Illness perceptions and health-related quality of life in individuals with overweight and obesity.

INTRODUCTION: To understand how individuals (self-)manage obesity, insight is needed into how patients perceive their condition and how this perception translates into health outcomes (e.g., health-related quality of life, HRQOL). Our objectives were (1) to examine illness perceptions in individuals with overweight and obesity, and (2) to investigate associations of these perceptions with physical and mental HRQOL. METHODS: In a cross-sectional analysis of the Netherlands Epidemiology of Obesity Study (n = 6432; 52% women), illness perceptions were assessed using the Brief Illness Perception Questionnaire, and HRQOL was assessed using the 36-Item Short-Form Health Survey. Illness perceptions were calculated for different categories of overall, abdominal, and metabolically unhealthy obesity. We investigated associations of illness perceptions with HRQOL using BMI-stratified multivariable linear regression analyses. RESULTS: Compared to individuals with normal weight, individuals with obesity believed to a higher extent that their condition had more serious consequences [Mean Difference (95%CI): 1.8 (1.6-2.0)], persisted for a longer time [3.4 (3.2-3.6)], manifested in more symptoms [3.8 (3.6-4.0)], caused more worry [4.2 (3.9-4.4)] and emotional distress [2.0 (1.8-2.2)], but was more manageable with medical treatment [3.1 (2.9-3.4)]. They perceived to a lesser extent that they had personal control [-2.2 (-2.4, -2.0)] and understanding [-0.3 (-0.5, -0.1)] regarding their condition. These negative perceptions were less pronounced in individuals with abdominal obesity. Behaviour/Lifestyle was attributed by 73% of participants to be the cause of their obesity. Stronger negative illness perceptions were associated with impaired HRQOL, particularly the physical component. CONCLUSION: Individuals with obesity perceived their conditions as threatening, and this seemed somewhat stronger in individuals with overall obesity than those with abdominal obesity. Behaviour/Lifestyle is a crucial target intervention and empowering self-management behaviour to achieve a healthy body weight may deliver promising results. In addition, strategies that aim to change negative perceptions of obesity into more adaptive ones may improve HRQOL.

Psychosocial determinants of adherence with oral anticancer treatment: 'we don't need no education'.

INTRODUCTION: Given the potentially fatal consequences of inadequate adherence with oral anticancer treatment in persons with cancer, understanding the determinants of adherence is vital. This paper aims at identifying psychosocial determinants of adherence to oral anticancer treatment. METHODS: We reviewed the literature on psychosocial determinants of adherence with oral anticancer treatment, based on published literature in English, from 2015 to present. Literature searches were performed in PubMed, Embase, Web of Science, Cochrane library, Emcare, and PsychINFO, with 'cancer', 'medication adherence', 'psychology', and 'oral anticancer treatment' as search terms. The obtained 608 papers were screened by two independent reviewers. RESULTS: In the 25 studies identified, illness perceptions, medication beliefs, health beliefs, and depression were found to be the major psychosocial determinants of adherence to oral anticancer treatment; sociodemographic and clinical characteristics were found to be of no major importance. The quality of the identified studies as assessed by two independent reviewers was found to be acceptable overall. The majority of papers were from North America and focused on patients with breast cancer; sample size varied from 13 to 1371; adherence was assessed with questionnaires derived from various theoretical models, pill counts and electronic pharmacy records; illness perceptions reflecting adaptive coping, and medication beliefs reflecting high necessity and low concerns were found to be associated with adherence. CONCLUSION: Psychosocial concepts are major determinants of adherence with oral anticancer treatment. 'Beliefs about medicines' and 'illness perceptions' in particular determine adherence with this treatment. Studies aiming at impacting adherence would benefit from interventions with a solid basis in behavioral theory in order to help health care providers explore and address illness perceptions and medication beliefs. Pre-consultation screening of adherence behavior may be a helpful supportive approach to improve adherence. Blaming the victim ('patients should be educated about the importance of adherence') is better replaced by encouraging health professionals to identify and address maladaptive psychosocial determinants of adherence.

