scholarly journals Patient perceptions of the challenges of recruitment to a renal randomised trial registry: a pilot questionnaire-based study

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ellen Murphy ◽  
Aoife O’Keeffe ◽  
Niamh O Shea ◽  
Eva Long ◽  
Joseph A. Eustace ◽  
...  
Keyword(s):  
External Validity ◽  
Quantitative Data ◽  
Observational Studies ◽  
Randomised Trial ◽  
Renal Dialysis ◽  
Current Treatment ◽  
Descriptive Statistics ◽  
Trial Registry ◽  
Cross Sectional ◽  
Randomised Controlled

Abstract Background Randomised controlled trials (RCTs) are the gold standard for demonstrating the efficacy of new therapies. However, issues of external validity often affect result application to real-world settings. Using registries to conduct RCTs is a reasonably new practice, but is appealing because it combines the benefits of both observational studies and RCTs. There is limited literature on patient motivators, barriers, and consent to registries for conducting RCTs. The purpose of our study was to establish the factors that motivate and/or inhibit patients from joining a registry for RCTs and to determine what information matters to patients when making an enrolment decision to participate in such a registry. Methods We conducted a cross-sectional questionnaire-based study at a dialysis centre in Southwest Ireland representing a catchment patient population of approximately 430,000. Quantitative data were coded and analysed in SPSS (v16). Descriptive statistics were produced, and open-ended questions were analysed by thematic analysis. Results Eighty-seven patients completed the questionnaire. Reasons for participation in a registry included personal and altruistic benefits. Barriers to participation were time and travel requirements associated with registry participation, data safety concerns, risks, side effects, and concerns that registry participation would impact current treatment. Although 29.8% of patients expressed concern regarding their data being stored in a registry, 79.3% were still willing to consent to have their data uploaded and stored in a registry for conducting RCTs. It was important to patients to have their GP (general practitioner) involved in the decision to participate, despite little day-to-day contact with their GP for renal dialysis management. Conclusion Challenges to recruitment to registries for RCTs exist, but addressing the identified concerns of potential participants may aid patients in making a more informed enrolment decision and may improve recruitment to registries, and by extension, to RCTs conducted using the registry.

scholarly journals Patient Perceptions of the Challenges to Recruitment Into a Renal Rct Registry : A Pilot Questionnaire Based Study

2021 ◽  
Author(s):  
Ellen Murphy ◽  
Niamh O Shea ◽  
Eva Long ◽  
Joseph A Eustace ◽  
Frances Shiely
Keyword(s):  
Quantitative Data ◽  
Observational Studies ◽  
Controlled Trial ◽  
Renal Dialysis ◽  
Current Treatment ◽  
Descriptive Statistics ◽  
Cross Sectional ◽  
Randomised Controlled ◽  
Stage Renal Disease ◽  
End Stage

Abstract Background Randomised controlled trials (RCTs) are the gold standard for demonstrating the efficacy of new therapies. Despite this, nephrology trials, especially of patients with end-stage renal disease (ESRD) are much fewer in number than other medical subspecialties. Recruitment difficulties are cited as a particular challenge. Using registries to conduct RCTs is a reasonably new practice but is appealing as it combines the benefits of both observational studies and clinical trials. There is limited literature on patient motivators, barriers, and consent to these registries. The purpose of our study was to establish the factors that motivate and/or inhibit patients from joining a registry for randomised controlled trial, and to determine what information matters to patients when making an enrolment decision to participate in such a registry. MethodsWe conducted a cross-sectional questionnaire-based study at a dialysis centre in Southwest Ireland representing a catchment patient population of approximately 430,000. Quantitative data were coded and analysed in SPSS (v16). Descriptive statistics were produced, and open-ended questions were analysed by thematic analysis. Results 87 patients completed the questionnaire. Reasons for participation in the registry included personal and altruistic benefits. Barriers were time and travel requirements associated with registry participation, data safety concerns, risks, and side effects, along with concerns that registry participation would impact their current treatment. Although 29.8% of patients expressed, that they would have concerns regarding their data being stored in a registry, 79.3% of patients were still willing to consent to have their data uploaded and stored in a registry for conducting RCTs. It was important to patients to have their GP (general practitioner) involved in the decision to participate, despite little day-to-day contact with their GP for renal dialysis management. ConclusionChallenges to recruitment to registries for RCTs exist but addressing the identified concerns of potential participants may improve recruitment to registries, and by extension, to RCTs conducted using the registry.

scholarly journals The Challenges of Recruitment to a Randomised Trial Registry – What Information Matters to the Patient?

