New thin-film adhesive for sealing full-thickness corneal incisions in rabbits.

PURPOSE: To compare the repair of penetrating corneal incisions in an in vivo rabbit model using a laser-activated thin-film adhesive, sutures, or self-seal. SETTING: The University of Sydney, Camperdown, Australia. DESIGN: Animal studies. METHODS: Under an operating microscope, 2.0 mm penetrating incisions were created in 162 right eyes. Incisions in one group were repaired with the adhesive, the second group received a single 10-0 nylon suture, and the third group was left to self-seal. Rabbits were killed humanely at predetermined timepoints over 2 weeks, and wound healing was assessed using burst pressure and immunohistological studies. A modified McDonald-Shadduck scoring was used to assess eyes. RESULTS: The mean burst pressure of the adhesive group was significantly higher than the sutured or self-sealed groups at all timepoints within the first 72 hours. At 0 hour, the burst pressure was 98.0 (±17.0) mm Hg, 30.6 (±2.1) mm Hg, and 3.8 (±0.6) mm Hg (P < .00001) for adhesive-treated (n = 5), sutured (n = 5), and self-sealed wounds (n = 5), respectively. These increased to 229.0 (±53.7) mm Hg, 12.4 (±2.9) mm Hg, and 27.3 (±4.0) mm Hg (P = .0011) at 72 hours. The modified McDonald-Shadduck score was significantly higher for eyes repaired using the adhesive than those sutured or left to self-seal for the first 72 hours. On histology and immunofluorescence, adhesive treatment demonstrated better wound approximation and higher myofibroblastic activation than the other groups. CONCLUSIONS: The adhesive was efficacious in sealing penetrating corneal incisions and tolerated higher burst pressures than sutures or self-seal. The adhesive was biocompatible in rabbits, and incisions demonstrated a rapid gain in wound strength that sustained over the study period.

Laser-Activated Corneal Adhesive: Retinal Safety in Rabbit Model.

Purpose: The purpose of this study was to investigate whether laser irradiation, used to activate an adhesive for sealing penetrating corneal incisions, causes any ophthalmoscopically or histologically visible retinal changes. Methods: Baseline fundus assessment was conducted prior to laser irradiation of eyes of pigmented Dutch Belted rabbits. Treatment group was 18 eyes with the corneal adhesive activated in situ by a near infrared laser (125 mW for 45 seconds). The positive control group was 18 eyes, each irradiated for 60 seconds at 375, 500, 625, and 750 mW at different retinal locations. Unexposed regions of the retina were used as negative internal control. Ophthalmoscopic assessment was conducted immediately after laser exposure and prior to euthanasia. Retinas were histologically assessed at 0, 3, 72, and 168 hours after treatment. Results: No ophthalmoscopically or histologically visible retinal changes were observed in the treatment group immediately, nor up to 168 hours after laser irradiation. In the positive control group, the incidences of ophthalmoscopically visible retinal lesions increased with irradiation power: 5.6% at 375 mW, 16.7% at 500 mW, 44.4% at 625 mW, and 50% at 750 mW. Histologically, retinal damage was observed as coagulative necrosis to all layers of the neural retina, including the retinal pigment epithelium. Conclusions: The laser irradiation process used in the corneal adhesive technology did not cause any ophthalmoscopically or histologically visible retinal changes in the in vivo pigmented rabbit model. Prolonged exposure with this laser and at higher power can cause coagulative necrosis to the retina. Translational Relevance: The corneal adhesive can be applied in humans without causing laser retinal damage.

Using Humidity to Control the Morphology and Properties of Electrospun BioPEGylated Polyhydroxybutyrate Scaffolds.

