastrophizing at 3-month postsurgery were minimal. CONCLUSIONS: This study found small positive effects on postsurgical pain and anxiety for a single-session ACT intervention among women with breast cancer. This study supports the use of ACT with this population.

Severe pain during wound care procedures: A cross-sectional study protocol.

AIM: The aim of this study is to: (a) develop and evaluate a model to predict severe pain during wound care procedures (WCPs) so that high-risk patients can be targeted for specialized dressings and preventive pain control; and (b) identify biological factors associated with severe pain during WCPs so that novel pain control strategies can be developed. BACKGROUND: Wound care procedures such as dressing changes can cause moderate to severe pain in 74% of patients, with nearly half (36%) of all patients experiencing severe pain (rated as 8-10 on a 10-point numeric rating scale) during dressing change. Additionally, clinicians have little direction with current guidelines regarding pain control during WCPs including the selection of the appropriate advanced wound dressings and the appropriate use of analgesics. DESIGN: This is a cross-sectional study. METHODS: The National Institute of Nursing Research approved and funded the study June of 2015 and the appropriate Institutional Review Board approved all study protocols prior to funding. Study enrolment is underway at the University of Iowa Hospitals and Clinics with a target of 525 participants. Potential participants must be adults (21+ years) and have a nonburn, nondiabetic foot, full-thickness wound. The research team performs a one-time study dressing change on enrolled participants and collects all study data. DISCUSSION: This study will allow the development of a tool for clinicians to use to predict severe pain during WCPs and identify biological factors significantly associated with severe pain during WCPs.

Factors associated with high pain intensity during wound care procedures: A model.

The most common wound care procedures (WPCs) performed on open wounds are dressing changes and wound cleansing. Dressing changes cause moderate to severe pain in 74% of patients, nearly half (36%) of whom experience severe pain (rated as 8-10 on a 10-point numeric rating scale). The purpose of this paper is to propose a model of clinically accessible factors that can be tested in order to develop a clinical tool to identify which patients are likely to experience high intensity pain during nonoperative WCPs, such as dressing changes. Although multiple factors are known to be associated with pain, the factors selected for this model were limited to those that (1) are supported based on evidence and/or pain mechanisms and (2) are readily accessible to clinicians/practitioners and can be tested as a prediction tool to be used prior to WCPs. This model may be helpful to identify those likely to experience high intensity pain during WCPs. In this way, use of aggressive pain management strategies, including specialty dressings, pharmacologic analgesics, and/or non-pharmacological strategies, such as high intensity transcutaneous electrical stimulation.

Reliability and Construct Validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments in Women with Fibromyalgia.

OBJECTIVE: The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to standardize measurement of clinically relevant patient-reported outcomes. This study evaluated the reliability and construct validity of select PROMIS static short-form (SF) instruments in women with fibromyalgia. DESIGN: Analysis of baseline data from the Fibromyalgia Activity Study with TENS (FAST), a randomized controlled trial of the efficacy of transcutaneous electrical nerve stimulation. SETTING: Dual site, university-based outpatient clinics. SUBJECTS: Women aged 20 to 67 years diagnosed with fibromyalgia. METHODS: Participants completed the Revised Fibromyalgia Impact Questionnaire (FIQR) and 10 PROMIS static SF instruments. Internal consistency was calculated using Cronbach alpha. Convergent validity was examined against the FIQR using Pearson correlation and multiple regression analysis. RESULTS: PROMIS static SF instruments had fair to high internal consistency (Cronbach α = 0.58 to 0.94, P < 0.05). PROMIS 'physical function' domain score was highly correlated with FIQR 'function' score (r = -0.73). The PROMIS 'total' score was highly correlated with the FIQR total score (r = -0.72). Correlations with FIQR total score of each of the three PROMIS domain scores were r = -0.65 for 'physical function,' r = -0.63 for 'global,' and r = -0.57 for 'symptom' domain. PROMIS 'physical function,' 'global,' and 'symptom' scores explained 58% of the FIQR total score variance. CONCLUSIONS: Select PROMIS static SF instruments demonstrate convergent validity with the FIQR, a legacy measure of fibromyalgia disease severity. These results highlight the potential utility of select PROMIS static SFs for assessment and tracking of patient-reported outcomes in fibromyalgia.

