Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation.

OBJECTIVES: To provide an accurate, web-based tool for stratifying patients with atrial fibrillation to facilitate decisions on the potential benefits/risks of anticoagulation, based on mortality, stroke and bleeding risks. DESIGN: The new tool was developed, using stepwise regression, for all and then applied to lower risk patients. C-statistics were compared with CHA2DS2-VASc using 30-fold cross-validation to control for overfitting. External validation was undertaken in an independent dataset, Outcome Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). PARTICIPANTS: Data from 39 898 patients enrolled in the prospective GARFIELD-AF registry provided the basis for deriving and validating an integrated risk tool to predict stroke risk, mortality and bleeding risk. RESULTS: The discriminatory value of the GARFIELD-AF risk model was superior to CHA2DS2-VASc for patients with or without anticoagulation. C-statistics (95% CI) for all-cause mortality, ischaemic stroke/systemic embolism and haemorrhagic stroke/major bleeding (treated patients) were: 0.77 (0.76 to 0.78), 0.69 (0.67 to 0.71) and 0.66 (0.62 to 0.69), respectively, for the GARFIELD-AF risk models, and 0.66 (0.64-0.67), 0.64 (0.61-0.66) and 0.64 (0.61-0.68), respectively, for CHA2DS2-VASc (or HAS-BLED for bleeding). In very low to low risk patients (CHA2DS2-VASc 0 or 1 (men) and 1 or 2 (women)), the CHA2DS2-VASc and HAS-BLED (for bleeding) scores offered weak discriminatory value for mortality, stroke/systemic embolism and major bleeding. C-statistics for the GARFIELD-AF risk tool were 0.69 (0.64 to 0.75), 0.65 (0.56 to 0.73) and 0.60 (0.47 to 0.73) for each end point, respectively, versus 0.50 (0.45 to 0.55), 0.59 (0.50 to 0.67) and 0.55 (0.53 to 0.56) for CHA2DS2-VASc (or HAS-BLED for bleeding). Upon validation in the ORBIT-AF population, C-statistics showed that the GARFIELD-AF risk tool was effective for predicting 1-year all-cause mortality using the full and simplified model for all-cause mortality: C-statistics 0.75 (0.73 to 0.77) and 0.75 (0.73 to 0.77), respectively, and for predicting for any stroke or systemic embolism over 1 year, C-statistics 0.68 (0.62 to 0.74). CONCLUSIONS: Performance of the GARFIELD-AF risk tool was superior to CHA2DS2-VASc in predicting stroke and mortality and superior to HAS-BLED for bleeding, overall and in lower risk patients. The GARFIELD-AF tool has the potential for incorporation in routine electronic systems, and for the first time, permits simultaneous evaluation of ischaemic stroke, mortality and bleeding risks. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF (NCT01090362) and for ORBIT-AF (NCT01165710)

Two-year outcomes of patients with newly diagnosed atrial fibrillation: results from GARFIELD-AF.

AIMS: The relationship between outcomes and time after diagnosis for patients with non-valvular atrial fibrillation (NVAF) is poorly defined, especially beyond the first year. METHODS AND RESULTS: GARFIELD-AF is an ongoing, global observational study of adults with newly diagnosed NVAF. Two-year outcomes of 17 162 patients prospectively enrolled in GARFIELD-AF were analysed in light of baseline characteristics, risk profiles for stroke/systemic embolism (SE), and antithrombotic therapy. The mean (standard deviation) age was 69.8 (11.4) years, 43.8% were women, and the mean CHA2DS2-VASc score was 3.3 (1.6); 60.8% of patients were prescribed anticoagulant therapy with/without antiplatelet (AP) therapy, 27.4% AP monotherapy, and 11.8% no antithrombotic therapy. At 2-year follow-up, all-cause mortality, stroke/SE, and major bleeding had occurred at a rate (95% confidence interval) of 3.83 (3.62; 4.05), 1.25 (1.13; 1.38), and 0.70 (0.62; 0.81) per 100 person-years, respectively. Rates for all three major events were highest during the first 4 months. Congestive heart failure, acute coronary syndromes, sudden/unwitnessed death, malignancy, respiratory failure, and infection/sepsis accounted for 65% of all known causes of death and strokes for <10%. Anticoagulant treatment was associated with a 35% lower risk of death. CONCLUSION: The most frequent of the three major outcome measures was death, whose most common causes are not known to be significantly influenced by anticoagulation. This suggests that a more comprehensive approach to the management of NVAF may be needed to improve outcome. This could include, in addition to anticoagulation, interventions targeting modifiable, cause-specific risk factors for death. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Blurred transitions of female genital cutting in a Norwegian Somali community.

While diaspora communities have become more critical of Female Genital Cutting (FGC), there are also trends of continuity. To explore the interplay between continuity and change, I designed a study among Somali migrants in Norway. A team of six Somali research assistants collected data from 72 male and female research participants between 16 and 57 years of age through in-depth interviews and focus group discussions. The aim of the study was to gather knowledge that could improve interventions among migrant populations. The study findings indicate that the experience of FGC as a practice in transition implies that people have to maneuver between different and partly contradictory social norms. The paper first discusses the contradiction between a strong negative attitude toward FGC and very low engagement. The lack of engagement is explained by the increased privatization of FGC and insecurities due to the transition and disempowerment with regard to challenging the FGC practices of relatives based in countries of origin. Second, the paper explores the contradiction between perceptions of FGC as a disappearing practice and the recognition of trends of continuation. Trends of continuation include those related to perceptions of risk during travel to countries of origin, resistance to defibulation, support for sunna circumcision and insecurities regarding the significance of FGC for marriageability. Thus, despite an almost universally negative attitude toward FGC in the form of infibulation, ongoing changes can, to some extent, hamper further change. This suggests that to ensure further progress in the abandonment of the practice, these complex and interconnected expectations must be addressed

