Development and usability testing of HEARTPA♀N: protocol for a mixed methods strategy to develop an integrated smartphone and web-based intervention for women with cardiac pain.

INTRODUCTION: More women experience cardiac pain related to coronary artery disease and cardiac procedures compared with men. The overall goal of this programme of research is to develop an integrated smartphone and web-based intervention (HEARTPA♀N) to help women recognise and self-manage cardiac pain. METHODS AND ANALYSIS: This protocol outlines the mixed methods strategy used for the development of the HEARTPA♀N content/core feature set (phase 2A), usability testing (phase 2B) and evaluation with a pilot randomised controlled trial (RCT) (phase 3). We are using the individual and family self-management theory, mobile device functionality and pervasive information architecture of mHealth interventions, and following a sequential phased approach recommended by the Medical Research Council to develop HEARTPA♀N. The phase 3 pilot RCT will enable us to refine the prototype, inform the methodology and calculate the sample size for a larger multisite RCT (phase 4, future work). Patient partners have been actively involved in setting the HEARTPA♀N research agenda, including defining patient-reported outcome measures for the pilot RCT: pain and health-related quality of life (HRQoL). As such, the guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols (SPIRIT-PRO) are used to report the protocol for the pilot RCT (phase 3). Quantitative data (eg, demographic and clinical information) will be summarised using descriptive statistics (phases 2AB and 3) and a content analysis will be used to identify themes (phase 2AB). A process evaluation will be used to assess the feasibility of the implementation of the intervention and a preliminary efficacy evaluation will be undertaken focusing on the outcomes of pain and HRQoL (phase 3). ETHICS AND DISSEMINATION: Ethics approval was obtained from the University of Toronto (36415; 26 November 2018). We will disseminate knowledge of HEARTPA♀N through publication, conference presentation and national public forums (Café Scientifique), and through fact sheets, tweets and webinars. TRIAL REGISTRATION NUMBER: NCT03800082.

An Online Cross-Sectional Comparison of Women With Symptoms of Persistent Genital Arousal, Painful Persistent Genital Arousal, and Chronic Vulvar Pain.

BACKGROUND: Persistent genital arousal disorder (PGAD) is an understudied condition characterized by unwanted physiologic genital arousal in the absence of subjective sexual arousal. Markos and Dinsmore (Int J STD AIDS 2013;24:852-858) theorized that PGAD shares a number of similarities with vulvodynia (unexplained chronic vulvar pain [CVP]), including symptom characteristics and comorbidities. AIM: To compare medical histories, symptom characteristics, pain characteristics, and daily functioning among women with persistent genital pain (PGA) (n = 42), painful PGA (n = 37), and CVP (n = 42) symptoms. METHODS: An online cross-sectional survey was conducted from October 2015 through April 2016. OUTCOMES: Self-report measures of symptoms, diagnosed medical conditions, pain characteristics (McGill Pain Questionnaire), catastrophizing (Pain Catastrophizing Scale), and daily functioning (Functional Status Questionnaire) were collected. RESULTS: All 3 groups reported similar medical diagnoses and high frequencies of other chronic pelvic pain conditions. Women in all 3 groups reported comparable ages at symptom onset and timing of symptom expression (ie, constant vs intermittent). Women in the 2 PGA groups reported significantly greater feelings of helplessness than women in the CVP group. Women in the painful PGA and CVP groups endorsed significantly more sensory terms to describe their symptoms compared with women in the PGA group, whereas women in the painful PGA group reported significantly more affective terms to describe their symptoms compared with women in the CVP group. Women in the 2 PGA groups reported that their symptoms interfered significantly with most areas of daily functioning. CLINICAL IMPLICATIONS: Given the similarities between PGA and CVP symptoms, women with PGA may benefit from similar assessment, treatment, and research approaches. STRENGTHS AND LIMITATIONS: Limitations of the present study include its sole use of self-report measures; the presence of PGA or CVP symptoms was not confirmed by clinical assessment. However, the anonymous design of the online survey could have resulted in a larger and more diverse sample. CONCLUSION: The results of this study provide some initial support for the conceptualization of persistent genital arousal as a subtype of genital paresthesias/discomfort. These results also further highlight the negative impact that PGA symptoms have on many domains of daily living and the need for further research on this distressing condition. Jackowich RA, Pink L, Gordon A, et al. An Online Cross-Sectional Comparison of Women With Symptoms of Persistent Genital Arousal, Painful Persistent Genital Arousal, and Chronic Vulvar Pain. J Sex Med 2018;15:558-567.

