Methods, transparency and reporting of clinical trials in orthodontics and periodontics

Objective: The aim of this study was to explore the methods, reporting and transparency of clinical trials in orthodontics and compare them to the field of periodontics, as a standard within dentistry. Design/setting: Cross-sectional bibliographic study Methods: A total of 300 trials published in 2017–2018 and evenly distributed in orthodontics and periodontics were selected, assessed and analysed statistically to explore key aspects of the conduct and reporting of orthodontic clinical trials compared to trials in periodontics. Results: Several aspects are often neglected in orthodontic and periodontic trials and could be improved upon, including use of statistical expertise (22.3% of assessed trials), blinding of outcome assessors (62.3%), prospective trial registration (12.0%), adequate sample size calculation (35.7%), adherence to CONSORT (14.3%) and open data sharing (4.3%). The prevalence of statistically significant findings among orthodontic and periodontic trials was 62.3%, which was significantly associated with several methodological traits like statistician involvement (odds ratio [OR] = 0.5; 95% confidence interval [CI] = 0.3–0.9), blind outcome assessor (OR = 0.5; 95% CI = 0.2–1.0), lack of prospective trial registration (OR = 2.8; 95% CI = 1.3–5.9) and non-adherence to CONSORT (OR = 4.5; 95% CI = 1.3–15.8). Conclusions: Although trials in orthodontics seem to be significantly worse compared to periodontics in aspects like trial registration, adherence to CONSORT and declaration of competing interests or financial support, their methods do seem to have improved considerably in recent years.

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Clinical Trial Registration in Physical Therapy Journals: A Cross-Sectional Study

Physical Therapy ◽

10.2522/ptj.20120531 ◽

2014 ◽

Vol 94 (1) ◽

pp. 83-90 ◽

Cited By ~ 12

Author(s):

Abraham Samuel Babu ◽

Sundar Kumar Veluswamy ◽

Pratiksha Tilak Rao ◽

Arun G. Maiya

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Physical Therapy ◽

Prospective Trial ◽

Theory And Practice ◽

Trial Registration ◽

Clinical Trial Registration ◽

Cross Sectional ◽

Editorial Policies ◽

Journal Editors

Background Clinical trial registration has become an important part of editorial policies of various biomedical journals, including a few physical therapy journals. However, the extent to which editorial boards enforce the need for trial registration varies across journals. Objective The purpose of this study was to identify editorial policies and reporting of trial registration details in MEDLINE-indexed English-language physical therapy journals. Design This study was carried out using a cross-sectional design. Methods Editorial policies on trial registration of MEDLINE-indexed member journals of the International Society of Physiotherapy Journal Editors (ISPJE) (Journal of Geriatric Physical Therapy, Journal of Hand Therapy, Journal of Neurologic Physical Therapy, Journal of Orthopaedic and Sports Physical Therapy, Journal of Physiotherapy [formerly Australian Journal of Physiotherapy], Journal of Science and Medicine in Sport, Manual Therapy, Physical Therapy, Physical Therapy in Sport, Physiotherapy, Physiotherapy Research International, Physiotherapy Theory and Practice, and Revista Brasileira de Fisioterapia) were reviewed in April 2013. Full texts of reports of clinical trials published in these journals between January 1, 2008, and December 31, 2012, were independently assessed for information on trial registration. Results Among the 13 journals, 8 recommended trial registration, and 6 emphasized prospective trial registration. As of April 2013, 4,618 articles were published between January 2008 and December 2012, of which 9% (417) were clinical trials and 29% (121/417) of these reported trial registration details. A positive trend in reporting of trial registration was observed from 2008 to 2012. Limitations The study was limited to MEDLINE-indexed ISPJE member journals. Conclusions Editorial policies on trial registration of physical therapy journals and a rising trend toward reporting of trial registration details indicate a positive momentum toward trial registration. Physical therapy journal editors need to show greater commitment to prospective trial registration to make it a rule rather than an option.

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Statistical basis of clinical trials

10.1093/med/9780199609956.003.0009 ◽

2014 ◽

Author(s):

Jeremy Prout ◽

Tanya Jones ◽

Daniel Martin

Keyword(s):

Clinical Trials ◽

Statistical Analysis ◽

Observational Study ◽

Odds Ratio ◽

Binary Data ◽

Statistical Significance ◽

Sample Size Calculation ◽

Number Needed To Treat ◽

Drug Trials ◽

Research Types

This chapter summarizes some aspects of study design and statistical analysis to allow the anaesthetist to appraise research. Types of observational study are described and aspects of interventional studies such as sample size calculation and power are explained. Research governance, phases of drug trials and levels of evidence are described. A section on statistical analysis includes expression of proportion for binary data (odds ratio, number needed to treat) and use of probability and confidence intervals to measure statistical significance.

