Patient Access Research Articles

A new digital model for Italian Integrated Home Care: strengths, barriers, and future implications

Abstract Issue/Problem After the COVID-19 pandemic, Italy’s National Health Service (NHS) is transforming by adopting telemedicine through its National Recovery and Resilience Plan, aiming to modernize healthcare delivery and ensure equity. In this plan Territorial Coordination Centers (COT) were designed to improve patient access and continuity of care. However, regulatory challenges hinder the widespread adoption of telemedicine. Our work describes the technical, structural, and operational aspects of the new Italian Integrated Home Care (IHC) digital model, addressing strengths, barriers, and future implications. Description of the problem The implementation of the IHC digital model faces multiple challenges. Italy’s poor technical infrastructure, especially in rural areas, hampers access to critical services. Resistance to change among rural systems and the elderly, coupled with low digital literacy, inhibits telemedicine adoption. Fragmentation in the NHS leads to resource disparities, particularly disadvantaging southern regions. Italy also grapples with a severe shortage of healthcare professionals, posing a threat to the model’s sustainability. Results The National Digital Health Agency enacts the IHC model by overseeing telemedicine services through a cloud-based protocol. Each Region provides “Basic Telemedicine Services”: healthcare professionals’ and patient teleconsultation, telemonitoring, teleassistance. Communication between services, infrastructures, and local health authorities is facilitated by a modular interoperability layer, ensuring data standards and quality. A national telemedicine dissemination portal will contain data on all telemedicine solutions provided. Lessons Clear communication is essential for telemedicine acceptance. COTs enhance coordination and management. Bridging the technology gap for disadvantaged groups, supporting frontline employees and addressing adoption factors is vital to overcome the challenges faced. Key messages • The National Digital Health Agency drives telemedicine services under the IHC model. Each region offers Basic Telemedicine Services, ensuring data standards, quality and interoperability of data. • Italy’s telemedicine adoption faces poor infrastructure, resistance and workforce shortages. Focusing on equity, healthcare workers support and bridging the technology gap will be key.

Awareness and knowledge about Female Genital Schistosomiasis among European healthcare workers

Abstract Background Female Genital Schistosomiasis (FGS) is a gynaecological manifestation of persistent infection with Schistosoma haematobium, which can lead to severe consequences, such as miscarriage and infertility. It is estimated to affect 56 million women globally, mostly in sub-Saharan Africa (SSA). Most migrants in Europe are female, often from SSA and therefore at risk of FGS, hence healthcare workers (HCWs) knowledge of FGS is essential for the provision of adequate care. This study aims to assess awareness and knowledge of FGS among European HCWs to inform strategies to improve the management of migrant health. Methods In June 2023 - January 2024 we conducted a cross-sectional online survey targeting medical doctors (MDs), nurses and midwives (NMs) working in fields of infectiology, gynaecology, urology, family, travel, internal or occupational medicine. The prevalence of FGS awareness and knowledge was estimated, Poisson regression was used to identify factors associated with MDs’ awareness of FGS. Results Among 922 surveyed HCWs, 43.7% (CI95%: 39.6-47.9) of MDs and 12.0% (CI95%: 8.8-16.0) NMs have heard about FGS. FGS awareness among MDs was associated with work in clinics for migrants (prevalence ratio (PR)=1.33, CI95%: 1.10-1.59) and specialization, being lower for gynaecology (PR = 0.67; CI95%:0.51-0.88), and family medicine (PR = 0.42, CI95%:0.30-0.59). Among MDs, 7.1% (CI95%: 5.1- 9.5) had medium knowledge, while 25.3% (CI95%: 21.8-29.0) had low, and 67.6% (CI95%: 63.7-71.4) no knowledge on symptoms, complications or diagnostic tools for FGS. FGS knowledge was mostly acquired through academic curricula (34.7%), scientific literature (28.4%) and conferences (25.6%). Conclusions The study shows limited awareness of FGS among European MDs and NMs, and highlights that European HCWs may not be adequately prepared to deal with diseases that are gaining relevance on the European continent due to the global connectivity and the dynamic nature of our societies. Key messages • In Europe, the health specialities that are the first point of patient access to the health system show a low level of awareness and knowledge of Female Genital Schistosomiasis. • Rising knowledge of FGS among European HCWs through academic curricula and continuous medical education is important to ensure adequate diagnosis and management of disease in migrant populations.

