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Books on the topic 'Randomised controlled trials (RCTs)'

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Published: 4 June 2021
Last updated: 30 January 2023

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1

Brass, Clinton T. Congress and program evaluation: An overview of randomized controlled trials (RCTs) and related issues. New York: Nova Science Publishers, 2008.

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2

Randomised controlled clinical trials. 2nd ed. Boston: Kluwer Academic Publishers, 1996.

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3

Bulpitt, Christopher J. Randomised Controlled Clinical Trials. Boston, MA: Springer US, 1996. http://dx.doi.org/10.1007/978-1-4615-6347-1.

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4

J, Hayes Richard, and Hayes Richard J. Cluster randomised trials. Boca Raton: Taylor & Francis, 2009.

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5

Song, F. Antimicrobial prophylaxis in colorectal surgery: A systematic review of randomised controlled trials. Alton: Core Research, on behalf of the NCCHTA, 1998.

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6

Eldridge, Sandra. A practical guide to cluster randomised trials in health services research. Chichester, West Sussex: John Wiley & Sons, 2011.

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7

Campbell, Michael J. How to design, analyse and report cluster randomised trials in medicine and health related research. Chichester, West Sussex: John Wiley & Sons, 2014.

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8

Torgerson, David J. Designing and running randomised trials in health, education, and the social sciences. New York: Palgrave Macmillan, 2008.

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9

Horsfall, Tessa Ann. What is the evidence to suggest that early supported discharge for patients following a stroke is a feasible alternative to usual care and rehabilitation of randomised controlled trials. Oxford: Oxford Brookes University, 2003.

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10

Robb, Sheri L., and Debra S. Burns. Randomized Controlled Trials in Music Therapy. Edited by Jane Edwards. Oxford University Press, 2015. http://dx.doi.org/10.1093/oxfordhb/9780199639755.013.14.

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Randomized controlled trials (RCTs) are experiments that compare two or more groups of participants, and participants are assigned to groups based on chance. Groups include an experimental intervention group that is being compared to a treatment as usual, a low dose or attention control condition, and/or a comparative treatment group. The purpose of randomization is to equalize groups on both known and unknown characteristics that may influence the outcome and the effectiveness of the intervention. This chapter describes how music therapists have used RCTs to demonstrate the effectiveness of music therapy interventions and services. Key strategies for implementing RCT designs are presented, and studies in music therapy that have used this design are reviewed.
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11

O'Cathain, Alicia. A Practical Guide to Using Qualitative Research with Randomized Controlled Trials. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198802082.001.0001.

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A Practical Guide to Using Qualitative Research with Randomized Controlled Trials focuses on qualitative research, emphasizing subjectivity, flexibility, open data collection, depth, and context, and randomized controlled trials (RCTs), emphasizing objectivity, standardization, measurement, and a key goal of bias reduction. The differences between the two methodologies make their combination an interesting ‘extreme case’ of mixed methods research. The book is about how to use qualitative research when preparing for, undertaking, or implementing the results of an RCT. The focus is on a range of designs, including pilot and pragmatic RCTs. The book focuses on health research because the majority of RCTs are undertaken in this field. It is written for researchers who are undertaking or planning to undertake qualitative research with RCTs. The book may also be useful to researchers leading RCTs and graduate students. It does not explain how to do qualitative research or how to do RCTs. The book focuses on how to undertake qualitative research in the specific context of RCTs. The book is divided into three parts. Part 2 offers the practical guidance promised within the title of the book. Each chapter focuses on key steps when undertaking qualitative research in the context of RCTs: writing a proposal, selecting research questions, collecting data, analysing data, integrating qualitative and quantitative components, and publishing. Part 1 sets the scene for the practical aspects. Part 3 focuses on the human beings we work closely with during research and offers practical advice to ensure these interactions are positive and fruitful.
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12

O'Cathain, Alicia. Rationales for using qualitative research with RCTs. Edited by Alicia O'Cathain. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198802082.003.0001.

