Effect of a Mobile Phone–Based Glucose-Monitoring and Feedback System for Type 2 Diabetes Management in Multiple Primary Care Clinic Settings: Cluster Randomized Controlled Trial

Background Recent evidence of the effectiveness of mobile phone–based diabetes management systems is generally based on studies conducted in tertiary hospitals or professional diabetes clinics. Objective This study aimed to evaluate the clinical efficacy and applicability of a mobile phone–based glucose-monitoring and feedback system for the management of type 2 diabetes mellitus (T2DM) in multiple primary care clinic settings. Methods In this multicenter, cluster-randomized controlled, open trial, 13 primary care clinics in Seoul and other large cities in South Korea were voluntarily recruited. Overall, 150 (9 clinics) and 97 (4 clinics) participants with T2DM were assigned to the intervention and control groups, respectively (2:1 allocation). Every month, participants in both groups attended face-to-face physicians’ consultation for the management of diabetes in the clinic. For the intervention group, participants were required to upload their daily self-monitoring of blood glucose (SMBG) results using the mobile phone app in addition to outpatient care for 3 months. The results were automatically transmitted to the main server. Physicians had to check their patients’ SMBG results through an administrator’s website and send a short feedback message at least once a week. At baseline and 3 months, both groups had anthropometry and blood tests, including hemoglobin A1c (HbA1c), and responded to questionnaires about treatment satisfaction and compliance. Results At 3 months, participants in the intervention group showed significantly more improvement in HbA1c (adjusted mean difference to control −0.30%, 95% CI −0.50 to −0.11; P=.003) and fasting plasma glucose (−17.29 mg/dL, 95% CI −29.33 to −5.26; P=.005) than those in the control group. In addition, there was significantly more reduction in blood pressure, and the score regarding treatment satisfaction and motivation for medication adherence increased more in the intervention group than in the control group. In the subgroup analyses, the effect on glycemic control was more significant among younger patients and higher baseline HbA1c levels. Conclusions The mobile phone–based glucose-monitoring and feedback system was effective in glycemic control when applied in primary care clinic settings. This system could be utilized effectively with diverse institutions and patients. Trial Registration Clinical Research Information Service (CRIS) https://tinyurl.com/tgqawbz

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Effect of a Mobile Phone–Based Glucose-Monitoring and Feedback System for Type 2 Diabetes Management in Multiple Primary Care Clinic Settings: Cluster Randomized Controlled Trial (Preprint)

10.2196/preprints.16266 ◽

2019 ◽

Author(s):

Yeoree Yang ◽

Eun Young Lee ◽

Hun-Sung Kim ◽

Seung-Hwan Lee ◽

Kun-Ho Yoon ◽

...

Keyword(s):

Primary Care ◽

Mobile Phone ◽

Diabetes Management ◽

Primary Care Clinic ◽

Intervention Group ◽

Glucose Monitoring ◽

Feedback System ◽

Control Group ◽

Care Clinic ◽

Cluster Randomized

BACKGROUND Recent evidence of the effectiveness of mobile phone–based diabetes management systems is generally based on studies conducted in tertiary hospitals or professional diabetes clinics. OBJECTIVE This study aimed to evaluate the clinical efficacy and applicability of a mobile phone–based glucose-monitoring and feedback system for the management of type 2 diabetes mellitus (T2DM) in multiple primary care clinic settings. METHODS In this multicenter, cluster-randomized controlled, open trial, 13 primary care clinics in Seoul and other large cities in South Korea were voluntarily recruited. Overall, 150 (9 clinics) and 97 (4 clinics) participants with T2DM were assigned to the intervention and control groups, respectively (2:1 allocation). Every month, participants in both groups attended face-to-face physicians’ consultation for the management of diabetes in the clinic. For the intervention group, participants were required to upload their daily self-monitoring of blood glucose (SMBG) results using the mobile phone app in addition to outpatient care for 3 months. The results were automatically transmitted to the main server. Physicians had to check their patients’ SMBG results through an administrator’s website and send a short feedback message at least once a week. At baseline and 3 months, both groups had anthropometry and blood tests, including hemoglobin A1c (HbA1c), and responded to questionnaires about treatment satisfaction and compliance. RESULTS At 3 months, participants in the intervention group showed significantly more improvement in HbA1c (adjusted mean difference to control −0.30%, 95% CI −0.50 to −0.11; P=.003) and fasting plasma glucose (−17.29 mg/dL, 95% CI −29.33 to −5.26; P=.005) than those in the control group. In addition, there was significantly more reduction in blood pressure, and the score regarding treatment satisfaction and motivation for medication adherence increased more in the intervention group than in the control group. In the subgroup analyses, the effect on glycemic control was more significant among younger patients and higher baseline HbA1c levels. CONCLUSIONS The mobile phone–based glucose-monitoring and feedback system was effective in glycemic control when applied in primary care clinic settings. This system could be utilized effectively with diverse institutions and patients. CLINICALTRIAL Clinical Research Information Service (CRIS) https://tinyurl.com/tgqawbz

