scholarly journals Does evidence support the high expectations placed in precision medicine? A bibliographic review

F1000Research ◽  
2019 ◽  
Vol 7 ◽  
pp. 30 ◽  
Author(s):  
Jordi Cortés ◽  
José Antonio González ◽  
María Nuncia Medina ◽  
Markus Vogler ◽  
Marta Vilaró ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Intervention Group ◽  
Individual Characteristics ◽  
Point Estimate ◽  
Control Group ◽  
Variance Ratio ◽  
Economic Costs ◽  
High Expectations ◽  
The Mean ◽  
And Control

Background: Precision medicine is the Holy Grail of interventions that are tailored to a patient’s individual characteristics. However, conventional clinical trials are designed to find differences in averages, and interpreting these differences depends on untestable assumptions. Although ideal, a constant effect would facilitate individual management. Another consequence of a constant effect is that the outcome variance would be the same in treated and control arms. We reviewed the literature to explore the similarity of these variances as a foundation for examining whether and how often precision medicine is definitively needed. Methods: We reviewed parallel trials with quantitative outcomes published in 2004, 2007, 2010 and 2013. We collected baseline and final standard deviations of the main outcome. We assessed homoscedasticity by comparing the variance of the primary endpoint between arms through the outcome variance ratio (treated to control group). Results: The review provided 208 articles with enough information to conduct the analysis. One out of seven studies (n = 30, 14.4%) had statistically different variances between groups, leading a non-constant-effect. The adjusted point estimate of the mean outcome variance ratio (treated to control group) is 0.89 (95% CI 0.81 to 0.97). Conclusions: We found that the outcome variance was more often smaller in the intervention group, suggesting that treated patients may end up pertaining more often to reference values. This observed reduction in variance might also imply that there could be a subgroup of less ill patients who derive no benefit, which would require studying whether the effect merits enduring the side effects as well as the economic costs. We have shown that the comparison of variances is a useful but not definitive tool for assessing whether or not the assumption of a constant effect holds.

scholarly journals Does evidence support the high expectations placed in precision medicine? A bibliographic review

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 30 ◽  
Author(s):  
Jordi Cortés ◽  
José Antonio González ◽  
María Nuncia Medina ◽  
Markus Vogler ◽  
Marta Vilaró ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Randomized Trials ◽  
Intervention Group ◽  
Individual Characteristics ◽  
Point Estimate ◽  
Control Group ◽  
Eligibility Criteria ◽  
High Expectations ◽  
The Mean ◽  
And Control

Background: Precision medicine is the Holy Grail of interventions that are tailored to a patient’s individual characteristics. However, the conventional design of randomized trials assumes that each individual benefits by the same amount. Methods: We reviewed parallel trials with quantitative outcomes published in 2004, 2007, 2010 and 2013. We collected baseline and final standard deviations of the main outcome. We assessed homoscedasticity by comparing the outcome variability between treated and control arms. Results: The review provided 208 articles with enough information to conduct the analysis. At the end of the study, 113 (54%, 95% CI 47 to 61%) papers find less variability in the treated arm. The adjusted point estimate of the mean ratio (treated to control group) of the outcome variances is 0.89 (95% CI 0.81 to 0.97). Conclusions: Some variance inflation was observed in just 1 out of 6 interventions, suggesting the need for further eligibility criteria to tailor precision medicine. Surprisingly, the variance was more often smaller in the intervention group, suggesting, if anything, a reduced role for precision medicine.  Homoscedasticity is a useful tool for assessing whether or not the premise of constant effect is reasonable.

scholarly journals Does evidence support the high expectations placed in precision medicine? A bibliographic review

F1000Research ◽  
2019 ◽  
Vol 7 ◽  
pp. 30 ◽  
Author(s):  
Jordi Cortés ◽  
José Antonio González ◽  
María Nuncia Medina ◽  
Markus Vogler ◽  
Marta Vilaró ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Precision Medicine ◽  
Outcome Measure ◽  
Intervention Group ◽  
Direct Consequence ◽  
Individual Characteristics ◽  
Point Estimate ◽  
Control Group ◽  
Variance Ratio ◽  
The Mean