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Associations of Medications With Lower Odds of Typical COVID-19 Symptoms: Cross-Sectional Symptom Surveillance Study

JMIR Public Health and Surveillance ◽

10.2196/22521 ◽

2020 ◽

Vol 6 (4) ◽

pp. e22521

Author(s):

Dietmar Urbach ◽

Friedemann Awiszus ◽

Sven Leiß ◽

Tamsin Venton ◽

Alexander Vincent De Specht ◽

...

Keyword(s):

Clinical Trials ◽

Statin Therapy ◽

Odds Ratio ◽

Safety Data ◽

World Health ◽

Postal Code ◽

Rt Pcr ◽

Cross Sectional ◽

Housing Status ◽

Increased Risk

Background As the COVID-19 pandemic continues to spread across the globe, the search for an effective medication to treat the symptoms of COVID-19 continues as well. It would be desirable to identify a medication that is already in use for another condition and whose side effect profile and safety data are already known and approved. Objective The objective of this study was to evaluate the effect of different medications on typical COVID-19 symptoms by using data from an online surveillance survey. Methods Between early April and late-July 2020, a total of 3654 individuals in Lower Saxony, Germany, participated in an online symptom-tracking survey conducted through the app covid-nein-danke.de. The questionnaire comprised items on typical COVID-19 symptoms, age range, gender, employment in patient-facing healthcare, housing status, postal code, previous illnesses, permanent medication, vaccination status, results of reverse transcription polymerase chain reaction (RT-PCR) and antibody tests for COVID-19 diagnosis, and consequent COVID-19 treatment if applicable. Odds ratio estimates with corresponding 95% CIs were computed for each medication and symptom by using logistic regression models. Results Data analysis suggested a statistically significant inverse relationship between typical COVID-19 symptoms self-reported by the participants and self-reported statin therapy and, to a lesser extent, antihypertensive therapy. When COVID-19 diagnosis was based on restrictive symptom criteria (ie, presence of 4 out of 7 symptoms) or a positive RT-PCR test, a statistically significant association was found solely for statins (odds ratio 0.28, 95% CI 0.1-0.78). Conclusions Individuals taking statin medication are more likely to have asymptomatic COVID-19, in which case they may be at an increased risk of transmitting the disease unknowingly. We suggest that the results of this study be incorporated into symptoms-based surveillance and decision-making protocols in regard to COVID-19 management. Whether statin therapy has a beneficial effect in combating COVID-19 cannot be deduced based on our findings and should be investigated by further study. Trial Registration German Clinical Trials Register DRKS00022185; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022185; World Health Organization International Clinical Trials Registry Platform U1111-1252-6946

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Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers

10.1101/2021.08.23.21262478 ◽

2021 ◽

Author(s):

Maia Salholz-Hillel ◽

Daniel Strech ◽

Benjamin Gregory Carlisle

Keyword(s):

Clinical Trials ◽

Full Text ◽

Evidence Synthesis ◽

Open Data ◽

Policy Decision ◽

Final Analysis ◽

World Health ◽

Cross Sectional ◽

Link Type ◽

Medical Centers

AbstractObjectiveTo evaluate links between registration and publication across clinical trials led by German university medical centers (UMCs) and registered in either ClinicalTrials.gov or the German Clinical Trials Registry (DRKS). Inadequate links make trial publications and registrations less findable and compromise evidence synthesis and health policy decision making. The World Health Organization (WHO) and others call for better adoption of this straightforward transparency practice.DesignCross-sectional bibliographic studySettingGerman UMC clinical trialsMethodsWe used automated strategies to download and extract data from trial registries, PubMed, and trial publications for a cohort of all registered, published clinical trials conducted across German UMCs and completed between 2009 and 2017. We implemented regular expressions to detect and classify publication identifiers (DOI and PMID) in registrations, and trial registrations numbers (TRNs) in publication metadata, abstract, and full-text.Main outcome measuresThe proportion of trial registrations that reference a known results publication. The proportion of results publications that report the known TRN in the metadata, abstract, and full-text.Secondary analysesWe constructed exploratory logistic regression models to investigate the relationship between trial completion date, registry, and registration-publication linking.ResultsOnly 20% (373/1,895) of trials have a linked publication (DOI or PMID) in the registration as well as the TRN in the publication full-text, abstract, and metadata, and only 25% (477) of trials met the CONSORT and ICMJE guidelines to include TRNs in both the full-text and the abstract. 17% (327) of trials had no links. The most common link was TRN reported in the full-text (60%, 1,137). ClinicalTrials.gov trials were overall better linked than DRKS trials, and this difference appears to be driven by PubMed and registry infrastructure, rather than by trialists. Of trials reporting a TRN in the abstract, trials in ClinicalTrials.gov were more likely than trials in DRKS to have the TRN captured in the PubMed metadata. Most (78%, 662/849) ClinicalTrials.gov registrations with a publication link were automatically indexed from PubMed metadata, which is not possible in DRKS.ConclusionGerman UMCs have not comprehensively linked trial registrations and publications by both including a structured reference to the publication in the registration, and reporting TRNs in results publications. In addition to improved linking by trialists, changes in the PubMed TRN capturing process (such as automated strategies like those developed in this study) and automated indexing of publications in DRKS would make trial registrations and results more findable.Open Data and CodeAll code and the final analysis data for this study are available at https://github.com/maia-sh/reg-pub-link. Raw data is available at https://github.com/maia-sh/intovalue-data.

