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1دورية أكاديمية
المؤلفون: Bérengère Macabeo, Arthur Quenéchdu, Samuel Aballéa, Clément François, Laurent Boyer, Philippe Laramée
المصدر: Journal of Market Access & Health Policy, Vol 12, Iss 2, Pp 58-80 (2024)
مصطلحات موضوعية: systematic literature review (SLR), indirect treatment comparison (ITC), oncology, network meta-analysis (NMA), Bucher, matching-adjusted indirect comparison (MAIC), Public aspects of medicine, RA1-1270, Business, HF5001-6182
الوصف: Introduction: Health technology assessment (HTA) agencies express a clear preference for randomized controlled trials when assessing the comparative efficacy of two or more treatments. However, an indirect treatment comparison (ITC) is often necessary where a direct comparison is unavailable or, in some cases, not possible. Numerous ITC techniques are described in the literature. A systematic literature review (SLR) was conducted to identify all the relevant literature on existing ITC techniques, provide a comprehensive description of each technique and evaluate their strengths and limitations from an HTA perspective in order to develop guidance on the most appropriate method to use in different scenarios. Methods: Electronic database searches of Embase and PubMed, as well as grey literature searches, were conducted on 15 November 2021. Eligible articles were peer-reviewed papers that specifically described the methods used for different ITC techniques and were written in English. The review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: A total of 73 articles were included in the SLR, reporting on seven different ITC techniques. All reported techniques were forms of adjusted ITC. Network meta-analysis (NMA) was the most frequently described technique (in 79.5% of the included articles), followed by matching-adjusted indirect comparison (MAIC) (30.1%), network meta-regression (24.7%), the Bucher method (23.3%), simulated treatment comparison (STC) (21.9%), propensity score matching (4.1%) and inverse probability of treatment weighting (4.1%). The appropriate choice of ITC technique is critical and should be based on the feasibility of a connected network, the evidence of heterogeneity between and within studies, the overall number of relevant studies and the availability of individual patient-level data (IPD). MAIC and STC were found to be common techniques in the case of single-arm studies, which are increasingly being conducted in oncology and rare diseases, whilst the Bucher method and NMA provide suitable options where no IPD is available. Conclusion: ITCs can provide alternative evidence where direct comparative evidence may be missing. ITCs are currently considered by HTA agencies on a case-by-case basis; however, their acceptability remains low. Clearer international consensus and guidance on the methods to use for different ITC techniques is needed to improve the quality of ITCs submitted to HTA agencies. ITC techniques continue to evolve quickly, and more efficient techniques may become available in the future.
وصف الملف: electronic resource
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2دورية أكاديمية
المؤلفون: Qing-Feng Tao, Yan-Bing Huang, Lu Yuan, Yun-Zhou Shi, Di Qin, Kun Ye, Wen-Yan Peng, Chao-Rong Xie, Hui Zheng
المصدر: The Journal of Headache and Pain, Vol 25, Iss 1, Pp 1-11 (2024)
مصطلحات موضوعية: Acupuncture, Tricyclic antidepressants, Tension-type headache, Indirect treatment comparison, Meta-analysis, Medicine
الوصف: Abstract Background Acupuncture showed better improvement than sham acupuncture in reducing attack frequency of tension-type headache (TTH), but its effectiveness relative to first-line drugs for TTH is unknown, which impedes the recommendation of acupuncture for patients who are intolerant to drugs for TTH. We aimed to estimate the relative effectiveness between acupuncture and tricyclic antidepressants (TCAs) through indirect treatment comparison (ITC) meta-analysis. Methods We searched Ovid Medline, Embase, and Cochrane Library from database inception until April 13, 2023. Randomized controlled trials of TCAs or acupuncture in the prevention of TTH in adults were included. The primary outcome was headache frequency. The secondary outcomes were headache intensity, responder rate, and adverse event rate. Bayesian random-effect models were used to perform ITC meta-analysis, and confidence of evidence was evaluated by using the GRADE approach. Results A total of 34 trials involving 4426 participants were included. Acupuncture had similar effect with TCAs in decreasing TTH frequency (amitriptyline: mean difference [MD] -1.29, 95% CI -5.28 to 3.02; amitriptylinoxide: MD -0.05, 95% CI -6.86 to 7.06) and reducing TTH intensity (amitriptyline: MD 2.35, 95% CI -1.20 to 5.78; clomipramine: MD 1.83, 95% CI -4.23 to 8.20). Amitriptyline had a higher rate of adverse events than acupuncture (OR 4.73, 95% CI 1.42 to 14.23). Conclusion Acupuncture had similar effect as TCAs in reducing headache frequency of TTH, and acupuncture had a lower adverse events rate than amitriptyline, as shown by very low certainty of evidence.
