IU Indianapolis ScholarWorks :: Browsing by Subject "Protocol"

Browsing by Subject "Protocol"

Now showing 1 - 9 of 9

Effects of etching duration on the surface roughness, surface loss, flexural strength, and shear bond strength to a resin cement of e.max cad glass ceramic
(2017) Al-Johani, Hanan; Chu, Tien-Min Gabriel; Platt, Jeffrey A.; Cook, Norman B.; Bottino, Marco C.
Background: Long-term retention of ceramic restorations is dependent on the bond strength of the luting resin to both the tooth and porcelain substrates. In order to achieve successful bonding, the surface of the porcelain substrate must be modified to increase the surface roughness, and this can be achieved chemically by hydrofluoric (HF) acid etching. However, prolonged HF acid etching has shown to have a weakening effect on the evaluated lithium disilicate glass-ceramics. Therefore, it is essential to quantify the required etching duration of HF acid to minimize the possible deleterious effects on ceramic strength while maximizing the bond strength to tooth structure. Objectives: To evaluate the effects of HF acid etching duration on the surface roughness, surface loss, flexural strength, and shear bond strength of IPS e.max CAD (Ivoclar Vivadent) lithium disilicate-based glass ceramic to a resin cement. Hypothesis: The differences in HF acid etching durations will not have a significant effect on the surface roughness, surface loss, flexural strength, or shear bond strength of IPS e.max CAD to a resin cement. Methods: 168 specimens were prepared from IPS e.max CAD blocks. All specimens were polished and sonically cleaned in distilled water. Specimens were fired in the vacuum pump furnace according to the manufacturer’s instructions. Specimens were then divided into 4 groups, according to etching durations, then further divided into 3 subgroups, according to the properties tested. Group A was not etched (control), Groups B, C and D were etched with 5-percent HF acid (IPS Ceramic Etching gel, Ivoclar Vivadent) for 20 s, 60 s and 90 s respectively. The morphologies of both etched and non-etched surfaces in specimens of subgroup 1 of each etching group (n = 16/group) were observed under scanning electron microscopy (SEM). In addition, non-contact surface profilometry (Proscan 2000) was used to calculate the surface loss and to examine the surface roughness of the etched ceramic surfaces and roughness values (Ra, Rq) were documented for each group. Furthermore, etched specimens of subgroup 2 (n = 16/group) were silanated (Monobond Plus, Ivoclar Vivadent) and cemented with a resin cement (Multilink Automix, Ivoclar Vivadent). The shear bond strength (SBS) was measured using a universal mechanical testing machine. For each etching group, subgroup 3 specimens (n = 10/group) were loaded to failure in a three-point bending test to measure their flexural strength values using a universal mechanical testing machine. Data for surface roughness, surface loss, and flexural strength were analyzed using one-way analysis of variance (ANOVA), to identify the significant effects of different HF acid etching durations. Data for shear bond strength test were analyzed using two-way ANOVA to test the effects of etching duration, storage for 24 hours/thermocycling, and their interaction. All pair-wise comparisons from ANOVA analysis were made using Fisher’s Protected Least Significant Differences to control the overall significance level at 5 percent. Results: Difference in HF etching durations did not have a significant effect on surface roughness values Ra or Rq (p = 0.3408; p = 0.3245) respectively, but had a significant effect on surface loss (p = 0.0006). SBS values were not significantly different between experimental groups (p = 0.4650); however, SBS values after 24-h storage were significantly higher than that found after thermocycling (p = 0.0166) among different etching durations. Finally, different HF etching durations did not have a significant effect on flexural strength values (p = 0.1260). Conclusion: Within the limitations of this study, different HF etching durations did not have a significant effect on surface roughness, flexural strength, or shear bond strength of IPS e.max CAD. However, the different etching durations significantly affected the surface loss of the lithium disilicate glass ceramics.
