Evaluation of Risks of Bias in Addiction Medicine Randomized Controlled Trials

Abstract Aims Perhaps the most important step when designing and conducting randomized controlled trials (RCTs) in addiction is to put methodological safeguards in place to minimize the likelihood for bias to affect trial outcomes. In this study, we applied the revised Cochrane risk of bias tool (ROB 2) to RCTs of drug, alcohol or tobacco interventions. Methods We searched for trials published in 15 addiction medicine journals over a 7-year period. Our primary endpoint is the risk of bias of included studies. We conducted a sensitivity analysis of publicly funded trials. Results Overall, included RCTs were most often at high risk of bias per our judgments (244/487, 50.1%). However, significant proportions of included RCTs were at low risk of bias (123/487, 25.3%) or some concerns for bias (120/497, 24.6%). RCTs with behavioral modification interventions (19/44, 43.2%) and alcohol interventions (80/150, 53.3%) had the highest proportion of high-risk judgments. In a sensitivity analysis of publicly funded RCTs), 195/386 (50.5%) were at high risk of bias. Conclusions Approximately half of included drug, alcohol or tobacco RCTs in our sample were judged to be at high risk of bias with the most common reason being a lack of proper blinding or proper description of blinding. Key action items to reduce bias in future addiction RCTs include adequate randomization, blinding and inclusion of a trial registry number and protocol.

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A Scoping Review on the Use of Antibiotic-Impregnated Beads and Applications to Vascular Surgery

Vascular and Endovascular Surgery ◽

10.1177/1538574419886957 ◽

2019 ◽

Vol 54 (2) ◽

pp. 147-161 ◽

Cited By ~ 1

Author(s):

Brandon McGuinness ◽

Khatija Pinky Ali ◽

Steven Phillips ◽

Michael Stacey

Keyword(s):

High Risk ◽

Vascular Surgery ◽

Randomized Controlled Trials ◽

Scoping Review ◽

Graft Infection ◽

Risk Of Bias ◽

Controlled Trials ◽

High Risk Patients ◽

Randomized Controlled ◽

Risk Patients

Introduction: Surgical site infection (SSI) presents a ubiquitous concern to surgical specialties, especially in the presence of prosthetic material. Antibiotic-impregnated beads present a novel and evolving means to combat this condition. This review aims to analyze the quality of evidence and methods of antibiotic bead use, particularly for application within vascular surgery. Methods: A systematic scoping review was conducted within Embase, MEDLINE, and the Cochrane Registry of Randomized Controlled Trials. Articles were evaluated by 2 independent reviewers. Level of evidence was evaluated using the Oxford Center for Evidence-Based Medicine Criteria and the Cochrane Risk of Bias Tool for Randomized Controlled Trials. Results: The search yielded 6951 papers, with 275 included for final analysis. Publications increased in frequency from 1978 to the present. The most common formulation was polymethyl methacrylate; however publications on biodegradable formulations, including calcium sulfate beads, have been published with increasing frequency. Most publications had positive conclusions (94.2%); however, the data was mainly subjective and may be prone to publication bias. Only 11 randomized controlled trials were identified and all but one was evaluated to be at a high risk of bias. The most common indication was for osteomyelitis (52%), orthopedic prosthetic infections (20%), and trauma (9%). Within vascular surgery, beads have been used primarily for the treatment of graft infection, with freedom from recurrence rates being reported from 41% to 87.5%. Conclusions: Antibiotic-impregnated beads provide a means to deliver high doses of antibiotic directly to a surgical site, without the risks of parenteral therapy. There has yet to be significant high-level quality data published on their use. There is a large body of evidence that suggests antibiotic beads may be used in SSIs in high-risk patients, prosthetic infections, and other complex surgical infections. Important potential areas of application in vascular surgery include graft infection, prevention of wound infection in high-risk patients, and diabetic foot infection.

