Abstract
Background and aims and method: Although Infliximab is a very potent therapy of refractory Crohn's disease, its administration requires iterative infusions in hospital and there are concerns regarding its long-term safety. The aim of this study was to assess in a sample of 51 patients suffering from CD the impact of type of treatment (intravenous Infliximab versus conventional therapy without Infliximab) on the evaluation of the state of health (CGI) and the quality of life (MOS-SF36). Secondary variables were also assessed: the impact of depression (MADRS), the impact of activity of the disease (Harvey–Bradshaw Index).
Results: Overall, the assessments made using the CGI and the SF-36 revealed that the two types of treatment did not differ on the assessment of state of health and quality of life. A downward influence of depression and activity of the disease was observed.
Conclusion: Patients considered more efficacy of Infliximab than its potential side effects. It seems important to assess and to consider depression in order to improve medical care setting of Crohn's disease.
1. Introduction
Crohn's Disease (CD) is a chronic intestinal inflammatory disease yet without curative treatment. Steroids, immunosuppressants, and surgery are the main therapeutic tools. The quality of life of CD patients is poor. 1 – 4 Infliximab, developed from 1997, has improved markedly the management of most severe or refractory forms of the disease. 5 – 8 Infliximab may control completely the symptoms of the disease, abrogate the need for steroids and other immunosuppressants, and decrease the operation rate. Its impact on quality of life of patients has been evaluated in few reports. 9 – 11
The major disadvantage of Infliximab given in infusion as a scheduled treatment is to obligate the patient to come to hospital every 6 to 8 weeks. Actually, perception of state of health (CGI) and quality of life (SF36) should be slightly better for patients with oral treatment. Associated depression and disease activity may also embed quality of life.
The aim of this study was to assess the impact of Infliximab on subjective quality of life and on the evaluation of the state of health.
2. Methods
2.1. Patients
Fifty-one consecutive patients with CD, monitored as outpatients in a Paris hospital department, were included into the study. Exclusion criteria were active disease requiring hospitalization and a permanent stoma. All the participants were informed of the objectives of the research and gave their free, informed consent.
Table 1 gives the socio-demographic and clinical characteristics of the subgroups which were formed on the basis of the type of treatment.
2.2. Tools
The Clinical Global Impression (CGI) 12 is a scale consisting of 3 independent items, which are used, in almost all studies in which medical care or the effectiveness of a drug is evaluated. The first item (CGI1 1
1 = normal, not ill at all; 2 = at limit; 3 = slightly ill; 4 = moderately ill; 5 = clearly ill; 6 = seriously ill; 7 = one of the most ill patients (not used in this study).
1 = Very great improvement; 2 = great improvement; 3 = slight improvement; 4 = p no change; 5 = slight aggravation; 6 = great aggravation; 7 = very great aggravation.
The MOS-SF36 is a general questionnaire which makes it possible to collect the patients' point of view concerning their own state of health. 13 , 14 This self-questionnaire contains 36 questions subdivided into eight dimensions (not counting the perceived development of the state of health) each of which corresponds to a different aspect of health (Physical Functioning [PF], Role Physical [RP], Bodily Pain [BP], General Health [GH], Vitality [VT], Social Functioning [SF], Mental Health [MH], Role Emotional [RE], Health Transition [HT]). This scale was chosen because it is able to detect unexpected disease impact and above all, it has got a detailed psychological quality of life scale. This dimension is fundamental for this study and a specific instrument is not able to explore this dimension in an exhaustive way.
The Montgomery and Asberg Depression Rating Scale (MADRS) is a simple, short, easy-to-use self-evaluation scale. 15 – 18 It is sensitive to change, differentiates well between the different degrees of severity of depression and therefore represents a good overall index. The predominance of mental items over somatic items favors its use with patients exhibiting a somatic disorder in order to eliminate interference. The threshold depression score in the MADRS is 15.