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The focus of this chapter is on why researchers may want to use qualitative research with randomized controlled trials (RCTs) to generate evidence of effectiveness. The chapter starts by offering definitions of qualitative research and randomized controlled trials. It then moves on to exploring the types of interventions and contexts where qualitative research may be of most value. Ten rationales for combining qualitative research with RCTs are explored, followed by exploration of concerns researchers have expressed about this endeavour. Finally, the relevance of qualitative research to different fields of health research is considered.
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13

Strand, Vibeke, Jeremy Sokolove, and Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780199642489.003.0030.

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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, 'first-in-human' to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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14

Strand, Vibeke, Jeremy Sokolove, and Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199642489.003.0030_update_001.

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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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15

Strand, Vibeke, Jeremy Sokolove, and Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780199642489.003.0030_update_002.

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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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16

Thornicroft, Graham, and Vikram Patel, eds. Global Mental Health Trials. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199680467.001.0001.

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Global mental health is a dynamic field of global health; a core aspect of the story which has led to its emergence has been the conduct of randomised controlled trials (RCTs) evaluating innovative delivery systems of packages of care for mental disorders in low-resource settings. Global Mental Health Trials brings together many of the world's leading researchers active in the fields of RCTs in low- and medium-resource countries and settings related to improving mental health care. It presents clear and practical information about how to conduct such trials in these settings, along with critical methodological and ethical issues related to such trials, learning from the positive and negative experiences of expert scientists in many countries worldwide who have completed such trials. This online resource serves as a valuable resource for practitioners in mental health, including psychiatrists, psychiatric nurses nursing, psychologists, social workers, and occupational therapists, as well as researchers in the areas of psycho-social treatments in mental health, mental health services research, and programme and systems evaluation.
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17

Thornicroft, Graham, and Vikram Patel. The importance of trials for global mental health. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199680467.003.0001.

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This chapter sets the scene for the book as a whole by defining key terms, giving a brief history of randomized controlled trails (RCTs) in mental health research, explaining why RCTs can produce strong forms of evidence, and by locating trials within the translational research continuum. The authors describe criteria with which to judge the quality of pragmatic RCTs. Finally the authors discuss how the results of trials can be used to inform policy, investment, and service delivery decisions in low and middle income countries.
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18

Anjum, Rani Lill, and Stephen Mumford. What RCTs Do Not Show. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780198733669.003.0023.

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In this chapter we discuss how it is an uncontroversial norm of science that decisions should be based on evidence. There can be debate, however, on what counts as evidence and how we get from evidence to decision. The method of randomized controlled trials (RCTs) is now prominent in medical and social science. However, the method also has a number of weaknesses that are inherent to the design. There are some things that RCTs cannot test, while other interventions are well suited for the method. Among other consequences, it can be shown that the method structurally favours certain causal interventions over others.
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19

Kimpara, Satoko, Hannah Holt, Julianne Alsante, and Larry E. Beutler. Client, Therapist, and Treatment Variables. Edited by Sara Maltzman. Oxford University Press, 2016. http://dx.doi.org/10.1093/oxfordhb/9780199739134.013.14.

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Consideration of the client–therapist match as a contributor, predictor, and optimizer of therapeutic change is not new in the behavioral health field. Indeed, it has evolved from two interactive and co-acting histories: (a) changing practices in psychotherapy research and (b) corresponding changes in the way that clinicians have viewed the role of theory in their practices. In the past three and a half decades, research emphasis has changed to increasingly reflect the roles played by client diagnoses, brands of interventions, and the theories that underlie their use. This chapter reviews the history of psychotherapy research and randomized controlled trials (RCTs). It then describes a contemporary view of RCT design that attempts to incorporate contemporary research developments that are bringing together research and practice.
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20

Kropf, Nancy P., and Sherry M. Cummings. Motivational Interviewing. Oxford University Press, 2017. http://dx.doi.org/10.1093/acprof:oso/9780190214623.003.0008.