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ON SAMPLE SIZE CALCULATION BASED ON ODDS RATIO IN CLINICAL TRIALS

Journal of Biopharmaceutical Statistics ◽

10.1081/bip-120016231 ◽

2002 ◽

Vol 12 (4) ◽

pp. 471-483 ◽

Cited By ~ 33

Author(s):

Hansheng Wang ◽

Shein-Chung Chow ◽

Gang Li

Keyword(s):

Clinical Trials ◽

Sample Size ◽

Odds Ratio ◽

Sample Size Calculation

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Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations

BMJ ◽

10.1136/bmj.m982 ◽

2020 ◽

pp. m982 ◽

Cited By ~ 4

Author(s):

Mustafa Al-Durra ◽

Robert P Nolan ◽

Emily Seto ◽

Joseph A Cafazzo

Keyword(s):

Impact Factor ◽

Prospective Trial ◽

Cross Sectional Study ◽

International Committee ◽

Trial Registration ◽

World Health ◽

Cross Sectional ◽

Journal Citation Reports ◽

The Impact ◽

Publishing Journal

Abstract Objectives To evaluate the compliance with prospective registration and inclusion of the trial registration number (TRN) in published randomised controlled trials (RCTs), and to analyse the rationale behind, and detect selective registration bias in, retrospective trial registration. Design Cross sectional analysis. Data sources PubMed, the 17 World Health Organization’s trial registries, University of Toronto library, International Committee of Medical Journal Editors (ICMJE) list of member journals, and the InCites Journal Citation Reports. Study selection criteria RCTs registered in any WHO trial registry and published in any PubMed indexed journal in 2018. Results This study included 10 500 manuscripts published in 2105 journals. Overall, 71.2% (7473/10500) reported the TRN and 41.7% (3013/7218) complied with prospective trial registration. The univariable and multivariable analyses reported significant relations (P<0.05) between reporting the TRN and the impact factor and ICMJE membership of the publishing journal. A significant relation (P<0.05) was also observed between prospective trial registration and the registry, region, condition, funding, trial size, interval between paper registration and submission dates, impact factor, and ICMJE membership of the publishing journal. A manuscript published in an ICMJE member journal was 5.8 times more likely to include the TRN (odds ratio 5.8, 95% confidence interval 4.0 to 8.2), and a published trial was 1.8 times more likely to be registered prospectively (1.8, 1.5 to 2.2) when published in an ICMJE member journal compared with other journals. This study detected a new form of bias, selective registration bias, with a higher proportion (85.2% (616/723)) of trials registered retrospectively within a year of submission for publication. Higher rates of retrospective registrations were observed within the first three to eight weeks after enrolment of study participants. Within the 286 RCTs registered retrospectively and published in an ICMJE member journal, only 2.8% (8/286) of the authors included a statement justifying the delayed registration. Reasons included lack of awareness, error of omission, and the registration process taking longer than anticipated. Conclusions This study found a high compliance in reporting of the TRN for trial papers published in ICMJE member journals, but prospective trial registration was low.

