scholarly journals Comparison of the Safety and Efficacy of Interferon Alpha-2a and Cyclosporine-A When Combined With Glucocorticoid in the Treatment of Refractory Behçet’s Uveitis: A Randomized Controlled Prospective Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Yujing Qian ◽  
Yi Qu ◽  
Fei Gao ◽  
Minghang Pei ◽  
Anyi Liang ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Complete Remission ◽  
Outcome Measures ◽  
Interferon Alpha ◽  
Cyclosporine A ◽  
Prospective Trial ◽  
Secondary Outcome ◽  
Improvement Rate ◽  
Randomized Controlled ◽  
Behçet’S Uveitis

Purpose: To evaluate and compare the efficacy and safety of interferon alpha-2a (IFN-α2a) and cyclosporine-A (CsA) in patients with refractory Behçet’s uveitis (BU).Methods: In this 12-month randomized, controlled, prospective trial, 26 participants (44 eyes) completed the study. Patients were randomly allocated to the IFN-α2a or CsA groups. All patients in both groups received a standardized prednisone burst and tapering schedule as per protocol. The primary outcome measures were response rate, complete remission rate, and tolerance rate. The secondary outcome measures included time to achieve complete remission, the logarithm of the minimum angle of resolution (logMAR) of best-corrected visual acuity (BCVA), and Behçet’s disease ocular attack score 24 (BOS24). T-tests and non-parametric tests were used to compare quantitative variables, and chi-square tests were performed to compare qualitative variables.Results: The response and complete remission rates were 85.7% (12/14 patients) and 50.0% (7/14 patients) in the IFN-α2a group, compared with 66.7% (8/12 patients) and 25.0% (3/12 patients) in the CsA group, respectively (p > 0.05). Complete remission was achieved at 3.3 and 7.0 months after initiation of IFN-α2a and CsA (p = 0.023). LogMAR BCVA significantly improved 1 month after IFN-α2a initiation (23 eyes) (p = 0.002), and this beneficial effect remained statistically significant during the entire follow-up period (p < 0.05); however, this improvement was not observed in the CsA group (21 eyes). At the endpoint, LogMAR BCVA in the IFN-α2a group was significantly better (0.22 vs. 0.31, p = 0.031) with a higher improvement rate (60.9 vs. 47.6%, p > 0.05). Moreover, compared to the CsA group, more eyes in the IFN-α2a group had a lower BOS24 score (87.0 vs. 57.1%, p = 0.042). None of the patients had any side effects that influenced the medication adherence.Conclusion: Compared to CsA plus corticosteroid, IFN-α2a plus corticosteroid appears to induce a better treatment response, a significantly greater improvement in visual acuity, and more stable remission of intraocular inflammation in a 12-month study period.

scholarly journals PREWARMING FOR PREVENTION OF PERIOPERATIVE HYPOTHERMIA IN PATIENTS WITH COMBINED EPIDURAL AND GENERAL ANESTHESIA: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Author(s):  
Dang Tinh Pham ◽  
Thi Ngoc Le ◽  
Ton Ngoc Vu Phan ◽  
Parshal Bhandari ◽  
Sairah Zia ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
General Anesthesia ◽  
Outcome Measures ◽  
Medical Center ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Perioperative Hypothermia ◽  
Randomized Controlled ◽  
Physical Status Classification ◽  
American Society

OBJECTIVE The aim of this study was to access the influence of active warming after epidural anesthesia (EDA) and before general anesthesia in prevention of perioperative hypothermia. METHOD This randomized controlled trial was conducted in the department of anesthesiology in university medical center of Ho Chi Minh city, Vietnam from December 2019 until April 2020. This trial included 60 adult patients who were scheduled for major abdominal surgery with a duration of at least 120 minutes and under combined general anesthesia and EDA. Patients were excluded if age was below 18 years, American Society Anesthesiologists’ physical status classification of IV or higher, or refusal of EDA. Written informed consent was obtained for all patients. Patients were divided randomly into two groups. The first group received 10 minutes of active air-forced warming after EDA before the induction of general anesthesia. The second group was covered with a blanket 10 minutes after EDA and before general anesthesia. Core temperatures were recorded throughout the study. The primary outcome measures were the incidence of perioperative hypothermia and the degree of hypothermia. The secondary outcome measures were rate and time for body temperature to return to normal and incidence of postoperative body shivering. RESULTS Without active warming (n = 21), 70% of patients became hypothermic (<36°C) postoperatively. Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia decreased the incidence of postoperative hypothermia to 26.7% (n = 8). CONCLUSION Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia is efficient in reducing the incidence of perioperative hypothermia.