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In Chapter 8, “Motivational Interviewing: Evidence-Based Practice,” the research on the efficacy of motivational interviewing (MI) for achieving behavioral change in older adults is summarized and evaluated. Only meta-analyses and randomized controlled trails (RCTs) were included in the review. Fifteen RCTs were found that investigated the use of MI for enhancing behavioral change in older adults related to substance abuse/misuse, exercise, diet, and smoking. Beginning research on the use of MI with older clients suggests its efficacy for promoting behavioral change in this population. Results of randomized control trials reveal that MI is as effective as, or more effective than, other psychosocial interventions in fostering healthier behavior and improved mood. The studies discussed in this review were conducted in differing formats—face-to-face, telephone, and a combination of the two. The success of the telephone-based format, as well as the face-to-face approach, reveals the utility of MI interventions with homebound elders.
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21

Bulpitt, Christopher J. Randomised Controlled Clinical Trials. Springer London, Limited, 2012.

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22

Bulpitt, Christopher J. Randomised Controlled Clinical Trials. Springer, 2012.

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23

Bulpitt, Christopher J. Randomised Controlled Clinical Trials. Springer, 2013.

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24

Bulpitt, Christopher J. Randomised Controlled Clinical Trials. Springer London, Limited, 2013.

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25

Croswell, Jennifer M., Russell P. Harris, and Barnett S. Kramer. Cancer Screening. Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780190238667.003.0063.

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Screening has long been portrayed as an inherently beneficial activity that saves lives, rather than as a complex mixture of potential benefits and harms that must be carefully weighed for each modality. The early success of the Pap smear in reducing deaths from cervical cancer may have inadvertently fostered simplistic messaging about unqualified benefits of screening. Over time, large-scale randomized controlled trials (RCTs) of prostate and other cancers have highlighted the potential harms caused by mass screening programs (especially those related to overdiagnosis and unnecessary treatment) and have revealed the counterintuitive elements involved in evaluating such programs. The criteria for evaluation now extend beyond the performance criteria of the test itself to include the net balance of benefits, risks, and costs. PSA screening, widely used in the United States since the late 1980s, has now been removed from the list of routinely recommended procedures, based on evidence from RCTs.
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26

Simonoff, Emily. Intellectual impairment and neurogenetic disorders. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198739258.003.0025.

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Intellectual disability (ID) is a neurodevelopmental disorder commencing in early life in which both learning, typically measured with IQ tests, and adaptive functioning are impaired. Prevalence rates of ID vary widely, but converge around 3%. ID is associated with increased rates of all mental disorders but most with other neurodevelopmental disorders; hyperkinetic disorder is estimated to be increased 10-fold in ID, and rates of ADHD have been estimated to be approximately 5%. The full explanation for this association is uncertain, but shared genetic influences play an important role. Co-occurring ID should be considered when undertaking assessments for ADHD. The limited evidence base for treatment of ADHD with ID shows methylphenidate to be effective in randomized controlled trials (RCTs), but the effect sizes are about half those reported for children with average intellectual ability and with higher rates of non-serious adverse effects. No non-pharmacological interventions have been evaluated in RCTs.
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27

Chan, Jonathan, and Nigil Haroon. Treatment: NSAIDs. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780198734444.003.0020.

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Non-steroidal anti-inflammatory drugs (NSAIDs) constitute a diverse group of medications that inhibit prostaglandin synthesis. NSAIDs form the first-line pharmacological therapy in ankylosing spondylitis (AS). A number of randomized controlled trials (RCTs) support the efficacy of NSAIDs in reducing pain and improving patient function. Head-to-head comparisons have demonstrated equivalent effect of different NSAIDs in symptom control. The proposed disease-modifying potential of regular NSAID therapy is debatable and recent literature provides evidence to the contrary. Several safety concerns have been raised regarding long-term use of NSAIDs, especially an increase in cardiovascular risk. This chapter discusses the pharmacology, efficacy in treatment of AS, disease-modifying potential, and safety concerns of NSAIDs.
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28

Burns, Tom, and Mike Firn. Research and development. Edited by Tom Burns and Mike Firn. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780198754237.003.0029.