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Effectiveness of the 5A’s Model for Changing Physical Activity Behaviors in Rural Adults Recruited From Primary Care Clinics

Journal of Physical Activity and Health ◽

10.1123/jpah.2018-0477 ◽

2019 ◽

Vol 16 (12) ◽

pp. 1138-1146

Author(s):

Jill R. Reed ◽

Paul Estabrooks ◽

Bunny Pozehl ◽

Kate Heelan ◽

Christopher Wichman

Keyword(s):

Physical Activity ◽

Primary Care ◽

Primary Care Clinic ◽

Intervention Group ◽

Well Being ◽

Text Messages ◽

Future Research ◽

Control Group ◽

Care Clinic ◽

Rural Adults

Background: Most rural adults do not meet current guidelines for physical activity (PA). A 12-week feasibility study tested the effectiveness of using the 5A’s model for PA counseling on rural adults’ PA behaviors. Methods: Inactive rural adults recruited from a primary care clinic were randomized to an intervention (n = 30) or control (n = 29) group. All subjects wore a Fitbit to track steps and active minutes. The intervention group completed action plans to improve self-regulatory PA strategies and received weekly motivational text messages to improve PA behaviors. Theory of planned behavior constructs and self-regulatory strategies of planning, goal setting, and tracking (steps and active minutes) were measured with both groups. The control group received the Fitbit only. Results: All individuals became more physically active; however, no significant differences between groups in active minutes or steps were found. All subjects, regardless of group, increased steps (P > .05). There were no statistically significant differences between groups on any of the theoretical variables. Conclusions: It is vitally important to continue to find ways to make PA a priority to improve the overall health and well-being of rural adults. Future research warrants adjusting the intervention dose and strategies to increase PA that can be maintained long term.

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FACT effectiveness in primary care; a single visit RCT for depressive symptoms

The International Journal of Psychiatry in Medicine ◽

10.1177/00912174211010536 ◽

2021 ◽

pp. 009121742110105

Author(s):

B Arroll ◽

H Frischtak ◽

R Roskvist ◽

V Mount ◽

F Sundram ◽

...

Keyword(s):

Primary Care ◽

Depressive Symptoms ◽

Primary Care Clinic ◽

Intervention Group ◽

Psychosocial Assessment ◽

Care Practice ◽

Control Group ◽

Number Needed To Treat ◽

Care Clinic ◽

The Mean

Background Patients with depressive symptoms are common in primary care. Brief, simple therapies are needed. Aim Is a focussed acceptance and commitment therapy (FACT) intervention more effective than the control group for patients with depressive symptoms in primary care at one week follow up? Design and setting: A randomised, blinded controlled trial at a single primary care clinic in Auckland, New Zealand. Methods Patients presenting to their primary care practice for any reason were recruited from the clinic waiting room. Eligible patients who scored ≥2 on the PHQ-2 indicating potential depressive symptoms were randomised using a remote computer to intervention or control groups. Both groups received a psychosocial assessment using the “work-love-play” questionnaire. The intervention group received additional FACT-based behavioural activation activities. The primary outcome was the mean PHQ-8 score at one week. Results 57 participants entered the trial and 52 had complete outcome data after one week. Baseline PHQ-8 scores were similar for intervention (11.0) and control (11.7). After one week, the mean PHQ-8 score was significantly lower in the intervention group (7.4 vs 10.1 for control; p<0.039 one sided and 0.078 two sided). The number needed to treat to achieve a PHQ-8 score ≤6 was 4.0 on intention to treat analysis (p = 0.043 two sided). There were no significant differences observed on the secondary outcomes. Conclusion This is the first effectiveness study to examine FACT in any population. The results suggest that it is effective compared with control, at one week, for patients with depressive symptoms in primary care.

