Importance:Back pain is among the most common, disabling, and costly conditions managed in primary care in the US, but current treatment options often do not provide adequate relief. Mindfulness-based interventions have demonstrated effectiveness in individuals with chronic low back pain (CLBP); however, mindfulness remains underused in part because it is not integrated into most outpatient care models. Objective:To assess whether persons with CLBP participating in a mindfulness group medical visit intervention experience significantly improved pain intensity and interference compared with those receiving usual care. Design, Setting, and Participants:This randomized clinical trial, Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM), using a pragmatic approach (designed to evaluate interventions under typical conditions of care) was conducted from May 7, 2021, to November 6, 2024. Adults with CLBP attending primary care clinics in Massachusetts, Pennsylvania, and North Carolina were included. Intervention:Participants were randomized 1:1 to the OPTIMUM intervention, an 8-week telehealth-delivered mindfulness group medical visit program delivered as part of primary care (intervention), or usual care (controls). Main Outcomes and Measures:The primary analysis assessed the between-group difference in the primary outcome of change from baseline to month 6 in the Pain, Enjoyment of Life and General Activity (PEG) scale score. A mean minimal clinically important difference (MCID) in PEG score of at least 1 was considered. Secondary analyses evaluated the between-group differences in change from baseline to week 8 and month 12 in PEG score. Results:Of 451 participants (mean [SD], 52.1 [14.7] years; 318 [70.5%] female), 224 were randomized to the intervention group and 227 to the control group. All reported moderate pain interference at baseline. In intention-to-treat analyses, the intervention participants had a statistically significant improvement in PEG score from baseline compared with controls at the 6-month primary time point (mean change, -1.21 [95% CI, -1.50 to -0.92] vs -0.59 [95% CI, -0.86 to -0.31]; between-group difference, -0.62 [95% CI, -1.02 to -0.23]; P = .002) and at 8 weeks (mean change, -1.16 [95% CI, -1.44 to -0.88] vs -0.27 [95% CI, -0.53 to -0.003]; between-group difference, -0.89 [95% CI, -1.27 to -0.51]; P < .001) and 12 months (mean change, -1.52 [95% CI, -1.81 to -1.23] vs -0.78 [95% CI, -1.05 to -0.50]; between-group difference, -0.74 [95% CI, -1.14 to -0.34]; P < .001). The MCID was not met at any time point. Conclusions and Relevance:In this randomized clinical trial, a telehealth-delivered mindfulness group medical visit program for persons with CLBP resulted in significant improvements in pain intensity and interference compared with usual care; however, these changes did not meet the prespecified mean 1-point MCID between groups. The program incorporated primary care clinicians, was accessible, and is potentially scalable as a nonpharmacologic treatment for CLBP. Trial Registration:ClinicalTrials.gov Identifier: NCT04129450.
OBJECTIVES:Post-traumatic stress disorder (PTSD) is related to adverse mental and physical health outcomes and reduced wellbeing, yet limited work has examined associations between PTSD symptoms and sexual function among midlife women. We investigated whether PTSD symptoms were related to poorer sexual function among midlife women who reported past-month sexual activity (partnered or unpartnered). STUDY DESIGN:121 women aged 45-66 not taking hormone therapy self-reported PTSD symptom severity (PTSD Checklist-Civilian Version [DSM-IV]; yields a total score and symptom clusters: re-experiencing, avoidance/numbing, and hypervigilance), depressive symptoms (Center for Epidemiological Studies-Depression), alcohol use, medical history, and medication use; and completed physical measures (body mass index; BMI) and an actigraphy sleep protocol (total sleep time). Associations between PTSD symptom severity and sexual function were tested in linear regression models adjusted for age, race/ethnicity, education, partner status, vaginal estrogen use, alcohol use, years since final menstrual period, BMI, depressive symptoms, and total sleep time. Exploratory analyses examined associations between PTSD symptom clusters and sexual function. MAIN OUTCOME MEASURE:Past-month sexual function (score on the 6-item Female Sexual Function Index; lower scores = poorer function). RESULTS:The average score on the PTSD Checklist was 23.91 (6.81). Women with greater PTSD symptoms reported poorer sexual function [B(95% CI) = -6.52 (-10.86, -2.17), p = .004]. Considering PTSD symptom clusters, avoidance/numbing related to poorer sexual function [B(95% CI) = -3.69 (-6.90, -0.48), p = .025]. CONCLUSIONS:Overall PTSD symptom burden and avoidance symptoms were related to poorer sexual function. Results suggest the importance of assessing and addressing PTSD symptoms among midlife women to improve women's sexual health as they age.
