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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Sample size calculation | G* Power was used to conduct an a-priori sample size calculation. Based on previous research [ | PMC10508026 | ||
Results | Due to participant drop-out and failed attention checks, N = 1126 participants (94% of intended sample) were included in the final sample for analyses. See Fig.
Participant characteristics overall, and across the four conditionsCategorical variables are represented by counts/percentages, and continuous variables by me... | PMC10508026 | ||
Primary analyses | PMC10508026 | |||
Food orders | Mean orders for the four conditions are presented fully in Supplementary material VIII. Data of size choice are visually represented in Fig.
The proportion of participants opting for a larger size option for all three outlets across the four conditions | PMC10508026 | ||
Exploratory analyses | Exploratory analyses were conducted to investigate the source of the unexpected increased kcals ordered from the fast food outlet in proportional pricing conditions (Supplementary material XI). There was no main effect of pricing condition on kcals ordered from meals ordered, but there was for kcals from additional opt... | PMC10508026 | ||
Questionnaire responses | The majority (> 75%) of participants agreed that the virtual delivery app was representative of existing food delivery apps, and reported their orders where typical of what they would normally order. 20% of participants agreed that the food choices they made were influenced by how many calories they thought were in the... | PMC10508026 | ||
Discussion | SAID, SHOP | This study examined the impact of calorie labelling and proportional pricing in a virtual online food delivery platform on portion size choice, kcals ordered and hypothetical spend from beverage, sandwich and fast food outlets. Compared to non-labelling conditions, calorie labelling had no significant impact on portion... | PMC10508026 | |
Strengths and limitations | eating disorders | SHOP | This study was pre-registered and was stratified to represent the UK population in terms of gender and education. While virtual methodologies for food ordering are widely used [As is standard practice in eating behaviour research, individuals who were currently dieting, fasting, or had a history of eating disorders we ... | PMC10508026 |
Conclusions | Calorie labelling on food delivery platforms may effectively reduce calories ordered. Proportional pricing may prompt consumers to select smaller portion sizes, although further research in real-world settings will now be valuable. | PMC10508026 | ||
Authors’ contributions | AF conceptualised the study, developed methodology, collected the data, validated the data, analysed the data, wrote the initial draft and had responsibility for the final manuscript. ER conceptualised the study, developed the methodology, and critically reviewed and revised the manuscript. AJ advised and helped to dev... | PMC10508026 | ||
Funding | Obesity | OBESITY | The first author (AF) is funded by an ESRC case studentship, grant no: ES/P000665/1, with a contribution from the Obesity Health Alliance. ER is funded by the European Research Council (ERC) under the European Union’s Horizon 2020 research and innovation programme (Grant reference: PIDS, 803194) and the National Instit... | PMC10508026 |
Data Availability | The data that supports these findings will be available from the Open Science Framework repository upon publication (osf.io/kaju5 [ | PMC10508026 | ||
Declarations | PMC10508026 | |||
Ethics approval and consent to participate | Ethical approval was obtained from the University of Liverpool ethics committee (approval code: 4612), and informed consent was obtained from all participants before they took part in the study. | PMC10508026 | ||
Consent for publication | Consent for publication has been obtained. | PMC10508026 | ||
Competing interests | ER has previously received research funding from Unilever and the American Beverage Association for unrelated research projects. Other authors have no competing interests. | PMC10508026 | ||
Abbreviations | KilocaloriesSocioeconomic positionBody Mass IndexSubjective Social Status | PMC10508026 | ||
References | PMC10508026 | |||
