scholarly journals Understanding implementability in clinical trials: a pragmatic review and concept map

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Miranda S. Cumpston ◽  
◽  
Steven A. Webb ◽  
Philippa Middleton ◽  
Greg Sharplin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Reference Group ◽  
Concept Map ◽  
Late Phase ◽  
Pragmatic Trials ◽  
Practical Action ◽  
Health Related ◽  
Phase Clinical Trial ◽  
Guidance Documents ◽  
Future Work

Abstract Background The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the ‘implementability’ of trials as they are designed and conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability. Methods Documents were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019. Results Sixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map. Conclusions The concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia. Trial registration This review did not include health-related outcomes and was therefore not eligible for registration in the PROSPERO register.

Assessing intra-individual changes in health related quality of life data in psychiatric clinical trials

2004 ◽  
Vol 15 (5) ◽  
pp. 491-499
Author(s):  
Sati Mazumdar ◽  
Mary Amanda Dew ◽  
Patricia R. Houck ◽  
Charles F. Reynolds
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Health Related Quality ◽  
Life Data ◽  
Related Quality ◽  
Health Related

Compliance with dietary guidelines and its relationship with symptoms and clinical outcomes in patients with advanced cancer in early-phase oncology clinical trials.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 199-199
Author(s):  
Goldy George ◽  
Alan J Kim ◽  
Melat Gebremeskel ◽  
Meryna Manandhar ◽  
Harsha M Pradeep ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Advanced Cancer ◽  
Early Phase ◽  
Symptom Burden ◽  
Whole Grains ◽  
Dietary Guidelines ◽  
Early Phase Clinical Trial ◽  
Dietary Guidelines For Americans ◽  
Phase Clinical Trial

199 Background: We examined compliance with the Dietary Guidelines for Americans and its association with symptom burden and clinical outcomes in patients with advanced cancer in early-phase clinical trials testing novel immunotherapeutic and targeted agents. Methods: Patients starting an early-phase clinical trial (ECOG-PS = 0-1) were recruited into a prospective, longitudinal design with assessments at baseline and at the end of Cycle 1. Diet and symptom burden were assessed using the validated National Cancer Institute Diet History Questionnaire (NCI-DHQ) and the MD Anderson Symptom Inventory, respectively. Compliance with the Dietary Guidelines for Americans recommendations was measured via the Healthy Eating Index (HEI) (a measure of dietary intake per total energy), computed from NCI-DHQ food group and nutrient scores; higher HEI scores indicate greater compliance with dietary guidance recommendations (possible range = 0–100). Statistical tests included Spearman rank correlations (rho), and Cox proportional hazards models. Results: Among early-phase clinical trial patients [N = 40; 50% female; 80% Non-Hispanic White; 80% ECOG = 1; 36% on trials including an immunotherapeutic agent and 64% on targeted therapy trials; mean age = 55y; mean BMI = 28], mean HEI was 69, compared to 59 for the US general population. The proportion of phase I clinical trial patients who met adequacy guidelines were 80% for whole fruit, 73% for total protein foods, 55% for seafood and plant proteins, 55% for total fruit, 50% for greens and beans, 28% for total vegetables, 15% for fatty acids [(PUFAs + MUFAs)/SFAs ≥2.5], 13% for dairy, and 0% for whole grains. The proportion of patients who met moderation guidelines were 28% for refined grains, 28% for added sugar, 13% for saturated fat, and 0% for sodium. Female patients had higher HEI scores than male patients (73 vs. 65, P = 0.004). Patients who were normal weight (BMI < 25) had higher scores for meeting the moderation in sugar intake guideline than overweight patients (BMI≥25) (7.7 vs. 5.5, P = 0.031). Higher intakes of cooked lean meat from beef, pork, veal, lamb, and game were linked to prolonged overall survival (HR = 0.5, 95%CI = 0.26, 0.96, P = 0.039). In immunotherapy patients, greater compliance with seafood and plant protein recommendations was associated with less fatigue at end of Cycle 1 (rho = -0.7, P = 0.008); in targeted therapy patients, higher glycemic load was associated with worse pain (rho = 0.7, P = 0.004). Conclusions: Diets of these early-phase clinical trial patients overall were congruent with recommendations in the Dietary Guidelines for Americans. However, increasing intakes of whole grains and reducing sodium intakes may be useful dietary goals for this population. Also, dietary factors may influence symptoms, such as fatigue and pain, in early-phase clinical trial patients with advanced cancer.