Electrospinning produces nanofibrous scaffolds with potential for tissue engineering and wound repair. Spinning parameters control scaffold morphology and properties. BioPEGylation of polyhydroxybutyrate (PHB) introduces terminal hydrophilic groups into the hydrophobic chain, making this natural-synthetic hybrid copolymer more susceptible to humidity. Varying the humidity from 10 to 50% RH during electrospinning had a relatively little effect on polyhydroxybutyrate (PHB) average fiber and pore diameters, which remained around 3.0 and 8.7 µm, respectively. In contrast, fiber and pore diameters for electrospun bioPEGylated PHB scaffolds varied significantly with humidity, peaking at 30% RH (5.5 and 14.1 µm, respectively). While scaffolds showed little change, hydrophobicity decreased linearly with humidity during electrospinning. Compared to solvent-cast films, electrospun scaffolds showed significantly greater average cell spread. A 108% increase for olfactory ensheathing cells (OECs) cultivated on bioPEGylated PHB scaffolds was proportionally greater than their counterparts on electrospun PHB scaffolds, (70%). OECS grown on BioPEGylated PHB scaffolds were over twice the size, 260 ± 20 µm diameter, than those on PHB electrospun scaffolds, 110 ± 18 µm diameter. Electrospun scaffolds also promoted cell health compared to their solvent-cast counterparts, with increases in the mitochondrial activity of 165 ± 13 and 196 ± 13% for PHB and bioPEGylated PHB, respectively. OECS cultivated on electrospun scaffolds of bioPEGylated PHB had significantly better membrane integrities compared to their counterparts on solvent-cast films, 47 ± 5% reducing to 17 ± 6%. The combination of bioPEGylation and humidity during electrospinning permitted significant controllable changes to scaffold morphology and properties. These changes resulted in the significantly greater promotion of cell growth on electrospun bioPEGylated PHB scaffolds compared to their solvent-cast counterparts and electrospun PHB.

Corneal Sealants in Clinical Use: A Systematic Review.

AIM: To review the use of clinical corneal sealants for the closure of full thickness corneal wounds. METHODS: A systematic review was conducted across CENTRAL, Medline, PubMed, Embase, Scopus, mRCT and ICTRP for the keywords of 'cornea', 'full-thickness wound', 'sealant' and their synonyms. Only evidence level 2 of higher as graded by Oxford Centre of Evidence-based Medicine were included for this review. RESULTS: Seven studies were included; three randomized controlled trials investigated ReSure® sealant, 2 OcuSeal®, 1 human fibrin glue vs cyanoacrylate and 1 human fibrin glue as an adjunct to sutures vs sutures alone in penetrating keratoplasty. ReSure® was superior to suture for sealing leaking corneal incisions after cataract surgery despite provocation. ReSure® sealant has not been tested on complex full thickness corneal wounds, perforated ulcers or penetrating keratoplasty. OcuSeal® was also able to seal full thickness cornea wound post-cataract surgery to prevent ingress of Trypan blue dye. Human fibrin glue and cyanoacrylate were similarly effective in treating corneal perforations <3 mm of mixed etiologies. CONCLUSION: There are limited high-level evidence for corneal sealants. The currently available sealants with human data are ReSure®, OcuSeal®, human fibrin glue and cyanoacrylates. While ReSure® and OcuSeal® are effective post-cataract surgery, there are no data for perforations from other etiologies. Post-approval data from ReSure® registry report good tolerability and no apparent safety concerns.

Sutureless nerve repair with ECM bioscaffolds and laser-activated chitosan adhesive.

The outcome of peripheral nerve repair following transection is influenced by a number of factors but almost all approaches require anastomosis of the nerve using technically demanding microsurgical procedures. However, the use of sutures presents a number of unavoidable challenges including additional nerve trauma, stimulation of an inflammatory response, and endoneural fibrosis. The objective of the present study was to determine the efficacy of a sutureless approach to nerve repair. A rat sciatic nerve transection model was used with a laser-activated, chitosan-based adhesive (SurgiLux), combined with different forms of extracellular matrix (ECM), known to promote Schwann cell proliferation and nerve growth both in peripheral nerve applications. Following a 5 mm transection of the sciatic nerve, nerve guide wraps were prepared using: (1) laser-activated adhesive (SurgiLux) alone, (2) SurgiLux incorporating ECM (SurgiLux ECM), (3) ECM secured using SurgiLux, and (4) ECM secured using 8-0 Prolene sutures. A no treatment groups was used as a negative control. Evaluation of tissue remodeling was conducted with histolomorphometric assessment of neuroma, integrity of repair, nerve immunolabeling, ratio of myelinated to non-myelinated fibers, and amount of connective tissue. Quantitative and semi-quantitative analysis of the repaired nerve transections at 6 and 12 weeks showed that that SurgiLux incorporating powdered ECM (SurgiLux ECM), SurgiLux alone and ECM alone all improved the healing response compared to no-treatment controls, with less fibrotic tissue and more nerve staining. Histologic scoring showed that the SurgiLux ECM group showed the greatest increase in histologic score between the two time points tested. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 1698-1711, 2018.

