Evaluation of Methods for the Inclusion of Real World Evidence in Network Meta-Analysis – A Case Study in Multiple Sclerosis

Jenkins, David; Czachorowski, M; Bujkiewicz, Sylwia; Dequen, P.; Jónsson, Páll; Abrams, Keith R.

doi:10.1016/j.jval.2014.08.1941

Cited by 8 publications

(3 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although treatments demonstrate comparable effectiveness in randomized controlled trials, it's crucial to recognize that trial participants are a selectively motivated and highly adherent group. As a result, findings from clinical trials may not consistently represent the broader characteristics of the general population (89,90).…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of basal insulins in people with type 2 diabetes mellitus: a systematic review and network meta-analysis of randomized clinical trials

Dehghani,

Sadeghi,

Barzkar

et al. 2024

Front. Endocrinol.

View full text Add to dashboard Cite

AimThe comparative effectiveness of basal insulins has been examined in several studies. However, current treatment algorithms provide a list of options with no clear differentiation between different basal insulins as the optimal choice for initiation.MethodsA comprehensive search of MEDLINE, Embase, Cochrane Library, ISI, and Scopus, and a reference list of retrieved studies and reviews were performed up to November 2023. We identified phase III randomized controlled trials (RCTs) comparing the efficacy and safety of basal insulin regimens. The primary outcomes evaluated were HbA1c reduction, weight change, and hypoglycemic events. The revised Cochrane ROB-2 tool was used to assess the methodological quality of the included studies. A random-effects frequentist network meta-analysis was used to estimate the pooled weighted mean difference (WMD) and odds ratio (OR) with 95% confidence intervals considering the critical assumptions in the networks. The certainty of the evidence and confidence in the rankings was assessed using the GRADE minimally contextualized approach.ResultsOf 20,817 retrieved studies, 44 RCTs (23,699 participants) were eligible for inclusion in our network meta-analysis. We found no significant difference among various basal insulins (including Neutral Protamine Hagedorn (NPH), ILPS, insulin glargine, detemir, and degludec) in reducing HbA1c. Insulin glargine, 300 U/mL (IGlar-300) was significantly associated with less weight gain (mean difference ranged from 2.9 kg to 4.1 kg) compared to other basal insulins, namely thrice-weekly insulin degludec (IDeg-3TW), insulin degludec, 100 U/mL (IDeg-100), insulin degludec, 200 U/mL (IDeg-200), NPH, and insulin detemir (IDet), but with low to very low certainty regarding most comparisons. IDeg-100, IDeg-200, IDet, and IGlar-300 were associated with significantly lower odds of overall, nocturnal, and severe hypoglycemic events than NPH and insulin lispro protamine (ILPS) (moderate to high certainty evidence). NPH was associated with the highest odds of overall and nocturnal hypoglycemia compared to others. Network meta-analysis models were robust, and findings were consistent in sensitivity analyses.ConclusionThe efficacy of various basal insulin regimens is comparable. However, they have different safety profiles. IGlar-300 may be the best choice when weight gain is a concern. In contrast, IDeg-100, IDeg-200, IDet, and IGlar-300 may be preferred when hypoglycemia is the primary concern.

show abstract

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of basal insulins in people with type 2 diabetes mellitus: a systematic review and network meta-analysis of randomized clinical trials

Dehghani,

Sadeghi,

Barzkar

et al. 2024

Front. Endocrinol.

View full text Add to dashboard Cite

show abstract

“…Our simulation study has shown that the standard NMA approach can be useful when using moderately informative priors on d. Moderately informative priors can be used for incorporating information from observational data or non randomized trials in the evidence base for a network meta-analysis (Schmitz et al, 2013;Jenkins et al, 2014;Zhang et al, 2019;Sutton and Abrams, 2001;Mak et al, 2009;Salpeter et al, 2009). In our simulation study, we observed ratios of posterior to prior variance in the range of 0.5 to 0.75 for disconnected contrasts with a sample size of 1000 and 0.55 to 0.8 for a sample size of 15.…”

Section: Discussionmentioning

confidence: 99%

A Theoretical Investigation of How Evidence Flows in Bayesian Network Meta-Analysis of Disconnected Networks

Béliveau

Gustafson

2021

Bayesian Anal.