Traceability for strengthening supply chain systems and enhancing real-time visibility: Focus of NAFDAC on advancing vaccine traceability in Nigeria

This study explores the successful implementation of activities aimed at scaling traceability for COVID-19 and routine immunization (RI) vaccines to the local government area and selected healthcare facilities in Nigeria, funded by the Bill and Melinda Gates Foundation. The study was executed by the National Agency for Food and Drug Administration and Control (NAFDAC) and sought to enhance supply chain systems by deploying advanced traceability mechanisms and ensuring real-time stock visibility. The article discusses the accomplishments, challenges, and regulatory framework of NAFDAC, emphasizing GS1 technology-driven traceability, and presents the results of the field scanning activities conducted in July 2023. The approach involved a phased public sector pilot, showcasing the feasibility and challenges of tracking vaccine movement through the supply chain. The result shows the detection of 43 unique products across 1022 facilities from a total of 110,113 scans, offering valuable insights into vaccine distributions. The strategic goals of the project aligned with developing safety surveillance systems in low- and middle-income countries (LMICs) to facilitate patient access to global health products. Similarly, significant improvement in traceability through automated data capture (barcode scanning) and expanded coverage for COVID-19 and selected RI vaccines in Nigeria was found. Against this background, the information derived from this report will build confidence in patients regarding vaccine authenticity, establish a transparent and robust supply chain, and foster pharmacovigilance capability through integration with the track-and-trace systems. Thus, the study provides invaluable insights and opportunities for global health practitioners, policymakers, and researchers to incorporate track-and-trace into regulatory systems by other national regulatory authorities.

Introducing online narrated video animations to facilitate patients' understanding of cardiac procedures in a high-volume tertiary centre

Abstract Introduction Discussions about the benefits and risks of invasive procedures, including their alternatives, are an integral part of certain patient consultations in Cardiology. However, patients absorb only a fraction of the information shared during a single encounter, often due to time constraints, leading to an incomplete understanding. Video animation tools were designed to better facilitate communication and consolidate patient (and family members) understanding in advance of their procedure. Purpose We are a high-volume tertiary cardiac centre, and we aimed to assess real-world patient feedback having introduced an online cardiac video animation tool into our organisation. Methods In July 2022, we obtained unlimited patient access to a digital tool that offers short, multi-language narrated video animations covering the breadth of cardiac procedures (cardiac intervention, electrophysiology, structural and cardiac surgery). It is accessible on any device, including a desktop, laptop, or mobile phone. Specifically, we purchased password protected access to 31 video animations in three local languages. Web-links and QR codes for each video animation were designed. These were shared with patients and family members during different stages of the patients’ journey through the hospital. We sampled qualitative feedback from a cohort of patients attending pre-assessment clinic, measured on our electronic patient record via a 3-point Likert scale. Results As illustrated in Figure 1, we adapted our patient pathway to integrate use of this resource in the patient journey by 1) notifying patients during their out-patient cardiologist consultation; 2) emailing video links integrated within an e-consent process; 3) introducing video links as QR codes in patient letters; 4) reminding patients during their nurse-led pre-assessment clinic; 5) via hospital poster advertisements; 6) and on the front page of the hospital website. Since its introduction 18 months ago, 20,607 animation views have occurred, with 90% watched to completion. The three most popular animations were "angiogram/angioplasty" (4135), atrial fibrillation ablation (1415), and TAVI (1243). From July 2022 to December 2023, 1,878 patients have attended our nurse led pre-assessment clinic, and we sampled qualitative feedback from about 20% (342 patients). As demonstrated in Figure 2, 84% of patients felt the procedural video animations were quite helpful/very helpful. The remaining 16% found it "not helpful", with anecdotal reasons being "inability to access the technology", "feeling already adequately informed", or "not wanting to know". Conclusion In our high-volume tertiary centre, online narrated video animations discussing cardiac procedures were successfully implemented into our patient pathway and deemed helpful by the majority of our patients.Fig1.Process map of the patient journeyFig2.Patients’ feedback regarding video

The relationship between post-anastomosis brachial artery flow rate and brachiocephalic arteriovenous fistula access maturity in end-stage kidney disease patients with diabetes mellitus

