Outcomes of Below-the-Knee Amputations for Chronic Lower Extremity Pain.

The study evaluated the physical,mental, and functional outcomes following below-the-knee amputation (BKA) for management of chronic, debilitating lower extremity pain. The hypothesis was that patients who undergo a BKA to alleviate chronic pain achieve a greater level of function, experience decreased pain, and benefit from improved health-related quality of life. Patients who received a BKA attended an orthopaedic clinic and completed questionnaires examining their overall health, functional status, mental health, and pain. Thirty-seven patients were identified as eligible for study participation; 15 agreed to participate. Although most participants continued to experience pain in their residual limb after BKA, they reported their pain decreased to a manageable level. Participants experienced a statistically significant improvement in their perceived physical health. The authors believe a BKA for chronic pain is a reasonable treatment option for patients who continue to experience lower extremity pain after failed medical and surgical management of chronic pain. (Journal of Surgical Orthopaedic Advances 26(4):200-205, 2017).

Intervening at the Setting Level to Prevent Behavioral Incidents in Residential Child Care: Efficacy of the CARE Program Model.

The current study examined the impact of a setting-level intervention on the prevention of aggressive or dangerous behavioral incidents involving youth living in group care environments. Eleven group care agencies implemented Children and Residential Experiences (CARE), a principle-based program that helps agencies use a set of evidence-informed principles to guide programming and enrich the relational dynamics throughout the agency. All agencies served mostly youth referred from child welfare. The 3-year implementation of CARE involved intensive agency-wide training and on-site consultation to agency leaders and managers around supporting and facilitating day-to-day application of the principles in both childcare and staff management arenas. Agencies provided data over 48 months on the monthly frequency of behavioral incidents most related to program objectives. Using multiple baseline interrupted time series analysis to assess program effects, we tested whether trends during the program implementation period declined significantly compared to the 12 months before implementation. Results showed significant program effects on incidents involving youth aggression toward adult staff, property destruction, and running away. Effects on aggression toward peers and self-harm were also found but were less consistent. Staff ratings of positive organizational social context (OSC) predicted fewer incidents, but there was no clear relationship between OSC and observed program effects. Findings support the potential efficacy of the CARE model and illustrate that intervening "upstream" at the setting level may help to prevent coercive caregiving patterns and increase opportunities for healthy social interactions.

PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients.

INTRODUCTION: Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. The primary aim of this trial is to compare aspirin with LMWH as a thromboprophylaxis in fracture patients. METHODS AND ANALYSIS: PREVENT CLOT is a multicentre, randomised, pragmatic trial that aims to enrol 12 200 adult patients admitted to 1 of 21 participating centres with an operative extremity fracture, or any pelvis or acetabular fracture. The primary outcome is all-cause mortality. We will evaluate non-inferiority by testing whether the intention-to-treat difference in the probability of dying within 90 days of randomisation between aspirin and LMWH is less than our non-inferiority margin of 0.75%. Secondary efficacy outcomes include cause-specific mortality, non-fatal PE and deep vein thrombosis. Safety outcomes include bleeding complications, wound complications and deep surgical site infections. ETHICS AND DISSEMINATION: The PREVENT CLOT trial has been approved by the ethics board at the coordinating centre (Johns Hopkins Bloomberg School of Public Health) and all participating sites. Recruitment began in April 2017 and will continue through 2021. As both study medications are currently in clinical use for VTE prophylaxis for orthopaedic trauma patients, the findings of this trial can be easily adopted into clinical practice. The results of this large, patient-centred pragmatic trial will help guide treatment choices to prevent VTE in fracture patients. TRIAL REGISTRATION NUMBER: NCT02984384.

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials.

INTRODUCTION: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. METHODS: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. RESULTS: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. DISCUSSION: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

Children and residential experiences: a comprehensive strategy for implementing a research-informed program model for residential care.

This paper describes an effort to bridge research and practice in residential care through implementing a program model titled Children and Residential Experiences (CARE). The strategy involves consulting at all levels of the organization to guide personnel to incorporate CARE evidence-based principles into daily practice, and fostering an organizational culture and climate that sustains the integration of CARE principles. CARE aims to promote residential care programs that serve the best interests of children.

Post-traumatic ulnar artery thrombosis: outcome of arterial reconstruction using reverse interpositional vein grafting at 2 years minimum follow-up.

