SCIENTIFIC ARTICLE
The Influence of Patients’ Participation in Research on Their Satisfaction Lauren A. Barber, BA, Michiel G. J. S. Hageman, MD, John D. King, BA, Stijn Bekkers, BSc, Arjan G. Bot, MD, David Ring, MD
Purpose To determine if there was a difference between patients participating in research and those who did not regarding their satisfaction with the medical encounter and their physician. Methods We prospectively randomized 128 patients to either complete 20 minutes of questionnaires (participate in research) or not. After the visit, all patients rated their satisfaction with their visit and satisfaction with the doctor on an 11-point ordinal satisfaction scales, with 0 being not at all satisfied and 10 being completely satisfied. Average satisfaction scores were analyzed in relation to demographics, questionnaires, and involvement in research. Results There were no significant differences between patients that did and did not participate in research for satisfaction with the medical encounter or satisfaction with the treating physician. Satisfaction was not associated with marital status, work status, or diagnosis. There was a significant correlation between greater satisfaction and both less education and lower self-efficacy. There was no significant correlation between patient satisfaction and magnitude of disability, pain intensity, or health anxiety. Conclusions This study demonstrated that patients’ participation in research can coexist with patient satisfaction. (J Hand Surg Am. 2014;-:-e-. Ó 2014 American Society for Surgery of the Hand All rights reserved.) Type of study/level of evidence Prognostic I. Key words Clinical research, hand surgery, patient satisfaction, questionnaires.
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CIENCE PROVIDES INFORMATION for the medical decisions of patients and health care providers. In an age in which patient satisfaction is increasingly measured and even used to determine reimbursement, we were curious whether participation in research decreased satisfaction. Research involving questionnaires adds time to the visit and may be distracting and burdensome. Although many patients enjoy helping
inform and advance medicine, a few seem burdened even when they volunteer. This investigation tested the null hypothesis that there was no significant difference in satisfaction between patients who participated in observational research and those who did not. Secondary hypotheses assessed the relationships between satisfaction and age, disability, pain intensity, pain self-efficacy, and health anxiety.
From the Orthopaedic Hand Service, Massachusetts General Hospital, Boston, MA. Received for publication February 4, 2014; accepted in revised form April 15, 2014. M.G.J.S.H. is supported by Dutch research grants from Marti-Keunig Eckhart Stichting and Anna Foundation (identification number br2012/06). Corresponding author: David Ring, MD, Orthopaedic Hand Service, Yawkey Center, Suite 2100, Massachusetts General Hospital, 55 Fruit St., Boston, MA 02114; e-mail:
[email protected]. 0363-5023/14/---0001$36.00/0 http://dx.doi.org/10.1016/j.jhsa.2014.04.032
MATERIALS AND METHODS All adult (at least aged 18 years), English-speaking patients visiting the Orthopaedic Hand and Upper Extremity Service for the first time between February 2013 and April 2013 were invited to participate in this institutional review boardeapproved randomized controlled trial. Pregnant females were excluded from
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participating. Patients were blinded for study objectives and were informed that the treating physician assessed only deidentified data. Informed consent was obtained. Subjects were randomized either to the intervention cohort (cohort 1), which completed a set of questionnaires during their visit (w20 additional min of time), or to the control group (cohort 2), which was not subjected to a set of questionnaires. The randomization was determined after informed consent using a computerized randomization process. Patients completed the study in a single office visit. Patients that were given questionnaires completed an 11-point ordinal rating of intensity, Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH), Pain Self-Efficacy Questionnaire (PSEQ-2), and Short Health Anxiety Inventory (SHAI). Patients in both cohorts rated their satisfaction with both the visit and the treating physician on an 11-point ordinal satisfaction scale. A total of 128 patients were assessed for eligibility. All agreed to participate, provided informed consent, and were randomized into 64 patients in each cohort. Cohort 1 consisted of 31 men and 33 women, and cohort 2 consisted of 28 men and 36 women. The mean age of participants in cohort 1 was 51 years (SD ¼ 18), and that of cohort 2 was 52 years (SD ¼ 17). There were no significant differences in demographics or final diagnoses between the cohorts (Appendix A, available on the Journal’s Web site at www.jhandsurg.org).