View full text Add to dashboard Cite

Network meta-analysis has gained popularity in the last decade as a method for comparing the efficacy/safety of multiple medical interventions by synthesizing data across clinical studies. Bayesian methods for network meta-analysis have undergone further development than frequentist methods and are more convenient to use. Most of the current literature pertains to connected networks but disconnected networks commonly arise. There is not at the moment a trusted gold-standard approach to analyze disconnected networks. Intuitively, the standard method for analyzing connected networks, which is contrast-based, does not seem useful in disconnected networks, but this has not been explained rigorously. Our work is the first to provide the theoretical groundwork for understanding how evidence flows within Bayesian contrast-based models of disconnected networks. We achieve this by quantifying the ratio of posterior to prior variance of disconnected treatment contrasts. We show that when using an uninformative prior on the treatment contrasts, the standard approach is not useful to analyze disconnected networks (even when the number of studies, treatments or patients is large); however, it can be useful under moderately informative priors, which can be informed from additional observational data when available. A simulation study provides a demonstration of the theoretical results and explores non-asymptotic cases. An illustration on a real-world dataset is provided.

show abstract

“…Important are the discussions about methodology for data collection, quality of the data and usage for decision-making. A discussion about methods how to enable implementation of RWD into network meta-analyses supporting regulatory or reimbursement decisions was published by D. Jenkins, M. Czachorowski, S. Bujkiewicz et al 15 . Related to methods and quality of data is the issue of representative sample.…”

Section: Do We Need Real World Data? Polish Ispor Chapter Therapeutic...mentioning

confidence: 99%

Do we need real world data? Polish ISPOR Chapter Therapeutic Programs, Pharmaceutical Care and Pharmaceutical Law Section (TPPCPL) initial discussion

Drozd¹,

Szkultecka-Dębek²

2014

Journal of Health Policy &Amp; Outcomes Research

View full text Add to dashboard Cite

Objective: to discuss potential areas for use and sources of real world data in relation to medical treatment. Methods: we performed Pub-Med and an internet based search in literature for definitions, sources and examples of real world data use. Results: we identified 13 publications fitting our search criteria and we found that there are not many full publications related to real world data even if they can provide significant additional information regarding patient related outcomes, resources use, costs and the effect of therapies in a non-controlled environment and on broader populations than those from randomized clinical trials. Conclusion: Real world data can provide additional information in relation to medical treatments however there is a need to focus attention on methodology of data collection, data quality, potential sources of data and ensure proper legal environment for data collection. Unfortunately, despite large number of publications identified in PubMed database, there are only few available in a form of full text papers, the majority of publications are only abstracts from scientific conferences. In the future in order to share RWD experience it will be of benefit to encourage authors to work on full publications and not to limit their work only to abstracts.

show abstract

Evaluation of Methods for the Inclusion of Real World Evidence in Network Meta-Analysis – A Case Study in Multiple Sclerosis

Cited by 8 publications

References 9 publications

Efficacy and safety of basal insulins in people with type 2 diabetes mellitus: a systematic review and network meta-analysis of randomized clinical trials

Efficacy and safety of basal insulins in people with type 2 diabetes mellitus: a systematic review and network meta-analysis of randomized clinical trials

A Theoretical Investigation of How Evidence Flows in Bayesian Network Meta-Analysis of Disconnected Networks

Do we need real world data? Polish ISPOR Chapter Therapeutic Programs, Pharmaceutical Care and Pharmaceutical Law Section (TPPCPL) initial discussion

Contact Info

Product

Resources

About