Fibromyalgia, a musculoskeletal ailment of unknown origin, profoundly affects quality of life. Emerging bioelectrical stimulation techniques, including transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and pulsed low-frequency magnetic field stimulation (PEMF), show promise in short-term pain alleviation. This study aimed to rigorously evaluate the effectiveness and safety of these techniques in treating fibromyalgia.

A systematic review (SR) of available literature on the effectiveness and safety of bioelectrical stimulation techniques was carried out according to the Cochrane Collaboration methodology and PRISMA reporting guideline. Evaluated studies included SRs (with or without meta-analyses) and randomized controlled trials (RCTs) published after the SRs. SRs were appraised with the AMSTAR-2 tool and RCTs were assessed with version two of the Cochrane Collaboration risk-of-bias tool for randomized trials. The findings were synthesized narratively. In the absence of SRs with meta-analyses for specific techniques, we conducted a meta-analysis for each available outcome measure, including pain, fatigue, symptom severity, quality of life, anxiety, and depression.

Seven SRs incorporating 35 RCTs were included. Two SRs evaluated TMS effectiveness, while five focused on tDCS. Additionally, 17 RCTs were included: two on repetitive TMS, six on tDCS, and eight on PEMF (three assessing targeted PEMF). General confidence in the SR results varied, with most having critically low confidence. Three additional RCTs were rated as low risk of bias, seven were rated as unclear risk of bias, and the remaining seven were rated as high risk of bias. A meta-analysis covered additional RCTs on PEMF and assessed pain intensity, symptom severity, general health-related quality of life, and fibromyalgia-related quality of life.

Overall, the results suggest that repetitive TMS, tDCS, and PEMF could improve pain and quality of life in patients with fibromyalgia. It is, however, necessary to conduct high quality studies to demonstrate the clinical relevance of these effects. While the techniques evaluated appear to be safe, mild adverse effects involving the area of stimulation may occur.

In Italy, the first-line treatment for gastroesophageal reflux disease (GERD) is proton pump inhibitors (PPIs). Other options considered after PPI failure include Nissen fundoplication and magnetic sphincter augmentation. RefluxStop is a novel device for treating GERD. The aim of this study was to evaluate the budget impact of introducing RefluxStop into the Italian National Health Service (SSN).

The analysis, which used a five-year time horizon, one-year cycle length, and Italian payer perspective, was developed in line with ISPOR recommendations. Estimates for the Italian population and growth projections, GERD prevalence and incidence rates, and rates of anti-reflux surgery were obtained from relevant literature sources. The current market share of those requiring surgery was based on market research by Implantica (Zug, Switzerland). The cost of treatment was based on an adaptation of an economic model from the UK applied to the Italian setting. Unit costs were derived from available literature and diagnosis-related groups averaged across five Italian regions. Extensive sensitivity analyses involving key model inputs were also conducted.

The overall one-year, three-year, and five-year financial impacts of introducing RefluxStop were EUR 242,641, EUR 710,651, and EUR 1,004,946 per year, respectively, corresponding to 0.063 percent, 0.197 percent, and 0.316 percent annual increases in overall Italian SSN expenditure for GERD. Use of more optimistic and pessimistic market uptake and surgery rates (i.e., doubled and halved) for RefluxStop led to one-year increases in Italian SSN expenditure of 0.126 percent and 0.032 percent and five-year increases of 0.636 percent and 0.155 percent, respectively. In our study, introducing RefluxStop avoided 95 surgical failures, 11 reoperations, and 64 endoscopic esophageal dilatations over five years.

The introduction of RefluxStop is likely to provide substantial benefits for patients with GERD at the cost of a marginal budget impact on the Italian healthcare system. Though Italian health care is organized at a regional level, this study is an example of a health technology assessment using budget impact analysis at a national level.

Ultrasonic scalpels are widely used in urological surgery. Although portable ultrasonic scalpels are convenient to use and install, the existing evidence on their safety and effectiveness is scarce. This study aimed to compare the safety and effectiveness of portable ultrasonic scalpels in urological surgery with traditional ultrasonic scalpels to aid clinical decision-making.

