Study Population definition
Study Population. This includes a clear description of the populations impacted by each hypothesis, as well as the comparison population, if applicable. The discussion may include the sampling methodology for the selected population, as well as support that a statistically reliable sample size is available. Access, Service Delivery Improvement, Health Outcome, Satisfaction and Cost Measures: This includes identification, for each hypothesis, of quantitative and/or qualitative process and/or outcome measures that adequately assess the effectiveness of the Demonstration. Nationally recognized measures may be used where appropriate. Measures will be clearly stated and described, with the numerator and dominator clearly defined. To the extent possible, the State may incorporate comparisons to national data and/or measure sets. A broad set of performance metrics may be selected from nationally recognized metrics, for example from sets developed by the Center for Medicare and Medicaid Innovation, for meaningful use under HIT, and from the Medicaid Core Adult sets. Among considerations in selecting the metrics shall be opportunities identified by the State for improving quality of care and health outcomes, and controlling cost of care.
Study Population. A total of 4 healthy male volunteers between 18 and 65 years of age will be enrolled in the study. • Study Endpoints: Safety, pharmacokinetic profiling. •
Study Population. A multi-center, randomized, double-blind trial will involve a total of about 300 patients, aged 18 years and above, with chronic bacterial prostatitis. • Study Design: Patients will be randomized to receive either NM441 (600 mg qd) or levofloxacin (500 mg qd). Each subject will receive one capsule each morning. Laboratory assessments and clinical evaluations will be performed at screening and Days 21 and 42 of the 42-day study period. Microbiological assessment (the four-glass test) will be performed at screening and on Day 42. In addition, clinical evaluation and microbiological assessment will be performed on Day 70, four weeks after the final antibiotic dose. •
Examples of Study Population in a sentence
Data may still be missing for Study Population Members who either could not answer or chose not to answer a particular question.
Study Population The study population will be comprised of 183 study participants with severe heterogeneous emphysema as defined by the study eligibility criteria.
Some variables and/or categories may need to be eliminated or combined depending on the composition of Study Population Members.
All Study Population Members randomized into the Control Group will be included in the Control Group regardless of what services they receive from JVS or other agencies.
Results Study Population A total of 127 patients with LVEF ≤ 35% and moderate to severe functional MR underwent RMA (as a single procedure or with concomitant tricuspid valve annuloplasty, CSD implantation, or coronary artery bypass grafting) at the authors’ institution between 2006 and 2015.
Number and Location of Clinical Study Site(s) Up to 10 Sites in Australia Study Population Healthy adults 18 years or over who are receiving a licensed QIV vaccine Treatment Groups MVA-NP+M1 vs.
All Enrolled Participants and Study Population Members will be assigned a Unique Identifier that will be used in the Master Data File.
Methods Study Population Data for the study were requested from the Danish Breast Cancer Cooperative Group (DBCG).
Demographic Information of the Study Population by Dosing Method 20 Table 2.
Primary Objective: • To compare the safety and efficacy of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis Study Population: Male and female adult subjects who have plantar fasciitis that has not responded to conservative treatment modalities.
More Definitions of Study Population
Study Population. The sample consisted of two cohorts of adult patients transported by EMS to ▇▇▇▇▇ Memorial Hospital in Atlanta, GA between January 2011 and December 2012. Patients were excluded for cardiac arrest, trauma, toxic ingestion, pregnancy, or psychiatric emergency and were stratified into two groups at either high or low risk of sepsis. Patients whose EMS vitals included heart rate greater than 90 beats/min, respiratory rate greater than 20 breaths/min, and systolic blood pressure less than 110 mm Hg were considered high-risk; all else were low-risk. METHODS AND RESULTS: Thirty-one (27%) of high-risk patients and 12 (2.2%) of low- risk patients had sepsis (p-value <.0001), determined by inpatient diagnosis within 48 hours of hospital arrival. For both cohorts, patient vitals changed between the field and ED, though Glasgow Coma Scale scores did not change (p-values .42 and .81). We retrospectively screened patients with a modified version of PRESS in the field and qSOFA in the ED. Among high-risk patients, PRESS was 90% sensitive and 22% specific; in low- risk patients it was 83% sensitive and 17% specific. qSOFA was 41% sensitive and 88% specific in high-risk patients, and 17% sensitive and 98% specific in low-risk patients. Agreement between screening tools was low, but best for high-risk patients with sepsis (Kappa=0.15, p-value <.0001). Among patients misclassified by either tool, mean heart rate was the most common difference between those with and without sepsis. CONCLUSION: Further studies are needed to validate PRESS and qSOFA for emergency sepsis screening. PRESS is limited by low specificity, and qSOFA may be unreliable in patients transported by EMS due to low sensitivity.
