Gender Socialization as a Predictor of Psychosocial Well-Being in Young Women with Breast Cancer.

This study aimed to explore the relationship between gender socialization and psychosocial well-being among young women diagnosed with and treated for breast cancer. A total of 113 women between the ages of 18-49 completed a one-time questionnaire package. Four key measures of gender socialization were included: Gender Role Socialization Scale (GRSS), Objectified Body Consciousness Scale (OBCS), Mental Freedom Scale (MFS), and Silencing the Self Scale (SSS). Two measures of psychosocial well-being were included: Functional Assessment of Cancer Therapy-Breast (FACT-B) and Experience of Embodiment Scale (EES). Correlational and regression analyses were conducted to assess the relationship between gender socialization variables and well-being. In multiple regression models, GRSS and MFS added significant increments to the prediction of variance of the FACT-B (R2 = 23.0%). In contrast, the OBCS and MFS added significant increments to the prediction of variance of the EES (R2 = 47.0%). Findings suggested that women with greater endorsements to proscribed gender socialization were associated with poor well-being scores. Women who endorsed a critical stance, resisting traditional gender-role expectations, objectification pressures, and other social discourses, were associated with greater well-being scores. Future studies are needed to examine the impact of gender socialization on the well-being of young people with breast cancer.

A mental health framework from the voices of refugees.

BACKGROUND: Refugee groups fleeing war and violence and resettling in the West are one of the population groups that are poorly understood. Understanding their mental health challenges and providing effective and evidence-based interventions continue to be formidable challenges. AIM: This study presents a refugee mental health framework [RMHF] that was developed to address the gaps in understanding and responding to the needs of refugee populations by prioritizing their voices, and incorporating lessons learned from working with these refugee communities into the development of the framework. METHOD: A RMHF was developed, presented and refined with input from refugee communities, multiple stakeholders and an expert panel. RESULTS/CONCLUSIONS: This paper presents the process and finalized framework, and discusses its utility as a mapping, planning and intervention tool in supporting refugee communities with their resettlement and promoting mental wellbeing.

Restoring body image after cancer (ReBIC): A group therapy intervention.

OBJECTIVES: Body image (BI) remains a significant survivorship challenge among breast cancer (BC) survivors. We describe an 8-week group intervention-restoring body image after cancer (ReBIC)-developed to target BI distress for BC survivors. METHODS: The intervention was informed by interviews with BC survivors and by a descriptive, exploratory approach which adapted guided imagery exercises to address BI. Educational material was selected to address sociocultural factors that may contribute to BI distress and affect adjustment. Videotape reviews and content analyses further refined the intervention. RESULTS: The intervention incorporates three active components: psychotherapeutic group principles; guided imagery exercises to address BI; and psychoeducation on relevant socialization factors and gender-based messages internalized by women in Western society. The therapeutic group was a supportive and effective way to assist BC survivors to gain insight on BI impacts, their histories, and relevant sociocultural factors contributing to BI distress. The group also facilitated the working through of grief over multiple losses. Guided imagery was well-received, and appeared to help survivors identify negative and emerging self-schema, as well as facilitate new self-views. Specific themes included negative emotions associated with an altered body and self, grief and loss, isolation, difficulties with sexual intimacy, relationship challenges, and uncertainty around sense of self and future. CONCLUSION: An empirically tested group therapy intervention is described and has implications for survivorship programs to help address BI-related challenges. Future work could consider testing a similar approach tailored for other cancer populations.

de Souza interprofessional practice cancer competency framework.