the subject selects the statement that best reflects her or his feelings over the last 6 months. Each item is scored on a scale from 0 to 3, with total scores ranging from 0 to 15.3 A higher total score reflects more health anxiety.4 Satisfaction with the physician and the visit was measured for both cohorts using 11-point ordinal scales, ordinal scale for satisfaction with the doctor and ordinal scale for satisfaction with the visit, with 0 being not at all satisfied and 10 being completely satisfied. Statistical analysis An a priori power analysis for our primary study question indicated that a sample size of 64 patients in cohort 1 and 64 patients in cohort 2 would provide 80% statistical power, with alpha ¼ 0.05, to detect a 0.50 (medium) difference in satisfaction with a 2tailed independent samples t-test. Continuous data were presented as the mean when normally distributed. To determine if there is a difference in satisfaction with the medical encounter between patients participating in clinical research and patients who did not, we performed a Mann-Whitney U test. We used an analysis of variance to test for differences in satisfaction by age, sex, marital status, work status, physician, and diagnosis. All variables with near-significant (P < .08) relationships were evaluated with linear regression using the backward conditional method to assess predictors of satisfaction.
Evaluation parameters An 11-point ordinal rating was used to measure pain intensity. This is an ordinal scale that asks patients to rate their pain from 0 (indicating no pain) to 10 (indicating the worst pain ever). The QuickDASH questionnaire was used to measure upper extremityespecific disability. This questionnaire consists of 11 questions from the 30-item DASH outcome questionnaire. The questions are answered on a 5-point Likert scale. Scores are scaled from 0 to 100, with a higher score representing greater disability.1 The PSEQ-2 is a 2-item instrument used to measure self-efficacy (confidence to function normally despite current levels of pain). Each item employs a 7-point ordinal confidence scale, with 0 being not at all confident and 6 being completely confident. Thus, total scores can range from 0 to 12 with a higher score indicating greater self-efficacy.2 Health anxiety was measured using the SHAI. This questionnaire consists of 5 items used to assess the degree of the patient’s anxiety in medical and nonmedical contexts.3 Each item consists of 4 statements in which J Hand Surg Am.
RESULTS There were no significant differences in satisfaction with the visit (9.3, SD ¼ 1.5 vs 9.2, SD ¼ 1.7; P ¼ .66) or satisfaction with the treating physician (9.3, SD ¼ 1.6 vs 9.5, SD ¼ 1.1; P ¼ .48) between the 2 cohorts. Satisfaction with the visit and with the physician was not associated with demographic factors or diagnosis (Appendix B, available on the Journal’s Web site at www.jhandsurg.org). Among patients completing questionnaires, there were no significant associations between satisfaction with the visit and age, disability, pain intensity, or health anxiety. However, there was a small but significant correlation between greater satisfaction with the visit and both less education (r ¼ 0.34, P < .01) and lower pain self-efficacy (r ¼ 0.26, P ¼ .04). Similarly, there were no significant correlations between satisfaction with the treating physician and age, disability, pain intensity, or health anxiety. However, there was again a significant correlation between greater satisfaction with the treating physician and less education (r ¼ 0.45, P < .001). r
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DISCUSSION This study examined overall patient satisfaction with the physician and the medical encounter in relation to involvement with research. We found that participation in observational research did not diminish patient satisfaction in an academic medical center. Greater satisfaction correlated with less education and less self-efficacy. This study should be considered in light of its shortcomings. First, the findings may only apply to brief, observational, noninvasive, single-episode research in a hand surgery office. Studies that involve randomization of treatment, evaluations at later visits, or research-only office visits might have different findings. Second, participants were enrolled during visits to doctors at a tertiary care institution. It is possible that patients seeing these doctors were aware that they do research and were more prepared to participate. Third, the research assistant was not blinded for the research objectives and hypotheses, which introduced the possibility of influencing the primary outcome by being more or less enthusiastic to different cohorts. Another limitation of our study was the possibility of the Hawthorne effect. Patients experience additional attention during data collection; when combined with surveys highlighting satisfaction, this may lead to a patient’s positive perception of the service.5 The correlation between less education and greater satisfaction is consistent with other studies.6 For instance, Anderson and Zimmerman7 found lower education was the only variable related to greater patient satisfaction. Perhaps people with higher levels of education are more critical of their care and visit experience. Prior studies have shown greater satisfaction with higher self-efficacy.8 