scholarly journals A randomised controlled trial to evaluate a medication monitoring system for TB treatment

2022 ◽  
Vol 26 (1) ◽  
pp. 44-49
Author(s):  
J. Acosta ◽  
P. Flores ◽  
M. Alarcón ◽  
M. Grande-Ortiz ◽  
L. Moreno-Exebio ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Treatment Success ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Second Phase ◽  
Open Label ◽  
Pulmonary Tb ◽  
Tb Treatment ◽  
Significant Difference

BACKGROUND: Adherence to TB treatment and therefore treatment success could be improved using digital adherence technology.OBJECTIVE: To evaluate the effectiveness of a medication event reminder monitor system (MERM) on treatment success and treatment adherence in patients with drug-susceptible pulmonary TB in Perú.METHODS: This was an experimental, randomised, open-label, controlled study conducted among patients in the second phase of TB treatment. The intervention group received their medications through MERM with the support of a treatment monitor, whereas the control group used the usual strategy. Participants were followed until they completed the 54 doses of the second phase of treatment.RESULTS: The study included 53 patients in each group; four in the intervention group withdrew from the study. Treatment success was significantly more frequent in the MERM group (RR 1.15, 95% CI 1.02–1.30; P = 0.0322). There was no significant difference in the adherence outcomes; however, the percentage of patients who missed at least one dose and patients with more than 10% of total doses missed were lower in the intervention group.CONCLUSION: The use of MERM in the second phase of treatment showed a significant improvement in the treatment success rate in patients with drug-susceptible pulmonary TB.

scholarly journals Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024589
Author(s):  
Wen Yao Mak ◽  
Loke Meng Ong ◽  
Bak Leong Goh ◽  
Sunita Bavanandan ◽  
Lily Mushahar ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Open Label ◽  
Randomised Controlled ◽  
End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

A Moxifloxacin-based Regimen for the Treatment of Recurrent, Drug-sensitive Pulmonary Tuberculosis: An Open-label, Randomized, Controlled Trial

2019 ◽  
Vol 70 (1) ◽  
pp. 90-98 ◽  
Author(s):  
Rubeshan Perumal ◽  
Nesri Padayatchi ◽  
Nonhlanhla Yende-Zuma ◽  
Anushka Naidoo ◽  
Dhineshree Govender ◽  
...  
Keyword(s):  
Adverse Events ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Treatment Success ◽  
Control Group ◽  
Open Label ◽  
Serious Adverse Events ◽  
Conversion Rates ◽  
Significant Difference ◽  
Culture Conversion

Abstract Background The substitution of moxifloxacin for ethambutol produced promising results for improved tuberculosis treatment outcomes. Methods We conducted an open-label, randomized trial to test whether a moxifloxacin-containing treatment regimen was superior to the standard regimen for the treatment of recurrent tuberculosis. The primary and secondary outcomes were the sputum culture conversion rate at the end of 8 weeks and the proportion of participants with a favorable outcome, respectively. Results We enrolled 196 participants; 69.9% were male and 70.4% were co-infected with human immunodeficiency virus (HIV). There was no significant difference between the study groups in the proportion of patients achieving culture conversion at the end of 8 weeks (83.0% [moxifloxacin] vs 78.5% [control]; P = .463); however, the median time to culture conversion was significantly shorter (6.0 weeks, interquartile range [IQR] 4.0–8.3) in the moxifloxacin group than the control group (7.9 weeks, IQR 4.0– 11.4; P = .018). A favorable end-of-treatment outcome was reported in 86 participants (87.8%) in the moxifloxacin group and 93 participants (94.9%) in the control group, for an adjusted absolute risk difference of −5.5 (95% confidence interval −13.8 to 2.8; P = .193) percentage points. There were significantly higher proportions of participants with Grade 3 or 4 adverse events (43.9% [43/98] vs 25.5% [25/98]; P = .01) and serious adverse events (27.6% [27/98] vs 12.2% [12/98]; P = .012) in the moxifloxacin group. Conclusions The replacement of ethambutol with moxifloxacin did not significantly improve either culture conversion rates at the end of 8 weeks or treatment success, and was associated with a higher incidence of adverse events. Clinical Trials Registration NCT02114684.