PURPOSE: As the demand in cancer care continues to increase, health systems require a workforce of highly educated specialists and generalists to provide continuity of care across settings. OBJECTIVES: Led by de Souza Institute in Canada, an interdisciplinary working group was formed to develop a competency framework with relevance across regulated health professionals involved in cancer care. METHODS: The working group was presented with results from a scoping review of national and international guidelines, standards, and competencies in oncology, as well as data from needs assessments on continuing education opportunities and oncology topics most relevant to clinicians. Fifty-one professionals from, e.g., family medicine, pharmacy, social work, psychology, occupational therapy, and nursing participated in seven focus groups. An additional 32 nurses participated in a nursing-specific needs assessment survey. Using modified Delphi technique, working group members conducted three iterative rounds to review data and built consensus on competency items in relation to three levels of expertise, from early learner/novice practitioner, advancing practitioner, to expert practitioner. RESULTS: A final consensus was reached for the selection of competencies that reflect optimal cancer care mapped into three levels of expertise, as well as knowledge, skills, and attitudes expected of each level. Examples for the competency for early learner/novice practitioner include the following: Have awareness of common ethical issues in cancer care (knowledge); demonstrate ability to discuss, educate, and counsel patients and their support persons(s) regarding preferences (skills); and appreciate the impact of culture, the sensitivity, and diversity of attitudes in relation to cancer (attitude). Expert practitioner examples include: recognition of need for, and ability to advocate for challenges involving equity and access in order to improve health outcomes (skill) and awareness of workplace complexities, such as provider roles, team functioning, and organizational environments affecting patient-practitioner relationships (attitude). CONCLUSION: The de Souza Interprofessional practice cancer competency framework provides a set of shared competencies and a novice to expert pathway for clinicians across disciplines and supports a more standardized learning and comprehensive approach in organizing professional development towards a coordinated, high quality, and person-centered care.

A randomized controlled trial of a supportive expressive group intervention for women with a family history of breast cancer.

OBJECTIVE: Women with a family history of breast cancer (BC) often overestimate their BC risk. Heightened psychological distress may interfere with risk comprehension and screening adherence. The primary purpose of this study was to test the efficacy of a 12-week manual-based supportive-expressive (SE) group intervention for this population. METHODS: Using a randomized control trial design, this study compared two interventions: a standard risk-counseling arm (RC) compared with that plus SE group intervention. The primary study outcome was BC anxiety. Secondary outcomes included psychosocial functioning, risk comprehension, BC knowledge, and screening behaviors. RESULTS: A total of 161 women with a family history of BC were randomized into SE (N = 108) or RC (N = 53). Participants in both study arms significantly improved on measures of BC anxiety, psychosocial functioning, risk comprehension, and BC knowledge, with no statistical difference between study arms. Benefits were sustained at 1 year. BC screening rates were high in both arms at baseline and follow-up. CONCLUSIONS: SE group therapy as an added intervention to the risk counseling was well-received, however, did not demonstrate superiority to RC alone. Future studies on treatment matching are needed to further our understanding of interventions that can support women with a family history of BC to work through residual issues, including loss and grief.

Restoring Body Image After Cancer (ReBIC): Results of a Randomized Controlled Trial.

Purpose This study aimed to test a group psychosocial intervention focused on improving disturbances of body image (BI), sexual functioning, and quality of life in breast cancer (BC) survivors. Methods A prospective, randomized controlled trial was conducted to assess the efficacy of an 8-week group intervention in women after BC treatment. The manual-based intervention combined two powerful ingredients: expressive guided-imagery exercises integrated within a model of group-therapy principles. The intervention facilitates exploration of identity, the development of new self-schemas, and personal growth. In addition, the intervention included an educational component on the social and cultural factors affecting women's self-esteem and BI. The control condition included standard care plus educational reading materials. One hundred ninety-four BC survivors who had expressed concerns about negative BI and/or difficulties with sexual functioning participated in the study; 131 were randomly assigned to the intervention, and 63 were assigned to the control condition. Participants were followed for 1 year. Results Women in the intervention group reported significantly less concern/distress about body appearance ( P < .01), decreased body stigma ( P < .01), and lower level of BC-related concerns ( P < .01), compared with women in the control group. BC-related quality of life was also better in the intervention group compared with the control group at the 1-year follow-up ( P < .01). There was no statistically significant group difference in sexual functioning. Conclusion Restoring Body Image After Cancer (ReBIC), a group intervention using guided imagery within a group-therapy approach, is an effective method for addressing BI-related concerns and quality of life post-BC. The manual-based intervention can be easily adapted to both cancer centers and primary care settings.