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Effectiveness of Immersive Virtual Reality in Alleviating Pain and Anxiety in Children during Immunization in Primary Care: A Pilot Randomized Controlled Trial (Preprint)

10.2196/preprints.27911 ◽

2021 ◽

Author(s):

Zi Ying Chang ◽

Gary Chun-Yun Kang ◽

Eileen Yi Ling Koh ◽

Rodney Jin Kai Fong ◽

Jiasheng Tang ◽

...

Keyword(s):

Primary Care ◽

Virtual Reality ◽

Response Rate ◽

Primary Care Clinic ◽

Intervention Group ◽

Rank Test ◽

Control Group ◽

Immersive Virtual Reality ◽

Childhood Immunization ◽

Care Clinic

BACKGROUND Paediatric immunization is often associated with significant fear and anxiety among the older children and their parents. Their distress may potentially affect their adherence to the childhood immunization schedule and the acceptance of other recommended vaccines by physicians. OBJECTIVE The study primarily aimed to assess the feasibility of using immersive virtual reality (VR) during immunization in children in primary care. The secondary aim was to determine the effectiveness of immersive VR in alleviating pain and anxiety among children, reduction of anxiety of their parents and attending nurses during immunization compared to usual care without VR. METHODS A pilot open-label randomized control trial was conducted at a public primary care clinic in Singapore. Thirty children, aged 4-10 years were randomised to an intervention group (n=15) using VR and a control group (n=15) without VR during immunization. Feasibility was assessed by the response rate to the use of VR. The Faces Pain Scale-Revised (FPS-R) and the Children’s Fear Scale (CFS) were used to determine their pain and anxiety respectively before and after the immunization. The anxiety level of their accompanying parents and attending nurses were evaluated using Visual Analogue Scale (VAS) prior and post-immunization of these children. Change in FPS-R and CFS scores, and anxiety assessment for parents and nurses were assessed using Mann-Whitney U test. Wilcoxon signed rank test was used to assess the difference in the nurses’ experience of using the VR application. RESULTS One child refused to use the VR equipment, constituting a rejection rate of 6.7% (1/15) but no adverse event occurred in the intervention arm. The overall response rate of 88% (30/34) when the parents were approached to participate in the study, indicating feasibility of using VR in childhood immunization. In the intervention group compared to the control group, the change in scores for CFS (median -1, IQR -2 to 0; P=.04), parental VAS (median -4, IQR -5 to -1; P=.04) were significantly decreased. After immunization, nurses scored favourably for VR, in terms of simplicity (median 9.5, IQR 5.72 to 10; P=.01), acceptability (median 10, IQR 5 to 10; P=.005) and willingness to use VR in the future (median 10, IQR 5 to 10; P=.02). CONCLUSIONS Immersive VR is feasible, safe and effective in alleviating anxiety among the children, parents and their attending nurses. Nurses viewed the application of VR in childhood immunization favorably. CLINICALTRIAL ClinicalTrials.gov NCT04748367 ; https://clinicaltrials.gov/ct2/show/NCT04748367

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Pharmacist Review to Simplify Medication Regimens in a VAMC Primary Care Clinic

Journal of Pharmacy Technology ◽

10.1177/875512259601200206 ◽

1996 ◽

Vol 12 (2) ◽

pp. 62-66 ◽

Cited By ~ 4

Author(s):

Paul V Laucka ◽

Will B Webster ◽

Jeffrey Kuch

Keyword(s):