Relationships among pain intensity, pain-related distress, and psychological distress in pre-surgical total knee arthroplasty patients: a secondary analysis.

The current study aimed to examine the relationships between movement and resting pain intensity, pain-related distress, and psychological distress in participants scheduled for total knee arthroplasty (TKA). This study examined the impact of anxiety, depression, and pain catastrophizing on the relationship between pain intensity and pain-related distress. Data analyzed for the current study (N = 346) were collected at baseline as part of a larger Randomized Controlled Trial investigating the efficacy of TENS for TKA (TANK Study). Participants provided demographic information, pain intensity and pain-related distress, and completed validated measures of depression, anxiety, and pain catastrophizing. Only 58% of the sample reported resting pain >0 while 92% of the sample reported movement pain >0. Both movement and resting pain intensity correlated significantly with distress (rs = .86, p < .01 and .79, p < .01, respectively). About three quarters to two thirds of the sample (78% for resting pain and 65% for movement pain) reported different pain intensity and pain-related distress. Both pain intensity and pain-related distress demonstrated significant relationships with anxiety, depression, and catastrophizing. Of participants reporting pain, those reporting higher anxiety reported higher levels of distress compared to pain intensity. These findings suggest that anxious patients may be particularly distressed by movement pain preceding TKA. Future research is needed to investigate the utility of brief psychological interventions for pre-surgical TKA patients.

Iowa Model of Evidence-Based Practice: Revisions and Validation.

BACKGROUND: The Iowa Model is a widely used framework for the implementation of evidence-based practice (EBP). Changes in health care (e.g., emergence of implementation science, emphasis on patient engagement) prompted the re-evaluation, revision, and validation of the model. METHODS: A systematic multi-step process was used capturing information from the literature and user feedback via an electronic survey and live work groups. The Iowa Model Collaborative critically assessed and synthesized information and recommendations before revising the model. RESULTS: Survey participants (n = 431) had requested access to the Model between years 2001 and 2013. Eighty-eight percent (n = 379) of participants reported using the Iowa Model and identified the most problematic steps as: topic priority, critique, pilot, and institute change. Users provided 587 comments with rich contextual rationale and insightful suggestions. The revised model was then evaluated by participants (n = 299) of the 22nd National EBP Conference in 2015. They validated the model as a practical tool for the EBP process across diverse settings. Specific changes in the model are discussed. CONCLUSION: This user driven revision differs from other frameworks in that it links practice changes within the system. Major model changes are expansion of piloting, implementation, patient engagement, and sustaining change. LINKING EVIDENCE TO ACTION: The Iowa Model-Revised remains an application-oriented guide for the EBP process. Intended users are point of care clinicians who ask questions and seek a systematic, EBP approach to promote excellence in health care.

Preoperative predictors of pain following total knee arthroplasty.

Total knee arthroplasty has provided dramatic improvements in function and pain for the majority of patients with knee arthritis, yet a significant proportion of patients remain dissatisfied with their results. We performed a prospective analysis of 215 patients undergoing TKA who underwent a comprehensive array of evaluations to discover whether any preoperative assessment could predict high pain scores and functional limitations postoperatively. Patients with severe pain with a simple knee range-of-motion test prior to TKA had a 10 times higher likelihood of moderate to severe pain at 6 months. A simple test of pain intensity with active flexion and extension preoperatively was a significant predictor of postoperative pain at 6 months after surgery. Strategies to address this particular patient group may improve satisfaction rates of TKA.

Influence of Transcutaneous Electrical Nerve Stimulation (TENS) on Pressure Pain Thresholds and Conditioned Pain Modulation in a Randomized Controlled Trial in Women With Fibromyalgia.

