23 results on '"United States"'
Search Results
2. Correction to: Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial
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B. Joseph Elmunzer, Jose Serrano, Amitabh Chak, Steven A. Edmundowicz, Georgios I. Papachristou, James M. Scheiman, Vikesh K. Singh, Shyam Varadarajulu, John J. Vargo, Field F. Willingham, Todd H. Baron, Gregory A. Coté, Joseph Romagnuolo, April Wood-Williams, Emily K. Depue, Rebecca L. Spitzer, Cathie Spino, Lydia D. Foster, Valerie Durkalski, and on behalf of the SVI study group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE)
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lcsh:R5-920 ,Study Protocol ,Medicine (miscellaneous) ,Pharmacology (medical) ,lcsh:Medicine (General) - Abstract
Background The combination of prophylactic pancreatic stent placement (PSP) – a temporary plastic stent placed in the pancreatic duct – and rectal non-steroidal anti-inflammatory drugs (NSAIDs) is recommended for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. Preliminary data, however, suggest that PSP may be unnecessary if rectal NSAIDs are administered. Given the costs and potential risks of PSP, we aim to determine whether rectal indomethacin obviates the need for pancreatic stent placement in patients undergoing high-risk ERCP. Methods/Design The SVI (Stent vs. Indomethacin) trial is a comparative effectiveness, multicenter, randomized, double-blind, non-inferiority study of rectal indomethacin alone versus the combination of rectal indomethacin and PSP for preventing PEP in high-risk cases. One thousand four hundred and thirty subjects undergoing high-risk ERCP, in whom PSP is planned solely for PEP prevention, will be randomized to indomethacin alone or combination therapy. Those who are aware of study group assignment, including the endoscopist, will not be involved in the post-procedure care of the patient for at least 48 hours. Subjects will be assessed for PEP and its severity by a panel of independent and blinded adjudicators. Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups. Biological specimens will be obtained from trial participants and centrally banked. Discussion The SVI trial is designed to determine whether PSP remains necessary in the era of NSAIDs pharmacoprevention. The associated bio-repository will establish the groundwork for important scientific breakthrough. Trial registration NCT02476279, registered June 2015.
- Published
- 2020
3. Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial
- Author
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Firas Al-Kawas, Harry Aslanian, John Baillie, Filip Banovac, Jonathan M. Buscaglia, James Buxbaum, Amitabh Chak, Bradford Chong, Gregory A. Coté, Peter V. Draganov, Kulwinder Dua, Valerie Durkalski, B. Joseph Elmunzer, Lydia D. Foster, Timothy B. Gardner, Brian S. Geller, Priya Jamidar, Laith H. Jamil, Rajesh N. Keswani, Mouen A. Khashab, Gabriel D. Lang, Ryan Law, David Lichtenstein, Simon K. Lo, Sean McCarthy, Silvio Melo, Daniel Mullady, Jose Nieto, J. Bayne Selby, Vikesh K. Singh, Rebecca L. Spitzer, Brian Strife, Paul Tarnaksy, Jason R. Taylor, Jeffrey Tokar, Andrew Y. Wang, April Williams, Field Willingham, Patrick Yachimski, and In alphabetical order for the INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE)
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Comparative Effectiveness Research ,medicine.medical_specialty ,Time Factors ,Randomization ,Percutaneous ,Decompression ,Medicine (miscellaneous) ,Equivalence Trials as Topic ,Hilar stricture ,law.invention ,Cholangiocarcinoma ,Study Protocol ,03 medical and health sciences ,0302 clinical medicine ,Superiority Trial ,Randomized controlled trial ,Endoscopic retrograde cholangiopancreatography ,law ,Informed consent ,medicine ,Humans ,Multicenter Studies as Topic ,Pharmacology (medical) ,Adverse effect ,Cholangiopancreatography, Endoscopic Retrograde ,lcsh:R5-920 ,Cholestasis ,medicine.diagnostic_test ,business.industry ,Percutaneous transhepatic biliary drainage ,United States ,Surgery ,Treatment Outcome ,Bile Duct Neoplasms ,030220 oncology & carcinogenesis ,Drainage ,030211 gastroenterology & hepatology ,lcsh:Medicine (General) ,business - Abstract
Background The optimal approach to the drainage of malignant obstruction at the liver hilum remains uncertain. We aim to compare percutaneous transhepatic biliary drainage (PTBD) to endoscopic retrograde cholangiography (ERC) as the first intervention in patients with cholestasis due to suspected malignant hilar obstruction (MHO). Methods The INTERCPT trial is a multi-center, comparative effectiveness, randomized, superiority trial of PTBD vs. ERC for decompression of suspected MHO. One hundred and eighty-four eligible patients across medical centers in the United States, who provide informed consent, will be randomly assigned in 1:1 fashion via a web-based electronic randomization system to either ERC or PTBD as the initial drainage and, if indicated, diagnostic procedure. All subsequent clinical interventions, including crossover to the alternative procedure, will be dictated by treating physicians per usual clinical care. Enrolled subjects will be assessed for successful biliary drainage (primary outcome measure), adequate tissue diagnosis, adverse events, the need for additional procedures, hospitalizations, and oncological outcomes over a 6-month follow-up period. Subjects, treating clinicians and outcome assessors will not be blinded. Discussion The INTERCPT trial is designed to determine whether PTBD or ERC is the better initial approach when managing a patient with suspected MHO, a common clinical dilemma that has never been investigated in a randomized trial. Trial registration ClinicalTrials.gov, Identifier: NCT03172832. Registered on 1 June 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-2473-2) contains supplementary material, which is available to authorized users.
- Published
- 2018
4. Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial.