Background | Lateral Elbow Tendinopathy | The OPTimisE intervention was developed to address uncertainty regarding the most effective physiotherapy treatment strategy for people with Lateral Elbow Tendinopathy (LET). | PMC10843168 | |
Objectives | To assess the feasibility of conducting a fully-powered randomised controlled trial (RCT) evaluating whether the OPTimisE intervention is superior to usual physiotherapy treatment for adults with LET. | PMC10843168 | ||
Design | A mixed-methods multi-centred, parallel pilot and feasibility RCT, conducted in three outpatient physiotherapy departments in the UK. | PMC10843168 | ||
Method | Patients were independently randomised 1:1 in mixed blocks, stratified by site, to the OPTimisE intervention or usual care. Outcomes were assessed using pre-defined feasibility progression criteria. | PMC10843168 | ||
Results | ADVERSE EVENTS | 50 patients were randomised (22 Female, 28 Male), mean age 48 years (range 27–75). Consent rate was 71% (50/70), fidelity to intervention 89% (16/18), attendance rate in the OPTimisE group 82% (55/67) vs 85% (56/66) in usual care, outcome measure completion 81% (39/48) at six-month follow-up. There were no related adve... | PMC10843168 | |
Conclusions | It is methodologically feasible to conduct a fully powered RCT comparing the clinical and cost-effectiveness of the OPTimisE intervention versus usual physiotherapy treatment. Considering the similar improvements observed in both groups, careful consideration is needed regarding the priority research question to be add... | PMC10843168 | ||
Introduction | elbow pain, Lateral elbow tendinopathy | TENNIS ELBOW | Lateral elbow tendinopathy (LET), also known as Tennis Elbow, is a common cause of elbow pain affecting sleep and basic daily activities, as well as sports, work and hobbies (The OPTimisE intervention was designed in consultation with patients and clinicians to reflect the current evidence base in a way that could be i... | PMC10843168 |
Method | PMC10843168 | |||
Trial design | We conducted a parallel two-arm, multi-centre pilot and feasibility randomised controlled trial across three sites. The detailed protocol has previously been published ( | PMC10843168 | ||
Feasibility outcomes | RECRUITMENT, SECONDARY | Our primary aim was to determine feasibility (criteria shown in Consent rate (number consented from those eligible after screening for inclusion/exclusion criteria)Intervention fidelity in the intervention group (measured as a binary outcome if participants were given the orthosis, taught the progressive exercise regim... | PMC10843168 | |
Participants | elbow pain, Maudsley, pain, PIS | TENNIS ELBOW | We piloted two methods of participant identification: screening of General Practice (GP) computer records and screening of referrals at physiotherapy sites. Those patients identified from GP records were sent a self-screening checklist and invitation letter to contact the trial team if they wished to be considered. The... | PMC10843168 |
Randomisation | Following assessment, we invited eligible patients to provide informed consent, complete baseline questionnaires and they were then randomised via an online service (Sealed Envelope™) using 1:1 allocation in mixed blocks or 2 and 4, stratified by treatment site. We also asked if they consented to be contacted about par... | PMC10843168 | ||
Interventions | orthosis, Epi-Hit®, pain | We allocated participants to receive either the OPTimisE intervention or usual physiotherapy care. We did not standardise usual care in this pragmatic trial but we recorded treatments received by participants, to allow comparison with the OPTimisE intervention. Physiotherapists providing usual care treatment had no res... | PMC10843168 | |
Blinding | Due to the nature of the interventions, neither participants nor physiotherapists could be blinded. Data analysis was not masked to allocation. | PMC10843168 | ||
Data collection | TENNIS ELBOW | We gathered patient-reported data using a questionnaire containing the recommended Core Outcome Set for LET (Patient-Rated Tennis Elbow Evaluation (PRTEE),Participants were given the choice of receiving questionnaires by post or online, using the Amplitude Pro-One™ system ( | PMC10843168 | |
Analytical methods | PMC10843168 | |||
Quantitative data analysis | Descriptive statistics were used to summarise the distribution of baseline variables across each of the randomisation groups. The continuous baseline variables (e.g. age) were reported with means and 95% confidence intervals (95% CI), if shown to be normally distributed, otherwise were reported with medians and Interqu... | PMC10843168 | ||