وصف الملف: electronic resource
العلاقة: https://doaj.org/toc/1129-2377Test
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3دورية أكاديمية
المؤلفون: Monday L, Tillotson G, Chopra T
المصدر: Infection and Drug Resistance, Vol Volume 17, Pp 623-639 (2024)
مصطلحات موضوعية: clostridioides difficile infection, microbiome, microbiome therapeutic, indirect treatment comparison, Infectious and parasitic diseases, RC109-216
الوصف: Lea Monday,1 Glenn Tillotson,2 Teena Chopra1 1Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, MI, USA; 2GlennTillotson PhD, FIDSA, GSTMicro, Henrico, VA, USACorrespondence: Lea Monday, Harper University Hospital, Division of Infectious Diseases, 3990 John R Street, 5 Hudson, Suite 5911, Detroit, MI, 48201, USA, Tel +1 734-344-8392, Fax +1 313-9930302, Email lmonday@med.wayne.eduAbstract: Clostridioides difficile infection (CDI) remains a significant contributor to healthcare costs and morbidity due to high rates of recurrence. Currently, available antibiotic treatment strategies further disrupt the fecal microbiome and do not address the alterations in commensal flora (dysbiosis) that set the stage for CDI. Advances in microbiome-based research have resulted in the development of new agents, classified as live biotherapeutic products (LBPs), for preventing recurrent CDI (rCDI) by restoring eubiosis. Prior to the LBPs, fecal microbiota transplantation (FMT) was available for this purpose; however, lack of large-scale availability and safety concerns have remained barriers to its widespread use. The LBPs are an exciting development, but questions remain. Some are derived directly from human stool while other developmental products contain a defined microbial consortium manufactured ex vivo, and they may be composed of either living bacteria or their spores, making it difficult to compare members of this heterogenous drug class to one another. None have been studied head-to head or against FMT in preventing rCDI. As a class, they have considerable variability in their biologic composition, biopharmaceutic science, route of administration, stages of development, and clinical trial data. This review will start by explaining the role of dysbiosis in CDI, then give the details of the biopharmaceutical components for the LBPs which are approved or in development including how they differ from FMT and from one another. We then discuss the clinical trials of the LBPs currently approved for rCDI and end with the future clinical directions of LBPs beyond C. difficile.Keywords: Clostridioides difficile infection, microbiome, microbiome therapeutic, indirect treatment comparison
وصف الملف: electronic resource
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4دورية أكاديمية
المؤلفون: Shahrul Mt-Isa, Justin R. Chumbley, Emma L. Crawford, Natalie Banniettis, Ulrike K. Buchwald, Jessica Weaver, Thomas Weiss
المصدر: Expert Review of Vaccines, Vol 22, Iss 1, Pp 906-917 (2023)
مصطلحات موضوعية: maic, indirect treatment comparison, pneumococcal conjugate vaccine, immunoglobulin g, immunogenicity, pcv15, gmc ratio, igg response rate, Internal medicine, RC31-1245
الوصف: Objectives Immunogenicity between 15-valent V114 (PCV15) and 20-valent PCV20 pneumococcal conjugate vaccines in healthy infants is compared in an indirect treatment comparison and matching-adjusted indirect comparison. Hypotheses: immunogenicity of V114 is non-inferior to PCV20 for all PCV13 serotypes, and superior to PCV20 for serotype 3 based on lower bound margins. Methods Two phase 3 pivotal studies on 3 + 1 pediatric vaccination schedule at age 2, 4, 6, and 12–15 months compared V114 (N = 858) to PCV13 (N = 856) and PCV20 (N = 1001) to PCV13 (N = 987). Infant’s age and race in V114 study were matched to those in PCV20 study. Primary endpoints were serotype-specific Immunoglobulin G (IgG) response rate difference (RRD) 30 days post-dose (PD)3; IgG geometric mean concentration (GMC) ratios 30 days PD3 and PD4. Results V114 was non-inferior (${\rm{margi}}{{\rm{n}}_{RRD}}$>-10%-point; ${\rm{margi}}{{\rm{n}}_{GMCratio}}$ >0.5) to PCV20 (p-value 0%-point; ${\rm{margi}}{{\rm{n}}_{GMCratio}}$ >1.2) to PCV20 (p-value