Age, Gender and Women's Health and the Patient.

Patients with functional gastrointestinal disorders (FGIDs) often experience distress, reduced quality of life, a perceived lack of validation, and an unsatisfactory experience with health care providers. A health care provider can provide the patient with a framework in which to understand and legitimize their symptoms, remove self-doubt or blame, and identify factors that contribute to symptoms that the patient can influence or control. This framework is implemented with the consideration of important factors that impact FGIDs, such as gender, age, society, and the patient's perspective. Although the majority of FGIDs, including globus, rumination syndrome, IBS, bloating, constipation, functional abdominal pain, sphincter of Oddi dyskinesia, pelvic floor dysfunction, and extra-intestinal manifestations, are more prevalent in women than men, functional chest pain, dyspepsia, vomiting, and anorectal pain do not appear to vary by gender. Studies suggest sex differences in somatic but not visceral pain perception, motility, and central processing of visceral pain; although further research is required in autonomic nervous system dysfunction, genetics and immunologic/microbiome. Gender differences in response to psychological treatments, antidepressants, fiber, probiotics, and anticholinergics have not been adequately studied. However, a greater clinical response to 5-HT3 antagonists but not 5-HT4 agonists has been reported in women compared with men.

Sexual functioning in breast cancer survivors experiencing body image disturbance.

BACKGROUND: Breast cancer treatments and the traumatic nature of the cancer experience frequently elicit considerable sexual difficulties. Breast cancer survivors (BCS) experiencing body image (BI) issues may represent a vulnerable group for developing sexual dysfunction posttreatment. The current study explores sexual functioning (SF) in this unique clinical group. METHODS: A descriptive study assessed 127 BCS who were engaged in sexual activity. Standardized baseline measures included the following: BI Scale, BI after Breast Cancer Questionnaire, Female Sexual Function Index (FSFI), Kansas Marital Satisfaction Scale, and Functional Assessment of Cancer Therapy - Breast. Levels of SF were compared with BCS, heterogeneous cancer, and healthy female populations. Correlational analyses were conducted between SF, BI, relationship, and health-related quality of life variables. Guided by a conceptual framework, regression analyses were conducted to determine significant demographic, clinical, and psychosocial predictors of sexual desire, satisfaction, and overall SF. RESULTS: Eighty-three per cent of BCS met the FSFI clinical cutoff score for a sexual dysfunction. Participants exhibited poorer SF when compared with other female cancer and healthy groups. No significant correlations were found between BI questionnaire total scores and SF. BI after Breast Cancer Questionnaire - Body Stigma subscale showed significant associations with FSFI Arousal, Orgasm, Satisfaction (average r = -0.23), and overall SF (r = -0.25). Vaginal dryness (ß = -0.50), body stigma (ß = -0.24), and relationship satisfaction (ß = 0.27) were significant predictors of overall SF. CONCLUSION: Difficulties in SF appear to be highly prevalent in BCS experiencing BI disturbance posttreatment. Brief screening tools assessing SF should adopt a biopsychosocial model, which includes questions regarding vaginal dryness, relationship satisfaction, and body stigma issues.

Vaginal birth after caesarean section prediction models: a UK comparative observational study.

OBJECTIVE: Primarily, to assess the performance of three statistical models in predicting successful vaginal birth in patients attempting a trial of labour after one previous lower segment caesarean section (TOLAC). The statistically most reliable models were subsequently subjected to validation testing in a local antenatal population. STUDY DESIGN: A retrospective observational study was performed with study data collected from the Northern Ireland Maternity Service Database (NIMATs). The study population included all women that underwent a TOLAC (n=385) from 2010 to 2012 in a regional UK obstetric unit. Data was collected from the Northern Ireland Maternity Service Database (NIMATs). Area under the curve (AUC) and correlation analysis was performed. RESULTS: Of the three prediction models evaluated, AUC calculations for the Smith et al., Grobman et al. and Troyer and Parisi Models were 0.74, 0.72 and 0.65, respectively. Using the Smith et al. model, 52% of women had a low risk of caesarean section (CS) (predicted VBAC >72%) and 20% had a high risk of CS (predicted VBAC <60%), of whom 20% and 63% had delivery by CS. The fit between observed and predicted outcome in this study cohort using the Smith et al. and Grobman et al. models were greatest (Chi-square test, p=0.228 and 0.904), validating both within the population. CONCLUSION: The Smith et al. and Grobman et al. models could potentially be utilized within the UK to provide women with an informed choice when deciding on mode of delivery after a previous CS.

