Trends in emotional functioning and psychosocial wellbeing in breast cancer survivors: a prospective cohort study using patient-reported outcome measures.

BACKGROUND: A breast cancer diagnosis can threaten every aspect of a woman's wellbeing, including her mental health. With the growing number of breast cancer survivors, studies addressing mental health in this population are of increasing importance now more than ever. Therefore, the current study investigated trends in emotional functioning and psychosocial wellbeing of breast cancer survivors, and the demographic and treatment characteristics that may influence these trends. METHODS: Prospectively collected data of women treated for breast cancer at the Erasmus MC were analyzed in this study using a cohort study design. Emotional functioning was measured using the EORTC-QLQ-C30, while psychosocial wellbeing was measured using the BREAST-Q. Type of surgery, age, family status and employment status of study participants were retrieved, and multilevel analyses were performed to identify trends in emotional functioning and psychosocial wellbeing and to determine the relationship between aforementioned characteristics and these outcomes. RESULTS: Three hundred thirty-four cancer survivors were analyzed. Psychosocial wellbeing declined, but emotional functioning showed a steady improvement over time. Women who underwent breast reconstruction showed a steeper increase in their emotional functioning, and women with no partner or children showed a marginal decline in psychosocial wellbeing between baseline and 12 months after surgery. CONCLUSIONS: These findings can be utilized by healthcare teams to identify breast cancer patients at risk for emotional problems and to provide adequate psychological support to those women who need help dealing with their emotions and self-concept in order to optimize clinical treatment.

Lifestyle treatment in women with polycystic ovary syndrome: predictors of weight loss and dropout.

BACKGROUND: Polycystic ovary syndrome (PCOS) affects 5%-10% of women in their reproductive years. Most women with PCOS struggle with obesity during their entire life. Knowing which determinants contribute to a successful lifestyle change is important to optimize treatment options for women with PCOS. OBJECTIVE: This analysis of secondary outcome measures aimed to determine factors of ≥5% weight loss and dropout in all arms of the study and separately in the lifestyle intervention (LI) and control (care as usual [CAU]) groups. STUDY DESIGN: Women diagnosed with PCOS (N = 183) and a Body Mass Index (BMI) above 25 kg/m2 were included. Participants were assigned to (1) 20 lifestyle sessions involving cognitive behavioral therapy (CBT), (2) 20 lifestyle sessions involving CBT with additional short message service (SMS), or (3) to control (CAU). A generalized linear regression was performed to identify determinants of ≥5% weight loss. Logistic regression was performed to identify determinants of dropout. All models were corrected by including baseline weight as a covariate. RESULTS: LI (OR 4.906, p = .001) was associated with ≥5% weight loss, while higher depression scores (OR 0.549, p = .013) had a negative association. Restraint eating was a positive factor for ≥5% weight loss in LI but a negative in CAU. Higher baseline weight (OR 1.033, p = .006), LI with SMS (OR 4.424, p = .002), and higher levels of androstenedione (OR 1.167, p = .026) were associated with dropout. CONCLUSIONS: Depression and eating behavior were associated with ≥5% weight loss. Women with PCOS should be screened for depression and eating behavior before a LI.

Changes in eating behavior through lifestyle treatment in women with polycystic ovary syndrome (PCOS): a randomized controlled trial.

BACKGROUND: Eating behaviors like emotional eating, external eating and restrained eating play an important role in weight gain and weight loss in the general population. Improvements in eating behavior are important for long-term weight. This has not yet been studied in women with Polycystic Ovary Syndrome (PCOS). The aim of this study is to examine if a three-component lifestyle intervention (LI) is effective for improving disordered eating behavior in women with PCOS. METHODS: Women diagnosed with PCOS (N = 183), with a body mass index (BMI) > 25 kg/m2 and trying to achieve a pregnancy were either assigned to 1 year of 20 group sessions of cognitive behavioral therapy (CBT) combined with nutritional advice and exercise with or without additional feedback through Short Message Service (SMS) or Care As Usual (CAU), which includes the advice to lose weight using publicly available services. RESULTS: The Eating Disorder Examination Questionnaire (EDEQ) scores worsened in CAU (47.5%) and improved in the LI (4.2%) at 12 months. The difference between the LI and CAU was significant (P = 0.007) and resulted in a medium to large effect size (Cohen's d: - 0.72). No significant differences were observed in EDEQ scores between LI with SMS compared to LI without SMS (Cohen's d: 0.28; P = 0.399). Also, weight loss did not mediate the changes in eating behavior. An overall completion rate of 67/183 (36.6%) was observed. CONCLUSIONS: A three-component CBT lifestyle program resulted in significant improvements in disordered eating behavior compared to CAU. Changes in disordered eating behavior are important for long-term weight loss and mental health. TRIAL REGISTRATION: NTR, NTR2450. Registered 2 August 2010, https://www.trialregister.nl/trial/2344.

