Patient initiated follow-up in cancer patients: A systematic review

Background Patient-initiated follow-up (PIFU) is increasingly being implemented for oncology patients, particularly during the COVID-19 pandemic, given the necessary reduction in face-to-face hospital outpatient appointments. We do not know if PIFU has a positive (or negative) impact on overall, or progression free, survival. Objectives To investigate the impact of PIFU on overall survival, progression free survival, patient satisfaction, psychological morbidity, specifically quality of life (QoL) and economic costs compared to hospital follow up (HFU), for any type of cancer. Methods We carried out a systematic review using five electronic databases: MEDLINE, CINAHL, EMBASE, PsycInfo and Cochrane Central Register of Controlled Trials. Studies were eligible if they were controlled clinical trials comparing PIFU with another form of active follow-up. Effectiveness was assessed using the primary outcome of overall survival and secondary outcomes of progression free survival, patient satisfaction, psychological morbidity, QoL and cost effectiveness. Results Eight studies met the inclusion criteria and were included. Only one study included survival as a primary outcome and indicated no significant differences between hospital-based follow-up and PIFU, although not adequately powered to detect a difference in survival. For secondary outcomes, few differences were found between PIFU and other forms of active follow-up. One study reported significant differences in fear of cancer recurrence between PIFU and HFU although did not reach the limit of clinical significance;in the short term, fear decreased significantly more in hospital based follow-up. Conclusion We do not have evidence to support the impact of PIFU on survival or progression free survival. Fully powered randomized controlled trials are required to determine the full impact of PIFU in the longer term.

Eligibility screening older research participants using remote cognitive assessment-experiences and reflections from a primary care randomised controlled trial.

BACKGROUND: The COVID-19 pandemic forced many research teams to adjust the way they conduct studies, including moving to remote delivery of some or all of their recruitment and data collection processes. The Montreal Cognitive Assessment (MoCA) is widely used in research and is available in multiple formats for different groups and assessment settings. Here, we reflect on our experiences of administering the MoCA Blind/Telephone as part of the initial telephone eligibility check for participation in a randomised controlled trial with community-dwelling older people with frailty. MAIN BODY: In response to COVID-19, a number of changes were made to the trial's screening and recruitment procedures, to minimise the amount of time the researchers would spend in the participants' homes when recruitment began in May 2021. One of the changes was for the researchers to conduct a cognitive assessment for eligibility during an initial telephone call, rather than during the subsequent home visit for consent and baseline data collection. We found that in comparison with conducting the assessment in-person, telephone administration caused uncertainty for the researchers about whether participants were struggling to answer questions due to cognition or hearing impairment. Some participants experienced practical difficulties when combining holding a telephone and completing one of the assessment items. It was hard for the researchers to judge the emotional impact that undertaking the assessment was having on the older people on the telephone, without visual warning signs of fatigue or mood. We discuss the potential impact of these issues on trial recruitment and participant engagement, and the feasibility of videoconferencing as an alternative method of conducting the MoCA. CONCLUSION: The MoCA is a useful tool when cognitive impairment is part of screening and data collection and it is helpful to have the option to use the test remotely. However, as we have found, telephone testing is not always straightforward. Researchers should weigh up the pros and cons for each individual study, especially those involving older adults. If choosing remote methods, consider the practicality of using videoconferencing and think about the possible impact of telephone assessment on the relationship with the (potential) research participants. TRIAL REGISTRATION: Personalised care planning for older people with frailty ISRCTN16123291 28/08/2020.

Can we mitigate the psychological impacts of social isolation using behavioural activation? Long-term results of the UK BASIL urgent public health COVID-19 pilot randomised controlled trial and living systematic review.