- Author
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Elmunzer, B. Joseph, Serrano, Jose, Chak, Amitabh, Edmundowicz, Steven A., Papachristou, Georgios I., Scheiman, James M., Singh, Vikesh K., Varadurajulu, Shyam, Vargo, John J., Willingham, Field F., Baron, Todd H., Coté, Gregory A., Romagnuolo, Joseph, Wood-Williams, April, Depue, Emily K., Spitzer, Rebecca L., Spino, Cathie, Foster, Lydia D., Durkalski, Valerie, and SVI study group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE)
- Subjects
PANCREATIC surgery ,INDOMETHACIN ,SURGICAL stents ,PANCREATITIS ,ENDOSCOPIC retrograde cholangiopancreatography ,RANDOMIZED controlled trials ,PREVENTION ,PANCREATITIS diagnosis ,COMBINED modality therapy ,COMPARATIVE studies ,EXPERIMENTAL design ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,NONSTEROIDAL anti-inflammatory agents ,RECTAL medication ,RESEARCH ,RISK assessment ,TIME ,TISSUE banks ,EVALUATION research ,TREATMENT effectiveness ,EQUIPMENT & supplies - Abstract
Background: The combination of prophylactic pancreatic stent placement (PSP) - a temporary plastic stent placed in the pancreatic duct - and rectal non-steroidal anti-inflammatory drugs (NSAIDs) is recommended for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. Preliminary data, however, suggest that PSP may be unnecessary if rectal NSAIDs are administered. Given the costs and potential risks of PSP, we aim to determine whether rectal indomethacin obviates the need for pancreatic stent placement in patients undergoing high-risk ERCP.Methods/design: The SVI (Stent vs. Indomethacin) trial is a comparative effectiveness, multicenter, randomized, double-blind, non-inferiority study of rectal indomethacin alone versus the combination of rectal indomethacin and PSP for preventing PEP in high-risk cases. One thousand four hundred and thirty subjects undergoing high-risk ERCP, in whom PSP is planned solely for PEP prevention, will be randomized to indomethacin alone or combination therapy. Those who are aware of study group assignment, including the endoscopist, will not be involved in the post-procedure care of the patient for at least 48 hours. Subjects will be assessed for PEP and its severity by a panel of independent and blinded adjudicators. Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups. Biological specimens will be obtained from trial participants and centrally banked.Discussion: The SVI trial is designed to determine whether PSP remains necessary in the era of NSAIDs pharmacoprevention. The associated bio-repository will establish the groundwork for important scientific breakthrough.Trial Registration: NCT02476279, registered June 2015. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
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5. Correction to: Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial.
- Author
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Elmunzer, B. Joseph, Serrano, Jose, Chak, Amitabh, Edmundowicz, Steven A., Papachristou, Georgios I., Scheiman, James M., Singh, Vikesh K., Varadarajulu, Shyam, Vargo, John J., Willingham, Field F., Baron, Todd H., Coté, Gregory A., Romagnuolo, Joseph, Wood-Williams, April, Depue, Emily K., Spitzer, Rebecca L., Spino, Cathie, Foster, Lydia D., Durkalski, Valerie, and SVI study group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE)
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RANDOMIZED controlled trials ,INDOMETHACIN - Abstract
An amendment to this paper has been published and can be accessed via the original article. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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6. Overcoming the barriers to better evidence generation from clinical trials.
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Kehoe L, Locke T, McClellan M, Landray M, Hernandez A, and Okun S
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- Humans, United States, Research Design, Evidence-Based Medicine standards, Patient Selection, Clinical Trials as Topic methods
- Abstract
Clinical evidence generation from and for representative populations can be improved through increased research access and ease of trial participation. To improve access and participation, a modern trial infrastructure is needed that broadens research into more routine practice. This commentary highlights current barriers, areas of advancement, and actions needed to enable continued transformation toward a modern trial infrastructure for an improved evidence generation system. The focus of this commentary is on the development of medical products (e.g., drugs, devices, biologics) and infrastructure issues within the United States, with the aim to have broader, multi-national applicability., (© 2024. The Author(s).)
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- 2024
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7. SMSs as an alternative to provider-delivered care for unhealthy alcohol use: study protocol for Leseli, an open-label randomised controlled trial of mhGAP-Remote vs mhGAP-Standard in Lesotho.
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Belus JM, Johnson NE, Yoon GH, Tschumi N, Lerotholi M, Falgas-Bague I, Lee TT, Letsoela P, Magidson JF, Amstutz A, and Labhardt ND
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- Humans, Lesotho, Male, Alcohol Drinking adverse effects, Alcohol Drinking prevention & control, Female, Randomized Controlled Trials as Topic, Adult, Multicenter Studies as Topic, Treatment Outcome, Alcoholism therapy, Middle Aged, Time Factors, Text Messaging, Motivational Interviewing
- Abstract
Background: The World Health Organization's (WHO) Mental Health Gap Action Programme (mhGAP) is a validated intervention that can be provided by non-specialised healthcare workers to individuals with unhealthy alcohol use. However, it typically requires several in-person sessions at a health facility, which may limit its feasibility and effectiveness in remote settings. This trial compares mhGAP-Standard, a 4 to 6 in-person session intervention, to mhGAP-Remote, a 1 in-person session intervention followed by 8 week of short message service (SMS) in Lesotho. We hypothesise that mhGAP-Remote is superior to mhGAP-Standard in reducing alcohol use (as detailed by the primary and secondary outcomes below)., Methods: This is a two-arm randomised open-label multicentre superiority trial. Participants allocated to mhGAP-Standard receive 4 in-person sessions using motivational interviewing, identifying triggers, and alternative behaviours, with the option of two additional booster sessions. Participants in the mhGAP-Remote arm receive 1 in-person session covering the same content, followed by standardised SMSs over 8 weeks that reinforce intervention content. Non-specialist providers deliver the intervention and receive weekly supervision. Adults (N
planned = 248) attending participating health facilities for any reason and who meet criteria for unhealthy alcohol use based on the Alcohol Use Disorders Identification Test ([AUDIT] score ≥ 6 for women, ≥ 8 for men) are individually randomised to the two arms (1:1 allocation, stratified by participant sex and age (≥ 50 vs < 50 years old). Follow-up assessments occur at 8, 20, and 32 weeks post-randomisation. The primary outcome is change in self-reported alcohol use (continuous AUDIT score), from baseline to 8 weeks follow-up. Change in the AUDIT from baseline to 20 and 32 weeks follow-up is a secondary outcome. Change in the biomarker phosphatidylethanol (secondary), liver enzyme values in serum (exploratory), and HIV viral load (for people with HIV only; exploratory) are also evaluated from baseline throughout the entire follow-up period. A linear regression model will be conducted for the primary analysis, adjusted for the stratification factors. Three a priori sensitivity analyses for the primary outcome are planned based on per protocol treatment attendance, recovery from unhealthy alcohol use, and clinically significant and reliable change., Discussion: This trial will provide insight into feasibility and effectiveness of a shortened and primarily SMS supported version of mhGAP, which is especially relevant for settings where regular clinic attendance is a major barrier., Trial Registration: clinicaltrials.gov NCT05925270 . Approved on June 29th, 2023., (© 2024. The Author(s).)- Published
- 2024
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8. Correction: Can flash glucose monitoring improve glucose management for Aboriginal and Torres Strait Islander peoples with type 2 diabetes? A protocol for a randomised controlled trial.
