title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Acknowledgements | We thank Mark Solms, Charles Fischer, Harriet Wolfe, Cheryl Goodrich, Linda Goodman, Bart Blinder, Jean Nicolas Despland, Nicolas de Coulon, Erwin Sturm, Lisa Kallenbach-Kaminski, Andju Labuhn, Elisabeth Imhorst, Christine Huth, Serge Croes, Silvia Janko-Milch, Manfred Beutel as well as 72 psychoanalysts in our differe... | PMC10652457 | ||
Study registration | DRKS-ID: DRKS00016872.Date of Registration in DRKS: 2019/03/12 Last update 2023/01/30.Universal Trial Number (UTN): U1111-1229-2321. | PMC10652457 | ||
Authors’ contributions | MLB and BSP both international principal investigators and sponsors for the study conceived the study. MLB, BSP, GA, RB, NA, EH and TF developed the design of the study. GA, MLB, and BSP were major contributors in writing the manuscript. All authors read and approved the final manuscript. | PMC10652457 | ||
Funding | Open access funding provided by University of Lausanne This study is funded by grants of the International Psychoanalytic Association, the American Psychoanalytic Association, the Alfred Berman Foundation for Medical Research, and the Wallerstein foundation (The Robert S. Wallerstein Fellowship in Psychoanalytic Resear... | PMC10652457 | ||
Availability of data and materials | The datasets generated and/or analysed during the current study will be available on reasonable request to the PIs, via the corresponding author (gilles.ambresin@chuv.ch). | PMC10652457 | ||
Declarations | PMC10652457 | |||
Consent for publication | Not applicable. | PMC10652457 | ||
Competing interests | The authors declare no competing interests. | PMC10652457 | ||
References | PMC10652457 | |||
Background | RECRUITMENT | Online studies offer an efficient method of recruiting participants and collecting data. Whilst delivering an online randomised trial, we detected unusual recruitment activity. We describe our approach to detecting and managing suspected fraud and share lessons for researchers. | PMC10401790 | |
Methods | Our trial investigated the single and combined effects of different ways of presenting clinical audit and feedback. Clinicians and managers who received feedback from one of five United Kingdom national clinical audit programmes were emailed invitations that contained a link to the trial website. After providing consen... | PMC10401790 | ||
Results | MINOR | Following a rapid increase in trial participation, we identified 268 new voucher claims from three email addresses that we had reason to believe were linked. Further scrutiny revealed duplicate trial completions and voucher requests from 24 email addresses. We immediately suspended the trial, improved security measures... | PMC10401790 | |
Conclusion | Online studies offering incentives for participation are at risk of attempted fraud. Systematic monitoring and analysis can help detect such activity. Measures to protect study integrity include linking participant identifiers to study data, balancing study security and ease of participation, and safeguarding the alloc... | PMC10401790 | ||
Trial registration | International Standard Randomised Controlled Trial Number: ISRCTN41584028. Registration date is August 17, 2017. | PMC10401790 | ||
Keywords | PMC10401790 | |||
Background | RECRUITMENT | Online studies offer an efficient method of recruiting participants and collecting data. They are increasingly being used in health research, including for randomised trials. A PubMed search for randomised controlled trials featuring ‘online’ or ‘internet’ in the title found a total of 2742 records, with steady growth ... | PMC10401790 | |
Methods | PMC10401790 | |||
Overview of design | We conducted an online fractional factorial trial, described in full elsewhere [ | PMC10401790 | ||
Setting and participant recruitment | Myocardial Ischaemia, Trauma, Diabetes | BLOOD, RECRUITMENT, DIABETES | We developed our online trial in partnership with five United Kingdom (UK) national clinical audit programmes: the Myocardial Ischaemia National Audit Project (MINAP), the National Comparative Audit of Blood Transfusion (NCABT), the National Diabetes Core Audit (NDA), the Paediatric Intensive Care Network (PICANet), an... | PMC10401790 |
Results | PMC10401790 | |||
Detection of unusual study activity | RECRUITMENT | The study launched 10 April 2019 when the five national clinical audits emailed their initial distribution lists, totalling around 2000 recipients. We reached half of our target of 500 randomised participants within a fortnight. The NDA’s distribution list was far larger than that of the other four audits, and so we ha... | PMC10401790 | |
