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Ruby HN Nguyen,1 Christin Veasley,2 Derek Smolenski1,3 1Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, 2National Vulvodynia Association, Silver Spring, MD, 3National Center for Telehealth and Technology, Defense Centers of Excellence, Department of Defense, Tacoma, WA, USA Background: The pattern and extent of clustering of comorbid pain conditions with vulvodynia is largely unknown. However, elucidating such patterns may improve our understanding of the underlying mechanisms involved in these common causes of chronic pain. We sought to describe the pattern of comorbid pain clustering in a population-based sample of women with diagnosed vulvodynia. Methods: A total of 1457 women with diagnosed vulvodynia self-reported their type of vulvar pain as localized, generalized, or both. Respondents were also surveyed about the presence of comorbid pain conditions, including temporomandibular joint and muscle disorders, interstitial cystitis, fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, endometriosis, and chronic headache. Age-adjusted latent class analysis modeled extant patterns of comorbidity by vulvar pain type, and a multigroup model was used to test for the equality of comorbidity patterns using a comparison of prevalence. A two-class model (no/single comorbidity versus multiple comorbidities) had the best fit in individual and multigroup models. Results: For the no/single comorbidity class, the posterior probability prevalence of item endorsement ranged from 0.9% to 24.4%, indicating a low probability of presence. Conversely, the multiple comorbidity class showed that at least two comorbid conditions were likely to be endorsed by at least 50% of women in that class, and irritable bowel syndrome and fibromyalgia were the most common comorbidities regardless of type of vulvar pain. Prevalence of the multiple comorbidity class differed by type of vulvar pain: both (37.6% prevalence, referent), generalized (21.6% prevalence, adjusted odds ratio 0.41, 95% confidence interval 0.27–0.61), or localized (12.5% prevalence, adjusted odds ratio 0.31, 95% confidence interval 0.21–0.47). Conclusion: This novel work provides insight into potential shared mechanisms of vulvodynia by describing that a prominent comorbidity pattern involves having both irritable bowel syndrome and fibromyalgia. In addition, the prevalence of a multiple comorbidity class pattern increases with increasing severity of vulvar pain. Keywords: vulvodynia, generalized, localized, comorbidity

Abstract Objective: To explore the economic burden and quality of life of vulvodynia in the United States. Methods: We conducted a web-based survey from 2009 to 2010. Patients who responded to a National Vulvodynia Association advertisement completed the survey every month, recording their own costs and their employers' payments related to vulvodynia in the previous month. A total of 302 patients entered data for at least 1 month and among them, 97 patients had completed data for 6 months. We used multiple imputation to generate values for unobserved cost components. For insurance payments, we also extracted the average insurance payments for direct healthcare services relating to vulvodynia from a commercial insurance database. The total costs were disaggregated into direct healthcare costs, direct non-healthcare costs and indirect costs. We also assessed patients' quality of life by using Euro QOL 5 dimensions (EQ-5D) in a follow-up survey. Results: The total costs in 6 months were $8862.40 per patient, of which $6043.34 (68.19%) were direct healthcare costs, $553.81 (6.25%) were direct non-healthcare costs and $2265.25 (25.56%) were indirect costs. Based on the reported prevalence range of 3-7% in the US, our analysis yielded an annual national burden ranging from $31 to $72 billion in the US. However, the estimate should be viewed with caution as our study sample was non-probability. The average EQ-5D score was 0.74 ± 0.19 in vulvodynia patients. Conclusion: Vulvodynia is associated with a huge economic burden to both individuals and society. It is also related to a relatively low quality of life. [ABSTRACT FROM AUTHOR]

Abstract: Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required. Trials aligned with routine practice pose several challenges, such as determining and enrolling appropriate study participants, deciding on the appropriate level of flexibility in treatment delivery, integrating information on concomitant treatments and adherence, and choosing comparator conditions and outcome measures. Ensuring data quality in real-world clinical settings is another challenging goal. Furthermore, current trials in the field would benefit from analysis methods that allow for a differentiated understanding of effects across patient subgroups and improved reporting of methods and context, which is required to assess the generalizability of findings. At the same time, a range of novel methodological approaches provide opportunities for enhanced efficiency and relevance of pragmatic trials to stakeholders and clinical decision making. In this study, best-practice considerations for these and other concerns in pragmatic trials of pain treatments are offered and a number of promising solutions discussed. The basis of these recommendations was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)