The activity of the disease: the senior physician assessed the activity or inactivity of the disease with the Harvey–Bradshaw Index. 19 This index correlated closely with the Crohn's disease activity index (CDAI) and is simpler to use. It consists of clinical parameters (wellbeing, abdominal pain, number of liquid stools per day, abdominal mass and complications). A total score below 4 signs an inactive disease and a score equal or superior to 4 an active disease.
2.3. Processing of the data
The effects of treatment (CO vs IV) and of depression (D vs. ND) were tested using a Student t test for independent groups. We thus compared CGI and SF36 in CD patients receiving scheduled infusions of Infliximab with patients receiving current oral therapies. We used a simple Anova to evaluate the effect of the disease. The post-hoc analyses were performed using a Fischer test. Considering the number of comparisons, the Bonferroni correction was applied and a P value of <.01 was considered statistically significant.
3. Results
3.1. Effect of mode of treatment
The mode of treatment had no influence on the various evaluations. There was no difference between the IV group and the CO group on the CGI1 ( p >.05), the CGI2 ( p >.05) or the CGI3 ( p >.05) ( Fig. 1 ). Patients treated with Infliximab considered themselves moderately ill and considered that the treatment improved them strongly ( Table 2 ). Above all, they considered that Infliximab as conventional treatment had a strong therapeutic effect but with side effects interfering with usual functioning. Patients did not seem to consider that side effects were so disturbing that they would reconsider the perceived benefit of the treatment.
No quality of life dimension 3
PF: t = −0.45, p = .65, ddl = 48; RP: t = 0.77, p = .44, ddl = 48; BP: t = 0.54, p = .59, ddl = 48; GH: t = 1.21, = .23, ddl = 48; VT: t = 1.15, p = .26, ddl = 48; SF: t = 1.13, p = .26, ddl = 48; RE: t = 0.42, p = .67, ddl = 48; MH: t = 0.27, p = .79, ddl = 48; PF: t = −0.45, p = .65, ddl = 48.
3.2. Effect of secondary variables
Only outstanding results are described in this part. Detailed results are described in endnotes.
3.3. Effect of depression
The results are presented in Table 3 .
Depression was assessed with the MADRS (the depressive group D corresponds to patients exhibiting a depressive disorder and ND to non-depressive patients on the basis of a threshold score of 15 15 – 18 ).
The mean score across the entire sample showed that the patients were not depressed. There was a very highly significant difference between the group of non-depressed patients and the group of depressed patients ( t = −1.8; p = .000, ddl = 48).
From a general point of view, the mean result on the CGI 1 shows that the patients considered themselves to be moderately ill. The result for item 2 of the CGI shows that they considered that the medical care had greatly improved their state of health. Finally, the combined score for the therapeutic effectiveness of the treatment and the side effects (item 3 of the CGI) shows that, while the patients considered that the treatment permitted the almost complete disappearance of the symptoms, they believed that the side effects interfered with their normal functioning. As far as the effect of depression is concerned, we did not observe any significant difference between the two groups (N vs ND) in terms of their assessment of the severity of the disorders (CGI1). Whether depressive or not, the patients considered themselves to be moderately ill. Depression therefore had no impact on the patients judgment of their own state of health. We did not observe a significant difference in their evaluation of the overall improvement in their state of health (CGI2) ( p >.01). However we observed a significant difference between the two groups in terms of their combined evaluation of the therapeutic effect and side effects ( t = −2.70; p = .009, ddl = 48). Indeed, while both the depressive and the non-depressive patients considered that treatment had a major therapeutic effect, the depressive patients nevertheless thought that the side effects were difficult to cope with (meanD = 4.91, SD = 3.39) whereas the non-depressive patients thought that they had no impact on their usual functioning (meanND = 2.5, SD = 2.34). In other words, depression had an effect on the way these patients evaluated the impact of therapeutic effect and side effects (CGI3). In contrast, they underestimated neither the effectiveness of the treatment nor the improvement in their state of health. They had a slightly more finely-shaded point of view than the non-depressive patients.
