Evolution of the data and methods in real-world COVID-19 vaccine effectiveness studies on mortality: a scoping review protocol.

BACKGROUND: Early evidence on COVID-19 vaccine efficacy came from randomised trials. Many important questions subsequently about vaccine effectiveness (VE) have been addressed using real-world studies (RWS) and have informed most vaccination policies globally. As the questions about VE have evolved during the pandemic so have data, study design, and analytical choices. This scoping review aims to characterise this evolution and provide insights for future pandemic planning-specifically, what kinds of questions are asked at different stages of a pandemic, and what data infrastructure and methods are used? METHODS AND ANALYSIS: We will identify relevant studies in the Johns Hopkins Bloomberg School of Public Health VIEW-hub database, which curates both published and preprint VE RWS identified from PubMed, Embase, Scopus, Web of Science, the WHO COVID Database, MMWR, Eurosurveillance, medRxiv, bioRxiv, SSRN, Europe PMC, Research Square, Knowledge Hub, and Google. We will include RWS of COVID-19 VE that reported COVID-19-specific or all-cause mortality (coded as 'death' in the 'effectiveness studies' data set).Information on study characteristics; study context; data sources; design and analytic methods that address confounding will be extracted by single reviewer and checked for accuracy and discussed in a small group setting by methodological and analytic experts. A timeline mapping approach will be used to capture the evolution of this body of literature.By describing the evolution of RWS of VE through the COVID-19 pandemic, we will help identify options for VE studies and inform policy makers on the minimal data and analytic infrastructure needed to support rapid RWS of VE in future pandemics and of healthcare strategies more broadly. ETHICS AND DISSEMINATION: As data is in the public domain, ethical approval is not required. Findings of this study will be disseminated through peer-reviewed publications, conference presentations, and working-papers to policy makers. REGISTRATION: https://doi.org/10.17605/OSF.IO/ZHDKR.

Attitudes, beliefs, behaviours and perspectives on barriers and enablers of Australian general practitioners towards non-drug interventions: a national survey.

BACKGROUND: Many guidelines recommend non-drug interventions (NDIs) for managing common conditions in primary care. However, compared with drug interventions, NDIs are less widely known, promoted and used. We aim to (1) examine general practitioners' (GPs') knowledge, attitudes and practices for NDIs, including their use of the Royal Australian College of General Practitioners (RACGP) Handbook of Non-Drug Interventions (HANDI), and (2) identify factors influencing their use of NDIs and HANDI. METHODS: We conducted a web-based cross-sectional survey of practicing GP members in Australia during October-November 2022. The survey contained five sections: characteristics of GP; knowledge and use of NDIs; attitudes towards NDIs; barriers and enablers to using HANDI; and suggestions of NDIs and ideas to improve the uptake of NDIs in primary care. RESULTS: Of the 366 GPs who completed the survey, 242 (66%) were female, and 248 (74%) were ≥45 years old. One in three GPs reported that they regularly ('always') recommend NDIs to their patients when appropriate (34%), whereas one-third of GPs were unaware of HANDI (39%). GPs identified several factors that improve the uptake of HANDI, including 'access and integration of HANDI in clinical practice', 'content and support to use in practice' and 'awareness and training'. CONCLUSIONS: While many GPs are aware of the effectiveness of NDIs and often endorse their use, obstacles still prevent widespread adoption in primary care. The results of this survey can serve as a foundation for developing implementation strategies to improve the uptake of effective evidence-based NDIs in primary care.

Introduction of allergenic food to infants and allergic and autoimmune conditions: a systematic review and meta-analysis.