Illness perceptions are associated with higher health care use in survivors of endometrial cancer-a study from the population-based PROFILES registry.

OBJECTIVES: According to the Common Sense Model of self-regulation, cancer survivors construct perceptions of their illness as a (mal)adaptive mechanism. These perceptions might impact on health care use. We aimed to explore the association between illness perceptions and health care use in stage I-II endometrial cancer (EC) survivors, and whether these associations differed by time since diagnosis. METHODS: A survey was conducted in 2008 by the population-based PROFILES registry among EC survivors diagnosed between 1999 and 2007. Survivors (n = 742, 77% response) completed the Brief Illness Perception Questionnaire (BIPQ) and questions on health care use in the past 12 months. Clinical data were accessed from the Netherlands Cancer Registry. Multiple logistic regression was used to evaluate the relationship between illness perceptions and health care use. RESULTS: Between 15 and 22% of the survivors had negative illness perceptions. Survivors with more negative perceptions on consequences, timeline, treatment control, identity, cognitive representation, concern, emotion, and emotional representation were more likely to make ≥ 1 visit to their family physician/general practitioner in relation to their cancer when compared with survivors with more positive illness perceptions. More negative perceptions on consequences, timeline, identity, and concern were associated with ≥ 2 general or cancer-related visits to the medical specialists. The association between negative illness perceptions and health care use was more prominent among long-term (>5 years post-diagnosis) EC survivors. CONCLUSIONS: Negative illness perceptions among EC survivors were associated with higher health care use. For individuals with maladaptive illness perceptions, visits to their health care provider may reduce worry about their illness. Future research might address the effects of intervening in maladaptive illness perceptions on use of health care in this category of survivors.

Maternal acceptability of pulse oximetry screening at home after home birth or very early discharge.

The Netherlands has a unique perinatal healthcare system with a high rate of home births and very early discharge after delivery in hospital. Although we demonstrated that pulse oximetry (PO) screening for critical congenital heart disease is feasible in the Netherlands, it is unknown whether parents find the screening acceptable when performed in home birth setting. We assessed the acceptability of PO screening to mothers after screening in home setting. A questionnaire was sent electronically to mothers who gave birth and/or had postnatal care under supervision of a community midwife participating in the Pulse Oximetry Leiden Screening (POLS) study, a feasibility study of PO screening in the Dutch care system, performed in the Leiden region, the Netherlands. The questionnaire included questions based on satisfaction, general feelings, and perceptions of PO screening. A total of 1172/1521 (77%) mothers completed the questionnaire. Overall, mothers were happy with the performance of the test (95%), thought their baby was comfortable during the screening (90%) and did not feel stressed while the screening was performed (92%). Most mothers would recommend the test to others (93%) and considered the test important for all babies (93%). CONCLUSION: Mothers of newborns participating in the study found the PO screening acceptable when performed at home. What is Known: • Pulse oximetry screening for critical congenital heart defects is (cost)effective and acceptable to mothers when performed in hospital. What is New: • Pulse oximetry screening for critical congenital heart defects is also acceptable for mothers when the screening is performed at home.

Coping styles and disability in patients with hand osteoarthritis.

OBJECTIVE: Coping responses have been shown to determine health outcomes in chronic diseases. The aim of the study was to examine the role of joint-specific factors and coping styles on disability in patients with hand OA. METHODS: Primary hand OA patients who consulted secondary care, underwent physical examination to assess the number of joints with bony joint enlargements, pain upon palpation, soft tissue swelling, deformities and limitations in motion. Coping styles were assessed with Coping with Rheumatic Stressors. Disability (score ≥5) was assessed by the Functional Index for Hand OA (possible score 0-30) cross-sectionally and after 1 year. With multivariate logistic regression, joint-specific variables and coping styles were associated with disability cross-sectionally and after 1 year, adjusted for age, sex and BMI. RESULTS: A total of 314 patients (88% women, mean age 61.4 years) were included in the cross-sectional analyses; 68% were considered as disabled. Longitudinal data after 1 year were available in 173 patients (71% disabled). In multivariate analysis including all joint-specific factors, only painful joints and joints with limitations in motion were associated with disability. Disadvantageous scores for the coping scales (comforting cognitions, decreasing activity and pacing) were positively associated with disability cross-sectionally. Disability after 1 year was only associated with the coping scales decreasing activity and pacing. Joint-specific factors were also associated with disability, independent of coping styles. CONCLUSION: In patients with hand OA, joint-specific factors and coping styles decreasing activity and pacing were both associated with disability. Our results suggest that interventions should aim at joint-specific complaints as well as changing coping styles to improve functional outcome.