BackgroundDiversity on biomedical research teams may lead to higher quality research, but some groups remain under-represented (UR) on research teams. Evaluating the challenges that UR scholars in the health sciences face could inform policies that institutions could take to recruit and retain UR scholars.ObjectiveWe used a large qualitative dataset to examine challenges in pursuing and persisting in research careers among UR postdoctoral and early-career faculty scholars participating in a randomized controlled trial.DesignWe conducted 78 individual qualitative interviews. Most participants held MDs or PhDs and were Black, Hispanic, or biracial. Interviews used a semi-structured guide and were audio-recorded and transcribed. A team of investigators developed an initial codebook based on a subset of interviews, which was iteratively revised by the team. After a final codebook was agreed upon, codes were assigned to all data. Codes were grouped into themes and sub-themes, which were discussed by the team. We present key themes and illustrative quotes.Key ResultsCareer challenges reported by UR scholars came from the culture of academia as well as from external factors. Academia culture challenges included demand for productivity and funding, bias and racism, competition and hierarchy, and the "secret rules" to the system. External challenges included financial stress, being an immigrant, and family demands. Responses to challenges could be positive, including making a career pivot, building resilience, finding one's community, or finding one's passion. Negative consequences to challenges included burnout, imposter syndrome, and low belongingness.ConclusionsChallenges faced by UR scholars can be both internal and external to the academy and can induce negative consequences among UR scholars, but some scholars also build resilience and find passion in the face of these challenges. Efforts to improve the culture of academia and to foster positive mentoring could help retain UR scholars in biomedical science.
Importance Back pain is among the most common, disabling, and costly conditions managed in primary care in the US, but current treatment options often do not provide adequate relief. Mindfulness-based interventions have demonstrated effectiveness in individuals with chronic low back pain (CLBP); however, mindfulness remains underused in part because it is not integrated into most outpatient care models. Objective To assess whether persons with CLBP participating in a mindfulness group medical visit intervention experience significantly improved pain intensity and interference compared with those receiving usual care. Design, Setting, and Participants This randomized clinical trial, Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM), using a pragmatic approach (designed to evaluate interventions under typical conditions of care) was conducted from May 7, 2021, to November 6, 2024. Adults with CLBP attending primary care clinics in Massachusetts, Pennsylvania, and North Carolina were included. Intervention Participants were randomized 1:1 to the OPTIMUM intervention, an 8-week telehealth-delivered mindfulness group medical visit program delivered as part of primary care (intervention), or usual care (controls). Main Outcomes and Measures The primary analysis assessed the between-group difference in the primary outcome of change from baseline to month 6 in the Pain, Enjoyment of Life and General Activity (PEG) scale score. A mean minimal clinically important difference (MCID) in PEG score of at least 1 was considered. Secondary analyses evaluated the between-group differences in change from baseline to week 8 and month 12 in PEG score. Results Of 451 participants (mean [SD], 52.1 [14.7] years; 318 [70.5%] female), 224 were randomized to the intervention group and 227 to the control group. All reported moderate pain interference at baseline. In intention-to-treat analyses, the intervention participants had a statistically significant improvement in PEG score from baseline compared with controls at the 6-month primary time point (mean change, −1.21 [95% CI, −1.50 to −0.92] vs −0.59 [95% CI, −0.86 to −0.31]; between-group difference, −0.62 [95% CI, −1.02 to −0.23]; P = .002) and at 8 weeks (mean change, −1.16 [95% CI, −1.44 to −0.88] vs −0.27 [95% CI, −0.53 to −0.003]; between-group difference, −0.89 [95% CI, −1.27 to −0.51]; P < .001) and 12 months (mean change, −1.52 [95% CI, −1.81 to −1.23] vs −0.78 [95% CI, −1.05 to −0.50]; between-group difference, –0.74 [95% CI, −1.14 to −0.34]; P < .001). The MCID was not met at any time point. Conclusions and Relevance In this randomized clinical trial, a telehealth-delivered mindfulness group medical visit program for persons with CLBP resulted in significant improvements in pain intensity and interference compared with usual care; however, these changes did not meet the prespecified mean 1-point MCID between groups. The program incorporated primary care clinicians, was accessible, and is potentially scalable as a nonpharmacologic treatment for CLBP. Trial Registration ClinicalTrials.gov Identifier: NCT04129450
