Systematic review of caregiver burden, unmet needs and quality-of-life among informal caregivers of patients with pancreatic cancer.

PURPOSE: Informal caregivers play an important supportive care role for patients with cancer. This may be especially true for pancreatic cancer which is often diagnosed late, has a poor prognosis and is associated with a significant symptom burden. We systematically reviewed the evidence on caregiver burden, unmet needs and quality-of-life of informal caregivers to patients with pancreatic cancer. METHOD: PubMed, Medline, CINAHL and Embase databases were systematically searched on 31 August 2021. Qualitative and quantitative data on informal caregivers' experiences were extracted and coded into themes of burden, unmet needs or quality-of-life with narrative synthesis of the data undertaken. RESULTS: Nine studies (five qualitative, four quantitative), including 6023 informal caregivers, were included in the review. We categorised data into three key themes: caregiver burden, unmet needs and quality-of-life. Data on caregiver burden was organised into a single subtheme relating to symptom management as a source of burden. Data on unmet needs was organised into three subthemes need for: better clinical communication; support and briefings for caregivers; and help with navigating the health care system. Data on quality-of-life indicate large proportions of informal caregivers experience clinical levels of anxiety (33%) or depression (12%-32%). All five qualitative studies were graded as good quality; three quantitative studies were poor quality, and one was fair quality. CONCLUSION: High-quality pancreatic cancer care should consider the impacts of informal caregiving. Prospective longitudinal studies examining multiple dimensions of caregiver burden, needs, and quality-of-life would be valuable at informing supportive care cancer delivery to pancreatic cancer informal caregivers.

Parental responsibility for pediatric ventricular assist devices: Views of families on the acceptability of hospital discharge.

BACKGROUND: Paracorporeal pediatric VAD therapy requires hospital residency due to device and patient factors. Discharge home is potentially possible with a mobile driving unit. This study aimed to investigate family views on hospital discharge of a child on VAD. METHODS: Qualitative methodologies were adopted. We undertook 24 interviews of families who had a transplanted child previously on a VAD, and participant observations of two families who were current VAD patients residing in hospital. RESULTS: Families experienced overwhelming emotions as they spent time adjusting to the diagnosis, the need for transplant, family separation, and financial concerns. Despite many parents being partially/fully trained on the VAD, the majority would be reluctant to be discharged, fearing emergencies, high burden of care needs, and social isolation. Three families with a child on a Berlin Heart expressed willingness to reside in the hospital accommodation at least part-time, to facilitate private family time. One child on HeartWare was discharged home, with another going through the discharge process. Discharge was not acceptable to most families if this meant downgrading their child's transplant listing urgency status. CONCLUSION: Parents and children on VAD value independence and some private family time but not at the perceived expense of safety. Families preferred their child on VAD to remain resident in hospital even if mobility is improved with a mobile driving device. Parental education should acknowledge the high burden on families, risks of a remote setting and offer intermediate residency options. It cannot be assumed families want hospital discharge.

Alcohol Screening and Brief Intervention in Police Custody Suites: Pilot Cluster Randomised Controlled Trial (AcCePT).

AIMS: There is a clear association between alcohol use and offending behaviour and significant police time is spent on alcohol-related incidents. This study aimed to test the feasibility of a trial of screening and brief intervention in police custody suites to reduce heavy drinking and re-offending behaviour. SHORT SUMMARY: We achieved target recruitment and high brief intervention delivery if this occurred immediately after screening. Low rates of return for counselling and retention at follow-up were challenges for a definitive trial. Conversely, high consent rates for access to police data suggested at least some outcomes could be measured remotely. METHODS: A three-armed pilot Cluster Randomised Controlled Trial with an embedded qualitative interview-based process evaluation to explore acceptability issues in six police custody suites (north east and south west of the UK). Interventions included: 1. Screening only (Controls), 2. 10 min Brief Advice 3. Brief Advice plus 20 min of brief Counselling. RESULTS: Of 3330 arrestees approached: 2228 were eligible for screening (67%) and 720 consented (32%); 386 (54%) scored 8+ on AUDIT; and 205 (53%) were enroled (79 controls, 65 brief advice and 61 brief counselling). Follow-up rates at 6 and 12 months were 29% and 26%, respectively. However, routinely collected re-offending data were obtained for 193 (94%) participants. Indices of deprivation data were calculated for 184 (90%) participants; 37.6% of these resided in the 20% most deprived areas of UK. Qualitative data showed that all arrestees reported awareness that participation was voluntary, that the trial was separate from police work, and the majority said trial procedures were acceptable. CONCLUSION: Despite hitting target recruitment and same-day brief intervention delivery, a future trial of alcohol screening and brief intervention in a police custody setting would only be feasible if routinely collected re-offending and health data were used for outcome measurement. TRIAL REGISTRATION: ISRCTN number: 89291046.