Qualitative interviews | PIS | RECRUITMENT | At least three months after randomisation, we sent a purposive sample of patients a PIS and invitation letter to take part in a qualitative interview. We followed this up by telephone or email to gain provisional consent and organise a mutually convenient time. Similarly, physiotherapists involved in the trial were app... | PMC10843168 |
Data management | Data were collected using a mix of paper and electronic methods. Where possible a patient ID number was used rather than identifiable information. Data from paper forms were transcribed into an electronic database in Microsoft Excel stored on secure NHS servers. Paper hard copies were stored at Derby CTSU and in the re... | PMC10843168 | ||
Results | We recruited the target of 50 patients (stipulated by the funder) within the allocated 12-month time-period. Baseline data are displayed in Summary of baseline data.The CONSORT diagram is shown in CONSORT diagram. | PMC10843168 | ||
Feasibility outcomes | RECRUITMENT | We enrolled the target of 50 participants six weeks ahead of schedule (as shown in Recruitment graph. | PMC10843168 | |
Secondary outcomes | orthosis, injuries | ADVERSE EVENTS, RECRUITMENT | Of the two patient recruitment methods, physiotherapy referral screening provided 49 participants, whereas only 1 participant was recruited from GP record screening (having identified 15 potentially eligible people).The outcome measure return rate at six weeks was 59% (66% online vs 36% paper); at 12 weeks was 65% (68%... | PMC10843168 |
Discussion | disability, NRS, pain | Our results suggest that it is feasible to conduct a full-scale trial to compare the clinical and cost-effectiveness of the OPTimisE intervention compared with usual NHS physiotherapy care. We successfully recruited to target ahead of schedule, but the number of eligible patients identified was lower than predicted bas... | PMC10843168 | |
Conclusion | It is methodologically feasible to conduct a fully powered RCT to compare the clinical and cost-effectiveness of the OPTimisE treatment protocol against usual physiotherapy treatment. However, both intervention and usual care groups showed similar improvements over time, questioning the importance of a future comparati... | PMC10843168 | ||
Ethics approval and consent to participate | Approvals were received from the Yorkshire & The Humber - Sheffield Research Ethics Committee (reference 21-YH-0121) and the UK Health Research Authority (reference 297637) on June 22nd | PMC10843168 | ||
Trial registration | Registered with the ISRCTN database 19/7/2021. | PMC10843168 | ||
Funding | BATEMAN | Marcus Bateman is funded by a | PMC10843168 | |
Patient and public involvement | orthosis | Patient volunteers were involved with the design of the OPTimisE intervention, selection of orthosis from a range of available products, generation of trial website frequently asked questions and review of trial resources. KC is a member of both the OPTimisE Patient and Public Involvement Group and Trial Management Gro... | PMC10843168 | |
Authors’ contributions | MB, CL, NF, BS, BV and DD were involved in the preliminary design and funding application. MB, CL, NF, BS, JCH, BV, JB, KC, AS and DD designed the trial protocol. All authors contributed to the conduct and management of the trial. MB, BS, CL, KC and JCH conducted the qualitative data analysis. MB and JB conducted the q... | PMC10843168 | ||
Declaration of competing interest | The authors have no conflicts of interest to declare.This paper presents independent research funded by the | PMC10843168 | ||
References | PMC10843168 | |||
Supplementary data | The following are the Supplementary data to this article. | PMC10843168 | ||
Multimedia component 1 | PMC10843168 | |||
1. Introduction | scaly, injury or cutaneous inflammation, SD | PATHOPHYSIOLOGY, INFLAMMATORY SKIN DISEASE, FACIAL SEBORRHEIC DERMATITIS, SEBORRHEIC DERMATITIS | Facial seborrheic dermatitis (SD) is an inflammatory skin disease characterized by erythematous and scaly lesions on the skin with high sebaceous gland activity. The yeast Seborrheic dermatitis (SD) is a chronic inflammatory skin disease characterized by erythematous, scaling, and indurated papules and plaques on the f... | PMC10531869 |
