The Hyperbaric Oxygen Therapy Registry: Driving quality and demonstrating compliance.

OBJECTIVE: To provide an update on the status of provider participation in the US Wound Registry (USWR) and its specialty registry the Hyperbaric Oxygen Therapy Registry (HBOTR), which provide much-needed national benchmarking and quality measurement services for hyperbaric medicine. METHODS: Providers can meet many requirements of the Merit-Based Incentive Payment System (MIPS) and simultaneously participate in the HBOTR by transmitting Continuity of Care Documents (CCDs) directly from their certified electronic health record (EHR) or by reporting hyperbaric quality measures, the specifications for which are available free of charge for download from the registry website as electronic clinical quality measures for installation into any certified EHR. Computerized systems parse the structured data transmitted to the USWR. Patients undergoing hyperbaric oxygen (HBO2) therapy are allocated to the HBOTR and stored in that specialty registry database. The data can be queried for benchmarking, quality reporting, public policy, or specialized data projects. RESULTS: Since January 2012, 917,758 clinic visits have captured the data of 199,158 patients in the USWR, 3,697 of whom underwent HBO2 therapy. Among 27,404 patients with 62,843 diabetic foot ulcers (DFUs) captured, 9,908 DFUs (15.7%) were treated with HBO2 therapy. Between January 2016 and September 2018, the benchmark rate for the 1,000 DFUs treated with HBO2 was 7.3%, with an average of 28 treatments per patient. There are 2,100 providers who report data to the USWR by transmitting CCDs from their EHR and 688 who submit quality measure data, 300 (43.6%) of whom transmit HBO2 quality data.

Comparative Effectiveness of Clostridial Collagenase Ointment to Medicinal Honey for Treatment of Pressure Ulcers.

Objective: Compare enzymatic debridement using clostridial collagenase ointment (CCO) with autolytic debridement using medicinal honey in the hospital outpatient setting for treating pressure ulcers (PUs). Approach: Retrospective deidentified electronic health records from 2007-2013 were extracted from the U.S. Wound Registry. Propensity score matching followed by multivariable analyses was used to adjust for selection bias and assess treatment effects comparing CCO-treated versus honey-treated PUs. Key outcomes included 100% granulation and epithelialization at 1 year. Results: Five hundred seventeen CCO-treated PUs (446 patients) were matched to corresponding honey-treated PUs (341 patients). The majority of PUs were stage III (CCO 56%, honey 55%). CCO users had significantly fewer total visits (9.1 vs. 12.6; p < 0.001), fewer total selective sharp debridements (2.7 vs. 4.4; p < 0.001), and fewer PUs receiving negative pressure wound therapy (29% vs. 38%; p = 0.002) compared with honey. Innovation: CCO-treated PUs were 38% more likely to achieve 100% granulation compared to honey-treated PUs at 1 year, p = 0.018. Mean days to 100% granulation were significantly lower for CCO-treated PUs (255 vs. 282 days, p < 0.001). CCO-treated PUs were 47% (p = 0.024) more likely to epithelialize at 1 year compared to PUs treated with honey. Mean days to epithelialization were significantly lower for PUs treated with CCO at 1 year (288 vs. 308 days; p = 0.011). Conclusion: All stages of PUs treated with CCO achieved faster rates of granulation and subsequent epithelialization compared to PUs treated with medicinal honey as measured by real-world data collected in the hospital outpatient department care setting.

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

BACKGROUND: Among advanced therapeutic interventions for wounds, hyperbaric oxygen therapy (HBOT) has the unique ability to ameliorate tissue hypoxia, reduce pathologic inflammation, and mitigate ischemia reperfusion injury. Most of the conditions for which it is utilized have few successful alternative treatments, and the morbidity and mortality associated with treatment failure are significant. Data on the efficacy and effectiveness of HBOT were reviewed, comparative effectiveness research of HBOT was explained, and a new paradigm for the appropriate use of HBOT was described. METHODS: Systematic reviews and randomized controlled trials that have evaluated HBOT were reviewed. RESULTS: Although numerous small randomized controlled trials provide compelling support for HBOT, the physics of the hyperbaric environment create significant barriers to trial design. The electronic health record infrastructure created to satisfy mandatory quality and registry reporting requirements as part of healthcare reform can be harnessed to facilitate the acquisition of real world data for HBOT comparative effectiveness studies and clinical decision support. CONCLUSIONS: Predictive models can identify patients unlikely to heal spontaneously and most likely to benefit from HBOT. Although electronic health records can automate the calculation of predictive models making them available at the point of care, using them in clinical decision making is complicated. It is not clear whether stakeholders will support the allocation of healthcare resources using mathematical models, but the current patient selection process mandates a 30-day delay for all patients who might benefit and allows treatment for at least some patients who cannot benefit.