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This chapter covers the spectrum of routine monitoring, audit, service evaluation, and formal research. Routine monitoring is an essential task for all mental health professionals, and techniques to make it more palatable are explored, including using routine data for clinical supervision and monitoring team targets. Regular audit is described as an essential tool for logical service development and quality improvement. In the discussion of research, the importance of choosing the correct methodology and of paying attention to detail are stressed. In community psychiatry, sampling bias, regression to the mean, and the Hawthorne effect pose important risks. The hierarchy of research methods is outlined with randomized controlled trials (RCTs) at the top, preferably with either single- or double-blinding. Careful statistics and systematic reviews support evidence-based practice. In addition to experimental quantitative trials, there is a place for cohort and case control trials, as well as for qualitative trials to generate hypotheses.
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29

Miller, Sarah, Paul Connolly, Andy Biggart, Liam O'Hare, and Allen Thurston. Using Randomised Controlled Trials in Education. SAGE Publications, Limited, 2017.

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30

Jadad, Alejandro R., and Alejandro R. Jarad. Randomised Controlled Trials: A User's Guide. Bmj Publishing Group, 1998.

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31

Miller, Sarah, Paul Connolly, Andy Biggart, Liam O'Hare, and Allen Thurston. Using Randomised Controlled Trials in Education. SAGE Publications, Limited, 2017.

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32

Liam O′Hare, Sarah Miller, Paul Connolly, Andy Biggart, and Allen Thurston. Using Randomised Controlled Trials in Education. SAGE Publications, Limited, 2017.

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33

Fancourt, Daisy. An introduction to research. Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780198792079.003.0009.

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This chapter explores what we mean by ‘research’ in relation to arts in health: what its purpose is and how it differs from evaluation or audits. It questions whether arts in health research is ‘exceptional’ or different from other sorts of research in health, examining some of the most frequent misconceptions about research in this field. It also considers some of the debates around issues such as whether the arts can be assessed using randomized controlled trials (RCTs) and how quantitative research can capture the essence of an arts intervention. It explores different types of disciplinary working and proposes how the arts and health can be researched effectively together. Finally, the chapter provides top tips for research and recommends journals and conferences for keeping up-to-date with research findings.
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34

Matthews, J. N. S. An Introduction to Randomised Controlled Clinical Trials. A Hodder Arnold Publication, 2000.

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35

McCullough, Marjorie L., and Walter C. Willett. Diet and Nutrition. Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780190238667.003.0019.

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The formal study of diet, nutrition and cancer is still relatively young, with most epidemiological studies and randomized controlled trials (RCTs) having occurred in the last twenty to thirty years. Despite methodological challenges of studying diet and cancer in free-living populations, there is scientific consensus that overweight and obesity increase the risk of certain cancers and growing evidence that dietary patterns rich in vegetables, fruits, and whole grains and low in red and processed meat are associated with lower risk of colorectal cancer and total cancer mortality. Although it is more difficult to isolate the specific components of diet that affect risk, several key factors appear to play a role. Dietary composition appears to operate by both affecting energy intake and also independent of energy intake. Despite extensive research, evidence does not support an important impact of the macronutrient composition of diet on cancer risk.
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36

Moulton, Lawrence H., and Richard J. Hayes. Cluster Randomised Trials. Taylor & Francis Group, 2017.

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37

Moulton, Lawrence H., and Richard J. Hayes. Cluster Randomised Trials. Taylor & Francis Group, 2017.

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38

Moulton, Lawrence H., and Richard J. Hayes. Cluster Randomised Trials. Taylor & Francis Group, 2017.

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39

Cluster Randomised Trials. Taylor & Francis Group, 2017.

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40

Moulton, Lawrence H., and Richard J. Hayes. Cluster Randomised Trials. CRC Press LLC, 2022.

