BACKGROUND: The modified frailty index 5 (mFI-5)-a scale based on the five variables diabetes, hypertension, chronic obstructive pulmonary disease, congestive heart failure, and functional dependency-has been shown to be a valid predictor of surgical outcomes. In this study we sought to evaluate the ability of the mFI-5 to predict the postoperative outcomes of head and neck microvascular reconstruction. METHODS: Review of the 2015-2019 American College of Surgeons, National Surgical Quality Improvement Program (ACS NSQIP) database identified 5323 cases of microvascular reconstruction, of which 3795 were head and neck cases that provided parameters necessary to calculate the mFI-5. The groups were compared in terms of demographics and comorbidities. Post-operative outcomes assessed included mortality, average operative time and length of hospital stay, surgical and medical complications, and non-home discharge. RESULTS: Increases in the mFI were associated with longer hospitalization periods (10.5 ± 7.5 days in mFI 0 vs 14.9 ± 15.4 in mFI ≥ 3; p < 0.0001) higher rates of mortality (1% in mFI 0 vs 3.1% in mFI ≥ 3; p = 0.02), reoperation (15.4% in mFI 0 vs 17.2% in mFI ≥ 3; p = 0.002) and unplanned readmission (7.6% in mFI 0 vs 18.8% in mFI ≥ 3; p = 0.001). Rates of any complications (p < 0.0001), as well as surgical (p < 0.002) and medical (p < 0.0001) complications specifically were higher with greater mFI scores. Higher mFI scores also predicted decreased home discharge (p < 0.0001). Differences remained significant on multivariate analysis and subgroup analysis by age. CONCLUSION: The mFI-5 is a significant predictor of risk in microvascular head and neck reconstruction. Subgroup analysis by age highlights that the tool can help identify younger patients who are frail and hence at risk. Through appropriate pre-operative identification of frail patients surgeons can prospectively modify their operative and discharge planning as well as post-operative support.
- Publikační typ
- časopisecké články MeSH
PURPOSE: This large dose-ranging study explored the benefits of different combinations of mirabegron and solifenacin on health-related quality of life (HRQoL), based on patient-reported outcomes (PROs), and patients ('responders') achieving clinically meaningful improvements in efficacy and HRQoL. METHODS: SYMPHONY (NCT01340027) was a Phase II, placebo- and monotherapy-controlled, dose-ranging, 12-week trial. Adult patients with overactive bladder (OAB) for ≥3 months were randomized to 1 of 12 groups: 6 combination (solifenacin 2.5/5/10 mg + mirabegron 25/50 mg), 5 monotherapy (solifenacin 2.5/5/10 mg, or mirabegron 25/50 mg), or placebo. Change from baseline to end of treatment was assessed, versus placebo and solifenacin 5 mg in: PROs (OAB-q [Symptom Bother/total HRQoL] and Patient Perception of Bladder Condition score), and responders achieving minimally important differences (MIDs) in PROs and predetermined clinically meaningful improvements in efficacy (e.g. <8 micturitions/24 h). Changes in PROs and responders were analysed using an ANCOVA model and logistic regression, respectively. RESULTS: The Full Analysis Set included 1278 patients. Combination therapy of solifenacin 5/10 mg + mirabegron 25/50 mg significantly improved PROs versus solifenacin 5 mg and placebo, and significantly more responders achieved MIDs in PROs and efficacy. Micturition frequency normalization was approximately twofold greater with 10 + 25 mg (OR 2.06 [95 % CI 1.11, 3.84; p = 0.023]) and 5 + 50 mg (OR 1.91 [95 % CI 1.14, 3.21; p = 0.015]) versus solifenacin 5 mg. CONCLUSION: Combining mirabegron 25/50 mg and solifenacin 5/10 mg improves objective and subjective efficacy outcomes compared with placebo or solifenacin 5 mg.
- MeSH
- acetanilidy aplikace a dávkování MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- hodnocení výsledků péče pacientem MeSH
- hyperaktivní močový měchýř farmakoterapie MeSH
- kombinovaná farmakoterapie MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- minimální klinicky významný rozdíl MeSH
- senioři MeSH
- solifenacin sukcinát aplikace a dávkování MeSH
- thiazoly aplikace a dávkování MeSH
- urologické látky aplikace a dávkování MeSH
- výsledek terapie MeSH
- zdravotní stav MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- randomizované kontrolované studie MeSH
BACKROUND: Deep skin burn injuries, especially those on the face, hands, feet, genitalia and perineum represent significant therapeutic challenges. Autologous dermo-epidermal skin grafts (DESG) have become standard of care for treating deep burns. Additionally, human autologous thrombin activated autologous platelet concentrate (APC) has gained acceptance in the setting of wounds. While each of these interventions has been independently shown to accelerate healing, the combination of the two has never been evaluated. We hypothesized that the addition of platelets (source of growth factors and inhibitors necessary for tissue repair) to the DESG (source of progenitor cells and of tissue proteases necessary for spatial and temporal control of growth regulators released from platelets) would create the optimal environment for the reciprocal interaction of cells within the healing tissues. METHODS: We used clinical examination (digital photography), standardised scales for evaluating pain and scarring, in combination with blood perfusion (laser Doppler imaging), as well as molecular and laboratory analyses. RESULTS: We show for the first time that the combination of APC and DESG leads to earlier relief of pain, and decreased use of analgesics, antipruritics and orthotic devices. Most importantly, this treatment is associated with earlier discharges from hospital and significant cost savings. CONCLUSIONS: Our findings indicate that DESG engraftment is facilitated by the local addition of platelets and by systemic thrombocytosis. This local interaction leads to the physiological revascularization at 1-3 months. We observed significant elevation of circulating platelets in early stages of engraftment (1-7 days), which normalized over the subsequent 7 and 90 days.
- MeSH
- bolest farmakoterapie etiologie MeSH
- hojení ran MeSH
- jizva prevence a kontrola chirurgie MeSH
- laser doppler flowmetrie MeSH
- lidé středního věku MeSH
- lidé MeSH
- měření bolesti MeSH
- plazma bohatá na destičky * MeSH
- popálení chirurgie terapie ultrasonografie MeSH
- pruritus farmakoterapie etiologie MeSH
- reoperace MeSH
- transplantace kůže škodlivé účinky metody MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- práce podpořená grantem MeSH
- Research Support, N.I.H., Extramural MeSH
- Research Support, U.S. Gov't, Non-P.H.S. MeSH