About Amyotrophic Lateral Sclerosis (ALS)
What is Amyotrophic Lateral Sclerosis?
Amyotrophic Lateral Sclerosis (ALS) often referred to as “Lou Gehrig’s Disease” or Motor Neuron Disease, is a progressive, fatal neuromuscular disease. It causes degeneration of motor nerve cells in the brain and the spinal cord, leading to muscle weakness. As the disease progresses, total paralysis and an inability to speak or swallow can result. There is no known cause or cure for the disease.
What environmental concerns have been reported in the scientific literature in relation to ALS?
Exposures to elements found in the environment, such as lead, mercury, and cyanobacteria, have been investigated for concerns in causing or increasing one’s risk in developing ALS. Studies finding an increased risk of ALS suggest that more research is needed to accurately assess causal links to any exposure.
ALS Registry of Massachusetts
What is the Massachusetts ALS Registry?
The Massachusetts ALS Registry is a population based surveillance system that identifies statewide ALS cases. Patients are identified by neurologists, hospitals, nursing homes, hospices, and death certificates. The registry contains basic patient demographics (age, gender, and address), and diagnosis information.
Why is the Massachusetts Department of Public Health (MDPH) tracking ALS?
In 2002, Massachusetts was one of seven states awarded funds by the U.S. Centers for Disease Control and Prevention to track health conditions thought to be impacted by the environment. The statewide registry, initially supported by these funds, was established in 2003 in accordance with legislation supported by ALS patients and advocacy groups calling for more research into the causes of ALS.
The Massachusetts ALS Registry is used to determine the prevalence of disease and the frequency of new cases in Massachusetts. This information allows MDPH to compare state rates to those found in other places, to evaluate trends over time, and to identify the geographic patterns of ALS across the state. Additionally, a registry can help public health and other researchers investigate causes of ALS and advance research for treatments.
Is the Massachusetts ALS Registry the same as the National ALS Registry?
No, the National ALS Registry is a separate and voluntary registry created to identify and gather information about ALS from cases throughout the United States. Unlike the MA ALS Registry which automatically registers all ALS cases who are residents of Massachusetts as a result of the mandated reporting, persons with ALS must register to become a part of the National ALS Registry. While the two are not directly associated, both provide important and unique opportunities to add to the current knowledge of ALS occurrence. Patients are encouraged to register through the National ALS Registry website and to speak to their physician to confirm the mandated reporting of ALS in Massachusetts if they wish to ensure reporting of their case.
How many states in the United States have population-based ALS registries?
Massachusetts hosts the only statewide ALS registry, which has been active since 2007. Florida, New Jersey, and Texas initiated pilot registries in 2011 along with six metropolitan cities across the nation as part of the development of a national registry with the U.S. Centers for Disease Control.
Is the public and medical community involved with the MDPH Massachusetts ALS Registry?
MDPH ALS Registry staff worked closely with an ALS advisory committee during the development process. The committee was comprised of health care providers, state legislators, patients and their families. The committee has continued to meet periodically to discuss the progress of the Registry to ensure the best interests of the ALS community are met.
Reporting Cases to the Registry
Who reports data to the Massachusetts ALS Registry?
All neurologists, hospitals, and clinics in Massachusetts report patients to MDPH, following state legislation (Massachusetts General Laws Chapter 111, Section 25A, as amended by Section 26 of Chapter 140 of the Acts of 2003) and MDPH regulations on reportable diseases (). Neurologists and hospitals are contacted annually to provide a patient’s name, date of birth, and medical record number. MDPH staff collects additional clinical information through scheduled visits to the reporting physicians’ office or hospital.
What are the reporting requirements by health care professionals and health facilities?
MDPH requires case reports on an annual basis, specifically identifying newly diagnosed ALS cases and information on disease progression among previously diagnosed ALS patients. Health professionals throughout the state are contacted at the beginning of each calendar year to report cases seen in the previous calendar year, providing the patient’s name, date of birth, and medical record number.
MDPH staff collect additional clinical information through a scheduled office visit. MDPH personnel are authorized to collect medical records and other identifiable information from health care providers, as well as from other persons, as required by 105 CMR 300.192 , in order to classify the diagnosis according to El Escorial criteria. All case information is checked for duplicate records to ensure accurate prevalence and incidence estimates.
Can patients “self-report” their case to the Massachusetts Registry?
Only cases reported by medical professionals are included in the state registry. Patients who wish to ensure reporting of their case should encourage their physicians to report. All neurologists statewide have been contacted about the necessary paperwork for reporting. Massachusetts public health regulations require neurologists, clinics, hospitals and other health professionals contacted to report patients diagnosed with ALS. For additional information your physician can contact MDPH at (617) 624-5757 and ask for the ALS Registry Coordinator.
ALS Registry Data and Confidentiality
What patient information does the Registry contain?
The Registry contains data on patient demographics (age, gender, address), clinical symptoms and laboratory data, diagnosis, and treatment. This is confidential information. The U.S. Health Insurance Portability and Accountability Act (HIPAA) allows physicians to report to MDPH for the purpose of disease surveillance.
How does MDPH protect confidentiality of the information in the registry and where and how is patient information shared?
All private health information collected by MDPH, including patient names, addresses, and medical records, is kept confidential and is protected by law. Confidential patient information may only be shared with researchers with approval of the MDPH Institutional Review Board (IRB) which reviews study proposals for scientific merit and requires strict provisions to protect patient confidentiality. In such instances, MDPH may share the minimally necessary information to meet the specific research purposes and only under strict IRB guidelines. Requests that receive IRB approval may also require researchers to first obtain a patient’s informed consent.
Will researchers be able to contact people identified in the Massachusetts Registry?
Researchers must apply for access to Registry data though a rigorous application process through the MDPH Institutional Review Board. Only those studies that can guarantee the continuous protection of patient confidentiality so that no individuals can ever be identified will be approved. Research projects that ensure the protection of privacy and that are approved by the MPDH must then contact patients to obtain informed consent to include them in their study. This type of research can help patients enroll in clinical trials and epidemiological research studies related to the causes of or treatments of ALS.
How will MDPH publicize and distribute ALS information from the Massachusetts ALS Registry?
MDPH will prepare reports containing community-specific and statewide prevalence and incidence estimates, as well as any trends occurring over time and across the state. No person will be identified or identifiable in any public documents. All Registry-related documents are available on the MDPH website. Data from the Registry will also be available by fall of 2016 on the MDPH Environmental Public Health Tracking website.