A multicenter, prospective, non-randomized controlled trial was conducted from February to August 2023 in three tertiary hospitals in China. The intervention group included 90 prospectively enrolled patients undergoing urological surgery during the same period of hospitalization: 45 with portable ultrasonic scalpels and 45 with traditional scalpels. Demographic and clinical data of patients in the study were collected. Data on quality of life were obtained using the EuroQol EQ-5D-5L scale preoperatively, at discharge, and one month and three months after surgery. Descriptive analysis and a generalized linear model were used in the data analysis.

A total of 82 patients were included in the study: 39 in the intervention group and 43 in the control group. The average hospital stay and intraoperative and postoperative blood loss in the intervention group were lower than in the control group (p>0.05). From baseline to discharge, the decrease in quality-adjusted life-years (QALYs) in the intervention group was smaller (–0.134 versus –0.287; p<0.05) than in the control group. During the follow-up period, there were no significant differences in the changes in QALYs between the two groups. The decline in QALYs was significantly influenced by variables such as intraoperative blood loss and surgical site.

There were no significant differences in baseline characteristics or changes in QALYs between the intervention and control groups. Portable ultrasonic scalpels in urological surgery may be as equally effective as traditional scalpels with respect to clinical outcomes, with additional benefits in reducing QALY decline at discharge. Further research with large samples and long-term follow-up should be conducted.

Spinal cord atrophy (SMA) affects one in every 1,000 live births in Spain. Cerebral palsy (CP) is the most common cause of chronic motor disability in children, affecting two to three in every 1,000 live births. The Atlas 2030 exoskeleton is the first portable robotic pediatric exoskeleton aimed at facilitating walking in these children. It is used as a complement to other therapies.

We aimed to compare the efficacy and safety of the ATLAS 2030 exoskeleton with conventional physiotherapy in children aged between four and 12 years with SMA or CP. We conducted a literature search to identify clinical trials and systematic reviews in the PubMed, Embase, Web of Science, and Cochrane Library databases, finding 201 original articles published between 2017 and 2022. No controlled studies were found on the ATLAS 2030 or any other portable device, even after expanding the searches to any robot-assisted gait devices.

Although systematic reviews evaluating the efficacy and safety of robotic orthoses in general were found, there were no specific controlled studies on the ATLAS 2030. The five studies found (two on CP and three on SMA) were of low quality and did not show conclusive results in terms of efficacy and safety. However, some of them suggested that this technology could provide significant improvements in acceptability, range of motion, and spasticity. With respect to safety there appeared to be no evidence of serious adverse effects from its use, reinforcing the developer’s initial hypothesis that the technology is safe.

Although the available evidence is very limited, the ATLAS 2030 appears to show efficacy in some gait-related outcomes without serious adverse effects. To demonstrate safety and efficacy, randomized controlled trials are required that compare the ATLAS 2030 with conventional physiotherapy, with more participants and a longer duration, and are conducted by independent expert groups without conflicts of interest.

Percutaneous ethanol injection (PEI) is a valuable treatment for several health conditions. However, its beneficial and harmful effects in patients with thyroid nodular pathology and metastatic cervical adenopathies have not been assessed in a systematic review.

A systematic review of available scientific literature on the safety, effectiveness, and cost effectiveness of PEI in thyroid nodular pathology and metastatic cervical adenopathies was performed according to Cochrane Collaboration methods and reported in accordance with the PRISMA statement. A cost-minimization analysis was carried out using a decision tree model. Assuming equal effectiveness between two minimally invasive techniques (PEI and radiofrequency ablation [RFA]), the model compared the costs of the alternatives with a horizon of six months from the perspective of the Spanish National Health System.

Three randomized controlled trials (n=157) evaluating PEI and RFA in patients diagnosed with benign thyroid nodules, 96 with predominantly cystic nodules and 61 with solid nodules, were identified. No evidence was found on other techniques or thyroid nodular pathology. No statistically significant differences were observed between PEI and RFA in proportion of volume reduction, symptom score, cosmetic score, therapeutic success, or major complications. No economic evaluations were identified. The cost-minimization analysis estimated the cost per patient of the PEI procedure to be EUR326, compared with EUR4,781 for RFA, with an incremental difference of −EUR4,455.