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Prospective Trial Registration and Publication Rates of Randomized Clinical Trials in Digital Health: A Cross Sectional Analysis of Global Trial Registries

10.1101/19004390 ◽

2019 ◽

Author(s):

Mustafa Al-Durra ◽

Robert P. Nolan ◽

Emily Seto ◽

Joseph A. Cafazzo

Keyword(s):

Clinical Trials ◽

Digital Health ◽

Prospective Trial ◽

Trial Registration ◽

Reporting Bias ◽

Selective Reporting ◽

Funding Sources ◽

Publication Rates ◽

Selective Reporting Bias ◽

The U.S

AbstractRegistration of clinical trials was introduced to mitigate the risk of publication and selective reporting bias in the realm of clinical research. The prevalence of publication and selective reporting bias in trial results has been evidenced through scientific research. This bias may compromise the ethical and methodological conduct in the design, implementation and dissemination of evidence-based healthcare interventions. Principal investigators of digital health trials may be overwhelmed with challenges that are unique to digital health research, such as the usability of the intervention under test, participant recruitment, and retention challenges that may contribute to non-publication rate and prospective trial registration. Our primary research objective was to examine the prevalence of prospective registration and publication rates in digital health trials. We included 417 trials that enrolled participants in 2012 and were registered in any of the seventeen WHO registries. The prospective registration and publication rates were at (38.4%) and (65.5%) respectively. We identified a statistically significant (P<.001) “Selective Registration Bias” with 95.7% of trials published within a year after registration, were registered retrospectively. We reported a statistically significant relationship (P=.003) between prospective registration and funding sources, with industry-funded trials having the lowest compliance with prospective registration at (14.3%). The lowest non-publication rates were in the Middle East (26.7%) and Europe (28%), and the highest were in Asia (56.5%) and the U.S. (42.5%). We found statistically significant differences (P<.001) between trial location and funding sources with the highest percentage of industry funded trials in Asia (17.3%) and the U.S. (3.3%).

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Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries

Trials ◽

10.1186/s13063-021-05423-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Bassey Edem ◽

Chukwuemeka Onwuchekwa ◽

Oghenebrume Wariri ◽

Esin Nkereuwem ◽

Oluwatosin O. Nkereuwem ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Controlled Trial ◽

Descriptive Analysis ◽

Sub Saharan Africa ◽

Trial Registration ◽

Reporting Bias ◽

Clinical Trial Registration ◽

Cross Sectional ◽

Sub Saharan

Abstract Objective Prospective registration of clinical trials is an ethical, scientific, and legal requirement that serves several functions, including minimising research wastage and publication bias. Sub-Saharan Africa (SSA) is increasingly hosting clinical trials over the past few years, and there is limited literature on trends in clinical trial registration and reporting in SSA. Therefore, we set out to determine the trends in clinical trials registered in SSA countries between 2010 and July 2020. Methods A cross-sectional study design was used to describe the type of clinical trials that are conducted in SSA from 1 January 2010 to 31 July 2020. The registries searched were ClinicalTrials.gov (CTG), the Pan African Clinical Trials Register (PACTR), and the International Standard Randomized Controlled Trial Number (ISRCTN). Data were extracted into Excel and imported into STATA for descriptive analysis. Results CTG had the highest number of registered trials at 2622, followed by PACTR with 1501 and ISRCTN with 507 trials. Trials were observed to increase gradually from 2010 and peaked at 2018–2019. Randomised trials were the commonest type, accounting for at least 80% across the three registries. Phase three trials investigating drugs targeted at infections/infestations were the majority. Few completed trials had their results posted: 58% in ISRCTN and 16.5% in CTG, thus suggesting reporting bias. Conclusion Despite the gradual increase in clinical trials registered during the period, recent trends suggest a drop in the number of trials registered across the region. Strengthening national and regional regulatory capacity will improve clinical trial registration and minimise reporting bias in completed clinical trials.

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Missing Evidence: Exploring Unpublished Trials in Victoria, Australia

Journal of Global Oncology ◽

10.1200/jgo.18.28700 ◽

2018 ◽

Vol 4 (Supplement 2) ◽

pp. 96s-96s

Author(s):

