Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review

Background. Patient comprehension is fundamental to valid informed consent. Current practices often result in inadequate patient comprehension. Purpose. An updated review to evaluate the characteristics and outcomes of interventions to improve patient comprehension in clinical informed consent. Data Sources. Systematic searches of MEDLINE and EMBASE (2008–2018). Study Selection. We included randomized and nonrandomized controlled trials evaluating interventions to improve patient comprehension in clinical informed consent. Data Extraction. Reviewers independently abstracted data using a standardized form, comparing all results and resolving disagreements by consensus. Data Synthesis. Fifty-two studies of 60 interventions met inclusion criteria. Compared with standard informed consent, a statistically significant improvement in patient comprehension was seen with 43% (6/14) of written interventions, 56% (15/27) of audiovisual interventions, 67% (2/3) of multicomponent interventions, 85% (11/13) of interactive digital interventions, and 100% (3/3) of verbal discussion with test/feedback or teach-back interventions. Eighty-five percent of studies (44/52) evaluated patients’ understanding of risks, 69% (41/52) general knowledge about the procedure, 35% (18/52) understanding of benefits, and 31% (16/52) understanding of alternatives. Participants’ education level was reported heterogeneously, and only 8% (4/52) of studies examined effects according to health literacy. Most studies (79%, 41/52) did not specify participants’ race/ethnicity. Limitations. Variation in interventions and outcome measures precluded conduct of a meta-analysis or calculation of mean effect size. Control group processes were variable and inconsistently characterized. Nearly half of studies (44%, 23/52) had a high risk of bias for the patient comprehension outcome. Conclusions. Interventions to improve patient comprehension in informed consent are heterogeneous. Interactive interventions, particularly with test/feedback or teach-back components, appear superior. Future research should emphasize all key elements of informed consent and explore effects among vulnerable populations.

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A Systematic Review and Meta-Analysis about the Effect of Bisphosphonates on the Risk of Skeletal-Related Event in Men with Prostate Cancer

Anti-Cancer Agents in Medicinal Chemistry ◽

10.2174/1871520620666200521114815 ◽

2020 ◽

Vol 20 (13) ◽

pp. 1604-1612

Author(s):

Congcong Wu ◽

Hua Jiang ◽

Jianghua Chen

Keyword(s):

Prostate Cancer ◽

Fixed Effects ◽

Data Extraction ◽

Controlled Trial ◽

Meta Analysis ◽

Control Group ◽

Fixed Effects Model ◽

Related Event ◽

Mineral Density ◽

Skeletal Related Event

Background: Although the adjuvant therapy of bisphosphonates in prostate cancer is effective in improving bone mineral density, it is still uncertain whether bisphosphonates could decrease the risk of Skeletal- Related Event (SRE) in patients with prostate cancer. We reviewed and analyzed the effect of different types of bisphosphonates on the risk of SRE, defined as pathological fracture, spinal cord compression, radiation therapy to the bone, surgery to bone, hypercalcemia, bone pain, or death as a result of prostate cancer. Methods: A systemic literature search was conducted on PubMed and related bibliographies. The emphasis during data extraction was laid on the Hazard Ratio (HR) and the corresponding 95% Confidence Interval (CI) from every eligible Randomized Controlled Trial (RCT). HR was pooled with the fixed effects model, and preplanned subgroup analyses were performed. Results: 5 RCTs (n = 4651) were included and analyzed finally after screening 51 articles. The meta-analysis of all participants showed no significant decrease in the risk of SRE when adding bisphosphonates to control group (HR = 0.968, 95% CI = 0.874 - 1.072, p = 0.536) with low heterogeneity (I2 = 0.0% (d.f. = 4) p = 0.679). There was no significant improvement on SRE neither in the subgroups with Metastases (M1) or Castration-Sensitive Prostate Cancer (CSPC) (respectively HR = 0.968, 95% CI = 0.874 - 1.072, p = 0.536, I2 = 0.0% (d.f. = 4) p = 0.679; HR = 0.954, 95% CI = 0.837 - 1.088, p = 0.484, I2 = 0.0% (d.f. = 3) p = 0.534). Conclusion: Our study demonstrated that bisphosphonates could not statistically significantly reduce the risk of SRE in patients with prostate cancer, neither in the subgroups with M1 or CSPC.

