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Designing and Delivering a DTx Clinical Research Program: No Need to Re-invent the Wheel
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Colin A. Espie, Alasdair L. Henry
Clinical guidelines are systematically developed statements to assist practitioner and patient decisions about the appropriate healthcare for a specific clinical circumstance and are the established means by which evidence-based medicine is implemented (e.g., Institute of Medicine, 2011; Woolf et al., 1999). Therefore, if DTx companies are serious about advancing evidence-based care, they should be developing their clinical research program with guideline care in mind. Given the scalability of SaMD interventions, attention should be paid to how the standards, methods, and systems of international guidelines are developed (Kredo et al., 2016). The bar to entry of a genuinely evidence-based therapeutic is getting higher. The most recent definition (Institute of Medicine, 2011) is that Clinical guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.
Research in the clinical setting
Published in Robert Jones, Fiona Jenkins, Managing and Leading in the Allied Health Professions, 2021
Clinical guidelines are a growing and integral part of evidence-based practice. Guidelines consist of a set of systematically developed statements aimed at assisting the practitioner and the patient in making appropriate decisions about individual healthcare. The key features of guideline developments include the rigorous and systematic searching, reading and appraisal of the evidence and taking into account the hierarchy of evidence. Also integral to guideline development is the consideration of what the implications of the evidence are for clinical practice, i.e. is the evidence relevant for a local population or specific circumstances? It also involves weighing up the strength of the evidence and assessing the benefits, risks, costs and possible harm of implementing the evidence into practice. Clinical guidelines should provide a tool containing a description of the best available evidence and recommendations for practice and a resource for patients providing the basis for patient/clinician shared decision making. Guidelines should be used and interpreted locally in order to improve patient care. For a detailed explanation of evidence-based practice, the reader is referred to Herbert et al., 2005.19
Patient safety and substantive English medical law
Published in John Tingle, Clayton Ó Néill, Morgan Shimwell, Global Patient Safety, 2018
Has this improved patient safety? It is difficult to know, but the intuitive answer would seem to be yes. Questionable practices, hallowed by mere convention, can now be questioned. The requirement that a practice, to be defensible, has to be capable of standing up to scrutiny, has had the effect of enhancing the status of evidence-based medicine.14 The process of drafting an authoritative clinical guideline necessarily involves an examination of the literature and a canvassing of opinions from a variety of experts. There is much less room, in the world of evidence-based medicine endorsed by Bolitho, for dangerous mavericks.
Review of clinical practice guidelines relating to cognitive assessment in stroke
Published in Disability and Rehabilitation, 2022
David McMahon, Clayton Micallef, Terence J. Quinn
While stroke care has advanced hugely in recent decades, some elements are better considered and evidenced than others. Explicit guidance on hyperacute stroke therapy, underpinned by robust primary research has transformed stroke care. At present, the assessment of cognition in stroke is lacking useful guidance but this partly reflects the availability of original research in this area. Where recommendations are available, the guidelines tend to be of high quality but may lack clinical utility. Given the myriad of stroke cognitive presentations, clinician variation in management and differences in healthcare settings, prescriptive guidance on the exact approach to cognitive testing may not be suitable. Clinical guidelines are just that, guidance and are not a substitute for clinical judgement or consideration of patient preferences. However, further primary research on cognitive assessment would allow the next iterations of guidelines to offer a stronger evidence base that could hopefully improve the approach to assessment.
Capacity Building for Health Care Workers and Support Staff in Pediatric Emergency Triage Assessment and Treatment (ETAT) at Primary Health Care Level in Resource Limited Settings: Experiences from Malawi
Published in Comprehensive Child and Adolescent Nursing, 2022
Maureen Daisy Majamanda, Mtisunge Joshua Gondwe, Thomasena O’Byrne, Martha Makwero, Alfred Chalira, Norman Lufesi, Queen Dube, Nicola Desmond
Effective delivery of any training requires a guideline to ensure all relevant content is covered. Clinical guidelines are a vital tool for health practitioners in improving the quality of health care delivery across various clinical situations (Farquhar et al., 2002; Reddy et al., 2015). The process of reviewing and developing the training manuals involved experts from the field of pediatrics and child health from different sectors. These experts formed a working group as they represented all those that would implement the guidelines (Maher & Ford, 2017). The training manual acts as a reference guide in how content should be organized and delivered to a group of participants. McLachlan et al. (2020) assert that clinical guidelines standardize care and enable delivery of evidence-based practice. When successfully implemented, clinical guidelines decrease variation within the everyday clinical practice and, as a result, optimize the health of the patients and communities in which the guidelines have been adopted (Reddy et al., 2015).
A synthesis and appraisal of clinical practice guidelines, consensus statements and Cochrane systematic reviews for the management of focal spasticity in adults and children
Published in Disability and Rehabilitation, 2022
Gavin Williams, Barby J. Singer, Stephen Ashford, Brian Hoare, Tandy Hastings-Ison, Klemens Fheodoroff, Steffen Berwick, Edwina Sutherland, Bridget Hill
The purpose of clinical guidelines, recommendations and reviews is to inform and assist clinicians towards delivering best practice. However, in reality, the existence of multiple guidelines may be confusing and impede translation of evidence into clinical practice. As Table 5 demonstrates, the quality of the guidelines included in this review varied considerably. Furthermore, some guidelines contradict each other. This raises two challenges: firstly, some guidelines recommend against aspects of focal spasticity management that others endorse (Table 3), such as use of the MAS or Barthel Index. Secondly, recommendations in specific spasticity guidelines are not necessarily aligned with other condition-specific guidelines. This first challenge can be addressed by the generation of a summary of the most common guideline recommendations as outlined in this review.