Depression had an impact only on one physical dimension (vitality) and on all psychological dimensions. 4
The patients did not feel that they were limited in their physical activities (PF). They were not, overall, inconvenienced in the accomplishment of their everyday tasks. This dimension of quality of life was not influenced by depression ( p >.05). The limitations due to their physical state (RP) were relatively modest. These were not influenced by depression ( t = 3.23, p = .002, ddl = 48). The depressed patients perceived their illness to have a much more negative impact on their everyday activities than the non-depressed patients. Even though, in general terms, physical pain (BP) was present, it was not a major consideration. Depression had no influence on this dimension ( p >.05). From a general point of view, perceived health (GH) was poor but was not influenced by depression ( p <.05). In general, the patients described themselves as tired (VT). It is logical for this dimension to be influenced by depression ( t = 4.89, p = .00001, ddl = 48). If patients are already fatigued by Crohn's disease then this fatigue will be exacerbated by depressive asthenia. Relations with others (SF) were generally perceived as being impaired by the state of health and severely so amongst the depressive patients ( t = 3.97, p = .0002, ddl = 48). While the patients considered their mental state (MH) to be average, this was evidently influenced by depression ( t = 5.31, p = .000003, ddl = 48). Constraints relating to mental problems (RE) were present to a moderate extent. In contrast, it is quite logical that these were influenced by depression ( t = 4.35, p = .00007, ddl = 48). Finally, the perceived development of health (HT) had a global level of 2.94. The patients therefore tended to consider that their state of health was better than the year before (close to a similar state). This evaluation was not modified by depression ( t = 0.83, p = .41, ddl = 49). In general terms, the scores obtained on the dimensions of the MOS-SF36 are consistent with those observed in other studies (Colombel et al., 1996; Moreno-Jimenez et al., 2007).
3.4. Effect of activity of the disease
The results are presented in Table 3 .
The activity of the disease was assessed on the basis of a threshold score of 4 in the Harvey–Bradshaw Index. 19A corresponds to patients with an active disease and I to patients with inactive disease.
The evaluation of depression differed significantly according to disease activity ( t = 2.53, p = .01, ddl = 49). Nevertheless, patients with active disease were not depressed: although their scores were higher, they did not reach the threshold depression score.
We observed significant differences between the two groups in terms of their assessment of the severity of the disorder (CGI1: t = 2.60, p = .012, 49ddl). Patients with active disease considered themselves to be moderately ill (meanA = 3.95, SD = 1.39), whereas those inactive considered themselves to be slightly ill (meanI = 2.90, SD = 1.47). Thus activity of the disease had an impact on the patient judgment of his own state of health. We also observed a significant difference in their evaluation of the overall improvement in their state of health (CGI2) ( t = 3.99; p = .0002, ddl = 49): the patients with active disease considered that their state of health had improved slightly (meanA = 3.14, SD = 1.42) whereas the patients with inactive disease considered that it had improved greatly (meanI = 1.79, SD = 0.98). We did not observe a significant difference for the combined evaluation of the therapeutic effect and the side effects (CGI3). 5
In fact there was a difference slightly significant between the two groups in terms of their combined evaluation of the therapeutic effect and the side effects (CGI3) ( t = 2.43; p = .019, ddl = 49). In effect, the patients with active disease thought that the treatment is moderately effective and that the side effects were difficult to cope with (meanA = 4.05, SD = 3.21) whereas the patients with inactive disease thought that it is effective and that they had no impact on their usual functioning (meanI = 2.24, SD = 2.08).