Background: Precision medicine is the Holy Grail of interventions that are tailored to a patient’s individual characteristics. However, conventional clinical trials are designed to find differences in averages, and interpreting these differences depends on untestable assumptions. Although only an ideal, a constant effect of treatment would facilitate individual management. A direct consequence of a constant effect is that the variance of the outcome measure would be the same in the treated and control arms. We reviewed the literature to explore the similarity of these variances as a foundation for examining whether and how often precision medicine is definitively required. Methods: We reviewed parallel clinical trials with numerical primary endpoints published in 2004, 2007, 2010 and 2013. We collected the baseline and final standard deviations of the main outcome measure. We assessed homoscedasticity by comparing the variance of the primary endpoint between arms through the outcome variance ratio (treated to control group). Results: The review provided 208 articles with enough information to conduct the analysis. One out of five studies (n = 40, 19.2%) had statistically different variances between groups, implying a non-constant-effect. The adjusted point estimate of the mean outcome variance ratio (treated to control group) is 0.89 (95% CI 0.81 to 0.97). Conclusions: The mean variance ratio is significantly lower than 1 and the lower variance was found more often in the intervention group than in the control group, suggesting it is more usual for treated patients to be stable. This observed reduction in variance might also imply that there could be a subgroup of less ill patients who derive no benefit from treatment. This would require further study as to whether the treatment effect outweighs the side effects as well as the economic costs. We have shown that there are ways to analyze the apparently unobservable constant effect.

scholarly journals Does evidence support the high expectations placed in precision medicine? A bibliographic review

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 30 ◽  
Author(s):  
Jordi Cortés ◽  
José Antonio González ◽  
María Nuncia Medina ◽  
Markus Vogler ◽  
Marta Vilaró ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Intervention Group ◽  
Individual Characteristics ◽  
Outcome Variable ◽  
Point Estimate ◽  
Control Group ◽  
Implicit Assumption ◽  
Variance Ratio ◽  
Eligibility Criteria ◽  
High Expectations

Background: Precision medicine is the Holy Grail of interventions that are tailored to a patient’s individual characteristics. However, conventional clinical trials are designed to find differences with the implicit assumption that the effect is the same in all patients within the eligibility criteria. If this were the case, then there would be no grounds for treating different patients differently. One consequence of the assumption is that the variance in the outcome variable would be the same in treated and control arms. We reviewed the literature to see if this were the case and so to see how often precision medicine would not be useful. Methods: We reviewed parallel trials with quantitative outcomes published in 2004, 2007, 2010 and 2013. We collected baseline and final standard deviations of the main outcome. We assessed homoscedasticity by comparing the variance of the primary endpoint between arms through the outcome variance ratio (treated to control group). Results: The review provided 208 articles with enough information to conduct the analysis. One out of seven studies (n = 30, 14.4%) had statistically different variances between groups, leading a non-constant-effect. The adjusted point estimate of the mean outcome variance ratio (treated to control group) is 0.89 (95% CI 0.81 to 0.97). Conclusions: We found that the outcome variance was more often smaller in the intervention group, suggesting that treated patients may end up pertaining more often to reference or “normality” values and thus would not require further precision medicine. However, this result may also be compatible with a reduced effect in some patients, which would require studying whether the effect merits enduring the side effects as well as the economic costs. We have shown that the comparison of variances is a useful but not definitive tool to asses if the design assumption of a constant effect holds.

scholarly journals Does evidence support the high expectations placed in precision medicine? A bibliographic review

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 30 ◽  
Author(s):  
Jordi Cortés ◽  
José Antonio González ◽  
María Nuncia Medina ◽  
Markus Vogler ◽  
Marta Vilaró ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Intervention Group ◽  
Individual Characteristics ◽  
Outcome Variable ◽  
Point Estimate ◽  
Control Group ◽  
Implicit Assumption ◽  
Variance Ratio ◽  
Eligibility Criteria ◽  
High Expectations