Is the MARS questionnaire a reliable measure of medication adherence in childhood asthma?

OBJECTIVE: To assess the reliability of the Medication Adherence Report Scale (MARS-5) for assessing adherence in clinical practice and research. METHODS: Prospective cohort study following electronically measured inhaled corticosteroids (ICS) adherence for 1 year in 2-13-year-old children with persistent asthma. The relationship between electronically measured adherence and MARS-5 scores (ranging from 5 to 25) was assessed by Spearman's rank correlation coefficient. A ROC (receiver operating characteristic) curve was performed testing MARS-5 against electronically measured adherence. Sensitivity, specificity, positive and negative likelihood ratios of the closest MARS-5 cut-off values to the top left-hand corner of the ROC curve were calculated. RESULTS: High MARS scores were obtained (median 24, interquartile range 22-24). Despite a statistically significant correlation between MARS-5 and electronically assessed adherence (Spearman's rho = 0.47; p < 0.0001), there was considerable variation of adherence rates at every MARS-5 score. The area under the ROC curve was 0.7188. A MARS-5 score ≥23 had the best predictive ability for electronically assessed adherence, but positive and negative likelihood ratios were too small to be useful (1.65 and 0.27, respectively). CONCLUSIONS: Self-report using MARS-5 is too inaccurate to be a useful measure of adherence in children with asthma, both in clinical practice and in research.

Xerosis and pruritus as major EGFRI-associated adverse events.

PURPOSE: The objective of this sub-analysis of the BeCet study (NCT01136005) was to examine health-related quality of life (HRQoL) of patients experiencing dermatological adverse events (AEs) during the first 6 weeks of epidermal growth factor receptor inhibitor (EGFRI) treatment. METHODS: Patients (n = 85) treated with EGFRI completed five questionnaires during the first 6 weeks of treatment. 77 patients provided enough data for the sub-analysis. Experienced AEs were reported in the Dermatological Reactions Targeted Therapy-Patients (DERETT-P), a symptom experience diary for patients treated with targeted therapy. The impact of EGFRI-associated dermatological adverse events on HRQoL was examined using four HRQoL questionnaires; the Functional Assessment of Cancer Therapy-EGFRI (FACT-EGFRI-18), the Functional Assessment of Cancer Therapy-General (FACT-G), the 36-Item Short Form Health Survey (SF-36), and the Skindex-16. RESULTS: During the first 6 weeks of EGFRI treatment, physical discomfort was the most significantly affected domain. In the entire study population, xerosis (dry skin) (22.3 %) and pruritus (itchy skin) (16.9 %) were reported as the most impactful AEs. For patients experiencing a papulopustular eruption (acneiform rash) pruritus (24.2 %), xerosis (18.9 %), and papulopustular eruption (6.3 %) were reported as the most impactful AEs. Papulopustular eruption, xerosis, and pruritus all showed a significant negative effect on HRQoL, displayed in FACT-EGFRI-18 scores. CONCLUSIONS: In addition to papulopustular eruption, xerosis and pruritus are major EGFRI-associated dermatological AEs with an impact on HRQoL, which warrant more attention in clinical practice and research.

Non-adherence in children with asthma reviewed: The need for improvement of asthma care and medical education.

