Design-Based Estimators for Average Treatment Effects for Multi-Armed RCTs

Design-based methods have recently been developed as a way to analyze randomized controlled trial (RCT) data for designs with a single treatment and control group. This article builds on this framework to develop design-based estimators for evaluations with multiple research groups. Results are provided for a wide range of designs used in education research, including clustered and blocked designs. Because analysis in the multi-armed setting involves pairwise contrasts across the research groups, the key methodological question addressed is: How do the estimators for the two-group design need to be adjusted for multi-armed trials? The critical insight is that in multi-armed trials where the goal is to identify the most effective treatments, the samples for each pairwise contrast are representative of the full set of randomized units, not just of themselves. The implication is that variance terms need to be adjusted slightly under the finite-population framework that can reduce precision, and blocks need to be weighted to reflect the full randomized sample in the block or biases can result. An empirical example using data from a multi-armed education RCT demonstrates the issues.

Download Full-text

A Collaborative Deprescribing Intervention in a Subacute Medical Outpatient Clinic: A Pilot Randomized Controlled Trial

Metabolites ◽

10.3390/metabo11040204 ◽

2021 ◽

Vol 11 (4) ◽

pp. 204

Author(s):

Anissa Aharaz ◽

Jens Henning Rasmussen ◽

Helle Bach Ølgaard McNulty ◽

Arne Cyron ◽

Pia Keinicke Fabricius ◽

...

Keyword(s):

Pilot Study ◽

Controlled Trial ◽

Inappropriate Medication ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Patient Interviews ◽

Number Of Patients ◽

Multimorbid Patients ◽

And Control

Medication deprescribing is essential to prevent inappropriate medication use in multimorbid patients. However, experience of deprescribing in Danish Subacute Medical Outpatient Clinics (SMOCs) is limited. The objective of our pilot study was to evaluate the feasibility and sustainability of a collaborative deprescribing intervention by a pharmacist and a physician to multimorbid patients in a SMOC. A randomized controlled pilot study was conducted, with phone follow-up at 30 and 365+ days. A senior pharmacist performed a systematic deprescribing intervention using the Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) criteria, the Danish deprescribing list, and patient interviews. A senior physician received the proposed recommendations and decided which should be implemented. The main outcome was the number of patients having ≥1 medication where deprescribing status was sustained 30 days after inclusion. Out of 76 eligible patients, 72 (95%) were included and 67 (93%) completed the study (57% male; mean age 73 years; mean number of 10 prescribed medications). Nineteen patients (56%) in the intervention group and four (12%) in the control group had ≥1 medication where deprescribing status was sustained 30 days after inclusion (p = 0.015). In total, 37 medications were deprescribed in the intervention group and five in the control group. At 365+ days after inclusion, 97% and 100% of the deprescribed medications were sustained in the intervention and control groups, respectively. The three most frequently deprescribed medication groups were analgesics, cardiovascular, and gastrointestinal medications. In conclusion, a collaborative deprescribing intervention for multimorbid patients was feasible and resulted in sustainable deprescribing of medication in a SMOC.

Download Full-text

The Repercussion of Ai Chi on Aged People’s Balance

European Journal of Investigation in Health, Psychology and Education ◽

10.3390/ejihpe4030023 ◽

2014 ◽

Vol 4 (3) ◽

pp. 247-256

Author(s):

Pablo Javier Olabe Sánchez ◽

Andrés Martínez-Almagro Andreo

Keyword(s):

Fall Prevention ◽

Controlled Trial ◽

Intervention Group ◽

The Other ◽

Control Group ◽

Aged People ◽

Randomized Controlled ◽

Risk Of Fall ◽

And Control ◽

Positive Effect

To practice strength and balance activities are shown as useful tools to fall prevention by diverse metanalysis. On the other side, aquatic environment offers interesting properties for a therapeutic reeducation, being the Ai Chi one of its applications. Aim: To evaluate the repercussion of an Ai Chi programme on aged people’s balance. Method: A randomized controlled trial was developed comparing two groups formed by aged people with risk of fall according to the Timed Up & Go test. Intervention Group (IG) followed twelve Ai Chi sessions combined with their thermal programme; and Control Group (CG) just followed the thermal programme. Both groups spent two weeks in the Balneario of Archena (Murcia, Spain). Results: Both groups improve their balance; however, only the IG reached the non-risk of fall from the Timed Up & Go test. Conclusions: The combination of Ai Chi sessions and a thermal programme had a positive effect on aged people’s balance, showing a therapeutic and clinical relevance.

Download Full-text

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

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0245 ◽

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.

Download Full-text

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

Clinical Rehabilitation ◽

10.1177/02692155211041104 ◽

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.

