Treatment of age-related macular degeneration with aflibercept using a treat, extend and fixed protocol; A 4-year study of treatment outcomes, durability, safety and quality of life (An extension to the MATE randomised controlled trial).

PURPOSE: Data are limited pertaining to the long-term benefits of aflibercept treatment for neovascular age-related macular degeneration (nAMD). The aim of this study was to provide outcomes, safety, durability and quality-of-life data with aflibercept using a modified treat, extend and fixed regime over 4 years. METHODS: Prospective, multicentre, single cohort observational study of treatment-naïve nAMD participants treated with aflibercept as 2-year extension of the MATE-trial that compared early and late Treat-and-Extend for 2 years. Refracted ETDRS best corrected visual acuity (BCVA), central retinal thickness (CRT), treatment interval and adverse events were assessed. Quality-of-life was measured using the Macular Disease Dependent Quality of Life (MacDQoL) and Macular Disease Treatment Satisfaction Questionnaires (MacTSQ). RESULTS: Twenty-six of 40 participants completing the MATE-trial were enrolled with 20 completing the total 4-year study. Mean BCVA was 60.7 at Month 0 and 64.8 ETDRS letters at Month 48 while CRT decreased from 423.7 µm to 292.2 µm. Five participants discontinued treatment due to inactivity. The mean number of treatments and visits for the remaining participants was 27 and 30.0, respectively, with treatment intervals extended to 12 weeks in four participants at Month 48. Both AMD-specific QoL and treatment satisfaction remained stable between Months 0 and 48 and mean BCVA significantly correlated with AMD-specific QoL scores at Months 12, 24 and 48. CONCLUSIONS: Results suggest that BCVA can be maintained over 48 months when following a treat-extend-and-fix regimen of aflibercept with intervals out to 12 weeks, while maintaining AMD-specific QoL and treatment satisfaction.

The MATE trial: a multicentre, mixed-methodology, pilot, randomised controlled trial in neovascular age-related macular degeneration.

BACKGROUND/OBJECTIVES: In healthcare research investigating complex interventions, gaps in understanding of processes can be filled by using qualitative methods alongside a quantitative approach. The aim of this mixed-methods pilot trial was to provide feasibility evidence comparing two treatment regimens for neovascular age-related macular degeneration (nAMD) to inform a future large-scale randomised controlled trial (RCT). SUBJECTS/METHODS: Forty-four treatment-naïve nAMD patients were followed over 24 months and randomised to one of two treatment regimens: standard care (SC) or treat and extend (T&E). The primary objective evaluated feasibility of the MATE trial via evaluations of screening logs for recruitment rates, nonparticipation and screen fails, whilst qualitative in-depth interviews with key study staff evaluated the recruitment phase and running of the trial. The secondary objective assessed changes in visual acuity and central retinal thickness (CRT) between the two treatment arms. RESULTS: The overall recruitment rate was 3.07 participants per month with a 40.8% non-participation rate, 18.51% screen-failure rate and 15% withdrawal/non-completion rate. Key themes in the recruitment phase included human factors, protocol-related issues, recruitment processes and challenges. Both treatment regimens showed a trend towards a visual acuity gain at month 12 which was not maintained at month 24, whilst CRT reduced similarly in both regimens over the same time period. These were achieved with one less treatment following a T&E regimen. CONCLUSION: This mixed-methodology, pilot RCT achieved its pre-defined recruitment, nonparticipation and screen failure rates, thus deeming it a success. With some minor protocol amendments, progression to a large-scale RCT will be achievable.

Parental terminal cancer and dependent children: a systematic review.

BACKGROUND: When a parent has terminal cancer, their children are part of that experience. Parents often want to protect their children from their disease and prognosis. Knowledge of dependent children's experience will help ensure they receive appropriate support. To date, there is lack of synthesis of this evidence examining children's perspectives. OBJECTIVES: To systematically search and synthesise the qualitative literature exploring the experiences of dependent children when their parent has terminal cancer. METHODS: Databases of MEDLINE, Embase, PsycINFO, CINAHL, Assia and the Cochrane library were searched systematically from inception to July 2020 to determine eligible studies. Included studies were appraised for quality and thematically synthesised using Thomas and Harden's thematic synthesis framework. RESULTS: Fourteen studies were included, which interviewed children about their experiences (n=654 children aged 4-18 years at the time of parental death), from six countries. Five descriptive themes were identified, further categorised into two broad themes: (1) finding out about parental cancer and its impact on the family and (2) coping with life with parental cancer, death and beyond. CONCLUSION: Children want to be involved in their parent's cancer experience and to help support the family. Healthcare professionals are ideally placed to support and encourage parents to include their children. They should reassure parents that children can cope well and that maintaining normality will help, and explain the benefits of honest and open communication and how they can include dependent children from diagnosis and beyond.

An integrated understanding of the complex drivers of emergency presentations and admissions in cancer patients: Qualitative modelling of secondary-care health professionals' experiences and views.

