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The Centre for Evidence-Based Medicine (CEBM) at Oxford University develops, promotes and disseminates better evidence for health care.
Enhancing the trustworthiness of pain research: A call to action.
The personal, social and economic burden of chronic pain is enormous. Tremendous research efforts are being directed toward understanding, preventing, and managing chronic pain. Yet patients with chronic pain, clinicians and the public are sometimes poorly served by an evidence architecture that contains multiple structural weaknesses. These include incomplete research governance, a lack of diversity and inclusivity, inadequate stakeholder engagement, poor methodological rigour and incomplete reporting, a lack of data accessibility and transparency, and a failure to communicate findings with appropriate balance. These issues span pre-clinical research, clinical trials and systematic reviews and impact the development of clinical guidance and practice. Research misconduct and inauthentic data present a further critical risk. Combined, they increase uncertainty in this highly challenging area of study and practice, drive the provision of low value care, increase costs and impede the discovery of more effective solutions. In this focus article, we explore how we can increase trust in pain science, by examining critical challenges using contemporary examples, and describe a novel integrated conceptual framework for enhancing the trustworthiness of pain science. We end with a call for collective action to address this critical issue. Perspective: Multiple challenges can adversely impact the trustworthiness of pain research and health research more broadly. We present ENTRUST-PE, a novel, integrated framework for more trustworthy pain research with recommendations for all stakeholders in the research ecosystem, and make a call to action to the pain research community.
Oro-faecal transmission of SARS-CoV-2: A systematic review of studies employing viral culture from gastrointestinal and other potential oro-faecal sources and evidence for transmission to humans
The extent to which the oro-faecal route contributes to the transmission of SARS-CoV-2 is not established. We systematically reviewed the evidence on the presence of infectious SARS-CoV-2 in faeces and other gastrointestinal sources by examining studies that used viral culture to investigate the presence of replication-competent virus in these samples. We conducted searches in the WHO COVID-19 Database, LitCovid, medRxiv, and Google Scholar for SARS-CoV-2 using keywords and associated synonyms, with a search date up to 28 November 2023. We included 13 studies involving 229 COVID-19 subjects-providing 308 faecal or rectal swab SARS-CoV2 reverse transcription-polymerase chain reaction (RT-PCR)-positive samples tested with viral culture. The methods used for viral culture across the studies were heterogeneous. Three studies (two cohorts and one case series) reported observing replication-competent SARS-CoV-2 confirmed by quantitative RT-PCR (qPCR) and whole-genome sequencing, and qPCR including appropriate cycle threshold changes. Overall, six (1.9%) of 308 faecal samples subjected to cell culture showed replication-competent virus. One study found replication-competent samples from one immunocompromised patient. No studies were identified demonstrating direct evidence of oro-faecal transmission to humans. Our review found a relatively low frequency of replication-competent SARS-CoV-2 in faecal and other gastrointestinal sources. Although it is biologically plausible, more research is needed using standardized cell culture methods, control groups, adequate follow-up, and robust epidemiologic methods, including whether secondary infections occurred, to determine the role of the oro-faecal route in the transmission of SARS-CoV-2.
Effect of the National Enhanced Service for weight management on the content of annual review consultations for patients living with obesity and hypertension and/or diabetes
Guidelines specify that clinicians should support patients living with obesity by referring to weight management programmes (WMPs), but clinicians do so infrequently. To provide additional support to patients living with obesity and weight-related conditions, the UK government instated the National Enhanced Service (NES) for weight management in England, including a reimbursement to general practices for referring eligible patients to WMPs. To assess the impact of the NES on conversations regarding weight and relevant behavioural risk factors in primary care consultations we recruited 11 medical practices in England where the NES was operating and six comparator practices from Scotland and Wales where the NES was not implemented. Clinicians audio-recorded annual review appointments of patients living with obesity and hypertension and/or diabetes. The content of these consultations was synthesised using quantitative content analysis. Consultations with 92 patients were analysed: 58 in England and 34 in Scotland and Wales. No difference was found between the NES sites (England) and non-NES sites (Scotland and Wales) in the proportion of referrals made to WMPs. Clinicians in England weighed patients and took other body measurements more often, mentioned body mass index more often, and had more detailed discussions about patients' diets, but there was no evidence that they differed in their discussion of WMPs or other modifiable risk factors. We found no strong evidence that the NES affected how clinicians addressed weight management or related behavioural risk factors within annual review consultations for patients living with obesity and hypertension and/or diabetes.
