PUFchain 3.0: Hardware-Assisted Distributed Ledger for Robust Authentication in Healthcare Cyber-Physical Systems.

This article presents a novel hardware-assisted distributed ledger-based solution for simultaneous device and data security in smart healthcare. This article presents a novel architecture that integrates PUF, blockchain, and Tangle for Security-by-Design (SbD) of healthcare cyber-physical systems (H-CPSs). Healthcare systems around the world have undergone massive technological transformation and have seen growing adoption with the advancement of Internet-of-Medical Things (IoMT). The technological transformation of healthcare systems to telemedicine, e-health, connected health, and remote health is being made possible with the sophisticated integration of IoMT with machine learning, big data, artificial intelligence (AI), and other technologies. As healthcare systems are becoming more accessible and advanced, security and privacy have become pivotal for the smooth integration and functioning of various systems in H-CPSs. In this work, we present a novel approach that integrates PUF with IOTA Tangle and blockchain and works by storing the PUF keys of a patient's Body Area Network (BAN) inside blockchain to access, store, and share globally. Each patient has a network of smart wearables and a gateway to obtain the physiological sensor data securely. To facilitate communication among various stakeholders in healthcare systems, IOTA Tangle's Masked Authentication Messaging (MAM) communication protocol has been used, which securely enables patients to communicate, share, and store data on Tangle. The MAM channel works in the restricted mode in the proposed architecture, which can be accessed using the patient's gateway PUF key. Furthermore, the successful verification of PUF enables patients to securely send and share physiological sensor data from various wearable and implantable medical devices embedded with PUF. Finally, healthcare system entities like physicians, hospital admin networks, and remote monitoring systems can securely establish communication with patients using MAM and retrieve the patient's BAN PUF keys from the blockchain securely. Our experimental analysis shows that the proposed approach successfully integrates three security primitives, PUF, blockchain, and Tangle, providing decentralized access control and security in H-CPS with minimal energy requirements, data storage, and response time.

Ultrathin Hollow Co/N/C Spheres from Hyper-Crosslinked Polymers by a New Universal Strategy with Boosted ORR Efficiency.

Porous carbon materials with hollow structure, on account of the extraordinary morphology, reveal fascinating prospects in lithium-ion batteries, electrocatalysis, etc. However, collapse in ultrathin carbon spheres due to insufficient rigidity in such thin materials obstructs further enhanced capability. Based on hyper-crosslinked polymers (HCPs) with sufficient pore structure and rigid framework, a new bottom-up strategy is proposed to construct SiO2 @HCPs directly from aromatic monomers. Heteroatom and function groups can be facilely introduced to the skeleton. The thickness of HCPs' wall can be tuned from 9 to 20 nm, which is much thinner than that of hollow sphere synthesized by the traditional method, and the sample with a thickness of 20 nm shows the highest surface area of 1633 m2 g-1 . The oxygen reduction reaction is conducted and the CoNHCS electrocatalysts with an ultrathin thickness of 5 nm display higher half-wave potential than those of bulk samples, even better than commercial Pt/C electrode. On account of the hollow structure, the relative current density loss of electrocatalysts is only 4.1% in comparison with 27.7% in Pt/C electrode during the 15 000 s test, indicating an obvious higher long-term stability. The new strategy to construct hollow HCPs may shed light on efficient chemical catalysis, drug delivery, and electrocatalysis.

Onco-pharmacist led evaluation of knowledge, attitude & practice (KAP) of safe handling cytotoxic drugs among health care professional's (HCP's) in tertiary care hospital: A hospital based interventional Study.

BACKGROUND: Cytotoxic drugs (CDs) are hazardous in nature. But it is necessary for the treatment in cancer patients. The healthcare professionals (HCPs) act as a facilitator through which the manufactured CDs reach the patient. However, safe handling of CDs becomes a primary concern not only for the recipients but also for the HCPs. METHODS: On Ethics committee approval, a prospective- interventional study was conducted among HCPs who are involved in handling of CDs in Oncology department of tertiary care hospital. The participants were screened for their eligibility criteria & 73 HCPs were recruited. The initial data was collected from the HCPs through interview & questionnaires. Later the participants were trained by oncology-pharmacist (7-8 months) for safe handling of CDs. After the training the participants were tested again through interview & questionnaires. RESULTS: 73 participants, (75%) nurses & (25%) physicians were included in the study. Among these participants, only 32.87% underwent training on reconstitution whereas 67.12% of the participants didn't undergo any training. The increase in mean score of KAP after the training was observed to be 3.44 ± 4.32, 1.23 ± 1.51 and 1.3 ± 1.01 respectively. CONCLUSION: The study concludes that mandatory requirement of training for HCPs using SOP's by qualified oncology-pharmacist to minimize the hazardous effects of CDs. It also highlights the improvisation techniques for handling of CDs will enhance the safety profile of HCPs & the patients, which helps in refining the quality of pharmaceutical and health care services provided in the cancer care settings.