Primary Care ◽

Clinical Pharmacist ◽

Primary Care Clinic ◽

Intervention Group ◽

Pharmacist Intervention ◽

Control Group ◽

Care Clinic ◽

Before And After ◽

Clinical Pharmacist Intervention ◽

Clinic Visits

Objective: To assess the effect of a clinical pharmacist's prospective medication review of patients receiving multiple drug therapy, using the pharmaceutical care process, as determined by the number of concurrent medications the patient is receiving before and after clinic visits. Design: Assigned groups. Setting: Outpatient primary care clinic of a tertiary healthcare Veterans Affairs (VA) medical facility. Patients: Seven hundred twenty-seven patients who had eight or more active medication orders were selected. Four hundred forty-one patients (aged 67.2 ± 10.4 y) were in the intervention group; 286 others (aged 66.6 ± 11.9 y), whose medical records were not available, were assigned to the control group and received no clinical pharmacist intervention. Intervention: Medication regimens of VA ambulatory patients with eight or more active medications were reviewed by a clinical pharmacist, and a written communication to the prescriber was attached to the medical record. Main Outcome Measures: The number of active concurrent medications before and after clinic visits was measured. Results: There was a decrease in the medications in the intervention group from an average of 12.1 ±4 to 11.5 ± 4.2 (p < 0.05). The medications in the control group rose from an average of 11.8 ± 4.44 to 12.2 ± 4 (p = NS). A decrease of 0.6 prescriptions per patient was highly significant (p < 0.05). During the study, 1,336 recommendations were made to practitioners. From this group, 41% of the recommendations were accepted, and 477 medications were discontinued, the quantity dispensed or dosage was reduced, or an alternative medication was prescribed. Conclusions: These data suggest that clinical pharmacist intervention in an ambulatory care setting can affect practitioner prescribing habits and significantly decrease the number of medications prescribed.

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Benefit of Digital Tools Used for Integrated Personalized Diabetes Management: Results From the PDM-ProValue Study Program

Journal of Diabetes Science and Technology ◽

10.1177/1932296819867686 ◽

2019 ◽

Vol 14 (2) ◽

pp. 240-249

Author(s):

Lutz Heinemann ◽

Wendelin Schramm ◽

Helena Koenig ◽

Annette Moritz ◽

Iris Vesper ◽

...

Keyword(s):

Health Care Professionals ◽

Diabetes Management ◽

Intervention Group ◽

Digital Tools ◽

Clinical Inertia ◽

Control Group ◽

Traffic Light ◽

Study Program ◽

Therapeutic Concept ◽

Cluster Randomized

Background: Integrated personalized diabetes management (iPDM) is a digitally supported therapeutic concept to improve patient-physician interaction to overcome the aspects of clinical inertia. Integrated personalized diabetes management can support decision making and improve therapeutic outcomes of suboptimally controlled persons with insulin-treated type 2 diabetes (T2D). In this paper, we report the results of an analysis of the PDM-ProValue study program on the effectiveness and perceived benefit of this approach, with a focus on how physicians used and assessed the digital tools provided for the iPDM process. Materials and Methods: The study program included two 12-month, prospective, controlled, cluster-randomized multicenter trials. A total of 101 practices participated with 907 patients. Practices were cluster-randomized to an intervention group and a control group. Digital tools for data visualization and analysis applied were used. HCP were asked to assess the use, relevance, and usefulness of the tools. Results: A clear preference was stated for the visual overview over more statistically complex analyses. A total of 83% of the participants rated a high relevance of the “daily profile,” 81% of the “total profile,” and 68% the “risk illustrated by traffic light symbols” for the therapy decision. The overall iPDM process was very favorably rated with respect to structuredness and potential for personalized treatment and well accepted among health care professionals (HCP). Conclusions: Embedding digital tools in a structured process (iPDM) were proved to provide a benefit for insulin-treated T2D patients and their physicians. These results offer insight for further development and improvement of the tools and add information on how to overcome clinical inertia.

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Effectiveness of a Group Educational Intervention – Prolact - In Primary Care to Promote Exclusive Breastfeeding. A Cluster Randomized Clinical Trial.