Background: From previous studies, evaluation of post-anastomosis draining-vein volume flow rate with Doppler ultrasound can be a predictor for arteriovenous fistula maturation. Due to the high variation in measurements by the effect of probe pressure in draining vein, measuring volume flow rate based on post-anastomosis feeding-artery may be an early alternative predictor of arteriovenous fistula maturation. This study aims to investigate the correlation of post-creation brachial artery volume flow rate on maturity of brachiocephalic arteriovenous fistula access in patients with end-stage kidney disease with diabetes mellitus. Methods: A retrospective cohort study was conducted on end-stage kidney disease patients with diabetes mellitus who underwent brachiocephalic arteriovenous fistula creation at three hospitals from July 2019 to March 2020. Doppler ultrasound examination of the brachial artery and draining vein volume flow rate was conducted at pre-operative, post-creation, 2 weeks, and 6 weeks post-creation. Maturity was evaluated at 6 weeks post-anastomosis. Results: A total of 71 subjects met the inclusion and exclusion criteria, with 44 (62%) achieving maturation within 6 weeks. There was a correlation between post-anastomosis brachial artery (p < 0.001) and draining vein volume flow rate (p < 0.001) with arteriovenous fistula maturity after 6 weeks post-operatively. Brachial artery volume flow rate of ⩾350 mL/min can predict AVF maturity with a sensitivity of 95.45% (95% confidence interval = 84.86–98.74) and a specificity of 85.19% (95% confidence interval = 67.52–94.08). Conclusion: Post-anastomosis brachial artery flow volume can be a valuable parameter to predict brachiocephalic arteriovenous fistula maturity. It is a potential alternative to draining vein volume flow, which is technically a difficult examination.

Arterio-Venous Fistula Calcifications—Risk Factors and Clinical Relevance

(1) Background: Arterio-venous fistulas (AVFs) are considered the gold-standard vascular access (VA) in patients on maintenance hemodialysis (HD) therapy. AVF calcifications represent a less studied VA related complication, even though HD patients are at a higher risk for extraosseous calcifications. The aim of this study is to assess the prevalence and risk factors of AVF calcifications, as well as the 5-year impact on AVF functionality and on overall mortality. (2) Methods: We conducted a 5-year prospective study including 161 patients on maintenance HD therapy. At baseline, we collected data related to VA history, comorbidities, demographics, subjective global assessment scale (SGA), and biochemical parameters. All patients underwent a complete AVF ultrasound and we recorded AVF blood flow and the presence of AVF calcifications, stenoses, and aneurysms. (3) Results: In our study, we found an AVF calcification prevalence of 39%. In a univariate analysis, we found that patients with AVF calcifications were associated with other AVF complications as well (stenoses, aneurysms), had longer AVF and HD vintage, as well as higher serum calcium and PTH values. In a multivariate analysis, we found that patients with a longer HD vintage and higher calcium values were independently associated with AVF calcifications. AVF calcifications did not affect 5-year fistula patency, nor were they associated with a higher mortality risk in our group of patients. (4) Conclusions: AVF calcifications were a frequent finding in our analysis, but their presence does not seem to affect the 5-year AVF patency.

Prior central venous catheter placement and age are associated with earlier intervention after permanent hemodialysis access creation.

Arteriovenous fistulas (AVFs) and grafts are essential for long-term hemodialysis access in patients with end-stage renal disease. However, complications and access failure often necessitate re-intervention. In this study, we aim to delineate the factors associated with earlier failure of permanent hemodialysis access warranting revision procedures. This retrospective study aimed to identify factors associated with increased revision rates in AVFs and arteriovenous grafts, using multivariate survival analysis. A cohort of 136 patients who underwent initial arteriovenous access creation between 2005 and 2022 was analyzed. Patient characteristics, including age, comorbidities, access type, and vascular anatomy, were extracted, and hazard ratios (HR) were calculated to identify independent predictors of needing revision. A total of 119 patients were included in the final cohort, with a mean age of 55.2 years. Over 40% of patients had a previous central venous catheter placement, while 15% had a previous AVF. The majority of procedures were performed on the left side (74%), and brachiocephalic fistulas were most commonly created (41%). Univariate and multivariate Cox regression revealed that age (adjusted HR = 1.02, p = 0.01) and prior central venous catheter placement (adjusted HR = 1.77, p = 0.01) were independent predictors of earlier revision, while other variables such as sex, hypertension, and diabetes did not show significant associations. Patients with prior central venous catheter placement had a 77% increased risk of revision, even when adjusted for confounders. Understanding predictors of successful long-term access outcomes can guide decision-making regarding access type and alternative strategies. In our cohort, increased age and prior central venous catheter placement are associated with a shorter time to failure of permanent hemodialysis access and an increased risk of needing revision.

