scholarly journals Intervention for Married Immigrant Women in Korea: A Systematic Review

2021 ◽  
Vol 25 (2) ◽  
pp. 99-108
Author(s):  
Soo Jin Lee ◽  
Xianglan Jin ◽  
Sujin Lee
Keyword(s):  
Health Knowledge ◽  
Immigrant Women ◽  
Random Sequence ◽  
Health Belief ◽  
Well Being ◽  
Nursing Intervention ◽  
Outcome Data ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Intervention Programs

Purpose: This study aimed to review the intervention programs designed for married immigrant women living in Korea.Methods: A total of 39 articles published from 2010 to 2020 were selected and analyzed using domestic and international web-based academic databases according to a systematic literature review procedure. The selected studies were evaluated for quality according to RoB (Risk of Bias) and RoBANS (Risk of Bias for Non-randomized studies). Additionally, intervention programs and outcome variables were based on the Nursing Intervention Classification (NIC) and Nursing Outcome Classification (NOC) system.Results: According to the NIC categories, 69.2% of the interventions were in the behavioral domain, and 23.1% were in the family domain. The outcome variables primarily measured in NOC categories were psychological well-being (45.8%), health knowledge (11.0%), and health belief (10.2%). The quality of the selected studies was low overall in random sequence generation, allocation concealment, blinding of participants and personnel, and blinding of outcome data in randomized controlled trials (RCT) studies and confounding variables, blinding of outcome data, and incomplete outcome bias in non-RCT studies.Conclusion: Based on the results of this study, future studies will have to consider the characteristics of the subjects, life cycle, daily life, or language limitations. In addition, it is necessary to develop high-quality programs through continuous research on currently and frequently used interventions and outcome variables and on other various mediations and to verify the outcome variables.

scholarly journals The Risk of Bias in Iranian Randomized Controlled Trials Included in Cochrane Reviews

2020 ◽  
Author(s):  
Ali Kabir ◽  
Ahmad Sofi-Mahmudi ◽  
Arman Karimi Behnagh ◽  
Vahid Eidkhani ◽  
Hamid Reza Baradaran ◽  
...  
Keyword(s):  
Human Subjects ◽  
Random Sequence ◽  
Outcome Data ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Controlled Clinical Trial ◽  
Selective Reporting ◽  
Controlled Trials ◽  
Level Of Evidence ◽  
Cochrane Reviews

Background: Randomised controlled trials (RCT) provide the highest level of evidence among interventional studies. However, RCTs may be susceptible to the risk of bias (RoB). Therefore, systematic reviews appraise the RoB in all included studies in a review by using evaluation tools. This study aimed to describe the main characteristics of RCTs conducted in Iran and included in Cochrane Reviews (CRs) by focusing on their RoB. Methods: We searched "Iran" by selecting the "Search All Text" field and "Review" in the Cochrane Database of systematic Review within Ovid. We retrieved CRs that included Iranian controlled trials. We selected trials only if they had involved human subjects, described as a controlled clinical trial, included in CRs and therefore the review authors assessed their RoBs. The characteristics of trials have been extracted by looking at the table "Characteristics of included studies" in each CRs as well as the relevant papers. To addressing RoB, we collected the judgment of the review authors according to the table of RoB assessments in CRs. Results: There were 1166 Iranian RCTs included in 571 CRs. From all these studies, 44.9% were at low RoB for random sequence generation, 20.8% for allocation concealment, 32.3% for blinding of participants/personnel, 36.5% for blinding of outcome assessors, 56.3% for incomplete outcome data, 41.3% selective reporting, and 53.8% for other bias. Conclusion: RoB was mainly high or unclear in Iranian RCTs. Special attention must be paid to methodological quality of RCTs in Iran accordingly.

scholarly journals Impact of risk of bias on the magnitude of treatment effects of randomized controlled trials in implant dentistry

2020 ◽  
Author(s):  
Ruolin Ding ◽  
Wenxin Lu ◽  
Jianru Yi ◽  
Liang Zhang ◽  
Zhihe Zhao
Keyword(s):  
Randomized Controlled Trials ◽  
Treatment Effects ◽  
Permutation Test ◽  
Random Sequence ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Selective Reporting ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Implant Dentistry