Abstract: In the traditional clinical research model, patients are typically involved only as participants. However, there has been a shift in recent years highlighting the value and contributions that patients bring as members of the research team, across the clinical research lifecycle. It is becoming increasingly evident that to develop research that is both meaningful to people who have the targeted condition and is feasible, there are important benefits of involving patients in the planning, conduct, and dissemination of research from its earliest stages. In fact, research funders and regulatory agencies are now explicitly encouraging, and sometimes requiring, that patients are engaged as partners in research. Although this approach has become commonplace in some fields of clinical research, it remains the exception in clinical pain research. As such, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials convened a meeting with patient partners and international representatives from academia, patient advocacy groups, government regulatory agencies, research funding organizations, academic journals, and the biopharmaceutical industry to develop consensus recommendations for advancing patient engagement in all stages of clinical pain research in an effective and purposeful manner. This article summarizes the results of this meeting and offers considerations for meaningful and authentic engagement of patient partners in clinical pain research, including recommendations for representation, timing, continuous engagement, measurement, reporting, and research dissemination., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)

Ten Chronic Overlapping Pain Conditions (COPCs) are currently recognized by the National Institutes of Health Pain Consortium (eg, irritable bowel syndrome, chronic migraine headache, and chronic low back pain). These conditions affect millions of Americans; however, assessing these conditions, their co-occurrence, and their relationship to treatment has proven challenging due to time constraints and a lack of standardized measures. We present a Chronic Overlapping Pain Condition-Screener (COPC-S) that is logic-driven, efficient, and freely available in electronic format to nonprofit entities. Thirty experts were convened to identify and modify self-report criteria for each COPC as well as criteria that trigger the administration of the diagnostic criteria from a body map and a brief series of questions. Their recommendations were then programmed into the Research Electronic Data Capture platform and refined for comprehensibility and ease of use by patient focus groups. The electronic screener and physician-administered criteria were both administered to patients with known COPCs in a counter-balanced fashion to determine the level of agreement between methods. The expert panel identified screening items/body map regions and diagnostic criteria for all 10 COPCs. Patients found the content comprehensible and the platform easy to use. Cohen's Kappa statistics suggested good agreement between the electronic COPC-S and criteria administered by a physician (κ = .813). The COPC-S is an efficient tool for screening multiple COPCs and has applicability to research studies, clinical trials, and clinical practice. PERSPECTIVE: Assessing COPCs remains a challenge for researchers and clinicians. The COPC-S is an efficient and logic-driven electronic tool that allows for the rapid screening assessment of 10 COPCs. The instrument may have utility in research and clinical settings., (Copyright © 2023. Published by Elsevier Inc.)

Optimizing health care decisions relies critically on the availability of health-related information appropriate to the specific needs and circumstances of the individual. Abundant research has demonstrated that information relevant to health care decision-making reflects disparities along multiple axes of sex, race, socioeconomic status, geography, sexual orientation, and other factors. Compounding the problem is that mechanisms of access to information themselves, increasingly recognized as part of the social determinants of health, can perpetuate and even exacerbate these disparities. Critical to achieving neurologic health equity is the application of evidence-based strategies to inform the effective and efficient communication of information that can influence patients' behaviors, enhance community trust in the scientific enterprise, and shape health systems and policies. In 2020, as part of a strategic planning initiative, the National Institute of Neurological Disorders and Stroke (NINDS) charged its Advisory Council to form a working group of experts to provide recommendations for reducing health disparities. Here, we report our subgroup's findings, which focused on the role of communication in addressing neurologic disparities and inequities to achieve health equity. We find a need for incentivizing and supporting the application of communication science across the spectrum of neurologic health research. We present recommendations for NINDS and individual investigators to support communication activities that advance neurologic health equity., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.)

