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Chapter 12

Research: How Health Care Advances

CHAPTER OBJECTIVES

  • Identify and define different types of research and contributions each makes to health and medicine
  • Understand the origins and applications of health services research
  • Describe functions of the Agency for Healthcare Research & Quality and major quality initiative areas
  • Define new “comparative effectiveness research” and describe the Patient-Centered Outcomes Research Institute

Research Contributions to Medical Advances

  • Transition from dependence on physicians’ clinical impressions and anecdotal reports to statistically valid findings from controlled studies

Research Interpretation: Challenges

  • Volume of reports in popular media: difficult interpretation, evaluation of potential human applications
  • Premature report of findings
  • Sensationalism of minor scientific advances
  • Fraud

Types of Research

  • Basic Science (biomedical)
  • Clinical
  • Epidemiological
  • Health Services

Basic Science Research

  • Biochemists, physiologists, geneticists, pharmacologists
  • Much at cellular level
  • Antecedent to clinical advances
  • Understanding of growth, development, structures and functions of human body and response to stimuli

Clinical Research

  • Focus on steps in medical care process: diagnosis, treatment, rehabilitation, palliation
  • Much is experimental using controlled clinical trials
  • Conducted by all major disciplines: medicine, nursing, health related professions

Clinical Trials

  • Test new treatments, drugs, medical devices against prevailing standard of care
  • May use control groups to minimize subject bias
  • Random selection of treatment & control group members further reduces bias
  • Double-blinded, placebo controls are most rigorous

Safeguards Protecting Volunteer Subjects

  • Peer review committees to judge scientific merit
  • Institutional Review Boards review ethical considerations
  • Informed consents detail: potential risks, side effects, expected benefits

Epidemiology (1)

  • Epidemiology (population) research: distribution & determinants of health, diseases, injuries in human populations. Much is observational (descriptive or analytical):
  • Collects information about natural phenomena, characteristics, behaviors of people, peoples’ locations & environments, exposures to circumstances or events

Epidemiology: Descriptive Studies

  • Use patient records, interview surveys, databases, other information to identify factors determining distribution of health and disease among specific populations
  • Relatively fast, inexpensive; may suggest hypotheses or raise questions for future study

Epidemiology: Analytic Studies

  • Under naturally occurring conditions, to observe differences between two or more populations with different characteristics or behaviors
  • Try to explain biologic phenomena by statistical association between factors that may contribute to a subsequent occurrence

Epidemiology: Analytic Study Examples

  • Data about smokers and non-smokers to determine relative risk of an outcome such as lung cancer
  • Cohort studies such as Framingham follow a cohort to determine associations among variables such as diet, weight, exercise and other behaviors related to heart disease and other outcomes

Experimental Epidemiology

  • Often follow analytic studies; most rigorous
  • Investigator actively intervenes by manipulating one variable to observe effect on other; control populations ensure that other, non-experimental variables do not affect outcomes.
  • Technically difficult
  • Ethical concerns: unknown risks; withholding potentially beneficial drug or treatment among controls

Other Applications of Epidemiological Methods

  • Health services planning, administration and evaluation
  • Forecasting population group health needs
  • Assess adequacy of health personnel supply
  • Determine outcomes of specific treatments in clinical settings
  • Statistical computing advances enable analysis, interpretation from massive (e.g. Medicare) data bases

Health Services Research (1)

  • Medicare, Medicaid, other subsidy programs drove development of HSR
  • Revealed cost, utilization data, variations in quality, indecision, confusion about effective treatments
  • need to improve efficiency, effectiveness of health care & determine which treatment options produce best outcomes for specific conditions

Health Services Research (2)

  • Combines perspectives & methods of epidemiology, sociology, economics & clinical medicine
  • Uses process & outcome measures reflecting behavioral and economic variables associated with therapeutic effectiveness and cost benefit

Health Services Research (3)

  • Agency for Health Care Policy & Research (AHCPR): est. 1989 in US Public Health Service, Department of HHS
  • Response to Wennberg studies on clinical variations; promoted development of clinically relevant guidelines to assist health care practitioners in prevention, diagnosis, treatment

Agency for Healthcare Policy and Research, 1989-1996

  • Medical Treatment Effectiveness Program:
  • identified and analyzed patient outcomes associated with alternative practice patterns and recommended changes through patient outcomes research teams & literature synthesis projects (meta-analyses)
  • 1996: controversial recommendation regarding back surgery guidelines changed mission

Healthcare Research and Quality Act of 1999

  • Renamed AHCPR to Agency for Healthcare Research & Quality (AHRQ); Mission:
  • Improve outcomes & quality of health care services
  • Reduce costs
  • Address patient safety
  • Increase service effectiveness through research to promote clinical & systems improvements , disease prevention

AHRQ Today

  • Top priority: providing research findings & new health information to create and ensure evidence-base for practice guidelines (14,000 to date)
  • Many consumer-oriented publications
  • User-friendly, internet access
  • Strong congressional and presidential support emanate from medical errors & quality concerns

Health Services Research and Health Policy

Contributions of HSR to Policy

  • Wennberg studies of small area variation in medical utilization
  • Prospective payment based on DRGs
  • Research on inappropriate medical procedures
  • Resource-based MD payments
  • Concepts of HMOs and managed care

Quality Improvement (1)