Download Full-text

Exploring Fathers’ Engagement With Home Visiting: The Tennessee Dad Project

Families in Society The Journal of Contemporary Social Services ◽

10.1177/1044389420901640 ◽

2020 ◽

Vol 101 (4) ◽

pp. 498-513

Author(s):

Heidi E. Stolz ◽

Melissa Rector LaGraff ◽

K. Nicole Mullican ◽

Lisa A. Connor ◽

Meagan J. Green ◽

...

Keyword(s):

Mixed Models ◽

Treatment Condition ◽

Home Visit ◽

Home Visiting ◽

Controlled Trial ◽

Nonresidential Fathers ◽

Randomized Controlled ◽

Using Data ◽

Cluster Randomized ◽

And Control

This study explores fathers’ engagement with home visiting in the “Tennessee Dad” project, a cluster randomized-controlled trial of an in-home parenting education program for fathers delivered alongside a primary home visiting curriculum. Results from three mixed models using data from 2,916 visits with treatment ( n = 113) and control ( n = 117) condition families indicated that visits to treatment condition families were more likely to have a father present than visits to control condition families, but there were no differences between conditions on participation minutes or level of interest. Nonresidential fathers did not differ from married and cohabiting fathers on presence at home visit, controlling for covariates. Implications are discussed, including the need for father-specific materials and father-inclusive funding.

Download Full-text

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

Prevention Science ◽

10.1007/s11121-020-01145-z ◽

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.

Download Full-text

Moxibustion as a Therapy for Breast Cancer–Related Lymphedema in Female Adults: A Preliminary Randomized Controlled Trial

Integrative Cancer Therapies ◽

10.1177/1534735419866919 ◽

2019 ◽

Vol 18 ◽

pp. 153473541986691 ◽

Cited By ~ 3

Author(s):

Chunhui Wang ◽

Ming Yang ◽

Yingyi Fan ◽

Xiaohua Pei

Keyword(s):

Breast Cancer ◽

Scale Score ◽

Controlled Trial ◽

Visual Analog Scale Score ◽

Control Group ◽

Analog Scale ◽

Randomized Controlled ◽

Arm Circumference ◽

Breast Cancer Related Lymphedema ◽

And Control

Objective: To evaluate the effect of moxibustion on relieving breast cancer–related lymphedema. Materials and Methods: A randomized controlled trial was conducted in our institution from March 2016 to March 2017. All patients (N = 48) with cancer-related lymphedema were allocated to 2 groups: a treatment group, in which moxibustion was performed, and a control group, in which pneumatic circulation was performed with compression garments worn every day. Therapeutic efficacy was evaluated by measuring arm circumference (wrist crease, 10 cm proximal to wrist crease, elbow crease, and 10 cm proximal to elbow crease) and determining the Revised Piper Fatigue Scale score and Visual Analog Scale score for swelling before and after treatment. Results: All patients were treated for 4 consecutive weeks. Compared with 0 week after treatment, the affected-side arm circumference after 4 weeks’ treatment decreased in both treatment and control groups; the difference value in the treatment group was superior to that in the control group. Compared with the controls, moxibustion resulted in a lower Visual Analog Scale score. The Revised Piper Fatigue total scores were improved in both the moxibustion and control group, and there was no significant difference between the 2 groups. Moxibustion reduced the behavioral, sensory, emotional, and cognitive Revised Piper Fatigue scores, but only the behavioral and sensory scores improved in the control group. Conclusion: Moxibustion has potential effect on breast cancer–related lymphedema. We present promising preliminary data for larger randomized trials to enable accurate evaluation of moxibustion as a lymphedema treatment.

Download Full-text

Effectiveness of acupuncture vs. core stability training in balance and functional capacity of women with fibromyalgia: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215520911992 ◽

2020 ◽

Vol 34 (5) ◽

pp. 630-645 ◽

Cited By ~ 4

Author(s):

Elisa María Garrido-Ardila ◽

María Victoria González-López-Arza ◽

Maria Jiménez-Palomares ◽

Agustín García-Nogales ◽

Juan Rodríguez-Mansilla

Keyword(s):