Symptom Characteristics and Medical History of an Online Sample of Women Who Experience Symptoms of Persistent Genital Arousal.

Persistent genital arousal disorder (PGAD; Leiblum & Nathan, 2001 ) is characterized by distressing symptoms suggestive of genital arousal in the absence of subjective feelings of arousal. Although awareness of PGAD is growing, there continues to be a lack of systematic research on it. This study characterized an online sample of women with symptoms of persistent genital arousal (PGA) in terms of their symptom characteristics, medical comorbidities, symptom triggers, management strategies, and predictors of distress. Women reported diverse PGA symptoms, with almost half reporting painful symptoms, and most reported very high distress and negative emotions. Further research and awareness of PGA are needed to provide effective care for this population.

Persistent Genital Arousal Disorder: A Review of Its Conceptualizations, Potential Origins, Impact, and Treatment.

INTRODUCTION: Persistent genital arousal disorder (PGAD) is a condition characterized by symptoms of physiologic (typically genital) sexual arousal in the absence of perceived subjective sexual arousal. The physiologic arousal can last hours or days, or it can occur constantly, and it does not typically remit after orgasm(s). The symptoms are usually described as distressing, intrusive, and unwanted. AIM: To review the available literature on PGAD. METHODS: A literature review through April 2016 was undertaken using terms persistent genital arousal disorder, persistent sexual arousal syndrome, and restless genital syndrome. MAIN OUTCOME MEASURES: The main outcome is a review of the conceptualization of PGAD, its prevalence, proposed etiologies and treatments, and its impact on psychosocial and sexual functioning. RESULTS: Much of the research on the potential etiologies and treatments of PGAD is published in the form of case studies. Several etiologies of PGAD have been proposed; however, a cause or causes have not been confirmed. A range of treatments has been explored primarily in case studies, from electroconvulsive therapy to oral medication, with variable success rates. Psychologically based treatments have been suggested but have yet to be evaluated. Online surveys have found initial evidence supporting the negative impact of PGAD on mental health and sexual functioning; however, more research is needed in this area. CONCLUSION: Although PGAD was first conceptualized 15 years ago, it remains a very under-researched condition. Currently, little is known about its biopsychosocial correlates, etiologies, or successful treatments. Future research directions are identified.

Clitorodynia: A Descriptive Study of Clitoral Pain.

INTRODUCTION: Clitorodynia is classified as a type of localized vulvodynia. Our knowledge of this problem is limited to case studies and one published report. AIMS: The objective of the present study was to describe quantitatively the clinical characteristics of clitoral pain, to assess interference with sexual function, and to investigate whether clitoral pain is a unitary category. METHODS: One hundred twenty-six women with clitoral pain completed an online questionnaire that assessed demographic information, descriptive pain characteristics, intensity and impact on daily activities, sexual function, and gynecological and medical histories. MAIN OUTCOME MEASURES: The main outcome measures used for the study are the following: clitoral pain characteristics (e.g., intensity, duration, quality, distress, etc.), short-form McGill pain questionnaire-2, and the female sexual function index. RESULTS: Clitoral pain is characterized by frequent and intense pain episodes that can either be provoked or unprovoked, and causes significant impairment in both daily and sexual function. The pain can be localized to the clitoris only or can occur with other genital pain. Comorbidity with other chronic pain disorders is common. A cluster analysis suggested two distinct patterns of clitoral pain, one localized and one generalized. CONCLUSION: Our findings indicate that women with clitoral pain suffer from significant, distressing, and often long-term pain, which interferes with sexual and daily activities. Two subtypes of clitoral pain may exist, each with distinct pain characteristics and subjective experiences.

iCanCope with Pain™: User-centred design of a web- and mobile-based self-management program for youth with chronic pain based on identified health care needs.