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Is reiki or prayer effective in relieving pain during hospitalization for cesarean? A systematic review and meta-analysis of randomized controlled trials

Sao Paulo Medical Journal ◽

10.1590/1516-3180.2016.0267031116 ◽

2017 ◽

Vol 135 (2) ◽

pp. 123-132 ◽

Cited By ~ 3

Author(s):

Guilherme Augusto Rago Ferraz ◽

Meline Rosseto Kron Rodrigues ◽

Silvana Andrea Molina Lima ◽

Marcelo Aparecido Ferraz Lima ◽

Gabriela Lopes Maia ◽

...

Keyword(s):

Systematic Review ◽

High Risk ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Spiritual Healing ◽

Risk Of Bias ◽

Controlled Trials ◽

Randomized Controlled ◽

Significant Difference ◽

Section Design

ABSTRACT CONTEXT AND OBJECTIVE: This systematic review compared reiki and prayer with drug use for relieving pain during hospitalization for cesarean, given that the popularity of integrative medicine and spiritual healing has been increasing. It had the aim of evaluating whether reiki or prayer is effective in relieving pain during cesarean section. DESIGN AND SETTING: Systematic review with meta-analysis conducted at Botucatu Medical School, UNESP, São Paulo, Brazil. METHODS: The following databases were searched up to March 2016: MEDLINE, Embase, LILACS and CENTRAL. Randomized controlled trials published in English or Portuguese were included in the review. Two reviewers independently screened eligible articles, extracted data and assessed the risk of bias. A GRADE table was produced to evaluate the risk of bias. RESULTS: There was evidence with a high risk of bias showing a statistically significant decrease in pain score through use of reiki and prayer, in relation to the protocol group: mean difference = -1.68; 95% confidence interval: -1.92 to -1.43; P < 0.00001; I2 = 92%. Furthermore, there was no statistically significant difference in heart rate or systolic or diastolic blood pressure. CONCLUSION: Evidence with a high risk of bias suggested that reiki and prayer meditation might be associated with pain reduction.

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The treatment of premenstrual syndrome with preparations of Vitex Agnus Castus (Chaste-berry): A systematic review and meta-analysis

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.1863 ◽

2017 ◽

Vol 41 (S1) ◽

pp. s907-s908

Author(s):

P. Schulte ◽

A. Verkaik ◽

A. Kamperman ◽

R. Van Westrhenen

Keyword(s):

High Risk ◽

Randomized Controlled Trials ◽

Premenstrual Syndrome ◽

Meta Analysis ◽

Risk Of Bias ◽

Reproductive Age ◽

Controlled Trials ◽

Extensive Literature ◽

Randomized Controlled ◽

Agnus Castus

IntroductionFive to 8% of women of reproductive age suffer from moderate to severe symptoms of premenstrual syndrome associated with substantial distress or functional impairment.ObjectiveTo determine the efficacy, tolerability and acceptability of Vitex agnus castus (VAC, chaste-berry) preparations for treatment of premenstrual syndrome (PMS).MethodsAfter an extensive literature search all randomized controlled trials of VAC in women with PMS and/or premenstrual dysphoric disorder were included.ResultsWe found 17 randomized controlled trials of VAC in the treatment of PMS of which 14 studies could be included in the quantitative analysis. All trials, except one, found the Vitex agnus castus preparation to be more efficacious than placebo, pyridoxine and magnesium for either total symptom score or individual symptoms or symptom clusters. Unfortunately, the majority of trials is hampered by a high risk of bias. The pooled effect of VAC in placebo-controlled trials was large (Hedge's g: −1.21; 95% CI: −1.53 to −0.88), but heterogeneity extremely high (I2 = 91%). We could not single out distinct factors that could explain this heterogeneity. The funnel plot and Egger's tests suggest the presence of bias over the full set of studies and effect sizes.ConclusionAlthough meta-analysis shows a large pooled effect of VAC in placebo-controlled trials the high risk of bias, high heterogeneity and risk of publication bias of the included studies preclude a definitive conclusion. The pooled treatment effects should be viewed as merely explorative and, at best, overestimating the real treatment effect of VAC for PMS symptomatology.Disclosure of interestP.S. reports personal fees from H. Lundbeck A/S, outside the submitted work. The other authors have not supplied their declaration of competing interest.