A very short Symptom Checklist-90-R version for routine outcome monitoring in psychotherapy; The SCL-3/7.

OBJECTIVE: Routine outcome monitoring (ROM) is applied in many physical and mental health treatments. The treatment course is monitored with patient reported outcome measures (PROMs). A potential problem with PROM is response burden. This can be decreased by presenting such measures with less and better selected items. The SCL-90-R is an often used PROM for psychotherapies and a number of very short forms have been developed; the SCL-5, SCL-8, SCL-9 and SCL-10. This study aims to develop a new very short form, the symptom checklist 3 out of 7 (SCL-3/7) and to evaluate the effectiveness of these PROM with the precision relative to the complete SCL-90-R score. METHODS: Item Response Theory analysis was applied to select the 7 best discriminating items, evenly distributed over the latent trait. A routing serves that patients only need to administer 3 items. RESULTS: In a sample of 15,055 cases, the relative precisions of the SCL-3/7 were best for outpatients (122.7%), day care patients (111.8%) and inpatients (108.3). The SCL-5 was best for juvenile patients (110.0%), and the SCL-9 was best for addicted patients (107.2%). CONCLUSION: The SCL-3/7 decreases patient burden in ROM and has a better precision in adult therapies than other SCL-90 short forms.

Exploring health literacy and self-management after kidney transplantation: A prospective cohort study.

OBJECTIVE: Investigate the influence of health literacy and self-management on complications, kidney function and graft failure after kidney transplantation. METHODS: We included patients who received a kidney transplant between May 2012 and May 2013 and monitored outcomes until December 2018. Health literacy was measured using the Newest Vital Sign and self-management using the Partner in Health scale (before discharge, and after 6 and 12 months). Subscales are aftercare & knowledge, coping, recognition and management of symptoms, healthy lifestyle. Complications were categorized as rejection, viral infections, and bacterial infections. Kidney function was measured using eGFR and graft survival using days until failure. RESULTS: We included 154 patients. Higher health literacy at baseline and at 12 months was related to more viral infections (p = 0.02; p < 0.01). Lower 'coping' at baseline was related to more bacterial infections (p = 0.02). Higher 'after-care and knowledge' at 6 months (p < 0.01), and 'recognition and management of symptoms' at 6 months were associated with lower graft failure (p < 0.01). CONCLUSION: Health literacy did not influence kidney transplant related outcomes. Higher knowledge and management of symptoms were related to lower graft failure. PRACTICE IMPLICATIONS: Self-management support is a key focus for health care providers in the multidisciplinary team.

The effect of monomeric and oligomeric FLAVAnols in patients with type 2 diabetes and microalbuminuria (FLAVA-trial): A double-blind randomized controlled trial.

BACKGROUND & AIMS: Microalbuminuria is an early sign of vascular complications of type 2 diabetes and predicts cardiovascular disease and mortality. Monomeric and oligomeric flavanols (MOFs) are linked to improved vascular health. The aim of this study was to assess the effect of 3 months MOFs on albuminuria and endothelial function markers in patients with type 2 diabetes and microalbuminuria. METHODS: We conducted a double-blind, placebo-controlled trial among patients with type 2 diabetes and microalbuminuria. Patients with type 2 diabetes received either 200 mg MOFs or placebo daily on top of their habitual diet and medication. The primary endpoint was the between-group difference of the change in 24-h Albumin Excretion Rate (AER) over three months. Secondary endpoints were the between-group differences of the change in plasma levels of different markers of endothelial dysfunction. Mixed-modelling was applied for the longitudinal analyses. RESULTS: Participants (n = 97) were 63.0 ± 9.5 years old; diabetes-duration was 15.7 ± 8.5 years. Median baseline AER was 60 (IQR 20-120) mg/24 h. There was no within-group difference in median change of AER from baseline to 3 months in the intervention (0 (-35-21) mg/24 h, p = 0.41) or the control group (0 (-20-10) mg/24 h, p = 0.91). There was no between-group difference in the course of AER over three months (log-transformed data: ß = -0.02 (95%CI -0.23-0.20), p = 0.88), nor in the plasma levels of the endothelial dysfunction markers. CONCLUSION: Daily 200 mg MOFs for three months on top of habitual diet and usual care did not reduce AER and plasma markers of endothelial dysfunction compared to placebo, in patients with long-term type 2 diabetes and microalbuminuria. CLINICAL TRIALS REGISTRATION: NTR4669, www.trialregister.nl.