2021 ◽  
Author(s):  
Ellen Murphy ◽  
Niamh O Shea ◽  
Aoife O'Keeffe ◽  
Eva Long ◽  
Joseph Eustace ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Data Storage ◽  
Randomised Trial ◽  
Renal Dialysis ◽  
Current Treatment ◽  
Cross Sectional ◽  
Strongly Agree ◽  
Randomised Controlled ◽  
Stage Renal Disease ◽  
End Stage

Abstract Background Randomised controlled trials (RCTs) are the gold standard for demonstrating efficacy of new therapies. Despite this, nephrology trials, especially of patients with end stage renal disease (ESRD) are much fewer in number than other specialties. Recruitment difficulties are cited as a particular challenge. Using registries to conduct RCTs is a reasonably new practice but is appealing as it combines the benefits of observational studies and clinical trials. There is limited literature on patient motivators, barriers, and consent to these registries. The purpose of our study is to establish this. MethodsWe conducted a cross-sectional questionnaire-based study. A questionnaire consisting of closed and open-ended questions was collected at a dialysis centre in Southwest Ireland representing a catchment patient population of approximately 430,000. Quantitative data were coded and analysed in SPSS (v16). Descriptive statistics were produced, and open-ended questions were analysed by thematic analysis. Results 87 patients completed the questionnaire. Motivators for participation included personal and altruistic benefits. Barriers/concerns include time requirements, risks (incl. data safety) and side effects along with impacts on current treatment. Though a total of 29.8% of patients ‘strongly agree/agree’ to having concerns regarding their data storage in a registry, 79.3% of patients were ‘very likely/likely’ to consent to participate in the registry. It was important to patients to have their GP (general practitioner) involved in the decision to participate, despite little day-to-day contact with their GP for renal dialysis management. ConclusionImproving patients understanding of clinical trials, emphasising personal and altruistic benefits, and addressing patient’s concerns regarding time and risks of involvement, may improve their likelihood to participate in a registry for RCTs and more broadly speaking, RCTs.

scholarly journals Recommendations for Designing, Conducting and Reporting Observational Studies in Homeopathy

Homeopathy ◽  
2020 ◽  
Vol 109 (03) ◽  
pp. 114-125
Author(s):  
Michael Teut ◽  
Harald Walach ◽  
Roja Varanasi ◽  
Raj K. Manchanda ◽  
Praveen Oberai ◽  
...  
Keyword(s):  
External Validity ◽  
Observational Studies ◽  
Internal Validity ◽  
Cross Sectional Study ◽  
Research Field ◽  
Observational Research ◽  
Special Focus ◽  
Cross Sectional ◽  
Randomised Controlled ◽  
Strobe Statement

Abstract Background Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades. Method We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide. Results Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe “real-world” care settings and can assist with the design and inform the results of randomised controlled trails. Conclusions We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.

Patient Preferences in Randomised Trials: Threat or Opportunity?

1996 ◽  
Vol 1 (4) ◽  
pp. 194-197 ◽  
Author(s):  
David J. Torgerson ◽  
Jennifer Klaber-Moffett ◽  
Ian T. Russell
Keyword(s):  
Back Pain ◽  
External Validity ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Final Analysis ◽  
Exercise Programme ◽  
Randomised Trials ◽  
Prognostic Variables ◽  
New Treatment ◽  
Randomised Controlled