Chronic low back pain is globally prevalent and associated with significant impairment in quality of life. Furthermore, people from historically marginalized communities are less likely to receive treatment, contributing to health inequities. Group mindfulness-based interventions improve pain and function, and virtual delivery has been demonstrated to be feasible. Little is known about how participants experience the virtual delivery of mindfulness-based interventions, especially participants from historically marginalized communities. This study explored participant perspectives of a virtual mindfulness-based group medical visit for people with chronic low back pain. Participants were recruited from the intervention arm of OPTIMUM, a study of virtual medical group visits using an adapted Mindfulness-Based Stress Reduction program for chronic low back pain. Semi-structured exit interviews were examined, and reflexive thematic analysis was used to compose key themes. Interviews from 59 participants (mean 56 years, 69.5% women; 45.8% Black or African American) were examined. Two major themes were derived from analysis. The first theme was 'effects of the external environment,' ie, the physical location from which the participant engaged with the session. The subthemes were comfort, social demands in the home setting, and sharing personal spaces. The second theme was 'navigating the virtual platform.' Subthemes were ease, struggle, and levels of support. Patient experiences varied substantially during the virtual mindfulness-based group medical visit intervention and this variation was influenced by social determinants of health. The key themes bring attention to the effects of the external environment and the technology itself on participation for people from historically marginalized communities. Basic tenets of mindfulness, such as present state awareness and equanimity, can provide a structure within which to navigate virtual participation amid home environments. Future studies are needed to explore differences in virtual and in-person mindfulness programs and to adapt virtual mindfulness programs. NCT04129450.
Low libido is a common and potentially distressing problem among midlife and older women. We recently reported results from a pilot randomized controlled trial of a mindfulness intervention for midlife and older cisgender women with low libido; the purpose of this qualitative investigation is to illustrate women’s experiences with being recruited for, enrolling in, and participating in the trial. We conducted individual interviews with a subset of trial participants, some of whom attended a group-based mindfulness intervention and some attended an educational control group (N = 25). We also interviewed participants who were enrolled but did not attend any groups (N = 9). A semi-structured interview guide was developed by the study team. A co-investigator with qualitative research expertise and the primary investigator conducted interviews, which were audio recorded and transcribed. We used a thematic analysis approach to analysis, co-coding a subset of interviews to develop and refine a codebook, then assigning codes to all data. Codes were grouped into subthemes and themes and key insights were extracted. Three key themes emerged from women who attended groups. First, women were interested in the intersection of sexuality and mindfulness. Second, women in both groups valued the sense of community they gained from participating; the interactive nature of sessions contributed to this. Third, experiences with attending groups over videoconferencing software were largely positive. Suggestions for improvement included a better explanation of the randomization process and more didactic information about sexuality and aging in both groups. Non-attendees listed time conflicts as their top reason for not attending. We recommend researchers consider utilizing a group format when designing behavioral interventions for midlife and older women, as this design offers many benefits for participants, but ensuring that a qualified professional is present can ensure information exchanges is evidence-based. In addition, healthcare systems can consider building in opportunities for midlife women to gather and exchange information regarding health.