BACKGROUND: While there are emerging web-based self-management programs for children and adolescents with chronic pain, there is currently not an integrated web- and smartphone-based app that specifically addresses the needs of adolescents with chronic pain. OBJECTIVES: To conduct a needs assessment to inform the development of an online chronic pain self-management program for adolescents, called iCanCope with Pain™. METHODS: A purposive sample of adolescents (n=23; 14 to 18 years of age) was recruited from two pediatric chronic pain clinics in Ontario. Interdisciplinary health care providers were also recruited from these sites. Three focus groups were conducted with adolescents (n=16) and one with pediatric health care providers (n=7). Individual adolescent interviews were also conducted (n=7). RESULTS: Qualitative analysis uncovered four major themes: pain impact; barriers to care; pain management strategies; and transition to adult care. Pain impacted social, emotional, physical and role functioning, as well as future goals. Barriers to care were revealed at the health care system, patient and societal levels. Pain management strategies included support systems, and pharmacological, physical and psychological approaches. Transition subthemes were: disconnect between pediatric and adult systems; skills development; parental role; and fear/anxiety. Based on these identified needs, the iCanCope with Pain™ architecture will include the core theory-based functionalities of: symptom self-monitoring; personalized goal setting; pain coping skills training; peer-based social support; and chronic pain education. CONCLUSIONS: The proposed iCanCope with Pain™ program aims to address the self-management needs of adolescents with chronic pain by improving access to disease information, strategies to manage symptoms and social support.

Development, implementation and evaluation of a pain management and palliative care educational seminar for medical students.

BACKGROUND: Despite calls for the development and evaluation of pain education programs during early medical student training, little research has been dedicated to this initiative. OBJECTIVES: To develop a pain management and palliative care seminar for medical students during their surgical clerkship and evaluate its impact on knowledge over time. METHODS: A multidisciplinary team of palliative care and pain experts worked collaboratively and developed the seminar over one year. Teaching methods included didactic and case-based instruction, as well as small and large group discussions. A total of 292 medical students attended a seminar during their third- or fourth-year surgical rotation. A 10-item test on knowledge regarding pain and palliative care topics was administered before the seminar, immediately following the seminar and up to one year following the seminar. Ninety-five percent (n=277) of students completed the post-test and 31% (n=90) completed the follow-up test. RESULTS: The mean pretest, post-test and one-year follow-up test scores were 51%, 75% and 73%, respectively. Mean test scores at post-test and follow-up were significantly higher than pretest scores (all P<0.001). No significant difference was observed in mean test scores between follow-up and post-test (P=0.559), indicating that students retained knowledge gained from the seminar. CONCLUSIONS: A high-quality educational seminar using interactive and case-based instruction can enhance students' knowledge of pain management and palliative care. These findings highlight the feasibility of developing and implementing pain education material for medical students during their training.

Persistent genital arousal in women with pelvic and genital pain.

OBJECTIVE: Persistent genital arousal disorder (PGAD) has been identified as a condition of often unprovoked genital arousal associated with a significant level of distress. PGAD is not well understood, and no definitive cause has been determined. The aim of this study was to gain a better understanding of the disorder and to seek commonalities between cases of PGAD encountered in a chronic pain management clinic. METHOD: We reviewed a cohort of 15 women with PGAD who presented to a chronic non-cancer pain clinic in a large urban tertiary teaching hospital that provides pelvic and genital pain management. We conducted a series of interviews to examine medical history, history of presenting illness, and management. Descriptive statistics were used to examine the data. RESULTS: Findings were largely consistent with previous research on PGAD regarding symptomatology and aggravating and alleviating factors. Symptoms of genital pain, depression, and interstitial cystitis were found in over one half of the patients in this cohort. Previous antidepressant use, restless legs syndrome, and pudendal neuralgia were found in a number of cases. Pelvic varices and Tarlov cysts have been previously identified as possible contributors to PGAD, but these were not a common finding in our cohort. CONCLUSION: Further research is needed to build on the current understanding of PGAD. Patients should be asked about persistent arousal as part of a sexual and reproductive history, especially in the case of common comorbidities.

