Agreement of Primary Outcomes in Chiropractic-Related Clinical Trials Registered in clinicaltrials.gov with Corresponding Publication.

2020 ◽  
Author(s):  
Robert Cote ◽  
Stephen Perle ◽  
Derek Martin
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Primary Outcome ◽  
A Priori ◽  
Feasibility Studies ◽  
Primary Outcome Measure ◽  
Publication Rate ◽  
Secondary Outcome ◽  
Study Protocols ◽  
Published Paper

Abstract Introduction:Previous analysis of registered clinical trials has found a disappointing number of study protocols result in publications which change what the registered a priori primary outcome measure is. Likewise, there is a disappointing rate of unpublished trials. Similar research has not been published on chiropractic-related studies. Primarily this investigation determined if reported primary outcomes in chiropractic-related clinical trials registered in clinicaltrials.gov match their published results. Secondarily, other outcome measures and publication status are assessed.Methodology:Clinicaltrials.gov was searched for chiropractic-related trials, using the search terms “chiropractic”, “chiropractor”, and having a completed status. Publication status was determined by searching PubMed (pubmed.gov), Index to Chiropractic Literature (chiroindex.org), and Google Scholar (scholar.google.com) through 29 May 2020. If the study was published, outcome measures were compared between the clinicaltrials.gov entry and the published paper to assess for consistency by two independent investigators. If there was disagreement between investigators, a third evaluated the data and decided if the published paper agreed with the clinicaltrials.gov entry.Results:Within clinicaltrials.gov 171 chiropractic-related protocols were identified. Twenty-five (25) had results posted and 102 were published. Twenty-nine of those entries produced multiple papers consisting of protocols, plot/feasibility studies, clinical trials, and poster presentations. Of the 102 studies published, 92 (90.2%) had agreement between their primary outcome and the listed entry on clinicaltrials.gov and 82 (80.4%) agreed with the secondary outcomes in the registered protocol. Entries on clinicaltrials.gov had a 59.6% (102/171) publication rate and a 14.6% (25/171) rate of displaying their results. Conclusion:A modest rate of agreement (90.2%) between clinicaltrails.gov entries and the 102 published papers (59.6% publication rate) were found. While chiropractic-related clinical trials are fewer in number compared to medical trials, chiropractic-related research has a substantially better rate of primary and secondary outcome concordance with registered protocols and a better publication rate. Investigators need to continue to upload results onto clinicaltrials.gov and seek publication regardless of the study findings. It is important to publish negative results so as not to introduce publication bias into systematic reviews and meta-analyses. Both positive and negative findings are important when evaluating treatments and determining the best care for patients.

scholarly journals Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047341
Author(s):  
Caroline Marra ◽  
William J Gordon ◽  
Ariel Dora Stern
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Outcome Measures ◽  
Remote Monitoring ◽  
Search Algorithm ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Digital Products ◽  
Clinical Trial Registry ◽  
Before And After

ObjectivesIn an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic.DesignWe applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials.SettingAll trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021.Outcome measuresThe primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019–February 2020) compared with the 10 months following (May 2020–February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants).ResultsCDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19.ConclusionsThese findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants’ COVID-19 diagnosis.

Statistical analysis, trial design and duration in Alzheimer's disease clinical trials: a review

2011 ◽  
Vol 24 (5) ◽  
pp. 689-697 ◽  
Author(s):  
P. A. Thompson ◽  
D. E. Wright ◽  
C. E. Counsell ◽  
J. Zajicek
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Statistical Analysis ◽  
Statistical Methods ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Primary Analysis

ABSTRACTBackground: The social and economic burden of Alzheimer's disease (AD) and its increasing prevalence has led to much work on new treatment strategies and clinical trials. The search for surrogate markers of disease progression continues but traditional parallel group trial designs that use well-established, but often insensitive, clinical outcome measures predominate.Methods: We performed a systematic search across the Cochrane Library and PubMed abstracts published between January 2004 and August 2009. Information regarding the clinical trial methodology, outcome measures, intervention type and primary statistical analysis techniques was extracted and categorized, according to a standard protocol.Results: We identified 149 papers describing results from clinical trials in AD containing sufficient detail for our purposes. The largest proportion (38%) presented results of trials based on tests of cognition as the primary outcome measure. The primary analysis in most papers (85%) was a univariate significance test of a single primary outcome measure.Conclusions: The majority of trials reported a comparison of baseline and end-point assessment over relatively short patient follow-up periods, using univariate statistical methods to compare differences between intervention and control groups in the primary analysis. There is considerable scope to introduce newer statistical methods and trial designs in treatment evaluations in AD.