The Gestational Obesity Weight Management: Implementation of National Guidelines (GLOWING) study: a pilot cluster randomised controlled trial.

BACKGROUND: Pregnancy weight management interventions can improve maternal diet, physical activity, gestational weight gain, and postnatal weight retention. UK guidelines were published in 2010 but health professionals report multiple complex barriers to practice. GLOWING used social cognitive theory to address evidence-based barriers to midwives' implementation of weight management guidelines into routine practice. This paper reports the pilot trial outcomes relating to feasibility and acceptability of intervention delivery and trial procedures. METHODS: GLOWING was a multi-centre parallel-group pilot cluster RCT comparing the delivery of a behaviour change intervention for midwives (delivered as training workshops) with usual practice. The clusters were four NHS Trusts in Northeast England, randomised to intervention or control arms. Blinding of allocation was not possible due to the nature of the intervention. We aimed to deliver the intervention to all eligible midwives in the intervention arm, in groups of 6 midwives per workshop, and to pilot questionnaire data collection for a future definitive trial. Intervention arm midwives' acceptability of GLOWING content and delivery was assessed using a mixed methods questionnaire, and pregnant women's acceptability of trial procedures by interviews. Quantitative data were analysed descriptively and qualitative data thematically. RESULTS: In intervention arm Trusts, 100% of eligible midwives (n = 67) were recruited to, and received, the intervention; however, not all workshops had the planned number of attendees (range 3-8). The consent rate amongst midwives randomised (n = 100) to complete questionnaires was 74% (n = 74) (95% CI 65%, 83%), and overall completion rate 89% (n = 66) (95% CI 82%, 96%). Follow-up response rate was 66% (n = 49) (95% CI 55%, 77%), with a marked difference between intervention (39%, n = 15) and control (94%, n = 34) groups potentially due to the volume of research activities. Overall, 64% (n = 47) (95% CI 53%, 75%) completed both baseline and follow-up questionnaires. Midwives viewed the intervention as acceptable and directly relevant to routine practice. The least popular components related to scripted role-plays. Pregnant women viewed the recruitment and trial processes to be acceptable. CONCLUSIONS: This rigorously conducted pilot study demonstrated feasibility intervention delivery and a high level of acceptability amongst participants. It has provided information required to refine the intervention and trial protocol, enhancing confidence that a definitive trial could be carried out. TRIAL REGISTRATION: ISRCTN46869894; retrospectively registered 25th May 2016, www.isrctn.com/ISRCTN46869894 .

Assessing the unmet needs of patients with advanced cancer treated by biological and precision therapies: protocol for TARGET, a mixed methods study.

INTRODUCTION: Biological and precision therapies are increasingly used in cancer treatment. Although they may improve survival, they are also associated with various-and unique-adverse effects, which can be long lasting. Little is known about the experiences of people treated with these therapies. Moreover, their supportive care needs have not been fully explored. Consequently, it is unclear whether existing instruments adequately capture the unmet needs of these patients. The TARGET study seeks to address these evidence gaps by exploring the needs of people treated with these therapies with the aim of developing an unmet needs assessment instrument for patients on biological and precision therapies. METHODS AND ANALYSIS: The TARGET study will adopt a multi-methods design involving four Workstreams (1) a systematic review to identify, describe and assess existing unmet needs instruments in advanced cancer; (2) qualitative interviews with patients on biological and precision therapies, and their healthcare professionals, to explore experiences and care needs; (3) development and piloting of a new (or adapted) unmet needs questionnaire (based on the findings of Workstream 1 and Workstream 2) designed to capture the supportive care needs of these patients; and finally, (4) a large-scale patient survey using the new (or modified) questionnaire to determine (a) the psychometric properties of the questionnaire, and (b) the prevalence of unmet needs in these patients. Based on the broad activity of biological and precision therapies, the following cancers will be included: breast, lung, ovarian, colorectal, renal and malignant melanoma. ETHICS AND DISSEMINATION: This study was approved by National Health Service (NHS) Heath Research Authority Northeast Tyne and Wear South Research Ethics Committee (REC ref: 21/NE/0028). Dissemination of the research findings will take several formats to reach different audiences, including patients, healthcare professionals and researchers.

Assessing unmet needs in advanced cancer patients: a systematic review of the development, content, and quality of available instruments.