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Hachem M, Hearn T, Kelly R, Eer A, Moore B, Sommerville C, Atkinson-Briggs S, Twigg S, Freund M, O'Neal D, Story D, Brown A, McLean A, Sinha A, Furler J, O'Brien R, Tran-Duy A, Clarke P, Braat S, Koye DN, Eades S, Burchill L, and Ekinci E
- Published
- 2024
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9. Can flash glucose monitoring improve glucose management for Aboriginal and Torres Strait Islander peoples with type 2 diabetes? A protocol for a randomised controlled trial.
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Hachem M, Hearn T, Kelly R, Eer A, Moore B, Sommerville C, Atkinson-Briggs S, Twigg S, Freund M, O'Neal D, Story D, Brown A, McLean A, Sinha A, Furler J, O'Brien R, Tran-Duy A, Clarke P, Braat S, Koye DN, Eades S, Burchill L, and Ekinci E
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- Adult, Humans, Australia, Australian Aboriginal and Torres Strait Islander Peoples, Biomarkers blood, Glycemic Control, Hypoglycemia blood, Hypoglycemia prevention & control, Hypoglycemic Agents therapeutic use, Quality of Life, Randomized Controlled Trials as Topic, Time Factors, Treatment Outcome, Blood Glucose metabolism, Blood Glucose Self-Monitoring, Cost-Benefit Analysis, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 ethnology, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 therapy, Glycated Hemoglobin metabolism, Glycated Hemoglobin analysis
- Abstract
Background: Aboriginal and Torres Strait Islander peoples are disproportionately impacted by type 2 diabetes. Continuous glucose monitoring (CGM) technology (such as Abbott Freestyle Libre 2, previously referred to as Flash Glucose Monitoring) offers real-time glucose monitoring that is convenient and easy to use compared to self-monitoring of blood glucose (SMBG). However, this technology's use is neither widespread nor subsidised for Aboriginal and Torres Strait Islander peoples with type 2 diabetes. Building on existing collaborations with a national network of Aboriginal and Torres Strait Islander communities, this randomised controlled trial aims to assess the effect of CGM compared to SMBG on (i) haemoglobin A1c (HbA1c), (ii) achieving blood glucose targets, (iii) reducing hypoglycaemic episodes and (iv) cost-effective healthcare in an Aboriginal and Torres Strait Islander people health setting., Methods: This is a non-masked, parallel-group, two-arm, individually randomised, controlled trial (ACTRN12621000753853). Aboriginal and Torres Strait Islander adults with type 2 diabetes on injectable therapy and HbA1c ≥ 7.5% (n = 350) will be randomised (1:1) to CGM or SMBG for 6 months. The primary outcome is change in HbA1c level from baseline to 6 months. Secondary outcomes include (i) CGM-derived metrics, (ii) frequency of hypoglycaemic episodes, (iii) health-related quality of life and (iv) incremental cost per quality-adjusted life year gained associated with the CGM compared to SMBG. Clinical trial sites include Aboriginal Community Controlled Organisations, Aboriginal Medical Services, primary care centres and tertiary hospitals across urban, rural, regional and remote Australia., Discussion: The trial will assess the effect of CGM compared to SMBG on HbA1c for Aboriginal and Torres Strait Islander people with type 2 diabetes in Australia. This trial could have long-term benefits in improving diabetes management and providing evidence for funding of CGM in this population., Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12621000753853. Registered on 15th June 2021., (© 2024. The Author(s).)
- Published
- 2024
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10. 4-Aminopyridine treatment for nerve injury resulting from radical retro-pubic prostatectomy: a single-center double-blind, randomized, placebo-controlled study.
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Ghazi A, Osinski TL, Feng C, Horne A, and Elfar J
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- Humans, Male, Middle Aged, Double-Blind Method, Postoperative Complications etiology, Recovery of Function, Treatment Outcome, Erectile Dysfunction etiology, Erectile Dysfunction drug therapy, Peripheral Nerve Injuries etiology, Peripheral Nerve Injuries drug therapy, Prostatectomy adverse effects, Prostatectomy methods, Prostatic Neoplasms surgery, Urinary Incontinence etiology
- Abstract
Background: Prostate cancer (PCa) is the most common non-cutaneous malignancy in men and leads to the second most common cause of cancer related mortality in men. Early detection of PCa allows for a potentially curative intervention. Most men will live over a decade from the time of their PCa diagnosis. Thus, treatments must balance curative interventions with their impact on quality of life. Radical prostatectomy (RP) is one such potentially curative intervention but often leads to erectile dysfunction (ED) and urinary incontinence (UI). Approximately 90,000 RPs are performed each year in the USA. Post-operative ED and UI is thought to occur in part from traumatic peripheral nerve injury (TPNI) to the neurovascular bundles that surround the prostate. Thus, patients undergoing RP may be a population that would benefit from clinical studies that look at TPNI., Methods: The study is a single-institution, double-blinded placebo-controlled, randomized clinical trial in which patients immediately post-RP receive either 4-aminopyrdine (4AP) or placebo in a 1:1 fashion. The primary outcome is evaluation of the efficacy of 4AP in accelerating the early return of baseline erectile and urinary function post-radical prostatectomy., Discussion: This study is critical as it could reduce the morbidity associated with RP, a commonly performed operation, and identify a patient population that may greatly benefit into further TPNI research., Trial Registration: ClinicalTrials.gov NCT03701581. Prospectively registered on October 10, 2018., (© 2024. The Author(s).)
- Published
- 2024
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11. Adherence and acceptability of multiple micronutrient supplementation during pregnancy: Study protocol for a cluster-randomized non-inferiority trial in Cambodia.