Chitosan as a Biomaterial: Influence of Degree of Deacetylation on Its Physiochemical, Material and Biological Properties.

Chitosan is a biomaterial with a range of current and potential biomedical applications. Manipulation of chitosan degree of deacetylation (DDA) to achieve specific properties appears feasible, but studies investigating its influence on properties are often contradictory. With a view to the potential of chitosan in the regeneration of nerve tissue, the influence of DDA on the growth and health of olfactory ensheathing cells (OECs) was investigated. There was a linear increase in OEC proliferation as the DDA increased from 72 to 85%. This correlated with linear increases in average surface roughness (0.62 to 0.78 µm) and crystallinity (4.3 to 10.1%) of the chitosan films. Mitochondrial activity and membrane integrity of OECs was significantly different for OECs cultivated on chitosan with DDAs below 75%, while those on films with DDAs up to 85% were similar to cells in asynchronous growth. Apoptotic indices and cell cycle analysis also suggested that chitosan films with DDAs below 75% were cytocompatible but induced cellular stress, while OECs grown on films fabricated from chitosan with DDAs above 75% showed no significant differences compared to those in asynchronous growth. Tensile strength and elongation to break varied with DDA from 32.3 to 45.3 MPa and 3.6 to 7.1% respectively. DDA had no significant influence on abiotic and biotic degradation profiles of the chitosan films which showed approximately 8 and 20% weight loss respectively. Finally, perceived patterns in property changes are subject to change based on potential variations in DDA analysis. NMR examination of the chitosan samples here revealed significant differences depending upon which peaks were selected for integration; 6 to 13% in DDA values within individual samples. Furthermore, differences between DDA values determined here and those reported by the commercial suppliers were significant and this may also be a source of concern when selecting commercial chitosans for biomaterial research.

Towards scarless wound healing: a comparison of protein expression between human, adult and foetal fibroblasts.

Proteins from human adult and foetal fibroblast cell lines were compared, focusing on those involved in wound healing. Proteins were separated through two-dimensional gel electrophoresis (2DE). Differences in protein spot intensity between the lineages were quantified through 3D gel scanning densitometry. Selected protein spots were excised, subjected to tryptic digests, prior to separation using HPLC with a linear ion trap mass spectrometer, and identified. Protein maps representing the proteomes from adult and foetal fibroblasts showed similar distributions but revealed differences in expression levels. Heat shock cognate 71 kDA protein, Tubulin alpha-1A chain, actin cytoplasmic-1, and neuron cytoplasmic protein were all expressed in significantly higher concentrations by foetal fibroblasts, nearly double those observed for their adult counterparts. Fructose bisphosphate aldolase A, Cofilin-1, Peroxiredoxin-1, Lactotransferrin Galectin-1, Profilin-1, and Calreticulin were expressed at comparatively higher concentrations by the adult fibroblasts. Significant differences in the expression levels of some proteins in human adult and foetal fibroblasts correlated with known differences in wound healing behaviour. This data may assist in the development of technologies to promote scarless wound healing and better functional tissue repair and regeneration.

Nine states' use of collaboratives to improve children's health care quality in medicaid and CHIP.