Current Management of Patients with RPE65 Mutation Associated Inherited Retinal Degenerations in Europe: Results of a 2-Year Follow-Up Multinational Survey.

INTRODUCTION: The aim of this study was to evaluate the current management of RPE65 biallelic mutation-associated inherited retinal degeneration (RPE65-IRD) in Europe since market authorization of voretigene neparvovec (VN, LuxturnaTM) in 2018. By July 2022, over 200 patients have been treated outside the USA, of whom about 90% in Europe. We conducted among all centers of the European Vision Institute Clinical Research Network (EVICR.net) and health care providers (HCPs) of the European Reference Network dedicated to Rare Eye Diseases (ERN-EYE) the second multinational survey on management of IRDs in Europe elaborated by EVICR.net with a special focus on RPE65-IRD. METHODS: An electronic survey questionnaire with 48 questions specifically addressing RPE65-IRD (2019 survey 35) was developed and sent by June 2021 to 95 EVICR.net centers and 40 ERN-EYE HCPs and affiliated members. Of note, 11 centers are members of both networks. Statistical analysis was performed with Excel and R. RESULTS: The overall response rate was 44% (55/124); 26 centers follow RPE65 biallelic mutation-associated IRD patients. By June 2021, 8/26 centers have treated 57 RPE65-IRD cases (1-19/center, median 6) and 43 planned for treatment (range 0-10/center, median 6). The overall age range was 3-52 years, and on average 22% of the patients did not (yet) qualify for treatment (range 2-60%/center, median 15%). Main reasons were too advanced (range 0-100, median 75%) or mild disease (range 0-100, median 0). Eighty-three percent of centers (10/12) that follow RPE65 mutation-associated IRD patients treated with VN participate in the PERCEIVE registry (EUPAS31153, http://www.encepp.eu/encepp/viewResource.htm?id=37005). Quality of life and full-field stimulus test improvements had the highest scores of the survey-reported outcome parameters in VN treatment follow-up. CONCLUSION: This second multinational survey on management of RPE65-IRD by EVICR.net centers and ERN-EYE HCPs in Europe indicates that RPE65-IRD might be diagnosed more reliably in 2021 compared to 2019. By June 2021, 8/26 centers reported detailed results including VN treatment. Main reasons for non-treatment were too advanced or mild disease, followed by absence of 2 class 4 or 5 mutations on both alleles or because of a too young age. Patient satisfaction with treatment was estimated to be high by 50% of the centers.

Grafting Hypercrosslinked Polymers on TiO2 Surface for Anchoring Ultrafine Pd Nanoparticles: Dramatically Enhanced Efficiency and Selectivity toward Photocatalytic Reduction of CO2 to CH4.

Metal deposition with photocatalyst is a promising way to surmount the restriction of fast e- /h+ recombination to improve the photocatalytic performance. However, the improvement remains limited by the existing strategies adopted for depositing metal particles due to the serious aggregation and large unconnected area on photocatalyst surface. Here, a strategy is proposed by directly grafting hypercrosslinked polymers (HCPs) on TiO2 surface to construct Pd-HCPs-TiO2 composite with uniform dispersion of ultrafine Pd nanoparticles on HCPs surface. This composite with surface area of 373 m2 g-1 exhibits improved photocatalytic CO2 conversion efficiency to CH4 with an evolution rate of 237.4 µmol g-1 h-1 and selectivity of more than 99.9%. The enhancement can be ascribed to the grafted porous HCPs with high surface area and N heteroatom on TiO2 surface for the stabilization of Pd nanoparticles, favoring the electron transfer and CO2 adsorption for selective CH4 production. This strategy may hold the promise for design and construction of porous organic polymer with semiconductor for efficient photocatalytic conversion.

Evaluating the efficacy of immobilized metal affinity chromatography (IMAC) for host cell protein (HCP) removal from anti-HER2 scFv expressed in Escherichia coli.

