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Vaccines have been a key tool in stemming the tide of the COVID-19 pandemic. The rapid development of effective vaccines against COVID-19, together with their regulatory approval and wide scale distribution has been achieved in an impressively short period thanks to the intense efforts of many. In parallel to vaccine development, the EU considered it important to prepare for the independent control of the COVID-19 vaccines, including testing, to help ensure that only vaccines that comply with the approved quality requirements reach the public and to help improve/increase public confidence in the vaccines. The existing EU Official Control Authority Batch Release (OCABR) system, co-ordinated by the European Directorate for the Quality of Medicines and HealthCare (EDQM), was able to effectively respond to the need, through rapid co-ordination, work-sharing, advance planning and early interaction with manufacturers, the Coalition for Epidemic Preparedness Innovation (CEPI) and regulatory authorities. The Official Medicines Control Laboratories (OMCLs) involved in the OCABR activity, using the strength of the established system in the OCABR network and adaptations to the crisis conditions, were ready to release the first COVID-19 vaccine batches, after protocol review and testing, at the time of the conditional marketing authorisation for each of the COVID-19 vaccines, with no delay for batches reaching the public. Thanks to the dedication of resources by the EU and national authorities as well as by the EDQM, this was done without impacting the release of the other vaccines and human blood and plasma derived medicinal products, essential for public health. Transparency and communication of practices were important factors to support reliance on the OCABR outcome in non-EU countries, with the goal to improve access to vaccines in Europe and beyond. An overview of the process, legal background, challenges and successes of OCABR for COVID-19 vaccines as well as a look at the international perspective and lessons learned is provided.

This paper describes the people, activities and methods of consumer engagement in a complex research project, and reflects on the influence this had on the research and people involved, and enablers and challenges of engagement. The 2.5-year Integrating and Deriving Evidence Experiences and Preferences (IN-DEEP) study was conducted to develop online consumer summaries of multiple sclerosis (MS) treatment evidence in partnership with a three-member consumer advisory group. Engagement methods included 6-monthly face-to-face meetings and email contact. Advisory group members were active in planning, conduct and dissemination and translational phases of the research. Engaging consumers in this way improved the quality of the research process and outputs by: being more responsive to, and reflective of, the experiences of Australians with MS; expanding the research reach and depth; and improving the researchers’ capacity to manage study challenges. Advisory group members found contributing their expertise to MS research satisfying and empowering, whereas researchers gained confidence in the research direction. Managing the unpredictability of MS was a substantive challenge; the key enabler was the ‘brokering role’ of the researcher based at an MS organisation. Meaningfully engaging consumers with a range of skills, experiences and networks can make important and unforeseen contributions to research success.

Damage to the lymph channels prevents the return of this protein-laden fluid. Because of the high osmotic pull that the protein provides, water is pulled into the interstitial tissues, creating additional swelling. [...]the capillaries dilate to mitigate this effect.

Background and Aims In earlier work, we identified that people affected by multiple sclerosis (MS) can have difficulty finding online treatment information that is up to date, trustworthy, understandable, and applicable to personal circumstances, but does not provoke confusion or negative emotional consequences. The objective was to develop online consumer summaries of MS treatment evidence (derived from Cochrane Reviews) that respond to identified treatment information needs of people affected by MS. Methods A 2‐phase mixed‐methods project, conducted in partnership with consumers and an MS organisation. Phase 1 included review panels with consumers (Australians affected by MS) and health professionals to test paper‐based treatment summaries before development, and pilot testing of the website. Phase 2 involved an online survey after website launch. Results Eighty‐three participants (85% affected by MS) took part. Phase 1 participants strongly endorsed key review summary components, including layering information, and additional sections to aid personal applicability. Participants additionally suggested questions for health professionals. Participants across both phases were receptive to the idea of being provided with Cochrane Review summaries online but were seeking other types of evidence and information, such as personal experiences and the latest experimental treatments, which could not be provided. While the small survey sample size (n = 58) limits application of the results to a broader population, the website was viewed favourably, as a useful, understandable, and trustworthy information source. Conclusion We describe a partnership approach to developing online evidence‐based treatment information, underpinned by an in‐depth understanding of consumers' information needs. Background and Aims In earlier work, we identified that people affected by multiple sclerosis (MS) can have difficulty finding online treatment information that is up to date, trustworthy, understandable, and applicable to personal circumstances, but does not provoke confusion or negative emotional consequences. The objective was to develop online consumer summaries of MS treatment evidence (derived from Cochrane Reviews) that respond to identified treatment information needs of people affected by MS. Methods A 2‐phase mixed‐methods project, conducted in partnership with consumers and an MS organisation. Phase 1 included review panels with consumers (Australians affected by MS) and health professionals to test paper‐based treatment summaries before development, and pilot testing of the website. Phase 2 involved an online survey after website launch. Results Eighty‐three participants (85% affected by MS) took part. Phase 1 participants strongly endorsed key review summary components, including layering information, and additional sections to aid personal applicability. Participants additionally suggested questions for health professionals. Participants across both phases were receptive to the idea of being provided with Cochrane Review summaries online but were seeking other types of evidence and information, such as personal experiences and the latest experimental treatments, which could not be provided. While the small survey sample size (n = 58) limits application of the results to a broader population, the website was viewed favourably, as a useful, understandable, and trustworthy information source. Conclusion We describe a partnership approach to developing online evidence‐based treatment information, underpinned by an in‐depth understanding of consumers' information needs.

