Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement.

PubMed

Kanji, Salmaan; Hayes, Meghan; Ling, Adam; Shamseer, Larissa; Chant, Clarence; Edwards, David J; Edwards, Scott; Ensom, Mary H H; Foster, David R; Hardy, Brian; Kiser, Tyree H; la Porte, Charles; Roberts, Jason A; Shulman, Rob; Walker, Scott; Zelenitsky, Sheryl; Moher, David

2015-07-01

Transparent reporting of all research is essential for assessing the validity of any study. Reporting guidelines are available and endorsed for many types of research but are lacking for clinical pharmacokinetic studies. Such tools promote the consistent reporting of a minimal set of information for end users, and facilitate knowledge translation of research. The objective of this study was to create a guideline to assist in the transparent and complete reporting of clinical pharmacokinetic studies. Preliminary content to be considered was identified from a systematic search of the literature and regulatory documents. Stakeholders were identified to participate in a modified Delphi exercise and a virtual meeting to generate consensus for items considered essential in the reporting of clinical pharmacokinetic studies. The proposed checklist was pilot tested on 100 recently published clinical pharmacokinetic studies. Overall and itemized compliance with the proposed guidance was determined for each study. Sixty-eight stakeholders from nine countries consented to participate. Four rounds of a modified Delphi survey and a series of small virtual meetings were required to generate consensus for a 24-item checklist considered to be essential to the reporting of clinical pharmacokinetic studies. When applied to the 100 most recently published clinical pharmacokinetic studies, 45 were determined to be compliant with at least 80 % of the checklist items. Explanatory text was prepared using examples of compliant reporting from these and other relevant studies. The reader's ability to judge the validity of pharmacokinetic research can be greatly compromised by the incomplete reporting of study information. Using consensus methods, we have developed a tool to guide transparent and accurate reporting of clinical pharmacokinetic studies. Endorsement and implementation of these guidelines by researchers, clinicians and journals would promote more consistent reporting of these studies and allow for better assessment of utility for clinical applications.

78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-01

...] Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the...

Use of platelet-rich plasma in the treatment of rotator cuff pathology. What has been scientifically proven?

PubMed

Miranda, I; Sánchez-Alepuz, E; Lucas, F J; Carratalá, V; González-Jofre, C A

To analyze the current scientific and/or clinical evidence supporting the use of platelet-rich plasma (PRP) in the treatment of rotator cuff pathology. After a systematic review in PubMed, studies assessing PRP efficacy in the treatment of rotator cuff pathology published since 2013 to date were identified. Data were grouped based on type of study (laboratory, clinical or meta-analysis); accordingly study design, pathology treated and clinical outcomes were summarized. Thirty five articles have been analyzed: 10 laboratory studies, 17 clinical assays and 8 meta-analyses. While laboratory studies report positive or partially positive results for the use of PRP, 70.6% of clinical studies and 75% of meta-analysis found no statistically significant differences between the PRP group and the control group. The positive results of laboratory studies do not translate well to clinical practice. There is no concordance among the few positive results reported in the clinical studies, and even some contradictory effects have been reported. There is no solid scientific and/or clinical evidence supporting the use of PRP in the treatment of rotator cuff pathology in routine clinical practice. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

Preclinical to Clinical Translation of Studies of Transcranial Direct-Current Stimulation in the Treatment of Epilepsy: A Systematic Review

PubMed Central

Regner, Gabriela G.; Pereira, Patrícia; Leffa, Douglas T.; de Oliveira, Carla; Vercelino, Rafael; Fregni, Felipe; Torres, Iraci L. S.

2018-01-01

Epilepsy is a chronic brain syndrome characterized by recurrent seizures resulting from excessive neuronal discharges. Despite the development of various new antiepileptic drugs, many patients are refractory to treatment and report side effects. Non-invasive methods of brain stimulation, such as transcranial direct current stimulation (tDCS), have been tested as alternative approaches to directly modulate the excitability of epileptogenic neural circuits. Although some pilot and initial clinical studies have shown positive results, there is still uncertainty regarding the next steps of investigation in this field. Therefore, we reviewed preclinical and clinical studies using the following framework: (1) preclinical studies that have been successfully translated to clinical studies, (2) preclinical studies that have failed to be translated to clinical studies, and (3) clinical findings that were not previously tested in preclinical studies. We searched PubMed, Web of Science, Embase, and SciELO (2002–2017) using the keywords “tDCS,” “epilepsy,” “clinical trials,” and “animal models.” Our initial search resulted in 64 articles. After applying inclusion and exclusion criteria, we screened 17 full-text articles to extract findings about the efficacy of tDCS, with respect to the therapeutic framework used and the resulting reduction in seizures and epileptiform patterns. We found that few preclinical findings have been translated into clinical research (number of sessions and effects on seizure frequency) and that most findings have not been tested clinically (effects of tDCS on status epilepticus and absence epilepsy, neuroprotective effects in the hippocampus, and combined use with specific medications). Finally, considering that clinical studies on tDCS have been conducted for several epileptic syndromes, most were not previously tested in preclinical studies (Rasmussen's encephalitis, drug resistant epilepsy, and hippocampal sclerosis-induced epilepsy). Overall, most studies report positive findings. However, it is important to underscore that a successful preclinical study may not indicate success in a clinical study, considering the differences highlighted herein. Although most studies report significant findings, there are still important insights from preclinical work that must be tested clinically. Understanding these factors may improve the evidence for the potential use of this technique as a clinical tool in the treatment of epilepsy. PMID:29623027

The case for introducing pre-registered confirmatory pharmacological pre-clinical studies.

PubMed

Kiwanuka, Olivia; Bellander, Bo-Michael; Hånell, Anders

2018-05-01

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

The Ontology of Clinical Research (OCRe): An Informatics Foundation for the Science of Clinical Research

PubMed Central

Sim, Ida; Tu, Samson W.; Carini, Simona; Lehmann, Harold P.; Pollock, Brad H.; Peleg, Mor; Wittkowski, Knut M.

2013-01-01

To date, the scientific process for generating, interpreting, and applying knowledge has received less informatics attention than operational processes for conducting clinical studies. The activities of these scientific processes — the science of clinical research — are centered on the study protocol, which is the abstract representation of the scientific design of a clinical study. The Ontology of Clinical Research (OCRe) is an OWL 2 model of the entities and relationships of study design protocols for the purpose of computationally supporting the design and analysis of human studies. OCRe’s modeling is independent of any specific study design or clinical domain. It includes a study design typology and a specialized module called ERGO Annotation for capturing the meaning of eligibility criteria. In this paper, we describe the key informatics use cases of each phase of a study’s scientific lifecycle, present OCRe and the principles behind its modeling, and describe applications of OCRe and associated technologies to a range of clinical research use cases. OCRe captures the central semantics that underlies the scientific processes of clinical research and can serve as an informatics foundation for supporting the entire range of knowledge activities that constitute the science of clinical research. PMID:24239612

ClinicalTrials.gov

MedlinePlus

... Terms and Conditions Disclaimer ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted ... world. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of ...

Orthodontic treatment in periodontitis‐susceptible subjects: a systematic literature review

PubMed Central

Lindsten, Rune; Slotte, Christer; Bjerklin, Krister

2016-01-01

Abstract The aim is to evaluate the literature for clinical scientific data on possible effects of orthodontic treatment on periodontal status in periodontitis‐susceptible subjects. A systematic literature review was performed on studies in English using PubMed, MEDLINE, and Cochrane Library central databases (1965‐2014). By manually searching reference lists of selected studies, we identified additional articles; then we searched these publications: Journal of Periodontology, Periodontology 2000, Journal of Clinical Periodontology, American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, International Journal of Periodontics & Restorative Dentistry, and European Journal of Orthodontics. Search terms included randomized clinical trials, controlled clinical trials, prospective and retrospective clinical studies, case series >5 patients, periodontitis, orthodontics, alveolar bone loss, tooth migration, tooth movement, orthodontic extrusion, and orthodontic intrusion. Only studies on orthodontic treatment in periodontally compromised dentitions were included. One randomized controlled clinical trial, one controlled clinical trial, and 12 clinical studies were included. No evidence currently exists from controlled studies and randomized controlled clinical trials, which shows that orthodontic treatment improves or aggravates the status of periodontally compromised dentitions. PMID:29744163

Undergraduate nursing students' experience related to their clinical learning environment and factors affecting to their clinical learning process.

PubMed

Arkan, Burcu; Ordin, Yaprak; Yılmaz, Dilek

2018-03-01

Clinical education is an essential part of nursing education. The purpose of this study was to explore nurse students' experiences related to cinical learning environments, factors effecting to clinical learning process. Descriptive qualitative design was used in this study, and data were collected from 2nd class nursing student (n = 14). The study took the form of in-depth interviews between August-October 2015. The qualitative interviews were analyzed by using simple content analysis. Data were analyzed manually. Experiences nurse students are described five themes. The themes of the study are (1) effecting persons to clinical learning, (2) educational atmosphere, (3) students' personal charactering, (4) the impact of education in school, and (5) students' perceptions related to clinical learning. Participants stated that they experienced many difficulties during clinical learning process. All students importantly stated that nurse teacher is very effecting to clinical learning. This study contributes to the literature by providing data on beginner nursing student' experiences about clinical learning process. The data of this present study show to Turkish nursing student is affecting mostly from persons in clinical learning. The data of this present study will guide nurse teacher when they plan to interventions to be performed to support student during clinical learning process. Copyright © 2017 Elsevier Ltd. All rights reserved.

A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM.

PubMed

Yamamoto, Keiichi; Ota, Keiko; Akiya, Ippei; Shintani, Ayumi

2017-06-01

The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) can be used for new drug application studies as well as secondarily for creating a clinical research data warehouse to leverage clinical research study data across studies conducted within the same disease area. However, currently not all clinical research uses Clinical Data Acquisition Standards Harmonization (CDASH) beginning in the set-up phase of the study. Once already initiated, clinical studies that have not utilized CDASH are difficult to map in the SDTM format. In addition, most electronic data capture (EDC) systems are not equipped to export data in SDTM format; therefore, in many cases, statistical software is used to generate SDTM datasets from accumulated clinical data. In order to facilitate efficient secondary use of accumulated clinical research data using SDTM, it is necessary to develop a new tool to enable mapping of information for SDTM, even during or after the clinical research. REDCap is an EDC system developed by Vanderbilt University and is used globally by over 2100 institutions across 108 countries. In this study, we developed a simulated clinical trial to evaluate a tool called REDCap2SDTM that maps information in the Field Annotation of REDCap to SDTM and executes data conversion, including when data must be pivoted to accommodate the SDTM format, dynamically, by parsing the mapping information using R. We confirmed that generating SDTM data and the define.xml file from REDCap using REDCap2SDTM was possible. Conventionally, generation of SDTM data and the define.xml file from EDC systems requires the creation of individual programs for each clinical study. However, our proposed method can be used to generate this data and file dynamically without programming because it only involves entering the mapping information into the Field Annotation, and additional data into specific files. Our proposed method is adaptable not only to new drug application studies but also to all types of research, including observational and public health studies. Our method is also adaptable to clinical data collected with CDASH at the beginning of a study in non-standard format. We believe that this tool will reduce the workload of new drug application studies and will support data sharing and reuse of clinical research data in academia. Copyright © 2017 Elsevier Inc. All rights reserved.

[Features of Clinical Register of Chinese Medicine and Pharmacy Based on ClinicalTrials.gov. (USA)].

PubMed

Lu, Peng-fei; Liao, Xing; Xie, Yan-ming; Wang, Zhi-guo

2015-11-01

In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.

A Study of Clinically Related Open Source Software Projects

PubMed Central

Hogarth, Michael A.; Turner, Stuart

2005-01-01

Open source software development has recently gained significant interest due to several successful mainstream open source projects. This methodology has been proposed as being similarly viable and beneficial in the clinical application domain as well. However, the clinical software development venue differs significantly from the mainstream software venue. Existing clinical open source projects have not been well characterized nor formally studied so the ‘fit’ of open source in this domain is largely unknown. In order to better understand the open source movement in the clinical application domain, we undertook a study of existing open source clinical projects. In this study we sought to characterize and classify existing clinical open source projects and to determine metrics for their viability. This study revealed several findings which we believe could guide the healthcare community in its quest for successful open source clinical software projects. PMID:16779056

Using Clinical Gait Case Studies to Enhance Learning in Biomechanics

ERIC Educational Resources Information Center

Chester, Victoria

2011-01-01

Clinical case studies facilitate the development of clinical reasoning strategies through knowledge and integration of the basic sciences. Case studies have been shown to be more effective in developing problem-solving abilities than the traditional lecture format. To enhance the learning experiences of students in biomechanics, clinical case…

Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.

PubMed

Kudrin, Alex; Knezevic, Ivana; Joung, Jeewon; Kang, Hye-Na

2015-01-01

The objective of this paper is to provide considerations based on comprehensive case studies important for regulatory evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) with a special emphasis on clinical aspects. Scientific principles from WHO Guidelines on SBPs were used as a basis for the exercise. Working groups consisted of regulators, manufacturers and academia. The following topics were discussed by the working groups: clinical criteria for biosimilarity, extrapolation approach and the overall regulatory decision making process. In order to determine typical pitfalls in the design of a SBP clinical programme and evaluate the gap of knowledge, amongst different industry and regulatory stakeholders on the appraisal of the data arising from SBP clinical studies, we have presented two fictional but realistic clinical case studies. The first case consists of the fictional development programme for an infliximab SBP candidate. The second case describes clinical studies proposed for a fictional rituximab SBP candidate. In the first scenario a highly similar quality profile has been taken forward into clinical studies whereas there was an important residual difference in functional attributes for the rituximab SBP candidate. These case studies were presented at the WHO implementation workshop for the WHO guidelines on evaluation of similar biotherapeutic products held in Seoul, Republic of Korea, in May 2014. The goal was to illustrate the interpretation of the clinical data arising from studies with SBP candidates and elicit knowledge gaps in clinical assessment. This paper reflects the outcome of the exercise and discussions held in Seoul and offers an analysis of the case studies as a learning opportunity on clinical development and evaluation of SBPs. Copyright © 2014 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Evaluation systems for clinical governance development: a comparative study.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-01-01

Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

Recommendations for Clinical Pathology Data Generation, Interpretation, and Reporting in Target Animal Safety Studies for Veterinary Drug Development.

PubMed

Siska, William; Gupta, Aradhana; Tomlinson, Lindsay; Tripathi, Niraj; von Beust, Barbara

Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines that address such studies provide recommendations for clinical pathology testing but occasionally contain outdated analytes and do not take into account interspecies physiologic differences that affect the practical selection of appropriate clinical pathology tests. Additionally, strong emphasis is often placed on statistical analysis and use of reference intervals for interpretation of test article-related clinical pathology changes, with limited attention given to the critical scientific review of clinically, toxicologically, or biologically relevant changes. The purpose of this communication from the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology is to provide current recommendations for clinical pathology testing and data interpretation in target animal safety studies and thereby enhance the value of clinical pathology testing in these studies.

Building a semantic web-based metadata repository for facilitating detailed clinical modeling in cancer genome studies.

PubMed

Sharma, Deepak K; Solbrig, Harold R; Tao, Cui; Weng, Chunhua; Chute, Christopher G; Jiang, Guoqian

2017-06-05

Detailed Clinical Models (DCMs) have been regarded as the basis for retaining computable meaning when data are exchanged between heterogeneous computer systems. To better support clinical cancer data capturing and reporting, there is an emerging need to develop informatics solutions for standards-based clinical models in cancer study domains. The objective of the study is to develop and evaluate a cancer genome study metadata management system that serves as a key infrastructure in supporting clinical information modeling in cancer genome study domains. We leveraged a Semantic Web-based metadata repository enhanced with both ISO11179 metadata standard and Clinical Information Modeling Initiative (CIMI) Reference Model. We used the common data elements (CDEs) defined in The Cancer Genome Atlas (TCGA) data dictionary, and extracted the metadata of the CDEs using the NCI Cancer Data Standards Repository (caDSR) CDE dataset rendered in the Resource Description Framework (RDF). The ITEM/ITEM_GROUP pattern defined in the latest CIMI Reference Model is used to represent reusable model elements (mini-Archetypes). We produced a metadata repository with 38 clinical cancer genome study domains, comprising a rich collection of mini-Archetype pattern instances. We performed a case study of the domain "clinical pharmaceutical" in the TCGA data dictionary and demonstrated enriched data elements in the metadata repository are very useful in support of building detailed clinical models. Our informatics approach leveraging Semantic Web technologies provides an effective way to build a CIMI-compliant metadata repository that would facilitate the detailed clinical modeling to support use cases beyond TCGA in clinical cancer study domains.

An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

PubMed

Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

2013-11-01

To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

Exploring the screening capacity of the Fear of Cancer Recurrence Inventory-Short Form for clinical levels of fear of cancer recurrence.

PubMed

Fardell, Joanna E; Jones, Georden; Smith, Allan Ben; Lebel, Sophie; Thewes, Belinda; Costa, Daniel; Tiller, Kerry; Simard, Sébastien; Feldstain, Andrea; Beattie, Sara; McCallum, Megan; Butow, Phyllis

2018-02-01

Fear of cancer recurrence (FCR) is a common concern among cancer survivors. Identifying survivors with clinically significant FCR requires validated screening measures and clinical cut-offs. We evaluated the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) clinical cut-off in 2 samples. Level of FCR in study 1 participants (from an Australian randomized controlled trial: ConquerFear) was compared with FCRI-SF scores. Based on a biopsychosocial interview, clinicians rated participants as having nonclinical, subclinical, or clinical FCR. Study 2 participants (from a Canadian FCRI-English validation study) were classified as having clinical or nonclinical FCR by using the semistructured clinical interview for FCR (SIFCR). Receiver operating characteristic analyses evaluated the screening ability of the FCRI-SF against clinician ratings (study 1) and the SIFCR (study 2). In study 1, 167 cancer survivors (mean age: 53 years, SD = 10.1) participated. Clinicians rated 43% as having clinical FCR. In study 2, 40 cancer survivors (mean age: 68 years, SD = 7.0) participated; 25% met criteria for clinical FCR according to the SIFCR. For both studies 1 and 2, receiver operating characteristic analyses suggested a cut-off ≥22 on the FCRI-SF identified cancer survivors with clinical levels of FCR with adequate sensitivity and specificity. Establishing clinical cut-offs on FCR screening measures is crucial to tailoring individual care and conducting rigorous research. Our results suggest using a higher cut-off on the FCRI-SF than previously reported to identify clinically significant FCR. Continued evaluation and validation of the FCRI-SF cut-off is required across diverse cancer populations. Copyright © 2017 John Wiley & Sons, Ltd.

Out of sight, out of mind? Does terminating the physical presence of a geriatric consultant in the community clinic reduce the implementation rate for geriatric recommendations.

PubMed

Freud, Tamar; Punchik, Boris; Biderman, Aya; Peleg, Roni; Kagan, Ella; Barzak, Alex; Press, Yan

2016-01-01

To assess the effect of moving the geriatric consultation from the primary care clinic to another setting, on the rate of implementation of geriatric recommendations by family physicians. A retrospective review of the computerized medical records of elderly patients in four primary care clinics. The rate of implementation of geriatric recommendations was compared between clinics in which a geriatric consultant was physically present (control clinics) and a clinic where the consultation took place elsewhere (study clinic). In addition, the results of the present study were compared to a previous study in which the geriatric consultation was carried out in the study clinic and the family doctor was an active participant. 127 computerized files were reviewed in the study clinic and 133 in the control clinics. The mean age of the patients was 81.1±6.3 years and 63.1% were women. The overall implementation of geriatric recommendations by family doctors in the study clinic was 55.9%, a statistically significant decrease compared to the previous study where the rate was 73.9% (p<0.0001). In contrast, there was no change in the implementation rate in the control clinics at 65.0% in the present study and 59.9% in the previous one (p=0.205). Direct, person-to-person contact between the geriatric consultant and the family doctor has a beneficial effect on the implementation of geriatric recommendations. This should be considered by healthcare policy makers when planning geriatric services in the community. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

PubMed

Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

2018-03-01

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

ClinicalTrials.gov, stem cells and 'pay-to-participate' clinical studies.

PubMed

Turner, Leigh

2017-09-01

Numerous US businesses that engage in direct-to-consumer advertising of stem cell interventions that are not US FDA-approved also recruit clients by listing 'pay-to-participate' studies listed on ClinicalTrials.gov . Individuals considering enrolling in such studies and NIH officials responsible for overseeing the database need to be aware that some businesses are using the registry to promote unapproved stem cell interventions that study subjects are charged to receive. Inclusion of such studies in ClinicalTrials.gov reveals that the database needs better screening tools. In particular, screening should evaluate whether studies submitted to the registry have been reviewed and permitted to proceed by the FDA in the case of clinical studies requiring FDA clearance in addition to institutional review board approval.

Exploring Factors Affecting Undergraduate Medical Students' Study Strategies in the Clinical Years: A Qualitative Study

ERIC Educational Resources Information Center

Al Kadri, Hanan M. F.; Al-Moamary, Mohamed S.; Elzubair, Margaret; Magzoub, Mohi Eldien; AlMutairi, Abdulrahman; Roberts, Christopher; van der Vleuten, Cees

2011-01-01

The aim of this study is to explore the effects of clinical supervision, and assessment characteristics on the study strategies used by undergraduate medical students during their clinical rotations. We conducted a qualitative phenomenological study at King Saud Bin Abdulaziz University for Health Sciences, College of Medicine, Riyadh, Saudi…

Midwifery students' experiences of learning clinical skills in Iran: a qualitative study.

PubMed

Ahmadi, Golnoosh; Shahriari, Mohsen; Keyvanara, Mahmood; Kohan, Shahnaz

2018-03-09

A qualitative study was used. Midwifery students from three universities in Iran participated. The study used a convenience sample of eighteen students. Data for this study was collected using semi-structured interviews (N=12) and focus groups (N=6). Data were recorded on a digital audio recorder and then transcribed. The qualitative data were analyzed using a content analysis approach. Six broad themes emerged from the analysis: Limited opportunities to experience skills, difficulties with course plan gaps, need for creating a supportive clinical environment, learning drives, confusion between different methods, and stress in the clinical setting. Short verbatim quotations from the participants were presented to provide evidence for the interpretation of data. The findings of this study have provided a clear picture of the factors and mechanisms involved in learning clinical skills by midwifery students. This study showed that students had some difficulties and concerns during learning of clinical midwifery skills. The findings of this study suggest that midwifery educators conduct further studies to tackle these issues in clinical skills learning. The findings of this study are subject to some limitations which are discussed.

Health literacy and usability of clinical trial search engines.

PubMed

Utami, Dina; Bickmore, Timothy W; Barry, Barbara; Paasche-Orlow, Michael K

2014-01-01

Several web-based search engines have been developed to assist individuals to find clinical trials for which they may be interested in volunteering. However, these search engines may be difficult for individuals with low health and computer literacy to navigate. The authors present findings from a usability evaluation of clinical trial search tools with 41 participants across the health and computer literacy spectrum. The study consisted of 3 parts: (a) a usability study of an existing web-based clinical trial search tool; (b) a usability study of a keyword-based clinical trial search tool; and (c) an exploratory study investigating users' information needs when deciding among 2 or more candidate clinical trials. From the first 2 studies, the authors found that users with low health literacy have difficulty forming queries using keywords and have significantly more difficulty using a standard web-based clinical trial search tool compared with users with adequate health literacy. From the third study, the authors identified the search factors most important to individuals searching for clinical trials and how these varied by health literacy level.

Nursing students' perspectives on clinical instructors' effective teaching strategies: A descriptive study.

PubMed

Valiee, Sina; Moridi, Glorokh; Khaledi, Shahnaz; Garibi, Fardin

2016-01-01

An important factor contributing to the quality of clinical education is instructors' teaching performance. The aim of this study was to identify clinical instructors' most effective teaching strategies from nursing and midwifery students' perspectives. This was a descriptive cross-sectional study. All third- and fourth-year bachelor's nursing and midwifery students studying at the Nursing and Midwifery Faculty of Kurdistan University of Medical Sciences were recruited to the study by using the census method. The study instrument consisted of a demographic questionnaire and the self-report 30-item Clinical Instructors' Effective Teaching Strategies Inventory. The SPSS v.16.0 was used for data analysis. The most effective teaching strategies of clinical instructors from nursing and midwifery students' perspectives were respectively 'treating students, clients, and colleagues with respect' and 'being eager for guiding students and manage their problems'. Clinical instructors need to be eager for education and also be able to establish effective communication with students. Empowering clinical instructors in specialized and technical aspects of clinical education seems necessary. Copyright © 2015 Elsevier Ltd. All rights reserved.

Nurses’ Clinical Judgment Development: A Qualitative Research in Iran

PubMed Central

Seidi, Jamal; Alhani, Fatemeh; Salsali, Mahvash

2015-01-01

Background: Clinical judgment development is necessary because it leads to appropriate nursing diagnoses, clinical decision-making and health promotion. Objectives: In this study we explored the process of Iranian nurses’ development in clinical judgment. Patients and Methods: This qualitative study was conducted in 2013 at hospitals of Kurdistan University of Medical Sciences, located in the Sanandaj city of Iran. The data were collected based on semi-structured interviews and the study included 24 participants. Data analysis was carried out concurrently with data collection using the grounded theory method. Results: The study participants’ main concern was ‘being non-professional in clinical judgment’. In response to this concern, they were struggling for gaining professional autonomy, striving for integrating clinical judgment skills, scrambling to make effective educational interventions and striving for professional and inter professional collaboration in clinical judgment. The core category was ‘struggling for becoming professional in clinical judgment development’. When nurses were supported professionally, they were able to develop their professional clinical judgment. Conclusions: The findings of this study provided critical information about nurses’ professionalization in clinical judgment. Accordingly, the participants adopted different strategies to develop their clinical judgment ability. Integrating these strategies into nursing theory and clinical education can improve nurses’ clinical judgment ability. PMID:26473075

Designing clinical trials for amblyopia

PubMed Central

Holmes, Jonathan M.

2015-01-01

Randomized clinical trial (RCT) study design leads to one of the highest levels of evidence, and is a preferred study design over cohort studies, because randomization reduces bias and maximizes the chance that even unknown confounding factors will be balanced between treatment groups. Recent randomized clinical trials and observational studies in amblyopia can be taken together to formulate an evidence-based approach to amblyopia treatment, which is presented in this review. When designing future clinical studies of amblyopia treatment, issues such as regression to the mean, sample size and trial duration must be considered, since each may impact study results and conclusions. PMID:25752747

Clinical Natural Language Processing in languages other than English: opportunities and challenges.

PubMed

Névéol, Aurélie; Dalianis, Hercules; Velupillai, Sumithra; Savova, Guergana; Zweigenbaum, Pierre

2018-03-30

Natural language processing applied to clinical text or aimed at a clinical outcome has been thriving in recent years. This paper offers the first broad overview of clinical Natural Language Processing (NLP) for languages other than English. Recent studies are summarized to offer insights and outline opportunities in this area. We envision three groups of intended readers: (1) NLP researchers leveraging experience gained in other languages, (2) NLP researchers faced with establishing clinical text processing in a language other than English, and (3) clinical informatics researchers and practitioners looking for resources in their languages in order to apply NLP techniques and tools to clinical practice and/or investigation. We review work in clinical NLP in languages other than English. We classify these studies into three groups: (i) studies describing the development of new NLP systems or components de novo, (ii) studies describing the adaptation of NLP architectures developed for English to another language, and (iii) studies focusing on a particular clinical application. We show the advantages and drawbacks of each method, and highlight the appropriate application context. Finally, we identify major challenges and opportunities that will affect the impact of NLP on clinical practice and public health studies in a context that encompasses English as well as other languages.

Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

PubMed

Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

2016-01-28

Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov had their results published at least 30 months after study completion. The registration of these observational studies allowed searching other sources (results posted at ClinicalTrials.gov and sponsor website) and obtaining results for half of unpublished studies and 93% of the total target number of participants.

Educating Parents About Pediatric Research: Children and Clinical Studies Website Qualitative Evaluation.

PubMed

Marceau, Lisa D; Welch, Lisa C; Pemberton, Victoria L; Pearson, Gail D

2016-07-01

A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information. © The Author(s) 2015.

Non-clinical studies required for new drug development - Part I: early in silico and in vitro studies, new target discovery and validation, proof of principles and robustness of animal studies.

PubMed

Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Freitas, C S; Marcon, R; Schwanke, R C; Siqueira, J M; Calixto, J B

2016-10-24

This review presents a historical overview of drug discovery and the non-clinical stages of the drug development process, from initial target identification and validation, through in silico assays and high throughput screening (HTS), identification of leader molecules and their optimization, the selection of a candidate substance for clinical development, and the use of animal models during the early studies of proof-of-concept (or principle). This report also discusses the relevance of validated and predictive animal models selection, as well as the correct use of animal tests concerning the experimental design, execution and interpretation, which affect the reproducibility, quality and reliability of non-clinical studies necessary to translate to and support clinical studies. Collectively, improving these aspects will certainly contribute to the robustness of both scientific publications and the translation of new substances to clinical development.

Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair

PubMed Central

Mithoefer, Kai; Saris, Daniel B.F.; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J.; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats

2011-01-01

Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project. PMID:26069574

Evaluating Creative Thinking of Rn-Bsn Students in the Course of Clinical Case Study and Practicum

ERIC Educational Resources Information Center

Ku, Ya-Lie

2015-01-01

This case study evaluated creative thinking of RN-BSN students in the course of clinical case study and practicum. Study design used quantitative and qualitative evaluations of creative thinking of RN-BSN students by triangulation method in the course of clinical case study and practicum. Sixty RN-BSN students self-perceived the changing levels of…

The distribution of outcomes research papers across clinical journals.

PubMed

Goldsack, Jennifer; McLaughlin, Chris; Bristol, Mirar N; Loeb, Alex; Bergey, Meredith; Sonnad, Seema S

2011-06-01

This study examines the distribution of health outcomes research (HOR) studies in the clinical literature by clinical areas and journal impact factor. The authors reviewed 535 journals and divided the sample into higher and lower impact journals across four clinical area. Mann-Whitney and Kruskal-Wallis tests were used to examine differences across four categories of outcomes research articles published, specifically the incidence of articles in higher versus lower impact journals and differences across clinical areas. All high-impact journals published more safety and quality articles than process assessment, quality of life, or cost analysis studies. The number of each type of outcomes research study published was highly variable across all clinical areas. Only arthritis and outcomes research journals showed statistically significant differences between higher versus lower impact journals. Authors may benefit from considering these differences in their clinical specialty area when deciding where to submit HOR studies.

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

PubMed

Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J

2015-10-01

Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. Published by Elsevier Inc.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jacobson, L. O.; Doyle, M.

Abstracts are provided for presentations in these areas: studies in immunology; studies in molecular biology; experimental and clinical studies of cell differentiation; studies on the blood; general metabolic studies; problems in scanning; clinical and experimental studies on the effects of radiation; and studies with high energy radiations.

The fate of prospective spine studies registered on www.ClinicalTrials.gov.

PubMed

Ohnmeiss, Donna D

2015-03-01

There has been concern expressed about research ethics with respect to not fully reporting data collected during clinical studies. One site available for all clinical trials is ClinicalTrials.gov. The original purpose of this site was to facilitate patients seeking a trial for the treatment of their particular condition. The internationally available site offers general information about the study, sponsor name, principal investigator, patient selection criteria, enrollment goal, study design, outcome measures, participating centers, initiation date, date posted, date completed, and other pertinent data. The site can be used to identify studies conducted for a particular condition or intervention. The purpose of this study was to investigate the fate of spine-related studies registered on www.ClinicalTrials.gov, with particular focus on the publication rate of completed trials. Analysis and classification of clinical studies posted on an international research registry Web page and literature search for related publications. Not applicable. The primary outcome measure was publication of the study registered on ClinicalTrials.gov. Multiple searches were conducted on ClinicalTrials.gov Web site to identify studies related to commonly treated spinal conditions, including herniated disc, degenerative disc disease, stenosis, and spondylolisthesis. Studies related to tumors, fractures, or that included nonspine conditions were not included. For studies classified as completed more than 18 months before this review, literature searches were conducted to determine if the results of the study had been published and factors related to publication. The author has no financial conflict related to this work. There were 263 spine-related studies identified from searches on the ClinicalTrials.gov site. Data on the site had the studies classified as follows: 72 completed, 70 active, not recruiting (generally indicates collecting follow-up data), 74 recruiting, 11 recruiting by invitation, 13 not yet recruiting, 18 terminated, 4 withdrawn, and 1 suspended. Among the 72 studies indicated to be completed, 28 (38.9%) have been published. The mean time to publish was 27.9 months from the date of completion. Among unpublished studies, the mean length of time from study completion to the preparation of this article was 62.0 months. There was no difference in the likelihood of publication based on the geographic region of study origin or whether the study was registered before or after initiation. There were statistically significant relationships between the publication rate and the funding type as well as the research type (p<.05) with industrial-funded studies and those evaluating devices having a lower publication rate and those that were funded by a federal agency and comparing surgery to nonoperative care had the highest publication rates. Although the 38.9% publication rate for spine-related studies found in this study appears low, it is in line with other studies reporting a 22.8% publication rate for arthroplasty trials and 43.2% for orthopedic trauma trials. In addition to ClinicalTrials.gov Web site fulfilling its original goal of providing patients information about clinical studies, it can also provide a means of tracking publication of prospective studies, changes to protocols, matching publication content to posted study design, and others and raise queries concerning the reasons for not publishing what appear to be well-designed studies. The posting of spine studies before initiation can increase transparency and ability to evaluate clinical trials in spine. Copyright © 2015 Elsevier Inc. All rights reserved.

Is There Value in Having Radiology Provide a Second Reading in Pediatric Orthopaedic Clinic?

PubMed

Natarajan, Vivek; Bosch, Patrick; Dede, Ozgur; Deeney, Vincent; Mendelson, Stephen; Ward, Timothy; Brooks, Maria; Kenkre, Tanya; Roach, James

2017-06-01

The Joint Commission on Accreditation of Healthcare Organizations specifically mandates the dual interpretation of musculoskeletal radiographs by a radiologist in addition to the orthopaedist in all hospital-based orthopaedic clinics. Previous studies have questioned the utility of this practice. The purpose of this study was to further investigate the clinical significance of having the radiologist provide a second interpretation in a hospital-based pediatric orthopaedic clinic. A retrospective review was performed of all patients who had plain radiographs obtained in the pediatric orthopaedic clinic at an academic children's hospital over a 4-month period. For each radiographic series, the orthopaedist's note and the radiology interpretation were reviewed and a determination was made of whether the radiology read provided new clinically useful information and/or a new diagnosis, whether it recommended further imaging, or if it missed a diagnosis that was reflected in the orthopaedist's note. The hospital charges associated with the radiology read for each study were also quantified. The charts of 1570 consecutive clinic patients who were seen in the pediatric orthopaedic clinic from January to April, 2012 were reviewed. There were 2509 radiographic studies performed, of which 2264 had both a documented orthopaedist's note and radiologist's read. The radiologist's interpretation added new, clinically important information in 1.0% (23/2264) of these studies. In 1.7% (38/2264) of the studies, it was determined that the radiologist missed the diagnosis or clinically important information that could affect treatment. The total amount of the professional fees charged for the radiologists' interpretations was $87,362. On average, the hospital charges for each occurrence in which the radiologist's read provided an additional diagnosis or clinically important information beyond the orthopaedist's note were $3798. The results of this study suggest that eliminating the requirement to have the radiologist interpret radiographs in the pediatric orthopaedic clinic would have few clinical consequences. Level III-This is a diagnostic retrospective cohort study.

Poststroke Seizures and Epilepsy: Clinical Studies and Animal Models

PubMed Central

Kelly, Kevin M.

2002-01-01

Poststroke seizures and epilepsy have been described in numerous clinical studies for many years. Most studies are retrospective in design, include relatively small numbers of patients, have limited periods of follow-up, and report a diversity of findings. Well-designed clinical trials and population studies in the recent past addressed several critical clinical issues and generated important findings regarding the occurrence of poststroke seizures and epilepsy. In contrast, the pathophysiologic events of injured brain that establish poststroke epileptogenesis are not well understood, and animal modeling has had limited development. Reviews of several important clinical studies and animal models that hold promise for a better understanding of poststroke epileptogenesis are presented. PMID:15309107

Clinical application of antidepressant pharmacogenetics: considerations for the design of future studies.

PubMed

Fabbri, Chiara; Serretti, Alessandro

2018-06-12

A frustrating inertia has affected the development of clinical applications of antidepressant pharmacogenetics and personalized treatments of depression are still lacking 20 years after the first findings. Candidate gene studies provided replicated findings for some polymorphisms, but each of them shows at best a small effect on antidepressant efficacy and the cumulative effect of different polymorphisms is unclear. Further, no candidate was immune by at least some negative studies. These considerations give rise to some concerns about the clinical benefits of currently available pharmacogenetic tests since they are based on the results of candidate gene studies. Clinical guidelines in fact suggest that only polymorphisms that alter cytochrome 2D6 or 2C19 enzymatic activity probably provide useful clinical indications, while variants in genes involved in antidepressant pharmacodynamics have no recommended clinical applications. The present review discusses possible strategies to facilitate the identification of genetic biomarkers with clinical usefulness in guiding antidepressant treatments. These include analysis methods for the study of the polygenic/omnigenic nature of antidepressant response, the prioritization of polymorphisms on the basis of functional considerations, the incorporation of clinical-demographic predictors in pharmacogenetic studies (e.g. mixed polygenic and clinical risk scores), the application of methodological improvements to the design of future studies in order to maximize the comparability of results and improve power. Copyright © 2018. Published by Elsevier B.V.

Competence of novice nurses: role of clinical work during studying

PubMed Central

Manoochehri, H; Imani, E; Atashzadeh-Shoorideh, F; Alavi-Majd, A

2015-01-01

Aim: Clinical competence is to carry out the tasks with excellent results in a different of adjustments. According to various studies, one of the factors influencing clinical competence is work experience. This experience affects the integrity of students' learning experience and their practical skills. Many nursing students practice clinical work during their full-time studying. The aim of this qualitative research was to clarify the role of clinical work during studying in novice nurses' clinical competence. Methods: This qualitative content analysis performed with the conventional approach. All teaching hospitals of Hormozgan University of Medical Sciences selected as the research environment. To collect data, deep and semi-structured interviews, presence in the scene and manuscripts used. To provide feedback for the next release and the capacity of the data, interviews were transcribed verbatim immediately. Results: 45 newly-graduated nurses and head nurses between 23 and 40 with 1 to 18 years of experience participated in the study. After coding all interviews, 1250 original codes were derived. The themes extracted included: task rearing, personality rearing, knowledge rearing, and profession rearing roles of clinical work during studying. Conclusion: Working during studying can affect performance, personality, knowledge, and professional perspectives of novice nurses. Given the differences that may exist in clinical competencies of novice nurses with and without clinical work experience, it is important to pay more attention to this issue and emphasize on their learning in this period. PMID:28316703

What is different about medical students interested in non-clinical careers?

PubMed Central

2013-01-01

Background The proportion of medical school graduates who pursue careers other than full-time clinical practice has increased in some countries as the physician’s role has evolved and diversified with the changing landscape of clinical practice and the advancement of biomedicine. Still, past studies of medical students’ career choices have focused on clinical specialties and little is known about their choice of non-clinical careers. The present study examined backgrounds, motivation and perceptions of medical students who intended non-clinical careers. Methods A questionnaire was administered to students at six Korean medical schools distributed across all provinces in the nation. The questionnaire comprised 40 items on respondents’ backgrounds, their motivation for and interest in the study of medicine, their perceptions of medical professions, and their career intentions. Data was analyzed using various descriptive and inferential statistics. Results In total, 1,388 students returned the questionnaire (60% response rate), 12.3% of whom intended non-clinical careers (i.e., basic sciences, non-clinical medical fields, and non-medical fields). Those who planned non-clinical careers were comparable with their peers in their motivation for studying medicine and in their views of medical professions, but they were less interested in the study of medicine (P < 0.01). The two groups also differed significantly on their perceptions of what was uninteresting about the study of medicine (P < 0.01). The two groups were comparable in gender and entry-level ratios but their distributions across ages and years of study differed significantly (P < 0.01). A majority of respondents agreed with the statements that “it is necessary for medical school graduates to pursue non-clinical careers” and that “medical schools need to offer programs that provide information on such careers.” Still, our finding indicates that medical school curricula do not address such needs sufficiently. Conclusions Our study found some differences in backgrounds and perceptions of the study of medicine in medical students interested in non-clinical careers from their peers. Future studies are suggested to enhance our understanding of medical students” choice of non-clinical careers. PMID:23731551

How good is "evidence" from clinical studies of drug effects and why might such evidence fail in the prediction of the clinical utility of drugs?

PubMed

Naci, Huseyin; Ioannidis, John P A

2015-01-01

Promising evidence from clinical studies of drug effects does not always translate to improvements in patient outcomes. In this review, we discuss why early evidence is often ill suited to the task of predicting the clinical utility of drugs. The current gap between initially described drug effects and their subsequent clinical utility results from deficits in the design, conduct, analysis, reporting, and synthesis of clinical studies-often creating conditions that generate favorable, but ultimately incorrect, conclusions regarding drug effects. There are potential solutions that could improve the relevance of clinical evidence in predicting the real-world effectiveness of drugs. What is needed is a new emphasis on clinical utility, with nonconflicted entities playing a greater role in the generation, synthesis, and interpretation of clinical evidence. Clinical studies should adopt strong design features, reflect clinical practice, and evaluate outcomes and comparisons that are meaningful to patients. Transformative changes to the research agenda may generate more meaningful and accurate evidence on drug effects to guide clinical decision making.

Cautionary tales in the interpretation of observational studies of effects of clinical interventions.

PubMed

Scott, I A; Attia, J

2017-02-01

Observational studies of the effectiveness of clinical interventions are proliferating as more 'real-world' clinical data (so called 'big data') are gathered from clinical registries, administrative datasets and electronic health records. While well-conducted randomised controlled trials (RCT) remain the scientific standard in assessing the efficacy of clinical interventions, well-designed observational studies may add to the evidence base of effectiveness in situations where RCT are of limited value or very difficult to perform. Rather than dismissing observational studies, we need to determine what circumstances may justify doing an observational study and when the study is sufficiently rigorous to be considered reasonably trustworthy. This article proposes criteria by which users of the literature might make such determinations. © 2016 Royal Australasian College of Physicians.

Pre-admission criteria and pre-clinical achievement: Can they predict medical students performance in the clinical phase?

PubMed

Salem, Raneem O; Al-Mously, Najwa; AlFadil, Sara; Baalash, Amal

2016-01-01

Various factors affect medical students' performance during clinical phase. Identifying these factors would help in mentoring weak students and help in selection process for residency programmes. Our study objective is to evaluate the impact of pre-admission criteria, and pre-clinical grade point average (GPA) on undergraduate medical students' performance during clinical phase. This study has a cross-sectional design that includes fifth- and sixth-year female medical students (71). Data of clinical and pre-clinical GPA in medical school and pre-admission to medical school tests scores were collected. A significant correlation between clinical GPA with the pre-clinical GPA was observed (p < 0.05). Such significant correlation was not seen with other variables under study. A regression analysis was performed, and the only significant predictor of students clinical performance was the pre-clinical GPA (p < 0.001). However, no significant difference between students' clinical and pre-clinical GPA for both cohorts was observed (p > 0.05). Pre-clinical GPA is strongly correlated with and can predict medical students' performance during clinical years. Our study highlighted the importance of evaluating the academic performances of students in pre-clinical years before they move into clinical years in order to identify weak students to mentor them and monitor their progress.

Student's perceptions of effective clinical teaching revisited.

PubMed

Kelly, Claudette

2007-11-01

Despite a wealth of research on clinical teaching, the criteria for determining what constitutes effective clinical teaching remain poorly defined [Cholowski, K., 2002. Nursing students' and clinical educators' perceptions of characteristics of effective clinical educators in an Australian university school of nursing. Journal of Advanced Nursing 39 (5), 412-420]. This paper reports on two studies exploring second and third year nursing student's perceptions of effective clinical teaching over 14 years (1989-2003). The aim of the inquiry was to compare student's perceptions in diploma and baccalaureate programs within existing clinical contexts. This research used a generative approach to elicit learner's views of what teacher characteristics and contextual influences impact them in clinical settings. A convenience sample of 30 students at the end of second and third years volunteered to be interviewed in-depth for each study. The first study was conducted in a diploma program, whereas in the second study all but a few students were elected to complete a four year baccalaureate nursing degree. Findings from both studies are remarkably consistent. Students in both studies rated teacher knowledge as most important followed by feedback and communication skills. Teacher knowledge appeared critical in four areas: as it pertains to the clinical setting, the curriculum, the learner and teaching/learning theory. How well students perceived that they were accepted by staff, student-teacher ratios and peer support also appeared to impact student's views of effective clinical teaching. This research has implications for employment and evaluation practices for teachers in applied fields such as nursing. The study raises questions about the recent trend toward temporary employment of clinical teachers and in the separation of academic and clinical roles of nurse educators.

A multicenter study: how do medical students perceive clinical learning climate?

PubMed

Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

2016-01-01

The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students' perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students' interactions in clinical settings, self-realization, mood, students' intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve clinical learning climate.

Developing an International Register of Clinical Prediction Rules for Use in Primary Care: A Descriptive Analysis

PubMed Central

Keogh, Claire; Wallace, Emma; O’Brien, Kirsty K.; Galvin, Rose; Smith, Susan M.; Lewis, Cliona; Cummins, Anthony; Cousins, Grainne; Dimitrov, Borislav D.; Fahey, Tom

2014-01-01

PURPOSE We describe the methodology used to create a register of clinical prediction rules relevant to primary care. We also summarize the rules included in the register according to various characteristics. METHODS To identify relevant articles, we searched the MEDLINE database (PubMed) for the years 1980 to 2009 and supplemented the results with searches of secondary sources (books on clinical prediction rules) and personal resources (eg, experts in the field). The rules described in relevant articles were classified according to their clinical domain, the stage of development, and the clinical setting in which they were studied. RESULTS Our search identified clinical prediction rules reported between 1965 and 2009. The largest share of rules (37.2%) were retrieved from PubMed. The number of published rules increased substantially over the study decades. We included 745 articles in the register; many contained more than 1 clinical prediction rule study (eg, both a derivation study and a validation study), resulting in 989 individual studies. In all, 434 unique rules had gone through derivation; however, only 54.8% had been validated and merely 2.8% had undergone analysis of their impact on either the process or outcome of clinical care. The rules most commonly pertained to cardiovascular disease, respiratory, and musculoskeletal conditions. They had most often been studied in the primary care or emergency department settings. CONCLUSIONS Many clinical prediction rules have been derived, but only about half have been validated and few have been assessed for clinical impact. This lack of thorough evaluation for many rules makes it difficult to retrieve and identify those that are ready for use at the point of patient care. We plan to develop an international web-based register of clinical prediction rules and computer-based clinical decision support systems. PMID:25024245

A multicenter study: how do medical students perceive clinical learning climate?

PubMed

Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

2016-01-01

Background The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students' perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Methods Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). Results The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. Conclusion The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students' interactions in clinical settings, self-realization, mood, students' intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve clinical learning climate.

Towards Data Value-Level Metadata for Clinical Studies.

PubMed

Zozus, Meredith Nahm; Bonner, Joseph

2017-01-01

While several standards for metadata describing clinical studies exist, comprehensive metadata to support traceability of data from clinical studies has not been articulated. We examine uses of metadata in clinical studies. We examine and enumerate seven sources of data value-level metadata in clinical studies inclusive of research designs across the spectrum of the National Institutes of Health definition of clinical research. The sources of metadata inform categorization in terms of metadata describing the origin of a data value, the definition of a data value, and operations to which the data value was subjected. The latter is further categorized into information about changes to a data value, movement of a data value, retrieval of a data value, and data quality checks, constraints or assessments to which the data value was subjected. The implications of tracking and managing data value-level metadata are explored.

Using EHR audit trail logs to analyze clinical workflow: A case study from community-based ambulatory clinics.

PubMed

Wu, Danny T Y; Smart, Nikolas; Ciemins, Elizabeth L; Lanham, Holly J; Lindberg, Curt; Zheng, Kai

2017-01-01

To develop a workflow-supported clinical documentation system, it is a critical first step to understand clinical workflow. While Time and Motion studies has been regarded as the gold standard of workflow analysis, this method can be resource consuming and its data may be biased due to the cognitive limitation of human observers. In this study, we aimed to evaluate the feasibility and validity of using EHR audit trail logs to analyze clinical workflow. Specifically, we compared three known workflow changes from our previous study with the corresponding EHR audit trail logs of the study participants. The results showed that EHR audit trail logs can be a valid source for clinical workflow analysis, and can provide an objective view of clinicians' behaviors, multi-dimensional comparisons, and a highly extensible analysis framework.

The effects of clinical supervision on supervisees and patients in cognitive behavioral therapy: a systematic review.

PubMed

Alfonsson, Sven; Parling, Thomas; Spännargård, Åsa; Andersson, Gerhard; Lundgren, Tobias

2018-05-01

Clinical supervision is a central part of psychotherapist training but the empirical support for specific supervision theories or features is unclear. The aims of this study were to systematically review the empirical research literature regarding the effects of clinical supervision on therapists' competences and clinical outcomes within Cognitive Behavior Therapy (CBT). A comprehensive database search resulted in 4103 identified publications. Of these, 133 were scrutinized and in the end 5 studies were included in the review for data synthesis. The five studies were heterogeneous in scope and quality and only one provided firm empirical support for the positive effects of clinical supervision on therapists' competence. The remaining four studies suffered from methodological weaknesses, but provided some preliminary support that clinical supervision may be beneficiary for novice therapists. No study could show benefits from supervision for patients. The research literature suggests that clinical supervision may have some potential effects on novice therapists' competence compared to no supervision but the effects on clinical outcomes are still unclear. While bug-in-the-eye live supervision may be more effective than standard delayed supervision, the effects of specific supervision models or features are also unclear. There is a continued need for high-quality empirical studies on the effects of clinical supervision in psychotherapy.

The Measurement of Causes of Patient Satisfaction and Dissatisfaction within Clinics at an Army Medical Treatment Facility

DTIC Science & Technology

1984-05-01

Satisfaction Measures Between Clinics.... 39 Lessons Learned From the Pilot Studies ...................... 42 Telephonic Versus Clinic Survey...Between Clinics. 63 Comments from Survey Participants ....................... 64 Lessons Learned from the Study ............................. 67...attempted to apply principles learned from a review of the multitude of studies conducted in the area of patient satisfaction. Validated dimensions of

Defining Research: The Effect of Linguistic Choices on the Intentions to Participate in Clinical Research.

PubMed

Strekalova, Yulia A

2017-06-01

Significant barriers to participant recruitment for clinical research (CR) are related to effective communication, and nurse coordinators are entrusted with being knowledge brokers between investigators and prospective participants. This prospective cohort study sought to identify linguistic choices that could inform and facilitate recruitment efforts. Healthy adults ( N = 204) were invited to join an online survey to assess the likelihood of participation in CR based on short and extended definitions of CR. Five short definitions included clinical trial, clinical study, health-related research study, community participatory study, and quality improvement study. The likelihood of participation in CR was the lowest for clinical trial and the highest for health-related research study. However, when only an extended definition was provided, those differences were not observed. A linguistic change from trial to study could lead to positive attitude toward CR and improvements in recruitment. However, ethical implications of linguistic choices should be considered.

Melaleuca alternifolia and its application against dental plaque and periodontal diseases: A systematic review.

PubMed

Casarin, Maísa; Pazinatto, Josiele; Santos, Roberto Christ Vianna; Zanatta, Fabricio Batistin

2018-02-01

This is a systematic review of clinical and laboratory studies evaluating the effect of Melaleuca alternifolia on periodontopathogens, dental plaque, gingivitis, periodontitis, and inflammatory responses. The PubMed, Cochrane, Web of science, Bireme, Lilacs, Prospero, Open Grey, and Clinical Trials databases were searched to identify potentially eligible studies through October 2016. Of 1,654 potentially eligible studies, 25 were included in the systematic review. Their methodology was evaluated through the Cochrane Handbook for clinical studies and the GRADE system for in vivo/in vitro studies. Although clinical studies must be interpreted with caution due to methodological limitations, laboratory studies have found promising results. In vitro evidences showed that M. alternifolia has bactericidal and bacteriostatic effects against the most prevalent periodontopathogens. Clinical studies found comparable effects to chlorhexidine 0.12% in reducing gingival inflammation, although the antiplaque effect was lower. M. alternifolia also showed antioxidant properties, which are beneficial to the host, allied to the reduction on immune-inflammatory responses to pathogens. This systematic review suggests that the M. alternifolia has potential anti-inflammatory and antimicrobial properties, which can be easily applied to the periodontal tissues. However, further clinical trials are needed to elucidate the clinical relevance of its application. Copyright © 2017 John Wiley & Sons, Ltd.

75 FR 47602 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and... vaccine annually) and an explanation of how the proposed study will either help support product approval...

Exploitation of prisoners in clinical research: perceptions of study participants

PubMed Central

Christopher, Paul P.; Stein, Michael D.; Johnson, Jennifer E.; Rich, Josiah D.; Friedmann, Peter D.; Clarke, Jennifer G.; Lidz, Charles W.

2015-01-01

This paper discusses findings of a study examining whether prisoners view their participation in clinical research studies as exploitative. Perspectives of seventy prisoners who were enrolled in one of six different clinical studies were analyzed. A minority of participants agreed with statements suggestive of potential exploitation. All but one participant believed that prisoners should have greater access to research. On balance, these data provide reassurance that prisoners in this sample do not view their involvement in clinical research as inappropriately exploitative. PMID:26964404

ACCP: economic evaluations of clinical pharmacy services: 2001-2005.

PubMed

Perez, Alexandra; Doloresco, Fred; Hoffman, James M; Meek, Patrick D; Touchette, Daniel R; Vermeulen, Lee C; Schumock, Glen T

2009-01-01

The objectives of this review were to summarize and evaluate studies that measured the economic impact of clinical pharmacy services published between 2001 and 2005 (inclusive) and to provide guidance on methodologic considerations to individuals performing such research in the future. A systematic literature search using the MEDLINE and International Pharmaceutical Abstracts databases was conducted to identify published economic evaluations of clinical pharmacy services. Studies were screened and then randomly assigned to reviewers, who reassessed inclusion and exclusion criteria and abstracted prespecified data from each study. Among the many characteristics examined in each study were study design and type of economic evaluation, setting and type of clinical pharmacy service, study quality, and results. Ninety-three articles were included in the final analysis. These studies were published in 43 different journals, most of which (68 [73.1%]) were pharmacy-based. Most studies were performed in hospitals (40 [43.0%]), ambulatory care clinics or physician's offices (20 [21.5%]), or community pharmacies (16 [17.2%]). The most common types of clinical pharmacy services evaluated were general pharmacotherapeutic monitoring services (32 [34.4%]), target drug programs (27 [29%]), and disease state-management services (21 [22.6%]). Full economic evaluations were performed in just less than half (45 [48.4%]) of the studies, and a positive economic benefit associated with clinical pharmacy services was noted in 31 (69%) of the 45 studies. Among 15 studies reporting data necessary to determine a benefit:cost ratio, the pooled median value was 4.81:1-meaning that for every $1 invested in clinical pharmacy services, $4.81 was achieved in reduced costs or other economic benefits. The quality of studies varied widely, with less than one half considered to be good to fair (40 [43.0%]); however, the proportion of studies using appropriate study designs increased compared with previous reviews. Based on the evidence examined in this review, clinical pharmacy services continue to provide a significant return on investment, but improvements are still needed in the methods used to evaluate the economic impact of these services.

Common pitfalls in statistical analysis: Clinical versus statistical significance

PubMed Central

Ranganathan, Priya; Pramesh, C. S.; Buyse, Marc

2015-01-01

In clinical research, study results, which are statistically significant are often interpreted as being clinically important. While statistical significance indicates the reliability of the study results, clinical significance reflects its impact on clinical practice. The third article in this series exploring pitfalls in statistical analysis clarifies the importance of differentiating between statistical significance and clinical significance. PMID:26229754

Dissemination of research into clinical nursing literature.

PubMed

Oermann, Marilyn H; Shaw-Kokot, Julia; Knafl, George J; Dowell, Jo

2010-12-01

The purpose of our study was to describe the dissemination of research into the clinical nursing literature. The literature provides a means of transferring knowledge from a research study through citations of the work by other authors. This was a citation analysis study to explore the dissemination of research into the clinical nursing literature, beginning with the publication of an original research study and including all of the citations to that article through 2009. The authors searched five academic nursing research journal titles, using CINAHL, for original research reports that had clinical relevance and were published between 1990-1999. The search process yielded a final data set of 28 research articles. For each of the articles, the authors searched three databases, CINAHL, Web of Science(®) and Google Scholar, to determine the citation patterns from the date of publication to August 2009. All of the research studies were cited in articles published in clinical journals although there was a wide range in the number of citations, from 3-80. The 28 research articles had a total of 759 citations; 717 (94.5%) of those citations were in articles published in clinical nursing journals. The median length of time between publication of the original study and the first citation was 1.5 years. Some of the studies were still being cited for 18 years after publication of the original work. All of the original research reports examined in this study were cited in articles in clinical journals, disseminating the research beyond the original work to reach clinicians. Clinical nursing journals keep readers up-to-date and informed about new practices in nursing and serve another important role: they disseminate research that is clinically relevant by publishing original studies and papers that cite research reports. © 2010 Blackwell Publishing Ltd.

Motives for participating in a clinical research trial: a pilot study in Brazil.

PubMed

Nappo, Solange A; Iafrate, Giovanna B; Sanchez, Zila M

2013-01-10

In the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3. to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil. Mixed-methods research was used (a qualitative-quantitative approach). A sample of 80 volunteers underwent a semi-structured interview, which was based on a survey script that was elaborated from discussions with key informants. The sample was randomly selected from a database of clinical study volunteers that was provided by Brazilian clinical study centers. The interviews were recorded and transcribed. Descriptive statistics were used for content analysis, including contingency tables with hypothesis testing. The motivations for clinical study participation were linked to types of benefit. The most frequently encountered motivations were financial gain and therapeutic alternative. Altruism was not a common motivator, and when altruism was present, it was observed as a secondary motivator. All participants reported that they understood the Informed Consent Statement (ICS). However, only two parts of the form were remembered by all of the volunteers: the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study. The present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies. Whether these study participants had an integral understanding of the ICS is not clear.

Facilitating Case Studies in Massage Therapy Clinical Education

PubMed Central

Baskwill, Amanda

2013-01-01

The integration of evidence into reflective health care practice has been on the rise in recent years and is a phenomenon that has affected all health care professions, including massage therapy. Clinical case studies are a research design that follows one patient or subject, making the studies ideal for use in clinical practice. They are valuable for communicating information from clinical practice to the broader community. Case studies have face validity that may be more valuable to individual practitioners than homogeneous randomized controlled trials, as the practitioner may recognize a complex patient in the case report. At Humber College, Student Massage Therapists (SMTs) create, conduct, and communicate results of a clinical case study prior to graduation. This article describes the process and experience. PMID:23730397

Regulatory approval of new medical devices: cross sectional study.

PubMed

Marcus, Hani J; Payne, Christopher J; Hughes-Hallett, Archie; Marcus, Adam P; Yang, Guang-Zhong; Darzi, Ara; Nandi, Dipankar

2016-05-20

 To investigate the regulatory approval of new medical devices.  Cross sectional study of new medical devices reported in the biomedical literature.  PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval.  Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article."  Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device.  5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be "substantially equivalent" to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published.  We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Beyond Clinical Case Studies in Psychoanalysis: A Review of Psychoanalytic Empirical Single Case Studies Published in ISI-Ranked Journals.

PubMed

Meganck, Reitske; Inslegers, Ruth; Krivzov, Juri; Notaerts, Liza

2017-01-01

Single case studies are at the origin of both theory development and research in the field of psychoanalysis and psychotherapy. While clinical case studies are the hallmark of psychoanalytic theory and practice, their scientific value has been strongly criticized. To address problems with the subjective bias of retrospective therapist reports and uncontrollability of clinical case studies, systematic approaches to investigate psychotherapy process and outcome at the level of the single case have been developed. Such empirical case studies are also able to bridge the famous gap between academic research and clinical practice as they provide clinically relevant insights into how psychotherapy works. This study presents a review of psychoanalytic empirical case studies published in ISI-ranked journals and maps the characteristics of the study, therapist, patient en therapies that are investigated. Empirical case studies increased in quantity and quality (amount of information and systematization) over time. While future studies could pay more attention to providing contextual information on therapist characteristics and informed consent considerations, the available literature provides a basis to conduct meta-studies of single cases and as such contribute to knowledge aggregation.

Beyond Clinical Case Studies in Psychoanalysis: A Review of Psychoanalytic Empirical Single Case Studies Published in ISI-Ranked Journals

PubMed Central

Meganck, Reitske; Inslegers, Ruth; Krivzov, Juri; Notaerts, Liza

2017-01-01

Single case studies are at the origin of both theory development and research in the field of psychoanalysis and psychotherapy. While clinical case studies are the hallmark of psychoanalytic theory and practice, their scientific value has been strongly criticized. To address problems with the subjective bias of retrospective therapist reports and uncontrollability of clinical case studies, systematic approaches to investigate psychotherapy process and outcome at the level of the single case have been developed. Such empirical case studies are also able to bridge the famous gap between academic research and clinical practice as they provide clinically relevant insights into how psychotherapy works. This study presents a review of psychoanalytic empirical case studies published in ISI-ranked journals and maps the characteristics of the study, therapist, patient en therapies that are investigated. Empirical case studies increased in quantity and quality (amount of information and systematization) over time. While future studies could pay more attention to providing contextual information on therapist characteristics and informed consent considerations, the available literature provides a basis to conduct meta-studies of single cases and as such contribute to knowledge aggregation. PMID:29046660

Extended cooperation in clinical studies through exchange of CDISC metadata between different study software solutions.

PubMed

Kuchinke, W; Wiegelmann, S; Verplancke, P; Ohmann, C

2006-01-01

Our objectives were to analyze the possibility of an exchange of an entire clinical study between two different and independent study software solutions. The question addressed was whether a software-independent transfer of study metadata can be performed without programming efforts and with software routinely used for clinical research. Study metadata was transferred with ODM standard (CDISC). Study software systems employed were MACRO (InferMed) and XTrial (XClinical). For the Proof of Concept, a test study was created with MACRO and exported as ODM. For modification and validation of the ODM export file XML-Spy (Altova) and ODM-Checker (XML4Pharma) were used. Through exchange of a complete clinical study between two different study software solutions, a Proof of Concept of the technical feasibility of a system-independent metadata exchange was conducted successfully. The interchange of study metadata between two different systems at different centers was performed with minimal expenditure. A small number of mistakes had to be corrected in order to generate a syntactically correct ODM file and a "vendor extension" had to be inserted. After these modifications, XTrial exhibited the study, including all data fields, correctly. However, the optical appearance of both CRFs (case report forms) was different. ODM can be used as an exchange format for clinical studies between different study software. Thus, new forms of cooperation through exchange of metadata seem possible, for example the joint creation of electronic study protocols or CRFs at different research centers. Although the ODM standard represents a clinical study completely, it contains no information about the representation of data fields in CRFs.

75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... running to unintended areas, etc. Wound dehiscence Bench Testing, Shelf Life Testing, Animal Testing, Clinical Studies, Labeling. Adverse tissue reaction and chemical Biocompatibility Animal burns. Testing, Clinical Studies. Infection Bench Testing, Biocompatibility Animal Testing, Clinical Studies, Sterility...

Asking good clinical research questions and choosing the right study design.

PubMed

Bragge, P

2010-07-01

Clinicians and researchers seek answers to clinical research questions, primarily by accessing the results of clinical research studies. This paper moves the focus of research enquiry from getting answers to developing good clinical research questions. Using worked examples, the steps involved in refining questions drawn from various sources to create 'answerable' clinical research questions using the 'PICO' principle are described. Issues to consider in prioritising clinical research questions are also identified. Theoretical and practical considerations involved in choosing the right study design for a clinical research question are then discussed using the worked examples. These include: Copyright (c) 2010 Elsevier Ltd. All rights reserved.

An exploration into study design for biomarker identification: issues and recommendations.

PubMed

Hall, Jacqueline A; Brown, Robert; Paul, Jim

2007-01-01

Genomic profiling produces large amounts of data and a challenge remains in identifying relevant biological processes associated with clinical outcome. Many candidate biomarkers have been identified but few have been successfully validated and make an impact clinically. This review focuses on some of the study design issues encountered in data mining for biomarker identification with illustrations of how study design may influence the final results. This includes issues of clinical endpoint use and selection, power, statistical, biological and clinical significance. We give particular attention to study design for the application of supervised clustering methods for identification of gene networks associated with clinical outcome and provide recommendations for future work to increase the success of identification of clinically relevant biomarkers.

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

PubMed

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

Economic evaluations of clinical pharmacist interventions on hospital inpatients: a systematic review of recent literature.

PubMed

Gallagher, James; McCarthy, Suzanne; Byrne, Stephen

2014-12-01

Clinical and cost-effectiveness evidence are needed to justify the existence or extension of routine clinical pharmacy services in hospital settings. Previous reviews have indicated that clinical pharmacist interventions are likely to have a positive economic impact on hospital budgets but highlighted issues relating to the quality of studies. The primary aim of this review was to feature economic evaluations of clinical pharmacy services which targeted hospital inpatients. The review focused on the current cost-effectiveness status of different services, in addition to evaluating the quality of individual studies. Results of this systematic review were compared with cost-effectiveness and quality related findings of reviews which considered earlier time frames and alternative settings. A systematic review of the literature included a review of the following databases: Academic Search Complete, Cochrane Library, EconLit, Embase Elsevier, NHS Economic Evaluation Database and PubMed. Only studies with an economic assessment of a clinical pharmacy service provided in a hospital setting were included. Data relating to the cost-effectiveness was extracted from eligible studies. Methodologies employed and overall quality of the studies was also reviewed. A grading system was applied to determine the quality of studies. Consolidated Health Economic Evaluation Reporting Standards statement was employed to determine which aspects of a high quality health economic study were employed. Twenty studies were deemed eligible for inclusion. Overall, pharmacist interventions had a positive impact on hospital budgets. Only three studies (15 %) were deemed to be "good-quality" studies. No 'novel'clinical pharmacist intervention was identified during the course of this review. Clinical pharmacy interventions continue to provide cost savings. However, the standard of studies published has stagnated or even deteriorated in comparison with those included in previous reviews. Utilisation of published guidelines at initial stages of future studies may help improve the overall quality of studies.

Feasibility of Conducting Autism Biomarker Research in the Clinical Setting.

PubMed

Sices, Laura; Pawlowski, Katherine; Farfel, Laura; Phillips, Deirdre; Howe, Yamini; Cochran, David M; Choueiri, Roula; Forbes, Peter W; Brewster, Stephanie J; Frazier, Jean A; Neumeyer, Ann; Bridgemohan, Carolyn

2017-09-01

Recruitment and completion of research activities during regular clinical care has the potential to increase research participation in complex neurodevelopmental disorders. We evaluated the feasibility, and effect on clinical care, of conducting biomarker research within a subspecialty clinical visit for autism spectrum disorder (ASD). Children, aged 5 to 10 years, were recruited by providers in ASD clinics at 5 institutions. Biomarkers collected were growth measurements, head circumference, neurologic and dysmorphology examinations, digit ratio (2D:4D) measurement, and platelet serotonin and urinary melatonin sulfate excretion levels. Parents completed the Aberrant Behavior Checklist-Community and a medical/demographic questionnaire. Cognitive level was abstracted from the medical record. Parents and clinicians completed surveys on the effect of the study on the clinical visit. Eighty-three children and their caregivers participated. Factors limiting participation included difficulty reaching families by phone and parent concern about the study blood draw requirement. All children completed at least 4 of 7 planned research activities. Demographic factors, educational placement, and child behavior were not associated with completion of study activities. Lower nonverbal cognitive function was weakly associated with fewer activities completed. Forty-four percent of clinicians reported an effect of the research study on the clinical visit. However, neither parent-reported nor clinician-reported effect was associated with the degree of study activity completion. Recruiting study participants in the context of scheduled ASD clinical visits required significant effort. However, once recruited, participants completed most study activities, regardless of behavioral symptom severity. Research activities did not adversely affect the clinical visit.

Systematic reviews: I. The correlation between laboratory tests on marginal quality and bond strength. II. The correlation between marginal quality and clinical outcome.

PubMed

Heintze, Siegward D

2007-01-01

An accepted principle in restorative dentistry states that restorations should be placed with the best marginal quality possible to avoid postoperative sensitivity, marginal discoloration, and secondary caries. Different laboratory methods claim to predict the clinical performance of restorative materials, for example, tests of bond strength and microleakage and gap analysis. The purpose of this review was twofold: (1) find studies that correlated the results of bond strength tests with either microleakage or gap analysis for the same materials, and (2) find studies that correlated the results of microleakage and/or gaps with the clinical parameters for the same materials. Furthermore, influencing factors on the results of the laboratory tests were reviewed and assessed. For the first question, searches for studies were conducted in the MEDLINE database and IADR/AADR abtracts online with specific search and inclusion criteria. The outcome for each study was assessed on the basis of the statistical test applied in the study, and finally the number of studies with or without correlation was compiled. For the second question, results of the quantitative marginal analysis of Class V restorations published by the University of Zürich with the same test protocol and prospective clinical trials were searched that investigated the same materials for at least 2 years in Class V cavities. Pearson correlation coefficients were calculated for pooled data of materials and clinical outcome parameters such as retention loss, marginal discoloration, marginal integrity, and secondary caries. For the correlation of dye penetration and clinical outcome, studies on Class V restorations published by the same research institute were searched in MEDLINE that examined the same adhesive systems as the selected clinical trials. For the correlation bond strength/microleakage, 30 studies were included into the review, and for the correlation bond strength/gap analysis 18 studies. For both topics, about 80% of the studies revealed that there was no correlation between the two methods. For the correlation quantitative marginal analysis/clinical outcome, data were compared to the clinical outcome of 11 selected clinical studies. In only 2 out of the 11 studies (18%) did the clinical outcome match the prognosis based on the laboratory tests; the remaining studies did not show any correlation. When pooling data on 20 adhesive systems, no correlation was found between the percentage of continuous margin of restorations placed in extracted premolars and the percentage of teeth that showed no retention loss in clinical studies, no discoloured margins, acceptable margins, or absence of secondary caries. With regard to the correlation of dye penetration and clinical studies, no sufficient number of studies was found that matched the inclusion criteria. However, literature data suggest that there is no correlation between microleakage data as measured in the laboratory and clinical parameters. The results of bond strength tests did not correlate with laboratory tests that evaluated the marginal seal of restorations such as microleakage or gap analysis. The quantitative marginal analysis of Class V fillings in the laboratory was unable to predict the performance of the same materials in vivo. Therefore, microleakage tests or the quantitative marginal analysis should be abandoned and research should focus on laboratory tests that are validated with regard to their ability to satisfactorily predict the clinical performance of restorative materials.

