scholarly journals Did awarding badges increase data sharing in BMJ Open ? A randomized controlled trial

2020 ◽  
Vol 7 (3) ◽  
pp. 191818 ◽  
Author(s):  
Anisa Rowhani-Farid ◽  
Adrian Aldcroft ◽  
Adrian G. Barnett
Keyword(s):  
Randomized Controlled Trial ◽  
Data Sharing ◽  
Controlled Trial ◽  
Intervention Group ◽  
Open Data ◽  
Research Articles ◽  
Control Group ◽  
Control Groups ◽  
Randomized Controlled ◽  
And Control

Sharing data and code are important components of reproducible research. Data sharing in research is widely discussed in the literature; however, there are no well-established evidence-based incentives that reward data sharing, nor randomized studies that demonstrate the effectiveness of data sharing policies at increasing data sharing. A simple incentive, such as an Open Data Badge, might provide the change needed to increase data sharing in health and medical research. This study was a parallel group randomized controlled trial (protocol registration: doi:10.17605/OSF.IO/PXWZQ ) with two groups, control and intervention, with 80 research articles published in BMJ Open per group, with a total of 160 research articles. The intervention group received an email offer for an Open Data Badge if they shared their data along with their final publication and the control group received an email with no offer of a badge if they shared their data with their final publication. The primary outcome was the data sharing rate. Badges did not noticeably motivate researchers who published in BMJ Open to share their data; the odds of awarding badges were nearly equal in the intervention and control groups (odds ratio = 0.9, 95% CI [0.1, 9.0]). Data sharing rates were low in both groups, with just two datasets shared in each of the intervention and control groups. The global movement towards open science has made significant gains with the development of numerous data sharing policies and tools. What remains to be established is an effective incentive that motivates researchers to take up such tools to share their data.

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.

Effect of buddy-style intervention on exercise adherence in community-dwelling disabled older adults: A pilot randomized controlled trial

2021 ◽  
pp. 026921552110411
Author(s):  
Hiromichi Takeda ◽  
Katsuhiko Takatori
Keyword(s):  
Older Adults ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Adherence ◽  
Control Group ◽  
Adult Day Care ◽  
Control Groups ◽  
Randomized Controlled ◽  
And Control ◽  
Pilot Randomized Controlled Trial

Objective To assess the preliminary effects of a buddy-style intervention to improve exercise adherence. Design A parallel-group, open-label, pilot randomized controlled trial. Setting Adult day-care centers. Participants Sixty-five disabled older adults. Interventions All participants underwent a 12-week home exercise program, and the intervention group received a 5–10 min buddy-style intervention between older adults in the intervention group once weekly at an adult day-care center. Main measures Based on the exercise log calendar, the number of days of exercise was assessed for each of the three phases: 1–4 weeks, 5–8 weeks, and 9–12 weeks. Short physical performance battery was measured at baseline and after 12 weeks. Results Of the 590 screened older adults, 65 were recruited and 33 were assigned to the intervention group. One participant in each group withdrew before the program began, and four and five patients in the intervention and control groups, respectively, dropped out by the 12-week assessment. Analysis of covariance of the 28 and 26 patients in the intervention and control groups, respectively, for whom exercise log calendars could be retrieved, showed that the intervention group (24.4/28 days) exercised significantly more days than the control group (20.6/28 days) at 9–12 weeks ( P = 0.009). In the between-group effect of the intention-to-treat analysis of short physical performance battery, walking and standing test ( P = 0.790, P = 0.829) were not significantly different, and balance test ( P = 0.049) was significantly better in the control group. Conclusions There was a preliminary effect of the buddy-style intervention to improve exercise adherence.

scholarly journals Effectiveness of an Educational Video in Maternity Wards to Prevent Self-Reported Shaking and Smothering during the First Week of Age: A Cluster Randomized Controlled Trial

2020 ◽  
Vol 21 (8) ◽  
pp. 1028-1036
Author(s):  
Takeo Fujiwara ◽  
Aya Isumi ◽  
Makiko Sampei ◽  
Yusuke Miyazaki ◽  
Fujiko Yamada ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Educational Video ◽  
Health Checkup ◽  
Infant Crying ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
And Control

