Comparative rates of harms in randomized trials from more developed versus less developed countries may be different

Contopoulos‐Ioannidis, Despina G.; Tseretopoulou, Xanthippi; Ancker, Megan; Walterspiel, Juan N.; Panagiotou, Orestis A.; Maldonado, Yvonne; Ioannidis, John P. A.

doi:10.1016/j.jclinepi.2016.02.032

Cited by 6 publications

(4 citation statements)

References 34 publications

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“…In contrast with the present study, more patients with Alzheimer’s disease in North America and Europe reported AEs than those in the RFEE and Japan [ 22 ]. Differences in AE reporting rates may reflect cultural differences across different geographical regions, such as relationships between patients and healthcare providers, access to healthcare providers and tolerance of pain and discomfort [ 19 , 21 , 23 ]. In addition, differences may be related to variability in the quality of the standard-of-care health practices and overall health and lifestyle factors [ 3 , 29 ].…”

Section: Discussionmentioning

confidence: 99%

“…One concern with the globalization of clinical trials is that efficacy or safety outcomes may differ based on the geographical region in which trials are conducted. Previous studies across multiple diseases (including mental illness, cardiovascular disease, gastrointestinal disease, breast cancer and Alzheimer’s disease) have reported that adverse event (AE) reporting rates and placebo (or standard-of-care arm) response may differ by geographical region and level of economic development [ 19–25 ]. However, it remains uncertain how broadly such geographical differences in AE reporting rates and outcomes may be generalizable across therapeutic indications, and only limited data are available related to the effect of regional differences in RA clinical trials.…”

Section: Introductionmentioning

confidence: 99%

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Regional variations in adverse event reporting rates and ACR responses in placebo/standard-of-care arms of rheumatoid arthritis trials

Keebler¹,

Teng²,

Chia³

et al. 2020

Rheumatology

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Objective Clinical trials are increasingly globalized, and adverse event (AE) rates and treatment responses may differ by geographical region. This study assessed regional differences in AE reporting rates and ACR response rates (ACR20/50) in patients with RA who received placebo/standard-of-care treatment in clinical trials. Methods Patients from the placebo arms of 7 RA trials in the TransCelerate Biopharma Inc database were grouped into 5 geographical regions (Asia, Latin America, Russian Federation and Eastern Europe [RFEE], USA, and Western Europe). Differences in demographics, AE reporting rates and ACR response were evaluated using descriptive statistics and omnibus tests for significance; pairwise comparisons were made between regions, with false discovery rate correction for multiple comparisons. Results Among 970 patients included, week 12 AE rates were significantly lower in the RFEE than in Asia, Latin America and the USA (22% vs 51%, 49% and 53%, respectively; P < 0.05 after false discovery rate correction). Similar differences in AE rates across geographical regions were seen at week 52. Among 747 patients with ACR data, the lowest response rates were observed in the USA (ACR20, 22%) and RFEE (ACR50, 3%); the highest response rates were seen in Western Europe (ACR20, 43%) and Latin America (ACR50, 15%). Only the differences in ACR50 response between the RFEE and Latin America remained significant after false discovery rate correction. Conclusion These placebo/standard-of-care arm data revealed significant regional differences in AE reporting rates and ACR50 response rates. Regional distribution of patients should be considered when conducting RA clinical trials, particularly during recruitment.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Regional variations in adverse event reporting rates and ACR responses in placebo/standard-of-care arms of rheumatoid arthritis trials

Keebler¹,

Teng²,

Chia³

et al. 2020

Rheumatology

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“…This means RCTs conducted in developed countries are more transparent in reporting SAAO-related harms. However, this contrasts with the results of Contopoulos-Ioannidis et al, who reported in their MES that poor reporting of harms is a global problem regardless of where the RCTs were conducted [ 20 ].…”

Section: Discussionmentioning

confidence: 65%

“…This lack of available information affects the transparency, and the reliability of the findings, as well as the decision to adopt the applied intervention [ 19 ]. Nowadays, few meta-epidemiological studies (MES) have touched on that item within the field of medicine [ 16 , 20 , 21 ]. On the other hand, regarding orthodontics, only one MES investigated the quality of reporting of RCTs abstracts in the four major orthodontic journals between 2006 and 2011 [ 22 ].…”

Section: Introductionmentioning

confidence: 99%

The transparency of reporting 'harms' encountered with the surgically assisted acceleration of orthodontic tooth movement in the published randomized controlled trials: a meta-epidemiological study

2023

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Background Surgical-assisted accelerated orthodontics (SAAO) has become very popular recently. Therefore, this study aimed to investigate the extent to which researchers adhere to Item 19 (harms) of the Consolidated Standards of Reporting Trials (CONSORT) in the published studies in the field of SAAO. In addition, the study evaluated the possible association between harm reporting and the human development index (HDI) of the recruited research sample country, CiteScore-based quartile (CSBQ) of the publishing journal, invasiveness of the surgical intervention (ISI), and the type of orthodontic tooth movement (TOTM). Moreover, it aimed to summarize the different possible harms and complications that maybe encountered in the course of SAAO. Materials and methods Electronic searching of six databases was conducted for SAAO-related English RCTs published between January 2000 and April 2022. For the RCTs that did not report harms, information was sought by contacting the corresponding authors. Descriptive statistics of the evaluated variables were performed. The association between 'harm reporting' and the HDI of the research team, the BDRQ of the publication journal, the ISI, and the TOTM were investigated. Binary logistic regression was used, and the odds ratios (ORs) with 95% confidence interval (CIs) of the evaluated variables were obtained. Moreover, the risk of bias of the included RCTs was assessed using the RoB2 tool. Results Among the 91 included RCTs, 54 RCTs (59.3%) did not adhere to reporting harm associated with the SAAO. The non-adherence was significantly associated with the ISI (OR 0.16; CI 0.03–0.73; p < 0.018) for invasive methods compared with minimally invasive ones). There was a significant positive correlation between harm reporting and both the CSBQ of the publishing journal and the HDI of the recruited research sample country (p = 0.001, p = 0.003, respectively). On the contrary, a non-significant association was found between harm reporting and the type of OTM (p = 0.695). The incidence of harms associated with SAAO was approximately 17.5%. Limitations Assessment was restricted to English RCTs related to SAAO. Conclusion and implications The adherence to reporting harms in the field of SAAO was deficient. Efforts should be made by authors, peer reviewers, and editors to improve compliance with the CONSORT guidelines regarding harms reporting. Additionally, there is a wide spectrum of harms that could be associated with SAAO that the practitioner should pay attention to and alert the patient to the possibility of their occurrence.

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Comparative evidence on harms in pediatric randomized clinical trials from less developed versus more developed countries is limited

Tedesco

Farid‐Kapadia

Offringa

et al. 2018

Journal of Clinical Epidemiology

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Comparative rates of harms in randomized trials from more developed versus less developed countries may be different

Cited by 6 publications

References 34 publications

Regional variations in adverse event reporting rates and ACR responses in placebo/standard-of-care arms of rheumatoid arthritis trials

Regional variations in adverse event reporting rates and ACR responses in placebo/standard-of-care arms of rheumatoid arthritis trials

The transparency of reporting 'harms' encountered with the surgically assisted acceleration of orthodontic tooth movement in the published randomized controlled trials: a meta-epidemiological study

Comparative evidence on harms in pediatric randomized clinical trials from less developed versus more developed countries is limited

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