Examining the Efficacy of the Telehealth Assessment and Skill-Building Kit (TASK III) Intervention for Stroke Caregivers: Protocol for a Randomized Controlled Clinical Trial
(JMIR, 2025-03-25) Bakas, Tamilyn; Miller, Elaine; Sucharew, Heidi; Kreitzer, Natalie; Israel, Jahmeel; Rota, Matthew; Harnett, Brett; Dunning, Kari; Jones, Holly; McCarthy, Michael; Brehm, Bonnie; Austin, Joan K.; Mitchell, Pamela H.; School of Nursing
Background: Stroke is a leading cause of serious, long-term disability and has a sudden onset. Upon discharge to the home setting, families are thrust into providing care, often without sufficient training from health care providers. Aligned with current patient and caregiver guidelines, the Telehealth Assessment and Skill-Building Kit (TASK III) is a nurse-led intervention designed to empower caregivers to address their own needs and those of the survivor using innovative skill-building strategies. Objective: This study aims to test the short-term (immediately after the intervention at 8 wk) and long-term (12, 24, and 52 wk) efficacy of the TASK III intervention, compared with an information, support, and referral (ISR) group, to improve caregiver life changes (ie, changes in physical health, physical functioning, emotional well-being, and general health) as a result of providing care. Methods: A randomized controlled clinical trial design will be used with baseline data collection from 296 family caregivers by telephone after the stroke survivor is discharged home. Caregivers randomly assigned to the ISR group (n=148, 50%) will receive information from the American Heart Association about stroke family caregiving. Caregivers randomly assigned to the TASK III group (n=148, 50%) will receive a TASK III resource guide and information from the American Heart Association. Both groups will receive 8 weekly calls from a nurse, with a booster call a month later. Outcomes will be assessed by blinded data collectors at 8, 12, 24, and 52 weeks. The primary outcome (at 8 wk) is caregiver life changes measured by the Bakas Caregiving Outcomes Scale. Secondary outcomes are depressive symptoms; other symptoms (eg, stress, fatigue, sleep, pain, and shortness of breath); unhealthy days; diet; exercise; and self-reported health care use. Mediators are task difficulty, threat appraisal, and self-efficacy. Program evaluation outcomes (satisfaction and technology ratings) will also be analyzed. Results: The trial was registered on March 10, 2022. Enrollment and random assignment of the first participant was on November 30, 2022, with an anticipated completion of recruitment by November 30, 2025. Completion of the primary end point data analysis is anticipated by August 31, 2026, with results expected to be reported on ClinicalTrials.gov by April 1, 2027. As of October 9, 2024, a total of 198 (66.9% of the proposed total sample of 296) family caregivers have been enrolled and randomly assigned to the TASK III group (n=98, 49.5%) or the ISR group (n=100, 50.5%). The last update was performed on January 25, 2024. Conclusions: If the TASK III intervention is shown to be efficacious in the proposed randomized controlled clinical trial, our next goal will be to translate TASK III into ongoing stroke systems of care, providing a tremendous public health impact.
Guidance for biostatisticians on their essential contributions to clinical and translational research protocol review
(Cambridge University Press, 2021-07-12) Ciolino, Jody D.; Spino, Cathie; Ambrosius, Walter T.; Khalatbari, Shokoufeh; Messinger Cayetano, Shari; Lapidus, Jodi A.; Nietert, Paul J.; Oster, Robert A.; Perkins, Susan M.; Pollock, Brad H.; Pomann, Gina-Maria; Price, Lori Lyn; Rice, Todd W.; Tosteson, Tor D.; Lindsell, Christopher J.; Spratt, Heidi; Biostatistics and Health Data Science, School of Medicine
Rigorous scientific review of research protocols is critical to making funding decisions, and to the protection of both human and non-human research participants. Given the increasing complexity of research designs and data analysis methods, quantitative experts, such as biostatisticians, play an essential role in evaluating the rigor and reproducibility of proposed methods. However, there is a common misconception that a statistician’s input is relevant only to sample size/power and statistical analysis sections of a protocol. The comprehensive nature of a biostatistical review coupled with limited guidance on key components of protocol review motived this work. Members of the Biostatistics, Epidemiology, and Research Design Special Interest Group of the Association for Clinical and Translational Science used a consensus approach to identify the elements of research protocols that a biostatistician should consider in a review, and provide specific guidance on how each element should be reviewed. We present the resulting review framework as an educational tool and guideline for biostatisticians navigating review boards and panels. We briefly describe the approach to developing the framework, and we provide a comprehensive checklist and guidance on review of each protocol element. We posit that the biostatistical reviewer, through their breadth of engagement across multiple disciplines and experience with a range of research designs, can and should contribute significantly beyond review of the statistical analysis plan and sample size justification. Through careful scientific review, we hope to prevent excess resource expenditure and risk to humans and animals on poorly planned studies.
