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AMBULATORY ANESTHESIA

Assessing a Tool to Measure Patient Functional Ability After Outpatient Surgery

Susan L. Hogue, PharmD, MPH^*, Pat Ray Reese, PhD, Michael Colopy, PhD^*, Lee A. Fleisher, MD, Kenneth J. Tuman, MD^§, Rebecca S. Twersky, MD^¶, David S. Warner, MD^#, and Brenda Jamerson, PharmD^*

*Department of Global Health Outcomes, Glaxo Wellcome Inc.; Strategic Outcomes Services, Inc., Research Triangle Park, North Carolina; Department of Anesthesiology, Johns Hopkins University, Baltimore, Maryland; §Department of Anesthesiology, Rush Presbyterian St. Luke’s Medical Center, Chicago, Illinois; ¶Department of Anesthesiology, State University of New York Health Science Center at Brooklyn, Brooklyn, New York; and #Department of Anesthesia, Duke University Medical Center, Durham, North Carolina

Address correspondence and reprint requests to Susan Hogue, PharmD, MPH, Department of Global Health Outcomes, Glaxo Wellcome Inc., PO Box 13398, Research Triangle Park, NC 27709-3398. Address e-mail to slh17416{at}glaxowellcome.com

	Abstract

Top Abstract Introduction Methods Results Discussion Appendix 1. References

 
The "24-Hour Functional Ability Questionnaire" (24hFAQ) was developed to measure final recovery and satisfaction 24 h after surgery. We used structured interviews preoperatively to measure baseline patient concerns, and up to 24 h after discharge, to assess patient function and satisfaction. The primary objective was to assess the validity of the newly developed 24hFAQ in the postoperative outpatient setting. The criteria assessed were 1) Content: comparison with expert opinion and patients’ views and response frequency distributions for asymptotes and irrelevance, 2) Construct: contribution of cognitive, physical, and satisfaction domains to postoperative functional ability, 3) Discrimination: comparing mean clinical end points with patient satisfaction, and 4) Criterion (predictive) validity: testing that related constructs are best correlated. Content validity was supported by the appropriate frequency distribution of subject responses, by the lack of floor or ceiling effects, and by <2% of responses indicating irrelevance. Construct validity was supported by moderate-to-strong positive interitem correlations within the cognitive and physical domains as predicted a priori. Discriminant validity support was mixed: key symptoms were associated with adverse patient satisfaction, but operating room and postanesthesia care unit residence times were unrelated. Criterion validity was supported by the finding that preoperative concern with key symptoms was independent of postoperative outcomes. The validity assessment presented was the first assessment of the measurement capability of the 24hFAQ in an outpatient postoperative population. These results provide overall support for the validity of the 24hFAQ for use in outpatient populations.

Implications: This study assessed the validity of a novel functional ability questionnaire that measured functional status after recovery from anesthesia and satisfaction 24 h after outpatient surgery. The content, construct, discriminant, and criterion (predictive) validities demonstrated the utility of this assessment instrument in the outpatient setting.

	Introduction

Top Abstract Introduction Methods Results Discussion Appendix 1. References

 
Avoiding an overnight stay after ambulatory anesthesia requires that patients be rapidly discharged home to the care of family or friends. The patients’ ability to resume a normal life postoperatively has thus become important and must be considered in anesthetic planning (1,2). The evidence for patients experiencing difficulty after discharge is well documented. "Minor" adverse events related to anesthesia are as frequent as 88% after outpatient procedures (3–6). Various measures of postoperative functional ability ("home readiness" or "street readiness") have been reported (4–10). However, the ability to walk a straight line or to touch the end of one’s nose with a designated finger merely tests motor function (7), and some more sophisticated instruments are imprecise for adequately assessing the time course of recovery (4–6).

Postoperative nausea and/or vomiting (PONV) after discharge home (i.e., 35% of patients) is a major cause of difficulty returning to normal daily activities (3), and 19% of patients report PONV of at least 24-h duration (4). At 24 h and 48 h postoperatively, approximately 25% of patients report not feeling "back to normal" (5). Drowsiness, dizziness, headache, nausea, and vomiting are also commonly reported as postoperative morbidities.

The 24-Hour Functional Ability Questionnaire (24hFAQ, see Appendix 1) was developed for use in comparing alternative anesthetic regimens. Here, we investigate, by assessing content, construct, discriminant and criterion validities, whether the 24hFAQ is a valid tool for use in the outpatient anesthetic setting.