BACKGROUND: Behavioural and cognitive interventions remain credible approaches in addressing loneliness and depression. There was a need to rapidly generate and assimilate trial-based data during COVID-19. OBJECTIVES: We undertook a parallel pilot RCT of behavioural activation (a brief behavioural intervention) for depression and loneliness (Behavioural Activation in Social Isolation, the BASIL-C19 trial ISRCTN94091479). We also assimilate these data in a living systematic review (PROSPERO CRD42021298788) of cognitive and/or behavioural interventions. METHODS: Participants (≥65 years) with long-term conditions were computer randomised to behavioural activation (n=47) versus care as usual (n=49). Primary outcome was PHQ-9. Secondary outcomes included loneliness (De Jong Scale). Data from the BASIL-C19 trial were included in a metanalysis of depression and loneliness. FINDINGS: The 12 months adjusted mean difference for PHQ-9 was -0.70 (95% CI -2.61 to 1.20) and for loneliness was -0.39 (95% CI -1.43 to 0.65).The BASIL-C19 living systematic review (12 trials) found short-term reductions in depression (standardised mean difference (SMD)=-0.31, 95% CI -0.51 to -0.11) and loneliness (SMD=-0.48, 95% CI -0.70 to -0.27). There were few long-term trials, but there was evidence of some benefit (loneliness SMD=-0.20, 95% CI -0.40 to -0.01; depression SMD=-0.20, 95% CI -0.47 to 0.07). DISCUSSION: We delivered a pilot trial of a behavioural intervention targeting loneliness and depression; achieving long-term follow-up. Living meta-analysis provides strong evidence of short-term benefit for loneliness and depression for cognitive and/or behavioural approaches. A fully powered BASIL trial is underway. CLINICAL IMPLICATIONS: Scalable behavioural and cognitive approaches should be considered as population-level strategies for depression and loneliness on the basis of a living systematic review.

Reducing delayed transfer of care in older people: A qualitative study of barriers and facilitators to shorter hospital stays.

INTRODUCTION: Growing numbers of older patients occupy hospital beds despite being 'medically fit' for discharge. These Delayed Transfers of Care amplify inefficiencies in care and can cause harm. Delayed transfer because of family or patient choice is common; yet, research on patient and family perspectives is scarce. To identify barriers to, and facilitators of, shorter hospital stays, we sought to understand older people's and caregivers' thoughts and feelings about the benefits and harms of being in hospital and the decisions made at discharge. METHODS: A multimethod qualitative study was carried out. Content analysis was carried out of older people's experiences of health or care services submitted to the Care Opinion online website, followed by telephone and video interviews with older people and family members of older people experiencing a hospital stay in the previous 12 months. RESULTS: Online accounts provide insight into how care was organized for older people in the hospital, including deficiencies in care organization, the discharge process and communication, as well as how care was experienced by older people and family members. Interview-generated themes included shared meanings of hospitalization and discharge experiences and the context of discharge decisions including failure in communication systems, unwarranted variation and lack of confidence in care and lack of preparation for ongoing care. CONCLUSION: Poor quality and availability of information, and poor communication, inhibit effective transfer of care. Communication is fundamental to patient-centred care and even more important in discharge models characterized by limited assessments and quicker discharge. Interventions at the service level and targeted patient information about what to expect in discharge assessments and after discharge could help to address poor communication and support for improving discharge of older people from hospital. PATIENT OR PUBLIC CONTRIBUTION: The Frailty Oversight Group, a small group of older people providing oversight of the Community Aging Research 75+ study, provided feedback on the research topic and level of interest, the draft data collection tools and the feasibility of collecting data with older people during the COVID-19 pandemic. The group also reviewed preliminary findings and provided feedback on our interpretation.

The accuracy of pulse oximetry in measuring oxygen saturation by levels of skin pigmentation: a systematic review and meta-analysis.