Westeinde Sciatica Trial: randomized controlled study of bed rest and physiotherapy for acute sciatica

2002 ◽  
Vol 96 (1) ◽  
pp. 45-49 ◽  
Author(s):  
Derk J. Hofstee ◽  
Johanna M. M. Gijtenbeek ◽  
Peter H. Hoogland ◽  
Hans C. van Houwelingen ◽  
Alfred Kloet ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Outcome Measures ◽  
Bed Rest ◽  
Control Treatment ◽  
Secondary Outcome ◽  
Content Type ◽  
Randomized Controlled ◽  
And Control ◽  
Acute Sciatica ◽  
Fine Print

Object. The authors conducted a study to compare the efficacies of three nonsurgical treatment strategies in patients with sciatica. Their hypothesis was that bed rest, physiotherapy, and continuation of activities of daily living (ADLs) (control treatment) are each of equivalent efficacy. Methods. This randomized controlled trial was designed for comparison of bed rest, physiotherapy, and continuation of ADLs. The setting was an outpatient clinic. General practitioners were asked to refer patients for treatment as soon as possible. The authors enrolled 250 patients (< 60 years of age) with sciatica of less than 1-month's duration and who had not yet been treated with bed rest or physiotherapy. Primary outcome measures were radicular pain (based on a visual analog pain scale [VAPS]) and hampered ADLs (Quebec Disability Scale [QDS]). Secondary outcome measures were the rates of treatment-related failure and surgical treatment. Measures were assessed at baseline and during follow up at 1, 2, and 6 months. Mean differences in VAPS and QDS scores between bed rest and control treatment were 2.5 (95% confidence interval [CI] −6.4 to 11.4) and −4.8 (95% CI −10.6 to 0.9) at 1 month and 0.9 (95% CI −8.7 to 10.4) and −2.7 (95% CI −9.9 to 4.4) at 2 months, respectively. The respective differences between physiotherapy and control treatment were 0.8 (95% CI −8.2 to 9.8) and −0.5 (95% CI −6.3 to 5.3) at 1 month and −0.3 (95% CI −9.4 to 10) and 0.0 (95% CI −7.2 to 7.3) at 2 months. The respective odds ratios for treatment failure and surgical treatment of bed rest compared with control treatment were 1.6 (95% CI 0.8–3.5) and 1.5 (95% CI 0.7–3.6) at 6 months. When physiotherapy was compared with control treatment, these ratios were 1.5 (95% CI 0.7–3.2) and 1.2 (95% CI 0.5–2.9) at 6 months, respectively. Conclusions. Bed rest and physiotherapy are not more effective in acute sciatica than continuation of ADLs.

scholarly journals The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Outcome Measures ◽  
Vestibular Migraine ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

scholarly journals Evaluating the CARE4Carer Blended Care Intervention for Partners of Patients With Acquired Brain Injury: Protocol for a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Vincent CM Cox ◽  
Vera PM Schepers ◽  
Marjolijn Ketelaar ◽  
Caroline M van Heugten ◽  
Johanna MA Visser-Meily
Keyword(s):  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Acquired Brain Injury ◽  
Secondary Outcome ◽  
Face To Face ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Blended Care

BACKGROUND Support programs for partners of patients with acquired brain injury are necessary since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psychoeducation, skill building, problem solving, and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. OBJECTIVE This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. METHODS A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. RESULTS The effect of the intervention on the primary and secondary outcome measures will be determined. Additional a process evaluation will be conducted. CONCLUSIONS The findings of this study will be used to improve the care for partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. CLINICALTRIAL Dutch Trial Register NTR6197; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6197 (Archived by WebCite at http://www.webcitation.org/6xHBAxx0y)

scholarly journals Online prenatal trial in mindfulness sleep management (OPTIMISM): protocol for a pilot randomized controlled trial

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Ira Kantrowitz-Gordon ◽  
Susan M. McCurry ◽  
Carol A. Landis ◽  
Rachel Lee ◽  
Dahee Wi
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Pregnant Women ◽  
Outcome Measures ◽  
Mindfulness Meditation ◽  
Controlled Trial ◽  
Self Management ◽  
Secondary Outcome ◽  
Post Intervention ◽  
Randomized Controlled