Adherence to daily inhaled corticosteroid therapy is a key determinant of asthma control. Therefore, improving adherence to inhaled corticosteroids is the most effective method through which healthcare providers can help children with uncontrolled asthma. However, identifying non-adherent patients is difficult, and electronic monitoring is the only reliable method to assess adherence. (Non-)adherence is a complex behavioural process influenced by many interacting factors. Intentional barriers to adherence are common; driven by illness perceptions and medication beliefs, patients and parents deliberately choose not to follow the doctor's recommendations. Common non-intentional barriers are related to family routines, child-raising issues, and to social issues such as poverty. Effective interventions improving adherence are complex, because they take intentional and non-intentional barriers to adherence into account. There is evidence that comprehensive, guideline-based asthma self-management programmes can be successful, with excellent adherence and good asthma control. Patient-centred care focused on healthcare provider-patient/parent collaboration is the key factor determining the success of guided self-management programmes. Such care should focus on shared decision-making as this has been shown to improve adherence and healthcare outcomes. Current asthma care falls short because many physicians fail to adhere to asthma guidelines in their diagnostic approach and therapeutic prescriptions, and because of the lack of application of patient-centred health care. Increased awareness of the importance of patient-centred communication and increased training in patient-centred communication skills of undergraduates and experienced attending physicians are needed to improve adherence to daily controller therapy and asthma control in children with asthma.

Stick Together: A Nordic Walking Group Intervention for Breast Cancer Survivors.

Axillary lymph node dissection and axillary radiation as part of breast cancer treatment often result in arm and shoulder morbidity and limitations in daily functioning. Over and above the general benefits for cardiorespiratory fitness, Nordic Walking particularly targets at the muscles of the upper extremities and shoulder. This may increase shoulder range of motion and lead to a reduction in functional limitations. The aim of this study was to offer a Nordic Walking intervention to women after treatment for breast cancer and to investigate changes in subjective well-being and shoulder function. Three supervised Nordic Walking courses were organized (2009-2011). The intervention consisted of ten weekly 1-hour sessions focusing on upper body strength and condition. In total, 28 women participated in one of the cohorts. Results showed that after 10 weeks, patients' vitality had improved, whereas perceived shoulder symptom severity and limitations in daily activities had decreased. Goniometric data indicated that range of motion (forward flexion, abduction, and external rotation) of the affected shoulder improved significantly within 10 weeks of training. Group interviews at 6 months follow-up confirmed that patients had appreciated the physical and psychosocial benefits of the intervention. These benefits outweighed the practical disadvantages. Patient selection, assessment and training should take place under (para-)medical supervision and group instructors should have the knowledge and skills to work with a group of recent cancer survivors. Results from this explorative study suggest that Nordic Walking is a feasible and potentially valuable tool in the rehabilitation of patients with breast cancer.

It's the adherence, stupid (that determines asthma control in preschool children)!

Although guideline-based asthma care and adherence to inhaled corticosteroids are predictors of asthma control, the role of adherence in maintaining long-term asthma control is largely unknown. This study was designed to explore the relationship between adherence to inhaled corticosteroids and long-term asthma control in young children with asthma. In this observational study, 81 2-6-year-old asthmatic children, using inhaled corticosteroids, closely followed-up in a programme with extensive self-management training, were enrolled. Adherence was measured daily for 12 months using Smartinhaler (Nexus6 Ltd, Auckland, New Zealand) devices. Long-term asthma control was assessed by parents and physicians and included clinical assessment, an asthma control questionnaire and lung function measurement. We examined the association of adherence to asthma control, adjusting for seasonal influences and clinical characteristics. Median (interquartile range) adherence was 87% (70-94%), and 64 (79%) children had well-controlled asthma throughout follow-up. Adherence >80% was associated with better asthma control, and we found no important confounders of this association. Children with persistent mild symptoms had lower adherence rates (p=0.028). Guideline-based asthma care was associated with good asthma control in most children. Adherence to inhaled corticosteroids was an independent strong predictor of long-term asthma control, with highest levels of asthma control found in children with adherence >80% of doses prescribed.

