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Consensus report. Drug concentrations and driving impairment. Consensus Development Panel.

Most drugs that affect the central nervous system have the potential to impair driving ability. For many years, alcohol (ethanol) has been the drug of greatest concern, since it is, by far, the most frequently recognized cause of drug-impaired driving. Yet as more therapeutic agents, such as benzodiazepines, are introduced and widely used, and as social use of unsanctioned drugs such as cannabis (marijuana) increases, attention must be directed toward other drugs. The National Institute on Drug Abuse sponsored a conference on drugs and driving in Durham, NC, in October 1983. The objective was to reach a consensus on several key issues associated with the current state of knowledge about the relationship between body fluid concentrations of drugs and their pharmacologically active metabolites and degree of driving impairment. It was also of interest to ascertain whether a sufficient body of knowledge exists for an expert to form an opinion, which will meet the applicable standards of proof for legal proceedings, that a person's driving ability was impaired based on body fluid concentrations of a drug. The consensus panel, representing the disciplines of clinical pharmacology, analytical and forensic toxicology, law, and forensic medicine agreed on answers to the following questions: Is ethanol a good model for other drugs? What drugs might have a potential for impairing a driver? How is driving impairment measured? What is known about correlations between driving impairment and drug concentrations? Could "per se" concentrations be established for drugs other than alcohol? Can impairment be established from body fluid concentrations?

Alcohol Drinking↗

European consensus on diagnosis and treatment of germ cell cancer: a report of the European Germ Cell Cancer Consensus Group (EGCCCG).

Germ cell tumour is the most frequent malignant tumour type in young men with a 100% rise in the incidence every 20 years. Despite this, the high sensitivity of germ cell tumours to platinum-based chemotherapy, together with radiation and surgical measures, leads to the high cure rate of > or = 99% in early stages and 90%, 75-80% and 50% in advanced disease with 'good', 'intermediate' and 'poor' prognostic criteria (IGCCCG classification), respectively. The high cure rate in patients with limited metastatic disease allows the reduction of overall treatment load, and therefore less acute and long-term toxicity, e.g. organ sparing surgery for specific cases, reduced dose and treatment volume of irradiation or substitution of node dissection by surveillance or adjuvant chemotherapy according to the presence or absence of vascular invasion. Thus, different treatment options according to prognostic factors including histology, stage and patient factors and possibilities of the treating centre as well may be used to define the treatment strategy which is definitively chosen for an individual patient. However, this strategy of reduction of treatment load as well as the treatment itself require very high expertise of the treating physician with careful management and follow-up and thorough cooperation by the patient as well to maintain the high rate for cure. Treatment decisions must be based on the available evidence which has been the basis for this consensus guideline delivering a clear proposal for diagnostic and treatment measures in each stage of gonadal and extragonadal germ cell tumour and individual clinical situations. Since this guideline is based on the highest evidence level available today, a deviation from these proposals should be a rare and justified exception.

Europe↗

National Institutes of Health Consensus Development Conference Statement: cervical cancer, April 1-3, 1996. National Institutes of Health Consensus Development Panel.

OBJECTIVE: The objective was to provide physicians and the general public with a responsible assessment of current screening, prevention, and treatment approaches to cervical cancer. PARTICIPANTS: A non-Federal, nonadvocate, 13-member panel representing the fields of obstetrics and gynecology, gynecologic oncology, radiation oncology, and epidemiology participated. In addition, 28 experts in obstetrics and gynecology, gynecologic oncology, radiation oncology, gynecologic surgery, and psychology presented data to the panel and a conference audience of 500. EVIDENCE: The literature was searched through Medline, and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. CONCLUSIONS: Carcinoma of the cervix is causally related to infection with the human papillomavirus (HPV). Reducing the rate of HPV infection by changes in sexual behaviors in young people and/or through the development of an effective HPV vaccine would reduce the incidence of this disease. Papanicolaou smear screening remains the best available method of reducing the incidence of and mortality from invasive cervical cancer. Persons with stage IA1 disease have a high cure rate with either simple hysterectomy or, where fertility preservation is an issue, by cone biopsy with clear margins. For patients with other stage I or stage IIA disease, radical surgery or radiation treatment is equally effective. These patients should be carefully selected to receive one treatment or the other but not both, because their combined use substantially increases the cost of and morbidity from treatment. Women with more advanced, nonmetastatic disease should be treated with radiation. Recurrent cervical cancer confined to the pelvis should be treated with the modality not previously received. Radiation therapy is recommended to palliate symptoms in patients with metastatic disease.