Malaria chemoprevention with monthly dihydroartemisinin-piperaquine for the post-discharge management of severe anaemia in children aged less than 5 years in Uganda and Kenya: study protocol for a multi-centre, two-arm, randomised, placebo-controlled, superiority trial
(BMC, 2018-11-06) Kwambai, Titus K.; Dhabangi, Aggrey; Idro, Richard; Opoka, Robert; Kariuki, Simon; Samuels, Aaron M.; Desai, Meghna; van Hensbroek, Michael Boele; John, Chandy C.; Robberstad, Bjarne; Wang, Duolao; Phiri, Kamija; Ter Kuile, Feiko O.; Pediatrics, School of Medicine
BACKGROUND: Children hospitalised with severe anaemia in malaria endemic areas in Africa are at high risk of readmission or death within 6 months post-discharge. Currently, no strategy specifically addresses this period. In Malawi, 3 months of post-discharge malaria chemoprevention (PMC) with monthly treatment courses of artemether-lumefantrine given at discharge and at 1 and 2 months prevented 30% of all-cause readmissions by 6 months post-discharge. Another efficacy trial is needed before a policy of malaria chemoprevention can be considered for the post-discharge management of severe anaemia in children under 5 years of age living in malaria endemic areas. OBJECTIVE: We aim to determine if 3 months of PMC with monthly 3-day treatment courses of dihydroartemisinin-piperaquine is safe and superior to a single 3-day treatment course with artemether-lumefantrine provided as part of standard in-hospital care in reducing all-cause readmissions and deaths (composite primary endpoint) by 6 months in the post-discharge management of children less than 5 years of age admitted with severe anaemia of any or undetermined cause. METHODS/DESIGN: This is a multi-centre, two-arm, placebo-controlled, individually randomised trial in children under 5 years of age recently discharged following management for severe anaemia. Children in both arms will receive standard in-hospital care for severe anaemia and a 3-day course of artemether-lumefantrine at discharge. At 2 weeks after discharge, surviving children will be randomised to receive either 3-day courses of dihydroartemisinin-piperaquine at 2, 6 and 10 weeks or an identical placebo and followed for 26 weeks through passive case detection. The trial will be conducted in hospitals in malaria endemic areas in Kenya and Uganda. The study is designed to detect a 25% reduction in the incidence of all-cause readmissions or death (composite primary outcome) from 1152 to 864 per 1000 child years (power 80%, α = 0.05) and requires 520 children per arm (1040 total children). RESULTS: Participant recruitment started in May 2016 and is ongoing.