The quality of life evaluation showed a difference between the two groups. 6
The patients did not feel that they were limited in their physical activities (PF). They were not, overall, inconvenienced in the accomplishment of their everyday tasks. This dimension of quality of life was not influenced by activity of the disease ( p >.05). The limitations due to their physical state (RP) were important for the patients with an active disease (meanA = 45.45, e–t = 39.82; meanI = 76.72, e–t = 28.29). These were influenced by activity of the disease ( t = −3.28, p = .0019, ddl = 49). The patients with active disease perceived their illness to have a much more negative impact on their everyday activities than the patients with inactive disease. Even though, in general terms, physical pain (BP) was present, activity of disease had no influence on this dimension ( p >.05). From a general point of view, perceived health (GH) was poor but was not influenced by activity of the disease ( p .05). In general, the patients described themselves as tired (VT). But surprisingly this dimension was not influenced by activity of the disease ( p >.05). Patients are fatigued by Crohn's disease independently of activity of the disease. Relations with others (SF) were perceived as being impaired by the state of health and most severely for the patients with active disease ( t = −3.13, p = .0029, ddl = 49). While the patients considered their mental state (MH) to be average, this was influenced by activity of the disease ( t = −2.96, p = .0047, dll = 49). For these patients, activity of the disease has a major impact on mental state (meanA = 45.25, e–t = 23.82; meanI = 63.31, e–t = 19.66). Constraints relating to mental problems (RE) were present to a moderate extent for patients with inactive disease (meanI = .79.31, e–t = 32.63). But it is quite logical that these were influenced by disease's activity (meanA = 43.94, e–t = 40.35; ( t = −3.46, p = .0011, ddl = 49). Finally, the patients with inactive disease logically tended to consider that their state of health (HT) was better than the year before (close to a similar state) when the disease is inactive (meanA = 3.4, e–t = 0.85; meanI = 2.59, e–t = 1.12). This evaluation was modified by the activity of the disease ( t = 2.87, p = .006, ddl = 49).
4. Discussion
The results of this study show that neither type of treatment is considered to be more effective than the other. If IV treatment is prescribed for moderate or severe Crohn's disease, patients do not perceive their state of health poorer than patients who received conventional treatment. The most interesting is despite the fear of side effects related to Infliximab, patients consider more the efficacy than the side effects which do not interfere with their usual functioning. This result shows perceived benefit for these patients to take this treatment. It can also be understood that patients overestimate benefit and underestimate risks. 20 They would not consider potential important side effects as fundamental as physician could do.
One may, in effect, wonder whether the patients clinical status does not further significantly impair their evaluations over time. Furthermore, the infusions (beyond their effectiveness) have caused these patients to be observant in adhering to their treatment. In other words, an undoubtedly superior level of adherence to treatment in the case of certain patients coupled with a treatment (frequently effective against resistant Crohn conditions) might result in a quality of life very similar to that experienced by patients receiving a more conventional treatment. Beliefs in efficiency of treatment and the improvement it leads could explain both the evaluation of CGI (1 and 2) and this observation (beliefs may be renewed by physician recommendations 21 ). But it appeared that coming once every eight weeks approximately and the conveniences that infusion involves don't affect quality of life and the beliefs that treatment would lead more unpleasant side-effects (CGI3). 22
Disease activity did not seem to change the situation although, of course, an active phase impairs quality of life. 23 – 26 So, the impact of the activity of the disease is more complex than it seems to be. Active periods of the disease are marked by stress and distress. 2 , 27 At the same time, being afflicted by a serious chronic pathology is a major stress factor which increases the risk of anxiety or depression. The presence of a depressive disorder reduces the ability to confront the disease 28 and makes it difficult to follow a course of treatment. 4 , 29
In order to improve medical settings the influence of depression and activity of the disease must be considered. Depression did not modify: the patients' perception of their own state of health, the effectiveness of treatment on this, or the dimensions associated with physical health in the quality of life scale. Finally, the depressive patients were able to distinguish aspects relating to their physical health to those relating to their mental health. Furthermore, the very fact that all the mental dimensions of the scale were much worse is not only consistent with the fact that these patients were experiencing greater mental suffering. It also shows that, while their physical health is of great importance, it is nevertheless framed within a clinical perception that is already characterized by depression. And the influence of activity of the disease on the psychological scales of quality of life confirms this observation. People with active disease would more likely to be depressed and activity of the disease has a pejorative effect on psychic dimension of subjective quality of life assessment. But it seems important to notice that vitality item is influenced by depression and not by activity of the disease. Depression and activity of disease had a major impact on quality of life. 2 , 25 – 27 , 30 But if depression is correlated with activity of the disease 31 , their influence is not the same. If quality of life is worsened with disease severity 26 , disease activity influences psychological dimensions of quality of life and not physical dimensions.
