Between donation and exchange. The plasma supply chain in the Italian transfusion system

The Italian transfusion system is based on the public property of blood and its derivatives: any commodification is refused and the USA model is avoided, as Richard Titmuss recommended. Nevertheless, the for profit sector comes into play with regard to plasma manufacturing. This "plasma supply chain” relies on a complex collaboration among the Italian NHS' top institutions (Ministry of Health and Regions), four Third Sector Organizations which gather voluntary donors, and four for profit firms which produce Plasma-Derived Medicinal Products. Through a qualitative methodological approach, this article aims to explore such a mechanism, investigating its strengths and weaknesses, comparing it to other systems worldwide and analysing its reaction to the Covid-19 pandemic. The final aim is considering and evaluating it in light of both Titmuss' position and Achille Ardigò's viewpoint about the usefulness of a "triple pole model”. Copyright © FrancoAngeli.

Tra dono e scambio. La "filiera” del plasma nel sistema trasfusionale italiano

The Italian transfusion system is based on the public property of blood and its derivatives: any commodification is refused and the USA model is avoided, as Richard Titmuss recommended. Nevertheless, the for profit sector comes into play with regard to plasma manufacturing. This "plasma supply chain” relies on a complex collaboration among the Italian NHS' top institutions (Ministry of Health and Regions), four Third Sector Organizations which gather voluntary donors, and four for profit firms which produce Plasma-Derived Medicinal Products. Through a qualitative methodological approach, this article aims to explore such a mechanism, investigating its strengths and weaknesses, comparing it to other systems worldwide and analysing its reaction to the Covid-19 pandemic. The final aim is considering and evaluating it in light of both Titmuss' position and Achille Ardigò's viewpoint about the usefulness of a "triple pole model”. Copyright © FrancoAngeli.

From COVID-19 to Green Recovery with natural capital accounting

The COVID-19 pandemic and related social and economic emergencies induced massive public spending and increased global debt. Economic recovery is now an opportunity to rebuild natural capital alongside financial, physical, social and human capital, for long-term societal benefit. Yet, current decision-making is dominated by economic imperatives and information systems that do not consider society's dependence on natural capital and the ecosystem services it provides. New international standards for natural capital accounting (NCA) are now available to integrate environmental information into government decision-making. By revealing the effects of policies that influence natural capital, NCA supports identification, implementation and monitoring of Green Recovery pathways, including where environment and economy are most positively interlinked. © 2022, The Author(s).

From COVID-19 to Green Recovery with natural capital accounting

The COVID-19 pandemic and related social and economic emergencies induced massive public spending and increased global debt. Economic recovery is now an opportunity to rebuild natural capital alongside financial, physical, social and human capital, for long-term societal benefit. Yet, current decision-making is dominated by economic imperatives and information systems that do not consider society's dependence on natural capital and the ecosystem services it provides. New international standards for natural capital accounting (NCA) are now available to integrate environmental information into government decision-making. By revealing the effects of policies that influence natural capital, NCA supports identification, implementation and monitoring of Green Recovery pathways, including where environment and economy are most positively interlinked.

Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY): statistical analysis plan for a randomised controlled Bayesian adaptive sample size trial.

The CLARITY trial (Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease) is a two-arm, multi-centre, randomised controlled trial being run in India and Australia that investigates the effectiveness of angiotensin receptor blockers in addition to standard care compared to placebo (in Indian sites) with standard care in reducing the duration and severity of lung failure in patients with COVID-19. The trial was designed as a Bayesian adaptive sample size trial with regular planned analyses where pre-specified decision rules will be assessed to determine whether the trial should be stopped due to sufficient evidence of treatment effectiveness or futility. Here, we describe the statistical analysis plan for the trial and define the pre-specified decision rules, including those that could lead to the trial being halted. The primary outcome is clinical status on a 7-point ordinal scale adapted from the WHO Clinical Progression scale assessed at day 14. The primary analysis will follow the intention-to-treat principle. A Bayesian adaptive trial design was selected because there is considerable uncertainty about the extent of potential benefit of this treatment.Trial registrationClinicalTrials.gov NCT04394117 . Registered on 19 May 2020Clinical Trial Registry of India CTRI/2020/07/026831Version and revisionsVersion 1.0. No revisions.