Do Regular Ultrasound Scans Reduce the Incidence of Stillbirth in Women with Apparently Normal Pregnancies?

OBJECTIVE: To determine the incidence of stillbirth in women who have regular ante-natal ultrasound compared to those that have infrequent scans in a low risk population. STUDY DESIGN: A retrospective observational study was performed in a tertiary center with 5,700 deliveries per annum. Data on all deliveries was collected via the Northern Ireland Maternity System Database. Only women with an apparently low risk pregnancy were included. Women who had private antenatal care often had frequent scans in the third trimester. Women who did not have private antenatal care often had scans infrequently. The still birth rate was calculated for both groups of women from 2007 to 2011 and compared using a Chi-squared analysis. RESULTS: Our study included 23,519 'low-risk' deliveries spanning 2007-2011. This included 2,088 (9%) patients who had frequent ultrasound surveillance and delivery at term and 21,431 (91%) patients who did not. The overall stillbirth rate was 0.34% and 0.20% respectively which was not statistically different (p=0.31). CONCLUSION: There is no difference in the rate of stillbirth between patients who have more frequent ante-natal ultrasound surveillance compared with those who do not in a low risk population.

Intimate Partner Violence and Depression Among Latin American Women in Toronto.

Research from the United States suggests that Latin American immigrant and refugee women are one of the groups most greatly impacted by intimate partner violence (IPV) and associated mental health consequences including higher rates of depression than women from other ethno-racial groups. In Canada, little is known about the experience of IPV and mental health among this population. Even in the broader North American context, how Latin American women themselves perceive the connection between IPV and depression is unknown. This paper presents the findings of a pilot study that examined the perceived relationship between IPV and depression among Spanish-Speaking Latin American Women in Toronto, Canada. The theoretical framework guiding this qualitative study combined an ecological model for understanding gender based violence and mental health with critical intersectionality theory. Using a convenience and snowball sampling method, semi-structured interviews (n = 12) were conducted and thematic content analysis was completed supported by Nvivo9(®) qualitative data management software. All participants had experienced some form of IPV in their adult lives, with psychological violence being the most common. Women perceived a powerful connection between IPV and depression, a link made stronger by the accumulation of other adverse life experiences including childhood abuse, war traumas and migration. The results suggest that IPV is just one of the challenges experienced by Latin American refugee and immigrant women. IPV is experienced in the context of other traumatic experiences and social hardships that may work to intensify the association of IPV and depression in this population.

Predicting why women have elective repeat cesarean deliveries and predictors of successful vaginal birth after cesarean.

OBJECTIVE: To compare the characteristics of women who select elective repeat cesarean rather than trial of labor after cesarean (TOLAC) for delivery, and to determine individual predictors for success and failure within a TOLAC group and observe differences in maternal and neonatal morbidity. METHODS: The present descriptive, retrospective, observational study was performed in a regional obstetric unit in the United Kingdom. Data were collected from the Northern Ireland Maternity System database on all women who gave birth between April 2010 and April 2012, and had a previous cesarean delivery, and statistical analysis was performed. RESULTS: In total, 893 patients were included in the study: 385 underwent TOLAC and 493 underwent elective repeat cesarean. On comparison, women in the elective repeat cesarean group had a shorter inter-delivery interval and fewer had had a previous vaginal delivery (P<0.005). Predictors for success in the TOLAC group included previous vaginal delivery and a longer inter-delivery interval (P<0.05). Successful vaginal birth after cesarean (VBAC) did not have higher rates of maternal morbidity. CONCLUSION: The majority of patients (56%) chose elective repeat cesarean rather than TOLAC, which has long-term implications both clinically and financially. A validated prediction model might improve patient counseling and identify women with a high likelihood of successful VBAC.