Primary and secondary analysis populations | SECONDARY | Given that study and personal data were not linked, we were unable to directly identify the study data from the 268 duplicate entries from the total 603 randomisations which took place during the same period. We therefore produced two datasets for analysis, aiming to protect trial validity by using objective criteria t... | PMC10401790 | |
Action taken | RECRUITMENT | Upon discovery of the suspicious activity, we promptly reported the incident to our independent study steering Committee, the research funder (National Institute for Health and Care Research), the University of Leeds School of Medicine Research Ethics Committee that had approved the study, and the study sponsor. We sub... | PMC10401790 | |
Study completion | RECRUITMENT | We successfully completed our trial after the second recruitment period. We identified the effects of varying the content and format of feedback from national clinical audits on health professionals’ responses [ | PMC10401790 | |
Discussion | RECRUITMENT | Online studies offer the potential for efficient and practical recruitment of large numbers of participants within a relatively brief period. However, our experience illustrates that this is not always necessarily a good thing. Without appropriate monitoring and safeguards, online studies are potentially vulnerable to ... | PMC10401790 | |
Conclusion | Online studies, and particularly those offering incentives for participation, are at risk of encountering fraudulent activity. Whilst live monitoring and systematic analysis of data can help detect such activity, researchers can build in measures during the design stage to help protect study integrity. These may includ... | PMC10401790 | ||
Acknowledgements | WRIGHT | We thank Sabahi Juma for her contribution to the trial and wider programme of research. In particular, she was the first to identify the problem detailed in this paper and enabled a rapid response. We also wish to thank the members of our study steering committee for their advice in relation to this incident. We thank ... | PMC10401790 | |
Authors’ contributions | This paper recounts our experience of discovering and managing an attempted fraud incident during the conduct of an online trial. TW was programme manager and drafted the manuscript; AWH was the trial statistician and led the identification of suspect data; CS was the Head of Research Integrity and Governance in the Fa... | PMC10401790 | ||
Funding | This study was funded by the National Institute for Health and Care Research (NIHR) Health Services & Delivery Research Programme (Grant Reference Number 16/04/13). The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The views expressed are those ... | PMC10401790 | ||
Availability of data and materials | The datasets generated and analysed during the current study are available from the corresponding author on reasonable request. | PMC10401790 | ||
Declarations | PMC10401790 | |||
Ethics approval and consent to participate | The original study and subsequent revisions were approved by the University of Leeds School of Medicine Research Ethics Committee (ref: 14–180). The trial website included a consent form which participants were required to complete before they could proceed to be randomised. | PMC10401790 | ||
Consent for publication | Not applicable. | PMC10401790 | ||
Competing interests | TW, RW, AJF, and RF are members of the Audit and Feedback MetaLab. The MetaLab is an international collaboration to advance learning and expertise on audit and feedback. AWH is a member of the Trials editorial board. | PMC10401790 | ||
References | PMC10401790 | |||
Background | Diabetes | TYPE 2 DIABETES MELLITUS, DIABETES | It is critical to assess implementation fidelity of evidence-based interventions and factors moderating fidelity, to understand the reasons for their success or failure. However, fidelity and fidelity moderators are seldom systematically reported. The study objective was to conduct a concurrent implementation fidelity ... | PMC10045092 |
Methods | prediabetes | REGRESSION, PREDIABETES, SDH | We applied the Conceptual Framework for Implementation Fidelity to assess implementation fidelity and factors moderating it across the four core intervention components: patient goal setting, education topic coaching, primary care (PC) visits, and referrals to address social determinants of health (SDH), using descript... | PMC10045092 |
Results | SDH | Content adherence was high for three components with nearly 80.0% of patients setting ≥ 1 goal, having ≥ 1 PC visit and receiving ≥ 1 education session. Only 45.0% patients received ≥ 1 SDH referral. After adjusting for patient gender, language, race, ethnicity, and age, the implementation site moderated adherence to g... | PMC10045092 | |