2. Results | A total of 115 patients were screened, of which 37 were enrolled into the study and 36 successfully completed the study ( | PMC10531869 | ||
2.1. Omiganan Does Not Show Clinical Improvement Compared to Placebo | DISEASE | Disease severity did not significantly decrease in the omiganan group compared to the placebo, as scored by SDASI (−1.5, CI −3.6 to 0.5, | PMC10531869 | |
2.2. Neither Omiganan Nor Ketoconazole Show Effects on Clinical Imaging Compared to Placebo | Erythema | ERYTHEMA | Erythema was comparable to the placebo in the omiganan group (−0.1682, 95% CI −2.9839 to 2.6475, | PMC10531869 |
2.3. Skin Barrier Function Improves upon Treatment with Ketoconazole | TEWL was not significantly reduced compared to the placebo at EOT for omiganan (−5.935, 95% CI −12.265 to 0.395, | PMC10531869 | ||
2.4. Ketoconazole but Not Omiganan Reduces Malassezia Abundances | Treatment with omiganan did not result in significant mycobial changes, with a −3.662% decrease in | PMC10531869 | ||
3. Discussion | SD, reduction of cutaneous inflammation | DISEASE, ATOPIC DERMATITIS, PATHOPHYSIOLOGY | The use of topical AMPs holds promise for the treatment of SD since both antifungal and antibacterial involvement has been previously established in this disease. In this randomized, comparator- and placebo-controlled clinical trial, the efficacy of 1.75% omiganan gel was compared to its vehicle and standard-of-care 2%... | PMC10531869 |
4. Materials and Methods | PMC10531869 | |||
4.1. Materials | ALDRICH | Chloroform (Honeywell, Charlotte, NC, USA), methanol (Biosolve, Valkenswaard, The Netherlands), heptane (LiChorSolv, Merck, Darmstadt, Germany), UPLC-grade isopropyl alcohol (Biosolve, Valkenswaard, The Netherlands), and ethanol (Biosolve, Valkenswaard, The Netherlands) were of HPLC grade or higher. Reagent-grade potas... | PMC10531869 | |
4.2. Study Design, Randomization, and Treatments | The trial was registered under ClinicalTrials.gov Identifier NCT03688971 and EudraCT number 2017-003106-41. The study was performed from November 2019 to January 2022 at the Centre for Human Drug Research (Leiden, The Netherlands) following the Declaration of Helsinki principles and after obtaining ethical approval fro... | PMC10531869 | ||
4.3. Patients | IGA, SD | Included patients exhibited mild-to-moderate facial SD, as defined by an Investigator’s Global Assessment (IGA) score of ≤2 at screening, without any other clinically significant conditions, recent tanning, or recent exposure to other SD treatments. Recent exposure was defined as two weeks for topical treatments and an... | PMC10531869 | |
4.4. Physician- and Patient-Reported Scoring | SEBORRHEIC DERMATITIS | SD severity was scored by the Seborrheic Dermatitis and Severity Index (SDASI) [ | PMC10531869 | |
4.5. Cutaneous Imaging | erythema | ERYTHEMA | Cross-polarized facial photography was performed using a VISIA-CR (Canfield Scientific, Parsippany-Troy Hills, NJ, USA). The erythema index was determined through ImageJ (version 1.51 h CITE) based on Yamamoto et al. [ | PMC10531869 |
4.6. Trans-Epidermal Water Loss Measurements | Trans-epidermal water loss (TEWL) was determined using an AquaFlux AF200 (Biox Systems Ltd., London, UK) after the subjects acclimatized to the controlled environmental conditions (humidity < 60%, temperature 22 ± 2 °C) for at least 15 min. TEWL was normalized with an additional measurement of non-lesion skin elsewhere... | PMC10531869 | ||
4.7. Lipidomics Analysis Using Sebum Measurements and Liquid Chromatography-Mass Spectrometry after Tape-Stripping | Sebum levels were measured in triplicate on adjacent skin using a Sebumeter SM815 (Courage and Khazaka, Cologne, Germany). The average of three measurements was calculated. For lipidomics, the stratum corneum was sampled with 5 subsequent polyphenylene sulfide tape strips (Nichiban, Tokyo, Japan), of which the first on... | PMC10531869 | ||
4.8. Microbial Profiling | SKIN, STERILE, LYSIS | Skin was swabbed for 10 s while constantly rotating using a sterile polyester-tipped applicator (Puritan, Guilford, ME, USA) soaked in 0.9% NaCl. Swabs were stored in DNA/RNA shield lysis buffer and beat beads (Zymo Research, Irvine, CA, USA) at −80 °C until analysis. Extraction, sequencing, and data generation were pe... | PMC10531869 | |