Evaluating genetic counseling for individuals with schizophrenia in the molecular age.

BACKGROUND: Recent advances in schizophrenia genetics are shedding new light on etiopathogenesis, but issues germane to translation of findings into clinical practice are relatively understudied. We assessed the need for, and efficacy of, a contemporary genetic counseling protocol for individuals with schizophrenia. METHODS: After characterizing rare copy number variation in a cohort of adults with schizophrenia, we recruited subjects from the majority of individuals who had no clinically relevant structural genetic variant. We used a pre-post study design with longitudinal follow-up to assess both the profile of need and the impact of general genetic counseling on key knowledge-based and psychological factors. RESULTS: Thirty-nine (60.0%) of 65 patients approached actively expressed an interest in the study. At baseline, participants (n = 25) tended to overestimate the risk of familial recurrence of schizophrenia, express considerable concern related to this perceived risk, endorse myths about schizophrenia etiology, and blame themselves for their illness. Postcounseling, there was a significant improvement in understanding of the empiric recurrence risk (P = .0090), accompanied by a decrease in associated concern (P = .0020). There were also significant gains in subjective (P = .0007) and objective (P = .0103) knowledge, and reductions in internalized stigma (P = .0111) and self-blame (P = .0401). Satisfaction with genetic counseling, including endorsement of the need for such counseling (86.4%), was high. CONCLUSIONS: These results provide initial evidence of need for, and efficacy of, genetic counseling for individuals with schizophrenia. The findings may help facilitate development of a contemporary genetic counseling process that could optimize outcomes in the nascent field of evidence-based psychiatric genetic counseling.

Evaluating genetic counseling for family members of individuals with schizophrenia in the molecular age.

BACKGROUND: Myths and concerns about the extent and meaning of genetic risk in schizophrenia may contribute to significant stigma and burden for families. Genetic counseling has long been proposed to be a potentially informative and therapeutic intervention for schizophrenia. Surprisingly, however, available data are limited. We evaluated a contemporary genetic counseling protocol for use in a community mental health-care setting by non-genetics professionals. METHODS: We used a pre-post study design with longitudinal follow-up to assess the impact of genetic counseling on family members of individuals with schizophrenia, where molecular testing had revealed no known clinically relevant genetic risk variant. We assessed the outcome using multiple measures, including standard items and scales used to evaluate genetic counseling for other complex diseases. RESULTS: Of the 122 family members approached, 78 (63.9%) actively expressed an interest in the study. Participants (n = 52) on average overestimated the risk of familial recurrence at baseline, and demonstrated a significant improvement in this estimate postintervention (P < .0001). This change was associated with an enduring decrease in concern about recurrence (P = .0003). Significant and lasting benefits were observed in other key areas, including increased knowledge (P < .0001) and a decreased sense of stigma (P = .0047). Endorsement of the need for genetic counseling was high (96.1%). CONCLUSIONS: These results provide initial evidence of the efficacy of schizophrenia genetic counseling for families, even in the absence of individually relevant genetic test results or professional genetics services. The findings support the integration of contemporary genetic counseling for families into the general management of schizophrenia in the community.

Exercise trajectories of women from entry to a 6-month cardiac rehabilitation program to one year after discharge.

BACKGROUND: Physical activity is associated with reduced mortality and morbidity. Cardiac rehabilitation (CR) is an effective intervention for patients with cardiovascular disease (CVD). Unfortunately, women are less likely to engage in, or sustain, regular physical activity. Objectives were to (1) describe women's guidelines-based levels of physical activity during and after CR and (2) determine the physical activity trajectories of women from entry to CR to one year after CR. METHODS AND RESULTS: A prospective, longitudinal study of 203 women with CVD enrolled in a 6-month CR program. Physical activity was measured using the Godin Leisure Time Exercise Questionnaire (LSI), focusing on moderate-strenuous activity. Data were analyzed using latent class growth analysis (LCGA) and logistic regression. Mean scores on the LSI showed women to be "active" at all follow-up points. LCGA revealed a two-class model, respectively, called "inactive relapsers" and "moderately active relapsers." Predictors of the "moderately active relapsers" class were employment status and diagnosis of myocardial infarction. CONCLUSIONS: Women achieved the recommended physical activity levels by the end of CR and sustained them until one year after CR. LCGA allowed us to determine the class trajectories associated with moderate-strenuous activity and, from these, to identify implications for targeted intervention.