Vitamins in Pancreatic Cancer: A Review of Underlying Mechanisms and Future Applications12

PubMed Central

Davis-Yadley, Ashley H; Malafa, Mokenge P

2015-01-01

Although there is increasing evidence that vitamins influence pancreatic adenocarcinoma biology and carcinogenesis, a comprehensive review is lacking. In this study, we performed a PubMed literature search to review the anticancer mechanisms and the preclinical and clinical studies that support the development of the bioactive vitamins A, C, D, E, and K in pancreatic cancer intervention. Preclinical studies have shown promising results for vitamin A in pancreatic cancer prevention, with clinical trials showing intriguing responses in combination with immunotherapy. For vitamin C, preclinical studies have shown slower tumor growth rates and/or increased survival when used alone or in combination with gemcitabine, with clinical trials with this combination revealing decreased primary tumor sizes and improved performance status. Preclinical studies with vitamin D analogues have shown potent antiproliferative effects and repression of migration and invasion of pancreatic cancer cells, with a clinical trial showing increased time to progression when calciferol was added to docetaxel. For vitamin E, preclinical studies have shown that δ-tocotrienol and γ-tocotrienol inhibited tumor cell growth and survival and augmented gemcitabine activity. Early-phase clinical trials with δ-tocotrienol are ongoing. Vitamin K demonstrates activation of apoptosis and inhibition of cellular growth in pancreatic tumor cells; however, there are no clinical studies available for further evaluation. Although preclinical and clinical studies are encouraging, randomized controlled trials with endpoints based on insights gained from mechanistic and preclinical studies and early-phase clinical trials are required to determine the efficacy of bioactive vitamin interventions in pancreatic cancer. PMID:26567201

Vitamins in pancreatic cancer: a review of underlying mechanisms and future applications.

PubMed

Davis-Yadley, Ashley H; Malafa, Mokenge P

2015-11-01

Although there is increasing evidence that vitamins influence pancreatic adenocarcinoma biology and carcinogenesis, a comprehensive review is lacking. In this study, we performed a PubMed literature search to review the anticancer mechanisms and the preclinical and clinical studies that support the development of the bioactive vitamins A, C, D, E, and K in pancreatic cancer intervention. Preclinical studies have shown promising results for vitamin A in pancreatic cancer prevention, with clinical trials showing intriguing responses in combination with immunotherapy. For vitamin C, preclinical studies have shown slower tumor growth rates and/or increased survival when used alone or in combination with gemcitabine, with clinical trials with this combination revealing decreased primary tumor sizes and improved performance status. Preclinical studies with vitamin D analogues have shown potent antiproliferative effects and repression of migration and invasion of pancreatic cancer cells, with a clinical trial showing increased time to progression when calciferol was added to docetaxel. For vitamin E, preclinical studies have shown that δ-tocotrienol and γ-tocotrienol inhibited tumor cell growth and survival and augmented gemcitabine activity. Early-phase clinical trials with δ-tocotrienol are ongoing. Vitamin K demonstrates activation of apoptosis and inhibition of cellular growth in pancreatic tumor cells; however, there are no clinical studies available for further evaluation. Although preclinical and clinical studies are encouraging, randomized controlled trials with endpoints based on insights gained from mechanistic and preclinical studies and early-phase clinical trials are required to determine the efficacy of bioactive vitamin interventions in pancreatic cancer. © 2015 American Society for Nutrition.

The STARD statement for reporting diagnostic accuracy studies: application to the history and physical examination.

PubMed

Simel, David L; Rennie, Drummond; Bossuyt, Patrick M M

2008-06-01

The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test. Nonsystematic review of the STARD statement. Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus. The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians. The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient's history and physical examination.

Platelet-rich plasma in orthopedic therapy: a comparative systematic review of clinical and experimental data in equine and human musculoskeletal lesions.

PubMed

Brossi, Patrícia M; Moreira, Juliana J; Machado, Thaís S L; Baccarin, Raquel Y A

2015-04-22

This systematic review aimed to present and critically appraise the available information on the efficacy of platelet rich plasma (PRP) in equine and human orthopedic therapeutics and to verify the influence of study design and methodology on the assumption of PRP's efficacy. We searched Medline, PubMed, Embase, Bireme and Google Scholar without restrictions until July 2013. Randomized trials, human cohort clinical studies or case series with a control group on the use of PRP in tendons, ligaments or articular lesions were included. Equine clinical studies on the same topics were included independently of their design. Experimental studies relevant to the clarification of PRP's effects and mechanisms of action in tissues of interest, conducted in any animal species, were selected. This review included 123 studies. PRP's beneficial effects were observed in 46.7% of the clinical studies, while the absence of positive effects was observed in 43.3%. Among experimental studies, 73% yielded positive results, and 7.9% yielded negative results. The most frequent flaws in the clinical trials' designs were the lack of a true placebo group, poor product characterization, insufficient blinding, small sampling, short follow-up periods, and adoption of poor outcome measures. The methods employed for PRP preparation and administration and the selected outcome measures varied greatly. Poor study design was a common feature of equine clinical trials. From studies in which PRP had beneficial effects, 67.8% had an overall high risk of bias. From the studies in which PRP failed to exhibit beneficial effects, 67.8% had an overall low risk of bias. Most experimental studies revealed positive effects of PRP. Although the majority of equine clinical studies yielded positive results, the human clinical trials' results failed to corroborate these findings. In both species, beneficial results were more frequently observed in studies with a high risk of bias. The use of PRP in musculoskeletal lesions, although safe and promising, has still not shown strong evidence in clinical scenarios.

Characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov.

PubMed

Stockmann, Chris; Sherwin, Catherine M T; Koren, Gideon; Campbell, Sarah C; Constance, Jonathan E; Linakis, Matthew; Balch, Alfred; Varner, Michael W; Spigarelli, Michael G

2014-04-01

Physiologic changes during pregnancy alter the pharmacokinetics, safety, and efficacy of many drugs. For clinicians, there is often uncertainty regarding the safety of these drugs due to a scarcity of published data. This study aimed to comprehensively evaluate the characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov from 2007 to 2012. Primary outcome measures, funding sources, inclusion criteria, and the reporting of study results were evaluated. A manual review of Medline/PubMed was performed to identify publications associated with studies registered in ClinicalTrials.gov. Of 93,709 total studies, there were 5,203 (6%) obstetric studies registered in ClinicalTrials.gov. Interventional studies accounted for 70% and 30% were observational. Clinical trials of drugs (49%), procedures (13%), and behavioral interventions (12%) were most common. Among interventional drug trials, 84% featured randomized allocation to study arms and 93% included measures of safety and/or efficacy as primary endpoints. Of 946 (18%) studies completed more than 2 years ago, only 11% had reported results and <7% had been published. In an area with a great need for evidence of safe and effective therapies, the low publication rate of completed studies incorporating elements of high-quality trial design is concerning. The sources of this trend should be closely investigated. © 2013, The American College of Clinical Pharmacology.

Tendinopathies and platelet-rich plasma (PRP): from pre-clinical experiments to therapeutic use

PubMed Central

Kaux, Jean-François; Drion, Pierre; Croisier, Jean-Louis; Crielaard, Jean-Michel

2015-01-01

Objectives: The restorative properties of platelets, through the local release of growth factors, are used in various medical areas. This article reviews fundamental and clinical research relating to platelet-rich plasma applied to tendinous lesions. Materials and method: Articles in French and English, published between 1 January 2012 and 31 December 2014. dealing with PRP and tendons were searched for using the Medline and Scopus data bases. Results: Forty-seven articles were identified which addressed pre-clinical and clinical studies: 27 relating to in vitro and in vivo animal studies and 20 relating to human studies. Of these, five addressed lateral epicondylitis, two addressed rotator cuff tendinopathies, ten dealt with patellar tendinopathies and three looked at Achilles tendinopathies. Conclusions: The majority of pre-clinical studies show that PRP stimulates the tendon’s healing process. However, clinical series remain more controversial and level 1, controlled, randomised studies are still needed. PMID:26195890

Barriers to Practical Learning in the Field: A Qualitative Study of Iranian Nursing Students' Experiences.

PubMed

Jahanpour, Faezeh; Azodi, Parviz; Azodi, Farzan; Khansir, Ali Akbar

2016-06-01

Clinical training is an integral part of nursing education; however, some studies have shown that it is not always efficient. This study aimed to find out the factors that can impede nursing students' clinical learning. In this qualitative study, data were collected via reflective journal writing. Purposeful sampling was used, and 12 senior nursing students were recruited to the study. The data were analyzed using a content analysis method. Three main categories were derived, including inappropriate communication, ineffective role models, and theory-practice gaps. Students perceived that inappropriate communication between instructors, staff members, and students had the greatest impact on student learning. The competence of clinical instructors and staff is an important factor affecting students' training. The clinical learning environment does not always integrate theory and practice together. Nursing students did not experience effective clinical learning. Having expert instructors and supportive communication are important factors in creating a clinical learning environment.

An overview of clinical studies on fiber post systems.

PubMed

Dikbas, Idil; Tanalp, Jale

2013-01-01

Intraradicular posts are useful adjuncts in the restoration of endodontically treated teeth. These systems have undergone a significant evolution in recent years, and fiber-reinforced systems have started to be incorporated into routine clinical care more frequently. Despite the high number of laboratory studies pertaining to the characteristics of fiber posts, clinical studies evaluating their general success rates are rather limited. Since clinical investigations are reliable means to achieve information about the general behavior pattern of materials or techniques, assessment of this data will be beneficial to have a better understanding of fiber-reinforced intraradicular post systems. The purpose of this paper was to make a summary of clinical studies regarding various fiber posts. A PubMed search was conducted and articles dating back to 1990 were retrieved. The paper provides an overview of clinical studies on fiber posts specifically in the last decade as well as commentary analysis.

An Overview of Clinical Studies on Fiber Post Systems

PubMed Central

Dikbas, Idil; Tanalp, Jale

2013-01-01

Intraradicular posts are useful adjuncts in the restoration of endodontically treated teeth. These systems have undergone a significant evolution in recent years, and fiber-reinforced systems have started to be incorporated into routine clinical care more frequently. Despite the high number of laboratory studies pertaining to the characteristics of fiber posts, clinical studies evaluating their general success rates are rather limited. Since clinical investigations are reliable means to achieve information about the general behavior pattern of materials or techniques, assessment of this data will be beneficial to have a better understanding of fiber-reinforced intraradicular post systems. The purpose of this paper was to make a summary of clinical studies regarding various fiber posts. A PubMed search was conducted and articles dating back to 1990 were retrieved. The paper provides an overview of clinical studies on fiber posts specifically in the last decade as well as commentary analysis. PMID:24250255

Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.

PubMed

Walden, Anita; Nahm, Meredith; Barnett, M Edwina; Conde, Jose G; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E; Eisenstein, Eric L

2011-01-01

New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.

Economic Analysis of Centralized vs. Decentralized Electronic Data Capture in Multi-Center Clinical Studies

PubMed Central

Walden, Anita; Nahm, Meredith; Barnett, M. Edwina; Conde, Jose G.; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E.; Eisenstein, Eric L.

2012-01-01

Background New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. Methods We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. Main Outcome Measures The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Results Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Conclusion Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs. PMID:21335692

Standardized patient walkthroughs in the National Drug Abuse Treatment Clinical Trials Network: common challenges to protocol implementation.

PubMed

Fussell, Holly E; Kunkel, Lynn E; McCarty, Dennis; Lewy, Colleen S

2011-09-01

Training research staff to implement clinical trials occurring in community-based addiction treatment programs presents unique challenges. Standardized patient walkthroughs of study procedures may enhance training and protocol implementation. Examine and discuss cross-site and cross-study challenges of participant screening and data collection procedures identified during standardized patient walkthroughs of multi-site clinical trials. Actors portrayed clients and "walked through" study procedures with protocol research staff. The study completed 57 walkthroughs during implementation of 4 clinical trials. Observers and walkthrough participants identified three areas of concern (consent procedures, screening and assessment processes, and protocol implementation) and made suggestions for resolving the concerns. Standardized patient walkthroughs capture issues with study procedures previously unidentified with didactic training or unscripted rehearsals. Clinical trials within the National Drug Abuse Treatment Clinical Trials Network are conducted in addiction treatment centers that vary on multiple dimensions. Based on walkthrough observations, the national protocol team and local site leadership modify standardized operating procedures and resolve cross-site problems prior to recruiting study participants. The standardized patient walkthrough improves consistency across study sites and reduces potential site variation in study outcomes.

The Database for Aggregate Analysis of ClinicalTrials.gov (AACT) and Subsequent Regrouping by Clinical Specialty

PubMed Central

Tasneem, Asba; Aberle, Laura; Ananth, Hari; Chakraborty, Swati; Chiswell, Karen; McCourt, Brian J.; Pietrobon, Ricardo

2012-01-01

Background The ClinicalTrials.gov registry provides information regarding characteristics of past, current, and planned clinical studies to patients, clinicians, and researchers; in addition, registry data are available for bulk download. However, issues related to data structure, nomenclature, and changes in data collection over time present challenges to the aggregate analysis and interpretation of these data in general and to the analysis of trials according to clinical specialty in particular. Improving usability of these data could enhance the utility of ClinicalTrials.gov as a research resource. Methods/Principal Results The purpose of our project was twofold. First, we sought to extend the usability of ClinicalTrials.gov for research purposes by developing a database for aggregate analysis of ClinicalTrials.gov (AACT) that contains data from the 96,346 clinical trials registered as of September 27, 2010. Second, we developed and validated a methodology for annotating studies by clinical specialty, using a custom taxonomy employing Medical Subject Heading (MeSH) terms applied by an NLM algorithm, as well as MeSH terms and other disease condition terms provided by study sponsors. Clinical specialists reviewed and annotated MeSH and non-MeSH disease condition terms, and an algorithm was created to classify studies into clinical specialties based on both MeSH and non-MeSH annotations. False positives and false negatives were evaluated by comparing algorithmic classification with manual classification for three specialties. Conclusions/Significance The resulting AACT database features study design attributes parsed into discrete fields, integrated metadata, and an integrated MeSH thesaurus, and is available for download as Oracle extracts (.dmp file and text format). This publicly-accessible dataset will facilitate analysis of studies and permit detailed characterization and analysis of the U.S. clinical trials enterprise as a whole. In addition, the methodology we present for creating specialty datasets may facilitate other efforts to analyze studies by specialty groups. PMID:22438982

The database for aggregate analysis of ClinicalTrials.gov (AACT) and subsequent regrouping by clinical specialty.

PubMed

Tasneem, Asba; Aberle, Laura; Ananth, Hari; Chakraborty, Swati; Chiswell, Karen; McCourt, Brian J; Pietrobon, Ricardo

2012-01-01

The ClinicalTrials.gov registry provides information regarding characteristics of past, current, and planned clinical studies to patients, clinicians, and researchers; in addition, registry data are available for bulk download. However, issues related to data structure, nomenclature, and changes in data collection over time present challenges to the aggregate analysis and interpretation of these data in general and to the analysis of trials according to clinical specialty in particular. Improving usability of these data could enhance the utility of ClinicalTrials.gov as a research resource. The purpose of our project was twofold. First, we sought to extend the usability of ClinicalTrials.gov for research purposes by developing a database for aggregate analysis of ClinicalTrials.gov (AACT) that contains data from the 96,346 clinical trials registered as of September 27, 2010. Second, we developed and validated a methodology for annotating studies by clinical specialty, using a custom taxonomy employing Medical Subject Heading (MeSH) terms applied by an NLM algorithm, as well as MeSH terms and other disease condition terms provided by study sponsors. Clinical specialists reviewed and annotated MeSH and non-MeSH disease condition terms, and an algorithm was created to classify studies into clinical specialties based on both MeSH and non-MeSH annotations. False positives and false negatives were evaluated by comparing algorithmic classification with manual classification for three specialties. The resulting AACT database features study design attributes parsed into discrete fields, integrated metadata, and an integrated MeSH thesaurus, and is available for download as Oracle extracts (.dmp file and text format). This publicly-accessible dataset will facilitate analysis of studies and permit detailed characterization and analysis of the U.S. clinical trials enterprise as a whole. In addition, the methodology we present for creating specialty datasets may facilitate other efforts to analyze studies by specialty groups.

Twenty-Year Systematic Review of the Hip Pathology, Risk Factors, Treatment, and Clinical Outcomes in Artistic Athletes-Dancers, Figure Skaters, and Gymnasts.

PubMed

Bolia, Ioanna; Utsunomiya, Hajime; Locks, Renato; Briggs, Karen; Philippon, Marc J

2018-01-01

To identify (1) the predominant level of evidence of the clinical studies regarding the hip pathology, risk factors, treatment, and clinical outcomes in artistic athletes (dancers, figure skaters, and gymnasts) (2) the most commonly reported hip pathology, risk factors, treatments, and clinical outcomes in dancers, figure skaters, and gymnasts. To conduct this systematic review PubMed, EMBASE, and Scopus databases were searched for relevant studies and pertinent data were collected from the eligible articles. Included were studies which reported hip injuries in artistic athletes, the risk factors, treatment, and/or the clinical outcomes. We excluded case reports or irrelevant studies. No meta-analysis was performed because of study heterogeneity. The methodical index for nonrandomized studies (MINORS) criteria were used for quality control. Thirty-eight studies were included in the analysis. The mean MINORS score was 13.6 ± 4.6 points indicating fair quality of evidence of the included articles. The predominant level of evidence was level IV. Chondrolabral pathology and muscle injuries were the most commonly reported pathologies. We found only 2 risk factor analysis studies; however, many studies reported risk correlation between artistic sports or imaging findings and hip pathology. Treatment strategies were reported in only 7 studies, clinical outcomes are significantly underreported. Chondrolabral pathology was the most commonly reported hip pathology in artistic athletes, however, prospective cohort studies are necessary to really understand these injuries and their associated risk factors. The lack of clinical outcomes is significant and future data collection is required to assess the effectiveness of the various treatments.

Tissue engineering of the bladder--reality or myth? A systematic review.

PubMed

Sloff, Marije; Simaioforidis, Vasileios; de Vries, Rob; Oosterwijk, Egbert; Feitz, Wout

2014-10-01

We systematically reviewed preclinical studies in the literature to evaluate the potential of tissue engineering of the bladder. Study outcomes were compared to the available clinical evidence to assess the feasibility of tissue engineering for future clinical use. Preclinical studies of tissue engineering for bladder augmentation were identified through a systematic search of PubMed and Embase™ from January 1, 1980 to January 1, 2014. Primary studies in English were included if bladder reconstruction after partial cystectomy was performed using a tissue engineered biomaterial in any animal species, with cystometric bladder capacity as an outcome measure. Outcomes were compared to clinical studies available at http://www.clinicaltrials.gov and published clinical studies. A total of 28 preclinical studies are included, demonstrating remarkable heterogeneity in study characteristics and design. Studies in which preoperative bladder volumes were compared to postoperative volumes were considered the most clinically relevant (18 studies). Bladder augmentation through tissue engineering resulted in a normal bladder volume in healthy animals, with the influence of a cellular component being negligible. Furthermore, experiments in large animal models (pigs and dogs) approximated the desired bladder volume more accurately than in smaller species. The initial clinical experience was based on seemingly predictive healthy animal models with a promising outcome. Unfortunately these results were not substantiated in all clinical trials, revealing dissimilar outcomes in different clinical/disease backgrounds. Thus, the translational predictability of a model using healthy animals might be questioned. Through this systematic approach we present an unbiased overview of all published preclinical studies investigating the effect of bladder tissue engineering on cystometric bladder capacity. Preclinical research in healthy animals appears to show the feasibility of bladder augmentation by tissue engineering. However, in view of the disappointing clinical results based on healthy animal models new approaches should also be evaluated in preclinical models using dysfunctional/diseased bladders. This endeavor may aid in the development of clinically applicable tissue engineered bladder augmentation with satisfactory long-term outcome. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Clinical studies of innovative medical devices: what level of evidence for hospital-based health technology assessment?

PubMed

Boudard, Aurélie; Martelli, Nicolas; Prognon, Patrice; Pineau, Judith

2013-08-01

Like health technology assessment (HTA) agencies, hospitals are faced with requests for innovative and costly medical devices. However, local decision makers are frequently confronted with a lack of high-quality clinical data when assessing the effectiveness of innovative medical devices. The aim of this study was to quantify the level of evidence available for innovative medical devices in the context of hospital-based HTA. We searched the Medline, Embase and Cochrane Library databases for articles, letters and reports relating to 32 innovative medical devices requested at our hospital between January 2008 and March 2012. All clinical studies retrieved were screened and classified according to the Sackett 5-point level-of-evidence scale. We screened and classified 217 studies: 215 clinical trials and 2 cost-effectiveness studies. Only 47 of the 215 clinical studies (22%) provided high-level clinical evidence (levels 1-2); 33 (15%) were randomized controlled trials (RCTs). More than half of the 215 studies (52.1%) included fewer than 30 patients. Only 14 of the 47 high-quality studies reported the amount of missing data. For implantable medical devices, 84 (71.8%) studies specified the follow-up period and the mean follow-up period was 18.9 months. Finally, methodological quality did not increase with the risk level of the medical device. Our findings confirm that only a few studies of innovative medical devices provide high-level clinical evidence. Nevertheless, RCT may be the 'gold standard' for drugs, but it is not always appropriate for medical devices. Changes to the European regulation of medical devices, with the requirement for a demonstration of clinical efficacy and safety before release onto the European market, have raised expectations. © 2013 John Wiley & Sons Ltd.

Mobile phone interference with medical equipment and its clinical relevance: a systematic review.

PubMed

Lawrentschuk, Nathan; Bolton, Damien M

2004-08-02

To conduct a systematic review of studies on clinically relevant digital mobile phone electromagnetic interference with medical equipment. MEDLINE and SUMSEARCH were searched for the period 1966-2004. The Cochrane Library and Database of Abstracts of Reviews of Effects were also searched for systematic reviews. Studies were eligible if published in a peer-reviewed journal in English, and if they included testing of digital mobile phones for clinically relevant interference with medical equipment used to monitor or treat patients, but not implantable medical devices. As there was considerable heterogeneity in medical equipment studied and the conduct of testing, results were summarised rather than subjected to meta-analysis. Clinically relevant electromagnetic interference (EMI) secondary to mobile phones potentially endangering patients occurred in 45 of 479 devices tested at 900 MHz and 14 of 457 devices tested at 1800 MHz. However, in the largest studies, the prevalence of clinically relevant EMI was low. Most clinically relevant EMI occurred when mobile phones were used within 1 m of medical equipment. Although testing was not standardised between studies and equipment tested was not identical, it is of concern that at least 4% of devices tested in any study were susceptible to clinically relevant EMI. All studies recommend some type of restriction of mobile phone use in hospitals, with use greater than 1 m from equipment and restrictions in clinical areas being the most common.

Characteristics of antimicrobial studies registered in the USA through ClinicalTrials.Gov

PubMed Central

Stockmann, Chris; Sherwin, Catherine M.T.; Ampofo, Krow; Hersh, Adam L.; Pavia, Andrew T.; Byington, Carrie L.; Ward, Robert M.; Spigarelli, Michael G.

2013-01-01

Increasing rates of antimicrobial-resistant infections and the dwindling pipeline of new agents necessitate judicious, evidence-based antimicrobial prescribing. Clinical trials represent a vital resource for establishing evidence of safety and efficacy, which are crucial to guiding antimicrobial treatment decisions. The objective of this study was to comprehensively evaluate the characteristics of antimicrobial research studies registered in ClinicalTrials.gov. Primary outcome measures, funding sources, inclusion criteria and the reporting of study results were evaluated for 16 055 antimicrobial studies registered in ClinicalTrials.gov as of mid 2012. Interventional studies accounted for 93% of registered antimicrobial studies. Clinical trials of drugs (82%) and biologics (9%) were most common. Antibacterial, antiviral and antifungal studies accounted for 43%, 41% and 16% of drug trials, respectively. Among interventional drug trials, 73% featured randomised allocation to study arms and 71% included measures of safety and/or efficacy as primary endpoints. Children were eligible for enrolment in 26% of studies. Among the studies, 60% were sponsored primarily by non-profit organisations, 30% by industry and 10% by the federal government. Only 7% of studies reported results; however, 71% of these were sponsored primarily by industry. Antimicrobial studies commonly incorporated elements of high-quality trial design, including randomisation and safety/efficacy endpoints. Publication of study results and updating of ClinicalTrials.gov should be encouraged for all studies, with particular attention paid to research sponsored by non-profit organisations and governmental agencies. Leveraging the application of these data to guide the careful selection of antimicrobial agents will be essential to preserve their utility for years to come. PMID:23726436

Clinical relevance vs. statistical significance: Using neck outcomes in patients with temporomandibular disorders as an example.

PubMed

Armijo-Olivo, Susan; Warren, Sharon; Fuentes, Jorge; Magee, David J

2011-12-01

Statistical significance has been used extensively to evaluate the results of research studies. Nevertheless, it offers only limited information to clinicians. The assessment of clinical relevance can facilitate the interpretation of the research results into clinical practice. The objective of this study was to explore different methods to evaluate the clinical relevance of the results using a cross-sectional study as an example comparing different neck outcomes between subjects with temporomandibular disorders and healthy controls. Subjects were compared for head and cervical posture, maximal cervical muscle strength, endurance of the cervical flexor and extensor muscles, and electromyographic activity of the cervical flexor muscles during the CranioCervical Flexion Test (CCFT). The evaluation of clinical relevance of the results was performed based on the effect size (ES), minimal important difference (MID), and clinical judgement. The results of this study show that it is possible to have statistical significance without having clinical relevance, to have both statistical significance and clinical relevance, to have clinical relevance without having statistical significance, or to have neither statistical significance nor clinical relevance. The evaluation of clinical relevance in clinical research is crucial to simplify the transfer of knowledge from research into practice. Clinical researchers should present the clinical relevance of their results. Copyright © 2011 Elsevier Ltd. All rights reserved.

Clinical studies of the Research Committee on Intractable Vasculitides, the Ministry of Health, Labour and Welfare of Japan.

PubMed

Makino, Hirofumi; Sada, Ken-Ei

2013-10-01

In Japan, the Research Committee on Intractable Vasculitides, supported by the Ministry of Health, Labour and Welfare, has been promoting basic and clinical research on vasculitis since 1972. The present Research Committee on Intractable Vasculitides comprises 4 subcommittees under the direction of a Principal Investigator: Basic and Pathological Research Subcommittee, Clinical Research Subcommittee of Small and Medium-sized Vessel Vasculitis, Clinical Research Subcommittee of Large-sized Vessel Vasculitis, and International Cooperation Research Subcommittee. Since 2008, 9 nationwide clinical studies for vasculitis have been conducted and 8 clinical and basic studies are in progress.

ClinicalCodes: an online clinical codes repository to improve the validity and reproducibility of research using electronic medical records.

PubMed

Springate, David A; Kontopantelis, Evangelos; Ashcroft, Darren M; Olier, Ivan; Parisi, Rosa; Chamapiwa, Edmore; Reeves, David

2014-01-01

Lists of clinical codes are the foundation for research undertaken using electronic medical records (EMRs). If clinical code lists are not available, reviewers are unable to determine the validity of research, full study replication is impossible, researchers are unable to make effective comparisons between studies, and the construction of new code lists is subject to much duplication of effort. Despite this, the publication of clinical codes is rarely if ever a requirement for obtaining grants, validating protocols, or publishing research. In a representative sample of 450 EMR primary research articles indexed on PubMed, we found that only 19 (5.1%) were accompanied by a full set of published clinical codes and 32 (8.6%) stated that code lists were available on request. To help address these problems, we have built an online repository where researchers using EMRs can upload and download lists of clinical codes. The repository will enable clinical researchers to better validate EMR studies, build on previous code lists and compare disease definitions across studies. It will also assist health informaticians in replicating database studies, tracking changes in disease definitions or clinical coding practice through time and sharing clinical code information across platforms and data sources as research objects.

ClinicalCodes: An Online Clinical Codes Repository to Improve the Validity and Reproducibility of Research Using Electronic Medical Records

PubMed Central

Springate, David A.; Kontopantelis, Evangelos; Ashcroft, Darren M.; Olier, Ivan; Parisi, Rosa; Chamapiwa, Edmore; Reeves, David

2014-01-01

Lists of clinical codes are the foundation for research undertaken using electronic medical records (EMRs). If clinical code lists are not available, reviewers are unable to determine the validity of research, full study replication is impossible, researchers are unable to make effective comparisons between studies, and the construction of new code lists is subject to much duplication of effort. Despite this, the publication of clinical codes is rarely if ever a requirement for obtaining grants, validating protocols, or publishing research. In a representative sample of 450 EMR primary research articles indexed on PubMed, we found that only 19 (5.1%) were accompanied by a full set of published clinical codes and 32 (8.6%) stated that code lists were available on request. To help address these problems, we have built an online repository where researchers using EMRs can upload and download lists of clinical codes. The repository will enable clinical researchers to better validate EMR studies, build on previous code lists and compare disease definitions across studies. It will also assist health informaticians in replicating database studies, tracking changes in disease definitions or clinical coding practice through time and sharing clinical code information across platforms and data sources as research objects. PMID:24941260

A systematic review of clinical outcomes in surgical treatment of adult isthmic spondylolisthesis.

PubMed

Noorian, Shaya; Sorensen, Karen; Cho, Woojin

2018-05-07

A variety of surgical methods are available for the treatment of adult isthmic spondylolisthesis, but there is no consensus regarding their relative effects on clinical outcomes. To compare the effects of different surgical techniques on clinical outcomes in adult isthmic spondylolisthesis. Systematic Review PATIENT SAMPLE: A total of 1,538 patients from six randomized clinical trials and nine observational studies comparing different surgical treatments in adult isthmic spondylolisthesis. Primary outcome measures of interest included differences in pre- versus post-surgical assessments of pain, functional disability, and overall health as assessed by validated pain rating scales and questionnaires. Secondary outcome measures of interest included intraoperative blood loss, length of hospital stay, surgery duration, reoperation rates, and complication rates. A search of the literature was performed in September, 2017 for relevant comparative studies published in the prior 10-year period in the following databases: PubMed, Embase, Web of Science, and ClinicalTrials.Gov. PRISMA guidelines were followed and studies were included/excluded based on strict predetermined criteria. Quality appraisal was conducted using the Newcastle-Ottawa Scale (NOS) for observational studies and the Cochrane Collaboration's risk of bias assessment tool for randomized clinical trials. The authors received no funding support to conduct this review. A total of 15 studies (6 randomized clinical trials and 9 observational studies) were included for full text review, a majority of which only included cases of low-grade isthmic spondylolisthesis. 1 study examined the effects of adding pedicle screw fixation (PS) to posterolateral fusion (PLF) and 2 studies examined the effects of adding reduction to interbody fusion (IF) + PS on clinical outcomes. 5 studies compared PLF, 4 with and 1 without PS, to IF + PS. Additionally, 3 studies compared circumferential fusion (IF + PS + PLF) to IF + PS and 1 study compared circumferential fusion to PLF + PS. 3 studies compared clinical outcomes among different IF + PS techniques (ALIF + PS vs. PLIF + PS vs TLIF + PS) without PLF. As per the Cochrane Collaboration's risk of bias assessment tool, 4 randomized clinical trials had an overall low risk of bias, 1 randomized clinical trial had an unclear risk of bias, and 1 randomized clinical trial had a high risk of bias. As per the Newcastle-Ottawa scale, 3 observational studies were of overall good quality, 4 observational studies were of fair quality, and 2 observational studies were of poor quality. Available studies provide strong evidence that the addition of reduction to fusion does not result in better clinical outcomes of pain and function in low-grade isthmic spondylolisthesis. Evidence also suggests that there is no significant difference between interbody fusion (IF + PS) and posterior fusion (PLF +/- PS) in outcomes of pain, function, and complication rates at follow-up points up to approximately 3 years in cases of low-grade slips. However, studies with longer follow-up points suggest that interbody fusion (IF + PS) may perform better in these same measures at later follow-up points. Available evidence also suggests no difference between circumferential fusion (IF + PS + PLF) and interbody fusion (IF + PS) in outcomes of pain and function in low-grade slips, but circumferential fusion has been associated with greater intraoperative blood loss, longer surgery duration, and longer hospital stays. In terms of clinical outcomes, insufficient evidence is available to assess the utility of adding PS to PLF, the relative efficacy of different interbody fusion (IF + PS) techniques (ALIF + PS vs. TLIF + PS vs. PLIF + PS), and the relative efficacy of circumferential fusion and posterior fusion (PLF + PS). Copyright © 2018. Published by Elsevier Inc.

Participants with schizophrenia retain the information necessary for informed consent during clinical trials

PubMed Central

Fischer, Bernard A.; McMahon, Robert P.; Meyer, Walter A.; Slack, Daniel J.; Appelbaum, Paul S.; Carpenter, William T.

2015-01-01

Objective Cognitive impairment is a characteristic of schizophrenia. This impairment may affect the retention of information required for ongoing knowledgeable participation in clinical trials. This study monitored retention of study-related knowledge--including assessment of therapeutic misconception--in people with stable, DSM-IV schizophrenia during participation in placebo-controlled clinical trials of adjunctive agents. Stability was defined as being on an antipsychotic with no change in medication or dose over the previous 4 weeks. Method Individuals enrolling in one of seven clinical trials were approached for participation. Participants came from research clinics and community mental health centers. At baseline, clinical trial consent forms were reviewed and study knowledge assessed. Participants were randomized to follow-up assessments at weeks 1, 4, and 8; weeks 4 and 8; or at week 8 only. Clinical trial consent forms were not re-reviewed at any follow-up visit. Results Fifty-nine participants were enrolled; analysis included 52 participants with at least one follow-up visit. Study knowledge did not decrease meaningfully in any group. Therapeutic misconception was not observed in participants during the study. The group assessed most frequently demonstrated significant improvement over baseline (t44= 3.43, p= 0.001). Retention of study knowledge was not related to symptoms, but had a weak correlation with cognitive capacity (R= 0.28, p= 0.07). Performance did not differ between participants from research clinics and those from community mental health centers. Conclusions Clinically-stable people with schizophrenia enrolling in a placebo-controlled adjunctive medication study, once determined to have capacity to consent to a clinical trial, retained appropriate study knowledge for at least 8 weeks. In the absence of a specific reason to suspect a loss of decisional capacity, there appears to be no need to routinely re-evaluate participants during this type of clinical trial. PMID:23842013

A Feasibility Study of a Web Based Performance Improvement System for Substance Abuse Treatment Providers

PubMed Central

Forman, Robert; Crits-Christoph, Paul; Kaynak, Övgü; Worley, Matt; Hantula, Donald A.; Kulaga, Agatha; Rotrosen, John; Chu, Melissa; Gallop, Robert; Potter, Jennifer; Muchowski, Patrice; Brower, Kirk; Strobbe, Stephen; Magruder, Kathy; Chellis, A’Delle H.; Clodfelter, Tad; Cawley, Margaret

2007-01-01

We report here on the feasibility of implementing a semi-automated performance improvement system - Patient Feedback (PF) - that enables real-time monitoring of patient ratings of therapeutic alliance, treatment satisfaction, and drug/alcohol use in outpatient substance abuse treatment clinics. The study was conducted in 6 clinics within the National Institute on Drug Abuse Clinical Trials Network. It involved a total of thirty-nine clinicians and 6 clinic supervisors. Throughout the course of the study (4 week training period, 4 week baseline, 12 week intervention, 4 week post-intervention assessment, 1 year sustainability phase) there was an overall collection rate of 75.5% of the clinic patient census. In general, the clinicians in these clinics had very positive treatment satisfaction and alliance ratings throughout the study. However, one clinic had worse drug use scores at baseline than other participating clinics, and showed a decrease in self-reported drug use at post-intervention. Although the implementation of the PF system proved to be feasible in actual clinical settings, further modifications of the PF system are needed to enhance any potential clinical usefulness. PMID:17499954

Clinical evaluation study of the German network of disorders of sex development (DSD)/intersexuality: study design, description of the study population, and data quality

PubMed Central

Lux, Anke; Kropf, Siegfried; Kleinemeier, Eva; Jürgensen, Martina; Thyen, Ute

2009-01-01

Background The German Network of Disorders of Sex Development (DSD)/Intersexuality carried out a large scale clinical evaluation study on quality of life, gender identity, treatment satisfaction, coping, and problems associated with diagnoses and therapies in individuals with disorders of sex development (DSD). DSD are a heterogeneous group of various genetic disorders of sex determination or sex differentiation, all of which are rare conditions. In about half of all cases the molecular genetic diagnosis is unknown and diagnosis rests on clinical features. Methods and design The multi-centre clinical evaluation study includes short-term follow-up in some and cross-sectional assessments in all age and diagnostic groups fitting the criteria of DSD. Recruitment was from January 2005 until December 2007 in whole Germany and, additionally, in 2007 in Austria and German-speaking Switzerland. The study consists of a psychosocial inquiry for children, adolescents and their parents, and adults with standardized instruments and the collection of DSD-specific medical data by the attending physician. The main goal was the description of clinical outcomes and the health-care situation of individuals with DSD using a broad generic definition of DSD including all conditions with a mismatch of chromosomal, gonadal and phenotypical sex. 439 children and adolescents, their parents and adults with DSD participated. Discussion The clinical evaluation study represents the most comprehensive study in this clinical field. The paper discusses the study protocol, the data management and data quality as well as the classification used, and it describes the study population. Given the lack of large datasets in rare conditions such as DSD and often biased results from small scale clinical case series, the study aims to generate concrete hypotheses for evidence-based guidelines, which should be tested in further studies. PMID:19383134

Data Linkage from Clinical to Study Databases via an R Data Warehouse User Interface. Experiences from a Large Clinical Follow-up Study.

PubMed

Kaspar, Mathias; Ertl, Maximilian; Fette, Georg; Dietrich, Georg; Toepfer, Martin; Angermann, Christiane; Störk, Stefan; Puppe, Frank

2016-08-05

Data that needs to be documented for clinical studies has often been acquired and documented in clinical routine. Usually this data is manually transferred to Case Report Forms (CRF) and/or directly into an electronic data capture (EDC) system. To enhance the documentation process of a large clinical follow-up study targeting patients admitted for acutely decompensated heart failure by accessing the data created during routine and study visits from a hospital information system (HIS) and by transferring it via a data warehouse (DWH) into the study's EDC system. This project is based on the clinical DWH developed at the University of Würzburg. The DWH was extended by several new data domains including data created by the study team itself. An R user interface was developed for the DWH that allows to access its source data in all its detail, to transform data as comprehensively as possible by R into study-specific variables and to support the creation of data and catalog tables. A data flow was established that starts with labeling patients as study patients within the HIS and proceeds with updating the DWH with this label and further data domains at a daily rate. Several study-specific variables were defined using the implemented R user interface of the DWH. This system was then used to export these variables as data tables ready for import into our EDC system. The data tables were then used to initialize the first 296 patients within the EDC system by pseudonym, visit and data values. Afterwards, these records were filled with clinical data on heart failure, vital parameters and time spent on selected wards. This solution focuses on the comprehensive access and transformation of data for a DWH-EDC system linkage. Using this system in a large clinical study has demonstrated the feasibility of this approach for a study with a complex visit schedule.

The impact of Public Reporting on clinical outcomes: a systematic review and meta-analysis.

PubMed

Campanella, Paolo; Vukovic, Vladimir; Parente, Paolo; Sulejmani, Adela; Ricciardi, Walter; Specchia, Maria Lucia

2016-07-22

To assess both qualitatively and quantitatively the impact of Public Reporting (PR) on clinical outcomes, we carried out a systematic review of published studies on this topic. Pubmed, Web of Science and SCOPUS databases were searched to identify studies published from 1991 to 2014 that investigated the relationship between PR and clinical outcomes. Studies were considered eligible if they investigated the relationship between PR and clinical outcomes and comprehensively described the PR mechanism and the study design adopted. Among the clinical outcomes identified, meta-analysis was performed for overall mortality rate which quantitative data were exhaustively reported in a sufficient number of studies. Two reviewers conducted all data extraction independently and disagreements were resolved through discussion. The same reviewers evaluated also the quality of the studies using a GRADE approach. Twenty-seven studies were included. Mainly, the effect of PR on clinical outcomes was positive. Meta-analysis regarding overall mortality included, in a context of high heterogeneity, 10 studies with a total of 1,840,401 experimental events and 3,670,446 control events and resulted in a RR of 0.85 (95 % CI, 0.79-0.92). The introduction of PR programs at different levels of the healthcare sector is a challenging but rewarding public health strategy. Existing research covering different clinical outcomes supports the idea that PR could, in fact, stimulate providers to improve healthcare quality.

77 FR 30016 - Clinical Study Design and Performance of Hospital Glucose Sensors

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

...] Clinical Study Design and Performance of Hospital Glucose Sensors AGENCY: Food and Drug Administration, HHS... Sensors.'' The purpose of this public meeting is to discuss clinical study design considerations and performance metrics for innovative glucose sensors intended to be used in hospital point of care settings...

77 FR 50548 - Agency Information Collection: (PACT Clinical Innovation Study: Engaging Caregivers in the Care...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-21

... Collection: (PACT Clinical Innovation Study: Engaging Caregivers in the Care of Veterans With Dementia... announces that the Department of Veterans Affairs (VA), will submit to the Office of Management and Budget... Form 10-0537). SUPPLEMENTARY INFORMATION: Title: PACT Clinical Innovation Study: Engaging Caregivers in...

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

PubMed

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

PubMed Central

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

How to write a surgical clinical research protocol: literature review and practical guide.

PubMed

Rosenthal, Rachel; Schäfer, Juliane; Briel, Matthias; Bucher, Heiner C; Oertli, Daniel; Dell-Kuster, Salome

2014-02-01

The study protocol is the core document of every clinical research project. Clinical research in studies involving surgical interventions presents some specific challenges, which need to be accounted for and described in the study protocol. The aim of this review is to provide a practical guide for developing a clinical study protocol for surgical interventions with a focus on methodologic issues. On the basis of an in-depth literature search of methodologic literature and on some cardinal published surgical trials and observational studies, the authors provides a 10-step guide for developing a clinical study protocol in surgery. This practical guide outlines key methodologic issues important when planning an ethically and scientifically sound research project involving surgical interventions, with the ultimate goal of providing high-level evidence relevant for health care decision making in surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

Design, development and deployment of a Diabetes Research Registry to facilitate recruitment in clinical research.

PubMed

Tan, Meng H; Bernstein, Steven J; Gendler, Stephen; Hanauer, David; Herman, William H

2016-03-01

A major challenge in conducting clinical trials/studies is the timely recruitment of eligible subjects. Our aim is to develop a Diabetes Research Registry (DRR) to facilitate recruitment by matching potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their electronic health records (EHR). A committee with expertise in diabetes, quality improvement, information technology, and informatics designed and developed the DRR. Using a hybrid approach, we identified and consented patients interested in research, abstracted their EHRs to assess common eligibility criteria, and contacted them about their interest in participating in specific studies. Investigators submit their requests with study entry criteria to the DRR which then provides a list of potential subjects who may be directly contacted for their study. The DRR meets all local, regional and federal regulatory requirements. After 5 years, the DRR has over 5000 registrants. About 30% have type 1 diabetes and 70% have type 2 diabetes. There are almost equal proportions of men and women. During this period, 31 unique clinical studies from 19 unique investigators requested lists of potential subjects for their studies. Eleven grant applications from 10 unique investigators used aggregated counts of potentially eligible subjects in their applications. The DRR matches potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their EHR. By providing large lists of potentially eligible study subjects quickly, the DRR facilitated recruitment in 31 clinical studies. Copyright © 2016 Elsevier Inc. All rights reserved.

The development and psychometric testing of a theory-based instrument to evaluate nurses' perception of clinical reasoning competence.

PubMed

Liou, Shwu-Ru; Liu, Hsiu-Chen; Tsai, Hsiu-Min; Tsai, Ying-Huang; Lin, Yu-Ching; Chang, Chia-Hao; Cheng, Ching-Yu

2016-03-01

The purpose of the study was to develop and psychometrically test the Nurses Clinical Reasoning Scale. Clinical reasoning is an essential skill for providing safe and quality patient care. Identifying pre-graduates' and nurses' needs and designing training courses to improve their clinical reasoning competence becomes a critical task. However, there is no instrument focusing on clinical reasoning in the nursing profession. Cross-sectional design was used. This study included the development of the scale, a pilot study that preliminary tested the readability and reliability of the developed scale and a main study that implemented and tested the psychometric properties of the developed scale. The Nurses Clinical Reasoning Scale was developed based on the Clinical Reasoning Model. The scale includes 15 items using a Likert five-point scale. Data were collected from 2013-2014. Two hundred and fifty-one participants comprising clinical nurses and nursing pre-graduates completed and returned the questionnaires in the main study. The instrument was tested for internal consistency and test-retest reliability. Its validity was tested with content, construct and known-groups validity. One factor emerged from the factor analysis. The known-groups validity was confirmed. The Cronbach's alpha for the entire instrument was 0·9. The reliability and validity of the Nurses Clinical Reasoning Scale were supported. The scale is a useful tool and can be easily administered for the self-assessment of clinical reasoning competence of clinical nurses and future baccalaureate nursing graduates. Study limitations and further recommendations are discussed. © 2015 John Wiley & Sons Ltd.

Enablers of and barriers to high quality clinical supervision among occupational therapists across Queensland in Australia: findings from a qualitative study.

PubMed

Martin, Priya; Kumar, Saravana; Lizarondo, Lucylynn; VanErp, Ans

2015-09-24

Health professionals practising in countries with dispersed populations such as Australia rely on clinical supervision for professional support. While there are directives and guidelines in place to govern clinical supervision, little is known about how it is actually conducted and what makes it effective. The purpose of this study was to explore the enablers of and barriers to high quality clinical supervision among occupational therapists across Queensland in Australia. This qualitative study took place as part of a broader project. Individual, in-depth, semi-structured interviews were conducted with occupational therapy supervisees in Queensland. The interviews explored the enablers of and barriers to high quality clinical supervision in this group. They further explored some findings from the initial quantitative study. Content analysis of the interview data resulted in eight themes. These themes were broadly around the importance of the supervisory relationship, the impact of clinical supervision and the enablers of and barriers to high quality clinical supervision. This study identified a number of factors that were perceived to be associated with high quality clinical supervision. Supervisor-supervisee matching and fit, supervisory relationship and availability of supervisor for support in between clinical supervision sessions appeared to be associated with perceptions of higher quality of clinical supervision received. Some face-to-face contact augmented with telesupervision was found to improve perceptions of the quality of clinical supervision received via telephone. Lastly, dual roles where clinical supervision and line management were provided by the same person were not considered desirable by supervisees. A number of enablers of and barriers to high quality clinical supervision were also identified. With clinical supervision gaining increasing prominence as part of organisational and professional governance, this study provides important lessons for successful and sustainable clinical supervision in practice contexts.

Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.

PubMed

Wallach, Joshua D; Egilman, Alexander C; Dhruva, Sanket S; McCarthy, Margaret E; Miller, Jennifer E; Woloshin, Steven; Schwartz, Lisa M; Ross, Joseph S

2018-05-24

To characterize postmarketing requirements for new drugs and biologics approved by the US Food and Drug Administration (FDA), and to examine rates and timeliness of registration, results reporting, and publication of required prospective cohort studies, registries, and clinical trials. Cross sectional analysis. Postmarketing requirements for all new drugs and biologics approved by the FDA between 1 January 2009 and 31 December 2012, with follow-up up to 15 November 2017. Postmarketing requirements and their characteristics known at the time of FDA approval, including FDA authority, study design, and study characteristics. Rates and timeliness of registration and results reporting on ClinicalTrials.gov and publication in peer reviewed journals of required prospective cohort studies, registries, and clinical trials. Between 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at least one postmarketing requirement at the time of first approval, for a total of 437 postmarketing requirements. Postmarket study descriptions were short (median word count 44 (interquartile range 29-71)) and often lacked information to determine an up to date progress (131 (30%)). 220 (50.3%) postmarketing requirements were for new animal or other studies (including pharmacokinetic studies); 134 (30.7%) were for prospective cohort studies, registries, and clinical trials; and 83 (19.0%) were for secondary analyses or follow-up studies. Of 110 clinical trials, 38 (34.5%), 44 (40.0%), 62 (56.4%), 66 (60.0%), and 98 (89.1%) did not report enough information to establish use of randomization, comparator type, allocation, outcome, and number of patients to be enrolled, respectively. Of 134 required prospective cohort studies, registries, and clinical trials, 102 (76.1%) were registered on ClinicalTrials.gov; of 50 registered and completed studies, 36 (72.0%) had reported results on ClinicalTrials.gov. Among 65 completed studies, 47 (72.3%) had either reported results or were published a median of 47 months (interquartile range 32-67) after FDA approval. 32 (68.1%) of these 47 studies did not report results publicly by the time of their original FDA report submission deadline. Postmarketing requirements for new drugs and biologics were often briefly described and did not contain enough information to characterize study designs. Approximately three quarters of postmarketing requirements for prospective cohort studies, registries, and clinical trials were registered on ClinicalTrials.gov, and nearly three quarters of completed studies reported results or were published, suggesting that at least a quarter of these required studies are not being publicly disseminated. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Clinical Trials

MedlinePlus

Clinical trials are research studies that test how well new medical approaches work in people. Each study ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to ...

Conducting feasibilities in clinical trials: an investment to ensure a good study.

PubMed

Rajadhyaksha, Viraj

2010-07-01

Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

[Clinical relevance of periodic limb movements during sleep in obstructive sleep apnea patients].

PubMed

Iriarte, J; Alegre, M; Irimia, P; Urriza, J; Artieda, J

The periodic limb movements disorder (PLMD) is frequently associated with the obstructive sleep apnea syndrome (OSAS), but the prevalence and clinical relevance of this association have not been studied in detail. The objectives were to make a prospective study on the prevalence of PLMD in patients with OSAS, and correlate this association with clinical and respiratory parameters. Forty-two patients diagnosed with OSAS, without clinical suspicion of PLMD, underwent a polysomnographic study. Clinical symptoms and signs were evaluated with an structured questionnaire, and respiratory parameters were obtained from the nocturnal study. Periodic limb movements were found in 10 patients (24%). There were no differences in clinical parameters between both groups (with and without periodical limb movements). However, respiratory parameters were significantly worse in patients without PLMD. PLMD is very frequent in patients with OSAS, and can contribute to worsen clinical signs and symptoms in these patients independently from respiratory parameters.

Self-Reflection of Video-Recorded High-Fidelity Simulations and Development of Clinical Judgment.

PubMed

Bussard, Michelle E

2016-09-01

Nurse educators are increasingly using high-fidelity simulators to improve prelicensure nursing students' ability to develop clinical judgment. Traditionally, oral debriefing sessions have immediately followed the simulation scenarios as a method for students to connect theory to practice and therefore develop clinical judgment. Recently, video recording of the simulation scenarios is being incorporated. This qualitative, interpretive description study was conducted to identify whether self-reflection on video-recorded high-fidelity simulation (HFS) scenarios helped prelicensure nursing students to develop clinical judgment. Tanner's clinical judgment model was the framework for this study. Four themes emerged from this study: Confidence, Communication, Decision Making, and Change in Clinical Practice. This study indicated that self-reflection of video-recorded HFS scenarios is beneficial for prelicensure nursing students to develop clinical judgment. [J Nurs Educ. 2016;55(9):522-527.]. Copyright 2016, SLACK Incorporated.

Characteriation of clinical data packages using foreign data in new drug applications in Japan.

PubMed

Tanaka, M; Nagata, T

2008-09-01

The objective of this research was to characterize clinical data packages (CDPs) of new drug applications (NDAs) using foreign data based on the International Conference on Harmonization (ICH) E5 guideline. Official review reports of NDAs approved in Japan between January 1999 and April 2005 were examined. Those NDAs considered by the official reviewers to be approved based on the ICH E5 guideline (E5-NDAs) were identified and classified into six categories of approval requirements in Japan. The details of pivotal clinical efficacy studies in the CDPs were examined. Forty-one NDAs were identified as E5-NDAs. Pivotal clinical studies conducted in Japan were required by the E5-NDAs, except for nine of those in which the foreign clinical studies reduced Japanese clinical studies in the CDPs. Given the differences in approval requirements among regions, the acceptability of foreign clinical data to Japanese approval is limited.

A multicenter study: how do medical students perceive clinical learning climate?

PubMed Central

Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

2016-01-01

Background The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students’ perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Methods Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). Results The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. Conclusion The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students’ interactions in clinical settings, self-realization, mood, students’ intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve clinical learning climate. PMID:27640648

The role and potential contribution of clinical research nurses to clinical trials.

PubMed

Spilsbury, Karen; Petherick, Emily; Cullum, Nicky; Nelson, Andrea; Nixon, Jane; Mason, Su

2008-02-01

This study explores the scope and potential contribution of the Clinical Research Nurse (CRN) role to clinical trials of a nursing-specific topic. Over the past two decades, there have been increases in the numbers of nurses working as CRNs because of the increasing global demand for clinical trials. CRNs can influence the quality of clinical trials but the scope and contribution of the role to clinical trials is not known. Qualitative focus group study. A focus group interview was carried out with CRNs (n = 9) employed on a large, multi-centre (six NHS Trusts) randomized controlled trial of pressure area care. The focus group interview was recorded, alongside field notes of participant interactions and behaviours, and transcribed verbatim. Data were analysed for thematic content and process. CRNs described their transition to a clinical research role. They reported a lack of confidence, role conflict as researcher and nurse, the challenges of gaining cooperation of clinical nursing staff to comply with trial protocols and difficulties maintaining their own motivation. CRNs provided their perceptions and observations of pressure area care and prevention. They identified areas of inadequate treatment, management and care, influenced by organizational and clinical aspects of care delivery. The study reveals challenges associated with training and management of CRNs. CRNs are usually associated with trial recruitment and data collection. This study highlights the additional contributions of CRNs for the study of topics specific to nursing as the result of their unique placement in the research centres as informal 'participant observers.' Such observations enhance understanding of the contexts being studied. These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

Does clinical supervision of healthcare professionals improve effectiveness of care and patient experience? A systematic review.

PubMed

Snowdon, David A; Leggat, Sandra G; Taylor, Nicholas F

2017-11-28

To ensure quality of care delivery clinical supervision has been implemented in health services. While clinical supervision of health professionals has been shown to improve patient safety, its effect on other dimensions of quality of care is unknown. The purpose of this systematic review is to determine whether clinical supervision of health professionals improves effectiveness of care and patient experience. Databases MEDLINE, PsychINFO, CINAHL, EMBASE and AMED were searched from earliest date available. Additional studies were identified by searching of reference lists and citation tracking. Two reviewers independently applied inclusion and exclusion criteria. The quality of each study was rated using the Medical Education Research Study Quality Instrument. Data were extracted on effectiveness of care (process of care and patient health outcomes) and patient experience. Seventeen studies across multiple health professions (medical (n = 4), nursing (n = 7), allied health (n = 2) and combination of nursing, medical and/or allied health (n = 4)) met the inclusion criteria. The clinical heterogeneity of the included studies precluded meta-analysis. Twelve of 14 studies investigating 38,483 episodes of care found that clinical supervision improved the process of care. This effect was most predominant in cardiopulmonary resuscitation and African health settings. Three of six studies investigating 1756 patients found that clinical supervision improved patient health outcomes, namely neurological recovery post cardiopulmonary resuscitation (n = 1) and psychological symptom severity (n = 2). None of three studies investigating 1856 patients found that clinical supervision had an effect on patient experience. Clinical supervision of health professionals is associated with effectiveness of care. The review found significant improvement in the process of care that may improve compliance with processes that are associated with enhanced patient health outcomes. While few studies found a direct effect on patient health outcomes, when provided to mental health professionals clinical supervision may be associated with a reduction in psychological symptoms of patients diagnosed with a mental illness. There was no association found between clinical supervision and the patient experience. CRD42015029643 .

How physicians teach in the clinical setting: The embedded roles of teaching and clinical care.

PubMed

Steinert, Yvonne; Basi, Mandeep; Nugus, Peter

2017-12-01

Clinical teaching lies at the heart of medical education. However, few studies have explored the embedded nature of teaching and clinical care. The goal of this study was to examine the process of clinical teaching as it naturally, and spontaneously, unfolds in a broad range of authentic contexts with medical students and residents. This focused ethnographic study consisted of 160 hours of participant observation and field interviews with three internal medicine teams. Thematic analysis guided data organization and interpretation. Three overlapping themes emerged: the interconnectedness between clinical work and pedagogy; a multiplicity of teachers; and the influence of space and artifacts on teaching and learning. Clinical teaching, which was deeply embedded in clinical care, was influenced by the acuity of patient problems, learner needs, and the context in which teaching unfolded; it also occurred on a spectrum that included planned, opportunistic, formal, and informal teaching (and learning). Study findings suggest that clinical teaching, which is marked by an intersection between service and teaching, can be viewed as an example of work-based teaching. They also yield suggestions for the enhancement of clinical teaching in inpatient settings, faculty development, and educational policies that recognize clinical teaching and learning.

An integrated review of the correlation between critical thinking ability and clinical decision-making in nursing.

PubMed

Lee, Daphne Sk; Abdullah, Khatijah Lim; Subramanian, Pathmawathi; Bachmann, Robert Thomas; Ong, Swee Leong

2017-12-01

To explore whether there is a correlation between critical thinking ability and clinical decision-making among nurses. Critical thinking is currently considered as an essential component of nurses' professional judgement and clinical decision-making. If confirmed, nursing curricula may be revised emphasising on critical thinking with the expectation to improve clinical decision-making and thus better health care. Integrated literature review. The integrative review was carried out after a comprehensive literature search using electronic databases Ovid, EBESCO MEDLINE, EBESCO CINAHL, PROQuest and Internet search engine Google Scholar. Two hundred and 22 articles from January 1980 to end of 2015 were retrieved. All studies evaluating the relationship between critical thinking and clinical decision-making, published in English language with nurses or nursing students as the study population, were included. No qualitative studies were found investigating the relationship between critical thinking and clinical decision-making, while 10 quantitative studies met the inclusion criteria and were further evaluated using the Quality Assessment and Validity Tool. As a result, one study was excluded due to a low-quality score, with the remaining nine accepted for this review. Four of nine studies established a positive relationship between critical thinking and clinical decision-making. Another five studies did not demonstrate a significant correlation. The lack of refinement in studies' design and instrumentation were arguably the main reasons for the inconsistent results. Research studies yielded contradictory results as regard to the relationship between critical thinking and clinical decision-making; therefore, the evidence is not convincing. Future quantitative studies should have representative sample size, use critical thinking measurement tools related to the healthcare sector and evaluate the predisposition of test takers towards their willingness and ability to think. There is also a need for qualitative studies to provide a fresh approach in exploring the relationship between these variables uncovering currently unknown contributing factors. This review confirmed that evidence to support the existence of relationships between critical thinking and clinical decision-making is still unsubstantiated. Therefore, it serves as a call for nurse leaders and nursing academics to produce quality studies in order to firmly support or reject the hypothesis that there is a statistically significant correlation between critical thinking and clinical decision-making. © 2017 John Wiley & Sons Ltd.

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

PubMed

Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

2014-11-01

The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Professional Development through Clinical Supervision

ERIC Educational Resources Information Center

Farhat, Amal

2016-01-01

Studies have shown that clinical supervisory practices result in implementation of new skills in teachers' classroom performance. This study examines the impact of two clinical supervisory cycles on teachers' performance in classroom management. Multiple data collection tools were used to determine the impact of clinical supervisory interventions…

Dissemination Bias in Systematic Reviews of Animal Research: A Systematic Review

PubMed Central

Mueller, Katharina F.; Briel, Matthias; Strech, Daniel; Meerpohl, Joerg J.; Lang, Britta; Motschall, Edith; Gloy, Viktoria; Lamontagne, Francois; Bassler, Dirk

2014-01-01

Background Systematic reviews of preclinical studies, in vivo animal experiments in particular, can influence clinical research and thus even clinical care. Dissemination bias, selective dissemination of positive or significant results, is one of the major threats to validity in systematic reviews also in the realm of animal studies. We conducted a systematic review to determine the number of published systematic reviews of animal studies until present, to investigate their methodological features especially with respect to assessment of dissemination bias, and to investigate the citation of preclinical systematic reviews on clinical research. Methods Eligible studies for this systematic review constitute systematic reviews that summarize in vivo animal experiments whose results could be interpreted as applicable to clinical care. We systematically searched Ovid Medline, Embase, ToxNet, and ScienceDirect from 1st January 2009 to 9th January 2013 for eligible systematic reviews without language restrictions. Furthermore we included articles from two previous systematic reviews by Peters et al. and Korevaar et al. Results The literature search and screening process resulted in 512 included full text articles. We found an increasing number of published preclinical systematic reviews over time. The methodological quality of preclinical systematic reviews was low. The majority of preclinical systematic reviews did not assess methodological quality of the included studies (71%), nor did they assess heterogeneity (81%) or dissemination bias (87%). Statistics quantifying the importance of clinical research citing systematic reviews of animal studies showed that clinical studies referred to the preclinical research mainly to justify their study or a future study (76%). Discussion Preclinical systematic reviews may have an influence on clinical research but their methodological quality frequently remains low. Therefore, systematic reviews of animal research should be critically appraised before translating them to a clinical context. PMID:25541734

Enhancing the Alignment of the Preclinical and Clinical Stroke Recovery Research Pipeline: Consensus-Based Core Recommendations From the Stroke Recovery and Rehabilitation Roundtable Translational Working Group.

PubMed

Corbett, Dale; Carmichael, S Thomas; Murphy, Timothy H; Jones, Theresa A; Schwab, Martin E; Jolkkonen, Jukka; Clarkson, Andrew N; Dancause, Numa; Weiloch, Tadeusz; Johansen-Berg, Heidi; Nilsson, Michael; McCullough, Louise D; Joy, Mary T

2017-08-01

Stroke recovery research involves distinct biological and clinical targets compared to the study of acute stroke. Guidelines are proposed for the pre-clinical modeling of stroke recovery and for the alignment of pre-clinical studies to clinical trials in stroke recovery.

The STARD Statement for Reporting Diagnostic Accuracy Studies: Application to the History and Physical Examination

PubMed Central

Rennie, Drummond; Bossuyt, Patrick M. M.

2008-01-01

Summary Objective The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test. Setting Nonsystematic review of the STARD statement. Interventions Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus. Measurements and Main Results The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians. Conclusions The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient’s history and physical examination. PMID:18347878

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

PubMed

Zheng, Sarah Y; Dhruva, Sanket S; Redberg, Rita F

2017-08-15

High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. Panel-track supplement approval. Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were based on surrogate end points. These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved.

The transfer of theoretical knowledge to clinical practice by nursing students and the difficulties they experience: A qualitative study.

PubMed

Günay, Ulviye; Kılınç, Gülsen

2018-06-01

Nursing education contains both theoretical and practical training processes. Clinical training is the basis of nursing education. The quality of clinical training is closely related to the quality of the clinical learning environment. This study aimed to determine the transfer of theoretical knowledge into clinical practice by nursing students and the difficulties they experience during this process. A qualitative research design was used in the study. The study was conducted in 2015 with 30 nursing students in a university located in the east of Turkey, constituting three focus groups. The questions directed to the students during the focus group interviews were as follows: What do you think about your clinical training? How do you evaluate yourself in the process of putting your theoretical knowledge into clinical practice? What kind of difficulties are you experiencing in clinical practices? The data were interpreted using the method of content analysis. Most of the students reported that theoretical information they received was excessive, their ability to put most of this information into practice was weak, and they lacked courage to touch patients for fear of implementing procedures incorrectly. As a result of the analysis of the data, five main themes were determined: clinical training, guidance and communication, hospital environment and expectations. The results of this study showed that nursing students found their clinical knowledge and skills insufficient and usually failed to transfer their theoretical knowledge into clinical practices. The study observed that nursing students experienced various issues in clinical practices. In order to fix these issues and achieve an effective clinical training environment, collaboration should be achieved among nursing instructors, nurses, nursing school and hospital managements. Additionally, the number of nursing educators should be increased and training programs should be provided regarding effective clinical training methods. Copyright © 2018 Elsevier Ltd. All rights reserved.

Preliminary clinical nursing leadership competency model: a qualitative study from Thailand.

PubMed

Supamanee, Treeyaphan; Krairiksh, Marisa; Singhakhumfu, Laddawan; Turale, Sue

2011-12-01

This qualitative study explored the clinical nursing leadership competency perspectives of Thai nurses working in a university hospital. To collect data, in-depth interviews were undertaken with 23 nurse administrators, and focus groups were used with 31 registered nurses. Data were analyzed using content analysis, and theory development was guided by the Iceberg model. Nurses' clinical leadership competencies emerged, comprising hidden characteristics and surface characteristics. The hidden characteristics composed three elements: motive (respect from the nursing and healthcare team and being secure in life), self-concept (representing positive attitudes and values), and traits (personal qualities necessary for leadership). The surface characteristics comprised specific knowledge of nurse leaders about clinical leadership, management and nursing informatics, and clinical skills, such as coordination, effective communication, problem solving, and clinical decision-making. The study findings help nursing to gain greater knowledge of the essence of clinical nursing leadership competencies, a matter critical for theory development in leadership. This study's results later led to the instigation of a training program for registered nurse leaders at the study site, and the formation of a preliminary clinical nursing leadership competency model. © 2011 Blackwell Publishing Asia Pty Ltd.

Acute Respiratory Distress Syndrome Measurement Error. Potential Effect on Clinical Study Results

PubMed Central

Cooke, Colin R.; Iwashyna, Theodore J.; Hofer, Timothy P.

2016-01-01

Rationale: Identifying patients with acute respiratory distress syndrome (ARDS) is a recognized challenge. Experts often have only moderate agreement when applying the clinical definition of ARDS to patients. However, no study has fully examined the implications of low reliability measurement of ARDS on clinical studies. Objectives: To investigate how the degree of variability in ARDS measurement commonly reported in clinical studies affects study power, the accuracy of treatment effect estimates, and the measured strength of risk factor associations. Methods: We examined the effect of ARDS measurement error in randomized clinical trials (RCTs) of ARDS-specific treatments and cohort studies using simulations. We varied the reliability of ARDS diagnosis, quantified as the interobserver reliability (κ-statistic) between two reviewers. In RCT simulations, patients identified as having ARDS were enrolled, and when measurement error was present, patients without ARDS could be enrolled. In cohort studies, risk factors as potential predictors were analyzed using reviewer-identified ARDS as the outcome variable. Measurements and Main Results: Lower reliability measurement of ARDS during patient enrollment in RCTs seriously degraded study power. Holding effect size constant, the sample size necessary to attain adequate statistical power increased by more than 50% as reliability declined, although the result was sensitive to ARDS prevalence. In a 1,400-patient clinical trial, the sample size necessary to maintain similar statistical power increased to over 1,900 when reliability declined from perfect to substantial (κ = 0.72). Lower reliability measurement diminished the apparent effectiveness of an ARDS-specific treatment from a 15.2% (95% confidence interval, 9.4–20.9%) absolute risk reduction in mortality to 10.9% (95% confidence interval, 4.7–16.2%) when reliability declined to moderate (κ = 0.51). In cohort studies, the effect on risk factor associations was similar. Conclusions: ARDS measurement error can seriously degrade statistical power and effect size estimates of clinical studies. The reliability of ARDS measurement warrants careful attention in future ARDS clinical studies. PMID:27159648

A systematic review of clinical assessment for undergraduate nursing students.

PubMed

Wu, Xi Vivien; Enskär, Karin; Lee, Cindy Ching Siang; Wang, Wenru

2015-02-01

Consolidated clinical practicum prepares pre-registration nursing students to function as beginning practitioners. The clinical competencies of final-year nursing students provide a key indication of professional standards of practice and patient safety. Thus, clinical assessment of nursing students is a crucial issue for educators and administrators. The aim of this systematic review was to explore the clinical competency assessment for undergraduate nursing students. PubMed, CINAHL, ScienceDirect, Web of Science, and EBSCO were systematically searched from January 2000 to December 2013. The systematic review was in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Published quantitative and qualitative studies that examined clinical assessment practices and tools used in clinical nursing education were retrieved. Quality assessment, data extraction, and analysis were completed on all included studies. This review screened 2073 titles, abstracts and full-text records, resulting in 33 included studies. Two reviewers assessed the quality of the included studies. Fourteen quantitative and qualitative studies were identified for this evaluation. The evidence was ordered into emergent themes; the overarching themes were current practices in clinical assessment, issues of learning and assessment, development of assessment tools, and reliability and validity of assessment tools. There is a need to develop a holistic clinical assessment tool with reasonable level of validity and reliability. Clinical assessment is a robust activity and requires collaboration between clinical partners and academia to enhance the clinical experiences of students, the professional development of preceptors, and the clinical credibility of academics. Copyright © 2014 Elsevier Ltd. All rights reserved.

77 FR 31027 - Submission for OMB Review; Comment Request; Web-Based Assessment of the Clinical Studies Support...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-24

...; Comment Request; Web-Based Assessment of the Clinical Studies Support Center (CSSC) Summary: Under the... current valid OMB control number. Proposed Collection: Title: Web-Based Assessment of the Clinical Studies... Operations and Procedures (MOP); coordinating meeting space and logistics for in-person meetings, Web...

An Alternative Study of Transfer of Learning in Clinical Evaluation.

ERIC Educational Resources Information Center

Patel, Vimla; Cranton, Patricia A.

The use of an alternative methodology to study transfer of learning in clinical instruction during medical school was investigated. The environment in which clinical instruction takes place was examined, after which hypotheses were proposed and tested in a quasi-experimental design. The first phase of the study, an ethnographic analysis of the…

Candida species isolation in peristomal skin in patients with abdominal stomas and correlation to clinical signs: a descriptive pilot study.

PubMed

Morales-Mendoza, Yamilett; Fernández-Martínez, Ramón; Fabián-Victoriano, Ma Rosy; Contreras-Ruiz, José; Vásquez-del-Mercado, Elsa; de Lourdes Suárez-Roa, Maria; Arenas-Guzman, Roberto

2014-11-01

The reported prevalence of candidiasis in peristomal skin varies greatly. Very few studies exist that correlate the clinical findings around the peristomal skin to the mycology. In this study, the authors report on Candida species prevalence, clinical correlation, and mycology.

Nurse leaders' perceptions of the ethical recruitment of study subjects in clinical research.