Host cell proteins (HCPs) are process-related impurities that have influence on product safety and efficacy. HCPs should effectively be removed by chromatographic steps in downstream purification process. In this study, we aimed to evaluate the efficacy of immobilized-metal affinity chromatography (IMAC) for separation of HCPs from anti-HER2 single chain fragment variable (scFv) expressed in E. coli. This study explored how different purification conditions including native, denaturing and hybrid affect HCP level in purified anti-HER2 scFv. Furthermore, the effects of NaCl concentration in wash buffer as well as imidazole concentration in wash and elution buffer on purification yield and HCP level in purified anti-HER2 scFv were evaluated. It was found that increasing imidazole concentration in wash and elution buffers in native conditions reduced the yield of anti-HER2 scFv purification. However, enhancing NaCl concentration in wash buffer in purification under native conditions led to significant increase in the amount of anti-HER2 scFv without any change in protein purity. Herein, none of the IMAC purification methods conducted on soluble cytoplasmic proteins under native conditions could reduce the amount of HCP to acceptable level. HCP content was only lowered to ˂ 10 ppm when inclusion bodies were purified under hybrid conditions. Furthermore, increasing imidazole concentration in wash buffer in purification under hybrid conditions led to significant increase in eluted anti-HER2 scFv concentration, while HCP content was also increased in this condition. Overall, purification under hybrid conditions using wash buffer containing 40 mM imidazole resulted in the highest yield and acceptable level of HCP.

Occupational stress, burnout, and organizational readiness for change: A longitudinal study among HIV HCPs in China.

Literature suggests that organizational readiness for change (ORC) could facilitate adaptation and implementation of new projects or practices in clinical settings. Limited data are available regarding the longitudinal associations between ORC and psychosocial conditions of HCPs. Using six waves of longitudinal data collected between 2013 and 2016 from 357 HIV HCPs in Guangxi, China, we identify sociodemographic and occupational characteristics that impact ORC and examine how occupational stress and burnout affect ORC adjusting for potential cofounders. A mixed effect model was used to assess the associations of ORC with psychosocial variables controlling for key background variables, and within-cluster and within-subject correlation over time. The ORC level was stable over time. Ethnical minority HCPs reported lower ORC compared with those of Han ethnicity. HCPs with administrative responsibility reported significantly lower ORC compared with the ones without administrative responsibility. HCPs with high school education attainment showed lower ORC compared to those with some college education. The ORC level was negatively associated with occupational stress and burnout controlling all the background variables. It is important to integrate reducing stress and alleviating burnout in the workplace into efforts to promote the acceptance and adaptation of new intervention.

Epidemiology, virology and clinical aspects of hantavirus infections: an overview.

At the end of 2019 and 2020s, a wave of coronavirus disease 19 (COVID-19) epidemics worldwide has catalyzed a new era of 'communicable infectious diseases'. However, the world is not currently prepared to deal with the growing burden of COVID-19, with the unexpected arrival of Hantavirus infection heading to the next several healthcare emergencies in public. Hantavirus is a significant class of zoonotic pathogens of negative-sense single-stranded ribonucleic acid (RNA). Hemorrhagic renal syndrome (HFRS) and hantavirus cardiopulmonary syndrome (HCPS) are the two major clinical manifestations. Till date, there is no effective treatments or vaccines available, public awareness and precautionary measures can help to reduce the spread of hantavirus disease. In this study, we outline the epidemiology, virology, clinical aspects, and existing HFRS and HCPS management approaches. This review will give an understanding of virus-host interactions and will help for the early preparation and effective handling of further outbreaks in an ever-changing environment.

Optimized Sample Preparation and Data Processing of Data-Independent Acquisition Methods for the Robust Quantification of Trace-Level Host Cell Protein Impurities in Antibody Drug Products.

