Dataset Information

Comparing Efficacy and Safety of Empirical vs. Guided Therapy for Non-cardiac Chest Pain: A Pragmatic Randomized Trial.

ABSTRACT: Background: Non-cardiac chest pain is common with two-thirds due to gastroesophageal reflux disease (GERD). Objective: To evaluate the effectiveness and safety of guided vs. empirical therapy in non-cardiac chest pain. Methods: Adults with normal angiogram or stress test were randomized into either a guided or empirical group. In the guided group, after the ambulatory pH-impedance test, if GERD then dexlansoprazole 30 mg/day for 8 weeks, but if functional or hypersensitive chest pain, then theophylline SR 250 mg/day for 4 weeks. In the empirical group, dexlansoprazole 60 mg/day was given for 2 weeks. The primary outcome was global chest pain visual analog score (VAS) and secondary outcomes were Quality of Life in Reflux and Dyspepsia (QOLRAD), GERD questionnaire (GERDQ), and pH parameters, all determined at baseline, 2nd and 8th weeks. Results: Of 200 screened patients, 132 were excluded, and of 68 randomized per-protocol, 33 were in the guided group and 35 in the empirical group. For between-group analysis, mean global pain scores were better with guided vs. empirical group at 8th week (P = 0.005) but not GERDQ or QOLRAD or any of pH measures (all P > 0.05). For within-group analysis, mean QOLRAD improved earliest at 8th week vs. baseline (P = 0.006) in the guided group and 2nd week vs. baseline (P = 0.011) in the empirical group but no differences were seen in other secondary outcomes (P > 0.05). No serious adverse events were reported. Conclusions: Guided approach may be preferred over short-term empirical therapy in symptom response, however QOLRAD, acid-related symptoms, or pH measures are not significantly different (trial registration ID no. NCT03319121).

SUBMITTER: Abdul Kadir NP

PROVIDER: S-EPMC7917139 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparing Efficacy and Safety of Empirical vs. Guided Therapy for Non-cardiac Chest Pain: A Pragmatic Randomized Trial.

Abdul Kadir Noor Purdah NP Ma Zheng Feei ZF Abdul Hafidz Muhammad Ilham MI Annamalai Chandramouli C Jayaraman Thevaraajan T Hamid Nurhazwani N Norhasliza Siti S Abd Aziz Azliani A Yusof Zurkurnai Z Lee Hady H Lee Yeong Yeh YY

Frontiers in medicine 20210215

Background: Non-cardiac chest pain is common with two-thirds due to gastroesophageal reflux disease (GERD). Objective: To evaluate the effectiveness and safety of guided vs. empirical therapy in non-cardiac chest pain. Methods: Adults with normal angiogram or stress test were randomized into either a guided or empirical group. In the guided group, after the ambulatory pH-impedance test, if GERD then dexlansoprazole 30 mg/day for 8 weeks, but if functional or hypersensitive c ...[more]

PMID: 33659261

Similar Datasets

Project description: To compare the effectiveness of shared decision making with usual care in choice of admission for observation and further cardiac testing or for referral for outpatient evaluation in patients with possible acute coronary syndrome. Multicenter pragmatic parallel randomized controlled trial. Six emergency departments in the United States. 898 adults (aged >17 years) with a primary complaint of chest pain who were being considered for admission to an observation unit for cardiac testing (451 were allocated to the decision aid and 447 to usual care), and 361 emergency clinicians (emergency physicians, nurse practitioners, and physician assistants) caring for patients with chest pain. Patients were randomly assigned (1:1) by an electronic, web based system to shared decision making facilitated by a decision aid or to usual care. The primary outcome, selected by patient and caregiver advisers, was patient knowledge of their risk for acute coronary syndrome and options for care; secondary outcomes were involvement in the decision to be admitted, proportion of patients admitted for cardiac testing, and the 30 day rate of major adverse cardiac events. Compared with the usual care arm, patients in the decision aid arm had greater knowledge of their risk for acute coronary syndrome and options for care (questions correct: decision aid, 4.2 v usual care, 3.6; mean difference 0.66, 95% confidence interval 0.46 to 0.86), were more involved in the decision (observing patient involvement scores: decision aid, 18.3 v usual care, 7.9; 10.3, 9.1 to 11.5), and less frequently decided with their clinician to be admitted for cardiac testing (decision aid, 37% v usual care, 52%; absolute difference 15%; P<0.001). There were no major adverse cardiac events due to the intervention. Use of a decision aid in patients at low risk for acute coronary syndrome increased patient knowledge about their risk, increased engagement, and safely decreased the rate of admission to an observation unit for cardiac testing.Trial registration ClinicalTrials.gov NCT01969240.