PURPOSE: Treatment of posttraumatic symptomatic ulnar artery thrombosis (UAT) is controversial. This study reports the outcome at 2 years minimum follow-up of a uniform approach using reversed interpositional vein grafting to treat symptomatic patients with UAT. METHODS: The records of all patients with vascular disease of the upper extremity who were revascularized at the authors' institution were retrospectively reviewed, and the following inclusion criteria were applied: (1) arteriographically proven UAT treated with excision of the involved segment and reversed interpositional vein grafting; (2) absence of collagen vascular disease, coagulopathy, or peripheral vascular disease, (3) minimum follow-up of 24 months. Twelve patients (13 hands) were identified and evaluated before surgery and at final follow-up using the following health-related quality of life outcome instruments: (1) McCabe cold sensitivity severity scale, (2) McGill visual analog pain scale, (3) Levine symptom and function scale, and (4) Wake Forest University symptom scale (pain, numbness, and cold intolerance). Digital microvascular perfusion testing (laser Doppler perfusion imaging and isolated cold stress testing) was also performed, and the final test was compared with 28 normal controls. All patients were evaluated for graft patency as determined by Allen's testing and/or Doppler ultrasound. RESULTS: Ten of the 13 grafts were patent at final follow-up (77% patency rate). In all the patients with patent grafts, the Levine symptom scale, the McGill visual analog pain scale, the McCabe cold sensitivity severity scale, and the isolated cold stress testing responses of the patients were significantly improved at final follow-up. Isolated cold stress testing responses were not different from those of normal controls. The changes in the Levine function scale, Wake Forest University scale, and laser Doppler perfusion imaging were not significant. In the nonpatent grafts (3 of 13), 2 patients still complained of pain, numbness, and cold sensitivity, whereas 1 patient has minimal symptoms and continues to improve. CONCLUSIONS: Successful arterial reconstruction in symptomatic posttraumatic UAT decreases symptoms, improves function and microvascular physiology, and has a positive effect on the health-related quality of life. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

[Therapeutic Residential Care for Children and Youth: A Consensus Statement of the International Work Group on Therapeutic Residential Care].

Therapeutic Residential Care for Children and Youth: A Consensus Statement of the International Work Group on Therapeutic Residential Care. In many developed countries around the world residential care interventions for children and adolescents have come under increasing scrutiny. Against this background an international summit was organised in England (spring 2016) with experts from 13 countries to reflect on therapeutic residential care (TRC). The following working definition of TRC was leading: “Therapeutic residential care involves the planful use of a purposefully constructed, multi-dimensional living environment designed to enhance or provide treatment, education, socialization, support, and protection to children and youth with identified mental health or behavioral needs in partnership with their families and in collaboration with a full spectrum of community based formal and informal helping resources”. The meeting was characterised by exchange of information and evidence, and by preparing an international research agenda. In addition, the outlines of a consensus statement on TRC were discussed. This statement, originally published in English and now reproduced in a Spanish translation, comprises inter alia five basic principles of care that according to the Work Group on Therapeutic Residental Care should be guiding for residential youth care provided at any time.

Learning from tragedy: a survey of child and adolescent restraint fatalities.

OBJECTIVE: This descriptive study examines 45 child and adolescent fatalities related to restraints in residential (institutional) placements in the United States from 1993 to 2003. METHOD: The study team used common Internet search engines as its primary case discovery strategy to determine the frequency and the nature of the fatalities, as well as the characteristics of the children and the adolescents involved. RESULTS: Male children and adolescents were over-represented in the study sample. Thirty-eight of the fatalities occurred during or after a physical restraint, and 7 fatalities occurred during the use of mechanical restraints. Twenty-eight of the deaths occurred in a prone restraint. In 25 of the fatalities, asphyxia was the cause of death. CONCLUSION: In the 23 cases in this study where information is available, none of the child behaviors or conditions that prompted the restraint would meet the standard of danger to self or others: the commonly accepted criteria for the use of a restraint. The study points to deficiencies in fatality reporting, recommends reporting fatalities to established state child fatality review boards, and reinforces that restraints be governed by strict protocol and monitoring. The study also urges caution to policymakers in substituting or changing restraint procedures based on the incomplete data reported in this study.

Analysis of outcomes of anterior cruciate ligament repair with 5-year follow-up: allograft versus autograft.

PURPOSE: To prospectively compare outcomes of primary anterior cruciate ligament (ACL) reconstruction with either Achilles tendon allograft with soft-tissue fixation or standard bone-patellar tendon-bone autograft with interference screw fixation. TYPE OF STUDY: Prospective comparative case series. METHODS: A group of 41 patients who underwent soft-tissue allograft reconstruction and a group of 118 patients who underwent autograft bone-patellar tendon-bone reconstruction were included in the final results. Patients were evaluated preoperatively and postoperatively at 1 to 2 weeks, 6 weeks, 3 months, 6 months, and then annually for 5 years. Objective measures of outcome included KT-1000 measurements, range of motion, ligamentous integrity, thigh atrophy, and International Knee Documentation Committee score. Subjective evaluations included patient completion of 5 questionnaires documenting functional status, pain, and health-related quality of life: (1) the short-form McGill Pain Questionnaire, (2) a patient subjective assessment of knee function and symptoms, (3) a patient subjective assessment follow-up, (4) a knee pain scale, and (5) the RAND 36-Item Health Survey. Mixed models analysis of variance was used to compare the outcomes of the treatment groups using baseline values of the study variables as a covariate. RESULTS: Autograft patients reported significantly more pain on the bodily pain subscale of the RAND-36 than the allograft group at 1 week (P = .0006), 6 weeks (P = .0007), and 3 months (P = .0270). Autograft patients reported more pain than allograft patients on the McGill Pain Scale visual analog scale at 1 to 2 weeks (P < .0001) and 6 weeks (P = .0147). Patient assessment of function and symptoms showed that a higher proportion of patients reported normal or nearly normal knee function in the allograft group than in the autograft group at 3 months (33% v 14%, P = .0558, respectively). Fewer activity limitations were reported by allograft patients than autograft patients at 6 weeks (P = .0501), 3 months (P = .0431), and 6 months (P = .0014). After reconstruction, the allograft group displayed significantly more laxity in KT-1000 measurements at all time points than the autograft group (P = .0520). These measurements decreased over time for both groups (P < .0001). CONCLUSIONS: Five-year follow-up of patients undergoing ACL reconstruction with allograft versus autograft were compared objectively and subjectively. Both groups of patients achieved similar long-term outcomes. Overall, the allograft patients reported less pain at 1 and 6 weeks after surgery, better function at 1 week, 3 months, and 1 year, and fewer activity limitations throughout the follow-up period. LEVEL OF EVIDENCE: Level II, prospective cohort study.