OBJECTIVES: To evaluate the effects of early introduction to allergenic foods compared with late introduction and its impact on food allergy, food sensitisation and autoimmune disease risk. DESIGN AND SETTING: The systematic review was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. Four electronic databases (MEDLINE, CENTRAL, EMBASE and CINAHL) were searched from inception till 24 October 2022 using keywords and MeSH without limitations on publication's language or date. A forward and backwards citation analysis was also conducted. Risk of bias was assessed by three authors independently, in pairs using the Cochrane Risk of Bias Tool 2. Findings were narratively and quantitatively synthesised. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. PARTICIPANTS: Randomised controlled trials (RCTs) on allergenic food introduction prior to 12 months of age that evaluated its effect on the development of allergic and autoimmune conditions. INTERVENTION: Early introduction to allergenic foods to infants diet. MAIN OUTCOME MEASURES: (1) Food allergy and sensitisation with main measures including oral food challenge, specific-IgE, skin prick testing, physician assessment and parental reporting. (2) Allergic and autoimmune conditions such as asthma and eczema. RESULTS: Of the 9060 identified records, we included 12 RCTs. We found high to moderate certainty evidence suggested that early introduction of allergen-containing foods reduces the risk of multiple food allergies (4 RCTs, 3854 participants, RR 0.49, 95% CI 0.33 to 0.74), egg (8 RCTs, 5193 participants, RR 0.58, 95% CI 0.44 to 0.78), peanut (3 RCTs, 4183 participants, RR 0.31, 95% CI 0.17 to 0.54) and atopic dermatitis or eczema (4 RCTs, 3579 participants, RR 0.88, 95% CI 0.78 to 1.00). Effects on other food allergies including milk, wheat, fish; autoimmune conditions, and food sensitisation are very uncertain and informed by low and very-low certainty evidence. No important subgroup differences were observed related to baseline risk of allergy and age at introduction. Sensitivity analyses limited to low risk of bias RCTs showed similar results. CONCLUSIONS: This systematic review and meta-analysis shows that early introduction of allergen-containing food from 4 to 12 months of age, was associated with lower risk of multiple food allergy and eczema. Further research on other allergenic foods, and their long-term impact on food allergy and autoimmune risk is essential for enhancing our understanding on development of these conditions and guiding future clinical recommendations. PROSPERO REGISTRATION NUMBER: CRD42022375679.

Feasibility, satisfaction, acceptability and safety of telehealth for First Nations and culturally and linguistically diverse people: a scoping review.

OBJECTIVES: The COVID-19 pandemic has highlighted the importance of access to telehealth as an alternative model of service during social restrictions and for urban and remote communities alike. This study aimed to elucidate whether First Nations and culturally and linguistically diverse (CALD) patients also benefited from the resource before or during the pandemic. STUDY DESIGN: This study was a scoping review. METHODS: A scoping review of MEDLINE, CINAHL and PsycINFO databases from 2000 to 2021 was performed. Paired authors independently screened titles, abstracts and full texts. A narrative synthesis was undertaken after data extraction using a standard template by a team including First Nations and CALD researchers. RESULTS: Seventeen studies (N = 4,960 participants) mostly qualitative, covering First Nations and CALD patient recipients of telehealth in the United States, Canada, Australia, and the Pacific Islands, met the inclusion criteria. Telehealth was perceived feasible, satisfactory, and acceptable for the delivery of health screening, education, and care in mental health, diabetes, cancer, and other chronic conditions for remote and linguistically isolated populations. The advantages of convenience, lower cost, and less travel promoted uptake and adherence to the service, but evidence was lacking on the wider availability of technology and engagement of target communities in informing priorities to address inequalities. CONCLUSIONS: Further studies with larger samples and higher level evidence methods involving First Nations and CALD people as co-designers will assist in filling the gap of safety and cultural competency.

Efficacy of topical cadexomer iodine treatment in chronic wounds: Systematic review and meta-analysis of comparative clinical trials.