Implementation of the kidney team at home intervention: Evaluating generalizability, implementation process, and effects.

Research has shown that a home-based educational intervention for patients with chronic kidney disease results in better knowledge and communication, and more living donor kidney transplantations (LDKT). Implementation research in the field of renal care is almost nonexistent. The aims of this study were (1) to demonstrate generalizability, (2) evaluate the implementation process, and (3) to assess the relationship of intervention effects on LDKT-activity. Eight hospitals participated in the project. Patients eligible for all kidney replacement therapies (KRT) were invited to participate. Effect outcomes were KRT-knowledge and KRT-communication, and treatment choice. Feasibility, fidelity, and intervention costs were assessed as part of the process evaluation. Three hundred and thirty-two patients completed the intervention. There was a significant increase in KRT-knowledge and KRT-communication among participants. One hundred and twenty-nine out of 332 patients (39%) had LDKT-activity, which was in line with the results of the clinical trials. Protocol adherence, knowledge, and age were correlated with LDKT-activity. This unique implementation study shows that the results in practice are comparable to the previous trials, and show that the intervention can be implemented, while maintaining quality. Results from the project resulted in the uptake of the intervention in standard care. We urge other countries to investigate the uptake of the intervention.

Improvements in PCOS characteristics and phenotype severity during a randomized controlled lifestyle intervention.

RESEARCH QUESTION: What is the effect of weight loss through different interventions (three-component lifestyle intervention with short message service [SMS+] versus three-component lifestyle intervention without SMS [SMS-] versus care as usual [CAU]) on polycystic ovary syndrome (PCOS) characteristics (ovulatory dysfunction, hyperandrogenism, polycystic ovarian morphology [PCOM]) and phenotype distribution? DESIGN: Analysis of secondary outcome measures of a randomized controlled trial. Women diagnosed with PCOS (n = 183), who wished to become pregnant, with a body mass index above 25 kg/m², were assigned to a 1-year three-component (cognitive behavioural therapy, diet, exercise) lifestyle intervention group, with or without SMS, or to CAU (advice to lose weight). RESULTS: The prevalence of biochemical hyperandrogenism was 30.9% less in the SMS- group compared with CAU after 1 year (P = 0.027). Within-group analyses revealed significant improvements in ovulatory dysfunction (SMS+: -39.8%, P = 0.001; SMS-: -30.5%, P = 0.001; CAU: -32.1%, P < 0.001), biochemical hyperandrogenism (SMS-: -27.8%, P = 0.007) and PCOM (SMS-: -14.0%, P = 0.034). Weight loss had a significantly favourable effect on the chance of having ovulatory dysfunction (estimate 0.157 SE 0.030, P < 0.001) and hyperandrogenism (estimate 0.097 SE 0.027, P < 0.001). CONCLUSIONS: All groups demonstrated improvements in PCOS characteristics, although these were more profound within the lifestyle intervention groups. Weight loss per se led to an amelioration of diagnostic characteristics and in the phenotype of PCOS. A three-component lifestyle intervention aimed at a 5-10% weight loss should be recommended for all women with PCOS before they become pregnant.

Investigating online psychological treatment for adolescents with a visible difference in the Dutch YP Face IT study: protocol of a randomised controlled trial.