scholarly journals Combining Lovastatin and Minocycline for the Treatment of Fragile X Syndrome: Results From the LovaMiX Clinical Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Camille Champigny ◽  
Florence Morin-Parent ◽  
Laurence Bellehumeur-Lefebvre ◽  
Artuela Çaku ◽  
Jean-François Lepage ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Fragile X Syndrome ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Fragile X ◽  
Combined Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Global Score

Background: Limited success of previous clinical trials for Fragile X syndrome (FXS) has led researchers to consider combining different drugs to correct the pleiotropic consequences caused by the absence of the Fragile X mental retardation protein (FMRP). Here, we report the results of the LovaMiX clinical trial, the first trial for FXS combining two disease-modifying drugs, lovastatin, and minocycline, which have both shown positive effects when used independently.Aim: The main goals of the study were to assess the safety and efficacy of a treatment combining lovastatin and minocycline for patients with FXS.Design: Pilot Phase II open-label clinical trial. Patients with a molecular diagnostic of FXS were first randomized to receive, in two-step titration either lovastatin or minocycline for 8 weeks, followed by dual treatment with lovastatin 40 mg and minocycline 100 mg for 2 weeks. Clinical assessments were performed at the beginning, after 8 weeks of monotherapy, and at week 20 (12 weeks of combined therapy).Outcome Measures: The primary outcome measure was the Aberrant Behavior Checklist-Community (ABC-C) global score. Secondary outcome measures included subscales of the FXS specific ABC-C (ABC-CFX), the Anxiety, Depression, and Mood Scale (ADAMS), the Social Responsiveness Scale (SRS), the Behavior Rating Inventory of Executive Functions (BRIEF), and the Vineland Adaptive Behavior Scale second edition (VABS-II).Results: Twenty-one individuals out of 22 completed the trial. There were no serious adverse events related to the use of either drugs alone or in combination, suggesting good tolerability and safety profile of the combined therapy. Significant improvement was noted on the primary outcome measure with a 40% decrease on ABC-C global score with the combined therapy. Several outcome measures also showed significance.Conclusion: The combination of lovastatin and minocycline is safe in patients for FXS individuals and appears to improve several elements of the behavior. These results set the stage for a larger, placebo-controlled double-blind clinical trial to confirm the beneficial effects of the combined therapy.

scholarly journals 188 The Use of a Group Based Upper Limb Programme in Improving Outcome in Acute Stroke Rehabilitation

2019 ◽  
Vol 48 (Supplement_3) ◽  
pp. iii17-iii65
Author(s):  
Kerri Donnelly ◽  
Enya Mulcahy ◽  
Catherine Merrick ◽  
Orla Fitzgerald
Keyword(s):  
Acute Stroke ◽  
Grip Strength ◽  
Outcome Measures ◽  
Upper Limb ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Dominant Hand ◽  
Nine Hole Peg Test

Abstract Background After a stroke 85% of patients experience altered arm function. Current research demonstrates that increasing upper limb rehabilitation results in improved outcomes (Ward et al., 2019). The Graded Repetitive Arm Supplementary Programme (GRASP) group is an established adjunctive therapy in the stroke service. The group provides additional therapy for suitable patients with upper extremity deficits. The group is run jointly by a physiotherapist and an occupational therapist. Patients attend twice weekly for a one hour period in addition to their regular therapy. The GRASP group consists of 3 levels of varying abilities and patients are categorised by their Fugl-Meyer score. Methods A prospective audit was completed in 2019 and data was collected using a word document and excel spread sheet. Standardised outcome measures were completed on admission and discharge to establish upper limb ability. The primary outcome measure was the Fugl-Meyer and the secondary outcome measures were the nine hole peg test and grip strength using the Dynamometer. Results 12 patients attended the GRASP group over this period. 75% were males. The average age was 76 years with the age range from 48-95 years. 58% of patients experienced upper limb weakness in their non-dominant hand. Post intervention data was not obtained for 5 patients due to unforeseeable discharge from the acute setting. Preliminary data to date shows that our primary outcome measure improved in 86% of patients with increases ranging from 2-11 points on the Fugl-Meyer score (Minimally Clinical Important Difference =5points). Our secondary outcome measures demonstrated patients had no change (28%) or an improvement (72%) in grip strength and 100% of patients improved on the time taken to complete the nine hole peg test. Conclusion The GRASP group was found to be effective in improving upper limb outcome measures in an acute stroke inpatient hospital setting.

