Analysis 1 and 2 Criteria

Course Overview

One of the hallmarks of a profession is the unique body of knowledge that supports its practice behaviors. That knowledge was methodically developed and critically appraised. While only a relatively small proportion of health science and professionals might have the interest or opportunity to undertake a full blown research project, ALL health professionals have the charge to be able to critically review scientific evidence and apply it to solving problems & answering questions in their everyday health care settings.

Perhaps some of you have studied research in your AA or AS programs or maybe even created and presented Table Clinics or Poster Sessions at your professional meetings. Whether you have or have not implemented formalized research projects, it is certainly true that we all conduct “mini research studies” hour-after-hour, day-after-day in our professional settings.

Professional standards in health disciplines today call for the use of evidence-based practice. The most common source of evidence comes from research. One of the most reliable sources of evidence-based research information is published study results found in peer reviewed journals.

As professionals in the field you will often need to evaluate professional literature to identify current evidence, best practices and relevance to your discipline. The ability to find valid, reliable published literature and determine its applicability to your needs are skills that are required in many job positions in the health and human services fields, and thus are skills that are critical to your professional success.

While “becoming” a professional researcher is generally a specific career goal, critically analyzing the soundness of scientific research studies and using what we find to guide our practice behaviors is a standard that is expected of each of us as Baccalaureate health care professionals.

To be able to critically analyze the scientific literature and be a good “consumer” of evidence-based literature, it is necessary to have a basic knowledge of the research process and the elements of research studies.

ANALYSIS #1ASSIGNMENT and ANALYSIS #2 ASSIGNMENT

 

You have learned much during the first few weeks of this course and this Analysis assignment is an opportunity for you to pull all of your learning together.  To be successful on this assignment, apply everything that you have learned from your readings, the discussion forums, and the module information pages.

 

For additional help, download and review page in Module 3 that identifies the Major Elements of a Research Article.

 

CRITERIA FOR ANALYZING A RESEARCH STUDY

 

·         Download this word document to your computer.

 

·         Include the Assignment Rubric at the end of your document.

 

·         Create a title page by putting your cursor above the table and clicking down until you have a blank title page to format OR  using Insert Tab-> blank page

 

·         Carefully follow all directions for this assignment.

 

·         Remember to provide evidence to support your responses as well as citations and references (including the article you are analyzing)!For example, when answering 1b. You would include how your problem statement meets the 5 criteria for problem statements that you learned in Module 1. Include citations and references from the textbook, course content, and your research article throughout your analysis.

 

  • Use the sameresearch study that you selected in Select a Study in Module 2 to answer these questions for Analyses #1 & 2.

 

  • You must use a question and answer format and include the entire question prior to your response.  Your paper will not be accepted if the instructions are not followed completely.

 

  • Be sure to format your paper so that the questions are in one color of font, and your responses are in a different color of font. Use only black or royal blue fonts.

 

  • Your well thought out and comprehensive answers to the analysis questions will generate a critical analysis of your research article, a skill that all baccalaureate-prepared, health care and human services professionals need to acquire in order to provide evidence-based care to their patients/clients.
  • Remember to provide evidence from your readings to support your answers. In other words, cite and reference the article, the readings and course material to support your work.This is required.Failure to support your work will result in point loss.

 

  • Use APA format for all citations and references.  Use the correct file naming procedure for your submissions.

 

  • For Analysis #1 answer: 1,2,3,4,5 (covers modules 1-3); (Due Module 4)

 

  • For Analysis #2 answer: 6,7,8, 9,10 (covers Modules 4-6); (Due Module 6)

 

 

 

1.  Problem Statement/Purpose Statement

a. What is thecomplete Title of the research experiment that you selected in Module 2?

b. Follow the samefive criteriadirections you did in the Module 1 “Problems Everywhere” discussion forum andwrite a problem statement for this research experiment. (Hint: citations and references needed; use the readings to inform/guide/support your responses throughout this paper).

c.   Using the definition for a research “purpose”, what do you think the purpose of this research experiment is?

d.    In your opinion is this experiment important to our health care system in this country?  Why?  Why not?

2.   Research Question/Hypotheses

a. Using your textbook and course content define the term hypothesis and write one for the research study you are analyzing.

Hypothesis:

b. Using your textbook (hint: citations and references needed) and course content define the term simple hypothesis and write one for the research study you are analyzing. Then define the following terms and use yoursimple hypothesis to write a directional and anull hypothesis. 

Simple hypothesis:

 

Directional hypothesis:

 

Null hypothesis:

 

3.   Identification and Operational Definitions of Study Variables

a.   Name theindependent and dependent variable/s in your study?

IV

DV

b.    Concept of Operationalization: In an experimental research study the researchers are hoping to find that applying the IV willchange the DV.  In other words,suppose thatresearchers are hoping to find that after applying fluoride to teeth (IV) those teeth will be strengthened (DV).  If so, after applying the fluoride to the teeth (IV) the researchers would have to examine the teeth (DV) for any changes in strength.