BACKGROUND: During the COVID-19 pandemic, there have been concerns regarding potential bias in pulse oximetry measurements for people with high levels of skin pigmentation. We systematically reviewed the effects of skin pigmentation on the accuracy of oxygen saturation measurement by pulse oximetry (SpO2) compared with the gold standard SaO2 measured by CO-oximetry. METHODS: We searched Ovid MEDLINE, Ovid Embase, EBSCO CINAHL, ClinicalTrials.gov, and WHO International Clinical Trials Registry Platform (up to December 2021) for studies with SpO2-SaO2 comparisons and measuring the impact of skin pigmentation or ethnicity on pulse oximetry accuracy. We performed meta-analyses for mean bias (the primary outcome in this review) and its standard deviations (SDs) across studies included for each subgroup of skin pigmentation and ethnicity and used these pooled mean biases and SDs to calculate accuracy root-mean-square (Arms) and 95% limits of agreement. The review was registered with the Open Science Framework ( https://osf.io/gm7ty ). RESULTS: We included 32 studies (6505 participants): 15 measured skin pigmentation and 22 referred to ethnicity. Compared with standard SaO2 measurement, pulse oximetry probably overestimates oxygen saturation in people with the high level of skin pigmentation (pooled mean bias 1.11%; 95% confidence interval 0.29 to 1.93%) and people described as Black/African American (1.52%; 0.95 to 2.09%) (moderate- and low-certainty evidence). The bias of pulse oximetry measurements for people with other levels of skin pigmentation or those from other ethnic groups is either more uncertain or suggests no overestimation. Whilst the extent of mean bias is small or negligible for all subgroups evaluated, the associated imprecision is unacceptably large (pooled SDs > 1%). When the extent of measurement bias and precision is considered jointly, pulse oximetry measurements for all the subgroups appear acceptably accurate (with Arms < 4%). CONCLUSIONS: Pulse oximetry may overestimate oxygen saturation in people with high levels of skin pigmentation and people whose ethnicity is reported as Black/African American, compared with SaO2. The extent of overestimation may be small in hospital settings but unknown in community settings. REVIEW PROTOCOL REGISTRATION: https://osf.io/gm7ty.

Mortality of Care Home Residents and Community-Dwelling Controls During the COVID-19 Pandemic in 2020: Matched Cohort Study.

OBJECTIVE: This study aimed to estimate and compare mortality of care home residents, and matched community-dwelling controls, during the COVID-19 pandemic from primary care electronic health records in England. DESIGN: Matched cohort study. SETTING AND PARTICIPANTS: Family practices in England in the Clinical Practice Research Datalink Aurum database. There were 83,627 care home residents in 2020, with 26,923 deaths; 80,730 (97%) were matched on age, sex, and family practice with 300,445 community-dwelling adults. METHODS: All-cause mortality was evaluated and adjusted rate ratios by negative binomial regression were adjusted for age, sex, number of long-term conditions, frailty category, region, calendar month or week, and clustering by family practice. RESULTS: Underlying mortality of care home residents was higher than community controls (adjusted rate ratio 5.59, 95% confidence interval 5.23‒5.99, P < .001). During April 2020, there was a net increase in mortality of care home residents over that of controls. The mortality rate of care home residents was 27.2 deaths per 1000 patients per week, compared with 2.31 per 1000 for controls. Excess deaths for care home residents, above that predicted from pre-pandemic years, peaked between April 13 and 19 (men, 27.7, 95% confidence interval 25.1‒30.3; women, 17.4, 15.9‒18.8 per 1000 per week). Compared with care home residents, long-term conditions and frailty were differentially associated with greater mortality in community-dwelling controls. CONCLUSIONS AND IMPLICATIONS: Individual-patient data from primary care electronic health records may be used to estimate mortality in care home residents. Mortality is substantially higher than for community-dwelling comparators and showed a disproportionate increase in the first wave of the COVID-19 pandemic. Care home residents require particular protection during periods of high infectious disease transmission.

Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial.