A randomized, double-blind, placebo-controlled trial of memantine in a behaviorally enriched sample of patients with moderate-to-severe Alzheimer's disease

2013 ◽  
Vol 25 (6) ◽  
pp. 919-927 ◽  
Author(s):  
Nathan Herrmann ◽  
Serge Gauthier ◽  
Neli Boneva ◽  
Ole Michael Lemming
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Neuropsychiatric Symptoms ◽  
Primary Outcome Measure ◽  
Community Dwelling ◽  
Secondary Outcome ◽  
Double Blind

ABSTRACTBackground: Agitation and aggression in Alzheimer's disease (AD) are amongst the most serious of neuropsychiatric symptoms, and contribute to poor outcomes and worse quality of life. Previous studies have suggested a benefit for memantine on agitation and aggression, but none have examined its efficacy in community-dwelling patients with significant agitation and aggression at baseline, utilizing these behaviors as a primary outcome measure.Methods: Patients with moderate-to-severe AD with Neuropsychiatric Inventory (NPI) total score ≥13 and NPI agitation/aggression score ≥1 were randomized to placebo or 20-mg memantine in a double-blind, 24-week trial. Co-primary outcome measures were behavior, measured by total NPI score, and cognition, using the Severe Impairment Battery (SIB). Secondary outcome measures included global assessment, function and other measures of behavior. This trial was registered as Clinicaltrials.gov: NCT00857649.Results: A total of 369 patients (average age = 75, average MMSE = 12) were randomized to placebo or memantine. The study was prematurely terminated due to recruitment problems. There were no statistically significant differences between memantine and placebo in mean change from baseline in NPI, SIB, or any of the secondary outcome measures. Behavior improved in both groups (total NPI change scores −3.90 ± 1.24 for memantine and −5.13 ± 1.23 for placebo). Memantine was generally well tolerated and patient retention in both treatment arms was good.Conclusions: The study failed to show the superiority of memantine in this sample of patients with moderate-to-severe AD with significant baseline agitation and aggression. Methodological limitations could have contributed to these results.

scholarly journals Efficacy of a strategy-based intervention on text-level reading comprehension in persons with aphasia: a study protocol for a repeated measures study

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e048126
Author(s):  
Sarah-Maria Thumbeck ◽  
Philipp Schmid ◽  
Sophie Chesneau ◽  
Frank Domahs
Keyword(s):  
Reading Comprehension ◽  
Outcome Measures ◽  
Repeated Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Primary Objective ◽  
Secondary Outcome ◽  
Waiting Period ◽  
Reading Activities

IntroductionAt least 68% of persons with aphasia (PWA) experience reading difficulties. Even though strategy-based interventions are a promising treatment approach for text level reading comprehension deficits in PWA, empirical evidence for their efficacy remains rare. The primary objective of this study is the analysis of the efficacy of a strategy-based intervention on text-level reading comprehension and on reading activities in PWA.Methods and analysisIn a repeated measures trial, 24 PWA will first participate in a waiting period and then in a strategy-based intervention (14 face-to-face-sessions, 60 min each). We will apply two combinations of strategies to treat either the microstructure or the macrostructure, respectively. Participants will be randomly allocated to two parallel groups that will receive these combinations in interchanged sequences. Assessments will be implemented before and after each period as well as 3 and 6 months after the intervention. The primary outcome measure is text-level reading comprehension measured with a German version of the Test de Compréhension de Textes (TCT-D) and represented by the score TCT-D Total . A non-blinded and a blinded rater will evaluate the primary outcome measure. Secondary outcome measures will address specific reading functions, reading activities and cognitive functions. The sample size was determined with an a priori power analysis. For statistical analysis, we will use contrast analyses within repeated measures analysis of variance models. We expect significant improvements in primary and secondary outcome measures during the intervention as compared with changes during the waiting period.Ethics and disseminationThis study was approved by the ethics committee of Deutscher Bundesverband für akademische Sprachtherapie und Logopädie (20–10074-KA-MunmErw+Ko). Results and relevant data will be disseminated in peer-reviewed journals, at conferences and on the Open Science Framework.Trial registration numberDRKS00021411 (see Supplementary Table 1).