Transcutaneous electrical nerve stimulation (TENS) effectively reduces pain in fibromyalgia (FM). The purpose of this study was to examine the influence of TENS use on pressure pain thresholds (PPT) and conditioned pain modulation (CPM) in individuals with FM using data from the Fibromyalgia Activity Study with TENS trial (NCT01888640). Individuals with FM were randomly assigned to receive active TENS, placebo TENS, or no TENS for 4 weeks. A total of 238 females satisfied the per-protocol analysis among the active TENS (n = 76), placebo TENS (n = 68), and no TENS (n = 94) groups. Following 4 weeks of group allocation, the active TENS group continued for an additional 4 weeks of active TENS totaling 8 weeks (n = 66), the placebo and no TENS groups transitioned to receive 4 weeks of active TENS (delayed TENS, n = 161). Assessment of resting pain, movement-evoked pain (MEP), PPT, and CPM occurred prior to and following active, placebo, or no TENS. There were no significant changes in PPT or CPM among the active TENS, placebo TENS, or no TENS groups after 4 weeks. Individuals who reported clinically relevant improvements in MEP (≥30% decrease) demonstrated increases in PPT (P < .001), but not CPM, when compared to MEP non-responders. There were no significant correlations among the change in PPT or CPM compared to MEP and resting pain following active TENS use (active TENS + delayed TENS). PPT and CPM may provide insight to underlying mechanisms contributing to pain; however, these measures may not relate to self-reported pain symptoms. PERSPECTIVE: Pressure pain threshold increased in individuals with clinically relevant improvement (≥30%) in MEP, indicating the clinical relevance of PPT for understanding mechanisms contributing to pain. CPM was not a reliable indicator of treatment response in MEP responders.

Demystifying the virtualization process: A call for standard reporting of virtual modifications to evidence-based psychotherapies, using the FRAME model.

The sudden onset of the coronavirus disease led to a rapid expansion of video telehealth to deliver mental healthcare. Although video telehealth was not a new clinical practice, there was limited guidance on how best to modify evidence-based psychotherapies (EBPs) for virtual delivery (a process also referred to as virtualization). The virtualization process for EBPs remains unclear as newly emerging reports on this topic do not consistently report modification decisions. This commentary calls attention to the need to improve documentation practices to allow a greater understanding of modifications needed to maximize the positive effects of EBPs transported to a virtual format. We used the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) to capture details about the nature, process, and outcomes of intervention modifications across a given clinical setting or population. To illustrate the use of the FRAME, we present a case example describing our experiences with transporting a 1-day in-person Acceptance and Commitment Therapy group workshop to a virtual format. Workshop modifications primarily involved changes to the delivery format, administration procedures, and content. The case example walks through how, why, and by whom specific modifications were made as well as the degree to which fidelity was maintained. In the wake of the telemedicine revolution, further investigation into the virtualization process for EBPs is warranted. Improving reporting practices by using the FRAME or a similar adaptation framework will promote a more rigorous study of virtual modifications to EBPs that inform future guidelines and best practices.

Video telehealth rapidly expanded during COVID-19 as a preferred method for delivering mental health treatment. The sudden, unexpected onset of the pandemic left healthcare systems and individual clinicians little time to shift their services to this virtual format. In addition, there was and remains limited information on the most effective ways to modify evidence-based psychotherapies for virtual delivery (a process known as virtualization). To fill this knowledge gap, this commentary calls for improved documentation and evaluation of the virtualization process. We provide a case example demonstrating how to use the Framework for Reporting Adaptations and Modifications-Expanded­a comprehensive system to detail the nature and process of treatment modifications within a given context. Routine use of this or similar adaptation models within the field of behavioral and social sciences will provide a better understanding of changes needed to ensure the continuity and integrity of evidence-based psychotherapies modified for video telehealth delivery.

Genome-wide association study suggests a critical contribution of the adaptive immune system to chronic post-surgical pain.

Chronic post-surgical pain affects a large proportion of people undergoing surgery, delaying recovery time and worsening quality of life. Although many environmental variables have been established as risk factors, less is known about genetic risk. To uncover genetic risk factors we performed genome-wide association studies in post-surgical cohorts of five surgery types- hysterectomy, mastectomy, abdominal, hernia, and knee- totaling 1350 individuals. Genetic associations between post-surgical chronic pain levels on a numeric rating scale (NRS) and additive genetic effects at common SNPs were evaluated. We observed genome-wide significant hits in almost all cohorts that displayed significance at the SNP, gene, and pathway levels. The cohorts were then combined via a GWAS meta-analysis framework for further analyses. Using partitioned heritability, we found that loci at genes specifically expressed in the immune system carried enriched heritability, especially genes related to B and T cells. The relevance of B cells in particular was then demonstrated in mouse postoperative pain assays. Taken altogether, our results suggest a role for the adaptive immune system in chronic post-surgical pain.