Abstract: Many questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care. This article summarizes methodological considerations for pragmatic trials, mainly concerning methods of fundamental importance to the internal validity of trials. The relationship between these methods and common pragmatic trials methods and goals is considered, recognizing that the resulting trial designs are highly dependent on the specific research question under investigation. The basis of this statement was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) systematic review of methods and a consensus meeting. The meeting was organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership. The consensus process was informed by expert presentations, panel and consensus discussions, and a preparatory systematic review. In the context of pragmatic trials of pain treatments, we present fundamental considerations for the planning phase of pragmatic trials, including the specification of trial objectives, the selection of adequate designs, and methods to enhance internal validity while maintaining the ability to answer pragmatic research questions., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)

Pain catastrophizing is understood as a negative cognitive and emotional response to pain. Researchers, advocates and patients have reported stigmatizing effects of the term in clinical settings and the media. We conducted an international study to investigate patient perspectives on the term pain catastrophizing. Open-ended electronic patient and caregiver proxy surveys were promoted internationally by collaborator stakeholders and through social media. 3,521 surveys were received from 47 countries (77.3% from the U.S.). The sample was mainly female (82.1%), with a mean age of 41.62 (SD 12.03) years; 95% reported ongoing pain and pain duration > 10 years (68.4%). Forty-five percent (n = 1,295) had heard of the term pain catastrophizing; 12% (n = 349) reported being described as a 'pain catastrophizer' by a clinician with associated high levels of feeling blamed, judged, and dismissed. We present qualitative thematic data analytics for responses to open-ended questions, with 32% of responses highlighting the problematic nature of the term. We present the patients' perspective on the term pain catastrophizing, its material effect on clinical experiences, and associations with negative gender stereotypes. Use of patient-centered terminology may be important for favorably shaping the social context of patients' experience of pain and pain care. PERSPECTIVE: Our international patient survey found that 45% had heard of the term pain catastrophizing, about one-third spontaneously rated the term as problematic, and 12% reported the term was applied to them with most stating this was a negative experience. Clinician education on patient-centered terminology may improve care and reduce stigma., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

For individuals experiencing pain, the decision to engage in clinical trials may be influenced by a number of factors including current and past care, illness severity, physical functioning, financial stress, and caregiver support. Co-occurring depression and anxiety may add to these challenges. The aim of this scoping review was to describe perspectives about clinical trial participation, including recruitment and retention among individuals with pain and pain comorbidities, including depression and/or anxiety. We searched PubMed, CINAHL, PsycINFO, and Cochrane CENTRAL databases. Study features, sample demographics, perspectives, barriers and/or motivations were collected and described. A total of 35 assessments were included in this scoping review with 24 focused on individuals with pain (24/35, 68.6%), 9 on individuals with depression and/or anxiety (9/35, 25.7%), and 2 on individuals with pain and co-occurring depression/anxiety (2/35, 5.7%). Barriers among participants with pain and those with depression included: research team's communication of information, fear of interventional risks, distrust (only among respondents with pain), too many procedures, fear of inadequate treatment, disease-life stressors, and embarrassment with study procedures (more commonly reported in participants with depression). Facilitators in both groups included: altruism and supportive staff, better access to care, and the ability to have outcome feedback (more commonly among individuals with depression). Individuals with pain and depression experience challenges that affect trial recruitment and retention. Engaging individuals with pain within research planning may assist in addressing these barriers and the needs of individuals affected by pain and/or depression. PERSPECTIVE: This review highlights the need to address barriers and facilitators to participation in clinical trials, including the need for an assessment of perspectives from underserved or marginalized populations., (Copyright © 2022 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: Misapplication of the 2016 Centers for Disease Control (CDC) opioid prescribing guidelines has led to overem-phasis of morphineequivalent daily dose (MEDD) as a "metric of success" in chronic noncancer pain (CNCP), resulting in unintentional harms to patients. This article reviews CNCP-related guidelines and patient preferences in order to identify pragmatic, patient-centered metrics to assess treatment response and safety in opioid-treated CNCP., Methods: We reviewed the clinical (CDC), research (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials), and implementability-related guidelines (GuideLine Implementability Appraisal), along with relevant patient-identified treatment goals. From these, we summarize a guideline-concordant, patient-centered, implementable set of measures to aid the clinical management of opioid-treated CNCP., Results: We identify metrics across three domains of care: (1) treatment response metrics, which align with the CNCP care goals (pain intensity, pain interference including function and quality of life, and global impression of change); (2) risk assessment ("safety") metrics, eg, MEDD, benzodiazepine-opioid or naloxone-opioid coprescribing, and severity of mental health disorders, which evaluate the risk-benefit profile of opioid therapy; and (3) adherence ("process") metrics, which assess clinician/patient adherence to the guideline-recommended opioid therapy monitoring practices, eg, the presence of completed treatment agreement or urine toxicology testing. All metrics should be informed by implementability principles, eg, be decidable, executable, and measurable., Conclusions: This article summarizes guideline-concordant, patient-centered, implementable metrics for assessing treatment response, safety, and adherence in opioid-treated CNCP. Regardless of which specific treatment guidelines are applied, this approach could help conceptualize and standardize the collection and reporting of CNCP-relevant metrics, compare them across health systems, and optimize care and treatment outcomes in opioid-treated CNCP.