Female↗

National Institutes of Health Consensus Development Conference Statement: breast cancer screening for women ages 40-49, January 21-23, 1997. National Institutes of Health Consensus Developmental Panel.

OBJECTIVE: To provide heatlh care providers, patients, and the general public with a responsible assessment of currently available data regarding the effectiveness of mammography screening for women ages 40-49. PARTICIPANTS: A non-Federal, nonadvocate, 12-member panel representing the fields of oncology, radiology, obstetrics and gynecology, geriatrics, public health, and epidemiology and including patient representatives. In addition, 32 experts in oncology, surgical oncology, radiology, public health, and epidemiology, presented data to the panel and to a conference audience of 1,100. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed its conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised draft statement at the end of the conference. The final statement with a minority report was completed within several weeks after the conference. CONCLUSIONS: The Panel concludes that the data currently available do not warrant a universal recommendation for mammography for all women in their forties. Each woman should decide for herself whether to undergo mammography. Her decision may be based not only on an objective analysis of the scientific evidence and consideration of her individual medical history, but also on how she perceives and weighs each potential risk and benefit, the values she places on each, and how she deals with uncertainty. However, it is not sufficient just to advise a woman to make her own decision about mammograms. Given both the importance and the complexity of the issues involved in assessing the evidence, a woman should have access to the best possible relevant information regarding both benefits and risks, presented in an understandable and usable form. Information should be developed for women in their forties regarding potential benefits and risks to be provided to enable each woman to make the most appropriate decision. In addition, educational material to accompany this information should be prepared that will lead women step by step through the process of using such information in the best possible way for reaching a decision. For women in their forties who choose to have mammography performed, the costs of the mammograms should be reimbursed by third-party payors or covered by health maintenance organizations so that financial impediments will not influence a woman's decision. Additionally, a woman's health care provider must be equipped with sufficient information to facilitate her decisionmaking process. Therefore, educational material for physicians should be developed to assist them in providing the guidance and support needed by the women in their care who are making difficult decisions regarding mammography. The two panel members writing a minority report believed the risks of mammography to be overemphasized by the majority and concluded that the data did support a recommendation for mammography screening for all women in this age group and that the survival benefit and diagnosis at an earlier stage outweigh the potential risks.

Adult↗

Report of the American-European consensus conference on ARDS: definitions, mechanisms, relevant outcomes and clinical trial coordination. The Consensus Committee.

The acute respiratory distress syndrome (ARDS), a process of non-hydrostatic pulmonary edema and hypoxemia associated with a variety of etiologies carries a high morbidity, mortality (10-90%) and financial cost. The reported annual incidence in the United States is 150,000 cases, but this figure has been challenged and may be different in Europe. Part of the reason for these uncertainties is the heterogeneity of diseases underlying ARDS and the lack of uniform definitions for ARDS. Thus, those whose wish to know the true incidence and outcome on this clinical syndrome are stymied. The European American Consensus Committee on ARDS was formed to focus on these issues and on the pathophysiologic mechanisms of the process. It was felt that international coordination between North America and Europe in clinical studies of ARDS was becoming increasingly important in order to address the recent plethora of potential therapeutic agents for the prevention and treatment of ARDS.

Clinical Protocols↗

Consensus statement: octreotide dose titration in secretory diarrhea. Diarrhea Management Consensus Development Panel.

