International Journal of Technology Assessment in Health Care最新文献

Clinically significant cytomegalovirus infection (CSI-CMV) is an important factor associated with mortality in patients undergoing hematopoietic stem cell transplantation (HSCT). It is estimated that the incidence of CSI-CMV in the post-HSCT period is 30 percent to 70 percent in transplanted individuals. Therefore, CSI-CMV is considered a complication in allogeneic HSCT, which can trigger Cytomegalovirus disease (CMVD). Letermovir is an antiviral agent indicated especially for the prophylaxis of CMVD post-HSCT. The objective of this work was to evaluate the efficacy, effectiveness and safety of letermovir, comparing it with placebo or other existing prophylactic treatments.

A systematic review was carried out according to PRISMA 2020. A strategy was developed for searching electronic bibliographic databases. Retrieved publications were selected by a pair of reviewers. The same pair performed the data extraction. A qualitative assessment of the efficacy, effectiveness and safety of letermovir was performed.

Eighteen studies were included, being experimental and observational. Overall, the pivotal RCT demonstrates the efficacy of letermovir in reducing the incidence of CSI-CMV. However, there was no statistically significant difference in all-cause mortality and letermovir-related overall survival, events of graft versus host disease, neutropenia, acute kidney disease and 48-week mortality. Observational studies, in general, present results similar to those found in the pivotal RCT. The main adverse events associated with letermovir were peripheral edema (14.5%), vomiting (18.5%), headache (13.9%), cough (14.2%), abdominal pain (11.8%) and fatigue (13.4%).

The prophylactic use of letermovir in CMV-R+ patients after allogeneic HSCT demonstrates beneficial results in the prevention of CSI-CMV. However, there were no identified improvements for other outcomes. As for safety, it was observed that there is still little information about adverse events related to the drug, and studies assessing this aspect are needed for better comprehension.

During the COVID-19 pandemic, the use of e-services increased, bringing a better choice of technologies and services. Nevertheless, these services require the use of sensitive personal data, which increased the level of risk because of potential privacy and security breaches. As a result, citizens are more concerned about their privacy, security, and personal data protection. The SOTERIA project aims to provide a secure and user-driven solution. This study aims to identify barriers and key points related to citizens when using digital systems for data interoperability.

Both qualitative and quantitative approaches were applied in order to identify and measure citizens’ general needs regarding the tool to be developed within the context of SOTERIA. The questionnaire was distributed throughout the three European countries under study: Austria, Romania, and Spain, with 400 responses collected in each country. The distribution of sex, age, occupation and educational level was representative in the entire sample.

This study corroborates the critical role of perceived security in the intention to adopt new technologies. In addition, to trust and being consistent with the extant literature on technology adoption/acceptance, perceived benefits and usefulness also play a crucial role in driving attitudes and behavioral intention to adopt digital data wallet (DDW). Our findings show that perceived ease of use, the user’s belief of having no difficulty using the technology (i.e., DDW), is a significant predictor of consumers’ intentions to use DDW. Our qualitative data from both the in-depth interviews and focus groups also revealed convenience, being comfortable, and/or less time and energy needed to use DDW in comparison to one’s current situation, to be a determinant of perceived benefits. Transparency, which provides consumers with knowledge of how firms manage their personal information, was also viewed as important among our participants in both in-depth interviews and focus groups. Our findings corroborate previous studies that report the control of privacy concerns, or the extent to which consumers believe they can manage the flow of information, feel comfortable and enhance their perceived view of privacy or lower privacy concerns.

Our qualitative studies confirmed that trust, or consumers’ expectation of how data will be handled in the future plays an important role in influencing the intention of DDW adoption.

Hereditary Transthyretin amyloidosis (hATTR) is a rare autosomal dominant, multisystemic, progressive, and potentially fatal genetic disease. Currently, the only drug made available in the Brazilian National Health System to treat hATTR is tafamidis meglumine, indicated for symptomatic adult patients in early stage (stage 1) and not undergoing liver transplantation for amyloidosis associated with hATTR.

A systematic review was conducted in the databases MEDLINE via Pubmed, Embase, The Cochrane Library, and LILACS addressing the question “Is patisiran treatment effective and safe for patients diagnosed with ATTRh amyloidosis with stage 2 polyneuropathy or who have an inadequate response to tafamidis?”