C. Allan ◽

A. Chapman ◽

C. Parker ◽

A. Boltong ◽

J. Millar

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Scientific Journal ◽

Prospective Trial ◽

Scientific Paper ◽

The United States ◽

Trial Registration ◽

Data Set ◽

Conference Abstract ◽

Publication Rates

Background: Clinical trial registries were established to improve the transparency and completeness of clinical trial reporting and a number of policies have been introduced to encourage or mandate their use. While prospective trial registration has been endorsed in Australia, there is currently no legal requirement for researchers to register or communicate findings from clinical trials. There has also been, to the best of our knowledge, no analysis previously undertaken on publication rates for clinical trials performed in Australia. Aim: We aimed to determine the proportion of clinical trials that remain 'unpublished' in Victoria, Australia´s second most populous state, between 2009 and 2013. Methods: We used data reported to Cancer Council Victoria's Cancer Trials Management Scheme (CTMS) between 2009 and 2013, to identify trials that had recruited a new patient or recorded any follow-up patient activity in the specified time period. Using this data, we conducted a systematic search of ClinicalTrials.gov , the Australia and New Zealand Clinical Trials Registry (ANZCTR), PubMed and Google for records of the trial. Trial registration numbers, acronyms and scientific titles were used as primary search terms. Results were characterized by type of publication (i.e., whether it was an accredited scientific paper or other) and source location. Results: Of the trials reported to the CTMS between 2009 and 2013, 777 trials were included in this investigation; the majority (58.8%) were randomized controlled trials (RCTs). Compared with previously published findings, communication of trial results in this study was high; 70% of trials published results in an accredited scientific journal and a further 10% in alternate form, such as a conference abstract or media release. Publication rates were higher for trials with a commercial sponsor (85%) compared with trials sponsored by a cooperative group (77%). Nearly 8% of trials in this study had not been registered on an international clinical trials register. Only 39% of unregistered trials had published results. Of the registered trials, those registered on ClinicalTrials.gov were more likely to be published (86%) compared with trials listed on ANZCTR (68%). Between 2009 and 2013 , 8% of trials registered on ClinicalTrials.gov , in our data set, were terminated; 70% of these trials published results. Conclusion: Although the rate at which clinical trial findings were published in Victoria was higher in this investigation compared with equivalent overseas data, trials registered on ClinicalTrials.gov were more likely to publish results than unregistered trials or trials registered on ANZCTR. This suggests a potential need for trial registration and publication guidelines in Australia, similar to that of the United States where the requirements and procedures for submitting registration and summary result information for clinical trials on ClinicalTrials.gov have been compulsory for the last decade.

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Associations of Medications With Lower Odds of Typical COVID-19 Symptoms: Cross-Sectional Symptom Surveillance Study (Preprint)

10.2196/preprints.22521 ◽

2020 ◽

Author(s):

Dietmar Urbach ◽

Friedemann Awiszus ◽

Sven Leiß ◽

Tamsin Venton ◽

Alexander Vincent De Specht ◽

...

Keyword(s):

Clinical Trials ◽

Statin Therapy ◽

Odds Ratio ◽

Safety Data ◽

World Health ◽

Postal Code ◽

Rt Pcr ◽

Cross Sectional ◽

Housing Status ◽

Increased Risk

BACKGROUND As the COVID-19 pandemic continues to spread across the globe, the search for an effective medication to treat the symptoms of COVID-19 continues as well. It would be desirable to identify a medication that is already in use for another condition and whose side effect profile and safety data are already known and approved. OBJECTIVE The objective of this study was to evaluate the effect of different medications on typical COVID-19 symptoms by using data from an online surveillance survey. METHODS Between early April and late-July 2020, a total of 3654 individuals in Lower Saxony, Germany, participated in an online symptom-tracking survey conducted through the app covid-nein-danke.de. The questionnaire comprised items on typical COVID-19 symptoms, age range, gender, employment in patient-facing healthcare, housing status, postal code, previous illnesses, permanent medication, vaccination status, results of reverse transcription polymerase chain reaction (RT-PCR) and antibody tests for COVID-19 diagnosis, and consequent COVID-19 treatment if applicable. Odds ratio estimates with corresponding 95% CIs were computed for each medication and symptom by using logistic regression models. RESULTS Data analysis suggested a statistically significant inverse relationship between typical COVID-19 symptoms self-reported by the participants and self-reported statin therapy and, to a lesser extent, antihypertensive therapy. When COVID-19 diagnosis was based on restrictive symptom criteria (ie, presence of 4 out of 7 symptoms) or a positive RT-PCR test, a statistically significant association was found solely for statins (odds ratio 0.28, 95% CI 0.1-0.78). CONCLUSIONS Individuals taking statin medication are more likely to have asymptomatic COVID-19, in which case they may be at an increased risk of transmitting the disease unknowingly. We suggest that the results of this study be incorporated into symptoms-based surveillance and decision-making protocols in regard to COVID-19 management. Whether statin therapy has a beneficial effect in combating COVID-19 cannot be deduced based on our findings and should be investigated by further study. CLINICALTRIAL German Clinical Trials Register DRKS00022185; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022185; World Health Organization International Clinical Trials Registry Platform U1111-1252-6946

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