Purpose: To compare clinical outcomes in patients with pressure ulcers (PUs) who were treated with enzymatic debridement using clostridial collagenase ointment (CCO) with those treated with autolytic debridement using a hydrogel dressing. Patients and methods: This prospective, randomized, blinded, single-site trial directly compared the use of CCO and hydrogel dressings for treatment of PUs in patients in a long-term care facility. Changes in wound bed scores (WBS), tissue granulation, wound surface area, and epithelialization were assessed weekly during the 6-week treatment. Effects of treatment time, treatment method, and the combination of treatment time and method on continuous outcomes were analyzed by linear regression; the effects of covariates on epithelialization were analyzed by logistic regression. Results: Overall, 27 patients completed the study; 13 patients were treated with CCO and 14 with hydrogel. Baseline demographic and clinical characteristics were similar between the treatment groups. Patients treated with CCO had a granulation rate approximately twice that of those receiving hydrogel and showed a significantly higher rate of granulation tissue formation at week 6. Treatment duration and the combination of treatment duration and method were significant predictors of granulation tissue formation. WBS improvements from baseline to week 6 were greater in patients who received CCO than in those treated with hydrogel (+4.6 units versus +2.6 units, respectively). Treatment duration and the combination of treatment duration and method were predictors of WBS improvement. Patients treated with CCO showed significant reductions in wound surface area from baseline (10.3 cm2) to week 6 (2.1 cm2). At week 6, epithelialization was numerically higher in patients treated with CCO than in patients treated with hydrogel. Conclusion: Long-term care facility patients with PUs who received enzymatic debridement with CCO had greater improvements in granulation tissue formation, WBS, wound surface area, and wound closure than did those treated with hydrogel.

The management of wound exudate is a critical component of best practice, evidence‐based wound care. This analysis aimed to demonstrate the first clinical and performance outcomes of a newly designed, next generation five‐layer foam dressing for exudate management. A real‐world, retrospective cohort analysis was conducted at two healthcare organizations in the United States (US). Patients with acute or chronic wounds receiving a next generation five‐layer foam dressing were extracted from the organizations' Electronic Medical Record (EMR) systems. Utilizing descriptive statistics, the clinical outcomes and Healthcare Professional (HCP) reported dressing performance outcomes are reported. Twenty‐five patients with 28 acute or chronic wounds were evaluated during routine care, over a median treatment period of 42 days. Exudate levels improved, with high exudate decreasing from 60.7% to 39.3%, and favourable shifts in exudate type over time. Periwound condition improved, with maceration decreasing from 67.9% to 14.3%. Median wound area and volume decreased by 46.3% and 51.3%, respectively, with 17.9% of wounds achieving complete closure. HCP‐reported dressing performance exceeded expectations at 93%. This retrospective analysis demonstrates improvements in exudate levels, periwound status and wound status, alongside favourable HCP‐reported performance of a new next‐generation five‐layer foam dressing, during routine wound management. Key Points Exudate management from acute and chronic wounds is critical to enabling successful wound progression. This retrospective analysis reports the first clinical outcomes of a new next generation 5‐layer foam dressing in 25 patients. Improvement reported across exudate levels, exudate type and periwound condition, including reduction presence of maceration. Wound area and volume reduced by 46.3% and 51.3%, respectively. Dressing performance reported by HCPs exceeded 93%.

The growing burden of wounds is placing pressure on clinicians and healthcare providers globally. This study aimed to determine the impact of using a hydrocellular polyurethane foam dressing (HPFD) on weekly dressing changes in mixed aetiology wounds. A systematic literature review was performed to identify studies reporting HPFD use versus other/previous dressings via PubMed, EMBASE and the Cochrane Library. A total of four studies were found reporting the use of HPFD in comparison to other dressings (386 patients), with 3 of these studies specifically providing data for HPFD use versus other (non‐HPFD) foam dressings (136 patients). Meta‐analysis revealed mean differences of −1.66 [95% CI −1.87;−1.48] and −1.23 [95% CI −1.65;−0.83] dressing changes per week in favour of HPFD versus other dressings and other foam dressings, respectively. A cost calculator model assessed the economic impact of this reduction of dressing change frequency from US and UK payer perspectives and found a 41% and 36% relative reduction in dressing change‐related costs in hospital/clinic and community settings for both perspectives. These findings were stable under sensitivity analyses, which identified clinical time as being the predominant driver of costs in all settings. These findings highlight the importance of appropriate evidence‐based dressing selection in enabling the extension of dressing wear times. Key Points The increasing burden of wound management weighs heavily on already stretched clinical and financial resources within healthcare systems. Use of specific evidence‐based dressings led to a reduction in the number of mean weekly dressing changes in a variety of healthcare settings and wounds when compared to previously used dressings. A health economic model estimated that the reduction in dressing changes resulted in substantial cost savings, primarily through a reduction in nursing time. Evidence‐based dressing selection can drive meaningful efficiencies in wound care delivery by releasing clinical resource and reducing costs.

In this paper I examine my experience of submitting a research proposal to the Institutional Review Board of a university. In the United States of America Institutional Review Boards (IRBs) are federally mandated ethics committees that evaluate research proposals to ensure the rights of human subjects are protected by conducting a risk benefit analysis of proposed research, ensuring that informed consent and confidentiality protocols are applied appropriately, and that the selection of participants is just and equitable. While accepting the need for IRBs, I suggest that their documentation and practices privilege specific research practices. This paper seeks to highlight the emerging consistencies and contradictions of this documentation when applied to a research approach seeking to study an urban science classroom and argues that there needs to be an ongoing dialogue to examine and acknowledge these contradictions in their documentation. URN: urn:nbn:de:0114-fqs0501412

Skin tears are a common problem that can impact the quality of life due to pain and the potential of becoming complicated wounds if not treated properly. The use of a cyanoacrylate skin protectant to manage skin tears was evaluated in 30 patients in an acute care setting.