وصف الملف: electronic resource
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5دورية أكاديمية
المؤلفون: Maureen Watt, Mia Malmenas, Katrin Haeussler
المصدر: Journal of Comparative Effectiveness Research, Vol 13, Iss 5 (2024)
مصطلحات موضوعية: berotralstat, comparative effectiveness, hereditary angioedema, indirect treatment comparison, lanadelumab, prophylaxis, Public aspects of medicine, RA1-1270
وصف الملف: electronic resource
العلاقة: https://doaj.org/toc/2042-6313Test
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6دورية أكاديمية
المؤلفون: Joseph Biskupiak, Gary Oderda, Diana Brixner, Todd L Wandstrat
المصدر: Journal of Comparative Effectiveness Research, Vol 13, Iss 5 (2024)
مصطلحات موضوعية: fentanyl, hydromorphone, indirect treatment comparison, morphine, nausea and vomiting, oliceridine, pain management, Public aspects of medicine, RA1-1270
الوصف: Background: In the absence of head-to-head comparative data from randomized controlled trials, indirect treatment comparisons (ITCs) may be used to compare the relative effects of treatments versus a common comparator (either placebo or active treatment). For acute pain management, the effects of oliceridine have been compared in clinical trials to morphine but not to fentanyl or hydromorphone. Aim: To assess the comparative safety (specifically differences in the incidence of nausea, vomiting and opioidinduced respiratory depression [OIRD]) between oliceridine and relevant comparators (fentanyl and hydromorphone) through ITC analysis. Methods: A systematic literature review identified randomized clinical trials with oliceridine versus morphine and morphine versus fentanyl or hydromorphone. The ITC utilized the common active comparator, morphine, for the analysis. Results: A total of six randomized controlled trials (oliceridine – 2; hydromorphone – 3; fentanyl – 1) were identified for data to be used in the ITC analyses. The oliceridine data were reported in two studies (plastic surgery and orthopedic surgery) and were also reported in a pooled analysis. The ITC focused on nausea and vomiting due to limited data for OIRD. When oliceridine was comparedwith hydromorphone in the ITC analysis, oliceridine significantly reduced the incidence of nausea and/or vomiting requiring antiemetics compared with hydromorphone (both orthopedic surgery and pooled data), while results in plastic surgery were not statistically significant. When oliceridine was compared with hydromorphone utilizing data from Hong, the ITC only showed a trend toward reduced risk of nausea and vomiting with oliceridine that was not statistically significant across all three comparisons (orthopedic surgery, plastic surgery and combined). An ITC comparing oliceridine with a study of fentanyl utilizing the oliceridine orthopedic surgery data and combined orthopedic and plastic surgery data showed a trend toward reduced risk that was not statistically significant. Conclusion: In ITC analyses, oliceridine significantly reduced the incidence of nausea and/or vomiting or the need for antiemetics in orthopedic surgery comparedwith hydromorphone and a non-significant trend toward reduced risk versus fentanyl.