The 13 studies included in the review demonstrate the efficacy of patisiran in reducing the neuropathic progression of the disease, as evidenced by decreased mNIS+7 scale scores following 18-month use of the drug. Improvements in the quality of life of patients taking patisiran have been reported, as measured by reduced scores on the Norfolk-QoL-DN scale. Patisiran has also been shown to be effective in reducing NT-proBNP, a marker related to cardiac stress. Improvements in the nutritional status of patients taking patisiran were demonstrated by increasing modified body mass index (BMI). Good tolerability of patisiran was observed by patients using it. Most adverse events were classified as mild or moderate. The studies indicated that the occurrence of deaths is similar between the patisiran and placebo groups. Most deaths were related to cardiac events and were not associated with the use of patisiran.

The use of patisiran in patients with hATTR demonstrated efficacy in reducing the neuropathic progression of the disease, evidenced by decreased mNIS+7 scale scores, improvements in quality of life as measured by reduced Norfolk-QoL-D scale scores, and reduced NT-proBNP. The drug patisiran was well tolerated, with most adverse events rated as mild and moderate.

Robot-assisted surgery is one of the minimally invasive surgical approaches that has been increasingly utilized across a wide range of surgeries. However, there is limited evidence of robotic-assisted thoracic surgery (RATS) for patients with lung cancer. This study aims to evaluate the safety and effectiveness of RATS in lung cancer patients compared with video-assisted thoracoscopic surgery (VATS) and open thoracotomy.

A comprehensive search for studies that compared RATS versus VATS or open thoracotomy published until 12 April 2022, was conducted. Two review authors independently assessed studies for inclusion and risk of bias, and extracted data. We used results of reported perioperative outcomes, oncological outcomes, and survival outcomes. When more than two studies contributed data, meta-analyses were performed.

Four randomized controlled trials (RCT) were included. Firstly, three RCTs comparing RATS with VATS were identified. Compared with the VATS group, the RATS group had significantly lower blood loss, more harvested lymph nodes and lymph node stations. However, there were no significant differences in operative time, transfusion rates, hospital stay, drainage duration, reoperation, readmission, postoperative pain, and postoperative complications. Survival outcomes were not reported. Secondly, one RCT comparing RATS with open thoracotomy was identified. Compared with open thoracotomy group, the RATS group had significantly lower blood loss, less postoperative pain, and shorter chest drainage duration. On the other hand, there were no significant differences in operative time, hospital stay, postoperative complications, number of harvested lymph nodes and lymph node stations, and survival outcomes (disease-free survival, overall survival).

Evidence on the effectiveness and safety of RATS compared with VATS or open thoracotomy for lung cancer is of low certainty, but we suggest that RATS is a feasible and safe alternative to conventional thoracic surgeries for lung cancer patients on the basis of current data. Additionally, more and better studies are required to provide evidence on the benefits and cost-effectiveness of RATS.

Phelan-McDermid syndrome (PMS) is a chromosomal disorder caused by the loss of the end of chromosome 22, that is manifested as a neurodevelopmental disorder. Providing an adapted version of a guideline was seen as essential, as currently, there are no such booklets based on an international guideline for PMS patients, families and caregivers. The European Reference Networks (ERN) Guidelines programme results from a call for proposals funded (DG SANTE/2018/B3/030) for the development of Clinical Practice Guidelines (CPG) and Clinical Decision Tools in the area of rare diseases. Based on this European consortium, the purpose of this study is to describe how two Spanish HTA agencies, OSTEBA-BIOEF (Basque Office for Health Technology Assessment) and AETSA (Andalusian Health Quality Assessment Department) methodologically support the ERN-ITHACA (Rare malformation syndromes and rare intellectual and neurodevelopmental disorders) in the development of a comprehensive patient booklet based on a CPG to be used as an adjunct in the management of PMS syndrome that will be published in 2023.

A preliminary booklet was created by HTA agencies using the new European guideline for PMS and a Dutch guideline. The booklet structure is an adaptation based on a European Commission template with the guidance of the methodological Handbook#11.

Through a comprehensive adaptation, following the PMS guideline and the Handbook #11, a booklet is developed for the PMS patients. Composed by 28 pages in DIN A5 format were introduction, diagnosis, treatment, pregnancy, do’s, supportive care, social networks (including a QR code) and a glossary are included. The selection of a symbol, colors at a chromatic level, a typography and graphical elements as illustrations were created as a corporate identity. Clinical experts and patient representatives that have participated in the creation of the guideline will assess and validate the booklet.

Collaboration between agencies, clinicians and patients is critical to obtain evidence-based products adapted to the needs of patients and people involved in their care.

Extracorporeal shock wave therapy (ESWT) has been used since the 1990s to treat various musculoskeletal disorders, but there is considerable controversy regarding the effectiveness of ESWT. Our aim was to conduct a systematic review of randomized controlled trials (RCT) to investigate the effectiveness of ESWT for plantar fasciitis.