Host cell proteins (HCPs) are a major class of bioprocess-related impurities generated by the host organism and are generally present at low levels in purified biopharmaceutical products. The monitoring of these impurities is identified as an important critical quality attribute of monoclonal antibody (mAb) formulations not only due to the potential risk for the product stability and efficacy but also concerns linked to the immunogenicity of some of them. While overall HCP levels are usually monitored by enzyme-linked immunosorbent assay (ELISA), mass spectrometry (MS)-based approaches have been emerging as powerful and promising alternatives providing qualitative and quantitative information. However, a major challenge for liquid chromatography (LC)-MS-based methods is to deal with the wide dynamic range of drug products and the extreme sensitivity required to detect trace-level HCPs. In this study, we developed powerful and reproducible MS-based analytical workflows coupling optimized and efficient sample preparations, the library-free data-independent acquisition (DIA) method, and stringent validation criteria. The performances of several preparation protocols and DIA versus classical data-dependent acquisition (DDA) were evaluated using a series of four commercially available drug products. Depending on the selected protocols, the user has access to different information: on the one hand, a deep profiling of tens of identified HCPs and on the other hand, accurate and reproducible (coefficients of variation (CVs) < 12%) quantification of major HCPs. Overall, a final global HCP amount of a few tens of ng/mg mAb in these mAb samples was measured, while reaching a sensitivity down to the sub-ng/mg mAb level. Thus, this straightforward and robust approach can be intended as a routine quality control for any drug product analysis.

"High-risk" host cell proteins (HCPs): A multi-company collaborative view.

Host cell proteins (HCPs) are process-related impurities that may copurify with biopharmaceutical drug products. Within this class of impurities there are some that are more problematic. These problematic HCPs can be considered high-risk and can include those that are immunogenic, biologically active, or enzymatically active with the potential to degrade either product molecules or excipients used in formulation. Some have been shown to be difficult to remove by purification. Why should the biopharmaceutical industry worry about these high-risk HCPs? What approach could be taken to understand the origin of its copurification and address these high-risk HCPs? To answer these questions, the BioPhorum Development Group HCP Workstream initiated a collaboration among its 26-company team with the goal of industry alignment around high-risk HCPs. The information gathered through literature searches, company experiences, and surveys were used to compile a list of frequently seen problematic/high-risk HCPs. These high-risk HCPs were further classified based on their potential impact into different risk categories. A step-by-step recommendation is provided for establishing a comprehensive control strategy based on risk assessments for monitoring and/or eliminating the known impurity from the process that would be beneficial to the biopharmaceutical industry.

Targeted CHO cell engineering approaches can reduce HCP-related enzymatic degradation and improve mAb product quality.

Host cell proteins (HCP) that co-purify with biologics produced in Chinese hamster ovary cells have been shown to impact product quality through proteolytic degradation of recombinant proteins, leading to potential product losses. Several problematic HCPs can remain in the final product even after extensive purification. Each recombinant cell line has a unique HCP profile that can be determined by numerous upstream and downstream factors, including clonal variation and the protein sequence of the expressed therapeutic molecule. Here, we worked with recombinant cell lines with high levels of copurifying HCPs, and showed that in those cell lines even modest downregulation (≤50%) of the difficult to remove HCP Cathepsin D, through stable short hairpin RNA interference or monoallelic deletion of the target gene using CRISPR-Cas9, is sufficient to greatly reduce levels of co-purifying HCP as measured by high throughput targeted LC-MS. This reduction led to improved product quality by reducing fragmentation of the drug product in forced degradation studies to negligible levels. We also show the potential of cell engineering to target other undesired HCPs and relieve the burden on downstream purification.

Sensitive, Rapid, Robust, and Reproducible Workflow for Host Cell Protein Profiling in Biopharmaceutical Process Development.

There is a growing industry and regulatory need to detect host cell protein (HCP) impurities in the production of protein biopharmaceuticals, as certain HCPs can impact product stability, safety, and efficacy, even at low levels. In some cases, regulatory agencies require the identification and the quantification of HCPs in drug products (DPs) for risk assessment, and this is an active and growing topic of conversation in the industry and amongst regulators. In this study, we developed a sensitive, robust, and reproducible workflow for HCP detection and quantification in a significantly shorter turnaround time than that previously reported using an Evosep ONE LC system coupled to an Orbitrap Fusion Lumos mass spectrometer. Because of its fast turnaround time, this HCP workflow can be integrated into process development for the high-throughput (60 samples analyzed per day) identification of HCPs. The ability to rapidly measure HCPs and follow their clearance throughout the downstream process can be used to pinpoint sources of HCP contamination, which can be used to optimize biopharmaceutical production to minimize HCP levels. Analysis of the NIST monoclonal antibody reference material using the rapid HCP profiling workflow detected the largest number of HCPs reported to date, underscoring an improvement in performance along with an increased throughput. The HCP workflow can be readily implemented and adapted for different purposes to guide biopharmaceutical process development and enable better risk assessment of HCPs in drug substances and DPs.

