Evaluating Elements of the Care Partner Experience in Individuals Who Care for People with Alzheimer's Disease Across the Severity Spectrum.

INTRODUCTION: Non-professional care partners play an important and often evolving role in the care of persons living with Alzheimer's disease (PLWAD). We investigated two elements of the care partner experience, namely time and strain incurred by care partners providing care to PLWAD across the severity spectrum. METHODS: Data gathered from the Alzheimer's Disease Patient and Caregiver Engagement (AD PACE) What Matters Most (WMM) study series were analyzed to determine how much time care partners spent providing care to PLWAD based on where the care recipients lived. Additionally, quantitative assessments of weekly hours providing care and the strain experienced by care partners were conducted using the UsAgainstAlzheimer's A-LIST Insights Series survey, which included the Modified Caregiver Strain Index (MCSI). Finally, a targeted literature review was conducted to contextualize findings and characterize the existing literature landscape. RESULTS: Care partners in the AD PACE WMM studies (n = 139) spent significantly more hours providing care for recipients who lived with someone (mean ± standard deviation [SD], 57.3 ± 44.3 h/week) than for recipients who lived alone (26.0 ± 12.0 h/week) (P = 0.0096) or lived in assisted living/nursing home (23.6 ± 14.4 h/week) (P = 0.0002). In the A-LIST Insights Series survey, care partners provided an overall mean (± SD) 58.1 ± 53.0 h of direct care each week, with caregiving hours increasing with increasing severity of AD/AD-related dementias (AD/ADRD). Additionally, care partners for recipients with mild (n = 14), moderate (n = 111), and severe AD/ADRD (n = 91) had overall mean MCSI scores of 9.0 ± 3.8 (range 2-14), 13.3 ± 4.8 (range 4-23), and 17.5 ± 5.3 (range 4-26), respectively, with higher scores suggesting greater care partner strain. CONCLUSIONS: Persons living with AD require increasing levels of care along the spectrum of disease, and even individuals with early disease need care from partners. Early interventions that slow progression of AD and programs that improve family function may have beneficial impact on the experiences of care partners for recipients with mild, moderate, or severe AD.

Parents' experiences of caring for a child with autism spectrum disorder in the United States: A systematic review and metasynthesis of qualitative evidence.

INTRODUCTION: A comprehensive review to identify key topics and to discern patterns in the perspectives of parents of children with autism spectrum disorder (ASD) can improve understanding of the knowledge flow among stakeholders, thereby guiding future educational strategies. This systematic review and metasynthesis characterized the experiences of parents who have a child with ASD using qualitative studies in the literature. METHOD: A predefined search strategy across five databases was conducted in accordance with PRISMA guidelines. A metaaggregative approach was used to synthesize extracted data into themes that were condensed into overarching categories. RESULTS: Ten themes and nine groups of key stakeholders were identified across 12 studies. Themes were grouped into four categories: behaviors, socioemotional impacts, structural needs, and gaps in knowledge about ASD. Gaps in knowledge about ASD was a pervasive theme that played a critical role in interactions between stakeholders. Families of children with ASD make life adaptations in a variety of areas, including structuring activities around ASD, physical modifications to homes for safety, intentional social isolation, increased financial expenses, and homeschooling. DISCUSSION: Parents must educate themselves on how to manage all aspects of ASD, and in doing so, often become experts not only in the individual needs of their own child and families, but in ASD more broadly. Family experiences contextualize key stakeholder knowledge for application across multiple systems, including education and health care services, home, and the community. Educational interventions that integrate family, service provider, and community perspectives are needed to address the stakeholder gap in knowledge. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Health economics for treatment of diabetic foot ulcers: a cost-effectiveness analysis of eight skin substitutes.