Résistance à l’infibulation et à la désinfibulation. Changement des pratiques et persistance des valeurs en Norvège

L’« excision pharaonique », un type de mutilation génitale féminine créant une fermeture des parties génitales féminines, est associée à des valeurs culturelles essentiellement liées au genre et à la sexualité : la virginité et la vertu pour les femmes, le plaisir sexuel, la virilité, et la paternité pour les hommes. Afin que ces valeurs soient respectées, des infibulations doivent être opérées de bonne heure et conservées intactes jusqu’au mariage où elles doivent être partiellement ouvertes afin de permettre l’acte sexuel, puis encore davantage à l’accouchement. Les nombreuses complications liées à l’infibulation et à la douleur associée à la désinfibulation traditionnelle peuvent être considérablement réduites lorsqu’une désinfi-bulation chirurgicale est opérée, procédure par laquelle l’infibulation peut être dans une certaine mesure « décousue ». Cependant, alors que la désinfibulation chirurgicale a été largement mise à disposition en Norvège comme dans de nombreux pays d’immigration, son recours reste peu fréquent. Cet article explore les valeurs et les perceptions culturelles qui expliquent la résistance à cette opération.«Pharaonic circumcision», a type of female genital cutting creating a closure of the feminine genitalia, is associated with key cultural values related to gender and sexuality: virginity and virtue for women, and virility, sexual pleasure and paternity for men. To meet these values, infibulations must be performed at a young age and kept intact until marriage when they must be partially re-opened to enable sexual intercourse, and further opened at childbirth. Many complications that relate to infibulation and the pain associated with traditional defibulation can be significantly reduced by undergoing surgical defibulation, a procedure through which the infibulation to some extent can be undone. However, while surgical defibulation has been made widely available in Norway as in many other countries of immigration, the uptake is low. This paper explores some of the cultural values and perceptions that cause the resistance found to this surgery, and discusses how these perceptions can be overcome

Sexual norms and the intention to use healthcare services related to female genital cutting: A qualitative study among Somali and Sudanese women in Norway.

BACKGROUND:Female Genital Cutting (FGC) is a traditionally meaningful practice in Africa, the Middle East, and Asia. It is associated with a high risk of long-term physical and psychosexual health problems. Girls and women with FGC-related health problems need specialized healthcare services such as psychosexual counseling, deinfibulation, and clitoral reconstruction. Moreover, the need for psychosexual counseling increases in countries of immigration where FGC is not accepted and possibly stigmatized. In these countries, the practice loses its cultural meaning and girls and women with FGC are more likely to report psychosexual problems. In Norway, a country of immigration, psychosexual counseling is lacking. To decide whether to provide this and/or other services, it is important to explore the intention of the target population to use FGC-related healthcare services. That is as deinfibulation, an already available service, is underutilized. In this article, we explore whether girls and women with FGC intend to use FGC-related healthcare services, regardless of their availability in Norway. METHODS:We conducted 61 in-depth interviews with 26 Somali and Sudanese participants with FGC in Norway. We then validated our findings in three focus group discussions with additional 17 participants. FINDINGS:We found that most of our participants were positive towards psychosexual counseling and would use it if available. We also identified four cultural scenarios with different sets of sexual norms that centered on getting and/or staying married, and which largely influenced the participants' intention to use FGC-related services. These cultural scenarios are the virgin, the passive-, the conditioned active-, and the equal- sexual partner scenarios. Participants with negative attitudes towards the use of almost all of the FGC-related healthcare services were influenced by a set of norms pertaining to virginity and passive sexual behavior. In contrast, participants with positive attitudes towards the use of all of these same services were influenced by another set of norms pertaining to sexual and gender equality. On the other hand, participants with positive attitudes towards the use of services that can help to improve their marital sexual lives, yet negative towards the use of premarital services were influenced by a third set of norms that combined norms from the two aforementioned sets of norms. CONCLUSION:The intention to use FGC-related healthcare services varies between and within the different ethnic groups. Moreover, the same girl or woman can have different attitudes towards the use of the different FGC-related healthcare services or even towards the same services at the different stages of her life. These insights could prove valuable for Norwegian and other policy-makers and healthcare professionals during the planning and/or delivery of FGC-related healthcare services

“Damaged genitals”—Cut women's perceptions of the effect of female genital cutting on sexual function. A qualitative study from Sweden

Female genital cutting (FGC) is a traditional practice, commonly underpinned by cultural values regarding female sexuality, that involves the cutting of women's external genitalia, often entailing the removal of clitoral tissue and/or closing the vaginal orifice. As control of female sexual libido is a common rationale for FGC, international concern has been raised regarding its potential negative effect on female sexuality. Most studies attempting to measure the impact of FGC on women's sexual function are quantitative and employ predefined questionnaires such as the Female Sexual Function Index (FSFI). However, these have not been validated for cut women, or for all FGC-practicing countries or communities; nor do they capture cut women's perceptions and experiences of their sexuality. We propose that the subjective nature of sexuality calls for a qualitative approach in which cut women's own voices and reflections are investigated. In this paper, we seek to unravel how FGC-affected women themselves reflect upon and perceive the possible connection between FGC and their sexual function and intimate relationships. The study has a qualitative design and is based on 44 individual interviews with 25 women seeking clitoral reconstruction in Sweden. Its findings demonstrate that the women largely perceived the physical aspects of FGC, including the removal of clitoral tissue, to affect women's (including their own) sexual function negatively. They also recognized the psychological aspects of FGC as further challenging their sex lives and intimate relationships. The women desired acknowledgment of the physical consequences of FGC and of their sexual difficulties as “real” and not merely “psychological blocks”