Abstract: The interest and the rationale for meaningful engagement of patients as partners in clinical trials of pain treatments has been increasing. No specific guidance on patient engagement for pain research studies currently exists; thus, the goal of this narrative review was to provide a historical perspective and a current evaluation of the literature on engaging patients as partners in clinical studies in general and in pain-related studies more specifically. We described how regulatory and funding agencies have developed approaches to incorporate input from patients and patient partners in their decision-making processes. We provided an overview on key practices of patient recruitment and engagement as partners in clinical research and highlighted the perceived benefits and challenges of such partnerships. We summarized factors that can facilitate or hinder meaningful patient engagement in clinical trials of pain treatments and outlined gaps that future research should address to optimize patient-centered clinical research., (Copyright © 2022 International Association for the Study of Pain.)

Over twenty years have passed since JLME published "The Girl Who Cried Pain: A Bias Against Women in the Treatment of Pain." This article revisits the conclusions drawn in that piece and explores what we have learned in the last two decades regarding the experience of men and women who have chronic pain and whether women continue to be treated less aggressively for their pain than men.

Summaries of the articles included in part II of the ACTTION Guide to Clinical Trials of Pain Treatments are followed by brief overviews of methodologic considerations involving precision pain medicine, pragmatic clinical trials, real world evidence, and patient engagement in clinical trials., Competing Interests: The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration (FDA) has provided financial support for the preparation, publication, and distribution of this series of articles. ACTTION has received research grants, contracts, and other support from the FDA, multiple pharmaceutical and device companies, philanthropy, royalties, and other sources (a list of ACTTION's industry sponsors is available at http://www.acttion.org/partners).Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.)

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 measures for chronic pain treatments that are recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) or other expert groups, and (3) review advances in understanding pain-related COAs that are relevant to clinical trials. The authors reviewed relevant articles, chapters, and guidance documents from the European Medicines Agency and U.S. Food and Drug Administration. Since the original core set of outcome measures were recommended by IMMPACT 14 years ago, several new advancements and publications relevant to the measurement or interpretation of COAs for chronic pain trials have emerged, presenting new research opportunities. Despite progress in the quality of measurement of several outcome domains for clinical trials of chronic pain, there remain some measurement challenges that require further methodological investigation., Competing Interests: D. Amtmann and M.P. Jensen participated in the development of the Patient Reported Outcomes Measurement Information System (PROMIS) pain interference measure, but did not receive any royalty payments for that work. M.P. Jensen codeveloped the Pain Quality Assessment Scale (PQAS) that is reviewed in this article, and receives royalties from licensing fees paid by funded researchers who use the measure (clinicians and unfunded researchers can use the PQAS without paying a licensing fee). D.C. Turk codeveloped the Multidimensional Pain Inventory (MPI) and the second short-form McGill Pain Questionnaire (SF-MPQ-2), but does not receive any royalty payments for the use of these measures. The remaining authors have no conflict of interest to declare.Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.)