Every parent tells a story: why non-adherence may persist in children receiving guideline-based comprehensive asthma care.

OBJECTIVE: Effective self-management and adherence to inhaled corticosteroids are issues of particular interest in comprehensive asthma care. In spite of this care, however, a number of parents and children remain non-adherent. The reasons for this non-adherence have up till now been unknown, because previous adherence studies have based their findings either on populations with poor adherence or on unreliable self-reported adherence. This study was designed to explore factors that contribute to persistent non-adherence to inhaled corticosteroids in children ranging between 2 and 12 years of age receiving comprehensive asthma care, with adherence assessed objectively. METHODS: This qualitative study was based on in-depth interviews which took place in the homes of parents whose children had completed a one-year follow-up of electronically measured adherence to inhaled corticosteroids. Rich and comprehensive descriptions of parents' own accounts of self-management behavior were obtained using active listening techniques. Each interview was recorded and transcribed verbatim followed by data analysis using standard methodology for qualitative studies. RESULTS: Twenty children's parents (mean age 5.9 years) were interviewed. Distinctive patterns of modifiable barriers to adherence emerged, including a novel finding of parents misjudging their child's ability to manage the daily use of medication by him/herself. Persistent non-adherence appeared to be caused by a number of maintaining factors. Most noticeable factors were unawareness of non-adherence by both parents and health care providers, a lack of parental drive to achieve high adherence and ineffective parental problem-solving behaviour. CONCLUSIONS: This study has identified modifiable barriers to adherence in families participating in a comprehensive asthma care programme. Future studies are needed to verify our novel findings and to investigate whether interventions around these barriers are needed to increase the effectiveness of asthma care programs.

Illness perceptions in cancer survivors: what is the role of information provision?

BACKGROUND: The aim of this study was to provide insight into the relationship between information provision and illness perceptions among cancer survivors. METHODS: All individuals diagnosed with lymphoma, multiple myeloma, endometrial or colorectal cancer between 1998 and 2008, as registered in the Eindhoven Cancer Registry, were eligible for participation. In total, 4446 survivors received a questionnaire including the EORTC-QLQ-INFO25 and the Brief Illness Perception Questionnaire; 69% responded (n = 3080). RESULTS: Lymphoma and multiple myeloma patients were most satisfied with the information they received, and they perceived to having received more information about their treatment and other services (after care) compared with colorectal and endometrial cancer survivors (p < 0.05). Multiple myeloma patients reported the highest scores (conceptualized their illness as very serious) on the illness perception scales. The perceived receipt of more disease-specific information was associated with more personal and treatment control and a better understanding of the illness, whereas the perceived receipt of more information about other services was associated with more negative consequences of the illness on the patients' life, longer perceived duration of illness, less treatment control, more symptoms attributable to the illness, less understanding of, and stronger emotional reaction to the illness (p < 0.05). Satisfaction with the received information was associated with better illness perception on all subscales, except for personal control (p < 0.05). CONCLUSION: Improving the patients' illness perceptions by tailoring the information provision to the needs of patients may help patients to get a more coherent understanding of their illness and will possibly lead to a better health-related quality of life.

Using communication skills to improve adherence in children with chronic disease: the adherence equation.

Nonadherence to maintenance medication is common in paediatric chronic conditions. Despite the common belief that nonadherence is therapy-resistant, and the apparent lack of evidence for successful interventions to improve adherence, there is, in fact, a considerable body of evidence suggesting that adherence can be improved by applying specific communicative consultation skills. These can be summarized as the adherence equation: adherence=follow-up+dialogue+barriers and beliefs+empathy and education => concordance. Close follow-up of children with a chronic condition is needed to establish a therapeutic partnership with the family. Teaching self management skills is not a unidirectional process of providing information, but requires a constructive and collaborative dialogue between the medical team and the family. Identifying barriers to adherence can be achieved in a non-confrontational manner, by showing a genuine interest what the patient's views and preferences are. In particular, parental illness perceptions and medication beliefs should be identified, because they are strong drivers of nonadherence. Through empathic evidence-based education, such perceptions and beliefs can be modified. By applying these strategies, concordance between the child's family and the medical team can be achieved, resulting in optimal adherence to the jointly created treatment plan.