SO, with that example in mind, after the IV is applied or used in your study,howdid the researchers going to collect data on their DV(exactly how did they determine if the IV had changed/had an impact on the DV; exactly how did they know that the DV had been impacted or changed) Please explain thoroughly.

 

4.   Literature Review

Before researchers begin their experiment they review the literature to see what previous experiments might have taken place using the same or similar variables; nobody wants to reinvent a wheel. Literature Reviews are relatively short and are always locatedbetween the abstract and the methods sections of a research article. Locate the Literature Review in your research study.  It will be below the abstract, before methods and either:

  • under a section called Introduction
  • OR Literature Review
  • OR there will be no specific heading.

Note that it is NOT in the Abstract.

a.   Where, SPECIFICALLY, is the Literature Review in your article? (Page number?  Column? Paragraph/s?)

b.   Read carefully through the Literature Review section in your experiment and name thespecific variables that are being addressed in the Literature review section only

c. After reviewing the course content on primary and secondary sources search the reference page of your article for 1 primary source OR 1 secondary source that you are certain about just from reading the title in the citationTell me the number of the citation and whether that citation is primary or secondary.  Use the readings/course content to provide a rationale for your selection (i.e.,use the buzz words that are posted on the content page to help you).  Remember:  make your decision based ONLY on the title.

d.   At the beginning or end of the Literature Review and before the Methods section the researchers summarize what they found in earlier studies on the variables of interest.  Researchers use this summary to point out a GAP in the literature.  A gap is something that is still not understood,something that theseresearchers hope to understand after conducting their study. What GAP did these researchers point out in your study?  Please explain thoroughly.

 

5.  Study Design

a. Using your understanding of the multiple research study designs from your textbook and the content pages what research designwas used for this study(i.e., provide a definition of the type of design that you identify in your research article)?

b. In your opinion, was this design appropriate for this study?  Why or why not? Base this on evidence from your readings and course content.

c. Were threats to internal validity (extraneous variables) controlled in this study?  How? Give specific examples.

d. Think of another extraneous variable that should/could be controlled in thisstudy?  Why? (i.e., how do you think this variable might impact the DV or the outcome of the study?)

e.   How would YOU have controlled for this extraneous variable?

 

 

 

6.  Protection of Human Subjects in Research

a. Do the researchers indicate that they took steps to protect the human subjects that were a part of their study?  Identify what steps they took and how they describe their application to their research study.  Explain why this is necessary/required (I need to “hear” that you understand the meaning, importance and ethical necessity of these measures in your response.

 

7.Population, Sample, and Setting

a. Who/what is the POPULATION for this study?

NOTE: No matter what the researchers themselves tell you, do not be fooled into thinking that the sample is the population!  This is a common misconception in research studies!  Remember, the population is the complete set of persons or things possessing the characteristics that the researchers want to study/want to infer their results to.  At the end of the study (in the Discussion, Implications, Limitationssections) researchers discuss who their results are beinginferred to or generalized to:  all of the smokers?  The overweight?  The grieving?These are often much different than the limited group they sampled:  i.e., a military base, hospitals in another country, etc.It is a very good idea to read these sectionsbeforedetermining WHO or WHAT the population is for this studyYou might be very surprised!

b. Specifically, how was the SAMPLE selected from this population?  Exactly how did they select the actual participants – what was the process? (i.e., were there inclusion and exclusion criteria; how did they recruit the sample and determine who would become part of the study, or who would be excluded?)

c. How large was the sample?  Tell me the exact number that actually participated in the study #! (just give me ONE number here)

d. In your opinion does the sample “represent” the population for this study? (i.e., is the sample similar to the overall population that the researchers might want to infer the results to?)  How so? Explain your answer.

e. Where did this study take place:  Laboratory?  Clinic?   School?  Other?

 

8.    Data collection INSTRUMENT

Data are collected so that researchers can measure the impact that the IV has had on the DV.Instrumentsare used to collect these data. Are the instruments surveys of some type?Are they scales?Or telephones?  Questionnaires? Interviews?  Lab tests?  Other? Review carefully – remember instruments used may be more than things like thermometers, scales, etc.

a.   WHAT specificinstrument/s was/were used to COLLECT DATAin this study? (I am looking for the instrument/s, not the data.). For example, what did the researchers use to measure/collect data for the study outcome (DV)?

b.   How did theresearchers describe their data collection INSTRUMENT/s and how they used it/them? Be specific.

c.  Using definitions and descriptions of RELIABILITYpresented on the content pages and the inter/intraobserver reliabilityposting forum to begin your response, describe what steps were taken to assure that the data collected in this study are reliable?  (i.e., Were the observers calibrated?  Did they Standardize their procedures?  Was their data collection instrument calibrated?Standardized?  Tell me everything you see that suggests that theseresearchers tried to collectreliabledata. Explain your answer thoroughly.