4.9. Malassezia Species Identification by Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry | Agar plates of 5.5 cm in diameter with modified Dixon agar medium (Tritium Microbiology B.V., Eindhoven, The Netherlands) were pressed against the skin for 20 min. Plates were transferred to the Alrijne Hospital (Leiden, The Netherlands) and cultured for up to 21 days at 33 °C. If mycological growth was observed, an is... | PMC10531869 | ||
4.10. Statistical Analysis | Calculations were performed using SAS version 9.4 (SAS Institute, Cary, NC, USA). Group size was based on a previous trial with omiganan with significant clinical effects rather than a formal power calculation [ | PMC10531869 | ||
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10531869 | ||
Author Contributions | Conceptualization, M.B.A.v.D., R.R., J.B., T.N.-v.d.K., G.L.F., M.S. and J.R.; methodology, M.B.A.v.D., R.R., T.N.-v.d.K., G.L.F., M.L.d.K. and J.R.; software, H.E.C.v.d.W.; formal analysis, M.L.d.K., H.E.C.v.d.W. and J.R.; investigation, M.B.A.v.D., T.N.-v.d.K., J.H., B.T., T.G., L.P., A.N., M.S. and J.R.; data curati... | PMC10531869 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and reviewed and approved by the Stichting Beoordeling Ethiek Biomedisch Onderzoek (IRB approval number: CHDR1733, NL62759.056.18, approved on 5 September 2018). | PMC10531869 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10531869 | ||
Data Availability Statement | The data that support the findings of this study are available from the corresponding author and/or trial sponsor upon reasonable request. | PMC10531869 | ||
Conflicts of Interest | Cutanea | MINOR | G.L.F. was an employee of Cutanea Life Sciences and involved in the design of the study and review and approval of the final manuscript. Comments made by G.L.F. were minor and did not change the message of the manuscript. The other authors have no conflict of interest to declare. | PMC10531869 |
References | ADVERSE EVENTS | (((The change in relative abundance of (Demographics of the study population and adverse events. | PMC10531869 | |
Background | Blinding drugs through simulation techniques is an important means to control the subjective bias of investigators and subjects. However, clinical trials face significant challenges in the placebo production of drugs, and many trials cannot be double-blinded. | PMC10636892 | ||
Objective | BLIND | This study was conducted to ascertain the consistency between non-blind and blind evaluation results in clinical trials and to pioneer strategies to control information bias, particularly in trials where double-blinding is not feasible. | PMC10636892 | |
Methods | Diabetic Foot (IWGDF), was used as the primary, DFIs | DIABETIC FOOT INFECTIONS, INFECTIOUS DISEASE | In this investigation, a randomized controlled trial (RCT) studying diabetic foot infections (DFIs) was utilized as a representative case. In this trial, the grading of DFIs, as per guidelines by the Infectious Disease Society of America (IDSA) and International Working Group on Diabetic Foot (IWGDF), was used as the p... | PMC10636892 |
Results | Five subjects were excluded due to the quality of photos or the lack of post-treatment visits. The post-treatment IDSA/IWGDF grading results were compared in 11 subjects (experimental group=6, control group=5), and the consistency test showed inconsistent results between the non-blinded and center reading blinded evalu... | PMC10636892 | ||
Conclusions | The study highlighted that evaluations from non-blinded site investigators may potentially exaggerate the efficacy of the experimental group and that deep wounds can present challenges for observation via center-reading photos. These findings underline the vital necessity for objective assessment in open clinical trial... | PMC10636892 | ||
Trial registration | ChiCTR2000041443. Registered on December 2020 | PMC10636892 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07652-y. | PMC10636892 | ||
Keywords | PMC10636892 | |||
Introduction | EVENT, BLIND | The application of the most reliable evidence to address individual clinical issues underpins the core principle of evidence-based medicine [However, due to the particularity of certain interventions, it becomes challenging to blind participants and investigators in some clinical trials. Recent investigations have high... | PMC10636892 | |
Methods | PMC10636892 | |||