The prospective association between behavioural problems and asthma outcome in young asthma patients.

AIM: The aim of this prospective study was to examine the association between behavioural problems and medical and psychological outcomes in clinically treated children and adolescents with asthma. METHODS: Patients (n = 134) were recruited from two high-altitude asthma clinics in Switzerland and one asthma clinic in the Netherlands. Outcome measures were Asthma Control Test (ACT), Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S)), forced expiratory volume in 1 sec (FEV1 ) and fractional concentration of exhaled nitric oxide (FeNO). Parents completed the Child Behaviour Checklist (CBCL) (predictor variable). Data were collected at the start and end of treatment. Multiple regression analysis was used while adjusting for demographic variables, clinic and length of stay. RESULTS: More severe internalizing behavioural problems were associated with less improvement of total quality of life (t = -2.26, p = 0.03) and the domains symptoms (t = -2.04, p = 0.04) and emotions (t = -2.3, p = 0.02) after clinical treatment. Behavioural problems were not associated with a change of lung function measurements (FEV1 and FeNO) and asthma control (ACT) during treatment. CONCLUSION: A focus of healthcare professionals on the treatment of internalizing behavioural problems may optimize the quality of life in clinically treated youth with asthma.

Illness perceptions and quality of life in Japanese and Dutch women with breast cancer.

Knowledge on cross-cultural quality of life (QOL) and illness perceptions may help women with breast cancer cope more effectively. The self regulation model (SRM) guided the current exploratory longitudinal pilot-study. Central to SRM is the perception of health threats and their effects on QOL. Illness perceptions and QOL were assessed in 22 Dutch and 21 Japanese patients with breast cancer who filled out questionnaires before, 1 week, and 8 weeks after the first chemotherapy course. The questionnaires assessed QOL and illness perceptions. Patients' scores were compared with groups of patients with other chronic somatic illnesses (asthma, diabetes). Patients in both samples reported major impact of chemotherapy on global health status, physical functioning, role functioning, emotional functioning, constipation and diarrhea. Differences between Japanese and Dutch patients were limited to social functioning and financial problems. Japanese patients expressed stronger concerns about their illness than Dutch patients. Results of the Japanese and Dutch patients with breast cancer differed from data in patients with asthma on consequences, timeline, concern and emotional response. Results of Japanese patients differed from patients with type 2 diabetes on timeline and concern, whereas Dutch patients differed on timeline and consequences. Japanese and Dutch breast cancer patients have-overall-similar illness perceptions and QOL responses and are aware of the typical characteristics of their disease. The results support the feasibility of cross-cultural psychosocial research in oncology and offer implications for clinical interventions which impact on self-efficacy to empower patients with breast cancer.

Mapping EORTC-QLQ-C30 onto EQ-5D-5L Index in Indonesian Cancer Patients.

OBJECTIVE: This study aims to develop a mapping algorithm for EORTC QLQ-C30 to EQ-5D-5L which can produce utility values in patients with cancer. METHODS: We used a cross sectional study design with 300 cancer patients. The research instruments used were EORTC QLQ-C30 and EQ-5D-5L. Data were collected by interviewing cancer patients who were hospitalized in the Kasuari Installation of Dr Kariadi Hospital Semarang, Indonesia. The Ordinary Least Squares (OLS) regression method was used to predict the utility value of EQ-5D-5L. This study uses two models to predict utility values, namely model 1 with all domains, and model 2 with domains that affect the EQ-5D-5L. The predictive power of regression on the model is evaluated by calculating the mean absolute error (MAE) and root mean square error (RMSE) values. RESULT: The highest score in the functional domain is the 'emotional function' domain (mean: 85.89; SD: 16.04) and the highest symptom domain is 'weakness' (mean: 36.21; SD:21.69). The predicted utility values of models 1 and 2 are 0.683. The mean absolute error (MAE) and root mean square error (RMSE) values of model 1 are 0.128 and 0.173, while in model 2 the MAE and RMSE values obtained are 0.125 and 0.168. CONCLUSION: The development of the mapping algorithm from the EORTC QLQ-C30 to EQ-5D-5L instrument shows a predictive value of utility in a sample of patients with cancer at Dr. Kariadi Hospital, Semarang, Indonesia. The utility prediction in both model is similar, however model 2 involves fewer domains and symptoms.
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High inhaled corticosteroids adherence in childhood asthma: the role of medication beliefs.