FAECAL IMMUNOCHEMICAL TEST (FIT) FOR TRIAGING SYMPTOMATIC PATIENTS – PUTTING UK NICE GUIDELINES INTO PRACTICE

Introduction: Endoscopy Capacity Has Been Under Pressure During The Covid19 Crisis. Fit Affords The Opportunity To Identify A High Risk Group In Whom Urgent Colonoscopy Can Be Justified To Exclude Colorectal Cancer (Crc). It Allows Identifying Patients In The Low Risk Group In Whom Any Endoscopy Avoided. We Describe Our Experience Of Using Quantitative Fit To Guide Referral For Crc From Primary Care Using The Uk Nice Guidance Criteria. Methodology: Over A Six Month Period All Patients Were Assessed During Consultation In Primary Care To Determine If They Met The Criteria Of Nice Ng12 Or The Dg30 Guidelines. Fit Was Requested At The Time Of This Assessment. The Ng12 Guideline States That Patients Over 40 Years With Unexplained Weight Loss And Abdominal Pain, Patients Over 50 With Unexplained Rectal Bleeding And Patients Over 60 With Iron Deficiency Anaemia And Change In Bowel Habit Should All Be Referred For Suspicion Of Crc On The High Risk Pathway. The Dg30 Guideline Advises Patients To Be Referred On The Low Risk Pathway If Patients Is Aged 50 And Over With Unexplained Abdominal Pain Or Weight Loss, Patients Aged 60 And Under With Change In Bowel Habits Or Iron Deficiency Anaemia. All Patients On The High Risk Pathway (Ng12) Were Referred Into Secondary Care For Assessment / Investigations While Patients On The Low Risk Pathway (Dg30) Were Referred Only If They Met The Fit Threshold Of 10 Μg Hb/G Or Had New Iron Deficiency Anaemia. In Secondary Care, Clinical Judgement Was Applied Regarding The Need For Any Further Investigations. Results: 535 Patients Fulfilled The Criteria For The Low Risk Pathway And 364 Were On The High Risk Pathway. Only 19% (N = 101) Of The Patients On The Low Risk Pathway Met The Criteria For Secondary Care Referral Based On The Results Of The Fit Or Iron Deficiency. For The Patients On The High Risk Pathway, 133 Patients Were Downgraded In Priority As The Fit Test Were < 10 Μg Hb/G, 168 Patients Had Fit Test Between 10 And 99 Μg Hb/G And 28 Patients Had Results > 100 Μg Hb/G. The Median Age On Referral Was 73 With 11% Of All Patients Aged Below 50 Years. A Total Of 14 Cancers Were Diagnosed In This Group With 9 Crc And 5 Extra Colonic Cancers. All The Patients With Crc Had Fit > 100 Μg Hb/G (Pick Up Rate Of 22%). No Crc Were Diagnosed In Patients In The Intermediate Or Low Range Fit Test. Conclusion: Fit Is Likely To Be A Clinically Effective And Cost-Effective Strategy For Triaging People Who Are Presenting, In Primary Care Settings, With Lower Abdominal Symptoms And Who Are At Low Risk For Crc When Using The Dg30 And Ng12 Nice Criteria. References: Nice. Suspected Cancer: Recognition And Referral. National Institute For Health And Care Excellence, 2015. Nice. Quantitative Faecal Immunochemical Tests To Guide Referral For Crc In Primary Care. National Institute For Health And Care Excellence, 2017.

Virtual reality hospital: Developing a patient centred virtual environment to reduce preprocedural anxiety in children and young people

