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Mixed Methods Research in Practice:Decision Making about Life Support in
Intensive Care Units
Douglas B. White, MD, MAS
Assistant Professor of Medicine
Division of Pulmonary and Critical Care Medicine
Investigator, UCSF Program in Medical Ethics
Overview
What is qualitative research?
What is mixed methods research?
Criteria to evaluate the quality of mixed methods research
Examples of models of mixed methods research
Previously healthy 71-year man admitted to the ICU with a large stroke. He develops severe pneumonia w/ resp failure, sepsis and renal failure.
Aphasic, R hemiparesis APACHE II: 35; In-hospital mortality 70% Significant functional impairment Patient decisionally incapacitated
Should life support be continued?
Surrogate decision-making No clear “right” medical answer Preference-sensitive decision
Why study communication of prognosis?
1. Patients/Families have: A right to know
• autonomy & informed DM
A need to know• Prognostic info affects treatment choices
2. Prognostic misunderstandings are common
Lloyd CB. Crit Care Med 2004; 32:649-54
Prognostic Information Changes Patients Decisions about Life Support
I Shouldn't Have Had To Beg for a PrognosisWith all the conflicting reports on his health, I didn't know if he was holding steady or dying.
Aug. 22, 2005 issue - I was once a stalker. My victims—yes, there were several—were high on the social scale, but they were not celebrities. They were doctors.…
What causes physician-family discordance about prognosis?
No discussion about prognosis?
Poor MD communication skills?
Low health literacy/numeracy?
Undo optimism by families?
Lack of trust in physicians?
Different attitudes about whether clinicians can predict the future?
Different attitudes about what determines a patient’s prognosis
Little empirical research about mechanisms
The Structure-Process-Outcome Paradigm: Prognosis Communication in the ICU
Process of care:- # prognosis discussions- Process/Content of discussion
Outcome MD-family agreementre: prognosis
Family characteristics:- literacy/numeracy- optimism- depression-trust in physician- Explanatory models of future telling
Physiciancharacteristics:-Demographics-Skills - Attitudes
Goals of Doing Qualitative Research and the Alternatives
Goals of Research Develop hypotheses Develop framework for
understanding phenomenon
Understand multiple perspectives
Understand why patients or clinicians do what they do
Alternative to Research Make up hypothesis Use pre-existing framework
or conceptual model Use expert or clinical
perspective Guess why they do what
they do
Qualitative Methodologies
Grounded theory Content analysis Ethnography Naturalistic inquiry Discourse analysis Phenomenology
Unifying trait:Inductive reasoning “Moving from detailed facts to
general principles”
Deductive reasoning: “Reasoning from general
principles to the particular”
Ex.: Beta-blocker use in AMI
Questions begging for a qualitative approach
Why do patients not take their medications?
How do people make end-of-life decisions?
What are the barriers to implementing semi-recumbency to prevent pneumonia in ICUs?
A Quantitative or Qualitative Design?
Quantitative Establish incidence
and prevalence Measure risks and
frequency of events Determine treatment
effectiveness
Qualitative Describe phenomenon Understand thinking,
behavior Describe “why”
interventions do or don’t work
What is Mixed Methods Research?
“Research that includes both QUAL and QUANT data collection and analysis in parallel form (in which two types of data are collected and analyzed) or in sequential form (in which one type of data provides a basis for collection of another type of data).
Tashakkori and Teddlie; 2003, Handbook of mixed methods in social and behavioral research
Why Use a Mixed Methods Approach?
THE reason: the research question demands it. When neither method is sufficient to capture the
trends and details of a subject. Guide quantitative instrument development. Triangulate findings on 1 topic from 2
methodologic approaches. Comprehensive evaluation of an intervention.
NIH Guidelines for Rigor in Mixed Methods Research
1) What is the rationale for mixing methods? Why valuable for the study aims?
• To identify questions relevant for instrument design• To gain a comprehensive understanding of the
phenomenon• To triangulate findings (to enhance claims of
validity)
NIH. Qualitative Methods in Health . 1999 Creswell JW. Ann Fam Med. 2004; 2:7-12.
NIH Guidelines for Rigor in Mixed Methods Research
2) Which method takes priority? Depends on goal
• Develop instrument: QUAL informs QUANT goal of reliable and valid instrument.
• Develop theory: QUAL predominates; QUANT can provide useful ancillary data.