Functional Capacity ◽

Dynamic Balance ◽

Controlled Trial ◽

Berg Balance Scale ◽

Core Stability ◽

Control Group ◽

Timed Up And Go ◽

Randomized Controlled ◽

Physiotherapy Programme ◽

And Control

Objective: This study investigated the effectiveness of a core stability training physiotherapy programme vs. acupuncture for the management of balance and functional capacity impairments of women with Fibromyalgia. Design: Single-blind randomized controlled trial. Setting: Outpatients setting. Subjects: Women with Fibromyalgia and balance impairment. Interventions: Participants were randomized to a core stability physiotherapy programme group ( n = 45), acupuncture treatment group ( n = 45) and control group ( n = 45) for 13 weeks. Main Measures: Measures were taken at baseline (week 0), postintervention (week 6) and follow-up (week 13). The primary outcome measures were static balance (posturography) and dynamic balance and functional mobility (Berg Balance Scale, timed up and go test and 10-m walk). The secondary outcome measure was functional capacity (Fibromyalgia Health Assessment Questionnaire and the physical function item from the Spanish Fibromyalgia Impact Questionnaire). Results: In all, 103 participants completed the study. The results showed statistically significant improvements in the acupuncture and physiotherapy groups vs. the control group at week 6 regarding Berg Balance Scale ( P = 0.00, both groups), timed up and go test ( P = 0.00 and P = 0.01, respectively) and 10-m walk test at comfortable speed ( P = 0.02 and P = 0.03, respectively). The 10-m walk test at maximum speed showed significance when comparing the physiotherapy and control group ( P = 0.03). However, no significant differences were found between the physiotherapy and the acupuncture groups. In relation to functional capacity, the improvements achieved after the treatments were not statistically significant. Conclusion: Core stability-based physiotherapy and acupuncture improve dynamic balance and postural control in women with Fibromyalgia.

Download Full-text

Comparison of the effects of Buteyko and pranayama breathing techniques on quality of life in patients with asthma – a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215512450521 ◽

2012 ◽

Vol 27 (2) ◽

pp. 133-141 ◽

Cited By ~ 27

Author(s):

Venkatesan Prem ◽

Ramesh Chandra Sahoo ◽

Prabha Adhikari

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Control Group ◽

Life Questionnaire ◽

Control Groups ◽

Quality Of Life Questionnaire ◽

Randomized Controlled ◽

Questionnaire Score ◽

And Control

Objective: To compare two breathing exercises (Buteyko and pranayama) with a control group in patients with asthma. Design: Randomized controlled trial. Subjects: One hundred and twenty subjects were randomized to three groups through block randomization. Subjects with an Asthma Quality of Life Questionnaire score <5.5 participated in the study. Setting: Outpatient pulmonary medicine department. Interventions: Subjects in the Buteyko and pranayama groups were trained for 3–5 days and instructed to practise the exercises for 15 minutes twice daily, and for three months duration. The control group underwent routine pharmacological management during the study period. Outcome measures: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire and pulmonary function test. Results: The baseline characteristics were similar in all three groups. Post intervention, the Buteyko group showed better trends of improvement (mean (95% confidence interval), P-value) in total Asthma Quality of Life Questionnaire score than the pranayama (0.47 (–0.008–0.95), P = 0.056) and control groups (0.97 (0.48–1.46), P = 0.0001). In comparison between the pranayama and control groups, pranayama showed significant improvement (0.50 (0.01–0.98), P = 0.042) in total Asthma Quality of Life Questionnaire score. Conclusion: The Buteyko group showed better trends of improvement in quality of life and asthma control than the group performing the pranayama breathing exercise.

Download Full-text

Effects of low intensity pulsed ultrasound to reduce the effusion volumes and pain with knee osteoarthritis: a randomized controlled trial

International Journal of Research in Orthopaedics ◽

10.18203/issn.2455-4510.intjresorthop20185145 ◽

2018 ◽

Vol 5 (1) ◽

pp. 77

Author(s):

P. Shanmuga Raju ◽

Chokkarapu Ramu ◽

N. S. Harshavardhan ◽

K. Rajender ◽

G. Sachin

Keyword(s):

Randomized Controlled Trial ◽

Knee Osteoarthritis ◽

Controlled Trial ◽

Control Group ◽

Ultrasound Therapy ◽

Pulsed Ultrasound ◽

Low Intensity Pulsed Ultrasound ◽

Low Intensity ◽

Randomized Controlled ◽

And Control

Background: The study aim was to determine the effect of low intensity pulsed ultrasound therapy to reduce the effusion volumes and pain in patients with Knee OA.Methods: This study design was randomized controlled trial. Total 50 patients diagnosed with Knee osteoarthritis were randomly assigned to two groups. Group I was using treatment of low intensity pulsed ultrasound therapy and group II was administered TENS with home exercise respectively. Treatments were 6 days per week and duration of 2 week. The amount of effusion volume will be measured via ultrasonograpy in knee.Results: The maximum number of cases are lying in age group >60 years which is 28% and 40% in cases and control group respectively and age distribution in both the group is statistically not significant. The mean age of patients in cases and control group is 57.08±7.40 years and 58.04±9.93 years respectively.Conclusions: Low intensity pulsed ultrasound therapy significantly reduced the effusion volumes and pain in patients with knee osteoarthritis.

Download Full-text