INTRODUCTION: This paper outlines the study protocol for the Dutch Young People (YP) Face IT Study. Adolescents with a visible difference (ie, disfigurement) often experience challenging social situations such as being stared at, receiving unwanted questions or being teased. As a consequence, some of these adolescents experience adverse psychosocial outcomes and appearance-related distress. To address this appearance-related distress, an online psychotherapeutic intervention, YP Face IT, has been developed. YP Face IT uses social interaction skills training and cognitive-behavioural therapy. The Dutch YP Face IT Study tests whether this intervention is effective in reducing social anxiety and improving body esteem. METHODS AND ANALYSIS: Participants are adolescents aged 12-18 with a visible difference and experiencing appearance-related distress. In this two-armed randomised controlled trial, 224 adolescents will be randomised to care as usual or YP Face IT. Adolescents will complete questionnaires at baseline, at 13 weeks and at 25 weeks. Primary outcomes are differences in social anxiety and body esteem between YP Face IT and care as usual. Secondary outcomes are differences in aspects of self-worth, perceived stigmatisation, health-related quality of life, life engagement, appearance-related distress and depressive symptoms between the two groups. ETHICS AND DISSEMINATION: Research ethics approval was obtained from the medical ethics review committee in Rotterdam (reference number MEC-2018-052/NL63955.078.18). Findings will be disseminated through academic peer-reviewed publications, conferences and newsletters to patient associations and participants of the study. TRIAL REGISTRATION NUMBER: The Netherlands Trial Register (NL7626).

Patient Experience Monitor (PEM): The Development of New Short-Form Picker Experience Questionnaires for Hospital Patients with a Wide Range of Literacy Levels.

PURPOSE: Several patient-reported experience measures (PREMs) were developed through the years. These questionnaires are frequently found to be inappropriate for people with lower literacy levels. This paper describes the development of patient experience questionnaires for hospital patients with a wide range of literacy levels, while enabling the potential for quality improvement. METHODS: Mixed methods were used to adapt Picker Institute patient experience questionnaires: selection of items and adaptation towards language level B1 (the language level of which patients can express their own opinion and describe experiences, events and expectations) by expert panels, usability tests with patients, analysis of psychometric properties and member checking. A theory-driven approach was followed for definitive enrolment of items, meaning that the items eligible for exclusion had been carefully reviewed by the expert team and representatives of a patient council before definitive exclusion. RESULTS: A pilot study was performed in an University Medical Centre in the Netherlands among in- and outpatients after discharge. Two provisional questionnaires of 22 items, designed by an expert panel, were reduced towards a final selection of 14-15 items. This led to two short-form questionnaires, called Patient Experience Monitor (PEM) Adult Inpatient and PEM Adult Outpatient. To illustrate, the results of the PEM Adult Outpatient questionnaire are presented. CONCLUSION: PEMs are short and valid questionnaires specifically developed to measure patient experiences of hospital patients with a wide range of literacy levels. Acceptance of the questionnaires for both lower and higher educated patients are confirmed by usability tests. The respondents of the pilot study represent both groups. The developed questionnaires should be seen as a dynamic entity and part of a continuous effort to evaluate and improve patient experiences. Future studies are needed to examine the usability of these new questionnaires for quality improvement.

Randomized Controlled Trial of a Spectacle Lens for Macular Degeneration.

SIGNIFICANCE: E-Scoop, a spectacle lens, provides no clinically relevant improvements on quality of life, visual acuity, and contrast sensitivity for patients with AMD. Because patients' burden is high and therapeutic options are scarce, the incentive to develop effective vision rehabilitation interventions remains. PURPOSE: Patients with AMD experience low quality of life due to vision loss, despite angiogenesis inhibitor interventions that slow down progression for some patients. E-Scoop, which includes low-power prisms, 6% magnification, yellow tint, and antireflection coating, might aid in daily activities by improving distance viewing. Separately, these features have little proven effectiveness. E-Scoop has not been formally tested. This study aimed to determine the impact of E-Scoop on quality of life and the effect on visual acuity and contrast sensitivity. METHODS: In this randomized controlled, open-label trial, 190 of 226 eligible patients were included. The primary outcome was quality of life measured with the 25-item National Eye Institute Visual Function Questionnaire. Secondary outcomes were visual acuity and contrast sensitivity. The follow-up for quality of life was after 6 weeks for controls and after 3 weeks of use for E-Scoop wearers. The visual measures were repeated after 6 weeks, with optimal refractive correction, with and without E-Scoop. RESULTS: Randomization resulted in 99 E-Scoop and 86 control group patients for intention-to-treat analysis. No differential change was found between the E-Scoop and control groups on the 25-item National Eye Institute Visual Function Questionnaire using Rasch analysis (Cohen d = -0.07, P = .53). Statistically significant but small effects were found in favor of E-Scoop on binocular visual acuity (mean difference, 0.05 logMAR [2.5 letters, P < .001]) and contrast sensitivity (mean difference, 0.10 logCS [2 letters, P < .001]). CONCLUSIONS: No effect of E-Scoop on quality of life was found. E-Scoop showed effects that were statistically significant, although not clinically meaningful and within typical variability, on visual measures.