Abstract Background: Risk of bias (RoB) could influence the magnitude of treatment effects of randomized controlled trials (RCTs). This study aims to investigate the potential influence of RoB on treatment effects estimates in RCTs in implant dentistry. Methods: The RCTs published in five leading oral implant journals during the recent five years were electronically searched. The RoB was assessed using the Cochrane Collaboration RoB tool. The meta-regression analysis and Monte Carlo permutation test were performed to identify the association between RoB and the magnitude of treatment effects.Results: A considerable amount of studies have high RoB in blinding of participants and personnel, and unclear RoB in allocation concealment and selective reporting. The treatment effects were exaggerated by flaws in allocation concealment for binary outcomes and by deficiencies in random sequence generation and selective reporting for continuous outcomes.Conclusion: RoB frequently exists in RCTs recently published in implant dentistry, which may lead to the exaggeration of treatment effects. Better study design, implementation, and reporting are required for clinical trials in implant dentistry to ensure more reliable evidence.

scholarly journals Effectiveness, quality and process evaluation of interventions to prevent childhood obesity.

2020 ◽  
Vol 79 (OCE2) ◽  
Author(s):  
Miguel Seral-Cortes ◽  
Pilar De Miguel-Etayo ◽  
Paola Zapata ◽  
Luis Moreno-Aznar
Keyword(s):  
Childhood Obesity ◽  
Process Evaluation ◽  
Systematic Reviews ◽  
Random Sequence ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Global Public Health ◽  
Program Outcomes ◽  
Sequence Generation ◽  
Random Sequence Generation

AbstractChildhood obesity is one of the most serious global public health challenges of the 21stcentury. Health and scientific organizations demand early interventions, although their complexity generates difficulties in their implementation. In systematic reviews, quality assessments are intended to limit mislead reporting and it is important they are conducted in a manner that minimizes bias. Process evaluation (PE) is used to monitor and document program implementation and can aid in understanding the relationship between specific program elements and program outcomes. Failure to deliver an intervention as intended can lead to unclear conclusions about the effectiveness of the intervention. The aim of the present study is to evaluate the effectiveness of the studies based on the process evaluation and the quality on its interventions. We performed a systematic review of randomized control trials aiming to prevent childhood obesity. The Cochrane Handbook for Systematic Reviews of Interventions tool was used to assess and report methodological risk of bias. Each item was judged as being at high (HR), low (LR) or unclear (UN) risk of bias as per criteria. Key domains random sequence generation and allocation concealment were also assessed. Effectiveness was estimated when the study showed changes in body composition as the main outcome (BMI z-score or waist circumference). Process evaluation was evaluated if at least one process evaluation indicator was identified as being adequately implemented. From the 41 studies, 26 showed any degree of effectiveness and 15 were not effective. Almost half of studies scored high risk of bias: 20/41 (Effective 13/26; non effective 7/15). Moreover, 16/41 studies reported to have unclear risk of bias (effective 10/26; and non-effective 6/15). Only 5/41 articles reported to have low risk (effective 3/26; non effective 2/15). Regarding random sequence generation, there was no difference according to the quality of the studies (effective: LR 25/26, UN 1/26 AND HR 0/26; non effective: LR 15/15, UN 0/15 AND HR 0/15). Concerning the allocation concealment domain, there were no differences found either (effective: LR 11/26, UN 10/26 AND HR 5/26; non effective: LR 7/15, UN 5/15 AND HR 3/15). PE was used in 7 papers (effective 3/7 and non-effective 4/7). Quality seems to have slightly more influence in the non-effective studies (LR 13.3%) than in the effective studies (LR 11.5%). The non-effective studies showed the highest proportion of performing PE. There seems to be a relationship between the quality and PE performance.

scholarly journals The Risk of Bias in Iranian Randomized Controlled Trials Included in Cochrane Reviews

2020 ◽  
Author(s):  
Ali Kabir ◽  
Ahmad Sofi-Mahmudi ◽  
Arman Karimi Behnagh ◽  
Vahid Eidkhani ◽  
Hamid Reza Baradaran ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Random Sequence ◽  
Outcome Data ◽  
Conclusive Evidence ◽  
Risk Of Bias ◽  
Controlled Clinical Trial ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Cochrane Reviews