The need for translational bioethics within perinatal healthcare and policy making: A COVID-19 case study
The COVID-19 pandemic highlighted many issues that can occur due to lack of translation between the spheres of bioethics and clinical practice. In this paper, we examine how mothers and newborn infants were inappropriately separated during the initial stages of the pandemic due to inconsistent application of ethical principles in determining policy. One of the significant challenges that translational bioethics face is the complexity regarding its implementation into the health service environment. As outlined in the literature, it may be postulated that responsibility for translating bioethics from philosophical concepts into practice is the duty of those training in philosophical theory and reasoning. However, the use of bioethics in informing clinical practice is not just the case of needing a translator but rather requires an interpreter in the widest sense: professionals attuned to both bioethics and clinical practice, who can communicate with both groups effectively. A two-way dialogue needs to be more cohesively established to ensure clinical practice is guided by ethical principles and to focus academic debate towards the pragmatic issues that require ethical exploration. Utilising the translational bioethics model described by Bærøe and applying it to our perinatal COVID case study, we examine how an integrated translational bioethics approach could have prevented the harm and disruption to mother–infant dyads during the initial phase of the pandemic in 2020.
Validity and timeliness of cancer diagnosis data collected during a prospective cohort study and reported by the English and Welsh cancer registries: a retrospective, comparative analysis
Background: Cancer places a high burden on society and health-care systems. Cancer research requires high-quality data, which is resource-intensive to obtain. Using administrative datasets such as cancer registries could improve the efficiency of cancer studies if data were valid and timely. We aimed to compare the validity and timeliness of diagnostic cancer data on-site during the SYMPLIFY study to that obtained from the cancer registries of England and Wales. Methods: Cancer data were collected from 5461 participants across 44 hospital sites during a prospective observational study in England and Wales, SYMPLIFY (ISRCTN10226380). Linked cancer data were obtained from Digital Health and Care Wales (DHCW), the Welsh Cancer Intelligence and Surveillance Unit (WCISU), and the English National Cancer Registration Dataset (NCRD) and Rapid Cancer Registration Dataset (RCRD), regularly between April, 2022, and September, 2023. The primary objectives of the study were to evaluate the validity (via assessment of the proportion of completed data fields and concordance with SYMPLIFY sites), and timeliness of the data in all datasets, for all cancers diagnosed within 9 months of study enrolment. Data fields investigated were cancer site via International Classification of Disease, 10th Revision (ICD-10) code; cancer morphology via International Classification of Diseases for Oncology, 3rd Edition (ICD-O-3) morphology histology code and broad morphological grouping; overall stage; and TNM classification. Findings: For data collected between April, 2022, and September, 2023, completeness at the last data cut available for each dataset ranged from 84% to 100% for ICD-O-3 morphology, from 43% to 100% for overall stage, and from 74% to 83% for TNM stage. The concordance between SYMPLIFY data and NCRD was 96% (95% CI 92–98) for ICD-10, 60% (53–66) for ICD-O-3 morphology, 83% (78–88) for ICD-O-3 broad morphology groupings, 73% (67–78) for stage, and 51% (44–59) for TNM; and with WCISU was 89% (95% CI 81–94) for ICD-10, 63% (53–73) for ICD-O-3 morphology, 80% (70–87) for ICD-O-3 broad morphology groupings, 83% (74–90) for overall stage, and 49% (38–61) for TNM stage. Concordance between SYMPLIFY and RCRD was 95% (95% CI 92–98) for ICD-10, 67% (60–74) for ICD-O-3 morphology, 85% (79–90) for ICD-O-3 broad morphology groupings, and 73% (65–80) for overall stage; and between SYMPLIFY and DHCW was 96% (91–99) for ICD-10, 74% (64–83) for ICD-O-3 morphology, 84% (75–91) for ICD-O-3 broad morphology groupings, and 87% (74–95) for stage. The SYMPLIFY dataset reached completion at 12 months post-enrolment in November, 2022, compared with 13 months for NCRD in December, 2023. RCRD and DHCW reached completion at 13 months and 15 months post-enrolment, in December, 2022, and February, 2023, respectively. Interpretation: We report similar completeness of data fields, concordance, and timeliness between on-site and centrally collected cancer outcomes data. Our findings suggest that central registry data can help alleviate the resource burden in clinical trials and improve cancer research. Cancer registries might need additional resources to provide data for registry-based trials at scale. Funding: GRAIL Bio UK.