10.21203/rs.3.rs-209646/v1 ◽

2021 ◽

Author(s):

María Jesús Santamaría-Martín ◽

Susana Martín Iglesias ◽

Christine Schwarz ◽

Milagros Rico-Blázquez ◽

Julián Alexander Portocarrero-Nuñez ◽

...

Keyword(s):

Primary Care ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Educational Intervention ◽

Exclusive Breastfeeding ◽

Intervention Group ◽

Control Group ◽

Usual Practice ◽

Factors Associated ◽

Cluster Randomized

Abstract Background: The rates of exclusive breastfeeding at 6 months in Spain are far from the target recommended by the World Health Organization, which is 50% by 2025. Evidence of the effectiveness of group interventions in late postpartum is limited. The objective of this study was to evaluate the effectiveness of the PROLACT group educational intervention for increasing the proportion of mother-child dyads with exclusive breastfeeding at 6 months compared to the usual practice in primary care.Method: Multicentre cluster randomized clinical trial. A total of 434 mother-child dyads (215 in the control group and 219 in the intervention group) who breastfed exclusively in the first 4 weeks of the infant's life and agreed to participate were included. The main outcome variable was exclusive breastfeeding at 6 months. Secondary variables were the type of breastfeeding, reasons for abandonment, degree of adherence and satisfaction with the intervention. To study the effectiveness, the difference in the proportions of dyads with exclusive breastfeeding at 6 months was calculated, and the relative risk (RR) and number needed to treat (NNT) were calculated with their 95% CIs. To study the factors associated with the maintenance of exclusive breastfeeding at 6 months, a multilevel logistic regression model was fitted. All analyses were performed according to intention to treat.Results: The percentage of dyads with exclusive breastfeeding at 6 months was 22.4% in the intervention group and 8.8% in the control group. The PROLACT intervention obtained an RR of 2.53 (95% CI 1.54-4.15) and an NNT of 7 (95% CI 5-14). The factors associated with exclusive breastfeeding at 6 months were the PROLACT intervention, OR 3.51 (95% CI 1.55-7.93); age > 39 years, OR 2.79 (95% CI 1.02-7.6); previous breastfeeding experience, OR 2.61 (95% CI 1.29-5.29); monthly income/person > 833.33 €, OR 2.15 (95% CI: 0.996-4.65); planning to start work before the infant was 6 months old, OR 0.35 (0.19-0.63); and use of a pacifier, OR 0.58 (95% CI 0.30-1.11).Conclusions: The PROLACT group educational intervention in primary care is more effective than the usual practice for maintaining exclusive breastfeeding at 6 months.Trial registration: The trial was registered with ClinicalTrials.gov under code number NCT01869920 (03/06/2013).

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Point-of-care testing improves diabetes management in a primary care clinic in South Africa

Primary Care Diabetes ◽

10.1016/j.pcd.2016.09.008 ◽

2017 ◽

Vol 11 (3) ◽

pp. 248-253 ◽

Cited By ~ 14

Author(s):

Lara A. Motta ◽

Mark D.S. Shephard ◽

Julie Brink ◽

Stefan Lawson ◽

Paul Rheeder

Keyword(s):

South Africa ◽

Primary Care ◽

Diabetes Management ◽

Point Of Care ◽

Primary Care Clinic ◽

Point Of Care Testing ◽

Care Clinic

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Effectiveness of a Non-pharmacological Intervention to Control Diabetes Mellitus in a Primary Care Setting in Kerala: A Cluster-Randomized Controlled Trial

Frontiers in Public Health ◽

10.3389/fpubh.2021.747065 ◽

2021 ◽

Vol 9 ◽

Author(s):

Arya Rahul ◽

Sujatha Chintha ◽

Thekkumkara Surendran Anish ◽

Kannamkottapilly Chandrasekharan Prajitha ◽

Pillaveetil Sathyadas Indu

Keyword(s):

Diabetes Mellitus ◽

Primary Care ◽

Randomized Controlled Trial ◽

Glycemic Control ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Baseline Values ◽