scholarly journals Effect of a phone reminder system on patient-centered tuberculosis treatment adherence among adults in Northwest Ethiopia: a randomised controlled trial

2021 ◽  
Vol 28 (1) ◽  
pp. e100268
Author(s):  
Kassahun Dessie Gashu ◽  
Kassahun Alemu Gelaye ◽  
Richard Lester ◽  
Binyam Tilahun
Keyword(s):  
Controlled Trial ◽  
Treatment Success ◽  
Intervention Group ◽  
Routine Care ◽  
Control Group ◽  
Patient Relationship ◽  
Continuation Phase ◽  
Reminder System ◽  
Tb Treatment ◽  
Randomised Controlled

ObjectivesThis study aimed to evaluate the effect of the phone reminder system on patient-centred TB treatment adherence during continuation phase, where patients are responsible for taking medication at home.MethodsWe conducted a two-arm randomised controlled trial on adult patients with TB during the continuation phase. In the intervention arm, patients received routine care plus phone-based weekly pill refilling and daily medication reminders. In the control arm, participants received only routine care. A covariate adaptive randomisation technique was used to balance covariates during allocation. The primary outcome was adherence to patient-centred TB treatment, and secondary outcomes included provider–patient relationship and treatment outcomes. We applied per-protocol and intention-to-treat analysis techniques.ResultsWe randomised 306 patients to intervention (n=152) and control (n=154) groups. Adherence to patient-centred TB treatment was 79% (110/139) in intervention and 66.4% (95/143) in control groups, with relative risk (RR) (95% lower CI) (RR=1.632 (1.162 to ∞); p=0.018, one tailed). Good provider–patient relationship was 73.3% (102/139) in intervention group and 52.4% (75/143) in control group, p=0.0001. TB treatment success was 89.5% (136/152) in intervention group and 85.1% (131/154) in control group, p=0.1238.ConclusionsMobile phone-based weekly refilling with daily medication reminder system improved adherence to patient-centred TB treatment and provider–patient relationship; however, there was no significant effect on treatment success.Trial registration numberPan African Clinical Trials Registry (PACTR201901552202539).

scholarly journals Comparison of lidocaine, huffing maneuver and combination of both in prevention fentanyl induced cough before induction of anesthesia: a double-blind, prospective, randomized placebo-controlled study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Laleh Dehghanpisheh ◽  
Mohammadhossein Eghbal ◽  
Fatemeh Bagheri Baravati ◽  
Pooya Vatankhah
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Placebo Control ◽  
Anesthesia Induction ◽  
Double Blind ◽  
Lidocaine Group ◽  
Cough Reflex ◽  
Significant Difference

Abstract Background Intravenous bolus injection of fentanyl has been frequently reported to be associated with cough reflex during patient anesthesia. However, the search for the most effective protocol continues. This study aimed to compare the effect of reducing cough reflex after injection of fentanyl in a fusion protocol by combining the injections of lidocaine and Huffing maneuver and comparing with a placebo control group, before anesthesia induction. Methods This prospective randomized controlled trial study was performed on 400 patients who were divided into four groups of combined protocol (group 1), lidocaine group (group 2), Huffing maneuver group (group 3), and the control receiving normal saline (group 4). Then patients were injected with 2. 5 μg /kg fentanyl and monitored for 2 min regarding their cough reflex, as well as the severity. Results In group one, 9 patients (9%), in group two, 45 patients (45%), 22 patients (22%) in group three, and in group four, 75 patients (75%), developed cough reflex following fentanyl injection. Also, 13 patients (13%) developed moderate and 4 (4%) developed severe coughs in the control group reported, while no reports of severe or moderate cough were among the intervention groups. There was a significant difference between the intervention group and the control group both in terms of the rate and severity of the fentanyl-induced cough. Conclusion By using a combination of lidocaine injection along and Huffing maneuver, better results can be obtained in reducing the frequency, and also the severity of cough followed by fentanyl injection. Trial registration The trial was registered with IRCT.IR (09/03/2018-No. IRCT20141009019470N74).

Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Farokh Saljughi ◽  
Mitra Savabi-Esfahani ◽  
Shahnaz Kohan ◽  
Soheila Ehsanpour
Keyword(s):  
Pregnant Women ◽  
Maternal Employment ◽  
Controlled Trial ◽  
Role Play ◽  
Intervention Group ◽  
Control Group ◽  
Maternal Behaviour ◽  
Infant Attachment ◽  
Significant Difference ◽  
History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

The Effect of Reflexology on Labor Pain and Length Among Primiparous Women: A Randomized Controlled Trial

2018 ◽  
Vol 7 ◽  
Author(s):  
Azita Kamjoo
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Labor Pain ◽  
Control Group ◽  
Singleton Pregnancy ◽  
Group Data ◽  
Significant Difference ◽  
Labor Length ◽  
Primiparous Women

Background: Pain control is considered as the key issue in modern midwifery. Along with medical painkillers, reflexology is viewed as a non-medical and noninvasive method. Hence, we aimed to investigate the effect of reflexology on the intensity of pain and length of labor. Materials and Methods: In this clinical trial, participants included 240 Iranian primiparous women with term and singleton pregnancy. Having a 3-4 cm cervical dilatation once they visited the hospital. Through a convenient sampling method, they were selected and then randomly divided into two groups. In the intervention group, reflexology was performed, and the intensity of pain during the active phase of labor along with the length of labor in the active phase was measured by visual analog scale (VAS) and compared with the control group. Data were analyzed using descriptive statistics, t-test, and Mann-Whitney U-test. Result: Data analysis showed a statistically significant difference between the intensity of pain in the 5-7 and 8-10 cm dilatation in the two groups (P=0.01). Moreover, the labor length in the active phase was found to be significantly shorter in the intervention group (P<0.001). Conclusion: It appears that reflexology can lead to a reduction in the pain and length of labor. Therefore, through instructing this technique, a goal of midwifery, which is reducing labor pain and its length can be achieved. Keywords: Reflexology, Labor Pain, Labor Length, Primiparous Women

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Peer-led exercise program for ageing adults to improve physical functions - a randomized trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
D. R. Bouchard ◽  
J. V. Olthuis ◽  
V. Bouffard-Levasseur ◽  
C. Shannon ◽  
T. McDonald ◽  
...  
Keyword(s):  
Physical Function ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Control Group ◽  
Walk Test ◽  
Blood Draw ◽  
Chair Stand ◽  
Significant Difference ◽  
Physical Functions

Abstract Background A peer-led exercise program is one way to empower people sharing similar characteristics to encourage others to be active, but there is a lack of evidence that these programs have physical function and other benefits when delivered to ageing adults. Methods This randomized controlled trial lasting 12 weeks proposed an exercise peer-led program offered to 31 adults aged 50 and above, twice a week, by a trained leader of the same age from March to May 2019. The program was offered for free with limited space and equipment. Valid tests of physical function (e.g., 30-s chair stand, 6-min walk test) were used to assess the functional benefits. Psychosocial outcomes were assessed using self-reported questionnaires and metabolic outcomes via a fasted blood draw. Results A significant difference was found between pre-and post-values in most physical function tests in the intervention group (all p < 0.05). When adjusted for potential confounders, the intervention group was significantly associated with a more significant improvement on the chair stand test (ß = .26; p < 0.001; r2 = 0.26), the arm curl (ß = .29; p < 0.001; r2 = 0.49), as well as the 6-min walk test (ß = -.14; p < 0.001; r2 = 0.62) compared with the control group. Using repetitive measures generalized linear model, the interaction between the changes and the group was significant for all three tests. Benefits were also observed for participants’ stress level and perceived health in the intervention group compared to the control. Finally, no significant difference was observed between groups for metabolic health. Conclusions The current work suggests that a 12-week peer-led exercise program can improve physical function for adults age 50 and above. Trial registration NCT03799952(ClinicalTrials.gov) 12/20/2018.

scholarly journals Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keivan Ranjbar ◽  
Mohsen Moghadami ◽  
Alireza Mirahmadizadeh ◽  
Mohammad Javad Fallahi ◽  
Vahid Khaloo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Group Data ◽  
Significant Difference

Abstract Background Although 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, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on 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). Conclusion In 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).

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