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Patients may suffer systemic effects from cold (hypothermia) or localized effects. Patients with mild hypothermia will have normal mental status, shivering, and may have normal vital signs while patients with moderate to severe hypothermia will manifest mental status changes, eventual loss of shivering and progressive bradycardia, hypotension, and decreased respiratory status 4. Patients with cold exposure but no symptoms referable to hypothermia or frostbite Patient Management Assessment 1. Patient assessment should begin with attention to the primary survey, looking for evidence of circulatory collapse and ensuring effective respirations a. The patient suffering from moderate or severe hypothermia may have severe alterations in vital signs including weak and extremely slow pulses, profound hypotension and decreased respirations b. The rescuer may need to evaluate the hypothermic patient for longer than the normothermic patient (up to 60 seconds) 298 3. Mild: vital signs not depressed normal mental status, shivering is preserved; body maintains ability to control temperature b. Maintain patient and rescuer safety the patient has fallen victim to cold injury and rescuers have likely had to enter the same environment. Remove the patient from the environment and prevent further heat loss by removing wet clothes and drying skin, insulate from the ground, shelter the patient from wind and wet conditions, and insulate the patient with dry clothing or a hypothermia wrap/ blanket. Cover the patient with a vapor barrier and, if available, move the patient to a warm environment b. Hypothermic patients have decreased oxygen needs and may not require supplemental oxygen i. Provide beverages or foods containing glucose if feasible and patient is awake and able to manage airway independently d. Vigorous shivering can substantially increase heat production shivering should be fueled by caloric replacement. Monitor frequently if temperature or level of consciousness decreases, refer to Severe Hypothermia, below g. The recommended fluid for volume replacement in the hypothermic patient is normal saline h.

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In an ethical sense, the agreement by a patient to receive public sector health services reflects the end point of a process of engagement in which one or more health practitioners have supported the patient to come to an informed decision to agree to the health care offered. End-of-life care: Guidelines for decision-making about withholding and withdrawing January 2018 31 life-sustaining measures from adult patients clearly understand the information because it is provided in a language or by other means the patient can understand as far as possible, the patient is advised in simple terms of: the diagnosis recommended health care, including the expected benefits, common side effects and alternative health care options the material risks including complications associated with: the recommended health care alternative health care options a decision not to receive the health care offered any significant long term physical, emotional, mental, social, sexual or other expected outcomes the anticipated recovery implications the patient has sufficient time to consider and clarify information in order to make an informed decision, taking into account the context of the clinical situation the information provided and the consent given relate to the specific health care provided. There are tensions between what constitutes informed consent for providing medical treatment versus the refusal of medical treatment. Some patients may be competent to consent to minor procedures like vaccinations but not competent to consent to major surgery or the prospect of life-sustaining measures being withheld or withdrawn. Such dilemmas not only create doubt in the process of assessing capacity, it adds to the pressure on doctors making assessments to ensure the patient (and his or her substitute decision-maker) has sufficient information to make an informed decision. A patient needs to know what options are available, what the expected outcomes are for each option, and what the success rates and incidence of side-effects are for each option. The treating doctor and attending healthcare team need to know that the patient understands the implications of their decision. To add to the complexity of issues in applying informed consent principles in this area, some consent can be verbal or implied, and consent need not be in writing to be enforceable. It should be pointed out that the signature on a consent form is not considered to be enough to show the consent is valid and informed. This is connected to the fundamental right of an adult with decisional capacity to refuse medical treatment even if this results in their death or would cause it to happen sooner. End-of-life care: Guidelines for decision-making about withholding and withdrawing January 2018 32 life-sustaining measures from adult patients However, it is important to note that informed consent provisions apply when decisions are made by a substitute decision-maker at the time that health or medical treatment is required, in the same way as they apply when a competent adult decides whether or not to undergo treatment. The treating health care team is obliged to give the substitute decision-maker sufficient information to make that decision in an informed manner. This is to ensure the decision is based on accurate information and not on any misunderstanding or misinterpretation of the facts. In these instances, there is a careful balance between pressuring the patient into something they do not wish and ensuring the information provided to the patient is consistent with good medical practice. If those closest to the patient are involved in these discussions, care must also be taken to ensure the wishes and views of the patient, rather than their family, are followed.