 

9.  Data analysis procedures.       Remember****: data analysisprocedures are different than data collectioninstruments/tools!

a.   Define descriptive statistics and identify/name theDESCRIPTIVE statistics used to organize, describe and summarize data in thisstudy.  Review the content pages on descriptive statistics, the posting forum on Statistics in the media AND Topics 47, 49, 50, 54, 55, 56 of your textbook before answering this criterion and be sure to incorporate the information into your response.

b.   Define inferential statistics and identify/name the INFERENTIAL statistics used to infer results to the population.Review the content pages on inferential statistics,Topics 47, 51, 58, 59, 60, 61 in your textbook AND the Statistics in the Media posting forum before answering this criterion.

c.   Google the name of ONE of the Inferential statistical tests mentioned in your research study.   What does your source say about this inferential test?   Why do you think your authors chose this inferential test for their study (think about the Levels of Measurement for example)?  Please explain. Please provide a link to your findingsand do not forget tocite the information and write a referencepage citationon this source, as well.

 

10.  Conclusions/implications/limitations

a. In light of this research experiment’smethodswhat do you think is the major strength of this study?  Please support your response thoroughly.This question refers to the study methods, not the purpose or outcome of the study.

b.   In YOUR opinion what is/are the study’s major limitation/s?  Please support your response thoroughly.Again, this question is related to the study design and methods – not the outcomes for the study.

c.   Please look at the Acknowledgment section, orany area of your study that acknowledgesfunding sources.  Review adjectives for the term BIAS (click your thesaurus in WORD). Define bias and indicate whether or notthefunding source/s listedin this research study suggest that the study’s findings maybe biased.  Please defend your answer thoroughlyand let me hear that you understand the research concept of bias in your response!

 

 

 

The new engl and jour nal of medicine

original article  
 

A Communication Strategy and Brochure  for Relatives of Patients Dying in the ICU

Alexandre Lautrette, M.D., Michael Darmon, M.D., Bruno Megarbane, M.D., Ph.D.,

Luc Marie Joly, M.D., Sylvie Chevret, M.D., Ph.D., Christophe Adrie, M.D., Ph.D., Didier Barnoud, M.D., Gérard Bleichner, M.D., Cédric Bruel, M.D.,

Gérald Choukroun, M.D., J. Randall Curtis, M.D., M.P.H., Fabienne Fieux, M.D.,

Richard Galliot, M.D., Maité Garrouste-Orgeas, M.D., Hugues Georges, M.D.,

Dany Goldgran-Toledano, M.D., Mercé Jourdain, M.D., Ph.D., Georges Loubert, M.D., Jean Reignier, M.D., Fayçal Saidi, M.D., Bertrand Souweine, M.D., Ph.D.,

François Vincent, M.D., Nancy Kentish Barnes, Ph.D., Frédéric Pochard, M.D., Ph.D., Benoit Schlemmer, M.D., and Elie Azoulay, M.D., Ph.D.

Abstract

Background

There is a need for close communication with relatives of patients dying in the intensive care unit (ICU). We evaluated a format that included a proactive end-of-life conference and a brochure to see whether it could lessen the effects of bereavement.

Methods

Family members of 126 patients dying in 22 ICUs in France were randomly assigned to the intervention format or to the customary end-of-life conference. Participants were interviewed by telephone 90 days after the death with the use of the Impact of Event Scale (IES; scores range from 0, indicating no symptoms, to 75, indicating severe symptoms related to post-traumatic stress disorder [PTSD]) and the Hospital Anxiety and Depression Scale (HADS; subscale scores range from 0, indicating no distress, to 21, indicating maximum distress).

Results

Participants in the intervention group had longer conferences than those in the control group (median, 30 minutes [interquartile range, 19 to 45] vs. 20 minutes [interquartile range, 15 to 30]; P<0.001) and spent more of the time talking (median, 14 minutes [interquartile range, 8 to 20] vs. 5 minutes [interquartile range, 5 to 10]). On day 90, the 56 participants in the intervention group who responded to the telephone interview had a significantly lower median IES score than the 52 participants in the control group (27 vs. 39, P = 0.02) and a lower prevalence of PTSD-related symptoms (45% vs. 69%, P = 0.01). The median HADS score was also lower in the intervention group (11, vs. 17 in the control group; P = 0.004), and symptoms of both anxiety and depression were less prevalent (anxiety, 45% vs. 67%; P = 0.02; depression, 29% vs. 56%; P = 0.003).