	Methods

Top Abstract Introduction Methods Results Discussion Appendix 1. References

 
The 24hFAQ was incorporated in the clinical protocol that met ethical and regulatory requirements, including those of the Declaration of Helsinki, Institutional Review Boards approval, and written, informed consent. This large-scale (n = 2438 patients), prospective study compared the intraoperative and recovery profiles of two balanced general anesthesia techniques using either remifentanil or fentanyl. Investigators (n = 159) were relatively unrestricted in their concomitant use of propofol, isoflurane, and nitrous oxide. A randomized, 1:1, parallel-group design was used with 752 and 744 outpatients and 477 and 465 inpatients, randomized to remifentanil- and fentanyl-based treatments, respectively, in a wide variety of clinical settings. The study consisted of two stages: In Stage 1, anesthesiologists familiarized themselves with remifentanil, an ultra-short-acting opioid, by studying 10 open-label patients; these anesthesiologists were already familiar with the use of fentanyl under closely similar clinical conditions. In Stage 2 of the study, remifentanil- and fentanyl-based regimens were compared under controlled conditions. We used Stage 1 of the study to validate the revised 24hFAQ.

Originally, the 24hFAQ began as a method to collect information about resource utilization and the functional status effects of anesthesia. Questions focused on the ability to concentrate, the ability to return to five normal activities, and the need for assistance from friends or family. Early clinical trial results indicated that the original version of the questionnaire was not sensitive enough to determine where recovery differences might be occurring. Thus, it was revised after being used in four focus groups. Three groups had been recently anesthetized for outpatient procedures, and one comprised nurse specialists working in postanesthesia care units (PACU nurses). Patients were asked about activities a) they felt were important on return home from outpatient surgery, b) they found desirable, and c) they had been instructed to avoid on return home. PACU nurses were asked about appropriate criteria for patient discharge as well as other aspects of postanesthetic health. The revised 24hFAQ was then pretested (cognitive debriefing) by the third patient focus group and further reviewed by anesthesia providers before its use in this study.

The current 24hFAQ consists of three components. The first measures patient preoperative expectations about four key symptoms. The second component measures actual occurrence of these key symptoms postoperatively and the ability to return to normal functional activities. The third component assesses patient satisfaction with recovery, satisfaction with the anesthetics administered, and satisfaction with the overall surgical "experience."

In an interview before surgery, patients were asked by a trained clinician to rate their level of concern regarding the occurrence of key symptoms of pain, vomiting, nausea, and/or reduced alertness ("grogginess") on a Likert-type scale ranging from 1 to 4 (no concern to extremely concerned).

Patients rated their ability to perform normal daily activities before surgery, on arrival home, and at 24 h after surgery on a Likert-type scale of 1 to 10 (not able to most able). Patients were asked if they had experienced pain, vomiting, nausea, and/or reduced alertness. If the response was positive, patients were asked to rate these adverse events on a "bothersome" scale of 1 to 4 (not bothered to extremely bothered). If the response was negative, patients were assigned a value of one (i.e., not bothered). Patients also reported times relative to surgery when they were first able to perform a series of daily activities ranging from cognitive (e.g., reading) to physical (e.g., performing light household chores). The 24-h postoperative assessment was administered by a team of trained experts at a contract research organization.

Patients separately rated their satisfaction with anesthetic drugs, quality of recovery, and experience in the outpatient surgical center on a scale of 1 to 7 (extremely satisfied to extremely dissatisfied). Willingness to receive the same anesthetic drugs for any future surgical procedures was recorded as "yes," "no," or "unsure."

The representativeness of items within a measurement tool is the content validity of that instrument (11,12): "Content validity refers to the completeness with which an index covers the important areas of the domain that it is attempting to represent" (13). It is also important that instruments are equally relevant to all members of the patient population, the entire range of anesthetic, and surgical techniques of interest. Results must be meaningful to those who might use them–in this case clinicians and health care managers. The content validity was assessed by expert opinion from thought leaders, clinicians, and individuals within the target population to ensure that questions were appropriately representative of the theoretical construct and relevant to the patients and physicians. Input from key thought leaders and three focus groups were used to validate questions before administering the instrument to patients. Frequency distributions of the patient data for each item were examined for floor or ceiling effects: missing values and responses such as "do not remember" that would indicate a lack of relevance or response bias.