There are no differences between PEI and RFA in terms of safety and effectiveness, but the economic evaluation determined that the former option is cheaper.

The COVID-19 pandemic has catalyzed a move from face-to-face to online delivery of services by hospitals and primary care providers, but little is known about the impact of digital transformation in organizations supporting unpaid caregivers. The value of care provided by informal caregivers since the start of the COVID-19 pandemic has been estimated at EUR111 billion in England.

The study assessed the impact of digital transformation in an English caregivers’ support organization covering a population of 0.98 million. A retrospective mixed method study was conducted of digital and non-digital support service utilization among caregivers in city and rural geographical areas from January 2019 to June 2021. Organizational performance and service quality indicators were compared for two financial years: 2019-2020 and 2020-2021. A survey of users was conducted to evaluate barriers to and facilitators of digital service uptake, computer proficiency among caregivers, and preferences for future digital service provision.

The number of caregivers registered with the organization rose by 36 percent to 20,237 in 2021. Monthly contacts rose by 225 percent to 6,500, with remote contacts rising from 65 to 85 percent. Observed behavior patterns differed between city and rural caregivers. Overall, one-to-one contacts increased by 89 percent and caregiver assessments by 21 percent, with no expansion in staffing. User-reported service quality improved in five out of eight indicators (p<0.05). The demographic characteristics of survey respondents (152 caregivers) were similar to all registered caregivers. The mean short form Computer Proficiency Questionnaire score of 25.61 indicated a relatively high computer proficiency. Qualitative analysis confirmed a preference for face-to-face and online options. The most highly rated online services were peer support groups and wellbeing assessment and support needs checks.

Considering the economic importance of unpaid caregivers, more attention should be paid to the organizations supporting them and the potential for technology to enhance caregivers’ access to and benefit from such services. This initial assessment of digital transformation in one such organization demonstrates the potential for cost-effective service transition. Further research is required to inform sustainable future solutions.

This study identified health susceptibility using socioeconomic and environmental indicators, focusing on their impact on population health, by using a health vulnerability index (HVI). The aim was to map vulnerabilities using the HVI among beneficiaries of a health maintenance organization (HMO) in the metropolitan region of Belo Horizonte (MRBH), to enhance access, efficiency, equity, and quality in health services.

Established in 2012 by Belo Horizonte’s municipality using 2010 census data, the HVI incorporates eight socioeconomic and sanitation indicators. This methodology was extended to all HMO beneficiaries in the MRBH using georeferencing to assess their vulnerability levels (low, medium, high, or very high) and proximity to health facilities.

The findings revealed that 5.44 percent of the HMO’s clients reside in areas categorized as high or very high risk, which corresponds to more than 70,000 individuals. Notably, 91.8 percent of these high-risk beneficiaries are situated in the suburban and peripheral areas of the region and predominantly utilize health facilities located on the outskirts of Belo Horizonte or within the metropolitan area. This distribution underscores a notable disparity in healthcare accessibility and service utilization patterns, with a marked inclination toward the use of emergency services among these populations.

The study underscores a strong correlation between vulnerability and the type of healthcare service utilized, with vulnerable groups often resorting to emergency services, which leads to fragmented care. It highlights the need to improve service processes, particularly for those reliant on public transport, and advocates for an integrated approach to health interventions that promotes equitable healthcare access in complex socioeconomic landscapes.

Ward round quality is a pivotal component of surgical care and is intimately associated with patient outcomes. Despite this, ward rounds remain largely understudied and underrepresented in medical literature. Accurate and thorough ward round documentation is known to improve communication and patient outcomes and to reduce hospital expenditure. This study aimed to determine the accuracy of ward round documentation.

A prospective observational cohort study was performed as a sub-analysis of a larger study by reviewing 135 audiovisual recordings of surgical ward rounds over two years at two hospitals. The recordings were transcribed verbatim, and content was designated a level of importance by an external reviewer. This was then compared to the written case notes to determine the accuracy and importance of omitted documentation. Patient age, sex, and length of stay, as well as the senior doctor leading and the intern documenting the ward round, were assessed using multivariable linear mixed-effect models to determine their impact on documentation accuracy.

