scholarly journals Refining clinical trial inclusion criteria to optimize the standardized response mean of the CMTPedS

2020 ◽  
Vol 7 (9) ◽  
pp. 1713-1715
Author(s):  
Kayla M. D. Cornett ◽  
Manoj P. Menezes ◽  
Paula Bray ◽  
Rosemary R. Shy ◽  
Isabella Moroni ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inclusion Criteria ◽  
Standardized Response Mean

scholarly journals Single-bone versus both-bone plating of unstable paediatric both-bone forearm fractures. A randomized controlled clinical trial

2021 ◽  
Author(s):  
Mohamed Khaled ◽  
Amr A. Fadle ◽  
Ahmed Khalil Attia ◽  
Andrew Sami ◽  
Abdelkhalek Hafez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Operative Time ◽  
Forearm Fractures ◽  
Inclusion Criteria ◽  
Fracture Union ◽  
Exclusion Criteria ◽  
Bone Fixation ◽  
Fixation Group ◽  
Significant Difference ◽  
Single Bone

Abstract Purpose This clinical trial compares the functional and radiological outcomes of single-bone fixation to both-bone fixation of unstable paediatric both-bone forearm fractures. Methods This individually randomized two-group parallel clinical trial was performed following the Consolidated Standards of Reporting Trials (CONSORT) statement at a single academic tertiary medical centre with an established paediatric orthopaedics unit. All children aged between nine and 15 years who presented to the emergency department at Assiut university with unstable diaphyseal, both-bone forearm fractures requiring surgical intervention between November 1, 2018, and February 28, 2020, were screened for eligibility against the inclusion and exclusion criteria. Inclusion criteria were diaphyseal unstable fractures defined as shaft fractures between the distal and proximal metaphyses with an angulation of > 10°, and/or malrotation of > 30°, and/or displacement > 10 mm after attempted closed reduction. Exclusion criteria included open fractures, Galeazzi fractures, Monteggia fractures, radial head fractures, and associated neurovascular injuries. Patients who met the inclusion criteria were randomized to either the single-bone fixation group (intervention) or the both-bone fixation group (control). Primary outcomes were forearm range of motion and fracture union, while secondary outcomes were forearm function (price criteria), radius re-angulation, wrist and elbow range of motion, and surgical time Results A total of 50 children were included. Out of these 50 children, 25 were randomized to either arm of the study. All children in either group received the treatment assigned by randomization. Fifty (100%) children were available for final follow-up at six months post-operatively. The mean age of single-bone and both-bone fixation groups was 11.48 ± 1.93 and 13 ± 1.75 years, respectively, with a statistically significant difference (p = 0.006). There were no statistically significant differences in gender, laterality, affection of the dominant hand, or mode of trauma between single-bone and both-bone fixation groups. All patients in both groups achieved fracture union. There mean radius re-angulation of the single-bone fixation groups was 5.36 ± 4.39 (0–20) degrees, while there was no radius re-angulation in the both-bone fixation group, with a statistically significant difference (p < 0.001). The time to union in the single-bone group was 6.28 ± 1.51 weeks, while the time to union in the both-bone fixation group was 6.64 ± 1.75 weeks, with no statistically significant difference (p = 0.44). There were no infections or refractures in either group. In the single-bone fixation group, 24 (96%) patients have regained their full forearm ROM (loss of ROM < 15°), while only one (4%) patient lost between 15 and 30° of ROM. In the both-bone fixation group, 23 (92%) patients have regained their full forearm ROM (loss of ROM < 15°), while only two (8%) patients lost between 15 and 30° of ROM. There was no statistically significant difference between groups in loss of forearm ROM (p = 0.55). All patients in both groups regained full ROM of their elbow and wrist joints. On price grading, 24 (96%) and 23 (92%) patients who underwent single bone fixation and both-bone fixation scored excellent, respectively. Only one (4%) patient in the single-bone fixation group and two (8%) patients in the both-bone fixation group scored good, with no statistically significant difference in price score between groups (p = 0.49). The majority of the patients from both groups had no pain on the numerical pain scale; 22 (88%) patients in the single-bone fixation group and 21 (84%) patients in the both-bone fixation groups, with no statistically significant difference between groups (p = 0.38). The single-bone fixation group had a significantly shorter mean operative time in comparison to both-bones plating (43.60 ± 6.21 vs. 88.60 ± 10.56 (min); p < 0.001). Conclusion Single-bone ulna open reduction and plate fixation and casting are safe and had a significantly shorter operative time than both-bone fixation. However, single-bone ORIF had a higher risk radius re-angulation, alas clinically acceptable. Both groups had equally excellent functional outcomes, forearm ROM, and union rates with no complications or refractures. Long-term studies are required.

scholarly journals Canadian Recommendations for Clinical Trials of Pharmacologic Interventions in Rheumatoid Arthritis: Inclusion Criteria and Study Design: Table 1.

