- Introduction
- The Selection of Instruments to Measure the Clinical Question Variables
- Validity and Reliability of the Instruments or Tools
- Methods for the Distribution and Collection of the Tools
- Addressing Potential Concerns for Confidentiality
- Methods of Protection of Participants
- Application of Analog or Technology
- Conclusion
- References
Introduction
The formulation and implementation of a healthcare project is a very critical process. Formulating a project entails settling on a course of action and making choices that will forward the healthcare organization’s strategic objectives. On the other hand, project planning focuses on getting the expected result (Portney, 2020).
There are various significant areas that a medical caregiver must be keen on when formulating and implementing a clinical project. For instance, the tools selection, confidentiality, and participants’ protection. This paper will extensively evaluate and discuss the selection of instruments or tools to measure the clinical question variables. It will highlight the validity and reliability of the instruments or tools. Lastly, it will discuss the methods for distributing and collecting the tools, address potential confidentiality concerns, protect participants, and apply analog or technology.
The Selection of Instruments to Measure the Clinical Question Variables
Choosing the right equipment or techniques to assess a clinical variable is complicated. The healthcare provider must consider all the options and decide based on what is best for the patient. There are various factors to consider when selecting the instruments and tools. For instance, the primary factor to consider is the tool’s alignment with the project’s goals (Gorstetal., 2020).
The most crucial consideration when choosing measuring equipment is how well the instrument fits the project’s purpose. The value of the data gleaned from a variable is directly related to how well it aligns. The more closely the instrument tracks with the project’s goals, the more precisely it may conclude its success. When alignment is poor, assessment reports cannot give helpful insight into the project.
Besides the alignment, another factor is the price of the equipment and materials and the resources needed. According to Gorstet al. (2020), many measuring tools can be acquired freely. However, others have to be purchased. It is vital to check the cost of these tools. Also, some resources might be required while using other tools. For instance, some tools will take time, effort, and the support of others to score and analyze data. Medical caregivers must carefully calculate how much time and money is needed to deploy each tool under consideration properly.
The quality of the instruments is the third consideration when selecting a clinical measuring tool. Like any other product, instruments may range in quality from excellent to terrible. The reliability of the scores generated by an instrument increases as its quality rises (Gorstet al., 2020). When dealing with patients, only the best equipment must be utilized. The more reliable the tool, the more beneficial the project’s outcomes will be. Medical professionals should not use an instrument’s results to guide project choices if they do not believe in their accuracy (Gorstetal., 2020). The instrument’s quality should be assessed before a final selection is made.
The last consideration is whether to use an existing instrument or develop a brand-new one. There are multiple existing measuring devices available nowadays. Using a pre-existing tool saves time and effort (Gorstet al., 2020). By repurposing an already-existing tool, medical practitioners save significant time and resources developing new instruments.
However, it might be challenging to locate a pre-existing tool that is a perfect fit for the unique goals of a project. If they make a new instrument, they may tweak it to align with their needs perfectly (Gorstet al., 2020). Whether to modify an existing tool or develop a new one depends on a trade-off between efficiency and consistency. Medical caregivers need to remember that developing an instrument is a costly process but that, in the end, they will be the ones to keep the instrument. Another option is to employ a pre-existing instrument, which may save time but may need payment to the instrument’s original developer.
Validity and Reliability of the Instruments or Tools
It is impossible to discuss tool selection without considering the validity and reliability of the measuring tools. The best measuring tools need to be valid and reliable. The validity of tools refers to how well an instrument measures its target variable and how closely the measured values match the target values.
Conversely, reliability refers to how consistently and reliably an evaluation tool yields accurate ratings (Bull, 2019). Validity and reliability are the most essential characteristics of a suitable measurement instrument. The primary goal throughout the instrument design and validation phases is to reduce Errors. Reliability estimates evaluate the tool’s stability of measurements, internal consistency of measuring instruments, and interrater reliability of instrument scores.
In many healthcare tools, the responsiveness of the measure to change is a core interest. Several factors, such as self-report and secondary data sources, might compromise the reliability of the information gathered. Patients’ or subjects’ self-reports are essential for many types of healthcare assessment; however, self-reports of behavior are especially vulnerable to issues with social desirability biases (Bull, 2019). It is common practice to utilize data collected for another reason to address a research topic. However, this might introduce bias in the results.
Methods for the Distribution and Collection of the Tools
The three ways clinical instruments can be disseminated and collected are paper-based, electronic, and hybrid. In paper-based methods such as Case Report Forms (CRFs), Data management enters information from these forms into a central database for monitoring and analysis (Portney, 2020). Portney(2020) notes that paper-based techniques of clinical data collection are an effective form of clinical data acquisition if they are used in conjunction with technological means.
In Electronic techniques, Data collected electronically is entered into a database without first being transcribed onto a case report form (Portney, 2020). There are two types of electronic techniques: centralized and distributed systems. In a centralized system, individuals in all locations can access the same database through the Internet. In a distributed system, each location has its own database that syncs with a central database.
