GLORIA

GEOMAR Library Ocean Research Information Access

X

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
  • 1
    Online Resource
    Online Resource
    Beyond the RCT: When are Randomized Trials Unnecessary for New Therapeutic Devices, and What Should We Do Instead?
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Annals of Surgery Vol. 275, No. 2 ( 2022-02), p. 324-331
    Details
    In: Annals of Surgery, Ovid Technologies (Wolters Kluwer Health), Vol. 275, No. 2 ( 2022-02), p. 324-331
    Abstract: The aim of this study was to develop an evidence-based framework for evaluation of therapeutic devices, based on ethical principles and clinical evidence considerations Summary Background Data: Nearly all medical products which do not work solely through chemical action are regulated as medical devices. Their huge range of purposes, mechanisms of action and risks pose challenges for regulation. High-profile implantable device failures have fuelled concerns about the level of clinical evidence needed for market approval. Calls for more rigorous evaluation lack clarity about what kind of evaluation is appropriate, and are commonly interpreted as meaning more randomized controlled trials (RCTs). These are valuable where devices are genuinely new and claim to offer measurable therapeutic benefits. Where this is not the case, RCTs may be inappropriate and wasteful. Methods: Starting with a set of ethical principles and basic precepts of clinical epidemiology, we developed a sequential decision-making algorithm for identifying when an RCT should be performed to evaluate new therapeutic devices, and when other methods, such as observational study designs and registry-based approaches, are acceptable. Results: The algorithm clearly defines a group of devices where an RCT is deemed necessary, and the associated framework indicates that an IDEAL 2b study should be the default clinical evaluation method where it is not. Conclusions: The algorithm and recommendations are based on the principles of the IDEAL-D framework for medical device evaluation and appear eminently practicable. Their use would create a safer system for monitoring innovation, and facilitate more rapid detection of potential hazards to patients and the public.
    Type of Medium: Online Resource
    ISSN: 0003-4932 , 1528-1140
    URL: Article
    DOI: 10.1097/SLA.0000000000005053
    RVK:
    XA 23900
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2641023-0
    detail.hit.zdb_id: 2002200-1
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 2
    Online Resource
    Online Resource
    The “architect analogy” of evidence‐based practice: Reconsidering the role of clinical expertise and clinician experience in evidence‐based health care
    Wiley ; 2018
    In:  Journal of Evidence-Based Medicine Vol. 11, No. 4 ( 2018-11), p. 219-226
    Details
    In: Journal of Evidence-Based Medicine, Wiley, Vol. 11, No. 4 ( 2018-11), p. 219-226
    Abstract: The role of expertise in evidence‐based medicine (EBM) and practice (EBP) has long been debated. In the early years of the EBP movement, the role of expertise and experience were diminished in clinical decision‐making. However, the concepts of EBP are evolving. A more nuanced view of the value of clinician expertise, based on experience and clinical judgement, has emerged. This article proposes that clinical expertise does not belong within the evidence hierarchy's decision‐making pyramid as the lowest form of evidence, but rather alongside it, representing a complementary source of knowledge that supports the processes of EBP. An “Architect Analogy of EBP” is proposed as a new model by which to describe this relationship. In this analogy, the clinician's use of expertise is likened to the role of an architect, using evidence as building blocks in the construction of the client's edifice, representing the patients’ health and wellbeing. Much as an architect carefully designs the edifice in consultation with the client's needs and preferences, choosing appropriate material (evidence), rejecting faulty material, and ensuring construction stays on course, the clinician must sort through a plethora of sometimes contradictory evidence, evaluate its merits and appropriateness for the patients’ unique biopsychosocial circumstances and values, and monitor the effects of interventions on patients’ health and wellbeing. The expertise of practitioners, as the architects of EBP, is an important supporting source of knowledge that facilitates the “Five Steps of EBP,” informs and facilitates EBP, and supports patient‐centred care.
