Diverting Data and Drugs: A Narrative Review of the Mallinckrodt Documents.

U.S. law imposes strict recording and reporting requirements on all entities that manufacture and distribute controlled substances. As a result, the prescription opioid crisis has unfolded in a data-saturated environment. This article asks why the systematic documentation of opioid transactions failed to prevent or mitigate the crisis. Drawing on a recently disclosed trove of 1.4 million internal records from Mallinckrodt Pharmaceuticals, a leading manufacturer of prescription opioids, we highlight a phenomenon we propose to call data diversion, whereby data ostensibly generated or collected for the purpose of regulating the distribution of controlled substances were repurposed by the industry for the opposite aim of increasing sales at all costs. Systematic data diversion, we argue, contributed substantially to the scale of drug diversion seen with opioids and should become a focus of policy intervention.

Cerebral Palsy: Current Concepts and Practices in Musculoskeletal Care.

Cerebral palsy is a neurologic disorder characterized by a spectrum of motor and cognitive deficits resulting from insults to the developing brain. The etiologies are numerous and likely multifactorial; an increasing portion of cases may be attributable to genetic causes, although the exact mechanisms responsible remain poorly understood. Major risk factors include intrauterine stroke and prematurity and neonatal infection, trauma, and hypoxia, which may occur in the prenatal, perinatal, or postnatal period. The Gross Motor Function Classification System (GMFCS) is a widely used tool to establish a child's level of function and to guide treatment; however, additional metrics are necessary to formulate long-term prognoses. Goals of care are to maximize function and independence, which directly correlate with overall quality of life, and family participation is key to establishing goals early in treatment. Nonpharmaceutical treatments include physical, occupational, and speech therapy, as well as bracing, equipment, and technology. There is a breadth of medical interventions for managing hypertonia, including medications, botulinum toxin injections, intrathecal baclofen pumps, and selective dorsal rhizotomy. Orthopedic interventions are indicated for symptomatic or progressive musculoskeletal sequelae. Treatments for dysplastic hips and/or hip instability range from soft tissue releases to bony procedures. Neuromuscular scoliosis is managed with posterior spinal fusion because bracing is ineffective against these rapidly progressive curves. The degree of care varies considerably depending on the child's baseline GMFCS level and functional capabilities, and early screening, diagnosis, and appropriate referrals are paramount to initiating early care and maximizing the child's quality of life.

Behavioral dysregulation exacerbated by intrathecal baclofen in an adolescent with severe traumatic brain injury.

This is a case of a 19-year-old male with a history of remote severe traumatic brain injury (TBI) with an intrathecal baclofen (ITB) pump for dystonia management. Given concern for lack of efficacy despite increasing doses of ITB, his catheter was evaluated and found to be epidural rather than intrathecal. The baclofen dose was down-titrated and he underwent catheter revision. Post-op, his baclofen dose was up-titrated and complicated by significant behavioral changes including aggressive physical and verbal behaviors resulting in hospitalization. Work-up was negative for infection, new neurologic pathology, and epileptic activity. Psychiatric medications were adjusted but the behaviors persisted. Due to concern that the increased baclofen dose was causing his mood instability, his pump was down-titrated. As the dosage decreased, the frequency of outbursts also decreased. Throughout these dose adjustments, his dystonia remained stable and overall functional status improved. This is one of the first cases demonstrating that ITB may exacerbate mood instability in patients with TBI.

Combined Selective Dorsal Rhizotomy and Single-Event Multilevel Surgery in a Child with Spastic Diplegic Cerebral Palsy: A Case Report.

INTRODUCTION: Children with spastic diplegic cerebral palsy (CP) often have functional and gait impairments related to spasticity and loss of range of motion (ROM). Selective dorsal rhizotomy (SDR) and single-event multilevel surgery (SEMLS) are surgical interventions that are used to manage spasticity and functional gait impairments, respectively. This is the first known case report of a child with spastic diplegic CP who underwent combined SDR and SEMLS. CASE REPORT: Our patient is a 7-year-old girl with spastic diplegic CP, functioning at the Gross Motor Function Classification System (GMFCS) level II, who presented with spasticity and contractures in bilateral lower extremities leading to functional gait impairments, despite conservative management. Combined SDR/SEMLS was offered with the goal of simultaneously managing spasticity and contractures while reducing the need for multiple procedures. Postoperatively, the patient's functional mobility, ROM, spasticity, and strength were assessed at various follow-up intervals. The patient had increased lower extremity weakness and functional decline postoperatively. Persistent genu recurvatum and knee instability required prolonged rehabilitation services, and she demonstrated functional gains with these interventions. At follow-ups, spasticity was resolved and ROM improved. By the 12-month follow-up, the Gross Motor Function Measure-66 was improved to 68.9 (55th percentile) from the preoperative level of 62.1 (35th percentile). By the 30-month follow-up, she was able to participate in novel recreational activities. DISCUSSION/CONCLUSION: Multidisciplinary teams may consider combined SDR/SEMLS for management of spasticity, gait impairment, and contracture in carefully selected patients with spastic CP.