Objectif : Le syndrome d'excitation génitale persistante (SEGP) a été identifié comme étant une excitation génitale souvent non provoquée qui est associée à un degré de détresse considérable. Le SEGP n'est pas bien compris et aucune cause définitive ne lui a été attribuée. Cette étude avait pour but d'améliorer la compréhension de ce syndrome et de tenter d'établir des points communs entre les cas de SEGP constatés au sein d'une clinique de maîtrise de la douleur chronique. Méthode : Nous avons analysé une cohorte de 15 femmes aux prises avec le SEGP qui ont consulté une clinique de maîtrise de la douleur chronique n'étant pas attribuable au cancer, au sein d'un hôpital universitaire tertiaire urbain de grande envergure qui offre des services de maîtrise de la douleur pelvienne et génitale. Nous avons mené une série d'entrevues visant à examiner les antécédents médicaux, l'historique de la maladie en question et la prise en charge. Nous avons eu recours aux principes de la statistique descriptive pour examiner les données. Résultats : Nos constatations se sont en grande partie inscrites dans la suite logique des résultats obtenus par les efforts de recherche précédents ayant porté sur le SEGP, en ce qui a trait à la symptomatologie et aux facteurs aggravants et atténuants. Des symptômes de douleur génitale, de dépression et de cystite interstitielle ont été constatés chez plus de la moitié des patientes de cette cohorte. Des antécédents en matière d'utilisation d'antidépresseurs, de syndrome des jambes sans repos et de névralgie pudendale ont été constatés dans un certain nombre de cas. Des varices pelviennes et des kystes de Tarlov ont déjà été identifiés comme étant de possibles facteurs contribuant au SEGP; toutefois, leur présence n'a pas été fréquemment signalée au sein de notre cohorte. Conclusion : La tenue d'autres recherches s'avère requise pour enrichir notre compréhension actuelle du SEGP. Dans le cadre de l'anamnèse sexuelle et génésique, des questions portant sur l'excitation persistante devraient être posées aux patientes, particulièrement en présence de comorbidités courantes.

Music as a sleep aid in fibromyalgia.

BACKGROUND: Interventions to improve sleep in fibromyalgia may generalize to improvements in multiple symptom domains. Delta-embedded music, pulsating regularly within the 0.25 Hz to 4 Hz frequency band of brain wave activity, has the potential to induce sleep. OBJECTIVES: To assess the effects of a delta-embedded music program over four weeks for sleep induction in patients with fibromyalgia. METHODS: The present unblinded, investigator-led pilot study used a within-subject design. Analysis was based on 20 individuals with fibromyalgia who completed the study, of the 24 recruited into the study. The primary outcome variables were the change from baseline in Fibromyalgia Impact Questionnaire (FIQ) and Jenkins Sleep Scale scores. A patient global impression of change was measured on a seven-point Likert scale. Secondary outcome measures, comprised of items 5, 6 and 7 of the FIQ, were used as indicators of pain, tiredness and being tired on awakening. RESULTS: The FIQ median score of 76.4 (95% CI 61.3 to 82.1) at baseline improved to 60.3 (95% CI 53.1 to 72.0; P=0.004). The Jenkins Sleep Scale median value of 17.5 (95% CI 15.5 to 18.5) at baseline fell to 12.5 (95% CI 8.5 to 14.5; P=0.001) at study completion. The outcomes of the patient global impression of change ratings were mostly positive (P=0.001). Being tired on awakening declined significantly from a median of 9.0 (95% CI 8.0 to 10.0) to 8.0 (95% CI 5.5 to 9.0; P=0.021). However, there was no significant improvement in pain level (baseline median 7.5 [95% CI 7.0 to 8.5] versus study completion median 7.0 [95% CI 6.5 to 8.0]; P=0.335) or tiredness (baseline median 9.0 [95% CI 8.0 to 9.5] versus study completion median 8.0 [95% CI 6.0 to 8.5]; P=0.061). There were no serious adverse events. CONCLUSIONS: Delta-embedded music is a potential alternative therapy for fibromyalgia.