AIM: Skin substitutes are frequently used to treat chronic diabetic foot ulcers (DFU), and many different options are available. While the clinical efficacy of many products has been evaluated, a comprehensive cost-effectiveness analysis comparing the most popular skin substitutes and using the most recent cost data has been lacking. METHODS: This study compared eight skin substitutes using published efficacy rates combined with the Centers for Medicare and Medicaid Services (CMS) 2018 cost data. The study criteria resulted in the inclusion of seven studies that described efficacy rates for treatment of DFUs using the skin substitutes. RESULTS: The results revealed wide discrepancies between these skin substitutes for the costs of treatments and healing rates in hospital outpatient departments and physician office settings. Healing rates for 12 and 16 weeks ranged from 28% to 68%, while the average cost for treating one DFU varied from $2001 to $14,507 and $1207 to $8791 in the hospital outpatient department and physician's office setting, respectively. The estimated patient share of costs for treating a single DFU ranged from $400 to $2901 and $241 to $1758 in the hospital outpatient department and physician's office setting, respectively. Most importantly, the estimated number of wounds healed out of 100 DFUs per $1000 expenditure with each patient ranged from 3.9-26.5 DFUs in the hospital outpatient department, and 4.3-36.4 DFUs in the physicians' office setting. CONCLUSIONS: This study revealed that the costs of a skin substitute itself did not necessarily correlate with its healing efficacy. These results provide a comprehensive cost-effectiveness analysis to enable integrated health-care systems, health professionals and reimbursement payers to make informed value decisions when treating DFUs.

A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix.

OBJECTIVE: This prospective, multicenter study evaluated the efficacy and safety of an acellular dermal matrix allograft, DermACELL (D-ADM; LifeNet Health, Virginia Beach, Virginia), in the treatment of large, complex diabetic foot ulcers (DFUs) that probed to tendon or bone. METHODS: Inclusion criteria were Wagner grade 3 or 4 DFUs between 4 weeks and 1 year in duration. All participants received one application of D-ADM at baseline and could receive one additional application if wound healing arrested. Ulcers were assessed weekly for 16 weeks using a laser measuring device. RESULTS: Sixty-one participants were enrolled, with an average wound area of 29.0 cm; 59 of these ulcers showed exposed bone. The entire per-protocol population (n = 47) achieved 100% granulation. The mean time to 100% granulation was 4.0 weeks with an average of 1.2 applications of D-ADM. Mean percent wound area reduction was 80.3% at 16 weeks. Those DFUs 15 cm or smaller were substantially more likely to close than DFUs larger than 29 cm (P = .0008) over a 16-week duration. No complications were associated with the use of the studied matrix. CONCLUSIONS: The D-ADM demonstrated the ability to rapidly reduce the size of large, complex DFUs with exposed bone. Some wounds did not completely heal by 16 weeks; however, the significant reduction in size suggests that these large, complex wounds may heal if given more time.

Preservation of allograft bone using a glycerol solution: a compilation of original preclinical research.

BACKGROUND: Bone allografts are used in many orthopedic procedures to provide structural stability as well as an osteoconductive matrix for bone ingrowth and fusion. Traditionally, bone allografts have been preserved by either freezing or freeze-drying. Each of these preservation methods has some disadvantages: Frozen grafts require special shipping and storage conditions, and freeze-drying requires special lyophilization equipment and procedures that may impact biomechanical integrity. This report describes an alternate type of preservation using glycerol, which allows storage of fully-hydrated tissues at ambient temperature avoiding the potential complications from freeze-drying. METHODS: In the in vitro three-point bend test, cortical bone was processed and frozen, freeze-dried, or treated with glycerol-based preservation (GBP). Load was applied to each graft at a rate of 2.71 mm/min. The flexural strain, flexural strength, and flexural modulus were then calculated. In the in vitro axial compression test, iliac crest wedges, fibular segments, and Cloward dowels were processed and either freeze-dried or GBP treated. The compressive strength of the grafts were tested at time zero and after real time aging of 1, 4, and 5 years. In the in vivo rat calvarial defect assessment, freeze-dried, frozen, and GBP bone implants were compared after being implanted into a critical sized defect. Samples underwent histological and biomechanical evaluation. RESULTS: Bone grafts subjected to GBP were found to be at least biomechanically equivalent to frozen bone while also being significantly less brittle than freeze-dried bone. GBP-preserved bone demonstrated significantly greater compressive strength than freeze-dried at multiple time points. Preclinical research performed in calvaric defect models found that GBP-preserved bone had similar osteoconductivity and biocompatibility to frozen and freeze-dried samples. CONCLUSION: Preclinical research demonstrated that glycerol-preservation of bone yields a material that maintains biomechanical strength while eliminating the need for extensive rehydration or thaw periods if used clinically. Additionally, in vivo evidence suggests no negative impact of glycerol-preservation on the ability of bone grafts to successfully participate in new bone formation and fusion.