PURPOSE: Advances in treatment, including biological and precision therapies, mean that more people are living with advanced cancer. Supportive care needs likely change across the cancer journey. We systematically identified instruments available to assess unmet needs of advanced cancer patients and evaluated their development, content, and quality. METHODS: Systematic searches of MEDLINE, CINAHL, Embase, PubMed, and PsycINFO were performed from inception to 11 January 2021. Independent reviewers screened for eligibility. Data was abstracted on instrument characteristics, development, and content. Quality appraisal included methodological and quality assessment, GRADE, feasibility, and interpretability, following consensus-based standards for the selection of health measurement instruments (COSMIN) guidelines. RESULTS: Thirty studies reporting 24 instruments were identified. These were developed for general palliative patients (n = 2 instruments), advanced cancer (n = 8), and cancer irrespective of stage (n = 14). None focused on patients using biological or precision therapies. The most common item generation and reduction techniques were amending an existing instrument (n = 11 instruments) and factor analysis (n = 8), respectively. All instruments mapped to ≥ 5 of 11 unmet need dimensions, with Problems and Needs in Palliative Care (PNPC) and Psychosocial Needs Inventory (PNI) covering all 11. No instrument reported all of the COSMIN measurement properties, and methodological quality was variable. CONCLUSIONS: Many instruments are available to assess unmet needs in advanced cancer. There is extensive heterogeneity in their development, content, and quality. IMPLICATIONS FOR CANCER SURVIVORS: Given the growth of precision and biological therapies, research needs to explore how these instruments perform in capturing the needs of people using such therapies.

Association between maternal adiposity measures and adverse maternal outcomes of pregnancy: Systematic review and meta-analysis.

Maternal obesity increases pregnancy-related risks. Women with a body mass index (BMI) ≥ 30 kg/m2 are considered to be at risk and should receive additional care, although approximately half will have uncomplicated pregnancies. This systematic review aimed to identify early pregnancy measures of adiposity associated with adverse maternal health outcomes. Searches included six databases, reference lists, citations, and contacting authors. Screening and quality assessment were carried out by two authors independently. Random effects meta-analysis and narrative synthesis were conducted. Seventy studies were included with a pooled sample of 89,588 women. Meta-analysis showed significantly increased odds of gestational diabetes mellitus (GDM) with higher waist circumference (WC) categories (1.40, 95% confidence interval [CI] 1.04, 1.88) and per unit increase in WC (1.31, 95% CI 1.03, 1.67). Women with GDM had higher WC than controls (mean difference [MD] 6.18 cm, 95% CI 3.92, 8.44). WC was significantly associated with hypertensive disorders, delivery-related outcomes, metabolic syndrome, and composite pregnancy outcomes. Waist to hip ratio was significantly associated with GDM, hypertensive disorders, and delivery-related outcomes. Fat mass, neck circumference, skinfolds, and visceral fat were significantly associated with adverse outcomes, although limited data were available. Our findings identify the need to explore how useful adiposity measures are at predicting risk in pregnancy, compared with BMI, to direct care to women with the greatest need.

Association between maternal adiposity measures and infant health outcomes: A systematic review and meta-analysis.

Maternal obesity increases risks of adverse fetal and infant outcomes. Guidelines use body mass index to diagnose maternal obesity. Evidence suggests body fat distribution might better predict individual risk, but there is a lack of robust evidence during pregnancy. We explored associations between maternal adiposity and infant health. Searches included six databases, references, citations, and contacting authors. Screening and quality assessment were carried out by two authors independently. Random effects meta-analysis and narrative synthesis were conducted. We included 34 studies (n = 40,143 pregnancies). Meta-analysis showed a significant association between maternal fat-free mass and birthweight (average effect [AE] 18.07 g, 95%CI 12.75, 23.38) but not fat mass (AE 8.76 g, 95%CI -4.84, 22.36). Women with macrosomic infants had higher waist circumference than controls (mean difference 4.93 cm, 95% confidence interval [CI] 1.05, 8.82). There was no significant association between subcutaneous fat and large for gestational age (odds ratio 1.06 95% CI 0.91, 1.25). Waist-to-hip ratio, neck circumference, skinfolds, and visceral fat were significantly associated with several infant outcomes including small for gestational age, preterm delivery, neonatal morbidity, and mortality, although meta-analysis was not possible for these variables. Our findings suggest that some measures of maternal adiposity may be useful for risk prediction of infant outcomes. Individual participant data meta-analysis could overcome some limitations in our ability to pool published data.

Negotiating acceptable termination of pregnancy for non-lethal fetal anomaly: a qualitative study of professional perspectives.