Evaluation of the frequency and the association of sexual pain and chronic headaches.

BACKGROUND: Sexual pain and chronic headaches are both complex conditions with associated high disability. Little research has examined whether there is a relationship between the 2. The aim of this survey-based study was to explore the frequency of sexual pain in a population of women being treated for chronic headache. Peripheral aims included exploring the number of patients receiving treatment for sexual pain and the association between sexual pain and libido, and history of abuse. METHODS: Patients presenting to an ambulatory chronic headache clinic were administered a short 10-item survey. RESULTS: Forty-four percent of patients reported that they had pelvic region or genital pain brought on by sexual activity. Only half of these patients had ever discussed their pelvic pain with a health care provider, and 31% of these patients had not received treatment. Almost all patients would be interested in treatment if available. Seventy-five percent of patients indicated a change in libido. CONCLUSION: Chronic headaches and sexual pain are both conditions that have a significant impact on patients and the health care system, and they do coexist. More research is needed to look at the relationship between these conditions in addition to epidemiology, symptomatology, evaluation, and treatments.

Understanding the information and service needs of young adults with chronic pain: perspectives of young adults and their providers.

OBJECTIVE: To qualitatively explore the information and service needs of young adults (YAs) with chronic pain to inform the development of a web-based chronic pain self-management program. METHODS: A convenience sample of YAs (n=17; aged 18 to 29 y) with chronic pain was recruited from 2 adult tertiary care multidisciplinary chronic pain clinics in Ontario. Interdisciplinary health care professionals who had worked in chronic pain for at least 1 year were also recruited from these sites. Five audiotaped focus groups were conducted, 3 for YAs and 2 for health care professionals. Transcribed data were organized into categories that reflected emerging themes. RESULTS: Findings uncovered 4 major themes: (1) pain impact, (2) pain management strategies, (3) barriers to care, and (4) service delivery recommendations. Subthemes were found under each major theme. Pain had an impact on social and emotional realms and role functioning, physical functioning, and future vocational and life goals. Pain management strategies were comprised of psychological, physical, and pharmacological approaches and development of support systems. Barriers to care were revealed at the patient, health care system, and societal levels. Finally, service delivery recommendations were divided into 2 subthemes pertaining to improved services and Internet-based programs. DISCUSSION: Participants unanimously felt that a web-based program would be an acceptable means to help improve access to services and meet the need for more information about chronic pain, strategies to manage pain symptoms, and social support to address the unique developmental needs of YAs.

Intake assessment of problematic use of medications in a chronic noncancer pain clinic.

BACKGROUND: The present article outlines the process of instituting an assessment of risk of problematic use of medications with new patients in an ambulatory chronic noncancer pain (CNCP) clinic. It is hoped that the authors' experience through this iterative process will fill the gap in the literature by setting an example of an application of the 'universal precautions' approach to chronic pain management. OBJECTIVES: To assess the feasibility and utility of the addition of a new risk assessment process and to provide a snapshot of the risk of problematic use of medications in new patients presenting to a tertiary ambulatory clinic treating CNCP. METHODS: Charts for the first three months following the institution of an intake assessment for risk of problematic medication use were reviewed. Health care providers at the Wasser Pain Management Centre (Toronto, Ontario) were interviewed to discuss the preliminary findings and provide feedback about barriers to completing the intake assessments, as well as to identify the items that were clinically relevant and useful to their practice. RESULTS: Data were analyzed and examined for completeness. While some measures were considered to be particularly helpful, other items were regarded as repetitive, problematic or time consuming. Feedback was then incorporated into revisions of the risk assessment tool. DISCUSSION: Overall, it is feasible and useful to assess risk for problematic use of medications in new patients presenting to CNCP clinics. CONCLUSION: To facilitate the practice of assessment, the risk assessment tool at intake must be concise, clinically relevant and feasible given practitioner time constraints.

Examination of migraine management in emergency departments.