Achilles Tendon Augmented Repair Using Human Acellular Dermal Matrix: A Case Series.

Achilles tendon ruptures are common in the general population, especially among members of the older demographic occasionally active in sports. Operative treatments provide a lower incidence of rerupture than do nonoperative treatments, although surgical complications remain a concern. The use of a human acellular dermal matrix to augment Achilles tendon repair might reduce the incidence of complications. In the present case series, we describe the outcomes of 9 patients who underwent Achilles tendon repair with acellular dermal matrix augmentation. Functional outcomes were evaluated using the Foot Function Index-Revised long form, and the clinical results were recorded. After a mean average follow-up period of 14.4 (range 12.0 to 20.0) months, the mean Foot Function Index-Revised long form score was 33.0% ± 4.2%. No cases of rerupture or complications that required additional treatment occurred during the observation period. The outcomes we have presented support further evaluation beyond this case series for using a human acellular dermal matrix to augment Achilles tendon repairs.

A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator.

This study compared the efficacy and safety of a human acellular dermal matrix (ADM), D-ADM, with a conventional care arm and an active comparator human ADM arm, GJ-ADM, for the treatment of chronic diabetic foot ulcers. The study design was a prospective, randomized controlled trial that enrolled 168 diabetic foot ulcer subjects in 13 centers across 9 states. Subjects in the ADM arms received one application but could receive one additional application of ADM if deemed necessary. Screen failures and early withdrawals left 53 subjects in the D-ADM arm, 56 in the conventional care arm, and 23 in the GJ-ADM arm (2:2:1 ratio). Subjects were followed through 24 weeks with major endpoints at Weeks 12, 16, and 24. Single application D-ADM subjects showed significantly greater wound closure rates than conventional care at all three endpoints while all applications D-ADM displayed a significantly higher healing rate than conventional care at Week 16 and Week 24. GJ-ADM did not show a significantly greater healing rate over conventional care at any of these time points. A blinded, third party adjudicator analyzed healing at Week 12 and expressed "strong" agreement (κ = 0.837). Closed ulcers in the single application D-ADM arm remained healed at a significantly greater rate than the conventional care arm at 4 weeks posttermination (100% vs. 86.7%; p = 0.0435). There was no significant difference between GJ-ADM and conventional care for healed wounds remaining closed. Single application D-ADM demonstrated significantly greater average percent wound area reduction than conventional care for Weeks 2-24 while single application GJ-ADM showed significantly greater wound area reduction over conventional care for Weeks 4-6, 9, and 11-12. D-ADM demonstrated significantly greater wound healing, larger wound area reduction, and a better capability of keeping healed wounds closed than conventional care in the treatment of chronic DFUs.

Biological incorporation of human acellular dermal matrix used in Achilles tendon repair.

Human acellular dermal matrices (ADMs) are used successfully in a variety of procedures, including sports medicine related, wound repair, and breast reconstructions, but the mechanism of repair is still not fully understood. An opportunity to explore this mechanism presented itself when a patient experienced a rerupture of the native tendon due to a fall that occurred 2 months after undergoing an Achilles tendon repair using Matracell treated ADM. The ADM was removed and an extensive histology analysis was performed on the tissue. Additionally, a literature review was conducted to determine the mechanism of ADM integration into the tendon structure and explore if differences in this mechanism exist for different types of human ADMS. The histology analysis demonstrated that the healing process during a tendon reconstruction procedure is similar to that of wound healing. Furthermore, the literature review showed that differences exist in the mechanism for integration among various human ADMs and that these differences may be due to variances in the methods and technologies that manufactures use to process human ADMs.