Background: Precision medicine is the Holy Grail of interventions that are tailored to a patient’s individual characteristics. However, conventional clinical trials are designed to find differences with the implicit assumption that the effect is the same in all patients within the eligibility criteria. If this were the case, then there would be no grounds for treating different patients differently. One consequence of the assumption is that the variance in the outcome variable would be the same in treated and control arms. We reviewed the literature to see if this were the case and so to see how often precision medicine would not be useful. Methods: We reviewed parallel trials with quantitative outcomes published in 2004, 2007, 2010 and 2013. We collected baseline and final standard deviations of the main outcome. We assessed homoscedasticity by comparing the variance of the primary endpoint between arms through the outcome variance ratio (treated to control group). Results: The review provided 208 articles with enough information to conduct the analysis. One out of seven studies (n = 30, 14.4%) had statistically different variances between groups, leading a non-constant-effect. The adjusted point estimate of the mean outcome variance ratio (treated to control group) is 0.89 (95% CI 0.81 to 0.97). Conclusions: We found that the outcome variance was more often smaller in the intervention group, suggesting that treated patients may end up pertaining more often to reference or “normality” values and thus would not require further precision medicine. However, this result may also be compatible with a reduced effect in some patients, which would require studying whether the effect merits enduring the side effects as well as the economic costs. We have shown that the comparison of variances is a useful but not definitive tool to asses if the design assumption of a constant effect holds.

The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Asieh Mehdipour ◽  
Parvin Abedi ◽  
Somayeh Ansari ◽  
Maryam Dastoorpoor
Keyword(s):  
Randomized Controlled Trial ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Moderate Depression ◽  
Before And After ◽  
The Mean ◽  
And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

scholarly journals Effect of Hope-oriented group counseling on mental health of infertile women with failed IVF cycles: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Roya Rahimi ◽  
Shirin Hasanpour ◽  
Mojgan. Mirghafourvand ◽  
Khalil Esmaeilpour
Keyword(s):  
Mental Health ◽  
Confidence Interval ◽  
Group Counseling ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
The Mean ◽  
And Control

Abstract Background Considering the prevalence of infertility in the community and the consequences of failure of infertility treatments on women’s mental health, interventions that can control stress, anxiety and depression in infertile women with a history of IVF failure will be very helpful. This study aimed to determine the effects of hope-oriented group counseling on mental health (primary outcome) and quality of life (QoL) (secondary outcome) of women with failed IVF cycles. Method This randomized controlled trial was conducted on 60 women with failed IVF cycles visiting Infertility Clinic at Al-Zahra Teaching Hospital of Tabriz- Iran. Participants were allocated to the intervention group (n = 30) and control group (n = 30) based on a randomized block design. Hope-oriented group counseling was provided to the intervention group in six 45–60 min sessions (once a week). The control group only received routine care to undergo another IVF cycle. The Depression Anxiety Stress Scale-21 (DASS-21) and the SF-12 Quality of Life Scale were filled out by interviewing the participants before the intervention and one week and one month after the intervention. After intervention 26 participants in each group were included in the analysis. Results There was no significant difference between the intervention and control groups in the socio-demographic profile of participants (P > 0.05). The post-intervention mean score of stress (adjusted mean difference = − 1.7, 95% confidence interval: − 3.2 to − 0.3, P = 0.018) and depression (adjusted mean difference = − 1.3, 95% confidence interval: − 4.7 to − 1.5, P < 0.001) was significantly lower in the intervention group compared to the control. Although the mean anxiety score was lower in the intervention group compared to the control, the difference between them was not statistically significant (adjusted mean difference = − 1.1, 95% confidence interval: − 2.6 to 0.4, P = 0.153). The mean score of QoL was significantly higher in the intervention group than that of the control group (adjusted mean difference = 6.9, 95% confidence interval: 5.1 to 8.8, P < 0.001). Conclusion Hope-oriented group counseling was effective in reducing stress and depression and improving QoL in women with failed IVF cycles. It is recommended to use this counseling approach, along with other methods, to improve the mental health of women with failed IVF cycles. Trial registration TCT Registration Number: TCTR 20191017003, registered on October 17, 2019.

scholarly journals Effect of Self-care Training on Upper Limb Function and Pain After Breast Cancer Surgery