Construct validity, the extent to which items within the cognitive, physical, and satisfaction domains affected the overall construct of postoperative functional ability, was assessed by comparing interitem correlation patterns with their a priori hypothesized relationships (11–15). A very strong correlation between items (r > 0.80), however, is an indication of redundancy (measuring the same thing), and is therefore not desirable. In contrast, if all correlations are near zero, there is no meaningful construct (15).

Discriminant validity requires differentiation of one multi-item construct from another (12). Within the 24hFAQ, this applies most clearly to patient ratings of satisfaction. Discriminant validity was assessed by using mean values of clinical end points that were compared across the levels (extremely satisfied to extremely dissatisfied) of satisfaction indicated by the patients for recovery, anesthetics, and overall surgical experience. The clinical endpoints used from the study are time in the operating room (OR), time in the PACU, and occurrence of key symptoms determined a priori.

Multi-item constructs that are thought to be most closely related should be most highly correlated (11,15). For the 24hFAQ in the anesthetic setting, criterion validity most clearly applies to subject ratings of satisfaction as affected by level of preoperative concern and postoperative experience with the four postoperative adverse events: pain, nausea, vomiting, and grogginess. Thus, the impact of preoperative concern, postoperative experience (bother), and discordance between concern and experience on patient satisfaction with anesthesia drug and recovery were evaluated by using a Spearman rank correlation and Mantel-Haenzel ² test. Logistic regression was used to determine which of the three factors (preoperative concern, surgical experience, and discordance between concern and experience) are good predictors of patient satisfaction. The regression analysis was performed by reducing the seven levels of satisfaction to three levels then two levels.

	Results

Top Abstract Introduction Methods Results Discussion Appendix 1. References

 
Complete questionnaire data were available for analysis for 1334 of 1423 patients who were enrolled in Stage 1 of the study at 150 investigative sites. The study population was predominantly female (60.6%) and Caucasian (81.3%), with a mean age of 40.5 yr.

The frequency distribution of responses for each question within the 24hFAQ showed no evidence of floor or ceiling effects. For the item assessing ability to do light housework and care for children, 2% of patients responded "did not attempt." Otherwise, <1% of all items were reported with the irrelevant responses "did not attempt" or "do not remember." These results suggest that each of the items in the questionnaire was relevant to patients.

Interitem correlation was used to assess construct validity of the 24hFAQ within cognitive, physical, and satisfaction domains. The hypothesis that items within each domain would exhibit moderate-to-strong positive correlation was supported for items within the cognitive domain (Table 1). For the physical domain (Table 2), all correlation coefficients were moderate-to-strong in the positive direction. Within the satisfaction domain, all correlation coefficients were again moderate to strong in the positive direction (Table 3).

It was hypothesized that the three satisfaction measures (satisfaction with anesthetic drugs administered during surgery, quality of recovery, and overall surgical experience) depend on preoperative expectation (measure of concern) and postoperative experiences (measure of bother). The impact of preoperative concern, surgical experience, and discordance between concern and experience on patient satisfaction with anesthesia drug and recovery were evaluated by using a Spearman rank correlation, Mantel Haenzel ² test, and logistic regression. No association was seen between concern and either types of satisfaction; correlation coefficients were less than 0.10 and not statistically significant. An association between levels of experience and patient satisfaction was statistically significant for all four adverse events in this outpatient population, with correlation coefficients ranging from 0.10 to 0.36; P < 0.01. Correlation coefficients for the discordance between experience and concerns were also statistically significant, ranging from 0.07 to 0.32 (P < 0.01; see Table 5)

The impact of preoperative concern on subsequent surgical experience was evaluated by using a Spearman rank correlation and an ordinal ² statistic. An association between levels of concern and experience was statistically significant for three of the four adverse events: pain, nausea, and vomiting (Table 6).

All of these results were consistent across the three types of satisfaction (anesthesia, recovery, and surgery) and four types of postoperative experiences (pain, nausea, vomiting, and grogginess). These results indicate that patient satisfaction with anesthesia and quality of recovery are independent of preoperative patient concerns and expectations. Postoperative experience with adverse events is the primary determinant of patient satisfaction with anesthesia and recovery, even when considering divergent expectations and actual experiences.