Abstract This study aimed to investigate whether watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduces self-reported shaking and smothering, at a 1-month health checkup. A cluster randomized controlled trial, stratified by area and hospital function, was employed in 45 obstetrics hospitals/clinics in Osaka Prefecture, Japan. In the intervention group, mothers watched an educational video on infant crying and the dangers of shaking and smothering an infant, within 1 week of age, during hospitalization at maternity wards, without blinding on group allocation. Control group received usual care. A total of 4722 (N = 2350 and 2372 for intervention and control group, respectively) mothers who delivered their babies (still birth and gestational age < 22 weeks were excluded) between October 1, 2014, and January 31 were recruited. Outcomes were self-reported shaking and smothering behaviors, knowledge on infant crying and shaking, and behaviors to cope with infant crying, assessed via a questionnaire at a 1-month health checkup. In all, 2718 (N = 1078 and 1640) responded to the questionnaire (response rate: 58.3%), and analytic sample size was 2655 (N = 1058 and 1597 for intervention and control group, respectively). Multilevel analysis was used to adjust for correlation within the cluster. Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%). Intention-to-treat analysis showed an 89% reduction in the reported prevalence of self-reported shaking (OR: 0.11, 95% CI: 0.02–0.53) due to watching the educational video. However, self-reported smothering behavior showed no significant reduction (OR: 0.66, 95% CI: 0.27–1.60). No side effects were reported. Watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduced self-reported shaking at 1 month of age. UMIN Clinical Trial Registry UMIN000015558.

scholarly journals Effects of Phase IV Pedometer Feedback Home-Based Cardiac Rehabilitation on Cardiovascular Functional Capacity in Patients With Myocardial Infarction: A Randomized Controlled Trial

2019 ◽  
Vol 4 (2) ◽  
pp. 75-80
Author(s):  
Mostafa Dehghani ◽  
Mostafa Cheraghi ◽  
Mehrdad Namdari ◽  
Valiollah Dabidi Roshan
Keyword(s):  
Myocardial Infarction ◽  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Functional Capacity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
Randomized Controlled ◽  
Home Based

Introduction: Pedometer feedback home-based cardiac rehabilitation (PFHCR) programs have been effective in augmenting exercise tolerance. Our aim was to investigate the effects of PFHCR on cardiovascular functional capacity in patients with myocardial infarction (MI).Methods: Forty MI patients were divided into two intervention and two control groups (n=10)in a randomized controlled trial. The intervention group received a PFHCR program including routine medications along with continuous exercise program, whereas the control group received traditional care without PFHCR. Baseline evaluations and cardiovascular stresses were controlled during the 8-week follow-up rehabilitation program in all patients. Data analysis was conducted using one-way ANOVA and paired sample student’s t-test (P ≤ 0.05).Results: At baseline, no significant differences were observed between the groups. After eight weeks of PFHCR, the intervention groups had significantly higher metabolic equivalent(P = 0.001), VO2max (P = 0.001), total exercise times (P = 0.001), and total distance traveled(P = 0.003) when compared with the control groups. However, no significant intra-group or inter-group differences in variables were observed between the men and women.Conclusion: Our results showed that PFHCR exhibited significant optimal effects on the cardiovascular functional capacity in MI patients.

scholarly journals Prenatal Administration of Betamethasone and Neonatal Respiratory Distress Syndrome in Multifetal Pregnancies: A Randomized Controlled Trial

2020 ◽  
Vol 15 (2) ◽  
pp. 164-169
Author(s):  
Fatemeh Abbasalizadeh ◽  
Khadijeh Pouya ◽  
Raana Zakeri ◽  
Rana Asgari-Arbat ◽  
Shamsi Abbasalizadeh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Premature Infants ◽  
Distress Syndrome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Neonatal Outcomes ◽  
Control Group ◽  
Randomized Controlled ◽  
Neonatal Respiratory Distress ◽  
And Control

Background: Neonatal Respiratory Distress Syndrome (NRDS) is one of the most frequent causes of neonatal mortality especially in premature infants. Although it has been well established that maternal antenatal corticosteroid therapy has a positive effect on NRDS reduction, yet the effectiveness of this treatment in multifetal pregnancies is dubious. Objective: We aimed to investigate the effect of betamethasone therapy on the incidence of NRDS in multifetal pregnancies through a randomized controlled trial. Method: 140 women with a multifetal pregnancy at less than 28 weeks’ gestational age were randomly allocated into intervention and control groups. Women at the intervention group received intramuscularly betamethasone (12 mg/kg/BW twice). Neonatal outcomes were evaluated between two groups of intervention and control, and two subgroups of preterm and term births. This study is registered with the Iranian Clinical Trials Registry, number IRCT20180227038879N1. Result: The incidence of NRDS was significantly lower in infants of betamethasone group than the ones in the control group (4.9% vs 18.1%, P=0.034) while it did not show a significant reduction in preterm infants compared to mature ones. Also, the intervention group presented a significant lower neonatal ventilation than the control group (47.2% vs 63.2%, P=0.041). Other neonatal outcomes, including age at birth, birth weight, Apgar score, NICU admission, and the number of mortalities were not significantly different between study groups. Conclusion: Betamethasone therapy during 28-32 weeks of gestation in multifetal pregnancies was associated with better neonatal outcomes through significant reductions in NRDS incidence and requiring ventilator treatment. However, betamethasone administration did not reduce the chance of NRDS in premature infants.