Objectives: To assess whether it is feasible to elicit patients’ preferences for treatments and then to proceed with randomisation which may allocate those with preferences to their less preferred treatment; and to describe which prognostic variables were associated with such preferences within the context of a randomised trial of an exercise programme for back pain. Methods: The first 97 patients enrolled in a randomised controlled trial (RCT) for the treatment of back pain were asked about their preferences, health characteristics and other prognostic variables. Results: Fifty-eight (60%) patients preferred to be allocated to the exercise programme whilst 38 (39%) were indifferent; one patient preferred conventional general practitioner (GP) management. No patient refused randomisation. Comparing patients preferring the exercise programme with indifferent patients showed that the former had a higher belief in the effectiveness of the new treatment ( P > 0.01), tended to have worse back pain ( P = 0.09), had back pain for a shorter duration ( P = 0.04), and tended to have had more GP home visits ( P = 0.06). Conclusions: For many randomised trials preference may be an important prognostic variable. In such circumstances, preference should be taken into account in the final analysis. This study demonstrates it is sometimes feasible to randomise patients to their less preferred treatment, thus allowing more robust statistical comparisons between randomised groups. This modification may make RCTs more rigorous and improve their external validity.

scholarly journals Metabolomic profiling of urine: response to a randomised, controlled feeding study of select fruits and vegetables, and application to an observational study

2013 ◽  
Vol 110 (10) ◽  
pp. 1760-1770 ◽  
Author(s):  
Damon H. May ◽  
Sandi L. Navarro ◽  
Ingo Ruczinski ◽  
Jason Hogan ◽  
Yuko Ogata ◽  
...  
Keyword(s):  
Observational Study ◽  
Fruits And Vegetables ◽  
Randomised Trial ◽  
Basal Diet ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Fruit And Vegetable ◽  
Cross Sectional ◽  
Food Records ◽  
Randomised Controlled

Metabolomic profiles were used to characterise the effects of consuming a high-phytochemical diet compared with a diet devoid of fruits and vegetables (F&V) in a randomised trial and cross-sectional study. In the trial, 8 h fasting urine from healthy men (n 5) and women (n 5) was collected after a 2-week randomised, controlled trial of two diet periods: a diet rich in cruciferous vegetables, citrus and soya (F&V), and a fruit- and vegetable-free (basal) diet. Among the ions found to differentiate the diets, 176 were putatively annotated with compound identifications, with forty-six supported by MS/MS fragment evidence. Metabolites more abundant in the F&V diet included markers of the dietary intervention (e.g. crucifers, citrus and soya), fatty acids and niacin metabolites. Ions more abundant in the basal diet included riboflavin, several acylcarnitines and amino acid metabolites. In the cross-sectional study, we compared the participants based on the tertiles of crucifers, citrus and soya from 3 d food records (n 36) and FFQ (n 57); intake was separately divided into the tertiles of total fruit and vegetable intake for FFQ. As a group, ions individually differential between the experimental diets differentiated the observational study participants. However, only four ions were significant individually, differentiating the third v. first tertile of crucifer, citrus and soya intake based on 3 d food records. One of these ions was putatively annotated: proline betaine, a marker of citrus consumption. There were no ions significantly distinguishing tertiles by FFQ. The metabolomic assessment of controlled dietary interventions provides a more accurate and stronger characterisation of the diet than observational data.

scholarly journals Appearance of Nurses and Perceived Professionalism

2018 ◽  
Vol 3 (3) ◽  
pp. 30 ◽  
Author(s):  
Nikki L. Wills ◽  
Brittany Wilson ◽  
Eva B. Woodcock ◽  
Samuel P. Abraham ◽  
Deborah R. Gillum
Keyword(s):  
Experimental Study ◽  
Literature Review ◽  
Quantitative Data ◽  
Research Question ◽  
Descriptive Statistics ◽  
Complex Nature ◽  
Cross Sectional ◽  
Study Results ◽  
Orem's Theory ◽  
The Given