A management algorithm for patients with intracranial pressure monitoring: the Seattle International Severe Traumatic Brain Injury Consensus Conference (SIBICC)
(Springer, 2019-12-01) Hawryluk, Gregory W. J.; Aguilera, Sergio; Buki, Andras; Bulger, Eileen; Citerio, Giuseppe; Cooper, D. Jamie; Arrastia, Ramon Diaz; Diringer, Michael; Figaji, Anthony; Gao, Guoyi; Geocadin, Romergryko; Ghajar, Jamshid; Harris, Odette; Hoffer, Alan; Hutchinson, Peter; Joseph, Mathew; Kitagawa, Ryan; Manley, Geoffrey; Mayer, Stephan; Menon, David K.; Meyfroidt, Geert; Michael, Daniel B.; Oddo, Mauro; Okonkwo, David; Patel, Mayur; Robertson, Claudia; Rosenfeld, Jeffrey V.; Rubiano, Andres M.; Sahuquillo, Juan; Servadei, Franco; Shutter, Lori; Stein, Deborah; Stocchetti, Nino; Taccone, Fabio Silvio; Timmons, Shelly; Tsai, Eve; Ullman, Jamie S.; Vespa, Paul; Videtta, Walter; Wright, David W.; Zammit, Christopher; Chesnut, Randall M.; Neurological Surgery, School of Medicine
Background Management algorithms for adult severe traumatic brain injury (sTBI) were omitted in later editions of the Brain Trauma Foundation’s sTBI Management Guidelines, as they were not evidence-based. Methods We used a Delphi-method-based consensus approach to address management of sTBI patients undergoing intracranial pressure (ICP) monitoring. Forty-two experienced, clinically active sTBI specialists from six continents comprised the panel. Eight surveys iterated queries and comments. An in-person meeting included whole- and small-group discussions and blinded voting. Consensus required 80% agreement. We developed heatmaps based on a traffic-light model where panelists’ decision tendencies were the focus of recommendations. Results We provide comprehensive algorithms for ICP-monitor-based adult sTBI management. Consensus established 18 interventions as fundamental and ten treatments not to be used. We provide a three-tier algorithm for treating elevated ICP. Treatments within a tier are considered empirically equivalent. Higher tiers involve higher risk therapies. Tiers 1, 2, and 3 include 10, 4, and 3 interventions, respectively. We include inter-tier considerations, and recommendations for critical neuroworsening to assist the recognition and treatment of declining patients. Novel elements include guidance for autoregulation-based ICP treatment based on MAP Challenge results, and two heatmaps to guide (1) ICP-monitor removal and (2) consideration of sedation holidays for neurological examination. Conclusions Our modern and comprehensive sTBI-management protocol is designed to assist clinicians managing sTBI patients monitored with ICP-monitors alone. Consensus-based (class III evidence), it provides management recommendations based on combined expert opinion. It reflects neither a standard-of-care nor a substitute for thoughtful individualized management.
Pharmacokinetic Characterization of Labetalol in Pregnancy (The CLIP Study): A Prospective Observational Longitudinal Pharmacokinetic/Pharmacodynamic Cohort Study During Pregnancy and Postpartum
(MDPI, 2025-04-18) Bhamidipaty-Pelosi, Surya; Muralidharan, Suhaas; Yeley, Brittany C.; Haas, David M.; Quinney, Sara K.; Medicine, School of Medicine
Background/Objectives: Hypertensive disorders of pregnancy are a leading cause of pregnancy-related deaths in the United States, accounting for 7% of maternal mortality. Labetalol and nifedipine are the first-line drugs for the management of hypertension in pregnancy, but there are little data guiding the choice of one drug over the other. The current pilot longitudinal study aims to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of labetalol stereoisomers throughout pregnancy and postpartum. Methods: This is a single-center clinical study recruiting up to 40 pregnant individuals ≥ 18 years of age at the time of enrollment, taking labetalol as per the standard of care. The exclusion criteria include any pathophysiology impacting the PK of labetalol, e.g., liver failure. Maternal plasma, urine, amniotic fluid, cord blood, and breast milk will be collected, and labetalol stereoisomers will be measured using a validated LC-MS/MS assay. Heart rate and blood pressure will be measured as the PD endpoints. These may be assessed throughout a participant's dosing interval at scheduled PK study visits, which will occur every 6-10 weeks during pregnancy, at delivery, during the 1st week postpartum, and up to 20 weeks postpartum. The primary aim is to characterize the PK and PD of labetalol during pregnancy and in the postpartum period. The secondary aim is to determine the extent of breast milk excretion of and infant exposure to labetalol from breast milk. The data will be analyzed using population PK modeling to evaluate the PK/PD relationship and ultimately develop trimester-specific dosing recommendations. Results/Conclusions: To our knowledge, this is the first study aiming to characterize the PK of labetalol stereoisomers across pregnancy and postpartum, utilizing individual stereoisomer data to evaluate the PK/PD relationship, and collecting postpartum samples, including breast milk, to model infant exposure to labetalol through breast milk. This study will provide important PK/PD data and knowledge which will be combined with large multi-center clinical trial data to develop trimester-specific dosing regimens for anti-hypertensive agents.