OBJECTIVE: This study aims to explore the perspectives of professionals around the issue of termination of pregnancy for non-lethal fetal anomaly (TOPFA). METHODS: Semi-structured interviews were undertaken with medical professionals (14 consultants in fetal medicine, obstetrics, neonatology and paediatrics) and social care professionals (nine individuals with roles supporting people living with impairment) from the Northeast of England. Analysis adopted an inductive thematic approach facilitated by NVivo. RESULTS: The overarching theme to emerge from the interview data was of professionals, medical and social care, wanting to present an acceptable self-image of their views on TOPFA. Professionals' values on 'fixing', pain and 'normality' influenced what aspects of moral acceptability they gave priority to in terms of their standpoint and, in turn, their conceptualisations of acceptable TOPFA. Thus, if a termination could be defended morally, including negotiation of several key issues (including 'fixing', perceptions of pain and normality), then participants conceptualised TOPFA as an acceptable pregnancy outcome. CONCLUSION: Despite different professional experiences, these professional groups were able to negotiate their way through difficult terrain to conceptualise TOPFA as a morally acceptable principle. While professionals have different moral thresholds, no one argued for a restriction of the current legislation. The data suggest that social care professionals also look at the wider social context of a person with an impairment when discussing their views regarding TOPFA. Medical professionals focus more on the individual impairment when discussing their views on TOPFA.

A survey of health professionals' views on acceptable gestational age and termination of pregnancy for fetal anomaly.

Termination of pregnancy for fetal anomaly is legal in the UK with no upper limit, if two doctors, in good faith, agree "there is a substantial risk that if the child were born it would suffer from such physical or mental abnormalities as to be seriously handicapped". This is Clause E of the Human Fertlisation and Embryology Act. The most commonly sighted Clause is C, which states "the pregnancy has not exceeded its twenty-fourth week and that the continuance of the pregnancy would involve risk, greater than if the pregnancy were terminated, of injury to the physical or mental health of the pregnant woman". This study aimed to investigate health professionals' views on gestational age and acceptable termination of pregnancy for fetal anomaly (TOPFA). We undertook a questionnaire survey of UK health professionals working in fetal medicine, obstetrics and gynaecology and neonatology. A study pack consisting of a self-completion questionnaire, an invitation letter, participant information sheet, and a stamped addressed return envelope, were sent to health professionals. We used four fetal anomalies as case study examples in the questionnaire: isolated cleft lip, hypoplastic left heart, spina bifida and trisomy 21. These anomalies were chosen as they differed in terms of the type of anomaly, the type of impairment, and the perceived severity. Forty-one study packs were returned. For anomalies deemed less serious, later gestational ages were an important consideration when deciding acceptable TOPFA. The prognosis of an anomaly was considered an important factor in deciding whether a TOPFA was acceptable alongside gestational age. Clause C of the current UK legislation, which allows a legal termination prior to 24 weeks gestational age if continuing with the pregnancy would impact the mental health of the mother, was deemed a reasonable option for termination when parents are requesting a TOPFA. For each case study example, health professionals responded that TOPFA at '25 weeks and over' was acceptable (cleft lip n = 1; hypoplastic left heart n = 19; spina bifida n = 13 and Trisomy 21 n = 10). Professionals also distinguished between their personal and professional views. These findings offer new insight into how gestational age considerations influence professionals' conceptualisation of acceptable TOPFA.

Interventions to change maternity healthcare professionals' behaviours to promote weight-related support for obese pregnant women: a systematic review.

BACKGROUND: There has been a rapid increase in the publication of guidelines for managing obesity and weight gain during pregnancy over the past five years. Healthcare professionals have identified multiple barriers to this area of practice, including the need to improve their communication skills, beliefs that pregnant women will have negative reactions to weight-related discussions, and a lack of weight management knowledge. This systematic review aimed to identify: the effectiveness of interventions in changing healthcare professionals' practice relating to maternal obesity or weight management during pregnancy; and which behaviour change techniques and modes of intervention delivery have been used in interventions to date. FINDINGS: The search strategy included searching electronic databases, trial registers, and citation searching. Inclusion criteria were intervention studies targeted towards changing healthcare professionals' practice in relation to maternal obesity or weight management. The searches identified 3,608 studies. However, no eligible completed studies were identified. One registered Canadian randomised controlled trial was identified. The trial includes a training intervention for family physicians with the aim of supporting adherence to gestational weight gain guidelines. The trial had not yet commenced therefore no effectiveness data were available. CONCLUSIONS: The current focus of maternal obesity and weight management research is targeted towards changing pregnant women's behaviours. These interventions do not address the multiple healthcare professionals' barriers to maternal obesity and weight management practice. Further research is required to identify the most effective approaches to support healthcare professionals to implement maternal obesity and weight management guidelines into practice.