Comparing Traditional and Newer Glaucoma Procedures by Physician Experience and Practice Location in the United States.

Analysis of CMS Physician Payment data found that physician certification year, degree of urbanization, and estimated income by zip code were significant in predicting the proportion of traditional glaucoma procedures performed by each provider in the United States. The prevalence of microinvasive glaucoma surgery (MIGS) compared to traditional procedures has been increasing in glaucoma management. It is important to understand whether the uptake of new glaucoma procedures is associated with aspects of the physician practice. In this cross-sectional study, data on glaucoma procedure distribution, degree of urbanization and physician certification in the United States were extracted from the 2019 Centers for Medicare & Medicaid Services (CMS) Physician Payment and American Board of Ophthalmology databases. The distribution of traditional and MIGS procedure numbers for metropolitan versus non-metropolitan providers were visualized with boxplots and statistically compared using Mann-Whitney U tests. We used two-dimensional histograms and regression analyses to assess the relationship between certification year and volume of traditional versus MIGS procedures. A multivariable linear regression model was created using certification year, rural-urban commuting area (RUCA) code, and estimated income by practice zip code to predict the number and proportion of each type of glaucoma procedure. This study included 2625 providers from the CMS physician payment data who performed only traditional procedures (n=370), MIGS procedures (n=1727), or both procedure types (n=528) in 2019. The median number of MIGS procedures performed by each provider was greater in non-metropolitan areas (31 vs. 29, P=0.015) while the proportion of traditional procedures performed by each provider was greater in metropolitan areas (0.24 vs. 0.08, P<0.001). Regression analysis showed a positive relationship between certification year and the proportion of traditional procedures performed by each provider (P<0.001). Multivariable regression models found that certification year, RUCA code, and estimated income of practice location were all significant predictors (P<0.02) of the proportion of traditional procedures performed by each provider. In the United States, physicians in metropolitan areas and more recent certification years are more likely to perform a larger proportion of traditional procedures. This finding suggests that the distribution of glaucoma procedure types is related to physician factors such as degree of urbanization and duration of practice. More research is needed to better understand how such differences affect patient access and outcomes.

Barriers and facilitators of healthcare access for long COVID-19 patients in a universal healthcare system: qualitative evidence from Austria

BackgroundLong COVID-19 challenges health and social systems globally. International research finds major inequalities in prevalence and healthcare utilization as patients describe difficulties with accessing health care. In order to improve long-term outcomes it is vital to understand any underlying access barriers, for which relevant evidence on long COVID-19 is thus far lacking in a universal healthcare system like Austria. This study aims to comprehensively identify access barriers and facilitators faced by long COVID-19 patients in Austria and explore potential socioeconomic and demographic drivers in health and social care access.MethodsApplying an exploratory qualitative approach, we conducted semi-structured interviews with 15 experts including medical professionals and senior health officials as well as focus groups with 18 patients with confirmed long COVID-19 diagnosis reflecting varying participant characteristics (age, gender, urbanicity, occupation, education, insurance status) (July-Nov 2023). Data were analysed following a thematic framework approach, drawing on a comprehensive ‘access to health care’ model.ResultsBased on expert and patient experiences, several access barriers and facilitators emerged along all dimensions of the model. Main themes included scepticism and stigma by medical professionals, difficulties in finding knowledgeable doctors, limited specialist capacities in the ambulatory care sector, long waiting times for specialist care, and limited statutory health insurance coverage of treatments resulting in high out-of-pocket payments. Patients experienced constant self-organization of their patient pathway as stressful, emphasizing the need for multidisciplinary care and centralized coordination. Facilitators included supportive social environments, telemedicine, and informal information provided by a nationwide patient-led support group. Differences in patient experiences emerged, among others, as women and younger patients faced gender- and age-based stigmatization. Complementary health insurance reduced the financial strain, however, did not ease capacity constraints, which were particularly challenging for those living in rural areas.ConclusionsThe findings of this study indicate a call for action to improve the long COVID-19 situation in Austria by empowering both providers and patients via increased information offerings, strengthened interdisciplinary treatment structures and telemedicine offerings as well as research funding. Our insights on potentially relevant socioeconomic and demographic drivers in access barriers lay the necessary foundation for future quantitative inequality research.