The aim of this study was to summarise the clinical evidence supporting almost 40 years of topical cadexomer iodine (CIOD) use in wound bed preparation by removing barriers to healing such as exudate, slough, bioburden, and infection and allowing chronic wound progression. A systematic review was conducted (Embase/PubMed, November 2020) to identify relevant comparative studies meeting inclusion criteria. Meta-analyses were performed using a fixed-effects (I2 < 50%) or random-effects model (I2 ≥ 50%) depending on statistical heterogeneity. Dichotomous outcomes were reported as relative risk (RR) and continuous outcomes as mean difference (MD), with 95% confidence intervals. In total, 436 publications were identified of which 13 were comparative trials including outcomes of interest. Significant reductions in exudate, pus/debris, slough, bioburden, and infection were reported in chronic wounds treated with CIOD, compared with standard of care (SOC). Meta-analyses highlighted the positive impact of CIOD on mean wound area reduction (MD = 2.35 cm2 , 95% CI = 0.34-4.36, P = .0219) after eight weeks treatment and overall wound healing events compared to SOC; wounds including venous leg ulcers, diabetic foot ulcers, and pressure ulcers treated with CIOD were more than twice as likely to heal than those receiving SOC (RR = 2.30, 95% CI = 1.54-3.45, P < .0001). This meta-analysis demonstrates the efficacy of CIOD on chronic wounds through removal of barriers to healing. CIOD should be considered in wound bed preparation and treatment protocols.

TIME CDST: an updated tool to address the current challenges in wound care.

Despite the understanding that wounds are a common problem affecting the individual, the health service and society as a whole, there continues to be a lack of a systematic, structured, evidence-based approach to wound management. The TIME principle was first published in 2003, 1 and has since been integrated by many into clinical practice and research. However, this tool has been criticised for its tendency to focus mainly on the wound rather than on the wider issues that the patient is presenting with. At an expert meeting held in London in 2018, this conundrum was addressed and the TIME clinical decision support tool (CDST) was elaborated upon. This article introduces the TIME CDST, explains why it is required and describes how its use is likely to benefit patients, clinicians and health-service organisations. It also explores the framework in detail, and shows why this simple and accessible framework is robust enough to facilitate consistency in the delivery of wound care and better patient outcomes. Finally, it outlines the next steps for the rollout, use and evaluation of the impact of the TIME CDST.

T.I.M.E. to improve patient outcomes: use of a clinical decision support tool to optimise wound care.

Patients with wounds pose an important healthcare challenge. Many of these wounds are managed in community care and can take weeks or months to resolve. Delays in wound healing can be perpetuated by clinicians who make poor treatment choices, fail to recognise complications and/or do not seek timely advice. Improving patient outcomes requires a proactive approach to care that includes accurate and timely assessment and re-assessment, treatment of the underlying cause using a multidisciplinary team approach and the use of evidence-based practice and clinical judgement to develop an appropriate treatment plan. A structured approach to care, such as the newly developed T.I.M.E. clinical decision support tool, has the potential to improve wound healing outcomes and reduce the burden of chronic wounds in community nursing services.

Using a modified Delphi methodology to gain consensus on the use of dressings in chronic wounds management.

OBJECTIVE: Managing chronic wounds is associated with a burden to patients, caregivers, health services and society and there is a lack of clarity regarding the role of dressings in improving outcomes. This study aimed to provide understanding on a range of topics, including: the definition of chronicity in wounds, the burden of illness, clinical outcomes of reducing healing time and the impact of early interventions on clinical and economic outcomes and the role of matrix metalloproteinases (MMPs) in wound healing. METHOD: A systematic review of the literature was carried out on the role of dressings in diabetic foot ulcer (DFU), and venous leg ulcer (VLU) management strategies, their effectiveness, associated resource use/cost, and quality of life (QoL) impact on patients. From this evidence-base statements were written regarding chronicity in wounds, burden of illness, healing time, and the role of MMPs, early interventions and dressings. A modified Delphi methodology involving two iterations of email questionnaires followed by a face-to-face meeting was used to validate the statements, in order to arrive at a consensus for each. Clinical experts were selected, representing nurses, surgeons, podiatrists, academics, and policy experts. RESULTS: In the first round, 38/47 statements reached or exceeded the consensus threshold of 80% and none were rejected. According to the protocol, any statement not confirmed or rejected had to be modified using the comments from participants and resubmitted. In the second round, 5/9 remaining statements were confirmed and none rejected, leaving 4 to discuss at the meeting. All final statements were confirmed with at least 80% consensus. CONCLUSION: This modified Delphi panel sought to gain clarity from clinical experts surrounding the use of dressings in the management of chronic wounds. A full consensus statement was developed to help clinicians and policy makers improve the management of patients with these conditions.