Octreotide is an effective therapeutic option in controlling secretory diarrhea of varied etiology. However, marked patient-to-patient differences in the antidiarrheal effects necessitate titration of octreotide dose in individual patients to achieve optimal symptom control. A consensus development panel established guidelines for octreotide dose titration in patients with secretory diarrhea. Overall, the panel recommended an aggressive approach in selecting the initial octreotide dose and in making subsequent dose escalations in patients with secretory diarrhea due to gastrointestinal tumors (eg, carcinoids, VIPomas), AIDS, dumping syndrome, short bowel syndrome, radiotherapy, or chemotherapy. To avoid hypoglycemia in patients with diabetes mellitus-associated secretory diarrhea, the panel recommended a low initial octreotide dose and a conservative titration regimen with close monitoring a blood glucose levels. The end point of therapy should focus on a reduction in diarrhea (frequency of bowel movements or stool volume) rather than normalization of hormonal profile. Overall, octreotide is well tolerated; principal side effects are transient injection site pain and gastrointestinal discomfort. For many patients with secretory diarrhea, octreotide therapy is expected to improve the overall health and quality of life and in the long run will lessen health care costs.

Carcinoid Tumor↗

Report of the American-European Consensus conference on acute respiratory distress syndrome: definitions, mechanisms, relevant outcomes, and clinical trial coordination. Consensus Committee.

The acute respiratory distress syndrome (ARDS), a process of nonhydrostatic pulmonary edema and hypoxemia associated with a variety of etiologies, carries a high morbidity rate, mortality rate (10% to 90%), and financial cost. The reported annual incidence in the United States is 150,000 cases, but this figure has been challenged and may be different in Europe. Part of the reason for these uncertainties is the heterogeneity of diseases underlying ARDS and the lack of uniform definitions for ARDS. Thus, those who wish to know the true incidence and outcome of this clinical syndrome are stymied. The European American Consensus Committee on ARDS was formed to focus on these issues and on the pathophysiologic mechanisms of the process. It was felt that international coordination between North America and Europe in clinical studies of ARDS was becoming increasingly important to address the recent plethora of potential therapeutic agents for the prevention and treatment of ARDS.

Clinical Trials as Topic↗

Canadian consensus recommendations for the measurement and reporting of diastolic dysfunction by echocardiography: from the Investigators of Consensus on Diastolic Dysfunction by Echocardiography.

Abnormalities of diastolic filling are increasingly recognized as a cause of symptoms and predictors of outcome in patients with most forms of heart disease. Noninvasive assessment of diastolic filling is possible in almost all patients, but accurate evaluation must relate echocardiographic Doppler measurements to the complex physiologic and hemodynamic factors responsible for normal and abnormal filling. This evaluation has been facilitated by recent correlation of Doppler measurement of mitral and pulmonary venous inflow with hemodynamic studies. These studies have confirmed that when a careful, integrated approach is taken, Doppler flow patterns can document a progressive pattern of abnormality in many conditions. Impaired left ventricular (LV) relaxation is seen early and is recognized by a decrease in early transmitral LV filling and an increased proportion of filling during atrial contraction. As abnormalities progress, increasing LV chamber stiffness and elevated left atrial pressure lead to a "pseudonormal" filling pattern that previously has caused considerable confusion. This can be unmasked by careful evaluation of pulmonary venous inflow and the use of the Valsalva maneuver. When marked diastolic abnormalities are present, LV filling has restrictive features characterized by rapid early filling, a very stiff left ventricle with high filling pressures, and a poor prognosis. Routine measurement of indexes of diastolic filling have been hampered by uncertainty as to what should be measured, what techniques should be used, definition of normal values, and a clear method of reporting findings. This report represents the efforts of a Canadian consensus group to define a national standard for the performance and reporting of echocardiographic Doppler studies of diastolic filling.

Aged↗

Toward an international consensus on temporomandibular joint surgery. Report of the Second International Consensus Meeting, April 1992, Buenos Aires, Argentina.

This consensus statement reflects the current status of temporomandibular joint surgery in the international community of oral and maxillofacial surgeons in the early 1990s. It is not the end, and it is not the beginning; it is a step forward in the treatment of patients with temporomandibular disorders. It is hoped that this statement will encourage member organizations, and individual members to pursue the issues raised by the proposed criteria. Also there should be continuing debate on the findings presented and on future developments, as well as efforts to teach others the skills the specialty has acquired.