    Type of Medium: Online Resource
    ISSN: 1756-5383 , 1756-5391
    URL: Issue
    URL: Article
    DOI: 10.1111/jebm.2018.11.issue-4
    DOI: 10.1111/jebm.12321
    Language: English
    Publisher: Wiley
    Publication Date: 2018
    detail.hit.zdb_id: 2474496-7
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 3
    Online Resource
    Online Resource
    Examining the empirical evidence for IDEAL 2b studies: the effects of preceding prospective collaborative cohort studies on the quality and impact of subsequent randomized controlled trials of surgical innovations – protocol for a systematic review and case–control analysis
    BMJ ; 2022
    In:  BMJ Surgery, Interventions, & Health Technologies Vol. 4, No. 1 ( 2022-11), p. e000120-
    Details
    In: BMJ Surgery, Interventions, & Health Technologies, BMJ, Vol. 4, No. 1 ( 2022-11), p. e000120-
    Abstract: Randomized controlled trials (RCTs) in surgery face methodological challenges, which often result in low quality or failed trials. The Idea, Development, Exploration, Assessment and Long-term (IDEAL) framework proposes preliminary prospective collaborative cohort studies with specific properties (IDEAL 2b studies) to increase the quality and feasibility of surgical RCTs. Little empirical evidence exists for this proposition, and specifically designed 2b studies are currently uncommon. Prospective collaborative cohort studies are, however, relatively common, and might provide similar benefits. We will, therefore, assess the association between prior ‘IDEAL 2b-like’ cohort studies and the quality and impact of surgical RCTs. We propose a systematic review using two parallel case–control analyses, with surgical RCTs as subjects and study quality and journal impact factor (IF) as the outcomes of interest. We will search for surgical RCTs published between 2015 and 2019 and and prior prospective collaborative cohort studies authored by any of the RCT investigators. RCTs will be categorized into cases or controls by (1) journal (IF ≥or 〈 5) and (2) study quality (PEDro score ≥or 〈 7). The case/control OR of exposure to a prior ‘2b like’ study will be calculated independently for quality and impact. Cases will be matched 1: 1 with controls by year of publication, and confounding by peer-reviewed funding, author academic affiliation and trial protocol registration will be examined using multiple logistic regression analysis. This study will examine whether preparatory IDEAL 2b-like studies are associated with higher quality and impact of subsequent RCTs.
    Type of Medium: Online Resource
    ISSN: 2631-4940
    URL: Article
    DOI: 10.1136/bmjsit-2021-000120
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2973060-0
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 4
    Online Resource
    Online Resource
    Reporting guideline for the early-stage clinical evaluation of decision support systems driven by artificial intelligence: DECIDE-AI
    Springer Science and Business Media LLC ; 2022
    In:  Nature Medicine Vol. 28, No. 5 ( 2022-05), p. 924-933
    Details
    In: Nature Medicine, Springer Science and Business Media LLC, Vol. 28, No. 5 ( 2022-05), p. 924-933
    Type of Medium: Online Resource
    ISSN: 1078-8956 , 1546-170X
    URL: Article
    DOI: 10.1038/s41591-022-01772-9
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 1484517-9
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 5
    Online Resource
    Online Resource
    Evidence-Based Evaluation of Practice and Innovation in Rehabilitation Using the IDEAL-Physio Framework
    Elsevier BV ; 2017
    In:  Archives of Physical Medicine and Rehabilitation Vol. 98, No. 10 ( 2017-10), p. e66-
    Details
    In: Archives of Physical Medicine and Rehabilitation, Elsevier BV, Vol. 98, No. 10 ( 2017-10), p. e66-
    Type of Medium: Online Resource
    ISSN: 0003-9993
    URL: Article
    DOI: 10.1016/j.apmr.2017.08.206
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2017
    detail.hit.zdb_id: 2040858-4
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 6
    Online Resource
    Online Resource
    Acute evening high-intensity interval training may attenuate the detrimental effects of sleep restriction on long-term declarative memory