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Effectiveness of integrated nursing interventions for fatigue in patients with advanced cancer: a systematic review of randomized controlled trials

Frontiers of Nursing ◽

10.2478/fon-2019-0027 ◽

2019 ◽

Vol 6 (3) ◽

pp. 203-210

Author(s):

Xiao-Lin Zuo ◽

Yan Wen ◽

Shang-Qun Gong ◽

Fan-Jie Meng

Keyword(s):

Systematic Review ◽

High Risk ◽

Randomized Controlled Trials ◽

Advanced Cancer ◽

Intervention Group ◽

Risk Of Bias ◽

Cochrane Library ◽

Controlled Trials ◽

Nursing Interventions ◽

Randomized Controlled

Abstract Objective To evaluate the effectiveness of integrated nursing interventions for fatigue in patients with advanced cancer. Methods Medline, Pubmed, Embase, CINAHL, Web of Science, and the Cochrane Library were searched systematically till June 2017. A systematic review was conducted to collect randomized controlled trials (RCTs) reporting on the effect of nurse-driven interventions to improve fatigue in patients with advanced cancer. Quality assessment was conducted using the Cochrane Collaboration’s risk of bias tool. Results Six RCTs involving 736 adult participants were included. The fatigue intensity was improved significantly by nursing interventions. The analyzed results revealed significant improvements in the intervention group: less than 3 months (standard mean difference [SMD] = −0.33, 95% confidence interval [CI] [−0.48, −0.19], P < 0.01) and more than or equal to 3 months (SMD = −0.40, 95% CI [−0.57, −0.24], P < 0.01). Four studies with a moderate risk of bias were judged, and the remaining studies were at high risk of bias. Conclusions The results indicate that integrated nursing interventions may relieve fatigue in patients with advanced cancer. However, due to the high risk of bias in most of the included studies and the diversity of interventions, the results and implementation process should be carefully monitored.

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Assessment of Risk of Bias in Osteosarcoma and Ewing’s Sarcoma Randomized Controlled Trials: A Systematic Review

Current Oncology ◽

10.3390/curroncol28050322 ◽

2021 ◽

Vol 28 (5) ◽

pp. 3771-3794

Author(s):

Robert Koucheki ◽

Aaron M. Gazendam ◽

Jonathan R. Perera ◽

Anthony Griffin ◽

Peter Ferguson ◽

...

Keyword(s):

High Risk ◽

Randomized Controlled Trials ◽

Ewing’S Sarcoma ◽

Ewing's Sarcoma ◽

Conflicts Of Interest ◽

Risk Of Bias ◽

Controlled Trials ◽

Industry Funding ◽

Randomized Controlled ◽

Unclear Risk

Aim: The aim of this study was to systematically assess the risk of bias in osteosarcoma and Ewing’s sarcoma (ES) randomized controlled trials (RCT) and to examine the relationships between bias and conflict of interest/industry sponsorship. Methods: An OVID-MEDLINE search was performed (1976–2019). Using the Cochrane Collaboration guidelines, two reviewers independently assessed the prevalence of risk of bias in different RCT design domains. The relationship between conflicts of interest and industry funding with the frequency of bias was examined. Results: 73 RCTs met inclusion criteria. Prevalence of low-risk bias domains was 47.3%, unclear-risk domains 47.8%, and 4.9% of the domains had a high-risk of bias. Domains with the highest risk of bias were blinding of participants/personnel and outcome assessors, followed by randomization and allocation concealment. Overtime, frequency of unclear-risk of bias domains decreased (χ2 = 5.32, p = 0.02), whilst low and high-risk domains increased (χ2 = 8.13, p = 0.004). Studies with conflicts of interest and industry sponsorships were 4.2 and 3.1 times more likely to have design domains with a high-risk of bias (p < 0.05). Conclusion: This study demonstrates that sources of potential bias are prevalent in both osteosarcoma and ES RCTs. Studies with financial conflicts of interest and industry sponsors were significantly more likely to have domains with a high-risk of bias. Improvements in reporting and adherence to proper methodology will reduce the risk of bias and improve the validity of the results of RCTs in osteosarcoma and ES.