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Hoang MA, Kroeun H, Klemm R, Gupta AS, Rem N, Meng S, Prak S, Rattana K, Chea M, Karakochuk CD, Sauer C, Mishra A, Mohan D, and de-Graffenried MJ
- Subjects
- Adult, Female, Humans, Pregnancy, Cambodia, Equivalence Trials as Topic, Iron administration & dosage, Medication Adherence, Multicenter Studies as Topic, Patient Acceptance of Health Care, Prenatal Care methods, Prospective Studies, Treatment Outcome, Randomized Controlled Trials as Topic, Dietary Supplements, Folic Acid administration & dosage, Micronutrients administration & dosage
- Abstract
Background: Iron and folic acid (IFA) supplements are currently provided to Cambodian women during pregnancy. However, recent research has found benefits of a multiple micronutrient supplement (MMS) over just IFA alone on several outcomes of perinatal and infant health. The Ministry of Health in Cambodia has proposed a transition from IFA to MMS but to effectively guide this transition requires implementation research on the acceptability and adherence to MMS (over IFA)., Methods: This non-inferiority trial aims to assess the adherence and acceptability of IFA (60 mg elemental iron and 400 μg folic acid) compared to MMS (standard UNIMMAP formulation including 15 micronutrients) during antenatal care in Cambodia. A prospective cohort of 1545 pregnant women will be assigned to one of three trial arms: (1) IFA for 90 days [IFA-90]; (2) MMS for 180 days with two distributions of 90-count tablet bottles [MMS-90]; or (3) MMS for 180 days with one 180-count tablet bottle [MMS-180]. Each arm will enroll 515 women across 48 health centers (clusters) in Kampong Thom Province in Cambodia. The primary outcome is the non-inferiority of adherence rates of MMS-180 compared to IFA-90, as assessed by tablet counts. Mixed-effects logistic and linear regression models will be used to estimate the difference in the adherence rate between the two groups, with an 'a priori' determined non-inferiority margin of 15%. Acceptability of MMS and IFA will be measured using a quantitative survey conducted with enrolled pregnant women at 30-day, 90-day, and 180-day time-points., Discussion: Findings from this study will guide an effective and feasible MMS scale-up strategy for Cambodia. Additionally, the findings will be shared globally with other stakeholders planning to scale up MMS in other countries., Trial Registration: NCT05867836 ( ClinicalTrials.gov , registered May 18, 2023)., (© 2024. The Author(s).)
- Published
- 2024
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12. OnTrack Chile for people with early psychosis: a study protocol for a Hybrid Type 1 trial.
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Mascayano F, Bello I, Andrews H, Arancibia D, Arratia T, Burrone MS, Conover S, Fader K, Jorquera MJ, Gomez M, Malverde S, Martínez-Alés G, Ramírez J, Reginatto G, Restrepo-Henao A, Rosencheck RA, Schilling S, Smith TE, Soto-Brandt G, Tapia E, Tapia T, Velasco P, Wall MM, Yang LH, Cabassa LJ, Susser E, Dixon L, and Alvarado R
- Subjects
- Adolescent, Adult, Chile, Humans, Randomized Controlled Trials as Topic, Young Adult, COVID-19, Psychotic Disorders diagnosis, Psychotic Disorders psychology, Psychotic Disorders therapy
- Abstract
Background: Substantial data from high-income countries support early interventions in the form of evidence-based Coordinated Specialty Care (CSC) for people experiencing First Episode Psychosis (FEP) to ameliorate symptoms and minimize disability. Chile is unique among Latin American countries in providing universal access to FEP services through a national FEP policy that mandates the identification of FEP individuals in primary care and guarantees delivery of community-based FEP treatments within a public health care system. Nonetheless, previous research has documented that FEP services currently provided at mental health clinics do not provide evidence-based approaches. This proposal aims to address this shortfall by first adapting OnTrackNY (OTNY), a CSC program currently being implemented across the USA, into OnTrackChile (OTCH), and then examine its effectiveness and implementation in Chile., Methods: The Dynamic Adaptation Process will be used first to inform the adaptation and implementation of OTCH to the Chilean context. Then, a Hybrid Type 1 trial design will test its effectiveness and cost and evaluate its implementation using a cluster-randomized controlled trial (RCT) (N = 300 from 21 outpatient clinics). The OTCH program will be offered in half of these outpatient clinics to individuals ages 15-35. Usual care services will continue to be offered at the other clinics. Given the current COVID-19 pandemic, most research and intervention procedures will be conducted remotely. The study will engage participants over the course of 2 years, with assessments administered at enrollment, 12 months, and 24 months. Primary outcomes include implementation (fidelity, acceptability, and uptake) and service outcomes (person-centeredness, adherence, and retention). Secondary outcomes comprise participant-level outcomes such as symptoms, functioning, and recovery orientation. Over the course of the study, interviews and focus groups with stakeholders will be conducted to better understand the implementation of OTCH., Discussion: Findings from this study will help determine the feasibility, effectiveness, and cost for delivering CSC services in Chile. Lessons learned about facilitators and barriers related to the implementation of the model could help inform the approach needed for these services to be further expanded throughout Latin America., Trial Registration: www., Clinicaltrials: gov NCT04247711 . Registered 30 January 2020., Trial Status: The OTCH trial is currently recruiting participants. Recruitment started on March 1, 2021, and is expected to be completed by December 1, 2022. This is the first version of this protocol (5/12/2021)., (© 2022. The Author(s).)
- Published
- 2022
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13. PRACT: a pragmatic randomized adaptive clinical trial protocol to investigate a culturally adapted brief negotiational intervention for alcohol use in the emergency department in Tanzania.
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Staton CA, Zadey S, O'Leary P, Phillips A, Minja L, Swahn MH, Hirshon JM, Boshe J, Sakita F, Vissoci JRN, and Mmbaga BT
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- Adolescent, Adult, Emergency Service, Hospital, Humans, Outcome Assessment, Health Care, Randomized Controlled Trials as Topic, Research Design, Tanzania, Text Messaging
- Abstract
Background: Alcohol use in resource-limited settings results in significant morbidity and mortality. These settings lack the necessary specialty-trained personnel and infrastructure. Therefore, implementing evidence-based interventions from high-income settings, like a brief negotiational intervention (BNI) for alcohol, will require rapid production of evidence of effectiveness to guide implementation priorities. Thus, this study describes a clinical trial protocol to rapidly optimize and evaluate the impact of a culturally adapted BNI to reduce alcohol-related harms and alcohol consumption among injury patients., Methods: Our pragmatic, adaptive, randomized controlled trial (PRACT) is designed to determine the most effective intervention approach to reduce hazardous alcohol use among adult (≥18 years old) in acute (< 24 h) injury patients. Our culturally adapted, nurse-delivered, intervention (PPKAY) has been augmented with evidence-based, culturally appropriate standards and will be evaluated as follows. Stage 1 of the trial will determine if PPKAY, either with a standard short-message-service (SMS) booster or with a personalized SMS booster is more effective than usual care (UC). While optimizing statistical efficiency, Stage 2 drops the UC arm to compare the PPKAY with a standard SMS booster to PPKAY with a personalized SMS booster. Finally, in Stage 3, the more effective arm in Stage 2 is compared to PPKAY without an SMS booster. The study population is acute injury patients who present to Kilimanjaro Christian Medical Centre, Tanzania, who (1) test alcohol positive by breathalyzer upon arrival; (2) have an Alcohol Use Disorder Identification Test of 8 or above; and/or (3) have reported drinking alcohol prior to their injury. Outcome measures will be evaluated for all arms at 3, 6, 9, 12, and 24 months. The primary outcome for the study is the reduction of the number of binge drinking days in the 4 weeks prior to follow-up. Secondary outcomes include alcohol-related consequences, measured by the Drinker Inventory of Consequences., Discussion: The findings from this study will be critically important to identify alcohol harm reduction strategies where alcohol research and interventions are scarce. Our innovative and adaptive trial design can transform behavior change research and identify the most effective nurse-driven intervention to be targeted for integration into standard care., Trial Registration: ClinicalTrials.gov NCT04535011 . Registered on September 1, 2020., (© 2022. The Author(s).)