Humans↗

The Consensus Development Program. Detecting changes in medical practice following a consensus conference on the treatment of prostate cancer.

The treatment of prostate cancer was reviewed at a U.S. National Institutes of Health Consensus Development Conference in June 1987. Data from the U.S. National Cancer Institute's Surveillance, Epidemiology, and End Results tumor registries were analyzed and showed that the proportion of eligible prostate cancer patients receiving the recommended therapies did not increase at a faster rate after the conference than before.

Aged↗

Nordic consensus report on asthma management. Nordic Asthma Consensus Group.

The work with the Nordic consensus report on asthma management started some years ago. The Nordic countries have common socioeconomic conditions. We acknowledge the international as well as other European guidelines providing valuable recommendations. Nevertheless, we felt the need to combine the common Nordic experiences in order to have a local statement of asthma and asthma care, based upon Nordic clinical science and tradition. The work has been rewarding and we acknowledge many valuable contributions from paediatricians, allergologists and lung physicians in all Nordic countries. The response has so far been positive and we feel that the present material reflects the main opinion of Nordic physicians taking care of asthma patients of all ages. However, the asthma and allergy research field is rapidly developing. Thus, this document should merely be regarded as a time-limited contribution to the continuing scientific discussion of this fascinating field.

Acute Disease↗

Nutritional assessment and management in cystic fibrosis: a consensus report. The Consensus Committee.

This report is a summary of a meeting convened by the Cystic Fibrosis Foundation to develop a consensus among nutrition specialists and cystic fibrosis care givers regarding optimal nutritional management of patients with cystic fibrosis. The first section of the report provides a rationale for emphasizing nutritional management of this genetic disorder. The multiple factors causing malnutrition and a negative energy balance are outlined. The second section provides guidelines for routine assessment of nutrition in these patients. Five categories of nutritional status are defined based on ideal weight for height, age, and gender. These categories are used to formulate a graded response for nutritional intervention. Recommendations are provided for routine dietary supplements, vitamin supplements, and pancreatic enzyme replacement. The primary aim of this report is to educate clinicians as to the importance of frequent assessments and early intervention.

Cystic Fibrosis↗

National Institutes of Health Consensus Development Conference Statement: Breast Cancer Screening for Women Ages 40-49, January 21-23, 1997. National Institutes of Health Consensus Development Panel.

OBJECTIVE: To provide health care providers, patients, and the general public with a responsible assessment of currently available data regarding the effectiveness of mammography screening for women ages 40-49. PARTICIPANTS: A non-Federal, nonadvocate, 12-member panel representing the fields of oncology, radiology, obstetrics and gynecology, geriatrics, public health, and epidemiology and including patient representatives. In addition, 32 experts in oncology, surgical oncology, radiology, public health, and epidemiology, presented data to the panel and to a conference audience of 1,100. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed its conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised draft statement at the end of the conference. The final statement with a minority report was completed within several weeks after the conference. CONCLUSIONS: The Panel concludes that the data currently available do not warrant a universal recommendation for mammography for all women in their forties. Each woman should decide for herself whether to undergo mammography. Her decision may be based not only on an objective analysis of the scientific evidence and consideration of her individual medical history, but also on how she perceives and weighs each potential risk and benefit, the values she places on each, and how she deals with uncertainty. However, it is not sufficient just to advise a woman to make her own decision about mammograms. Given both the importance and the complexity of the issues involved in assessing the evidence, a woman should have access to the best possible relevant information regarding both benefits and risks, presented in an understandable and usable form. Information should be developed for women in their forties regarding potential benefits and risks to be provided to enable each woman to make the most appropriate decision. In addition, educational material to accompany this information should be prepared that will lead women step by step through the process of using such information in the best possible way for reaching a decision. For women in their forties who choose to have mammography performed, the costs of the mammograms should be reimbursed by third-party payors or covered by health maintenance organizations so that financial impediments will not influence a woman's decision. Additionally, a woman's health care provider must be equipped with sufficient information to facilitate her decisionmaking process. Therefore, educational material for physicians should be developed to assist them in providing the guidance and support needed by the women in their care who are making difficult decisions regarding mammography. The two panel members writing a minority report believed the risks of mammography to be overemphasized by the majority and concluded that the data did support a recommendation for mammography screening for all women in this age group and that the survival benefit and diagnosis at an earlier stage outweigh the potential risks.