Effectiveness of Mobile Phone-Based Support on Exclusive Breastfeeding and Infant Growth in Nigeria: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Daprim S Ogaji ◽  
Adaku O Arthur ◽  
Innocent George
Keyword(s):  
Randomized Controlled Trial ◽  
Mobile Phone ◽  
Usual Care ◽  
Exclusive Breastfeeding ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Groups ◽  
Randomized Controlled ◽  
The Difference ◽  
And Control

Abstract Background This study examined whether mobile phone-based support improve the rates, duration of exclusive breastfeeding (EBF) as well as infant growth patterns in Nigeria. Methods A 6-month prospective randomized controlled trial with 75 participants assigned to receive ‘usual care’ or ‘mobile phone-based support in addition to usual care’ EBF rates and duration as well as anthropometric measurements of infants before and after intervention were compared using proportions and mean differences. Results Attrition rates of 10.7% and 14.7% were observed in the intervention and control groups, respectively. Treatment groups were identical in all baseline characteristics and participants in the intervention group showed a slower rate of decline in the practice of EBF. The mean difference of 0.6 months (95% confidence interval: −0.22, 1.42) in EBF duration between intervention and control groups was not statistically significant (t = 1.45; p = 0.149). Similarly, the difference in the EBF rates at the 6th month for the intervention (55.2%) and control (46.8%) groups was not statistically significant (χ2 = 0.623; p = 0.430). Although the intervention group had significantly higher mean weight (p = 0.030) and length (p = 0.044) at the 6th month, the difference in the gain in weight and length of these infants over the period was only significant for the weight (p = 0.044). Although the incidence of adverse clinical nutritional status was more in the control group, these differences were not statistically significant. Conclusion Mobile phone-based intervention has positive effects on the rate and duration of EBF as well as the growth of young infants. Sustaining this simple and cheap technology will improve infant wellbeing especially in resource-constrained settings.

scholarly journals A Tailored Advice Tool to Prevent Injuries Among Novice Runners: Protocol for a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Ellen Kemler ◽  
Vincent Gouttebarge
Keyword(s):  
Randomized Controlled Trial ◽  
Injury Prevention ◽  
Preventive Measures ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Prevention Measures ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
And Control

BACKGROUND Besides the beneficial health effects of being active, running is associated with a risk of sustaining injuries. Runners need to change their behavior to increase the use of effective measures and subsequently reduce the number of running-related injuries. OBJECTIVE The RunFitCheck intervention was developed according to an evidence- and practice-based approach to stimulate injury-preventive behavior among novice runners. This paper describes the study design in detail. METHODS A randomized controlled trial with a follow-up period of 5 months will be conducted. The participants will be novice runners. At enrollment, participants will be asked to report injury-preventive measures they usually take during their running activities. After completing the enrollment questionnaire, participants will be randomized to intervention and control groups. The intervention group will have access to the RunFitCheck intervention; the control group will perform their running activities as usual. Participants will be asked to report retrospectively in detail what they have done regarding injury prevention during their running activities at 1, 3, and 5 months after enrollment. Descriptive analyses will be conducted for different baseline variables in the intervention and control group. Relative risks and 95% CIs will be used to analyze behavioral changes according to the intention-to-treat principle. RESULTS The project was funded in 2016 and enrollment was completed in 2017. Data analysis is currently under way and the results are expected to be submitted for publication in 2019. CONCLUSIONS To nullify the negative side effects of running, prevention of training errors is desirable. As the use of injury prevention measures is not compulsory in running, a behavioral change is necessary to increase the use of effective injury-preventive measures and to prevent running-related injuries. CLINICALTRIAL Netherlands Trial Register NTR6381; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6381 (Archived by WebCite at http://www.webcitation.org/736Xjm5jv) INTERNATIONAL REGISTERED REPOR RR1-10.2196/9708

scholarly journals Protocol violations in López-Medina et al.: 38 switched ivermectin (IVM) and placebo doses, failure of blinding, widespread IVM sales OTC in Cali, and nearly identical AEs for the IVM and control groups