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The Effectiveness of School-Based Interventions on Obesity-Related Behaviours in Primary School Children: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

Children ◽

10.3390/children8060489 ◽

2021 ◽

Vol 8 (6) ◽

pp. 489

Author(s):

Sarah Nally ◽

Angela Carlin ◽

Nicole E. Blackburn ◽

Judith S. Baird ◽

Jo Salmon ◽

...

Keyword(s):

Sedentary Behaviour ◽

Vegetable Intake ◽

Data Extraction ◽

Meta Analysis ◽

Primary School Children ◽

Control Group ◽

Z Score ◽

School Based ◽

Positive Treatment ◽

School Based Interventions

School-based interventions are promising for targeting a change in obesity-related behaviours in children. However, the efficacy of school-based interventions to prevent obesity remains unclear. This review examined the effectiveness of school-based interventions at changing obesity-related behaviours (increased physical activity, decreased sedentary behaviour and improved nutrition behaviour) and/or a change in BMI/BMI z-score. Following PRISMA guidelines, seven databases were systematically searched from 1 January 2009 to 31 December 2020. Two review authors independently screened studies for eligibility, completed data extraction and assessed the risk of bias of each of the included studies. Forty-eight studies met the inclusion criteria and were included in a narrative synthesis. Thirty-eight studies were eligible for inclusion in a meta-analysis. The findings demonstrate that interventions in children when compared to controls resulted in a small positive treatment effect in the control group (2.14; 95% CI = 0.77, 3.50). There was no significant effect on sedentary behaviour, energy intake and fruit and vegetable intake. Significant reductions were found between groups in BMI kg/m2 (−0.39; 95% CI = −0.47, −0.30) and BMI z-score (−0.05; 95% CI = −0.08, −0.02) in favour of the intervention. The findings have important implications for future intervention research in terms of the effectiveness of intervention components and characteristics.

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Third-wave interventions for eating disorders in adolescence – systematic review with meta-analysis

Borderline Personality Disorder and Emotion Dysregulation ◽

10.1186/s40479-021-00158-6 ◽

2021 ◽

Vol 8 (1) ◽

Author(s):

Arne Buerger ◽

Timo D. Vloet ◽

Lisa Haber ◽

Julia M. Geissler

Keyword(s):

Eating Disorder ◽

Data Extraction ◽

Meta Analysis ◽

Structured Interview ◽

Control Group ◽

Third Wave ◽

Eating Disorder Inventory ◽

Behaviour Therapy ◽

Qualitative Synthesis ◽

Eating Disorder Examination

Abstract Context Third-wave therapies have demonstrated efficacy as a treatment option for EDs in adulthood. Data on the suitability for EDs in adolescence are lacking. Objective To estimate the efficacy of third-wave interventions to reduce ED symptoms in adolescents in randomized controlled trials (RCTs) and uncontrolled studies. Data sources We systematically reviewed the databases PubMed (1976-January 2021), PsycINFO (1943-January 2021), and the Cochrane database (1995-January 2021) for English-language articles on third-wave therapies. References were screened for further publications of interest. Study selection RCTs and pre-post studies without control group, comprising patients aged 11–21 years (mean age = 15.6 years) with an ED diagnosis (anorexia nervosa, bulimia nervosa, binge eating disorder, eating disorder not otherwise specified) investigating the efficacy of third-wave psychological interventions were included. Efficacy had to be evaluated according to the Eating Disorder Examination or Eating Disorder Examination-Questionnaire, the Eating Disorder Inventory-2, the Eating Disorder Inventory-3, or the Structured Interview for Anorexic and Bulimic Disorders for DSM-IV and ICD-10. The outcome assessed in the meta-analysis was the EDE total score. Data extraction Independent extraction of data by two authors according to a pre-specified data extraction sheet and quality indicators. Data synthesis We identified 1000 studies after removal of duplicates, assessed the full texts of 48 articles for eligibility, and included 12 studies with a total of 487 participants (female 97.3%/male 2.6%) in the qualitative synthesis and seven studies in the meta-analysis. Articles predominantly reported uncontrolled pre-post trials of low quality, with only two published RCTs. Treatments focused strongly on dialectical behaviour therapy (n = 11). We found moderate effects of third-wave therapies on EDE total score interview/questionnaire for all EDs (d = − 0.67; z = − 5.53; CI95% = − 0.83 to − 0.59). Descriptively, the effects appeared to be stronger in patients with BN and BED. Conclusion At this stage, it is not feasible to draw conclusions regarding the efficacy of third-wave interventions for the treatment of EDs in adolescence due to the low quality of the empirical evidence. Since almost all of the identified studies used DBT, it is unfortunately not possible to assess other third-wave treatments’ efficacy.