Study Population. MLIU sub-populations identified in DSRIP performing provider systems (adults) Measure ▇▇▇▇▇▇▇ or Source AHRQ ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇▇.▇▇▇/Modules/PQI_Tech Spec_ICD10_v70.aspx Technical Specifications This measure was developed by the AHRQ. Performing providers will report the numerator and denominator necessary to calculate this adult composite measure: Numerator: Number of discharges for clients 18 years and older in DSRIP attributed target population for the provider system, that meet the inclusion and exclusion rules for the numerator in any of the following PQIs: • PQI #10 Dehydration Admission Rate • PQI #11 Bacterial Pneumonia Admission Rate • PQI #12 Urinary Tract Infection Admission Rate Discharges are only counted once in the numerator, even if they qualify for more than one PQI listed above. Denominator: DSRIP attributed target population for the provider system (18 years and older) Rate: (numerator / denominator) * 100 Exclusion Criteria Numerator excludes obstetric discharges, along with specific exclusion criteria listed in the PQI 10, 11, and 12 specifications Data Source(s)/ Data Collection Method(s) • DSRIP reporting: Provider reported rate • RHP plan update: Provider and RHP characteristics for HLM model • DSRIP administrative data: Provider and RHP characteristics for HLM model Comparison Group(s)/ Subgroup(s) • RHP subgroups Analytic Methods • Descriptive trend analysis o Paired t-test or ▇▇▇▇▇▇▇▇ signed-rank test • Hierarchical linear modeling or growth curve modeling, if feasible Benchmark • Baseline established CY17 • DY7 goal of 2.5% improvement over baseline • DY8 goal of 10% improvement over baseline *Selected Category C measure from the Measure Bundle Protocol (Texas Health and Human Services Commission, 2018).
Study Population. The study population consisted of all residents of the Vale do Rio Doce Data Sources and Methods: Data on newly detected cases of leprosy were retrieved from Aspatial analysis: Cases reported during the study period were aggregated by month and
Study Population. Key Exclusion Criteria (see Section 7.2 for a complete list): • Type 1 diabetes; • Congenital heart disease; clinically significant ECG abnormality; • Physical exam, ▇▇▇▇▇ ▇▇▇▇▇, or laboratory abnormality; clinically significant hepatic or renal disease; • Creatinine clearance (▇▇▇▇▇▇▇▇ formula) < 60 mL/minute; • Clinically significant thyroid dysfunction as evidenced by signs, symptoms, or TSH > 1.5 x ULN; • Obesity of known genetic or endocrine origin; • History of bipolar disorder or psychosis, greater than one lifetime episode of major depressive disorder, depression of moderate or greater severity, or presence or history of suicidal behavior or active suicidal ideation; • Recent weight instability, or prior bariatric surgery; • History of glaucoma or increased intraocular pressure; • Current smoker or smoking cessation within 3 months of screening; • Currently taking or plan on taking any of following medications during the study: o Anticonvulsants used for treatment of seizure disorder, including barbiturates, benzodiazepines, GABA analogues, hydantoins, phenyltriazines, succinimides, and other agents (valproic acid and its derivatives, carbamazepine and its derivatives, zonisamide, and felbamate); o Tricyclic antidepressants, MAOIs, lithium, levodopa, and dopamine receptor agonists; o Carbonic anhydrase inhibitors; o Insulin, SFUs, GLP-1 agonists, SGLT-1, and SGLT-2 inhibitors; o Chronic systemic steroids (i.e. glucocorticoids, anabolic steroids) other than oral contraceptives; o Treatment for hyperactivity disorder; or o OTC, prescription medications, herbal agents and dietary supplements used with the intention to lose body weight. Study Drug Form and Strength: • Low-dose (for titration purposes only): One PHEN/TPM 3.75/23 mg capsule administered daily • Mid-dose: One PHEN/TPM 7.5/46 mg capsule administered daily • ¾-dose (for titration purposes only): One PHEN/TPM 11.25/69 mg capsule administered daily • Top-dose: One PHEN/TPM 15/92 mg capsule administered daily Study drug will be packaged into 2 types of kits; titration kits (blister cards) for use during the first 4 weeks of dosing and the first 4 weeks following up-titration for subjects randomized to the top-dose (Weeks 13-16), and treatment kits (bottles), for use once subjects have been titrated to their assigned dosage. Regimen/Administration: Each capsule of study drug will be taken orally in the morning, with or without food, and with water.
Study Population. Patients with Type 1 or Type 2 diabetes suffering from painful distal symmetric sensorimotor polyneuropathy (painful DPN) present for ≥ 6 months who meet all inclusion and exclusion criteria are eligible to participate. Sample Size: The sample size for this study is planned to be approximately 274 evaluable patients, which provides a power of 0.8 for detecting a treatment difference of 0.8 points on the NRS. Assuming a pooled standard deviation of 2.35, this corresponds to a standardized effect size of approximately 0.34, an effect size comparable to effect sizes observed in recent diabetic neuropathic pain studies using efficacious agents such as duloxetine and pregabalin (▇▇▇▇▇ et al, 2018). An effect size of this magnitude or greater, if observed in this study, would support the further investigation of ricolinostat as a potential treatment for painful DPN.
Study Population. Primary HLH patients • Patients can be naïve to HLH treatment (first line patients), or may have already received conventional HLH therapy (second line patients) without having obtained a satisfactory response according to the treating physician or having shown signs of intolerance to it. • Patients who receive NI-0501 as second line treatment for HLH will represent the pivotal cohort of the study.