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Adjuvant Transarterial Chemoembolization Following Curative-Intent Hepatectomy Versus Hepatectomy Alone for Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Cancers ◽

10.3390/cancers13122984 ◽

2021 ◽

Vol 13 (12) ◽

pp. 2984

Author(s):

Stepan M. Esagian ◽

Christos D. Kakos ◽

Emmanouil Giorgakis ◽

Lyle Burdine ◽

J. Camilo Barreto ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Systematic Review ◽

Randomized Controlled Trials ◽

Transarterial Chemoembolization ◽

Meta Analysis ◽

Risk Of Bias ◽

Cochrane Library ◽

Controlled Trials ◽

Curative Intent ◽

Randomized Controlled

The role of adjuvant transarterial chemoembolization (TACE) for patients with resectable hepatocellular carcinoma (HCC) undergoing hepatectomy is currently unclear. We performed a systematic review of the literature using the MEDLINE, Embase, and Cochrane Library databases. Random-effects meta-analysis was carried out to compare the overall survival (OS) and recurrence-free survival (RFS) of patients with resectable HCC undergoing hepatectomy followed by adjuvant TACE vs. hepatectomy alone in randomized controlled trials (RCTs). The risk of bias was assessed using the Risk of Bias 2.0 tool. Meta-regression analyses were performed to explore the effect of hepatitis B viral status, microvascular invasion, type of resection (anatomic vs. parenchymal-sparing), and tumor size on the outcomes. Ten eligible RCTs, reporting on 1216 patients in total, were identified. The combination of hepatectomy and adjuvant TACE was associated with superior OS (hazard ratio (HR): 0.66, 95% confidence interval (CI): 0.52 to 0.85; p < 0.001) and RFS (HR: 0.70, 95% CI: 0.56 to 0.88; p < 0.001) compared to hepatectomy alone. There were significant concerns regarding the risk of bias in most of the included studies. Overall, adjuvant TACE may be associated with an oncologic benefit in select HCC patients. However, the applicability of these findings may be limited to Eastern Asian populations, due to the geographically restricted sample. High-quality multinational RCTs, as well as predictive tools to optimize patient selection, are necessary before adjuvant TACE can be routinely implemented into standard practice. PROSPERO Registration ID: CRD42021245758.

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Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials

Journal of Intensive Care ◽

10.1186/s40560-021-00563-7 ◽

2021 ◽

Vol 9 (1) ◽

Author(s):

Xiao-Li Chen ◽

Bei-Lei Zhang ◽

Chang Meng ◽

Hui-Bin Huang ◽

Bin Du

Keyword(s):