Venous leg ulcer management: single use negative pressure wound therapy.

A number of leg ulcer specialist/tissue viability specialists from across the UK were invited to evaluate PICO (Smith and Nephew, Hull) as a treatment for venous leg ulcers also in conjunction with a variety of compression bandages and garments. Patients across 5 sites had PICO applied in conjunction with compression therapy. This group of treating clinicians were then asked to give feedback on the outcome of the patients on whom they had used the new device. All feedback was recorded at a meeting and this was used to create a guideline for use.

The economic benefits of negative pressure wound therapy in community-based wound care in the NHS.

The human and economic costs of wounds are of major concern within today's National Health Service. Advances in wound care technology have been shown to be beneficial both in healing and in relation to patient quality of life. Negative pressure has often been associated with high-cost care and restricted to use in the secondary care setting. There is growing use of negative pressure within the community, and this has the potential to benefit the patient and the service by providing quality care in the patient's home setting. Three community sites were chosen to monitor their use of negative pressure wound therapy (NPWT) over a period of 2 years, and this paper presents some of the key findings of this work. The data generated has been used to help target resources and prevent misuse of therapy. Cost per patient episode has been calculated, and this can be compared to similar costs in secondary care, showing significant savings if patients are discharged earlier from secondary care. There is also an increased demand for more patients with complex wounds to be cared for in the community, and in the future, it is likely that community initiated NPWT may become more common. Early analysis of the data showed that the average cost of dressing complex wounds would be significantly less than using traditional dressings, where increased nursing visits could increase costs. There is a compelling argument for more negative pressure to be used and initiated in the community, based not only on improved quality of life for patients but also on the economic benefits of the therapy.

Managing wound exudate: role of Versiva XC gelling foam dressing.

Effective management of wound exduate is a considerable challenge for clinicians. Treatment of the patients underlying condition, accurate assessment of the wound and exudate, as well as selection of an appropriate dressing are all important factors for success. A variety of dressings are available to the clinician for the management of exudate, but not all handle fluid in the same way. A gelling foam dressing combining foam with Hydrofiber technology is described and the supporting evidence for its use reviewed. Versiva XC dressing has some good evidence to support its use in the management of wound exudate and performs well in clinical practice.

Using the TIME framework in wound bed preparation.

This article discusses the concept of wound bed preparation and the associated TIME framework, as a systematic approach to wound assessment. Successful outcomes for patients with wounds relies on identification and treatment of the underlying cause of the wound and management of issues at the wound bed that impact on healing. This systematic approach can improve wound assessment and assist with treatment choices for patients, so as to optimize wound care for patients.

Assessing mixed venous and arterial leg ulcers.

Caroline Dowsett outlines the key points in the assessment and management of mixed venous and arterial leg ulcers so that readers can consider their own practice against expert opinion.

Managing leg ulceration in patients with sickle cell disorder.

Leg ulceration is a complication associated with sickle cell disorders. Caroline Dowsett outlines why this problem occurs and describes the management of a patient with sickle cell disorder who presented with an infected leg ulcer. She concludes that there is a need for more research into the management of these complex wounds.

Assessment and management of patients with leg ulcers.

This article discusses the assessment and management of patients with leg ulcers, focusing on venous, arterial and mixed aetiology ulcers. Successful care planning should be based on working in partnership with patients in terms of offering choices that meet their clinical, quality-of-life and psychosocial needs.

The use of silver-based dressings in wound care.

Chronic wounds such as leg ulcers and pressure ulcers are often slow to heal. One of the causes of delayed wound healing is the presence of micro-organisms in the wound. A strategy for the prevention and treatment of wound colonisation or infection, which is receiving renewed attention, is the use of silver-based dressings. Silver has been used as an antimicrobial agent for centuries. It is effective against a broad range of bacteria (including methicillin and vancomycin-resistant strains), yeast, fungi and viruses. A number of new silver-based dressings, some of which act by the sustained release of silver ions to the wound bed, have recently become available, but there are wide variations in the amount of data supporting the use of individual products. This article reviews the evidence base for silver-containing dressings to help practitioners select the most appropriate product for the type of wound being treated.