Pain medication plays an important role in the treatment of acute and chronic pain conditions, but some drugs, opioids in particular, have been overprescribed or prescribed without adequate safeguards, leading to an alarming rise in medication-related overdose deaths. The NIH Helping to End Addiction Long-term (HEAL) Initiative is a trans-agency effort to provide scientific solutions to stem the opioid crisis. One component of the initiative is to support biomarker discovery and rigorous validation in collaboration with industry leaders to accelerate high-quality clinical research into neurotherapeutics and pain. The use of objective biomarkers and clinical trial end points throughout the drug discovery and development process is crucial to help define pathophysiological subsets of pain, evaluate target engagement of new drugs and predict the analgesic efficacy of new drugs. In 2018, the NIH-led Discovery and Validation of Biomarkers to Develop Non-Addictive Therapeutics for Pain workshop convened scientific leaders from academia, industry, government and patient advocacy groups to discuss progress, challenges, gaps and ideas to facilitate the development of biomarkers and end points for pain. The outcomes of this workshop are outlined in this Consensus Statement.

Competing Interests: Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Unlabelled: National Pain Strategy population research objectives include: estimating chronic pain prevalence, studying pain treatment with electronic health care data, and developing metrics to assess progress in reducing chronic pain impact. In this article, the National Pain Strategy Population Research Workgroup reviews concepts relevant to achieving these aims. High-impact chronic pain was defined as persistent pain with substantial restriction of life activities lasting 6 months or more. In pilot work, we tested a brief assessment of high-impact chronic pain, and used electronic health records data to describe pain-related health care. A mail survey of adult health plan enrollees (N = 770) reported that 14% had high-impact chronic pain. Relative to persons with lower-impact chronic pain, those with high-impact chronic pain were more often frequent users of health care for pain, reported lower quality of life, greater pain-related interference with activities, and more often reported pain at multiple anatomic locations. Analyses of health care data (N = 289,464) reported that pain patients had higher health care costs compared with others and that pain services were typically delivered in primary care. These results support the feasibility of developing data on chronic pain through national health interview surveys and large electronic health care databases., Perspective: Pilot analyses supported the feasibility of brief chronic pain assessments suitable for national health surveys and use of electronic health care databases to develop data regarding trends in the delivery of pain treatments, costs, and effectiveness. These methods are relevant to achieving the aims of the US National Pain Strategy., (Copyright © 2016 American Pain Society. All rights reserved.)

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, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.

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 combinations, for individual patients) that would presumably improve both the clinical care of patients with pain and the success rates for putative analgesic drugs in phase 2 and 3 clinical trials. However, before implementing this approach, the characteristics of individual patients or subgroups of patients that increase or decrease the response to a specific treatment need to be identified. The challenge is to identify the measurable phenotypic characteristics of patients that are most predictive of individual variation in analgesic treatment outcomes, and the measurement tools that are best suited to evaluate these characteristics. In this article, we present evidence on the most promising of these phenotypic characteristics for use in future research, including psychosocial factors, symptom characteristics, sleep patterns, responses to noxious stimulation, endogenous pain-modulatory processes, and response to pharmacologic challenge. We provide evidence-based recommendations for core phenotyping domains and recommend measures of each domain.

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.