• Explain phenomenon: Equal weight to QUAL and QUANT inquiries.
NIH. Qualitative Methods in Health . 1999 Creswell JW. Ann Fam Med. 2004; 2:7-12.
NIH Guidelines for Rigor in Mixed Methods Research
3) How are the methods implemented? Concurrent vs Sequential
• Concurrent: simultaneous QUAL and QUANT data collection
• Sequential: One method serves as foundation for subsequent method.
– Qualitative data from semistructured interviews identify relevant domains for quantitative instrument.
NIH. Qualitative Methods in Health . 1999 Creswell JW. Ann Fam Med. 2004; 2:7-12.
NIH Guidelines for Rigor in Mixed Methods Research
4) When are the data integrated?• During data collection:
– Ex. 1: QUAL data examined, then transformed into QUANT instrument.
– Ex. 2: QUAL coding of audiotapes transformed into quantitative group of predictors to determine association with outcome.
• During synthesis of results: – Ex. 1: Investigators use their expertise to synthesize data
and draw inferences/conclusionsa.
NIH. Qualitative Methods in Health . 1999 Creswell JW. Ann Fam Med. 2004; 2:7-12.
Mixed Methods Designs: 1. Instrument Development
Create quantitative tools informed by qualitative methods
Pursue QUAL research to ensure comprehensiveness of instrument.
QUAL QUANT RESULTS
Assessing the Quality of Mixed Methods Research
1) Rationale for mixed methods: To inductively develop an instrument
2) Priority: Qualitative
3) Implementation: Sequential
4) Integration: During data collection
NIH. Qualitative Methods in Health . 1999 Creswell JW. Ann Fam Med. 2004; 2:7-12.
Mixed Methods Designs: 2. Explanatory Model
Qualitative data and analysis are used to explain quantitative data (e.g., patterns in the data, or the meaning of outliers)
QUAL
QUANT RESULTS
Example: Physician-family discordance about prognosis:
Misunderstanding vs Different Belief?
Background: Small qualitative studies in other domains of healthcare suggest that discordance might arise from different explanatory models of future telling.
Aim: To determine whether different belief systems contribute to MD-family discordance about prognosis.
Design: Prospective cohort study
Subjects: 175 surrogate decision makers for ICU patients with >50% chance mortality.
Example: Physician-family discordance about prognosis:
Misunderstanding vs Different Belief?
MEASUREMENTS:Quantitative data:
Surrogate’s estimate of patient’s prognosis for hospital survival
Surrogate’s estimate of what the physician thinks is the prognosis.
Qualitative data: Semi-structured interview: “I notice that your estimate is different from/the same as
what you think the doctor thinks. Can you tell me a little about why?”
0% chance of survival
100% chance
of survival
1.What do you think are the chances that the patient will survive this hospitalization if the current treatment plan is continued? Place a mark on the line…
0% chance of survival
100% chance of
survival
Outcome Measure- Prognostic Discordance
What do you think the doctor thinks are the chances that the patient will survive this hospitalization if the current treatment plan is continued? Place a mark on the line…
Example: Physician-family discordance about prognosis:
Misunderstanding vs Different Belief?
QUALITATIVE ANALYSIS: Interviews were audiotaped and transcribed Coding by multidisciplinary team Grounded theory methods
Performed open coding- line-by-line (5 transcripts) Multiple investigator meetings axial coding (grouping
individual codes into organizing framework) Coded 5 more transcriptsRevised codebook Reliability: kappa > 0.60 for all codes
Example: Physician-family discordance about prognosis:
Misunderstanding vs Different Belief?
Quantitative Results:
35% (50/143) held a different belief about the prognosis than their guess of the MD’s estimate.
Mean difference (absolute)=15%; (range 10-100%)
Example: Physician-family discordance about prognosis:
Misunderstanding vs Different Belief?
Qualitative Results:
Disagreement
PATIENT•Physical strength•Emotional strength“He’s a fighter”•Past history of “beating odds”
FAMILY•Miracles•Family presence can alter outcome•Conscious optimism•Need to disbelieve
PHYSICIAN•Overly pessimistic•Lack faith•Don’t know patient•Can’t predict future
Assessing the Quality of Mixed Methods Research
1) Rationale for mixed methods: To explain an observed quantitative relationship
2) Priority: Qualitative
3) Implementation: Concurrent
4) Integration: During data collection and analysis
NIH. Qualitative Methods in Health . 1999 Creswell JW. Ann Fam Med. 2004; 2:7-12.