Conclusions | The fidelity to the four CHORD intervention components differed between the two implementation sites, demonstrating the challenges in implementing complex evidence-based interventions in different settings. Our findings underscore the importance of measuring implementation fidelity in contextualizing the outcomes of ra... | PMC10045092 | ||
Trial registration | The trial was registered with ClinicalTrials.gov on 30/12/2016 and the registration number is | PMC10045092 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12889-023-15477-2. | PMC10045092 | ||
Keywords | PMC10045092 | |||
Background | pre-diabetic, DM, Diabetes | PRE-DIABETIC, TYPE II DIABETES MELLITUS, SDH, DIABETES | The NationalInstitutes for Health recommends fidelity measurement in health behavior studies because without the knowledge of implementation fidelity, it may be impossible to draw correct inferences about the effectiveness of or to replicate an intervention [CHORD (Community Health Outreach to Reduce Diabetes), launche... | PMC10045092 |
Methods | PMC10045092 | |||
Trial participants and description | prediabetes | PREDIABETES | The CHORD trial’s priority population was patients with prediabetes receiving care at two PC clinics, the Manhattan campus of the VA NY Harbor Healthcare System (VA), and Bellevue Hospital Center (BH) of New York City’s municipal hospital system [Briefly, all PC clinicians within each site were randomized to interventi... | PMC10045092 |
Implementation of CHORD behavioral components | In the first component, CHWs established individualized goals with each patient and completed a 6-item, Patient Activation Measure (PAM) [ | PMC10045092 | ||
CHW training and fidelity monitoring | diabetes | DIABETES | To facilitate and standardize the implementation of the intervention, CHWs received comprehensive training and then ongoing feedback during weekly team meetings and case review sessions. To address behavioral components, CHWs completed training on coaching competencies, motivational interviewing, mental health and nutr... | PMC10045092 |
Data collection | Figure The Modified Version of the Conceptual Framework for Implementation Fidelity that guided Fidelity Assessment of the CHORD intervention (adapted from Carroll et al. and Hasson et al.)Data on the CFIR implementation fidelity elements identified above were collected from the start of the CHORD trial (December 2017)... | PMC10045092 | ||
Analysis | Fidelity measures of coverage, content and dose were reported using applicable descriptive statistics including percentage for categorical variables or median with inter-quartile ranges (IQRs) for continuous or count variables. To evaluate fidelity moderation, we computed unadjusted Among patients who completed intake ... | PMC10045092 | ||
Results | PMC10045092 | |||
Fidelity measures | PMC10045092 | |||
Content adherence | Eighty percent of patients had ≥ 1 successful encounter with the CHW (Table | PMC10045092 | ||
Impact of moderators on fidelity measures | PMC10045092 | |||
Patient activation | The median PAM score was 18 of a maximal score of 24. None of the fidelity measures were moderated by PAM score when dichotomized at the median (Supplemental Table | PMC10045092 | ||
Context | The implementation of the CHORD intervention was moderated by clinical site, with 60% of patients from BH and 40% from VA. VA patients had higher coverage and overall content adherence than BH. But a greater percentage of BH patients received coaching on all education modules and received all four core components. Thre... | PMC10045092 | ||
Discussion | prediabetes, diabetes | RECRUITMENT, PREDIABETES, DIABETES | In the CHORD study, we hypothesized that trained CHWs, through individualized goal setting, educational coaching, and facilitated referrals, would support positive lifestyle changes and prevent the onset of diabetes among patients with prediabetes. However, an intervention may not affect lifestyle change if it deviates... | PMC10045092 |
Study limitations | First, as a pragmatic trial, the CHORD implementation did not start or end on fixed days, because CHWs maintained continued contacts with their patients. As a result, some interventions, such as referrals, were delivered outside of the intervention period. We included them in this analysis if they were recorded by CHWs... | PMC10045092 | ||
Study strengths and contributions | Our study adds to the limited literature with systematically reported concurrent evaluation of implementation processes of multicomponent complex behavioral interventions [ | PMC10045092 | ||
Conclusion | diabetes | DIABETES | Our concurrent quantitative, implementation evaluation of a complex pragmatic trial to prevent diabetes in safety-net settings, found moderate-to-high adherence to the core components of the intervention, as well as moderation of several fidelity measures by implementation site, with no impact of the baseline patient-a... | PMC10045092 |
