Which data elements must be collected directly by the clinician?
Some variables might be collected directly by the clinician for the registry or obtained from the medical record. Data elements that the clinician must collect directly (e.g., because of a particular definition or need to assess a specific comorbidity that may or may not be routinely present in the medical record) should be specified.
What is included in the BHSD clinical documentation manual?
BHSD Clinical Documentation Manual, Rev. June 2021 Page 9 of 121 18. For group notes, staff must detail the purpose of the group and individualize the note for each client. Documentation must include how the client benefitted from the group, the client’s participation, and their individual response to the interventions provided during the group.
What are the clinical treatment goals of sample clinical plan 1?
SAMPLE CLINICAL PLAN 1 Clinical Treatment Goals: Client will work on decreasing her behavior of isolation, by participating in social activities at least 1 time per week as reported by client.
How do you collect data in clinical research?
Introduction Data collection for clinical research involves gathering variables relevant to research hypotheses. These variables (‘patient parameters,’ ‘data items,’ ‘data elements,’ or ‘questions’) are aggregated into data-collection forms (‘Case Report Forms’ or CRFs) for study implementation.
Which treatments are included in a clinical trial?
People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care.
What is included in clinical data?
The data collected includes administrative and demographic information, diagnosis, treatment, prescription drugs, laboratory tests, physiologic monitoring data, hospitalization, patient insurance, etc. Individual organizations such as hospitals or health systems may provide access to internal staff.
What is DMP in clinical trials?
All clinical trials and studies should have a Data Management Plan (DMP), to ensure compliance with good data management practices. DMP is a written document that describes the plans for the collection and management of data throughout the lifecycle of a clinical trial.
What data is collected from clinical trials?
Collecting Meaningful Data in a Clinical Research StudyQuestionnaire Surveys and Patient Reported Data. ... Proxy/Informant Data. ... Review of Ambulatory or Hospital Medical Records. ... Collection of Biologic Material.
Which is an example of clinical data?
clinical datum: any single observation of a patient—e.g., a temperature reading, a red blood cell count, a past history of rubella, or a blood pressure reading.
What is common clinical data set?
The Common Clinical Data Set (CCDS) includes the Patient Name. The tester verifies that the CCDS includes the Patient Name. The CCDS includes the Date of Birth. The tester verifies that the CCDS includes Date of Birth.
What are the components of a DMP?
A typical DMP consists of the following eight components:Administrative Information.Data Collection.Documentation & Metadata.Ethics & Legal Compliance.Storage, Backup & Security.Selection & Preservation.Data Sharing.Responsibilities & Resources.
What should a data management plan include?
A Data Management Plan (DMP) describes data that will be acquired or produced during research; how the data will be managed, described, and stored, what standards you will use, and how data will be handled and protected during and after the completion of the project.
What is CRF in clinical data management?
Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data.
How is data collected in clinical research?
Different data collection approaches which are commonly used in the conduct of clinical research include questionnaire surveys, patient self-reported data, proxy/informant information, hospital and ambulatory medical records, as well as the collection and analysis of biologic samples.
What are some examples of healthcare data sets?
10 Great Healthcare Data SetsBig Cities Health Inventory Data. ... Healthcare Cost and Utilization Project (HCUP) ... data.gov. ... Kent Ridge Bio-medical Dataset. ... HealthData.gov. ... MHEALTH Dataset Data Set. ... Surveillance, Epidemiology & End Results (SEER)-Medicare Health Outcomes Survey (MHOS) ... The Human Mortality Database (HMD)More items...•
How do you analyze clinical data?
Box: Key questions to ask when assessing clinical dataWhat are the study's limitations? ... Does this apply to my patient? ... Is my patient sufficiently similar to the patients in the studies examined? ... Does the treatment have a clinically relevant benefit that outweighs the harms? ... Is another treatment better?More items...•
What are the sources of clinical data?
Depending on the measure, data can be collected from different sources, including medical records, patient surveys, and administrative databases used to pay bills or to manage care.