2011 ◽  
Vol 38 (10) ◽  
pp. 2095-2104 ◽  
Author(s):  
JACOB KARSH ◽  
EDWARD C. KEYSTONE ◽  
BOULOS HARAOUI ◽  
J. CARTER THORNE ◽  
JANET E. POPE ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Disease Activity ◽  
Study Design ◽  
New Drugs ◽  
Nominal Group ◽  
Consensus Method ◽  
Inclusion Criteria ◽  
Design Features

Objective.Current clinical trial designs for pharmacologic interventions in rheumatoid arthritis (RA) do not reflect the innovations in RA diagnosis, treatment, and care in countries where new drugs are most often used. The objective of this project was to recommend revised entry criteria and other study design features for RA clinical trials.Methods.Recommendations were developed using a modified nominal group consensus method. Canadian Rheumatology Research Consortium (CRRC) members were polled to rank the greatest challenges to clinical trial recruitment in their practices. Initial recommendations were developed by an expert panel of rheumatology trialists and other experts. A scoping study methodology was then used to examine the evidence available to support or refute each initial recommendation. The potential influence of CRRC recommendations on primary outcomes in future trials was examined. Recommendations were finalized using a consensus process.Results.Recommendations for clinical trial inclusion criteria addressed measures of disease activity [Disease Activity Score 28 using erythrocyte sedimentation rate (DAS28-ESR) > 3.2 PLUS ≥ 3 tender joints using 28-joint count (TJC28) PLUS ≥ 3 swollen joint (SJC28) OR C-reactive protein (CRP) or ESR > upper limit of normal PLUS ≥ 3 TJC28 PLUS ≥ 3 SJC28], functional classification, disease classification and duration, and concomitant RA treatments. Additional recommendations regarding study design addressed rescue strategies and longterm extension.Conclusion.There is an urgent need to modify clinical trial inclusion criteria and other study design features to better reflect the current characteristics of people living with RA in the countries where the new drugs will be used.

scholarly journals Strategi monitoring kepatuhan penggunaan antiretroviral pre-exposure prophilaxis pada pasangan serodiscordant

2019 ◽  
Vol 35 (1) ◽  
pp. 29
Author(s):  
Ni Kadek Diah Purnamayanti ◽  
Nurma Yuni Pari Usemahu ◽  
Fatih Haris M ◽  
Marina Kristi Layun R
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Monitoring Strategy ◽  
Inclusion Criteria ◽  
Serodiscordant Couple ◽  
Data Bases ◽  
Social Commitment ◽  
Homosexual Orientation ◽  
Exposure Prophylaxis ◽  
Level Monitoring

Monitoring strategy of antiretroviral pre-exposure prophylaxis adherence among serodiscordant couple  Antiretroviral pre-exposure prophylaxis (PrEP) has been recommended as HIV prevention but poor medical adherence can cause suboptimal therapy. This study explored the strategies of monitoring PrEP adherence among the serodiscordant couples. This systematic review based on 4 data bases (Scopus, Pubmed, Ebsco and Sage Journal), included clinical trial studies articles between 2013-2018, in English, and available in full-text. Papers, which not met the inclusion criteria, will be excluded. Keywords used in this study are ‘serodiscordant couple’ AND ‘method’ OR ‘strategy’ OR ‘approach’ AND ‘pre-exposure prophylaxis intention’ OR ‘pre-exposure prophylaxis adherence’. This study discovered various strategies applied based on the type of delivering process, the variance of dose, and variance of preference of the couple. Preference of PrEP dose and type of application related to heterosexual or homosexual orientation and their social commitment. The paper explains the advantage of M-health and biomarker level monitoring. 

Abstract 167: Factors Influencing the Decision to Accept or Decline to Participate in Clinical Research: A Qualitative Study

2018 ◽  
Vol 11 (suppl_1) ◽  
Author(s):  
Fiona Ecarnot ◽  
Romain Chopard ◽  
Francois Schiele ◽  
Nicolas Meneveau
Keyword(s):  
Clinical Trial ◽  
Qualitative Study ◽  
Clinical Research ◽  
Emotional Health ◽  
Research Participation ◽  
Two Dimensions ◽  
Trial Participation ◽  
Main Concern ◽  
Inclusion Criteria ◽  
General Behaviour