Do gay and bisexual men who conceal their same-sex behavior prefer different kinds of health services? Findings across four cities to inform client-centered HIV prevention in China.

BACKGROUND: In China, addressing disparities in the HIV epidemic among men who have sex with men (MSM) requires targeted efforts to increase their engagement and retention in prevention. In an effort to advance MSM-friendly HIV services within China, and informed by community-based partnerships, we tested whether MSM who have ever versus never disclosed their same-sex behavior to healthcare providers (HCP) differ in sociodemographic and behavioral characteristics as well as the qualities of sexual health services each group would prefer to access. METHODS: We conducted a cross-sectional survey among HIV-negative MSM who went to MSM-focused voluntary counseling and testing clinics in four cities in China. The survey was anonymous and collected information on sociodemographic characteristics, testing behaviors, sexual-health related behavior, and sexual health service model preferences. RESULTS: Of 357 respondents, 68.1% participants had ever disclosed same-sex behavior to HCPs when seeking advice for sexual health. Younger age (aOR = 1.04; 95% CI: 1.01-1.08), and worry of HIV acquisition (aOR = 1.39; 95% CI: 1.05-1.84) were associated with higher odds of past disclosure. The availability of comprehensive sexual health services was one of the most valued characteristics of the ideal sexual health clinic. Those who ever disclosed and never disclosed differed significantly in their ranking of the importance of three out of ten dimensions: sexual health counseling services available (M = 3.99 vs. M = 3.65, p = .002), gay identity support available (M = 3.91 vs. M = 3.62, p = .016) and clinic collaborates with a gay CBO (M = 3.81 vs. M = 3.56, p = .036). CONCLUSIONS: Our hypothesis that MSM who had disclosed versus never disclosed same-sex behavior would differ in the value they placed on different dimensions of sexual health service was partially borne out. As health authorities in China decide on implementation models for pre-exposure prophylaxis (PrEP) delivery and specifically within which institutions to integrate PrEP services, the preferences of target populations should be considered to develop comprehensive, patient-centric and LGBT-friendly services.

Clinical Characteristics of Ratborne Seoul Hantavirus Disease.

Although Seoul orthohantavirus is the only globally spread hantavirus pathogen, few confirmed human infections with this virus have been reported in Western countries, suggesting lower medical awareness of the milder, transient, and often chameleon-like symptoms of this zoonosis. We describe lesser known clinical and laboratory characteristics to help improve underreporting of this virus.

The application of caprylic acid in downstream processing of monoclonal antibodies.

Caprylic acid (CA), a naturally occurring eight-carbon fatty acid, has long been used as albumin stabilizer, non-IgG fraction precipitant and bactericidal agent in pharmaceutical industry. The mechanisms through which CA achieves its effects have been correlated with the molecule's protein/lipid binding capacity conferred by its octyl moiety. This article, following an initial review of CA's historical applications, introduces CA's relatively new application in downstream processing of monoclonal antibodies (mAbs). By taking advantage of CA mediated impurity precipitation and virus inactivation, it might be possible to develop a two-column purification process in replacement of the standard three-column process without compromising product quality.

Shared decision making and experiences of patients with long-term conditions: has anything changed?

BACKGROUND: Medication problems among patients with long-term conditions (LTCs) are well documented. Measures to support LTC management include: medicine optimisation services by community pharmacists such as the Medicine Use Review (MUR) service in England, implementation of shared decision making (SDM), and the availability of rapid access clinics in primary care. This study aimed to investigate the experience of patients with LTCs about SDM including medication counselling and their awareness of community pharmacy medication review services. METHODS: A mixed research method with a purposive sampling strategy to recruit patients was used. The quantitative phase involved two surveys, each requiring a sample size of 319. The first was related to SDM experience and the second to medication counselling at discharge. Patients were recruited from medical wards at St. George's and Croydon University Hospitals.The qualitative phase involved semi-structured interviews with 18 respiratory patients attending a community rapid access clinic. Interviews were audio-recorded and transcribed verbatim. Thematic analysis using inductive/deductive approaches was employed. Survey results were analysed using descriptive statistics. RESULTS: The response rate for surveys 1 and 2 survey was 79% (n = 357/450) and 68.5% (240/350) respectively. Survey 1 showed that although 70% of patients had changes made to their medications, only 40% were consulted about them and two-thirds (62.2%) wanted to be involved in SDM. In survey 2, 37.5% of patients thought that medication counselling could be improved. Most patients (88.8%) were interested in receiving the MUR service; however 83% were not aware of it. The majority (57.9%) were interested in receiving their discharge medications from community pharmacies. The interviews generated three themes; lack of patient-centered care and SDM, minimal medication counselling provided and lack of awareness about the MUR service. CONCLUSION: Although patients wanted to take part in SDM, yet SDM and medication counselling are not optimally provided. Patients were interested in the MUR service; however there was lack of awareness and referral for this service. The results propose community pharmacy as a new care pathway for medication supply and counselling post discharge. This promotes a change of health policy whereby community-based services are used to enhance the performance of acute hospitals.