What is the difference between clinical data and public health data?
The easiest way to explain public health is that it deals with health from the perspective of populations, not individuals. The clinical health care provider — your doctor, nurse, or dentist — helps you with your own personal healthcare issues.
What are the important elements of clinical data warehouses?
CRDW data elements include patient demographics, lab values, procedure and diagnosis codes, medications, and visit information. Our self-service cohort discovery tools are an easy way to explore the data in the CRDW and see what's available.
How do you summarize clinical data?
The creation of clinical summaries can be modeled in the following five steps: Aggregation, Organization, Reduction and Transformation, Interpretation and Synthesis. Any or all of these steps could potentially be performed by either a clinician or an automated system in order to produce a concise and accurate summary.
What is data collection?
Data collection is the systematic process by which observations or measurements are gathered in research. It is used in many different contexts by...
What are the benefits of collecting data?
When conducting research, collecting original data has significant advantages: You can tailor data collection to your specific research aims (e.g...
What’s the difference between quantitative and qualitative methods?
Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings. Quantitative methods allow yo...
What’s the difference between reliability and validity?
Reliability and validity are both about how well a method measures something: Reliability refers to the consistency of a measure (whether the r...
What is operationalization?
Operationalization means turning abstract conceptual ideas into measurable observations. For example, the concept of social anxiety isn’t directly...
What is mixed methods research?
In mixed methods research , you use both qualitative and quantitative data collection and analysis methods to answer your research question .
What is the data collection procedure?
The data collection procedures for each registry should be clearly defined and described in a detailed manual. The term manual here refers to the reference information in any appropriate form, including hard copy, electronic, or via interactive Web or software-based systems. Although the detail of this manual may vary from registry to registry depending on the intended purpose, the required information generally includes protocols, policies, and procedures; the data collection instrument; and a listing of all the data elements and their full definitions. If the registry has optional fields (i.e., fields that do not have to be completed on every patient), these should be clearly specified.
What should be included in data review guidelines?
The guidelines should include information on how to handle missing data; invalid entries (e.g., multiple selections in a single-choice field, alphabetic data in a numeric field); erroneous entries (e.g., patients of the wrong gender answering gender-based questions); and inconsistent data (e.g., an answer to one question contradicting the answer to another one). The guidelines should also include procedures to attempt to remediate these data problems. For example, with a data error on an interview form, it may be necessary to query the interviewer or the patient, or to refer to other data sources that may be able to resolve the problem. Documentation of any data review activity and remediation efforts, including dates, times, and results of the query, should be maintained.
Why use standardized coding dictionaries?
As further described in Chapter 4, the use of standardized coding dictionaries is an increasingly important tool in the ability to aggregate registry data with other databases. As the health information community adopts standards, registries should routinely apply them unless there are specific reasons not to use such standard codes. While such codes should be implemented in the data dictionaries during registry planning, including all codes in the interface is not always possible. Some free text may be entered as a result. When free text data are entered into a registry, recoding these data using standardized dictionaries (e.g., MedDRA, WHODRUG, SNOMED ®) may be worthwhile. There is cost associated with recoding, and in general, it should be limited to data elements that will be used in analysis or that need to be combined or reconciled with other datasets, such as when a common safety database is maintained across multiple registries and studies.
What are the sources of data for a registry?
The sources of data for a registry may include new information collected from the patient, new or existing information reported by or derived from the clinician and the medical record, and ancillary stores of patient information, such as laboratory results. Since registries for evaluating patient outcomes should employ uniform and systematic methods of data collection, all data-related procedures—including the permitted sources of data; the data elements and their definitions; and the validity, reliability, or other quality requirements for the data collected from each source—should be predetermined and defined for all collectors of data. As described in Section 3, “Quality Assurance,” below, data quality is dependent on the entire chain of data collection and processing. Therefore, the validity and quality of the registry data as a whole ultimately derive from the least, not the most, rigorous link.
What is patient-reported data?
