Evidence of quality of life for hospitalised patients with COVID-19: a scoping review.

Background: Information on the quality of life of people hospitalised with COVID-19 is important, both in assessing the burden of disease and the cost-effectiveness of treatments. However, there were potential barriers to collecting such evidence. Objective: To review the existing evidence on quality of life for people hospitalised with COVID-19, with a focus on the amount of evidence available and methods used. Design: A scoping review with systematic searches. Results: A total of 35 papers were selected for data extraction. The most common study type was economic evaluation (N = 13), followed by cross-sectional (N = 10). All economic evaluations used published utility values for other conditions to represent COVID-19 inpatients' quality of life. The most popular quality-of-life survey measure was the Pittsburgh Sleep Quality Index (N = 8). There were 12 studies that used a mental health-related survey and 12 that used a sleep-related survey. Five studies used EQ-5D, but only one collected responses from people in the acute phase of COVID-19. Studies reported a negative impact on quality of life for people hospitalised with COVID-19, although many studies did not include a formal comparison group. Limitations: Although it used systematic searches, this was not a full systematic review. Conclusion: Quality-of-life data were collected from people hospitalised with COVID-19 from relatively early in the pandemic. However, there was a lack of consensus as to what survey measures to use, and few studies used generic health measures. Economic evaluations for COVID-19 treatments did not use utilities collected from people with COVID-19. In future health crises, researchers should be vigilant for opportunities to collect quality-of-life data from hospitalised patients but should try to co-ordinate as well as ensuring generic health measures are used more. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR132254.

Quality of life can be measured using short, simple surveys. It is important to assess quality of life in this way, as it can show how health conditions affect people. Quality-of-life surveys can also be used to measure how treatments benefit people and to judge whether it is cost-effective to fund them. COVID-19 is a new disease, with new treatments developed to treat it. COVID-19 also created possible barriers to collecting quality-of-life survey data, especially from people in hospital at the start of the pandemic. This paper reviews studies which report data on quality of life for people hospitalised with COVID-19, especially how much evidence is available and how the studies were carried out. There were 35 studies included in the review. Of these, 13 assessed how cost-effective treatments for COVID-19 were. None of them collected survey responses directly from patients. Instead, they used data previously collected from people with other conditions such as influenza to represent people with COVID-19's quality of life. The studies which did collect data from patients used a wide variety of different surveys, which made comparing their results difficult. Mental health-related surveys were used by 12 studies, and a further 12 used sleep-related surveys. Relatively few studies used general surveys which could assess the overall effect of COVID-19 on people's quality of life. In future health crises, we recommend using more general quality-of-life measures. We also recommend that researchers co-ordinate to reduce the number of different surveys they use, as this will make comparing results easier.

A Phase II trial of Higher RadiOtherapy Dose In The Eradication of early rectal cancer (APHRODITE): protocol for a multicentre, open-label randomised controlled trial.

INTRODUCTION: The standard of care for patients with localised rectal cancer is radical surgery, often combined with preoperative neoadjuvant (chemo)radiotherapy. While oncologically effective, this treatment strategy is associated with operative mortality risks, significant morbidity and stoma formation. An alternative approach is chemoradiotherapy to try to achieve a sustained clinical complete response (cCR). This non-surgical management can be attractive, particularly for patients at high risk of surgical complications. Modern radiotherapy techniques allow increased treatment conformality, enabling increased radiation dose to the tumour while reducing dose to normal tissue. The objective of this trial is to assess if radiotherapy dose escalation increases the cCR rate, with acceptable toxicity, for treatment of patients with early rectal cancer unsuitable for radical surgery. METHODS AND ANALYSIS: APHRODITE (A Phase II trial of Higher RadiOtherapy Dose In The Eradication of early rectal cancer) is a multicentre, open-label randomised controlled phase II trial aiming to recruit 104 participants from 10 to 12 UK sites. Participants will be allocated with a 2:1 ratio of intervention:control. The intervention is escalated dose radiotherapy (62 Gy to primary tumour, 50.4 Gy to surrounding mesorectum in 28 fractions) using simultaneous integrated boost. The control arm will receive 50.4 Gy to the primary tumour and surrounding mesorectum. Both arms will use intensity-modulated radiotherapy and daily image guidance, combined with concurrent chemotherapy (capecitabine, 5-fluorouracil/leucovorin or omitted). The primary endpoint is the proportion of participants with cCR at 6 months after start of treatment. Secondary outcomes include early and late toxicities, time to stoma formation, overall survival and patient-reported outcomes (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires QLQ-C30 and QLQ-CR29, low anterior resection syndrome (LARS) questionnaire). ETHICS AND DISSEMINATION: The trial obtained ethical approval from North West Greater Manchester East Research Ethics Committee (reference number 19/NW/0565) and is funded by Yorkshire Cancer Research. The final trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors guidelines. TRIAL REGISTRATION NUMBER: ISRCTN16158514.

Impact of communication on first treatment decisions in people with relapsing-remitting multiple sclerosis.

OBJECTIVE: Disease-Modifying Treatments (DMTs) have contributed to a new clinical landscape for people with relapsing-remitting multiple sclerosis (pwRRMS). A challenge for services is how to support DMT decisions with changing clinical evidence, and differing treatment goals. This article investigates how pwRRMS weigh up the pros and cons of DMTs by examining how communication at the point of diagnosis is related to DMT decisions. METHODS: 30 semi-structured interviews with pwRRMS in England were conducted using a theoretical purposive sampling strategy and analysed using the thematic approach to answer: How does communication about RRMS during diagnosis influence decisions about when and which DMT to choose? RESULTS: Three meta-themes were identified: a) communication context; b) delayed communication and hope for people with "non-active" RRMS at diagnosis; c) people with "active" RRMS at diagnosis: Conflated, generic, selective and simplified information CONCLUSION: At the time of diagnosis, patient-physician interactions are characterised by emotions and information complexity. Clinical, social and psychological DMT filtering mechanisms are activated during first decisions. Personalised evidence is needed to make informed decisions. PRACTICE IMPLICATIONS: Patient decision aids should consider first and consecutive decisions and should not encourage a false sense of large choices that could add to decision anxiety.