	Discussion

Top Abstract Introduction Methods Results Discussion Appendix 1. References

 
The content, criterion, construct and discriminant validities have been assessed for the 24hFAQ in postoperative outpatients. The instrument appropriately measures the ability of patients to return to normal functioning after surgery and can be used in future studies of similar populations. Overall, these analyses provide support for the content validity of the questionnaire and indicate that these questions are relevant and meaningful to patients and health care providers in the outpatient, general anesthesia setting. Because a trained interviewer administered the questionnaire verbally, awaiting a response to each item, skipped and missing items were not problematic. Floor or ceiling effects were not found for any of the items within the questionnaire, suggesting that the range of responses pro- vided by the questionnaire was appropriate for this patient population. However, our study design precluded assessment of any potential effect of previous anesthetic experience on the questionnaire responses.

For construct validity, the strength and direction of the interitem correlations within the cognitive and physical domains were as predicted. Within the cognitive domain, all correlation coefficients were moderate-to-strong and in the positive direction, ranging from 0.31 to 0.57. The strength of these interitem correlation coefficients may have been weakened by the fact that fewer patients than expected in this sample attempted to read for business or pleasure. Within the physical domain, interitem correlations followed a logical pattern, such as self-sufficiency and the ability to get food and water (r = 0.58) being the most highly correlated. As with the cognitive domain, these correlation patterns provided support for the construct validity of the questionnaire. Furthermore, there was no indication of measurement redundancy because all of the interitem correlation coefficients were less than the redundancy criteria (r > 0.80). Finally, all of the coefficients in both domains were well above zero, which indicated that these items form a meaningful construct.

For discriminant validity, the occurrence of the key symptoms and PACU times did impact satisfaction ratings. Key symptoms and increased length of time in the PACU were expected to negatively affect patient satisfaction, but OR residence times were not. The occurrence of the key symptoms did impact satisfaction ratings, although the number of negative responses was very small, because most subjects rated all three satisfaction indices as extremely satisfied or satisfied. Similarly, longer PACU times resulted in decreased levels of satisfaction. OR residence time was not expected to affect patient satisfaction. However, our results showed a consistent pattern in which those who were most dissatisfied experienced longer OR residence times than those who were satisfied. Although these results provide support for the discriminant validity of the instrument in the occurrence of key symptoms and time spent in the PACU, the consistent relationship with time spent in the OR was surprising and should be explored in future studies.

For criterion (predictive) validity, it was expected that preoperative concern and postoperative experience with pain, nausea, vomiting, and grogginess would be strong predictors of patient satisfaction. Surprisingly, this was not always the case. Preoperative levels of concern did not play a major role in overall levels of postoperative satisfaction. This suggests that preoperative bias does not influence postoperative scoring and that the latter is a reasonably objective measurement. This finding contrasts with the view of Lawrence et al. (15) who concluded that postoperative adverse events, advice received by the patient, and preoperative expectations make it difficult to assess return to normal functioning.

We did not attempt to use the same instrument in neurosurgical patients who were taking part in the underlying clinical trial. In this case, craniotomy is a debilitating procedure, usually followed by a prolonged hospital stay and with secondary disability related to the size and site of the lesion: The 24hFAQ is simply not relevant to this clinical setting. For inpatients, most of whom have hospital stays of less than five days and reside in low-dependency surgical rooms, some of the items from the version of the 24hFAQ used in outpatients may not be relevant; thus, some of the items within the domains would need to be adjusted to meet the different functional needs and desires of patients who have not returned to their homes.

As Nunnally and Bernstein (16) have stated, "the term ‘validity’ denotes the scientific utility of a measuring instrument, broadly statable in terms of how well it measures what it purports to measure." The validity assessment presented in this paper was the first assessment of the measurement capability of the 24hFAQ in an outpatient postoperative population. Our findings provide support for the validity of the 24hFAQ in the outpatient setting.

	Appendix 1.

Top Abstract Introduction Methods Results Discussion Appendix 1. References

 

	Acknowledgments

 
We thank the investigators, other advisory panel members (Michael Roizen, MD, Peter Glass MD), Deborah Thompson, MPH (Project Leader), study site coordinators, and patients who took part in this study.

	Footnotes

 
This study was sponsored by Glaxo Wellcome Inc. (Research Triangle Park, NC) under protocol number USAA4001.

	References

Top Abstract Introduction Methods Results Discussion Appendix 1. References

 

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Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999