We examine quality improvement (QI) collaboratives underway in 9 states participating in the Children's Health Insurance Program Reauthorization Act (CHIPRA) Quality Demonstration Grant Program. A total of 147 diverse, child-serving practices were participating in the collaboratives. We conducted 256 semistructured interviews with key stakeholders from March to August 2012-2 years into the 5-year demonstration projects-and analyzed states' grant applications, operating plans, and progress reports. The collaboratives have multiple complex aims. In addition to developing patient-centered medical home (PCMH) capability, some states use collaboratives to familiarize practices with CMS's Initial Core Set of Children's Health Care Quality Measures, practice-level quality measurement, and improving QI knowledge and skills. The duration of the collaboratives is longer than other well-known collaborative models. Collaboratives also vary in their methods for targeting areas for improvement and strategies for motivating practice recruitment and engagement. States also vary with respect to the other strategies they use to support QI and PCMH development. All states supplement the collaboratives with practice facilitation; the majority utilized practice-level parent engagement, but only 4 used workforce augmentation (ie, providing care coordinators and QI specialists). Practice staff highly valued aspects of the collaboratives and supplemental strategies, including the opportunity to work with experts and other child-serving practices; states' efforts to provide stipends and align demonstration efforts with other professional requirements or programs; receipt of relevant, customized QI materials; opportunities to learn how care coordinators or QI specialists might work in their practice without the risk of hiring them; and satisfaction from learning more about quality measures, QI concepts and techniques, critical medical home components, and how to identify PCMH capacity and performance gaps. However, practice staff also reported a variety of challenges, including difficulty learning from other practices that have very different preexisting QI and PCMH capacity and patient populations, or that are working on different topic areas and measures; a sometimes overwhelming amount of materials and ideas covered during in-person meetings; difficulty keeping up with Webinars, calls, and Web sites/blogs; and trouble motivating and sharing information with other practice staff not attending collaborative activities. As the demonstration projects continue, states and the national evaluation team will learn more about how best to use collaboratives and complementary strategies to support child-serving practices in QI and PCMH development. States will also search for ways to sustain and spread these activities after the demonstration ends, if they prove effective.

A tuneable switch for controlling environmental degradation of bioplastics: addition of isothiazolinone to polyhydroxyalkanoates.

Controlling the environmental degradation of polyhydroxybutyrate (PHB) and polyhydroxyvalerate (P(HB-co-HV)) bioplastics would expand the range of their potential applications. Combining PHB and P(HB-co-HV) films with the anti-fouling agent 4,5-dichloro-2-n-octyl-4-isothiazolin-3-one (DCOI, <10% w/w) restricted microbial colonisation in soil, but did not significantly affect melting temperature or the tensile strength of films. DCOI films showed reduced biofouling and postponed the onset of weight loss by up to 100 days, a 10-fold increase compared to unmodified films where the microbial coverage was significant. In addition, the rate of PHA-DCOI weight loss, post-onset, reduced by about 150%; in contrast a recorded weight loss of only 0.05% per day for P(HB-co-HV) with a 10% DCOI loading was observed. This is in stark contrast to the unmodified PHB film, where a recorded weight loss of only 0.75% per day was made. The 'switch' that initiates film weight loss, and its subsequent reduced rate, depended on the DCOI loading to control biofouling. The control of biofouling and environmental degradation for these DCOI modified bioplastics increases their potential use in biodegradable applications.

Diversity of microbial species implicated in keratitis: a review.

BACKGROUND: Microbial keratitis is an infectious disease of the cornea characterised by inflammation and is considered an ophthalmic emergency requiring immediate attention. While a variety of pathogenic microbes associated with microbial keratitis have been identified, a comprehensive review identifying the diversity of species has not been completed. METHODS: A search of peer-reviewed publications including case reports and research articles reporting microorganims implicated in keratitis was conducted. Search engines including PubMed, Scopus and Web of Science with years ranging from 1950-2012 were used. RESULTS: 232 different species from 142 genera, representing 80 families were found to be implicated in microbial keratitis. Fungi exhibited the largest diversity with 144 species from 92 genera. In comparison, 77 species of bacteria from 42 genera, 12 species of protozoa from 4 genera and 4 types of virus were identified as the infectious agents. A comparison of their aetiologies shows reports of similarities between genera. CONCLUSIONS: The diversity of microbial species implicated in keratitis has not previously been reported and is considerably greater than suggested by incidence studies. Effective treatment is heavily reliant upon correct identification of the responsible microorganisms. Species identification, the risk factors associated with, and pathogenesis of microbial keratitis will allow the development of improved therapies. This review provides a resource for clinicians and researchers to assist in identification and readily source treatment information.

Back pain during war: an analysis of factors affecting outcome.