Designs | trauma, DFIs | DIABETIC FOOT INFECTIONS | A multicenter RCT on diabetic foot infections (DFIs) was taken as an example. This trial evaluated the efficacy and safety of a Chinese patent medicine. Patients with DFI, aged between 18 and 75 years, and IDSA/IWGDF grade 2 were included [There is a greater risk of using a placebo control for patients in this trial. F... | PMC10636892 |
Setting | This was an exploratory study, and we randomly selected only about 10% of the completed clinical trial subjects for blinded and unblinded evaluations ( | PMC10636892 | ||
Non-blinded investigators | infection, fever, pain | INFECTION, APPENDIX | The IDSA/IWGDF grading of DFI was determined and recorded by a non-blinded investigator at the study center for post-treatment patients. A note was made as to whether the subject had local pressure or pain, local fever, systemic symptoms, or symptoms of infection at the time of photography. For the randomly selected su... | PMC10636892 |
Blinded investigators | center-reading | BLIND | Based on the “Study Center Grading Results Evaluation Form,” the center-reading investigators made independent determinations back-to-back in a blind state. A third center-reading investigator made a second determination if two center-reading investigators made inconsistent determinations. | PMC10636892 |
Evaluation | IDSA/IWGDF grading: Assessing the IDSA/IWGDF grading of non-blinded and blinded investigators. | PMC10636892 | ||
Quality control and assurance | Previously, we provided better training to the investigators involved in this study’s blinded and unblinded clinical assessment. We believe that the main source of the difference between blinded and unblinded researchers’ evaluation of post-treatment outcomes is evaluation bias, which is the effect of unblinded personn... | PMC10636892 | ||
Statistical analysis | An independent statistician will carry out statistical analysis using the SPSS 25 software. All statistical tests will be two-sided, | PMC10636892 | ||
Results | PMC10636892 | |||
Results for blinded evaluation | Among the 16 randomly enrolled patients, one was excluded due to a lack of post-treatment follow-ups, and 4 were unable to be analyzed as the central reader could not discern the deeper parts of the wounds from the photographs. The randomization and follow-up process for patients is illustrated in Fig. Flow chart for s... | PMC10636892 | ||
Considerations for blinded evaluation | In open clinical trials where wound observation serves as the primary efficacy measure, we recommend the appointment of an independent blinded investigator at each trial site, accompanied by the implementation of a series of standard operating procedures (SOPs) for blinded evaluation. The ensuing considerations for bli... | PMC10636892 | ||
Personnel roles and training | BLIND | We advise establishing clearly delineated roles among the research team, which may include treatment investigators, blinded evaluation investigators, research nurses, quality control officers, medication administrators, and documentation managers.The investigator responsible for efficacy evaluation remains blinded thro... | PMC10636892 | |
Management of participants | Given the external nature of the treatment employed in this study, achieving absolute blinding of participants was challenging. First, both treatment investigators and research nurses should be strictly instructed not to reveal specific treatment protocol details to patients. Secondly, to minimize the potential for int... | PMC10636892 | ||
Management of experimental medications | EVENT | It is recommended that a medication manager be appointed within the study team, responsible for the receipt, storage, maintenance, distribution, and retrieval of medications. The medications should be stored in opaque medicine cabinets. Prior to prescribing, the treatment investigator must obtain a randomization number... | PMC10636892 | |
Collection of efficacy indicators | infection, purulent | INFECTION, EPITHELIALIZATION | Though the wounds in this study were documented using digital photography and analyzed with image analysis software, factors such as environment, operational procedure, and patient positioning may influence the quality of the images. As such, a blinded assessment investigator should be assigned to document wound healin... | PMC10636892 |
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