Building common understanding: seeking consensus and defining social prescribing across contexts - a collective commentary on a Delphi study
Social prescribing has become a global phenomenon. A Delphi study was recently conducted with 48 social prescribing experts from 26 countries to establish global agreement on the definition of social prescribing. We reflect on the use and utility of the outputs of this work, and where we go from here.
Risk of repeat self-harm among individuals presenting to healthcare services: development and validation of a clinical risk assessment model (OxSET)
BACKGROUND: A self-harm episode is a major risk factor for repeat self-harm. Existing tools to assess and predict repeat self-harm have major methodological limitations, and few are externally validated. OBJECTIVE: To develop and validate a risk assessment model of repeat self-harm up to 6 months after an episode of non-fatal self-harm that resulted in an emergency visit to hospital or specialised care. METHODS: Using Swedish national registers, we identified 53 172 people aged≥10 years who self-harmed during 2008-2012. We allocated 37 523 individuals to development (2820 or 7.5% repeat self-harm incidents within 6 months) and 15 649 to geographic validation (1373 repeat episodes) samples, based on region of residence. In a temporal validation of people who self-harmed during 2018-2019, we identified 25 036 individuals (2886 repeat episodes). We fitted a multivariable accelerated failure time model to predict risk of repeat self-harm. FINDINGS: In the external validations (n=40 685), rates of repeat self-harm were 8.8%-11.5% over 6 months. The final model retained 17 factors. Calibration and discrimination were similar in both validation samples, with observed-to-expected ratio=1.15 (95% CI=1.09 to 1.21) and c-statistic=0.72 (95% CI=0.70 to 0.73) in the geographical validation. At 6 months and a 10% risk cut-off, sensitivity was 51.5% (95% CI=48.8% to 54.2%) and specificity was 80.7% (95% CI=80.1% to 81.4%) in geographic validation; corresponding values were 56.9% (95% CI=55.1% to 58.7%) and 76.0% (95% CI=75.5% to 76.6%) in temporal validation. Discrimination was slightly worse at the 1-month prediction horizon (c-statistics of 0.66-0.68). CONCLUSIONS: Using mostly routinely collected data, simple risk assessment models and tools can provide acceptable levels of accuracy for repeat of self-harm. CLINICAL IMPLICATIONS: This risk model (OXford SElf-harm repeat tool) may assist clinical decision-making.
Diagnostic accuracy of point-of-care lung ultrasound for community-acquired pneumonia in children in ambulatory settings: A systematic review and meta-analysis
Introduction: To perform a systematic review of the diagnostic accuracy of point-of-care lung ultrasound, compared to chest radiography, in children and young people (0–21 years) who present to ambulatory settings with suspected community-acquired pneumonia. Methods: Registration: Prospero June 2021 CRD42021260552. Electronic searching performed on Medline, Embase, CINAHL and Science Citation Index from inception to 20 June 2023. Two researchers independently screened titles, abstracts, and full texts for study selection. Risk of bias was assessed using the Quality Assessment Tool for Diagnostic Accuracy Studies (QUADAS-2) tool. Meta-analysis of included studies. Results: The six studies included in this systematic review described point-of-care lung ultrasound performed primarily by paediatric emergency medicine clinicians on a total of 1099 paediatric patients, with a reference standard of chest radiography or chest radiography with clinical findings. The majority of included studies lacked clarity on training for the index test with potential bias around flow and timing of testing. Meta-analysis of the combined results of the included six studies calculated a pooled sensitivity of 90.9% (95% CI [85.5%, 94.4%]) and pooled specificity of 80.7% (95% CI [63.6%, 91.0%]). Conclusions: Point-of-care lung ultrasound has high sensitivity but lower specificity to diagnose acute pneumonia in children. Further research is needed which overcomes issues around training in point-of-care lung ultrasound, study design and reliability of the reference test (chest radiography) to better evidence the role of point-of-care lung ultrasound in diagnosing pneumonia in children in ambulatory and resource-limited settings.