Exploring the influence of gender-role socialization and objectified body consciousness on body image disturbance in breast cancer survivors.

OBJECTIVE: This study aimed to explore the relationships between gender-role socialization, objectified body consciousness and quality of life in breast cancer (BC) survivors with body image (BI) disturbance post-treatment. METHODS: A total of 150 BC survivors participating in an ongoing randomized clinical trial of a group psychotherapy intervention for BI-related concerns completed a baseline battery of standardized measures including the following: Body Image Scale (BIS), Body Image after Breast Cancer Questionnaire (BIBCQ), Objectified Body Consciousness Scale (OBCS) measuring Body Shame and Surveillance, Gender-Role Socialization Scale (GRSS) measuring internalization of traditional gender roles and attitudes and the Functional Assessment of Cancer Therapy-Breast Quality-of-Life Instrument (FACT-B). Correlational analyses were conducted between the two BI questionnaires, the two primary psychosocial variables GRSS and OBCS, and FACT-B. Path analysis was conducted on a proposed theoretical model delineating pathways between the two primary psychosocial variables and BI disturbance. RESULTS: Significant positive correlations were found between the two BI scales and (a) GRSS (average r = 0.53, p < 0.000), (b) Body Shame (average r = 0.53, p < 0.000) and Surveillance (average r = 0.48, p < 0.000). The BIS and BIBCQ were negatively associated with the FACT-B (r = -0.62, -0.73, respectively; p < 0.000). Results from the path analysis demonstrated support for the proposed model. CONCLUSION: Breast cancer survivors who endorsed greater internalization of traditional gender roles and attitudes, who engaged in greater self-surveillance and experienced greater body shame, reported greater BI disturbance and poorer quality of life post-treatment. Women with these predispositions are likely to be more vulnerable for psychological distress and may experience poorer adjustment after BC treatment.

Mood and the menstrual cycle.

BACKGROUND: Premenstrual mood symptoms are considered common in women, but such prevailing attitudes are shaped by social expectations about gender, emotionality and hormonal influences. There are few prospective, community studies of women reporting mood data from all phases of the menstrual cycle (MC). We aimed (i) to analyze daily mood data over 6 months for MC phase cyclicity and (ii) to compare MC phase influences on a woman's daily mood with that attributable to key alternate explanatory variables (physical health, perceived stress and social support). METHOD: A random sample of Canadian women aged 18-40 years collected mood and health data daily over 6 months, using telemetry, producing 395 complete MCs for analysis. RESULTS: Only half the individual mood items showed any MC phase association; these links were either with the menses phase alone or the menses plus the premenstrual phase. With one exception, the association was not solely premenstrual. The menses-follicular-luteal MC division gave similar results. Less than 0.5% of the women's individual periodogram records for each mood item showed MC entrainment. Physical health, perceived stress and social support were much stronger predictors of mood (p < 0.0001 in each case) than MC phase. CONCLUSIONS: The results of this study do not support the widespread idea of specific premenstrual dysphoria in women. Daily physical health status, perceived stress and social support explain daily mood better than MC phase.

Cognitive factors affect treatment response to medical and psychological treatments in functional bowel disorders.