Conclusions

Providing relatives of patients who are dying in the ICU with a brochure on bereavement and using a proactive communication strategy that includes longer conferences and more time for family members to talk may lessen the burden of bereavement. (ClinicalTrials.gov number, NCT00331877.)

n engl j med 356;5        www.nejm.org       february 1, 2007

From the Saint-Louis Hospital and Paris 7 University, Assistance Publique — Hôpitaux de Paris (A.L., M.D., S.C., F.F., N.K.B., F.P., B.S., E.A.), Lariboisière Hospital (B.M.), Bichat-Claude Bernard Hospital

(C.B.), and Cochin Hospital and Paris 5 René Descartes University (G.C.) — all in Paris; Rouen University Hospital, Rouen (L.M.J.), Saint-Denis Hospital, Saint-Denis (C.A.), University Hospital, Grenoble (D.B.), Argenteuil Hospital, Argenteuil (G.B.),

Pontoise Hospital, Pontoise (R.G.), SaintJoseph Hospital, Saint-Joseph (M.G.-O.); Tourcoing Hospital, Tourcoing (H.G.), Gonesse Hospital, Gonesse (D.G.-T.), Salengro Hospital, Lille (M.J.), Raymond Poincaré Hospital, University of Versailles, Versailles (G.L.), La Roche sur Yon Hospital, La Roche sur Yon (J.R.), Nemours Hospital, Nemours (F.S.), Clermont-Ferrand Hospital, Clermont-Ferrand (B.S.), and Avicenne Hospital, Avicenne (F.V.) — all in France; and the School of Medicine, University of Washington, Seattle (J.R.C.). Address reprint requests to Dr. Azoulay at Service de Réanimation Médicale, Hôpital Saint-Louis, 1 Ave. Claude Vellefaux, 75010 Paris, France, or at elie.azoulay@ sls.aphp.fr.

N Engl J Med 2007;356:469-78.

Copyright © 2007 Massachusetts Medical Society.

H

aving a loved one die in the intensive care unit (ICU) is an extraordinarily stressful event.1 The patient is usu-

ally unable to communicate with the family or with ICU staff. Qualitative and quantitative studies of families in this situation2 have identified effective communication between caregivers and families and support from caregivers throughout the decision-making process as important to fam-

ily members.3-9

In many ICUs, an end-of-life family conference, which is rooted in findings from epidemiologic and interventional studies on communicating with families of dying patients, is an important part of ICU practice.10 In these conferences, family members and ICU staff discuss the patient’s situation in a quiet room. Ideally, family members are given opportunities to ask questions, express concerns, and confront painful emotions with the help of caring, compassionate professionals.11,12

Although the conference is important, the effect of its structure on bereaved family members has not been evaluated in a randomized trial. We conducted a multicenter, randomized, controlled study to evaluate the effect of a proactive communication strategy that consisted of an end-oflife family conference conducted according to specific guidelines and that concluded with the provision of a brochure on bereavement. We hypothesized that this intervention, as compared with the customary end-of-life conference, would decrease stress-related symptoms and symptoms of anxiety and depression in family members 90 days after the patient’s death.

Methods

We conducted a prospective, randomized, controlled trial in 22 ICUs (Table 1) in France from May 2005 to October 2005. The study was approved by the institutional review board of the French Society for Critical Care, and oral informed consent was obtained from the participating families. At each ICU, one investigator was responsible for the study, which included six consecutive patients and their surrogates. On day 90, one mem-

 

Table 1. Characteristics of the 22 ICUs in the Study.  
Characteristic Value
Teaching hospital — no. (%) 15 (68)
Type of ICU — no. (%)  
Medical 10 (45)
Surgical 3 (14)
Medical and surgical 9 (41)
No. of attending physicians — median (interquartile range) 6 (5–6)
No. of residents — median (interquartile range) 3 (3–4)
No. of patients per nurse — median (interquartile range) 3 (3–3)
No. of beds — median (interquartile range) 16 (12–21)
Rooms with more than two beds — no. (%) 10 (45)
Regular (at least weekly) nurse–physician meetings — no. (%) 19 (86)
Availability of bereavement brochure before study began — no. 0
Research group on end-of-life family care — no. (%)* 8 (36)
End-of-life family conferences held before study began — no. 0
Routine involvement of family members in daily care — no. (%) 8 (36)
Routine involvement of family members in decisions — no. (%) 8 (36)
No. of family–staff conflicts in 2004 — median (interquartile range) 25 (12–41)
No. of visiting hours per day — median (interquartile range) 4 (2–8)
Unrestricted visiting hours — no. (%) 5 (23)
Psychologist present in ICU — no.(%) 5 (23)
  • The research groups consisted of nurses and doctors who met weekly to discuss how to improve the quality of care.
Table 2. Characteristics of Patients and Enrolled Family Members at Time of ICU Admission.  
Characteristic

Patients

Control

Group (N = 63)

Intervention

Group (N = 63)