scholarly journals The Addition of MRI to CT Based Stroke and TIA Evaluation Does Not Impact One year Outcomes

2013 ◽  
Vol 7 (1) ◽  
pp. 17-22 ◽  
Author(s):  
Hebah Hefzy ◽  
Elizabeth Neil ◽  
Patricia Penstone ◽  
Meredith Mahan ◽  
Panayiotis Mitsias ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Recurrent Stroke ◽  
Multiple Logistic Regression Analysis ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Ct Angiogram ◽  
Primary Stroke Center ◽  
One Year

Background: The 2010 American Academy of Neurology guideline for the diagnosis of acute ischemic stroke recommends MRI with diffusion weighted imaging (DWI) over noncontrast head CT. No studies have evaluated the influence of imaging choice on patient outcome. We sought to evaluate the variables that influenced one-year outcomes of stroke and TIA patients, including the type of imaging utilized. Methods: Patients were identified from a prospectively collected stroke and TIA database at a single primary stroke center during a one-year period. Data were abstracted from patient electronic medical records. The primary outcome measure was death, myocardial infarction, or recurrent stroke within the following year. Secondary outcome measures included predictors of getting an MRI study. Results: 727 consecutive patients with a discharge diagnosis of stroke or TIA were identified (616 and 111 respectively); 536 had CT and MRI, 161 had CT alone, 29 had MRI alone, and one had no neuroimaging. On multiple logistic regression analysis, there were no differences in primary or secondary outcome measures among different imaging strategies. Predictors of the primary outcome measure included age and NIHSS, while performance of a CT angiogram (CTA) predicted a decreased odds of death, stroke, or MI. The strongest predictor of having an MRI was admission to a stroke unit. Conclusions: These results suggest that long-term (one-year) patient outcomes may not be influenced by imaging strategy. Performance of a CTA was protective in this cohort. A randomized trial of different imaging modalities should be considered.

scholarly journals Topical diclofenac vs placebo for the treatment of chronic Achilles tendinopathy: A randomized controlled clinical trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0247663
Author(s):  
Erin Bussin ◽  
Brian Cairns ◽  
Tommy Gerschman ◽  
Michael Fredericson ◽  
Jim Bovard ◽  
...  
Keyword(s):  
Outcome Measures ◽  
A Priori ◽  
Pressure Pain Threshold ◽  
Minimum Clinically Important Difference ◽  
Primary Outcome Measure ◽  
Achilles Tendinopathy ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Patient Reported ◽  
Topical Diclofenac

Introduction The application of topical diclofenac has been suggested as a possible treatment for Achilles tendinopathy. Our aim was to answer the question, is topical diclofenac more effective than placebo for the treatment of Achilles tendinopathy?. Methods 67 participants with persistent midportion or insertional Achilles tendinopathy were randomly assigned to receive a 4 week course of 10% topical diclofenac (n = 32) or placebo (n = 35). The a priori primary outcome measure was change in severity of Achilles tendinopathy (VISA-A score) at 4 and 12 weeks. Secondary outcome measures included numeric pain rating, and patient-reported change in symptoms using a 7 point scale, from substantially worse to substantially better. Pressure pain threshold (N) and transverse tendon stiffness (N/m) were measured over the site of maximum Achilles tendon pathology at baseline and 4 weeks. Results There were no statistically or clinically significant differences between the diclofenac and placebo groups in any of the primary or secondary outcome measures at any timepoint. Average VISA-A score improved in both groups (p<0.0001), but the improvements were marginal: at 4 weeks, the improvements in VISA-A were 9 (SD 11) in the diclofenac group and 8 (SD 12) in the placebo group, and at 12 weeks the improvements were 9 (SD 16) and 11 (SD13) respectively–these average changes are smaller than the minimum clinically important difference of the VISA-A. Conclusion The regular application of topical diclofenac for Achilles tendinopathy over a 4 week period was not associated with superior clinical outcomes to that achieved with placebo.

scholarly journals Vibration therapy versus standard treatment for tennis elbow: A randomized controlled study

2018 ◽  
Vol 26 (3) ◽  
pp. 230949901879274 ◽  
Author(s):  
Nicholas Duncan Furness ◽  
Alistair Phillips ◽  
Sian Gallacher ◽  
James Charles Sherard Beazley ◽  
Jonathan Peter Evans ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Primary Outcome ◽  
Standard Treatment ◽  
Outcome Measure ◽  
Tennis Elbow ◽  
Dropout Rate ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Vibration Therapy ◽  
Outcome Scores