Acknowledgements | Presented in part at Society of General Internal Medicine (SGIM) 2021 conference and Academy Health ARM 2021 conference. We thank Dr. Erin Rogers, Assistant Professor at the Department of Population Health, NYU Grossman School of Medicine, for her valuable review of the manuscript. | PMC10045092 | ||
Authors’ contributions | AG conceptualized the paper, wrote the first draft and finalized the subsequent revisions along with data interpretation and data presentation. JH led data management, data analyses and data presentation along with reviewing multiple versions of the manuscript to offer critical edits and comments. SH performed data man... | PMC10045092 | ||
Authors’ information | Not applicable. | PMC10045092 | ||
Funding | Digestive, Diabetes | KIDNEY DISEASES, DIABETES | This study has undergone peer-review by and is supported by the National Institutes of Health—National Institute of Diabetes and Digestive and Kidney Diseases under award number R18DK110740. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Ins... | PMC10045092 |
Availability of data and materials | The datasets used and/or analyzed during the current study are not publicly available due to patient identifiers but is available from the corresponding author on reasonable request. | PMC10045092 | ||
Declarations | PMC10045092 | |||
Ethics approval and consent to participate | This study was approved by the New York University Langone Health (Protocol #:16–00690) and the Veterans Affairs (Protocol #:1609) Institutional Review Boards. Informed consent was obtained from all the participants in the study. All the procedures were followed in accordance with the relevant guidelines (eg. Declarati... | PMC10045092 | ||
Consent for publication | Not applicable. | PMC10045092 | ||
Competing interests | The authors declare no competing interests. | PMC10045092 | ||
References | PMC10045092 | |||
Keywords | toenail onychomycosis, onychomycosis | ONYCHOMYCOSIS | Keratolytic properties of urea 40% have long time used for the treatment of onychomycosis. Fractional ablative lasers enhance the delivery of topically applied photosensitizers improving photodynamic therapy (PDT) efficacy. The aim of this study was to compare the short- and medium-term efficacy of a pretreatment with ... | PMC10085931 |
Introduction | toenail onychomycosis, onychomycosis | FUNGAL NAIL INFECTION, DISEASE, ONYCHOMYCOSIS, SEPARATION, ONYCHOMYCOSIS | Fractional photothermolysis is considered a significant technological advance in dermatology. In fractional lasers, the laser beam is split into a pattern of microbeams. This results in thermal microscopic wounds into deep skin structures [Onychomycosis is a fungal nail infection often with thickening, discoloration an... | PMC10085931 |
Materials and methods | PMC10085931 | |||
Pretreatment | PMC10085931 | |||
Group I (urea 40% pretreatment) | HYPERKERATOSIS | 40% urea ointment was employed to soften the plates of the affected nails and vaseline was applied in periungual skin to prevent irritating effects of urea at high concentrations. Once the urea and vaseline were applied, the nail was covered by an occlusive dressing for 12 h at night. Urea softening treatment was limit... | PMC10085931 | |
Treatment | After any of the pretreatment used, a PDT mediated by MB (MB/PDT) was carried out, for which a solution of MB in water (2%) was applied to the affected nail, and 3 min later, the nail was photoactivated by a red light-emitting diode (LED) lamp (Aktilite | PMC10085931 | ||
Statistical analysis | ONYCHOMYCOSIS | Sample size calculation was based on detecting differences of more than 10 points between groups in the primary outcome (Onychomycosis Severity Index, OSI), assuming standard deviation of 6, error of 0.05 and power of 90% [To check assumptions of normality for the tested variables (OSI, degree of improvement, % of invo... | PMC10085931 | |
Results | No side reactions were found during the study period. MB application resulted in a widespread temporary discoloration of the toenails (Fig. Both groups demonstrated a continuous and significant decline in the OSI scores throughout the first 12 weeks of the evaluated period, but a slight rebound through the following 12... | PMC10085931 | ||
Acknowledgements | This research was supported by a grant from the Eugenio Rodríguez Pascual Foundation (Madrid, Spain) and by the Spanish Research Project MICINN (Ref.:PiD2020-114755GB-C31). The authors wish to thank Professor Mª José Ortiz for her assistance with the ethical evaluation of the study and Dr. Santiago Cano for his assista... | PMC10085931 | ||
Author contributions | Both authors contributed equally to producing the work. | PMC10085931 | ||