Objective: To create a national registry for the study of vulvodynia in order to enhance classification of vulvodynia based on multiple phenotypic domains such as pain characteristics, clinical examination, sexual function, psychological functioning, and distress., Study Design: Methodology for this prospective cohort registry was institutional review board approved and implemented at 8 enrollment sites starting in 2009. Women underwent gynecologic evaluation and pressure sensory testing for assessment of pain sensitivity in the vaginal mucosa and vaginal muscles. Psychometric questionnaires were used to assess self-described pain, distress, sexual function, and quality of life., Results: More than 300 women were enrolled and 176 charts were analyzed. This cohort had a median age of 29 years and median pain duration of 25.5 months. A total of 84% of participants were previously or currently sexually active in spite of pain. The most common pain comorbidities reported by the women were migraines (34%), chronic pelvic pain (22%), and irritable bowel syndrome (20%). Anxiety affected 41% of the cohort. More than 90% presented with localized vestibular pain, and 90% had muscular examination abnormalities., Conclusion: A national registry for the study of vulvodynia was established with successful enrollment of participants at 8 sites. In addition to the cotton swab evaluation for vulvar allodynia, women with vulvar chronic pain should also be routinely screened for musculoskeletal dysfunction, emotional distress with specific emphasis on anxiety, and comorbid pain conditions.

Objective: To assess women's likelihood of feeling comfortable in discussing vulvar pain., Study Design: Using a survey of women with self-reported clinician-diagnosed vulvodynia, we assessed the likelihood of comfort in discussing vulvar pain within four types of relationships: husband/partner, mother/sister, best friend, and other women friends. Separate multivariable models were fit for relationship type to determine whether vulvar pain characteristics (length, severity,family history) were associated with likelihood of feeling comfortable in discussing., Results: A total of 67% of women with a partner were comfortable discussing their vulvar pain with that person, whereas 39% were comfortable with family and 26% were comfortable with women friends. Independent of age, the more years women had vulvodynia the less likely they would be comfortable discussing it. Compared to lower levels of vulvar pain, increasing levels (mild, moderate and severe) were associated with greater comfort in discussing their pain with friends; women were 10% more likely to be comfortable with each increase in pain level, and 12% more likely to be comfortable with other women friends., Conclusion: Our data suggest that vulvar pain characteristics may determine how comfortable a woman is to discuss her vulvar pain, but it varies by relationship type.

Many women with vulvodynia also suffer from other chronic co-morbid pain conditions. Alone, these pain conditions are associated with feeling invalidated by others and feeling socially isolated. It is unclear, however, how the presence of additional pain co-morbidities are associated with the psychosocial wellbeing of women with vulvodynia. We used data from a survey administered by the National Vulvodynia Association. Women reported clinician-diagnosed vulvodynia, presence of co-morbid pain, and how often they felt that they felt no one believed their pain existed (invalidated) and isolated. Analyses determined prevalence of feeling invalidated or isolated, and the difference in prevalence when co-morbidities existed. Forty-five percent of these 1847 women with vulvodynia reported having at least one of the following five chronic pain conditions, chronic fatigue syndrome, endometriosis, fibromyalgia, interstitial cystitis, or irritable bowel syndrome. Adjusted baseline prevalence among all women of feeling invalidated was 9% and of feeling isolated was 14%. Having a co-morbid condition with vulvodynia, as well as having an increasing number of co-morbid conditions with vulvodynia, was significantly associated with the presence of feeling both invalidated and isolated. Chronic fatigue syndrome was the co-morbidity most strongly associated with feelings invalidation and isolation. One or more co-morbid pain conditions in addition to vulvodynia were significantly associated with psychosocial wellbeing. However, the temporality of the association could not be elucidated and therefore we cannot conclude that these pain conditions cause poor psychosocial wellbeing. Despite this, future studies should explore the utility of promoting validation of women's pain conditions and reducing social isolation for women with chronic pain.

Vulvodynia is a chronic pain syndrome affecting up to 18% of the female population. Despite its high prevalence and associated distress, the etiology, diagnosis and clinical management of the disorder have not been clearly delineated. This "white paper" describes the findings and recommendations of a consensus conference panel based on a comprehensive review of the published literature on vulvodynia in addition to expert presentations on research findings and clinical management approaches. The consensus panel also identified key topics and issues forfurther research, including the role of inflammatory mechanisms and genetic factors and psychosexual contributors.