Nearly one-third (32.4%) of spoken information on the surgical ward round that was deemed “important”, including discharge plans and bookings for surgery, was absent from the patients’ electronic medical records. Additionally, in 11 percent of case notes there was a major conflict between the ward round discussion and what was documented. Younger patients (p=0.04) and patients who had been on the ward longer (p=0.005) were less likely to have accurate documentation. Some interns were significantly worse at documenting discussions than were others (p<0.0001). Day of the week, location, and the senior doctor present did not affect documentation accuracy.

This study demonstrates that a significant amount of important discussion during surgical ward rounds regarding patient care is not recorded accurately, or at all, in the patient medical record. This can lead to preventable patient complications and longer hospital stays, resulting in increased strain on hospital resources. This study emphasizes the need for further research to address this problem.

Following a health technology assessment, the Health Service Executive (HSE) supported reimbursement of dupilumab subject to a managed access protocol (MAP) being implemented. Reimbursement is restricted to a subgroup of the fully licensed indication, that is, moderate-to-severe refractory atopic dermatitis (AD) in adults and adolescents 12 years and older. This study provides an overview of the first year of the MAP.

All reimbursement applications submitted to the HSE Medicines Management Programme between 1 April 2021 and 31 March 2022 were reviewed. Key demographic and clinical characteristics of the approved population were analyzed. Reimbursement claims data within the specified period were extracted from the HSE Primary Care Reimbursement Services national pharmacy claims database. All data were compiled and analyzed using SPSS Statistics 27. Expenditure estimates were based on wholesale prices and were exclusive of value-added tax, fees, and confidential rebates.

During the study period, 382 applications were submitted, 96 percent (n=365) of which were approved. Among approved patients, the mean age was 35 years (range 12 to 79 years), the mean number of years between AD diagnosis and approval was 22.65 years (range 1 to 78 years), and 65 percent (n=238) were men. The mean Eczema Area and Severity Index score was 28.72 and the mean (Children’s) Dermatology Life Quality Index score was 19.72. Approved patients who had unsuccessfully tried other systemic immunosuppressants had trialed up to five different medicines (mean=1.6). Year one expenditure was EUR2.4million, with 70 percent of approved patients accessing treatment.

Most applications submitted through the MAP were approved. These patients met the predefined evidence-based eligibility criteria for treatment. Patient numbers were higher than estimated, suggesting that the MAP did not hinder access. Utilizing health technology management by way of a MAP has facilitated access to expensive medicines for patients with the greatest need, while controlling expenditure for the payer.

The calcitonin gene-related peptide monoclonal antibodies (CGRP MABs) erenumab, fremanezumab, and galcanezumab are reimbursed in Ireland under the High Tech Arrangement, subject to a managed access protocol (MAP), for the prophylaxis of chronic migraine in adults in whom three or more prophylactic treatments have failed. This study provides an overview of submitted reimbursement applications and the utilization of CGRP MABs.

The MAP for CGRP MABs was introduced on 1 September 2021 and is operated by the Health Service Executive (HSE) Medicines Management Programme. Individual patient reimbursement applications for CGRP MABs submitted through an online reimbursement application system between 1 September 2021 and 30 April 2023 were reviewed. Utilization data from 1 September 2021 to 30 April 2023 were extracted from the HSE Primary Care Reimbursement Service national pharmacy reimbursement claims database for the High Tech Arrangement. Analysis was performed using SAS® 9.4 software.

A total of 1,517 reimbursement applications were submitted in the study period. Reimbursement was approved for 96.1 percent (n=1,458) of the applications. A total of 1,399 individual patients (mean age 45 years) were dispensed a CGRP MAB under the High Tech Arrangement between September 2021 and April 2023, the majority of whom were women (n=1,141). Almost 90 percent of patients were considered treatment adherent. In April 2023, the market share of the individual CGRP MABs on the High Tech Arrangement was 56 percent (n=599) for fremanezumab, 38.3 percent (n=409) for erenumab, and 5.7 percent (n=61) for galcanezumab.

MAPs are part of the health technology management approach to drug reimbursement in the Irish healthcare setting, ensuring that reimbursement is in line with approved subgroups of the licensed indication. Used in conjunction with health technology assessment, MAPs enable access to high-cost drug treatments for patients with the greatest unmet need, while providing budgetary oversight and certainty for the payer.