Potential for Harm in the Treatment of Pediatric Obsessive-Compulsive Disorder: Pitfalls and Best Practices.

Pediatric obsessive-compulsive disorder (OCD) can be debilitating and chronic unless treated early with efficacious intervention. The past several decades of intervention research have identified cognitive-behavioral therapy (CBT) with exposure and response/ritual prevention (ERP) as the first-line, evidence-based psychological intervention for pediatric OCD. Yet, many youths with OCD unfortunately remain inadequately treated. In well-meaning but misguided efforts to treat this complex disorder, clinicians holding misconceptions about ERP may fail to apply evidence-based treatments, misapply generic CBT techniques and ERP principles, or turn to non-evidence-based interventions. Potentially harmful treatments may worsen symptoms, while ineffective treatments can waste resources, impede patient access to efficacious treatment, and weaken public confidence in psychotherapy. The overarching goals of this review paper are to describe potentially harmful and ineffective practices in the treatment of pediatric OCD and to offer recommendations aligned with evidence-based practice. First, we dispel common misconceptions about ERP that may underlie its underuse among clinicians. We then describe potentially harmful and ineffective interventions for pediatric OCD, starting with misapplication of generic CBT techniques and ERP principles. We also identify non-evidence-based treatments for pediatric OCD that have limited conceptual or empirical foundations. Finally, we conclude with recommendations for clinicians who treat pediatric OCD, intervention researchers, training programs across mental health-related disciplines, and policymakers.

Recommendations for permanent sleep telehealth: an American Academy of Sleep Medicine position statement.

Telehealth use greatly expanded under the Centers for Medicare and Medicaid Services (CMS) waivers at the start of the COVID-19 pandemic; however, the uncertainty and limitations of continued coverage risks loss of this momentum. Permanent coverage with adequate reimbursement is essential for the long-term acceptance and expansion of telehealth services. Telehealth supports both the current and future need for sleep health management by expanding patient access, increasing clinician efficiency, improving patient safety, and addressing health care equity. Sleep medicine is an ideal field for telehealth due to limited provider access, safety concerns with sleepy patients, availability of remote patient monitoring for treatment management, and the minimal need for repeated physical examinations. Telehealth is non-inferior for delivery of cognitive behavioral therapy for insomnia (CBT-I) and can enhance obstructive sleep apnea (OSA) treatment adherence. It is the position of the American Academy of Sleep Medicine (AASM) that telehealth is an essential tool for the provision of high quality, patient-centered care for patients with sleep disorders. We encourage all stakeholders including legislators, policymakers, clinicians, and patients to work together to address payment models, interstate care, technology access, prescribing practices, and ongoing research to ensure that sleep telehealth services are permanently available and accessible for all patients seeking sleep medicine care.

Simulated GP clinic closure: effects on patient access in the Irish Mid-West.

Rural communities can experience more barriers to accessing health care than their urban counterparts, largely due to fewer healthcare staff and services, and geographical isolation. The purpose of this study is to examine the availability of GP practices in rural communities across the Mid-West of Ireland and the potential impact of practice closure on patient access. GP clinic locations were identified in Ireland's Mid-West, specifically counties Limerick and Clare. Administrative subdivisions of both counties, Small Areas (SAs), were identified and their XY geographic centre coordinates recorded. SAs were indexed into six levels of rurality according to Irish Central Statistics Office urban/rural classifications (1, cities; 2, satellite urban towns; 3, independent urban towns; 4, rural areas with high urban influence; 5, rural areas with moderate urban influence; 6, highly rural/remote areas). The direct linear distance from the centre of each SA to its respective closest GP clinic was calculated. Simulated closure of each GP clinic was assessed programmatically by removing practices from the overall dataset and calculating the new direct linear distance from each SA to the next closest GP clinic. The majority of the SAs in County Clare (63%) and County Limerick (66%) are classified as rural (rurality index &ge;4), with the exception of Limerick City, where all SAs were defined as urban. Rural SAs have longer travel distances to GP clinics than their urban counterparts, and these distances are greater with increasing rurality of a population. Simulated closure of GP clinics revealed increasing travel distances to the next closest clinic with increasing level of rurality in a stepwise fashion (r2=0.31). Rural community dwellers across the Mid-West of Ireland face longer travel distances to GP clinics than their urban counterparts. Thus rural communities will be, on average, more adversely affected should their local GP clinic close. While these findings are unsurprising, our methodology calculates a discrete number that can be used to rank vulnerability of local communities. Rural areas are particularly vulnerable to GP clinic closure, and maintaining a solid foundation of primary care in these areas will require careful service and workforce planning.