Prediction of Pan-Specific B-Cell Epitopes From Nucleocapsid Protein of Hantaviruses Causing Hantavirus Cardiopulmonary Syndrome.

Hantaviruses are emerging viral pathogens that causes hantavirus cardiopulmonary syndrome (HCPS) in the Americas, a severe, sometimes fatal, respiratory disease in humans with a case fatality rate of ≥50%. IgM and IgG-based serological detection methods are the most common approaches used for laboratory diagnosis of hantaviruses. Such emerging viral pathogens emphasizes the need for improved rapid diagnostic devices and vaccines incorporating pan-specific epitopes of genotypes. We predicted linear B-cell epitopes for hantaviruses that are specific to genotypes causing HCPS in humans using in silico prediction servers. We modeled the Andes and Sin Nombre hantavirus nucleocapsid protein to locate the identified epitopes. Based on the mean percent prediction probability score, epitope IMASKSVGS/TAEEKLKKKSAF was identified as the best candidate B-cell epitope specific for hantaviruses causing HCPS. Promiscuous epitopes were identified in the C-terminal of the protein. Our study for the first time has reported pan-specific B-cell epitopes for developing immunoassays in the detection of antibodies to hantaviruses causing HCPS. Identification of epitopes with pan-specific recognition of all genotypes causing HCPS could be valuable for the development of immunodiagnositic tools toward pan-detection of hantavirus antibodies in ELISA. J. Cell. Biochem. 118: 2320-2324, 2017. © 2017 Wiley Periodicals, Inc.

Effective strategies for host cell protein clearance in downstream processing of monoclonal antibodies and Fc-fusion proteins.

Recombinant therapeutic proteins are typically produced through cell culture process. Host cell proteins (HCPs) are endogenous proteins derived from the host cells used for such bioproduction. HCPs form a major class of process-related impurities and even at low levels they can potentially compromise the safety and efficacy of biopharmaceuticals. Therefore, they need to be adequately removed via the downstream process. HCPs are complex mixtures with diverse physiochemical properties, and certain subpopulations can bind to the intended product. Hence reducing them to the generally accepted level can be challenging. This article reviews effective HCP removing strategies at different stages of downstream process for monoclonal antibodies and Fc-fusion proteins. When used in combination, these strategies can greatly enhance the chance of meeting the drug substance specifications for residual HCP.

Healthcare professionals' and parents' experiences of the confirmatory testing period: a qualitative study of the UK expanded newborn screening pilot.

BACKGROUND: With further expansion of the number of conditions for which newborn screening can be undertaken, it is timely to consider the impact of positive screening results and the confirmatory testing period on the families involved. This study was undertaken as part of a larger programme of work to evaluate the Expanded Newborn Screening (ENBS) programme in the United Kingdom (UK). It was aimed to determine the views and experiences of healthcare professionals (HCPs) and parents on communication and interaction during the period of confirmatory testing following a positive screening result. METHODS: Semi-structured interviews were undertaken with parents of children who had received a positive ENBS result and HCPs who had been involved with the diagnosis and support of parents. Ten parents and 11 healthcare professionals took part in the in-depth interviews. Questions considered the journey from the positive screening result through confirmatory testing to a confirmed diagnosis and the communication and interaction between the parents and HCPs that they had been experienced. Key themes were identified through thematic analysis. RESULTS: The results point to a number of elements within the path through confirmatory testing that are difficult for parents and could be further developed to improve the experience. These include the way in which the results are communicated to parents, rapid turnaround of results, offering a consistent approach, exploring interventions to support family relationships and reviewing the workload and scheduling implications for healthcare professionals. CONCLUSIONS: As technology enables newborn screening of a larger number of conditions, there is an increasing need to consider and mediate the potentially negative effects on families. The findings from this study point to a number of elements within the path through confirmatory testing that are difficult for parents and could be further developed to benefit the family experience.