BACKGROUND: Despite advances in treatment, patients with migraine have been underdiagnosed and undertreated, specifically in emergency departments. In addition, great variability exists with respect to the diagnosis, management and treatment of migraine patients in emergency departments. In particular, migraine-specific treatments, including serotonin receptor agonists, appear to be rarely used. OBJECTIVE: To examine the diagnosis and management of migraine patients within Ontario emergency departments. METHODS: A prospective survey was designed to inquire how emergency physicians diagnose and manage patients with migraine. Questions focused on the use of serotonin receptor agonists, the rationale behind their use or nonuse, and acute headache protocols. The survey also inquired about the use of International Classification Of Headache Disorders-2 criteria in diagnosing migraine by emergency physicians, medication prescribed on discharge, and referrals made to outpatient specialists. These surveys were distributed to and anonymously completed by emergency physicians in several departments in Ontario. RESULTS: Migraine-specific treatments were underused in emergency departments. Furthermore, many departments lacked headache protocols and, often, migraine-specific treatment was not included in the few departments with protocols. CONCLUSIONS: Diagnosis and management of migraines can be improved within emergency departments, and patients can be more effectively channelled toward appropriate outpatient care.

Gone South: why canadian nurses migrate to the United States.

The movement of Canadian nurses to the United States increased over the past decade and is an ongoing concern of health policy analysts. This study examines why Canadian nurses emigrate to the United States and whether there is interest in returning to work in Canada. A survey of Canadian-educated nurses in North Carolina showed that lack of full-time work opportunities played a key role in emigration. Focus groups of respondents revealed deep dissatisfaction with many aspects of nursing practice in Canada, particularly undervaluing of the profession. There is an urgent need for healthcare policy makers to explore what should be done to reduce the loss of this critical human resource.

Outcomes of interventions to improve hospital nursing work environments.

OBJECTIVE: The impact of interventions designed to improve the nursing work environment on patient and nurse outcomes was examined. BACKGROUND: Nursing work environments have been characterized as contributing to patient outcomes as a result of organizational management practices, workforce deployment, work design, and organizational culture. METHODS: This quasi-experimental study involved 16 unit managers, 1,137 patients, and 296 observations from registered nurses over time. RESULTS: After participation in the intervention, study nurses reported higher perceptions of their work and work environment. Demographic nurse, unit, and hospital characteristics also had an impact on the work environment and outcomes. CONCLUSIONS: Findings in this study highlight the importance of understanding factors in the work environment that influence patient and nurse outcomes.

Teaching and community hospital work environments.

The Institute of Medicine report suggests that nursing work environments experience threats to patient safety related to organizational management and workforce deployment practices, work design, and organizational culture. Organizational factors contribute to nursing and potentially patient outcomes, yet few studies have examined the differences in practices perceived by nurses employed in different settings. Nurses from 16 medical and surgical units in eight randomly selected acute care hospitals representing teaching and community organizations participated in this project. Nurses working in teaching hospitals reported lower levels of role tension, yet their perceptions of the quality of work, the work environment, nursing unit leadership, quality of care, and levels of job stress and job satisfaction were higher than their colleagues in the community sites. This study highlights some important differences between teaching and community hospitals that can inform nurse executives and policy makers of the unique work-life issues for different groups of nurses.

Decision making for nurse staffing: Canadian perspectives.

The effectiveness of methods for determining nurse staffing is unknown. Despite a great deal of interest in Canada, efforts conducted to date indicate that there is a lack of consensus on nurse staffing decision-making processes. This study explored nurse staffing decision-making processes, supports in place for nurses, nursing workload being experienced, and perceptions of nursing care and outcomes in Canada. Substantial information was provided from participants about the nurse staffing decision-making methods currently employed in Canada including frameworks for nurse staffing, nurse-to-patient ratios, workload measurement systems, and "gut" instinct. A number of key themes emerged from the study that can form the basis for policy and practice changes related to determining appropriate workload for nursing in Canada. These include the use of (a) staffing principles and frameworks, (b) nursing workload measurement systems, (c) nurse-to-patient ratios, and (d) the need for uptake of evidence related to nurse staffing.