1
Discuss the benefits and problems associated with conducting patient satisfaction surveys to assess different types of medical interventions.
2
Should the FDA make worker productivity a mandatory measure for approval?
200 words each question no bullt point no plagiarism please
Ans) Total quality management (TQM) also referred to as
CQI
-the adoption of TQM has reduced lengths of stay, improved clinical
outcomes, and produced higher levels of patient satisfaction.
- patient satisfaction surveys have been used by health care
orgs
-ratings by consumers provide the most appropriate method for
evaluating interpersonal quality
FDA approval of a drug means that data on the drug’s effects have
been reviewed by CDER, and the drug is determined to provide
benefits that outweigh its known and potential risks for the
intended population. The drug approval process takes place within a
structured framework that includes:
• Analysis of the target condition and available treatments—FDA
reviewers analyze the condition or illness for which the drug is
intended and evaluate the current treatment landscape, which
provide the context for weighing the drug’s risks and benefits. For
example, a drug intended to treat patients with a life-threatening
disease for which no other therapy exists may be considered to have
benefits that outweigh the risks even if those risks would be
considered unacceptable for a condition that is not life
threatening.
• Assessment of benefits and risks from clinical data—FDA reviewers
evaluate clinical benefit and risk information submitted by the
drug maker, taking into account any uncertainties that may result
from imperfect or incomplete data. Generally, the agency expects
that the drug maker will submit results from two well-designed
clinical trials, to be sure that the findings from the first trial
are not the result of chance or bias. In certain cases, especially
if the disease is rare and multiple trials may not be feasible,
convincing evidence from one clinical trial may be enough. Evidence
that the drug will benefit the target population should outweigh
any risks and uncertainties.
Strategies for managing risks—All drugs have risks. Risk management
strategies include an FDA-approved drug label, which clearly
describes the drug’s benefits and risks, and how the risks can be
detected and managed. Sometimes, more effort is needed to manage
risks. In these cases, a drug maker may need to implement a Risk
Management and Mitigation Strategy (REMS).
Although many of the FDA’s risk-benefit assessments and decisions
are straightforward, sometimes the benefits and risks are uncertain
and may be difficult to interpret or predict. The agency and the
drug maker may reach different conclusions after analyzing the same
data, or there may be differences of opinion among members of the
FDA’s review team. As a science-led organization, FDA uses the best
scientific and technological information available to make
decisions through a deliberative process.
• Accelerated Approval
In some cases, the approval of a new drug is expedited. Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies. This approach allows for the approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit, or on a clinical endpoint that occurs earlier but may not be as robust as the standard endpoint used for approval. This approval pathway is especially useful when the drug is meant to treat a disease whose course is long, and an extended period of time is needed to measure its effect. After the drug enters the market, the drug maker is required to conduct post-marketing clinical trials to verify and describe the drug’s benefit. If further trials fail to verify the predicted clinical benefit, FDA may withdraw approval.
- Since the Accelerated Approval pathway was established in 1992, many drugs that treat life-threatening diseases have successfully been brought to market this way and have made a significant impact on disease course. For example, many antiretroviral drugs used to treat HIV/AIDS entered the market via accelerated approval, and subsequently altered the treatment paradigm. A number of targeted cancer-fighting drugs also have come onto the market through this pathway.
1 Discuss the benefits and problems associated with conducting patient satisfaction surveys to assess different types...
1 Discuss the benefits and problems associated with conducting patient satisfaction surveys to assess different types of medical interventions. 2 Should the FDA make worker productivity a mandatory measure for approval? 200 words each question no bullt point no plagiarism please
Article A Recent study of productivity in the workplace revealed that workers spend on average eight percent of their workday doing nothing. This statistic takes on greater significance when we find that health problems impact employee productivity loss by an even greater percentage. In light of this discovery, a group of leading experts from the emerging field of health and productivity research argues that the expansion of health care benefits represents a substantial investment opportunity for employers. Health and Work...
what discuss can you make about medicalization and chronic disease and illness? Adult Lealth Nursing Ethics mie B. Butts OBJECTIVES After reading this chapter, the reader should be able to do the following: 1. Explore the concept of medicalization as it relates to the societal shift away from physician predominance of the 1970s. 2. Differentiate among the following terms: compliance, noncompliance, adherence, nonadherence, and concordance. 3. Examine cultural views with regard to self-determination, decision making, and American healthcare professionals' values...
Below is the information: It is important to understand the different leadership styles employed by nursing leaders in healthcare organizations and to understand their significance on nursing practice and patient outcomes, for better or for worse. Objective: Read the articles from Nursing Standard (PDF) and Bradley University (PDF). In -250 words, formulate an opinion on the following: 1. Reflect on an occasion where you experienced ineffective leadership (doesn't have to be in the hospital). What behaviors did they display? What...
Industrial-organizational psychologists are interested in all of the following except1. how to best diagnose clinical disorders and offer therapy to employees.2. how personality characteristics influence work behavior.3. how culture influences people's perceptions of their working environments.4. how people's work affects their home life.An organizational psychologist would be most likely concerned with1. studying the interaction between humans and technology.2. All of the these3. interviewing potential employees.4. helping people organize their schedules and daily planners.5. understanding the emotional and motivational side of...
STEP 1: In your own words define problem employees and the categories they may fall into. For the second or last paragraph provide your opinion on which employee type is the most difficult. DEFINITION : I think that "problem employees" are employees that either directly or indirectly hinder the organization's mission or vision, and break down into roughly four categories. In general, problem employees can be classified into two broad categories - employees creating problems for the organization and employees...
Discussion questions 1. What is the link between internal marketing and service quality in the airline industry? 2. What internal marketing programmes could British Airways put into place to avoid further internal unrest? What potential is there to extend auch programmes to external partners? 3. What challenges may BA face in implementing an internal marketing programme to deliver value to its customers? (1981)ǐn the context ofbank marketing ths theme has bon pururd by other, nashri oriented towards the identification of...
QUESTION 1: Why must project manager should have good technical skills but also good management skills? QUESTION 2: **Communication and Communicator are related" This quote from the text suppose that the communication process is lead by the spokeperson. Do you think is it a gift" to be a good communicator or a skill to improve ( use example of your knowledge to answer)? QUESTION 3: Look at the text paragraph yellow highlighted, and do you think that in today's world...
1.what is the fundamental of knowledge management cycle or process? 2. what is knowledge cycle? 3. what is intellectual capital and three dimension of intellectual capital? 4. what is human capital? discusion with example 5. what is knowledge sharing and organization learning? 6. what is organization culture? 7. cultural impact of knowledge sharing? 8. what is data mining? 9. what is knowledge discover? UNIVERSAL Chapter 1 Knowledge Management Overview UBSS SCHOOL SYDNEY Introduction to Knowledge Management (KM) In a knowledge...
I need help with my very last assignment of this term PLEASE!!, and here are the instructions: After reading Chapter Two, “Keys to Successful IT Governance,” from Roger Kroft and Guy Scalzi’s book entitled, IT Governance in Hospitals and Health Systems, please refer to the following assignment instructions below. This chapter consists of interviews with executives identifying mistakes that are made when governing healthcare information technology (IT). The chapter is broken down into subheadings listing areas of importance to understand...