Weight Reduction Through a Cognitive Behavioral Therapy Lifestyle Intervention in PCOS: The Primary Outcome of a Randomized Controlled Trial.

OBJECTIVE: Long-term weight loss is important and difficult to achieve for many women with polycystic ovary syndrome (PCOS). Lifestyle interventions (LS) in PCOS have shown moderate short-term effects. Three-component LS that combine nutrition advice, exercise, and cognitive behavioral therapy have not been tested in long-term interventions. METHODS: Women (N = 183) with PCOS who were trying to conceive and had BMI > 25 kg/m2 were assigned to 20 group sessions of cognitive behavioral therapy combined with nutrition advice and exercise (LS with or without Short Message Service [SMS] via mobile phone) or care as usual (CAU). RESULTS: More weight loss was observed in LS than in CAU (P < 0.001). Adding SMS was even more effective (P = 0.017). In CAU, 13 of 60 (21.8%) succeeded in achieving a 5% weight loss, as did 32 of 60 (52.8%) in LS without SMS and 54 of 63 (85.7%) in LS with SMS. The odds of achieving a 5% weight loss were 7.0 (P < 0.001) in LS compared with CAU. More than 18 of 60 (29.0%) of the women in CAU gained weight versus 5 of 60 (8.5%) and 2 of 63 (3.1%) in LS without or with SMS, respectively. The overall dropout rate was 116 of 183 (63.4%). CONCLUSIONS: A three-component LS program resulted in reasonable weight loss in women with PCOS. Adding SMS resulted in more weight loss.

Comparison of a home-based (multi) systemic intervention to promoting Medication AdheRence and Self-management among kidney transplant recipients with care-as-usual: the MARS randomized controlled trial protocol.

BACKGROUND: After kidney transplantation non-adherence and inadequate self-management undermine clinical outcomes and quality of life. Both have been demonstrated to be substantial in all age groups. However, interventions promoting adherence and self-management among kidney transplant recipients that have proven to be effective are scarce. In this study we aim to develop and test an intervention to optimize adherence and self-management. In this article we describe the background and design of the trial entitled 'promoting Medication AdheRence and Self-management among kidney transplant recipients' (MARS-trial)'. METHODS/DESIGN: This is a single-center, parallel arm randomized controlled trial. Nonadherent kidney transplant recipients aged 12 years or older are eligible for inclusion. Patients will be randomly assigned to either the experimental or a control group. The control group will receive care-as-usual. The experimental group will receive care-as-usual plus the MARS-intervention. The MARS-intervention is an outreaching intervention, based on the principles of (multi) systemic therapy which means involving the social network. A standardized intervention protocol is used for consistency but we will tailor the behavior change techniques used to the specific needs and determinants of each patient. The primary outcome of medication adherence will be measured using electronic monitoring. Secondary outcome measures regarding medication adherence and self-management are also assessed. Data is collected at baseline (T0), after a run-in period (T1), at six months post-baseline/end of treatment (T2) and after a six month follow-up period (T3). DISCUSSION: We combined elements of (multi) systemic therapy and evidence-based behavior change techniques to create an outreaching and highly individualized intervention. In this trial we will investigate the impact on medication adherence and self-management after kidney transplantation. TRIAL REGISTRATION: Netherlands Trial Register,trial number NTR7462. Registered 7th September 2018, https://www.trialregister.nl/trial/7264.

Sexual Function in Women With Polycystic Ovary Syndrome: Design of an Observational Prospective Multicenter Case Control Study.