Rapid analysis of hyperbaric oxygen therapy registry data for reimbursement purposes: Technical communication.

OBJECTIVE: To explain how Hyperbaric Oxygen Therapy Registry (HBOTR) data of the US Wound Registry (USWR) helped establish a fair analysis of the physician work of hyperbaric chamber supervision for reimbursement purposes. METHODS: We queried HBOTR data from January 1, 2013, to December 31, 2013, on patient comorbidities and medications as well as the number of hyperbaric oxygen (HBO2) therapy treatments supervised per physician per day from all hyperbaric facilities participating in the USWR that had been using the electronic medical record (EHR) for more than six months and had passed data completeness checks. RESULTS: Among 11,240 patients at the 87 facilities included, the mean number of comorbidities and medications was 10 and 12, respectively. The mean number of HBO2 treatments supervised per physician per day was 3.7 at monoplace facilities and 5.4 at multiplace facilities. Following analysis of these data by the RUC, the reimbursement rate of chamber supervision was decreased to $112.06. CONCLUSIONS: Patients undergoing HBO2 therapy generally suffer from multiple, serious comorbidities and require multiple medications, which increase the risk of HBO2 and necessitate the presence of a properly trained hyperbaric physician. The lack of engagement by hyperbaric physicians in registry reporting may result in lack of adequate data being available to counter future challenges to reimbursement.

A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home.

PURPOSE: Pneumatic compression devices (PCDs) are used in the home setting as adjunctive treatment for lymphedema after acute treatment in a clinical setting. PCDs range in complexity from simple to technologically advanced. The objective of this prospective, randomized study was to determine whether an advanced PCD (APCD) provides better outcomes as measured by arm edema and tissue water reductions compared to a standard PCD (SPCD) in patients with arm lymphedema after breast cancer treatment. METHODS: Subjects were randomized to an APCD (Flexitouch system, HCPCS E0652) or SPCD (Bio Compression 2004, HCPCS E0651) used for home treatment 1 h/day for 12 weeks. Pressure settings were 30 mmHg for the SPCD and upper extremity treatment program (UE01) with standard pressure for the APCD. Thirty-six subjects (18 per group) with unilateral upper extremity lymphedema with at least 5% arm edema volume at the time of enrollment, completed treatments over the 12-week period. Arm volumes were determined from arm girth measurements and suitable model calculations, and tissue water was determined based on measurements of the arm tissue dielectric constant (TDC). RESULTS: The APCD-treated group experienced an average of 29% reduction in edema compared to a 16% increase in the SPCD group. Mean changes in TDC values were a 5.8% reduction for the APCD group and a 1.9% increase for the SPCD group. CONCLUSION: This study suggests that for the home maintenance phase of treatment of arm lymphedema secondary to breast cancer therapy, the adjuvant treatment with an APCD provides better outcomes than with a SPCD.

Assessment of lymphatic contractile function after manual lymphatic drainage using near-infrared fluorescence imaging.

OBJECTIVE: To investigate the feasibility of assessing the efficacy of manual lymphatic drainage (MLD), a method for lymphedema (LE) management, by using near-infrared (NIR) fluorescence imaging. DESIGN: Exploratory pilot study. SETTING: Primary care unit. PARTICIPANTS: Subjects (N=10; age, 18-68y) with a diagnosis of grade I or II LE and 12 healthy control subjects (age, 22-59y). INTERVENTION: Indocyanine green (25 µg in 0.1 mL each) was injected intradermally in bilateral arms or legs of subjects. Diffused excitation light illuminated the limbs, and NIR fluorescence images were collected by using custom-built imaging systems. Subjects received MLD therapy, and imaging was performed pre- and posttherapy. MAIN OUTCOME MEASURES: Apparent lymph velocities and periods between lymphatic propulsion events were computed from fluorescence images. Data collected pre- and post-MLD were compared and evaluated for differences. RESULTS: By comparing pre-MLD lymphatic contractile function against post-MLD lymphatic function, results showed that average apparent lymph velocity increased in both the symptomatic (+23%) and asymptomatic (+25%) limbs of subjects with LE and control limbs (+28%) of healthy subjects. The average lymphatic propulsion period decreased in symptomatic (-9%) and asymptomatic (-20%) limbs of subjects with LE, as well as in control limbs (-23%). CONCLUSIONS: We showed that NIR fluorescence imaging could be used to quantify immediate improvement of lymphatic contractile function after MLD.

