Introduction to Nonrandomized Trial

STUDY SELECTION Randomized controlled trials (RCTs), nonrandomized trials, and cohort studies of observed physical activity (at least 10 sessions on 10 days) in participants with MS, CP, and SCI.

RESULTS The analysis included 51 studies (46 observational studies, one nonrandomized trial, and four randomized controlled trials) comprising 2361 patients.

We conducted a literature search of systematic reviews of randomized controlled and nonrandomized trials published between 2018 and 2019 that multiple physicians had reviewed independently.

From the larger database of nonrandomized trials, we listed adverse events in specific organs/sites among patients with cancer who are treated with photons and protons to identify critical issues.

Quality appraisal analyses were performed for each study using the Cochrane Collaboration tools for randomized and nonrandomized trials.

PURPOSE Many immune checkpoint inhibitors (ICIs) have been approved on the basis of tumor response end points in nonrandomized trials, including objective response rate (ORR) and duration and depth of response.

Four nonrandomized trials, 3 laboratory studies, 1 single-case experiment, and 1 RCT were identified.

Methods A single-arm, nonrandomized trial was performed to evaluate a digital DSMES program that includes remote monitoring and lifestyle change, in addition to comprehensive diabetes education staffed by a diabetes specialist.

RECENT FINDINGS Multiple randomized and nonrandomized trials have compared commercial and investigational TAVR valves.

Design, Setting, and Participants A single-center, phase 2 nonrandomized trial enrolled patients from August 17, 2016, to June 5, 2018.

Data Synthesis  A systematic literature search on randomized clinical trials (RCTs), nonrandomized trials and other systematic reviews was performed.

Randomized controlled trials (RCTs) and nonrandomized trials that involved using a technological medium e.

Methods The SPARC intervention is being evaluated through the EMERALD (Enabling Mobilization, Empowerment, Risk Reduction, and Lasting Dignity) study, which consists of a prospective 2-group comparative nonrandomized trial (n=385), a cross-sectional survey (n=100), and in-depth interviews assessing SPARC implementation (n=45).

We included 5 observational studies and 3 nonrandomized trials reporting clinical outcomes of 140 CGH patients after GONBs.

Multiple randomized and nonrandomized trials and registries have demonstrated the safety and effectiveness of LAAO in patients who are suitable for short-term anticoagulation using a variety of post-procedural antithrombotic strategies.

METHODS  We searched MEDLINE, EMBASE, and Cochrane Central for randomized controlled trials, nonrandomized trials, and quasi-experimental studies which evaluated CDS tools that were developed for inpatient pharmacists as a target user.

RESULTS There were 84 articles [23 randomized controlled trials (RCTs), 21 nonrandomized trials, 8 observational studies, and 32 in vitro studies] included.

Method In this single-blinded, nonrandomized trial, 82 participants completed all aspects of the study.

Included studies focused on youth; had study design of randomized controlled trial (RCT), nonrandomized trial, or case review (n > 10); and included an outcome measure of treatment effectiveness.

Materials and Methods: In this single-center prospective nonrandomized trial, a total of 62 patients who underwent CEA (c-CEA, n = 31; e-CEA, n = 31) for symptomatic ipsilateral ICA stenosis ≥50% between January 2018 and December 2019 were included.

In a phase II nonrandomized trial, we previously reported that prophylactic irradiation to the contralateral breast among BRCA carriers undergoing breast-conserving treatment significantly reduced subsequent contralateral breast cancer.

The independent Newcastle Ottawa scale was used to conduct methodological quality assessment of nonrandomized trials.

Fast, efficient, reliable, and practice-relevant evaluation of digital health applications is not achieved by turning to nonrandomized trials, but rather by better pragmatic randomized trials.

Predefined criteria were used to select randomized controlled trials, quasiexperimental nonrandomized trials, and cohort studies that addressed the benefits and harms of observed physical activity (at least 10 sessions on 10 different days of movement using more energy than rest) in participants with multiple sclerosis, cerebral palsy, and spinal cord injury.

LIMITATIONS: The analysis was based on nonrandomized trials with a moderate risk of bias.

This study evaluated both randomized and nonrandomized trials of battlefield acupuncture for the treatment of both acute and chronic pain.

CONCLUSIONS In this nonrandomized trial, sitagliptin in combination with tacrolimus and sirolimus resulted in a low incidence of grade II to IV acute GVHD by day 100 after myeloablative allogeneic hematopoietic stem-cell transplantation.

Thirty controlled, randomized, or nonrandomized trials were included in the systematic review.