Sensitivity Analysis ◽

Randomized Controlled Trials ◽

Critically Ill Patients ◽

Oxygen Therapy ◽

Primary Outcome ◽

Meta Analysis ◽

Controlled Trials ◽

Icu Patients ◽

Randomized Controlled

Abstract Objective Conservative oxygen strategy is recommended in acute illness while its benefit in ICU patients remains controversial. Therefore, we sought to conduct a systematic review and meta-analysis to examine such oxygen strategies’ effect and safety in ICU patients. Methods We searched PubMed, Embase, and the Cochrane database from inception to Feb 15, 2021. Randomized controlled trials (RCTs) that compared a conservative oxygen strategy to a conventional strategy in critically ill patients were included. Results were expressed as mean difference (MD) and risk ratio (RR) with a 95% confidence interval (CI). The primary outcome was the longest follow-up mortality. Heterogeneity, sensitivity analysis, and publication bias were also investigated to test the robustness of the primary outcome. Results We included seven trials with a total of 5265 patients. In general, the conventional group had significantly higher SpO2 or PaO2 than that in the conservative group. No statistically significant differences were found in the longest follow-up mortality (RR, 1.03; 95% CI, 0.97–1.10; I2=18%; P=0.34) between the two oxygen strategies when pooling studies enrolling subjects with various degrees of hypoxemia. Further sensitivity analysis showed that ICU patients with mild-to-moderate hypoxemia (PaO2/FiO2 >100 mmHg) had significantly lower mortality (RR, 1.24; 95% CI, 1.05–1.46; I2=0%; P=0.01) when receiving conservative oxygen therapy. These findings were also confirmed in other study periods. Additional, secondary outcomes of the duration of mechanical ventilation, the length of stay in the ICU and hospital, change in sequential organ failure assessment score, and adverse events were comparable between the two strategies. Conclusions Our findings indicate that conservative oxygen therapy strategy did not improve the prognosis of the overall ICU patients. The subgroup of ICU patients with mild to moderate hypoxemia might obtain prognosis benefit from such a strategy without affecting other critical clinical results.

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The reporting of coenrolment in protocols of publicly funded randomized controlled trials was infrequent and variable

Journal of Clinical Epidemiology ◽

10.1016/j.jclinepi.2021.01.002 ◽

2021 ◽

Vol 133 ◽

pp. 94-100

Author(s):

Tanaya Maslekar ◽

Samuel Peat ◽

Jamshaid Karim ◽

Catherine Moriarty ◽

David G. Jayne ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Controlled Trials ◽

Publicly Funded ◽

Randomized Controlled

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Effects of Supervised Multimodal Exercise Interventions on Cancer-Related Fatigue: Systematic Review and Meta-Analysis of Randomized Controlled Trials

BioMed Research International ◽

10.1155/2015/328636 ◽

2015 ◽

Vol 2015 ◽

pp. 1-13 ◽

Cited By ~ 44

Author(s):

José Francisco Meneses-Echávez ◽

Emilio González-Jiménez ◽

Robinson Ramírez-Vélez

Keyword(s):

Systematic Review ◽

Resistance Training ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Risk Of Bias ◽

Controlled Trials ◽

Exercise Interventions ◽

Training Interventions ◽

Randomized Controlled ◽

Cancer Related Fatigue

Objective. Cancer-related fatigue (CRF) is the most common and devastating problem in cancer patients even after successful treatment. This study aimed to determine the effects of supervised multimodal exercise interventions on cancer-related fatigue through a systematic review and meta-analysis.Design. A systematic review was conducted to determine the effectiveness of multimodal exercise interventions on CRF. Databases of PubMed, CENTRAL, EMBASE, and OVID were searched between January and March 2014 to retrieve randomized controlled trials. Risk of bias was evaluated using the PEDro scale.Results. Nine studiesn=772were included in both systematic review and meta-analysis. Multimodal interventions including aerobic exercise, resistance training, and stretching improved CRF symptoms (SMD=-0.23; 95% CI: −0.37 to −0.09;P=0.001). These effects were also significant in patients undergoing chemotherapyP<0.0001. Nonsignificant differences were found for resistance training interventionsP=0.30. Slight evidence of publication bias was observedP=0.04. The studies had a low risk of bias (PEDro scale mean score of 6.4 (standard deviation (SD) ± 1.0)).Conclusion. Supervised multimodal exercise interventions including aerobic, resistance, and stretching exercises are effective in controlling CRF. These findings suggest that these exercise protocols should be included as a crucial part of the rehabilitation programs for cancer survivors and patients during anticancer treatments.

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