  • Evidence-based clinical quality review evolved in 1980s following
  • Prior “peer review” relied on factual knowledge and inexplicable judgment, intuition of individual physicians about individual patients
  • Quality assurance focused on exceptionally poor care, “bad apples.” Quality defined as “absence of mishap,” offensive to physicians, ineffective

Quality Improvement (2)

  • As early as 1966, “quality” recognized as objectively measureable and quantifiable

Avedis Donabedian: introduced structure, process, outcomes, research paradigm of their linkages

  • Structure: number, types, skills of providers; facilities, equipment
  • Process: diagnostic, treatment activities
  • Outcomes: patient results as assessed by providers

Quality Improvement (3)

  • To assess health care practice quality, early landmark studies used implicit & explicit normative or judgmental standards
  • Implicit standards rely on internalized judgments of experts
  • Explicit standards developed and agreed on in advance of quality assessment; minimize variation & bias resulting from internalized judgments

Quality Improvement: Empirical Standards

  • Derived from distributions, averages, ranges & other measures of data variability; compare data collected from many similar health service providers to identify practices deviating from a norm; E.g., Medicare’s “Hospital Compare;” state-based severity-adjusted cardiovascular surgery outcomes by physician

Quality Improvement: Evidence-Based Medicine

  • “Systematic application of best available evidence to evaluate options & decisions in clinical practice & management.”
  • Variability in clinical practice, test complexity, difficulty in staying current, suggest many clinical decisions not supported by evidence of effectiveness
  • Today, cost-control pressures and outcomes emphasis are stimulating evidence-based approaches

Quality Improvement (6)

  • Medical errors: 1999-IOM cited two major studies estimating that 44,000-98,000 hospital patients died annually from medical errors; Congress funded AHRQ funded for focus on patient safety
  • 2005: Patient Safety and Quality Improvement Act: est. Patient Safety Organizations to encourage voluntary reporting & remediation of risks

Quality Improvement (7)

  • Evidence-based medicine: “Systematic application of best available evidence to evaluate options & decisions in clinical practice & management.”
  • Variability in clinical practice, test complexity, difficulty in staying current, suggest many clinical decisions not supported by evidence of effectiveness
  • Today, cost-control pressures and outcomes emphasis are stimulating evidence-based approaches

Quality Improvement (8)

  • Evidence based medicine, “cont’d
  • EB approach considers evidence from large, randomized clinical trials valid; dismisses outcomes research using large data files created from insurance claims records or other sources because subjects are not randomized.
  • “Outcomes research using claims data is excellent ..to find out what doctors are doing, but …terrible way to find out what they should be doing”

Quality Improvement: Outcomes Research

  • Evaluates health care results in real world of medical offices, hospitals, clinics, homes
  • Contrasts with studies of treatments in controlled environments
  • Questions justification of treatment costs for health, well-being of patients, population
  • Insurers, government, employers, consumers seek outcomes information to make better decisions

Quality Improvement: Outcomes Research

  • Defines health status in measures of patient functional status, well-being, satisfaction with care, not only laboratory findings, recovery and survival rates:
  • Physical functioning
  • Role functioning: health interference with activity
  • Social functioning: health effects on normal social activities

Comparative Effectiveness Research (CER)

  • ARRA of 2009: $ 1.1 B to expand CER by AHRQ, NIH: improve health care treatment decisions by providing information to consumers, providers, payers on effectiveness, benefits, harms of treatment options; uses research evidence comparing drugs, medical devices, tests, surgeries or ways to delivery health care
  • 10 research priority areas identified by IOM

Comparative Effectiveness Research (CER)

  • ACA of 2010 created Patient-Centered Outcomes Research Institute (PCORI), not-for-profit independent agency dedicated to CER; $ 1.2 B allocated 2010-2019.
  • Disseminate research findings quickly useable by clinicians, patients, policy makers, health plans and other payers

Quality Improvement (13)

  • Patient satisfaction: Quality perceived by patients derives from subjective criteria different from providers’
  • Competitive market climate: increases research importance of provider characteristics, systems, communication, facilities and other factors
  • Measurement instruments: self-administered surveys, phone interviews identify positive and negative patient perceptions useful for improvement strategies, marketing

Research Ethics

  • Priorities and profit motives drive remedial, at the expense of preventive research
  • Taxpayer supported research on new technologies focused on ameliorating disease: benefits for medicine vs. community at large
  • PCORI focus on all stakeholders with major voice of consumers has potential to shift focus toward greater community benefit.

Conflicts of Interest in Research

  • Research funding shifted from academic institutions to pharmaceutical and medical device companies creates potential for biased findings
  • Political, pharmaceutical manufacturers’ influences result in clinical trial findings held as “trade secrets,” impeding public reports on safety and efficacy
  • “Ghostwritten” publications by medical school professors

Future Challenges (1)

  • New focus on defining and improving health of population groups shifts research priorities solely focused on disease diagnosis and treatments
  • ACA initiatives such as the PCORI will require changes in provider behaviors, acceptance of new information, new reimbursement methods, new resources for information dissemination

Future Challenges (2)

  • Ethical, legal, economic, religious, professional dilemmas may arise as
  • Basic science research in genomics yields positive breakthroughs
  • Clinical advances continue in areas such as life-prolonging technology and organ transplantation
  • Health services research identifies more issues in the equity of healthcare distribution and access in the reformed system

Future Challenges (3)

  • Public health research must be funded to use the scope of its disciplines with epidemiology as the core, to increase understanding of differences among populations’ health, health behaviors, health care and health systems.