PubMed

Nurmi, Sanna-Maria; Pietilä, Anna-Maija; Kangasniemi, Mari; Halkoaho, Arja

2015-11-01

The aim of this study was to describe nurse leaders' perceptions of ethical recruitment in clinical research. Nurse leaders are expected to get involved in clinical research, but there are few studies that focus on their role, particularly the ethical issues. Qualitative data were collected from ten nurse leaders using thematic one-to-one interviews and analysed with content analysis. Nurse leaders considered clinical research at their workplace in relation to the key issues that enabled ethical recruitment of study subjects in clinical research. These were: early information and collaboration for incorporating clinical research in everyday work, an opportune and peaceful recruitment moment and positive research culture. Getting involved in clinical research is part of the nurse leader's professional responsibility in current health care. They have an essential role to play in ensuring that recruitment is ethical and that the dignity of study subjects is maintained. The duty of nurse leaders is to maintain good contact with other collaborators and to ensure good conditions for implementing clinical research at their site. This requires a comprehensive understanding of the overall situation on their wards. Implementing clinical research requires careful planning, together with educating, supporting and motivating nursing staff. © 2014 John Wiley & Sons Ltd.

Influence networks among substance abuse treatment clinics: implications for the dissemination of innovations.

PubMed

Johnson, Kimberly; Quanbeck, Andrew; Maus, Adam; Gustafson, David H; Dearing, James W

2015-09-01

Understanding influence networks among substance abuse treatment clinics may speed the diffusion of innovations. The purpose of this study was to describe influence networks in Massachusetts, Michigan, New York, Oregon, and Washington and test two expectations, using social network analysis: (1) Social network measures can identify influential clinics; and (2) Within a network, some weakly connected clinics access out-of-network sources of innovative evidence-based practices and can spread these innovations through the network. A survey of 201 clinics in a parent study on quality improvement provided the data. Network measures and sociograms were obtained from adjacency matrixes created by UCINet. We used regression analysis to determine whether network status relates to clinics' adopting innovations. Findings suggest that influential clinics can be identified and that loosely linked clinics were likely to join the study sooner than more influential clinics but were not more likely to have improved outcomes than other organizations. Findings identify the structure of influence networks for SUD treatment organizations and have mixed results on how those structures impacted diffusion of the intervention under study. Further study is necessary to test whether use of knowledge of the network structure will have an effect on the pace and breadth of dissemination of innovations.

Safe clinical practice for patients hospitalised in a suicidal crisis: a study protocol for a qualitative case study

PubMed Central

Berg, Siv Hilde; Rørtveit, Kristine; Walby, Fredrik A; Aase, Karina

2017-01-01

Introduction Suicide prevention in psychiatric care is arguably complex and incompletely understood as a patient safety issue. A resilient healthcare approach provides perspectives through which to understand this complexity by understanding everyday clinical practice. By including suicidal patients and healthcare professionals as sources of knowledge, a deeper understanding of what constitutes safe clinical practice can be achieved. Methods This planned study aims to adopt the perspective of resilient healthcare to provide a deeper understanding of safe clinical practice for suicidal patients in psychiatric inpatient care. It will describe the experienced components and conditions of safe clinical practice and the experienced practice of patient safety. The study will apply a descriptive case study approach consisting of qualitative semistructured interviews and focus groups. The data sources are hospitalised patients in a suicidal crisis and healthcare professionals in clinical practice. Ethics and dissemination This study was approved by the Regional Ethics Committee (2016/34). The results will be disseminated through scientific articles, a PhD dissertation, and national and international conferences. These findings can generate knowledge to be integrated into the practice of safety for suicidal inpatients in Norway and to improve the feasibility of patient safety measures. Theoretical generalisations can be drawn regarding safe clinical practice by taking into account the experiences of patients and healthcare professionals. Thus, this study can inform the conceptual development of safe clinical practice for suicidal patients. PMID:28132001

Childhood bullying and the association with psychosis in non-clinical and clinical samples: a review and meta-analysis.

PubMed

van Dam, D S; van der Ven, E; Velthorst, E; Selten, J P; Morgan, C; de Haan, L

2012-12-01

Approximately 11% of schoolchildren are bullied on a regular basis. It has been argued that continuous exposure to stress is related to the development of psychotic symptoms. The current study sought to investigate whether being bullied in childhood is related to the development of psychotic symptoms. A search of PubMed, PsycINFO and EMBASE was conducted. The reference lists of included papers were searched to identify other eligible papers. A meta-analysis was performed on a subgroup of studies. We found four clinical and 10 general population studies that met inclusion criteria. The results of the clinical studies were mixed. However, the results of the non-clinical studies provided more consistent evidence that school bullying is related to the development of non-clinical psychotic symptoms. Stronger associations were found with increased frequency and severity and longer duration of being bullied. We performed a meta-analysis on seven population-based studies, yielding unadjusted and adjusted odds ratios (ORs) of 2.7 [95% confidence interval (CI) 2.1-3.6] and 2.3 (95% CI 1.5-3.4) respectively. Although there is some evidence of an association between bullying and psychosis in clinical samples, the research is too sparse to draw any firm conclusions. However, population-based non-clinical studies support the role of bullying in the development of psychotic symptoms later in life. These findings are consistent with findings of an increased risk of psychotic symptoms among those exposed to other types of abuse.

Exploring Organizational Barriers to Strengthening Clinical Supervision of Psychiatric Nursing Staff: A Longitudinal Controlled Intervention Study.

PubMed

Gonge, Henrik; Buus, Niels

2016-05-01

This article reports findings from a longitudinal controlled intervention study of 115 psychiatric nursing staff. The twofold objective of the study was: (a) To test whether the intervention could increase clinical supervision participation and effectiveness of existing supervision practices, and (b) To explore organizational constraints to implementation of these strengthened practices. Questionnaire responses and registration of participation in clinical supervision were registered prior and subsequent to the intervention consisting of an action learning oriented reflection on staff's existing clinical supervision practices. Major organizational changes in the intervention group during the study period obstructed the implementation of strengthened clinical supervision practices, but offered an opportunity for studying the influences of organizational constraints. The main findings were that a) diminishing experience of social support from colleagues was associated with reduced participation in clinical supervision, while b) additional quantitative demands were associated with staff reporting difficulties finding time for supervision. This probably explained a negative development in the experienced effectiveness of supervision. It is concluded that organizational support is an imperative for implementation of clinical supervision.

[Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

PubMed

Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

2015-06-01

The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

Religion, Spirituality, and HIV Clinical Outcomes: A Systematic Review of the Literature.

PubMed

Doolittle, B R; Justice, A C; Fiellin, D A

2018-06-01

This systematic review evaluates the association between religion, spirituality and clinical outcomes in HIV-infected individuals. A systematic literature review was conducted for all English language articles published between 1980 and 2016 in relevant databases. Six hundred fourteen studies were evaluated. 15 met inclusion criteria. Ten (67%) studies reported a positive association between religion or spirituality and a clinical HIV outcome. Two (13%) studies failed to detect such an association; and two (13%) demonstrated a negative association. One study (7%) identified features of religiosity and spirituality that had both negative and positive associations with HIV clinical outcomes. Recognizing the religious or spiritual commitments of patients may serve as an important component of patient care. Further longitudinal studies and interventions might be required to further clarify the potential impact of religion and spirituality on HIV clinical outcomes.

Women's Health and Complementary Approaches

MedlinePlus

... Information Center Ongoing Medical Studies Find Active Medical Research Studies on Cranberry (ClinicalTrials.gov) Find Active Medical Research Studies on Menopause (ClinicalTrials.gov) Safety Information Dream Body ...

Editorial--Avoiding Unethical Helicobacter pylori Clinical Trials: Susceptibility-Based Studies and Probiotics as Adjuvants.

PubMed

Graham, David Y

2015-10-01

As a general rule, any clinical study where the result is already known or when the investigator(s) compares an assigned treatment against another assigned treatment known to be ineffective in the study population (e.g., in a population with known clarithromycin resistance) is unethical. As susceptibility-based therapy will always be superior to empiric therapy in any population with a prevalence of antimicrobial resistance >0%, any trial that randomizes susceptibility-based therapy with empiric therapy would be unethical. The journal Helicobacter welcomes susceptibility or culture-guided studies, studies of new therapies, and studies of adjuvants and probiotics. However, the journal will not accept for review any study we judge to be lacking clinical equipoise or which assign subjects to a treatment known to be ineffective, such as a susceptibility-based clinical trial with an empiric therapy comparator. To assist authors, we provide examples and suggestions regarding trial design for comparative studies, for susceptibility-based studies, and for studies testing adjuvants or probiotics. © 2015 John Wiley & Sons Ltd.

Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study.

PubMed

Ramagopalan, Sreeram; Skingsley, Andrew P; Handunnetthi, Lahiru; Klingel, Michelle; Magnus, Daniel; Pakpoor, Julia; Goldacre, Ben

2014-01-01

An important principle in the good conduct of clinical trials is that a summary of the trial protocol, with a pre-defined primary outcome, should be freely available before the study commences. The clinical trials registry ClinicalTrials.gov provides one method of doing this, and once the trial is registered, any changes made to the primary outcome are documented. The objectives of this study were: to assess the proportion of registered trials on ClinicalTrials.gov that had the primary outcome changed; to assess when the primary outcome was changed in relation to the listed study start and end dates and to assess whether the primary outcome change had any relation to the study sponsor. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 25 October 2012 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Our analysis showed that 28229 of 89204 (31.7%) registered studies had their primary outcome changed.  Industry funding was associated with all primary outcome changes, odds ratio (OR)= 1.36, 95% confidence interval (CI)=1.31-1.41, p<0.001; with primary outcome changes after study start date OR=1.37, 95% CI=1.32-1.42, p<0.001; with primary outcome changes after primary completion date OR=1.84, 95% CI=1.75-1.94, p<0.001 and with primary outcome changes after study completion date OR=1.82, 95% CI=1.73-1.91, p<0.001.  Conclusions A significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. These changes are associated with funding source.

Key cost drivers of pharmaceutical clinical trials in the United States.

PubMed

Sertkaya, Aylin; Wong, Hui-Hsing; Jessup, Amber; Beleche, Trinidad

2016-04-01

The increasing cost of clinical research has significant implications for public health, as it affects drug companies' willingness to undertake clinical trials, which in turn limits patient access to novel treatments. Thus, gaining a better understanding of the key cost drivers of clinical research in the United States is important. The study which is based on a report prepared by Eastern Research Group, Inc., for the US Department of Health and Human Services, examined different factors, such as therapeutic area, patient recruitment, administrative staff, and clinical procedure expenditures, and their contribution to pharmaceutical clinical trial costs in the United States by clinical trial phase. The study used aggregate data from three proprietary databases on clinical trial costs provided by Medidata Solutions. We evaluated per-study costs across therapeutic areas by aggregating detailed (per patient and per site) cost information. We also compared average expenditures on cost drivers with the use of weighted mean and standard deviation statistics. Therapeutic area was an important determinant of clinical trial costs by phase. The average cost of a Phase 1 study conducted at a US site ranged from US$1.4 million (pain and anesthesia) to US$6.6 million (immunomodulation), including estimated site overhead and monitoring costs of the sponsoring organization. A Phase 2 study cost from US$7.0 million (cardiovascular) to US$19.6 million (hematology), whereas a Phase 3 study cost ranged from US$11.5 million (dermatology) to US$52.9 (pain and anesthesia) on average. Across all study phases and excluding estimated site overhead costs and costs for sponsors to monitor the study, the top three cost drivers of clinical trial expenditures were clinical procedure costs (15%-22% of total), administrative staff costs (11%-29% of total), and site monitoring costs (9%-14% of total). The data were from 2004 through 2012 and were not adjusted for inflation. Additionally, the databases used represented a convenience, that is, non-probability, sample and did not allow for statistically valid estimates of cost drivers. Finally, the data were from trials funded by the global pharmaceutical and biotechnology industry only. Hence, our study findings are limited to that segment. Therapeutic area being studied as well as number and types of clinical procedures involved were the key drivers of direct costs in Phase 1 through Phase 3 studies. Research shows that strategies exist for reducing the price tag of some of these major direct cost components. Therefore, to increase clinical trial efficiency and reduce costs, gaining a better understanding of the key direct cost drivers is an important step. © The Author(s) 2016.

A Pilot Study to Determine the Effect of an Educational DVD in Philippine Languages on Cancer Clinical Trial Participation among Filipinos in Hawai'i.

PubMed

Felicitas-Perkins, Jamie Q; Palalay, Melvin Paul; Cuaresma, Charlene; Ho, Reginald Cs; Chen, Moon S; Dang, Julie; Loui, William S

2017-07-01

We conducted an experimental pilot study in an oncology clinic in Honolulu, Hawai'i to determine the effect of a culturally-tailored educational DVD on cancer clinical trial participation among Filipino cancer patients. Thirty-seven patients participated in the study, with 17 randomized into the control group (ie, usual education) and 20 into the intervention group (ie, usual education plus educational DVD). Participants completed pre- and post-educational questionnaires with items asking about understanding of several cancer topics, behavioral outcomes, and attitudes regarding several treatment and physician related topics. A Fisher's exact test was conducted to explore the association between enrollment into a clinical trial and group assignment. General linear models were created to determine significant differences between study groups in post-education response scores for each questionnaire item after controlling for age, gender, education, and pre-education response scores. Two participants from the control group and three participants from the intervention group enrolled into clinical trials. Results showed no significant association between clinical trial enrollment and study group assignment ( P > .99). A significant difference was found between study groups on surety of joining the clinical trial suggested to them ( P = .013). A multilingual educational DVD to supplement clinical trial education may positively influence Filipino cancer patients to move forward with the decision to join a cancer clinical trial. However, health literacy may serve as a major barrier to actual enrollment into the particular clinical trial available to a patient.

Embedding clinical interventions into observational studies

PubMed Central

Newman, Anne B.; Avilés-Santa, M. Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm. James; Krucoff, Mitchell; Kuller, Lewis H.; Lewis, Cora E.; Robinson, Jennifer G.; Taylor, Herman; Treviño, Roberto P.; Weintraub, William

2017-01-01

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. PMID:26611435

Communicating their individual results to participants in an environmental exposure study: Insights from clinical ethics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Deck, W.; Kosatsky, T.

1999-02-01

A study measuring the uptake of chemical contaminants among sport fishers who consume fish caught in the St. Lawrence river is currently being conducted in Montreal, Canada. In this study, blood, hair, and urine collected from local sport fishers is being tested for heavy metals and persistent organochlorine chemicals. The objective of this study was to formulate a framework for determining what information to communicate to individual subjects of a study measuring biomarkers of exposure, consistent with the principles of ethical clinical and research practice. Methods consisted of review of the scope of environmental exposure studies, including the use ofmore » biomarker measurement in clinical medicine and environmental research and the relevant principles of clinical ethics and research practice. An exposure biomarker study is designed to elucidate constitutional, behavioral, and environmental determinants of tissue concentrations of exogenous substances. Ethical clinical and research practice, aiming to maximize autonomy and beneficence and to minimize harm, requires that study findings concerning the determinants of exposure be communicated to study participants. In addition, investigators should reference clinical action levels beyond which individual biomarker results are routinely communicated to participants. When biomarkers have no known relation to risk, or when levels fall below action levels, it may be preferable not co communicate individual results, if this arrangement has been formalized at the time of informed consent.« less

Assessment of the Incorporation of Patient-Centric Outcomes in Studies of Minimally Invasive Glaucoma Surgical Devices

PubMed Central

Le, Jimmy T.; Viswanathan, Shilpa; Tarver, Michelle E.; Eydelman, Malvina; Li, Tianjing

2017-01-01

IMPORTANCE Minimally invasive glaucoma surgical (MIGS) devices are one option for lowering intraocular pressure in patients with glaucoma. OBJECTIVE To examine how often existing clinical studies of MIGS devices registered on ClinicalTrials.gov measure patient-centric outcomes that patients value directly. DESIGN, SETTING, AND PARTICIPANTS We searched ClinicalTrials.gov, a registry of publicly and privately supported clinical studies, on February 20, 2015, for records of MIGS device studies involving patients with glaucoma. Two investigators independently abstracted study design and outcome details from eligible records. We classified outcomes as patient-centric or not patient-centric using a prespecified definition. MAIN OUTCOMES AND MEASURES Proportion of patient-centric and nonpatient-centric outcomes registered on ClinicalTrials.gov. RESULTS We identified 51 eligible studies specifying 127 outcomes. Reduction in intraocular pressure was the most frequent outcome specified (78/127; 61%) and a primary outcome in 41 studies. Patient-centric outcomes—such as adverse events (n = 19; 15%), topical medication use (n = 16; 13%), visual acuity (n = 4; 3%), and health-related quality of life (n = 1; 1%)—were less frequently specified (n = 40; 32%) and a primary outcome in only 12 studies. CONCLUSION AND RELEVANCE Patient-centric outcomes that provide insight into the relative desirability and acceptability of the benefits and risks of MIGS devices are not well represented in current clinical studies. PMID:27389667

Using dreams to assess clinical change during treatment.

PubMed

Glucksman, Myron L; Kramer, Milton

2004-01-01

This article describes several studies that examine the relationship between the manifest content of selected dreams reported by patients and their clinical progress during psychoanalytic and psychodynamically oriented treatment. There are a number of elements that dreaming and psychotherapy have in common: affect regulation; conflict resolution; problem-solving; self-awareness; mastery and adaptation. Four different studies examined the relationship between the manifest content of selected dreams and clinical progress during treatment. In each study, the ratings of manifest content and clinical progress by independent observers were rank-ordered and compared. In three of the four studies there was a significant correlation between the rankings of manifest content and the rankings of clinical progress. This finding suggests that the manifest content of dreams can be used as an independent variable to assess clinical progress during psychoanalytic and psychodynamically oriented treatment.

Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

PubMed

Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F; Muizelaar, J Paul; Mendelow, A David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G; Macdonald, R Loch; Diringer, Michael N; Broderick, Joseph P; Dreier, Jens P; Roos, Yvo B W E M

2010-10-01

In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies.

Using "clinical trial diaries" to track patterns of participation for serial healthy volunteers in U.S. phase I studies.

PubMed

Edelblute, Heather B; Fisher, Jill A

2015-02-01

Phase I testing of investigational drugs relies on healthy volunteers as research participants. Many U.S. healthy volunteers enroll repeatedly in clinical trials for the financial compensation. Serial participants are incentivized to ignore restrictions on their participation, and no centralized clinical trial registry prevents dual enrollment. Little is currently known about how healthy volunteers participate in studies over time, hampering the development of policies to protect this group. We detail a methodology developed as part of a longitudinal study to track in real-time healthy volunteers' Phase I participation. Illustrating these data through three case studies, we document how healthy volunteers use strategies, such as qualifying for studies at more than one clinic and traveling significant distances, to maximize their participation. Our findings suggest that "clinical trial diaries" can generate critical information about serial research participation and point to ethical issues unique to healthy volunteers' involvement in Phase I clinical trials. © The Author(s) 2015.

Explanatory Versus Pragmatic Trials: An Essential Concept in Study Design and Interpretation.

PubMed

Merali, Zamir; Wilson, Jefferson R

2017-11-01

Randomized clinical trials often represent the highest level of clinical evidence available to evaluate the efficacy of an intervention in clinical medicine. Although the process of randomization serves to maximize internal validity, the external validity, or generalizability, of such studies depends on several factors determined at the design phase of the trial including eligibility criteria, study setting, and outcomes of interest. In general, explanatory trials are optimized to demonstrate the efficacy of an intervention in a highly selected patient group; however, findings from these studies may not be generalizable to the larger clinical problem. In contrast, pragmatic trials attempt to understand the real-world benefit of an intervention by incorporating design elements that allow for greater generalizability and clinical applicability of study results. In this article we describe the explanatory-pragmatic continuum for clinical trials in greater detail. Further, a well-accepted tool for grading trials on this continuum is described, and applied, to 2 recently published trials pertaining to the surgical management of lumbar degenerative spondylolisthesis.

Malaria Diagnostics in Clinical Trials

PubMed Central

Murphy, Sean C.; Shott, Joseph P.; Parikh, Sunil; Etter, Paige; Prescott, William R.; Stewart, V. Ann

2013-01-01

Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wide array of available malaria diagnostic tests for their suitability for screening trial participants and/or obtaining study endpoints for malaria clinical trials, including studies of HIV/malaria co-infection and other malaria natural history studies. The MLN provides recommendations on microscopy, rapid diagnostic tests, serologic tests, and molecular assays to guide selection of the most appropriate test(s) for specific research objectives. In addition, this report provides recommendations regarding quality management to ensure reproducibility across sites in clinical trials. Performance evaluation, quality control, and external quality assessment are critical processes that must be implemented in all clinical trials using malaria tests. PMID:24062484

Nursing students' perceptions of their clinical learning environment in placements outside traditional hospital settings.

PubMed

Bjørk, Ida T; Berntsen, Karin; Brynildsen, Grethe; Hestetun, Margrete

2014-10-01

To explore students' opinions of the learning environment during clinical placement in settings outside traditional hospital settings. Clinical placement experiences may influence positively on nursing students attitudes towards the clinical setting in question. Most studies exploring the quality of clinical placements have targeted students' experience in hospital settings. The number of studies exploring students' experiences of the learning environment in healthcare settings outside of the hospital venue does not match the growing importance of such settings in the delivery of health care, nor the growing number of nurses needed in these venues. A survey design was used. The Clinical Learning Environment Inventory was administered to two cohorts of undergraduate nursing students (n = 184) after clinical placement in mental health care, home care and nursing home care. Nursing students' overall contentment with the learning environment was quite similar across all three placement areas. Students in mental health care had significantly higher scores on the subscale individualisation, and older students had significantly higher scores on the total scale. Compared with other studies where the Clinical Learning Environment Inventory has been used, the students' total scores in this study are similar or higher than scores in studies including students from hospital settings. Results from this study negate the negative views on clinical placements outside the hospital setting, especially those related to placements in nursing homes and mental healthcare settings. Students' experience of the learning environment during placements in mental health care, home care and nursing homes indicates the relevance of clinical education in settings outside the hospital setting. © 2014 The Authors. Journal of Clinical Nursing published by John Wiley & Sons Ltd.

Nursing students' perceptions of their clinical learning environment in placements outside traditional hospital settings

PubMed Central

Bjørk, Ida T; Berntsen, Karin; Brynildsen, Grethe; Hestetun, Margrete

2014-01-01

Aims and objectives To explore students' opinions of the learning environment during clinical placement in settings outside traditional hospital settings. Background Clinical placement experiences may influence positively on nursing students attitudes towards the clinical setting in question. Most studies exploring the quality of clinical placements have targeted students' experience in hospital settings. The number of studies exploring students' experiences of the learning environment in healthcare settings outside of the hospital venue does not match the growing importance of such settings in the delivery of health care, nor the growing number of nurses needed in these venues. Design A survey design was used. Method The Clinical Learning Environment Inventory was administered to two cohorts of undergraduate nursing students (n = 184) after clinical placement in mental health care, home care and nursing home care. Results Nursing students' overall contentment with the learning environment was quite similar across all three placement areas. Students in mental health care had significantly higher scores on the subscale individualisation, and older students had significantly higher scores on the total scale. Compared with other studies where the Clinical Learning Environment Inventory has been used, the students' total scores in this study are similar or higher than scores in studies including students from hospital settings. Conclusion Results from this study negate the negative views on clinical placements outside the hospital setting, especially those related to placements in nursing homes and mental healthcare settings. Relevance to clinical practice Students' experience of the learning environment during placements in mental health care, home care and nursing homes indicates the relevance of clinical education in settings outside the hospital setting. PMID:24460862

Factors affecting Korean nursing student empowerment in clinical practice.

PubMed

Ahn, Yang-Heui; Choi, Jihea

2015-12-01

Understanding the phenomenon of nursing student empowerment in clinical practice is important. Investigating the cognition of empowerment and identifying predictors are necessary to enhance nursing student empowerment in clinical practice. To identify empowerment predictors for Korean nursing students in clinical practice based on studies by Bradbury-Jones et al. and Spreitzer. A cross-sectional design was used for this study. This study was performed in three nursing colleges in Korea, all of which had similar baccalaureate nursing curricula. Three hundred seven junior or senior nursing students completed a survey designed to measure factors that were hypothesized to influence nursing student empowerment in clinical practice. Data were collected from November to December 2011. Study variables included self-esteem, clinical decision making, being valued as a learner, satisfaction regarding practice with a team member, perception on professor/instructor/clinical preceptor attitude, and total number of clinical practice fields. Data were analyzed using stepwise multiple regression analyses. All of the hypothesized study variables were significantly correlated to nursing student empowerment. Stepwise multiple regression analysis revealed that clinical decision making in nursing (t=7.59, p<0.001), being valued as a learner (t=6.24, p<0.001), self-esteem (t=3.62, p<0.001), and total number of clinical practice fields (t=2.06, p=0.040). The explanatory power of these predictors was 35% (F=40.71, p<0.001). Enhancing nursing student empowerment in clinical practice will be possible by using educational strategies to improve nursing student clinical decision making. Simultaneously, attitudes of nurse educators are also important to ensure that nursing students are treated as valued learners and to increase student self-esteem in clinical practice. Finally, diverse clinical practice field environments should be considered to enhance experience. Copyright © 2015 Elsevier Ltd. All rights reserved.

Operational Efficiency of an Immunization Clinic Attached to Rural Health Training Centre in Delhi, India: A Time and Motion Study

PubMed Central

Kumar, Varun; Mangal, Abha; Panesar, Sanjeet; Yadav, Geeta; Talwar, Richa; Raut, Deepak; Singh, Saudan

2014-01-01

Background. Obtaining baseline data about current patterns of work is important for assessing the effects of interventions designed to improve care delivery. Time and motion studies allow for the most accurate measurement of structured components. Therefore, the present study was conducted to study the operational efficiency of an immunization clinic in Delhi, India. Methods. An observational cross-sectional study was conducted at the immunization clinic of Rural Health Training Centre in Delhi, India, from January 2014 to March 2014. The study composed two stage evaluations, a passive observation and a time and motion study. Systemic random sampling method was used to select 863 mothers/caregivers attending the immunization clinic. Results. At the immunization clinic, the study participants spent 64.1% of their total time in waiting. For new cases, the mean time taken for initial registration and receiving postvaccination advice was found to be significantly longer than old cases. Delivering health care services took more time during Mondays and also during the first hour of the day. Conclusion. Results of this study will guide public health decision-makers at all government levels in planning and implementation of immunization programs in developing countries. PMID:25431679

Validation of the Clinical Learning Environment Inventory.

PubMed

Chan, Dominic S

2003-08-01

One hundred eight preregistration nursing students took part in this survey study, which assessed their perceptions of the clinical learning environment. Statistical data based on the sample confirmed the reliability and validity of the Clinical Learning Environment Inventory (CLEI), which was developed using the concept of classroom learning environment studies. The study also found that there were significant differences between students' actual and preferred perceptions of the clinical learning environments. In terms of the CLEI scales, students preferred a more positive and favorable clinical environment than they perceived as being actually present. The achievement of certain outcomes of clinical field placements might be enhanced by attempting to change the actual clinical environment in ways that make it more congruent with that preferred by the students.

The Future of Clinical Education: Using the Delphi Technique to Study Allied Health Deans' Perspectives on Definitions and Goals.

PubMed

Romig, Barbara D; Tucker, Ann W; Hewitt, Anne M; O'Sullivan Maillet, Julie

2016-01-01

Allied health (AH) clinical education provides future health professionals with the experiences necessary to develop the healthcare competencies required for success in their individual fields. There is limited information and consensus on the purposes of clinical education, including its definition and goals, and its comprehensive role in AH clinical training. This study explored whether consensus could be achieved in the definition, goals, and factors impacting AH clinical education. An expert panel consisting of 61 AH deans (54.9% of the population) whose institutions were 2013 members of the Association of Schools of Allied Health Professions (ASAHP) participated in a three-round Delphi study. From July 2013 to March 2014, the deans expressed opinions about clinical education and its purposes. Responses were collected, summarized, and refined, and responses were accepted and re-rated until agreement was achieved or the study concluded. The hypothesis that AH deans would agree upon the definition and goals of clinical education was supported by this study's findings. Over 90% of deans "strongly agreed" or "agreed" on the definition of clinical education. A majority (90.2% to 92.7%) agreed with the goals. High agreement was achieved on the purposes of clinical education, resulting in a comprehensive definition of and goals for AH clinical education. The definition and goals of clinical education can be added in the healthcare literature and used in support of AH education.

The prevalence and clinical significance of maxillary sinus mucous retention cysts in a general clinic population.

PubMed

Rhodus, N L

1990-02-01

Previous studies have documented the occurrence and potential clinical significance of MSMR cysts. Studies also have alluded to a relationship between the MSMR cyst and certain signs or symptoms of disease. We determined the prevalence of MSMR cysts in a general clinic population and identified some important correlations with clinical signs and symptoms.

[Evidence-based quality assessment of 10-year orthodontic clinical trials in 4 major dental journals].

PubMed

Sun, Yan-nan; Lei, Fei-fei; Cao, Yan-li; Fu, Min-kui

2010-02-01

To assess the quality of orthodontic clinical trials published in 4 major dental journals in the past 10 years and establish the reference standard for orthodontic clinical trials and quality control of dental journals. All the clinical trials published in Chinese Journal of Stomatology, West China Journal of Stomatology, Journal of Practice Stomatology and Chinese Journal of Orthodontics from 1999 to 2008 were searched. The demographic information of the papers was extracted and the quality of the clinical trials according to the consolidated standards of reporting trials (CONSORT) was assessed. Four hundred and ninety-four clinical trials were retrieved, and 21.3% (105/494) of them were supported by grants. For the study design, only 26.1% (129/494) were prospective studies, and 3.8% (19/494) were randomized clinical trials. It was hard to evaluate precisely due to the lack of information about the details of the study designs. For the randomized clinical trials, the lack of details for randomization, allocation concealment, blinding and intention to treat compromised the quality. The general quality of clinical trials in orthodontics is poor. It needs to be improved both in the clinical study design and the paper writing.

Clinical Trials: Information and Options for People with Mood Disorders

MedlinePlus

... experts as well as nonscientists) that oversees the design of a clinical study and periodically reviews clinical research to ensure there ... Nothing is without risks, including illness itself. A study may not benefit you personally at the time of the clinical trial. You may have to ...

Individual and Composite Study Endpoints: Separating the Wheat from the Chaff

PubMed Central

Goldberg, Robert; Gore, Joel M.; Barton, Bruce; Gurwitz, Jerry

2014-01-01

We provide an overview of the individual and combined clinical endpoints and patient reported outcomes typically used in clinical trials and prospective epidemiological investigations. We discuss the strengths and limitations associated with the utilization of aggregated study endpoints and surrogate measures of important clinical endpoints and patient-centered outcomes. We hope that the points raised in this overview will lead to the collection of clinically rich, relevant, measurable, and cost-efficient study outcomes. PMID:24486289

Danish research-active clinical nurses overcome barriers in research utilization.

PubMed

Adamsen, Lis; Larsen, Kristian; Bjerregaard, Lene; Madsen, Jan K

2003-03-01

The aim of this study was to examine whether there was a difference between clinical nurses who were research-active, and clinical nurses who were nonresearch-active in utilization of research. A further aim was to identify the most significant barriers faced by a group of Danish clinical nurses in their use of research. Discrepancy between the improved quality of research results and the lack of implementing them was the starting point for a series of studies which showed the types of barriers clinical nurses found especially cumbersome when applying the research results of other researchers. This study investigates whether the clinical nurses' own engagement in research had any impact on their perception of research utilization. The study had an exploratory and descriptive design. Seventy-nine Danish clinical nurses participated and semi-structured interviewing was used as the research method. There was a statistically significant difference between the research-active and nonresearch-active nurses on various variables. The study showed that, to a larger extent, research-active nurses used evidence-based knowledge and were generally more internationally orientated. Furthermore, two important barriers for research utilization were identified by all 79 clinical nurses included in the study, i.e. 90% of the nurses explained that the quantity of research results was overwhelming, and 75% of them found that they were unable to evaluate the quality of the research. Clinical nurses, who were research-active themselves, experienced more success in overcoming some of the barriers, which existed in applying research to practice. The research potential found amongst clinical nurses in Denmark needed to be further supported through training and guidance in research methodology, establishing introductory stipends and part-time research positions. By doing so, some of the barriers affecting research utilization and the so-called theory-practice gap might be reduced. Further empirical studies, based on Giddens theory of sociological reflectivity, might see clinical nurses in a more serious light and simultaneously perceive them as producers of knowledge.

Can clinical supervision sustain our workforce in the current healthcare landscape? Findings from a Queensland study of allied health professionals.

PubMed

Saxby, Christine; Wilson, Jill; Newcombe, Peter

2015-09-01

Clinical supervision is widely recognised as a mechanism for providing professional support, professional development and clinical governance for healthcare workers. There have been limited studies about the effectiveness of clinical supervision for allied health and minimal studies conducted within the Australian health context. The aim of the present study was to identify whether clinical supervision was perceived to be effective by allied health professionals and to identify components that contributed to effectiveness. Participants completed an anonymous online questionnaire, administered through the health service's intranet. A cross-sectional study was conducted with community allied health workers (n = 82) 8 months after implementation of structured clinical supervision. Demographic data (age, gender), work-related history (profession employment level, years of experience), and supervision practice (number and length of supervision sessions) were collected through an online survey. The outcome measure, clinical supervision effectiveness, was operationalised using the Manchester Clinical Supervision Scale-26 (MCSS-26). Data were analysed with Pearson correlation (r) and independent sample t-tests (t) with significance set at 0.05 (ie the probability of significant difference set at P < 0.05). The length of the supervision sessions (r(s) ≥ 0.44), the number of sessions (r(s) ≥ 0.35) and the total period supervision had been received (r(s) ≥ 0.42) were all significantly positively correlated with the MCSS-26 domains of clinical supervision effectiveness. Three individual variables, namely 'receiving clinical supervision', 'having some choice in the allocation of clinical supervisor' and 'having a completed clinical supervision agreement', were also significantly associated with higher total MCSS-26 scores (P(s) < 0.014). The results of the study demonstrate that when clinical supervision uses best practice principles, it can provide professional support for allied health workers, even during times of rapid organisational change.

25 CFR 900.196 - Do covered services include the conduct of clinical studies and investigations and the provision...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 2 2010-04-01 2010-04-01 false Do covered services include the conduct of clinical studies and investigations and the provision of emergency services, including the operation of emergency... Claims § 900.196 Do covered services include the conduct of clinical studies and investigations and the...

Practical aspects of recruitment and retention in clinical trials of rare genetic diseases: the phenylketonuria (PKU) experience.

PubMed

DeWard, Stephanie J; Wilson, Ashley; Bausell, Heather; Volz, Ashley S; Mooney, Kimberly

2014-02-01

Bringing treatments for rare genetic diseases to patients requires clinical research. Despite increasing activism from patient support and advocacy groups to increase access to clinical research studies, connecting rare disease patients with the clinical research opportunities that may help them has proven challenging. Chief among these challenges are the low incidence of these diseases resulting in a very small pool of known patients with a particular disease, difficulty of diagnosing rare genetic diseases, logistical issues such as long distances to the nearest treatment center, and substantial disease burden leading to loss of independence. Using clinical studies of phenylketonuria as an example, this paper discusses how, based on the authors' collective experience, partnership among clinicians, patients, study coordinators, genetic counselors, dietitians, industry, patient support groups, and families can help overcome the challenges of recruiting and retaining patients in rare disease clinical trials. We discuss specific methods of collaboration, communication, and education as part of a long-term effort to build a community committed to advancing the medical care of patients with rare genetic diseases. By talking to patients and families regularly about research initiatives and taking steps to make study participation as easy as possible, rare disease clinic staff can help ensure adequate study enrollment and successful study completion.

Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol.

PubMed

Moller, David R; Koth, Laura L; Maier, Lisa A; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K; Collman, Ronald G; Hamzeh, Nabeel; Sweiss, Nadera J; Zhang, Yingze; O'Neal, Scott; Senior, Robert M; Becich, Michael; Hochheiser, Harry S; Kaminski, Naftali; Wisniewski, Stephen R; Gibson, Kevin F

2015-10-01

Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant's clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis.

Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol

PubMed Central

Koth, Laura L.; Maier, Lisa A.; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K.; Collman, Ronald G.; Hamzeh, Nabeel; Sweiss, Nadera J.; Zhang, Yingze; O’Neal, Scott; Senior, Robert M.; Becich, Michael; Hochheiser, Harry S.; Kaminski, Naftali; Wisniewski, Stephen R.; Gibson, Kevin F.

2015-01-01

Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant’s clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis. PMID:26193069

Determinants of successful clinical networks: the conceptual framework and study protocol.

PubMed

Haines, Mary; Brown, Bernadette; Craig, Jonathan; D'Este, Catherine; Elliott, Elizabeth; Klineberg, Emily; McInnes, Elizabeth; Middleton, Sandy; Paul, Christine; Redman, Sally; Yano, Elizabeth M

2012-03-13

Clinical networks are increasingly being viewed as an important strategy for increasing evidence-based practice and improving models of care, but success is variable and characteristics of networks with high impact are uncertain. This study takes advantage of the variability in the functioning and outcomes of networks supported by the Australian New South Wales (NSW) Agency for Clinical Innovation's non-mandatory model of clinical networks to investigate the factors that contribute to the success of clinical networks. The objective of this retrospective study is to examine the association between external support, organisational and program factors, and indicators of success among 19 clinical networks over a three-year period (2006-2008). The outcomes (health impact, system impact, programs implemented, engagement, user perception, and financial leverage) and explanatory factors will be collected using a web-based survey, interviews, and record review. An independent expert panel will provide judgements about the impact or extent of each network's initiatives on health and system impacts. The ratings of the expert panel will be the outcome used in multivariable analyses. Following the rating of network success, a qualitative study will be conducted to provide a more in-depth examination of the most successful networks. This is the first study to combine quantitative and qualitative methods to examine the factors that contribute to the success of clinical networks and, more generally, is the largest study of clinical networks undertaken. The adaptation of expert panel methods to rate the impacts of networks is the methodological innovation of this study. The proposed project will identify the conditions that should be established or encouraged by agencies developing clinical networks and will be of immediate use in forming strategies and programs to maximise the effectiveness of such networks.

Editorial - Avoiding unethical Helicobacter pylori clinical trials: Susceptibility-based studies and probiotics as adjuvants

PubMed Central

Graham, David Y.

2016-01-01

As a general rule, any clinical study where the result is already known or when the investigator(s) compares an assigned treatment against another assigned treatment known to be ineffective in the study population (e.g. in a population with known clarithromycin resistance) is unethical. Since susceptibility-based therapy will always be superior to empiric therapy in any population with a prevalence of antimicrobial resistance greater than 0%, any trial that randomizes susceptibility-based therapy with empiric therapy would be unethical. The journal Helicobacter welcomes susceptibility or culture-guided studies, studies of new therapies and of adjuvants and probiotics. However, the Journal will not accept for review any study we judge to be lacking clinical equipoise or which assign subjects to a treatment known to be ineffective, such as a susceptibility-based clinical trial with an empiric therapy comparator. To assist authors we provide examples and suggestion regarding trial design for comparative studies, for susceptibility-based studies, and for studies testing adjuvants or probiotics. PMID:26123529

Profiles of Urine Drug Test in Clinical Pain Patients vs Pain Research Study Subjects.

PubMed

Lee, Cheng-ting; Vo, Trang T; Cohen, Abigail S; Ahmed, Shihab; Zhang, Yi; Mao, Jianren; Chen, Lucy

2016-04-01

To examine similarities and differences in urine drug test (UDT) results in clinical pain patients and pain subjects participating in pain research studies. An observational study with retrospective chart review and data analysis. We analyzed 1,874 UDT results obtained from 1) clinical pain patients (Clinical Group; n = 1,529) and 2) pain subjects consented to participate in pain research studies (Research Group; n = 345). Since several medications such as opioids used in pain management are drugs of abuse (DOA) and can result in a positive UDT, we specifically identified those cases of positive UDT due to nonprescribed DOA and designated these cases as positive UDT with DOA (PUD). We found that 1) there was a higher rate of PUD in clinical pain patients (41.3%) than in pain research study subjects (14.8%); 2) although subjects in the Research Group were informed ahead of time that UDT will be conducted as a screening test, a substantial number (14.8%) of pain research study subjects still showed PUD; 3) there were different types of DOA between clinical pain patients (cannabinoids as the top DOA) and research study subjects (cocaine as the top DOA); and 4) a common factor associated with PUD was opioid therapy in both Clinical Group and Research Group. These results support previous findings that PUD is a common finding in clinical pain patients, particularly in those prescribed opioid therapy, and we suggest that UDT be used as routine screening testing in pain research studies. © 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Improving health outcomes for young people with long term conditions: The role of digital communication in current and future patient-clinician communication for NHS providers of specialist clinical services for young people - LYNC study protocol.

PubMed

Griffiths, Frances E; Atherton, Helen; Barker, Jack R; Cave, Jonathan Ak; Dennick, Kathryn; Dowdall, Peter; Fraser, Joe; Huxley, Caroline; Kim, Sung-Wook; Madan, Jason J; Matharu, Harjit; Musumadi, Luhanga; Palmer, Tom M; Paul, Moli; Sankaranarayanan, Sailesh; Slowther, Anne-Marie; Sujan, Mark A; Sutcliffe, Paul A; Sturt, Jackie

2015-01-01

Young people living with long term conditions are vulnerable to health service disengagement. This endangers their long term health. Studies report requests for digital forms of communication - email, text, social media - with their health care team. Digital clinical communication is troublesome for the UK NHS. In this article we aim to present the research protocol for evaluating the impacts and outcomes of digital clinical communications for young people living with long term conditions and provide critical analysis of their use, monitoring and evaluation by NHS providers (LYNC study: Long term conditions, Young people, Networked Communications). The research involves: (a) patient and public involvement activities with 16-24 year olds with and without long term health conditions; (b) six literature reviews; (c) case studies - the main empirical part of the study - and (d) synthesis and a consensus meeting. Case studies use a mixed methods design. Interviews and non-participant observation of practitioners and patients communicating in up to 20 specialist clinical settings will be combined with data, aggregated at the case level (non-identifiable patient data) on a range of clinical outcomes meaningful within the case and across cases. We will describe the use of digital clinical communication from the perspective of patients, clinical staff, support staff and managers, interviewing up to 15 young people and 15 staff per case study. Outcome data includes emergency admissions, A&E attendance and DNA (did not attend) rates. Case studies will be analysed to understand impacts of digital clinical communication on patient health outcomes, health care costs and consumption, ethics and patient safety.

A study to determine the difference in clinical judgment abilities between BSN and non-BSN graduates.

PubMed

Sanford, M; Genrich, S; Nowotny, M

1992-02-01

The purpose of this retrospective study is to determine the difference in clinical judgment abilities of recent baccalaureate nurses (BSN) seeking employment in a large metropolitan hospital and of nurses without a baccalaureate degree. Using an ex post facto design, the orientation records of 116 newly hired nurses were analyzed to determine the clinical judgment abilities using video vignettes produced by Medcom, Inc. Findings indicated that there was no difference in clinical judgment in newly hired BSN and non-BSN graduates. These findings indicate a need for more research studies to determine how clinical judgment is developed and to evaluate teaching strategies that facilitate clinical judgment.

A study of clinical nursing research priorities in aged care: a Hong Kong perspective.

PubMed

Chang, Esther; Ho, Carey Kit Bing; Yuen, Anders Chi Man; Hatcher, Deborah

2003-10-01

The aim of this study was to identify clinical research priorities in aged care from the perspectives of rehabilitation aged care nurses in Hong Kong. The Delphi method was used whereby 33 registered nurses working in an aged care rehabilitation ward identified 28 research questions pertaining to areas in which nurses could take a leadership role: clinical research that is of highest value to patients and nurse specialists; clinical research which would provide improved community care; facilitate health promotion and disease prevention and be of value to the professional needs of clinical nurses. Study findings have implications and provide direction for clinical nursing research in aged care.

From ClinicalTrials.gov trial registry to an analysis-ready database of clinical trial results.

PubMed

Cepeda, M Soledad; Lobanov, Victor; Berlin, Jesse A

2013-04-01

The ClinicalTrials.gov web site provides a convenient interface to look up study results, but it does not allow downloading data in a format that can be readily used for quantitative analyses. To develop a system that automatically downloads study results from ClinicalTrials.gov and provides an interface to retrieve study results in a spreadsheet format ready for analysis. Sherlock(®) identifies studies by intervention, population, or outcome of interest and in seconds creates an analytic database of study results ready for analyses. The outcome classification algorithms used in Sherlock were validated against a classification by an expert. Having a database ready for analysis that can be updated automatically, dramatically extends the utility of the ClinicalTrials.gov trial registry. It increases the speed of comparative research, reduces the need for manual extraction of data, and permits answering a vast array of questions.

The FDA's role in medical device clinical studies of human subjects

NASA Astrophysics Data System (ADS)

Saviola, James

2005-03-01

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

Relationship between Dispositional Mindfulness and Substance Use: Findings from a Clinical Sample

PubMed Central

Bowen, Sarah; Enkema, Matthew C.

2014-01-01

There has been rapidly increasing interest over the past decade in the potential of mindfulness-based approaches to psychological and medical treatment, including a recent growth in the area of substance abuse. Thus, the relationship between trait mindfulness and substance use has been explored in several studies. Results, however, have been mixed. While several studies of college student populations have evinced positive correlations between levels of trait mindfulness and substance use, the opposite seems to be true in clinical samples, with multiple studies showing a negative association. The current study reviews research in both non-treatment seeking college students and in clinical samples, and examines the relationship between trait mindfulness and substance dependence in a clinical sample (N = 281). Further, the study assesses the moderating effect of avoidant coping that might explain the disparate findings in the clinical versus nonclinical samples. PMID:24290208

Health effects of intermittent fasting: hormesis or harm? A systematic review.

PubMed

Horne, Benjamin D; Muhlestein, Joseph B; Anderson, Jeffrey L

2015-08-01

Intermittent fasting, alternate-day fasting, and other forms of periodic caloric desistance are gaining popularity in the lay press and among animal research scientists. Whether clinical evidence exists for or is strong enough to support the use of such dietary regimens as health interventions is unclear. This review sought to identify rigorous, clinically relevant research studies that provide high-quality evidence that therapeutic fasting regimens are clinically beneficial to humans. A systematic review of the published literature through January 2015 was performed by using sensitive search strategies to identify randomized controlled clinical trials that evaluated the effects of fasting on either clinically relevant surrogate outcomes (e.g., weight, cholesterol) or actual clinical event endpoints [e.g., diabetes, coronary artery disease (CAD)] and any other studies that evaluated the effects of fasting on clinical event outcomes. Three randomized controlled clinical trials of fasting in humans were identified, and the results were published in 5 articles, all of which evaluated the effects of fasting on surrogate outcomes. Improvements in weight and other risk-related outcomes were found in the 3 trials. Two observational clinical outcomes studies in humans were found in which fasting was associated with a lower prevalence of CAD or diabetes diagnosis. No randomized controlled trials of fasting for clinical outcomes were identified. Clinical research studies of fasting with robust designs and high levels of clinical evidence are sparse in the literature. Whereas the few randomized controlled trials and observational clinical outcomes studies support the existence of a health benefit from fasting, substantial further research in humans is needed before the use of fasting as a health intervention can be recommended. © 2015 American Society for Nutrition.

Standardization of Clinical Assessment and Sample Collection Across All PERCH Study Sites

PubMed Central

Prosperi, Christine; Baggett, Henry C.; Brooks, W. Abdullah; Deloria Knoll, Maria; Hammitt, Laura L.; Howie, Stephen R. C.; Kotloff, Karen L.; Levine, Orin S.; Madhi, Shabir A.; Murdoch, David R.; O’Brien, Katherine L.; Thea, Donald M.; Awori, Juliet O.; Bunthi, Charatdao; DeLuca, Andrea N.; Driscoll, Amanda J.; Ebruke, Bernard E.; Goswami, Doli; Hidgon, Melissa M.; Karron, Ruth A.; Kazungu, Sidi; Kourouma, Nana; Mackenzie, Grant; Moore, David P.; Mudau, Azwifari; Mwale, Magdalene; Nahar, Kamrun; Park, Daniel E.; Piralam, Barameht; Seidenberg, Phil; Sylla, Mamadou; Feikin, Daniel R.; Scott, J. Anthony G.; O’Brien, Katherine L.; Levine, Orin S.; Knoll, Maria Deloria; Feikin, Daniel R.; DeLuca, Andrea N.; Driscoll, Amanda J.; Fancourt, Nicholas; Fu, Wei; Hammitt, Laura L.; Higdon, Melissa M.; Kagucia, E. Wangeci; Karron, Ruth A.; Li, Mengying; Park, Daniel E.; Prosperi, Christine; Wu, Zhenke; Zeger, Scott L.; Watson, Nora L.; Crawley, Jane; Murdoch, David R.; Brooks, W. Abdullah; Endtz, Hubert P.; Zaman, Khalequ; Goswami, Doli; Hossain, Lokman; Jahan, Yasmin; Ashraf, Hasan; Howie, Stephen R. C.; Ebruke, Bernard E.; Antonio, Martin; McLellan, Jessica; Machuka, Eunice; Shamsul, Arifin; Zaman, Syed M.A.; Mackenzie, Grant; Scott, J. Anthony G.; Awori, Juliet O.; Morpeth, Susan C.; Kamau, Alice; Kazungu, Sidi; Kotloff, Karen L.; Tapia, Milagritos D.; Sow, Samba O.; Sylla, Mamadou; Tamboura, Boubou; Onwuchekwa, Uma; Kourouma, Nana; Toure, Aliou; Madhi, Shabir A.; Moore, David P.; Adrian, Peter V.; Baillie, Vicky L.; Kuwanda, Locadiah; Mudau, Azwifarwi; Groome, Michelle J.; Baggett, Henry C.; Thamthitiwat, Somsak; Maloney, Susan A.; Bunthi, Charatdao; Rhodes, Julia; Sawatwong, Pongpun; Akarasewi, Pasakorn; Thea, Donald M.; Mwananyanda, Lawrence; Chipeta, James; Seidenberg, Phil; Mwansa, James; wa Somwe, Somwe; Kwenda, Geoffrey

2017-01-01

Abstract Background. Variable adherence to standardized case definitions, clinical procedures, specimen collection techniques, and laboratory methods has complicated the interpretation of previous multicenter pneumonia etiology studies. To circumvent these problems, a program of clinical standardization was embedded in the Pneumonia Etiology Research for Child Health (PERCH) study. Methods. Between March 2011 and August 2013, standardized training on the PERCH case definition, clinical procedures, and collection of laboratory specimens was delivered to 331 clinical staff at 9 study sites in 7 countries (The Gambia, Kenya, Mali, South Africa, Zambia, Thailand, and Bangladesh), through 32 on-site courses and a training website. Staff competency was assessed throughout 24 months of enrollment with multiple-choice question (MCQ) examinations, a video quiz, and checklist evaluations of practical skills. Results. MCQ evaluation was confined to 158 clinical staff members who enrolled PERCH cases and controls, with scores obtained for >86% of eligible staff at each time-point. Median scores after baseline training were ≥80%, and improved by 10 percentage points with refresher training, with no significant intersite differences. Percentage agreement with the clinical trainer on the presence or absence of clinical signs on video clips was high (≥89%), with interobserver concordance being substantial to high (AC1 statistic, 0.62–0.82) for 5 of 6 signs assessed. Staff attained median scores of >90% in checklist evaluations of practical skills. Conclusions. Satisfactory clinical standardization was achieved within and across all PERCH sites, providing reassurance that any etiological or clinical differences observed across the study sites are true differences, and not attributable to differences in application of the clinical case definition, interpretation of clinical signs, or in techniques used for clinical measurements or specimen collection. PMID:28575355

Clinical Research Methodology 2: Observational Clinical Research.

PubMed

Sessler, Daniel I; Imrey, Peter B

2015-10-01

Case-control and cohort studies are invaluable research tools and provide the strongest feasible research designs for addressing some questions. Case-control studies usually involve retrospective data collection. Cohort studies can involve retrospective, ambidirectional, or prospective data collection. Observational studies are subject to errors attributable to selection bias, confounding, measurement bias, and reverse causation-in addition to errors of chance. Confounding can be statistically controlled to the extent that potential factors are known and accurately measured, but, in practice, bias and unknown confounders usually remain additional potential sources of error, often of unknown magnitude and clinical impact. Causality-the most clinically useful relation between exposure and outcome-can rarely be definitively determined from observational studies because intentional, controlled manipulations of exposures are not involved. In this article, we review several types of observational clinical research: case series, comparative case-control and cohort studies, and hybrid designs in which case-control analyses are performed on selected members of cohorts. We also discuss the analytic issues that arise when groups to be compared in an observational study, such as patients receiving different therapies, are not comparable in other respects.

Current Research Studies

MedlinePlus

... Success Home > Explore Research > Current Research Studies Current Research Studies Email Print + Share The Crohn’s & Colitis Foundation ... conducted online. Learn more about IBD Partners. Clinical Research Alliance The Clinical Research Alliance is a network ...

Clinical Study of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for Severe Pelvic Fracture and Intra Abdominal Hemorrhagic Shock using Continuous Vital Signs

DTIC Science & Technology

2016-03-01

AWARD NUMBER: W81XWH-15-1-0025 TITLE: Clinical Study of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for Severe Pelvic...Intra-Abdominal Hemorrhagic Shock 5b. GRANT NUMBER W81XWH-15-1-0025 Clinical Study of Resuscitative Endovascular Balloon Occlusion of the Aorta ...sites. Resuscitative balloon occlusion of the aorta (REBOA) has been clinically demonstrated to stop bleeding below the diaphragm. It has the potential

Culturally and linguistically diverse healthcare students' experiences of learning in a clinical environment: A systematic review of qualitative studies.

PubMed

Mikkonen, Kristina; Elo, Satu; Kuivila, Heli-Maria; Tuomikoski, Anna-Maria; Kääriäinen, Maria

2016-02-01

Learning in the clinical environment of healthcare students plays a significant part in higher education. The greatest challenges for culturally and linguistically diverse healthcare students were found in clinical placements, where differences in language and culture have been shown to cause learning obstacles for students. There has been no systematic review conducted to examine culturally and linguistically diverse healthcare students' experiences of their learning in the clinical environment. This systematic review aims to identify culturally and linguistically diverse healthcare students' experiences of learning in a clinical environment. The search strategy followed the guidelines of the Centre of Reviews and Dissemination. The original studies were identified from seven databases (CINAHL, Medline Ovid, Scopus, Web of Science, Academic Search Premiere, Eric and Cochrane Library) for the period 2000-2014. Two researchers selected studies based on titles, abstracts and full texts using inclusion criteria and assessed the quality of studies independently. Twelve original studies were chosen for the review. The culturally and linguistically diverse healthcare students' learning experiences were divided into three influential aspects of learning in a clinical environment: experiences with implementation processes and provision; experiences with peers and mentors; and experiences with university support and instructions. The main findings indicate that culturally and linguistically diverse healthcare students embarking on clinical placements initially find integration stressful. Implementing the process of learning in a clinical environment requires additional time, well prepared pedagogical orientation, prior cultural and language education, and support for students and clinical staff. Barriers to learning by culturally and linguistically diverse healthcare students were not being recognized and individuals were not considered motivated; learners experienced the strain of being different, and faced language difficulties. Clinical staff attitudes influenced students' clinical learning experiences and outcomes. Additional education in culture and language for students and clinical staff is considered essential to improve the clinical learning experiences of culturally and linguistically diverse healthcare students. Further studies of culturally and linguistically diverse healthcare students' learning experiences in the clinical environment need to be conducted in order to examine influential aspects on the clinical learning found in the review. Copyright © 2015 Elsevier Ltd. All rights reserved.

Prevention or treatment of ARDS with aspirin: a review of preclinical models and meta- analysis of clinical studies

PubMed Central

Panka, Bernardo Amisa; de Grooth, Harm-Jan; Spoelstra–de Man, Angeliquè; Looney, Mark; Tuinman, Pieter-Roel

2016-01-01

Background The acute respiratory distress syndrome (ARDS) is a life-threating disorder that contributes significantly to critical illness. No specific pharmacological interventions directed at lung injury itself, have proven effective in improving outcome of patients with ARDS. Platelet activation was identified as a key component in ARDS pathophysiology and may provide an opportunity for preventive and therapeutic strategies. We hypothesize that use of acetyl salicylic acid (ASA) may prevent and/or attenuate lung injury. Methods We conducted a systematic review of preclinical studies and meta-analysis of clinical studies investigating the efficacy of ASA in the setting of lung injury. MEDLINE, EMBASE AND COCHRANE databases were searched. Results The literature search yielded 1314 unique articles. Fifteen pre-clinical studies and eight clinical studies fulfilled the in- and exclusion criteria. In the animal studies, the overall effect of ASA was positive, e.g. ASA improved survival and attenuated inflammation and pulmonary edema. Mechanisms of actions involved, among others, are interference with the neutrophil-platelets interaction, reduction of leukotrienes, neutrophil extracellular traps and prostaglandins. High dose ASA may be the drug of choice. A meta-analysis of 3 clinical studies showed an association between ASA use and a reduced incidence of ARDS (OR 0.59, 95% CI 0.36–0.98), albeit with substantial between-study heterogeneity. All studies had their own shortcomings in methodological quality. Conclusion This systematic review of preclinical studies and meta-analysis of clinical studies suggests a beneficial role for ASA in ARDS prevention and treatment. However, the currently available data is insufficient to justify an indication for ASA in ARDS. The body of literature does support further studies in humans. We suggest clinical trials in which the mechanisms of action of ASA in lung injury models is being evaluated to guide optimal timing and dose, before prospective randomized trials. PMID:27984533

Surgical simulation training in orthopedics: current insights.

PubMed

Kalun, Portia; Wagner, Natalie; Yan, James; Nousiainen, Markku T; Sonnadara, Ranil R

2018-01-01

While the knowledge required of residents training in orthopedic surgery continues to increase, various factors, including reductions in work hours, have resulted in decreased clinical learning opportunities. Recent work suggests residents graduate from their training programs without sufficient exposure to key procedures. In response, simulation is increasingly being incorporated into training programs to supplement clinical learning. This paper reviews the literature to explore whether skills learned in simulation-based settings results in improved clinical performance in orthopedic surgery trainees. A scoping review of the literature was conducted to identify papers discussing simulation training in orthopedic surgery. We focused on exploring whether skills learned in simulation transferred effectively to a clinical setting. Experimental studies, systematic reviews, and narrative reviews were included. A total of 15 studies were included, with 11 review papers and four experimental studies. The review articles reported little evidence regarding the transfer of skills from simulation to the clinical setting, strong evidence that simulator models discriminate among different levels of experience, varied outcome measures among studies, and a need to define competent performance in both simulated and clinical settings. Furthermore, while three out of the four experimental studies demonstrated transfer between the simulated and clinical environments, methodological study design issues were identified. Our review identifies weak evidence as to whether skills learned in simulation transfer effectively to clinical practice for orthopedic surgery trainees. Given the increased reliance on simulation, there is an immediate need for comprehensive studies that focus on skill transfer, which will allow simulation to be incorporated effectively into orthopedic surgery training programs.

Establishing Evidence-Based Indications for Proton Therapy: An Overview of Current Clinical Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mishra, Mark V., E-mail: mmishra@umm.edu; Aggarwal, Sameer; Bentzen, Soren M.

Purpose: To review and assess ongoing proton beam therapy (PBT) clinical trials and to identify major gaps. Methods and Materials: Active PBT clinical trials were identified from (clinicaltrials.gov) and the World Health Organization International Clinical Trials Platform Registry. Data on clinical trial disease site, age group, projected patient enrollment, expected start and end dates, study type, and funding source were extracted. Results: A total of 122 active PBT clinical trials were identified, with target enrollment of >42,000 patients worldwide. Ninety-six trials (79%), with a median planned sample size of 68, were classified as interventional studies. Observational studies accounted for 21% ofmore » trials but 71% (n=29,852) of planned patient enrollment. The most common PBT clinical trials focus on gastrointestinal tract tumors (21%, n=26), tumors of the central nervous system (15%, n=18), and prostate cancer (12%, n=15). Five active studies (lung, esophagus, head and neck, prostate, breast) will randomize patients between protons and photons, and 3 will randomize patients between protons and carbon ion therapy. Conclusions: The PBT clinical trial portfolio is expanding rapidly. Although the majority of ongoing studies are interventional, the majority of patients will be accrued to observational studies. Future efforts should focus on strategies to encourage optimal patient enrollment and retention, with an emphasis on randomized, controlled trials, which will require support from third-party payers. Results of ongoing PBT studies should be evaluated in terms of comparative effectiveness, as well as incremental effectiveness and value offered by PBT in comparison with conventional radiation modalities.« less

A systematic review of the association between radiographic and clinical osteoarthritis of hip and knee.

PubMed

Kinds, M B; Welsing, P M J; Vignon, E P; Bijlsma, J W J; Viergever, M A; Marijnissen, A C A; Lafeber, F P J G

2011-07-01

There is ongoing debate on whether an association between radiographic and clinical osteoarthritis (OA) exists. We hypothesized that the inconsistency in the detection of an association might be caused by different definitions of OA, by different radiographic protocols, and by scoring methods for radiographic damage and symptoms. The goal of this study was to evaluate which methodological criteria are important to detect an association between radiographic and clinical OA of hip and knee. A literature search was performed with the keywords 'OA', 'hip', 'knee', 'radiographic', and 'clinical' and results were screened for relevant studies. Quality criteria for study characteristics and methodology were developed. Studies were classified according to these criteria and the presence of an association between radiographic and clinical OA was scored. The importance of methodological quality and patient characteristics on the presence of an association was evaluated. The literature search resulted in 39 studies describing an association between radiographic and clinical OA. The frequency of an association between radiographic and clinical OA outcome measures diminished when less quality criteria were fulfilled. Specifically the criterion for standardized outcome measures appeared important in the detection of an association. The association was not influenced by patient characteristics. Only four studies were identified that fulfilled all quality criteria and in these studies an association was found for the knee joint and an inconsistent association was found for the hip joint. Methodological quality criteria are of importance to reveal an association between radiographic and clinical OA. Copyright © 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial.

PubMed

Pontes, Caridad; Gratacós, Jordi; Torres, Ferran; Avendaño, Cristina; Sanz, Jesús; Vallano, Antoni; Juanola, Xavier; de Miguel, Eugenio; Sanmartí, Raimon; Calvo, Gonzalo

2015-08-20

Dose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice. To address this issue the Spanish Society of Rheumatology (SER) and Spanish Society of Clinical Pharmacology (SEFC) designed a 3-year multicenter, randomized, open-label, controlled clinical trial (2 years for inclusion and 1 year of follow-up). The study is expected to include 190 patients with axial spondyloarthritis on stable maintenance treatment (≥4 months) with any anti-TNF agent at doses recommended in the summary of product characteristics. Patients will be randomized to either a dose reduction arm or maintenance of the dosing regimen as per the official labelling recommendations. Randomization will be stratified according to the anti-TNF agent received before study inclusion. Patient follow-up, visit schedule, and examinations will be maintained as per normal clinical practice recommendations according to SER guidelines. The study aims to test the hypothesis of noninferiority of the dose reduction strategy compared with standard treatment. The first patients were recruited in July 2012, and study completion is scheduled for the end of April 2015. The REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical decision now made empirically. The study results may help inform clinical decisions relevant to both patients and healthcare decision makers. EudraCT 2011-005871-18 (21 December 2011).

Reducing the blame culture through clinical audit in nuclear medicine: a mixed methods study.

PubMed

Ross, P; Hubert, J; Wong, W L

2017-02-01

To identify the barriers and facilitators of doctors' engagement with clinical audit and to explore how and why these factors influenced doctors' decisions to engage with the NHS National Clinical Audit Programme. A single-embedded case study. Mixed methods sequential approach with explorative pilot study and follow-up survey. Pilot study comprised 13 semi-structured interviews with purposefully selected consultant doctors over a six-month period. Interview data coded and analysed using directed thematic content analysis with themes compared against the study's propositions. Themes derived from the pilot study informed the online survey question items. Exploratory factor analysis using STATA and descriptive statistical methods applied to summarise findings. Data triangulation techniques used to corroborate and validate findings across the different methodological techniques. NHS National PET-CT Clinical Audit Programme. Doctors reporting on the Audit Programme. Extent of engagement with clinical audit, factors that influence engagement with clinical audit. Online survey: 58/59 doctors responded (98.3%). Audit was found to be initially threatening (79%); audit was reassuring (85%); audit helped validate professional competence (93%); participation in audit improved reporting skills (76%). Three key factors accounted for 97.6% of the variance in survey responses: (1) perception of audit's usefulness, (2) a common purpose, (3) a supportive blame free culture of trust. Factor 1 influenced medical engagement most. The study documents performance feedback as a key facilitator of medical engagement with clinical audit. It found that medical engagement with clinical audit was associated with reduced levels of professional anxiety and higher levels of perceived self-efficacy.

Safe clinical practice for patients hospitalised in a suicidal crisis: a study protocol for a qualitative case study.

PubMed

Berg, Siv Hilde; Rørtveit, Kristine; Walby, Fredrik A; Aase, Karina

2017-01-27

Suicide prevention in psychiatric care is arguably complex and incompletely understood as a patient safety issue. A resilient healthcare approach provides perspectives through which to understand this complexity by understanding everyday clinical practice. By including suicidal patients and healthcare professionals as sources of knowledge, a deeper understanding of what constitutes safe clinical practice can be achieved. This planned study aims to adopt the perspective of resilient healthcare to provide a deeper understanding of safe clinical practice for suicidal patients in psychiatric inpatient care. It will describe the experienced components and conditions of safe clinical practice and the experienced practice of patient safety. The study will apply a descriptive case study approach consisting of qualitative semistructured interviews and focus groups. The data sources are hospitalised patients in a suicidal crisis and healthcare professionals in clinical practice. This study was approved by the Regional Ethics Committee (2016/34). The results will be disseminated through scientific articles, a PhD dissertation, and national and international conferences. These findings can generate knowledge to be integrated into the practice of safety for suicidal inpatients in Norway and to improve the feasibility of patient safety measures. Theoretical generalisations can be drawn regarding safe clinical practice by taking into account the experiences of patients and healthcare professionals. Thus, this study can inform the conceptual development of safe clinical practice for suicidal patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

ERPs and Psychopathology. I. Behavioral process issues.

PubMed

Roth, W T; Tecce, J J; Pfefferbaum, A; Rosenbloom, M; Callaway, E

1984-01-01

The clinical study of ERPs has an inherent defect--a self-selection of clinical populations that hampers equating of clinically defined groups on factors extraneous to the independent variables. Such ex post facto studies increase the likelihood of confounding variables in the interpretation of findings. Hence, the development of lawful relationships between clinical variables and ERPs is impeded and the fulfillment of description, explanation, prediction, and control in brain science is thwarted. Proper methodologies and theory development can increase the likelihood of establishing these lawful relationships. One methodology of potential value in the clinical application of ERPs, particularly in studies of aging, is that of divided attention. Two promising theoretical developments in the understanding of brain functioning and aging are the distraction-arousal hypothesis and the controlled-automatic attention model. The evaluation of ERPs in the study of brain-behavior relations in clinical populations might be facilitated by the differentiation of concurrent, predictive, content, and construct validities.

How Consistent Is the Clinical Diagnosis of Reading Specialists?

ERIC Educational Resources Information Center

Weisberg, Renee K.

A series of research studies on the consistency of reading specialists' diagnoses of students with reading problems have indicated that clinical agreement has been astonishingly low. To investigate which factors seem to lead to consistency in clinical diagnosis, a study was conducted based on a theory of clinical problem solving called inquiry…

Medications Development for the Treatment of Alcohol Use Disorder: Insights into the Predictive Value of Animal and Human Laboratory Models

PubMed Central

Yardley, Megan M.; Ray, Lara A.

2016-01-01

Development of effective treatments for alcohol use disorder (AUD) represents an important public health goal. This review provides a summary of completed preclinical and clinical studies testing pharmacotherapies for treatment of AUD. We discuss opportunities for improving the translation from preclinical findings to clinical trial outcomes, focusing on the validity and predictive value of animal and human laboratory models of AUD. Specifically, while preclinical studies of medications development have offered important insights into the neurobiology of the disorder and alcohol's molecular targets, limitations include the lack of standardized methods and streamlined processes whereby animal studies can readily inform human studies. Behavioral pharmacology studies provide a less expensive and valuable opportunity to assess the feasibility of a pharmacotherapy prior to initiating larger scale clinical trials by providing insights into the mechanism of the drug, which can then inform recruitment, analyses, and assessments. Summary tables are provided to illustrate the wide range of preclinical, human laboratory, and clinical studies of medications development for alcoholism. Taken together, this review highlights the challenges associated with animal paradigms, human laboratory studies and clinical trials with the overarching goal of advancing treatment development and highlighting opportunities to bridge the gap between preclinical and clinical research. PMID:26833803

Embedding clinical interventions into observational studies.

PubMed

Newman, Anne B; Avilés-Santa, M Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm James; Krucoff, Mitchell; Kuller, Lewis H; Lewis, Cora E; Robinson, Jennifer G; Taylor, Herman; Treviño, Roberto P; Weintraub, William

2016-01-01

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. Copyright © 2015. Published by Elsevier Inc.

Clinical application of microsampling versus conventional sampling techniques in the quantitative bioanalysis of antibiotics: a systematic review.

PubMed

Guerra Valero, Yarmarly C; Wallis, Steven C; Lipman, Jeffrey; Stove, Christophe; Roberts, Jason A; Parker, Suzanne L

2018-03-01

Conventional sampling techniques for clinical pharmacokinetic studies often require the removal of large blood volumes from patients. This can result in a physiological or emotional burden, particularly for neonates or pediatric patients. Antibiotic pharmacokinetic studies are typically performed on healthy adults or general ward patients. These may not account for alterations to a patient's pathophysiology and can lead to suboptimal treatment. Microsampling offers an important opportunity for clinical pharmacokinetic studies in vulnerable patient populations, where smaller sample volumes can be collected. This systematic review provides a description of currently available microsampling techniques and an overview of studies reporting the quantitation and validation of antibiotics using microsampling. A comparison of microsampling to conventional sampling in clinical studies is included.

The clinical learning environment and supervision by staff nurses: developing the instrument.

PubMed

Saarikoski, Mikko; Leino-Kilpi, Helena

2002-03-01

The aims of this study were (1) to describe students' perceptions of the clinical learning environment and clinical supervision and (2) to develop an evaluation scale by using the empirical results of this study. The data were collected using the Clinical Learning Environment and Supervision instrument (CLES). The instrument was based on the literature review of earlier studies. The derived instrument was tested empirically in a study involving nurse students (N=416) from four nursing colleges in Finland. The results demonstrated that the method of supervision, the number of separate supervision sessions and the psychological content of supervisory contact within a positive ward atmosphere are the most important variables in the students' clinical learning. The results also suggest that ward managers can create the conditions of a positive ward culture and a positive attitude towards students and their learning needs. The construct validity of the instrument was analysed by using exploratory factor analysis. The analysis indicated that the most important factor in the students' clinical learning is the supervisory relationship. The two most important factors constituting a 'good' clinical learning environment are the management style of the ward manager and the premises of nursing on the ward. The results of the factor analysis support the theoretical construction of the clinical learning environment modelled by earlier empirical studies.

Application of Platelet-Rich Plasma to Disorders of the Knee Joint

PubMed Central

Mandelbaum, Bert R.; McIlwraith, C. Wayne

2013-01-01

Importance. The promising therapeutic potential and regenerative properties of platelet-rich plasma (PRP) have rapidly led to its widespread clinical use in musculoskeletal injury and disease. Although the basic scientific rationale surrounding PRP products is compelling, the clinical application has outpaced the research. Objective. The purpose of this article is to examine the current concepts around the basic science of PRP application, different preparation systems, and clinical application of PRP in disorders in the knee. Evidence Acquisition. A systematic search of PubMed for studies that evaluated the basic science, preparation and clinical application of platelet concentrates was performed. The search used terms, including platelet-rich plasma or PRP preparation, activation, use in the knee, cartilage, ligament, and meniscus. Studies found in the initial search and related studies were reviewed. Results. A comprehensive review of the literature supports the potential use of PRP both nonoperatively and intraoperatively, but highlights the absence of large clinical studies and the lack of standardization between method, product, and clinical efficacy. Conclusions and Relevance. In addition to the call for more randomized, controlled clinical studies to assess the clinical effect of PRP, at this point, it is necessary to investigate PRP product composition and eventually have the ability to tailor the therapeutic product for specific indications. PMID:26069674

Centralized Research Recruitment—Evolving a Local Clinical Research Recruitment Web Application to Better Meet User Needs

PubMed Central

Dwyer‐White, Molly; Doshi, Aalap; Hill, Mary; Pienta, Kenneth J.

2011-01-01

Abstract  Recruiting volunteers into clinical research remains a significant challenge for many clinical research study teams, thus the Michigan Institute for Clinical and Health Research (MICHR) at the University of Michigan developed UMClinicalStudies (http://www.UMClinicalStudies.org)—a Web application that links the community to a single gateway for clinical research. UMClinicalStudies (formerly named “Engage”) is an integral piece of MICHR’s efforts to increase clinical research participation in order to advance medical discoveries. Despite the initial success of the application, barriers to research participation remain, including the applications accessibility for potential research volunteers and study team members. In response, new initiatives were instigated to identify user needs, in order to broaden the ability to simultaneously assist researchers in recruitment activities, while also aiding potential volunteers in the exploration of and participation in clinical research opportunities. To do this, improvements to the interface and functionality were identified and implemented for both the public and the research audiences through extensive system analysis, and through the application of human computer interactivity processes, resulting in significant improvements in usability and ultimately research volunteerism, indicating that utilizing such technology is pivotal in reaching broader audiences for clinical trial participation. Clin Trans Sci 2011; Volume 4: 363–368 PMID:22029810

Strengthening the reliability and credibility of observational epidemiology studies by creating an Observational Studies Register.

PubMed

Swaen, Gerard M H; Carmichael, Neil; Doe, John

2011-05-01

To evaluate the need for the creation of a system in which observational epidemiology studies are registered; an Observational Studies Register (OSR). The current scientific process for observational epidemiology studies is described. Next, a parallel is made with the clinical trials area, where the creation of clinical trial registers has greatly restored and improved their credibility and reliability. Next, the advantages and disadvantages of an OSR are compared. The advantages of an OSR outweigh its disadvantages. The creation of an OSR, similar to the existing Clinical Trials Registers, will improve the assessment of publication bias and will provide an opportunity to compare the original study protocol with the results reported in the publication. Reliability, credibility, and transparency of observational epidemiology studies are strengthened by the creation of an OSR. We propose a structured, collaborative, and coordinated approach for observational epidemiology studies that can provide solutions for existing weaknesses and will strengthen credibility and reliability, similar to the approach currently used in clinical trials, where Clinical Trials Registers have played a key role in strengthening their scientific value. Copyright © 2011 Elsevier Inc. All rights reserved.

Exploring the environment of clinical baccalaureate nursing students' education in Iran; A qualitative descriptive study.

PubMed

Yousefy, Alireza; Yazdannik, Ahmad reza; Mohammadi, Sepideh

2015-12-01

Today's students are the nurses of tomorrow. They need appropriate clinical learning opportunities in order to shape their professional identity, attitudes and values. Despite undeniable progresses of nursing education in Iran, the quality of the clinical education in Iran is not favorable. There is a need to explore the environment of clinical baccalaureate nursing students' education for developing, maintaining and enhancing the quality of clinical program. This is a qualitative study and was conducted based on content analysis multimethod design. Data were collected by individual interviews, focus groups and direct observations. 54 nursing students and 8 clinical educators from the four geographically diverse universities in the Iran composed the study sample. A purposive sampling was used. Five themes were emerged from data analysis including; ambiguity in the nursing care role, routine-based nursing care, uncritical and dependent thinking climate, incompetency of clinical educators and patient education as important component of nursing. The findings of this study describe a clearer understanding of the real environment of the clinical education in Iran. All of themes that emerged from the study play an important role in student learning and nursing education. It is crucial to pay more attention to reconsider care concept as an operational component of nursing, maximize meaningful learning opportunities, reevaluate clinical instructor as role models and prepare effective operational plan to combine theoretical and evidence based knowledge with clinical practice. Copyright © 2015 Elsevier Ltd. All rights reserved.

Clinical trial participation. Viewpoints from racial/ethnic groups.

PubMed

Roberson, N L

1994-11-01

Racial/ethnic groups' participation in clinical trials is a relatively new area of research that warrants attention. Although racial/ethnic groups have been included in experimental studies since the 1940s, they were not included in significant numbers in clinical trials for cancer. Clinical trials play a dominant role in clinical oncology. Despite this state-of-the-art cancer treatment, however, there is mounting concern that this scientific progress is not being shared equitably by all segments of the U.S. population. There is underrepresentation of members of racial/ethnic groups in cancer clinical trials, which suggests that participation may be a critical issue. Unfortunately, little is known or documented about these groups' participation in clinical trials. This paper discusses racial/ethnic groups' views and opinions about clinical trial participation. Diagnostic research was conducted as a beginning phase to investigate this new area of research. African Americans, Hispanics, and Native Americans in three Buffalo, New York, communities were selected as study subjects. Data were collected via telephone surveys. Qualitative methods were employed for data analysis and reporting. Findings showed that study subjects knew little about cancer clinical trials and basically had no opportunity to participate. They believed that participation in clinical trials could be beneficial. In each of the three groups, however, there were cultural factors believed to influence participation. A primary concern was "mistrust of white people" and the feeling of being treated like "guinea pigs." Based on study findings, it was evident that recruitment for improving participation requires strategic planning that involves participants representative of the study population. To yield results, the plan should be tailored to the target group, presented as a credible study, designed to reflect trust in the medical care team, and implemented through a continuous educational process.

Research-active clinical nurses: against all odds.

PubMed

Siedlecki, Sandra L; Albert, Nancy M

2017-03-01

To develop a theoretical understanding of factors that impact decisions of clinical nurses to conduct a research study. Only a small percentage of all nurses are research-active and even fewer clinical nurses are research-active. Several researchers have explored barriers to research activity by clinical nurses, but few have examined why, in spite of all odds, some clinical nurses are research-active. As the purpose of this study was to develop a theoretical understanding of the research-active nurse, a grounded theory approach was used. The sample interviewed for this study consisted of registered nurses (n = 26) who worked in a hospital or ambulatory setting, had daily direct patient contact and had participated as principal investigator on at least one completed clinical nursing research study that was not in fulfilment of an educational requirement. The interviews were digitally recorded and analysed by two researchers using the constant comparative method. The findings from this study suggest that the conduct of research by clinical nurses was the direct result of a clinical trigger, characteristics and beliefs of the nurse about research and their role in generating knowledge, and the presence of support conditions, such as a research mentor. Clinical nurses can and do conduct research, in spite of constraints due to a lack of time, money and/or knowledge, if they have access to research mentors and are practising in a research-supportive environment. Nurses at the bedside are in a unique position to identify problems most in need of solutions. Findings from this study provide a foundation upon which to develop and test various programmes that seek to increase the number of clinical nurses who are research-active. © 2016 John Wiley & Sons Ltd.

Assessment of critical thinking: a Delphi study.

PubMed

Paul, Sheila A

2014-11-01

Nurse educators are responsible for preparing nurses who critically analyze patient information and provide meaningful interventions in today's complex health care system. By using the Delphi research method, this study, utilized the specialized and experiential knowledge of Certified Nurse Educators. This original Delphi research study asked Certified Nurse Educators how to assess the critical-thinking ability of nursing students in the clinical setting. The results showed that nurse educators need time, during the clinical experience, to accurately assess each individual nursing student. This study demonstrated the need for extended student clinical time, and a variety of clinical learning assessment tools. Copyright © 2014 Elsevier Ltd. All rights reserved.

Heated humidification improves clinical outcomes, compared to a heat and moisture exchanger in children with tracheostomies.

PubMed

McNamara, David G; Asher, M Innes; Rubin, Bruce K; Stewart, Alistair; Byrnes, Catherine A

2014-01-01

The upper airway humidifies and warms inspired gases before they reach the trachea, a process bypassed by the insertion of a tracheostomy, necessitating humidification of inspired gases. The optimal method of humidification is not known. We conducted a short-term 20-hour study and a long-term 10-week randomized crossover study comparing a heated humidifier (HH) to a heat and moisture exchanger (HME) in children with established tracheostomies. Subjects were assessed for clinical events, clinical examination findings, airway cytokine levels, and airway secretion viscoelasticity. For the short-term study, 15 children were recruited; for the long-term study, 14 children were recruited. Children using the HH had decreased respiratory examination score (P < .001) but no change in clinical events over the short term. There was a decrease in acute clinical events (P = .008) in the long-term study. No differences were found in airway secretion viscoelasticity results or cytokine levels in either study, but these sample numbers were limited. Over 20 hours use, HH, compared to HME, improved work of breathing. Over a longer 10 week treatment period HH resulted in decreased adverse clinical events.

The Use of Published Clinical Study Reports to Support U.S. Food and Drug Administration Approval of Imaging Agents.

PubMed

Rieves, Dwaine; Jacobs, Paula

2016-12-01

Pharmaceutical companies typically perform prospective, multicenter phase 3 clinical studies to support approval of a new imaging agent by the U.S. Food and Drug Administration (FDA). In uncommon situations, the FDA has approved imaging agents based solely, or in large part, on the clinical study experience described in published reports, including reports of exploratory (i.e., phase 1 or 2) studies performed at a single clinical site. We performed a survey of published reports to assess the potential of the reported information to support FDA approval of a commonly cited investigational imaging agent. Our survey revealed critical data limitations in most publications, all of which reported exploratory clinical studies. Here we summarize the precedent for FDA approval of imaging agents using effectiveness data from publications, FDA guidance, and our experience in reviewing publications. We also present a key-data checklist for investigators to consider in the design, conduct, and reporting of exploratory clinical studies for publication. We encourage editors and peer reviewers to consider requiring these key data when reviewing these reports for publication. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

An integrative model for in-silico clinical-genomics discovery science.

PubMed

Lussier, Yves A; Sarkar, Indra Nell; Cantor, Michael

2002-01-01

Human Genome discovery research has set the pace for Post-Genomic Discovery Research. While post-genomic fields focused at the molecular level are intensively pursued, little effort is being deployed in the later stages of molecular medicine discovery research, such as clinical-genomics. The objective of this study is to demonstrate the relevance and significance of integrating mainstream clinical informatics decision support systems to current bioinformatics genomic discovery science. This paper is a feasibility study of an original model enabling novel "in-silico" clinical-genomic discovery science and that demonstrates its feasibility. This model is designed to mediate queries among clinical and genomic knowledge bases with relevant bioinformatic analytic tools (e.g. gene clustering). Briefly, trait-disease-gene relationships were successfully illustrated using QMR, OMIM, SNOMED-RT, GeneCluster and TreeView. The analyses were visualized as two-dimensional dendrograms of clinical observations clustered around genes. To our knowledge, this is the first study using knowledge bases of clinical decision support systems for genomic discovery. Although this study is a proof of principle, it provides a framework for the development of clinical decision-support-system driven, high-throughput clinical-genomic technologies which could potentially unveil significant high-level functions of genes.

Service impact of a national clinical leadership development programme: findings from a qualitative study.

PubMed

Fealy, Gerard M; McNamara, Martin S; Casey, Mary; O'Connor, Tom; Patton, Declan; Doyle, Louise; Quinlan, Christina

2015-04-01

The study reported here was part of a larger study, which evaluated a national clinical leadership development programme with reference to resources, participant experiences, participant outcomes and service impact. The aim of the present study was to evaluate the programme's service impact. Clinical leadership development develops competencies that are expressed in context. The outcomes of clinical leadership development occur at individual, departmental and organisational levels. The methods used to evaluate the service impact were focus groups, group interviews and individual interviews. Seventy participants provided data in 18 separate qualitative data collection events. The data contained numerous accounts of service development activities, initiated by programme participants, which improved service and/or improved the culture of the work setting. Clinical leadership development programmes that incorporate a deliberate service impact element can result in identifiable positive service outcomes. The nuanced relationship between leader development and service development warrants further investigation. This study demonstrates that clinical leadership development can impact on service in distinct and identifiable ways. Clinical leadership development programmes should focus on the setting in which the leadership competencies will be demonstrated. © 2013 John Wiley & Sons Ltd.

Data quality assurance: an analysis of patient non-response.

PubMed

Derby, Dustin C; Haan, Andrea; Wood, Kurt

2011-01-01

Patient satisfaction is paramount to maintaining high clinical quality assurance. This study seeks to compare response rates, response bias, and the completeness of data between paper and electronic collection modes of a chiropractic patient satisfaction survey. A convenience sample of 206 patients presenting to a chiropractic college clinic were surveyed concerning satisfaction with their chiropractic care. Paper (in-clinic and postal) and electronic modes of survey administration were compared for response rates and non-response bias. The online data collection mode resulted in fewer non-responses and a higher response rate, and did not evince response bias when compared to paper modes. The postal paper mode predicted non-response rates over the in-clinic paper and online modalities and exhibited a gender bias. This current study was a single clinic study; future studies should consider multi-clinic data collections. Busy clinic operations and available staff resources restricted the ability to conduct a random sampling of patients or to invite all eligible patients, therefore limiting the generalizability of collected survey data. Results of this study will provide data to aid development of survey protocols that efficiently, account for available human resources, and are convenient for patients while allowing for the most complete and accurate data collection possible in an educational clinic setting. Understanding patient responses across survey modes is critical for the cultivation of quality business intelligence within college teaching clinic settings. This study bridges measurement evidence from three popular data collection modalities and offers support for higher levels of quality for web-based data collection.

Retrieval of diagnostic and treatment studies for clinical use through PubMed and PubMed's Clinical Queries filters.

PubMed

Lokker, Cynthia; Haynes, R Brian; Wilczynski, Nancy L; McKibbon, K Ann; Walter, Stephen D

2011-01-01

Clinical Queries filters were developed to improve the retrieval of high-quality studies in searches on clinical matters. The study objective was to determine the yield of relevant citations and physician satisfaction while searching for diagnostic and treatment studies using the Clinical Queries page of PubMed compared with searching PubMed without these filters. Forty practicing physicians, presented with standardized treatment and diagnosis questions and one question of their choosing, entered search terms which were processed in a random, blinded fashion through PubMed alone and PubMed Clinical Queries. Participants rated search retrievals for applicability to the question at hand and satisfaction. For treatment, the primary outcome of retrieval of relevant articles was not significantly different between the groups, but a higher proportion of articles from the Clinical Queries searches met methodologic criteria (p=0.049), and more articles were published in core internal medicine journals (p=0.056). For diagnosis, the filtered results returned more relevant articles (p=0.031) and fewer irrelevant articles (overall retrieval less, p=0.023); participants needed to screen fewer articles before arriving at the first relevant citation (p<0.05). Relevance was also influenced by content terms used by participants in searching. Participants varied greatly in their search performance. Clinical Queries filtered searches returned more high-quality studies, though the retrieval of relevant articles was only statistically different between the groups for diagnosis questions. Retrieving clinically important research studies from Medline is a challenging task for physicians. Methodological search filters can improve search retrieval.

A critical evaluation of the clinical evidence for pomegranate preparations in the prevention and treatment of cardiovascular diseases.

PubMed

Vlachojannis, Christian; Erne, Paul; Schoenenberger, Andreas W; Chrubasik-Hausmann, Sigrun

2015-04-01

This study attempts a critical evaluation of the clinical evidence behind the use of dietary pomegranate preparations in the prevention and treatment of cardiovascular diseases. A search of PubMed on August 10, 2014 identified 228 references, which yielded extractable data from 24 clinical studies of pomegranate preparations. Hand searching identified two further studies. The quality of the studies and evidence of effectiveness of pomegranate were assessed by an established set of conventional criteria. Overall, the study quality was poor. Even in the best studies, indications of benefit did not reach the conventional levels of statistical significance. The only study with a definitive design had a biochemical rather than a clinical endpoint: it showed the expected difference in blood concentrations of myeloperoxidase after a single dose of either pomegranate or placebo. Only 10 of the 26 studies provided HPLC data on the amounts of co-active ingredients in the preparations that were consumed by the subjects. If pomegranate has a role in the prevention and treatment of cardiovascular diseases, there is a pressing need for dose-finding and long-term confirmatory studies. The ultimate endpoint for definitive studies would be mortality, but reductions in blood pressure or demonstrable decreases in atherosclerotic plaques would be useful surrogates. Sample sizes for various assumptions are provided. Future studies need to prove the clinical benefit. Copyright © 2015 John Wiley & Sons, Ltd.

How can we improve clinical research in pneumonia?

PubMed

Ramirez, Julio A

2018-05-01

The primary challenges in the field of clinical research include a lack of support within existing infrastructure, insufficient number of clinical research training programs and a paucity of qualified mentors. Most medical centers offer infrastructure support for investigators working with industry sponsors or government-funded clinical trials, yet there are a significant amount of clinical studies performed in the field of pneumonia which are observational studies. For this type of research, which is frequently unfunded, support is usually lacking. In an attempt to optimize clinical research in pneumonia, at the University of Louisville, we developed a clinical research coordinating center (CRCC). The center manages clinical studies in the field of respiratory infections, with the primary focus being pneumonia. Other activities of the CRCC include the organization of an annual clinical research training course for physicians and other healthcare workers, and the facilitation of international research mentoring by a process of connecting new pneumonia investigators with established clinical investigators. To improve clinical research in pneumonia, institutions need to have the appropriate infrastructure in place to support investigators in all aspects of the clinical research process.

Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.

PubMed

Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo

2017-12-01

The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants <18 years old) conducted in South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.

[Design requirements for clinical trials on re-evaluation of safety and efficacy of post-marketed Chinese herbs].

PubMed

Xie, Yanming; Wei, Xu

2011-10-01

Re-evaluation of post-marketed based on pharmacoepidemiology is to study and collect clinical medicine safety in large population under practical applications for a long time. It is necessary to conduct re-evaluation of clinical effectiveness because of particularity of traditional Chinese medicine (TCM). Right before carrying out clinical trials on re-evaluation of post-marketed TCM, we should determine the objective of the study and progress it in the assessment mode of combination of disease and syndrome. Specical population, involving children and seniors who were excluded in pre-marketed clinical trial, were brought into drug monitoring. Sample size needs to comply with statistical requirement. We commonly use cohort study, case-control study, nested case-control, pragmatic randomized controlled trials.

Validation of Mismatch Negativity and P3a for Use in Multi-Site Studies of Schizophrenia: Characterization of Demographic, Clinical, Cognitive, and Functional Correlates in COGS-2

PubMed Central

Light, Gregory A.; Swerdlow, Neal R.; Thomas, Michael L.; Calkins, Monica E.; Green, Michael F.; Greenwood, Tiffany A.; Gur, Raquel E.; Gur, Ruben C.; Lazzeroni, Laura C.; Nuechterlein, Keith H.; Pela, Marlena; Radant, Allen D.; Seidman, Larry J.; Sharp, Richard F.; Siever, Larry J.; Silverman, Jeremy M.; Sprock, Joyce; Stone, William S.; Sugar, Catherine A.; Tsuang, Debby W.; Tsuang, Ming T.; Braff, David L.; Turetsky, Bruce I.

2014-01-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP data was obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. PMID:25449710

Validation of mismatch negativity and P3a for use in multi-site studies of schizophrenia: characterization of demographic, clinical, cognitive, and functional correlates in COGS-2.

PubMed

Light, Gregory A; Swerdlow, Neal R; Thomas, Michael L; Calkins, Monica E; Green, Michael F; Greenwood, Tiffany A; Gur, Raquel E; Gur, Ruben C; Lazzeroni, Laura C; Nuechterlein, Keith H; Pela, Marlena; Radant, Allen D; Seidman, Larry J; Sharp, Richard F; Siever, Larry J; Silverman, Jeremy M; Sprock, Joyce; Stone, William S; Sugar, Catherine A; Tsuang, Debby W; Tsuang, Ming T; Braff, David L; Turetsky, Bruce I

2015-04-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP recordings were obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. Published by Elsevier B.V.

Advances of human bone marrow-derived mesenchymal stem cells in the treatment of cartilage defects: a systematic review.

PubMed

Gopal, Kaliappan; Amirhamed, Haji Alizadeh; Kamarul, Tunku

2014-06-01

Mesenchymal stem cell (MSC)-based therapies represent a new option for treating damaged cartilage. However, the outcomes following its clinical application have seldom been previously compared. The present paper presents the systematic review of current literatures on MSC-based therapy for cartilage repair in clinical applications. Ovid, Scopus, PubMed, ISI Web of Knowledge and Google Scholar online databases were searched using several keywords, which include "cartilage" and "stem cells". Only studies using bone marrow-derived MSC (BM-MSC) to treat cartilage defects clinically were included in this review. The clinical outcomes were compared, and the quality of the tissue repair was analysed where possible. Of the 996 articles, only six (n = 6) clinical studies have described the use of BM-MSC in clinical applications. Two studies were cohort observational trials, three were case series, and one was a case report. In the two comparative trials, BM-MSCs produced superior repair to cartilage treatment without cells and have comparable outcomes to autologous chondrocyte implantation. The case series and case-control studies have demonstrated that use of BM-MSCs resulted in better short- to long-term clinical outcomes with minimal complications. In addition, histological analyses in two studies have resulted in good repair tissue formation at the damaged site, composed mainly of hyaline-like cartilage. Although results of the respective studies are highly indicative that BM-MSC-based therapy is superior, due to the differences in methods and selection criteria used, it was not possible to make direct comparison between the studies. In conclusion, published studies do suggest that BM-MSCs could provide superior cartilage repair. However, due to limited number of reports, more robust studies might be required before a definitive conclusion can be drawn.

Efficacy of curcumin for age-associated cognitive decline: a narrative review of preclinical and clinical studies.

PubMed

Sarker, Marjana Rahman; Franks, Susan F

2018-04-21

Processes such as aberrant redox signaling and chronic low-grade systemic inflammation have been reported to modulate age-associated pathologies such as cognitive impairment. Curcumin, the primary therapeutic component of the Indian spice, Turmeric (Curcuma longa), has long been known for its strong anti-inflammatory and antioxidant activity attributable to its unique molecular structure. Recently, an interest in this polyphenol as a cognitive therapeutic for the elderly has emerged. The purpose of this paper is to critically review preclinical and clinical studies that have evaluated the efficacy of curcumin in ameliorating and preventing age-associated cognitive decline and address the translational progress of preclinical to clinical efficacy. PubMed, semantic scholar, and Google scholar searches were used for preclinical studies; and clinicaltrials.gov , the Australian and New Zealand clinical trials registry, and PubMed search were used to select relevant completed clinical studies. Results from preclinical studies consistently demonstrate curcumin and its analogues to be efficacious for various aspects of cognitive impairment and processes that contribute to age-associated cognitive impairment. Results of published clinical studies, while mixed, continue to show promise for curcumin's use as a therapeutic for cognitive decline but overall remain inconclusive at this time. Both in vitro and in vivo studies have found that curcumin can significantly decrease oxidative stress, systemic inflammation, and obstruct pathways that activate transcription factors that augment these processes. Future clinical studies would benefit from including evaluation of peripheral and cerebrospinal fluid biomarkers of dementia and behavioral markers of cognitive decline, as well as targeting the appropriate population.

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review

PubMed Central

van den Ende, Cornelia H. M.; Houterman, Anne E. J.; Heemskerk, Charlotte P. M.; van Dulmen, Sandra; van den Bemt, Bart J. F.

2017-01-01

Objective This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. Methods A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Results Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Conclusion Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF. PMID:28991903

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review.

PubMed

van Heuckelum, Milou; van den Ende, Cornelia H M; Houterman, Anne E J; Heemskerk, Charlotte P M; van Dulmen, Sandra; van den Bemt, Bart J F

2017-01-01

This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF.

Participation in clinical trials among women living with HIV in Canada

PubMed Central

Hankins, C; Lapointe, N; Walmsley, S

1998-01-01

BACKGROUND: To describe participation in clinical trials among HIV-positive women enrolled since 1993 in the Canadian Women's HIV Study, a prospective open cohort study. METHODS: All HIV-positive women being followed at hospital-based or community-based clinics at 28 sites in 11 Canadian cities were eligible to participate in the Canadian Women's HIV Study. Baseline and follow-up information was collected for 413 women every 6 months by study nurses using standardized questionnaires. Data included sociodemographic variables, HIV exposure group, CD4 count, disease classification, use of antiretroviral therapies and participation in clinical trials. RESULTS: At study intake 15.0% (62/413) of the women had participated in a clinical trial; an additional 8.5% (35/413) participated during a median follow-up of 18 months. Multivariate analysis revealed that the following factors were independently associated with participation in a clinical trial: white race (adjusted odds ratio [OR] 3.38, p = 0.001), current use of antiretroviral therapy (adjusted OR 2.01, p = 0.008), completion of secondary school (adjusted OR 1.97, p = 0.024) and residence in the Prairies or Atlantic provinces (adjusted OR 1.98, p = 0.043). INTERPRETATION: Although the overall clinical trial participation rate of 23.5% was relatively high among HIV-positive women, injection drug users were underrepresented in this study population, and non-white women, women who did not complete high school and women not receiving antiretroviral therapy were less likely than white women, women of higher education and women receiving antiretroviral therapy to participate in clinical trials in Canada. Because of the importance of trial participants being representative of the population for which therapeutic agents are intended, HIV clinical trials must recruit women with lower literacy levels, non-white women, women not receiving antiretroviral therapy and women who are injection drug users to ensure generalizability of research findings. Further study is needed to assess factors that act as barriers and motivators to women's participation in HIV clinical trials. PMID:9861204

Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

PubMed

Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

2008-08-01

To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.

The Effect of Sodium Hypochlorite and Chlorhexidine as Irrigant Solutions for Root Canal Disinfection: A Systematic Review of Clinical Trials.

PubMed

Gonçalves, Lucio Souza; Rodrigues, Renata Costa Val; Andrade Junior, Carlos Vieira; Soares, Renata G; Vettore, Mario Vianna

2016-04-01

This systematic review aimed to compare the effectiveness of sodium hypochlorite and chlorhexidine for root canal disinfection during root canal therapy. A literature search for clinical trials was made on the PubMed (MEDLINE), Web of Knowledge, SCOPUS, and Science Direct databases and in the reference lists of the identified articles up to January 2015. Quality assessment of the selected studies was performed according to the Consolidated Standards of Reporting Trials statement. One clinical trial and 4 randomized clinical trials were selected from the 172 articles initially identified. There was heterogeneity in the laboratory methods used to assess the root canal disinfection as well as in the concentrations of the irrigants used. Therefore, meta-analysis was not performed. Two studies reported effective and similar reductions in bacterial levels for both irrigants. Sodium hypochlorite was more effective than chlorhexidine in reducing microorganisms in 1 study, and another reported opposite findings. Both root irrigants were ineffective in eliminating endotoxins from necrotic pulp root canals in 1 study. Trial design and information regarding randomization procedures were not clearly described in the clinical trials. No study compared laboratory results with clinical outcomes. The available evidence on this topic is scarce, and the findings of studies were not consistent. Additional randomized clinical trials using clinical outcomes to compare the use of sodium hypochlorite and chlorhexidine during root canal therapy are needed. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

The Brain Health Registry: An internet-based platform for recruitment, assessment, and longitudinal monitoring of participants for neuroscience studies.

PubMed

Weiner, Michael W; Nosheny, Rachel; Camacho, Monica; Truran-Sacrey, Diana; Mackin, R Scott; Flenniken, Derek; Ulbricht, Aaron; Insel, Philip; Finley, Shannon; Fockler, Juliet; Veitch, Dallas

2018-05-08

Recruitment, assessment, and longitudinal monitoring of participants for neuroscience studies and clinical trials limit the development of new treatments. Widespread Internet use allows data capture from participants in an unsupervised setting. The Brain Health Registry, a website and online registry, collects data from participants and their study partners. The Brain Health Registry obtains self and study partner report questionnaires and neuropsychological data, including the Cogstate Brief Battery, Lumos Labs Neurocognitive Performance Test, and MemTrax Memory Test. Participants provide informed consent before participation. Baseline and longitudinal data were obtained from nearly 57,000 and 28,000 participants, respectively. Over 18,800 participants were referred to, and nearly 1800 were enrolled in, clinical Alzheimer's disease and aging studies, including five observational studies and seven intervention trials. Online assessments of participants and study partners provide useful information at relatively low cost for neuroscience studies and clinical trials and may ultimately be used in routine clinical practice. Copyright © 2018 the Alzheimer's Association. All rights reserved.

Community vs. Clinic-Based Modular Treatment of Children with Early-Onset ODD or CD: A Clinical Trial with 3-Year Follow-Up

ERIC Educational Resources Information Center

Kolko, David J.; Dorn, Lorah D.; Bukstein, Oscar G.; Pardini, Dustin; Holden, Elizabeth A.; Hart, Jonathan

2009-01-01

This study examines the treatment outcomes of 139, 6-11 year-old, clinically referred boys and girls diagnosed with Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD) who were randomly assigned to a modular-based treatment protocol that was applied by research study clinicians either in the community (COMM) or a clinic office (CLINIC).…

[Patients' perspective and economic variables as objectives in clinical trials: added value to clinical parameters].

PubMed

Bovaira-García, M J; Soler-Company, E

2012-01-01

Patient-reported outcome (PRO) measures complement traditional biomedical outcome measures. The purpose of this study was to evaluate the use of PRO measures including health-related quality of life (HRQoL) questionnaires as a measurement of efficacy and the frequency of inclusion of economic variables related to direct and indirect costs in the design of clinical trials and phase IV observational studies. Moreover, for the trials quality score were measured, and if there were any relationship between the quality study design score and the PRO inclusion. Retrospective observational study of the clinical trials and phase IV observational studies approved by a Clinical Research Ethics Committee (2008-2010). We gathered data concerning general aspects including medical specialty, pathology, methodological quality based on Jadad scale (0-5), inclusion of PRO and economic variables. For clinical trials including HRQoL measurements, we analysed the type of questionnaire in use. Where there were no HRQoL measurements, we analysed if their inclusion would have been proper or not. A total of 70 protocols (59 CTs and 11 phase IV observational studies) were analysed; 37 (52.8%) included PRO measures, and 3 protocols (4.3%) used them as a primary endpoint. Data analysis by therapeutic area showed that PRO measures were most commonly studied in the fields of endocrinology, neurology, digestive diseases, and cardiology. The average quality score for the trials was 2.8. The trials with more PRO inclusion in their end points had a significantly higher quality score. Only 13 (22%) clinical trials and 2 (18.2%) phase IV observational studies included economic variables. The emergence of economic variables in clinical trials and phase IV observational studies evaluated was low, however, more than half of the revised protocols have included PRO measures, reflecting the importance of these parameters in the assessment of the effectiveness of drug treatments, although its use is still not systematic. Copyright © 2011 SECA. Published by Elsevier Espana. All rights reserved.

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study.

PubMed

Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

2014-06-04

To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Clinical study reports obtained from the EMA in 2011. Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the listings of adverse events for individual patients and narratives of adverse events can provide additional information, including original investigator reported adverse event terms, which can enable a more accurate estimate of harms. © Maund et al 2014.

Improving clinical trials in the critically ill.

PubMed

Angus, Derek C; Mira, Jean-Paul; Vincent, Jean-Louis

2010-02-01

To propose ways in which clinical trials in intensive care can be improved. An international roundtable conference was convened focused on improvement in three broad areas: translation of new knowledge from bench to bedside; design and conduct of clinical trials; and clinical trial infrastructure and environment. The roundtable recommendations were: improvement in clinical trials is a multistep process from better preclinical studies to better clinical trial methodology; new technologies should be used to improve models of critical illness; diseasomes and theragnostics will aid inpatient population selection and more appropriate targeting of interventions; broader study end points should include morbidity as well as mortality; more multicenter studies should be conducted by national and international networks or clinical trials groups; and better collaboration is needed with the industry. There was broad agreement among the roundtable participants regarding a number of explicit opportunities for the improvement of clinical trials in critical care.

Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder.

PubMed

Nierenberg, Andrew A; Sylvia, Louisa G; Leon, Andrew C; Reilly-Harrington, Noreen A; Shesler, Leah W; McElroy, Susan L; Friedman, Edward S; Thase, Michael E; Shelton, Richard C; Bowden, Charles L; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence A; Kocsis, James H; McInnis, Melvin G; Schoenfeld, David; Bobo, William V; Calabrese, Joseph R

2014-02-01

Classic and second-generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the 'real-world' advantages and disadvantages of these medications. We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This article outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments (APTs). The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score, and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT). The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus APT, across 10 sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. In all, 482 participants were randomized to the study, and 364 completed the study. The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants' ability to pay for study medications. We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second-generation antipsychotic with broad-spectrum activity in bipolar disorder, and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial.

Deciphering Sources of Variability in Clinical Pathology.

PubMed

Tripathi, Niraj K; Everds, Nancy E; Schultze, A Eric; Irizarry, Armando R; Hall, Robert L; Provencher, Anne; Aulbach, Adam

2017-01-01

The objectives of this session were to explore causes of variability in clinical pathology data due to preanalytical and analytical variables as well as study design and other procedures that occur in toxicity testing studies. The presenters highlighted challenges associated with such variability in differentiating test article-related effects from the effects of experimental procedures and its impact on overall data interpretation. These presentations focused on preanalytical and analytical variables and study design-related factors and their influence on clinical pathology data, and the importance of various factors that influence data interpretation including statistical analysis and reference intervals. Overall, these presentations touched upon potential effect of many variables on clinical pathology parameters, including animal physiology, sample collection process, specimen handling and analysis, study design, and some discussion points on how to manage those variables to ensure accurate interpretation of clinical pathology data in toxicity studies. This article is a brief synopsis of presentations given in a session entitled "Deciphering Sources of Variability in Clinical Pathology-It's Not Just about the Numbers" that occurred at the 35th Annual Symposium of the Society of Toxicologic Pathology in San Diego, California.

Advances in clinical NK cell studies: Donor selection, manufacturing and quality control

PubMed Central

Koehl, U.; Kalberer, C.; Spanholtz, J.; Lee, D. A.; Miller, J. S.; Cooley, S.; Lowdell, M.; Uharek, L.; Klingemann, H.; Curti, A.; Leung, W.; Alici, E.

2016-01-01

ABSTRACT Natural killer (NK) cells are increasingly used in clinical studies in order to treat patients with various malignancies. The following review summarizes platform lectures and 2013–2015 consortium meetings on manufacturing and clinical use of NK cells in Europe and United States. A broad overview of recent pre-clinical and clinical results in NK cell therapies is provided based on unstimulated, cytokine-activated, as well as genetically engineered NK cells using chimeric antigen receptors (CAR). Differences in donor selection, manufacturing and quality control of NK cells for cancer immunotherapies are described and basic recommendations are outlined for harmonization in future NK cell studies. PMID:27141397

Clinical Profile of Children and Adolescents Attending the Behavioural Paediatrics Unit OPD in a Tertiary Care Set up

ERIC Educational Resources Information Center

Jayaprakash, R.

2012-01-01

Background: There are limited studies on the clinical profile of children attending child guidance clinic under Paediatric background. Aims: To study clinical profile of Children & adolescents attending the Behavioural Paediatrics Unit (BPU) OPD under department of Paediatrics in a tertiary care set up. Methods: Monthly average turnover in the…

[Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

PubMed

Inagaki, Osamu

2016-04-01

Pharmaceutical companies recognize the importance of post-marketing studies because they are crucial in the generation of clinical evidences for the usage of new medicines. To generate clinical evidences, quality of post-marketing studies should be well controlled from view point of "ethical conduction" and "reliability of results". In addition, control of conflict of interest (COI) between researchers and industries is also indispensable and is requested for the transparency of the studies. Japan Pharmaceutical Manufacturers Association(JPMA)stresses its commitment to the progressof transparency in post-marketing studies.

A Clinical Evaluation of Cone Beam Computed Tomography

DTIC Science & Technology

2013-07-31

body of literature lacks in vivo studies comparing CBCT images with clinical findings. The purpose of this descriptive case series was to...All (18/18) bone measurements were underrepresented on CBCT images in this study . This case series also identified limitations in accuracy when... study was to compare pre-surgical CBCT images against the actual clinical presentation of the hard tissues. METHOD: Eleven patients requiring

Computational challenges and human factors influencing the design and use of clinical research participant eligibility pre-screening tools

PubMed Central

2012-01-01

Background Clinical trials are the primary mechanism for advancing clinical care and evidenced-based practice, yet challenges with the recruitment of participants for such trials are widely recognized as a major barrier to these types of studies. Data warehouses (DW) store large amounts of heterogenous clinical data that can be used to enhance recruitment practices, but multiple challenges exist when using a data warehouse for such activities, due to the manner of collection, management, integration, analysis, and dissemination of the data. A critical step in leveraging the DW for recruitment purposes is being able to match trial eligibility criteria to discrete and semi-structured data types in the data warehouse, though trial eligibility criteria tend to be written without concern for their computability. We present the multi-modal evaluation of a web-based tool that can be used for pre-screening patients for clinical trial eligibility and assess the ability of this tool to be practically used for clinical research pre-screening and recruitment. Methods The study used a validation study, usability testing, and a heuristic evaluation to evaluate and characterize the operational characteristics of the software as well as human factors affecting its use. Results Clinical trials from the Division of Cardiology and the Department of Family Medicine were used for this multi-modal evaluation, which included a validation study, usability study, and a heuristic evaluation. From the results of the validation study, the software demonstrated a positive predictive value (PPV) of 54.12% and 0.7%, respectively, and a negative predictive value (NPV) of 73.3% and 87.5%, respectively, for two types of clinical trials. Heuristic principles concerning error prevention and documentation were characterized as the major usability issues during the heuristic evaluation. Conclusions This software is intended to provide an initial list of eligible patients to a clinical study coordinators, which provides a starting point for further eligibility screening by the coordinator. Because this software has a high “rule in” ability, meaning that it is able to remove patients who are not eligible for the study, the use of an automated tool built to leverage an existing enterprise DW can be beneficial to determining eligibility and facilitating clinical trial recruitment through pre-screening. While the results of this study are promising, further refinement and study of this and related approaches to automated eligibility screening, including comparison to other approaches and stakeholder perceptions, are needed and future studies are planned to address these needs. PMID:22646313

Computational challenges and human factors influencing the design and use of clinical research participant eligibility pre-screening tools.

PubMed

Pressler, Taylor R; Yen, Po-Yin; Ding, Jing; Liu, Jianhua; Embi, Peter J; Payne, Philip R O

2012-05-30

Clinical trials are the primary mechanism for advancing clinical care and evidenced-based practice, yet challenges with the recruitment of participants for such trials are widely recognized as a major barrier to these types of studies. Data warehouses (DW) store large amounts of heterogenous clinical data that can be used to enhance recruitment practices, but multiple challenges exist when using a data warehouse for such activities, due to the manner of collection, management, integration, analysis, and dissemination of the data. A critical step in leveraging the DW for recruitment purposes is being able to match trial eligibility criteria to discrete and semi-structured data types in the data warehouse, though trial eligibility criteria tend to be written without concern for their computability. We present the multi-modal evaluation of a web-based tool that can be used for pre-screening patients for clinical trial eligibility and assess the ability of this tool to be practically used for clinical research pre-screening and recruitment. The study used a validation study, usability testing, and a heuristic evaluation to evaluate and characterize the operational characteristics of the software as well as human factors affecting its use. Clinical trials from the Division of Cardiology and the Department of Family Medicine were used for this multi-modal evaluation, which included a validation study, usability study, and a heuristic evaluation. From the results of the validation study, the software demonstrated a positive predictive value (PPV) of 54.12% and 0.7%, respectively, and a negative predictive value (NPV) of 73.3% and 87.5%, respectively, for two types of clinical trials. Heuristic principles concerning error prevention and documentation were characterized as the major usability issues during the heuristic evaluation. This software is intended to provide an initial list of eligible patients to a clinical study coordinators, which provides a starting point for further eligibility screening by the coordinator. Because this software has a high "rule in" ability, meaning that it is able to remove patients who are not eligible for the study, the use of an automated tool built to leverage an existing enterprise DW can be beneficial to determining eligibility and facilitating clinical trial recruitment through pre-screening. While the results of this study are promising, further refinement and study of this and related approaches to automated eligibility screening, including comparison to other approaches and stakeholder perceptions, are needed and future studies are planned to address these needs.

A systematic review of diagnostic criteria for psoriasis in adults and children: evidence from studies with a primary aim to develop or validate diagnostic criteria.

PubMed

Burden-Teh, E; Phillips, R C; Thomas, K S; Ratib, S; Grindlay, D; Murphy, R

2017-11-06

The diagnosis of psoriasis in adults and children is made clinically, for both patient management and the selection of participants in research. Diagnostic criteria provide a structure for clinical assessment, which in turn helps standardize patient recruitment into clinical trials and case definitions in observational studies. The aim of this systematic review was to identify and critically appraise the published studies to date that had a primary research aim to develop or validate diagnostic criteria for psoriasis. A search of Ovid MEDLINE and Ovid Embase was conducted in October 2016. The primary objective was to record the sensitivity and specificity of diagnostic criteria for psoriasis. Secondary objectives included diagnostic recommendations, applicability to children and study characteristics. Diagnostic accuracy studies were critically appraised for risk of bias using the QUADAS-2 tool. Twenty-three studies met the inclusion criteria. None detailed clinical examination-based diagnostic criteria. The included criteria varied from genetic and molecular diagnostic models to skin imaging, histopathology, and questionnaire-based, computer-aided and traditional Chinese medicine criteria. High sensitivity and specificity (> 90%) were reported in many studies. However, the study authors often did not specify how the criteria would be used clinically or in research. This review identified studies with varying risk of bias, and due to each study developing separate criteria meta-analysis was not possible. Clinical examination-based diagnostic criteria are currently lacking for psoriasis. Future research could follow an international collaborative approach and employ study designs allowing high-quality diagnostic accuracy testing. Existing and newly developed criteria require validation. © 2017 British Association of Dermatologists.

Cognitive Fusion Questionnaire-Body Image: Psychometric Properties and Its Incremental Power in the Prediction of Binge Eating Severity.

PubMed

Lucena-Santos, Paola; Trindade, Inês A; Oliveira, Margareth; Pinto-Gouveia, José

2017-05-19

Given the clinical usefulness of the CFQ-BI (Cognitive Fusion Questionnaire-Body Image; the only existing measure to assess the body-image-related cognitive fusion), the present study aimed to confirm its one-factor structure, to verify its measurement invariance between clinical and non-clinical samples, to analyze its internal consistency and sensitivity to detect differences between samples, as well as to explore the incremental and convergent validities of the CFQ-BI scores in Brazilian samples.  This was a cross-sectional study, which was conducted in clinical (women with overweight or obesity in treatment for weight loss) and non-clinical samples (women from the general population). The one-factor structure was confirmed showing factorial measurement invariance across clinical and non-clinical samples. The CFQ-BI scores presented an excellent internal consistency, were able to discriminate clinical and non-clinical samples, and were positively associated with binge eating severity, general cognitive fusion, and psychological inflexibility. Furthermore, body-image-related cognitive fusion scores (CFQ-BI) presented incremental validity over a general measure of cognitive fusion in the prediction of binge eating symptoms. This study demonstrated that CFQ-BI is a short scale with reliable and robust scores in Brazilian samples, presenting incremental and convergent validities, measurement invariance, and sensitivity to detect differences between clinical and non-clinical groups of women, enabling comparative studies between them.

Intentional Modelling: A Process for Clinical Leadership Development in Mental Health Nursing.

PubMed

Ennis, Gary; Happell, Brenda; Reid-Searl, Kerry

2016-05-01

Clinical leadership is becoming more relevant for nurses, as the positive impact that it can have on the quality of care and outcomes for consumers is better understood and more clearly articulated in the literature. As clinical leadership continues to become more relevant, the need to gain an understanding of how clinical leaders in nursing develop will become increasingly important. While the attributes associated with effective clinical leadership are recognized in current literature there remains a paucity of research on how clinical leaders develop these attributes. This study utilized a grounded theory methodology to generate new insights into the experiences of peer identified clinical leaders in mental health nursing and the process of developing clinical leadership skills. Participants in this study were nurses working in a mental health setting who were identified as clinical leaders by their peers as opposed to identifying them by their role or organizational position. A process of intentional modeling emerged as the substantive theory identified in this study. Intentional modeling was described by participants in this study as a process that enabled them to purposefully identify models that assisted them in developing the characteristics of effective clinical leaders as well as allowing them to model these characteristics to others. Reflection on practice is an important contributor to intentional modelling. Intentional modelling could be developed as a framework for promoting knowledge and skill development in the area of clinical leadership.

Information and Communication Technologies for the Dissemination of Clinical Practice Guidelines to Health Professionals: A Systematic Review.

PubMed

De Angelis, Gino; Davies, Barbara; King, Judy; McEwan, Jessica; Cavallo, Sabrina; Loew, Laurianne; Wells, George A; Brosseau, Lucie

2016-11-30

The transfer of research knowledge into clinical practice can be a continuous challenge for researchers. Information and communication technologies, such as websites and email, have emerged as popular tools for the dissemination of evidence to health professionals. The objective of this systematic review was to identify research on health professionals' perceived usability and practice behavior change of information and communication technologies for the dissemination of clinical practice guidelines. We used a systematic approach to retrieve and extract data about relevant studies. We identified 2248 citations, of which 21 studies met criteria for inclusion; 20 studies were randomized controlled trials, and 1 was a controlled clinical trial. The following information and communication technologies were evaluated: websites (5 studies), computer software (3 studies), Web-based workshops (2 studies), computerized decision support systems (2 studies), electronic educational game (1 study), email (2 studies), and multifaceted interventions that consisted of at least one information and communication technology component (6 studies). Website studies demonstrated significant improvements in perceived usefulness and perceived ease of use, but not for knowledge, reducing barriers, and intention to use clinical practice guidelines. Computer software studies demonstrated significant improvements in perceived usefulness, but not for knowledge and skills. Web-based workshop and email studies demonstrated significant improvements in knowledge, perceived usefulness, and skills. An electronic educational game intervention demonstrated a significant improvement from baseline in knowledge after 12 and 24 weeks. Computerized decision support system studies demonstrated variable findings for improvement in skills. Multifaceted interventions demonstrated significant improvements in beliefs about capabilities, perceived usefulness, and intention to use clinical practice guidelines, but variable findings for improvements in skills. Most multifaceted studies demonstrated significant improvements in knowledge. The findings suggest that health professionals' perceived usability and practice behavior change vary by type of information and communication technology. Heterogeneity and the paucity of properly conducted studies did not allow for a clear comparison between studies and a conclusion on the effectiveness of information and communication technologies as a knowledge translation strategy for the dissemination of clinical practice guidelines. ©Gino De Angelis, Barbara Davies, Judy King, Jessica McEwan, Sabrina Cavallo, Laurianne Loew, George A Wells, Lucie Brosseau. Originally published in JMIR Medical Education (http://mededu.jmir.org), 30.11.2016.

Understanding data requirements of retrospective studies.

PubMed

Shenvi, Edna C; Meeker, Daniella; Boxwala, Aziz A

2015-01-01

Usage of data from electronic health records (EHRs) in clinical research is increasing, but there is little empirical knowledge of the data needed to support multiple types of research these sources support. This study seeks to characterize the types and patterns of data usage from EHRs for clinical research. We analyzed the data requirements of over 100 retrospective studies by mapping the selection criteria and study variables to data elements of two standard data dictionaries, one from the healthcare domain and the other from the clinical research domain. We also contacted study authors to validate our results. The majority of variables mapped to one or to both of the two dictionaries. Studies used an average of 4.46 (range 1-12) data element types in the selection criteria and 6.44 (range 1-15) in the study variables. The most frequently used items (e.g., procedure, condition, medication) are often available in coded form in EHRs. Study criteria were frequently complex, with 49 of 104 studies involving relationships between data elements and 22 of the studies using aggregate operations for data variables. Author responses supported these findings. The high proportion of mapped data elements demonstrates the significant potential for clinical data warehousing to facilitate clinical research. Unmapped data elements illustrate the difficulty in developing a complete data dictionary. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Challenges in evaluating clinical governance systems in iran: a qualitative study.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-04-01

In spite of the pivotal role of clinical governance in enhancing quality of services provided by hospitals across the country, a scientific framework with specific criteria for evaluating hospitals has not been developed so far. This study was conducted with the aim to identify the challenges involved in evaluating systems of clinical governance in Iran. For the purposes of this qualitative study, 15 semi-structured interviews with experts in the field were conducted in 2011 and the data were analyzed using framework analysis method. Five major challenges in evaluating clinical governance include managing human resources, improving clinical quality, managing development, organizing clinical governance, and providing patient-oriented healthcare system. Healthcare system in Iran requires a clinical governance program which has a patient-oriented approach in philosophy, operation, and effectiveness in order to meet the challenges ahead.

Methodological considerations in the design and implementation of clinical trials.

PubMed

Cirrincione, Constance T; Lavoie Smith, Ellen M; Pang, Herbert

2014-02-01

To review study design issues related to clinical trials led by oncology nurses, with special attention to those conducted within the cooperative group setting; to emphasize the importance of the statistician's role in the process of clinical trials. Studies available at clinicaltrials.gov using experimental designs that have been published in peer-reviewed journals; cooperative group trials are highlighted. The clinical trial is a primary means to test intervention efficacy. A properly designed and powered study with clear and measurable objectives is as important as the intervention itself. Collaboration among the study team, including the statistician, is central in developing and conducting appropriately designed studies. For optimal results, collaboration is an ongoing process that should begin early on. Copyright © 2014 Elsevier Inc. All rights reserved.

The Preservation of Cued Recall in the Acute Mentally Fatigued State: A Randomised Crossover Study.

PubMed

Flindall, Ian Richard; Leff, Daniel Richard; Pucks, Neysan; Sugden, Colin; Darzi, Ara

2016-01-01

The objective of this study is to investigate the impact of acute mental fatigue on the recall of clinical information in the non-sleep-deprived state. Acute mental fatigue in the non-sleep-deprived subject is rarely studied in the medical workforce. Patient handover has been highlighted as an area of high risk especially in fatigued subjects. This study evaluates the deterioration in recall of clinical information over 2 h with cognitively demanding work in non-sleep-deprived subjects. A randomised crossover study involving twenty medical students assessed free (presentation) and cued (MCQ) recall of clinical case histories at 0 and 2 h under low and high cognitive load using the N-Back task. Acute mental fatigue was assessed through the Visual Analogue Scale, Stanford Scale and NASA-TLX Mental Workload Rating Scale. Free recall is significantly impaired by increased cognitive load (p < 0.05) with subjects demonstrating perceived mental fatigue during the high cognitive load assessment. There was no significant difference in the amount of information retrieved by cued recall under high and low cognitive load conditions (p = 1). This study demonstrates the loss of clinical information over a short time period involving a mentally fatiguing, high cognitive load task. Free recall for the handover of clinical information is unreliable. Memory cues maintain recall of clinical information. This study provides evidence towards the requirement for standardisation of a structured patient handover. The use of memory cues (involving recognition memory and cued recall methodology) would be beneficial in a handover checklist to aid recall of clinical information and supports evidence for their adoption into clinical practice.

Bringing antiretroviral therapy (ART) closer to the end-user through mobile clinics and home-based ART: systematic review shows more evidence on the effectiveness and cost effectiveness is needed.

PubMed

Mdege, Noreen Dadirai; Chindove, Stanley

2014-01-01

Home-based antiretroviral therapy (ART) and ART through mobile clinics can potentially increase access to ART for large numbers of people, including hard-to-reach populations. We reviewed literature on the effectiveness and cost implications of the home-based ART and mobile clinic ART models. We searched Medline, Embase, PsycInfo, CINAHL, Cochrane Library, Web of Knowledge and Current Controlled Trials Register for articles published up to March 2012. We included non-randomised and randomised controlled clinical trials that recruited HIV/AIDS positive adults with or without prior exposure to ART. Six studies were included in the review, with only four effectiveness studies (all evaluating home-based ART and none for mobile clinic ART) and four studies reporting on the cost implications. The evidence suggests home-based ART is as effective as health facility-based ART, including on clinical outcomes, viral load and CD4+ count. However, three of these studies were very small. Studies suggest health facility-based ART is the most cost-effective, followed by mobile-clinic ART, with home-based ART being the least cost-effective. Evidence on the effectiveness and cost implications of mobile clinic and home-based ART is currently limited. Although the few available studies suggest home-based ART can potentially be as effective as health facility-based ART, there is need for more research before robust conclusions can be made. Results from the few available studies also suggest that health facility-based ART is the most cost-effective. Copyright © 2013 John Wiley & Sons, Ltd.

The contribution of traditional healers' clinics to public health care system in Addis Ababa, Ethiopia: a cross-sectional study

PubMed Central

2011-01-01

Background Ethiopian people have been using traditional medicine since time immemorial with 80% of its population dependent on traditional medicines. However, the documentation of traditional healers' clinics contribution to modern public health system in cosmopolitan cities is scanty. Studies conducted so far are limited and focused on the perceptions and practices of modern and traditional health practitioners about traditional medicine. Thus, a cross sectional study was conducted from February to May 2010 to assess the contribution of traditional healers' clinics to public health care system in Addis Ababa. Materials and methods Ten traditional healers who were willing to participate in the study and 306 patients who were visiting these traditional healers' clinics were interviewed using two types of semi-structured questionnaires. Data were summarized using percentages, tables and bar chart. Results The diseases mostly treated by traditional healers were wound, inflammation, herpes zoster, hemorrhoids, fracture, paralysis, back-pain, liver diseases, cancer and eczema. This study showed that traditional healers' clinics considerably contribute to public health care in Addis Ababa. Fifty two percent of patients reported that traditional healers' clinics were their first choice when they faced health problems. The reasons for visiting these clinics were 175 (57.2%) efficacy, 109 (35.6%) dissatisfaction with modern medicine, 10 (3.3%) dissatisfaction with modern medicine and efficacy, 6 (2.0%) cost and 6 (2.0%) dissatisfaction and cost. Females (55.2%), young age (20-40 years, 65.0%), never married (56.9%), orthodox (73.9%), Amhara (52.3%), educational status above grade 12 (34.6%) and government employees (29.4%) were frequent visitors. Healers reported that there was no form of cooperation with modern health professionals. The reasons were lack of motivation to collaborate and communicate with modern health service workers. Family based apprenticeship was the sources of knowledge for majority of the healers. Conclusions The study conducted showed that for the majority of patients interviewed traditional healers' clinics were one of the options to solve their health problems that indicated the considerable contribution of these clinics to the public health care system in Addis Ababa. Nevertheless, in this study the contribution of traditional healers' clinics to the public health system would have been better shown if individuals who are not users of the traditional healers' clinics were included in the interview. However, the study might be useful as a base line data for future evaluation of the significance of traditional healers' clinics for public health system and the services rendered in these clinics. PMID:22132758

The contribution of traditional healers' clinics to public health care system in Addis Ababa, Ethiopia: a cross-sectional study.

PubMed

Birhan, Wubet; Giday, Mirutse; Teklehaymanot, Tilahun

2011-12-02

Ethiopian people have been using traditional medicine since time immemorial with 80% of its population dependent on traditional medicines. However, the documentation of traditional healers' clinics contribution to modern public health system in cosmopolitan cities is scanty. Studies conducted so far are limited and focused on the perceptions and practices of modern and traditional health practitioners about traditional medicine. Thus, a cross sectional study was conducted from February to May 2010 to assess the contribution of traditional healers' clinics to public health care system in Addis Ababa. Ten traditional healers who were willing to participate in the study and 306 patients who were visiting these traditional healers' clinics were interviewed using two types of semi-structured questionnaires. Data were summarized using percentages, tables and bar chart. The diseases mostly treated by traditional healers were wound, inflammation, herpes zoster, hemorrhoids, fracture, paralysis, back-pain, liver diseases, cancer and eczema. This study showed that traditional healers' clinics considerably contribute to public health care in Addis Ababa. Fifty two percent of patients reported that traditional healers' clinics were their first choice when they faced health problems. The reasons for visiting these clinics were 175 (57.2%) efficacy, 109 (35.6%) dissatisfaction with modern medicine, 10 (3.3%) dissatisfaction with modern medicine and efficacy, 6 (2.0%) cost and 6 (2.0%) dissatisfaction and cost. Females (55.2%), young age (20-40 years, 65.0%), never married (56.9%), orthodox (73.9%), Amhara (52.3%), educational status above grade 12 (34.6%) and government employees (29.4%) were frequent visitors. Healers reported that there was no form of cooperation with modern health professionals. The reasons were lack of motivation to collaborate and communicate with modern health service workers. Family based apprenticeship was the sources of knowledge for majority of the healers. The study conducted showed that for the majority of patients interviewed traditional healers' clinics were one of the options to solve their health problems that indicated the considerable contribution of these clinics to the public health care system in Addis Ababa. Nevertheless, in this study the contribution of traditional healers' clinics to the public health system would have been better shown if individuals who are not users of the traditional healers' clinics were included in the interview. However, the study might be useful as a base line data for future evaluation of the significance of traditional healers' clinics for public health system and the services rendered in these clinics.

Methodology in diagnostic laboratory test research in clinical chemistry and clinical chemistry and laboratory medicine.

PubMed

Lumbreras-Lacarra, Blanca; Ramos-Rincón, José Manuel; Hernández-Aguado, Ildefonso

2004-03-01

The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests. We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently. Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine. The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals. The methodologic aspects that most need improvement are those linked to the clinical information of the populations studied. Editorial actions aimed to increase the quality of reporting of diagnostic studies could have a relevant positive effect, as shown by the improvement observed in Clinical Chemistry.

Mothering: an unacknowledged aspect of undergraduate clinical teachers' work in nursing.

PubMed

McKenna, Lisa; Wellard, Sally

2009-05-01

Clinical education is an important component of undergraduate nurse education, in which clinical teachers facilitate students' application of theoretical classroom knowledge into the clinical practice setting. Mothering as part of clinical teachers' work was a major finding from a larger study exploring clinical teaching work to identify what shaped their work and barriers to their work in clinical settings. The study used semi-structured interviews, informed by the work of Foucault. Maternal discourses emerged as a predominant one as participants presented their relationships with students describing examples of nurturing, protecting, supporting, guiding and providing discipline. The unexpected finding contradicted the dominant view of students as adult learners, and potentially positions them as dependent in their learning in clinical environments. Exploration of this discourse in the context of the study forms the basis of this paper. It is argued that the overall impact of maternal discourses on clinical teaching and learning is unclear but warrants more detailed investigation.

Prevalence of common mental disorders among Dutch medical students and related use and need of mental health care: a cross-sectional study.

PubMed

Gaspersz, Roxanne; Frings-Dresen, Monique H W; Sluiter, Judith K

2012-02-15

The purpose of the study was to assess common mental disorders and the related use and need for mental health care among clinically not yet active and clinically active medical students. All medical students (n=2266) at one Dutch medical university were approached. Students from study years 1-4 were defined as clinically not yet active and students from study years 5 and 6 as clinically active. An electronic survey was used to detect common mental disorders depression (BSI-DEP), anxiety (BSI-ANG), stress (4DSQ) and post-traumatic stress disorder (IES). The use of mental health services in the past 3 months and the need for mental health services were asked for. The prevalence of common mental disorders, the use and need for mental health services and differences between groups were calculated. The response rate was 52%: 814 clinically not yet active and 316 clinically active students. The prevalence of common mental disorders among clinically not yet active and clinically active students was 54% and 48%, respectively. The use of mental health services was 14% in clinically not yet active and 12% in clinically active students with common mental disorders (n.s.). The need for mental health services by clinically not yet active and clinically active students was 52% and 46%, respectively (n.s.). The prevalence of probable common mental disorders are higher among clinically not yet active than among clinically active students. The need of mental health services exceeds use, but is the same in the two groups of students.

Accuracy of clinical tests in the diagnosis of anterior cruciate ligament injury: a systematic review

PubMed Central

2014-01-01

Background Numerous clinical tests are used in the diagnosis of anterior cruciate ligament (ACL) injury but their accuracy is unclear. The purpose of this study is to evaluate the diagnostic accuracy of clinical tests for the diagnosis of ACL injury. Methods Study Design: Systematic review. The review protocol was registered through PROSPERO (CRD42012002069). Electronic databases (PubMed, MEDLINE, EMBASE, CINAHL) were searched up to 19th of June 2013 to identify diagnostic studies comparing the accuracy of clinical tests for ACL injury to an acceptable reference standard (arthroscopy, arthrotomy, or MRI). Risk of bias was appraised using the QUADAS-2 checklist. Index test accuracy was evaluated using a descriptive analysis of paired likelihood ratios and displayed as forest plots. Results A total of 285 full-text articles were assessed for eligibility, from which 14 studies were included in this review. Included studies were deemed to be clinically and statistically heterogeneous, so a meta-analysis was not performed. Nine clinical tests from the history (popping sound at time of injury, giving way, effusion, pain, ability to continue activity) and four from physical examination (anterior draw test, Lachman’s test, prone Lachman’s test and pivot shift test) were investigated for diagnostic accuracy. Inspection of positive and negative likelihood ratios indicated that none of the individual tests provide useful diagnostic information in a clinical setting. Most studies were at risk of bias and reported imprecise estimates of diagnostic accuracy. Conclusion Despite being widely used and accepted in clinical practice, the results of individual history items or physical tests do not meaningfully change the probability of ACL injury. In contrast combinations of tests have higher diagnostic accuracy; however the most accurate combination of clinical tests remains an area for future research. Clinical relevance Clinicians should be aware of the limitations associated with the use of clinical tests for diagnosis of ACL injury. PMID:25187877

Predictors of study completion and withdrawal in a randomized clinical trial of a pediatric diabetes adherence intervention.

PubMed

Driscoll, Kimberly A; Killian, Michael; Johnson, Suzanne Bennett; Silverstein, Janet H; Deeb, Larry C

2009-05-01

Loss of participants in randomized clinical trials threatens the validity of study findings. The purpose of this study was to determine pre-randomization predictors of study completion status throughout the course of a randomized clinical trial involving young children with type 1 diabetes and their primary caregivers. An intervention to improve adherence to the diabetes treatment regimen was delivered as part of the child's regular 3-month diabetes clinic visit. The study protocol involved 7 clinic visits across 18 months for the Immediate Treatment group and 9 clinic visits across 24 months for the Delayed Treatment group. Among those who completed the study and regardless of treatment group, participants were categorized into two groups: On-Time Completers (n=41) and Late Completers (n=39). Demographic, disease, and psychosocial characteristics of children and their primary caregivers measured prior to study randomization were tested for their association with the participants' completion status (i.e., On-Time Completers, Late Completers, or Withdrawals). Of the 108 participants, 28 (25.9%) withdrew and 80 (74.1%) completed the study. On-Time Completers (i.e., study completed within 4 months of expected date) were more likely to have private insurance and primary caregivers with some college education. Late Completers (i.e., study completion took longer than 4 months) were more likely to be boys and to have primary caregivers who reported mild to moderate levels of depression. Children who subsequently withdrew from the study reported poorer diabetes-related quality of life and poorer school-related quality of life at study inception and were more likely to have primary caregivers who did not work outside the home. Pre-randomization screening of participants on both demographic and psychological variables may help identify those at greatest risk for study withdrawal or poor study protocol adherence, permitting the investigators to develop retention strategies aimed at this high-risk group.

Recommendations for Planning Pilot Studies in Clinical and Translational Research

PubMed Central

Moore, Charity G.; Carter, Rickey E.; Nietert, Paul J.; Stewart, Paul W.

2011-01-01

Abstract  Advances in clinical and translation science are facilitated by building on prior knowledge gained through experimentation and observation. In the context of drug development, preclinical studies are followed by a progression of phase I through phase IV clinical trials. At each step, the study design and statistical strategies are framed around research questions that are prerequisites for the next phase. In other types of biomedical research, pilot studies are used for gathering preliminary support for the next research step. However, the phrase “pilot study” is liberally applied to projects with little or no funding, characteristic of studies with poorly developed research proposals, and usually conducted with no detailed thought of the subsequent study. In this article, we present a rigorous definition of a pilot study, offer recommendations for the design, analysis and sample size justification of pilot studies in clinical and translational research, and emphasize the important role that well‐designed pilot studies play in the advancement of science and scientific careers. Clin Trans Sci 2011; Volume 4: 332–337 PMID:22029804

77 FR 28890 - Center for Scientific Review; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-16

...: Oncology 2--Translational Clinical Integrated Review Group; Clinical Oncology Study Section. Date: June 11..., (301) 435-0682, [email protected] . Name of Committee: Oncology 1-Basic Translational Integrated... Committee: Oncology 2--Translational Clinical Integrated Review Group; Developmental Therapeutics Study...

Patient perspectives on physician conflict of interest in industry-sponsored clinical trials for multiple sclerosis therapeutics.

PubMed

Solomon, Andrew J; Klein, Eran P; Corboy, John R; Bernat, James L

2015-10-01

Pharmaceutical industry financial support of physicians, physician practices, and academic departments involved in multicenter industry-sponsored clinical trials of novel therapeutic agents is a relatively new and infrequently acknowledged source of potential physician conflict of interest. Detailed disclosure of these relationships to study participants is not uniformly a part of informed consent and documentation practices. To understand attitudes of patients with multiple sclerosis concerning disclosure of potential physician-industry conflicts of interest created by clinical trials and how such disclosures may influence study participation An anonymous online instrument was developed. 597 people with multiple sclerosis participated in the study. The study found that detailed disclosure of conflicts of interest is important to potential participants in industry-sponsored clinical trials for multiple sclerosis therapies and that the presence of these conflicts of interest may influence patients' decisions to participate in these studies. Findings from this study support a call for uniform guidelines regarding disclosure of physician-industry relationships to prospective research participants for industry-sponsored clinical trials. © The Author(s), 2015.

Approaches using molecular imaging technology - use of PET in clinical microdose studies§

PubMed Central

Wagner, Claudia C; Langer, Oliver

2013-01-01

Positron emission tomography (PET) imaging uses minute amounts of radiolabeled drug tracers and thereby meets the criteria for clinical microdose studies. The advantage of PET, when compared to other analytical methods used in microdose studies, is that the pharmacokinetics (PK) of a drug can be determined in the tissue targeted for drug treatment. PET microdosing already offers interesting applications in clinical oncology and in the development of central nervous system pharmaceuticals and is extending its range of application to many other fields of pharmaceutical medicine. Although requirements for preclinical safety testing for microdose studies have been cut down by regulatory authorities, radiopharmaceuticals increasingly need to be produced under good manufacturing practice (GMP) conditions, which increases the costs of PET microdosing studies. Further challenges in PET microdosing include combining PET with other ultrasensitive analytical methods, such as accelerator mass spectrometry (AMS), to gain plasma PK data of drugs, beyond the short PET examination periods. Finally, conducting clinical PET studies with radiolabeled drugs both at micro- and therapeutic doses is encouraged to answer the question of dose linearity in clinical microdosing. PMID:20887762

Herbal medicine for the management of polycystic ovary syndrome (PCOS) and associated oligo/amenorrhoea and hyperandrogenism; a review of the laboratory evidence for effects with corroborative clinical findings.

PubMed

Arentz, Susan; Abbott, Jason Anthony; Smith, Caroline Anne; Bensoussan, Alan

2014-12-18

Polycystic ovary syndrome (PCOS) is a prevalent, complex endocrine disorder characterised by polycystic ovaries, chronic anovulation and hyperandrogenism leading to symptoms of irregular menstrual cycles, hirsutism, acne and infertility. Evidence based medical management emphasises a multidisciplinary approach for PCOS, as conventional pharmaceutical treatment addresses single symptoms, may be contra-indicated, is often associated with side effects and not effective in some cases. In addition women with PCOS have expressed a strong desire for alternative treatments. This review examines the reproductive endocrine effects in PCOS for an alternative treatment, herbal medicine. The aim of this review was to identify consistent evidence from both pre-clinical and clinical research, to add to the evidence base for herbal medicine in PCOS (and associated oligo/amenorrhoea and hyperandrogenism) and to inform herbal selection in the provision clinical care for these common conditions. We undertook two searches of the scientific literature. The first search sought pre-clinical studies which explained the reproductive endocrine effects of whole herbal extracts in oligo/amenorrhoea, hyperandrogenism and PCOS. Herbal medicines from the first search informed key words for the second search. The second search sought clinical studies, which corroborated laboratory findings. Subjects included women with PCOS, menstrual irregularities and hyperandrogenism. A total of 33 studies were included in this review. Eighteen pre-clinical studies reported mechanisms of effect and fifteen clinical studies corroborated pre-clinical findings, including eight randomised controlled trials, and 762 women with menstrual irregularities, hyperandrogenism and/or PCOS. Interventions included herbal extracts of Vitex agnus-castus, Cimicifuga racemosa, Tribulus terrestris, Glycyrrhiza spp., Paeonia lactiflora and Cinnamomum cassia. Endocrine outcomes included reduced luteinising hormone (LH), prolactin, fasting insulin and testosterone. There was evidence for the regulation of ovulation, improved metabolic hormone profile and improved fertility outcomes in PCOS. There was evidence for an equivalent effect of two herbal medicines and the pharmaceutical agents bromocriptine (and Vitex agnus-castus) and clomiphene citrate (and Cimicifuga racemosa). There was less robust evidence for the complementary combination of spirinolactone and Glycyrrhiza spp. for hyperandrogenism. Preclinical and clinical studies provide evidence that six herbal medicines may have beneficial effects for women with oligo/amenorrhea, hyperandrogenism and PCOS. However the quantity of pre-clinical data was limited, and the quality of clinical evidence was variable. Further pre-clinical studies are needed to explain the effects of herbal medicines not included in this review with current clinical evidence but an absence of pre-clinical data.

Socio-demographic and clinical profiles of paranoid and nonparanoid schizophrenia: a prospective, multicenter study in China.

PubMed

Xiang, Yu-Tao; Wang, Chuan-Yue; Chiu, Helen F K; Weng, Yong-Zhen; Bo, Qi-Jing; Chan, Sandra S M; Lee, Edwin H M; Ungvari, Gabor S

2011-07-01

This study aimed to explore the socio-demographic and clinical characteristics of paranoid and nonparanoid subtypes of schizophrenia. In a multicenter, randomized, controlled, longitudinal study, 374 clinically stable schizophrenia patients were interviewed at entry with standardized assessment instruments and followed for 12-26 months. In the multivariate analysis, male sex, married marital status, urban abode, and more frequent relapse over the study period were independently associated with paranoid schizophrenia. The socio-demographic and clinical characteristics of Chinese patients with the paranoid subtype of schizophrenia are different from those of their Caucasian counterparts who are more likely to be women and have a better outcome. © 2010 Wiley Periodicals, Inc.

Accuracy of computer-guided surgery for dental implant placement in fully edentulous patients: A systematic review

PubMed Central

Marlière, Daniel Amaral Alves; Demétrio, Maurício Silva; Picinini, Leonardo Santos; De Oliveira, Rodrigo Guerra; Chaves Netto, Henrique Duque De Miranda

2018-01-01

Assess clinical studies regarding accuracy between virtual planning of computer-guided surgery and actual outcomes of dental implant placements in total edentulous alveolar ridges. A PubMed search was performed to identify only clinical studies published between 2011 and 2016, searching the following combinations of keywords: “Accuracy AND Computer-Assisted Surgery AND Dental Implants.” Study designs were identified using the terms: Case Reports, Clinical study, Randomized Controlled Trial, Systematic Reviews, Meta-Analysis, humans. Level of agreement between the authors in the study selection process was substantial (k = 0.767), and the study eligibility was considered excellent (k = 0.863). Seven articles were included in this review. They describe the use of bone and muco-supported guides, demonstrating angular deviations cervically and apically ranging from (minimum and maximum means), respectively, 1.85–8.4 (°), 0.17–2.17 (mm), and 0.77–2.86 (mm). Angular deviations obtained most inaccuracy in maxila. For cervical and apical deviations, accuracy was preponderantly lower in maxilla. Despite the similar deviations measurement approaches described, clinical relevance of this study may be useful to warn the surgeon that safety margins in clinical situations. PMID:29657542

The application of disease management to clinical trial designs.

PubMed

Puterman, Jared; Alter, David A

2009-08-01

The utilization of disease management (DM) as a minimum standard of care is believed to facilitate pronounced benefits in overall patient outcome and cost management. Randomized clinical trials remain the gold standard evaluative tool in clinical medicine. However, the extent to which contemporary cardiovascular clinical trials incorporate DM components into their treatment or control arms is unknown. Our study is the first to evaluate the extent to which clinical trials incorporate DM as a minimum standard of care for both the intervention and control groups. In total, 386 clinical trials published in 3 leading medical journals between 2003 and 2006 were evaluated. For each study, elements related to DM care, as defined using the American Heart Association Taxonomy, were abstracted and characterized. Our results demonstrate that while the application of DM has increased over time, only 3.4% of the clinical trials examined incorporated all 8 DM elements (and only 11% of such trials incorporated 4 DM elements). A significant association was found between study year and the inclusion of more than 3 elements of DM (chi(2) = 10.10 (3); p = 0.018). In addition, associations were found between study objective and DM criteria, as well as between cohort type and domains described. Our study serves as a baseline reference for the tracking of DM within, and its application to, randomized clinical trials. Moreover, our results underscore the need for broader implementation and evaluation of DM as a minimum care standard within clinical trial research.

Genomic markers for decision making: what is preventing us from using markers?

PubMed

Coyle, Vicky M; Johnston, Patrick G

2010-02-01

The advent of novel genomic technologies that enable the evaluation of genomic alterations on a genome-wide scale has significantly altered the field of genomic marker research in solid tumors. Researchers have moved away from the traditional model of identifying a particular genomic alteration and evaluating the association between this finding and a clinical outcome measure to a new approach involving the identification and measurement of multiple genomic markers simultaneously within clinical studies. This in turn has presented additional challenges in considering the use of genomic markers in oncology, such as clinical study design, reproducibility and interpretation and reporting of results. This Review will explore these challenges, focusing on microarray-based gene-expression profiling, and highlights some common failings in study design that have impacted on the use of putative genomic markers in the clinic. Despite these rapid technological advances there is still a paucity of genomic markers in routine clinical use at present. A rational and focused approach to the evaluation and validation of genomic markers is needed, whereby analytically validated markers are investigated in clinical studies that are adequately powered and have pre-defined patient populations and study endpoints. Furthermore, novel adaptive clinical trial designs, incorporating putative genomic markers into prospective clinical trials, will enable the evaluation of these markers in a rigorous and timely fashion. Such approaches have the potential to facilitate the implementation of such markers into routine clinical practice and consequently enable the rational and tailored use of cancer therapies for individual patients.

Clinical decision-making among new graduate nurses attending residency programs in Saudi Arabia.

PubMed

Al-Dossary, Reem Nassar; Kitsantas, Panagiota; Maddox, P J

2016-02-01

This study examined the impact of residency programs on clinical decision-making of new Saudi graduate nurses who completed a residency program compared to new Saudi graduate nurses who did not participate in residency programs. This descriptive study employed a convenience sample (N=98) of new graduate nurses from three hospitals in Saudi Arabia. A self-administered questionnaire was used to collect data. Clinical decision-making skills were measured using the Clinical Decision Making in Nursing Scale. Descriptive statistics, independent t-tests, and multiple linear regression analysis were utilized to examine the effect of residency programs on new graduate nurses' clinical decision-making skills. On average, resident nurses had significantly higher levels of clinical decision-making skills than non-residents (t=23.25, p=0.000). Enrollment in a residency program explained 86.9% of the variance in total clinical decision making controlling for age and overall grade point average. The findings of this study support evidence in the nursing literature conducted primarily in the US and Europe that residency programs have a positive influence on new graduate nurses' clinical decision-making skills. This is the first study to examine the impact of residency programs on clinical decision-making among new Saudi graduate nurses who completed a residency program. The findings of this study underscore the need for the development and implementation of residency programs for all new nurses. Copyright © 2015 Elsevier Inc. All rights reserved.

A meta-analysis of mammographic screening with and without clinical breast examination

PubMed Central

Hamashima, Chisato; Ohta, Koji; Kasahara, Yoshio; Katayama, Takafumi; Nakayama, Tomio; Honjo, Satoshi; Ohnuki, Koji

2015-01-01

Mammographic screening with clinical breast examination has been recommended in Japan since 2000. Although mammographic screening without clinical breast examination has not been recommended, its introduction is anticipated. The efficacies of mammographic screening with and without clinical breast examination were evaluated based on the results of randomized controlled trials. PubMed and other databases for studies published between 1985 and 2014 were searched. The study design was limited to randomized controlled trials to evaluate mortality reduction from breast cancer. Five studies were eligible for meta-analysis of mammographic screening without clinical breast examination. The relative risk for women aged 40–74 years was 0.75 (95% confidence interval, 0.67–0.83). Three studies evaluated the efficacy of mammographic screening with clinical breast examination. The relative risk for women aged 40–64 years was 0.87 (95% confidence interval, 0.77–0.98). The number needed to invite was always lower in mammographic screening without clinical breast examination than in mammographic screening with clinical breast examination. In both screening methods, the number needed to invite was higher in women aged 40–49 years than in women aged 50–70 years. These results suggest that mammographic screening without clinical breast examination can afford higher benefits to women aged 50 years and over. Although evidence of the efficacy of mammographic screening without clinical breast examination was confirmed based on the results of the randomized controlled trials, a Japanese study is needed to resolve local problems. PMID:25959787

Iranian Clinical Nurses’ Activities for Self-Directed Learning: A Qualitative Study

PubMed Central

Ghiyasvandian, Shahrzad; Malekian, Morteza; Cheraghi, Mohammad Ali

2016-01-01

Background: Clinical nurses need lifelong learning skills for responding to the rapid changes of clinical settings. One of the best strategies for lifelong learning is self-directed learning. The aim of this study was to explore Iranian clinical nurses’ activities for self-directed learning. Methods: In this qualitative study, 23 semi-structured personal interviews were conducted with nineteen clinical nurses working in all four hospitals affiliated to Isfahan Social Security Organization, Isfahan, Iran. Study data were analyzed by using the content analysis approach. The study was conducted from June 2013 to October 2014. Findings: Study participants’ activities for self-directed learning fell into two main categories of striving for knowledge acquisition and striving for skill development. The main theme of the study was ‘Revising personal performance based on intellectual-experiential activities’. Conclusions: Study findings suggest that Iranian clinical nurses continually revise their personal performance by performing self-directed intellectual and experiential activities to acquire expertise. The process of acquiring expertise is a linear process which includes two key steps of knowledge acquisition and knowledge development. In order to acquire and advance their knowledge, nurses perform mental learning activities such as sensory perception, self-evaluation, and suspended judgment step-by-step. Moreover, they develop their skills through doing activities like apprenticeship, masterly performance, and self-regulation. The absolute prerequisite to expertise acquisition is that a nurse needs to follow these two steps in a sequential manner. PMID:26652072

The effects of clinical supervision on supervisees and patients in cognitive-behavioral therapy: a study protocol for a systematic review.

PubMed

Alfonsson, Sven; Spännargård, Åsa; Parling, Thomas; Andersson, Gerhard; Lundgren, Tobias

2017-05-11

Clinical supervision by a senior therapist is a very common practice in psychotherapist training and psychiatric care settings. Though clinical supervision is advocated by most educational and governing institutions, the effects of clinical supervision on the supervisees' competence, e.g., attitudes, behaviors, and skills, as well as on treatment outcomes and other patient variables are debated and largely unknown. Evidence-based practice is advocated in clinical settings but has not yet been fully implemented in educational or clinical training settings. The aim of this systematic review is to synthesize and present the empirical literature regarding effects of clinical supervision in cognitive-behavioral therapy. This study will include a systematic review of the literature to identify studies that have empirically investigated the effects of supervision on supervised psychotherapists and/or the supervisees' patients. A comprehensive search strategy will be conducted to identify published controlled studies indexed in the MEDLINE, EMBASE, PsycINFO, and Cochrane Library databases. Data on supervision outcomes in both psychotherapists and their patients will be extracted, synthesized, and reported. Risk of bias and quality of the included studies will be assessed systematically. This systematic review will rigorously follow established guidelines for systematic reviews in order to summarize and present the evidence base for clinical supervision in cognitive-behavioral therapy and may aid further research and discussion in this area. PROSPERO CRD42016046834.

Regulatory considerations on new adjuvants and delivery systems.

PubMed

Sesardic, D

2006-04-12

New and improved vaccines and delivery systems are increasingly being developed for prevention, treatment and diagnosis of human diseases. Prior to their use in humans, all new biological products must undergo pre-clinical evaluation. These pre-clinical studies are important not only to establish the biological properties of the material and to evaluate its possible risk to the public, but also to plan protocols for subsequent clinical trials from which safety and efficacy can be evaluated. For vaccines, evaluation in pre-clinical studies is particularly important as information gained may also contribute to identifying the optimum composition and formulation process and provide an opportunity to develop suitable indicator tests for quality control. Data from pre-clinical and laboratory evaluation studies, which continue during clinical studies, is used to support an application for marketing authorisation. Addition of a new adjuvant and exploration of new delivery systems for vaccines presents challenges to both manufacturers and regulatory authorities. Because no adjuvant is licensed as a medicinal product in its own right, but only as a component of a particular vaccine, pre-clinical and appropriate toxicology studies need to be designed on a case-by-case basis to evaluate the safety profile of the adjuvant and adjuvant/vaccine combination. Current regulatory requirements for the pharmaceutical and pre-clinical safety assessment of vaccines are insufficient and initiatives are in place to develop more specific guidelines for evaluation of adjuvants in vaccines.

Statistical Design for Biospecimen Cohort Size in Proteomics-based Biomarker Discovery and Verification Studies

PubMed Central

Skates, Steven J.; Gillette, Michael A.; LaBaer, Joshua; Carr, Steven A.; Anderson, N. Leigh; Liebler, Daniel C.; Ransohoff, David; Rifai, Nader; Kondratovich, Marina; Težak, Živana; Mansfield, Elizabeth; Oberg, Ann L.; Wright, Ian; Barnes, Grady; Gail, Mitchell; Mesri, Mehdi; Kinsinger, Christopher R.; Rodriguez, Henry; Boja, Emily S.

2014-01-01

Protein biomarkers are needed to deepen our understanding of cancer biology and to improve our ability to diagnose, monitor and treat cancers. Important analytical and clinical hurdles must be overcome to allow the most promising protein biomarker candidates to advance into clinical validation studies. Although contemporary proteomics technologies support the measurement of large numbers of proteins in individual clinical specimens, sample throughput remains comparatively low. This problem is amplified in typical clinical proteomics research studies, which routinely suffer from a lack of proper experimental design, resulting in analysis of too few biospecimens to achieve adequate statistical power at each stage of a biomarker pipeline. To address this critical shortcoming, a joint workshop was held by the National Cancer Institute (NCI), National Heart, Lung and Blood Institute (NHLBI), and American Association for Clinical Chemistry (AACC), with participation from the U.S. Food and Drug Administration (FDA). An important output from the workshop was a statistical framework for the design of biomarker discovery and verification studies. Herein, we describe the use of quantitative clinical judgments to set statistical criteria for clinical relevance, and the development of an approach to calculate biospecimen sample size for proteomic studies in discovery and verification stages prior to clinical validation stage. This represents a first step towards building a consensus on quantitative criteria for statistical design of proteomics biomarker discovery and verification research. PMID:24063748

Statistical design for biospecimen cohort size in proteomics-based biomarker discovery and verification studies.

PubMed

Skates, Steven J; Gillette, Michael A; LaBaer, Joshua; Carr, Steven A; Anderson, Leigh; Liebler, Daniel C; Ransohoff, David; Rifai, Nader; Kondratovich, Marina; Težak, Živana; Mansfield, Elizabeth; Oberg, Ann L; Wright, Ian; Barnes, Grady; Gail, Mitchell; Mesri, Mehdi; Kinsinger, Christopher R; Rodriguez, Henry; Boja, Emily S

2013-12-06

Protein biomarkers are needed to deepen our understanding of cancer biology and to improve our ability to diagnose, monitor, and treat cancers. Important analytical and clinical hurdles must be overcome to allow the most promising protein biomarker candidates to advance into clinical validation studies. Although contemporary proteomics technologies support the measurement of large numbers of proteins in individual clinical specimens, sample throughput remains comparatively low. This problem is amplified in typical clinical proteomics research studies, which routinely suffer from a lack of proper experimental design, resulting in analysis of too few biospecimens to achieve adequate statistical power at each stage of a biomarker pipeline. To address this critical shortcoming, a joint workshop was held by the National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), and American Association for Clinical Chemistry (AACC) with participation from the U.S. Food and Drug Administration (FDA). An important output from the workshop was a statistical framework for the design of biomarker discovery and verification studies. Herein, we describe the use of quantitative clinical judgments to set statistical criteria for clinical relevance and the development of an approach to calculate biospecimen sample size for proteomic studies in discovery and verification stages prior to clinical validation stage. This represents a first step toward building a consensus on quantitative criteria for statistical design of proteomics biomarker discovery and verification research.

In utero exposure to valproic acid and autism--a current review of clinical and animal studies.

PubMed

Roullet, Florence I; Lai, Jonathan K Y; Foster, Jane A

2013-01-01

Valproic acid (VPA) is both an anti-convulsant and a mood stabilizer. Clinical studies over the past 40 years have shown that exposure to VPA in utero is associated with birth defects, cognitive deficits, and increased risk of autism. Two recent FDA warnings related to use of VPA in pregnancy emphasize the need to reevaluate its use clinically during child-bearing years. The emerging clinical evidence showing a link between VPA exposure and both cognitive function and risk of autism brings to the forefront the importance of understanding how VPA exposure influences neurodevelopment. In the past 10 years, animal studies have investigated anatomical, behavioral, molecular, and physiological outcomes related to in utero VPA exposure. Behavioral studies show that VPA exposure in both rats and mice leads to autistic-like behaviors in the offspring, including social behavior deficits, increased repetitive behaviors, and deficits in communication. Based on this work VPA maternal challenge in rodents has been proposed as an animal model to study autism. This model has both face and construct validity; however, like all animal models there are limitations to its translation to the clinical setting. Here we provide a review of clinical studies that examined pregnancy outcomes of VPA use as well as the related animal studies. Copyright © 2013 Elsevier Inc. All rights reserved.

Overview of clinical research design.

PubMed

Hartung, Daniel M; Touchette, Daniel

2009-02-15

Basic concepts and terminology of clinical research design are presented for new clinical investigators. Clinical research, research involving human subjects, can be described as either observational or experimental. The findings of all clinical research can be threatened by issues of bias and confounding. Biases are systematic errors in how study subjects are selected or measured, which result in false inferences. Confounding is a distortion in findings that is attributable to mixing variable effects. Uncontrolled observation research is generally more prone to bias and confounding than experimental research. Observational research includes designs such as the cohort study, case-control study, and cross-sectional study, while experimental research typically involves a randomized controlled trial (RCT). The cohort study, which includes the RCT, defines subject allocation on the basis of exposure interest (e.g., drug, disease-management program) and follows the patients to assess the outcomes. The case-control study uses the primary outcome of interest (e.g., adverse event) to define subject allocation, and different exposures are assessed in a retrospective manner. Cross-sectional research evaluates both exposure and outcome concurrently. Each of these design methods possesses different strengths and weaknesses in answering research questions, as well as underlying many study subtypes. While experimental research is the strongest method for establishing causality, it can be difficult to accomplish under many scenarios. Observational clinical research offers many design alternatives that may be appropriate if planned and executed carefully.

Clinical performance of direct versus indirect composite restorations in posterior teeth: A systematic review.

PubMed

Azeem, Rubeena Abdul; Sureshbabu, Nivedhitha Malli

2018-01-01

Composite resin, serves as esthetic alternative to amalgam and cast restorations. Posterior teeth can be restored using direct or indirect composite restorations. The selection between direct and indirect technique is a clinically challenging decision-making process. Most important influencing factor is the amount of remaining tooth substance. The aim of this systematic review was to compare the clinical performance of direct versus indirect composite restorations in posterior teeth. The databases searched included PubMed CENTRAL (until July 2015), Medline, and Cochrane Database of Systematic Reviews. The bibliographies of clinical studies and reviews identified in the electronic search were analyzed to identify studies which were published outside the electronically searched journals. The primary outcome measure was evaluation of the survival of direct and indirect composite restorations in posterior teeth. This review included thirteen studies in which clinical performance of various types of direct and indirect composite restorations in posterior teeth were compared. Out of the thirteen studies which were included seven studies had a high risk of bias and five studies had a moderate risk of bias. One study having a low risk of bias, concluded that there was no significant difference between direct and indirect technique. However, the available evidence revealed inconclusive results. Further research should focus on randomized controlled trials with long term follow-up to give concrete evidence on the clinical performce of direct and indirect composite restorations.

Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series.

PubMed

Adam, Gaelen P; Springs, Stacey; Trikalinos, Thomas; Williams, John W; Eaton, Jennifer L; Von Isenburg, Megan; Gierisch, Jennifer M; Wilson, Lisa M; Robinson, Karen A; Viswanathan, Meera; Middleton, Jennifer Cook; Forman-Hoffman, Valerie L; Berliner, Elise; Kaplan, Robert M

2018-04-16

We investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews. We considered five reviews that included 495 studies total. Each review team conducted a search of ClinicalTrials.gov up to the date of the review's last literature search, screened the records using the review's eligibility criteria, extracted information, and assessed risk of bias and applicability. Each team then evaluated the impact of the evidence found in ClinicalTrials.gov on the conclusions in the review. Across the five reviews, the number of studies that had both a registry record and a publication varied widely, from none in one review to 43% of all studies identified in another. Among the studies with both a record and publication, there was also wide variability in the match between published outcomes and those listed in ClinicalTrials.gov. Of the 173 total ClinicalTrials.gov records identified across the five projects, between 11 and 43% did not have an associated publication. In the 14% of records that contained results, the new data provided in the ClinicalTrials.gov records did not change the results or conclusions of the reviews. Finally, a large number of published studies were not registered in ClinicalTrials.gov, but many of these were published before ClinicalTrials.gov's inception date of 2000. Improved prospective registration of trials and consistent reporting of results in ClinicalTrials.gov would help make ClinicalTrials.gov records more useful in finding unpublished information and identifying potential biases. In addition, consistent indexing in databases, such as MEDLINE, would allow for better matching of records and publications, leading to increased utility of these searches for systematic review projects.

Self-Esteem, Oral Health Behaviours, and Clinical Oral Health Status in Chinese Adults: An Exploratory Study

ERIC Educational Resources Information Center

Chin, Luzy Siu-Hei; Chan, Joanne Chung-Yan

2013-01-01

Objectives: This is an exploratory study to examine the relations among self-esteem, oral health behaviours and clinical oral health status in Chinese adults. In addition, gender differences in clinical oral health status and oral health behaviours were explored. Methods: Participants were 192 patients from a private dental clinic in Hong Kong…

[Methodology for clinical research in Orthodontics, the assets of the beOrtho website].

PubMed

Ruiz, Martial; Thibult, François

2014-06-01

The rules applying to the "evidence-based" methodology strongly influenced the clinical research in orthodontics. However, the implementation of clinical studies requires rigour, important statistical and methodological knowledge, as well as a reliable environment in order to compile and store the data obtained from research. We developed the project "beOrtho.com" (based on orthodontic evidence) in order to fill up the gap between our desire to drive clinical research and the necessity of methodological rigour in the exploitation of its results. BeOrtho website was created to answer the issue of sample recruitment, data compilation and storage, while providing help for the methodological design of clinical studies. It allows the development and monitoring of clinical studies, as well as the creation of databases. On the other hand, we designed an evaluation grid for clinical studies which helps developing systematic reviews. In order to illustrate our point, we tested a research protocol evaluating the interest of the mandibular advancement in the framework of Class II treatment. © EDP Sciences, SFODF, 2014.

Assessing Risk/Benefit for Trials Using Preclinical Evidence: A Proposal

PubMed Central

Kimmelman, Jonathan; Henderson, Valerie C.

2015-01-01

Abstract Moral evaluation of risk/benefit in early phase studies requires assessing the clinical promise of a candidate intervention using preclinical evidence. Yet there is little to guide ethics committees, investigators, sponsors or other stakeholders morally charged with making these assessments (“evaluators”). In what follows, we draw on published guidelines for preclinical study design to develop a structured process for assessing the clinical promise of new interventions. In the first step, evaluators gather all relevant preclinical studies, assess the magnitude of treatment effects, and determine clinical promise in light of various threats to valid clinical inference. In the second step, evaluators adjust assessments of clinical promise from preclinical studies by examining how other agents in the same reference class-and supported by similar evidence- have fared in clinical development. Assessments of clinical promise can then be fed into moral evaluation of risk and benefit in early phase trials. Though our approach has limitations, it offers a systematic and transparent method for assessing risk/benefit in early phase trials of novel interventions. PMID:26463620

Determining problems experienced by student nurses in their work with clinical educators in Turkey.

PubMed

Elcigil, Ayfer; Yildirim Sari, Hatice

2007-07-01

Clinical education is considered an indispensable and vital part of nursing education. Educators have an important role in the successful completion of a student's clinical education. The clinical educator's approach, experience and knowledge have an influence on the students. Students encounter certain problems during their clinical practice under the supervision of educators. This study was conducted to determine the nature of the problems student nurses encounter during clinical training in Turkey. The focus-group interviews were used for this study. Three groups of 8, a total group of 24, composed of students completing their third year were included in the interviews. The students in this study had completed their practical training in the departments of internal medicine, surgery, pediatrics, psychiatry and public health. Among the problems mostly encountered by students, as established by the study, were inadequate assessment by the clinical educator, judgment, negative feedback, communication problems, inadequate guidance and overload. At the end of the research, recommendations were that educators should offer information in the direction of student expectations, increase their positive feedback and lighten the academic workload of these students.

Clinical trials in "emerging markets": regulatory considerations and other factors.

PubMed

Singh, Romi; Wang, Ouhong

2013-11-01

Clinical studies are being placed in emerging markets as part of global drug development programs to access large pool of eligible patients and to benefit from a cost effective structure. However, over the last few years, the definition of "emerging markets" is being revisited, especially from a regulatory perspective. For purposes of this article, countries outside US, EU and the traditional "western countries" are discussed. Multiple factors are considered for placement of clinical studies such as adherence to Good Clinical Practice (GCP), medical infrastructure & standard of care, number of eligible patients, etc. This article also discusses other quantitative factors such as country's GDP, patent applications, healthcare expenditure, healthcare infrastructure, corruption, innovation, etc. These different factors and indexes are correlated to the number of clinical studies ongoing in the "emerging markets". R&D, healthcare expenditure, technology infrastructure, transparency, and level of innovation, show a significant correlation with the number of clinical trials being conducted in these countries. This is the first analysis of its kind to evaluate and correlate the various other factors to the number of clinical studies in a country. © 2013.

Stressors and expectations of undergraduate nursing students during clinical practice in Singapore.

PubMed

Suen, Wei Qi; Lim, Siriwan; Wang, Wenru; Kowitlawakul, Yanika

2016-12-01

Nursing students have experienced stress because they need to focus on academic performance while being exposed to a clinical environment. The study aimed to identify the contributing factors of stress and the clinical environment expectations of undergraduate nursing students during their clinical practice at a university in Singapore. A cross-sectional descriptive study design using validated surveys was adopted. The Stressors in Nursing Students and the Clinical Learning Environment Inventory questionnaires were used to collect the data in January 2014. A total of 285 nursing students participated in this study. The results showed that third year nursing students had higher stress levels than first year and second year students. Satisfaction in terms of fulfilment among nursing students during clinical practice was found to be the most influential factor in predicting stress. The study suggests that the nursing faculty needs to be more concerned about nursing students' stress level and provide more support to third year students. In addition, students' satisfaction should be considered when developing a clinical curriculum. © 2016 John Wiley & Sons Australia, Ltd.

Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry.

PubMed

Perlis, Roy H; Perlis, Clifford S; Wu, Yelena; Hwang, Cindy; Joseph, Megan; Nierenberg, Andrew A

2005-10-01

Financial conflict of interest has been reported to be prevalent in clinical trials in general medicine and associated with a greater likelihood of reporting results favorable to the intervention being studied. The extent and implications of industry sponsorship and financial conflict of interest in psychiatric clinical trials have not been investigated, to the authors' knowledge. The authors examined funding source and author financial conflict of interest in all clinical trials published in the American Journal of Psychiatry, the Archives of General Psychiatry, the Journal of Clinical Psychopharmacology, and the Journal of Clinical Psychiatry between 2001 and 2003. Among 397 clinical trials identified, 239 (60%) reported receiving funding from a pharmaceutical company or other interested party, and 187 studies (47%) included at least one author with a reported financial conflict of interest. Among the 162 randomized, double-blind, placebo-controlled studies examined, those that reported conflict of interest were 4.9 times more likely to report positive results; this association was significant only among the subset of pharmaceutical industry-funded studies. Author conflict of interest appears to be prevalent among psychiatric clinical trials and to be associated with a greater likelihood of reporting a drug to be superior to placebo.

Intercultural Usage of Mori Folium: Comparison Review from a Korean Medical Perspective

PubMed Central

Joh, Byungjin; Jeon, Eun Sang; Lim, Su Hye; Park, Yu Lee; Park, Wansu

2015-01-01

Objectives. A review on studies related to the use of Mori folium, the leaves of Morus alba, was conducted with the goal of identifying new clinical applications in Korean medicine. Methods. Global literature search was conducted using three electronic databases up to January 2015 with the term Morus alba and its Korean terms. KM literatures including textbooks and standard pharmacopoeia were separately hand-searched and reviewed to provide comparison. Data were extracted according to predetermined criteria, and clinical uses were standardized with ICD-10 categories. Results. 159 potentially relevant studies were identified, and 18 articles including 12 ethnopharmacologic and 6 clinical studies were finally included in this analysis. Ethnopharmacologic studies from 8 countries provided 17 clinical uses. We found that five out of six clinical trials were related to diabetes and suggested a moderate short-term to mild long-term effect. And 43 Korean texts also provided 156 clinical uses in 35 categories including ocular and respiratory disorders. Discussion and Conclusions. Though majority of the clinical uses were also found in Korean medicine literature, treatment of infertility, jaundice, cognitive disorder, and hyperpigmentation was found to be effective and diabetes with Morus alba was recognized to have clinical importance. PMID:26539223

Prevalence, aetiology and antibiotic sensitivity profile of asymptomatic bacteriuria isolates from pregnant women in selected antenatal clinic from Nairobi, Kenya.

PubMed

Ayoyi, Adelaide Ogutu; Kikuvi, Gideon; Bii, Christine; Kariuki, Samuel

2017-01-01

Asymptomatic bacteriuria (ASB) is the presence of bacteria in urine without apparent symptoms of urinary tract infections. The importance of asymptomatic bacteriuria lies in the insight it provides into symptomatic infections. To determine prevalence, bacterial isolates and Antibiotic Sensitivity Profile of asymptomatic bacterial urinary tract infection in pregnant women in selected clinics in Nairobi. This was a cross-sectional study involving women attending antenatal clinic at selected clinics of Nairobi County. The women who met the inclusion criteria were included in the study. The midstream urine samples of these women were subjected to microscopy, culture and sensitivity. A total of 1020 of women on their first antenatal clinic visit participated in the study; 219 of them had ASB, giving a prevalence of 21.5 % at 95% confidence level. Escherichia coli were the common organism isolated at 38.8%. The majority of the organisms were sensitive to imipenem and gentamycin. There is a high prevalence of ASB among pregnant women included in the study from the Nairobi county clinics. Therefore, routine ASB screening of pregnant women is recommended among the women attending antennal clinics in Nairobi county clinics.

Prevalence, aetiology and antibiotic sensitivity profile of asymptomatic bacteriuria isolates from pregnant women in selected antenatal clinic from Nairobi, Kenya

PubMed Central

Ayoyi, Adelaide Ogutu; Kikuvi, Gideon; Bii, Christine; Kariuki, Samuel

2017-01-01

Introduction Asymptomatic bacteriuria (ASB) is the presence of bacteria in urine without apparent symptoms of urinary tract infections. The importance of asymptomatic bacteriuria lies in the insight it provides into symptomatic infections. To determine prevalence, bacterial isolates and Antibiotic Sensitivity Profile of asymptomatic bacterial urinary tract infection in pregnant women in selected clinics in Nairobi. Methods This was a cross-sectional study involving women attending antenatal clinic at selected clinics of Nairobi County. The women who met the inclusion criteria were included in the study. The midstream urine samples of these women were subjected to microscopy, culture and sensitivity. Results A total of 1020 of women on their first antenatal clinic visit participated in the study; 219 of them had ASB, giving a prevalence of 21.5 % at 95% confidence level. Escherichia coli were the common organism isolated at 38.8%. The majority of the organisms were sensitive to imipenem and gentamycin. Conclusion There is a high prevalence of ASB among pregnant women included in the study from the Nairobi county clinics. Therefore, routine ASB screening of pregnant women is recommended among the women attending antennal clinics in Nairobi county clinics. PMID:28451019

Expertise in Clinical Psychology. The Effects of University Training and Practical Experience on Expertise in Clinical Psychology

PubMed Central

Vollmer, Sabine; Spada, Hans; Caspar, Franz; Burri, Salome

2013-01-01

How do university training and subsequent practical experience affect expertise in clinical psychology? To answer this question we developed methods to assess psychological knowledge and the competence to diagnose, construct case conceptualizations, and plan psychotherapeutic treatment: a knowledge test and short case studies in a first study, and a complex, dynamically evolving case study in the second study. In our cross-sectional studies, psychology students, trainees in a certified postgraduate psychotherapist curriculum, and behavior therapists with more than 10 years of experience were tested (100 in total: 20 each of novice, intermediate, and advanced university students, postgraduate trainees, and therapists). Clinical knowledge and competence increased up to the level of trainees but unexpectedly decreased at the level of experienced therapists. We discuss the results against the background of expertise research and the training of clinical psychologists (in Germany). Important factors for the continuing professional development of psychotherapists are proposed. PMID:23543213

Improving the quality of cognitive screening assessments: ACEmobile, an iPad-based version of the Addenbrooke's Cognitive Examination-III.

PubMed

Newman, Craig G J; Bevins, Adam D; Zajicek, John P; Hodges, John R; Vuillermoz, Emil; Dickenson, Jennifer M; Kelly, Denise S; Brown, Simona; Noad, Rupert F

2018-01-01

Ensuring reliable administration and reporting of cognitive screening tests are fundamental in establishing good clinical practice and research. This study captured the rate and type of errors in clinical practice, using the Addenbrooke's Cognitive Examination-III (ACE-III), and then the reduction in error rate using a computerized alternative, the ACEmobile app. In study 1, we evaluated ACE-III assessments completed in National Health Service (NHS) clinics ( n  = 87) for administrator error. In study 2, ACEmobile and ACE-III were then evaluated for their ability to capture accurate measurement. In study 1, 78% of clinically administered ACE-IIIs were either scored incorrectly or had arithmetical errors. In study 2, error rates seen in the ACE-III were reduced by 85%-93% using ACEmobile. Error rates are ubiquitous in routine clinical use of cognitive screening tests and the ACE-III. ACEmobile provides a framework for supporting reduced administration, scoring, and arithmetical error during cognitive screening.

Outcome Measures in Spinal Cord Injury

PubMed Central

Alexander, Marcalee S.; Anderson, Kim; Biering-Sorensen, Fin; Blight, Andrew R.; Brannon, Ruth; Bryce, Thomas; Creasey, Graham; Catz, Amiram; Curt, Armin; Donovan, William; Ditunno, John; Ellaway, Peter; Finnerup, Nanna B.; Graves, Daniel E.; Haynes, Beth Ann; Heinemann, Allen W.; Jackson, Amie B.; Johnston, Mark; Kalpakjian, Claire Z.; Kleitman, Naomi; Krassioukov, Andrei; Krogh, Klaus; Lammertse, Daniel; Magasi, Susan; Mulcahey, MJ; Schurch, Brigitte; Sherwood, Arthur; Steeves, John D.; Stiens, Steven; Tulsky, David S.; van Hedel, Hubertus J.A.; Whiteneck, Gale

2009-01-01

Study Design review by the Spinal Cord Outcomes Partnership Endeavor (SCOPE), which is a broad-based international consortium of scientists and clinical researchers representing academic institutions, industry, government agencies, not-for-profit organizations and foundations. Objectives assessment of current and evolving tools for evaluating human spinal cord injury (SCI) outcomes for both clinical diagnosis and clinical research studies. Methods a framework for the appraisal of evidence of metric properties was used to examine outcome tools or tests for accuracy, sensitivity, reliability and validity for human SCI. Results imaging, neurological, functional, autonomic, sexual health, bladder/bowel, pain, and psycho-social tools were evaluated. Several specific tools for human SCI studies have or are being developed to allow the more accurate determination for a clinically meaningful benefit (improvement in functional outcome or quality of life) being achieved as a result of a therapeutic intervention. Conclusion significant progress has been made, but further validation studies are required to identify the most appropriate tools for specific targets in a human SCI study or clinical trial. PMID:19381157

An evidence-based review of pregabalin for the treatment of fibromyalgia.

PubMed

Arnold, Lesley M; Choy, Ernest; Clauw, Daniel J; Oka, Hiroshi; Whalen, Ed; Semel, David; Pauer, Lynne; Knapp, Lloyd

2018-04-16

Pregabalin, an α2-δ agonist, is approved for the treatment of fibromyalgia (FM) in the United States, Japan, and 37 other countries. The purpose of this article was to provide an in-depth, evidence-based summary of pregabalin for FM as demonstrated in randomized, placebo-controlled clinical studies, including open-label extensions, meta-analyses, combination studies and post-hoc analyses of clinical study data. PubMed was searched using the term "pregabalin AND fibromyalgia" and the Cochrane Library with the term "pregabalin". Both searches were conducted on 2 March 2017 with no other date limits set. Eleven randomized, double-blind, placebo-controlled clinical studies were identified including parallel group, two-way crossover and randomized withdrawal designs. One was a neuroimaging study. Five open-label extensions were also identified. Evidence of efficacy was demonstrated across the studies identified with significant and clinically relevant improvements in pain, sleep quality and patient status. The safety and tolerability profile of pregabalin is consistent across all the studies identified, including in adolescents, with dizziness and somnolence the most common adverse events reported. These efficacy and safety data are supported by meta-analyses (13 studies). Pregabalin in combination with other pharmacotherapies (7 studies) is also efficacious. Post-hoc analyses have demonstrated the onset of pregabalin efficacy as early as 1-2 days after starting treatment, examined the effect of pregabalin on other aspects of sleep beyond quality, and shown it is effective irrespective of the presence of a wide variety of patient demographic and clinical characteristics. Pregabalin is a treatment option for FM; its clinical utility has been comprehensively demonstrated.

EXAMINING EVIDENCE IN U.S. PAYER COVERAGE POLICIES FOR MULTI-GENE PANELS AND SEQUENCING TESTS

PubMed Central

Chambers, James D.; Saret, Cayla J.; Anderson, Jordan E.; Deverka, Patricia A.; Douglas, Michael P.; Phillips, Kathryn A.

2017-01-01

Objectives The aim of this study was to examine the evidence payers cited in their coverage policies for multi-gene panels and sequencing tests (panels), and to compare these findings with the evidence payers cited in their coverage policies for other types of medical interventions. Methods We used the University of California at San Francisco TRANSPERS Payer Coverage Registry to identify coverage policies for panels issued by five of the largest US private payers. We reviewed each policy and categorized the evidence cited within as: clinical studies, systematic reviews, technology assessments, cost-effectiveness analyses (CEAs), budget impact studies, and clinical guidelines. We compared the evidence cited in these coverage policies for panels with the evidence cited in policies for other intervention types (pharmaceuticals, medical devices, diagnostic tests and imaging, and surgical interventions) as reported in a previous study. Results Fifty-five coverage policies for panels were included. On average, payers cited clinical guidelines in 84 percent of their coverage policies (range, 73–100 percent), clinical studies in 69 percent (50–87 percent), technology assessments 47 percent (33–86 percent), systematic reviews or meta-analyses 31 percent (7–71 percent), and CEAs 5 percent (0–7 percent). No payers cited budget impact studies in their policies. Payers less often cited clinical studies, systematic reviews, technology assessments, and CEAs in their coverage policies for panels than in their policies for other intervention types. Payers cited clinical guidelines in a comparable proportion of policies for panels and other technology types. Conclusions Payers in our sample less often cited clinical studies and other evidence types in their coverage policies for panels than they did in their coverage policies for other types of medical interventions. PMID:29065945

EXAMINING EVIDENCE IN U.S. PAYER COVERAGE POLICIES FOR MULTI-GENE PANELS AND SEQUENCING TESTS.

PubMed

Chambers, James D; Saret, Cayla J; Anderson, Jordan E; Deverka, Patricia A; Douglas, Michael P; Phillips, Kathryn A

2017-01-01

The aim of this study was to examine the evidence payers cited in their coverage policies for multi-gene panels and sequencing tests (panels), and to compare these findings with the evidence payers cited in their coverage policies for other types of medical interventions. We used the University of California at San Francisco TRANSPERS Payer Coverage Registry to identify coverage policies for panels issued by five of the largest US private payers. We reviewed each policy and categorized the evidence cited within as: clinical studies, systematic reviews, technology assessments, cost-effectiveness analyses (CEAs), budget impact studies, and clinical guidelines. We compared the evidence cited in these coverage policies for panels with the evidence cited in policies for other intervention types (pharmaceuticals, medical devices, diagnostic tests and imaging, and surgical interventions) as reported in a previous study. Fifty-five coverage policies for panels were included. On average, payers cited clinical guidelines in 84 percent of their coverage policies (range, 73-100 percent), clinical studies in 69 percent (50-87 percent), technology assessments 47 percent (33-86 percent), systematic reviews or meta-analyses 31 percent (7-71 percent), and CEAs 5 percent (0-7 percent). No payers cited budget impact studies in their policies. Payers less often cited clinical studies, systematic reviews, technology assessments, and CEAs in their coverage policies for panels than in their policies for other intervention types. Payers cited clinical guidelines in a comparable proportion of policies for panels and other technology types. Payers in our sample less often cited clinical studies and other evidence types in their coverage policies for panels than they did in their coverage policies for other types of medical interventions.

Participation in clinical research: perspectives of adult patients and parents of pediatric patients undergoing hematopoietic stem cell transplantation.

PubMed

Keusch, Florian; Rao, Rohini; Chang, Lawrence; Lepkowski, James; Reddy, Pavan; Choi, Sung Won

2014-10-01

Despite major improvements over the past several decades, many patients undergoing hematopoietic stem cell transplantations (HSCT) continue to suffer from significant treatment-related morbidity and mortality. Clinical research studies (trials) have been integral to advancing the standard of care in HSCT. However, 1 of the biggest challenges with clinical trials is the low participation rate. Although barriers to participation in cancer clinical trials have been previously explored, studies specific to HSCT are lacking. The current study was undertaken to examine the knowledge, attitudes, and perceptions of HSCT patients regarding clinical trials. As members of focus groups, participants responded to open-ended questions that assessed factors influencing decision-making about HSCT clinical trials. Suggestions for improvements in the recruitment process were also solicited among participants. Seventeen adult HSCT patients and 6 parents of pediatric HSCT patients participated in the study. The median age was 56 years (range, 18 to 70) and 44 years (range, 28 to 54) for adult patients and parents, respectively. Participants universally indicated that too much information was provided within the informed consents and they were intimidated by the medical and legal language. Despite the large amount of information provided to them at the time of study enrollment, the participants had limited knowledge retention and recall of study details. Nevertheless, participants reported overall positive experiences with clinical trial participation and many would readily choose to participate again. A common concern among participants was the uncertainty of study outcome and general lack of feedback about results at the end of the study. Participants suggested that investigators provide more condensed and easier to understand informed consents and follow-up of study findings. These findings could be used to help guide the development of improved consent documents and enhanced participation in research studies, thereby affecting the future design of HSCT research protocols. Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Platelet-Rich Fibrin and Soft Tissue Wound Healing: A Systematic Review.

PubMed

Miron, Richard J; Fujioka-Kobayashi, Masako; Bishara, Mark; Zhang, Yufeng; Hernandez, Maria; Choukroun, Joseph

2017-02-01

The growing multidisciplinary field of tissue engineering aims at predictably regenerating, enhancing, or replacing damaged or missing tissues for a variety of conditions caused by trauma, disease, and old age. One area of research that has gained tremendous awareness in recent years is that of platelet-rich fibrin (PRF), which has been utilized across a wide variety of medical fields for the regeneration of soft tissues. This systematic review gathered all the currently available in vitro, in vivo, and clinical literature utilizing PRF for soft tissue regeneration, augmentation, and/or wound healing. In total, 164 publications met the original search criteria, with a total of 48 publications meeting inclusion criteria (kappa score = 94%). These studies were divided into 7 in vitro, 11 in vivo, and 31 clinical studies. In summary, 6 out of 7 (85.7%) and 11 out of 11 (100%) of the in vitro and in vivo studies, respectively, demonstrated a statistically significant advantage for combining PRF to their regenerative therapies. Out of the remaining 31 clinical studies, a total of 8 reported the effects of PRF in a randomized clinical trial, with 5 additional studies (13 total) reporting appropriate controls. In those clinical studies, 9 out of the 13 studies (69.2%) demonstrated a statistically relevant positive outcome for the primary endpoints measured. In total, 18 studies (58% of clinical studies) reported positive wound-healing events associated with the use of PRF, despite using controls. Furthermore, 27 of the 31 clinical studies (87%) supported the use of PRF for soft tissue regeneration and wound healing for a variety of procedures in medicine and dentistry. In conclusion, the results from the present systematic review highlight the positive effects of PRF on wound healing after regenerative therapy for the management of various soft tissue defects found in medicine and dentistry.

Invited review: study design considerations for clinical research in veterinary radiology and radiation oncology.

PubMed

Scrivani, Peter V; Erb, Hollis N

2013-01-01

High quality clinical research is essential for advancing knowledge in the areas of veterinary radiology and radiation oncology. Types of clinical research studies may include experimental studies, method-comparison studies, and patient-based studies. Experimental studies explore issues relative to pathophysiology, patient safety, and treatment efficacy. Method-comparison studies evaluate agreement between techniques or between observers. Patient-based studies investigate naturally acquired disease and focus on questions asked in clinical practice that relate to individuals or populations (e.g., risk, accuracy, or prognosis). Careful preplanning and study design are essential in order to achieve valid results. A key point to planning studies is ensuring that the design is tailored to the study objectives. Good design includes a comprehensive literature review, asking suitable questions, selecting the proper sample population, collecting the appropriate data, performing the correct statistical analyses, and drawing conclusions supported by the available evidence. Most study designs are classified by whether they are experimental or observational, longitudinal or cross-sectional, and prospective or retrospective. Additional features (e.g., controlled, randomized, or blinded) may be described that address bias. Two related challenging aspects of study design are defining an important research question and selecting an appropriate sample population. The sample population should represent the target population as much as possible. Furthermore, when comparing groups, it is important that the groups are as alike to each other as possible except for the variables of interest. Medical images are well suited for clinical research because imaging signs are categorical or numerical variables that might be predictors or outcomes of diseases or treatments. © 2013 Veterinary Radiology & Ultrasound.

Common cold symptoms in children: results of an Internet-based surveillance program.

PubMed

Troullos, Emanuel; Baird, Lisa; Jayawardena, Shyamalie

2014-06-19

Conducting and analyzing clinical studies of cough and cold medications is challenging due to the rapid onset and short duration of the symptoms. The use of Internet-based surveillance tools is a new approach in clinical studies that is gradually becoming popular and may become a useful method of recruitment. As part of an initiative to assess the safety and efficacy of cough and cold ingredients in children 6-11 years of age, a surveillance program was proposed as a means to identify and recruit pediatric subjects for clinical studies. The objective of the study was to develop an Internet-based surveillance system and to assess the feasibility of using such a system to recruit children for common cold clinical studies, record the natural history of their cold symptoms, and determine the willingness of parents to have their children participate in clinical studies. Healthy potential subjects were recruited via parental contact online. During the 6-week surveillance period, parents completed daily surveys to record details of any cold symptoms in their children. If a child developed a cold, symptoms were followed via survey for 10 days. Additional questions evaluated the willingness of parents to have their children participate in a clinical study shortly after onset of symptoms. The enrollment target of 248 children was reached in approximately 1 week. Children from 4 distinct geographic regions of the United States were recruited. Parents reported cold symptoms in 163 children, and 134 went on to develop colds. The most prevalent symptoms were runny nose, stuffed-up nose, and sneezing. The most severe symptoms were runny nose, stuffed-up nose, and sore/scratchy throat. The severity of most symptoms peaked 1-2 days after onset. Up to 54% of parents expressed willingness to bring a sick child to a clinical center shortly after the onset of symptoms. Parents found the Internet-based surveys easy to complete. Internet-based surveillance and recruitment can be useful tools to follow colds in children and enroll subjects in clinical studies. However, study designs should account for a potentially high dropout rate and low rate of adherence to study procedures.

Clinical Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A Pragmatic Trial of Complex Treatment for a Complex Disorder

PubMed Central

Nierenberg, Andrew A.; Sylvia, Louisa G.; Leon, Andrew C.; Reilly-Harrington, Noreen; Shesler, Leah W.; McElroy, Susan L.; Friedman, Edward S.; Thase, Michael E.; Shelton, Richard C.; Bowden, Charles; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence; Kocsis, James; McInnis, Melvin G.; Schoenfeld, David; Bobo, William V.; Calabrese, Joseph R.

2015-01-01

Background Classic and second generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the “real-world” advantages and disadvantages of these medications Purpose We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This paper outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Methods Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments. The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool. Results The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus adjunctive personalized treatment (APT), across ten sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. 482 participants were randomized to the study and 364 completed. Limitations The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants’ ability to pay for study medications. Conclusion We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second generation antipsychotic with broad-spectrum activity in bipolar disorder and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial. PMID:24346608

Physiotherapists' beliefs and attitudes influence clinical practice in chronic low back pain: a systematic review of quantitative and qualitative studies.

PubMed

Gardner, Tania; Refshauge, Kathryn; Smith, Lorraine; McAuley, James; Hübscher, Markus; Goodall, Stephen

2017-07-01

What influence do physiotherapists' beliefs and attitudes about chronic low back pain have on their clinical management of people with chronic low back pain? Systematic review with data from quantitative and qualitative studies. Quantitative and qualitative studies were included if they investigated an association between physiotherapists' attitudes and beliefs about chronic low back pain and their clinical management of people with chronic low back pain. Five quantitative and five qualitative studies were included. Quantitative studies used measures of treatment orientation and fear avoidance to indicate physiotherapists' beliefs and attitudes about chronic low back pain. Quantitative studies showed that a higher biomedical orientation score (indicating a belief that pain and disability result from a specific structural impairment, and treatment is selected to address that impairment) was associated with: advice to delay return to work, advice to delay return to activity, and a belief that return to work or activity is a threat to the patient. Physiotherapists' fear avoidance scores were positively correlated with: increased certification of sick leave, advice to avoid return to work, and advice to avoid return to normal activity. Qualitative studies revealed two main themes attributed to beliefs and attitudes of physiotherapists who have a relationship to their management of chronic low back pain: treatment orientation and patient factors. Both quantitative and qualitative studies showed a relationship between treatment orientation and clinical practice. The inclusion of qualitative studies captured the influence of patient factors in clinical practice in chronic low back pain. There is a need to recognise that both beliefs and attitudes regarding treatment orientation of physiotherapists, and therapist-patient factors need to be considered when introducing new clinical practice models, so that the adoption of new clinical practice is maximised. [Gardner T, Refshauge K, Smith L, McAuley J, Hübscher M, Goodall S (2017) Physiotherapists' beliefs and attitudes influence clinical practice in chronic low back pain: a systematic review of quantitative and qualitative studies. Journal of Physiotherapy 63: 132-143]. Copyright © 2017 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

The use of mesenchymal stem cells for cartilage repair and regeneration: a systematic review.

PubMed

Goldberg, Andy; Mitchell, Katrina; Soans, Julian; Kim, Louise; Zaidi, Razi

2017-03-09

The management of articular cartilage defects presents many clinical challenges due to its avascular, aneural and alymphatic nature. Bone marrow stimulation techniques, such as microfracture, are the most frequently used method in clinical practice however the resulting mixed fibrocartilage tissue which is inferior to native hyaline cartilage. Other methods have shown promise but are far from perfect. There is an unmet need and growing interest in regenerative medicine and tissue engineering to improve the outcome for patients requiring cartilage repair. Many published reviews on cartilage repair only list human clinical trials, underestimating the wealth of basic sciences and animal studies that are precursors to future research. We therefore set out to perform a systematic review of the literature to assess the translation of stem cell therapy to explore what research had been carried out at each of the stages of translation from bench-top (in vitro), animal (pre-clinical) and human studies (clinical) and assemble an evidence-based cascade for the responsible introduction of stem cell therapy for cartilage defects. This review was conducted in accordance to PRISMA guidelines using CINHAL, MEDLINE, EMBASE, Scopus and Web of Knowledge databases from 1st January 1900 to 30th June 2015. In total, there were 2880 studies identified of which 252 studies were included for analysis (100 articles for in vitro studies, 111 studies for animal studies; and 31 studies for human studies). There was a huge variance in cell source in pre-clinical studies both of terms of animal used, location of harvest (fat, marrow, blood or synovium) and allogeneicity. The use of scaffolds, growth factors, number of cell passages and number of cells used was hugely heterogeneous. This review offers a comprehensive assessment of the evidence behind the translation of basic science to the clinical practice of cartilage repair. It has revealed a lack of connectivity between the in vitro, pre-clinical and human data and a patchwork quilt of synergistic evidence. Drivers for progress in this space are largely driven by patient demand, surgeon inquisition and a regulatory framework that is learning at the same pace as new developments take place.

Detection of Clinically Significant Retinopathy of Prematurity Using Wide-angle Digital Retinal Photography

PubMed Central

Chiang, Michael F.; Melia, Michele; Buffenn, Angela N.; Lambert, Scott R.; Recchia, Franco M.; Simpson, Jennifer L.; Yang, Michael B.

2013-01-01

Objective To evaluate the accuracy of detecting clinically significant retinopathy of prematurity (ROP) using wide-angle digital retinal photography. Methods Literature searches of PubMed and the Cochrane Library databases were conducted last on December 7, 2010, and yielded 414 unique citations. The authors assessed these 414 citations and marked 82 that potentially met the inclusion criteria. These 82 studies were reviewed in full text; 28 studies met inclusion criteria. The authors extracted from these studies information about study design, interventions, outcomes, and study quality. After data abstraction, 18 were excluded for study deficiencies or because they were superseded by a more recent publication. The methodologist reviewed the remaining 10 studies and assigned ratings of evidence quality; 7 studies were rated level I evidence and 3 studies were rated level III evidence. Results There is level I evidence from ≥5 studies demonstrating that digital retinal photography has high accuracy for detection of clinically significant ROP. Level III studies have reported high accuracy, without any detectable complications, from real-world operational programs intended to detect clinically significant ROP through remote site interpretation of wide-angle retinal photographs. Conclusions Wide-angle digital retinal photography has the potential to complement standard ROP care. It may provide advantages through objective documentation of clinical examination findings, improved recognition of disease progression by comparing previous photographs, and the creation of image libraries for education and research. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references. PMID:22541632

A Study of the Competency of Third Year Medical Students to Interpret Biochemically Based Clinical Scenarios Using Knowledge and Skills Gained in Year 1 and 2

ERIC Educational Resources Information Center

Gowda, Veena Bhaskar S.; Nagaiah, Bhaskar Hebbani; Sengodan, Bharathi

2016-01-01

Medical students build clinical knowledge on the grounds of previously obtained basic knowledge. The study aimed to evaluate the competency of third year medical students to interpret biochemically based clinical scenarios using knowledge and skills gained during year 1 and 2 of undergraduate medical training. Study was conducted on year 3 MBBS…

A Study of the Utilization Patterns of an Elementary School-Based Health Clinic over a 5-Year Period

ERIC Educational Resources Information Center

Johnson, Veda; Hutcherson, Valerie

2006-01-01

The purpose of this study was to determine the utilization pattern of an elementary school-based clinic over a 5-year period. It involved a retrospective analysis of computer-based data for all patient visits during this study period. Results revealed high clinic utilization with an average of over 5 encounters for all users each year. The most…

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual.

PubMed

Ghebre, Rahel G; Jones, Lovell A; Wenzel, Jennifer A; Martin, Michelle Y; Durant, Raegan W; Ford, Jean G

2014-04-01

Patient navigation programs are emerging that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process as well as outcome measures to evaluate program effectiveness. A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. The eligible studies reported on the development of programs for patient navigation in cancer clinical trials, including training and implementation among African Americans, American Indians, and Native Hawaiians. A low rate of clinical trial refusal (range, 4%-6%) was reported among patients enrolled in patient navigation programs. However, few studies reported on the efficacy of patient navigation in increasing clinical treatment trial enrollment. Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. © 2014 American Cancer Society.

State-of-the-Science of Patient Navigation as a Strategy for Enhancing Minority Clinical Trial Accrual

PubMed Central

Ghebre, Rahel G.; Jones, Lovell A.; Wenzel, Jennifer; Martin, Michelle Y.; Durant, Raegan; Ford, Jean G.

2014-01-01

Background Patient navigation programs are emerging, that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process, as well as outcome measures to evaluate program effectiveness. Methods A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. Results The eligible studies reported on development of programs for patient navigation in cancer clinical trials, including training and implementation among African American, American Indian and Native Hawaiians. Low clinical trial refusal, 4% to 6%, was reported among patients enrolled in patient navigation program. However, few studies reported on the efficacy of patient navigation on increasing clinical treatment trial enrollment. Conclusion Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. PMID:24643650

Impact of critical thinking disposition, general self-efficacy, and leadership on clinical competence in nursing students.

PubMed

Park, Jee Won; Kim, Chun Ja; Kim, Yong Soon; Yoo, Moon Sook; Yoo, Hyera; Chae, Sun Mi; Ahn, Jeong Ah

2012-09-01

The purpose of this study was to evaluate the relationships among critical thinking disposition, general self-efficacy, leadership and clinical competence, and identify the factors influencing clinical competence in nursing students. In this descriptive study, 153 nursing students (from 2nd to 4th school year) of a university in South Korea were enrolled in December 2010. The instruments for this study were the Korean versions of the Critical Thinking Disposition Scale, General Self-Efficacy Scale, Leadership Inventory, and Clinical Competence Scale. Data were analyzed by descriptive statistics, t-test, MANOVA, Pearson correlation, and multiple linear regression with PASW 18.0 software. The mean scores (ranging from 1 to 5) in nursing students for critical thinking disposition, general self-efficacy, leadership, and clinical competence were 3.44, 3.51, 3.55, and 3.42, respectively. Positive correlations were found for clinical competence with critical thinking disposition, general self-efficacy, and leadership. The strongest predictor of clinical competence was leadership. In addition, leadership, nursing school year, and subjective academic achievement accounted for 34.5% of variance in clinical competence. This study revealed that developing leadership, critical thinking disposition, and self-efficacy in undergraduate nursing education is important to improve clinical competence of nursing students.

Physician compensation for industry-sponsored clinical trials in multiple sclerosis influences patient trust.

PubMed

Klein, E; Solomon, A J; Corboy, J; Bernat, J

2016-07-01

Perceived physician financial conflicts of interest of can affect patient trust. Payment to physicians for industry sponsored clinical trials in multiple sclerosis is a relatively new potential source of physician conflict of interest. There is limited available data on how physician payment for trial involvement in multiple sclerosis clinical trials may influence patient trust. To understand how patient trust is influenced by information about physician payment for multiple sclerosis clinical trials. An anonymous online instrument was developed. 597 people with multiple sclerosis participated in the study. The study found that 61% of patients who had not previously participated in a clinical trial estimated that they would have lower levels of trust in their physician if the physician was paid for involvement in their clinical trial. Among former clinical trial participants, 38% self-reported a lower level of trust. Other potential physician-industry relationships, such as industry consulting or giving industry-sponsored talks, also adversely affected trust, though to a lesser extent than physician payment for subject participation in clinical trials. Results of this study demonstrate that physician payment for study participation in multiple sclerosis clinical trials is a potential conflict that can adversely affect patient trust. Copyright © 2016 Elsevier B.V. All rights reserved.

PPB | What is a Clinical Study

Cancer.gov

The Pleuropulmonary blastoma (PPB) DICER1 Syndrome Study ‹an observational clinical research study‹is enrolling children with PPB and their families. In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.

The Translational Role of Diffusion Tensor Image Analysis in Animal Models of Developmental Pathologies

PubMed Central

Oguz, Ipek; McMurray, Matthew S.; Styner, Martin; Johns, Josephine M.

2013-01-01

Diffusion Tensor Magnetic Resonance Imaging (DTI) has proven itself a powerful technique for clinical investigation of the neurobiological targets and mechanisms underlying developmental pathologies. The success of DTI in clinical studies has demonstrated its great potential for understanding translational animal models of clinical disorders, and preclinical animal researchers are beginning to embrace this new technology to study developmental pathologies. In animal models, genetics can be effectively controlled, drugs consistently administered, subject compliance ensured, and image acquisition times dramatically increased to reduce between-subject variability and improve image quality. When pairing these strengths with the many positive attributes of DTI, such as the ability to investigate microstructural brain organization and connectivity, it becomes possible to delve deeper into the study of both normal and abnormal development. The purpose of this review is to provide new preclinical investigators with an introductory source of information about the analysis of data resulting from small animal DTI studies to facilitate the translation of these studies to clinical data. In addition to an in depth review of translational analysis techniques, we present a number of relevant clinical and animal studies using DTI to investigate developmental insults in order to further illustrate techniques and to highlight where small animal DTI could potentially provide a wealth of translational data to inform clinical researchers. PMID:22627095

Collaborative Approach in the Development of High‐Performance Brain–Computer Interfaces for a Neuroprosthetic Arm: Translation from Animal Models to Human Control

PubMed Central

Collinger, Jennifer L.; Kryger, Michael A.; Barbara, Richard; Betler, Timothy; Bowsher, Kristen; Brown, Elke H. P.; Clanton, Samuel T.; Degenhart, Alan D.; Foldes, Stephen T.; Gaunt, Robert A.; Gyulai, Ferenc E.; Harchick, Elizabeth A.; Harrington, Deborah; Helder, John B.; Hemmes, Timothy; Johannes, Matthew S.; Katyal, Kapil D.; Ling, Geoffrey S. F.; McMorland, Angus J. C.; Palko, Karina; Para, Matthew P.; Scheuermann, Janet; Schwartz, Andrew B.; Skidmore, Elizabeth R.; Solzbacher, Florian; Srikameswaran, Anita V.; Swanson, Dennis P.; Swetz, Scott; Tyler‐Kabara, Elizabeth C.; Velliste, Meel; Wang, Wei; Weber, Douglas J.; Wodlinger, Brian

2013-01-01

Abstract Our research group recently demonstrated that a person with tetraplegia could use a brain–computer interface (BCI) to control a sophisticated anthropomorphic robotic arm with skill and speed approaching that of an able‐bodied person. This multiyear study exemplifies important principles in translating research from foundational theory and animal experiments into a clinical study. We present a roadmap that may serve as an example for other areas of clinical device research as well as an update on study results. Prior to conducting a multiyear clinical trial, years of animal research preceded BCI testing in an epilepsy monitoring unit, and then in a short‐term (28 days) clinical investigation. Scientists and engineers developed the necessary robotic and surgical hardware, software environment, data analysis techniques, and training paradigms. Coordination among researchers, funding institutes, and regulatory bodies ensured that the study would provide valuable scientific information in a safe environment for the study participant. Finally, clinicians from neurosurgery, anesthesiology, physiatry, psychology, and occupational therapy all worked in a multidisciplinary team along with the other researchers to conduct a multiyear BCI clinical study. This teamwork and coordination can be used as a model for others attempting to translate basic science into real‐world clinical situations. PMID:24528900

[Multicenter randomized controlled clinical study on levornidazole and sodium chloride injection in the treatment of pelvic anaerobic infections].

PubMed

Ma, Ling; Zhang, Yuan-Zhen; Zheng, Yi-Lin; Wang, Ze-Hua; Xu, You-di; Kong, Li-Na

2010-10-01

to evaluate clinical efficacy and safety of levornidazole in the treatment of pelvic anaerobic infections. a multicenter randomized controlled clinical study was conducted to evaluate clinical efficacy and safety of levornidazole. One hundred and fourty-three patients with pelvic anaerobic bacteria infection were classified into 70 cases treated by levornidazole in study group and 73 cases treated by Ornidazole in control group. Those patients in two groups were both administered at a dose of 0.5 g twice daily for 5 - 7 days. The rate of clinical efficacy, bacteria clearance and adverse effect were recorded and compared between two groups. at the endpoint, the rate of clinical efficacy were 80% (56/70) in study group and 81% (59/73) in control group, which did not reach significant difference (P > 0.05). The rate of bacteria clearance were 97% (36/37) in study group and 92% (22/24) in control group, which also did not reach significant difference (P > 0.05). The rate of adverse reaction of 3% (20/70) in study group was significantly lower than 22% (16/73) in control group (P < 0.05). it is effective and safe to treat pelvic anaerobic infections with levornidazole and sodium chloride injection.

Is ginger beneficial for nausea and vomiting? An update of the literature.

PubMed

Marx, Wolfgang; Kiss, Nicole; Isenring, Liz

2015-06-01

Nausea and vomiting can pose a significant burden to patients in a variety of clinical settings. Previous evidence suggests that ginger may be an effective treatment for these symptoms; however, current evidence has been mixed. This article discusses recent clinical trials that have investigated ginger as a treatment for multiple types of nausea and vomiting. In addition, the potential mechanisms of action of ginger will be discussed. This article identified nine studies and seven reviews that investigated ginger for morning sickness, postoperative nausea and vomiting, chemotherapy-induced, and antiretroviral-induced nausea and vomiting. All studies reported that ginger provided a significant reduction in nausea and vomiting; however, the clinical relevance of some studies is less certain. Common limitations within the literature include the lack of standardized extracts, poorly controlled or blinded studies, and limited sample size. In addition, recent evidence has provided further support for 5-HT3 receptor antagonism as a mechanism by which ginger may exert its potentially beneficial effect on nausea and vomiting. The results of studies in this article suggest that ginger is a promising treatment for nausea and vomiting in a variety of clinical settings and possesses a clinically relevant mechanism. However, further studies are required to address the limitations in the current clinical literature before firm recommendations for its use can be made.

Hospitals’ Readiness for Clinical Governance Implementation in Educational Hospitals of Yazd, Iran

PubMed Central

Bahrami, Mohammad Amin; Sabahi, Ali Akbar; Montazeralfaraj, Razieh; Shamsi, Farimah; Ardekani, Samaneh Entezarian

2014-01-01

Background: Clinical governance is a systematic approach to maintaining and improving the quality of patient care. This study aimed to assess some Iranian educational hospitals’ readiness for clinical governance implementation through the organizational climate. Methods: It was a cross-sectional study that used the Clinical Governance Climate Questionnaire (CGCQ) in three educational hospitals in Yazd, a city in central Iran, in 2012. A total of 186 personnel contributed to the study. Data were analyzed using SPSS version 16. Descriptive statistics and the Kruskal-Wallis test were used for data analyses. Results: The mean scores of the clinical governance climate in Shahid Sadoughi, Shahid Rahnemoon and Afshar hospitals were 2.63±0.29, 2.58±0.32, and 2.68±0.29. The mean scores of quality improvement planning and change, quality improvement integration and motivation, clinical risk management and climate of blame and punishment, organizational learning, and training and development (T&D) opportunities for learning in the studied hospitals were 2.21±0.49, 2.80±0.40, 2.76±0.40, 2.91±0.54 and 3.06±0.72, respectively. Conclusion: The results of this study showed that the educational hospitals’ climate should be more supportive for successful implementation of clinical governance. PMID:25763148

Hospitals' readiness for clinical governance implementation in educational hospitals of yazd, iran.

PubMed

Bahrami, Mohammad Amin; Sabahi, Ali Akbar; Montazeralfaraj, Razieh; Shamsi, Farimah; Ardekani, Samaneh Entezarian

2014-01-01

Clinical governance is a systematic approach to maintaining and improving the quality of patient care. This study aimed to assess some Iranian educational hospitals' readiness for clinical governance implementation through the organizational climate. It was a cross-sectional study that used the Clinical Governance Climate Questionnaire (CGCQ) in three educational hospitals in Yazd, a city in central Iran, in 2012. A total of 186 personnel contributed to the study. Data were analyzed using SPSS version 16. Descriptive statistics and the Kruskal-Wallis test were used for data analyses. The mean scores of the clinical governance climate in Shahid Sadoughi, Shahid Rahnemoon and Afshar hospitals were 2.63±0.29, 2.58±0.32, and 2.68±0.29. The mean scores of quality improvement planning and change, quality improvement integration and motivation, clinical risk management and climate of blame and punishment, organizational learning, and training and development (T&D) opportunities for learning in the studied hospitals were 2.21±0.49, 2.80±0.40, 2.76±0.40, 2.91±0.54 and 3.06±0.72, respectively. The results of this study showed that the educational hospitals' climate should be more supportive for successful implementation of clinical governance.

Impact of Ischemic Preconditioning on Outcome in Clinical Liver Surgery: A Systematic Review

PubMed Central

Chu, Michael J. J.; Vather, Ryash; Hickey, Anthony J. R.; Phillips, Anthony R. J.; Bartlett, Adam S. J. R.

2015-01-01

Background. Ischemia-reperfusion injury is a major cause of post-liver-surgery complications. Ischemic preconditioning (IPC) has been demonstrated to protect against ischemia-reperfusion injury. Clinical studies have examined IPC in liver surgery but with conflicting results. This systematic review aimed to evaluate the effects of IPC on outcome in clinical liver surgery. Methods. An electronic search of OVID Medline and Embase databases was performed to identify studies that reported outcomes in patients undergoing liver surgery subjected to IPC. Basic descriptive statistics were used to summarise data from individual clinical studies. Results. 1093 articles were identified, of which 24 met the inclusion criteria. Seven topics were selected and analysed by subgroup. There were 10 studies in cadaveric liver transplantation, 2 in living-related liver transplantation, and 12 in liver resection. IPC decreases hepatocellular damage in liver surgery as determined by transaminases but does not translate to any significant clinical benefit in orthotopic liver transplant or liver resection. Conclusions. Available clinical evidence does not support routine use of IPC in liver surgery as it does not offer any apparent benefit in perioperative outcome. Further clinical studies will need to be carried out to determine the subset of patients that will benefit from IPC. PMID:25756045

Implementing clinical guidelines to prevent catheter-associated urinary tract infections and improve catheter care in nursing homes: Systematic review.

PubMed

Gould, Dinah; Gaze, Sarah; Drey, Nicholas; Cooper, Tracey

2017-05-01

Catheter-associated urinary tract infection is the most common health care-associated infection, is considered avoidable, and has cost implications for health services. Prevalence is high in nursing homes, but little research has been undertaken to establish whether implementing clinical guidelines can reduce infection rates in long-term care or improve quality of urinary catheter care. Systematic search and critical appraisal of the literature. Three studies evaluated the impact of implementing a complete clinical guideline. Five additional studies evaluated the impact of implementing individual elements of a clinical guideline. Prevention of catheter-associated urinary tract infection in nursing homes has received little clinical or research attention. Studies concerned with whole guideline implementation emerged as methodologically poor using recognized criteria for critically appraising epidemiologic studies concerned with infection prevention. Research evaluating the impact of single elements of clinical guidelines is more robust, and their findings could be implemented to prevent urinary infections in nursing homes. Copyright © 2017. Published by Elsevier Inc.

Curcuma as a functional food in the control of cancer and inflammation.

PubMed

Schaffer, Moshe; Schaffer, Pamela M; Zidan, Jamal; Bar Sela, Gil

2011-11-01

Several nutritional compounds are the focus of public attention because of their potential beneficial health effects. Turmeric is a spice that comes from the root Curcuma longa. Extensive research over the past half century and especially in recent years has revealed important functions of curcumin and a timely review of clinical state-of-the-art using curcumin. In-vitro and in-vivo research has shown various activities, such as anti-inflammatory, antiviral, antifungal, cytokines release, antioxidant, immunomodulatory, enhancing of the apoptotic process, and antiangiogenic properties. Curcumin also have been shown to be a mediator of chemo-resistance and radio-resistance. Various in-vitro and in-vivo and scarce number of clinical studies on curcumin were identified. The various effects and properties of curcumin are summarized in this review, including preclinical and especially clinical studies. This review concentrates on recent knowledge and research with curcumin clinical applications, and clinical studies, focusing on studies published between 2008 and 2011 demonstrating the gap between preclinical and clinical research.

Beyond the Dedicated Education Unit: Using Cognitive Load Theory to Guide Clinical Placement.

PubMed

Mulcock, Pamela McPhie; Grassley, Jane; Davis, Michael; White, Kathryn

2017-02-01

Navigating multiple instructors and clinical agencies can impair students' learning by increasing their cognitive load and perceived stress. This study used cognitive load theory to guide the home base clinical model (HBCM), which assigned students to the same faculty and hospital unit for two consecutive medical-surgical clinical courses. The study used a quasi-experimental three-group design to evaluate the effects of the HBCM on students' perceived stress, compared with groups who changed hospital or instructor. A 10-point visual analog scale measured students' perceived stress on nine clinical tasks. The study recruited 140 participants. Reductions in mean stress were greater for the HBCM groups than the other two groups. The study findings challenge the current practice of placing students with changing faculty and facilities. The HBCM demonstrates potential as an effective model for increasing students' ability to learn by decreasing their cognitive load and subsequent stress in their clinical placements. [J Nurs Educ. 2017;56(2):105-109.]. Copyright 2017, SLACK Incorporated.

Interpreting and Integrating Clinical and Anatomic Pathology Results.

PubMed

Ramaiah, Lila; Hinrichs, Mary Jane; Skuba, Elizabeth V; Iverson, William O; Ennulat, Daniela

2017-01-01

The continuing education course on integrating clinical and anatomical pathology data was designed to communicate the importance of using a weight of evidence approach to interpret safety findings in toxicology studies. This approach is necessary, as neither clinical nor anatomic pathology data can be relied upon in isolation to fully understand the relationship between study findings and the test article. Basic principles for correlating anatomic pathology and clinical pathology findings and for integrating these with other study end points were reviewed. To highlight these relationships, a series of case examples, presented jointly by a clinical pathologist and an anatomic pathologist, were used to illustrate the collaborative effort required between clinical and anatomical pathologists. In addition, the diagnostic utility of traditional liver biomarkers was discussed using results from a meta-analysis of rat hepatobiliary marker and histopathology data. This discussion also included examples of traditional and novel liver and renal biomarker data implementation in nonclinical toxicology studies to illustrate the relationship between discrete changes in biochemistry and tissue morphology.

Team building: electronic management-clinical translational research (eM-CTR) systems.

PubMed

Cecchetti, Alfred A; Parmanto, Bambang; Vecchio, Marcella L; Ahmad, Sjarif; Buch, Shama; Zgheib, Nathalie K; Groark, Stephen J; Vemuganti, Anupama; Romkes, Marjorie; Sciurba, Frank; Donahoe, Michael P; Branch, Robert A

2009-12-01

Classical drug exposure: response studies in clinical pharmacology represent the quintessential prototype for Bench to Bedside-Clinical Translational Research. A fundamental premise of this approach is for a multidisciplinary team of researchers to design and execute complex, in-depth mechanistic studies conducted in relatively small groups of subjects. The infrastructure support for this genre of clinical research is not well-handled by scaling down of infrastructure used for large Phase III clinical trials. We describe a novel, integrated strategy, whose focus is to support and manage a study using an Information Hub, Communication Hub, and Data Hub design. This design is illustrated by an application to a series of varied projects sponsored by Special Clinical Centers of Research in chronic obstructive pulmonary disease at the University of Pittsburgh. In contrast to classical informatics support, it is readily scalable to large studies. Our experience suggests the culture consequences of research group self-empowerment is not only economically efficient but transformative to the research process.

Membrane transporters in drug development

PubMed Central

2011-01-01

Membrane transporters can be major determinants of the pharmacokinetic, safety and efficacy profiles of drugs. This presents several key questions for drug development, including which transporters are clinically important in drug absorption and disposition, and which in vitro methods are suitable for studying drug interactions with these transporters. In addition, what criteria should trigger follow-up clinical studies, and which clinical studies should be conducted if needed. In this article, we provide the recommendations of the International Transporter Consortium on these issues, and present decision trees that are intended to help guide clinical studies on the currently recognized most important drug transporter interactions. The recommendations are generally intended to support clinical development and filing of a new drug application. Overall, it is advised that the timing of transporter investigations should be driven by efficacy, safety and clinical trial enrolment questions (for example, exclusion and inclusion criteria), as well as a need for further understanding of the absorption, distribution, metabolism and excretion properties of the drug molecule, and information required for drug labeling. PMID:20190787

Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms

PubMed Central

Gamon, Carla; Späth, Christina; Berger, Thomas; Meyer, Björn; Hohagen, Fritz; Hautzinger, Martin; Lutz, Wolfgang; Vettorazzi, Eik; Moritz, Steffen; Schröder, Johanna

2017-01-01

Objective This study aims to examine whether the effects of internet interventions for depression generalise to participants recruited in clinical settings. Design This study uses subgroup analysis of the results of a randomised, controlled, single-blind trial. Setting The study takes place in five diagnostic centres in Germany. Participants A total of 1013 people with mild to moderate depressive symptoms were recruited from clinical sources as well as internet forums, statutory insurance companies and other sources. Interventions This study uses either care-as-usual alone (control) or a 12-week internet intervention (Deprexis) plus usual care (intervention). Main outcome measures The primary outcome measure was self-rated depression severity (Patient Health Questionnaire-9) at 3 months and 6 months. Further measures ranged from demographic and clinical parameters to a measure of attitudes towards internet interventions (Attitudes towards Psychological Online Interventions Questionnaire). Results The recruitment source was only associated with very few of the examined demographic and clinical characteristics. Compared with participants recruited from clinical sources, participants recruited through insurance companies were more likely to be employed. Clinically recruited participants were as severely affected as those from other recruitment sources but more sceptical of internet interventions. The effectiveness of the intervention was not differentially associated with recruitment source (treatment by recruitment source interaction=0.28, p=0.84). Conclusion Our results support the hypothesis that the intervention we studied is effective across different recruitment sources including clinical settings. Trial registration number ClinicalTrials.gov NCT01636752. PMID:28710212

The nature of placebo response in clinical studies of major depressive disorder.

PubMed

Papakostas, George I; Østergaard, Søren D; Iovieno, Nadia

2015-04-01

To review factors influencing placebo response and clinical trial outcome in depression, and suggest ways to optimize trial success in mood disorders. PubMed searches were conducted by cross-referencing the terms depression, depressive with placebo, clinical trial, and clinical trials for studies published in English between 1970 and September 2013. Relevant abstracts were identified in PubMed, including clinical trials, quantitative studies, and qualitative research. We obtained and reviewed relevant articles and utilized their information to synthesize the present review. Included articles were grouped in the following areas of relevance: (1) biological validity of illness, (2) baseline severity of illness, (3) chronicity of the index episode of depression, (4) age of participants, (5) medical and psychiatric comorbidity, (6) probability of receiving placebo, (7) use of prospective treatment phases (lead-in) (8) dosing schedule, (9) trial duration, (10) frequency of follow-up assessments, and (11) study outcome measure. Several key elements emerge as critical to the ultimate success of a clinical trial, including the probability of receiving placebo, study duration, dosing schedule, visit frequency, the use of blinded lead-in phases, the use of centralized raters, illness severity and duration, and comorbid anxiety. Our increasing understanding of the placebo response in clinical trials of major depressive disorder lends to a, gradually, more predictable phenomenon and, hopefully, to one that becomes lesser in magnitude and variability. Several elements have emerged that seem to play a critical role in trial success, gradually reshaping the design of clinical, translational, as well as mechanistic studies in depression. © Copyright 2015 Physicians Postgraduate Press, Inc.

Clinical acceptability of metal-ceramic fixed partial dental prosthesis fabricated with direct metal laser sintering technique-5 year follow-up.

PubMed

Prabhu, Radhakrishnan; Prabhu, Geetha; Baskaran, Eswaran; Arumugam, Eswaran M

2016-01-01

In recent years, direct metal laser sintered (DMLS) metal-ceramic-based fixed partial denture prostheses have been used as an alternative to conventional metal-ceramic fixed partial denture prostheses. However, clinical studies for evaluating their long-term clinical survivability and acceptability are limited. The aim of this study was to assess the efficacy of metal-ceramic fixed dental prosthesis fabricated with DMLS technique, and its clinical acceptance on long-term clinical use. The study group consisted of 45 patients who were restored with posterior three-unit fixed partial denture prosthesis made using direct laser sintered metal-ceramic restorations. Patient recall and clinical examination of the restorations were done after 6months and every 12 months thereafter for the period of 60 months. Clinical examination for evaluation of longevity of restorations was done using modified Ryge criteria which included chipping of the veneered ceramic, connector failure occurring in the fixed partial denture prosthesis, discoloration at the marginal areas of the veneered ceramic, and marginal adaptation of the metal and ceramic of the fixed denture prosthesis. Periapical status was assessed using periodical radiographs during the study period. Survival analysis was made using the Kaplan-Meier method. None of the patients had failure of the connector of the fixed partial denture prostheses during the study period. Two exhibited biological changes which included periapical changes and proximal caries adjacent to the abutments. DMLS metal-ceramic fixed partial denture prosthesis had a survival rate of 95.5% and yielded promising results during the 5-year clinical study.

Evaluation of Diagnostic Values of Clinical Assessment in Determining the Maturation of Arteriovenous Fistulas for Satisfactory Hemodialysis.

PubMed

Salimi, Fereshteh; Shahabi, Shahab; Talebzadeh, Hamid; Keshavarzian, Amir; Pourfakharan, Mohammad; Safaei, Mansour

2017-01-01

Fistulas are the preferred permanent hemodialysis vascular access, but a significant obstacle to increasing their prevalence is the fistula's high "failure to mature" (FTM) rate. This study aimed to identify postoperative clinical characteristics that are predictive of fistula FTM. This descriptive cross-sectional study was performed on 80 end-stage renal disease patients who referred to Al Zahra Hospital, Isfahan, for brachiocephalic fistula placement. After 4 weeks, the clinical criteria (trill, firmness, vein length, and venous engorgement) examined and the fistulas situation divided to favorable or unfavorable by each criterion, and the results comprised with dialysis possibility. Data were analyzed with SPSS version 21. Diagnostic index for CLINICAL examination was calculated. Among the 80 cases, 25 (31.2%) female and 55 (68.8%) male were studied with the mean age of 51.9 (standard deviation = 17) year ranged between 18 and 86 years old. Sixty-two (77.5%) cases had successful hemodialysis. All four clinical assessments were significantly more acceptable in patients with successful dialysis ( P < 0.001). According to the results of our study, the accuracy of all physical assessments was above 70% and except vein length other criteria had a sensitivity and negative predictive value of 100%. In this study, firmness of vein has highest specificity and positive predictive value (83.9% and 64.3%, respectively). Results of our study showed that high sensitivity and relatively low specificity of the clinical criterion. It means that unfavorable results of each clinical criterion predict unfavorable dialysis. Clinical evaluation of a newly created fistula 4-6 weeks after surgery should be considered mandatory.

Analyzing the effectiveness of teaching and factors in clinical decision-making.

PubMed

Hsieh, Ming-Chen; Lee, Ming-Shinn; Chen, Tsung-Ying; Tsai, Tsuen-Chiuan; Pai, Yi-Fong; Sheu, Min-Muh

2017-01-01

The aim of this study is to prepare junior physicians, clinical education should focus on the teaching of clinical decision-making. This research is designed to explore teaching of clinical decision-making and to analyze the benefits of an "Analogy guide clinical decision-making" as a learning intervention for junior doctors. This study had a "quasi-experimental design" and was conducted in a medical center in eastern Taiwan. Participants and Program Description: Thirty junior doctors and three clinical teachers were involved in the study. The experimental group (15) received 1 h of instruction from the "Analogy guide for teaching clinical decision-making" every day for 3 months. Program Evaluation: A "Clinical decision-making self-evaluation form" was used as the assessment tool to evaluate participant learning efficiency before and after the teaching program. Semi-structured qualitative research interviews were also conducted. We found using the analogy guide for teaching clinical decision-making could help enhance junior doctors' self-confidence. Important factors influencing clinical decision-making included workload, decision-making, and past experience. Clinical teaching using the analogy guide for clinical decision-making may be a helpful tool for training and can contribute to a more comprehensive understanding of decision-making.

Sharing Patient-Generated Data in Clinical Practices: An Interview Study.

PubMed

Zhu, Haining; Colgan, Joanna; Reddy, Madhu; Choe, Eun Kyoung

2016-01-01

Patients are tracking and generating an increasingly large volume of personal health data outside the clinic due to an explosion of wearable sensing and mobile health (mHealth) apps. The potential usefulness of these data is enormous as they can provide good measures of everyday behavior and lifestyle. However, how we can fully leverage patient-generated data (PGD) and integrate them in clinical practice is less clear. In this interview study, we aim to understand how patients and clinicians currently share patient-generated data in clinical care practice. From the study, we identified technical, social, and organizational challenges in sharing and fully leveraging patient-generated data in clinical practices. Our findings can provide researchers potential avenues for enablers and barriers in sharing patient-generated data in clinical settings.

Experimental evaluation of clinical colon anastomotic leakage.

PubMed

Pommergaard, Hans-Christian

2014-03-01

Colorectal anastomotic leakage remains a frequent and serious complication in gastrointestinal surgery. Patient and procedure related risk factors for anastomotic leakage have been identified. However, the responsible pathophysiological mechanisms are still unknown. Among these, ischemia and insufficient surgical technique have been suggested to play a central role. Animal models are valuable means to evaluate pathophysiological mechanisms and may be used to test preventive measures aiming at reducing the risk of anastomotic leakage, such as external anastomotic coating. The aim of this thesis was to: Clarify the best suited animal to model clinical anastomotic leakage in humans; Create animal models mimicking anastomotic leakage in humans induced by insufficient surgical technique and tissue ischemia; Determine the best suited coating materials to prevent anastomotic leakage. This study is a systematic review using the databases MEDLINE and Rex. MEDLINE was searched up to October 2010 to identify studies on experimental animal models of clinical colon anastomotic leakage. From the Rex database, textbooks on surgical aspects as well as gastrointestinal physiology and anatomy of experimental animals were identified. The results indicated that the mouse and the pig are the best suited animals to evaluate clinical anastomotic leakage. However, the pig model is less validated and more costly to use compared with the mouse. Most frequently, rats are used as models. However, extreme interventions are needed to create clinical leakage in these animals. The knowledge from this study formed the basis for selecting the animal species most suited for the models in the next studies. STUDY 2: In this experimental study, technically insufficient colonic anastomoses were performed in 110 C57BL/6 mice. The number of sutures in the intervention group was reduced to produce a suitable leakage rate. Moreover, the analgesia and suture material were changed in order to optimize the model. In the final experiment, the four-suture anastomoses resulted in a 40% leakage rate in the intervention groups, whereas the eight-suture control anastomoses had a 0% leakage rate. Furthermore, the use of absorbable suture together with voluntarily ingested Temgesic in chocolate spread as analgesic regimen were feasible. This model may be used to test the leakage reducing potential of coating materials. STUDY 3: This experimental study used 53 C57BL/6 mice, in which sufficient eight-suture anastomoses were created. By using bipolar electro-cautery, blood supply was reduced in a stepwise manner to create anastomotic leakage as a result of ischemia. The study showed that reduced blood supply led to large bowel obstruction instead of clinical leakage. However, anastomotic breaking strength was reduced in the ischemic anastomoses. STUDY 4: In this systematic review MEDLINE, Embase and Cinahl were searched up to September 2011 to identify studies evaluating external coating of colonic anastomoses. Most studies were experimental, in which designs were not comparable and many results were contradictory. In a clinical study, a non-significant benefit of fibrin sealant was found. Based on the available clinical and experimental data it was concluded that the fibrin-based sealants, such as Tisseel and Tachosil, and polyethylene glycols may be beneficial. However, further experimental and clinical studies are needed before routine clinical use can be recommended. The studies in this thesis may be valuable for the experimental research field of clinical anastomotic leakage. The model of technical insufficiency has been improved and is now thoroughly validated. If used by researchers worldwide, comparison of results is possible. Pure ischemia/anoxia may be too simple an approach to create a clinical leakage model. Thus, future models could focus on multiple risk factors. Conclusively, large-scale clinical multicenter studies are needed to definitively evaluate whether coating of colorectal anastomoses may reduce the leakage rate.

Merging clinical chemistry biomarker data with a COPD database - building a clinical infrastructure for proteomic studies.

PubMed

Eriksson, Jonatan; Andersson, Simone; Appelqvist, Roger; Wieslander, Elisabet; Truedsson, Mikael; Bugge, May; Malm, Johan; Dahlbäck, Magnus; Andersson, Bo; Fehniger, Thomas E; Marko-Varga, György

2016-01-01

Data from biological samples and medical evaluations plays an essential part in clinical decision making. This data is equally important in clinical studies and it is critical to have an infrastructure that ensures that its quality is preserved throughout its entire lifetime. We are running a 5-year longitudinal clinical study, KOL-Örestad, with the objective to identify new COPD (Chronic Obstructive Pulmonary Disease) biomarkers in blood. In the study, clinical data and blood samples are collected from both private and public health-care institutions and stored at our research center in databases and biobanks, respectively. The blood is analyzed by Mass Spectrometry and the results from this analysis then linked to the clinical data. We built an infrastructure that allows us to efficiently collect and analyze the data. We chose to use REDCap as the EDC (Electronic Data Capture) tool for the study due to its short setup-time, ease of use, and flexibility. REDCap allows users to easily design data collection modules based on existing templates. In addition, it provides two functions that allow users to import batches of data; through a web API (Application Programming Interface) as well as by uploading CSV-files (Comma Separated Values). We created a software, DART (Data Rapid Translation), that translates our biomarker data into a format that fits REDCap's CSV-templates. In addition, DART is configurable to work with many other data formats as well. We use DART to import our clinical chemistry data to the REDCap database. We have shown that a powerful and internationally adopted EDC tool such as REDCap can be extended so that it can be used efficiently in proteomic studies. In our study, we accomplish this by using DART to translate our clinical chemistry data to a format that fits the templates of REDCap.

Economic Analyses in Squamous Cell Carcinoma of the Head and Neck: A Review of the Literature From a Clinical Perspective

DOE Office of Scientific and Technical Information (OSTI.GOV)

Souza, Jonas A. de, E-mail: jdesouza@medicine.bsd.uchicago.edu; Santana, Iuri A.; Castro, Gilberto de

The purpose of this review was to describe cost-effectiveness and cost analysis studies across treatment modalities for squamous cell carcinoma of the head and neck (SCCHN), while placing their results in context of the current clinical practice. We performed a literature search in PubMed for English-language studies addressing economic analyses of treatment modalities for SCCHN published from January 2000 to March 2013. We also performed an additional search for related studies published by the National Institute for Health and Clinical Excellence in the United Kingdom. Identified articles were classified into 3 clinical approaches (organ preservation, radiation therapy modalities, and chemotherapy regimens)more » and into 2 types of economic studies (cost analysis and cost-effectiveness/cost-utility studies). All cost estimates were normalized to US dollars, year 2013 values. Our search yielded 23 articles: 13 related to organ preservation approaches, 5 to radiation therapy modalities, and 5 to chemotherapy regimens. In general, studies analyzed different questions and modalities, making it difficult to reach a conclusion. Even when restricted to comparisons of modalities within the same clinical approach, studies often yielded conflicting findings. The heterogeneity across economic studies of SCCHN should be carefully understood in light of the modeling assumptions and limitations of each study and placed in context with relevant settings of clinical practices and study perspectives. Furthermore, the scarcity of comparative effectiveness and quality-of-life data poses unique challenges for conducting economic analyses for a resource-intensive disease, such as SCCHN, that requires a multimodal care. Future research is needed to better understand how to compare the costs and cost-effectiveness of different modalities for SCCHN.« less

Integrating Telehealth Technology into a Clinical Pharmacy Telephonic Diabetes Management Program

PubMed Central

Klug, Cindy; Bonin, Kerry; Bultemeier, Nanette; Rozenfeld, Yelena; Stuckman Vasquez, Rebecca; Johnson, Mark; Cherry, Julie Cheitlin

2011-01-01

Background Use of home monitoring technologies can enhance care coordination and improve clinical outcomes in patients with diabetes and other chronic diseases. This study was designed to explore the feasibility of incorporating a telehealth system into an existing telephonic diabetes management program utilizing clinical pharmacists. Methods This observational study was conducted at three Providence Medical Group primary care clinics. Adults with a diagnosis of diabetes and a recent hemoglobin A1c (HbA1c) >8% were referred by their primary care provider to participate in the study. Participants utilized the telehealth system developed by Intel Corporation and were followed by clinical pharmacists who provide telephonic diabetes management. The primary clinical outcome measure was change in mean HbA1c. Secondary outcomes included blood glucose levels, participant self-management knowledge, and the degree of participant engagement. Results Mean HbA1c level decreased by 1.3% at the study end (p = .001). Based on participant satisfaction surveys and qualitative responses, participants were satisfied with the telehealth system. Mean blood glucose values decreased significantly over the 16-week study period from 178 mg/dl [standard deviation (SD) 67] at week 1 to 163 mg/dl (SD 64) at week 16 (p = .0002). Participants entered the study with moderate to good knowledge about managing their diabetes based on three questions, and no statistically significant improvement in knowledge was found post-study. Conclusion Telehealth technology can be a positive adjunct to the primary care team in managing diabetes or other chronic conditions to improve clinical outcomes. PMID:22027325

Specialist antenatal clinics for women at high risk of preterm birth: a systematic review of qualitative and quantitative research.

PubMed

Malouf, Reem; Redshaw, Maggie

2017-02-02

Preterm birth (PTB) is the leading cause of perinatal morbidity and mortality. Women with previous prenatal loss are at higher risk of preterm birth. A specialist antenatal clinic is considered as one approach to improve maternity and pregnancy outcomes. A systematic review of quantitative, qualitative and mixed method studies conducted on women at high risk of preterm birth (PTB). The review primary outcomes were to report on the specialist antenatal clinics effect in preventing or reducing preterm birth, perinatal mortality and morbidity and women's perceptions and experiences of a specialist clinic whether compared or not compared with standard antenatal care. Other secondary maternal, infant and economic outcomes were also determined. A comprehensive search strategy was carried out in English within electronic databases as far back as 1980. The reviewers selected studies, assessed the quality, and extracted data independently. Results were summarized and tabulated. Eleven studies fully met the review inclusion criteria, ten were quantitative design studies and only one was a qualitative design study. No mixed method design study was included in the review. All were published after 1989, seven were conducted in the USA and four in the UK. Results from five good to low quality randomised controlled trials (RCTs), all conducted before 1990, did not illustrate the efficacy of the clinic in reducing preterm birth. Whereas results from more recent low quality cohort studies showed some positive neonatal outcomes. Themes from one good quality qualitative study reflected on the emotional and psychological need to reduce anxiety and stress of women referred to such a clinic. Women expressed their negative emotional responses at being labelled as high risk and positive responses to being assessed and treated in the clinic. Women also reported that their partners were struggling to cope emotionally. Findings from this review were mixed. Evidence from cohort studies indicated a specialist clinic may be a means of predicting or preventing preterm birth. Testing this in a randomised controlled trial is desirable, though may be hard to achieve due to the growing focus of such clinics on managing women at high risk of preterm birth. Ongoing research has to recognize women's experiences and perceptions of such a clinic. Further clarification of the optimal referral route and a clear and standardized management and cost economic evaluation plan are also required. Fathers support and experience of PTB clinics should also be included in further research.

Design Aspects of a Case-Control Clinical Investigation of the Effect of HIV on Oral and Gastrointestinal Soluble Innate Factors and Microbes

PubMed Central

Phelan, Joan A.; Abrams, William R.; Norman, Robert G.; Li, Yihong; Laverty, Maura; Corby, Patricia M.; Nembhard, Jason; Neri, Dinah; Barber, Cheryl A.; Aberg, Judith A.; Fisch, Gene S.; Poles, Michael A.; Malamud, Daniel

2014-01-01

Introduction The impaired host defense system in HIV infection impacts the oral and gastrointestinal microbiota and associated opportunistic infections. Antiretroviral treatment is predicted to partially restore host defenses and decrease the oral manifestation of HIV/AIDS. Well-designed longitudinal studies are needed to better understand the interactions of soluble host defense proteins with bacteria and virus in HIV/AIDS. “Crosstalk” was designed as a longitudinal study of host responses along the gastrointestinal (GI) tract and interactions between defense molecules and bacteria in HIV infection and subsequent therapy. Purpose The clinical core formed the infrastructure for the study of the interactions between the proteome, microbiome and innate immune system. The core recruited and retained study subjects, scheduled visits, obtained demographic and medical data, assessed oral health status, collected samples, and guided analysis of the hypotheses. This manuscript presents a well-designed clinical core that may serve as a model for studies that combine clinical and laboratory data. Methods Crosstalk was a case-control longitudinal clinical study an initial planned enrollment of 170 subjects. HIV+ antiretroviral naïve subjects were followed for 9 visits over 96 weeks and HIV uninfected subjects for 3 visits over 24 weeks. Clinical prevalence of oral mucosal lesions, dental caries and periodontal disease were assessed. Results During the study, 116 subjects (47 HIV+, 69 HIV-) were enrolled. Cohorts of HIV+ and HIV- were demographically similar except for a larger proportion of women in the HIV- group. The most prevalent oral mucosal lesions were oral candidiasis and hairy leukoplakia in the HIV+ group. Discussion The clinical core was essential to enable the links between clinical and laboratory data. The study aims to determine specific differences between oral and GI tissues that account for unique patterns of opportunistic infections and to delineate the differences in their susceptibility to infection by HIV and their responses post-HAART. PMID:25409430

Meta-analysis of Clinical and Radiographic Outcomes After Arthroscopic Single-Row Versus Double-Row Rotator Cuff Repair

PubMed Central

Perser, Karen; Godfrey, David; Bisson, Leslie

2011-01-01

Context: Double-row rotator cuff repair methods have improved biomechanical performance when compared with single-row repairs. Objective: To review clinical outcomes of single-row versus double-row rotator cuff repair with the hypothesis that double-row rotator cuff repair will result in better clinical and radiographic outcomes. Data Sources: Published literature from January 1980 to April 2010. Key terms included rotator cuff, prospective studies, outcomes, and suture techniques. Study Selection: The literature was systematically searched, and 5 level I and II studies were found comparing clinical outcomes of single-row and double-row rotator cuff repair. Coleman methodology scores were calculated for each article. Data Extraction: Meta-analysis was performed, with treatment effect between single row and double row for clinical outcomes and with odds ratios for radiographic results. The sample size necessary to detect a given difference in clinical outcome between the 2 methods was calculated. Results: Three level I studies had Coleman scores of 80, 74, and 81, and two level II studies had scores of 78 and 73. There were 156 patients with single-row repairs and 147 patients with double-row repairs, both with an average follow-up of 23 months (range, 12-40 months). Double-row repairs resulted in a greater treatment effect for each validated outcome measure in 4 studies, but the differences were not clinically or statistically significant (range, 0.4-2.2 points; 95% confidence interval, –0.19, 4.68 points). Double-row repairs had better radiographic results, but the differences were also not statistically significant (P = 0.13). Two studies had adequate power to detect a 10-point difference between repair methods using the Constant score, and 1 study had power to detect a 5-point difference using the UCLA (University of California, Los Angeles) score. Conclusions: Double-row rotator cuff repair does not show a statistically significant improvement in clinical outcome or radiographic healing with short-term follow-up. PMID:23016017

A Psychometric Study of the Fear of Sleep Inventory-Short Form (FoSI-SF)

PubMed Central

Pruiksma, Kristi E.; Taylor, Daniel J.; Ruggero, Camilo; Boals, Adriel; Davis, Joanne L.; Cranston, Christopher; DeViva, Jason C.; Zayfert, Claudia

2014-01-01

Study Objectives: Fear of sleep may play a significant role in sleep disturbances in individuals with posttraumatic stress disorder (PTSD). This report describes a psychometric study of the Fear of Sleep Inventory (FoSI), which was developed to measure this construct. Methods: The psychometric properties of the FoSI were examined in a non-clinical sample of 292 college students (Study I) and in a clinical sample of 67 trauma-exposed adults experiencing chronic nightmares (Study II). Data on the 23 items of the FoSI were subjected to exploratory factor analyses (EFA) to identify items uniquely assessing fear of sleep. Next, reliability and validity of a 13-item version of the FoSI was examined in both samples. Results: A 13-item Short-Form version (FoSI-SF) was identified as having a clear 2-factor structure with high internal consistency in both the non-clinical (α = 0.76–0.94) and clinical (α = 0.88-0.91) samples. Both studies demonstrated good convergent validity with measures of PTSD (0.48-0.61) and insomnia (0.39-0.48) and discriminant validity with a measure of sleep hygiene (0.19-0.27). The total score on the FoSI-SF was significantly higher in the clinical sample (mean = 17.90, SD = 12.56) than in the non-clinical sample (mean = 4.80, SD = 7.72); t357 = 8.85 p < 0.001. Conclusions: Although all items are recommended for clinical purposes, the data support the use of the 13-item FoSI-SF for research purposes. Replication of the factor structure in clinical samples is needed. Results are discussed in terms of limitations of this study and directions for further research. Citation: Pruiksma KE, Taylor DJ, Ruggero C, Boals A, Davis JL, Cranston C, DeViva JC, Zayfert C. A psychometric study of the Fear of Sleep Inventory-short form (FoSI-SF). J Clin Sleep Med 2014;10(5):551-558. PMID:24812541

Design aspects of a case-control clinical investigation of the effect of HIV on oral and gastrointestinal soluble innate factors and microbes.

PubMed

Phelan, Joan A; Abrams, William R; Norman, Robert G; Li, Yihong; Laverty, Maura; Corby, Patricia M; Nembhard, Jason; Neri, Dinah; Barber, Cheryl A; Aberg, Judith A; Fisch, Gene S; Poles, Michael A; Malamud, Daniel

2014-01-01

The impaired host defense system in HIV infection impacts the oral and gastrointestinal microbiota and associated opportunistic infections. Antiretroviral treatment is predicted to partially restore host defenses and decrease the oral manifestation of HIV/AIDS. Well-designed longitudinal studies are needed to better understand the interactions of soluble host defense proteins with bacteria and virus in HIV/AIDS. "Crosstalk" was designed as a longitudinal study of host responses along the gastrointestinal (GI) tract and interactions between defense molecules and bacteria in HIV infection and subsequent therapy. The clinical core formed the infrastructure for the study of the interactions between the proteome, microbiome and innate immune system. The core recruited and retained study subjects, scheduled visits, obtained demographic and medical data, assessed oral health status, collected samples, and guided analysis of the hypotheses. This manuscript presents a well-designed clinical core that may serve as a model for studies that combine clinical and laboratory data. Crosstalk was a case-control longitudinal clinical study an initial planned enrollment of 170 subjects. HIV+ antiretroviral naïve subjects were followed for 9 visits over 96 weeks and HIV uninfected subjects for 3 visits over 24 weeks. Clinical prevalence of oral mucosal lesions, dental caries and periodontal disease were assessed. During the study, 116 subjects (47 HIV+, 69 HIV-) were enrolled. Cohorts of HIV+ and HIV- were demographically similar except for a larger proportion of women in the HIV- group. The most prevalent oral mucosal lesions were oral candidiasis and hairy leukoplakia in the HIV+ group. The clinical core was essential to enable the links between clinical and laboratory data. The study aims to determine specific differences between oral and GI tissues that account for unique patterns of opportunistic infections and to delineate the differences in their susceptibility to infection by HIV and their responses post-HAART.

Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

PubMed

Sivaramakrishnan, Gowri; Sridharan, Kannan

2016-06-01

Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be laid down on the quality of trials being conducted in order to provide justice in the name of EBP. Copyright © 2016 Elsevier Inc. All rights reserved.

The Effects of Aerobic Exercise on the Recovery of Walking Ability and Neuroplasticity in People with Multiple Sclerosis: A Systematic Review of Animal and Clinical Studies

PubMed Central

2017-01-01

Introduction Walking is of high priority for people with multiple sclerosis (PwMS). It remains unclear whether aerobic exercise can improve walking ability and upregulate neurotrophins. This review aims to consolidate evidence to develop optimal aerobic training parameters to enhance walking outcomes and neuroplasticity in PwMS. Methods Clinical studies examining aerobic exercise for ≥3 weeks, having outcomes on walking with or without neurotrophic markers, were included. Studies utilizing animal models of MS were included if they employed aerobic exercise with outcomes on neurological recovery and neurotrophins. From a total of 1783 articles, 12 clinical and 5 animal studies were included. Results Eleven clinical studies reported improvements in walking ability. Only two clinical studies evaluated both walking and neurotrophins, and neither found an increase in neurotrophins despite improvements in walking. Patients with significant walking impairments were underrepresented. Long-term follow-up revealed mixed results. Two animal studies reported a positive change in both neurological recovery and neurotrophins. Conclusion Aerobic exercise improves walking ability in PwMS. Gains are not consistently maintained at 2- to 9-month follow-up. Studies examining levels of neurotrophins are inconclusive, necessitating further research. Aerobic exercise enhances both neurological recovery and neurotrophins in animal studies when started 2 weeks before induction of MS. PMID:29181199

The MAPP research network: design, patient characterization and operations.

PubMed

Landis, J Richard; Williams, David A; Lucia, M Scott; Clauw, Daniel J; Naliboff, Bruce D; Robinson, Nancy A; van Bokhoven, Adrie; Sutcliffe, Siobhan; Schaeffer, Anthony J; Rodriguez, Larissa V; Mayer, Emeran A; Lai, H Henry; Krieger, John N; Kreder, Karl J; Afari, Niloofar; Andriole, Gerald L; Bradley, Catherine S; Griffith, James W; Klumpp, David J; Hong, Barry A; Lutgendorf, Susan K; Buchwald, Dedra; Yang, Claire C; Mackey, Sean; Pontari, Michel A; Hanno, Philip; Kusek, John W; Mullins, Chris; Clemens, J Quentin

2014-08-01

The "Multidisciplinary Approach to the Study of Chronic Pelvic Pain" (MAPP) Research Network was established by the NIDDK to better understand the pathophysiology of urologic chronic pelvic pain syndromes (UCPPS), to inform future clinical trials and improve clinical care. The evolution, organization, and scientific scope of the MAPP Research Network, and the unique approach of the network's central study and common data elements are described. The primary scientific protocol for the Trans-MAPP Epidemiology/Phenotyping (EP) Study comprises a multi-site, longitudinal observational study, including bi-weekly internet-based symptom assessments, following a comprehensive in-clinic deep-phenotyping array of urological symptoms, non-urological symptoms and psychosocial factors to evaluate men and women with UCPPS. Healthy controls, matched on sex and age, as well as "positive" controls meeting the non-urologic associated syndromes (NUAS) criteria for one or more of the target conditions of Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS) or Irritable Bowel Syndrome (IBS), were also evaluated. Additional, complementary studies addressing diverse hypotheses are integrated into the Trans-MAPP EP Study to provide a systemic characterization of study participants, including biomarker discovery studies of infectious agents, quantitative sensory testing, and structural and resting state neuroimaging and functional neurobiology studies. A highly novel effort to develop and assess clinically relevant animal models of UCPPS was also undertaken to allow improved translation between clinical and mechanistic studies. Recruitment into the central study occurred at six Discovery Sites in the United States, resulting in a total of 1,039 enrolled participants, exceeding the original targets. The biospecimen collection rate at baseline visits reached nearly 100%, and 279 participants underwent common neuroimaging through a standardized protocol. An extended follow-up study for 161 of the UCPPS participants is ongoing. The MAPP Research Network represents a novel, comprehensive approach to the study of UCPPS, as well as other concomitant NUAS. Findings are expected to provide significant advances in understanding UCPPS pathophysiology that will ultimately inform future clinical trials and lead to improvements in patient care. Furthermore, the structure and methodologies developed by the MAPP Network provide the foundation upon which future studies of other urologic or non-urologic disorders can be based. ClinicalTrials.gov identifier: NCT01098279 "Chronic Pelvic Pain Study of Individuals with Diagnoses or Symptoms of Interstitial Cystitis and/or Chronic Prostatitis (MAPP-EP)". http://clinicaltrials.gov/show/NCT01098279.

Clinical Research Nursing: A Critical Resource in the National Research Enterprise

PubMed Central

Hastings, Clare E.; Fisher, Cheryl A.; McCabe, Margaret A.

2012-01-01

Translational clinical research has emerged as an important priority for the national research enterprise, with a clearly stated mandate to deliver prevention strategies, treatments and cures based on scientific innovations faster to the public. Within this national effort, a lack of consensus persists concerning the need for clinical nurses with expertise and specialized training in study implementation and the delivery of care to research participants. This paper reviews efforts to define and document the role of practicing nurses in implementing studies and coordinating clinical research in a variety of clinical settings and differentiates this clinical role from the role of nurses as scientists and principal investigators. We propose an agenda for building evidence that having nurses provide and coordinate study treatments and procedures can potentially improve research efficiency, participant safety, and the quality of research data. We also provide recommendations for the development of the emerging specialty of clinical research nursing. PMID:22172370

Synthesis maps: visual knowledge translation for the CanIMPACT clinical system and patient cancer journeys.

PubMed

Jones, P H; Shakdher, S; Singh, P

2017-04-01

Salient findings and interpretations from the canimpact clinical cancer research study are visually represented in two synthesis maps for the purpose of communicating an integrated presentation of the study to clinical cancer researchers and policymakers. Synthesis maps integrate evidence and expertise into a visual narrative for knowledge translation and communication. A clinical system synthesis map represents the current Canadian primary care and cancer practice systems, proposed as a visual knowledge translation from the mixed-methods canimpact study to inform Canadian clinical research, policy, and practice discourses. Two synthesis maps, drawn together from multiple canimpact investigations and sources, were required to articulate critical differences between the clinical system and patient perspectives. The synthesis map of Canada-wide clinical cancer systems illustrates the relationships between primary care and the full cancer continuum. A patient-centred map was developed to represent the cancer (and primary care) journeys as experienced by breast and colorectal cancer patients.

The Relationship Between Levels of Fidelity in Simulation, Traditional Clinical Experiences and Objectives.

PubMed

Gore, Teresa

2017-06-15

The purpose of this study was to explore the relationship of baccalaureate nursing students' (BSN) perceived learning effectiveness using the Clinical Learning Environments Comparison Survey of different levels of fidelity simulation and traditional clinical experiences. A convenience sample of 103 first semester BSN enrolled in a fundamental/assessment clinical course and 155 fifth semester BSN enrolled in a leadership clinical course participated in this study. A descriptive correlational design was used for this cross-sectional study to evaluate students' perceptions after a simulation experience and the completion of the traditional clinical experiences. The subscales measured were communication, nursing leadership, and teaching-learning dyad. No statistical differences were noted based on the learning objectives. The communication subscale showed a tendency toward preference for traditional clinical experiences in meeting students perceived learning for communication. For student perceived learning effectiveness, faculty should determine the appropriate level of fidelity in simulation based on the learning objectives.

Challenges in Evaluating Clinical Governance Systems in Iran: A Qualitative Study

PubMed Central

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-01-01

Background: In spite of the pivotal role of clinical governance in enhancing quality of services provided by hospitals across the country, a scientific framework with specific criteria for evaluating hospitals has not been developed so far. Objectives: This study was conducted with the aim to identify the challenges involved in evaluating systems of clinical governance in Iran. Materials and Methods: For the purposes of this qualitative study, 15 semi-structured interviews with experts in the field were conducted in 2011 and the data were analyzed using framework analysis method. Results: Five major challenges in evaluating clinical governance include managing human resources, improving clinical quality, managing development, organizing clinical governance, and providing patient-oriented healthcare system. Conclusions: Healthcare system in Iran requires a clinical governance program which has a patient-oriented approach in philosophy, operation, and effectiveness in order to meet the challenges ahead. PMID:24910799

[Development of Autogenic Training Clinical Effectiveness Scale (ATCES)].

PubMed

Ikezuki, Makoto; Miyauchi, Yuko; Yamaguchi, Hajime; Koshikawa, Fusako

2002-02-01

The purpose of the present study was to develop a scale measuring clinical effectiveness of autogenic training. In Study 1, 167 undergraduates completed a survey of items concerning physical and mental states, which were thought to vary in the course of autogenic training. With item and factor analyses, 20 items were selected, and the resulting scale (ATCES) had high discrimination and clear factor structure. In Study 2, reliability and concurrent and clinical validity of the scale were examined with three groups of respondents: 85 mentally healthy, 31 control, 13 clinical persons. The scale showed a high test-retest correlation (r = .83) and alpha coefficient (alpha = .86). ATCES had a Pearson correlation coefficient of r = .56 with General Health Questionnaire (GHQ-12), and r = .73 with trait anxiety (STAI-T). And ATCES successfully discriminated the mentally healthy and clinical groups in terms of clinical effectiveness. These results demonstrated high reliability and sufficient concurrent and clinical validity of the new scale.

Clinical signs in the Wernicke-Korsakoff complex: a retrospective analysis of 131 cases diagnosed at necropsy.

PubMed Central

Harper, C G; Giles, M; Finlay-Jones, R

1986-01-01

A recent necropsy study has shown that 80% of patients with the Wernicke-Korsakoff syndrome were not diagnosed as such during life. Review of the clinical signs of these cases revealed that only 16% had the classical clinical triad and 19% had no documented clinical signs. The incidence of clinical signs in this and other retrospective pathological studies is very different from that of prospective clinical studies. This discrepancy may relate to "missed" clinical signs but the magnitude of the difference suggests that at least some cases of the Wernicke-Korsakoff syndrome may be the end result of repeated subclinical episodes of vitamin B1 deficiency. In order to make the diagnosis, clinicians must maintain a high index of suspicion in the "at risk" group of patients, particularly alcoholics. Investigations of thiamine status may be helpful and if the diagnosis is suspected, parenteral thiamine should be given. PMID:3701343

Use of technology for note taking and therapeutic alliance.

PubMed

Wiarda, Nicholas R; McMinn, Mark R; Peterson, Mary A; Gregor, Joel A

2014-09-01

Is psychotherapeutic alliance helped or harmed by using an iPad or computer during an intake session? Two studies are reported where psychotherapists use one of three different technologies in semistructured initial interviews: paper and pen, iPad, or a computer. The studies were conducted at a Primary Care Clinic and a Community Mental Health Clinic to provide a broader context to account for recent behavioral health integration into medical settings in addition to a traditional psychotherapy setting. The Primary Care Study consisted of 60 participants from a behavioral health service at a primary care clinic. The Community Mental Health Study involved 55 participants from a community mental health clinic in semirural Oregon. No differences were found for the three technologies in either study. Practice and training implications are offered. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Assessing the extent to which current clinical research is consistent with patient priorities: a scoping review using a case study in patients on or nearing dialysis.

PubMed

Jun, Min; Manns, Braden; Laupacis, Andreas; Manns, Liam; Rehal, Bhavdeep; Crowe, Sally; Hemmelgarn, Brenda R

2015-01-01

There is growing acknowledgement that engaging patients to identify their research priorities is important. Using a case study of patients on or nearing dialysis, we sought to assess the extent to which recently completed and ongoing clinical research was consistent with priorities identified by patients, caregivers, and clinicians. Over a 4-year sampling frame (January 2010 to December 2013), we systematically searched the medical literature (top 5 nephrology and top 10 general medicine journals accessed through MEDLINE via Ovid), international randomized controlled trial (RCT) registries, and national government and kidney research funding organizations (Canada, U.S., Australia, and U.K.) for published clinical studies, registered RCTs, and funded clinical studies, respectively. Published clinical studies, registered RCTs, and funded clinical studies were categorized as to whether or not they were consistent with the top 10 research priorities identified by patients, their caregivers, and clinicians in a recent comprehensive research priority setting exercise. The search yielded 4293 published articles, 688 RCTs, and 70 funded studies, of which 1116 articles, 315 RCTs, and 70 funded studies were eligible for inclusion. Overall 194 published studies (17.4 %), 71 RCTs (22.5 %), and 15 funded studies (21.4 %) included topics consistent with the top 10 research priorities identified by patients. Four of the top 10 research priorities, including strategies to improve the management of itching, increase access to kidney transplantation, assess the psychosocial impact of kidney failure, and determine the effects of dietary restriction received virtually no attention. The top 10 priorities we used to categorize included studies were identified by Canadian patients, caregivers, and clinicians. The top research priorities may vary across different countries. The proportion of published studies that are consistent with the top 10 priorities could be different in nephrology journals with lower impact factors. Studies related to kidney transplantation and the psychosocial impact of kidney failure may have been published in journals not included in our search strategy. The majority of recently completed or ongoing clinical studies in patients on or nearing dialysis do not address the top research priorities of patients, raising concerns that current clinical research may not be meeting the needs of the ultimate consumer, in this case, patients on or nearing dialysis. Greater involvement of patients in research is required to bridge the gap between research and patients' needs.

Economic evaluations of clinical pharmacy services: 2006-2010.

PubMed

Touchette, Daniel R; Doloresco, Fred; Suda, Katie J; Perez, Alexandra; Turner, Stuart; Jalundhwala, Yash; Tangonan, Maria C; Hoffman, James M

2014-08-01

Studies have consistently evidenced the positive clinical, economic, and humanistic benefits of pharmacist-directed patient care in a variety of settings. Given the vast differences in clinical outcomes associated with evaluated clinical pharmacy services (CPS), more detail as to the nature of the CPS is needed to better understand observed differences in economic outcomes. With the growing trend of outpatient pharmacy services, these economic evaluations serve as viable decision-making tools in choosing the most effective and cost-effective pharmacy programs. We previously conducted three systematic reviews to evaluate the economic impact of CPS from 1988 to 2005. In this systematic review, our objectives were to describe and evaluate the quality of economic evaluations of CPS published between 2006 and 2010, with the goal of informing administrators and practitioners as to their cost-effectiveness. We searched the scientific literature by using the Medline, International Pharmaceutical Abstracts, Embase, and Cumulative Index to Nursing and Allied Health Literature databases to identify studies describing CPS published from 2006 to 2010. Studies meeting our inclusion criteria (original research articles that evaluated CPS and described economic and clinical outcomes) were reviewed by two investigators. Methodology used, economic evaluation type, CPS setting and type, and clinical and economic outcome results were extracted. Results were informally compared with previous systematic reviews. Of 3587 potential studies identified, 25 met inclusion criteria. Common CPS settings were hospital (36%), community (32%), and clinic or hospital-based ambulatory practices (28%). CPS types were disease state management (48%), general pharmacotherapeutic monitoring (24%), target drug programs (8%), and patient education (4%). Two studies (8%) listed CPS as medication therapy management. Costs were evaluated in 24 studies (96%) and sufficiently described in 13 (52%). Clinical or humanistic outcomes were evaluated in 20 studies (80%) and were sufficiently described in 18 (72%). Control groups were included in 16 (70%) of 23 studies not involving modeling. Study assumptions and limitations were stated and justified in eight studies (32%). Conclusions and recommendations were considered justified and based on results in 24 studies (96%). Eighteen studies (72%) involved full economic evaluation. The mean ± SD study quality score for full economic evaluations (18 studies) was 60.4 ± 22.3 of a possible 100 points. Benefit-cost ratios from three studies ranged from 1.05:1 to 25.95:1, and incremental cost-effectiveness ratios of five studies were calculated and reported. Fewer studies documented the economic impact of CPS from 2006-2010 than from 2001-2005, although a higher proportion involved controlled designs and were full economic evaluations. Evaluations of ambulatory practices were increasingly common. CPS were generally considered cost-effective or provided a good benefit-cost ratio. © 2014 Pharmacotherapy Publications, Inc.

Internalized Stigma of Mental Illness among Schizophrenic Patients and Their Families (Comparative Study)

ERIC Educational Resources Information Center

Mahmoud, Sahar; Zaki, Rania A.

2015-01-01

This study was a comparative study aiming to assess the extent of internalized stigma of mental illness among patients with schizophrenia & identify stigma as perceived by family members caring schizophrenic patients. The study was conducted in two settings 1st clinic was outpatient clinic for psychiatric patient affiliated to Abbasia…

The practical application of adaptive study design in early phase clinical trials: a retrospective analysis of time savings.

PubMed

Lorch, U; Berelowitz, K; Ozen, C; Naseem, A; Akuffo, E; Taubel, J

2012-05-01

The interest in adaptive study design is evident from the growing amount of clinical research employing this model in the mid to later stages of medicines development. Little has been published on the practical application and merits of adaptive study design in early phase clinical research. This paper describes a retrospective analysis performed on a sample of 29 industry lead adaptive early phase studies commencing between 1 January 2006 and 31 December 2010 in a clinical trials unit in London, England. All studies containing at least one adaptive feature in the original protocol were included in the analysis. The scope of the analysis was to assess whether the use of adaptive study designs provided tangible benefits over the use of conventional study designs using time savings as the main measure. We conclude that the use of adaptive study design saves time in early phase research programs. This is achieved by abolishing the need for substantial amendments or by mitigating their impact on timelines and by using adaptive scheduling efficiencies.

Registration practices for observational studies on ClinicalTrials.gov indicated low adherence.

PubMed

Boccia, Stefania; Rothman, Kenneth J; Panic, Nikola; Flacco, Maria Elena; Rosso, Annalisa; Pastorino, Roberta; Manzoli, Lamberto; La Vecchia, Carlo; Villari, Paolo; Boffetta, Paolo; Ricciardi, Walter; Ioannidis, John P A

2016-02-01

The study aims to assess the status of registration of observational studies. We identified studies on cancer research with prospective recruitment of participants that were registered from February 2000 to December 2011 in ClinicalTrials.gov. We recorded the dates of registration and start of recruitment, outcomes, and description of statistical method. We searched for publications corresponding to the registered studies through May 31, 2014. One thousand one hundred nine registered studies were eligible. Primary and secondary outcomes were reported in 809 (73.0%) and 464 (41.8%) of them. The date of registration preceded the month of the study start in 145 (13.8%) and coincided in 205 (19.5%). A total of 151 publications from 120 (10.8%) registered studies were identified. In 2 (33.3%) of the 6 publications where ClinicalTrials.gov reported that the study started recruitment after registration, and in 9 (50.0%) of 18 publications where ClinicalTrials.gov reported the same date for registration and start of recruitment, the articles showed that the study had actually started recruiting before registration. During the period reviewed, few observational studies have been registered. Registration usually occurred after the study started, and prespecification of outcomes and statistical analysis rarely occurred. Copyright © 2016 Elsevier Inc. All rights reserved.

Using Plant Clinic Registers to Assess the Quality of Diagnoses and Advice Given to Farmers: A Case Study from Uganda

ERIC Educational Resources Information Center

Danielsen, Solveig; Boa, Eric; Mafabi, Moses; Mutebi, Emmanuel; Reeder, Robert; Kabeere, Flavia; Karyeija, Robert

2013-01-01

Purpose: This study developed a framework for quality assessment of diagnoses and advice given at plant clinics. Design/methodology/approach: Clinic registers from five plant clinics in Uganda (2006-2010) were used to develop quality assessment protocols for diagnoses and advice given by plant doctors. Assessment of quality of diagnoses was based…

A breast cancer clinical registry in an Italian comprehensive cancer center: an instrument for descriptive, clinical, and experimental research.

PubMed

Baili, Paolo; Torresani, Michele; Agresti, Roberto; Rosito, Giuseppe; Daidone, Maria Grazia; Veneroni, Silvia; Cavallo, Ilaria; Funaro, Francesco; Giunco, Marco; Turco, Alberto; Amash, Hade; Scavo, Antonio; Minicozzi, Pamela; Bella, Francesca; Meneghini, Elisabetta; Sant, Milena

2015-01-01

In clinical research, many potentially useful variables are available via the routine activity of cancer center-based clinical registries (CCCR). We present the experience of the breast cancer clinical registry at Fondazione IRCCS "Istituto Nazionale dei Tumori" to give an example of how a CCCR can be planned, implemented, and used. Five criteria were taken into consideration while planning our CCCR: (a) available clinical and administrative databases ought to be exploited to the maximum extent; (b) open source software should be used; (c) a Web-based interface must be designed; (d) CCCR data must be compatible with population-based cancer registry data; (e) CCCR must be an open system, able to be connected with other data repositories. The amount of work needed for the implementation of a CCCR is inversely linked with the amount of available coded data: the fewer data are available in the input databases as coded variables, the more work will be necessary, for information technology staff, text mining analysis, and registrars (for collecting data from clinical records). A cancer registry in a comprehensive cancer center can be used for several research aspects, such as estimate of the number of cases needed for clinical studies, assessment of biobank specimens with specific characteristics, evaluation of clinical practice and adhesion to clinical guidelines, comparative studies between clinical and population sets of patients, studies on cancer prognosis, and studies on cancer survivorship.

Evaluating the financial impact of clinical trials in oncology: results from a pilot study from the Association of American Cancer Institutes/Northwestern University clinical trials costs and charges project.

PubMed

Bennett, C L; Stinson, T J; Vogel, V; Robertson, L; Leedy, D; O'Brien, P; Hobbs, J; Sutton, T; Ruckdeschel, J C; Chirikos, T N; Weiner, R S; Ramsey, M M; Wicha, M S

2000-08-01

Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P =.4) Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.

Characteristics of clients who access mobile compared to clinic HIV counselling and testing services: a matched study from Cape Town, South Africa.

PubMed

Meehan, Sue-Ann; Naidoo, Pren; Claassens, Mareli M; Lombard, Carl; Beyers, Nulda

2014-12-20

Studies within sub-Saharan African countries have shown that mobile services increase uptake of HIV counselling and testing (HCT) services when compared to clinics and are able to access different populations, but these have included provider-initiated HCT in clinics. This study aimed to compare the characteristics of clients who self-initiated HCT at either a mobile or a clinic service in terms of demographic and socio-economic variables, also comparing reasons for accessing a particular health service provider. This study took place in eight areas around Cape Town. A matched design was used with one mobile HCT service matched with one or more clinics (offering routine HCT services) within each of the eight areas. Adult clients who self-referred for an HIV test within a specified time period at either a mobile or clinic service were invited to participate in the study. Data were collected between February and April 2011 using a questionnaire. Summary statistics were calculated for each service type within a matched pair and differences of outcomes from pairs were used to calculate effect sizes and 95% confidence intervals. 1063 participants enrolled in the study with 511 from mobile and 552 from clinic HCT services. The proportion of males accessing mobile HCT significantly exceeded that of clinic HCT (p < 0.001). The mean age of participants attending mobile HCT was higher than clinic participants (p = 0.023). No significant difference was found for socio-economic variables between participants, with the exception of access to own piped water (p = 0.029). Participants who accessed mobile HCT were significantly more likely to report that they were just passing, deemed an "opportunistic" visit (p = 0.014). Participants who accessed clinics were significantly more likely to report the service being close to home or work (p = 0.035). An HCT strategy incorporating a mobile HCT service, has a definite role to play in reaching those population groups who do not typically access HCT services at a clinic, especially males and those who take advantage of the opportunity to test. Mobile HCT services can complement clinic services.

The impact of outpatient clinical teaching on students' academic performance in obstetrics and gynecology.

PubMed

Hassan, Bahaeldin A; Elfaki, Omer A; Khan, Muhammed A

2017-01-01

Clinical teaching at outpatient settings is an essential part of undergraduate medical students' training. The increasing number of students in many medical schools and short hospital stays makes inpatient teaching alone insufficient to provide students with the required clinical skills. To make up this shortfall, outpatient clinical teaching has been implemented by our Department of Obstetrics and Gynecology, King Khalid University, KSA, throughout the academic year 2015-2016. The aim of this study was to evaluate the impact of clinical teaching at outpatient settings on the academic performance of our students. In this comparative retrospective study, the effects of outpatient clinical teaching of obstetrics and gynecology on the academic performance of student was assessed through an objective structured clinical examination (OSCE). During their course on obstetrics and gynecology, 58 students had their clinical teaching both at inpatient and outpatient settings and constituted "study group". The remaining 52 students had clinical teaching only at inpatient settings and were considered "control group". Students in both groups sat for OSCE at the end of week 8 of the gynecology course. Students in both groups sat for OSCE at the end of week 8 of the gynecology course. Four stations were used for assessment: obstetric history, gynecological history, obstetric physical examination of pregnant women, and gynecological procedure station. Twenty marks were allocated for each station giving a total score of 80. The OSCE scores for study group were compared with those of the control group using Student's t -test; p < 0.05 was considered statistically significant. The total mean OSCE score was statistically significantly higher in the study group (62.36 vs. 47.94, p < 0.001). The study group participants showed significantly higher scores in the gynecological procedure station (16.74 vs. 11.62, p < 0.0001) and obstetric examination station (16.72 vs. 10.79, p < 0.0001). Clinical teaching at outpatient settings leads to an improvement in students' performance in OSCE. There is evidence of remarkable improvement in the mastery of clinical skills as manifested in the students' scores in physical examination and procedures stations. These results will encourage us to have clinical teaching in other disciplines at outpatient settings.

Professional behaviors, sense of belonging, and professional socialization of early career clinical laboratory scientists

NASA Astrophysics Data System (ADS)

Schill, Janna Marie

Professional socialization is a process that individuals experience as members of a profession and consists of the knowledge, attitudes, and experiences that influence and shape their professional identity. The process of professional socialization has not been studied in the clinical laboratory science profession. Clinical laboratory science is an allied health profession that is faced by a workforce shortage that has been caused by a decrease in new graduates, decreased retention of qualified professionals, and increased retirements. Other allied health professions such as nursing, athletic training, and pharmacy have studied professional socialization as a way to identify factors that may influence the retention of early career professionals. This mixed method study, which quantitatively used Hall's Professionalism Scale (1968) in addition to qualitative focus group interviews, sought to identify the professional attitudes and behaviors, sense of belonging, and professional socialization of early career clinical laboratory scientists. Early career clinical laboratory scientists were divided into two groups based upon the amount of work experience they had; new clinical laboratory science graduates have had less than one year of work experience and novice clinical laboratory scientists had between one and three years of work experience. This study found that early career clinical laboratory scientists have established professional identities and view themselves as members of the clinical laboratory science field within four proposed stages of professional socialization consisting of pre-arrival, encounter, adaptation, and commitment. New CLS graduates and novice clinical laboratory scientists were found to be at different stages of the professional stage process. New CLS graduates, who had less than one year of work experience, were found to be in the encounter stage. Novice clinical laboratory scientists, with one to three years of work experience, were found to be in the adaptation stage. In order for early career clinical laboratory scientists to successfully transition from student to committed professional, increased support from more experienced colleagues needs to be provided for this group of laboratory professionals. This study provided an initial examination of the professional socialization process in the CLS profession and adds to existing professional socialization studies in allied health.

An evaluation of multimedia and online support groups (OSG) contents and application of information by infertile patients: Mixed method study

NASA Astrophysics Data System (ADS)

Wiweko, Budi; Narasati, Shabrina; Agung, Prince Gusti; Zesario, Aulia; Wibawa, Yohanes Satrya; Maidarti, Mila; Harzif, Achmad Kemal; Pratama, Gita; Sumapradja, Kanadi; Muharam, Raden; Hestiantoro, Andon

2018-02-01

Background: The presence of Online Support Groups (OSG) is expected to empower patients with infertility, thus allowing patients to be the focus of healthcare services. This study will evaluate multimedia content, OSG, and utilization of information for decision-making by patients using infertility services. This study is a mixed method study conducted from January - June 2016 at Yasmin IVF Clinic, Dr. Cipto Mangunkusumo General Hospital; and SMART IVF Clinic, Jakarta. The subjects are patients with infertility who sought treatment at the clinics. Data was collected through a structured interview in the form of a questionnaire. Informed consent was obtained from all individual participants included in the study. All procedures that performed in studies were by the ethical standards of the institutional. The result from 72 respondents showed quantitative analysis did not reveal any association between multimedia and OSG information sources with patient knowledge regarding infertility management. However, qualitative analysis highlighted three issues: the information regarding infertility services in the available multimedia and the OSG; use of the available information by patients when deciding to use infertility services. The level of awareness of respondents on searching information regarding infertility on the clinic website is still limited. It happened because most of the patients in the clinic are unaware of clinic website existence which provided the infertility information. Therefore, the clinic website needs to be promoted so the usage of this website will increase in the future.

Clinical Research with Transcranial Direct Current Stimulation (tDCS): Challenges and Future Directions

PubMed Central

Brunoni, Andre Russowsky; Nitsche, Michael A.; Bolognini, Nadia; Bikson, Marom; Wagner, Tim; Merabet, Lotfi; Edwards, Dylan J.; Valero-Cabre, Antoni; Rotenberg, Alexander; Pascual-Leone, Alvaro; Ferrucci, Roberta; Priori, Alberto; Boggio, Paulo; Fregni, Felipe

2011-01-01

Background Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. In the past ten years, tDCS physiological mechanisms of action have been intensively investigated giving support for the investigation of its applications in clinical neuropsychiatry and rehabilitation. However, new methodological, ethical, and regulatory issues emerge when translating the findings of preclinical and phase I studies into phase II and III clinical studies. The aim of this comprehensive review is to discuss the key challenges of this process and possible methods to address them. Methods We convened a workgroup of researchers in the field to review, discuss and provide updates and key challenges of neuromodulation use for clinical research. Main Findings/Discussion We reviewed several basic and clinical studies in the field and identified potential limitations, taking into account the particularities of the technique. We review and discuss the findings into four topics: (i) mechanisms of action of tDCS, parameters of use and computer-based human brain modeling investigating electric current fields and magnitude induced by tDCS; (ii) methodological aspects related to the clinical research of tDCS as divided according to study phase (i.e., preclinical, phase I, phase II and phase III studies); (iii) ethical and regulatory concerns; (iv) future directions regarding novel approaches, novel devices, and future studies involving tDCS. Finally, we propose some alternative methods to facilitate clinical research on tDCS. PMID:22037126

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.

PubMed

Harris, Lyndsay N; Ismaila, Nofisat; McShane, Lisa M; Andre, Fabrice; Collyar, Deborah E; Gonzalez-Angulo, Ana M; Hammond, Elizabeth H; Kuderer, Nicole M; Liu, Minetta C; Mennel, Robert G; Van Poznak, Catherine; Bast, Robert C; Hayes, Daniel F

2016-04-01

To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer. A literature search and prospectively defined study selection sought systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations. The literature search identified 50 relevant studies. One randomized clinical trial and 18 prospective-retrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens. In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences. © 2016 by American Society of Clinical Oncology.

[Anthology of the first clinical studies with hypothalamic hormones: a story of successful international cooperation].

PubMed

Schally, Andrew V; Gual, Carlos

2002-01-01

Our early pioneering clinical trials in Mexico with natural and synthetic thyrotropin-releasing hormone (TRH) and luteinizing hormone releasing hormone (LH-RH) also known as gonadotropin releasing hormone (Gn-RH), were reviewed. Highly purified TRH of porcine origin was shown to stimulate Thyrotropin (TSH) release in hypothyroid cretins. Subsequent tests with synthetic TRH also demonstrated significant increases in plasma TSH in normal men and women as well as in patients with primary hypothyroidism and other endocrine disorders. Even more extensive clinical studies were carried out with highly purified natural porcine LH-RH. Subjects with normal basal serum levels of gonadotropins, low levels (men and women pretreated with steroids) and high levels (e.g. post menopausal women) all responded to LH-RH with a release of LH and FSH. The results of these early studies with the natural LH-RH were confirmed by the use of synthetic LH-RH. These investigations made in Mexico with TRH and LH-RH preceded all other clinical studies by a wide margin. Subsequently various clinical investigations with LH-RH agonists and antagonists were also carried out. All these studies played a major role in introducing hypothalamic-releasing hormones into clinical medicine.

An exploration of clinical decision making in mental health triage.

PubMed

Sands, Natisha

2009-08-01

Mental health (MH) triage is a specialist area of clinical nursing practice that involves complex decision making. The discussion in this article draws on the findings of a Ph.D. study that involved a statewide investigation of the scope of MH triage nursing practice in Victoria, Australia. Although the original Ph.D. study investigated a number of core practices in MH triage, the focus of the discussion in this article is specifically on the findings related to clinical decision making in MH triage, which have not previously been published. The study employed an exploratory descriptive research design that used mixed data collection methods including a survey questionnaire (n = 139) and semistructured interviews (n = 21). The study findings related to decision making revealed a lack of empirically tested evidence-based decision-making frameworks currently in use to support MH triage nursing practice. MH triage clinicians in Australia rely heavily on clinical experience to underpin decision making and have little of knowledge of theoretical models for practice, such as methodologies for rating urgency. A key recommendation arising from the study is the need to develop evidence-based decision-making frameworks such as clinical guidelines to inform and support MH triage clinical decision making.

Consent for participating in clinical trials - Is it really informed?

PubMed

Alexa-Stratulat, Teodora; Neagu, Marius; Neagu, Anca-Iulia; Alexa, Ioana Dana; Ioan, Beatrice Gabriela

2018-06-22

The article explores the challenges of ensuring voluntary and informed consent which is obtained from potential research subjects in the north-eastern part of Romania. This study is one of the first empirical papers of this nature in Romania. The study used a quantitative survey design using the adapted Quality of Informed Consent (QuIC) questionnaire. The target population consisted of 100 adult persons who voluntarily enrolled in clinical trials. The informed consent form must contain details regarding the potential risks and benefits, the aim of the clinical trial, study design, confidentiality, insurance and contact details in case of additional questions. Our study confirmed that although all required information was included in the ICF, few clinical trial participants truly understood it. We also found that the most important predictive factor for a good subjective and objective understanding of the clinical trial was the level of education. Our study suggests that researchers should consider putting more effort in order to help clinical trials participants achieve a better understanding of the informed consent. In this way they will ensure that participants' decision-making is meaningful and that their interests are protected. © 2018 John Wiley & Sons Ltd.

Graduate admissions in clinical neuropsychology: the importance of undergraduate training.

PubMed

Karazsia, Bryan T; Stavnezer, Amy Jo; Reeves, Jonathan W

2013-11-01

Discussions of and recommendations for the training of clinical neuropsychologists exist at the doctoral, internship, and post-doctoral level. With few exceptions, the literature on undergraduate preparations in clinical neuropsychology is sparse and lacks empirical evidence. In the present study, graduate-level faculty and current trainees completed surveys about graduate school preparations. Faculty expectations of minimum and ideal undergraduate training were highest for research methods, statistics, and assessment. Preferences for "goodness of fit" also emerged as important admissions factors. These results offer evidence for desirable undergraduate preparations for advanced study in clinical neuropsychology. Although undergraduate training in psychology is intentionally broad, results from this study suggest that students who desire advanced study in clinical neuropsychology need to tailor their experiences to be competitive in the application process. The findings have implications for prospective graduate students, faculty who train and mentor undergraduates, and faculty who serve on admissions committees.

Clinical and Physiological Perspectives of β-Glucans: The Past, Present, and Future

PubMed Central

Bashir, Khawaja Muhammad Imran; Choi, Jae-Suk

2017-01-01

β-Glucans are a group of biologically-active fibers or polysaccharides from natural sources with proven medical significance. β-Glucans are known to have antitumor, anti-inflammatory, anti-obesity, anti-allergic, anti-osteoporotic, and immunomodulating activities. β-Glucans are natural bioactive compounds and can be taken orally, as a food supplement, or as part of a daily diet, and are considered safe to use. The medical significance and efficiency of β-glucans are confirmed in vitro, as well as using animal- and human-based clinical studies. However, systematic study on the clinical and physiological significance of β-glucans is scarce. In this review, we not only discuss the clinical and physiological importance of β-glucans, we also compare their biological activities through the existing in vitro and animal-based in vivo studies. This review provides extensive data on the clinical study of β-glucans. PMID:28872611

A systematic literature review of automated clinical coding and classification systems

PubMed Central

Williams, Margaret; Fenton, Susan H; Jenders, Robert A; Hersh, William R

2010-01-01

Clinical coding and classification processes transform natural language descriptions in clinical text into data that can subsequently be used for clinical care, research, and other purposes. This systematic literature review examined studies that evaluated all types of automated coding and classification systems to determine the performance of such systems. Studies indexed in Medline or other relevant databases prior to March 2009 were considered. The 113 studies included in this review show that automated tools exist for a variety of coding and classification purposes, focus on various healthcare specialties, and handle a wide variety of clinical document types. Automated coding and classification systems themselves are not generalizable, nor are the results of the studies evaluating them. Published research shows these systems hold promise, but these data must be considered in context, with performance relative to the complexity of the task and the desired outcome. PMID:20962126

A pilot study measuring changes in student impressions before and after clinical training using a questionnaire based on the semantic differential technique.

PubMed

Tamura, Naomi; Terashita, Takayoshi; Ogasawara, Katsuhiko

2013-01-01

Students with a positive impression of their studies can become more motivated. This study measured the learning impact of clinical training by comparing student impressions before and after clinical training. The study included 32 students of radiological technology in their final year with the Division of Radiological Science and Technology, Department of Health Sciences, School of Medicine, Hokkaido University. To measure student impressions of x-ray examination training, we developed a questionnaire using the semantic differential technique. The resulting factor analysis identified 2 factors that accounted for 44.9% of the 10 bipolar adjective scales. Factor 1 represented a "resistance" impression of x-ray examination training, and factor 2 represented a "responsibility" impression. The differences in factor scores before and after the clinical training suggest that student impressions are affected by clinical training.

Clinical Assessment and Diagnostics of Patients With Hand Disorders: A Case Study Approach.

PubMed

Leow, Mabel Qi He; Lim, Rebecca Qian Ru; Tay, Shian Chao

Clinical assessment of the hand is important for diagnosing underlying hand disorders. Using a case study approach, the clinical assessment for three disorders of the hands is presented: trigger finger (stenosing tenosynovitis), carpal tunnel syndrome, and ulnar-sided wrist injury (styloid impingement). We assess the annular one pulley and finger range of motion for patients with trigger finger. To diagnose for carpal tunnel syndrome, assessment for Tinel's sign, Phalen's sign, abductor pollicis brevis muscle bulk, two-point discrimination, and obtaining a nerve conduction study are performed. Assessment for ulnar-sided wrist injury includes wrist range of motion, assessment of distal radial ulnar joint stability, provocation tests, grip strength, x-ray, and magnetic resonance imaging. This article begins with a description of the hand and wrist anatomy. For each case study, the clinical history is described, followed by a discussion of the pathophysiology, clinical assessments, and diagnostic tests.

A systematic literature review of automated clinical coding and classification systems.

PubMed

Stanfill, Mary H; Williams, Margaret; Fenton, Susan H; Jenders, Robert A; Hersh, William R

2010-01-01

Clinical coding and classification processes transform natural language descriptions in clinical text into data that can subsequently be used for clinical care, research, and other purposes. This systematic literature review examined studies that evaluated all types of automated coding and classification systems to determine the performance of such systems. Studies indexed in Medline or other relevant databases prior to March 2009 were considered. The 113 studies included in this review show that automated tools exist for a variety of coding and classification purposes, focus on various healthcare specialties, and handle a wide variety of clinical document types. Automated coding and classification systems themselves are not generalizable, nor are the results of the studies evaluating them. Published research shows these systems hold promise, but these data must be considered in context, with performance relative to the complexity of the task and the desired outcome.

Motivational journey of Iranian bachelor of nursing students during clinical education: a grounded theory study.

PubMed

Hanifi, Nasrin; Parvizy, Soroor; Joolaee, Soodabeh

2013-09-01

This study explored how nursing students can be kept motivated throughout their clinical education. Motivation is a key issue in nursing clinical education for student retention. The study was conducted using grounded theory methods, which are appropriate when studying process in a social context. Sixteen students and four instructors, who were purposefully selected, participated in semistructured interviews. Data were analyzed using the constant comparative method. Students' motivational journey occurred in three steps: (i) social condition; (ii) encountering the clinical education challenges; and (iii) looking for an escape from nursing, or simply tolerating nursing. Struggling with professional identity emerged as the core variable. Iran's social context and many other conditions in the clinical education setting affect students' motivation. Identifying motivational process might assist educational authorities in offering solutions to promote motivation among students. © 2013 Wiley Publishing Asia Pty Ltd.

Image analysis of oronasal fistulas in cleft palate patients acquired with an intraoral camera.

PubMed

Murphy, Tania C; Willmot, Derrick R

2005-01-01

The aim of this study was to examine the clinical technique of using an intraoral camera to monitor the size of residual oronasal fistulas in cleft lip-cleft palate patients, to assess its repeatability on study casts and patients, and to compare its use with other methods. Seventeen plaster study casts of cleft palate patients with oronasal fistulas obtained from a 5-year series of 160 patients were used. For the clinical study, 13 patients presenting in a clinic prospectively over a 1-year period were imaged twice by the camera. The area of each fistula on each study cast was measured in the laboratory first using a previously described graph paper and caliper technique and second with the intraoral camera. Images were imported into a computer and subjected to image enhancement and area measurement. The camera was calibrated by imaging a standard periodontal probe within the fistula area. The measurements were repeated using a double-blind technique on randomly renumbered casts to assess the repeatability of measurement of the methods. The clinical images were randomly and blindly numbered and subjected to image enhancement and processing in the same way as for the study casts. Area measurements were computed. Statistical analysis of repeatability of measurement using a paired sample t test showed no significant difference between measurements, indicating a lack of systematic error. An intraclass correlation coefficient of 0.97 for the graph paper and 0.84 for the camera method showed acceptable random error between the repeated records for each of the two methods. The graph paper method remained slightly more repeatable. The mean fistula area of the study casts between each method was not statistically different when compared with a paired samples t test (p = 0.08). The methods were compared using the limits of agreement technique, which showed clinically acceptable repeatability. The clinical study of repeated measures showed no systematic differences when subjected to a t test (p = 0.109) and little random error with an intraclass correlation coefficient of 0.98. The fistula size seen in the clinical study ranged from 18.54 to 271.55 mm. Direct measurements subsequently taken on 13 patients in the clinic without study models showed a wide variation in the size of residual fistulas presenting in a multidisciplinary clinic. It was concluded that an intraoral camera method could be used in place of the previous graph paper method and could be developed for clinical and scientific purposes. This technique may offer advantages over the graph paper method, as it facilitates easy visualization of oronasal fistulas and objective fistulas size determination and permits easy storage of data in clinical records.

Guidance from an NIH Workshop on Designing, Implementing, and Reporting Clinical Studies of Soy Interventions1–4

PubMed Central

Klein, Marguerite A.; Nahin, Richard L.; Messina, Mark J.; Rader, Jeanne I.; Thompson, Lilian U.; Badger, Thomas M.; Dwyer, Johanna T.; Kim, Young S.; Pontzer, Carol H.; Starke-Reed, Pamela E.; Weaver, Connie M.

2010-01-01

The NIH sponsored a scientific workshop, “Soy Protein/Isoflavone Research: Challenges in Designing and Evaluating Intervention Studies,” July 28–29, 2009. The workshop goal was to provide guidance for the next generation of soy protein/isoflavone human research. Session topics included population exposure to soy; the variability of the human response to soy; product composition; methods, tools, and resources available to estimate exposure and protocol adherence; and analytical methods to assess soy in foods and supplements and analytes in biologic fluids and other tissues. The intent of the workshop was to address the quality of soy studies, not the efficacy or safety of soy. Prior NIH workshops and an evidence-based review questioned the quality of data from human soy studies. If clinical studies are pursued, investigators need to ensure that the experimental designs are optimal and the studies properly executed. The workshop participants identified methodological issues that may confound study results and interpretation. Scientifically sound and useful options for dealing with these issues were discussed. The resulting guidance is presented in this document with a brief rationale. The guidance is specific to soy clinical research and does not address nonsoy-related factors that should also be considered in designing and reporting clinical studies. This guidance may be used by investigators, journal editors, study sponsors, and protocol reviewers for a variety of purposes, including designing and implementing trials, reporting results, and interpreting published epidemiological and clinical studies. PMID:20392880

A Systematic Review on the Designs of Clinical Technology: Findings and Recommendations for Future Research

PubMed Central

PhD, Greg Alexander; Staggers, Nancy

2010-01-01

Human factors (HF) studies are increasingly important as technology infuses into clinical settings. No nursing research reviews exist in this area. The authors conducted a systematic review on designs of clinical technology, 34 articles with 50 studies met inclusion criteria. Findings were classified into three categories based on HF research goals. The majority of studies evaluated effectiveness of clinical design; efficiency was fewest. Current research ranges across many interface types examined with no apparent pattern or obvious rationale. Future research should expand types, settings, participants; integrate displays; and expand outcome variables. PMID:19707093

The Clinical Research Landscape in Rhode Island.

PubMed

Mao, George; Ramratnam, Bharat

2017-01-06

To present an overview of clinical research activity and the state of medical research funding in Rhode Island. We utilized clinicaltrials.gov registry to profile clinical studies between 2011 to 2016. NIH RePORT and other federal databases were used to extract information on levels of federal funding. Previously published hospital financial reports were reviewed for data on hospital-specific total external research funding. During 2011-2016, 1651 clinical studies were registered in clinicaltrials.gov. Nearly a third of all clinical studies were in oncology (21%) and cardiovascular diseases (10%). Alzheimer's dementia, breast cancer, HIV, and hepatitis C accounted for nearly 17% of all clinical trials. Seventy-five percent (75%) of clinical trials in RI were conducted in hospitals affiliated with Lifespan or Care New England. Financial support for clinical trials largely came from industry (60%) with 23% being supported by the National Institutes of Health (NIH). The rest are funded by nonprofit organizations, charitable foundations, educational institutions, and unlisted concerns. [Full article available at http://rimed.org/rimedicaljournal-2017-01.asp].

Patterns of clinical response to PSA elevation in American Indian/Alaska Native men: a multi-center pilot study.

PubMed

Tilburt, Jon C; Koller, Kathryn; Tiesinga, James J; Wilson, Robin T; Trinh, Anne C; Hill, Kristin; Hall, Ingrid J; Smith, Judith Lee; Ekwueme, Donatus U; Petersen, Wesley O

2013-11-01

To assess clinical treatment patterns and response times among American Indian/Alaska Native men with a newly elevated PSA. We retrospectively identified men ages 50-80 receiving care in one of three tribally-operated clinics in Northern Minnesota, one medical center in Alaska, and who had an incident PSA elevation (> 4 ng/ml) in a specified time period. A clinical response was considered timely if it was documented as occurring within 90 days of the incident PSA elevation. Among 82 AI/AN men identified from medical records with an incident PSA elevation, 49 (60%) received a timely clinical response, while 18 (22%) had no documented clinical response. One in five AI/AN men in our study had no documented clinical action following an incident PSA elevation. Although a pilot study, these findings suggest the need to improve the documentation, notification, and care following an elevated PSA at clinics serving AI/AN men.

Impact of a clinical trial initiative on clinical trial enrollment in a multidisciplinary prostate cancer clinic.

PubMed

Madsen, Lydia T; Kuban, Deborah A; Choi, Seungtaek; Davis, John W; Kim, Jeri; Lee, Andrew K; Domain, Delora; Levy, Larry; Pisters, Louis L; Pettaway, Curtis A; Ward, John F; Logothetis, Christopher; Hoffman, Karen E

2014-07-01

Clinical oncology trials are hampered by low accrual rates, with fewer than 5% of adult patients with cancer treated on study. Clinical trial enrollment was evaluated at The University of Texas MD Anderson Cancer Center's Multidisciplinary Prostate Cancer Clinic (MPCC) to assess whether a clinical trial initiative, introduced in 2006, impacted enrollment. The trial initiative included posting trial-specific information in clinic, educating patients about appropriate clinical trial options during the treatment recommendation discussion, and providing patients with trial-specific educational information. The investigators evaluated the frequency of clinical trial enrollment for men with newly diagnosed prostate cancer seen in the MPCC from 2004 to 2008. Logistic regression evaluated the impact of patient characteristics and the clinical trial initiative on trial enrollment. The median age of the 1370 men was 64 years; 32% had low-risk, 49% had intermediate-risk, and 19% had high-risk disease. Overall, 74% enrolled in at least one trial and 29% enrolled in more than one trial. Trial enrollment increased from 39% before the initiative (127/326) to 84% (880/1044) after the trial initiative. Patient enrollment increased in laboratory studies (from 25% to 80%), quality-of-life studies (from 10% to 26%), and studies evaluating investigational treatments and systemic agents (from 6% to 15%) after the trial initiative. In multivariate analysis, younger men (P<.001) and men seen after implementation of the clinical trial initiative (P<.001) were more likely to enroll in trials. Clinical trial enrollment in the MPCC was substantially higher than that seen nationally in adult patients with cancer, and enrollment rates increased after the introduction of a clinical trial initiative. Copyright © 2014 by the National Comprehensive Cancer Network.

Clinical nurse specialists as entrepreneurs: constrained or liberated.

PubMed

Austin, Lynn; Luker, Karen; Roland, Martin; Ronald, Martin

2006-12-01

This qualitative study explored the experiences of two groups of clinical nurse specialists--continence advisors and tissue viability nurses--working in primary care in the UK. In particular, the study focused on how clinical nurse specialists' relationships with other health-care professionals had an impact on their role. Clinical nurse specialists are recognized worldwide as having expertise in a given field, which they use to develop the practice of others. Additionally, clinical nurse specialists share many of the characteristics of entrepreneurs, which they use to develop services related to their speciality. However, little research has been conducted in relation to clinical nurse specialists' experiences as they attempt to diversify nursing practice. An ethnographic approach was adopted comprising many elements of Glaserian grounded theory. Data were collected via participant observation and face-to-face interviews with 22 clinical nurse specialists. Services provided by clinical nurse specialists were not static, clinical nurse specialists being the main drivers for service developments. However, clinical nurse specialists encountered difficulties when introducing new ideas. Given their role as advisors, clinical nurse specialists lacked authority to bring about change and were dependent on a number of mechanisms to bring about change, including 'cultivating relationships' with more powerful others, most notably the speciality consultant. The UK government has pledged to 'liberate the talents of nurses' so that their skills can be used to progress patient services. This study highlights the fact that a lack of collaborative working practices between health-care professionals led to clinical nurse specialists being constrained. Health-care organizations need to provide an environment in which the entrepreneurial skills of clinical nurse specialists may be capitalized on. In the absence of an outlet for their ideas regarding service developments, clinical nurse specialists may remain dependent on the mechanisms witnessed in this study for some time.

Invited review: A systematic review and qualitative analysis of treatments other than conventional antimicrobials for clinical mastitis in dairy cows.

PubMed

Francoz, D; Wellemans, V; Dupré, J P; Roy, J P; Labelle, F; Lacasse, P; Dufour, S

2017-10-01

Clinical mastitis is an important disease in dairies. Its treatment is mainly based on the use of antimicrobial drugs. Numerous non-antimicrobial drugs and treatment strategies have already been reported for clinical mastitis treatment, but data on their efficacy have never been collated in a systematic way. The objective of this systematic review was to identify treatments other than conventional antimicrobials for the treatment of clinical mastitis in lactating dairy cows. A systematic review was performed with studies written in English or French selected from CAB Abstracts, PubMed, and Web of Science from January 1970 to June 2014. Controlled clinical trials, observational studies, and experimental challenges were retained. Lactating dairy cows with clinical mastitis were the participant of interest. All treatments other than conventional antimicrobials for clinical mastitis during lactation were retained. Only studies comparing the treatment under investigation to a negative or positive control, or both, were included. Outcomes evaluated were clinical and bacteriological cure rates and milk production. Selection of the study, data extraction, and assessment of risk of bias was performed by 3 reviewers. Assessment of risk of bias was evaluated using the Cochrane Collaboration tool for systematic review of interventions. A total of 2,451 manuscripts were first identified and 39 manuscripts corresponding to 41 studies were included. Among these, 22 were clinical trials, 18 were experimental studies, and 1 was an observational study. The treatments evaluated were conventional anti-inflammatory drugs (n = 14), oxytocin with or without frequent milk out (n = 5), biologics (n = 9), homeopathy (n = 5), botanicals (n = 4), probiotics (n = 2), and other alternative products (n = 2). All trials had at least one unclear or high risk of bias. Most trials (n = 13) did not observe significant differences in clinical or bacteriological cure rates in comparison with negative or positive controls. Few studies evaluated the effect of treatment on milk yield. In general, the power of the different studies was very low, thus precluding conclusions on noninferiority or nonsuperiority of the treatments investigated. No evidence-based recommendations could be given for the use of an alternative or non-antimicrobial conventional treatment for clinical mastitis. However, probiotics and oxytocin with or without frequent milk out should not be recommended. We concluded that homeopathic treatments are not efficient for management of clinical mastitis. The Authors. Published by the Federation of Animal Science Societies and Elsevier Inc. on behalf of the American Dairy Science Association®. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).

The next generation of sepsis clinical trial designs: what is next after the demise of recombinant human activated protein C?*.

PubMed

Opal, Steven M; Dellinger, R Phillip; Vincent, Jean-Louis; Masur, Henry; Angus, Derek C

2014-07-01

The developmental pipeline for novel therapeutics to treat sepsis has diminished to a trickle compared to previous years of sepsis research. While enormous strides have been made in understanding the basic molecular mechanisms that underlie the pathophysiology of sepsis, a long list of novel agents have now been tested in clinical trials without a single immunomodulating therapy showing consistent benefit. The only antisepsis agent to successfully complete a phase III clinical trial was human recumbent activated protein C. This drug was taken off the market after a follow-up placebo-controlled trial (human recombinant activated Protein C Worldwide Evaluation of Severe Sepsis and septic Shock [PROWESS SHOCK]) failed to replicate the favorable results of the initial registration trial performed ten years earlier. We must critically reevaluate our basic approach to the preclinical and clinical evaluation of new sepsis therapies. We selected the major clinical studies that investigated interventional trials with novel therapies to treat sepsis over the last 30 years. Phase II and phase III trials investigating new treatments for sepsis and editorials and critiques of these studies. Selected manuscripts and clinical study reports were analyzed from sepsis trials. Specific shortcomings and potential pit falls in preclinical evaluation and clinical study design and analysis were reviewed and synthesized. After review and discussion, a series of 12 recommendations were generated with suggestions to guide future studies with new treatments for sepsis. We need to improve our ability to define appropriate molecular targets for preclinical development and develop better methods to determine the clinical value of novel sepsis agents. Clinical trials must have realistic sample sizes and meaningful endpoints. Biomarker-driven studies should be considered to categorize specific "at risk" populations most likely to benefit from a new treatment. Innovations in clinical trial design such as parallel crossover design, alternative endpoints, or adaptive trials should be pursued to improve the outlook for future interventional trials in sepsis.

[Study of dermatophytoses in Lanzarote (1995-199)].

PubMed

Piqué, Enric; Fuste, Rafel; Copado, Rodolfo; Noguera, Javier; Ramis, Pedro

2002-09-01

We report on the incidence of dermatophytes isolated in Lanzarote island from June-95 to December-99. We gathered 76 samples. Tinea corporis was the most frequent (40.79%) condition, and after this, tinea pedis (26.31%). Trichophyton rubrum was the commonest agent isolated involving 52.63% of patients. We compare our results with other canarian studies, and with clinical patterns described in other spanish studies published in the 1990's. From these comparations we can deduce: a) The distribution of clinical pictures is not homogeneous among the papers, b) tinea corporis etiology is heterogeneous among the series and c) tinea pedis etiology is homogeneous in most of studies. We believe that the comparison by clinical forms avoids any bias due to distribution of clinical forms.

Translational phases of evidence in a prognostic biomarker: a systematic review and meta-analysis of natriuretic peptides and the prognosis of stable coronary disease.

PubMed

Sutaria, Shailen; Philipson, Peter; Fitzpatrick, Natalie K; Abrams, Keith; Moreno, Santiago G; Timmis, Adam; Hingorani, Aroon D; Hemingway, Harry

2012-04-01

Translational phases of study are important in evaluating whether a prognostic biomarker is likely to have impact on clinical practice but systematic evaluations of such evidence are lacking. To systematically evaluate the clinical usefulness of the published literature on the association of natriuretic peptides (NP) and prognosis in stable coronary disease. MEDLINE and EMBASE until the end of July 2009, without restrictions. Prospective studies measuring NP in people with stable coronary disease who were followed-up for all cause mortality, coronary or cardiovascular events. Two independent reviewers categorised studies according to the American Heart Association phase of study, and extracted data according to the study reporting guidelines from the American Heart Association and REMARK. Systematic review of 19 studies found 17 which were phase 2, reporting an association between NP and events, two phase 3 studies, statistically examining the incremental prognostic value of NP, but no studies assessing whether NP predicted risk sufficiently to change management (phase 4), improve clinical outcomes (phase 5) or cost effectiveness (phase 6). No study referred to a statistical analytic protocol. Meta-analysis of 14 studies, reporting 18,841 patients and 1655 outcome events, found an RR for events of 3.28 (95% CI 2.45 to 4.38) comparing top versus bottom third of NP. This effect was 26% lower among the five studies which adjusted for a priori confounders (age, sex, renal function and left ventricular function) and 38% lower when adjusting for publication bias (Egger's p=0.001). The unbiased strength of association of NP with prognosis in stable coronary disease is unclear, and there is a lack of reports of clinically useful measures of prediction and discrimination or studies relating NP levels to clinical decision making. The available literature is confined to early phases and is of limited clinical usefulness.

The clinical and financial impact of a pediatric surgical neuro-oncology clinical trial.

PubMed

Thompson, Eric M; Gururangan, Sridharan; Grant, Gerald; Mitchell, Duane; Sampson, John H

2017-03-01

Pediatric surgical trials are rare and the impact of such trials on the institutions in which they are conducted is unknown. The purpose of this study was to analyze the clinical and financial impact of The Re-MATCH trial, a Phase I clinical trial requiring the biopsy or resection of recurrent medulloblastoma or PNET for enrollment. Inpatient financial and clinical volume information was collected during the 3 years of trial enrollment and the years preceding and following it. The primary endpoints were the difference in direct contribution margin (DCM), or net gain, of study and non-study patients and the difference in surgical volume during the study and non-study periods. The trial enrolled 18 patients; 15 had surgery at the sponsor institution and three had surgery at their home institution, then transferred tumor material to the sponsor institution. There were no differences between the two groups for potentially confounding variables such as neurosurgical procedure work relative value units (P = 0.13) or insurance provider (P = 0.26). There was no difference between the inpatient DCM per case for the institution for non-study patients (mean ± SD, $9039 ± $28,549) and study patients ($14,332 ± $20,231) (P = 0.4819). During the non-study period, there were a mean of 2.78 ± 1.65 pediatric brain tumor resections per month compared to 3.34 ± 1.66 cases per month during the study period, a 17% increase. When the 15 study patients were excluded, there were 2.97 ± 1.64 cases per month, a 7% increase. However, this increase in total case volume including study and non-study patients was not significant (P = 0.121). Phase I investigator-initiated surgically-based clinical trials may increase institutional surgical volume without imposing a financial burden. Finances are unlikely to be a barrier for researchers negotiating for resources to conduct such trials.

How to measure kyphosis in everyday clinical practice: a reliability study on different methods.

PubMed

Zaina, Fabio; Donzelli, Sabrina; Lusini, Monia; Negrini, Stefano

2012-01-01

The sagittal plane measures have a relevant role both in Idiopathic Scoliosis (AIS) and in Hyperkyphosis (HK) management. Nevertheless, clinical tools for everyday use are scarce and not adequately studied. To assess the repeatability of different methods for the collection of the sagittal profile of patients with spinal deformities during everyday clinics. We performed 4 different studies in 4 different populations of AIS and HK patients. In the first study we reported the normative data and measurement error of the plumbline measures in a general population of 180 adolescents. In the second study we compared the sagittal distances from the plumbline of C7, T12, L3, and Sagittal Index (SI = C7+L3) with the measures of the Video Rasterstereography at the same levels and the angles of kyphosis and lordosis in 100 AIS patients. In the third study we evaluated the intra and inter-rater repeatability and the measurement error of kyphosis and lordosis angles measured with the Inclimed in 100 AIS patients. In the last study we evaluated the repeatability of the sagittal distances from the plumbline, by using a 1 mm change instead of 5 mm in a population of 40 patients. repeatability has been evaluated according to Bland and Altman, to identify the limits of variation that are clinically significant. Results. Study 1: the normative data were: females: 34 ± 11 mm for C7; 34 ± 15 mm for L3, males: 34 ± 10 mm for C7; 48 ± 10 mm for L3;. Study 2: a coefficient of correlation was calculated in order to compare measures. Study 3: the k value for Inclimed varied from fair to good. Study 4: the repeatability was fair for this measure. Some clinical instruments are now available for sagittal plane assessment in AIS and hyperkyphosis. The results of the present study report the limits during measurements in a clinical setting of parameters that are routinely collected by some clinicians.

Clinical evidence for orphan medicinal products-a cause for concern?

PubMed

Picavet, Eline; Cassiman, David; Hollak, Carla E; Maertens, Johan A; Simoens, Steven

2013-10-16

The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at the time of marketing authorization, are too low. Therefore, the aim of this study was to quantitatively evaluate the characteristics and quality of clinical evidence that is presented for OMPs to obtain marketing authorization in Europe, using the new and validated COMPASS tool. We quantitatively assessed the characteristics and quality of clinical evidence of the pivotal studies of 64 OMPs as described in the European Public Assessment Report and/or the Scientific Discussion document prepared by the Committee for Human Medicinal Products of the EMA. The 64 OMPs were altogether authorized for 78 orphan indications, for which 117 studies were identified as 'pivotal' or 'main' studies. In approximately two thirds of the studies, the allocation was randomized (64.8%) and a control arm was used (68.5%). Half of the studies applied some type of blinding. Only a minority (26.9%) of the studies included a Quality-of-Life (QoL) related endpoint, of which a third claim an improvement in QoL. Upon analyzing the quality of reporting, we found that some aspects (i.e. the endpoints, the sampling criteria, and the interventions) are well described, whereas other items (i.e. a description of the patients and of potential biases) are not reported for all studies. In conclusion, the pivotal studies that are the basis for marketing authorization of OMPs are a cause for concern, as they exhibit methodological flaws i.e. the lack of QoL-related endpoints as outcome, lack of blinding in the study design and the use of surrogate endpoints. Additionally, there are shortcomings in the reporting of those studies that complicate the interpretation. A more demanding regulatory process for OMPs is needed to guide evidence-based clinical decision-making.

A qualitative study on acceptable levels of risk for pregnant women in clinical research.

PubMed

van der Zande, Indira S E; van der Graaf, Rieke; Oudijk, Martijn A; van Delden, Johannes J M

2017-05-15

There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study. We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members (RECs) and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands. Three themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals' individual perception of risk may influence recruitment. Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women.

[Analysis of the quality of papers dealing with clinical trails in "Chinese Journal of Burns" during 2000-2004 by the standard of evidence-based medicine].

PubMed

Jia, Chi-yu; Wang, Yun-chuan; Bai, Feng

2006-02-01

To investigate the quality of reports of clinical results concerning burn injury, in order to raise the standard of clinical study of burn care in accordance to the standard of evidence-based medicine (EBM), with the aim of improving clinical research in burn care of this country. All the papers of clinical study published in Chinese Journal of Burns (CJB) from 2000 to 2004 were evaluated according to EBM standard. There were 89 papers about clinical trials published in the past 5 years, in which 43 (48.3%) of the studies were carried out with random control trials (RCT), and 46 (51.7%) were clinical control trials (CCT). RCT papers increased year by year, while the number of CCT papers fluctuated greatly. The disparity in the quality of research was found as follows. In all the RCT and CCT papers, blinded research was adopted only in 5 papers (5.6%). Strict diagnostic standard including inclusion and exclusion standards were reported in 53 articles (59.6%). The comparison with baselines was not provided in 64 articles (71.9%). P value was given in 10 papers but statistical method was not mentioned (11.2%). Follow-up visits and lost information were only recorded in 2 articles, but no detailed follow-up visiting data were provided. Side effects were reported in 10 articles (11.2%). There were analysis and explanation of mixed interfering factors only in 5 papers (5.6%). There was no explanation of the evaluation of sample size in any one paper. In summary, the literature concerning clinical studies published in CJB in the past five years has become more extensive. However, the present study indicates that many clinical trials are not designed and ethical consideration is often missing. Therefore, it is deemed imperative to improve the quality of the clinical studies by improving the planning of the protocols of the study and statistical analysis of the research results in future.

The effectiveness of clinical networks in improving quality of care and patient outcomes: a systematic review of quantitative and qualitative studies.

PubMed

Brown, Bernadette Bea; Patel, Cyra; McInnes, Elizabeth; Mays, Nicholas; Young, Jane; Haines, Mary

2016-08-08

Reorganisation of healthcare services into networks of clinical experts is increasing as a strategy to promote the uptake of evidence based practice and to improve patient care. This is reflected in significant financial investment in clinical networks. However, there is still some question as to whether clinical networks are effective vehicles for quality improvement. The aim of this systematic review was to ascertain the effectiveness of clinical networks and identify how successful networks improve quality of care and patient outcomes. A systematic search was undertaken in accordance with the PRISMA approach in Medline, Embase, CINAHL and PubMed for relevant papers between 1 January 1996 and 30 September 2014. Established protocols were used separately to examine and assess the evidence from quantitative and qualitative primary studies and then integrate findings. A total of 22 eligible studies (9 quantitative; 13 qualitative) were included. Of the quantitative studies, seven focused on improving quality of care and two focused on improving patient outcomes. Quantitative studies were limited by a lack of rigorous experimental design. The evidence indicates that clinical networks can be effective vehicles for quality improvement in service delivery and patient outcomes across a range of clinical disciplines. However, there was variability in the networks' ability to make meaningful network- or system-wide change in more complex processes such as those requiring intensive professional education or more comprehensive redesign of care pathways. Findings from qualitative studies indicated networks that had a positive impact on quality of care and patients outcomes were those that had adequate resources, credible leadership and efficient management coupled with effective communication strategies and collaborative trusting relationships. There is evidence that clinical networks can improve the delivery of healthcare though there are few high quality quantitative studies of their effectiveness. Our findings can provide policymakers with some insight into how to successfully plan and implement clinical networks by ensuring strong clinical leadership, an inclusive organisational culture, adequate resourcing and localised decision-making authority.

Factors influencing radiation therapy student clinical placement satisfaction

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bridge, Pete; Carmichael, Mary-Ann

Introduction: Radiation therapy students at Queensland University of Technology (QUT) attend clinical placements at five different clinical departments with varying resources and support strategies. This study aimed to determine the relative availability and perceived importance of different factors affecting student support while on clinical placement. The purpose of the research was to inform development of future support mechanisms to enhance radiation therapy students’ experience on clinical placement. Methods: This study used anonymous Likert-style surveys to gather data from years 1 and 2 radiation therapy students from QUT and clinical educators from Queensland relating to availability and importance of support mechanismsmore » during clinical placements in a semester. Results: The study findings demonstrated student satisfaction with clinical support and suggested that level of support on placement influenced student employment choices. Staff support was perceived as more important than physical resources; particularly access to a named mentor, a clinical educator and weekly formative feedback. Both students and educators highlighted the impact of time pressures. Conclusions: The support offered to radiation therapy students by clinical staff is more highly valued than physical resources or models of placement support. Protected time and acknowledgement of the importance of clinical education roles are both invaluable. Joint investment in mentor support by both universities and clinical departments is crucial for facilitation of effective clinical learning.« less

A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design.

PubMed

Goswami, Neela D; Tsalik, Ephraim L; Naggie, Susanna; Miller, William C; Horton, John R; Pfeiffer, Christopher D; Hicks, Charles B

2014-01-22

The proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves. We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition. The crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials. No significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology.

A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design

PubMed Central

2014-01-01

Background The proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves. Methods We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition. Results The crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials. Conclusions No significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology. PMID:24450313

Evaluation of the clinical process in a critical care information system using the Lean method: a case study

PubMed Central

2012-01-01

Background There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. Methods We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. Results We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. Conclusions The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy. PMID:23259846

Educational climate seems unrelated to leadership skills of clinical consultants responsible of postgraduate medical education in clinical departments.

PubMed

Malling, Bente; Mortensen, Lene S; Scherpbier, Albert J J; Ringsted, Charlotte

2010-09-21

The educational climate is crucial in postgraduate medical education. Although leaders are in the position to influence the educational climate, the relationship between leadership skills and educational climate is unknown. This study investigates the relationship between the educational climate in clinical departments and the leadership skills of clinical consultants responsible for education. The study was a trans-sectional correlation study. The educational climate was investigated by a survey among all doctors (specialists and trainees) in the departments. Leadership skills of the consultants responsible for education were measured by multi-source feedback scores from heads of departments, peer consultants, and trainees. Doctors from 42 clinical departments representing 21 specialties participated. The response rate of the educational climate investigation was moderate 52% (420/811), Response rate was high in the multisource-feedback process 84.3% (420/498). The educational climate was scored quite high mean 3.9 (SD 0.3) on a five-point Likert scale. Likewise the leadership skills of the clinical consultants responsible for education were considered good, mean 5.4 (SD 0.6) on a seven-point Likert scale. There was no significant correlation between the scores concerning the educational climate and the scores on leadership skills, r = 0.17 (p = 0.29). This study found no relation between the educational climate and the leadership skills of the clinical consultants responsible for postgraduate medical education in clinical departments with the instruments used. Our results indicate that consultants responsible for education are in a weak position to influence the educational climate in the clinical department. Further studies are needed to explore, how heads of departments and other factors related to the clinical organisation could influence the educational climate.

Pedagogical strategies used in clinical medical education: an observational study

PubMed Central

2010-01-01

Background Clinical teaching is a complex learning situation influenced by the learning content, the setting and the participants' actions and interactions. Few empirical studies have been conducted in order to explore how clinical supervision is carried out in authentic situations. In this study we explore how clinical teaching is carried out in a clinical environment with medical students. Methods Following an ethnographic approach looking for meaning patterns, similarities and differences in how clinical teachers manage clinical teaching; non-participant observations and informal interviews were conducted during a four month period 2004-2005. The setting was at a teaching hospital in Sweden. The participants were clinical teachers and their 4th year medical students taking a course in surgery. The observations were guided by the aim of the study. Observational notes and notes from informal interviews were transcribed after each observation and all data material was analysed qualitatively. Results Seven pedagogical strategies were found to be applied, namely: 1) Questions and answers, 2) Lecturing, 3) Piloting, 4) Prompting, 5) Supplementing, 6) Demonstrating, and 7) Intervening. Conclusions This study contributes to previous research in describing a repertoire of pedagogical strategies used in clinical education. The findings showed that three superordinate qualitatively different ways of teaching could be identified that fit Ramsden's model. Each of these pedagogical strategies encompass different focus in teaching; either a focus on the teacher's knowledge and behaviour or the student's behaviour and understanding. We suggest that an increased awareness of the strategies in use will increase clinical teachers' teaching skills and the consequences they will have on the students' ability to learn. The pedagogical strategies need to be considered and scrutinized in further research in order to verify their impact on students' learning. PMID:20105340

Evaluation of the clinical process in a critical care information system using the Lean method: a case study.

PubMed

Yusof, Maryati Mohd; Khodambashi, Soudabeh; Mokhtar, Ariffin Marzuki

2012-12-21

There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy.

Mental Subnormality in the Community: A Clinical and Epidemiologic Study.

ERIC Educational Resources Information Center

Birch, Herbert G.; And Others

The book reports a clinical and epidemiologic study of the prevalence, distribution, and antecedents of mental subnormality in 8 to 10 year old children living in Aberdeen, Scotland (population 187,000). Utilizing three types of data (differential clinical diagnoses, biological background information, and social characteristics), the study…

Virtual Patient Simulations for Medical Education: Increasing Clinical Reasoning Skills through Deliberate Practice

ERIC Educational Resources Information Center

McCoy, Lise

2014-01-01

Virtual Patient Simulations (VPS) are web-based exercises involving simulated patients in virtual environments. This study investigates the utility of VPS for increasing medical student clinical reasoning skills, collaboration, and engagement. Many studies indicate that VPS provide medical students with essential practice in clinical decision…

Towards Evidence-Based Practice in Language Intervention for Bilingual Children

ERIC Educational Resources Information Center

Thordardottir, Elin

2010-01-01

Evidence-based practice requires that clinical decisions be based on evidence from rigorously controlled research studies. At this time, very few studies have directly examined the efficacy of clinical intervention methods for bilingual children. Clinical decisions for this population cannot, therefore, be based on the strongest forms of research…

Psychometric Structure of a Comprehensive Objective Structured Clinical Examination: A Factor Analytic Approach

ERIC Educational Resources Information Center

Volkan, Kevin; Simon, Steven R.; Baker, Harley; Todres, I. David

2004-01-01

Problem Statement and Background: While the psychometric properties of Objective Structured Clinical Examinations (OSCEs) have been studied, their latent structures have not been well characterized. This study examines a factor analytic model of a comprehensive OSCE and addresses implications for measurement of clinical performance. Methods: An…

Students' Perspectives of Same-Day Clinical Assignments: A Qualitative Descriptive Study.

PubMed

Harris, Allyssa L; Stamp, Kelly D

2016-01-01

The clinical experience is essential to the nursing education process, but the process by which students are assigned patients has remained unchanged for decades. The purpose of this qualitative descriptive study was to determine the acceptability of a same-day clinical assignment process from the perspective of pre-licensure nursing students. Students' (n = 104) perceptions of the same-day clinical assignment process were collected via focus groups. Two themes emerged that may assist educators in implementing new methods for clinical assignments.

Does informed consent given by healthy individuals when enrolling in clinical research feel less voluntary than for ill individuals?

PubMed

Roberts, Laura; Kim, Jane Paik

2018-04-30

Clinical research is predicated ethically on the authentic voluntarism of individuals who choose to enroll in human studies. Existing literature has focused on aspects of informed consent for clinical research other than voluntarism. The objective of this study was to compare the perspectives of clinical research participants who are in good health and who are ill regarding voluntarism-related aspects of informed consent and to assess situational influences that enable voluntarism in the process of obtaining clinical research consent. A 23-item written survey, the Informed Consent Questionnaire (ICQ), was administered in a "piggyback" semi-structured interview study of ill and healthy volunteers enrolled in IRB-approved clinical research studies. A total of 150 (60 mentally ill, 43 physically ill, and 47 healthy) clinical research participants participated. Respondents expressed positive views of their experiences with the informed consent processes for their respective clinical research protocols and respondents strongly endorsed items related to voluntarism irrespective of their illness type (range of means = [3.9, 4.8]). Ill participants more highly endorsed items relating to informed consent conditions (mentally ill vs healthy: 0.54 on a 5-point scale, P value = 0.01) (physically ill vs. healthy: 0.47 on a 5-point scale, P value = 0.01). The favorable views of clinical research participants regarding their experience of giving informed consent to enroll in a study were not surprising. Contrary to our a priori hypothesis, healthy individuals did not feel as positively as their ill counterparts. Copyright © 2018 Elsevier Ltd. All rights reserved.

Assessing the effectiveness of strategies to implement clinical guidelines for the management of chronic diseases at primary care level in EU Member States: a systematic review.

PubMed

Brusamento, Serena; Legido-Quigley, Helena; Panteli, Dimitra; Turk, Eva; Knai, Cecile; Saliba, Vanessa; Car, Josip; McKee, Martin; Busse, Reinhard

2012-10-01

This review aimed to evaluate the effectiveness of strategies to implement clinical guidelines for chronic disease management in primary care in EU Member States. We conducted a systematic review of interventional studies assessing the implementation of clinical guidelines. We searched five databases (EMBASE, MEDLINE, CENTRAL, Eppi-Centre and Clinicaltrials.gov) following a strict Cochrane methodology. We included studies focusing on the management of chronic diseases in adults in primary care. A total of 21 studies were found. The implementation strategy was fully effective in only four (19%), partially effective in eight (38%), and not effective in nine (43%). The probability that an intervention would be effective was only slightly higher with multifaceted strategies, compared to single interventions. However, effect size varied across studies; therefore it was not possible to determine the most successful strategy. Only eight studies evaluated the impact on patients' health and only two of those showed significant improvement, while in five there was an improvement in the process of care which did not translate into an improvement in health outcomes. Only four studies reported any data on the cost of the implementation but none undertook a cost-effectiveness analysis. Only one study presented data on the barriers to the implementation of guidelines, noting a lack of awareness and agreement about clinical guidelines. Our results reveal that there are only a few rigorous studies which assess the effectiveness of a strategy to implement clinical guidelines in Europe. Moreover, the results are not consistent in showing which strategy is the most appropriate to facilitate their implementation. Therefore, further research is needed to develop more rigorous studies to evaluate health outcomes associated with the implementation of clinical guidelines; to assess the cost-effectiveness of implementing clinical guidelines; and to investigate the perspective of service users and health service staff. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Implementing Single Source: The STARBRITE Proof-of-Concept Study

PubMed Central

Kush, Rebecca; Alschuler, Liora; Ruggeri, Roberto; Cassells, Sally; Gupta, Nitin; Bain, Landen; Claise, Karen; Shah, Monica; Nahm, Meredith

2007-01-01

Objective Inefficiencies in clinical trial data collection cause delays, increase costs, and may reduce clinician participation in medical research. In this proof-of-concept study, we examine the feasibility of using point-of-care data capture for both the medical record and clinical research in the setting of a working clinical trial. We hypothesized that by doing so, we could increase reuse of patient data, eliminate redundant data entry, and minimize disruption to clinic workflow. Design We developed and used a point-of-care electronic data capture system to record data during patient visits. The standards-based system was used for clinical research and to generate the clinic note for the medical record. The system worked in parallel with data collection procedures already in place for an ongoing multicenter clinical trial. Our system was iteratively designed after analyzing case report forms and clinic notes, and observing clinic workflow patterns and business procedures. Existing data standards from CDISC and HL7 were used for database insertion and clinical document exchange. Results Our system was successfully integrated into the clinic environment and used in two live test cases without disrupting existing workflow. Analyses performed during system design yielded detailed information on practical issues affecting implementation of systems that automatically extract, store, and reuse healthcare data. Conclusion Although subject to the limitations of a small feasibility study, our study demonstrates that electronic patient data can be reused for prospective multicenter clinical research and patient care, and demonstrates a need for further development of therapeutic area standards that can facilitate researcher use of healthcare data. PMID:17600107

Safety Analysis of Panax Ginseng in Randomized Clinical Trials: A Systematic Review

PubMed Central

Kim, Young-Sook; Woo, Jung-Yoon; Han, Chang-Kyun; Chang, Il-Moo

2015-01-01

Background: Panax ginseng C.A. Meyer is one of the most frequently used herbs in the world. The roots of Panax ginseng have been used as a traditional tonic and medicine for thousands of years in Korea and China. Today, ginseng root is used as a dietary supplement and complementary medicine and for adjuvant therapeutics worldwide. The efficacy of ginseng has been studied in a wide range of basic research and clinical studies. However, it has been reported that the results from clinical studies are conflicting, and they depend on the parameters of the protocol design including the conditions of the participants and the types of ginseng used such as red ginseng, white ginseng, fermented ginseng and cultured ginseng. Meanwhile, in addition to clinical efficacy, the safety of ginseng is a highly important matter for customers. With globally increasing demand for Panax ginseng as a dietary supplement or complementary medicine, it is necessary to provide information on its safe use to customers to improve their health conditions. Although the safety of Panax ginseng in pre-clinical studies is well known, the evaluation of safety in clinical studies has so far been insufficient. This systematic review was conducted to assess the safety of ginseng in randomized controlled clinical trials (RCT) over the last 10 years. We chose the last 10 years because many clinical trials have been conducted in the past 10 years, and it will help to understand the recent trends in RCTs of ginseng. Methods: Articles on ginseng studies were searched with keywords in MEDLINE and four other Korean online database sites. Studies with ginseng as a monopreparation were selected while studies with single administration, preparations combined with other herbs or drug combinations were excluded from the selected studies. Data from the selected studies meeting the criteria were extracted and reviewed in terms of study design, condition and number of participants, type of ginseng, dosage, duration, main results, adverse events and adverse reactions. Results: Forty-four studies met the selection criteria. These studies covered the efficacy of ginseng in areas such as cardiovascular function, glucose metabolism, sexual function, anti-oxidation, anti-fatigue and psychomotor function. Twenty-nine studies showed positive results while fifteen studies showed no effect. Sixteen studies reported adverse events while five studies had no adverse events. Twenty-three studies did not mention any adverse events. The main adverse events of ginseng reported were general symptoms such as hot flushes, insomnia and dyspepsia with no significant difference in frequency and symptoms between the ginseng and placebo groups. The symptoms were mild and temporary with no serious or severe adverse events. Conclusion: Panax ginseng showed a very safe profile in a limited number of RCTs with a small number of participants with various conditions ranging from healthy participants to patients with symptoms. However, to increase the usefulness and lower the health risk of Panax ginseng to customers, clinical trials on a larger scale and with a higher standard are necessary to define its efficacy and safety as a dietary supplement or complementary medicine. PMID:28930204

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study

PubMed Central

Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

2014-01-01

Objective To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Design Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient’s trial identification number. Using the patient’s trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. Setting 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Data sources Clinical study reports obtained from the EMA in 2011. Results Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Conclusion Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the listings of adverse events for individual patients and narratives of adverse events can provide additional information, including original investigator reported adverse event terms, which can enable a more accurate estimate of harms. PMID:24899651

Promoting research and audit at medical school: evaluating the educational impact of participation in a student-led national collaborative study.

PubMed

Chapman, Stephen J; Glasbey, James C D; Khatri, Chetan; Kelly, Michael; Nepogodiev, Dmitri; Bhangu, Aneel; Fitzgerald, J Edward F

2015-03-13

Medical students often struggle to engage in extra-curricular research and audit. The Student Audit and Research in Surgery (STARSurg) network is a novel student-led, national research collaborative. Student collaborators contribute data to national, clinical studies while gaining an understanding of audit and research methodology and ethical principles. This study aimed to evaluate the educational impact of participation. Participation in the national, clinical project was supported with training interventions, including an academic training day, an online e-learning module, weekly discussion forums and YouTube® educational videos. A non-mandatory, online questionnaire assessed collaborators' self-reported confidence in performing key academic skills and their perceptions of audit and research prior to and following participation. The group completed its first national clinical study ("STARSurgUK") with 273 student collaborators across 109 hospital centres. Ninety-seven paired pre- and post-study participation responses (35.5%) were received (male = 51.5%; median age = 23). Participation led to increased confidence in key academic domains including: communication with local research governance bodies (p < 0.001), approaching clinical staff to initiate local collaboration (p < 0.001), data collection in a clinical setting (p < 0.001) and presentation of scientific results (p < 0.013). Collaborators also reported an increased appreciation of research, audit and study design (p < 0.001). Engagement with the STARSurg network empowered students to participate in a national clinical study, which increased their confidence and appreciation of academic principles and skills. Encouraging active participation in collaborative, student-led, national studies offers a novel approach for delivering essential academic training.

On the value of therapeutic interventions targeting the complement system in acute myocardial infarction.

PubMed

Emmens, Reindert W; Wouters, Diana; Zeerleder, Sacha; van Ham, S Marieke; Niessen, Hans W M; Krijnen, Paul A J

2017-04-01

The complement system plays an important role in the inflammatory response subsequent to acute myocardial infarction (AMI). The aim of this study is to create a systematic overview of studies that have investigated therapeutic administration of complement inhibitors in both AMI animal models and human clinical trials. To enable extrapolation of observations from included animal studies toward post-AMI clinical trials, ex vivo studies on isolated hearts and proof-of-principle studies on inhibitor administration before experimental AMI induction were excluded. Positive therapeutic effects in AMI animal models have been described for cobra venom factor, soluble complement receptor 1, C1-esterase inhibitor (C1-inh), FUT-175, C1s-inhibitor, anti-C5, ADC-1004, clusterin, and glycosaminoglycans. Two types of complement inhibitors have been tested in clinical trials, being C1-inh and anti-C5. Pexelizumab (anti-C5) did not result in reproducible beneficial effects for AMI patients. Beneficial effects were reported in AMI patients for C1-inhibitor, albeit in small patient groups. In general, despite the absence of consistent positive effects in clinical trials thus far, the complement system remains a potentially interesting target for therapy in AMI patients. Based on the study designs of previous animal studies and clinical trials, we discuss several issues which require attention in the design of future studies: adjustment of clinical trial design to precise mechanism of action of administered inhibitor, optimizing the duration of therapy, and optimization of time point(s) on which therapeutic effects will be evaluated. Copyright © 2016 Elsevier Inc. All rights reserved.

The effectiveness of toolkits as knowledge translation strategies for integrating evidence into clinical care: a systematic review

PubMed Central

Yamada, Janet; Shorkey, Allyson; Barwick, Melanie; Widger, Kimberley; Stevens, Bonnie J

2015-01-01

Objectives The aim of this systematic review was to evaluate the effectiveness of toolkits as a knowledge translation (KT) strategy for facilitating the implementation of evidence into clinical care. Toolkits include multiple resources for educating and/or facilitating behaviour change. Design Systematic review of the literature on toolkits. Methods A search was conducted on MEDLINE, EMBASE, PsycINFO and CINAHL. Studies were included if they evaluated the effectiveness of a toolkit to support the integration of evidence into clinical care, and if the KT goal(s) of the study were to inform, share knowledge, build awareness, change practice, change behaviour, and/or clinical outcomes in healthcare settings, inform policy, or to commercialise an innovation. Screening of studies, assessment of methodological quality and data extraction for the included studies were conducted by at least two reviewers. Results 39 relevant studies were included for full review; 8 were rated as moderate to strong methodologically with clinical outcomes that could be somewhat attributed to the toolkit. Three of the eight studies evaluated the toolkit as a single KT intervention, while five embedded the toolkit into a multistrategy intervention. Six of the eight toolkits were partially or mostly effective in changing clinical outcomes and six studies reported on implementation outcomes. The types of resources embedded within toolkits varied but included predominantly educational materials. Conclusions Future toolkits should be informed by high-quality evidence and theory, and should be evaluated using rigorous study designs to explain the factors underlying their effectiveness and successful implementation. PMID:25869686

Nursing students' viewpoints toward two methods of clinical conference and clinical nursing round.

PubMed

Gheidanzadeh, Maryam; Baghersad, Zahra; Abazari, Parvaneh

2017-01-01

Clinical education provides a chance to combine theoretical knowledge and clinical skills. Students are the key elements in the evaluation of clinical education efficacy. The present study was aimed to define nursing students' viewpoints concerning conformity to the characteristics of clinical conference and clinical round. This descriptive analytical study was conducted on the bachelor's students of the 4 th -6 th semester of nursing. Sampling was conducted using census sampling method during the 2 nd semester of 2014-2015 school year. Data collection tool was a three-section researcher-made questionnaire containing demographic, nursing round, and clinical conference characteristics. Descriptive and inferential statistical tests (independent t -test, ANOVA, and Spearman and Pearson correlation coefficients) were used for data analysis. Participants were 134 bachelor's students of the 4 th -6 th semester of nursing. According to half of the participants, conformity to the characteristics of clinical conference (45.5%, 53%) and clinical round (44%, 51.5%) were poor and medium, respectively. Paired t -test showed a significant difference between students' viewpoints toward the planning of clinical conference and clinical nursing round ( P = 0.006, t = 2.77). According to the results of the present study on students' viewpoints, clinical education faces a serious challenge with regard to clinical education methods. Considering the necessity and importance of clinical education, more investigation should be conducted to detect its relevant factors and plan for its improvement.

Does Pharmacogenomic Testing Improve Clinical Outcomes for Major Depressive Disorder? A Systematic Review of Clinical Trials and Cost-Effectiveness Studies.

PubMed

Rosenblat, Joshua D; Lee, Yena; McIntyre, Roger S

2017-06-01

Pharmacogenomic testing has become scalable and available to the general public. Pharmacogenomics has shown promise for predicting antidepressant response and tolerability in the treatment of major depressive disorder (MDD). In theory, pharmacogenomics can improve clinical outcomes by guiding antidepressant selection and dosing. The current systematic review examines the extant literature to determine the impact of pharmacogenomic testing on clinical outcomes in MDD and assesses its cost-effectiveness. The MEDLINE/PubMed and Google Scholar databases were systematically searched for relevant articles published prior to October 2015. Search terms included various combinations of the following: major depressive disorder (MDD), depression, mental illness, mood disorder, antidepressant, response, remission, outcome, pharmacogenetic, pharmacogenomics, pharmacodynamics, pharmacokinetic, genetic testing, genome wide association study (GWAS), CYP450, personalized medicine, cost-effectiveness, and pharmacoeconomics. Of the 66 records identified from the initial search, relevant clinical studies, written in English, assessing the cost-effectiveness and/or efficacy of pharmacogenomic testing for MDD were included. Each publication was critically examined for relevant data. Two nonrandomized, open-label, 8-week, prospective studies reported overall greater improvement in depressive symptom severity in the group of MDD subjects receiving psychiatric care guided by results of combinatorial pharmacogenomic testing (GeneSight) when compared to the unguided group. One industry-sponsored, randomized, double-blind, 10-week prospective study reported a trend for improved outcomes for the GeneSight-guided group; however, the trend did not reach statistical significance. Another industry-sponsored, randomized, double-blind, 12-week prospective study reported a 2.5-fold increase in remission rates in the CNSDose-guided group (P < .0001). One naturalistic, unblinded, industry-sponsored study showed clinical improvement when pharmacogenomics testing guided prescribing; however, this study lacked a control group. A single cost-effectiveness study concluded that single gene testing was not cost-effective. Conversely, a separate study reported that combinatorial pharmacogenomic testing is cost-effective. A limited number of studies have shown promise for the clinical utility of pharmacogenomic testing; however, cost-effectiveness of pharmacogenomics, as well as demonstration of improved health outcomes, is not yet supported with replicated evidence. © Copyright 2017 Physicians Postgraduate Press, Inc.

Literature searching for clinical and cost-effectiveness studies used in health technology assessment reports carried out for the National Institute for Clinical Excellence appraisal system.

PubMed

Royle, P; Waugh, N

2003-01-01

To contribute to making searching for Technology Assessment Reports (TARs) more cost-effective by suggesting an optimum literature retrieval strategy. A sample of 20 recent TARs. All sources used to search for clinical and cost-effectiveness studies were recorded. In addition, all studies that were included in the clinical and cost-effectiveness sections of the TARs were identified, and their characteristics recorded, including author, journal, year, study design, study size and quality score. Each was also classified by publication type, and then checked to see whether it was indexed in the following databases: MEDLINE, EMBASE, and then either the Cochrane Controlled Trials Register (CCTR) for clinical effectiveness studies or the NHS Economic Evaluation Database (NHS EED) for the cost-effectiveness studies. Any study not found in at least one of these databases was checked to see whether it was indexed in the Science Citation Index (SCI) and BIOSIS, and the American Society of Clinical Oncology (ASCO) Online if a cancer review. Any studies still not found were checked to see whether they were in a number of additional databases. The median number of sources searched per TAR was 20, and the range was from 13 to 33 sources. Six sources (CCTR, DARE, EMBASE, MEDLINE, NHS EED and sponsor/industry submissions to National Institute for Clinical Excellence) were used in all reviews. After searching the MEDLINE, EMBASE and NHS EED databases, 87.3% of the clinical effectiveness studies and 94.8% of the cost-effectiveness studies were found, rising to 98.2% when SCI, BIOSIS and ASCO Online and 97.9% when SCI and ASCO Online, respectively, were added. The median number of sources searched for the 14 TARs that included an economic model was 9.0 per TAR. A sensitive search filter for identifying non-randomised controlled trials (RCT), constructed for MEDLINE and using the search terms from the bibliographic records in the included studies, retrieved only 85% of the known sample. Therefore, it is recommended that when searching for non-RCT studies a search is done for the intervention alone, and records are then scanned manually for those that look relevant. Searching additional databases beyond the Cochrane Library (which includes CCTR, NHS EED and the HTA database), MEDLINE, EMBASE and SCI, plus BIOSIS limited to meeting abstracts only, was seldom found to be effective in retrieving additional studies for inclusion in the clinical and cost-effectiveness sections of TARs (apart from reviews of cancer therapies, where a search of the ASCO database is recommended). A more selective approach to database searching would suffice in most cases and would save resources, thereby making the TAR process more efficient. However, searching non-database sources (including submissions from manufacturers, recent meeting abstracts, contact with experts and checking reference lists) does appear to be a productive way of identifying further studies.

Use of mobile devices in nursing student-nurse teacher cooperation during the clinical practicum: an integrative review.

PubMed

Strandell-Laine, Camilla; Stolt, Minna; Leino-Kilpi, Helena; Saarikoski, Mikko

2015-03-01

To identify and appraise study findings on the use of mobile devices, in particular for what purposes and how, in nursing student-nurse teacher cooperation during the clinical practicum. A systematic literature search was conducted using the PubMed/Medline, CINAHL, PsycINFO and ERIC for primary empirical studies published in English. An integrative literature review was undertaken. Quality appraisal of the included studies was conducted using design-specific standardized checklists. Studies were thematically analyzed. Based on the inclusion and exclusion criteria, eleven studies were included in the review. Weaknesses in designs, samples, questionnaires and results, compromised comparison and/or generalization of the findings of the studies. Three main themes were identified: (1) features of mobile devices (2) utility of mobile devices and (3) barriers to the use of mobile devices. Problems of connectivity were the main challenges reported in the use of mobile devices. Participants used mobile devices primarily as reference tools, but less frequently as tools for reflection, assessment or cooperation during the clinical practicum. Interest in mobile device use during the clinical practicum was reported, but training and ongoing support are needed. As only a small number of eligible primary empirical studies were found, it is not possible to draw firm conclusions on the results. In the future, rigorous primary empirical studies are needed to explore the potential of mobile devices in providing a supplementary pedagogical method in nursing student-nurse teacher cooperation during the clinical practicum. Robust study designs, including experimental ones, are clearly needed to assess the effectiveness of mobile devices in nursing student-nurse teacher cooperation during the clinical practicum. Copyright © 2014 Elsevier Ltd. All rights reserved.

Concentration-Response Modeling of ECG Data From Early-Phase Clinical Studies as an Alternative Clinical and Regulatory Approach to Assessing QT Risk - Experience From the Development Program of Lemborexant.

PubMed

Murphy, Patricia J; Yasuda, Sanae; Nakai, Kenya; Yoshinaga, Takashi; Hall, Nancy; Zhou, Meijian; Aluri, Jagadeesh; Rege, Bhaskar; Moline, Margaret; Ferry, Jim; Darpo, Borje

2017-01-01

Lemborexant is a novel dual orexin receptor antagonist being developed to treat insomnia. Its potential to cause QT prolongation was evaluated using plasma concentration-response (CR) modeling applied to data from 2 multiple ascending-dose (MAD) studies. In the primary MAD study, placebo or lemborexant (2.5 to 75 mg) was administered for 14 consecutive nights. In another MAD study designed to "bridge" pharmacokinetic and safety data between Japanese and non-Japanese subjects (J-MAD), placebo or lemborexant (2.5, 10, or 25 mg) was administered for 14 consecutive nights. QT intervals were estimated using a high-precision measurement technique and evaluated using a linear mixed-effects CR model, for each study separately and for the pooled data set. When each study was analyzed separately, the slopes of the CR relationship were shallow and not statistically significant. In the pooled analysis, the slope of the CR relationship was -0.00002 milliseconds per ng/mL (90%CI, -0.01019 to 0.01014 milliseconds). The highest observed C max was 400 ng/mL, representing a margin 8-fold above exposures expected for the highest planned clinical dose. The model-predicted QTc effect at 400 ng/mL was 1.1 milliseconds (90%CI, -3.49 to 5.78 milliseconds). In neither the J-MAD study nor the pooled analysis was an effect of race identified. CR modeling of data from early-phase clinical studies, including plasma levels far exceeding those anticipated clinically, indicated that a QT effect >10 milliseconds could be excluded. Regulatory agreement with this methodology demonstrates the effectiveness of a CR modeling approach as an alternative to thorough QT studies. © 2016, The American College of Clinical Pharmacology.

Increases in heart rate and serum cortisol concentrations in healthy dogs are positively correlated with an indoor waiting-room environment.

PubMed

Perego, Roberta; Proverbio, Daniela; Spada, Eva

2014-03-01

Few studies have investigated the effect of veterinary clinical procedures on the welfare of dogs, with specific emphasis on the veterinary practice environment. Clinicopathologic variables have also not been assessed in these potentially stressful situations. Similar to human clinical studies, the veterinary clinical waiting room could present a significant stress factor for dogs. The present study was designed to investigate the effect of waiting-room environment on serum cortisol and glucose alterations as well as heart rate in privately owned healthy dogs. The clinical trial included 24 healthy dogs that were divided into 2 groups: the clinical waiting-room group (A) and the control group (B) that waited outside in a garden. During the entire experiment, 18 dogs (9 dogs per group) were monitored with a human heart rate monitor fastened around the chest. After 20 minutes of waiting, blood samples were collected from all of the dogs (24 dogs) to determine serum cortisol concentration. Serum cortisol concentration and mean, maximum, and minimum heart rate were significantly higher in group A compared with group B, but there was no statistical difference in serum glucose concentrations between the 2 study groups. Results of this study suggest that the waiting room is a potentially stressful situation for dogs in clinical veterinary practice, when compared with a garden, based on the assessment of adrenal cortex function and heart rate evaluation. © 2014 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.

Cross sectional study to evaluate the effect of duration of type 2 diabetes mellitus on the nerve conduction velocity in diabetic peripheral neuropathy.

PubMed

Hussain, Gauhar; Rizvi, S Aijaz Abbas; Singhal, Sangeeta; Zubair, Mohammad; Ahmad, Jamal

2014-01-01

To study the nerve conduction velocity in clinically undetectable and detectable peripheral neuropathy in type 2 diabetes mellitus with variable duration. This cross sectional study was conducted in diagnosed type 2 diabetes mellitus patients. They were divided in groups: Group I (n=37) with clinically detectable diabetic peripheral neuropathy of shorter duration and Group II (n=27) with clinically detectable diabetic peripheral neuropathy of longer duration. They were compared with T2DM patients (n=22) without clinical neuropathy. Clinical diagnosis was based on neuropathy symptom score (NSS) and neuropathy disability score (NDS) for signs. Nerve conduction velocity was measured in both upper and lower limbs. Median, ulnar, common peroneal and posterior tibial nerves were selected for motor nerve conduction study and median and sural nerves were selected for sensory nerve conduction study. The comparisons were done between nerve conduction velocities of motor and sensory nerves in patients of clinically detectable neuropathy and patients without neuropathy in type 2 diabetes mellitus population. This study showed significant electrophysiological changes with duration of disease. Nerve conduction velocities in lower limbs were significantly reduced even in patients of shorter duration with normal upper limb nerve conduction velocities. Diabetic neuropathy symptom score (NSS) and neuropathy disability score (NDS) can help in evaluation of diabetic sensorimotor polyneuropathy though nerve conduction study is more powerful test and can help in diagnosing cases of neuropathy. Copyright © 2013 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Clinical research evidence of cupping therapy in China: a systematic literature review.

PubMed

Cao, Huijuan; Han, Mei; Li, Xun; Dong, Shangjuan; Shang, Yongmei; Wang, Qian; Xu, Shu; Liu, Jianping

2010-11-16

Though cupping therapy has been used in China for thousands of years, there has been no systematic summary of clinical research on it.This review is to evaluate the therapeutic effect of cupping therapy using evidence-based approach based on all available clinical studies. We included all clinical studies on cupping therapy for all kinds of diseases. We searched six electronic databases, all searches ended in December 2008. We extracted data on the type of cupping and type of diseases treated. 550 clinical studies were identified published between 1959 and 2008, including 73 randomized controlled trials (RCTs), 22 clinical controlled trials, 373 case series, and 82 case reports. Number of RCTs obviously increased during past decades, but the quality of the RCTs was generally poor according to the risk of bias of the Cochrane standard for important outcome within each trials. The diseases in which cupping was commonly employed included pain conditions, herpes zoster, cough or asthma, etc. Wet cupping was used in majority studies, followed by retained cupping, moving cupping, medicinal cupping, etc. 38 studies used combination of two types of cupping therapies. No serious adverse effects were reported in the studies. According to the above results, quality and quantity of RCTs on cupping therapy appears to be improved during the past 50 years in China, and majority of studies show potential benefit on pain conditions, herpes zoster and other diseases. However, further rigorous designed trials in relevant conditions are warranted to support their use in practice.

Effect of antiretroviral therapy on clinical and immunologic disease progression in HIV positive children: One-year follow-up study

PubMed Central

Patel, Ankur; Trivedi, Sangeeta S.; Chudasama, Rajesh K.; Patel, Priyanka K.

2012-01-01

Objective: To study the effect of antiretroviral therapy (ART) on clinical, immunologic, and nutritional progression of disease in human immunodeficiency virus (HIV)-infected children for 1 year. Materials and Methods: The study included 54 children aged 1.5–15 years who registered at the ART center, Surat, from August 2007 to August 2009. During the study period, the children were followed-up at 6 monthly intervals up to 1 year after starting ART. World Health Organization (WHO) clinical staging and CD4 cell count as per national guidelines, and nutritional status were used to measure clinical and immunologic progression of disease up to 1 year. Results: Out of 54 children, mother-to-child transmission was reported in 96.2% children; for 74% of the children, both parents were HIV positive. All the children were classified according to WHO clinical staging into 4 stages and as per CD4 cell count (%), followed up at 6 and 12 months and the benefits with ART reported. At 12 months follow-up, 15% of the study group children had died. Both mean CD4 count and a relative percentage showed significant increase (P < 0.01) in the study group 1 year after ART. Conclusion: The present study reports benefits of ART in terms of clinical and immunologic progression of disease, nutritional status of HIV-infected children after 1 year of ART. PMID:23230384

Should applicants to Nottingham University Medical School study a non-science A-level? A cohort study.

PubMed

Yates, Janet; Smith, Jennifer; James, David; Ferguson, Eamonn

2009-01-21

It has been suggested that studying non-science subjects at A-level should be compulsory for medical students. Our admissions criteria specify only Biology, Chemistry and one or more additional subjects. This study aimed to determine whether studying a non-science subject for A-level is an independent predictor of achievement on the undergraduate medical course. The subjects of this retrospective cohort study were 164 students from one entry-year group (October 2000), who progressed normally on the 5-year undergraduate medical course at Nottingham. Pre-admission academic and socio-demographic data and undergraduate course marks were obtained. T-test and hierarchical multiple linear regression analyses were undertaken to identify independent predictors of five course outcomes at different stages throughout the course. There was no evidence that the choice of science or non-science as the third or fourth A-level subject had any influence on course performance. Demographic variables (age group, sex, and fee status) had some predictive value but ethnicity did not. Pre-clinical course performance was the strongest predictor in the clinical phases (pre-clinical Themes A&B (knowledge) predicted Clinical Knowledge, p < 0.001, and pre-clinical Themes C&D (skills) predicted Clinical Skills, p = or< 0.01). This study of one year group at Nottingham Medical School provided no evidence that the admissions policy on A-level requirements should specify the choice of third or fourth subject.

Should applicants to Nottingham University Medical School study a non-science A-level? A cohort study

PubMed Central

Yates, Janet; Smith, Jennifer; James, David; Ferguson, Eamonn

2009-01-01

Background It has been suggested that studying non-science subjects at A-level should be compulsory for medical students. Our admissions criteria specify only Biology, Chemistry and one or more additional subjects. This study aimed to determine whether studying a non-science subject for A-level is an independent predictor of achievement on the undergraduate medical course. Methods The subjects of this retrospective cohort study were 164 students from one entry-year group (October 2000), who progressed normally on the 5-year undergraduate medical course at Nottingham. Pre-admission academic and socio-demographic data and undergraduate course marks were obtained. T-test and hierarchical multiple linear regression analyses were undertaken to identify independent predictors of five course outcomes at different stages throughout the course. Results There was no evidence that the choice of science or non-science as the third or fourth A-level subject had any influence on course performance. Demographic variables (age group, sex, and fee status) had some predictive value but ethnicity did not. Pre-clinical course performance was the strongest predictor in the clinical phases (pre-clinical Themes A&B (knowledge) predicted Clinical Knowledge, p < 0.001, and pre-clinical Themes C&D (skills) predicted Clinical Skills, p = < 0.01). Conclusion This study of one year group at Nottingham Medical School provided no evidence that the admissions policy on A-level requirements should specify the choice of third or fourth subject. PMID:19159444

Do team processes really have an effect on clinical performance? A systematic literature review.

PubMed

Schmutz, J; Manser, T

2013-04-01

There is a growing literature on the relationship between team processes and clinical performance. The purpose of this review is to summarize these articles and examine the impact of team process behaviours on clinical performance. We conducted a literature search in five major databases. Inclusion criteria were: English peer-reviewed papers published between January 2001 and May 2012, which showed or tried to show (i) a statistical relationship of a team process variable and clinical performance or (ii) an improvement of a performance variable through a team process intervention. Study quality was assessed using predefined quality indicators. For every study, we calculated the relevant effect sizes. We included 28 studies in the review, seven of which were intervention studies. Every study reported at least one significant relationship between team processes or an intervention and performance. Also, some non-significant effects were reported. Most of the reported effect sizes were large or medium. The study quality ranged from medium to high. The studies are highly diverse regarding the specific team process behaviours investigated and also regarding the methods used. However, they suggest that team process behaviours do influence clinical performance and that training results in increased performance. Future research should rely on existing theoretical frameworks, valid, and reliable methods to assess processes such as teamwork or coordination and focus on the development of adequate tools to assess process performance, linking them with outcomes in the clinical setting.

[Support Team for Investigator-Initiated Clinical Research].

PubMed

Fujii, Hisako

2017-07-01

Investigator-initiated clinical research is that in which investigators plan and carry out their own clinical research in academia. For large-scale clinical research, a team should be organized and implemented. This team should include investigators and supporting staff, who will promote smooth research performance by fulfilling their respective roles. The supporting staff should include project managers, administrative personnel, billing personnel, data managers, and clinical research coordinators. In this article, I will present the current status of clinical research support and introduce the research organization of the Dominantly Inherited Alzheimer Network (DIAN) study, an investigator-initiated international clinical research study, with particular emphasis on the role of the project management staff and clinical research coordinators.

Experiences of undergraduate nursing students in peer assisted learning in clinical practice: a qualitative systematic review.

PubMed

Carey, Matthew C; Kent, Bridie; Latour, Jos M

2018-05-01

The objective of this qualitative systematic review was to identify and synthesize the best available evidence on experiences of peer assisted learning (PAL) among student nurses in clinical practice so as to understand the value of PAL for this population. Peer-assisted learning considers the benefits of peers working in collaboration and supporting each other in professional roles. This approach to facilitate learning is effective within universities, but there is limited exploration within the clinical practice environment. Within the UK, 50% of student nurses' learning is undertaken within clinical practice, providing a large portion of student allocation within these areas, but is unexplored in relation to PAL. Therefore, existing evidence examining PAL in clinical practice needs further exploration for a better understanding of its value to student nurses' learning. The systematic review considered studies that included male and female nursing students aged 18-50 years that explored undergraduate nursing students' experiences of PAL within the clinical practice environment. Studies that utilized designs such as phenomenology, grounded theory, ethnography, action research and feminist research were considered. Other text such as opinion papers and reports were to be considered if no qualitative studies could be located. The review excluded quantitative studies, as well as those addressing PAL outside the nursing profession and students within the nursing profession but not including undergraduate student nurses. This review considered studies that included aspects related to experiences of PAL in the clinical practice setting, as seen by undergraduate nursing students and the researcher. A three-step search strategy was undertaken to find both published and unpublished studies in English from 2003 to 2017 in various databases, and included searching of reference lists within articles selected for appraisal. Each of the included studies were assessed for methodological quality independently by two reviewers, using the Joanna Briggs Institute Critical Appraisal Form for Interpretive and Critical Research. Qualitative data was extracted using the standardized JBI qualitative data extraction tool. Qualitative research findings were synthesized using JBI methodology. From the eight included studies, 37 findings were extracted. These findings were further aggregated into seven categories, and then into three synthesized findings. These three synthesized findings are: 1) Challenges of clinical practice are mitigated by peer support; 2) Peers are role models for enhancing clinical knowledge; and 3) Support and feedback develop competence and confidence, and reduce stress and anxiety. Peer-assisted learning exists in clinical practice in both formal and informal circumstances. Friendship and community are often expressed as occurring when peers work together. Support and feedback help students develop in their clinical role and enhance clinical knowledge. Outcomes include enhancing the competency and confidence of peers, and reducing stress and anxiety. Challenges of clinical practice are mitigated through PAL.

Latinos with obsessive-compulsive disorder: Mental healthcare utilization and inclusion in clinical trials.

PubMed

Wetterneck, Chad T; Little, Tannah E; Rinehart, Kimberly L; Cervantes, Maritza E; Hyde, Emma; Williams, Monnica

2012-04-01

Previous research has documented that ethnic minorities, particularly Latinos, obtain fewer mental health services than Caucasians (Kearney, Draper, & Baron 2005; Sue, Fujino, Hu, Takeuchi, & Zane, 1991). Conceivably, this may be due to a wide array of cultural issues (e.g., negative stigma attached to mental health, and language, socio-economic, and acculturation barriers), symptom disparities across Caucasian and Latino groups, or lack of effective outreach methods by clinicians and researchers. However, research is limited. As a result, Latinos may be insufficiently represented in clinical studies for OCD, making it unclear whether evidence-based treatments demonstrate the same efficacy and effectiveness for Latinos as has been demonstrated for Caucasians. The current study takes an in-depth analysis of 98 efficacy and effectiveness studies for OCD from across the Western hemisphere and reports the rates of Latino inclusion from each sample. Ninety clinical studies in the US and Canada, as well as eight clinical studies in Mexico and Central America were reviewed. Findings showed that only 11 (24%) US and Canadian studies included Latino participants, illustrating an overwhelming underrepresentation of Latinos in clinical studies for OCD. Further explanation of the results and their implications are discussed, along with suggestions for effectively improving access to mental health research and appropriate treatments.

Latinos with obsessive-compulsive disorder: Mental healthcare utilization and inclusion in clinical trials

PubMed Central

Wetterneck, Chad T.; Little, Tannah E.; Rinehart, Kimberly L.; Cervantes, Maritza E.; Hyde, Emma; Williams, Monnica

2014-01-01

Previous research has documented that ethnic minorities, particularly Latinos, obtain fewer mental health services than Caucasians (Kearney, Draper, & Baron 2005; Sue, Fujino, Hu, Takeuchi, & Zane, 1991). Conceivably, this may be due to a wide array of cultural issues (e.g., negative stigma attached to mental health, and language, socio-economic, and acculturation barriers), symptom disparities across Caucasian and Latino groups, or lack of effective outreach methods by clinicians and researchers. However, research is limited. As a result, Latinos may be insufficiently represented in clinical studies for OCD, making it unclear whether evidence-based treatments demonstrate the same efficacy and effectiveness for Latinos as has been demonstrated for Caucasians. The current study takes an in-depth analysis of 98 efficacy and effectiveness studies for OCD from across the Western hemisphere and reports the rates of Latino inclusion from each sample. Ninety clinical studies in the US and Canada, as well as eight clinical studies in Mexico and Central America were reviewed. Findings showed that only 11 (24%) US and Canadian studies included Latino participants, illustrating an overwhelming underrepresentation of Latinos in clinical studies for OCD. Further explanation of the results and their implications are discussed, along with suggestions for effectively improving access to mental health research and appropriate treatments. PMID:29057210

Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

PubMed

Sennerby, L; Gottlow, J

2008-06-01

Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3).

Boric acid for recurrent vulvovaginal candidiasis: the clinical evidence.

PubMed

Iavazzo, Christos; Gkegkes, Ioannis D; Zarkada, Ioanna M; Falagas, Matthew E

2011-08-01

Recurrent vulvovaginal candidiasis (VVC) remains a challenge to manage in clinical practice. Recent epidemiologic studies indicate that non-albicans Candida spp. are more resistant to conventional antifungal treatment with azoles and are considered as causative pathogens of vulvovaginal candidiasis. We searched PubMed and Scopus for studies that reported clinical evidence on the intravaginal use of boric acid for vulvovaginal candidiasis. We identified 14 studies (2 randomized clinical trials [RCTs], 9 case series, and 4 case reports) as eligible for inclusion in this review. Boric acid was compared with nystatin, terconazole, flucytosine, itraconazole, clotrimazole, ketoconazole, fluconazole, buconazole, and miconazole; as monotherapy, boric acid was studied in 7 studies. The mycologic cure rates varied from 40% to 100% in patients treated with boric acid; 4 of the 9 included case series reported statistically significant outcomes regarding cure (both mycologic and clinical) rates. None of the included studies reported statistically significant differences in recurrence rates. Regarding the adverse effects caused by boric acid use, vaginal burning sensation (<10% of cases), water discharge during treatment, and vaginal erythema were identified in 7 studies. Our findings suggest that boric acid is a safe, alternative, economic option for women with recurrent and chronic symptoms of vaginitis when conventional treatment fails because of the involvement of non-albicans Candida spp. or azole-resistant strains.

From bench to bedside and to health policies: ethics in translational research.

PubMed

Petrini, C

2011-01-01

Translation of biomedical research knowledge to effective clinical treatment is essential to the public good. The first level of translation ("from bench to bedside") corresponds to efficacy studies under controlled conditions with careful attention to internal validity (clinical research). The second level is the translation of results from clinical studies into everyday clinical practice and health decision making. The article summarises the ethical issues involved in the translation of biomedical research advances to clinical applications and to clinical practice. In particular, the article synthesizes theory from clinical ethics, operational design, and philosophy to examine the unique bioethical issues raised by the recent focus on translational research. In this framework safety of study participants and balancing of risk due to treatment with the potential benefits of the research are crucial: in clinical research there is a danger that the emphasis on advancements in scientific knowledge might prevail over the protection of the people who participate in research. These issues involve basic scientists, clinicians and bioethicists because of their application to comparative effectiveness research, clinical trials and evidence-based medicine, as well basic biomedical research.

[Factors influencing nurses' clinical decision making--focusing on critical thinking disposition].

PubMed

Park, Seungmi; Kwon, In Gak

2007-10-01

The purpose of this study was to investigate the factors influencing nurses' clinical decision making focusing on critical thinking disposition. The subjects of this study consisted of 505 nurses working at one of the general hospitals located in Seoul. Data was collected by a self-administered questionnaire between December 2006 and January 2007. Data was analyzed by one way ANOVA, Pearson correlation coefficients, and stepwise multiple regression using SPSS Win 14.0. The mean scores of critical thinking disposition and clinical decision making were 99.10 and 134.32 respectively. Clinical decision making scores were significantly higher in groups under continuing education, with a master or higher degree, with clinical experience more than 5 years, or with experts. Critical thinking disposition and its subscales have a significant correlation with clinical decision making. Intellectual eagerness/curiosity, prudence, clinical experience, intellectual honesty, self-confidence, and healthy skepticism were important factors influencing clinical decision making(adjusted R(2)=33%). Results of this study suggest that various strategies such as retaining experienced nurses, encouraging them to continue with education and enhancing critical thinking disposition are warranted for development of clinical decision making.

Approaches using molecular imaging technology -- use of PET in clinical microdose studies.

PubMed

Wagner, Claudia C; Langer, Oliver

2011-06-19

Positron emission tomography (PET) imaging uses minute amounts of radiolabeled drug tracers and thereby meets the criteria for clinical microdose studies. The advantage of PET, when compared to other analytical methods used in microdose studies, is that the pharmacokinetics (PK) of a drug can be determined in the tissue targeted for drug treatment. PET microdosing already offers interesting applications in clinical oncology and in the development of central nervous system pharmaceuticals and is extending its range of application to many other fields of pharmaceutical medicine. Although requirements for preclinical safety testing for microdose studies have been cut down by regulatory authorities, radiopharmaceuticals increasingly need to be produced under good manufacturing practice (GMP) conditions, which increases the costs of PET microdosing studies. Further challenges in PET microdosing include combining PET with other ultrasensitive analytical methods, such as accelerator mass spectrometry (AMS), to gain plasma PK data of drugs, beyond the short PET examination periods. Finally, conducting clinical PET studies with radiolabeled drugs both at micro- and therapeutic doses is encouraged to answer the question of dose linearity in clinical microdosing. Copyright © 2010 Elsevier B.V. All rights reserved.

[Discussion on development of four diagnostic information scale for clinical re-evaluation of postmarketing herbs].

PubMed

He, Wei; Xie, Yanming; Wang, Yongyan

2011-12-01

Post-marketing re-evaluation of Chinese herbs can well reflect Chinese medicine characteristics, which is the most easily overlooked the clinical re-evaluation content. Since little attention has been paid to this, study on the clinical trial design method was lost. It is difficult to improving the effectiveness and safety of traditional Chinese medicine. Therefore, more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design, the study of Chinese medical information collection scale and statistical analysis methods, so as to improve the clinical trial design method study about tcm syndrome of Chinese herbs postmarketing re-evalutation status.

A Review of Collagen Cross-Linking in Cornea and Sclera

PubMed Central

Zhang, Xiao; Tao, Xiang-chen; Zhang, Jian; Li, Zhi-wei; Xu, Yan-yun; Wang, Yu-meng; Zhang, Chun-xiao; Mu, Guo-ying

2015-01-01

Riboflavin/UVA cross-linking is a technique introduced in the past decades for the treatment of keratoconus, keratectasia, and infectious keratitis. Its efficacy and safety have been investigated with clinical and laboratory studies since its first clinical application by Wollensak for the treatment of keratoconus. Although its complications are encountered during clinical practice, such as infection inducing risk, minimal invasion merits a further investigation on its future application in clinical practice. Recently, collagen cross-linking in sclera shows a promising prospect. In present study, we summarized the representative studies describing the clinical and laboratory application of collagen cross-linking published in past decades and provided our opinion on the positive and negative results of cross-linking in the treatment of ophthalmic disorders. PMID:25922758

Structured literature review of responses of cattle to viral and bacterial pathogens causing bovine respiratory disease complex.

PubMed

Grissett, G P; White, B J; Larson, R L

2015-01-01

Bovine respiratory disease (BRD) is an economically important disease of cattle and continues to be an intensely studied topic. However, literature summarizing the time between pathogen exposure and clinical signs, shedding, and seroconversion is minimal. A structured literature review of the published literature was performed to determine cattle responses (time from pathogen exposure to clinical signs, shedding, and seroconversion) in challenge models using common BRD viral and bacterial pathogens. After review a descriptive analysis of published studies using common BRD pathogen challenge studies was performed. Inclusion criteria were single pathogen challenge studies with no treatment or vaccination evaluating outcomes of interest: clinical signs, shedding, and seroconversion. Pathogens of interest included: bovine viral diarrhea virus (BVDV), bovine herpesvirus type 1 (BHV-1), parainfluenza-3 virus, bovine respiratory syncytial virus, Mannheimia haemolytica, Mycoplasma bovis, Pastuerella multocida, and Histophilus somni. Thirty-five studies and 64 trials were included for analysis. The median days to the resolution of clinical signs after BVDV challenge was 15 and shedding was not detected on day 12 postchallenge. Resolution of BHV-1 shedding resolved on day 12 and clinical signs on day 12 postchallenge. Bovine respiratory syncytial virus ceased shedding on day 9 and median time to resolution of clinical signs was on day 12 postchallenge. M. haemolytica resolved clinical signs 8 days postchallenge. This literature review and descriptive analysis can serve as a resource to assist in designing challenge model studies and potentially aid in estimation of duration of clinical disease and shedding after natural pathogen exposure. Copyright © 2015 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Clinical acceptability of metal-ceramic fixed partial dental prosthesis fabricated with direct metal laser sintering technique-5 year follow-up

PubMed Central

Prabhu, Radhakrishnan; Prabhu, Geetha; Baskaran, Eswaran; Arumugam, Eswaran M.

2016-01-01

Statement of Problem: In recent years, direct metal laser sintered (DMLS) metal-ceramic-based fixed partial denture prostheses have been used as an alternative to conventional metal-ceramic fixed partial denture prostheses. However, clinical studies for evaluating their long-term clinical survivability and acceptability are limited. Aims and Objective: The aim of this study was to assess the efficacy of metal-ceramic fixed dental prosthesis fabricated with DMLS technique, and its clinical acceptance on long-term clinical use. Materials and Methods: The study group consisted of 45 patients who were restored with posterior three-unit fixed partial denture prosthesis made using direct laser sintered metal-ceramic restorations. Patient recall and clinical examination of the restorations were done after 6months and every 12 months thereafter for the period of 60 months. Clinical examination for evaluation of longevity of restorations was done using modified Ryge criteria which included chipping of the veneered ceramic, connector failure occurring in the fixed partial denture prosthesis, discoloration at the marginal areas of the veneered ceramic, and marginal adaptation of the metal and ceramic of the fixed denture prosthesis. Periapical status was assessed using periodical radiographs during the study period. Survival analysis was made using the Kaplan–Meier method. Results: None of the patients had failure of the connector of the fixed partial denture prostheses during the study period. Two exhibited biological changes which included periapical changes and proximal caries adjacent to the abutments. Conclusion: DMLS metal-ceramic fixed partial denture prosthesis had a survival rate of 95.5% and yielded promising results during the 5-year clinical study. PMID:27141171

Low clinical diagnostic accuracy of early vs advanced Parkinson disease: clinicopathologic study.

PubMed

Adler, Charles H; Beach, Thomas G; Hentz, Joseph G; Shill, Holly A; Caviness, John N; Driver-Dunckley, Erika; Sabbagh, Marwan N; Sue, Lucia I; Jacobson, Sandra A; Belden, Christine M; Dugger, Brittany N

2014-07-29

Determine diagnostic accuracy of a clinical diagnosis of Parkinson disease (PD) using neuropathologic diagnosis as the gold standard. Data from the Arizona Study of Aging and Neurodegenerative Disorders were used to determine the predictive value of a clinical PD diagnosis, using 2 clinical diagnostic confidence levels, PossPD (never treated or not clearly responsive) and ProbPD (responsive to medications). Neuropathologic diagnosis was the gold standard. Based on first visit, 9 of 34 (26%) PossPD cases had neuropathologically confirmed PD while 80 of 97 (82%) ProbPD cases had confirmed PD. PD was confirmed in 8 of 15 (53%) ProbPD cases with <5 years of disease duration and 72 of 82 (88%) with ≥5 years of disease duration. Using final diagnosis at time of death, 91 of 107 (85%) ProbPD cases had confirmed PD. Clinical variables that improved diagnostic accuracy were medication response, motor fluctuations, dyskinesias, and hyposmia. Using neuropathologic findings of PD as the gold standard, this study establishes the novel findings of only 26% accuracy for a clinical diagnosis of PD in untreated or not clearly responsive subjects, 53% accuracy in early PD responsive to medication (<5 years' duration), and >85% diagnostic accuracy of longer duration, medication-responsive PD. Caution is needed when interpreting clinical studies of PD, especially studies of early disease that do not have autopsy confirmation. The need for a tissue or other diagnostic biomarker is reinforced. This study provides Class II evidence that a clinical diagnosis of PD identifies patients who will have pathologically confirmed PD with a sensitivity of 88% and specificity of 68%. © 2014 American Academy of Neurology.

Reducing the blame culture through clinical audit in nuclear medicine: a mixed methods study

PubMed Central

Ross, P; Hubert, J

2017-01-01

Objectives To identify the barriers and facilitators of doctors’ engagement with clinical audit and to explore how and why these factors influenced doctors’ decisions to engage with the NHS National Clinical Audit Programme. Design A single-embedded case study. Mixed methods sequential approach with explorative pilot study and follow-up survey. Pilot study comprised 13 semi-structured interviews with purposefully selected consultant doctors over a six-month period. Interview data coded and analysed using directed thematic content analysis with themes compared against the study’s propositions. Themes derived from the pilot study informed the online survey question items. Exploratory factor analysis using STATA and descriptive statistical methods applied to summarise findings. Data triangulation techniques used to corroborate and validate findings across the different methodological techniques. Setting NHS National PET-CT Clinical Audit Programme. Participants Doctors reporting on the Audit Programme. Main Outcome measures Extent of engagement with clinical audit, factors that influence engagement with clinical audit. Results Online survey: 58/59 doctors responded (98.3%). Audit was found to be initially threatening (79%); audit was reassuring (85%); audit helped validate professional competence (93%); participation in audit improved reporting skills (76%). Three key factors accounted for 97.6% of the variance in survey responses: (1) perception of audit’s usefulness, (2) a common purpose, (3) a supportive blame free culture of trust. Factor 1 influenced medical engagement most. Conclusions The study documents performance feedback as a key facilitator of medical engagement with clinical audit. It found that medical engagement with clinical audit was associated with reduced levels of professional anxiety and higher levels of perceived self-efficacy. PMID:28210493

A psychometric study of the Fear of Sleep Inventory-Short Form (FoSI-SF).

PubMed

Pruiksma, Kristi E; Taylor, Daniel J; Ruggero, Camilo; Boals, Adriel; Davis, Joanne L; Cranston, Christopher; DeViva, Jason C; Zayfert, Claudia

2014-05-15

Fear of sleep may play a significant role in sleep disturbances in individuals with posttraumatic stress disorder (PTSD). This report describes a psychometric study of the Fear of Sleep Inventory (FoSI), which was developed to measure this construct. The psychometric properties of the FoSI were examined in a non-clinical sample of 292 college students (Study I) and in a clinical sample of 67 trauma-exposed adults experiencing chronic nightmares (Study II). Data on the 23 items of the FoSI were subjected to exploratory factor analyses (EFA) to identify items uniquely assessing fear of sleep. Next, reliability and validity of a 13-item version of the FoSI was examined in both samples. A 13-item Short-Form version (FoSI-SF) was identified as having a clear 2-factor structure with high internal consistency in both the non-clinical (α = 0.76-0.94) and clinical (α = 0.88-0.91) samples. Both studies demonstrated good convergent validity with measures of PTSD (0.48-0.61) and insomnia (0.39-0.48) and discriminant validity with a measure of sleep hygiene (0.19-0.27). The total score on the FoSI-SF was significantly higher in the clinical sample (mean = 17.90, SD = 12.56) than in the non-clinical sample (mean = 4.80, SD = 7.72); t(357) = 8.85 p < 0.001. Although all items are recommended for clinical purposes, the data support the use of the 13-item FoSI-SF for research purposes. Replication of the factor structure in clinical samples is needed. Results are discussed in terms of limitations of this study and directions for further research.

Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms.

PubMed

Klein, Jan Philipp; Gamon, Carla; Späth, Christina; Berger, Thomas; Meyer, Björn; Hohagen, Fritz; Hautzinger, Martin; Lutz, Wolfgang; Vettorazzi, Eik; Moritz, Steffen; Schröder, Johanna

2017-07-13

This study aims to examine whether the effects of internet interventions for depression generalise to participants recruited in clinical settings. This study uses subgroup analysis of the results of a randomised, controlled, single-blind trial. The study takes place in five diagnostic centres in Germany. A total of 1013 people with mild to moderate depressive symptoms were recruited from clinical sources as well as internet forums, statutory insurance companies and other sources. This study uses either care-as-usual alone (control) or a 12-week internet intervention (Deprexis) plus usual care (intervention). The primary outcome measure was self-rated depression severity (Patient Health Questionnaire-9) at 3 months and 6 months. Further measures ranged from demographic and clinical parameters to a measure of attitudes towards internet interventions (Attitudes towards Psychological Online Interventions Questionnaire). The recruitment source was only associated with very few of the examined demographic and clinical characteristics. Compared with participants recruited from clinical sources, participants recruited through insurance companies were more likely to be employed. Clinically recruited participants were as severely affected as those from other recruitment sources but more sceptical of internet interventions. The effectiveness of the intervention was not differentially associated with recruitment source (treatment by recruitment source interaction=0.28, p=0.84). Our results support the hypothesis that the intervention we studied is effective across different recruitment sources including clinical settings. ClinicalTrials.gov NCT01636752. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Feasibility of studying brain morphology in major depressive disorder with structural magnetic resonance imaging and clinical data from the electronic medical record: A pilot study

PubMed Central

Hoogenboom, Wouter S.; Perlis, Roy H.; Smoller, Jordan W.; Zeng-Treitler, Qing; Gainer, Vivian S.; Murphy, Shawn N.; Churchill, Susanne E.; Kohane, Isaac S.; Shenton, Martha E.; Iosifescu, Dan V.

2012-01-01

For certain research questions related to long-term outcomes or to rare disorders, designing prospective studies is impractical or prohibitively expensive. Such studies could instead utilize clinical and magnetic resonance imaging data (MRI) collected as part of routine clinical care, stored in the electronic medical record (EMR). Using major depressive disorder (MDD) as a disease model, we examined the feasibility of studying brain morphology and associations with remission using clinical and MRI data exclusively drawn from the EMR. Advanced automated tools were used to select MDD patients and controls from the EMR who had brain MRI data, but no diagnosed brain pathology. MDD patients were further assessed for remission status by review of clinical charts. Twenty MDD patients (eight full-remitters, six partial-remitters, and six non-remitters), and fifteen healthy control subjects met all study criteria for advanced morphometric analyses. Compared to controls, MDD patients had significantly smaller right rostral-anterior cingulate volume, and level of non-remission was associated with smaller left hippocampus and left rostral-middle frontal gyrus volume. The use of EMR data for psychiatric research may provide a timely and cost-effective approach with the potential to generate large study samples reflective of the real population with the illness studied. PMID:23149041

Adapting Depression and Anxiety Questionnaire for Children into Turkish: Reliability and Validity Studies

ERIC Educational Resources Information Center

Ay, Ismail; Secer, Ismail; Simsek, Mustafa Kerim

2017-01-01

Purpose of this study is to adapt anxiety and depression questionnaire for children into Turkish culture and to analyze the psychometric characteristics of it on clinical and nonclinical samples separately. The study is a descriptive survey research. The study was conducted on two different sample groups, clinical and nonclinical. The clinical…

Understanding the Potential Interethnic Difference in Rosuvastatin Pharmacokinetics.

PubMed

Benet, Leslie Z; Wu, Hsin-Fang

2017-09-01

Here we address the potential difference in rosuvastatin pharmacokinetics in Asians vs. whites. Our prospective study, reported in this issue, shows no ethnic difference when all subjects are wild-type for OATP1B1 and BCRP. We argue that although our study may be under powered to prove no ethnic difference, and that further confirmatory study is required, the virtual clinical study analysis, also reported in this issue, does not contradict the results of our prospective clinical study and that previous retrospective analysis of clinical studies does not include enough relevant subjects to conclude that wild-type OATP1B1 and BCRP do still demonstrate ethnic differences. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval

DTIC Science & Technology

2016-10-01

consensus meeting, with input from investigators in the Prostate Cancer Clinical Trials Consortium, FDA Office of Oncology Drug Products, FDA Study...Cancer Clinical Trials Consortium, FDA Office of Oncology Drug Products, FDA Study Endpoint and Label Development Team, and FDA Division of...Abstract. American Society of Clinical Oncology . Chicago IL, June 1-5, 2013. INVENTIONS, PATENTS AND LICENSES None 11 REPORTABLE OUTCOMES

Evidence for an altered sex ratio in clinic-referred adolescents with gender dysphoria.

PubMed

Aitken, Madison; Steensma, Thomas D; Blanchard, Ray; VanderLaan, Doug P; Wood, Hayley; Fuentes, Amanda; Spegg, Cathy; Wasserman, Lori; Ames, Megan; Fitzsimmons, C Lindsay; Leef, Jonathan H; Lishak, Victoria; Reim, Elyse; Takagi, Anna; Vinik, Julia; Wreford, Julia; Cohen-Kettenis, Peggy T; de Vries, Annelou L C; Kreukels, Baudewijntje P C; Zucker, Kenneth J

2015-03-01

The number of adolescents referred to specialized gender identity clinics for gender dysphoria appears to be increasing and there also appears to be a corresponding shift in the sex ratio, from one favoring natal males to one favoring natal females. We conducted two quantitative studies to ascertain whether there has been a recent inversion of the sex ratio of adolescents referred for gender dysphoria. The sex ratio of adolescents from two specialized gender identity clinics was examined as a function of two cohort periods (2006-2013 vs. prior years). Study 1 was conducted on patients from a clinic in Toronto, and Study 2 was conducted on patients from a clinic in Amsterdam. Across both clinics, the total sample size was 748. In both clinics, there was a significant change in the sex ratio of referred adolescents between the two cohort periods: between 2006 and 2013, the sex ratio favored natal females, but in the prior years, the sex ratio favored natal males. In Study 1 from Toronto, there was no corresponding change in the sex ratio of 6,592 adolescents referred for other clinical problems. Sociological and sociocultural explanations are offered to account for this recent inversion in the sex ratio of adolescents with gender dysphoria. © 2015 International Society for Sexual Medicine.

Registered nurses' clinical reasoning skills and reasoning process: A think-aloud study.

PubMed

Lee, JuHee; Lee, Young Joo; Bae, JuYeon; Seo, Minjeong

2016-11-01

As complex chronic diseases are increasing, nurses' prompt and accurate clinical reasoning skills are essential. However, little is known about the reasoning skills of registered nurses. This study aimed to determine how registered nurses use their clinical reasoning skills and to identify how the reasoning process proceeds in the complex clinical situation of hospital setting. A qualitative exploratory design was used with a think-aloud method. A total of 13 registered nurses (mean years of experience=11.4) participated in the study, solving an ill-structured clinical problem based on complex chronic patients cases in a hospital setting. Data were analyzed using deductive content analysis. Findings showed that the registered nurses used a variety of clinical reasoning skills. The most commonly used skill was 'checking accuracy and reliability.' The reasoning process of registered nurses covered assessment, analysis, diagnosis, planning/implementation, and evaluation phase. It is critical that registered nurses apply appropriate clinical reasoning skills in complex clinical practice. The main focus of registered nurses' reasoning in this study was assessing a patient's health problem, and their reasoning process was cyclic, rather than linear. There is a need for educational strategy development to enhance registered nurses' competency in determining appropriate interventions in a timely and accurate fashion. Copyright © 2016 Elsevier Ltd. All rights reserved.

The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis.

PubMed

Mollayeva, Tatyana; Thurairajah, Pravheen; Burton, Kirsteen; Mollayeva, Shirin; Shapiro, Colin M; Colantonio, Angela

2016-02-01

This review appraises the process of development and the measurement properties of the Pittsburgh sleep quality index (PSQI), gauging its potential as a screening tool for sleep dysfunction in non-clinical and clinical samples; it also compares non-clinical and clinical populations in terms of PSQI scores. MEDLINE, Embase, PsycINFO, and HAPI databases were searched. Critical appraisal of studies of measurement properties was performed using COSMIN. Of 37 reviewed studies, 22 examined construct validity, 19 - known-group validity, 15 - internal consistency, and three - test-retest reliability. Study quality ranged from poor to excellent, with the majority designated fair. Internal consistency, based on Cronbach's alpha, was good. Discrepancies were observed in factor analytic studies. In non-clinical and clinical samples with known differences in sleep quality, the PSQI global scores and all subscale scores, with the exception of sleep disturbance, differed significantly. The best evidence synthesis for the PSQI showed strong reliability and validity, and moderate structural validity in a variety of samples, suggesting the tool fulfills its intended utility. A taxonometric analysis can contribute to better understanding of sleep dysfunction as either a dichotomous or continuous construct. Copyright © 2015 Elsevier Ltd. All rights reserved.

The costs, resource use and cost-effectiveness of Clinical Nurse Specialist–led interventions for patients with palliative care needs: A systematic review of international evidence

PubMed Central

Salamanca-Balen, Natalia; Seymour, Jane; Caswell, Glenys; Whynes, David; Tod, Angela

2017-01-01

Background: Patients with palliative care needs do not access specialist palliative care services according to their needs. Clinical Nurse Specialists working across a variety of fields are playing an increasingly important role in the care of such patients, but there is limited knowledge of the extent to which their interventions are cost-effective. Objectives: To present results from a systematic review of the international evidence on the costs, resource use and cost-effectiveness of Clinical Nurse Specialist–led interventions for patients with palliative care needs, defined as seriously ill patients and those with advanced disease or frailty who are unlikely to be cured, recover or stabilize. Design: Systematic review following PRISMA methodology. Data sources: Medline, Embase, CINAHL and Cochrane Library up to 2015. Studies focusing on the outcomes of Clinical Nurse Specialist interventions for patients with palliative care needs, and including at least one economic outcome, were considered. The quality of studies was assessed using tools from the Joanna Briggs Institute. Results: A total of 79 papers were included: 37 randomized controlled trials, 22 quasi-experimental studies, 7 service evaluations and other studies, and 13 economic analyses. The studies included a wide variety of interventions including clinical, support and education, as well as care coordination activities. The quality of the studies varied greatly. Conclusion: Clinical Nurse Specialist interventions may be effective in reducing specific resource use such as hospitalizations/re-hospitalizations/admissions, length of stay and health care costs. There is mixed evidence regarding their cost-effectiveness. Future studies should ensure that Clinical Nurse Specialists’ roles and activities are clearly described and evaluated. PMID:28655289

Using two on-going HIV studies to obtain clinical data from before, during and after pregnancy for HIV-positive women.

PubMed

Huntington, Susie E; Bansi, Loveleen K; Thorne, Claire; Anderson, Jane; Newell, Marie-Louise; Taylor, Graham P; Pillay, Deenan; Hill, Teresa; Tookey, Pat A; Sabin, Caroline A

2012-07-28

The UK Collaborative HIV Cohort (UK CHIC) is an observational study that collates data on HIV-positive adults accessing HIV clinical care at (currently) 13 large clinics in the UK but does not collect pregnancy specific data. The National Study of HIV in Pregnancy and Childhood (NSHPC) collates data on HIV-positive women receiving antenatal care from every maternity unit in the UK and Ireland. Both studies collate pseudonymised data and neither dataset contains unique patient identifiers. A methodology was developed to find and match records for women reported to both studies thereby obtaining clinical and treatment data on pregnant HIV-positive women not available from either dataset alone. Women in UK CHIC receiving HIV-clinical care in 1996-2009, were found in the NSHPC dataset by initially 'linking' records with identical date-of-birth, linked records were then accepted as a genuine 'match', if they had further matching fields including CD4 test date. In total, 2063 women were found in both datasets, representing 23.1% of HIV-positive women with a pregnancy in the UK (n = 8932). Clinical data was available in UK CHIC following most pregnancies (92.0%, 2471/2685 pregnancies starting before 2009). There was bias towards matching women with repeat pregnancies (35.9% (741/2063) of women found in both datasets had a repeat pregnancy compared to 21.9% (1502/6869) of women in NSHPC only) and matching women HIV diagnosed before their first reported pregnancy (54.8% (1131/2063) compared to 47.7% (3278/6869), respectively). Through the use of demographic data and clinical dates, records from two independent studies were successfully matched, providing data not available from either study alone.

Medicinal Mushrooms in Human Clinical Studies. Part I. Anticancer, Oncoimmunological, and Immunomodulatory Activities: A Review.

PubMed

Wasser, Solomon P

2017-01-01

More than 130 medicinal functions are thought to be produced by medicinal mushrooms (MMs) and fungi, including antitumor, immunomodulating, antioxidant, radical scavenging, cardiovascular, antihypercholesterolemic, antiviral, antibacterial, antiparasitic, antifungal, detoxification, hepatoprotective, antidiabetic, and other effects. Many, if not all, higher Basidiomycetes mushrooms contain biologically active compounds in fruit bodies, cultured mycelia, and cultured broth. Special attention has been paid to mushroom polysaccharides. Numerous bioactive polysaccharides or polysaccharide-protein complexes from MMs seem to enhance innate and cell-mediated immune responses, and they exhibit antitumor activities in animals and humans. While the mechanism of their antitumor actions is still not completely understood, stimulation and modulation of key host immune responses by these mushroom compounds seems to be central. Most important for modern medicine are polysaccharides and low-molecular weight secondary metabolites with antitumor and immunostimulating properties. More than 600 studies have been conducted worldwide, and numerous human clinical trials on MMs have been published. Several of the mushroom compounds have proceeded through phase I, II, and III clinical studies and are used extensively and successfully in Asia to treat various cancers and other diseases. The aim of this review is to provide an overview of and analyze the literature on clinical trials using MMs with human anticancer, oncoimmunological, and immunomodulatory activities. High-quality, long-term, randomized, double-blind, placebo-controlled clinical studies of MMs, including well-sized population studies are definitely needed in order to yield statistical power showing their efficacy and safety. Clinical trials must obtain sufficient data on the efficacy and safety of MM-derived drugs and preparations. Discussion of results based on clinical studies of the anticancer, oncoimmunological, and immunomodulating activity of MMs are highlighted. Epidemiological studies with MMs are also discussed.

Availability and Use of Shared Data From Cardiometabolic Clinical Trials.

PubMed

Vaduganathan, Muthiah; Nagarur, Amulya; Qamar, Arman; Patel, Ravi B; Navar, Ann Marie; Peterson, Eric D; Bhatt, Deepak L; Fonarow, Gregg C; Yancy, Clyde W; Butler, Javed

2018-02-27

Sharing of patient-level clinical trial data has been widely endorsed. Little is known about how extensively these data have been used for cardiometabolic diseases. We sought to evaluate the availability and use of shared data from cardiometabolic clinical trials. We extracted data from ClinicalStudyDataRequest.com, a large, multisponsor data-sharing platform hosting individual patient-level data from completed studies sponsored by 13 pharmaceutical companies. From January 2013 to May 2017, the platform had data from 3374 clinical trials, of which 537 (16%) evaluated cardiometabolic therapeutics (phase 1, 36%; phase 2, 17%; phase 2/3, 1%; phase 3, 42%; phase 4, 4%). They covered 74 therapies and 398 925 patients. Diabetes mellitus (60%) and hypertension (15%) were the most common study topics. Median time from study completion to data availability was 79 months. As of May 2017, ClinicalStudyDataRequest.com had received 318 submitted proposals, of which 163 had signed data-sharing agreements. Thirty of these proposals were related to cardiometabolic therapies and requested data from 79 unique studies (15% of all trials, 29% of phase 3/4 trials). Most (96%) data requesters of cardiometabolic clinical trial data were from academic centers in North America and Western Europe, and half the proposals were unfunded. Most proposals were for secondary hypothesis-generating questions, with only 1 proposed reanalysis of the original study primary hypothesis. To date, 3 peer-reviewed articles have been published after a median of 19 months (9-32 months) from the data-sharing agreement. Despite availability of data from >500 cardiometabolic trials in a multisponsor data-sharing platform, only 15% of these trials and 29% of phase 3/4 trials have been accessed by investigators thus far, and a negligible minority of analyses have reached publication. © 2017 American Heart Association, Inc.

Trends in Research with U.S. Military Service Member Participants: A Population-Specific ClinicalTrials.gov Review.

PubMed

Cook, Wendy A; Doorenbos, Ardith Z; Bridges, Elizabeth J

2016-08-15

ClinicalTrials.gov reviews have evaluated research trends for specific conditions and age groups but not for specific populations of research participants. No ClinicalTrials.gov reviews have evaluated research with military service member participants. Study objectives were (a) to use ClinicalTrials.gov to identify trends in biomedical research from 2005 to 2014 in which U.S. military service members actively participated as research participants and (b) to describe a search strategy for adaptation in future ClinicalTrials.gov reviews of specific participant populations. A systematic review of ClinicalTrials.gov was performed to identify studies that included U.S. service members as participants, either exclusively or with other groups of participants. U.S. service members were identified as participants in 512 studies. Service members participated together with other groups in 392 studies, while 120 studies included only service members. The top five conditions of interest were post-traumatic stress disorder, traumatic brain injury, amputations, burns, and ocular injuries/disorders. The number of studies started each year peaked in 2011 and declined from 2012 to 2014. Twenty-five percent of studies exclusive to service members aimed to enroll 500 or more participants. Research exclusive to Guard and Reserve service members during this period was limited. U.S. military service members participate in biomedical research. To address the health needs of U.S. service members, it is important to ensure there is not a prolonged decline in research among this population. The search strategy may be adapted to ClinicalTrials.gov reviews of specific participant populations for which straightforward searches are not possible.

Spine device clinical trials: design and sponsorship.

PubMed

Cher, Daniel J; Capobianco, Robyn A

2015-05-01

Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (p<.0001) and larger sample sizes. There were very few US-based multicenter randomized trials of spine devices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical correlates of co-occurring cannabis and tobacco use: a systematic review.

PubMed

Peters, Erica N; Budney, Alan J; Carroll, Kathleen M

2012-08-01

  A growing literature has documented the substantial prevalence of and putative mechanisms underlying co-occurring (i.e. concurrent or simultaneous) cannabis and tobacco use. Greater understanding of the clinical correlates of co-occurring cannabis and tobacco use may suggest how intervention strategies may be refined to improve cessation outcomes and decrease the public health burden associated with cannabis and tobacco use.   A systematic review of the literature on clinical diagnoses, psychosocial problems and outcomes associated with co-occurring cannabis and tobacco use. Twenty-eight studies compared clinical correlates in co-occurring cannabis and tobacco users versus cannabis- or tobacco-only users. These included studies of treatment-seekers in clinical trials and non-treatment-seekers in cross-sectional or longitudinal epidemiological or non-population-based surveys.   Sixteen studies examined clinical diagnoses, four studies examined psychosocial problems and 11 studies examined cessation outcomes in co-occurring cannabis and tobacco users (several studies examined multiple clinical correlates). Relative to cannabis use only, co-occurring cannabis and tobacco use was associated with a greater likelihood of cannabis use disorders, more psychosocial problems and poorer cannabis cessation outcomes. Relative to tobacco use only, co-occurring use did not appear to be associated consistently with a greater likelihood of tobacco use disorders, more psychosocial problems or poorer tobacco cessation outcomes.   Cannabis users who also smoke tobacco are more dependent on cannabis, have more psychosocial problems and have poorer cessation outcomes than those who use cannabis but not tobacco. The converse does not appear to be the case. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

Psychometric properties and clinical cut-off scores of the Spanish version of the Social Anxiety Scale for Adolescents.

PubMed

Garcia-Lopez, Luis J; Inglés, Cándido J; García-Fernández, José M; Hidalgo, María D; Bermejo, Rosa; Puklek Levpušček, Melita

2011-01-01

This study examined the reliability and validity evidence drawn from the scores of the Spanish version of the Slovenian-developed Social Anxiety Scale for Adolescents (SASA; Puklek, 1997; Puklek & Vidmar, 2000) using a community sample (Study 1) and a clinical sample (Study 2). Confirmatory factor analysis in Study 1 replicated the 2-factor structure found by the original authors in a sample of Slovenian adolescents. Test-retest reliability was adequate. Furthermore, the SASA correlated significantly with other social anxiety scales, supporting concurrent validity evidence in Spanish adolescents. The results of Study 2 confirmed the correlations between the SASA and other social anxiety measures in a clinical sample. In addition, findings revealed that the SASA can effectively discriminate between adolescents with a clinical diagnosis of social anxiety disorder (SAD) and those without this disorder. Finally, cut-off scores for the SASA are provided for Spanish adolescents.

Scientific ways to study intercessory prayer as an intervention in clinical research.

PubMed

Rath, Linda L

2009-01-01

The purpose of this article is to share a "research journey" to study the somewhat controversial subject of Christian intercessory prayer (CIP) utilized as a clinical intervention, and the knowledge gained along the way. This article will explore the steps in the development and implementation of clinical research to scientifically examine a phenomenon that many say cannot--and should not--be studied. The sequential steps in developing this area of study are detailed and explained from the conception of the initial idea through utilization of concept analysis and literature review to develop the researchable topic. The subsequent development of both qualitative and quantitative pilot studies to investigate CIP in depth is presented to illustrate how the intervention of CIP can successfully be incorporated into clinical research. This article provides guidelines for future researchers who may want to utilize CIP as an intervention.

21 CFR 54.1 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-04-01

... steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize... INVESTIGATORS § 54.1 Purpose. (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in... clinical studies to determine whether the applications are approvable under the statutory requirements. FDA...

21 CFR 54.1 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-04-01

... steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize... INVESTIGATORS § 54.1 Purpose. (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in... clinical studies to determine whether the applications are approvable under the statutory requirements. FDA...

What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

PubMed

Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2012-06-01

In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Clinical skills development in student-run free clinic volunteers: a multi-trait, multi-measure study.

PubMed

Nakamura, Mio; Altshuler, David; Chadwell, Margit; Binienda, Juliann

2014-12-12

At Wayne State University School of Medicine (WSU SOM), the Robert R. Frank Student Run Free Clinic (SRFC) is one place preclinical students can gain clinical experience. There have been no published studies to date measuring the impact of student-run free clinic (SRFC) volunteerism on clinical skills development in preclinical medical students. Surveys were given to first year medical students at WSU SOM at the beginning and end of Year 1 to assess perception of clinical skills, including self-confidence, self-reflection, and professionalism. Scores of the Year 1 Objective Structured Clinical Exam (OSCE) were compared between SRFC volunteers and non-volunteers. There were a total of 206 (68.2%) and 80 (26.5%) survey responses at the beginning and end of Year 1, respectively. Of the 80 students, 31 (38.7%) volunteered at SRFC during Year 1. Statistically significant differences were found between time points in self-confidence (p < 0.001) in both groups. When looking at self-confidence in skills pertaining to SRFC, the difference between groups was statistically significant (p = 0.032) at both time points. A total of 302 students participated in the Year 1 OSCE, 27 (9%) of which were SRFC volunteers. No statistically significant differences were found between groups for mean score (p = 0.888) and established level of rapport (p = 0.394). While this study indicated no significant differences in clinical skills in students who volunteer at the SRFC, it is a first step in attempting to measure clinical skill development outside of the structured medical school setting. The findings lend themselves to development of research designs, clinical surveys, and future studies to measure the impact of clinical volunteer opportunities on clinical skills development in future physicians.

Nurse teacher models in clinical education from the perspective of student nurses--A mixed method study.

PubMed

Gustafsson, Margareta; Kullén Engström, Agneta; Ohlsson, Ulla; Sundler, Annelie J; Bisholt, Birgitta

2015-12-01

The aim was to describe and compare the clinical teacher's role in different models of clinical practice from the perspective of student nurses. The study took place in collaboration with two Swedish universities that applied different educational models in clinical practice. A mixed method approach was used. The quantitative part had a comparative design and the qualitative part had a descriptive design. The study group consisted of 114 student nurses (response rate 87%). Fifty-three of them had met clinical teachers employed at the university and not participating in the daily clinical work (University Nurse Teachers, UNTs), whilst 61 had met clinical teachers dividing their time between teaching and nursing (Clinical Nurse Teachers, CNTs). Eight students participated in the qualitative part of the study. A questionnaire including the CLES+T scale was used to ascertain the students' perception of the clinical teacher's role, complemented by interviews directed towards an enrichment of this perception. Students meeting CNTs agreed more strongly than those meeting UNTs that the teacher had the ability to help them integrate theory and practice. Whilst spontaneous meetings between students and CNTs occurred, students mostly met UNTs in seminars. Students meeting UNTs felt alone but did appreciate having someone outside the clinical environment to provide support if they did not get along with their preceptor. In the case of UNTs, it is important that they keep their knowledge of clinical issues updated and visit the clinical placement not only for seminars but also to give students emotional support. In the case of CNTs, it is important that they are members of the faculty at the university, take part in the planning of the clinical courses and are able to explain the learning goals to the students. Copyright © 2015 Elsevier Ltd. All rights reserved.

Randomized clinical trials and observational studies in the assessment of drug safety.

PubMed

Sawchik, J; Hamdani, J; Vanhaeverbeek, M

2018-05-01

Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines' safety profile. In addition, we present general recommendations for the sensible use of observational data. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Nursing Challenges in Motivating Nursing Students through Clinical Education: A Grounded Theory Study.

PubMed

Nasrin, Hanifi; Soroor, Parvizy; Soodabeh, Joolaee

2012-01-01

Nurses are the first role models for students in clinical settings. They can have a significant role on students' motivation. The purpose of this study was to explore the understanding of nursing students and instructors concerning the role of nurses in motivating nursing students through clinical education. The sampling was first started purposefully and continued with theoretical sampling. The study collected qualitative data through semistructured and interactive interviews with 16 nursing students and 4 nursing instructors. All interviews were recorded, transcribed, and analyzed using grounded theory approach. One important pattern emerged in this study was the "concerns of becoming a nurse," which itself consisted of three categories: "nurses clinical competency," "nurses as full-scale mirror of the future," and "Monitoring and modeling through clinical education" (as the core variable). The findings showed that the nurses' manners of performance as well as the profession's prospect have a fundamental role in the process of formation of motivation through clinical education. Students find an insight into the nursing profession by substituting themselves in the place of a nurse, and as result, are or are not motivated towards the clinical education.

Clinical outcomes research in gynecologic oncology.

PubMed

Melamed, Alexander; Rauh-Hain, J Alejandro; Schorge, John O

2017-09-01

Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology. Copyright © 2017. Published by Elsevier Inc.

How characteristic routines of clinical departments influence students' self-regulated learning: A grounded theory study.

PubMed

Berkhout, J J; Slootweg, I A; Helmich, E; Teunissen, P W; van der Vleuten, C P M; Jaarsma, A D C

2017-11-01

In clerkships, students are expected to self-regulate their learning. How clinical departments and their routine approach on clerkships influences students' self-regulated learning (SRL) is unknown. This study explores how characteristic routines of clinical departments influence medical students' SRL. Six focus groups including 39 purposively sampled participants from one Dutch university were organized to study how characteristic routines of clinical departments influenced medical students' SRL from a constructivist paradigm, using grounded theory methodology. The focus groups were audio recorded, transcribed verbatim and were analyzed iteratively using constant comparison and open, axial and interpretive coding. Students described that clinical departments influenced their SRL through routines which affected the professional relationships they could engage in and affected their perception of a department's invested effort in them. Students' SRL in a clerkship can be supported by enabling them to engage others in their SRL and by having them feel that effort is invested in their learning. Our study gives a practical insight in how clinical departments influenced students' SRL. Clinical departments can affect students' motivation to engage in SRL, influence the variety of SRL strategies that students can use and how meaningful students perceive their SRL experiences to be.

Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study.

PubMed

Ramagopalan, Sreeram V; Skingsley, Andrew P; Handunnetthi, Lahiru; Magnus, Daniel; Klingel, Michelle; Pakpoor, Julia; Goldacre, Ben

2015-01-01

We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome .  Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

Electronic health records to facilitate clinical research.

PubMed

Cowie, Martin R; Blomster, Juuso I; Curtis, Lesley H; Duclaux, Sylvie; Ford, Ian; Fritz, Fleur; Goldman, Samantha; Janmohamed, Salim; Kreuzer, Jörg; Leenay, Mark; Michel, Alexander; Ong, Seleen; Pell, Jill P; Southworth, Mary Ross; Stough, Wendy Gattis; Thoenes, Martin; Zannad, Faiez; Zalewski, Andrew

2017-01-01

Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.

Advances in clinical study of curcumin.

PubMed

Yang, Chunfen; Su, Xun; Liu, Anchang; Zhang, Lin; Yu, Aihua; Xi, Yanwei; Zhai, Guangxi

2013-01-01

Curcumin has been estimated as a potential agent for many diseases and attracted great attention owing to its various pharmacological activities, including anti-cancer, and anti-inflammatory. Now curcumin is being applied to a number of patients with breast cancer, rheumatoid arthritis, Alzheimer's disease, colorectal cancer, psoriatic, etc. Several clinical trials have stated that curcumin is safe enough and effective. The objective of this article was to summarize the clinical studies of curcumin, and give a reference for future studies.

Biosimilars for psoriasis: clinical studies to determine similarity.

PubMed

Blauvelt, A; Puig, L; Chimenti, S; Vender, R; Rajagopalan, M; Romiti, R; Skov, L; Zachariae, C; Young, H; Prens, E; Cohen, A; van der Walt, J; Wu, J J

2017-07-01

Biosimilars are drugs that are similar, but not identical, to originator biologics. Preclinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to determining biosimilarity. In this review, written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability and optimal clinical trial design. © 2016 British Association of Dermatologists.

Is the Construct of Relapse Heuristic, and Does It Advance Alcohol Use Disorder Clinical Practice?

PubMed Central

Maisto, Stephen A.; Witkiewitz, Katie; Moskal, Dezarie; Wilson, Adam D.

2016-01-01

Objective: Alcohol use disorder (AUD) relapse is a construct that has been of major clinical and research interest but has been inconsistently defined. The purpose of this study was to review the definitions of AUD relapse that have been used in clinical research as a basis for drawing conclusions about its heuristic value. Method: A systematic review of the literature was conducted on empirical studies that (a) were published in peer-reviewed journals, (b) were published between 2010 and 2015, (c) were written in English, and (d) provided a definition of alcohol relapse (or lapse) that was used in the study. Results: The review yielded 139 individual studies that met inclusion criteria. The studies showed wide variability in how relapse was defined and interpreted in the literature, and there was little direct empirical or theoretical rationale provided for the definitions of relapse that were chosen. Furthermore, the concept of AUD relapse as a discrete state is not consistent with the empirical literature on the clinical course of alcohol consumption. Conclusions: We conclude that the heuristic value of AUD relapse as currently studied is low. An alternative approach that embeds the construct in theory and data on the clinical course of alcohol consumption and aligns with current trends in healthcare would seem to have a better chance of improving AUD clinical decision-making and knowledge about AUD in general. PMID:27797685

Is the Construct of Relapse Heuristic, and Does It Advance Alcohol Use Disorder Clinical Practice?

PubMed

Maisto, Stephen A; Witkiewitz, Katie; Moskal, Dezarie; Wilson, Adam D

2016-11-01

Alcohol use disorder (AUD) relapse is a construct that has been of major clinical and research interest but has been inconsistently defined. The purpose of this study was to review the definitions of AUD relapse that have been used in clinical research as a basis for drawing conclusions about its heuristic value. A systematic review of the literature was conducted on empirical studies that (a) were published in peer-reviewed journals, (b) were published between 2010 and 2015, (c) were written in English, and (d) provided a definition of alcohol relapse (or lapse) that was used in the study. The review yielded 139 individual studies that met inclusion criteria. The studies showed wide variability in how relapse was defined and interpreted in the literature, and there was little direct empirical or theoretical rationale provided for the definitions of relapse that were chosen. Furthermore, the concept of AUD relapse as a discrete state is not consistent with the empirical literature on the clinical course of alcohol consumption. We conclude that the heuristic value of AUD relapse as currently studied is low. An alternative approach that embeds the construct in theory and data on the clinical course of alcohol consumption and aligns with current trends in healthcare would seem to have a better chance of improving AUD clinical decision-making and knowledge about AUD in general.

Transferring Exome Sequencing Data from Clinical Laboratories to Healthcare Providers: Lessons Learned at a Pediatric Hospital

PubMed Central

Swaminathan, Rajeswari; Huang, Yungui; Miller, Katherine; Pastore, Matthew; Hashimoto, Sayaka; Jacobson, Theodora; Mouhlas, Danielle; Lin, Simon

2018-01-01

The adoption rate of genome sequencing for clinical diagnostics has been steadily increasing leading to the possibility of improvement in diagnostic yields. Although laboratories generate a summary clinical report, sharing raw genomic data with healthcare providers is equally important, both for secondary research studies as well as for a deeper analysis of the data itself, as seen by the efforts from organizations such as American College of Medical Genetics and Genomics and Global Alliance for Genomics and Health. Here, we aim to describe the existing protocol of genomic data sharing between a certified clinical laboratory and a healthcare provider and highlight some of the lessons learned. This study tracked and subsequently evaluated the data transfer workflow for 19 patients, all of whom consented to be part of this research study and visited the genetics clinic at a tertiary pediatric hospital between April 2016 to December 2016. Two of the most noticeable elements observed through this study are the manual validation steps and the discrepancies in patient identifiers used by a clinical lab vs. healthcare provider. Both of these add complexity to the transfer process as well as make it more susceptible to errors. The results from this study highlight some of the critical changes that need to be made in order to improve genomic data sharing workflows between healthcare providers and clinical sequencing laboratories. PMID:29515625

Pre-clinical and Clinical Safety Studies of CMX-2043: A Cytoprotective Lipoic Acid Analogue for Ischaemia–Reperfusion Injury

PubMed Central

Kates, Steven A; Lader, Alan S; Casale, Ralph; Beeuwkes, Reinier

2014-01-01

CMX-2043 is an α-lipoic acid analogue targeted to reduction of cellular injury and organ damage due to ischaemia–reperfusion injury (IRI). It has been shown to be effective in a rat model of cardiac IRI. The studies here reported evaluate its safety and pharmacokinetic profile in preparation for human clinical studies in procedures associated with IRI. Safety and tolerability were tested in standard pre-clinical in vitro and animal models and in a Phase 1 human clinical trial. CMX-2043 did not bind to a wide range of receptors and specific targets at approximately 4 μg/mL (10 μM). It was not mutagenic by Ames assay, did not produce chromosome aberrations in Chinese hamster ovary (CHO) cells, and was negative for clastogenic potential. Toxicological studies in rats including both single and 14-day repeat intravenous doses and in dogs (single intravenous dose) with a 2-week recovery period were conducted. The NOAEL in rats and dogs was 30 and >10 mg/kg, respectively. No serious adverse events were reported in a placebo-controlled, sequential dose escalation Phase 1 clinical trial. The low toxicity in the pre-clinical studies and the absence of adverse events in the Phase 1 trial have supported investigation of CMX-2043 in a human efficacy trial. PMID:24751172

[Outlook for clinical hemorheology].

PubMed

Stoltz, J F

1996-01-01

Harvey may be considered to be the precursor of modern hemorheology, but it was not until the pioneering work of Loewenhoeck, Poiseuille, Fahraeus and Copley that the essential role of the hemorheological properties of blood and its cellular components was recognized. Before the advent of modern hemorheology in the 70s, studies were mainly focussed on microcirculation and validation of global hemorheological equations applied to blood circulation. Parallel studies on the microrheological properties (erythrocyte deformability and aggregation) explained analytically the non-Newtonian behavior of blood, and the essential contribution of these parameters to the understanding hyperviscosity syndromes. The development of clinical hemorheology in fact started at the international conferences held in Reykjavik (1966) and Heidelberg (1969), and with the initiation of the periodical European Microcirculation (since Nancy in 1960) and Clinical Hemorheology (since Nancy in 1979) Conferences. The current main avenues of research involve flow modelling, studies of cell-cell interaction mechanisms (aggregation and adhesion), in relation to the associated pathophysiological phenomena, such as cellular activation (platelets and leukocytes in particular), gene expression linked to blood flow (e.g. endothelial cells)... Clinically and therapeutically, it is crucial that pathophysiological studies be undertaken on the relationship existing between rheological parameters and objective clinical data (local flow rates, ischemic markers, hemostatic parameters, tissue oxygen, clinical symptoms,...). The main clinical application fields are cardiovascular diseases, thrombosis, diabetes, hypercholesterolemia... Also, studies on new therapeutics or on biomaterials should also be given priority.

The design and methodology of premature ejaculation interventional studies

PubMed Central

2016-01-01

Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials. PMID:27652224

Impact of the clinical Pilates exercises and verbal education on exercise beliefs and psychosocial factors in healthy women.

PubMed

Küçük, Fadime; Livanelioglu, Ayşe

2015-11-01

[Purpose] Exercise is one of the most important components of a healthy life. The purpose of this study was to analyze exercise beliefs and psychosocial factors in sedentary and active healthy women and observe the changes in these parameters resulting from clinical Pilates exercises and verbal education in healthy women. [Subjects and Methods] Sixty-six healthy women were included in the study. Participants were divided into clinical Pilates (n=21), verbal education (n=25), and control groups (n=20). Prior to and at the end of the study, demographic information, body mass index, waist-hip circumference, exercise beliefs, physical activity index, and psychosocial factors (Rosenberg self-esteem scale, Body Cathexis Index, SF-36 quality of life, Beck Depression Scale, visual analog scale for tiredness) of the subjects were recorded. [Results] Meaningful changes for all the parameters took place in the clinical Pilates and verbal education groups. Our analyses indicated that the changes in the clinical Pilates group were more meaningful than those in the verbal education group. When the data of the study groups were compared with those of the control group, the clinical Pilates group showed meaningful differences. [Conclusion] The result of this study indicate that both clinical Pilates and verbal education are effective in changing exercise beliefs and physical and psychosocial parameters.

Clinical handover practices in maternity services in Ireland: A qualitative descriptive study.

PubMed

Fealy, Gerard; Munroe, Deirdre; Riordan, Fiona; Croke, Eilish; Conroy, Celine; McNamara, Martin; Shannon, Michael

2016-08-01

the objective was to examine and describe clinical handover practices in Irish maternity services. the study design incorporated interviews and focus group discussions with a purposive sample of healthcare practitioners working in Irish maternity services. five maternity hospitals and fourteen co-located maternity units. midwives, obstetricians and other healthcare professionals, specifically physiotherapists and radiologists, midwifery students and health care assistants working in maternity services. the study participants provided nuanced and differentiated accounts of clinical handover practices, which indicated a general absence of formal policy and training on clinical handover and the practice of midwifery and medical teams holding separate clinical handovers based on their separate, respective needs for transferring information and clinical responsibility. Participants spoke of barriers to effective clinical handover, including unsuitable environments, lack of dedicated time and fatigue during duty shift clinical handover, lack of supportive information technology (IT) infrastructure, and resistance of some staff to the adoption of new technologies to support clinical handover. whether internal and external to clinical handover events, the barriers to effective clinical handover represent threats to patient safety and quality of care, since effective clinical handover is essential to the provision of safe quality care. clear and effective communication between collaborating professionals within maternity teams is essential. Copyright © 2016 Elsevier Ltd. All rights reserved.

Clinical manifestations of tension pneumothorax: protocol for a systematic review and meta-analysis

PubMed Central

2014-01-01

Background Although health care providers utilize classically described signs and symptoms to diagnose tension pneumothorax, available literature sources differ in their descriptions of its clinical manifestations. Moreover, while the clinical manifestations of tension pneumothorax have been suggested to differ among subjects of varying respiratory status, it remains unknown if these differences are supported by clinical evidence. Thus, the primary objective of this study is to systematically describe and contrast the clinical manifestations of tension pneumothorax among patients receiving positive pressure ventilation versus those who are breathing unassisted. Methods/Design We will search electronic bibliographic databases (MEDLINE, PubMed, EMBASE, and the Cochrane Database of Systematic Reviews) and clinical trial registries from their first available date as well as personal files, identified review articles, and included article bibliographies. Two investigators will independently screen identified article titles and abstracts and select observational (cohort, case–control, and cross-sectional) studies and case reports and series that report original data on clinical manifestations of tension pneumothorax. These investigators will also independently assess risk of bias and extract data. Identified data on the clinical manifestations of tension pneumothorax will be stratified according to whether adult or pediatric study patients were receiving positive pressure ventilation or were breathing unassisted, as well as whether the two investigators independently agreed that the clinical condition of the study patient(s) aligned with a previously published tension pneumothorax working definition. These data will then be summarized using a formal narrative synthesis alongside a meta-analysis of observational studies and then case reports and series where possible. Pooled or combined estimates of the occurrence rate of clinical manifestations will be calculated using random effects models (for observational studies) and generalized estimating equations adjusted for reported potential confounding factors (for case reports and series). Discussion This study will compile the world literature on tension pneumothorax and provide the first systematic description of the clinical manifestations of the disorder according to presenting patient respiratory status. It will also demonstrate a series of methods that may be used to address difficulties likely to be encountered during the conduct of a meta-analysis of data contained in published case reports and series. PROSPERO registration number: CRD42013005826. PMID:24387082

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial.

PubMed

Acri, Mary; Hamovitch, Emily; Mini, Maria; Garay, Elene; Connolly, Claire; McKay, Mary

2017-12-04

Oppositional defiant disorder (ODD) is a major mental health concern and highly prevalent among children living in poverty-impacted communities. Despite that treatments for ODD are among the most effective, few children living in poverty receive these services due to substantial barriers to access, as well as difficulties in the uptake and sustained adoption of evidence-based practices (EBPs) in community settings. The purpose of this study is to examine implementation processes that impact uptake of an evidence-based practice for childhood ODD, and the impact of a Clinic Implementation Team (CIT)-driven structured adaptation to enhance its fit within the public mental health clinic setting. This study, a Hybrid Type II effectiveness-implementation research trial, blends clinical effectiveness and implementation research methods to examine the impact of the 4Rs and 2Ss Multiple Family Group (MFG) intervention, family level mediators of child outcomes, clinic/provider-level mediators of implementation, and the impact of CITs on uptake and long-term utilization of this model. All New York City public outpatient mental health clinics have been invited to participate. A sampling procedure that included randomization at the agency level and a sub-study to examine the impact of clinic choice upon outcomes yielded a distribution of clinics across three study conditions. Quantitative data measuring child outcomes, organizational factors and implementation fidelity will be collected from caregivers and providers at baseline, 8, and 16 weeks from baseline, and 6 months from treatment completion. The expected participation is 134 clinics, 268 providers, and 2688 caregiver/child dyads. We will use mediation analysis with a multi-level Structural Equation Modeling (SEM) (MSEM including family level variables, provider variables, and clinic variables), as well as mediation tests to examine study hypotheses. The aim of the study is to generate knowledge about effectiveness and mediating factors in the treatment of ODDs in children in the context of family functioning, and to propose an innovative approach to the adaptation and implementation of new treatment interventions within clinic settings. The proposed CIT adaptation and implementation model has the potential to enhance implementation and sustainability, and ultimately increase the extent to which effective interventions are available and can impact children and families in need of services for serious behavior problems. ClinicalTrials.gov, ID: NCT02715414 . Registered on 3 March 2016.

Survey of clinical infant lung function testing practices.

PubMed

Peterson-Carmichael, Stacey L; Rosenfeld, Margaret; Ascher, Simon B; Hornik, Christoph P; Arets, H G M; Davis, Stephanie D; Hall, Graham L

2014-02-01

Data supporting the clinical use of infant lung function (ILF) tests are limited making the interpretation of clinical ILF measures difficult. To evaluate current ILF testing practices and to survey users regarding the indications, limitations and perceived clinical benefits of ILF testing. We created a 26-item survey hosted on the European Respiratory Society (ERS) website between January and May 2010. Notifications were sent to members of the ERS, American Thoracic Society and the Asian Pacific Society of Respirology. Responses were sought from ILF laboratory directors and pediatric respirologists. The survey assessed the clinical indications, patient populations, equipment and reference data used, and perceived limitations of ILF testing. We received 148 responses with 98 respondents having ILF equipment and performing testing in a clinical capacity. Centers in North America were less likely to perform ≥50 studies/year than centers in Europe or other continents (13% vs. 41%). Most respondents used ILF data to either "start a new therapy" (78%) or "help decide about initiation of further diagnostic workup such as bronchoscopy, chest CT or serological testing" (69%). Factors reported as limiting clinical ILF testing were need for sedation, uncertainty regarding clinical impact of study results and time intensive nature of the study. Clinical practices associated with ILF testing vary significantly; centers that perform more studies are more likely to use the results for clinical purposes and decision making. The future of ILF testing is uncertain in the face of the limitations perceived by the survey respondents. © 2013 Wiley Periodicals, Inc.

An assessment of the utilization of the preclinical rodent model literature in clinical trials of putative therapeutics for the treatment of alcohol use disorders.

PubMed

Barajaz, Ashley M; Kliethermes, Christopher L

2017-12-01

Rodent models of Alcohol Use Disorders (AUD) are used extensively by preclinical researchers to develop new therapeutics for the treatment of AUD. Although these models play an important role in the development of novel, targeted therapeutics, their role in bringing therapeutics to clinical trials is unclear, as off-label use of existing medications not approved for the treatment of AUD is commonly seen in the clinic and clinical trials. In the current study, we used the Clinicaltrials.gov database to obtain a list of drugs that have been tested for efficacy in a clinical trial between 1997 and 2017. We then conducted a set of literature searches to determine which of the 98 unique drugs we identified had shown efficacy in a rodent model of an AUD prior to being tested in a clinical trial. We found that slightly less than half of the drugs tested in clinical trials (48%) had shown prior efficacy in any rodent model of an AUD, while the remaining 52% of drugs were used off-label, or in some cases, following non-published studies. This study raises the question of how clinical researchers incorporate results from preclinical studies in the decision to bring a drug to a clinical trial. Our results underscore the need for ongoing communication among preclinical and clinical researchers. Copyright © 2017 Elsevier B.V. All rights reserved.

Leveraging Digital Health Technologies and Outpatient Sampling in Clinical Drug Development: A Phase 1 Exploratory Study.

PubMed

Dockendorf, Marissa F; Murthy, Gowri; Bateman, Kevin P; Kothare, Prajakti A; Anderson, Melanie; Xie, Iris; Sachs, Jeff R; Burlage, Rubi; Goldman, Andra; Moyer, Matthew; Shah, Jyoti; Ruba, Rachel; Shipley, Lisa; Harrelson, Jane

2018-06-09

Merck & Co., Inc. (Kenilworth, New Jersey) is investing in approaches to enrich clinical trial data and augment decision-making through utilization of digital health technologies, outpatient sampling, and real-time data access. As part of this strategy, a Phase 1 study was conducted to explore a few technologies of interest. In this fixed-sequence, two-period trial, 16 healthy subjects were administered 50-mg once-daily sitagliptin packaged in a bottle that electronically captured the date and time study medication was dispensed (Period 1) and in a traditional pharmacy bottle (Period 2). Dried blood spot (DBS) samples were collected for sitagliptin concentration analysis on select study days, both in-clinic and at-home, with collection time recorded using an electronic diary in Period 1 and by clinic staff in Period 2. Study results demonstrated the feasibility and subject acceptance of collecting digital adherence data and outpatient DBS samples in clinical trials and highlighted areas for future improvements. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Pros and cons of CLA consumption: an insight from clinical evidences.

PubMed

Benjamin, Sailas; Prakasan, Priji; Sreedharan, Sajith; Wright, Andre-Denis G; Spener, Friedrich

2015-01-01

This comprehensive review critically evaluates whether supposed health benefits propounded upon human consumption of conjugated linoleic acids (CLAs) are clinically proven or not. With a general introduction on the chemistry of CLA, major clinical evidences pertaining to intervention strategies, body composition, cardio-vascular health, immunity, asthma, cancer and diabetes are evaluated. Supposed adverse effects such as oxidative stress, insulin resistance, irritation of intestinal tract and milk fat depression are also examined. It seems that no consistent result was observed even in similar studies conducted at different laboratories, this may be due to variations in age, gender, racial and geographical disparities, coupled with type and dose of CLA supplemented. Thus, supposed promising results reported in mechanistic and pre-clinical studies cannot be extrapolated with humans, mainly due to the lack of inconsistency in analyses, prolonged intervention studies, follow-up studies and international co-ordination of concerted studies. Briefly, clinical evidences accumulated thus far show that CLA is not eliciting significantly promising and consistent health effects so as to uphold it as neither a functional nor a medical food.

Effectiveness of teaching quality improvement to clinicians: a systematic review.

PubMed

Boonyasai, Romsai T; Windish, Donna M; Chakraborti, Chayan; Feldman, Leonard S; Rubin, Haya R; Bass, Eric B

2007-09-05

Accreditation requirements mandate teaching quality improvement (QI) concepts to medical trainees, yet little is known about the effectiveness of teaching QI. To perform a systematic review of the effectiveness of published QI curricula for clinicians and to determine whether teaching methods influence the effectiveness of such curricula. The electronic literature databases of MEDLINE, EMBASE, CINAHL, and ERIC were searched for English-language articles published between January 1, 1980, and April 30, 2007. Experts in the field of QI were queried about relevant studies. Two independent reviewers selected studies for inclusion if the curriculum taught QI principles to clinicians and the evaluation used a comparative study design. Information about the features of each curriculum, its use of 9 principles of adult learning, and the type of educational and clinical outcomes were extracted. The relationship between the outcomes and the number of educational principles used was assessed. Of 39 studies that met eligibility criteria, 31 described team-based projects; 37 combined didactic instruction with experiential learning. The median number of adult learning principles used was 7 (range, 2-8). Evaluations included 22 controlled trials (8 randomized and 14 nonrandomized) and 17 pre/post or time series studies. Fourteen studies described educational outcomes (attitudes, knowledge, or skills or behaviors) and 28 studies described clinical process or patient outcomes. Nine of the 10 studies that evaluated knowledge reported only positive effects but only 2 of these described a validated assessment tool. The 6 assessments of attitudes found mixed results. Four of the 6 studies on skill or behavior outcomes reported only positive effects. Eight of the 28 studies of clinical outcomes reported only beneficial effects. Controlled studies were more likely than other studies to report mixed or null effects. Only 4 studies evaluated both educational and clinical outcomes, providing limited evidence that educational outcomes influence the clinical effectiveness of the interventions. Most published QI curricula apply sound adult learning principles and demonstrate improvement in learners' knowledge or confidence to perform QI. Additional studies are needed to determine whether educational methods have meaningful clinical benefits.

Combinations of Radiotherapy and Immunotherapy for Melanoma: A Review of Clinical Outcomes

PubMed Central

Barker, Christopher A.; Postow, Michael A.

2015-01-01

Radiotherapy has long played a role in the management of melanoma. Recent advances have also demonstrated the efficacy of immunotherapy in the treatment of melanoma. Preclinical data suggest a biologic interaction between radiotherapy and immunotherapy. Several clinical studies corroborate these findings. This review will summarize the outcomes of studies reporting on patients with melanoma treated with a combination of radiotherapy and immunotherapy. Vaccine therapies often use irradiated melanoma cells, and may be enhanced by radiotherapy. The cytokines interferon-alpha and interleukin-2 have been combined with radiotherapy in several small studies, with some evidence suggesting increased toxicity and/or efficacy. Ipilimumab, a monoclonal antibody which blocks cytotoxic T-lymphocyte antigen-4, has been combined with radiotherapy in several notable case studies and series. Finally, pilot studies of adoptive cell transfer have suggested radiotherapy may improve the efficacy of treatment. The review will demonstrate that the combination of radiotherapy and immunotherapy has been reported in several notable case studies, series and clinical trials. These clinical results suggest interaction and the need for further study. PMID:24661650

Pharmacologic therapy for acute pancreatitis

PubMed Central

Kambhampati, Swetha; Park, Walter; Habtezion, Aida

2014-01-01

While conservative management such as fluid, bowel rest, and antibiotics is the mainstay of current acute pancreatitis management, there is a lot of promise in pharmacologic therapies that target various aspects of the pathogenesis of pancreatitis. Extensive review of preclinical studies, which include assessment of therapies such as anti-secretory agents, protease inhibitors, anti-inflammatory agents, and anti-oxidants are discussed. Many of these studies have shown therapeutic benefit and improved survival in experimental models. Based on available preclinical studies, we discuss potential novel targeted pharmacologic approaches that may offer promise in the treatment of acute pancreatitis. To date a variety of clinical studies have assessed the translational potential of animal model effective experimental therapies and have shown either failure or mixed results in human studies. Despite these discouraging clinical studies, there is a great clinical need and there exist several preclinical effective therapies that await investigation in patients. Better understanding of acute pancreatitis pathophysiology and lessons learned from past clinical studies are likely to offer a great foundation upon which to expand future therapies in acute pancreatitis. PMID:25493000

Platelet-rich plasma use in anterior cruciate ligament surgery: systematic review of the literature.

PubMed

Figueroa, David; Figueroa, Francisco; Calvo, Rafael; Vaisman, Alex; Ahumada, Ximena; Arellano, Sergio

2015-05-01

To systematically review the current literature for evidence that would substantiate the use of platelet-rich plasma (PRP) in the treatment of anterior cruciate ligament (ACL) ruptures. We performed a systematic search in PubMed and Embase of studies written in the English and Spanish languages that compared the use of PRP with a control group in patients with ACL injuries assessing graft-to-bone healing, graft maturation, and/or clinical outcomes and were randomized controlled trials or prospective cohort studies. Eleven studies fulfilled the inclusion criteria, comprising 516 patients (266 ACL reconstructions using PRP and 250 ACL reconstructions without PRP). Six studies reported a statistically significant difference (4 studies) or tendency toward faster graft maturation in the platelet group (2 studies). One study found no differences. Regarding tunnel healing/widening, 1 study showed faster healing in the PRP group and 5 studies showed no differences between the 2 groups. Considering clinical outcomes, 1 study showed better clinical outcomes with PRP use and 5 studies showed no benefits with the use of PRP. Concerning ACL graft maturation, there is promising evidence that the addition of PRP could be a synergic factor in acquiring maturity more quickly than grafts with no PRP, with the clinical implication of this remaining unclear. Regarding tunnel healing, it appears that there is not an improvement with the addition of PRP. There is no proof that clinical outcomes of ACL surgery are enhanced by the use of PRP. Level III, systematic review of Level I through III studies. Copyright © 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.