Approximately five million people live with diabetes in the UK. The cost of this is approximately 10 percent of the National Health Service (NHS) budget. Wales has the highest prevalence of diabetes of any country in the UK. Educating people on how to best manage their condition can minimize associated complications. Digital platforms can aid self-management and improve risk factors.

This rapid review aimed to address the following research question: What is the clinical and cost effectiveness of digital platforms for personalized diabetes management to inform decision-making and guidance in the NHS? Digital platforms for this rapid review can be driven using artificial intelligence, machine learning, or through the application of data rules. Clinical evidence published since 2008 on health economics and patient, carer, and family perspectives relevant to Wales was identified by searching relevant databases such as MEDLINE. One relevant economic analysis was conducted using the UK Prospective Diabetes Study Outcomes Model 2.

Outcomes included improvements in glycemic control, healthcare resource use (e.g., number of total general practitioner and emergency department visits per year), reduction in body weight among participants, reduction in cholesterol levels, and positive patient-reported outcome measures. An economic analysis identified in the literature review found that a digital platform was more effective and less costly than routine diabetes care and was, therefore, dominant. The analysis was based on observed reductions in glycosylated hemoglobin levels from a database of people with diabetes in NHS Scotland.

The evidence suggests there are benefits in using digital platforms to aid self-management among people with diabetes. Studies reporting on glycosylated hemoglobin levels found statistically significant and clinically important benefits from using digital platforms. Digital platforms also have the potential to be more effective and less costly than routine diabetes care in Wales and the UK.

Effectiveness, efficiency, and consistency with patient preferences are requirements for appropriate healthcare. The Complex Treatment Evaluation Committee (CTEC) at the Arturo López Pérez Foundation is a multidisciplinary committee that assesses the appropriateness of high-cost cancer drug prescriptions (HCCDP) and authorizes their use accordingly. Our study aimed to develop a value framework to assess the appropriateness of HCCDP at the Foundation.

We conducted a literature review to identify appropriateness criteria for oncology prescriptions and the judgments used by the Chilean healthcare system for clinical practice guideline recommendations and reimbursement decisions for these medications. The results were discussed by the CTEC to establish a final value framework through consensus and to define a methodology to assess the appropriateness of HCCDP weekly. Annual indicators were designed to improve the agreed methods and the adequacy of prescriptions.

Criteria for the value framework were grouped into three categories: magnitude of clinical benefit, efficiency, and sustainability. Every criterion should be met to consider an HCCDP as appropriate. Adequacy was evaluated by assessing prescription evidence identified from electronic databases, evidence-based clinical practice guidelines, regulatory agency reports, and health technology assessment reports. From 2019 to 2022, 1,626 cases have been evaluated. Although potentially inappropriate CTEC authorizations have decreased over time, there was a growing mismatch between these decisions and the prescribing behavior of clinicians.

By involving clinicians, managers, and health economists we developed a value framework for the timely assessment of the appropriateness of HCCDP in a hospital setting. Further research on the underlying reasons for the differences observed is needed, along with additional appropriateness criteria such as consistency with the preferences and ethical principles of patients.

To reduce the burden of medical expenses on patients, some noncovered medical technologies with proven safety but uncertain therapeutic effectiveness or cost effectiveness are incorporated into the “selective benefit (SB) system” and reassessed regularly to determine reimbursement scope. This study proposes a matrix based on the usage trends of new technologies (NTs) and alternative therapies (ATs) to facilitate efficient reassessment.

This study investigated the following five indices: (i) replacement of an NT by an AT; (ii) market shares of NTs; (iii) usage trends of NTs; (iv) usage trends of ATs before and after introduction of NTs; and (v) social demand for NTs. These were combined to generate an algorithm-based matrix that classified 139 NTs into 22 cases and five reimbursement scope categories. Health insurance data from 2009 to 2021 were analyzed to investigate market shares and usage trends. Social demand was evaluated using the last assessment results for each NT.