Funding | Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature. | PMC10085931 | ||
Declarations | PMC10085931 | |||
Competing interests | The authors declare no competing interests. | PMC10085931 | ||
References | PMC10085931 | |||
Abstract | PMC10114123 | |||
Background | Maternal age is increasingly recognized as a predictor of birth outcomes. Given the importance of birth and growth outcomes for children’s development, wellbeing and survival, this study examined the effect of maternal age on infant birth and growth outcomes at 6 months and mortality. Additionally, we conducted quantit... | PMC10114123 | ||
Methods | REGRESSION | We used data from randomized–controlled trials (RCTs) of 21 555 neonates in Burkina Faso conducted in 2019–2020. Newborns of mothers aged 13–19 years (adolescents) and 20–40 years (adults) were enrolled in the study 8–27 days after birth and followed for 6 months. Measurements of child’s anthropometric measures were co... | PMC10114123 | |
Results | Babies born to adolescent mothers on average had lower weight at birth, lower anthropometric measures at baseline, similar growth outcomes from enrolment to 6 months and higher odds of all-cause mortality by 6 months (adjusted OR = 2.17, 95% CI 1.35 to 3.47) compared with those born to adult mothers. In QBA, we found t... | PMC10114123 | ||
Conclusions | Our findings suggest that delaying the first birth from adolescence to adulthood may improve birth outcomes and reduce mortality of neonates. Babies born to younger mothers, who are smaller at birth, may experience catch-up growth, reducing some of the anthropometric disparities by 6 months of age.Babies born to adoles... | PMC10114123 | ||
Introduction | YOUNG MATERNAL AGE | Maternal age is increasingly recognized as a predictor of birth outcomes. Studies show that pregnancies in the extremes, at ages <17 and >40 years, are at a higher risk of negative birth outcomes than other age groups.Previous studies show that babies born to young mothers have a greater risk of very-pre-term and pre-t... | PMC10114123 | |
Methods | PMC10114123 | |||
Study design, setting and population | This analysis used data from a randomized–controlled trial of azithromycin vs placebo conducted to establish the efficacy and safety of administration of a dose of azithromycin during the neonatal period. | PMC10114123 | ||
Data collection and measures | wasting | WASTING | At baseline, trained field workers collected information of the infant and mother via a questionnaire. Child information included birthweight, type and timing of breastfeeding initiation and whether the child was born at a health centre. Maternal information collected included age, education level, number of previous p... | PMC10114123 |
Statistical analysis methods | REGRESSION | To assess the effect of maternal age on birth and growth outcomes, we used simple and multivariable linear regression. The changes in outcomes between maternal age groups were expressed as beta coefficients.Potential confounders of the association between maternal age and birth and growth outcomes and mortality were se... | PMC10114123 | |
Results | death |
Characteristics of mothers and infants enrolled in the NAITRE trial in Burkina Faso 2019–2020Excludes missing NAITRE, Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso; MUAC, mid-upper arm circumference; LAZ, Length-for-Age Z Score; WAZ: Weight-for-Age Z Score; WLZ, Weight-for-Lengt... | PMC10114123 | |
Discussion | ’ | In this study, babies born to adolescent mothers had poorer birth and neonatal outcomes as seen in baseline anthropometric measures and a higher risk of all-cause mortality by 6 months but similar growth outcomes at 6 months compared with those born to adult mothers.Similarly to findings of previous studies, babies bor... | PMC10114123 | |
Conclusion | Our findings show that delaying the first birth from adolescence to adulthood can improve birth outcomes and reduce mortality of neonates. Delaying pregnancy may allow young girls to mature mentally and physically and improve their social status, autonomy and decision-making, which can lead to better outcomes for their... | PMC10114123 | ||
Ethics approval | The randomized–controlled trial from which the data were obtained was reviewed and approved by the Comité d’Ethique pour la Recherche en Santé (National Research Ethics Committee) in Ouagadougou, Burkina Faso (protocol 2018–10-123) and the University of California, San Francisco Institutional Review Board (protocol 18–... | PMC10114123 | ||
Supplementary Material | Click here for additional data file. | PMC10114123 | ||
Data availability | The data for this study are available upon request. | PMC10114123 | ||
Supplementary data | PMC10114123 |
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