Introduction: Guidelines rely on evidence-based data, and clinical research is key to providing this evidence-base. Yet the factors that influence a patient’s decision to participate (or not) in research remain poorly documented. We aimed to investigate the factors that determine the decision to accept or decline clinical trial participation, using a qualitative approach. Methods: Single-centre, qualitative study using semi-directive interviews with patients (pts) who had been invited to participate in a randomized clinical trial and who had given their decision. Both pts who refused and pts who accepted were included. There were no inclusion criteria; all pts who met the inclusion criteria of the selected trial and had been approached for consent were eligible. Pts also completed a questionnaire rating 16 statements examining reasons for accepting or declining trial entry. Verbatim from the interviews were analysed using a grounded theory (GT) approach. Results: To date, 14 patients have been interviewed; average age 75±7 years. Two pts did not know if they were currently participating in a trial or not; 1 said he was not participating although he had provided consent. From a GT perspective, the main concern of patients does not appear to be the question of research participation, but rather the fact of being sick, and their overriding preoccupation is how to return to their previous state of wellbeing and overcome the current acute episode. Regarding the decision to participate in research, the main themes that arose were: (1) the positive value of the trial for the patient (benefitting from the intervention; interest in receiving closer and/or more regular follow-up due to trial participation), although some pts clearly do not understand the concept of randomization; (2) the level of engagement in the process of care (some pts do not bother to read the information given to them, but just accept what is proposed without question, while others decline immediately without reading trial information). Two dimensions emerge, namely physical and emotional health, with a spectrum ranging from fragile to robust. Where the patient is situated on this spectrum appears to influence their attitude towards research participation. Conclusions: The decision to participate (or not) in clinical research appears to be more related to the patient’s general behaviour and attitude when sick, rather than any specific trial-related constraints or advantages. The level of comprehension of pts who have been through the consent process casts a doubt on the “informed” character of the consent.

Cetuximab, fluorouracil (5-FU), cisplatin, and docetaxel as first-line treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Interim results of a randomized phase II clinical trial (CeFCiD).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17021-e17021
Author(s):  
Maren Knoedler ◽  
Andreas Dietz ◽  
Thomas Christoph Gauler ◽  
Viktor Gruenwald ◽  
Jan Stoehlmacher ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Interim Analysis ◽  
Standard Dose ◽  
Response Rates ◽  
Inclusion Criteria ◽  
First Line ◽  
Randomized Phase Ii ◽  
Toxicity Analysis ◽  
Dose Reductions ◽  
Clinical Trial Information

e17021 Background: This study investigates efficacy and toxicity of docetaxel added to cetuximab, cisplatin and 5-FU for patients with R/M SCCHN. We here report a planned second interim analysis to compare response rates between arms in order to decide on continuing to full accrual. Methods: Inclusion criteria were: stage III/IV R/M SCCHN and ECOG 0-1. Patients were randomized to arm A: cetuximab (standard dose) plus a maximum of 6 cycles of docetaxel (40 mg/m², day 1+8), cisplatin (40 mg/m², day 1+8) and 5-FU (2000 mg/m², day 1+8) or to arm B: cetuximab (standard dose), cisplatin (100 mg/m², day 1) and 5-FU (1000 mg/m², day 1-4). Treatment was administered until progression or intolerability. The endpoint of this analysis was RR. Results: A first interim analysis for toxicity after treatment of 20 patients per arm revealed more hematologic and gastrointestinal grade III/IV toxicities in the experimental arm. Therefore dose reductions of cisplatin from 40 to 30 mg/m² and 5-FU from 2,000 to 1,000 mg/m² had been introduced. A secondary toxicity analysis with 40 patients per arm observed reduced treatment related toxicities. Currently 100 patients could be assessed for response: arm A: 82 % male, median age 58 years, arm B: 82 % male, median age 60 years. Best overall RR was 41 % (3 CR, 18 PR) in arm A compared to 45 % (4 CR, 19 PR) in arm B. The DCR was 75 % in arm A and 80 % in arm B. Conclusions: After introducing dose reductions toxicity is manageable. Comparable response rates were seen in both arms. CeFCiD continues per protocol for evaluation of the primary endpoint PFS. Enrollment is estimated to be completed in Aug 2013. Clinical trial information: CeFCiD-1108.

scholarly journals Clinical Trial Risk in Chronic Obstructive Pulmonary Disease: The Effects of Drug Class and Inclusion Criteria

Respiration ◽  
2015 ◽  
Vol 91 (1) ◽  
pp. 79-86 ◽  
Author(s):  
Jeffrey T.Y. Tam ◽  
Jayson L. Parker ◽  
Demetri Anastasopulos ◽  
Meyer S. Balter
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Clinical Trial ◽  
Pulmonary Disease ◽  
Drug Class ◽  
Chronic Obstructive ◽  
Inclusion Criteria ◽  
Obstructive Pulmonary Disease