وصف الملف: electronic resource
العلاقة: https://doaj.org/toc/2042-6313Test
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7دورية أكاديمية
المؤلفون: April W. Armstrong, Richard B. Warren, Yichen Zhong, Joe Zhuo, Allie Cichewicz, Ananth Kadambi, Daniela Junqueira, Tracy Westley, Renata Kisa, Carolin Daamen, Matthias Augustin
المصدر: Dermatology and Therapy, Vol 13, Iss 11, Pp 2839-2857 (2023)
مصطلحات موضوعية: Biologics, Deucravacitinib, Indirect treatment comparison, Network meta-analysis, Non-biologics, Psoriasis, Dermatology, RL1-803
الوصف: Abstract Introduction Deucravacitinib, a newly approved oral medication for the treatment of patients with moderate to severe plaque psoriasis, demonstrated efficacy versus apremilast and placebo in two phase 3 randomized controlled trials (RCTs). A systematic review and network meta-analysis (NMA) indirectly compared deucravacitinib with other relevant systemic biologic/nonbiologic treatments. Methods Online databases were searched for RCTs published through October 2021. Eligible studies were head-to-head comparisons between systemic therapies and/or placebo reporting 50%, 75%, 90%, or 100% improvement in Psoriasis Area and Severity Index (PASI) from baseline in adults with moderate to severe plaque psoriasis. Comparisons included tumor necrosis factor inhibitors, interleukin (IL)-17, IL-23, and IL 12/23 inhibitors, and systemic nonbiologics. A multinomial Bayesian NMA was used to derive estimates of the relative efficacy of deucravacitinib and other systemic therapies. Response probabilities for each treatment and corresponding 95% credible intervals (CrIs) for achieving a PASI response were calculated over short-, mid-, and long-term follow-up (weeks 10–16, 24–28, and 44–60). Results The NMA included 47 RCTs. Deucravacitinib showed the highest PASI 75 response rates among nonbiologic systemic therapies across time points. Deucravacitinib PASI 75 response rate (95% CrI) over short-term follow-up was 54.1% (46.5–61.6), within the range of first-generation biologics (etanercept, 39.7% [31.6–48.3]; infliximab, 79.0% [74.0–83.5]). At mid-term follow-up, deucravacitinib PASI 75 increased to 63.3% (58.0–68.4). At long-term follow-up, deucravacitinib PASI 75 was 65.9% (58.0–73.4), comparable to first-generation biologics adalimumab (62.8%; 55.3–69.6) and ustekinumab (68.0%; 64.6–71.5). Conclusions Patients receiving deucravacitinib were more likely to achieve PASI 75 response versus apremilast and methotrexate across all time points. The long-term PASI 75 response rate for deucravacitinib was similar to those of adalimumab and ustekinumab. The approval of deucravacitinib offers patients the choice of an oral therapy with long-term efficacy similar to that of some biologics.
وصف الملف: electronic resource
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8دورية أكاديمية
المؤلفون: Hess, Georg, Dreyling, Martin, Oberic, Lucie, Gine, Eva, Zinzani, Pier Luigi, Linton, Kim, Vilmar, Adam, Jerkeman, Mats, Chen, Jenny M.H., Ohler, Anke, Stilgenbauer, Stephan, Thieblemont, Catherine, Lambert, Jonathan, Zilioli, Vittorio Ruggero, Sancho, Juan Manuel, Jimenez-Ubieto, Ana, Fischer, Luca, Eyre, Toby A., Keeping, Sam, Park, Julie E., Wu, James J., Nunes, Ana, Reitan, John, Wade, Sally W., Salles, Gilles
المصدر: Hess , G , Dreyling , M , Oberic , L , Gine , E , Zinzani , P L , Linton , K , Vilmar , A , Jerkeman , M , Chen , J M H , Ohler , A , Stilgenbauer , S , Thieblemont , C , Lambert , J , Zilioli , V R , Sancho , J M , Jimenez-Ubieto , A , Fischer , L , Eyre , T A , Keeping , S , Park , J E , Wu , J J , Nunes , A , Reitan , J ....
مصطلحات موضوعية: brexucabtagene autoleucel, CAR T-cell therapy, indirect treatment comparison, mantle cell lymphoma, non-Hodgkin lymphoma, standard of care
الوصف: The SCHOLAR-2 retrospective study highlighted poor overall survival (OS) with standard of care (SOC) regimens among patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who failed a covalent Bruton tyrosine kinase inhibitor (BTKi). In the ZUMA-2 single-arm trial, brexucabtagene autoleucel (brexu-cel; autologous anti-CD19 CAR T-cell therapy) demonstrated high rates of durable responses in patients with R/R MCL who had previous BTKi exposure. Here, we compared OS in ZUMA-2 and SCHOLAR-2 using three different methods which adjusted for imbalances in prognostic factors between populations: inverse probability weighting (IPW), regression adjustment (RA), and doubly robust (DR). Brexu-cel was associated with improved OS compared to SOC across all unadjusted and adjusted comparisons. Hazard ratios (95% confidence intervals) were 0.38 (0.23, 0.61) for IPW, 0.45 (0.28, 0.74) for RA, and 0.37 (0.23, 0.59) for DR. These results suggest a substantial survival benefit with brexu-cel versus SOC in patients with R/R MCL after BTKi exposure.