BACKGROUND:Chronic low back pain (cLBP) is extremely common and is one of the Chronic Overlapping Pain Conditions (COPCs), 10 conditions thought to have similar underlying pathophysiology. Little is known about the prevalence and co-occurrence of cLBP with other commonly accepted conditions referred to as COPCs. METHODS:We assessed participants enrolled in a pragmatic trial of mindfulness-based stress reduction for cLBP to determine the prevalence of co-occurring COPCs using a validated COPC screener. We compared psychosocial and physical functioning among participants with only cLBP and participants with cLBP and additional COPCs using Student's t-tests, chi-squared tests and multivariable linear regression. RESULTS:Among 285 enrollees (age range: 18-88 years, mean age: 52.2 years, SD = 15.3), 272 (95%) reported pain outside the upper and lower back region. One hundred and twenty-nine people (45%) had one COPC, and 68 (24%) had two or more COPCs not including cLBP. The most common COPCs were irritable bowel syndrome (n = 56, 20%); myalgia encephalomyelitis/chronic fatigue syndrome (n = 54, 19%); and fibromyalgia (n = 42, 15%). CONCLUSION:We found strong differences when comparing people with cLBP alone to those with cLBP and COPCs. People with COPCs reported more pain symptoms, higher levels of anxiety, depression, fatigue and scored worse across measures of physical functioning and pain symptoms. An additional COPC was associated with a 7.6-point increase in fatigue scores (95% CI: 5.6, 9.7) on a T-score metric (mean = 50, SD = 10). SIGNIFICANCE STATEMENT:Compared to people with low back pain alone, individuals with additional chronic pain experienced more severe pain symptoms, more anxiety, depression and fatigue. In this sample of people with cLBP, overlapping pain conditions were common, affecting 45% of people. REGISTRATION NUMBER AND REGISTRY NAME:Clinicaltrials.gov identifier NCT04129450.
The OPTIMUM trial is a multisite pragmatic randomized clinical trial of an adapted Mindfulness Based Stress Reduction (MBSR) program for people with chronic low back pain in primary care settings provided via telehealth group medical visits. Researchers conducted fifty-nine exit interviews at the end of the intervention to inform the ongoing conduct of the trial and to better understand patients’ experiences. This manuscript describes a pragmatic approach to the qualitative analysis of exit interviews within a pragmatic clinical trial. The analysis included three important pivots. First, researchers conducted a process evaluation using a rapid approach called the Lightning Report method. Second, team-based approaches to qualitative analysis were utilized to pair experienced and inexperienced qualitative researchers. Third, based upon principles from Big Qual methodology, a codebook was developed and applied to provide an aerial overview of the data in preparation for more in-depth exploration. Based upon these pivots, the process evaluation provided actionable results in a timely fashion, team members increased analytical skills, and multiple analyses are being applied to the data set. By describing the pragmatic decisions to pivot approaches to qualitative analysis, this manuscript contributes to existing literature regarding rapid qualitative analysis methods for process evaluation in pragmatic clinical trials, team-based mentorship in large trials, and applications from Big Qual for large data sets.
Midlife for women includes the menopause transition. Menopause can be accompanied by substantial symptoms, disruptions and health changes that can require specialized attention and intervention. However, midlife can be a time of psychological growth and well-being for women. A growing body of research underscores the complex interrelationships between mental health and well-being and menopausal symptoms such as vasomotor symptoms, sleep disturbances, problems with sexual function and cognitive symptoms. Similarly, an increasing number of behavioural interventions have become available that can help to manage symptom occurrence and enhance mental health. In this Review, we approach midlife and menopause as both a biological and a psychological transition. We summarize the changes in reproductive hormones and cessation of menstrual cycles that characterize menopause stages and detail the connections between the biological and psychological changes and symptoms that are common during these stages. We complement this information by discussing behavioural approaches that can help to manage menopausal symptoms and related mental health concerns. On the basis of this integrative approach, we finalize the Review with recommendations for research directions to optimize women’s health and functioning at midlife and beyond. There are complex interactions between physical changes during the menopause transition and mental health and wellbeing. In this Review, Thurston et al. integrate these interactions and outline behavioural approaches to managing menopausal symptoms and related mental health concerns.