Background Anxiety is a common experience among Children and Young People (CYP) attending hospital for a procedure under general anaesthetic, some of whom require anxiolytic medication. Methods to reduce anxiety, such as hospital tours, have not been possible during the COVID-19 pandemic prompting us to reimagine how these can be delivered. Use of Virtual Reality (VR) in Paediatrics has largely focused on distraction during a procedure but VR can be effectively used preoperatively to reduce anxiety. Preadmission use of VR to reduce anxiety has also demonstrated a potential health economic benefit. We describe progress in developing a VR environment to simulate hospital tours in a Paediatric Hospital in the United Kingdom. Objectives Improve the patient experience by reducing preprocedural anxiety in CYP attending for a planned procedure under general anaesthetic, using VR technology to simulate a tour of an anaesthetic room. The VR environment must be accessible and interactive for CYP aged 8-21 years using a smartphone or device and VR headset at home, the content and design of which is informed by the experience and opinions of CYP at every stage of development. Methods Initial input of CYP was sought at a Young People's Forum. Discussions informing both the content and design were facilitated by healthcare professionals and involved CYP aged 10-18 years. A VR developer then created a digitally rendered anaesthetic room to produce a minimum viable product (MVP) using 'Autodesk Maya' and 'Unity' software. A 360° video of an anaesthetic room was also developed. Information provided within the VR environment was produced by Paediatric Healthcare professionals with input from experts in acute Paediatric anxiety. Focus groups of CYP will provide qualitative feedback to drive improvement cycles of the VR environment on a regular basis along with integration of interactivity and gamification. Following this patients will be invited to experience the virtual environment. Results CYP felt that a VR environment could help reduce preprocedure anxiety. They identified reducing uncertainty, optimising comfort, familiarity and trust in healthcare professionals and understanding medical devices and the physical experience as key factors for consideration when developing the VR environment. A calm environment with a relatable character, interactivity and gamification were identified as design priorities. The initial focus group review of the MVP is scheduled imminently with a plan to complete improvement cycles on a three monthly basis. Patients will be offered the opportunity to explore the VR environment at their pre-assessment appointment if the healthcare team and parent/guardian believe they may benefit. Conclusions Preprocedure anxiety is a major factor affecting the experience of CYP. This project aims to counter that using VR technology. The engagement of key stakeholders to inform throughout development ensures constant relevance is maintained in design and delivery. Reducing uncertainty, optimising familiarity and trust in the healthcare environment and team were identified as key factors in reducing anxiety. Interactivity and gamification are important in enhancing engagement. Ongoing review with CYP will shape and extend this tool with a view to building an interactive VR hospital allowing exploration of the whole hospital journey.

Faecal immunochemical test (FIT) in secondary care: Prioritising lower GI two week wait patients during the COVID19 pandemic

Introduction: FIT provides a safe, rapid and accurate way to determine a patient's risk of having a lower GI cancer and it may possibly be used to exclude cancer for patients with negative result. It will reduce primary care referrals by enabling GPs to determine likelihood of lower GI cancer before referral whilst adhering with UK NICE guidance and enable clinicians to triage patients referred on the rapid access suspected caner pathway for endoscopy. This study is an interim report of the work performed by the Cheshire and Merseyside Cancer Alliance (CMCA), which covers a population of 2.5 million, looking at the use of FIT testing for prioritising patients with suspected cancer during the COVID pandemic when standard pathways were not possible. Aims & Methods: During the initial phase of the COVID19 pandemic, nonessential endoscopy services were halted. As a result, by May 2020, there were over 1,400 lower GI suspected cancer referrals on hold. Furthermore, an estimated 4,500 lower GI suspected cancer referrals were expected due to patients not visiting their GP during the pandemic. CMCA worked with seven hospital sites over eight weeks to implement a secondary care-based FIT system to prioritise eligible lower GI 2WW patients for investigation. Two CMCA FIT pilot studies carried out to prior to final implementation plan. Patients who were referred via the 2WW lower GI cancer service with symptoms that met NICE guidance referral criteria were given FIT test as primary investigation. Rectal bleeding and abdominal/ rectal mass were excluded from this pathway. Following the result patients were prioritised into 3 groups (1a (positive) Iron Deficiency Anaemia (IDA) or >100μg, 1b (positive) 10-99μg and 1c (negative) <10μg no IDA). Groups 1a and 1b were triaged to urgent investigations and 1c safety netted and kept on a patient tracking list. All 6 sites were tasked to collect data on a minimum data set to ensure concordance. Results: 1567 patients underwent FIT test till date with (mean age 68). 32% (n=497) of patients had a FIT result less than 10ug and no IDA, resulting in transfer from a 2WW to a routine pathway. 30% (n=471) of patients tested had a FIT result greater than or equal to 10ug. Such patients have at least a 4.8% risk of colorectal cancer and were prioritised for investi gation. Of these patients, 9% (n=135) had a FIT result ≥ 100ug, indicating urgent investigation needed. 32 cancers were diagnosed, representing 2.0% of all patients. Of these cancers, 25 were colorectal cancers (1.6%) and seven non GI cancers. All 25 colorectal cancers were found in patients with FIT≥10ug. For patients with FIT > 100μg and 10-99μg, the pickup rate of bowel malignancy was 7.4 % and 2.1% respectively. Only 12% of colorectal cancers were found at an early stage (1 or 2) and only 18 of 25 cancers had a known stage, however numbers were small. Within 6 weeks of implementation, secondary care FIT for high risk patients during the COVID19 lockdown resulted in a substantial reduction in the numbers of suspended lower GI TWW referrals. Conclusion: During the COVID pandemic FIT has been a useful tool to help reduce the backlog of 2ww lower GI referrals and helped to prioritise endoscopic examinations needed. This has saved money and has provided the ability to discharge low risk patients back to primary care while decreasing the wait for patients needing colonoscopy. More studies are required to ensure that discharged patients remained cancer free, cost effectiveness of FIT nationally and the effect of medication upon the sensitivity/ specificity of FIT.

