scholarly journals From wealth to health: Evaluating microfinance as a complex intervention

Evaluation ◽  
2017 ◽  
Vol 23 (2) ◽  
pp. 209-225 ◽  
Author(s):  
Neil McHugh ◽  
Olga Biosca ◽  
Cam Donaldson
Keyword(s):  
Public Health ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Impact Evaluation ◽  
Ethical Issues ◽  
Complex Interventions ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Relevant Evidence ◽  
The Social

Innovative interventions that address the social determinants of health are required to help reduce persistent health inequalities. We argue that microcredit can act in this way and develop a conceptual framework from which to examine this. In seeking to evaluate microcredit this way we then examine how randomized controlled trials, currently considered as the ‘gold standard’ in impact evaluations of microcredit, compare with developments in thinking about study design in public health. This leads us to challenge the notion of trials as the apparent gold standard for microcredit evaluations and contend that the pursuit of trial-based evidence alone may be hampering the production of relevant evidence on microcredit’s public health (and other wider) impacts. In doing so, we introduce new insights into the global debate on microfinance impact evaluation, related to ethical issues in staging randomized controlled trials, and propose innovations on complementary methods for use in the evaluation of complex interventions.

Making a Difference

2018 ◽  
Author(s):  
Rani Lill Anjum ◽  
Stephen Mumford
Keyword(s):  
Randomized Controlled Trials ◽  
Comparative Studies ◽  
Gold Standard ◽  
Controlled Trials ◽  
Positive Difference ◽  
Randomized Controlled ◽  
Difference Making ◽  
Making A Difference ◽  
Difference Makers ◽  
Trial Intervention

One view of what links a cause to an effect is that causes make a difference to whether or not the effect is produced. This assumption is behind comparative studies, such as the method of randomized controlled trials, aimed at showing whether a trial intervention makes a positive difference to outcomes. Comparative studies are regarded as the gold standard in some areas of research but they are also problematic. There can be causes that make no difference and some difference-makers that are not causes. This indicates that difference-making should be taken as a symptom of causation: a feature that accompanies it in some, though not all, cases. Symptoms can be useful in the discovery of causes but they cannot be definitive of causation.

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

scholarly journals Critical analysis of the drafting of physical therapy randomized controlled trials published in Portuguese

2016 ◽  
Vol 29 (2) ◽  
pp. 421-427
Author(s):  
Ercole da Cruz Rubini ◽  
Fabio Dutra Pereira ◽  
Renato Sobral Monteiro-Junior ◽  
Patricia Zaidan ◽  
Cintia Pereira de Souza ◽  
...  
Keyword(s):  
Physical Therapy ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Critical Analysis ◽  
Physical Therapists ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
Methodological Procedures

Abstract Introduction: randomized controlled trials are high quality studies. Many problems related to the drafting of these studies have been identified and consequently various national and international journals, in an attempt to improve this writing, have adopted the Consolidated Standards of Reporting Trials recommendations. Regarding the studies written specifically by physical therapists, until now, the quality of the drafting in Portuguese has been unknown. Aim: To critically analyze the drafting of RCTs in the area of physical therapy, published in Portuguese, in relation to the CONSORT recommendations. Materials and Methods: On 17th Oct, 2012, 548 RCTs in Portuguese were recovered from the MEDLINE and PEDro databases, which were divided among four evaluators who, after reading the abstracts, selected those related to physical therapy. Of these studies, 78 RCTs were related to physical therapy, which were divided among the four evaluators for the analysis of the drafting according to the CONSORT recommendations. The four evaluators who participated in this study previously obtained a median kappa above 70% when their analyses were compared to the analyses of the evaluator considered the gold standard due to having greater experience. Results: The quantity of items of the CONSORT recommendations according to year of publication was very small, corresponding to a mean of 43% of the items in the articles analyzed. Conclusion: The results make very clear the need to improve the quality of the drafting of the RCTs related to physical therapy in Portuguese and to include more rigorous methodological procedures, such as sample size, randomization and blinding. The dissemination and adoption of the CONSORT recommendations by physical therapy researchers would, without doubt, be a big step towards improving this quality.

