Surgical innovation and safety: femoroacetabular impingement and the IDEAL collaborative framework:

Lee, Cara Beth

doi:10.1093/jhps/hnv074

Cited by 3 publications

(5 citation statements)

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“…On average, HA leads to significantly greater improvements than TPP in the treatment of FAIS in the short term. Future research should aim at investigating the long-term outcomes of HA for FAIS [ 47 ].…”

Section: Discussionmentioning

confidence: 99%

Arthroscopic hip surgery offers better early patient-reported outcome measures than targeted physiotherapy programs for the treatment of femoroacetabular impingement syndrome: a systematic review and meta-analysis of randomized controlled trials

Mahmoud

Takla

Meyer

et al. 2022

Journal of Hip Preservation Surgery

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Targeted physiotherapy programs (TPP), and surgery, using either open surgical hip dislocation or hip arthroscopy (HA), are the treatment modalities available for femoroacetabular impingement syndrome (FAIS). Randomized controlled trials have recently been performed to compare these treatment options. This review was performed to provide a focused synthesis of the available evidence regarding the relative value of treatment options. A systematic search was performed of Medline, Embase, Cochrane Library and ClinicalTrials.gov databases. Inclusion criteria were randomized controlled trials comparing treatment methods. The Cochrane Risk of Bias assessment tool (RoB2) was used to assess the selected studies. A meta-analysis was performed between homogenous studies. Four trials were identified including 749 patients (392 males). The mean ages of the cohorts ranged between 30.1 and 36.2 years old. Three hundred thirty-five patients underwent HA by 46 surgeons among all trials. Fifty-two patients crossed over from the TPP to the HA group. One of the trials was found to have a high risk of bias, while the other three were between low risk and some concerns. The iHOT-33 was the most commonly used patient-reported outcome measure followed by the HOS ADL and EQ-5D-5L. Others scores were also identified. Scores from two trials could be pooled together for meta-analysis. Apart from SF-12 and GRC, all other scores have shown significantly better outcomes with HA in comparison to TPP at 8- and 12-months follow-up points. HA offers better patient-reported outcomes than TPP for management of FAIS at 8- and 12-months follow-up.

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Section: Discussionmentioning

confidence: 99%

Arthroscopic hip surgery offers better early patient-reported outcome measures than targeted physiotherapy programs for the treatment of femoroacetabular impingement syndrome: a systematic review and meta-analysis of randomized controlled trials

Mahmoud

Takla

Meyer

et al. 2022

Journal of Hip Preservation Surgery

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“…Rather than summarise the implications of any or all of these claims, we refer the reader back to the full descriptions of the themes. Registries are widely supported in the literature [25,39]. 31 Some registries exist, but they are not always well used [39].…”

Section: A Conceptual Toolkitmentioning

confidence: 99%

“…Registries are widely supported in the literature [25,39]. 31 Some registries exist, but they are not always well used [39]. Registering innovation presents a practical problem since innovation is not well defined.…”

Section: A Conceptual Toolkitmentioning

confidence: 99%

“…Anything that sits in the transition zone between practice variations and experimental research [73] "A dynamic and continuous process involving the introduction of a new technology or technique that initiates a change in clinical practice" [29]:205 "A procedure that includes at least one of the following: (i) a different risk profile from standard practice, (ii) the need for new training, (iii) the use of a different anatomical approach, (iv) the potential for increased cost and (v) outcomes that have not yet been described" [39]:89 1 3…”

Section: Introductionmentioning

confidence: 99%

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Conceptualising Surgical Innovation: An Eliminativist Proposal

et al. 2019

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Improving surgical interventions is key to improving outcomes. Ensuring the safe and transparent translation of such improvements is essential. Evaluation and governance initiatives, including the IDEAL framework and the Macquarie Surgical Innovation Identification Tool have begun to address this. Yet without a definition of innovation that allows non-surgeons to identify when it is occurring, these initiatives are of limited value. A definition seems elusive, so we undertook a conceptual study of surgical innovation. This indicated common conceptual areas in discussions of (surgical) innovation, that we categorised alliteratively under the themes of "purpose" (about drivers of innovation), "place" (about contexts of innovation), "process" (about differentiating innovation), "product" (about tangible and intangible results of innovation) and "person" (about personal factors and viewpoint). These conceptual areas are used in varying-sometimes contradictory-ways in different discussions. Highlighting these conceptual areas of surgical innovation may be useful in clarifying what should be reported in registries of innovation. However our wider conclusion was that the term "innovation" carries too much conceptual baggage to inform normative inquiry about surgical practice. Instead, we propose elimination of the term "innovation" from serious discourse aimed at evaluation and regulation of surgery. In our view researchers, philosophers and policy-makers should consider what it is about surgical activity that needs attention and develop robust definitions to identify these areas: for our own focus on transparency and safety, this means finding criteria that can objectively identify certain risk profiles during the development of surgery.

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“… 11–15 It can also be defined as something with uncertain levels of risk. 16 Requirements for additional training 13 15 and the degree of evidence of safety and efficacy 17 18 have been used to determine how innovative an intervention is. However, some of these definitions are difficult to apply in practice.…”

Section: Introductionmentioning

confidence: 99%

Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review

Richards,

Cousins,

Scroggie

et al. 2024

BMJ Open

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ObjectivesThe development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, the types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design.DesignSecondary qualitative analysis of a systematic review.Data sourcesCitation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers.Eligibility criteriaStudies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers.Data extraction and synthesisAll relevant text was extracted. Three frameworks were developed, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage.Results48 articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous and was not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes.ConclusionIdentifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors’ rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision-making.

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Surgical innovation and safety: femoroacetabular impingement and the IDEAL collaborative framework:

Cited by 3 publications

References 54 publications

Arthroscopic hip surgery offers better early patient-reported outcome measures than targeted physiotherapy programs for the treatment of femoroacetabular impingement syndrome: a systematic review and meta-analysis of randomized controlled trials

Arthroscopic hip surgery offers better early patient-reported outcome measures than targeted physiotherapy programs for the treatment of femoroacetabular impingement syndrome: a systematic review and meta-analysis of randomized controlled trials

Conceptualising Surgical Innovation: An Eliminativist Proposal

Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review

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