P Value
Age — yr     0.10
Median 68 74  
Interquartile range 56–76 56–80  
Male sex — no. (%) 37 (59) 33 (52) 0.47
French descent — no. (%) 56 (89) 58 (92) 0.60
Unmarried — no. (%) 15 (24) 21 (33) 0.23
Direct admission to ICU — no. (%) 34 (54) 37 (59) 0.77
Coexisting conditions — no. (%)      
Chronic obstructive pulmonary disease 13 (21) 13 (21) 0.99
Chronic heart failure 10 (16) 14 (22) 0.36
Cancer 21 (33) 12 (19) 0.10
Cirrhosis 2 (3) 5 (8) 0.24
Poor performance status — no. (%) 28 (44) 27 (43) 0.61
Reason for ICU admission — no. (%)      
Acute respiratory failure 28 (44) 27 (43) 0.85
Coma 27 (43) 25 (40) 0.71
Shock 21 (33) 24 (38) 0.57
Acute renal failure 11 (18) 14 (22) 0.50
Cardiac arrest 14 (22) 16 (25) 0.67
Simplified Acute Physiology Score — median  (interquartile range)† 64 (52–76) 59 (52–81) 0.85
Treatment needed at end of life — no. (%)      
Mechanical ventilation 56 (89) 58 (92) 0.54
Vasopressors 42 (67) 49 (78) 0.23
Dialysis 16 (25) 14 (22) 0.67
Sedation 47 (75) 49 (78) 0.83
Family members‡      
Male sex — no. (%) 12 (23) 17 (30) 0.39
Age — yr     0.48
Median 54 54  
Interquartile range 46–64 47–58  
French descent — no. (%) 46 (88) 48 (86) 0.35
Catholic — no. (%) 35 (67) 35 (63) 0.78
Married — no. (%) 24 (46) 22 (39) 0.57
Relationship to patient — no. (%)     0.45
Spouse 22 (42) 20 (36)  
Child 22 (42) 30 (54)  
Parent 5 (10) 2 (4)  
Other 3 (6) 4 (7)  
  • Indicates that the participants and their parents were born in France.
  • Scores range from 0 to 163, with higher scores indicating more severe illness.
  • Data are for the 52 family members in the control group and the 56 family members in the intervention group who were interviewed at 90 days.

 

ber of each family — either the patient’s designated surrogate or the person who ranked highest in the hierarchy for surrogate decision making — was interviewed.13 Additional methodologic details are presented in the Supplementary Appendix, available with the full text of this article at www.nejm.org.

Table 3. Implementation of the Intervention and End-of-Life Care, Including Decisions to Forgo Life-Sustaining

Treatments.*

                                                                                                                      Control             Intervention

Group                     Group                    P

Variable                                                                                                                                                              (N = 63)                  (N = 63)             Value

Implementation of intervention

Family informed of decision to forgo life-sustaining treatment — no. (%)          61 (97)                   63 (100)                0.99
More than one family member informed of decision — no. (%)                                55 (87)                   58 (92)                  0.55
Involvement of family in decision — no. (%)
     No involvement                                                                                                                                        2 (3)                              0                        0.15
    Family members expressed patient’s wishes                                                                      34 (54)                   44 (70)                  0.04
   Family members expressed their own wishes                                                                    53 (84)                   44 (70)                  0.05
End-of-life conference
No. of family members present                                                                                                                                                                               0.07
     Median                                                                                                                                                               2                                 3
    Interquartile range                                                                                                                                   2–3                           2–3
Nurse present — no. (%)                                                                                                                        38 (60)                   51 (81)                  0.03
No. of ICU physicians present                                                                                                                                                                                   0.05
     Median                                                                                                                                                               1                                 2
    Interquartile range                                                                                                                                   1–2                           1–2
Duration of conference — min                                                                                                                                                                          <0.001
     Median                                                                                                                                                              20                              30
    Interquartile range                                                                                                                                15–30                     19–45
Total time that family members spoke — min                                                                                                                                        <0.001
     Median                                                                                                                                                               5                              13.5
    Interquartile range                                                                                                                                 5–10                        8–20
Total time that nurse spoke — min                                                                                                                                                                   0.006
     Median                                                                                                                                                               1                                 3
    Interquartile range                                                                                                                                   0–3                         0.5–5
Clinicians’ observations — no. (%)
    Family expressed guilt                                                                                                                       13 (21)                      7 (11)                   0.01
   Family reported successful expression of emotions                                                       47 (75)                   60 (95)                  0.03
  Family believed that patient’s symptoms were controlled                                        61 (97)                   61 (97)                  0.99
    Family reported conflicts with ICU staff                                                                                    1 (2)                         1 (2)                     0.95

Participant Selection and Study Procedures The only criterion for inclusion in the study was the belief by the physician in charge that the patient would die within a few days. Patients young-

er than 18 years of age were excluded from the study, as were family members who had insufficient knowledge of French for a telephone interview. Table 2 lists characteristics of the patients and family members. Surrogates were assigned at random to the intervention or control group. In the control group, interactions between the family and the ICU staff, including the end-oflife conference, occurred according to the usual practice at each center. In the intervention group, the end-of-life family conference was held in accordance with detailed guidelines developed by

one of the authors at the University of Washington.10,14,15 Families were given a brochure on bereavement (see the Supplementary Appendix for the original French version and a version translated into English by the authors). The end-of-life conference used in the intervention group had five objectives for the caregivers, summarized by the mnemonic VALUE10,14,15: to value and appreciate what the family members said, to acknowledge the family members’ emotions, to listen, to ask questions that would allow the caregiver to understand who the patient was as a person, and to elicit questions from the family members. Each investigator received a detailed description of the conference procedure.10 Randomization was performed centrally in blocks of six, stratified according to the ICU, with group assignments sent in sealed envelopes to the study centers (for details see the Supplementary Appendix). Outcome Measures