Cancer beliefs in cancer survivors, cancer relatives and persons with no cancer experience

2017 ◽  
Vol 47 (5) ◽  
pp. 497-503 ◽  
Author(s):  
Anette Fischer Pedersen ◽  
Peter Vedsted
Keyword(s):  
Socioeconomic Position ◽  
Reference Group ◽  
Population Based ◽  
Death Sentence ◽  
Cross Sectional ◽  
Telephone Interviews ◽  
Health Related ◽  
Cancer Experience ◽  
Cancer Beliefs ◽  
The Impact

Aims: Negative cancer beliefs have been associated with late stage at cancer diagnosis. High levels of negative cancer beliefs have been found among individuals with low socioeconomic position and ethnic minority women, but the impact of cancer experience on cancer beliefs is unexamined. The aim of this study was to examine whether cancer beliefs are associated with cancer experience. Methods: This was a cross-sectional population-based study. Telephone interviews of 2992 Danish residents (30+) were carried out using the Awareness and Beliefs about Cancer Measure (ABC). Respondents reported whether they or someone close had been diagnosed with cancer and whether they agreed/disagreed with three positively and three negatively framed cancer beliefs. Results: Respondents with someone close diagnosed was reference group. Compared with these, respondents with no cancer experience (RRadj=0.91, 95% CI=0.84–0.98) or who had had cancer themselves (RRadj=0.87, 0.77–0.98) were less likely to believe that cancer treatment is worse than the cancer itself, and respondents with no cancer experience were less likely to believe that a diagnosis of cancer is a death sentence (RRadj=0.83, 0.70–0.98), but more likely to report that they did not want to know if they had cancer (RRadj=1.31, 1.01–1.71). Conclusions: The results suggest that cancer beliefs are sensitive to cancer experience. This is an important addition to previous results focusing on the association between cancer beliefs and static factors such as socioeconomic position and ethnicity. Since cancer beliefs may determine health-related behaviour, it is important that negative cancer beliefs are addressed and possibly reframed in population-based interventions.

scholarly journals Expectations and desires of palliative health care personnel concerning their future work culture

2013 ◽  
Vol 2 (3) ◽  
pp. 46 ◽  
Author(s):  
Beate Andre ◽  
Endre Sjøvold ◽  
Marte Holmemo ◽  
Toril Rannestad ◽  
Gerd I. Ringdal
Keyword(s):  
Health Care ◽  
Reference Group ◽  
Health Care Personnel ◽  
Future Perspective ◽  
Work Culture ◽  
Care Workers ◽  
Positive Work Culture ◽  
And Control ◽  
Future Work ◽  
Positive Work

Introduction: Exploring the work culture of health care personnel is important in order to understand the challenges they face and the issues they experience. Believing in and shaping their futures indicates a working culture influenced by promoting factors. The aims of this study were to explore how health care workers at a Palliative Medicine Unit perceive their future work culture would be and whether they perceive that their expectations and desires will be fulfilled. Design: A correlational study. Methods: Health care personnel, physicians, nurses, physiotherapists, and others (N = 26) at a PMU in Norway completed a questionnaire according to the two perspectives, expectations (future) and desire (wish). The findings in these two perspectives were compared. The method seeks to explore what aspects dominate the particular work culture and identifying challenges, limitations, and opportunities. The findings were also compared with a reference group of 347 ratings of well-functioning Norwegian organizations, named the “Norwegian Norm”. Results: The findings for the wish perspective showed significant (p<0.05; p<0.01) higher rates for nurturing and synergy dimensions and significant lower rates (p>0.05; p>0.05) for opposition and control dimensions than the findings for the future perspective. Conclusions: It appears that the health care personnel wish for changes that they don’t believe they will achieve. The changes the respondents wish for are fewer negative work culture qualities, such as assertiveness and resignation, and more positive work culture qualities, such as engagement and empathy. Changes must be made to give the health care personnel improved working conditions and empowerment in order to change their situations to reflect what they wish for. The present findings can give an indication as to the direction that research ought to follow in subsequent studies.

scholarly journals Trends and Gaps in Ontology-Supported Environmental Health

2021 ◽  
Author(s):  
Lucas Felipe Moreira Silva ◽  
Renato Bulcão-Neto
Keyword(s):  
Public Health ◽  
Environmental Health ◽  
Biological Factors ◽  
Exclusion Criteria ◽  
Selection Strategies ◽  
Research Theme ◽  
Data Life Cycle ◽  
Health Related ◽  
Literature Mapping ◽  
Future Work