Previous work by our team demonstrated that treatment satisfaction 2 months after patients visited the outpatient clinic was significantly correlated with greater self-efficacy. Another study found that those with lower self-efficacy were at greater risk of experiencing dissatisfaction when given health information before a potential surgery.9 Perhaps patients with less self-efficacy in our current study were reassured about their physical function during the consult or may have been given extra attention and experienced greater satisfaction. The absence of significant relationships between satisfaction and disability and health anxiety is inconsistent with previous research, which found higher levels of disability and worse self-perceived overall health were associated with greater dissatisfaction with medical care and providers.10,11 In addition, a significant inverse correlation has been shown between anxiety and
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patient satisfaction.12 Previous studies have also demonstrated a strong relationship between satisfaction, mental health, and pain.13 Because these were secondary study questions and were completed by only half the patients, the analysis was likely underpowered. The relationship between patient satisfaction and pain intensity has been inconsistent in prior research. Identical to our findings, some studies of patients in pain management clinics found no significant correlations between satisfaction and pain intensity.14e16 Other studies have found a significant inverse relationship between patient satisfaction and pain intensity.17,18 There may be differences according to the reasons for pain (eg, trauma vs nontrauma pain). Given our high volume of research and the increasing emphasis on patient satisfaction, we felt it was important to ensure participating in research would not decrease patient satisfaction. Satisfaction is considered an important patient-centered measure of quality and delivery of care and is increasingly considered in institutional compensation and accreditation.18 Because patientphysician interactions have been demonstrated to affect the outcome of care,17 it is important to optimize patients’ satisfaction with their doctors and visits. Further studies are needed to address the impact of other types of research, such as those that require follow-up, invasive interventions, or lengthier questionnaires, on patient satisfaction. REFERENCES 1. Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2001;14(2):128e146. 2. Bot AG, Nota SP, Ring D. The creation of an abbreviated version of the PSEQ: the PSEQ-2. Psychosomatics. 2013 Oct 4. Epub ahead of print. http://dx.doi.org/10.1016/j.psym.2013.07.00. 3. Salkovskis PM, Rimes KA, Warwick HM, Clark DM. The Health Anxiety Inventory: development and validation of scales for the measurement of health anxiety and hypochondriasis. Psychol Med. 2002;32(5):843e853. 4. Alberts NM, Hadjistavropoulos HD, Jones SL, Sharpe D. The Short Health Anxiety Inventory: a systematic review and meta-analysis. J Anxiety Disord. 2013;27(1):68e78. 5. Sitzia J, Wood N. Patient satisfaction: a review of issues and concepts. Soc Sci Med. 1997;45(12):1829e1843. 6. Hall JA, Dornan MC. Patient sociodemographic characteristics as predictors of satisfaction with medical care: a meta-analysis. Soc Sci Med. 1990;30(7):811e818. 7. Anderson LA, Zimmerman MA. Patient and physician perceptions of their relationship and patient satisfaction: a study of chronic disease management. Patient Educ Couns. 1993;20(1):27e36. 8. Gruber J, Hageman M, Neuhaus V, Mudgal CS, Jupiter J, Ring D. Patient activation as a predictor of outcome in an orthopaedic hand and upper extremity clinic. J Hand Surg Am. 2014 (accepted for publication).
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14. Ward SE, Gordon D. Application of the American Pain Society quality assurance standards. Pain. 1994;56(3):299e306. 15. Miaskowski C, Nichols R, Brody R, Synold T. Assessment of patient satisfaction utilizing the American Pain Society’s Quality Assurance Standards on acute and cancer-related pain. J Pain Symptom Manage. 1994;9(1):5e11. 16. Phillips S, Gift M, Gelot S, Duong M, Tapp H. Assessing the relationship between the level of pain control and patient satisfaction. J Pain Res. 2013;6:683e689. 17. Kaplan SH, Greenfield S, Ware JE Jr. Assessing the effects of physician-patient interactions on the outcomes of chronic disease. Med Care. 1989;27(3 Suppl):S110eS127. 18. Urden LD. Patient satisfaction measurement: current issues and implications. Lippincotts Case Manag. 2002;7(5):194e200.
9. Zhong T, Hu J, Bagher S, et al. Decision regret following breast reconstruction: the role of self-efficacy and satisfaction with information in the preoperative period. Plast Reconstr Surg. 2013;132(5): 724ee734e. 10. Patrick DL, Scrivens E, Charlton JR. Disability and patient satisfaction with medical care. Med Care. 1983;21(11):1062e1075. 11. Hall JA, Milburn MA, Epstein AM. A causal model of health status and satisfaction with medical care. Med Care. 1993;31(1): 84e94. 12. Rahmqvist M. Patient satisfaction in relation to age, health status and other background factors: a model for comparisons of care units. Int J Qual Health Care. 2001;13(5):385e390. 13. Cohen G. Age and health status in a patient satisfaction survey. Soc Sci Med. 1996;42(7):1085e1093.