Menopause is a natural and universal experience that causes disruptive symptoms that adversely affect work experiences for many women. This consensus recommendation summarizes existing literature and provides recommendations for women, employers, and the healthcare professionals caring for people with menopause symptoms; however, there remains a significant need for additional research on effective workplace interventions, not only to help retain women in the workforce, but also to ensure that they are supported and can thrive. Menopause is a natural life transition experienced by half the world's population. Women aged 50 years and older are the fastest growing demographic group in many countries, making essential contributions to the workforce. Although menopause is a universal and natural life transition, the symptom experience is highly variable among women. Some women may experience few or no symptoms, whereas others may be bothered by moderate to severe symptoms for a decade or longer, which can adversely affect quality of life, relationships, job satisfaction, and career advancement. Indeed, menopause symptoms, including vasomotor and genitourinary symptoms, as well as sleep and mood disturbances are associated with multiple adverse work outcomes. Studies to date have demonstrated that these adverse work outcomes related to menopause symptoms include a compromised ability to work, reduced work productivity, absenteeism, and even loss of employment or an early exit from the workforce. Further, the relationship between menopause symptoms and work may be bidirectional, with certain aspects of the work environment being linked with a greater menopause symptom burden, such as insufficient restroom facilities, unpredictable or long work hours, the inability to take breaks, and confined or crowded workspaces. Thus, workplace solutions may need to be tailored based on women's individual needs, the work environment, and the type of work.The Menopause Society, in conjunction with an expert panel of medical and legal experts and women's health advocates, has developed a set of consensus recommendations that challenges employers to create a menopause-supportive workplace for their employees. These recommendations include, among other things, suggestions for employers to review policies and healthcare plans and benefits and to consider flexibility and accommodations that may be needed for some women with menopause symptoms. Guidance for women with menopause symptoms that affect them at work in terms of understanding their resources and empowering them to be self-advocates are also provided, as well as recommendations for what occupational health professionals should know and do for women with bothersome menopause symptoms in the workplace.
Objectives: This study's aim is to examine patterns of menopause symptoms and attitudes among United States women from different religious affiliations. Study design: We used data from a national sample of midlife and older adults. For this analysis, we included only women who were postmenopausal or had undergone hysterectomy. We constructed univariate and multivariate logistic regression models to examine the relationship between religious affiliation and menopause symptoms and attitudes while adjusting for potential confounders. Main outcome measures: Menopause symptoms (hot flashes, pain in sexual interactions, pleasure in sexual interactions, trouble falling asleep) and attitudes (relief on periods stopping, regret on periods stopping, worry about becoming less attractive) measured by self-report on Likert scales. Results: Across denominations, 47 % of women experienced hot flashes, 48 % experienced pain in sexual interactions, 95 % experienced pleasure, and 88 % had trouble falling asleep. Regarding attitudes towards menopause and aging, 62 % felt relief in their periods stopping, while 56 % expressed worry about becoming less attractive with aging. Baptist women were more likely to experience hot flashes and trouble falling asleep compared to Catholic women. However, when adjusted for smoking status, this relationship did not persist. Unaffiliated and Spiritual women were less likely to experience trouble falling asleep and more likely to report pleasure in sexual interactions compared to Catholic women. Spiritual women were significantly more likely to feel regret on periods stopping compared to Catholics. Conclusions: There is a relationship between religious affiliation and the menopause experience. These findings demonstrate the importance of considering social influences on women's health.
A satisfying sex life is a key component of health and well-being for many older women. However, there is insufficient awareness of and care for women’s sexual health. This Comment discusses steps healthcare providers can take to support women’s sexual health across the lifespan, which should be a top priority.
Background:Mindfulness research and clinical programs are widespread, and it is important that mindfulness-based interventions are delivered with fidelity, or as intended, across settings. The MBI:TAC is a comprehensive system for assessing teacher competence, yet it can be complex to implement. A standardized, simple fidelity/engagement tool to address treatment delivery is needed. Objective:We describe the development, evaluation, and outcomes of a brief, practical tool for assessing fidelity and engagement in online mindfulness-based programs. The tool contains questions about session elements such as meditation guidance and group discussion, and questions about participant engagement and technology-based barriers to engagement. Methods:The fidelity rating tool was developed and tested in OPTIMUM, Optimizing Pain Treatment in Medical settings Using Mindfulness. The OPTIMUM study is a 3-site pragmatic randomized trial of group medical visits and adapted mindfulness-based stress reduction for primary care patients with chronic low back pain, delivered online. Two trained study personnel independently rated 26 recorded OPTIMUM sessions to determine inter-rater reliability of the Concise Fidelity for Mindfulness-Based Interventions (CoFi-MBI) tool. Trained raters also completed the CoFi-MBI for 105 sessions. Raters provided qualitative data via optional open text fields within the tool. Results:Inter-rater agreement was 77-100% for presence of key session components, and 69-88% for Likert ratings of participant engagement and challenges related to technology, with discrepancies only occurring within 2 categories: 'very much' and 'quite a bit'. Key session components occurred as intended in 94-100% of the 105 sessions, and participant engagement was rated as 'very much' or 'quite a bit' in 95% of the sessions. Qualitative analysis of rater comments revealed themes related to engagement challenges and technology failures. Conclusion:The CoFi-MBI provides a practical way to assess basic adherence to online delivery of mindfulness session elements, participant engagement, and extent of technology obstacles. Optional text can guide strategies to improve engagement and reduce technology barriers.