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41

Moulton, Lawrence H., and Richard J. Hayes. Cluster Randomised Trials. Taylor & Francis Group, 2017.

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42

Moulton, Lawrence H., and Richard J. Hayes. Cluster Randomised Trials. Taylor & Francis Group, 2009.

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43

Kropf, Nancy P., and Sherry M. Cummings. Psychoeducational and Social Support Interventions. Oxford University Press, 2017. http://dx.doi.org/10.1093/acprof:oso/9780190214623.003.0010.

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In Chapter 10, “Psychoeducational and Social Support Interventions: Evidence-Based Practice,” summarizes the results of meta-analyses, systematic reviews, and randomized controlled trials (RCTs) of psychoeducational and social support intervention studies with older adults and related populations. The majority of studies (n = 11) compared the effectiveness of interventions for deceasing depression and enhancing functioning among caregivers. Psychoeducational intervention studies were more prevalent than social support studies, and stronger evidence exists for the effectiveness of psychoeducational approaches. However, evidence does suggest that interventions types are useful in reducing caregiver depression and increasing caregiver support, well-being, and coping. Inconclusive results were found on caregiver burden. Four studies examined interventions focused on reducing depression, increasing well-being, or enhancing social functioning among older clients with cancer and other health/mental health issues. Positive results were found. Lack of intervention specificity, however, weakens practitioners and researchers’ ability to replicate the interventions included in these studies.
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44

Holden, Melanie A., Martin J. Thomas, and Krysia S. Dziedzic. Miscellaneous physical therapies. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199668847.003.0026.

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Miscellaneous physical therapies, such as assistive devices, thermotherapy, manual therapy, and electrotherapy are commonly used to treat patients with osteoarthritis (OA) in addition to written information and exercise. However, the evidence underpinning specific miscellaneous physical therapies is often limited, with small study sizes, heterogeneous populations, and differing study designs making it difficult to draw firm conclusions about their effectiveness. One or more miscellaneous physical therapies feature within 15 current clinical guidelines for OA. The specific types of physical therapies addressed are variable, as are their recommendations. There is most agreement for miscellaneous physical therapies in hand OA, with multiple guidelines addressing and consistently recommending joint protection, splinting, and thermotherapy in addition to core treatment. However these recommendations are predominantly based on a small number of randomized controlled trials (RCTs). Use of walking aids and footwear is commonly addressed and recommended for patients with hip and knee OA, although recommendations are predominantly based on expert opinion. Other physical therapies recommended for hip and knee OA range from orthoses to less conventional leech therapy. When a recommendation for a miscellaneous physical therapy is not made, it is commonly due to limited clinical evidence, rather than evidence of harm. Due to limited evidence and lack of consensus between clinical guidelines, for some therapies, use of specific miscellaneous physical therapies in clinical practice should be based upon the best available evidence, a holistic, individualized clinical assessment and shared decision-making with the patient. Further large-scale, high-quality RCTs would be useful to inform future guideline recommendations and clinical practice.
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45

Randomised Controlled Trials: Questions, Answers and Musings, 2nd Edition. 2nd ed. Wiley-Blackwell, 2007.

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46

Peacock, Janet L., and Sally M. Kerry. Presenting a randomised controlled trial. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780198599661.003.0012.

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47

Ethical issues in the design and conduct of randomised controlled trials. Alton: Core Research, on behalf of the NCCHTA, 1998.

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48

Essential Concepts in Clinical Research: Randomised Controlled Trials and Observational Epidemiology. Elsevier, 2018.

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49

Eldridge, Sandra, and Sally Kerry. Practical Guide to Cluster Randomised Trials in Health Services Research. Wiley & Sons, Incorporated, John, 2012.

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50

J, Prescott Robin, Health Technology Assessment Programme, and National Co-ordinating Centre for HTA (Great Britain), eds. Factors that limit the quality, number and progress of randomised controlled trials. Alton: Core Research on behalf of the NCCHTA, 1999.

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