Pediatric intrathecal baclofen management during the COVID-19 pandemic in the US and Canada.

The COVID-19 pandemic has been a challenge to healthcare systems around the world. Within pediatric rehabilitation medicine, management of intrathecal baclofen has been particularly challenging. This editorial reviews how programs in the US and Canada coped with the quickly changing healthcare environment and how we can learn from this pandemic to be prepared for future crises.

Accelerometer Measurements Indicate That Arm Movements of Children With Cerebral Palsy Do Not Increase After Constraint-Induced Movement Therapy (CIMT).

IMPORTANCE: Constraint-induced movement therapy (CIMT) is a common treatment for children with unilateral cerebral palsy (CP). Although clinic-based assessments have demonstrated improvements in arm function after CIMT, whether these changes are translated and sustained outside of a clinic setting remains unclear. OBJECTIVE: Accelerometers were used to quantify arm movement for children with CP 1 wk before, during, and 4 wk or more after CIMT; measurements were compared with those from typically developing (TD) peers. DESIGN: Observational. SETTING: Tertiary hospital and community. PARTICIPANTS: Seven children with CP (5 boys, 2 girls; average [AVE] age ± standard deviation [SD] = 7.4 ± 1.2 yr) and 7 TD peers (2 boys, 5 girls; AVE age ± SD = 7.0 ± 2.3 yr). INTERVENTION: 30-hr CIMT protocol. OUTCOMES AND MEASURES: Use ratio, magnitude ratio, and bilateral magnitude were calculated from the accelerometer data. Clinical measures were administered before and after CIMT, and parent surveys assessed parent and child perceptions of wearing accelerometers. RESULTS: During CIMT, the frequency and magnitude of paretic arm use among children with CP increased in the clinic and in daily life. After CIMT, although clinical scores showed sustained improvement, the children's accelerometry data reverted to baseline values. Children and parents in both cohorts had positive perceptions of accelerometer use. CONCLUSIONS AND RELEVANCE: The lack of sustained improvement in accelerometry metrics after CIMT suggests that therapy gains did not translate to increased movement outside the clinic. Additional therapy may be needed to help transfer gains outside the clinic. WHAT THIS ARTICLE ADDS: Accelerometer measurements were effective at monitoring arm movement outside of the clinic during CIMT and suggested that additional interventions may be needed after CIMT to sustain benefits.

Feasibility of using acceleration-derived jerk to quantify bimanual arm use.

BACKGROUND: Accelerometers have become common for evaluating the efficacy of rehabilitation for patients with neurologic disorders. For example, metrics like use ratio (UR) and magnitude ratio (MR) have been shown to differentiate movement patterns of children with cerebral palsy (CP) compared to typically-developing (TD) peers. However, these metrics are calculated from "activity counts" - a measure based on proprietary algorithms that approximate movement duration and intensity from raw accelerometer data. Algorithms used to calculate activity counts vary between devices, limiting comparisons of clinical and research results. The goal of this research was to develop complementary metrics based on raw accelerometer data to analyze arm movement after neurologic injury. METHOD: We calculated jerk, the derivative of acceleration, to evaluate arm movement from accelerometer data. To complement current measures, we calculated jerk ratio (JR) as the relative jerk magnitude of the dominant (non-paretic) and non-dominant (paretic) arms. We evaluated the JR distribution between arms and calculated the 50th percentile of the JR distribution (JR50). To evaluate these metrics, we analyzed bimanual accelerometry data for five children with hemiplegic CP who underwent Constraint-Induced Movement Therapy (CIMT) and five typically developing (TD) children. We compared JR between the CP and TD cohorts, and to activity count metrics. RESULTS: The JR50 differentiated between the CP and TD cohorts (CP = 0.578 ± 0.041 before CIMT, TD = 0.506 ± 0.026), demonstrating increased reliance on the dominant arm for the CP cohort. Jerk metrics also quantified changes in arm use during and after therapy (e.g., JR50 = 0.378 ± 0.125 during CIMT, 0.591 ± 0.057 after CIMT). The JR was strongly correlated with UR and MR (r = - 0.92, 0.89) for the CP cohort. For the TD cohort, JR50 was repeatable across three data collection periods with an average similarity of 0.945 ± 0.015. CONCLUSIONS: Acceleration-derived jerk captured differences in motion between TD and CP cohorts and correlated with activity count metrics. The code for calculating and plotting JR is open-source and available for others to use and build upon. By identifying device-independent metrics that can quantify arm movement in daily life, we hope to facilitate collaboration for rehabilitation research using wearable technologies.