Using the matrix, 139 NTs were classified as follows: (i) switch to an essential benefit (copayment 20%; n=11); (ii) stay as a SB (copayment 50%; n=19); (iii) stay as a SB (copayment 80%; n=30); (iv) stay as a SB (copayment 90%; n=8); and (v) convert to noncovered (copayment 100%; n=40). The remaining 31 with an insufficient analysis period were classified as a SB (copayment 80%) for further analysis. Excluding the latter 31 SBs, 57 of the 108 (53%) were classified as “stay as a SB” categories, suggesting that these technologies need to be monitored further.

The usage trend driven matrix may be useful for efficient reassessment of NTs. For example, NTs that have a high market share and an increasing usage trend and ATs with a decreasing usage trend after SB of an NT can potentially be switched to an essential benefit.

The Agency for Care Effectiveness (ACE) conducts health technology assessments (HTAs) to inform funding decisions by the Ministry of Health (MOH) Drug Advisory Committee (DAC) in Singapore. In 2021 ACE introduced the company-led submission (CLS) process for cancer medicines, which allows pharmaceutical companies to request evaluations alongside regulatory reviews. This review reports key findings from the first year of its implementation.

A total of 10 CLS topics from the first year of implementation were included. We reviewed the status and outcomes of the DAC recommendations. We also used descriptive statistical methods to evaluate the time from HTA submission to first HTA recommendation and from regulatory approval to first HTA recommendation. The timelines were further analyzed by whether submissions were parallel submissions (i.e., HTA submission in tandem with regulatory review) or sequential submissions (i.e., HTA submission after regulatory approval). These statistics were compared with overseas reference jurisdictions (Australia, Canada, and the UK).

At the time of review, three topics were pending discussion. Of the remaining seven topics, three (43%) received positive recommendations for inclusion on the MOH Cancer Drug List and three (43%) received negative recommendations. The DAC was unable to make a recommendation on one topic. The median time from HTA submission or regulatory approval to first HTA recommendation was 172 days (range 169 to 263 days) and 279 days (range 53 to 374 days), respectively. Notably, parallel submissions (75 days; n=2) had considerably shorter timelines from regulatory approval to first HTA recommendation than sequential submissions (328 days; n=4). These timelines were within the range of the overseas reference countries.

Parallel CLS allows HTA processes to be conducted in tandem with regulatory reviews, moving HTA recommendations upstream and expediting patient access to clinically effective and cost-effective medicines. Efforts will be made to further evolve the CLS process to achieve timely reimbursement reviews from regulatory approval and to expand this process to noncancer medicines.

Long COVID, which encompasses a range of prolonged and persistent symptoms that occur after the acute SARS-CoV-2 infection period, can have substantial negative physical, mental, social, and economic effects. This systematic review aimed to assess the effectiveness and safety of interventions to improve long COVID symptoms to inform updates to the interim long COVID model of care in Ireland.

Studies were identified in the MEDLINE, Embase, and CENTRAL databases through February 2023. Inclusion criteria were: (i) participants with long COVID, as defined by the study authors; (ii) random assignment to either an intervention or a comparison group; and (iii) quantitative assessment of the severity or frequency of long COVID symptoms. Exclusion criteria were: (i) signs or symptoms not reasonably attributable to prior SARS-CoV-2 infection; (ii) interventions not intended to treat long COVID; and (iii) not a randomized controlled trial. Two reviewers independently screened studies, extracted data, and assessed study quality using the Cochrane risk-of-bias tool for randomized trials. The results were synthesized narratively.

Fifty-seven studies were included, and 283 potentially relevant ongoing trials were identified. Twenty-four trials investigated pharmaceutical and other medical interventions, most of which were examined in single studies. Thirty-three trials investigated non-pharmaceutical interventions. Risk of bias was high in 41 of the 57 (72%) studies. Interventions targeted a diverse range of long COVID symptoms. Studies generally had small sample sizes and short follow-up periods and did not adequately examine intervention safety. Evidence for the effectiveness of pharmaceutical and other medical interventions was limited. Potential short-term improvements were seen for some people following personalized exercise and physiotherapy and rehabilitation programs. However, long-term outcomes were not assessed.

Effective interventions to improve the symptoms of long COVID remain elusive and those included in this review do not yet have sufficient evidence to support them. In the absence of strong evidence for specific interventions, a holistic approach should be used to support people with long COVID.

