Tracking demographic movements and immunization status to improve children access to immunization (TDM-IAI): A Field-Based Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Jérôme Ateudjieu ◽  
Ketina Hirma Tchio Nighie ◽  
André Pascal Goura ◽  
Martin Yakum Ndinakie ◽  
Miltiade Dieffi Tchifou ◽  
...  
Keyword(s):  
Age Groups ◽  
Intervention Group ◽  
Vaccination Status ◽  
Control Group ◽  
Randomized Controlled ◽  
Community Volunteers ◽  
Recorded Data ◽  
Vaccination Timeliness ◽  
Catch Up ◽  
Present Trial

BACKGROUND Vaccines offered by countries’ expanded program on immunization contribute to the reduction of mortality and morbidity, but access to these vaccines remains quite limited in most developing countries. OBJECTIVE The present trial assesses whether involving Community Volunteers (CV) to track children vaccination status and demographic movements and using recorded data to plan catch-up immunization sessions can improve children vaccination timeliness, completeness and coverage. METHODS This was a randomized controlled field trial in which communities of the Foumban Health district based in West region of Cameroon were allocated to intervention or control groups. In the intervention group, a CV per community was trained to visit households monthly for a year to record EPI targeted children in a Community EPI register (CER), their demographic movements and assess their immunization status. CER recorded page was snapped and sent to health center immunization team through WhatsApp and used to plan and implement monthly community catch up immunization sessions. In the control group, the EPI immunization sessions were conducted as routinely. Surveys were conducted at 6 (midline) and 12 (end line) months from the beginning of the intervention in both study groups to assess and compare immunization timeliness, coverage and completeness. RESULTS Thirty-two clusters per study group of about 160 buildings were followed for a year. In each cluster, a sample of 30 building was selected and surveyed at midline and endline. Of 792 and 876 households (HH) targeted for surveys in midline and end line in the intervention groups, 98.0% and 99.5% were reached respectively whereas in the control group, 1296 and 722 HH were targeted and 72.3% and 70.2% reached in midline and endline surveys respectively. One year after the implementation of the intervention, the timeliness of BCG administration in the first month of life did not increase in the intervention group compared to the control group for the age groups 0-11 (adjOR = 1.1 (0.7-1.8)) and 0-59 months (AdjOR=1.1(0.9-1.4)); meanwhile the increase was significant for the first year BCG administration for the age group 0-23 months (adjusted (AdjOR= 1.5 (1.1-2.2)). The coverage of DPT-Hi+Hb3 (AdjOR= 2.0 (1.5-2.7)), DPT-Hi+Hb1(adjOR= 1.8 (1.4-2.4)) significantly increased in the intervention group compared to the control group in age groups 12-59 and 12-23 months. Specific (DPT-Hi+Hb1 to DPT-Hi+Hb3) (AdjOR= 1.9 (1.4-2.6)) and general (BCG to measles) (AdjOR=1.5 (1.1-2.1)) vaccine completeness increased significantly in the intervention group compared to the control group. CONCLUSIONS Results of the present trial support that involving Community Volunteers to track children vaccination status and demographic movements and using recorded data to plan catch-up immunization sessions improve children vaccination timeliness, completeness and coverage. If its consistency is verified in other contexts, this strategy should be adopted to improve access to vaccination for EPI target populations. CLINICALTRIAL Pan African Clinical Trials Registry ID: PACTR201808527428720; Approved and registered on the August 22, 2018.

scholarly journals Tracking demographic movements and immunization status to improve children access to immunization (TDM-IAI): A cluster randomized controlled trial protocol. (Preprint)

2020 ◽  
Author(s):  
Jerome Ateudjieu ◽  
Ndinakie Martin Yakum ◽  
Andre Pascal Goura ◽  
Etienne Guenou ◽  
Landry Bita’a Beyala ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Vaccination Status ◽  
Randomized Controlled ◽  
Community Volunteer ◽  
Community Volunteers ◽  
Recorded Data ◽  
Vaccination Timeliness ◽  
Catch Up ◽  
Cluster Randomized