INTRODUCTION: The prevalence of polycystic ovary syndrome (PCOS) is 10-15% in women of reproductive age. Its characteristics are (i) clinical or biochemical hyperandrogenism, (ii) oligomenorrhea or amenorrhea, and (iii) polycystic ovaries on ultrasound. PCOS is associated with lower quality of life, depression, anxiety, diabetes, and cardiovascular disease. Treatment commonly entails oral contraceptive use to lower endogenous androgen levels. Androgen levels and comorbidities may affect sexual function. Previous studies have addressed a limited range of possible contributing factors. We will assess sexual function as well as genital and self-reported sexual arousal in a laboratory setting in women with PCOS compared to an age-matched healthy control group. Modulation by biopsychosocial factors mentioned will be studied. METHODS: This is a multicenter prospective case control study. The study population includes healthy women with and without PCOS, aged 18-40 years, in a stable heterosexual relationship for at least 6 months. Power is calculated at 67 participants in each group. Anticipating a drop out of 10%, 150 participants will be recruited. MAIN OUTCOME MEASURES: The main outcomes measured are sexual function using the Female Sexual Function Index, Sexual Desire Inventory, and Female Sexual Distress Scale-Revised; genital sexual arousal measured as vaginal pulse amplitude; and self-reported sexual arousal in response to erotic stimuli in a laboratory setting. The mediators that will be investigated include testosterone, free androgen levels, oral contraceptive use, sensitivity to androgens (using CAG repeat length), body mass index, body image, mental health, and self-esteem. CONCLUSION: Strengths of this study are the inclusion of a broad range of biopsychosocial outcome measures including DNA analysis, a healthy control group, and standardized assessment of genital and self-reported sexual arousal in a laboratory setting. With the design of this study we aim to provide an insight into which biopsychosocial factors associated with PCOS are related to sexual function, and how sexual function may be affected by treatment. These new insights may help to improve clinical management of PCOS while improving the quality of life. Pastoor H, Both S, Timman R, et al. Sexual Function in Women With Polycystic Ovary Syndrome: Design of an Observational Prospective Multicenter Case Control Study. Sex Med 2020;8:718-729.

Risk Factors for Muscle Loss in Hemodialysis Patients with High Comorbidity.

With expanding kidney transplantation programs, remaining hemodialysis patients are more likely to have a high comorbidity burden and may therefore be more prone to lose muscle mass. Our aim was to analyze risk factors for muscle loss in hemodialysis patients with high comorbidity. Fifty-four chronic hemodialysis patients (Charlson Comorbidity Index 9.0 ± 3.4) were followed for 20 weeks using 4-weekly measurements of lean tissue mass, intracellular water, and body cell mass (proxies for muscle mass), handgrip strength (HGS), and biochemical parameters. Mixed models were used to analyze covariate effects on LTM. LTM (-6.4 kg, interquartile range [IQR] -8.1 to -4.8), HGS (-1.9 kg, IQR -3.1 to -0.7), intracellular water (-2.11 L, IQR -2.9 to -1.4) and body cell mass (-4.30 kg, IQR -5.9 to -2.9) decreased in all patients. Conversely, adipose tissue mass increased (4.5 kg, IQR 2.7 to 6.2), resulting in no significant change in body weight (-0.5 kg, IQR -1.0 to 0.1). Independent risk factors for LTM loss over time were male sex (-0.26 kg/week, 95% CI -0.33 to -0.19), C-reactive protein above median (-0.1 kg/week, 95% CI -0.2 to -0.001), and baseline lean tissue index ³10th percentile (-1.6 kg/week, 95% CI -2.1 to -1.0). Age, dialysis vintage, serum albumin, comorbidity index, and diabetes did not significantly affect LTM loss over time. In this cohort with high comorbidity, we found universal and prominent muscle loss, which was further accelerated by male sex and inflammation. Stable body weight may mask muscle loss because of concurrent fat gain. Our data emphasize the need to assess body composition in all hemodialysis patients and call for studies to analyze whether intervention with nutrition or exercise may curtail muscle loss in the most vulnerable hemodialysis patients.

Six and eight weeks injection frequencies of bevacizumab are non-inferior to the current four weeks injection frequency for quality of life in neovascular age-related macular degeneration: a randomized controlled trial.