Environmental Health (EH) refers to aspects of human health affectedby factors in the environment, e.g., biological factors, andit is an essential part of any comprehensive public health system.Similar to other health-related fields, one observes an increasingmovement in the adoption of IoT technologies into the EH domain.Regarding the data life cycle in IoT systems, data modeling andinterpretation are crucial tasks in which ontologies are a feasiblesolution because of their expressiveness and reasoning support.In this paper, we structure the ontology-supported EH researchtheme through a systematic literature mapping. The identificationand selection strategies of primary studies include the automaticsearch for studies published from 2010 to 2019 on five sourcesand the application of inclusion and exclusion criteria on an eighthundred-eleven-distinct-paper group. The results of this originalwork provide an overview of the research theme with multipleclassifications of thirty-four relevant studies remaining as well asthe finding of trends and gaps for future work.

scholarly journals A pragmatic view on pragmatic trials

2011 ◽  
Vol 13 (2) ◽  
pp. 217-224 ◽  
Keyword(s):  
Clinical Trials ◽  
Medical Practice ◽  
Real Life ◽  
Main Tool ◽  
Health Sciences ◽  
Routine Practice ◽  
Special Focus ◽  
Pragmatic Trials ◽  
Explanatory Trials

Clinical trials have been the main tool used by the health sciences community to test and evaluate interventions, Trials can fall into two broad categories: pragmatic and explanatory. Pragmatic trials are designed to evaluate the effectiveness of interventions in real-life routine practice conditions, whereas explanatory trials aim to test whether an intervention works under optimal situations. Pragmatic trials produce results that can be generalized and applied in routine practice settings. Since most results from exploratory trials fail to be broadly generalizable, the "pragmatic design" has gained momentum. This review describes the concept of pragmatism, and explains in particular that there is a continuum between pragmatic and explanatory trials, rather than a dichotomy. Special focus is put on the limitations of the pragmatic trials, while recognizing the importance for and impact of this design on medical practice.

scholarly journals Clinical Trial Regulations In India : Past, Present and Future

JMS SKIMS ◽  
2017 ◽  
Vol 20 (1) ◽  
pp. 5-17
Author(s):  
Haroon Rashid
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Disease Burden ◽  
International Standards ◽  
New Drugs ◽  
Safety And Efficacy ◽  
Long Time ◽  
Regulatory Bodies ◽  
Guidance Documents ◽  
Human Use

Clinical trials are the only way of establishing the safety and efficacy of any new drug before its introduction in the market for human use. Clinical trials (with safeguards) are necessary for introduction of new drugs for a country like India, considering its disease burden and emergence of new variants of disease.The regulatory bodies need to frame guidelines and regulatory approval processes on a par with international standards. Many of the new laws, guidance documents, notifications and initiatives for regulating pharmaceutical industry were in the charts for quite a long time. Indian regulatory authorities have started looking into speedy implementation and providing support in terms ofnecessary infrastructure and investment. JMS 2017; 20(1):5-17

scholarly journals Critical Appraisal on the Selection Criteria for Evidence-based Healthcare

2021 ◽  
Author(s):  
Paulo Cesar Morales Mayer ◽  
Caroline Amélia Gonçalves ◽  
Franz Porzsolt
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Selection Criteria ◽  
Human Subjects ◽  
Evidence Based ◽  
Inclusion Criteria ◽  
Pragmatic Trials ◽  
Exclusion Criteria ◽  
Policy Makers ◽  
Evidence Based Healthcare

Abstract Background: Evidence-Based healthcare deals basically with published clinical trials to guide the decision making on what treatment to use for any specific conditions.Aims: The present paper assessed the inclusion and exclusion criteria used in clinical trials of cervical cancer aiming at establishing a clear distinction between each criterion.Methods: We performed a bibliographical search in pubmed with the terms cervical cancer and treatment or therapy filtered for clinical trials with human subjects for the last ten years. A total of 30 papers were used extracting and classifying the inclusion and exclusion category according to the characteristic they described. Results: We found no clear parameter to establish which criteria could exclusively serve as inclusion or exclusion across the papers, about 56% of the categories identified were found either listed as inclusion or exclusion criteria or even as both in some cases.Conclusions: The key issue of selection criteria is not in its form but in its function, the first point to consider is if the trial is experimental (focused on efficacy and proof of principle) or observational (pragmatic trials, focused on effectiveness and real world conditions). We suggest, inclusion criteria should be broad, focused on the investigated condition; exclusion criteria should apply only to the subset of this “included” population, and do not take part in observational studies. These conclusions do not serve only for researchers but should affect practitioners and policy makers to correctly compare the results of investigated treatment.

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