4.1. Financial competing interests
In the past five years the authors did not receive and will not receive any reimbursement, fee, funding or salary from an organization that may in any way gain or lose financially from the publication of this manuscript (either now or in the future).
The authors do not hold any stocks or shares in an organization that may in any way gain or lose financially from the publication of this manuscript (either now or in the future).
Acknowledgements
Authorship.
Ingrid Banovic: the conception and design of the study, acquisition of data, analysis and interpretation of data.
Daniel Gilibert: the conception of the study, analysis of data.
Jacques Cosnes: the conception and design of the study, revising critically the article for important intellectual content, final approval of the version to be submitted.
References
Figures
Results on the CGI as a function of the mode of treatment (IV: intravenous Infliximab administration; CO = conventional treatment). No difference was significant.
Results on the CGI as a function of the mode of treatment (IV: intravenous Infliximab administration; CO = conventional treatment). No difference was significant.
Tables
Sociodemographic and disease-related data summarized for all patients and for the two groups of treatment
| Treatment | ||
| Infliximab (IV) | Conventional (CO) | |
| Number of subjects | 22 | 29 |
| Number of women | 12 | 19 |
| Median age in years | 33.5 | 47 |
| Min | 17 | 21 |
| Max | 69 | 69 |
| Marital status | ||
| Living as couple | 11 | 22 |
| Single | 13 | 5 |
| Divorced | 1 | 2 |
| Education level | ||
| Primary secondary school | 2 | 1 |
| High school | 2 | 4 |
| 9–11 years(CTE) | 6 | 5 |
| High school to master's degree | 10 | 13 |
| >Master's degree | 2 | 6 |
| Employment | ||
| Working | 18 | 17 |
| Retired | 0 | 4 |
| Unemployed | 0 | 1 |
| Incapacitated | 0 | 3 |
| Housewife | 2 | 3 |
| Training | 2 | 1 |
| Median age on onset of symptoms | ||
| Min | 22 | 23.5 |
| Max | 10 | 13 |
| 54 | 53 | |
| Median age at diagnosis | ||
| Min | 22 | 30 |
| Max | 16 | 13 |
| 64 | 55 | |
| Current disease complication at interview | ||
| No complication | 11 | 21 |
| Intestinal stricture | 1 | 6 |
| Perianal fistula | 10 | 2 |
| Conventional treatment | ||
| Immunosuppressant | 21 | 14 |
| Steroids | 0 | 2 |
| Aminosalicylates | 0 | 8 |
| Immunosuppressant + steroids | 1 | 4 |
| Immunosuppressant + steroids + aminosalicylates | 0 | 1 |
| Treatment | ||
| Infliximab (IV) | Conventional (CO) | |
| Number of subjects | 22 | 29 |
| Number of women | 12 | 19 |
| Median age in years | 33.5 | 47 |