Table 3. (Continued.)      
Variable Control

Group (N = 63)

Intervention

Group 

(N = 63)

P

Value

End-of-life care      
Decision to forgo life-sustaining treatments — no. (%) 63 (100) 63 (100) 1.00
No. of days from ICU admission to decision     0.38
Median 5 2  
Interquartile range 2–10 2–14  
Nonbeneficial interventions after end-of-life conference — no. (%)      
Mechanical ventilation 47 (75) 41 (65) 0.30
Vasopressors 23 (37) 17 (27) 0.33
Dialysis 1 (2) 0 0.99
Other† 35 (56) 28 (44) 0.16
No. of nonbeneficial interventions provided after decision to forgo  life-sustaining treatments     0.04
Median 3 2  
Interquartile range 2–3 2–3  
Life-sustaining treatments withdrawn — no. (%)      
Mechanical ventilation 9 (14) 17 (27) 0.03
Vasopressors 19 (30) 32 (51) 0.01
Dialysis 15 (24) 14 (22) 0.78
Other data      
No. of days from decision to forgo life-sustaining treatments to death     0.16
Median 2 1  
Interquartile range 1–3 1–2  
No. of days in ICU     0.54
Median 9 7  
Interquartile range 5–20 4–14  
Conflicts with family members reported by ICU staff — no. (%) 4 (6) 8 (13) 0.36
Patients who survived and were discharged — no. (%) 2 (3) 1 (2) 0.30

* The intervention began on the day that the end-of-life family conference was held. † Other treatments were blood transfusions, antibiotics, and vitamins.

One family member per patient was interviewed over the telephone 90 days after the patient’s death; the interviews took place between August 2005 and January 2006. The primary outcome measure was the score on the Impact of Event Scale

(IES), which assesses symptoms related to posttraumatic stress disorder (PTSD); scores range from 0 (no PTSD-related symptoms) to 75 (severe PTSD-related symptoms).5,16-18 We classified patients as having low or high IES scores, using 30 as the cutoff, in agreement with previous reports.5,18 Secondary outcome measures were symptoms of anxiety and depression, which we assessed using the Hospital Anxiety and Depression Scale (HADS); subscale scores range from 0 (no distress) to 21 (severe distress).19,20 HADS subscale scores above 8 were considered to indicate clinically significant symptoms of anxiety or depression.19

Data Collection

Investigators recorded ICU and patient characteristics on standardized forms. The data elements included in Table 3 were gathered in a prospective fashion. In addition, a specific form was used to collect data describing the end-of-life family conference, and investigators were asked to clock family conference times. Primary-outcome data were collected by the interviewer 90 days after the patient’s death. Statistical Analysis

On the basis of data from our previous study,5 we hypothesized that the intervention would decrease the risk of PTSD-related symptoms by 30%. To detect a significant difference between the two groups with a type I error of 0.05 and a power of 0.90, 100 families had to be recruited, 50 in each group. We decided to include 132 family members (66 in each group) to allow for families lost to follow-up on day 90 (up to 25%).5 Continuous variables were reported as medians and interquartile ranges, and categorical variables as proportions. Comparisons of continuous variables between the two randomized groups were performed with the Wilcoxon rank-sum test, whereas comparisons of categorical variables were performed with the Pearson chi-square test or Fisher’s exact test, as appropriate. All tests were two-sided, and P values of less than 0.05 were considered to indicate statistical significance. Statistical tests were performed with the SAS software package, version 9.1 (SAS Institute).

Results

Of the 132 eligible family members, 126 were randomly assigned to a study group, and 108 (86%) were interviewed 3 months after the patient’s death (range, 90 to 104 days) (Fig. 1). Of the 22 ICUs in the study, 15 were in teaching hospitals, and 7 in general hospitals. In all the ICUs, nurses and physicians held regular meetings about end-of-life issues; however, only three ICUs had written procedures for delivering information to families of dying patients, and only five ICUs had unrestricted visiting hours. Before the study, none of the ICUs provided family members with written information about bereavement, and none were aware of the VALUE-based guidelines for end-oflife conferences. The characteristics of the patients at enrollment did not differ significantly between the two study groups. A decision to forgo life-sustaining treatment was made for all the study patients; at the time that the decision was implemented, 114 patients (90%) were receiving mechanical ventilation and 96 (76%) were deeply sedated, precluding meaningful communication between the patient and family.

A comparison of the characteristics of the end-of-life conferences in the two study groups provides a measure of the implementation of the intervention. The significant differences in the conduct of the conferences, shown in Table 3, suggest that the guidelines for the intervention conferences were followed.2,21

Figure 1. Enrollment, Randomization, and Follow-up of Study Participants.