A qualitative study of pelvic health physiotherapists’ experiences of non-medical prescribing in the UK

The Department of Health promoted non-medical prescribing (NMP) to improve patient access to medicine, enhance public health and recognize the expertise of healthcare professionals. Pelvic health physiotherapists (PHPs) can optimize NMP for those with pelvic floor conditions. It is pertinent to understand the experiences of this under-researched group in order to facilitate implementation. The aim of this study was to explore PHPs’ experiences of NMP in their clinical practice. Purposive sampling recruited five participants. A qualitative descriptive study was completed using one focus group and two semi-structured interviews. These were completed using video conferencing alongside a topic guide. Verbatim transcripts were checked and verified by the participants. The data were interpreted using thematic analysis. Three themes with associated subthemes were identified. The themes were: the perceived value of NMP; the impact of organizational governance on NMP; and the impact of self-efficacy on NMP. Recommendations to improve implementation in practice that could be considered included: adequate managerial provision for NMP training; national governance development; peer support; prescription funding; speciality-specific continuing professional development; further pharmacology training for physiotherapists; and easy access to patient information. Further research into the clinical and economic impact of NMP that involves a larger pool of participants will: improve data quality and rigour; confirm results; and provide further recommendations.

Doctors as Device Manufacturers? Regulation of Clinician-Generated Innovation in the ICU.

Critical care physicians are rich sources of innovation, developing new diagnostic, prognostic, and treatment tools they deploy in clinical practice, including novel software-based tools. Many of these tools are validated and promise to actively help patients, but physicians may be unlikely to distribute, implement, or share them with other centers noncommercially because of unsettled ethical, regulatory, or medicolegal concerns. This Viewpoint explores the potential barriers and risks critical care physicians face in disseminating device-related innovations for noncommercial purposes and proposes a framework for risk-based evaluation to foster clear pathways to safeguard equitable patient access and responsible implementation of clinician-generated technological innovations in critical care.

Promoting Equitable and Affordable Patient Access to Safe and Effective Innovations in Donation and Transplantation of Substances of Human Origin and Derived Therapies.

Innovation is a hallmark of organ, tissue, and cell transplantation. The development of new treatments derived from these substances of human origin (SoHO) has rapidly evolved in recent years. Despite the great benefits that these innovative therapies could bring to patients, significant difficulties have arisen in making them equitably and widely accessible. Herein, we identify and address 4 challenges to promote innovation in this field in a collaborative, sustainable, and transparent manner and propose some concrete solutions applicable to SoHO-derived treatments, ranging from cell therapies to solid organ transplantation. Regulators, health policymakers, and government officials are recommended to incorporate specific elements into the regulatory frameworks of their respective jurisdictions, although regulatory convergence and equivalent quality and safety standards applicable to SoHO at a global level would be needed. An innovation-driven regulatory environment, respectful with the human origin and in accordance with the altruistic donation of SoHO, should be encouraged to improve the safety, effectiveness, accessibility, and affordability of SoHO and to promote collaboration between countries and between public and private sectors. This overview is the outcome of a working group focused on "Innovation in the donation and clinical application of SoHO" as part of the international Summit "Towards Global Convergence in Transplantation: Sufficiency, Transparency and Oversight" convened by the Organización Nacional de Trasplantes under the Spanish Presidency of the Council of the European Union in November 2023 and cosponsored by the Council of Europe, the World Health Organization, the Transplantation Society, and the European Society for Organ Transplantation.