Adult↗

The World Health Organization/International Society of Urological Pathology consensus classification of urothelial (transitional cell) neoplasms of the urinary bladder. Bladder Consensus Conference Committee.

This WHO/ISUP system is an attempt to develop as broad a consensus as possible in the classification of urothelial neoplasms, building upon earlier works and classification systems. It is meant to serve as a springboard for future studies that will help refine this classification, thus enabling us to provide better correlation of these lesions with their biologic behavior using uniform terminology.

Carcinoma, Transitional Cell↗

Management of intracardiac device recalls: a consensus conference. Participants of the Consensus Conference. North American Society of Cardiac Pacing and Electrophysiology (NASPE)

The incidence of cardiac device recalls seems to be increasing, in part due to increasing complexity, but also due to greater public awareness and regulatory overview. Manufacturers are responsible for postmarket surveillance of their implanted products; evidence for poor performance is usually evaluated by a Physician Advisory Committee (PAC) and unacceptable failure rates or modes prompt the issuance of a recall. A Consensus Conference was held March 6, 1995, in Toronto, Ontario, to discuss the management of cardiac device recalls after the provincial Ministry of Health issued unique guidelines regarding a recent lead problem. Various stakeholders expressed their views and concerns: the federal regulatory body, the provincial Ministry of Health and hospital association, manufacturers, hospital legal counsel, patient and media advocates, and physicians from the United Kingdom, the United States, and Canada. Specific recommendations included: the establishment of a National (or regional) Pacemaker (device/lead) Registry interposed between the manufacturer and the federal authority; the creation of a Recall Task Force (RTF) to deal with specific problems distinct from the manufacturers' PAC; emphasis on patient responsibility for obtaining regular follow-up and maintaining contact by a pacemaker passport system as exists in Europe; and the fair assignment of costs involved in a recall with specific emphasis on appropriate compensation for physicians and clinic personnel.

Defibrillators, Implantable↗

Neuroprotection as initial therapy in acute stroke. Third Report of an Ad Hoc Consensus Group Meeting. The European Ad Hoc Consensus Group.