Fitting in or belonging: emerging findings from a realist evaluation of social prescribing link workers in primary care
BACKGROUND: Social prescribing link workers are being employed in primary care through the Additional Roles Reimbursement Scheme. AIM: To understand and explain how the link worker role is being implemented and sustained in primary care. METHOD: As part of a realist evaluation, we observed link workers in practices in different parts of England and interviewed patients and professionals. Data have been coded and are being developed into statements that explain how context interacts with mechanisms leading to intended and unintended outcomes. RESULTS: Our first work package (WP) involved data collection from seven sites in England. For this WP, we interviewed 61 patients and 94 professionals (link workers, GPs, and members of the voluntary-community sector). 'Boundaries' is a key concept within the data. It can describe whether and how link workers draw limits around their role. This can affect the breadth of their work, as they attempt to gain credibility and acceptance within a practice. Boundaries can shape how far link workers feel they belong rather than having to fit into a practice. This may shape their ability to support patients with their psychosocial needs. CONCLUSION: Dominance of a medical model approach to service delivery may not be conducive to uncovering and supporting people with their non-medical problems, or to promoting a wider understanding of health. Tensions between fitting into a setting dominated by medical discourse and practices, compared to feeling they belong, is something that link workers can encounter when providing social prescribing services in primary care.
Patient buy-in to social prescribing through link workers as part of person-centred care: a realist evaluation.
BACKGROUND: Social prescribing link workers have become part of primary health care in recent years. They help patients to recognise non-medical factors affecting their health and identify sources of support, often in the voluntary, community and social enterprise sector. They form part of wider work to strengthen person-centred care, which actively seeks to engage individuals in decision-making about their health, taking into account their medical, social, psychological, financial and spiritual circumstances. OBJECTIVE: To understand how buy-in to social prescribing and the link worker role is established for a patient, and how this relates to person-centred care. DESIGN: A realist evaluation. SETTING: Patients engaging with link workers in seven different parts of England were involved. METHODS: As part of data collection, we observed link workers interacting with 35 patients. We also interviewed 61 patients and re-interviewed 41 of them 9-12 months later. Data were coded and developed into context-mechanism-outcome configurations, which were used to produce a programme theory. RESULTS: Data highlighted how patients might be uncertain about the link worker role but agree to a referral as they sought assistance with their non-medical issues. Patients talked about experiencing a sense of hope through the trust they developed in a link worker. This trust was established through the communication skills and knowledge demonstrated by a link worker, and by their ability to act as an anchor point when required - a reliable, consistent source of support to whom patients could offload. The link worker role also involved connecting patients to external support, which called for sensitivity around how ready someone was to move forward; this was shaped by a patient's motivation but also their capacity to make changes given other demands in their life. Connecting patients to external support could be affected by structural factors outside the link workers' control (e.g. housing options or employment opportunities). LIMITATIONS: We did not interview patients who had rejected the offer of social prescribing, and most had a positive view of meeting with a link worker. CONCLUSIONS: Person-centred care is engendered by link workers through their skills, knowledge and ability to respond to the individual readiness of patients to engage with external support. It can be curtailed by structural factors outside link workers' sphere of control, such as access to housing or caring responsibilities of patients. This can hinder patients' ability to 'connect to', leaving link workers to continue 'connecting with' patients as they act as an anchor point. FUTURE WORK: Exploration is required of factors affecting patients who interact with a link worker but do not access external support. Longitudinal work with a cohort of patients, speaking to them on a regular basis, may provide further understanding in this respect. FUNDING: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR130247.
Where do UK clinicians find information at the point of care? A pragmatic, exploratory study
Aim: To describe where clinical information is contemporarily and commonly found in UK primary care, what is favoured by clinicians, and whether this is (1) publicly funded (2) has commercial potential conflicts of interest. Design and setting: A mixed methods study, consisting of (1) site visits to general practices in Scotland, (2) online questionnaire, focused on UK general practice (3) analysis of materials cited by professionals. Methods: Data about sources of clinical information used was obtained verbally, visually and via search histories on computers from visits. This was used to inform a questionnaire in which primary care clinicians in the four nations of the UK were invited to participate. This obtained data about the information sources used and preferred by clinicians. This information was searched for data about funding and conflicts of interest. Results: Over 2022, four practices were visited. 337 clinicians, 280 of whom were general practitioners completed an online questionnaire. 136 different resources were identified. These were mainly websites but sources of information included colleagues, either in practice or through online networks, apps, local guidelines, health charities, and learning resources aimed at GPs. Of these, 70 were not publicly funded, and were a mixture of membership organisations, charities, or sponsored venues. Conclusions: Primary care clinicians obtain information for themselves and patients from a wide variety of sources. Funding is from a variety of sources and some contain advertising and/or sponsorship, risking commercial bias. Protocol: Pre-published at https://osf.io/wrzqk.