Aim: To determine whether a mechanical, high-frequency vibration device (Tenease™) can improve pain and function for the treatment of tennis elbow (TE), compared with standard treatment. Methods: Adults presenting to an elbow clinic with a clinical diagnosis of TE were randomized to standard treatment with physiotherapy, activity modification and analgesia or standard treatment plus Tenease therapy. Tenease therapy consisted of a 6-week period of treatment using the Tenease device with three 10-min episodes each day. The primary outcome measure was the quick Disabilities of the Arm, Shoulder and Hand score at 6 months, with scores also taken at 6 weeks. Secondary outcome measures were the Patient Rated Tennis Elbow Evaluation Score and EuroQol 5-Dimension Visual Analogue Scale at the same time points. Results: Fifty-four patients were recruited into the study. Following randomization and initial dropout, 18 patients were included in the standard group and 27 in the Tenease group. Both groups reported improvements in primary outcome measure scores. The control group had a mean score of 44.3 (standard deviation (SD) = 18.8) at baseline, which dropped to 31.2 (SD = 17.2) at 6 months ( p = 0.002). The Tenease group had a mean score of 43.2 (SD = 22.7) at baseline, which dropped to 23.4 (SD = 15.0) at 6 months ( p = 0.064). Similar improvements were seen in secondary outcome measures with none reaching statistical significance. There were no statistically significant differences seen between the primary outcome scores at 6 weeks ( p = 0.9) or 6 months ( p = 0.5). No complications were noted in either group. Conclusions: Vibration therapy did not result in any statistically significant improvement in functional outcome scores compared to standard treatment for TE. It is important to note that this was a relatively small cohort and a high dropout rate was observed.

Intervention Outcomes of Two Treatments for Muscle Tension Dysphonia: A Randomized Controlled Trial

2019 ◽  
Vol 62 (2) ◽  
pp. 272-282 ◽  
Author(s):  
Christopher R. Watts ◽  
Amy Hamilton ◽  
Laura Toles ◽  
Lesley Childs ◽  
Ted Mau
Keyword(s):  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Muscle Tension ◽  
Primary Outcome Measure ◽  
Voice Therapy ◽  
Secondary Outcome ◽  
Treatment Groups ◽  
Perceptual Evaluation ◽  
Muscle Tension Dysphonia

Purpose The aim of this study was to test the hypothesis that stretch-and-flow voice therapy (SnF) is noninferior to resonant voice therapy (RVT) for speakers with muscle tension dysphonia. Method Participants with primary muscle tension dysphonia were randomly assigned to 1 of 2 treatment groups. Participants received 6 sessions of either SnF or RVT for 6 weeks (1 session per week). Pretreatment and posttreatment audio recordings of sustained vowels and connected speech were acquired. Response to treatment was assessed using the voice handicap index (VHI) as the primary outcome measure. Secondary outcome measures included the acoustic voice quality index, the smoothed cepstral peak prominence, and scales from the Consensus Auditory-Perceptual Evaluation of Voice instrument. Data were analyzed for 21 participants who completed the study (12 in the SnF group, 9 in the RVT group). Results Direction of change for the primary outcome measure and all 3 secondary outcome measures at posttreatment was in the direction of improvement for both SnF and RVT. Confidence intervals for VHI measures did not cross the null effect line on forest plots, suggesting significant effects for both treatments on the primary outcome measure. The effect sizes for pretreatment to posttreatment changes in VHI were large for both treatment groups. Similar results were found for the secondary acoustic outcome measures. There were statistically significant pretreatment to posttreatment changes in the primary and secondary outcome measures for patients receiving both treatments, indicating significant improvement in response to both RVT and SnF. There were no statistically significant differences in pretreatment to posttreatment changes in the primary outcome measure or any secondary outcome measure between the two groups. The within-group pretreatment to posttreatment changes in Consensus Auditory-Perceptual Evaluation of Voice scales did not reach statistical significance for either RVT or SnF. Conclusions Both SnF and RVT produced positive treatment response in speakers with muscle tension dysphonia, with no statistically significant difference in the outcome measures between the two treatments. This suggests that SnF is noninferior to RVT and that both are effective options for treating vocal hyperfunction. Results from this study also support previous findings documenting the sensitivity of multidimensional acoustic measurements to treatment response.

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