BACKGROUND: Back pain is the leading cause of disability in the world, but it is even more common in soldiers deployed for combat operations. Aside from battle injuries and psychiatric conditions, spine pain and other musculoskeletal conditions are associated with the lowest return-to-unit rate among service members medically evacuated out of Operations Iraqi and Enduring Freedom. METHODS: Demographic, military-specific, and outcome data were prospectively collected over a 2-week period at the Deployed Warrior Medical Management Center in Germany on 1410 consecutive soldiers medically evacuated out of theaters of combat operations for a primary diagnosis pertaining to back pain between 2004 and 2007. The 2-week period represents the maximal allowable time an evacuated soldier can spend in treatment before disposition (ie, return to theater or evacuate to United States) is rendered. Electronic medical records were then reviewed to examine the effect a host of demographic and clinical variables had on the categorical outcome measure, return to unit. RESULTS: The overall return-to-unit rate was 13%. Factors associated with a positive outcome included female sex, deployment to Afghanistan, being an officer, and a history of back pain. Trends toward not returning to duty were found for navy and marine service members, coexisting psychiatric morbidity, and not being seen in a pain clinic. CONCLUSIONS: The likelihood of a service member medically evacuated out of theater with back pain returning to duty is low irrespective of any intervention(s) or characteristic(s). More research is needed to determine whether concomitant treatment of coexisting psychological factors and early treatment "in theater" can reduce attrition rates.

The accuracy of physicians' perceptions of patients' suffering: findings from two teaching hospitals.

PURPOSE: How accurately physicians perceive patient suffering remains unclear. The authors sought to quantitatively compare physicians' estimates of their patients' suffering with the patients' ratings of their own suffering, using a paired survey. METHOD: Six major domains of suffering (DOSs) were derived from narrative descriptions of suffering by physicians and patients in a preliminary multicenter pilot study. From September 2005 through July 2006 at two teaching hospitals in Washington, DC, and Bethesda, Maryland, before a clinical encounter between a patient and physician, patients rated the impact of each of these DOSs on their overall suffering. After the same encounter, physicians rated the same DOSs according to their perception of suffering experienced by that patient. Patient responses were compared with physician responses using the Wilcoxon signed ranks and Spearman correlation tests. RESULTS: Two hundred twenty-seven adult patients and their treating physicians completed the survey. Cooperation rates among patients and physicians were 94% and 97%, respectively. For two of the six DOSs (pain and physically nonpainful symptoms), there was no significant difference between the physicians' estimates of suffering and the patients' ratings of the DOS. For the remaining four DOSs (communication, emotional factors, loss, and systems factors), there was significant disagreement between the physicians' estimates and the actual suffering of the patients (P < .01). When all six DOSs were combined to ascertain how well perceptions of overall suffering correlated, significant discordance was also observed between physicians' perceptions and patients' descriptions (P < .001). CONCLUSIONS: This study suggests that the physicians who participated might need more training in the recognition of patient suffering. Because these physicians were trained in medical schools across the country, the deficiencies noted here may not be limited to only the physicians in this study. More studies of physicians' ability to detect and manage suffering are needed, especially at nonteaching hospitals.

Comparison of fluoroscopically guided and blind corticosteroid injections for greater trochanteric pain syndrome: multicentre randomised controlled trial.

OBJECTIVE: To determine whether fluoroscopic guidance improves outcomes of injections for greater trochanteric pain syndrome. DESIGN: Multicentre double blind randomised controlled study. SETTING: Three academic and military treatment facilities in the United States and Germany. PARTICIPANTS: 65 patients with a clinical diagnosis of greater trochanteric pain syndrome. INTERVENTIONS: Injections of corticosteroid and local anaesthetic into the trochanteric bursa, using fluoroscopy (n=32) or landmarks (that is, "blind" injections; n=33) for guidance. PRIMARY OUTCOME MEASURES: 0-10 numerical rating scale pain scores at rest and with activity at one month (positive categorical outcome predefined as >or=50% pain reduction either at rest or with activity, coupled with positive global perceived effect). Secondary outcome measures included Oswestry disability scores, SF-36 scores, reduction in drug use, and patients' satisfaction. RESULTS: No differences in outcomes occurred favouring either the fluoroscopy or blind treatment groups. One month after injection the average pain scores were 2.7 at rest and 5.0 with activity in the fluoroscopy group compared with 2.2 and 4.0 in the blind injection group. Three months after the injection, 15 (47%) patients in the blind group and 13 (41%) in the fluoroscopy group continued to have a positive outcome. CONCLUSION: Although using fluoroscopic guidance dramatically increases treatment costs for greater trochanteric pain syndrome, it does not necessarily improve outcomes. TRIAL REGISTRATION: Clinical trials NCT00480675.