Evaluation of glycerol-preserved bone allografts in cervical spine fusion: a prospective, randomized controlled trial.

OBJECT: Bone allografts used for interbody spinal fusion are often preserved through either freeze drying or lowtemperature freezing, each having disadvantages related to graft preparation time and material properties. In response, a glycerol preservation treatment has been developed to maintain the biomechanical properties of allografts at ambient temperatures, requiring no thawing or rehydration and minimal rinsing prior to implantation. The authors conducted a prospective randomized study to compare the clinical results of glycerol-preserved Cloward dowels and those of freezedried Cloward dowels in anterior cervical discectomy and fusion. The primary outcome measures were evidence of fusion and graft subsidence, and the secondary outcome measures included adverse events, pain, and neck disability scores. METHODS: Of 106 patients, 53 (113 levels of surgery) were randomly assigned to the glycerol-preserved graft group and 53 (114 levels of surgery) to the freeze-dried graft group. Subsidence was assessed at 3 and 6 months after implantation. Evidence of fusion was evaluated radiographically at 6 months postimplantation. Subsidence was quantitatively assessed based on physical measurements obtained from radiographs by using calibrated comparators, whereas fusion was also evaluated visually. Surgeons were blinded to treatment type during visual and physical assessments of the patients and the radiographs. RESULTS: No one in either group had evidence of complete nonunion according to radiographic evaluation at the 6-month follow-up. Average subsidence for all graft-treated levels was 2.11 mm for the glycerol-preserved group and 2.73 mm for the freeze-dried group at the 3-month follow-up and 2.13 and 2.83 mm at the 6-month follow-up, respectively. The 2 treatment groups were statistically equivalent (p = 0.2127 and 0.1705 for the 3- and 6-month follow-up, respectively). No differences were noted between the graft types in terms of adverse event incidence or severity. CONCLUSIONS: Glycerol-preserved bone allografts exhibit fusion results and subsidence values similar to those of their freeze-dried counterparts, potentially more favorable biomechanical properties, and significantly shorter preparation times.

Decellularization of human dermis using non-denaturing anionic detergent and endonuclease: a review.

Decellularized human dermis has been used for a number of clinical applications including wound healing, soft tissue reconstruction, and sports medicine procedures. A variety of methods exist to prepare this useful class of biomaterial. Here, we describe a decellularization technology (MatrACELL(®)) utilizing a non-denaturing anionic detergent, N-Lauroyl sarcosinate, and endonuclease, which was developed to remove potentially immunogenic material while retaining biomechanical properties. Effective decellularization was demonstrated by a residual DNA content of ≤4 ng/mg of wet weight which represented >97 % DNA removal compared to unprocessed dermis. Two millimeter thick MatrACELL processed human acellular dermal matrix (MH-ADM) exhibited average ultimate tensile load to failure of 635.4 ± 199.9 N and average suture retention strength of 134.9 ± 55.1 N. Using an in vivo mouse skin excisional model, MH-ADM was shown to be biocompatible and capable of supporting cellular and vascular in-growth. Finally, clinical studies of MH-ADM in variety of applications suggest it can be an appropriate scaffold for wound healing, soft tissue reconstruction, and soft tissue augmentation.

Use of controlled low dose gamma irradiation to sterilize allograft tendons for ACL reconstruction: biomechanical and clinical perspective.

As reviewed here, numerous biomechanical and clinical studies support the use of controlled, low temperature irradiation of allograft tendons, to provide both excellent clinical results and medical-device grade sterile allografts with minimal risk of disease transmission.