Item Response Theory Analysis: PROMIS® Anxiety Form and Generalized Anxiety Disorder Scale.

Little research has compared item functioning of the Patient-Reported Outcomes Measurement Information System (PROMIS®) anxiety short form 6a and the generalized anxiety disorder 7-item scale using item response theory models. This was a secondary analysis of self-reported assessments from 67 at-risk U.S. military veterans. The two measures performed comparably well with data fitting adequately to models, acceptable item discriminations, and item and test information curves being unimodal and symmetric. The PROMIS® anxiety short form 6a performed better in that item difficulty estimates had a wider range and distributed more evenly and all response categories had less floor effect, while the third category in most items of the generalized anxiety disorder 7-item scale were rarely used. While both measures may be appropriate, findings provided preliminary information supporting use of the PROMIS® anxiety short form 6a as potentially preferable, especially for veterans with low-to-moderate anxiety. Further testing is needed in larger, more diverse samples.

The Influence of Opioids on Transcutaneous Electrical Nerve Stimulation Effects in Women With Fibromyalgia.

Transcutaneous electrical nerve stimulation (TENS) uses endogenous opioids to produce analgesia, and effectiveness can be reduced in opioid-tolerant individuals'. We examined TENS effectiveness (primary aim), and differences in fibromyalgia symptoms (secondary aim), in women with fibromyalgia regularly taking opioid (RTO) medications compared with women not- regularly taking opioids (not-RTO). Women (RTO n = 79; not-RTO not-n = 222) with fibromyalgia with daily pain levels ≥4 were enrolled and categorized into RTO (taking opioids at least 5 of 7 days in last 30 days) or not-RTO groups. Participants were categorized into tramadol n = 52 (65.8%) and other opioids n = 27 (34.2%) for the RTO group. Participants were phenotyped across multiple domains including demographics, fibromyalgia characteristics pain, fatigue, sleep, psychosocial factors, and activity. Participants were randomized to active TENS (n = 101), placebo TENS (n = 99), or no TENS (n = 99) for 1-month with randomization stratified by opioid use. Active TENS was equally effective in movement-evoked pain in those in the RTO and not-RTO groups. Women with fibromyalgia in the RTO group were older (P = .002), lower-income (P = .035), more likely to smoke (P = .014), and more likely to report depression (P = .013), hypertension (P = .005) or osteoarthritis (P = .027). The RTO group demonstrated greater bodily pain on SF-36 (P = .005), lower quality of life on the physical health component of the SF-36 (P = .040), and greater fatigue (MAF-ADL P = .047; fatigue with sit to stand test (P = .047) These differences were small of and unclear clinical significance. In summary, regular use of opioid analgesics does not interfere with the effectiveness of TENS for movement-evoked pain. Clinical Trial Registration Number: NCT01888640. PERSPECTIVE: Individuals treated with mixed frequency TENS at a strong but comfortable intensity that was taking prescription opioid analgesics showed a significant reduction in movement-evoked pain and fatigue. These data support the use of TENS, using appropriate parameters of stimulation, as an intervention for individuals with fibromyalgia taking opioid analgesics.

A clinical tool to predict severe pain during wound dressing changes.

ABSTRACT: Dressing changes cause severe pain (ie, 8-10 on a 10-point scale) for approximately one-third (36%) of patients with open skin wounds. No tool exists that allows nurses to predict which patients are likely to experience severe pain during dressing changes. The aim of this study was to develop a clinical tool to predict severe pain during dressing changes using clinically accessible wound and pain predictors and to evaluate the diagnostic validity of this model. Using a cross-sectional design, a one-time study dressing change was conducted by the same wound care nurse on 445 subjects while concurrently measuring patient and wound predictors and pain intensity during the dressing change. Three predictors came out of the study as most useful for a clinical prediction tool: type of dressing, resting wound pain, and expected pain. Algorithms based on these predictors are presented, which can be applied in other settings to predict patients likely to experience severe pain during a dressing change. This is the first study to systematically examine a comprehensive set of wound and patient predictors for their individual and collective associations with pain during dressing changes using precisely defined and rigorously measured study variables. The ability to predict which patients are likely to have severe pain during dressing changes is critically needed so that they can be targeted for preventive pain control strategies.