- Published
- 2022
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14. Natural tannin extracts supplementation for COVID-19 patients (TanCOVID): a structured summary of a study protocol for a randomized controlled trial.
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Molino S, Pisarevsky A, Mingorance FL, Vega P, Stefanolo JP, Repetti J, Ludueña G, Pepa P, Olmos JI, Fermepin MR, Uehara T, Villapol S, Savidge T, Treangen T, Viciani E, Castagnetti A, and Piskorz MM
- Subjects
- Adolescent, Adult, Argentina, Dietary Supplements, Female, Humans, Lactation, Plant Extracts adverse effects, Pregnancy, Prospective Studies, RNA, Viral, Randomized Controlled Trials as Topic, SARS-CoV-2, Tannins adverse effects, Treatment Outcome, COVID-19
- Abstract
Objectives: This research aims to study the efficacy of tannins co-supplementation on disease duration, severity and clinical symptoms, microbiota composition and inflammatory mediators in SARS-CoV2 patients., Trial Design: This is a prospective, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the efficacy of the administration of the dietary supplement ARBOX, a molecular blend of quebracho and chestnut tannins extract and Vit B12, in patients affected by COVID-19., Participants: 18 years of age or older, admitted to Hospital de Clinicas Jose de San Martin, Buenos Aires University (Argentina), meeting the definition of "COVID-19 confirmed case" ( https://www.argentina.gob.ar/salud/coronavirus-COVID-19/definicion-de-caso ). Inclusion Criteria Participants are eligible to be included in the study if the following criteria apply: 1. Any gender 2. ≥18 years old 3. Informed consent for participation in the study 4. Virological diagnosis of SARS-CoV-2 infection (real-time PCR) Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: 1. Pregnant and lactating patients 2. Patients who cannot take oral therapy (with severe cognitive decline, assisted ventilation, or impaired consciousness) 3. Hypersensitivity to polyphenols 4. Patients already in ICU or requiring mechanical ventilation 5. Patients already enrolled in other clinical trials 6. Decline of consent INTERVENTION AND COMPARATOR: Experimental: TREATED ARM Participants will receive a supply of 28 -- 390 mg ARBOX capsules for 14 days. Patients will be supplemented with 2 capsules of ARBOX per day. Placebo Comparator: CONTROL ARM Participants will receive placebo supply for 14 days. The placebo will be administered with the identical dose as described for the test product. All trial participants will receive standard therapy, which includes: Antipyretics or Lopinavir / Ritonavir, Azithromycin and Hydroxychloroquine, as appropriate (treatment currently recommended by the department of Infectious Diseases of the Hospital de Clínicas that could undergo to modifications). In addition, if necessary: supplemental O2, non-invasive ventilation, antibiotic therapy., Main Outcomes: Primary Outcome Measures: Time to hospital discharge, defined as the time from first dose of ARBOX to hospital discharge [ Time Frame: Throughout the Study (Day 0 to Day 28) ] Secondary Outcome Measures: 28-day all-cause mortality [ Time Frame: Throughout the Study (Day 0 to Day 28) ]-proportion Invasive ventilation on day 28 [ Time Frame: Throughout the Study (Day 0 to Day 28) ]-proportion Level of inflammation parameters and cytokines [ Time Frame: day 1-14 ] -mean difference Difference in fecal intestinal microbiota composition and intestinal permeability [ Time Frame: day 1-14 ] Negativization of COVID-PCR at day 14 [ Time Frame: day 14 ]-proportion RANDOMIZATION: Potential study participants were screened for eligibility 24 hours prior to study randomization. Patients were randomly assigned via computer-generated random numbering (1:1) to receive standard treatment coupled with tannin or standard treatment plus placebo (control group)., Blinding (masking): Study personnel and participants are blinded to the treatment allocation, as both ARBOX and placebo were packed in identical containers. Thus, all the used capsules had identical appearance., Numbers to Be Randomized (sample Size): Considering an alpha error of 5%, a power of 80% a sample size of 70 patients per branch was estimated. 140 patients in total., Trial Status: The protocol version is number V2, dated May 23, 2020. The first patient, first visit was on June 12, 2020; the recruitment end date was October 6, 2020. The protocol was not submitted earlier because the enrollment of some patients took place after the closure of the recruitment on the clinicaltrials platform. In fact, due to the epidemiological conditions, due to the decrease of the cases in Argentina during the summer period, the recruitment stopped t before reaching the number of 140 patients (as indicated in the webpage). However, since there was a new increase in cases, the enrolment was resumed in order to reach the number of patients initially planned in the protocol. The final participant was recruited on February 14, 2021., Trial Registration: ClinicalTrials.gov, number: NCT04403646 , registered on May 27th, 2020., 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 has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
- Published
- 2021
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15. A randomized clinical trial of a theory-based fentanyl overdose education and fentanyl test strip distribution intervention to reduce rates of opioid overdose: study protocol for a randomized controlled trial.