INTRODUCTION: Depression is a leading mental health problem worldwide. People with long-term conditions are at increased risk of experiencing depression. The COVID-19 pandemic led to strict social restrictions being imposed across the UK population. Social isolation can have negative consequences on the physical and mental wellbeing of older adults. In the Behavioural Activation in Social IsoLation (BASIL+) trial we will test whether a brief psychological intervention (based on Behavioural Activation), delivered remotely, can mitigate depression and loneliness in older adults with long-term conditions during isolation. METHODS: We will conduct a two-arm, parallel-group, randomised controlled trial across several research sites, to evaluate the clinical and cost-effectiveness of the BASIL+ intervention. Participants will be recruited via participating general practices across England and Wales. Participants must be aged ≥65 with two or more long-term conditions, or a condition that may indicate they are within a 'clinically extremely vulnerable' group in relation to COVID-19, and have scored ≥5 on the Patient Health Questionnaire (PHQ9), to be eligible for inclusion. Randomisation will be 1:1, stratified by research site. Intervention participants will receive up to eight intervention sessions delivered remotely by trained BASIL+ Support Workers and supported by a self-help booklet. Control participants will receive usual care, with additional signposting to reputable sources of self-help and information, including advice on keeping mentally and physically well. A qualitative process evaluation will also be undertaken to explore the acceptability of the BASIL+ intervention, as well as barriers and enablers to integrating the intervention into participants' existing health and care support, and the impact of the intervention on participants' mood and general wellbeing in the context of the COVID-19 restrictions. Semi-structured interviews will be conducted with intervention participants, participant's caregivers/supportive others and BASIL+ Support Workers. Outcome data will be collected at one, three, and 12 months post-randomisation. Clinical and cost-effectiveness will be evaluated. The primary outcome is depressive symptoms at the three-month follow up, measured by the PHQ9. Secondary outcomes include loneliness, social isolation, anxiety, quality of life, and a bespoke health services use questionnaire. DISCUSSION: This study is the first large-scale trial evaluating a brief Behavioural Activation intervention in this population, and builds upon the results of a successful external pilot trial. TRIAL REGISTRATION: ClinicalTrials.Gov identifier ISRCTN63034289, registered on 5th February 2021.

The prevalence of mental health conditions in healthcare workers during and after a pandemic: Systematic review and meta-analysis.

AIMS: This review aims to explore the prevalence and incidence rates of mental health conditions in healthcare workers during and after a pandemic outbreak and which factors influence rates. BACKGROUND: Pandemics place considerable burden on care services, impacting on workers' health and their ability to deliver services. We systematically reviewed the prevalence and incidence of mental health conditions in care workers during pandemics. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Searches of MEDLINE, Embase, Cochrane Library and PsychINFO for cohort, cross-sectional and case-control studies were undertaken on the 31 March 2020 (from inception to 31 March 2020). REVIEW METHODS: Only prevalence or incidence rates for mental health conditions from validated tools were included. Study selection, data extraction and quality assessment were carried out by two reviewers. Meta-analyses and subgroup analyses were produced for pandemic period (pre- and post), age, country income, country, clinical setting for major depression disorder (MDD), anxiety disorder and post-traumatic stress disorder (PTSD). RESULTS: No studies of incidence were found. Prevalence estimates showed that the most common mental health condition was PTSD (21.7%) followed by anxiety disorder (16.1%), MDD (13.4%) and acute stress disorder (7.4%) (low risk of bias). For symptoms of these conditions there was substantial variation in the prevalence estimates for depression (95% confidence interval [CI]:31.8%; 60.5%), anxiety (95% CI:34.2%; 57.7%) and PTSD symptoms (95% CI,21.4%; 65.4%) (moderate risk of bias). Age, level of exposure and type of care professional were identified as important moderating factors. CONCLUSION: Mental disorders affect healthcare workers during and after infectious disease pandemics, with higher proportions experiencing symptoms. IMPACT: This review provides prevalence estimates of mental health conditions during and after a pandemic which could be used to inform service staffing impact and formulation of preventative strategies, by identifying clinical populations who may be at high risk of developing mental health symptoms and conditions.

Community Ageing Research 75+ (CARE75+) REMOTE study: a remote model of recruitment and assessment of the health, well-being and social circumstances of older people.