Periarterial sympathectomy of the foot for the treatment of necrotizing Raynaud's phenomena.

Patients with critical peripheral vascular disease and nonhealing toe ulcers secondary to collagen vascular disease often require toe amputation when nonsurgical measures fail to control their symptoms. The aim of this study was to evaluate the effectiveness of periarterial sympathectomy (PAS) of the foot/ankle in patients with unreconstructable vaso-occlusive disease and nonhealing digit ulcers unresponsive to nonsurgical measures. Five patients (seven feet and nine toe ulcers) were treated with PAS of their involved foot and followed for a minimal of 3 years (3 to 7 years). The technique included PAS of the dorsalis pedis, posterior tibial and anterior tibial arteries. Eight toe ulcers healed uneventfully within 3 months after surgery. Only one patient developed a new ulcer 5 years after PAS. The mean visual analog pain scale improved from 5.7 to 1 (P<0.03). The mean Wake Forest University (WFU) scale improved from 1.8 to 0.5 (P=0.07). There was no change in the WFU numbness score or the McCabe Cold sensitivity scale. The results suggest that foot/ankle PAS is a beneficial salvage treatment option for patients with non-reconstructable, vaso-occlusive disease that ameliorates foot symptoms, facilitates healing of toe ulcerations, and reduces the incidence of toe amputations.

Periarterial sympathectomy in scleroderma patients: intermediate-term follow-up.

The use of periarterial sympathectomy (PAS) to manage chronic digital ischemia caused by scleroderma remains controversial. The duration of efficacy of PAS in managing scleroderma symptoms was evaluated by examining microvascular physiology, health-related quality of life, and patient satisfaction. Twenty-two patients (29 hands) with scleroderma, chronic vascular insufficiency, and a history of nonhealing digital ulcers unresponsive to nonsurgical treatment were evaluated. Isolated cold stress testing and laser Doppler fluxmetry measurements were used to evaluate microvascular perfusion before surgery and after a mean follow-up period of 31 months (range, 7-108 months). Digital temperatures did not change after surgery, but microvascular perfusion had increased significantly at a mean of 31 months in 22 hands. Health-related quality-of-life data were collected at a mean of 46 months (range, 11-108 months) after surgery. Subjective improvement (fewer ulcers, faster ulcer healing, and decreased pain) was reported for 18 of 22 patients (24 of 29 hands) at a mean follow-up period of 46 months; 6 patients remained ulcer free. Follow-up of scleroderma patients after PAS documented improved microvascular perfusion as evaluated by laser Doppler fluxmetry and by variable clinical results.

The acute effect of peripheral nerve transection on digital thermoregulatory function.

PURPOSE: This study tests the hypothesis that major peripheral nerves serve as important routes for adrenergic neural fibers and therefore peripheral nerve injury affects cutaneous perfusion within the nerve's sensory innervation territory. The specific aim of the study was to determine whether an acute isolated peripheral nerve injury would result in alteration of blood flow to a specific digit, digital pain, and/or cold sensitivity. METHODS: The influence of peripheral nerves on their dominant area of autonomic vasomotor function was evaluated in 9 patients who had primary neurorrhaphy after a single complete median or ulnar nerve transection. At a mean follow-up of 47 days the response of digital perfusion to a cold stress was examined in these patients by using isolated cold stress testing and laser Doppler fluxmetry. Patients also completed subjective questionnaires to evaluate their symptoms. RESULTS: The affected hands showed a decreased cutaneous perfusion when compared with the contralateral hands during all 3 phases of the cold stress test. In addition cutaneous perfusion patterns evaluated by laser Doppler perfusion imaging showed markedly decreased cutaneous perfusion patterns in the digits within the innervation territory of the injured nerve. There was no notable difference in digital baseline temperatures and temperature changes after an isolated cold stress test between the most affected digits of the injured hands and corresponding digits of the unaffected, contralateral hands. All 9 patients reported mild to severe digital numbness, 8 reported mild to severe pain, and 4 reported mild to moderate cold sensitivity of the upper extremity. CONCLUSIONS: This study documents that cutaneous perfusion and thermoregulatory function is altered after isolated peripheral nerve injury.