Patient-reported data are data specifically collected from the patient for the purposes of the registry rather than interpreted through a clinician or an indirect data source (e.g., laboratory value, pharmacy records). Such data may range from basic demographic information to validated scales of patient-reported outcomes (PROs). From an operational perspective, a wide range of issues should be considered in obtaining data directly from patients. These range from presentation (e.g., font size, language, reading level) to technologies (e.g., paper-and-pencil questionnaires, computer inputs, telephone or voice inputs, or hand-held patient diaries). Mistakes at this level can inadvertently bias patient selection, invalidate certain outcomes, or significantly affect cost. Limiting the access for patient reporting to particular languages or technologies may limit participation. Patients with specific diagnoses may have difficulties with specific technologies (e.g., small font size for visually impaired, paper and pencil for those with rheumatoid arthritis). Other choices, such as providing a PRO instrument in a format or method of delivery that differs from how it was validated (e.g., questionnaire rather than interview), may invalidate the results. For more information on patient-reported outcome development and use, see Chapter 5.
What is data enclave?
Data enclaves are secure, remote-access systems that allow researchers to share respondents' information in a controlled and confidential manner. 23 The data enclave uses statistical, technical, and operational controls at different levels chosen for the specific viewer. This can be useful both for enhancing protection of the data and for enabling certain organizations to access data in compliance with their own organization or agency requirements. Data enclaves also can be used to allow other researchers to access a registry's data in a controlled manner. With the growth of registries and their utility for a number of stakeholders, data enclaves will become increasingly important.
How to ensure data quality?
Steps for assuring data quality include: 1 Training: Educate data collectors/abstracters in a structured manner. 2 Data completeness: When possible, provide sites with immediate feedback on issues such as missing or out-of-range values and logical inconsistencies. 3 Data consistency: Compare across sites and over time. 4 Onsite audits for a sample of sites: Review screening logs and procedures and/or samples of data. 5 For-cause audits: Use both predetermined and data-informed methods to identify potential sites at higher suspicion for inaccuracy or intentional errors, such as discrepancies between enrollment and screening logs, narrow data ranges, and overly high or low enrollment.
What is data collection?
Data collection is a systematic process of gathering observations or measurements. Whether you are performing research for business, governmental or academic purposes, data collection allows you to gain first-hand knowledge and original insights into your research problem. While methods and aims may differ between fields, ...
What do you need to consider before collecting data?
Before you begin collecting data, you need to consider: The aim of the research. The type of data that you will collect. The methods and procedures you will use to collect, store, and process the data. To collect high-quality data that is relevant to your purposes, follow these four steps.
What is quantitative data?
Quantitative data is expressed in numbers and graphs and is analyzed through statistical methods. Qualitative data is expressed in words and analyzed through interpretations and categorizations. If your aim is to test a hypothesis, measure something precisely, or gain large-scale statistical insights, collect quantitative data.
Why do we need a sampling plan?
You may need to develop a sampling plan to obtain data systematically. This involves defining a population, the group you want to draw conclusions about, and a sample, the group you will actually collect data from. Your sampling method will determine how you recruit participants or obtain measurements for your study.
What should I do before collecting data?
Creating a data management plan. Before beginning data collection, you should also decide how you will organize and store your data. If you are collecting data from people, you will likely need to anonymize and safeguard the data to prevent leaks of sensitive information (e.g. names or identity numbers).
What is the purpose of archival research?
Archival research. To understand current or historical events, conditions or practices. Access manuscripts, documents or records from libraries, depositories or the internet.
Can you control and standardize the process for high reliability and validity?
You can control and standardize the process for high reliability and validity (e.g. choosing appropriate measurements and sampling methods) However, there are also some drawbacks: data collection can be time-consuming, labor-intensive and expensive.
Setting Up Standards For Success
Establishing standards requires a team effort and organizational buy-in from the very top. While a small working group hammers out the proposed templates or standards, executive support is needed at the beginning to get started in the right direction and at the end for final approvals.