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Effect of Acupuncture on Heart Rate Variability: A Systematic Review

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2014/819871 ◽

2014 ◽

Vol 2014 ◽

pp. 1-19 ◽

Cited By ~ 22

Author(s):

Joanne W. Y. Chung ◽

Vincent C. M. Yan ◽

Hongwei Zhang

Keyword(s):

Systematic Review ◽

Heart Rate ◽

Heart Rate Variability ◽

High Frequency ◽

Healthy Subjects ◽

Keyword Search ◽

Data Extraction ◽

Meta Analysis ◽

Low Frequency ◽

Control Group

Aim.To summarize all relevant trials and critically evaluate the effect of acupuncture on heart rate variability (HRV).Method.This was a systematic review with meta-analysis. Keyword search was conducted in 7 databases for randomized controlled trials (RCTs). Data extraction and risk of bias were done.Results.Fourteen included studies showed a decreasing effect of acupuncture on low frequency (LF) and low frequency to high frequency ratio (LF/HF ratio) of HRV for nonhealthy subjects and on normalized low frequency (LF norm) for healthy subjects. The overall effect was in favour of the sham/control group for high frequency (HF) in nonhealthy subjects and for normalized high frequency (HF norm) in healthy subjects. Significant decreasing effect on HF and LF/HF ratio of HRV when acupuncture was performed on ST36 among healthy subjects and PC6 among both healthy and nonhealthy subjects, respectively.Discussion.This study partially supports the possible effect of acupuncture in modulating the LF of HRV in both healthy and nonhealthy subjects, while previous review reported that acupuncture did not have any convincing effect on HRV in healthy subjects. More published work is needed in this area to determine if HRV can be an indicator of the therapeutic effect of acupuncture.

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Use of Meta-Analysis to Uncover the Critical Issues of Mobile Inquiry-Based Learning

Journal of Educational Computing Research ◽

10.1177/0735633119879366 ◽

2019 ◽

Vol 58 (4) ◽

pp. 715-746

Author(s):

Je-Ming Yang ◽

Yao-Ting Sung ◽

Kuo-En Chang

Keyword(s):

Learning Outcomes ◽

Mobile Devices ◽

Teaching Methods ◽

Meta Analysis ◽

Learning Activities ◽

Future Research ◽

Control Group ◽

Journal Articles ◽

Inquiry Based Learning ◽

Critical Issues

Using mobile devices to support the process and products of learning activities is a trend in inquiry-based learning, which is culminating in the formation of the subfield of mobile inquiry-based learning (m-IBL). However, even though mobile devices have been widely used in IBL activities in recent years, evaluative evidence for their substantial contributions to IBL is still deficient. Therefore, this study collected and analyzed 40 peer-reviewed journal articles published during 2001 to 2017 involving 3,542 participants and further discovered that m-IBL has produced meaningful improvements for IBL with an overall mean effect size of 0.803, with a 95% confidence interval [0.61, 0.99]. In addition, moderator variables such as control group types, learning outcomes, inquiry types, teaching methods, and domain subjects were related to different effect sizes. Finally, the results of the meta-analysis were discussed along with their implications for future research and practice.

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Academic Achievement and Peer Tutoring in Mathematics: A Comparison Between Primary and Secondary Education

SAGE Open ◽

10.1177/2158244020929295 ◽

2020 ◽

Vol 10 (2) ◽

pp. 215824402092929 ◽

Cited By ~ 2

Author(s):

Francisco Alegre ◽

Lidón Moliner ◽

Ana Maroto ◽

Gil Lorenzo-Valentin

Keyword(s):

Secondary Education ◽

Elementary Education ◽

Peer Tutoring ◽

Meta Analysis ◽

Future Research ◽

Control Group ◽

Educational Levels ◽

Primary And Secondary Education ◽

Academic Benefits ◽

Quasi Experimental

Peer tutoring in Mathematics has reported academic benefits across many educational levels, from Preschool to Higher Education. However, recent literature reviews and meta-analysis state that students experience higher gains in Primary or Elementary Education (ages 7–12 years) than in secondary education or middle school and high school (ages 13–18 years). This study examined the effects of peer tutoring on students’ mathematics achievement in primary and secondary education under similar settings. 89 students from first, fourth, seventh, and ninth grades participated in the study. The design of this research was quasi-experimental with pretest–posttest without control group. The statistical analysis reported significant improvements for both, Primary and Secondary Education. The comparison between these educational levels showed that there were no significant differences in the increments of the students’ marks. The global effect size reported for the experience was Cohen’s d = 0.78. The main conclusion is that Peer Tutoring in Mathematics reports similar academic benefits for both, Primary and Secondary Education. Future research must be conducted as the superiority of Peer Tutoring in Primary over Secondary Education has yet to be proved in the Mathematics subject.