PURPOSE: Patients with neovascular age-related macular degeneration (nARMD) will not deteriorate on visual acuity and retinal thickness when treated with bevacizumab injection frequencies of 6 or 8 weeks compared to 4 weeks. This study aimed to investigate this non-inferiority in quality of life (QoL). We hypothesized that less frequent bevacizumab injections are not inferior regarding patients reported QoL. METHODS: Patients were randomized to bevacizumab every 4 (n = 64), 6 (n = 63), and 8 weeks (n = 64). Patients were at least 65 years old, have a best-corrected visual acuity of 20/200 to 20/20, no previous ARMD treatment and active leakage. Vision-related QoL questionnaire NEI VFQ-39 was used to assess QoL at baseline and after 1 year. General QoL questionnaire SF-36 was included for secondary analysis. Multilevel analyses were performed, correcting for age, gender and baseline. RESULTS: The 6 (3.68; 95% CI - 0.63 to 8.00) and 8 (2.15; 95% CI - 2.26 to 6.56) weeks bevacizumab regimens resulted in non-inferior QoL differences compared to 4 weeks on the NEI VFQ-39. Also on the SF-36 the differences were well within the non-inferiority limits. CONCLUSION: Non-inferiority of the 6 and 8 weeks frequencies was demonstrated compared to 4 weeks on vision-related and general QoL in patients with nARMD. These results are in line with previously published results of lower frequency injections regarding visual acuity and central retinal thickness. Lower injection frequency may reduce burden, side effects, and treatment costs. In consideration of these results, 8 weeks frequency injections of intravitreal bevacizumab could be considered in patients with nARMD.

Long-term effects of a three-component lifestyle intervention on emotional well-being in women with Polycystic Ovary Syndrome (PCOS): A secondary analysis of a randomized controlled trial.

Many women with Polycystic Ovary Syndrome (PCOS) report high depression rates. The relationship between PCOS and these high depression rates is unclear. Two-component lifestyle interventions have revealed short-term effects on depression scores in this group of women. In general, 3-component interventions including diet, exercise, and cognitive behavioral therapy (CBT) are more effective in the long-term to improve emotional well-being. This has not yet been studied in women with PCOS. This study examined the effect of 20 CBT lifestyle (LS) sessions combined with a healthy diet and physical therapy with or without 9 months additional feedback through Short Message Service (SMS) via mobile phone, compared to care as usual (CAU, involving advice to lose weight). In this secondary analysis, 155 women with PCOS and a BMI above 25 kg/m2 were eligible. Depression scores decreased significantly in the LS programme compared to CAU (P = 0.045). In both the LS programme without SMS (P = 0.036) and the LS programme with SMS (P = 0.011) depression scores decreased while no change was observed in CAU (P = 0.875). Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027). No differences in body image scores were observed in LS participants compared to CAU (P = 0.087), although body image improved significantly in both the LS without SMS (P = 0.001) and with SMS (P = 0.008) study arms. We found no significant mediating role by androgens in the relationship between LS participants and emotional well-being. Only weight-loss mediated the relationship between LS and self-esteem. To conclude, a three-component lifestyle intervention programme with or without additional SMS resulted in significant improvements in depression and self-esteem compared to CAU, in women with PCOS, obesity, and a wish to achieve a pregnancy. Testosterone, androstenedione, DHEA, insulin, HOMA-IR, and cortisol did not mediate this effect. Weight loss mediated the effects on self-esteem but not on depression and body-image. This suggests that lifestyle treatment independent of weight loss can reduce depression and body-image, but both lifestyle treatment and weight loss can improve self-esteem. Thus, a three-component lifestyle intervention based on CBT could prove successful in improving mood in women with PCOS who are overweight or obese and attempting to become pregnant.

Postoperative parathyroid hormone levels as a predictor for persistent hypoparathyroidism.