Emotional and physical support during labor for primiparouse women

2011 ◽  
Vol 26 (S2) ◽  
pp. 1102-1102
Author(s):  
L.H. Nasab ◽  
R. Shahoie ◽  
F. Zaheri ◽  
F. Ranaie
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Side Effect ◽  
Labor Pain ◽  
Inclusion Criteria ◽  
Control Data ◽  
Convenience Sample ◽  
Physical Support ◽  
And Control ◽  
Primiparous Women

BackgroundThe experience of labor varies markedly from women to Women. While medications can help women cope with the pain of labor, they usually come with side effects that women did not expect or want. There are many non medical ways to cope with the pain which has not side effect.The purpose of this study was to evaluate the effect of emotional and physical support during labor for primiparouse women.MethodIn this clinical trial study, convenience sample of 80 primiparous women who fulfilled the inclusion criteria was recruited from one hospital in Sanandaj (Center of Kurdistan provenice), Iran. They were randomly divided in Two groups (Case and Control). Data were collected from May to October 2008 using a demographic form and Visual Analoge Scale(VAS).ResultThe study revealed that emotional and physical support during labor cause women has better tolerance of pain. Furthermore, comparison pain intensity among two groups in dillatation 8 and 10 cm was statically significant (p < 0/03& p = 0/000).ConclusionEmotional and physical support during labor can be considered as a non pharmacological therapeutic method to reduce labor pain and decrease side effect of drugs. In addition, education and using of this method increases women satisfying from labor and natural delivery and to make better experience of motherhood.

scholarly journals Antibacterial efficacy of photodynamic therapy in the disinfection of root canals - Integrative literature review

2020 ◽  
Vol 33 (2) ◽  
pp. 147-158
Author(s):  
Danyllo Guimarães Morais Barros ◽  
Diego Filipe Bezerra Silva ◽  
Gustavo Araújo de Freitas ◽  
Gabriella De Vasconcelos Neves ◽  
Jozinete Vieira Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Methylene Blue ◽  
Exposure Time ◽  
Irradiation Time ◽  
Light Sources ◽  
Antibacterial Efficacy ◽  
Review Of The Literature ◽  
Inclusion Criteria ◽  
Bacterial Populations ◽  
Root Canals

To evaluate the antibacterial efficacy of hotodynamic Therapy (PDT) in root canal (RC) disinfection. An integrative review of the literature was performed in diferents databases. It was selected articles published between January 2014 and January 2018, in Portuguese, English or Spanish languages, which evaluated, in a clinical trial, the antibacterial efficacy of PDT in RC disinfection. The sample consisted of 05 articles that met all the inclusion criteria, which analyzed aspects such as: sample; photosensitizer and exposure time; light source, wavelength, potency, energy and time of emission; and results. Most of the studies used single-rooted teeth and methylene blue photosensitizer with pre-irradiation time ranging from 1 to 5 minutes. The LED and the laser were the light sources used, with exposure time ranging from 40 to 240 seconds; power from 60 mW to 1000 mW; power density from 2 to 4 mW / cm2; energy of 4 to 9,6 J; and dose from 1.2 mJ / cm2 to 129 J / cm2. It can be concluded that, despite the heterogeneity of the protocols, there was a reduction in the bacterial populations responsible for RC infections, and it may be a supporting technique in endodontic therapy.

scholarly journals Searching clinical trial registries in interventional physical therapy systematic reviews: A Pilot Cross-sectional Analysis

2018 ◽  
Author(s):  
Alaa Abou Khzam
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Systematic Reviews ◽  
Trial Registry ◽  
Inclusion Criteria ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Clinical Trial Registries ◽  
Sectional Analysis

Background. Studies with positive findings are more likely to be published compared to those with negative findings. Therefore the latter studies are often disregarded in systematic reviews. This causes an overestimation of a treatment effect size which leads to a misinterpretation of the evidence. Searching clinical trial registries in systematic reviews is a useful source to retrieve unpublished clinical trials leading to the reduction of publication bias. Previous studies in the literature reported inconsistent searching of clinical trial registries in systematic reviews published in several medical fields. Searching clinical trial registries in physical therapy is still unknown. The aim of this cross-sectional analysis is to evaluate the extent of clinical trial registry searching in physical therapy interventional systematic reviews. Methods. Systematic reviews published between January 2017 and January 2018 were retrieved from five reputable physical therapy journals. Interventional systematic reviews that were coherent with the inclusion criteria were included in the analysis. Results. The search yielded 40 systematic reviews. Among these 19 were interventional systematic reviews as well as being consistent with the inclusion criteria and thus were considered for the analysis. After reviewing their search methodology, only two reviews (10.5%) reported searching at least one clinical trial registry. Discussion. The results of this study suggest poor searching of clinical trial registries in physical therapy systematic reviews. Due to the limitations of this study, further research analyzing large samples of interventional physical therapy systematic reviews is required.

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