Development and Validation of the Protocol for Administering Telehealth Home (PATH) Assessments.

Home safety assessments and subsequent modifications can prevent hospitalization, institutionalization, and death among older adults. Telehealth has been shown to be an effective means to administer home safety assessments. However, a structured approach to synchronous telehealth home assessments has not been examined. This study involved development and validation of a structured telehealth home assessment protocol. The Protocol for Administering Telehealth Home (PATH) assessment was developed based on literature review, clinical experience with in-person and telehealth home assessments, and interviews with content experts. Six older adults participated in the validation phase of the protocol using a quasi-experimental, mixed-methods, one-group research design. The validation process resulted in modifications to the protocol to enhance its utility in practice. The PATH protocol provides a valid, structured approach to conducting synchronous telehealth home assessments and can be used by occupational therapists to administer home assessments for older adults desiring to age in place.

Successful desensitization to brentuximab vedotin after hypersensitivity reaction.

Monoclonal antibodies (mAb) have become the standard of care for numerous diseases. However, side effects including infusion and hypersensitivity reactions experienced by patients continue to be a limiting factor in their use. In the therapy of cancer, treatment choices are frequently limited and minimizing side effects of a life-saving or life-prolonging therapy becomes of the utmost importance. We report the successful use of a rapid desensitization protocol in a patient with NHL, treated with a novel antibody-drug conjugate, chimeric monoclonal antibody linked to the antimitotic agent monomethyl auristatin E (MMAE) Brentuximab vedotin, who had previously developed a hypersensitivity reaction.

Preemptive leucovorin administration minimizes pralatrexate toxicity without sacrificing efficacy.

Balancing efficacy and safety of drugs is key for successful cancer therapy, as adverse reactions can prohibit the use of efficacious treatments. Pralatrexate (PDX) is a novel antifolate with a higher affinity for tumor cells than methotrexate, Food and Drug Administration (FDA) approved for use in relapsed and refractory peripheral T-cell lymphoma (PTCL) and transformed mycosis fungoides (T-MF). Patients with T-MF have a higher incidence of adverse events than patients with other lymphomas, necessitating a lower recommended dose of 15 mg/m(2) (vs. 30 mg/m(2) for PTCL). Dose-limiting toxicity (DLT) mucositis occurs in about 25% of patients with T-MF, but milder mucositis is observed in almost all patients with T-MF, frequently leading to therapy discontinuation despite clinical response. Leucovorin rescue is the standard of care for high-dose methotrexate therapy, but has not been studied or recommended for use with PDX. We report our clinical experience using leucovorin with PDX (30 mg/m(2)) with good clinical response and no DLTs. Prophylactic leucovorin deserves further investigation in prospective clinical trials to allow patients with cutaneous lymphomas to receive the full benefit of PDX therapy without intolerable toxicity.

Breast implant-associated ALCL: a unique entity in the spectrum of CD30+ lymphoproliferative disorders.

CD30(+) lymphoproliferative disorders represent a spectrum of diseases with distinct clinical phenotypes ranging from reactive conditions to aggressive systemic anaplastic lymphoma kinase (ALK)(-) anaplastic large cell lymphoma (ALCL). In January 2011, the U.S. Food and Drug Administration (FDA) announced a possible association between breast implants and ALCL, which was likened to systemic ALCL and treated accordingly. We analyzed existing data to see if implant-associated ALCL (iALCL) may represent a distinct entity, different from aggressive ALCL. We conducted a systematic review of publications regarding ALCL and breast implantation for 1990-2012 and contacted corresponding authors to obtain long-term follow-up where available. We identified 44 unique cases of iALCL, the majority of which were associated with seroma, had an ALK(-) phenotype (97%), and had a good prognosis, different from the expected 40% 5-year survival rate of patients with ALK(-) nodal ALCL (one case remitted spontaneously following implant removal; only two deaths have been reported to the FDA or in the scientific literature since 1990). The majority of these patients received cyclophosphamide, doxorubicin, vincristine, and prednisolone with or without radiation, but radiation alone also resulted in complete clinical responses. It appears that iALCL demonstrates a strong association with breast implants, a waxing and waning course, and an overall good prognosis, with morphology, cytokine profile, and biological behavior similar to those of primary cutaneous ALCL. Taken together, these data are suggestive that iALCL may start as a reactive process with the potential to progress and acquire an aggressive phenotype typical of its systemic counterpart. A larger analysis and prospective evaluation and follow-up of iALCL patients are necessary to definitively resolve the issue of the natural course of the disease and best therapeutic approaches for these patients.