Background: After completing a literature review on the topic of appearance and professionalism a knowledge gap was identified, relating to how individuals perceive professionalism based on appearance. First impressions are how patients form opinions of their nurses. Professionalism is influenced by many variables, such as hair, make-up, uniform, behavior, and image. Purpose: The purpose of this study was to explore perceptions of a nurse’s appearance and projected professionalism. Method: A total of 120 students volunteered to participate in the study. The research question was: “How do college students perceive the professional appearance of the nurse?” This was a quantitative, cross-sectional, non-experimental study with a descriptive design. A qualitative question was also asked to complement the quantitative data. The survey contained 3 demographic questions and 18 items based on the participant’s perception of the perceived professionalism using the given images. The data collected were analyzed using descriptive statistics. Orem’s theory of self-care was used to guide this study. Results: The results confirmed the complex nature of the nursing image. Participants perceived a nurse who took extra time to improve appearance to be professional, trustworthy and least lazy. A not so prepared nurse was perceived to lack confidence and also to be less compassionate.

The association between dietary inflammatory index and risk of central obesity in adults: An updated systematic review and meta-analysis

2020 ◽  
Vol 90 (5-6) ◽  
pp. 535-552 ◽  
Author(s):  
Mahdieh Abbasalizad Farhangi ◽  
Mahdi Vajdi
Keyword(s):  
Systematic Review ◽  
Observational Studies ◽  
Central Obesity ◽  
Assessment Tool ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Dietary Factors ◽  
Cross Sectional ◽  
Inflammatory Status ◽  
Obesity Indices

Abstract. Backgrounds: Central obesity, as a pivotal component of metabolic syndrome is associated with numerous co-morbidities. Dietary factors influence central obesity by increased inflammatory status. However, recent studies didn’t evaluate the association between central obesity and dietary inflammation index (DII®) that give score to dietary factors according to their inflammatory potential. In the current systematic review and meta-analysis, we summarized the studies that investigated the association between DII® with central obesity indices in the general populations. Methods: In a systematic search from PubMed, SCOPUS, Web of Sciences and Cochrane electronic databases, we collected relevant studies written in English and published until 30 October 2019. The population of included studies were apparently healthy subjects or individuals with obesity or obesity-related diseases. Observational studies that evaluated the association between DII® and indices of central obesity including WC or WHR were included. Results: Totally thirty-two studies were included; thirty studies were cross-sectional and two were cohort studies with 103071 participants. Meta-analysis of observational studies showed that higher DII® scores were associated with 1.81 cm increase in WC (Pooled weighted mean difference (WMD) = 1.813; CI: 0.785–2.841; p = 0.001). Also, a non-significant increase in the odds of having higher WC (OR = 1.162; CI: 0.95–1.43; p = 0.154) in the highest DII category was also observed. In subgroup analysis, the continent, dietary assessment tool and gender were the heterogeneity sources. Conclusion: The findings proposed that adherence to diets with high DII® scores was associated with increased WC. Further studies with interventional designs are necessary to elucidate the causality inference between DII® and central obesity indices.

Learning Language Levels in Students Accurate with a History Academic Achievement History

2017 ◽  
Vol 1 (2) ◽  
pp. 137
Author(s):  
Noorlela Binti Noordin ◽  
Abdul Razaq Ahmad ◽  
Anuar Ahmad
Keyword(s):  
Academic Achievement ◽  
Statistical Inference ◽  
Quantitative Data ◽  
Quantitative Methods ◽  
Descriptive Statistics ◽  
Language Test ◽  
The Subject ◽  
The Difference ◽  
Learning Language ◽  
The Relationship

This study was aimed to evaluate the Malay proficiency among students in Form Two especially non-Malay students and its relationship to academic achievement History. To achieve the purpose of the study there are two objectives, the first is to look at the difference between mean of Malay Language test influences min of academic achievement of History subject among non-Malay students in Form Two and the second is the relationship between the level of Malay proficiency and their academic achievement for History. This study used quantitative methods, which involved 100 people of Form Two non-Malay students in one of the schools in Klang, Selangor. This study used quantitative data were analyzed using descriptive statistics and statistical inference with IBM SPSS Statistics v22 software. This study found that there was a relationship between the proficiency of Malay language among non-Malay students with achievements in the subject of History. The implications of this study are discussed in this article.

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