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Irwin K, Henderson D, Knight H, Pirl W Cancer care for individuals with schizophrenia Cancer 2013;120(3):323-334. Kiely D, Prigerson H, Mitchell S Health care proxy grief symptoms before the death of nursing home residents with advanced dementia Am J Geriatr Psychiatry. Le T, Najolia G, Minor K, Cohen A the effect of limited cognitive resources on communication disturbances in serious mental illness Psychiatry Res 2017;248:98-104 doi:10 1016/j psychres 2016 12 025 Sacco P, Cagle J, Moreland M, Camlin E Screening and assessment of substance use in hospice care: Examining content from a national sample of psychosocial assessments J Palliat Med. Domain 4: Social Aspects of Care Adames H, Chavez-Duenas N, Fuentes M, Salas S, Perez-Chavez J Integration of Latino/a cultural values into palliative health care: A culture centered model Palliat Sup Care. Communication patterns associated with physician discussion of patient expressions of negative emotion in hospital admission encounters Patient Educ Couns. Allen R, Hilgeman M, Ege M, Shuster J, Burgio L Legacy activities as interventions of approaching the end of life J Palliat Med. Altilio T, Gardia G, Otis-Green S Social work practice in palliative and end of life care J Soc Work End Life Palliat Care. Bern-Klug M A framework for categorizing social interactions related to end-of-life care in nursing homes Gerontologist. Brand S, Fasciano K, Mack J Communication preferences of pediatric cancer patients: talking about prognosis and their future life Support Care Cancer. Cagle J, Bunting M Patient reluctance to discuss pain: Understanding stoicism, stigma, and other contributing factors J Soc Work End Life Palliat Care. Chandran D, Corbin J, Shillam C An ecological understanding of caregiver experiences in palliative care J Soc Work End Life Palliat Care. Dougherty C, Pyper G, Au D, Levy W, Sullivan M Drifting in a shrinking future J Cardiovasc Nurs 2007;22(6):480-487. Hansen L, Rosenkranz S, Mularski R, Leo M Family perspectives on overall care in the intensive care unit Nurs Res. Haxton J, Boelk A Serving families on the frontline: Challenges and creative solutions in rural hospice social work Soc Work Health Care. Hebert R, Copeland V, Schulz R, Amato C, Arnold R Preparing family caregivers for the death of a loved one: Implications for hospital social workers J Soc Work End Life Palliat Care. Reframing, refocusing, referring, reconciling, and refecting: Exploring confict resolution strategies in end-of-life situations Health Commun.

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However, the applicant notes that healing of the displaced fractures was observed in a subset of patients. Table 27: Fracture Healing in Subjects with Displaced and Non-displaced Fractures Displaced Fractures Non-Displaced Fractures Device % of % Healed % of % Healed n n Fractures by 24M Fractures by 24M Superion 23. Additional treatments were also assessed for subjects with and without spinous process fractures (Table 29). These data demonstrate that subjects observed to have a spinous process fracture by the independent radiographic lab required an additional treatment at a lower rate than study subjects without spinous fractures. These results, coupled with the clinical outcomes presented in Table 28, suggest that some of these spinous process fractures may have been asymptomatic. Neurologic Status Outcomes Neurologic success was defined as maintenance or improvement in neurological status as assessed by motor, sensory and deep tendon reflex examination. Effectiveness Results the analysis of effectiveness was based on the 391 evaluable subjects at the 24-month time point. Implant-and Procedure-Related Complications For the component of dislodgement, migration or deformation, 24 of the 201 (11. Clinically Significant Confounding Treatments Following index surgery, 0 of the 190 (0. No subject in either group received a spinal cord stimulator at the level(s) of surgery prior to Month 24. Even when investigating each demographic population, no substantial trends could be found that would demonstrate greater effectiveness of one device over the other. In particular, the improvement in leg pain may be significant to patients and their treating physicians as this symptom is a component of intermittent neurogenic claudication. The data does not, however, demonstrate that this improvement in pain and function is maintained with motion and walking. The applicant states that the investigational device functions by extension blockage; however, data separating flexion from extension was not captured in the study, thus the data is not clear in determining if this was achieved. There is minimal change in translational motion over time in either treatment group, and the applicant characterizes the data as maintenance of motion. In other words, the natural lordosis present at the pre-operative evaluation decreases when the spinous process distance increases. Anterior disc height changes from the pre-operative measurements at the index level are nominally different at 6 weeks through 18 months in both treatment groups. The quantitative posterior disc height data is presented below in Table 42 Posterior disc height increases following surgery in both treatment groups. At 24 months, the mean posterior disc height is lower than the pre operative measurements. In both groups, there is an immediate increase in the post-op measurements, followed by a slight decrease that can be attributed to patient mobility and device settling. At 24 months, the spinous process distance is greater than the pre-operative condition for both groups.