| Min | 17 | 21 |
| Max | 69 | 69 |
| Marital status | ||
| Living as couple | 11 | 22 |
| Single | 13 | 5 |
| Divorced | 1 | 2 |
| Education level | ||
| Primary secondary school | 2 | 1 |
| High school | 2 | 4 |
| 9–11 years(CTE) | 6 | 5 |
| High school to master's degree | 10 | 13 |
| >Master's degree | 2 | 6 |
| Employment | ||
| Working | 18 | 17 |
| Retired | 0 | 4 |
| Unemployed | 0 | 1 |
| Incapacitated | 0 | 3 |
| Housewife | 2 | 3 |
| Training | 2 | 1 |
| Median age on onset of symptoms | ||
| Min | 22 | 23.5 |
| Max | 10 | 13 |
| 54 | 53 | |
| Median age at diagnosis | ||
| Min | 22 | 30 |
| Max | 16 | 13 |
| 64 | 55 | |
| Current disease complication at interview | ||
| No complication | 11 | 21 |
| Intestinal stricture | 1 | 6 |
| Perianal fistula | 10 | 2 |
| Conventional treatment | ||
| Immunosuppressant | 21 | 14 |
| Steroids | 0 | 2 |
| Aminosalicylates | 0 | 8 |
| Immunosuppressant + steroids | 1 | 4 |
| Immunosuppressant + steroids + aminosalicylates | 0 | 1 |
Results (mean and SD) on the MADRS, CGI and MOS-SF36 as a function of the mode of treatment (IV: Infliximab by intravenous administration; CO = conventional treatment)
| Treatment | |||
| IV ( n = 22) | CO ( n = 29) | ||
| MADRS | 10.95±9.47 | 7.38±6.55 | |
| MOS-SF36 | PF Physical Functioning | 83.64±19.89 | 81.72±20.06 |
| RP Role Physical | 59.09±37.44 | 66.38±36.76 | |
| BP Bodily Pain | 65.05±28.87 | 67.10±23.19 | |
| GH General Health | 41.59±19.33 | 51.62±22.70 | |
| VT Vitality | 38.41±21.90 | 46.21±21.03 | |
| SF Social Functioning | 60.80±25.67 | 67.67±23.27 | |
| RE Role Emotional | 60.61±43.20 | 66.67±37.80 | |
| MH Mental Health | 53.45±25.37 | 57.10±21.64 | |
| HT Health Transition | 3.13±1.01 | 2.78±1.13 | |
| Treatment | |||
| IV ( n = 22) | CO ( n = 29) | ||
| MADRS | 10.95±9.47 | 7.38±6.55 | |
| MOS-SF36 | PF Physical Functioning | 83.64±19.89 | 81.72±20.06 |
| RP Role Physical | 59.09±37.44 | 66.38±36.76 | |
| BP Bodily Pain | 65.05±28.87 | 67.10±23.19 | |
| GH General Health | 41.59±19.33 | 51.62±22.70 | |
| VT Vitality | 38.41±21.90 | 46.21±21.03 | |
| SF Social Functioning | 60.80±25.67 | 67.67±23.27 | |
| RE Role Emotional | 60.61±43.20 | 66.67±37.80 | |
| MH Mental Health | 53.45±25.37 | 57.10±21.64 | |
| HT Health Transition | 3.13±1.01 | 2.78±1.13 | |
Results (mean and SD) on the MADRS, CGI and MOS-SF36 for the overall sample and as a function of the presence (D = depressed) or absence (ND = non-depressed) of depression and as a function of the activity (A=active disease) or inactivity (I=inactive disease) of the CD
| All patients | Depression | Activity of CD | ||||