Regarding the prespecified process-of-care measures listed in Table 3, although the length of stay in the ICU and in the hospital did not differ significantly between the intervention and control groups, there were fewer nonbeneficial interventions (continued life support after a decision to withhold or withdraw life-sustaining treatments) in the intervention group (see Fig. 1 of the Supplementary Appendix), and withdrawal of mechanical ventilation and vasopressors was more common in this group than in the control group. Among the relatives who initially disagreed with the ICU clinicians regarding decisions to forgo life-sustaining treatments, those in the intervention group were more likely to agree with the decisions eventually (six relatives in the intervention group vs. none in the control group, P = 0.02). Among the family members in both groups, 96 (89%) reported that the amount of time spent providing information was sufficient, and 97 (90%) felt that the information was clear; 41 (38%) reported a desire for additional information that was not provided (Table 4). The proportions of family members who reported a desire for additional information, who received newly prescribed psychotropic drugs, and who expressed feelings of guilt were lower in the intervention group than in the control group. In addition, 95% of family members in the intervention group said they were able to express their emotions to the ICU team, as compared with only 75% of family members in the control group.

Regarding the prespecified main outcome variables recorded 90 days after the death of the patient (Table 4), the IES scores in the intervention group were lower than those in the control group (median score, 27 [interquartile range, 18 to 42] vs. 39 [interquartile range, 25 to 48]; P = 0.02), indicating that 25 family members in the intervention group (45%) were at risk for PTSD as compared with 36 (69%) in the control group. Similarly, family members in the intervention group had significantly lower HADS scores than those in the control group (median score, 11 [interquartile range, 8 to 18] vs. 17 [interquartile range, 11 to 25]; P = 0.004), with 25 family members (45%) reporting clinically significant symptoms of anxiety and 16 (29%) reporting clinically significant symptoms of depression, as compared with 35 (67%) and 29 (56%) in the control group, respectively (P = 0.02 and P=0.003, respectively) (Fig. 2).

Discussion

Over the past decade, epidemiologic studies have identified the specific needs of family members of dying patients,3-7 thereby allowing the development of proactive interventions that have improved communication with family members.22,23 End-of-life family conferences are rooted in the evidence provided by this literature, their main goals being to improve communication between ICU staff and family members and to assist families when difficult decisions need to be made.10,11,14 In our multicenter, randomized study, we compared two end-of-life conference formats, one reflecting a proactive approach to communication and ending with the provision of a brochure on bereavement, and the other reflecting the typical approach used by each center. The proactive communication strategy decreased PTSD-related symptoms and symptoms of anxiety and depression among family members.

Table 4. Outcomes Assessed on Day 90.      
Variable Control

Group

(N=52)

Intervention

Group

(N=56)

P Value
IES score     0.02
Median 39 27  
Interquartile range 25–48 18–42  
Presence of PTSD-related symptoms (IES score >30) — no. (%) 36 (69) 25 (45) 0.01
HADS score     0.004
Median 17 11  
Interquartile range 11–25 8–18  
Symptoms of anxiety — no. (%) 35 (67) 25 (45) 0.02
Symptoms of depression — no. (%) 29 (56) 16 (29) 0.003
Saw a psychologist after death of patient — no. (%) 6 (12) 4 (7) 0.41
Received newly prescribed psychotropic drugs after death of patient — no. (%) 12 (23) 6 (11) 0.05
Effectiveness of overall information provided — no. (%)      
Time allotted to provide information was sufficient 45 (87) 51 (91) 0.45
Information was clear 45 (87) 52 (93) 0.34
Additional information requested 24 (46) 17 (30) 0.05

In the intervention group, ICU clinicians were asked to follow detailed published guidelines14,15to ensure a uniform and effective change in their approach to communication. As compared with the control conferences, the intervention conferences were attended by a larger number of relatives and were associated with longer times spent delivering information and listening to relatives. The intervention conferences also provided family members with more opportunities to discuss the patient’s wishes, to express emotions, to alleviate feelings of guilt, and to understand the goals of care. Our finding that patients in the intervention group received fewer nonbeneficial treatments concurs with evidence of the efficacy of proactive strategies such as ethics consultation24 and early palliative-care consultation for dying patients in the ICU.25

A bereavement brochure was given to the family at the end of the intervention conference. Previous studies by our research group showed that comprehension was markedly improved by simply delivering standardized written information for families.23 This experience prompted us to include a brochure in our proactive communication strategy. Furthermore, prior research suggests that multifaceted interventions are necessary to effect changes in clinicians’ behavior.26

Our study has several limitations. First, it was performed in France, where the patient–physician relationship is perceived as more paternalistic than elsewhere,27 with physicians having final authority in decisions to forgo life-sustaining treatments.5 Nonetheless, the intervention used in our study was rooted in the international literature and is relevant to other countries.2 It might be argued that the gap between the intervention and the control groups was larger as a result of paternalistic attitudes in the control group, since this group replicated usual practice; if this view is correct, the magnitude of the beneficial effect of the intervention in France would be greater than could be expected in countries where shared decision making with family members is more firmly established. A strong argument against this view, however, is the fact that interactions with family members in the control group were similar to those reported in other European countries and in North America.14,15 Furthermore, the results of our intervention were consistent with those in earlier studies of proactive interventions.22,24,25 In addition, 22 centers participated in our study, further enhancing the generalizability of our findings.