scholarly journals Some Questions of Ethics in RCTs

2021 ◽  
Author(s):  
Reetika Khera
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Human Subjects ◽  
Belmont Report ◽  
Institutional Review Boards ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Institutional Review ◽  
Areas Of Concern

Questions of ethics in Randomized Controlled Trials (RCTs) in development economics need greater attention and a wider perspective. RCTs are meant to be governed by the three principles laid out in the Belmont Report, but often violated them, e.g. when local laws are flouted. In other cases, the framework of the Belmont Report itself has proved inadequate: for instance, when there are unintended outcomes or adverse events for which no-one is held accountable. Primarily using RCTs conducted in India, this paper highlights eight areas of concern. RCTs also have a disproportionate influence on shaping research agendas and on policy. Though ethical issues have been raised, there has been little engagement from the RCT community – a manifestation of its power in the profession. As current safeguards (such as oversight by Institutional Review Boards) have failed to protect human subjects, the concluding section discusses possible ways to resolve these issues.

Randomized controlled trials

2020 ◽  
pp. 187-218
Author(s):  
Sube Banerjee ◽  
Rod S. Taylor ◽  
Jennifer Hellier
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trials ◽  
Complex Interventions ◽  
Controlled Trials ◽  
Key Factors ◽  
Randomized Controlled ◽  
Study Population ◽  
Primary Hypothesis ◽  
Definition Of

This chapter on randomized controlled trials (RCTs) considers some of the key factors in the design, conduct, analysis, and interpretation of RCTs. The chapter provides an overview of what constitutes an RCT and why they are needed. The chapter also provides an overview of the major practical elements of the design and conduct of RCTs, including undertaking a background review of literature, the need for formulation of a clear primary hypothesis and objective, selection and definition of the study population, collecting outcomes at baseline and follow-up, and appropriate methods of statistical analysis and inference. The chapter concludes with a consideration of the need for clinical trial units, complex interventions, and alternative RCT designs.

scholarly journals Evidence-based policies, nudge theory and Nancy Cartwright: a search for causal principles

2020 ◽  
pp. 1-20
Author(s):  
ALEJANDRO HORTAL
Keyword(s):  
Public Policy ◽  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Policy Interventions ◽  
Nancy Cartwright ◽  
Instrumental View

Abstract Nancy Cartwright argues that evidence-based policies should not only rely on randomized controlled trials (RCTs) to test their effectiveness – they should also use horizontal and vertical searches to find support factors and causal principles that help define how those policies work. This paper aims at analyzing Cartwright's epistemology regarding evidence-based policies and their use of RCTs while applying her findings to current research involving nudges as behavioral public policy interventions. Holding a narrowly instrumental view of rationality, nudge theory tends to neglect other expressive components. Policymakers, in their quest for causal principles, should consider the expressive rationality of individuals in their research. This inclusion would not only increase the effectiveness of nudges, but also address some ethical issues related to people's autonomy when targeted by these interventions.

scholarly journals Critical and Comprehensive Ethical Analysis on Pragmatic Randomized Controlled Trials

2020 ◽  
Author(s):  
Soaad Hossain
Keyword(s):  
Medical Ethics ◽  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Ethical Analysis ◽  
Ethical Framework ◽  
Controlled Trials ◽  
Research Practice ◽  
Randomized Controlled ◽  
Regulatory Frameworks

The interest of pragmatic randomized controlled trials continues to increase as they are much better suited for studies of how to get medical and health services out into wider practice. However, despite the advantage that such trials have, there are several ethical issues and medical ethics issues that persist with the trial. The ethical and medical ethics issues involve research-practice distinction, consent, disclosure, vulnerable populations, oversight, ethical principles, ethical framework, regulatory frameworks, and conflicts of interest. Through performing an elaborate literature review and analyzing claims and arguments made within the literature, we will provide a critical and comprehensive ethical analysis on pragmatic randomized controlled trials, and we will begin the discussion on conflicts of interest in pragmatic RCTs, arguing that conflicts of interest occur in pragmatic RCTs.

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