Defining Data Standards
When it comes to data collection, overall endpoints and objectives are key. What data are necessary to feed your analysis? Standards should only collect what’s required to support your study objectives. Exploratory data is potentially useful, but diverts resources from critical data and places additional burden on patients and sites.
Establishing Governance, Deviations, and Updates
A successful standards program includes a formal change control process whereby individuals can ask for permission to deviate from the standards for their study. Email lacks the tracking and workflows that are necessary for effective management. Any deviation from a standard must be approved by the governance committee.
Fostering Adoption and Use
Many standards initiatives fail to deliver the promised efficiencies because deviation requests were too readily approved, or study teams proceeded independently without regard for the process. Therefore, fostering adoption of the standards across your organization is crucial to the success of your initiative.
Collaborating with Technology Providers
Technology partners are an important part of implementing any standards program. Sponsors must own the adoption and utilization of standards, but it is the vendors who often implement standards and leverage them when configuring systems, integrations, or case report forms. Here are three steps to maximize partner relationships.
Establishing and Maintaining Internal Data Standards
A successful standards program can produce significant efficiencies for your clinical team. Standards deliver faster builds in EDC systems, higher quality data entry at sites, easier and more complete reporting, more efficient cleaning and transformations, and simplified data sharing and analysis across sources and studies.
What is clinical data?
Clinical data is a staple resource for most health and medical research. Clinical data is either collected during the course of ongoing patient care or as part of a formal clinical trial program. Clinical data falls into six major types:
How many hospitals are there in the NCDR?
There are currently more than 2,400 hospitals and nearly 1,000 outpatient providers participating in NCDR registries. National Program of Cancer Registries. CDC provides support for states and territories to maintain registries that provide high-quality data.
What is the Golden Thread in CCBHS?
As each client begins services with CCBHS-MHP, there is a flow of information designed to support staff in providing services that help the clients meet their mental health goals. The concept of the Golden Thread should be apparent through the clinical documentation.
What is utilization review?
This process is meant to ensure that all planned clinical services are appropriate to address the client’s behavioral health needs. It is also meant to make sure that the records comply with all State and Federal regulations as well as CCBHS-MHP policies. The Utilization Review process includes the evaluation and improvement of services through the following practices:
What is the strategy section of a partnership plan?
The Strategies section on the Partnership Plan defines the concrete strategies and techniques the service provider proposes to utilize to facilitate the client’s progress of the clinical treatment goals. These strategies are behavioral health interventions and address the impairment(s) identified in the Assessment. They are best stated using the five W’s:
What is an initial assessment?
The Initial Assessment is designed to provide a comprehensive clinical picture of the client, to establish medical necessity, to help treatment teams and clients define goals and objectives, and to fulfill State and Federal requirements.
How long does it take to get a new provider on CCBHS?
If the client is receiving services from other service providers/agencies within CCBHS-MHP, the new (add-on) service provider will have thirty (30) days from the admission date to complete their documents for service authorization. The UR track has already been established and the new service provider will need to adhere to the annual UR track and complete all paperwork on the current timeline. In the event services are being transferred from one clinic to another and the client is still open on the original track, it is recommended the new provider complete an initial assessment.
What is clinical staff signature?
Clinical staff signatures are a required element of most clinical documents. At a minimum, signatures must include the first initial of the first name, the full last name, licensure and/or designation (e.g., ASW, MD, LMFT, MHRS, DMHW, PhD waivered, etc.), and date of signature.
Do you need a progress note for every billing entry?
While it has been noted that for every billing entry there must be a corresponding progress note, there are specific instances when documentation is not completed for every service contact.
Setting Up Standards For Success
Defining Data Standards
Establishing Governance, Deviations, and Updates
Fostering Adoption and Use
Collaborating with Technology Providers
Establishing and Maintaining Internal Data Standards
- A successful standards program can produce significant efficiencies for your clinical team. Standards deliverfaster builds in EDC systems, higher quality data entry at sites, easier and more complete reporting, moreefficient cleaning and transformations, and simplified data sharing and analysis across sources and studies.The benefits achieved play ...