2021 ◽  
Vol 10 (2) ◽  
Author(s):  
Somyye Noura ◽  
Fatemeh Kiani ◽  
Nezarali Moulaei ◽  
Mojtaba Tasbandi ◽  
Ebrahim Ebrahimi Tabas
Keyword(s):  
Breast Cancer ◽  
Upper Limb ◽  
Intervention Group ◽  
Self Care ◽  
Control Group ◽  
Limb Function ◽  
Upper Limb Function ◽  
Care Training ◽  
The Mean ◽  
And Control

Background: Breast cancer patients who undergo mastectomy encounter numerous problems, the most annoying of which is lymphedema followed by pain and decreased function in the affected limb. Objectives: This study examined the effect of self-care training on upper limb function and pain after breast surgery. Methods: This quasi-experimental study was performed on two groups of 60 patients with breast cancer in the Oncology Ward of Zahedan University of Medical Sciences in 2021. The patients were selected based on the inclusion criteria and through convenience sampling and were then randomly divided into intervention and control groups. The patients in the intervention group attended self-care training and exercise programs implemented in five sessions in addition to the routine care. One and three months after the intervention, upper limb function and pain were measured with DASH and McGill pain questionnaires. The repeated measures analysis of variance (ANOVA) and Bonferroni test were used to compare the pre-, and post-intervention mean scores and mean differences in the two groups. Results: The mean scores of upper limb function one and three months after the training program in the intervention group were lower than the mean scores of the control group. In other words, the quality of upper limb function was not significantly different despite the changes in the first month, but upper limb function significantly improved three months after the intervention (P < 0.001 vs. P = 0.06). The mean pain scores before, one month, and three months after the intervention in the intervention group were 10.4, 35.7, and 6.26, respectively, and the corresponding values in the control group were 10.8, 41.7, and 21.1, respectively, showing significant differences between the two groups, with the intervention group having lower pain scores than the control group (P = 0.001). Conclusions: Since lymphedema and its consequences, including decreased upper limb function and pain, are very serious issues, medical staff can give priority to this training program and implement it to prevent and control these complications.

scholarly journals Effect of Education Based on Extended Theory of Planned Behavior on Exclusive Breastfeeding in Pregnant Women in Darmian in 2017

Health Scope ◽  
2020 ◽  
Vol 9 (3) ◽  
Author(s):  
Hajar Rasoli ◽  
Gholamreza Masoudy ◽  
Hossein Ansari ◽  
Hossein Bagheri
Keyword(s):  
Theory Of Planned Behavior ◽  
Pregnant Women ◽  
Planned Behavior ◽  
Exclusive Breastfeeding ◽  
Intervention Group ◽  
Control Group ◽  
Validity And Reliability ◽  
Extended Theory ◽  
The Mean ◽  
And Control

Background: Appropriate breastfeeding reduces health disorders and death among infants. Objectives: The present study was conducted to evaluate the effects of educational intervention based on the extended theory of planned behavior. Methods: In this semi-experimental study, 168 pregnant women from 20 health centers were allocated into intervention and control groups by a multi-stage sampling method. The data collecting tool included demographic and constructs of an extended theory of planned behavior. The validity and reliability of the questionnaire were confirmed by an expert panel and Cronbach's alpha test, respectively. The educational methods encompassed face to face training, pamphlet and flashcards distribution, and clip presentation. Two 45-minute educational sessions were conducted; the data were recollected 6 months after the delivery. Results: The mean ages of the intervention and control group were 29 ± 6 and 28.7 ± 5.9. The pregnancy rate and age of the pregnancy in the intervention group were 2.7 ± 1.4 and 29 weeks, respectively. After the intervention, the mean score of the behavior in the intervention group increased compared to the control group. The intention (B = 0.4, P = 0.01) and perceived behavior control (B = 0.42, P = 0.03) were the predictors of the behavior. Conclusions: The structures of the extended theory of planned behavior are suitable framework to promote exclusive breastfeeding among pregnant women.

scholarly journals Facebook as a Novel Tool for Continuous Professional Education on Dementia: Pilot Randomized Controlled Trial

10.2196/16772 ◽  
2020 ◽  
Vol 22 (6) ◽  
pp. e16772 ◽  
Author(s):  
Windy SY Chan ◽  
Angela YM Leung
Keyword(s):  
Professional Education ◽  
Retention Rate ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Multiple Choice Questions ◽  
Participant Engagement ◽  
Significant Difference ◽  
The Mean ◽  
And Control