الإتاحة: https://doi.org/10.1080/10428194.2023.2268228Test
https://research.manchester.ac.uk/en/publications/727ccf63-bee4-455b-8848-59d21916a07fTest
http://www.scopus.com/inward/record.url?scp=85174242231&partnerID=8YFLogxKTest -
9دورية أكاديمية
المؤلفون: Andreas Freitag, Laura Gurskyte, Grammati Sarri
المصدر: Journal of Comparative Effectiveness Research, Vol 12, Iss 10 (2023)
مصطلحات موضوعية: comparative effectiveness, effect modifier, health technology assessment, indirect treatment comparison, literature review, matching-adjusted indirect comparison, network meta-analysis, prognostic variable, simulated treatment comparison, Public aspects of medicine, RA1-1270
الوصف: Failure to adjust for effect modifiers (EMs) in indirect treatment comparisons (ITCs) can produce biased and uncertain effect estimates. This is particularly important for health technology assessments (HTAs), where the availability of new treatments is based on comparative effectiveness results. Much emphasis has been placed on advancing ITC methods to adjust for EMs, yet whether EMs are appropriately identified for the conduct of ITCs in the first place is unclear. To understand the extent of guidance and requirements for the selection of EMs for ITCs currently available and if and how this guidance is applied in practice, a series of pragmatic reviews of guidance documents from HTA and non-payer organizations, primary published ITC analyses, and prior HTA submissions in two indications (non-small cell lung cancer and psoriasis) was conducted. The reviews showed that current ITC guidance mainly focused on developing analytical methods to adjust for EMs. Some organizations, such as HTA bodies in the UK, France and Germany, recommended the use of literature reviews, expert opinion and statistical methods to identify EMs. No detailed guidance on the selection process or the appropriate literature review approach was found. Similar trends were identified through the database search and review of prior HTA submissions; only few published ITCs and submissions included information on the EM selection process which was either based on findings from the literature, trial subgroup analyses, or clinical input. No reference to a systematic selection approach was found. There is an urgent need to fill the guidance gap identified across the reviews by including a step in ITC guidelines on how EMs should be identified through systematic reviews, formal expert elicitation, and a quantitative assessment of the EM distribution. Researchers and manufacturers are also encouraged to improve transparent reporting and justification of their selection of EMs to allow for an independent review of the set of factors being considered for adjustment. Both will contribute toward reducing bias in the ITC results and ultimately increase confidence in decision-making.
وصف الملف: electronic resource
العلاقة: https://doaj.org/toc/2042-6313Test
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10دورية أكاديمية
المؤلفون: Jose Osorio, Sonia Maccioni, Reecha Sharma, Leena Patel, Paul Spin, Andrea Natale
المصدر: Journal of Comparative Effectiveness Research, Vol 12, Iss 9 (2023)
مصطلحات موضوعية: indirect comparison, indirect treatment comparison, paroxysmal atrial fibrillation, qdot, smarttouch, surround flow, thermocool, Public aspects of medicine, RA1-1270
الوصف: Aim: The objective of this study was to indirectly compare QDOT MICRO™ (QDOT), Thermocool R SmartTouch™ (ST) and Thermocool R SmartTouch R Surround Flow (STSF) to treat paroxysmal atrial fibrillation. Methods: Differences in baseline characteristics between study cohorts were reduced by reweighting patients using inverse probability of treatment weighting. The primary outcome was procedure time. Secondary outcomes were fluoroscopy time, clinical success at 12 months, and rhythm monitoring-adjusted recurrence. Results: QDOT was associated with significantly faster mean procedure and fluoroscopy time, and significant improvement in the rate of recurrence compared with pooled ST/STSF. No difference was observed for clinical success at 12 months. Conclusion: QDOT was associated with greater efficiency, greater effectiveness in rhythm monitoring-adjusted recurrence and similar effectiveness in clinical success at 12 months compared with pooled ST/STSF.
وصف الملف: electronic resource
العلاقة: https://doaj.org/toc/2042-6313Test
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