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Therapeutic efficacy of specific immunotherapy for glioma: a systematic review and meta-analysis

Reviews in the Neurosciences ◽

10.1515/revneuro-2017-0057 ◽

2018 ◽

Vol 29 (4) ◽

pp. 443-461 ◽

Cited By ~ 5

Author(s):

Sara Hanaei ◽

Khashayar Afshari ◽

Armin Hirbod-Mobarakeh ◽

Bahram Mohajer ◽

Delara Amir Dastmalchi ◽

...

Keyword(s):

Systematic Review ◽

Overall Survival ◽

Clinical Trials ◽

Specific Immunotherapy ◽

Data Extraction ◽

Meta Analysis ◽

Progression Free Survival ◽

Control Group ◽

Free Survival ◽

Median Difference

Abstract Although different immunotherapeutic approaches have been developed for the treatment of glioma, there is a discrepancy between clinical trials limiting their approval as common treatment. So, the current systematic review and meta-analysis were conducted to assess survival and clinical response of specific immunotherapy in patients with glioma. Generally, seven databases were searched to find eligible studies. Controlled clinical trials investigating the efficacy of specific immunotherapy in glioma were found eligible. After data extraction and risk of bias assessment, the data were analyzed based on the level of heterogeneity. Overall, 25 articles with 2964 patients were included. Generally, mean overall survival did not statistically improve in immunotherapy [median difference=1.51; 95% confidence interval (CI)=−0.16–3.17; p=0.08]; however, it was 11.16 months higher in passive immunotherapy (95% CI=5.69–16.64; p<0.0001). One-year overall survival was significantly higher in immunotherapy groups [hazard ratio (HR)=0.69; 95% CI=0.52–0.92; p=0.01]. As the hazard rate in the immunotherapy approach was 0.83 of the control group, 2-year overall survival was significantly higher in immunotherapy (HR=0.83; 95% CI=0.69–0.99; p=0.04). Three-year overall survival was significantly higher in immunotherapy as well (HR=0.67; 95% CI=0.48–0.92; p=0.01). Overall, median progression-free survival was significantly higher in immunotherapy (standard median difference=0.323; 95% CI=0.110–0.536; p=0.003). However, 1-year progression-free survival was not remarkably different between immunotherapy and control groups (HR=0.94; 95% CI=0.74–1.18; p=0.59). Specific immunotherapy demonstrated remarkable improvement in survival of patients with glioma and could be a considerable choice of treatment in the future. Despite the current promising results, further high-quality randomized controlled trials are required to approve immunotherapeutic approaches as the standard of care and the front-line treatment for glioma.

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Chinese Herbal Medicine Banxiaxiexin Decoction Treating Diabetic Gastroparesis: A Systematic Review of Randomized Controlled Trials

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/749495 ◽

2013 ◽

Vol 2013 ◽

pp. 1-11 ◽

Cited By ~ 5

Author(s):

Jiaxing Tian ◽

Min Li ◽

Jiangquan Liao ◽

Junling Li ◽

Xiaolin Tong

Keyword(s):

Methodological Quality ◽

Large Scale ◽

Data Extraction ◽

Cochrane Review ◽

Gastrointestinal Symptoms ◽

Diabetic Gastroparesis ◽

Future Research ◽

Control Group ◽

Gastric Emptying Rate ◽

Randomized Controlled

Objective. To assess the current clinical evidence of Banxiaxiexin decoction for diabetic gastroparesis (DGP).Methods. Electronic databases were searched until December 2012. No language limitations were applied. We included RCTs using Banxiaxiexin decoction/modified Banxiaxiexin decoction for DGP. No restriction for the control group except acupuncture. Applying clinical effective rate as the main outcome index. Data extraction, analyses and quality assessment were conducted according to the Cochrane review standards.Results. 16 RCTs involving 1302 patients were finally identified, and the methodological quality was evaluated as generally low. The data showed that the effect of Banxiaxiexin decoction (BXXD) for DGP was superior to the control group (n=1302, RR 1.23, 95% CI 1.17 to 1.29,Z=8.04,P<0.00001). Only one trial recorded adverse events, no obvious adverse event occurred.Conclusions. Banxiaxiexin decoction could regain the gastric emptying rate and improve diabetic gastrointestinal symptoms. However, the methodological quality of included studies is low, and long term efficacy and safety are still uncertain, which indicates that the findings above should be read with caution. Thereby, well-designed, large-scale, and high-quality randomized controlled clinical trials with scientific rigor are warranted for stronger evidence in future research.