OBJECTIVES: For clinical trials in functional bowel disorders (FBD), the definition of a responder, one who meets the predefined criteria for a clinical response, is needed. Factors that determine clinical response aside from treatment itself are unknown. The aim of this study was to determine what baseline and post-treatment factors affect treatment response. METHODS: Females (n=397) with FBD entering a 12-week, four-arm, randomized NIH treatment trial (desipramine (DES), CBT, pill placebo, and education) were studied at baseline and after treatment. Demographic, clinical, psychosocial, and physiological variables were considered in the analysis. A responder was defined as a patient obtaining a score>3.5 on an averaged eight-item, five-point satisfaction-with-treatment questionnaire. Baseline and post-treatment logistic regressions were performed for each treatment condition to predict the responder outcome variable. RESULTS: Similar cognitive features predisposed participants to treatment response across the treatment conditions: sense of control over the condition, positive relationship with therapist or study coordinator, confidence in treatment, improvement in maladaptive cognitions, and quality of life during treatment. Demographic and clinical variables studied were not predictive. Some treatment-specific effects predicting responder status were noted, including a reduction in stool frequency with DES treatment and lack of abuse history in the placebo group. CONCLUSIONS: For medication, psychological, and placebo treatment in FBD, satisfaction with treatment depends on cognitive factors of confidence in treatments, perceived control over illness and symptoms, and reduction in negative cognitions related to symptom experience. Addressing these issues among patients with FBD may enhance treatment response to a variety of treatments.

Irritable bowel syndrome subtypes defined by Rome II and Rome III criteria are similar.

BACKGROUND: The implications of the Rome III recommendations to change the irritable bowel syndrome (IBS) subtype criteria for stool pattern are unknown. AIM: (1) Determine the level of agreement between Rome II and Rome III subtypes and (2) compare the behaviors of Rome II and Rome III subtypes over time. METHODS: Female patients (n=148) with Rome II defined IBS were prospectively tracked over 5 consecutive 3-month periods. At baseline, bowel habit reports on questionnaires were used to subclassify patients into Rome II and Rome III subtypes. Over the subsequent 15 months, bowel habit reports on diary cards were used to subclassify patients based on previously derived surrogate criteria into Rome II and Rome III IBS subtypes. RESULTS: The level of agreement between Rome II and Rome III subtype assignments was quite high (86.5%; kappa 0.79). The behavior of Rome II and Rome III subtypes over time was also similar in terms of subtype prevalence, subtype stability, and the proportion of subjects who met criteria for alternating irritable bowel syndrome. CONCLUSIONS: Rome II and Rome III IBS subtypes are in high agreement and behave similarly over time. Therefore, studies that used Rome II subtype criteria and studies that will use Rome III criteria will define comparable populations.

Not all side effects associated with tricyclic antidepressant therapy are true side effects.

BACKGROUND & AIMS: Patients with functional gastrointestinal disorders treated with tricyclic antidepressants sometimes report nongastrointestinal symptoms; it is unclear whether these are drug side effects or reflect a behavioral tendency to report symptoms. We evaluated whether symptoms reported before treatment with a tricyclic antidepressant (desipramine) increased in number or worsened in severity after 2 weeks of treatment and assessed the baseline factors that predispose patients to report symptoms. METHODS: Female patients in a multicenter National Institutes of Health trial for functional bowel disorders completed a 15-item symptom questionnaire at baseline (before randomization), 2 weeks after they were given desipramine (n = 81) or placebo (n = 40), and at study completion (12 weeks). Patients were asked about the severity and frequency of 15 symptoms. Results were analyzed from 57 patients given desipramine who completed the questionnaires. RESULTS: Symptoms reported as side effects to have occurred more frequently and also worsened at week 2 in the group given desipramine included dizziness, dry mouth/thirstiness, lightheadedness, jittery feelings/tremors, and flushing. Symptoms that did not change in severity or showed improvement at week 2 in the group given desipramine included morning tiredness, nausea, blurred vision, headaches, appetite reduction, and trouble sleeping. Psychologic distress but not desipramine blood level correlated with symptom reporting. CONCLUSIONS: Most symptoms often attributed to side effects of desipramine were present before treatment; only a few, related to anticholinergic effects, worsened 2 weeks after treatment, suggesting that most so-called side effects were not associated specifically with desipramine use. Such symptoms might instead be associated with psychologic distress.