An Update on the Appropriate Role for Hyperbaric Oxygen: Indications and Evidence

Fife, Caroline E.; Eckert, Kristen A.; Carter, Marissa J.

doi:10.1097/prs.0000000000002714

Cited by 50 publications

(45 citation statements)

References 43 publications

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“…With EHRs, they have become more user friendly and can automatically calculate risks and healing likelihoods for clinicians to use at POC. With the WHI, clinicians participating in our consortium and the USWR are not yet provided the score at POC, as further dialogue is needed to be certain what the effect of the WHI would be on clinical practice . Furthermore, probabilistic estimations need to be useful to improve decision making .…”

Section: Discussionmentioning

confidence: 99%

A new approach to clinical research: Integrating clinical care, quality reporting, and research using a wound care network‐based learning healthcare system

Serena

Fife

Eckert

et al. 2017

Wound Repair Regeneration

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The disparity between ideal evidence from randomized controlled trials and real-world evidence in medical research has prompted the United States Food and Drug Administration to consider the use of real-world data to better understand safety and effectiveness of new devices for a broader patient population and to prioritize real-world data in regulatory decision making. As the healthcare system transitions from volume- to value-based care, there is a growing need to harness the power of real-world data to change the paradigm for wound care clinical research and enable more generalizable clinical trials. This paper describes the implementation of a network-based learning healthcare system by a for-profit consortium of wound care clinics that integrates wound care management, quality improvement, and comparative effectiveness research, by harnessing structured real-world data within a purpose-built electronic health record at the point of care. Centers participating in the consortium submit their clinical data and quality measures to a qualified clinical data registry for wound care, enabling benchmarking of their data across this national network. The common definitional framework of the purpose-built electronic health record and the 21 wound-specific quality measures help to standardize the potential sources of bias in real-world data, making the consortium data useful for comparative effectiveness research. This consortium can transform wound care clinical research and raise the standards of care, while helping physicians achieve success with the Merit-Based Incentive Payment System.

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Section: Discussionmentioning

confidence: 99%

A new approach to clinical research: Integrating clinical care, quality reporting, and research using a wound care network‐based learning healthcare system

Serena

Fife

Eckert

et al. 2017

Wound Repair Regeneration

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“…The WHI can create matched cohorts for prospective or retrospective CER using USWR data for: diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), pressure ulcers (of the heels vs. the rest of the body), surgical wounds, traumatic wounds, amputations, and arterial ulcers . The predictive likelihood of healing has so far not been revealed to providers, absent a national discussion of the possible unintended consequences of making such predictions available …”

Section: Minimizing Information and Analytical Biasmentioning

confidence: 99%

“…31 The predictive likelihood of healing has so far not been revealed to providers, absent a national discussion of the possible unintended consequences of making such predictions available. 56 Other bias related to interpretation and analysis of outcomes data in CER can be mitigated by a well-defined statistical analysis plan ( Table 1) that considers the following factors: patient characteristics, exposure/treatment, endpoints/outcomes, covariates, time, and the potential for bias (when sensitivity analyses and/or bias analyses are performed). 10…”

Section: Minimizing Information and Analytical Biasmentioning

confidence: 99%

Harnessing electronic healthcare data for wound care research: Standards for reporting observational registry data obtained directly from electronic health records

Fife

Eckert

2017

Wound Repair Regeneration

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The United States Food and Drug Administration will consider the expansion of coverage indications for some drugs and devices based on real‐world data. Real‐world data accrual in patient registries has historically been via manual data entry from the medical chart at a time distant from patient care, which is fraught with systematic error. The efficient automated transmission of data directly from electronic health records is replacing this labor‐intensive paradigm. However, real‐world data collection is unfamiliar. The potential sources of bias arising from the source of data and data accrual, documentation, and aggregation have not been well defined. Furthermore, the technological aspects of data acquisition and transmission are less transparent. We explore opportunities for harnessing direct‐from‐electronic health record registry reporting and propose the ABCs of Registries (Analysis of Bias Criteria of Registries), which are an evaluation framework for publications to minimize potential bias of real‐world data obtained directly from an electronic health record method. These standards are based on a point‐of‐care data documentation process using a common definitional framework and data dictionaries. By way of example, we describe a wound registry obtained directly from electronic health records. This qualified clinical data registry minimizes bias by ensuring complete and accurate point‐of‐care data capture, standardizes usual care linked to quality reporting, and prevents post‐hoc vetting of outcomes. The resulting data are of high quality and integrity and can be used for comparative effectiveness research in wound care. In this way, the effort needed to succeed with the Quality Payment Program is leveraged to obtain the real‐world data needed for comparative effectiveness research.

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“…Among the advanced therapeutic interventions for wounds, HBOT has the unique ability to improve tissue hypoxia, reduce pathological inflammation, and mitigate ischemia-reperfusion injury. The majority of the conditions in which HBOT has been used are known to have a few successful alternative treatments, but the morbidity and mortality associated with the failure of these alternative treatments remains significant [14].…”

Section: Introductionmentioning

confidence: 99%

Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol

Lopes

Dias

Corrêa

et al. 2019

Preprint

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Background: Diabetic limb ulcers are highly prevalent and contribute to a significant increase in cost for the treatment of these patients in health services. However, healing of these wounds is a major health problem and may even lead to amputation. The aim of the current study is to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in facilitating the healing of diabetic foot ulcers and reducing the number of amputations in these patients.Methods : The study will be conducted in the city of Imperatriz, Maranhão from 2019 to 2020, in diabetic patients with chronic foot ulcers (classified as Wagner grade 2, 3, and 4, persisting for more than one month). The outpatient follow-up for diabetic foot patients will be done at the SUS (Unified Health System), with a sample size of 120 patients (60 patients for each arm). Half of the patients will receive standard treatment, i.e. dressings, debridement, antibiotics, and load relief, along with HBOT (HBOT group), and the other half will receive only standard treatment (control group). The patients of the HBOT group will be evaluated upon admission, after 10, 20, 30 and 35 HBOT sessions, and after six months. The patients of the control group will also be evaluated at equivalent periods. The progression of the wounds and specific treatment, such as appropriate bandage, antibiotic therapy, or need of some surgical intervention will be evaluated on a weekly basis. The SF-36 quality of life questionnaire will be filled upon admission and after three months of follow-up in both groups. Upon admission, the patients of both groups will undergo arterial Doppler ultrasound, and laboratory tests–complete blood count, erythrocyte sedimentation rate, C-reactive protein, creatinine, fasting blood glucose, and glycosylated haemoglobin.Discussion : Diabetic foot ulcers are a highly prevalent complication of diabetes with serious consequences. A study to assess the efficacy of HBOT in healing the ulcers and reducing the rate of amputations in diabetic patients is justified, which will eventually aid in the development of guidelines for treating these ulcers.

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An Update on the Appropriate Role for Hyperbaric Oxygen: Indications and Evidence

Cited by 50 publications

References 43 publications

A new approach to clinical research: Integrating clinical care, quality reporting, and research using a wound care network‐based learning healthcare system

A new approach to clinical research: Integrating clinical care, quality reporting, and research using a wound care network‐based learning healthcare system

Harnessing electronic healthcare data for wound care research: Standards for reporting observational registry data obtained directly from electronic health records

Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol

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