Despite medical advancements, endocarditis still results in high mortality rates. Surgery, while often essential, elevates the risk of hyperinflammation, sepsis, and cytokine release. The use of a cytokine filter to prevent this remains controversial. This study reviewed existing literature to assess the efficacy of cytokine filters and to support its integration into supplementary health services.

An exhaustive search of the MEDLINE, Cochrane Library, Embase, LILACS, and CytoSorbents Corporation databases was conducted to identify relevant meta-analyses and systematic reviews. The study focused on randomized controlled trials and case series studies assessing the efficacy of cytokine filtration. Key variables considered were the duration of antibiotic treatment, severity of endocarditis, and surgical treatment rationale. These factors were crucial for evaluating clinical outcomes and patient survival after surgery.

The systematic reviews yielded mixed outcomes. Two found no benefits for hemoadsorption, while one found that it reduced mortality rates and intensive care unit stays based on observational studies. Randomized controlled trials, however, showed no significant impact for cytokine filters on mortality rates or postoperative hemodynamic parameters. In contrast, case series studies reported potential benefits, but these results were confounded by biases in patient allocation and failure to account for critical variables like antibiotic treatment duration, case severity, and surgical rationale. These discrepancies highlight the complexity of evaluating the effectiveness of cytokine filtration in surgical settings.

Randomized and non-randomized controlled trials on the role of cytokine filters in cardiac surgery for endocarditis reported contradictory findings. Only case series studies suggested benefits from cytokine filters, necessitating further high quality research before recommending their widespread use. Understanding the implications of these results is essential, underscoring the need for more rigorous studies to resolve these inconsistencies.

The genicular artery embolization (GAE) procedure has been recently adopted for the management of pain secondary to inflammatory diseases of the locomotor apparatus. The number of studies assessing its use in patients with knee osteoarthritis (KO) has been increasing in recent years.

We included two randomized controlled trials (RCTs) evaluating the use of GAE in patients with chronic pain secondary to KO. A cost analysis was also conducted to compare the costs of GAE and standard treatment from the perspective of the Spanish National Health System over a time horizon of one year. The potential improvement in quality-adjusted life-years necessary to consider GEA as cost effective for this indication was estimated. We also ran extensive sensitivity analyses.

Estimates for pain showed contradictory results, and no significant differences were observed between the two treatments with respect to overall function, health-related quality of life (HRQoL), and need for pain medication. No serious complications or major adverse events were observed. The quality of evidence was assessed by GRADE as moderate to low. The cost analysis showed that GAE results in an incremental cost of EUR3,432.37 per patient. Sensitivity analyses revealed a wide range within which the incremental cost can vary.

There are insufficient data to discern any differences between GAE and standard treatment for patients with KO in terms of pain, function, HRQoL, need for analgesics, and rates of adverse events and complications. Larger RCTs are required to evaluate the effect of GAE in patients with chronic pain secondary to KO and to determine whether its additional cost is warranted.

Robotic surgery (RS) is a minimally invasive surgical modality performed with the support of a console and mechanical arms that enable remote control. The advantages of RS are clear from the point of view of surgeons but remain unclear in terms of clinical results. We evaluated the safety, efficacy, and clinical effectiveness of RS compared with open or laparoscopic surgery.

A systematic review of randomized controlled trials and systematic reviews with meta-analyses was conducted to assess RS in the following surgical procedures: Nissen fundoplication, Heller myotomy, cholecystectomy, rectopexy, splenectomy, pediatric Kasai portoenterostomy, and gastric banding. Outcomes of interest were related to safety (complications, blood loss, and risk of infection) and efficacy or effectiveness (length of hospital stay, quality of life [QoL], recovery, patient satisfaction, conversion to another technique, urinary function, and rates of mortality, readmission, reoperation, and esophageal perforation). The evidence quality was assessed with version two of the Cochrane risk-of-bias tool for randomized trials, AMSTAR 2, and GRADE.