OBJECTIVE: Hypoparathyroidism is a common complication after thyroidectomy. It is not yet possible to predict in which patients hypoparathyroidism will persist. We aim to determine whether a decrease in PTH levels, measured at the first postoperative day, can identify patients with a high risk for persistent hypoparathyroidism one year after thyroidectomy. DESIGN: Prospective multi-center cohort study. METHODS: Patients undergoing total or completion thyroidectomy were included. We measured PTH levels preoperatively and on the first postoperative day. Primary outcome is the proportion of patients with persistent hypoparathyroidism, defined as the need for calcium supplementation one year after surgery. RESULTS: We included 110 patients of which 81 were used for analysis of the primary outcome. At discharge 72.8% of patients were treated with calcium supplementation. Persistent hypoparathyroidism was present in 14 patients (17.3%) at one-year follow-up, all of them had a decrease in PTH >70% at the first postoperative day. These 14 were 43.8% of the 32 patients who had such a decrease. In the group of 49 patients (59.8%) without a PTH >70% decrease, none had persistent hypoparathyroidism one year after surgery (P-value <0.001). A decrease of >70% in PTH levels had a sensitivity of 100.0% (95% CI: 85.8-100.0%), a specificity of 73.1% (95% CI: 62.5-83.7%) and an area under the curve of 0.87 (95% CI: 0.79-0.94) to predict the risk for persistent hypoparathyroidism. CONCLUSION: In our study a decrease in PTH levels of >70% after total or completion thyroidectomy is a reliable predictor for persistent hypoparathyroidism, and this should be confirmed in larger cohorts.

A very short version of the Visual Function Questionnaire (VFQ-3oo7) for use as a routinely applied Patient-Reported Outcome Measure.

BACKGROUND: Patient-reported outcome measures (PROMs) are valuable supplements in regular care to facilitate routine monitoring of quality of life from the patient's perspective. The 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) is a widely used PROM in ophthalmology. However, the NEI-VFQ-25 is too time-consuming and cumbersome for routine evaluations in regular care. The aim of this study is to construct a 7-item questionnaire of which only 3 items are presented to the patient, by means of routing. This VFQ 3 out of 7 (VFQ-3oo7) should have a minimal loss of information compared with the NEI-VFQ-25. METHODS: An historical database including 3293 administrations of the NEI-VFQ-25 was constructed involving patients with retinal detachment, cataract, corneal diseases, glaucoma, macular degeneration, uveal melanoma and a normal population sample. The data were subjected to Rasch analyses, in particular a generalized partial credit model. Items were sorted on the latent trait and divided into seven categories. From each category, the item with the highest discriminative value was selected. Through routing, only three out of the seven remaining questions are used, where the answers navigate patients to a fitting trait level. RESULTS: A one-dimensional structure was considered fitting. The VFQ-3oo7 showed a small loss of information compared with the total score of the NEI-VFQ-25: correlation 0.927 and a relative precision of 0.868. CONCLUSION: The very short, but valid, VFQ-3oo7 can be applied to evaluate the patient's perceived vision-related health status in routine evaluations of treatments in regular care, with a small burden for patients.

The influence on quality of life of intermittent scheduling in first- and second-line chemotherapy of patients with HER2-negative advanced breast cancer.

BACKGROUND: The Stop&Go study randomized patients with advanced breast cancer to intermittent (two times four) or continuous (eight subsequent cycles) first- and second-line chemotherapy. METHODS: QoL was measured with RAND-36 questionnaires every 12 weeks. The primary objective was to estimate differences in changes from baseline between intermittent and continuous treatment. An effect size of 0.5 SD (5 points) was considered clinically meaningful. RESULTS: A total of 398 patients were included with a median follow-up of 11.4 months (IQR 5.6-22.2). Mean physical QoL baseline scores were 38.0 resp. 38.2, and mental scores 45.0 resp. 42.4 for intermittent and continuous treatment. Physical QoL declined linearly in the intermittent arm causing a clinically meaningful difference of 5.40 points at 24 months (p < 0.001), while scores in the continuous arm stabilized after a small decline of ± 3.4 points at 12 months. Conversely, mental QoL was fairly stable and even improved with 1.58 (p = 0.005) and 2.48 points (p < 0.001) at 12 months for intermittent and continuous treatment, respectively. When comparing arms for both components in changes from baseline, the maximum differences were 2.46 (p = 0.101) and 1.95 points (p = 0.182) for physical and mental scores, both measured at 30 months and in favor of continuous treatment. CONCLUSION: Intermittent first- and second-line chemotherapy in patients with HER2-negative advanced breast cancer showed a trend for worse impact on QoL compared to continuous chemotherapy, with neither significant nor meaningful differences in course. We recommend prescribing chemotherapy continuously until progressive disease or unacceptable toxicity. Trial registration EudraCT 2010-021519-18; BOOG 2010-02.