A comprehensive search was conducted via electronic databases including MEDLINE, Embase, the Cochrane Controlled trials register, and 5 Korean databases from inception date to April 2022. Two review authors independently assessed studies for inclusion and risk of bias, and extracted study data. Major outcomes were pain relief, function, and quality of life.

We identified a total of 48 RCTs comparing ESWT with corticosteroid injection (n=14), conventional therapies (n=19), and sham control (n=21). Most studies included participants with chronic heel pain diagnosed as plantar fasciitis. All trials were susceptible to bias. In terms of pain results, ESWT showed no significant difference when compared with the steroid injection group and the conventional therapy group, and significant pain relief was confirmed only compared to the sham control group (Mean Difference -1.71; 95% confidence interval [CI] -2.44,-0.98; I2=70%;). Functional outcomes were significantly improved in the ESWT group compared to the steroid injection group (standardized mean difference 0.45; 95% CI 0.27,0.63; I2=0%) and the sham control group (SMD 0.84, 95% CI 0.23,1.45; I2=91%), but no significant difference was found when compared to the conventional therapy group.

Based upon the currently available low certainty evidence because of wide clinical diversity and varying treatment protocols of included trials, ESWT is associated with improved function and may be associated with pain reduction in plantar fasciitis. Further evidence is needed from well-designed studies with a standard dose and treatment protocol.

Depression is a general term that describes different depressive disorders which are highly prevalent and disabling, characterized by decreases in quality of life. Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain modulation technique used, among other purposes, for the treatment of chronic pain and headache. In order to clarify the effect of this stimulation on depressive disorders, the objective of this review was to evaluate efficacy and safety of treatment with tDCS for depressive disorders.

A systematic research study was carried out on 30 June 2022 in MEDLINE (by Pubmed), Embase, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), PsycInfo e Global Mental Health databases. Were included systematic reviews (SR) with meta-analysis that selected patients with depression, in use of tDCS, using as comparator sham stimulation (placebo) or any other treatment (pharmacologic or no) or any comparison between pre-and post-intervention.

Eight SR with meta-analysis of randomized clinical trials (RCTs) on the efficacy and safety of tDCS in the treatment of depressive disorders were retrieved. Subjects were assessed for clinical response, remission, change in scores on depression scales, occurrence of procedure-related adverse events, and treatment dropout. Three systematic reviews showed results that point to the effectiveness of tDCS for the clinical response outcome and one considering the remission outcome. As for the outcome measured by the change in depression scale scores, all included reviews showed favorable results for tDCS. It is noteworthy that the studies included in the reviews have methodological limitations. With regard to safety, an increased risk treatment-emergent mania or hypomania (TEM) has been observed.

The tDCS association with antidepressants showed favorable results to this technology in a sample with depression and varied clinical characteristics. Regarding safety of this technology, tDCS did not show adverse effects of greater severity, but was verified to have an increased risk of TEM.

Developed in 2014, the Systematic Review (SR) Toolbox has played a critical role in helping researchers to identify appropriate tools to support systematic reviews. Since the resource was launched, the systematic review and wider evidence synthesis process has evolved considerably. The way in which the SR Toolbox originally classified tools at launch had become dated. We updated and rebuilt the SR Toolbox in 2022 underpinned by a novel taxonomy to reflect the latest review and evidence synthesis landscape.

All guidance and software tools contained within the SR Toolbox were manually extracted in February 2022. Information contained from tool records were extracted by a single reviewer into an Excel spreadsheet, with a second reviewer checking a sample. The spreadsheet was translated to a Microsoft Access database underpinned with a new taxonomy to reflect the expansion of evidence synthesis methods and new review types (or ‘families’). A brief analysis of the remapped tools was conducted to identify current gaps in software and guidance support for evidence synthesis. A new user interface was also developed.

The updated version of the SR Toolbox was launched 13 May 2022. At that time, the resource included records on 235 software tools and 112 guidance tools. Regarding ‘review families’, most software tools (n = 223) and guidance documents (n = 78) were applicable to supporting systematic reviews. Fewer software (n = 66) and guidance (n = 22) tools were applicable to reviews of reviews, while qualitative reviews were less served by guidance documents (n = 19). In terms of ‘review stages’, most guidance documents were associated with quality assessment (n = 70), while most software was related to searching (n = 84) and synthesis (n = 82). To-date, there is a lack of software (n = 2) and guidance (n = 3) tools to support stakeholder engagement.

The SR Toolbox has received a significant update to ensure that tools are classified and shared based on the latest systematic review and evidence synthesis methods. As part of the update, analysis of the contents of the toolbox highlighted potential gaps in tool support for certain review types/stages.