Abstract Background: Among interventional studies, randomized controlled trials (RCTs) provide the most conclusive evidence. However, RCTs can be susceptible to the risk of bias (RoB). Systematic reviews can be performed to appraise the RoB in the included articles using evaluative tools. This study aimed to describe the main characteristics and focus on the ROB of RCTs conducted in Iran and included in Cochrane Reviews (CRs).Methods: We searched "Iran" by selecting the "Search All Text" and "Review" fields in the Cochrane Database of Systematic Reviews within Ovid. CRs that included the RCTs conducted in Iran were retrieved. A trial was selected only if it was included in CRs, described as a controlled clinical trial, involved human subjects and its RoB was assessed by CR authors. The trials were characterized by investigating the relevant articles and the table "Characteristics of included studies" in each CR. The RoB was investigated by collecting the judgments of the review authors made based on tables of RoB assessment in the CRs.Results: Out of 1166 Iranian RCTs included by 571 CRs, a low RoB was found in 44.9% for random sequence generation, 20.8% for allocation concealment, 32.3% for blinding of participants/personnel, 36.5% for blinding of outcome assessors, 56.3% for incomplete outcome data, 41.3% for selective outcome reporting and 53.8% for other sources of bias.Conclusion: The RoB in Iranian RCTs was found to be mostly high or unclear. It is therefore recommended that the methodological quality of RCTs be seriously addressed in Iran.

scholarly journals Risk of bias assessment of randomised controlled trials referenced in the 2015 American Heart Association guidelines update for cardiopulmonary resuscitation and emergency cardiovascular care: a cross-sectional review

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e023725 ◽  
Author(s):  
Yongil Cho ◽  
Changsun Kim ◽  
Bossng Kang
Keyword(s):  
Random Sequence ◽  
Heart Association ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Cross Sectional ◽  
Sequence Generation ◽  
Random Sequence Generation ◽  
Randomised Controlled ◽  
Cardiovascular Care ◽  
Unclear Risk

ObjectivesTo identify the risk of bias of randomised controlled trials (RCTs) referenced in the 2015 American Heart Association (AHA) guidelines update for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC).DesignA cross-sectional review.SettingAll RCTs cited as references in the 2015 AHA guidelines update for CPR and ECC were extracted. After excluding non-human trials, studies that analysed existing RCTs, and RCTs published in a letter format, two reviewers assessed the risk of bias among RCTs included in this study.Outcome measuresThe Cochrane Collaboration’s tool for assessing the risk of bias in six domains (random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data and selective reporting) was used.ResultsTwo hundred seventy-three RCTs were selected for the analyses. Of these RCTs, 78.8% had a high risk of bias for blinding of participants and personnel, mostly (87.7%) non-drug trials. In drug trials, the proportion of trials with a low risk of bias for blinding of participants and personnel was 73.0%. The proportion of RCTs with an unclear risk of bias were higher for random sequence generation (38.5%) and allocation concealment (34.1%) than in other domains. Unclear risk of bias proportions was 65.4% for random sequence generation and 57.7% for allocation concealment before the introduction of Consolidated Standards of Reporting Trials (CONSORT) but decreased to 31.3% and 32.2% after the 2010 CONSORT update, respectively.ConclusionsThe proportion of RCTs with an unclear risk of bias was still high for random sequence generation and allocation concealment in the 2015 AHA guidelines for CPR and ECC. The risk of bias should be considered when interpreting and applying the CPR guidelines. Authors should plan and report their research using CONSORT guidelines and the Cochrane Collaboration’s tool to reduce the risk of bias.

Association of study design features and treatment effects in trials of chronic medical conditions: a meta-epidemiological study

2021 ◽  
pp. bmjebm-2021-111667
Author(s):  
Zhen Wang ◽  
Fares Alahdab ◽  
Magdoleen Farah ◽  
Mohamed Seisa ◽  
Mohammed Firwana ◽  
...  
Keyword(s):  
Epidemiological Study ◽  
Study Design ◽  
Treatment Effects ◽  
Random Sequence ◽  
Outcome Data ◽  
Allocation Concealment ◽  
Chronic Medical Conditions ◽  
Medical Conditions ◽  
Design Features ◽  
Meta Analyses

ObjectivesTo evaluate the association of study design features and treatment effects in randomised controlled trials (RCTs) evaluating therapies for individuals with chronic medical conditions.DesignMeta-epidemiological study.SettingRCTs from meta-analyses published in the 10 general medical journals with the highest impact factor published between 1 January 2007 and 10 June 2019 and evaluated a drug, procedure or device treatment of chronic medical conditions.Main outcome measuresThe association between trial design features and the effect size, reporting a ratio of ORs (ROR) and 95% confidence interval (CI).ResultsWe included 1098 trials from 86 meta-analyses. The most common outcome in the trials was mortality (52%), followed by disease progression (16%) and adverse events (12%). Lack of blinding of patients and study personnel was associated with a larger treatment effect (ROR 1.12; 95% CI 1.00 to 1.25). There was no statistically significant association with random sequence generation, allocation concealment, blinding of outcome assessors, incomplete outcome data, whether trials were stopped early, study funding, type of interventions or with type of outcomes (objective vs subjective).ConclusionThe meta-epidemiological study did not demonstrate a clear pattern of association between risk of bias indicators and treatment effects in RCTs in chronic medical conditions. The unpredictability of the direction of bias emphasises the need to make every attempt to adhere to blinding, allocation concealment and reduce attrition bias.Trial registration numberNot applicable.