Abstract Background Sleep deficiency affects a majority of pregnant women with significant impact on daily function, mood, and pregnancy and birth outcomes. This ongoing study combines two evidence-based strategies for improving sleep and mood, mindfulness meditation and cognitive-behavioral therapy for insomnia (CBT-I), in a unique online format to address the particular needs of pregnant women. The purpose of this study is to test the feasibility and estimate the efficacy of this novel 6-week online mindfulness meditation intervention to help pregnant women in remission from depression self-manage insomnia. Methods This is a two-arm, parallel group randomized controlled trial. A total of 50 pregnant women between 12 and 28 weeks gestation will be recruited from the community and randomly assigned to a mindfulness or education-only control group in a 1:1 ratio. During the study, all participants will complete six weekly online modules, daily sleep diaries, and optional participation in a treatment-specific online discussion forum. Feasibility outcome measures will include study recruitment, retention, intervention adherence (number of online modules completed, number of meditation days per week), and intervention acceptability (8-item questionnaire). The primary clinical outcome measure will be sleep quality measured with the Pittsburgh Sleep Quality Index. Secondary outcome measures will include sleep measured with actigraphy and diaries (sleep efficiency, total sleep time, total wake time), Patient-Reported Outcomes Measurement Information System (PROMIS) measures (fatigue, sleep-related impairment, sleep disturbance); mood (depression, anxiety, positive affect, quality of life); and self-management and behavior change (potential self-efficacy, self-regulation, sleep problem acceptance, and trait mindfulness). Assessments will occur at baseline and post-intervention; an additional acceptability survey will be completed 4 weeks postpartum. Analyses will examine within-group differences in outcome change scores from baseline to post-intervention. Open-ended feedback will be analyzed using qualitative content analysis. Discussion This research is innovative in addressing sleep in pregnancy using a self-management research design and methods that can be accessible and cost-effective for large numbers of pregnant women. The results from this study will inform intervention refinement and efficacy testing of the intervention in a larger randomized controlled trial. Trial registration ClinicalTrials.gov, NCT04016428. Registered on 11 July 2019. Updated version registered on 26 July 2019.

Tinnitus Management: Randomized Controlled Trial Comparing Extended-Wear Hearing Aids, Conventional Hearing Aids, and Combination Instruments

2017 ◽  
Vol 28 (06) ◽  
pp. 546-561 ◽  
Author(s):  
James A. Henry ◽  
Garnett McMillan ◽  
Serena Dann ◽  
Keri Bennett ◽  
Susan Griest ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Hearing Aids ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Point Reduction ◽  
Clinically Significant

Background: Whereas hearing aids have long been considered effective for providing relief from tinnitus, controlled clinical studies evaluating this premise have been very limited. Purpose: The purpose of this study was to systematically determine the relative efficacy of conventional receiver-in-the-canal hearing aids (HA), the same hearing aids with a sound generator (HA+SG), and extended-wear, deep fit hearing aids (EWHA), to provide relief from tinnitus through a randomized controlled trial. Each of these ear-level devices was a product of Phonak, LLC. Research Design: Participants were randomized to HA, HA+SG, or EWHA and wore bilaterally fit devices for about 4 months. Fittings, adjustments, and follow-up appointments were conducted to comply with company guidelines and to ensure that all participants attended appointments on the same schedule. At 4–5 months, participants returned to complete final outcome measures, which concluded their study participation. Study Sample: Participants were 55 individuals (mean age: 63.1 years) with mild to moderately-severe hearing loss who: (a) did not currently use hearing aids; (b) reported tinnitus that was sufficiently bothersome to warrant intervention; and (c) were suitable candidates for each of the study devices. Data Collection and Analysis: The primary outcome measure was the Tinnitus Functional Index (TFI). Secondary outcome measures included hearing-specific questionnaires and the Quick Speech in Noise test (QuickSIN). The goal of the analysis was to evaluate efficacy of the EWHA and HA+SG devices versus the HA standard device. Results: There were 18 participants in each of the HA and EWHA groups and 19 in the HA+SG group. Gender, age, and baseline TFI severity were balanced across treatment groups. Nearly all participants had a reduction in tinnitus symptoms during the study. The average TFI change (improvement) from baseline was 21 points in the HA group, 31 points in the EWHA group, and 33 points in the HA+SG group. A “clinically significant” improvement in reaction to tinnitus (at least 13-point reduction in TFI score) was seen by 67% of HA, 82% of EWHA, and 79% of HA+SG participants. There were no statistically significant differences in the extent to which the devices reduced TFI scores. Likewise, the hearing-specific questionnaires and QuickSIN showed improvements following use of the hearing aids but these improvements did not differ across device groups. Conclusions: There is insufficient evidence to conclude that any of these devices offers greater relief from tinnitus than any other one tested. However, all devices appear to offer some improvement in the functional effects of tinnitus.