Although a considerable body of scientific data is now available on neuroprotection in acute ischaemic stroke, this field is not yet established in clinical practice. At its third meeting, the European Ad Hoc Consensus Group considered the potential for neuroprotection in acute stroke and the practical problems attendant on the existence of a very limited therapeutic window before irreversible brain damage occurs, and came to the following conclusions. NEUROPROTECTANTS IN CLINICAL DEVELOPMENT: Convincing clinical evidence for an efficacious neuroprotective treatment in acute stroke is still required. Caution should be exercised in interpreting and extrapolating experimental results to stroke patients, who are a very heterogeneous group. The limitations of the time windows and the outcome measures chosen in trials of acute stroke therapy have an important influence on the results. The overall distribution of functional outcomes provides more statistical information than the proportion above a threshold outcome value. Neurological outcome should also be assessed. Neuroprotectants should not be tested clinically in phase II or phase III trials in a time window that exceeds those determined in experimental studies. The harmful effects of a drug in humans may override its neuroprotective potential determined in animals. Agents that act at several different levels in the ischaemic cascade may be more effective than those with a single mechanism of action. CURRENT IN-HOSPITAL MANAGEMENT OF ACUTE STROKE: The four major physiological variables that must be monitored and managed are blood pressure, arterial blood gas levels, body temperature, and glycaemia. The effects of controlling these physiological variables have not been studied in prospective trials, though they may all contribute to the outcome of acute ischaemic stroke and affect the duration of the therapeutic window. Optimal physiological parameters are inherently neuroprotective. Trials of new agents for the treatment of acute stroke should aim to maintain these physiological variables as close to normal as possible, and certainly within strictly defined limits. THE PLACE OF NEUROPROTECTANTS IN ACUTE STROKE MANAGEMENT: Stroke patients are a very heterogeneous group with respect to stroke mechanisms and severity, general condition, age and co-morbidities. At the present time, the only firm guideline than can be proposed for patient selection is the need for early admission to enable neuroprotectant and/or thrombolytic treatment to be started as soon as possible within the therapeutic window. The severity of potential side-effects will largely determine who should assess a patient with suspected stroke and initiate treatment. There is little information on which to base the duration of neuroprotectant therapy, and more experimental data are needed. Even if prehospital treatment proves to be feasible, it should not replace comprehensive stroke management in a specialist hospital unit. Clinical trials of neuroprotectants should only be performed in stroke units. The combined approach of restoring blood flow and providing neuroprotection may be the most productive in human stroke, but current clinical trial design will have to change in order to test combination therapy. Important side-effects are those that interfere with any possible benefit or increase mortality. PHARMACO-ECONOMIC ASPECTS OF NEUROPROTECTANTS: The early increase in hospital cost associated with neuroprotectant therapy may be balanced by the shorter length of hospital stay and lesser degree of disability of the surviving patients. The overall direct financial cost is highly dependent on the number of patients eligible for neuroprotectant therapy, which is itself dependent on the length of the therapeutic window and the severity of potential side-effects. A treatment that achieves a good functional outcome is the most cost-effective approach.

Acute Disease↗

A consensus view on the technique of ambulatory blood pressure monitoring. The Fourth International Consensus Conference on 24-Hour Ambulatory Blood Pressure Monitoring.

This review, based on the Fourth International Consensus Conference on Ambulatory Blood Pressure Monitoring (Leuven, Belgium, 1994), deals with the technical aspects of ambulatory blood pressure monitoring. Ambulatory blood pressure monitoring by noninvasive intermittent techniques is widely used despite artifacts due to cuff size, movement, body position, short-term blood pressure variability, and interference with sleep. The performance of the currently available monitors under truly ambulatory conditions and during exercise remains a matter of debate, as are the procedures required to validate portable monitors under these circumstances. There is general agreement that whenever a monitor is to be used in special populations, such as older subjects or pregnant women, or in special conditions, such as exercise, a specific demonstration of its accuracy in these defined subgroups or conditions is warranted. Whether the auscultatory or oscillometric method is preferred remains controversial because each technique has specific advantages and disadvantages and because both can provide accurate results. Most experts in the field strongly believe that manufacturers should disclose the algorithms of their devices and that they should specify all changes made to the hardware and software of a previously validated monitor. Finally, the development of the volume-clamp method, which makes continuous noninvasive registration of blood pressure at the finger possible in both stationary and ambulatory conditions, opens new perspectives in research, in particular in relation to short-term blood pressure variability.

Adult↗

A consensus-based approach to providing palliative care to patients who lack decision-making capacity. ACP-ASIM End-of-Life Care Consensus Panel. American College of Physicians-American Society of Internal Medicine.

Making palliative care decisions for a patient who lacks decision-making capacity presents several challenges. Other people, such as family and caregivers, must choose for the patient. The goals and values of these decision makers may conflict with those of each other and with those of the patient, who now lacks the capacity to participate in the decision. This paper presents a case study of a patient with severe Alzheimer disease who has two common clinical problems: neurogenic dysphagia and aspiration pneumonia. The case study describes a consensus-based decision-making strategy that keeps what is known about the patient's wishes and values in the foreground but also expects guidance from the physician and elicits input from family members and other people who care for and have knowledge about the patient. The steps of this process, including key clinical prompts and potential transition statements, are outlined and described. The overall goal of the case commentary is to demonstrate that physicians can guide a highly emotional and personal process in a structured manner that has meaning for the patient, family, physician, and other caregivers.

Advance Care Planning↗