Background Social network sites (SNSs) are widely exploited in health education and communication by the general public, including patients with various conditions. Nevertheless, there is an absence of evidence evaluating SNSs in connecting health professionals for professional purposes. Objective This pilot randomized controlled trial was designed to evaluate the feasibility of an intervention aiming to investigate the effects of a continuous professional education program utilizing Facebook to obtain knowledge on dementia and care for patients with dementia. Methods Eighty health professionals from Hong Kong were recruited for participation in the study and randomized at a 1:1 ratio by a block randomization method to the intervention group (n=40) and control group (n=40). The intervention was an 8-week educational program developed to deliver updated knowledge on dementia care from a multidisciplinary perspective, either by Facebook (intervention group) or by email (control group) from October 2018 to January 2019. The primary outcomes were the effects of the intervention, measured by differences in the means of changes in pre- and postintervention scores of knowledge assessments from the 25-item Dementia Knowledge Assessment Scale (DKAS) and formative evaluation of 20 multiple choice questions. Other outcome measurements included participant compliance, participant engagement in Facebook, satisfaction, and self-perceived uses of Facebook for continuing professional education programs. Results Significantly more intervention group participants (n=35) completed the study than the control group (n=25) (P<.001). The overall retention rate was 75% (60/80). The mean of changes in scores in the intervention group were significant in all assessments (P<.001). A significant difference in the mean of changes in scores between the two groups was identified in the DKAS subscale Communication and Behavior (95% CI 0.4-3.3, P=.02). There was no significant difference in the total DKAS scores, scores of other DKAS subscales, and multiple choice questions. Participant compliance was significantly higher in the intervention group than in the control group (P<.001). The mean numbers of participants accessing the learning materials were 31.5 (SD 3.9) and 17.6 (SD 5.2) in the intervention and control group, respectively. Polls attracted the highest level of participant engagement, followed by videos. Intervention group participants scored significantly higher in favoring the use of Facebook for the continuing education program (P=.03). Overall, participants were satisfied with the interventions (mean score 4 of a total of 5, SD 0.6). Conclusions The significantly higher retention rate, together with the high levels of participant compliance and engagement, demonstrate that Facebook is a promising tool for professional education. Education delivered through Facebook was significantly more effective at improving participants’ knowledge of how people with dementia communicate and behave. Participants demonstrated positive attitudes toward utilizing Facebook for professional learning. These findings provide evidence for the feasibility of using Facebook as an intervention delivery tool in a manner that can be rolled out into practical settings.

scholarly journals The Effect of Black Tea (Camellia sinensis (L) Kuntze) on Pediatrics With Acute Nonbacterial Diarrhea

2016 ◽  
Vol 22 (1) ◽  
pp. 114-119 ◽  
Author(s):  
Sareh Doustfatemeh ◽  
Mohammad Hadi Imanieh ◽  
Abdolali Mohagheghzade ◽  
Mohammad M. Zarshenas ◽  
Zahra Torkamani ◽  
...  
Keyword(s):  
Standard Treatment ◽  
Intervention Group ◽  
Black Tea ◽  
Control Group ◽  
Old Patients ◽  
Significant Difference ◽  
The Mean ◽  
And Control ◽  
Single Blind

We aimed to evaluate the antidiarrheal effect of black tea in pediatric patients with acute nonbacterial diarrhea. This single-blind randomized clinical trial study was performed on 2 to 12-year-old patients, with acceptable criteria for acute nonbacterial diarrhea in Shiraz, Iran. In total, 120 patients took part in this study. Blocked randomization method was used to allocate them into 2 groups of intervention (black tea tablet + standard treatment) and control group (standard treatment; 60 patients in each). Frequency of defecation, volume, and consistency of stool were registered on arrival and 24 hours later. We used χ2 test, t test, and Mann-Whitney U test. After a 24-hour follow-up, the proportion of patients with formed stool was higher in the intervention group when compared with the control group ( P < .001). There was a significant difference between the mean number of defecations per 24 hours in both groups, after treatment ( P < .001). We found a possible antidiarrheal effect of black tea.

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