Of these 11 studies, involving 428 patients, 7 were randomized control trials (RCTs), 1 was a nonrandomized trial, and 3 were observational studies.

We excluded studies with observational designs, nonrandomized trials, single-arm trials, and trials that did not report mortality outcomes.

Patient engagement in study design and novel nonrandomized trial designs may offer a path to increase clinical trial success.

Comparative trials are lacking, and recommendations must be based mainly on nonrandomized trials and will be influenced by personal experience.

One option for gathering data on tolerability and efficacy in children would be to use a nonrandomized trial to enroll parents willing to vaccinate their children and those who are hesitant.

METHODS The study was a prospective, nonrandomized trial of 30 patients with submandibular sialolithiasis who received gland-preserving treatment by either sialendoscopy-assisted techniques (Scope group; 14 patients) or transoral sialithotomy with or without dochoplasty (No Scope group; 16 patients).

RESULTS A total of 22 comparative studies comprising 11 randomized controlled trials and 11 nonrandomized trials were included for the analysis.

OBJECTIVE The objective of this open-label, nonrandomized trial was to evaluate the efficacy and safety of bilateral caudate nucleus deep brain stimulation (DBS) for treatment-resistant tinnitus.

Most evaluations of MBIs are either uncontrolled or nonrandomized trials.

Randomized and nonrandomized trials that investigated HIIT for the treatment of IC were included, with no exclusions based on exercise modality, protocol, or use of a comparator arm.

Objectives The authors performed a systematic review and meta-analysis of randomized and nonrandomized trials on the efficacy of dexrazoxane in patients with breast cancer who were treated with anthracyclines with or without trastuzumab.

STUDY DESIGN Prospective, experimental, nonrandomized trial.

Otherwise, national databases, registries, and nonrandomized trials were used.

Methods: A single-center, prospective, nonrandomized trial enrolled 100 consecutive PD for cancer.

METHODS This was an interventional, parallel assignment, nonrandomized trial.

Retrospective studies, studies with no comparative group, nonrandomized trials, case reports, editorials, reviews, expert opinion, and studies published in a language other than English were excluded.

In total, 230 studies were included: 19 (8%) randomized trials, 17 (7%) nonrandomized trials, and 194 (85%) observational studies.

Twelve randomized controlled trials (n = 1131) delivered to medical patients were included in the review, and a further 11 nonrandomized trials (n = 300) were included in a secondary analysis.

Based on nonrandomized trials, the current German guidelines recommend at least three cylinders with ≤ 14-gauge needle biopsy.

A two-arm nonrandomized trial was conducted with 785 allied health and preprofessional teaching students studying first-year public health courses.

In total, 22 studies were eligible including 7 randomized controlled trial, 1 nonrandomized trial, and 14 prospective observational studies.

Methods A systematic search of multiple databases from 1973 to July 2018 was conducted for randomized and nonrandomized trials investigating technology-supported self-guided nutrition and physical activity interventions.

Major eligibility criteria were a comparative evaluation of a self-management intervention for adults with epilepsy, delivered in the outpatient setting or by remote technology and using a randomized trial, nonrandomized trial, controlled beforeafter, or prospective cohort study design.

LIMITATIONS: The study was limited by being a retrospective, nonrandomized trial with short follow-up.

Results: This review includes 25 studies (17 randomized control trials plus eight nonrandomized trials).

We identified 18 relevant randomized controlled trials (RCTs) and 29 nonrandomized trials.

Mature data from several randomized and prospective nonrandomized trials have contributed to the development of consensus guidelines for selecting the most appropriate candidates ABPI.

RECENT FINDINGS In contrast to the results of previous nonrandomized trials, the STICH trial showed that patients with viability defined by nuclear perfusion imaging or dobutamine echocardiography did not have improved survival with CABG compared with optimal medical therapy.

Focused Clinical Question: Does LIAEX within the first 4 weeks following SRC hasten symptom resolution? Summary of Key Findings: Two randomized controlled trials (RCT) and 1 nonrandomized trial involving adolescent athletes (10-19 y) were included.

Though there is much reason to be optimistic, the studies conducted to date with pediatric participants are almost exclusively small-scale and many are open-label, unblinded, nonrandomized trials or case reports.

Methods Women with breast cancer scheduled for AC (n = 28) who participated in a nonrandomized trial of exercise training (ET; n = 14) or usual care (UC; n = 14) during AC completed a follow-up evaluation 12 months post-AC completion (16 months from baseline).

The most frequent study design was a one or more group, nonrandomized trial or cohort (67.