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Jacka BP, Goldman JE, Yedinak JL, Bernstein E, Hadland SE, Buxton JA, Sherman SG, Biello KB, and Marshall BDL
- Subjects
- Adolescent, Adult, Aged, Analgesics, Opioid adverse effects, Humans, Middle Aged, North America, Randomized Controlled Trials as Topic, Rhode Island, Young Adult, Fentanyl adverse effects, Opiate Overdose drug therapy, Opiate Overdose prevention & control
- Abstract
Background: Opioid overdose deaths involving synthetic opioids, particularly illicitly manufactured fentanyl, remain a substantial public health concern in North America. Responses to overdose events (e.g., administration of naloxone and rescue breathing) are effective at reducing mortality; however, more interventions are needed to prevent overdoses involving illicitly manufactured fentanyl. This study protocol aims to evaluate the effectiveness of a behavior change intervention that incorporates individual counseling, practical training in fentanyl test strip use, and distribution of fentanyl test strips for take-home use among people who use drugs., Methods: Residents of Rhode Island aged 18-65 years who report recent substance use (including prescription pills obtained from the street; heroin, powder cocaine, crack cocaine, methamphetamine; or any drug by injection) (n = 500) will be recruited through advertisements and targeted street-based outreach into a two-arm randomized clinical trial with 12 months of post-randomization follow-up. Eligible participants will be randomized (1:1) to receive either the RAPIDS intervention (i.e., fentanyl-specific overdose education, behavior change motivational interviewing (MI) sessions focused on using fentanyl test strips to reduce overdose risk, fentanyl test strip training, and distribution of fentanyl test strips for personal use) or standard overdose education as control. Participants will attend MI booster sessions (intervention) or attention-matched control sessions at 1, 2, and 3 months post-randomization. All participants will be offered naloxone at enrolment. The primary outcome is a composite measure of self-reported overdose in the previous month at 6- and/or 12-month follow-up visit. Secondary outcome measures include administratively linked data regarding fatal (post-mortem investigation) and non-fatal (hospitalization or emergency medical service utilization) overdoses., Discussion: If the RAPIDS intervention is found to be effective, its brief MI and fentanyl test strip training components could be easily incorporated into existing community-based overdose prevention programming to help reduce the rates of fentanyl-related opioid overdose., Trial Registration: ClinicalTrials.gov NCT04372238 . Registered on 01 May 2020.
- Published
- 2020
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16. 'Mothers moving towards empowerment' intervention to reduce stigma and improve treatment adherence in pregnant women living with HIV in Botswana: study protocol for a pragmatic clinical trial.
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Poku OB, Ho-Foster AR, Entaile P, Misra S, Mehta H, Rampa S, Goodman M, Arscott-Mills T, Eschliman E, Jackson V, Melese T, Becker TD, Eisenberg M, Link B, Go V, Opondo PR, Blank MB, and Yang LH
- Subjects
- Botswana, Child, Female, Humans, Infant, Infant, Newborn, Infectious Disease Transmission, Vertical prevention & control, Mothers, Pregnancy, Pregnant Women, Randomized Controlled Trials as Topic, Treatment Adherence and Compliance, Anti-HIV Agents therapeutic use, HIV Infections diagnosis, HIV Infections drug therapy
- Abstract
Background: With high rates of HIV and multiple vulnerable subgroups across diverse settings, there is a need for culturally based, HIV stigma reduction interventions. Pregnant women who are living with HIV are especially in need of services to protect not only their own but also their children's lives. Uptake of HIV services worldwide is hindered by stigma towards persons living with HIV/AIDS. While cultural context plays a key role in shaping HIV stigma, these insights have not yet been fully integrated into stigma reduction strategies. By utilizing the "What Matters Most" stigma framework, we propose that an intervention to counter culturally salient aspects of HIV stigma will improve treatment adherence and other relevant outcomes. A pragmatic clinical trial in Botswana will evaluate the "Mothers Moving towards Empowerment" (MME) intervention, which seeks to address HIV stigma in Botswana and to specifically engage pregnant mothers so as to promote antiretroviral therapy (ART) adherence in the postpartum period., Methods: This study will test MME against treatment as usual (TAU) among pregnant mothers diagnosed with HIV and their infants. Outcomes will be assessed during pregnancy and 16 weeks postpartum. Women who meet eligibility criteria are assigned to MME or TAU. Women assigned to MME are grouped with others with similar estimated delivery dates, completing up to eight intervention group sessions scheduled before week 36 of their pregnancies. Primary outcomes among mothers include (i) reducing self-stigma, which is hypothesized to mediate improvements in (ii) psychological outcomes (quality of life, depression and social functioning), and (iii) adherence to antenatal care and ART. We will also examine a set of follow-up infant birth outcomes (APGAR score, preterm delivery, mortality (at < 16 weeks), birth weight, vaccination record, and HIV status)., Discussion: Our trial will evaluate MME, a culturally based HIV stigma reduction intervention using the "What Matters Most" framework, to reduce stigma and improve treatment adherence among pregnant women and their infants. This study will help inform further refinement of MME and preparation for a future large-scale, multisite, randomized controlled trial (RCT) in Botswana., Trial Registration: ClinicalTrials.gov NCT03698981 . Registered on October 8, 2018.
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- 2020
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17. Problem solving therapy (PST) tailored for intimate partner violence (IPV) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia: protocol for a randomised controlled feasibility trial.
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Keynejad RC, Bitew T, Sorsdahl K, Myers B, Honikman S, Medhin G, Deyessa N, Sevdalis N, Tol WA, Howard L, and Hanlon C
- Subjects
- Anxiety psychology, Depression psychology, Ethiopia, Feasibility Studies, Female, Humans, Pregnancy, Problem Solving, Quality of Life, Randomized Controlled Trials as Topic, Rural Population, Stress Disorders, Post-Traumatic psychology, Anxiety therapy, Depression therapy, Intimate Partner Violence psychology, Psychotherapy methods, Stress Disorders, Post-Traumatic therapy
- Abstract
Background: In rural Ethiopia, 72% of women are exposed to lifetime intimate partner violence (IPV); IPV is most prevalent during pregnancy. As well as adversely affecting women's physical and mental health, IPV also increases the risk of child morbidity and mortality associated with maternal depression, thus making antenatal care an important opportunity for intervention. Adapting generic, task-shared, brief psychological interventions for perinatal depression and anxiety to address the needs and experiences of women affected by IPV may improve acceptability to women and feasibility for health workers. This randomised controlled feasibility trial will compare brief problem solving therapy (PST) specifically adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care to determine the feasibility of a future fully powered randomised controlled trial., Methods: Seventy-five pregnant women scoring five or more on the Patient Health Questionnaire, endorsing a tenth question about functional impact and reporting past-year IPV, will be recruited from antenatal care clinics in predominantly rural districts in Ethiopia. Consenting participants will be randomised to either four sessions of PST-IPV, four sessions of standard PST or information about sources of support (enhanced usual care) in a three-arm design. The interventions will be delivered by trained, supervised antenatal care staff using a task-sharing model. Assessments will be made at baseline and after 9 weeks by masked outcome assessors and will include measures of depression symptoms (primary outcome), post-traumatic stress, anxiety symptoms, functional impact, past-month IPV and hypothesised mediators (secondary outcomes). A mixed-method process evaluation will determine the feasibility of a future randomised controlled trial, assess the feasibility, acceptability, fidelity and quality of implementation of PST-IPV, generate testable hypotheses about causal mechanisms, and identify potential contextual factors influencing outcomes., Discussion: Despite mental health being a critical concern for women experiencing IPV, there is limited evidence for brief, task-shared psychological interventions adapted for their needs in low- and middle-income countries. Contextually tailored interventions for pregnant women experiencing IPV in low- and middle-income countries require development and process evaluation. This randomised controlled feasibility trial will yield results on the feasibility of conducting a fully powered trial, relevant to researchers, primary and antenatal care clinicians in resource-limited settings., Trial Registration: Pan-African clinical trials registry: PACTR202002513482084. Prospectively registered on 13 December 2019.
