Gerilynn Connors, BS, RRT, FAARC
Inova Fairfax Hospital
Falls Church, VA
Arianna Villa, BS, RRT
University of California San Diego
San Diego, CA
AARC Congress 2014 will be held at the Mandalay Bay Resort and Convention Center in Las Vegas Dec. 9-12. Don’t miss the wealth of information presented by experts in the field!
Some highlights pertinent to our section include:
Tuesday, Dec. 9
Symposium: Pulmonary Rehabilitation Best Practices, 1:00-4:55 p.m.
Program Essentials, Patient Education and Training, presented by Connie Paladenech, RRT
Candidate Selection and the Individualized Treatment Plan, Successful Billing and Documentation Processes, presented by Gerilynn Connors, RRT, FAARC, MAACVPR
The COPD Foundation and PR, presented by Scott Cerreta, RRT
Bringing It All Together: Outcomes, Marketing, and Community, presented by Carl Willoughby, RRT
Wednesday, Dec, 10
Pulmonary Rehabilitation: The New Guidelines, presented by Brian Carlin, MD, FAARC
Thursday, Dec. 11
Symposium: Best Practices in Pulmonary Rehabilitation, 10:30 a.m.-12:25 p.m.
Endurance Training and Exercise, presented by Chris Garvey, FNP, MSN, MPA, FAACVPR
Keeping Patients Oxygenated During Exercise Training Sessions, presented by Trina Limberg, RRT, FAARC, MAACVPR
Exercise Training and Progression Case Studies, presented by Carl Willoughby, RRT
Outcomes in Pulmonary Rehabilitation: The Science and Best Practices, 2:25-5:00 p.m.
AACVPR Outpatient Program Registry: It’s All about Benchmarking and Outcomes and Dyspnea Measurements and Psychosocial Evaluations, presented by Chris Garvey, FNP, MSN, MPA, FAACVPR
Quality of Life, Clinical and Sleep Evaluation Tools, presented by Connie Paladenech, RRT
The AACVPR Pulmonary Rehabilitation Program Certification, presented by Gerilynn Connors, RRT, FAARC, MAACVPR
Friday, Dec. 12
Positioning the Respiratory Therapist as a Disease Manager: Now Is the Time, presented by Thomas Kallstrom, MBA, RRT, FAARC
What Every Therapist Needs to Know about End of Life Conversations, presented by Deborah Linehan, RRT
The updated American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) Clinical Competency Guidelines for Pulmonary Rehabilitation Professionals were recently published in the organization’s journal, the Journal of Cardiopulmonary Rehabilitation and Prevention. An update of the guidelines published in 2007, the latest version can be described as a much more in-depth and specific document providing further discussion of the competencies outlined in 2007 while adding others.
The 2007 guidelines focused on three major areas of competency: 1) Assessment, 2) Intervention, and 3) Outcome Evaluation and Follow-up. These major areas were then applied to the topics of pathophysiology and co-morbidity, professional communication, patient education and training, exercise, and psychosocial needs.
The updated guidelines are organized somewhat differently in that they focus on 13 areas of competency with specific areas of knowledge and corresponding skill/ability listed under each area of competency. Some of the newer inclusions/highlights are as follows:
Patient Assessment and Management: Though not a new area of competency by any means, this area was expanded to include a knowledge of current reimbursement criteria for PR and a deeper understanding of the individual patient’s level of readiness for behavior change, cultural framework, and expectations for treatment.
Dyspnea Assessment and Management: Previously included as part of patient assessment, the updated guidelines present dyspnea assessment and management as an independent area of competency and suggest that practitioners possess a better understanding of the various factors contributing to the experience of dyspnea. This includes domains of dyspnea measurement, measurement tools, common descriptors of dyspnea quality, and dyspnea treatment options, including cognitive behavioral therapy.
Oxygen Assessment, Management, and Titration: This is a new area of competency. While surely mentioned in the previous guidelines as an important factor in treatment, the update includes greater detail in many areas of knowledge as well as skills/abilities in oxygen assessment and management. Some examples include limitations and use of pulse oximetry, ABG interpretation, criteria for prescribing LTOT, oxygen devices, developing a prescription, and seeking recommendations for sleep oxygen.
Collaborative Self-Management: This area offers an expanded focus on the elements of self-efficacy and behavior change as well as end of life discussions and advance directives, including palliative and hospice care.
Adherence: Understanding of the elements of pulmonary rehabilitation intervention and identification of barriers to learning as well as adherence to the intervention are featured in this section. Newer additions to this area include weight-loss and weight-gain strategies.
Medication/Therapeutics: Emphasis here is on understanding the types of medication used for diseases other than COPD, as well as the indications/contraindications/side effects of each medication type. Secretion clearance techniques are also listed as an area of knowledge.
Diseases Not Related to COPD: This too is a new area of competency, to include knowledge of lung diseases and patient populations such as asthma, cystic fibrosis/bronchiectasis, lung transplantation, pulmonary hypertension, and lung cancer. Skills/abilities include ability to vary PR to treat these patients.
Exercise Testing: This section specifically emphasizes knowledge/proficiency in performing the 6MWT and shuttle walk test.
Exercise Training: Expanded emphasis on function and activities of daily living and the incorporation of this knowledge into the exercise prescription are highlighted in this section, along with inclusion of the ABG into formulation of an exercise plan when considering patient precautions/limitations. This area also includes functional tests for gait and balance to ensure safety.
Psychosocial Management: Not a new area of competency, but again a much expanded list of suggested knowledge and skills. These include the evaluation of socioeconomic factors, emotional distress, and social relationships and their impact on the PR intervention. This area also suggests the skill/ability to perform individual and group therapy to address stress management and coping strategies.