The number of cancer-related emergency presentations and admissions has been steadily increasing in the UK. Drivers of this phenomenon are complex, multifactorial and interlinked. The main objective of this study was to understand the complexity of emergency hospital use in cancer patients. We conducted semi-structured interviews with 42 senior clinicians (20 doctors, 22 nurses) with diverse expertise and experience in caring for acutely ill cancer patients in the secondary care setting. Data analysis included thematic analysis and purposive text analysis to develop Causal Loop Diagrams. Our Causal Loop Diagrams represent an integrated understanding of the complex factors (13) influencing emergency hospital use in cancer patients. Eight factors formed five reinforcing feedback loops and therefore were high-leverage influences: Ability of patients and carers to self-care and cope; Effective and timely management of ambulatory care sensitive conditions by primary and community care; Sufficient and effective social care for patients and carers; Avoidable emergency hospital use; Bed capacity; Patients accessing timely appropriate specialist inpatient or ambulatory care; Prompt and effective management and prevention of acute episode; Timely and safe discharge with appropriate support. The loops show that reduction of avoidable hospital use helps relieve hospital bed pressure; improved bed capacity then has a decisive, positive influence on patient pathway and thus outcome and experience in the hospital; in turn, better in-hospital care and discharge help patients and carers self-care and cope better back home with better support from community-based health and social care services, which then reduces their future emergency hospital use. To optimise acute and emergency cancer care, it is also essential that patients, carers and other clinicians caring for cancer patients have prompt access to senior cancer specialists for advice, assessment, clinical decision and other support. The findings provide a useful framework and focus for service planners aiming to optimise care.

Emergency admissions and subsequent inpatient care through an emergency oncology service at a tertiary cancer centre: service users' experiences and views.

PURPOSE: Avoiding unnecessary emergency admissions and managing those that are admitted more effectively is a major concern for both patients and health services. To generate evidence useful for improving services for direct patient benefit, this study explores service users' views and experiences of emergency admissions and subsequent inpatient care. METHODS: Participants were recruited during a cancer-related emergency admission from a tertiary cancer centre with an emergency oncology service and emergency department. Semi-structured interviews were conducted with 15 patients and 12 carers post hospital discharge. Interview transcripts were analyzed using framework analysis. RESULTS: Twenty patients experienced 43 emergency admissions over 6 months. Most admissions (35/43) followed patients presenting acutely or as emergencies with cancer treatment side effects. Most admissions (35/43) were directly to an oncology ward following specialist advice, review and triage, and thus unavoidable. Participants experienced outstanding inpatient care because of the following: prompt and effective symptom control and stabilization of acute conditions; continuity of cancer care and coordination between acute and long-term treatment; satisfactory professional-patient communication and information sharing; responsive, motivated and competent staff; and less restrictive visiting times. Gaps in care were identified. CONCLUSIONS: Many emergency admissions are necessary for people with cancer. Future work should focus on improving easy access to specialist advice and triage, and the process of admission; providing rapid palliation of symptoms and prompt stabilization of acute conditions, and satisfactory inpatient care; closing the circle of care for patients by actively involving primary care and palliative/end-of-life care services to address the complex needs of patients and carers.

Cancer patients' experiences of living with venous thromboembolism: A systematic review and qualitative thematic synthesis.

BACKGROUND: Cancer-associated thrombosis is common. Recommended treatment is daily injected low-molecular-weight heparin for 6 months. Most studies focus on prophylaxis and treatment; few have explored the patients' experience. AIMS: To identify and synthesise the available literature concerning patients' experience of cancer-associated thrombosis. DESIGN: Systematic literature review and qualitative thematic synthesis. DATA SOURCE: MEDLINE, Embase, CINAHL, PsycINFO (until 10/2016; limited to English) were searched. Eligible papers were qualitative studies of adult patients' experience of cancer-associated thrombosis. Two researchers screened titles/abstracts/papers against inclusion criteria with recourse to a third for disagreements. Critical Appraisal Skills Programme qualitative checklist tool was used for quality appraisal. RESULTS: A total of 1397 articles were identified. Five qualitative studies (total n = 92; age range 32-84 years) met the inclusion criteria. Participants had various cancer types. Most had advanced disease and were receiving palliative care. Four major themes emerged from the data: knowledge deficit (patients and clinicians), effects of cancer-associated thrombosis (physical and psychological), effects of anticoagulation and coping strategies. CONCLUSION: The cancer journey is difficult in itself, but thrombosis was an additional, frightening and unexpected burden. Although the association between cancer and thromboembolism is well-known, cancer patients are not routinely educated about the risk or warning symptoms/signs of thromboembolism which may otherwise be misattributed to the cancer by patient and clinician alike. This systematic review highlights the impact of cancer-associated thrombosis on the lives of cancer patients, and calls for education for patients and clinicians to be part of routine care and further work to address this patient priority.

A Thematic Synthesis of the Experiences of Adults Living with Hemodialysis.

BACKGROUND AND OBJECTIVES: Patients on in-center dialysis spend significant amounts of time in the dialysis unit; additionally, managing ESRD affects many aspects of life outside the dialysis unit. To improve the care provided to patients requiring hemodialysis, their experiences and beliefs regarding treatment must be understood. This systematic review aimed to synthesize the experiences of patients receiving in-center hemodialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We searched Embase, MEDLINE, CINAHL, PsychINFO, Google Scholar, and reference lists for primary qualitative studies published from 1995 to 2015 that explored the experiences of adult patients receiving treatment with in-center hemodialysis. A thematic synthesis was conducted. RESULTS: Seventeen studies involving 576 patients were included in the synthesis. Four analytic themes were developed. The first theme (a new dialysis-dependent self) describes the changes in identity and perceptions of self that could result from dialysis dependence. The second theme (a restricted life) describes the physical and emotional constraints that patients described as a consequence of their dependence. Some patients reported strategies that allowed them to regain a sense of optimism and influence over the future, and these contributed to the third theme (regaining control). The first three themes describe a potential for change through acceptance, adaption, and regaining a sense of control. The final theme (relationships with health professionals) describes the importance of these relationships for in-center patients and their influence on perceptions of power and support. These relationships are seen to influence the other three themes through information sharing, continuity, and personalized support. CONCLUSIONS: Our synthesis has resulted in a framework that can be used to consider interventions to improve patients' experiences of in-center hemodialysis care. Focusing on interventions that are incorporated into the established relationships that patients have with their health care professionals may enable patients to progress toward a sense of control and improve satisfaction with care.