Lastly, hybrid approaches combine the advantages of traditional paper procedures with modern digital ones. Researchers at the sites fill out paper CRFs specially designed for this purpose. Then, the forms are faxed to a central location, where they are scanned and fed into a computer using OCR (Optical Character Recognition) and OMR (Optical Magnetic Recognition) software (Portney, 2020).
The OCR program analyzes the CRF pictures and the markings, such as checkboxes, and converts them into editable text by the OMR module. The output of this program is used to update the central database with new information, and the OCR/OMR software flags any mistakes it finds in the CRF pictures. Once again, this eliminates the need for primary data input.
Addressing Potential Concerns for Confidentiality
Confidentiality concerns are very prominent in clinical projects. There are various ways in which potential confidentiality issues can be addressed. They first used stringent rules and strict privacy guarantees (George & Bhila, 2019). The medical staff must draw up comprehensive and detailed confidentiality agreements or rules when dealing with subjects to avoid confidentiality issues.
Another strategy for addressing confidentiality concerns is using encrypted storage for sensitive data. The number of patient records kept has skyrocketed as healthcare becomes more advanced and populations continue to grow significantly. Consequently, many practices and clinics have difficulties keeping important information appropriate regarding the locations where massive amounts of data may be stored and accessibility (George & Bhila, 2019). Due to these systemic challenges, patient information must be stored digitally with confidentiality and protection. The easiest method to take care of this is to purchase platforms or use cloud providers that guarantee the security of your data.
Finally, confidentiality issues can be addressed by not printing too much data. Printed materials are often ignored. Labs, forms, and other printed notes may be lost or stolen if left in a high-traffic location (George & Bhila, 2019). There is usually a high likelihood of losing printed documents. As a result, it is vital to reduce the use of printed materials, if not avoid them altogether. It is worth the cost of simplified, user-friendly, and secure printing solutions.
Methods of Protection of Participants
Participant safety is an essential consideration for any clinical project. Multiple policies have been enacted to protect research subjects. The safety of the participants may be ensured in many ways. First, respect should be maintained towards the partakers (Dove, 2020), and the Belmont principle of respect for individuals should be vital in all clinical research involving human subjects. All participants must provide their free and informed permission. Consent after being fully informed is not a one-time occurrence or a simple paper signature. Instead, it is a continuous conversation between the study’s doctor and those who could volunteer to be tested.
Besides respecting subjects, participants may be protected further via informed consent. There are three fundamental pillars of informed consent: voluntariness, comprehension, and disclosure (Dove, 2020). Partakers must know that their involvement is optional, can stop at any moment, and will suffer no adverse consequences. Reducing the likelihood of coercion and undue influence is essential to voluntary participation. To ensure comprehension(or their authorized representative), the medical researcher must choose the language they can grasp. Complete information about the study and the subject’s role must be provided throughout the consent procedure. The permission form must begin with a summary of the essential facts that will enable potential participants to decide whether to participate.
Application of Analog or Technology
The use of analog or technology in a clinical project is controversial. Most clinical researchers resist change and want to keep using analog methods since adopting new techniques is costly and requires much effort (Latif et al., 2020). On the other hand, Paper-based data gathering has significant drawbacks. For example, Researchers spend a lot of time transcribing massive amounts of data because they must collect data from sufficiently large samples for the study to be analyzed (Latif et al., 2020). This is the main problem with doing the old-fashioned route. The sheer volume of paper CRFs makes verifying their contents for correctness impractical.
Conclusion
In conclusion, clinical projects entail multiple areas that need keen study before formulation and implementation. The selection of tools is a critical area for the projects to be successful upon application. In addition, the medical caregivers must be concerned with the factors surrounding the participants due to multiple policies protecting them. Furthermore, when selecting the clinical instruments, quality issues must be weighed to promote effective and efficient care outcomes.
References
Bull, C., Byrnes, J., Hettiarachchi, R., & Downes, M. (2019). A systematic review of the validity and reliability of patient‐reported experience measures. Health Services Research, 54(5), 1023-1035. Web.
Dove, E. S. (2020). Regulatory stewardship of health research: Navigating participant protection and research promotion. Edward Elgar Publishing.
George, J., & Bhila, T. (2019). Security, confidentiality and privacy in health of healthcare data. International Journal of Trend in Scientific Research and Development, 3(4), 2456-6470. Web.
Gorst, S. L., Prinsen, C. A., Salcher-Konrad, M., Matvienko-Sikar, K., Williamson, P. R., & Terwee, C. B. (2020). Methods used in the selection of instruments for outcomes included in core outcome sets have improved since the publication of the COSMIN/COMET guideline. Journal of Clinical Epidemiology, 125, 64-75. Web.
Latif, S., Qadir, J., Qayyum, A., Usama, M., & Younis, S. (2020). Speech technology for healthcare: Opportunities, challenges, and state of the art. IEEE Reviews in Biomedical Engineering, 14, 342-356. Web.
Portney, L. G. (2020). Foundations of clinical research: Applications to evidence-based practice. FA Davis.