BACKGROUND In Cameroon, the coverage, completeness, and timeliness of EPI vaccines administration in children have remained heterogeneous and below the national and districts targets in several districts. In an effort to solve this problem, many interventions have been tested but none has shown significant improvement of the situation. OBJECTIVE Test whether involving Community Volunteers to assess children's vaccination status and demographic movements and using recorded data to plan catch-up immunization sessions can improve children's vaccination timeliness, completeness, and coverage. METHODS This is a cluster randomized controlled trial which aims to test whether involving Community Volunteers to assess children vaccination status and demographic movements and using recorded data to plan catch-up immunization sessions can improve children vaccination timeliness, completeness and coverage. Communities of the Foumban Health district, West region of Cameroon will be selected and assigned to either intervention or control groups using a restricted randomization of 2. In the intervention group, one Community Volunteer per community will be trained to visit households and record EPI targeted children in a register, their demographic movements and assess at monthly base their immunization status monthly for a year. The information recorded will be snapped and sent to the competent health center immunization team through WhatsApp. These will be used to plan and implement monthly community catch up immunization sessions in collaboration with the community volunteer. In the control group, the routine immunization sessions will be conducted with health centers organizing either weekly vaccination sessions for communities situated not farther than 5 kilometers away from the health facility or monthly vaccination sessions in communities situated more than 5 kilometers away from the health center. Baseline, mid-term and end-line surveys will be conducted to assess and compare immunization coverage, timeliness and completeness. RESULTS Discussion: This trial is expecting to test an innovative approach to improving children’s immunization timeliness, completeness and coverage by tracking EPI targeted population vaccination status and denominator at household level and building collaboration between the community and health facilities vaccination teams to organize monthly community-based response vaccination sessions. CONCLUSIONS This intervention is expected to improve children sustainable access to EPI vaccination as it offers assessing and responding to their immunization needs at monthly basis using low cost local human resources. CLINICALTRIAL Pan African Clinical Trials Registry PACTR201808527428720. Prospectively registered 22 August 2018.

scholarly journals Improving the Driving of Community-Dwelling Older Canadians: A Randomized Controlled Trial

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 730-730
Author(s):  
Brenda Vrkljan ◽  
Ruheena Sangrar ◽  
Lauren Griffith ◽  
Lori Letts ◽  
Michelle Porter
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Age Groups ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Driver Training ◽  
Older Driver ◽  
Randomized Controlled

Abstract Older Canadians, similar to aging drivers in many other countries, want to drive, need to drive, and live in communities where driving is both valued and necessary for out-of-home participation. Many community-dwelling seniors are medically fit-to-drive, yet their collision risk remains higher than most other age groups, which some have attributed to their propensity to drive shorter distances in high-traffic areas (Antin et al., 2017). In this randomized controlled trial, the effect of a customized video-based older driver training program on behind-the-wheel performance was captured using the latest technology for an on-road evaluation. Results indicated the mean reduction in number of driving errors [mean (95% CI)=-12.0(-16.5, -7.6),p<0.001] favoured the intervention group where their change between baseline and 4-week follow-up was statistically significant [mean(95% CI)=-10.3(-13.8, -6.8),p<0.001], but not for the control group [mean (95% CI)=1.7(-0.08, 4.2), p>0.05]. Our novel, video-based approach that provided individualized feedback improved driving performance for older drivers. Part of a symposium sponsored by Transportation and Aging Interest Group.

Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  
Keyword(s):  
International Students ◽  
Acculturative Stress ◽  
Educational Program ◽  
Public Universities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Policy Makers ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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 Feasibility Study of an Educational Intervention to Improve Water Intake in Adolescent Soccer Players: A Two-Arm, Non-Randomized Controlled Cluster Trial

2021 ◽  
Vol 18 (3) ◽  
pp. 1339
Author(s):  
Rubén Martín-Payo ◽  
María del Mar Fernández-Álvarez ◽  
Edurne Zabaleta-del-Olmo ◽  
Rebeca García-García ◽  
Xana González-Méndez ◽  
...  
Keyword(s):  
Educational Intervention ◽  
Water Consumption ◽  
Intervention Group ◽  
Soccer Players ◽  
Consumption Pattern ◽  
Control Group ◽  
Personal Factors ◽  
Cluster Trial ◽  
Randomized Controlled ◽  
Ad Libitum

This study aimed to assess the feasibility of an educational intervention on hydration behavior in adolescent soccer players. A pilot study of a two-arm, non-randomized controlled cluster trial was conducted. A total of 316 players aged 13–16 agreed to participate. The response variables were the players’ participation in the intervention, their perception of the knowledge acquired, the usefulness and the overall assessment of the intervention. Hydration patterns and acquisition of knowledge on hydration behavior were also assessed. The intervention involved two elements: posters and a web app. A total of 259 adolescents completed the study (intervention group (IG) = 131; control group (CG) = 128). 80.6% of the players responded to the survey assessing the feasibility of the intervention. The mean number of correct answers regarding behavior was significantly higher in the IG (3.54; SD = 1.162) than in the CG (2.64; SD = 1.174) (p < 0.001). The water consumption pattern at all the clubs was ad libitum. Of the players, 10% did not drink any water at all during the game. In conclusion, this intervention has been shown to be feasible for implementation with adolescent soccer players. It suggests that hydration guidelines should be informed by personal factors and that ad libitum water consumption should be avoided.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

scholarly journals Short-term balance training and acute effects on postural sway in balance-deficient older adults: a randomized controlled trial