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- 2020
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18. Intense versus standard regimens of intermittent occlusion therapy for unilateral moderate amblyopia in children: study protocol for a randomized controlled trial.
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Wang J, Malik A, Jin J, Pang Y, Yin K, Allen M, Grigorian A, Scombordi B, Bailey J, Aljohani S, Funari K, Shoge R, Meiyeppen S, Myung J, Soni A, and Neely DE
- Subjects
- Child, Humans, Monitoring, Physiologic, Randomized Controlled Trials as Topic, Treatment Outcome, Visual Acuity, Amblyopia therapy, Liquid Crystals, Sensory Deprivation
- Abstract
Background: We reported that in our previous study that wearing intermittent occlusion therapy glasses (IO-therapy) for 4 hours (h) was non-inferior to patching for 2 h in 3 to 8-year-old children with amblyopia. We hypothesize that an intense regimen of 12-h IO-therapy per day for 4 weeks could be as effective as the standard regimen of 4-h IO-therapy per day for 12 weeks in treating moderate amblyopia in 3 to 8-year-old children., Methods/design: A total of 56 children between 3 and 8 years of age with amblyopia in association with anisometropia and/or strabismus will be enrolled. All participants will be prescribed IO-therapy glasses (Amblyz™), set at 30-s opaque/transparent intervals (i.e., occluded 50% of wear time). They will be randomized to receive the standard regimen for 12 weeks or the intense regimen for 4 weeks. Adherence to using the IO-therapy glasses will be objectively monitored in each participant by means of a microsensor dose monitor. The primary study objective is to compare the effectiveness of an intense regimen to a standard regimen of IO-therapy in 3 to 8-year-old children with moderate amblyopia. The secondary study objectives are to determine whether adherence differs between an intense regimen and a standard regimen of IO-therapy, and to determine the dose-response relationship of IO-therapy., Discussion: In addition to testing the effectiveness, this study will test for the first time the association between treatment adherence and the visual outcome of IO-therapy, which will enhance our understanding of the dose-response relationship of IO-therapy. If an intense regimen is shown to be effective, it would alter amblyopia treatment strategies and improve visual outcomes., Trial Registration: ClinicalTrials.gov: NCT02767856. Registered on 10 May 2016.
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- 2020
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19. Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey.
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Katiri R, Hall DA, Buggy N, Hogan N, Horobin A, van de Heyning P, Firszt JB, Bruce IA, and Kitterick PT
- Subjects
- Cochlear Implants, Deafness physiopathology, Delphi Technique, Hearing Loss, Unilateral physiopathology, Humans, Noise, Observational Studies as Topic, Prospective Studies, Quality of Life, Research Design, Surveys and Questionnaires, Tinnitus, Treatment Outcome, Cochlear Implantation methods, Consensus, Deafness rehabilitation, Hearing Aids, Hearing Loss, Unilateral rehabilitation, Speech Perception
- Abstract
Background: Single-sided deafness (SSD) describes the presence of a unilateral severe to profound sensorineural hearing loss. SSD disrupts spatial hearing and understanding speech in background noise. It has functional, psychological and social consequences. Potential options for rehabilitation include hearing aids and auditory implants. Benefits and harms of these interventions are documented inconsistently in the literature, using a variety of outcomes ranging from tests of speech perception to quality of life questionnaires. It is therefore difficult to compare interventions when rehabilitating SSD. The Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study is an international initiative that aims to develop a minimum set of core outcomes for use in future trials of SSD interventions., Methods/design: The CROSSSD study adopts an international two-round online modified Delphi survey followed by a stakeholder consensus meeting to identify a patient-centred core outcome domain set for SSD based on what is considered critical and important for assessing whether an intervention for SSD has worked., Discussion: The resulting core outcome domain set will act as a minimum standard for reporting in future clinical trials and could have further applications in guiding the use of outcome measures in clinical practice. Standardisation will facilitate comparison of research findings.
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- 2020
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20. Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials.
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Doua YJ, Dominicus H, Mugwagwa J, Gombe SM, and Nwokike J
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- Drugs, Investigational therapeutic use, Humans, Clinical Trials as Topic, Documentation, Drug Approval, Product Surveillance, Postmarketing, Quality Assurance, Health Care, Registries
- Abstract
Background: This research reviewed major Clinical Trial Registries (CTRs) and assessed the availability of fields on quality assurance for approved medicines used as Investigational Medicinal Products (IMPs) in phase IV clinical trials., Methods: Two reviewers independently assessed CTRs of the International Committee of Medical Journal Editors (ICJME) and of World Health Organization (WHO) platforms. Each CTR was checked by two reviewers on availability of fields on brand name, manufacturer's name, approval status, approving authority, compliance with Good Manufacturing Practices, and quality testing. In case of discrepancy, consensus was sought between the two reviewers., Results: Of 19 identified CTRs, 8 and 6 belonged to WHO and ICMJE, respectively, while 5 were equally part of both platforms. All CTRs had an 'intervention' field where data on IMPs and IMP comparators are captured. The Canadian CTR used 'drug name' rather than 'intervention'. The EU, Peruvian, and UK CTRs had fields for 'brand name'. However, only the EU CTR had fields for 'manufacturer's name', 'approval status', and 'approving authority'. None of the CTRs had fields on 'compliance with Good Manufacturing Practices' or 'quality testing'., Conclusion: This study demonstrates that none of the CTRs of ICMJE and WHO platforms has adequate fields to establish that the source of post-marketing IMPs is of assured quality. This is astonishing given the lengthy requirements in WHO and ICMJE guidelines. Considering the relation between IMP quality and safety of clinical trial participants, the gap of quality assurance fields should be bridged at CTRs concurrently to adjustments of WHO and ICMJE guidelines on CTRs. Specifically, IMP quality testing addressing issues on IMP appearance, impurities, microbial contamination, and dosing should be conducted and reported before, during, and after clinical trial conduct. Until adoption of these measures, the EU CTR should be preferred for registration of phase IV clinical trials conducted in countries lacking stringent regulatory capacities.