INTRODUCTION: The Community Ageing Research 75+ (CARE75+) study is a longitudinal cohort study collecting extensive health and social data, with a focus on frailty, independence and quality of life in older age. CARE75+ was the first international experimental frailty research cohort designed using trial within cohorts (TwiCs) methodology, aligning epidemiological research with clinical trial evaluation of interventions to improve the health and well-being of older people. CARE75+ REMOTE is an extension of CARE75+ using a remote model that does not require face-to-face interactions for data collection in the current circumstances of a global pandemic and will provide an efficient, sustainable data collection model. METHODS AND ANALYSIS: Prospective cohort study using TwiCs. One thousand community-dwelling older people (≥75 years) will be recruited from UK general practices by telephone. Exclusions include: nursing home/care home residents; those with an estimated life expectancy of 3 months or less; and people receiving palliative care. DATA COLLECTION: Assessments will be conducted by telephone, web-submission or postal questionnaire: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months. Measures include activities of daily living, mood, health-related quality of life, comorbidities, medications, frailty, informal care, healthcare and social care service use. Consent will be sought for data linkage and invitations to additional studies (sub-studies). ETHICS AND DISSEMINATION: CARE75+ was approved by the National Research Ethics Service (NRES) Committee Yorkshire and the Humber-Bradford Leeds 10 October 2014 (14/YH/1120). CARE75+ REMOTE (amendment 13) was approved on the 18th November 2020. Consent is sought if an individual is willing to participate and has capacity to provide informed consent. Consultee assent is sought if an individual lacks capacity. Results will be disseminated in peer-reviewed scientific journals and conferences. Results will be summarised and disseminated to study participants via newsletters, local engagement events and on a bespoke website. TRIAL REGISTRATION NUMBER: ISRCTN16588124.

Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial.