Project description:ImportanceThe incremental benefit of noninvasive testing in addition to clinical evaluation (history, physical examination, an electrocardiogram [ECG], and biomarker assessment) vs clinical evaluation alone for patients who present to the emergency department (ED) with acute chest pain is unknown.ObjectiveTo examine differences in outcomes with clinical evaluation and noninvasive testing (coronary computed tomographic angiography [CCTA] or stress testing) vs clinical evaluation alone.Design, setting, and participantsThis study was a retrospective analysis of data from the randomized multicenter Rule Out Myocardial Ischemia/Infarction by Computer Assisted Tomography (ROMICAT-II) trial. Data for 1000 patients who presented with chest pain to the EDs at 9 hospitals in the United States were evaluated.InterventionsClinical evaluation plus noninvasive testing (CCTA or stress test) vs clinical evaluation alone.Main outcomes and measuresPrimary outcome was length of stay (LOS). Secondary outcomes included hospital admission, direct ED discharge, downstream testing, rates of invasive coronary angiography, revascularization, major adverse cardiac events (MACE), repeated ED visit or hospitalization for recurrent chest pain at 28 days, and cost. Safety end points were missed acute coronary syndrome (ACS) and cumulative radiation exposure during the index visit and follow-up period.ResultsOf the 1000 patients randomized, 118 patients (12%) (mean [SD] age, 53.2 [7.8]; 49 [42%] were female) did not undergo noninvasive testing, whereas 882 (88%) (mean [SD] age, 54.4 [8.14] years; 419 [48%] were female) received CCTA or stress testing. There was no difference in baseline characteristics or clinical presentation between groups. Patients who underwent clinical evaluation alone experienced a shorter LOS (20.3 vs 27.9 hours; P < .001), lower rates of diagnostic testing (P < .001) and angiography (2% vs 11%; P < .001), lower median costs ($2261.50 vs $2584.30; P = .009), and less cumulative radiation exposure (0 vs 9.9 mSv; P < .001) during the 28-day study period. Lack of testing was associated with a lower rate of diagnosis of ACS (0% vs 9%; P < .001) and less coronary angiography and percutaneous coronary intervention (PCI) during the index visit (0% vs 10%; P < .001, and 0% vs 4%; P = .02, respectively). There was no difference in rates of PCI (2% vs 5%; P = .15), coronary artery bypass surgery (0% vs 1%; P = .61), return ED visits (5.8% vs 2.8%; P = .08), or MACE (2% vs 1%; P = .24) in the 28-day follow-up period.Conclusions and relevanceIn patients presenting to the ED with acute chest pain, negative biomarkers, and a nonischemic ECG result, noninvasive testing with CCTA or stress testing leads to longer LOS, more downstream testing, more radiation exposure, and greater cost without an improvement in clinical outcomes.Trial registrationclinicaltrials.gov Identifier: NCT01084239.

Project description:ImportanceProbation is a cornerstone of efforts to reduce mass incarceration. Although it is understudied, specialty probation could improve outcomes for the overrepresented group of people with mental illness.ObjectiveTo test whether specialty probation yields better public safety outcomes than traditional probation.Design, setting, and participantsA longitudinal observational study with group matching on age, sex, race/ethnicity, probation time, and offense at 2 urban agencies that exemplify specialty and traditional probation. Enrollment began October 19, 2005; follow-up data were complete January 26, 2013. Participants were 359 diverse probationers with serious mental health problems and functional impairment. Probationers and officers were assessed 3 times (for probationers, 6-month retention, 315 of 359 [88%]; 12-month retention 304 of 359 [85%]) and follow-up records were obtained. Machine learning algorithms were combined with a targeted maximum likelihood estimation, a double robust estimator that accounts for associations between confounders and both treatment assignment and outcomes. Statistical analysis was conducted from January 1, 2016 to May 5, 2017.InterventionsSpecialty probationers were assigned to small, homogeneous caseloads supervised by experts. Prior data indicate that specialty officers had better relationships with probationers, participated more in probationers' treatment, and relied more on positive compliance strategies than traditional officers.Main outcomes and measuresViolence during 1 year, determined by probationer report, officer report, and records, and rearrest during a period of 2 to 5 years, according to Federal Bureau of Investigation records.ResultsParticipants were 183 specialty (73.8% of 248 eligible) and 176 traditional (56.6% of 311 eligible) probationers (205 men and 154 women; mean [SD] age, 36.9 [10.6]). Although specialty probation had no significant effect on violence (odds ratio, 0.97; 95% CI, 0.69-1.36), the odds of rearrest were 2.68 times higher for traditional probationers than for specialty probationers (95% CI, 1.86-3.84; P?<?.001). At 2 years, estimated probabilities of rearrest were 28.6% for specialty probationers and 51.8% for traditional probationers. Survival analyses indicate that arrest effects endured up to 5 years.Conclusions and relevanceAlthough it did not specifically reduce violence, well-implemented specialty probation appears to be effective in reducing general recidivism. Reform efforts for people with mental illness could leverage probation-a ubiquitous and revitalized node of the justice system.

Dataset Information

Comparing Efficacy and Safety of Empirical vs. Guided Therapy for Non-cardiac Chest Pain: A Pragmatic Randomized Trial.

Publications

Comparing Efficacy and Safety of Empirical vs. Guided Therapy for Non-cardiac Chest Pain: A Pragmatic Randomized Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure