Can Investigator Certification Improve the Quality of Clinical Research?

Abstract Background Primary sclerosing cholangitis (PSC) is a rare bile duct and liver disease which can considerably impact quality of life (QoL). As part of a project developing a measure of QoL for people with PSC, we conducted a systematic review with four review questions. The first of these questions overlaps with a recently published systematic review, so this paper reports on the last three of our initial four questions: (A) How does QoL in PSC compare with other groups?, (B) Which attributes/factors are associated with impaired QoL in PSC?, (C) Which interventions are effective in improving QoL in people with PSC?. Methods We systematically searched five databases from inception to 1 November 2020 and assessed the methodological quality of included studies using standard checklists. Results We identified 28 studies: 17 for (A), ten for (B), and nine for (C). Limited evidence was found for all review questions, with few studies included in each comparison, and small sample sizes. The limited evidence available indicated poorer QoL for people with PSC compared with healthy controls, but findings were mixed for comparisons with the general population. QoL outcomes in PSC were comparable to other chronic conditions. Itch, pain, jaundice, severity of inflammatory bowel disease, liver cirrhosis, and large-duct PSC were all associated with impaired QoL. No associations were found between QoL and PSC severity measured with surrogate markers of disease progression or one of three prognostic scoring systems. No interventions were found to improve QoL outcomes. Conclusion The limited findings from included studies suggest that markers of disease progression used in clinical trials may not reflect the experiences of people with PSC. This highlights the importance for clinical research studies to assess QoL alongside clinical and laboratory-based outcomes. A valid and responsive PSC-specific measure of QoL, to adequately capture all issues of importance to people with PSC, would therefore be helpful for clinical research studies.

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Preparation of irreversible hydrocolloids to improve retention of complete dentures

Medicinski pregled ◽

10.2298/mpns0804131a ◽

2008 ◽

Vol 61 (3-4) ◽

pp. 131-134

Author(s):

Ljiljana Aleksov ◽

Sasa Stankovic ◽

Zorica Ajdukovic

Keyword(s):

Clinical Research ◽

Dimensional Change ◽

Complete Dentures ◽

Consistency Analysis ◽

Working Models ◽

Retention Force ◽

Impression Materials ◽

Research Show

Introduction Precise reproduction of anatomical-morphological details of dentures support on working models presupposes adequate application of modern impression materials and casting procedure, as well as minimal dimensional change of these materials. The aim of the study: experimental and clinical research is connected to irreversible hydrocolloids and the objective was to examine the most suitable consistency of the alginate as the impression mass for the purpose of improving retention of complete dentures. Material and methods This research included 35 completely toothless patients, most of who had already had complete dentures, 40-80 years of age and of both sexes. Static adhesion was measured with aery late plates made of adequate corresponding and various models depending on consistency of the irreversible hydrocolloids. Each model was cut into three parts, the cuts obtained were mutually compared, and computerized graphic charts of each section were made. Results The results of the research show that there is a greater retention force in the acrylate plates obtained on models castled on an anatomical impression base taken with irreversible hydrocolloides of solid consistency. Analysis of the results shows such quality of impressed tissues that they are practically slightly displaced by the impressions regardless of the consistency of the material impressed. Conclusion In conclusion it is pointed out that the preparation of irreversible hydrocolloides must be carried out by strictly obeying the powder-water weight ratios. The sections of the models obtained by irreversible hydrocolloides of various consistencies, that is by applying different pressures, point to minimal displacement of tissues and great differences in the retention force in favor of the compressive impression.

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Poor quality of clinical research in radiology: another indictment.

Radiology ◽

10.1148/radiology.170.2.2911652 ◽

1989 ◽

Vol 170 (2) ◽

pp. 311-312 ◽

Cited By ~ 2

Author(s):

G L Wolf

Keyword(s):

Clinical Research ◽

Poor Quality

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Participation in Clinical Trials May Improve Care of Acute Schizophrenia Inpatients in a General Hospital

CNS Spectrums ◽

10.1017/s1092852900013870 ◽

2008 ◽

Vol 13 (9) ◽

pp. 757-761 ◽

Cited By ~ 2

Author(s):

Uriel Halbreich ◽

Nancy Smail ◽

Xin Tu ◽

Judith Halbreich

Keyword(s):

Quality Of Care ◽

Clinical Research ◽

Psychiatric Patients ◽

Diagnostic Interview ◽

Physical Restraints ◽

Double Blind ◽

Acute Schizophrenia ◽

Hospital Wards ◽

Study Inclusion

AbstractIntroduction: This report demonstrates parameters of quality of care and treatment outcome of acute schizophrenia patients who were involved as subjects in a clinical trial of two marketed widely used antipsychotics compared with their fellow patients who received routine clinical hospital care.Methods: Patients were newly admitted severely agitated schizophrenia patients who agreed to participate in a double-blind randomized trial of short-term (5 days) rate of improvement in response to two second-generation oral antipsychotics. Treatment outcomes as measured by the Clinical Global Impression and parameters of quality of care were compared with the general population of inpatients in the same county hospital.Results: Of 145 patients screened, 109 patients did not meet study inclusion and exclusion criteria. It is of note that systematic diagnostic interview did not confirm the clinical diagnosis of schizophrenia in 17 patients (11.7%). Study patients had shorter length of stay (6.75 days vs 15.3 days of total psychiatric patients at the hospital during the study period), no physical restraints (vs 21.9%), no use of antipsychotics as chemical restraints (vs 19.8%), and less recidivism following the trial (28.1%) compared with prior to the trial (64.3%).Conclusion: Patients who participate in structured clinical research with well-delineated procedures, clinical outcome measures, and clear expectations, faired better than their fellow patients in the same non-research hospital wards. Application of some characteristics of clinical research to the diagnosis and treatment of clinical non-research patients may be considered.