    Oxford University Press (OUP) ; 2023
    In:  SLEEP Vol. 46, No. 7 ( 2023-07-11)
    Details
    In: SLEEP, Oxford University Press (OUP), Vol. 46, No. 7 ( 2023-07-11)
    Abstract: Recent evidence shows that a nap and acute exercise synergistically enhanced memory. Additionally, human-based cross-sectional studies and animal experiments suggest that physical exercise may mitigate the cognitive impairments of poor sleep quality and sleep restriction, respectively. We evaluated whether acute exercise may offset sleep restriction’s impairment of long-term declarative memory compared to average sleep alone. A total of 92 (82% females) healthy young adults (24.6 ± 4.2 years) were randomly allocated to one of four evening groups: sleep restriction only (S5, 5–6 h/night), average sleep only (S8, 8–9 h/night), high-intensity interval training (HIIT) before restricted sleep (HIITS5), or HIIT before average sleep (HIITS8). Groups either followed a 15-min remote HIIT video or rest period in the evening (7:00 p.m.) prior to encoding 80 face-name pairs. Participants completed an immediate retrieval task in the evening. The next morning a delayed retrieval task was given after their subjectively documented sleep opportunities. Long-term declarative memory performance was assessed with the discriminability index (dʹ) during the recall tasks. While our results showed that the dʹ of S8 (0.58 ± 1.37) was not significantly different from those of HIITS5 (−0.03 ± 1.64, p = 0.176) and HIITS8 (−0.20 ± 1.28, p = 0.092), there was a difference in dʹ compared to S5 (−0.35 ± 1.64, p = 0.038) at the delayed retrieval. These results suggest that the acute evening HIIT partially reduced the detrimental effects of sleep restriction on long-term declarative memory.
    Type of Medium: Online Resource
    ISSN: 0161-8105 , 1550-9109
    URL: Article
    DOI: 10.1093/sleep/zsad119
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
    detail.hit.zdb_id: 2056761-3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 7
    Online Resource
    Online Resource
    Gray literature: An important resource in systematic reviews
    Wiley ; 2017
    In:  Journal of Evidence-Based Medicine Vol. 10, No. 3 ( 2017-08), p. 233-240
    Details
    In: Journal of Evidence-Based Medicine, Wiley, Vol. 10, No. 3 ( 2017-08), p. 233-240
    Abstract: Systematic reviews aide the analysis and dissemination of evidence, using rigorous and transparent methods to generate empirically attained answers to focused research questions. Identifying all evidence relevant to the research questions is an essential component, and challenge, of systematic reviews. Gray literature, or evidence not published in commercial publications, can make important contributions to a systematic review. Gray literature can include academic papers, including theses and dissertations, research and committee reports, government reports, conference papers, and ongoing research, among others. It may provide data not found within commercially published literature, providing an important forum for disseminating studies with null or negative results that might not otherwise be disseminated. Gray literature may thusly reduce publication bias, increase reviews’ comprehensiveness and timeliness, and foster a balanced picture of available evidence. Gray literature's diverse formats and audiences can present a significant challenge in a systematic search for evidence. However, the benefits of including gray literature may far outweigh the cost in time and resource needed to search for it, and it is important for it to be included in a systematic review or review of evidence. A carefully thought out gray literature search strategy may be an invaluable component of a systematic review. This narrative review provides guidance about the benefits of including gray literature in a systematic review, and sources for searching through gray literature. An illustrative example of a search for evidence within gray literature sources is presented to highlight the potential contributions of such a search to a systematic review. Benefits and challenges of gray literature search methods are discussed, and recommendations made.