Intradermal botulinum toxin type A injection effectively reduces residual limb hyperhidrosis in amputees: a case series.

OBJECTIVE: To study the effectiveness of botulinum toxin type A (BTX-A) therapy for residual limb hyperhidrosis, prosthesis fit and function, and residual and phantom limb pain in patients with limb amputation. DESIGN: Consecutive case series. SETTING: Outpatient physical medicine and rehabilitation clinic. PARTICIPANTS: Walter Reed Army Medical Center patients (N=8) with unilateral traumatic upper- or lower-limb amputation. INTERVENTION: BTX-A was injected transdermally in a circumferential pattern around the residual limb by using a 1-cm matrix grid. MAIN OUTCOME MEASURE: A 10-cm continuous Likert visual analog scale was used to assess residual limb sweating and pain and prosthesis fit and function before and 3 weeks after BTX-A injections. RESULTS: Patients reported a significant reduction in sweating and improvement in prosthesis fit and function after treatment. However, residual limb and phantom pain were unaffected by treatment. CONCLUSIONS: BTX-A may be an effective treatment for residual limb hyperhidrosis, resulting in subjective improvement in prosthesis fit and functioning. BTX-A should be considered as a method to manage excessive sweating in the residual limb of traumatic amputees.

Sutureless nerve repair with laser-activated chitosan adhesive: a pilot in vivo study.

OBJECTIVE: The anastomosis of peripheral nerves is a demanding procedure that has potential complications due to foreign body reactions elicited by sutures. In this study, the sutureless in vivo anastomosis of rat tibial nerves was successfully performed, using for the first time a chitosan-based laser-activated adhesive. The nerve thermal damage caused by the laser irradiation was quantitatively assessed. MATERIALS AND METHODS: A novel adhesive composed of chitosan, indocyanine green, acetic acid, and water, was fabricated in thin sheets. Its adhesive strength was tested in vitro by bonding strips (surface area approximately 20 mm2, thickness approximately 20 microm) onto rat sciatic nerves and sheep intestine by laser activation with low fluence ( approximately 50 J/cm2), using a fiber-coupled diode laser (n = 13). The tensile strength of the adhesive/tissue bonds was measured after tissue repair. The chitosan adhesive was then used to perform sutureless anastomosis of tibial nerves in vivo (n = 6). Adhesive strips were also bonded in vivo onto intact rat sciatic nerves (n = 6) in order to quantitatively assess, by counting myelinated axons, the thermal damage induced by the laser. RESULTS: The adhesive bonded well to tissue with a tensile strength of 12.5 +/- 2.6 KPa (mean +/- SD; n = 13). The in vivo anastomosed nerves were in continuity 3 d after surgery. Axon counting showed the number and morphology of myelinated axons were normal proximally ( approximately 96%) compared with intact nerves (100%). Axon demyelination was observed at the operation site ( approximately 49%) and distally ( approximately 27%), and was attributed to laser-induced thermal damage. CONCLUSIONS: Nerve anastomosis, performed by the laser-adhesive procedure, was successful 3 d postoperatively. Proximal myelinated axons were not significantly damaged by the low laser fluence.

Neonatal mortality risk related to birth weight and gestational age in British Columbia.

OBJECTIVES: To provide gender-specific neonatal mortality grids depicting relative risk in narrow birth weight ranges at each week of gestation. The grids will provide practitioners with clinically relevant information pertinent to pregnancy, delivery, and postnatal care in Canada. METHODS: Records from the British Columbia Vital Statistics Agency birth and death registries from 1981 to 2000 were deterministically linked and resulted in a 99.86% linkage rate. Risk ratios were computed by dividing percent neonatal mortality in 250 g birth weight categories at each week of gestation by the overall gender-specific mortality rates for the full period. We adjusted random rate fluctuations that were due to low frequencies in the narrow birth weight and gestational age strata. RESULTS: Females exhibited greater survival across the full spectrum of birth weight by gestational age strata, but their mortality configurations were noticeably different from those of males. In addition, there were demarcations in both grids that depicted relatively abrupt changes in risk ratios. Although the crude mortality rates in BC decreased during the study period, the use of risk ratios reduced the disparity in crude rates over time. CONCLUSION: These gender-specific mortality grids refine and enhance previously available comparisons by portraying neonatal mortality risks in narrow birth weight ranges at each week of gestation.