Efficacy and Safety of Traditional Chinese Medicine in COVID-2019: A Study Protocol for an Open-Label, Multicenter Randomized Controlled Trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Zhengzhong Yuan ◽  
Xiaoqiong Pan ◽  
Jizhou Zhang ◽  
Jiahui Zhu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Measures ◽  
Lung Injury Score ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Introduction: The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. It directly leads to high morbidity and mortality, but also results in a devastating effect on the global economy. Unfortunately, there are no effective therapies or vaccines for it. Hence, we designed a randomized trial to evaluate the efficacy and safety of Traditional Chinese Medicine for treating patients with COVID-19.Methods and analysis: This is an open-label, multicenter randomized controlled clinical trial. One hundred and twelve patients infected by SARS-CoV-2 will be randomly assigned to the experimental or the control group in an equal ratio. The patients in control group will accept routine supportive clinically care including the therapies of anti-viral, anti-bacterial and ameliorating the related symptoms, while patients in the experimental group will be asked to take traditional Chinese medicine depending on the different stages of the disease for consecutive 14 days in addition to supportive care. All data will be gathered at baseline and on days 3, 7, 10 and 14. The primary outcome measures will be the time of Reverse Transcription PCR testing of respiratory tract sample turns to be negative. Secondary outcome measures will include Murray lung injury score, MuLBSTA score and TCM ( Traditional Chinese Medicine ) Syndrome Scoring System. A laboratory test will be taken before and after treatment to assess the safety of TCM.Discussion: The study may help to identify the the efficacy and safety of Traditional Chinese Medicine in treating COVID-2019.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000030759.Registered on March 13th 2020-Retrospectively registered, http://www.chictr.org.cn/.

scholarly journals Electromyogram Biofeedback in Patients with Fibromyalgia: A Randomized Controlled Trial

2017 ◽  
Vol 24 (1) ◽  
pp. 33-39 ◽  
Author(s):  
Eva Baumueller ◽  
Andreas Winkelmann ◽  
Dominik Irnich ◽  
Martin Weigl
Keyword(s):  
Health Status ◽  
Usual Care ◽  
Outcome Measures ◽  
Pain Threshold ◽  
Pressure Pain Threshold ◽  
Emg Biofeedback ◽  
Additional Patient ◽  
Secondary Outcome ◽  
Pressure Pain ◽  
Randomized Controlled

Background/Aim: Electromyogram (EMG) biofeedback is used in chronic pain but its effectiveness in patients with fibromyalgia is unclear. The objective of this randomized controlled clinical trial was to evaluate the effectiveness of EMG biofeedback in patients with fibromyalgia. Methods: Patients were recruited from a waiting list at the fibromyalgia day care clinic at the University Hospital Munich. The study intervention comprised 14 sessions of EMG biofeedback during 8 weeks in addition to the usual care. The control intervention was usual care alone. Assessments were scheduled before intervention (T0), after intervention (T1), and 3 months after the end of intervention (T2). The primary outcome measure was the Fibromyalgia Impact Questionnaire (FIQ). Secondary outcome measures included additional patient-oriented measures and the pressure-pain threshold in the trapezius muscles. Effectiveness was analyzed by significance tests and standardized effect sizes (ES). Results: 36 patients completed the study. EMG biofeedback did not improve the health status (FIQ, T1: p = 0.95, ES = 0.02; T2: p = 0.52, ES = 0.26). Among the secondary outcome measures, only the pressure-pain threshold at the trapezius muscles showed an improvement in the intervention group (T1: p = 0.016, ES = 0.84). Conclusion: EMG biofeedback showed no health status improvement in patients with fibromyalgia.

scholarly journals C1 inhibitor in canine intravascular hemolysis (C1INCH): study protocol for a randomized controlled trial

2019 ◽  
Vol 15 (1) ◽  
Author(s):  
Robert Goggs ◽  
Erica Behling-Kelly
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Complement Activation ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Pharmacokinetic Analysis ◽  
Intravascular Hemolysis ◽  
Randomized Controlled ◽  
Transfusion Requirements ◽  
Duration Of Hospitalization