Tobacco Cessation: The expanded emphasis here includes knowledge of effects, risks, and benefits of pharmacologic agents used to aid tobacco cessation. Also includes skill/ability to perform behavioral interventions to promote tobacco cessation.
Emergency Responses for Patients and Program Personnel: This area has been significantly expanded to include identification and treatment of life-threatening events as well as untoward events. Identification and correct response to changing signs/symptoms is also included along with an understanding of peripheral neuropathy, muscle weakness, inappropriate use of an assistive device, and poor balance. Skill/ability to enact fall prevention plans and correct monitoring of patients is included as well, and it is suggested that all staff participate in mock emergency practice.
Universal Standard Precautions: A new area of competency, this includes knowledge of universal precautions (hand washing, contact, etc.) along with special precautions for treatment of patients with infectious issues as seen in CF and TB. This area also includes suggestions for wiping down equipment and infectious patient vicinity to others.
While it would be impossible to completely cover this new document in an article of this length, I believe you will find the full document to be very informative and invaluable to the PR professional, whether in practice currently, applying for a position in PR, or looking to begin a PR program. Of note, it should be mentioned that the document states that it is unlikely that any onepractitioner is likely to have mastery of all competencies; rather the guidelines should be viewed as a goal to attain within a program staffed by a multidisciplinary team with whatever resources may be available.
Editor’s Note: This article first appeared in the Summer edition of the Long-Term Care Section Bulletin. You may find the information useful when explaining to your patients why it takes so long to bring new respiratory medications to market.
The United States has a long history of working to protect consumers from faulty medications. Attempts to ensure a safe drug supply date back to the early 1800s, when, due to deaths from adulterated smallpox vaccines, Congress passed the Vaccine Act of 1813.
In 1867 the USDA Division of Chemistry began looking into the adulteration of agricultural commodities. The commissioner of agriculture appointed Harvey Washington Wiley as chief chemist; his first role was to investigate the sugar-producing potential of sorghum.
A former chemistry professor and an MD, Dr. Wiley became known for his rigorous scientific procedures, and he branched out from food problems to study useless and adulterated medicines. After several years, he formed a group known as the Poison Squad to look into reports by both citizens and drug companies of dangerous additives and adulteration of medication.
Laws were so ineffective that in 1901, a diphtheria antitoxin was given to 11 children in St. Louis. Of the 11, ten children died. It turned out that the antitoxin was derived from a horse that soon suffered from tetanus and died.
Dr. Wiley became known as the Father of the FDA after the Pure Food and Drug Act was passed by Congress in 1906 and he became the first commissioner. The FDA fought misleading and false claims for years. Of special interest to RTs is the Wil-Hide Exhaler, a device that claimed to cure tuberculosis. This device was widely advertised during World War I.
In 1938 President Roosevelt signed a law mandating that the FDA have authority over premarket reviews of the safety and efficacy of all new drugs and banning false claims as to the efficacy of drugs.
Modern FDA regulations were responsible for alleviating human misery in the 1960s through the FDA’s response to thalidomide, a drug widely prescribed in Europe as a sedative that provided help for women with severe nausea during pregnancy. In 1959, reports started coming into the FDA about babies born with severe birth defects and deformities of their limbs.
Dr. Frances Kelsey, an FDA researcher, found that this drug hadn’t been tested before it was released to the public in Europe and elsewhere. Based on her work, the FDA refused to allow the drug into the U.S. without testing. After this the Kefauver-Harris Act went into effect strengthening the FDA. Pharmaceutical companies had to prove that their drugs were safe and effective. Companies had to monitor safety reports and follow safety standards.
A drug company seeking FDA approval to sell a new prescription drug in the U.S. today must test that drug in different ways to show it is safe and effective. The drug will usually go through four stages of trials. I live in Austin, TX, one of the major centers in the country for phase 2 and 3 clinical trials. Drug companies work with companies that are set up solely to manage drug trials — this includes setting up the trial, finding the subjects, qualifying them, and conducting all aspects of the trial, including payment to the subject. In a clinical trial, participants can be asked to test medical products such as devices and drugs, as well as procedures. The stages or phases of the trials are—
Phase 0: Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (for example, screening studies, microdose studies).
Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug’s most frequent and serious adverse events are, and often, how the drug is metabolized and excreted as well.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages, and by using the drug in combination with other drugs.
Phase 4: Studies occurring after the FDA has approved a drug for marketing. These include postmarket requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug’s safety, efficacy, or optimal use.
It is through these trials that drugs are shown to be safe and effective. It is estimated that it takes five to seven years for a drug or device to be approved. There is some controversy over whether this is too long and should be changed.
Indeed, pharmaceutical companies often complain that it takes too long and costs too much bring new drugs to the marketplace. Patients often feel that it takes too long for them to benefit from the drugs they are anxiously waiting for. I understand both views; however, I wouldn’t want to go back to the days of unregulated and potentially unsafe drugs.
If you are looking for information on a certain drug, go to ClinicalTrials.gov to find out if the medication is in the process of being tested or has been approved.
Attention all budding authors: Got an interesting story? Have an abstract you would like to share? Want to tell a funny story about your program? (Names changed to protect the innocent and HIPAA laws, of course.) Email your contributions to Gerilynn Connors or Arianna Villa by the deadlines stated below.
Bulletin deadlines: Winter Issue: December 1; Spring Issue: March 1; Summer Issue: June 1; Fall Issue: September 1.