- Published
- 2019
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21. The effectiveness and cost-effectiveness of 3- vs. 6-monthly dispensing of antiretroviral treatment (ART) for stable HIV patients in community ART-refill groups in Zimbabwe: study protocol for a pragmatic, cluster-randomized trial.
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Fatti G, Ngorima-Mabhena N, Chirowa F, Chirwa B, Takarinda K, Tafuma TA, Mahachi N, Chikodzore R, Nyadundu S, Ajayi CA, Mutasa-Apollo T, Mugurungi O, Mothibi E, Hoffman RM, and Grimwood A
- Subjects
- Anti-HIV Agents administration & dosage, Comparative Effectiveness Research, Cost-Benefit Analysis, Drug Prescriptions economics, Equivalence Trials as Topic, HIV Infections diagnosis, HIV Infections virology, Humans, Pragmatic Clinical Trials as Topic, Time Factors, Treatment Outcome, Viral Load, Zimbabwe, Anti-HIV Agents economics, Anti-HIV Agents supply & distribution, Community Pharmacy Services economics, Drug Costs, HIV Infections drug therapy, HIV Infections economics
- Abstract
Background: Sub-Saharan Africa is the world region with the greatest number of people eligible to receive antiretroviral treatment (ART). Less frequent dispensing of ART and community-based ART-delivery models are potential strategies to reduce the load on overburdened healthcare facilities and reduce the barriers for patients to access treatment. However, no large-scale trials have been conducted investigating patient outcomes or evaluating the cost-effectiveness of extended ART-dispensing intervals within community ART-delivery models. This trial will assess the clinical effectiveness, cost-effectiveness and acceptability of providing ART refills on a 3 vs. a 6-monthly basis within community ART-refill groups (CARGs) for stable patients in Zimbabwe., Methods: In this pragmatic, three-arm, parallel, unblinded, cluster-randomized non-inferiority trial, 30 clusters (healthcare facilities and associated CARGs) are allocated using stratified randomization in a 1:1:1 ratio to either (1) ART refills supplied 3-monthly from the health facility (control arm), (2) ART refills supplied 3-monthly within CARGs, or (3) ART refills supplied 6-monthly within CARGs. A CARG consists of 6-12 stable patients who meet in the community to receive ART refills and who provide support to one another. Stable adult ART patients with a baseline viral load < 1000 copies/ml will be invited to participate (1920 participants per arm). The primary outcome is the proportion of participants alive and retained in care 12 months after enrollment. Secondary outcomes (measured at 12 and 24 months) are the proportions achieving virological suppression, average provider cost per participant, provider cost per participant retained, cost per participant retained with virological suppression, and average patient-level costs to access treatment. Qualitative research will assess the acceptability of extended ART-dispensing intervals within CARGs to both providers and patients, and indicators of potential facility-level decongestion due to the interventions will be assessed., Discussion: Cost-effective health system models that sustain high levels of patient retention are urgently needed to accommodate the large numbers of stable ART patients in sub-Saharan Africa. This will be the first trial to evaluate extended ART-dispensing intervals within a community-based ART distribution model, and results are intended to inform national and regional policy regarding their potential benefits to both the healthcare system and patients., Trial Registration: ClinicalTrials.gov, ID: NCT03238846 . Registered on 27 July 2017.
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- 2018
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22. Erratum to: 'Early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (The ELAIN-Trial): study protocol for a randomized controlled trial'.
- Author
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Zarbock A, Gerß J, Van Aken H, Boanta A, Kellum JA, and Meersch M
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- 2016
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23. Standardised outcomes in nephrology - Haemodialysis (SONG-HD): study protocol for establishing a core outcome set in haemodialysis.
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Tong A, Manns B, Hemmelgarn B, Wheeler DC, Tugwell P, Winkelmayer WC, van Biesen W, Crowe S, Kerr PG, Polkinghorne KR, Howard K, Pollock C, Hawley CM, Johnson DW, McDonald SP, Gallagher MP, Urquhart-Secord R, and Craig JC
- Subjects
- Consensus, Consensus Development Conferences as Topic, Delphi Technique, Humans, Renal Insufficiency, Chronic diagnosis, Renal Insufficiency, Chronic physiopathology, Systematic Reviews as Topic, Treatment Outcome, Clinical Trials as Topic standards, Nephrology standards, Renal Dialysis standards, Renal Insufficiency, Chronic therapy, Research Design standards
- Abstract
Background: Chronic kidney disease is a significant contributor to mortality and morbidity worldwide, and the number of people who require dialysis or transplantation continues to increase. People on dialysis are 15 times more likely to die than the general population. Dialysis is also costly, intrusive, and time-consuming and imposes an enormous burden on patients and their families. This escalating problem has spurred a proliferation of trials in dialysis, yet health and quality of life remain poor. The reasons for this are complex and varied but are attributable in part to problems in the design and reporting of studies, particularly outcome selection. Problems related to outcomes include use of unvalidated surrogates, outcomes of little or no relevance to patients, highly variable outcome selection limiting comparability across studies, and bias in reporting outcomes. The aim of the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) study is to establish a core outcome set for haemodialysis trials, to improve the quality of reporting, and the relevance of trials conducted in people on haemodialysis., Methods/design: SONG-HD is a five-phase project that includes the following: a systematic review to identify outcomes that have been reported in haemodialysis systematic reviews and trials; nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choices; qualitative stakeholder interviews with patients, caregivers, clinicians, researchers, and policy makers to elicit individual values and perspectives on outcomes for haemodialysis trials; a three-round Delphi survey with stakeholder groups to distil and generate a prioritised list of core outcomes; and a consensus workshop to establish a core outcome set for haemodialysis trials., Discussion: Establishing a core outcome set to be consistently measured and reported in haemodialysis trials will improve the integrity, transparency, usability, and contribution of research relevant to patients requiring haemodialysis; ensure that outcomes of relevance to all stakeholders are consistently reported across trials; and mitigate against outcome reporting bias. Ultimately, patients will be more protected from potential harm, patients and clinicians will be better able to make informed decisions about treatment, and researchers and policy makers will be more able to maximise the value of research to the public.
- Published
- 2015
- Full Text
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