A Novel Protocol for Contact Isolation for Multidrug-Resistant Organisms in Children on Inpatient Rehabilitation and Effects on Functional Outcomes: A Noninferiority Study.

BACKGROUND: The incidence of contact isolation for multidrug-resistant organisms is increasing in acute hospitals and inpatient rehabilitation units alike. There is limited evidence on the effect of contact isolation on functional outcomes during inpatient rehabilitation. OBJECTIVE: To determine whether the use of a modified contact isolation protocol (MCI) resulted in noninferior functional outcomes compared with children without contact isolation (NCI) on inpatient rehabilitation. DESIGN: This is a retrospective noninferiority study. SETTING: One academically affiliated pediatric inpatient rehabilitation unit located in a children's hospital. PATIENTS: All children with any diagnosis admitted to inpatient rehabilitation from January 1, 2007, to December 31, 2014. METHODS OR INTERVENTIONS: We compared functional outcomes for 2 groups of children. MAIN OUTCOME MEASUREMENTS: Primary outcome measures included the Functional Independence Measure for Children (WeeFIM) efficiency and the change in the Developmental Functional Quotient (DFQ) for the WeeFIM. Noninferiority margins of 0.63 for the WeeFIM efficiency and 0.092 for the change in DFQ for the WeeFIM were used. RESULTS: There were a total of 949 patients of whom 899 were NCI, 48 MCI, and 2 excluded due to missing information. Patients with MCI had functional outcomes that were noninferior to those with NCI including the WeeFIM efficiency (mean difference 0.002, 95% CI -0.38 to 0.404) and the change in DFQ for the WeeFIM (mean difference -0.05, 95% CI -0.058 to 0.003). CONCLUSIONS: The modified contact isolation protocol, having resulted in noninferior functional outcomes in inpatient rehabilitation may provide adequate contact isolation while allowing for noninferior functional outcomes. This may be a guide in the face of an ever-increasing need for contact isolation. LEVEL OF EVIDENCE: III.

Oral Health Care of Vietnamese Adolescents: A Qualitative Study of Perceptions and Practices.

PURPOSE: To explore the oral health perceptions and practices of Vietnamese adolescents 13 to 17 years old in San Jose, Calif. METHODS: A purposeful sample of 10 Vietnamese parents with adolescent children were recruited at a Temple in San Jose, Calif. After gaining parental consent and adolescent assent, Vietnamese adolescents participated in an audio-taped, 20 to 30 minute, individual, semi-structured interview in English to explore their perceptions about oral health. Interview data were transcribed verbatim. All statements related to each question were identified, and similar statements were grouped into categories. RESULTS: Ten adolescents participated in the study. All reported tooth appearance as the most important reason for oral care, and that oral health, diet and general health were related. All were concerned about dental pain. Of the respondents, 9 believed that having good teeth would give them more confidence, and help them find jobs and romantic partners, while 2 did not follow recommended oral hygiene routines or recognize early signs of disease. Seven participants favored U.S. dentists over Vietnamese dentists. Frequently reported barriers to seeking dental care were fear of dental treatment (n=7) and inability to pay for dental care (n=6). CONCLUSION: When educating Vietnamese adolescents, dental hygienists need to highlight availability of pain control, encourage better performance of personal oral hygiene and recommend dental clinics with sliding fee scales to low-income families. This approach to oral health education may enhance dental health and seeking of regular dental visits.

Emergence to the conscious state during inpatient rehabilitation after traumatic brain injury in children and young adults: a case series.

OBJECTIVE: To describe clinical patterns related to emergence to the conscious state (CS) in children and young adults with traumatic brain injury receiving acute inpatient rehabilitation. SETTING: One academically affiliated pediatric brain injury rehabilitation unit. PARTICIPANTS: Fourteen consecutive patients aged 1 to 20 years with traumatic brain injury and disorders of consciousness. DESIGN: Retrospective case series. MAIN MEASURES: The primary outcome was emergence to CS during the inpatient rehabilitation admission. Factors evaluated for relationship to emergence to CS included age at injury, admission level of consciousness, admission Rappaport Coma/Near-Coma Scale score, and admission Cognitive and Linguistic Scale responsiveness item score. RESULTS: Ten of 14 patients emerged to CS during the inpatient rehabilitation admission. Those who emerged to CS had higher levels of responsiveness at admission to rehabilitation. There was a trend toward older age in those who emerged to CS. CONCLUSIONS: In this limited cohort, the majority of patients with disorders of consciousness after traumatic brain injury emerged to CS during acute inpatient rehabilitation, underscoring the presence of functional goals for inpatient rehabilitation in this population. Larger cohorts are needed to further explore clinical variables associated with emergence to CS.