Our aim was to study determinants of adherence in young asthmatic children over a 3-month period, including the role of parental illness and medication perceptions as determinants of adherence. Consecutive 2-6-yr-old children with asthma, using inhaled corticosteroids (ICS), followed-up at our paediatric asthma clinic (where patients are being extensively trained in self-management, and are followed-up closely) were enrolled. Adherence was measured electronically using a Smartinhaler® and calculated as a percentage of the prescribed dose. We examined the association of adherence to a range of putative determinants, including clinical characteristics and parental perceptions about illness and medication. Median (interquartile range) adherence, measured over 3 months in 93 children, was 92 (76-97)%, and most children had well controlled asthma. 94% of parents expressed the view that giving ICS to their child would protect him/her from becoming worse. Adherence was significantly associated with asthma control and with parental perceptions about medication. The high adherence rate observed in our study was associated with parental perceptions about ICS need. The high perceived need of ICS may probably be ascribed to the organisation of asthma care (with repeated tailored education and close follow-up).

Short-term versus long-term effects of depressive symptoms on mortality in patients on dialysis.

OBJECTIVE: Depressive symptoms seem to pose a risk factor for mortality among patients on dialysis. It is currently unknown whether the association is only short-lived and whether associations over time depend on specific causes of mortality. METHODS: In a prospective nationwide cohort study, 1528 patients with end-stage renal disease starting on dialysis completed the Mental Health Inventory. Patients were observed up to 5 years or until the end of follow-up in April 2011. Cox regression analyses were used to calculate associations between depressive symptoms and short-term (0-6 months), medium-term (6-24 months), or long-term (24-60 months) cardiovascular and noncardiovascular mortality. RESULTS: The adjusted hazard ratio (HR) was 1.43 (95% confidence interval [CI] = 1.08-1.88) for cardiovascular mortality and 2.07 (95% CI = 1.62-2.64) for noncardiovascular mortality. Depressive symptoms posed a strong risk factor for noncardiovascular mortality at the short term (HR = 2.82, 95% CI = 1.58-5.05), medium term (HR = 2.08, 95% CI = 1.40-3.09), and long term (HR = 1.84, 95% CI = 1.26-2.69), whereas the association between depressive symptoms and cardiovascular mortality was not observed during the first 6 months of follow-up (HR = 1.03, 95% CI = 0.49-2.15). CONCLUSIONS: Depressive symptoms at the start of dialysis therapy are associated with short-, medium-, and long-term mortality. The cause-specific mortality risk over time may help clinicians to understand multifactorial causes of the association between depressive symptoms and survival.

Oral contraceptives containing drospirenone for premenstrual syndrome.