scholarly journals Randomized clinical trial quality has improved over time but is still not good enough: an analysis of 176,620 randomized controlled trials published between 1966 and 2018

2020 ◽  
Author(s):  
Christiaan H. Vinkers ◽  
Herm J. Lamberink ◽  
Joeri K. Tijdink ◽  
Pauline Heus ◽  
Lex Bouter ◽  
...  
Keyword(s):  
Random Sequence ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Trial Registration ◽  
Controlled Trials ◽  
Sequence Generation ◽  
Randomized Controlled ◽  
Random Sequence Generation ◽  
Over Time ◽  
Number Of Authors

AbstractBackgroundMany randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. There is increasing attention for responsible research practices including reporting guidelines, but it is unknown whether these efforts have improved RCT quality (i.e. reduced risk of bias). We therefore mapped trends over time in trial publication, trial registration, reporting according to CONSORT, and characteristics of publication and authors.MethodsMeta-information of 176,620 RCTs published between 1966 and 2018 was extracted. Risk of bias probability (four domains: random sequence generation, allocation concealment, blinding of patients/personnel, and blinding of outcome assessment) was assessed using validated risk-of-bias machine learning tools. In addition, trial registration and reporting according to CONSORT were assessed with automated searches. Characteristics were extracted related to publication (number of authors, journal impact factor, medical discipline) and authors (gender and Hirsch-index).FindingsThe annual number of published RCTs substantially increased over four decades, accompanied by increases in the number of authors (5.2 to 7.8), institutions (2.9 to 4.8), female authors (20 to 42%, first authorship; 17 to 29%, last authorship), and Hirsch-indices (10 to 14, first authorship; 16 to 28, last authorship). Risk of bias remained present in most RCTs but decreased over time for the domains allocation concealment (63 to 51%), random sequence generation (57 to 36%), and blinding of outcome assessment (58 to 52%). Trial registration (37 to 47%) and CONSORT (1 to 20%) rapidly increased in the latest period. In journals with higher impact factor (>10), risk of bias was consistently lower, higher levels of trial registration more frequent, and mentioning CONSORT.InterpretationThe likelihood of bias in RCTs has generally decreased over the last decades. This may be driven by increased knowledge and improved education, augmented by mandatory trial registration, and more stringent reporting guidelines and journal requirements. Nevertheless, relatively high probabilities of bias remain, particularly in journals with lower impact factors. This emphasizes that further improvement of RCT registration, conduct, and reporting is still urgently needed.FundingThis study was funded by The Netherlands Organisation for Health Research and Development (445001002).

scholarly journals The methodological quality of 176,620 randomized controlled trials published between 1966 and 2018 reveals a positive trend but also an urgent need for improvement

PLoS Biology ◽  
2021 ◽  
Vol 19 (4) ◽  
pp. e3001162
Author(s):  
Christiaan H. Vinkers ◽  
Herm J. Lamberink ◽  
Joeri K. Tijdink ◽  
Pauline Heus ◽  
Lex Bouter ◽  
...  
Keyword(s):  
Outcome Assessment ◽  
Random Sequence ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Sequence Generation ◽  
Randomized Controlled ◽  
The Consort Statement ◽  
Random Sequence Generation