Sodium zirconium cyclosilicate treatment and rates of emergency interventions for hyperkalaemia: a propensity-score weighted case-control study

Abstract Background Sodium zirconium cyclosilicate (SZC) reduces serum potassium in patients with chronic hyperkalaemia in clinical trials, but its role in the emergency treatment of hyperkalaemia is unproven. We hypothesised that SZC use for emergent hyperkalaemia would be associated with a reduction in rates of emergency interventions for hyperkalaemia. Methods This was a single centre, propensity-score weighted case-control study of patients admitted with hyperkalaemia to a specialist renal centre. We randomly selected 250 patients admitted between April 2021 and September 2022 (post-SZC era) with a potassium ≥ 5.5 mmol/L treated with at least one ≥ 10g dose of SZC (treatment group). We randomly selected a comparator group of 250 patients admitted between January 2018 and December 2019 (pre-SZC era) with a potassium ≥ 5.5 mmol/L (control group). Baseline demographic and clinical characteristics were recorded and used as covariates for propensity scoring (PS) and inverse probability treatment weighting (IPTW). Our primary outcome measure, rates of emergency haemodialysis, were tested using unadjusted models and multivariable logistic regression models on unweighted data in addition to unadjusted models on weighted data. We also reviewed rates of emergency temporary central venous access as a secondary outcome. Results 59% were male, the mean age was 67 (SD 14) years and 149 (30%) were receiving maintenance dialysis. IPTW achieved satisfactory balance of covariates between the treatment and control groups. In the treatment group, patients were 77% less likely to need emergency haemodialysis (OR 0.23; CI 0.17 to 0.31); this result was consistent following analysis of weighted and unweighted data. Similarly, patients treated with SZC were 73% less likely to require emergency temporary central venous access (OR 0.27; CI 0.20–0.36). Conclusion SZC was associated with signification reduction in rates of emergency haemodialysis and emergency temporary central venous access in patients admitted to a specialised renal centre with emergent hyperkalaemia.

Implementation of the Medicinal Cannabis Scheme in New Zealand: six emerging trends.

To evaluate the implementation of the New Zealand Medicinal Cannabis Scheme (MCS), including how products, prices, prescribing and patient access have evolved since 2020. Analysis of administrative data obtained via Official Information Act (OIA) requests and publicly available information on products and prices. Six emerging trends were identified: 1) quarterly supply of medicinal cannabis products has increased fourteenfold since the implementation of the Scheme in 2020, 2) most products are now THC-dominant rather than CBD, 3) most products are in the form of dried cannabis flower rather than oral liquids/oils, 4) prices of products have declined to be comparable to the illegal market, 5) specialised private cannabis clinics have expanded patient access, and 6) inequities persist due to expense, and disproportionately affect Māori and those on lower incomes. The New Zealand MCS successfully established a domestic medicinal cannabis production sector, reduced prices and expanded the range of products to provide alternatives to illegal supply. It has also inadvertently created the conditions for the emergence of specialised cannabis clinics that have enhanced access. However, the increasing supply of THC-dominant and flower products, and the privatisation of prescribing via cannabis clinics, may have unintended negative consequences.

A study of implementation factors for a novel approach to clinical trials: constructs for consideration in the coordination of direct-to-patient online-based medical research

BackgroundTraditional medical research infrastructures relying on the Centers of Excellence (CoE) model (an infrastructure or shared facility providing high standards of research excellence and resources to advance scientific knowledge) are often limited by geographic reach regarding patient accessibility, presenting challenges for study recruitment and accrual. Thus, the development of novel, patient-centered (PC) strategies (e.g., the use of online technologies) to support recruitment and streamline study procedures are necessary. This research focused on an implementation evaluation of a design innovation with implementation outcomes as communicated by study staff and patients for CoE and PC approaches for a randomized controlled trial (RCT) for patients with vasculitis.MethodsIn-depth qualitative interviews were conducted with 32 individuals (17 study team members, 15 patients). Transcripts were coded using the Consolidated Framework for Implementation Research (CFIR).ResultsThe following CFIR elements emerged: characteristics of the intervention, inner setting, characteristics of individuals, and process. From the staff perspective, the communication of the PC approach was a major challenge, but should have been used as an opportunity to identify one “point person” in charge of all communicative elements among the study team. Study staff from both arms were highly supportive of the PC approach and saw its promise, particularly regarding online consent procedures. Patients reported high self-efficacy in reference to the PC approach and utilization of online technologies. Local physicians were integral for making patients feel comfortable about participation in research studies.ConclusionsThe complexity of replicating the interpersonal nature of the CoE model in the virtual setting is substantial, meaning the PC approach should be viewed as a hybrid strategy that integrates online and face-to-face practices.Trial registrations1) Name: The Assessment of Prednisone In Remission Trial – Centers of Excellence Approach (TAPIR).Trial registration number: ClinicalTrials.gov NCT01940094.Date of registration: September 10, 2013.2) Name: The Assessment of Prednisone In Remission Trial – Patient Centric Approach (TAPIR).Trial registration number: Clinical Trials.gov NCT01933724.Date of registration: September 2, 2013.