Cluster Randomized

Background: Despite being the first Indian state with a dedicated Non-Communicable Disease (NCD) program, glycemic control among a large proportion of patients is low in Kerala. This study tries to find evidence for a standardized non-pharmacological strategy delivered through Junior Public Health Nurses (JPHNs) in achieving and maintaining glycemic control among diabetic patients registered with NCD clinics of primary health care settings.Design: A cluster randomized controlled trial was conducted among adult patients with Diabetes Mellitus attending NCD clinics of primary care settings of South Kerala, India. JPHNs of the intervention group received additional module-based training while standard management continued in the control group. Sequence generation was done by random permuted blocks method and a cluster of 12 patients was selected from each of the 11 settings by computer-generated random numbers. Patients were followed up for 6 months with monthly monitoring of Fasting Blood Sugar (FBS), Post-Prandial Blood Sugar (PPBS), blood pressure, Body Mass Index (BMI), and health-related behaviors. Knowledge and skills/practice of JPHNs were also evaluated. Analysis of Covariance was done to study the final outcome adjusting for the baseline values and a model for glycemic control was predicted using multilevel modeling.Results: We analyzed 72 participants in the intervention group and 60 participants in the control group according to the intention-to-treat principle. The intervention was associated with a significant reduction in FBS (p < 0.001) and PPBS (p < 0.001) adjusting for the baseline values. The achievement of glycemic control was 1.5 (95% CI: 1.05–2.3) times better with intervention and they showed a better trend of maintenance of glycemic control (FBS, p = 0.003 and PPBS, p = 0.039). Adjusting for clustering and the baseline values, the intervention showed a significant effect on FBS (B = −3.1, SE = 0.57; p < 0.001) and PPBS (B = −0.81, SE = 0.3; p < 0.001) with time. Drug adherence score (p < 0.001), hours of physical activity (p < 0.001), BMI (p = 0.002), fruit intake (p = 0.004), and green leafy vegetable intake (p = 0.01) were the major predictors of FBS control. The practice/skills score of the JPHNs significantly improved with intervention (p < 0.001) adjusting for baseline values.Conclusion: A well-designed health worker intervention package incorporated into the existing health system can translate into attitude change and skill development in the health workers which can reflect in the improvement of glycemic control among the patients.Trial registration: [URL: http://www.ctri.nic.in], identifier [CTRI/2017/11/010622].

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Impact of Pharmacist-Led Diabetes Management in Primary Care Clinics

INNOVATIONS in pharmacy ◽

10.24926/iip.v9i2.985 ◽

2018 ◽

Vol 9 (2) ◽

pp. 17

Author(s):

Benjamin Pontefract ◽

Benjamin S. King ◽

Cynthia A. King ◽

David M Gothard

Keyword(s):

Primary Care ◽

Patient Satisfaction ◽

Usual Care ◽

Diabetes Management ◽

Intervention Group ◽

Control Group ◽

Original Research ◽

Diabetic Patients ◽

Primary Care Clinics ◽

The Impact

Purpose: Current literature supports that pharmacists effectively lower hemoglobin A1c (HbA1c) in diabetic patients. Little data exists on pharmacists’ effects on comorbidity management, patient satisfaction, or financial viability of these positions. This study looked to assess the impact of pharmacists on diabetes management compared to usual care. Methods: This multi-site, two-part study includes a retrospective chart review of patients referred to the pharmacist versus usual care within a large academic health system. The pharmacists collaborated under a consult agreement with primary care physicians. The second part of the study assessed patient satisfaction through an abbreviated CG-CAHPS survey. Results:A total of 206 patients with diabetes for an average of 12 years were included. The average patient age was 62 years with 60% of patients identifying as female and 81% as African-American. Patients were enrolled in a 2:1 fashion with 138 patients in the intervention group. Average baseline HbA1c was 10.1% in the intervention group and 9.3% in the control group (p= 0.0125). At 6 months, the mean change in HbA1c was -2.17% and 0.48% for the intervention and control groups respectively (p Conclusion: Pharmacists are effective at lowering HbA1c in primary care clinics, and patients were highly satisfied with these services. While direct revenue from this service did not meet cost, the pharmacist did positively affect outcomes that contribute to reimbursement. Treatment of Human Subjects: IRB review/approval required and obtained Type: Original Research

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