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Niklas Sörlén ◽  
Andreas Hult ◽  
Peter Nordström ◽  
Anna Nordström ◽  
Jonas Johansson
Keyword(s):  
Older Adults ◽  
Postural Sway ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Eyes Closed ◽  
Balance Exercise

Abstract Background We aimed to determine the effectiveness of 4 weeks of balance exercise compared with no intervention on objectively measured postural sway. Methods This was a single-center parallel randomized controlled, open label, trial. A six-sided dice was used for allocation at a 1:1-ratio between exercise and control. The trial was performed at a university hospital clinic in Sweden and recruited community-dwelling older adults with documented postural instability. The intervention consisted of progressively challenging balance exercise three times per week, during 4 weeks, with follow-up at week five. Main outcome measures were objective postural sway length during eyes open and eyes closed conditions. Results Sixty-five participants aged 70 years (balance exercise n = 32; no intervention n = 33) were randomized. 14 participants were excluded from analysis because of early dropout before follow-up at week five, leaving 51 (n = 22; n = 29) participants for analysis. No significant differences were detected between the groups in any of the postural sway outcomes. Within-group analyses showed significant improvements in hand grip strength for the intervention group, while Timed Up & Go improvements were comparable between groups but only statistically significant in the control group. Conclusions Performing balance exercise over a four-week intervention period did not acutely improve postural sway in balance-deficient older adults. The lower limit in duration and frequency to achieve positive effects remains unclear. Trial registration Clinical trials NCT03227666, July 24, 2017, retrospectively registered.

scholarly journals Green tea intake and its effect on laboratory parameters and disease symptoms in hospitalised patients with Covid 19: a structured protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sara Mahmoodi ◽  
Mojtaba Yousefi ◽  
Omid Sadeghi ◽  
Ali Mahmoodabadi ◽  
Mohammadreza Sadriirani ◽  
...  
Keyword(s):  
Green Tea ◽  
Controlled Trial ◽  
Intervention Group ◽  
Total Sample ◽  
Control Group ◽  
List Type ◽  
Disease Symptoms ◽  
Laboratory Parameters ◽  
Randomized Controlled ◽  
Full Protocol

Abstract Objectives The current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and complete blood count (CBC) in patients with mild-to-moderate Covid-19 infection. Trial design Randomized, double-blinded, parallel (1:1 ratio) clinical trial exploratory study Participants We will recruit patients with COVID-19 infection admitted to Yasuj Shahid Jalil Hospital in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran. Participants’ inclusion criteria are as follows: Inclusion Criteria Patients aged ≥18 years COVID-19 diagnosis according to real-time polymerase chain reaction (RT-PCR) Exclusion Criteria Pregnancy or lactation Disseminated intravascular coagulation or any other types of coagulopathy Severe congestive kidney failure Having a history of participating in a clinical trial during the last 30 days Intervention and comparator Intervention: Two capsules containing 450 mg green tea extract along with routine treatment for COVID-19 patients in the intervention group. Two capsules containing placebo plus routine treatment for patients with COVID-19 infection. Capsules will be taken twice a day, after lunch and dinner, for 14 days. Main outcomes Changes in disease symptoms and laboratory parameters including CRP, ESR, and CBC after 14 days of the intervention compared to control group. Randomisation Eligible patients will be randomly assigned into the intervention or control group in a 1:1 ratio. Randomization will be performed based on 8 permuted blocks with block sizes of 10, and patients in the intervention and control groups will be matched according to sex and age categories. Randomization will be done using computer-generated random numbers (Randomization.com) Blinding (masking) The appearance of placebo and green tea capsules will be similar in terms of shape and color, and they will be packed in the same bags that will be prepared by the company. Also, the researcher and all participants will not be aware of the divisions until the end of the study. Numbers to be randomised (sample size) The total sample was determined based on CRP MCID in which high CRP levels were considered >2.6 mg/L. Accordingly, a total sample size of 37 patients for each intervention group was required. Trial Status The protocol is Version 1.0, on June 5, 2021. Recruitment will start on July 11, 2021, which is anticipated to be completed by September 21, 2021. Trial registration IRCT20150711023153N3 (https://www.irct.ir/trial/55948) retrospectively registered on June 4, 2021 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting was eliminated; this Letter serves as a summary of the key elements of the full protocol.

Sign in / Sign up

Export Citation Format

Share Document