Second, our only criterion for inclusion in the study was the belief on the part of the physician in charge that death was inevitable and that a decision to forgo life-sustaining treatment was in order. In some cases, however, patients in such

Global Anxiety Depression Scale Subscale Subscale
Figure 2. HADS Scores in the Two Randomized Groups. The median HADS score was 11 (range, 8 to 18) in the intervention group versus 17 (range, 11 to 25) in the control group (P = 0.004). With a cutoff of 8 for each  of the subscales, symptoms of anxiety and depression were less common in the intervention group (anxiety, 25 patients [45%], vs. 35 [67%] in the control group;

P = 0.02; depression, 16 [29%] vs. 29 [56%]; P = 0.003).

circumstances survive.28,29 Conceivably, our intervention might have a negative effect on the family members of patients who survive, a situation that transpired only once in this study. Nevertheless, the possible negative effects of such an event must be compared with the negative effects of suboptimal communication on the much larger number of families whose relatives die.

Third, we did not determine how many families read the bereavement brochure or how those who did reacted to it. The multicenter design of the study and the fact that each ICU physician held only three intervention conferences did not allow us to evaluate the physicians’ learning curve. Previous work has shown that even a brief course of training may improve communication skills.30 A study over time would be useful to determine whether benefits to the families increase as ICU physicians improve their communication skills. There is a need to develop a process for evaluating and improving end-of-life conferences in ICUs. Also, to make sure that the interviewer was unaware of the group assignments, we did not ask questions about the intervention itself during the telephone interview.

Fourth, because we did not assess the HADS score before the critical illness or at the time of the patient’s death, we cannot be sure that the two groups of family members were not different at baseline. However, in a recent noninterventional study, we recorded the HADS score for family members 90 days after the patient’s discharge or death.5 The median score was 17 (interquartile range, 10 to 22), suggesting not only that symptoms of anxiety and depression were common and lasting but also that the proactive communication strategy we tested in the current study had positive effects.

Fifth, although the interviewer and the analyst were unaware of the group assignments, blinding of family members and ICU clinicians was not feasible. Consequently, we cannot exclude the possibility that the investigators believed strongly in the effectiveness of the intervention and that this may have influenced other interactions with family members.

Finally, the positive results of the current study might in theory indicate that in the control group, communication was less personalized and interactive than the norm. However, we believe that the characteristics of the control conferences (reported in Table 3) — notably, their longer duration, as compared with that in earlier work by our group (20 minutes vs. 10 minutes) — show that communication with families was as good as, or better than, the norm. In addition, the proportion of relatives who were satisfied with the information they received and the proportion who requested additional information indicate that the standard of care for providing information was met.5,23,31 The fact that the IES and HADS scores in the control group were similar to those in our previous studies argues against the possibility that the control conferences were substandard, as does the extensive experience acquired over the years by the ICU physicians in our study group.5,19,23,31-34

In summary, a proactive strategy for routine end-of-life family conferences that included provision of a brochure on bereavement, as compared with customary practice, resulted in longer meetings in which families had more opportunities to speak and to express emotions, felt more supported in making difficult decisions, experienced more relief from guilt, and were more likely to accept realistic goals of care. The result of this strategy was a decrease in PTSD-related symptoms and symptoms of anxiety and depression 3 months after the patient’s death.

 

Proactive communication strategy at the end of life

Supported by grants from Assistance Publique–Hôpitaux Dr. Azoulay reports receiving grant support from Pfizer. No de Paris and the French Society for Critical Care Medicine other potential conflict of interest relevant to this article was (AOR01004). The study was performed on behalf of the Famirea reported.

Study Group. Dr. Curtis was supported by a grant from the Na- We thank A. Wolfe, M.D., for help with the manuscript. tional Institute of Nursing Research (RO1NR005226).

 

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Copyright © 2007 Massachusetts Medical Society.

 

New England Journal of Medicine

CORRECTION

A Communication Strategy and Brochure for

Relatives of Patients Dying in the ICU

A Communication Strategy and Brochure for Relatives of Patients Dying in the ICU . Dr. Azoulay’s e-mail address (page 469) should have read “elie.azoulay@sls.aphp.fr.´´ The text has been corrected on the Journal’s Web site at www.nejm.org.

N Engl J Med 2007;357:203-a

Downloaded from www.nejm.org at ST PETERSBURG COLL on March 4, 2008 . Copyright © 2007 Massachusetts Medical Society. All rights reserved.

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