2021 ◽  
Author(s):  
David Scheim ◽  
Jennifer A. Hibberd ◽  
Juan Chamie-Quintero
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Controlled Trial ◽  
Control Group ◽  
High Dose ◽  
Control Groups ◽  
Over The Counter ◽  
Randomized Controlled ◽  
Widespread Availability ◽  
And Control

A randomized controlled trial for treatment of mild cases of COVID-19 conducted in Cali, Colombia reported no statistically significant differences in outcomes for its ivermectin (IVM) and placebo arms. A striking anomaly, however, was that certain adverse events (AEs) that are distinctive for the study’s high-dose IVM use occurred at nearly identical rates in its IVM and placebo arms. The backdrop for these indicators of IVM use in study controls was widespread sales of IVM for COVID-19 in the Cali area during the study period, with 1.6 IVM doses sold over the counter for each case of COVID-19. The study compounded these risks of contamination of the control arm with critical errors in blinding and segregation of IVM v. placebo doses. A labeling error substituted IVM for placebo doses of 38 patients. Also, 5% dextrose solution was used for several weeks as a placebo, easily distinguishable from bitter tasting IVM. Given widespread availability and sales of IVM in Cali, lapses in segregation and blinding of IVM and control doses, and IVM-characteristic AEs in controls, the integrity of the study’s control arm was violated. Some useful information can nevertheless be salvaged from outcomes of this study’s IVM treatment arm, which had 0 deaths and generally mild symptoms, with AEs typical for high-dose IVM (replicated in the control group) that were generally mild and transient.

scholarly journals Methylprednisolone or Dexamethasone, Which One Is the Superior Corticosteroid in the Treatment of Hospitalized COVID-19 Patients: A Triple-Blinded Randomized Controlled Trial

2021 ◽  
Author(s):  
Keivan Ranjbar ◽  
Reza Shahriarirad ◽  
Amirhossein Erfani ◽  
Zohre Khodamoradi ◽  
Mohammad Hasan Gholampoor Saadi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
And Control

Abstract BackgroundAlthough almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, unsolved issues remained to choose appropriate corticosteroids treatment for COVID-19. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients.MethodIn this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. Patients were randomly allocated into two groups to receive either methylprednisolone (2mg/kg/day) or dexamethasone (6mg/kg/day). Data was assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8).ResultsThere was no significant variation among the groups on the admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, P = 0.002) and day 10 (2.90 vs. 4.71, P = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group, and the control group, (3.909 vs. 4.873 respectively, P = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (P = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% P = 0.040).ConclusionIn the context of treating hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone.Trial Registration:The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

scholarly journals Clearing the fog: Is Hydroxychloroquine effective in reducing Corona virus disease-2019 progression: A randomized controlled trial

2020 ◽  
Author(s):  
Sultan Mehmood Kamran ◽  
Zill-e-Humayun Mirza ◽  
Arshad Naseem ◽  
Rizwan Azam ◽  
Naqeeb Ullah ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Disease Progression ◽  
Virus Disease ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Military Hospital ◽  
Control Group ◽  
Randomized Controlled ◽  
And Control

AbstractBackgroundHydroxychloroquine (HCQ) has been considered to treat Coronavirus disease 2019 (COVID-19) but data on efficacy is conflicting. we analyzed the efficacy of HCQ) in addition to standard of care (SOC) compared with SOC alone in reducing disease progression in Mild COVID-19MethodsA single centre open label randomized controlled trial during 10th April to 31st May 2020 was conducted at Pak emirates Military Hospital (PEMH) Five hundred patients of both genders having age between 18-80 years with Mild COVID-19 were enrolled. Patients assigned to standard dose of HCQ plus SOC were 349 while 151 patients received SOC (control group). Primary outcome was progression of disease while secondary outcome was PCR negativity on day 7 and 14. The results were analyzed on SPSS version 23. P value <0.05 was considered significant.ResultsMedian age of intervention group (34 ± 11.778 years) and control group (34 ± 9.813 years). Disease progressed in 16 patients, 11 (3.15%) were in intervention group as compared to 5 (3.35%) in control group, (P value = 0.865). PCR negativity in intervention and control groups were (day 7, 182 (52.1%) vs. 54 (35.7%) (P value = 0.001), (day 14, 244 (69.9%) vs. 110 (72.8%) (P value = 0.508). Consecutive PCR negativity at day 7 and 14 was observed in 240 (68.8%) in intervention group compared to 108 (71.5%) in control group. (P value = 0.231).ConclusionAddition of HCQ to SOC in Mild COVID-19 neither stops disease progression nor help in early and sustained viral clearance.Clinical Trial numberNCT04491994 available at ClinicalTrials.gov

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