PROTOCOL: Guidance for stakeholder engagement in guideline development: A systematic review
(Wiley, 2022-05-11) Petkovic, Jennifer; Riddle, Alison; Lytvyn, Lyubov; Khabsa, Joanne; Akl, Elie A.; Welch, Vivian; Magwood, Olivia; Atwere, Pearl; Graham, Ian D.; Grant, Sean; John, Denny; Vittal Katikireddi, Srinivasa; Langlois, Etienne; Mustafa, Reem A.; Todhunter‐Brown, Alex; Schünemann, Holger; Smith, Maureen; Stein, Airton T.; Concannon, Tom; Tugwell, Peter; Epidemiology, Richard M. Fairbanks School of Public Health
This is the protocol for a Campbell systematic review. The objectives are as follows: to identify, describe, and summarize existing guidance and methods for multistakeholder engagement throughout the health guideline development process.
A Randomized Placebo-Controlled Trial of Bupropion for Cancer-Related Fatigue: Study Design and Procedures
(Elsevier, 2020-04) Jim, Heather S.L.; Hoogland, Aasha I.; Han, Hyo Sook; Culakova, Eva; Heckler, Charles; Janelsins, Michelle; Williams, Geoffrey C.; Bower, Julienne; Cole, Stephen; Desta, Zeruesenay; Bobonis Babilonia, Margarita; Morrow, Gary; Peppone, Luke; Medicine, School of Medicine
Background: Cancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue. Methods: A randomized, double-blind, placebo-controlled trial will examine the effects of bupropion on cancer-related fatigue. The trial will be conducted nationwide through the University of Rochester Medical Center (URMC) National Cancer Institute Community Oncology Research Program (NCORP). Disease-free breast cancer survivors (n = 422) who completed chemotherapy and/or radiotherapy 12-60 months previously and report significant fatigue will be randomized 1:1 to receive bupropion (300 mg/day) or placebo. Outcomes will be assessed at baseline and the 12-week follow-up. The primary outcome, fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). Secondary outcomes include quality of life, depression, and drug tolerability. Exploratory outcomes include cognition and symptomatology. Potential biological mechanisms and genetic moderators of cancer-related fatigue will also be explored. Discussion: This study is the first placebo-controlled trial to our knowledge to evaluate bupropion for cancer-related fatigue. Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.
Wheeled mobility use outcomes: a systematic review protocol of measurement properties
(Wolters Kluwer, 2024-09) Mendoza, Kiera; Loeser, Madison; Ouellet, Béatrice; Best, Krista L.; Paula, Rushton W.; Kenyon, Lisa K.; Hinrichs, Rachel J.; Chase, Tony
Numerous tools have been developed to measure constructs related to wheelchair use. Currently, no toolkit comprehensively details assessments of wheeled mobility device use based on the quality of their measurement properties. The current review aims to systematically identify high-quality assessment tools that measure different aspects of wheeled mobility use. The objectives are two-fold: i) to synthesize outcome measures that assess use of wheeled mobility devices, and ii) to evaluate measurement properties of the assessment tools. The populations of interest are manual wheelchair users, power wheelchair users, and scooter users of any age, diagnosis, or setting. Instruments of any type will be included. The JBI methodology for systematic reviews of measurement properties will guide this review. A search strategy will be developed to search the following databases: MEDLINE (Ovid), Embase, CINAHL (EBSCOhost), PsycINFO (EBSCOhost), PsycTests (EBSCOhost), Web of Science, and Google Scholar. The article selection process, data extraction, and quality appraisal will be performed by 2 independent reviewers, with a third reviewer being consulted to achieve consensus. The methodological quality of the studies will be assessed through the Consensus Standards for the Selection of Measurement Instruments (COSMIN) Risk of Bias tool and the COSMIN Checklist. The quality of the pooled evidence and individual measurement properties will be graded using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach and the COSMIN Criteria for Good Measurement Properties recommendations. Measurement properties of each instrument will be described, with the goal of developing a toolkit that identifies appropriate assessment tools for wheeled mobility use outcomes.

Browsing by Subject "Protocol"

Results Per Page

Sort Options