Can harmonic focus curved shear effectively seal the pancreatic ducts and prevent pancreatic leak? Feasibility evaluation and testing in ex vivo and in vivo porcine models.

BACKGROUND: The purpose of this study was to evaluate the ability of Harmonic energy technology to transect and seal the pancreatic duct compared with the standard monopolar electrosurgery transection and oversew technique in a porcine distal pancreatectomy survival model. Harmonic energy technology is as effective as standard oversew technique for preventing pancreatic leak after distal pancreatectomy. METHODS: The animal protocol used for this study was approved by the Institutional Animal Care and Use Committee (IACUC) prior to the conduct of the study. Spleen-preserving distal pancreatectomy was performed in seven pigs (80-100 lb) by the same surgeon. In four animals, the pancreas was divided with the Harmonic Focus Curved Shears (test group) with no additional suturing for control of hemostasis or leak. In three animals, the pancreas was divided using monopolar electrosurgery (30 W coagulation) and the cut end of the pancreas was oversewn with a locking suture (control group). A previously worked out standard operative technique was used in all procedures. Operating end points included surgery time and blood loss. Animals were euthanized and necropsied at 7 to 8 d following surgery. Survival endpoints included clinical response to surgery, serum chemistry profiles before surgery and at necropsy, and histology of the pancreas transection site. RESULTS: Mean operative time for pancreatic resection was 15min in the control group and 10min in the test group. No significant blood loss was noted in either group. The median size of the resected pancreas was 4.3 cm. Three animals in the control group and three in the test group completed the study without complications. One animal in the test group failed to eat, appeared dehydrated, and was taken off study on POD#2. In this animal, there was a doubling of serum lipase at euthanasia and gross evidence of ileus, which was attributed to a pancreatic leak. Histologic examination of the residual pancreas in both groups at necropsy revealed a 2-5 mm band of necrotic tissue associated with neutrophilic infiltration in the control group, and less than a 1mm band of necrotic tissue in the test group. CONCLUSION: The Harmonic Focus Curved Shears, using Harmonic energy technology, appears to seal the pancreatic ducts and prevent pancreatic leak at 75% (3/4) efficiency in this survival model. However, the survival leak rate, 25% (1/4) was higher in the Harmonic Focus Curved Shears test group compared with the control oversewn group 0% (0/3). This feasibility study shows potential for Harmonic technology to be used to seal the pancreatic ducts, but additional testing and optimization of surgical techniques are needed.

A comprehensive review of evidence-based strategies to prevent and treat postoperative ileus.

BACKGROUND: Postoperative ileus (POI) is a common complication of abdominal and several other surgeries leading to increased hospital stay and healthcare costs. POI also contributes towards numerous postsurgical comorbidities including deep vein thrombosis and pneumonia. POI is characterized by bowel distention and lack of bowel sounds, flatus and bowel movements. The causative mechanism is not fully understood and may be multifactorial including disorganized electrical activity, activation of inflammatory mediators and the use of opioid analgesics. METHODS: A selective review of the literature pertaining to the prevention and treatment of adynamic ileus and POI was completed. More specifically we sought to evaluate RCTs, meta-analyses, consensus statements and articles providing graded evidence-based data on POI prevention and treatment. RESULTS: Perioperative strategies employed to prevent or limit the duration of POI include avoidance of preoperative fasting and mechanical bowel preparation, use of epidural-local anesthetics, implementation of minimally-invasive surgical techniques, and modification of pain management strategies to limit opioid administration among others. CONCLUSION: Though many of these strategies have proven beneficial, no single approach has demonstrated the ability to prevent or treat POI. However, when these strategies are used in combination as part of a fast-track multimodal treatment plan, there is a significant decrease in time to return of normal bowel function and a shortened hospital stay. Additional studies are needed to make specific recommendations regarding which components of fast-track protocols are most beneficial.