Abstract Background Immune-mediated hemolytic anemia (IMHA) is a common disease that affects all breeds of dogs and is associated with significant morbidity and mortality. Intravascular hemolysis of erythrocytes in IMHA is caused by complement activation and is often fatal. No current treatments target complement activation in canine IMHA. Human C1 esterase (C1-INH) reduces canine complement-mediated hemolysis in vitro, and a recent pharmacokinetic analysis of an FDA licensed formulation of C1-INH in dogs confirmed that a 50 IU/kg dose of C1-INH is safe to administer to dogs, and effectively inhibits canine complement mediated hemolysis ex-vivo. The C1INCH randomized controlled trial will evaluate the efficacy of this drug in dogs with intravascular hemolysis. Methods We will conduct a multicenter, placebo-controlled double-blind randomized clinical trial of C1-INH in dogs with intravascular hemolysis due to IMHA. We will randomize 18 dogs to receive three doses of intravenous C1-INH or saline in 24 h. Immunosuppressive and antithrombotic therapies will be standardized. Primary outcome measures will be changes in plasma free hemoglobin, serum concentrations of LDH, bilirubin, and haptoglobin. Using patient samples, we will evaluate complement activation in canine IMHA using a novel C5b-9 ELISA assay, flow cytometric detection of C3b on RBC, and by measurement of residual plasma complement activity. Secondary outcome measures will be survival to hospital discharge, duration of hospitalization, number and volume of red blood cell transfusions, and rescue therapy requirements. We will monitor dogs for adverse drug reactions. Sample size was estimated from pilot data on LDH and hemolysis index (HI) in dogs with IMHA. To detect 2-way differences between the upper and lower 50% of the LDH and HI values of equivalent size with 80% power at P < 0.05 will require 9 dogs in each arm. Discussion We anticipate that IV administration of C1-INH will significantly inhibit complement mediated hemolysis in dogs with intravascular IMHA, as determined by blood biomarker measurements (decreased plasma hemoglobin, LDH and bilirubin, increased haptoglobin). We expect this will translate into significant reductions in transfusion requirements and duration of hospitalization. Trial registration This trial has been prospectively registered with the AVMA registry (AAHSD005025).

scholarly journals Randomized controlled trials in neurosurgery: an observational analysis of trial discontinuation and publication outcome

2017 ◽  
Vol 127 (4) ◽  
pp. 857-866 ◽  
Author(s):  
Aimun A. B. Jamjoom ◽  
Angus B. Gane ◽  
Andreas K. Demetriades
Keyword(s):  
Randomized Controlled Trials ◽  
Outcome Measures ◽  
Publication Rate ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Start Date ◽  
Randomized Controlled ◽  
Link Type ◽  
Unknown Status ◽  
Trial Discontinuation

OBJECTIVEThis study aimed to determine the trial discontinuation and publication rate of randomized controlled trials (RCTs) in neurosurgery.METHODSTrials registered from 2000 to 2012 were identified on the website clinicaltrials.gov using a range of key words related to neurosurgery. Any trials that were actively recruiting or had unknown status were excluded. Included trials were assessed for whether they were discontinued early on the clinicaltrials.gov database; this included trials identified as withdrawn, suspended, or terminated in the database. For included trials, a range of parameters was identified including the subspecialty, primary country, study start date, type of intervention, number of centers, and funding status. Subsequently, a systematic search for published peer-reviewed articles was undertaken. For trials that were discontinued early or were found to be unpublished, principal investigators were sent a querying email.RESULTSSixty-four neurosurgical trials fulfilled our inclusion criteria. Of these 64, 26.6% were discontinued early, with slow or insufficient recruitment cited as the major reason (57%). Of the 47 completed trials, 14 (30%) remained unpublished. Discontinued trials showed a statistically significant higher chance of remaining unpublished (88%) compared with completed trials (p = 0.0002). Industry-funded trials had a higher discontinuation rate (31%) compared with non–industry-funded trials (23%), but this result did not reach significance (p = 0.57). Reporting of primary outcome measures was complete in 20 (61%) of 33 trials. For secondary outcome measures, complete reporting occurred in only 11 (33.3%) of 33.CONCLUSIONSMore than a fifth (26.6%) of neurosurgical RCTs are discontinued early and almost a third of those that are completed remain unpublished. This result highlights significant waste of financial resources and clinical data.

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