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The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

10.21203/rs.3.rs-84171/v1 ◽

2020 ◽

Author(s):

Liran Chen ◽

Zhimin Chen ◽

Huafang Chen

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Research ◽

Structural Changes ◽

Continuous Increase ◽

Clinical Trial Research ◽

Clinical Research Coordinator ◽

Research Coordinator ◽

Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

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Quality of Life as an Important Clinical Research Treatment Trial Outcome to Guide Evidence‐Based Practice

Worldviews on Evidence-Based Nursing ◽

10.1111/wvn.12441 ◽

2020 ◽

Vol 17 (5) ◽

pp. 334-336

Author(s):

Dorothy Dulko

Keyword(s):

Quality Of Life ◽

Clinical Research ◽

Evidence Based Practice ◽

Evidence Based ◽

Treatment Trial ◽

Trial Outcome

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Assessing Health-Related Quality of Life in Children and Adolescents with Diabetes: Development and Psychometrics of the Type 1 Diabetes and Life (T1DAL) Measures

Journal of Pediatric Psychology ◽

10.1093/jpepsy/jsz083 ◽

2019 ◽

Cited By ~ 1

Author(s):

Marisa E Hilliard ◽

Charles G Minard ◽

David G Marrero ◽

Maartje de Wit ◽

Debbe Thompson ◽

...

Keyword(s):

Quality Of Life ◽

Type 1 Diabetes ◽

Clinical Research ◽

Children And Adolescents ◽

Cognitive Debriefing ◽

Health Related Quality ◽

Related Quality ◽

Health Related

Abstract Objective To develop and validate new measures of diabetes-specific health-related quality of life (HRQOL) for people with type 1 diabetes (T1D) that are brief, developmentally appropriate, and usable in clinical research and care. Here we report on the phases of developing and validating the self-report Type 1 Diabetes and Life (T1DAL) measures for children (age 8–11) and adolescents (age 12–17). Methods Measure development included qualitative interviews with youth and parents (n = 16 dyads) followed by piloting draft measures and conducting cognitive debriefing with youth (n = 9) to refine the measures. To evaluate the psychometric properties, children (n = 194) and adolescents (n = 257) at three T1D Exchange Clinic Network sites completed the age-appropriate T1DAL measure and previously validated questionnaires measuring related constructs. Using psychometric data, the investigators reduced the length of each T1DAL measure to 21 and 23 items, respectively, and conducted a final round of cognitive debriefing with six children and adolescents. Results The T1DAL measures for children and adolescents demonstrated good internal consistency (α = 0.84 and 0.89, respectively) and test–retest reliability (r = 0.78 and 0.80, respectively). Significant correlations between the T1DAL scores and measures of general quality of life, generic and diabetes-specific HRQOL, diabetes burden, and diabetes strengths demonstrated construct validity. Correlations with measures of self-management (child and adolescent) and glycemic control (adolescent only) demonstrated criterion validity. Factor analyses indicated four developmentally specific subscales per measure. Participants reported satisfaction with the measures. Conclusions The new T1DAL measures for children and adolescents with T1D are reliable, valid, and suitable for use in care settings and clinical research.

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W18: HEALTH STATUS AND QUALITY OF LIFE MEASURES IN INTERNATIONAL CLINICAL RESEARCH

Value in Health ◽

10.1016/s1098-3015(11)70158-9 ◽

1999 ◽

Vol 2 (1) ◽

pp. 48

Author(s):

P Marquis ◽

L Abetz ◽

K Conway ◽

I Mear

Keyword(s):

Quality Of Life ◽

Health Status ◽

Clinical Research ◽

Quality Of Life Measures ◽

International Clinical Research

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Contract Clinical Research: A Rapidly Changing Marketplace

Journal of Pharmacy Practice ◽

10.1177/089719009600900604 ◽

1996 ◽

Vol 9 (6) ◽

pp. 406-415

Author(s):

Daniel Krichbaum ◽

Alan Rosenthal

Keyword(s):

Clinical Research ◽

The United States ◽

Considerable Change ◽

Business Strategies ◽

Quality Data ◽

Scientific Integrity ◽

Research Activities ◽

Large Numbers ◽

Research Organizations

Drug development in the United States has undergone considerable change over the past decade. The outsourcing of clinical research activities to Contract Research Organizations (CROs) continues to escalate in an attempt to speed drugs to market faster. The increasing use of business strategies at the investigational site level has fostered the emergence of specialty networks and Site Management Organizations (SMOs). SMOs offer pharmaceutical and biotechnology sponsors the ability to work with a tightly managed network of experienced professional multispecialty research centers that can enroll large numbers of patients and provide high quality data. While these organizations have fundamentally changed the way drugs are developed, they have also contributed to an acceleration of the process and an improvement in the scientific integrity and quality of the data.

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