Consumer enrollment and experiences in the Cash and Counseling program.

STUDY CONTEXT: Consumer direction of Medicaid supportive services raises concerns about who should be permitted to self-direct, whether consumers should be allowed to pay family members, whether a self-directed option increases demand for services, and how to ensure quality. The Cash and Counseling programs contained features designed to address these concerns. DEMONSTRATION ENROLLMENT: Many consumers used representatives to manage the allowance on their behalf and others chose to disenroll, suggesting that beneficiaries were capable of deciding for themselves whether the programs were suitable for them. Participation among eligible beneficiaries during the demonstration was modest, suggesting that consumer direction did not itself substantially increase the demand for services. CONSUMER EXPERIENCES: Most consumers were able to assume the role of employer without difficulty, many hiring relatives or acquaintances as workers. In each state, more than 85 percent reported they would recommend the program to others seeking more control over their care, and more than half said the program had "improved their lives a great deal."

Effects of Cash and Counseling on personal care and well-being.

OBJECTIVE: To examine how a new model of consumer-directed care changes the way that consumers with disabilities meet their personal care needs and, in turn, affects their well-being. STUDY SETTING: Eligible Medicaid beneficiaries in Arkansas, Florida, and New Jersey volunteered to participate in the demonstration and were randomly assigned to receive an allowance and direct their own Medicaid supportive services as Cash and Counseling consumers (the treatment group) or to rely on Medicaid services as usual (the control group). The demonstration included elderly and non-elderly adults in all three states and children in Florida. DATA SOURCES: Telephone interviews administered 9 months after random assignment. METHODS: Outcomes for the treatment and control group were compared, using regression analysis to control for consumers' baseline characteristics. PRINCIPAL FINDINGS: Treatment group members were more likely to receive paid care, had greater satisfaction with their care, and had fewer unmet needs than control group members in nearly every state and age group. However, among the elderly in Florida, Cash and Counseling had little effect on these outcomes because so few treatment group members actually received the allowance. Within each state and age group, consumers were not more susceptible to adverse health outcomes or injuries under Cash and Counseling. CONCLUSIONS: Cash and Counseling substantially improves the lives of Medicaid beneficiaries of all ages if consumers actually receive the allowance that the program offers.

How caregivers and workers fared in Cash and Counseling.

OBJECTIVES: To assess the effects of Cash and Counseling on Medicaid beneficiaries' primary informal caregivers and describe the experiences of their directly hired workers. STUDY SETTING: Beneficiaries in Arkansas, Florida, and New Jersey voluntarily enrolled in the demonstration and were randomly assigned to direct their own Medicaid supportive services as Cash and Counseling consumers (the treatment group) or to rely on Medicaid services as usual (the control group). Beneficiaries identified their primary informal caregiver during a baseline interview and their primary paid worker during a 9-month follow-up interview. DATA SOURCES: Data were collected through telephone interviews with caregivers and workers. These interviews were conducted about 10 months after beneficiaries' random assignment, between February 2000 and May 2003, depending on the state. DATA ANALYSIS METHODS: We estimated program effects with regression and logit models and compared the mean characteristics of directly hired workers and agency workers, by state. PRINCIPAL FINDINGS: Compared with caregivers in the control group, those in the treatment group had modestly to substantially better outcomes for measures of satisfaction with care, worry, and physical and financial strain. For hours of care and emotional strain, outcomes in the treatment group were similar to or somewhat better than those in the control group. Directly hired workers reported greater satisfaction with wages, similar satisfaction with working conditions, and similar rates of injuries as agency workers. Workers who were related to the beneficiary reported more emotional strain than agency workers. CONCLUSIONS: Cash and Counseling can lessen some of the burden associated with caring for a child or adult with disabilities. The experiences of hired workers suggest consumer direction is a sustainable option, but support networks for workers might be a welcome program improvement.