BACKGROUND: Premenstrual syndrome (PMS) is a common problem. Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome. Combined oral contraceptives, which provide both progestin and estrogen, have been examined for their ability to relieve premenstrual symptoms. An oral contraceptive containing drospirenone and a low estrogen dose has been approved for treating PMDD in women who choose oral contraceptives for contraception. OBJECTIVES: To review all randomized controlled trials comparing a combined oral contraceptive containing drospirenone to a placebo or another combined oral contraceptive for effect on premenstrual symptoms. SEARCH METHODS: We searched for studies of drospirenone and premenstrual syndrome in the following databases: Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, and POPLINE (20 Dec 2011); EMBASE, LILACS, PsycINFO, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization (02 Mar 2011). We also examined references lists of relevant articles and wrote to known investigators to find other trials. SELECTION CRITERIA: We included randomized controlled trials in any language that compared a combined oral contraceptive (COC) containing drospirenone with a placebo or with another COC for effect on premenstrual symptoms. The primary outcome included affective and physical premenstrual symptoms that were prospectively recorded. Adverse events related to combined oral contraceptive use were examined. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed study quality. For continuous variables, the mean difference (MD) was computed with 95% confidence interval (CI). For dichotomous outcomes, the Peto odds ratio (OR) with 95% CI was calculated. MAIN RESULTS: We included five trials with a total of 1920 women. Two placebo-controlled trials of women with PMDD showed less severe premenstrual symptoms after three months with drospirenone 3 mg plus ethinyl estradiol 20 µg than with placebo (MD -7.92; 95% CI -11.16 to -4.67). The drospirenone group had greater mean decreases in impairment of productivity (MD -0.31; 95% CI -0.55 to -0.08), social activities (MD -0.29; 95% CI -0.54 to -0.04), and relationships (MD -0.30; 95% CI -0.54 to -0.06). Side effects more common with the use of the drospirenone COC contraceptive were nausea, intermenstrual bleeding, and breast pain. The respective odds ratios were 3.15 (95% CI 1.90 to 5.22), 4.92 (95% CI 3.03 to 7.96), and 2.67 (95% CI 1.50 to 4.78). Total adverse events related to the study drug were more likely for the drospirenone COC group (OR 2.36; 95% CI 1.62 to 3.44). Three trials studied the effect of drospirenone 3 mg plus ethinyl estradiol 30 µg on less severe symptoms. A placebo-controlled six-month trial had insufficient data for primary outcome analysis. Another six-month study used levonorgestrel 150 µg plus ethinyl estradiol 30 µg for the comparison group but did not provide enough data on premenstrual symptoms. In a two-year trial, the drospirenone COC group had similar premenstrual symptoms to the comparison group given desogestrel 150 µg plus ethinyl estradiol 30 µg (OR 0.87; 95% CI 0.63 to 1.22). The groups were also similar for adverse events related to treatment (OR 1.02; 95% CI 0.78 to 1.33). AUTHORS' CONCLUSIONS: Drospirenone 3 mg plus ethinyl estradiol 20 µg may help treat premenstrual symptoms in women with severe symptoms, that is, premenstrual dysphoric disorder. The placebo also had a large effect. We do not know whether the combined oral contraceptive works after three cycles, helps women with less severe symptoms, or is better than other oral contraceptives. Larger and longer trials of higher quality are needed to address these issues. Trials should follow CONSORT guidelines.

Preschool children with high adherence to inhaled corticosteroids for asthma do not show behavioural problems.

AIM: To assess prevalence of behavioural problems in preschool children with asthma with electronically verified exposure to inhaled corticosteroids (ICS). METHODS: Cross-sectional study of 81 children 2-5 years of age using daily ICS for persistent asthma. During 3 months' follow-up, adherence to ICS treatment was recorded by an electronical logging device (Smartinhaler(®)). Parents completed the Child Behavior Checklist 1.5-5 years (CBCL 1.5-5) to assess behavioural problems; results were compared to a published reference group of healthy children. RESULTS: The median (interquartile range) adherence to ICS was 92 (78-97) %. There was no difference in total CBCL score between children with asthma on ICS (mean, [SD] 32.10 [1.99]) and the reference group (33.30 [1.87], 95% CI for difference -6.62 to 4.22). Children with asthma were more likely to have somatic complaints (95% CI for difference 0.64 to 1.96) and less likely to have anxious/depressive symptoms (95% CI for difference -1.57 to -0.25) than the reference group. CBCL scores were not significantly related to the electronically measured adherence rates. CONCLUSIONS: Maintenance treatment with ICS, taken daily as prescribed, is not associated with an increased risk of behavioural problems in preschool children.