A patient-centered approach to treatment of morbid obesity and lower extremity complications: an overview and case studies.

The prevalence of morbid obesity, along with related comorbidities, is dramatically increasing in the US, confounding wound care for persons at heightened risk for skin compromise. The purpose of this overview is to examine common concerns related to morbid obesity and interrelated lower extremity complications, including wound and skin infections, dermatologic conditions, lymphovenous obstruction syndromes, chronic venous insufficiency, and anatomical abnormalities such as massive localized lymphedema. Treatment may include surgery for massive lymphedema localizations, compression bandaging for chronic venous insufficiency as well as lymphedema, manual lymph drainage for lymphedema, and prompt and aggressive management of wound infection and bioburden. Case studies are presented to illustrate some lower extremity complications of morbid obesity and appropriate protocols of care. Although increasing evidence suggests that morbidly obese patients are predisposed to secondary lymphedema and that primary lymphedema can cause adult-onset obesity, the mechanisms by which these events occur remain unclear. However, unless the underlying problem of morbid obesity is addressed, the problems for which these patients seek care will continue to recur.

Factors influencing the outcome of lower-extremity diabetic ulcers treated with hyperbaric oxygen therapy.

The objectives of this study were to report outcomes of a large number of patients receiving hyperbaric oxygen therapy (HBO(2)T) for diabetic lower-extremity ulcers, and to identify likely outcome predictors. Five hyperbaric facilities supplied data on 1,006 patients. A sixth clinic served as a validation sample for the regression-based prediction model, and later additional data from Memorial Hermann Hospital were added. The severity of lower-extremity lesions was assessed upon initiation of HBO(2)T using the Modified Wagner scale, and the outcome described as healed, partially healed, not improved, amputated, or died. Overall, 73.8% of patients improved (granulated or healed). Factors significantly related to outcome included renal failure, pack-year smoking history, transcutaneous oximetry, number of HBO(2)T treatments, and interruption of treatment regimen. Number of treatments per week and treatment pressure (2.0 vs. 2.4 atmospheres absolute) were not significant factors in outcome. Concomitant administration of autologous growth factor gel did not improve outcome. A multiple regression model was fitted to the data that can be used to predict the outcome of diabetic patients undergoing HBO(2)T. Given the high cost of amputation and rehabilitation, these data suggest that hyperbaric oxygen treatment should be an important adjunctive therapy to heal lower-extremity lesions, especially those with a Wagner grade of 3 or higher.

The predictive value of transcutaneous oxygen tension measurement in diabetic lower extremity ulcers treated with hyperbaric oxygen therapy: a retrospective analysis of 1,144 patients.

The objective of this retrospective analysis was to determine the reliability of transcutaneous oxygen tension measurement (TcPO2) in predicting outcomes of diabetics who underwent hyperbaric oxygen therapy for lower extremity wounds. Six hyperbaric facilities provided TcPO2 data under several possible conditions: breathing air, breathing oxygen at sea level, and breathing oxygen in the chamber. Overall, 75.6% of the patients improved after hyperbaric oxygen therapy. Baseline sea-level air TcPO2 identified the degree of tissue hypoxia but had little statistical relationship with outcome prediction because some patients healed after hyperbaric oxygen therapy despite very low prehyperbaric TcPO2 values. Breathing oxygen at sea level was unreliable for predicting failure, but 68% reliable for predicting success after hyperbaric oxygen therapy. TcPO2 measured in chamber provides the best single discriminator between success and failure of hyperbaric oxygen therapy using a cutoff score of 200 mmHg. The reliability of in-chamber TcPO2 as an isolated measure was 74% with a positive predictive value of 58%. Better results can be obtained by combining information about sea-level air and in-chamber oxygen. A sea-level air TcPO2 < 15 mmHg combined with an in-chamber TcPO2 < 400 mmHg predicts failure of hyperbaric oxygen therapy with a reliability of 75.8% and a positive predictive value of 73.3%.