POS-527 CONTINUUM OF CARE AMONG PARTICIPANTS OF DIALYSIS OUTCOMES REGISTRY IN INDIA DURING THE COVID-19 PANDEMIC LOCKDOWN

Introduction: Majority of ESKD patients in India avail in centre dialysis services. India imposed a nation-wide lockdown for over two months during the COVID-19 pandemic. Essential healthcare services including dialysis were disrupted. Patients on dialysis faced severe consequences as they as could not seek care at the health care facilities.1,2,3These disruptions have impacted the continuum of care and altered the care-seeking behaviour among dialysis patients.4,5 We monitored the care-seeking behaviour among dialysis patients enrolled in the India Dialysis Outcomes Registry during the lockdown. Methods: The India dialysis outcomes registry is a nationally representative study following up 1000 ESKD patients starting dialysis across 10 Indian states. The registry has established a mechanism for routine data collection on clinical, socio economic outcomes and patient reported quality of life. We contacted the participants telephonically to understand the continuum of care during the lockdown. Efforts were directed to describe reasons for missing dialysis session(s) and document any complications due to disruptions to the dialysis services. Results: We followed-up 526 participants at 9 dialysis centres after the onset of the Pandemic in India, 149 (28)% were not contactable after 3 attempts. 377 participants (61% males and 39% females) consented and participated in the telephonic survey. Of these, 270 (72 %) were continuing on hemodialysis, 83 (22%) died, 7 (2%) switched to Peritoneal Dialysis, while 3 % (12) had either received or were awaiting kidney transplant and 5(1%) had stopped dialysis. During the interviews, 31 (8 %) reported having missed prescribed dialysis sessions ranging from one missed session to 24 missed sessions. The reasons being, travel ban on account of the COVID-19 pandemic (68%), financial challenges (19%), transfer to another site (3%) and other reasons (29%) like hike in dialysis cost during pandemic, non-availability of dialysis sessions as facilities were designated as COVID-19 management units, absence of dialysis facilities in COVID-19 wards and non-availability of dialysis staff as they were quarantined (Figure 1). Out of those continuing dialysis, 15% reported being hospitalized during the pandemic. They were admitted due to poor vascular access (61%), infections (29%) and 8 patients reported testing positive for COVID-19. Other reasons for hospitalizations were cardiovascular complications and stroke.(Figure 2) Conclusions: The disruption to continuum of care for patients on dialysis due to travel restrictions during COVID-19 lockdown, not only resulted in difficulty in accessing the dialysis care but also contributed to worsening of their overall health. Our study also elicits patient’s experiences and their perspectives on the challenges faced by them during the lockdown. They identified lack of clear communications by health facilities, lack of adequate dialysis treatment facilities and non-availability of staff at dialysis units. The India Dialysis Registry helped understand the disruptions in continuity of services among a representative population across the country during the COVID19 pandemic, this iterates the significance of establishing disease registries to monitor outcomes longitudinally. Insights as gained from our registry will be critical to inform policy makers in time and thereby address gaps in health delivery systems in India. Conflict of Interest: OJ is recipient of a UIPA scholarship from University of New South Wales, Sydney.