Characteristics of Patients Utilizing Telemedicine in Hand and Upper-Extremity Surgery.

The impact of social determinants of health on patients' access to medical care and health outcomes is increasingly recognized. Telemedicine's rapid and widespread adoption altered the delivery of care. This study describes the characteristics of patients undergoing telemedicine visits with hand surgeons, without COVID-19 pandemic-related restrictions. All telemedicine encounters for 4 hand surgeons at a single institution between September 2022 and September 2023 were retrospectively reviewed. Patient demographics were recorded as well as the encounter type. The distance of the patients' residential address and the area deprivation index (ADI) were recorded. Sixty patient encounters were recorded. Forty-seven percent were male and 53% were female, 5 (8.3%) were new patients, 44 (73.3%) were established patients, and 11 (18.3%) were postoperative. The mean age was 43, and the mean and median distances from the clinic were 72 and 18 miles, respectively. Forty-three patients (72%) were from high ADI residences. Upon comparison of low ADI (0-50th percentile) and high ADI (50th-100th percentile) patients, no statistically significant differences in age, sex, distance from clinic, or encounter type were found. Telemedicine in hand surgery at this single institution is most frequently used for follow-up encounter types in patients living in high ADI communities, far from clinic sites. Low or high ADI did not correlate with seasonal changes in the use of telemedicine, encounter type, or patient demographics. Telemedicine may improve patient access to hand surgery follow-up care. This may particularly benefit patients facing geographic and economic challenges to healthcare access. Prognostic Level IV.

An evaluation of a virtual musculoskeletal podiatry service implemented to address prolonged National Health Service waiting times.

The COVID-19 pandemic had a substantial impact on healthcare systems globally, particularly in the public sector. To address the challenges posed by the pandemic, musculoskeletal (MSK) healthcare providers had to rapidly adopt virtual platforms for delivering care, representing a major shift in how healthcare was delivered. This manuscript aims to retrospectively evaluate a virtual MSK podiatry service offered by a private provider under a National Health Service commission, in terms of patient access, waiting times and patient-reported pain. This service was developed and implemented in response to the COVID-19 pandemic and the extended waiting times. A retrospective clinical service evaluation was conducted on MSK podiatry services delivered via telephone or virtual consultations. The evaluation covered a cohort of 574 referred patients over a 19-month period (July 2021 to January 2023). It analysed demographic data, initial and final visual analogue pain scores, pathology categories, orthoses prescriptions and exercise rehabilitation plans. Data from a total of 492 patients (male=152 and female=340) were analysed, with 82 patients excluded for non-attendance. The average waiting time from referral-to-first appointment and referral-to-discharge was 35 and 91days, respectively. Results showed statistically significant improvement (p<0.001) in the mean visual analogue scale when patients received orthoses with and without a rehabilitation plan (4.12±2.55 and 3.33±2.88, respectively). Most patients (61.5%) were aged 40-69, with "foot pain" being the main reported pathology category. Patients had an average of two appointments. 56.5% of patients remained virtual throughout their journey and were successfully discharged to self-management. 43.9% were discharged to other face-to face services. The study provided evidence that the virtual MSK podiatry service achieved a statistically significant reduction in patient-reported pain for various pathologies with reasonable waiting times. The service delivered favourable outcomes and complemented traditional services at a time with limited access due to the COVID-19 pandemic.