This is the first study to examine the perimenopausal experiences of women with cystic fibrosis (CF) in the era of modulator therapy. As the life expectancy of people with CF continues to grow, CF care teams need to be able to address the perimenopausal needs of their female patients as well as the interactions between the menopausal transition and CF. Abstract Objective This study aimed to describe the menopause experience of people with cystic fibrosis (CF). Methods We conducted a computer-based cross-sectional survey of women with CF 25 years or older at 10 US CF centers exploring a range of sexual and reproductive health concerns, including menopause. We used descriptive statistics to analyze results. Results Of 460 participants, 5 (3%) were perimenopausal and 34 (7%) were postmenopausal. Of participants perimenopausal or menopausal (n = 39), 97% reported the following menopausal symptoms occurring at least once a week: most commonly early wake-up (83%); stiffness/soreness in joints, neck, or shoulders (65%); and night sweats (65%). Among menopausal participants, the median self-reported age at menopause was 48.5 years (interquartile range, 5.5 y). Thirty percent experienced worsened CF symptoms during menopause, and 42% experienced worsening CF symptoms after menopause. Twenty-four percent of menopausal participants were on estrogen therapy and 15% on estrogen and progesterone therapy. Three-fourths of participants using hormone therapy reported no change in their CF symptoms. One percent of the 460 survey participants reported discussing menopause with their CF provider, despite 19% wanting to discuss this topic with their CF team. Conclusions This is the first study to describe menopause symptoms of people with CF. People with CF experience a variety of menopausal symptoms and often report a worsening of their CF symptoms after menopause, suggesting an interplay between female sex hormones and CF. Larger studies are needed comparing the sexual and reproductive health experiences and care needs of people with CF in the menopause transition to the general population.
BACKGROUND:Distressing low libido is common among women and has significant negative impacts; mindfulness has shown promise to increase sexual desire in women with low libido, but existing interventions are not tailored to midlife and older women. AIM:We adapted a mindfulness intervention to meet the needs of this population and conducted a pilot randomized controlled trial to assess feasibility and acceptability. METHODS:Women aged ≥45 years with low libido were randomized to the mindfulness intervention or an education group that met over videoconferencing. The intervention included mindfulness instruction and practice, group discussion, and education on sexuality and aging. The education group included general information on menopause and health. OUTCOMES:We defined feasibility by the number of screened women who enrolled and completed their group. We defined acceptability as satisfaction with the group and likelihood of recommending it to another woman with low libido. We assessed sexual function (Female Sexual Function Index) and sexual distress (Female Sexual Distress Scale-Revised) at 6 weeks postconclusion. RESULTS:Of 81 women screened, 31 were randomized to mindfulness and 30 to education. Eighteen women in the intervention group and 23 in the control group attended at least 1 session. Time conflict was the main reason for nonattendance. Of the 41 women who started attending groups, 37 (90%) attended at least 5 sessions. In the mindfulness group, 73% of women were very or extremely satisfied. Women in the mindfulness group were more likely to recommend it to another person with low libido as compared with those in the education group (P = .031); 67% said that they would probably or definitely recommend it. There were no significant changes in sexual function in either group (mean Female Sexual Function Index score, 22.6 to 18.6 [P = .101] with mindfulness and 21.2 to 19.7 [P = .537] with education). Women in the mindfulness group had significant improvements in sexual distress (mean Female Sexual Distress Scale-Revised score, 27.1 to 19.7; P = .021) while women in the education group did not (19.0 to 15.8; P = .062). CLINICAL IMPLICATIONS:Mindfulness may reduce sexual distress in older women with low libido. STRENGTHS AND LIMITATIONS:This is the first trial testing mindfulness for midlife and older women with low libido. CONCLUSION:A virtual mindfulness intervention for midlife and older women with low libido is feasible and acceptable and appears to improve sexual distress as compared with an education control; these findings provide data that can be used to design a larger clinical trial.