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APPENDIX A.
Demographics Research Group
Parameter
Mean
No Research Group Range
Mean
Range
52
20e81
Age
51
19e82
Education
15
12e22
Sex
n
%
n
%
Men
31
48
28
44
Women
33
52
36
56
22
34
24
38
5
8
0
0
Marital Status Single Living with partner Married
28
44
28
44
Separated/divorced
7
11
9
14
Widowed
2
3
2
3
Working, full time
34
53
Working, part time
7
11
Work status
Homemaker
1
2
10
16
Unemployed, unable to work
6
9
On workers’ compensation
5
8
Currently on sick leave
1
2
35
55
34
53
0
0
1
2
Unemployed, able to work
Diagnosis Acute injury Nonspecific arm pain Trigger finger
1
2
4
6
Carpal tunnel syndrome
3
5
3
5
Ganglion cyst
6
9
0
0
Arthrosis
7
11
8
13
de Quervain tendinopathy
0
0
2
3
Epicondylitis
2
3
1
2
Olecranon bursitis
1
2
0
0
Ulnar neuropathy
3
5
1
2
Peripheral neuropathy
0
0
1
2
Other
6
9
9
14
Physician Physician I
8
13
19
30
Physician II
14
22
13
20
Physician III
30
47
23
36
Other physicians
12
19
9
14
Questionnaires Quick DASH
Mean
Range
39
0e95
PSEQ-2
9.7
1e12
Pain intensity (0e10)
4.6
0e10
SHAI-5
4.6
1e12
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APPENDIX B.
Bivariable Analysis Satisfaction With the Doctor (n ¼ 128)
Satisfaction With Visit (n ¼ 128) Mean
SD
No research group
9.2
1.7
Research group
9.3
1.5
Women
9.2
0.19
Men
9.3
0.2
Parameter
P
Mean
SD
P
9.3
1.6
.48
9.5
1.1
9.3
1.3
9.4
1.4
Cohort .66
Sex .6
.81
Marital status Single
9.1
2.0
9.2
1.9
Living with partner
8.4
3.0
9.6
0.89
Married
9.3
1.1
Separated/divorced
9.3
1.3
Widowed
10
.56
0.0
9.4
1.1
9.5
0.63
10
.65
0
Work status Working, full time
9.3
1.4
9.6
0.66
Working, part time
9.7
0.5
9.4
0.79
Homemaker Unemployed, able to work Unemployed, unable to work
10
0.0
9.5
1.1
7.8
3.1
10 .57
0
9.2
1.3
8.8
2.9
On workers’ compensation
10
0.0
10
0
Currently on sick leave
10
0.0
10
0
.64
Diagnosis Acute injury
9.3
Nonspecific arm pain
10
Trigger finger
1.7
9.3
0.0
10
1.6 0
98.4
0.9
9.6
0.89
Carpal tunnel syndrome
9.7
0.5
9.7
0.52
Ganglion cyst
8.5
2.8
9.8
0.41
Arthrosis
9.4
1.1
9.5
0.74
8
2.8
de Quervain tendinopathy
8.5
.44
2.1
Epicondylitis
10
0.0
10
0
Olecranon bursitis
10
0.0
10
0
Ulnar neuropathy Peripheral neuropathy
9.5
9.3
1.19 1.4
1.4
9
9.3
0.0
10
Physician I
9.4
1.3
Physician II
9.3
1.5
Physician III
9.2
1.4
9
2.4
Other
10
0.7
.97
0
Physician
Other physician Spearman correlation Age Education QuickDASH
.77
Correlation
9.3
1.3
9.6
0.89
9.4
1.2
9.3
2.2
.86
P
0.06
.53
0.34
< .01
L0.45
< 0.001
.3
0.04
0.73
0.13
0.085
0.34
(Continued)
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APPENDIX B.
Bivariable Analysis (Continued) Satisfaction With Visit (n ¼ 128)
Parameter PSEQ-2
Mean
Satisfaction With the Doctor (n ¼ 128)
SD
P
0.26
Mean
SD
.04
0.07
0.57
Pain
0.21
.1
0.067
0.6
SHAI-5
0.11
.4
0.0032
0.98
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P