Purpose: To investigate detailed patient experiences specific to receiving vascular endothelial growth factor inhibitors (anti-VEGF) for wet Age-Related Macular Degeneration (wAMD), and to acquire a snapshot of the frequency of clinically significant levels of depression, anxiety and post-traumatic stress among patients and levels of burden in patients' carers. Design: Observational cross-sectional mixed-methods study Methods: 300 patients with wAMD receiving anti-VEGF treatment and 100 patient carers were recruited. Qualitative data on patients' experience of treatment were collected using a structured survey. Standardised validated questionnaires were used to quantify clinically significant levels of anxiety, depression, post-traumatic stress, as well as cognitive function and carers' burden. Results: Qualitative data showed that 56% of patients (n =132) reported anxiety related to anti-VEGF treatment. The main sources of anxiety were fear of going blind due to intravitreal injections, and concerns about treatment effectiveness rather than around pain. From validated questionnaires, 17% of patients (n=52) showed clinical levels of anxiety, and 12% (n=36) showed clinical levels of depression. Depression levels, but not anxiety, were significantly higher in patients who received up to 3 injections compared to patients who received from 4 to 12 injections (ANOVA P=.027) and compared to patients who received more than 12 injections (ANOVA P=.001). Conclusions: Anti-VEGF treatment is often experienced with some anxiety related to treatment regardless of the number of injections received. Clinical levels of depression seem to be more frequent in patients at early stages of anti-VEGF treatment. Strategies to improve patient experience of treatment and minimise morbidity are suggested.Key Words: Wet Age-Related Macular Degeneration; Anti-VEGF; Depression; Anxiety; Experience.Abstract (MUST be submitted as a separate file) 1

This review has found that a wide range of internal and external factors impact the FP decision-making process. Key external issues related to current service delivery such as the provision and timing of FP information, and lack of referral from oncology to the fertility clinic. However, internal issues such as women's fears concerning the perceived risks associated with pursuing FP also hindered decision-making but these 'risks' were typically overestimated and non-evidence based. These findings suggest that the implementation of a range of decision support interventions may be of benefit within the clinical care pathway of FP and cancer. Women would benefit from the provision of more evidence-based FP information, ideally received at cancer diagnosis, in advance of seeing a fertility specialist, for example through the implementation of patient decision aids. Healthcare professionals in both oncology and fertility services may also benefit from the implementation of training programmes and educational tools targeted at improving the communication skills needed to improve collaborative decision-making and deliver care that is patient-centred. Exploration of the current barriers, both intellectual and practical, that prevent some patients from accepting FP will help care providers to do better for their patients in the future. Finally, the extent to which a poorer prognosis and moral, ethical and religious beliefs influence the FP decision-making process also warrant further research.

The results indicate that better information and support resources aimed at women to support their decision making are needed, such as patient decision-aids. Women from Group 1 were found to suffer significantly worse depression compared with the general UK population, highlighting the need for psychological support in the FP care-pathway and for research exploring the contributions of depression and hopelessness to the decision-making process.

IntroductionWomen diagnosed with cancer and facing potentially sterilising cancer treatment have to make time-pressured decisions regarding fertility preservation with specialist fertility services while undergoing treatment of their cancer with oncology services. Oncologists identify a need for resources enabling them to support women's fertility preservation decisions more effectively; women report wanting more specialist information to make these decisions. The overall aim of the ‘Cancer, Fertility and Me’ study is to develop and evaluate a new evidence-based patient decision aid (PtDA) for women with any cancer considering fertility preservation to address this unmet need.Methods and analysisThis is a prospective mixed-method observational study including women of reproductive age (16 years +) with a new diagnosis of any cancer across two regional cancer and fertility centres in Yorkshire, UK. The research involves three stages. In stage 1, the aim is to develop the PtDA using a systematic method of evidence synthesis and multidisciplinary expert review of current clinical practice and patient information. In stage 2, the aim is to assess the face validity of the PtDA. Feedback on its content and format will be ascertained using questionnaires and interviews with patients, user groups and key stakeholders. Finally, in stage 3 the acceptability of using this resource when integrated into usual cancer care pathways at the point of cancer diagnosis and treatment planning will be evaluated. This will involve a quantitative and qualitative evaluation of the PtDA in clinical practice. Measures chosen include using count data of the PtDAs administered in clinics and accessed online, decisional and patient-reported outcome measures and qualitative feedback. Quantitative data will be analysed using descriptive statistics, paired sample t-tests and CIs; interviews will be analysed using thematic analysis.Ethics and disseminationResearch Ethics Committee approval (Ref: 16/EM/0122) and Health Research Authority approval (Ref: 194751) has been granted. Findings will be published in open access peer-reviewed journals, presented at conferences for academic and health professional audiences, with feedback to health professionals and program managers. The Cancer, Fertility and Me patient decision aid (PtDA) will be disseminated via a diverse range of open-access media, study and charity websites, professional organisations and academic sources. External endorsement will be sought from the International Patient Decision Aid Standards (IPDAS) Collaboration inventory of PtDAs and other relevant professional organisations, for example, the British Fertility Society.Trial registration numberNCT02753296; pre-results.

People with severe mental illness (SMI) have reduced life expectancy compared with the general population, which can be explained partly by their increased risk of diabetes. We conducted a meta-analysis to determine the clinical effectiveness of pharmacological and non-pharmacological interventions for improving glycaemic control in people with SMI (PROSPERO registration: CRD42015015558). A systematic literature search was performed on 30/10/2015 to identify randomised controlled trials (RCTs) in adults with SMI, with or without a diagnosis of diabetes that measured fasting blood glucose or glycated haemoglobin (HbA1c). Screening and data extraction were carried out independently by two reviewers. We used random effects meta-analysis to estimate effectiveness, and subgroup analysis and univariate meta-regression to explore heterogeneity. The Cochrane Collaboration’s tool was used to assess risk of bias. We found 54 eligible RCTs in 4,392 adults (40 pharmacological, 13 behavioural, one mixed intervention). Data for meta-analysis were available from 48 RCTs (n = 4052). Both pharmacological (mean difference (MD), -0.11mmol/L; 95% confidence interval (CI), [-0.19, -0.02], p = 0.02, n = 2536) and behavioural interventions (MD, -0.28mmol//L; 95% CI, [-0.43, -0.12], p<0.001, n = 956) were effective in lowering fasting glucose, but not HbA1c (pharmacological MD, -0.03%; 95% CI, [-0.12, 0.06], p = 0.52, n = 1515; behavioural MD, 0.18%; 95% CI, [-0.07, 0.42], p = 0.16, n = 140) compared with usual care or placebo. In subgroup analysis of pharmacological interventions, metformin and antipsychotic switching strategies improved HbA1c. Behavioural interventions of longer duration and those including repeated physical activity had greater effects on fasting glucose than those without these characteristics. Baseline levels of fasting glucose explained some of the heterogeneity in behavioural interventions but not in pharmacological interventions. Although the strength of the evidence is limited by inadequate trial design and reporting and significant heterogeneity, there is some evidence that behavioural interventions, antipsychotic switching, and metformin can lead to clinically important improvements in glycaemic measurements in adults with SMI.