BACKGROUND: Older adults, including those with long-term conditions (LTCs), are vulnerable to social isolation. They are likely to have become more socially isolated during the Coronavirus Disease 2019 (COVID-19) pandemic, often due to advice to "shield" to protect them from infection. This places them at particular risk of depression and loneliness. There is a need for brief scalable psychosocial interventions to mitigate the psychological impacts of social isolation. Behavioural activation (BA) is a credible candidate intervention, but a trial is needed. METHODS AND FINDINGS: We undertook an external pilot parallel randomised trial (ISRCTN94091479) designed to test recruitment, retention and engagement with, and the acceptability and preliminary effects of the intervention. Participants aged ≥65 years with 2 or more LTCs were recruited in primary care and randomised by computer and with concealed allocation between June and October 2020. BA was offered to intervention participants (n = 47), and control participants received usual primary care (n = 49). Assessment of outcome was made blind to treatment allocation. The primary outcome was depression severity (measured using the Patient Health Questionnaire 9 (PHQ-9)). We also measured health-related quality of life (measured by the Short Form (SF)-12v2 mental component scale (MCS) and physical component scale (PCS)), anxiety (measured by the Generalised Anxiety Disorder 7 (GAD-7)), perceived social and emotional loneliness (measured by the De Jong Gierveld Scale: 11-item loneliness scale). Outcome was measured at 1 and 3 months. The mean age of participants was aged 74 years (standard deviation (SD) 5.5) and they were mostly White (n = 92, 95.8%), and approximately two-thirds of the sample were female (n = 59, 61.5%). Remote recruitment was possible, and 45/47 (95.7%) randomised to the intervention completed 1 or more sessions (median 6 sessions) out of 8. A total of 90 (93.8%) completed the 1-month follow-up, and 86 (89.6%) completed the 3-month follow-up, with similar rates for control (1 month: 45/49 and 3 months 44/49) and intervention (1 month: 45/47and 3 months: 42/47) follow-up. Between-group comparisons were made using a confidence interval (CI) approach, and by adjusting for the covariate of interest at baseline. At 1 month (the primary clinical outcome point), the median number of completed sessions for people receiving the BA intervention was 3, and almost all participants were still receiving the BA intervention. The between-group comparison for the primary clinical outcome at 1 month was an adjusted between-group mean difference of -0.50 PHQ-9 points (95% CI -2.01 to 1.01), but only a small number of participants had completed the intervention at this point. At 3 months, the PHQ-9 adjusted mean difference (AMD) was 0.19 (95% CI -1.36 to 1.75). When we examined loneliness, the adjusted between-group difference in the De Jong Gierveld Loneliness Scale at 1 month was 0.28 (95% CI -0.51 to 1.06) and at 3 months -0.87 (95% CI -1.56 to -0.18), suggesting evidence of benefit of the intervention at this time point. For anxiety, the GAD adjusted between-group difference at 1 month was 0.20 (-1.33, 1.73) and at 3 months 0.31 (-1.08, 1.70). For the SF-12 (physical component score), the adjusted between-group difference at 1 month was 0.34 (-4.17, 4.85) and at 3 months 0.11 (-4.46, 4.67). For the SF-12 (mental component score), the adjusted between-group difference at 1 month was 1.91 (-2.64, 5.15) and at 3 months 1.26 (-2.64, 5.15). Participants who withdrew had minimal depressive symptoms at entry. There were no adverse events. The Behavioural Activation in Social Isolation (BASIL) study had 2 main limitations. First, we found that the intervention was still being delivered at the prespecified primary outcome point, and this fed into the design of the main trial where a primary outcome of 3 months is now collected. Second, this was a pilot trial and was not designed to test between-group differences with high levels of statistical power. Type 2 errors are likely to have occurred, and a larger trial is now underway to test for robust effects and replicate signals of effectiveness in important secondary outcomes such as loneliness. CONCLUSIONS: In this study, we observed that BA is a credible intervention to mitigate the psychological impacts of COVID-19 isolation for older adults. We demonstrated that it is feasible to undertake a trial of BA. The intervention can be delivered remotely and at scale, but should be reserved for older adults with evidence of depressive symptoms. The significant reduction in loneliness is unlikely to be a chance finding, and replication will be explored in a fully powered randomised controlled trial (RCT). TRIAL REGISTRATION: ISRCTN94091479.

Life in lockdown: a telephone survey to investigate the impact of COVID-19 lockdown measures on the lives of older people (≥75 years).

BACKGROUND: In response to the coronavirus disease 2019 (COVID-19) pandemic, the UK government introduced social distancing measures and identified specific populations at high risk from the virus. People ≥70 were deemed 'Clinically Vulnerable'. Distancing measures were introduced to reduce the risk of contracting COVID-19. However, these may have a negative impact on older people who are vulnerable to social isolation and may have challenges accessing services and provisions. OBJECTIVES: To investigate the impact of COVID-19 lockdown measures on the lives of older people. STUDY DESIGN AND SETTING: Cross-sectional telephone survey. PARTICIPANTS: Community-dwelling older people, 76-97 years. OUTCOMES: Health anxiety; General health (RAND Short-form 36 Survey); Physical activity; Depression (PHQ-8); Anxiety (GAD-2); Loneliness; Access to services; Challenges, concerns and positive experiences. DATA ANALYSIS: Counts (%), means (SDs). Thematic analysis was used to identify themes from open questions. RESULTS: n = 142. 52% did not worry about their health; 76% rated their health as 'good', 'very good' or 'excellent'; <10% met the criteria indicative of depression (PHQ-8), or anxiety (GAD-2); 42% were less active than before lockdown; and 27% were lonely at least some of the time. Over half of participants identified positive aspects. CONCLUSIONS: Most participants reported good health with low levels of health anxiety, anxiety and depression. Many were able to identify positive aspects to lockdown and may be better equipped to deal with lockdown than anticipated. Strategies may be required to ameliorate the negative impact of loneliness for a minority of older people, and help some resume previous activity levels and pursuits.