    Type of Medium: Online Resource
    ISSN: 1756-5383 , 1756-5391
    URL: Issue
    URL: Article
    DOI: 10.1111/jebm.2017.10.issue-3
    DOI: 10.1111/jebm.12266
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 2474496-7
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 8
    Online Resource
    Online Resource
    Grey literature: An important resource in systematic reviews
    Wiley ; 2017
    In:  Journal of Evidence-Based Medicine
    Details
    In: Journal of Evidence-Based Medicine, Wiley
    Type of Medium: Online Resource
    ISSN: 1756-5391
    URL: Article
    DOI: 10.1111/jebm.12265
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 2474496-7
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 9
    Online Resource
    Online Resource
    The effectiveness of intratissue percutaneous electrolysis for the treatment of tendinopathy: a systematic review
    Academy of Science of South Africa ; 2022
    In:  South African Journal of Sports Medicine Vol. 34, No. 1 ( 2022-05-12)
    Details
    In: South African Journal of Sports Medicine, Academy of Science of South Africa, Vol. 34, No. 1 ( 2022-05-12)
    Abstract: Background: Tendinopathy is highly prevalent in the general public and common in athletes. It makes up nearly 50% of all sport injuries. A number of treatment techniques with varying evidence of effectiveness are currently available. Intratissue percutaneous  electrolysis (EPI) is one such modality, however little consensus exists for EPI’s efficacy or the most effective treatment parameters. Objective: To review and appraise available evidence for Intratissue Percutaneous Electrolysis (EPI) in the treatment of tendinopathy, examining the effectiveness of EPI in conjunction with other modalities and identifying the strengths and limitations of the evidence base for EPI in order to make evidence-based recommendation for future studies of EPI. Methods: PubMed, Embase and Scopus were searched with keywords related to EPI and tendinopathy. Grey literature searches were conducted with Embase, OpenGrey, and ProQuest. Extensive citation searching was undertaken. Randomised controlled trials (RCTs), uncontrolled and observational studies of the application of EPI in patients aged 18-65 years with Magnetic Resonance Imaging (MRI) or clinical Ultrasonography (US) confirmed diagnosis of tendinopathy were eligible. Results: Eleven studies met inclusion criteria: six randomised control trials (RCTs) and five uncontrolled studies. Clinical trials of EPI as an adjunct modality with physical therapy reporting greater decreased pain and return to function than treatment with physical therapy alone. The evidence for EPI is limited and influenced by small sample sizes, varying treatment protocols, clinical heterogeneity and high risk of bias. Conclusion: It is currently not possible to conclude that EPI is an effective modality for the treatment of tendinopathy. RCTs with clearly described EPI treatment protocols, larger sample sizes and intervention reporting sufficient to support reproducibility are needed to determine the effectiveness of EPI for the treatment of tendinopathy.
    Type of Medium: Online Resource
    ISSN: 2078-516X , 1015-5163
    URL: Article
    DOI: 10.17159/2078-516X/2022/v34i1a12754
    Language: Unknown
    Publisher: Academy of Science of South Africa
    Publication Date: 2022
    detail.hit.zdb_id: 2475947-8
    detail.hit.zdb_id: 2709959-3
    SSG: 31
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 10
    Online Resource
    Online Resource
    Developing Overhand Throwing Skills for a Child With Autism With a Collaborative Approach in School-Based Therapy
    Ovid Technologies (Wolters Kluwer Health) ; 2017
    In:  Pediatric Physical Therapy Vol. 29, No. 3 ( 2017-07), p. 262-269
    Details
    In: Pediatric Physical Therapy, Ovid Technologies (Wolters Kluwer Health), Vol. 29, No. 3 ( 2017-07), p. 262-269
    Abstract: This case report presents an interdisciplinary approach in school-based therapy, combining physical therapy and applied behavior analysis to improve the motor skills and the participation in recreational activities of a child with autism spectrum disorder. Methods: A 9-year-old child with autism spectrum disorder participated in a 20-week gross motor intervention designed to improve the child's overhand throwing ability, which included weekly physical therapy instruction and daily throwing trials using applied behavior analysis approaches. Results: The child demonstrated gains in throwing accuracy, significant gains on measures of the Bruininks-Oseretsky Test of Motor Proficiency-2, the Test of Gross Motor Development-2, and the School Function Assessment. Conclusion: This unique approach in school-based therapy demonstrates effective strategies for a multidisciplinary intervention to improve motor learning skills and participation in recreational activities in the school setting.
    Type of Medium: Online Resource
    ISSN: 0898-5669
    URL: Article
    DOI: 10.1097/PEP.0000000000000405
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
    detail.hit.zdb_id: 2071155-4
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...