| D ( n = 11) | ND ( n = 40) | A ( n = 22) | I ( n = 29) | |||
| CGI | MADRS | 8.92±8.05 | 22.27±4.43 | 5.25±3.75 | 12.05±8.69 | 6.55±6.76 |
| CGI1 | 4.03±1.26 | 4±1 | 4.05±1.34 | 3.95±1.39 | 2.90±1.47 | |
| CGI2 | 2.37±1.35 | 3.36±1.56 | 2.1±1.17 | 3.14±1.42 | 1.79±0.98 | |
| CGI3 | 3.02±2.75 | 4.91 * ±3.39 | 2.5 * ±2.34 | 4.05 ** ±3.21 | 2.24 ** ±2.08 | |
| Mos-SF36 | PF Physical Functioning | 82.55±19.81 | 74.55±22.63 | 84.75±18.67 | 79.32±23.21 | 85±16.79 |
| RP Role Physical | 63.24±36.86 | 34.09±25.67 | 71.25±35.60 | 45.45 ** ± 39.82 | 76.72 ** ±28.29 | |
| BP Bodily Pain | 66.22±25.54 | 56.64±27.30 | 68.85±24.74 | 59.41±26 | 71.38±24.36 | |
| GH General Health | 47.29±21.70 | 41.18±19.94 | 48.98±22.10 | 45.73±21.70 | 48.48±22 | |
| VT Vitality | 42.84±21.55 | 19.55 *** ±11.72 | 49.25 *** ± 19.10 | 37.05±19.25 | 47.24±22.46 | |
| SF Social Functioning | 64.71±24.33 | 42.05 ** ±23.23 | 70.94 ** ±20.88 | 53.41 * ±22.88 | 73.28 * ±22.09 | |
| RE Role Emotional | 64.05±39.91 | 24.24±30.15 | 75±35.20 | 43.94 * ±40.35 | 79.31 * ±32.63 | |
| MH Mental Health | 55.53±23.15 | 29.09 *** ± 17.81 | 62.80 *** ± 18.83 | 45.27 * ±23.82 | 63.31 * ±19.66 | |
| HT Health Transition | 2.94±1.08 | 3.18±1.08 | 2.875±1.09 | 3.41 * ±0.85 | 2.59 * ±1.12 | |
| All patients | Depression | Activity of CD | ||||
| D ( n = 11) | ND ( n = 40) | A ( n = 22) | I ( n = 29) | |||
| CGI | MADRS | 8.92±8.05 | 22.27±4.43 | 5.25±3.75 | 12.05±8.69 | 6.55±6.76 |
| CGI1 | 4.03±1.26 | 4±1 | 4.05±1.34 | 3.95±1.39 | 2.90±1.47 | |
| CGI2 | 2.37±1.35 | 3.36±1.56 | 2.1±1.17 | 3.14±1.42 | 1.79±0.98 | |
| CGI3 | 3.02±2.75 | 4.91 * ±3.39 | 2.5 * ±2.34 | 4.05 ** ±3.21 | 2.24 ** ±2.08 | |
| Mos-SF36 | PF Physical Functioning | 82.55±19.81 | 74.55±22.63 | 84.75±18.67 | 79.32±23.21 | 85±16.79 |
| RP Role Physical | 63.24±36.86 | 34.09±25.67 | 71.25±35.60 | 45.45 ** ± 39.82 | 76.72 ** ±28.29 | |
| BP Bodily Pain | 66.22±25.54 | 56.64±27.30 | 68.85±24.74 | 59.41±26 | 71.38±24.36 | |
| GH General Health | 47.29±21.70 | 41.18±19.94 | 48.98±22.10 | 45.73±21.70 | 48.48±22 | |
| VT Vitality | 42.84±21.55 | 19.55 *** ±11.72 | 49.25 *** ± 19.10 | 37.05±19.25 | 47.24±22.46 | |
| SF Social Functioning | 64.71±24.33 | 42.05 ** ±23.23 | 70.94 ** ±20.88 | 53.41 * ±22.88 | 73.28 * ±22.09 | |
| RE Role Emotional | 64.05±39.91 | 24.24±30.15 | 75±35.20 | 43.94 * ±40.35 | 79.31 * ±32.63 | |
| MH Mental Health | 55.53±23.15 | 29.09 *** ± 17.81 | 62.80 *** ± 18.83 | 45.27 * ±23.82 | 63.31 * ±19.66 | |
| HT Health Transition | 2.94±1.08 | 3.18±1.08 | 2.875±1.09 | 3.41 * ±0.85 | 2.59 * ±1.12 | |
p<.01
p<.001
p<.0001