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Moxibustion for Chronic Fatigue Syndrome: A Systematic Review and Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/6418217 ◽

2021 ◽

Vol 2021 ◽

pp. 1-11

Author(s):

Jianyu You ◽

Jing Ye ◽

Haiyan Li ◽

Wenguo Ye ◽

Ensi Hong

Keyword(s):

Chronic Fatigue Syndrome ◽

Data Extraction ◽

Meta Analysis ◽

Complementary Therapy ◽

Chronic Fatigue ◽

Assessment Instrument ◽

Favorable Effect ◽

Control Group ◽

Level Of Evidence ◽

Fatigue Syndrome

Objective. This review aimed at systematically evaluating the efficacy and safety of moxibustion for chronic fatigue syndrome (CFS). Methods. Relevant trials were searched in seven digital databases up to January 2021. After literature screening, data extraction, and literature quality evaluation, the included studies were meta-analyzed using RevMan 5.4 software. The evidence level was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE). Results. Fifteen studies involving 1030 CFS participants were included. Meta-analyses showed a favorable effect of moxibustion on the total effective rate compared with acupuncture (OR = 4.58, 95%CI = [2.85, 7.35], P < 0.00001 ) and drugs (OR = 6.36, 95%CI = [3.48, 11.59], P < 0.00001 ). Moxibustion also appeared to significantly reduce fatigue severity measured by fatigue scale-14 (FS-14) (WMD = −2.20, 95% CI = [−3.16, −1.24], P < 0.00001 ) and fatigue assessment instrument (FAI) (WMD = −16.36, 95% CI = [−26.58, −6.14], P = 0.002 ) compared with the control group. In addition, among the 15 included studies, only two studies reported adverse events related to moxibustion, and the symptoms were relatively mild. The quality of evidence based on the 15 included trials was assessed as moderate to very low. Conclusions. Based on limited evidence, moxibustion might be an effective and safe complementary therapy for CFS, which can be recommended to manage CFS. Because of the limited level of evidence in this review, further high-quality trials are still needed to confirm these findings.

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Effects of Aerobic Training Progression on Blood Pressure in Individuals With Hypertension: A Systematic Review With Meta-Analysis and Meta-Regression

10.21203/rs.3.rs-156120/v1 ◽

2021 ◽

Author(s):

Guilherme Tadeu de Barcelos¹ ◽

Isabel Heberle¹ ◽

Juliana Cavestré Coneglian¹ ◽

Bruno Allan Vieira¹ ◽

Rodrigo Sudatti Delevatti¹ ◽

...

Keyword(s):

Systematic Review ◽

Blood Pressure ◽

Clinical Trials ◽

Systolic Blood Pressure ◽

Aerobic Training ◽

Data Extraction ◽

Meta Analysis ◽

Control Group ◽

Meta Regression ◽

Selection Of

Abstract Objective: To analyze, through a systematic review with meta-analysis, the effects of aerobic training with and without progression on systolic blood pressure (SBP) and diastolic blood pressure (DBP) in hypertensive adults.Method: The search for the studies was carried out in the PubMed, Cochrane Central, SPORTDiscus and LILACS databases. Clinical trials that analyzed the effect of aerobic training, lasting at least six weeks, on blood pressure in hypertensive individuals comparing with a control group without intervention were selected. The selection of studies and data extraction were carried out independently by two pairs of researchers. Results: Of the 13028 studies found, 24 were selected and included in this review. There was a reduction in SBP after aerobic training with progression (-10.67 mmHg; 95% CI -15.421, -5.926; p <0.001) and without progression (-10.17 mmHg; CI -12.213, -8.120; p <0.001). DBP also decreased after aerobic training with progression (-5.49 mmHg; 95% CI -8.663, -2.310; p <0.001) and without progression (-6.51 mmHg; 95% CI -9.147, -3.868; p < 0.001). Conclusion: Aerobic training promotes a reduction in the SBP and DBP levels of adults with hypertension, regardless of whether or not the training variables progression.

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