Mixed Methods Designs: 3. Triangulation Model
Pursue QUANT and QUAL methods in parallel Research: Study subject using more than one way of
knowing; more than one viewpoint Enhance comprehensiveness of findings.
QUAL QUANT
RESULTS
CONCLUSIONS
RESULTS
SYNTHESIS
Assessing the Quality of Mixed Methods Research
1) Rationale for mixed methods: To gain a comprehensive understanding
2) Priority: Equal
3) Implementation: Concurrent
4) Integration: Analysis phase
NIH. Qualitative Methods in Health . 1999 Creswell JW. Ann Fam Med. 2004; 2:7-12.
Mixed Methods Designs: Data Transformation Model
Initial qualitative analysis of data to develop codes, then using descriptive statistics to describe how often they are observed
Transform QUAL findings into quantative and use
conventional statistical methods.
QUAL
QUANT(outcome)
RESULTS
QUANT (predictor)
Transform data
Example of Data Transformation Model: Emotional Support during ICU Family Conferences
QUAL: To understand how physicians emotionally support family members making EOL decisions for ICU patients.
QUANT: To determine whether specific physician behaviors are associated with higher family satisfaction.
Example: Emotional Support and Family Satisfaction during EOL Decision Making
Design:Design: Prospective multi-center, study of 51 Prospective multi-center, study of 51 audiotaped physician-family discussions about EOL audiotaped physician-family discussions about EOL decision-makingdecision-making
Setting:Setting: Adult ICUs of 4 Seattle-area hospitals Adult ICUs of 4 Seattle-area hospitals
Measurements: Measurements: QUAL: Transcripts inductively coded using grounded QUAL: Transcripts inductively coded using grounded
theory methodstheory methods QUANT: validated instrument assessing family QUANT: validated instrument assessing family
satisfaction with communicationsatisfaction with communication
Curtis JR. J Crit Care; 2000
Example: Emotional Support and Family Satisfaction during EOL Decision Making
Qualitative Results:Qualitative Results: Support for end-of-life decisionsSupport for end-of-life decisions Addresses family issues Addresses patient as a person Nonabandonment All is being done Reassures about comfort Support for hopes Acknowledges emotions expressed Acknowledges the complexity Offers assistanceOffers assistance Being direct about dyingBeing direct about dying Elicits questionsElicits questions ListensListens
Curtis JR. J Crit Care; 2000
Emotional Support Associated with Higher Family Satisfaction
Higher family satisfaction when MDs:• Expressed empathy (p <0.05)
– “I imagine it must be hard for you to see your father this way”• Assured nonabandonment (p<0.05):
– “Even if we stop life support, we won’t stop taking care of her.”
• Assured comfort (p<0.05): – “We’ll make sure she’s not SOB and not in pain.”
• Expressed support for family’s decisions (p<0.05)– “I fully support this plan and this is what I would do if it were
my son in the bed.”
Stapleton, Crit Care Med, 2006White DB. Under review 2007
The Effect of a Proactive Communication Strategy on Bereavement Outcomes
Design:Design: Multi-center, randomized controlled trial in 22 Multi-center, randomized controlled trial in 22 Adult ICUsAdult ICUs
Subjects:Subjects: 126 family members of patients whom MD 126 family members of patients whom MD thought would not survivethought would not survive
InterventionIntervention: : MDs trained to do the following:MDs trained to do the following:VValue the attitudes/decisions of the familyalue the attitudes/decisions of the familyAAcknowledge family members’ emotions cknowledge family members’ emotions LListenistenUUnderstand the patient as a personnderstand the patient as a personEElicit questions from the familylicit questions from the family
Measurements:Measurements: PTSD symptoms at 90 days assessed by IES PTSD symptoms at 90 days assessed by IES (range 0-75)(range 0-75)
Results:Results: Intervention group had significantly lower PTSD Intervention group had significantly lower PTSD symptom scores compared to control group (27 vs 39; p=0.02)symptom scores compared to control group (27 vs 39; p=0.02)
Lautrette A. NEJM 2007 ;356: 469-78
Conclusions
Mixed methods studies are particularly advantageous for some, but certainly not all, topic areas
“Grounds” our work, so that we ask the important questions, avoid omitting insights, and have realistic hypotheses.
Increases the potential that research will be more easily translated into practice