Many randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. There is increasing attention for responsible research practices and implementation of reporting guidelines, but whether these efforts have improved the methodological quality of RCTs (e.g., lower risk of bias) is unknown. We, therefore, mapped risk-of-bias trends over time in RCT publications in relation to journal and author characteristics. Meta-information of 176,620 RCTs published between 1966 and 2018 was extracted. The risk-of-bias probability (random sequence generation, allocation concealment, blinding of patients/personnel, and blinding of outcome assessment) was assessed using a risk-of-bias machine learning tool. This tool was simultaneously validated using 63,327 human risk-of-bias assessments obtained from 17,394 RCTs evaluated in the Cochrane Database of Systematic Reviews (CDSR). Moreover, RCT registration and CONSORT Statement reporting were assessed using automated searches. Publication characteristics included the number of authors, journal impact factor (JIF), and medical discipline. The annual number of published RCTs substantially increased over 4 decades, accompanied by increases in authors (5.2 to 7.8) and institutions (2.9 to 4.8). The risk of bias remained present in most RCTs but decreased over time for allocation concealment (63% to 51%), random sequence generation (57% to 36%), and blinding of outcome assessment (58% to 52%). Trial registration (37% to 47%) and the use of the CONSORT Statement (1% to 20%) also rapidly increased. In journals with a higher impact factor (>10), the risk of bias was consistently lower with higher levels of RCT registration and the use of the CONSORT Statement. Automated risk-of-bias predictions had accuracies above 70% for allocation concealment (70.7%), random sequence generation (72.1%), and blinding of patients/personnel (79.8%), but not for blinding of outcome assessment (62.7%). In conclusion, the likelihood of bias in RCTs has generally decreased over the last decades. This optimistic trend may be driven by increased knowledge augmented by mandatory trial registration and more stringent reporting guidelines and journal requirements. Nevertheless, relatively high probabilities of bias remain, particularly in journals with lower impact factors. This emphasizes that further improvement of RCT registration, conduct, and reporting is still urgently needed.

scholarly journals Effectiveness of Nutritional Education for Obese Older Adults With Frailty: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 401-401
Author(s):  
Yue-Heng Yin ◽  
Liu Yat Justina
Keyword(s):  
Systematic Review ◽  
Physical Function ◽  
Meta Analysis ◽  
Experimental Studies ◽  
Well Being ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Nutritional Education ◽  
Hand Search ◽  
Education Interventions

Abstract Obesity has been shown to intensify the decline of physical function and lead to frailty. Nutrition is an important method in managing obesity and frailty, while seldom reviews have ever explored the effects of nutritional education interventions. We conducted a systematic review (PROSPERO: CRD42019142403) to explore the effectiveness of nutritional education interventions in managing body composition and physio-psychosocial parameters related to frailty. Randomized controlled trials and quasi-experimental studies were searched in CINAHL, Cochrane Library, EMBASE, MEDLINE, PsycINFO, PubMed and Scopus from 2001 to 2019. Hand search for the reference lists of included papers was conducted as well. We assessed the quality of included studies by Cochrane risk of bias tool. Meta-analyses and narrative synthesis were used to analyse the data. Two studies with low risk of bias were screened from 180 articles, which involved 177 older people with an average age of 69.69±4.08 years old. The results showed that nutritional education was significantly effective in reducing body weight and fat mass than exercises, and it was beneficial to enhancing physical function and psychosocial well-being. But the effects of nutritional education in increasing muscle strength were not better than exercises. The combined effects of nutritional education and exercises were superior than either exercises or nutritional education interventions solely in preventing the loss of lean mass and bone marrow density, and in improving physical function. Due to limited numbers of relevant studies, the strong evidence of effectiveness of nutritional education interventions on reversing frailty is still lacking.

scholarly journals Self-Leadership and Psychological Capital as Key Cognitive Resources for Shaping Health-Protective Behaviors during the COVID-19 Pandemic

2021 ◽  
Vol 11 (2) ◽  
pp. 41
Author(s):  
Sherry A. Maykrantz ◽  
Luke A. Langlinais ◽  
Jeffery D. Houghton ◽  
Christopher P. Neck
Keyword(s):  
Self Efficacy ◽  
Cognitive Theory ◽  
Psychological Capital ◽  
Health Belief ◽  
Well Being ◽  
Cognitive Resources ◽  
Psychological Resources ◽  
Protective Behaviors ◽  
Theoretical Frameworks ◽  
And Coping

As COVID-19 has become a global pandemic, health researchers and practitioners have focused attention on identifying the factors that may help to shape health-protective behaviors, protecting individual health and well-being, and helping to mitigate the spread of COVID-19. This study explores the potential role of self-leadership and psychological capital (PsyCap) as key cognitive resources for shaping health-protective behaviors. Using multiple theoretical frameworks (social cognitive theory, psychological resources theory, and the health belief model), this paper develops and tests a hypothesized serial mediation model in which PsyCap and coping self-efficacy mediate the relationship between self-leadership and health-protective behaviors including hand washing, wearing face masks, and social distancing. Results suggest that PsyCap and coping self-efficacy mediate the positive relationship between self-leadership and health-protective behaviors. These results yield valuable insights regarding the usefulness of self-leadership and PsyCap as cognitive resources for shaping health-protective behaviors and for possible self-leadership and PsyCap interventions, potentially tailored to at-risk populations, which should have practical benefits for both the current and future pandemics and health crises.

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