Nissen fundoplication RS was similar to laparoscopy in terms of complication and conversion rates, recovery, and QoL. Heller myotomy RS reduced the rate of esophageal perforations but had similar perioperative blood loss and rates of mortality, conversion, and re-admission to laparoscopy. Cholecystectomy RS was similar to laparoscopy with respect to rates of readmission and complications, blood loss, and risk of infection. Rectopexy RS was similar to laparoscopy in terms of conversion, reoperation, and complications rates, blood loss, recovery, patient satisfaction, and QoL. Splenectomy RS decreased blood loss but was similar in risk of infection and rates of complications and conversion to laparoscopy. There were no studies that used open surgery as a comparator or evaluated RS in pediatric Kasai portoenterostomy or gastric banding.

Current evidence on the safety, efficacy, and clinical effectiveness of RS in general or digestive surgical procedures is limited. Multicenter studies with follow-up beyond the immediate postoperative period are needed to evaluate patient outcomes.

Colonoscopy screening has been suggested as a potential primary screening method for colorectal cancer (CRC). A 10-year screening interval has been recommended by some academic societies, but the scientific evidence for this needs to be more comprehensive. We performed a systematic review of interval cancer rates in colonoscopy screening in an asymptomatic population.

We searched the PubMed and Ichushi-Web bibliographic databases for papers published from inception to September 2022. The search terms were “colorectal cancer screening”, “interval cancer”, and “total colonoscopy”. Randomized controlled trials and observational studies were included. The target population was an asymptomatic average-risk population with no polyps or adenomas at the index colonoscopy. Advanced neoplasia (AN) was defined as CRC or an adenoma at least 10 mm in size with a villous component or high-grade dysplasia. The incidence rates of interval CRC and AN per 100,000 person-years (PYs) were estimated.

Of the 694 potentially eligible articles, 15 were included. Rates of interval CRC and AN were reported in 15 and 11 studies, respectively. For the meta-analysis, 287,602 patients with negative colonoscopy results were included, with an average follow-up of 7.98 years. Negative colonoscopy results were defined as no adenoma present. The incidence rate per 100,000 PYs was 9.57 (95% confidence interval [CI]: 2.06, 29.94) for interval CRC and 311.5 (95%CI: 153.4, 550.7) for AN. Similar results were obtained even when a negative colonoscopy result was defined as no polyps present.

The selected studies were heterogeneous with respect to the target population, follow-up years, and patient characteristics. Although interval AN was reported in all studies, the interval cancer rate was low after a negative result at the index colonoscopy. While the screening interval might be defined as long term, a definitive screening interval could not be recommended because of insufficient evidence.

The herpes zoster (HZ) virus is associated with significant morbidity. Its incidence and severity are higher among older adults and immunocompromised individuals. This systematic review assessed the clinical efficacy and effectiveness of recombinant zoster vaccine (RZV) for the prevention of HZ and associated complications in adults at least 50 years of age and in adults (≥18 years) at increased risk of HZ.

Electronic searches restricted to between 2008 and July 2023 were conducted in Embase, MEDLINE, the Cochrane Library, and clinical trial registries. Two reviewers independently screened articles and extracted data. The review adhered to the PRISMA reporting guidelines. Quality appraisal was assessed using version two of the Cochrane risk-of-bias tool for randomized trials tool and the Risk of Bias in Non-Randomized Studies - of Interventions tool. Meta-analysis was undertaken using Cochrane methodology, with preference given to random effects meta-analysis because of study heterogeneity.

Twelve RCTs and five cohort studies were identified. Vaccine efficacy was defined as one minus the incidence rate ratio, multiplied by 100. For the general population, vaccine efficacy was 92 percent (n=29,311 individuals) and vaccine effectiveness was 70 percent (n=43,990,671 individuals). Based on one trial, vaccine efficacy in the general population (aged ≥50 years) waned from an initial 97.7 percent to 73.2 percent by year 10. Two RCTs reported vaccine efficacy for those at increased risk: 68.2 percent in hematopoietic stem cell transplant recipients and 87.2 percent in those with hematological malignancies. Secondary analyses were limited by sample size.

There is clear, consistent evidence that RZV is effective in reducing HZ incidence. Although the vaccine is effective in those who are least 18 years of age and are at increased risk of HZ, efficacy may be lower compared with a general population aged at least 50 years. Secondary analyses (age subgroups, HZ complications, and HZ-related hospitalizations) were limited by small sample size, leading to inconclusive results.